Technical Manual
Technical Manual
Fabius plus
Inhalation Anesthesia Machine
Warning
No.0312_0000001949_Publication
Table of contents
General 5
1 General notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.1 Notes on use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.2 Copyright and other protected rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.4 General safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Function descriptions 9
1 System overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.2 Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.3 Functional principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.4 Connections, interfaces, and components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2 Leak test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.1 System leakage (compliance calculation) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.2 Ventilator leakage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.3 Valve test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3 Ventilation modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.1 Function Description: Manual ventilation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.2 Function Description: Spontaneous breathing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.3 Function Description: volume/pressure control ventilation mode . . . . . . . . . . . . . . . . . . 20
Function descriptions pneumatic assembly 23
1 Ventilator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
1.1 Safety valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
1.2 Auxiliary air valve. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
2 Pneumatic assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
2.1 PEEP/Pmax valve control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
2.2 APL bypass valve control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
3 Function description of the gas box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4 SORC (Sensitive Oxygen Ratio Controller) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
5 Cosy 2.6 breathing system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
6 Anaesthetic vaporizer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
7 Semi-open adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
7.1 Manual ventilation: General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
7.2 Manual ventilation: Inspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
7.3 Manual ventilation: Expiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
7.4 Spontaneous breathing: General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
7.5 Spontaneous breathing: Inspiration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
7.6 Spontaneous breathing: Expiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
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8 Wall-mounted unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
8.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
8.2 Rotation function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Function descriptions electronics 43
1 Control PCB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
2 Electrical block diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
3 Control unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
4 Battery backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
5 FiO2 measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
6 Respiratory Flow Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Annex 51
No.0312_0000001949_Publication
This chapter contains general notes and definitions that are important for the
use of this documentation.
General 5
1 General notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.1 Notes on use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.2 Copyright and other protected rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.4 General safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
No.0312_0000001949_Publication
1 General notes
1.1 Notes on use Read through the following notes thoroughly before applying this documenta-
tion.
Dräger reserves the right to make changes to the device and/or to this docu-
mentation without prior notice. This documentation is intended solely as an
information resource for experts.
1.2 Copyright and other The content of this documentation, in particular its design, text, software,
protected rights technical drawings, configurations, graphics, images, data and their selection
and its composition and any amendments to it ("content") are protected by
copyright. The content must not (in whole or in part) be modified, copied, dis-
tributed, reproduced, republished, displayed, transmitted or sold without the
prior written consent of Dräger.
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, may result in minor or moderate
injury to the user or patient or in damage to the medical device or other
property.
NOTE
A NOTE provides additional information intended to avoid inconvenience
during operation and/or servicing.
1.4 General safety pre- Read through each section thoroughly before beginning servicing. Always
cautions use the correct tools and the specified test equipment. Otherwise the device
may not work correctly or may be damaged.
WARNING!
Improper servicing
If the medical product is not properly serviced, the safety of the patient
No.0312_0000001949_Publication
NOTE
Dräger recommends entering into a service contract with DrägerService
and having all repairs likewise carried out by DrägerService.
WARNING!
Replacement parts not certified by Dräger standards
Dräger cannot guarantee or confirm the operational safety of third-party
replacement parts used on the device.
– Use only replacement parts certified to Dräger standards for servicing
of the device, otherwise the proper functioning of the device may be
compromised.
– 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 device may transmit pathogens following use on the patient.
– Before carrying out any servicing, ensure that the device and its com-
ponents have been handed over by the user cleaned and disinfected.
– Service only cleaned and disinfected devices and device components.
WARNING!
Risk to patients
– Ensure that no patient is connected to the device before starting main-
tenance 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
1.0No.0312_0000001949_Publication
No.0312_0000001949_Publication
Function descriptions 9
1 System overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.2 Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.3 Functional principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.4 Connections, interfaces, and components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2 Leak test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.1 System leakage (compliance calculation) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.2 Ventilator leakage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.3 Valve test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3 Ventilation modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.1 Function Description: Manual ventilation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.2 Function Description: Spontaneous breathing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.3 Function Description: volume/pressure control ventilation mode . . . . . . . . . . . . . . . . . . 20
No.0312_0000001949_Publication
1 System overview
1.1 Introduction The following text describes the structure, the functional principle, and the
connections of the Fabius plus.
1.3 Functional principle The Fabius plus is an inspiratory anaesthetic unit with continuous flow.
The integrated components monitor the airway pressure, the volume, and the
fraction of inspired oxygen.
No. Designation
No.0312_0000001949_Publication
No. Designation
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
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
8 Power cord connection (with fuses)
9 ON/OFF switch
10 Battery fuse
1.0No.0312_0000001949_Publication
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.0312_0000001949_Publication
2 Leak test The „Leck-/Compl-Test” menu screen provides instructions on how to start
the leakage 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.
