Fabius plus XL
Inhalation Anesthesia Machine
Technical Documentation IPM
Fabius plus XL
This page has been left blank intentionally.
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Technical Documentation IPM
| Fabius plus XL
Table of contents
Table of contents
Fabius plus
Inhalation
Anesthesia
XL
Machine
1
General ......................................................................................................
4
1.1
General notes .................................................................................
4
Function descriptions..............................................................................
8
2.1
2.2
2.3
2.4
System overview.............................................................................
Leak test .........................................................................................
Ventilation modes ...........................................................................
Wall-mounted unit...........................................................................
8
11
14
21
Function descriptions pneumatic assembly..........................................
23
3.1
3.2
3.3
3.4
3.5
3.6
3.7
Ventilator.........................................................................................
Pneumatic assembly.......................................................................
Function description of the gas box ................................................
SORC (Sensitive Oxygen Ratio Controller) ....................................
Cosy 2.6 breathing system .............................................................
Anaesthetic vaporizer .....................................................................
Semi-open adapter .........................................................................
23
26
27
28
29
31
32
Function descriptions - Electronics .......................................................
36
4.1
4.2
4.3
4.4
4.5
4.6
4.7
Control PCB....................................................................................
Electrical block diagram..................................................................
Operator control..............................................................................
Battery backup................................................................................
FiO2 measurement .........................................................................
Respiratory Flow Measurement......................................................
Fabius plus XL power supply unit ...................................................
36
37
37
39
39
40
41
5
Parts catalog.............................................................................................
42
6
Test Documents .......................................................................................
102
6.1
6.2
102
150
2
3
4
Test instructions / Service Card IPM ..............................................
Result Sheet Test instructions / Service Card IPM.........................
Technical Documentation IPM | Fabius plus XL
3
General
1
General
This chapter contains general notes and definitions that are important for the use of
this documentation.
1.1
General notes
1.1.1
Notes on use
Read the following notes carefully before applying the information contained in this
documentation.
The basic safety information defined here applies to all sections of this
documentation.
Dräger reserves the right to make changes to the product or this documentation
without prior notice. This documentation is intended solely for the purpose of
information when servicing the device.
Illustrations in this documentation are provided as examples and may differ from the
actual product or the language available.
1.1.2
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 (in full or in parts) may not be modified, copied, distributed, reproduced, republished, displayed, transmitted or sold without the written permission of the
author.
1.1.3
Definitions
WARNING
A WARNING statement provides important information about a potentially
hazardous situation which, if not avoided, could result in death or serious
injury.
CAUTION
A CAUTION statement provides important information about a potentially
hazardous situation which, if not avoided, could result in personal injury or
property damage.
NOTE
A NOTE provides additional information intended to avoid inconvenience during
operation or service of the product.
Term
Service
Inspection
4
Definition
All measures (inspection, maintenance, repair) intended to
maintain or restore the functional integrity of a product
Measures intended to determine and assess the current state
of a product
Technical Documentation IPM | Fabius plus XL
General
Term
Maintenance
Repair
1.1.4
Definition
Regular specified measures intended to maintain the functional integrity of a product
Measures intended to restore the functional integrity of a
product after a failure
Laws, regulations and standards
German laws, regulations and standards apply to devices used and serviced in
Germany. Users or service personnel in other countries are obliged to comply with
relevant national laws and with international standards.
1.1.5
Basic safety information
WARNING
Danger due to non-compliance with the documentation
Without exact knowledge of and compliance with this documentation,
carrying out the measures described herein could lead to personal injury,
damage to property, or damage to the environment. Using the product
without exact knowledge of and compliance with the corresponding
instructions for use could lead to personal injury, damage to property, or
damage to the environment.
– Make sure that you have the current revision of this documentation. Use
only the current revision of this documentation.
– Carefully read and comply with the measures described in this
documentation.
– Carefully read and comply with the corresponding instructions for use.
WARNING
Danger due to servicing work that is not carried out regularly or carried out
incorrectly
Service activities that are not carried out, carried out incorrectly or by nonexperts can lead to personal injury, property damage or environmental
damage. If the safety, functionality and condition of the product are not
checked during servicing work, risks can go undetected.
– Observe the servicing information contained in the instructions for use.
– Service activities must be carried out regularly and correctly by the user
group named for the respective activity.
– Only perform service activities and only connect the service PC if no
patient is connected to the product.
– Dräger recommends the use of original parts for servicing work.
– Whenever servicing work has been performed, check the product
according to the test instructions.
Technical Documentation IPM | Fabius plus XL
5
General
WARNING
Danger due to an untested product
Failure to check the safety, function and condition of the product when
performing servicing work may result in risks remaining undetected and
subsequently in personal injury, property damage, or environmental
damage.
When performing servicing work, check the product according to the test
instructions.
WARNING
Danger due to non-compliance with test values
If test values do not conform to specifications, the patient’s safety 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
Danger due to modifications to the product
Modifications to the product may result in malfunctions and subsequently in
personal injury, property damage, or environmental damage.
Modify the product only with Dräger's approval.
WARNING
Risk of infection
After clinical use, the device may be contaminated and transmit pathogens.
There is an increased risk of infection with products that have not been
reprocessed.
– Only service reprocessed (cleaned and disinfected) devices and device
components.
– In the case of possibly contaminated components that cannot be
reprocessed (e.g., in interiors) take suitable protective measures (such as
wearing gloves and a face mask).
CAUTION
Damage to the device due to improper tools or test equipment
If improper tools or test equipment are used during maintenance, the device may
be damaged and its function impaired.
– Use only suitable tools or the specified test equipment when performing
maintenance work.
– If present, note the expiration date of the specified test equipment.
CAUTION
Damage to the device due to electrostatic discharge
Electrostatic discharge may damage electrostatic sensitive devices.
When working on electrostatic sensitive devices, take suitable protective
measures against electrostatic discharge (use, e.g., an anti-static mat and an
earthing wrist strap).
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Technical Documentation IPM | Fabius plus XL
General
CAUTION
Risk of environmental damage
Components that have been replaced or can no longer be used may contain
environmentally harmful substances or pollutants. Components that have not
been disposed of in accordance with regulations can lead to environmental
damage.
Dispose of replaced and non-reusable components in accordance with
regulations.
Technical Documentation IPM | Fabius plus XL
7
Function descriptions
2
Function descriptions
This chapter contains descriptions of the device's technical functions.
2.1
System overview
2.1.1
Introduction
The following text describes the structure, the functional principle, and the
connections of the Fabius plus XL.
2.1.2
Design
The Fabius plus XL 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
2.1.3
Functional principle
The Fabius plus XL is an inspiratory anaesthetic unit with continuous flow.
The integrated components monitor the airway pressure, the volume, and the
fraction of inspired oxygen.
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Function descriptions
Connections, interfaces, and components
17940
2.1.4
Fig. 1
No.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Front view of Fabius plus XL
Designation
Compact breathing system
Ventilator
Additional oxygen flowmeter
Interlock Vapor mount
O2 flush
Control panel (settings for ventilation parameters and airway monitoring)
Screen display
Manometer for pin-index cylinders (O2, N2O)
Manometer for central gas supply
Flowmeter block
Valves for fresh-gas metering
Scio (option)
Trolley
Drawer
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17939
Function descriptions
Fig. 2
No.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
10
Rear view of Fabius plus XL, control box
Designation
ON/OFF switch
COM1 (serial port)
Volume sensor (Spirolog sensor)
Airway pressure connection
Oxygen sensor connection
PEEP (tube connector for PEEP valve)
APL (tube connector for APL bypass valve)
Fuse of Cosy-heater (optional)
Cosy heater, fuse connection (optional)
Additional multiple socket outlet (optional)
Power cord strain relief
Mains power connection (for additional multiple socket outlet)
Battery fuse
Power cable connection (with fuses) (with optional additional multiple socket outlet)
Technical Documentation IPM | Fabius plus XL
17941
Function descriptions
Fig. 3
Rear view of Fabius, gas inlet block; is either as high-pressure cylinder
connection version or as PIN index version designed. This Figure shows
both versions for example.
Item
1
Designation
Two vertically-arranged inlets for the reserve gas cylinders (from top to
bottom: N2O and O2) (optional)
Three vertically-arranged inlets for pipeline gas supply (from top to bottom: N2O, AIR and O2)
Pin-index connector for N2O or AIR (optional)
Pin-index connector for O2 (optional)
2
3
4
2.2
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.
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Function descriptions
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.
2.2.1
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 onscreen 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.
System leak test value
[mL/min]
≤
250
251 to 350
>350
Displayed result
[mL/min]
Measured value and "PASS"
Measured value and "FAIL"
>350 and "FAIL"
High system leakage, alongside other leakage, may also be caused by a faulty sum
total flowmeter.
2.2.2
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.
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Function descriptions
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
[mL/min]
≤
150
151 to 250
>250
2.2.3
Displayed result
[mL/min]
Measured value and "PASS"
Measured value and "FAIL"
>250 and "FAIL"
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.
Technical Documentation IPM | Fabius plus XL
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Function descriptions
Ventilation modes
5534
2.3
Fig. 4
14
Function diagram of ventilation modes
Technical Documentation IPM | Fabius plus XL
Function descriptions
Key to all the following ventilation modes
Item
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
2.3.1
Designation
Manual breathing bag
Fresh gas inlet
Fresh gas isolation
Ventilator
Inspiratory valve
Pressure sensor
Oxygen sensor
Inspiratory tube
Y-piece
Lung
Expiratory tube
Flow sensor
PEEP/Pmax valve
Expiratory valve
APL bypass valve
APL valve
Non-return valve
Absorber
Function Description: Manual ventilation
Manual ventilation: General
During manual ventilation, the APL valve is set to the "MAN" position. The 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: Inspiration
During inspiration, expiratory valve 14 remains closed. When the operator
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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4207
Function descriptions
Fig. 5
Manual ventilation (inspiration) - Cosy 2.6 breathing system
Manual ventilation: Expiration – Cosy 2.6 breathing system
During expiration, the inspiratory valve remains closed thus preventing the
expiratory gas from flowing back into the inspiratory branch.
