IFU Fabian HFOi 3 4 English

Ventilation Beyond Limits
fabian HFOi
Instructions for Use SW 3.4
Warning
Carefully read the instructions of use
before using the ventilator to
familiarise yourself with the function of
the equipment
DISCLAIMER
Acutronic Medical Systems assumes no responsibility for the use or reliability of its software on equipment
that is not furnished by Acutronic Medical Systems.
Acutronic Medical Systems makes no warranty of any kind with regard to software applications that are
created by the user.
This document contains confidential and proprietary information that is protected by copyright. All rights
are reserved. Any unauthorized copying, storage, reproduction or translation of this document in any form is
strictly prohibited.
Manufacturer:
ACUTRONIC Medical Systems AG
Fabrik im Schiffli
8816 Hirzel / Switzerland
2 / 99 fabian HFOi | SW 3.4

Table of Contents
1. Working with the instructions ................................................................. 8
1.1 Document Structure .................................................................................................................................................. 8
1.2 Notices and Warnings................................................................................................................................................ 8
1.3 Hardware Version Identification .............................................................................................................................. 9
1.4 Symbols ....................................................................................................................................................................... 9
2. General Notices ..................................................................................... 11

2.1 Always Observe ........................................................................................................................................................ 11
2.2 Maintenance ............................................................................................................................................................. 12
2.3 Liability for Functionality / Damages .................................................................................................................... 13
2.4 Intended use ............................................................................................................................................................. 13
2.5 Scope of Delivery...................................................................................................................................................... 13
2.6 Contra-indications ................................................................................................................................................... 14
3. System overview ................................................................................... 15

3.1 Front Connections ................................................................................................................................................... 15
3.2 Rear Panel ................................................................................................................................................................. 15
4. Operation and Display ........................................................................... 17

4.1 Control options ........................................................................................................................................................ 17
4.1.1 Buttons ................................................................................................................................................................................................. 17
4.1.1 Rotary pulse encoder ........................................................................................................................................................................ 18
4.2 Display concept structure ....................................................................................................................................... 18

4.2.1 Display areas ....................................................................................................................................................................................... 18
4.2.2 Display screen ..................................................................................................................................................................................... 19
4.2.3 Info bar ................................................................................................................................................................................................. 19
4.2.4 Numeric field / Alarm limits ............................................................................................................................................................. 20
4.2.5 Graphic field ........................................................................................................................................................................................ 21
4.2.6 LED Indicators ..................................................................................................................................................................................... 22
4.3 Ventilation Menu ...................................................................................................................................................... 23

4.3.1 Operation – General .......................................................................................................................................................................... 23
4.3.2 Operation – Settings - ....................................................................................................................................................................... 24
fabian HFOi | SW 3.4 3 / 99

4.3.3 Ventilation parameter dependency .............................................................................................................................................. 25
4.3.4 Locking ventilator parameters........................................................................................................................................................ 25
4.4 Graphics Menu.......................................................................................................................................................... 26

4.4.1 Curves ................................................................................................................................................................................................... 27
4.4.2 Loops .................................................................................................................................................................................................... 28
4.4.3 Trend Menu ......................................................................................................................................................................................... 29
5. Preparing for Operation ........................................................................ 31

5.1 Establish Power Supply........................................................................................................................................... 31
5.2 Establish Gas Supply ............................................................................................................................................... 31
5.3 Connect tube set ...................................................................................................................................................... 32
5.4 Patient circuit assembly .......................................................................................................................................... 33

5.4.1 Connect NO tube set and flow sensor........................................................................................................................................... 33
5.4.2 Patient circuit assembly ................................................................................................................................................................... 34
5.4.3 Recommended positioning of temperature probe of humidifier ........................................................................................... 35
5.4.4 Use of reusable patient circuit ........................................................................................................................................................ 36
5.5 Connect nCPAP Tubing ........................................................................................................................................... 37
5.6 Switching On the device.......................................................................................................................................... 38
5.7 Switching Off the device.......................................................................................................................................... 38
6. Device Check fabian HFOi ...................................................................... 39
7. Configurations Menu ............................................................................. 40

7.1 Calibration ................................................................................................................................................................ 41
7.1.1 Flow Sensor Calibration ................................................................................................................................................................... 42
7.1.2 O2 Sensor.............................................................................................................................................................................................. 43
7.2 Display ....................................................................................................................................................................... 44

7.2.1 Touch Screen Settings ...................................................................................................................................................................... 44
7.2.2 Trend / Graph Display ....................................................................................................................................................................... 45
7.3 Ventilation parameter settings............................................................................................................................... 46

7.3.1 Standard Hospital Settings.............................................................................................................................................................. 48
7.4 Patient Data .............................................................................................................................................................. 48
7.5 Language................................................................................................................................................................... 49
7.6 Date / Time ............................................................................................................................................................... 49
7.7 Tools ......................................................................................................................................................................... 50
7.8 Info ......................................................................................................................................................................... 50

7.9 Service Mode ............................................................................................................................................................ 51
8. Alarm Limits Menu ................................................................................ 52

8.1 Automatic Alarm Limits ........................................................................................................................................... 54
8.1.1 Alarm Conditions ............................................................................................................................................................................... 54
8.1.2 Automatic Alarm Presets.................................................................................................................................................................. 54
8.2 Alarm Log .................................................................................................................................................................. 55
8.3 Nurse call relay ......................................................................................................................................................... 55
9. Battery Operation ................................................................................. 56

9.1 Power Failure ............................................................................................................................................................ 57
9.2 Operating on External Power Source .................................................................................................................... 57
10. Function Fields – Ventilation Parameters .............................................. 58

10.1 Special Parameters in HFO Mode ........................................................................................................................ 61
11. Ventilation Modes ................................................................................. 62

11.1 IPPV ......................................................................................................................................................................... 63
11.2 SIPPV........................................................................................................................................................................ 63
11.3 SIMV ......................................................................................................................................................................... 64
11.4 SIMV + PSV ............................................................................................................................................................... 65
11.5 PSV ......................................................................................................................................................................... 66
11.6 CPAP ........................................................................................................................................................................ 66
11.7 nCPAP / duoPAP .................................................................................................................................................... 67
11.8 O2 Therapy mode (High and Low flow oxygen therapy) HFNC ........................................................................ 67
11.9 HFO ......................................................................................................................................................................... 68

11.9.1 HFO Lung Recruitment ................................................................................................................................................................... 68
11.9.2 Special HFO Mode Information .................................................................................................................................................... 68
11.10 Ventilation Additives............................................................................................................................................ 69

11.10.1 Volume limit .................................................................................................................................................................................... 69
11.10.2 Volume guarantee ......................................................................................................................................................................... 69
11.11 Special Functions ................................................................................................................................................ 70

11.11.1 Manual inspiration ( man. Breath) ............................................................................................................................................. 70
11.11.2 O2 Flush / Preoxygenation ........................................................................................................................................................... 70
11.11.3 Standby – stopping / pausing mechanical ventilation ......................................................................................................... 70

12. Error – Cause – Solution – Alarms .......................................................... 71
12.1 Technical Alarm ..................................................................................................................................................... 71
12.2 Physiological Alarm ............................................................................................................................................... 73
12.3 Other Alarm............................................................................................................................................................. 74
13. Replacing the Oxygen Sensor ................................................................ 75
14. Service and Maintenance Intervals ........................................................ 76
15. Sterilisation/Cleaning/Disinfection ....................................................... 77
16. Setting Ranges and Parameters ............................................................ 78
17. Standard Accessories ............................................................................ 82
18. Guide to Volume Guarantee................................................................... 83

18.1 How Does Volume Guarantee (VG) on fabian Work?......................................................................................... 83
18.2 Settings to start with ............................................................................................................................................. 84
18.3 How to start VG function ....................................................................................................................................... 84
18.4 Setting up the ventilator PSV+VG......................................................................................................................... 87
19. Special Procedures................................................................................ 88

19.1 Use of closed suction systems ............................................................................................................................. 88
20. Technical Specifications ........................................................................ 89

20.1 Ambient Conditions ............................................................................................................................................... 89
20.2 Monitoring............................................................................................................................................................... 89
20.3 Measuring................................................................................................................................................................ 90
20.4 Resistance Values .................................................................................................................................................. 91
20.5 Parameter Defaults in Configurations Menu ...................................................................................................... 91
20.6 Dimensions / Weight ............................................................................................................................................. 91
20.7 Ratings ..................................................................................................................................................................... 92
20.8 Data storage ........................................................................................................................................................... 92
20.9 Applied Parts .......................................................................................................................................................... 93
20.10 Device Checks....................................................................................................................................................... 93

20.11 Gas blender function ........................................................................................................................................... 94
20.12 Acoustic Energy .................................................................................................................................................... 94
21. Electromagnetic Compatibility Statement ............................................ 95

1. Working with the instructions
1.1 Document Structure
The left side of the page …

… displays explanations, instructions and detailed description on the topic or procedure.
The right side of the page …

… displays the graphic representations, operating elements and displays belonging to the description
and guides the user through any handling steps.
These instructions for use describe equipment components and their operation. It is laid out such that
you can step by step become familiar with operation of the ventilator.
Please carefully read the instructions for use before using the ventilator.
Once you are familiar with the basic construction and operation of the ventilator you may use the
instructions for use as a reference.
The table of contents will assist you in quickly locating the respective topic.
1.2 Notices and Warnings

This document features 3 categories of notices and warnings.
NOTICES are supplements to instructions
DANGER indicates a not directly imminent but latent hazard which may result in death or
bodily injury unless prevented.
Danger
ATTENTION indicates a risk which may result in equipment damage when not avoided.

1.3 Hardware Version Identification
The hardware version can be identified from the fabian HFO serial number.
Serial number: xxyyxx-nnnn, yy = Hardware version
From the 1st January 2016 the serial numbering has changed to AI-xxxxx
1.4 Symbols
Symbol Description
External power supply input (24V - 5A)
USB connection
Network connection RJ45
Connection for external trigger
Nebulizer Connection
Data input / Data output RS232
Nurse call signal output
Caution, refer to operator’s manual for important safety information and precautions
Flow sensor connection
Potential equalisation connection
Marking per Medical Devices Directive 93/42/EEC
Manufacturer / Date of manufacture
Disposal information
Type B application part

Symbol Description
Unplug power before opening housing
Flammability warning
Warning regarding operation in explosive areas
Dangerous voltage warning
Do not cover
Protect from moisture
Chemical burn warning
Chargen code
Single use
Article No.
non Sterile
Latex free
Fragile, handle with care
Keep away from heat
Keep dry
This way up
Do not use hooks
Do not stack

2. General Notices
2.1 Always Observe
The use of the ventilator requires detailed knowledge and the observation of this
operator’s manual. This device is only intended for the described use.
Only operate the ventilator with accessories recommended by

ACUTRONIC Medical Systems AG.
The ventilator must be operated by qualified technical staff or staff supervised

by such to ensure immediate remedial action in the event of malfunction.
An alternate ventilation method (e.g. Resuscitator) must be available at all times

when using the ventilator.
If the life-support function is no longer warranted due to a noticeable ventilator defect,

the patient must immediately be artificially ventilated using a stand-alone ventilator (e.g.
Resuscitator).
The ventilator may not be used in combination with inflammable gases or narcotic agents
– there is otherwise an acute risk of fire and explosion!
Never use the ventilator in explosive environments!
An audible signal indicates a system or patient alarm and always requires action by a
medical professional.
Never connect the ventilator to patients if an error or malfunction is detected during

equipment check!
Never connect to electrical devices not mentioned in this operator’s manual without first
consulting the manufacturer or an expert.
Never operate the ventilator while covered or set up in a way so as to negatively impact
the operation or function.
Always unplug before opening the housing!
Never use anti-static or electrically conductive tubes.
Note: the safety and health of the users is guaranteed by the fact that the products for
example do not contain any allergenic or mutagenic materials such as phthalates.
The device can only be separated from the main power supply by removing the power
cord completely. Please ensure the power socket is freely accessible at all times for
disconnection. Do not remove the power cable unless for Service purposes or transport.

Warning: modification of this equipment is not allowed.
Note: accessories supplied by Acutronic medical Systems AG for use on fabian ventilators
are biocompatible. Please ensure before applying non-original accessories that they are
biocompatible.
Warning: When connected to a patient do not simultaneously touch the external power
supply and the flow sensor connector cable.
Warning: if the strength of the auditory alarms are less than the ambient sound this might
impede an operator to recognize alarm conditions.
Warning: please ensure that the ventilator is never covered.
Warning: please ensure that the ventilator is never positioned in such a way that the
performance of the ventilator is adversely affected.
Warning: in case of ventilator failure, the lack of immediate access to appropriate

alternative means of ventilation can result in patient death.
Warning: please ensure that Alarms are set appropriately prior to use of ventilator on
patient.
Warning: Do not use the fabian in an oxygen-rich environment
Warning: In case portions of the gas pathways through the VENTILATOR can become
contaminated with body fluids or expired gases during NORMAL CONDITION or SINGLE
FAULT CONDITION, please contact Acutronic Medical Systems.
2.2 Maintenance
This device is a ventilator classified 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 trained experts with access to appropriate test
and measuring equipment.
We strongly recommend ACUTRONIC Medical Systems AG exclusive representatives for service agreements
and repairs.
Only use original ACUTRONIC parts for repairs. Note chapter “Maintenance Intervals”.

