ACUTRONIC Fabian Therapy evolution Manual de usuario

Ref: 121003.EN / Date: 2018-06-18

Warning

Carefully read the instructions of

use before using the ventilator to

familiarise yourself with the function

of the equipment

Ventilation Beyond Limits

fabian Therapy evolution

Instructions for use

SW 5.0

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Ref: 121003.EN / Date: 2018-06-18

DISCLAIMER

ACUTRONIC Medical Systems assumes no responsibility for the use or reliability of its software on

equipment that is not furnished by ACUTRONIC Medical Systems.

ACUTRONIC Medical Systems makes no warranty of any kind with regard to software applications

that are created by the user.

This document contains confidential and proprietary information that is protected by copyright. All

rights are reserved. Any unauthorized copying, storage, reproduction or translation of this

document in any form is strictly prohibited.

Manufactured by:

ACUTRONIC Medical Systems AG

Fabrik im Schiffli

8816 Hirzel / Switzerland

Tel: +41 44 729 70 80

Fax: +41 44 729 70 81

e-mail: [email protected]

www.acutronic-medical.ch

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Ref: 121003.EN / Date: 2018-06-18 
Table of Contents 
 
1Working with the instructions........................................... 6 
1 Document Structure............................................................................................6 
2 Notices and Warnings ........................................................................................6 
3 Hardware Version Identification........................................................................7 
4 Symbols ...............................................................................................................7 
2General Notices................................................................. 9 
1 Always Observe ..................................................................................................9 
2 Maintenance ......................................................................................................11 
3 Liability for Functionality / Damages..............................................................11 
4 Intended use......................................................................................................11 
5 Scope of Delivery..............................................................................................12 
6 Contra-indications ............................................................................................12 
3System overview..............................................................13 
1 Front Connections ............................................................................................13 
2 Rear Panel..........................................................................................................14 
4Operation and Display .....................................................16 
1 Control options .................................................................................................16 
1.1 Buttons........................................................................................................................................... 17 
1.2 Rotary pulse knob........................................................................................................................... 17 
2 Display concept structure................................................................................18 
2.1 Display areas.................................................................................................................................. 18 
2.2 Display screen................................................................................................................................ 18 
2.3 Information bar............................................................................................................................... 19 
2.4 Numeric field / Alarm limits ............................................................................................................. 20 
2.5 Graphic field................................................................................................................................... 20 
2.6 LED Indicators................................................................................................................................ 21 
3 Ventilation Menu ...............................................................................................22 
3.1 Operation –General....................................................................................................................... 22 
3.2 Operation –Settings....................................................................................................................... 23 
3.3 Ventilation parameter dependency ................................................................................................. 24 
3.4 Locking ventilator parameters......................................................................................................... 24 
4 Graphics Menu..................................................................................................25 
4.1 Trend Menu.................................................................................................................................... 26 
5Preparing for Operation...................................................27 
1 Establish Power Supply ...................................................................................27 
2Establish Gas Supply .......................................................................................27 
3 Connect tube set...............................................................................................28 
4 Connect flow sensor in NIV trigger (optional) ...............................................29 
5 Switching On the device ..................................................................................29 
6 Switching Off the device ..................................................................................30 
6Device Check....................................................................31 
7Configurations Menu........................................................32 