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.
16
Technical Documentation IPM | Fabius plus XL
4209
Function descriptions
Fig. 6
2.3.2
Manual ventilation (expiration) - Cosy 2.6 breathing system
Function Description: Spontaneous breathing
Spontaneous breathing: General
A prerequisite for spontaneous breathing is that the patient is supplied with a
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: Inspiration
During inspiration, the expiratory valve remains closed thus preventing 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.
Technical Documentation IPM | Fabius plus XL
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4211
Function descriptions
Fig. 7
Spontaneous breathing (inspiration) - Cosy 2.6 breathing system
Spontaneous breathing: Expiration – Cosy 2.6 breathing system
During expiration, the inspiratory valve remains closed thus preventing the
expiratory gas from flowing back into the inspiratory branch.
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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Technical Documentation IPM | Fabius plus XL
4213
Function descriptions
Fig. 8
2.3.3
Spontaneous breathing (expiration) - Cosy 2.6 breathing system
Function Description: volume/pressure control ventilation mode
volume control ventilation mode: General
A prerequisite for volume control ventilation is that the patient is supplied with 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 ventilation mode: Inspiration
During inspiration, the PEEP/Pmax valve remains closed. The control pressure
present at the PEEP/Pmax valve varies with the set pressure limit (Pmax).
The item numbers mentioned in the following paragraphs refer to Fig. 9.
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 pressure. The
Technical Documentation IPM | Fabius plus XL
19
Function descriptions
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.
4215
Any excess fresh gas flows through the open APL bypass valve 15, and the nonreturn valve 17 into the anaesthetic gas scavenging system.
Fig. 9
Volume-controlled ventilation (inspiration) - Cosy 2.6 breathing system
Volume/pressure control ventilation mode: Expiration
During expiration, the inspiratory valve remains closed thus preventing rebreathing
into the inspiratory branch.
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 nonreturn valve 17 into the anaesthetic gas scavenging system.
20
Technical Documentation IPM | Fabius plus XL
4217
Function descriptions
Fig. 10
2.4
Volume-controlled ventilation (expiration) - Cosy 2.6 breathing system
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.
2.4.1
Introduction
The illustrations accompanying this description are generic depictions.
The following describes the rotation function of the wall-mounted unit.
Technical Documentation IPM | Fabius plus XL
21
Function descriptions
Rotation function
5482
2.4.2
Fig. 11
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.
5480
5. Turn the locking lever 180° anti-clockwise.
Fig. 12
Lock catch recess (1)
6. Make sure the lock catch is engaged.
The unit is secure in this position.
22
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Function descriptions pneumatic assembly
3
Function descriptions pneumatic assembly
This chapter contains descriptions of the device's technical functions.
3.1
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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4218
Function descriptions pneumatic assembly
Fig. 13
Item
1
2
3
4
5
6
7
8
9
10
11
Ventilator (piston shown in ‘down’ position)
Designation
Ventilator housing
Safety valve
Auxiliary air valve
Ventilator pressure sensor line
Vacuum line to the pneumatic assembly
Upper seal
Piston
Lower seal
Motor/ballscrew assembly
Incremental encoder
Light barrier
The top of the ventilator assembly (patient system) contains two valves:
3.1.1
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).
24
Technical Documentation IPM | Fabius plus XL
4219
Function descriptions pneumatic assembly
3.1.2
Fig. 14
Sectional view of the safety valve
Item
1
2
3
4
5
Designation
Screw
Spring
Crater
Washer
Valve disk
Auxiliary air valve
8050
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.
Fig. 15
Sectional view of the auxiliary air valve
Item
1
2
3
4
Designation
Threaded ring
Valve disk
Valve cross with spring
Connecting screw
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25
Function descriptions pneumatic assembly
3.2
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.
3.2.1
PEEP/Pmax valve control
19125
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. 16.
Fig. 16
3.2.2
Schematic of the pneumatic control
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.
The variable restrictor is used to set the negative pressure level in a range of –150
mbar (cmH2O) to –240 mbar (cmH2O).
26
Technical Documentation IPM | Fabius plus XL
Function descriptions 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.
3.3
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.
4133
If the O2 supply fails or its pressure decreases below a certain limit, the O2 low
alarm switch generates an alarm.
Fig. 17
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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27
9586
Function descriptions pneumatic assembly
Fig. 18
3.4
Gas box function diagram, part 2
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.%.
9587
The SORC bypass valve allows oxygen to bypass the restrictor in the SORC when
O2 flows above 10 L/min are needed.
Fig. 19
28
SORC function diagram, part 1
Technical Documentation IPM | Fabius plus XL
Function descriptions pneumatic assembly
The O2 and N2O flows are adjusted with the flow control valves.
Resistors located at the outlets of the SORC generate back-pressures. These backpressures exert a force on the control diaphragms of the SORC. The O2 backpressure opens the SORC. The N2O back-pressure closes the SORC. The
pressure ratio at the control diaphragm affects the N2O flow.
4221
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.
Fig. 20
Item
1
2
3
4
5
3.5
SORC function diagram, part 2
Designation
Control diaphragms
Resistors
N2O non-return valve
Operating-point adjusting screw
Flow control valves
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.
Technical Documentation IPM | Fabius plus XL
29
Function descriptions pneumatic assembly
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.
4136
The absorber canister is filled with fresh soda lime. The CO2 is scrubbed from the
expiratory gas by the soda lime.
Fig. 21
Item
1
2
3
4
5
6
7
8
9
10
11
30
Cosy 2.6 breathing system
Designation
Inspiratory connection
Pressure sensor connection (not visible)
Inspiratory valve and O2 sensor connection
Fresh gas isolation valve
APL bypass valve
PEEP/Pmax valve
MAN/SPONT APL valve
Anaesthesia monitor return line (only for systems outside the USA)
Fresh gas port
Ventilator connection
Anaesthetic gas scavenging port
Technical Documentation IPM | Fabius plus XL
Function descriptions pneumatic assembly
Designation
Absorber
Breathing bag terminal and standby holder for Y-piece
Breathing bag hook
Flow sensor (Spirolog) (not shown)
Expiratory connection
Expiratory valve
Fig. 22
Function diagram of Fabius – Cosy 2.6 breathing system
4130
Item
12
13
14
15
16
17
3.6
Anaesthetic vaporizer
Refer to separate technical documentation of the anaesthetic vaporizer.
Technical Documentation IPM | Fabius plus XL
31
Function descriptions pneumatic assembly
3.7
Semi-open adapter
The semi-open adapter is used in conjunction with the Cosy 2.6 patient system.
3.7.1
Manual ventilation: General information
The item numbers mentioned in the following paragraphs refer to Fig. 23.
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.
3.7.2
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.
4801
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.
Fig. 23
32
Manual ventilation, inspiration
Technical Documentation IPM | Fabius plus XL
Function descriptions pneumatic assembly
3.7.3
Manual ventilation: Expiration
The item numbers mentioned in the following paragraphs refer to Fig. 24
During expiration, the inspiratory valve 3 remains closed thus preventing the
expiratory gas from flowing back into the inspiratory branch.
4824
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 same time, new fresh gas
2 flows into the manual breathing bag 1.
Fig. 24
3.7.4
Manual ventilation, expiration
Spontaneous breathing: General information
The item numbers mentioned in the following paragraphs refer to Fig. 25.
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.
Technical Documentation IPM | Fabius plus XL
33
Function descriptions pneumatic assembly
3.7.5
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.
4803
Any excess amount of the gas mixture flows into the anaesthetic gas scavenging
system 12 and13.
Fig. 25
3.7.6
Spontaneous breathing, inspiration
Spontaneous breathing: Expiration
The item numbers mentioned in the following paragraphs refer to Fig. 26.
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 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.
34
Technical Documentation IPM | Fabius plus XL
Function descriptions pneumatic assembly
4804
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.
Fig. 26
Spontaneous breathing, expiration
Technical Documentation IPM | Fabius plus XL
35
Function descriptions - Electronics
4
Function descriptions - Electronics
This chapter contains descriptions of the device's technical functions.
4.1
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
4225
– The required supply voltages are supplied by the power supply unit.
Fig. 27
36
Controller functional block diagram
Technical Documentation IPM | Fabius plus XL
Function descriptions - Electronics
Electrical block diagram
8038
4.2
Fig. 28
4.3
Electrical block diagram
Operator control
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 30conductor ribbon cable. A block diagram of the control unit assembly is shown in
the following illustration.
Technical Documentation IPM | Fabius plus XL
37
5527
Function descriptions - Electronics
Control unit block diagram
Fig. 30
Fabius control unit ("Standby" screen shown)
Item
1
Function
Programmable keys: Activate the corresponding function that appears on
screen above the key
Switches the ventilator to MAN/SPONT mode
Option SIMV/PS
Pressure Support option
Selects pressure controlled ventilation mode
Selects volume controlled ventilation mode
For setting alarm limits
Setup key: Activates sub-screens for monitoring functions.
Home key: Returns display to main screen shown before standby
Alarm status indicators:
Flashing red: Warning; flashing yellow: Caution; solid yellow: Note
Alarm silence key: Silences all active alarms for two minutes
The alarm LED indicates a low O2 central gas supply.
Power ON LED: Lighted when unit is plugged into an active mains outlet
Switches the device back to standby mode.
