ACUTRONIC fabian +nCPAP evolution User manual

fabian +nCPAP evolution | SW V5.1.x
Ref: 122003.EN / Date : 26Jan2021
Ventilation Beyond Limits
fabian +nCPAP evolution and Auxiliary Systems
Instructionsfor Use, Software Version 5.1.x

Disclaimer i
fabian +nCPAP evolution | SW V5.1.x
Ref: 122003.EN / Date : 26Jan2021
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: [e-mail]
www.acutronic-medical.ch
For any additional parts and accessories, contact your local distributor for available items and
price list.

ii Table of Contents
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Table of Contents
Disclamer ................................................................................................ i
Table of Contents.................................................................................... ii
1Introduction ...................................................................................... 1
1.1 Working with the instructions .............................................................................. 1
1.2 Notices and warnings ........................................................................................... 1
1.3 Applicable product versions................................................................................. 1
1.4 Symbols................................................................................................................ 2
2Warnings cautions and notices ........................................................... 5
2.1 Always observe (fabian)........................................................................................ 5
2.2 Maintenance......................................................................................................... 8
2.3 Liability for functionality / damages .................................................................... 8
2.4 Intended use......................................................................................................... 9
3System overview ............................................................................. 10
3.1 Scope of delivery ................................................................................................ 10
3.2 Contraindications............................................................................................... 10
3.3 fabian Front connections ................................................................................... 10
3.4 Rear panel .......................................................................................................... 11
3.4.1 Devices without DC connector (from SN AN-04000) ...........................................................11
3.4.2 Devices with DC connector (up to SN AN-03999) ................................................................12
3.4.3 General hardware characteristics .........................................................................................13
4System functions and displays ......................................................... 14
4.1 Control panel options......................................................................................... 14
4.1.1 Function buttons.....................................................................................................................14
4.1.2 Rotary push knob ....................................................................................................................15
4.2 Display concept structure .................................................................................. 16
4.2.1 Display areas............................................................................................................................16
4.2.2 Display screen..........................................................................................................................16
4.2.3 Information bar ......................................................................................................................17
4.2.4 Numeric field / Alarm limits ...................................................................................................18
4.2.5 Graphic field.............................................................................................................................20
4.2.6 LED Indicators..........................................................................................................................20
4.3 Ventilation menu................................................................................................ 21
4.3.1 Operation –General................................................................................................................21
4.3.2 Operation –Settings ...............................................................................................................22
4.3.3 Ventilation parameter dependency ......................................................................................23
4.3.4 Locking ventilator parameters ..............................................................................................23
4.4 Graphics menu ................................................................................................... 25
4.4.1 Waves........................................................................................................................................26

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4.4.2 Loops ....................................................................................................................................... 27
4.4.3 Trend Menu ............................................................................................................................. 28
5System operation .............................................................................29
5.1 Preparing for operation ......................................................................................29
5.1.1 Connect the power supply .................................................................................................... 29
5.1.2 Connect the gas supply ......................................................................................................... 29
5.1.3 Connect the tubing set .......................................................................................................... 30
5.2 Patient circuit assembly .....................................................................................31
5.2.1 Recommended positioning of temperature probe for humidifier ................................... 32
5.2.2 Use of dual limb patient circuit ............................................................................................ 33
5.2.3 Connect nCPAP tubing .......................................................................................................... 35
5.2.4 Triggering in DUOPAP mode with flow sensor (optional).................................................. 35
5.3 System start-up ..................................................................................................36
5.4 Device check .......................................................................................................38
5.5 System standby / pause......................................................................................40
5.6 System shutdown ...............................................................................................41
5.7 Emergency shutdown .........................................................................................42
6Configurations menu........................................................................43
6.1 Calibration ..........................................................................................................44
6.1.1 Flow sensor ............................................................................................................................. 45
6.1.2 O2Sensor ................................................................................................................................ 47
6.1.1 SpO2module .......................................................................................................................... 48
6.2 Body weight setting ............................................................................................48
6.3 Display ................................................................................................................48
6.3.1 Touch screen settings............................................................................................................ 49
6.3.2 Trend / graph display............................................................................................................. 50
6.4 Ventilation parameter settings ...........................................................................51
6.5 Patient data ........................................................................................................53
6.6 Language ............................................................................................................54
6.7 Date / Time .........................................................................................................54
6.8 Tools ...................................................................................................................55
6.9 Information.........................................................................................................55
6.10 Service mode ......................................................................................................56
7Alarms .............................................................................................57
7.1 Alarm limits menu...............................................................................................57
7.1.1 Automatic alarm limits .......................................................................................................... 59
7.1.2 Configurable alarms............................................................................................................... 60
7.2 Alarm log.............................................................................................................60
7.3 Nurse call relay ...................................................................................................60
7.4 Alarm causes and solutions ................................................................................61
7.4.1 Alarms table ............................................................................................................................ 61
7.4.2 Pressure release behaviour................................................................................................... 68

