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Fabius Plus TD 9036798 en
Fabius Plus TD 9036798 en
Fabius plus
Inhalation Anesthesia Machine
Warning
No.3103_0000001949
Table of contents
General 5
1 General notes ........................................................................................................................... 6
Function descriptions 9
1 System overview ...................................................................................................................... 10
2 Leak test ................................................................................................................................... 13
3 Ventilation modes ..................................................................................................................... 15
Function descriptions pneumatic assembly 23
1 Ventilator .................................................................................................................................. 24
2 Pneumatic assembly ................................................................................................................ 28
3 Function description of the gas box .......................................................................................... 30
4 SORC (Sensitive Oxygen Ratio Controller) .............................................................................. 32
5 Cosy 2.6 breathing system ....................................................................................................... 34
6 Anaesthetic vaporizer ............................................................................................................... 37
7 Semi-open adapter ................................................................................................................... 38
8 Wall-mounted unit..................................................................................................................... 42
Function descriptions - Electronics 45
1 Control PCB.............................................................................................................................. 46
2 Electrical block diagram............................................................................................................ 47
3 Control unit ............................................................................................................................... 48
4 Battery backup.......................................................................................................................... 50
5 FiO2 measurement ................................................................................................................... 51
6 Respiratory Flow Measurement................................................................................................ 53
Parts catalog and test instructions 55
1 Parts catalog............................................................................................................................. 56
2 Test Instructions / Service Card IPM ........................................................................................ 115
3 Result Sheet Test instructions / Service Card IPM................................................................... 166
No.3103_0000001949
No.3103_0000001949
This chapter contains general notes and definitions that are important for the
use of this documentation.
1 General notes
The warnings set out here apply to all parts of this documentation.
Dräger reserves the right to make changes to the device and/or to this
documentation without prior notice. This documentation is intended solely as
an information resource for maintenance personnel or technical specialists.
1.3 Definitions
WARNING
An important advisory indicating a potentially hazardous situation
which may result in death or serious injury if not prevented.
CAUTION
An important advisory indicating a potentially hazardous situation which may
result in minor or moderate injury to the user or patient or in damage to the
medical product or other assets if not prevented.
NOTE
A NOTE provides additional information intended to avoid inconvenience
during operation and/or servicing.
Term Definition
Maintenance Maintaining the operative condition of a medical product
by suitable means
Inspection Assessment of the actual condition of a medical product
Servicing Maintaining the operative condition of a medical product
by recurrent, specified measures
Repair Restoring the operative condition of a medical product
after failure of a device function
WARNING
The device must be regularly inspected and serviced by maintenance
personnel. Repairs and complex maintenance work on the medical
product must be carried out by qualified specialists.
If you require a service contract, or for any necessary repair work,
Dräger recommends DrägerService. Dräger recommends using
original Dräger parts for servicing.
If the aforementioned instructions and recommendations are ignored,
the correct functioning of the medical product may be put at risk. Pay
attention to the "Servicing" section of the Instructions for Use.
WARNING
Non-conforming test values
If test values do not conform to specifications, the safety of the patient
may be put at risk.
– Do not put the device into operation if test values do not conform to
specifications.
– Contact your local service organization.
WARNING
Impermissible modifications to the device
If impermissible modifications are made to the device, the safety of the
patient may be put at risk.
Do not modify the device without Dräger's permission.
WARNING
Risk of infection
The unit may transmit pathogens following use on the patient.
– Before carrying out any servicing, ensure that the device and its
components have been handed over by the user cleaned and
disinfected.
– Service only cleaned and disinfected units and unit components.
WARNING
Risk to patient.
Ensure that no patient is connected to the device before starting
maintenance or repair work.
NOTE
Where reference is made to legislation, regulations and standards, in
respect of devices used and serviced in Germany they are based on the
laws of Germany. Users and technicians in other countries must comply with
their national laws and/or international standards.
No.3103_0000001949
No.3103_0000001949
1 System overview
1.1 Introduction
The following text describes the structure, the functional principle, and the
connections of the Fabius plus.
1.2 Design
The Fabius plus comprises the following assemblies:
– Display unit and control panel
– Flowmeter block
– Gas inlet block
– Compact breathing system
– Pneumatic assembly
– Ventilator
– Vapor anaesthetic agent vaporizer
– Trolley
The integrated components monitor the airway pressure, the volume, and the
fraction of inspired oxygen.
No.3103_0000001949
5026
No. Designation
1 Compact breathing system
2 Ventilator
3 Interlock Vapor mount
4 O2 flush
5 Control panel (settings for ventilation parameters and airway
monitoring)
6 Monitor
7 Manometer for pin-index cylinders (O2, N2O)
8 Flowmeter block
9 Valves for fresh-gas metering
10 Trolley
5030
No. Designation
1 COM1 (serial port)
2 APL (tube connector for APL bypass valve)
3 PEEP (tube connector for PEEP valve)
4 Oxygen sensor connection
5 Positive pressure ventilation (airway pressure connector)
6 Volume sensor (Spirolog sensor)
7 Power cord strain relief
No.3103_0000001949
5027
Item Designation
1 Three vertically-arranged inlets for pipeline gas supply (from top to
bottom: N2O, AIR and O2)
2 Three vertically-arranged inlets for the reserve gas cylinders (from
top to bottom: N2O, AIR and O2) (optional)
3 Pin-index connector for N2O or AIR (optional)
4 Pin-index connector for O2 (optional)
No.3103_0000001949
2 Leak test
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.
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 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 PEEP/Pmax valve is used to close off the expiratory part of the
pneumatic circuit. Only the patient circuit is tested.