2.1 System leakage The „Leck-/Compl-Test” menu prompts the user to do the following:
(compliance calcula- – Close the fresh gas valves.
tion) – Connect the Y-piece.
– Set the Man/Spont valve to „Man“.
– Set the pressure to 40 mbar to 50 mbar.
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 pres-
sure yields the system compliance value. This compliance value is used
when calculating the system leak rate only. The system compliance is calcu-
lated in the next step upon completion of the system leakage test.
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.
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 pneu-
matic 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 down-
ward.
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 calcula-
tion 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 appropri-
ate error message if one of the error conditions is met.
The result of the „ventilator leakage test“ is displayed after each test.
2.3 Valve test After completion of the leakage test and compliance test, the auxiliary air
valve, the pressure limiting valve, and the PEEP/Pmax valve are tested.
No.0312_0000001949_Publication
3 Ventilation modes
Item Designation
1 Manual breathing bag
2 Fresh gas inlet
3 Fresh gas isolation
4 Ventilator
5 Inspiratory valve
6 Pressure sensor
7 Oxygen sensor
8 Inspiratory tube
9 Y-piece
10 Lung
11 Expiratory tube
12 Flow sensor
13 PEEP/Pmax valve
1.0No.0312_0000001949_Publication
14 Expiratory valve
15 APL bypass valve
16 APL valve
17 Non-return valve
18 Absorber
Manual ventilation: Inspira- During inspiration, expiratory valve 14 remains closed. When the operator
tion 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 ventila-
tion 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.
Manual ventilation: Expira- During expiration, the inspiratory valve remains closed thus preventing the
tion – Cosy 2.6 breathing expiratory gas from flowing back into the inspiratory branch.
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.
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 isola-
tion 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.
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.
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 inter-
face.
Volume/pressure control During inspiration, the PEEP/Pmax valve remains closed. The control pres-
ventilation mode: Inspira- sure present at the PEEP/Pmax valve varies with the set pressure limit
tion (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.
No.0312_0000001949_Publication
Volume/pressure control During expiration, the inspiratory valve remains closed thus preventing
ventilation mode: Expira- rebreathing into the inspiratory branch.
tion
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
non-return valve 17 into the anaesthetic gas scavenging system.
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 deliv-
ered 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 ver-
ify 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 move-
ment.
During inspiration, the ventilator delivers fresh gas at a given volume, pres-
sure 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 sensor is the same type as the one used for measur-
ing 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.0312_0000001949_Publication
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
1.0No.0312_0000001949_Publication
The top of the ventilator assembly (patient system) contains two valves:
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).
Item Designation
1 Screw
2 Spring
3 Crater
4 Washer
5 Valve disk
1.2 Auxiliary air valve The auxiliary air valve allows infeed of ambient air if the fresh gas supply is
inadequate or the medical gas supply and/or the Fabius fail(s). The opening
pressure of this valve is -8 mbar.
Item Designation
No.0312_0000001949_Publication
1 Threaded ring
2 Valve disk
3 Valve cross with spring
4 Connecting screw
2 Pneumatic assembly The pneumatic assembly provides pressure for the PEEP valve control, and
also provides vacuum for the ventilator bag-type rolling seals and the APL
bypass valve control.
2.1 PEEP/Pmax valve When the Fabius is operating in automatic mode, the pump on the pneumatic
control 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 propor-
tional 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 main-
tains the desired amount of PEEP during patient expiration. The volume V1+
V2 smoothes out pressure fluctuations caused by the pump on the pressure
side. See Fig. 14.
2.2 APL bypass valve When the Fabius is operating in automatic ventilation mode, the pneumatic
control assembly provides a vacuum signal to hold open the APL bypass valve in the
compact breathing system.
The volume V2 smoothes out pressure fluctuations on the intake side (old
version). The fixed metering smoothes out pressure fluctuations (new ver-
sion). 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).
When the device is operating in manual ventilation mode, the pump on the
pneumatic assembly (and the ventilator) is stopped, and the spring-loaded
APL bypass valve in the breathing system closes, directing exhaled gas
through the APL valve.
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3 Function descrip- The supply gases flow through the filters and non-return valves in the gas
tion of the gas box inlet assembly. Pipeline supply pressures are indicated on pipeline manome-
ters located on the flowmeter assembly. Cylinder manometers are located on
the trolley assembly. The pressures of O2 and N2O delivered to the flowme-
ter 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.
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 anaes-
thetic vaporizer. This avoids an increase in anaesthetic gas concentration.
1.0No.0312_0000001949_Publication
4 SORC (Sensitive The SORC is a control element. The SORC makes sure the fresh gas always
Oxygen Ratio Con- contains a vital O2 concentration.
troller)
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 21 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 21 vol.%.
