Saturn Evo Operators Manual 4th Edition 2008 PDF [PDF]

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SATURN EVO OPERATOR’S MANUAL 4th edition JUNE 2008

SATURN EVO ANAESTHESIA SYSTEM OPERATOR’S MANUAL

0499 4th edition June 2008

MEDEC BENELUX NV

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronically, mechanically, by photocopying, recording or otherwise, without the prior written permission of Medec Benelux NV.

Medec Benelux NV reserves the right to change specifications without prior notification. Careful attention has been paid to the compilation of this publication.

Medec Benelux NV Lion D’Orweg 19 9300 Aalst Belgium Telephone : (32) 53 / 70.35.44 Fax : (32) 53 / 70.35.33 Website : www.medecbenelux.be E-mail : [email protected]

4th edition June 2008

Table of Contents 1. Saturn Evo system overview 1.1 General 1.2 User responsibility 1.3 Main components

1 1 1

2. Saturn Evo anaesthesia configuration 2.1 Gas supply & trolley connections 2.2 Mechanical functions

2 3 5

1. SATURN EVO SYSTEM OVERVIEW

1.1 GENERAL This manual is intended to provide authorized personnel with following information: • • •

how to operate the Saturnus anaesthesia system the operating principles of the system maintenance checks that should be performed

Personnel should make themselves familiar with the contents of this manual before using the anaesthesia system. 1.2 USER RESPONSIBILITY The equipment described in this manual has been built to conform with the specifications and operating instructions stated in this manual. To ensure proper and safe operation of the equipment, it must be checked and serviced to at least the minimum standards laid out in this manual. The equipment must be repaired and serviced only in accordance with written instructions issued by Medec Benelux NV and must not be altered or modified in any way without written approval of Medec Benelux NV. The user of this equipment shall have the responsibility for any malfunction which results from improper use, maintenance, repair, damage or alteration by anyone other than Medec Benelux NV or its appointed agents. 1.3 MAIN COMPONENTS An overview of the system’s components is shown on the following page. The system’s main components are: • • • •

Saturn Evo trolley Saturn Evo electronic ventilator – operator’s manual Saturn Evo CO2 absorber system – operator’s manual Saturn Evo ORC rotameter

Each of these components is described in a separate section of this manual.

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2. SATURN EVO ANAESTHESIA CONFIGURATION

Monitor shelf

Vaporizers - three stations

Rotameter with oxygen ratio controller

Patient arm and autoclavable circuit

Electronic ventilator Writing shelf

Absorber system Drawer unit

suction jar

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2.1 GAS SUPPLY & TROLLEY CONNECTIONS Numbers in text refer to figure 1 and figure 2. •

NIST connectors - see Saturn Evo electronic ventilator manual.

•

Cylinder holders (fig. 1) The trolley is provided with 3 cylinder holders (4) on the back of the trolley. Cylinders and regulators are optional items.

•

Fresh gas outlet - absorber (fig. 2) When the front/absorber knob on the ventilator is switched to absorber, the fresh gas flow is directed via the fresh gas outlet connector (2) on the trolley to the absorber system, into the circle system.

•

Suction (fig. 2) The collection jar is connected to the suction input connector (1) and operated via the ventilator front panel.

•

Oxygen measurement (fig. 2) The oxygen measurement set is connected to the input connector (3) on the trolley panel.

FIG 1

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FIG 2

Schematic diagram See operator’s manual Saturn Evo ventilator

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2.2 MECHANICAL FUNCTIONS Numbers in the text refer to figure 3 •

Top tray Instruments, monitoring etc. may be put on the top tray (1).

•

Writing shelf (2) Push to open

•

Light (3) Built-in light. 3 positions + off.

•

Drawers (4) The drawers may be used to store instruments, etc.

•

Braking system (5) The braking system to block the wheels is activated by pressing pedal 1 and pedal 2 located on the front wheels. FIG 3

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SATURN EVO ELECTRONIC VENTILATOR OPERATOR’S MANUAL

0499 4th edition June 2008

MEDEC BENELUX NV

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronically, mechanically, by photocopying, recording or otherwise, without the prior written permission of Medec Benelux NV.

Medec Benelux NV reserves the right to change specifications without prior notification. Careful attention has been paid to the compilation of this publication.

Medec Benelux NV Lion D’Orweg 19 9300 Aalst Belgium Telephone : (32) 53 / 70.35.44 Fax : (32) 53 / 70.35.33 Website : www.medecbenelux.be E-mail : [email protected]

4th edition June 2008

Table of Contents 1. General information 1.1 General 1.2 User responsibility 2. System overview 2.1 Front view 2.2 Side view 2.3 Back view 2.4 Schematic diagram of gas supply 2.5 Pneumatic connections 2.6 Front 2.7 Electrical connections

1 1 1 2 3 4 5 6 7 9 10

3. Operation 11 3.1 Operator interface 11 3.2 Switch on the ventilator 12 3.3 The display screen 13 3.4 Operating instructions 20 3.4.1 Preparations before use 20 3.4.2 Changing button parameters 20 3.4.3 Standby mode 21 3.4.4 Spontaneous / manual ventilation mode (MAN) 21 3.4.5 Controlled mandatory ventilation mode (CMV) 22 3.4.6 Pressure controlled ventilation mode (PCV) 22 3.4.7 Synchronized mandatory ventilation mode (SIMV) 23 3.4.8 Tidal volume (VOLUME) (CMV /SIMV mode) 24 3.4.9 Peak pressure (PEAK P.) (PCV mode) 24 3.4.10 Frequency (FREQUENCY) (CMV / SIMV / PCV mode) 24 3.4.11 Inspiration / expiration ratio (I/E ratio) (CMV / SIMV / PCV mode) 24 3.4.12 Inspiratoire pause (INSP. PAUZE) (CMV / SIMV mode) 24 3.4.13 Positive end expiration pressure (PEEP) (CMV / SIMV /PCV mode)25 3.4.14 Trigger (SIMV / PCV mode) 25 3.4.15 Sigh (CMV/ SIMV mode) 25 3.5 Oxygen measurement 26 3.5.1 Principle of operation 26 3.5.2 Operation 26 3.5.3 Set-up the O2 measurement 27 3.5.4 O2 calibration 29 3.6 Alarms, warnings and indicators 30 3.6.1 Lower limit pressure alarm (CMV/SIMV/ PCV mode) 31 3.6.2 Apnea alarm (Man/Spont mode) 31 3.6.3 Upper limit pressure alarm (CMV / SIMV and Man/Spont mode) 31 3.6.4 Switching between the different ventilation modes 32 3.6.5 Warning window 33 3.7 Performing a leaktest 36 3.7.1 Entering the leaktest 36 3.7.2 Performing the leaktest 37

