Services Manual SA Leon (Plus) 2 0 1b en [PDF]

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Service Manual leon leonplus

Rev.: 2.01b Date: 02.07.2007

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 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:

2.01b 02.07.2007 Heinen + Löwenstein®, Service Manual leon(plus) Rev. 2.01b

1

Contents

Revision 1 Contents 2 Safety and warning notices

2.03

3 Pneumatic / mechanical modules

2.03

4 Electronic modules

2.01

5 System software update

2.03

6 Maintenance

2.04

7 Calibration

2.04

Heinen + Löwenstein®, Service Manual leon(plus) Rev. 2.01b

Heinen + Löwenstein®, Service Manual leon(plus) Rev. 2.01b

Chapter 2: Safety and Warning Notices

2

Safety and warning notices

Contents Page 2.1

General information........................................................................................2-3

2.2

Follow user and service manuals...................................................................2-3

2.3

Warnings ........................................................................................................2-4

2.4

Maintenance...................................................................................................2-5

2.5

Liability for proper function or damage...........................................................2-5

2.6

Symbols .........................................................................................................2-6

2.7

Terms and abbreviations..............................................................................2-11

Figures Page - none -

Tables Page Table 1: Symbols/Labels.....................................................................................................2-6 Table 2: Symbols/Pushbuttons ...........................................................................................2-8 Table 3: Symbols/LEDs ......................................................................................................2-8 Table 4: Symbols/Screen (display only)..............................................................................2-9 Table 5: Symbols/Screen (control elements) ......................................................................2-9 Table 6: Icons/Buttons ......................................................................................................2-10 Table 7: Terms and abbreviations ....................................................................................2-11

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2-1

Chapter 2: Safety and Warning Notices

2.1

General information

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

2.2

Follow user and service manuals Use of this equipment requires full knowledge of and precise adherence to the supplied user 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.

Heinen + Löwenstein®, Service Manual leon(plus) Rev. 2.03

2-3

Chapter 2: Safety and Warning Notices

2.3

Warnings The leon(plus) anesthesia system may be operated only by qualified medical personnel who can interfere immediately, in case the system should fail. While the leon(plus) 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(plus) 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. Do not use the system with flammable gases or anesthetics due to risk of fire. An acoustic alarm indicates a system or patient alarm/alert/warning and requires immediate action by qualified medical personnel. If an error is detected during the system function test, the system may not be connected to a patient under any circumstances. Do not electrically connect the system to devices not mentioned in this manual without first consulting the manufacturers or a system expert. Do not cover the system or set it up such that its operation or function is impaired. Pull out the mains plug before opening the housing. 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.

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Chapter 2: Safety and Warning Notices

2.4

Maintenance1

The leon(plus) 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.) A 10.000-hour maintenance must be performed according to manufacturer specifications every 3 years or after 10.000 hours of operation. 3.) A 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

Table 1: Symbols/Labels Symbol

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. 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) Manometer for N2O reserve cylinder pressure label (on front)

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Chapter 2: Safety and Warning Notices

Table 1: Symbols/Labels Symbol

Description 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) External O2 outlet label External fresh gas outlet label with maximum pressure Pmax

ETH

Ethernet interface label

COM 1, COM 2

Label 1 and 2 for serial interface

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Chapter 2: Safety and Warning Notices

Table 2: Symbols/Pushbuttons Symbol

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

(manual

Display Loops window pushbutton Display alarm limits window pushbutton Call system test level and service level pushbutton (only available from standby) Start ventilation mode pushbutton Standby (switch to standby, stop ventilation) pushbutton Mute Alarm pushbotton for 2 or 10 minutes

Table 3: Symbols/LEDs Symbol

Description LED mains voltage present (lights green) LED battery operation (lights yellow) LED visual alarm display (lights red)

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Chapter 2: Safety and Warning Notices

Table 4: Symbols/Screen (display only) Symbol

Beschreibung 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 Alarm volume 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: Symbols/Screen (control elements) Symbol

Beschreibung 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.

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Chapter 2: Safety and Warning Notices

Table 6: Icons/Buttons Symbol

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 Increase alarm volume button Decrease alarm volume button Automatically adjust alarms button Open log button

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Chapter 2: Safety and Warning Notices

2.7

Terms and abbreviations

Table 7: Terms and abbreviations

Term, abbreviation

Description

Agent

Volatile anesthetic

AGS

Anesthetic Gas Scavenging System

AGS

Anesthetic gas aspirator

Air

Medical compressed air

APL valve

Adjustable Pressure Limitation

ATPS

Ambient Temperature, Pressure, Saturated 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

Inspection of a measurement device to check out the deviance to a (well knowen) standard.

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.

Enflourane, 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

I:E

Ratio of Inspiration to Expiration time

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Chapter 2: Safety and Warning Notices

Table 7: Terms and abbreviations

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

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

Laughing gas

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

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Chapter 2: Safety and Warning Notices

Table 7: Terms and abbreviations

Term, abbreviation

Description

PInsp

Target pressure for PCV

Plateau

Percentage plateau length during inspiration

PMean

Mean pressure in the airway

PPeak

Maximum pressure in the airway

PPlateau

Plateau pressure in the airway

Pressure Units

⇒ 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 mbar

= approx. 1 cmH2O

Pressure units (Standard)

⇒ 1 kPa x 100 ⇒ 1 Pa x 100

= 1 bar

PSV

Pressure Support Ventilation

Quan. Charts

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

Ratio System

for N2O as carrier gas is minimum concentration settings 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

UPS

Uninterrupted Power Supply

= 1 kPa x 100

= 1 mbar, approx. 1 cmH2O

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Chapter 2: Safety and Warning Notices

Table 7: Terms and abbreviations

Term, abbreviation

Description

Vapor

Anesthetic vaporizer

VT

Tidal volume

VTe

Expiratory tidal volume

VTi

Inspiratory tidal volume

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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 Module/Insert Rev001/002 leonplus................................................3-3 Gas Box Module/Insert Rev003 leonplus.......................................................3-4 Gas Box Module/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 Nitrous switch block (leonplus only) ........................................................3-10 Nitrous switch block V1.......................................................................3-10 Nitrous switch block V2.......................................................................3-11 Nitrous switch block V3.......................................................................3-12 Functional description of the nitrous switch block...............................3-13 Nitrous switch block V1 (schematics) .................................................3-14 Nitrous switch block V2 (schematics) .................................................3-15 Nitrous 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) .............................................................3-21 Drive gas generator (schematics)............................................................3-22

3.5 3.5.1

Fresh gas generator (leonplus only) ............................................................3-23 Fresh gas generator (schematics)...........................................................3-24

3.6 3.6.1

Rotameter block (leon only) .........................................................................3-25 Rotameter block (schematics) .................................................................3-26

3.7 3.7.1 3.7.2 3.7.3 3.7.4 3.7.5

Swing arm and docking................................................................................3-27 Swing arm................................................................................................3-28 Cartridge (closed loop system)................................................................3-30 Plateau valve ...........................................................................................3-31 Docking....................................................................................................3-32 Swing arm (schematics) ..........................................................................3-33

3.8 3.9 3.10 3.11

Characteristic curves for the pressure reducer ............................................3-35 Mechanical pressure limit.............................................................................3-37 Overall view of the pneumatics (leon) ..........................................................3-39 Overall view of the pneumatics (leonplus) ...................................................3-40

Figures Page Figure 1: Gas Box Module/Insert leonplus Rev001/002 .....................................................3-3 Figure 2: Gas Box Modul/ Insert e leonplusRev003 ...........................................................3-4 Figure 3: Gas Box Module/Insert leon Rev001 ...................................................................3-5 Figure 3: Connector block...................................................................................................3-6 Figure 4: Connector block V2 leonplus(schematics)..........................................................3-8 Figure 6: Connector block V3 leon/leonplus(schematics) ..................................................3-9 Figure 5: Nitrous switch block V1......................................................................................3-10 Heinen + Löwenstein®, Service Manual leon(plus) Rev. 2.03

