Manual Maquina Anestesia Heinen Lowestein Leon Pluss [PDF]

Zitiervorschau

Service Manual leon leonplus

Rev.: 2.3.5 Date: 22.06.2010

Certificate This Service Manual applies only to

leonplus With the Serial No.:

0200010HULXXXXXXX 0200011HULXXXXXXX

leon With the Serial No.:

0200020HULXXXXXXX 0200021HULXXXXXXX

Manufacturer: Heinen + Löwenstein GmbH & Co. KG D-56130 Bad Ems/Germany Arzbacher Straße 80 Telephone : Fax : Internet :

++49 2603 / 9600-0 ++49 2603 / 9600-50

www.hul.de

Reg.-Nr.: 04 207 3552/96

Rev. Date:

2.3.5 22.06.2010 Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.3.5

1

Contents

Revision 1 Contents

2.3.5

2 Safety and warning notices

2.1.1

3 Pneumatic / mechanical modules

2.1.1

4 Electronic modules

2.1.2

5 System software update

2.2.2

6 Maintenance

2.2.2

7 Calibration

2.2.3

8 Testing

2.1.4

9 Repairs

2.3.3

10 Configuration Service

2.1.2

Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.3.5

Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.3.5

Chapter 2: Safety and Warning Notices

2

Safety and warning notices

Contents 2.1 2.1.1 2.1.2

Page General information ..................................................................................... 2-3 Main topics of the service manual ........................................................... 2-3 Structure and purpose of the service manual .......................................... 2-3

2.2 2.2.1.1 2.2.1.2 2.3

Information and warnings ............................................................................ 2-4 Information ......................................................................................... 2-4 Information on dangers....................................................................... 2-4 General safety instructions .......................................................................... 2-5

2.4

Maintenance................................................................................................ 2-7

2.5

Liability for proper function or damage......................................................... 2-7

2.6 2.7

Symbols....................................................................................................... 2-8 Terms and abbreviations ........................................................................... 2-14

Figures Page - none -

Tables Page Table 1: Safety instructions/description ............................................................................ 2-6 Table 2: Symbols/Labels.................................................................................................. 2-9 Table 3: Symbol/Hard key .............................................................................................. 2-10 Table 4: Symbol/LEDs ................................................................................................... 2-10 Table 5: Symbol/Screen (display only) ........................................................................... 2-11 Table 6: Symbol/Screen (control elements).................................................................... 2-11 Table 7: Symbol/Buttons ................................................................................................ 2-12 Table 8: Symbol/Screen (tabs) ....................................................................................... 2-13

Heinen + Löwenstein®, Service Manual leon/leonplus Rev. 2.1.1

2-1

Chapter 2: Safety and Warning Notices

2.1

General information

The documentation for the leon/leonplus anesthesia system comprises: ⇒ leon/leonplus User Manual ⇒ leon/leonplus Service Manual ⇒ leon/leonplus checklist before beginning of operation (see User Manual) ⇒ leon/leonplus quick reference guide (see User Manual) ⇒ leon/leonplus spare part ordering (see User Manual) ⇒ leon/leonplus checklist safety inspection (see User Manual)

2.1.1 Main topics of the service manual This service manual describes repair and maintenance operations. It includes: ƒ

An overview of device components

ƒ

Instructions on software update

ƒ

Instructions of maintenance and calibration

ƒ

Instructions for repairs and testing after repairs or maintenance

2.1.2 Structure and purpose of the service manual The service manual is structured to assist you with repair and maintenance work. Additional it describes test setups for the control of the device. It is intended for trained technicians only. Read the service manual carefully before start working on the device.

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2-3

Chapter 2: Safety and Warning Notices

2.2 Information and warnings 2.2.1 Information Information is provided to supplement the instructions for actions. The information suggests actions that can make it easier and more efficient to operate the ventilator.

2.2.2 Information on dangers Information on dangers must be read at all times to prevent injuries to persons or damage to the inhalant anaesthesia system.

DANGER indicates a latent hazard that is not an immediate threat but if DANGER

precautions are not taken it may cause death or personal injury

CAUTION refers to a hazard that may cause damage to the device if CAUTION

2-4

precautions are not taken.

Heinen + Löwenstein®, Service Manual leon/leonplus Rev. 2.1.1

Chapter 2: Safety and Warning Notices

2.3

General safety instructions

Safety Instruction

Description

Approved service technicians

Service and safety inspections must be conducted only by technicians that we have trained and who have the recommended instrumentation and test equipment.

Follow service manual

Use of this equipment requires full knowledge of and precise adherence to the supplied service manual. The device may be used only for the purpose intended. As the technician performing technical operations on the system, you must be familiar with the operation of the device and its menus. Operating basics are provided in the User Manual and are not addressed in detail here. Any technical operation on the equipment requires full knowledge of and strict adherence to this Service Manual.

Disconnect power

Always disconnect the mains power before opening the housing.

Prevent electrostatic discharge

Electrostatic discharge must be prevented during all work on the device to prevent damage to the components and the device. Take the following precautions before touching a printedcircuit board or a component attached to a pcb. If this precaution is not observed the device may be damaged. ƒ ƒ ƒ ƒ

Use with alternative ventilation system

All work on the device must be done on a suitable earthed and conductive work surface (antistatic, ESD protection). Make sure that you are sufficiently earthed (e.g. 1 MΩ). Earth every instrument used during work on the ventilator. Transport components and printed-circuit boards in the correct antistatic packages only.

While the leon/leonplus is in use, an alternative ventilation system must be available at all times, e.g., an Ambu bag. If a fault is detected on the leon/leonplus inhalation anesthesia system that compromises its life-sustaining function, an independent ventilation device, e.g., an Ambu bag, must be used immediately to ventilate the patient.

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Chapter 2: Safety and Warning Notices

Safety Instruction

Description

Combination with other devices

Combination with other devices that are not mentioned in the user manual is permitted only in consultation with the manufacturer.

Do not use with flammable gases

Do not use the system with flammable gases or anesthetics due to risk of fire.

Perform system function test

If an error is detected during the system function test, the system may not be connected to a patient under any circumstances.

Do not cover or set up inappropriate

Do not cover the system or set it up such that its operation or function is impaired.

Do not use mobile telephones nearby

Do not use mobile telephones within 10 meters (approx. 11 yards) of the system. Mobile telephones can disrupt the function of electromedical devices. Electromagnetic disturbances that exceed the limits defined in EN 60601-1-2 can affect the ability of the anesthesia workstation to function properly.

Do not use antistatic or electrically conductive tubes

Do not use antistatic or electrically conductive tubes.

Table 1: Safety instructions/description

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Heinen + Löwenstein®, Service Manual leon/leonplus Rev. 2.1.1

Chapter 2: Safety and Warning Notices

2.4

Maintenance1

The leon/leonplus is an anesthesia system classified as a Type IIb device according to directive 93/42/EWG, Appendix IX, and belongs to Protection Category I Type B according to EN 60601-1. 1.) Maintenance and a system test as specified by the manufacturer must be performed every 12 months. 2.) 10.000-hour maintenance must be performed according to manufacturer specifications every 3 years or after 10.000 hours of operation. 3.) 20.000-hour maintenance must be performed according to manufacturer specifications every 6 years or after 20.000 hours of operation. 4.) Maintenance may be performed only by trained personnel of Heinen + Löwenstein GmbH, who are equipped with the appropriate measurement and testing equipment. Please contact our hospital sales department to set up a service contract. For maintenance, use only original parts from Heinen + Löwenstein GmbH.

2.5

Liability for proper function or damage

The liability for the proper function of the system is in any case transferred to the owner or operator if the system was improperly maintained or repaired by persons not employed by Heinen + Löwenstein GmbH Service or if the system was not used in the manner intended. Heinen + Löwenstein GmbH is not responsible for damages arising from non-compliance with above recommendations. The above-mentioned recommendations do not extend the warranty and liability provisions of the terms of sale and delivery of Heinen + Löwenstein GmbH.

1

Definition according to DIN 31 501: Inspection = Determination of actual condition Maintenance = Measures to maintain the required condition Service = Measures to restore the required condition Maintenance = Inspection, maintenance, service

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Chapter 2: Safety and Warning Notices

2.6

Symbols Symbols/Labels

Description Follow User/Service Manual labels. Important note Type BF application part label. Type BF: = "Body Floating” insulated application part for use on the body but not on the open heart. Type B application part label. Type B: = "Body" application part for use on the body but not on the open heart. Interference may occur in the vicinity of equipment marked with this symbol

Label. Do not dispose of the electrical or electronic device as normal/regular household waste. For professional disposal, reuse and refurbishment, the product must be taken to a collection site for recycling of electrical and electronic waste. This symbol is valid only in the European Union. Voltage caution label. Unplug the device before opening it. Device should be opened only by qualified personnel.

Potential equalization connection label

Caution! Steps to protect electrostatically sensitive components are required (according to IEC 61340-5-1). Work may be performed only by qualified service personnel.

CE for compliance with EU directive 93/42/EWG for medical devices with identification of certifying body Safety fuse label

Production date label

Manometer for O2 reserve cylinder pressure label (on front)

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Chapter 2: Safety and Warning Notices

Symbols/Labels

Description Manometer for N2O reserve cylinder pressure label (on front) Label for manometer for vacuum pressure (on the front) Label for ON/OFF switch for vacuum (on the front) Label for dial for vacuum control (on the front) Label for pushbutton for O2 flush (on the front) Pneumatic input label (water trap) Electric output label (data communication) Electric input label (pressure sensor for 10 l reserve gas cylinders) Rotating direction close/open External O2 outlet label External fresh gas outlet label with maximum pressure Pmax

ETH COM 1, COM 2

Ethernet interface label Label 1 and 2 for serial interface Table 2: Symbols/Labels

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Chapter 2: Safety and Warning Notices

Symbol/Hard key

Description ON/OFF hard key Select automatic fresh gas control hard key Select real-time graph window hard key Select ventilation parameters window hard key Select MAN./SPONT. ventilation ventilation/spontaneous respiration) hard key

mode

(manual

Display Loops window hard key

Display alarm limits window hard key Hard key browse (switches between the following tabs) Standby

during ventilation

Standby

Real-time charts

Trend charts

Trend charts

Trend tabular

Trend tabular

Event log

Alarm log

Config

Option

Start ventilation mode hard key

Standby (switch to standby, stop ventilation) hard key Mute Alarm hard key for 2 or 10 minutes (10 min. only in MAN./SPONT.) Table 3: Symbol/Hard key

Symbol/LEDs

Description LED mains voltage present (lights green) LED battery operation (lights yellow) LED visual alarm display (lights red) Table 4: Symbol/LEDs

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Chapter 2: Safety and Warning Notices

Symbol/Screen (display only)

Description Remaining battery time screen icon Battery charging monitor screen icon Battery defect screen icon No Battery screen icon Mains voltage present screen icon Mains voltage not present screen icon Upper and lower alarm limits screen icon/control element

/

Central gas supply pressures screen icon

/

Screen icon gas cylinder pressures (10 l instead of central gas supply) Table 5: Symbol/Screen (display only)

Symbol/Screen (control element)

Description Real-time graph screen icon/control element ⇒ Zero shift ⇒ Zoom in Y direction ⇒ Autoscale ON/OFF Screen icon/control element number of real time charts. Screen icon/control element x−axis scaling Screen icon/control element selection of the measured value for realtime chart Full screen loop window display screen icon/control element Screen icon/control element Tresholds (alarm-limits) setting up Screen icon/control element monitoring value selection. Table 6: Symbol/Screen (control elements)

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Chapter 2: Safety and Warning Notices

Symbol/Buttons

Description Zoom loop in X direction button Shift Zero in X direction button Zoom loop in Y direction button Shift Zero in Y direction button Autoscale loops ON button Autoscale loops OFF button Close window button Scroll list button Scroll list (fast) buttom Automatically adjust alarms button Open log button Table 7: Symbol/Buttons

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Chapter 2: Safety and Warning Notices

Symbol/Screen (tabs)

Description Standby

during ventilation

Standby screen (active -> dark blue)

Real-time charts (active -> dark blue)

Trend charts window

Trend tabular window

Event Log

Alarm Log

Config

Option

Monitoring page 1 o. 2 Table 8: Symbol/Screen (tabs)

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Chapter 2: Safety and Warning Notices

2.7

Terms and abbreviations

Term, abbreviation

Description

Agent

Volatile anesthetic

AGS

Anesthetic Gas Scavenging System

AGS

Anesthetic gas spirator

Air

Medical compressed air

APL valve

Adjustable Pressure Limitation

ATP

Ambient Temperature, Pressure, Current measurement conditions outside the body

C20/C

Dynamic compliance during the last 20% of the inspiratory phase in relation to overall dynamic compliance (measurement fort he lungs’ overexpansion ≤1)

Calibration

During calibration, a gauge is checked and the deviation determined against a standard that is knows to be correct

Carrier gas

Gas used as fresh gas in conjunction with O2. General Air or N2O

Central gas supply

Central gas supply for O2, N2O, and Air

CO2

Carbon dioxide

Compliance

Expandability of the lungs

Des.

Desflurane, volatile anesthetic

Enf.

Enflurane, volatile anesthetic

Freq.

Number of breaths per minute

Fresh gas flow

Total flow of O2 and carrier gas into the anesthesia system

Hal.

Halothane, volatile anesthetic

HIS

Hospital Information System

HLM

Heart-lung-machine

I:E

Ratio of Inspiration to Expiration time

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Chapter 2: Safety and Warning Notices

Term, abbreviation

Description

IMV

Intermittent Mandatory Ventilation Volume-controlled ventilation

Insp. Flow

Inspiration flow

Insp. Vol

Inspiration volume

Iso.

Isoflurane, volatile anesthetic

Leak

Difference between inspiratory and expiratory tidal volume (loss of gas in respiratory tubes, at seals, transition points, and at tube)

Loop

Plots of measured flow against pressure, volume against pressure, or flow against volume in a coordinate system

Low Flow

Fresh gas flow ≤ 1000 ml

MAC

Minimum Alveolar Concentration

Minimal flow

Fresh gas flow ≤ 500 ml

MV

Minute volume

N2O

Nitrous oxide

O2

Oxygen

O2 flush

Oxygen flush

Patient Category Adult

Quick selection of preconfigured ventilation parameter settings and alarm limits for ventilating adults

Patient Category Child

Quick selection of preconfigured ventilation parameter settings and alarm limits for ventilating adults

Paw

Pressure in the airway

PCV

Pressure Controlled Ventilation

PDMS

Patient Documentation System

PEEP

Positive End Expiratory Pressure

PInsp

Target pressure for PCV

Plateau

Percentage plateau length during inspiration

PMean

Mean pressure in the airway

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Chapter 2: Safety and Warning Notices

Term, abbreviation

Description

PPeak

Maximum pressure in the airway

PPlateau

Plateau pressure in the airway

PSV

Pressure Support Ventilation

# of Charts

Number of real-time charts (at least 1, maximum 4)

Ratio System

With N2O as carrier gas, the minimal concentration setting for O2 = 25%.

Resistance

Airway resistance

S−IMV

Synchronized Intermittent Mandatory Ventilation

S−PCV

Synchronized Pressure Controlled Ventilation

Settings

Settings

Sev.

Sevoflurane, volatile anesthetic

Trig. Flow

Flow required to set off trigger

Trig. Vol.

Volume required to set off trigger

Trigger

Ability to synchronize the ventilator with patient's spontaneous breathing

Units of pressure

⇒ 100 kPa (kilopascal) = 1 bar = approx. 1 atm ⇒ 1 atm = approx. 1 kg/cm2 (kp/cm2) ⇒ 1 hPa = 100 Pa ⇒ 1 kPa ⇒ 1 bar

= approx. 10 cmH2O = 1 kPa x 100

⇒ 1 mbar ⇒ 1 mmHg

= approx. 1 cmH2O

Units of pressure (norm)

⇒ 1 kPa ⇒ 1 Pa 100

= 1 bar

UPS

Uninterrupted Power Supply

Vapor

Anesthetic vaporizer

VT

Tidal volume

VTe

Expiratory tidal volume

VTi

Inspiratory tidal volume

2-16

= approx. 133 Pa

= 1 mbar

= approx. 1 cmH2O

Heinen + Löwenstein®, Service Manual leon/leonplus Rev. 2.1.1

Chapter 3: Pneumatic/mechanical modules

3

Pneumatic/mechanical modules

Contents Page 3.1 3.2 3.3 3.3.1 3.3.1.1 3.3.1.2 3.3.1.3 3.3.2 3.3.2.1 3.3.2.2 3.3.2.3 3.3.2.4 3.3.2.5 3.3.2.6 3.3.2.7 3.3.3 3.3.4 3.3.4.1

Gas box/Insert Rev001/002 leonplus........................................................... 3-3 Gas box/Insert Rev003 leonplus.................................................................. 3-4 Gas box/Insert Rev001 leon ........................................................................ 3-5 Connector block (leon/leonplus).............................................................. 3-6 Functional description of the connector block leon/leonplus ............... 3-7 Connector block V2 leonplus (schematics) ......................................... 3-8 Connector block V3 leon/leonplus (schematics) ................................. 3-9 Switch block (leonplus only) .................................................................. 3-10 Switch block V1 ................................................................................ 3-10 Switch block V2 ................................................................................ 3-11 Switch block V3 ................................................................................ 3-12 Functional description of the switch block ......................................... 3-13 Switch block V1 (schematics) ........................................................... 3-14 Switch block V2 (schematics) ........................................................... 3-15 Switch block V3 (schematics) ........................................................... 3-16 High pressure connection CGS (leon/leonplus)..................................... 3-17 Actors Connector Board (pressure sensors).......................................... 3-18 Functional description of the pressure sensors................................. 3-19

3.4 3.4.1

Drive gas generator (leon/leonplus)........................................................... 3-20 Drive gas generator (schematics).......................................................... 3-21

3.5 3.5.1

Fresh gas blender (leonplus only).............................................................. 3-22 Fresh gas blender (schematics) ............................................................ 3-23

3.6 3.6.1

Rotameter block (leon only) ....................................................................... 3-24 Rotameter block (schematics) ............................................................... 3-25

3.7 3.7.1 3.7.2 3.7.3 3.7.4 3.7.5

Docking station and swivel arm ................................................................. 3-26 Docking station ..................................................................................... 3-27 Patient module (closed loop system)..................................................... 3-29 Plateau valve ........................................................................................ 3-30 Docking................................................................................................. 3-31 Docking station (schematics) ................................................................ 3-32

3.8 3.9 3.10 3.11

Characteristic curves for the pressure reducer........................................... 3-33 Mechanical pressure limit .......................................................................... 3-34 Overall view of the pneumatics (leon) ........................................................ 3-36 Overall view of the pneumatics (leonplus) ................................................. 3-37

Figures Page Figure 1: Gas box/Insert leonplus Rev001/002................................................................. 3-3 Figure 2: Gas box/Insert leonplusRev003 ........................................................................ 3-4 Figure 3: Gas box /Insert leon Rev001 ............................................................................. 3-5 Figure 4: Connector block ................................................................................................ 3-6 Figure 5: Connector block V2 leonplus (schematics)........................................................ 3-8 Figure 6: Connector block V3 leon/leonplus (schematics) ................................................ 3-9 Figure 7: Nitrous switch block V1 ................................................................................... 3-10 Heinen + Löwenstein®, Service Manual leonplus / leon Rev. 2.1.1

3-1

Chapter 3: Pneumatic/mechanical modules

Figure 8: Nitrous switch block V2 ................................................................................... 3-11 Figure 9: Nitrous switch block V3 ................................................................................... 3-12 Figure 10: Nitrous switch block V1 (schematics) ............................................................ 3-14 Figure 11: Nitrous switch block V2 (schematics) ............................................................ 3-15 Figure 12: Nitrous switch block V3 (schematics) ............................................................ 3-16 Figure 13: High pressure connection CGS (leon/leonplus)............................................ 3-17 Figure 14: Actors Connector Board (pressure sensors).................................................. 3-18 Figure 15: Valve block for the drive gas generator (leon/leonplus) ................................. 3-20 Figure 16: Drive gas generator (schematics).................................................................. 3-21 Figure 17: Valve block for the fresh gas generator (leonplus only) ................................. 3-22 Figure 18: Fresh gas blender (schematics) .................................................................... 3-23 Figure 19: Rotameter block (leon only)........................................................................... 3-24 Figure 20: Rotameter block (schematics) ....................................................................... 3-25 Figure 21: Docking station with patient module .............................................................. 3-26 Figure 22: Docking station.............................................................................................. 3-27 Figure 23: Docking station (tubing system) .................................................................... 3-28 Figure 24: Patient module .............................................................................................. 3-29 Figure 25: Plateau valve ................................................................................................ 3-30 Figure 26: Docking ......................................................................................................... 3-31 Figure 27: Docking station (schematics)......................................................................... 3-32 Figure 28: Functional/Operating principle of the plateau valve: ...................................... 3-34 Figure 29: Functional/Operating principle of the plateau valve ....................................... 3-35 Figure 30: Overall view of the pneumatics (leon)............................................................ 3-36 Figure 31: Overall view of the pneumatics (leonplus) ..................................................... 3-37

Tables Page Table 1: Drive gas generator flow rates.......................................................................... 3-20 Table 2: Fresh gas blender flow rates ............................................................................ 3-22

3-2

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Chapter 3: Pneumatic/mechanical modules

3.1

Gas box/Insert Rev001/002 leonplus The gas box contains all the modules of the leonplus that connect and distribute the supply gases.

Rev001: Gas box for devices with the gas types O2/AIR Rev001: Gasbox for devices with the gas types O2/AIR/N2O (Nitrous oxide option)

leonplus

Item no. 0209220 Connector block

High pressure connections

Vacuum On/Off Flush

switch block

Additional components For nitrous oxide option (only Rev002) Vacuum Adjustment

VAC HP O2 manometer

HP(N2O) manometer

Figure 1: Gas box/Insert leonplus Rev001/002

Heinen + Löwenstein®, Service Manual leonplus / leon Rev. 2.1.1

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Chapter 3: Pneumatic/mechanical modules

3.2

Gas box/Insert Rev003 leonplus The gas box contains all the modules of the leonplus that connect and distribute the supply gases.

Rev003: Gas box for devices with the gas types O2/AIR/N2O (Nitrous oxide option) as Rev001, but with external pressure reducer.

leonplus

Item no. 0209220 Connector block

High pressure connections

Vacuum On/Off Flush

Switch block

Vacuum Adjustment

VAC HP O2 manometer

HP (N2O) manometer

Figure 2: Gas box/Insert leonplusRev003

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Chapter 3: Pneumatic/mechanical modules

3.3

Gas box/Insert Rev001 leon The gas box of the leon contains no switch block.

leon

Art.-Nr: 0209215 Connector block

High pressure connections

Vacuum On/Off Flush

Vacuum Adjustment

VAC HP O2 manometer

HP (N2O) manometer

Figure 3: Gas box /Insert leon Rev001

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Chapter 3: Pneumatic/mechanical modules

3.3.1

Connector block (leon/leonplus) The connector block contains the pressure regulators for the control pressure of the slide valves inside the patient module. The upper pressure regulator controls the control pressure (measured at TP1) for switchover to "Open System (OS slide valve) and between "automatic/manual" (AM1 and AM2 slide valve). Gas box

Item no. 0209500

The lower pressure regulator controls the control pressure (measured at TP2 for the excess diaphragm (HM). Both test points (TP1, TP2) are equipped with protection caps that can be removed to set or measure the pressures. Central gas supply inlet:

Drive gas outlet Magnetic Valve A

Magnetic Valve D

Magnetic Valve B

O2

N2O

AIR

Pressure regulator 1.2 bar switchoverAM1/AM2/OS switching Pressure regulator 125 mbar Excess diaphragm (HM) Magnetic Valve C Figure 4: Connector block

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Chapter 3: Pneumatic/mechanical modules

3.3.1.1

Functional description of the connector block leon/leonplus

Magnetic Valve A:

Switches the control pressure for the "automatic/manual" slide valve (AM1, AM2) inside the patient module.

Magnetic Valve B:

Switches the control pressure for the "open system" (OS) slide valve inside the patient module.

Magnetic Valve C:

Switches the control pressure for the excess diaphragm (HM) inside the patient module.

Magnetic Valve D:

Enables the selection of drive gas (O2/AIR). The downstream pneumatic valve ensures that if the O2 supply fails, the system will automatically switch over to AIR as the drive gas.

Pilot pressure 1.2 bar:

The control pressure for the slide valves inside the patient module must equal 1 hPa*100 (bar) to ensure that the valves will switch securely. The setting adjustment is found on the upper pressure regulator of the connector block. The pressure is measured at test point 1 (TP1). Remove the protection cap prior to measurement.

Pilot pressure 125 cmH2O: The control pressure for the excess diaphragm must equal 125 hPa (cmH2O) to ensure a sufficiently fast reaction time. The setting adjustment is found on the lower pressure regulator of the connector block. The pressure is measured at test point 2 (TP2). Remove the protection cap prior to measurement.

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Chapter 3: Pneumatic/mechanical modules

3.3.1.2

Connector block V2 leonplus (schematics)

Figure 5: Connector block V2 leonplus (schematics)

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Chapter 3: Pneumatic/mechanical modules

3.3.1.3

Connector block V3 leon/leonplus (schematics)

Figure 6: Connector block V3 leon/leonplus (schematics)

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Chapter 3: Pneumatic/mechanical modules

3.3.2

Switch block (leonplus only)

3.3.2.1

Switch block V1 The switch block V1 is only used in units without nitrous oxide. For changing a unit in order to use nitrous oxide it is necessary to update the switch block to V2/V3.

Gas box

Item no. 0209550

Inlets: AIR / N2O / O2

Pneumatic ventil Magnetic valve E (Switchover carrier gas)

Magnetic valve F (Emergency dosing)

Outlet carrier gas N2O/AIR

Outlet Emergency dosing

Pressure regulator AIR

Pressure regulator O2

Outlet O2 Flush

Outlet O2

Figure 7: Switch block V1

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Chapter 3: Pneumatic/mechanical modules

3.3.2.2

Switch block V2 The switch block enables the selection of the carrier gas (N2O/AIR). The pneumatic valve downstream from magnetic valve E ensures that if the O2 supply fails, the carrier gas will switch from N2O to AIR. Gas box

This ensures that the patient is not ventilated with pure N2O should the electronics or the software fail. There is a separate pressure regulator for each type of gas.

Art.-Nr: 0209550

Inlet: N2O / O2

Magnetic valve E (Switchover carrier gas)

unused

Magnetic valve F (Emergency dosing)

Outlet carrier gas N2O/AIR Pressure regulator N2O

Outlet Emergency dosing Outlet O2 Flush

Outlet O2 Pressure regulator O2 Inlet AIR

Pressure regulator AIR

Figure 8: Switch block V2

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Chapter 3: Pneumatic/mechanical modules

3.3.2.3

Switch block V3 The switch block enables the selection of the carrier gas (N2O/AIR). The pneumatic valve downstream from magnetic valve E ensures that if the O2 supply fails, the carrier gas will switch from N2O to AIR. Gas box

This ensures that the patient is not ventilated with pure N2O should the electronics or the software fail. For AIR and N2O there is one common pressure regulator.

Item no. 0209550 Pneumatic Valve N2O) (Notdosierung) Inlet:

Pneumatic Valve (AIR) (Notdosierung)

Pressure regulator carrier gas Magnetic Valve F (Emergency dosing)

Pressure regulator O2

N2O

O2

AIR

Magnetic Valve E (Switchover drive gas)

Outlet carrier gas N2O/AIR

Outlet emergency dosing Outlet O2 Flush

Outlet O2

Figure 9: Switch block V3

3-12

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3.3.2.4

Functional description of the switch block

Magnetic valve E:

Switches the carrier gas from AIR to N2O via the downstream pneumatic valve. If the O2 supply fails, the pneumatic valve drops.

Magnetic valve F:

Switches the emergency dosing/dosage. The valve enables the use of emergency dosing if there is no current, i.e. if the device fails or it is turned off.

Blender inlet pressure:

To ensure the fresh gas blender functions properly, both supply pressures (carrier gas and oxygen) must be adjusted exactly. (See chapter Calibration)

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3-13

Chapter 3: Pneumatic/mechanical modules

3.3.2.5

Switch block V1 (schematics)

Figure 10: Switch block V1 (schematics)

3-14

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Chapter 3: Pneumatic/mechanical modules

3.3.2.6

Switch block V2 (schematics)

Figure 11: Switch block V2 (schematics)

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3-15

Chapter 3: Pneumatic/mechanical modules

3.3.2.7

Switch block V3 (schematics)

Figure 12: Switch block V3 (schematics)

3-16

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Chapter 3: Pneumatic/mechanical modules

3.3.3

High pressure connection CGS (leon/leonplus) The high pressure connections are used to connect the reserve gas bottles. The leon/leonplus is available with a number of variants. Pin Index connections or screw connections (DIN) are available. Gas box module

Pin Index: Item no. 0341005 (O2) Item no. 0341015 (N2O)

DIN: Item no. 0341005 (O2) Item no. 0341010 (N2O)

PIN-Index

DIN

Figure 13: High pressure connection CGS (leon/leonplus)

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Chapter 3: Pneumatic/mechanical modules

3.3.4

Actors Connector Board (pressure sensors) The Actors Connector Board is installed at the side of the connector block. The pressure sensors monitor the supply pressures of the gas supply and project into the manometer ports of the connector block.

Gas box module

Art.-Nr: 0208950

PS3

PS2

PS4

PS5

PS1

Figure 14: Actors Connector Board (pressure sensors)

3-18

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Chapter 3: Pneumatic/mechanical modules

3.3.4.1

Functional description of the pressure sensors

The views of the connector block diagram (pages 3-8 and 3-9) again illustrate the positioning of the pressure sensors in the pneumatic system.

Pressure sensor PS1:

Monitors the supply pressure/status of the AIR supply of the central gas supply (CGS).

Pressure sensor PS2:

Monitors the supply pressure/status of the O2 supply of the central gas supply (CGS).

Pressure sensor PS3:

Monitors the status of the O2 supply. If the pressure level at PS2 is lower than at PS3, the leon/leonplus assumes that O2 is being supplied from the connected gas bottle/cylinder (NOTE: used previously).

Pressure sensor PS4:

Monitors the supply pressure/status of the N2O supply of the central gas supply (CGS).

Pressure sensor PS5:

Monitors the status of the N2O supply. If the pressure level at PS4 is lower than at PS5, the leon/leonplus assumes that N2O is being supplied from the connected gas bottle/cylinder.

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Chapter 3: Pneumatic/mechanical modules

3.4

Drive gas generator (leon/leonplus) The drive gas generator produces the drive gas for the bellows. A valve bench with 12 valves generates the required flow volume. Since the flow rate of each valve greatly depends on the supply pressure of the generator, the supply pressure is measured and taken into account in the control of the valves. In this way, the drive gas generation compensates for fluctuations in supply pressures. Rear view leonplus

Item no. 0208750-1 CAUTION! The values indicated are valid for a supply pressure of 4 hPa*100 (bar). The actual values depend on the inlet pressure.

Valve 5 4 3 2 8 9 10 11 12 6, 7, 13

Flow rate 0.07 l/m 0.15 l/m 0.3 l/m 0.6 l/m 1.25 l/m 2.5 l/m 5 l/m 10 l/m 20 l/m 40.0 l/m Table 1: Drive gas generator flow rates

O2/AIR inlet

Drive gas outlet Figure 15: Valve block for the drive gas generator (leon/leonplus)

3-20

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Chapter 3: Pneumatic/mechanical modules

3.4.1

Drive gas generator (schematics)

Figure 16: Drive gas generator (schematics)

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Chapter 3: Pneumatic/mechanical modules

3.5

Fresh gas blender (leonplus only) The fresh gas blender produces the anesthetic/gas mixture using an electronic blender consisting of 2 valve benches, each with 9 vents for N2O/AIR and O2. Each of these vents allows a defined amount of the respective gas to flow through to the fresh gas outlet. Additional control of the valves allows the gases to be mixed in all the required ratios. The range of the valve benches is 0-18 l/m.

Rear view leonplus

Item no. 0208751-1 CAUTION! For the blender to operate smoothly, a fixed supply pressure is required.

Valve (O2) 10 11 12 13 14 15 0 1 2

N2O/AIR valve 16 17 18 19 20 21 22 23 8

Flow rate 0.035 l/m 0.07 l/m 0.14 l/m 0.28 l/m 0.56 l/m 1.12 l/m 2.25 l/m 4.5 l/m 9.0 l/m

Table 2: Fresh gas blender flow rates

Fresh gas outlet

O2 inlet Carrier gas inlet N2O/AIR Figure 17: Valve block for the fresh gas blender (leonplus only)

3-22

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Chapter 3: Pneumatic/mechanical modules

3.5.1

Fresh gas blender (schematics)

Figure 18: Fresh gas blender (schematics)

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Chapter 3: Pneumatic/mechanical modules

3.6

Rotameter block (leon only) Unlike the leonplus the leon comes with a rotameter block instead of the electronics fresh gas blender.

Rear view leon

item no: 0208800

Device with 3 gases (AIR, O2, N2O)

item no: 0208800-1 Device with 2 gases (AIR, O2)

Fresh gas outlet

AIR inlet N2O inlet O2 inlet

Figure 19: Rotameter block (leon only)

3-24

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Chapter 3: Pneumatic/mechanical modules

3.6.1

Rotameter block (schematics)

Figure 20: Rotameter block (schematics)

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Chapter 3: Pneumatic/mechanical modules

3.7

Docking station and swivel arm The docking station provides a seating for the patient module, and, assisted by the swivel arm, it establishes the electrical and pneumatic connections between the patient module and the rest of the device. The O-rings in the docking station and at the connection to the plateau valve are subject to increased wear and tear due to the movement of the swivel arm and should be replaced each year during annual maintenance. The patient module contains the complete closed loop system and is placed onto the docking station from above, or removed from the docking station by lifting it.

leon/leonplus

Exp. Insp. AGS DOME (bellow)

BAG

Absorber

Figure 21: Docking station with patient module

3-26

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Chapter 3: Pneumatic/mechanical modules

3.7.1

Docking station

The docking station establishes all connections to the patient module, except for the plateau valve (Voice Coil 1).

Docking station

Fresh Gas (FG) Pressure measurement (Paw) Excess Diaphragm (HM)

Fresh Gas (FG)

Switch over open

Voice Coil 2 PEEP

Switch over Auto/Manual Heating Flow sensors connectors Excess diaphragm (HM) Pressure measurement (Paw) sample gas return

Figure 22: Docking station

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Chapter 3: Pneumatic/mechanical modules

Crimped or bent tubes Device malfunction CAUTION

ƒ

When attaching the cover, make sure that none of the tubes is crimped or bent.

Tubing: Figure 23 illustrates how to thread the tubing through the docking station. When attaching the cover, make sure that none of the tubes is crimped or bent.

Docking station

Crimped or bent tubes are not always immediately obvious! A crimped tube may not give way until some time has passed and only then become completely blocked.

Pressure measurement (Paw)

Fresh Gas (FG)

Excess diaphragm (HM)

Figure 23: Docking station (tubing system)

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Chapter 3: Pneumatic/mechanical modules

3.7.2

Patient module (closed loop system)

The leon/leonplus is a closed anesthesia system. CO2 is removed from the expiratory respiratory gas using the absorber inside the closed loop system. The "missing" volume is replaced by the anesthetic gas mixture produced by the fresh gas blender and the anesthetic vaporizer. The patient module contains the full closed loop system!

Docking station with patient module

Tube connection expiration

Tube connection Inspiration

Absorber connection

Bellows connection

Figure 24: Patient module

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Chapter 3: Pneumatic/mechanical modules

3.7.3

Plateau valve The plateau valve (Voice Coil 1) releases drive gas from the bellows during the expiration phase. The closed plateau valve establishes the connection between the drive gas generator and the bellows (chamber, outside surface). The movability of rotating support maintenance. The to the increased docking station.

Docking station

the block in the dovetail guide of the should be checked during annual O-ring should be replaced annually due mechanical wear and tear from the

Drive Gas Inlet Swivel arm

To bellows

Plateau valve block Drive Gas Outlet

O ring

Figure 25: Plateau valve

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Chapter 3: Pneumatic/mechanical modules

3.7.4

Docking

No.

Function

1

Plateau valve

2

Open switch over

3

Auto/Man. switch over

While the plateau valve (1) is in direct contact with the patient module, all other pneumatic connections are made via the docking station.

4

Fresh gas (FG)

5

Airway pressure (Paw)

6

Excess diaphragm (HM)

The HP (high pressure) port provides the control pressures for the "auto/manual" switch over (3) and the "open system" (2) switch over. The LP port delivers the fresh gas (4) and the control pressure for the excess diaphragm (6). Additionally, the airway pressure (5) is guided to the pressure sensors inside the device. All O-rings between the ports and the docking station, and between the plateau valve and the patient module are subject to increased mechanical wear and tear from the movement of the docking station and are partly involved in oxygen and anesthetic gas mixing. They should therefore be replaced each year during annual maintenance.

1

Plateau valve

LP Port

HP Port

4

6

2

3

5

Figure 26: Docking

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3.7.5

Docking station (schematics)

Figure 27: Docking station (schematics)

3-32

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Chapter 3: Pneumatic/mechanical modules

3.8

Characteristic curves for the pressure reducer

The pressure reducer for the control pressures and the inlet pressures of the fresh gas blender are set at the factory at a central gas supply pressure of 5 hPa *100 (bar). If one of the pressure reducers is replaced, adjust the setting according to the supply pressure of manufacturer's characteristic curve: RM1H-NNG-KCN-010 (pressure reducer 1 bar) RM1H-NNG-KCN-010 (pressure reducer 100 bar)

Flow properties

Outlet pressure (psi)

Inlet pressure range: From: 2.8 hPa *100 (bar) 40.6 psi To: 6.0 hPa *100 (bar) 87.0 psi Outlet pressures: 1 hPa *100 (bar) 14.5 psi 0.1 hPa *100 (bar) 1.45 psi Flow (l/min)

Control Properties at 50 l/min

Outlet pressure (psi)

Outlet pressure (psi)

at 100 l/min

Inlet pressure (psi)

Inlet pressure (psi)

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Chapter 3: Pneumatic/mechanical modules

3.9

Mechanical pressure limit

The mechanical pressure limit in the patient tube system is ensured by the plateau valve (Voice Coil 1) and the PEEP valve (Voice Coil 2). Functional/Operating principle of the plateau valve:

Drive Gas Inlet

Dom (bellows) Permanent magnet

Drive Gas Outlet

Electro magnet/Coil

Figure 28: Functional/Operating principle of the plateau valve:

When quiescent/In idle state (w/o control), the plateau valve is open. Depending on the design, an inspiratory airway pressure no higher than 12.5 kPa (125 cmH2O) can be generated in the controlled state. Therefore, the plateau valve does not only control the flow of drive gas, but also mechanically limits the inspiratory airway pressure at the same time.

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Chapter 3: Pneumatic/mechanical modules

Functional/Operating principle of the PEEP valve:

Expiration

Permanent magnet

Diaphragm

Electro magnet/Coil

Figure 29: Functional/Operating principle of the plateau valve

When quiescent/In idle state (w/o control), the PEEP valve is open. Depending on the type of construction, an expiratory airway pressure no higher than 12.5 kPa (125 cmH2O) can be generated in the controlled state. Therefore, the PEEP valve does not only control the endexpiratory airway pressure, but at the same time ensures the mechanical limit of the maximum possible airway pressure.

Check valves inside the closed loop system (patient module):

All check valves in the closed loop system comply with the specifications of DIN EN 740.

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Chapter 3: Pneumatic/mechanical modules

3.10

Overall view of the pneumatics (leon)

Figure 30: Overall view of the pneumatics (leon)

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Chapter 3: Pneumatic/mechanical modules

3.11

Overall view of the pneumatics (leonplus)

Figure 31: Overall view of the pneumatics (leonplus)

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Chapter 4: Electronic modules

4

Electronic modules

Contents Page 4.1 4.1.1

Mains connection board............................................................................... 4-3 Mains connection board (diagram) .......................................................... 4-4

4.2 4.2.1

AC/DC converter ......................................................................................... 4-5 AC/DC converter (diagram)..................................................................... 4-6

4.3 4.3.1

Actors Connector Board (electronics) .......................................................... 4-7 Actors Connector Board (diagram).......................................................... 4-8

4.4 4.4.1

Main board .................................................................................................. 4-9 Main board (diagram)............................................................................ 4-10

4.5 4.5.1

Flow board................................................................................................. 4-11 Flow board (diagram) ............................................................................ 4-12

4.6 4.7 4.8 4.9 4.9.1 4.9.2 4.9.3

Drive gas generator board ......................................................................... 4-13 Fresh gas blender board............................................................................ 4-14 Blender board Rev. 3.0.1........................................................................... 4-15 Measurement Systems .............................................................................. 4-16 Measurement accuracy of the pressure sensors ................................... 4-16 Measurement ranges and resolutions ................................................... 4-17 Electronic limitation of the airway pressure: .......................................... 4-18

4.10 4.11

Overall electronic layout (leon) .................................................................. 4-19 Overall electronic layout (leonplus)............................................................ 4-20

Figures Page Figure 1: Mains connection board .................................................................................... 4-3 Figure 2: Mains connection board (diagram) .................................................................... 4-4 Figure 3: AC/DC converter ............................................................................................... 4-5 Figure 4: AC/DC converter (diagram) ............................................................................... 4-6 Figure 5: Actors Connector Board (electronics)................................................................ 4-7 Figure 6: Actors Connector Board (diagram) .................................................................... 4-8 Figure 7: Main board ........................................................................................................ 4-9 Figure 8: Main board (diagram) ...................................................................................... 4-10 Figure 9: Flow board ...................................................................................................... 4-11 Figure 10: Flow board (diagram) .................................................................................... 4-12 Figure 11: Drive gas generator board............................................................................. 4-13 Figure 12: Fresh gas blender board ............................................................................... 4-14 Figure 13: Blender board leonplus (Rev: 3.0.1) .............................................................. 4-15 Figure 14: Overall electronic layout (leon) ...................................................................... 4-19 Figure 15: Overall electronic layout (leonplus) ............................................................... 4-20

Tables Page - none 4-2

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Chapter 4: Electronic modules

4.1

Mains connection board The mains connector board distributes the incoming power supply to 4 auxiliary outlets, fused on both wires, and supplies the AC/DC converter of the leon/leonplus simultaneously via an input filter. Both inlet fuses (2x2AT) secure/protect the electronics of the leon/leonplus directly. All others secure/protect the auxiliary outlets. Rear view

As the safety fuses age during the device's operation, they must be replaced during general maintenance (every 3 years or every 10,000 hours of operation).

Item no.: 0208935

Inlet fuses

Figure 1: Mains connection board

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Chapter 4: Electronic modules

4.1.1

Mains connection board (diagram)

Figure 2: Mains connection board (diagram)

4-4

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Chapter 4: Electronic modules

4.2

AC/DC converter Switch/Transposition of the power lines of the AC/DC converter Device cannot be turned on ƒ

ACHTUNG

Make sure not to switch/transpose the power lines

The AC/DC converter is installed on the hinged rear wall. The Master Module supplies the leon/leonplus control directly via the Adapter Board. The Slave Module supplies the patient module heater via the Actors Connector Board. It is triggered by the Slave Module's inhibit input. If the connectors are switched during the converter's installation, the device does not function/the device is not ready for use. If it can be switched on, it will cut its own power supply during shut down.

Rear view

The switch/transposition of the power lines might not be noticed immediately. It is possible that the leon/leonplus only reacts to the change after shut down and cannot be turned on again.

Item no.: 0209605

X1

Master Module

X2 X3 X4 X5 X6

Slave Module X7 Figure 3: AC/DC converter

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Chapter 4: Electronic modules

4.2.1

AC/DC converter (diagram)

Figure 4: AC/DC converter (diagram)

4-6

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Chapter 4: Electronic modules

4.3

Actors Connector Board (electronics) The Actors Connector Board is the central switchboard for almost all of the connections between the control electronics and the pneumatics electronic components. Together with the pressure sensors, it is the interface between the electronic and pneumatic subsystems. Gas Box

Item no.: 0208950 PS3

PS2

PS4

PS5

PS1

Figure 5: Actors Connector Board (electronics)

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Chapter 4: Electronic modules

4.3.1

Actors Connector Board (diagram)

Figure 6: Actors Connector Board (diagram)

4-8

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Chapter 4: Electronic modules

4.4

Main board The Main board is the control center of the leon/leonplus. Two PIC processors control and monitor it. Both communicate through different routes/transmission paths with the user interface.

Rear view

While the Conductor PIC executes the incoming commands, the Monitor PIC monitors the measurements. Both processors receive the data sent by the user interface and return them in 8s cycles. If both values from the PICs deviate, the user interface recognizes this and informs the user with an alarm accordingly.

Item no.: 0208710

The pressure sensor (PS8) monitors the airway pressure. Pressure sensor type: XPC01GFSH

Conductor PIC Monitor PIC

Backup battery Pressure sensor PS8 Figure 7: Main board

Heinen + Löwenstein®, Service Manual leonplus / leon Rev. 2.1.2

4-9

Chapter 4: Electronic modules

4.4.1

Main board (diagram)

Figure 8: Main board (diagram)

4-10

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Chapter 4: Electronic modules

4.5

Flow board The Flow Board contains the electronics for both flow sensors. The sensors work according to the hot-wire principle. The hot-wire is located in the gas flow/stream and is kept at a constant temperature by the electronics.

Rear view

The gas flow/stream extracts energy from the wire. Thus, more energy is necessary to maintain the temperature. Thus, the change of the electrical power in the hot-wire is directly related to the gas flow rate in the sensor.

Item no.: 0208900

Figure 9: Flow board

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Chapter 4: Electronic modules

4.5.1

Flow board (diagram)

Figure 10: Flow board (diagram)

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Chapter 4: Electronic modules

4.6

Drive gas generator board The Drive gas generator board contains the driver levels / stages for triggering the magnet valves. The pressure sensor (PS7) monitors the airway pressure (Paw). Sensor S3 monitors the driver gas generator inlet pressure.

Blender boards

Different inlet pressures have significant influence on the flow rates of each valve. Thus, the inlet pressure is measured and included in triggering the valves. Pressure sensor type PS7: XPC01GTC Pressure sensor type S3: XPC100XPC

Item no.: 0208750-2

Pressure sensor (PS7) Airway pressure (Paw)

Pressure sensor (S3) Inlet pressure drive gas generator

Figure 11: Drive gas generator board

The drive gas generator board was replaced by the blender board, rev. 3.0.1 (chapter 4.8). This combines the drive gas and fresh gas generator board.

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Chapter 4: Electronic modules

4.7

Fresh gas blender board The Fresh gas blender board contains the driver levels / stages for triggering the magnet valves. The pressure difference sensor (S2) monitors the gas flow at the fresh gas blender outlet.

Blender boards

In addition, the oxygen content of the mixture is monitored by an internal O2 measurement cell. As this is a fuel cell, it has to be replaced during annual maintenance. Pressure sensor type S2: XPCL04DTC

Item no.: 0208751-2

Pressure difference sensor (S2) Fresh gas outlet

Figure 12: Fresh gas blender board

The fresh gas blender board was replaced by the blender board, rev. 3.0.1 (chapter 4.8). This combines the drive gas and fresh gas generator board. 4-14

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Chapter 4: Electronic modules

4.8

Blender board Rev. 3.0.1

The new Blender board (Revision 3.0.1) combines the fresh gas blender and drive gas generator board on one board. It fulfils the function of triggering the magnet valves of the drive gas generator and the fresh gas blender. Because leon is not equipped with a fresh gas blender, it uses a different Blender board containing only the function of triggering the magnet valves of the drive gas generator. Item no:

Blender board leon Blender board leonplus

0208750-2hul301 0208751-2hul301

Pressure difference sensor (S2) Fresh gas outlet

Pressure sensor (PS7) Airway pressure (Paw)

Pressure sensor (S3) Inlet pressure drive gas generator Figure 13: Blender board leonplus (Rev: 3.0.1)

Position of the pressure sensor Inlet pressure drive gas generator and airway pressure are interchanged to each other compared older to newer revision (Rev. 301) The pressure difference sensor (S2) monitors the gas flow at the fresh gas blender outlet. The pressure sensor (PS7) monitors the airway pressure (Paw). Sensor (S3) monitors the driver gas generator inlet pressure. Different inlet pressures have significant influence on the flow rates of each valve. Thus, the inlet pressure is measured and included in triggering the valves.

