ACUTRONIC Fabian +nCPAP evolution Manual de usuario

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: +41 44 729 70 80

Fax: +41 44 729 70 81

e-mail: info@acutronic-medical.ch

www.acutronic-medical.ch

For any additional parts and accessories, contact your local distributor for available items and

price list.

ii Table of Contents 
 
fabian +nCPAP evolution | SW V5.1.x 
Ref: 122003.EN / Date : 26Jan2021 
Table of Contents 
 
Disclamer ................................................................................................ i 
Table of Contents.................................................................................... ii 
1Introduction ...................................................................................... 1 
1 Working with the instructions .............................................................................. 1 
2 Notices and warnings ........................................................................................... 1 
3 Applicable product versions................................................................................. 1 
4 Symbols................................................................................................................ 2 
2Warnings cautions and notices ........................................................... 5 
1 Always observe (fabian)........................................................................................ 5 
2 Maintenance......................................................................................................... 8 
3 Liability for functionality / damages .................................................................... 8 
4 Intended use......................................................................................................... 9 
3System overview ............................................................................. 10 
1 Scope of delivery ................................................................................................ 10 
2 Contraindications............................................................................................... 10 
3 fabian Front connections ................................................................................... 10 
4 Rear panel .......................................................................................................... 11 
4.1 Devices without DC connector (from SN AN-04000) ...........................................................11 
4.2 Devices with DC connector (up to SN AN-03999) ................................................................12 
4.3 General hardware characteristics .........................................................................................13 
4System functions and displays ......................................................... 14 
1 Control panel options......................................................................................... 14 
1.1 Function buttons.....................................................................................................................14 
1.2 Rotary push knob ....................................................................................................................15 
2 Display concept structure .................................................................................. 16 
2.1 Display areas............................................................................................................................16 
2.2 Display screen..........................................................................................................................16 
2.3 Information bar ......................................................................................................................17 
2.4 Numeric field / Alarm limits ...................................................................................................18 
2.5 Graphic field.............................................................................................................................20 
2.6 LED Indicators..........................................................................................................................20 
3 Ventilation menu................................................................................................ 21 
3.1 Operation –General................................................................................................................21 
3.2 Operation –Settings ...............................................................................................................22 
3.3 Ventilation parameter dependency ......................................................................................23 
3.4 Locking ventilator parameters ..............................................................................................23 
4 Graphics menu ................................................................................................... 25 
4.1 Waves........................................................................................................................................26 

Table of Contents iii 
 
fabian +nCPAP evolution | SW V5.1.x 
Ref: 122003.EN / Date : 26Jan2021 
4.2 Loops ....................................................................................................................................... 27 
4.3 Trend Menu ............................................................................................................................. 28 
5System operation .............................................................................29 
1 Preparing for operation ......................................................................................29 
1.1 Connect the power supply .................................................................................................... 29 
1.2 Connect the gas supply ......................................................................................................... 29 
1.3 Connect the tubing set .......................................................................................................... 30 
2 Patient circuit assembly .....................................................................................31 
2.1 Recommended positioning of temperature probe for humidifier ................................... 32 
2.2 Use of dual limb patient circuit ............................................................................................ 33 
2.3 Connect nCPAP tubing .......................................................................................................... 35 
2.4 Triggering in DUOPAP mode with flow sensor (optional).................................................. 35 
3 System start-up ..................................................................................................36 
4 Device check .......................................................................................................38 
5 System standby / pause......................................................................................40 
6 System shutdown ...............................................................................................41 
7 Emergency shutdown .........................................................................................42 
6Configurations menu........................................................................43 
1 Calibration ..........................................................................................................44 
1.1 Flow sensor ............................................................................................................................. 45 
1.2 O2Sensor ................................................................................................................................ 47 
1.1 SpO2module .......................................................................................................................... 48 
2 Body weight setting ............................................................................................48 
3 Display ................................................................................................................48 
3.1 Touch screen settings............................................................................................................ 49 
3.2 Trend / graph display............................................................................................................. 50 
4 Ventilation parameter settings ...........................................................................51 
5 Patient data ........................................................................................................53 
6 Language ............................................................................................................54 
7 Date / Time .........................................................................................................54 
8 Tools ...................................................................................................................55 
9 Information.........................................................................................................55 
10 Service mode ......................................................................................................56 
7Alarms .............................................................................................57 
1 Alarm limits menu...............................................................................................57 
1.1 Automatic alarm limits .......................................................................................................... 59 
1.2 Configurable alarms............................................................................................................... 60 
2 Alarm log.............................................................................................................60 
3 Nurse call relay ...................................................................................................60 
4 Alarm causes and solutions ................................................................................61 
4.1 Alarms table ............................................................................................................................ 61 
4.2 Pressure release behaviour................................................................................................... 68 