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1 Calibration .........................................................................................................34 
1.1 Calibration Menu at Therapy (only with flow sensor connector) ...................................................... 34 
1.2 O2Sensor Calibration..................................................................................................................... 35 
1.3 Flow Sensor Calibration.................................................................................................................. 36 
1.4 SpO2Module.................................................................................................................................. 36 
2 Display ...............................................................................................................37 
2.1 Touch Screen Settings................................................................................................................... 38 
2.2 Trend / Graph Display..................................................................................................................... 38 
3 Ventilation parameter settings ........................................................................39 
3.1 Standard Hospital Settings ............................................................................................................. 40 
4 Patient Data .......................................................................................................41 
5 Language ...........................................................................................................41 
6 Date / Time.........................................................................................................42 
7 Tools...................................................................................................................42 
8 Info 43 
9 Service Mode.....................................................................................................43 
8Alarm Limits Menu ...........................................................44 
1 Automatic Alarm Limits....................................................................................46 
1.1 Alarm Conditions............................................................................................................................ 46 
1.2 Automatic Alarm Presets................................................................................................................ 46 
2 Alarm Log ..........................................................................................................47 
3 Nurse call relay..................................................................................................47 
9Battery Operation............................................................48 
1 Power Failure.....................................................................................................49 
2 Operating on External Power Source .............................................................49 
Function Fields –Ventilation Parameters.........................50 
Ventilation Modes............................................................51 
1 nCPAP / duoPAP...............................................................................................51 
2 O2Therapy mode (High and Low flow oxygen therapy) HFNC ....................52 
3 Special Functions .............................................................................................52 
3.1 Manual inspiration (man. Breath).................................................................................................... 52 
3.2 O2Flush / Preoxygenation.............................................................................................................. 52 
3.3 Standby –stopping / pausing mechanical ventilation...................................................................... 53 
Error –Cause –Solution –Alarms.....................................54 
1 Application error ...............................................................................................57 
Replacing the Oxygen Sensor...........................................58 
Service and Maintenance Intervals ..................................59 
Sterilisation / Cleaning / Disinfection...............................60 
Setting Ranges and Parameters.......................................61 
Standard Accessories.......................................................62 
Technical Specifications ..................................................63 

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1 Ambient Conditions..........................................................................................63 
2 Monitoring..........................................................................................................63 
3 Measuring ..........................................................................................................64 
4 Settings in Ventilation Menu............................................................................64 
5 Dimensions / Weight.........................................................................................64 
6 Ratings...............................................................................................................65 
7 Data storage ......................................................................................................66 
8 Applied Parts.....................................................................................................66 
9 Device Checks...................................................................................................66 
10 Gas blender function........................................................................................67 
11 Acoustic Energy................................................................................................68 
Electromagnetic Compatibility Statement.......................69 
 

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Ref: 121003.EN / Date: 2018-06-18

1 Working with the instructions

1.1 Document Structure

The left side of the page …

… displays explanations, instructions and detailed description on the topic or procedure.

The right side of the page …

… displays the graphic representations, operating elements and displays belonging to the

description and guides the user through any handling steps.

These instructions for use describe equipment components and their operation. It is laid out such

that you can step by step become familiar with operation of the ventilator.

Please carefully read the instructions for use before using the ventilator.

Once you are familiar with the basic construction and operation of the ventilator you may use the

instructions for use as a reference.

The table of contents will assist you in quickly locating the respective topic.

1.2 Notices and Warnings

This document features 3 categories of notices and warnings.

NOTICES are supplements to instructions

Danger

DANGER indicates a not directly imminent but latent hazard which may result in

death or bodily injury unless prevented.

ATTENTION indicates a risk which may result in equipment damage when not

avoided.

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Ref: 121003.EN / Date: 2018-06-18

1.3 Hardware Version Identification

The hardware version can be identified from the device serial number.

Serial number: xxyyxx-nnnn, yy = Hardware version

From 1st of January 2016 the serial number has been changed to AT-xxxxx

The reason for it is,that the HW revision is only valid when leaving the factory.

1.4 Symbols

Symbol

Description

VDC 12 –24V 4A

External power supply input

USB connection

Network connection RJ45

Connection for external trigger

Opt.1

Optional connector

Data input / Data output RS232

Nurse call signal output

Caution, refer to operator’s manual for important safety information / precautions

Flow sensor connection

Potential equalisation connection

Marking per Medical Devices Directive 93/42/EEC

Manufacturer / Date of manufacture

Disposal information

Type B application part

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Symbol

Description

Unplug power before opening housing

Flammability warning

Warning regarding operation in explosive areas

Dangerous voltage warning

Do not cover

Protect from moisture

Chemical burn warning

Batch code

Single use

Article No.