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Chapter 4: Electronic modules

4.9

4.9.1

Measurement Systems

Measurement accuracy of the pressure sensors

Pressure sensors for airway pressure and blender inlet pressure:

Manufacturer data sheet excerpt:

4-16

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Chapter 4: Electronic modules

Pressure sensors ACB (inlet pressures) Type: XFPM-001MPGR Pressure range Maximum pressure Accuracy/Tolerance Outlet (Offset) Outlet (Full span)

4.9.2

0 ∼ 1000 0 ∼ 1000 1500 15 ± 2.5 0.2 ± 0.1125 4.7 ± 0.1125

kPa bar kPa bar %FS (at 0 to 85ºC) V V

Measurement ranges and resolutions

Electronic measurement processing of the pressure sensors overview: Supply pressures: (Actors Connector Board: PS1 - PS5) Sensor PS1 PS2 PS3 PS4 PS5

Measurement range 0 to 1065 kPa (10.65 bar) 0 to 1065 kPa (10.65 bar) 0 to 1065 kPa (10.65 bar) 0 to 1065 kPa (10.65 bar) 0 to 1065 kPa (10.65 bar)

Display 10 kPa (0.1 bar) 10 kPa (0.1 bar) 10 kPa (0.1 bar) 10 kPa (0.1 bar) 10 kPa (0.1 bar)

Inlet drive gas pressure Pressure sensor Measurement range S3 - 104 to 1113 kPa (11.13 bar)

Measurement tolerance 1 kPa (0.01 bar) 1 kPa (0.01 bar) 1 kPa (0.01 bar) 1 kPa (0.01 bar) 1 kPa (0.01 bar)

Measurement tolerance 1 kPa (0.01 bar)

Airway pressure: (Drive gas generator board: PS7, Main board PS8) Measurement Sensor Measurement range Display tolerance PS7 - 52 to 1262 mmH2O cmH2O / 1 cmH2O 0.1 cmH2O PS8 -96 to 1157 mmH2O cmH2O / 1 cmH2O 0.1 cmH2O

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Chapter 4: Electronic modules

4.9.3

•

Electronic limitation of the airway pressure:

Pmax Adjustable maximum pressure! This pressure is not exceeded during the device's normal operation. Reaching Pmax the plateau is formed.

•

PPeak Adjustable upper pressure limit with alarm. When reaching PPeak, the device terminates the inspiration phase and discharges the patient tube system by opening the plateau valve and the peep valve.

4-18

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Chapter 4: Electronic modules

4.10

Overall electronic layout (leon)

Figure 14: Overall electronic layout (leon)

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Chapter 4: Electronic modules

4.11

Overall electronic layout (leonplus)

Figure 15: Overall electronic layout (leonplus)

4-20

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Chapter 5: Update Systemsoftware

5

Update Systemsoftware

Contents page 5.1 5.1.1 5.1.2

Software Update ............................................................................................5-3 Preliminary steps leon/leonplus................................................................5-4 Form to record the settings leon/leonplus .................................................5-7

5.2 5.3 5.3.1 5.3.2 5.3.2.1 5.3.2.2 5.3.3 5.3.4

Versions of software update...........................................................................5-8 Software update by Boot CD..........................................................................5-8 Required materials ....................................................................................5-8 Preparations ..............................................................................................5-8 Burning Boot-CD...................................................................................5-8 Procedure by existing Boot-CD.............................................................5-9 Update environment setup ......................................................................5-10 Starting Update........................................................................................5-10

5.4 5.4.1 5.4.2 5.4.2.1 5.4.3

Update by static IP address .........................................................................5-12 Required materials ..................................................................................5-12 Preparation ..............................................................................................5-12 Set up static IP address ......................................................................5-13 Update environment setup ......................................................................5-16

5.5 5.5.1 5.5.2 5.5.3

Start DEVICE_setup.exe..............................................................................5-17 Update with Kernel (Windows-CE platform) ............................................5-19 Update without Kernel .............................................................................5-20 Enforce a complete update......................................................................5-21

5.6 5.6.1 5.6.2 5.6.3 5.6.4

USB auto Update (in preparation)................................................................5-22 Required material ....................................................................................5-22 Procedure ................................................................................................5-22 Update environment ................................................................................5-22 Starting Update........................................................................................5-23

5.7 5.8 5.8.1 5.8.2

Read logfiles ................................................................................................5-24 Power Pic Update ........................................................................................5-25 Update environment setup (Power PIC)..................................................5-25 Power-Pic update ....................................................................................5-26

5.9

Change PICs (Monitor PIC, Conductor PIC)................................................5-28

Figures page Figure 1: Determining the existing software versions .........................................................5-4 Figure 2: Determining the flow correction factor .................................................................5-5 Figure 3: Determining device configuration ........................................................................5-5 Figure 4: Determining user configuration ............................................................................5-6 Figure 5: contents of the zip-folder .....................................................................................5-9 Figure 6: program Burn CD.................................................................................................5-9 Figure 7: Update environment setup.................................................................................5-10 Figure 8: network error......................................................................................................5-10 Figure 9: Starting update tool............................................................................................5-11 Figure 10: change to explorer ...........................................................................................5-11 Figure 12: Set up static IP address (Windows 2000/Windows XP)...................................5-14 Figure 13: Set up static IP address (Windows 7) ..............................................................5-15 Figure 14: Update environment setup...............................................................................5-16 Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.2

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Chapter 5: Update Systemsoftware

Figure 15: Starting DEVICE_setup.exe ............................................................................5-17 Figure 16: Update program in AutoMode..........................................................................5-17 Figure 17: Update exclusive Kernel ..................................................................................5-18 Figure 18: Setup Update with Kernel ................................................................................5-19 Figure 19: Setup Update without Kernel ...........................................................................5-20 Figure 20: Enforce an update ...........................................................................................5-21 Figure 21: „Wait for connection“ message .......................................................................5-21 Figure 22: USB-connector on controller board .................................................................5-22 Figure 23: Starting USB-Stick update ...............................................................................5-23 Figure 24: Update screen on the device ...........................................................................5-23 Figure 25: read logfiles .....................................................................................................5-24 Figure 26: Setup Update Power Pic..................................................................................5-25 Figure 27: Power PIC update (page 1) .............................................................................5-26 Figure 28: Power PIC update (page 2) .............................................................................5-27 Figure 29: Open rear panel to change PICs .....................................................................5-28 Figure 30: Main board and flow board ..............................................................................5-29 Figure 31: Conductor-PIC and Monitor-PIC on main board ..............................................5-29 Figure 32: Groove on Conductor-PIC and Monitor-PIC ....................................................5-30

Tables page - none -

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Chapter 5: Update Systemsoftware

5.1

Software Update

The software for the different hardware modules of the leon/leonplus is usually delivered as a package and requires no further customization. The installation is normally carried out according to the instructions; exceptions are documented separately. The printed screens show the software of the leonplus. The actual display on the unit can be different to the illustration in this service manual. Updating during operation Danger of injury to patient 

DANGER

Under no circumstances must a patient be connected to the device while the software update is being installed!

Electrostatic discharges in the device

Risk of damage to the device  CAUTION

  

All work on the device must be done on a suitable earthed and conductive work surface (antistatic, ESD protection). Make sure that you are sufficiently earthed (e.g. 1 MΩ). Earth every instrument used during work on the ventilator Transport components and printed-circuit boards in the correct antistatic packages only.

Interrupting the update procedure Risk of damage to the device 

CAUTION

 

Make sure that both the leon/leonplus and the PC or Notebook being used to perform the update are connected to the power network. An update must never be performed while any of the devices is in battery operation. The update procedure must never be interrupted or aborted because this could cause serious damage to the hardware. A software firewall installed on the PC or Notebook could under certain circumstances block the data exchange required for the update. If a firewall is installed on the PC or Notebook, configure it accordingly or deactivate it while performing the update. Consult your system administrator, if necessary.

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Chapter 5: Update Systemsoftware

5.1.1

Preliminary steps leon/leonplus

Determining the existing software versions: Go to the menu item "Service ►Service ►System Info":

Software versions of the system components

Figure 1: Determining the existing software versions

Write down all software versions of the individual components (Conductor PIC = Control PIC). Compare the software versions with the versions listed in the "Versionen.txt" file in the update directory of your PC. All system component versions different from those in the "Version.txt" must be updated. Use the attached form to collect the values.

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Chapter 5: Update Systemsoftware

Determining the system configuration: Go to the following menu item: "Service ►Flow Calibration”: (leonplus) Respectively: „Service ► Calibration ► Flow Calibration“: (leon)

Write down the correction factors of the flow measurement (insp. and exp.), in order to restore after the update.

Figure 2: Determining the flow correction factor

Go to the following menu item: "Service ►Configuration": Write down all values in the "Configuration" screen, in order to restore them after the update.

Figure 3: Determining device configuration

Use the attached form to collect the values.

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Chapter 5: Update Systemsoftware

Determining user settings: Switch to the ventilation screen:

5

4

3

1

2 Figure 4: Determining user configuration



The settings for the fresh gas blender (1), the ventilation mode including the ventilation parameters (2), and the limits (3) can be set for the categories "Child" and "Adult" and thus have to be written down separately.



The Monitoring (4) and Ventilation Graphs (5) settings are identical for the categories "Child" and "Adult" and thus only have to be written down once. Use the attached form to collect the values.

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Chapter 5: Update Systemsoftware

5.1.2

Form to record the settings leon/leonplus

System configuration Flow correction factor insp. Flow correction factor exp. Gas measurement PPeak alarm Gas supply Alarm for fresh gas short age Man./Spont.

Serial number leonplus (Standard: 1.000) (Standard: 1.000) External gas measurement: Internal O2 measurement: CO2 unit Def. Difference to insp. pressure Drive gas selection N2O supply O2 supply

Apnea time (s)

AION inactive mmHg

Other: active %

Air CGS CGS

O2 Cylinder Cylinder

active

inactive

none

(Standard 30s)

System component System (User interface) Kernel (CE Platform) Bootloader Firmware (CFB) Monitor PIC Conductor (Control) PIC Power PIC

Version (old)

Version (new)

Fresh gas settings Carrier gas O2 concentration Fresh gas flow

Child AIR

Adult AIR

Ventilation settings Ventilation mode

Child

N2O

N2O

Adult

IMV PCV IMV

hPa

S-IMV S-PCV SIM V

PCV

PSV SPSV PCV

IMV PCV IMV

S-IMV S-PCV SIM V

PCV

PSV SPCV

PSV

Freq. I:E / TInsp (except PSV) Plateau (except PSV) VTi (only IMV + S-IMV) PInsp / PMax Peep Trigger (only S-IMV, S-PCV, PSV) Backup (only PSV) Alarm thresholds

Child High

Low

Adult High

Low

MV VTe PPeak O2 Insp. CO2 Insp. CO2 Exp. Agent (DES, ISO, HAL, SEV, ENV)

Monitoring Value 1 Value 2 Value 3 Value 4 Value 5 Value 6 Value 7 Value 8 Charts Chart 1 Chart 2 Chart 3 Chart 4

Parameter page 1 (Standard: MV) (Standard: VTe) (Standard: PPeak (Standard: PPlateau) (Standard: MAC) (Standard: Compl.) (Standard: C20/C) (Standard: Resistance)

Parameter page 2 (Standard: MV) (Standard: VTe) (Standard: PPeak (Standard: PPlateau) (Standard: PMean) (Standard: Peep) (Standard: Freq.)

Y axis scale

Time axis scale

(Standard: Compl.)

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Chapter 5: Update Systemsoftware

5.2

Versions of software update

The following versions of software updates are possible: 

Update by Boot-CD. Read therefore chapter 5.3 Software update by Boot CD.



Update by network connection with static IP address. Read therefore chapter 5.4 Update by static IP address.



USB auto Update (in preparation). Read therefore chapter 5.6 USB auto Update (in preparation). This kind of update is only possible without kernel update.

5.3

Software update by Boot CD

5.3.1

Required materials



PC or notebook with o

Ethernet interface (10/100Mbit)

o

USB-interface



Crossed Ethernet network cable (crossover, Cat. 5)



special USB-to-serial adapter (Item no. 0170511)



Special serial cable (Item No. 0170503) required only for Kernel and Power Pic update.



zero modem adapter pol. m/f (Item No. 0170509) required only for Kernel update



min. 256 MB RAM



Boot-CD



possibly USB-stick

5.3.2

Preparations

5.3.2.1

Burning Boot-CD

If you have a Boot-CD available (without Software or older Software version), you can perform the update with this Boot-CD. The new software has to be present on a USBstick. Read therefore chapter 5.3.2.2 Procedure by existing Boot-CD. 

Make sure to have the actual software package with Boot-CD available (for example Leon_BOOTCD_V1_1_19.zip).



Decompress all files of the software package received and save the decompressed content in a separate, empty directory. The zip file itself is not part of the update.

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Chapter 5: Update Systemsoftware

Figure 5: contents of the zip-folder



Start the file “Burn Boot CD.bat” resp. “Click_me_to_burn.bat”.



The following program appears.

Figure 6: program Burn CD



Lay a CD in your CD writer and start the program “Burn CD”.



Follow the instruction in chapter 5.3.3 Update environment setup.

5.3.2.2 

Procedure by existing Boot-CD Make sure to have the actual software package available (for example: Leon_usb_manual_V1_1_19.zip).



Create a directory for the current software version on your USB-stick. The directory used must be empty in order to avoid conflicts with old or third party data.



Decompress the content of the software package and save the decompressed contents in the directory on the USB-stick. The zip file itself is not part of the update.



Follow the instruction in chapter 5.3.3 Update environment setup. In no case, rename files or folders.

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Chapter 5: Update Systemsoftware

5.3.3

Update environment setup

For a software update the following setup is necessary:

RJ45

Crossover Network Cable (Cat. 5) Figure 7: Update environment setup



Connect the device to your PC by crossover network cable (Ethernet). If you need an update with Kernel, you can set up the setup according to Figure 18, page 5-19.

5.3.4

Starting Update



Arrange booting from CD.



Special USB-adapter has to be plugged in before starting the PC.



If you offer the new Software on USB-stick, it has to be plugged in before starting the PC.



Lay your Boot-CD in your CD drive.



Start your PC (the Boot process starts).



This will last a few minutes because hardware detection is needed. If a network error appears, the network interface card of your PC / notebook is not identified. The update has to be done with another PC / notebook.

Figure 8: network error

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Chapter 5: Update Systemsoftware



The actual software version is shown on the desktop Software-Version update

Figure 9: Starting update tool



Wait until the explorer opens automatically. It will change to directory RAMDisk (B:), folder “LeonPlus” resp. “Leon”.

The explorer opens automatically and changes to directory RAMDisk (B :), folder LeonPlus or Leon

Figure 10: change to explorer



If you use a Boot CD with actual software, stay in this directory.



If the actual software is saved on your USB-Stick, you have to change to the respective folder with the new software (USB-stick) on your own.



Follow instructions on chapter 5.5 Start DEVICE_setup.exe.

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Chapter 5: Update Systemsoftware

5.4 .4 5.4.1 

Update by static IP address Required materials PC or notebook with o

separate USB-Ethernet adapter (recommended)

or o

Ethernet interface (10/100Mbit) of your PC

o

2 x USB interface Figure 11:USB-Ethernet Adapter



Crossed Ethernet network cable (crossover, Cat. 5)



Special USB-to-Serial Adapter (item no: 0170511)



Special serial cable (Item No. 0170503) required only for kernel and Power Pic update.



Null modem adapter pol. m/f (Item No. 0170509) required only for kernel update



min. 256 MB RAM

5.4.2 

Preparation Make sure to have the actual software package available (for example: Leon_usb_manual_V1_1_19.zip).



Decompress the content of the software package and save the decompressed contents in a separate, empty directory. The zip file itself is not part of the update.



Separate USB-Ethernet adapter: Install the USB-Ethernet adapter according to the instruction of the manufacturer.



Set up new LAN connection (e. g. LAN connection 2) as static IP address Make sure to set up the LAN connection of your USB-Ethernet adapter and not the LAN connection of the network interface of your PC.



Ethernet-interface: Set your PC's network settings to a static IP address.



Write down the current settings in order to restore them after the update, if necessary.

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Chapter 5: Update Systemsoftware

5.4.2.1

Set up static IP address

Ensure that the firewall on your PC is either configured accordingly or completely deactivated. For Windows XP, English: 

"Start" - open "Control Panel"



open "Network Connections"

For Windows 2000, English: 

"Start" - "Settings" - open "Network and Dialup Connections"

Both operating systems: 

Double click the "Local Area Connection 2" icon (USB-Ethernet adapter) resp. “Local Area Connection” (Ethernet interface)



Select "Properties" (only required for Ethernet interface)



"General" tab.



Select "Internet Protocol (TCP/IP)" from the list



Click on "Properties" button below it



"General" tab.



Select "Use the following IP address:"



IP address: 172.016.061.100



Subnet mask: 255.255. 0.0



Confirm dialog with "OK"

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Chapter 5: Update Systemsoftware

Figure 12: Set up static IP address (Windows 2000/Windows XP)

Ensure that the firewall on your PC is completely deactivated.

For Windows Vista, English: The description follows the modern view (not classic view) of the Control Panel 

"Start" - open "Control Panel" – “Network and Internet” - „Network and Sharing Center” – “Manage network connections”

For Windows 7, English: 

"Start" - "Control Panel" – “Network and Internet” – “Network and Sharing Center” – “Change adapter settings”

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Chapter 5: Update Systemsoftware

Both operating systems: 

Double click the "Local Area Connection 2" icon (USB-Ethernet adapter) resp. “Local Area Connection” (Ethernet interface)



Select "Properties" (only required for Ethernet interface)



"General" tab.



Double click on "Internet Protocol Version 4 (TCP/IP)" from the list



"General" tab.



Select "Use the following IP address:"



IP address: 172.016.061.100



Subnet mask: 255.255. 0.0



Confirm dialog with "OK"

Figure 13: Set up static IP address (Windows 7)

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Chapter 5: Update Systemsoftware

5.4.3

Update environment setup

For a software update the following setup is necessary:

RJ45

Crossover Network Cable (Cat. 5) Figure 14: Update environment setup

If you need an update with Kernel, you can set up the setup according to Figure 18, page 5-19. 

Connect the USB-Ethernet adapter to your PC (recommended)



Connect the device by crossover network cable (Ethernet) to your USB-Ethernet adapter.

If you do not use an USB-Ethernet adapter: 

Connect the device to your PC by crossover network cable (Ethernet). Make sure that during updating there is no connection to other networks (LANconnections). Deactivate existing WLAN-connections.



Navigate to the folder containing the actual software.



Follow instructions on chapter .

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Chapter 5: Update Systemsoftware

5.5 .5

Start DEVICE_setup.exe



Start the leonplus/leon



Start the file “DEVICE_setup.exe”

Start the file DEVICE_setup.exe with a double click

Figure 15: Starting DEVICE_setup.exe



Update program opens

Figure 16: Update program in AutoMode



If the leonplus/leon is identified, the program changes to “AutoMode”.



It is detected automatically which components need to be updated.



If the button “Complete-Installation” is activated and the instruction “Turn the device off!” (see Figure 16) appears, an update of the Kernel and Bootloader is necessary. Follow the manual under chapter 5.5.1 Update with Kernel, page 5-19.

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Chapter 5: Update Systemsoftware



If the button “Software-Update” is activated and the instruction “Press the “Software-Update” button to install the update in the device!” (see Figure 17) appears, an update of the Kernel is NOT necessary. Follow the manual under chapter 5.5.2 Update without Kernel, page 5-20.

Figure 17: Update exclusive Kernel



If you want to enforce a complete Update, follow the manual under chapter 5.5.3 Enforce a complete update, page 5-21.

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Chapter 5: Update Systemsoftware

5.5.1

Update with Kernel (Windows-CE platform)



Turn off the leonplus / leon.



Set up the following setup:

X15 (RJ45)

NET DCU

X27 (RJ45) Controller board

Zero modem adapter

Serial cable (RS232) Item no. 0170503

Crossover network cable (Cat. 5)

Figure 18: Setup Update with Kernel

The figure shows the Controllerboard of the leonplus. In leon, you find the board on the same position, but rotated 90 clockwise. 

Open the rear panel.



Connect the special serial cable with the zero modem adapter and the special USBto-serial adapter.



Connect the network cable.



By pressing the button “Complete-Installation” the update starts.



Follow the instructions of the program.

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Chapter 5: Update Systemsoftware

5.5.2 

Update without Kernel For all updates without Kernel, you do not need to change the setup

RJ45

Crossover-Netzwerk-Kabel (Cat. 5) Figure 19: Setup Update without Kernel



The network connection may not be plugged off!



By pressing the button “Software-Update” the update of all components, that need an update, starts.



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Follow the instructions of the program.

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Chapter 5: Update Systemsoftware

5.5.3

Enforce a complete update



You can enforce a complete update if it is necessary.



Therefore, turn off the device.



Set up the setup according to Figure 18



The update tool will show the message: No connection!

Figure 20: Enforce an update



Press the button “Complete-Installation”.



The message “Wait for connection!” is shown.



Turn on the leonplus/leon.



Follow the instructions of the program

Figure 21: „Wait for connection“ message

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Chapter 5: Update Systemsoftware

5.6 .6

USB auto Update (in preparation) This version of software update implies that no Kernel update (Windows CE-Plattform) is needed. See therefore Leon_Software_Versionsübersicht.pdf resp. Leon_Plus_Software_Versionsübersicht.pdf

5.6.1 

5.6.2 

Required material USB-Stick

Procedure Make sure to have the actual software package available (for example: Leon_usb_auto_V1_1_19.zip).



Decompress the content of the software package and save the decompressed contents in a separate, empty directory on your USB-Stick. The zip file itself is not part of the update.



The stick must contain two folders, “incoming” and “install”.



Save both folders on the highest level, not in a subdirectory.



In no case, rename the files and folders. In no case, rename files or folders. Save folders “incoming” and “install” on the highest level, not in a subdirectory.

5.6.3

Update environment



Open the rear panel of the device



Plug in the USB-Stick into the USB connector on the controller board

USBconnector

Controllerboard

Figure 22: USB-connector on controller board

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Chapter 5: Update Systemsoftware

5.6.4 

Starting Update Turn on the device during holding the “Mute-Alarm”-Button pressed

+

Hold the „Mute-Alarm“-Button pressed until the device has identified the USB-Stick.

Figure 23: Starting USB-Stick update



The update screen appears automatically on the device and the software download starts.

Figure 24: Update screen on the device



Follow the instruction of the device.

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Chapter 5: Update Systemsoftware

5.7 .7

Read logfiles



You have to start the program “DEVICE_setup.exe” to read logfiles



Set up the setup according to Figure 7.



Change to tab “Logfiles”.

Figure 25: read logfiles



Name a destination where to save the logfiles. This has to be a persistent memory (e.g. USB stick).



Enter the serial number leonplus / leon (at least the last 5 numbers).



Start the download by pressing the button “Download”.



The logfiles are saved in a folder on the USB stick. The folder is named by the serial number of the device.

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Chapter 5: Update Systemsoftware

5.8 .8 5.8.1

Power Pic Update Update environment setup (Power PIC)

The following setup is required for the Power PIC update:

X19 Reset button Power PIC

CFB

X5 (RJ45) X2 (RJ45)

Adapter board

Serial cable (RS232) Item no. 0170503

Figure 26: Setup Update Power Pic

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Chapter 5: Update Systemsoftware

5.8.2

Power-Pic update

. Go to the "Power Pic" directory in the update directory

Start "Download Tool.exe" by double-clicking it

Click „Select File“ Select file type "Hexfiles (*.hex)".

Double-click update file

Click „Next“

if necessary, select the COM interface here. Usually the correct COM port is recognized automatically.

Click „Next“

Figure 27: Power PIC update (page 1)

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X19 Reset-Button Pow. PIC X5 (RJ45) X2 (RJ45)

CFB

Press the Power Pics' reset button while the connection is established

Click „Start Download“

CAUTION! The update file transfer takes about 1 minute. Do not terminate the update process under any circumstances, as the adapter board might be damaged

X19 Reset Button Pow. PIC

Click „Exit“

X5 (RJ45) X2 (RJ45)

CFB

Press the reset button again after the file is transferred

Figure 28: Power PIC update (page 2)

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5.9 .9

Change PICs (Monitor PIC, Conductor PIC) Electrostatic discharges in the device

Risk of damage to the device  CAUTION



  

All work on the device must be done on a suitable earthed and conductive work surface (antistatic, ESD protection). Make sure that you are sufficiently earthed (e.g. 1 MΩ). Earth every instrument used during work on the ventilator Transport components and printed-circuit boards in the correct antistatic packages only.

Open the rear panel of the device. The PICs are located on the main board beneath the flow board.

Flow board

Figure 29: Open rear panel to change PICs



In the gap of the adapter board, the flow board is attached with three screws to the main board.

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

On the picture below, the main board is shown without adapter board on it, just because to have a better view of the whole matter. You do not need to remove the adapter board for changing the PICs.

Flow board

Main board

Figure 30: Main board and flow board



Remove the three screws and take off the flow board.



Do not lose the white foil between flow board and main board.

Conductor-PIC Monitor-PIC

Figure 31: Conductor-PIC and Monitor-PIC on main board



The small PIC is the Conductor PIC (old type 18F252 / new type 18F2520).



The big one is the Monitor PIC (type 15F877)



Remove the PIC by pulling it up vertically.

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Chapter 5: Update Systemsoftware

Conductor-PIC

groove

groove

Monitor-PIC

Figure 32: Groove on Conductor-PIC and Monitor-PIC



On one side of the PIC, there is a small half-round groove. When inserting the new PIC, this groove has to point to the inner side of the main board.



Make sure that all pins of the PIC are correctly in the socket and not bent aside.



Put together all parts in reverse order Do not forget the white foil between flow board and main board.

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chapter 6: Maintenance

6

Maintenance

Contents Page 6

Maintenance .................................................................................................6-1

6.1

Intervals..........................................................................................................6-5

6.2 6.2.1 6.2.2 6.2.3 6.2.3.1 6.2.3.2 6.2.3.3 6.2.3.4 6.2.3.5 6.2.3.6 6.2.4 6.2.5

Annual maintenance ......................................................................................6-6 Required tools ...........................................................................................6-6 Internal modules (annual maintenance) ....................................................6-7 Opening the rear panel..............................................................................6-9 Vaporiser holder..................................................................................6-10 O-Ringe water trap receptacle ............................................................6-11 Replacement int. O2 measurement cell (fresh gas) (only leonplus) ....6-12 Bacteria filter pressure measurement tube .........................................6-13 O-ring high pressure reducer gas box ................................................6-13 Closing the rear panel.........................................................................6-14 Anaesthetic vaporiser ..............................................................................6-15 Docking station (docking) ........................................................................6-16

6.3 6.3.1 6.3.2

10,000 hr. Maintenance (every 3 years) ......................................................6-19 Required tools .........................................................................................6-19 Replacing the batteries............................................................................6-20

6.4 6.4.1 6.4.2 6.4.2.1 6.4.2.2 6.4.3 6.4.4 6.4.5

20,000 hr. Maintenance (every 6 years) ......................................................6-22 Required tools .........................................................................................6-22 High pressure connections (pressure reducer) .......................................6-23 Removing gas box ..............................................................................6-25 Replacing the high pressure connections ...........................................6-26 Replacing pressure regulators connector block ......................................6-28 Replacing pressure regulators switch block ............................................6-29 Vaporiser holder ......................................................................................6-30

6.5 6.5.1 6.5.1.1 6.5.1.2 6.5.1.3 6.5.1.3.1 6.5.1.3.2 6.5.1.4 6.5.1.5 6.5.1.6 6.5.1.7 6.5.1.8 6.5.1.9 6.5.1.10 6.5.1.11 6.5.1.12 6.5.2 6.5.2.1 6.5.2.2 6.5.2.3 6.5.2.4 6.5.2.4.1

Maintenance patient module (closed loop system) ......................................6-31 Annual maintenance patient module (closed loop system) .....................6-31 Required tools.....................................................................................6-31 Preparation of the patient module.......................................................6-33 Absorber .............................................................................................6-35 Absorber Version I..........................................................................6-35 Absorber Version II.........................................................................6-35 Flow Sensors ......................................................................................6-36 Slide valve (Patient module bottom) ...................................................6-37 Absorber rotary valve..........................................................................6-38 PEEP Valve ........................................................................................6-39 Emergency air valve ...........................................................................6-41 Insp. / Exp. check valve ......................................................................6-42 Slide valve (Patient module top) .........................................................6-43 APL valve............................................................................................6-44 O-rings inspection glasses..................................................................6-45 6-year maintenance patient module (closed loop system) ......................6-46 Required tools.....................................................................................6-46 Opening the patient module................................................................6-48 Bellow holder ......................................................................................6-51 Absorber .............................................................................................6-52 Absorber Version I..........................................................................6-52 Heinen + Löwenstein, Service Manual leon/leonplus Rev. 2.2.2

6-1

chapter 6: Maintenance

6.5.2.4.2 6.5.2.5 6.5.2.6 6.5.2.7 6.5.2.8 6.5.2.9 6.5.2.10 6.5.2.11 6.5.2.12 6.5.2.13 6.5.2.14 6.5.2.15 6.5.2.16

Absorber Version II.........................................................................6-52 Flow Sensors ......................................................................................6-53 Slide valve (Patient module bottom) ...................................................6-54 Absorber rotary valve..........................................................................6-55 PEEP Valve ........................................................................................6-56 Emergency air valve ...........................................................................6-58 Patient module top/bottom connector .................................................6-59 Intermediate plate check valves..........................................................6-60 Heating connector (intermediate plate)...............................................6-62 Slide valve (Patient module top) .........................................................6-63 Excess diaphragm (Patient module top) .............................................6-64 APL valve............................................................................................6-66 Assembling the patient module...........................................................6-67

Figures Page Figure 1: Opening the rear panel ........................................................................................6-9 Figure 2: Internal modules ..................................................................................................6-9 Figure 3: Vaporiser holder ................................................................................................6-10 Figure 4: Selectatec seal ..................................................................................................6-10 Figure 5: Position water trap receptacle ...........................................................................6-11 Figure 6: O-rings water trap receptacle ............................................................................6-11 Figure 7: O2 cell drive gas generator ................................................................................6-12 Figure 8: Bacteria filter pressure measurement tube ........................................................6-13 Figure 9: O-rings high pressure reducer gas box .............................................................6-13 Figure 10: Close the rear panel ........................................................................................6-14 Figure 11: Close the rear panel ........................................................................................6-14 Figure 12: Docking station cushioning rings .....................................................................6-17 Figure 13: Docking staiont sealing rings ...........................................................................6-18 Figure 14: Plateau valve sealing ring................................................................................6-18 Figure 15: Rear panel of battery compartment .................................................................6-20 Figure 16: Disconnecting the batteries .............................................................................6-20 Figure 17: Connecting the batteries..................................................................................6-21 Figure 18: Removing the gas box .....................................................................................6-25 Figure 19: Detach high pressure connections ..................................................................6-26 Figure 20: Removing the high pressure connections........................................................6-26 Figure 21: Replacing the high pressure connection..........................................................6-27 Figure 22: Pressure regulators connector block ...............................................................6-28 Figure 23: Pressure regulators switch block .....................................................................6-29 Figure 24: Vaporiser holder ..............................................................................................6-30 Figure 25: Check valve .....................................................................................................6-30 Figure 26: Removing APL, domes ....................................................................................6-33 Figure 27: Removing the absorber ...................................................................................6-33 Figure 28: Removing the patient module ..........................................................................6-33 Figure 29: Removing the bellows......................................................................................6-34 Figure 30: Disassembling the absorber receptacle...........................................................6-34 Figure 31: Absorber Version I ...........................................................................................6-35 Figure 32: Absorber Version II ..........................................................................................6-35 Figure 33: Flow Sensors ...................................................................................................6-36 Figure 34: Slide valve patient module bottom ...................................................................6-37 Figure 35: Absorber rotary valve.......................................................................................6-38 Figure 36: PEEP diaphragm new (revision: hul101) and PEEP diaphragm old................6-40 Figure 37: PEEP Valve .....................................................................................................6-40 Figure 38: Emergency air valve ........................................................................................6-41 6-2

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chapter 6: Maintenance

Figure 39: Inspiration/Expiration valve ..............................................................................6-42 Figure 40: Slide valve (Patient module top) ......................................................................6-43 Figure 41: APL valve.........................................................................................................6-44 Figure 42: Valve domes assembly ....................................................................................6-45 Figure 43: Removing APL, domes ....................................................................................6-48 Figure 44: Removing the absorber ...................................................................................6-48 Figure 45: Removing the patient module ..........................................................................6-48 Figure 46: Removing the bellows......................................................................................6-49 Figure 47: Disassembling the absorber receptacle...........................................................6-49 Figure 48: Disassembling the bellows holder ...................................................................6-49 Figure 49: Dismantling patient module lock ......................................................................6-49 Figure 50: Opening the patient module.............................................................................6-50 Figure 51: Bellows holder .................................................................................................6-51 Figure 52: Absorber Version I ...........................................................................................6-52 Figure 53: Absorber Version II ..........................................................................................6-52 Figure 54: Flow Sensors ...................................................................................................6-53 Figure 55: Slide valve Patient module bottom ..................................................................6-54 Figure 56: Absorber rotary valve.......................................................................................6-55 Figure 57: PEEP diaphragm new (revision: hul101) and PEEP diaphragm old................6-57 Figure 58: PEEP Valve .....................................................................................................6-57 Figure 59: Emergency air valve ........................................................................................6-58 Figure 60: Patient module connector ................................................................................6-59 Figure 61: Check valves ...................................................................................................6-60 Figure 62: Inspiration/Expiration valve ..............................................................................6-61 Figure 63: Heating connector............................................................................................6-62 Figure 64: Slide valve (Patient module top) ......................................................................6-63 Figure 65: Excess diaphragm ...........................................................................................6-64 Figure 66: mountting position excess diaphragm .............................................................6-65 Figure 67: APL valve.........................................................................................................6-66 Figure 68: Closing the patient module ..............................................................................6-67 Figure 69: Lock assembly .................................................................................................6-67 Figure 70: Valve domes assembly ....................................................................................6-68

Tables Page Table 1: Contents of annual maintenance kit for internal modules .....................................6-7 Table 2: Internal module replacement parts .......................................................................6-8 Table 3: Contents of docking station maintenance kit ......................................................6-16 Table 4: Docking station replacement parts......................................................................6-16 Table 5 : Contents of maintenance kit for 10,000 hr. maintenance (Item no. 0209066) ...6-19 Table 6: 6 Year maintenance kit high pressure PIN-Index (0209070) ..............................6-23 Table 7: 6 Year maintenance kit high pressure DIN (0209075) ........................................6-23 Table 8: 6 Year maintenance kit high pressure PIN-Index without N2O (0209070-1) .......6-24 Table 9: 6 Year maintenance kit high pressure DIN without N2O (0209075-1).................6-24 Table 10: Gas box spare parts..........................................................................................6-24 Table 11: Contents of 12 months maintenance kit patient module ...................................6-32 Table 12: Contents of 3 years maintenance kit patient module ........................................6-47

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6-3

chapter 6: Maintenance

6.1

Intervals

Maintenance is separated into maintenance device and maintenance patient module. These parts could be performed independently from each other. Maintenance device: Every 12 months (maintenance):   

Annual Maintenance (chapter 6.2) System calibration (see chapter System Calibration) Tests (see chapter Tests)

Every 3 years or 10,000 operating hours (general overhaul):    

Annual Maintenance (chapter 6.2) 3-year (10,000 hr.) maintenance (chapter 6.3) System calibration (see chapter System Calibration) Tests (see chapter Tests)

Every 6 years or 20.000 operating hours (general overhaul):     

Annual Maintenance (chapter 6.2) 3-year (10,000 hr.) maintenance (chapter 6.3) 6-year (20,000 hr.) maintenance (chapter 6.4) System calibration (see chapter System Calibration) Tests (see chapter Tests)

Maintenance patient module: Every 12 months (maintenance)  

Annual maintenance patient module (chapter 6.5.1) Tests (see chapter Tests)

Every 6 years or 20.000 operating hours (general overhaul):  

6-year maintenance patient module (chapter 6.5.2) Tests (see chapter Tests)

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6-5

chapter 6: Maintenance

6.2

Annual maintenance

All small components, subject to particular mechanical and/or chemical wear and tear (e.g., through constant movement and exposure to anaesthetic gases) and that cannot be replaced by the operating personnel, should be replaced during annual maintenance. The external oxygen measurement cell (if there is one) does not necessarily require replacement during annual maintenance. Its aging process depends heavily on the operating conditions, which causes the service life of measurement cells to vary. The cells do not need to be replaced until calibration can no longer be performed. Operating personnel or hospital technical personnel can replace the cells.

6.2.1

Required tools

Tools required: 

Socket wrench (size: 5.5 mm)



Allen key (sizes 2mm, 2.5 mm, 3 mm, 4 mm, 5 mm (short))



Open end wrench (size: 10 mm, 25 mm, 32mm)



Cross-head screwdriver (size 1)



Torx wrench (size TX20)



Slotted screwdriver (size 0.4 x 2.5 mm) (Alternative: balancing instruments for trimming potentiometers)



Pliers for inner retaining rings

Materials required: Annual maintenance leonplus : 

Oxygen measurement cell (item no 0208766)



Internal module maintenance kit (Item no. 0209060-1)



Docking station maintenance kit (Item no. 0209055)

OR Annual maintenance leon 

Internal module maintenance kit (Item no. 0209060-1)



Docking station maintenance kit (Item no. 0209055)

Oxygen grease (Item no. 0150042)

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chapter 6: Maintenance

6.2.2

Internal modules (annual maintenance)

Internal module annual maintenance kit (Item no. 0209060-1): Module

Quan.

Item no.

Description

Rear panel

1

0209608

Filter for fan leon/leonplus

Vaporizer holder

4

0020005-1

O-ring check valve vaporizer

Gas measurement

2

0020166

O-rings for water trap receptacle

1

369-0343-00

Bacteria filter for pressure sample line

1

0020351

O-ring high pressure reducer DIN N2O

1

0020352

2

00203253

O-ring high pressure reducer DIN O2 O-rings high pressure reducer Pin Index O2 and N2O

Gas box

Table 1: Contents of annual maintenance kit for internal modules

Oxygen measurement cell leonplus (item no. 0208766) (only leonplus)

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chapter 6: Maintenance

Internal module spare parts: Module

Quan.

Item no.

Description

Vaporizer holder

4

0200499

Check valve, complete

Rear panel

1

0209005

Rear panel (fully assembled)

1

0208705

Adapter board (Rev. 0.3)

Generator module

Front module

1

0208708

Protocol interface (board)

1

0208710

Main board (Rev. 4.3)

1

0208915

Flow Adapter Board

1

0208935

Mains Connection Board

1

0209605

AC/DC converter (power supply module)

1

0209607

Fan screen (complete with filter)

1

0209608

Filter for fan screen

1

0217751

Fan

1

0208740

Generator module (complete)

1

0208750

Drive gas generator (complete)

1

0208750-1

Drive gas generator (w/o board)

1

0208750-2

Drive gas generator board (board only)

1

0208751

Fresh gas blender (complete)

1

0208751-1

Fresh gas blender (w/o board)

1

0208751-2

Fresh gas blender board (board only)

1

0208707

Controller board (complete)

0208800

Rotameter-block

Plateau valve

1

0208770

Plateau valve (block, complete)

Cabling

1

0208931

Fresh gas-O2 cell cable

Option panel

1

0208701

Battery connector cable

1

0208734

1

0208932

1

0208961

1

0208963

Controller board/adapter board connector cable Flow sensor cables (4 pin) (ACB -> Swiveling connector) Heat, absorber, PEEP cable (ACB -> Swiveling connector) Plateau valve/switch cable

1

0209971

Protocol interface cable

1

0209972

Sensor interface cable

1

0208623

1

0208635

Water trap receptacle (for devices with Oxima oxygen analyzer) Water trap receptacle (for devices with Servomex oxygen analyzer)

Table 2: Internal module replacement parts

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chapter 6: Maintenance

6.2.3

Opening the rear panel

Turn off the system! Pull out the mains plug (A)!

A

Remove screws (B) and open the rear panel (C). B

Also replace the filter on the housing fan (D) during this work step. D

C

Figure 1: Opening the rear panel

Figure 2: Internal modules

Check whether there are other necessary work steps in addition to annual maintenance that require opening the rear panel (e.g., replacement of the high pressure connections for 20,000 hr maintenance). Open device be running Danger of electrical shock DANGER



Unplug the leonplus / leon from the mains power when performing assembly work, including opening and closing the device.

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chapter 6: Maintenance

6.2.3.1

Vaporiser holder

The outer O-rings of the vaporiser holder (A) need to be replaced annually. Selectatec®- and Dräger® - compatible holders have the same check valves. Maintenance is therefore the same. A

Figure 3: Vaporiser holder

The O-rings (1) and the 4 check valves must be replaced

1

The following components must be replaced: No. Quan. Item no. Description O-ring check valve 1 4 0020005-1 vaporizer Figure 4: Selectatec seal

Check whether there are other necessary work steps in addition to annual maintenance (for 20,000 hr maintenance refers to step 6.4 on page 6-22).

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chapter 6: Maintenance

6.2.3.2

O-Ringe water trap receptacle

A A

Figure 5: Position water trap receptacle

If the unit comes with a water trap receptacle (A), the outer O-rings need to be replaced annually. The water trap receptacle is placed on the option plate or the option panel.

1

1

Figure 6: O-rings water trap receptacle

The following components must be replaced: No. Quan. Item no. Description 1 2 0020166 O-ring for water trap receptacle

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chapter 6: Maintenance

6.2.3.3

Replacement int. O2 measurement cell (fresh gas) (only leonplus)

Replace the O2 measurement cell (1). The cell is located above the fresh gas blender inside the device.

1

Figure 7: O2 cell drive gas generator

The following components must be replaced: No. Quan. Item no. Description 1 1 0208766 Oxygen measurement cell The new O2 measurement cell is automatically calibrated during the system test the next time the device is powered on. The sensor can also be calibrated from the Service menu (see chapter Calibration Procedure). Malfunction of the oxygen measurement cell Incorrect measurement of the oxygen concentration CAUTION

6-12



After calibration, run a 100% test to make sure the measurement cell is functioning properly. (Chapter 7 Calibration Procedure)

Heinen + Löwenstein, Service Manual leon/leonplus Rev. 2.2.2

chapter 6: Maintenance

6.2.3.4

Bacteria filter pressure measurement tube

Replace the bacteria filter (1) in the pressure measurement tube of the device.

1

Figure 8: Bacteria filter pressure measurement tube

The following components must be replaced: No. Quan. Item no. Description 1 1 369-0343-00 Bacteria filter pressure measurement tube 6.2.3.5

O-ring high pressure reducer gas box

Replace the O-rings of the high pressure reducer on gas box.

3 1

3

2

Figure 9: O-rings high pressure reducer gas box

The following components must be replaced: No. Quan. Item no. Description 1 1 0020351 O-ring high pressure reducer DIN O2 2 1 0020352 O-ring high pressure reducer DIN N2O 3 2 0020353 O-ring high pressure reducer Pin Index O2 and N2O

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6-13

chapter 6: Maintenance

6.2.3.6

Closing the rear panel

Close the rear panel when all maintenance and calibration tasks are completed. If other tasks need to be performed, finish those before closing up the device.

Turn off the system! Pull out the mains plug! When you close the rear panel, make sure the tubes and lines are not crimped or bent.

Figure 10: Close the rear panel

Screw the rear panel (B) back on the attachment points (A).

A B

Figure 11: Close the rear panel

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chapter 6: Maintenance

6.2.4

Anaesthetic vaporiser

The leonplus/leon has Selectatec® - or Dräger® - compatible vaporiser connections for 2 interlock compatible vaporisers. Corresponding products can be obtained from various manufacturers. All the anaesthetic vaporisers used on the leonplus/leon must be checked and maintained according to the manufacturer's instructions. The type, scope and intervals of the maintenance work can vary.

Conduct all necessary maintenance and service work on the anaesthetic vaporisers as specified in the manufacturer's service documents.

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6-15

chapter 6: Maintenance

6.2.5

Docking station (docking)

Docking station maintenance kit (Item no.: 0209055): Quan.

Item no.

Description

1

0020054

O-ring gas supply (fresh gas)

4

0020119

O-ring for gas supply

1

0020156

O-ring plateau valve - docking

6

0020168

O-ring for connection mandrel (small)

2

0020002

O-ring for connection mandrel (big)

Table 3: Contents of docking station maintenance kit

Docking station spare parts: Quan.

Item no.

Description

7

0020159

O-ring damping patient module

1

0208785

Peep valve (voice-coil)

1

0208786

Peep valve cover

1

0208788

Peep valve cover

2

0209101

Flow sensor socket (incl. cable)

1

0209102

Heating socket (incl. cable)

1

0209128

Absorber switch

1

0209295

Tube holder

Table 4: Docking station replacement parts

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chapter 6: Maintenance

The O-rings located directly in the recesses on the top of the docking station have no other function except mechanical cushioning! They do not come in contact with anesthetic gas nor are they subject to mechanical loads. Therefore they do not need to be replaced! The leonplus/leon is even safe to run without these O-rings. However, missing or damaged rings must be replaced with new O-rings.

The following parts are to be replaced if necessary: No. Quan. Item no. Description A 7 0020159 O-ring damping patient module

A A

A

Figure 12: Docking station cushioning rings

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chapter 6: Maintenance

It is not necessary to open or to dismount the docking station from the device during maintenance. Only open the docking station if you have to replace defective parts on the inside.

Docking station

The following components must be replaced: No. Quan. Item no. Description 1 4 0020119 O-ring for gas supply O-ring for connection 2 6 0020168 mandrel (small) O-ring for connection 3 2 0020002 mandrel (big) O-ring gas supply 4 1 0020054 (fresh gas) O-ring plateau valve 5 1 0020156 docking station

4 1

3

1

2 2 Figure 13: Docking staiont sealing rings

5

Figure 14: Plateau valve sealing ring

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chapter 6: Maintenance

6.3

10,000 hr. Maintenance (every 3 years)

The leonplus/leon requires a general overhaul after every 10,000 hours of operation or every three years, whichever comes first. The work steps for the 10,000 hr. maintenance are performed in addition to the work steps for the annual maintenance. During the 10,000 hr. maintenance, all components and modules are replaced that are not guaranteed to operate for more than 10,000 hours. Electrostatic discharge Damage to components and device    

CAUTION

6.3.1

All work on the device must be done on a suitable earthed and conductive work surface (antistatic, ESD protection). Make sure that you are sufficiently earthed (e.g. 1 MΩ). Earth every instrument used during work on the ventilator. Transport components and printed-circuit boards in the correct antistatic packages only.

Required tools

Tools required: 

For tools required for 3-year maintenance, refer to page 6-6



Slotted screwdriver (size 1.2 x 6.5 mm)

Materials required: 

Maintenance kit for 10,000 hr. maintenance (Item no. 0209066)

Maintenance kit for 10,000 hr. maintenance (Item no. 0209066): Module Batteries

Quant. Item no. 2 0208700

Description Leon Plus / Leon batteries

Table 5 : Contents of maintenance kit for 10,000 hr. maintenance (Item no. 0209066)

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chapter 6: Maintenance

6.3.2

Replacing the batteries Turn off the system! Pull out the mains plug! Remove both left screws (A) on the bottle holder and the screws (B) to remove the rear panel.

A

B

Figure 15: Rear panel of battery compartment

If your device is without drawers the rear panel covers the whole back of the device. You have to remove the rear panel to have access to the batteries.

Pull off the exhaust air tube (C)

D

Loosen the screws (D) enough to allow you to lift the battery holding plate (E) and remove the batteries.

E

D

C E

Figure 16: Disconnecting the batteries

The following components must be replaced: No. Quan. Item no. Description 1 2 0208700 Battery Leon/Leon plus

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chapter 6: Maintenance

Remove the wires from the battery connections (G)! Replace both batteries! Make sure you insert the new batteries with the poles in the correct direction (G)

G

G F

F Figure 17: Connecting the batteries

Switching the battery connections Severe damage to the device CAUTION



Make sure not to switch the battery connections

To reassemble, follow the instructions for disassembly in reverse.

