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Technical Documentation IPM

Fabius plus
Inhalation Anesthesia Machine

Warning

All servicing and/or test procedures on the


device require detailed knowledge of this
documentation. Use of the device requires
detailed knowledge and observance of the
relevant Instructions for Use.
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2 Fabius plus Technical Documentation IPM


Table of contents

Table of contents

General 5
1 General notes ........................................................................................................................... 6
Function descriptions 9
1 System overview ...................................................................................................................... 10
2 Leak test ................................................................................................................................... 13
3 Ventilation modes ..................................................................................................................... 15
Function descriptions pneumatic assembly 23
1 Ventilator .................................................................................................................................. 24
2 Pneumatic assembly ................................................................................................................ 28
3 Function description of the gas box .......................................................................................... 30
4 SORC (Sensitive Oxygen Ratio Controller) .............................................................................. 32
5 Cosy 2.6 breathing system ....................................................................................................... 34
6 Anaesthetic vaporizer ............................................................................................................... 37
7 Semi-open adapter ................................................................................................................... 38
8 Wall-mounted unit..................................................................................................................... 42
Function descriptions - Electronics 45
1 Control PCB.............................................................................................................................. 46
2 Electrical block diagram............................................................................................................ 47
3 Control unit ............................................................................................................................... 48
4 Battery backup.......................................................................................................................... 50
5 FiO2 measurement ................................................................................................................... 51
6 Respiratory Flow Measurement................................................................................................ 53
Parts catalog and test instructions 55
1 Parts catalog............................................................................................................................. 56
2 Test Instructions / Service Card IPM ........................................................................................ 115
3 Result Sheet Test instructions / Service Card IPM................................................................... 166
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General

This chapter contains general notes and definitions that are important for the
use of this documentation.

1 General notes ........................................................................................................................... 6


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General
General notes

1 General notes

1.1 Notes on use


Read through the following notes thoroughly before applying this
documentation.

The warnings set out here apply to all parts of this documentation.

Dräger reserves the right to make changes to the device and/or to this
documentation without prior notice. This documentation is intended solely as
an information resource for maintenance personnel or technical specialists.

1.2 Copyright and other protected rights


The content of this documentation, in particular its design, text, software,
technical drawings, configurations, graphics, images, data and their selection
and its composition and any amendments to it (content) are protected by
copyright. The content must not (in whole or in part) be modified, copied,
distributed, reproduced, republished, displayed, transmitted or sold without
the prior written consent of Dräger.

1.3 Definitions

WARNING
An important advisory indicating a potentially hazardous situation
which may result in death or serious injury if not prevented.

CAUTION
An important advisory indicating a potentially hazardous situation which may
result in minor or moderate injury to the user or patient or in damage to the
medical product or other assets if not prevented.

NOTE
A NOTE provides additional information intended to avoid inconvenience
during operation and/or servicing.

Term Definition
Maintenance Maintaining the operative condition of a medical product
by suitable means
Inspection Assessment of the actual condition of a medical product
Servicing Maintaining the operative condition of a medical product
by recurrent, specified measures
Repair Restoring the operative condition of a medical product
after failure of a device function

1.4 General safety precautions


No.3103_0000001949

Read through each section thoroughly before beginning servicing. Always


use the correct tools and the specified test equipment. Otherwise the device
may not work correctly or may be damaged.

6 Fabius plus Technical Documentation IPM


General
General notes

WARNING
The device must be regularly inspected and serviced by maintenance
personnel. Repairs and complex maintenance work on the medical
product must be carried out by qualified specialists.
If you require a service contract, or for any necessary repair work,
Dräger recommends DrägerService. Dräger recommends using
original Dräger parts for servicing.
If the aforementioned instructions and recommendations are ignored,
the correct functioning of the medical product may be put at risk. Pay
attention to the "Servicing" section of the Instructions for Use.

WARNING
Non-conforming test values
If test values do not conform to specifications, the safety of the patient
may be put at risk.
– Do not put the device into operation if test values do not conform to
specifications.
– Contact your local service organization.

WARNING
Impermissible modifications to the device
If impermissible modifications are made to the device, the safety of the
patient may be put at risk.
Do not modify the device without Dräger's permission.

WARNING
Risk of infection
The unit may transmit pathogens following use on the patient.
– Before carrying out any servicing, ensure that the device and its
components have been handed over by the user cleaned and
disinfected.
– Service only cleaned and disinfected units and unit components.

WARNING
Risk to patient.
Ensure that no patient is connected to the device before starting
maintenance or repair work.

NOTE
Where reference is made to legislation, regulations and standards, in
respect of devices used and serviced in Germany they are based on the
laws of Germany. Users and technicians in other countries must comply with
their national laws and/or international standards.
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Function descriptions

This chapter contains descriptions of the device's technical functions.

1 System overview ...................................................................................................................... 10


2 Leak test ................................................................................................................................... 13
3 Ventilation modes ..................................................................................................................... 15
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Function descriptions
System overview

1 System overview

1.1 Introduction
The following text describes the structure, the functional principle, and the
connections of the Fabius plus.

1.2 Design
The Fabius plus comprises the following assemblies:
– Display unit and control panel
– Flowmeter block
– Gas inlet block
– Compact breathing system
– Pneumatic assembly
– Ventilator
– Vapor anaesthetic agent vaporizer
– Trolley

1.3 Functional principle


The Fabius plus is an inspiratory anaesthetic unit with continuous flow.

The integrated components monitor the airway pressure, the volume, and the
fraction of inspired oxygen.

1.4 Connections, interfaces, and components

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5026

Fig. 1 Front view of Fabius plus

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Function descriptions
System overview

No. Designation
1 Compact breathing system
2 Ventilator
3 Interlock Vapor mount
4 O2 flush
5 Control panel (settings for ventilation parameters and airway
monitoring)
6 Monitor
7 Manometer for pin-index cylinders (O2, N2O)
8 Flowmeter block
9 Valves for fresh-gas metering
10 Trolley
5030

Fig. 2 Rear view of Fabius plus, control box

No. Designation
1 COM1 (serial port)
2 APL (tube connector for APL bypass valve)
3 PEEP (tube connector for PEEP valve)
4 Oxygen sensor connection
5 Positive pressure ventilation (airway pressure connector)
6 Volume sensor (Spirolog sensor)
7 Power cord strain relief
No.3103_0000001949

8 Power cord connection (with fuses)


9 ON/OFF switch
10 Battery fuse

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Function descriptions
System overview

5027

Fig. 3 Rear view of Fabius plus, gas inlet block

Item Designation
1 Three vertically-arranged inlets for pipeline gas supply (from top to
bottom: N2O, AIR and O2)
2 Three vertically-arranged inlets for the reserve gas cylinders (from
top to bottom: N2O, AIR and O2) (optional)
3 Pin-index connector for N2O or AIR (optional)
4 Pin-index connector for O2 (optional)

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Function descriptions
Leak test

2 Leak test

The "Leck-/Compl-Test" menu screen provides instructions on how to start


the leakage test.

The test starts after the device self-test.

If the measured leak is outside the tolerance range, an appropriate on-screen


message is displayed telling that the system leakage test has failed.

NOTE
With sidestream monitoring, seal off the sampling tube from the Y-piece,
otherwise there will be an additional leak rate of 150 mL/min to 200 mL/min.

2.1 System leakage (compliance calculation)


The "Leck-/Compl-Test" menu prompts the user to do the following:
– Close the fresh gas valves.
– Connect the Y-piece.
– Set the Man/Spont valve to "Man".
– Set the pressure to 40 mbar to 50 mbar.

The motor control moves the piston upward.


– Activate the O2 flush to set a system pressure between 15 mbar and
30 mbar.

The software monitors the airway pressure.


– If the airway pressure is within permissible range, the airway pressure is
then allowed to drop for 15 seconds or by 1.5 mbar.

If no appreciable pressure drop occurred in 15 seconds, the leakage test is


considered "passed".

If the pressure has decreased significantly (up to 1.5 mbar), the piston will
move upward until the airway pressure has increased 2 mbar, or the piston
has moved upward a specific volume of 160 mL, whichever comes first.

The upward piston movement in mL, divided by the increase in airway


pressure yields the system compliance value. This compliance value is used
when calculating the system leak rate only. The system compliance is
calculated in the next step upon completion of the system leakage test.

A system compliance value of up to 6.5 mL/cmH2O (6.5 mL/hPa) is displayed


on-screen with the leak test results as »OK«.

The total time that elapsed between the start of the piston movement and the
transition pressure drop by 1.5 mbar is the time base for the leak calculation.

The result of the "system leakage" test is displayed.


No.3103_0000001949

System leak test value Displayed result


[mL/min] [mL/min]
≤250 Measured value and "PASS"

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Function descriptions
Leak test

System leak test value Displayed result


[mL/min] [mL/min]
251 to 350 Measured value and "FAIL"
>350 >350 and "FAIL"

High system leakage, alongside other leakage, may also be caused by a


faulty sum total flowmeter.

2.2 Ventilator leakage


The ventilator leakage test is done in a similar way to the system leakage
test:

The PEEP/Pmax valve is used to close off the expiratory part of the
pneumatic circuit. Only the patient circuit is tested.

The test begins by opening the PEEP valve. Also a check is made to locate
the piston.

If the piston is above the desired starting position the piston is servoed
downward.

If the piston is below the desired starting position the piston is servoed
upward.

Then the PEEP valve is closed and so only the ventilator circuit is checked.

The piston is moved upward.

When the airway pressure has reached 30 mbar, the piston is paused at that
position and maintained there by the servo function.

Once the pressure has stabilized, the state changes to "waiting for leak."

When the airway pressure and ventilator pressure have dropped 1 mbar or
the elapsed waiting time exceeds 20 seconds, the state changes to
calculation of the leak in mL and leak rate in mL/min.

The software detects that the completion state has gone to "Pass" or "Fail"
and then displays the leakage test results on-screen, or displays an
appropriate error message if one of the error conditions is met.

The result of the "ventilator leakage test" is displayed after each test.

Ventilator leak test value Displayed result


[mL/min] [mL/min]
≤150 Measured value and "PASS"
151 to 250 Measured value and "FAIL"
>250 >250 and "FAIL"
No.3103_0000001949

2.3 Valve test


After completion of the leakage test and compliance test, the auxiliary air
valve, the pressure limiting valve, and the PEEP/Pmax valve are tested.

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Function descriptions
Ventilation modes

3 Ventilation modes

5534

Fig. 4 Function diagram of ventilation modes


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Function descriptions
Ventilation modes

Key to all the following ventilation modes

Item Designation
1 Manual breathing bag
2 Fresh gas inlet
3 Fresh gas isolation
4 Ventilator
5 Inspiratory valve
6 Pressure sensor
7 Oxygen sensor
8 Inspiratory tube
9 Y-piece
10 Lung
11 Expiratory tube
12 Flow sensor
13 PEEP/Pmax valve
14 Expiratory valve
15 APL bypass valve
16 APL valve
17 Non-return valve
18 Absorber

3.1 Function Description: Manual ventilation


Manual ventilation: During manual ventilation, the APL valve is set to the "MAN" position. The
General safety valve of the ventilator is additionally active. The piston of the ventilator
is moved up in order to reduce the ventilator volume.

The item numbers in the following paragraph refer to Fig. 5.

Manual ventilation: During inspiration, expiratory valve 14 remains closed. When the operator
Inspiration compresses the breathing bag 1 the gas mixture (expiratory gas and fresh
gas 2) flows through the fresh gas isolation valve 3, the inspiratory valve 5,
the O2 sensor 7, the inspiratory tube 8, and the Y-piece 9 into the patient’s
lung 10. The pressure sensor 6 measures the airway pressure. The
ventilation pressure is limited by the APL valve 16. Any excess amount of the
gas mixture flows through the APL valve and the non-return valve 17 to the
anaesthetic gas scavenging system.
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Function descriptions
Ventilation modes

4207

Fig. 5 Manual ventilation (inspiration) - Cosy 2.6 breathing system

Manual ventilation: During expiration, the inspiratory valve remains closed thus preventing the
Expiration – Cosy 2.6 expiratory gas from flowing back into the inspiratory branch.
breathing system
The item numbers in the following paragraph refer to Fig. 6.

After releasing the breathing bag 1, the expiratory gas from the lung 10 flows
through the expiratory tube 11, the flow sensor 12, the PEEP/Pmax valve 13,
the expiratory valve 14 and through the absorber 18 into the breathing bag.
At the same time, new fresh gas 2 flows into the manual ventilation bag.
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Function descriptions
Ventilation modes

4209

Fig. 6 Manual ventilation (expiration) - Cosy 2.6 breathing system

3.2 Function Description: Spontaneous breathing


Spontaneous breathing: A prerequisite for spontaneous breathing is that the patient is supplied with a
General sufficient amount of fresh gas. The APL valve selector must be set to the
"SPONT" position. No gas pressure builds up in the compact breathing
system.

Spontaneous breathing: During inspiration, the expiratory valve remains closed thus preventing
Inspiration rebreathing of expiratory gas containing CO2.

The item numbers in the following paragraph refer to Fig. 7.

The patient inhales the gas mixture (expiratory gas and fresh gas 2) from the
manual ventilation bag 1. The gas mixture flows through the fresh gas
isolation valve 3, the inspiratory valve 5, the O2 sensor 7, the inspiratory tube
8, and through the Y-piece 9 into the lung 10. The pressure sensor 6
measures the airway pressure.
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Function descriptions
Ventilation modes

4211

Fig. 7 Spontaneous breathing (inspiration) - Cosy 2.6 breathing system

Spontaneous breathing: During expiration, the inspiratory valve remains closed thus preventing the
Expiration – Cosy 2.6 expiratory gas from flowing back into the inspiratory branch.
breathing system
The item numbers mentioned in the following paragraphs refer to Fig. 8.

The APL valve 16 is open, irrespective of its pressure setting.