The SORC bypass valve allows the oxygen to bypass the resistor in the
SORC when O2 flows above 10 L/min are needed.
The O2 and N2O flows are adjusted with the flow control valves.
The resistors and the spring force are dimensioned such that a minimum con-
centration of 21 vol.% of O2 is always ensured. The maximum O2 flow is
approx. 12 L/min.
No.0312_0000001949_Publication
Item Designation
1 Control diaphragms
2 Resistors
3 N2O non-return valve
4 Operating-point adjusting screw
5 Flow control valves
1.0No.0312_0000001949_Publication
5 Cosy 2.6 breathing The Cosy 2.6 breathing system is a semi-enclosed system.
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
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.0312_0000001949_Publication
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
1.0No.0312_0000001949_Publication
12 Absorber
13 Breathing bag terminal and standby holder for Y-piece
14 Breathing bag hook
15 Flow sensor (Spirolog) (not shown)
16 Expiratory connection
Item Designation
17 Expiratory valve
7 Semi-open adapter The semi-open adapter is used in conjunction with the Cosy 2.6 patient sys-
tem.
7.1 Manual ventilation: The item numbers mentioned in the following paragraphs refer to Fig. 21.
General information
During manual ventilation, the APL valve 10 is set to the „MAN“ position. The
safety valve of the ventilator 4 is additionally active. The ventilator's piston
has moved to a lower position.
7.2 Manual ventilation: When the operator compresses the breathing bag 1 the gas mixture (expira-
Inspiration tory gas and fresh gas 2) flows through the fresh gas decoupling valve 3, the
inspiratory valve 5 and the O2 sensor 7 into the patient’s lung 8.
The pressure sensor 6 measures the airway pressure. The pressure exerted
on the manual breathing bag 1 closes the exhaust gas scavenging line in the
semi-open adapter 12. The ventilation pressure is limited by the APL valve
10. Any excess amount of the gas mixture flows through the APL valve 10
into the anaesthetic gas scavenging system 11.
7.3 Manual ventilation: The item numbers mentioned in the following paragraphs refer to Fig. 22
Expiration
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
same time, new fresh gas 2 flows into the manual breathing bag 1.
7.4 Spontaneous brea- The item numbers mentioned in the following paragraphs refer to Fig. 23.
thing: General infor-
mation 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.
7.5 Spontaneous brea- During inspiration, the expiratory valve 10 remains closed thus preventing
thing: Inspiration rebreathing of expiratory gas containing CO2.
The patient inhales the gas mixture and fresh gas 2 from the manual brea-
thing 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 sen-
sor 6 measures the airway pressure.
Any excess amount of the gas mixture flows into the anaesthetic gas scav-
enging system 12 and13.
7.6 Spontaneous brea- The item numbers mentioned in the following paragraphs refer to Fig. 24.
thing: Expiration
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 man-
ual 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.
8 Wall-mounted unit The wall version of the Fabius plus does not include the trolley.
8.1 Introduction The following describes the rotation function of the wall-mounted unit.
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.
No.0312_0000001949_Publication
3 Control unit The control panel comprises a graphical display, a membrane keypad, a
rotary encoder and a loudspeaker.
Data and power for the display comes from the Control PCB via a 20-conduc-
tor 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.
Item Function
1 Selects volume controlled ventilation mode
Item Function
7 Programmable keys: Activate the corresponding function that
appears on screen above the key
8 For setting alarm limits
4 Battery backup The Fabius backup power is provided by two series-connected, 12-V
rechargeable batteries. These batteries remain on charge as long as the
device is connected to a live mains supply. Should power supply fail while the
device is in operation, the batteries will allow the device to continue operating
for a minimum of 45 minutes, provided that the batteries are fully charged.
The batteries are located inside the control box. The 3.15 A battery fuse is
located at the rear of the control box.
No.0312_0000001949_Publication
5 FiO2 measurement The O2 sensor measures the O2 concentration in the respiratory gas (FiO2).
The O2 sensor contains a capsule with alkaline electrolyte, a lead anode, two
gold cathodes, and a Teflon membrane. The spatial separation of the two
gold cathodes allows to carry out a voltage comparison.
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 cath-
odes and the lead anode. This resistance is approximately 700 ohms.
ated. 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.
6 Respiratory Flow The flow sensor functions according to the constant temperature hot-wire
Measurement anemometer principle. Respiratory gas flows past a thin platinum wire. This
platinum wire (Fig. 33/A) is located in a measuring tube and is electrically
heated. The platinum wire is held at a constant temperature. Gas flow
removes heat from the hot wire. The higher the gas flow rate, the greater the
heat removal. The amount of electrical current needed to maintain a constant
platinum wire temperature is thus proportional to the gas flow rate.