17813
Fig. 29
2
3
4
5
6
7
8
9
10
11
12
13
14
38
Technical Documentation IPM | Fabius plus XL
Function descriptions - Electronics
Item
15
4.4
Function
Rotary encoder: Moves the cursor on the screen; confirms selection when
pressed
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.
4131
The batteries are located inside the control box. The 3.15 A battery fuse is located
at the rear of the control box.
Fig. 31
4.5
Battery backup arrangement
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.
Technical Documentation IPM | Fabius plus XL
39
4228
Function descriptions - Electronics
Fig. 32
Item
1
2
3
4
5
6
O2 sensor
Designation
Teflon membrane
Gold cathode A
Lead anode
Temperature compensation resistors
Alkaline electrolyte
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 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.
If the O2 sensor fails, the control box will indicate an error on the graphics display.
4.6
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.
40
Technical Documentation IPM | Fabius plus XL
Function descriptions - Electronics
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.
4229
Internal calibration tables for O2/N2O mixtures, Air and 100% O2 are used to
linearize the measured flow.
Fig. 33
Item
"A"
"B"
4.7
Respiratory flow sensor
Designation
Platinum wire "A"
Platinum wire "B"
Fabius plus XL power supply unit
The power supply unit provides the necessary voltages for the Control PCB, battery
charging and optional Cosy heater.
The power supply unit provides no facility to adjust the voltage.
4.7.1
Cosy heater power module
If the Fabius plus XL is fitted with the Cosy heater option, it additionally has a
DC/DC converter which controls the Cosy heater.
Technical Documentation IPM | Fabius plus XL
41
Parts catalog
5
Parts catalog
Test Instructions
This chapter contains the measures required to determine the actual condition of
the device.
42
Technical Documentation IPM | Fabius plus XL
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Test Documents
6
Test Documents
Test Instructions
This chapter contains the measures required to determine the actual condition of
the device.
6.1
102
Test instructions / Service Card IPM
Technical Documentation IPM | Fabius plus XL
Test instructions / Service Card IPM
17943
Fabius plus XL
Revision 4.0
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Table of contents
1
1.1
2
2.1
2.2
3
3.1
3.2
3.3
4
4.1
2 / 47
Important notes
5
Device configuration
5
Basic device configuration ....................................................................................................... 6
1.1.1
Serial number ............................................................................................................ 6
Maintenance parts
6
Maintenance intervals, overview.............................................................................................. 6
Maintenance parts by specified interval................................................................................... 7
2.2.1
Lithium battery (every 3 years) .................................................................................. 7
2.2.2
Lead-gel battery (3-yearly) ........................................................................................ 8
2.2.3
Input pressure regulator test (every 3 years)............................................................. 8
2.2.3.1
Test: Downstream pressure of central supply O2 input pressure regulator, every 8
3 years .......................................................................................................................
2.2.3.2
Test: Downstream pressure of central supply N2O input pressure regulator,
9
every 3 years (not applicable in nitrous-oxide-free mode).........................................
2.2.4
(Option) Drägersorb CLIC ......................................................................................... 10
2.2.4.1
Set of seals for Drägersorb CLIC, white seal (annually) ....................................... 10
2.2.4.2
Set of seals for Drägersorb CLIC, blue seal (annually) ......................................... 10
2.2.4.3
Set of seals for Drägersorb CLIC, white seal (every 2 years) ............................... 10
2.2.4.4
Set of seals for Drägersorb CLIC, blue seal (every 2 years)................................. 10
2.2.4.5
Drägersorb CLIC adapter, gray seal (every 4 years)............................................. 11
2.2.5
(Option) Pin index (6-yearly)...................................................................................... 11
Electrical safety
12
Electrical safety, base unit, to DIN EN 62353 (IEC 62353) ...................................................... 12
3.1.1
Visual inspection........................................................................................................ 13
3.1.2
Protective earth resistance ........................................................................................ 14
3.1.3
Protective earth resistance measuring points............................................................ 15
3.1.4
Device leakage current.............................................................................................. 15
(Option) Electrical safety, power supply unit COSY 2.n heater in accordance with DIN EN
16
62353 (IEC 62353)
3.2.1
Visual inspection........................................................................................................ 16
3.2.2
Protective earth resistance ........................................................................................ 17
3.2.3
Protective earth resistance measuring points............................................................ 17
3.2.4
Device leakage current.............................................................................................. 18
Electrical safety according to IEC 60601-1 .............................................................................. 19
3.3.1
Base unit.................................................................................................................... 19
3.3.2
Protective earth resistance ........................................................................................ 20
3.3.3
Earth leakage current ................................................................................................ 20
3.3.4
(Option) Power supply unit COSY 2.n heater, protective earth resistance ................ 21
3.3.5
(Option) Power supply unit COSY 2.n heater, earth leakage current ........................ 22
Function and condition test
22
Base unit .................................................................................................................................. 23
4.1.1
Labels and instructions for use.................................................................................. 23
4.1.2
Condition and function of the base unit ..................................................................... 23
4.1.3
Tubing (PAE, PA, fabric-reinforced) ........................................................................... 23
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Table of contents
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Table of contents
4.1.4
Condition and function of vaporizer mount and interlock ..........................................
Self-test, calibration and tightness of the main device.............................................................
4.2.1
Self-test/system diagnostics of the base unit ............................................................
4.2.2
O2 sensor calibration (not applicable in case of monitoring with external O2
measurement) ...........................................................................................................
4.2.3
Flow sensor calibration..............................................................................................
4.2.4
Tightness check of the breathing system ..................................................................
4.2.5
Fresh gas leakage test passive (with and without vaporizer)....................................
4.2.6
(Option) Operation without nitrous oxide: Fresh gas leakage passive test ...............
4.3 Service data and basic unit calibration ....................................................................................
4.3.1
Service data ..............................................................................................................
4.3.2
Pressure ....................................................................................................................
4.3.3
Pump calibration and vacuum test ............................................................................
4.3.4
PEEP calibration .......................................................................................................
4.3.5
O2 offset (not applicable to external O2 measurement)............................................
4.4 Alarms (e.g., power failure warning, O2 sensor, flow sensor) .................................................
4.4.1
Power failure alarm, battery circuit ............................................................................
4.4.2
(Option) Total failure alarm ........................................................................................
4.4.3
O2 low alarm .............................................................................................................
4.4.4
Flow sensor failure alarm ..........................................................................................
4.4.5
O2 sensor failure alarm (not applicable in case of monitoring with external O2
measurement) ...........................................................................................................
4.5 Flowmeter test .........................................................................................................................
4.5.1
Comparative flow measurement with external flowmeter block ................................
4.5.2
Safety valve of flowmeter block.................................................................................
4.6 SORC test (not applicable in nitrous oxide-free mode) ...........................................................
4.6.1
N2O shut-off (not applicable in nitrous oxide-free mode) ..........................................
4.6.2
O2 concentration and gas type test (not applicable in nitrous oxide-free mode) ......
4.6.3
SORC function (not applicable in nitrous oxide-free mode) ......................................
4.7 Additional tests ........................................................................................................................
4.7.1
Pressure-limiting valve and auxiliary-air valve ..........................................................
4.7.2
Pmax accuracy..........................................................................................................
4.8 Ventilation modes ....................................................................................................................
4.8.1
Manual ventilation .....................................................................................................
4.8.2
Spontaneous breathing .............................................................................................
4.8.3
Lung ventilator performance......................................................................................
4.8.4
Tightness check of the AGS non-return valve ...........................................................
4.8.5
PEEP pressure accuracy ..........................................................................................
4.9 (Option) Pin index cylinder couplings, pressure gauge and pressure regulator ......................
4.9.1
Cylinder connections, non-return valves, manometers .............................................
4.9.2
Check the pressure regulator for the pin index cylinders ..........................................
4.10 (Option) High-pressure cylinders, high-pressure regulator......................................................
4.10.1 High-pressure cylinders on the gas inlet block (non-return valves)...........................
4.10.2 O2 high-pressure leakage .........................................................................................
4.10.3 N2O high-pressure leakage (not applicable in nitrous oxide-free mode) ..................
4.11 Final procedures ......................................................................................................................
23
23
23
24
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3 / 47
1RB
4.2
25
25
25
26
27
27
28
28
29
29
30
30
30
30
31
31
31
31
31
32
32
32
34
34
35
35
36
36
36
36
37
37
38
38
39
40
41
41
42
42
)DELXVSOXV;/
Table of contents
4.11.1 Device handover........................................................................................................ 42
Test equipment
42
Test equipment subject to mandatory calibration..................................................................... 42
Test equipment not subject to mandatory calibration............................................................... 44
Appendix
47
Ambient pressure..................................................................................................................... 47
1RB
5
5.1
5.2
6
6.1
4 / 47
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Important notes
Important notes
WARNING
Danger due to non-compliance with the documentation
Without exact knowledge of and compliance with this documentation,
carrying out the measures described herein could lead to personal injury,
damage to property, or damage to the environment. Using the product without
exact knowledge of and compliance with the corresponding instructions for
use could lead to personal injury, damage to property, or damage to the
environment.
Ź Make sure that you have the current revision of this documentation. Use
only the current revision of this documentation.
Ź Carefully read and comply with the measures described in this
documentation.
Ź Carefully read and comply with the corresponding instructions for use.
NOTE
All results and inputs must be recorded in the electronic test instructions or in
a printed outcome document.
NOTE
Do not use these test instructions for review after a repair.
NOTE
If the "nitrous-oxide-free anesthesia " upgrade kit is available, no nitrous
oxide-related tests are required.