The expiratory gas flows from the lung 10 through the expiratory tube 11, the
flow sensor 12, the PEEP control valve 13, the expiratory valve 14 into the
manual ventilation bag 1. At the same time, new fresh gas 2 flows through the
absorber 18 into the breathing bag .

When the manual ventilation bag is full, any excess gas mixture flows through
the non-return valve 17 into the anaesthetic gas scavenging system.
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Function descriptions
Ventilation modes

4213

Fig. 8 Spontaneous breathing (expiration) - Cosy 2.6 breathing system

3.3 Function Description: volume/pressure control ventilation mode


volume control ventilation A prerequisite for volume control ventilation is that the patient is supplied with
mode: General a sufficient amount of fresh gas.

The APL bypass valve opens in volume ventilation mode, allowing excess
gas to be vented to the scavenging system regardless of the MAN/SPONT
valve setting.

The safety valve of the lung ventilator makes sure that no pressures greater
than 75 cmH2O (mbar) build up in the system.

During ventilation, the pressure limit (Pmax) can be adjusted at the user
interface.

Volume/pressure control During inspiration, the PEEP/Pmax valve remains closed. The control
ventilation mode: pressure present at the PEEP/Pmax valve varies with the set pressure limit
Inspiration (Pmax).

The item numbers mentioned in the following paragraphs refer to Fig. 9.


No.3103_0000001949

The pressure generated by the piston 4 of the ventilator closes the fresh gas
isolation valve 3. The gas mixture (expiratory gas and fresh gas 2) flows
through the inspiratory valve 5, the O2 sensor 7, the inspiratory tube 8, and
the Y-piece 9 into the lung 10. The pressure sensor 6 measures the airway

20 Fabius plus Technical Documentation IPM


Function descriptions
Ventilation modes

pressure. The ventilation pressure cannot exceed the pressure limit (Pmax)
set on the control box because the PEEP/Pmax valve 13 opens. The fresh
gas then fills the manual ventilation bag 1.

Any excess fresh gas flows through the open APL bypass valve 15, and the
non-return valve 17 into the anaesthetic gas scavenging system.

4215

Fig. 9 Volume-controlled ventilation (inspiration) - Cosy 2.6 breathing


system

Volume/pressure control During expiration, the inspiratory valve remains closed thus preventing
ventilation mode: rebreathing into the inspiratory branch.
Expiration
The item numbers mentioned in the following paragraphs refer to Fig. 10.

The expiratory gas from the lung 10 flows through the expiratory tube 11, the
flow sensor 12, the PEEP/Pmax valve 13, the expiratory valve 14, and the
absorber 18 back into the manual ventilation bag 1 mixing with fresh gas 2
also flowing into the manual ventilation bag.

The ventilator's piston 4 moves back drawing the gas mixture needed for the
next inspiration into the piston space.

Any excess fresh gas flows through the open APL bypass valve 15, and the
No.3103_0000001949

non-return valve 17 into the anaesthetic gas scavenging system.

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Function descriptions
Ventilation modes

4217

Fig. 10 Volume-controlled ventilation (expiration) - Cosy 2.6 breathing


system

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Function descriptions pneumatic
assembly

This chapter contains descriptions of the device's technical functions.

1 Ventilator .................................................................................................................................. 24
2 Pneumatic assembly ................................................................................................................ 28
3 Function description of the gas box .......................................................................................... 30
4 SORC (Sensitive Oxygen Ratio Controller) .............................................................................. 32
5 Cosy 2.6 breathing system ....................................................................................................... 34
6 Anaesthetic vaporizer ............................................................................................................... 37
7 Semi-open adapter ................................................................................................................... 38
8 Wall-mounted unit..................................................................................................................... 42
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Function descriptions pneumatic assembly
Ventilator

1 Ventilator

The ventilator is located in a swing-out compartment at the left side of the


Fabius. The ventilator is connected to the Cosy via a tube. Fresh gas is
delivered to the patient by a piston that is driven by a motor and ball-screw
arrangement. A sight window on the compartment allows the operator to
verify movement of the piston.

Two seals (upper and lower) form a bag-type rolling seal that surrounds the
piston. The pneumatic assembly generates a vacuum between the seal and
the cylinder, to ensure proper operation of the upper seal during piston
movement.

During inspiration, the ventilator delivers fresh gas at a given volume,


pressure and frequency. These parameters are set at the control panel. Refer
to the instructions for use for details on ventilator settings, displays and
controls.

The ventilator motor is controlled by the Control PCB. A light barrier on the
ventilator signals the Control PCB when the piston reaches its lower limit. An
incremental encoder on the motor shaft determines the number of revolutions
and provides piston travel information to the Control PCB.

The ventilator pressure is monitored by a pressure sensor on the Control


PCB. When the auxiliary-air valve on the patient system opens, a fresh gas
low alarm is generated, provided that it has been enabled in the service
mode.

The ventilator pressure sensor is the same type as the one used for
measuring airway pressure. The ventilator pressure is picked up at the
ventilator cover. This sensor allows the software to detect a fresh gas low
situation. In normal use the primary cause for this condition is an insufficient
amount of reserve gas in the manual breathing bag. The operator is alerted
when this condition exists, with a medium priority "FRESH GAS LOW" alarm.
This alarm can be disabled in service mode.

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Function descriptions pneumatic assembly
Ventilator

4218

Fig. 11 Ventilator (piston shown in ‘down’ position)

Item Designation
1 Ventilator housing
2 Safety valve
3 Auxiliary air valve
4 Ventilator pressure sensor line
5 Vacuum line to the pneumatic assembly
6 Upper seal
7 Piston
8 Lower seal
9 Motor/ballscrew assembly
10 Incremental encoder
11 Light barrier

The top of the ventilator assembly (patient system) contains two valves:
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Technical Documentation IPM Fabius plus 25


Function descriptions pneumatic assembly
Ventilator

1.1 Safety valve


If the pressure limit control fails, the ventilator's safety valve limits the gas
pressure. This valve opens at approximately 75 cmH2O (mbar).

4219

Fig. 12 Sectional view of the safety valve

Item Designation
1 Screw
2 Spring
3 Crater
4 Washer
5 Valve disk

1.2 Auxiliary air valve


The auxiliary air valve allows infeed of ambient air if the fresh gas supply is
inadequate or the medical gas supply and/or the Fabius fail(s). The opening
pressure of this valve is -8 mbar.
8050

No.3103_0000001949

Fig. 13 Sectional view of the auxiliary air valve

26 Fabius plus Technical Documentation IPM


Function descriptions pneumatic assembly
Ventilator

Item Designation
1 Threaded ring
2 Valve disk
3 Valve cross with spring
4 Connecting screw
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Function descriptions pneumatic assembly
Pneumatic assembly

2 Pneumatic assembly

The pneumatic assembly provides pressure for the PEEP valve control, and
also provides vacuum for the ventilator bag-type rolling seals and the APL
bypass valve control.

2.1 PEEP/Pmax valve control


When the Fabius is operating in automatic mode, the pump on the pneumatic
assembly is running and the electronic PEEP valve is actuated by the Control
PCB. The current supplied to the coil of the electronic PEEP valve is
proportional to the set PEEP value, and controls the position of the
diaphragm within the electronic PEEP valve. This then determines the control
pressure applied to the proportional PEEP valve in the breathing system,
which maintains the desired amount of PEEP during patient expiration. The
volume V1+ V2 smoothes out pressure fluctuations caused by the pump on
the pressure side. Refer to Fig. 14.
19125

Fig. 14 Schematic of the pneumatic control

2.2 APL bypass valve control


When the Fabius is operating in automatic ventilation mode, the pneumatic
assembly provides a vacuum signal to hold open the APL bypass valve in the
compact breathing system.

The fixed metering smoothes out pressure fluctuations. The filter provides
noise damping.
No.3103_0000001949

The variable restrictor is used to set the negative pressure level in a range of
–150 mbar (cmH2O) to –240 mbar (cmH2O).

28 Fabius plus Technical Documentation IPM


Function descriptions pneumatic assembly
Pneumatic assembly

When the device is operating in manual ventilation mode, the pump on the
pneumatic assembly (and the ventilator) is stopped, and the spring-loaded
APL bypass valve in the breathing system closes, directing exhaled gas
through the APL valve.
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Function descriptions pneumatic assembly
Function description of the gas box

3 Function description of the gas box

The supply gases flow through the filters and non-return valves in the gas
inlet assembly. Pipeline supply pressures are indicated on pipeline
manometers located on the flowmeter assembly. High-pressure cylinder
manometers are located on the trolley assembly. The cylinder pressure
regulators for PIN index are built-in to the gas box. The pressures of O2 and
N2O delivered to the flowmeter assembly are set by regulators on the gas
inlet assembly.

If the O2 supply fails or its pressure decreases below a certain limit, the O2
low alarm switch generates an alarm.
4133

Fig. 15 Gas box function diagram, part 1

If the O2 flush key is pressed, oxygen is delivered to the fresh gas outlet. The
fresh gas ejector prevents the fresh gas from flowing back into the
anaesthetic vaporizer. This avoids an increase in anaesthetic gas
concentration.
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Function descriptions pneumatic assembly
Function description of the gas box

9586

Fig. 16 Gas box function diagram, part 2


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Function descriptions pneumatic assembly
SORC (Sensitive Oxygen Ratio Controller)

4 SORC (Sensitive Oxygen Ratio Controller)

The SORC is a control element. The SORC makes sure the fresh gas always
contains a vital O2 concentration.

In the event of an O2 shortage, the SORC limits the N2O flow such that the
O2 concentration in the fresh gas does not decrease below 23 vol.%.

If the O2 flow control valve is closed or if the O2 flow is lower than or equal to
200 mL/min, the SORC interrupts the N2O flow.

N2O can be added as of an O2 flow of approx. 300 mL/min. In this case, the
SORC also prevents O2 concentrations below 23 vol.%.

The SORC bypass valve allows oxygen to bypass the restrictor in the SORC
when O2 flows above 10 L/min are needed.
9587

Fig. 17 SORC function diagram, part 1

The O2 and N2O flows are adjusted with the flow control valves.

Resistors located at the outlets of the SORC generate back-pressures. These


back-pressures exert a force on the control diaphragms of the SORC. The O2
back-pressure opens the SORC. The N2O back-pressure closes the SORC.
The pressure ratio at the control diaphragm affects the N2O flow.

The resistors and the spring force are dimensioned such that a minimum
concentration of 23 vol.% of O2 is always ensured. The maximum O2 flow is
approx. 12 L/min.
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Function descriptions pneumatic assembly
SORC (Sensitive Oxygen Ratio Controller)

4221

Fig. 18 SORC function diagram, part 2

Item Designation
1 Control diaphragms
2 Resistors
3 N2O non-return valve
4 Operating-point adjusting screw
5 Flow control valves
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Function descriptions pneumatic assembly
Cosy 2.6 breathing system

5 Cosy 2.6 breathing system

The Cosy 2.6 breathing system is a semi-enclosed system.

Using a semi-open adapter, the Cosy 2.6 can be turned into a semi-open
breathing system.

On the Cosy 2.6 the absorber is between the manual breathing bag and the
fresh gas connector.

The Cosy 2.6 breathing system allows three modes of patient ventilation:
– manual ventilation and spontaneous breathing
– volume control ventilation
– pressure control ventilation

On APL valves with rotary knob, switching from "IPPV/SPONT" to "MAN" is


carried out by turning the knob.

In the "MAN" position, the breathing system is closed to atmosphere. This


position is used for manual ventilation of the patient. The APL valve opening
pressure can be adjusted from 5 to 70 mbar.

In the "SPONT" switch position the APL valve is open to atmosphere. This
position is used for spontaneous breathing.

Using the control box and the PEEP/Pmax valve, the pressure limit (Pmax)
can also be adjusted during volume controlled ventilation between 15 and
70 mbar via the keypad.

The absorber canister is filled with fresh soda lime. The CO2 is scrubbed from
the expiratory gas by the soda lime.

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Function descriptions pneumatic assembly
Cosy 2.6 breathing system

4136

Fig. 19 Cosy 2.6 breathing system

Item Designation
1 Inspiratory connection
2 Pressure sensor connection (not visible)
3 Inspiratory valve and O2 sensor connection
4 Fresh gas isolation valve
5 APL bypass valve
6 PEEP/Pmax valve
7 MAN/SPONT APL valve
8 Anaesthesia monitor return line (only for systems outside the
USA)
9 Fresh gas port
10 Ventilator connection
11 Anaesthetic gas scavenging port
12 Absorber
No.3103_0000001949

13 Breathing bag terminal and standby holder for Y-piece


14 Breathing bag hook
15 Flow sensor (Spirolog) (not shown)

Technical Documentation IPM Fabius plus 35


Function descriptions pneumatic assembly
Cosy 2.6 breathing system

Item Designation
16 Expiratory connection
17 Expiratory valve

4130

Fig. 20 Function diagram of Fabius – Cosy 2.6 breathing system


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Function descriptions pneumatic assembly
Anaesthetic vaporizer

6 Anaesthetic vaporizer

Refer to separate technical documentation of the anaesthetic vaporizer.


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Function descriptions pneumatic assembly
Semi-open adapter

7 Semi-open adapter

The semi-open adapter is used in conjunction with the Cosy 2.6 patient
system.

7.1 Manual ventilation: General information


The item numbers mentioned in the following paragraphs refer to Fig. 21.

During manual ventilation, the APL valve 10 is set to the "MAN" position. The
safety valve of the ventilator 4 is additionally active. The ventilator's piston
has moved to a lower position.

7.2 Manual ventilation: Inspiration


When the operator compresses the breathing bag 1 the gas mixture
(expiratory gas and fresh gas 2) flows through the fresh gas decoupling valve
3, the inspiratory valve 5 and the O2 sensor 7 into the patient’s lung 8.