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)...................................3-21 Figure 16: Drive gas generator (schematics) ....................................................................3-22 Figure 17: Valve block for the fresh gas generator (leonplus only)...................................3-23 Figure 18: Fresh gas generator (schematics) ...................................................................3-24 Figure 19: Rotameter block (leon only) .............................................................................3-25 Figure 20: Rotameter block (schematics) .........................................................................3-26 Figure 21: Swing arm........................................................................................................3-27 Figure 22: Swing arm........................................................................................................3-28 Figure 23: Swiveling connector block (tubing system) ......................................................3-29 Figure 17: Cartridge ..........................................................................................................3-30 Figure 18: Plateau valve ...................................................................................................3-31 Figure 26: Docking............................................................................................................3-32 Figure 27: Swing arm (schematics) ..................................................................................3-33 Figure 21: Functional/Operating principle of the plateau valve: ........................................3-37 Figure 22: Functional/Operating principle of the plateau valve .........................................3-38 Figure 30: Overall view of the pneumatics (leon)..............................................................3-39 Figure 31: Overall view of the pneumatics (leonplus) .......................................................3-40

Tables Page Table 1: Drive gas generator flow rates ............................................................................3-21 Table 2: Fresh gas generator flow rates ...........................................................................3-23

3-2

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Chapter 3: Pneumatic / mechanical modules

3.1

Gas Box Module/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

Nitrous switch block

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

VAC HP O2 manometer

HP(N2O) manometer

Figure 1: Gas Box Module/Insert leonplus Rev001/002

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3-3

Chapter 3: Pneumatic / mechanical modules

3.2

Gas Box Module/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

Nitrous switch block

Vacuum Adjustment

VAC HP O2 manometer

HP(N2O) manometer

Figure 2: Gas Box Modul/ Insert e leonplusRev003

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Chapter 3: Pneumatic / mechanical modules

3.3

Gas Box Module/Insert Rev001 leon The Gas box modul of the leon contains no nitrous switchblock.

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 Module/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 cartridge. The upper pressure regulator controls the control pressure (measured at TP1) for switchover to "Open System (OS slide valve) and between "automatic/manual" (AM1 slide valve). Gas box module

Item no. 0209500

The lower pressure regulator controls the control pressure (measured at TP2 for the surplus 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 B

Magnetic Valve D O2

N2O

AIR

Pressure regulator 1.2 bar AM1/AM2/OS

Pressure regulator 125 mbar Vent diaphragm (HM) Magnetic Valve C Figure 3: Connector block

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Chapter 3: Pneumatic / mechanical modules

3.3.1.1

Functional description of the connector block leon/leonplus

Solenoid Valve A:

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

Solenoid Valve B:

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

Solenoid Valve C:

Switches the control pressure for the vent diaphragm (HM) inside the cartridge.

Solenoid Valve D:

Enables the selection of a 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 cartridge 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 vent diaphragm must equal 125 hPa (cmH2O) to ensure a sufficiently fast reaction time. The setting adjustment is found on the upper 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 4: 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

Nitrous switch block (leonplus only)

3.3.2.1

Nitrous 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 module

Item no. 0209550

Inlets: AIR / N2O / O2

Pneumatic ventil Solenoid valve E (Switchover carrier gas)

Solenoid valve F (Emergency dosing)

Outlet carrier gas N2O/AIR

Outlet Emergency dosing

Pressure regulator AIR

Pressure regulator O2

Outlet O2 Flush

Outlet O2

Figure 5: Nitrous switch block V1

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Chapter 3: Pneumatic / mechanical modules

3.3.2.2

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

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

Solenoid valve E (Switchover carrier gas)

unused

Solenoid valve F (Emergency dosing)

Outlet carrier gas N2O/AIR Pressure regulator N2O

Ausgang Not Dosierung Outlet O2 Flush Outlet O2 Pressure regulator O2 Inlet AIR

Pressure reglator AIR

Figure 8: Nitrous switch block V2

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Chapter 3: Pneumatic / mechanical modules

3.3.2.3

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

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)

Pressure regulator carrier gas

Pneumatic Valve (AIR)

Magnetic Valve F (Emergency dosing)

Inlet:

Pressure regulator O2

N2O

O2

AIR

Magnetic Valve E (Umschaltung Trägergas)

Outlet carrier gas N2O/AIR

Outlet emergency dosing Outlet O2

Outlet O2 Flush

Figure 9: Nitrous switch block V3

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Chapter 3: Pneumatic / mechanical modules

3.3.2.4

Functional description of the nitrous switch block

Solenoid valve E:

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

Solenoid 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 charter Calibration)

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Chapter 3: Pneumatic / mechanical modules

3.3.2.5

Nitrous switch block V1 (schematics)

Figure 10: Nitrous switch block V1 (schematics)

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Chapter 3: Pneumatic / mechanical modules

3.3.2.6

Nitrous switch block V2 (schematics)

Figure 11: Nitrous switch block V2 (schematics)

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Chapter 3: Pneumatic / mechanical modules

3.3.2.7

Nitrous switch block V3 (schematics)

Figure 12: Nitrous switch block V3 (schematics)

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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(plus) is available with a number of variants. Pin Index connections or screw connections (DIN) are available. Figure 13 shows the Pin Index model. Gas box module

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

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. 0208950 Gas box module

Art.-Nr: 0208950

PS3

PS2

PS4

PS5

PS1

Figure 14: Actors Connector Board (pressure sensors)

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Chapter 3: Pneumatic / mechanical modules

3.3.4.1

Functional description of the pressure sensors

Important note! The views of the connector block diagram (pages 3-8 and 3-9) again illustrates 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(plus) 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(plus) 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)

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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 generator (leonplus only) The fresh gas generator produces the anesthetic/gas mixture using an electronic blender consisting of 2 valve benches, each with 9 vents for N2O/AIR und 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 generator 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 generator flow rates

Fresh gas outlet

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

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Chapter 3: Pneumatic / mechanical modules

3.5.1

Fresh gas generator (schematics)

Figure 18: Fresh gas generator (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 generator.

Rear view leon

Art.-Nr: 0208800

Fresh Gas outlet

AIR inlet N2O inlet O2 inlet

Figure 19: Rotameter block (leon only)

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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

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

LEON PLUS

Exp. Insp. AGS DOM (bellow)

BAG Absorber

Figure 21: Swing arm

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Chapter 3: Pneumatic / mechanical modules

3.7.1

Swing arm The swiveling connector block establishes all the connections to the cartridge, except for the plateau valve (Voice Coil 1).

Swing arm

Fresh Gas (FG) Pressure measurement (Paw) Switchover open

Surplus Diaphragm (HM)

Voice Coil 2 PEEP

Switchover Auto/Manual

Pressure measurement (Paw)

Fresh Gas (FG) Surplus Diaphragm (HM)

Flow sensors connectors

Figure 22: Swing arm

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Chapter 3: Pneumatic / mechanical modules

Tubing:

Swing arm

Figure 14 illustrates how to thread the tubing through the swiveling connector block. When attaching the cover, make sure that none of the tubes is crimped or bent.

CAUTION! 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)

Surplus Diaphragm (HM)

Figure 23: Swiveling connector block (tubing system)

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Chapter 3: Pneumatic / mechanical modules

3.7.2

Cartridge (closed loop system) The leon(plus) 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 generator and the anesthetic vaporizer. The cartridge contains the full closed loop system!

Swing arm

Tube Connection Expiration

Tube Connection Inspiration

Absorber connection

Bellows connection

Figure 24: Cartridge

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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).

Swing arm

The movability of the block in the dovetail guide of the rotating support should be checked during annual maintenance. The O ring should be replaced annually due to the increased mechanical wear and tear from the swing arm.

Drive Gas Inlet Rotating support

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

While the plateau valve (1) is in direct contact with the cartridge, all the other pneumatic connections are made via the swiveling connector block.

