Service Manual FABIAN - 1.1

FABIAN
Service manual
Version 1.1
0124
Manufacturer:
ACUTRONIC Medical Systems AG

Fabrik im Schiffli
8816 Hirzel / Switzerland
Phone: +41 44 729 70 80

Fax: +41 44 729 70 81
E-Mail: [email protected]
www.acutronic-medical.ch
Service Manual FABIAN 1.1
17.12.2005 2/48
PREFACE ...................................................................................................................................4
FOR YOUR OWN AND YOUR PATIENTS SAFETY..............................................................................5
READ INSTRUCTIONS FOR USE ....................................................................................................5
WARNINGS.................................................................................................................................5
ABBREVIATIONS AND SYMBOLS ...................................................................................................6
CMOS HANDLING PRECAUTIONS................................................................................................8
WARRANTY ................................................................................................................................8
FOR YOUR SAFETY AND THAT OF YOUR PATIENTS ........................................................................9
READ INSTRUCTIONS FOR USE ....................................................................................................9
MAINTENANCE ...........................................................................................................................9
LIABILITY FOR PROPER FUNCTION AND DAMAGE .........................................................................10
INTENDED USE .........................................................................................................................11
CONTRAINDICATIONS ...............................................................................................................11
ADVISE FOR USE ......................................................................................................................11
SCOPE OF SUPPLY ...................................................................................................................12
INTERVALS FOR MAINTENANCE .................................................................................................13
OPERATORS INTERFACE ...........................................................................................................14
OPERATORS INTERFACE AND MENU STRUCTURE .......................................................................14
DISPLAY ..................................................................................................................................16
CONTROLS AND CONNECTIONS .................................................................................................17
ALARM & ERROR CODES ..........................................................................................................20
ALARM PRIORITY ......................................................................................................................20
PATIENT ALARMS......................................................................................................................21
SENSOR ALARMS......................................................................................................................23
SYSTEM ALARMS ......................................................................................................................25
PREPARATION, CLEANING STERILISATION ..................................................................................27
TROUBLESHOOTING .................................................................................................................29
TECHNICAL DATA......................................................................................................................30
SETTINGS ................................................................................................................................30
MEASURED PARAMETERS .........................................................................................................30
DIMENSIONS ............................................................................................................................33
CONNECTIONS .........................................................................................................................33
ENVIRONMENTAL CONDITIONS ..................................................................................................33
DISPOSAL OF BATTERIES AND OXYGEN SENSORS ......................................................................34
EXCHANGE OF FUSES ...............................................................................................................35
PREVENTIVE MAINTENANCE......................................................................................................36
RECOMMENDED SERVICE PROCEDURE .....................................................................................36
REPLACING AIR AND O2 INLET FILTERS .....................................................................................37
REPLACING OXYGEN SENSOR ...................................................................................................38
REPLACING AIR / OXYGEN BLENDER .........................................................................................38
REPLACING INLET PRESSURE REGULATORS ...............................................................................39
CALIBRATION ...........................................................................................................................40
EQUIPMENT .............................................................................................................................40
CALIBRATION PRESSURE SENSOR .............................................................................................41
CALIBRATION EXHALTION VALVE ...............................................................................................42
CALIBRATION INPUT PRESSURE REGULATORS............................................................................43
TESTING INSTRUCTIONS ...........................................................................................................43
EQUIPMENT .............................................................................................................................44
TEST .......................................................................................................................................44
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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 re-
sponsibility and liability for the above.
All maintenance performed within the applicable warranty period must be authorized in ad-
vance by a ACUTRONIC Medical Systems AG service representative in order to retain the
warranty status of the subject unit.
Statements in the operating instructions preceded by words “Warning,” “Caution,” and “Note”
carry special significance. The definitions of these words are as follows:
WARNING !
Means there is a possibility of injury to oneself or others
CAUTION !
Means there is a possibility of damage to the instrument or other property
NOTE !
Indicates points of particular interest for more efficient and convenient

operation.
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FOR YOUR OWN AND YOUR PATIENTS SAFETY
Read instructions for use
Before the use of FABIAN neonatal and infant ventilator on a patient read the instructions for
use and make sure to proper understand all functions of the equipment.
FABIAN is intended to be used by physicians only or under their direct control or direction.
Before attempting to use FABIAN in an actual life–supporting situation, the operating per-
sonnel must become practiced in FABIANs functions and all effects of the various controls.
Please review this manual thoroughly and operate FABIAN in simulated situations before the
dedicated use.
Warnings
FABIAN shall only be used by or on the order of a physician.

