ACUTRONIC fabian +nCPAP evolution User manual

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Warning
Carefully read the instructions of use
before using the ventilator to
familiarise yourself with the function of
the equipment
Ventilation Beyond Limits
fabian +nCPAP evolution
and Auxiliary Systems
Instructions for Use, Software Version 5.1.x

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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.
This document cannot be copied, reproduced, translated, stored in a retrieval system, transmitted in any form, or
reduced to any electronic medium or machine-readable form, in whole or in part, without the written permission of
ACUTRONIC Medical Systems.
Manufactured by
ACUTRONIC Medical Systems AG
Fabrik im Schiffli
8816 Hirzel / Switzerland
Tel: [phone]
Fax: [phone]
e-mail: GMB-CH-AMS-Inf[email protected]
www.acutronic-medical.ch
For any additional parts and accessories, contact your local distributor for available items and price list.

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Contents
1Introduction........................................................................................................................7
1.1 Working with the instructions .......................................................................................7
1.2 Notices and warnings...................................................................................................7
1.3 Applicable product versions.........................................................................................7
1.4Symbols.......................................................................................................................8
2Warnings cautions and notices......................................................................................11
2.1 Always observe..........................................................................................................11
2.2 Maintenance..............................................................................................................13
2.3 Liability for .............................................................................14
2.4 Intended use..............................................................................................................14
3System overview..............................................................................................................15
3.1 Scope of delivery.......................................................................................................15
3.2 Contraindications.......................................................................................................15
3.3 fabian front connections.............................................................................................15
3.4 Rear panel.................................................................................................................16
3.4.1 Rear panel of devices without DC connector (from SN AN-04000) .....................................16
3.4.2 Rear panel of devices with DC connector (till SN AN-03999)..............................................17
3.4.3 General hardware characteristics.........................................................................................18
4System functions and displays.......................................................................................19
4.1 Control panel options.................................................................................................19
4.1.1 Function buttons ...................................................................................................................19
4.1.2 Rotary push knob..................................................................................................................20
4.2 Display concept structure...........................................................................................21
4.2.1 Display areas........................................................................................................................21
4.2.2 Display screen......................................................................................................................21
4.2.3 Information bar.....................................................................................................................22
4.2.4 Numeric field / Alarm limits...................................................................................................23
4.2.5 Graphic field..........................................................................................................................25
4.2.6 LED Indicators ......................................................................................................................25
4.3 Ventilation menu........................................................................................................27
4.3.1 Operation General.............................................................................................................27
4.3.2 Operation Settings.............................................................................................................28
4.3.3 Ventilation parameter dependency.......................................................................................29
4.3.4 Locking ventilator parameters ..............................................................................................29
4.4 Graphics menu..........................................................................................................30
4.4.1 Waves...................................................................................................................................31
4.4.2 Loops....................................................................................................................................32
4.4.3 Trend Menu ..........................................................................................................................33
5System operation.............................................................................................................34
5.1 Preparing for operation..............................................................................................34
5.1.1 Connect the power supply....................................................................................................34
5.1.2 Connect the gas supply........................................................................................................34
5.1.3 Connect the tubing set..........................................................................................................35

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5.2 Patient circuit assembly.............................................................................................36
5.2.1Recommended positioning of temperature probe for humidifier..........................................37
5.2.2 Use of dual limb patient circuit.............................................................................................38
5.2.3 Connect nCPAP tubing ........................................................................................................40
5.2.4 Triggering in DUOPAP mode with flow sensor (optional)....................................................40
5.3 System start-up.........................................................................................................41
5.4 Device check.............................................................................................................43
5.5 System standby / pause ............................................................................................45
5.6 System shutdown......................................................................................................46
5.7 Emergency shutdown................................................................................................47
6Configurations menu.......................................................................................................48
6.1 Calibration.................................................................................................................49
6.1.1 Flow sensor..........................................................................................................................50
6.1.2 O2Sensor............................................................................................................................52
6.1.1SpO2module .......................................................................................................................53
6.2 Body weight setting ...................................................................................................53
6.3 Display ......................................................................................................................53
6.3.1 Touch screen settings..........................................................................................................54
6.3.2 ............................................................................................................55
6.4 Ventilation parameter settings ...................................................................................56
6.5 Patient data...............................................................................................................58
6.6 Language..................................................................................................................59
6.7  ................................................................................................................59
6.8 Tools .........................................................................................................................60
6.9 Information ................................................................................................................60
6.10 Service mode ............................................................................................................61
7Alarms..............................................................................................................................62
7.1 Alarm limits menu......................................................................................................62
7.1.1 Automatic alarm limits..........................................................................................................64
7.1.2 Configurable alarms.............................................................................................................65
7.2 Alarm log...................................................................................................................66
7.3 Nurse call relay..........................................................................................................66
7.4 Alarm causes and solutions.......................................................................................67
7.4.1 Alarms table .........................................................................................................................67
7.4.2 Pressure release behaviour .................................................................................................74
7.4.3 Application error...................................................................................................................75
7.4.4 Watchdog alarms .................................................................................................................76
8Battery operation.............................................................................................................77
9Operating on external power source (devices with SN till AN-03999) .........................78
10 Ventilation parameters....................................................................................................79
11 Ventilation modes............................................................................................................83
11.1 IPPV..........................................................................................................................84
11.2 SIPPV........................................................................................................................85
11.3 SIMV .........................................................................................................................86