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7.4.3 Application error .....................................................................................................................68
7.4.4 Watchdog alarms ....................................................................................................................69
8Battery operation ............................................................................ 70
8.1 Power failure ...................................................................................................... 71
9Operating on external power source................................................. 72
9.1 (Devices with SN up to AN-03999) ...................................................................... 72
10 Ventilation parameters .................................................................... 73
11 Ventilation modes............................................................................ 76
11.1 IPPV .................................................................................................................... 77
11.2 SIPPV .................................................................................................................. 78
11.3 SIMV.................................................................................................................... 79
11.4 SIMV + PSV .......................................................................................................... 80
11.5 PSV ..................................................................................................................... 81
11.6 CPAP ................................................................................................................... 81
11.7 NCPAP / DUOPAP................................................................................................ 82
11.8 O2Therapy mode............................................................................................... 83
11.8.1 (high and low flow oxygen therapy) HFNC ...........................................................................83
11.9 Ventilation Additives .......................................................................................... 83
11.9.1 Volume limit.............................................................................................................................83
11.9.2 Volume guarantee...................................................................................................................84
11.10 Special functions................................................................................................ 84
11.10.1 Manual inspiration (manual Breath).....................................................................................84
11.10.2 Nebulizing medications (optional)........................................................................................85
11.10.3 O2Flush / preoxygenation .....................................................................................................85
12 Accessories and options................................................................... 86
12.1 Accessories List .................................................................................................. 86
12.2 Spare parts list ................................................................................................... 88
12.3 SpO2module...................................................................................................... 89
12.3.1 Setting up the Masimo sensor ...............................................................................................89
12.3.2 Sensitivity mode......................................................................................................................90
12.3.3 Fast SAT mode.........................................................................................................................90
12.3.4 Alarm delay ..............................................................................................................................91
12.3.5 SpO2averaging time...............................................................................................................91
12.4 PRICO ................................................................................................................. 92
12.4.1 General information on PRICO ..............................................................................................92
12.4.2 Setting up PRICO .....................................................................................................................94
12.4.3 PRICO Ventilation modes .......................................................................................................96
12.4.4 PRICO disabling alarms ..........................................................................................................97
12.4.5 PRICO re-enabling cases ........................................................................................................97
12.4.6 PRICO errors.............................................................................................................................97
12.5 External communication, PDMS ......................................................................... 99

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13 Replacing the oxygen sensor........................................................... 100
14 Ventilator service and maintenance intervals.................................. 101
14.1 Disposal ............................................................................................................102
15 Sterilization / cleaning / disinfection............................................... 103
15.1 fabian +nCPAP evolution ..................................................................................103
15.1.1 Preparation for disinfection ................................................................................................ 103
15.1.2 Manual disinfection options ............................................................................................... 103
15.2 Accessories .......................................................................................................104
15.2.1 Flow sensor cable................................................................................................................. 104
15.2.2 Flow sensor ........................................................................................................................... 105
15.2.3 Exhalation membrane and membrane holder ................................................................. 107
16 Setting ranges and parameters ....................................................... 111
17 Guide to Volume Guarantee (VG) ..................................................... 115
17.1 fabian (VG) operation (Conventional ventilation) .............................................115
17.2 How to start the VG function.............................................................................116
17.3 Setting up the ventilator PSV+VG......................................................................119
18 Special procedures......................................................................... 120
18.1 Use of NO (Nitric Oxide) ....................................................................................120
19 Technical specifications ................................................................. 121
19.1 Ambient conditions........................................................................................... 121
19.2 Monitoring ........................................................................................................ 121
19.3 Measuring .........................................................................................................122
19.4 Resistance values.............................................................................................. 123
19.5 Ventilation menu settings.................................................................................123
19.6 Dimensions / weight .........................................................................................124
19.7 Ratings..............................................................................................................124
19.8 Data storage...................................................................................................... 125
19.9 Applied parts..................................................................................................... 125
19.10 Internal device checks ......................................................................................125
19.11 Gas blender function.........................................................................................125
19.12 Essential Performance ......................................................................................127
20 Electromagnetic compatibility statement ....................................... 129
20.1 Devices with SN from AN-04000 ........................................................................129
20.2 Devices with SN up to AN-03999 .......................................................................133
Appendix A: Glossary............................................................................................ 137
Appendix B: Index ................................................................................................ 139

1 Introduction 1
fabian +nCPAP evolution | SW V5.1.x
Ref: 122003.EN / Date : 26Jan2021
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.