FABIAN shall only be used under supervision of qualified personnel to make sure, that
in case of a malfunction of the equipment, corrective action is taken immediately.
At the same time of the use of FABIAN, an independent ventilation method such as for
example a manual resuscitator, must be available at all times.
In case of a visible malfunction of FABIAN when its life supporting function is no
longer guaranteed, FABIAN must be replaced immediately by an independent ventila-
tion method such as for example a manual resuscitator.
Never use FABIAN in combination with flammable anaesthetics. FABIAN shall be used
with air and oxygen only.
Acoustic and visible alarms indicate either a patient or a system alarm and require
immediate action of qualified medical personnel.
If during the self–check or system test a failure or malfunction is recognised, under no
circumstances FABIAN shall be used on a patient.
The use of FABIAN connected with electrical or electronically equipment others than
those mentioned in this instruction for use are not permitted. Contact ACUTRONIC
Medical Systems AG in case of special requests.
It is not allowed to cover or to set up FABIAN so that its operation is influenced nega-
tively.
Only a qualified and trained technician is entitled to do open the housing of FABIAN.
In any case, before opening the housing, the power cord must be disconnected.
To avoid any malfunctions of FABIAN based on radio frequency, do not use any cellu-
lar phone closer than 10 m to it.
Mobile phones may cause malfunctions to electro medical equipment.
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It is not allowed to use antistatic or electrically conductive hoses.
ABBREVIATIONS AND SYMBOLS
Symbol Description
Read instructions for use! Important Reference or alarm

flag
Class BF equipment
High voltage. Disconnect power cord before opening of the

enclosure. FABIAN shall be opened by a qualified techni-
cian only.
Potential compensation
OI Power ON / OFF whereby O = OFF I = ON
SHARE Minute volume given by the ventilator

ASSIST Assist–mode; each inspiratory effort from the patient which
exceeds the set limit releases a mandatory breath from the
ventilator, parameters according TI, PIP
BASE FLOW Minimum flow, which circulates during exhalation phase in
the system
C20/C Dynamic compliance of the last 20% of the inspiratory
phase of a mechanical breath, compared to the compli-
ance of the complete breath. Indicator for over distension
of the lung.
CPAP Continuous Positive Airway Pressure
DYN COMPL Dynamic compliance of the lung. Indicator for elasticity of
lung tissue
E TIME Expiratory time
BRTH RATE Breath rate per minute
I TIME Inspiratory time
INSP FLOW Inspiratory flow; flow during inspiratory phase of mechani-
cal breath
IPPV Intermittent Positive Pressure Ventilation
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IMV Intermittent Mandatory Ventilation
CONTROL Controlled ventilation
LEAK Endotracheal tube leakage
MIN FLOW Minimal flow, in case of a loss of the PEEP, it is automati-
cally increased to compensate for the leak
MV TOTAL Minute Volume of mechanical breath and spontaneous ac-
tivity
OXYGEN Inspiratory oxygen concentration
O2 FLUSH Oxygen flush
P INSP Inspiratory pressure
PEAK PRESS Peak inspiratory pressure
MEAN PRESS Mean airway pressure
PEEP Positive End Expiratory Pressure
RESISTANCE Airway resistance
SIMV Synchronized Intermittent Mandatory Ventilation
TRIG LEVEL VOL Trigger sensitivity; 0 = most sensitive, 10 = least sensitive
TRIGGER VOL Required volume to release mechanical breath
TRIGGER Function to allow synchronisation of ventilator with patients
breathing pattern
VTe Expiratory tidal volume
VTe avrg Averaged exhaled tidal volume
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CMOS HANDLING PRECAUTIONS
The following precautions must be observed whenever a circuit board or an integrated circuit is
handled. Failure to do so may result in serious damage to the FABIAN.
Place FABIAN and parts on a grounded, conductive work surface
Ground yourself (with a strap having about 1 MOhm resistance?
Ground the frame of any test instrument or soldering iron to be used
If any circuit boards are to be stored or transported, enclose them in conductive (anti-static) enve-
lopes
WARRANTY
We warrant that this product is free from defects in material and workmanship and, when properly
used, will perform in accordance with applicable specifications. If within one year after the original
shipment it is found not to meet this standard, it will be repaired, at Acutronic Medical Systems AG
option, or replaced at no charge when returned to an Acutronic Medical Systems AG service facil-
ity. Any modification to the equipment or rework or repair by other than Acutronic Medical Sys-
tems 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
ten years after the original shipment and to make this capability available at the then prevailing
schedule of charge.
All maintenance performed within the applicable warranty period must be authorized in advance
by a ACUTRONIC Medical Systems AG service representative in order to retain the warranty
status of the subject unit
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FOR YOUR SAFETY AND THAT OF YOUR PATIENTS
Read instructions for use
For correct and effective use of the apparatus and to avoid hazards it is essential to read the fol-
lowing recommendation and to act accordingly. Any use of the apparatus requires full understand-
ing and strict observation of these instructions. The apparatus is only to be used for purposes
specified here.
Maintenance
FABIAN is a Neonatal and Infant Ventilator and classified as Il b according all applicable re-
quirements for Medical Products according 93/42 EWG council of European Union dated
June 14th, 1993 for Medical Products.
1.) The apparatus must be inspected and serviced by experts at regular 6 months interval
(and a record kept).
2.) We recommend obtaining a service contract with ACUTRONIC Medical Systems AG ex-
clusive distributor in your country.
3.) Repairs and general overhaul on the apparatus may only be carried out by ACUTRONIC
Medical Systems AG Service.
4.) Only original ACUTRONIC Medical Systems AG spare parts may be used for mainte-
nance.
5.) Power connection: The apparatus is to be used only in rooms with mains power supply
installations complying with national standards. The standards laid down in IEC-601/1
Safety for Medical Electrical Equipment, are applicable for electrically powered equip-
ment.
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Liability for proper function and damage
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 em-
ployed 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 provi-
sions of the terms of sale and delivery of ACUTRONIC Medical Systems AG are likewise not
modified by the recommendations mentioned above.
Service: measures to maintain desired condition

