Fabian +nCPAP Evolution: Service Manual

fabian +nCPAP evolution
Ref: 122001
Prefix: AN
Service Manual
SM Rev. 2.0
fabian +nCPAP evolution | SM-Rev.2.0

Ref: 122010.02EN / Date: 24.04.2019
Sales and Service Information
Sales and Service Information

The ACUTRONIC Medical Systems AG sales and service centre network is world-wide. For the address of your
local distributor, contact your nearest ACUTRONIC Medical Systems AG subsidiary. In case of difficulty a
complete list of all distributors and subsidiaries is provided on our internet site: http://www.acutronic-
medical.ch.
Sales information can also be obtained from:
sales@acutronic-medical.ch
Address Headquarter
ACUTRONIC Medical Systems AG
Fabrik im Schiffli
8816 Hirzel / Switzerland
Phone: +41 44 729 70 80

Fax: +41 44 729 70 81
E-Mail: info@acutronic-medical.ch
www.acutronic-medical.ch
2 / 99 fabian +nCPAP evolution | SM-Rev. 2.0

Ref: 122010.02EN / Date: 24.04.2019
Table of Contents
Table of Contents
Sales and Service Information .................................................................... 2
Table of Contents........................................................................................ 3
1 Preface ....................................................................................... 5
1.1 Document Structure .......................................................................................................5
1.2 List of abbreviations........................................................................................................6
1.3 Service manual revision history.....................................................................................6
2 Hardware information................................................................ 7
2.1 Serial number description..............................................................................................7
2.2 Hardware Revision History .............................................................................................7
3 Important preliminary remarks .................................................. 8

3.1 ESD Precautions ..............................................................................................................8
3.2 Warranty ...........................................................................................................................8
3.3 Liability for functionality damages................................................................................8
3.4 Service, Repair, Maintenance, Calibration & Testing ..................................................9
3.5 Contact .............................................................................................................................9
4 System overview .......................................................................10

4.1 Manifold user side ........................................................................................................ 11
4.2 Rear panel ..................................................................................................................... 12
4.2.1 External alarm connector (Nurse call) ........................................................................................................... 13
4.2.2 Connector for 12 - 24 VDC ................................................................................................................................ 13
4.3 Hardware components ................................................................................................ 14
4.3.1 Mainboard............................................................................................................................................................ 14
4.3.2 NetDCU ................................................................................................................................................................. 16
4.3.3 Power module ..................................................................................................................................................... 17
4.3.4 Manifold................................................................................................................................................................ 20
4.3.5 O2 sensor .............................................................................................................................................................. 22
4.3.6 Proportional gas blender ................................................................................................................................. 24
4.4 Internal tubing .............................................................................................................. 27
4.5 PDMS/ Network/ acuLink connection ....................................................................... 29
5 Failure analysis .........................................................................30

5.1 Alarms messages on device ........................................................................................ 30
5.2 Power PCB - status LEDs and fuses ............................................................................ 32
5.3 Mainboard - watchdog LEDs ....................................................................................... 33
5.4 Software watchdog ...................................................................................................... 34
5.5 Alarm messages about the Proportional Gas Blender ............................................ 34
fabian +nCPAP evolution | SM-Rev. 2.0 3 / 99

Ref: 122010.02EN / Date: 29.09.2018
Table of Contents
5.6 Trends, Log files, Device info....................................................................................... 36
6 Calibration and Service information ..........................................41

6.1 System and service information ................................................................................. 42
6.2 Calibration submenu ................................................................................................... 46
6.3 Blenderboard submenu .............................................................................................. 46
6.4 MonitorPIC submenu ................................................................................................... 47
6.4.1 Inspiratory pressure (P-insp or P-MIX) calibration to 0mbar .................. Error! Bookmark not defined.
6.4.2 Inspiratory pressure (P-insp or P-MIX) calibration to 60mbar ................ Error! Bookmark not defined.
6.4.3 Input pressure regulator calibration ............................................................ Error! Bookmark not defined.
6.5 Valves submenu............................................................................................................ 48
6.6 Display submenu .......................................................................................................... 49
6.7 Settings submenu ........................................................................................................ 51
6.8 Licensing submenu and License handling ................................................................ 53
6.9 Maintenance submenu ................................................................................................ 56
7 Software update .......................................................................58
8 Servicing ...................................................................................59
8.1 Cleaning and disinfection ........................................................................................... 59
8.2 Transportation .............................................................................................................. 59
8.3 List of the test equipment and special tools............................................................. 59
8.4 Alarms off....................................................................................................................... 60
8.5 Service-Password off.................................................................................................... 60
8.6 Spare parts list .............................................................................................................. 60
8.7 Handling of the used components ............................................................................ 60
9 Repair and various replacements/ Disassembly and assembly ..61

9.2 Housing removal .......................................................................................................... 65
9.2.2 Remove the Loudspeaker and Fan module ................................................................................................. 75
9.2.3 Complete Front Panel removal ....................................................................................................................... 91
9.3 Device check ................................................................................................................. 98
9.3.1 Battery calibration ............................................................................................................................................. 98
10 Technical Specifications ............................................................99

10.1 Ambient Conditions ..................................................................................................... 99
10.2 Dimensions / Weight .................................................................................................... 99
10.3 Ratings ........................................................................................................................... 99

Ref: 122010.02EN / Date: 24.04.2019
1. Preface
1 Preface
This service manual is intended for use by ACUTRONIC Medical Systems AG trained and authorized service
personnel.
ACUTRONIC Medical Systems AG does not condone or approve of service activity on its products by other
than ACUTRONIC Medical Systems AG trained or authorized personnel and ACUTRONIC Medical Systems AG
is not responsible for any unauthorized repairs or modifications, or any repairs or modifications made by
unauthorized procedures.
Use of the incorrect part, or failure to exercise due care in the installation, removal, servicing, checkout or
calibration of parts and equipment or the use of unauthorized accessories, may result in damage to the
equipment which may in turn result in damage in property and injury (including death) to persons. The
purchaser and installer of these parts shall bear full responsibility and liability for the above.
All maintenance performed within the applicable warranty period must be authorized in advance by an
ACUTRONIC Medical Systems AG service representative in order to retain the warranty status of the subject
unit.
1.1 Document Structure
Please carefully read the Service manual before using or servicing the ventilator.
The table of contents will assist you in quickly locating the respective topic.
fabian +nCPAP evolution | SM-Rev.2.0

Ref: 122010.02EN / Date: 24.04.2019
1. Preface
1.2 List of abbreviations

Abbreviations which are not generally known, but are used in this manual, are listed below.
CPAP Continuous Positive Airway Pressure

DIO Digital Input Output Interface Module
ESD Electrostatic Discharge
GUI Graphical User Interface
HL7 Health Level 7
IfU Instruction for Use
IVOI Protocol from Philips for Intellibridge/Vuelink
O2 Oxygen
P Pressure
PCB Printed Circuit Board
PDMS Patient Data Management System
PIF Parallel interface
RS232 Serial communication transmission of data
SpO2 Peripheral Oxygen Saturation
1.3 Service manual revision history

Version Change
1.00 • First edition
1.01 • Connection for nurse call

• Chapter – Calibration removed. Test and calibration now in separate document
• 6.1 Serial number description
1.02
• 7.1 Information maintenance internal battery
• 12.1.5 replacing internal battery
• Minor changes
1.03
• Chapter “SW update” revised
• Battery board now called “power board”
• Chapter 10.4 renamed in: Processor port connections
1.04
• Delete chapter 10.4.4 – 10-4.6 PIC processor upgrade
• See new document: “Processor update instruction”
• 8.5 RS232 not for CO2
• 8.5.2 power connector / corrected
• 8.6.2 NEW mainboard 1.3
• 8.8.2 blender V2
1.05
• 8.9 Internal tubing / NEW
• 10.2 removed. See new document: fabian update instruction
• 10.3.4 Removed. See new document: Processor update instruction
• 12.2 NEW. Error codes.
1.06 • Chapter 12.2 revised
1.07 • New Chapter 10.3 revised

• Complete revision
2.00 • Chapter varying
• Content modification

Ref: 122010.02EN / Date: 24.04.2019
2. Hardware information
2 Hardware information
2.1 Serial number description
Example 1: AN10AA-0001 (Before 1st of January 2016)
Example 2: AN-03002 (From 1st of January 2016)
A: only for internal use

N: Model N – fabian +nCPAP evolution
T – fabian Therapy evolution
H – fabian HFO
I – fabin HFOi
K – fabian HFO without HFO Module
10: HW Revision 10 – 1.0
11 – 1.1 etc.
AA: Date of manufacture A – January A - 2012
B – February etc. B – 2013 etc.
01: Sequential number
From 1st of January 2016 the serial number have been changed to AN, for the device and xxxxx is a sequential
number: AN-xxxxx
2.2 Hardware Revision History

Serial no.. Rev. Change
1.0 • Without external 12 – 24 VDC power capability. Connector is already

