ACUTRONIC Ventilation Beyond Limits Instruction

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: info@acutronic-medical.ch

www.acutronic-medical.ch

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Table of Contents

1 Working with the instructions ........................................... 6

1.1 Document Structure............................................................................................ 6

1.2 Notices and Warnings ........................................................................................ 6

1.3 Hardware Version Identification ........................................................................ 7

1.4 Symbols ............................................................................................................... 7

2 General Notices ................................................................. 9

2.1 Always Observe .................................................................................................. 9

2.2 Maintenance ...................................................................................................... 11

2.3 Liability for Functionality / Damages .............................................................. 11

2.4 Intended use ...................................................................................................... 11

2.5 Scope of Delivery .............................................................................................. 12

2.6 Contra-indications ............................................................................................ 12

3 System overview .............................................................. 13

3.1 Front Connections ............................................................................................ 13

3.2 Rear Panel .......................................................................................................... 14

4 Operation and Display ..................................................... 16

4.1 Control options ................................................................................................. 16

4.1.1 Buttons ........................................................................................................................................... 17

4.1.2 Rotary pulse knob ........................................................................................................................... 17

4.2 Display concept structure ................................................................................ 18

4.2.1 Display areas .................................................................................................................................. 18

4.2.2 Display screen ................................................................................................................................ 18

4.2.3 Information bar ............................................................................................................................... 19

4.2.4 Numeric field / Alarm limits ............................................................................................................. 20

4.2.5 Graphic field ................................................................................................................................... 20

4.2.6 LED Indicators ................................................................................................................................ 21

4.3 Ventilation Menu ............................................................................................... 22

4.3.1 Operation – General ....................................................................................................................... 22

4.3.2 Operation – Settings ....................................................................................................................... 23

4.3.3 Ventilation parameter dependency ................................................................................................. 24

4.3.4 Locking ventilator parameters ......................................................................................................... 24

4.4 Graphics Menu .................................................................................................. 25

4.4.1 Trend Menu .................................................................................................................................... 26

5 Preparing for Operation ................................................... 27

5.1 Establish Power Supply ................................................................................... 27

5.2 Establish Gas Supply ....................................................................................... 27

5.3 Connect tube set ............................................................................................... 28

5.4 Connect flow sensor in NIV trigger (optional) ............................................... 29

5.5 Switching On the device .................................................................................. 29

5.6 Switching Off the device .................................................................................. 30

6 Device Check .................................................................... 31

7 Configurations Menu ........................................................ 32

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7.1 Calibration ......................................................................................................... 34

7.1.1 Calibration Menu at Therapy (only with flow sensor connector) ...................................................... 34

7.1.2 O2 Sensor Calibration ..................................................................................................................... 35

7.1.3 Flow Sensor Calibration .................................................................................................................. 36

7.1.4 SpO2 Module .................................................................................................................................. 36

7.2 Display ............................................................................................................... 37

7.2.1 Touch Screen Settings ................................................................................................................... 38

7.2.2 Trend / Graph Display..................................................................................................................... 38

7.3 Ventilation parameter settings ........................................................................ 39

7.3.1 Standard Hospital Settings ............................................................................................................. 40

7.4 Patient Data ....................................................................................................... 41

7.5 Language ........................................................................................................... 41

7.6 Date / Time ......................................................................................................... 42

7.7 Tools ................................................................................................................... 42

7.8 Info 43

7.9 Service Mode ..................................................................................................... 43

8 Alarm Limits Menu ........................................................... 44

8.1 Automatic Alarm Limits .................................................................................... 46

8.1.1 Alarm Conditions ............................................................................................................................ 46

8.1.2 Automatic Alarm Presets ................................................................................................................ 46

8.2 Alarm Log .......................................................................................................... 47

8.3 Nurse call relay .................................................................................................. 47

9 Battery Operation ............................................................ 48

9.1 Power Failure ..................................................................................................... 49

9.2 Operating on External Power Source ............................................................. 49

10 Function Fields – Ventilation Parameters ......................... 50

11 Ventilation Modes ............................................................ 51

11.1 nCPAP / duoPAP ............................................................................................... 51

11.2 O2 Therapy mode (High and Low flow oxygen therapy) HFNC .................... 52

11.3 Special Functions ............................................................................................. 52

11.3.1 Manual inspiration (man. Breath) .................................................................................................... 52

11.3.2 O2 Flush / Preoxygenation .............................................................................................................. 52