Repair: measures to restore desired condition
Maintenance: inspection, service and if applicable, repair
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Intended use
FABIAN neonatal and invant ventilator is an intensive care ventilator for premature babies,
neonates and infants up to 30 kg bodyweight.
FABIAN incorporates the following ventilation modes:
- Intermittent Positive Pressure Ventilation (IPPV)

- Synchronised Intermittent Mandatory Ventilation (SIMV)
- Assist Controlled Ventilation (ASSIST)
- Continuous Positive Airway Pressure Ventilation (CPAP)
Contraindications
There are no contraindications known.
For further product information, please contact:

Haldenstrasse 3
P.O Box 2082
6342 Baar
Switzerland
Advise for use
In case of a visible malfunction of FABIAN, were its proper life support is no longer guaran-
teed, FABIAN must be replaced immediately with an independent manual ventilation equip-
ment, such as a for example a resuscitator.
During the ventilation, regular blood gas control shall be performed. Continuous su-
pervision of SaPO2 and CO2 with pulsoximetry or transcutaneous blood gas monitor
is recommended.
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Scope of supply
The following items are supplied with the standard configuration:
- FABIAN neonatal and infant ventilator

- NIST adapter “Air”
- NIST adapter “Oxygen”
- Power cord
- Test lung
The following items are additionally available:
- Heated patient circuit

- Unheated patient circuit
- Humidifier and accessories
- Trolley for FABIAN
- Flow sensor
- Flow sensor cable
- Water chamber
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Intervals for Maintenance
FABIAN and accessories must be cleaned and sterilised prior any maintenance or repair
work, also in case of returning FABIAN to ACUTRONIC Medical Systems AG.
Every 6 month
- Maintenance and electrical safety check with protocol (IEC 601-1)
- Check alarm limits for proper function
- Check connections for air and oxygen (Leak test)
- Check mechanical and electrical connections
Every 12 month
- Maintenance and electrical safety check with protocol (IEC 601-1)
- Check alarm limits for proper function
- Check connections for air and oxygen (Leakage test)
- Check mechanical and electrical connections
- Calibration
Replace following components:

- O2-Sensor
- Air and O2 inlet filter
If O2-Sensor alarm is displayed, the sensor must be replaced at earli-

est convenience to assure a proper function of apparatus. Disposal of
old sensor like battery according local rules.
Every 10000 hours Replace following components:

- Air / Oxygen blender
- Input pressure regulators
Every 3 years Internal tube set
Repairs and general overhaul of FABIAN shall be carried out by ACUTRONIC Medical
Systems AG trained and authorised service personnel only.
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OPERATORS INTERFACE
Operators interface and menu structure
Fabian
Self test: MEDICAL
SYSTEMS
When FABIAN is switched on, the

main menu is displayed. In the main
menu the ventilation mode as well as
the ventilation parameters can be
changed.
The ventilation mode is changed by

pressing the key “MODE” and thereaf-
ter the function key below the required MODE
mode of operation.
Manual
Fabian
MEDICAL
SYSTEMS
Parameter setting:
To change the ventilation parameters,

the key symbol must be pressed to
activate the cursors function. Move the
cursor with the alpha dial knob (rotat-
ing knob) to the desired parameter.
MODE
Manual
Fabian
MEDICAL
SYSTEMS
Press the alpha dial knob to select the

parameter and rotate knob clockwise
to increase or counter-clockwise to
decrease the value. The change is
accepted by pressing the knob again
or automatically after 10 seconds.
MODE
Manual
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To avoid incorrect settings, safety
functions are built in. For example,
inspiratory pressure must be set at
least 5 cmH2O higher than the set
PEEP level. If you try to select a value
with less than 5 cmH2O differences,
the message “END OF RANGE” is
displayed. At the same time it is indi-
cated, which parameter must be
changed.
If a parameter has been changed, for

example the inspiration pressure, for a
limited time period, the key symbol will
appear next to the value and you hear
the acoustic alarm.
To accept this value the key symbol

must be pressed. As long as the pa-
rameter is above the limit, next to the
value the alarm flag is shown.
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Display
Measured Paramters
Ventilation - Parameters Ventilation - Mode Button O2 - Flush
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Controls and connections
1 2
Fabian
MEDICAL
SYSTEMS
3
4
5
6
10
11
MODE
Manual
20 19 18 17 16 15 14 13 12
Legend to front panel
1 Display for parameters and measured values