AN10xx-xxxx
mounted but not connected inside the unit.
AN11xx-xxxx 1.1
• External power connector with integrated filter
≥ AN11BB-0219 1.1
• Changing from “FAS” to “MIM” valves
≥ AN11CC-0497 1.1
• Colour coded internal tubing
≥ AN11FC-0597 1.1
• Adaptions in fan holder
≥ AN11KC-0727 1.1
• New Mainboard 2.0
≥ AN11ED-1119 1.1
• SD-card inserted
≥ AN11FD-1177 1.1
• New blender (new pressure input regulators Kuhnke)
AN12xx-xxxx 1.2
• New Mainboard 2.1
≥ AN12KD-1365 1.2
• New air filter (blue) build in in upper and lower cover
≥ AN-01657 -
• Changed the rotary knob to plastic
≥ AN-01804 -
• New front foil without edge around the display
≥ AN-01948 -
• New manifold with adapted fittings for the membrane holder
≥ AN-02135 -
• Blue Inspiratory port
≥ AN-03000 -
• New housing type (Hakama)
≥ AN03014 -
• New front foil
Ref: 122010.02EN / Date: 29.09.2018
3. Important preliminary remarks
3 Important preliminary remarks

3.1 ESD Precautions
Always take standard ESD precautions when working on fabian ventilator systems.
Ensure the ventilator is disconnected from the AC power supply before performing service or repairs or
maintenance.
3.2 Warranty
We warranty that this product is free from defects in material and workmanship and, when properly used,
will perform in accordance with applicable specifications. If within two years after the original shipment it is
found not to meet this standard, it will be repaired at Acutronic Medical Systems AG, or replaced at no charge
when returned to an Acutronic Medical Systems AG service facility. Any modification to the equipment,
rework or repair by other than Acutronic Medical Systems AG approved personnel will render this warranty
null and void. Acutronic Medical Systems AG shall not be liable for any indirect, special or consequential
damages, even if notice has been given of the possibility of such damages.
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING, BUT NOT
LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
The policy of ACUTRONIC Medical Systems AG is to maintain product repair capability for a period of five
years after the official sales stop.
The two years warranty can only be guaranteed when the yearly maintenance with the preventive
maintenance kit was done. All maintenance performed within the applicable warranty period must be
authorized in advance by an ACUTRONIC Medical Systems AG service representative in order to retain the
warranty status of the subject unit.
3.3 Liability for functionality damages

The liability for proper function of the apparatus is irrevocably transferred to the owner or operator to the
extent the apparatus has been serviced or repaired by personnel not employed or authorised by ACUTRONIC
Medical Systems AG Service or when the apparatus was used in a manner not conforming to its intended use.
ACUTRONIC Medical Systems AG cannot be held responsible for damage caused by non-compliance with the
above-mentioned recommendations. The warranty and liability provisions of the terms of sale and delivery
of ACUTRONIC Medical Systems AG are likewise not modified by the recommendations mentioned above.
Description of:
Service: measures to maintain desired condition
Repair: to restore desired condition
Maintenance: inspection, service and if applicable, repair

Ref: 122010.02EN / Date: 24.04.2019
3. Important preliminary remarks
3.4 Service, Repair, Maintenance, Calibration & Testing

The Device is a ventilator classifies as Class IIb according to the European directive, as such:
• Inspection as per manufacturer specifications is required every 12 months
• Maintenance must be performed by Acutronic Medical System AG trained experts with
access to appropriate test and measuring equipment.
We strongly recommend Acutronic Medical System AG exclusive representatives for service agreements and
repairs.
Use only original Acutronic Medical System AG parts for repair.
Always clean and disinfect equipment or equipment components prior to any maintenance – including when
returning the equipment for repair.
Every 12 months
Perform the following work:
• Maintenance and safety inspections according to the following documents:
o TS-AA-17e, Calibration and Test instruction, See Software Release Package, website
o TS-FB-27e, Test protocol for service & maintenance, See Software Release Package, website
• Preventive Maintenance kit for the device, see “Spare Part Price List” on the website.
Every 4 years
Perform the following work:
• Maintenance and safety inspections according to the following documents:
o TS-AA-17e, Calibration and Test instruction, See Software Release Package, website
o TS-FB-27e, Test protocol for service & maintenance, See Software Release Package, website
• Preventive Maintenance kit for the device, see “Spare Part Price List” on the website.
Maintenance and the safety check may only be carried out by specialists trained by
Acutronic Medical System AG , who have suitable measuring equipment and test
facilities.
Original packaging should be kept for the possible return of the unit. Only original
packaging ensures optimal protection of the equipment during transport. If it is
necessary to return the equipment during the warranty period, the manufacturer is
not liable for damages caused by incorrect packaging.
Original packaging should be kept for the possible return of the unit. Only original packaging ensures optimal
protection of the equipment during transport. If it is necessary to return the equipment during the warranty
period, the manufacturer is not liable for damages caused by incorrect packaging.
3.5 Contact
Phone: +41 44 729 70 80
+41 44 729 70 86
E-mail: GMB-CH-AMS-Support@vyaire.com

Ref: 122010.02EN / Date: 29.09.2018
4. System overview
4 System overview
Acutronic fabian +nCPAP medical ventillator

Ref: 122010.02EN / Date: 24.04.2019
4. System overview
4.1 Manifold user side
1. Connectors on the Manifold (Photo and cross-section schematic)
Component name
1 Inspiratory tube port
2 Connection for nCPAP system based on flow generators (single limb systems)
3 Proximal pressure measuring tube port
4 Expiration tube port

5 Exhalation valve coil
6 Electronic safety valve coil
7 Safety valve (function: pneumatic pressure relief)
8 Pressure sensor

Ref: 122010.02EN / Date: 29.09.2018
4. System overview
9 Pressure sensor (P insp)
4.2 Rear panel
2. Connectors on the rear panel (photo and schematic)
1 Mains connection with fuse holder

2 Terminal studs for potential equalization
Connection for external voltage supply 12 – 24V DC
3
From HW- Rev. 1.0 use only VDC cable with Part No. 151401 (See spare parts list!)
4 Nurse call, max. Switching voltage 50 VDC
5 Flow sensor connector
Network connection for data management
6
( For connection to network with minimum 3 KV galvanic isolation)
USB connection for data output (log file) and system update;
7
Connection for Masimo SpO2 sensor module.
8 RS232 interface, service, PDMS

Ref: 122010.02EN / Date: 24.04.2019
4. System overview
9 Connection for compressed air supply 2.0 – 6.5 bar / 40 l/min

10 Oxygen sensor
11 Connection for oxygen “O2” supply 2.0 – 6.5 bar / 40 l/min
For adapting to the DISS system you need:
AIR adapter NIST-female to DISS-male / 90 degrees
O2 adapter NIST-female to DISS-male / 90 degrees
Warning: Do not connect Ethernet, Nurse call, USB, R232, Flow Sensor ports to
anything other than specified devices.
4.2.1 External alarm connector (Nurse call)

Plug:
Manufacturer: Binder
Series 712, 3 pins
PIN
2/1 Normal open (NO)
2/3 Normal Closed (NC)
4.2.2 Connector for 12 - 24 VDC

The fabian evolution can likewise be operated with an external power supply.
An external supply with a voltage of 12 – 24 volts must be connected to the back of the device in this case.
Plug:
Manufacturer: Binder
Series 680, 4 pins
PIN
3/4 12 - 24 V DC
1/2 GND

Ref: 122010.02EN / Date: 29.09.2018
4. System overview
4.3 Hardware components

4.3.1 Mainboard
3. Mainboard

Ref: 122010.02EN / Date: 24.04.2019
4. System overview
Marks in pictures Component name Comment

3. and 4.
1 NetDCU connector
2 Lithium Battery cell of the Real If the fabian does not show the correct time, even
Time Clock (Type CR2032) after refreshment, please exchange the battery of
the Real Time Clock.
3 UDP connector
4 Touch screen connector
5 Patient gas supply connector
6 Blender connector
7 Fan connector
8 Loud speaker connector
9 Backlight connector
10 Safety relays
11 LCD display connector
12 Flow sensor connector
13 Nurse call connector
14 O2 sensor connector
15 Programmer pin strips Monitor, Alarm-PIC, Boot, Conductor
16 Hardware version (HW-Rev) e.g: MIM Fabian Evolution V22 20160330, Rev.: 2.2
17 Power PCB connector
18 Keyboard connector
4. Hardware version sign on the Mainboard

Ref: 122010.02EN / Date: 29.09.2018
4. System overview
4.3.2 NetDCU
The NetDCU PCB can be found on the Mainboard, connected via pin strips. The NetDCU contains an
exchangeable SD memory card to store the trends, log files and special font characters. Log and trend files
can be exported via USB. The NetDCU uses embedded WinCE operation system, therefore the used USB
device has to be WinCE compatible (for example: USB1.1). For more information about the downloading of
the log files, trends and device information please see Chapter 4.6.
The Device ID of the fabian and licenses are stored in the inner memory of the NetDCU, therefore at replacing
the NetDCU module, the fabian will get a new device ID (and a new service-password) and the licenses has to
be reinstalled as well (See Licensing submenu and License handling, Chapter 5.8.).
5. NetDCU

