manual de entrenamiento ventilador de anestesia blease 8500

8500 Ventilator Training Manual

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Blease 8500

Anaesthesia Ventilator

Training Manual

Part Number: 129TM000 Issue 3

0120


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Read this manual before servicing the 8500 Ventilator


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Contents

1. Mode Descriptions for the 8500

2. Test Procedures Adjustment and Calibration Document 129AC000

Checklist and Calibration Record Document 129TC000

Final Test Procedure Document 129TP000

3. Circuit Diagrams Interconnection Diagrams

8500 Electrical Interconnection 6500/8500 Pneumatic system Diagram

Display Blease Display Interface 10100190

Pressure Interface Pressure Interface 10110088

BAV Controller BAV Controller Type 2 Alarms 10110077 BAV Controller Type 2 Analogue 10110077 BAV Controller Type 2 Connect 10110077 BAV Controller Type 2 CPU 1010077 BAV Controller Type 2 I/O Circuits 10110077 BAV Controller Type 2 Memory 10110077 BAV Controller Type 2 PWM 10110077

Power Supply BAV Power Supply 101CD076


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The Blease 8500 ventilator must only be serviced by Qualified Service Personnel.

The contents of this manual are not binding. If any significant difference is found between the product and this manual please contact Blease Medical Equipment Limited for further information. To ensure correct functioning, the equipment must be serviced at regular in-tervals.

Blease Medical Equipment Limited recommends that the machine should be serviced at intervals not exceeding three months. Qualified Service Personnel and genuine spare parts should be used for all servicing and repairs. Blease Medical Equipment Limited will not otherwise assume responsibility for the materials used, the work performed or any pos-sible consequences of the same.

In communication with Blease Medical Equipment Limited, quote the model and serial number of the equipment, with the approximate date of purchase. If the unit is being re-turned for repair, indicate the nature of the fault or the work you require to be carried out.

Contact: Blease Medical Equipment Limited Beech House Chiltern Court Asheridge Road Chesham Buckinghamshire HP5 2PX England Tel: +44 (0)1494 784422 Fax: +44 (0)1494 791497 www.blease.com [email protected]


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MODE Descriptions for the 8500s

PEEP

Control Panel

The Control panel has a permanent display of measured PEEP and a button to actuate the setting of the desired value.

The display box will have the heading PEEP and show the SET value.

The default is that PEEP will be at the minimum setting ie. the residual that is < 2 cmH2O caused by the bellows assembly. In this default condition or if the Set value is subse-quently set below 3 cmH2O the set value display will show as OFF.

The method of control is that the user will rotate the Trak Wheel until the desired display is highlighted, press the Trak Wheel and then increase the set value by rotating the Trak Wheel until the desired value is reached, this is then accepted by a further press of the Trak Wheel.

The range of set values will be 3 to 20 cmH2O. An alarm will be implemented to indicate to the user that the set value has not been maintained. The alarm will activate at 50 % of the set value.

The activation of a set value will be made by pressing the Trak Wheel. If this is not done no change will be made and the previous value will be reset after a time out period. This is to apply to all controls.

The implication of PEEP on other alarms is that the Pressure and cycle alarms will be PEEP referenced, the pressure Limit will be absolute. ie. Referenced to atmosphere

Control System

For the control system to effect PEEP two functions will need to be activated :-

1. During the expiration phase of the breathing cycle or continuously in Spontaneous mode the flow control valve will pass 10 LPM of diving gas.

2. A pulse width modulator will control the power to the coil of a PEEP valve. This valve is a voice coil actuator working as a variable spring applying a force to a disc that impinges on a seat. The implication being that the valve is closed until the gas pressure exceeds the actuator force.

The control processor will monitor the PEEP value and modify the PWM setting to main-tain the desired value.


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Future Improvements

In the 8500s ventilator there is a monitor that measures the fresh gas flow of the anaes-thetic machine. The 10 LPM gas flow from the Flow valves in 1 above is an arbitrary fig-ure that has been arrived at empirically. This flow can be reduced substantially at low fresh gas flow rates. It only requires high drive gas flows with high fresh gas flows to maintain PEEP. This could obviously save gas which would be helpful when using cylinders for sup-ply.

Volume Control ventilation (CMV)

Volume Control ventilation is a mechanical mode that delivers a tidal volume set by the user into the patient tubing. This delivered volume is to be independent of the compression losses in the absorber, bellows and associated tubing. It will also be independent of any small leaks that may be present. Fresh gas flowing into the breathing system will not cause a permanent change in the delivered volume. If a change in fresh gas flow rate oc-curs during ventilation the ventilator will re-adjust the delivered tidal volume to be correct within the next 4 breaths.

8500s Ventilator Fresh Gas and Compliance Compensation

Fresh Gas

Fresh gas flow adds to the delivered Tidal Volume during the inspiratory period. To com-pensate for this, a reduction in the delivered volume needs to be made. This reduction is :-

FG Flow rate ml / M x Insp Time (sec)

60

Take FG = 5 LPM TV 600 ml 10 BPM I:E 1:2.0

5000 x 2 seconds = 166 ml

60

New Effective TV is now 600 - 166 = 434 ml

Compliance

The effect of the gas being compressed in the dead space within the breathing system is to reduce the Volume (TV) that is delivered to the patient. In an ideal ventilator the Set TV would the volume of gas that is delivered to the patients lungs. This can only be partly achieved because the anatomy of the patient is unknown, what can be done is the set TV can be made to be accurately delivered from the catheter mount. Thus reducing set TV er-rors to a minimum.


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To calculate the effect of Breathing System compliance on the delivered TV it is necessary to measure what the capacity or compliance of the system is (Cs). This can only be done by some form of pre-use check procedure. In essence it is necessary to have the ability to first of all select Compliance Compensation from a menu. It is then necessary to lead the user through the process of measuring the dead space within the particular breathing sys-tem for that period of use. It is obvious that should the system be re-configured the test will need to be repeated.

A possible process is to allow the ventilator to prompt the user to :-

1. Reduce the FG flow to minimum (but Allow for it as above)

2. Occlude the catheter mount. This can be a 15 mm male taper on the gas machine.

3. The ventilator then delivers a breath to pressurize the system to 10 cmH2O.

4. The ventilator records the volume required to achieve this pressure and verifies that a leak is not present.

The dead space is now calculated as follows :-

Volume in ml = Dead space compliance Cs Pressure

This figure is stored until the ventilator is switched off or a re-test is asked for by the user.

The ventilator is then set to use on a patient and when the ventilation is stable measure the total compliance of system and patient Ct. An adjustment can the be made to the TV that will be increased to compensate for the lost volume due to compression within the breathing system. :-

Increase in TV = Set TV x 1 + Cs = new TV Ct - Cs

eg.

System test Measurement using 200 ml gave 25 cmH2O pressure rise.

80 ml = Cs = 8 10 cmH2O

Running the ventilator on a patient with a set 500 ml TV gave 20 cmH2O peak pressure .

500 ml = Ct = 25 20 cmH2O

So to calculate the TV increase :-

500 x 1 + 8 = 735 ml 25 - 8


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So 735 ml is the actual ventilator output into the breathing circuit to give 500 mL at the catheter mount.

This figure would have to be recalculated in the light of any fresh gas flow change as above but would just be a variation on the 735 ml figure.

Pressure Control ventilation (PCV)

Pressure control ventilation is a time cycled mode where the ventilator strives to produce the user set inspiration pressure for the inspiratory period. To accomplish this goal, the in-spiratory flow rate and pressure are set by the user. To do this, the control that is used for the Set TV function will be reasigned as I Flow and calibrated in LPM. The pressure Limit control becomes the Set Pressure control. This allows the user to define the deliv-ered wave form. The default pressure will be 30 cmH2O in both Adult and Paediatric modes.

Inspiratory Pause

A function that is Inspiratory Pause is to be implemented. This option will be available in volume and PCV mode such that a pause of 25% of the inspiratory time is used as a Pla-teau before starting the expiratory phase. This means the expiratory time is reduced by the plateau time. If at all possible the pause or plateau time should be made variable from 5 to 60 %. The x % should be displayed on the second row up of the display.

Sigh

Sigh is a function that can be selected in volume or Pressure ventilation the effect is that every 50 breaths the delivered breath is increased by 15 %. The selection of this function will be displayed as an extension to the main mode display under the bar graph.

Spontaneous or PSV

Spontaneous is a mode that is equivalent to the machine being in standby with all moni-toring enabled. This allows a patient to breath at their own rate and volume with the venti-lator being able to display the monitored parameters and actuate alarms. At this level the Breathing rate would be a monitored parameter, it should follow the same pattern as other features in that it will display the monitored value in large characters and show Pressure Support Ventilation PSV as the mode.

Pressure Support

When a patient is taking a Spontaneous Breath from an anaesthetic system the work of breathing is higher than normal. To overcome this it is desirable for the ventilator to be able to assist the spontaneous breath. The assistance is provided by the ventilator sens-ing the negative pressure caused by the Patient Attempt to breath and initiating flow from the ventilator. This flow is continued to the point where the breathing circuit pressure has reached a set value. ie. Pressure Support. To implement this action the user needs to be able to set first the trigger threshold in the range -1 to -10 cmH2O and secondly the Support Pressure 0 to 30 cmH2O both referenced to the PEEP level.