11.3.3 Standby – stopping / pausing mechanical ventilation ...................................................................... 53

12 Error – Cause – Solution – Alarms ..................................... 54

12.1 Application error ............................................................................................... 57

13 Replacing the Oxygen Sensor ........................................... 58

14 Service and Maintenance Intervals .................................. 59

15 Sterilisation / Cleaning / Disinfection ............................... 60

16 Setting Ranges and Parameters ....................................... 61

17 Standard Accessories ....................................................... 62

18 Technical Specifications .................................................. 63

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18.1 Ambient Conditions .......................................................................................... 63

18.2 Monitoring .......................................................................................................... 63

18.3 Measuring .......................................................................................................... 64

18.4 Settings in Ventilation Menu ............................................................................ 64

18.5 Dimensions / Weight ......................................................................................... 64

18.6 Ratings ............................................................................................................... 65

18.7 Data storage ...................................................................................................... 66

18.8 Applied Parts ..................................................................................................... 66

18.9 Device Checks ................................................................................................... 66

18.10 Gas blender function ........................................................................................ 67

18.11 Acoustic Energy ................................................................................................ 68

19 Electromagnetic Compatibility Statement ....................... 69

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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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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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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.

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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 O2 hoses 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

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2.2 Maintenance

This device is a ventilator classified as Class IIb according to the European directive, as such:

• Inspection as per manufacturer specifications is required every 12 months.

• Maintenance must be performed by ACUTRONIC trained experts with access to

appropriate test and measuring equipment.

We strongly recommend ACUTRONIC Medical Systems AG exclusive representatives for service agreements and repairs.

Only use original ACUTRONIC parts for repairs.

Note chapter “14. Service and Maintenance Intervals”

Original packaging should be kept for the possible return of the unit. Only original packaging ensures optimal protection of the equipment during transport. If it is necessary to return the equipment during the warranty period, the manufacturer is not liable for damages caused by incorrect packaging.

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 support 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 nonobservance of preceding notices. The preceding notices do not extend the warranty and liability terms of the ACUTRONIC Medical Systems AG sales terms and delivery conditions.

2.4 Intended use

The fabian Therapy evolution is intended for premature infants, new-borns as well as children weighting up to 30 kg.

The fabian Therapy evolution is intended for “in-patient use” in hospitals, medically-used rooms and intra-hospital patient transport.

The fabian Therapy evolution is an electronically microprocessor controlled ventilator. The fabian Therapy evolution ventilates with excess pressure based on the continuous-flow principle. (Time cycled and pressure limited) Oxygen is metered by the integrated Air/O2 blender. The oxygen concentration is measured internally with a galvanic oxygen sensor.

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The ventilator is intended for the following, non invasive, ventilation methods:

• O2 Therapy

• NIV ventilation nCPAP/duoPAP with variable flow generators

(Infant Flow®, Infant Flow LP®, InspireTM, Medijet®

The equipment is operated by a physician or at his orders by a professional with technical training in this task, where up on any user must be trained on this equipment and familiar with the operator’s manual and the use of the equipment.

The fabian Therapy evolution is not approved for use in a homecare environment.

2.5 Scope of Delivery

This product includes the following items:

• 1 x fabian Therapy evolution ventilator (#121001)

• 2 x Infant flow connecting tube (#1530010.01)

• 1 x Power cable (# country specific)

• 1 x Operating manual (# country specific)

2.6 Contra-indications

No contra-indications for the use of the fabian Therapy evolution neonatal and infant ventilator in an intensive care unit are known.

In the event of ventilation for more than several hours, care must be taken for optimal conditioning of the respiratory gases (warmth, moisture) to guarantee secretion mobilization and prevent damage to mucous membranes.

In general, it should be noted with regard to contra-indications that ventilation of children should only be carried out by clinically trained specialists who have sufficient knowledge of ventilation at this age.

Detailed studies and experience can be requested from the following address:

ACUTRONIC Medical Systems AG

Fabrik im Schiffli 8816 Hirzel / Switzerland Tel: +41 44 729 70 80 Fax: +41 44 729 70 81 Email: info@acutronic-medical.ch

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3 System overview

3.1 Front Connections

Connection for fresh gas

Pressure measuring tube port

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3.2 Rear Panel

Mains connection with fuse holder

Terminal stud 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, max. Switching voltage 50 VDC

Covered with a faceplate / Flow sensor connector (from SN AT-03001)

Network connection for data management (For connection to network with minimum 3 KV galvanic isolation)

USB connection for data output (log file), software update. Connection for Masimo SpO2 module.