A second platinum wire (Fig. 33/B) in the measuring tube is used to compen-
sate for interference from different gases present in the respiratory gas. The
heat removed from the second platinum wire is measured during inspiration
when the gas flow is zero.
The different gases present in the respiratory gas have a different thermal
conductivity. The amount of heat removed from the second platinum wire is
thus an indicator of respiratory gas composition.
Internal calibration tables for O2/N2O mixtures, Air and 100% O2 are used to
linearize the measured flow.
Item Designation
„A“ Platinum wire „A“
„B“ Platinum wire „B“
No.0312_0000001949_Publication
Parts catalog
Test Instructions
This chapter contains the measures required to determine the actual condi-
tion of the device.
Annex 51
No.0312_0000001949_Publication
Fabius plus
Revision: 06
2010-06-11
5330.450
1/70
Parts catalog
Maintenance parts/Service kits
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
2/70
Parts catalog
Option, Drägersorb Clic
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
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Revision: 06
3/70
Parts catalog
Sets and spare parts
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
4/70
Parts catalog
Fabius GS(APL By-A ), 2-yearly
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
5/70
Parts catalog
Fabius GS(APL By-N ), 2-yearly
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
6/70
Parts catalog
Fabius GS, 3-yearly
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
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Revision: 06
7/70
Parts catalog
Fabius GS, yearly
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
8/70
Parts catalog
Fabius GS, no Batt.,3-yearly
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
9/70
Parts catalog
Cosy2 holder
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
10/70
Parts catalog
Vapor,plug-in con.,double,auto
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
11/70
Parts catalog
Vapor, plug-in connector S
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
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Revision: 06
12/70
Parts catalog
Vapor, plug-in connector
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
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Parts catalog
Vapor,plug-in con.,triple,auto
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
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Revision: 06
14/70
Parts catalog
gas box
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
15/70
Parts catalog
Flowmeter block
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
16/70
Parts catalog
Flowmeter block
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
17/70
Parts catalog
Flowmeter block
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
18/70
Parts catalog
Control box
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
19/70
Parts catalog
pneumatic
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
20/70
Parts catalog
Rear panel
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
21/70
Parts catalog
Gas block
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
22/70
Parts catalog
Ventilator
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
23/70
Parts catalog
Ventilator
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
24/70
Parts catalog
Breathing system COSY 2.6
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
25/70
Parts catalog
Breathing system COSY 2.6
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
26/70
Parts catalog
Breathing system COSY 2.6
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
27/70
Parts catalog
Breathing system COSY 2.6
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
28/70
Parts catalog
Breathing system COSY 2.6
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
29/70
Parts catalog
Trolley
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
30/70
Parts catalog
Accessories/ consumables
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
31/70
Parts catalog
Accessories/ consumables
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
32/70
Parts catalog
Accessories/ consumables
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
33/70
Parts catalog
Hose DIN, device NIST
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
34/70
Parts catalog
Hose DISS, device NIST
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
35/70
Parts catalog
Clutch adapter
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
36/70
Parts catalog
Without plug, no color
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
37/70
Parts catalog
Without plug, color EN 739
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
38/70
Parts catalog
AIR
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
39/70
Parts catalog
AIR/O2
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
40/70
Parts catalog
N2O
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
41/70
Parts catalog
O2
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
42/70
Parts catalog
AIR/O2
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
43/70
Parts catalog
O2
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
44/70
Parts catalog
VAC
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
45/70
Parts catalog
AIR/O2
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
46/70
Parts catalog
N2O
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
47/70
Parts catalog
AIR
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
48/70
Parts catalog
AIR/O2
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
49/70
Parts catalog
N2O
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
50/70
Parts catalog
O2
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
51/70
Parts catalog
VAC
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
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Revision: 06
52/70
Parts catalog
Central Air distributor
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
53/70
Parts catalog
Central O2 distributor
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
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Revision: 06
54/70
Parts catalog
Modification kits/Options
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
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55/70
Parts catalog
Modification kits/Options
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Parts catalog
Sets and spare parts
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
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Parts catalog
Pressure reducer
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
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Parts catalog
Aux. outlet strips
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
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Parts catalog
Aux. outlet strips
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
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60/70
Parts catalog
Bronch succ. system
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
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61/70
Parts catalog
vac./eject. succ.system
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62/70
Parts catalog
vac./eject. succ.system
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63/70
Parts catalog
vac./eject. succ.system
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
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64/70
Parts catalog
Kuhn system
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
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Revision: 06
65/70
Parts catalog
Pressure gauge
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
66/70
Parts catalog
Software
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
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Revision: 06
67/70
Parts catalog
Flexible bag arm
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
68/70
Parts catalog
Halogen lamps
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
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Revision: 06
69/70
Parts catalog
Pin Index option
Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
Fabius plus
Revision: 06
70/70
Test instructions / Service Card IPM
Fabius plus
NOTE
– Prior to using these test instructions, check that they are the latest revi-
sion (compare revision with current service documentation).