NOTE
For the devices listed below, the test instructions specific to the relevant
device must be used:
– Vaporizers (e.g., Vapor 2000; Vapor 3000)
– Connected monitoring
– Connected breathing systems
– Silverline pressure reducer
NOTE
Conversions: 1 bar = 14.504 psi / 1 mbar = 1.01973 cmH2O
1
Device configuration
No.2310_0000007539
This chapter contains test steps to document the configuration.
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Maintenance parts
1.1
Basic device configuration
1.1.1
Serial number
NOTE
The serial number of the device is recorded in either the electronic test
instructions or a printed results document.
NOTE
The serial number of the breathing system is located on the side of the
breathing system.
2
Result
Serial number of the breathing system (COSY 2.n)
[________txt]
Result
(Option) Bronchial suction system serial number
[________txt]
Result
(Option) Serial number of the external monitoring device
[________txt]
Maintenance parts
This chapter contains information on maintenance parts, measures and tests.
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 completely replaced
every four years.
NOTE
(Option) Pin index: The kit for the pressure reducer is replaced depending on
the connection version.
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.
Fabius battery set
Lithium battery
Tests
6 / 47
Part number
MX08899
1866249
1
2
3
x
x
4
5
6
7
8
x
x
7HVWLQVWUXFWLRQV6HUYLFH&DUG,30_5HYLVLRQ_
9
x
x
10
11
12
x
x
No.2310_0000007539
Designation
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Maintenance parts
Designation
Part number
-
1
2
3
4
5
O2 input pressure
reducer downstream
x
pressure test
N2O input pressure reg- ulator downstream presx
sure test
Drägersorb CLIC option for disposable absorber
Drägersorb CLIC
MX50090
adapter (MX50090, gray
x
seal)
(Or) Set of seals for
M36045
x
x
x
Drägersorb CLIC
M35381
adapter (MX00012, blue
x
x
seal)
(Or) Set of seals for
MX08000
x
x
x
Drägersorb CLIC
MX08001
adapter (MX00012,
x
x
white seal)
Pin index option. Replace one of the following pressure reducers:
Upgrade kit, N2O pres- 8608799
sure reducer, long
Upgrade kit, N2O pres- 8608800
sure reducer, short
Upgrade kit, O2 pres8608804
sure reducer, short T
Upgrade kit, O2/Air pres- 8608801
sure reducer, long L
Upgrade kit, O2/Air pres- 8608803
sure reducer, short L
India only: Pressure
8608793
reducer "N2O compl RV
long" kit
2.2
Maintenance parts by specified interval
2.2.1
Lithium battery (every 3 years)
6
7
8
9
10
11
12
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
NOTE
Batteries are special waste. Dispose of batteries in accordance with local
waste disposal regulations.
No.2310_0000007539
Quantity
1
Result
Designation
Number
Location/Remark
Lithium battery
1866249
On the Control PCB
Lithium battery
Next replacement: [________dat]
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Maintenance parts
2.2.2
Lead-gel battery (3-yearly)
NOTE
Batteries are special waste. Dispose of batteries in accordance with local
waste disposal regulations.
Quantity
1
Result
Designation
Number
Location/Remark
Fabius battery set
MX08899
In control box
Fabius battery set
Next replacement: [________dat]
2.2.3
Input pressure regulator test (every 3 years)
Prerequisites
2.2.3.1
The pressure regulators are freely accessible.
Test: Downstream pressure of central supply O2 input pressure regulator, every 3
years
2475
Test set-up
Fig. 1
Input pressure regulator test setup
1
2
3
4
5
6
7
8
9
8 / 47
N2O outlet (to the N2O flow control valve)
Gas inlet assembly
N2O input pressure regulator
O2 input pressure regulator
O2 outlet (to the O2 flow control valve)
Plug-in connector (7901458)
To the O2 flow-control valve
To the N2O flow-control valve
Digital manometer (7910724)
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No.2310_0000007539
Item Designation
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Maintenance parts
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.
• Set the O2 flow at the flow control valve to 4 L/min.
Test
The O2 pressure regulator output pressure is 2.2 to 2.6 bar.
Result
Downstream pressure of pipeline supply O2 input pressure regulator
[________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
Test: Downstream pressure of central supply N2O input pressure regulator, every 3
years (not applicable in nitrous-oxide-free mode)
Action
• Remove the N2O pressure tube from the N2O outlet of the gas inlet block
and interconnect the digital pressure gauge. Refer to the previous
illustration.
• Reconnect the central O2 and N2O supply hoses to the central supply
inlets and activate the central supply.
• Set the O2 and N2O flows at the flow control valves to 4 L/min.
Test
Result
The N2P pressure regulator outlet pressure amounts to 2.2 to 2.6 bar.
Downstream pressure, central N2O supply inlet pressure reducer (not
applicable for operation without nitrous oxide)
[________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.
No.2310_0000007539
•
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Maintenance parts
2.2.4
(Option) Drägersorb CLIC
2.2.4.1
Set of seals for Drägersorb CLIC, white seal (annually)
Quantity
1
Result
Designation
Number
Location/Remark
Set of seals
MX08000
Old version of the adapter, rating plate adhered up to ARTNXXXX
Set of seals MX08000, white seal
Next replacement: [________dat]
2.2.4.2
Set of seals for Drägersorb CLIC, blue seal (annually)
Quantity
1
Result
Designation
Number
Location/Remark
Set of seals
M36045
New version of the adapter,
laser-engraved rating plate
Set of seals M36045, blue seal
Next replacement: [________dat]
2.2.4.3
Set of seals for Drägersorb CLIC, white seal (every 2 years)
Quantity
1
Result
Designation
Number
Location/Remark
Set of seals
MX08001
Old version of the adapter,
printed rating plate
Set of seals MX08001, white seal
Next replacement: [________dat]
2.2.4.4
Set of seals for Drägersorb CLIC, blue seal (every 2 years)
Quantity
1
Result
Designation
Number
Location/Remark
Set of seals
M35381
New version of the adapter,
laser-engraved rating plate
Set of seals M35381, blue seal
No.2310_0000007539
Next replacement: [________dat]
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Maintenance parts
2.2.4.5
Drägersorb CLIC adapter, gray seal (every 4 years)
Quantity
1
Result
Designation
Drägersorb CLIC
adapter
Number
MX50090
Location/Remark
Breathing system
Drägersorb CLIC adapter
Next replacement: [________dat]
2.2.5
(Option) Pin index (6-yearly)
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.
– 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.
Replacing the N2O pressure reducer with long non-return valve:
Quantity
1
Result
Designation
Number
Location/Remark
Upgrade kit, N2O
pressure reducer,
long
8608799
On cylinder connection
Upgrade kit, N2O pressure reducer, long
Next replacement: [________dat]
Replacing the N2O pressure reducer with long non-return valve.
Quantity
1
Result
Designation
Number
Location/Remark
Upgrade kit, N2O
pressure reducer,
short
8608800
On cylinder connection
Upgrade kit, N2O pressure reducer, short
Next replacement: [________dat]
Replacing the O2 pressure reducer with short non-return valve and Tconnection.
No.2310_0000007539
Quantity
1
Result
Designation
Number
Upgrade kit, O2 pres- 8608804
sure reducer, short T
Location/Remark
On cylinder connection
Upgrade kit, O2 pressure reducer, short T
Next replacement: [________dat]
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Electrical safety
Replacing the O2/Air pressure reducer with long non-return valve and Lconnection:
Quantity
1
Result
Designation
Number
Location/Remark
Upgrade kit, O2/Air
pressure reducer,
long L
8608801
On cylinder connection
Upgrade kit, O2/Air pressure reducer, long L
Next replacement: [________dat]
Replacing the O2/Air pressure reducer with short non-return valve and Lconnection:
Quantity
1
Result
Designation
Number
Location/Remark
Upgrade kit, O2/Air
pressure reducer,
short L
8608803
On cylinder connection
Upgrade kit, O2/Air pressure reducer, short L
Next replacement: [________dat]
NOTE
This test is only relevant for India.
Replacing the N2O pressure reducer with long non-return valve:
Quantity
1
Result
Designation
Number
"N2O compl RV long" 8608793
pressure reducer kit
Location/Remark
On cylinder connection
N2O pressure reducer kit compl RV long
Next replacement: [________dat]
3
Electrical safety
This chapter contains tests on the electrical safety.
Perform the tests according to IEC 62353 or IEC 60601-1 (depending on the
national guidelines. In Germany, for example, standard DIN EN 62353
applies).
Electrical safety, base unit, to DIN EN 62353 (IEC 62353)
No.2310_0000007539
3.1
Notes
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Electrical safety
NOTE
The device conforms to the conditions of Class I, Type BF.
NOTE
The tester, e.g. SECUTEST, must be correctly configured for all
measurements. If implausible measurement results are obtained, such as a
leakage current of 0.0 μA, check the tester configuration in addition to the test
setup.
NOTE
– In testing to IEC 62353, the medical electrical equipment (ME equipment)
or the medical electrical system (ME system) must be tested.
– ME systems must be treated like ME equipment.
– An ME system is a combination of several devices as specified by the
manufacturer (at least one of these devices must be an ME equipment)
which are interconnected by a functional connection or by a multiple
socket-outlet.
NOTE
With devices that are connected to other devices by means of a data cable,
this connection must be disconnected prior to performing the electrical safety
check, in order to avoid incorrect measurements.
3.1.1
Visual inspection
Prerequisites
Action
The tester and the device under test are switched off.
• Unplug the mains plug from the socket outlet.
WARNING
Risk of electric shock
Touching live components can lead to serious injury or death.
Ź Disconnect the device from the power supply.
• Remove the power fuse links with the power fuses.
Test
– The power fuses 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.