3

Auto/Man. switch

4

Fresh gas (FG)

5

Airway pressure (Paw) Vent/Overflow diaphragm (HM)

6

The HP (high pressure) port provides the control pressures for the "auto/manual" switch (3) and the "open system" (2)/ The LP port delivers the fresh gas (4) and the control pressure for the surplus diaphragm (6). Additionally, the airway pressure (5) is guided to the pressure sensors inside the device. All the O rings between the ports and the swiveling connector block and between the plateau valve and the cassette are subject to increased mechanical wear and tear from the movement of the swing arm 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 5

Figure 26: Docking

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Chapter 3: Pneumatic / mechanical modules

3.7.5

Swing arm (schematics)

Figure 27: Swing arm (schematics)

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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 not only controls 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 not only controls the endexpiratory airway pressure but at the same time ensures the mechanical limit of the maximum possible airway pressure.

One-way valves inside the closed loop system (cartridge): All the one-way 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 4.8.1 4.8.2 4.8.3

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

4.9 4.10

Overall electronic layout (leon).....................................................................4-19 Overall electronic layout (leonplus) ..............................................................4-21

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 generator board ..............................................................................4-14 Figure 13: Overall electronic layout (leon) ........................................................................4-19 Figure 14: Overall electronic layout (leonplus)..................................................................4-21

Tables Page -none -

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4-1

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(plus) simultaneously via an input filter. Both inlet fuses (2x2AT) secure/protect the electronics of the leon(plus) 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 The AC/DC converter is installed on the hinged rear wall. The Master Module supplies the leon(plus) control directly via the Adapter Board. The Slave Module supplies the cartridge heater via the Actors Connector Board. It is triggered by the Slave Module's inhibit input. Rear view

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.

CAUTION! Item no.: 0209605

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

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 Module

Art.-Nr.: 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(plus). Both PIC processors control and monitor it. Both communicate through different routes/transmission paths with the user interface.

Rear view

While the control 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

Control PIC Monitor PIC

Backup battery Pressure sensor PS8 Figure 7: Main board

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Chapter 4: Electronic modules

4.4.1

Main board (diagram)

Figure 8: Main board (diagram)

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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

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Chapter 4: Electronic modules

4.7

Fresh gas generator board The Fresh Gas Generator 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. 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.

Blender boards

Pressure sensor type S2: XPCL04DTC

Item no.: 0208751-2

Pressure difference sensor (S2) Fresh gas outlet

Figure 12: Fresh gas generator board

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Chapter 4: Electronic modules

4.8

4.8.1

Measurement Systems

Measurement accuracy of the pressure sensors

Pressure sensors for airway pressure and blender inlet pressure: Manufacturer data sheet excerpt:

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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)

4.8.2

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

Overview electronic measurement processing of the pressure sensors: (note: I would move Overview to the end) 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) Sensor PS7 PS8

4-16

Measurement range - 52 to 1262 mmH2O -96 to 1157 mmH2O

Display cmH2O / 1 cmH2O cmH2O / 1 cmH2O

Measurement tolerance 0.1 cmH2O 0.1 cmH2O

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Chapter 4: Electronic modules

4.8.3

•

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 and the peep valves.

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Chapter 4: Electronic modules

4.9

Overall electronic layout (leon)

Figure 13: Overall electronic layout (leon)

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Chapter 4: Electronic modules

4.10

Overall electronic layout (leonplus)

Figure 14: Overall electronic layout (leonplus)

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Chapter 4: Electronic modules

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Chapter 5: Update Systemsoftware

5

Update Systemsoftware

Contents Seite 5.1 5.1.1 5.1.2 5.1.2.1 5.1.2.2 5.1.2.3 5.1.2.4 5.1.2.5 5.1.3 5.1.3.1 5.1.3.2 5.1.3.2.1 5.1.3.2.2 5.1.3.2.3 5.1.3.3

Software Update ............................................................................................5-3 Required materials ....................................................................................5-4 Preliminary steps .......................................................................................5-4 PC preparation......................................................................................5-4 leon(plus) preparations .........................................................................5-6 Update environment setup (Update with Kernel) ..................................5-9 Update environment setup (Update without Kernel) ...........................5-10 Update environment setup (Power PIC) .............................................5-10 Procedure ................................................................................................5-11 Update NETDCU (with kernel) + CFB Firmware ................................5-11 Update NETDCU (without kernel) + CFB Firmware............................5-11 Script 1 (kernel installation) execution:...........................................5-12 Script 2 execution (delete old system version)...............................5-14 Script 3 execution (transfer update to leonplus):............................5-15 Power-Pic update................................................................................5-16

Figures Seite Figure 1: Software update (network settings Windows 2000/XP) .......................................5-5 Figure 2: Determining the existing software versions .........................................................5-6 Figure 3: Determining the flow correction factor .................................................................5-6 Figure 4: Determining device configuration ........................................................................5-7 Figure 5: Determining user configuration............................................................................5-7 Figure 6: Script 1 execution (page 1)................................................................................5-12 Figure 7: Script 1 execution (page 2)................................................................................5-13 Figure 8: Script 2 execution ..............................................................................................5-14 Figure 9: Script 3 execution ..............................................................................................5-15 Figure 10: Power PIC update (page 1) .............................................................................5-16 Figure 11: Power PIC update (page 2) .............................................................................5-17

Tables Seite Table 1: Software Update Form leon(plus).........................................................................5-8

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Chapter 5: Update Systemsoftware

5.1

Software Update

The software for the different hardware modules of the leon(plus) are usually delivered as a package and require no further customization. Usually the installation is to be/The installation is normally/ carried out according to the instructions; exceptions are documented separately. The printed Screens shows the software of the leonplus. The actual display on the unit can by different to the illustration in this service-manual.

CAUTION! •

During the software update no patient may be connected to the device!

•

Ensure that the leon(plus) as well as the PC or the notebook used is connected to the power supply! The update may not be carried out while the device operates in battery mode.

•

Under no circumstances may the update be interrupted or terminated as the hardware may be severely damaged.

•

A firewall installed on the PC or notebook may possibly block the data exchange necessary for the update. Configure the firewall accordingly or deactivated it for the update. Please contact your system administrator, if necessary.

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Chapter 5: Update Systemsoftware

5.1.1

Required materials

The following accessories are required for the software update: •

PC or notebook with Ethernet interface (10/100Mbit) and serial (RS232) interface (use USB adapter, if applicable).

•

Crossed Ethernet network cable (crossover, Cat. 5)

•

Current software version

•

Internet Explorer 5.5 or higher (includes Windows Scripting Host)

•

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 .

5.1.2

Preliminary steps

5.1.2.1

PC preparation

CAUTION! Ensure that the firewall on your PC is either configured accordingly or completely deactivated. •

Create a directory for the current software version on your PC or notebook. ( example: \Leon Plus 2_0_1i\ ) The directory used must be empty in order avoid conflicts with old or third party data.

•

Save all files of the software package received in this directory. If you have the software package as zip file, decompress it beforehand and save the decompressed contents in this directory. The zip file itself /does not belong to/is not part of/ the update.

•

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: For Windows XP, English: • •

"Start" - open "Control Panel" open "Network Connections"

For Windows 2000, English: •

5-4

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

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Chapter 5: Update Systemsoftware

Continued/Continuation (both operating systems): • • • • • • • • • •

Right click the "Local Area Connection" icon Select "Properties" "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"

•

Connect the device directly with a crossover network cable (Ethernet) directly to your PC.

•

Turn the device on and wait until it has started completely.

Figure 1: Software update (network settings Windows 2000/XP)

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Chapter 5: Update Systemsoftware

5.1.2.2

leon(plus) preparations

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

Software versions of the system components

Figure 2: Determining the existing software versions

Write down all the 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 components versions different from those in the "Version.txt" must be updated.

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

Write down the correction factor of the flow measurement, in order to restore after the update.

Figure 3: Determining the flow correction factor

5-6

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Chapter 5: Update Systemsoftware

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 4: Determining device configuration

Determining user settings: Switch to the ventilation screen:

5

4

3

1

2 Figure 5: 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.

Important note! Use the form on the next page to collect the values.