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chapter 6: Maintenance

6.4

20,000 hr. Maintenance (every 6 years)

The leonplus/leon requires a general overhaul after every 20.000 hours of operation or every six years, whichever comes first. The work steps for the 20,000 hr. maintenance are performed in addition to the work steps for the 10,000 hour and the annual maintenance. During the 20,000 hr. maintenance, all components and modules are replaced that are not guaranteed to operate for more than 20,000 hours. Electrostatic discharge Damage to components and device    

CAUTION

6.4.1

All work on the device must be done on a suitable earthed and conductive work surface (antistatic, ESD protection). Make sure that you are sufficiently earthed (e.g. 1 MΩ). Earth every instrument used during work on the ventilator. Transport components and printed-circuit boards in the correct antistatic packages only.

Required tools

Tools required: 

Allen key (sizes 2mm, 2.5 mm, 3 mm, 4 mm, 5 mm (short))



Open end wrench (set, sizes 5.5 – 22)

Materials required: 

Maintenance kit 20,000h maintenance 0209070 or 0209075 depending on the device's version (DIN/PIN-Index)

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chapter 6: Maintenance

6.4.2

High pressure connections (pressure reducer)

6 Year maintenance kit high pressure PIN-Index (Art.-Nr. 0209070): (For devices with Pin-Index pressure reducers) Module

Quan..

Gas box

Vaporiser holder

Item-no.

Description

1 0209553

Pressure regulator connector block bottom

1 0209554

Pressure regulator connector block top

2 0209556

Pressure regulator switch block

1 0341006

O2 pressure reducer (generally Pin Index)

1 0341016

N2O pressure reducer (generally Pin Index)

1 0209040-1

O-ring Kit check valve

includes 4 0020005-1

O-ring upper part outside

4 0020081

O-ring valve housing top

4 0020173

O-ring valve housing bottom

4 0020174

O-ring valve housing outside (middle)

4 0020207

O-ring valve housing inside

Table 6: 6 Year maintenance kit high pressure PIN-Index (0209070)

6 Year maintenance kit high pressure DIN (Art.-Nr. 0209075): (For devices with DIN pressure reducers) Module

Quan.

Gas box

Vaporiser holder

Item-no.

Description

1 0209553

Pressure regulator connector block bottom

1 0209554

Pressure regulator connector block top

2 0209556

Pressure regulator switch block

1 0341001

O2 pressure reducer (generally DIN)

1 0341011

N2O pressure reducer (generally DIN)

1 0209040-1

O-ring Kit check valve

includes 4 0020005-1

O-ring upper part outside

4 0020081

O-ring valve housing top

4 0020173

O-ring valve housing bottom

4 0020174

O-ring valve housing outside (middle)

4 0020207

O-ring valve housing inside

Table 7: 6 Year maintenance kit high pressure DIN (0209075)

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chapter 6: Maintenance

6 Year maintenance kit high pressure PIN-Index without N2O (Art.-Nr. 0209070-1): (For devices with Pin-Index pressure reducer, without N2O) Module

Quan.

Gas box

Vaporiser holder

Item-no.

Description

1 0209553

Pressure regulator connector block bottom

1 0209554

Pressure regulator connector block top

2 0209556

Pressure regulator switch block

1 0341006

O2 pressure reducer (generally Pin Index)

1 0209040-1

O-ring Kit check valve

includes 4 0020005-1

O-ring upper part outside

4 0020081

O-ring valve housing top

4 0020173

O-ring valve housing bottom

4 0020174

O-ring valve housing outside (middle)

4 0020207

O-ring valve housing inside

Table 8: 6 Year maintenance kit high pressure PIN-Index without N2O (0209070-1)

6 Year maintenance kit high pressure DIN (Art.-Nr. 0209075-1): (For devices with DIN pressure reducer, without N2O) Module

Quan.

Gas box

Vaporiser holder

Item-no.

Description

1 0209553

Pressure regulator connector block bottom

1 0209554

Pressure regulator connector block top

2 0209556

Pressure regulator switch block

1 0341001

O2 pressure reducer (generally DIN)

1 0209040-1

O-ring Kit check valve

includes 4 0020005-1

O-ring upper part outside

4 0020081

O-ring valve housing top

4 0020173

O-ring valve housing bottom

4 0020174

O-ring valve housing outside (middle)

4 0020207

O-ring valve housing inside

Table 9: 6 Year maintenance kit high pressure DIN without N2O (0209075-1)

Gas box spare parts: Module

Quant. Item no.

Description

*1 0341005

O2 pressure reducer (Pin Index, new)

*1 0341015

N2O pressure reducer (Pin Index, new)

*1 0341000

O2 pressure reducer (DIN, new)

*1 0341010

N2O pressure reducer (DIN, new)

Table 10: Gas box spare parts

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chapter 6: Maintenance

6.4.2.1

Removing gas box Device connected to the gas supply Danger of damages to the device

CAUTION



Disconnect the device from the gas supply



Remove all bottles that are connected to the system

There are usually different high pressure connections (country-specific) depending on the configuration of the device on delivery. However, the replacement procedure is the same for all variants!

Unscrew the vacuum adjusting knob to be able to remove the gas box

Disconnect the screws (A) on the back panel of the gas box module. Pull the module out of the housing without disconnecting any tubes or cables.

A A Figure 18: Removing the gas box

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6-25

chapter 6: Maintenance

6.4.2.2

Replacing the high pressure connections

Remove the mounting screws (B) on the high pressure connections.

B

B Figure 19: Detach high pressure connections

Loosen the tube screw connections (C). Pull the pressure tubes from the PIF connectors (D). Then, remove the high pressure connectors (E) carefully from the rear panel. E

D C

Figure 20: Removing the high pressure connections

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chapter 6: Maintenance

Loosen the compression fitting (F) and detach the high pressure line (G) from the pressure reducer (H). Attach the high pressure line to the new pressure reducer. To reinstall the new high pressure connections, follow the instructions for deinstallation in reverse order.

H

F

G

Figure 21: Replacing the high pressure connection

During reassembly, make sure that the ends of the high pressure line (G) are seated firmly against the limit stop of the connections before you tighten the compression fittings.

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6-27

chapter 6: Maintenance

6.4.3

Replacing pressure regulators connector block Too high control pressure of the pressure reducer on connector block Damage of the excess diaphragm

CAUTION



Calibration control pressure after exchange pressure reducer (see chapter calibration) Replace both pressure regulators in the connector block. Therefore lose the screws (A).

gas box

1

A

A

A

2

The following components must be replaced: No. Quan. Item no. Description 1 1 0209554 Pressure regulator connector block bottom 2 1 0209553 Pressure regulator connector block top

Figure 22: Pressure regulators connector block

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chapter 6: Maintenance

6.4.4

Replacing pressure regulators switch block Wrong installed inlet pressures fresh gas blender Danger of damages to the device

CAUTION



Calibration of the fresh gas blender inlet pressures (see chapter system calibration) Replace both pressure regulators (1) in the switch block. Therefore lose the screws (A). In case of different revisions of the switch block you will find the pressure regulators in different positions

A

gas box

1

A

switch block Rev. 01/02 A

A

switch block Rev. 03

1

The following components must be replaced: No. Quan. Item no. Description 1 2 0209556 Pressure regulator switch block Figure 23: Pressure regulators switch block

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chapter 6: Maintenance

6.4.5

Vaporiser holder

Uncase the 4 check valves (A). Therefore firstly unscrew the 4 screws in the underside of the Vaporiser holder. The screws are accessible from inside the device.

A

Unscrew the upper part out of the valve housing and replace all O-rings of the valve.

Figure 24: Vaporiser holder

1

5

2

5

4

3

Figure 25: Check valve

The following components must be replaced: No. Quan. Item no. Description 1 4 0020005-1 O-Ring upper part outside 2 4 0020081 O-Ring valve housing top 3 4 0020173 O-Ring valve housing bottom 4 4 0020174 O-Ring valve housing outside (middle) 5 4 0020207 O-Ring valve housing inside

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chapter 6: Maintenance

6.5

Maintenance patient module (closed loop system) If you perform an annual maintenance patient module you ONLY perform the chapter annual maintenance patient module. If you do a 6-year maintenance patient module you ONLY perform the chapter 6year maintenance patient module.

6.5.1

Annual maintenance patient module (closed loop system)

All small components, subject to particular mechanical and/or chemical wear and tear (e.g., through constant movement and exposure to anaesthetic gases) and that cannot be replaced by the operating personnel, should be replaced during annual maintenance. 6.5.1.1

Required tools

Tools required: 

see required tools annual maintenance page 6-6

Materials required: 

patient module annual maintenance kit (Item no. 0209050)

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6-31

chapter 6: Maintenance

Patient module maintenance kit 12 months (Item no. 0209050): Patient module bottom Quan.

Patient module bottom/top

Patient module top

Absorber

1 1 2 4 1 1 1 1 1

Item no. 0020000 0020096 0020148 0020156 0020158 0020202 0020203 0205041 0209109

Description O-ring rotary valve outside (big) O-ring emergency air valve O-ring flow sensor O-ring rotary valve outside (small) O-ring PTFE rotary valve outside O-ring seal rotary valve O-ring bayonet fitting / PEEP Diaphragm emergency air valve PEEP valve diaphragm

9 3 3

Item no. 0020138 0020140 0020141

Description O-ring for slide valve (big) O-ring for slide valve (small) O-ring for cover/slide valve

2 2 2 2

Item no. 0020162 0020167 0020206 0209106

Description O-ring for inspection glass O-ring for valve seat for insp. / exp. O-ring for APL valve insp./exp. valve diaphragm

1 1 1

Item no. 0020153 0020163 0020180

Description O-ring absorber outside Flat seal inside for absorber Seal for absorber, version II

Quan.

Quan.

Quan.

Table 11: Contents of 12 months maintenance kit patient module

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chapter 6: Maintenance

6.5.1.2

Preparation of the patient module

Open the swivel arm with the patient module. Unscrew the APL valve (A) and both domes (B) from the top of the patient module.

B B

A

Figure 26: Removing APL, domes

Remove the absorber (C)!

C Figure 27: Removing the absorber

Release the lock (D) and take the patient module out of the docking station. D

Figure 28: Removing the patient module

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chapter 6: Maintenance

Next, remove the chamber and the bellows (E)

E Figure 29: Removing the bellows

Turn the patient module over and place it top down on a flat surface. Remove the three screws (F) and remove the holder (G) and rotary valve (H). Removing the rotary valve requires a bit of force. Turn the holder a little when pulling it out.

F

H

G

Figure 30: Disassembling the absorber receptacle

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chapter 6: Maintenance

6.5.1.3 6.5.1.3.1

Absorber Absorber Version I Replace the O-ring (1) and the flat seal (2) in the absorber lid.

1

2

Absorber Version I

The following components must be replaced: No. Quan. Item no. Description 1 1 0020153 O-ring absorber outside Flat seal inside for 2 1 0020163 absorber, version I Figure 31: Absorber Version I

6.5.1.3.2

Absorber Version II

1

Replace the O-ring (1) and the seal (2) in the absorber lid.

2

Absorber Version II

Folgende Teile sind zu ersetzen: Nr. Anz. Art.-Nr. Bezeichnung 1 1 0020153 O-Ring absorber outside 2 1 0020180 Seal, absorber version II Figure 32: Absorber Version II

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6-35

chapter 6: Maintenance

6.5.1.4

Flow Sensors Unscrew the lock nuts (A) and pull out the flow sensors at the tube connections (B). Replace the O-rings (1) at the sensors' end.

Patient module bottom

1 A

B

1 Figure 33: Flow Sensors

The following components must be replaced: No. Quan. Item no. Description 1 2 0020148 O-Ring flow sensor

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chapter 6: Maintenance

6.5.1.5

Slide valve (Patient module bottom) Remove the retaining ring (A), in order to remove the slide valve from the lower part of the patient module. Remove lid (B), slide valve (C) and spring (D), one after the other. The spring guide (E) does not have to be removed.

A Patient module bottom

E

D

C

B

D

C

A

B

The following components must be replaced: No. Quan. Item no. Description 1 1 0020141 O-ring for cover/slide valve 2 1 0020140 O-ring for slide valve (small) 3 3 0020138 O-ring for slide valve (big) Friction of slide valve too high, slide valve not tight Malfunction of the patient module/leakage CAUTION



Treat the O-Rings with a special oxygen grease

3

1

2 Figure 34: Slide valve patient module bottom

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chapter 6: Maintenance

6.5.1.6

Absorber rotary valve Replace all existing O-rings dismantled rotary valve (A).

on

the

under

B A Patient module bottom

A

B

The following components must be replaced: No. Quan. Item no. Description O-ring seal rotary 1 1 0020202 valve O-ring rotary valve 2 4 0020156 outside (small) O-ring rotary valve 3 1 0020000 outside (big) O-ring PTFE rotary 4 1 0020158 valve outside Friction of rotary valve too high, rotary valve not tight Malfunction of the patient module/leakage CAUTION



Treat the O-Rings with a special oxygen grease

1

4 3 2 (4x)

Figure 35: Absorber rotary valve

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0

chapter 6: Maintenance

6.5.1.7

PEEP Valve Remove the bayonet connector (A), remove the diaphragm (B) afterwards.

A

B

Patient module bottom

A

B

The following components must be replaced: No. Quan. Item no. Description PEEP valve 1 1 0209109 diaphragm O-ring bayonet fitting 2 1 0020203 PEEP

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chapter 6: Maintenance

Wrong assembly of the PEEP valve Malfunction of the device CAUTION



Make sure that the inlaying metal disk and the label TOP could be seen through the hole in the bayonet connector.

Figure 36: PEEP diaphragm new (revision: hul101) and PEEP diaphragm old

The PEEP diaphragm newest revision hul101 is marked red to make it easier to recognize the inlayed metal disk (see Figure 36). The metal disk is only visible to the front side of the diaphragm. 1

2

Figure 37: PEEP Valve

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chapter 6: Maintenance

6.5.1.8

Emergency air valve Remove the retaining ring (A) and pull the valve seat (B) out. Remove the valve (C). It is not mandatory to remove the cage (D) from the lower patient module part.

D

Patient module bottom

C

B A

B

C D

A

The following components must be replaced: No. Quan. Item no. Description Diaphragm 1 1 0205041 emergency air valve O-ring emergency air 2 1 0020096 valve

1

2

Figure 38: Emergency air valve

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6-41

chapter 6: Maintenance

6.5.1.9

Insp. / Exp. check valve Pull the valve seat (B) from the port (C), using the pins (A).

A

B C

Intermediate plate

A

B

C

The following components must be replaced: No. Quan. Item no. Description 1 2 0209106 valve diaphragm O-ring for valve seat 2 2 0020167 insp. / exp. Cut off the two fixing pins (D) of the valve diaphragm directly below the cone.

1

D

2

2x Figure 39: Inspiration/Expiration valve

6-42

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chapter 6: Maintenance

6.5.1.10

Slide valve (Patient module top) Remove the retaining ring (A), in order to remove the slide valves from the lower part of the patient module. Remove lid (B), slide valve (C), and spring (D) one after the other. The spring guide (E) does not have to be removed.

A

Patient module top

B E

D

C

E C

D

B

A

The following components must be replaced: No. Quan. Item no. Description O-ring for cover / slide 1 2 0020141 valve O-ring for slide valve 2 2 0020140 (small) O-ring for slide valve 3 6 0020138 (big) Friction of slide valve too high, slide valve not tight Malfunction of the patient module/leakage CAUTION



Treat the O-Rings with a special oxygen grease 1

3 2 Figure 40: Slide valve (Patient module top)

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6-43

chapter 6: Maintenance

6.5.1.11

APL valve

Open the bayonet connection (A) and remove the APL valve (B). Replace the O-rings for the APL valve. The O-ring for the APL-bayonet-fitting has to be replaced, if there is a defect!

Patient module top

B

A 2

1

The following components must be replaced: No. Quan. Item no. Description 1 2 0020206 O-ring for APL valve The following O-Ring must be replaced if it is defect: No. Quan. Item no. Description O-ring for APL-bayonet 2 1 0020046 fitting

Figure 41: APL valve

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chapter 6: Maintenance

6.5.1.12

O-rings inspection glasses

1

1

2

Remove both inspection glasses (1) above the inspiration and expiration valves.

Replace both O-rings (2), located in the inspection glasses.

The following components must be replaced: No. Quan. Item no. Description 12 2 0020162 O-ring for inspection glass

Figure 42: Valve domes assembly

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6-45

chapter 6: Maintenance

6.5.2

6-year maintenance patient module (closed loop system)

The patient module requires a general overhaul after every 20.000 hours of operation or every six years, whichever comes first. During the 20,000 hr. maintenance, all components and modules are replaced that are not guaranteed to operate for more than 20,000 hours.

6.5.2.1

Required tools

Tools required: 

see tools required annual maintenance, page 6-6

Materials required: 

6-46

maintenance kit patient module 6 years (item no. 0209050-1)

Heinen + Löwenstein, Service Manual leon/leonplus Rev. 2.2.2

chapter 6: Maintenance

Maintenance kit patient module 6 years (Item no. 0209050-1): Patient module bottom Quan.

Intermediate Plate

Patient module top

Absorber

1 4 1 1 3 1 1 1 2 4 1 1 1 1 1 1 1 1

Item no. 0020000 0020021 0020030 0020096 0020138 0020140 0020141 0020143 0020148 0020156 0020158 0020202 0020203 0020210 0020500 0205041 0209107 0209109

Description O-ring rotary valve outside (big) O-ring bellow holder (small) O-ring patient module underside O-ring emergency air valve O-ring for slide valve (big) O-ring for slide valve (small) O-ring for cover / slide valve O-ring bellow holder (big) O-ring flow sensor O-ring rotary valve outside (small) O-ring PTFE rotary valve outside O-ring seal rotary valve O-ring bayonet fitting / PEEP Flat seal, damping spring guidance Flat seal bellow holder Diaphragm emergency air valve Sealing cord lower part PEEP valve diaphragm

2 6 2 2 1

Item no. 0020110 0020149 0020167 0209106 0020022

Description O-ring for valve seat O-ring connectors patient module O-ring for valve seat for insp. / exp. Flap valve O-ring for heating connector

1 1 1 6 2 2 1 2 2 2 2 2 1

Item no. 151 233 E 0020046 0020056 0020138 0020140 0020141 0020146 0020162 0020205 0020206 0020210 0209106 0209108

Description Excess diaphragm O-ring APL-bayonet fitting O-ring patient module lock O-ring for slide valve (big) O-ring for slide valves (small) O-ring for cover/slide valve O-ring for pressure piece diaphr. seat O-ring for inspection glass O-ring seal diaphragm seat O-ring for APL valve Flat seal, damping spring guidance Insp./exp. valve diaphragm Sealing cord upper part

1 1 1

Item no. 0020153 0020163 0020180

Description O-ring absorber outside Flat seal inside absorber, version Seal for absorber, version II

Quan.

Quan.

Quan.

Table 12: Contents of 3 years maintenance kit patient module

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6-47

chapter 6: Maintenance

6.5.2.2

Opening the patient module

Open the swivel arm with the patient module. Unscrew the APL valve (A) and both domes (1) from the top of the patient module.

B B

A

Figure 43: Removing APL, domes

Remove the absorber (C)!

C Figure 44: Removing the absorber

Release the lock (D) and take the patient module out of the docking station D

Figure 45: Removing the patient module

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chapter 6: Maintenance

Next, remove the dome and the bellows (E)

E Figure 46: Removing the bellows

Turn the patient module over and place it top down on a flat surface. Remove the three screws (F) and remove the holder (G) and rotary valve (H). Removing the rotary valve requires a bit of force. Turn the holder a little when pulling it out.

F

H

G

Figure 47: Disassembling the absorber receptacle

Remove the four screws (I) on the underside of the bellows holder (J) and remove the holder.

I

J Figure 48: Disassembling the bellows holder

Loosen the threaded pins (K) of the lock (L) and carefully press the bolts (M) out.

M

K L

Figure 49: Dismantling patient module lock

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6-49

chapter 6: Maintenance

Remove the screws (O) on the underside of the patient module to separate the top, bottom, and intermediate plate from one another. Note that the screws have different lengths. This is important later when you are reassembling the patient module. Patient module (view from below)

O

O

Figure 50: Opening the patient module

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chapter 6: Maintenance

6.5.2.3

Bellow holder Replace the O-ring (1) and the O-rings (2) on the top of the bellows holder (A).

2

Patient module bottom 2

1

A

Replace the O-ring (3) in the bottom part of the patient module (B). Replace the flat seal (4) accordingly.

B

3

4

The following components must be replaced: No. Quan. Item no. Description 1 1 0020143 O-ring bellow holder (big) 2 4 0020021 O-ring bellow holder (small) 3 1 0020030 O-ring patient module underside 4 1 0020500 Flat seal bellow holder

Figure 51: Bellows holder

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chapter 6: Maintenance

6.5.2.4 6.5.2.4.1

Absorber Absorber Version I Replace the O-ring (1) and the flat seal (2) in the absorber lid.

1

2

Absorber Version I

The following components must be replaced: No. Quan. Item no. Description 1 1 0020153 O-Ring absorber outside Flat seal inside for 2 1 0020163 absorber, version I Figure 52: Absorber Version I

6.5.2.4.2

Absorber Version II

1

Replace the O-ring (1) and the seal (2) in the absorber lid.

2

Absorber Version II

The following components must be replaced: No. Quan. Item no. Description 1 1 0020153 O-Ring absorber outside 2 1 0020180 Seal, absorber version II Figure 53: Absorber Version II

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chapter 6: Maintenance

6.5.2.5

Flow Sensors Unscrew the lock nuts (A) and pull out the flow sensors at the tube connections (B). Replace the O-rings (1) at the sensors' end. Patient module bottom

1 A

B

1 Figure 54: Flow Sensors

The following components must be replaced: No. Quan. Item no. Description 1 2 0020148 O-Ring flow sensor

Heinen + Löwenstein, Service Manual leon/leonplus Rev. 2.2.2

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chapter 6: Maintenance

6.5.2.6

Slide valve (Patient module bottom) Remove the retaining ring (A), in order to remove the slide valve from the lower part of the patient module. Remove lid (B), slide valve (C), and spring (D) one after the other. The spring guide (E) does not have to be removed.

A Patient module bottom

E

D

C

B

D

C

A

B

The following components must be replaced: No. Quan. Item no. Description 1 1 0020141 O-ring for cover/slide valve 2 1 0020140 O-Ring for slide valve (small) 3 3 0020138 O-Ring for slide valve (big) Flat seal, damping spring 4 1 0020210 guidance Friction of slide valve too high, slide valve not tight Malfunction of the patient module/leakage CAUTION



Treat the O-Rings with special oxygen grease 3

4

1

2

Figure 55: Slide valve Patient module bottom

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chapter 6: Maintenance

6.5.2.7

Absorber rotary valve Replace all existing O-rings on the under 6.5.2.2 dismantled rotary valve (A).

B A Patient module bottom

A

B

The following components must be replaced: No. Quan. Item no. Description O-ring seal rotary 1 1 0020202 valve O-ring rotary valve 2 4 0020156 outside (small) O-ring rotary valve 3 1 0020000 outside (big) O-ring PTFE rotary 4 1 0020158 valve outside Friction of rotary valve too high, rotary valve not tight Malfunction of the patient module/leakage CAUTION



Treat the O-Rings with a special oxygen grease

1

4 3 2 (4x)

Figure 56: Absorber rotary valve

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6-55

chapter 6: Maintenance

6.5.2.8

PEEP Valve Remove the bayonet connector (A), remove the diaphragm (B) afterwards.

A

B

Patient module bottom

A

B

The following components must be replaced: No. Quan. Item no. Description PEEP valve 1 1 0209109 diaphragm O-ring bayonet fitting 2 1 0020203 PEEP

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chapter 6: Maintenance

Figure 57: PEEP diaphragm new (revision: hul101) and PEEP diaphragm old

The PEEP diaphragm newest revision hul101 is marked red to make it easier to recognize the inlayed metal disk (see Figure 36). The metal disk is only visible to the front side of the diaphragm.

Wrong assembly of the PEEP valve Malfunction of the device CAUTION



Make sure that the inlaying metal disk and the label TOP could be seen through the hole in the bayonet connector. 1

2

Figure 58: PEEP Valve

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6-57

chapter 6: Maintenance

6.5.2.9

Emergency air valve Remove the retaining ring (A) and pull the valve seat (B) out. Remove the valve (C). It is not mandatory to remove the cage (D) from the lower patient module part.

D

Patient module bottom

C

B A

B

C D

A

The following components must be replaced: No. Quan. Item no. Description Diaphragm 1 1 0205041 emergency air valve O-ring emergency air 2 1 0020096 valve

1

2

Figure 59: Emergency air valve

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chapter 6: Maintenance

6.5.2.10

Patient module top/bottom connector Replace the O-rings (1) of the patient module connector (A). Please note during the patient module's assembly that the connectors have different lengths. Exchange also the sealing cord (2).

Patient module bottom

A

2x Connector 11 mm

1

A

1x Connector 18 mm

1

The following components must be replaced: No. Quan. Item no. Description O-ring connectors 1 6 0020149 patient module Sealing Cord lower 2 1 0209107 part 2

Figure 60: Patient module connector

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chapter 6: Maintenance

6.5.2.11

Intermediate plate check valves Remove screws (A) and remove the valve seat (B).

B

Intermediate plate

A

1 2

B

The following components must be replaced: No. Quan. Item no. Description 1 2 0209106 valve diaphragm 2 2 0020110 O-ring for valve seat

Wrong assembly of the valve diaphragm/valve seat Leakage of the patient module CAUTION

 

Make sure that the side of the valve seat that faces the diaphragm has a sealing edge. Make sure that you insert the valve seat facing in the right direction. 1

2 Figure 61: Check valves

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chapter 6: Maintenance

Pull the valve seat (B) from the port (C), using the pins (A).

A

B C

Intermediate plate

A

B

C

The following components must be replaced: No. Quan. Item no. Description 1 2 0209106 valve diaphragm O-ring for valve seat 2 2 0020167 insp. / exp. Cut off the two fixing pins (D) of the valve diaphragm directly below the cone.

1

D

2

2x Figure 62: Inspiration/Expiration valve

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chapter 6: Maintenance

6.5.2.12

Heating connector (intermediate plate)

Replace the O-ring (1) of the heating connector (A) on the intermediate plate. 1

A

The following components must be replaced: No. Quan. Item no. description O-ring heating 1 1 0020022 connector

Figure 63: Heating connector

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chapter 6: Maintenance

6.5.2.13

Slide valve (Patient module top) Remove the retaining ring (A), in order to remove the slide valve from the lower part of the patient module. Remove lid (B), slide valve (C), and spring (D) one after the other. The spring guide (E) does not have to be removed.

A

Patient module top

B E

D

C

E C

D

B

A

The following components must be replaced: No. Quan. Item no. Description 1 2 0020141 O-ring for cover / piston O-ring for slide valve 2 2 0020140 (small) 3 6 0020138 O-ring for piston (big) Flat seal, damping 4 2 0020210 spring guidance Friction of slide valve too high, slide valve not tight Malfunction of the patient module/leakage CAUTION



Treat the O-Rings with a special oxygen grease 1

4

3

2

Figure 64: Slide valve (Patient module top)

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chapter 6: Maintenance

6.5.2.14

Excess diaphragm (Patient module top) Loosen the screws of the diaphragm plate (a). Remove the diaphragm disk (A), diaphragm (B) and the pressure piece (C) from the upper part of the patient module. Devices without the pressure piece do not contain the respective O-ring (No. 2, see below). B

Patient module top

C A

a

C B A

The following components must be replaced: No. Quan. Item no. Description O-ring for pressure piece 1 1 0020205 diaphr. seat 2* 1 0020146 O-ring seal diaphr. seat 3 1 151 233 E Excess diaphragm 4 1 0209108 Sealing cord upper part 4

(*only for devices with pressure piece (C))

Excess diaphragm not tight Malfunction of the patient module/leakage CAUTION



Treat the O-Rings with a special oxygen grease 3

2

1 Figure 65: Excess diaphragm

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chapter 6: Maintenance

Wrong assembly of the excess diaphragm Malfunction of the patient module CAUTION



Make sure that the side of the diaphragm without metal disk faces the diaphragm seat.

excess diaphragm on position

diaphragm seat on position

Figure 66: mountting position excess diaphragm

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chapter 6: Maintenance

6.5.2.15

APL valve

Open the bayonet connection (A) and remove the APL valve (B). Replace all visible O-rings!

Patient module top

B

A 1

2

The following components must be replaced: No. Quan. Item no. Description O-ring for APL-bayonet 1 1 0020046 fitting 2 2 0020206 O-ring for APL valve

Figure 67: APL valve

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chapter 6: Maintenance

6.5.2.16

Assembling the patient module

Reassemble the patient module by following the disassembly instructions in reverse (chapter 6.5.2.2, page 6-48). Please note that the screws for closing the patient module are of varying lengths.

Patient module (view from below)

B (4x35mm)

A

A

(4*40mm) Figure 68: Closing the patient module

Replace the O-ring (1) of the lock (C) before putting it back in the patient module.

The following components must be replaced: No. Quan. Item no. Description O-ring patient module 1 1 0020056 lock

1 C

Figure 69: Lock assembly

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chapter 6: Maintenance

O-rings inspection glasses

1

1

2

Remove both inspection glasses (1) above the inspiration and expiration valves.

Replace both O-rings (2), located in the inspection glasses.

The following components must be replaced: No. Quan. Item no. Description 12 2 0020162 O-ring for inspection glass

Figure 70: Valve domes assembly

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Chapter 7: Calibration

7

System Calibration

Contents Page 7.1 7.2

Intervals..........................................................................................................7-5 Differences leon/leonplus..............................................................................7-6

7.3

Required tools and testing equipment............................................................7-7

7.4

Test setup for flow measurement/calibration .................................................7-8

7.5 7.5.1 7.5.2

Test setup for pressure monitor/calibration....................................................7-9 Procedure leonplus: ................................................................................7-10 Procedure leon ........................................................................................7-10

7.6 7.6.1 7.6.2 7.6.3 7.6.4 7.6.5 7.6.6 7.6.7 7.6.7.1 7.6.7.2 7.6.8 7.6.8.1 7.6.8.2 7.6.9 7.6.9.1 7.6.9.2

Hardware calibration ....................................................................................7-11 Calibration bellow sensor ........................................................................7-12 Fresh gas blender inlet pressures (O2/AIR) – Gas box Rev001 ..............7-16 Fresh gas blender inlet pressure (O2/AIR/N2O) – Gas box Rev002 ........7-17 Fresh gas blender inlet pressures (O2/AIR/ N2O) – Gas box Rev003 .....7-19 Pilot pressure slide valves .......................................................................7-20 Pilot pressure excess diaphragm ............................................................7-21 Hardware calibration for airway pressure measurement .........................7-22 Old revision (Fresh gas and drive gas generator board separate) .....7-22 New revision (Fresh gas and drive gas generator board combined) ..7-23 Hardware calibration of inlet drive gas generator ....................................7-24 Old revision (Fresh gas and drive gas generator board separate) .....7-24 New revision (Fresh gas and drive gas generator board combined) ..7-25 Hardware calibration of fresh gas flow monitor .......................................7-27 Old revision (Fresh gas and drive gas generator board separate) .....7-27 New revision (Fresh gas and drive gas generator board combined) ..7-28

7.7 7.7.1 7.7.2 7.7.3 7.7.4 7.7.5

System software calibration .........................................................................7-29 Flow sensor calibration............................................................................7-30 Calibration of FiO2 measurement cell ......................................................7-32 Calibration of the fresh gas O2 measurement cell....................................7-33 Calibration of pressure sensor.................................................................7-34 Touch screen calibration: ........................................................................7-36

7.8 7.8.1 7.8.2 7.8.2.1 7.8.2.2 7.8.2.3 7.8.3 7.8.3.1 7.8.3.2 7.8.3.3

Calibration of the multi gas analyzer (Artema AION) ...................................7-37 Required tools and testing equipment .....................................................7-37 Calibration multi gas analyzer .................................................................7-38 Calibration gas span ...........................................................................7-39 Zero Ref. Valve Test ...........................................................................7-41 Span Calibration (100% calibration O2-sensor) ..................................7-42 Calibration Servomex O2-Sensor.............................................................7-44 Flow Sensitivity Calibration Servomex O2-Sensor ..............................7-44 21 % Adjustment Servomex (Hardware calibration) ...........................7-46 Gain Adjustment Servomex (Hardware calibration)............................7-48

Figures Page Figure 1: Test setup for calibration of fresh gas flow monitor .............................................7-8 Figure 2: Test setup for calibration of airway pressure monitor ..........................................7-9 Figure 3: alternative test setup pressure monitor................................................................7-9 Figure 4: Open the rear panels .........................................................................................7-12 Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.3

7-1

Chapter 7: Calibration

Figure 5: disconneting batteries........................................................................................7-12 Figure 6: removing batteries .............................................................................................7-13 Figure 7: bellow sensor.....................................................................................................7-13 Figure 8: Pressing the button............................................................................................7-14 Figure 9: LED bellow sensor.............................................................................................7-14 Figure 10: ON-position......................................................................................................7-14 Figure 11: OFF-position ....................................................................................................7-15 Figure 12: Setup of pressure reducer gas box Rev001 ....................................................7-16 Figure 13: O2 Gas box Rev001 inlet pressure ..................................................................7-16 Figure 14: O2 Gas box Rev001 inlet pressure ..................................................................7-16 Figure 15: Setup of pressure reducer gas box Rev002 ....................................................7-17 Figure 16: O2 Gas box Rev003 inlet pressure ..................................................................7-17 Figure 17: O2 Gas box Rev003 inlet pressure ..................................................................7-17 Figure 18: N2O Gas box Rev002 inlet pressure: (Type of gas).........................................7-18 Figure 19: N2O Gas box Rev002 inlet pressure (valves) ..................................................7-18 Figure 20: O2 Gas box Rev003 inlet pressure ..................................................................7-18 Figure 21: Setup of pressure reducer gas box Rev003 ....................................................7-19 Figure 22:O2 Gas box Rev003 inlet pressure...................................................................7-19 Figure 23: O2 Gas box Rev003 inlet pressure ..................................................................7-19 Figure 24: Position of pressure reducer for slide valve pilot pressure ..............................7-20 Figure 25: Adjustment pilot pressure slide valves.............................................................7-20 Figure 26: Position of pressure reducer for surplus diaphragm pilot pressure..................7-21 Figure 27: Adjustment pilot pressure surplus diaphragm..................................................7-21 Figure 28: Hardware calibration pressure monitor (old revision) ......................................7-22 Figure 29: Hardware calibration pressure monitor (new revision).....................................7-23 Figure 30: Hardware calibration of drive gas inlet pressure (old revision) ........................7-24 Figure 31: Hardware calibration of drive gas inlet pressure (new revision) ......................7-25 Figure 32: Hardware calibration of fresh gas flow monitor (old revision) .........................7-27 Figure 33: Hardware calibration fresh gas (new revision).................................................7-28 Figure 34: Zero point calibration Flow Sensor ..................................................................7-30 Figure 35: System calibration Flow Sensor ......................................................................7-31 Figure 36: Calibration of sensor........................................................................................7-32 Figure 37: Calibration of the fresh gas O2 measurement cell............................................7-33 Figure 38: Pressure sensor calibration (0 cmH2O) ...........................................................7-34 Figure 39: Pressure sensor calibration (60 cmH2O) .........................................................7-35 Figure 40: Testing the touchscreen ..................................................................................7-36 Figure 41: Test setup up gas measurement accuracy ......................................................7-38 Figure 42: Service menu gas span calibration..................................................................7-39 Figure 43: selection calibration gas type...........................................................................7-40 Figure 44: Service menu gas span calibration..................................................................7-40 Figure 45: Service menu Zero Ref. Valve-Test.................................................................7-41 Figure 46: 100% O2 calibration O2 sensor .......................................................................7-42 Figure 47: Test setup span calibration ..............................................................................7-43 Figure 48: Test setup flow calibration Servomex O2 Sensor.............................................7-44 Figure 49: Service menu calibration flow sensitivity Servomex O2 Sensor.......................7-45 Figure 50: Test setup 21% adjustment Servomex ............................................................7-46 Figure 51: Procedure 21% adjustment Servomex ............................................................7-47 Figure 52: Test setup 21% adjustment Servomex ............................................................7-48 Figure 53: Procedure 100% calibration.............................................................................7-49

Tables Page Table 1: Overview calibration hardware..............................................................................7-6 Table 2: Overview calibration software ...............................................................................7-6 7-2

Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.3

Chapter 7: Calibration

Table 3: Overview calibration optional components ...........................................................7-6 Table 4: settings PCV for calibration sensor.....................................................................7-13 Table 5: light state of the LED...........................................................................................7-15 Table 6: Calibration of drive gas inlet pressure.................................................................7-26

Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.3

7-3

Chapter 7: Calibration

7.1

Intervals

Maintenance device: Every 12 months (maintenance):   

Annual Maintenance (see chapter Maintenance) System calibration (see this chapter) Tests (see chapter Tests)

Every 3 years or 10,000 operating hours (general overhaul):    

Annual Maintenance (see chapter Maintenance) 3-year (10,000 hr.) maintenance (see chapter Maintenance) System calibration (see this chapter) Tests (see chapter Tests)

Every 6 years or 20.000 operating hours (general overhaul):     

Annual Maintenance (see chapter Maintenance) 3-year (10,000 hr.) maintenance (see chapter Maintenance) 6-year (20,000 hr.) maintenance (see chapter Maintenance) System calibration (see this chapter) Tests (see chapter Tests)

Maintenance patient module: Every 12 months (maintenance):  

Annual maintenance patient module (see chapter Maintenance) Tests patient module (see chapter Tests)

Every 6 years or 20.000 operating hours (general overhaul):  

6-year (20,000 hr.) maintenance patient module (see chapter Maintenance) Tests patient module (see chapter Tests)

Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.3

7-5

Chapter 7: Calibration

7.2

Differences leon/leonplus

The following tables contain the calibration procedures in line with the maintenance for the units leon and leonplus.

Calibration procedures Hardware Fresh gas blender inlet pressures (7.6.2– 7.6.4) Pilot pressure slide valves (7.6.5) Pilot pressure excess diaphragm (7.6.6) Hardware calibration for airway pressure measurement (7.6.7) Hardware calibration of inlet drive gas generator (7.6.8) Hardware calibration of fresh gas flow monitor (7.6.9)

leon X X X X -

leonplus X X X X X X

leon

leonplus

X X

X X

leon X

leonplus X

Table 1: Overview calibration hardware

Calibration procedures Software Flow sensor calibration (7.7.1) Calibration of the fresh gas O2 measurement cell (7.7.3) Calibration of pressure sensor (7.7.4) Touch screen calibration: (7.7.5) Table 2: Overview calibration software

Calibration optional components (if existent) Calibration of FiO2 measurement cell (7.7.2) Calibration multi gas analyzer (7.8.2) Calibration Servomex O2-Sensor (7.8.3) Calibration bellow sensor (7.6.1) Table 3: Overview calibration optional components

Explanation: X

=

Procedure required

-

=

Procedure not practicable

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Chapter 7: Calibration

7.3

Required tools and testing equipment

The following tools and testing equipment are required for the system calibration hardware:



Flow analyzer (e.g. PF-300)



Test tube system (3 tubes, 22mm M connector, reservoir bag, 22mm-22mm adapter)



Pressure measurement adapter with pressure sample line



Set of screwdrivers (flat head, Philips head)



Socket wrench 5.5 mm



Allen key (2.5mm)



Torx screwdriver (TX 20)



Trimmer utensils



Calibration gas (bottle) according to the following specifications: o o o o

Anaesthetic gas: Desflurane = 4% CO2 concentration = 6% N2O concentration = 45% O2 concentration = 45% The following applies to all gases: (for a = absolute accuracy of the gas concentration and c = gas concentration) a/c ≤ 0.01



Pressure reducer for calibration gas bottle



Flow meter tube (0-200ml/min, e.g. rotameter, or flow analyzer as an alternative)



Water trap with measurement tube

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7-7

Chapter 7: Calibration

7.4 .4

Test setup for flow measurement/calibration

Use the following test setup to perform the calibration of the fresh gas flow monitor (internal control measurement). Test setup:

Inlet: Low-Flow

Flow-Analyzer

Figure 1: Test setup for calibration of fresh gas flow monitor

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Chapter 7: Calibration

7.5 .5

Test setup for pressure monitor/calibration

Use the following test setup, to check airway pressure measurement calibration at 0 and 60 cmH2O. The setup applies to both, hardware and software calibration. Test setup:

leonplus / leon EXT FG / O2

BAG

INSP

EXP

Inlet: Low Pressure

Flow-Analyzer

Pressure measurement

Figure 2: Test setup for calibration of airway pressure monitor

If the device does not offer an external fresh gas resp. O2 outlet the BAG connection has to be short circuited to the test adapter of the patient module. Therefore the tube including connection adapter breathing bag has to be plugged on the test adapter.

leon(plus) BAG TEST ADAPTER INSP

EXP

test adapter Inlet: Low Pressure

Flow- Analyzer

BAG connection

Pressure sample line Figure 3: alternative test setup pressure monitor

Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.3

7-9

Chapter 7: Calibration

Procedure leonplus:

7.5.1

Navigate to the menu item "Service ►Device ►Valves": System without pressure 0 cmH2O: A C

Close all the fresh gas valves (press button A). Open the swivel arm with the patient module. Pressure build-up 60 cmH2O:

B

Make sure that AIR is selected (Button B disabled). Adjust the dose to 9 l/min fresh gas (button C). Using the APL valve, adjust the pressure to 60 cmH2O (value displayed on the flow analyzer). The adjusted value of the APL valve can deviate from the measured value.

7.5.2

Procedure leon

System without pressure 0 cmH2O: Make sure that there is no fresh gas flow (all spindles to zero). Open the swivel arm with the patient module. Pressure build-up 60 cmH2O: Lock the swivel arm. Make sure that fresh gas switch AIR is selected. Adjust the dose to 9 l/min fresh gas. Using the APL valve, adjust the pressure to 60 cmH2O (value displayed on the flow analyzer). The adjusted value of the APL valve can deviate from the measured value.

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Chapter 7: Calibration

7.6

Hardware calibration

The hardware calibration of the leonplus/leon ensures that the sensors for the control monitors of drive gas, fresh gas, and airway pressure provide accurate readings. To guarantee safe operation of the leonplus/leon, hardware calibration is extremely important. Calibration notices not followed Danger of incorrect calibration  CAUTION

 

Carry out a tightness test of the fresh gas blender respectively the rotameter block (pressure increase at fresh gas output max. 10 cmH2O in 30s, pressure decrease at 80 cmH2O maximum 20 cmH2O in 30s) (see chapter 8 Testing) Remove the gas measurement water trap (if there is one) Make sure that there really is no pressure in the system during the zero-point calibration of the pressure sensor (remove inspiration tube, close all fresh gas valves, open swivel arm if necessary).

Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.3

7-11

Chapter 7: Calibration

7.6.1

Calibration bellow sensor Opening of the device with mains power plugged in Danger of electrical shock

DANGER



Unplug the leonplus/leon from the mains power when opening the device.

Open the lower rear panel of the device. Turn off the device and pull out the mains plug! Remove both left screws (A) on the bottle holder and the screws (B) to remove the rear panel.

A

B

Figure 4: Open the rear panels

Pull off the exhaust air tube (C) Loosen the screws (D) enough to allow you to lift the battery holding plate (E) and remove the batteries.

D

C E

Figure 5: disconneting batteries

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Chapter 7: Calibration

Remove the wires from battery connections (G)!

the

F

Figure 6: removing batteries

The bore (G) of the bellow sensor (H) can be seen.

G H

Figure 7: bellow sensor

The sensor can only be calibrated in the first five minutes since turning on the device. Otherwise the device has to be restarted! Plug in the mains plug and start the device. Set up the following settings, but do not start ventilation!

setting

parameter

ventilation mode

PCV

FG O2

100 %

flow

0,2 l/min

frequency

40 1/min

I:E

4:1

plateau

90 %

Pinsp

40 cmH2O

PEEP

OUT

Table 4: settings PCV for calibration sensor

Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.3

7-13

Chapter 7: Calibration

Sensor in static teach-in-mode: Press button for appr. 2 sec. until the LED (green) is blinking. The blinking can be seen from the rear side through the bore.

button Figure 8: Pressing the button

LED green

LED yellow Figure 9: LED bellow sensor

Calibration ON-position: Set up the reinforcement ring directly in front of the sensor and press the button shortly. Reinforcement ring in front of the sensor press button

Figure 10: ON-position

Start ventilation with the above mentioned parameters! After a few breathings the bellow starts „to move up“.

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Chapter 7: Calibration

Calibration OFF-position: Press the button shortly when the bellow is NOT in front of the sensor. Calibration OFF-position with opened swivel arm Danger of incorrect calibration CAUTION



The dome MUST be in front of the sensor during calibration!

Dome in front of the sensor

press button Figure 11: OFF-position

Calibration was completed successfullyf the LED (green) glows for 2 sec. (can be seen from the back through the bore). Testing: Test the function of the fresh gas alarm sensor by starting ventilation with the above mentioned settings. After a few breathings the bellow starts „to move up“. The alarming ● freshgas shortage appears The alarming expires if fresh gas is supplied. Reconnect the wires from battery and the exhaust tube. Switching the battery connections Danger of severe damage CAUTION



Make sure to connect the batteries right

If the battery is disconnected, the battery management of the leon/leonplus) assumes that the battery has been replaced and starts automatic detection of the battery capacity. Therefore, it takes several hours for the charge to display correctly after a battery is connected.

Close the rear panel of the device. Lightstate of the LED: Teach Mode

bellow

green LED

yellow LED

off

down

off

on

off

up

off

off

on

down

blinking

off

on, when button pressed

on

up

blinking

off

on, when button pressed

Table 5: light state of the LED

Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.3

7-15

Chapter 7: Calibration

7.6.2

Fresh gas blender inlet pressures (O2/AIR) – Gas box Rev001

A defined inlet pressure is required for every type of gas to ensure the correct quantity and mix ratio of the applied fresh gas. The inlet pressures are selected so that the desired flow rate is obtained for each type of gas. Therefore, the pressure reducer setting must be checked regularly and corrected if necessary. Calibration of inlet pressures: The Rev001 gas box is equipped with two pressure reducers, for O2/AIR. (See picture for locations). IMPORTANT: The pressure reducer needs to be adjusted when connected to the actual gases (O2/Air). AIR pressure reducer

O2 pressure reducer

Figure 12: Setup of pressure reducer gas box Rev001

Adjusting O2 pressure reducer: A

Using the blender tube, adjust the fresh gas flow to 100% O2 at 9 l/min. The O2 pressure reducer has to be adjusted so that a flow of 9.2 l/min is measured at the fresh gas mandrel (A). Measurement: (Gas type: O2 man. 100% ATP)

Figure 13: O2 Gas box Rev001 inlet pressure

Adjust AIR pressure reducer: A

Using the blender tube, adjust the fresh gas flow to 21% O2 at 9 l/min. The AIR pressure reducer has to be adjusted so that a flow of 9.2 l/min is measured at the fresh gas mandrel (A). Measurement: (Gas type: Air ATP)

Figure 14: O2 Gas box Rev001 inlet pressure

Overview: Inlet pressure O2 AIR

7-16

Target value at 9 l/min dose 9.2 l/min ± 0.1 l/min 9.2 l/min ± 0.1 l/min

Measurement device gas type O2 man. 100% ATP Air ATP

Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.3

Chapter 7: Calibration

7.6.3

Fresh gas blender inlet pressure (O2/AIR/N2O) – Gas box Rev002 For devices with three gases and Gas box Rev002 (O2/AIR/N2O), there is an additional pressure reducer for adjusting the AIR inlet pressure. In order to adjust the N2O inlet pressure, the leonplus N2O connection line must be connected to AIR.

Calibration of inlet pressures: The Rev002 gas box is equipped with three pressure reducers, for O2/AIR and N2O. (See picture for locations). O2 pressure reducer

IMPORTANT: N2O pressure reducer AIR pressure reducer

The pressure reducers need to be adjusted when the system is connected to O2 and Air. For the calibration procedure, the N2O connection has to be connected to air.