Condition checked
[________OK]
No.2310_0000007539
Result
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Electrical safety
3.1.2
Protective earth resistance
1936
Test set-up
Fig. 2
Protective earth resistance
Item Designation
1
2
3
L
N
PE
Action
Tester
Device under test
Probe cable with test probe
Conductor
Neutral conductor
Protective earth
• Prepare the test setup.
• Switch on the tester.
• Configure the tester appropriately, and follow the instructions on the tester.
• Using the tip of the probe cable, scan each of the measuring points on the
device under test listed under "Protective earth resistance measuring
points" one after the other, moving the power supply cord along the entire
length during the measurement. The resistance must not change when you
do so.
Test
The protective earth resistance of devices with detachable but connected
power supply cords must not exceed 0.3 ȍ in each case.
Result
Maximum measured value of device with power cable
Action
• Move the power supply cord along the entire length during the
measurement. The protective earth resistance must not change when you
do so.
Test
The protective earth resistance must not exceed 0.1 ȍ.
Result
Maximum measured value of optional power cable
Test
[________ȍ]
The protective earth resistance of ME systems, including the power cable,
must not exceed 0.5 ȍ in each case.
Maximum measured value of ME system
[________ȍ]
No.2310_0000007539
Result
[________ȍ]
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Electrical safety
3.1.3
Protective earth resistance measuring points
Action
• Scan the following measuring points for protective earth resistance
measurement 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
3.1.4
Measurement points scanned.
[________OK]
Device leakage current
NOTE
– The device leakage current can be tested according to the differential current or direct measurement method.
– For direct measurement, the device under test must be insulated.
Prerequisites
The tester is switched on.
29258
Test set-up
Fig. 3
Equipment leakage current
No.2310_0000007539
Item Designation
1
2
3
4
5
L
N
PE
Tester
Device under test
Device-specific test adapter for the medical device (applied part)
Probe cable with test probe
Configurable sockets (A-K) for applied parts
Conductor
Neutral conductor
Protective earth
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Electrical safety
Action
• Prepare the test setup.
• Connect the device-specific test adapter to the device under test and to
socket "A" on the test device.
• Follow the instructions on the tester. Connect the tip of the probe cable to a
protective earth resistance measuring point.
NOTE
– The test must be performed twice on symmetrical mains plugs. In the second test the mains plug must be rotated through 180° before being
plugged into 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 initial measured value must be entered in the test report as the reference
value.
Test
Result
The reference value must not exceed 500 μA.
Reference value
[________μA]
NOTE
If the measured values are between 90% and 100% of the permissible limit
value, the reference value and the previously measured recurrent
measurement values must be applied to assess electrical safety.
Test
Result
3.2
The recurrent test value must not exceed 500 μA.
Recurrent test
[________μA]
(Option) Electrical safety, power supply unit COSY 2.n heater in
accordance with DIN EN 62353 (IEC 62353)
NOTE
The device conforms to the conditions of protection class I, type B.
3.2.1
Visual inspection
Prerequisites
Action
The tester and the device under test are switched off.
• Unplug the mains plug from the socket outlet.
WARNING
• Remove the power fuse links with the power fuses.
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No.2310_0000007539
Risk of electric shock
Touching live components can lead to serious injury or death.
Ź Disconnect the device from the power supply.
)DELXVSOXV;/
Electrical safety
Test
– The power fuses 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
3.2.2
Condition checked
[________OK]
Protective earth resistance
1936
Test set-up
Fig. 4
Protective earth resistance
Item Designation
1
2
3
L
N
PE
Action
Tester
Device under test
Probe cable with test probe
Conductor
Neutral conductor
Protective earth
• Prepare the test setup.
• Switch on the tester.
• Configure the tester appropriately, and follow the instructions on the tester.
• Using the tip of the probe cable, scan each of the measuring points on the
device under test listed under "Protective earth resistance measuring
points" one after the other, moving the power supply cord along the entire
length during the measurement. The resistance must not change when you
do so.
Test
Result
Test
Result
No.2310_0000007539
3.2.3
The protective earth resistance of devices with detachable but connected
power supply cords must not exceed 0.3 ȍ in each case.
Maximum measured value of device with power cable
[________ȍ]
The protective earth resistance of ME systems, including the power cable,
must not exceed 0.5 ȍ in each case.
Maximum measured value of ME system
[________ȍ]
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.
_5HYLVLRQ_7HVWLQVWUXFWLRQV6HUYLFH&DUG,30
[________OK]
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Electrical safety
3.2.4
Device leakage current
NOTE
– The device leakage current can be tested according to the differential current or direct measurement method.
– For direct measurement, the device under test must be insulated.
Prerequisites
The tester is switched on.
29258
Test set-up
Fig. 5
Equipment leakage current
Item Designation
1
2
3
4
5
L
N
PE
Action
Tester
Device under test
Device-specific test adapter for the medical device (applied part)
Probe cable with test probe
Configurable sockets (A-K) for applied parts
Conductor
Neutral conductor
Protective earth
• Prepare the test setup.
• Connect the device-specific test adapter to the device under test and to
socket "A" on the test device.
• Follow the instructions on the tester. Connect the tip of the probe cable to a
protective earth resistance measuring point.
NOTE
– The test must be performed twice on symmetrical mains plugs. In the second test the mains plug must be rotated through 180° before being
plugged into the socket. In many test devices the mains plug rotation is
simulated by means of a built-in selector switch.
NOTE
The initial measured value must be entered in the test report as the reference
value.
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No.2310_0000007539
– The higher measured value must be documented.
)DELXVSOXV;/
Electrical safety
Test
Result
The reference value must not exceed 500 μA.
Reference value
[________μA]
NOTE
If the measured values are between 90% and 100% of the permissible limit
value, the reference value and the previously measured recurrent
measurement values must be applied to assess electrical safety.
Test
Result
3.3
The recurrent test value must not exceed 500 μA.
Recurrent test
[________μA]
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
additional sockets.
NOTE
The following tests are based on testing with the SECUTEST tester. This
tester allows simulation of the power plug rotation. With other testers, it may
be necessary to rotate it manually (the higher measured value shall be
documented).
In the case of devices connected to other devices by a data cable, this
connection 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.
Base unit
[________OK]
No.2310_0000007539
Result
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Electrical safety
3.3.2
Protective earth resistance
1629
Test set-up
Action
Fig. 6
Test setup for the protective earth conductor
Item
1
2
3
L
N
PE
Designation
Tester, e.g. SECUTEST, 7910594
Fabius under test
Test probe with tip (e.g. SECUTEST accessories)
Conductor
Neutral conductor
(Protective earth) conductor
• 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
Result
3.3.3
The protective earth resistance must not exceed 0.2 Ohm (including mains
power cable) in each case.
Protective earth resistance
[________ȍ]
Earth leakage current
Test set-up
Set up the Fabius so that it is insulated.
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No.2310_0000007539
NOTE
)DELXVSOXV;/
1631
Electrical safety
Action
Test
Result
Test
3.3.4
Fig. 7
Earth leakage current test setup
Item
1
2
L
N
PE
Designation
Tester, e.g. SECUTEST, 7910594
Fabius under test
Conductor
Neutral conductor
(Protective earth) conductor
• Prepare the test setup.
In normal condition (N.C.), the value must not exceed 500 μA.
Normal condition (N.C.)
[________μA]
In single fault condition (S.F.C.), the value must not exceed 1000 μA.
Result
Single fault condition (S.F.C.)
Action
• Switch off the SECUTEST and the Fabius.
[________μA]
(Option) Power supply unit COSY 2.n heater, protective earth resistance
No.2310_0000007539
1629
Test set-up
Fig. 8
Test setup for the protective earth conductor
Item
1
2
3
L
N
PE
Designation
Tester, e.g. SECUTEST, 7910594
Heater power supply unit under test
Test probe with tip (e.g. SECUTEST accessories)
Conductor
Neutral conductor
(Protective earth) conductor
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Function and condition test
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
Result
3.3.5
The protective earth resistance must not exceed 0.2 Ohm (including mains
power cable) in each case.
Protective earth resistance
[________ȍ]
(Option) Power supply unit COSY 2.n heater, earth leakage current
Test set-up
NOTE
1631
Set up the Fabius so that it is insulated.
Action
Test
Result
Test
Earth leakage current test setup
Item
1
2
L
N
PE
Designation
Tester, e.g. SECUTEST, 7910594
Heater power supply unit under test
Conductor
Neutral conductor
(Protective earth) conductor
• Prepare the test setup.
In normal condition (N.C.), the value must not exceed 500 μA.
Normal condition (N.C.)
In single fault condition (S.F.C.), the value must not exceed 1000 μA.
Result
Single fault condition (S.F.C.)
Action
• Switch off the SECUTEST and the heater power supply unit.
[________μA]
Function and condition test
This chapter contains condition and function tests.
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No.2310_0000007539
4
Fig. 9
)DELXVSOXV;/
Function and condition test
4.1
Base unit
Prerequisites
4.1.1
The device is fully assembled.
Labels and instructions for use
Test
The labels and letterings are complete and legible.
The instructions for use are available, according to the user/owner.
Result
4.1.2
Condition checked.
[________OK]
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
4.1.3
Result
Check tubing, tube fittings and colour coding for perfect condition.
Condition and function checked.
[________OK]
Condition and function of vaporizer mount and interlock
Test
Result
4.2
[________OK]
Tubing (PAE, PA, fabric-reinforced)
Test
4.1.4
Condition and function of base unit checked.
Vapor anesthetic vaporizer mount and interlock
Condition and function checked.
[________OK]
Self-test, calibration and tightness of the main device
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
No.2310_0000007539
Test
• Set the main switch of the device to “ON”.
Check whether Fabius performs the self-test and all tests are displayed as
“passed”.