2.3 Liability for Functionality / Damages
In the event of improper equipment maintenance or repair by any person not associated with ACUTRONIC
Medical Systems AG Service or improper use, any and all liability for the functionality is transferred to the
owner or operator.
ACUTRONIC Medical Systems AG assumes no liability for damages caused by the non-observance of
preceding notices. The preceding notices do not extend the warranty and liability terms of the ACUTRONIC
Medical Systems AG sales terms and delivery conditions.
2.4 Intended use

The fabian HFOi is intended for premature infants, new-borns as well as children weighing up to 30 kg.
The fabian HFOi is intended for “in-patient use” in hospitals, medically-used rooms and intra-hospital
patient transport.
The fabian HFOi is an electronically microprocessor controlled ventilator.
The fabian HFOi ventilates with excess pressure based on the continuous-flow principle.
(Time cycled, pressure / volume limited or volume guaranteed)
Oxygen is metered by the integrated Air/O2 blender.
The oxygen concentration is measured internally with a galvanic oxygen sensor.
The ventilator is intended for the following ventilation methods:
• HFO High frequency oscillation ( membrane principle )
• IPPV Intermittent Positive Pressure Ventilation (CMV Controlled Mandatory Ventilation)
• SIMV Synchronised Intermittent Mandatory Ventilation
• SIPPV Synchronised Intermittent Positive Pressure Ventilation (A/C, Assist Controlled)
• CPAP Continuous positive airway pressure
• PSV Pressure Support Ventilation
• SIMV + PSV Synchronised Intermittent Mandatory Ventilation combined with PSV
• NIV ventilation nCPAP/duoPAP with variable flow generators
(Infant Flow®, Infant Flow LP®, InspireTM, Medijet®,
• HFNC O2 Therapy, (High and Low flow oxygen therapy)
The equipment is operated by a physician or at his orders by a professional with technical training in this
task, whereupon any user must be trained on this equipment and familiar with the operator’s manual and
the use of the equipment.
fabian HFOii is not approved for use in a homecare environment.
2.5 Scope of Delivery

This product includes the following items:
• 1 x fabian HFOi ventilator ( # 7200 )

• 1 x flow sensor ( reusable ) ( # 1031 )
• 1 x flow sensor cable ( # 1016 )
• 1 x test lung ( # 1116 )
• 1 x Power cable ( # country specific )
• 1 x Operating manual ( # country specific )

2.6 Contra-indications
No contra-indications for the use of the fabian HFOi neonatal and infant ventilator in an intensive care unit
are known.
In the event of ventilation for more than several hours, care must be taken for optimal conditioning of the
respiratory gases (warmth, moisture) to guarantee secretion mobilization and prevent damage to mucous
membranes.
In general, it should be noted with regard to contra-indications that ventilation of children should only be
carried out by clinically trained specialists who have sufficient knowledge of ventilation aof patients of
specified age.
Detailed studies and experience can be requested from the following address:
Fabrik im Schiffli
8816 Hirzel / Switzerland
Tel: +41 44 729 70 80
Fax: +41 44 729 70 81
Email: info@acutronic-medical.ch

3. System overview
3.1 Front Connections
1 Inspiratory tube port/ HFO port
2 Expiratory tube port
3 Pressure measuring tube port
4 External bias flow port and port for nCPAP system based on flow generators (single limb systems)
3.2 Rear Panel
1 Connector for 24VDC (5A) external power supply (no charging!)
2 Network jack for data management , PDMS (To network with minimum 3 KV galvanic isolation)
3 USB port for data output, Software update. Connection for Masimo SpO2 module.

4 RS232 port for PDMS
5 Flow sensor connector
6 Nurse call connector ( max. switching Voltage 50 VDC )
7 Video In , VGA ( option )
8 Loudspeaker
9 Fan
10 CO2 sensor ( option )
11 Nebulizer, ultrasonic ( option )
12 O2 supply connector 2.0 – 6.5 bar / 40 l/min
13 Pressurised air connector 2.0 – 6.5 bar / 40 l/min
14 Power Connector ( fuse 1.25 AT )
15 Pin for potential equalisation
For Adapter to DISS see Accessories.
Warning: Do not connect Ethernet, Nurse call, USB, R232 (CO2), Flow Sensor port to
anything other than specified devices.
The PIN for the Potential Equalisation is there for additional safety and can be connected to an
equipotential zone. Please adhere to local guidelines when using this PIN. The guidelines may vary
between countries, localities and power companies. Always keep the PIN for Potential equalisation
accessible.
Maximum Connected Loads:
Nurse call: Galvanically isolated relay output.

max Load: 30V / 1 A DC or AC
USB: 5V/150mA
RS232: 3.3V/100mA
Flow Sensor: maximum load is one flow sensor.
Only ACUTRONIC flow sensors are allowed to connect.
max. Voltage: 5 V
max operating current: 300 mA per hotwire -> 600 mA total.
Video IN: max voltage: 5 V
max operating current: 300 mA
CO2: max voltage: 5 V
max operating current: 700 mA

4. Operation and Display
4.1 Control options
The control panel features 2 key elements:
1. The display (Touch Screen)
The touch screen allows the direct control of the

ventilator parameters by tapping defined 1
buttons on the graphic user interface.
Access to “quick launch“ settings on the left

side of the touch screen.
2. The key/control panel with rotary pulse

encoder (combines a key and a rotary encoder)
4.1.1 Buttons
The key pad features 2 rows of buttons with various functions.
Manual breath
… used to apply a manual breath. Available in all the ventilation modes. In HFO mode,
it can be disabled in the ventilation menu.
O2 Flush
… used to start O2 flush. Flush concentration and time can be preset.
Menu / Calibration
… used to access the setting and calibration menus. Pressing once will open the
configuration menu; pressing again will open the calibration menu.
Nebuliser
… switches the optional medication nebuliser on and off.
The flow sensor is switched off during medication nebulisation.
Waves / Loops
…switches to ^wave-/loop display.
Home
… displays the main screen for selecting the respiration mode.

Alarm limits
… switches to the alarm limits configuration.
On/Off
… used to switch the device on or off.
Mute alarm
… for acknowledging and muting alarms for a maximum duration of 120 seconds.
Subsequent alarms with higher priority are only displayed optically during muting.
Start/Stop
… used to halt or commence respiration. In ventilation mode, the stop is for 2 minutes,
in nCPAP and DUOPAP mode acts as standby mode.
4.1.1 Rotary pulse encoder
The rotary pulse encoder combines a push button with a rotary encoder for executing
various settings, selections and confirmation options.
4.2 Display concept structure

4.2.1 Display areas
The information system features 2 key display areas
1. The touch screen

2. LED indicators 2
1

4.2.2 Display screen
Shows various information, setting and display fields depending on the display settings or menu
1. Info bar indicating battery status, time/date,

status information, system and alarm
information
2. Numeric field / alarm limits
3. Graphic field (single graph or multigraph
with loops or curves)
4. Function field
5. Operating mode selection
Depending on the display mode selected,
individual fields may be shown/hidden.
Display field options will be described later.
4.2.3 Info bar

The Info bar displays from general information to displaying alarms. It is divided into 3 sections.
The Info bar indicates the following among other things:

1. Neonatal or paediatric mode
Patient data available
Manual breath in HFO mode ON/OFF
Nurse call active / inactive Battery charge status
2. Ventilation mode, info and alarm display
3. Mute alarm (time remaining until alarm reactivates)
Time / date
Paediatric mode. For patients above

10kg bodyweight, use of paediatric mode is
recommended. Extended range for settings.
Neonatal mode. Used for patients up to approx. 10kg

bodyweight.
The patient symbol indicates patient data associated with

the current ventilator operation is saved to the device.
Displays ventilation mode and, if applicable, additional

current information or notices. A red blinking info bar
alerts the user to active alarms.
If screen lock is in use, the symbol for locked screen is
displayed.

4.2.4 Numeric field / Alarm limits
… in the numeric field all measured values are
displayed together with the set limits relevant
in the selected Ventilation mode.
There can be multiple pages of numeric fields.

To go to the next page, press the button below
the numeric field.
Depending on the Ventilation mode the data

is updated as average/minute or by breath.
Numeric field
The upper and lower limits can be manually or
automatically adjusted in the alarm limits menu.
To adjust the alarm limit manually:

• press the alarm limits button
• touch the parameter you wish to change
• the button turns from dark blue to green
• with rotary pulse encoder, change the value
• to confirm the setting, either touch
parameter button again, or push rotary
pulse encoder again.
To automatically set the alarm limits, select

parameter and touch AUTOSET button.
Alarm limits

4.2.5 Graphic field
The button waves/loops changes the screen
… displays the current pressure-, volume- or flow

measurements as a diagram. Use “Waves/loops”
to access the graphics menu.
Three waveforms are displayed simultaneously
Display with 3 curves
You may also switch to loop display view.
In this view two loops and one of 3 waves

are displayed.
LOOP display:
• Pressure / Volume
• Volume / Flow

4.2.6 LED Indicators
The LED Indicators
Warning LED
This LED will light or blink red when a system alarm
is triggered.
Battery LED
This LED will light yellow in battery operation and
green when the battery is fully charged.
The LED will blink green when the battery is
charging.
Mains LED
This LED will light green in mains operation, and
will switch off in battery operation.
When powered via the external 24 VDC connector the mains and battery LED
will not light up.

4.3 Ventilation Menu
4.3.1 Operation – General
Push buttons and their statuses are indicated
by various colours:
1 light blue: Push button
2 dark blue: focused push button
3 yellow (in functions menu): parameters metered
4 green: selected push button, if the push button

features a parameter for setting a value it may
now be changed.
5 orange: parameter is automatically adjusted

by fabian HFOi.
The value set by the user indicates the maximum

value and will not be exceeded.
Depending on the Ventilation mode, the respiration

menu indicates the configuration parameters (4)
and measurements (2) relevant in the mode.
Using the push button you may also switch

between the pressure-, volume- and flow curve (3).
The Info bar (1) indicates current information.
The Ventilation mode may be changed in the menu

(5).

4.3.2 Operation – Settings -
The ventilation parameters may be set before
starting/activating ventilation mode:
1 Desired ventilation mode tap 1x: key will turn

yellow
2 The configuration parameters for the preselected

ventilation mode may now be adjusted
3 Tap ventilation mode again: key will turn green,

ventilation will start with the parameter settings.
The selected parameter may also be confirmed by
pressing the rotary encoder.
If the setting is active (yellow button) and no action

is taken for 15 seconds, or the preselected mode is
not confirmed by tapping again, the device will
continue in the previous mode, any settings are
deleted.
After confirming a parameter the audible alarm is automatically suppressed for 15 seconds.
The audible alarm may be immediately activated by pressing the Mute Alarm key.
Press any blank area or another parameter to not accept the parameter and keep
the previous value
Alternating alarms active at the time the mode is switched will automatically be reset.

4.3.3 Ventilation parameter dependency
If parameters are mutually regulating, an arrow will
appear on the parameter requiring modification
indication the required direction.
List of dependencies:
• O2 Flush min. 2 Vol.% above O2 setting, max. 100 Vol.%
• P insp min. 2 mbar above PEEP
• Ppsv min. 2 mbar above PEEP
• Pmax min. 2 mbar above PEEP
• Pduo min. 2 mbar above PEEP
• P manual min. 2 mbar above CPAP
• Ppsv ≤ Pinsp
• Rise-Time ≤ I-Time
4.3.4 Locking ventilator parameters

Some ventilator parameters are “locked” to
prevent unusual high values. When this value is
reached a key symbol will appear and a notice
signal will sound. The high value must be
confirmed by pressing the rotary knob again. (see
table below)
List of locked values

Parameter Neonatal Pediatrics
I:E Ratio I:E>1 I:E>1
HFO V guarantee > 30
HFO Pmean > 20 > 20
HFO amplitude > 40 > 40
HFO Pmanual > 25 > 25
PInsp > 25 > 25
CPAP > 10 > 10
PEEP <2 <2
PEEP > 10 > 10
V guarantee > 30 > 30
V limit > 30 > 30

4.4 Graphics Menu
The graphics menu may be accessed via the curve key on the keypad.
The following graphics are available in the graphics

menu:
1. Curves
Curves
2. Loops
Loops
Trends will be loaded
when pressing the trends key
3. Trends
Trends

4.4.1 Curves
The curves menu shows the following curves:
• Pressure
• Flow
• Volume
When auto-scaling of graphics is switched off the

graph may be adjusted manually:
1. Select desired graph

2. Tap graph
3. The selected graph is marked with the cursor
symbol and the scaling cursor is displayed
4. Use the cursor to scale the graph in the X and Y
direction.
The cursor disappears if not used within 5 seconds,

or by tapping the selected graph again.
The key “Freeze” stops curve being updated.
The configuration parameters and measurements

in the display field continue being updated.
The key will turn green.
Press the key again to continue updating the curve

data.
Depending on the Ventilation mode selected,

the graphics menu will display the configuration
parameters and measurements relevant in this
mode

4.4.2 Loops
The loops menu features the following loops:
• Pressure / Volume (P/V Loop)
• Volume / Flow (V/F Loop)
The following parameters for the respective curve

may be selected in the upper area of the display:
• Pressure
• Volume
• Flow
The “Freeze” key is used to pause loop updating.
The settings parameters and measurements in the

display field will only be shown once a loop has
been saved.
The key will be displayed green.
Press the key again to continue updating the loop

data.
After “freezing” the loop can be saved to later

compare it against reference loop.
Save loop:
1. Freeze loop
2. Push “Freeze” key
3. The loop will be saved until a new loop
is saved.
Comparing loops:
1 Switch to loops display:
2 Freeze current loop.
3 Current loop is shown in blue,
the saved loop black.