– All results and inputs must be documented in the „Test Report“ or „Result
Sheet“, as applicable.
NOTE
Do not use these test instructions for testing after a repair procedure.
For the devices listed below, use the test instructions specific to the relevant
device:
– Vapor 19.n
– Vapor 2000
– Devapor
– Connected monitoring systems
Conversion table: 1bar = 14,504 PSI / 1mbar = 1,01973 cm H2O.
17.11.09_0000000699_Publication
17.11.09_0000000699_Publication
Table of contents
1 Device configuration 7
1.1 Basic device configuration ........................................................................................................ 8
1.1.1 Serial number / software (if not otherwise recorded).................................................. 8
2 Maintenance parts 9
2.1 Maintenance parts, every 12 months ....................................................................................... 10
2.1.1 Service set for Fabius................................................................................................. 10
2.2 Service parts, 2-yearly .............................................................................................................. 10
2.2.1 Fabius service set with APL bypass valve (old) ......................................................... 10
2.2.2 Fabius service set with APL bypass valve (new) ....................................................... 11
2.3 Service parts, 3-yearly .............................................................................................................. 11
2.3.1 Service set for Fabius................................................................................................. 11
2.4 Inlet pressure regulator test, 3-yearly ....................................................................................... 13
2.4.1 Downstream pressure of pipeline supply O2 inlet pressure regulator........................ 13
2.4.2 Downstream pressure of pipeline supply N2O inlet pressure regulator (not applicable 14
in nitrous-oxide-free mode)
2.5 Service parts, 6-yearly .............................................................................................................. 14
2.5.1 High-pressure cylinders option (SILVERLINE)........................................................... 14
2.6 Service parts as required.......................................................................................................... 15
2.6.1 Breathing system........................................................................................................ 15
2.6.2 Ventilator .................................................................................................................... 16
2.6.3 Optional anesthetic gas scavenging system (AGSS)................................................. 16
3 Electrical safety 17
3.1 Electrical safety, base unit, to DIN EN 62353 (IEC 62353) ...................................................... 18
3.1.1 Notes on the „Electrical safety to DIN EN 62353“ section.......................................... 18
3.1.2 Visual check ............................................................................................................... 18
3.1.3 Protective conductor resistance ................................................................................. 19
3.1.4 Protective conductor resistance measuring points..................................................... 20
3.1.5 Device leakage current............................................................................................... 20
3.2 Option: Electrical safety, power supply unit, to DIN EN 62353 (IEC 62353) ............................ 22
3.2.1 Visual check ............................................................................................................... 22
3.2.2 Protective conductor resistance ................................................................................. 22
3.2.3 Protective conductor resistance measuring points..................................................... 23
3.2.4 Device leakage current............................................................................................... 24
3.3 Electrical safety according to IEC 60601-1............................................................................... 25
3.3.1 Base unit .................................................................................................................... 25
3.3.2 Protective conductor resistance ................................................................................. 26
3.3.3 Ground leakage current.............................................................................................. 27
3.3.4 Optional power supply unit heater, protective earth conductor resistance................. 28
3.3.5 Optional power supply unit heater, earth leakage current.......................................... 29
17.11.09_0000000699_Publication
17.11.09_0000000699_Publication
Fabius plus
NOTE
The serial number is located on the side of the breathing system.
17.11.09_0000000699_Publication
Fabius plus
NOTE
Maintenance parts of shorter intervals, as applicable, must also be taken
into consideration.
NOTE
Maintenance parts of shorter intervals, as applicable, must also be taken
into consideration.
This service set (quantity 1) with the number MX08153 includes the following
17.11.09_0000000699_Publication
items:
17.11.09_0000000699_Publication
Fabius plus
Item Designation
1 N2O outlet (to the N2O flow-control valve)
2 Gas inlet assembly
3 N2O inlet pressure regulator
4 O2 inlet pressure regulator
5 O2 outlet (to the O2 flow-control valve)
6 T-connector (7901458)
7 to the O2 flow-control valve
8 to the N2O flow-control valve
9 Digital manometer (7910724)
• Close the O2 flow control valve and disconnect the O2 pipeline supply tube
from the inlet.
• Remove the test equipment, and then reconnect the O2 pressure tube
leading from the O2 flow control valve to the O2 connector on the inlet
block.
NOTE
Maintenance parts of shorter intervals, as applicable, must also be taken
into consideration.