RS232 interface, service, PDMS

Connection for compressed air supply 2.0 – 6.5 bar / 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 / 40 l/min

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For Adapter to DISS see “17. Standard Accessories”

Warning: Do not connect Ethernet, Nurse call, USB, R232 ports to anything other than specified devices.

The PIN for the Potential Equalisation is there for additional safety and can be connected to an equipotential zone. Please adhere to local guidelines when using this PIN. The guidelines may vary between countries, localities and power companies. Always keep the PIN for Potential equalisation accessible.

Maximum Connected Loads:

Nurse call: Galvanically isolated relay output. max Load: 30 V / 1 A DC or AC USB: 5 V/150 mA RS232: 3.3 V/100 mA

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4 Operation and Display

4.1 Control options

The control panel features two key elements:

1. The display (Touch Screen) allows the direct control of the ventilator parameters by tapping defined buttons on the graphic user interface.

2. Fields in the lower section of the touch screen are operated with the buttons underneath.

3. The button /-control panel incremental knob (combined with a push button and selection dial)

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4.1.1 Buttons

The key pad features 2 rows of buttons with various functions.

Manual breathing

Used to apply a manual breath. Available in all the ventilation modes.

O2 Flush

Used to start O2 flush. Flush concentration and time can be preset.

Cursor buttons

These buttons serve as control in several menus.

Screen contrast setting

Used to adjust the brightness of the screen.

Menu / Calibration

Used to access the configuration and calibration menus. Pressing once will open the calibration menu; pressing again will open the configuration menu.

Waves

Switches to Waves display and values are shown in big letters.

Home

Displays the main screen for selecting the respiration mode.

Alarm limits

Switches to the alarm limits configuration.

On / off – start / stop

For switching the device on and off, stopping and resuming ventilation.

Alarm Mute

For acknowledging and muting alarms for a maximum duration of 120 seconds. Subsequent alarms with higher priority are only displayed optically during muting.

4.1.2 Rotary pulse knob

The rotary pulse knob combines a push button with a rotary knob for executing various settings, selections and confirmation options.

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4.2 Display concept structure

4.2.1 Display areas

The information system features 2 key display areas:

1. The touch screen

2. LED indicators

4.2.2 Display screen

The display screen shows various information, setting and display fields depending on the display settings or menu:

1. Info bar indicating battery status, time/date, status information, system and alarm information and ventilation mode

2. Pressure graph

3. Parameter setting field

4. Selection or display of operating mode

5. Numeric field / alarm limits

Depending on the display mode selected, individual fields may be shown/hidden.

Display field options will be described later.

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4.2.3 Information bar

The Info bar displays from general information to displaying alarms. It is divided into 3 sections.

The Info bar indicates the following among other things:

1. Patient data available Nurse call active / inactive Battery charge status

2. Ventilation mode, info and alarm display

3. Alarm Mute (time remaining until alarm reactivates) Time / date

The patient symbol indicates patient data associated with the current ventilator operation is saved to the device.

The nurse indicates Nurse Call is activated

Ventilation mode / Info / and Alarm display

Displays ventilation mode and, if applicable, additional current information and notices. A red blinking info bar also alerts the user to active alarms.

If screen lock is in use, the symbol for locked screen is displayed.

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4.2.4 Numeric field / Alarm limits

The numeric field are showing all measured values

In the numeric field the selected ventilation mode related measured values are displayed.

There can be multiple pages of numeric fields. To go to the next page, press the button underneath the numeric field.

Depending on the ventilation mode the data is updated as average/minute or by breath.

Numeric field

The upper and lower limits can be manually or automatically adjusted in the alarm limits menu.

To adjust the alarm limit manually:

• press the alarm limits button

• touch the parameter you wish to change

• the button turns from dark blue to green

• with rotary pulse knob, change the value

• to confirm the setting, either touch

parameter button again, or push rotary pulse knob again.

To automatically set the alarm limits, select parameter and touch AUTOSET button.

Alarm limits

4.2.5 Graphic field

The button Waves enlarges the measured values

Displays the current values in big letters and also the actual Wave

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4.2.6 LED Indicators

LED Indicator explanation

Warning LED

This LED will light or blink red when a system alarm is triggered.

LED Alarm Mute

This LED lights up in yellow when the alarm is muted. The remaining time for the alarm muting is displayed on the screen.