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11.4 SIMV + PSV...............................................................................................................87
11.5 PSV...........................................................................................................................88
11.6 CPAP.........................................................................................................................88
11.7  .....................................................................................................89
11.8 O2Therapy mode (high and low flow oxygen therapy) HFNC....................................90
11.9 Ventilation Additives ..................................................................................................91
11.9.1 Volume limit..........................................................................................................................91
11.9.2 Volume guarantee ................................................................................................................91
11.10 Special functions........................................................................................................92
11.10.1 Manual inspiration (manual Breath)......................................................................................92
11.10.2 Nebulizing medications (optional).........................................................................................92
11.10.3 O2....................................................................................................92
12 Accessories and options.................................................................................................93
12.1 Accessories List.........................................................................................................93
12.2 SpO2module.............................................................................................................96
12.2.1 Setting up the Masimo sensor..............................................................................................96
12.2.2 Sensitivity mode....................................................................................................................97
12.2.3 Fast SAT mode.....................................................................................................................97
12.2.4 Alarm delay...........................................................................................................................98
12.2.5 SpO2averaging time............................................................................................................98
12.3 PRICO.......................................................................................................................99
12.3.1 General information on PRICO.............................................................................................99
12.3.2 Setting up PRICO ...............................................................................................................101
12.3.3 PRICO Ventilation modes...................................................................................................103
12.3.4 PRICO disabling alarms .....................................................................................................104
12.3.5 PRICO re-enabling cases...................................................................................................104
12.3.6 PRICO errors......................................................................................................................104
12.4 External communication, PDMS ..............................................................................106
13 Replacing the oxygen sensor .......................................................................................107
14 Ventilator service and maintenance intervals..............................................................108
14.1 Disposal...................................................................................................................108
15 Sterilization ∕ cleaning ∕ disinfection .............................................................................109
15.1 fabian +nCPAP evolution.........................................................................................109
15.1.1 Preparation for disinfection.................................................................................................109
15.1.2 Manual disinfection options ................................................................................................109
15.2 Accessories.............................................................................................................110
15.2.1 Flow sensor cable...............................................................................................................110
15.2.2 Flow sensor ........................................................................................................................112
15.2.3 Exhalation membrane and membrane holder ....................................................................114
15.2.4 Disassembly .......................................................................................................................114
16 Setting ranges and parameters.....................................................................................117
17 Guide to volume guarantee...........................................................................................121
17.1 fabian volume guarantee (VG) operation .................................................................121
17.2 Initial settings...........................................................................................................122

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17.3 How to start the VG function....................................................................................122
17.4 Setting up the ventilator PSV+VG............................................................................124
18 Special procedures........................................................................................................125
18.1 Use of NO (Nitric Oxide)..........................................................................................125
19 Technical specifications ...............................................................................................126
19.1 Ambient conditions..................................................................................................126
19.2 Monitoring................................................................................................................126
19.3 Measuring................................................................................................................127
19.4 Resistance values ...................................................................................................128
19.5 Ventilation menu settings.........................................................................................128
19.6 .................................................................................................129
19.7 Ratings....................................................................................................................129
19.8 Data storage............................................................................................................130
19.9 Applied parts ...........................................................................................................130
19.10 Internal device checks.............................................................................................130
19.11 Gas blender function ...............................................................................................131
19.12 Acoustic Energy.......................................................................................................132
19.13 Essential Performance.............................................................................................133
20 Electromagnetic compatibility statement ....................................................................134
20.1 Devices with SN from AN-04000 .............................................................................135
20.2 Devices with SN till AN-03999.................................................................................139

1 Introduction 7
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1Introduction
1.1 Working with the instructions
These instructions for use describe equipment components and their operation. These instructions
are structured so that you can step your way through the procedures and become familiar with the
operation of the ventilator.
WARNING
Carefully read the instructions for use before using the ventilator.
After you are familiar with the basic construction and operation of the ventilator you can use this
manual as a reference.
1.2 Notices and warnings
This document features three categories of notices and warnings.
WARNING:
Warnings identify conditions or practices that could result in serious adverse reactions or
potential safety hazards.
CAUTION:
Cautions identify conditions or practices that could result in damage to the ventilator or
other equipment.
NOTE:
Notes provide additional information to clarify an explanation or instruction.
1.3 Applicable product versions
This Instructions for Use is applicable for fabian +nCPAP evolution devices running software version
5.1.x, where (x) can be any number.