The pressure sensor 6 measures the airway pressure. The pressure exerted
on the manual breathing bag 1 closes the exhaust gas scavenging line in the
semi-open adapter 12. The ventilation pressure is limited by the APL valve
10. Any excess amount of the gas mixture flows through the APL valve 10
into the anaesthetic gas scavenging system 11.

No.3103_0000001949
4801

Fig. 21 Manual ventilation, inspiration

38 Fabius plus Technical Documentation IPM


Function descriptions pneumatic assembly
Semi-open adapter

7.3 Manual ventilation: Expiration


The item numbers mentioned in the following paragraphs refer to Fig. 22

During expiration, the inspiratory valve 3 remains closed thus preventing the
expiratory gas from flowing back into the inspiratory branch.

After releasing the breathing bag 1, the expiratory gas from the lung 4 flows
through the flow sensor 5, the PEEP/Pmax valve 6, the expiratory valve 7
and anaesthetic gas scavenging line of the semi-open adapter 11. At the
4824 same time, new fresh gas 2 flows into the manual breathing bag 1.

Fig. 22 Manual ventilation, expiration

7.4 Spontaneous breathing: General information


The item numbers mentioned in the following paragraphs refer to Fig. 23.

A prerequisite for spontaneous breathing is that the patient is supplied with a


sufficient amount of fresh gas. The switch of the APL valve 11 must be set to
"SPONT". No gas pressure builds up in the compact breathing system.

The piston of the ventilator 4 is at a lower position.


No.3103_0000001949

Technical Documentation IPM Fabius plus 39


Function descriptions pneumatic assembly
Semi-open adapter

7.5 Spontaneous breathing: Inspiration


During inspiration, the expiratory valve 10 remains closed thus preventing
rebreathing of expiratory gas containing CO2.

The patient inhales the gas mixture and fresh gas 2 from the manual
breathing bag 1. The gas mixture flows through the fresh gas decoupling
valve 3, the inspiratory valve 5 and the O2 sensor 7 into the lung 8. The
pressure sensor 6 measures the airway pressure.

Any excess amount of the gas mixture flows into the anaesthetic gas
scavenging system 12 and13.
4803

Fig. 23 Spontaneous breathing, inspiration

7.6 Spontaneous breathing: Expiration


The item numbers mentioned in the following paragraphs refer to Fig. 24.

During expiration, the inspiratory valve 4 remains closed thus preventing the
expiratory gas from flowing back into the inspiratory branch.

The APL valve 10 is open. The expiratory gas flows from the lung 5 through
No.3103_0000001949

the flow sensor 6, the PEEP control valve 7, the expiratory valve 8 and the
semi-open adapter 12. At the same time, new fresh gas 2 flows into the
manual breathing bag 1.

40 Fabius plus Technical Documentation IPM


Function descriptions pneumatic assembly
Semi-open adapter

When the manual breathing bag is full, any excess gas mixture flows through
the semi-open adapter 12 into the anaesthetic gas scavenging system 11.

4804

Fig. 24 Spontaneous breathing, expiration


No.3103_0000001949

Technical Documentation IPM Fabius plus 41


Function descriptions pneumatic assembly
Wall-mounted unit

8 Wall-mounted unit

The wall version of the Fabius does not include the trolley.

Fabius is mounted on a carrier plate. The carrier plate is attached by a


dovetail to a wall bracket.

An earthing cable and earthing pin provide the potential equalization.

8.1 Introduction
The illustrations accompanying this description are generic depictions.

The following describes the rotation function of the wall-mounted unit.

8.2 Rotation function


5482

Fig. 25 Position of locking lever on rear of unit. The colour do not


correspond to the original colour of Fabius plus XL.

1 To enable the unit to be rotated, turn the locking lever on the rear of the
unit 180° clockwise.
2 Rotate the unit left or right as desired, but not by more than 90°.
3 Make sure no cable or tubing is squeezed in the process.
Fabius can be used when set to the desired position.
4 On completing work, rotate Fabius back to its home position.
No.3103_0000001949

42 Fabius plus Technical Documentation IPM


Function descriptions pneumatic assembly
Wall-mounted unit

5 Turn the locking lever 180° anti-clockwise.

5480

Fig. 26 Lock catch recess (1)

6 Make sure the lock catch is engaged.

The unit is secure in this position.


No.3103_0000001949

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No.3103_0000001949

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Function descriptions - Electronics

This chapter contains descriptions of the device's technical functions.

1 Control PCB.............................................................................................................................. 46
2 Electrical block diagram............................................................................................................ 47
3 Control unit ............................................................................................................................... 48
4 Battery backup.......................................................................................................................... 50
5 FiO2 measurement ................................................................................................................... 51
6 Respiratory Flow Measurement................................................................................................ 53
No.3103_0000001949

Technical Documentation IPM Fabius plus 45


Function descriptions - Electronics
Control PCB

1 Control PCB

The Control PCB contains the following functions:


– Motor control and monitoring
– Measurement of O2 and flow parameters
– Provision of one or two serial interfaces
– Evaluation of the O2 low signal
– PEEP valve control
– Pump control
– Front panel display control
– Evaluation of keypad and rotary encoder
– The required supply voltages are supplied by the power supply unit.
4225

Fig. 27 Controller functional block diagram


No.3103_0000001949

46 Fabius plus Technical Documentation IPM


Function descriptions - Electronics
Electrical block diagram

2 Electrical block diagram

8038

Fig. 28 Electrical block diagram


No.3103_0000001949

Technical Documentation IPM Fabius plus 47


Function descriptions - Electronics
Control unit

3 Control unit

The control panel comprises a graphical display, a membrane keypad, a


rotary encoder and a loudspeaker.

Data and power for the display comes from the Control PCB via a 20-
conductor ribbon cable. The keypad interface is connected to the Control
PCB by a 30-conductor ribbon cable. A block diagram of the control panel
assembly is shown in the following illustration.
5527

Fig. 29 Control panel block diagram


5526

Fig. 30 Fabius control unit ( "Standby" screen shown)

Item Function
1 Selects volume controlled ventilation mode

Refer to instructions for use


2 Selects pressure controlled ventilation mode

Refer to instructions for use


No.3103_0000001949

3 Pressure Support option


4 SIMV option

48 Fabius plus Technical Documentation IPM


Function descriptions - Electronics
Control unit

Item Function
5 Switches the ventilator to MAN/SPONT mode

Refer to instructions for use


6 Programmable keys: Activate the corresponding function that
appears on screen above the key
7 For setting alarm limits

Refer to instructions for use


8 Setup key: Activates sub-screens for monitoring functions.

Refer to instructions for use


9 Home key: Returns display to main screen shown before standby
10 Rotary encoder: Moves the cursor on the screen; confirms selection
when pressed
11 Alarm status indicators:

Flashing red: Warning; flashing yellow: Caution; solid yellow: Note


12 Alarm silence key: Silences all active alarms for two minutes
13 Alarm LED: Is illuminated to indicate a low O2 pipeline supply.
14 Power ON indicator: Lighted when device is plugged into an active
mains outlet
15 Switches the unit back to standby mode
No.3103_0000001949

Technical Documentation IPM Fabius plus 49


Function descriptions - Electronics
Battery backup

4 Battery backup

The Fabius backup power is provided by two series-connected, 12-V


rechargeable batteries. These batteries remain on charge as long as the
device is connected to a live mains supply. Should power supply fail while the
device is in operation, the batteries will allow the device to continue operating
for a minimum of 45 minutes, provided that the batteries are fully charged.

The batteries are located inside the control box. The 3.15 A battery fuse is
located at the rear of the control box.
4131

Fig. 31 Battery backup arrangement

No.3103_0000001949

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Function descriptions - Electronics
FiO2 measurement

5 FiO2 measurement

The O2 sensor measures the O2 concentration in the respiratory gas (FiO2).

The O2 sensor contains a capsule with alkaline electrolyte, a lead anode, two
gold cathodes, and a Teflon membrane. The spatial separation of the two
gold cathodes allows to carry out a voltage comparison.

The O2 sensor is an electrochemical cell that generates a voltage from the


ion current.
4228

Fig. 32 O2 sensor

Item Designation
1 Teflon membrane
2 Gold cathode A
3 Lead anode
4 Temperature compensation resistors
5 Alkaline electrolyte
6 Gold cathode B

The O2 to be measured diffuses through the Teflon membrane, undergoes a


chemical reaction at the gold cathodes (negative) and produces lead oxide
and water at the lead anode (positive). During this chemical process, a
voltage is generated that is proportional to the O2 partial pressure.

The internal resistance of the cell is determined by the surface of the gold
cathodes, the O2 diffusion velocity, and the distance between the gold
cathodes and the lead anode. This resistance is approximately 700 ohms.

The chemical process is temperature-sensitive. Therefore, compensation


resistors are connected in parallel to the O2 sensor. These resistors and the
internal resistor of the O2 sensor correct the measuring voltage. Since two
No.3103_0000001949

cathodes are used in the O2 sensor cell, two different voltages are generated.
These voltages are compared with each other. If their difference exceeds a
certain value, the device prompts the operator to check the cell.

Technical Documentation IPM Fabius plus 51


Function descriptions - Electronics
FiO2 measurement

If the O2 sensor fails, the control box will indicate an error on the graphics
display.

No.3103_0000001949

52 Fabius plus Technical Documentation IPM


Function descriptions - Electronics
Respiratory Flow Measurement

6 Respiratory Flow Measurement

The flow sensor functions according to the constant temperature hot-wire


anemometer principle. Respiratory gas flows past a thin platinum wire. This
platinum wire (Fig. 33/A) is located in a measuring tube and is electrically
heated. The platinum wire is held at a constant temperature. Gas flow
removes heat from the hot wire. The higher the gas flow rate, the greater the
heat removal. The amount of electrical current needed to maintain a constant
platinum wire temperature is thus proportional to the gas flow rate.

A second platinum wire (Fig. 33/B) in the measuring tube is used to


compensate for interference from different gases present in the respiratory
gas. The heat removed from the second platinum wire is measured during
inspiration when the gas flow is zero.

The different gases present in the respiratory gas have a different thermal
conductivity. The amount of heat removed from the second platinum wire is
thus an indicator of respiratory gas composition.

Internal calibration tables for O2/N2O mixtures, Air and 100% O2 are used to
linearize the measured flow.
4229

Fig. 33 Respiratory flow sensor

Item Designation
"A" Platinum wire "A"
"B" Platinum wire "B"
No.3103_0000001949

Technical Documentation IPM Fabius plus 53


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No.3103_0000001949

54 Fabius plus Technical Documentation IPM


Parts catalog and test instructions

Parts catalog

This chapter contains a list of the device's orderable parts.

Test Instructions

This chapter contains the measures required to determine the actual


condition of the device.

1 Parts catalog............................................................................................................................. 56
2 Test Instructions / Service Card IPM ........................................................................................ 115
3 Result Sheet Test instructions / Service Card IPM................................................................... 166
No.3103_0000001949

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Warning
Revision 3.0
All servicing and/or test procedures on the 9500840
device require detailed knowledge of this docu-
mentation. Use of the device requires detailed
knowledge and observance of the relevant
Instructions for Use.
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Table of contents

Table of contents

Important notes 5
1 Device configuration 5
1.1 Basic device configuration ....................................................................................................... 5
1.1.1 Serial number / software (if not otherwise recorded) ................................................. 5
2 Maintenance parts 6
2.1 Maintenance intervals, overview.............................................................................................. 6
2.2 Maintenance parts by specified interval................................................................................... 7
2.2.1 Lithium battery (every 3 years) .................................................................................. 7
2.2.2 Lead-gel battery (3-yearly)......................................................................................... 7
2.2.3 Input pressure regulator test (every 3 years)............................................................. 8
2.2.3.1 Downstream pressure of pipeline supply O2 input pressure regulator.................. 8
2.2.3.2 Downstream pressure of pipeline supply N2O input pressure regulator (not appli- 9
cable in nitrous-oxide-free mode) ..............................................................................
2.2.4 Drägersorb CLIC option............................................................................................. 9
2.2.4.1 Drägersorb Clic option (old, yearly) ....................................................................... 9
2.2.4.2 Drägersorb Clic option (new, yearly) ..................................................................... 10
2.2.4.3 Drägersorb Clic option (old, every 2 years) ........................................................... 10
2.2.4.4 Drägersorb Clic option (new, every 2 years) ......................................................... 10
2.2.4.5 Drägersorb Clic option (every 4 years).................................................................. 10
2.2.5 Pin index option (every 6 years) ................................................................................ 10
3 Electrical safety 12
3.1 Electrical safety, base unit, to DIN EN 62353 (IEC 62353) ...................................................... 12
3.1.1 Visual check............................................................................................................... 12
3.1.2 Protective earth resistance ........................................................................................ 13
3.1.3 Protective earth resistance measuring points............................................................ 14
3.1.4 Equipment leakage current........................................................................................ 14
3.2 Option: Electrical safety, COSY2 heater power supply unit, to DIN EN 62353 (IEC 62353).... 16
3.2.1 Visual check............................................................................................................... 16
3.2.2 Protective earth resistance ........................................................................................ 16
3.2.3 Protective earth resistance measuring points............................................................ 17
3.2.4 Equipment leakage current........................................................................................ 17
3.3 Electrical safety according to IEC 60601-1 .............................................................................. 19
3.3.1 Base unit.................................................................................................................... 19
3.3.2 Protective earth resistance ........................................................................................ 19
3.3.3 Earth leakage current ................................................................................................ 20
3.3.4 Optional COSY2 heater power supply unit, protective earth conductor resistance ... 21
3.3.5 Optional COSY2 heater power supply unit, earth leakage current ............................ 21
4 Function and condition test 22
4.1 Base unit .................................................................................................................................. 22
4.1.1 Labels and instructions for use .................................................................................. 22
4.1.2 Condition and function of the base unit ..................................................................... 23
No.2301_0000007441