Fabius plus
NOTE
O2 sensors are special waste. Dispose of the O2 sensors according to local
waste disposal regulations.
tity
1 Ventilator tube Breathing system
2.6.2 Ventilator
17.11.09_0000000699_Publication
Fabius plus
3.1 Electrical safety, base unit, to DIN EN 62353 (IEC 62353) ...................................................... 18
3.2 Option: Electrical safety, power supply unit, to DIN EN 62353 (IEC 62353) ............................ 22
3.3 Electrical safety according to IEC 60601-1............................................................................... 25
17.11.09_0000000699_Publication
NOTE
The device conforms to the conditions of protection class I, type B.
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 μA, check the tester configuration in addition to the test setup!
NOTE
The following presents a description of the electrical safety tests according
to DIN EN 62353 (IEC 62353). Whether the standard is applicable or not de-
pends on national regulations and its use must be decided on site under
consideration of applicable national regulations.
NOTE
– In testing to DIN EN 62353, not only the medical electrical device (ME
device) but also the medical 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
manufacturer, of which at least one must be an ME device, which are
interconnected by a functional connection or by means of 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 safe-
ty check, in order to avoid incorrect measurements.
WARNING!
Hazardous voltage.
Touching live components can lead to serious injury or death.
– Disconnect the power cord from the AC outlet before checking the power
17.11.09_0000000699_Publication
fuse-links.
Test – The power fuse-links of the device under test match the specifications on
the rating plate.
– The power cable and plug are not dirty or damaged.
Fabius plus
Item Designation
1 Tester, e.g. SECUTEST
2 Device under test
3 Tester probe cable
L Conductor
N Neutral conductor
PE (Protective earth) conductor
• Configure the tester appropriately and follow the instructions on the tester.
• Using the tip of the probe cable, scan each measurement points listed in
section "Protective conductor resistance measuring points" on the device
under test 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.
Entry Maximum measured value of device with power supply cord.
17.11.09_0000000699_Publication
[________Ohm]
Test In devices with detachable mains power cables calculate the protective earth
conductor resistance using the following formula:
Calculated value of the device without mains power cable = (maximum mea-
sured value of the device with mains power cable) minus (maximum mea-
sured value of the mains power cable).
The calculated value of the device without mains power cable must not
exceed 0.2 Ohm.
Result Calculated value of the device without mains power cable.
[________Ohm]
or
Test The protective conductor resistance of ME systems (including mains power
cable) must not exceed 0.5 Ohm in each case.
Entry Maximum measured value of ME system.
[________Ohm]
Fabius plus
Test set-up
Item Designation
1 Tester, e.g., SECUTEST
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
NOTE
The test must be performed twice! The second test is performed with the
plug reversed 180° in the socket. In many test devices the mains plug rota-
tion 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 μA.
Entry Recurrent measurement
[________μA]
NOTE
The device conforms to the conditions of protection class I, type B.
Test – The power fuse-links of the device under test match the specifications on
the rating plate.
– The power cable and plug are not dirty or damaged.
Result Condition checked.
[________OK]
Item Designation
1 Tester, e.g. SECUTEST
2 Device under test
3 Tester probe cable
L Conductor
N Neutral conductor
17.11.09_0000000699_Publication
Fabius plus
• Configure the tester appropriately and follow the instructions on the tester.
• Using the tip of the probe cable, scan each measurement points listed in
section "Protective conductor resistance measuring points" on the device
under test 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.
Entry Maximum measured value of device with power supply cord.
[________Ohm]
Test In devices with detachable mains power cables calculate the protective earth
conductor resistance using the following formula:
Calculated value of the device without mains power cable = (maximum mea-
sured value of the device with mains power cable) minus (maximum mea-
sured value of the mains power cable).
The calculated value of the device without mains power cable must not
exceed 0.2 Ohm.
Result Calculated value of the device without mains power cable.
[________Ohm]
or
Test The protective conductor resistance of ME systems (including mains power
cable) must not exceed 0.5 Ohm in each case.
Entry Maximum measured value of ME system.
[________Ohm]
Item Designation
1 Tester, e.g., SECUTEST
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
NOTE
The test must be performed twice! The second test is performed with the
plug reversed 180° in the socket. In many test devices the mains plug rota-
tion is simulated by means of a built-in selector switch. The higher measured
value must be documented.
NOTE
17.11.09_0000000699_Publication
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!
Fabius plus
Test The reference value must not exceed 500 μA.
Test The recurrent measurement value must not exceed 500 μA.
Entry Recurrent measurement
[________μA]
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).
– With devices that are connected to other devices by means of a data
cable, this connection must be disconnected prior to performing the elec-
trical safety check, in order to avoid incorrect measurements.