2 LED, blinking in case of a system failure
3 LED, blinking in case of a patient alarm condition
4 LED, blinking in case of power failure
5 LED, is light on in case of the acoustic alarm suppression
6 Button for acoustic alarm suppression
7 Button to enter the alarm menu
8 Button with double function, display contrast or cursor movement upwards
9 Button with double function, display bright or change of scaling factor in manual
scale mode.
10 Button with double function, display contrast or cursor movements downwards.
11 Button with double function, display dimmed or change of scaling factor in manual
scale mode.
12 Connection for inspiratory limb
13 Alpha dial knob
14 Key button
15 Proximal airway pressure connection
16 Mode button; switches between monitoring or ventilator mode
17 Function keys
18 Button for calibration menu
19 Menu button
20 Connection for expiratory limb (exhalation valve)
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Rear panel:
1 2 3 4 5 6
7 8 9 10
Legend to rear panel:
1 Main switch ON / OFF

2 Fuse holder
3 Mains plug
4 Ground
5 RS 232 interface
6 Connection for flow sensor
7 NIST inlet adapter for compressed air
8 Inlet control pressure air
9 Inlet control pressure air
10 NIST inlet adapter for oxygen
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ALARM & ERROR CODES
Alarm priority
Depending on the alarms, the appliance distinguishes between two priorities and marks it
with a specific sound:
Priority 1: An immediate action necessitates to the prevention of a live–threatening condi-

tion, for example disconnected hoses. The tone of the alarms sounds in fast se-
quences.
Priority 2: An immediate action is necessary to avoid a live–threatening situation. Acted

suitably, the action should be completed after 2 minutes at the latest. The tone of the alarm
sounds in slow sequences.
ALARM Priority
INTERNAL ERROR 1
OXYGEN SENSOR DEFECT 1
OXYGEN VALUE DIVERGENCE 1
SENSOR DEVIATION PROXIMAL PRESSURE 1
INPUT PRESSURE BLENDER 1
EXCESS PRESSURE 1
INTERNAL FAILURE 1
VOLTAGE MONITORING 1
INPUT PRESSURE OXYGEN SUPPLY 1
INPUT PRESSURE AIR SUPPLY 1
EXHALATORY TUBE 1
INSPIRATORY TUBE 1
PATIENT DISCONNECT 1
FLOW SENSOR FAILURE 2
FLOW SENSOR DISCONNETED 2
CLEAN FLOW SENSOR 2
MINUTE VOLUME TOO HIGH 2
MINUTE VOLUME TOO LOW 2
VOLUME TOO HIGH 2
LEAKAGE TOO HIGH 2
FREQUENCY TOO HIGH 2
APNOE – ALARM 1
PRESSURE TOO HIGH 2
PRESSURE TOO LOW 2
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Patient alarms
In case of a patient alarm, an acoustic alarm sounds and the red LED with the bell symbol is
flashing. FABIAN enters automatically into the alarm setting screen.
Next to the value that the set threshold was exceeded, a black bell symbol appears.
Press the to mute the acoustic alarm for the next 60 seconds. Appropriate actions
can be taken now to clear the alarm situation. Eventually the alarm threshold must be
adjusted. If the alarm condition is cleared, the acoustic alarm is reset and the black bell turns
into grey.
After clearing the alarm cause, press the key to reset the alarm. This has to be done
also, if FABIAN has not been used the following 2 minutes after the alarm reset.
Sensor alarms are high priority alarms and may, interrupt a patient alarm.
The screen during a patient alarm is the same as during the alarm setting.
Alarm screen while alarm condition is still not cleared.
Alarm screen after clearance of the alarm condition
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Sensor alarms
The screen for the sensor alarms is the same as the one for sensor calibration. Error mes-
sages are displayed as text messages.
The following error messages may be displayed:
Sensor Message Cause