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5-7

Chapter 5: Update Systemsoftware

Software Update Form leonplus System configuration Flow correction factor Gas measurement PPeak alarm Gas supply Man./Spont.

Serial number leonplus (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) (Standard 30s)

AION mmHg

Other: active %

Air CGS

O2 Cylinder

CGS

Cylinder

inactive

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

Version (old)

Version (new)

Fresh gas settings Carrier gas O2 concentration Fresh gas flow

Child

Adult

Ventilation settings Ventilation mode

Child

AIR

N2O

N2O

Adult

IMV PCV IMV

AIR

S-IMV S-PCV SIMV

PCV

IMV PCV

PSV S-PCV

PSV

IMV

S-IMV S-PCV SIMV

PCV

PSV S-PCV

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

Adult Low

High

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

Parameter page 1

Parameter page 2

(Standard: MV)

(Standard: MV)

(Standard: VTe)

(Standard: VTe)

(Standard: PPeak

(Standard: PPeak

(Standard: PPlateau)

(Standard: PPlateau)

(Standard: MAC)

(Standard: PMean)

(Standard: Compl.)

(Standard: Peep)

(Standard: C20/C)

(Standard: Freq.)

(Standard: Resistance)

(Standard: Compl.)

Graphs Graph 1 Graph 2 Graph 3 Graph 4

Y axis scale

Time axis scale

Table 1: Software Update Form leon(plus)

5-8

none

Heinen + Löwenstein®, Service Manual leon(plus) Rev. 2.03

Low

PSV

Chapter 5: Update Systemsoftware

5.1.2.3

Update environment setup (Update with Kernel)

For all updates (NET-DCU, CFB Firmware) that require a kernel update (Windows CE platform) the following setup is necessary:

X15 (RJ45)

NET DCU

X27 (RJ45) Controller board

Zero modem adapter

Serial cable (RS232) Item no. 0170503

Crossover network cable (Cat. 5)

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

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5-9

Chapter 5: Update Systemsoftware

5.1.2.4

Update environment setup (Update without Kernel)

For all updates (NET-DCU, CFB Firmware) that DO NOT require a kernel update (Windows CE platform) the following setup is necessary:

RJ45

Crossover Network Cable (Cat. 5)

5.1.2.5

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

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Chapter 5: Update Systemsoftware

5.1.3

5.1.3.1

Procedure

Update NETDCU (with kernel) + CFB Firmware

For the NET-DCU (user interface) update including the kernel, you will need the following update scripts:

1_NETDCU_setup.vbs

3_SYSTEM_Update.vbs

Script 2 (2_SYSTEM_Delete.vbs) is not needed, as the old system version is deleted entirely when the kernel is updated. Execute the scripts 1 and 3 according to the instructions in the following chapters.

5.1.3.2

Update NETDCU (without kernel) + CFB Firmware

For the NET-DCU (user interface) update without the kernel, you will need the following update scripts:

2_SYSTEM_delete.vbs

3_SYSTEM_Update.vbs

Script 1 (1_NETDCU_setup.vbs) is not required for this. Execute the scripts 2 and 3 according to the instructions in the following chapters.

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Chapter 5: Update Systemsoftware

5.1.3.2.1

Script 1 (kernel installation) execution:

Start Script "1 NETDCU setup.vbs"

If an error during opening the COM interface occurs, proceed as follows:

Do NOT click on "OK" in the dialog field and do not close the hyper terminal!

Click the mouse in the Hyperterminal-Window.

Select "Properties" in the "File" menu

Press "Shift" and hold down the "S" button while you switch on leonplus

Click on "OK" after the message "Unknown Command" appears

Dialog box

Select the correct COM interface

Click on the telephone symbol, to reconnect Switch leonplus off and on again

Figure 6: Script 1 execution (page 1)

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Chapter 5: Update Systemsoftware

Click on "OK" after the message "NetDCU – WindowsCE Bootloader" appears Select current NetDCU by double-clicking it

Open subdirectory "Kernel" in the update directory

Close EShell, when the message "ready" appears Close hyper terminal

Terminate connection

Start Script 3 immediately, without starting leonplus again. Figure 7: Script 1 execution (page 2)

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5-13

Chapter 5: Update Systemsoftware

5.1.3.2.2

Script 2 execution (delete old system version)

Start Script „2_SYSTEM_delete.vbs“ by doubleclicking it

Wait until leonplus is started up (system test button visible). Then click "OK".

Switch leonplus off and on again.. Then click "OK“.

1 minute aprox.

Wait for the next message! It takes about 1 minute until the old system software is deleted. During this time, the computer seems to be inactive, thus it is imperative to wait for the next message, before you continue the update

Click "OK" to end Script 2

Start Script 3 immediately, without starting leonplus again.

Figure 8: Script 2 execution

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Chapter 5: Update Systemsoftware

5.1.3.2.3

Script 3 execution (transfer update to leonplus): CAUTION! Start Script „3_SYSTEM_Update.vbs“ by d bl li ki it

2-3 minutes aprox.

Before Script 3 is executed, either Script 1 or Script 2 must have been executed, in order to free sufficient storage space on the leonplus to receive the update files.

The update files are automatically transferred to the leonplus via FTP. The transfer takes about 23 minutes. During this period, it might look like the update process is stuck. Do not terminate the update process under any circumstances! Wait for the following message.

Switch leonplus off and on again

Wait, until the update process on the leonplus is completed. This process may not be terminated under any circumstances. Restart the device, software is installed

when

prompted.

The

Figure 9: Script 3 execution

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5-15

Chapter 5: Update Systemsoftware

5.1.3.3

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 10: Power PIC update (page 1)

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Chapter 5: Update Systemsoftware

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 11: Power PIC update (page 2)

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5-17

Chapter 5: Update Systemsoftware

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Heinen + Löwenstein®, Service Manual leon(plus) Rev. 2.03

Chapter 6: Maintenance

6

Maintenance

Contents Page 6.1

Intervals..........................................................................................................6-3

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 6.2.4 6.2.5 6.2.6 6.2.6.1 6.2.6.2 6.2.6.3 6.2.6.4 6.2.6.5 6.2.6.6 6.2.6.7 6.2.6.8 6.2.6.9 6.2.6.10 6.2.6.11 6.2.6.12

Annual maintenance ......................................................................................6-5 Required tools ...........................................................................................6-5 Internal modules (annual maintenance) ....................................................6-6 Opening the rear panel..............................................................................6-8 Vaporizer holder....................................................................................6-9 O-Ringe water trap holder...................................................................6-10 Replacement internal O2 measurement cell (fresh gas) .....................6-11 Bacteria filter pressure sample line.....................................................6-12 Closing the rear panel.........................................................................6-13 Anesthetic vaporizer ................................................................................6-14 Swiveling connector (docking).................................................................6-15 Cartridge (closed loop system)................................................................6-18 Preparation of the cartridge ................................................................6-19 Bellow holder ......................................................................................6-20 Absorber .............................................................................................6-21 Flow Sensors ......................................................................................6-22 Slide valve (Cartridge bottom) ............................................................6-23 Absorber rotary valve..........................................................................6-24 PEEP Valve ........................................................................................6-25 Emergency air valve ...........................................................................6-26 Insp. / Exp. check valve ......................................................................6-27 Slide valve (Cartridge top) ..................................................................6-28 APL valve............................................................................................6-29 O-rings sight glasses ..........................................................................6-30

6.3 6.3.1 6.3.2 6.3.3 6.3.4

10,000 hr. Maintenance (every 3 years) ......................................................6-31 Required tools .........................................................................................6-31 Replacing the batteries............................................................................6-33 Replacing device fuses............................................................................6-34 Vaporizer holder ......................................................................................6-35