The test begins by opening the PEEP valve. Also a check is made to locate
the piston.
If the piston is above the desired starting position the piston is servoed
downward.
If the piston is below the desired starting position the piston is servoed
upward.
Then the PEEP valve is closed and so only the ventilator circuit is checked.
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.
3 Ventilation modes
5534
Item Designation
1 Manual breathing bag
2 Fresh gas inlet
3 Fresh gas isolation
4 Ventilator
5 Inspiratory valve
6 Pressure sensor
7 Oxygen sensor
8 Inspiratory tube
9 Y-piece
10 Lung
11 Expiratory tube
12 Flow sensor
13 PEEP/Pmax valve
14 Expiratory valve
15 APL bypass valve
16 APL valve
17 Non-return valve
18 Absorber
Manual ventilation: During inspiration, expiratory valve 14 remains closed. When the operator
Inspiration compresses the breathing bag 1 the gas mixture (expiratory gas and fresh
gas 2) flows through the fresh gas isolation valve 3, the inspiratory valve 5,
the O2 sensor 7, the inspiratory tube 8, and the Y-piece 9 into the patient’s
lung 10. The pressure sensor 6 measures the airway pressure. The
ventilation pressure is limited by the APL valve 16. Any excess amount of the
gas mixture flows through the APL valve and the non-return valve 17 to the
anaesthetic gas scavenging system.
No.3103_0000001949
4207
Manual ventilation: During expiration, the inspiratory valve remains closed thus preventing the
Expiration – Cosy 2.6 expiratory gas from flowing back into the inspiratory branch.
breathing system
The item numbers in the following paragraph refer to Fig. 6.
After releasing the breathing bag 1, the expiratory gas from the lung 10 flows
through the expiratory tube 11, the flow sensor 12, the PEEP/Pmax valve 13,
the expiratory valve 14 and through the absorber 18 into the breathing bag.
At the same time, new fresh gas 2 flows into the manual ventilation bag.
No.3103_0000001949
4209
Spontaneous breathing: During inspiration, the expiratory valve remains closed thus preventing
Inspiration rebreathing of expiratory gas containing CO2.
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.
No.3103_0000001949
4211
Spontaneous breathing: During expiration, the inspiratory valve remains closed thus preventing the
Expiration – Cosy 2.6 expiratory gas from flowing back into the inspiratory branch.
breathing system
The item numbers mentioned in the following paragraphs refer to Fig. 8.
The 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.
No.3103_0000001949
4213
The APL bypass valve opens in volume ventilation mode, allowing excess
gas to be vented to the scavenging system regardless of the MAN/SPONT
valve setting.
The safety valve of the lung ventilator makes sure that no pressures greater
than 75 cmH2O (mbar) build up in the system.
During ventilation, the pressure limit (Pmax) can be adjusted at the user
interface.
Volume/pressure control During inspiration, the PEEP/Pmax valve remains closed. The control
ventilation mode: pressure present at the PEEP/Pmax valve varies with the set pressure limit
Inspiration (Pmax).
The 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 ventilation pressure cannot exceed the pressure limit (Pmax)
set on the control box because the PEEP/Pmax valve 13 opens. The fresh
gas then fills the manual ventilation bag 1.
Any excess fresh gas flows through the open APL bypass valve 15, and the
non-return valve 17 into the anaesthetic gas scavenging system.
4215
Volume/pressure control During expiration, the inspiratory valve remains closed thus preventing
ventilation mode: rebreathing into the inspiratory branch.
Expiration
The item numbers mentioned in the following paragraphs refer to Fig. 10.
The expiratory gas from the lung 10 flows through the expiratory tube 11, the
flow sensor 12, the PEEP/Pmax valve 13, the expiratory valve 14, and the
absorber 18 back into the manual ventilation bag 1 mixing with fresh gas 2
also flowing into the manual ventilation bag.
The ventilator's piston 4 moves back drawing the gas mixture needed for the
next inspiration into the piston space.
Any excess fresh gas flows through the open APL bypass valve 15, and the
No.3103_0000001949
4217
No.3103_0000001949
1 Ventilator .................................................................................................................................. 24
2 Pneumatic assembly ................................................................................................................ 28
3 Function description of the gas box .......................................................................................... 30
4 SORC (Sensitive Oxygen Ratio Controller) .............................................................................. 32
5 Cosy 2.6 breathing system ....................................................................................................... 34
6 Anaesthetic vaporizer ............................................................................................................... 37
7 Semi-open adapter ................................................................................................................... 38
8 Wall-mounted unit..................................................................................................................... 42
No.3103_0000001949
1 Ventilator
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.
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 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.
No.3103_0000001949
4218
Item Designation
1 Ventilator housing
2 Safety valve
3 Auxiliary air valve
4 Ventilator pressure sensor line
5 Vacuum line to the pneumatic assembly
6 Upper seal
7 Piston
8 Lower seal
9 Motor/ballscrew assembly
10 Incremental encoder
11 Light barrier
The top of the ventilator assembly (patient system) contains two valves:
No.3103_0000001949
4219
Item Designation
1 Screw
2 Spring
3 Crater
4 Washer
5 Valve disk
No.3103_0000001949
Item Designation
1 Threaded ring
2 Valve disk
3 Valve cross with spring
4 Connecting screw
No.3103_0000001949
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.
The fixed metering smoothes out pressure fluctuations. The filter provides
noise damping.
No.3103_0000001949
The variable restrictor is used to set the negative pressure level in a range of
–150 mbar (cmH2O) to –240 mbar (cmH2O).