Flow sensor SENSOR DISCONNECTED The flow sensor or its cable is
not connected to the device
Flow sensor SENSOR DEFECT One of the sensor hot wires is
broken or there is a cable
problem.
Flow sensor CLEAN FLOW SENSOR Dirty sensor
Oxygen sensor REPLACE O2-SENSOR The oxygen sensor lifetime is
finished and it must be ex-
changed
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The alarm “CLEAN SENSOR“ can be reset after cleaning of the sensor. This is done by
pressing the function key “FLOW” or “MENU“
Always make sure that in case of the “CLEAN SENSOR” alarm, you recalibrate the sensor
and make sure there is no excessive amount of water in the patient circuit. Make sure there
is no secretion from the patient occluding the sensor or Y–piece. Both ends of the sensor
have a filter to protect from damage.
If during operation, the flow sensor is exchanged, the flow sensor can be deactivated by
pressing the key “FLOW SENSOR SWITCHED OFF” for this procedure without interruption
of the ventilation. However, the flow monitoring function is disabled during this period. After
exchange of the flow sensor, make sure to reactivate the flow sensor again by pressing “AC-
TIVATE FLOW SENSOR”.
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System alarms
There are two different types of system failures and alarms. One group is the ”OPERATOR
FAULTS” and the other group is ”DEVICE DEFECTS”. The following graphic indicates an
occlusion of the inspiratory limb. As long as the alarm condition is present, the bell symbol is
black.
As soon as the alarm condition is cleared, the bell symbol becomes empty and the acoustic
signal is ceased. See following graphic.
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Error Message Cause
None or not sufficient gas
OPERATOR
INPUT PRESSURE OXYGEN SUPPLY supply pressure in oxygen
FAULTS
supply
OPERATOR
GAS SUPPLY PRESSURE AIR No or not sufficient air supply
FAULTS
OPERATOR
EXHALATORY TUBE Occlusion in expiratory limb
FAULTS
OPERATOR
INSPIRATORY TUBE Occlusion in inspiratory limb
FAULTS
DEVICE Inlet pressure on blender too
INPUT PRESSURE BLENDER
DEFECTS low
DEVICE Measured and set oxygen do
OXYGEN VALUE DIVERGENCE
DEFECTS not match
DEVICE Oxygen sensor not connected
OXYGEN SENSOR DEFECT
DEFECTS or broken
DEVICE
EXCESS PRESSURE
DEFECTS
DEVICE
VOLTAGE MONITORING Inlet voltage too low
DEFECTS
If the gas supply fails, FABIAN does not automatically switch to the remaining gas.
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PREPARATION, CLEANING STERILISATION
Following each patients use, or if necessary more frequently, it is important to clean the exte-
rior of FABIAN as well as to disassemble and clean the various components of the patient
breathing circuit system, exhalation valve, and air inlet water trap. Before cleaning FABIAN,
the exterior of the ventilator and humidifier must be unplugged. FABIAN and the pedestal
stand can be disinfected by wiping the exterior with an appropriate bactericidal or germicidal
agent. Care should be taken not to allow any liquid to penetrate the inside of the ventilator.
In no case, FABIAN itself shall be sterilised. Only use wiping disinfections with for
instance Buraton 10 F or Terralin (Schülke & Mayr, Norderstedt, Germany).
Carefully follow the instructions for use of the manufacturer.
Recommendation:
The patient circuit must be changed after each patient or every 48 hours. This is to avoid
contamination of the next patient. For this the following procedures can be used:
Sterilisation of accessories:
Flow sensor • Rinse the sensor head immediately after use and immerse it in
(without cable!!) a liquid disinfectant, otherwise it will encrust and become unfit
for use. Do not use high–pressure air to dry sensor. It is rec-
ommended that gas, steam or liquid sterilisation process such
as Alhydex, Glutarex, and CIDEX or similar is used. .
• Do not clean the sensor with pressure air or a hard water
jet, as the sensor wires can be harmed. Do not use clean-
ing or disinfections automats to clean the sensor
• Steam sterilisation at 134°C
• Exchange the sensor daily. This increases lifetime of the
sensor.
• Never use a non–calibrated sensor on a patient. Always cali-
brate the sensor before its use.
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Exhalation valve • Wet cleaning with warm water or in washing machine at 93°C /
10 min.
Proximal airway pres-

After that:
sure tube
• Steam sterilisation at 134°C for 10 minutes

• Sterilise the exhalation valve to dry out water
Breathing circuits • Wet cleaning with warm water or in washing machine at 93°C /
10 min.
After that:

• After sterilisation process test for leakage
Y – piece • Wet cleaning with warm water or in washing machine at 93°C /

10 min.
After that:

• After sterilisation process test for leakage
Heating wire • Steam sterilisation at 134°C

Dual airway tempera- • Wipe with alcohol, don’t sterilise
ture probe
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TROUBLESHOOTING
Alarm – Message Cause Corrective action

Change in lung compli- Reduce PIP or change
MV HIGH
ance limit
Change in lung compli- Increase PIP or change
MV LOW
ance limit
VOLUME LIMIT Clinical
LEAK ET tube to small Clinical
HIGH RATE Hyperventilation Clinical
APNEA
P (PRESSURE)
FLOW SENSOR Flow sensor or sensor
Change sensor
NOT CONNECTED cable not connected
Sensor wire is broken or
SENSOR DEFECT a wire within the sensor Change sensor
cable
CLEAN FLOW SEN-
Flow sensor is dirty Clean sensor
SOR
REPLACE Oxygen sensor is used
Change sensor
O2 - SENSOR up or must be exchanged
INPUT PRESSURE Pressure in oxygen sup-
Check O2 supply
OXYGEN SUPPLY ply is missing or too low
INPUT PRESSURE Pressure in air feed is too
Check air supply
AIR SUPPLY high or low
EXHALATORY TUBE Check expiratory limb
INSPIRATORY TUBE Check inspiratory limb

INLET PRESSURE
Call service
BLENDER
OXYGEN VALUE
Call service
DIVERGENCE
OXYGEN SENSOR
Change O2 sensor
DEFECT
EXCESS PRESSURE Check POP off valve
VOLTAGE MONI-
Call service
TORING
INTERNAL ERROR Call service
SENSOR DEVIATION
PROXIMAL PRES- Call service
SURE
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TECHNICAL DATA
Settings
• Inspiratory time (I time) 0.1 – 2.0 sec