Ref: 122010.02EN / Date: 24.04.2019
4. System overview
4.3.3 Power module

The device can be operated from an external power source, but features an internal battery (NiMH
Powerpack) also.
For detailed description on the topic please read the Battery operation Chapter in the IfU.
In this document the power module expression means the sum of the following components:
- Power PCB
- Powerpack NiMH/ Inner battery
- Power supply “XP”
- Power inlet module
The most important components of the Power PCB are shown on the picture below.
6. Power PCB
Numbers in
Comp. name on PCB Function
picture 6.
1 LED 1 “Power OFF” LED (See Chapter 4.2)
2 5V OK (See Chapter
LED 2
4.2)
3 12 V OK (See Chapter
LED 3
4.2)
4 Power board in normal condition
LED 4
(See Chapter 4.2)
5 LED 5 State of charge (See Chapter 4.2)
6 F3 (SMD, 3 AT, 125 V” MELF 6125” Fuse3: Safety OFF function (See Chapter 4.2)

Ref: 122010.02EN / Date: 29.09.2018
4. System overview
6.1mm x 2.7mm)
7 F2 (SMD, 3 AT, 125 V” MELF 6125” Fuse2: 24V connection (Power off alarm)
6.1mm x 2.7mm) (See Chapter 4.2)
8 AKKU NiMH Powerpack (Internal battery) connector
9 ICP2 programmer connector
10 External power supply connector
11 24V wires
12 Mainboard connection
e.g: MIM AKKU_EVOL V.2.1 04.06.2012 Hardware version (HW-Rev)
Exchange of the Powerpack (Internal battery) is part of the 4 year preventive maintenance.
7. Power supply “XP”
Power inlet module and Power Supply “XP” join to the same point of the back panel as ground potential
(Rear panel schematics above refers to it, as terminal studs for potential equalization).

Ref: 122010.02EN / Date: 24.04.2019
4. System overview
8. Power inlet module and Power supply “XP” connection with potential equalizator

Ref: 122010.02EN / Date: 29.09.2018
4. System overview
4.3.4 Manifold
In case of the failure of the Manifold please exchange the complete Manifold block, and do not disassemble
it. Except if the damage is occurred on the proximal connector, the expiration valve membrane, the ribbon
cable or the tubes. The exchange of the expiration valve membrane is part of the yearly preventive
maintenance.
9. Main components of the Manifold (Left: removed Manifod, Right: fabian without housing, Manifold is
still in its original position)
Numbers in Component name Comment

pictures 9. and 10.
1 Connection with the mainboard “Patient gas”
2 Expiratory port With expiratory valve and
membrane.
3 Manifold PCB See in picture 10.
4 Pressure sensor inspiratory (P insp) Tube G
5 Pressure sensor proximal (P prox) Tube Y
6 Purge flow Tube B
7 Inspiratory tube Tube R
8 Electromagnetic and pneumatic valves See in picture 1. with
number 5 and 6
9 Calibration potentiometer Pinsp 0mbar (clockwise +,
anticlockwise -)
10 Calibration potentiometer Pinsp 60mbar (clockwise +,
anticlockwise -)
Detailed description about the front side of the Manifold please see above (Chapter 4.1).

Ref: 122010.02EN / Date: 24.04.2019
4. System overview
10. Manifold PCB

Ref: 122010.02EN / Date: 29.09.2018
4. System overview
4.3.5 O2 sensor
The O2 sensor monitors the O2 level in the air between the proportional gas blender and the inspiratory tube
of the manifold, and located in the rear panel of the fabian. It calibrates itself automatically after every restart
and in case of continuous long-term operation daily (~40-45 sec/24h).
The O2 sensor built up from the O2 cell and the calibration adapter. The exchange of the O2 cell is part of the
yearly maintenance (check warranty period). The replacement of the cell might be needed more frequently
(for example: high pressure occurred on the cell).
11. Main components of the O2 sensor (upper) and O2 sensor tubing (lower)

Ref: 122010.02EN / Date: 24.04.2019
4. System overview
Numbers in Component name Comment

picture 11.
1 O2 cell
2 Calibration adapter
3 Connection with mainboard
4 Tube connection with calibration gas (output of the Tube W
blender)
5 Tube connection with mixed patient gas (output of the Tube R
blender)
6 Tube connection with inspiratory tube port of the Tube R
manifold

Ref: 122010.02EN / Date: 29.09.2018
4. System overview
4.3.6 Proportional gas blender
The complete blender is built up from the following components:

- Blender PCB
- Input block (Input pressure regulator block)
- Proportional block (Calibration valve block)
- Flow sensor block
12. Main components of the O2 sensor (upper) and O2 sensor tubing (lower)
13. Main components of Proportional gas blender

Ref: 122010.02EN / Date: 24.04.2019
4. System overview
The above mentioned three blocks (input block, proportional block and flow sensor block) are located under
the Blender PCB, as a complete unit.
The Calibration valves and the Input pressure regulators are easily accessible on the sides of the blocks and
exchangeable.
The Blender contains two pieces 1D (one in the air side and one in the Oxygen side) multiuse flow sensors.
These are accessible after the remove of the Blender PCB. In case of defect or failure of the Blender flow
sensor never try to clean it, but exchange the sensor or the complete Blender. Do not touch the pins of the
flow sensor.
14. Position of the flow sensors in the Proportional gas blender (Blender PCB is dismounted)

Ref: 122010.02EN / Date: 29.09.2018
4. System overview
Numbers in pictures
12, 13 and 14, or Component Comment
name on the
Blender PCB
1 Gas inlet O2
2 Gas inlet Air
3 Pressure regulators
4 Calibration valves
5 Pressure sensors
6 Proportional valves
7 Pneumatic Pressure relief Valve nCPAP, approximately. 450 - 600 mbar

8 Mixed Patient gas Connection to O2 Sensor
9 Outlet to pressure sensor prox. Purge flow
10 Calibration gas Connection to O2 sensor
11 Inner flow sensors
D203 If ON, 24VDC for the blender is okay
Receiving new data

Blinking
D400
There was a problem of automatic
Blinking very fast
blender calibration
D401 If ON, 3.3VDC for the blender is okay
P404 Potentiometer 21% O2 valve/ Flow sensor calibration

(clockwise +, anticlockwise -)
P403 Potentiometer 100% O2 valve/ Flow sensor calibration

(clockwise +, anticlockwise -)

Ref: 122010.02EN / Date: 24.04.2019
4. System overview
4.4 Internal tubing
Colour code of the tubing is the following (See in picture 14.)

RED Mixed gas to patient
BLUE Purge flow
YELLOW Proximal pressure sensor
GREEN Inspiratory pressure sensor
WHITE Calibration gas
GREY Oxygen
BLACK Air
15. Tube connection between the Manifold, Proportional gas blender and O2 sensor

Ref: 122010.02EN / Date: 29.09.2018
4. System overview
16. Inner tubing of the Proportional gas blender (The color code does not match with the above
mentioned)
(Mixed Patient gas connector to O2 Sensor [number 8 in the table above] is not signed on the picture)

Ref: 122010.02EN / Date: 24.04.2019
4. System overview
4.5 PDMS/ Network/ acuLink connection

License for acuLink (our so called PDMS interface) is needed for the fabian devices, the license to activate this
functionality can be ordered through Acutronic Medical Systems AG.
Acutronic Medical Systems AG support acuLink with 5 different protocols:

1. Acutronic RS232 protocol without wave data
2. Acutronic RS232 protocol with wave data
3. Acutronic RJ45 protocol without wave data (HL7 conform)
4. Acutronic RJ45 protocol with wave data (HL7 conform)
5. IVOI protocol from Philips for Intellibridge/Vuelink
There are several drivers on the market available, which supports our acuLink protocol. For the drivers itself
the manufacturer are responsible and have documentation on the supported versions.
Via the GUI in the Service Mode – Network menu you can check the type of the PDMS protocol and interface,
and the network settings.
If necessary contact Acutronic Medical Systems AG via GMB-CH-AMS-Support@vyaire.com or manufacturer

of the drivers.