Battery LED

This LED will light yellow in battery operation and green when the battery is fully charged. The LED will blink green when the battery is charging.

Mains LED

This LED will light green in mains operation, and will switch off in battery operation.

During voltage supply via the external 12 - 24 VDC connection the mains LED are

not illuminated.

Battery LED flashes in green when the battery is being charged.

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4.3 Ventilation Menu

4.3.1 Operation – General

Push buttons and their statuses are indicated by various colours:

1 light blue: Push button

2 dark blue: focused push button

3 yellow (in functions menu): parameters

metered

4 green: selected push button, if the push

button features a parameter for setting a value it may now be changed.

Depending on the ventilation mode, the respiration menu indicates the configuration parameters (4) and measurements (5) relevant in this mode.

The Info bar (1) indicates current information.

The ventilation parameters may be changed in the menu (5).

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4.3.2 Operation – Settings

Settings

The ventilation parameters may be set before starting/activating ventilation mode:

1 Tap 1x the desired ventilation mode pre-

setting is activated

2 The configuration parameters for the

preselected ventilation mode may now be adjusted

3 Tap ventilation mode again: key will turn

green, ventilation will start with the defined parameter settings. The selected parameter may also be confirmed by pressing the rotary knob.

If the setting is active (yellow button) and no action is taken for 15 seconds, or the preselected mode is not confirmed by tapping again, the device will continue in the previous mode, new pre-settings are deleted.

After confirming a preselected parameter the audible alarm is automatically suppressed for 15 seconds. The audible alarm may be immediately activated by pressing the Alarm Mute button.

Press any blank area or another parameter to not accept the parameter and keep the previous value

Old active alarms at the time the mode is switched will automatically be reset.

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4.3.3 Ventilation parameter dependency

If parameters are mutually regulating, an arrow will appear on the parameter that needs to be modified. The arrow shows in which direction the modification has to be done.

List of dependencies:

• O2 Flush min. 2 Vol% above O2 setting, max. 100 Vol%

• P

DUO

min 2 mbar over PEEP

• Pmanuell min 2 mbar over CPAP

• Rise-time ≤ I-Time

4.3.4 Locking ventilator parameters

Some ventilator parameters are “locked” to prevent unusual high values.

When this value is reached a key symbol will appear and a notice signal will sound.

The high value must be confirmed by pressing the rotary knob again. (see table below)

List of locked values

Parameter

Locking at

Modes

I-Time

I : E > 1

DUOPAP

Frequenz

I : E > 1

DUOPAP

Flow

> 5 l/min

O2 Therapy

CPAP

> 10 mbar

DUOPAP / NCPAP

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4.4 Graphics Menu

The graphics menu may be accessed via the waves key on the keypad.

The graphics menu

Displays the current values in big letters and shows also the pressure wave.

Use “waves” to access the big screen menu.

The button underneath “Freeze” stops waves being updated. The key will turn green.

The measured parameters in the display field continue being updated.

Press the key again to continue updating the Waves data.

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4.4.1 Trend Menu

The device trend function automatically saves an average of measurements every 30 seconds. Measurements of up to 5 days can be recorded. Trend data is automatically deleted in the following cases:

• Date and / or time is modified

• New patient data is entered

• Software update

A confirmation message will always be displayed before trend data is deleted.

1. Parameter selection for graphic waves

2. Graphics

3. Parameter values

4. Timeline

5. Adjust timeline (max. 5 days – min. 30 minutes)

6. Update data (refresh)

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5 Preparing for Operation

5.1 Establish Power Supply

Connect the device with power cable to a suitable power socket.

Do not connect the device to a power outlet strip. Exception: the power outlet strip has been expressly approved by the manufacturer for connection to a ventilator.

The device can be operated with 100 VAC to 240 VAC and automatically adjusts to particular voltage without manual switch-over being necessary.

The used fuses must correspond with the value and type approved for the fabian. The particular fuse type and value is printed on the back of the fabian. Replacement of the fuses may only be carried out by trained staff. Please replace fuses with identical values, failing to do so, might cause fire hazards.

WARNING: To avoid risk of electric shock, this equipment must only be connected to a mains supply with protective earth.

5.2 Establish Gas Supply

Connect the compressed air and oxygen supply tube to the central gas supply.

If there is no central gas supply, gas supply from cylinders is also possible.

The inputs are coded to prevent wrong connection.

