ACUTRONIC fabian Therapy evolution User manual

Ref: 121003.EN / Date: 2018-06-18
Warning
Carefully read the instructions of
use before using the ventilator to
familiarise yourself with the function
of the equipment
Ventilation Beyond Limits
fabian Therapy evolution
Instructions for use
SW 5.0

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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.
Manufactured by:
ACUTRONIC Medical Systems AG
Fabrik im Schiffli
8816 Hirzel / Switzerland
Tel: [phone]
Fax: [phone]
e-mail: [email protected]
www.acutronic-medical.ch

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Table of Contents
1Working with the instructions........................................... 6
1.1 Document Structure............................................................................................6
1.2 Notices and Warnings ........................................................................................6
1.3 Hardware Version Identification........................................................................7
1.4 Symbols ...............................................................................................................7
2General Notices................................................................. 9
2.1 Always Observe ..................................................................................................9
2.2 Maintenance ......................................................................................................11
2.3 Liability for Functionality / Damages..............................................................11
2.4 Intended use......................................................................................................11
2.5 Scope of Delivery..............................................................................................12
2.6 Contra-indications ............................................................................................12
3System overview..............................................................13
3.1 Front Connections ............................................................................................13
3.2 Rear Panel..........................................................................................................14
4Operation and Display .....................................................16
4.1 Control options .................................................................................................16
4.1.1 Buttons........................................................................................................................................... 17
4.1.2 Rotary pulse knob........................................................................................................................... 17
4.2 Display concept structure................................................................................18
4.2.1 Display areas.................................................................................................................................. 18
4.2.2 Display screen................................................................................................................................ 18
4.2.3 Information bar............................................................................................................................... 19
4.2.4 Numeric field / Alarm limits ............................................................................................................. 20
4.2.5 Graphic field................................................................................................................................... 20
4.2.6 LED Indicators................................................................................................................................ 21
4.3 Ventilation Menu ...............................................................................................22
4.3.1 Operation –General....................................................................................................................... 22
4.3.2 Operation –Settings....................................................................................................................... 23
4.3.3 Ventilation parameter dependency ................................................................................................. 24
4.3.4 Locking ventilator parameters......................................................................................................... 24
4.4 Graphics Menu..................................................................................................25
4.4.1 Trend Menu.................................................................................................................................... 26
5Preparing for Operation...................................................27
5.1 Establish Power Supply ...................................................................................27
5.2Establish Gas Supply .......................................................................................27
5.3 Connect tube set...............................................................................................28
5.4 Connect flow sensor in NIV trigger (optional) ...............................................29
5.5 Switching On the device ..................................................................................29
5.6 Switching Off the device ..................................................................................30
6Device Check....................................................................31
7Configurations Menu........................................................32

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7.1 Calibration .........................................................................................................34
7.1.1 Calibration Menu at Therapy (only with flow sensor connector) ...................................................... 34
7.1.2 O2Sensor Calibration..................................................................................................................... 35
7.1.3 Flow Sensor Calibration.................................................................................................................. 36
7.1.4 SpO2Module.................................................................................................................................. 36
7.2 Display ...............................................................................................................37
7.2.1 Touch Screen Settings................................................................................................................... 38
7.2.2 Trend / Graph Display..................................................................................................................... 38
7.3 Ventilation parameter settings ........................................................................39
7.3.1 Standard Hospital Settings ............................................................................................................. 40
7.4 Patient Data .......................................................................................................41
7.5 Language ...........................................................................................................41
7.6 Date / Time.........................................................................................................42
7.7 Tools...................................................................................................................42
7.8 Info 43
7.9 Service Mode.....................................................................................................43
8Alarm Limits Menu ...........................................................44
8.1 Automatic Alarm Limits....................................................................................46
8.1.1 Alarm Conditions............................................................................................................................ 46
8.1.2 Automatic Alarm Presets................................................................................................................ 46
8.2 Alarm Log ..........................................................................................................47
8.3 Nurse call relay..................................................................................................47
9Battery Operation............................................................48
9.1 Power Failure.....................................................................................................49
9.2 Operating on External Power Source .............................................................49
10 Function Fields –Ventilation Parameters.........................50
11 Ventilation Modes............................................................51
11.1 nCPAP / duoPAP...............................................................................................51
11.2 O2Therapy mode (High and Low flow oxygen therapy) HFNC ....................52
11.3 Special Functions .............................................................................................52
11.3.1 Manual inspiration (man. Breath).................................................................................................... 52
11.3.2 O2Flush / Preoxygenation.............................................................................................................. 52
11.3.3 Standby –stopping / pausing mechanical ventilation...................................................................... 53
12 Error –Cause –Solution –Alarms.....................................54
12.1 Application error ...............................................................................................57
13 Replacing the Oxygen Sensor...........................................58
14 Service and Maintenance Intervals ..................................59
15 Sterilisation / Cleaning / Disinfection...............................60
16 Setting Ranges and Parameters.......................................61
17 Standard Accessories.......................................................62
18 Technical Specifications ..................................................63