Result
Entering the software version
[________txt]
Result
Self-test successfully completed.
[________OK]
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Function and condition test
4.2.2
O2 sensor calibration (not applicable in case of monitoring with external O2
measurement)
Prerequisites
The device is in standby mode.
Action
• Press the "O2 sensor calibr." key and follow the on-screen instructions.
Test
As soon as the calibration is completed, check whether the message "O2
sensor error" has disappeared and the calibration was successful.
Result
O2 sensor calibrated
Action
• Press the "Home" key to access the standby screen.
[________OK]
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.
2551
– Use test adapter 7900138 to perform the measurements directly at the
fresh gas outlet instead of at the COSY2 (see illustration).
Fig. 10
Test setup for O2 sensor calibration
Item Designation
O2 sensor
Adapter top M27961
Test adapter 7900138
Tube
Kuhn connector M28189
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.
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No.2310_0000007539
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2
3
4
5
6
)DELXVSOXV;/
Function and condition test
Test
Result
Action
The O2 concentration is 97 to 100% within 3 minutes.
O2 concentration
[________%]
• 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
4.2.4
At completion of calibration verify "Flow Calibration Completed" message
appears.
Result
Flow sensor calibration
Action
• Press the "Home" key to return to the Standby screen.
Action
• Reconnect the expiratory tube to the expiratory connection of the breathing
system.
[________OK]
Tightness check of the breathing system
Introduction
NOTE
For all subsequent measurements it is important to note that the pressure in
the COSY 2.n must not exceed 80 mbar. An optional pressure gage could be
destroyed.
Action
• Fully equip the breathing system.
• Access the standby screen.
• Press the “Leak/Compl.Test” key in the standby screen.
• Follow the on-screen instructions.
Test
4.2.5
The tightness check was completed without any issues.
Result
Tightness check of the breathing system
Action
• Press the "Home" key to access the standby screen.
[________OK]
Fresh gas leakage test passive (with and without vaporizer)
NOTE
No.2310_0000007539
Carry out this test once with the vaporizer fitted and once without vaporizer.
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Function and condition test
1407
Test set-up
Fig. 11
Fresh gas leakage, shown on Fabius GS by way of example
Item Designation
1
2
3
Action
Digital pressure gauge 7910722
Fresh gas hose
Kuhn grommet M28189
• Connect the device to the central supply.
• Close any cylinders on the Fabius.
• Unscrew the fresh gas hose from the COSY 2.n breathing system or (if the
A-cone option is installed) from the A-cone.
• Close all flow control valves.
• Connect a Kuhn grommet and a digital pressure gauge to the fresh-gas
outlet.
Test
Result
Action
No pressure is displayed on the digital pressure gauge.
Tightness of the flow control valves
[________OK]
• 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
4.2.6
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]
(Option) Operation without nitrous oxide: Fresh gas leakage passive test
NOTE
No.2310_0000007539
Carry out this test without the Vapor connected.
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Function and condition test
1407
Test set-up
Fig. 12
Fresh gas leakage, shown on Fabius GS by way of example
Item Designation
1
2
3
Action
Digital manometer 7910722
Fresh gas tube
Kuhn connector M28189
• 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
Result
Action
If the leakage is less than 0.1 L/min, a pressure greater than 35 mbar can be
built up on the digital manometer.
Fresh gas leakage
[________OK]
• 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.
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]
Action
• Use the rotary knob to navigate to the "Main Service Screen".
No.2310_0000007539
4.3.1
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Function and condition test
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
ventilator hose from breathing system. Expose to air.
Disconnect the pressure measuring
line and the ventilator tube from the
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.
Action
• Press the "Exit" key.
[________OK]
• 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 pressure gauge (7910722) to the tubing connection (large
diameter) for the APL valve on the breathing system.
Test
Action
The displayed pressure lies between -180 and -220 mbar.
• If the values are not reached, press the "Pump Cal." key.
• If the values are still not reached, calibrate the pump and pump output to
Ppump 200 ± 10 mbar in accordance with the repair instructions.
Action
• Loosen the fan cover.
Result
The measured pump pressure rises to approximately ambient pressure. [________OK]
Action
• Close the fan cover again.
Test
Result
Action
28 / 47
The displayed pressure lies between -180 and -220 mbar.
The displayed pressure lies between -180 and -220 mbar again.
Vacuum test and pump calibration completed (key background is
white).
• Press the rotary knob to access the "Main Service Screen".
7HVWLQVWUXFWLRQV6HUYLFH&DUG,30_5HYLVLRQ_
[________OK]
No.2310_0000007539
Test
)DELXVSOXV;/
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 breathing 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
Result
Action
Verify "PEEP Calibration" indicates "pass".
PEEP valve calibration complete.
[________OK]
• 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 the O2 cell into the sensor
Reinstall O2 cell in sensor housing
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.
Action
• Reassemble the O2 sensor housing, and then install the O2 sensor
housing onto the inspiratory dome of the breathing system.
[________OK]
• Press the "Exit" key.
No.2310_0000007539
• Press the rotary knob to access the "Main Service Screen".
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Function and condition test
4.4
Alarms (e.g., power failure warning, O2 sensor, flow sensor)
Prerequisites
4.4.1
The device is switched on.
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
disappears.
Result
4.4.2
Power failure alarm, battery circuit
[________OK]
(Option) Total failure alarm
Prerequisites
Action
The device was manufactured in the production period starting August 2008.
• Remove the battery fuse in standby mode.
• Pull the power plug.
Test
Check if the acoustic total failure alarm signal sounds for at least 30 seconds.
Mount the battery fuse, plug the power plug in and check if the acoustic total
failure alarm signal stops.
Result
4.4.3
Total failure alarm
[________OK]
O2 low alarm
NOTE
If not already selected, in Service mode under Configure > Standard
Options > O2-Whistle, set Enable .
Action
• Connect the O2 pipeline supply tube to the gas manifold 7901495.
• Set the O2 flow to 0.5 L/min.
• Open and close the O2 cylinder valve.
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 lights up.
Result
At which pressure does the message appear?
Action
• Bleed the remaining O2 pressure from the system, and close the flow
control valve.
• Remove the gas manifold from the device and reconnect the pipeline
supply tubes.
NOTE
Reset "O2 whistle" to customer settings.
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[________bar]
No.2310_0000007539
Test
)DELXVSOXV;/
Function and condition test
4.4.4
Flow sensor failure alarm
Action
Test
Action
• Disconnect the flow-sensor cable from the breathing system.
The "FLOW SENSOR ERROR !" message appears and an audible alarm
sounds.
• Connect the flow-sensor cable to the breathing system.
• Calibrate the flow sensor.
Result
4.4.5
The "FLOW SENSOR ERROR !" message has disappeared.
[________OK]
O2 sensor failure alarm (not applicable in case of monitoring with external O2
measurement)
Action
Test
• Disconnect the O2 sensor cable from the rear of the Fabius.
The "O2 SENSOR ERROR !" message appears and an audible alarm
sounds.
Make sure that the O2 sensor has stabilized in ambient air for several
minutes.
Action
• Re-attach the O2 sensor cable.
• Calibrate O2 sensor.
Result
4.5
The "O2 SENSOR ERROR !" message has disappeared.
[________OK]
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
Result
4.5.2
The measured values (O2, AIR, N2O) are within a tolerance of +/-10%.
Tests within tolerances.
[________OK]
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.
No.2310_0000007539
Test
Result
The safety valve opens at a pressure of less than less than/equal to
900 mbar.
Tests within tolerance.
_5HYLVLRQ_7HVWLQVWUXFWLRQV6HUYLFH&DUG,30
[________OK]
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Function and condition test
4.6
SORC test (not applicable in nitrous oxide-free mode)
Introduction
These instructions describe the SORC 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
4.6.2
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]
O2 concentration and gas type test (not applicable in nitrous oxide-free mode)
Fabius is in “Man/Spont” ventilation mode.
No.2310_0000007539
Prerequisites
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Function and condition test
2551
Test set-up
Fig. 13
Test setup for O2 sensor calibration
Item Designation
1
2
3
4
5
6
Action
O2 sensor
Adapter top M27961
Test adapter 7900138
Tube
Kuhn connector M28189
Fresh gas tube
• Prepare the O2 sensor calibration test setup.
• Connect the Air pipeline supply.
• Set the Air flow control valve to 4 L/min.
Test
Action
Test
Air pipeline supply manometer indicates pipeline pressure.
• Open the O2 and N2O flow control valves.
The O2 and N2O manometers indicate no pressure.
Result
Air pipeline supply manometer indicates pipeline pressure
Test
The O2 and N2O flow on the flowmeter block is equal to 0 L/min.
Result
Action
No O2 or N2O flow
[________OK]
[________OK]
• 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.
No.2310_0000007539
Result
Test
Result
O2 pipeline supply manometer indicates pipeline pressure.
[________OK]
Air and N2O flow equal to 0 L/min.
No Air or N2O flow
_5HYLVLRQ_7HVWLQVWUXFWLRQV6HUYLFH&DUG,30
[________OK]
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Function and condition test
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
Test
Result
4.6.3
O2 concentration
[________OK]
Air flow equal to 0 L/min.
No Air flow
[________OK]
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
concentration.
• 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
O2 concentration
Action
• Reduce the O2 flow to 0.5 L/min.
Test
N2O flow
Action
• Reduce the O2 flow to zero.
Test
Test
[________OK]
The N2O flow is greater than/equal to 0.6 L/min.
Result
Action
4.7
The O2 concentration at each of the above value settings is 23% or higher.
Result
[________L/min]
The reading on the N2O flowmeter is equal to 0 L/min.
• Slowly increase the O2 flow until there is no more N2O flow left.