Item Designation
1 Tester, e.g. SECUTEST, 7910594
2 Fabius under test
3 Test probe with tip (e.g. SECUTEST accessories)
L Conductor
N Neutral conductor
PE (Protective earth) conductor
Fabius plus
Item Designation
1 Tester, e.g. SECUTEST, 7910594
2 Fabius under test
L Conductor
N Neutral conductor
PE (Protective earth) conductor
Test In single fault condition (S.F.C.), the value must not exceed 1000 μA.
Entry Single fault condition (S.F.C.)
[________μA]
3.3.4 Optional power supply unit heater, protective earth conductor resis-
tance
Test set-up
Item Designation
1 Tester, e.g. SECUTEST, 7910594
2 Power supply unit heater under test
3 Test probe with tip (e.g. SECUTEST accessories)
L Conductor
N Neutral conductor
PE (Protective earth) conductor
Fabius plus
Item Designation
1 Tester, e.g. SECUTEST, 7910594
2 Power supply unit heater under test
L Conductor
N Neutral conductor
PE (Protective earth) conductor
Test In single fault condition (S.F.C.), the value must not exceed 1000 μA.
Entry Single fault condition (S.F.C.)
[________μA]
Action • Switch off the SECUTEST and the power supply unit heater.
17.11.09_0000000699_Publication
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Fabius plus
Entry [________OK]
Action • Reconnect the expiratory hose to the expiratory connection of the breath-
ing system.
4.2.5 Fresh gas leakage test (with and without anesthetic vaporizer)
NOTE
Carry out this test once with the anesthetic vaporizer fitted and once without
anesthetic vaporizer.
Test set-up
Item Designation
1 Digital manometer 7910722
2 Fresh gas tube
3 Kuhn connector M28189
4 T-piece 6800187
5 Blower ball M16118
Action • Connect the fresh gas tube to the breathing system (COSY).
Test set-up
Item Designation
1 Digital manometer 7910722
2 Fresh gas tube
3 Kuhn connector M28189
4 T-piece 6800187
5 Blower ball M16118
Entry 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".
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.
must be performed.
Attach breathing hose from expira- Connect the expiratory valve and the
tory valve to inspiratory valve and inspiratory valve with the breathing
remove breathing bag. system tube, and remove the breath-
ing bag.
Touch "Calibrate" key. Press the „Calibrate” key.
At completion of calibration "Calibra- After completion of the calibration,
tion" shall indicate Pass/Fail. „Calibrate”must display „Pass” or
„Fail”.
Remove O2 cell from housing. Remove the O2 cell from the hous-
ing.
Let current cell valus stabilize. Wait for the values to stabilize.
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Touch "Store Zero" key to enter the Press the „Store Zero” key to store
current values as the calibration the current values as calibration
zero. 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.
• Press the "Exit" key.
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.
Entry [________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.
17.11.09_0000000699_Publication
NOTE
Reset "O2 whistle" to customer settings.
Fabius plus
Item Designation
1 O2 sensor
2 Connector M27961
3 Test adapter 7900138
4 Tube
5 Kuhn connector M2796
6 Fresh-gas tube
4.7.1 Fresh gas leakage test (with and without anesthetic vaporizer)
NOTE
Carry out this test once with the anesthetic vaporizer fitted and once without
anesthetic vaporizer.
Test set-up
Item Designation
1 Digital manometer 7910722
2 Fresh-gas tube
3 Kuhn connector M28189
4 T-piece 6800187
5 Blower ball M16118
Fabius plus
Test set-up
Item Designation
1 Digital manometer 7910722
2 Fresh-gas tube
3 Kuhn connector M28189
4 T-piece 6800187
5 Blower ball M16118
4.8.1 Testing the pipeline supply leakage and the pipeline supply manom-
eters
Test set-up
Item Designation
1 Test cylinder
2 High-pressure regulator
3 Test adapter (7901495)
4 Device inlet
5 O2 pipeline supply
Action • Close the cylinder valves of the PIN index and high-pressure cylinders.
• Disconnect cylinders from Fabius.
• Bleed the pressure in the system by opening all flow valves.
Test The pipeline supply manometers do not indicate any pressure.
Close all flow control valves.
Action • Connect the test cylinder and gas manifold, one after the other, to the
respective pipeline supply gas inlet on the device.
• Open the valve of the test cylinder.
• Set a pressure of of 5 bar.
Test The indicator of the relevant manometer is in the green working range of 2.8
to 6.0 bar.
Action • Close the valve of the test cylinder.
Test The high-pressure manometer of the test pressure regulator must not drop by
more than 10 bar within 2 minutes.