3.7.3 Leaving the leaktest menu 3.8 The setup menu 3.8.1 Entering the setup menu 3.8.2 The setup menu 3.9 Battery backup

38 39 39 39 42

4. Cleaning and disinfecting 4.1 Ventilator housing 4.2 Patient breathing circuit

43 43 43

5. Maintenance, malfunction and troubleshooting 5.1 Maintenance 5.2 Malfunction - error codes 5.3 Troubleshooting 5.4 Fuse replacement

45 45 46 48 49

6. Specifications 6.1 General 6.2 Ratings

50 50 50

1. GENERAL INFORMATION

1.1 GENERAL This manual is intended to provide authorized personnel with following information: • • •

how to operate the Saturn Evo ventilator the operating principles of the system maintenance checks that should be performed

Personnel should make themselves familiar with the contents of this manual before using the anesthesia system. 1.2 USER RESPONSIBILITY The equipment described in this manual has been built to conform with the specifications and operating instructions stated in this manual. To ensure proper and safe operation of the equipment, it must be checked and serviced to at least the minimum standards laid out in this manual. The equipment must be repaired and serviced only in accordance with written instructions issued by Medec Benelux NV and must not be altered or modified in any way without written approval of Medec Benelux NV. The user of this equipment shall have the responsibility for any malfunction which results from improper use, maintenance, repair, damage or alteration by anyone other than Medec Benelux NV or its appointed agents.

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2. SYSTEM OVERVIEW

The Saturn Evo combines some never seen abilities, high technological research and a high level of security. Clear monitoring gives you full control at a single glance. Our well-studied platform is easy to handle and gives you many exceptional features. The platform is based on the well-known horizontal bag-in-bottle system. The Saturn Evo is an anesthesia ventilator that can handle spontaneous breathing as well. The system incorporates a semi-closed breathing circuit, to which a fresh gas flow is continuously directed. The patient inspires and expires either in the hand balloon (in spontaneous/manual mode) or in the bag (in CMV,SIMV or PCV mode). CO2 accumulation is prevented by means of an absorber. This manual will describe all control buttons and functions of the electronic ventilator. Both the alarm system and the cleaning procedures will be attended to as well.

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2.1 FRONT VIEW

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2.2 SIDE VIEW

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2.3 BACK VIEW

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2.4 SCHEMATIC DIAGRAM OF GAS SUPPLY

Oxygen, nitrous oxide and air from the wall supply flows through the rotameter and vaporizer-section to the selected fresh gas outlet (absorber or front outlet). Via a bypass, oxygen can also flow directly to the fresh gas outlet. Air is used as pneumatic supply to the ventilator. If no wall supply is available, oxygen and nitrous oxide can be supplied by high-pressure cylinders on the back of the trolley. Saturn Evo ventilator 4th edition – June 2008

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2.5 PNEUMATIC CONNECTIONS

6

5

1

2

3

4

7

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1. O2 NIST connection: two O2 NIST connectors for wall and/or for cylinder supply. 2. N2O NIST connection: two N2O NIST connectors for wall and/or cylinder supply. 3. Air NIST connection: air NIST connection for wall or cylinder supply. 4. Vacuum NIST connection. 5. Air, N2O and O2 output: for connection with rotameter. 6. Fresh gas input: delivered by rotameter. 7. Patient Evacuation. 8. Connection for GASOVAC. 9. Suction jar connection. 10. Fresh gas output: to absorber.

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2.6 FRONT 1

2

3

8

7 4

5

6

1. O2 input pressure indicator. 2. N2O input pressure indicator. 3. Air input pressure indicator. 4. Fresh gas front outlet: for connection with a mask. 5. Fresh gas absorber-front selection knob: select absorber to connect the fresh gas flow to the absorber. Select front to use the front outlet as fresh gas output.

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6. O2 flush button: bypasses the rotameter and vaporizer and directs a flow of 35 l/min O2 directly to the selected fresh gas output. There is a detection in CMV&SIMV when an oxygen flush is generated to prevent high pressure if the upper limit was set to high. The Max pressure allowed during an O2 flush is last peak pressure + 20 hPa / 20 mbar and this level must be below upper limit setting (last pip +20 is below upper limit setting). When the upper limit alarm is lower ,the upper limit alarm level is used. The min level is 30 hPa / 30 mbar if upper limit is higher. When the upper limit alarm level is lower then the calculated safety, the upper limit alarm level has priority. 7. Suction On/Off knob: for use with suction jar. 8. Vacuum pressure indicator. 2.7 ELECTRICAL CONNECTIONS 2

3

1

4 1. The mains power inlet: connect the power cord with the mains power inlet. Turn switch ON. The ventilator is working on mains supply and the battery is charging. The green mains indicator at the front will be lit. The battery will not be charged with the main switch in the OFF position. The ventilator will work on battery and the green mains indicator is off. 2. +12V DC output for lighting: power for top shelf lighting. 3. Mains outlet: outlet for connection with 4 mains outlets located at upper back panel. 4. O2 sensor input: connection for O2 measurement. Saturn Evo ventilator 4th edition – June 2008

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3. OPERATION

3.1 OPERATOR INTERFACE 5

6

4

1 3

2

1 1. Buttons: to select and change ventilator settings. 2. Control knob: for changing the settings. 3. Silent button: all the alarms are mute for one minute when this button is pressed. 4. ON / OFF button: press this button for at least 1 second to switch the ventilator on/off. 5. Display screen: displays measured data and settings. 6. Mains indicator: this green indicator lights up when the ventilator is connected to the mains power and the power switch on the back panel is switched on. Saturn Evo ventilator 4th edition – June 2008

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3.2 SWITCH ON THE VENTILATOR As soon as the power cord is connected to mains supply and the main switch is turned on, the mains indicator will be illuminated. button for at least 1 second turns on the ventilator. Pushing the A short beep indicates that the ventilator is turned on. The display remains dark for a few seconds during start-up. During initialization, the display will show a logo and all main functions - including the microprocessor functions, external component tests, etc. - will be tested. After succeeding the self-test, the ventilator enters standby mode. When a failure is detected, the display screen will show an error code and a short description of the failure. Refer to chapter ‘TROUBLESHOOTING’ for more information about the error codes.