Ref: 122010.02EN / Date: 29.09.2018
5. Failure analysis
5 Failure analysis
5.1 Alarms messages on device
Below listed the most relevant alarms with main priority class I.
In case of this type of alarms corresponding messages are blinking on the display, highlighted red and beep
sounds. (If system failure occurs, a yellow triangle also blinking on the display.)
This table is intended to help you determine and resolve the cause of an alarm message. For more
information, please refer the IfU.
The log file contains the message text of the occurred fault.
An alarm with higher sub priority can hide a lower sub priority alarm. Alarms are categorized into 9 sub
priority levels; 1 is the highest, 9 is the lowest sub priority level.
Sub
Alarm text Alarm Type Possible cause Solution
priority
-Fan is not moving 1
- Fan rotation
Cooling fan defect System failure Clean/replace cooling fan
value is out of
tolerance
- Controller PIC is 1
out of order
- One of the
connections - NetDCU check
COM interface System failure between NetDCU
and Controller PIC - Mainboard check
is failed
- The multiplexer is
failed
1
Internal - NetDCU check
DIO interface System failure
communication
- Mainboard check
- Shortcut on 1
Power PCB
- NetDCU check
I2C interface System failure - Port expander
failure - Mainboard check
- Shortcut on I2C
1
Internal - NetDCU check
parallel interface/PIF System failure
communication
- Mainboard check
- Monitor PIC is out 1
of order
- One of the
- NetDCU check
SPI interface System failure connections
between NetDCU - Mainboard check
and Monitor PIC is
failed.
checksum 2
System failure - Reinstall controller PIC SW
conductor/controller

Ref: 122010.02EN / Date: 24.04.2019
5. Failure analysis
Sub
Alarm text Alarm Type Possible cause Solution
priority
PIC - Communication check
2
checksum monitor - Reinstall monitor PIC SW
System failure
PIC
- Communication check
Low physical 2
memory - please System failure HW malfunction NetDCU check
reboot!
- Safety relay 2
Check optically the 2 safety
failure
relays on the Mainboard ->
Safety relay defect System failure - Soldering
Exchange safety relay or
material across the
Mainboard
safety relay
Either one of the 2
watchdogs are
failed or one of the - Power board check
Voltage monitoring System failure
measured voltage - Mainboard check
values are out of
tolerance.
No power or too 2
less power from
battery.
-Fuse might be Exchange battery, check
Battery defect Electrical power
blown fuse.
- Battery failure
- Connector to the
battery is failed
Exchange exhalation 2
Exhalation Exhalation
System alarms membrane holder or
calibration calibration failed
membrane.
Proportional gas 2
check Blender System alarms blender or control Check blender
failure
O2 sensor calibration Error occurred 4
Sensor alarms Repeat calibration.
failed during calibration.
Oxygen sensor defect Sensor alarms O2 sensor failure Replace O2 sensor. 4
Replace O2 sensor as soon 4

Oxygen sensor used
Sensor alarms O2 sensor worn. as possible.
up
Calibration still available.
4
O2 sensor or mixer
O2 value out of range Sensor alarms Replace O2 sensor
failure

Ref: 122010.02EN / Date: 29.09.2018
5. Failure analysis
5.2 Power PCB - status LEDs and fuses
17. Power PCB status LEDs and fuses
1 LED 1 “Power OFF” LED

2 LED 2 ON 5V OK
3 LED 3 ON 12 V OK
4 Flashes Power board in normal condition
LED 4
OFF Accu PIC error
5 LED 5 OFF Unit in Battery mode
Flashes (quickly) Battery failure / Battery disconnected
State of Flashes (1 / sec) Charging
charge Flashes (1 / 10 sec) Battery full / Unit in mains operation
6 Safety OFF function
F3 (Fuse type: SMD, 3 AT, 125 V” MELF 6125” 6.1mm
x 2.7mm)
7 24V connection
F2 (Fuse type SMD, 3 AT, 125 V” MELF 6125” 6.1mm
x 2.7mm)

Ref: 122010.02EN / Date: 24.04.2019
5. Failure analysis
5.3 Mainboard - watchdog LEDs

A watchdog circuit monitors the processors of the device.
The LED lights up when the processor is ok.
18. Indicator watchdog LEDs on the Mainboard
The numbering of watchdog LEDs depends on the hardware version, it is D700-703 or D600-603.
D700 Controller PIC

D701 Monitor PIC
D702 NetDCU
D703 Alarm PIC
D600 Controller PIC

D601 Monitor PIC
D602 NetDCU
D603 Alarm PIC

Ref: 122010.02EN / Date: 29.09.2018
5. Failure analysis
5.4 Software watchdog

Error code HW line* Indicator LEDs (see on Meaning Possible cause
(Message on the picture 27) and its state
GUI**)
WDST#0 - - - Collective WDST ***
WDST#4 WDST_0 D602/D702 1011 NetDCU/GUI failure - GUI SW
WDST#8 - - 1111 All WDST’s OK - Mainboard HW
and voltages 5V or - Accu-PCB HW
24V out of range
WDST#16 WDST_1 D600/D700 1110 Controller PIC failure - PIC SW
WDST#32 WDST_2 D601/D701 1101 Monitor PIC failure - Mainboard HW
WDST#64 WDST_3 D603/D703 0111 Alarm PIC failure - Multiplexer HW
*previous documents may refer HW line as error code

** if there is not any other same or higher priority alarm at the same/earlier time
*** appears, following the failure of any of the WDST’s, as soon as the failure disappears
5.5 Alarm messages about the Proportional Gas Blender

In case of blender alarm corresponding messages are displayed and beep sounds. The most important
alarms and possible fault causes are specified in the following list.
The log file contains the error code and the message text of the occurred fault.
Error
Message Possible Cause
Code
0 Connection Problem - Connection cable Blender / Mainboard
1 AIR control - Proportional valve

- Pressure sensor
- Blender PCB
2 O2 control - Blender flow sensor
- Pressure regulator
3 Override Voltage Proportional valve - 24 Volt fail (PIN 7,8,9)
Communication between blender / - Blender PCB

4 Mainboard - Mainboard
- Connection cable
- Contact problem
Hot wire Air AIR: U101, L100, R117, 118, T101, R113
8
(See picture 18. below.)
- Blender Flow sensor

Ref: 122010.02EN / Date: 24.04.2019
5. Failure analysis
- Contact problem
Hot wire O2 O2: U101, L101, R119, 120, T102, R114
16
(See picture 18. below.)
- Contact problem, U101, L100, L101

24 Hot wire Air AND O2 (See picture 18. below.)
FRAM / Memory check - Try to load new Software

32
- Blender PCB
Zero calibration - Proportional Valve (Leak)

64
128 / FRAM - Blender PCB
160
19. Part of Blender PCB (Left side is the O2 side, Right side is the Air side)

Ref: 122010.02EN / Date: 29.09.2018
5. Failure analysis
5.6 Trends, Log files, Device info

To read out the trends, log files and device info, use a standard (Windows CE compatible) USB stick and
attach it to the fabian via the rear panel and follow the next steps:
Press (“Menu/ Calibration” button) two times to access the Menu.
20. Menu
Press “Tools” button to save the Trends, Log files and the Device info.

Ref: 122010.02EN / Date: 24.04.2019
5. Failure analysis
21. File saving process
The “save” buttons are displayed once the USB key is recognised. Then push the appropriate button(s) and
follow the instructions.
22. Follow the instruction
Push the “Yes” button and do not disconnect the USB stick while saving the data.

Ref: 122010.02EN / Date: 29.09.2018
5. Failure analysis
23. File saving is might take a few moments
In case of bigger files you may have to wait a few moments.

When the save process is completed, there will be no new message displayed on the screen.
If you also save the Trends, the Log files and the Device info, you will find 3 new folders on the USB stick. The
name of the folders are the concatenation of the Device-ID and the type of the file.
24. Log files and Trends in folders, Device info in a text document
The Device Info contains the following information in a text document:

Ref: 122010.02EN / Date: 24.04.2019
5. Failure analysis
25. Device info
26. Logs contain the data from the SD Card and FFDISK (Both are on the NetDCU)

Ref: 122010.02EN / Date: 29.09.2018
5. Failure analysis
27. Log files in text documents (upper), Trends in Excel Sheets(lower)

Ref: 122010.02EN / Date: 24.04.2019
6. Calibration and Service information
6 Calibration and Service information

On the homepage you can find the Calibration and Test Instruction, and the Test protocol documents for the
device. After registration you can download the appropriate version from the Acutronic Medical Systems AG
website.
https://www.acutronic-medical.ch/client-area/welcome.html > Downloads and Media > Neonatology >

Current Devices > fabian +nCPAP evolution > Technical Information > Software & Firmware
Download the corresponding software package and use the documents from 06 Actual Test Instruction
folder.
28. Use the documents from the 06 Actual Test Instruction folder

Ref: 122010.02EN / Date: 29.09.2018
6.1 System and service information

In order to gain system and service information and start the calibration press (“Menu/Calibration”
button) two times.
29. Menu
Press “Info” button to check the System Information.
30. System Information
The Service-password is given by the last 5 digits of Device-ID. (For example on the picture above the Service-
password is E8A90). The Device-ID is stored in the memory of the NetDCU (Chapter 3.2.2.).
Go back to the Menu and get into the Service mode.
Enter the Service-password of the fabian.

Ref: 122010.02EN / Date: 24.04.2019
31. Enter the service-password
32. Service Mode
In service mode you can check the System information, by pressing the “System” button.

Ref: 122010.02EN / Date: 29.09.2018
33. Service Mode- System Information
Information which cannot be found in Info menu (without service mode) but in Service Mode – System menu
are the following (see pictures 29 and 32.):
- Interfaces
- State Conductor PIC
- PhysMemory
- FFDISK
- Hardware Configuration
In order to check the information of the Power module navigate back to the Service Mode main menu and
choose the Accuboard submenu.
34. Battery information
It is possible to check the actual state and the driver version of the communication protocols in Service
mode -> Interfaces submenu.