• Expiratory time (E time) 0.2 – 30 sec
• Insp. flow neonatal 1 – 20 lpm
Paediatric 2 – 40 lpm
• Base flow neonatal 2 –10 lpm
Paediatric 4 – 10 lpm
• PEEP 0 – 20 cmH2O
• PIP 6 – 60 cmH2O
• O2 – concentration 21 – 100 Vol % O2
• Rate 2 – 200 bpm
• Trigger level 1 – 10
• CPAP 0 – 20 cmH2O
• Min. flow (CPAP) 4 – 10 lpm
• System resistance with 30 lpm < 20 mbar/L/s
• Inspiratory resistance < 12 mbar/L/s
• Expiratory resistance < 8 mbar/L/s
Measured parameters
• PIP (PEAK PRESS)

- Range: 0 –100 cmH2O
- Dissolution: 1 cmH2O
- Accuracy: ± 5%
• MAP (MEAN PRESS)

- Range: 0 –100 cmH2O
- Accuracy: ± 5%
• PEEP
- Range: -10 – 100 cmH2O
- Accuracy: ± 5%
• Minute volume
- Neonatal: 0 – 9.99 l ± 8% ± 10 ml
- Infant: 0 – 99.9 l ± 8% ± 100 ml
• Tidal volume
- Neonatal: 0 – 999 ml ± 8% ± 0.1 ml @ Vte < 100 ml
± 8% ± 1.0 ml @ Vte >= 100 ml
- Infant: 0 – 9.99 l ± 8% ± 1.0 ml @ Vte < 1l
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± 8% ± 10.0 ml @ Vte >= 1l
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• ET tube leakage
- Range: 10 – 50%
- Dissolution: 5%
- Accuracy: ± 10%
• Dynamic compliance
- Range: 0 – 500 ml/cmH2O
- Dissolution:
Neonatal 0.1 ml/cmH2O
Infant 1 ml/cmH2O
- Accuracy: -23% – 28%
• Airway resistance
- Range: 0 – 5000 cmH2O/lps
- Dissolution:
Neonatal 0.1 cmH2O/lps
Infant 0.1 cmH2O/lps
- Accuracy: -24% – 26%
• FiO2 concentration
- Range: 18 – 100%
- Dissolution: 1%
- Accuracy: ± 3 vol. %
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Dimensions
WxHxD 35 cm x 19 cm x 34 cm
Weight 6.5 kg
Connections
Medical grade compressed air 2.0 – 6.5 bar

Oxygen 2.0 – 6.5 bar
Power supply 100 – 240 VAC 50/60 Hz
Environmental conditions
Usage
Temperature 15°C – 40°C
Air pressure 700 – 1060 hPa
Rel. air humidity 30% – 90%, non condensing
Transport and storage

Temperature -20°C – 60°C
Air pressure 500 – 1060 hPa
Rel. air humidity 10% – 100%, non condensing
17.12.2005 33/48
Disposal of batteries and oxygen sensors
Disposal of oxygen sensors
• Do not put oxygen sensors, explosion hazard!
• Do not oxygen sensors. Risk for chemical poisoning!
Please dispose the oxygen sensors in the same way as the batteries.
Local authorities will provide the local hazardous waste disposal guidelines.
17.12.2005 34/48
Exchange of fuses
General note:
Fuses shall be replaced by fuses of the same type and value indicated on FABIAN only.
ACUTRONIC Medical Systems AG recommends the exchange of fuses by authorised ser-
vice personnel only.
The main fuses are located in the fuses compartment of the power entry module at the rear
panel of FABIAN.
Procedure:
1. Disconnect power cord from machine to avoid electrical shock!
2. With a screwdriver, open the fuses compartment. Pull out the drawer, which contains
the fuses.
3. Exchange the fuses with fuses of the same type and value.
4. Install the compartment back.
5. Make sure, that the arrow directs to the right side.
6. The correct values for the fuses are indicated on the label above the power entry
module.
17.12.2005 35/48
PREVENTIVE MAINTENANCE
WARNING
Hazardous voltages exist within the ventilator. Always observe appropriate safety
precautions when working on the ventilator while the machine is connected to an
electrical power source to prevent possible accidental injurious electrical shock.
WARNING
After calibration and/or replacement of any assembly(ies), always repeat the com-
plete test procedure according the FABIAN checklist.
Recommended Service Procedure
Preventive maintenance on the FABIAN Neonatal and Infant Ventilator should be completed
minimum once each year. Maintenance is intended to be done in the hospital by an ACUTRONIC
Medical Systems AG authorized service technician or a ACUTRONIC Medical Systems AG
trained hospital service technician.
FABIAN preventive maintenance includes:
- Visually inspecting and cleaning of external surfaces, controls, attach-

ments and accessories (every 6 months)
- Opening and cleaning the interior of the unit (every 6 months)
- Visually inspecting all tubing, electrical wiring, connectors, crimps,