2 1 Introduction
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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, refer to operator’s manual for important safety information and
precautions.
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 more than 2 on top.
DO NOT use hooks.
DO NOT use if package is damaged
DO NOT use when patient is connected to the device
Expiration date
Explosion Hazard warning
External power supply input
Flammability / Fire hazard warning.
Sensor
Flow sensor connection
Flow sensor connection.
2

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Symbol
Description
Fragile, Handle with care.
GHS Chemical Hazard warning
High Frequency interference warning.
Humidity Limitation
Keep away from heat.
Keep dry.
Manufactured without the use of natural latex or derivatives.
Manufacturer
Marking per Medical Devices Directive 93/42/EEC
Medical device
Nebulizer (obsolete)
Network Ethernet connection (disabled)
Non-Sterile
NOTE symbol
Nurse Call signal output.
Nurse Call signal output.
Potential equalisation connection.
Protective Earth ground.
Single use.
Storage Temperature
This way UP.
Type BF applied part.

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Ref: 122003.EN / Date : 26Jan2021
Symbol
Description
Type B applied part
Unplug power before opening housing.
Video Output
USB connection.
Warning regarding operation in explosive areas.

2 Warnings, cautions and notices 5
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2Warnings, cautions and notices
2.1 Always observe (fabian)
#
Symbol
Description
NOTE:The use of the ventilator requires detailed knowledge and the
understanding of this operator’s manual. This device is only intended for the
described use.
WARNING:Only use this ventilator in combination with an external
monitoring device (for example: SpO2).
WARNING:Only operate the ventilator with accessories recommended by
ACUTRONIC Medical Systems AG.
WARNING:The ventilator must be operated by qualified clinical staff to
ensure immediate remedial action in the event of malfunction.
WARNING: The fabian system and associated auxiliary systems must NEVER
be used in MRI scanning facilities.
WARNING:An alternate ventilation method (for example: manual
resuscitation) must always be available when using the ventilator.
WARNING: DO NOT use the ventilator in combination with flammable gases
or narcotic agents to prevent the risk of fire or explosion.
WARNING:NEVER use the ventilator in explosive environments.
WARNING:An audible signal indicates a system or patient alarm and always
requires action by a trained medical professional.
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.
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.
WARNING:DO NOT obstruct the speaker.
Blocking the speaker can result in an inaudible alarm tone.
WARNING:Carefully route patient cabling to reduce the risk of patient
entanglement or strangulation.
WARNING:NEVER connect the ventilator to a patient if an error or
malfunction is detected during equipment check.
WARNING:NEVER connect to electrical devices not mentioned in this
operator’s manual without first consulting the manufacturer.
WARNING:Connect only electrical devices which are IEC60601-1 approved.
WARNING:NEVER operate the ventilator while covered or set up in a way to
negatively impact the operation or function.

6 2 Warnings, cautions and notices
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#
Symbol
Description
WARNING:Always unplug the ventilator from the power source before
opening the housing.
WARNING:NEVER use anti-static or electrically conductive tubing.
NOTE: To support patient and operator safety, the fabian HFO does not
contain VOCs, CO, CO2, O3, and particulates emitted above hazardous
thresholds. Acute, subacute/subchronic, and chronic toxicity from the
exposure to these compounds from the intended use of this device are not
expected.
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.
WARNING:DO NOT modify the equipment.
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.
WARNING:When connected to a patient DO NOT simultaneously touch the
external power supply cord and the flow sensor connector cable.
WARNING:if the volume of the acoustic alarms is set less than the ambient
noise level this might impede an operator to recognize alarm conditions.
WARNING:NEVER cover the ventilator while in use.
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.
WARNING:in case of ventilator failure, the lack of immediate access to
appropriate alternative means of ventilation can result in patient death.
WARNING:Ensure that alarms are appropriately set before use of ventilator
on a patient.
WARNING:In case portions of the gas pathways through the VENTILATOR
become contaminated with body fluids or expired gases,immediately
contact ACUTRONIC Medical Systems.
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.