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.
No.3103_0000001949
The supply gases flow through the filters and non-return valves in the gas
inlet assembly. Pipeline supply pressures are indicated on pipeline
manometers located on the flowmeter assembly. High-pressure cylinder
manometers are located on the trolley assembly. The cylinder pressure
regulators for PIN index are built-in to the gas box. The pressures of O2 and
N2O delivered to the flowmeter assembly are set by regulators on the gas
inlet assembly.
If the O2 supply fails or its pressure decreases below a certain limit, the O2
low alarm switch generates an alarm.
4133
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.
No.3103_0000001949
9586
The SORC is a control element. The SORC makes sure the fresh gas always
contains a vital O2 concentration.
In the event of an O2 shortage, the SORC limits the N2O flow such that the
O2 concentration in the fresh gas does not decrease below 23 vol.%.
If the O2 flow control valve is closed or if the O2 flow is lower than or equal to
200 mL/min, the SORC interrupts the N2O flow.
N2O can be added as of an O2 flow of approx. 300 mL/min. In this case, the
SORC also prevents O2 concentrations below 23 vol.%.
The SORC bypass valve allows oxygen to bypass the restrictor in the SORC
when O2 flows above 10 L/min are needed.
9587
The O2 and N2O flows are adjusted with the flow control valves.
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.
No.3103_0000001949
4221
Item Designation
1 Control diaphragms
2 Resistors
3 N2O non-return valve
4 Operating-point adjusting screw
5 Flow control valves
No.3103_0000001949
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
In the "SPONT" switch position the APL valve is open to atmosphere. This
position is used for spontaneous breathing.
Using the control box and the PEEP/Pmax valve, the pressure limit (Pmax)
can also be adjusted during volume controlled ventilation between 15 and
70 mbar via the keypad.
The absorber canister is filled with fresh soda lime. The CO2 is scrubbed from
the expiratory gas by the soda lime.
No.3103_0000001949
4136
Item Designation
1 Inspiratory connection
2 Pressure sensor connection (not visible)
3 Inspiratory valve and O2 sensor connection
4 Fresh gas isolation valve
5 APL bypass valve
6 PEEP/Pmax valve
7 MAN/SPONT APL valve
8 Anaesthesia monitor return line (only for systems outside the
USA)
9 Fresh gas port
10 Ventilator connection
11 Anaesthetic gas scavenging port
12 Absorber
No.3103_0000001949
Item Designation
16 Expiratory connection
17 Expiratory valve
4130
6 Anaesthetic vaporizer
7 Semi-open adapter
The semi-open adapter is used in conjunction with the Cosy 2.6 patient
system.
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.
The pressure sensor 6 measures the airway pressure. The pressure exerted
on the manual breathing bag 1 closes the exhaust gas scavenging line in the
semi-open adapter 12. The ventilation pressure is limited by the APL valve
10. Any excess amount of the gas mixture flows through the APL valve 10
into the anaesthetic gas scavenging system 11.
No.3103_0000001949
4801
During expiration, the inspiratory valve 3 remains closed thus preventing the
expiratory gas from flowing back into the inspiratory branch.
After releasing the breathing bag 1, the expiratory gas from the lung 4 flows
through the flow sensor 5, the PEEP/Pmax valve 6, the expiratory valve 7
and anaesthetic gas scavenging line of the semi-open adapter 11. At the
4824 same time, new fresh gas 2 flows into the manual breathing bag 1.
The patient inhales the gas mixture and fresh gas 2 from the manual
breathing bag 1. The gas mixture flows through the fresh gas decoupling
valve 3, the inspiratory valve 5 and the O2 sensor 7 into the lung 8. The
pressure sensor 6 measures the airway pressure.
Any excess amount of the gas mixture flows into the anaesthetic gas
scavenging system 12 and13.
4803
During expiration, the inspiratory valve 4 remains closed thus preventing the
expiratory gas from flowing back into the inspiratory branch.
The APL valve 10 is open. The expiratory gas flows from the lung 5 through
No.3103_0000001949
the flow sensor 6, the PEEP control valve 7, the expiratory valve 8 and the
semi-open adapter 12. At the same time, new fresh gas 2 flows into the
manual breathing bag 1.
When the manual breathing bag is full, any excess gas mixture flows through
the semi-open adapter 12 into the anaesthetic gas scavenging system 11.
4804
8 Wall-mounted unit
The wall version of the Fabius does not include the trolley.
8.1 Introduction
The illustrations accompanying this description are generic depictions.
1 To enable the unit to be rotated, turn the locking lever on the rear of the
unit 180° clockwise.
2 Rotate the unit left or right as desired, but not by more than 90°.
3 Make sure no cable or tubing is squeezed in the process.
Fabius can be used when set to the desired position.
4 On completing work, rotate Fabius back to its home position.
No.3103_0000001949
5480
No.3103_0000001949
1 Control PCB.............................................................................................................................. 46
2 Electrical block diagram............................................................................................................ 47
3 Control unit ............................................................................................................................... 48
4 Battery backup.......................................................................................................................... 50
5 FiO2 measurement ................................................................................................................... 51
6 Respiratory Flow Measurement................................................................................................ 53
No.3103_0000001949
1 Control PCB
8038
3 Control unit
Data and power for the display comes from the Control PCB via a 20-
conductor ribbon cable. The keypad interface is connected to the Control
PCB by a 30-conductor ribbon cable. A block diagram of the control panel
assembly is shown in the following illustration.