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It will also be necessary to define an inspiratory time in which the pressure support is deliv-ered. In this case the breathing rate and tidal volume are not relevant. The Inspiratory flow rate will be a fixed value of 40 LPM in Adult and 30 LPM in Paediatric.

The detection of a Patient Attempt will be carried out by the control system to aid the speed of support. A patient attempt will be indicated on screen by the negative excursion of the pressure wave form being green rather than blue for the positive phase.

SIMV

This mode is Synchronised Intermittent Mandatory Ventilation. This is an extension of the spontaneous mode in so far as the patient can take breaths on demand with pressure sup-port but some mandatory breaths are included. To achieve this it is necessary to set a tidal volume, a breathing rate and all of the features described above for pressure support. To simplify things a little the inspiratory flow rate can be assumed from the TV / Inspiratory Time set values.

The patient attempt or trigger signal will be used to synchronise the mandatory breaths to the patients breathing pattern and initiate the pressure supported spontaneous breaths. Thus allowing the patient to establish the breathing rate.

In this way a patient could be breathing at say 12 BPM with the settings such that 4 breaths of say 500 ml are mandatory and 8 breaths are taken spontaneously with pressure support of up to 30 cmH2O above the PEEP level.

The ventilator will monitor all of the breaths, display the parameters TV / BPM / I:E and in-dicate the patient attempt by showing negative excursions of the graph in RED. The set breathing rate and measured rate will be displayed, the Set Inspiratory time and I:E ratio will be displayed in the appropriate window.

A means of preventing hyperventilation will be implemented such that any change in breathing rate is only allowed to take place slowly.

The method of inflating the patient's lungs and the operation of the valves and the gas flows in the SIMV mode are the same as for the CMV mode.

The main difference between this mode and CMV is that a facility is provided for synchro-nising the mechanical breaths given by the ventilator to the patient's own respiratory ef-forts (spontaneous breaths).

If the patient fails to make any effort, then SIMV will default to ventilation functionally iden-tical to CMV at the set SIMV rate.

The routine within the ventilator that detects the Patient Trigger is used to detect the in-stant a patient starts to inhale and is thus ready for a synchronised breath to be given by the ventilator. Whether a breath is spontaneous or mandatory depends on where it occurs in the SIMV cycle.


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This can be explained as follows :-

1. The frequency control sets up an internal clock tick in the ventilator. The time be-tween clock ticks is the Set breathing period and is equal to a time in seconds of 60/frequency in BPM. ie. 4 BPM = 1 tick every 15 seconds

With no patient triggers detected, the ventilator will deliver a mechanical breath at the start of each respiratory period on the clock tick.

2. Preceding each clock tick is a time window in which the ventilator will be looking for a patient trigger. If a trigger occurs within the window the patient will be given a synchronised mechanical breath. If it occurs outside the window it will be a sponta-neous or Pressure Supported spontaneous breath depending on the ventilator set-ting.

In practical use of the SIMV mode, the ventilator should first be set at an adequate RATE, TIDAL VOLUME, I:E RATIO, PEEP and PRESSURE LIMIT for controlled ventilation, say 600 ml, 12 BPM and 1.5 secs for an adult patient. When patient trigger signals are being displayed regularly the mandatory rate can be reduced and the total breathing rate will be controlled by the patient. If this rate is inade-quate the the low MV or Rate alarm will be activated.


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Vol Rate I:E Press Limit Vol Alm

Lo / Hi

Press Alm

Lo / Hi

Adult 500 ml 12 1:2.0 50 4 / 10 4 / 55

Paed 150 ml 20 1:2.0 40 1 / 6 4 / 45

Vol Rate Insp TIME

Press Limit Vol Alm

Lo / Hi

Press Alm

Lo / Hi

Adult 500 ml 12 1.5 50 4 / 10 4 / 55

Paed 150 ml 20 1.5 40 1 / 6 4 / 45

Support Pressure

Rate Alm

Lo / Hi

Vol Alm

Lo / Hi

Press Alm

Lo / Hi

Adult 10 5 / 25 4 / 10 4 / 50

Paed 10 10 / 35 1 / 6 4 / 40

Mode Sigh Pause Press Supp PEEP MV Alm Rate Alm Press Alm

CMV

Spont

SIMV

PCV

CMV Defaults at start up

Matrix of Modes, Facilities and Alarms

Spontaneous Defaults at start up

SIMV Defaults at start up


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Insp Flow

Insp TIME

Support Pressure

Press Limit

Rate Alm

Lo / Hi

Vol Alm

Lo / Hi

Press Alm

Lo / Hi

Adult 30L 1.5 10 50 5 / 25 4 / 10 4 / 55

Paed 20L 1.5 10 40 10 / 35 1 / 6 4 / 45

Insp Flow

Ventilation Pressure

Rate Press Alm

Lo / Hi

Adult 30L 30 12 4 / 50

Paed 20L 20 20 4 / 40

Spontaneous with Pressure Support Defaults at start up

Pressure Control Ventilation Defaults at start up

Default for all Modes is PEEP off in PCV the maximum PEEP available will be limited to 6 cmH2O.

If PEEP is set, the default PEEP Alarm will be 50 % in the range 0 to 30 cmH2O

The Rate or BPM alarm is to be the set value 50 % or in SIMV mode Lo 10 hi 20 BPM.

Blease Test Procedure

Title: 8500 Adjustment & Calibration Document No:129AC000 Sheet 1 of 12

Issue 1 2 3 4 5 6

Change Note No n/a 3724 3829 3487 3866 3935

Originator JLB JLB JLB JLB JLB JLB

Checked DB RHC RHC RHC RHC

Date Nov 00 Dec 00 June 01 July 01 28/08/01

BLEASE QUALITY DOCUMENT

BQD 083.V2 25/5/94

1.0 OBJECTIVES To set up and calibrate the Blease 8500 Anaesthesia Ventilator. A final test (129TP000) must also be followed to obtain a set of calibration results. 2.0 SCOPE This test document is applied to new manufactured units before burn-in and after warm up, and/or when any repairs have been completed on the ventilator. This procedure is only valid for software versions 8.20 and 8.60 onwards. 3.0 OVERVIEW The following procedure describes the adjustments and checks necessary to calibrate the

ventilator and set all the pre-set controls to achieve the specified performance. Inability to make these adjustments, or failure to meet the specification, after these adjustments have been made, must be considered a fault.

The procedure given in section 4 is written so that minimum adjustment of controls and test

equipment is done between each test. This means that any particular test assumes all previous tests have been set up IN THE SEQUENCE STATED and passed. If this is not done, invalid results may be taken.

4.0 ADJUSTMENT AND CALIBRATION

All quoted test parameter values and tolerances are absolute with no allowance made for test equipment errors unless otherwise stated in the text. At appropriate points during this procedure the route card should be updated to reflect the key stages of calibration.


Title: 8500 Adjustment & Calibration Document No:129AC000 Sheet 2 of 12

BLEASE QUALITY DOCUMENT BQD 083.V2

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4.1 Test Apparatus 4.2 Initial Checks 4.3 Reference Voltage and Electrical Supplies 4.4 BAV Controller PCB

4.5 Display Interface PCB 4.6 Main Pneumatic Regulator Calibration

4.7 Calibration 4.8 Flow Control Set-up 4.9 Zero Offset Connection 4.10 Pressure Sensor Gain 4.11 Delivered TV Calibration 4.12 Hardware Pressure Overload Backup

4.13 Fresh Gas Flow Sensor Calibration 4.14 Saving Data and Printer Check

4.15 O2 Monitor Calibration 4.16 PEEP Calibration 4.17 Font Panel Calibration Adjustment 4.18 Parameter Checking 4.19 Assembly Completion and burn in

4.1 Test Apparatus Digital Voltmeter to measure the 4v reference supply. Timeter RT-200 Calibration Analyser with following options fitted: RT-201 Control

Module, RT-202 Press Module, RT-203 Flow Module, or another calibrated calibration analyser with the required functionality.

IBM PC (compatible) ANSI terminal emulator running on serial interface. 9600 baud, 8-data bits, 1 start bit and 1 stop bit.

Digital storage scope or chart recorder for monitoring drive gas flow waveform. Ventilator programming cable (12600015). For programming and diagnostics through

calibration port. Front Panel programming lead (12600016). Miscellaneous 17mm/22mm pneumatic tubes. O2 sensor simulator. (68A 68D)

20 1 L compliance. (C20), 5 0.25 L compliance

20 2 cmH2O /L/s resistance. (R20)

Title: 8500 Adjustment & Calibration Document No: 129AC000 Sheet 3 of 12


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4.2 Initial Checks

BAV Controller Board 10110077

Check all links are fitted correctly and securely.

JP2 link pins1&2

JP5 link pins 2&3

GND & AGND

No links to be fitted to JP1 & JP3

PSU Board 10100076

LK2 and LK3 on PSU board both have links fitted.

Display Interface Board 10100190

Ensure J15 has pins 3 & 4 linked

BAV Interface Board 10110075

4.3 Reference Voltage and Electrical Supplies

With nominal mains input applied, switch ventilator ON in standby mode.