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#
Symbol
Description
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.
Before use, carefully read the following literature:
•Oximetry Sensor Directions for Use
•PC-Series Patient Cable Directions for Use.
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.
Check alarm limit settings each time the pulse oximeter is used.
A pulse oximeter should NOT be used as an apnea monitor.
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.
Always remove the sensor from the patient and completely disconnect the
patient from the pulse oximeter before bathing the patient.
DO NOT use malfunctioning equipment. Have the pulse oximeter unit
repaired by Masimo or a qualified service person.
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.
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.
WARNING:Only use air and O2hoses which are in accordance to the ISO 5359
standard
WARNING:DO NOT use the ventilator in association with HF (High Frequency)
electrosurgical equipment.
WARNING:Connect SpO2and etCO2sensor cables to the machine before the
patient is connected.

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2.2 Maintenance
The fabian +nCPAP evolution device is a ventilator classified as Class IIb (for prolonged use more
than 24 hours and less than 30 days) according to the European Medical Device 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.
ACUTRONIC Medical Systems AG representatives are strongly recommend for service
agreements and repairs.
Only use original ACUTRONIC Medical Systems parts for repairs.
Note chapter ”14: Ventilator service and 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.

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2.4 Intended use
The fabian +nCPAP evolution is intended for premature infants, new-borns as well as children
weighing up to 30 kg.
The fabian +nCPAP evolution is intended for “in-patient use” in professional healthcare
environment including intra-hospital patient transport.
The fabian +nCPAP evolution is an electronically microprocessor controlled ventilator.
The fabian +nCPAP evolution 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/O2blender.
The oxygen concentration is measured internally with a galvanic oxygen sensor.
The ventilator is intended for the following ventilation methods:
•CPAP Continuous positive airway pressure
•IPPV Intermittent Positive Pressure Ventilation (CMV Controlled Mandatory Ventilation)
•NIV ventilation nCPAP/duoPAP with variable flow generators
•PSV Pressure Support Ventilation
•SIMV + PSV Synchronised Intermittent Mandatory Ventilation combined with PSV
•SIMV Synchronised Intermittent Mandatory Ventilation
•SIPPV Synchronised Intermittent Positive Pressure Ventilation (A / C, Assist Controlled)
(Infant Flow®, Infant Flow LP®, InspireTM, Medijet®)
The equipment is operated by a physician or at their 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 +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 tubes
•One Power Cable (country specific)
•One Instructions for Use (country specific)
•NOTE: The duration of indirect patient contact is defined as prolonged (i.e. more than 24
hours and less than 30 days)
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
Inspiratory tube port
Connection for nCPAP system based on flow generators (Single limb systems)
Proximal pressure measuring tube port
Expiration port
4
3
1
2

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3.4 Rear panel
3.4.1 Devices without DC connector (from SN AN-04000)
Mains connection with fuse holder
Terminal stud for potential equalization
Nurse call connector, max switching voltage 30 VDC
Flow sensor connector
Network connection for data management (disabled)
USB connection for connection of a USB powered nebulizer. Also available when not
in clinical use for data output and software update.
RS232 interface, service, PDMS
Connection for compressed air supply 2.0 –6.0 bar / max 40 L/min
Connector for Masimo SpO2module
Oxygen sensor access cover
Connection for oxygen “O2” supply 2.0 – 6.0 bar / max 40 L/min
1
2
5
6
3
7
4
8
9
10
11

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3.4.2 Devices with DC connector (up to SN AN-03999)
Mains connection with fuse holder
Terminal studs for potential equalization
Connection for external voltage supply 12 –24V DC
With HW Rev. 1.0 use only with connection cable Part. No. 151401
Nurse call connector, max switching voltage 30 VDC
Flow sensor connector
Network connection for data management (disabled)
USB connection for data output, Software update. Connector for Masimo SpO2
module.
RS232 interface, service, PDMS
Connection for compressed air supply 2.0 –6.5 bar / max 40 L/min
Connection for future use, covered with a faceplate
Oxygen sensor
Connection for future use, covered with a faceplate
Connection for oxygen “O2” supply 2.0 – 6.5 bar / max 40 L/min
1
2
3
4
5
6
7
8
9
10
12
13
11