4.1.3 Tubing (PAE, PA, fabric-reinforced) ........................................................................... 23


4.1.4 Condition and function of vaporizer mount and interlock........................................... 23
4.2 Basic unit self-test, calibration and leakage test ...................................................................... 23
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4.2.1Self-test/system diagnostics of the base unit ............................................................ 23


4.2.2O2 sensor calibration (not applicable in case of monitoring with external O2 mea- 23
surement) ..................................................................................................................
4.2.3 Flow sensor calibration.............................................................................................. 25
4.2.4 Leak tightness of breathing system........................................................................... 25
4.2.5 Fresh gas leakage test passive (with and without vaporizer) .................................... 25
4.2.6 Nitrous oxide-free option: Fresh gas leakage passive test........................................ 26
4.3 Service data and basic unit calibration .................................................................................... 27
4.3.1 Service data .............................................................................................................. 27
4.3.2 Pressure .................................................................................................................... 28
4.3.3 Pump calibration and vacuum test ............................................................................ 28
4.3.4 PEEP calibration ....................................................................................................... 29
4.3.5 O2 offset (not applicable to external O2 measurement)............................................ 29
4.4 Power failure, O2 sensor, flow sensor alarms ......................................................................... 30
4.4.1 Power failure alarm, battery circuit ............................................................................ 30
4.4.2 O2 low alarm ............................................................................................................. 30
4.4.3 Flow sensor failure alarm .......................................................................................... 30
4.4.4 O2 sensor failure alarm (not applicable in case of monitoring with external O2 mea- 31
surement) ..................................................................................................................
4.5 Flowmeter test ......................................................................................................................... 31
4.5.1 Comparative flow measurement with external flowmeter block ................................ 31
4.5.2 Safety valve of flowmeter block................................................................................. 31
4.6 SORC test (not applicable in nitrous oxide-free mode) ........................................................... 31
4.6.1 N2O shut-off (not applicable in nitrous oxide-free mode) .......................................... 32
4.6.2 O2 concentration and gas type test (not applicable in nitrous oxide-free mode) ...... 32
4.6.3 SORC function (not applicable in nitrous oxide-free mode) ...................................... 34
4.7 Additional tests......................................................................................................................... 34
4.7.1 Pressure-limiting valve and auxiliary-air valve .......................................................... 35
4.7.2 Pmax accuracy.......................................................................................................... 36
4.8 Ventilation modes .................................................................................................................... 36
4.8.1 Manual ventilation ..................................................................................................... 36
4.8.2 Spontaneous breathing ............................................................................................. 36
4.8.3 Lung ventilator performance...................................................................................... 36
4.9 PEEP pressure accuracy......................................................................................................... 37
4.10 Optional pin index cylinder connections, manometers, and pressure regulators .................... 37
4.10.1 Cylinder connections, non-return valves, manometers ............................................. 38
4.10.2 Checking the pressure regulator option of the pin index cylinders ............................ 38
4.11 Optional high-pressure cylinders, high-pressure regulators .................................................... 40
4.11.1 High-pressure cylinders on the gas inlet block (non-return valves)........................... 40
4.11.2 O2 high-pressure leakage ......................................................................................... 41
4.11.3 N2O high-pressure leakage (not applicable in nitrous oxide-free mode) .................. 41
4.12 Final procedures ...................................................................................................................... 41
4.12.1 Test label and device handover ................................................................................. 42
No.2301_0000007441

5 Test equipment 42
5.1 Test equipment ........................................................................................................................ 42
5.1.1 Test equipment subject to mandatory calibration ...................................................... 42
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Table of contents

5.1.2 Test equipment not subject to mandatory calibration................................................. 44


6 Annex 46
6.1 Form for customer settings in service mode ............................................................................ 47
6.2 Ambient pressure ..................................................................................................................... 49

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Device configuration

Important notes

NOTE
Prior to using these test instructions, check that they are the latest revision
(compare revision with latest service documentation).
All results and inputs can be documented in the "Test Report" or "Result
Sheet".

NOTE
Do not use these test instructions for testing after a repair.

NOTE
If the "nitrous-oxide-free anaesthesia" upgrade kit is available, no nitrous
oxide-related tests are required.

For the devices listed below, the test instructions specific to the relevant
device must be used:
– Vapor 19.n
– Vapor 2000
– Vapor 3000
– Devapor
– Connected monitoring
– Silverline pressure regulator
Conversions: 1 bar = 14.504 psi; 1 mbar = 1.01973 cmH2O.

1 Device configuration

This section records the device configuration.

1.1 Basic device configuration

1.1.1 Serial number / software (if not otherwise recorded)

NOTE
The serial number is located on the rear of the device.

Result Device serial number


[________txt]
No.2301_0000007441

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Maintenance parts

NOTE
The serial number is located on the side of the breathing system.

Result Serial number of the breathing system (COSY2)


[________txt]

Result Serial number of optional bronchial suction device


[________txt]

Result Optional external monitoring device


[________txt]

2 Maintenance parts

This chapter contains interval-related maintenance parts, measures, and


tests that can only be performed on an open device.

2.1 Maintenance intervals, overview

NOTE
Drägersorb option: New devices use the Drägersorb Clic adapter (MX50090)
instead of older adapters for which the seal set has to be changed separately
at short intervals.
The Drägersorb Clic adapter (MX50090) is only replaced every four years,
and then completely.

NOTE
Pin index option: The upgrade kit for the pressure regulator is replaced
depending on the connection variant.

The following table presents an overview of the required sets, maintenance


parts and intermittent activities over 12 years. After 12 years the table is
worked through again starting with the first year.

Designation Part num- 1 2 3 4 5 6 7 8 9 10 11 12


ber
Lead-gel battery 1841416 x x x x
Lithium battery 1866249 x x x x
Tests
O2 input pressure regu- -
lator downstream pres- x x x x
sure test
N2O input pressure reg- -
No.2301_0000007441

ulator downstream pres- x x x x


sure test
Drägersorb CLIC option
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Maintenance parts

Designation Part num- 1 2 3 4 5 6 7 8 9 10 11 12


ber
Drägersorb Clic option MX08000
(old), seal set for x x x x x x
adapter (yearly)
Drägersorb Clic option M36045
(new), seal set for x x x x x x
adapter (yearly)
Drägersorb Clic option MX08001
(old), seal set for x x x x x x
adapter (every 2 years)
Drägersorb Clic option MX35381
(new), seal set for x x x x x x
adapter (every 2 years)
Drägersorb Clic option, MX50090
x x x
adapter (every 4 years)
Pin index option. Replace one of the following pressure regulators:
Upgrade kit, N2O pres- 8608799
x x
sure regulator, long
Upgrade kit, N2O pres- 8608800
x x
sure regulator, short
Upgrade kit, O2 pres- 8608804
x x
sure regulator, short T
Upgrade kit, O2/Air pres- 8608801
x x
sure regulator, long L
Upgrade kit, O2/Air pres- 8608803
x x
sure regulator, short L

2.2 Maintenance parts by specified interval

2.2.1 Lithium battery (every 3 years)

NOTE
Batteries are special waste. Dispose of batteries in accordance with local
waste disposal regulations.

Quan- Designation Number Location/Remark


tity
1 Lithium battery 1866249 On the Control PCB
Result Lithium battery
Next replacement: [________dat]

2.2.2 Lead-gel battery (3-yearly)

NOTE
No.2301_0000007441

Batteries are special waste. Dispose of batteries in accordance with local


waste disposal regulations.
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Maintenance parts

Quan- Designation Number Location/Remark


tity
2 12-V battery 1841416 In control box
Result Lead-gel battery
Next replacement: [________dat]

2.2.3 Input pressure regulator test (every 3 years)


Prerequisites The pressure regulators are freely accessible.

2.2.3.1 Downstream pressure of pipeline supply O2 input pressure regulator

Test set-up

2475

Fig. 1 Input pressure regulator test setup

Item Designation
1 N2O outlet (to the N2O flow-control valve)
2 Gas inlet assembly
3 N2O input pressure regulator
4 O2 input pressure regulator
5 O2 outlet (to the O2 flow-control valve)
6 T-connector (7901458)
7 To O2 flow control valve
8 To N2O flow control valve
9 Digital manometer (7910724)
Action • Relieve all cylinder and pipeline supply pressures.
• Disconnect all cylinders and pipeline supply tubes.
• Prepare the test setup for the O2 input pressure regulator (see Fig. 1).
• Connect the O2 pipeline supply to the gas inlet assembly.
No.2301_0000007441

• Set the O2 flow at the flow control valve to 2.5 L/min.


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Maintenance parts

Test The O2 pressure regulator output pressure is 2.2 to 2.6 bar.


Result O2 pipeline supply inlet pressure regulator downstream pressure, every
3 years
[________OK]

Result Next test


[________dat]

Action • Relieve the O2 pressure from the pipeline supply.


• Close the O2 flow control valve and detach the O2 pipeline supply tube
from the gas inlet assembly.
• Remove the test setup.
• Reconnect the O2 pressure tube leading from the O2 flow control valve to
the O2 connector on the inlet block.

2.2.3.2 Downstream pressure of pipeline supply N2O input pressure regulator (not appli-
cable in nitrous-oxide-free mode)

Action • Remove the N2O pressure tube from the N2O outlet of the gas inlet block
and interconnect the digital manometer. Refer to the previous illustration.
• Reconnect the O2 and N2O pipeline tube to the pipeline supply inlet ports
and activate the pipeline supplies.
• Set the O2 and N2O flows at the flow control valves to 2.5 L/min.
Test The N2O pressure regulator output pressure is 2.2 to 2.6 bar.
Result N2O pipeline supply input pressure regulator downstream pressure (not
applicable in nitrous-oxide-free mode)
[________OK]

Result Next test


[________dat]

Action • Relieve the O2 and N2O pipeline pressures.


• Close the O2 and N2O flow control valves and disconnect both pipeline
supply tubes from the inlet block.
• Remove test setup.
• Reconnect the N2O pressure tube leading from the N2O flow control valve
to the N2O connector on the inlet block.

2.2.4 Drägersorb CLIC option

2.2.4.1 Drägersorb Clic option (old, yearly)

Quan- Designation Number Location/Remark


tity
1 Set of seals MX08000 Old adapter version, rating
plate glued on, up to ARTN-
No.2301_0000007441

XXXX

Result Set of seals


Next replacement: [________dat]
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Maintenance parts

2.2.4.2 Drägersorb Clic option (new, yearly)

Quan- Designation Number Location/Remark


tity
1 Set of seals M36045 New adapter version, rating
plate lasered
Result Set of seals
Next replacement: [________dat]

2.2.4.3 Drägersorb Clic option (old, every 2 years)

Quan- Designation Number Location/Remark


tity
1 Set of seals MX08001 Old adapter version, rating
plate printed
Result Set of seals
Next replacement: [________dat]

2.2.4.4 Drägersorb Clic option (new, every 2 years)

Quan- Designation Number Location/Remark


tity
1 Set of seals M35381 New adapter version, rating
plate lasered
Result Set of seals
Next replacement: [________dat]

2.2.4.5 Drägersorb Clic option (every 4 years)

Quantity Designation Number Location/Remark


1 Drägersorb CLIC MX50090 Breathing system
Result Drägersorb CLIC
Next replacement: [________dat]

2.2.5 Pin index option (every 6 years)

The service set is installed as a pre-assembled upgrade kit. The available


upgrade kits differ in the following points:
– Whether the pressure regulator is used for N2O, O2 or Air.
– Whether the pressure regulator has a T or L connection.
No.2301_0000007441

– Whether the non-return valve is short or long.


Select the relevant upgrade kit according to these options.
Prerequisites The pressure regulators are freely accessible.
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Maintenance parts

Replace the N2O pressure regulator with the long non-return valve:

Quan- Designation Number Location/Remark


tity
1 Upgrade kit, N2O 8608799 On cylinder connection
pressure regulator,
long
Result Option: Upgrade kit, N2O pressure regulator, long
Next replacement: [________dat]

Replacing the N2O pressure regulator with the short non-return valve:

Quan- Designation Number Location/Remark


tity
1 Upgrade kit, N2O 8608800 On cylinder connection
pressure regulator,
short
Result Option: Upgrade kit, N2O pressure regulator, short
Next replacement: [________dat]

Replace the O2 pressure regulator with the short non-return valve and the T
connection.

Quan- Designation Number Location/Remark


tity
1 Upgrade kit, O2 pres- 8608804 On cylinder connection
sure regulator, short
T
Result Option: Upgrade kit, O2 pressure regulator, short T
Next replacement: [________dat]

Replace the O2/Air pressure regulator with the long non-return valve and L
connection:

Quan- Designation Number Location/Remark


tity
1 Upgrade kit, O2/Air 8608801 On cylinder connection
pressure regulator,
long L
Result Option: Upgrade kit, O2/Air pressure regulator, long L
Next replacement: [________dat]

Replace the O2/Air pressure regulator with the short non-return valve and L
connection:
No.2301_0000007441

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Electrical safety

Quan- Designation Number Location/Remark


tity
1 Upgrade kit, O2/Air 8608803 On cylinder connection
pressure regulator,
short L

Result Option: Upgrade kit, O2/Air pressure regulator, short L


Next replacement: [________dat]

3 Electrical safety

This section contains tests which have to be performed in order to determine


the operational readiness of the medical-electrical system.

3.1 Electrical safety, base unit, to DIN EN 62353 (IEC 62353)

NOTE
The device conforms to the conditions of protection class I, type BF.

Notes
The following subsections provide descriptions of device checks, recurrent
testing and testing after servicing of medical electrical (ME) devices.

NOTE
The tester, e.g. SECUTEST, must be correctly configured for all measure-
ments. If implausible measurement results are obtained, such as a leakage
current of 0.0 —A, check the tester configuration in addition to the test setup!