4.4.3 Trend Menu
The fabian HFOi trending function automatically saves an average of measurements every 30 seconds.
Measurements of up to 5 days can be recorded.
Trend data is automatically deleted in the following cases:
• Date and / or time is modified
• New patient data is entered
• Software update
A confirmation message will always be displayed before trend data is deleted.
3
1
2
5 6 7
1. Parameter / selection
2. Graphics
3. Parameter values
4. Timeline
5. Adjust timeline (max. 5 days – min. 30 minutes)
6. Shift timeline
7. Update data (refresh)

Trend Menu
1. Press Curves / loops (1) key
2. Press Trends key
3. Loading trend data Loading trend data
The trend menu features 3 simultaneous

parameters as curves
The parameters displayed can be modified by
activating the Select list on left side.
Available parameters are:
• Pinsp. Pmean
• Fi O2 Vte
• Compliance DCO2
• MV HF Amplitude
Shifting the timeline.
The timeline can be shift for all 3 parameters

simultaneously.
1. Change timeline via rotary pulse encoder or

keyboard

5. Preparing for Operation
5.1 Establish Power Supply
Connect the fabian with power cable to a suitable power socket.
Do not connect the device to a power outlet strip.

Exception: the power outlet strip has been expressly approved by the manufacturer for connection to a
ventilator.
The device can be operated with 100 VAC to 240 VAC and automatically adjusts to particular voltage without
manual switch-over being necessary.
The fuses used must correspond with the value and type approved for the fabian.
The particular fuse type and value is printed on the back of the fabian.
Replacement of the fuses may only be carried out by trained staff. Please replace fuses with
identical values, failing to do so, might cause fire hazards.
WARNING: To avoid risk of electric shock, this equipment must only be connected to a
mains supply with protective earth.
5.2 Establish Gas Supply

Connect the compressed air and oxygen supply tube to the back of the device and to the central gas supply.
If there is no central gas supply, gas supply from cylinders is also possible.
The inputs are coded to prevent wrong connection.
Input pressure 2 – 6 bar, dust-free, oil-free and dry.

5.3 Connect tube set
Never use anti-static or electrically conductive tubes.
The pressure gradient on the Ventilation system of the ventilator measured on the patient
connection port may increase when accessories or other components are attached to the
Ventilation system.
1. Connect inspiratory tube to Insp. port.

2. Connect expiratory tube to Exp. port.
3. Connect pressure measuring tube to Prox.
port.
4. Use FG connection when connecting to an
INoVent Flowsensor.
Always hold tubes by the collar when connecting

and disconnecting to prevent damage.
The expiration membrane can be easily removed

by turning the membrane holder anticlockwise.
Pay attention to the correct installation position of

the expiration membrane
The labelling
TOP
must be legible upon installation. See Illustration.

5.4 Patient circuit assembly
5.4.1 Connect NO tube set and flow sensor
Connect tube „art. No. 7067“ with the NO Flowsensor. Place the NO flow sensor on top of
the water chamber of the humidifier with a T-piece connector in between. Select in Quick
Launch external Bias Flow. With this setting will only come from the FG port, and will
halted at the Insp. Port.
Bias Flow intern: Use when there is no external NO flow sensor.

Bias Flow extern: Use an NO needs to measure the bias flow with an external flow
sensor.
1. Select the Bias Flow Extern.
2. A warning message appears Select the Confirm Box to switch to external bias flow.
When switching between HFO to a Conventional Ventilation Mode one can leave the external NO flow
sensor in this position.

5.4.2 Patient circuit assembly
We recommend the use of single patient circuits to be used on the fabian HFOi. Best performance is
achieved with dual limb heated systems.
Please refer to following diagram for setup:

• Connect fresh gas outlet of ventilator (Insp) with inlet of water chamber
• Connect Inspiratory hose with chamber outlet
• Plug proximal pressure line into port and other end with proximal pressure port on ventilator marked
(Prox)
• Connect the inspiratory- and expiratory tube heater connector with corresponding connector on humidifier
base.
• Connect expiratory hose with exhalation valve

5.4.3 Recommended positioning of temperature probe of humidifier
One of the major sources of problems in neonatal ventilation is, that excessive rainout is affecting accuracy
of flow measurement and therefore compromising its use in various modes of ventilation. It is recommended
to carefully follow the instructions of use of the manufacturer of the humidifier to minimize the risk of rainout
in the patient circuit.
If baby is positioned in incubator, the following setup is recommended:
Place temperature probe outside the incubator and use incubator extension line.
If baby is in open warmer unit, the following setup shall be used:

5.4.4 Use of reusable patient circuit
If reusable patient circuits are used, they preferably shall be with in- and expiratory tube heater wire or
alternatively, a water trap in the expiratory hose:
Assemble the tubing as required:

Connect in-/expiratory tubes and pressure tube to
Y-piece.
Connect flow-sensor to Y-piece
Connect flow-sensor cable to flow-sensor
1 Ventilation tubes
2 Y-piece
3 Flow sensor
4 Flow sensor connection cable
5 Proximal pressure measurement tube
Prepare humidifier according to manufacturer specifications and connect to tubing.
If the humidifier does not feature an inspiratory tube heater, water traps must be installed in the
inspiratory and expiratory tubes.
When using an inspiratory heater a water trap must be installed at the expiratory end.
Be sure the flow-sensor is not exposed to excessive humidification.
We strongly suggest using an inspiratory and expiratory heated tube system in HFO mode.

5.5 Connect nCPAP Tubing
Preparing the nCPAP tubing system
• Connect nCPAP adapter to the fabian

nCPAP port. (Item no.: 7057)
• Connect 22 mm adapter connector to
humidifier chamber.
• Connect nCPAP system pressure measuring
tube to fabian port marked prox.
• Connect nCPAP system to humidifier
chamber.
• Apply nCPAP system to patient per
manufacturer specifications.
For details of using nCPAP systems, refer to the operators manual of the supplier of the consumables.

5.6 Switching On the device
Use the ON / OFF button (1) on fabian HFOi
to power on the equipment.
When the device is powered on the start-up screen

will appear and the equipment will perform a self-
test.
The SOFTWARE REVISION, the CHECK SUMS and

the status of the interfaces will be checked.
(ok ≙ no error)
Once the system test has completed the Calibration

menu will appear.
Now, flow sensor calibration must be performed
Please select the appropriate flow sensor (neonatal
or paediatric).
The O2 will automatically be calibrated after leaving
the calibration menu.
EtCO2 and SpO2 modules can be switched on here

as well. For more information on both modules
please refer to the “fabian HFO CO2 manual” and
the “fabian HFO SpO2 Manual”.
All audible alarms are silenced for 2 Minutes
5.7 Switching Off the device

Disconnect patient.
Use the ON/OFF button (1) on fabian HFOi to

switching off the device.
Hold ON/OFF button until the equipment is

switched off.
Once the device has powered off a notice

tone will sound.
Press the “Mute Alarm” button to confirm system

switch off.
Hold the button for at least 3 seconds
until the WARNING LED stops.

6. Device Check fabian HFOi
Always perform an equipment check before each ventilator use!
What How Target
Gas supply Attach high pressure air and oxygen Air and oxygen supply hoses are correctly
supply hoses on the rear side of the connected
ventilator. Connect with corresponding
wall outlets.
Breathing Membrane holder and membrane Membrane holder and membrane

system Tubes correctly installed.
Water traps (if needed)
Respiratory Humidifier and tube heating Patient circuit assembled correctly as per
Flow sensor manufacturer’s instructions
Connect test lung
Switch on switch on fabian Self-test successful

test Alarm tone (loudspeaker) Alarm tone audible during switch-on test.
Calibration Calibrate flow sensor Calibration successful

Calibrate O2 sensor (occurs automatically
after leaving calibration menu)
Leakage test Start CPAP mode Pressure of 80 ± 4 mbar is achieved

CPAP 5 mbar
P manual 80 mbar
Press button manual insp.
Function test Ventilation mode: IPPV Ventilation occurs with the set frequency.
• I - flow: 10 l/min • P insp.: 20 ±2 mbar
• E - flow: 8 l/min • PEEP: 5 ±1 mbar
• PEEP: 5 mbar • O2: 30 ±2 vol.%
• Pinsp: 20 mbar
• Frequency: 30 1/ min
• I-time: 1 sec
• Oxygen: 30 vol.%
Alarms Kink inspiration tube. Alarm: Tube Occlusion
Kink expiration tube. Alarm: Tube Occlusion
Kink proximal measurement tube Alarm: Tube Occlusion
Humidifier Fill level Water fill level sufficient.

Function Function OK

7. Configurations Menu
The configuration menu can be accessed by pressing the Menu / Calibration key on the keypad
and selected the push button “Open menu”.
1. Calibration 7. Tools
2. Display 8. Info
3. Ventilation 9. Video ( optional )
4. Patient Data 10. PDMS ( optional )
5. Language 11. Service Mode
6. Data / Time 12. Close menu (return to previous menu)

7.1 Calibration
The calibration menu can be accessed through the calibration button in the configurations menu.
The calibration menu can also be accessed via the calibration key.
Finally, upon ventilator start-up it you will be automatically directed to the calibration menu.
The calibration menu can be seen below.
From the calibration screen, one can calibrate the following sensors:
• Flow sensors: neonatal and pediatric
• O2 sensor
• etCO2 module
• SpO2 Module

7.1.1 Flow Sensor Calibration
Flow sensors can be calibrated in the upper half in the calibration menu.
To calibrate a neonatal flow sensor please select the neonatal button.
To calibrate a pediatric flow sensor please select the pediatric button.
For both types of flow sensors the calibration procedure is identical and described below.
Ensure no gas will flow through the flow sensor
during calibration.
To do so the sensor may be held occluding either
one or both ends with a sterile glove.
Press Flow-Cal button
IF the ventilator is in a trigger function mode, the

function will be deactivated during calibration and
respiration will continue in IPPV mode.
First “Checking” will appear, then “Calibration
running”.
The lines in the diagram (see on the right) will move
from left to right, until they are centered in this
diagram. When centered these lines will turn green.
Following successful calibration, the date of the last
calibration will be displayed in the corresponding
field.
The flow sensor calibration needs to be performed each time a new sensor is put in place.
Sensor calibration remains valid, even if unit is switched off and after restart of it.
We recommend cleaning flow sensor once per day.

7.1.2 O2 Sensor
The O2 sensor cailbration can be accessed in the configurations menu, by pushing the O2 button.
The O2 sensor is automatically calibrated when machine starts up and every 24 hours when
in use.
During calibration procedure, the FiO2 concentration of the fresh gas to patient is not
altered.
In case of a supply gas failure, oxygen sensor calibration is disabled automatically to avoid
false sensor calibration
Manual calibration:
Press the “21%” button to perform one point

calibration at 21% O2. Press the “21 + 100%” button
to perform a two point calibration at respectively
21% and 100% O2.
After one of these buttons has been the Calibration

procedure starts. If the procedure has been
successful, a green tick will appear.
Following successful calibration, the date of the last calibration will be displayed in the corresponding field.
Automatic sensor calibration runs every time the equipment restarts and every 24h. The
gas concentration to patient however is not altered during this calibration procedures.
7.1.3 CO2 and SpO2 Modules
For more information on the CO2 and SpO2 configurations please refer to the “fabian HFO CO2 manual” and
“fabian HFOi SpO2 Manual”.

7.2 Display
1. Adjust screen brightness, 4 levels

2. Lock touchscreen. The screen will automatically be unlocked if an alarm is triggered
or the rotary encoder is pressed.
Touchscreen automatically locks after a set time.
3. Display graphs as filled or regular lines.
Auto scale ON / OFF
4. Display trends as filled or regular lines.
Auto scale ON / OFF
7.2.1 Touch Screen Settings

Lock touchscreen
1. Manual
2. After default time
Also locks by holding the rotary encoder for 3

seconds.
Lock is automatically cancelled in the event

of an alarm or by pressing the rotary encoder.