Check the following voltages are correct before proceeding any further:

+24V Valve supply PSU TP6 = +25.0 2.0V

+25V unregulated PSU TP2 = +26.5 3.0V

Battery voltage PSU TP4 = +14.0 0.8V

A-5V analogue supply CPU-5VA = -4.20 0.3V

A+5V analogue supply CPU+5VA = +5.0 0.25V

ALM+5V alarm supply PSU TP7 = +5.0 0.25V

D+5V logic supply CPU 5V = +5.0 0.25V

+6V main supply PSU TP3 = +6.05 0.3V

+4VREF CPU 4V REF =+400060mV

4.4 BAV Controller PCB

To program the controller board connect the ventilator serial cable (12600015) between the calibration port connector on the back panel of the 8500 & a PC. Run the flash for front and back flash programming utility on the PC under windows & download the latest BAV.ABS opcode file.



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4.5 Display Interface PCB

First time program

Ensure that JP2 has a link fitted & JP1 has a link fitted between pins 1 & 2, prior to switch on.

Connect a serial cable (12600016) between J10 & a PC & run the Hitachi flash programming utility to load the H8/3048 microcontroller.

Select connect from the command menu, select BOOT mode and then OK to load the boot kernel.

Once the kernel has been downloaded select program for the command menu, the LOAD386.A20 absolute opcode file will be loaded.

Switch off 8500 remove the link on JP2 & move the link on JP1 to between pins 2 & 3.

Switch on the 8500 and run the flash for front and back program, select the A20 absolute opcode file, followed by open to download the file.

After the first time programming of the display interface board, ensure JP1 has a link between pins 2 & 3 and JP2 has no link fitted. Re-program

Connect the ventilator serial cable (12600015) between the calibration port connector on the back panel of the 8500 & a PC.

Run the flash for front and back utility under windows on the PC; select the A20 absolute opcode file, followed by open to download the file.

Enter the save menu on the 8500, select configuration, and enter the password PRAAA in the set-up menu.

Select re-program

4.6 Main Pneumatic Regulator Calibration

Remove the plug from the side of the pneumatic block and connect a pressure gauge to this port.

Select adult mode.

Using a DVM check that JP4 is open.

Connect gas supply.

Adjust the supply pressure to 35 psi/37 PSI Max

JP4 should now be closed.

The pressure switch should be adjusted so that as the supply gas is reduced, to between 35 & 37 PSI, the switch opens (on JP4).

Check the switch is reset by the time the supply pressure is raised in excess of 2 PSI beyond the stated alarm pressure.

Note: to run the Blease Medical Test I/O Diagnostics connect the ventilator serial cable between the recorder output connector on the back panel of the 8500 & a PC. Run Hyper Terminal on the PC using the stored 8500 HT settings file.



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Press CTRL+E on the PC followed by the up cursor key. Page through the diagnostics using the TAB key & scroll through using the UP/DOWN cursor keys.

Select Blow off valve ref. Pressure. Set a flow of 1 LPM, the flow rate can be adjusted using the Tidal Volume control.

Set main regulator output pressure = 34.0 0.5 PSI while ventilator is in standby mode.

Turn ventilator off and remove gas supply.

Remove pressure gauge and replace plug.

4.7 Calibration

Initial Calibration

Prior to calibrating the unit ensure that the switch, encoder and all the membrane key switches perform their expected functions.



On page 1 set gas to that specified by the model number, use right cursor, set gas convert to Norm.

Adjust RV2 on the Interface board for 50 mV +/-10 mV at FGZ test pin.

Select Patient airway pressure zero, to cal press Space Bar

Select Drive gas pressure zero, to cal press Space Bar

Select Flow gas pressure zero field

Adjust RV3 on the Interface board for a Flow gas pressure zero adjustment parameter of 600 5, press spacebar to update display. When achieved press Space Bar to save.

Select Patient Flow Pressure Zero.



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Adjust RV1 on the Interface board for 0V +/-10mV at PFZ test pin.

Press Space Bar to save.

Press Ctrl+U to save zeros.

Leak Test and Absorber Switching

Absorber switching

The function of this will have been checked during compliance compensation and the presence of an absorber will have been displayed.

Fresh gas leak test

Connect spirometry tubing 10110089 from TJ92 to the fresh gas connections on the rear of the ventilator. Each side of the circuit is checked by pressurising it to 80 mmHg and checking that the pressure is maintained.

Patient Flow transducer leak test

Connect spirometry tubing 10110089 from TJ92 to the patient connections on the rear of the ventilator. Each side of the circuit is checked by pressurising it to 80 mmHg and checking that the pressure is maintained.

Drive Flow Sensor Leak Test



Tee in to the drive gas outlet the pressure monitor and then block the flow sensor outlet. Select Blow off valve ref. pressure. With the flow sensor outlet blocked the internal pressure will build up until the Blow off valve operates.

Using an oscilloscope monitor the voltage at test point DF on the BAV Interface Board 10110099 this voltage will remain stable whilst the monitored pressure is stable if there are no leaks.

Once this test is complete restart the ventilator by pressing CTRL + E.

Run the ventilator for 3 hours on default settings, but with BPM set to 30.



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Fine calibration

Ensure that unit is in cal standby.

Note: to run the Blease Medical Test I/O Diagnostics connect the ventilator serial cable between the calibration port connector on the back panel of the 8500 & a PC. Run HyperTerminal on the PC using the stored 8500 settings file.


On page 1 set gas to that specified by the model number, use right cursor, set gas convert to Norm.

4.8 Flow Control Set-up

Connect Gas supply, Flow sensor, Fresh gas sensor and Mains power supply to the rear of the ventilator.

With no fresh gas supply and the flow sensor disconnected from the test lung, select the relevant fields; on the flowmeter, watch peak flow on constant not peak.

Select Flow valve just off ref. value.

Press space bar to start auto-find. A series of dots will appear in the value field. Once the lowest achievable flow has been discerned, the relevant value will replace the dots.

Select Min flow available (use right cursor) enter peak value from the monitor.

Select Flow valve on full ref. value.

Press space bar to start auto-find. A series of dots will appear in the value field. Once the highest achievable flow has been discerned, the relevant value will replace the dots.

Select Max flow available (use right cursor) enter peak value from the monitor.

Press Ctrl+U to save flows.

4.9 Zero Offset Correction

Select Patient airway pressure zero, to cal press Space Bar

Select Drive gas pressure zero, to cal press Space Bar

Select Flow gas pressure zero field

Adjust RV3 on the Interface board for a Flow gas pressure zero adjustment parameter of 600 5, press spacebar to update display. When achieved press Space Bar to save.

Select Patient Flow Pressure Zero.

Adjust RV1 on the Interface board for 0V +/-5mV at PFZ test pin.

Press Space Bar to save.

Select Fresh gas flow zero.

Adjust RV2 on the Interface board for -50mV +/-5mV at FGZ test pin.

Press Space Bar to save

Press Ctrl+U to save zeros.



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4.10 Pressure Sensor Gain

Wind both pots fully anti-clockwise on PEEP control board.

Select Blow off valve ref. Pressure. Set a flow of 1 LPM, the flow rate can be adjusted using the Tidal Volume control.

Tee in to the drive gas outlet the pressure monitor and then block the flow sensor outlet. With the flow sensor outlet blocked the internal pressure will build up until the Blow off valve operates. The pressure will then stabilise at this point, shown on the pressure monitor, this should be 75 3 cmH2O.

If the reading is other then 75 +/- 3 cmH2O then adjust the valve.

Select Patient airway pressure gain.

When measured patient airway pressure reaches set value press the Space bar to set gain value.

Select Drive gas pressure gain.

When measured patient airway pressure reaches set value press the Space bar to set gain value.

Press Ctrl+U to save values.

4.11 Delivered TV Calibration

With the flow sensor connected to the test lung (C20 compliance & R20 resistance) via the high flow port on the monitor, check the default values are set to; TV =500ml, rate = 12 BPM and Ratio 1:2.0.

Change mode from cal. standby to cal. mode. By pressing STBY/ON switch.

Select Flow gas pressure gain for a delivered output volume of 470ml TV. Adjust the tidal volume setting until 470ml is monitored, on the external monitor, not the 8500.

Press space bar to save.


Select patient flow inspired gain for a delivered output volume of 500ml TV. Adjust the tidal volume setting until 500ml is monitored, on the external monitor, not the 8500.

Press space bar to save.

DO NOT move the cursor from patient flow inspired gain until the displayed EtidalV value HAS GONE RED (on third breath) then returned to black.

Select patient flow expired gain, press space bar to set.


Change mode from cal. mode to cal. Standby, using STBY key.

4.12 Hardware Pressure Overload Backup

Put the ventilator in cal mode standby. All settings should be at default. Move the cursor to Sensor Calibration at the top of diagnostics page 1.

With a C5 compliance connected to the drive gas outlet. Put the ventilator into run mode and



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adjust flow for a peak pressure of 80 cmH2O. Wind R99 on the BAV board fully clockwise. Adjust R98 on the BAV board until pressure limiting is observed. This can be checked by observing that the can of Q1 goes high to low each time the limit is reached.

Once triggering has been achieved, decrease delivered volume to reduce the peak pressure to find the exact trigger point. The trigger point should be such that it will not have any effect on the ventilator functions. It should be set to greater than 80cmH2O.

4.13 Fresh Gas Flow Sensor Calibration

Ensure that the unit is standby.