5527
Item Function
1 Selects volume controlled ventilation mode
Item Function
5 Switches the ventilator to MAN/SPONT mode
4 Battery backup
The batteries are located inside the control box. The 3.15 A battery fuse is
located at the rear of the control box.
4131
No.3103_0000001949
5 FiO2 measurement
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.
Fig. 32 O2 sensor
Item Designation
1 Teflon membrane
2 Gold cathode A
3 Lead anode
4 Temperature compensation resistors
5 Alkaline electrolyte
6 Gold cathode B
The 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.
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.
No.3103_0000001949
The different gases present in the respiratory gas have a different thermal
conductivity. The amount of heat removed from the second platinum wire is
thus an indicator of respiratory gas composition.
Internal calibration tables for O2/N2O mixtures, Air and 100% O2 are used to
linearize the measured flow.
4229
Item Designation
"A" Platinum wire "A"
"B" Platinum wire "B"
No.3103_0000001949
No.3103_0000001949
Parts catalog
Test Instructions
1 Parts catalog............................................................................................................................. 56
2 Test Instructions / Service Card IPM ........................................................................................ 115
3 Result Sheet Test instructions / Service Card IPM................................................................... 166
No.3103_0000001949
1 Parts catalog
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2125
Warning
Revision 3.0
All servicing and/or test procedures on the 9500840
device require detailed knowledge of this docu-
mentation. Use of the device requires detailed
knowledge and observance of the relevant
Instructions for Use.
No.3103_0000001949
)DELXVSOXV
Table of contents
Table of contents
Important notes 5
1 Device configuration 5
1.1 Basic device configuration ....................................................................................................... 5
1.1.1 Serial number / software (if not otherwise recorded) ................................................. 5
2 Maintenance parts 6
2.1 Maintenance intervals, overview.............................................................................................. 6
2.2 Maintenance parts by specified interval................................................................................... 7
2.2.1 Lithium battery (every 3 years) .................................................................................. 7
2.2.2 Lead-gel battery (3-yearly)......................................................................................... 7
2.2.3 Input pressure regulator test (every 3 years)............................................................. 8
2.2.3.1 Downstream pressure of pipeline supply O2 input pressure regulator.................. 8
2.2.3.2 Downstream pressure of pipeline supply N2O input pressure regulator (not appli- 9
cable in nitrous-oxide-free mode) ..............................................................................
2.2.4 Drägersorb CLIC option............................................................................................. 9
2.2.4.1 Drägersorb Clic option (old, yearly) ....................................................................... 9
2.2.4.2 Drägersorb Clic option (new, yearly) ..................................................................... 10
2.2.4.3 Drägersorb Clic option (old, every 2 years) ........................................................... 10
2.2.4.4 Drägersorb Clic option (new, every 2 years) ......................................................... 10
2.2.4.5 Drägersorb Clic option (every 4 years).................................................................. 10
2.2.5 Pin index option (every 6 years) ................................................................................ 10
3 Electrical safety 12
3.1 Electrical safety, base unit, to DIN EN 62353 (IEC 62353) ...................................................... 12
3.1.1 Visual check............................................................................................................... 12
3.1.2 Protective earth resistance ........................................................................................ 13
3.1.3 Protective earth resistance measuring points............................................................ 14
3.1.4 Equipment leakage current........................................................................................ 14
3.2 Option: Electrical safety, COSY2 heater power supply unit, to DIN EN 62353 (IEC 62353).... 16
3.2.1 Visual check............................................................................................................... 16
3.2.2 Protective earth resistance ........................................................................................ 16
3.2.3 Protective earth resistance measuring points............................................................ 17
3.2.4 Equipment leakage current........................................................................................ 17
3.3 Electrical safety according to IEC 60601-1 .............................................................................. 19
3.3.1 Base unit.................................................................................................................... 19
3.3.2 Protective earth resistance ........................................................................................ 19
3.3.3 Earth leakage current ................................................................................................ 20
3.3.4 Optional COSY2 heater power supply unit, protective earth conductor resistance ... 21
3.3.5 Optional COSY2 heater power supply unit, earth leakage current ............................ 21
4 Function and condition test 22
4.1 Base unit .................................................................................................................................. 22
4.1.1 Labels and instructions for use .................................................................................. 22
4.1.2 Condition and function of the base unit ..................................................................... 23
No.2301_0000007441
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Table of contents
5 Test equipment 42
5.1 Test equipment ........................................................................................................................ 42
5.1.1 Test equipment subject to mandatory calibration ...................................................... 42
No.3103_0000001949
)DELXVSOXV
Table of contents
No.2301_0000007441
No.3103_0000001949
)DELXVSOXV
Device configuration
Important notes
NOTE
Prior to using these test instructions, check that they are the latest revision
(compare revision with latest service documentation).
All results and inputs can be documented in the "Test Report" or "Result
Sheet".
NOTE
Do not use these test instructions for testing after a repair.
NOTE
If the "nitrous-oxide-free anaesthesia" upgrade kit is available, no nitrous
oxide-related tests are required.
For the devices listed below, the test instructions specific to the relevant
device must be used:
– Vapor 19.n
– Vapor 2000
– Vapor 3000
– Devapor
– Connected monitoring
– Silverline pressure regulator
Conversions: 1 bar = 14.504 psi; 1 mbar = 1.01973 cmH2O.
1 Device configuration
NOTE
The serial number is located on the rear of the device.
No.3103_0000001949
)DELXVSOXV
Maintenance parts
NOTE
The serial number is located on the side of the breathing system.