7.2.2 Trend / Graph Display
Auto-scaling graphs: Curve plotting in graphics is automatically
• On adjusted.
• Off
Graphs display:
• Filled
• Not filled
filled
not filled
Auto-scaling trends: Trend patterns are automatically scaled.

• On
• Off
Trends display:
• Filled
• Not filled
filled
not filled

7.3 Ventilation parameter settings
1. Patient range 8. Trigger mode

2. Manual breath HFO 9. E-Flow Parameter settings
3. Tube set nCPAP 10. Alarm delay Pmin (nCPAP/DUOPAP)
4. Pressure unit 11. Ppsv parameter
5. Automatic O2 Calibration 12. Hospital settings
6. Ratio of I-Time 13. Factory defaults
7. Maximum time for manual breath

1. Patient area Before setting of the ventilation parameters can begin, the
(neonatal / pediatric)) appropriate area setting must be selected.
2. Manual breath HFO The manual breath in HFO mode can be used to perform lung
(ON / OFF) recruitment manoeuvre (sustained lung inflation) if clinically
accepted by internal guideline. Length and pressure level
adjustable.
3. Tube set Infant Flow®, Infant Selection of the nCPAP system used.
Flow LP®, Medijet®
4. Unit for pressure Selection of pressure unit.

(mbar / cmH2O)
5. Automatic oxygen
I cases where oxygen supply source does not provide 100%
calibration oxygen, this should be set to 21% only to avoid calibration at false
(21 Vol% / 21 and 100 Vol.%) value.
6. Setting I time or frequency I-time display configuration

(Frequency - I-time / I-time /
E-time)
7. Maximum time for manual Inspiration time for manual breath

breath (2 – 30 sec.)
8. Trigger mode Trigger mode configuration for assisted breathing

(Flow Trigger /
Volume Trigger)
9. E-Flow E-Flow parameter
10. Alarm delay After visual reset of alarm, the reactivation of alarm is delayed for
the set period. Avoids an immediate re-alarm in case of values have
not stabilized yet.
11. Ppsv Parameter Select Ppsv parameter to be absolute value or above PEEP
parameter
12. Hospital settings The “Hospital Settings” button is only active if specific settings were
saved in fabian HFO.( see chapter Hospital settings )
13. Factory defaults Resetting fabian HFO to the factory defaults

7.3.1 Standard Hospital Settings
Only reset to hospital settings if no patients is connected to fabian HFOi.
The “Hospital Settings” button (1) is only active if

specific settings were saved in fabian HFOi.
Access hospital settings from service mode.
This menu is also where the nurse call can be activated and deactivated.
7.4 Patient Data
Entering patient data:
Note:
Entering new patient data will delete all trend data.
1. Reset data
2. Accept
3. Change

7.5 Language
Selecting the user language
Available language option see below

(SW Version ≥ 3.0.1)
• American • French • Japanese • Slovensko

• Chinese • Finnish • Norwegian • Spanish
• Czech • German • Polish • Swedish
• Dutch • Hungarian • Portuguese • Turkish
• English • Italian • Russian
7.6 Date / Time
Changing the data and time:
Once the time or data has been changed the

confirmation tick will change colours.
The new information will be applied once

confirmed.
Note:
Changing the date or time will delete all trend data.

7.7 Tools
Only available with USB stick connected.
Save of:
Trends
Trend data will be output in CSV format.
Log files
Alarm and Error log
7.8 Info
Displays the info screen

(System Information) containing equipment data.

7.9 Service Mode
The service mode is password protected.
Service Modus provides access to hospital settings,

nurse call activation/deactivation, etc.

8. Alarm Limits Menu
1. Automatically sets individual alarm limits.

2. Alarm volume (3 levels)
3. Open log file
4. Display measurements with alarm limits

Accessing the alarm limits menu by pressing the
button: Alarm Limits (1)
The alarm limits menu allows all alarm limits

to manually or automatically be adjusted.
In the event of an alarm a notice will appear in the

info bar and a red bell symbol indicates the alarm
cause.
In addition an audible alarm will sound which may

be silenced for 2 minutes by pressing the mute
button.
The alarm limit can be adjusted manually.
The alarm limits menu automatically focuses

on the corresponding parameter.
The limit may also automatically be adjusted

by pressing Autoset button.
Once the alarm limit has been adjusted or there are no more active alarms, the bell symbol will turn grey.
The visual alarm message must be reset by pressing the “Alarm silence” button.

8.1 Automatic Alarm Limits
8.1.1 Alarm Conditions
Each displayed breath data is checked for violations of the current alarm limits. Additionally the measured
pressure will be checked against the limit every 20 milliseconds with following conditions:
Upper alarm limit of pressure:

- A breath in the range of the upper limit will reset the delay of 5 seconds.
- CPAP: with a delay of 300 milliseconds in case of a manual or mechanic breath -> pressure will be
checked against upper limit, if the pressure is still above the limit after 5 seconds the alarm will be
signaled, otherwise it is cleared
- nCPAP: with a delay of 3000 milliseconds in case of a manual or mechanic breath -> pressure will be
checked against upper limit, if the pressure is still above the limit after 5 seconds the alarm will be
signaled, otherwise it is cleared
Lower alarm limit of pressure:

- A breath in the range of the lower limit will reset the delay set by the user in the ventilation menu
- nCPAP: with a delay of 3000 milliseconds in case of a manual or mechanic breath -> pressure will be
checked against lower limit, if the pressure is still below the limit after the alarm delay set by the user in
the ventilation menu, the alarm will be signaled, otherwise it is cleared
- DUOPAP: pressure will be checked against lower limit, if the pressure is still below the limit after the
alarm delay set by the user in the ventilation menu, the alarm will be signaled, otherwise it is cleared
If an alarm condition has been detected, a dedicated alarm array is written, otherwise it is cleared.
8.1.2 Automatic Alarm Presets

The following alarm limits presets are used as defaults.
• Minute volume upper limit: 180% of measured minute volume
• Minute volume lower limit: 50% of measured minute volume
• Leak upper limit: 150% of measured tube leak up to maximum of 50% tube leak
• BPM (Breath rate) upper limit: 150% of measured breath rate
• APNOE: 10sec
• Proximal pressure upper limit: 5 mbar above set inspiratory pressure
• HFO: Proximal pressure upper limit: 5 mbar above measured inspiratory pressure
• PEEP lower limit: 3 mbar below set exhalatory pressure
• DCO2 upper limit: 150% of measured DCO2 value
• DCO2 lower limit: 50% of measured DCO2 value
• etCO2 upper limit: 150% of measured etCO2 value
• etCO2 lower limit: 50% of measured etCO2 value
• CPAP [CPAP-Mode] upper limit: 5 mbar above set CPAP value
• CPAP [CPAP-Mode] lower limit: 5 mbar below set CPAP value
• CPAP [NCPAP-Mode] upper limit: 5 mbar above set CPAP value
• CPAP [NCPAP-Mode] lower limit: 2 mbar below set CPAP value
• Pduo [DUOPAP-Mode] upper limit: 5 mbar above set Pduo value
• CPAP [DUOPAP-Mode] lower limit: 2 mbar below set CPAP value

8.2 Alarm Log
Switch to alarm limit menu
Press the “Show Log” key to access the alarm

overview
The alarm list is sorted in chronological order.

The parameters shown are:
• Date / Time
• Message
• Priority
(highlighted. See: chapter
Error – Cause – Alarms)
Press the “Hide Log” key to return to the alarm

limits menu.
Switching fabian HFOi off will erase the alarm log.
8.3 Nurse call relay

The delay from the nurse call relay is < 1 second

9. Battery Operation
fabian HFOi features an internal battery.
Battery run time in HFO mode on full charge: approx. 1 hour

Battery run time in conventional mode on full charge: approx. 2.5 hours
These values may vary depending on the parameter settings. The fabian HFOi will continuously calculate the
remaining run time and display it in the info bar. The battery charge is continuously monitored.
The internal NIMH Battery is Maintenance free.
Reduction in battery life on changing operating mode

Automatic shutdown of ventilator!
Changing the operating mode can greatly shorten the operating mode!
• Monitor the remaining battery life when changing the settings!

• Never leave the device and patient unattended during battery operation!
• Establish mains power supply in good time!
In the event of power failure the pneumatic system will automatically open against
atmospheric pressure so that pressure can’t build in the breathing system, allowing
spontaneous patient breathing.
When operating fabian HFOi on the internal battery the HFO amplitude is limited to 60
mbar.
When long term storing please remove the batteries.

9.1 Power Failure
In the event of a power failure fabian HFOi will
automatically switch to battery power without
interruption.
A visual and audible message will be triggered.

Power failure
This message can be confirmed with the Mute

Alarm button.
fabian HFOi will continuously monitor the battery run time.
Additional messages will be triggered at a remaining run time of:

• 15 minutes
• 30 minutes
• 60 minutes, only if the remaining run time is less than 60 minutes during a power failure
If the remaining run time is less than 1 minute a

warning will appear prompting to immediately
switch to a primary power source.
After this point the battery is drained and fabian will

power off.
Battery drained!
– Connect to mains –
– Charge battery after approx. 5 hours –
9.2 Operating on External Power Source

fabian HFOi can also be operated from an external power source.
In this case connect the external 24 Volt power source at the back of the equipment.
Conventional mode: 24 Volt DC, 1 A

HFO mode: 24 Volt DC, 1.5 A
External power connection on the back panel.
NO charging when connected to 24V DC external power supply

NO monitoring of remaining time on external power supply

10. Function Fields – Ventilation Parameters
Ventilation Parameters
Pressure Rise • IPPV I-Flow or Rise Time

Control • SIPPV Will allow for use of either I-flow or Rise time based
• SIMV pressure rise control during inspiration. Pediatric
• SIMV + PSV Mode Only.
• PSV
Rise Time • IPPV Rise Time

• SIPPV Adjustable rise time during inspiration. Pediatric Mode
• SIMV Only.
• SIMV + PSV
• PSV
I-Flow • IPPV Inspiratory flow

• SIPPV Adjustable flow during inspiration
• SIMV
• SIMV + PSV
• PSV
E-Flow • IPPV Expiratory flow (base flow)

• SIPPV The continuous expiratory flow is variable separate
• SIMV from the inspiratory flow.
• SIMV + PSV • Flushing dead space in the Y-piece
• PSV • Maintaining the PEEP
PEEP • IPPV Positive end-expiratory pressure

• SIPPV Pressure inside the lung following inspiration.
• SIMV
• SIMV + PSV
• PSV
Trigger • SIPPV Trigger

• SIMV The trigger sensitivity can be adjusted from level 1 –
• SIMV + PSV 10.
• PSV
This corresponds to 10% - 25% of the exhaled tidal
volume( Vte ) with volume trigger and 0.120 – 2.4 l/min
with flow trigger.
There are 2 trigger functions:

• Volume trigger
• Flow trigger
Which may be selected in the configurations

menu  Ventilation

I-time • IPPV Inspiratory Time

• SIPPV
• SIMV
• SIMV + PSV
• PSV
Freq • IPPV Frequency (Rate)

• SIPPV
• SIMV
• SIMV + PSV
• PSV
P insp. • IPPV Inspiratory pressure

• SIPPV
• SIMV
• SIMV + PSV
P PSV • SIMV + PSV Inspiratory pressure PSV

• PSV Inspiratory pressure during inspiration in PSV mode.
P Backup • PSV Inspiratory pressure

Inspiratory pressure during mandatory inspiration in
PSV mode.
P DUO • duoPAP Upper inspiratory pressure in duoPAP mode.
The lower pressure level is selected in duoPAP mode

via the CPAP parameter.
CPAP • duoPAP Continuous Positive Airway Pressure

• CPAP Continuous flow for producing airway pressure
• nCPAP at the CPAP level
P manual • CPAP Manual Inspiratory pressure

• nCPAP Applying a manual breath
• HFO
Next breath possible after a block period of 200 ms.
O2 • All modes Oxygen concentration

Inspiratory oxygen concentration setting
O2 Flush • All modes Oxygen flush

Perform O2 flush / oxygen spray
(Preoxygenation for max. 2 minutes)
Backup • CPAP Backup Frequency

In the event of apnoea spontaneous breathing is
stimulated after the apnoea duration with a default
number of mechanical breaths.
Flow sensor must be connected and activated.
Backup trigger depends on apnoea period setting.