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3.3 THE DISPLAY SCREEN •

The standby window

After turning the ventilator on, it will always start up in the standby window.

1

2

3

Standby window

1. Setup: the setup button in the standby window is used to access the setup menu. 2. Leaktest: the leaktest button in the standby window is used to access the leak test menu. 3. Mode: with the mode button, you can switch between the different ventilator modes: CMV,SIMV, PCV, Man/Spont and standby mode. Press the mode button, change the value by rotating the control knob and execute by pressing the control knob. You can cancel by pressing the mode button once again.

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•

The CMV window

The settings of the ventilator are presented on a number of large screen push buttons. 13

12

11

10

9

1 8 2 3

4

CMV window 5

6

7

1. Limit pressure: sets upper limit and lower limit pressure. 2. PEEP: the PEEP can be adjusted by using this button. The PEEP range is between 0 - 20 hPa / 0 – 20 mbar. 3. Inspiratoire pause: the INSP. PAUSE can be changed in steps of 5% from 0% to 50%. 4. Mode: with the mode button, you can change between CMV,PCV,SIMV, Man/Spont and standby mode. 5. Tidal volume: the tidal volume can be set from 10 ml to 1600 ml. 6. Frequency: the frequency range can be set in the range from 4 - 80 breaths per minute. Limitations on the frequency depending on the I/E ratio setting. I/E ratio 1:1 1:1.5 1:2 1:3 1:4 1:5 1:6 2:1 3:1 4:1 Saturn Evo ventilator 4th edition – June 2008

Frequency range 4 – 80 4 – 80 4 – 80 4 – 40 4 – 50 4 – 60 4 – 70 4 – 80 4 – 80 4 – 80 14

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7. I/E ratio: this button sets the I/E ratio. The possible values are 1:1, 1:1.5, 1:2, 1:3, 1:4, 1:5,1:6, 2:1, 3:1, 4:1. Limitations on the I/E ratio depending on the frequency setting. Frequency range 4 - 40 41 – 50 51 – 60 61 – 70 71 – 80

I/E setting 1:1, 1:1.5, 1:2, 1:3, 1:4, 1:5,1:6, 2:1, 3:1, 4:1 1:1, 1:1.5, 1:2, 1:3, 1:4, 1:5, 2:1, 3:1, 4:1 1:1, 1:1.5, 1:2, 1:3, 1:4, 2:1, 3:1, 4:1 1:1, 1:1.5, 1:2, 1:3, 2:1, 3:1, 4:1 1:1, 1:1.5, 1:2, 2:1, 3:1, 4:1

8. Measurement window: this window contains the measured values from the last inspiration / expiration cycle and the barograph. These values are updated at the end of each expiration. The measured values are: expired tidal volume, minute volume (MIN.VOL.), peak inspiration pressure (PIP), plateau pressure (PLATEAU), positive end expiration pressure (PEEP), mean pressure (MEAN) and compliance (COMPL.). The barograph is updated continuously. 9. Silent indicator: the silent symbol is flashing after the silent button is pressed, and no apnea alarm is active. A down counter (starting from 60 seconds) gives an indication how long the Alarm disable function will be active. 10. Time: actual time is displayed over here. 11. Date: actual date is displayed over here. 12. Mains / battery indicator: when working on mains supply, the following . When working on batteries, a battery symbol symbol is shown indicates the battery status . 13. Barograph: the barograph indicates airway pressure in the range from -10 hPa / -10mbar to 100 hPa / 100mbar.

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•

The SIMV window

1

SIMV window 1.Trigger: sets the trigger on/off and adjusts the trigger level –2 to –20 hPa -2 to -20mbar. Trigger is a trigger below Peep and Max adjusted trigger level that can be set is equal to peep setting. All the other settings and buttons are similar as described in CMV mode.

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•

The PCV window

PCV window

1

1. Peak pressure: sets the peak pressure. All the other settings and buttons are similar as described in CMV and SIMV mode.

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•

The Man/Spont window

Man/Spont window In MAN mode, the upper limit pressure alarm can be set. Apnea alarm can set ON or OFF.

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•

The graph window

Select the graph window by rotating the control knob. Note:

It is not possible to change to the graph window when alarms or warnings are still active.

1 8

2

7

3 4

6

Graph window 5 1. Pressure scale: changes the graph pressure scale between 25 hPa/25 mbar, 50 hPa/50 mbar and 100 hPa/100 mbar. 2. Time scale: changes the graph time scale between 5 sec, 10 sec and 20 sec. 3. Freeze / Run: freeze the graph by pressing this button. Pressing this button a second time, will set the graph in run mode. 4. Sigh: sets sigh on/off. Can only be set in CMV or SIMV mode. 5. Mode indicator: indicates the actual mode. 6. Measurement window: contains the measured values from the last inspiration/expiration cycle. 7. Graph: airway pressure (hPa/mbar) versus time (seconds) is displayed. 8. Slider: the slider will synchronize with the start of a new inspiration. The slider waits at the start of the graph until a new inspiration takes place. In MAN mode, the slider is continuously running independent of the inspiration / expiration cycle.

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3.4 OPERATING INSTRUCTIONS 3.4.1 Preparations before use Before use, make the following connections: -

check supply of air, oxygen and nitrous oxide.

-

check the main supply indicator.

-

connect patient circuit through absorber system.

-

connect manual system with the hand balloon and patient system.

-

connect the patient tubing to absorber outlets.

-

switch the ventilator on by pressing the

-

check the battery backup by pulling the mains plug (optional).

-

perform a leak test (optional).

button for at least 1 second.