Run the Blease Medical Test I/O Diagnostics, connect the ventilator serial cable between the calibration port connector on the back panel of the 8500 & a PC. Run HyperTerminal on the PC using the stored 8500 settings file. Press Ctrl+E to connection to 8500 then press up arrow to enter calibration page.

Ensuring that there is no fresh gas flowing, highlight the Fresh gas flow zero field and press spacebar to set value.

Set 10 LPM fresh gas flow, highlight Fresh gas flow gain (10 L/M) field and press spacebar to set value. Press Ctrl+U to save values.

Press Ctrl+E to exit calibration page.

Ensure that the unit is standby.

Press the memory button, then select configuration.

Select setup and enter password TECHY

Select fresh gas.

Ensure there is no flow through fresh gas flow sensor.

Press trakwheel to set 0 LPM

Set each flow rate as requested, press trakwheel to set.

Return to main screen.

4.14 Saving Data and Printer Check

Check all printer output parameters are set up and there are no warning messages. Label ventilator as calibrated.

Enter calibration date, on diagnostics page 2.

Enter the serial number & and the model number of diagnostics page 2.

Press Ctrl + U to save.

Press Ctrl + E to complete software calibration.

Run the Blease Medical Test I/O Diagnostics, connect the ventilator serial cable between the calibration port connector on the back panel of the 8500 & a PC. Run HyperTerminal on the PC using the stored 8500 settings file.

Choose printer output from the transfer menu. A print out of all parameters just set up is automatically obtained at switch on. Deselect printer output on the transfer menu, the stored information will now be printed.



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4.15 02 Monitor Calibration

Hardware Calibration

Short TP2 And TP3

Rotate VR2 fully anti clockwise when viewed from the back looking at the adjusting screw.

Adjust VR1 until just greater than 2.52V on TP1 and display turns to OFF.

Remove link and connect O2 sensor simulator to rear panel socket.

Set O2 sensor simulator to 100 then set VR2 fully clockwise and note that display reads over 100%. Also TP1 must be lower then 1.3V

Adjust VR2 until display reads approximately 1.28V on TP1.

Set O2 sensor simulator to 0. Check that no more than 2.49V on TP1. Check that display reads off when the sensor has been unplugged.

Software Calibration

Put 8500 into standby.

Press the menu button, and then select oxygen calibration.

Set the O2 sensor simulator to 100%.

Select the oxygen figure; use the trakwheel to change the number to 100. Push the Trak wheel to accept. Return to main screen.

Set O2 sensor simulator to 50 check display reads 50% 2%

Set O2 sensor simulator to 21 check display reads 21% 2%

Disconnect the O2 sensor simulator. Check the display shows OFF.

4.16 PEEP Calibration

Put unit into run mode.

Connect a scope probe to the connector PL8 pin 1 on the PSU board.

Run the 8500 with 500ml MV/TV, 12BPM, 1:2.0 Ratio.

Place a link on JP3 (2nd pair from the left) to disable feedback.

Adjust the PEEP setting from OFF to 3

Adjust VR1 on the PEEP Control board (part no.10101550) until the ripple is just visible below the 26V line.

Set the PEEP Control to 20 cm H2O.

Adjust VR2 to give an indicated 20 cmH2O of PEEP on the bar graph.

Recheck that when PEEP is turned off, no PEEP is shown on the bar graph.

Remove the link on JP3.

Check that when PEEP is set to 20 cmH2O the indicated PEEP level gradually increases over 4 or 5 breaths to the set value.



25/5/94

4. 17 Front Panel Calibration Adjustment

Set-up the vetilator in a full circuit including an absorber (See below). Run the ventilaor and compare the values displayed on the front panel of the ventilator with the values displayed by the calibration analyser.

20RResistor

20 LCompliance12600010

CalibrationAnalyser

Fresh gas is set for minimum required to maintain full bellows



25/5/94

4.18 Parameter checking

Check that the ventilator monitored Vte &Vti are within tolerance at the following settings

Set Tv 0.2, BPM 25, I:E 1:2 Measured Tv = Set Tv +/- 0.03



Set Tv 1.0, BPM 6, I:E 1:1.0 Measured Tv = Set Tv +/- 0.05

Also confirm that the ventilator monitored peak pressure = the externally monitored peak pressure +/- 2cmH2O.

4.19 Assembly Completion and burn in

At this point the case wrap should be put on the unit and the unit should be put on burn in for a further 24 hours before following final test procedure 129TP000.


10/5/96 Page 1 of 3

Checklist and Calibration Record for 8500 Anaesthesia Ventilator

Front Panel Part Numbers: Issue: 4 Software version:

BAV

Serial No: Document No: 129TC000 Supply Gas: Fresh Gas:

Works Order No: Date: Signature:

Ref Description Value Units Notes

5.2 Initial Inspect, mains in locked-plug type, finger proof exhaust, gas inlet, orientation

Gas Inlet Fixing =

Inlet (USA O2 green, USA Air yellow, UK 02 White, UK Air White/Black) Inlet ID =

Bellows =

P/F USA/UK USA/UK Ad/Paed

P/F Colour Ad/Paed

USA/UK

5.3 Leakage/Continuity mains supply volts Mains insulation (500v dc)

Earth Continuity Earth equipot Continuity ( 0.2R) Earth Leakage Normal ( 500mA)

Reverse ( 500mA) Supply (sfc) Normal ( 1000mA)

Reverse ( 1000mA)

------------- ------------- ------------- ------------- ------------- ------------- ------------- -------------

Vac Mohm Ohms Ohms mA mA mA mA

5.4 Fresh Gas Leak Test

Fresh gas alarm, Tv 0.5 Lpm

Fresh gas alarm, Tv 0.25 Lpm

P/F

P/F

P/F

P/F

P/F

P/F

5.5 Printer Out, Pressure high/low lim = 20 & prod model, Batch no., manu/cal date, soft vers, cal gas, option defaults, pressure zero 0.1, flow zero 0.5, Lims 1. 8500 pressure low alarm delay 20 seconds

P/F P/F

5.6 Battery Backup Vent/mains off, vent on mains fail Mains on, vent normal operation Mains off, battery charge off, mains fail on 1 min mains fail warning mains on, battery charge on, mains fail off

P/F P/F

5.7 Compliance Test

Absorber Switching connection

P/F

P/F

P/F

P/F

5.8 Mute Timeout Delay (seconds) 120

------------- -------------

----------- ----------- secs

5.9 Supply Gas Low alarm On (Standby) Low alarm Off (Standby)

------------- -------------

psi psi

Checked:-_______


10/5/96 Page 2 of 3

Vent Measured Ref

Description BPM TV(L) Ratio Del Freq (BPM) Del Ratio Del TV/L VTi VTe

5.10 Vent Control Functions 20C+20R Adult Mode Min Fresh Gas

6 6 10 20 20 20 40 60 90

1.0 1.0 1.0 0.6 0.4 0.2 0.1 0.2 0.1

1:1.0 1:Max 1:2.0 1:3.0 1:Min 1:2.0 1:2.0 1:1.0 1:2.0

------------- -------------

------------- ------------- -------------

1: 1: 1: ------------- 1: 1: ------------- 1: 1:

------------- ------------- -------------

----------- ----------- -----------

----------- ----------- -----------

Ref Operation\Description Value 2 Value 1 Units

5.11 Expired Volume + Alarms, 1000 ml / 10 BPM, 1:2.0 Ventilator Monitored MV (Value 2) & TV (Value 1)

MV/TV = 4L/200ml, Frq = 20 BPM Decrease gas, MV low alarm operation 6.0L for 30 seconds

------------- ------------- P/F P/F

VTi

VTe -------------

------------- L ------------- P/F P/F

5.12 Pat pressure + Alarms, 1000 ml / 12 BPM, 1:1.0 Delivered peak pressure (2)/vent monitored peak (1)

vent monitored mean Pressure high (2) and low (1) limit alarm settings

------------- -------------

------------- ------------- cm H2O cm H2O cm H2O

5.13 Adult 50 cm H2O pressure limit, 1200 ml, 10 BPM, 1:2.0 ------------- cm H2O

5.14 Apnoea Alarms Apnoea disconnection time (sens input), pressure limit = max

30

------------- ------------- -------------

------------- -------------

seconds

5.15 Vent Cycle Alarm , 20 BPM, disconnection time (sens input) ------------- seconds

5.16 Flow and waveform, TV 1L. 25 BPM, 1:2.0 Patient = C50, delivered TV

Paed bellows movement 50 ml bellows movement

200 ml bellows movement

------------- ------------- ------------- ------------- -------------

-------------

-------------

------------- L

-------------

ml ml

5.17 Paed 20 cm H2O pressure limit, /200 ml, 30 BPM, 1:2.0 Bellows pause position

Sensor disconnection

------------- -------------

-------------

cm H2O ml cm H2O

5.18 ASB Test

Trigger point 5, BPM 8500 (2), Timeter (1)

Trigger point 15 Breathing Stop

Alarm sound

Trigger point 5 Normal Running

Alarm silenced

-------------

-------------

-------------

-------------

-------------

-------------

BPM

P/F

P/F

P/F P/F

Checked:-_______


10/5/96 Page 3 of 3

Ref Operation\Description Value 2 Value 1 Units

5.19 PCV Test Default Settings

Monitored Peak (Value 2) delivered Peak (Value 1)


Return to default

PCV Test Inspired Flow



Return to default

-------------

-------------

-------------

-------------

-------------

-------------

------------- cm H20

cm H20

P/F

-------------

cm H2O

cm H2O

P/F

5.20 PEEP 500ml, 12 BPM, 1:2.0

Delivered minimum pressure (value 2), monitored PEEP (value 1)

Set 3 cmH20

Set 20 cmH20

Set 10 cmH20

PEEP set to OFF

cm H2O

cm H2O cm H2O P/F

5.21 Hardware Pressure Overload Cm H2O

5.22 Fresh Gas

0

1

3

5

10

LPM

LPM

LPM

LPM LPM

5.23 O2 Test

100%

50%

21%

OFF

-------------

-------------

-------------

-------------

%

%

%

P/F

5.24 Absorber

Language

O.E.M

----------- ----------- -----------

Y/N Lang

Name

5.25 Test completion, mode switch centre off. Check readings, sign and date all documents

Issue No: 4 Originator: JLB Checked: Date: ECN Ref: 3829


Title: Final Test 8500 Document No: 129TP000 Sheet 1 of 17


BQD 083.V2 25/5/94 Checked:-________

1.0 OBJECTIVES

To final test and provide a set of results for the 8500 Anaesthesia Ventilator.