Entry O2 manometer / O2 leakage
[________OK]
Fabius plus
Item Designation
1 Test connector M13506
2 Digital manometer 7910722
Pmax = 70 mbar
Vt = 1400 mL
Freq = 4 BPM
TI:TE = 1:1
TIP:TI = 0%
PEEP = 0 mbar (cmH2O)
Result [________OK]
pmax = 70 mbar
Fabius plus
Vt = 380 mL
Freq = 12 BPM
TI:TE = 1:1
TIP:TI = 10%
PEEP = 0 mbar
Item Designation
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1 Flowmeter (7901161)
2 Connecting sleeve (M13506)
3 Reducing sleeve (7900034) / N2O adapter / AIR adapter
Action • Connect
Fabius plus the O2/N2O high-pressure cylinder available 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 O2/N2O high-pressure cylinder available.
Test The flow rate indicated on the flowmeter (1) is less than/equal to 5 mL/min.
Entry Pipeline supply O2 connector max. 5 mL/min.
[________mL/min]
Action • Remove the existing O2/N2O high-pressure cylinder 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 cyl-
inder connectors on the gas inlet block.
Test The flow rate indicated on the flowmeter (1) is less than/equal to 5 mL/min.
Entry O2 high-pressure cylinder connector max. 5 mL/min.
[________mL/min]
Item Designation
1 Adapter O2 DIN/NIST M32366 und connector 7901433
Test The blow-off valve opening pressure at the N2O high-pressure regulator
should be 7.5 to 8.0 bar (not applicable in nitrous-oxide-free mode).
Result N2O blow-off valve opening pressure.
[________bar]
17.11.09_0000000699_Publication
Fabius plus
Item Designation
1 Test pressure regulator 7901482
2 Reducer 7900044
3 Connector 7901430
4 PU tube, 2.7 mm, 1194925
5 Adapter 7901435 (installed on the high-pressure regulator instead of
the hexagon socket screw)
6 High-pressure regulator
7 Distributor V04380
Result
[________OK]
Fabius plus
Fabius plus
Fabius plus
Fabius plus
Order number: 9500470
Key
9 / OK = OK
Applies to Test instructions / Service Card IPM Revision 1.n + = Spare part used
! = Error / Report
/ = Accessory not available
- = Not applicable
OK Result OK Result
1 Device configuration 3.1.3 Protective conductor resistance
1.1 Basic device configuration
3.1.3.1 Maximum measured value of device with pow- Ohm
er supply cord.
1.1.1 Serial number / software (if not otherwise record-
ed)
3.1.3.2 Maximum measured value of power cable. Ohm
1.1.1.1 Serial number of the unit txt
3.1.3.3 Calculated value of the device without mains Ohm
power cable.
1.1.1.2 Serial number of the breathing system (Cosy) txt
txt
3.1.3.4 Maximum measured value of ME system. Ohm
1.1.1.3 Serial number of optional bronchial suction de-
vice
3.1.4 Protective conductor resistance measuring OK
2 Maintenance parts points
2.2.1 Fabius service set with APL bypass valve (old) dat 3.2 Option: Electrical safety, power supply unit, to DIN
EN 62353 (IEC 62353)
2.2.2 Fabius service set with APL bypass valve (new) dat
3.2.1 Visual check OK
2.3 Service parts, 3-yearly
3.2.2 Protective conductor resistance
2.3.1 Service set for Fabius dat
3.2.2.1 Maximum measured value of device with pow- Ohm
2.4 Inlet pressure regulator test, 3-yearly er supply cord.
2.4.1 Downstream pressure of pipeline supply O2 inlet OK
3.2.2.2 Maximum measured value of power cable. Ohm
pressure regulator
3.2.2.3 Calculated value of the device without mains Ohm
2.4.2 Downstream pressure of pipeline supply N2O in- OK power cable.
let pressure regulator (not applicable in nitrous-
oxide-free mode)
3.2.2.4 Maximum measured value of ME system. Ohm
4.7 Basic unit O2 flush / fresh-gas leakage 4.12.7 O2/N2O high-pressure regulator performance test
(every three years)
4.7.1 Fresh gas leakage test (with and without anesthet-
ic vaporizer)
4.12.7.1 O2 high-pressure regulator performance OK
4.7.1.1 Fresh gas leakage with Vapor. mbar
4.12.7.2 N2O high-pressure regulator performance (not OK
applicable in nitrous-oxide-free mode)
4.7.1.2 Fresh gas leakage without Vapor. mbar
4.13 Final action
4.7.2 Nitrous-oxide-free option: Fresh-gas leakage test
4.13.1 Device handover with test label OK
4.7.2.1 Fresh-gas leakage mbar
5 Test equipment
4.8 Testing the gas inlet block
5.1 Test equipment
4.8.1 Testing the pipeline supply leakage and the pipe-
line supply manometers 5.1.1 Test equipment subject to mandatory calibration
4.8.1.1 O2 manometer / O2 leakage OK
5.1.1.1 Valid calibrated test equipment used OK
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Revision 1.0
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No.0312_0000001949_Publication