NOTE
In testing to IEC 62353, the medical electrical device (ME device) or the med-
ical electrical system (ME system) must be tested.
ME systems must be treated like ME devices.
An ME system is a combination of several devices, as specified by the manu-
facturer, of which at least one must be an ME device, which are intercon-
nected by a functional connection or by means of a multiple socket outlet.

NOTE
In the case of devices connected to other devices by a data cable, this con-
nection must be disconnected prior to performing the electrical safety test, in
order to avoid false measurements.
No.2301_0000007441

3.1.1 Visual check


Prerequisites The tester and the device under test are switched off.
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Electrical safety

Action
WARNING
Hazardous voltage
Touching live components can lead to serious injury or death.
Ź Before checking the power fuse links, disconnect the mains plug from the
socket-outlet.

• Disconnect the mains plug from the socket-outlet.


Test The power fuse-links of the device under test match the specifications on the
rating plate.
The power supply cord and the mains plug are not dirty or damaged.
Result Condition checked
[________OK]

3.1.2 Protective earth resistance


Test set-up
1936

Fig. 2 Protective conductor resistance

Item Designation
1 Tester
2 Device under test
3 Tester probe cable
L Conductor
N Neutral conductor
PE Protective earth conductor
Action • Prepare the test setup.
• Switch the tester on.
• Configure the tester appropriately and follow the instructions on the tester.
• Using the tip of the probe cable, scan each of the points on the device
under test listed under Protective earth resistance measuring points one
after the other, moving the mains power cable along the entire length
during the measurement. The resistance must not change when you do so.
Test The protective conductor resistance of devices with detachable but con-
nected mains power cables must not exceed 0.3 Ohm in each case.
No.2301_0000007441

Result Maximum measured value of device with power cable.


[________ȍ]
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Electrical safety

Test If other optional power cables are fitted, the respective protective conductor
resistance must not exceed 0.1 Ohms. Move the power cable along the entire
length during the measurement. The resistance must not change when you
do so.
Result Maximum measured value of optional power cable.
[________ȍ]

or
Test The protective conductor resistance of ME systems (including mains power
cable) must not exceed 0.5 Ohm in each case.
Result Maximum measured value of ME system.
[________ȍ]

3.1.3 Protective earth resistance measuring points


Action • Scan the following measuring points for protective earth resistance mea-
surement one after the other using the tip of the probe cable:
– Potential equalization pin on control box rear panel
– Potential equalization pins on auxiliary sockets
– Protective earth contacts on auxiliary sockets
– Screws on O2 inlet block
– Pin index connection (if fitted)
– Potential equalization pin in ventilator interior
– Screws on control box rear panel
– Vapor plug-in system
– Screws on control box rail
Result Measurement points scanned.
[________OK]

3.1.4 Equipment leakage current

NOTE
The device leakage current can be tested by the differential measurement
method or the direct measurement method.
In direct measurement, set up the device under test with insulation and scan
all touchable conductive components using the probe (the protective conduc-
tor is internally interrupted in the tester).

Prerequisites The tester is switched on.


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Electrical safety

Test set-up

1932
Fig. 3 Device leakage current

Item Designation
1 Tester
2 Device under test
3 (applied part) Device-specific test adapter for tester
4 (applied part) Configurable sockets for applied parts
L Conductor
N Neutral conductor
PE Protective earth conductor
Action • Prepare the test setup.
• (applied part) Connect the device-specific test adapter on one end to the
device under test and on the other end to the tester's configurable socket
"A" for applied parts (paying attention to the configuration!).
• Follow the instructions on the tester.

NOTE
The test must be performed twice! The second test is performed with the plug
rotated 180° in the socket. In many test devices the mains plug rotation is
simulated by means of a built-in selector switch. The higher measured value
must be documented.

NOTE
The reference value (initial measured value) must always be transmitted!

NOTE
If the measured values are between 90% and 100% of the permissible limit
value, the reference value and the previously measured values of the recur-
rent test should be applied to assess electrical safety!

Test The reference value must not exceed 500 —A.


Result Reference value
[________—A]

Test The recurrent measurement value must not exceed 500 —A.
No.2301_0000007441

Result Recurrent measurement


[________—A]
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Electrical safety

3.2 Option: Electrical safety, COSY2 heater power supply unit, to DIN EN
62353 (IEC 62353)

NOTE
The device conforms to the conditions of protection class I, type B.

3.2.1 Visual check


Prerequisites The tester and the device under test are switched off.
Action
WARNING
Hazardous voltage.
Touching live components can lead to serious injury or death.
Ź Disconnect the power cable from the socket before testing the power fuse-
links.

• Disconnect the power plug from the mains socket.


Test The power fuse-links of the device under test match the specifications on the
rating plate.
The power cable and plug are not dirty or damaged.
Result Condition checked
[________OK]

3.2.2 Protective earth resistance


Test set-up
1936

Fig. 4 Protective conductor resistance

Item Designation
1 Tester
2 Device under test
3 Tester probe cable
L Conductor
No.2301_0000007441

N Neutral conductor
PE Protective earth conductor
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Electrical safety

Action • Prepare the test setup.


• Switch the tester on.
• Configure the tester appropriately and follow the instructions on the tester.
• Using the tip of the probe cable, scan each of the points on the device
under test listed under Protective earth resistance measuring points one
after the other, moving the mains power cable along the entire length
during the measurement. The resistance must not change when you do so.
Test The protective conductor resistance of devices with detachable but con-
nected mains power cables must not exceed 0.3 Ohm in each case.
Result Maximum measured value of device with power cable.
[________ȍ]

or
Test The protective conductor resistance of ME systems (including mains power
cable) must not exceed 0.5 Ohm in each case.
Result Maximum measured value of ME system.
[________ȍ]

3.2.3 Protective earth resistance measuring points


Action • Touch the following protective conductor resistance measuring points one
after the other with the tip of the test probe:
– Screw heads at the power supply unit housing
Result Measuring points touched.
[________OK]

3.2.4 Equipment leakage current

NOTE
The device leakage current can be tested by the differential measurement
method or the direct measurement method.
In direct measurement, set up the device under test with insulation and scan
all touchable conductive components using the probe (the protective conduc-
tor is internally interrupted in the tester).

Prerequisites The tester is switched on.


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Electrical safety

Test set-up

1932
Fig. 5 Device leakage current

Item Designation
1 Tester
2 Device under test
3 (applied part) Device-specific test adapter for tester
4 (applied part) Configurable sockets for applied parts
L Conductor
N Neutral conductor
PE Protective earth conductor
Action • Prepare the test setup.
• (applied part) Connect the device-specific test adapter on one end to the
device under test and on the other end to the tester's configurable socket
"A" for applied parts (paying attention to the configuration!).
• Follow the instructions on the tester.

NOTE
The test must be performed twice! The second test is performed with the plug
rotated 180° in the socket. In many test devices the mains plug rotation is
simulated by means of a built-in selector switch. The higher measured value
must be documented.

NOTE
The reference value (initial measured value) must always be transmitted!

NOTE
If the measured values are between 90% and 100% of the permissible limit
value, the reference value and the previously measured values of the recur-
rent test should be applied to assess electrical safety!

Test The reference value must not exceed 500 —A.


Result Reference value
[________—A]

Test The recurrent measurement value must not exceed 500 —A.
No.2301_0000007441

Result Recurrent measurement


[________—A]
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Electrical safety

3.3 Electrical safety according to IEC 60601-1


Introduction
NOTE
The Fabius conforms to the requirements of protection class I, type BF
The test to UL2601-1 is satisfied by testing to IEC 60601-1.
Differing limit values are marked.
Fabius is to be tested as a medical system with connected devices and addi-
tional sockets.

NOTE
The following tests are based on testing with the SECUTEST tester. This tes-
ter allows simulation of the power plug rotation. With other testers, it may be
necessary to rotate it manually (the higher measured value shall be docu-
mented).
In the case of devices connected to other devices by a data cable, this con-
nection must be disconnected prior to performing the electrical safety test, in
order to avoid false measurements.

3.3.1 Base unit


Action • Check the power fuse-links, plug for non-heating apparatus, power cable,
auxiliary sockets and potential equalization pin.
Test The power fuse-links match the specifications on the rating plate. The plug for
non-heating apparatus, power cable and potential equalization pin are neither
dirty nor damaged.
Result Base unit
[________OK]

3.3.2 Protective earth resistance


Test set-up
1629

Fig. 6 Test setup for the protective earth conductor


No.2301_0000007441

Item Designation
1 Tester, e.g. SECUTEST, 7910594
2 Fabius under test
No.3103_0000001949

3 Test probe with tip (e.g. SECUTEST accessories)

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Electrical safety

L Conductor
N Neutral conductor
PE (Protective earth) conductor
Action • Prepare the test setup.
• Switch on the SECUTEST and the Fabius.
• Using the tip of the test probe, scan each of the following points on the
Fabius one after the other:
– Screws on O2 inlet block
– Pin index connection (if fitted)
– Potential equalization pin on power supply unit
– Potential equalization pins on auxiliary sockets
– Protective earth contacts on auxiliary sockets
– Potential equalization pin in ventilator interior
– Screws on control box rear panel
– Vapor plug-in system
– Screws on control box rail
Test The protective earth resistance must not exceed 0.2 Ohm (including mains
power cable) in each case.
Result Protective earth resistance
[________ȍ]

3.3.3 Earth leakage current


Test set-up
NOTE
Set up the Fabius so that it is insulated.
1631

Fig. 7 Earth leakage current test setup

Item Designation
1 Tester, e.g. SECUTEST, 7910594
2 Fabius under test
No.2301_0000007441

L Conductor
N Neutral conductor
PE (Protective earth) conductor
No.3103_0000001949

Action • Prepare the test setup.

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Electrical safety

Test In normal condition (N.C.), the value must not exceed 500 —A.
Result Normal condition (N.C.)
[________—A]

Test In single fault condition (S.F.C.), the value must not exceed 1000 —A.
Result Single fault condition (S.F.C.)
[________—A]

Action • Switch off the SECUTEST and the Fabius.

3.3.4 Optional COSY2 heater power supply unit, protective earth conductor resistance
Test set-up

1629
Fig. 8 Test setup for the protective earth conductor

Item Designation
1 Tester, e.g. SECUTEST, 7910594
2 Heater power supply unit under test
3 Test probe with tip (e.g. SECUTEST accessories)
L Conductor
N Neutral conductor
PE (Protective earth) conductor
Action • Prepare the test setup.
• Switch on the SECUTEST and the heater.
• Using the tip of the test probe, scan the screw heads on the power supply
unit housing.
Test The protective earth resistance must not exceed 0.2 Ohm (including mains
power cable) in each case.
Result Protective earth resistance
[________ȍ]

3.3.5 Optional COSY2 heater power supply unit, earth leakage current
Test set-up
NOTE
No.2301_0000007441

Set up the Fabius so that it is insulated.


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Function and condition test

1631
Fig. 9 Earth leakage current test setup

Item Designation
1 Tester, e.g. SECUTEST, 7910594
2 Heater power supply unit under test
L Conductor
N Neutral conductor
PE (Protective earth) conductor
Action • Prepare the test setup.
Test In normal condition (N.C.), the value must not exceed 500 —A.
Result Normal condition (N.C.)
[________—A]

Test In single fault condition (S.F.C.), the value must not exceed 1000 —A.
Result Single fault condition (S.F.C.)
[________—A]

Action • Switch off the SECUTEST and the heater power supply unit.

4 Function and condition test

This section contains tests to establish whether the device and the accesso-
ries used conform to the stipulations of the Instructions for Use in terms of
condition and function.

4.1 Base unit


Prerequisites The device is fully assembled.

4.1.1 Labels and instructions for use


Test The labels and letterings are complete and legible.
No.2301_0000007441

The instructions for use are available, according to the user/owner.


Result Condition checked.
[________OK]
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Function and condition test

4.1.2 Condition and function of the base unit


Test – Castors and brakes
– Wall/ceiling mounting (if fitted)
– Resutator bag
– COSY2 heater power supply unit (if present)
– Convenience socket-outlets (optional)
– Nitrous oxide-free option: N2O sealing plug secure
Result Condition and function of base unit checked.
[________OK]

4.1.3 Tubing (PAE, PA, fabric-reinforced)


Test Check tubing, tube fittings and colour coding for perfect condition.
Result Condition and function checked.
[________OK]

4.1.4 Condition and function of vaporizer mount and interlock


Test Vapor anesthetic vaporizer mount and interlock
Result Condition and function checked.
[________OK]

4.2 Basic unit self-test, calibration and leakage test


Prerequisites The device is connected to the mains voltage.
The device is connected to the pipeline supply system or the cylinders are
open.

4.2.1 Self-test/system diagnostics of the base unit


Action • Turn the device power switch to "ON".
Test Check that the Fabius completes the self-test and that all tests indicate
"pass".
Result Entering the software version.
[________txt]

Result Self-test successfully completed.


[________OK]

4.2.2 O2 sensor calibration (not applicable in case of monitoring with external O2 mea-
surement)
Action • After the self-test, the Fabius is in the "Standby" screen.
• Press the "O2 sensor calibr." key and follow the on-screen instructions.
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Test After calibration is completed, verify the "O2 sensor error" message has dis-
appeared and calibration was successful.
Result O2 sensor calibr.
[________OK]

Action • Press the "Home" key to return to the Standby screen.


Test set-up
NOTE
This avoids long time constants in the following calibration and saves O2:
– Use the front panel of an older Dräger sensor housing and adapter top
M27961 in place of the original O2 sensor housing.
– Use test adapter 7900138 to perform the measurements directly at the
fresh gas outlet instead of at the COSY2 (see illustration).