6.4 6.4.1 6.4.2 6.4.2.1 6.4.2.2 6.4.3 6.4.4

20,000 hr. Maintenance (every 6 years) ......................................................6-37 Required tools .........................................................................................6-37 High pressure connections (pressure reducer) .......................................6-38 Removing the gas box ........................................................................6-40 Replacing the high pressure connections ...........................................6-41 Replacing pressure regulators connector block ......................................6-43 Replacing pressure regulators nitrous switch block ................................6-44

Figures Page Figure 1: Opening the rear panel ........................................................................................6-8 Figure 2: Internal modules ..................................................................................................6-8 Figure 3: Vaporizer holder ..................................................................................................6-9 Figure 4: Selectatec gaskets...............................................................................................6-9 Figure 5: Position water trap holder .................................................................................6-10 Figure 6: O-rings water trap holder ...................................................................................6-10 Figure 7: O2 cell drive gas generator ................................................................................6-11 Heinen + Löwenstein®, Service Manual leon(plus) Rev. 2.04

6-1

Chapter 6: Maintenance

Figure 8: Bacteria filter pressure sample line....................................................................6-12 Figure 9: Close the rear panel ..........................................................................................6-13 Figure 10: Close the rear panel ........................................................................................6-13 Figure 11: Swiveling connector cushioning rings ..............................................................6-16 Figure 12: Swiveling connector sealing rings....................................................................6-17 Figure 13: Plateau valve sealing ring................................................................................6-17 Figure 14: Removing APL, domes ....................................................................................6-19 Figure 15: Removing the absorber ...................................................................................6-19 Figure 16: Removing the cartridge....................................................................................6-19 Figure 17: Removing the bellows......................................................................................6-20 Figure 18: Disassembling the absorber receptacle...........................................................6-20 Figure 19: Bellows holder .................................................................................................6-20 Figure 20: Absorber ..........................................................................................................6-21 Figure 21: Flow Sensors ...................................................................................................6-22 Figure 22: Slide valve Cartridge bottom............................................................................6-23 Figure 23: Absorber ball valve ..........................................................................................6-24 Figure 24: PEEP Valve .....................................................................................................6-25 Figure 25: Emergency air valve ........................................................................................6-26 Figure 26: Inspiration/Expiration valve ..............................................................................6-27 Figure 27: Slide valve (Cartridge top) ...............................................................................6-28 Figure 28: APL valve.........................................................................................................6-29 Figure 29: Valve domes assembly ....................................................................................6-30 Figure 30: Rear panel of battery compartment .................................................................6-33 Figure 31: Disconnecting the batteries .............................................................................6-33 Figure 32: Connecting the batteries..................................................................................6-34 Figure 33: Replace fuses ..................................................................................................6-34 Figure 34: Vaporizer holder ..............................................................................................6-35 Figure 35: Check valve .....................................................................................................6-35 Figure 36: Removing the gas box .....................................................................................6-40 Figure 37: Detach high pressure connections ..................................................................6-41 Figure 38: Removing the high pressure connections........................................................6-41 Figure 39: Replacing the high pressure connection..........................................................6-42 Figure 40: Pressure regulators connector block ...............................................................6-43 Figure 41: Pressure regulators nitrous switch block .........................................................6-44

Tables Page Table 1: Contents of annual maintenance kit for internal modules .....................................6-6 Table 2: Internal module replacement parts .......................................................................6-7 Table 3: Contents of swiveling connector maintenance kit ...............................................6-15 Table 4: Swiveling connector replacement parts ..............................................................6-15 Table 5: Contents of cartridge maintenance kit ................................................................6-18 Table 6 : Contents of maintenance kit for 10,000 hr. maintenance (Item no. 0209066) ...6-32 Table 7: 6 Year maintenance kit high pressure PIN-Index (0209070) ..............................6-38 Table 8: 6 Year maintenance kit high pressure DIN (0209075) ........................................6-38 Table 9: 6 Year maintenance kit high pressure PIN-Index without N2O (0209070-1) .......6-38 Table 10: 6 Year maintenance kit high pressure DIN without N2O (0209075-1)...............6-38 Table 11: Gas box replacement parts ...............................................................................6-39

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Chapter 6: Maintenance

6.1

Intervals

Every 12 months (maintenance): • • •

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

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

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

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

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

Heinen + Löwenstein®, Service Manual leon(plus) Rev. 2.04

6-3

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 anesthetic gases) and that cannot be replaced by the operating personnel should be replaced during annual maintenance.

CAUTION! 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)

•

Phillips screwdriver (size 1)

•

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

•

Pliers for inner retaining rings

Materials required: •

Internal module maintenance kit (Item no. 0209060)

•

Cassette maintenance kit (Item no. 0209050)

•

Swiveling connector maintenance kit (Item no. 0209055)

•

Oxygen grease (Item no. 0150042)

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6-5

Chapter 6: Maintenance

6.2.2

Internal modules (annual maintenance)

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

Quan.

Item no.

Description

Rear panel

1

0209608

Filter for fan leon / leonplus

Vaporizer holder

4

0020005-1

O-ring ckeck valve vaporizer

Generator module

1

0208766

Oxygen cell leon / leonplus

Gas measurement

2

0020166

O-rings for dryline receptacle

1

369-0343-00

Bacteria filter for pressure sample line

Table 1: Contents of annual maintenance kit for internal modules

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Chapter 6: Maintenance

Internal module replacement 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)

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

Generator module

Front module

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 generator (complete)

1

0208751-1

Fresh gas generator (w/o board)

1

0208751-2

Fresh gas generator 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

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

Options panel

Table 2: Internal module replacement parts

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6-7

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

Important note! 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 10,000 hr or 20,000 hr maintenance).

Danger of electrical shock! Some tasks require that the open device be running. Unplug the leon(plus) 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

Vaporizer holder

The outer O-rings of the vaporizer 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: Vaporizer 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 ckeck valve 1 4 0020005-1 vaporizer Figure 4: Selectatec gaskets

Important note! Check whether there are other necessary work steps in addition to annual maintenance (for 10,000 hr or 20,000 hr maintenance refer to step 6.3.4 on page 6-35).

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6-9

Chapter 6: Maintenance

6.2.3.2

O-Ringe water trap holder

If The unit comes with a water trap holder (A) the outer O-rings needs to be replaced annually.

A

Figure 5: Position water trap holder

1

1

Figure 6: O-rings water trap holder

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

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Chapter 6: Maintenance

6.2.3.3

Replacement internal O2 measurement cell (fresh gas)

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

Important note! 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).

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

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6-11

Chapter 6: Maintenance

6.2.3.4

Bacteria filter pressure sample line

Replace the bacteria filter (1) in the pressure sample line of the device

1

Figure 8: Bacteria filter pressure sample line

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

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Chapter 6: Maintenance

6.2.3.5

Closing the rear panel

Close the rear panel when all the maintenance and calibration tasks are complete. 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 9: Close the rear panel

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

A B

Figure 10: Close the rear panel

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6-13

Chapter 6: Maintenance

6.2.4

Anesthetic vaporizer

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

CAUTION! Conduct all necessary maintenance and service work on the anesthetic vaporizers as specified in the manufacturer's service documents.

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Chapter 6: Maintenance

6.2.5

Swiveling connector (docking)

Swiveling connector maintenance kit (Item no.: 0209055): Quan.

Item no.

Description

1

0020054

O-ring gas supply (freshgas)

4

0020119

O-ring für gas supply

1

0020156

O-ring 18 x 2.5 (plateau valve)

6

0020168

O-ring for connection mandril (small)

2

0020170

O-ring for connection mandril (big)

Table 3: Contents of swiveling connector maintenance kit

Swiveling connector replacement parts: Quan.

Item no.

Description

7

0020159

O-ring damping cartridge

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: Swiveling connector replacement parts

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6-15

Chapter 6: Maintenance

Important note! The O-rings located directly in the recesses on the top of the swiveling connector 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 leon(plus) is even safe to run without these O-rings. However, missing or damaged rings must be replaced with new Orings.