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1.4 Symbols
The symbols defined in this section may appear in this document and on the equipment label or
labels.
Symbol
Description
Article No.
Batch code
CAUTION
precautions.
Chemical burn warning.
Connection for external trigger
Dangerous voltage warning.
Data input / output RS-232.
Data input / output RS-232.
Disposal information.
DO NOT cover.
DO NOT stack no more than 2 on top.
DO NOT use hooks.
Potential equalisation connection.
Flammability Fire hazard warning.
Sensor
Flow sensor connection
Flow sensor connection.
External power supply input
Fragile, Handle with care.
High Frequency interference warning.
Keep away from heat.
2

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Symbol
Description
Keep dry.
Manufactured withut the use of natural latex or derivatives.
Manufacturer
Marking per Medical Devices Directive 93/42/EEC
Nebulizer (obsolete)
Network Ethernet connection (disabled)
Non-Sterile
NOTE symbol
Nurse Call signal output.
Nurse Call signal output.
Protective Earth ground.
Single use.
This way UP.
Type BF applied part.
Type B applied part
Unplug power before opening housing.
Video Output
USB connection.
Warning regarding operation in explosive areas.
Do not use if package is damaged
Expiration Date
Storage Temperature

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Symbol
Description
Humidity Limitation

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2Warnings cautions and notices
2.1 Always observe
#
Symbol
Description
1.
NOTE:The use of the ventilator requires detailed knowledge and the

described use.
2.
WARNING:Only use this ventilator in combination with an external
monitoring device (for example: SpO2).
3.
WARNING:Only operate the ventilator with accessories recommended by
ACUTRONIC Medical Systems AG.
4.
WARNING:The ventilator must be operated by qualified clinical staff to
ensure immediate remedial action in the event of malfunction.
5.
WARNING: The fabian system and associated auxiliary systems must
NEVER be used in MRI scanning facilities.
6.
WARNING:An alternate ventilation method (for example manual
resuscitation) must always be available when using the ventilator.
7.
WARNING: DO NOT use the ventilator in combination with flammable gases
or narcotic agents or in an oxygen-rich environment to prevent the risk of fire
or explosion.
8.
WARNING:NEVER use the ventilator in explosive environments.
9.
WARNING:An audible signal indicates a system or patient alarm and always
requires action by a trained medical professional.
10.
WARNING:If an alarm condition (other than the exceptions listed within this
manual) occurs while the audible alarm Silence function is engaged, only the
visual alarm indications are displayed.
11.
WARNING:DO NOT silence an audible alarm, engage the audible Alarm
Silence function, or decrease the audible alarm volume if patient safety could
be compromised.
12.
WARNING:DO NOT obstruct the speaker.
Blocking the speaker can result in an inaudible alarm tone.
13.
WARNING:Carefully route patient cabling to reduce the risk of patient
entanglement or strangulation.
14.
WARNING:NEVER connect the ventilator to a patient if an error or
malfunction is detected during equipment check.
15.
WARNING:NEVER connect to electrical devices not mentioned in this

16.
WARNING:Connect only electrical devices which are IEC60601-1 approved.
17.
WARNING:NEVER operate the ventilator while covered or set up in a way
to negatively impact the operation or function.