Figure 15: Setup of pressure reducer gas box Rev002

Adjusting O2 pressure reducer: A

Using the blender tube, adjust the fresh gas flow to 100% O2 at 9 l/min. The O2 pressure reducer has to be adjusted so that a flow of 9.2 l/min is measured at the fresh gas mandrel (A). Measurement: (Gas Type: O2 man. 100% ATP)

Figure 16: O2 Gas box Rev003 inlet pressure

Adjust AIR pressure reducer: A

Using the blender tube, adjust the fresh gas flow to 21% O2 at 9 l/min. The AIR pressure reducer has to be adjusted so that a flow of 9.2 l/min is measured at the fresh gas mandrel (A). Measurement: (Gas type: Air ATP)

Figure 17: O2 Gas box Rev003 inlet pressure

Make a note of the measured flow value when adjusting the AIR pressure.

Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.3

7-17

Chapter 7: Calibration

Calibration of the N2O pressure reducer Danger of incorrect calibration  CAUTION



The AIR pressure reducer must be adjusted BEFORE the N2O pressure reducer. Make sure that the N2O inlet (Central Gas Supply) of the leonplus is supplied with AIR. Adjusting N2O pressure reducer: Go to the menu item: „Service ►Device ►Valves“:

A

A

Make sure that AIR is selected as the carrier gas (button A disabled)

Figure 18: N2O Gas box Rev002 inlet pressure: (Type of gas)

Now open as many fresh gas valves in the lower valve row (B) until you reach the exact flow value of the AIR pressure reducer that you noted earlier. B

Usually, you can reach this value fast by opening the valves 19, 21, 22, and 23.

A

Figure 19: N2O Gas box Rev002 inlet pressure (valves)

Now switch over to N2O as the carrier gas (Button A, Figure 18). Wait until the pressure reading on the fresh gas mandrel (C) has stabilized.

C

Measurement: (Gas type: Air ATP) To the extent possible, adjust the pressure reducer for N2O so that the measured flow value does not deviate from the AIR setting. (If necessary, switch over using button A multiple times) Figure 20: O2 Gas box Rev003 inlet pressure

Overview: Inlet pressure O2 AIR N2O

7-18

Target value at 9 l/min dose 9.2 l/min ± 0.1 l/min (blender setting) 9.2 l/min ± 0.1 l/min (blender setting) 9.2 l/min ± 0.1 l/min (valve setting)

Measurement device gas-type O2 man. 100% ATP Air ATP Air ATP

Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.3

Chapter 7: Calibration

7.6.4

Fresh gas blender inlet pressures (O2/AIR/ N2O) – Gas box Rev003

In devices with gas box Rev003 the pressure reducers for the fresh gas blender are accessible without opening the device. Only the cover panel has to be removed before the adjustment. Calibration of inlet pressures: The Rev003 gas box is equipped with two pressure reducers, for O2/AIR. (See picture for locations). O2 pressure reducer

AIR pressure reducer

IMPORTANT: The pressure reducer needs to be adjusted when connected to the actual gases (O2/Air).

Figure 21: Setup of pressure reducer gas box Rev003

Adjusting O2 pressure reducer: A

Using the blender tube, adjust the fresh gas flow to 100% O2 at 9 l/min. The O2 pressure reducer has to be adjusted so that a flow of 9.2 l/min is measured at the fresh gas mandrel (A). Measurement: (Gas type: O2 man. 100% ATP)

Figure 22:O2 Gas box Rev003 inlet pressure

Adjust AIR pressure reducer: A

Using the blender tube, adjust the fresh gas flow to 21% O2 at 9 l/min. The AIR pressure reducer has to be adjusted so that a flow of 9.2 l/min is measured at the fresh gas mandrel (A). Measurement: (Gas type: Air ATP) If your device is not equipped with AIR the adjustment can be done with N2O. Using the blender tube, adjust the fresh gas flow to 25% O2 at 9 l/min, carrier gas N2O. The pressure reducer has to be adjusted so that a flow of 9.2 l/min is measured at the fresh gas mandrel (A). Make sure that the flow is measured in gas type N2O/O2-man., 25%O2, ATP.

Figure 23: O2 Gas box Rev003 inlet pressure

Overview: Inlet pressure O2 AIR

Target value at 9 l/min dose 9.2 l/min ± 0.1 l/min 9.2 l/min ± 0.1 l/min

Measurement device gas type O2 man. 100% ATP Air ATP

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7-19

Chapter 7: Calibration

7.6.5

Pilot pressure slide valves

To ensure the correct switching of the slide valves in the patient module the pilot pressure has to be adjusted to the correct value.

Calibration pilot pressure slide valves: The pressure reducer (A) for the slide valve pilot pressure is the upper one on the connector block. A

Figure 24: Position of pressure reducer for slide valve pilot pressure

Procedure: Switch on the valve „Auto/Manual“ in the service mode.

Switching Auto / Manual

Measure the pressure on the connection mandrel (B) for the „Auto/Manual“ switching. The pressure on the connection mandrel (B) has to be between 1.0 and 1.2 kPa x 100 (bar). Check the correct adjustment of the pressure by switching the valve several times. B Inlet: High-Pressure

Flow-Analyzer

Pressure measurement tube

Figure 25: Adjustment pilot pressure slide valves

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Chapter 7: Calibration

7.6.6

Pilot pressure excess diaphragm

To ensure the correct function oft the excess diaphragm during the system test the pilot pressure hast to be adjusted to the correct value.

Calibration pilot pressure excess diaphragm: The pressure reducer (A) for the excess diaphragm pilot pressure is the lower one on the connector block.

A

Figure 26: Position of pressure reducer for surplus diaphragm pilot pressure

Procedure: Switch on the „Excess Diaphragm“ in the service mode. Excess diaphragm

Measure the pressure on the connection mandrel (B) for the „Excess Diaphragm“ pilot pressure. The pressure on the connection mandrel (B) has to be between 115 and 125 cmH2O. Check the correct adjustment of the pressure by switching the “Excess diaphragm” several times.

Inlet: Low-Pressure

Flow-Analyzer

Pressure measurement

B Figure 27: Adjustment pilot pressure surplus diaphragm

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Chapter 7: Calibration

7.6.7

Hardware calibration for airway pressure measurement

The airway pressure measurement works with two independent pressure sensors that monitor each other. For the system to operate properly, it is extremely important that both sensors be correctly calibrated. In the installed state, the calibration should be done using ADC values, since they are more accurate than calibration using voltages. Note different revisions of blender boards. 7.6.7.1

Old revision (Fresh gas and drive gas generator board separate)

Calibration Pressure sensor (DRM 3) is located on the drive gas generator board. Procedure: Remove the water trap from the gas monitor, if there is one For voltage calibration, connect multimeter between pin 1 (mass) and pin 2 of the pin strip. Zero:

gain Pin 2

In the pressureless state of DRM3 (0 cmH2O), use the "zero" trimmer to set a voltage of 200 mV (corresponds to DRM 3 ADC = 41). Gain:

Pin 1 zero

At 60 cmH2O on DRM3, set a voltage of 2.48 V using the "gain" trimmer (corresponds to DRM 3 ADC = 508).

Pressure sensor (DRM3) Airway pressure (Paw)

Overview:

DRM 3 ADC

Pressure 0 cmH2O 60 cmH2O

DRM 3 ADC 41 ± 1 508 ± 2

Voltage 200 ± 5 mV 2.48 ± 0.01 V

Figure 28: Hardware calibration pressure monitor (old revision)

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Chapter 7: Calibration

7.6.7.2

New revision (Fresh gas and drive gas generator board combined)

Calibration Pressure sensor (DRM 3) is located on the combined fresh gas and drive gas generator board.

zero

gain

Pressure sensor (DRM3) Airway pressure (Paw)

Procedure: Remove the water trap from the gas monitor, if there is one

Pin 1

For voltage calibration, connect multimeter between pin 1 (mass) and pin 4 of the pin strip. Zero:

Pin 4

In the pressureless state of DRM3 (0 cmH2O), use the "zero" trimmer to set a voltage of 200 mV (corresponds to DRM 3 ADC = 41). Gain:

DRM 3 ADC

At 60 cmH2O on DRM3, set a voltage of 2.48 V using the "gain" trimmer (corresponds to DRM 3 ADC = 508).

Figure 29: Hardware calibration pressure monitor (new revision)

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7-23

Chapter 7: Calibration

7.6.8

Hardware calibration of inlet drive gas generator

The drive gas for the bellows is metered independently of the supply pressure of the leonplus/leon. The calibration is done at 4 bar drive gas inlet pressure (please see configuration for the type of drive gas). If there is no 4 bar central gas pressure option for calibration, use the table on the following page to calibrate the inlet pressure. To perform the hardware calibration there are stable pressure ratios needed. Notice different revisions of blender boards. Inlet pressure drive gas up to Software Version 2.3.78: DRM 1 Inlet pressure drive gas from Software Version 3.0.0: DRM 2 7.6.8.1

Old revision (Fresh gas and drive gas generator board separate)

Calibration The pressure sensor (DRM1 resp. DRM2) is located on the drive gas generator board. Procedure: Connect multimeter between pin 1 (ground) and pin 3 of the pin contact strip. Zero: No adjustment necessary.

gain

Pin 3

Gain: At 4 bar on DRM1/2, set a voltage of 2.5 V using the "gain" trimmer (corresponds to DRM 1 resp. DRM2 ADC = 512).

Pin 1

Pressure sensor (DRM1 resp. DRM2) Drive gas inlet pressure Central gas supply inlet pressures

Overview: Pressure 4 bar

DRM 1/2 ADC

DRM 1 resp. DRM 2 ADC 512 ± 5*

Voltage

*or use the table on the following page

Figure 30: Hardware calibration of drive gas inlet pressure (old revision)

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2.5 ± 0.05 V

Chapter 7: Calibration

7.6.8.2

New revision (Fresh gas and drive gas generator board combined)

Calibration: Pressure sensor (DRM 1 resp. DRM2) is located on the combined fresh gas and drive gas generator board. Procedure: Connect multimeter between pin 1 (ground) and pin 3 of the pin contact strip. Zero: gain

No adjustment necessary. Gain:

Pressure sensor (DRM1/2) Drive gas inlet pressure

At 4 bar on DRM1 resp. DRM2, set a voltage of 2.5 V using the "gain" trimmer (corresponds to DRM 1/2 ADC = 512).

Overview: Pin 1 Pin 3

Pressure 4 bar

DRM 1 resp. DRM 2 ADC 512 ± 5*

Voltage 2.5 ± 0.05 V

*or use the table on the following page

Central gas supply inlet pressures

DRM 1/2 ADC

Figure 31: Hardware calibration of drive gas inlet pressure (new revision)

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7-25

Chapter 7: Calibration

Calibration of drive gas inlet pressure 4bar If it is not possible to calibrate the drive gas inlet pressure at 4 bar, calibrate the inlet pressure based on the existing supply pressure. Determine the selected drive gas ("Service ►Service ►Configuration“ menu). Read the supply pressure for the appropriate gas under "Supply pressures" in the "Service ►Device ►Monitor Pic" menu (see Figure 30: Hardware calibration of drive gas inlet pressure). Then set the value for “DRM 1/2 ADC” using the following table:

Central gas supply pressure in bar 2.8 2.9 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 4.0 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 5.0 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 6.0

ADC value DRM1 resp. DRM 2 382 ± 5 393 ± 5 404 ± 5 415 ± 5 426 ± 5 436 ± 5 447 ± 5 458 ± 5 469 ± 5 480 ± 5 490 ± 5 501 ± 5 512 ± 5 523 ± 5 534 ± 5 544 ± 5 555 ± 5 566 ± 5 577 ± 5 588 ± 5 598 ± 5 609 ± 5 620 ± 5 631 ± 5 642 ± 5 652 ± 5 663 ± 5 674 ± 5 685 ± 5 696 ± 5 706 ± 5 717 ± 5 728 ± 5

Voltage in V 1.87 ± 0.025 1.92 ± 0.025 1.97 ± 0.025 2.03 ± 0.025 2.08 ± 0.025 2.13 ± 0.025 2.18 ± 0.025 2.24 ± 0.025 2.29 ± 0.025 2.34 ± 0.025 2.39 ± 0.025 2.45 ± 0.025 2.50 ± 0.025 2.55 ± 0.025 2.61 ± 0.025 2.66 ± 0.025 2.71 ± 0.025 2.76 ± 0.025 2.82 ± 0.025 2.87 ± 0.025 2.92 ± 0.025 2.97 ± 0.025 3.03 ± 0.025 3.08 ± 0.025 3.13 ± 0.025 3.19 ± 0.025 3.24 ± 0.025 3.29 ± 0.025 3.34 ± 0.025 3.40 ± 0.025 3.45 ± 0.025 3.50 ± 0.025 3.55 ± 0.025

Table 6: Calibration of drive gas inlet pressure

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Chapter 7: Calibration

7.6.9

Hardware calibration of fresh gas flow monitor

The flow of the fresh gas blender is monitored with the help of a differential pressure sensor. In the installed state, the calibration should be done using the ADC value, since it is more accurate than calibration using voltages. Notice different revisions of blender boards. 7.6.9.1

Old revision (Fresh gas and drive gas generator board separate)

Calibration Pressure sensor (DRM 4) is located on the fresh gas genator board. Procedure: Set up Test setup for flow measurement/calibration, page 7-8. Connect multimeter between pin 1 (ground) and pin 2 of the pin contact strip. Zero: For zero pressure (all fresh gas valves closed), use the "zero" trimmer to set a voltage of 200 mV (corresponds to DRM 4 ADC = 41).

gain

Pin 2

zero

Pin 1

Gain: Open all the fresh gas valves for air (valve 8 and valves 16-23). Use the flow analyzer to measure the air flow at the fresh gas outlet. Then use the "gain" potentiometer to adjust the flow value measured by the leonplus to the value displayed on the flow analyzer.

Pressure sensor (DRM4) Fresh gas flow

Overview: Flow

Blender Fresh gas flow

0 l/min

DRM 4 ADC

Flow 18 l/min

DRM 4 ADC 41 ± 1

Voltage 200 mV

Blender fresh gas flow PF300 ± 2 l/min* display

* Always measure value with Flow Analyzer (ATP, Air) and set the measured value on leonplus.

Figure 32: Hardware calibration of fresh gas flow monitor (old revision)

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Chapter 7: Calibration

7.6.9.2

New revision (Fresh gas and drive gas generator board combined)

Calibration: Pressure senor (DRM 4) is located on the combined fresh gas and drive gas generator board. Procedure: zero

Set up for flow Test setup measurement/calibration, page 7-8. Connect multimeter between pin 1 (ground) and pin 5 of the pin contact strip.

gain

Zero: For zero pressure (all fresh gas valves closed), use the "zero" trimmer to set a voltage of 200 mV (corresponds to DRM 4 ADC = 41). Pressure sensor (DRM4) Fresh gas flow

Pin 5

Gain:

Pin 1

Open all the fresh gas valves for air (valve 8 and valves 16-23). Use the flow analyzer to measure the air flow at the fresh gas outlet. Then use the "gain" potentiometer to adjust the flow value measured by the leonplus to the value displayed on the flow analyzer.

Overview: Flow 0 l/min

Blender Fresh gas flow

Flow 18 l/min DRM 4 ADC

DRM 4 ADC 41 ± 1

Blender fresh gas flow PF300 ± 2 l/min* display

* Always measure value with Flow Analyzer (ATP, Air) and set the measured value on leonplus.

Figure 33: Hardware calibration fresh gas (new revision)

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Voltage 200 mV

Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.3

Chapter 7: Calibration

7.7

System software calibration

System calibration is designed to synchronize all the measurement components that monitor and control the ventilation system and the anaesthetic gas mixer.

System calibration has no impact on gas monitoring, which is covered separately.

Software update Danger of malfunction of the device ACHTUNG



Perform the system software calibration



Perform a system test (All calibrations, except the pressure calibration, are carried out automatically during the system test.)

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Chapter 7: Calibration

7.7.1

Flow sensor calibration

The system has one flow sensor each for the inspiration and expiration flow. Both are treated within the measurement unit as a single flow sensor. Therefore, only one flow sensor appears in the Service menu. The zero point calibration is automatically done in the system test. Zero point calibration: Navigate to the menu item "Service ►Service ►Flow calibration": 1

2

Figure 34: Zero point calibration Flow Sensor

3

Procedure: To ensure that there is no gas flow in the sensors during calibration, the procedure needs to be performed with the patient module on the opened swivel arm. 4

To start the zero point calibration, select "Zero point" ► Calibrate". Follow the instructions on the screen. If the message "No zero flow" appears (dialog 4), the device attempts another calibration (starting with dialog 2). If the zero calibration fails again, the entire procedure needs to be repeated. Error and warning messages are highlighted in yellow.

5

The message "Calibration finished" appears after the calibration completes successfully (dialog 5). In the screen "Flow calibration" (Figure 34) the date of the last calibration is now displayed under "Zero Point".

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Dialogs

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Chapter 7: Calibration

System calibration: A system calibration of the flow sensor mechanisms is basically not required A system calibration of the flow sensor mechanisms is basically not required as long as there are no deviations between the adjusted and the actually applied ventilation volumes (IMV, perfectly intact pneumatic system required)! The system calibration of the flow monitor is designed to compensate all the component tolerances within the measurement electronics. Calibration requires an "ETU" that can simulate the required flow values. Navigate to the menu item "Service ►Service ►Flow calibration": 1

2

Figure 35: System calibration Flow Sensor

3

Procedure: To start the system calibration, select "System" ► Calibrate". Follow the instructions on the screen. If a warning message appears (dialog 3), repeat the process starting at dialog 1. Error and warning messages are highlighted in yellow.

4

The message "Calibration finished" appears after the calibration completes successfully (dialog 4). In the screen "Flow calibration" (Figure 35) the date of the last calibration is now displayed under "System".

Dialogs

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Chapter 7: Calibration

7.7.2

Calibration of FiO2 measurement cell

Depending on the configuration, the leonplus/leon has an O2 measurement cell for measuring the inspiratory O2 content (FiO2). If is located on the inspiratory sight glass of the patient module. This measurement cell, if there is one, requires calibration.

FiO2 calibration: Go to the menu item: "Service ►Calibration ►FiO2“: 1

2

3 Figure 36: Calibration of sensor

Procedure: Select "21% Calib." to start the calibration at 21% oxygen (ambient air). If the calibration fails (dialog 2), repeat the procedure. If the message "Calibration finished" appears (dialog 3), the procedure has completed successfully. In the "Calibration" screen (Figure 36) the date of the last calibration is displayed under „FiO2“.

4

Dialogs

Often defective O2 measurement cells do not allow a calibration to 21% because a stable measurement state cannot be reached. Now select "100% Test" and follow the instructions on the screen (dialog 4). Wait until the display of the O2 value stabilizes at 100% before you close the dialog. If the calibration or the 100% test fails, the measurement cell is obviously defective and needs to be replaced. 7-32

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Chapter 7: Calibration

7.7.3

Calibration of the fresh gas O2 measurement cell (only leonplus)

The system has an oxygen measurement cell to monitor the fresh gas blender. It is also a fuel cell.

The calibration of the cell is automatically done in the system test. Fresh gas O2 calibration: Go to the menu item: "Service ►Calibration ►Fresh gas O2“: 1

2

3 Figure 37: Calibration of the fresh gas O2 measurement cell

Procedure: Select "21% Calib." to start the calibration at 21% oxygen (ambient air). If the calibration fails (dialog 2), repeat the procedure. If the message "Calibration finished" appears (dialog 3), the procedure has completed successfully. In the "Calibration" screen, (Figure 37) the date of the last fresh gas O2 calibration is displayed under "Fresh gas O2".

4

Dialogs

Often defective O2 measurement cells do not allow a calibration to 21% because a stable measurement state cannot be reached. Now select "100% Test" and follow the instructions on the screen (dialog 4). Wait until the display of the O2 value stabilizes at 100% before you close the dialog. If the calibration or the 100% test fails, the measurement cell is obviously defective and needs to be replaced. Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.3

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Chapter 7: Calibration

7.7.4

Calibration of pressure sensor

The airway pressure is monitored by two independent pressure sensors. The sensor placed on the mainboard needs to be included in the software calibration during system adjustment.

Pressure sensor calibration (0 cmH2O): Go to the menu item: "Service ►Calibration ►Pressure“: 1

2

3 Figure 38: Pressure sensor calibration (0 cmH2O)

Procedure:

Dialogs

To ensure that there is no pressure on the sensor during calibration, the procedure needs to be performed with the swivel arm open. Select "0 cmH2O Calib." to start the zero calibration of the pressure sensor. If the calibration fails (dialog 2), repeat the procedure. If the message "Calibration finished" appears (dialog 3), the procedure has completed successfully. In the "Calibration" screen, (Figure 38) the date of the last sensor calibration is displayed under "Pressure".

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Chapter 7: Calibration

Pressure sensor calibration (60 cmH2O): Test setup: Set up the test for pressure calibration (see chapter 7.5, page 7-9).

Go to the menu item: "Service ►Calibration ►Pressure“: 1

2

3 Figure 39: Pressure sensor calibration (60 cmH2O)

Dialogs

Procedure: Select "60 cmH2O Calib." to start the zero calibration of the pressure sensor. If the calibration fails (dialog 2), repeat the procedure. If the message "Calibration finished" appears (dialog 3), the procedure has completed successfully. In the "Calibration" screen, (Figure 39) the date of the last 60 cmH2O calibration is displayed under "Pressure".

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Chapter 7: Calibration

7.7.5

Touch screen calibration:

In the Service menu, select "Service ►Calibration".

Figure 40: Testing the touchscreen

Procedure: Press the "Calibrate touchscreen" button to start the calibration. Use your finger to conduct the test (rather than a PDA stylus or other tool.) Press all the crosshairs in the sequence displayed. Hold your finger on the surface until the next crosshair is displayed. When the calibration is finished, you will be prompted to exit it and press the "ESC" button. Therefore simply click anywhere on the touch surface.

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Chapter 7: Calibration

7.8

Calibration of the multi gas analyzer (Artema AION)

The multi gas analyzer needs to be calibrated when the gases are outside the allowable tolerances. The values need to be checked during annual maintenance. Calibration of the multi gas analyzer Danger of incorrect calibration CAUTION

Perform a calibration of the multi gas analyzer only if the accuracy test failed and the readings are out of tolerance.



Testing multi gas analyzer: Perform the following test items in the according order, if there is a problem regarding gas measurement. Test item Gas measurement leakage test Hardware calibration Servomex (if available) Flow sensitivity Servomex (if available) Span calibration (100% calibration O2 sensor) Gas measurement accuracy test Calibration gas span (only if accuray test fails)

7.8.1

Chapter Chapter 8.17.1 chapter 7.8.3.2 and 7.8.3.3 Chapter 7.8.3.1 Chapter 7.8.2.3 Chapter 8.17.2 Chapter 7.8.2.1

Required tools and testing equipment

The following tools and testing equipment are required for the inspection: 

Calibration gas (bottle) according to the following specifications: o o o o

Anaesthetic gas: Desflurane = 4% CO2 concentration = 6% N2O concentration = 45% O2 concentration = 45%

The following applies to all gases: (for a = absolute accuracy of the gas concentration and c = gas concentration) a/c ≤ 0.01 

Pressure reducer for calibration gas bottle



Flow meter tube (0-200ml/min, e.g. rotameter, or flow analyzer as an alternative)



Water trap with measurement tube

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Chapter 7: Calibration

7.8.2

Calibration multi gas analyzer

Preliminary steps/test setup: Excess pressure build up at the supply to the water trap Danger of damage to the device CAUTION

 

Never connect the calibration gas bottle directly to the water trap! Install a rotameter between calibration gas and water trap

Use the T connection to attach the calibration gas bottle to the rotameter or flow analyzer. Make sure that there is a positive gas flow against the ambient air at the rotameter/flow analyzer. This ensures that no ambient air enters the measurement setup and falsifies the measurement. Also do not use silicon tubes for the test equipment setup because they can falsify the measured values.

Rotameter (Flow-Analyzer)

> 0ml /min

T-Fitting

Water trap

Calibration gas

Figure 41: Test setup up gas measurement accuracy

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Chapter 7: Calibration

7.8.2.1

Calibration gas span

Procedure AION 03 with automatic gas detection (red) and AION 01 with N2O and CO2 detection (green): Gas measuring bench AION 01 (green) does not display any agent gas, only N2O and CO2. Go to the menu item: "Service ►AION“: Choose „Yearly Maintenance“ option „Gas Span Calibration ► Calibrate“

Figure 42: Service menu gas span calibration



Make sure that the multi gas analyzer is in "Full Accuracy" mode. If needed, wait several minutes until "Full Accuracy" mode is reached. Deactivate O2 calibration if your device is without integrated O2 measurement.



Open the valve to the test gas bottle carefully.



Wait until the readings have stabilized on the display (appr. 30 sec.).



Press the button “Calibrate” now. After a few seconds the message “Succeeded” appears on the top of the window.



Press the "OK" button to quit the procedure.



After finishing the procedure, the date of the last calibration appears behind “Gas Span Calibration”.

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Chapter 7: Calibration

Procedure AION 02 without automatic gas detection (orange): Before starting the test with gas measuring bench AION 02, the gas type has to be selected manually. 

Therefore, change to the ventilation screen and start any kind of ventilation



In the window of the gas measurement click on the unfilled place



In the opening window choose the gas type of your calibration gas

Figure 43: selection calibration gas type



Go to the menu item: "Service ►AION“:



Chose „Yearly Maintenance“ option „Gas Span Calibration ► Calibrate“

Figure 44: Service menu gas span calibration



Make sure that the multi gas analyzer is in “Full Accuracy" mode. If needed, wait several minutes until "Full Accuracy" mode is reached. Deactivate O2 calibration if your device is without integrated O2 measurement.

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Chapter 7: Calibration



Carefully open the valve to the test gas bottle.



Wait until the readings have stabilized on the display (appr. 30 sec).



Press the button “Calibrate” now. After a few seconds the Message “Succeded” appears on the top of the window.



Press the "OK" button to quit the procedure.



After finishing the procedure, the date of the last calibration appears behind “Gas Span Calibration”.

7.8.2.2

Zero Ref. Valve Test

Use the same test equipment setup as used for the gas span calibration (see chapter 7.8.2.1) Procedure: If your device is equipped with an AION without automatic gas detection (orange), you have to select your anesthetic gas first (see chapter 7.8.2.1, part: procedure AION without automatic gas detection (orange). If your device is equipped with an AION with automatic gas detection (red), this step is not necessary. AION 01 with N2O and CO2 detection (green) does not display any agent gas. Chose „Yearly Maintenance“ option „Zero Ref. Valve-Test► Calibrate“

Figure 45: Service menu Zero Ref. Valve-Test



Make sure that the gas monitor is in "Full Accuracy" mode. If needed, wait several minutes until "Full Accuracy" mode is reached.

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Chapter 7: Calibration



Carefully open the valve to the test gas bottle.



Wait until the readings have stabilized on the display.



Press the button “Calibrate” now. After a few seconds the Message “Succeeded” appears on the top of the window.



Press the "OK" button to quit the procedure.



After finishing the procedure, the date of the last calibration appears behind “Zero Ref. Valve-Test”.

7.8.2.3

Span Calibration (100% calibration O2-sensor)

Span Calibration is necessary, if the Oxima O2 sensor has been replaced or removed. Perform Span Calibration, if there are problems with the Servomex O2 sensor. Procedure: 

Start the leonplus/leon and wait appr. 2 minutes



Perform a 100% O2 calibration (Oxima and Servomex O2-measurement)



Change to service menu “Yearly Maintenance“ option ”Gas Span Calibration ► Calibrate“

100%, activated

Figure 46: 100% O2 calibration O2 sensor



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Deactivate all gases except oxygen and set the oxygen value to 100% Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.3

Chapter 7: Calibration



Make sure, 100 % oxygen reaching the water trap (see Figure 47)

leonplus / leon EXT FG / O2 INSP

BAG EXP

min. 30 cm

Figure 47: Test setup span calibration

If the device does not offer an external fresh gas resp. O2 outlet the BAG connection has to be short circuited to the test adapter of the patient module. Therefore the tube including connection adapter breathing bag has to be plugged on the test adapter (see chapter 7.5)

A

  

Open fresh gas valve 0 (A) to create an oxygen flow (leonplus) resp. create an oxygen flow by the O2spindle (leon) Set APL-valve to 90 cmH2O



Start calibration



The O2 measurement is now calibrated at 100% oxygen and ready for use Restart of the device is necessary after calibration procedure!

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Chapter 7: Calibration

7.8.3

Calibration Servomex O2-Sensor

7.8.3.1

Flow Sensitivity Calibration Servomex O2-Sensor

Preliminary steps/test setup: Use the following test setup to perform the calibration. Navigate to the menu item “Service ►Device ►Valves“:

leonplus / leon EXT FG / O2 INSP

BAG EXP

min. 30 cm

Figure 48: Test setup flow calibration Servomex O2 Sensor

If the device does not offer an external fresh gas resp. O2 outlet the BAG connection has to be short circuited to the test adapter of the patient module. Therefore the tube including connection adapter breathing bag has to be plugged on the test adapter (see chapter 7.5)

A

 

7-44

Open the fresh gas valve 0 (A) to create an oxygen flow. Set APL valve to 90 cmH2O

Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.3

Chapter 7: Calibration

Procedure: Navigate to the menu item “Service ►Artema AION ►Calibration“: Choose „Servomex Oxygen Sensor Calibration“ option „Sensor sensitivity ► Calibration“.

A Figure 49: Service menu calibration flow sensitivity Servomex O2 Sensor



Make sure that the gas monitor is in "Full Accuracy" mode. If needed, wait several minutes until "Full Accuracy" mode is reached.



Set the target value (A) to 100% O2.



Wait until the readings have stabilized on the display.



Press the button “Calibrate” now. After a few seconds the message “Succeeded” appears on the top of the window.



Press the "OK" button to quit the procedure.



After finishing the procedure, the date of the last calibration appears behind “Sensor sensitivity”.

Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.3

7-45

Chapter 7: Calibration

7.8.3.2

21 % Adjustment Servomex (Hardware calibration)

The 21 % adjustment has to be performed together with the gain adjustment. It is the hardware calibration of the Servomex. Hardware calibration is possible since software version 2.4.11. 

Open the rear panel of the device to be able to reach the Servomex O2 sensor



Set up the following test setup



Navigate to the menu item “Service ►Device ►Valves“:

leonplus / leon EXT FG / O2 INSP

BAG EXP

min. 30 cm

Figure 50: Test setup 21% adjustment Servomex

If the device does not offer an external fresh gas resp. O2 outlet the BAG connection has to be short circuited to the test adapter of the patient module. Therefore the tube including connection adapter breathing bag has to be plugged on the test adapter (see chapter 7.5)

A



Open the fresh gas valve 8 (A) to create a fresh gas flow.



Set APL valve to 90 cmH2O.

7-46

Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.3

Chapter 7: Calibration

Figure 51: Procedure 21% adjustment Servomex



Wait appr. 30 s for stabilization.



Turn adjustable screw zero to Raw signal 190 – 230 mV.



Close fresh gas valve 8 again.



The date of the last calibration is displayed at „21 % adjustment“.

Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.3

7-47

Chapter 7: Calibration

7.8.3.3

Gain Adjustment Servomex (Hardware calibration)

The gain adjustment has to be performed together with the 21 % adjustment. It is the hardware calibration of the Servomex. s Hardware calibration is possible since software version 2.4.11. 

Open the rear panel of the device to be able to reach the Servomex O2 sensor.



Set up the following test setup.



Navigate to the menu item “Service ►Device ►Valves“:

leonplus / leon EXT FG / O2

BAG

INSP

EXP

min. 30 cm

Figure 52: Test setup 21% adjustment Servomex

If the device does not offer an external fresh gas resp. O2 outlet the BAG connection has to be short circuited to the test adapter of the patient module. Therefore the tube including connection adapter breathing bag has to be plugged on the test adapter (see chapter 7.5)

A



Open the oxygen valve 2 (A) to create an oxygen gas flow.



Set APL valve to 90 cmH2O

7-48

Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.3

Chapter 7: Calibration

Figure 53: Procedure 100% calibration



Wait appr. 30 s for stabilization.



Turn adjustable screw gain to Raw signal 980 – 1020 mV



Close oxygen valve 2 again.



The date of the last calibration is displayed at „gain calibration“

Heinen + Löwenstein, Service Manual leonplus / leon Rev. 2.2.3

7-49

Chapter 8: Tests

8

Tests

Contents Page 8.1

Intervals......................................................................................................... 8-5

8.2

Required tools and testing equipment........................................................... 8-6

8.3

Test setup for flow monitor/calibration........................................................... 8-7

8.4 8.4.1 8.4.2

Test setup for pressure monitor/calibration ................................................... 8-8 Procedure leonplus:.................................................................................. 8-9 Procedure leon: ........................................................................................ 8-9

8.5

Testing process ........................................................................................... 8-10

8.6 8.6.1 8.6.2

General test items (visual inspection) ......................................................... 8-11 visual inspection ..................................................................................... 8-11 Internal visual inspection (tubing, cabling).............................................. 8-12

8.7 8.7.1 8.7.2 8.7.3 8.7.4 8.7.5 8.7.6 8.7.7 8.7.8 8.7.9 8.7.10 8.7.11

Testing gas supply ...................................................................................... 8-13 Fresh gas system tightness leon plus .................................................... 8-13 Fresh gas system tightness leon ............................................................ 8-16 Drive gas generator tightness................................................................. 8-19 Swivel arm/Docking tightness................................................................. 8-20 Drive gas switchover test........................................................................ 8-21 Tightness test in high pressure range* ................................................... 8-24 Reserve gas/Drive gas switchover* ........................................................ 8-25 Testing the drive gas generator .............................................................. 8-27 Fresh gas valve test (only leonplus) ....................................................... 8-30 Test of rotameter block ........................................................................... 8-31 Testing option panel*.............................................................................. 8-33

8.8 8.9

Test of hardware calibration ........................................................................ 8-34 Fresh gas blender total flow test (only leonplus)......................................... 8-37

8.10

Test of Software calibration......................................................................... 8-39

8.11

Testing the batteries.................................................................................... 8-44

8.12

Testing the operating modes....................................................................... 8-45

8.13 8.13.1 8.13.2 8.13.3 8.13.4 8.13.5

Testing the electronic control and display elements.................................... 8-47 Keypad test............................................................................................. 8-48 Display test ............................................................................................. 8-49 LED test.................................................................................................. 8-50 Sound test .............................................................................................. 8-51 Testing the touchscreen ......................................................................... 8-52

8.14 8.14.1 8.14.2 8.14.3 8.14.4

Testing the mechanical control and display elements................................. 8-53 Testing the O2 emergency dosing (only leonplus) .................................. 8-53 Testing the Flush (Bypassflow) (only leon)............................................. 8-55 Testing O2 auxiliary flow meter (optional) ............................................... 8-55 Vacuum injector and vacuum meter test* ............................................... 8-56

8.15 8.15.1 8.15.2 8.15.3 8.15.4

Control switch test ....................................................................................... 8-57 Ext. fresh gas control switch (if applicable)............................................. 8-58 Patient module control switch ................................................................. 8-59 Absorber control switch .......................................................................... 8-60 Bellow sensor * ....................................................................................... 8-61

8.16

Testing airway pressure measurement ....................................................... 8-62

8.17

Gas measurement test (SERVOMEX/OXIMA/AION/IRMA)* ...................... 8-63

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

8-1

Chapter 8: tests

8.17.1 8.17.2 8.17.3

Gas measurement leakage test.............................................................. 8-66 Gas measurement accuracy test ............................................................ 8-68 Zero reference valve test ........................................................................ 8-71

8.18 8.18.1 8.18.2 8.18.3 8.19

O2 monitor test ............................................................................................ 8-72 O2 sidestream measurement .................................................................. 8-72 O2 Mainstream monitor........................................................................... 8-74 O2 fuel cell .............................................................................................. 8-75 Functional test of fresh gas blender (overall function) (only leonplus) ........ 8-76

8.20

Function test of nitrous oxide gas lock (only leonplus)................................ 8-78

8.21

Docking check ............................................................................................. 8-81

8.22 8.22.1 8.22.2 8.22.3 8.22.4 8.22.5 8.22.6 8.22.7 8.22.8 8.22.9 8.22.10 8.22.11 8.22.12 8.22.13 8.22.14

Testing the patient module/circle system .................................................... 8-82 Testing the APL valve............................................................................. 8-85 Manual patient module leak test............................................................. 8-87 Step 1 ..................................................................................................... 8-88 Step 2 ..................................................................................................... 8-89 Step 3 ..................................................................................................... 8-90 Step 4 ..................................................................................................... 8-91 Step 5 ..................................................................................................... 8-92 Step 6 ..................................................................................................... 8-93 Step 7 ..................................................................................................... 8-94 Step 8 ..................................................................................................... 8-95 Step 9 ..................................................................................................... 8-96 Patient module test procedures (overview) ............................................ 8-97 Minimal-Flow test.................................................................................... 8-98 Heater function test ................................................................................ 8-99

8.23 8.23.1 8.23.2 8.23.3

Testing the ventilation function.................................................................. 8-100 Testing IMV mode (volume measurement)........................................... 8-100 Testing the PSV trigger ........................................................................ 8-103 Testing PCV mode (pressure control) .................................................. 8-105

8.24

Electrical safety test .................................................................................. 8-107

Figures Page Figure 1: Test setup for calibration of fresh gas flow monitor .............................................8-7 Figure 2: Test setup for calibration of airway pressure monitor ..........................................8-8 Figure 3: Alternative test setup pressure monitor ...............................................................8-8 Figure 4: Fresh gas system test........................................................................................8-13 Figure 5: Fresh gas switchover test ..................................................................................8-14 Figure 6: Test setup external fresh gas outlet tightness ...................................................8-15 Figure 7: check fresh gas system .....................................................................................8-16 Figure 8: Tightness swivel arm leon..................................................................................8-16 Figure 9: Fresh gas switchover test ..................................................................................8-17 Figure 10: Test setup external fresh gas outlet tightness .................................................8-18 Figure 11: Drive gas generator tightness ..........................................................................8-19 Figure 12: Swivel arm/Docking tightness ..........................................................................8-20 Figure 13: Drive gas switchover test (test setup) ..............................................................8-21 Figure 14: O2 test fresh gas branch (test setup) ...............................................................8-22 Figure 15: O2 test fresh gas branch (screen) ....................................................................8-23 Figure 16: Tightness test in high pressure range..............................................................8-24 Figure 17: Reserve gas switchover test (test setup) .........................................................8-25 Figure 18: Testing the drive gas generator (preliminary steps).........................................8-27 Figure 19: Testing the drive gas generator (test setup) ....................................................8-27 8-2

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

Chapter 8: Tests

Figure 20: Direct control of drive gas valves and control valves .......................................8-28 Figure 21: Direct control of the fresh gas valves...............................................................8-30 Figure 22: Rotameter block test ........................................................................................8-31 Figure 23: Switch emergency dosing ................................................................................8-33 Figure 24: Testing system calibration hardware ...............................................................8-34 Figure 25: Test setup voltage heater connector................................................................8-35 Figure 26: Cable for voltage measurement.......................................................................8-35 Figure 27: Voltage battery.................................................................................................8-36 Figure 28: Zero point calibration flow sensor ....................................................................8-39 Figure 29: Flow direction check ........................................................................................8-40 Figure 30: FiO2 (ADC 21% calib.) .....................................................................................8-41 Figure 31: Software calibration pressure sensors.............................................................8-42 Figure 32: Testing the touchscreen...................................................................................8-43 Figure 33: Testing the batteries ........................................................................................8-44 Figure 34: Testing the operating modes ...........................................................................8-45 Figure 35: Starting the advance service menu (Fab Test) ................................................8-47 Figure 36: Advanced Service menu: Keypad....................................................................8-48 Figure 37: Keypad test ......................................................................................................8-48 Figure 38 : Display test .....................................................................................................8-49 Figure 39: Turning off the display......................................................................................8-50 Figure 40: LED test ...........................................................................................................8-50 Figure 41: Sound test........................................................................................................8-51 Figure 42: Testing the touchscreen...................................................................................8-52 Figure 43: Testing O2 emergency dosing (connections) ...................................................8-53 Figure 44: Testing O2 emergency dosing (test setup).......................................................8-53 Figure 45: Position of the O2 emergency dosing ...............................................................8-54 Figure 46: Flush button position........................................................................................8-54 Figure 47: Position der Flush-Taste ..................................................................................8-55 Figure 48: Position of the O2 auxiliary flow meter..............................................................8-55 Figure 49: Vacuum injector connection.............................................................................8-56 Figure 50: Vacuum dosing ................................................................................................8-56 Figure 51: Control switch test............................................................................................8-57 Figure 52: External fresh gas control switch .....................................................................8-58 Figure 53: Patient module control switch ..........................................................................8-59 Figure 54: Absorber control switch....................................................................................8-60 Figure 55: Direct control of the control valves...................................................................8-62 Figure 56: Direct display of airway pressure .....................................................................8-62 Figure 57: Artema AION service menu .............................................................................8-63 Figure 58: Test setup for gas measurement leakage test.................................................8-66 Figure 59: Service menu gas measurement leak test.......................................................8-67 Figure 60: Test setup up gas measurement accuracy ......................................................8-68 Figure 61: Service menu gas monitor test ........................................................................8-69 Figure 62: Selection of the calibration gas ........................................................................8-70 Figure 63: Service menu gas monitor test ........................................................................8-70 Figure 64: Service menu zero reference valve test...........................................................8-71 Figure 65: O2 monitor test setup (sidestream) ..................................................................8-72 Figure 66: O2 oxygen measurement test settings .............................................................8-73 Figure 67: O2 oxygen measurement test...........................................................................8-73 Figure 68: O2 monitor test setup (mainstream) .................................................................8-74 Figure 69: O2 monitor test setup (fuel cell)........................................................................8-75 Figure 70: Test oxygen measurement FiO2 ......................................................................8-75 Figure 71: Test settings carrier gas "AIR" .........................................................................8-76 Figure 72: Test settings carrier gas "N2O" ........................................................................8-77 Figure 73: Nitrous oxide cutoff test (test setup) ................................................................8-78 Figure 74: Testing the pneumatic cutoff of nitrous oxide ..................................................8-80 Figure 75 : Docking check.................................................................................................8-81 Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

8-3

Chapter 8: tests

Figure 76: Patient module overview..................................................................................8-82 Figure 77: Patient module overview (diagram) .................................................................8-83 Figure 78: Overview of tube connections..........................................................................8-84 Figure 79: Testing the APL valve (connections) ...............................................................8-85 Figure 80: Testing the APL valve (test arrangement) .......................................................8-85 Figure 81: APL test fresh gas settings leonplus................................................................8-86 Figure 82: Manual patient module leak test (test setup) ...................................................8-87 Figure 83: Patient module test – step 1 ............................................................................8-88 Figure 84 : Patient module test – step 2 ...........................................................................8-89 Figure 85 : Patient module test – step 3 ...........................................................................8-90 Figure 86 : Patient module test – step 4 ...........................................................................8-91 Figure 87 : Patient module test – step 5 ...........................................................................8-92 Figure 88 : Patient module test – step 6 ...........................................................................8-93 Figure 89 : Patient module test – step 7 ...........................................................................8-94 Figure 90 : Patient module test – step 8 ...........................................................................8-95 Figure 91 : Patient module test – step 9 ...........................................................................8-96 Figure 92 : Testing IMV mode (test setup for volume measurement) .............................8-100 Figure 93 : Testing the PSV trigger (test setup)..............................................................8-103 Figure 94 : Testing PCV mode pressure control (test setup) ..........................................8-105

Tables Page Table 1: Test parameters for drive gas valves ..................................................................8-29 Table 2: Fresh gas blender test ........................................................................................8-31 Table3: Testing ratio system .............................................................................................8-32 Table 4: Settings testing rotameter ...................................................................................8-33 Table 5: Settings testing operating modes........................................................................8-45 Table 6: O2 emergency dosing testing parameters ...........................................................8-54 Table 7: testing the Flush-button.......................................................................................8-55 Table 8: O2 auxiliary flow meter testing parameters..........................................................8-55 Table 9: Vacuum injector and vacuum meter test parameters..........................................8-56 Table 10: Settings for testing fresh gas alarm...................................................................8-61 Table 11: Test parameters for airway pressure measurement .........................................8-62 Table 12: Accuracy of sidestream gas measurement .......................................................8-64 Table 13: settings O2-measurement.................................................................................8-73 Table 14: O2 monitor testing parameters ..........................................................................8-73 Table 15: Patient module components (overview) ............................................................8-82 Table 16: Patient module components (schematics) ........................................................8-83 Table 17: Overview of tube connections ...........................................................................8-84 Table 18: APL test parameters .........................................................................................8-86 Table 19: Patient module test table...................................................................................8-97 Table 20: IMV mode testing parameters .........................................................................8-102 Table 21: Testing parameters PSV Trigger.....................................................................8-104 Table 22: Testing parameters PCV-Mode: Pinsp............................................................8-106 Table 23: Testing parameters PCV mode: PEEP ...........................................................8-107

8-4

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Chapter 8: Tests

8.1

Intervals

Maintenance device: Every 12 months (maintenance):   

Annual Maintenance (see chapter Maintenance) System calibration (see chapter Calibration Procedure) Tests (this chapter)

Every 3 years or 10,000 operating hours (general overhaul):    

Annual Maintenance (see chapter Maintenance) 3-year (10,000 hr.) maintenance (see chapter Maintenance) System calibration (see chapter Calibration Procedure) Tests (this chapter)

Every 6 years or 20.000 operating hours (general overhaul):     

Annual Maintenance (see chapter Maintenance) 3-year (10,000 hr.) maintenance (see chapter Maintenance) 6-year (20,000 hr.) maintenance (see chapter Maintenance) System calibration (see chapter Calibration Procedure) Tests (this chapter)

Maintenance patient module: Every 12 months (maintenance):  

Annual maintenance patient module (see chapter Maintenance) Tests patient module (see this chapter)

Every 6 years or 20.000 operating hours (general overhaul):  

6-year (20,000 hr.) maintenance patient module (see chapter Maintenance) Tests patient module (see this chapter)

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

8-5

Chapter 8: tests

8.2

Required tools and testing equipment

The following tools and testing equipment are required for the inspection: 

Pressure/flow meter, calibrated (e.g. H+L flow analyzer, Item No. 0237000)



Test lung (e.g. Ingmar-QuickLung) with adjustable resistance and compliance



Rotameter (0-200ml/min, or flow analyzer as an alternative)



Calibration gas (Item No, 0208610) according to the following specifications: o o o o

Anesthetic gas: Desflurane 4% CO2 concentration: 6% N2O concentration: 45% O2 concentration: 45%

The following applies to all gases: (for a = absolute accuracy of the gas concentration and c = gas concentration) a/c ≤ 0.01

8-6



Pressure reducer for calibration gas cylinder (Item No. 0208611)



Various 22 mm tubes (with smooth inner wall)



M Connector for tube system (e.g. Item No. 0205003)



T-piece with tube (pressure measurement adapter, e.g. Item No. 0200150)



Adapter 22 mm internal diameter each (e.g. Item No. 110-1967)



Adapter for oxygen measurement cell (e.g. Item No. 0045004) (only for devices with external O2 fuel cell required)



Adapter for High Flow Inlet PF300 (e.g. Item No. 0205007)



Connector for heating (Item No. 0209127)



Test tube for O2 sidestream measurement (Item No. 0209091)

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

Chapter 8: Tests

8.3

Test setup for flow monitor/calibration

Use the following test setup to perform the calibration of the fresh gas flow monitor (internal control measurement). Test setup:

Flow-Analyzer Inlet: Low-Flow

Figure 1: Test setup for calibration of fresh gas flow monitor

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

8-7

Chapter 8: tests

8.4

Test setup for pressure monitor/calibration

Use the following test setup, to check airway pressure measurement calibration at 0 and 60 cmH2O. The setup applies to both hardware and software calibration. Test setup:

leon(plus) EXT FG / O2

BAG

INSP

EXP

Inlet: Low Pressure

Flow- Analyzer

Pressure sample line Figure 2: Test setup for calibration of airway pressure monitor

If the device does not offer an external fresh gas resp. O2 outlet the BAG connection has to be short circuited by the test adapter of the patient module. Therefore the tube including connection adapter of the breathing bag has to be plugged on the test adapter.

leon(plus) BAG TEST ADAPTER INSP

EXP

test adapter Inlet: Low Pressure

Flow- Analyzer

BAG connection

Pressure sample line Figure 3: Alternative test setup pressure monitor

8-8

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

Chapter 8: Tests

Procedure leonplus:

8.4.1

Go to the menu item: "Service ►Device ►Valves“: Pressureless system 0 cmH2O: A

Close all the fresh gas valves (press button A). Open the swivel arm with the patient module.