2.0 SCOPE

The final test in conjunction with the checklist and calibration record (129TC000) should be completed whenever an 8500 Anaesthesia Ventilator is being readied for shipment from the factory.

This may be for Demonstration or Production purposes. It should also be used on ventilators which are going into stock, and are to be fully packed and for shipping within a few days.

WARNING - Under no circumstances should ANY part of the ventilator be opened or removed after this test procedure has been completed and signed off. This procedure is only valid for software versions 8.20 & 8.60 onwards.

3.0 OVERVIEW

The remaining sections of this document are:

Section 4 Test Limits Specification Section 5 Test Procedure Section 6 Using the Calibration Analyser

Section 4 contains the test limits for the final calibration checks. The test results noted for section 5 on the checklist and calibration record (129TC000) must be compared against these test limits for conformity.

Section 5 gives details of the test and calibration to be done with a list of test equipment. The section is written so that minimum adjustment of controls is done between each test. This means that any particular test assumes all previous tests have been set-up IN THE SEQUENCE STATED and passed. If this is not done, invalid results may be taken.

Section 6 gives a few pointers on using the Calibration Analyser with respect to this test procedure. A good place to start if you have not used this unit and/or have not used this test procedure for some time.

Issue 1 2 3 4 5 6

Change Note No n/a 3724 3829 3847 3866 3962

Originator JLB JLB JLB JLB JLB JLB

Checked DB RHC RHC RHC RHC

Date Nov 00 Dec 00 June 01 July 01 August 01



BQD 083.V2 25/5/94 Checked:-________

DURING TESTING, ALWAYS BE AWARE OF CORRECT VENTILATOR OPERATION AND LISTEN FOR ANY UNEXPECTED OR UNUSUAL NOISES FROM THE MACHINE AND ASSOCIATED TUBING, AS THIS MAY INDICATE A POTENTIAL PROBLEM. ALWAYS COMPLETE COMPLIANCE COMPENSATION AFTER SWITCHING THE VENTILATOR OFF AND BACK ON AGAIN. ALWAYS WAIT FOR COMPLIANCE COMPENSATION TO COME BACK ON BEFORE TAKING ANY READINGS.

4.0 TEST LIMITS SPECIFICATION

Sched. Function set Parameter Tolerance Units Ref. or tested Measured

5.3 Mains connected Mains Supply 90-265 Vac (500 Vdc) Mains insul Res 50 Mohms (25 A ac) Equip cont Res 0.2 Ohms Norm leakage 500 mA Revs leakage 500 mA O/C norm leakage 1000 mA

O/C revs leakage 1000 mA 5.8 Mute ON Mute times 120 2 sec 5.9 Supply alarm ON Supply gas pressure 34.5 - 36.0 psi Supply alarm OFF Supply gas pressure 36.0 psi

5.10 6 BPM/1:1.0 1.0 L delivered TV 0.93 - 1.07 L 10 BPM/1:2.0 1.0 L delivered TV 0.95 1.05 L 20 BPM/1:3 0.6 L delivered TV 0.55 - 0.65 L 20 BPM/1:2 0.2 L delivered TV 0.17 - 0.23 L 60BPM/1:1.0 0.2 L delivered TV 0.17 - 0.23 L 90BPM/1:2.0 0.1 L delivered TV 0.08 - 0.12 L NOTE: i.e. MAX = 1:5.1

The bellows deflection is affected by compliance compensation and this should be considered when judging the results.

A fresh gas supply of 0.25 L/m, will add about 10 ml to the breath at 6-10 BPM and can be ignored at higher rates. The above tolerances allow for this. Also included is additional 10 ml for Calibration Analyser display error. Delivered TV = Total TV / (1 + Vent compl/Pat compl) where ventilator adult compliance



BQD 083.V2 25/5/94 Checked:-________

3 ml/cm H2O, and vent paediatric compliance 2 ml/cm H2O. Total TV = Set TV + Fresh gas in L/m BPM Rate x (I + E)

At higher frequencies time delays due to compliances greatly affect delivered volumes and ratios.

5.10 Frequency tolerance at all BPM 1%

5.10 I:E Ratio tolerance at all BPM 10% or 0.1 whichever is larger.

Sched. Function set Parameter Tolerance

Ref. or tested Measured

5.11 Exp Vol 1 L Exp TV Delivered TV 10%

10 L Exp MV 10 x Exp TV 0.2

5.12 Patient Pressure vent monitor peak Delivered peak 1.5 Calibration vent monitor mean 20 3 cmH2O

Pressure high alarm High alarm setting Delivered peak 2 Pressure low alarm Low alarm setting Delivered peak 2

5.13 Adult Pressure Limit 50 cm H2O set 50 2 cm H2O

5.14 Apnoea Alarm Sensor disconnection time 30 5 sec

5.15 Cycle Alarm Sensor disconnection time 8 1 sec

5.16 Max TV Delivered TV 1.00 0.20/+0.05 L

Set TV Vents 50 ml bellows movement 50 10 ml

200 ml bellows movement 200 40 ml

5.17 Paed Pressure 20 cm H2O set 20 1 cm H2O

Limit Bellows position =100 ml

Sensor disconnection 21 1.5 cm H2O

5.18 ASB Test Delivered = Measured 1

5.19 PCV Test Delivered 1 cmH2O

Monitored 2 cmH2O

5.20 PEEP Test Set = measured 1 cm H2O

5.23 O2 Test Measured = set 2%



BQD 083.V2 25/5/94 Checked:-________

5.0 TEST PROCEDURE 5.1 Test Equipment and Setup ENSURE ALL TEST EQUIPMENT HAS A CURRENT CALIBRATION CERTIFICATE. The following items will be needed to perform all the checks in this procedure:

Timeter Calibration Analyser RT-200 with following options fitted: RT-201 Control Module, RT-202 Press Module, RT-203 Flow Module, or another Calibration Analyser.

The Timeter is supplied with its own pneumatic adapters for connection to hoses. See section 6.0 for details of Calibration Analyser usage.

Hyperterminal should be set up as follows: 9600 baud, 1 start and stop bit, 8 data bits. No handshaking is used. File should be saved as 8500.HT for further ref.

Electrical Safety Tester for earth leakage and continuity checks.

Stop Watch or other timepiece to measure up to 180 seconds.

5 0.25 L compliance, 20 1 L compliance, 50 2.5 L compliance, 20 2 cm H2O resistance.

Miscellaneous air and oxygen supply hoses provided with the ventilator, a variable 60 psi Air and/or Oxygen supply and a variable 0 to 20 L/m fresh gas source. Also a ventilator patient hose and one short hose.

Equipment Setup

The pneumatic equipment listed above is connected as shown below for adult tests. Minor alterations are done to this arrangement as the testing progresses. (All other Calibration Analyser connections must be left open to atmosphere).



BQD 083.V2 25/5/94 Checked:-________

20RResistor


CalibrationAnalyser




BQD 083.V2 25/5/94 Checked:-________

Test

1. Electrical safety tester test: Check the electrical safety tester meter rises to a value within the indicated 'test' region.

2. Supply: Note the mains supply voltage reading.

3. Insulation: Press the test switch on the electrical safety tester and note the insulation resistance reading.

4. Earth Continuity: put the test probe on one of the two screws adjacent to the mains inlet at the rear of the ventilator and repeat the test. Note the meter reading.

5. Earth/equipotential continuity: Place the electrical safety tester test probe on the equipotential connector at the rear of the ventilator. Press the test switch and again note the meter reading.

6. Normal Earth Leakage: Set the electrical safety tester Normal/Operate/Reverse switch to Normal and note the earth leakage current. Then set to Reverse and again note the earth leakage current.

7. Supply o/c Earth Leakage: Obtain the two earth leakage readings as in operation 6. (Normal and Reverse.

5.4 Fresh gas leak test

Connect spirometry tubing 10110089 from TJ92 to the fresh gas connections on the rear of the ventilator. Each side of the circuit is checked by pressurising it to 80 mmHg and checking that the pressure is maintained..