Volume • IPPV Volume Guarantee/ Volume Limit

Guarantee/ • SIPPV
Volume Limit • SIMV Will allow either volume guarantee or volume limit
• SIMV + PSV to be enabled in the user interface.
• HFO
Vlimit • IPPV Volume limit

• SIPPV Maximum ventilator volume setting.
• SIMV
• SIMV + PSV When the volume limit is reached inspiration is
• PSV stopped.
Pmax • IPPV Max Pressure

• SIPPV Maximum inspiratory pressure during volume
• SIMV guarantee.
• SIMV + PSV
Vguarant • IPPV Volume guarantee

• SIPPV This additional function controls breaths by volume.
• SIMV Changes in the Ventilation system
• SIMV + PSV are compensated.
• HFO This ensures the patient receives a guaranteed volume
with each breath.
In SIMV +PSV, the VG is only applied for SIMV breath
but not for the PSV breath.
Max. time • All modes Maximum time manual breath*

manual breath Maximum duration allowed for manual breaths.
Adjustable from 2 – 30s.
*In Settings menu
Flush Time • All modes Duration of O2 Flush*

Adjustable from 20 – 120s.
*In Settings menu
Termination • SIMV+PSV Termination Criteria PSV*

Criteria PSV • PSV Adjustable from 5 – 35 %.
*In Settings menu

10.1 Special Parameters in HFO Mode
Special Parameters
Flow • HFO Constant flow / bias

Adjustable from 5 – 20 l/min
Default value: 8 l / min
HF amp • HFO High-frequency amplitude

Maximum pressure amplitude. Peak to peak.
P mean • HFO Mean pressure

Continuous positive airway pressure.
I:E • HFO Inspiration to expiration ratio

Adjustable 1:3 / 1:2 / 1:1
HF Freq • HFO High-frequency – frequency

Adjustable 5 – 20 Hz
I-Timerec • HFO Inspiratory time Lung Recruitment*

Adjustable 2-13s.
*Optional.
Freqrec • HFO Frequency Lung Recruitment*

Adjustable 5 – 20 Hz
*Optional.
Pmeanrec • HFO Pmean Lung Recruitment*
*Optional.
AMP max • HFO Maximal Amplitude in Volume Guarantee

11. Ventilation Modes
The ventilator is intended for the following ventilation modes:
• IPPV
Intermittent Positive Pressure Ventilation
• SIPPV
Synchronised Intermittent Positive Pressure Ventilation
• SIMV
Synchronised Intermittent Mandatory Ventilation
• SIMV + PSV
Synchronised Intermittent Mandatory Ventilation with PSV support
• PSV
Pressure Support Ventilation
• CPAP
Continuous positive airway pressure
• NCPAP
NIV mask ventilation (Optional)
• duoPAP
NIV mask ventilation (Optional)
• HFO
High-frequency oscillation (Optional)
• O2 Therapy
High and Low Flow Oxygen Therapy HFNC (Optional)

11.1 IPPV
In IPPV mode (Intermittent Positive Pressure
Ventilation) ventilation is performed at the
specified patterns set on the equipment without
consideration to possible spontaneous patient
respiration. The set rate is the delivered rate.
Set following parameters;

• I-Flow, E-Flow, PEEP, Pinsp,
I-Time, Frequency (Rate)
• Here positive pressure is created during
inspiration with passive expiration.
• This mode should only be used if no
spontaneous breathing from patient
is expected
Function fields and ventilation parameters

Ventilation additives
11.2 SIPPV
Assist Controlled Ventilation (Synchronized
Intermittent Positive Pressure Ventilation) each
spontaneous patient inspiratory effort triggers a
mechanical breath of the ventilator according to
the ventilator parameters set for inspiratory period
and pressure.
The number of breaths per minute supported by

the ventilator is controlled by the patient. In this
mode the patient breathing frequency must be
closely monitored to prevent hyperventilation. Set
the alarm for Frequency high according clinical
guidelines.
Set following parameters:

• I-Flow, E-Flow, PEEP, Pinsp, Trigger
Sensitivity, I-Time, Frequency (Rate)


11.3 SIMV
Breaths triggered by the patient will be displayed in green (default settings).
Ventilation with specified pattern and frequency The synchronisation window for the next
synchronous to the patient’s independent mechanical breath is ½ Te.
breathing.
The patient may spontaneously breathe in between
breaths but receives no pressure support.
For weaning from ventilation.
If apnoea is detected ventilation will commence

with the specified TI and TE frequency.
To prevent auto-triggering another breath cannot

be triggered for 200 ms following a breath.


11.4 SIMV + PSV
In SIMV mode + PSV (Synchronized Intermittent Mandatory Ventilation + Pressure Support Ventilation) the
patient may initiate a PSV breath in between the mandatory SIMV breaths.
The machine breath (SIMV) is synchronised with the patient’s breathing pattern. The amount of mechanical
breath per minute is same as the preset frequency.
If patient stops spontaneous breathing, the ventilator will deliver the amount of mechanical breath set with the
Frequency button.
Every spontaneous inspiratory effort of the patient is supported with the preset Ppsv pressure level. It ends
when flow termination criteria is met.
Each SIMV breath can be triggered by the patient.

Between SIMV breaths the patient is able to trigger a supportive PSV breath. The minimum pressure for
the Ppsv is 2 mbar ( trigger breath ) / 5 mbar ( untriggered breath ) above PEEP.
Maximum PSV level Ppsv = Pinsp
Note: The PSV support is shown as absolute pressure
A triggered breath is coloured green whereas the

non-triggered ones are grey.
The inspiratory pressure for the PSV breath is set using the P psv button.
The PSV breath is terminated at one of the following criteria’s:

• Airway pressure exceeds a pressure setting PPSV
• Inspiratory flow has dropped to 5 - 35 % of the maximum value of inspiratory flow.


11.5 PSV
The Pressure Support Ventilation option is used to support the pressure of insufficient spontaneous breathing in
triggered ventilation modes. The breathing frequency is determined by the spontaneously breathing patient,
whereas the ventilator assumes an adjustable portion of the breathing effort.
Thus inspiration is controlled by the patient, and occurs according to the parameters set in ventilation
type SIMV. However, the ventilator will now control expiration. This will occur when one of the following criteria
is met:
• Airway pressure exceeds a PPSV pressure setting

• Inspiratory flow has dropped to 5 – 35% of the maximum inspiratory flow setting
(indicating a virtually filled lung)
If the patient stops breathing spontaneously the ventilator will assume alternate breathing with the ventilation
parameter settings.
Apnea backup ventilation will start after preset Apnea time. If this is set to OFF, backup starts after E-Time.
The inspiratory pressure for the PSV breath is set using the P insp. button.

11.6 CPAP
In CPAP ventilation the patient breathes spontaneously, the ventilator does not provide breathing. This mode
will merely produce a positive pressure during inspiration and expiration, noticeably reducing the patient’s
breathing effort. The maximum automatic leak compensation is 100% of the inspiratory flow.
In the event of an interruption in the patient’s breathing, following the default apnoea period the ventilator will
perform a default number of mechanical breaths to stimulate spontaneous breathing. Once breathing
commences stimulation will abort and will only commence with the next apnea event.


11.7 nCPAP / duoPAP
In nCPAP / duoPAP mode the patient spontaneously breathes via mask or nasal cannula.
Since no flow sensor is connected, an additional apnoea monitoring method should be used,
e.g. impedance measurement. Additionally monitoring SpO2 and PCO2 is recommended.
nCPAP: Supplies a positive airway pressure with automatic leak compensation.

The maximum flow compensation is 40%.
duoPAP: Same as nCPAP but with the option of positive pressure ventilation with
adjustable frequency and inspiratory period.
This mode requires a special nCPAP patient set with nCPAP generator.
Before using the nCPAP / duoPAP mode the correct system must be specified
in the specifications menu.
The following systems are currently can be used:

• Infant Flow ®
• Infant Flow LP ®
• MediJet ®
• Inspire 

If Insp. time is set lower than 1 sec. the maximum pressure may not be reached.
Depending on the tube set, nCPAP generator and humidifier
11.8 O2 Therapy mode (High and Low flow oxygen therapy) HFNC
O2 Therapy is an option which allows use of a continuous flow of blended gas, from 1 – 19 LPM. Nasal cannulas
of various makes like F&P, Atom or similar can be used. There are no alarm functions active in
this mode, except for the set FiO2
Note:
This mode can also be used to put the ventilator in standby mode. By setting a flow of 4 LPM, the humidifier
dual servo temperature controls remain active, so no need to switch it off in case of short term standby mode.
There are no patient alarms active in this mode.

11.9 HFO
Ventilation with high-frequency pressure oscillations allows a
gas exchange inside the lung despite the very small Tidal
volumes (often on the scale of the dead space volume).
While pressure amplitudes inside the breathing tube system
can be quite significant, only minor fluctuations around the
mean pressure occur inside the lung.
The mechanical strain due to periodic lung expansion and

relaxation is minimal.
High-frequency ventilation about the PEEP/CPAP level as
mean pressure average. The high frequency pulses
superimpose the mean pressure at the set frequency.
11.9.1 HFO Lung Recruitment

Lung Recruitment is an optional setting in HFO.
The Pmean is thereby increased cyclically to an adjustable value “Pmean rec.”
The repetition frequency is selectable from 1 cycle/hour to 4 cycles/minute.
The inspiratory time can be set from 2 sec to 60 sec if the expiratory time is ≥ 2 seconds.
Function fields and ventilation parameters Ventilation additives
11.9.2 Special HFO Mode Information
When operating fabian HFOi via the internal battery HFO amplitude is limited to 60 mbar.
During HFO ventilation the distinct recognition of disconnection and measurement of the
minute volume is limited.
Use of a heated inspiratory and expiratory tubing system is strongly recommended in HFO
mode.


11.10 Ventilation Additives
To optimise ventilation the following additives can be combined with the selected mode.
11.10.1 Volume limit

The volume limit function automatically switches to expiration when the default tidal volume is reached.
Changing the ventilation pattern or adjusting the volume limit the tidal volume is automatically limited.
The display will show the message: “Volume limited”
In the event of flow measurement outage ( e.g. changing the sensor) „V Limit“ will
automatically be deactivated.
Once flow measurement is available again “V Limit” will automatically be reactivated.
11.10.2 Volume guarantee

Volume guarantee is an additional pressure limiting function with controlled or targeted tidal volume
application.
Select the volume to be applied in the “V Guarant” field.

fabian HFOi automatically adjusts the required ventilation pressure Pinsp up to the maximum pressure
“Pmax”. “Pmax” can be set before switching on VG. When the presets are ready, please switch on by pushing
the “Volume guarantee on” button.
Pinsp will be gradually increased breath by breath to achieve preset Vte. The maximum pressure increase
breath by breath is limited to 3 mbar.
If the Pinsp setting is insufficient for applying the targeted volume, the following message is displayed: “Tidal
volume not reached”. An upward arrow in Pinsp field guides user that to achieve preset Vte, the Pinsp must be
increased.
In the event of flow measurement outage ( e.g. changing the sensor) „V Guarant“ will
automatically be deactivated.
Once flow measurement is available again “V Guarant” will automatically be reactivated.

11.11 Special Functions
11.11.1 Manual inspiration ( man. Breath)
In virtually all ventilation modes a manual breath (with the ventilation parameters set in
the current ventilation mode) can be triggered by pressing the “manual inspiration” button
The duration of the manual breath can be set under Configurations Menu -
> Ventilation.
This may last 2-30 seconds, then a termination of the manual breath will
be forced.
The next manual breath is only allowed after a block period of 200 ms.
In HFO mode manual inspiration can be deactivated.

If activated, some clinicians use this for a manual sustained lung inflation after suctioning.
A manual breath however may lead to lung over distension.
11.11.2 O2 Flush / Preoxygenation

Press the “O2 Flush” button to trigger an O2 flush.
Short-term oxygen spray (O2-Flush) with an increased O2 concentration is permissible in

all ventilation modes. This will automatically be ended after a maximum of 2 minutes.
(also see defaults in menu: Configuration -> Ventilation -> Flush Duration)
Press the “O2 Flush” button in a ventilation mode to initiate the O2-Flush.
The flush concentration may now be set with the rotary pulse encoder.
Pressing the O2 button again will end the flush prematurely.
11.11.3 Standby – stopping / pausing mechanical ventilation

The “Start / Stop” button may be used to interrupt mechanical ventilation for 2 minutes.
In nCPAP and duoPAP mode ventilation may be interrupted indefinitely.
In both cases the built-in gas mixer delivers a minimal flow to prevent heat build-up inside
the ventilatory gas moistener.
Ventilation will resume following the 2 minute pause or the button is pressed again.
Risk of oxygen undersupply!

The standby function is not intended for siphoning.
A disconnection or reconnection is not recognised.

12. Error – Cause – Solution – Alarms
Alarms are categories by 3 priority levels; high, medium and low. They differ visually and acoustically according
to priority.
I=HIGH blinking message highlighted red Tone: ♪♪♪-♪♪-♪♪♪-♪♪ 4 sec. pause

II=MEDIUM blinking message highlighted yellow Tone: ♪♪♪ 5 sec. pause
III=LOW message highlighted yellow Tone: ♪ 15 sec. pause
Messages in this table are listed in alphabetical order.

This table is intended to help you determine and resolve the cause of an alarm message.
12.1 Technical Alarm
Description Cause Solution Priority
Air supply pressure Air supply pressure too low. Ensure pressure above 2 bar. I
Blender defect Proportional mixer or Contact Acutronic Service

I
control defective
Charge battery Remaining battery time < Switch to mains supply.