2 Maintenance parts
NOTE
Drägersorb option: New devices use the Drägersorb Clic adapter (MX50090)
instead of older adapters for which the seal set has to be changed separately
at short intervals.
The Drägersorb Clic adapter (MX50090) is only replaced every four years,
and then completely.
NOTE
Pin index option: The upgrade kit for the pressure regulator is replaced
depending on the connection variant.
)DELXVSOXV
Maintenance parts
NOTE
Batteries are special waste. Dispose of batteries in accordance with local
waste disposal regulations.
NOTE
No.2301_0000007441
)DELXVSOXV
Maintenance parts
Test set-up
2475
Item Designation
1 N2O outlet (to the N2O flow-control valve)
2 Gas inlet assembly
3 N2O input pressure regulator
4 O2 input pressure regulator
5 O2 outlet (to the O2 flow-control valve)
6 T-connector (7901458)
7 To O2 flow control valve
8 To N2O flow control valve
9 Digital manometer (7910724)
Action • Relieve all cylinder and pipeline supply pressures.
• Disconnect all cylinders and pipeline supply tubes.
• Prepare the test setup for the O2 input pressure regulator (see Fig. 1).
• Connect the O2 pipeline supply to the gas inlet assembly.
No.2301_0000007441
)DELXVSOXV
Maintenance parts
2.2.3.2 Downstream pressure of pipeline supply N2O input pressure regulator (not appli-
cable in nitrous-oxide-free mode)
Action • Remove the N2O pressure tube from the N2O outlet of the gas inlet block
and interconnect the digital manometer. Refer to the previous illustration.
• Reconnect the O2 and N2O pipeline tube to the pipeline supply inlet ports
and activate the pipeline supplies.
• Set the O2 and N2O flows at the flow control valves to 2.5 L/min.
Test The N2O pressure regulator output pressure is 2.2 to 2.6 bar.
Result N2O pipeline supply input pressure regulator downstream pressure (not
applicable in nitrous-oxide-free mode)
[________OK]
XXXX
)DELXVSOXV
Maintenance parts
)DELXVSOXV
Maintenance parts
Replace the N2O pressure regulator with the long non-return valve:
Replacing the N2O pressure regulator with the short non-return valve:
Replace the O2 pressure regulator with the short non-return valve and the T
connection.
Replace the O2/Air pressure regulator with the long non-return valve and L
connection:
Replace the O2/Air pressure regulator with the short non-return valve and L
connection:
No.2301_0000007441
No.3103_0000001949
)DELXVSOXV
Electrical safety
3 Electrical safety
NOTE
The device conforms to the conditions of protection class I, type BF.
Notes
The following subsections provide descriptions of device checks, recurrent
testing and testing after servicing of medical electrical (ME) devices.
NOTE
The tester, e.g. SECUTEST, must be correctly configured for all measure-
ments. If implausible measurement results are obtained, such as a leakage
current of 0.0 A, check the tester configuration in addition to the test setup!
NOTE
In testing to IEC 62353, the medical electrical device (ME device) or the med-
ical electrical system (ME system) must be tested.
ME systems must be treated like ME devices.
An ME system is a combination of several devices, as specified by the manu-
facturer, of which at least one must be an ME device, which are intercon-
nected by a functional connection or by means of a multiple socket outlet.
NOTE
In the case of devices connected to other devices by a data cable, this con-
nection must be disconnected prior to performing the electrical safety test, in
order to avoid false measurements.
No.2301_0000007441
)DELXVSOXV
Electrical safety
Action
WARNING
Hazardous voltage
Touching live components can lead to serious injury or death.
Ź Before checking the power fuse links, disconnect the mains plug from the
socket-outlet.
Item Designation
1 Tester
2 Device under test
3 Tester probe cable
L Conductor
N Neutral conductor
PE Protective earth conductor
Action • Prepare the test setup.
• Switch the tester on.
• Configure the tester appropriately and follow the instructions on the tester.
• Using the tip of the probe cable, scan each of the points on the device
under test listed under Protective earth resistance measuring points one
after the other, moving the mains power cable along the entire length
during the measurement. The resistance must not change when you do so.
Test The protective conductor resistance of devices with detachable but con-
nected mains power cables must not exceed 0.3 Ohm in each case.
No.2301_0000007441
)DELXVSOXV
Electrical safety
Test If other optional power cables are fitted, the respective protective conductor
resistance must not exceed 0.1 Ohms. Move the power cable along the entire
length during the measurement. The resistance must not change when you
do so.
Result Maximum measured value of optional power cable.
[________ȍ]
or
Test The protective conductor resistance of ME systems (including mains power
cable) must not exceed 0.5 Ohm in each case.
Result Maximum measured value of ME system.
[________ȍ]
NOTE
The device leakage current can be tested by the differential measurement
method or the direct measurement method.
In direct measurement, set up the device under test with insulation and scan
all touchable conductive components using the probe (the protective conduc-
tor is internally interrupted in the tester).
)DELXVSOXV
Electrical safety
Test set-up
1932
Fig. 3 Device leakage current
Item Designation
1 Tester
2 Device under test
3 (applied part) Device-specific test adapter for tester
4 (applied part) Configurable sockets for applied parts
L Conductor
N Neutral conductor
PE Protective earth conductor
Action • Prepare the test setup.
• (applied part) Connect the device-specific test adapter on one end to the
device under test and on the other end to the tester's configurable socket
"A" for applied parts (paying attention to the configuration!).
• Follow the instructions on the tester.
NOTE
The test must be performed twice! The second test is performed with the plug
rotated 180° in the socket. In many test devices the mains plug rotation is
simulated by means of a built-in selector switch. The higher measured value
must be documented.