After these preparations the ventilator is ready for use. 3.4.2 Changing button parameters A button press inverts the selected setting. Example of a button with one parameter:

Example of a button with two or more parameters:

Rotating the control knob changes the value of the setting. Pushing the control knob will save the changed value. Pressing the selected button again will cancel the changed parameter value and the value restores to the previous value.

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Note:

When no button is pressed or when the control knob is rotated within 10 seconds, the selected setting will automatically restore to the previous value. 3.4.3 Standby mode The ventilator will always start in "standby mode". From the standby window you can perform following actions: -

Open the setup menu. Open the leaktest menu. Start the ventilator in manual mode. Start the ventilator in CMV mode. Start the ventilator in PCV mode. Start the ventilator in SIMV mode.

3.4.4 Spontaneous / manual ventilation mode (MAN) The spontaneous / manual mode (MAN mode) allows spontaneous breathing of the patient and manually controlled ventilation with a hand balloon. The ventilator will be in this mode if: -

it is not switched on. it is switched on and in the standby window. it is switched on and in MAN mode. in case of a technical failure.

In MAN mode, the Saturn Evo can even be used without electrical and/or compressed air connections. When no electrical connection is available, the readouts of the measured values, alarms and warnings will of course not be displayed.

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3.4.5 Controlled mandatory ventilation mode (CMV) If the ventilator is activated, it can be switched to the controlled mandatory ventilation mode (CMV mode) with the use of the mode button. The following screen pops up:

Set up the parameters for use during CMV mode. Push the control knob to confirm and switch over to CMV mode or rotate selector knob to select cancel. 3.4.6 Pressure controlled ventilation mode (PCV) Switch the ventilator to the pressure controlled ventilation mode (PCV mode) with the use of the mode button. The following screen pops up:

Push the control knob to confirm and switch over to PCV mode or rotate selector knob to select cancel.

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3.4.7 Synchronized intermitted mandatory ventilation mode (SIMV) If the ventilator is activated, it can be switched to the Synchronized intermitted mandatory ventilation mode (SIMV mode) with the use of the mode button. The following screen pops up:

Set up the parameters for use during SIMV mode. Push the control knob to confirm and switch over to SIMV mode or rotate selector knob to select cancel. In CMV / PCV/ SIMV mode, several controls are available. If a control is changed, the new value will be used after a complete expiration cycle. The lower limit pressure and upper limit pressure values will be used immediately. When switching over from MAN mode to CMV / PCV/ SIMV mode, the Saturn Evo will start with an inspiration, when patient pressure is lower than 2mbar. The ventilator will wait to go to CMV / PCV/ SIMV mode due the following reasons: -

low oxygen input pressure. low nitrous oxide input pressure. low air input pressure. fresh gas volume higher than set volume.

The MODE text will be blinking during waiting changing mode from MAN to CMV/PCV/SIMV or CMV/PCV/SIMV to MAN.

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3.4.8 Tidal volume (VOLUME) (CMV & SIMV mode) The tidal volume is set in ml. It may take a few breathing cycles before the set volume is reached. The Saturn Evo electronics will automatically correct any deviation to the preset volume. This correction is being calculated by a microprocessor, based on a number of parameters (compliance, leakage, fresh gas flow, etc.). This setting is applicable in CMV & SIMV mode. 3.4.9 Peak pressure (PEAK P.) (PCV mode) Set up the peak pressure in mbar with this button. The ventilator will regulate the flow during inspiration to reach the peak pressure as fast as possible and keep it at this level for the whole duration of inspiration. The peak pressure can be set from 5 - 60 hPa. The peak pressure is visualized on the barograph (upper dotted line). This setting is applicable in PCV mode only. 3.4.10 Frequency (FREQUENCY) (CMV / PCV/ SIMV mode) The breathing frequency can be set from 4 - 80 breaths per minute. This setting is applicable in CMV , PCV and SIMV mode. 3.4.11 Inspiration / expiration ratio (I/E ratio) (CMV / PCV / SIMV mode) The I/E ratio can be set 1:1, 1:1.5 , 1:2 , 1:3, 1:4 , 1:5 , 1:6 , 2:1 ,3:1 and 4:1. This value reflects the relation between inspiration and expiration and is therefore applicable in CMV , PCV and SIMVmode. For example: the I/E ratio is equal to 1:2, i.e. the duration of expiration is twice as long as the duration of inspiration. 3.4.12 Inspiratoire pause (INSP. PAUSE) (CMV & SIMV mode) The insp. pause can be set 0 - 50% in steps of 5%. This value is equal to the pause used during inspiration expressed by percents of the total inspiration time. This setting is applicable in CMV and SIMV mode only.

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3.4.13 Positive end expiration pressure (PEEP) (CMV / PCV / SIMV mode) The PEEP is the Postive End Expiration Pressure. The PEEP range is 0 - 20 mbar. Note:

When setting a (higher) PEEP, one has to take into consideration that "building" a PEEP requires extra volume. This extra volume will be delivered to the system through the fresh gas flow. Because the Saturn Evo is suitable for very low fresh gas flows, the PEEP may be built very slowly.

3.4.14 Trigger (SIMV / PCV mode) Trigger below peep. With this button the trigger function can be enabled or disabled. The trigger value can be set from - 2 to - 20 mbar. The Max trigger level that can be set is equal to the peep setting. Press the trigger button once; rotate control knob and press control knob to enable/disable the trigger function. Press the trigger button twice, rotate control knob and press control knob to change trigger value.

A trigger event is visualized in the trigger button and on the airway pressure graph with the symbol .

Note:

You must select a PEEP of minimum 2 mbar to use the trigger function. If you select a PEEP lower than 2 mbar, the trigger function is automatically switched off.

3.4.15 Sigh (CMV / SIMV mode) The sigh button is shown when the graph window is selected . Press the sigh button once to set sigh on. A sigh is generated every 64 breaths. During a sigh, a volume of approximately 1,5 x tidal volume is delivered to the patient. Press the sigh button once again for sigh off. This setting is applicable in CMV and SIMV mode. Note:

The sigh function is standard off after switching the ventilator on.