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

A A

A

Figure 11: Swiveling connector cushioning rings

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Chapter 6: Maintenance

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

Swiveling Connector

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 0020170 mandrel (big) O-ring gas supply 4 1 0020054 (freshgas) O-ring exhalation valve 5 1 0020156 docking station

4 1

3

1

2 2 Figure 12: Swiveling connector sealing rings

5

Figure 13: Plateau valve sealing ring

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6-17

Chapter 6: Maintenance

6.2.6

Cartridge (closed loop system)

Cartridge maintenance kit (Item no. 0209050): Cartridge bottom

Cartridge bottom/top

Cartridge top

Absorber

Quan. 1 1 2 4 1 1 1 1 1 1

Item no. 0020000 0020096 0020148 0020156 0020158 0020202 0020203 0020500 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 Flat gasket bellow holder Diaphragm emergency air valve PEEP valve diaphragm

9 3 3

Item no. 0020138 0020140 0020141

Description O-ring for piston (big) O-ring for piston (small) O-ring for cover / piston

1 2 2 2 2

Item no. 0020046 0020162 0020167 0020206 0209106

Description O-ring APL-bayonet fitting O-ring for sight glass O-ring for valve seat for insp. / exp. O-ring for APL valve Flap valve

1 1

Item no. 0020153 0020163

Description O-ring absorber outside Flat gasket inside for absorber

Quan.

Quan.

Quan.

Table 5: Contents of cartridge maintenance kit

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Chapter 6: Maintenance

6.2.6.1

Preparation of the cartridge

Open the swing arm with the cartridge. Unscrew the APL valve (A) and both domes (1) from the top of the cartridge.

B B

A

Figure 14: Removing APL, domes

Remove the absorber (C)!

C Figure 15: Removing the absorber

Release the lock and take the cartridge out of the swing arm

D

Figure 16: Removing the cartridge

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6-19

Chapter 6: Maintenance

Next, remove the chamber and the bellows (F)

E Figure 17: Removing the bellows

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

F

H

G

Figure 18: Disassembling the absorber receptacle

6.2.6.2

Bellow holder Replace the flat gasket (1).

Cartridge bottom

1

The following components must be replaced: No. Quan. Item no. Description 1 1 0020500 Flat gasket bellow holder

Figure 19: Bellows holder

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Chapter 6: Maintenance

6.2.6.3

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

2

Absorber

The following components must be replaced: No. Quan. Item no. Description 1 1 0020153 O-Ring absorber autside 2 1 0020163 Flat gasket inside for absorber

Figure 20: Absorber

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6-21

Chapter 6: Maintenance

6.2.6.4

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 and the O-rings (2) between the sensors and tube connections. Cartridge bottom

1 A

B

1 Figure 21: 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

6.2.6.5

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

A Cartridge 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 / piston 2 1 0020140 O-Ring for piston (small) 3 3 0020138 O-Ring for piston (big)

3

CAUTION!

1

The O-rings should be treated with a special oxygen grease to reduce friction and increase tightness. 2

Figure 22: Slide valve Cartridge bottom

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6-23

Chapter 6: Maintenance

6.2.6.6

Absorber rotary valve Replace all existing O-rings on the under 6.2.6.1 dismantled ball valve (A).

B A Cartridge 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 1

CAUTION! The O-rings should be treated with a special oxygen grease to reduce friction and increase tightness.

4 3 2 (4x)

Figure 23: Absorber ball valve

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Chapter 6: Maintenance

6.2.6.7

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

A

B

Cartridge bottom

A

B

The following components must be replaced: No. Quan. Item no. Description PEEP valve diaph1 1 0209109 ragm O-ring bayonet fitting 2 1 0020203 PEEP 1

2

Figure 24: PEEP Valve

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6-25

Chapter 6: Maintenance

6.2.6.8

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 cartridge part.

D C

Cartridge bottom

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 25: Emergency air valve

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Chapter 6: Maintenance

6.2.6.9

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 Flap valve O-ring for valve seat 2 2 0020167 insp. / exp. Cutoff the two fixing pins (D) of the flap valve directly below the cone.

1

D

2

2x Figure 26: Inspiration/Expiration valve

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6-27

Chapter 6: Maintenance

6.2.6.10

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

Cartridge 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 2 2 0020140 O-ring for piston (small) 3 6 0020138 O-ring for piston (big)

CAUTION!

1

The O-rings should be treated with a special oxygen grease to reduce friction and increase tightness. 3

Figure 27: Slide valve (Cartridge top)

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2

Chapter 6: Maintenance

6.2.6.11

APL valve

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

Cartridge 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 28: APL valve

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6-29

Chapter 6: Maintenance

6.2.6.12

O-rings sight glasses

1 1

2

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

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

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

Figure 29: Valve domes assembly

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Chapter 6: Maintenance

6.3

10,000 hr. Maintenance (every 3 years)

The leon(plus) 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.

CAUTION! During the 10,000 hr. maintenance, all components and modules are replaced that are not guaranteed to operate for more than 10,000 hours. All the work steps for the annual maintenance are also performed!

ESD Hazard! Make sure you take steps to reduce the ESD hazard to the leon(plus) components and modules prior to starting maintenance work. Work steps that require special attention are marked accordingly with symbols.

6.3.1

Required tools

Tools required: •

For tools required for annual maintenance, refer to Page 6-5

•

Slotted screwdriver (size 1.2 x 6.5 mm)

Materials required: •

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

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6-31

Chapter 6: Maintenance

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

Quant. Item no. 2 0208700

Batteries

20 0170024

Rear panel

Description Leon (Plus) batteries Fuse 2AT (5 x 20 mm) (quantity 11 required)

Vaporizer-Holder

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 : 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 back panel.

A

B

Figure 30: Rear panel of battery compartment

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 31: Disconnecting the batteries

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

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6-33

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 32: Connecting the batteries

CAUTION! Switching the battery connections can cause severe damage to the leon(plus)! To reassemble, follow the instructions for disassembly in reverse.

6.3.3

Replacing device fuses

Replace the device fuses (1) in the rearpanel (B). Eleven must be replaced.

1 B

Figure 33: Replace fuses

The following components must be replaced: No. Quan. Item no. Description 1 2 0170024 Fuse 2AT (5 x 20mm)

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Chapter 6: Maintenance

6.3.4

Vaporizer holder

Uncase the 4 check valves (A). Therfore firstly unscrew the 4 screws in the underside of the Vaporizer holder. The screws are accessable from inside the device.

A

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

Figure 34: Vaporizer holder

1

5

2

5

4

3

Figure 35: 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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6-35

Chapter 6: Maintenance

6.4

20,000 hr. Maintenance (every 6 years)

The leon(plus) 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.

CAUTION! During the 20,000 hr. maintenance, all components and modules are replaced that are not guaranteed to operate for more than 20,000 hours.

6.4.1

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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6-37

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..

Item-no.

Description

1 0209553

Pressure regulator connector block bottom

1 0209554

Pressure regulator connector block top

2 0209556

Pressure regulator nitrous switch block

1 0341006

O2 pressure reducer (generally Pin Index)

1 0341016

N2O pressure reducer (generally Pin Index)

Table 7: 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.

Item-no.

Description

1 0209553

Pressure regulator connector block bottom

1 0209554

Pressure regulator connector block top

2 0209556

Pressure regulator nitrous switch block

1 0341001

O2 pressure reducer (generally DIN)

1 0341011

N2O pressure reducer (generally DIN)

Table 8: 6 Year maintenance kit high pressure DIN (0209075)

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.

Item-no.

Description

1 0209553

Pressure regulator connector block bottom

1 0209554

Pressure regulator connector block top

2 0209556

Pressure regulator nitrous switch block

1 0341006

O2 pressure reducer (generally Pin Index)

Table 9: 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.

Item-no.

Description

1 0209553

Pressure regulator connector block bottom

1 0209554

Pressure regulator connector block top

2 0209556

Pressure regulator nitrous switch block

1 0341001

O2 pressure reducer (generally DIN)

Table 10: 6 Year maintenance kit high pressure DIN without N2O (0209075-1)

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Chapter 6: Maintenance

Gas box replacement 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 11: Gas box replacement parts

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6-39

Chapter 6: Maintenance

6.4.2.1

Removing the gas box

CAUTION! Make sure that the system is completely disconnected from the gas supply before starting the work steps. You must remove all the 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!