C

Pressure build-up 60 cmH2O: Lock the swivel arm. B

Make sure that AIR is selected. (Button B disabled). Adjust the dose to 9 l/min fresh gas (button C). Using the APL valve, adjust the pressure to 60 cmH2O (value displayed on the flow analyzer). The adjusted value of the APL valve can deviate from the measured value.

8.4.2

Procedure leon:

Pressureless system 0 cmH2O: Make sure that there is no fresh gas flow. Open the swivel arm with the patient module. Pressure build-up 60 cmH2O: Lock the swivel arm. Make sure that AIR is selected (Carrier gas switch on AIR). Adjust the dose to 9 l/min fresh gas. Using the APL valve, adjust the pressure to 60 cmH2O (value displayed on the flow analyzer). The adjusted value of the APL valve can deviate from the measured value.

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

8-9

Chapter 8: tests

8.5

Testing process

Write down the system component’s serial number, counter readings, test equipment numbers and revision numbers prior to starting the test. Go to the following menu item "Config ►Service ►System Information“: Selection „System information“

Display of system information Go to the menu item “Service ►Device ► Power Pic” or “Service ►Device ► Pics ► Power Pic” and write down the operation values. The serial numbers of the gas measurement are on the components themselves. Connect the system to the power and gas supplies. The device has to heat up 30 minutes, before you can start the device test. Inspection of the leonplus / leon must be carried out by following the individual testing steps presented in the following sections. Tests must be performed in the sequence presented. The test is completely finished once all the test steps on pages have been performed. The results of the individual tests must be recorded in the test log. Start-up of the device No recognition of malfunction CAUTION



Perform a system run-in (continous operation) for at least 48 hours.



Perform the final system test

Not calibrated oxygen and pressure sensors Oxygen and pressure measurement inaccurate ACHTUNG

8-10



Calibrate the oxygen an pressure sensors of your Flow-Analyzer

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

Chapter 8: Tests

8.6 8.6.1

General test items (visual inspection) visual inspection

First inspect the leonplus/leon visually. The device does not need to be powered on to conduct the visual inspection. Special testing equipment is not required. Be sure to cover the following: 

Condition of the housing ► Damage, cracks, etc?



Components: maneuvering handle, swivel arm, etc. ► securely attached?



Device labeling: Connection values, warnings ► Clean and legible?



Model plate ► Clean and legible?



Strain relief (mains) ► exist and usable?



Fuses (auxiliary outlets) ► existing and in order?



Filter on the cooling fan ► Installed and clean?



Screen ► No visible damage?



Condition of the keypadl ► No visible damage? Labeling legible?



Patient module ► lock and swivel arm intact?



Vaporizer holder (lock) ► function ensured?



High pressure manometer: ► Clean and legible? Any visible damage?



Rollers ► Easy to move? Parking brake? Seated securely?

Record the test results in the test log.

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

8-11

Chapter 8: tests

8.6.2

Internal visual inspection (tubing, cabling) Opening of the device while the mains plug is plugged in Danger of electrical shock

DANGER



Plug out the mains plug before opening the housing

Electrostatic discharges in the device

Risk of damage to the device  CAUTION

  

All work on the device must be done on a suitable earthed and conductive work surface (antistatic, ESD protection). Make sure that you are sufficiently earthed (e.g. 1 MΩ). Earth every instrument used during work on the ventilator Transport components and printed-circuit boards in the correct antistatic packages only.

Visually inspect the internal tubing and cabling in the leonplus/leon. First open the back panel on the device (see chapter "Maintenance"). The device does not need to be powered on to conduct the visual inspection. Special testing equipment is not required. Be sure to cover the following:



Tubing ► securely attached to connectors! Tubes pinched or otherwise damaged?



Cabling ► All plugs securely attached, no visible damage (crimps, defective insulation)



Batteries ► Securely seated, connections tight



Boards ► All boards securely installed?



Modules/components ► All modules and components securely installed?



Strap for back panel ► Present? Condition OK?

Record the test results in the test log!

8-12

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

Chapter 8: Tests

8.7

Testing gas supply Testing the gas supply requires that the preliminary pressures of the fresh gas blender are correctly set. (See the system calibration chapter).

8.7.1

Fresh gas system tightness leon plus

Go to the menu item: "Service ►Device ►Valves“:

Test setup:

Flow Analyzer Fresh gas valves Direct control

Inlet: Low Pressure

1

Docking station

Figure 4: Fresh gas system test

Blender tightness: 

Make sure that all fresh gas valves are closed and that the leonplus is connected to the gas supply.



Disconnect the water trap



Now, connect the fresh gas supply connection mandrel (1) with the Flow Analyzer’s pressure measurement inlet.



Lock the swivel arm



The measured pressure may increase by a maximum of 10 cmH2O within 30 seconds.

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

8-13

Chapter 8: tests

Faceplate tightness: 

Now, open one of the smallest fresh gas valves (valve 10 or 16) and wait until the pressure in the fresh gas branch climbs to 80-90 cmH2O.



Close all the fresh gas valves.



Make sure that the pressure after closing the valves falls to a maximum of 20 cmH2O within 30 seconds.

Vaporizer holder tightness:  . 

Insert a vaporizer into the left vaporizer holder.



Move the vaporizer from the left to the right vaporizer holder.



Repeat the tightness test for the faceplate with 80-90 cmH2O.

Repeat the tightness test for the faceplate with 80-90 cmH2O.

Fresh gas switchover test*: (* only for devices with external fresh gas outlet)

leonplus BAG

..Ext. FG/O2 INSP

EXP

1 Inlet: High Flow Value: O2%

Flow Analyzer

Figure 5: Fresh gas switchover test



Set up the test setup as shown above (connect connections for bag and expiration with a ventilation tube).



Generate a fresh gas flow of more than 4 l/min (e.g. by opening the fresh gas valve 8).



Move the switch for the external fresh gas outlet into the position “1”.



Make sure that the fresh gas flow is distributed at the outlet for external fresh gas.



Move the switch for the external fresh gas outlet into the position “0”.



Make sure that the fresh gas flow is distributed at the inspiration connection.

8-14

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

Chapter 8: Tests

External fresh gas outlet tightness: (* only for devices with external fresh gas outlet)

leonplus ..Ext. FG/O2 INSP

1

BAG EXP

Pressure sample line

Inlet: low pressure

FlowAnalyzer

Figure 6: Test setup external fresh gas outlet tightness



Set up the test setup as shown above



Open the external fresh gas outlet until the pressure rises up to 80 cmH2O.



Make sure that the pressure after closing the valves falls to a maximum of 20 cmH2O within 30 seconds.

Height check valves 

Make sure that all check valves of the vaporizers have the same height. Record the test results in the test log!

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

8-15

Chapter 8: tests

8.7.2

Fresh gas system tightness leon Tightness rotameter-block:

Tube (transparent) between rotameter block and vaporizer block

Connect to the low pressure Inlet

Inlet: low pressure



Pull off the connection tube between the rotameter block and the vaporizer block, directly at the vaporizer block



Connect this tube to the flow analyzer, Inlet low pressure



Make sure, that there is no fresh gas flow and the leon is connected to the gas supply



Make sure that the measured pressure climbs not more than 10 cmH2O within 30 seconds.

FlowAnalyzer

Figure 7: check fresh gas system

Fresh gas swivel arm tightness: Flow-Analyzer



Connect the fresh gas supply connection mandrel (1) with the Flow Analyzer’s pressure measurement inlet.



Disconnect the water trap



Now, set up a O2 fresh gas flow



Wait until the pressure in the fresh gas branch climbs to 80-90 cmH2O.



Close the fresh gas flow.



Make sure that the pressure after closing the valves falls to a maximum of 20 cmH2O within 30 seconds.

Inlet: low pressure

1

Figure 8: Tightness swivel arm leon

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Chapter 8: Tests

Vaporizer holder tightness: 

Insert a vaporizer into the left vaporizer holder.



Repeat the tightness test for the swivel arm with 80-90 cmH2O.



Move the vaporizer from the left to the right vaporizer holder.



Repeat the tightness test for the swivel arm with 80-90 cmH2O.

Fresh gas switchover test*: (* only for devices with external fresh gas outlet)

leon BAG

..Ext. FG INSP

EXP

1 Inlet: High Flow Value: O2%

Flow Analyzer

Figure 9: Fresh gas switchover test



Set up the test setup as shown above (connect connections for bag and expiration with a ventilation tube).



Generate a fresh gas flow of more than 4l/min.



Move the switch for the external fresh gas outlet into the position “1”.



Make sure that the fresh gas flow is distributed at the outlet for external fresh gas.



Move the switch for the external fresh gas outlet into the position “0”.



Make sure that the fresh gas flow is distributed at the inspiration connection.

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8-17

Chapter 8: tests

External fresh gas outlet tightness: (* only for devices with external fresh gas outlet)

leon ..Ext. FG/O2 INSP

BAG EXP

Pressure measurement tube

1

Inlet: low pressure

FlowAnalyzer

Figure 10: Test setup external fresh gas outlet tightness



Set up the test setup as shown above



Open the external fresh gas outlet until the pressure rises up to 80cmH2O.



Make sure that the pressure after closing the valves falls to a maximum of 20 cmH2O within 30 seconds.

Height check valves 

Make sure that all check valves of the vaporizers have the same height. Record the test results in the test log!

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Chapter 8: Tests

8.7.3

Drive gas generator tightness

Test setup:

Drive gas valves Direct control 1

Flow-Analyzer Eingang: Low Pressure Figure 11: Drive gas generator tightness



Open the rear panel (see chapter „Maintenance“) and pull off the connection tube (1) directly at the drive gas generator



Connect the drive gas generator outlet connection to the Flow Analyzer inlet, using an appropriate tube.

Generator tightness 0 cmH2O: 

Make sure that all drive gas valves are closed and that the leonplus/leon is connected to the gas supply.



The measured pressure may increase by a maximum of 10 cmH2O within 30 seconds.

Generator tightness 80 cmH2O: 

Now, open the smallest drive gas valve and wait until the pressure in the fresh gas branch climbs to 80-90 cmH2O.



Close all the fresh gas valves.



Make sure that the pressure after closing the valves falls to a maximum of 20 cmH2O within 30 seconds.

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Chapter 8: tests

8.7.4

Swivel arm/Docking tightness



Connect the mandrel Auto/Man (1) with the Flow Analyzer’s pressure measurement inlet and write down the measured pressure



Navigate to the menu point “Service ► Device ► Valves” and press “Auto/Man”.



Cut the AIR supply (central gas supply).



The pressure may not fall or climb more than 100 cmH2O within 100 sec.



Repeat the tightness test for the mandrel open system (2).



Repeat the tightness test for the mandrel excess diaphragm (3).

Auto/Man Open System excess diaphragm switch

Flow-Analyzer Inlet: Low Pressure

1

2 3 Figure 12: Swivel arm/Docking tightness

Record the results in the test log!

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Chapter 8: Tests

8.7.5

Drive gas switchover test

O2/AIR failure test: Preliminary steps/test setup:

leonplus / leon EXT FG / O2 INSP

22mm breathing tube

BAG EXP

Breathing bag for manual ventilation

Settings: Test lung

C = Compliance: 10, 20 RP = Resistance: 20, 50

Figure 13: Drive gas switchover test (test setup)

Procedure: 

Initiate any form of ventilation (automatic ventilation).



Cut the O2 supply (central gas supply) and wait until the displayed O2 inlet pressure reaches 0. The automatic ventilation must continue uninterrupted.



Reinstate the O2 supply (central gas supply).



Cut the AIR supply (central gas supply) and wait until the displayed AIR inlet pressure reaches 0. The automatic ventilation must continue uninterrupted.



Reinstate the AIR supply (central gas supply).

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Chapter 8: tests

O2 test fresh gas branch Test setup for devices with fresh gas outlet: Prepare the following test setup:

1

2

leonplus / leon ..Ext. FG/O2

2

?

INSP

BAG EXP

Inlet: High Flow Value: O2%

Flow Analyzer

3 2

Figure 14: O2 test fresh gas branch (test setup)

If the device does not offer an external fresh gas resp. O2 outlet the testing has to be done by the fresh gas port on the swivel arm. See test setup in Figure 1 Test setup for calibration of fresh gas flow monitor. Procedure: 

Connect the test setup to the external fresh gas or O2 outlet (2).



If the device has an external fresh gas outlet, the switch (1) has to be in the position “1”. Then, navigate to the menu item “Service ►Device ►Valves” (see Figure 15, page 8-23) and open the fresh gas valve 1 (4.5 l/min O2) or set up a fresh gas flow of 4.5 l/min O2 by the rotameter block.



If the device has an external O2 outlet, leave all fresh gas valves closed. Instead set a flow of 5 l/min O2 at the flow meter (3).

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Chapter 8: Tests

4.5l O2

Inactive = Drive gas AIR

Figure 15: O2 test fresh gas branch (screen)



Now, press the button for the drive gas switchover 20x every second.

Expected reaction: 

The O2 contents in the fresh gas may decrease for a short time during switchover.



The value must stabilize at 100% O2 not later than 120 seconds after the last switchover.

Record the test results in the test log!

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Chapter 8: tests

8.7.6

Tightness test in high pressure range*

(* if high pressure connections are available) Opening the reserve gas cylinders too quickly Danger of explosion CAUTION



Open the valves of the reserve gas cylinders slowly and carefully

Preliminary steps: Ensure that the device is not in any ventilation mode and the O2 emergency dosing is closed. Connect the two reserve gas cylinders (N2O/O2) with the high pressure connections (A) of the leonplus / leon. Make sure that both bottles indicate the following fill pressures: 

N2O ≥ 45 kPa x 100 (bar)



O2 ≥ 80 kPa x 100 (bar)

Carefully open the valves of both bottles!

A

Procedure: B

Check the display of both high pressure manometers (B). Now close the valves on both gas cylinders. Record the pressure values displayed immediately after closing the valves. Wait 5 minutes and record both values again. Make sure that neither manometer display has changed. 1 kPa x 100 (bar)

Figure 16: Tightness test in high pressure range

Record the results in the test log!

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Chapter 8: Tests

8.7.7

Reserve gas/Drive gas switchover*

(* if reserve gas connections are available) Preliminary steps: 

Make sure that the leonplus/leon is connected to the central gas supply.



Make sure that the O2 reserve gas cylinders are connected and opened.

Test setup:

leonplus / leon EXT FG / O2 INSP

BAG EXP

Breathing bag for manual ventilation

Test lung

Figure 17: Reserve gas switchover test (test setup)

Procedure: 

Initiate any automatic ventilation.



Notice the supply pressure by pressing the button “alarm limits”



Remove the gas connection hose for AIR from the central gas supply: Reaction: o o o

The automatic ventilation must continue uninterrupted. The message “Drive gas switched to O2” appears shortly. The central gas supply from AIR drops: Pressure decreases, but does not have to reach 0

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Chapter 8: tests



In addition, remove the supply line for AIR from the central gas supply now: Reaction: o o o



The automatic ventilation is stopped: Only “Man/Spont” possible. The fresh gas supply is now supplied by the reserve gas cylinders. The central gas supply pressure from AIR may not increase without connecting the central gas supply.

Check if the manual ventilation bag is filled with fresh gas und the pressure set on the APL is reached. Record the results in the test log!

Disconnection of the reserve gas cylinders: 

Disconnect the gas connection hose O2 from the central gas supply



Close the valve of the O2 Reserve gas cylinder



Eliminate O2 from the system by opening the external O2 outlet for example



The reserve gas cylinder can be removed if the O2 high pressure manometer is zero



Remove the N2O reserve gas cylinder according to this procedure

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Chapter 8: Tests

8.7.8

Testing the drive gas generator

The drive gas for the bellows is generated by a 12-valve valve group. Set up the test as follows to check the function of each valve: Testing drive gas valves Danger of inaccurate measurement   CAUTION 

Use a tube with a smooth inner wall to prevent flow resistance. Do not use an adapter if at all possible. Instead, use a tube (e.g.: Item No. T06001019) that has the required connector sleeve (10/19mm). Make sure that the pressure of the gas supply equals at least 2.8 kPa x 100 (bar).

Preliminary steps: Open the rear panel of the device (see chapter “Maintenance”)

2

3

Pull off the connection tube (1) between the drive gas generator (2) and the plateau valve (3) (not visible here) directly at the drive gas generator (2). Connect the drive gas generator outlet connection to the Flow Analyzer inlet, using an appropriate tube.

1

Figure 18: Testing the drive gas generator (preliminary steps)

Test setup: 10 mm connection

Drive gas generator (2)

Flow Analyzer

Drive gas tube e.g.: T06001019

22 mm connection

Inlet: High Flow Gas type: 0/1013 Air

Figure 19: Testing the drive gas generator (test setup)

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Chapter 8: tests

Procedure: 

Log into the Service menu.

Go to the menu item: "Service ►Device ►Valves“:

Direct control valves.

of

control

1

Direct control of drive gas valves.

Figure 20: Direct control of drive gas valves and control valves



Select drive gas AIR (button 1, disabled).



Notice the drive gas pressure under “Service ► Device ► Monitor Pic“, Supply pressure or “Service ► Device ► Pics ► Monitor Pic“, Supply pressure



Using the buttons, set the valve throughput according to the following table.



In each case, make sure that only the valve being tested is open.



All other drive gas valves must be closed.



The valves 5, 4 and 3 can only be measured in Low-Flow Inlet of the Flow Analyzer Note that the target values in the table are valid for a supply pressure of 4.0 kPa x 100 (bar). A different supply pressure changes the flow accordingly. For this reason, only the minimum flow rate for a pressure of 2.8 kPa x 100 (bar) is checked.

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Chapter 8: Tests

Specifications: Valve

Target value at 4.0 kPa x 100 (bar) 0.07 l/min 0.15 l/min 0.3 l/min 0.6 l/min 40 l/min 20 l/min 10 l/min 5 l/min 2.5 l/min 1.25 l/min 40 l/min 40 l/min

5 4 3 2 13 12 11 10 9 8 7 6

Allowable min. 0.04 l/min 0.09 l/min 0.19 l/min 0.38 l/min 25.20 l/min 12.60 l/min 6.30 l/min 3.15 l/min 1.58 l/min 0.79 l/min 25.20 l/min 25.20 l/min

Table 1: Test parameters for drive gas valves

Record the test results in the test log. Ending the testing of the drive gas valves Danger of device failure CAUTION



Reconnect the tube between the drive gas generator and the plateau valve

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Chapter 8: tests

8.7.9

Fresh gas valve test (only leonplus) Incorrectly dosed fresh gas Life-threatening situation to a patient

DANGER



Exercise extreme care when conducting this test.

Test setup: Set up the test for the flow measurement (see 8.3, page 8-7). Procedure: 

Go to the menu item: "Service ►Device ►Valves“:

Direct control of the fresh gas valves.

Inactive = Carrier gas AIR

Figure 21: Direct control of the fresh gas valves



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Use the buttons to connect through the valves one at a time. In each case, make sure that only the valve being tested is open. (Carrier gas: AIR)

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Chapter 8: Tests

Valve 2/8 1/23 0/22 15/21 14/20 13/19 12/18 11/17 10/16

Target value 9 l/min 4.5 l/min 2.25 l/min 1.12 l/min 0.56 l/min 0.28 l/min 0.14 l/min 0.07 l/min 0.035 l/min

Specification ≥ 9.0 l/min ≥ 4.5 l/min ≥ 2.25 l/min ≥ 1.12 l/min ≥ 0.56 l/min ≥ 0.28 l/min ≥ 0.14 l/min ≥ 0.05 l/min ≥ 0.03 l/min

Table 2: Fresh gas blender test

Make sure to measure the flow values with the correct gas type settings at the Flow Analyzer (O2 man. 100% 0/1013 or AIR 0/1013). Record the results in the test log.

8.7.10

Test of rotameter block

Carrier gas AIR

oxygen Carrier gas N2O

switch AIR / N2O

Figure 22: Rotameter block test

Switch AIR / N2O: 

Switch carrier gas to AIR Expected reaction: o Only carrier gas AIR could be applied o Carrier gas N2O could not be applied (falls directly back to zero)



Switch carrier gas to N2O Expected reaction: o Only carrier gas N2O could be applied o Carrier gas AIR could not be applied (falls directly back to zero)

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Chapter 8: tests

Fresh gas dosing N2O: 

Set up a fresh gas dose of 2 l/min N2O Expected reaction: o Fresh gas is a mixture of N2O and O2 o Fresh gas contains approximately 1 l/min O2

Break down CGS O2 (Nitrous oxide cut-off) 

Pull the O2 connection hose out of the wall supply. Expected reaction: o O2 and N2O falls back to zero o N2O reaches zero first

Gas type check:   

Set up the test setup for flow monitor/calibration (see chapter 8.3 , page 8-7) Measure the oxygen concentration with the flow analyzer (Inlet High Flow) Dose 3 l/min N2O and 3 l/min O2 Expected reaction: o The oxygen concentration of the fresh gas is approximately 50%

Lateral load spindle:  

Setup the O2-spindle to 1 l/min Load the spindle lateral (press and pull) Expected reaction: o The flow may not increase or decrease more than 0.3 l/min due to the load

 

Repeat the test for the N2O-spindle Repeat the test for the AIR-spindle

Test ratio system:   

Set up the test setup for flow monitor / calibration (see chapter 8.3 , page 8-7) Measure the oxygen concentration with the flow analyzer (Inlet High Flow) Set up the following fresh gas setting by setting up the N2O-spindle Expected reaction: o The oxygen concentration of the fresh gas is between 21 % and 29 %

Testing ratio system Specification Fresh gas dose O2 0,25 l/min* 21 % - 29 % Fresh gas dose O2 1,0 l/min* 21 % - 29 % Fresh gas dose O2 2,0 l/min* 21 % - 29 % (* set up the fresh gas dose O2 by setting up the N2O-spindle) Table3: Testing ratio system

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Chapter 8: Tests

Testing rotameter:   

Set up the test setup for flow monitor/calibration (see chapter 8.3 , page 8-7) Measure with the flow analyzer, Inlet low flow, corresponding gas type, 0/1013 Set up the fresh gas flow according to the following table and measure the delivered fresh gas flow

Test item rotameter Fresh gas dose O2 1 l/min Fresh gas dose O2 3 l/min Fresh gas dose O2 6 l/min Fresh gas dose AIR 1 l/min Fresh gas dose AIR 3 l/min Fresh gas dose AIR 6 l/min

specification 0.85 – 1.15 l/min 2.7 – 3.3 l/min 5.4 – 6.6 l/min 0.85 – 1.15 l/min 2.7 – 3.3 l/min 5.4 – 6.6 l/min

Table 4: Settings testing rotameter

8.7.11

Testing option panel*

(*falls vorhanden) Check the tubing emergency dosing and additional flow meter 

Open the additional flow meter (Ext. O2-Outlet or Fresh gas Outlet)



Make sure that O2 respectively fresh gas is distributed at the additional flow meter



Open the emergency dosing



Make sure that no O2 is distributed at the inspiration connection.



Navigate to the menu item “Service ► Device ► Valves” and open the emergency dosing



Make sure that O2 is distributed at the inspiration connection

switch emergency dosing

Figure 23: Switch emergency dosing

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Chapter 8: tests

8.8

Test of hardware calibration

Go to the menu item: “Service ►Device ► Monitor Pic” or “Service ►Device ►Pics ► Monitor Pic 1 or Monitor Pic 2”: Drive gas inlet pressure (Air or O2 depending on the device configuration)

DRM1

Fresh gas flow

DRM3 + DRM4

Figure 24: Testing system calibration hardware

Inlet drive gas pressure: Write down the inlet pressure of the gas generator (Air or O2) depending on the device configuration. (Standard: Air) DRM1/2 ADC:

Write down the DRM1/2 value.

DRM3 ADC: (at 0 cmH2O)

Write down the DRM3 value at a pressure of 0 cmH2O (see 8.4 Test setup for pressure monitor/calibration, page 8-8)

DRM3 ADC: (at 60 cmH2O)

Write down the DRM3 value at a pressure of 60 cmH2O (see 8.4 Test setup for pressure monitor/calibration, page 8-8)

DRM4 ADC: (only leonplus)

Make sure that all fresh gas valves are closed and the emergency dosing is turned off. (Fresh gas flow 0 l/min) Then, write down the DRM4 value.

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Chapter 8: Tests

Blender fresh gas flow: (only leonplus)

Voltage heater socket

Open all fresh gas valves for Air. Measure the fresh gas flow with the Flow Analyzer (see 8.3 Test setup for flow monitor/calibration, page 8-7). Make sure that the value Blender Fresh Gas Flow maximum 2l/min is different from the Flow Analyzer’s indication. Measure the voltage at the heater connector on the swivel arm. Heater connector

Figure 25: Test setup voltage heater connector

You can use the heater connector (see 8.2 Required tools and testing equipment , page 8-6).

Connect a cable to those both inner contacts of the heater connector

Your measurement cable will look like this, for example

Figure 26: Cable for voltage measurement

Measure the voltage between both wires of the measurement cable.

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Chapter 8: tests

Voltage battery

Turn off the device and measure the voltage between pin 1 and pin 3 on the Controller board at the NetDCU.

Pin 1

Pin 3

Figure 27: Voltage battery

Loudspeaker/alarm transmitter

The leonplus/leon is equipped with two acoustic signal emitters to alert the user to possible error and critical situations. Next to the loudspeaker on the back of the controller board, there is an additional alarm transmitter on the adapter board. Turn on the device and check that the alarm transmitter during switch-on and the loudspeaker during self test perform a signal.

Compare all listed measurements in the test log and ensure that the values are within tolerance. If individual values deviate, calibration of the respective might be necessary. Follow the respective guidelines in the chapter “Calibration”.

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Chapter 8: Tests

8.9

Fresh gas blender total flow test (only leonplus)

The fresh gas blender test ensures that the mix ratios generated are within allowable tolerances! Incorrectly dosed fresh gas Life-threatening situation to a patient DANGER



Exercise extreme care when conducting this test



Close the rear panel of the housing before starting this test



Retain the flow measurement test setup (see 8.3 Test setup for flow monitor/calibration, page 8-7)



Switch to the ventilation screen and start manual ventilation. (CAUTION: In order to start ventilation, the patient module’s control switch (1) must be pressed)

1

Control switch patient module



Meter 9 l/min O2 Measure the gas type O2 man 100% 0/1013. For the set fresh gas dosing, the delivered, measured flow must be between 8.9 and 9.5 l/min.

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Chapter 8: tests



Meter 9 l/min AIR (21% O2) Measure the gas type AIR 0/1013. For the set fresh gas dosing, the delivered, measured flow must be between 8.9 and 9.5 l/min.



Meter 9 l/min mixture: O2 with nitrous oxide at 25% O2 Measure the gas type AIR 0/1013. For the set fresh gas dosing, the delivered, measured flow must be between .7.9 and 8.5 l/min. (only for devices with nitrous oxide option)

Record the results in the test log!

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Chapter 8: Tests

8.10

Test of Software calibration

Date/Time: Go to the menu item “Config” First, check the date and time settings. Correct possible deviations. Brightness Display: Change the brightness of the display and check the change. Zero point calibration test: Go to the menu item: “Service ►Service ►Flow calibration”: 1

2 1 1

Figure 28: Zero point calibration flow sensor

3

Procedure: To ensure that there is no gas flow in the sensors during calibration, the procedure needs to be performed with the patient module opened. 4

To start the zero point calibration, select "Zero point ► Calibrate". Follow the instructions on the screen. If the message "Flow not 0" appears (dialog 4), the device attempts another calibration (starting with dialog 2). If the zero calibration fails again, the entire procedure needs to be repeated. Error and warning messages are highlighted in yellow.

5

The message "Done" appears after the calibration completes successfully (dialog 5). Note Flow 0 ADC and Flow 1 ADC in the test log. Dialogs

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Chapter 8: tests

In the screen "Flow calibration" (Figure 28) the date of the last calibration is now displayed under "Zero Point". Flow direction check: Select Zero point calibration of Flow Sensors again. Connect the outlet BAG to the outlet ext. FG/O2. If the device does not offer an external fresh gas resp. O2 outlet the BAG connection has to be short circuited by the test adapter of the patient module. Therefore the tube including connection adapter of the breathing bag has to be plugged on the test adapter. See test setup in Figure 3: Alternative test setup pressure monitor

Generate a gas flow from the outside into the patient module’s inspiration port: The red bar (inspiration) has to spike, while the blue bar has to stay in position.

leon plus / leon Ext. FG / O2 INSP

BAG

Generate a gas flow from the outside into the patient module’s expiration port: Both bars have to spike.

EXSP

Leave the calibration dialog and press the “Cancel” (2) button. 2 Figure 29: Flow direction check

Correction factor flow measurement: Write down the correction factor Insp. and Exsp. (1) (see Figure 28, page 8-39).

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Chapter 8: Tests

FiO2 (ADC 21% calib.)*:

(*only for devices with FiO2 measurement cell)

The FiO2 calibration is the calibration of the KE25 oxygen cell on the insp. inspection class on the patient module.

Go to the following menu item: “Service ►Calibration“:

1

2

3 Figure 30: FiO2 (ADC 21% calib.)

Write down the ADC Wert (3), shown at the end of the 21% calibration. Repeat this procedure until you get a stable reading for the ADC-Value.

3

Dialogs

Fresh gas O2 (ADC 21% calib.) (only leonplus): The Fresh gas O2 calibration is the calibration of the oxygen cell on the generator module. The fresh gas O2 calibration is identical with the FiO2 calibration process.

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Chapter 8: tests

Pressure sensor calibration 0 and 60 cmH2O: Go to the following menu item: “Service ►Calibration“: Make sure that the airway pressure is 0 cmH2O (see 8.4 Test setup for pressure monitor/calibration, page 8-8) Carry out the calibration of the pressure sensor (4). 4 5

Create a pressure of 60 cmH2O (see 8.4 Test setup for pressure monitor/calibration, page 8-8). Carry out the 60 cmH2O calibration of the pressure sensor (5).

Figure 31: Software calibration pressure sensors.

Pressure sensor calibration Danger of inaccurate measurement CAUTION

8-42



Perform always a test of the airway pressure measurement after the pressure sensor calibration (see 8.16 Testing airway pressure measurement)

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Chapter 8: Tests

Touch screen calibration: In the Advanced Service menu, select "Touchscreen ►Calibrate Touchscreen".

6

Figure 32: Testing the touchscreen

Procedure: Press the "Calibrate touchscreen" button to start the calibration. Use your finger to conduct the test (rather than a PDA stylus or other tool.) Press all the crosshairs in the sequence displayed. Hold your finger on the surface until the next crosshair is displayed. When the calibration is finished, you will be prompted to exit it and press the "ESC" button. Therefore simply click anywhere on the touch surface. TouchScreen calibration Gefahr von Geräteschäden CAUTION



If you have done the TouchScreen calibration perform a testing of the TouchScreen (8.13.5 Testing the touchscreen)

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Chapter 8: tests

8.11

Testing the batteries

Go to the following menu item: “Service ► Device ► PowerPic“ or “Service ► Device ► Pics ► PowerPic1“

Battery 1 values

Battery 2 values

Figure 33: Testing the batteries

Write down the voltage and capacity data for both batteries. The batteries’ capacity has to be at least 50%.

Record the test results in the test log!

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Chapter 8: Tests

8.12

Testing the operating modes

This test ensures that the operating modes are detected accurately (mains/battery operation) and that there is adequate run-time in battery mode. Turn the device on in mains operation and run a system test. (See operating instructions or follow directions on the screen). Then set up the test as follows: Test setup:

leonplus / leon Ext. FG/O2

22mm Breathing Tube

BAG

INSP

EXP

Breathing bag for manual ventilation

Settings: C = Compliance: 10, 20

Test lung

RP = Resistance: 20, 50 Figure 34: Testing the operating modes

Procedure: Switch to PCV (Adult) ventilation mode and set the following parameters: Parameter

Setting

Mode

PCV

Freq.

30

I:E

1:2

Plateau

50%

PINSP

50 cmH2O

Table 5: Settings testing operating modes

Make sure that the device is in mains operation and start ventilation.

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Chapter 8: tests

Operating mode:

Display:

Mains operation: 

Verify that mains operation is displayed.



Pull out the mains plug. (The device must continue to run without interruption)

Battery operation: 

Verify that battery operation is displayed.



Run the device for 30 minutes in battery mode.



Make sure that after 30 minutes the display indicates that another 30 minutes operating time remain (the time remaining cannot be adjusted downward on the device).

Disconnection of the battery plug Danger of severe damage CAUTION



Pull out the battery plug only if you intend to replace the battery

If the battery is disconnected, the battery management of the leon(plus) assumes that the battery has been replaced and starts automatic detection of the battery capacity. Therefore, it takes several hours for the charge to display correctly after a battery is connected.

Record the test results in the test log.

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Chapter 8: Tests

8.13

Testing the electronic control and display elements

The testing functions of the advanced Service menu are used for testing the electronic control elements (touchscreen and keypad).

Starting the Advanced Service (Fab Test) menu: 1. Turn off the device 2. Make sure that the device is connected to the mains voltage. 3. Press the “On/Off” hard key and keep it pressed until the following screen appears.

Figure 35: Starting the advance service menu (Fab Test)

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Chapter 8: tests

8.13.1

Keypad test

In the Advanced Service menu, select "Keypad".

Activate the test by turning the dial by one notch to the left. Figure 36: Advanced Service menu: Keypad

When the keypad test is enabled, the title bar appears in a blue background on the screen. Each hard key on the keypad has a corresponding control field on the screen. When you press a hard key on the keypad, the corresponding control field on the screen should react (change to green, look like a pressed button).

Figure 37: Keypad test

The control fields on the screen are arranged exactly like the buttons on the keypad.

The wheel also has a pushbutton function! The control field at the bottom right corresponds to the wheel. Check all the buttons on the control panel. The results of the individual tests must be recorded in the test log. If one or more buttons fails, verify that the panel cable is properly positioned in the terminal block of the controller board. The keypad itself may need replacing.

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Chapter 8: Tests

8.13.2

Display test

The TFT display of the leonplus/leon has a pixel reliability of 99.999%. At a physical resolution of 1024x768 (786,432 pixels), 2,359,296 dots are required for display (786,432 pixels x 3 basic colors). This level of reliability guarantees the function of 99.999% of the total 2,359,296 dots. Only 23 dots maximum may fail (total of failed red, green, and blue dots). During the display test, the display is filled completely with the three basic colors: red, green, and blue. This pattern allows defective dots to be seen easily. Three other screens also enable you to evaluate the extent to which any failed pixels have on the overall display.

Pixel defects: Select in the Advanced Service menu, "Display ►All Tests".

Gradient: White: Black: Don not write down pixel defects.

Figure 38 : Display test

Procedure: Go through the screens shown on the right sequentially. Only the pixel defects on the last three screens are counted and totaled (red, green, blue).

Red: Write down pixel defects Green: Write down pixel defects Blue: Write down pixel defects Test screens

Add up the number of defective pixels; the total must be less than 24. The results of the individual tests must be recorded in the test log! In addition to the automatic test cycle, the test screens can also be launched individually.

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Chapter 8: tests

Turning off the display: In the Advanced Service menu, select "Display ►Display Off". Hold the button “Display Off” pressed and ensure that the display is turned off. Loosen the button will turn the display on again.

Figure 39: Turning off the display

Record the results in the test log.

8.13.3

LED test

The LEDs are located in the keypadl of the leonplus. They indicate various operating states and provide optical alarms. The LED tests are used to verify the function of each LED. The leon has only one LED to show the main supply. In the Advanced Service menu, select "LED ►Sequence Test". Sequence test:

1: 2: 3: 4: 5:

Figure 40: LED test

Procedure: Press the "Sequence Test" button to start the test sequence. The LEDs light in the sequence shown on the right.

6:

The mains voltage LED is lit continually as long as the device is connected to the mains voltage.

8:

7:

The battery, alarms, and alarm mute LEDs can be also be controlled individually using the corresponding buttons. Check the function of all the LEDs and enter the test results in the test log! 8-50

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Chapter 8: Tests

8.13.4

Sound test

The leonplus/leon is equipped with two acoustic signal emitters to alert the user to possible error and critical situations. Next to the loudspeaker on the back of the controller board, there is an additional alarm transmitter on the adapter board. In particular, the alarm transmitter is not active during normal operation of the device and sounds only during hardware complications.

In the Advanced Service menu, select "Sound/Mic ►Loudspeaker and microphone test":

Loudspeaker test

Signal emitter test

Figure 41: Sound test

Procedure: Press the "Loudspeaker and microphone test" button to start the sound test. One after the other, the loudspeaker (controller board) and the alarm transmitter (adapter board) are activated. Make sure that both signal emitters are functioning properly. Record the results of the individual tests in the test log!

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Chapter 8: tests

8.13.5

Testing the touchscreen

The leonplus/leon is equipped with a touchscreen to make operating easy and comfortable. The function of the touchscreen depends mainly on the calibration.

In the Advanced Service menu, select "Touchscreen ►Test Touchscreen".

Figure 42: Testing the touchscreen

Procedure: Press the "Test touchscreen" button to start the touchscreen test. A white screen is displayed and a red crosshair appears as soon as the touchscreen registers a touch. Use your finger to conduct the test (rather than a PDA stylus or other tool.). Make sure that the touchscreen is functioning properly. Pay special attention to the corner areas and ensure that the point of contact has been accurately detected. Turn the wheel to end the test. Record the test results in the test log! If there are deviations between the point of contact and crosshair displayed, you need to calibrate the touchscreen (see 8.10 Test of Software calibration, page 8-39).

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Chapter 8: Tests

8.14

Testing the mechanical control and display elements

8.14.1

Testing the O2 emergency dosing (only leonplus)

Emergency dosing is used to set O2 emergency dosing manually. It enables the patient to be supplied with oxygen in the event the blender fails or the device electronics fail completely. Preliminary steps: Make sure that the leonplus is connected to the central gas supply. Connect the bag connector (1) to the flow analyzers inlet. Connect the connectors Insp. (2) and Exp. (3) with each other.

3

1 2 Figure 43: Testing O2 emergency dosing (connections)

Test setup:

22mm breathing tube

leonplus ..Ext. FG/O2 INSP

Flow Analyzer

BAG EXP

Inlet: Low Flow Gas type: O2 man. 100%, 0/1013

Figure 44: Testing O2 emergency dosing (test setup)

The emergency dosing is only active when the device is turned off or when it is activated in the service mode explicitly.

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Chapter 8: tests

Procedure: Set the displayed flow values using the emergency dosing grid flow meter (1) and check the flow for each setting at the bag connection. Make sure the dispensed gas is oxygen.

1

Check all values listed in the table below and make sure that the measured value lies in the permissable range.

Figure 45: Position of the O2 emergency dosing

Press the Flush button (2). Make sure the dispensed gas is oxygen. 2

Figure 46: Flush button position

Flow setting 4 l/min 10 l/min 15 l/min Flush button O2-% at emergency dosing & flush

Allowable min. 3 l/min 8 l/min 12 l/min 32 l/min 90%

Allowable max. 12 l/min 18 l/min 50 l/min

Table 6: O2 emergency dosing testing parameters

Record the results of the tests in the test log!

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Chapter 8: Tests

8.14.2

Testing the Flush (Bypassflow) (only leon) Press the Flush button (2). Make sure the dispensed gas is oxygen. 1

Measurement: Flow analyzer inlet High-Flow Gas type: O2-man, 100%, 0/1013

Figure 47: Position der Flush-Taste

Flow-setting Flush-button O2-% Flush

Minimum 32 l/min 90%

Maximum 50 l/min

Table 7: testing the Flush-button

8.14.3

Testing O2 auxiliary flow meter (optional)

(Only for devices with auxiliary flow meter) If the leonplus/leon contains an additional O2 flow meter instead of the fresh gas switch, it has to be checked according to the table below. Connect the outlet O2 auxiliary flow meter directly to the flow analyzer. 1

Check all values listed in the table below and make sure that the measured values lie within the permissible range.

Figure 48: Position of the O2 auxiliary flow meter

Measurement: Flow analyzer inlet Low-Flow, High-Flow Gas type: O2-man, 100%, 0/1013 Make sure the dispensed gas is oxygen. Flow setting 4 l/min 9 l/min 15 l/min O2-% at auxiliary flow meter

Permissible min. 3 l/min 7 l/min 12 l/min 90%

Permissible max. 11 l/min 18 l/min

Table 8: O2 auxiliary flow meter testing parameters

Record the results of the tests in the test log! Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

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Chapter 8: tests

8.14.4

Vacuum injector and vacuum meter test*

(if available) Preliminary steps: Attach the connection for the extraction device (1) to the suction head. Make sure that the float moves freely and is working. Make sure that the float falls back to its starting position. Close the suction connection in the suction head cover.

1

Figure 49: Vacuum injector connection

Procedure: Position the vacuum switch (1) to "On" (right stop). Use the vacuum dosing (2) to set the values in the following table. Check the display of the vacuum meter (3). Enter the test results in the test log.

4

2

3

Figure 50: Vacuum dosing

Also check the switch (2) by activating it with the vacuum meter at the end-scale value.

VAC display (setting via VAC dosing) 0 bar (turn right to full stop) Maximum (turn completely to the left) Vacuum switch (function)

Specification 0 bar  - 0.75 bar

Table 9: Vacuum injector and vacuum meter test parameters

You must be able to set the vaccum to 0 by turning the dosing button (turn completely to the right).

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Chapter 8: Tests

8.15

Control switch test

The leonplus/leon has control switches for detecting the current operating state of the device. The control switches are tested in the ventilation screen (standby). It is not necessary to start ventilation.

Preliminary steps: 

Switch to the ventilation screen

Display range for alarming and failures

Figure 51: Control switch test

Test the control switches function according to the following sections. Make sure the expected reaction is displayed in the leonplus/leon alarm window.

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Chapter 8: tests

8.15.1

Ext. fresh gas control switch (if applicable)

A software control switch monitors the position of the switch on fresh gas outlet.

Procedure: Test the switch’s function as follows:

Switch to Position „1“: The Message „S: ext. fresh gas aktive“ appears. Switch to Position „0“: The Message „S: ext. fresh gas aktive“ expires.

Figure 52: External fresh gas control switch

Record the test results in the test log!

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Chapter 8: Tests

8.15.2

Patient module control switch

A software control switch monitors the position of the patient module.

Procedure: Test the switch’s function as follows: Open the patient module: The Message „S: patient module open“ appears. Close the patient module, or press the control switch manually. The Message S: patient modul open “ expires.

Figure 53: Patient module control switch

Record the test results in the test log!

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Chapter 8: tests

8.15.3

Absorber control switch

A software control switch monitors the absorber and allows for early detection of system operation without the absorber with output of a corresponding error message.

Procedure: Test the switch’s function as follows:

Separate the absorber from the patient module The Message „Absorber removed. Circle system shortcircuited“ appears. Reconnect the absorber cylinder to the patient module The message „Absorber removed. Circle system shortcircuited“ expires.

unlock

Figure 54: Absorber control switch

Record the test results in the test log!

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Chapter 8: Tests

8.15.4

Bellow sensor *

(* if applicable) Check the function of the bellow sensor. Therefore start ventilation with the following settings: Parameter

Settings

Fresh gas flow

0,20l/min

Mode

PCV

Freq.

20

I:E

1:1

Plateau

50%

PINSP

40 cmH2O

PEEP

5 cm H2O

Table 10: Settings for testing fresh gas alarm



After a few breathings, the bellow starts to “climb up”



The alarming ● freshgas shortage appears



The bellow falls down if you choose a higher fresh gas flow



The alarming expires

Record the results in the test log! If the bellow sensor does not behave as expected, a calibration is needed (see chapter 7 calibration).

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8.16

Testing airway pressure measurement

Procedure: 

Set up test setup for pressure measurement (see chapter 8.4, page 8-8)!



Log into the “Service Mode”.

Go to the menu item: "Service ►Device ►Valves“ (leonplus)

Set the Fresh gas Flow to a value between 4,5 and 9 l/min: Attention: Make sure that all control valves are inactive!

Figure 55: Direct control of the control valves

Resp. set up a fresh gas flow of 4,5 – 9,0 l/min by the AIR-spindle (leon). Go to the following menu item "Service ►Device ►Flow board“:

Direct display of the airway pressure measurement.

Figure 56: Direct display of airway pressure

Adjust the pressure values listed in the table below using the APL valve. Set the values so the reference value is displayed in the Flow Analyzer display. The dial on the APL valve is not relevant for this test. Make sure that the values displayed on the leonplus/leon are within allowable tolerances. Manometer 10 cmH2O 20 cmH2O 30 cmH2O 70 cmH2O

Paw value leon(plus)

Allowable min. 9 cmH2O 19 cmH2O 28 cmH2O 67 cmH2O

Allowable max. 11 cmH2O 21 cmH2O 32 cmH2O 73 cmH2O

Table 11: Test parameters for airway pressure measurement

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Chapter 8: Tests

8.17

Gas measurement test (SERVOMEX/OXIMA/AION/IRMA)*

(* if applicable)

To test the multi gas analyzer, you need a calibration bottle as specified in 8.2 (Required tools and testing equipment). The testing procedure for multi gas analyzer is for the most parts identical using SERVOMEX and OXIMA sensors. Perform a calibration of the multi gas analyzer only if the accuracy test failed and the readings are out of tolerance. 

Stop the ventilation.



Log into the Service menu.

Go to the following menu item "Service ►Artema AION ► Calibration“:

Figure 57: Artema AION service menu

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Chapter 8: tests

The measurement accuracy for AION sidestream gas monitoring follow: "Full Accuracy – Mode" measurement accuracy specification Type of gas

Concentration [%REL]

Permissable deviation [%ABS]

Interference [%ABS]

CO2

0–1 1–5 5–7 7 – 10 >10

± 0.1 ± 0.2 ± 0.3 ± 0.5 Not specified

N2O O2 Agent

0.1 0.1 0.3

N2O

0 – 20 20 – 100

±2 ±3

CO2 O2 Agent

0 0 0

HAL ENF ISO

0-1 1-5 >5

± 0.15 ± 0.2 Not specified

CO2 N2O O2 2. Agent

0 0.1 0.1 0.2 (typical)

SEV

0–1 1–5 5–8 >8

± 0.15 ± 0.2 ± 0.4 Not specified

CO2 N2O O2 2. Agent

0 0.1 0.1 0.2 (typical)

DES

0–1 1–5 5 – 10 10 – 15 15 – 18 >18

± 0.15 ± 0.2 ± 0.4 ± 0.6 ±1 Not specified

CO2 N2O O2 2. Agent

0 0.1 0.1 0.2 (typical)

O2 [OXIMA]

0 – 40 40 – 60 60 – 80 80 – 100 Offset

±1 ±2 ±3 ±4 ±1

-

O2 [SERVOMEX]

0 – 25 25 – 90 90 – 100

±1 ±2 ±3

CO2 N2O Agent

0.2 0.2 1.0

Table 12: Accuracy of sidestream gas measurement

For testing and calibration with mixed gas, the interferences have to be considered. In addition, the tolerances of the test gas must be considered.

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Chapter 8: Tests

Testing multi gas analyzer: Perform the following test items in the according order, if there is a problem regarding gas measurement. Test item Gas measurement leakage test Hardware calibration Servomex (if available) Flow sensitivity Servomex (if available) Span calibration (100% calibration O2 sensor) Gas measurement accuracy test Calibration gas span (only if accuray test fails)

Chapter Chapter 8.17.1 chapter 7.8.3.2 and 7.8.3.3 Chapter 7.8.3.1 Chapter 7.8.2.3 Chapter 8.17.2 Chapter 7.8.2.1

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Chapter 8: tests

8.17.1

Gas measurement leakage test

Preliminary steps/test setup: Disconnect of the internal sample gas return Danger of damage to the device ACHTUNG



Use the port on the docking station for the leakage test.