screws and hardware (every 6 months)
- Checking the general condition of all other internal components or as-

semblies (every 6 months)
- Replacing Air and O2 inlet filters (every 12 months)
- Replacing Oxygen sensor (every 12 months)
- Replacing Air / Oxygen blender (every 10000 hours)
- Replacing inlet pressure regulator (every 10000 hours)
- Replacing internal tubes (every 3 years)
- Performing a calibration (every 12 months)
- Performing a complete test according FABIAN checklist
17.12.2005 36/48
Replacing Air and O2 inlet filters
screw Inltet filter
17.12.2005 37/48
Replacing Oxygen sensor
Replacing Air / Oxygen blender
AIR / O2 blender
17.12.2005 38/48
Replacing inlet pressure regulators
Pressure regulator AIR

Pressure regulator O2
17.12.2005 39/48
CALIBRATION
IMPORTANT
Before you start with the calibration the unit should be switch on for 15 min.
WARNING
Hazardous voltages exist within the ventilator. Always observe appropriate safety
precautions when working on the ventilator while the machine is connected to an
electrical power source to prevent possible accidental injurious electrical shock.
WARNING
After calibration and/or replacement of any assembly(ies), always repeat the com-
plete test procedure according the FABIAN checklist.
Equipment
- Pressure meter
- Oxygen analyser
- Neonatal / Pediatric test lung (part no. 1116)
- T –Adapter for oxygen sensor (part no. 1069)
- Adjustable pressure regulator (0 – 100 cmH2O)
- Safety Tester
- Service Manual FABIAN
- Test protocol FABIAN
17.12.2005 40/48
Calibration pressure sensor
- Press button until the menu screen of FABIAN appears. Press the two but-
tons and simultaneously to get into the System maintenance menu.

Press CAL SYSTEM button.
- Press button 0 cmH2O

IMPORTANT: During this step, the airway pressure input nipple must be free. No tube
connected !
- Connect the airway pressure input nipple with an adjustable pressure regulator and
measure the pressure simultaneously with an external pressure meter. Increase the
pressure until the external pressure meter shows 60 cmH2O and press button 60
cmH2O on the FABIAN.
- Press button RETURN on the FABIAN as often until the main menu appears on the
screen.
17.12.2005 41/48
Calibration exhalation valve
- Set following values in the IPPV mode:
Insp. Flow: 10 lpm

Basis Flow: 5 lpm
PEEP: 10 cmH2O
Insp. Pressure: 50 cmH2O
Frequency 30
I-Time: 1 Sek.
- Press button until no frame is activ
- Press the two buttons and simultaneously to get into the exhalation
valve calibration
- The message "Calibrate Exhalation Valve" appears on the screen.
- The calibration is done as soon the values Pinsp 50 cmH2O / Pmean 29 cmH2O /
PEEP 11 cmH2O are reached.
MODE
- Press button to close the calibration procedure.
17.12.2005 42/48
Calibration input pressure regulators
- Set following values in the IPPV mode:
Insp. Flow: 20 lpm

Basis Flow: 10 lpm
PEEP: 10 cmH2O
Insp. Pressure: 50 cmH2O
Frequency 15
I-Time: 2 Sek.
Oxygen: 21 %
- Connect to flow meter at the inspiration limp

- Turn at the air input pressure regulator at the back panel until flow meter 20 lpm
- Set oxygen value to 100 %
- Connect to flow meter at the inspiration limp

- Turn at the oxygen input pressure regulator at the back panel until flow meter 20 lpm
17.12.2005 43/48
TESTING INSTRUCTIONS
IMPORTANT
Before you start with the test procedure the unit should be switch on for 15 min.
Equipment
- Pressure meter
- Oxygen analyser
- Neonatal / Pediatric test lung (part no. 1116)
- T –Adapter for oxygen sensor (part no. 1069)
- Glass bottle 1 l
- Safety Tester
- Service Manual FABIAN
- Test protocol FABIAN
Test
FABIAN Settings:
- Mode: IPPV
- P Insp. 20 cmH2O
- PEEP 5 cmH2O
- Base flow: 5 lpm
- Insp. Flow: 10 lpm
- Frequency: 30
- I –Time: 0.4 sec
- Oxygen: 21 %
1. Test of LED displays and acoustic alarms
1.1 Connect FABIAN to 230 VAC and switch the unit. Control display backlight.
1.2 Check alarm sound
1.3 Remove power cord from the wall socket. Acoustic Power failure alarm and red LED
(Power fails) flashes
1.4 Press button alarm sound off.
17.12.2005 44/48
2. Patient alarms
2.1 Set limit "Leak" 10 % and open red stopcock on the testlung, close red stopcock after
the message "leakage too high" appeared on the display.
2.2 Set lower minute volume limit to 2.0 lpm. Set limit back after the message "Minute
volume too low" appeared on the display.
2.3 Set upper minute volume limit to 0.1.0 lpm. Set limit back after the message "Minute
volume too high" appeared on the display.
2.4 Set frequency to 40. Set limit back after the message "Frequency too high" appeared
on the display.
2.5 Change to CPAP mode. After 20 sec. alarm "APNEA" appears. Reset FABIAN to
IPPV mode.
3. Flow sensors alarms
3.1 Disconnect flow sensor.