(< 15 min) 15 min. Alarm may be silenced with Mute Alarm.
I
fabian HFOi continues in battery mode
without interruption.
Charge battery Remaining battery time < Switch to mains supply.

(< 30 min) 30 min. Alarm may be silenced with Mute Alarm.
II
Charge battery Power failure. Switch to mains supply.

(< 60 min) Internal battery remaining Alarm may be silenced with Mute Alarm.
II
charge less than 60 fabian HFOi continues in battery mode
minutes. without interruption.
Checksum-ERROR System error Contact Acutronic Service I
COM read/write System error Contact Acutronic Service

I
error
DIO read/write System error Contact Acutronic Service

I
error
Blower defect Fan not moving Contact Acutronic Service I
Flat battery! Remaining battery time < 1 Immediately switch to mains supply
I
min.

Flow sensor defect Damaged heating wires Replace flow sensor.

I
inside flow sensor. Calibrate.
Flow sensor not Flow sensor not connected. Check flow sensor and sensor cable
I
connected Defective sensor cable. connection.
High tube leak Upper alarm limit exceeded Adjust limit value.
II
Inspect tubing system.
I2C read/write error System error Contact Acutronic Service I
Inspiratory Leak. Check tubing system for tight connection.

pressure not Flow too low. Increase flow. III
reached
Low RAM memory System error Contact Acutronic Service I
O2-Sensor Error occurred during Repeat calibration.

I
calibration failed calibration.
O2 value out of O2 sensor or mixer Replace O2 sensor or contact Acutronic

I
range defective. Service.
Oxygen sensor O2 sensor defective. Replace O2 sensor.

I
defect
Oxygen sensor O2 sensor worn. Replace O2 sensor as quickly as possible.

I
used up Calibration still available.
Oxygen supply Oxygen supply pressure too Ensure pressure above 2 bar.
I
pressure low.
PIF read/write error System error Contact Acutronic Service I
Power failure Power failure Switch to mains supply.

Alarm may be silenced with Mute Alarm.
III
Safety relay defect Safety relay defective. Contact Acutronic Service I
SPI read/write error System error Contact Acutronic Service I
Voltage control System error Contact Acutronic Service I

12.2 Physiological Alarm
Apnea Spontaneous patient Switch to controlled ventilation.

I
breathing halted.
High breath rate Hyperventilation Adjust frequency

II
self-trigger Increase trigger threshold
High DCO2 alarm Exceeded upper alarm limit Adjust limit value.
II
Check tubing system.
High minute Lung compliance has Check ventilation settings

volume increased.
II
Resistance has decreased.
Hyperventilation.
Low DCO2 alarm Value below lower alarm Adjust limit value.
II
limit Check tubing system.
Low minute Lung compliance has Check ventilation settings

volume decreased.
Resistance has increased. II
Spontaneous breathing
stops or is declining
Volume limited Upper alarm limit exceeded Adjust settings. II

12.3 Other Alarm
Check ET Tube Tube snapped or clogged. Clear passage. I
Clean flow sensor Water or secretion in flow Clean/replace flow sensor.

I
sensor Calibrate.
High PEEP alarm PEEP 6 mbar above set Check tubing.

value for at least 15 Check patient connection. I
seconds.
Patient Leak or disconnection. Check tubing system for leaks.

I
disconnected Check setting of Pinsp.
Pressure too high Pressure rise in tubing Check tubing system.

system, mechanical Replace patient system.
I
inspiration was reduced to
relieve the system.
Pressure too low Leak or disconnection. Check tubing system for tight connection.
Insp. flow or exp. flow set Increase flow. I
too low.
Tidal volume not Inspiratory pressure default Adjust inspiratory pressure setting.
reached is reached prematurely. Increase inspiratory period. II
Adjust volume setting
Tube occlusion Expiration tube Check ventilation tubes.

I
blocked/kinked
Tube occlusion Inspiration tube Check ventilation tubes.

I
blocked/kinked
Tube occlusion Excessive deviation Check pressure sensor connection

between inspiration and (proximal). I
expiration pressure sensor. Contact Acutronic Service

13. Replacing the Oxygen Sensor
Switch off fabian HFOi and unplug from power supply.
Remove screws (3 x) on fabian housing cover.

Lift off housing cover.
The oxygen sensor is located at the front right inside the

fabian, viewing from the back.
Unplug oxygen sensor cable.

Unscrew oxygen sensor counter-clockwise.
Screw in new sensor and connect sensor cable.
Reinstall housing cover.
Switch on fabian.
Calibrate oxygen sensor at 21 %Vol.
and 100 %Vol.
Used O2 sensors must be properly disposed of. Please note:
Do not force O2 sensor open – risk of chemical burns!
Dispose of O2 sensors in accordance with local waste management regulations (cf. battery disposal).
Please contact local environmental or regulatory agencies and appropriate waste management companies for
information.
When installing a brand new sensor a second calibration can be necessary after about
30 minutes. If possible, expose the new sensor for about 30 minutes to the ambient air
BEFORE installing

14. Service and Maintenance Intervals
Always clean and disinfect equipment or equipment components prior to any maintenance – including when
returning the equipment for repair.
Every 6 months
Perform the following work:

• Clean cooling air filter (casing bottom), replace if necessary
Every 12 months
Maintenance and safety inspections
Perform the following work:

• Device check as specified by manufacturer
• Check alarm and limit value functions
• Check pressure connections
• Check electrical connections
• Check safety shutdown calibration
Replace the following components:

• Air and oxygen Input filter
• Cooling air filter (casing bottom)
• O2 sensor
Every 4 years
Replace the following components:

• Air and oxygen Input filter
• Cooling air filter (casing bottom)
• O2 sensor
• Linear valves pressurised air / oxygen mixer
• Input pressure regulator pressurised air / oxygen
• Calibration valves
• Lithium battery
• Accumulator
• Membrane HFO module
Maintenance and safety inspections must be performed by Acutronic trained experts with
access to suitable testing and measuring equipment.

15. Sterilisation/Cleaning/Disinfection
The device must be prepared after each patient treatment.
Cleaning and disinfection procedures according to country specific regulations
The device may not be sterilized under any circumstances!
Flow Sensor
• Do not clean sensor with compressed air or water jet, as the sensor wires could be destroyed.
• Never treat sensor in automatic cleaning-/disinfection machine.
• Rinse flow sensor element in distilled water.
• Thoroughly shake off residual water.
Steam sterilization at 132°C for 2 minutes (half cycle).
The flow sensor should be changed when it is unable to be calibrated.
Replace and clean sensor once a day. It has been shown that this increases the service life of the sensor.
Never connect an uncalibrated sensor to a patient. Always calibrate the sensor before connecting to a
patient.
Membrane holder with membrane
Clean and disinfect wet thermally (80 - 95°C / 5 min) in the automatic cleaning/disinfection machine just
with detergent. Steam sterilization at 132°C for 2 minutes ( half cycle )
Change the membrane when the unit fails the device check – Function Test. See chapter 6.
In general, sterilize the membrane holder to ensure that residual water in the channels and control cables
dries out.
Ventilation tubes
Preparation according to manufacturer information
Heating wire
Water trap
Temperature probe
Y-piece

16. Setting Ranges and Parameters
Mode IPPV SIPPV
Neonatal Pediatric Neonatal Pediatric
Parameter
min max min max min max min max
I-Flow [l/min] 1 20 2 32 1 20 2 32
E-Flow [l/min] 3 8 4 20 3 8 4 20
Rise Time [s] 0.3 2 0.3 2
I-time [s] 0.1 2 0.3 2 0.1 2 0.3 2
E-time [s] 0.2 30 0.3 30 0.2 30 0.3 30
Frequency[1/min] 2 200 2 100 2 200 2 100
PEEP [mbar] 0 30 0 30 0 30 0 30
Pinsp [mbar] 4 80 4 80 4 80 4 80
Trigger* (Volume) 1 10 1 10
Vlimit [ml] 1 150 10 500 1 150 10 500
Vguarant [ml] 0.8 60 10 300 0.8 60 10 300
Pmax [mbar] 4 80 4 80 4 80 4 80
O2 [%] 21 100 21 100 21 100 21 100
O2 Flush [%] 23 100 23 100 23 100 23 100
Flush Time [s] 30 120 30 120 30 120 30 120
Max. Time Man. Breath [mbar] 2 30 2 30 2 30 2 30
*Flow trigger: 0.120 – 2.4 l/min

Mode SIMV SIMV+PSV
Parameter
I-Flow [l/min] 1 20 2 32 1 20 2 32
E-Flow [l/min] 3 8 4 20 3 8 4 20
Rise Time [s] 0.3 2 0.3 2
I-time [s] 0.1 2 0.3 2 0.1 2 0.3 2
E-time [s] 0.5 30 0.5 30 0.5 30 0.5 30
Frequency [1/min] 2 100 2 100 2 100 2 100
PEEP [mbar] 0 30 0 30 0 30 0 30
Pinsp ( backup )[mbar] 4 80 4 80 4 80 4 80
PPSV [mbar] 2 80 2 80
Trigger 1 10 1 10 1 10 1 10
Vlimit [ml] 1 150 10 500 1 150 10 500
Vguarant [ml] 0.8 60 10 300 1.2 60 10 300
Pmax [mbar] 4 80 4 80 4 80 4 80
O2 [%] 21 100 21 100 21 100 21 100
O2 Flush [%] 23 100 23 100 23 100 23 100
Flush Time [s] 30 120 30 120 30 120 30 120
PSV Termination Criterium [%] 5 35 5 35

Mode PSV CPAP
Parameter
I-Flow [l/min] 1 20 2 32
E-Flow [l/min] 3 8 4 20
I-time [s] 0.3 2
E-time [s] 0.2 30 0.3 30
Frequency [1/min] 2 200 2 100
PEEP [mbar] 0 30 0 30
PBackup [mbar] 4 80 4 80
PPSV [mbar] 2 80 2 80
Trigger 1 10 1 10
Vlimit [ml] 1 150 10 500
Vguarant [ml] 0.8 60 10 300
O2 [%] 21 100 21 100 21 100 21 100
O2 Flush [%] 23 100 23 100 23 100 23 100
Flush Time [s] 30 120 30 120 30 120 30 120
PSV Termination Criterium [%] 5 35 5 35
Flowmin [l/min] 4 16 4 16
CPAP [mbar] 1 30 1 30
Pmanual [mbar] 4 100 4 100
Backup 0 5 0 5

Mode HFO
Neonatal Pediatric
Parameter
min max min max
Vguarant [ml] 0.3 30 10 100
AMPmax [mbar] 5 100 5 100
O2 [%] 21 100 21 100
O2 Flush [%] 23 100 23 100
HFamp [mbar] 5 100 5 100
HFFreq [Hz] 5 20 5 20
Pmean [mbar] 5 50 5 50
I:E 1:3 1:1 1:3 1:1
Flow [l/min] (constant / bias) 5 20 5 20
Freqrec [1/hr] 1 240 1 240
Pmean rec [mbar] 7 50 7 50
I-Timerec [s] 2 60 2 60
Flush Time 30 120 30 120
Max. Time Man. Breath 2 30 2 30
When powering fabian HFO by internal battery HFO amplitude is limited to 60 mbar.
Mode NCPAP DUOPAP O2 Therapy

Neonatal Pediatric Neonatal Pediatric Neonatal Pediatric
Parameters
min max min max min max min max min max min max
I-time [sec] 0.15 15 0.15 15
E-time [sec] 0.2 30 0.2 30
Frequency [1/min] 2 60 2 60
O2 [%] 21 100 21 100 21 100 21 100 21 100 21 100
O2 flush [%] 23 100 23 100 23 100 23 100
Flush Time 30 120 30 120 30 120 30 120 30 120 30 120
Max. Time Man. Breath 2 30 2 30 2 30 2 30
Flowmin [l/min] 0 15 0 19
CPAP [mbar] 2 13 2 13 2 13 2 13
PDUO [mbar] 5 15 5 13

17. Standard Accessories
Item no. Description
7360 Membrane holder, 22mm OD / 15mm ID
7007 Membrane, expiration
7003 Oxygen sensor
1016 Flow sensor connector cable
7058.1 Flow sensor, single use
1031 Flow sensor, reusable
1116 Test lung for neonatal ventilators, with 2 bellows, to simulate

ventilation
Not autoclavable
5191 Adapter NIST – DISS O2
5192 Adapter NIST DISS Air

18. Guide to Volume Guarantee
Mechanical ventilation is required to manage neonates with severe respiratory failure. Pressure-limited
ventilation (PLV), delivering a fixed peak inflating pressure (PIP), has traditionally been used to control the
arterial carbon dioxide (PaCO2). During PLV the tidal volume (VTe) fluctuates widely due to the baby's
breathing, changes in lung mechanics and variable endotracheal tube (ETT) leak. As high VTe (volutrauma),
and not pressure per se, causes lung injury, controlling VTe rather than PIP is a logical strategy for ventilating
preterm infants.
The fabian™ series of Neonatal/Pediatric microprocessor-controlled ventilators allow volume-targeted

ventilation (VTV) even in very preterm infants. Measurements are done with the flow sensor placed at the
Y-piece. The flow sensor measures inspired and expired VT, and ETT leak is calculated and displayed.
The advantage of targeting inspired VTi is that the ventilator controls the VTi as it is delivered. The major
disadvantage is that variable ETT leak alters the delivered VTi. The advantage of using the expired VTe is that
this most accurately reflects the VT that entered the infant's lung, and is less influenced by ETT leaks unless
they are very large.
Volume guarantee (VG) ventilation is a VTV-mode controlling the expired VTe.
18.1 How Does Volume Guarantee (VG) on fabian Work?