Ref: 122010.02EN / Date: 24.04.2019
35. Service information about the Interfaces
If Patient Data Management System (PDMS) is available, it is useful to monitor to following network data.
Network submenu accessible via the Service mode menu.
36. Service information about the Network

Ref: 122010.02EN / Date: 29.09.2018
6.2 Calibration submenu

In order to calibrate the device navigate back to the Service Mode main menu and choose the calibration
submenu.
37. Service Mode- Calibration
Flow correction default setting is 0.960 in both NEO and PED ranges. Modify it only at the instruction of
Acutronic Medical Systems AG.
Always take care of the correct setting of the Altitude.
6.3 Blenderboard submenu
38. Service Mode- Blenderboard

Ref: 122010.02EN / Date: 24.04.2019
6.4 MonitorPIC submenu
39. Service Mode- Monitor PIC
Typical values of P-insp (P-mix), Oxy1, Oxy2, P-AIR and P-OXY see in table below:
P-insp 0mbar 570±10

60mbar 2400±10
Oxy1 Data of Oxygen cell:
Oxy2
522 21Vol% O2 , Sensor new (typical)
435-626 21Vol% O2 , Sensor new (range)
≤ 327 Sensor nearly defect (at 21%)
≤ 246 Sensor defect (at 21%)
≥ 839 Sensor defect (at 21%)
≤ 1561 Sensor nearly defect (at 100%)
≤ 1172 Sensor defect (at 100%)
≥ 4000 Sensor defect (at 100%)
≤ 65 Sensor is disconnected/ cable is broken
P-AIR Dynamic condition 2300±10 (approx. 1.6 bar)
P-OXY
The State Monitor PIC column shows if the events are occurred/ conditions are met.
0 – Inactive
1 – Active

Ref: 122010.02EN / Date: 29.09.2018
6.5 Valves submenu
40. Service Mode- Valves
Perform a “Burn In” after replacing the calibration valves (on the Manifold) for 15minutes. (You can hear the
sound of the valves clacking.) After this period the fit of the sealing rings is okay to close properly the
calibration path.

Ref: 122010.02EN / Date: 24.04.2019
6.6 Display submenu

Display submenu is accessible via the Service mode menu. Besides controlling the brightness the touch
screen calibration can be performed in this submenu as well.
41. Service Mide- Display (Brightness setting is the same as in the user Menu)
During the touch screen calibration process carry out the next steps by following the instructions.

Ref: 122010.02EN / Date: 29.09.2018
42. Touch screen calibration process
After a successful calibration you have to push once on the touchscreen and then the calibration is stored. If
you don’t do it within the 30 seconds, the calibration is not stored and you have to redo it again.

Ref: 122010.02EN / Date: 24.04.2019
6.7 Settings submenu

Settings submenu is accessible via the Service mode menu.
43. Service Mode- Settings
At this submenu it is possible:

- to switch Nursecall ON/OFF
- to set neonatal and paediatric mode ON/OFF
- to load and save User settings
- to enable factory settings
- to switch auto alarm limits ON/OFF
The “reset values” sets the parameters to their default values
The “reset complete” applies the default settings and sets the parameters to their default values.
By “Enable factory settings” it makes “factory defaults” option accessible for the end-user in the general
Ventilation submenu.
44. Factory defaults option is disabled

Ref: 122010.02EN / Date: 29.09.2018
45. “Enable factory settings” makes “factory defaults” option accessible
46. Reset the factory defaults

Ref: 122010.02EN / Date: 24.04.2019
6.8 Licensing submenu and License handling

Licensing submenu is accessible via the Service mode menu.
47. Service Mode- Licensing
Available licenses can be monitored in licensing submenu. The licenses are related to Device-ID, therefore if
the Device-ID is exchanged (for example: in case of the exchange of the NetDCU), all the previous licenses are
lost (contact Acutronic Medical Systems AG).
48. License delete hint
The Licensing is managed by Acutronic Medical Systems AG at factory side. Should it be necessary to re-enter
the keys, please contact Acutronic Medical Systems AG.
After registration you can download the appropriate version of the Demo License Generator from the
Acutronic Medical Systems AG website.

Ref: 122010.02EN / Date: 29.09.2018

Current Devices > fabian +nCPAP evolution > Technical Information > Software & Firmware > Actual Demo
License Generator
The License, which generated with Demo License Generator, is valid for 3 months.
49. Demo License is valid for 3 months

Ref: 122010.02EN / Date: 24.04.2019
50. Follow the instructions to generate demo license
It is possible to set up the license keys via the update USB stick also. The license key (available from
Acutronic Medical Systems AG) must be located in the SETUP\ LICENSE directory on the USB update stick.
Start fabian in manual update mode:
Set the install type to manual in SETUP\ AcuInstall.ini file (Leave all of the other settings unexchanged).
#### Installtype########################################################################
# define what and how to install (see below)
#
# MANUAL: enables the manual installation, does not read the [CONFIGURATION]
# AUTO: installs the update using the current configuration of NetDCU,
# does not read the [CONFIGURATION]
# COLDBOOT: for production or a complete first installation
#########################################################################################
INSTALLTYPE=MANUAL
During the manual installing process on the fabian press “Licensing” button, then “install license from USB”
(Modul Licensing or PDMS Licensing) button and follow the instructions.

Ref: 122010.02EN / Date: 29.09.2018
6.9 Maintenance submenu

Maintenance submenu accessible via the Service mode menu.
51. Maintenance options in Service Mode
If you switch off the service-password during the service or repair process, please do not forget to switch it on
after the maintenance.
It is possible to switch off the system alarm (this is the same function as in Chapter 7.4. mentioned) with
usage of the System Alarms slidebar.
If you exchanged the main-PCB, you have to set the running hours of the device here in manually.

Ref: 122010.02EN / Date: 24.04.2019
52. Set operating times after maintenance/ repair
When you put in a “Next service date” the user will have the following information in the info-bar visible:
This has no impact to the functionality of the device. It shows only, that the next maintenance has to be
done.

Ref: 122010.02EN / Date: 29.09.2018
7. Software update
7 Software update
For Software update instructions please read the Update description. After registration you can download
the appropriate version of the needed documents from the ACUTRONIC Medical Systems AG website.

Current Devices > fabian +nCPAP evolution > Technical Information > Software & Firmware
53. Use the documents from the 04 Update description folder
After software update fill the Software update form out and send it back to ACUTRONIC Medical Systems AG.

Ref: 122010.02EN / Date: 24.04.2019
8. Servicing
8 Servicing
8.1 Cleaning and disinfection
Clean and disinfect the house and the screen of the fabian with a damp cloth at regular intervals. To clean
the system we recommend mild soap-suds. While cleaning and disinfecting the fabian disconnect the unit
from mains supply. Hold the device horizontally and make sure that no fluids penetrate in the device. For
disinfection refer to your infection control or housekeeping protocol that references how to disinfect
equipment of this nature. If you disinfect the device by spraying, make sure not spray in the system openings.
Cleaning and disinfection procedures according to country specific regulations. The device may not be
sterilized under any circumstances.
Cleaning of the Flow Sensor and the Membrane holder with membrane according to the IfU Sterilisation /
Cleaning / Disinfection (Chapter 15.). Preparation of the test sets, maintenance kit and spare parts according
to the manufacturer information.
8.2 Transportation
Only original packaging ensures optimal protection of the equipment during transport. If it is necessary to
return the equipment during the warranty period, the manufacturer is not liable for damages caused by
incorrect packaging.
The tolerable ambient conditions during transport see in Chapter 10.1.
8.3 List of the test equipment and special tools

- PH1 screwdriver
- PH2 screwdriver
- Allen key 2,5
- Forceps
- Pliers
- Assembly key for binder connector (See: spare parts list)
- Socket key 6p 12
- Test-Set non intubated modes (See spare parts list)
- USB stick
- Test lung
- ESD set
In case of Software update:

- PIC Programmer ICP2-p (See spare parts list)

Ref: 122010.02EN / Date: 29.09.2018
8. Servicing
8.4 Alarms off

During repair and troubleshooting it is possible to disabled the system and patient alarms. Simultaneously
press (home) and (mute alarm) buttons, hold for approx. 5 sec. In the upper right corner the
symbol of “sys alarms off” will appear. From now all alarms are disabled till you hold for approx. 5 sec
(home) and (mute alarm) simultaneously again or restart the unit.
8.5 Service-Password off

Menu > Service Mode > Maintenance > Service-Password
If you switch off the service-password during the service or repair process, please do not forget to switch it on
after the maintenance.
See Chapter 5.9.
8.6 Spare parts list

See “Spare Part List” on the ACUTRONIC Medical Systems AG website:

Current Devices > fabian +nCPAP evolution > Technical Information > Spare Parts Catalogue
8.7 Handling of the used components

The used, non-repairable, exchanged components please send back to the ACUTRONIC Medical Systems
AG.
Return of spare parts: ACUTRONIC Medical Systems AG

Fabrik im Schiffli
8816 Hirzel / Switzerland
Treat the electrical and electronic waste in accordance with the local recycling and waste management
regulations.