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#
Symbol
Description
18.
WARNING:Always unplug the ventilator from the power source before
opening the housing.
19.
WARNING:NEVER use anti-static or electrically conductive tubing.
20.
NOTE: The safety and health of the operators are guaranteed by the fact that
the products for example: DO NOT contain any allergenic or mutagenic
materials such as phthalates.
21.
WARNING:The device can only be isolated from the mains power supply by
removing the power cord completely.
Ensure the power socket is always accessible for disconnection.
DO NOT disconnect the power cable unless for Service purposes or
transport.
22.
WARNING:DO NOT modify the equipment.
23.
WARNING:Before applying non-original accessories, ensure that they are
biocompatible. All accessories supplied by ACUTRONIC Medical Systems
for use on fabian ventilators are biocompatible.
24.
WARNING:When connected to a patient DO NOT simultaneously touch the
external power supply cord and the flow sensor connector cable.
25.
WARNING:if the volume of the auditory alarms is set less than the ambient
noise level this might impede an operator to recognize alarm conditions.
26.
WARNING:NEVER cover the ventilator while in use.
27.
WARNING:DO NOT position the ventilator in such a way that this adversely
affects its performance or makes it difficult to disconnect the ventilator from
the mains supply. In case of emergency, removal of the mains plug from the
wall outlet disconnects the ventilator from mains power.
28.
WARNING:in case of ventilator failure, the lack of immediate access to
appropriate alternative means of ventilation can result in patient death.
29.
WARNING:Ensure that alarms are appropriately set before use of ventilator
on a patient.
30.
WARNING:In case portions of the gas pathways through the VENTILATOR
become contaminated with body fluids or expired gases,immediately contact
ACUTRONIC Medical Systems.
31.
WARNING:
•When selecting the neonatal patient size, a Neonatal Flow sensor should
be used.
•When selecting the pediatric patient size, a Pediatric Flow sensor should
be used.
32.
NOTE: In general, it should be noted that ventilation of children should only
be carried out by clinically trained specialists who have sufficient knowledge
of ventilation of patients of the specified age.

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33.
Before use, carefully read the Oximetry Sensor Directions for Use and PC-
Series Patient Cable Directions for Use.
34.
EXPLOSION HAZARD: Do not use the pulse oximeter in the presence of
flammable anesthetics or other flammable substances in combination with
air, oxygen-enriched environments, or nitrous oxide.
35.
Check alarm limit settings each time the pulse oximeter is used.
36.
A pulse oximeter should NOT be used as an apnea monitor.
37.
A pulse oximeter should be considered an early warning device. As a trend
towards patient deoxygenation is indicated, blood samples should be
analyzed by a laboratory co-oximeter to completely understand the patient's
condition.
38.
Always remove the sensor from the patient and completely disconnect the
patient from the pulse oximeter before bathing the patient.
39.
Do not use malfunctioning equipment. Have the pulse oximeter unit repaired
by Masimo or a qualified service person.
40.
ELECTRIC SHOCK HAZARD: Do not remove the pulse oximeter cover.
There are no user-serviceable items inside the oximeter. An operator may
only perform maintenance procedures specifically described in this manual.
ONLY connect IEC 60601-1 or IEC 60950-1 compliant devices to Ethernet,
Nurse call, and RS232 ports.
41.
If the accuracy of any measurement by the pulse oximeter does not seem
reasonable, first check the patient's vital signs by alternate means, and then
check the oximeter for proper functioning.
42.
WARNING:Only use air and O2hoses which are in accordance to the ISO
5359 standard
43.
WARNING:Do not use the ventilator in association with HF (High
Frequency) electrosurgical equipment.
44.
WARNING:Connect SpO2and etCO2sensor cables to the machine before
the patient is connected.
2.2 Maintenance
The device is a ventilator classified as Class IIb according to the European Directive, as such:
•Inspection according to manufacturer specifications is required every 12 months.
•Maintenance must be performed by ACUTRONIC Medical Systems trained personnel 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 Medical Systems parts for repairs.
Note chapte

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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 +nCPAP evolution is intended for premature infants, new-borns as well as children
weighing up to 30 kg.
-professional healthcare environment
including intra-hospital patient transport.
The fabian +nCPAP evolution is an electronically microprocessor controlled ventilator.
The fabian +nCPAP evolution ventilates with positive 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:
•IPPV Intermittent Positive Pressure Ventilation (CMV Controlled Mandatory Ventilation)
•SIPPV Synchronised Intermittent Positive Pressure Ventilation (A/C, Assist Controlled)
•SIMV Synchronised Intermittent Mandatory Ventilation
•SIMV + PSV Synchronised Intermittent Mandatory Ventilation combined with PSV
•PSV Pressure Support Ventilation
•CPAP Continuous positive airway pressure
•NIV ventilation nCPAP/duoPAP with variable flow generators
(Infant Flow®, Infant Flow LP®, InspireTM, Medijet®)
The equipment is operated by a physician or at their orders by a professional with technical training

manual and the use of the equipment.
fabian +nCPAP evolution is not approved for use in a homecare environment.