The operator sets a target expired VTe (set VTe). The ventilator measures the expired VTe for each inflation and
automatically adjusts the PIP(Ppeak) for the next inflation of the same type, triggered or untriggered, aiming
to deliver the VTe around the set level. The detailed guide how to start VG function on the fabian™ ventilators
is described on the following pages in detail.
The maximum difference in pressure from breath to breath is limited to 3cmH2O to avoid any overdistension
due to excessive pressure compensation.
The main issue is to choose an appropriate VTe at the start and to give enough pressure to get it in. The
following procedure describes the use of VG in SIPPV(A/C) mode, however, the same procedure can be
followed in the other modes where VG function is available. IPPV, SIPPV, SIMV+PSV and PSV.
Look at what VTe the baby is currently getting on his current ventilation settings. You can get this value from
the measured parameters displayed on the right side of the display.
The usual VTe to aim for is 4-6ml/kg per breath. Starting with 5ml/kg is usually a safe point but may be a bit
high for some babies.
Look at the pressure settings. The pressure settings are - in essence - alarm settings. If the ventilator cannot
deliver the VTe at the pressures prescribed, it will alarm "Tidal Volume not reached". You may need to
increase the PIP(Pinsp) to stop it from alarming.
The rate setting is a "back-up" rate if the baby is not breathing. However, it should be set 10-15 breaths below
the baby's apparent rate so that the baby has an opportunity to trigger.
If VG is added to the SIPPV, each breath is maintained at same exhaled tidal volume. In case of an
improvement of lung compliance, the Pinsp is automatically reduced
Every single inspiratory effort of the patient is supported with a mechanical breath with fixed inspiratory time
and fixed Inspiratory Pressure. If the breath was triggered by patient, it is colored green, if none triggered,
grey. The baby controls the rate of ventilation.

18.2 Settings to start with
I-Flow 8 LPM
E-Flow 6 LPM
Rate between 35 and 40 BPM
Inspiratory time between 0.3s and 0.4s
Pinsp between 16 and 18cmH2O
PEEP 4 - 6 cmH2O
18.3 How to start VG function

Step 1
Setup ventilator in SIPPV and start ventilation
Step 2
Please select the appropriate Vte to be guaranteed.
Important: To ensure the VG function works appropriately, a small plateau in the tidal volume wave needs
to be present.

Step 3
Please set in the Pmax field the maximal pressure value to which the VG function is allowed to regulate.
Triggered and non-triggered breaths are independently supported based on lung compliance. Normally,
a triggered breath has a lower Pinsp than a non-triggered one due to different lung compliance.
Step 4
VG can now be activated by selecting the “ON/OFF” button. When VG function is on this button will
turn green. Furthermore a red line will appear in the pressure wave diagram to marks the Pmax.

Note:
If the targeted volume cannot be reached with the set Pmax the warning: “Vte not reach, check settings”
will appear. An upward pointing arrow will appear in the “Pmax” field to indicate the maximum pressure
has been reached.
In case the flow sensor is deactivated, the VG will be shut off and the pre-set Pinsp will be used to ventilate.

18.4 Setting up the ventilator PSV+VG
If Volume Guarantee is added to PSV, the ventilator automatically is adjusting the PPSV level necessary to
maintain preset target volume. In case of an apnea, the ventilator will start cycling at preset rate and PBackup.
As soon as spontaneous activity restarts, the backup stops.
Settings to start with

I-Flow 8 LPM
E-Flow 8 LPM
Rate between 30 to 40 BPM - Safety backup rate in case of apnea
Inspiratory time between 0.3s and 0.4s - Used for backup and as max I-Time
Pbackup between 16 – 18cmH2O used during apnea backup ventilation
PBackup PPSV 16 – 18 cmH2O
PEEP 4 - 6 cmH2O
The minimum pressure difference between PEEP and PPSV is always 2 cmH2O and PPSV is max same level as Pinsp.
PSV breaths as well as apnea backup breaths are volume targeted breath in this mode.
The delay to start backup ventilation is set with the Apnea time in alarm limit screen.
If Apnea is set to OFF > backup starts after E-Time
In PSV+VG mode, the patient controls the onset of inspiration as well as the end of inspiration, offering a
total synchrony with patients breathing pattern.
If patient lung compliance is improving, the ventilator automatically is using the lowest pressure, necessary
to maintain the preset target volume.
In case of a respiratory fatigue and a ceasing inspiratory effort, the ventilator automatically will provide an
apnea backup ventilation with the preset parameters for I-Time, Frequency and Pbackup.
The delay for the onset of the apnea backup ventilation is set in the alarm screen, by setting the apnea delay
time. If set to OFF, the ventilator will start apnea backup ventilation immediately after E-Time, otherwise
after preset apnea time.
It is recommended to use a delay time to avoid the ventilator to kick in unnecessarily and interfering with
patients breathing pattern.
The apnea backup breaths are Volume guaranteed breaths.

19. Special Procedures
19.1 Use of closed suction systems
Suction can be done in the following ventilation modes:
HFO
IPPV
SIPPV
SIMV
SIMV+PSV
PSV
CPAP
The suction catheter system has to be placed between the flow sensor and the patient. See picture
1. Tube set coming from the fabian +nCPAP evolution

2. Flow sensor has to be placed on the device side of the suction system
3. Closed Suction System
4. Patient side
Before suction do a preoxygenation of the patient
Choose the right catheter for the suction. Otherwise, a too high vacuum is possible!
Silence the alarms before suction (2 minutes) for not disturbing the suctioning. After the suction reactivate
the alarm again.

20. Technical Specifications
20.1 Ambient Conditions
During Operation Transport Storage
Ambient min max min max min max
+10 C
o
+40 C
o
-20 C
o
+60 Co
0C
o
+40oC
Temperature
+50oF +104oF -4oF +140oF +32oF +104oF
Air Pressure 700hPa 1060hPa 500hPa 1060hPa 700hPa 1060hPa
Relative Humidity
10% 90% 10% 90% 20% 80%
Non condensing
The minimum and maximum ambient temperatures in the clinical area will not affect the accuracy of the
flow, pressure or oxygen measurement.
Depending to the accessories the environmental conditions can be different. Note Related Manuals.
20.2 Monitoring
Acoustic pressure of alarm tones. Alarm tone sequence IEC:
High priority: 49 db(A) – 65 db(A)
Medium priority: 49 db(A) – 63 db(A)
Low priority: 48 db(A) – 63 db(A)
A weighted sound pressure level in 1m distance : 46dB
Expiratory minute volume

Alarm lower threshold value: If lower alarm limit undershot
Alarm upper threshold value: If upper alarm limit exceeded
Airway pressure
Alarm lower threshold value: If lower alarm limit undershot
Alarm upper threshold value: If upper alarm limit exceeded
maximum airway pressure: 100 mbar
Inspiratory O2 concentration
Alarm: Set value ± 5 Vol.% for > 1 minute at 21 Vol% below threshold value 18 Vol%
Breath frequency
Alarm: If alarm limit exceeded
Volume monitoring
Alarm lower threshold value: If the breath volume set was not supplied
Apnoea alarm
Alarm: If no breathing activity is recognized

20.3 Measuring
Airway measurement Range: -60 – 130 mbar
Precision: ± 4%
Resolution: 0.1 – 1 mbar
Breath volume measurement range: 0 – 9.99 l ( BTPS ) (inspiratory and expiratory)

Precision: ± 8%
Resolution: 0.1 – 100 ml
Volume Controlled Breaths:

Max. bias error: 0.5 ml
Max. linearity error: 10% (1ml at 10ml)
Max. error delivered vs. set volume: 0.5 ml at 1ml, 1 ml at 10 ml, 8 ml at 100 ml
Max. error in delivered vs set PEEP: 0.5 mbar < 10 mbar, 1 mbar > 10 mbar
Pressure Controlled Breaths:

Max. bias error: 0.5 mbar
Max. linearity error: 3%
Max. error of airway pressure (Paw): 1 mbar or 3%
Max. error in delivered vs set PEEP: 0.5 mbar < 10 mbar, 1 mbar > 10 mbar
Inspiratory Oxygen Concentration:

Max. error delivered vs. set FiO2: 3% FiO2.
Response time to change in FiO2: Conventional Ventilation: blender delay is 1 breath.
HFO mode: blender delay is 500ms.
Total Delay = Blender Delay + Pneumatic Delay
Tube leak range: 10 – 50%

Precision: ± 10%
Resolution: 1% ml
Dynamic compliance Range: 0-500 ml/mbar
Precision: ± 8%
Resolution: 0.1 – 1 ml/mbar
Resistance Range: 0 – 5000 mbar/l/s
Precision: ± 8%
Resolution: 0.1 mbar/l/s
Overdistension index C20 / C Range: 0–5

Resolution: 0.1
Inspiratory O2 concentration Range: 18 – 100 Vol%
Precision: ± 3%
Drift: < 1 Vol% per month. < 15% rel. over entire service life
Pressure influence: Proportional to change in partial pressure
Warm-up time: max. 3 minutes (< 30 minutes with new O2 sensor)

20.4 Resistance Values
System resistance at 30 l/min < 20 mbar/l/s
Inspiratory resistance < 12 mbar/l/s
Expiratory resistance < 8 mbar/l/s
20.5 Parameter Defaults in Configurations Menu

Tubing set nCPAP • MediJet ®
• Infant Flow ®
• Infantflow LP ®
• Inspire™
O2 Flush time • 30 seconds

• 60 seconds
• 120 seconds
Automatic O2 calibration • 21% Vol.

• 21% Vol. and 100% Vol.
I-time settings • Frequency / I-time

• I-time / E-time
Manual breath • 2 – 30 Seconds
Manual breath HFO • ON

• OFF
Trigger mode • Volume trigger

• Flow trigger
Triggered breath signal tone • With signal tone

• Without signal tone
Termination criteria PSV • 5 – 35%
Alarm delay Pmin. nCPAP • 1 – 10 seconds
V limit signal tone • ON

• OFF
20.6 Dimensions / Weight

WxHxD 30 cm x 37 cm x 40 cm
Weight Approx. 20 kg with HFO module

Approx. 14 kg without HFO module

20.7 Ratings
Pressurised air supply 2.0-6.5 bar / max. 40 l/ min. Connection thread: NIST
Oxygen supply 2.0-6.5 bar / max. 40 l/min. Connection thread: NIST
Power supply 100-240 VAC

0.9 – 0.5 A
50/60Hz
external 24 VDC 4 A
(no charging when connected via external battery connector)
Power rating IPPV mode: max. 70 W

HFO mode: max. 100 W
Standby , fabian connected to mains: 35 W ( battery charging )
Internal Battery 16.8 V with 4500 mAh

max. charging time: 5 hours
internal NIMH Battery is Maintenance free
battery charge is continuously monitored
Battery life in HFO mode: 1 hour
Battery life in conventional mode (IPPV): 2.5 hour
Sound pressure Max. 52 dB (A)
Device fuse T 1.0 A L / from HW rev. 1.8: T 1.25 A L
Safety class Type B ≙ EN 60601-1
Certification IEC 60601-1; IEC 60601-1-2; IEC 60601-1-8; IEC 6060601-2-12
Classification to EC directive 93/42/EEC Class II b
IP Protection IPX1, Protected against falling water Equivalent to 3-5mm

rainfall per minute for a duration of 10 minutes. Unit is placed
in its normal operating position.
20.8 Data storage

Trend maximum 5 days
storage every 30 seconds
Alarms maximum 1.000 messages
Log Maximum 10 Log Files.

Log is stored during power failure
When Log capacity is reached index is shifted and oldest log
file deleted

20.9 Applied Parts
Applied parts for the fabian HFOi are the Tube set and Flow Sensor.
20.10 Device Checks

The following internal device checks are performed on start-up:
• COM: Communication between GUI and Conductor PIC.

• I2C: Communication between GUI to Acu PIC, FRAM and Multiplexer.
• PIF: Communication between GUI and Parallel Interface
• DIO: Communication between GUI and Digital I/O.
• SPI: Communication between GUI and Monitor PIC.
• Voltage: Voltage Error Check via SPI
• Relais: Relais Check via SPI
• SPICks: SPI Checksum
In addition an audible alarm can be heard on start-up. The user must check if this alarm can be heard to
verify that the speaker is functioning.