2551

Fig. 10 Test setup for O2 sensor calibration

Item Designation
1 O2 sensor
2 Adapter top M27961
3 Test adapter 7900138
4 Tube
5 Kuhn connector M28189
6 Fresh gas tube

Checking concentration at 100% O2


Action • Insert the O2 sensor into the COSY2.
• Set an O2 flow of 4 L/min. (Fabius switches to "Man/Spont" mode).
• Press and hold O2 Flush for 1 minute.
No.2301_0000007441

Test The O2 concentration is97 to 100% within 3 minutes.


Result O2 concentration
No.3103_0000001949

[________%]

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Action • Press the "Home" key to switch to the Standby screen.


• Reconnect the fresh-gas tube.

4.2.3 Flow sensor calibration


Action • Disconnect the expiratory tube from the breathing system.
• Press the "Flow sensor calibr." key and follow the on-screen instructions.
Test At completion of calibration verify "Flow Calibration Completed" message
appears.
Result Flow sensor calibration
[________OK]

Action • Press the "Home" key to return to the Standby screen.


Action • Reconnect the expiratory tube to the expiratory connection of the breathing
system.

4.2.4 Leak tightness of breathing system


Introduction
NOTE
With all subsequent measurements make sure the pressure in the COSY2
never exceeds 80 mbar. Otherwise, an optional manometer could be dam-
aged.

Action • Fully mount the breathing system's components.


• Open the Standby screen.
• Click the "Leak/Compl.Test" button on the Standby screen.
• Follow the on-screen instructions.
Test Leakage test successfully completed.
Result Leak tightness of breathing system
[________OK]

Action • "Home" key to return to the Standby screen.

4.2.5 Fresh gas leakage test passive (with and without vaporizer)

NOTE
Carry out this test once with the vaporizer fitted and once without vaporizer.
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Function and condition test

Test set-up

1407
Fig. 11 Fresh gas leakage, shown on Fabius GS by way of example

Item Designation
1 Digital manometer 7910722
2 Fresh gas tube
3 Kuhn connector M28189
Action • Connect the unit to the pipeline supply.
• Close any cylinders on the Fabius.
• Unscrew the fresh gas tube from the COSY2 breathing system or (if A-
cone option installed) from the A-cone.
• Close all flow control valves.
• Connect a Kuhn connector and a digital manometer to the fresh gas outlet.
Test No pressure is displayed on the digital manometer.
Result Leak test of flow control valves
[________OK]

Action • Remove the digital manometer.


• Set a flow rate of 0.10 L/min on the O2 flow valve. Connect the digital
manometer to the fresh gas tube.
Test If the leakage is less than 0.1 L/min, a pressure greater than 35 mbar can be
built up on the digital manometer.
Result Fresh gas leakage with vaporizer
[________OK]

Result Fresh gas leakage without Vapor.


[________OK]

4.2.6 Nitrous oxide-free option: Fresh gas leakage passive test

NOTE
Carry out this test without the Vapor connected.
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Function and condition test

Test set-up

1407
Fig. 12 Fresh gas leakage, shown on Fabius GS by way of example

Item Designation
1 Digital manometer 7910722
2 Fresh gas tube
3 Kuhn connector M28189
Action • The N2O flow control valve is fully open.
• Remove the digital manometer.
• Set a flow rate of 0.10 L/min on the O2 flow valve.
• Connect the digital manometer to the fresh gas tube.
Test If the leakage is less than 0.1 L/min, a pressure greater than 35 mbar can be
built up on the digital manometer.
Result Fresh gas leakage
[________OK]

Action • Close the N2O flow control valve.


• Connect the fresh gas tube to the breathing system (COSY2).

4.3 Service data and basic unit calibration


Prerequisites The device is connected to the mains power supply.
The device is connected to the pipeline supply system or the cylinders are
open, as applicable.
Fabius is switched on and in Standby mode.

4.3.1 Service data


Action • Press and hold the Home and Standby keys, and then press the rotary
knob to access the system service screen.
Result Read the last service date under "Last Service date", and enter it in the
test report.
[________dat]

Result Set the next due service date, and enter it in the test report.
[________dat]
No.2301_0000007441

Action • Use the rotary knob to navigate to the "Main Service Screen".
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4.3.2 Pressure
Action • Scroll to "Calibration" and confirm.
• Scroll to "Pressure" and confirm.
• Follow the on-screen instructions and perform the Zero calibration.

Remove pressure sample line and Disconnect the pressure measuring


ventilator hose from breathing sys- line and the ventilator tube from the
tem. Expose to air. breathing system. Expose to ambient
air.
Let current pressure value stabilize. Wait until the current pressure value
has stabilized.
Touch "Store Zero" key to enter the Press the "Store Zero" key to store
current values as the calibration zero. the current values as calibration zero.

• Reconnect pressure line and ventilator tube to breathing system.


Test "INVALID" does not display.
Result Zero calibration complete.
[________OK]

Action • Press the "Exit" key.


• Press the rotary knob to access the "Main Service Screen".

4.3.3 Pump calibration and vacuum test

NOTE
Before performing the pump calibration/test, a valid pressure calibration must
be performed.

Action • Scroll to "Service Log" and confirm.


• Scroll to "Real Time Value" and confirm.
• Connect a manometer (7910722) to the tube connection (large diameter)
APL valve of the breathing system.
Test The displayed pressure is between -180 and -220 mbar.
Action • If the values are not attained, press the "Pump Cal" key.
• If the values are still not attained, calibrate the pump and pump output
according to the repair instructions to Ppump 200 ± 10 mbar.
Test The displayed pressure is between -180 and -220 mbar.
Action • Release the ventilator cover.
Result The measured pump pressure rises to approximately ambient pressure.
[________OK]

Action • Close the ventilator cover again.


Test The displayed pressure is again between -180 and -220 mbar.
Result Vacuum test and pump calibration performed (key background white).
No.2301_0000007441

[________OK]

Action • Press the rotary knob to access the "Main Service Screen".
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Function and condition test

4.3.4 PEEP calibration

NOTE
Before performing the PEEP valve calibration, a valid pressure calibration
must be performed. Otherwise an "Inv pres. Cal" message will appear.
Use a short tube for the subsequent connection between the expiratory and
inspiratory valves.

Action • Scroll to "Calibration" and confirm.


• Scroll to "PEEP" and confirm.
• Follow the on-screen instructions to calibrate PEEP.

Attach breathing hose from expiratory Connect the expiratory valve and the
valve to inspiratory valve and remove inspiratory valve with the breathing
breathing bag. system tube, and remove the breath-
ing bag.
Touch "Calibrate" key. Press the "Calibrate" key.
At completion of calibration "Calibra- On completion of the calibration, the
tion" shall indicate Pass/Fail. readout must be "Calibrate""Pass" or
"Fail".
Test Verify "PEEP Calibration" indicates "pass".
Result PEEP valve calibration complete.
[________OK]

Action • Press the "Exit" key.


• Press the rotary knob to access the "Main Service Screen".
• Reconnect the tubes to the breathing system.

4.3.5 O2 offset (not applicable to external O2 measurement)


Action • Scroll to "O2" and confirm.
• Follow the on-screen instructions and perform the O2 zero calibration.

Remove O2 cell from housing. Remove the O2 cell from the housing.
Let current cell values stabilize. Wait for the values to stabilize.
Touch "Store Zero" key to enter the Press the "Store Zero" key to store
current values as the calibration zero. the current values as calibration zero.
Reinstall O2 cell in sensor housing Reinstall the O2 cell into the sensor
housing.
Test O2 zero calibration is complete, when values are displayed under "Stored
zero cell A/B" and no "INVALID" is displayed.
Result O2 zero calibration complete.
[________OK]

Action • Reassemble the O2 sensor housing, and then install the O2 sensor hous-
ing onto the inspiratory dome of the breathing system.
No.2301_0000007441

• Press the "Exit" key.


• Press the rotary knob to access the "Main Service Screen".
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4.4 Power failure, O2 sensor, flow sensor alarms


Prerequisites The device is switched on.

4.4.1 Power failure alarm, battery circuit


Action • Press the "Standby" key to access Standby mode.
• Press the "MAN/SPONT" key on the operator control unit and confirm the
displayed message using the rotary knob.
Test Disconnect the power plug to check that the "Power failure" message
appears, the indicator LED lights up and the acoustic alarm sounds within
one minute of disconnecting the power plug.
On the Standby screen, check the battery state of charge.
Connect the power plug and check that the "Power failure" message disap-
pears.
Result Power failure alarm, battery circuit
[________OK]

4.4.2 O2 low alarm

NOTE
Unless already selected, set "O2 whistle" to "Enable" under "Configure" in
service mode.

Action • Connect the O2 pipeline supply tube to the gas distributor 7901495.
• Set the O2 flow to 0.5 L/min.
• Open and close the O2 cylinder valve.
Test At an indicated pressure of 1.1 to 1.65 bar the alarm message "LOW O2
SUPPLY PRESSURE!!!" appears, an acoustic alarm sounds and the red
alarm LED comes on.
Result At which pressure does the message appear?
[________bar]

Action • Bleed the remaining O2 pressure from the system, and close the flow con-
trol valve.
• Remove the gas manifold from the device and reconnect the pipeline sup-
ply tubes.

NOTE
Reset "O2 whistle" to customer settings.

4.4.3 Flow sensor failure alarm


Action • Disconnect the flow-sensor cable from the breathing system.
Test The "FLOW SENSOR ERROR !" message appears and an audible alarm
No.2301_0000007441

sounds.
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Action • Connect the flow-sensor cable to the breathing system.


• Calibrate the flow sensor.
Result The "FLOW SENSOR ERROR !" message has disappeared.
[________OK]

4.4.4 O2 sensor failure alarm (not applicable in case of monitoring with external O2 mea-
surement)
Action • Disconnect the O2 sensor cable from the rear of the Fabius.
Test The "O2 SENSOR ERROR !" message appears and an audible alarm
sounds.
Make sure that the O2 sensor has stabilized in ambient air for several min-
utes.
Action • Re-attach the O2 sensor cable.
• Calibrate O2 sensor.
Result The "O2 SENSOR ERROR !" message has disappeared.
[________OK]

4.5 Flowmeter test


Prerequisites The device is switched on and in "Standby" mode.
The APL valve is set to "SPONT".

4.5.1 Comparative flow measurement with external flowmeter block


Action • Connect the flowmeter block (7901161) to the fresh gas outlet.
• Reference measurement of at least 3 flow values in a range between 50
mL/min and 3 L/min for O2/N2O and between 500 mL/min and 6 L/min for
Air.
Test The measured values (O2, AIR, N2O) are within a tolerance of +/-10%.
Result Tests within tolerances.
[________OK]

4.5.2 Safety valve of flowmeter block


Action • Connect the mixed gas socket to the +1 bar manometer (7910722).
• Disconnect the vaporizer.
• Close the N2O fine control valve.
• Use the O2 and Air fine control valve to set a flow of 15 L/min.
Test The safety valve opens at a pressure of less than less than/equal to
900 mbar.
Result Tests within tolerance.
[________OK]
No.2301_0000007441

4.6 SORC test (not applicable in nitrous oxide-free mode)


No.3103_0000001949

Introduction These instructions describe the SORC test.

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Function and condition test

Prerequisites The device is switched on and in "Man/Spont" ventilation mode.

4.6.1 N2O shut-off (not applicable in nitrous oxide-free mode)

Cylinder supply
Action • Open the O2 and N2O cylinder valves (if fitted).
• Set the O2 and N2O flow control valves to 4 L/min.
• Close the O2 cylinder valve (if fitted).
Test The N2O flow ceases when the O2 flow is stopped.

Pipeline supply
Action • Connect the O2 pipeline supply.
• Connect the N2O pipeline supply.
• Set the APL valve to "Spont".
• Set the O2 and N2O flow control valves to 4 L/min.
• Disconnect the O2 pipeline supply.
Test The N2O flow ceases when the O2 flow is stopped.
Action • Close the N2O flow control valve.
Result N2O shut-off (not applicable in nitrous oxide-free mode)
[________OK]

4.6.2 O2 concentration and gas type test (not applicable in nitrous oxide-free mode)
Prerequisites Fabius is in “Man/Spont” ventilation mode.
Test set-up
2551

Fig. 13 Test setup for O2 sensor calibration

Item Designation
No.2301_0000007441

1 O2 sensor
2 Adapter top M27961
3 Test adapter 7900138
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Item Designation
4 Tube
5 Kuhn connector M28189
6 Fresh gas tube
Action • Prepare the O2 sensor calibration test setup.
• Connect the Air pipeline supply.
• Set the Air flow control valve to 4 L/min.
Test Air pipeline supply manometer indicates pipeline pressure.
Action • Open the O2 and N2O flow control valves.
Test The O2 and N2O manometers indicate no pressure.
Result Air pipeline supply manometer indicates pipeline pressure
[________OK]

Test The O2 and N2O flow on the flowmeter block is equal to 0 L/min.
Result No O2 or N2O flow
[________OK]

Action • Disconnect the air pipeline.


• Connect the O2 pipeline supply.
• Set the O2 flow control valve to 4 L/min.
Test O2 pipeline supply manometer indicates pipeline pressure.
The air and N2O manometers indicate no pressure.
Result O2 pipeline supply manometer indicates pipeline pressure.
[________OK]

Test Air and N2O flow equal to 0 L/min.


Result No Air or N2O flow
[________OK]

Action • Connect the N2O pipeline supply (not applicable in nitrous-oxide-free


mode).
• Set the N2O flow control valve to 2 L/min.
Test The O2 concentration is 61 to 71 %.
If using Air instead of N2O, the O2 concentration 68 to 78 %.
Air manometer indicates no pressure.
Result O2 concentration
[________OK]

Test Air flow equal to 0 L/min.