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3.5 OXYGEN MEASUREMENT 3.5.1 Principle of operation The oxygen measurement is done with an O2 fuel cell. The oxygen sensor function is similar to a typical battery. The sensor consists of an anode, a cathode and a unique weak acid electrolyte. Oxygen molecules diffuse through a non-porous membrane and are reduced at the cathode. The current generated between the electrodes is directly proportional to the concentration of oxygen in the measured gas. Just like a battery, the output voltage of the sensor drops at the end of its operating life and the sensor will fail to measure oxygen concentrations. 3.5.2 Operation Oxygen measurement is available in manual mode, CMV ,PCV and SIMV mode. 1

2

3

O2 measurement in CMV mode

1. O2 concentration: the actual measured O2 concentration expressed in % O2. 2. Low O2 alarm: lower O2 alarm can be set in the range from 18% to 99% O2. If the O2 concentration is lower than the set value, the lower O2 alarm is activated, which will be visual and audible. 3. High O2 alarm: high O2 alarm can be set in the range from 19% to 99% O2 and OFF. If the O2 concentration exceeds the upper O2 alarm, the O2 high alarm is activated, which will be visual and audible.

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To change the lower O2 alarm, make sure there is no other setting selected and press the control knob once.

The lower O2 alarm will be activated. Change the value by rotating the control knob. Press the control knob once to confirm the new value. The high O2 alarm will not be selected. Change the high O2 alarm by rotating the control knob. Press the control knob once to confirm the high alarm. An alarm indicator is drawn on the screen after an alarm occurred. alarm indicator

Press the control knob once to reset the alarm indicators. 3.5.3 Set-up the O2 measurement Set the ventilator to standby mode and press the setup button to enter the setup menu. Always disconnect the patient before entering the setup menu. After entering the setup menu, swap to the SETUP O2 window by pressing the button.

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1 4 2

5

O2 setup menu

3

1. O2 alarm: sets up the low and high O2 alarm for use after turning the ventilator on. 2. Calibration buttons: use these buttons to perform a 21% or 100% O2 calibration. 3. O2 sensor on / off: you can disable O2 measurement if no O2 sensor is available. 4. O2 concentration: the actual O2 concentration is represented to check if a calibration is necessary. 5. Status line: the status of the O2 module is shown over here. The following error codes are available: O2 module is not working properly. Please contact your local service engineer. O2 module is working properly. See section "Calibration" later described in this manual. See section "Calibration" later described in this manual.

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3.5.4 O2 calibration Oxygen measurement is done by means of a "fuel cell" type sensor. These sensors do have a certain lifecycle expressed by "O2 % hours". Note:

The lifecycle of the sensor is strongly reduced by high O2 concentrations.

Perform a 21% O2 calibration if the O2 sensor doesn’t show 21.0% when the sensor is kept in ambient air. Perform a calibration each time the sensor is replaced. You can perform two types of calibration: • 1-points calibration „ Put the O2 sensor in ambient air and wait for a stable reading. „ Press the

button.

„ The message "O2 calibration successful" is shown after a successful calibration. The display reading will be equal to 21.0%. „ The message "O2 calibration failed" is shown when the calibration fails. The O2 sensor must be kept in ambient air. Also check the electrical connections of the sensor. Replace the sensor if the problem still remains. • 2-points calibration „ After a successful 21% O2 calibration, put the O2 sensor in pure oxygen and wait for a stable O2 reading. „ Push the

button.

„ The message "O2 calibration successful" is shown after a successful calibration. The display reading will be equal to 100.0%. „ The message "O2 calibration failed" is shown when the calibration fails. The O2 sensor must kept in pure oxygen. Also check the electrical connections of the sensor. Replace the sensor if the problem still remains. Note:

100% O2 calibration is not necessary. You can reduce the sensor linearity error with a 2-points calibration.

Press the button to store the calibration factors. Press the button to ignore the new calibration factor. The old calibration factors are restored.

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3.6 ALARMS, WARNINGS AND INDICATORS 1

11 10

12 9

2

8

7

6 3

3

5

4

1. Upper limit pressure alarm indicator: text is flashing when an upper limit pressure alarm is active. 2. Lower limit pressure alarm indicator: text is flashing when a lower limit pressure alarm is active. 3. Trigger status: symbol is active during a triggered inspiration/expiration cycle. 4. MODE indicator: indicator is blinking during switching between the different ventilator modes. 5. Warning and alarm window: window contains all kind of information about the status of the ventilator. 6. Sigh status: symbol is shown when sigh is active during the complete inspiration/expiration cycle. 7. Silence indicator: indicates that alarm sounds are suppressed by pressing the silent button and a down counter (seconds starting at 60) is visual to give the user an idea how long the alarm is suppressed. 8. High oxygen alarm 9. Low oxygen alarm 10. Low battery indicator: the battery symbol is blinking when the battery is almost empty. A plug is drawn when working on mains supply.

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11. Limit pressure alarm indicators: these indicators are blinking when a limit pressure alarm is active or has happened. Cleared by pressing the pressure limit button. 12. O2 SENSOR alarm : This indicator is blinking when the O2 sensor is disconnected. 3.6.1 Lower limit pressure alarm (CMV / PCV / SIMV mode) The lower limit pressure alarm is functional in CMV,PCV and SIMV mode. The lower limit pressure alarm is visualized digitally, in the barograph and on the airway pressure graph. The alarm will sound and the indicator will start blinking if the airway pressure does not cross the preset level during the inspiration or when during expiration the airway pressure stays below preset level. The alarm will automatically be disabled as soon as the patient pressure exceeds the lower limit pressure during inspiration. button. The silence You can silence the alarm for 1 minute by pressing the indicator will then start blinking ,the down counter is set to 60.

3.6.2 Apnea alarm (Man/Spont mode) The apnea alarm is functional in the Man/Spont mode. If there is no inspiration/expiration cycle detected within 20 seconds, the alarm will sound (continuous beep) and a warning screen is displayed:

You can silence the alarm for 1 minute by pressing the button. The silence indicator will then start blinking ,the down counter is set to 60. The Apnea alarm can be switched OFF but when the ventilator is switched OFF and ON the apnea alarm is set ON.