20.11 Gas blender function
The air/oxygen blender provides a gas blend with adjustable proportions of oxygen and air.
Gas from the central gas supply enters the device via the gas input connections.
Blending of the gases occurs via two proportional valves.
The proportional valves, which also act as return
5 valves, prevent the return flow of a gas into the supply cable
of the other gas.
An oxygen sensor measures the inspiratory oxygen concentration.
4
3
1. Oxygen 2.0 – 6.5 bar

2. Air 2.0 – 6.5 bar
3. Filter
4. Pressure Regulator
5. P sensor
6. Proportional valve
7. To Manifold
The minimum base flow is 4 l/min in all modes except in O2 Therapy.
For more information, please refer to the technical service manual
20.12 Acoustic Energy

Acoustic pressure from the alarm sounds at the workstation. The operator position is defined with 1 m
distance of the front panel of the device
Lowest sound pressure level of alarm 56.6 dB

Highest sound pressure Level of alarm: 72.0 dB
Weighted sound pressure level in 1m distance: 43dB

21. Electromagnetic Compatibility Statement
Note: "fabian HFOi" is a MEDICAL APPLIANCE subject to specific precautionary measures with regard to
EMC and must be installed and started up according to the notices according to the instructions in this
manual.
Warning: Portable and medical HF communication devices could impact MEDICAL APPLIANCES!
Warning: Never use "fabian HFOi" directly adjacent to, or stack with other apparatuses. If unavoidable, be
sure to monitor the equipment for proper operation with this set-up.
Warning: Using other accessories, cables or converters with "fabian HFOi" may result in increased
electromagnetic interference and reduce the immunity of "fabian HFOi".
Note: The key performance characteristics of the "fabian HFOi" ventilator are:
• fabian HFOi must operate within the defined specifications and the medical purpose.
Failure to meet these specifications will result in respiration being stopped.
• For this reason a second, stand-alone ventilation unit must always be available,
e.g. resuscitation bag.
Guideline and manufacturer declaration – electromagnetic emission
The device "fabian HFOi" is intended for operation in the environment described below. The customer or
user of the "fabian HFOi" apparatus should ensure it is operated in this type of environment.
EMI measurement Compliance Electromagnetic environment – guideline
HF emission CISPR 11 Group 1 The device "fabian HFOi" uses HF energy solely for internal
operation. Its HF emission is thus very low and interference
with adjacent apparatuses is unlikely.
HF emission CISPR 11 Class A The device "fabian HFOi" is suitable for use in all other
areas except residential areas and areas directly connected
Emission of harmonics Class A
to a public mains supply which also supplies buildings
IEC 61000-3-2
used for residential purposes.
Emission of voltage Met
fluctuations / flickers
IEC 61000-3-3

Guideline and manufacturer declaration – electromagnetic immunity
The device "fabian HFOi" is intended for operation in the environment described below. The customer or
user of the "fabian HFOi" apparatus should ensure it is operated in this type of environment.
Immunity testing IEC 60601 Compliance level Electromagnetic environment – guideline

test level
Electrostatic ± 6 kV ± 6 kV contact Floors should be wooden or concrete or

discharge (ESD) contact ± 8 kV air tiled with ceramic tiles. For flooring made
± 8 kV air from synthetic materials the relative air
IEC 61000-4-2 humidity must be no less than 30%.
Quick electric ± 2kV for ± 2kV for power The mains quality should correspond to
transients/burst power cords cords typical business or hospital environments.
IEC 610004-4 ± 1kV for in- ± 1kV for in-/output

/output cables
cables
Surges ± 1 kV lead to ± 1 kV lead to lead The mains quality should correspond to

lead typical business or hospital environments.
IEC 61000-4-5 ± 2 kV lead to
± 2 kV lead to ground
ground
Voltage drops, <5% UT <5% UT The mains quality should

temporary power (>95% drop of UT) (>95% drop of UT) for correspond to typical business or
failures and for ½ period ½ period hospital environments. If the
fluctuations operator of the "fabian HFOi"
IEC 61000-4-11 40% UT 40% UT requires continued use in the event
(60% drop of UT) (60% drop of UT) for of a power failure we recommend
for 5 periods 5 periods connecting the "fabian HFOi" to an
uninterruptible mains supply or a
70% UT 70% UT battery.
(30% drop of UT) (30% drop of UT) for
for 25 periods 25 periods
<5% UT <5% UT
(>95% drop of UT) (>95% drop of UT) for
for 5 seconds 5 seconds
Magnetic field at 3 A/m 3 A/m Magnetic fields at the mains

supply frequency frequency should correspond to
(50/60 Hz) typical values in business and
IEC 61000-4-8 hospital environments.
Remark UT is the mains alternating voltage prior to applying the test level.

Guideline and manufacturer declaration – electromagnetic immunity
The device "fabian HFOi" is intended for operation in the environment described below. The customer or user of the "fabian HFOi"
apparatus should ensure it is operated in this type of environment.
Immunity IEC 60601 Compliance Electromagnetic environment – guideline

testing test level level
Never use portable or mobile radio devices closer to the "fabian
HFOi", including cables, than the recommended safety
distance calculated using the equation applicable to the
transmission frequency.
Recommended safety distance
HF interference 3 Veff 10 V d = 0.35√P

currents 150 kHz to 80 MHz
IEC 61000-4-6 beyond ISM bands a
10 Veff 10 V d = 1.2√P
150 kHz to 80 MHz
within ISM bands b
HF interference 10 V/m 10 V/m d = 1.2√P 80 MHz to 800 MHz

radiation 80 MHz to 2.5 GHz d = 2.3√P 800 MHz to 2.5 GHz
IEC 61000-4-3
P being the transmitter’s nominal rating in Watts (W) per

manufacturer specifications and d being the recommended
safety distance b in metres (m).
The field strength of stationary radio transmitters should be

below the compliance level d on all frequencies as tested on
site c.
Interference may occur in proximity of apparatuses bearing

the following symbol:
REMARK 1 At 80 MHz and 800 MHz the higher frequency range applies.
REMARK 2 These guidelines may not apply to all case. The propagation of electromagnetic quantities is influenced by
absorption and reflexion of buildings, objects and people.
a The ISM bands (industrial, scientific and medical) between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to
13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.7 MHz.
b The compliance levels in ISM frequency bands between 150 kHz and 80 MHz and between 80 MHz and 2.5 GHz are defined
as such so as to decrease the probability of mobile/portable transmitters causing interference in the event they are
accidentally brought in to the vicinity of the patient. For this reason an additional factor of 10/3 is used when calculating
the recommended safety distance of transmitters in this frequency range.
c In theory the field intensity of stationary transmitters, as e.g. base units of radio telephones (mobile/cordless) and mobile
land radio devices, amateur radio stations, AM and FM radio stations and television stations cannot be predefined
precisely. A study of the location should be conducted to determine the electromagnetic environment with regard to
stationary transmitters. If the field intensity at the location where the "fabian HFOi" is used exceeds the above compliance
levels, "fabian HFOi" should be monitored for proper function. If unusual performance characteristics are observed,
additional measures may be required, as e.g. changing the direction or location of the "fabian HFOi".
d Above a frequency range of 150kHz to 80MHz the field intensity should be below 10 V/m.

Recommended safety distances between portable and mobile
HF communication devices and the device "fabian HFOi"
"fabian HFOi" is intended to be operated in an electromagnetic environment with controlled HF

interferences. The operator of the "fabian HFOi" can help avoid electromagnetic interference by
maintaining the minimum distance between portable and mobile HF telecommunication devices
(transmitters) and the device "fabian HFOi" – depending on the output rating of the communication
device, as listed below.
Maximum Safety distance depending on transmission frequency

transmitter power m
output
150 kHz to 80 150 kHz to 80 MHz 80 MHz to 800 MHz to
W
MHz outside within ISM bands 800 MHz 2.5 GHz
ISM bands
d = 0.35√P d = 1.2√P d = 1.2√P d = 2.3√P
0.01 0.04 0.12 0.12 0.23
0.1 0.13 0.38 0.38 0.73
1 0.40 1.2 1.2 2.3
10 1.3 3.8 3.8 7.3
100 4.0 12 12 23
For transmitters with a maximum power output not listed in the above table the recommended safety
distance d in metres (m) can be determined using the equation from the corresponding column, with P
being the transmitter’s maximum power output Watts (W) per the transmitter’s manufacturer
specifications.
REMARK 1 At 80 MHz and 800 MHz the safety distance of the higher frequency applies.
REMARK 2 The ISM bands (industrial, scientific and medical) between 150 kHz and 80 MHz are 6.765 MHz
to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.7 MHz.
REMARK 3 An additional factor of 10/3 is used when calculating the recommended safety distance for
transmitters within the ISM frequency between 150KHz and 80 MHz and between 80MHz and 2.5GHz to
reduce the probability of mobile/portable transmitters causing interference if accidentally brought into
the vicinity of the patient.
REMARK 4 These guidelines may not apply to all case. The propagation of electromagnetic quantities is
influenced by absorption and reflexion of buildings, objects and people.

This manual is only valid for devices
with SW Version: 3.4
7. Edition – 3 / 2016
Guideline 93/42/EWG

Fabrik im Schiffli
CH-8816 Hirzel / Switzerland
T +41 44 729 70 80
F +41 44 729 70 81
info@acutronic-medical.ch
www.acutronic-medical.ch

IFU Fabian HFOi 3 4 English

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Ventilation Beyond Limits

2 / 99 fabian HFOi | SW 3.4

1.2 Notices and Warnings................................................................................................................................................ 8

1.3 Hardware Version Identification .............................................................................................................................. 9

1.4 Symbols ....................................................................................................................................................................... 9

2. General Notices ..................................................................................... 11

2.2 Maintenance ............................................................................................................................................................. 12

2.3 Liability for Functionality / Damages .................................................................................................................... 13

2.4 Intended use ............................................................................................................................................................. 13

2.5 Scope of Delivery...................................................................................................................................................... 13

2.6 Contra-indications ................................................................................................................................................... 14

3. System overview ................................................................................... 15

3.2 Rear Panel ................................................................................................................................................................. 15

4. Operation and Display ........................................................................... 17

4.2 Display concept structure ....................................................................................................................................... 18

4.3 Ventilation Menu ...................................................................................................................................................... 23

fabian HFOi | SW 3.4 3 / 99

4.4 Graphics Menu.......................................................................................................................................................... 26

5. Preparing for Operation ........................................................................ 31

5.2 Establish Gas Supply ............................................................................................................................................... 31

5.3 Connect tube set ...................................................................................................................................................... 32

5.4 Patient circuit assembly .......................................................................................................................................... 33

5.5 Connect nCPAP Tubing ........................................................................................................................................... 37

5.6 Switching On the device.......................................................................................................................................... 38

5.7 Switching Off the device.......................................................................................................................................... 38

6. Device Check fabian HFOi ...................................................................... 39

7. Configurations Menu ............................................................................. 40

7.2 Display ....................................................................................................................................................................... 44

7.3 Ventilation parameter settings............................................................................................................................... 46

7.4 Patient Data .............................................................................................................................................................. 48

7.6 Date / Time ............................................................................................................................................................... 49

7.7 Tools ......................................................................................................................................................................... 50

7.8 Info ......................................................................................................................................................................... 50

4 / 99 fabian HFOi | SW 3.4

8. Alarm Limits Menu ................................................................................ 52

8.2 Alarm Log .................................................................................................................................................................. 55

8.3 Nurse call relay ......................................................................................................................................................... 55

9. Battery Operation ................................................................................. 56

9.2 Operating on External Power Source .................................................................................................................... 57

10. Function Fields – Ventilation Parameters .............................................. 58

11. Ventilation Modes ................................................................................. 62

11.3 SIMV ......................................................................................................................................................................... 64

11.4 SIMV + PSV ............................................................................................................................................................... 65

11.5 PSV ......................................................................................................................................................................... 66

11.6 CPAP ........................................................................................................................................................................ 66

11.7 nCPAP / duoPAP .................................................................................................................................................... 67

11.9 HFO ......................................................................................................................................................................... 68

11.10 Ventilation Additives............................................................................................................................................ 69

11.11 Special Functions ................................................................................................................................................ 70

fabian HFOi | SW 3.4 5 / 99

12.2 Physiological Alarm ............................................................................................................................................... 73

12.3 Other Alarm............................................................................................................................................................. 74

13. Replacing the Oxygen Sensor ................................................................ 75

14. Service and Maintenance Intervals ........................................................ 76

15. Sterilisation/Cleaning/Disinfection ....................................................... 77

16. Setting Ranges and Parameters ............................................................ 78

17. Standard Accessories ............................................................................ 82

18. Guide to Volume Guarantee................................................................... 83

18.2 Settings to start with ............................................................................................................................................. 84

18.3 How to start VG function ....................................................................................................................................... 84

18.4 Setting up the ventilator PSV+VG......................................................................................................................... 87

19. Special Procedures................................................................................ 88

20. Technical Specifications ........................................................................ 89