iv Table of Contents 
 
fabian +nCPAP evolution | SW V5.1.x 
Ref: 122003.EN / Date : 26Jan2021 
4.3 Application error .....................................................................................................................68 
4.4 Watchdog alarms ....................................................................................................................69 
8Battery operation ............................................................................ 70 
1 Power failure ...................................................................................................... 71 
9Operating on external power source................................................. 72 
1 (Devices with SN up to AN-03999) ...................................................................... 72 
Ventilation parameters .................................................................... 73 
Ventilation modes............................................................................ 76 
1 IPPV .................................................................................................................... 77 
2 SIPPV .................................................................................................................. 78 
3 SIMV.................................................................................................................... 79 
4 SIMV + PSV .......................................................................................................... 80 
5 PSV ..................................................................................................................... 81 
6 CPAP ................................................................................................................... 81 
7 NCPAP / DUOPAP................................................................................................ 82 
8 O2Therapy mode............................................................................................... 83 
8.1 (high and low flow oxygen therapy) HFNC ...........................................................................83 
9 Ventilation Additives .......................................................................................... 83 
9.1 Volume limit.............................................................................................................................83 
9.2 Volume guarantee...................................................................................................................84 
10 Special functions................................................................................................ 84 
10.1 Manual inspiration (manual Breath).....................................................................................84 
10.2 Nebulizing medications (optional)........................................................................................85 
10.3 O2Flush / preoxygenation .....................................................................................................85 
Accessories and options................................................................... 86 
1 Accessories List .................................................................................................. 86 
2 Spare parts list ................................................................................................... 88 
3 SpO2module...................................................................................................... 89 
3.1 Setting up the Masimo sensor ...............................................................................................89 
3.2 Sensitivity mode......................................................................................................................90 
3.3 Fast SAT mode.........................................................................................................................90 
3.4 Alarm delay ..............................................................................................................................91 
3.5 SpO2averaging time...............................................................................................................91 
4 PRICO ................................................................................................................. 92 
4.1 General information on PRICO ..............................................................................................92 
4.2 Setting up PRICO .....................................................................................................................94 
4.3 PRICO Ventilation modes .......................................................................................................96 
4.4 PRICO disabling alarms ..........................................................................................................97 
4.5 PRICO re-enabling cases ........................................................................................................97 
4.6 PRICO errors.............................................................................................................................97 
5 External communication, PDMS ......................................................................... 99 

Table of Contents v 
 
fabian +nCPAP evolution | SW V5.1.x 
Ref: 122003.EN / Date : 26Jan2021 
Replacing the oxygen sensor........................................................... 100 
Ventilator service and maintenance intervals.................................. 101 
1 Disposal ............................................................................................................102 
Sterilization / cleaning / disinfection............................................... 103 
1 fabian +nCPAP evolution ..................................................................................103 
1.1 Preparation for disinfection ................................................................................................ 103 
1.2 Manual disinfection options ............................................................................................... 103 
2 Accessories .......................................................................................................104 
2.1 Flow sensor cable................................................................................................................. 104 
2.2 Flow sensor ........................................................................................................................... 105 
2.3 Exhalation membrane and membrane holder ................................................................. 107 
Setting ranges and parameters ....................................................... 111 
Guide to Volume Guarantee (VG) ..................................................... 115 
1 fabian (VG) operation (Conventional ventilation) .............................................115 
2 How to start the VG function.............................................................................116 
3 Setting up the ventilator PSV+VG......................................................................119 
Special procedures......................................................................... 120 
1 Use of NO (Nitric Oxide) ....................................................................................120 
Technical specifications ................................................................. 121 
1 Ambient conditions........................................................................................... 121 
2 Monitoring ........................................................................................................ 121 
3 Measuring .........................................................................................................122 
4 Resistance values.............................................................................................. 123 
5 Ventilation menu settings.................................................................................123 
6 Dimensions / weight .........................................................................................124 
7 Ratings..............................................................................................................124 
8 Data storage...................................................................................................... 125 
9 Applied parts..................................................................................................... 125 
10 Internal device checks ......................................................................................125 
11 Gas blender function.........................................................................................125 
12 Essential Performance ......................................................................................127 
Electromagnetic compatibility statement ....................................... 129 
1 Devices with SN from AN-04000 ........................................................................129 
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

fabian +nCPAP evolution | SW V5.1.x

Ref: 122003.EN / Date : 26Jan2021

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.

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.

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