3.6.3 Upper limit pressure alarm (CMV,SIMV and Man/Spont mode) The upper limit pressure alarm is functional in CMV,SIMVand Man/Spont mode. When, during a full respiratory cycle, the pressure exceeds the upper pressure limit, the alarm will be active. The indicator will start blinking and an audible alarm will sound. The ventilator will automatically evacuate gas to prevent unlimited pressure rise if working in CMV or SIMV mode.

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The ventilator will not evacuate gas during an upper limit pressure alarm in Man/Spont mode. You have to check the setting of the safety valve on the handset with the upper limit pressure value. button. The silence You can silence the alarm for 1 minute by pressing the indicator will then start blinking ,the down counter is set to 60. The alarm will automatically be disabled as soon as the patient pressure no longer exceeds the upper limit pressure. Note:

At the time of an upper limit pressure alarm, the ventilator may not be able to deliver the preset tidal volume. This is because the safety valve is opened and gas evacuation is taking place.

3.6.4 Switching between the different ventilation modes When changing to another ventilator mode, the ventilator will first end his inspiration / expiration cycle and then switch over to the new selected mode. While waiting to switch over, the mode text is blinking. When switching to CMV, PCV or SIMV mode, several warning windows can be displayed and the ventilator is waiting to go to the new selected mode due the following reasons: -

Patient pressure more than 2 mbar Low oxygen input pressure Low nitrous oxide input pressure Low air input pressure Fresh gas volume higher than set volume

Look at the warning windows section (5.6.4) to solve these problems. If working in CMV / PCV / SIMV mode, the ventilator can be forced to MAN mode because a malfunction is detected. The following warning window is shown and the mode text is blinking:

One or more warning windows display the reason why the ventilator is forced to MAN mode. These warning windows are cleared when the ventilator is switched to standby or MAN mode.

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3.6.5 Warning window The warning windows are projected above the read-outs of the measured values. Only the expired tidal volume is visible. At the same time, a warning window is drawn. A warning window indicates a malfunction, an alarm, a wrong setting, etc. of the ventilator. It is a helpful item for the operator using the ventilator in a correct way. When several warning windows have to be displayed, it will swap every 3 seconds to another warning window. The display will automatically switch over from the graph window to the main window when warnings or alarms are active. An overview of the possible warnings is given in the following table: Warning window

Mode

MAN

MAN CMV PCV SIMV

CMV PCV SIMV

MAN CMV PCV SIMV CMV PCV SIMV

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Description Apnea alarm occurred. A continuous beep is active during an apnea alarm.

The air input pressure is too low or the ventilator fresh gas front output is selected. When working in CMV / PCV/SIMV mode, the ventilator will be forced to MAN mode. An audible alarm is active that can be suppressed by the silence button. Check absorber-front knob, air input connection, connection tube and wall supply. This warning is displayed when switching to CMV / PCV / SIMV mode. The airway pressure cannot be decreased. In order to prevent a double inspiration, the ventilator will not switch over until pressure is less than 2 mbar within 10sec. The fresh gas transducer needs to be calibrated. Contact an authorized service engineer. Detailed maintenance procedures are covered in the technical manual. The fresh gas flow is too large for proper working of the ventilator. Decrease fresh gas flow by adjusting the rotameter.

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Warning window

Mode

Description

CMV PCV SIMV

Unable to deliver set tidal volume. The internal balloon is completely empty after inspiration. Decrease frequency and/or tidal volume setting or increase fresh gas flow.

MAN CMV PCV SIMV

MAN CMV PCV SIMV

CMV PCV SIMV

CMV PCV SIMV

CMV PCV SIMV

MAN

Saturn Evo ventilator 4th edition – June 2008

The oxygen input pressure is too low. When working in CMV / PCV / SIMV mode, the ventilator will be forced to MAN mode. An audible alarm is active that can be suppressed by the silence button. Check oxygen input connection, connection tube and wall supply. The nitrous oxide input pressure is too low. When working in CMV / PCV / SIMV mode, the ventilator will be forced to MAN mode. An audible alarm is active that can be suppressed by the silence button. Check nitrous oxide input connection, connection tube and wall supply. If working in CMV / PCV / SIMV mode, the ventilator can be forced to MAN mode because a malfunction is detected. One or more warning windows display the reason why the ventilator is forced to MAN mode. A major leak is detected or the patient is disconnected. Check patient, patient circuit and/or perform a leaktest. An audible alarm is active that can be suppressed by the silent button. Check for proper connection of the patient breathing circuit to the ventilator bottle. Perform a leaktest. Contact an authorized service engineer if the warning remains active. Detailed maintenance procedures are covered in the technical manual. The airway pressure is higher than the upper limit pressure and the alarm is activated. Adjust the safety valve on the handset, or check upper limit pressure value to prevent this alarm.

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Warning window

Mode CMV PCV SIMV

CMV PCV SIMV

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Description Ventilator is not able to work with the actual settings. Adjust ventilator settings.

Maximum tank volume reached. Ventilator is unable to deliver set volume. Decrease frequency or tidal volume setting.

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3.7 PERFORMING A LEAKTEST 3.7.1 Entering the leaktest menu Set the ventilator to standby mode and press the leaktest button. Always disconnect the patient before entering the leaktest menu. Note:

It is not possible to enter the leaktest menu when the airway pressure is greater than 2 hpa/2 mbar. Disconnect patient so that pressure can decrease to 0 hpa/0 mbar.

The leaktest menu is drawn in accordance with the next drawing. 6 1 2

5

3

4

1. Patient circuit + internal bag button: press this button to select the patient breathing circuit and the internal balloon leaktest. 2. Patient circuit + handset button: press this button to select the patient breathing circuit and the external handset. 3. EXIT: press this button to leave the leaktest menu. 4. PEEP valve leakage detected: this message appears when the PEEP valve leakage test fails. 5. Information window: follow these instructions to perform a leaktest. 6. Barograph: indicates airway pressure.

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3.7.2 Performing the leaktest You can perform a leaktest on: -

the patient breathing circuit and the external handset. the patient breathing circuit and the internal balloon.

To perform a leaktest on the patient breathing circuit and the external handset, proceed as follows: -

Press button. Make all the connections in the patient breathing unit; see the operating instructions of the CO2 absorber. Close safety valve on handset. Close / disconnect sample tube of gas monitor (optional). Close the output of the Y-piece. Set a fresh gas flow. Let the airway pressure increase to 30 hPa. Close the fresh gas flow. The time in which the pressure decreases to 20 hPa must be 15 seconds or longer.