NOTE
The reference value (initial measured value) must always be transmitted!
NOTE
If the measured values are between 90% and 100% of the permissible limit
value, the reference value and the previously measured values of the recur-
rent test should be applied to assess electrical safety!
Test The recurrent measurement value must not exceed 500 A.
No.2301_0000007441
)DELXVSOXV
Electrical safety
3.2 Option: Electrical safety, COSY2 heater power supply unit, to DIN EN
62353 (IEC 62353)
NOTE
The device conforms to the conditions of protection class I, type B.
Item Designation
1 Tester
2 Device under test
3 Tester probe cable
L Conductor
No.2301_0000007441
N Neutral conductor
PE Protective earth conductor
No.3103_0000001949
)DELXVSOXV
Electrical safety
or
Test The protective conductor resistance of ME systems (including mains power
cable) must not exceed 0.5 Ohm in each case.
Result Maximum measured value of ME system.
[________ȍ]
NOTE
The device leakage current can be tested by the differential measurement
method or the direct measurement method.
In direct measurement, set up the device under test with insulation and scan
all touchable conductive components using the probe (the protective conduc-
tor is internally interrupted in the tester).
No.3103_0000001949
)DELXVSOXV
Electrical safety
Test set-up
1932
Fig. 5 Device leakage current
Item Designation
1 Tester
2 Device under test
3 (applied part) Device-specific test adapter for tester
4 (applied part) Configurable sockets for applied parts
L Conductor
N Neutral conductor
PE Protective earth conductor
Action • Prepare the test setup.
• (applied part) Connect the device-specific test adapter on one end to the
device under test and on the other end to the tester's configurable socket
"A" for applied parts (paying attention to the configuration!).
• Follow the instructions on the tester.
NOTE
The test must be performed twice! The second test is performed with the plug
rotated 180° in the socket. In many test devices the mains plug rotation is
simulated by means of a built-in selector switch. The higher measured value
must be documented.
NOTE
The reference value (initial measured value) must always be transmitted!
NOTE
If the measured values are between 90% and 100% of the permissible limit
value, the reference value and the previously measured values of the recur-
rent test should be applied to assess electrical safety!
Test The recurrent measurement value must not exceed 500 A.
No.2301_0000007441
)DELXVSOXV
Electrical safety
NOTE
The following tests are based on testing with the SECUTEST tester. This tes-
ter allows simulation of the power plug rotation. With other testers, it may be
necessary to rotate it manually (the higher measured value shall be docu-
mented).
In the case of devices connected to other devices by a data cable, this con-
nection must be disconnected prior to performing the electrical safety test, in
order to avoid false measurements.
Item Designation
1 Tester, e.g. SECUTEST, 7910594
2 Fabius under test
No.3103_0000001949
)DELXVSOXV
Electrical safety
L Conductor
N Neutral conductor
PE (Protective earth) conductor
Action • Prepare the test setup.
• Switch on the SECUTEST and the Fabius.
• Using the tip of the test probe, scan each of the following points on the
Fabius one after the other:
– Screws on O2 inlet block
– Pin index connection (if fitted)
– Potential equalization pin on power supply unit
– Potential equalization pins on auxiliary sockets
– Protective earth contacts on auxiliary sockets
– Potential equalization pin in ventilator interior
– Screws on control box rear panel
– Vapor plug-in system
– Screws on control box rail
Test The protective earth resistance must not exceed 0.2 Ohm (including mains
power cable) in each case.
Result Protective earth resistance
[________ȍ]
Item Designation
1 Tester, e.g. SECUTEST, 7910594
2 Fabius under test
No.2301_0000007441
L Conductor
N Neutral conductor
PE (Protective earth) conductor
No.3103_0000001949
)DELXVSOXV
Electrical safety
Test In normal condition (N.C.), the value must not exceed 500 A.
Result Normal condition (N.C.)
[________A]
Test In single fault condition (S.F.C.), the value must not exceed 1000 A.
Result Single fault condition (S.F.C.)
[________A]
3.3.4 Optional COSY2 heater power supply unit, protective earth conductor resistance
Test set-up
1629
Fig. 8 Test setup for the protective earth conductor
Item Designation
1 Tester, e.g. SECUTEST, 7910594
2 Heater power supply unit under test
3 Test probe with tip (e.g. SECUTEST accessories)
L Conductor
N Neutral conductor
PE (Protective earth) conductor
Action • Prepare the test setup.
• Switch on the SECUTEST and the heater.
• Using the tip of the test probe, scan the screw heads on the power supply
unit housing.
Test The protective earth resistance must not exceed 0.2 Ohm (including mains
power cable) in each case.
Result Protective earth resistance
[________ȍ]
3.3.5 Optional COSY2 heater power supply unit, earth leakage current
Test set-up
NOTE
No.2301_0000007441
)DELXVSOXV
Function and condition test
1631
Fig. 9 Earth leakage current test setup
Item Designation
1 Tester, e.g. SECUTEST, 7910594
2 Heater power supply unit under test
L Conductor
N Neutral conductor
PE (Protective earth) conductor
Action • Prepare the test setup.
Test In normal condition (N.C.), the value must not exceed 500 A.
Result Normal condition (N.C.)
[________A]
Test In single fault condition (S.F.C.), the value must not exceed 1000 A.
Result Single fault condition (S.F.C.)
[________A]
Action • Switch off the SECUTEST and the heater power supply unit.
This section contains tests to establish whether the device and the accesso-
ries used conform to the stipulations of the Instructions for Use in terms of
condition and function.