3.2 Connect a defective flow sensor
4. Pressure measurements
FABIAN Settings:
- Mode: IPPV
- P Insp. 10 cmH2O
- PEEP 5 cmH2O
- Base flow: 5 lpm
- Frequency: 30
- Oxygen: 21 %
Press button and switch off the flow sensor
4.1 Read the values Pmax, Pmean and PEEP from the FABIAN and fill it into the table.
The values should be within the tolearance.
4.2 Set P Insp. and PEEP according the table and fill the values into the table. The val-
ues from the FABIAN should be within the tolerance.
17.12.2005 45/48
5. Volume calculations
FABIAN Settings:
- Mode: IPPV
- P Insp. 10 cmH2O
- PEEP 5 cmH2O
- Base flow: 5 lpm
- Frequency: 30
- Oxygen: 21 %
Press button and switch on the flow sensor
5.1 Read the values MV, Vte and Compliance from the FABIAN and fill it into the table.
The values should be within the tolerance.
5.2 Set P Insp. and PEEP according the table and fill the values into the table. The val-
ues from the FABIAN should be within the tolerance.
6. Oxygen measurement
6.1 Connect a external Oxygen analyser with the inspiratory tube of the FABIAN an com-
pare oxygen measurements from the FABIAN with the oxygen analyser.
7. System alarms
7.1 Disconnect oxygen gas supply

7.2 Disconnect air gas supply
7.3 Kink expiratory tube
7.4 Kink inspiratory tube
7.5 Disconnect oxygen gas supply, mute the alarm and set oxygen to 100%. After 20 sec.
alarm "Oxygen value divergence" should appear.
7.6 Kink airway pressure tube
17.12.2005 46/48
Pneumatic Schema FABIAN
5 6
3
1 2 P 5
6
Air 10 11
8
5 O2
6 P
7
9
14 Inspiration
5
6
5
6
Oxygen
5 12
1 2
P 6
3 P
Exspiration
13
Legend:
1 Inlet filter
2 Pressure reduction unit
3 Pressure transducer
4 Air / Oxygen blender
5 Blender Solenoid valve (10 pcs. Air, 10 pcs. Oxygen)
6 Sapphire nozzle (10 pcs. Air, 10 pcs. Oxygen)
7 Demand recoil nozzle
8 Bleed valve
9 Pneumatic pressure relief valve
10 Dual Oxygen transducer
11 Pressure transducer in inspiration circuit
12 Proximal pressure transducer at Y-piece
13 Exhalation solenoid
14 Micro filter

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FABIAN

ACUTRONIC Medical Systems AG

Phone: +41 44 729 70 80

Service Manual FABIAN 1.1

Service Manual FABIAN 1.1

Means there is a possibility of injury to oneself or others

Means there is a possibility of damage to the instrument or other property

Indicates points of particular interest for more efficient and convenient

Service Manual FABIAN 1.1

Read instructions for use

FABIAN shall only be used by or on the order of a physician.

Service Manual FABIAN 1.1

ABBREVIATIONS AND SYMBOLS

Read instructions for use! Important Reference or alarm

High voltage. Disconnect power cord before opening of the

OI Power ON / OFF whereby O = OFF I = ON

SHARE Minute volume given by the ventilator

Service Manual FABIAN 1.1

Service Manual FABIAN 1.1

Place FABIAN and parts on a grounded, conductive work surface

Ground yourself (with a strap having about 1 MOhm resistance?

Ground the frame of any test instrument or soldering iron to be used

THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED,

Service Manual FABIAN 1.1

Read instructions for use

Service Manual FABIAN 1.1

ACUTRONIC Medical Systems AG

Service: measures to maintain desired condition

Service Manual FABIAN 1.1

FABIAN incorporates the following ventilation modes:

- Intermittent Positive Pressure Ventilation (IPPV)

There are no contraindications known.

For further product information, please contact:

ACUTRONIC Medical Systems AG

Advise for use

Service Manual FABIAN 1.1

The following items are supplied with the standard configuration:

- FABIAN neonatal and infant ventilator

The following items are additionally available:

- Heated patient circuit

Service Manual FABIAN 1.1

Replace following components:

If O2-Sensor alarm is displayed, the sensor must be replaced at earli-

Every 10000 hours Replace following components:

Every 3 years Internal tube set

Service Manual FABIAN 1.1

Operators interface and menu structure

When FABIAN is switched on, the

The ventilation mode is changed by

To change the ventilation parameters,

Press the alpha dial knob to select the

Service Manual FABIAN 1.1

If a parameter has been changed, for

To accept this value the key symbol

Service Manual FABIAN 1.1

Ventilation - Parameters Ventilation - Mode Button O2 - Flush

Service Manual FABIAN 1.1

Legend to front panel