Fresh Gas Alarm

Set ventilator to Tv 0.5, BPM 12, I:E 1:2. The fresh gas alarm should go off when the fresh gas flow is greater than 11.8 LPM.

Set ventilator to Tv 0.25, BPM 12, I:E 1:2. The fresh gas alarm should go off when the fresh gas flow is greater than 5.9 LPM.

5.5 Printer Output Check

Connect the 8500 to the PC via the calibration port on rear the of the 8500 ventilator.

Run 8500.ht on the PC. Switch the ventilator ON and check that the calibration data is displayed on the dumb terminal.



BQD 083.V2 25/5/94 Checked:-________

5.6 Battery Back Up

Turn the ventilator OFF for at least 5 seconds and isolate from the mains supply.

Turn the ventilator ON to adult mode and listen for the vent mains fail alarm to activate.

Switch off the ventilator.

Reconnect the mains supply to the ventilator and observe that it starts up as normal.

Isolate from the mains supply again and verify the battery on charge indicator goes off after one minute and the mains fail alarm activates for a few seconds.

Verify that after one minute of mains failure the mains fail alarm activates again for a few seconds and the screen backlight goes off. Check the SET UP screen comes on and remains on until the next alarm sounds.

Reconnect the mains supply and check that the battery on charge indicator turns on and the mains fail indicator turns off.

5.7 Compliance test

Conect the ventilator using the relevant tubes, occlude the patient airway sensor. Switch the ventilator on and say yes compliance compensation. Follow the on screen instructions. If the compliance and leak tests are passed it is unlikely that there are any internal leaks.

Absorber Switching

The function of this will have been checked during compliance compensation and the presence of an absorber will have been displayed.

5.8 Mute Timeout

Press the Alarm menu button, select MUTE TIME and set 120 seconds.

Press MUTE while there is an alarm condition, and note the audio mute time.

5.9 Supply Gas Low Alarm

With the ventilator in standby mode, reduce the supply gas pressure until the gas supply low alarm just activates. Note the gas supply pressure.

Slowly increase the gas supply pressure until the gas supply alarm just deactivates and note the pressure.

Restore supply pressure to 60 PSI.



BQD 083.V2 25/5/94 Checked:-________

5.10 Ventilatory Control Functions

With the correct supply gas (oxygen/air), note the following delivered parameters at the stated control settings whilst ensuring no pressure limiting occurs: (Patient = 20C+20R, mode = adult run & min fresh gas.) After changing any settings wait for compliance compensation to come back on before taking any readings.

BPM TV(L) Ratio Delivered and Monitored Parameters to Note

6 1.0 1:1.0 Freq Ratio TV 6 1.0 1:Max Ratio 10 1.0 1:2.0 Ratio TV 20 0.6 1:3.0 Freq TV 20 0.4 1:Min Ratio 20 0.2 1:2.0 Ratio TV 40 0.2 1:2.0 Freq 60 0.2 1:1.0 Ratio TV 90 0.1 1:2.0 Freq Ratio TV

Max ratio for the 8500 is 1:5. Min ratio for the 8500 is inverse 2:1

5.11 Expired Volume and Alarms

Set ventilatory controls to: MV/TV = 10L/1000ml

Freq = 10 BPM

Ratio = 1:2.0

After one minute note the ventilator monitored MV and TV.

Reduce MV/TV to 4L/200ml and increase frequency to 20 BPM.

Press the Alarm menu button choose Alarm Limits and set MV Low alarm at 2.

Open a small leak in the airway and verify the MV low alarm turns on immediately the first MV reading occurs below 2.0 L (50% of set MV). Check active alarm stops 30 seconds after MV reading is increased to 2.0 L. (After the leak is closed off.) Set frequency to 20 BPM.

Set MV low alarm to 4 and MV high alarm to 6

Increase the fresh gas supply until the ventilator monitored MV rises to >6.0 L (> 150% of set MV) and verify the MV high alarm turns on immediately the first MV reading occurs above 6.0 L. Check active alarm stops 30 seconds after MV reading is reduced to 6.0 L. Set the MV high alarm to 25.



BQD 083.V2 25/5/94 Checked:-________

5.12 Patient Pressure and Alarms

Set ventilatory controls to: MV/TV = 10L/1000ml Freq = 10 BPM Ratio = 1:1.0.

After several breaths, note the delivered peak pressure, the ventilator monitored peak and mean pressures.

Reduce the pressure high alarm limit until a pressure high alarm just occurs and note the control setting. Restore control to default.

Increase the pressure low alarm limit until a pressure low alarm just occurs and note the control setting. Restore control to default.

5.13 Adult Pressure Limit

Set ventilatory controls to: MV/TV = 12L/1200ml Freq = 12 BPM Ratio = 1:2.0

Set pressure limit to 50 cm H20 and note the delivered peak pressure after several breaths.

Verify the pressure high alarm activates for a short period as the ventilator pressure cycles into expiration.

5.14 Apnoea

With the ventilator running normally, disconnect the lower (female) patient flow input just as expiration starts and note the time when the apnoea alarm activates for 30 seconds.

5.15 Ventilator Cycling Alarm

With the ventilator set to 20 BPM, 12 (600 ml TV), disconnect the lower patient flow input as before and note the time to when the pressure low alarm activates.

5.16 Flow and Waveform

Set ventilatory controls to: (Patient = C50)

TV = 1000ml, Freq = 25 BPM, Ratio = 1:2.0

After several breaths note delivered TV.

Exchange the adult bellows for a paediatric bellows and change the test lung to a 5C compliance



BQD 083.V2 25/5/94 Checked:-________

Switch the ventilator to paediatric mode and carry out compliance compensation as directed on screen: Set ventilatory controls to: TV = 0.5L/50ml Freq = 10 BPM Ratio = 1:2.5 Note bellows movement. Set ventilatory controls to: TV = 2L/200ml Freq = 10 BPM

Ratio = 1:2.0 Note bellows movement.

5.17 Paediatric Pressure Limit Set ventilatory controls to: TV = 6L/200ml Freq = 30 BPM

Ratio = 1:2.0

Set pressure limit to 20 cm H2O and note the delivered peak pressure after several breaths.

Note the bellows position.

Disconnect lower patient airway connector.

Note peak pressure. Switch the ventilator to Adult mode and carry out compliance compensation as directed on screen:



BQD 083.V2 25/5/94 Checked:-________

5.18 ASB Test

Tee into the circuit between the patient flow sensor and the resistor and attach TJ096. As shown opposite.

Set ventilator to ASB mode. Set trigger point to 5. Switch on TJ096 And ensure that BPM shown on 8500 matches BPM shown on the Calibration Analyser. Set trigger point to 10, check 8500 stops breathing and all associated alarms sound.

Return trigger point to 5, check that alarms clear and 8500 runs as normal.

5.19 PCV Test

Set vent mode to PCV.

With default set-up, note the delivered peak pressure and the monitored peak pressure.

Increase the pressure limit to 30. Again, note the delivered and monitored peak pressures.

Return to default settings and ensure that they are achieved.

Change the mode to allow inspired flow to be set. Repeat as above but when the pressure limit is raised to 30, raise the inspired flow to 50.

Allowable tolerances: delivered 1 cmH2O, monitored 2 cmH2O

20R Resistor

To TJ096

Patient FlowSensor



BQD 083.V2 25/5/94 Checked:-________

5.20 PEEP Test

Return circuit to as shown in 5.1. Set ventilatory controls to TV = 500ml , Freq = 12 BPM Ratio = 1:2.0. Set peep to 3cm H2O, check on the Calibration Analyser this is achieved within 5 breaths Set peep to 20cm H2O, check on the Calibration Analyser this is achieved within 5 breaths Set peep to 10cm H2O, check on the Calibration Analyser this is achieved within 5 breaths Set peep to OFF, check on the Calibration Analyser this is achieved within 2 breaths Allowable tolerances Set = measured 0.5cm H20

5.21 Hardware Pressure Overload

With the ventilator in Adult CMV mode with settings at default, connect to a C5 lung.

Run the Test I/O diagnostics as described in Section 5.4. Position the cursor on line 1 of

page 1, to disable software limiting.

Increase delivered volume until the hardware pressure limit is triggered. Note the peak

delivered pressure.

Press CNTL+E to exit the PC calibration screen

5.22 Fresh Gas

With the unit in STANDBY set flows below and record the measured values.

Set 0 LPM flow check 0 +0.1 LPM measured

Set 1 LPM flow check 1 0.2 LPM measured




5.23 O2 Test

Plug O2 sensor in to rear of 8500. Place sensor in gas flow and check that the reading is within 2% of the delivered O2 level at levels of 100%, 50% and 21%. Check that when the sensor is unplugged the display says OFF.



BQD 083.V2 25/5/94 Checked:-________

5.24 Dealer specific information

The following options can be set:

Absorber Present (default) / Not present

Language English (default), German, French, Spanish, Turkish, Italian

O.E.M Blease (default), A.M.S, Acoma, Finesa, User select

The Absorber switch setting can be found under setup enter the password TECHY

The Language and O.E.M settings can also be found under setup enter the password LINGO

If anything other than the default options are required then these should be set

All options should be recorded on the calibration record even if they are default.

5.25 Test Completion

Restore ventilator controls to default. Ensure mode on/off switch is in the OFF.