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Function and condition test
4.2.2 O2 sensor calibration (not applicable in case of monitoring with external O2 mea-
surement)
Action • After the self-test, the Fabius is in the "Standby" screen.
• Press the "O2 sensor calibr." key and follow the on-screen instructions.
No.2301_0000007441
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Function and condition test
Test After calibration is completed, verify the "O2 sensor error" message has dis-
appeared and calibration was successful.
Result O2 sensor calibr.
[________OK]
2551
Item Designation
1 O2 sensor
2 Adapter top M27961
3 Test adapter 7900138
4 Tube
5 Kuhn connector M28189
6 Fresh gas tube
[________%]
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Function and condition test
4.2.5 Fresh gas leakage test passive (with and without vaporizer)
NOTE
Carry out this test once with the vaporizer fitted and once without vaporizer.
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Function and condition test
Test set-up
1407
Fig. 11 Fresh gas leakage, shown on Fabius GS by way of example
Item Designation
1 Digital manometer 7910722
2 Fresh gas tube
3 Kuhn connector M28189
Action • Connect the unit to the pipeline supply.
• Close any cylinders on the Fabius.
• Unscrew the fresh gas tube from the COSY2 breathing system or (if A-
cone option installed) from the A-cone.
• Close all flow control valves.
• Connect a Kuhn connector and a digital manometer to the fresh gas outlet.
Test No pressure is displayed on the digital manometer.
Result Leak test of flow control valves
[________OK]
NOTE
Carry out this test without the Vapor connected.
No.2301_0000007441
No.3103_0000001949
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Function and condition test
Test set-up
1407
Fig. 12 Fresh gas leakage, shown on Fabius GS by way of example
Item Designation
1 Digital manometer 7910722
2 Fresh gas tube
3 Kuhn connector M28189
Action • The N2O flow control valve is fully open.
• Remove the digital manometer.
• Set a flow rate of 0.10 L/min on the O2 flow valve.
• Connect the digital manometer to the fresh gas tube.
Test If the leakage is less than 0.1 L/min, a pressure greater than 35 mbar can be
built up on the digital manometer.
Result Fresh gas leakage
[________OK]
Result Set the next due service date, and enter it in the test report.
[________dat]
No.2301_0000007441
Action • Use the rotary knob to navigate to the "Main Service Screen".
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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.
NOTE
Before performing the pump calibration/test, a valid pressure calibration must
be performed.
[________OK]
Action • Press the rotary knob to access the "Main Service Screen".
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Function and condition test
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.
Attach breathing hose from expiratory Connect the expiratory valve and the
valve to inspiratory valve and remove inspiratory valve with the breathing
breathing bag. system tube, and remove the breath-
ing bag.
Touch "Calibrate" key. Press the "Calibrate" key.
At completion of calibration "Calibra- On completion of the calibration, the
tion" shall indicate Pass/Fail. readout must be "Calibrate""Pass" or
"Fail".
Test Verify "PEEP Calibration" indicates "pass".
Result PEEP valve calibration complete.
[________OK]
Remove O2 cell from housing. Remove the O2 cell from the housing.
Let current cell values stabilize. Wait for the values to stabilize.
Touch "Store Zero" key to enter the Press the "Store Zero" key to store
current values as the calibration zero. the current values as calibration zero.
Reinstall O2 cell in sensor housing Reinstall the O2 cell into the sensor
housing.
Test O2 zero calibration is complete, when values are displayed under "Stored
zero cell A/B" and no "INVALID" is displayed.
Result O2 zero calibration complete.
[________OK]
Action • Reassemble the O2 sensor housing, and then install the O2 sensor hous-
ing onto the inspiratory dome of the breathing system.
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Function and condition test
NOTE
Unless already selected, set "O2 whistle" to "Enable" under "Configure" in
service mode.
Action • Connect the O2 pipeline supply tube to the gas distributor 7901495.
• Set the O2 flow to 0.5 L/min.
• Open and close the O2 cylinder valve.
Test At an indicated pressure of 1.1 to 1.65 bar the alarm message "LOW O2
SUPPLY PRESSURE!!!" appears, an acoustic alarm sounds and the red
alarm LED comes on.
Result At which pressure does the message appear?
[________bar]
Action • Bleed the remaining O2 pressure from the system, and close the flow con-
trol valve.
• Remove the gas manifold from the device and reconnect the pipeline sup-
ply tubes.
NOTE
Reset "O2 whistle" to customer settings.
sounds.
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Function and condition test
4.4.4 O2 sensor failure alarm (not applicable in case of monitoring with external O2 mea-
surement)
Action • Disconnect the O2 sensor cable from the rear of the Fabius.
Test The "O2 SENSOR ERROR !" message appears and an audible alarm
sounds.
Make sure that the O2 sensor has stabilized in ambient air for several min-
utes.
Action • Re-attach the O2 sensor cable.
• Calibrate O2 sensor.
Result The "O2 SENSOR ERROR !" message has disappeared.
[________OK]
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Function and condition test
Cylinder supply
Action • Open the O2 and N2O cylinder valves (if fitted).
• Set the O2 and N2O flow control valves to 4 L/min.
• Close the O2 cylinder valve (if fitted).
Test The N2O flow ceases when the O2 flow is stopped.
Pipeline supply
Action • Connect the O2 pipeline supply.
• Connect the N2O pipeline supply.
• Set the APL valve to "Spont".
• Set the O2 and N2O flow control valves to 4 L/min.
• Disconnect the O2 pipeline supply.
Test The N2O flow ceases when the O2 flow is stopped.