N2O starts flowing at an O2 flow of 0.13 to 0.27 L/min.
Result
O2 flow
Action
• Close the O2 and N2O flow control valves.
[________L/min]
Additional tests
Prerequisites
The device is switched on, has successfully completed the self-test, and is in
"Standby" mode.
No.2310_0000007539
The breathing system is fitted.
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Function and condition test
4.7.1
Pressure-limiting valve and auxiliary-air valve
1438
Test set-up
Fig. 14
Test setup for the pressure-limiting valve
Item Designation
1
2
Action
Test connector M13506
Digital manometer 7910722
• 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.
No.2310_0000007539
• Prepare the test setup.
4.7.2
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.
Pmax accuracy
Action
• Set ventilation mode IPPV (VC).
• Connect a manometer (7910722) to the Y-piece.
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Function and condition test
Test
Verify the test manometer readout and the airway pressure values for the
following Pmax settings:
Pmax setting
25
70
Result
4.8
Displayed value (mbar)
20 to 30
65 to 75
Pmax accuracy
[________OK]
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
Result
4.8.2
Manual ventilation
[________OK]
Spontaneous breathing
Action
Test
4.8.3
Manual ventilation can be applied by squeezing the manual breathing bag.
• Set the APL valve to SPONT.
Spontaneous breathing with the connected test lung is possible.
Result
Spontaneous breathing
Action
• Close the O2 flow control valve.
[________OK]
Lung ventilator performance
Action
• Switch to IPPV (VC) mode.
• Press the flush button briefly to inflate the bag.
• Adjust the following values:
pmax = 70 mbar
Vt = 380 mL
Freq = 12 BPM
TI:TE = 1:1
TIP:TI = 10%
• Confirm settings with the rotary knob.
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No.2310_0000007539
PEEP = 0 mbar
)DELXVSOXV;/
Function and condition test
Test
IPPV (VC) mode is indicated.
Ventilation starts.
The ventilator is running quietly and smoothly.
Result
Test
Result
4.8.4
Ventilator is running quietly and smoothly
[________OK]
Volume delivery Vte 300 to 450 mL
Volume delivery
[________mL]
Tightness check of the AGS non-return valve
Prerequisites
Action
The existing parameters remain set.
• Briefly press the Flush button to fill the breathing bag.
• Set the following values:
– Fresh gas flow = 1 L/min
– Vt = 600 mL
In volume-controlled ventilation mode "IPPV / VC / Vol. Cont.", the breathing
bag remains visibly filled (Fig. 15/A) and spontaneous breaths can be seen.
47044
Test
Fig. 15
Result
Breathing bag (A: Test result OK, B: Test result not OK)
Tightness check of the AGS non-return valve
[________OK]
NOTE
If the test is not passed (Fig. 15/B), perform the following action.
Action
4.8.5
PEEP pressure accuracy
Action
No.2310_0000007539
• If the breathing bag slowly collapses in on itself over several spontaneous
breaths and does not remain full (Fig. 15/B), replace the AGS non-return
valve.
Test
• After 10 breaths, press the PEEP parameter button, and then enter the
listed "PEEP setting" values.
Check the displayed values for the following PEEP settings:
PEEP setting
0
5
_5HYLVLRQ_7HVWLQVWUXFWLRQV6HUYLFH&DUG,30
Displayed value (mbar)
0 to 2
3 to 7
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Function and condition test
PEEP setting
15
4.9
Action
• Return the PEEP setting to zero and confirm.
Result
PEEP pressure accuracy
[________OK]
(Option) Pin index cylinder couplings, pressure gauge and pressure
regulator
Introduction
4.9.1
Displayed value (mbar)
12 to 18
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.
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
Action
Condition of cylinder connections checked.
[________OK]
• Set the main switch of the device to OFF.
• Disconnect all central supply hoses.
• Connect a cylinder to each cylinder connection and open the cylinder
valve.
• Only perform the following action if non-return valves are installed: wait for
pressure equalization, close the cylinder valve and remove the cylinders
from the cylinder connection assembly.
Test
The cylinder pressure gauge on the front of the Fabius displays the
corresponding cylinder pressure as shown on the gas type label.
Result
No leakage is detectable.
Action
• Bleed all pressure from the cylinder circuits using the flow control valves.
Test
[________OK]
The cylinder manometers indicate 0 bar/psi.
Function of non-return valve and manometer
Action
• Connect the cylinders and open the valves one after the other.
[________OK]
No.2310_0000007539
Result
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Function and condition test
4.9.2
Check the pressure regulator for the pin index cylinders
1411
Test set-up
Fig. 16
Pressure regulator test setup
Item Designation
1
2
3
4
5
Test cylinder
Test pressure regulator 7901482
Test adapter 7901495
Device inlet
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
25 bar to 110 bar
110 bar to 200 bar
Pressure regulator output tolerance
2.0 bar to 2.8 bar
1.8 bar to 2.6 bar
Result
O2 pressure regulator
Action
• Close the flow control valves.
[________OK]
No.2310_0000007539
N2O 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 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)
Action
• Close the flow control valves.
[________OK]
Air pressure regulator
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
4.10
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
Action
• Close the flow control valves.
[________OK]
(Option) High-pressure cylinders, high-pressure regulator
Introduction
These instructions describe the procedures for testing the non-return valves
and leak testing for the optional O2 or N2O high-pressure cylinders.
No.2310_0000007539
The high-pressure cylinder connections are located on the gas inlet block of
the Fabius.
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Function and condition test
4.10.1
High-pressure cylinders on the gas inlet block (non-return valves)
1496
Test set-up
Fig. 17
Pipeline supply test setup, non-return valves
Item Designation
1
2
3
Action
Flowmeter (7901161)
Connecting sleeve (M13506)
Reducing sleeve (7900034) / N2O adapter / Air adapter
• 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
connectors on the gas inlet block.
• Open the relevant O2/N2O high-pressure cylinder.
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.
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.
[________mL/min]
• 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
cylinder connectors on the gas inlet block.
Test
4.10.2
O2 high-pressure cylinder connector max. 5 mL/min.
Result
N2O high-pressure cylinder connector (not applicable in nitrous oxidefree mode) max. 5 mL/min.
[________mL/min]
[________mL/min]
O2 high-pressure leakage
Action
No.2310_0000007539
The flow rate indicated on the flowmeter (1) is less than/equal to 5 mL/min.
Result
• 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.
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Test equipment
Test
Result
4.10.3
The pressure loss must not exceed 10 bar/min.
O2 pressure loss is within tolerance.
[________OK]
N2O high-pressure leakage (not applicable in nitrous oxide-free mode)
Action
• Disconnect the central supply hoses from the gas inlet block.
• Ensure that Fabius is switched off at the main switch.
• Open the N2O cylinder valve and wait for the pressure to stabilize.
• Close the N2O cylinder valve.
• Observe the N2O cylinder pressure gauge.
4.11
Test
The pressure loss must not exceed 10 bar/minute.
Result
The N2O pressure loss is within the tolerance.
[________OK]
Final procedures
Prerequisites
– The test instructions have been performed as specified.
– All tests performed were passed successfully.
4.11.1
5
Device handover
Action
• Hand over the device to the user or operator.
Result
Device handover
[________OK]
Test equipment
This section sets out the test equipment required for the tests in this test
procedure.
5.1
Test equipment subject to mandatory calibration
NOTE
No.2310_0000007539
Tests must be carried out with tests equipment that is calibrated in the
appropriate way.
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Test equipment
Part number
7910594 or equivalent
O2 test pressure regulator
7901482 or equivalent
Flowmeter block 0-250 mL
7901161 or equivalent
Digital manometers
7910722 and 7910724 or
equivalent
No.2310_0000007539
Designation
Measuring equipment for electrical
safety
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Test equipment
Designation
Stopwatch
Part number
7911336
Flowmeter
7900718 or equivalent
Result
5.2
Valid calibrated test equipment used.
[________OK]
Test equipment not subject to mandatory calibration
Part number
M27964 or equivalent
ISO connector
M25647 or equivalent
Test adapter
7900138 or equivalent
No.2310_0000007539
Designation
Plug-in adapter
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Test equipment
Part number
7911140 or equivalent
Rubber plug
1 x 7901297, 2 x 7901665,
7901298 or equivalent
Blower ball
M16118 or equivalent
Kuhn connector
M28189 or equivalent
Connecting sleeve
M13506 or equivalent
Reducing sleeve
7900034 or equivalent
No.2310_0000007539
Designation
Test lung
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Test equipment
Part number
7901495 or equivalent
Adapter top
M27961
Housing front part
6803596 or equivalent
T-connector
6800187 or 2M12754
PU tube, 2.7 mm
1194925
Plastic-jaw pliers
7910296 or equivalent
No.2310_0000007539
Designation
Gas distributor
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Appendix
Designation
Adjustable pin-type face wrench
Part number
7911784 or equivalent
Wrench, 3/8 in
Breathing bag, 3-litre
Tube, corrugated, 22 mm x 12 in. long.
6
Appendix
This section contains further information which may be helpful in testing the
device.