Check that all the noted readings are within the tolerances as specified in section 4.

Sign off the 'Checklist and Calibration Record' and the customer printout. Ensure both have the ventilator serial number, date and signature of final tester, etc.

If the original sticker over the hole in the calibration port on the rear of the ventilator was removed, replace with a new calibration void sticker.

Attach the required notification to the ventilator which states that the unit has passed its final test.

Calibration Gas As specified by model number Gas Convert Norm BAV Software Version 8.60 Front Panel Software Version 8.20 Ventilator Model No: Manufacture Date (part of serial no.) Calibration Date:

All options on second sheet are at default.

5.26 Printer Output

Connect the serial printer to the recorder output.

With no pneumatic connections attached, turn the ventilator ON (adult mode) and check that the printer starts operating after a few seconds. Note the output software version on the checklist and calibration record and any other details required in the record header.



BQD 083.V2 25/5/94 Checked:-________

5.27 Ventilator Catalogue Number/Model Summary

Cat No Description Notes

12900001 8500 90 - 260 Vac Adult USA O2 Driven 12900002 8500 90 - 260 Vac Paed USA O2 Driven 12900003 8500 90 - 260 Vac Adult UK O2 Driven 12900004 8500 90 - 260 Vac Paed UK O2 Driven

12900005 8500 90 - 260 Vac Adult USA Air Driven 12900006 8500 90 - 260 Vac Paed USA Air Driven 12900007 8500 90 - 260 Vac Adult UK Air Driven 12900008 8500 90 - 260 Vac Paed UK Air Driven



BQD 083.V2 25/5/94 Checked:-________

6.0 USING THE CALIBRATION ANAYSER

This section is intended to be guide in using the Calibration Analyser with this test procedure. It should be read in conjunction with the operating manual supplied with the Calibration Analyser.

6.1 Volume Measurement Correction

For volume measurements, the patient circuit is connected as shown in section 6.4, that is, with compliance connected to the High Flow Outlet of the Calibration Analyser. In this configuration, all Calibration Analyser volume measurements MUST HAVE A CORRECTION FIGURE ADDED TO THE INDICATED VALUE. A simple correction formulae is: At 500 ml 25cm H2O peak pressure \ mean pressure 12.5 Calibration Analyser reads 0.48 Lpm

Actual = (0.48 x (1+0.0125)) = 0.486 Lpm Where MEAN PRES is the breath mean pressure in cm H2O while there is measurable flow.

This formulae must be applied to ALL the Calibration Analyser volume readings BEFORE they are written on the Checklist and Calibration Record.

For example, given an indicated volume of 1.13 Litres and a mean breath pressure of 30 cmH2O. The actual volume would be:

= 1.13 ( 1 + 30/1000) = 1.13 x 1.03 = 1.16 Litres

Timeter specific information For other analysers consult their operating manual. The breath mean pressure need only be accurate to 5 cm H2O and could be obtained directly from the ventilators own pressure display. Alternately, Function Code 12 with the Peak Special Function could be selected on the Timeter to obtain the peak breath pressure. A ventilator supplying a constant gas flow produces a linear ramp change in pressure, hence the mean pressure is approximately half the peak pressure. (Normally a few cm H2O more due to compliance effects on pressure waveform.)



BQD 083.V2 25/5/94 Checked:-________

It is not unusual when measuring volume that the Timeter throws up an error message like 'HELP R' or 'HELP F'. All this means is that the Timeter had difficulty in identifying the start or end of a breath, possibly due to some pneumatic valve noise or reverse flow through the Timeter.

If it occurs a lot, it might be because there is a leak in the patient circuit, or the Timeter needs zeroing, or the patient circuit is moving/vibrating with the breath. These are a few things to check before assuming there is anything wrong with the ventilator.

6.2 Timeter Peak Pressure Measurements

If the ventilator has anything more than a few cmH2O of CPAP pressure, the Peak Pressure function on the Timeter will NOT operate. It will sit there forever showing the last peak pressure measured.

6.3 Timeter Zeroing and Power Up

When the Timeter is first switched ON, its sensors and electronics will need to be zeroed before the Function Codes will operate. This is simply done by pressing the Zero button provided after a Function has been selected and there are NO PNEUMATIC CONNECTIONS TO THE TIMETER.

The zeroing must be checked and done to all Functions periodically. The procedure is as follows:

a) Remove any tubing from the Timeter

b) Check the display reading. The display should read zero

c) If the display does not read zero, press the Zero button on the keypad. The display will now read zero

d) Resume testing

ALWAYS ALLOW AT LEAST 10 MINUTES WARM-UP AFTER INITIAL SWITCH ON BEFORE USING THE TIMETER.



BQD 083.V2 25/5/94 Checked:-________

6.4 Typical Calibration Analyser Equipment Set up

The equipment is connected as shown below. All other Calibration Analyser connections should be left open to atmosphere.

20RResistor


CalibrationAnalyser



Title: B.A.V. POWER SUPPLY PCB DocumentNo:129TP076 Sheet 1 of 5

Issue 1

Change Note No n/a

Originator JLB

Checked

Date


BQD 083.V2 25/5/94

1.0 OBJECTIVE

To set up and test power supply board 10100076 used with the Blease 8500 Anaesthetic Ventilator and record a set of test results using 129TC000 Checklist and Calibration Record

2.0 SCOPE

The test procedure should be used with newly manufactured boards. When successfully passed they can be placed into Blease stock after inspection.

3.0 OVERVIEW

All testing is done with the aid of a test jig (TJ 70), this provides power resistors and switching that allows the correct test loading to be applied. Five 3 digit LCD panel meters are also incorporated into the jig which are connected to the input and output power rails of the PSU board via its connectors.

The jig also contains a mains transformer and rechargable battery with circuits identical to that used in an 8500 Anaesthetic Ventilator. Hence any results noted will accurately reflect the board operation when it is eventually fitted into a ventilator.

Most of the testing uses an external DC variable supply, this avoids the need for a 'Variac' and also allows current limiting to be used.

WARNING - WHEN POWERING UP A BOARD FOR THE FIRST TIME ALWAYS USE THE CURRENT LIMIT. THIS WILL REDUCE THE RISK OF ANY PERSONAL INJURY OR DAMAGE TO THE BOARD IN THE EVENT OF A FAULT OCCURRING.

Test results must be noted on the checklist and calibration form 101TC00076. When testing is successfully completed, the form must be 'signed off' and the necessary 'pass' notification attached to the tested board.

The following procedure describes the adjustments and checks necessary to calibrate the board and set all the pre-set controls (if any) to achieve the specified performance. Inability to make these adjustments, or failure to meet the specification after these adjustments have been made, should be considered as a fault.



4.0 TEST DETAILS 4.1 Equipment

1. TJ 70 - Blease test jig (The jigs are serialised TJ 70A, TJ 70B, etc)

2. Variable DC power supply, 17-30 Vdc @ 2.5 Amp. The supply must have an adjustable current limit of 100 mA to 2.5 Amps.

3. Pair of short 4mm plug to plug leads for external DC supply to jig connection. 4. Miscellaneous short connection leads for attachment of test BAV supply board to jig (6 off). These will vary according to the issue of board tested. 4.2 Connections and Set up Connections for the test set up are shown below. (Not to scale)

4.3 Top Charge

The 'Top Charge' switch on the jig only functions when the 'simulated' battery is selected.

A passive circuit is used that kicks the board charger into continuous top charge mode as the switch is toggled down. It causes an increase in the charger load and also a temporary drop in voltage in the battery simulated.

If this does not work, the switch needs to be returned to the up position for a few seconds before toggling it back down again. If this still does not work, there may be a problem with the battery charger on the board under test.

2. External DC

Power Supply

1. Test jig TJ 70 (viewed from Top)

Jig Interface Board (Fixed to jig) - 10100177

PL0

PL7 PL4PL5PL8PL1PL2PL3PL6

Board under test - 10100076 BAV PSU

4. Misc Test Leads

PL4PL5

PL1

PL2PL3PL6

PL7

LK1LK2LK3

3. Test lead with 4mm plugs



4.4 Test Limits

These are provided on the Checklist and Calibration Record.

The battery volts for ops. 2, 3 & 4 may fall below the stated limits if the temperature of the board under test (IC3) rises above 21C.

For op. 12 the test limits (z+?) are referenced to the noted reading (z) for the unregulated supply voltage. 5.0 TEST SCHEDULE

See 4.0 TEST DETAILS for information on the test equipment and its use. Also covered are connection details, set ups, methods and test limits.

All operations in this section must be done in the order as written. 5.1 Preliminary

The board must NOT be attached to the test jig until operations 1 to 3 below are successfully completed.

1. Set all Test Jig switches to uppermost toggled position.

2. Set external DC supply to 0 volts with a 100 mA current limit.

3. Perform a visual quality check of the new board assembly. In particular:

look for any defects in the overall assembly.

check in more detail any areas that have been reworked/repaired for any defects.

check the boards and assembly against the production drawings, in particular the issue.

check all connectors are firmly seated.

Check all integrated circuits which have been fitted into sockets are correctly fitted. (Right way round, no bent pins, etc.)

check all links are fitted correctly.

LK1 is open.