Ref: 122010.02EN / Date: 24.04.2019
9. Repair and various replacements/ Disassembly and assembly
9 Repair and various replacements/ Disassembly

and assembly
Before disassembling the fabian, the system must be checked to isolate the part to be exchanged. The
necessary steps to disassemble the complete unit, all its subsystems and spare parts are detailed in the
following description. Steps that are not necessary can be skipped.
54. Flowchart of the disassembling process (Accessable components are in the ovals)

Ref: 122010.02EN / Date: 29.09.2018
9.1.1.1 O2 sensor cell exchange
To replace the cell of the O2 sensor, the removal of the housing is not necessary. Screw the 2 knurled head
screws out from the O2 sensor module (rear panel of the fabian) and take the sensor out.
55. O2 sensor fixing screws
Slightly push backwards the pawl on the connector and disconnect it from the cell. Screw out the cell from
the calibration adapter.
56. O2 cell removal
After the exchange of the cell reconnect the cable and fasten the sensor module with screws.

Ref: 122010.02EN / Date: 24.04.2019
9.1.1.2 Expiratory membrane exchange
The exchange of the Expiratory membrane is part of the yearly maintenance.

To replace the Expiratory membrane, the removal of the housing is not necessary. Turn the Expiratory tube
port clockwise and pull it out. With the help of a forceps replace the membrane.
57. Expiratory membrane in the Expiratory tube port
Take care on the direction of the membrane, the TOP sign have to be on the upper side.
58. TOP sign on the upper side of the Expiratory membrane
After the replacement of the Expiratory membrane, screw the Expiratory tube port back.

Ref: 122010.02EN / Date: 29.09.2018
9.1.1.3 Proximal connector
To replace the Proximal connector, the removal of the housing is not needed. In case of its damage, screw
the connector out and replace it.
59. Proximal connector on the Manifold
9.1.1.4 User knob
To replace the User knob, the removal of the housing is not necessary. In case of its damage, pull the knob
out and replace it.
60. User knob

Ref: 122010.02EN / Date: 24.04.2019
61. Placement of the User knob on the Plastic front panel (Contact with the Encoder)
9.2 Housing removal

Disconnect the fabian from the mains and put it on a soft antistatic mat.
Screw off the 4 black rubber feet, and the 2 screws on the back side of the fabian. The whole housing is
already removable in one piece, by its backwards pulling.
62. Steps of the Housing removal
Remove the 4 screws from the front part of the module, loosen the remaining 2 on the back part and bend
the Power. module backwards (>90°).
63. Remove the 6 screws on the 2 sides of the fabian

Ref: 122010.02EN / Date: 29.09.2018
The following components are accessible after the opening of the upper side of the fabian:
- Power module (Power PCB, Power supply “XP”, Powerpack/ Internal battery)
- Mainboard
- NetDCU
- Connector PCB
- Power inlet module
64. Accessible components
After the reparation, fasten the Power module and the housing with screws in its original position.
9.2.1.1 Internal battery (Powerpack/ Batterypack) exchange
To access the Powerpack please read first the disassembling instructions above in Chapter 8.2.

Ref: 122010.02EN / Date: 24.04.2019
65. Powerpack/Batterypack fixing
Disconnect the AKKU cable, which provide contact between the Power PCB and the Powerpack. After the
removal of the 3 fastening screws the metal plate can be slided away and the Powerpack/ Betterypack is
already accessible. During the exchange of Powerpack/ Betterypack handle the anti-skidding foil with care.
66. Components
Exchange the Powerpack (take care of the disposition of the cable on the Powerpack/ Betterypack), slide
back the metal plate and fix it with 3 screws. Connect the new Powerpack/ Betterypack with the Power PCB.
Under normal the battery has no wear and tear. The internal battery is part of the 4-year maintenance kit and
will be replaced in this time frame.
Check the capacity of the battery yearly.
A fully charged battery must have an operating time of 2 hours (IPPV-Mode with standard paediatric settings
and connected to the gas supply).
If the capacity is lower, the internal battery must be exchanged.

Ref: 122010.02EN / Date: 29.09.2018
9.2.1.2 Power PCB
To access the PowerPCB please read first the disassembling instructions above in Chapter 8.2.
67. Connection and fixing of Power PCB
Disconnect the following cables:

- Ribbon cable between the Power PCB and the mainboard (take care of the strap on the connector)
- AKKU cable, which provide contact between the Power PCB and the Powerpack
- +/- 24V which comes from the Power supply “XP” board (with the help of a forceps move backwards
the pawls on the connector on the Power supply “XP” board)
- EXT +/- which comes from the Connector PCB. (Be careful with the usage of plier) (The red cable
connects to the “+” pin and the black one to the “-”.)
Remove the 6 screws and the Power PCB is already detachable.
After the repair or exchange of the board fasten it with screws and reconnect all of the above mentioned
cables. (Some version contains 6 plastic fixing cover on the metal legs between the PCB and the metal plate.
These can deform if the screws are fastened too tightly.)

Ref: 122010.02EN / Date: 24.04.2019
9.2.1.3 Power supply “XP”
To access the Power supply “XP” please read first the disassembling instructions above in Chapter 8.2.
68. Power supply “XP”

- +/- 24V (with the help of a forceps move backwards the pawls on the connector)
- Cable of the ground potential (back panel of the housing)
- Power supply inlet cable (with the help of a forceps move backwards the pawls on the connector)
Remove the 4 screws and the Power supply “XP” is already detachable.
After the repair or exchange of the board fasten it with screws and reconnect all of the above
mentioned cables.

Ref: 122010.02EN / Date: 29.09.2018
9.2.1.4 Connector board
To access the Connector board please read first the disassembling instructions above in Chapter 8.2.
69. Disposition of the Connector board

- EXT +/-, which connects with the Power PCB (Be careful with the usage of plier) (The red cable
connects to the “+” pin and the black one to the “-”.)
- Nurse call connector on the mainboard
- Flow sensor connector on the mainboard
With the help of Assembly key for binder connector (see spare parts list) the 3 screws, which fasten the
Connector board, are removable. (During the remove take care of the O2 sensor connector.)
70. In-/Outlets of the Connector board on the rear panel
cables. During the assembling do not forget to put the securecap of the VDC connector back.

Ref: 122010.02EN / Date: 24.04.2019
9.2.1.5 NetDCU
To access the NetDCU please read first the disassembling instructions above in Chapter 8.2.
Remove the 3 fixing screws and slightly pull up the NetDCU (The NetDCU connects to the Mainboard with pin
straps). Please take care to keep the NetDCU parallel with the Mainboard during the removal, otherwise the
pins may be deformed. The connectors are SMD soldered and do easy brake off and this is not covered by
the warranty.
The position of the pin straps and place of the screws on the Mainboard see below.
71. Pins on the Mainboard and connectors on the lower side of the NetDCU
After the repair or exchange of the board fasten it with the pin connectors and the screws.

Ref: 122010.02EN / Date: 29.09.2018
9.2.1.6 Mainboard
To access the Mainboard please read first the disassembling instructions above in Chapter 8.2.

- Power supply (take care of the strap on the connector)
Front side:
- Keyboard
- UDP (User Knob Plastic)
- Touch (Pull up very slightly the black strap to disconnect the cable)
- Manifold (take care of the strap on the connector)
- Blender (take care of the strap on the connector)
- Fan
- Loudspeaker
- Backlight
- LCD display (Pull up slightly the black strap to disconnect the cable)
Back side:
- O2 sensor
- Nurse call
- Flow sensor
Remove the 6 fixing screws and slide forwards the mainboard.

Ref: 122010.02EN / Date: 24.04.2019
72. Connection and fixing of the Mainboard
(If there is not enough space to remove the Mainboard, first screw out the remaining 2 screws, which are
fasten the Power module.)
cables. During the replacement, suggested to fit first the 3 connectors (RS232, USB, Ethernet) into the holes
on the rear panel. Please take care to keep the O2 sensor cable in the notch, otherwise the cable may be
damaged. Please take care to keep the O2 sensor cable without tangle, otherwise next time the O2 cell may
not be exchangeable without the removal of the housing.
73. Mainboard connectors go through the rear panel

Ref: 122010.02EN / Date: 29.09.2018
9.2.1.7 Power inlet module
To access the Power inlet module please read first the disassembling instructions above in Chapter 8.2.
Remove the Mains cable lock and the 2 fixing screws (back side of the rear panel).

- Cable of the ground potential (back panel of the housing)
- Power supply “XP” - Power inlet module cable (with the help of a forceps move backwards the pawls
on the connector)
74. Connection and fixing of the Power inlet module
After the repair or exchange of the module fasten it with screws and reconnect all of the above mentioned
cables. During the assembling do not forget to put the Mains cable lock back.