Figure 58 shows the gas measurement device with an OXIMA sensor (fuel cell). On SERVOMEX devices, the sensor is not located in the water trap receptacle but inside the device right next to the measuring bench. Make sure that the tube to the glass of water is at least 1.5m Remove the patient module and attach a test tube of at least 1.5 m at the connection mandrel for the pressure measurement or the measurement gas recirculation. Close the swivel arm again and lock it. Water trap

Measuring bench

Intake fitting

Sample gas return

Swivel arm

Test tube

Glass of water

Tube length: min. 1,5m

Figure 58: Test setup for gas measurement leakage test

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Chapter 8: Tests

Procedure:

Chose „Yearly Maintenance“ „Leaktest ► Test“

option

Figure 59: Service menu gas measurement leak test



Close off the line connected to the water trap with the aspiration port.



Wait 60 sec. until the system stabilizes.



After 60 seconds, make sure no air is coming out at the measurement gas return (max. 2 air bubbles every 15 seconds). Ending the leaktest Moisture inside the gas measurement bench

CAUTION





First take the tube of the water; then you can end the test by pressing the “OK” button.

Take the measurement gas return out of the water and open up the closed line. Press the "OK" button to end the test. Record the results in the test log!

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Chapter 8: tests

8.17.2

Gas measurement accuracy test

Preliminary steps/test setup: Excess pressure build up at the supply to the water trap Danger of damage to the device CAUTION

 

Never connect the calibration gas bottle directly to the water trap! Install a rotameter between calibration gas and water trap

Use the T connection to attach the calibration gas bottle to the rotameter or flow analyzer. Make sure that there is a positive gas flow against the ambient air at the rotameter/flow analyzer. This ensures that no ambient air enters the measurement setup and falsifies the measurement.

Rotameter (Flow-Analyzer)

>0 ml /min

T-Fitting

Water trap

Calibration gas

Figure 60: Test setup up gas measurement accuracy

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Chapter 8: Tests

Procedure AION 03 with automatic gas detection (red) and AION 01 with N2O and CO2 detection (green): Go to the menu item: "Service ►AION“: Choose „Yearly Maintenance“ option „Gas Measurement Test ►Test“

Figure 61: Service menu gas monitor test



Make sure that the gas monitor is in "Full Accuracy" mode. If needed, wait several minutes until "Full Accuracy" mode is reached.



Carefully open the valve to the test gas bottle.



Wait until the readings have stabilized on the display. Gas measuring bench AION 01 (green) does not display any agent gas, only CO2 and N2O. If the device is without integrated O2 measurement no O2 value is displayed.



Record the readings and ensure that the maximum tolerances have not been exceeded.



Press the "OK" button to end the test. Record the results in the test log! If the test yields a negative result, the sidestream measurement needs to be calibrated.

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Chapter 8: tests

Procedure AION 02 without automatic gas detection (orange): Before starting the test, the gas type has to be selected manually. 

Therefore, change to the ventilation screen and start any kind of ventilation



In the window of the gas measurement click on the unfilled place



In the opening window choose the gas type of your calibration gas

Figure 62: Selection of the calibration gas



Change back to service menu: “Service ►AION”



Chose „Yearly Maintenance“ option „Gas Measurement Test ► Test“

Figure 63: Service menu gas monitor test



Make sure that the gas monitor is in "Full Accuracy" mode. If needed, wait several minutes until "Full Accuracy" mode is reached.



Carefully open the valve to the test gas bottle.



Wait until the readings have stabilized on the display. If the device is without integrated O2 measurement no O2 value is displayed.



Record the readings and ensure that the maximum tolerances have not been exceeded.



Press the "OK" button to end the test. Record the results in the test log! If the test yields a negative result, the sidestream measurement needs to be calibrated.

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Chapter 8: Tests

8.17.3

Zero reference valve test

Preliminary steps/test setup: Use the test setup described in 8.17.2 (page 8-68); keep this same setup.

Procedure:

Chose „Yearly Maintenance“ option „Zero Ref. Ventil-Test ►Calibrate“ Figure 64: Service menu zero reference valve test



Make sure that the gas monitor is in "Full Accuracy" mode. If needed, wait several minutes until "Full Accuracy" mode is reached.



AION 02 without automatic gas detection (orange): follow the description under point 8.17.2



Carefully open the valve to the test gas bottle.



Wait until the readings have stabilized on the display.



Record the readings and ensure that the maximum tolerances have not been exceeded.



Press the "OK" button to end the test.

Record the results in the test log!

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Chapter 8: tests

8.18

O2 monitor test

8.18.1

O2 sidestream measurement

Test setup: Remove the patient module from the docking station. Use the shown test-setup. Be sure that the tube between the T-Fittings has a maximum length of 10 cm

Water trap

The length of all other tubes doesn’t matter. They should not be longer than 2 meters.

Internal sample gas feedback line

For this you could use the test tube for O2 sidestream measurement (item no 0209091).

T-Fitting

Gas-Monitor (Flow-Analyzer)

10 cm

Inlet: High-Flow Gas type: any T-Fitting

Swivel arm

A

Patient module control switch

Figure 65: O2 monitor test setup (sidestream)

Close the swivel arm, after you have set up the test setup. Lock the control switch (A) in the pressed position, in order to enable manual ventilation.

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Chapter 8: Tests

Procedure:   

Switch to the ventilation screen Start the manual ventilation leonplus: Set the listed test settings

Figure 66: O2 oxygen measurement test settings



leon: Dose the following fresh gas settings with the help of the AIR and O2-spindle

AIR (l/min) 9 2 0

O2 (l/min) 0.5 2 3

O2 % 25% 60% 100%

Table 13: settings O2-measurement

O2-Measurement value

For each setting in the following table, check if the deviation between the readings of the leonplus/leon and the Flow analyzer is in the permissible range. Record the results in the test log!

Figure 67: O2 oxygen measurement test

The displayed value of the gas monitor (flow analyzer), not the set O2 value, is the valid reference for the allowed deviation. Thus, the permissible deviation relates to the difference between the leonplus/leon display and the Flow Analyzer display. Fresh gas dosing settings 25 % 60 % 100 %

Permissible measurement deviation ±2% ±3% ±4%

Table 14: O2 monitor testing parameters

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Chapter 8: tests

8.18.2

O2 Mainstream monitor

Test setup: Remove the patient module from the docking station and use the shown test-setup.

IRMA-Sensor

Gas-Monitor (Flow-Analyzer) Inlet: High-Flow Gas type: any

A Swivel arm

Patient module control switch

Figure 68: O2 monitor test setup (mainstream)

Close the swivel arm, after you have set up the test setup. Lock the control switch (A) in the pressed position, in order to enable manual ventilation. The following test procedure is identical to the O2 sidestream measurement (see section 8.18.1, page 8-73).

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Chapter 8: Tests

8.18.3

O2 fuel cell

Test setup: Remove the patient module from the docking station and use the shown test-setup. fuel cell

Gas-Monitor (Flow-Analyzer)

Adapter AD 22m – 22m (Art. Nr. 0045004)

Inlet: High-Flow Outlet: High-Flow Gas type: any

A

Docking station Patient module control switch Figure 69: O2 monitor test setup (fuel cell)

Close the swivel arm after you have set up the test setup. Lock the control switch (A) in the pressed position, in order to enable manual ventilation. Navigate to the menu item “Service ► Device ► Flowboard” Note the actual oxygen concentration displayed under “Oxy %”

O2 measurement value

Figure 70: Test oxygen measurement FiO2

The following procedure is according to O2 sidestream measurement.

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Chapter 8: tests

8.19

Functional test of fresh gas blender (overall function) (only leonplus)

The fresh gas generator test ensures that the mix ratios generated are within allowable tolerances! Once successfully conducted, the test also guarantees that the gas lines are attached to the correct connections and have not been mistakenly interchanged. Incorrectly dosed fresh gas Life-threatening situation to a patient

DANGER



Exercise extreme care when conducting this test.



Always close the rear panel of the housing before starting this test



To test the fresh gas blender, either use internal multi gas analyzer that has already been tested or a comparable, calibrated monitoring device

Procedure: 

Set up the test setup of O2 sidestream measurement (see 8.18.1, page 8-72)



Connect the outlet flow analyzer to the AGS to be sure that no nitrous oxide reaches the ambient air if nitrous oxide is available.



Log out of the Service menu.



Switch to the ventilation mode screen.



Enable the "Manual/Spontan." Manual ventilation mode.



Set the fresh gas flow to 2 l/min!



Select "AIR" as the carrier gas.



One after the other, select the settings shown below with oxygen concentrations of 21, 40, 60, 80 and 100%. Wait for the gas monitor display to stabilize before entering the reading in the test log.

Figure 71: Test settings carrier gas "AIR"

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Chapter 8: Tests



The listed mixture concentration may deviate ± 5%ABS maximum. For each setting the oxygen content may not be lower than 21%.



Repeat the test for the mixture concentration using a flow of 7 l/min and 18 l/min. Record the results in the test log!



Select "N2O" as the carrier gas. (only for devices with nitrous oxide option)



One after the other, select the settings shown below with oxygen concentrations of 25, 40, 60, 80 and 100%. Wait for the gas monitor display to stabilize before entering the reading in the test log.

Figure 72: Test settings carrier gas "N2O"



The listed mixture concentration may deviate ± 5%ABS maximum. For each setting the oxygen content may not be lower than 21%.



Repeat the test for the mixture concentration using a flow of 7 l/min and 18 l/min. Record the results in the test log!

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Chapter 8: tests

8.20

Function test of nitrous oxide gas lock (only leonplus)

The nitrous oxide cutoff is electronically controlled, but does have a pneumatic/mechanical fallback solution that keeps the patient from being given 100% nitrous oxide in the event of a total system failure or if the electronics fail to properly controlling the valves.

Preliminary steps / test setup:

AION

leon(plus)

EXT FG / O2 INSP

BAG EXP

?

min. 80 cm

Flow Analyzer Inlet: High Flow Gas type: ATP AIR

Figure 73: Nitrous oxide cutoff test (test setup)

If the leonplus contains an internal gas measurement, it can be used for the test. For devices without multi gas analyzer the measurement has to be made with an independent O2 meter. (Flow Analyzer, PF-300) The pneumatic nitrous oxide cutoff has to be proved with a flow analyzer.

8-78

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Chapter 8: Tests

Procedure: Testing electronic cutoff of nitrous oxide (Only for devices with nitrous oxide option)

Blender settings: 

Select N2O as carrier gas.



Set 80% O2 at 2 l/min.



Pull the O2 connection hose out of the wall supply.

The leonplus must respond as follows: 

The fresh gas blender window is disabled.



The message “S: O2 supply failed. Dosing fresh gas with air (=21% O2)” appears.



The O2 content of the fresh gas drops from 80% to 21%. (The value must stabilize at 21%).

Record the results in the test log! The oxygen content must never drop below 21% after the O2 supply is interrupted. If the value does fall below 21%, check the tubing and the electrical connections of the switch block and repeat the test. If necessary, replace the switch block!

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Chapter 8: tests

Testing the pneumatic cutoff for laughing gas (fallback solution) (Only for devices without nitrous oxide option) Go to the menu item: "Service ►Device ►Valves“:

Direct control of fresh gas valves Carrier gas switchover. (Solenoid valve E) Active: N2O Inactive: AIR

Figure 74: Testing the pneumatic cutoff of nitrous oxide

Valve settings: 

Switch to N2O carrier gas (“Fresh gas Air/N2O” active).



Set the O2 to approx. 80% (valves 0 and 20 = on).



Pull the O2 connection hose out of the wall supply.

The leon(plus) must respond as follows: 

The O2 content of the fresh gas drops from approx. 80% to 21%. (The value must stabilize at 21%).

Record the results in the test log!

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Chapter 8: Tests

8.21 N o. 1

Docking check To ensure that the patient module is properly connected to the leonplus, the docking function must be tested.

Function Plateau valve

2

OS switchover

3

Auto/Man. switch

4

Fresh gas (FG)

5

Airway pressure (Paw)

6

Excess diaphragm (HM) Patient module locking mechanism

7

Make sure that all the transition adapters (2-6) move easily and return to their initial positions. Check if all O-rings are located in the corresponding seating of the swivel arm and the plateau valve (1), and if they are not damaged!

1

Plateau valve

LP- port

7

HP port

4

6 2 5

3 Figure 75 : Docking check

Be sure to check the following: 

Plateau valve port (1) ► Springiness? Easy to move? O rings present?



Transition adapters (2-6) ► Springiness? Easy to move?



Swivel arm connection surfaces ► Clean? O rings present?

Record the results in the test log!

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Chapter 8: tests

8.22

Testing the patient module/circle system

The patient module test is divided into individual steps. They test each of the internal components.

Patient module top 3

Intermediate plate 1

Patient module bottom 5

2

10

9

6 4

7 11

12

8

Figure 76: Patient module overview

No. 1 2 3 4 5 6 7 8 9 10 11 12

Abbreviation OS AM1 AM2 HM VC1 VC2 IN- Mem EX-Mem EK-Mem OS-Mem EA valve APL

Description "Open System" slide valve "Autom./Manual" slide valve (1) "Autom./Manual" slide valve (2) Excess diaphragm Voice Coil 1 (plateau valve) (outside the patient module) Voice Coil 2 (Peep valve) “Inspiration” diaphragm “Expiration” diaphragm “Decoupling” diaphragm "Open System" diaphragm Emergency air valve APL valve

Table 15: Patient module components (overview)

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Chapter 8: Tests

6 7 8 1

11

2

9

12

10

3 4 5

Figure 77: Patient module overview (diagram)

No. 1 2 3 4 5 6 7 8 9 10 11 12

Abbreviation OS AM1 AM2 HM VC1 VC2 IN- Mem EX-Mem EK-Mem OS-Mem EA valve APL

Description "Open System" slide valve "Autom./Manual" slide valve (1) "Autom./Manual" slide valve (2) Excess diaphragm Voice Coil 1 (plateau valve) (outside the patient module) Voice Coil 2 (Peep valve) “Inspiration” diaphragm “Expiration” diaphragm “Decoupling” diaphragm "Open System" diaphragm Emergency air valve APL valve

Table 16: Patient module components (schematics)

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Chapter 8: tests

E

A

B

C D

G F

Figure 78: Overview of tube connections

A B C D E F G

Fresh gas outlet (FG) optional: O2 outlet Expiration connection (Exp.) Inspiration connection (Insp.) Manual ventilation bag connection (BAG) Switchover to fresh gas outlet optional: O2 flow meter Bellows (in the dome) Test adapter patient module Table 17: Overview of tube connections

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Chapter 8: Tests

8.22.1

Testing the APL valve

Preliminary steps: Make sure that the leonplus/leon is connected to the gas supply (central gas supply or gas cylinder)

2

Connect the breathing bag (1) and fresh gas outlet (2) connectors with each other. Connect the inspiration (3) and expiration (4) connectors with each other.

4 1

3

Figure 79: Testing the APL valve (connections)

Test setup:

leonplus / leon Ext. FG/O2 INSP

BAG EXP

22mm breathing tube

Pressure measurement tube

Manometer (Flow Analyzer)

Inlet: Low Pressure

Figure 80: Testing the APL valve (test arrangement)

If the device does not offer an external fresh gas resp. O2 outlet the BAG connection has to be short circuited by the test adapter of the patient module. Therefore the tube including connection adapter of the breathing bag has to be plugged on the test adapter. See test setup in Figure 3: Alternative test setup pressure monitor

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Chapter 8: tests

Procedure: 

Write down the APL valve serial number in the test log (if available)



Start the manual ventilation mode



Set fresh gas control to 6 l/min at 21% O2

Fresh gas control: 6 l/min at 21% (mit AIR)

Figure 81: APL test fresh gas settings leonplus



Adjust all values at the APL according to the table below and check that the measured pressure lies within the permissible range.

Tightness test APL valve: 

Turn APL to “SP” → The system is decompressed



Turn the APL to 90 cmH2O → At 200 ml/min fresh gas flow the pressure must rise to at least 30 cmH2O.

APL setting 10 cmH2O 20 cmH2O 30 cmH2O 50 cmH2O 70 cmH2O SP (0 cmH2O) 90 cmH2O (at 200 ml/min)

Min. value 7 cmH2O 16 cmH2O 25 cmH2O 43 cmH2O 60 cmH2O 0 cmH2O 30 cmH2O

Max. value 24 cmH2O 35 cmH2O 57 cmH2O 80 cmH2O 5 cmH2O

Table 18: APL test parameters

Record the results of the tests in the test log! 8-86

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Chapter 8: Tests

8.22.2

Manual patient module leak test

Test setup:

leonplus / leon EXT FG / O2

BAG

INSP

EXP

Inlet: Low Pressure

Flow Analyzer

Pressure measurment Figure 82: Manual patient module leak test (test setup)

If the device does not offer an external fresh gas resp. O2 outlet the BAG connection has to be short circuited by the test adapter of the patient module. Therefore the tube including connection adapter of the breathing bag has to be plugged on the test adapter. See test setup in Figure 3: Alternative test setup pressure monitor Procedure:       

Prepare test setup according to Figure 82. Make sure that an absorber is attached to the patient module. Set the APL valve to “SP” Switch to Service mode Go to the menu item: "Service ►Device ►Valves“: Close the excess diaphragm. Using the fresh gas valves (16+17) set a fresh gas flow of appr. 105 ml/min

Expected reaction: 

The pressure in the patient module stabilizes at ≥30 cmH2O. If the pressure of 30 cmH2O is not reached, check first the tightness of the absorber and the inspection glass (insp./exp)

Record the results in the test log!

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Chapter 8: tests

8.22.3

Step 1

Test setup:

leonplus / leon Ext.FG/O2 INSP

BAG EXP

Pressure Meter (Flow Analyzer) Inlet: Low Pressure Test lung

Figure 83: Patient module test – step 1

Procedure:     

Make sure that all valves are in passive state (start position) Open the "ExpValve" (plateau valve) -> [Value: 0] Open the "PeepValve" (plateau valve) -> [Value: 0] Close the "ExpValve" (plateau valve) -> [Value: 511] Open the drive gas valve 11 (for 10 l/min) until the bellows (in the dome) is at the top

Expected reaction:  

Bellows (in the dome) rises Test lung remains empty

Functions/components/modules tested:  

AM1 in quiescent state [0] VC1: (plateau or exp. ExpValve) is controlled and closes [1]

Record the results in the test log! If the device does not respond as expected, check the following parts:   

8-88

AM1: O rings, moveability VC1: Control, tightness Seals on the dome/bellows holder/bellows

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Chapter 8: Tests

8.22.4

Step 2

Test setup:

leonplus / leon Ext.FG/O2

BAG

INSP

EXP

Pressure Meter (Flow Analyzer) Inlet: Low Pressure Test lung

Figure 84 : Patient module test – step 2

Procedure:  

Close all drive gas valves Open the "ExpValve" (plateau valve) -> [Value: 0] (all valves have returned to passive state)

Expected reaction:  

Bellows (in the dome) drops Test lung remains empty

Functions/components/modules tested: 

VC1: (plateau or ExpValve) is not controlled and is open [0]

Record the results in the test log! If the device does not respond as expected, check the following parts:  

VC1: O rings, moveability AM1: O rings, moveability

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Chapter 8: tests

8.22.5

Step 3

Test setup:

leonplus / leon Ext.FG/O2 INSP

BAG EXP

Pressure Meter (Flow Analyzer) Inlet: Low Pressure Test lung

Figure 85 : Patient module test – step 3

Procedure:     

Starting position: All valves in passive state Turn on "AutoManual" Close the "ExpValve" (plateau valve) -> [Value: 511] Open the drive gas valve until the airway pressure (Paw) reaches > 60 cmH2O Close all the drive gas valves when the pressure is attained

Expected reaction:    

Bellows (in the dome) rises, test lung fills up Test lung stays fill after the drive gas is turned off (at least 10 sec.) Paw remains higher than 40 cmH2O for at least 10 sec. The bellows stays up at the same time

Functions/components/modules tested:     

AM1: is controlled and activated [1] EK-Mem: "Decoupling" flap valve closes [0] VC1: (plateau or exp. ExpValve) is controlled and closes [1] IN- Mem: "Inspiration" flap valve opens [1] NL valve: Emergency air valve closes [0]

Record the results in the test log! If the device does not respond as expected, check the following parts:      8-90

AM1: Control, O rings, moveability EK-Mem: Seated correctly, check for holes and tears VC1: Control, tightness IN- Mem: Seated correctly, clean NL valve: Proper seat, check for tightness Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

Chapter 8: Tests

8.22.6

Step 4

Test setup:

leonplus / leon Ext.FG/O2 INSP

BAG EXP

Pressure Meter (Flow Analyzer) Inlet: Low Pressure Test lung

Figure 86 : Patient module test – step 4

Procedure:  

Leave "AutoManual" turned on Open the "ExpValve" (plateau valve) -> [Value: 0]

Expected reaction:  

Bellows (in the dome) drops Test lung remains filled (Paw > 40 cmH2O at least 10 sec.)

Functions/components/modules tested:   

VC1: (plateau or ExpValve) is not controlled and is open [0] EK-Mem: "Decoupling" diaphragm opens [1] IN Mem: "Inspiration" diaphragm closes [0]

Record the results in the test log! If the device does not respond as expected, check the following parts:   

VC1: Tightness, flexibility EK-Mem: Seated correctly, clean IN Mem: Seated correctly, check for holes and tears

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Chapter 8: tests

8.22.7

Step 5

Test setup:

leonplus / leon Ext.FG/O2

BAG

INSP

EXP

Pressure Meter (Flow Analyzer) Inlet: Low Pressure Test lung

Figure 87 : Patient module test – step 5

If the device does not offer an external fresh gas resp. O2 outlet the BAG connection has to be short circuited by the test adapter of the patient module. Therefore the tube including connection adapter of the breathing bag has to be plugged on the test adapter. See test setup in Figure 3: Alternative test setup pressure monitor Procedure:        

Connect bag connector with Ext. FG/O2 Remove the test lung from the INSP connection to vent the system Reconnect the test lung Open the "ExpValve" (plateau valve) -> [Value: 0] Turn off "AutoManual" Set a pressure of 30 cmH2O at the APL valve Open the fresh gas valve 8 ( for 9 l/min AIR) Close fresh gas valve 8 again, after the lung is filled.

Expected reaction:  

Bellows (in the dome) stays down Test lung fills to Paw = APL pressure (approx.)

Functions/components/modules tested:     

EK-Mem: "Decoupling" diaphragm opens [1] IN Mem: "Inspiration" diaphragm opens [1] NL valve: Emergency air valve closes [0] EX-Mem: "Inspiration" diaphragm closes [0] APL

Record the results in the test log! If the device does not respond as expected, check the following parts:  EK-Mem: Seated correctly, clean  NL valve: Seated correctly, clean  IN Mem: Seated correctly, clean  EX-Mem: Seated correctly, cleanliness, check for holes and tears 8-92

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Chapter 8: Tests

8.22.8

Step 6

Test setup:

leonplus / leon Ext.FG/O2 INSP

BAG EXP

Pressure Meter (Flow Analyzer) Inlet: Low Pressure

Test lung

Figure 88 : Patient module test – step 6

If the device does not offer an external fresh gas resp. O2 outlet the BAG connection has to be short circuited by the test adapter of the patient module. Therefore the tube including connection adapter of the breathing bag has to be plugged on the test adapter. See test setup in Figure 3: Alternative test setup pressure monitor Procedure:     

Set up test setup according to Figure 88 Starting position: All valves in passive state Set a pressure of 70 cmH2O at the APL valve Close the "PeepValve" -> [Value: 511] Open the fresh gas valve 8 ( for 9 l/min AIR)

Expected reaction:  

Paw rises to APL pressure Test lungs is filled (appr. 70 cmH2O)

Functions/components/modules tested:     

IN Mem: "Inspiration" diaphragm opens [1] EK-Mem: "Decoupling" diaphragm opens [1] NL valve: Emergency air valve closes [0] AM2: in quiescent state [0] APL

Record the results in the test log! If the device does not respond as expected, check the following parts:  IN Mem: Seated correctly, clean  EK-Mem: Seated correctly, clean  NL valve: Proper seat, check for tightness  AM2: O rings, movability

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Chapter 8: tests

8.22.9

Step 7

Test setup:

leonplus / leon Ext.FG/O2 INSP

BAG EXP

Pressure Meter (Flow Analyzer) Inlet: Low Pressure

Test lung

Figure 89 : Patient module test – step 7

If the device does not offer an external fresh gas resp. O2 outlet the BAG connection has to be short circuited by the test adapter of the patient module. Therefore the tube including connection adapter of the breathing bag has to be plugged on the test adapter. See test setup in Figure 3: Alternative test setup pressure monitor Procedure: 

Turn on "AutoManual"

Expected reaction:  

Test lung remains filled (at least 10 sec.) Paw remains > 50 cmH2O (at least 10 sec.)

Functions/components/modules tested: 1. VC2: (Peep valve) is controlled and closed [1] 2. IN Mem: "Inspiration" flap valve closes [0]

Record the results in the test log! If the device does not respond as expected, check the following parts:  

8-94

VC2: Cleanliness and installation direction of the diaphragm, drive flexibility IN Mem: Seated correctly, check for holes and tears

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

Chapter 8: Tests

8.22.10

Step 8

Test setup:

leonplus / leon Ext.FG/O2

BAG

INSP

EXP

Pressure meter (Flow Analyzer) Eingang: Low-Pressure

Test lung

Figure 90 : Patient module test – step 8

If the device does not offer an external fresh gas resp. O2 outlet the BAG connection has to be short circuited by the test adapter of the patient module. Therefore the tube including connection adapter of the breathing bag has to be plugged on the test adapter. See test setup in Figure 3: Alternative test setup pressure monitor Procedure: 

Open the "PeepValve" -> [Value: 0]

Expected reaction:  

Test lung is vented Paw drops (< 3 cmH2O)

Functions/components/modules tested:   

EX-Mem: "Expiration" flap valve opens [1] VC2: (Peep valve) without control and is open [0] AM2: is controlled and activated [1]

Record the results in the test log! If the device does not respond as expected, check the following parts:   

EX-Mem: Seated correctly, clean VC2: Moveability, cleanliness of the Peep diaphragm AM2: O rings, movability

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

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Chapter 8: tests

8.22.11

Step 9

Test setup:

leonplus / leon Ext.FG/O2 INSP

BAG EXP

Pressure meter (Flow Analyzer) Inlet: Low-Pressure

Figure 91 : Patient module test – step 9

If the device does not offer an external fresh gas resp. O2 outlet the BAG connection has to be short circuited by the test adapter of the patient module. Therefore the tube including connection adapter of the breathing bag has to be plugged on the test adapter. See test setup in Figure 3: Alternative test setup pressure monitor Procedure:  

Remove test lung from the tube system and close tube Close excess diaphragm

Expected reaction: 

Pressure rises at least 80 cmH2O

Functions/components/modules tested: 

HM: Excess diaphragm closes [1]

Record the results in the test log! If the device does not respond as expected, check the following parts: 

8-96

HM: Seated correctly, check for holes and tears, check valve seat

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

Chapter 8: Tests

8.22.12

Patient module test procedures (overview)

Table 19: Patient module test table

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

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Chapter 8: tests

8.22.13

Minimal-Flow test

Test setup:

leon/leonplus Ext.FG/O2 INSP

BAG EXP

Breathing bag

Test lung

Procedure: 

Log out of Service menu!



Change to Standy mode.



Set up leon/leonplus according to the following table.

Mode IMV: Operating mode leon/leonplus Category Kind Mode IMV Fresh gas dosing leon/leonplus O2 fresh gas flow 21% 0.2 l/min 

Start ventilation.



Press Flush-Button to fill breathing bag.

Ventilation parameter leon/leonplus Freq. (1/min) 20 I:E 1:2 Plateau AUS VTI (ml) 200 PMax (cmH2O) 20 Peep (cmH2O) OFF

Wait at least 60 seconds before recording the test results to the test log. 

Make sure that the breathing bag stays filled.



Record the result in the test log.

test item Bag stays filledt

8-98

ERROR

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

OK

Chapter 8: Tests

8.22.14

Heater function test

Make sure that the patient module’s heater is functioning. After one hour of operation the leonplus/leon patient module has to be heated noticeable. Record the results in the test log.

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8-99

Chapter 8: tests

8.23

Testing the ventilation function

8.23.1

Testing IMV mode (volume measurement)

Test setup:

leonplus / leon EXT FG / O2 INSP

Pressure sample line

22mm tube

BAG EXP

Breathing bag for manual ventilation

FlowAnalyzer

Inlet: High Flow + Low Pressure Gas type: AIR ATP

Settings: Test lung

C = Compliance: 10, 20 RP = Resistance: 20, 50

Figure 92 : Testing IMV mode (test setup for volume measurement)

Procedure: 

Log out of the Service menu!



Switch into standby mode.



Use the settings in the following table for the leonplus / leon and the test lung.



Start the ventilation. Between the individual test steps, only values in fields with white background must be changed.

8-100

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Chapter 8: Tests

Device settings: leonplus/leon fresh gas dosing Air/O2 21% Flow amount 2 l/min

Carry out the IMV mode with these settings for fresh gas dosing.

IMV 40 ml mode leonplus / leon operating modes Category Child Mode IMV Test lung settings Compliance 10 Resistance 50

leonplus / leon ventilation parameter Freq.(1/min) 60 I:E 1:2 Plateau OFF VTi (ml) 40 PMax (cmH2O) 80 Peep (cmH2O) 5

IMV 200 ml mode leonplus / leon operating modes Category Child Mode IMV Test lung settings Compliance 10 Resistance 50

leonplus / leon ventilation parameter Freq.(1/min) 40 I:E 1:2 Plateau OFF VTi (ml) 200 PMax (cmH2O) 80 Peep (cmH2O) 5

IMV 400 ml mode leonplus / leon operating modes Category Adult Mode IMV Test lung settings Compliance 20 Resistance 20

leonplus / leon ventilation parameter Freq.(1/min) 20 I:E 1:2 Plateau OFF VTi (ml) 400 PMax (cmH2O) 80 Peep (cmH2O) 0

IMV 800 ml mode leonplus / leon operating modes Category Adult Mode IMV Test lung settings Compliance 20 Resistance 20

leonplus / leon ventilation parameter Freq.(1/min) 10 I:E 1:2 Plateau OFF VTi (ml) 800 PMax (cmH2O) 80 Peep (cmH2O) 0

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Chapter 8: tests

IMV 1200 ml mode leonplus / leon operating modes Kategorie Adult Modus IMV Test lung settings Compliance 20 Resistance 20

leonplus / leon ventilation parameter Freq.(1/min) 6 I:E 1:2 Plateau OFF VTi (ml) 1200 PMax (cmH2O) 80 Peep (cmH2O) 0

Measurement: Flow analyzer inlet High-Flow + Low pressure Gas type: Air, ATP Specifications: VTi setting 40 ml 200 ml 400 ml 800 ml 1200 ml

Permissible min. 30 ml 170 ml 340 ml 680 ml 1020 ml

Permissible max. 50 ml 230 ml 460 ml 920 ml 1380 ml

Table 20: IMV mode testing parameters

After you change each of the settings, allow the device at least 60 seconds before you enter the values displayed into the test log.

Record the test results in the test log.

8-102

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Chapter 8: Tests

8.23.2

Testing the PSV trigger

Test setup:

22mm tube

leonplus / leon EXT FG / O2 Pressure sample line

INSP

BAG EXP

Breathing bag for manual ventilation

Flow Analyzer

Inlet: High Flow + Low Pressure Gas type: Air ATP

Settings: Test lung

C = Compliance: 10, 20 RP = Resistance: 20, 50 Figure 93 : Testing the PSV trigger (test setup)

Procedure: 

Use the settings in the following table for the leonplus / leon and the test lung and then start ventilation. Between the individual test steps, only values in fields with white background must be changed.

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Chapter 8: tests

Device settings leonplus / leon fresh gas dosing Air / O2 21% Flussmenge 2 l/min

Carry out the PSV trigger check with these setting for the fresh gas dosing.

PSV trigger mode Betriebsart leonplus / leon Category Adult Mode PSV

leonplus / leon ventilation parameter PInsp (cmH2O) 40 Peep (cmH2O) OFF Trigger (l/min) 0.1 Backup (s) 15s

Test lung settings Compliance 20 Resistance 20 Try to trigger a trigger by manual stretching the test lung. Make sure that the device supports the “requested” breath. Enter the result into the test log!

PSV trigger test results Test step Trigger can be released Without trigger a backup breath is administered every 15s

ERROR

Table 21: Testing parameters PSV Trigger

After you change each of the settings, allow the device at least 60 seconds before you enter the values displayed into the test log.

8-104

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

OK

Chapter 8: Tests

8.23.3

Testing PCV mode (pressure control)

Test setup:

leonplus / leon EXT FG / O2 INSP

Pressure sample line

22mm tube

BAG EXP

Breathing bag for manual ventilation

Flow Analyzer

Inlet: High Flow + Low Pressure Gas type: ATP AIR

Settings: Test lung

C = Compliance: 10, 20 RP = Resistance: 20, 50

Figure 94 : Testing PCV mode pressure control (test setup)

Procedure: 

Log out of the Service menu!



Switch into standby mode.



Use the settings in the following table for the leonplus / leon and the test lung.



Start the ventilation. Between the individual test steps, only values in fields with white background must be changed.

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

8-105

Chapter 8: tests

Device settings: Measurement: Flow analyzer inlet High-Flow + Low pressure Gas type: Air ATP PCV mode: PInsp leonplus / leon operating modes Category Child Mode PCV Test lung settings Compliance 10 Resistance 50

PInsp + fresh gas dosing leonplus / leon

Set the values shown on the right for PInsp and fresh gas dosing. Check the measurement and enter he result into the test log!

PCV test results: PInsp Leonplus / leon PInsp Ppeak Peep 10 cmH2O 20 cmH2O 30 cmH2O 60 cmH2O

leonplus / leon ventilation parameter Freq.(1/min) 15 I:E 1:1 Plateau 10% PInsp (cmH2O) 10 Peep (cmH2O) OFF

Meter: Pmax Peep

PInsp (cmH2O) 10 20 30 60

Fresh gas (21% O2) 0.5 l/min 0.5 l/min 2 l/min 4 l/min

Specification Ppeak/max Peep 9-11 0-2 18-22 0-2 28-32 0-2 57-63 0-2

ERROR

OK

Table 22: Testing parameters PCV-Mode: Pinsp

PCV mode: Peep leonplus / leon Operating modes Category Adult Mode PCV Test lung settings Compliance 20 Resistance 20

leonplus / leon ventilation parameter Freq.(1/min) 15 I:E 1:1 Plateau 10% PInsp (cmH2O) 30 Peep (cmH2O) AUS Peep + fresh gas dosing leonplus / leon

Set the values shown on the right for Peep. Check the measurement and enter into the test log!

8-106

Peep (cmH2O) 5 10 15 20

Frischgas (21% O2) 2 l/min 2 l/min 0.5 l/min 0.5 l/min

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

Chapter 8: Tests

PCV test results: Peep leonplus / leon Peep Ppeak Peep OFF 5 cmH2O 10 cmH2O 15 cmH2O 20 cmH2O

Meter: Pmax Peep

Specification Ppeak/max Peep 28-32 0-2 28-32 4-6 28-32 9-11 28-32 14-16 28-32 19-21

ERROR

OK

Table 23: Testing parameters PCV mode: PEEP

After you change each of the settings, allow the device at least 60 seconds before you enter the values displayed into the test log.

8.24

Electrical safety test



Test according to DIN EN 60601-1 during manufacturing test/initial start-up of device (Printout GM test software)



Test according to DIN VDE 0751 during maintenance and service (According to PA-10-17)

Settings Secutest: safety class: 1B, leakage current: ΔI Record the test results in the test log.

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.4

8-107

chapter 9: Repairs

9.

Repairs

Contents 9. Repairs ..................................................................................................................... 9-1 9.1 Opening rear panel .............................................................................................. 9-7 9.2 Replacement connector block/switch block ......................................................... 9-8 9.2.1 required materials ............................................................................................. 9-8 9.2.2 Removing the gas box ...................................................................................... 9-9 9.2.3 Disconnecting tube and cable connections..................................................... 9-10 9.2.4 Calibration procedures after replacement connector/switch block.................. 9-12 9.2.5 Testing the gas box......................................................................................... 9-12 9.3 Replacement generator module ........................................................................ 9-13 9.3.1 Required materials.......................................................................................... 9-13 9.3.2 Components leonplus ..................................................................................... 9-13 9.3.3 Procedure leonplus ......................................................................................... 9-14 9.3.4 Components leon............................................................................................ 9-16 9.3.5 Procedure leon ............................................................................................... 9-16 9.3.6 Calibration after replacement generator module............................................. 9-18 9.3.7 Testing generator module ............................................................................... 9-18 9.4 Replacement gas measurement........................................................................ 9-19 9.4.1 Replacement gas measurement AION 01/AION 02/AION 03......................... 9-20 9.4.1.1 Required material ........................................................................................ 9-20 9.4.1.2 Version 1: AION 01/02/03 with Servomex oxygen measurement ............... 9-21 9.4.1.3 Version 2: AION 01/02/03 with Oxima oxygen measurement ..................... 9-22 9.4.1.4 Version 3: AION 01/02/03 without integrated oxygen measurement .......... 9-23 9.4.2 Replacement Servomex oxygen measurement .............................................. 9-24 9.4.2.1 Required materials ...................................................................................... 9-24 9.4.2.2 Servomex oxygen measurement................................................................. 9-25 9.4.3 Replacement Oxima oxygen measurement cell ............................................. 9-26 9.4.3.1 Required material ........................................................................................ 9-26 9.4.3.2 Oxima oxygen sensor.................................................................................. 9-26 9.4.3.3 Calibration Oxima oxygen sensor ............................................................... 9-27 9.4.4 Replacement water trap receptacle ................................................................ 9-28 9.4.4.1 Required materials ...................................................................................... 9-28 9.4.4.2 Version 1: water trap receptacle.................................................................. 9-29 9.4.4.3 Version 2: water trap receptacle with Oxima fuel cell.................................. 9-30 9.4.5 Calibration gas measurement ......................................................................... 9-31 9.4.6 Testing the gas measurement ........................................................................ 9-31 9.5 Replacement Front module ............................................................................... 9-32 9.5.1 Replacement Display leonplus........................................................................ 9-32 9.5.1.1 Required materials ...................................................................................... 9-32 9.5.1.2 Disassembling display leonplus .................................................................. 9-32 9.5.1.3 Test after replacement display leonplus...................................................... 9-36 9.5.2 Replacement Display leon .............................................................................. 9-37 9.5.2.1 Required materials ...................................................................................... 9-37 9.5.2.2 Disassembling display leon......................................................................... 9-37 9.5.2.3 Testing after replacement display leon ....................................................... 9-42 9.5.3 Replacement controllerboard leon/leonplus................................................... 9-43 9.5.3.1 Required materials ...................................................................................... 9-43 9.5.3.2 Replacement controllerboard ...................................................................... 9-43 9.5.3.3 Test after replacement controllerboard ....................................................... 9-45 9.5.4 Replacement NetDCU leon/leonplus .............................................................. 9-46 9.5.4.1 Required materials ...................................................................................... 9-46 9.5.4.2 Replacement NetDCU................................................................................. 9-46 Heinen + Löwenstein, leonplus / leon Rev. 2.3.3

9-1

chapter 9: Repairs

9.5.4.3 9.5.4.4 9.5.5 9.5.5.1 9.5.5.2 9.5.6 9.5.6.1 9.5.6.2 9.5.6.3 9.5.7 9.5.7.1 9.5.7.2 9.5.7.3 9.5.8 9.5.8.1 9.5.8.2 9.5.8.3 9.6 9.6.1 9.6.2 9.6.3 9.7 9.7.1 9.7.2 9.7.3 9.8 9.8.1 9.8.2 9.8.3 9.8.4 9.8.5 9.8.6 9.9 9.9.1 9.9.2 9.9.3 9.10 9.10.1 9.10.2 9.10.3 9.10.4 9.10.5 9.10.6 9.10.7 9.11 9.11.1 9.11.2 9.12 9.12.1 9.12.2 9.12.3 9.13 9.14 9.14.1 9.14.2 9.14.3 9-2

Calibration after replacement NetDCU........................................................ 9-47 Test after replacement NetDCU .................................................................. 9-47 Replacement backlight inverter leon/leonplus ................................................ 9-48 Required material ........................................................................................ 9-48 Replacement backlight inverter ................................................................... 9-48 Replacement loudspeaker leon/leonplus....................................................... 9-49 Required materials ...................................................................................... 9-49 Replacement loud speaker.......................................................................... 9-49 Test after replacement loudspeaker............................................................ 9-49 Replacement rotary pulse encoder ................................................................. 9-50 Required materials ...................................................................................... 9-50 Replacement encoder ................................................................................. 9-50 Test after replacement encoder .................................................................. 9-50 Replacement keypad leon/leonplus ............................................................... 9-51 Required materials ...................................................................................... 9-51 Replacement keypad................................................................................... 9-51 Test after replacement keypad.................................................................... 9-52 Replacement rotameter block............................................................................ 9-53 Required materials.......................................................................................... 9-53 Disassembling rotameter block....................................................................... 9-53 Testing the rotameter block ............................................................................ 9-56 Replacement AC/DC converter ......................................................................... 9-57 Required materials.......................................................................................... 9-57 Disassembling AC/DC converter .................................................................... 9-57 Testing the AC/DC converter .......................................................................... 9-58 Rebuilding of the vaporizer holder ..................................................................... 9-59 Required material............................................................................................ 9-59 Differences vaporizer holder Dräger and Selectatec ...................................... 9-59 Replacement vaporizer holder ........................................................................ 9-60 Additional work steps change from Selectatec to Dräger vaporizer ............... 9-61 Calibration after the replacement of the vaporizer holder ............................... 9-62 Testing the vaporizer holder ........................................................................... 9-62 Replacement O-rings of vaporizer holder .......................................................... 9-63 Required materials.......................................................................................... 9-63 Replacement non-return valves ...................................................................... 9-63 Testing of non-return valves ........................................................................... 9-64 Replacement Mainboard/Adapterboard............................................................. 9-65 Required materials.......................................................................................... 9-65 Replacement Adapterboard ............................................................................ 9-66 Replacement Mainboard................................................................................. 9-67 Replacement CFB........................................................................................... 9-67 Software Update after replacement Adapterboard/CFB ................................. 9-68 Calibration after replacement Mainboard........................................................ 9-68 Testing the Mainboard/Adapterboard ............................................................. 9-68 Replacement Protocol interface......................................................................... 9-69 Required materials.......................................................................................... 9-69 Replacement Protocol Interface...................................................................... 9-69 Replacement mains connection board .............................................................. 9-70 Required materials.......................................................................................... 9-70 Replacement mains connection board............................................................ 9-70 Testing after replacement mains connection board ........................................ 9-71 Leakage patient module .................................................................................... 9-72 Replacement/Rebuilding bronchial aspiration ................................................... 9-73 Required materials.......................................................................................... 9-73 Aspiration AIR with injector ............................................................................. 9-74 Aspiration VAC with vacuum regulating valve ................................................ 9-74 Heinen + Löwenstein, leonplus / leon Rev. 2.3.3

chapter 9: Repairs

9.14.4 9.14.5 9.14.6 9.14.7 9.15 9.15.1 9.15.2 9.15.3 9.15.4 9.16 9.16.1 9.16.2 9.16.3 9.17 9.17.1 9.17.2

Replacement injector/vacuum regulating valve .............................................. 9-75 Rebuilding aspiration VAC to AIR ................................................................... 9-76 Rebuilding aspiration AIR to VAC ................................................................... 9-78 Testing the gas box......................................................................................... 9-79 Rebuilding option panel ..................................................................................... 9-80 Required material............................................................................................ 9-80 Rebuilding option panel to O2 outlet................................................................ 9-82 Rebuilding option panel to fresh gas outlet..................................................... 9-85 Testing the option panel.................................................................................. 9-88 Internal connection workstation illumination ...................................................... 9-89 Required material............................................................................................ 9-89 Installation of the internal connection workstation illumination ....................... 9-89 Testing the connection of the workstation illumination.................................... 9-90 Assembling workstation illumination .................................................................. 9-91 Required material............................................................................................ 9-91 Assembling the workstation illumination ......................................................... 9-91

Heinen + Löwenstein, leonplus / leon Rev. 2.3.3

9-3

chapter 9: Repairs

Figures Figure 1: opening rear panel .............................................................................................. 9-7 Figure 2: Removing gas box .............................................................................................. 9-9 Figure 3: components gas box......................................................................................... 9-10 Figure 4: Actors Connector Board.................................................................................... 9-12 Figure 5: generator module leonplus (left) / leon (right) ................................................... 9-13 Figure 6: ribbon cable to fresh gas blender and drive gas generator board .................... 9-14 Figure 7: Pressure sensors on drive gas generator board............................................... 9-15 Figure 8: generator module leon ...................................................................................... 9-16 Figure 9: Pressure sensors on drive gas generator board............................................... 9-17 Figure 10: gas measurement AION 03 with Servomex (leonplus) ................................... 9-19 Figure 11: AION with Servomex oxygen measurement and water trap ........................... 9-21 Figure 12: AION and water trap with Oxima oxygen measurement................................. 9-22 Figure 13: AION with water trap....................................................................................... 9-23 Figure 14: AION with Servomex oxygen measurement and water trap ........................... 9-25 Figure 15: Remove Oxima oxygen measurement cell ..................................................... 9-26 Figure 16: Position water trap receptacle......................................................................... 9-28 Figure 17: water trap receptacle and water trap receptacle with Oxima .......................... 9-28 Figure 18:AION with water trap receptacle ...................................................................... 9-29 Figure 19: AION with water trap receptacle Oxima fuel cell............................................. 9-30 Figure 20: rear view leonplus ........................................................................................... 9-32 Figure 21: Open panel rear side leonplus........................................................................ 9-33 Figure 22: Removing the holding plate AION (picture leon) ............................................ 9-33 Figure 23: Front module leonplus .................................................................................... 9-34 Figure 24: Differences display revision 3 to display revision 4......................................... 9-35 Figure 25: remove rotary pulse encoder .......................................................................... 9-35 Figure 26: switch leon / leoni............................................................................................ 9-36 Figure 27: rear view leon ................................................................................................. 9-37 Figure 28: Removing cover rear view leon ...................................................................... 9-38 Figure 29: Removing holding plates AION (picture leon)................................................. 9-38 Figure 30: Front module leon with rotameter block.......................................................... 9-39 Figure 31: Front view front module leon Version old, Version new.................................. 9-40 Figure 32: Rear view front module leon Version old, Version new .................................. 9-40 Figure 33: Replacement rotary pulse encoder ................................................................. 9-41 Figure 34: switch leon / leoni............................................................................................ 9-41 Figure 35: Replacement controllerboard leonplus ........................................................... 9-43 Figure 36: Replacement controllerboard leon .................................................................. 9-44 Figure 37: switch leon/leoni ............................................................................................ 9-44 Figure 38: Replacement NetDCU .................................................................................... 9-46 Figure 39: replacement backlight inverter ........................................................................ 9-48 Figure 40: replacement loud speaker............................................................................... 9-49 Figure 41: Replacement encoder..................................................................................... 9-50 Figure 42: replacement keypad........................................................................................ 9-51 Figure 43: rotameter block ............................................................................................... 9-53 Figure 44: adjusting knobs rotameter block ..................................................................... 9-54 Figure 45: Removing rotameter block .............................................................................. 9-54 Figure 46: rotameter block ............................................................................................... 9-55 Figure 47: adjusting knobs rotameter block ..................................................................... 9-55 Figure 48: Rotameter block without Plexiglas cover ........................................................ 9-56 Figure 49: AC/DC converter............................................................................................. 9-57 Figure 50: Selectatec vaporizer holder left and Dräger vaporizer holder right................. 9-59 Figure 51: loosen vaporizer holder................................................................................... 9-60 Figure 52: Position drilling jig ........................................................................................... 9-62 Figure 53: dismounted vaporizer block ............................................................................ 9-63 9-4

Heinen + Löwenstein, leonplus / leon Rev. 2.3.3

chapter 9: Repairs

Figure 54: Vaporizer holder.............................................................................................. 9-63 Figure 55: non-return valve .............................................................................................. 9-64 Figure 56: opened rear panel with Adapterboard, CFB and Mainboard .......................... 9-65 Figure 57: Protocol interface ............................................................................................ 9-69 Figure 58: mains connection board.................................................................................. 9-70 Figure 59: Aspiration AIR and VAC.................................................................................. 9-73 Figure 60: Gas box with aspiration AIR (Injector) ............................................................ 9-74 Figure 61: Gas box with aspiration VAC (Vacuum regulating valve) ............................... 9-74 Figure 62: Replace injector/Vacuum regulating valve...................................................... 9-75 Figure 63: Left: Connection tubes injector, Right: Connection tubes vacuum regulating valve ....................................................................................................................... 9-75 Figure 64: Parts injector ................................................................................................... 9-76 Figure 65: Connection aspiration AIR to connector block and exhaust air port ............... 9-77 Figure 66: tube system injector ........................................................................................ 9-77 Figure 67: Parts vacuum regulating valve........................................................................ 9-78 Figure 68: Connector block and NIST-connection ........................................................... 9-78 Figure 69: Tube system vacuum regulating valve............................................................ 9-79 Figure 70: Configuration option panel .............................................................................. 9-80 Figure 71: Rebuilding option panel leonplus .................................................................... 9-82 Figure 72: Rebuilding option panel leon .......................................................................... 9-82 Figure 73: Removing the option panel ............................................................................. 9-83 Figure 74: Tubing/Cabling option panel with O2 outlet .................................................... 9-83 Figure 75: Gas supply and non-return valve .................................................................... 9-84 Figure 76: Connection link plug on Actors-Connector-Board........................................... 9-84 Figure 77: Rebuilding option panel leonplus .................................................................... 9-85 Figure 78: Rebuilding option panel leon .......................................................................... 9-85 Figure 79: Removing option panel ................................................................................... 9-86 Figure 80: Tubing/Cabling option panel with fresh gas outlet .......................................... 9-86 Figure 81: Gas supply ...................................................................................................... 9-87 Figure 82: Link plug on Actors-Connector-Board............................................................. 9-87 Figure 83: Installation female connector workstation illumination .................................... 9-89 Figure 84: Connection supply line workstation illumination.............................................. 9-90 Figure 85: Assembling the optional workstation illumination............................................ 9-91 Figure 86: Lateral rail system........................................................................................... 9-91 Figure 87: Assembling mounting workstation illumination ............................................... 9-92 Figure 88: Assembling workstation illumination ............................................................... 9-92 Figure 89: Connection workstation illumination on socket rear panel .............................. 9-93

Heinen + Löwenstein, leonplus / leon Rev. 2.3.3

9-5

chapter 9: Repairs

Tables Table 1: components generator module .......................................................................... 9-14 Table 2: Label AION......................................................................................................... 9-20

9-6

Heinen + Löwenstein, leonplus / leon Rev. 2.3.3

chapter 9: Repairs

9.1

Opening rear panel Open the device while mains plug plugged in Danger of electrical shock

DANGER



Unplug the leon/leonplus from the mains power when opening and closing the device.