Result No Air flow
[________OK]
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Function and condition test

4.6.3 SORC function (not applicable in nitrous oxide-free mode)


Action • Press the O2 Flush button for 5 seconds.
• Set the O2 and N2O flow control valves to maximum.
• Set the following flow values one after the other and check the O2 concen-
tration.
• Set the O2 flow control valve to 0.5 L/min.
• The N2O flow on the flowmeter block is 1 to 1.8 L/min.
• Set the O2 flow to 1 L/min.
• Set the O2 flow to 3 L/min.
Test The O2 concentration at each of the above value settings is 23% or higher.
Result O2 concentration
[________OK]

Action • Reduce the O2 flow to 0.5 L/min.


Test The N2O flow is greater than/equal to 0.6 L/min.
Result N2O flow
[________L/min]

Action • Reduce the O2 flow to zero.


Test The reading on the N2O flowmeter is equal to 0 L/min.
Action • Slowly increase the O2 flow until there is no more N2O flow left.
Test N2O starts flowing at an O2 flow of 0.13 to 0.27 L/min.
Result O2 flow
[________L/min]

Action • Close the O2 and N2O flow control valves.

4.7 Additional tests


Prerequisites The device is switched on, has successfully completed the self-test, and is in
"Standby" mode.
The breathing system is fitted.
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Function and condition test

4.7.1 Pressure-limiting valve and auxiliary-air valve


Test set-up

1438
Fig. 14 Test setup for the pressure-limiting valve

Item Designation
1 Test connector M13506
2 Digital manometer 7910722
Action • Set the following values:

Ventilation mode = IPPV(VC)


Pmax = 70 mbar
Vt = 1400 mL
Freq = 4 BPM
TI:TE = 1:1
TIP:TI = 0%
PEEP = 0 mbar (cmH2O)

• Confirm the setting with the rotary knob.


• Prepare the test setup.
Test The pressure-limiting valve opens between 70 and 80 mbar (cmH2O) when
the ventilator is in the inspiratory phase.
Test The auxiliary air valve opens between -6 and -10.0 mbar (cmH2O) when the
ventilator is in the expiratory phase.
Result The pressure-limiting valve and the auxiliary-air valve function properly.
[________OK]

Action • Remove test setup.


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Function and condition test

4.7.2 Pmax accuracy


Action • Set ventilation mode IPPV (VC).
• Connect a manometer (7910722) to the Y-piece.
Test Verify the test manometer readout and the airway pressure values for the fol-
lowing Pmax settings:

Pmax setting Displayed value (mbar)


25 20 to 30
70 65 to 75
Result Pmax accuracy
[________OK]

4.8 Ventilation modes


Prerequisites The device is switched on, has successfully completed the self-test, and is in
"Standby" mode.
The breathing system is fitted.

4.8.1 Manual ventilation


Action • Connect a test lung to the Y-piece of the breathing system.
• Select Man/Spont mode.
• Set the O2 fresh gas flow to 3 L/min.
• Set APL valve to MAN, 30 mbar.
Test Manual ventilation can be applied by squeezing the manual breathing bag.
Result Manual ventilation
[________OK]

4.8.2 Spontaneous breathing


Action • Set the APL valve to SPONT.
Test Spontaneous breathing with the connected test lung is possible.
Result Spontaneous breathing
[________OK]

Action • Close the O2 flow control valve.

4.8.3 Lung ventilator performance


Action • Switch to IPPV (VC) mode.
• Press the flush button briefly to inflate the bag.
• Adjust the following values:
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pmax = 70 mbar
Vt = 380 mL
Freq = 12 BPM
TI:TE = 1:1
TIP:TI = 10%
PEEP = 0 mbar

• Confirm settings with the rotary knob.


Test IPPV (VC) mode is indicated.
Ventilation starts.
The ventilator is running quietly and smoothly.
Result Ventilator is running quietly and smoothly
[________OK]

Test Volume delivery Vte 300 to 450 mL


Result Volume delivery
[________mL]

4.9 PEEP pressure accuracy


Action • After 10 breaths, press the PEEP parameter button, and then enter the
listed "PEEP setting" values.
Test Verify the displayed values for the following PEEP settings:

PEEP setting Displayed value (mbar)


0 0 to 2
5 3 to 7
15 12 to 18
Action • Return the PEEP setting to Zero and confirm.
Result PEEP pressure accuracy
[________OK]

4.10 Optional pin index cylinder connections, manometers, and pressure


regulators
Introduction These instructions describe the function and condition testing of the optional
pin index cylinder connectors, manometers and pressure regulators. The pin
index connectors are located on the rear of the Fabius.
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Function and condition test

4.10.1 Cylinder connections, non-return valves, manometers


Test – Handles on cylinder connection function smoothly.
– Pins on cylinder connection are in perfect condition.
– Cylinder seal is fitted on each cylinder connection assembly and is OK;
replace as necessary.
– Cylinder connection plug is fitted.
– Gas type label present.
– Cylinder wrench present.
Result Condition of cylinder connections checked.
[________OK]

Action • Set the device’s power switch to the OFF position.


• Disconnect all pipeline supply tubes.
• Connect a cylinder to each cylinder connection, and then open the cylinder
valve.
• Let the pressure stabilize, close the cylinder valve, and remove the cylin-
ders from the cylinder connection assembly.
Test The cylinder manometer on the front of the Fabius indicates the relevant cyl-
inder pressure as specified on the gas type label.
Result No leakage is detectable.
[________OK]

Action • Bleed all pressure from the cylinder circuits using the flow control valves.
Test The cylinder manometers indicate 0 bar/psi.
Result Function of non-return valve and manometer
[________OK]

Action • Connect the cylinders and open the valves one after the other.

4.10.2 Checking the pressure regulator option of the pin index cylinders
Test set-up
1411

Fig. 15 Pressure regulator test setup

Item Designation
1 Test cylinder
No.2301_0000007441

2 Test pressure regulator 7901482


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Function and condition test

Item Designation
3 Test adapter 7901495
4 Device inlet
5 O2 pipeline supply

O2 pressure regulator
Action • Prepare the pressure regulator test setup and connect the test adapter (3)
to the O2 pipeline supply connector at the device inlet (4).
• Set the pressure at the test pressure regulator (2) to 5 bar.
• Open the O2 pin index cylinder valve.
• Set the O2 flow valve to 4 L/min.
• Close the valve of the test cylinder (1).
Test After the pressure drop has stabilized, read the output pressure indicated on
the manometer (2) upstream of the test adapter (3). (This value is equal to
the output pressure of the O2 pin index cylinder regulator).

NOTE
If the pressure does not drop, either the hospital supply pressure is too low or
the regulator pressure is set too high.

The values in the table apply to O2, N2O and Air.

Cylinder pressure Pressure regulator output tolerance


25 bar to 110 bar 2.0 bar to 2.8 bar
110 bar to 200 bar 1.8 bar to 2.6 bar
Result O2 pressure regulator
[________OK]

Action • Close the flow control valves.

N2O pressure regulator


Action • Prepare the pressure regulator test setup and connect the test adapter (3)
to the N2O pipeline supply connector at the device inlet (4).
• Connect the O2 pipeline supply to the O2 pipeline supply connector at
the device inlet (4).
• Open the N2O pin index cylinder valve.
• Set the O2 and N2O flows on the N2O and O2 flow control valves on the
Fabius respectively to 4 L/min.
• Close the valve of the test cylinder (1).
Test After the pressure drop has stabilized, read the output pressure indicated on
the manometer (2) upstream of the test adapter (3). (This value is equal to
the output pressure of the N2O pin index cylinder regulator).
Result N2O pressure regulator (not applicable in nitrous-oxide-free mode)
[________OK]

Action • Close the flow control valves.


No.2301_0000007441

Air pressure regulator


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Function and condition test

Action • Prepare the pressure regulator test setup and connect the test adapter (3)
to the Air pipeline supply connector at the device inlet (4).
• Open the Air pin index cylinder valve.
• Set the Air flow on the Air flow control valve of the Fabius to 4 L/min.
• Close the valve of the test cylinder (1).
Test After the pressure drop has stabilized, read the output pressure indicated on
the manometer (2) upstream of the test adapter (3). (This value is equal to
the output pressure of the Air pin index cylinder regulator).
Result Air pressure regulator
[________OK]

Action • Close the flow control valves.

4.11 Optional high-pressure cylinders, high-pressure regulators


Introduction These instructions describe the procedures for testing the non-return valves
and leak testing for the optional O2 or N2O high-pressure cylinders.
The high-pressure cylinder connections are located on the gas inlet block of
the Fabius.

4.11.1 High-pressure cylinders on the gas inlet block (non-return valves)


Test set-up

1496

Fig. 16 Pipeline supply test setup, non-return valves

Item Designation
1 Flowmeter (7901161)
2 Connecting sleeve (M13506)
3 Reducing sleeve (7900034) / N2O adapter / Air adapter
Action • Connect the relevant O2/N2O high-pressure cylinder to the gas inlet block.
• Connect the test setup in sequence to the O2 and N2O pipeline supply con-
nectors on the gas inlet block.
No.2301_0000007441

• Open the relevant O2/N2O high-pressure cylinder.


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Function and condition test

Test The flow rate indicated on the flowmeter (1) is less than/equal to 5 mL/min.
Result O2 pipeline supply connection max. 5 mL/min.
[________mL/min]

Result N2O pipeline supply connection (not applicable in nitrous oxide-free


mode) max. 5 mL/min.
[________mL/min]

Action • Remove the O2/N2O high-pressure cylinders from the gas inlet block.
• Connect the pipeline supply to the O2 and N2O connectors of the gas inlet
block.
• Connect the test setup in sequence to the O2 and N2O high-pressure cylin-
der connectors on the gas inlet block.
Test The flow rate indicated on the flowmeter (1) is less than/equal to 5 mL/min.
Result O2 high-pressure cylinder connector max. 5 mL/min.
[________mL/min]

Result N2O high-pressure cylinder connector (not applicable in nitrous oxide-


free mode) max. 5 mL/min.
[________mL/min]

4.11.2 O2 high-pressure leakage


Action • Disconnect the pipeline supply tubes from the gas inlet block.
• Make sure the Fabius is switched off at the mains power switch.
• Open the O2 cylinder valve and allow the pressure to stabilize.
• Close the O2 cylinder valve.
• Observe the O2 cylinder manometer.
Test The pressure loss must not exceed 10 bar/min.
Result O2 pressure loss is within tolerance.
[________OK]

4.11.3 N2O high-pressure leakage (not applicable in nitrous oxide-free mode)


Action • Disconnect the pipeline supply tubes from the gas inlet block.
• Make sure the Fabius is switched off at the mains power switch.
• Open the N2O cylinder valve.
• Close the N2O cylinder valve.
• Observe the N2O cylinder manometer.
Test The pressure loss must not exceed 10 bar/min.
Result N2O pressure loss is within tolerance.
[________OK]

4.12 Final procedures


No.2301_0000007441

Prerequisites – The test instructions have been performed as specified.


– All tests performed were passed successfully.
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Test equipment

4.12.1 Test label and device handover


Action • Attach a test label to the device.
• Supply the user/owner with a fully functioning device.
Result Test label and device handover
[________OK]

5 Test equipment

This section sets out the test equipment required for the tests in this test pro-
cedure.

5.1 Test equipment

5.1.1 Test equipment subject to mandatory calibration

NOTE
Tests must be carried out with tests equipment that is calibrated in the appro-
priate way.

Designation Part number


Measuring equipment for electrical 7910594 or equivalent
safety

O2 test pressure regulator 7901482 or equivalent


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Test equipment

Designation Part number


Flowmeter block 0-250 mL 7901161 or equivalent

Digital manometers 7910722 and 7910724 or


equivalent

Stopwatch 7910299 or equivalent

Flowmeter 7900718 or equivalent


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Test equipment

Result Valid calibrated test equipment used.


[________OK]

5.1.2 Test equipment not subject to mandatory calibration

Designation Part number


Plug-in adapter M27964 or equivalent

ISO connector M25647 or equivalent

Test adapter 7900138 or equivalent

Test lung 7911140 or equivalent

Rubber plug 1 x 7901297, 2 x 7901665,


7901298 or equivalent
No.2301_0000007441
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Test equipment

Designation Part number


Blower ball M16118 or equivalent

Kuhn connector M28189 or equivalent

Connecting sleeve M13506 or equivalent

Reducing sleeve 7900034 or equivalent

Gas distributor 7901495 or equivalent

Adapter top M27961


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Annex

Designation Part number


Housing front part 6803596 or equivalent

T-connector 6800187 or 2M12754

PU tube, 2.7 mm 1194925

Plastic-jaw pliers 7910296 or equivalent

Adjustable pin-type face wrench 7911784 or equivalent

Wrench, 3/8 in
Breathing bag, 3-litre
Tube, corrugated, 22 mm x 12 in. long.

6 Annex
No.2301_0000007441

This section contains further information which may be helpful in testing the
device.
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Annex

6.1 Form for customer settings in service mode

Press and hold down the "Standby" and "Home" keys and at the same time
press the rotary knob to access service mode.