Ref: 122010.02EN / Date: 24.04.2019
9.2.2 Remove the Loudspeaker and Fan module
To access the Loudspeaker and Fan module please read first the disassembling instructions above in
Chapter 8.2.
Disconnect the cables of the Fan and the Loudspeaker on the mainboard. (Both of them.)
Close back the Power module and fix it with screws.
Turn the whole fabian upside down.
75. Bottom side of the fabian without housing
Remove the 4 screws and pull out the Loudspeaker and Fan module.
76. Remove the 4 screws on the 2 side of the fabian

Ref: 122010.02EN / Date: 29.09.2018

Ref: 122010.02EN / Date: 24.04.2019
77. Disassembled Loudspeaker and Fan module
The following components are accessible after the removal of the Loudspeaker and Fan module:
- Manifold
- Proportional Gas Blender
- Loudspeaker
- Fan
- O2 sensor (with calibration adapter)
After the reparation fasten the Loudspeaker and Fan module in original position with screws.
9.2.2.1 Manifold
To access the Manifold please read first the disassembling instructions above in Chapter 8.2.2.
Disconnect the following tubes and cables:

- mixed patient gas tube (blue hose comes from the Proportional Gas Blender)
- output tube of the O2sensor (red hose)
- ribbon cable comes from the mainboard

Ref: 122010.02EN / Date: 29.09.2018
78. Plastic front panel loosening
Remove the 2 screws, which fasten the Manifold.
In case of removal of the Manifold, the Complete Front Housing have to be also displaced. Therefore remove
the 2 Front Housing fixing screws, which are closer to the manifold and loose the other 2, which are farther
from the manifold. Bend the Complete Housing Front panel a little bit forwards (~20°). Do not open in too big
angle, because the Touch cable may come out from the Mainboard connector.
79. Manifold removal
Slide the Manifold out.

Ref: 122010.02EN / Date: 24.04.2019
80. Lay the Manifold on the metal bulges and connect the appropriate tubes and cables
After repair or exchange of the Manifold slide it back under the front panel. To find the right position the
metal bulges help. Fasten it with 2 screws. Close back the Complete Front Panel and fix the 4 screws.
Connect all of the above mentioned tubes and cables.
9.2.2.2 Proportional Gas Blender
To access the Proportional Gas Blender please read first the disassembling instructions above in Chapter
8.2.2.
Disconnect the following cables and tubes:

- O2 input tube (grey) (Suggested to remove from the blender by pushing down the blue edge of the
connector)
- Air input tube (black) (Suggested to remove from the blender by pushing down the blue edge of the
connector)
- Mixed patient gas tube to the O2 sensor (red) (Suggested to remove from the O2 sensor by pushing
down the blue edge of the connector)
- Outlet tube to pressure sensor proximal/ purge flow (blue) (Suggested to remove from the Manifold)
- Calibration gas tube, connection to O2 Sensor (white) (Suggested to remove from the O2 sensor)
- Mainboard ribbon cable

Ref: 122010.02EN / Date: 29.09.2018
81. 5 tubes and 1 cable connection of the Blender
Screw out the 3 fixing screws and remove the Proportional Gas Blender.
82. 3 fixing screws of the Blender
If you detect failure related to one of the component of the Proportional gas blender, please contact service/
local dealer, and clarify if under the specific circumstances the Proportional gas blender is exchangeable
partially or in a whole block.
9.2.2.2.1 Proportional valves
To access the Proportional valves please read first the disassembling instructions above in Chapter 8.2.2.2.
Disconnect the cable of the appropriate valve from the Blender PCB, by pressing slightly down the edge of
the connector. (Both of cables, if you have to replace both of the valves.)
Ref: 122010.02EN / Date: 24.04.2019
83. Connectors of the 2 Proportional valves
Remove the 2 screws where the Proportional valve is fixed (on the side of the Blender) and pull out it from
the Blender.
84. 2 fixing screws of the Proportional valve on the side of the Blender
After the exchange of the valve(s), push it back into the blender, fasten it with screws and reconnect its
cable(s).
9.2.2.2.2 Calibration valves
To access the Calibration valves please read first the disassembling instructions above in Chapter 8.2.2.2.
Disconnect the cable of the appropriate valve from the Blender PCB. (Both of the cables, if you have to
replace both of the valves.)
Perform a “Burn In” after replacing the Calibration valves for 15minutes (Please see Chapter 5.5).

Ref: 122010.02EN / Date: 29.09.2018
85. Connectors of the 2 Calibration valves
Remove the 2 screws where the Calibration valve is fixed (on the side of the Blender) and carefully remove
the valve, with taking care all of its moving parts.
86. 2 fixing screws of the Calibration valve on the side of the Blender
After the exchange of the valve(s), put it back into the blender, fasten it with screws and reconnect its
cable(s).
9.2.2.2.3 Input pressure regulators
To access the Input pressure regulators please read first the disassembling instructions above in Chapter
8.2.2.2.
Remove the 2 screws where the Input pressure regulator is fixed (on the side of the Blender)
Ref: 122010.02EN / Date: 24.04.2019

Ref: 122010.02EN / Date: 29.09.2018
87. 2 fixing screws of the Input pressure regulator on the side of the Blender
After the exchange of the Input pressure regulator, put it in right position and fasten with the screws.
9.2.2.2.4 Blender PCB
To access the Blender PCB please read first the disassembling instructions above in Chapter 8.2.2.2.
Disconnect the following cables and tubes:

- 2 cables of the 2 Proportional valves
- 2 cables of the 2 Calibration valves
- O2 tube goes to the pressure sensor (by pressing the blue edge of the connector)
- Air tube goes to the pressure sensor (by pressing the blue edge of the connector)
- (The inner flow sensors connections will be dissolved by itself during the removal of the PCB)
Remove the 4 fixing screws and pull up the Blender PCB. The Inner flow sensor still connects to the PCB with
pins (on the bottom side of the board) therefore handle it with more care during the removal.
88. Proportional gas blender module with and without Blender PCB
After the repair or exchange of the Blender PCB, put it in right position and fasten with the screws. Connect
all of the above mentioned cables and tubes.

Ref: 122010.02EN / Date: 24.04.2019

Ref: 122010.02EN / Date: 29.09.2018
9.2.2.2.4.1 Inner flow sensors
To access the Inner flow sensors please read first the disassembling instructions above in Chapter 8.2.2.2.4.
After the removal of the Blender PCB the Inner flow sensors are already accessible.
Screw out the 2 screws and remove the flow sensors with the help of a forceps.
89. Position of the inner flow sensor in the Blender
Before inserting the new flow sensor read carefully the handling instructions of the manufacturer. Use
forceps and do not touch the pins of the sensor.
After the replacement fasten the inner flow sensors with the metal plate and screws.
9.2.2.3 Loudspeaker
To access the Loudspeaker please read first the disassembling instructions above in Chapter 8.2.2.
90. Loudspeaker disassembling
Separate the wires of the Loudspeaker from the wires of the Fan. Remove the 4 screws and take the
Loudspeaker out.

Ref: 122010.02EN / Date: 24.04.2019
After repair or exchange of the Loudspeaker fasten it with the screws and lead the cables through the
wrapping hose.
Lead the cables through the appropriate notch under the Manifold to connect it to the Mainboard (Access
the mainboard: Please read Chapter 8.2.)
91. Loudspeaker and Fan module connection with the Mainboard
9.2.2.4 Fan
To access the Fan please read first the disassembling instructions above in Chapter 8.2.2.
92. Fixation of the Fan with 4 rubber feet

Ref: 122010.02EN / Date: 29.09.2018
Separate the wires of the Fan from the wires of the Loudspeaker. Turn the 4 rubber feet of the Fan into the
bigger holes and remove the Fan from the metal plate.
After repair or exchange of the Fan fasten it with its rubber feet and lead the cables through the wrapping
hose.
Lead the cables through the appropriate notch under the Manifold to connect it to the Mainboard (Access
the mainboard: Please read Chapter 8.2.)
93. Loudspeaker and Fan module connection with the Mainboard
9.2.2.5 O2 sensor
To access the O2 sensor please read first the disassembling instructions above in Chapter 8.2.2.
Disconnect the following tubes:

- Calibration gas output of the blender (white)
- Mixed patient gas output of the blender, by pressing down the blue edge of the connector (red)
- Mixed gas output of the O2 sensor to the inspiratory port, by pressing down the blue edge of the
connector (red)

Ref: 122010.02EN / Date: 24.04.2019
94. Tubing of the O2 sensor
Remove the 2 knurled head screws from the outside part of the rear panel and pull out O2 sensor.
95. Screws, which fasten the O2 module to the rear panel
Disconnect the O2 sensor-Mainboard cable, by pressing backwards the white pawl with a forceps on the
connector.
To the replacement of the O2 sensor adapter remove the 2 fixing screws and screw off the sensor cell.
96. Screws, which fasten the O2 calibration adapter to the rear metal plate
After the replacement of the O2 sensor connect the O2 sensor-Mainboard cable and fasten the sensor to the
rear panel with 4 screws. Attach all of the above mentioned tubes.
Ref: 122010.02EN / Date: 29.09.2018

Ref: 122010.02EN / Date: 24.04.2019
9.2.3 Complete Front Panel removal

To remove the Complete front panel please read first the disassembling instructions above in Chapter 8.2.
Disconnect the following cables from the Mainboard:

- Keyboard
- UDP (User Knob Plastic)
- Touch (Pull up very slightly the black strap to disconnect the cable)
Remove the 4 fixing screws and take down the Complete Front Panel.
After repair or exchange of the Front Panel fasten it with screws and reconnect all of the above mentioned
cables. Take care of the placement of the cables. Do not forget to wipe the fingerprints and the
contaminations off from the inner side of transparent part of the panel with a dry, clean textile. (Assembling
suggestion: first clean the panel and lead the UDP and Touch wires through the notch and after that the
ribbon cable of the Keyboard. Fit the front panel on the Manifold and cover the fabian with it. Fasten the
Panel with screws. Connect the 3 cables to the Mainboard.)
97. Keyboard (wide green and transparent) and UDP, Touch (2 thinner) cables go through the holes on
the metal front panel
98. Cable of the touch screen connected in the right position (connecting surfaces of the cable look
downwards)

Ref: 122010.02EN / Date: 29.09.2018

Ref: 122010.02EN / Date: 24.04.2019
9.2.3.1 LCD Display
To access the LCD display please read first the disassembling instructions above in Chapter 8.2.3.
99. LCD display without the plastic front panel
Disconnect the following cables from the Mainboard (To access the Mainboard remove the 4 screws close to
the front side, loosen the 2 close to the back side and bend the power module up).
100. Both sides remove the circled 2 screws and loosen the dashed circled screw, to access 2 of
the fixing screws of the LCD display
- LCD Display (Pull up slightly the black strap to disconnect the cable)
- Backlight
Remove 2 LCD screen fixing screws.

Ref: 122010.02EN / Date: 29.09.2018
101. Connection and 2 of the fixing screws of the LCD display
Remove the Loudspeaker and Fan module according to the instructions in Chapter 8.2.2.
Remove the remaining 2 screws.
102. Remaining 2 fixing screws f the LCD display.
After the reparation or during the replacement of the LCD display first lead the LCD display and the backlight
cables through the appropriate notches. Do not twist the LCD display ribbon cable.

Ref: 122010.02EN / Date: 24.04.2019
103. LCD display (white) and Backlight (black and red) cables of the LCD through the holes on the
metal front panel
During the fitting of the LCD Display take care of the direction. (Thicker frame have to be closer to the
Manifold, thinner farther.)
104. LCD display without plastic front panel

Ref: 122010.02EN / Date: 29.09.2018
105. LCD display cable in the right position
Fasten the LCD Display with the 4 screws and connect the LCD display and backlight cables to the
Mainboard. Do not forget to wipe the fingerprints and the contaminations off from the LCD display with a dry,
clean textile. (And fix the Power module with 6 screws.)
9.2.3.2 Encoder
To access the Encoder please read first the disassembling instructions above in Chapter 8.2.3.
106. Removed User knob and the connector of the Encoder
Screw out the fixing screw from the outer side of the Plastic front panel and remove the Encoder.
107. Fixing screw of the Encoder

Ref: 122010.02EN / Date: 24.04.2019
108. Removed Encoder
After the repair fix the encoder in its original position with the screw. Take care of the direction of its cable.
Push the User knob back.
109. Ribbon cable of the Encoder goes upwards to the direction of the Mainboard

Ref: 122010.02EN / Date: 29.09.2018
9.3 Device check

After every repair, maintenance and spare part replacement is a complete device calibration and test
according to the test specification required.
In addition a safety test must be performed.
See chapter 6 Calibration and Service information
9.3.1 Battery calibration
Whenever the Power-PCB is replaced, a SW update is performed or the battery

pack is replaced, a battery calibration must be performed.
1. Fully charge the battery

- Connect the mains voltage until the battery charge indicator shows 100%
2. Battery completely discharge

- Disconnect the main voltage and let the device run in battery mode until it switches itself off.
3. Fully charge the battery

- Connect the mains voltage until the battery charge indicator shows again 100%
4. Battery calibration complete

Ref: 122010.02EN / Date: 24.04.2019
10. Technical Specifications
10 Technical Specifications
See “Technical Data Sheet” on the ACUTRONIC Medical Systems AG website:

Current Devices > fabian +nCPAP evolution > Technical Information > Technical Data Sheet
10.1 Ambient Conditions

During operation During storage and transport
Temperature 10 - 40°C (50 – 104 °F) -20 - 60°C (-4 – 140 °F)
Air pressure 700 - 1060 hPa 500 - 1060 hPa
Relative humidity 10 – 90 %, non-condensing 10 – 95 %, non-condensing
The minimum and maximum ambient temperatures in the clinical area will not affect the accuracy of the
flow, pressure or oxygen measurement.
10.2 Dimensions / Weight

WxHxD 24 cm x 27 cm x 35 cm
Weight Approx. 10 kg
10.3 Ratings
Pressurised air supply 2.0-6.5 bar / max. 40 l/min. Connector: NIST
Medical Grade AIR
Oxygen supply 2.0-6.5 bar / max. 40 l/min. Connector: NIST
100-240 VAC, 0.8 – 0.2 A, 50/60Hz
Power supply external 12 - 24 VDC 4 A
(Charging only when more than 12.5V)
max. 70 W
Power consumption
Standby, connected to mains: 35 W (battery charging)
Internal Battery 13.2 V / 4500 mAh max. charging time: 5 hours
Fuse 3 AT, internal NiMH Battery
battery charge is continuously monitored
battery life approx. 3 hours in conventional mode (IPPV)
Sound pressure Max. 52 dB (A)
Device fuse T1AL
Safety class Type B ≙ EN 60601-1
Certifications of IEC 60601-1, 60601-1-2, 60601-1-8, 6060601-2-12
Classification to EC directive 93/42/EEC Class II b
IP protection IPX1,
Protected against falling water equivalent to 3-5 mm rainfall
per minute for a duration of 10 minutes. Unit is placed in its
normal operating position.

Ref: 122010.02EN / Date: 29.09.2018

Fabian +nCPAP Evolution: Service Manual

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Fabian +nCPAP Evolution: Service Manual

Uploaded by

Copyright:

Available Formats

fabian +nCPAP evolution

fabian +nCPAP evolution | SM-Rev.2.0

Sales and Service Information

Phone: +41 44 729 70 80

2 / 99 fabian +nCPAP evolution | SM-Rev. 2.0

3 Important preliminary remarks .................................................. 8

4 System overview .......................................................................10

5 Failure analysis .........................................................................30

fabian +nCPAP evolution | SM-Rev. 2.0 3 / 99

5.6 Trends, Log files, Device info....................................................................................... 36

6 Calibration and Service information ..........................................41

7 Software update .......................................................................58

9 Repair and various replacements/ Disassembly and assembly ..61

10 Technical Specifications ............................................................99

4 / 99 fabian +nCPAP evolution | SM-Rev. 2.0

1.1 Document Structure

fabian +nCPAP evolution | SM-Rev.2.0

1.2 List of abbreviations

CPAP Continuous Positive Airway Pressure

1.3 Service manual revision history

1.00 • First edition

1.01 • Connection for nurse call

1.07 • New Chapter 10.3 revised

6 / 99 fabian +nCPAP evolution | SM-Rev. 2.0

A: only for internal use

2.2 Hardware Revision History

1.0 • Without external 12 – 24 VDC power capability. Connector is already

3 Important preliminary remarks

3.3 Liability for functionality damages

8 / 99 fabian +nCPAP evolution | SM-Rev. 2.0

3.4 Service, Repair, Maintenance, Calibration & Testing

Use only original Acutronic Medical System AG parts for repair.

fabian +nCPAP evolution | SM-Rev. 2.0 9 / 99

Acutronic fabian +nCPAP medical ventillator

10 / 99 fabian +nCPAP evolution | SM-Rev. 2.0

4.1 Manifold user side

1. Connectors on the Manifold (Photo and cross-section schematic)

1 Inspiratory tube port

3 Proximal pressure measuring tube port

4 Expiration tube port

6 Electronic safety valve coil

7 Safety valve (function: pneumatic pressure relief)

fabian +nCPAP evolution | SM-Rev. 2.0 11 / 99

9 Pressure sensor (P insp)

4.2 Rear panel

2. Connectors on the rear panel (photo and schematic)

1 Mains connection with fuse holder

12 / 99 fabian +nCPAP evolution | SM-Rev. 2.0

9 Connection for compressed air supply 2.0 – 6.5 bar / 40 l/min

4.2.1 External alarm connector (Nurse call)

4.2.2 Connector for 12 - 24 VDC

fabian +nCPAP evolution | SM-Rev. 2.0 13 / 99

4.3 Hardware components

14 / 99 fabian +nCPAP evolution | SM-Rev. 2.0

Marks in pictures Component name Comment

4. Hardware version sign on the Mainboard

fabian +nCPAP evolution | SM-Rev. 2.0 15 / 99

16 / 99 fabian +nCPAP evolution | SM-Rev. 2.0

4.3.3 Power module

fabian +nCPAP evolution | SM-Rev. 2.0 17 / 99

7. Power supply “XP”

18 / 99 fabian +nCPAP evolution | SM-Rev. 2.0