Electrostatic discharges in the device

Risk of damage to the device  CAUTION

  

All work on the device must be done on a suitable earthed and conductive work surface (antistatic, ESD protection). Make sure that you are sufficiently earthed (e.g. 1 MΩ). Earth every instrument used during work on the ventilator Transport components and printed-circuit boards in the correct antistatic packages only.

Required tools: 

Torx wrench (TX 20)

Turn off the device! Pull out the mains plug (A)!

A

Remove the screws (B) and open the rear panel (C). B

C

Figure 1: opening rear panel

Heinen + Löwenstein, leonplus / leon Rev. 2.3.3

9-7

chapter 9: Repairs

9.2 9.2.1

Replacement connector block/switch block required materials

required tools: 

Allen key (size 2,5 mm)



Torx wrench (TX 20)



Phillips screw driver

required material:



switch block (item no: 0209550)

OR 

9-8

BG connector block (item no: 0209501)

Heinen + Löwenstein, leonplus / leon Rev. 2.3.3

chapter 9: Repairs

9.2.2

Removing the gas box Device connected to gas supply Risk of damage to the device

CAUTION

 

Disconnect the device from gras supply Remove all gas cylinders connected to the device

Unscrew the vacuum adjusting knob to be able to remove the gas box Pull the gas box slightly forward. The gas box could not be removed completely until the cable and tube connections are connected. Disconnect the screws (D) on the rear panel of the gas box module. Pull the module out of the housing without disconnecting any tubes or cables.

D D Figure 2: Removing gas box

Heinen + Löwenstein, leonplus / leon Rev. 2.3.3

9-9

chapter 9: Repairs

9.2.3

Disconnecting tube and cable connections connector block

switch block

connector block

1

switch block 9

8

2

10

7 Molex connectors (7 pieces)

gas box leonplus Actors Connector Board connector block

6 11 12 3 4

13

5

gas box leon connector block leon and leonplus Figure 3: components gas box

In the appendix you may find a schematic of the tubing system gas box in different versions leon/leonplus. Procedure: 

Pull out the Molex-connectors at the top (7 pieces) off the Actors Connector Board. Mark the connectors and their position to prevent mistakes. The connectors on the side of the board should not be disconnected.



The following tubes should be replaced to be able to take the gas box completely out of the device:

9-10

o

connector block outlet drive gas (1) (red, 6 mm)

o

Flush to check valve vaporizer (2) (grey, 6 mm)

o

connector block OS out (3) (green, 4 mm)

o

connector block AM out (4) (black, 4 mm) Heinen + Löwenstein, leonplus / leon Rev. 2.3.3

chapter 9: Repairs

o

connector block HM out (5) (green, 6 mm)

o

O2 flow meter (6) (red, 6 mm) (if O2 flow meter is available)

o

Vacuum tube (7) (yellow, 6 mm)

only leonplus: o

switch block outlet carrier gas N2O/AIR (8) (red, 4 mm)

o

switch block outlet O2 (9) (grey, 6 mm)

o

switch block outlet emergency dosing (10) (grey or white, 6 mm)

only leon:



o

connector block outlet O2 (11) (grey, 6 mm)

o

connector block outlet N2O (12) (blue, 4 mm)

o

connector block outlet AIR (13) (black, 6 mm)

After removing all tubes, pull the gas box completely out off the device. Make sure to slightly lift the gas box.



To replace the connector block loosen two screws on the underside and two screws on the front side of the gas box (cross slot M3 x 10) attaching the connector block to the gas box.



To replace the switch block loosen two screws on the front side of the gas box (cross slot M3 x 10) attaching the switch block to the gas box.



Attach the new component accordingly in the gas box.



Place the gas box back in the device to be able to reconnect the tubes.



Reconnect all tubes and make sure that there are no interchanges (see Figure 3: components gas box)



At last, plug in the connectors on the Actors Connector Board. Make sure that there are no interchanges

a b c d e f g

a: AC/DC converter (Molex connector 4-pin, white housing) b: swing arm (Molex connector 8pin) c: Main board (50-pin ribbon cable) d: fan rear panel (Molex connector 3-pin) e: switch fresh gas (optional) (Molex connector 2-pin) f: Plateau valve, switch patient module (Molex connector 4pin) g: Mains connection board (Molex connector 6-pin)

Heinen + Löwenstein, leonplus / leon Rev. 2.3.3

9-11

chapter 9: Repairs Figure 4: Actors Connector Board



If you place the gas box back in position, be sure not to pinch any tube (Place tube (3), (4) and (5) in a loop around the connector block)



Screw the gas box back on the device with screws (D).



Screw the vacuum adjusting knob back on the front side of the device



Close the rear panel of the device.

9.2.4

Calibration procedures after replacement connector/switch block

After the replacement of the connector block the following calibrations are needed: 

7.6.5 Pilot pressure slide valves



7.6.6 Pilot pressure surplus diaphragm

After the replacement of the switch block the following calibrations are needed: 

7.6.4 Fresh gas blender inlet pressure (O2/AIR/N2O) – gas box Rev003

Therefore, follow the instructions in Service Manual, chapter 7 System Calibration.

9.2.5

Testing the gas box

After assembly and calibration the gas box has to be checked. Perform the following test items: 

8.7.1 fresh gas system tightness leonplus respectively 8.7.2 fresh gas system tightness leon



8.14.5 Vacuum injector and vacuum meter test



8.20 Function test of nitrous oxide gas lock (only leonplus)

Therefore, follow the instructions in Service Manual, chapter 8 Tests.

9-12

Heinen + Löwenstein, leonplus / leon Rev. 2.3.3

chapter 9: Repairs

9.3

Replacement generator module The replacement generator module differs between the devices leonplus and leon.

9.3.1

Required materials

Required tools: 

Socket wrench (size 5.5 mm)



Allen key with ball head (size 4 mm)

Required material: 

Generator module leonplus (item no: 0208740)

OR 

Generator module leon (item no: 0208740-1)

Components leonplus

9.3.2 B

B

14 2

2

5

A

6 3

7

4

13

5

13

6

3

14

7

15

15

A B

1

1 B 8 10

9

11

12

10

8

9

11

12

Figure 5: generator module leonplus (left) / leon (right)

Figure 5 shows the generator module in two revisions. Left: Fresh gas blender board and drive gas generator board are located on two separate boards. Right: Both boards are combined on one board (Rev.301). Position of pressure sensor drive gas inlet pressure (8) and airway pressure measurement (9) are interchanged for both revisions. Nr. 1 2 3

description leonplus Fresh gas blender Drive gas generator Fresh gas blender board resp. combined blender board (Rev. 301) Heinen + Löwenstein, leonplus / leon Rev. 2.3.3

9-13

chapter 9: Repairs

4 5 6 7 8 9 10 11 12 13 14 15 A B

Drive gas generator board, below fresh gas blender board O2- fuel cell fresh gas with cable Ribbon cable from Mainboard to fresh gas and drive gas generator board Tube inlet drive gas generator (6 mm, red) Tube to pressure sensor inlet pressure drive gas (6 mm, red) Tube to pressure sensor airway pressure measurement (6 mm, transparent) Tube outlet drive gas generator (10 mm, transparent) Tube inlet fresh gas blender N2O / Air (4 mm, red) Tube inlet fresh gas blender O2 (6 mm, grey) Tube from emergency dosing (6 mm, grey) Tube outlet fresh gas blender (Teflon, transparent) Strap for rear panel Nuts for fixation fresh gas blender board (5.5 mm) (4 pieces) Screws for fixation generator module (4 mm Torx) (4 pieces) Table 1: components generator module

9.3.3

Procedure leonplus



Open the rear panel of the device



Plug out the ribbon cable (6) You have to loose the nuts (A) to be able to disconnect the ribbon cable (Revision with separate fresh gas and drive gas boards)

Loose nuts (A) to be able to plug out the lower connector

Figure 6: ribbon cable to fresh gas blender and drive gas generator board



Plug out the cable of the O2 fuel cell and unscrew the O2 fuel cell (5)



Loosen the tube inlet drive gas generator (7) at the T-piece, not directly at the drive gas generator.



Loosen the tube to pressure sensor inlet pressure drive gas (8)



Loosen the tube to pressure sensor airway pressure measurement (9)

Figure 7 shows the revision with separate fresh gas and drive gas generator boards. The procedure is the same for both revisions. Notice different position of the pressure sensors!

9-14

Heinen + Löwenstein, leonplus / leon Rev. 2.3.3

chapter 9: Repairs

Tube to pressure sensor inlet pressure drive gas (8) Tube to pressure sensor airway pressure measurement (9) Outlet drive gas generator (10) Figure 7: Pressure sensors on drive gas generator board

The tube to pressure sensor inlet pressure drive gas (8) (6 mm, red) is difficult to loosen. Therefore, you can use the attached tube (6mm, red). Cut it to the appropriate length. 

Loosen the tube outlet drive gas generator (10) directly at the drive gas generator



Loosen the tube inlet fresh gas blender AIR/N2O (11) directly at the fresh gas blender



Loosen the tube inlet fresh gas blender O2 (12) directly at the fresh gas blender



Loosen the tube emergency dosing to fresh gas blender (13) directly at the fresh gas blender



Loosen the tube outlet fresh gas blender (14)



Loosen screws (B) to remove the generator module. The strap for the rear panel (15) is attached with the screw in the upper right corner.

Make sure that the back panel will not fall down during disassembling. 

Reassemble generator module according to this instruction in reverse order.



Make sure that all tubes and cables are connected correctly

Notice the transposition of the two pressure sensors depending on revision. 

Make sure that all connections are leak-proof.

Heinen + Löwenstein, leonplus / leon Rev. 2.3.3

9-15

chapter 9: Repairs

9.3.4

Components leon

A

A

1

3

2 4

8 A 6 5

7

A Figure 8: generator module leon

Figure 8 shows the generator module with the older version blender board. Description leon Drive gas generator Drive gas generator board Ribbon cable from Mainboard to drive gas generator board Tube inlet drive gas generator (6 mm, red) Tube to pressure sensor drive gas inlet pressure (6 mm, red) Tube to pressure sensor airway pressure measurement (6 mm, transparent) Tube outlet drive gas generator (10 mm, transparent) Strap rear panel Screws for fixation generator module (4 mm Torx) (4 pieces)

No 1 2 3 4 5 6 7 8 A

9.3.5

Procedure leon



Open the rear panel of the device



Plug out the ribbon cable (3)



Loosen the tube inlet drive gas generator (4) at the T-piece, not directly at the drive gas generator.



Loosen the tube to pressure sensor inlet pressure drive gas (5)



Loosen the tube to pressure sensor airway pressure measurement (6)

9-16

Heinen + Löwenstein, leonplus / leon Rev. 2.3.3

chapter 9: Repairs

Tube to pressure sensor inlet pressure drive gas (5)

Tube to pressure sensor airway pressure measurement (6) Outlet drive gas generator (7) Figure 9: Pressure sensors on drive gas generator board

Figure 9 shows the old revision of the drive gas generator board. Position of the pressure sensors are interchanged for the new revision (Rev. 301)! The tube to pressure sensor inlet pressure drive gas (5) (6 mm, red) is difficult to loosen. Therefore, you can use the attached tube (6mm, red). Cut it to the appropriate length. 

Loosen the tube outlet drive gas generator (7) directly at the drive gas generator



Loosen screws (B) to remove the generator module. The strap for the rear panel (8) is attached with the screw in the upper right corner.

Make sure that the back panel will not fall down during disassembling. 

Reassemble generator module according to this instruction in reverse order.



Make sure that all tubes and cables are connected correctly

Notice the transposition of the two pressure sensors depending on revision. 

Make sure that all connections are leak-proof.

Heinen + Löwenstein, leonplus / leon Rev. 2.3.3

9-17

chapter 9: Repairs

9.3.6

Calibration after replacement generator module

The following calibrations are needed after reassembling the new generator module: leonplus: 

7.6.4 Fresh gas blender inlet pressure



7.6.7 Hardware calibration for airway pressure measurement



7.6.8 Hardware calibration of inlet drive gas generator



7.6.9 Hardware calibration of fresh gas flow monitor

 leon: 

7.6.7 Hardware calibration for airway pressure measurement



7.6.8 Hardware calibration of inlet drive gas generator

Therefore follow the instructions in Service Manual chapter 7 System Calibration, 7.6 Hardware calibration.

9.3.7

Testing generator module

The generator module has to be tested on functioning. Perform the following test items: leonplus: 

8.7.1Fresh gas system tightness leonplus



8.7.8 Testing the drive gas generator



8.7.9 Fresh gas valve test



8.9 Fresh gas blender total flow test



8.16 Testing airway pressure measurement



8.19 Functional test of fresh gas blender (overall function)

leon: 

8.7.8 Testing the drive gas generator



8.16 Testing airway pressure measurement

Therefore, follow the instruction in Service Manual, chapter 8 Testing.

9-18

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chapter 9: Repairs

9.4

Replacement gas measurement

Gas measurement is located in the lower right corner if the rear panel is opened. It is available in several versions and does not need to be replaced completely in any case. The three main components AION, Servomex, and water trap receptacle can be replaced separately. If you replace AION 01 (green), AION 02 (orange) or AION 03 (red), follow the instruction in chapter 9.4.1 Replacement gas measurement AION 01/AION 02/AION 03. If you replace Servomex, follow the instruction in chapter 9.4.2 Replacement Servomex oxygen measurement. If you replace Oxima, follow the instruction in chapter 9.4.3 Replacement Oxima oxygen measurement cell. If you replace water trap receptacle, follow the instruction in chapter 9.4.4 Replacement water trap receptacle. Figure 10 shows the arrangement of the gas measurement in leonplus. In leon the Servomex is located above AION, but connections are the same.

2

1

4

5

No. 1 2 3 4 5 6

3

6

Description AION (red, orange or green) Servomex oxygen measurement (optional) Ribbon cable to AION Cable to Servomex oxygen sensor Screws for attachment AION Screws for attachment Servomex oxygen measurement

Notice that the screws have different lengths. This is important during reassembling later! Figure 10: gas measurement AION 03 with Servomex (leonplus)

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

9-19

chapter 9: Repairs

Table 2: Label AION

9.4.1

Replacement gas measurement AION 01/AION 02/AION 03

Depending on configuration of gas measurement, replacement procedure varies. Configuration gas measurement Gas measurement with Servomex oxygen measurement Gas measurement with Oxima oxygen measurement Gas measurement without integrated oxygen measurement 9.4.1.1

Instruction Section 9.4.1.2 Section 9.4.1.3. Section 9.4.1.4

Required material

Required tools: 

Phillips screw driver

Required material: 

AION 03 Multigas Analyzer (item no.: 0208620)

OR 

AION 02 Multigas Analyzer (item no.: 0208621)

OR 

AION 01 CO2-Analyzer (item no:0208619)

ADDITIONAL: 

Sample gas return (item no: 0208626, quantity: 0,22 m)



Short circuit O2 measurement (item no: 0208625, quantity: 0,07 m)

9-20

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chapter 9: Repairs

9.4.1.2

Version 1: AION 01/02/03 with Servomex oxygen measurement

water trap AION

7 Servomex

11

8 9 10

Figure 11: AION with Servomex oxygen measurement and water trap

AION with Servomex oxygen measurement: 

Plug out the cable to the AION (3) (see Figure 10)



Plug out the cable to the Servomex oxygen measurement (4)



Loosen the tubes from water trap to AION (7 + 8) (see Figure 11)



Loosen the sample gas return at the AION (9)



Loosen the tubes from Servomex to AION (10 + 11)



Loosen the two screws at the AION (5) and take the AION out of the device (see Figure 10)



Screw the new AION on the device. Notice that the screws have different lengths.



Reconnect the tubes according to Figure 11. Use therefore the supplied tubes. The tube short circuit oxygen measurement is not needed!



Plug in the cable Servomex oxygen measurement (4)



Last, plug in the cable AION (3).



Perform the needed calibrations (see section 9.4.5 Calibration )



Test the gas measurement on functioning (see section 9.4.6 Testing the gas measurement)

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

9-21

chapter 9: Repairs

9.4.1.3

Version 2: AION 01/02/03 with Oxima oxygen measurement

AION

water trap

8 7

10

sample gas return

11 9

Oxima

Figure 12: AION and water trap with Oxima oxygen measurement

AION with Oxima fuel cell oxygen measurement: 

Plug out the cable to the AION (3) (see Figure 10)



Loosen the tubes from water trap to AION (7 + 8) (see Figure 12)



Loosen the sample gas return at the AION (9)



Loosen the tubes from Oxima fuel cell to AION (10+11)



Loosen the two screws at the AION (5) (see Figure 10)



Take the AION out of the device



Screw the new AION on the device. Notice, that the screws have different lengths!



Reconnect the tubes according to Figure 12. Use therefore the supplied tubes. The tube short circuit oxygen measurement is not needed



Plug in the cable to AION (3).



Perform the needed calibrations (see section 9.4.5 Calibration )



Test the gas measurement on functioning (see section 9.4.6 Testing the gas measurement)

9-22

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chapter 9: Repairs

9.4.1.4

Version 3: AION 01/02/03 without integrated oxygen measurement

water trap AION 7

8

9

Figure 13: AION with water trap

Device without integrated oxygen measurement: 

Plug out the cable to the AION (3) (see Figure 10)



Loosen the tubes from water trap to AION (7 + 8) (see Figure 13)



Loosen the sample gas return at the AION (9)



Loosen the two screws attaching AION (5) (see Figure 10)



Take the AION out of the device



Screw the new AION on the device. Notice, that the screw have different lengths



Reconnect tubes according to Figure 13.



The inlet and outlet oxygen measurement of the AION has to be short circuit.



Plug in the cable AION (3).



Perform the needed calibrations (see section 9.4.5 Calibration )



Test the gas measurement on functioning (see section 9.4.6 Testing the gas measurement)

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

9-23

chapter 9: Repairs

9.4.2

Replacement Servomex oxygen measurement

9.4.2.1

Required materials

Required tools: 

Phillips screw driver

Required material: 

Servomex (item no.: 0208634)



AION O2 Buffer (item no.: 0208650)



Y-piece with tubes (item no: 0208627)

9-24

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

chapter 9: Repairs

9.4.2.2

Servomex oxygen measurement

water trap AION

Servomex

8

7

Figure 14: AION with Servomex oxygen measurement and water trap

Replacement procedure Servomex oxygen measurement: 

Plug out the cable AION (3) (see Figure 10)



Plug out the cable Servomex oxygen measurement (4)



Loosen the tubes from Servomex to AION (7 + 8) (see Figure 14)



Loosen the two screws on Servomex (6) and take the Servomex out of the device (see Figure 10)



Screw the new Servomex on the device.



Reconnect all tube connections according to Figure 14. Use therefore the supplied tubes.



Plug in the cable Servomex oxygen measurement (4) (see Figure 10).



Plug in the cable AION (3).



Perform the needed calibrations (see section 9.4.5 Calibration gas measurement)



Test the gas measurement on functioning (see section 9.4.6 Testing the gas measurement)

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

9-25

chapter 9: Repairs

9.4.3

Replacement Oxima oxygen measurement cell

9.4.3.1

Required material

Required tools: 

Coin or the like

Required material:  9.4.3.2

Oxima oxygen measurement cell (item no: 0208622) Oxima oxygen sensor



Switch on leon/leonplus



Start ventilation with 21 % oxygen for at least 2 min



Stop ventilation



Take the water trap out of its receptacle



Remove the Oxima oxygen measurement cell by turning the cell 90° clockwise with a coin or the like

Figure 15: Remove Oxima oxygen measurement cell



9-26

Place the new Oxima measurement cell into position

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

chapter 9: Repairs

9.4.3.3

Calibration Oxima oxygen sensor

Gain calibration is automatically done when the water trap is installed 



Perform a pressure calibration (described below) o

Connect the measurement tube to the water trap LuerLock connection

o

The measurement tube may not be connected to the Y-piece

o

Install the water trap in the receptacle

Perform a span calibration (see chapter 7.8.2.3 Span-Calibration O2-sensor) A restart of the device is needed after calibration!

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

9-27

chapter 9: Repairs

9.4.4

Replacement water trap receptacle

The water trap receptacle is located on the option panel or on the left side of the housing.

Figure 16: Position water trap receptacle

There are two versions of water trap receptacles available depending on kind of oxygen measurement. Follow the replacement instruction in the according sections: Water trap receptacle differs on kind of oxygen measurement!

attachment screws Oxima oxygen fuel cell Oxygen measurement without Oxima 9.4.4.2 Version 1: water trap receptacle

Oxygen measurement with Oxima 9.4.4.3 Version 2: water trap receptacle with Oxima fuel cell

Figure 17: water trap receptacle and water trap receptacle with Oxima

9.4.4.1

Required materials

Required tools: 

Torx screw driver (TX 6)

Required material: 

water trap receptacle (item no.: 0208635)

OR Service Kit water trap receptacle Oxima (item no: 0209092) consisting of: 

water trap receptacle with Oxima (item no.: 0208623)



water trap Oxima fuel cell (item no.: 0208622)

9-28

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chapter 9: Repairs

9.4.4.2

Version 1: water trap receptacle

water trap AION 1 Servomex

2

Figure 18:AION with water trap receptacle

Water trap receptacle without Oxima: 

Loosen the tubes from water trap to AION (1 + 2) directly at the AION



Loosen both attachment screws at the water trap receptacle (see Figure 17) and take the water trap receptacle out of the device.



Screw the new water trap receptacle on the device. Make sure, that no tube is pinched.



Reconnect tubes according to Figure 18



Perform the needed calibrations (see section 9.4.5 Calibration gas measurement)



Test the gas measurement on functioning (see 9.4.6 Testing the gas measurement)

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

9-29

chapter 9: Repairs

9.4.4.3

Version 2: water trap receptacle with Oxima fuel cell

AION

water trap

2 1

3

sample gas return

4

Oxima

Figure 19: AION with water trap receptacle Oxima fuel cell

Water trap receptacle with Oxima fuel cell: 

Loosen the tubes water trap to AION (1 + 2)



Loosen the tubes from Oxima fuel cell to AION (3 + 4)



Take the water trap receptacle out of the device by loosening the two attachment screws (see Figure 17)



Screw the new water trap receptacle on the device. Make sure that no tube is pinched.



Reconnect the tubes according to Figure 19.



Follow section 9.4.3 Replacement Oxima oxygen measurement cell for installation of the oxygen measurement cell.



Place the Oxima oxygen sensor in the receptacle and perform calibration (see section 9.4.5 Calibration )



Test the gas measurement on functioning (see section 9.4.6 Testing the gas measurement)

9-30

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chapter 9: Repairs

9.4.5

Calibration gas measurement

After assembling the gas measurement, it has to be tested to tightness. Perform the following test item: 

8.17.1 Gas measurement leakage test

Then the gas measurement has to be calibrated. Perform the following test items in the according order: Replacement Servomex: 

7.8.3 Calibration Servomex O2-Sensor

consisting of: 

7.8.3.2

21% Calibration Hardware



7.8.3.3

100% Calibration Hardware



7.8.3.1

Calibration flow sensitivity

Replacement Servomex and Oxima oxygen sensor: 

7.8.2.3 Span-Calibration O2-sensor

Follow the instruction in Service Manual chapter 7.8 Calibration of the gas monitor (Artema AION).

9.4.6

Testing the gas measurement

After replacement a component of the gas measurement it has to be tested on functioning. Perform the following test items: 

8.17 Gas measurement test (SERVOMEX/OXIMA/AION/IRMA)



8.18 O2 monitor test

Follow the instruction in Service Manual, chapter 8 Tests and note the performed test items in the test log!

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

9-31

chapter 9: Repairs

9.5 9.5.1

Replacement Front module Replacement Display leonplus

9.5.1.1

Required materials

Required tools: 

crosshead screw driver



Torx screw driver (TX20)



jaw wrench (size 12 mm)



allen key (size 1,5 mm)

Required material:  9.5.1.2

Front module leonplus (item no: 0209660bg) Disassembling display leonplus



Open the rear panel of the device



Disconnect the cables (1) – (4) to controllerboard



Pull the cables out of the cable holders (5) attached to the front module. 5 4

1: cable Adapterboard (X14) 3

2: cable AION (X24), if available 3: Ethernet network cable 4: cable Protocol Interface

2

5: cable holder 5

6: holding plate AION

1 6

Figure 20: rear view leonplus



If the device is equipped with gas measurement AION, open the panel (7) of the rear panel (see Figure 21)

9-32

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

chapter 9: Repairs

7

A

Figure 21: Open panel rear side leonplus



Loosen the four screws (A) on the rear side of the device.



Loosen the holding plate (6) AION. You reach screws (B) through the cover on the opened rear panel.

6

B Figure 22: Removing the holding plate AION (picture leon)



Loosen screws (B) only far enough to reach screws (C) of the front module (see Figure 23).



Loosen screws (C) of the front module at the housing.

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

9-33

chapter 9: Repairs

Figure 23 only shows the front module attached to the housing leonplus, all other components, cables and tubes were removed. C

8

11

8: front module 9: switch leon/leoni

9

15

10: NetDCU 14

11: cable LCD 15“ (X11) 12 cable encoder (X25) D

D

C

13: cable keypad (X18) C 14: cable touch (X13) 15: cable backlight inverter (CN2/CN3)

10

16: cable backlight inverter 16

12 17

13

(CN4/CN5) 17: encoder

C Figure 23: Front module leonplus



Take the front module (8) carefully out of the device and place it on a stable, ESDproof surface.



Loosen cables (11) – (16) to the controllerboard.



Loosen screws (D) and remove the controllerboard.



There are two display revisions available. If you replace the display, you will get the newer revision 4 of the display.



Modifications of revision 3 to revision 4: (Figure 24) o

The touch was turned 180° and therefore the touch cable (1) can be found on the opposite side.

o

An additional board (2) with touch cable extension (3) is necessary to be able to connect the touch cable on the controller board.

o

This addition board is attached to the new display plate (4).

o

There are longer distance pieces needed to connect the controllerboard (white, snap-in) (5)

o

Lay the touch cable extension behind the controller board and connect it on the opposite side to the controller board.



9-34

Other components and connections were not changed.

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

chapter 9: Repairs

4

2

1

1

3

Revision 3

5

Revision 4

Figure 24: Differences display revision 3 to display revision 4



Attach the new distance pieces (5) to the display plate (4) at the attachment points of the controllerboard.



Attach the controllerboard to the display by snapping the controllerboard on the new distance pieces (5)



Do not twist the cable behind the controller board.

E

F 1

2

Figure 25: remove rotary pulse encoder



Loosen the wheel (1) on the keypad by loosening the screw (E).



Loosen rotary pulse encoder (2) by loosening nut (F).



Attach the rotary pulse encoder accordingly to the new display.



Reconnect the cable connections (11) – (16) according to Figure 23.



Place the new front module back in the device and attach it with screws (C).



Make sure, that no cables are pinched!



Attach the holding plates AION with screws (B).

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

9-35

chapter 9: Repairs



Reconnect the cables to the controllerboard (see Figure 20) o

Adapterboard (1) (X14)

o

AION (if available) (2) (X24)

o

Ethernet network cable (3)

o

Protocol Interface (4) (X21)



Place the cables back in the cable holders (5) (see Figure 20)



Pay attention, that the switch (9) is switched to leon and not leoni

9

Switch leon/leoni placed in the upper right corner of the Controllerboard

Figure 26: switch leon / leoni

9.5.1.3

Test after replacement display leonplus

After the replacement of the display the following tests must be performed: 

8.13 Testing the electronic control and display elements o

8.13.1 Keypad test

o

8.13.2 Display test

o

8.13.3 LED test

o

8.13.4 Sound test

o

8.13.5 Testing the touch screen

Therefore follow the instruction in Service Manual, chapter 8. Tests.

9-36

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

chapter 9: Repairs

Replacement Display leon

9.5.2 9.5.2.1

Required materials

Required tools: 

Phillips screw driver



Torx-screw driver (TX20)



Allen key (size 1,5 mm, 2,5 mm, 3 mm)



Jaw wrench (size 7 mm, 12 mm)

Required material:  Front module leon (item no: 0209650bg) resp.  Front module leon new (item no: 0209322hul100bg) Disassembling display leon

9.5.2.2 

Open the rear panel of the device



Disconnect cables (1) – (5) to the controllerboard



Pull the cables out of the cable holders (6) attached to the front module. The controllerboard leon is turned 90° clockwise compared to leonplus.

5

2

1: cable Adapterboard (X14) 2: cable AION (X24), if

6

available

6

3: Ethernet network cable, if

4

available 4: cable Protocol Interface

1

(X21), if available

3

5: backlight rotameter block 5

(X17) 6: cable holder

Figure 27: rear view leon



If the device is equipped with a gas measurement AION, remove the cover (7) of the rear panel

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

9-37

chapter 9: Repairs

7

A

Figure 28: Removing cover rear view leon



Therefore, loosen the four screws (A) on the rear side of the device.



Loosen the holding plate (8) AION. You reach the screws (B) through the removed cover of the rear panel.

8

B Figure 29: Removing holding plates AION (picture leon)



Loosen screws (B) only far enough to be able to loosen screws (C) of the front module (Figure 30).



Loosen the rotameter block (9). For more information see chapter 9.6.2 Disassembling rotameter block. Notice the different kinds of attachment of the rotameter block.



9-38

Loosen the screws (C) (see Figure 30) of the front module attached to the housing

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

chapter 9: Repairs

Figure 30 shows only the front module attached to the housing leon, all other cables and tubes were removed. C

10

D

9: rotameter block D

16

10: front module

9

11: NetDCU

17

12: cable LCD 12“ (X8) 13: cable rotary pulse encoder (X25)

11

C

14: cable keypad (X18)

14 12

D

15: cable touch (X13) 16: cable backlight inverter

D

18 13

C

(JP2) 17: cable backlight inverter (JP3)

15 19

C hided by AION

18: switch leon/leoni

Figure 30: Front module leon with rotameter block



Take the front module (10) carefully out of the device and place it on a stable, ESDproof surface.



Loosen cables (12) – (17) of the controllerboard



Loosen screws (D) and remove the controllerboard

There are two versions of the front module available. The following differences exist between the versions (see Figure 31 and Figure 32): 

Old: There is a distance between frame and touch/display (1) New: The frame of the front module does not have a distance to the touch/display (2).



Old: The keypad is placed below the display (3). New: The keypad was increased and surrounds the touch (4).



Old: The display is attached to the front module by two rails (5). The controllerboard is connected to the distance pieces (6) by screws. New: The display plate covers the display to the back (7). The controllerboard is connected to this plate by snap-in distance pieces (8).



Old: The rotameter block is attached from the back by holding plates (9). New: The rotameter block can be attached from the front of the front module if the rotameter block has the corresponding drills (10). A mounting from the back is still possible.

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

9-39

chapter 9: Repairs

old

new

10

10

9 3 10

4

10

1 2

Figure 31: Front view front module leon Version old, Version new

6

old

new

6

8

8

5

7

6 5 6

8 8

Figure 32: Rear view front module leon Version old, Version new

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chapter 9: Repairs



Attach the controllerboard to the distance pieces.

E

F 19

20

wheel

keypad leon

rear side leon

Figure 33: Replacement rotary pulse encoder



Loosen the rotary pulse encoder (20) on the keypad by loosening screw (E)



Loosen the rotary pulse encoder (19) by loosening the nut (F)



Attach the rotary pulse encoder accordingly to the new display



Reconnect the cable connections (12) – (17) according to Figure 30



Place the new front module in position and screw it with screws (C) on the housing.



Make sure, that no cables are pinched!



Attach the rotameter block (9) to the front module.



Screw the holding plates AION with screws (B) on the device.



Reconnect cables to Controllerboard (see Figure 27) o

Adapterboard (1)

o

AION (if available) (2)

o

Ethernet network cable (3)

o

Protocol Interface (4)

o

background lightning rotameter block (5)



Place the cables back into the cable holders (6)



Make sure, that the switch (12) is switched to leoni and not to leon

12

Switch leon/leoni placed in the right upper corner controllerboard

Figure 34: switch leon / leoni

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chapter 9: Repairs

Testing after replacement display leon

9.5.2.3

After calibrating the front module, it has to be checked on functioning. Perform the following test items: 

8.7.10 Test of rotameter block



8.13 Testing the electronic control and display elements o

8.13.1 Keypad test

o

8.13.2 Display test

o

8.13.3 LED test

o

8.13.4 Sound test

o

8.13.5 Testing the touch screen

Follow the instruction in Service Manual, chapter 8. Tests!

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chapter 9: Repairs

Replacement controllerboard leon/leonplus

9.5.3 9.5.3.1

Required materials

Required tools: 

Phillips screw driver



Allen key (size 2.5 mm)

Required material: 

Controllerboard (item no: 0208707)

9.5.3.2

Replacement controllerboard



Open the rear panel of the device



The controllerboard is placed on the rear side of the display 9

10

8

4

A

A

1

6

11

C B 3

B

2

14

A

A 7

12

13

1: Controllerboard 2: NetDCU 3: Backlight Inverter 4: Network cable 5: Adapterboard (X14) 6: AION (X24) (if available) 7: Backlight Inverter (CN4/CN5) 8: Backlight Inverter (CN2/CN3) 9: Protokoll Interface (X21) 10: LCD 15” (X11) 11: Touch (X13) 12: Keypad (X18) 13: Encoder (X25) 14: Backlight Inverter (CN1)

5

Figure 35: Replacement controllerboard leonplus

15

A

A

6

C

7

3

13

8

14

9

5

4

B 2

1

12

A A

B

11

10

1: Controllerboard 2: NetDCU 3: Backlight Inverter 4: Network cable 5: Adapterboard (X14) 6: AION (X24) (if available) 7: Backlight Inverter (JP2) 8: Backlight Inverter (JP3) 9: Protokoll Interface (X21) 10: LCD 12” (X8) 11: Touch (X13) 12: Keypad (X18) 13: Encoder (X25) 14: Backlight Inverter (JP1) 15: backlight rotameter block (X17)

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

9-43

chapter 9: Repairs Figure 36: Replacement controllerboard leon

The controllerboard leon is turned 90° clockwise compared to leonplus. The replacement procedure does not differ in leon/leonplus. 

Loosen cable (4) – (14) respectively (4) – (15) to the controllerboard



Loosen screws (A)



Remove the controllerboard (1) carefully and place the board on an ESD-proof surface.



The new controllerboard is delivered without NetDCU and Backlight Inverter. These should be taken of the old board.



Loosen screws (B) and take the NetDCU (2) out of the device. The board may not be screwed up or twisted because the components could be damaged! Remove also the distance pieces.



Loosen screws (C) and take the backlight inverter (3) out of the device. Remove also the distance pieces.



Attach both boards to the new controllerboard with screws (B) and (C) and the according distances pieces.



Attach the controllerboard to the display with screws (A)



Reconnect cables (4) – (14) respectively (4) – (15) Device

switch setting

leonplus

leon

leon

leoni

Switch leon/leoni in the upper right resp. lower right corner of the controllerboard Figure 37: switch leon/leoni



Make sure that the switch is set correctly



Close the rear panel of the device

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chapter 9: Repairs

9.5.3.3

Test after replacement controllerboard

The following tests are necessary after the replacement of the controllerboard: 

8.13.4 Sound test

Follow the instruction in Service Manual, chapter 8.Tests Replacement controller board inclusive NetDCU Risk of malfunction CAUTION

 

Follow instructions in chapter 9.5.4.3 Calibration Follow instruction in chapter 9.5.4.4 Test after replacement NetDCU

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9-45

chapter 9: Repairs

9.5.4

Replacement NetDCU leon/leonplus

9.5.4.1

Required materials

required tools: 

Allen key (size 2.5 mm)

Required material: 

NetDCU (item no: 0209663)

9.5.4.2

Replacement NetDCU



Open the rear panel of the device



The NetDCU is placed on the controllerboard Figure 38 shows the setting in leonplus. In leon the controllerboard is turned 90° clockwise.

1: Controllerboard 2: NetDCU

A 1

2

A

Figure 38: Replacement NetDCU



Loosen screws (A)



Replace the NetDCU (2). The connectors are difficult to loosen. The board may not be screwed up or twisted because the components could be damaged!



The distance pieces under the NetDCU may not be removed



Connect the new NetDCU and attach it with screws (A)



After the replacement of the NetDCU there is a software update needed. Follow the instruction in Service Manual, chapter 5. Update system software.

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chapter 9: Repairs

9.5.4.3

Calibration after replacement NetDCU

After the replacement of the NetDCU there is the following calibration needed: 

7.7.4 Calibration pressure sensor

Follow the instruction in Service Manual, chapter 7. Calibration procedure

9.5.4.4

Test after replacement NetDCU

After the replacement of the NetDCU there is the following test needed: 

8.16 Testing airway pressure measurement

Follow the instruction in Service Manual, chapter 8. Testing

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chapter 9: Repairs

Replacement backlight inverter leon/leonplus

9.5.5 9.5.5.1

Required material

Required tools: 

Phillips screw driver

Required materials: 

backlight inverter leonplus (item no: 0209662)

OR 

backlight inverter leon (item no: 02117761)

9.5.5.2

Replacement backlight inverter



Open the rear panel of the device



The backlight inverter is placed on the controllerboard Figure 39 shows the setting in leonplus. The controllerboard is turned 90° clockwise in leon.

5 1 3

A 2

1: Controllerboard 2: Backlight Inverter 3: connector CN1 resp. connector JP1 4: connector CN2/CN3 resp. connector JP2 5: connector CN4/CN5 resp. connector JP3

4

Figure 39: replacement backlight inverter



Loosen cables (3) – (5)



Loosen screws (A)



Remove the backlight inverter (2) carefully from the controllerboard (1). The distance pieces may not be removed.



Attach the new backligt inverter on the controllerboard with screws (A)



Reconnect cables (3) - (5)

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chapter 9: Repairs

Replacement loudspeaker leon/leonplus

9.5.6 9.5.6.1

Required materials

Required tools: 

Allen key (size 2.5 mm)



Crosshead screw driver

Required material: 

Loudspeaker (item no: 0208732)

9.5.6.2

Replacement loud speaker



Open the rear panel of the device



The loudspeaker is placed on the controllerboard Figure 39 shows the setting in leonplus. The controllerboard is turned 90° clockwise in leon.

B

3

1

A

A

1: controllerboard 2: loudspeaker 3: cable loudspeaker A: Allen screw B: cross slot screw

B 2

Figure 40: replacement loud speaker



Loosen connector (3) on the controllerboard



Loosen screws (A)



Take the loudspeaker (2) with holding plate out of the device



The distance pieces may not be replaced



Loosen screws (B) and take the loudspeaker out



Attach the new loudspeaker with screws (B)



Attach the holding plate with screws (A) and reconnect cable (3)

9.5.6.3

Test after replacement loudspeaker

After the replacement of the loudspeaker the following test needs to be performed: 

8.13.4 Sound test

Follow the instruction in Service Manual, chapter 8. Testing Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

9-49

chapter 9: Repairs

9.5.7

Replacement rotary pulse encoder

9.5.7.1

Required materials

Required tools: 

Jaw wrench (size 12 mm)



Allen key (size 1.5 mm)

Required material: 

rotary pulse encoder (item no: 0208731hul002)



wheel (item no: 0217041-1)

9.5.7.2

Replacement encoder



Open the rear panel of the device



The rotary pulse encoder is placed on the front module 1

B

A 2

1: keypad 2: wheel 3: rotary pulse encoder 4: connector on controllerboard

4

A: Allen screw (1.5 mm) B: nut (12 mm) 3 Figure 41: Replacement encoder



Remove the wheel (2) by loosening the Allen screw (A)



Loosening nut (B)



Loosen the cable to the controllerboard (4)



Take the rotary pulse encoder (3) out of the device



Reassemble the components in reverse order

9.5.7.3

Test after replacement encoder

After the replacement of the encoder the following test should be performed: 

8.13.1 Testing the electronic control and display elements

Follow the instruction in Service Manual, chapter 8. Testing 9-50

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chapter 9: Repairs

Replacement keypad leon/leonplus

9.5.8 9.5.8.1

Required materials

Required tools: 

Allen key (size 1.5 mm)

Required material: 

keypad leonplus (item no: 0080410)

OR 

keypad leon (item no: 0080400) The keypad cannot be replaced separate on new front module leon (item no. 0209322hul100bg).

9.5.8.2

Replacement keypad



Open the rear panel of the device



The keypad is connected to the controllerboard Figure 39 shows the setting in leonplus. The controllerboard is turned 90° clockwise in leon.

1

3

A 2

1: Keypad 2: Controllerboard 3: wheel 4: cable keypad 4

A: Allen key screw

Figure 42: replacement keypad



Loosen the rotary knob (3) by loosening the Allen screw (A)



Loosen the connector (4) on the controllerboard (2). In leon the cable is more difficult to loosen due to the rotation of the controllerboard. Make sure not to disconnect other cables. It could be necessary to remove the controllerboard

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chapter 9: Repairs



Pull the keypad (1) off



Insert the cable of the new keypad through the opening in the front module



Adhere the new keypad and reconnect the cable on the controllerboard The keypad can only be stuck once.

9.5.8.3

Test after replacement keypad

After the replacement of the keypad the following tests should be performed: 

8.13.1 Keypad test

Follow the instruction in Service Manual, chapter 8. Testing

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chapter 9: Repairs

9.6

Replacement rotameter block

9.6.1

Required materials

Required tools: 

Phillips screw driver



Allen key (2.5mm, 3mm, 4mm)



Jaw wrench (7mm)

Required material: 

Rotameter block leon 5x (item no: 0208800BG)

OR 

Rotameter block leon 3x (item no: 0208800-1BG)

9.6.2

Disassembling rotameter block

There exist two kinds of attachment of the rotameter block. Follow the instruction in the corresponding section. Attachment by holding plates from the back of the front module: The rotameter block is attached to the housing by holding plates. 

Open the rear panel of the device. 4



5



Loosen the tubes at rotameter block o

AIR (1) (6mm, black)

o

N2O (2) (4mm, blue) (if available)

o

O2 (3) (6mm, grey)

o

fresh gas (4) (Teflon, transparent)

Loosen the cable for backlight of the rotameter block (5)

3 1

2

Figure 43: rotameter block



Loosen the adjusting knobs on the front side of the rotameter block by loosening the threaded pins (A).

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9-53

chapter 9: Repairs

A

Figure 44: adjusting knobs rotameter block



Take tubes and cables out of the upper cable holder (6)



Loosen both screws (B) on the upper holding plate



Loosen screw and nut (C) on the lower holding plate 6

B

C Figure 45: Removing rotameter block



You are now able to take the rotameter block carefully out of the device. The holding plates are still attached to the rotameter block and have to be removed assembled. Make sure, not to disconnect any other tubes or cables.



Remove the holding plates on the detached rotameter block and attach them on the new rotameter block.



Attach the new rotameter block with holding plates to the device with screws (B) and (C).



Attach the adjusting knobs on the front side of the rotameter block with threaded pins (A).



9-54

Reconnect all tubes and cable connections (1) – (5).

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

chapter 9: Repairs

Attachment by screws from the front to the front module: The rotameter block is connected to the front module by screws from the front. 

Open the rear panel of the device. 4





5

Loosen the tubes at rotameter block o

AIR (1) (6mm, black)

o

N2O (2) (4mm, blue) (if available)

o

O2 (3) (6mm, grey)

o

fresh gas (4) (Teflon, transparent)

Loosen the cable for backlight of the rotameter block (5)

3 1

2

Figure 46: rotameter block



Loosen the adjusting knobs on the front side of the rotameter block by loosening the threaded pins (A).

B

B

A

Figure 47: adjusting knobs rotameter block



Remove the Plexiglas cover by loosening screws (B).

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9-55

chapter 9: Repairs

C

C



Loosen the rotameter block by loosening screws (C).



The rotameter block can be taken out to the back of the device.



A distance piece (6) between front module and rotameter block is needed.

C 6

Figure 48: Rotameter block without Plexiglas cover



Attach the new rotameter block with screws (B) and (C). Be sure to assemble the rotameter block with distance piece (6).



Attach the adjusting knobs on the front side of the rotameter block with threaded pins (A).



Reconnect tubes (1)-(5).

9.6.3

Testing the rotameter block

After the replacement of the rotameter block it has to be checked on functioning. Therefore, perform the following test items. 

8.7.10 Test of rotameter block

Follow the instruction in Service Manual, chapter 8 Tests!

9-56

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chapter 9: Repairs

9.7

Replacement AC/DC converter

9.7.1

Required materials

Required tools: 

Socket wrench (7mm)



Phillips screw driver

Required material: 

AC/DC converter (Art. Nr.: 0209605)

9.7.2

Disassembling AC/DC converter



Open the rear panel of the device



The AC/DC converter is placed on the hinged rear panel

A A: nuts attachment AC/DC converter B: screws attachment protection plate

1

B A

6 7

5

4

3 2

Cable 1: mains connection board 2: +24V Adapter board 3: GND Adapter board 4: Outlet Power Fail Adapter board 5: +24V Actors-ConnectorBoard (and lightning, if available) 6: GND Actors-ConnectorBoard (and lightning, if available) 7: Inlet ON/OFF ActorsConnector-Board

Figure 49: AC/DC converter

Mark the cables to prevent interchanges. 

Remove the cables to the AC/DC converter (see Figure 49).