Service Entries/actions Enter customer


screen settings here:
Service Log ---------
(Service log)
Entries Clear Service Log ---------
(Entries) (Clear service log)
Real Time Values Displays current val- ---------
(Real-time entries) ues and data
Preventive Activate Mth/Day/Year ---------
Maintenance (Activate) (Month/Day/Year)
(preventive
maintenance)
General ---------
(General)
Serial Number 8-digit serial number
(Serial number) (up to SW 2.10 without
letters, as of SW 2.21
with letters)
Reset Hours Run Yes/No ---------
(Reset hours run) (Yes/No)
Reset Last Ser- Yes/No ---------
vice Date (Yes/No)
(Reset last service
date)
Select Market Kit US (USA)
(Select market kit) European (Europe)
Asian (Asia)
Calibration ---------
(Calibration)
Fresh Gas Flow Store Zero (Store zero) ---------
(Fresh gas flow) Exit (Exit)
Pressure Store Zero (Store zero) ---------
(Pressure) Exit (Exit)
O2 Store Zero (Store zero) ---------
Exit (Exit)
PEEP Calibrate (Calibrate) ---------
Exit (Exit)
Configure ---------
(Configure)
System Settings ---------
(System settings)
Model Type FGS/Tiro/FGS premiu
(Model type) m/FGS plus/FGS
OS/FGS MRI/FGS plus
No.2301_0000007441

XL
O2 Monitoring Enable/Disable
(O2 monitoring) (enable/disable)
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Annex

Service Entries/actions Enter customer


screen settings here:
Hardware Set-
tings
(hardware set-
tings)
Display Size 6.5 inch or 5.7 inch
(Display size)
Flowsensor Type Sensirion or Honeywell
(flow sensor
type)
Speaker Version A (old) or B (new)
(loudspeaker
version)
Standard Options ---------
(Standard options)
Flowmeter ---------
(Flowmeter)
O2 Position Right/Left
(Right/left)
Gas Selection 2/3
(Gas selection)
Flowtube Res. Normal (normal resolu-
(Flowtube resolu- tion)
tion) High Res. (high resolu-
tion)
Flowtube Color Selection:
(flowmeter tube – ISO
colour)
– US
– CHINESE
– ARGENTINA
– NEUTRAL
O2 Whistle ---------
(O2 alarm)
Change State Enable/Disable
(Change state) (enable/disable)
Alarms ---------
(Alarms)
No Fresh Gas Enable/Disable
(No fresh gas) (enable/disable)
Fresh Gas Low Enable/Disable
(Fresh gas low) (enable/disable)
Threshold Low Enable/Disable
(Threshold low) (enable/disable)
Alarm Acoustics ON/OFF
(Acoustic alarm) (Activate/deactivate
low priority acoustic
alarm)
No.2301_0000007441

Pressure ---------
(Pressure)
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Annex

Service Entries/actions Enter customer


screen settings here:
Ambient Pres- Adjust
sure (adjust)
(Ambient pres-
sure)
Plateau/Mean Change Display
Display (Change display)
(Airway pressure
display)
Secure Options Enable/Disable
(secure options) (enable/disable)
PCV Vent Mode
(PCV ventilation
mode)
PSUP Vent Mode
(PSUP ventila-
tion mode)
SIMVPS
Colour Mode
Site Default Pass-
word
(Set password)
Serial Port ---------
(Serial port)
Parameters Pass thru disabled
(Parameters) enabled
COM 1/COM 2 COM1:
COM2:
Baud Rate 1200, 2400, 4800, COM1:
(Baud rate) 9600, 19200, 38400 COM2:
Parity None/Even/ODD COM1:
(Parity) (None/even/odd) COM2:
Stopp Bits 1, 2 COM1:
(Stop bits) COM2:
Data Bits 7, 8 COM1:
(Data bits) COM2:
Protocol Vitalink/Medibus COM1:
(Protocol) COM2:

6.2 Ambient pressure

Altitude range (feet) Altitude range (metres) Barometric pressure setting


(hPa/mbar)
-200 to +199 -60 to +60
200 to 599 61 to 182 1000
600 to 999 183 to 304 985
No.2301_0000007441

1000 to 1399 305 to 426 970


1400 to 1799 427 to 548 960
1800 to 2199 549 to 670 945
No.3103_0000001949

2200 to 2599 671 to 792 930

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Annex

Altitude range (feet) Altitude range (metres) Barometric pressure setting


(hPa/mbar)
2600 to 2999 793 to 914 920
3000 to 3399 915 to 1036 905
3400 to 3799 1037 to 1158 890
3800 to 4199 1159 to 1280 880
4200 to 4599 1281 to 1401 865
4600 to 4999 1402 to 1523 855
5000 to 5399 1524 to 1645 840
5400 to 5799 1646 to 1767 830
5800 to 6199 1768 to 1889 820
6200 to 6599 1890 to 2011 805
6600 to 6999 2012 to 2133 795
7000 to 7399 2134 to 2255 785
7400 to 7799 2256 to 2377 770
7800 to 8199 2378 to 2499 760
8200 to 8599 2500 to 2620 750
8600 to 8999 2621 to 2742 740
9000 to 9399 2743 to 2864 730

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3 Result Sheet Test instructions / Service Card IPM

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Result Sheet Test Instructions / Service Card IPM


Fabius plus

Order number: 9500840

Location: Serial no. (basic unit):

Department: Cust. invent. no.:

Maintenance interval: Other / Delivery date:

Key

9 / OK = OK
Applies to Test Instructions / Service Card IPM Revision 3.0 + = Spare part used
! = Error / Report
/ = Accessory not available
- = Not applicable

Test Result Test Result


1 Device configuration 3.1.2 Protective earth resistance
1.1 Basic device configuration … 3.1.2.1 Maximum measured value of device with pow- ȍ
er cable.
1.1.1 Serial number / software (if not otherwise record-
ed) … 3.1.2.2 Maximum measured value of optional power ȍ
cable.
… 1.1.1.1 Device serial number txt
… 3.1.2.3 Maximum measured value of ME system. ȍ
… 1.1.1.2 Serial number of the breathing system (CO- txt
SY2) … 3.1.3 Protective earth resistance measuring points OK
… 1.1.1.3 Serial number of optional bronchial suction de- txt 3.1.4 Equipment leakage current
vice … 3.1.4.1 Reference value —A
… 1.1.1.4 Optional external monitoring device txt … 3.1.4.2 Recurrent measurement —A
2 Maintenance parts 3.2 Option: Electrical safety, COSY2 heater power sup-
2.1 Maintenance intervals, overview ply unit, to DIN EN 62353 (IEC 62353)
2.2 Maintenance parts by specified interval … 3.2.1 Visual check OK
… 2.2.1 Lithium battery (every 3 years) dat 3.2.2 Protective earth resistance
… 2.2.2 Lead-gel battery (3-yearly) dat … 3.2.2.1 Maximum measured value of device with pow- ȍ
er cable.
2.2.3 Input pressure regulator test (every 3 years)
… 3.2.2.2 Maximum measured value of ME system. ȍ
2.2.3.1 Downstream pressure of pipeline supply O2 in-
put pressure regulator … 3.2.3 Protective earth resistance measuring points OK
… O2 pipeline supply inlet pressure regulator downstream OK 3.2.4 Equipment leakage current
pressure, every 3 years … 3.2.4.1 Reference value —A
… Next test dat … 3.2.4.2 Recurrent measurement —A
2.2.3.2 Downstream pressure of pipeline supply N2O 3.3 Electrical safety according to IEC 60601-1
input pressure regulator (not applicable in ni-
… 3.3.1 Base unit OK
trous-oxide-free mode)
… 3.3.2 Protective earth resistance ȍ
… N2O pipeline supply input pressure regulator downstream OK
pressure (not applicable in nitrous-oxide-free mode) 3.3.3 Earth leakage current
… Next test dat … 3.3.3.1 Normal condition (N.C.) —A
2.2.4 Drägersorb CLIC option … 3.3.3.2 Single fault condition (S.F.C.) —A
… 2.2.4.1 Drägersorb Clic option (old, yearly) dat … 3.3.4 Optional COSY2 heater power supply unit, pro- ȍ
tective earth conductor resistance
… 2.2.4.2 Drägersorb Clic option (new, yearly) dat
3.3.5 Optional COSY2 heater power supply unit, earth
… 2.2.4.3 Drägersorb Clic option (old, every 2 years) dat
leakage current
… 2.2.4.4 Drägersorb Clic option (new, every 2 years) dat
… 3.3.5.1 Normal condition (N.C.) —A
… 2.2.4.5 Drägersorb Clic option (every 4 years) dat
… 3.3.5.2 Single fault condition (S.F.C.) —A
2.2.5 Pin index option (every 6 years)
4 Function and condition test
… 2.2.5.1 Option: Upgrade kit, N2O pressure regulator, dat
4.1 Base unit
long
… 4.1.1 Labels and instructions for use OK
… 2.2.5.2 Option: Upgrade kit, N2O pressure regulator, dat
short … 4.1.2 Condition and function of the base unit OK
… 2.2.5.3 Option: Upgrade kit, O2 pressure regulator, dat … 4.1.3 Tubing (PAE, PA, fabric-reinforced) OK
short T … 4.1.4 Condition and function of vaporizer mount and in- OK
… 2.2.5.4 Option: Upgrade kit, O2/Air pressure regulator, dat terlock
long L 4.2 Basic unit self-test, calibration and leakage test
… 2.2.5.5 Option: Upgrade kit, O2/Air pressure regulator, dat 4.2.1 Self-test/system diagnostics of the base unit
short L
… 4.2.1.1 Entering the software version. txt
3 Electrical safety
… 4.2.1.2 Self-test successfully completed. OK
3.1 Electrical safety, base unit, to DIN EN 62353 (IEC
62353) 4.2.2 O2 sensor calibration (not applicable in case of
monitoring with external O2 measurement)
… 3.1.1 Visual check OK
No.3103_0000001949

… 4.2.2.1 O2 sensor calibr. OK

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Test Result Test Result


… 4.2.2.2 O2 concentration % … 4.10.1.3 Non-return valve and manometer OK
… 4.2.3 Flow sensor calibration OK 4.10.2 Checking the pressure regulator option of the pin
… 4.2.4 Leak tightness of breathing system OK index cylinders
4.2.5 Fresh gas leakage test passive (with and without … 4.10.2.1 O2 pressure regulator OK
vaporizer) … 4.10.2.2 N2O pressure regulator (not applicable in ni- OK
… 4.2.5.1 Leak test of flow control valves OK trous-oxide-free mode)
… 4.2.5.2 Fresh gas leakage with vaporizer OK … 4.10.2.3 Air pressure regulator OK
… 4.2.5.3 Fresh gas leakage without Vapor. OK 4.11 Optional high-pressure cylinders, high-pressure
regulators
… 4.2.6 Nitrous oxide-free option: Fresh gas leakage pas- OK
sive test 4.11.1 High-pressure cylinders on the gas inlet block
(non-return valves)
4.3 Service data and basic unit calibration
… 4.11.1.1 O2 pipeline supply connection mL/min
4.3.1 Service data
… 4.11.1.2 N2O pipeline supply connection (not applica- mL/min
… 4.3.1.1 last service date dat ble in nitrous oxide-free mode)
… 4.3.1.2 next due service date dat … 4.11.1.3 O2 high-pressure cylinder connector mL/min
… 4.3.2 Pressure OK … 4.11.1.4 N2O high-pressure cylinder connector (not ap- mL/min
4.3.3 Pump calibration and vacuum test plicable in nitrous oxide-free mode)
… 4.3.3.1 Ambient pressure OK … 4.11.2 O2 high-pressure leakage OK
… 4.3.3.2 Vacuum test performed and pump calibrated OK … 4.11.3 N2O high-pressure leakage (not applicable in ni- OK
trous oxide-free mode)
… 4.3.4 PEEP calibration OK
4.12 Final procedures
… 4.3.5 O2 offset (not applicable to external O2 measure- OK
ment) … 4.12.1 Test label and device handover OK
4.4 Power failure, O2 sensor, flow sensor alarms 5 Test equipment
… 4.4.1 Power failure alarm, battery circuit OK 5.1 Test equipment
… 4.4.2 O2 low alarm bar … 5.1.1 Test equipment subject to mandatory calibration OK
… 4.4.3 Flow sensor failure alarm OK 5.1.2 Test equipment not subject to mandatory calibra-
tion
… 4.4.4 O2 sensor failure alarm (not applicable in case of OK
monitoring with external O2 measurement) 6 Annex
4.5 Flowmeter test 6.1 Form for customer settings in service mode
… 4.5.1 Comparative flow measurement with external OK 6.2 Ambient pressure
flowmeter block
… 4.5.2 Safety valve of flowmeter block OK
4.6 SORC test (not applicable in nitrous oxide-free
mode)
… 4.6.1 N2O shut-off (not applicable in nitrous oxide-free OK
mode)
4.6.2 O2 concentration and gas type test (not applicable
in nitrous oxide-free mode)
… 4.6.2.1 Air pipeline supply manometer indicates pipe- OK
line pressure
… 4.6.2.2 No O2 or N2O flow OK
… 4.6.2.3 O2 pipeline supply manometer indicates pipe- OK
line pressure.
… 4.6.2.4 No Air or N2O flow OK
… 4.6.2.5 O2 concentration OK
… 4.6.2.6 No Air flow OK
4.6.3 SORC function (not applicable in nitrous oxide-
free mode)
… 4.6.3.1 O2 concentration OK
… 4.6.3.2 N2O flow L/min
… 4.6.3.3 O2 flow L/min
4.7 Additional tests
… 4.7.1 Pressure-limiting valve and auxiliary-air valve OK
… 4.7.2 Pmax accuracy OK
4.8 Ventilation modes
… 4.8.1 Manual ventilation OK
… 4.8.2 Spontaneous breathing OK
4.8.3 Lung ventilator performance
… 4.8.3.1 Ventilator is running quietly and smoothly OK
… 4.8.3.2 Volume delivery mL
… 4.9 PEEP pressure accuracy OK
4.10 Optional pin index cylinder connections, manome-
ters, and pressure regulators
4.10.1 Cylinder connections, non-return valves, manom-
eters
… 4.10.1.1 Cylinder connections OK
No.3103_0000001949

… 4.10.1.2 Leakage OK

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Result Sheet Test instructions / Service Card IPM

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Manufacturer:

Dräger Medical GmbH


Moislinger Allee 53 – 55
23542 Lübeck
Germany

+49 1805 3723437

FAX +49 451 882 - 3779

http://www.draeger.com

As of 2015-08:
Dräger Medical GmbH
changes to
Drägerwerk AG & Co. KGaA

Subject to change without notice


Will not be replaced in the event of modifications.

© Copyright 2015 by Dräger Medical GmbH, Lübeck, Germany.

Revision 3.0
9036798
5330.450
No.3103_0000001949

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