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 36: Removing the gas box

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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 37: 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 38: Removing the high pressure connections

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6-41

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 39: Replacing the high pressure connection

CAUTION! 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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Chapter 6: Maintenance

6.4.3

Replacing pressure regulators connector block Replace both pressure regulators in the connector block. Therefore lose the screws (A).

1

gas box

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 40: Pressure regulators connector block

CAUTION ! After replacing the pressure regulators in the connector block perform a calibration of the pilot pressure (see chapter calibration), before you insert the cartridge in the device. If the pilot pressure is too high, the surplus diaphragm can get destroyed.

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6-43

Chapter 6: Maintenance

6.4.4

Replacing pressure regulators nitrous switch block Replace both pressure regulators (1) in the switchblock. Therefore lose the screws (A). In case of the revision of the switch block you will find the pressure regulators in different positions

A

gas box

1

A

switch block Rev. 01/02 A

CAUTION! After the replacement of the pressure regulators in the switch block perform a calibration of the fresh gas blender inlet pressures (see chapter calibration).

A 1

switch block Rev. 03 The following components must be replaced: No. Quan. Item no. Description 1 2 0209556 Pressure regulator switch block Figure 41: Pressure regulators nitrous switch block

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Chapter 7: Calibration

7

Calibration

Contents Page 7.1

Intervals..........................................................................................................7-3

7.2

Differences leon / leonplus.............................................................................7-4

7.3

Required tools and testing equipment............................................................7-5

7.4

Test setup for flow measurement / calibration ...............................................7-6

7.5

Test setup for pressure monitor/calibration....................................................7-7

7.6 7.6.1 7.6.2 7.6.3 7.6.4 7.6.5 7.6.6 7.6.7 7.6.8

Hardware calibration ......................................................................................7-8 Fresh gas blender inlet pressures (O2/AIR) – Gas box Rev001 ................7-9 Fresh gas blender inlet pressure (O2/AIR/N2O) – Gas box Rev002 ........7-10 Fresh gas blender inlet pressures (O2/AIR/ N2O) – Gas box Rev003 .....7-12 Pilot pressure slide valves .......................................................................7-13 Pilot pressure surplus diaphragm ............................................................7-14 Hardware calibration for airway pressure measurement .........................7-15 Hardware calibration of inlet drive gas generator ....................................7-16 Hardware calibration of fresh gas flow monitor .......................................7-18

7.7 7.7.1 7.7.2 7.7.3 7.7.4

System software calibration .........................................................................7-19 Flow sensor calibration............................................................................7-20 Calibration of FiO2 measurement cell ......................................................7-22 Calibration of the fresh gas O2 measurement cell....................................7-23 Calibration of pressure sensor.................................................................7-24

7.8 7.8.1 7.8.2 7.8.3

Calibration of the gas monitor (Artema AION) .............................................7-27 Required tools and testing equipment .....................................................7-27 Calibration Gas measurement.................................................................7-28 Flow Sensitivity Calibration Servomex O2-Sensor...................................7-31

Figures Page Figure 1: Test setup for calibration of fresh gas flow monitor .............................................7-6 Figure 2: Test setup for calibration of airway pressure monitor ..........................................7-7 Figure 3: Setup of pressure reducer gas box Rev001 ........................................................7-9 Figure 4: O2 Gas box Rev001 inlet pressure ......................................................................7-9 Figure 5: O2 Gas box Rev001 inlet pressure ......................................................................7-9 Figure 6: Setup of pressure reducer gas box Rev002 ......................................................7-10 Figure 7: O2 Gas box Rev003 inlet pressure ....................................................................7-10 Figure 8: O2 Gas box Rev003 inlet pressure ....................................................................7-10 Figure 9: N2O Gas box Rev002 inlet pressure: (Type of gas)...........................................7-11 Figure 10: N2O Gas box Rev002 inlet pressure (valves) ..................................................7-11 Figure 11: O2 Gas box Rev003 inlet pressure ..................................................................7-11 Figure 12: Setup of pressure reducer gas box Rev003 ....................................................7-12 Figure 13: O2 Gas box Rev003 inlet pressure ..................................................................7-12 Figure 14: O2 Gas box Rev003 inlet pressure ..................................................................7-12 Figure 15: Position of pressure reducer for slide valve pilot pressure ..............................7-13 Figure 16: Adjustment pilot pressure slide valves.............................................................7-13 Figure 17: Position of pressure reducer for surplus diaphragm pilot pressure..................7-14 Figure 18: Adjustment pilot pressure surplus diaphragm..................................................7-14 Figure 19: Hardware calibration pressure monitor ............................................................7-15 Figure 20: Hardware calibration of drive gas inlet pressure..............................................7-16 Heinen + Löwenstein®, Service Manual leon(plus) Rev. 2.04

7-1

Chapter 7: Calibration

Figure 21: Hardware calibration of fresh gas flow monitor................................................7-18 Figure 22: Zero point calibration Flow Sensor ..................................................................7-20 Figure 23: System calibration Flow Sensor ......................................................................7-21 Figure 24: Calibration of sensor........................................................................................7-22 Figure 25: Calibration of the fresh gas O2 measurement cell............................................7-23 Figure 26: Pressure sensor calibration (0 cmH2O) ...........................................................7-24 Figure 27: Pressure sensor calibration (60 cmH2O) .........................................................7-25 Figure 28: Test setup up gas measurement accuracy ......................................................7-28 Figure 29: Service menu gas span calibration..................................................................7-29 Figure 30: Service menu Zero Ref. Valve-Test.................................................................7-30 Figure 31: Test setup flow calibration Servomex O2 Sensor.............................................7-31 Figure 32: Service menu calibration flow sensitivity Servomex O2 Sensor.......................7-32

Tables Page Table 1: Overview calibration hardware..............................................................................7-4 Table 2: Overview calibration software ...............................................................................7-4 Table 3: Overview calibration optional components ...........................................................7-4 Table 4: Calibration of drive gas inlet pressure.................................................................7-17

7-2

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Chapter 7: Calibration

7.1

Intervals

Every 12 months (maintenance): • • •

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

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

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

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

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

Heinen + Löwenstein®, Service Manual leon(plus) Rev. 2.04

7-3

Chapter 7: Calibration

7.2

Differences leon / leonplus

The following tables contains the calibration procedures in line with the maintenance for the units leon und leonplus.

Calibration procedures Hardware Fresh gas blender inlet pressures (7.6.1 - 7.6.3) Pilot pressure slide valves (7.6.4) Pilot pressure surplus diaphragm (7.6.5) Hardware calibration for airway pressure measurement (7.6.6) Hardware calibration of inlet drive gas generator (7.6.7) Hardware calibration of fresh gas flow monitor (7.6.8)

leon X X X X -

leonplus X X X X X X

leon

leonplus

X

X

leon X X

leonplus X 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) Table 2: Overview calibration software

Calibration optional components (if existant) Calibration of FiO2 measurement cell (7.7.2) Calibration of the gas monitor (Artema AION) (7.8) Table 3: Overview calibration optional components

Explanation: X

=

Procedure required

-

=

Procedure not practicable

7-4

Heinen + Löwenstein®, Service Manual leon(plus) Rev. 2.04

Chapter 7: Calibration

7.3

Required tools and testing equipment

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

•

Flow analyzer (e.g. PF-300)

•

Test tube system (3 tubes, 22mm M connector)

•

Pressure measurement adapter with pressure sample line

•

Set of screwdrivers (flat head, Philips head)

•

Socket wrench 5.5 mm

•

Allen key (2.5mm)

•

Trimmer utensils

•

Calibration gas (bottle) 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 •

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

Heinen + Löwenstein®, Service Manual leon(plus) Rev. 2.04

7-5

Chapter 7: Calibration

7.4

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

7-6

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Chapter 7: Calibration

7.5

Test setup for pressure monitor/calibration

Use the following test set, 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 measurement Figure 2: Test setup for calibration of airway pressure monitor

Procedure for devices with external fresh gas outlet: (also applicable for devices with O2 auxiliary flow meter, without external fresh gas outlet)

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

Close all the fresh gas valves (press button A). Open the swing arm with the cartridge.