Loosen nuts (A), to be able to remove the AC/DC converter out of the device



Loosen screws (B) and remove the protection plate



Screw the protection plate on the new AC/DC converter with screws (B) Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

9-57

chapter 9: Repairs



Screw the AC/DC converter on the rear panel with nuts (A)



Reconnect the cables to AC/DC converter (see Figure 49). Make sure to prevent interchanges



Close the rear panel of the device Switch/transposition of the power lines of the AC/DC converter Device cannot be turned on again

ACHTUNG

9.7.3



Make sure not to switch the power lines

Testing the AC/DC converter

After the replacement of the AC/DC converter it has to be checked on functioning. Perform the following test items: 

Electrical safety test

Follow the instruction in Service Manual in the according testing instruction.

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chapter 9: Repairs

9.8 9.8.1

Rebuilding of the vaporizer holder Required material

Required tools: 

Allen key with ball head (size 4 mm)



Phillips screw driver

Required material: 

Selectatec vaporizer holder (item no: 0209210)

OR 

Dräger vaporizer holder for rebuilding (item no: 0209211bg)

Consisting of: 

Dräger vaporizer holder (item no: 0209211)



2 x distance pieces (item no: 0200493-2)



2 x countersink screw cross slot M5x10 (item no.: 0060352)

9.8.2

Differences vaporizer holder Dräger and Selectatec

There are two different vaporizer holders available. These are intended for Dräger or Selectatec vaporizers. Differences are in the distance between check valves and locking mechanism. In addition, distance pieces are attached in different positions.

Figure 50: Selectatec vaporizer holder left and Dräger vaporizer holder right

Rebuilding of the vaporizer holder is possible. If you change from Selectatec to Dräger vaporizer holder, additional distance pieces have to be attached to the housing leon/leonplus.

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

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chapter 9: Repairs

9.8.3

Replacement vaporizer holder



Open the rear panel of the device



Screws (A) for attachment of the vaporizer holder are located under the generator module.



These could be reached through gaps in the holding plate of the generator module.

1: Inlet vaporizer holder 2: Outlet vaporizer holder A A

A: screw attachment vaporizer holder (semicircular or circular gap in the generator module)

1 2 Figure 51: loosen vaporizer holder

The screw (A) on the left is difficult to open because it is attached close to the housing. Loosen this screw with an Allen key with ball head. 

Loosen both tubes (1) + (2) on the under side of the vaporizer block



Take the vaporizer block carefully out of the device.



Place the new block in the device and attach both tubes (1) + (2) accordingly.



Screw the new vaporizer block on with screws (A)

9-60

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chapter 9: Repairs

9.8.4

Additional work steps change from Selectatec to Dräger vaporizer Rebuilding to Dräger vaporizer holder Leakage vaporizer holder

CAUTION



Mount distance pieces on the housing leon/leonplus

The distance pieces are directly attached to the housing leon/leonplus by vaporizer holder Dräger. During the rebuilding procedure you have to attach these. In difference the distance pieces of the Selectatec vaporizer are attached to the vaporizer block. These are delivered completely mounted.

Additional required tools: 

drilling jig (see addendum of this chapter)



drill machine/cordless electric drill



drill (3 mm)



countersink

Procedure: 

Use the attached drilling jig for finding the position of the drilling holes!



Print the drilling jig with printer setting „Page adjustment: none“ to assure that the drilling jig is printed in the correct size. Printing drilling jig Risk of printing in wrong size

CAUTION



Print drilling jig with page adjustment „none“



Check if the drilling holes on your hard-copy have a diameter of 3 mm

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9-61

chapter 9: Repairs



Cut the drilling jig out at the given lines and put it under the vaporizer on the housing.

Figure 52: Position drilling jig



Drill two holes for the distance pieces from the front of the housing and countersink these



9.8.5

Attach the distance pieces, each by one countersink

Calibration after the replacement of the vaporizer holder

After the replacement of the vaporizer holder it has to be checked whether the pressure conditions are still the same. Therefore perform the following calibration: 

7.6.4 Fresh gas blender inlet pressures

Follow the instruction in Service Manual, chapter 7 calibration procedure

9.8.6

Testing the vaporizer holder

After the replacement of the vaporizer holder it has to be checked on tightness. Therefore, perform the following tests: 

8.7.1 Fresh gas system tightness leonplus



respectively 8.7.2 Fresh gas system tightness leon

Follow the instruction in Service Manual, chapter 8 Testing

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chapter 9: Repairs

9.9

Replacement O-rings of vaporizer holder

9.9.1

Required materials

Required tools: 

Allen key (size: 4 mm)

Required materials: 

O-Ring kit non-return valve (item no: 0209040-1)

consiting of

9.9.2

o

4 x O-ring upper part outside (item no: 0020005-1)

o

4 x O-ring valve housing top(item no: 0020081)

o

4 x O-ring valve housing bottom (item no: 0020173)

o

4 x O-ring valve housing outside (middle) (item no: 0020174)

o

4 x O-ring valve housing inside (item no: 0020207)

Replacement non-return valves



Open the rear panel of the device (see chapter 9.1)



Uncase the 4 non-return valves (A). Therefore firstly unscrew the 4 screws in the underside of the vaporizer holder. The screws are accessible from inside the device and are located behind the generator module.

A Figure 53: dismounted vaporizer block



Take the 4 non-return valves (B) out (Figure 54). B

Figure 54: Vaporizer holder

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9-63

chapter 9: Repairs



Unscrew the upper part out of the valve housing and replace all O-rings of the valve.



Repeat this procedure for all 4 non-return valves

1

5

2

5

4

3

Figure 55: non-return valve

The following components must be replaced: No. Quan. Item no. Description 1 4 0020005-1 O-Ring upper part outside 2 4 0020081 O-Ring valve housing top 3 4 0020173 O-Ring valve housing bottom 4 4 0020174 O-Ring valve housing outside (middle) 5 4 0020207 O-Ring valve housing inside 

9.9.3

Attach the non-return valves to the vaporizer block with screws (A)

Testing of non-return valves

The non-return valves have to be tested after the replacement of the O-rings 

8.7.1 Tightness fresh gas system leonplus, tightness vaporizer



resp. 8.7.2 Tightness fresh gas system leon, tightness vaporizer

Follow the instructions in chapter 8. Testing

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chapter 9: Repairs

9.10

Replacement Mainboard/Adapterboard

C

9

8

5

12

B

7

4

6

13

2

10

1

3 A

11

1: Adapterboard 2: CFB 3: Mainboard (below Adapterboard) 4: Flowboard 5: Flow-Adapterboard 6: AC/DC converter (white Molex connector 6 pin) 7: Akku (white Molex connector 4-pin) 8: fresh gas alarm sensor (black Molex connector 6pin) 9: Controller-Board (20-pin ribbon cable) 10: external lightning on rear panel (white Molex connector 2-pin) 11: Actors-Connector-Board (50-pin ribbon cable) 12: pressure sample tube to pressure sensor on Mainboard) 13: arm CFB

Figure 56: opened rear panel with Adapterboard, CFB and Mainboard

9.10.1

Required materials

Required tools: 

Crosshead screw driver

Required material: 

Mainboard leonplus (item no: 0208710)

OR 

Adapterboard (item no: 0208705)

OR 

CFB (item no: 0208706)

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chapter 9: Repairs

9.10.2

Replacement Adapterboard



Open the rear panel of the device.



Mainboard and Adapterboard are placed on the rear panel. If you open the rear panel, these boards will be on the opened panel (see Figure 56).



The L-shaped Adapterboard (1) with CFB (2) is located above the Mainboard (3)



To replace the Adapterboards disconnect all cables to the board (6 - 10)



Remove the tube to pressure sensor (12) on the Mainboard



Loosen the screws (A) on the Adapterboard



Pull out the Adapterboard carefully. The connectors on the Adapterboard are difficult to loosen. The board may not be screwed up or twisted because the components could be damaged!



Connect the new Adapterboard carefully.



Detach the CFB from the old Adapterboard by tripping the lateral arm



Reconnect it on the new Adapterboard



Necessary tasks after the replacement of the Adapterboard could be seen in sections 9.10.5, 9.10.6 and 9.10.7.

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9.10.3

Replacement Mainboard

It is necessary to replace the Adapterboard to be able to replace the Mainboard. Additional information can be found in section 9.10.2 

To change the Mainboard you have to loosen screws (B) of the attachment Flowboard (4) and screws (C) of the attachment Flow-Adapter-Board (5) additional (see Figure 56)



Pull out both boards carefully



Loosen the distance pieces between the boards



Loosen the ribbon cable (11) to Mainboard



You are now able to change the Mainboard



For reassembling the boards, follow this instruction in reverse order



Reconnect the Adapterboard and attach it with screws (A). The CFB need not to be replaced!



Plug in all cables to the boards (see Figure 56)



Reconnect the pressure sample tube to pressure sensor on Mainboard through the space in Adapterboard



Necessary tasks after the replacement of the Adapterboard could be seen in sections 9.10.5, 9.10.6 and 9.10.7.

9.10.4

Replacement CFB



For replacement CFB trip the arms on both sides of the CFB (13) (see Figure 56)



Take out the CFB carefully



Insert the new CFB accordingly



Necessary tasks after the replacement of the Adapterboard could be seen in sections 9.10.5, 9.10.6 and 9.10.7.

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9.10.5

Software Update after replacement Adapterboard/CFB

After replacing the Adapterboard the following update is necessary: 

Power Pic Update

After replacing the CFB the following update is necessary: 

Software Update

Follow the instruction in Service Manual, chapter 5 update system software

9.10.6

Calibration after replacement Mainboard

After replacing the Adapterboard the following calibration is needed: 

7.7.4 calibration of pressure sensor

Therefore, follow the instruction in Service Manual, chapter 7 system calibration

9.10.7

Testing the Mainboard/Adapterboard

After replacing the Mainboard respectively Adapterboard the following tests are necessary: 

8.16 Testing airway pressure measurement

Follow the instruction in Service Manual, chapter 8 Tests

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9.11

Replacement Protocol interface

9.11.1

Required materials

Required tools: 

Socket wrench (7mm)



Allen key (2.5mm)



Cross-head screw driver

Required material: 

Board Protocol Interface (item no: 0208708)

9.11.2

Replacement Protocol Interface



Open the rear panel of the device



The protocol interface is located on the inside of the rear panel. It contains the network and COM-interface. 1

B

3

2

A

4

A B

A: Allen screw with counter nut Attachment holding plate B: cross slot screw Attachment board

1: Protocol interface board 2: Holding plate 3: Ethernet network cable 4: Ribbon cable to Controller Board

Figure 57: Protocol interface



Loosen the cables (3) + (4) to Protocol interface (1)



Loosen the counter nuts (A) on the rear side of the board



Take the holding plate (2) out



Loosen screws (B) and take the protocol interface (1) out



Screw the new board with screws (B) on the holding plate (2)



Screw the holding plate with screws (A) on the rear panel



Reconnect cables (3) + (4) Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

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9.12

Replacement mains connection board

9.12.1

Required materials

Required tools: 

Cross-head screw driver



Jaw wrench (5.5 mm; 8mm)

Required material: 

mains connection board (item no: 0208935)

9.12.2

Replacement mains connection board



Open the rear panel of the device



The mains connection board is on the rear panel of the device A

3

5

6

1

7

4

A 2

B

B

B

A: nuts (attachment plate) B: nuts (attachment inlet connector for non-heating apparatus)

B

B

7

6

1: plate 2: mains connection board 3: cable grounding 4: cable AC/DC converter 5: cable Actors-Connector Board 6: connection high pressure sensor O2 7: connection high pressure sensor N2O

Figure 58: mains connection board



Loosen cables (3) - (5)



Loosen nuts (A), to be able to remove plate (1)



Screw the connections for high pressure sensors (6) + (7) out of their socket



Every inlet connector for non-heating apparatus is attached with two nuts (B) on the rear panel

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

Remove the mains connection board (2) carefully



Assemble the board in reverse order



Make sure that the connections for high pressure sensors (6) + (7) are securely attached.

9.12.3

Testing after replacement mains connection board

After the replacement of the mains connection board the fuses have to be checked. 

measure all fuses of the mains connection board

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9.13

Leakage patient module

If leakages of the patient module occur, the patient module has to be opened. This is equivalent to the 6-year maintenance of the patient module. To open the patient module refer to chapter 6 maintenance, 6.5.2 6-year maintenance patient module. All internal O-rings, flat seals have to be replaced, if the patient module was opened.

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9.14

Replacement/Rebuilding bronchial aspiration

There are two different types of bronchial aspiration available. But replacement procedure does not differ in main parts.

Aspiration AIR (injector)

Aspiration VAC (vacuum regulating valve)

Figure 59: Aspiration AIR and VAC

9.14.1

Required materials

Required tools: 

Allen key (size 2.5 mm)



Torx screw driver (TX 20)



Phillips screw driver small



Jaw wrench (size 15 mm; 17 mm)



Adhesive (only needed for rebuilding VAC aspiration)

Required materials: Replacement injector: 

Injector leon/leonplus (item no: 0209575)

Replacement vacuum regulating valve: 

Vacuum regulating valve (item no: 0209576)

Rebuilding VAC to AIR aspiration (injector) 

Aspiration AIR leon/leonplus (item no: 0209570)

Rebuilding AIR to VAC aspiration (Vacuum regulating valve) 

Aspiration VAC leon/leonplus (item no: 0209570-1) Note different tubing system depending on aspiration type. In the appendix you may find a schematic of the tubing system gas box in different versions.

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9.14.2

Aspiration AIR with injector

Figure 60: Gas box with aspiration AIR (Injector)

Aspiration AIR uses an injector to create a vacuum and is driven by drive gas. If you activate aspiration by a change-over valve suction is created that is used for aspiration. Exhaust air is transferred to the rear panel of the gas box and blown off.

9.14.3

Aspiration VAC with vacuum regulating valve

Figure 61: Gas box with aspiration VAC (Vacuum regulating valve)

Aspiration VAC uses a vacuum wall connection to create bronchial aspiration. The vacuum is transferred by a NIST connection on the rear panel of the gas box to the aspiration. A change-over valve activates and a vacuum regulating valves regulates the vacuum.

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9.14.4 

Replacement injector/vacuum regulating valve Take the gas box out of the device. Therefore follow the instruction in chapter 9.2.2 Removing the gas box and chapter 9.2.3 Disconnecting tube and cable connections.



Loosen the tubes to injector resp. vacuum regulating valve.



The injector resp. vacuum regulating valve is connected by two cross tips screws (A) on the front side of the gas box.

A

Figure 62: Replace injector/Vacuum regulating valve



Replace the defective component.



Connect tubes to the injector according to Figure 63 left side.



Connect tubes to the vacuum regulating valve according to Figure 63 right side.

3

3

2 5

1

4

1

2

Injector:

Vacuum regulating valve:

1: Drive gas supply from T-piece to VAC switch 2: VAC switch to injector 3: T piece injector to manometer 4: Exhaust air aspiration 5: Connection aspiration to device

1: Tube from NIST connection to VAC switch 2: VAC switch to regulating valve 3: T piece regulating valve to manometer 4: Tube aspiration to device

4

Figure 63: Left: Connection tubes injector, Right: Connection tubes vacuum regulating valve

Note different tubing system depending on aspiration type. In the appendix you may find a schematic of the tubing system gas box in different versions.

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

Reconnect the gas box to the device.



Make sure that all tubes are connected correctly. Therefore follow the instruction in chapter 9.2.2 Removing the gas box and 9.2.3 Disconnecting tube and cable connections.



After the replacement of the component tests according to chapter 9.14.7 Testing the gas box should be performed.

9.14.5

Rebuilding aspiration VAC to AIR

If you replace the aspiration VAC by an aspiration AIR (injector) the following steps have to be performed: 

Take the gas box out of the device. Therefore follow the instructions in chapter 9.2.2 Removing the gas box and chapter 9.2.3 Disconnecting tube and cable connections.



Loosen the tubes to the vacuum regulating valve.



Loosen the vacuum regulating valve by loosening the two cross tip screws (see Figure 62, page 9-75)

5

6

3

1: Injector 2: tube fitting 3: straight tube fitting 4: elbow union 5: tube PU white 6: straight tube fitting

2

4

1 Figure 64: Parts injector



Assemble the injector according to Figure 64



Connect the injector with two cross tip screws on the gas box



Attach the exhaust air port on the rear panel of the gas box (see Figure 65, page 977).



Remove the vacuum NIST-connection on the rear side of the gas box. This connection is difficult to loosen because it is glued to the rear panel.

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

A second T piece is needed on connector block outlet TG (see Figure 65). Connect the tubes according to Figure 65. 4

5

3

1: Connector block 2: Tube to VAC switch 3: Tube to drive gas generator 4: Tube to pressure measurement drive gas generator board 5: Exhaust air port (rear panel gas box)

2

1

Figure 65: Connection aspiration AIR to connector block and exhaust air port



Connect the tubes according to Figure 66

Injector: 1: Drive gas supply from T-piece to VAC switch 2: VAC switch to injector 3: T piece injector to manometer 4: Exhaust air aspiration 5: Connection aspiration to device

3

2

1

4

5

Figure 66: tube system injector



Reconnect the gas box to the device.



Make sure that all tubes are connected correctly. Therefore follow the instruction in chapter 9.2.2 Removing the gas box and 9.2.3 Disconnecting tube and cable connections.



After the replacement of the components tests according to chapter 9.14.7 Testing the gas box should be performed.

In the appendix you may find a schematic of the tubing system gas box in different versions.

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9.14.6

Rebuilding aspiration AIR to VAC

If you replace the aspiration AIR by an aspiration VAC (vacuum wall connection) the following steps have to be performed: 

Take the gas box out of the device. Therefore follow the instructions in chapter 9.2.2 Removing the gas box and chapter 9.2.3 Disconnecting tube and cable connections.



Loosen the tubes to the injector.



Loosen the injector by loosening the two cross tip screws (see Figure 62, page 9-75)

5

4

1: Vacuum regulating valve 2: T piece tube fitting 3: straight tube fitting 4: straight tube fitting 5: NIST connection VAC 3

1 2 Figure 67: Parts vacuum regulating valve



Assemble the vacuum regulating valve according to Figure 67



Connect the vacuum regulating valve with two cross tip screws on the gas box



The second T piece on the connector block outlet TG is no longer needed (see Figure 68). Remove one T piece and the tube to VAC switch (2)



Adhere the NIST connection (5) with the tube fitting (6) to the rear panel of the gas box (Figure 68). 4 3 5 2

1

1: Connector block 2: Tube to VAC switch 3: Tube to drive gas generator 4: Tube to pressure measurement drive gas generator board 5: NIST connection 6: Tube fitting Figure 68: Connector block and NIST-connection

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

Connect the tubes according to Figure 69

3

Vacuum regulating valve: 1: Tube from NIST connection to VAC switch 2: VAC switch to regulating valve 3: T piece regulating valve to manometer 4: Tube aspiration to device

1

2

4 Figure 69: Tube system vacuum regulating valve



Reconnect the gas box to the device.



Make sure that all tubes are connected correctly. Therefore follow the instruction in chapter 9.2.2 Removing the gas box and 9.2.3 Disconnecting tube and cable connections.



After the replacement of the components tests chapter 9.14.7 Testing the gas box should be performed.

In the appendix you may find a schematic of the tubing system gas box in different versions.

9.14.7

Testing the gas box

After assembling the gas box the following test items have to be performed: 

8.7.1 fresh gas system tightness leonplus respectively 8.7.2 fresh gas system tightness leon



8.14.5 Vacuum injector and vacuum meter test



8.20 Function test of nitrous oxide gas lock (only leonplus)

Therefore, follow the instructions in Service Manual, chapter 8 Tests.

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9.15

Rebuilding option panel

The option panel is either equipped with an external fresh gas outlet or an external O2 outlet. Rebuilding of the other configuration is in each case possible.

External fresh gas outlet with change-over valve

External O2 outlet with flowmeter

Figure 70: Configuration option panel

9.15.1

Required material

Required tools: 

Torx screw driver (TX20)



Cable cutter

Required material: Rebuilding to O2 flowmeter leonplus:  Option panel leonplus (item no: 0209004-1), Note option water trap receptacle (Oxima) 

Link plug ACB connection X10 (item no: 0170480)



PU Tube grey, length: 130 cm (connector block to flowmeter) (item no: 0011047)



PU Tube grey, length: 25 cm (flowmeter to ext. O2 outlet) (item no: 0011047)



Tube Teflon, length: 135 cm (non-return valve to gas supply) (item no: 0011007)

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Rebuilding to O2 flowmeter leon:  Option panel leon (item no: 0209004-3), Note option water trap receptacle (Oxima) 

Link plug ACB X10, connection X10 (item no: 0170480)



T-piece (item no: 0070021-1)



PU Tube, grey, length: 13 cm (rotameter block to flowmeter) (item no: 0011047)



Pu Tube grey, length: 25cm (outlet flowmeter to ext. O2-outlet) (item no: 001047)



Tube Teflon, length: 135 cm (non-return valve to gas supply) (item no: 0011007)

Rebuilding to fresh gas change-over leonplus:  Option panel leonplus (item no: 0209004), Note option water trap receptacle (Oxima) 

Closing plug (item no: 0070075) (for outlet O2 OPT connector block) (leonplus)



Tube Teflon, length: 28 cm, (fresh gas change-over to gas supply), (item no: 0011007)



Tube Teflon, length: 25 cm (fresh gas change-over to ext. FG outlet), (item no: 0011007)

Rebuilding to fresh gas change-over leon:  Option panel leon (item no: 0209004-2), Note option water trap receptacle (Oxima) 

Closing plug (item no: 0070075), (for outlet T-piece) (leon)



Tube Teflon, length: 28 cm, (fresh gas change-over to gas supply) (item no: 0011007)



Tube Teflon, length: 25 cm, (fresh gas change-over to ext. FG outlet) (item no: 0011007)

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9.15.2

Rebuilding option panel to O2 outlet

If you want to convert the option panel to O2 outlet perform the following steps: 

Open the rear panel of the device.

Procedure leonplus: 2

1

Access to gas box

Figure 71: Rebuilding option panel leonplus



You are now able to reach the gas box. Remove the closing plug of the outlet O2 OPT of the connector block. The outlet O2 OPT (1) is located in front of the pressure reducer (2).



If you have removed the closing plug connect the delivered tube (grey, length 130 cm) there.



Place the cable into the cable holders to the option panel.

Procedure leon:

1 2

Figure 72: Rebuilding option panel leon



Cut the tube (1) to the rotameter block near the option panel in two.



Insert the T-piece (2) there.

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Further procedure leon and leonplus: 

Remove the tubes and cable to emergency dosing (leonplus). Mark tubes to be able to reconnect them afterwards.



Remove the tubes and cable from water trap to gas measurement bench (leon/leonplus). Mark tubes and cables to be able to reconnect them afterwards.



Remove the cable and tubes to the fresh gas outlet.



Remove the option panel by loosening the four screws (A).

A

A

Figure 73: Removing the option panel



Attach the new option panel with four screws (A).



Reconnect cable (5) and tubes (1) – (4) to emergency dosing and from water trap to gas measurement bench. 1

2 3 5

4

1: Tube from switch block (only leonplus) 2: Tube to generator module (only leonplus) 3: Tube to AION, fourth inlet 4: Tube to AION, first inlet 5: Cable to AION gas measurement bench 6: Tube from connector block O2 OPT resp. rotameter block 7: Tube to outlet port O2 outlet There are two additional tubes connected if you use an oxygen measurement by Oxima fuel cell (see 9.4.4.3 Version 2: water trap receptacle with Oxima fuel cell)

6

7

Figure 74: Tubing/Cabling option panel with O2 outlet



Connect the tube from connector block resp. from T-piece of rotameter block (6) to the inlet of the O2 flow meter.

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

The lower connection (7) of the flow meter has to be connected to the outlet port of the option panel (PU tube grey, length 25 cm).

B 8

9 Figure 75: Gas supply and non-return valve



Remove the cover below the rear panel by loosening the screws (B).



Disconnect the fresh gas tube (8) of the right plug gas supply. Remove this tube totally.



Disconnect the fresh gas tube from outlet non-return valve, right connection of the Tpiece (9). Remove this tube totally.



Connect the outlet of the T-piece (9) to the plug gas supply (8) by the supplied fresh gas tube (Tube Teflon, length 135 cm). Place the tube into the cable holders.

10 11

Connector block with Actors-Connector-Board

Figure 76: Connection link plug on Actors-Connector-Board



Plug in the link plug (10) on the connection X10 (11) on the Actors-Connector-Board.



After the replacement of the components perform the tests according to chapter 9.15.4 Testing the option panel.

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chapter 9: Repairs

9.15.3

Rebuilding option panel to fresh gas outlet

If you want to convert the option panel to fresh gas outlet perform the following steps: 

Open the rear panel of the device.

Procedure leonplus: 2

1

Access to gas box

Figure 77: Rebuilding option panel leonplus



You are now able to reach the gas box. Remove the tube of the outlet O2 OPT of the connector block. The outlet O2 OPT (1) is located in front of the pressure reducer (2).



Block the outlet O2 OPT by the delivered closing plug.

Procedure leon:

2

1

Figure 78: Rebuilding option panel leon



Disconnect the tube from external O2 outlet (1) to T-piece (2). Block the outlet by the delivered closing plug.

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chapter 9: Repairs

Further procedure leon and leonplus: 

Remove the tubes to the emergency dosing (leonplus). Mark tubes to be able to reconnect them later.



Remove the tubes and cable from the water trap to the gas measurement bench (leon/leonplus). Mark tubes and cables to be able to reconnect them later.



Remove the tube to the O2 outlet.



Remove the option panel by loosening screws (A)

A

A

Figure 79: Removing option panel



Attach the new option panel with screws (A) accordingly.



Reconnect the cable (5) and tubes (1) – (4) to emergency dosing and from water trap to gas measurement bench. 1 2

3 4 5

1: Tube from switch block (only leonplus) 2: Tube to generator module (only leonplus) 3: Tube to AION, fourth inlet 4: Tube to AION, first inlet 5: Cable to AION gas measurement bench 6: Tube from outlet non-return valve 7: Tube to outlet port FG outlet 8: Tube to gas supply 9: Cable to Actors-Connector-Board

6

8

7

There are two additional tubes connected if you use an oxygen measurement by Oxima fuel cell (see 9.4.4.3 Version 2: water trap receptacle with Oxima fuel cell)

9

Figure 80: Tubing/Cabling option panel with fresh gas outlet

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B 10

Figure 81: Gas supply



Remove the cover below the rear panel by loosening the screws (B).



Disconnect the fresh gas tube (10) of the right plug gas supply.



Shorten this tube to be able to connect it to connection (6) Figure 80



Connect the connection (8) to the gas supply (10) by the delivered fresh gas tube (Tube Teflon, length 28 cm).



The connection (7) of the fresh gas change-over has to be connected to the outlet plug of the option panel (Tube Teflon, length: 25 cm).

11 12

Connector block with Actors-Connector-Board Figure 82: Link plug on Actors-Connector-Board



Remove the link plug (11) on the Actors-Connector-Board on connection X10 (12).



Plug in the cable (9) of the fresh gas change-over on connection X10 (12)



After the replacement of the components perform tests according to chapter 9.15.4 Testing the option panel

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9.15.4

Testing the option panel

The following tests are necessary after the rebuilding of the option panel: 

8.7.1 Fresh gas system tightness leonplus



resp. 8.7.2 Fresh gas system tightness leon



8.7.11 Testing option panel



8.14.1 Testing the O2 emergency dosing (only leonplus)



8.14.3 Testing O2 auxiliary flow meter (optional)



8.15.1 Ext. fresh gas control switch (if applicable)

Therefore follow the instruction in Service Manual, chapter 8.Testing.

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9.16

Internal connection workstation illumination

The internal connection of the workstation illumination can be attached afterwards if the optional workstation illumination is requested.

9.16.1

Required material

Required material: 

internal connection workstation illumination (item no: 0209458)

Required tools: 

Jaw wrench (size 14 mm, 17 mm)



cross slot screw driver

9.16.2 

Installation of the internal connection workstation illumination Open the rear panel of the device.

1 4

4 2 2 3 1

5

Figure 83: Installation female connector workstation illumination

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

Mount the fuse carrier (1) on the corresponding place of the rear panel. Attach the fuse carrier with a jaw wrench.



Mount the female connector of the workstation illumination (2). Tighten the connector with a jaw wrench. Make sure that the mark of the connector (3) is located to the bottom.



Connect the cable of the female connector (4) to the fuse carrier. It does not matter which cable you connect to which port of the fuse carrier.



Connect the cable to the adapter board (5).



Connect the cable to the AC/DC converter. Make sure to connect the red line to the red connection (6), the black line to the black connection (7).

7

6

Figure 84: Connection supply line workstation illumination



Close the rear panel of the device.



The cable clip is used for connection of the external cable of the illumination. Attach the cable clip on the upper left screw of the rear panel.



Mount the workstation illumination. Follow the instruction in chapter 9.17 Assembling workstation illumination.

9.16.3

Testing the connection of the workstation illumination

Test the connection of the workstation illumination in the following way: 

Test the female connector by inserting the lamp and checking the function.



Perform a leakage current test.

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9.17 9.17.1

Assembling workstation illumination Required material

Required material: 

workstation illumination leon/leonplus incl. assembling accessory (item no: 0209455)

Required tools: 

Cross slot screw driver



Slotted screw driver

9.17.2

Assembling the workstation illumination

The optional workstation illumination is mounted on the lateral rail system.

Figure 85: Assembling the optional workstation illumination



Therefore remove the cover (1) of the rail system (2). Press it upwards out.

1

2

3

Figure 86: Lateral rail system



Remove the cover profile (3) of the profile flute up to the mounting position of the workstation illumination. Cut the cover profile to the correct length.

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9-91

chapter 9: Repairs



Mount spring nuts (6) with screws (5) on mounting (3). The screws may not be tightened. Otherwise a further assembling is not possible.



Insert the pre-mounted mounting (7) into the second profile flute (8). The spring nuts have to be pressed to be able to insert them into the flute.



Make sure the opening (4) of the mounting is towards the rear of the device.

5

6

4

7

3

6 8

5 Figure 87: Assembling mounting workstation illumination



Place the mounting in position and fix the mounting by tightening both countersunk screws.



Insert the cover profile (3) above the mounting in the profile flute.



Tighten workstation illumination (9) with screw (10) on mounting.

9

10 9 11

Figure 88: Assembling workstation illumination



9-92

Lay the cable of the illumination through the cable inlet (11) of the swing door.

Heinen + Löwenstein, leonplus/leon Rev. 2.3.3

chapter 9: Repairs



Attach cable clip (12) on the left upper screw of the rear panel. Lay the cable through this cable clip.



Plug the illumination plug into the according socket (13) on the rear panel.

12

13

Figure 89: Connection workstation illumination on socket rear panel

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9-93

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Appendix Gas box leon with aspiration AIR

9-94

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chapter 9: Repairs

Gas box leonplus with aspiration AIR

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9-95

chapter 9: Repairs

Gas box leon with aspiration VAC

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chapter 9: Repairs

Gas box leonplus with aspiration VAC

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9-97

chapter 10: Configuration

10 Configuration Contents Seite 10.1 10.2 10.2.1 10.2.2 10.2.3 10.2.4

Configuration of the device ..........................................................................10-3 Gas measurement........................................................................................10-4 External gas measurement......................................................................10-4 Internal O2 Measurement ........................................................................10-5 Combination of gas and O2 measurement ...............................................10-5 CO2 unit ...................................................................................................10-6

10.3 10.4 10.5 10.5.1 10.5.2 10.5.3 10.5.4 10.5.5

ppeak Alarm....................................................................................................10-6 Man/Spont....................................................................................................10-7 Gas supply ...................................................................................................10-8 Prob gas ..................................................................................................10-8 N2O supply ..............................................................................................10-8 O2 supply .................................................................................................10-9 Air supply.................................................................................................10-9 Dependencies gas supply .....................................................................10-10

10.6 10.7 10.8 10.9 10.10 10.11

Freshgas alarm ..........................................................................................10-11 Screensaver ...............................................................................................10-11 Ambient settings.........................................................................................10-12 Vue Link .....................................................................................................10-13 serial Protocol ............................................................................................10-14 Configuration of the User Interface ............................................................10-15

Figures Seite Figure 1: Configuration-Menu (page 1) .............................................................................10-3 Figure 2: Configuration-Menu (page 2) .............................................................................10-3 Figure 3: Configuration of the gas measurement..............................................................10-4 Figure 4: menu item external gas measurement ..............................................................10-4 Figure 5: menu item internal O2 Measurement .................................................................10-5 Figure 6: menu item CO2 unit............................................................................................10-6 Figure 7: menu item ppeak Alarm........................................................................................10-6 Figure 8: Regulation of ppeak by increasing of pinsp ............................................................10-6 Figure 9:menu item Apnea time in ventilation mode Man/Spont.......................................10-7 Figure 10: Configuration gas supply .................................................................................10-8 Figure 11: menu item prob gas .........................................................................................10-8 Figure 12: menu item N2O supply .....................................................................................10-8 Figure 13: menu item O2 supply........................................................................................10-9 Figure 14: menu item Air supply .......................................................................................10-9 Figure 15: configuration Fresh gas alarm .......................................................................10-11 Figure 16: menu item freshgas alarm .............................................................................10-11 Figure 17: configuration screensaver..............................................................................10-11 Figure 18: menu item screensaver .................................................................................10-11 Figure 19: configuration ambient settings with AION ......................................................10-12 Figure 20: configuration ambient settings without AION .................................................10-12 Figure 21: configuration VueLink ....................................................................................10-13 Figure 22: menu item VueLink ........................................................................................10-13 Figure 23: configuration serial protocol...........................................................................10-14 Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.2

10-1

chapter 10: Configuration

Figure 24: menu item serial protocol...............................................................................10-14

Tables Seite Table 1: Extent of measurement .......................................................................................10-4 Table 2: possible combinations gas measurement – oxygen measurement ....................10-5 Table 3: combinations gas supply...................................................................................10-10

10-2

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chapter 10: Configuration

10.1

Configuration of the device

leon/leonplus is available in different configurations. Necessary settings can be done in Service. Configuration Service does not correspond to the device Malfunction of the device CAUTION



The chosen configuration has to be equivalent to the real situation in the device!

Navigate to the menu item „Service ► Configuration ► Configuration“ (1. page)

Figure 1: Configuration-Menu (page 1)

Figure 2: Configuration-Menu (page 2)

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10-3

chapter 10: Configuration

10.2

Gas measurement

Gas measurement includes measurement of the O2-concentration as well as CO2 and Agent gas concentration. It is available in different configurations. Changes in settings are only active after a reboot of the system!

Figure 3: Configuration of the gas measurement

10.2.1

External gas measurement

External gas measurement includes Agent gas and CO2 measurement by Artema AION. Oxygen measurement is done separate, not by AION. It can be chosen between the following configurations: menu item:

Figure 4: menu item external gas measurement

The setting “none“ has to be chosen if no AION is used in the device. The User Interface changes after a reboot according to the selected settings. An O2 measurement is still possible (see section 10.2.3). The setting “Artema AION“ includes all available versions (AION 01, AION 02 and AION 03). It is automatically detected which version is used in the device and no further settings are needed. The extent of measurement varies between the different versions (see Table 1). gas measurement CO2 measurement N2O measurement Agent gas Auto ID AION 01 yes yes AION 02 yes yes yes AION 03 yes yes yes yes Table 1: Extent of measurement

The values are displayed as percentage in the window of the gas measurement. The User Interface fits to the settings after a reboot of the system. Oxygen measurement has to be done separate. For the possible combinations of gas measurement and oxygen measurement see section 10.2.3. 10-4

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.2

chapter 10: Configuration

10.2.2

Internal O2 Measurement

The internal O2 Measurement includes the measurement of the FiO2 concentration by a fuel cell (KE 25). The following settings are possible: menu item:

Figure 5: menu item internal O2 Measurement

If you have a KE25, the setting has to be „enabled“. The fuel cell also has to be placed on the inspiratory port on the patient module and has to be connected electrically. This kind of oxygen measurement only detects the inspiratory oxygen content; the expiratory oxygen content is not detected. The User Interface fits to the settings after a reboot of the system and in the window of the gas measurement the inspiratory oxygen measurement (FiO2) is displayed. If you use Servomex or Oxima O2 measurement, the internal O2 measurement has to be set to “disabled”. The window of the gas measurement displays the concentration measured by Servomex or Oxima. If no oxygen measurement is used, the setting has to be “disabled”, too. In the window of the gas measurement is no O2 value displayed. An independent monitoring unit is necessary.

10.2.3

Combination of gas and O2 measurement

All combinations of gas measurement and O2 measurement are possible. But not all are distributed as standard configuration. Table 2 shows the configuration in Service according to configuration in the device. Device gas measurement Artema AION 01/02/03 Artema AION 01/02/03 Artema AION 01/02/03 Artema AION 01/02/03 -

O2 measurement

Configuration Service external gas internal O2 measurement measurement

Oxima

Artema AION

inactive

Servomex

Artema AION

inactive

KE25

Artema AION

active

-

Artema AION

inactive

KE25 -

none none

active inactive

Table 2: possible combinations gas measurement – oxygen measurement

The adjusted configuration has to correspond to the configuration actually existing in the device. Otherwise error messages will appear and concentrations will not be displayed correctly.

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10-5

chapter 10: Configuration

10.2.4

CO2 unit

It is possible to choose the CO2 unit. The following units are available: menu item:

Figure 6: menu item CO2 unit

The settings are only active after a reboot of the system.

10.3

ppeak Alarm

The setting ppeak Alarm regulates the default difference between pmax respectively pinsp and the alarm threshold ppeakAlarm. When the pressure ppeakAlarm is reached, the breathing will be cancelled and the expiration will be initiated by opening the plateau valve.

Figure 7: menu item ppeak Alarm

Menu item: Default Difference to insp. pressure [mbar]

5 .. 30

Recommended setting:

10 mbar

The threshold ppeak Alarm is always at the favoured difference higher than the pressure pmax respectively pinsp. Only at the maximum pressure of 80 mbar the favoured difference will not be kept and the threshold ppeakAlarm will be set to 85 mbar.

Increasing pinsp of 5 cmH2O

=>

Automatic regulation of ppeak Alarm

Figure 8: Regulation of ppeak by increasing of pinsp

The setting of the threshold ppeak Alarm is also possible in threshold window. But a change there is not passed to other ventilation modes. Only the active one uses the new threshold. If you switch to any other ventilation mode, the default difference is used again. 10-6

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chapter 10: Configuration

10.4

Man/Spont.

The setting Apnea time describes the time to detect a manual or spontaneous breathing in ventilation mode man/spont. Otherwise an Apnea alarm is activated.

Figure 9:menu item Apnea time in ventilation mode Man/Spont

menu item: Apnea time:

[s]

Recommended setting:

10 .. 60 30 s

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10-7

chapter 10: Configuration

10.5

Gas supply

The configuration of the gas supply has to be set according to the situation at the place of installation.

Figure 10: Configuration gas supply

10.5.1

Prob gas

Menu item:

Figure 11: menu item prob gas

Air and O2 are available as prob gas. If one of these gases fails, prob gas is changed to the other one automatically. An alarming appears in the alarm window.

10.5.2

N2O supply

Menu item:

Figure 12: menu item N2O supply

The selection N2O supply includes the possibilities „Pipeline“, „Tank“ and „not available“. The operation with „Tank“ means the operation with 10l tanks, not additional reserve gas bottles. Some dependencies have to be noticed (see section 0).

10-8

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chapter 10: Configuration

10.5.3

O2 supply

Menu item:

Figure 13: menu item O2 supply

The selection O2 supply includes only the possibilities „Pipeline“ and „Tank“. The option “not available” is not applied because a device without O2 supply is not permitted. “Tank” means the operation with 10l tanks, not additional reserve gas bottles. Some dependencies have to be noticed (see section 0).

10.5.4

Air supply

Menu item:

Figure 14: menu item Air supply

The selection Air supply includes the possibilities „Pipeline“, „Tank“ and „not available“. The operation with „Tank“ means the operation with 10l tanks, not additional reserve gas bottles. Some dependencies have to be noticed (see section 0).

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10-9

chapter 10: Configuration

10.5.5

Dependencies gas supply

Not all combinations of gas supply are possible. It is not possible to set up a N2O tank and an Air tank. A configuration without O2 is not allowed. But it is possible to set up a device with only O2 and choose N2O and Air “not available”. Prob gas is set up accordingly. If Air is available, it can be chosen as prob gas. Otherwise O2 is set up as prob gas. The following combinations of gas supply are possible: O2 Pipeline Tank Pipeline Tank Pipeline Tank Pipeline Tank Pipeline Tank Pipeline Tank Pipeline Tank Pipeline Tank

N2O not available not available Pipeline Pipeline Tank Tank not available not available Pipeline Pipeline Tank Tank not available not available Pipeline Pipeline

AIR not available not available not available not available not available not available Pipeline Pipeline Pipeline Pipeline Pipeline Pipeline Tank Tank Tank Tank

prob gas O2 O2 O2 O2 O2 O2 AIR or O2 AIR or O2 AIR or O2 AIR or O2 AIR or O2 AIR or O2 AIR or O2 AIR or O2 AIR or O2 AIR or O2

Table 3: combinations gas supply

There is no difference between configuration and real situation of gas supply allowed. It is detected in system test if the configuration is correctly chosen. During ventilation error messages show false configuration that have to be corrected immediately.

10-10

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chapter 10: Configuration

10.6

Freshgas alarm

The freshgas alarm manages the optional available bellow sensor. It controls the freshgas supply of the system. If the system receives less fresh gas and the reservoir gets empty, an error message appears to show this deficit. The additional sensor has to be activated in configuration menu:

Figure 15: configuration Fresh gas alarm

Menu item:

Figure 16: menu item freshgas alarm

10.7

Screensaver

The configuration of the screensaver is located on the second page of the service menu:

Figure 17: configuration screensaver

Menu item:

timeout

[min]

1 .. 60

Figure 18: menu item screensaver

The screensaver is displayed if the device is longer than the adjusted time in standby operation. By touching the touch screen the screensaver disappears. It can be chosen between different versions of screensaver.

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10-11

chapter 10: Configuration

10.8

Ambient settings

Ambient settings include ambient temperature and ambient pressure. The display varies depending on gas measurement (AION).

Figure 19: configuration ambient settings with AION

Figure 20: configuration ambient settings without AION

Menu item temperature: Ambient temperature Recommended setting

°C

10 .. 35 25°C

Ambient temperature could be adjusted. This setting is only needed if no AION is integrated in the device. Otherwise the AION will send this value. But it does not matter if the temperature is adjusted additional. By operation without AION the adjustment of this setting is necessary. Menu item pressure: If the device is equipped with AION, the ambient pressure is measured by the AION and displayed in the window ambient settings (see Figure 19). If the device is not equipped with an AION, the altitude should be adjusted (see Figure 20). Altitude

meter

0 .. 4000

The barometric pressure is then calculated by the altitude and displayed in the window ambient pressure.

10-12

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chapter 10: Configuration

10.9

Vue Link

VueLink is a communication interface for sending values to an external Philips monitor. Therefore the RS232 interface COM1 on the back of the device is used (if available). RS232 interface COM 1 is optional on leon.

Figure 21: configuration VueLink

Menu item:

Figure 22: menu item VueLink

The connection has to be enabled if the device is equipped with an additional Philips monitor.

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10-13

chapter 10: Configuration

10.10 serial Protocol Changes are only active after a reboot of the system. The serial protocol is another communication interface for sending data via a specified protocol. Therefore the RS232 interface COM2 on the back of the device is used (if available). RS232 interface COM 2 is optional on leon.

Figure 23: configuration serial protocol

menu item:

Figure 24: menu item serial protocol

The serial protocol is send via COM2 during “enabled“ mode. Thereby it could be chosen between two operation modes. “Event driven” means that at every event values are send. An event could be for example a breath or a change in settings. Operation mode “request driven” means that only data are send if the connected unit asks for it. Software Version 3.0.0 leonplus If you choose mode “event driven” you have to choose the Protocol Version.

10-14

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.2

chapter 10: Configuration

10.11 Configuration of the User Interface The user interface can be varied by adjustable default values. Therefore follow the instruction in user manual, chapter 11 Configuration. Notice: The following notices should be noted:     

PCV / S-PCV: setting pmax appr. 20 cmH2O (factory setting 40 cmH2O) Frequency in synchronised modes: children and adult >10 1/min setting CO2 curve visible Alarm minimum threshold O2 = 30% IMV / S-IMV set always with plateau > 10%

More detailed information is not given at this place. The settings must be adjusted with the responsible operators on side. The device may not be operated with factory settings because life threatening situation could happen. The settings should be adjusted by the responsible operator on side.

Heinen + Löwenstein, Service Manual leonplus/leon Rev. 2.1.2

10-15

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Chap. 5.4.2.1: Instruction added by procedure operating system Windows Vista and Windows 7

1558

Chap. 5.4: Update instruction completed by Update with static IP address

1561

Chap. 5.9: Instruction completed by replacement Monitor PIC and Conductor PIC

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1601

Maintenance separated in maintenance device and maintenance patient module; there will be two separate test instructions.

1577

Chap. 6.2. Annual maintenance: Maintenance kit for leon (item no 0209051-1)

1427

O-Rings high pressure connections have to be exchanged during annual maintenance (Chap. 6.2.3.5)

1553

Service kit Swing arm (0209055), content actualized

06 Maintenance Version 2.2.2

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Chap. 6.5.2.14: Excess diaphragm: Mounting position clearly shown

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Chap. 7.6.9 Hardware calibration flow measurement fresh gas: DRM 4 calibration without FG outlet not described, Solution: Flow measurement setup

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Chap. 7.7.2 Calibration FiO2 and chap. 7.7.3 calibration fresh gas O2 cell added by photo

1617

Procedure of complete calibration of AION and Servomex (correct order of calibration) is missing, added in Chap 7.8

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Chap. 8.10: Calibration FiO2 an fresh gas O2 cell added by photo

1620

Chap. 8.17: Added testing gas measurement (correct order of calibration)

1531

Chap. 8.18.3: Testing O2 fuel cell not possible as described, new test setup inserted

1522

Setting gas standard PF300 wrong or not mentioned Chap 8.7.8, 8.7.9, 8.7.10, 8.9, 8.14.1, 8.14.2, 8.14.3, 8.20: Gas standard 0/1013 Chap 8.23.1, 8.23.2, 8.23.3:Gas standard ATP

1600

Maintenance separated in maintenance device and maintenance patient module; order of test items has been modified

1556

Minimal Flow Test patient module inserted (chap. 8.22.13)

Version

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1619

Chap. 9.4.5 / 9.4.6: Calibration/Setting gas measurement: The correct order has to be maintained

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07_Calibration Version 2.2.3

08_Tests

09 Repairs

10_Configuration Version 2.1.2

No change

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Chap. 6.2.3.2: Water trap receptacle can be located on option plate (leon)

1344

Chap: 6.3.2: If the device is without drawers, the extended rear panel has to be removed to change the batteries.

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Chap: 7.5: Test setup pressure measurement was supplemented by adding option without ext. FG/O2-outlet

1346

Chap. 7.8.2.1 and Chap. 7.8.2.2: AION 01 (N2O and CO2 measurement) added

07_Calibration Version 2.2.2

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Chap. 9.4.1: Addition replacement AION 01

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Chap. 9.4.1.1: Service kits AION (0209094, 0209095) and chap. 9.4.2.1 Servomex (0209093) were deleted

1351

Chap. 9.4.4: Water trap receptacle can be located on option plate (leon)

1352

Chap. 9.5.1: Replacement display leonplus supplemented by new distance pieces controllerboard (white, snap-in)

1353

Chap. 9.5.2: Replacement display leon supplemented by new front module leon (display and touch separated)

1354

Chap. 9.5.8: Replacement keypad leon not separate possible with new front module leon

1355

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Chap. 10.2: Configuration gas measurement supplemented by AION 01

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Chap. 10.9 and chap. 10.10: Configuration VueLink and serial protocol not possible if no protocol interface available.

08_Testing Version 2.1.3

09_Repairs

10_Configuration

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(Chapter 7.8.3.3) 100% Hardware calibration Servomex

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(Chapter 7.6.7, 7.6.8 and 7.6.9) changed due to a new Version Mixer PCB

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(Chapter 9.2.) Closer description to change pneumatic draw

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1231

(Chapter 9.15) Rebuilding option panel

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(Chapter 9.16) Internal connection workstation illumination

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(Chapter 9.14) Replacement/Rebuilding bronchial aspiration

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(Chapter 9.3) Replacement generator module

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