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3System overview
3.1 Scope of delivery
The fabian +nCPAP evolution product includes the following items:
•One fabian +nCPAP evolution Ventilator
•One Accessory kit:
•One Flow Sensor (reusable)
•One Flow Sensor Cable
•One Test Lung
•Two single limb connecting tube
•One Power Cable (country specific)
•One Instructions for Use (country specific)
3.2 Contraindications
Severe airflow obstruction, and intracranial hypertension, would contraindicate the use of the fabian
+nCPAP evolution neonatal and infant ventilator.
fabian products should not be used in association with HF electrosurgical equipment.
In the event of ventilation for several hours or more, care must be taken for optimal conditioning of
the respiratory gases (warmth, humidification) to optimize secretion mobilization and prevent damage
to mucous membranes.
3.3 fabian front connections
1.
Inspiratory tube port
2.
Connection for nCPAP system based on flow generators (single limb systems)
3.
Proximal pressure measuring tube port
4.
Expiration port
1
2
3
4

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3.4 Rear panel
3.4.1 Rear panel of devices without DC connector (from SN
AN-04000)
1.
Mains connection with fuse holder
2.
Terminal stud for potential equalization
3.
Nurse call connector, max switching voltage 30 VDC
4.
Flow sensor connector
5.
Network connection for data management (disabled)
6.
USB connection for connection of a USB powered nebulizer. Also available when not in
clinical use for data output and software update.
7.
RS232 interface, service, PDMS
8.
Connection for compressed air supply 2.0 6.0 bar / max 40 l/min
9.
Connector for Masimo SpO2module
10.
Oxygen sensor access cover
11.
2 6.0 bar / max 40 l/min
8
1
2
3
4
9
11
5
2
10
7
6

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fabian +nCPAP evolution | SW 5.1.x
Ref: 122003.EN / Date 2019-11-22
3.4.2 Rear panel of devices with DC connector (till SN AN-
03999)
1.
Mains connection with fuse holder
2.
Terminal studs 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 connector, max switching voltage 30 VDC
5.
Flow sensor connector
6.
Network connection for data management (disabled)
7.
USB connection for data output, Software update. Connector for Masimo SpO2 module.
8.
RS232 interface, service, PDMS
9.
Connection for compressed air supply 2.0 6.5 bar / max 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.
2 6.5 bar / max 40 l/min

18
fabian +nCPAP evolution | SW 5.1.x
Ref: 122003.EN / Date 2019-11-22
3.4.3 General hardware characteristics
WARNING:
DO NOT connect Ethernet, Nurse call, USB, R232, SpO2, Flow Sensor ports to anything
other than specified devices.
DO NOT connect anything to Ethernet, Nurse call, and RS232 ports while operating on
battery power.
ONLY connect IEC 60601-1 or IEC 60950-1 compliant devices to Ethernet, Nurse call, and
RS232 ports.
For Adapter to DISS see Accessories.
The pin for the Equipotential connection is provided 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 Equipotential connection
accessible.
Maximum Connected Loads:
Nurse call: Isolated relay output
Max contact load: 30 VDC @ 1A
USB: 5V @ 150 mA max
RS-232: Signal Levels: EIA/TIA-232 Standard
Pin 9 Power: 5V @ 500 mA max (models without DC input)
Isolated
Ethernet: N/A (disabled)
Flow Sensor: Maximum load is one Flow sensor
(Only ACUTRONIC Medical Systems Flow sensors can connect)
Max. Voltage: 5 V
Max operating current: 300 mA per hotwire -> 600 mA total.
SpO2: Max Voltage: 3.3 V
Max operating Current: 200 mA

19
fabian +nCPAP evolution | SW 5.1.x
Ref: 122003.EN / Date 2019-11-22
4System functions and displays
4.1 Control panel options
The control panel features three key elements:
The display Touch Screen (1) allows
the direct control of the ventilator
parameters by tapping defined
buttons on the graphic user interface.
Fields in the lower section (2) of the
touch screen are operated with the
buttons underneath.
The button /-control panel (3) rotary
push knob (combined with a push
button and selection dial)
4.1.1 Function buttons
The key pad features two rows of buttons with various functions.
Manual breath
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
Menu ∕Calibration
Used to access the setting and calibration menus. Pressing once will open
the configuration menu; pressing again will open the calibration menu.
Waves ∕Loops
-/loop display.
Home


1
2
3

20
fabian +nCPAP evolution | SW 5.1.x
Ref: 122003.EN / Date 2019-11-22
The key pad features two rows of buttons with various functions.
Alarm limits
Switches to the alarm limits configuration.
ON ∕OFF –Start ∕Stop
For switching the device ON and OFF, stopping and resuming ventilation.
Alarm Silence
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 push knob
The Rotary Push knob combines a push button with a rotary knob for
executing various settings, selections and confirmation options.