If the leak test is not within the specifications, check all connections in the patient breathing circuit. If no leaks can be found, contact your service department. After successful performing the previously described leaktest, you can perform a leaktest on the patient breathing circuit and the internal balloon. Proceed as follows: -

button. Press Close the output of the Y-piece. Set a fresh gas flow. Let the airway pressure increase to 30 hPa. Close the fresh gas flow. The time in which the pressure decreases to 20 hPa must be 15 seconds or longer.

If the leak test is not within the specifications, check all connections in the patient breathing circuit. Also check the internal balloon for leaks. If no leaks can be found, contact your service department.

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When pressing the button to perform a leaktest, at the same time the PEEP valve located in the patient breathing unit is filled once with a pressure of ±100 mbar. The pressure in the PEEP valve will be monitored during 15 seconds. If a pressure drop is detected within these 15 seconds, the message "PEEP valve leakage detected" will be displayed:

To repeat the PEEP valve test, press the press.

button followed by a

button

To determine either the PEEP leakage is intern in the ventilator or extern in the patient breathing unit, remove the patient circuit from bottle and close the PEEP output with finger in accordance with next drawing.

Keep your finger on the PEEP output and repeat the PEEP valve test. If the PEEP valve test succeeds, the problem is located in the patient breathing unit, otherwise the problem is probably intern in the ventilator. Please contact your service department. 3.7.3 Leaving the leaktest menu Leave the leaktest menu by pressing the exit button. The ventilator will return to standby mode.

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3.8 THE SETUP MENU 3.8.1 Entering the setup menu Set the ventilator to standby mode and press the setup button to enter the setup menu. Always disconnect the patient before entering the setup menu. 3.8.2 The setup menu You can swap between the different setup menus by pressing the •

button.

Setup window 1

Setup window 1 is equal to the CMV window. The parameters for use during CMV mode after turning the ventilator on can be set here. button to switch to the next setup window. Press the •

Setup window 2

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Setup window 2 is equal to the PCV window. The parameters for use during PCV mode after turning the ventilator on can be set here. Press the button to switch to the next setup window. •

Setup window 3

Setup window is equal to the SIMV window. The parameters for use during SIMV mode after turning the ventilator on can be set here. Press the button to switch to the next setup window. •

Setup window 4

See paragraph ‘3.5.3 Set up the O2 measurement’ for a description of O2 setup menu. Press the button to switch to the next setup window.

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•

Setup window 4 8 7 6 5

1

2

3

4

1. Window select: press this button to switch between the different setup windows. 2. Language select: set up the language to be used by the ventilator. You can chose between two different languages. 3. Cancel: press this button to cancel the changes made in the setup menu. 4. Save: store the changes made in the setup menu to the memory. 5. Sound volume: set up the speaker sound volume in the range 1-5. 6. Date: set up the day, month, century and year. 7. Time: set up hours and minutes. 8. Ventilator information window: the Saturn Evo serial number (S/N), the software revision numbers (S/R) and the total working time in hours of the ventilator are displayed. Note:

The 'cancel' and 'save' button have no effect on date and time. A change of date and/or time will be stored immediately into the memory.

Rotating the encoder knob will change the position of the selection box and adjust a selected value by pressing the control knob. The value is inverted and a rotation of the control knob will adjust the value. Confirm the adjusted value by pressing the control knob.

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3.9 BATTERY BACKUP The Saturn Evo ventilator is fitted with a battery backup system that allows at least 1 hour of operation if no mains supply is available. If the mains indicator is off and the battery symbol is drawn on the display, the battery is in use. If the battery is almost exhausted, the low battery symbol is blinking and every minute, an audible sound is generated. Reconnect the mains supply or prepare for manual controlled ventilation. A continuous beep will sound for 30 seconds after the ventilator shuts off. The internal battery is automatically charged when the ventilator is connected to the mains power. The charging of the battery is electronically controlled to assure optimum battery operating conditions. The battery does not require maintenance under normal circumstances. Note:

To check whether the battery backup is functioning properly, disconnect the mains supply by pulling the mains plug. The ventilator should be able to operate normally in all modes of operation.

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4. CLEANING AND DISINFECTING

4.1 VENTILATOR HOUSING The front panel of the Saturn Evo is made of a high-grade polycarbonate foil. All common household-cleaning products can be used without harm to the front panel surface. Aggressive products may affect the foil. The ventilator housing may be cleaned with a moisturized cloth. Caution:

Use cleaning solution sparingly. It may flow into the ventilator and cause internal damage.

4.2 PATIENT BREATHING CIRCUIT The patient breathing unit can easily be removed for disinfection by pulling the handle (figure 4.1). The metal part can be steam-sterilized (max. 138 °C) or gas-sterilized. When putting back the patient breathing circuit, it is recommended to manually guide the bag to prevent it from damage (figure 4.2). Note:

The patient breathing circuit may never be immersed in liquid. This may result in obstruction of valves and tubes, causing the patient breathing circuit to malfunction. It is of utmost importance to use undamaged bags, recommended by Medec Benelux NV. When in doubt, always replace the bag by a new one.

It is recommended to have further maintenance performed by an authorized service engineer. Detailed maintenance procedures are covered in the technical manual.

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Figure 4.1 – Removing the patient breathing circuit

Figure 4.2 – Putting back the patient breathing circuit

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5. MAINTENANCE, MALFUNCTION AND TROUBLESHOOTING 5.1 MAINTENANCE To assure trouble-free operation of the ventilator, the following maintenance activities should be carried out: •

Each time the ventilator is used -

•

Perform a leaktest. Check the battery backup system. Check the absorber sodalime; (re-)fill if necessary. Check the absorber water trap.

Every 6 months -

Preventive maintenance.

This service must be carried out by an authorized service engineer. -

Note:

Check the ventilator calibration settings and recalibrate if necessary. Visual inspection of the ventilator internal and external connections, electronic boards and valves, etc. Detailed maintenance procedures are covered in the technical manual.

