ACUTRONIC fabian +nCPAP evolution User manual

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fabian +nCPAP evolution | SW 5.1.x
Ref: 122003.EN / Date 2019-11-22
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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fabian +nCPAP evolution | SW 5.1.x
Ref: 122003.EN / Date 2019-11-22
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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fabian +nCPAP evolution | SW 5.1.x
Ref: 122003.EN / Date 2019-11-22
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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fabian +nCPAP evolution | SW 5.1.x
Ref: 122003.EN / Date 2019-11-22
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