Action • Close the N2O flow control valve.
Result N2O shut-off (not applicable in nitrous oxide-free mode)
[________OK]
4.6.2 O2 concentration and gas type test (not applicable in nitrous oxide-free mode)
Prerequisites Fabius is in “Man/Spont” ventilation mode.
Test set-up
2551
Item Designation
No.2301_0000007441
1 O2 sensor
2 Adapter top M27961
3 Test adapter 7900138
No.3103_0000001949
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Function and condition test
Item Designation
4 Tube
5 Kuhn connector M28189
6 Fresh gas tube
Action • Prepare the O2 sensor calibration test setup.
• Connect the Air pipeline supply.
• Set the Air flow control valve to 4 L/min.
Test Air pipeline supply manometer indicates pipeline pressure.
Action • Open the O2 and N2O flow control valves.
Test The O2 and N2O manometers indicate no pressure.
Result Air pipeline supply manometer indicates pipeline pressure
[________OK]
Test The O2 and N2O flow on the flowmeter block is equal to 0 L/min.
Result No O2 or N2O flow
[________OK]
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Function and condition test
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Function and condition test
1438
Fig. 14 Test setup for the pressure-limiting valve
Item Designation
1 Test connector M13506
2 Digital manometer 7910722
Action • Set the following values:
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Function and condition test
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Function and condition test
pmax = 70 mbar
Vt = 380 mL
Freq = 12 BPM
TI:TE = 1:1
TIP:TI = 10%
PEEP = 0 mbar
No.3103_0000001949
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Function and condition test
Action • Bleed all pressure from the cylinder circuits using the flow control valves.
Test The cylinder manometers indicate 0 bar/psi.
Result Function of non-return valve and manometer
[________OK]
Action • Connect the cylinders and open the valves one after the other.
4.10.2 Checking the pressure regulator option of the pin index cylinders
Test set-up
1411
Item Designation
1 Test cylinder
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Function and condition test
Item Designation
3 Test adapter 7901495
4 Device inlet
5 O2 pipeline supply
O2 pressure regulator
Action • Prepare the pressure regulator test setup and connect the test adapter (3)
to the O2 pipeline supply connector at the device inlet (4).
• Set the pressure at the test pressure regulator (2) to 5 bar.
• Open the O2 pin index cylinder valve.
• Set the O2 flow valve to 4 L/min.
• Close the valve of the test cylinder (1).
Test After the pressure drop has stabilized, read the output pressure indicated on
the manometer (2) upstream of the test adapter (3). (This value is equal to
the output pressure of the O2 pin index cylinder regulator).
NOTE
If the pressure does not drop, either the hospital supply pressure is too low or
the regulator pressure is set too high.
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Function and condition test
Action • Prepare the pressure regulator test setup and connect the test adapter (3)
to the Air pipeline supply connector at the device inlet (4).
• Open the Air pin index cylinder valve.
• Set the Air flow on the Air flow control valve of the Fabius to 4 L/min.
• Close the valve of the test cylinder (1).
Test After the pressure drop has stabilized, read the output pressure indicated on
the manometer (2) upstream of the test adapter (3). (This value is equal to
the output pressure of the Air pin index cylinder regulator).
Result Air pressure regulator
[________OK]
1496
Item Designation
1 Flowmeter (7901161)
2 Connecting sleeve (M13506)
3 Reducing sleeve (7900034) / N2O adapter / Air adapter
Action • Connect the relevant O2/N2O high-pressure cylinder to the gas inlet block.
• Connect the test setup in sequence to the O2 and N2O pipeline supply con-
nectors on the gas inlet block.
No.2301_0000007441
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Function and condition test
Test The flow rate indicated on the flowmeter (1) is less than/equal to 5 mL/min.
Result O2 pipeline supply connection max. 5 mL/min.
[________mL/min]
Action • Remove the O2/N2O high-pressure cylinders from the gas inlet block.
• Connect the pipeline supply to the O2 and N2O connectors of the gas inlet
block.
• Connect the test setup in sequence to the O2 and N2O high-pressure cylin-
der connectors on the gas inlet block.
Test The flow rate indicated on the flowmeter (1) is less than/equal to 5 mL/min.
Result O2 high-pressure cylinder connector max. 5 mL/min.
[________mL/min]
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Test equipment
5 Test equipment
This section sets out the test equipment required for the tests in this test pro-
cedure.
NOTE
Tests must be carried out with tests equipment that is calibrated in the appro-
priate way.
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Test equipment
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Test equipment
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Test equipment
No.3103_0000001949
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Annex
Wrench, 3/8 in
Breathing bag, 3-litre
Tube, corrugated, 22 mm x 12 in. long.
6 Annex
No.2301_0000007441
This section contains further information which may be helpful in testing the
device.
No.3103_0000001949
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Annex
Press and hold down the "Standby" and "Home" keys and at the same time
press the rotary knob to access service mode.
XL
O2 Monitoring Enable/Disable
(O2 monitoring) (enable/disable)
No.3103_0000001949
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Annex
Pressure ---------
(Pressure)
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Annex
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Annex
No.2301_0000007441
No.3103_0000001949
No.3103_0000001949
Key
9 / OK = OK
Applies to Test Instructions / Service Card IPM Revision 3.0 + = Spare part used
! = Error / Report
/ = Accessory not available
- = Not applicable
4.10.1.2 Leakage OK
Report:
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No.3103_0000001949
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As of 2015-08:
Dräger Medical GmbH
changes to
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Revision 3.0
9036798
5330.450
No.3103_0000001949