C

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.

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7-7

Chapter 7: Calibration

7.6

Hardware calibration

The hardware calibration of the leon(plus) 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 leon(plus), hardware calibration is extremely important.

CAUTION! To ensure the measured values during calibration are absolutely accurate, please note the following points:

7-8

•

Carry out a light 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).

•

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 swing arm if necessary).

Heinen + Löwenstein®, Service Manual leon(plus) Rev. 2.04

Chapter 7: Calibration

7.6.1

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 3: 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 4: 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 5: O2 Gas box Rev001 inlet pressure

Overview: Inlet pressure O2 AIR

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

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

Heinen + Löwenstein®, Service Manual leon(plus) Rev. 2.04

7-9

Chapter 7: Calibration

7.6.2

Fresh gas blender inlet pressure (O2/AIR/N2O) – Gas box Rev002

CAUTION! 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 reducer needs 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 6: 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 7: 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 8: O2 Gas box Rev003 inlet pressure

Important note! Make a note of the measured flow value when adjusting the AIR pressure. 7-10

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Chapter 7: 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 9: 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 10: N2O Gas box Rev002 inlet pressure (valves)

Now switch over to N2O as the carrier gas (Button A, Figure 9). 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 11: O2 Gas box Rev003 inlet pressure

Overview: Inlet pressure O2 AIR N2O

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

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

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Chapter 7: Calibration

7.6.3

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). IMPORTANT:

O2 pressure reducer

AIR pressure reducer

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

Figure 12: 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 13: 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 14: O2 Gas box Rev003 inlet pressure

Overview: Inlet pressure O2 AIR

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

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

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Chapter 7: Calibration

7.6.4

Pilot pressure slide valves

To ensure the correct switching of the slide valves in the cartridge 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 connectors block. A

Figure 15: 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

Figure 16: Adjustment pilot pressure slide valves

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Chapter 7: Calibration

7.6.5

Pilot pressure surplus diaphragm

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

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

A

Figure 17: Position of pressure reducer for surplus diaphragm pilot pressure

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

Measure the pressure on the connection mandrel (B) for the „Surplus 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 “surplus diaphragm” several times.

Inlet: Low-Pressure

Flow-Analyzer

Pressure measurement

B Figure 18: Adjustment pilot pressure surplus diaphragm

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Chapter 7: Calibration

7.6.6

Hardware calibration for airway pressure measurement

The airway pressure monitor 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.

Calibration Procedure: Remove the water trap from the gas monitor, if there is one (IMPORTANT!) For voltage calibration, connect multimeter between pin 1 (mass) and pin 2 of the pin strip. Zero: 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 2

Pin 1 zero

Gain: At 60 cmH2O on DRM3, set a voltage of 2.48 V using the "gain" trimmer. (corresponds to DRM 3 ADC = 508) Alternative: At 100 cmH2O on DRM3, set a voltage of 4 V using the "gain" trimmer. (corresponds to DRM 3 ADC = 819)

Pressure sensor (DRM3) Airway pressure (Paw)

Overview: Pressure 0 cmH2O 60 cmH2O 100 cmH2O

DRM 3 ADC 41 ± 1 508 ± 2 819 ± 3

Voltage 200 ± 5 mV 2.48 ± 0.01 V 4.0 ± 0.02 V

DRM 3 ADC

Figure 19: Hardware calibration pressure monitor

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Chapter 7: Calibration

7.6.7

Hardware calibration of inlet drive gas generator

The drive gas for the bellows is metered independently of the supply pressure of the leon(plus). The pressure sensor (DRM1/2) is located on the drive gas generator board. The calibration is done at 4 bar drive gas preliminary 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. Calibration Procedure: Connect multimeter between pin 1 (ground) and pin 3 of the pin contact strip. Zero: No adjustment necessary. Gain:

gain

Pin 3

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

Pin 1

Pressure sensor (DRM1/2) Drive gas inlet pressure

Overview:

Central gas supply inlet pressures

Pressure 4 bar

DRM 1/2 ADC 512 ± 5*

*or use the table on the following page

DRM 1/2 ADC

Figure 20: Hardware calibration of drive gas inlet pressure

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Voltage 2.5 ± 0.05 V

Chapter 7: Calibration

Calibration of drive gas inlet pressure 4bar If it is not possible to calibrate the drive gas inlet pressure, 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 20: 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 DRM1/2 382 393 404 415 426 436 447 458 469 480 490 501 512 523 534 544 555 566 577 588 598 609 620 631 642 652 663 674 685 696 706 717 728

Table 4: Calibration of drive gas inlet pressure

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Chapter 7: Calibration

7.6.8

Hardware calibration of fresh gas flow monitor

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

Calibration Procedure: Switch to the external fresh gas outlet. Connect the flow analyzer to the fresh gas outlet. 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, and set the measured value on leonplus.

Figure 21: Hardware calibration of fresh gas flow monitor

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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 anesthetic gas mixer.

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

CAUTION! It is necessary to calibrate the software after each software installation. 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 22: 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 cartridge swung open. 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 22) the date of the last calibration is now displayed under "Zero Point".

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Chapter 7: Calibration

System calibration: 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 23: 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 23) 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 leon(plus) has an O2 measurement cell for measuring the inspiratory O2 content (FiO2). This measurement cell, if there is one, requires calibration.

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

2

3 Figure 24: 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 24) the date of the last calibration is displayed under „FiO2“ .

4

Dialogs

Defective O2 measurement cells often 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.

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Chapter 7: Calibration

7.7.3

Calibration of the fresh gas O2 measurement cell

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 25: 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 25) the date of the last fresh gas O2 calibration is displayed under "Fresh gas O2".

4

Dialogs

Defective O2 measurement cells often 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

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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 sensors 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 26: 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 swing 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 26) 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, page 7-7).

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

2

3 Figure 27: 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 27) the date of the last 60 cm H2O calibration is displayed under "Pressure"

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Chapter 7: Calibration

7.8

Calibration of the gas monitor (Artema AION)

The gas monitor needs to be calibrated when the gases are outside of allowable tolerances. The values need to be checked during annual maintenance.

CAUTION! Perform a calibration of the gas monitor only if the accuracy test failed and the readings are out of tolerance.

7.8.1

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

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 •

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

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Chapter 7: Calibration

7.8.2

Calibration Gas measurement

Preliminary steps/test setup: 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. Do not also use silicon tubes for the test equipment setup because ist can falsifies the measured values.

Rotameter (Flow-Analyzer)

>0 ml /min

T-Fitting

Water trap

Calibration gas Figure 28: Test setup up gas measurement accuracy

CAUTION! Make sure that excess pressure does not build up at the supply to the water trap. For this reason, never connect the calibration gas bottle directly to the water trap! Excess pressure can can severely damage or destroy the sidestream monitor.

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Chapter 7: Calibration

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

Figure 29: Service menu gas span calibration

•

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.

•

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”.

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Chapter 7: Calibration

Zero Ref. Valve Test: Use the same test equipment setup as used for the gas span calibration Procedure: Chose „Yearly Maintenance“ option „Zero Ref. Valve-Test► Calibrate“

Figure 30: 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.

•

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 “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 “Zero Ref. Valve-Test”.

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Chapter 7: Calibration

7.8.3

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“:

leon(plus) EXT FG / O2 INSP

BAG EXP

min. 30 cm

A

Open the freshgas valve 0 (A) to create a oxygen flow.

Figure 31: Test setup flow calibration Servomex O2 Sensor

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Chapter 7: Calibration

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

A

Figure 32: 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 “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 “Sensor sensitivity”.

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