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18.1 Ambient Conditions..........................................................................................63
18.2 Monitoring..........................................................................................................63
18.3 Measuring ..........................................................................................................64
18.4 Settings in Ventilation Menu............................................................................64
18.5 Dimensions / Weight.........................................................................................64
18.6 Ratings...............................................................................................................65
18.7 Data storage ......................................................................................................66
18.8 Applied Parts.....................................................................................................66
18.9 Device Checks...................................................................................................66
18.10 Gas blender function........................................................................................67
18.11 Acoustic Energy................................................................................................68
19 Electromagnetic Compatibility Statement.......................69

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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
DANGER indicates a not directly imminent but latent hazard which may result in
death or bodily injury unless prevented.
ATTENTION indicates a risk which may result in equipment damage when not
avoided.

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1.3 Hardware Version Identification
The hardware version can be identified from the device serial number.
Serial number: xxyyxx-nnnn, yy = Hardware version
From 1st of January 2016 the serial number has been changed to AT-xxxxx
The reason for it is,that the HW revision is only valid when leaving the factory.
1.4 Symbols
Symbol
Description
VDC 12 –24V 4A
External power supply input
USB connection
Network connection RJ45
Connection for external trigger
Opt.1
Optional connector
Data input / Data output RS232
Nurse call signal output
Caution, refer to operator’s manual for important safety information / 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

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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
Batch 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

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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.

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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: be sure that the gas intake ports are not obstructed
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.
Warning: only use air and O2hoses which are in accordance to the ISO 5359
standard
Warning: this VENTILATOR is a high flow device and should only be connected to
a pipeline installation that allows the indicated flow
Warning: this VENTILATOR shall not be used with nitric oxide
Warning: only use this ventilator in combination with an external monitoring (e.g
SpO2) device

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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 “14. Service and Maintenance Intervals”
Original packaging should be kept for the possible return of the unit. Only original
packaging ensures optimal protection of the equipment during transport. If it is
necessary to return the equipment during the warranty period, the manufacturer is
not liable for damages caused by incorrect packaging.
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 support 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 Therapy evolution is intended for premature infants, new-borns as well as children
weighting up to 30 kg.
The fabian Therapy evolution is intended for “in-patient use” in hospitals, medically-used rooms
and intra-hospital patient transport.
The fabian Therapy evolution is an electronically microprocessor controlled ventilator.
The fabian Therapy evolution ventilates with excess pressure based on the continuous-flow
principle. (Time cycled and pressure limited)
Oxygen is metered by the integrated Air/O2blender.
The oxygen concentration is measured internally with a galvanic oxygen sensor.

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The ventilator is intended for the following, non invasive, ventilation methods:
•O2Therapy
•NIV ventilation nCPAP/duoPAP with variable flow generators
(Infant Flow®, Infant Flow LP®, InspireTM, Medijet®
The equipment is operated by a physician or at his orders by a professional with technical training
in this task, where up on any user must be trained on this equipment and familiar with the
operator’s manual and the use of the equipment.
The fabian Therapy evolution is not approved for use in a homecare environment.
2.5 Scope of Delivery
This product includes the following items:
•1 x fabian Therapy evolution ventilator (#121001)
•2 x Infant flow connecting tube (#1530010.01)
•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 Therapy evolution 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 at
this age.
Detailed studies and experience can be requested from the following address:
ACUTRONIC Medical Systems AG
Fabrik im Schiffli
8816 Hirzel / Switzerland
Tel: [phone]
Fax: [phone]
Email: [e-mail]