Non-sterile

Latex free

Fragile, handle with care

Keep away from heat

Keep dry

This way up

Do not use hooks

Do not stack

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Ref: 121003.EN / Date: 2018-06-18

2 General Notices

2.1 Always Observe

The use of the ventilator requires detailed knowledge and the observation of this

operator’s manual. This device is only intended for the described use.

Only operate the ventilator with accessories recommended by ACUTRONIC

Medical Systems AG.

The ventilator must be operated by qualified technical staff or staff supervised by

such to ensure immediate remedial action in the event of malfunction.

An alternate ventilation method (e.g. Resuscitator) must be available at all times

when using the ventilator.

If the life-support function is no longer warranted due to a noticeable ventilator

defect, the patient must immediately be artificially ventilated using a stand-alone

ventilator (e.g. Resuscitator).

The ventilator may not be used in combination with inflammable gases or narcotic

agents –there is otherwise an acute risk of fire and explosion!

Never use the ventilator in explosive environments!

An audible signal indicates a system or patient alarm and always requires action

by a medical professional.

Never connect the ventilator to patients if an error or malfunction is detected

during equipment check!

Never connect to electrical devices not mentioned in this operator’s manual

without first consulting the manufacturer or an expert.

Never operate the ventilator while covered or set up in a way so as to negatively

impact the operation or function.

Always unplug before opening the housing!

Never use anti-static or electrically conductive tubes.

Note: the safety and health of the users is guaranteed by the fact that the

products for example do not contain any allergenic or mutagenic materials such

as phthalates.

10 / 72 fabian Therapy evolution | SW 5.0

Ref: 121003.EN / Date: 2018-06-18

The device can only be separated from the main power supply by removing the

power cord completely. Please ensure the power socket is freely accessible at all

times for disconnection. Do not remove the power cable unless for service

purposes or transport.

Warning: modification of this equipment is not allowed.

Note: accessories supplied by ACUTRONIC Medical Systems AG for use on

fabian ventilators are biocompatible. Please ensure before applying non-original

accessories that they are biocompatible.

Warning: when connected to a patient do not simultaneously touch the external

power supply and the flow sensor connector cable.

Warning: if the strength of the auditory alarms are less than the ambient sound

this might impede an operator to recognize alarm conditions.

Warning: please ensure that the ventilator is never covered.

Warning: please ensure that the ventilator is never positioned in such a way that

the performance of the ventilator is adversely affected.

Warning: in case of ventilator failure, the lack of immediate access to appropriate

alternative means of ventilation can result in patient death.

Warning: please ensure that alarms are set appropriately prior to use of ventilator

on patient.

Warning: be sure that the gas intake ports are not obstructed

Warning: do not use the fabian in an oxygen-rich environment

Warning: in case portions of the gas pathways through the VENTILATOR can

become contaminated with body fluids or expired gases during NORMAL

CONDITION or SINGLE FAULT CONDITION, please contact ACUTRONIC

Medical Systems.

Warning: only use air and O2hoses which are in accordance to the ISO 5359

standard

Warning: this VENTILATOR is a high flow device and should only be connected to

a pipeline installation that allows the indicated flow

Warning: this VENTILATOR shall not be used with nitric oxide

Warning: only use this ventilator in combination with an external monitoring (e.g

SpO2) device

Otros manuales para fabian Therapy evolution

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Otros manuales de Equipo médico de ACUTRONIC

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ACUTRONIC fabian +nCPAP evolution Manual de usuario

ACUTRONIC

ACUTRONIC fabian HFO Manual de usuario

ACUTRONIC

ACUTRONIC fabian Manual de usuario

ACUTRONIC

ACUTRONIC fabian Therapy evolution Manual de usuario

ACUTRONIC

ACUTRONIC fabian HFO Manual de usuario

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