No.2310_0000007539
6.1
Ambient pressure
Altitude range (feet)
Altitude range (metres)
-200 to +199
200 to 599
600 to 999
1000 to 1399
1400 to 1799
1800 to 2199
2200 to 2599
2600 to 2999
3000 to 3399
3400 to 3799
3800 to 4199
4200 to 4599
4600 to 4999
5000 to 5399
5400 to 5799
5800 to 6199
6200 to 6599
6600 to 6999
7000 to 7399
7400 to 7799
7800 to 8199
8200 to 8599
8600 to 8999
9000 to 9399
-60 to +60
61 to 182
183 to 304
305 to 426
427 to 548
549 to 670
671 to 792
793 to 914
915 to 1036
1037 to 1158
1159 to 1280
1281 to 1401
1402 to 1523
1524 to 1645
1646 to 1767
1768 to 1889
1890 to 2011
2012 to 2133
2134 to 2255
2256 to 2377
2378 to 2499
2500 to 2620
2621 to 2742
2743 to 2864
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Barometric pressure setting
(hPa/mbar)
1000
985
970
960
945
930
920
905
890
880
865
855
840
830
820
805
795
785
770
760
750
740
730
47 / 47
Test Documents
6.2
150
Result Sheet Test instructions / Service Card IPM
Technical Documentation IPM | Fabius plus XL
Result Sheet Test instructions / Service Card IPM
Fabius plus XL
Part number:
Location:
Serial number:
Department:
Cust. invent. no.:
Maintenance interval:
Other / Delivery date:
Key
Applies to Test instructions / Service Card IPM Revision 4.0
Test
Serial number
1.1.1.1
Serial number of the breathing system (COSY
2.n)
txt
1.1.1.2
(Option) Bronchial suction system serial number
txt
1.1.1.3
(Option) Serial number of the external monitoring device
txt
Maintenance intervals, overview
2.2
Maintenance parts by specified interval
Lithium battery (every 3 years)
dat
2.2.2
Lead-gel battery (3-yearly)
dat
Input pressure regulator test (every 3 years)
2.2.3.1
Next test
2.2.3.2
2.2.4
dat
2.2.4.2
Set of seals for Drägersorb CLIC, blue seal
(annually)
dat
2.2.4.3
Set of seals for Drägersorb CLIC, white seal
(every 2 years)
dat
2.2.4.4
Set of seals for Drägersorb CLIC, blue seal
(every 2 years)
dat
Drägersorb CLIC adapter, gray seal (every 4
years)
dat
Upgrade kit, N2O pressure reducer, long
dat
2.2.5.2
Upgrade kit, N2O pressure reducer, short
dat
2.2.5.3
Upgrade kit, O2 pressure reducer, short T
dat
2.2.5.4
Upgrade kit, O2/Air pressure reducer, long L
dat
2.2.5.5
Upgrade kit, O2/Air pressure reducer, short L
dat
2.2.5.6
N2O pressure reducer kit compl RV long
dat
Visual inspection
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OK
Device leakage current
3.1.4.1
Reference value
—A
3.1.4.2
Recurrent test
—A
(Option) Electrical safety, power supply unit COSY
2.n heater in accordance with DIN EN 62353 (IEC
62353)
OK
Visual inspection
OK
Protective earth resistance
Maximum measured value of device with power cable
ȍ
3.2.2.2
Maximum measured value of ME system
ȍ
3.2.3
Protective earth resistance measuring points
OK
Device leakage current
3.2.4.1
Reference value
—A
3.2.4.2
Recurrent test
—A
Electrical safety according to IEC 60601-1
3.3.1
Base unit
OK
3.3.2
Protective earth resistance
ȍ
Earth leakage current
3.3.3.1
Normal condition (N.C.)
—A
3.3.3.2
Single fault condition (S.F.C.)
—A
3.3.4
3.3.5
(Option) Power supply unit COSY 2.n heater, protective earth resistance
ȍ
(Option) Power supply unit COSY 2.n heater, earth
leakage current
3.3.5.1
Normal condition (N.C.)
—A
3.3.5.2
Single fault condition (S.F.C.)
—A
4 Function and condition test
Base unit
4.1.1
Labels and instructions for use
OK
4.1.2
Condition and function of the base unit
OK
4.1.3
Tubing (PAE, PA, fabric-reinforced)
OK
4.1.4
Condition and function of vaporizer mount and interlock
OK
4.2
Self-test, calibration and tightness of the main device
4.2.1
Electrical safety, base unit, to DIN EN 62353 (IEC
62353)
3.1.1
Maximum measured value of ME system
Protective earth resistance measuring points
4.1
(Option) Pin index (6-yearly)
2.2.5.1
3 Electrical safety
3.1
3.1.2.3
3.1.3
3.3.3
dat
2.2.5
ȍ
3.3
Set of seals for Drägersorb CLIC, white seal
(annually)
2.2.4.5
Maximum measured value of optional power
cable
3.2.4
OK
(Option) Drägersorb CLIC
2.2.4.1
3.1.2.2
3.2.1
OK
dat
Next test
ȍ
3.2.2.1
Test: Downstream pressure of central supply
N2O input pressure regulator, every 3 years
(not applicable in nitrous-oxide-free mode)
Downstream pressure, central N2O supply inlet pressure
reducer (not applicable for operation without nitrous oxide)
= Not applicable
Maximum measured value of device with power cable
3.2.2
Test: Downstream pressure of central supply
O2 input pressure regulator, every 3 years
Downstream pressure of pipeline supply O2 input pressure regulator
= Accessory not available
-
3.1.2.1
3.2
2.2.1
2.2.3
= Error / Report
/
Protective earth resistance
3.1.4
2 Maintenance parts
2.1
!
Result
3.1.2
Basic device configuration
1.1.1
= OK
= Spare part used
Test
Result
1 Device configuration
1.1
9 / OK
+
Self-test/system diagnostics of the base unit
4.2.1.1
Entering the software version
txt
4.2.1.2
Self-test successfully completed.
OK
4.2.2
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O2 sensor calibration (not applicable in case of
monitoring with external O2 measurement)
Test
Result
4.2.2.1
Test
OK
Result
4.9.1
Cylinder connections, non-return valves, manometers
4.2.2.2
O2 concentration
%
4.2.3
Flow sensor calibration
OK
4.9.1.1
Cylinder connections
OK
4.2.4
Tightness check of the breathing system
OK
4.9.1.2
Leak
OK
4.9.1.3
Non-return valve and manometer
OK
4.2.5
Fresh gas leakage test passive (with and without
vaporizer)
4.9.2
Check the pressure regulator for the pin index cylinders
4.2.5.1
Tightness of the flow control valves
OK
4.2.5.2
Fresh gas leakage with vaporizer
OK
4.9.2.1
O2 pressure regulator
OK
4.2.5.3
Fresh gas leakage without Vapor.
OK
4.9.2.2
N2O pressure regulator (not applicable in nitrous-oxide-free mode)
OK
4.9.2.3
Air pressure regulator
OK
4.2.6
4.3
(Option) Operation without nitrous oxide: Fresh
gas leakage passive test
OK
4.10 (Option) High-pressure cylinders, high-pressure regulator
Service data and basic unit calibration
4.3.1
Service data
4.10.1 High-pressure cylinders on the gas inlet block
(non-return valves)
4.3.1.1
last service date
dat
4.3.1.2
next due service date
dat
4.10.1.1
O2 pipeline supply connection
mL/min
OK
4.10.1.2
N2O pipeline supply connection (not applicable in nitrous oxide-free mode)
mL/min
4.3.2
4.3.3
Pressure
Pump calibration and vacuum test
4.3.3.1
Ambient pressure
OK
4.10.1.3
O2 high-pressure cylinder connector
mL/min
4.3.3.2
Vacuum test and pump calibration completed
OK
4.10.1.4
N2O high-pressure cylinder connector (not applicable in nitrous oxide-free mode)
mL/min
4.3.4
PEEP calibration
OK
4.3.5
O2 offset (not applicable to external O2 measurement)
OK
4.4
Alarms (e.g., power failure warning, O2 sensor, flow
sensor)
4.10.2 O2 high-pressure leakage
OK
4.10.3 N2O high-pressure leakage (not applicable in nitrous oxide-free mode)
OK
4.11 Final procedures
4.4.1
Power failure alarm, battery circuit
OK
4.4.2
(Option) Total failure alarm
OK
4.11.1 Device handover
OK
5 Test equipment
5.1 Test equipment subject to mandatory calibration
4.4.3
O2 low alarm
bar
4.4.4
Flow sensor failure alarm
OK
5.2
4.4.5
O2 sensor failure alarm (not applicable in case of
monitoring with external O2 measurement)
OK
6 Appendix
4.5
6.1
OK
Test equipment not subject to mandatory calibration
Ambient pressure
Flowmeter test
4.5.1
Comparative flow measurement with external
flowmeter block
OK
4.5.2
Safety valve of flowmeter block
OK
4.6
SORC test (not applicable in nitrous oxide-free
mode)
4.6.1
4.6.2
N2O shut-off (not applicable in nitrous oxide-free
mode)
OK
O2 concentration and gas type test (not applicable
in nitrous oxide-free mode)
4.6.2.1
Air pipeline supply manometer indicates pipeline pressure
4.6.2.2
No O2 or N2O flow
OK
4.6.2.3
O2 pipeline supply manometer indicates pipeline pressure.
OK
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
OK
SORC function (not applicable in nitrous oxidefree mode)
4.6.3.1
O2 concentration
4.6.3.2
N2O flow
L/min
4.6.3.3
O2 flow
L/min
4.7
OK
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
4.9
O2 sensor calibrated
Lung ventilator performance
4.8.3.1
Ventilator is running quietly and smoothly
4.8.3.2
Volume delivery
OK
mL
4.8.4
Tightness check of the AGS non-return valve
OK
4.8.5
PEEP pressure accuracy
OK
(Option) Pin index cylinder couplings, pressure
gauge and pressure regulator
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Manufacturer
Draeger Medical Systems, Inc.
3135 Quarry Road
Telford, PA 18969
USA
(215) 721-5400
(800) 4DRAGER
(800 437-2437)
9036821 – 5330.470 en
© Drägerwerk AG & Co. KGaA
Revision: 5.0 –
Subject to change without notice.
Will not be replaced in the event of modifications.
Á9036821CÈ