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3 System overview
3.1 Front Connections
1
Connection for fresh gas
2
Pressure measuring tube port

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3.2 Rear Panel
1
Mains connection with fuse holder
2
Terminal stud for potential equalization
3
Connection for external voltage supply 12 –24V DC
With HW Rev. 1.0 use only with connection cable Part. No. 151401
4
Nurse call, max. Switching voltage 50 VDC
5
Covered with a faceplate / Flow sensor connector (from SN AT-03001)
6
Network connection for data management
(For connection to network with minimum 3 KV galvanic isolation)
7
USB connection for data output (log file), software update. Connection for Masimo SpO2
module.
8
RS232 interface, service, PDMS
9
Connection for compressed air supply 2.0 –6.5 bar / 40 l/min
10
Connection for future use, covered with a faceplate
11
Oxygen sensor
12
Connection for future use, covered with a faceplate
13
Connection for oxygen “O2” supply 2.0 –6.5 bar / 40 l/min

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For Adapter to DISS see “17. Standard Accessories”
Warning: Do not connect Ethernet, Nurse call, USB, R232 ports 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: 30 V / 1 A DC or AC
USB: 5 V/150 mA
RS232: 3.3 V/100 mA

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4 Operation and Display
4.1 Control options
The control panel features two key elements:
1. The display (Touch Screen) allows the
direct control of the ventilator parameters
by tapping defined buttons on the graphic
user interface.
2. Fields in the lower section of the touch
screen are operated with the buttons
underneath.
3. The button /-control panel incremental knob
(combined with a push button and selection
dial)

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4.1.1 Buttons
The key pad features 2 rows of buttons with various functions.
Manual breathing
Used to apply a manual breath. Available in all the ventilation modes.
O2Flush
Used to start O2flush. Flush concentration and time can be preset.
Cursor buttons
These buttons serve as control in several menus.
Screen contrast setting
Used to adjust the brightness of the screen.
Menu / Calibration
Used to access the configuration and calibration menus. Pressing once will open
the calibration menu; pressing again will open the configuration menu.
Waves
Switches to Waves display and values are shown in big letters.
Home
Displays the main screen for selecting the respiration mode.
Alarm limits
Switches to the alarm limits configuration.
On / off –start / stop
For switching the device on and off, stopping and resuming ventilation.
Alarm Mute
For acknowledging and muting alarms for a maximum duration of 120 seconds.
Subsequent alarms with higher priority are only displayed optically during
muting.
4.1.2 Rotary pulse knob
The rotary pulse knob combines a push button with a rotary knob for executing
various settings, selections and confirmation options.

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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
4.2.2 Display screen
The 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 and ventilation mode
2.Pressure graph
3.Parameter setting field
4.Selection or display of operating mode
5.Numeric field / alarm limits
Depending on the display mode selected,
individual fields may be shown/hidden.
Display field options will be described later.
1
1
5

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4.2.3 Information 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.Patient data available
Nurse call active / inactive
Battery charge status
2.Ventilation mode, info and alarm display
3.Alarm Mute (time remaining until alarm
reactivates)
Time / date
The patient symbol indicates patient data
associated with the current ventilator operation
is saved to the device.
The nurse indicates Nurse Call is activated
Ventilation mode / Info / and Alarm display
Displays ventilation mode and, if applicable,
additional current information and notices. A
red blinking info bar also alerts the user to
active alarms.
If screen lock is in use, the symbol for locked
screen is displayed.

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4.2.4 Numeric field / Alarm limits
The numeric field are showing all measured values
In the numeric field the selected ventilation
mode related measured values are displayed.
There can be multiple pages of numeric fields.
To go to the next page, press the button
underneath 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 knob, change the value
•to confirm the setting, either touch
parameter button again, or push rotary
pulse knob again.
To automatically set the alarm limits, select
parameter and touch AUTOSET button.
Alarm limits
4.2.5 Graphic field
The button Waves enlarges the measured values
Displays the current values in big letters and
also the actual Wave