LK2 and LK3 both have shorting links fitted. 5.2 No Load Voltages

With a current limit of 100mA set, slowly increase the external DC suppply voltage until the jig UNREG +25V meter reads 17.0 Vdc. The external supply will be about 2 volts higher than this.

Check there is no excessive supply current (< 100 mA) and that the jig BATT VOLTS meter settles to between 13.3-13.7 Vdc. (See 4.4 Test Limits)

Increase the external supply current limit to 400 mA and then toggle the jig PCB MODE switch to ON.

After a few seconds note the four supply voltages stated on the Checklist & Calibration Record.

Note - the external supply voltage may need to be increased slightly to maintain a constant test input voltage as shown on the UNREG +25V meter. This is mainly due to losses caused by the external supply connection leads which should be kept as short as possible.



5.3 On Load Volts

Set the external supply current limit to maximum ( 2.5 Amp) and then toggle the following five jig switches to ON:

TOP CHARGE +5V LOAD +6V LOAD FLOW VALVE DUMPVALVE

Note the four supply voltages stated. (UNREG +25V = 17.0 Vdc) 5.4 Regulation Volts

Increase the external DC supply voltage until the jig UNREG +25V meter reads 29.0 1 Vdc and note the four supply voltages again.

5.5 Off/On Check

Toggle the jig PCB MODE switch to OFF for a few seconds and then return to the ON position.

Apart from the BATT VOLTS supply, verify that the other three supplies turn OFF and are then restored to there previous value when the PCB MODE switch is turned back ON. 5.6 Battery Operational Check

Toggle the following three jig switches:

BATT to CONNECTED BATT RELAY to ON +6V SUPPLY to HOLD Reduce the external DC supply voltage to 0 Vdc and note the four supply voltages stated. 5.7 Alarm Operation

Toggle the jig ALARM SOUND switch to ON and verify the audio transducer on the board under test operates loudly. 5.8 Alarm Backup

Toggle the jig +24V RELAY switch to OFF and verify the volume of the alarm reduces by about half and that the REGUL +24V supply turns OFF.

Note the two supply voltages stated. 5.9 Alarm Links

Remove link 3 from the board under test and verify the volume of the alarm reduces by half and does not stop sounding.

Remove link 2 from the board under test and verify the volume of the alarm reduces by another half but does not stop sounding.

Insert link 1 and verify the alarm stops sounding.

Restore all three link positions (1 = open, 2 & 3 = closed).

5.10 Shut Down

Toggle the jig PCB MODE switch to OFF and verify the alarm stops sounding but the REGUL +6V supply is still present.

Toggle the jig +6V SUPPLY switch to NORM and verify the REGUL +6V supply turns OFF.

Note - the top charge LED may turn ON as the REGUL +6V supply turns OFF. This is normal and indicates the internal jig battery is being charged by the board under test.



5.11 Mains Operation

Toggle the following three jig switches:

ALARM SOUND to OFF +24V RELAY to NORM PCB SUPPLY to AC

After toggling the jig PCB MODE switch to ON, verify all supplies are restored to their nominal ON LOAD values. The BATT VOLTS may be a little low as charging is initiated due to previous testing.

Verify on the jig that the PCB SUPPLY lamp is similarly illuminated as the adjacent JIG SUPPLY lamp.

Note - the supply voltage to the board under test as shown on the UNREG +25V meter is protected by thermistors. These may trip if the board is allowed to run at full load for any length of time, particularly when running from AC.

To regain normal operation, turn OFF the jig external DC and mains supplies for a couple of minutes.

5.12 Unregulated Supply

Results for the following are affected by the mains supply voltage which should be at its nominal value of 240 Vac.

Note the value from the jig UNREG +25V meter.

Toggle the jig PEAK READ switch down and again note the value from the jig UNREG +25V meter.


Title 8500 B.A.V. Front Panel Document No: 129TP078 Sheet 1 of 1

Issue 1

Change Note No n/a

Originator AA

Checked

Date


BQD 083.V2 25/5/94

The front panel for the 8500 Anaesthesia Ventilator is functionally checked as part of the test procedure for the controller.

See test procedure 129TP077

1011SM02

REMOVE ALL BURRS AND SHARP CORNERS

Blease DRG.No.

DO NOT SCALE IF YOU HAVE ANY DOUBTS PLEASE ASK

REMOVE ALL BURRS AND SHARP CORNERS

1

2

3

4

A B

DRG.No.

IF YOU HAVE ANY DOUBTS PLEASE ASK

C D FE G

DO NOT SCALE

AUTO ZERO VALVE

AUTO ZERO VALVE

36psiDETECTORPRESSURESUPPLYLOW

POWER SUPPLY BOARDCONTROLLER BOARD

SWITCHPRESSURE

10110077

PL5 VALVESFLOW

10100076

2.5-7 BAR36-101 psiINLETSUPPLYGAS

REGULATORMAIN

34.5 psi

FLOW CONTROL VALVES

PT4

10110075PRESSURE INTERFACE BOARD

PRESSUREFLOWINSPIRATORY DRIVE

PT2

PNEUMOTACHOGRAPH

VALVEEXPIRATORY

SOLENOIDVALVE

DUMP

PRESSUREPATIENT

PT5

75cmH2O

VALVERELIEF

EXHAUSTPORT

PORTOUTLETGASDRIVE

-

-

-

-

????

1:1

1-00

JLB

1011SM03

1

PL4 PL8VALVEPEEP

AIRWAY FLOWPATIENT

GAS FLOWFRESH

PT1PT3

SENSOR INLETAIRWAY FLOW

SENSOR INLETFRESH GAS

VALVEPEEP

FILTER

DUMPVALVE

PL5

1 2 3 4 5 6 7 8

A

B

C

D

87654321

D

C

B

A

Title

Number RevisionSize

A3

Date: 4-Feb-2002 Sheet of File: \\Cad 3\c\1 JONS ARCHIVE\8500archive\circuit diagrams\10100076-9\10100076.ddbDrawn By:

TR1, IC1, IC2, IC4, D1 D2 and D10 are all mounted on the heatsinkblock.

2PL6-2PLM

1PL6-1PLM

TR2MPSA13

L41R0

EARTH-TRM3

TR10ZTX650

D16IN4448

2PL8-2

1PL8-1

TP4

TP3TP2

TP1

D13BAT42

TP7

TP6

TP10

TP9

TP5+29V Min

R3810K0

TR9ZTX650

R373K32

TP8

RL1RY6-10-006

24 PL1-24

12345678 9

10111213141516

IC3

12 PL1-12

R41R00

10 PL1-10

TO202-3P TO220-2P TO220-5P TO220-5P TO220-3P

20 PL1-20

18 PL1-18

7 PL1-7

11 PL1-11

16 PL1-16

13 PL1-13

14 PL1-14

5 PL1-5

R32100R

C1910u

D141N4002

R314K75

R3010K0LK1

LK2LK3

R2910K0

R282K21

R27475R

ALM1

TR8ZTX650

E-LINE

22 PL1-22

23 PL1-23

21 PL1-21

R262K21

RN2D2K2

RN2C2K2

RN2B2K2

RN2A2K2

RN1D2K2

RN1C2K2

RN1B2K2

RN1A2K2

D51N4448

C17100n

C1610u

R24100R

D121N4002

D111N4002

R16100R

TR7ZTX650

TR5ZTX650

R2347K5

D10PBYR745

TR6ZTX650

C1510u

R221K00

D6BAT42

R211R00

R2047R5

C14100n

R1910R0

9 PL2-9

3 PL2-3

2 PL2-2

2 PL3-2

1 PL3-1

D41N4448

1 23

45IC2

LM2577TADJ

9 PL1-9

19 PL1-19

C7100n

C6100n

R10365K

R930K1

R839K2

R7110K

D3BAT49

R61K00

R51K00

R31R00

TR1TIP30A

C22200u

1 2

3 45

IC1LM2576TADJ

D1 C3470u

L1220uH

26 PL1-26

15 PL1-15

17 PL1-17

3 PL1-3

1 PL1-1

25 PL1-25

BR1 GBPC802

1

2REG-SINK

2

1

BAT1

C8100n

RT1MFR300

2 PL7-2

1 PL7-1

C5470u

C9470U

R332K74

C10220n

R112K00

R1247K5

D2PBYR745

L5220uH

C1100n

R132K00

R14

7K87

R1510K0

L2100uH

C412u

L3100uH

C1110u

3 2

1

IC4LM317AT

R174K75

R18240R

C1310u

TR3ZTX650

TR4ZTX650

1 PL4-1

2 PL4-2

1 PL5-1

2 PL5-2

D7IN4002

D8IN4002

D91N4448

13

2

IC5LM341P5

C1210u

1 PL2-1

3 PL3-3

4 PL3-4

R11K50

R21K50

D151N4002

C1810u

4 PL2-4

6 PL2-6

8 PL2-8

10 PL2-10

2 PL1-2

4 PL1-4

6 PL1-6

8 PL1-8

R25475R

TO220-3P

RL2RY6-10-006

R34100R

R351K00

C201n

C211n

R361K00

1

CHASSIS

RELAY-8ATO92

4

T1A

T1A

Battery

ICCFLW

ICCSOL

ALMSIG

ALM+5V

+24V

+25V

VBAT

ON-LE

manual de entrenamiento ventilador de anestesia blease 8500

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