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5.2 MALFUNCTION – ERROR CODES If a pneumatic or electronic failure occurs during use or during power-on selftest, an audible alarm will sound. The display will show an error code and the ventilator will automatically switch over to spont/man mode. During the alarm, even if electronics are turned off, the patient can be ventilated by means of the hand balloon. This type of failure will require the attention of an authorized service engineer, who can easily test the basic functions by means of the incorporated software. A description of the possible error codes is given in the following table: Error code 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35

Error description Display board - Internal program memory error Display board - Internal SRAM error Display board - Internal timer error Display board - Internal EEPROM error Display board - Internal watchdog error Reserved Reserved Reserved Reserved Reserved Display board - External flash error Display board - External SRAM error Display board - External display driver error Reserved Reserved Reserved Reserved Reserved Board communication failure Reserved Keyboard controller - Internal program memory error Keyboard controller - Internal SRAM error Keyboard controller - Internal timer error Keyboard or control knob blocked Keyboard controller - Internal watchdog error Keyboard controller - Communication timeout Keyboard controller not detected Board communication error - 25 ms timeout Board communication error - Parity error start-up Board communication error - Parity error start-receive byte Board communication error - Receive string length error Board communication error - Eot counter out of range Board communication error - Target slave not ready Board communication error - Transmit string wrong Reserved

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Error code 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 … 99

Error description Reserved Reserved Reserved Reserved Reserved Pneumatic board global error Reserved Reserved Pneumatic board – Not able to start A/D converter Pneumatic board – A/D converter busy time-out Pneumatic board – A/D readings equal to $FFF Pneumatic board – A/D readings equal to $000 Pneumatic board – Internal EEPROM memory error Pneumatic board – 12V input voltage too low Pneumatic board – 12V valves enable circuit error Pneumatic board – 12V valves disable circuit error Pneumatic board – Not able to fill tank Pneumatic board – Not able to stop tank filling Pneumatic board – Tank low flow valve close time Pneumatic board – Tank high flow valve close time Pneumatic board – End exp. pressure to high Pneumatic board – PIP press. higher than upp.lim. Pneumatic board – Not able to lower tank pressure Reserved

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5.3 TROUBLESHOOTING If the ventilator is not working properly as described in this manual, try to resolve the problem by means of the following table. If the malfunction cannot be corrected using the suggestions in the table below, an authorized service engineer must perform further troubleshooting. Symptom The ventilator is off and there is no response when pressing the ON/OFF button The ventilator shuts off after a short period of time

Bad and/or unstable operation in CMV/SIMV or PCV mode Can not swap to the graph window by rotating the control knob

Possible causes Battery completely exhausted Blown fuses

Replace fuses at the back of Battery at end of life time the trolley

Calibration factors not up-to-date Alarms are still active Warnings are displayed on the screen Control knob failure

The ventilator is working in MAN mode, there is no patient connected and the airway pressure is not zero

An obstruction in the patient breathing circuit Calibration factors not up-to-date

Upper limit pressure alarm An obstruction in the patient breathing circuit

Major leakage not able to deliver set volume

No freshgas flow. Tubes disconnected Leakage in circuit Zero level TRX1 negative Broken bottle venting valve

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Action Check power cord and power switch at the back of the trolley

48

Replace battery (performed by an authorized service engineer) Contact authorized service engineer Change the settings so that no alarms are active Resolve warnings Check possible control knob failure by changing a setting Check for obstruction in the patient breathing circuit If the problem can’t be resolved, contact authorized service engineer Check upper limit pressure setting Check for obstructions in the patient breathing unit Perform both leaktests. Disconnect tubes from patient breathing unit and check level patient pressure Must be zero. If the problem can’t be resolved, contact authorized service engineer Operator’s manual

Symptom Can not enter leaktest menu

Possible causes Airway pressure more than 2 mbar

Action Disconnect patient and try again

5.4 FUSE REPLACEMENT Replace the power mains fuses by means of the following instructions:

Note:

-

Turn off the Saturn Evo and disconnect the power cord from the mains supply.

-

Insert a screwdriver in the small AC receptacle and pull out the fuse holder block.

-

Replace the blown fuses and place the fuse holder block back into the AC receptacle.

-

Connect the power cord back to the mains supply. Always replace the blown fuses with the same type and ratings.

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6. SPECIFICATIONS 6.1 GENERAL Operating principle:

Bag-in-bottle

Volume adjustment:

Semi-closed loop control

Flow pattern:

Decelerating (CMV) Decelerating (SIMV) Decelerating (PCV)

Alarms:

Lower limit pressure / apnea Upper limit pressure Low battery Malfunction Low air input pressure Low oxygen input pressure Low nitrous oxide input pressure PEEP valve leakage detect Major leak or patient disconnected

Warnings:

Several warnings to indicate incorrect use of the ventilator by the operator.

System screen: Multi-language:

EL display Multiple languages available (on request)

6.2 RATINGS Main supply: Power consumption: IEC 601 class and type:

100 - 240V, 50 - 60Hz < 100VA Class I, type B

Battery type: Battery run time: Battery life time:

Sealed lead-acid battery minimal 1 hour when fully charged Approx. 3 years at 20°C

Pneumatic supply: Pressure: Connection: Gas evacuation: O2 flush: External fresh gas outlet:

compressed air or oxygen 3 - 8 bar According to NIST Max. – 0,5 bar 35 liter/minute front output and absorber output (selectable)

Ventilation modes: Tidal volume (CMV): Peak pressure (PCV): Rate: PEEP: Inspiratoire pause: I/E ratio: Trigger: Sigh: Airway pressure: Lower limit pressure: Upper limit pressure:

CMV, PCV,SIMV and Man/Spont mode 10 – 1600 ml 5 – 60 hPa / 5 – 60 mbar 4 – 80 bpm 0 – 20 hPa / 0 – 20 mbar 0 – 50 % 1:1,1:1.5, 1:2, 1:3, 1:4, 1:5,1:6,2:1,3:1,4:1. OFF; -2 to –20 hPa below PEEP approximately 1,5 x tidal volume (CMV/SIMV) -10 – 100 hPA / -10 – 100 mbar 2 – 94 hPa / 2 – 94 mbar 7 – 99 hPa / 7 – 99 mbar

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