Input pressure 2 – 6.5 bar for Oxygen and Medical grade AIR (dust-free, oil-free and dry).

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5.3 Connect tube set

Never use anti-static or electrically conductive tubes.

The pressure gradient on the ventilation system of the ventilator measured on the patient connection port may increase when accessories or other components are attached to the ventilation system.

Preparing the nCPAP tubing system

• Connect nCPAP adapter to the fabian nCPAP port. (1)

• Connect 22 mm adapter connector to humidifier chamber.

• Connect nCPAP system pressure measuring tube to fabian port marked prox. (2)

• Connect nCPAP system to humidifier chamber.

• Apply nCPAP system to patient per manufacturer specifications.

For details of using nCPAP systems, refer to the operators manual of the supplier of the consumables.

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5.4 Connect flow sensor in NIV trigger (optional)

Preparing the nCPAP InfantFlow/InfantFlowLP/Inspire tubing system

• Connect flow sensor with an adapter to

exhalation tube as shown in the picture

Recommendation:

• Please use the exhalation tube as short as

possible

5.5 Switching On the device

Use the ON / OFF button on fabian Therapy evolution to switch on the device.

When the device is powered on the start-up screen will appear and the equipment will perform a self-test.

The SOFTWARE REVISION, the CHECK SUMS and the status of the interfaces will be checked.

(ok ≙ no error)

The O2 will be automatically calibrated after start up. After that every 24 hours. Can be also done manually after opening O2 sensor menu.

All audible alarms are silenced for 2 Minutes after startup of fabian.

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5.6 Switching Off the device

Disconnect patient.

Use the start/stop button on fabian Therapy evolution to switch off the device.

Hold start/stop button until the equipment is switched off.

Once the device has powered off a notice tone will sound.

Press the “Alarm Mute” button to confirm system switch off.

Hold the button for at least 3 seconds until the WARNING LED stops.

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6 Device Check

Always perform an equipment check before each ventilator use!

What

How

Target

Gas supply

Attach high pressure air and oxygen supply hoses on the rear side of the ventilator. Connect with corresponding wall outlets

Air and oxygen supply hoses are correctly connected

Breathing system

Tubes Water traps (if needed) Respiratory Humidifier and tube heating

Patient circuit assembled correctly as per manufacturer’s instructions

Switch on test

Switch on fabian Alarm tone (loudspeaker)

Self-test successful Alarm tone audible during switch-on test. (2 beeps)

Calibration

O2 sensor automatic calibration

Calibration successful

Leakage test

Start nCPAP mode CPAP 5 mbar P manual 15 mbar

Press button manual insp.

Pressure of 15 ± 2 mbar is achieved Disconnection

alarm

Disconnect patient supply line from the device Reconnect the tube.

Warning: disconnected will appear after the set delay.

Battery

Unplug power cord Reconnect power cord

fabian will automatically switch to battery mode

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7 Configurations Menu

The configuration menu can be accessed by pressing the Menu / Calibration key on the keypad. Depending on the HW state of the device the configuration menu can contain the sensor related submenus too.

Configuration menu in Therapy with flow sensor connector

1. Calibration menu

2. Display

3. Ventilation

4. Patient Data

5. Language

6. Date / Time

7. Tools

8. Info (System Information)

9. PDMS network settings

10. Service Mode

1 2 3

5 6 7 8 9

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Configuration menu in Therapy without flow sensor connector

1. Calibration O2

2. Display

3. Ventilation

4. Patient Data

5. Language

6. Date / Time

7. Tools

8. Info (System Information)

9. PDMS network settings

10. SpO2 sensor

11. Service Mode

1 2 3 4 5 6 7 8 9

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7.1 Calibration

7.1.1 Calibration Menu at Therapy (only with flow sensor connector)

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7.1.2 O2 Sensor Calibration

Or access the calibration menu directly via the button “Menu / Calibration”:

The O2 sensor is automatically calibrated when the device starts up and every 24 hours when in use. During calibration procedure, the FiO2 concentration of the fresh gas to patient is not altered. In case of a supply gas failure, oxygen sensor calibration is disabled automatically to avoid false sensor calibration

Manual calibration:

Press 21% O2 (or 21+100% O2) key. Calibration procedure starts and if successful, indicated with the green tick

Either a one point or two point calibration can be performed.

After a successful calibration, the date of the last calibration will be displayed in the corresponding field.

Automatic sensor calibration runs every time the equipment restarts and every 24h. The gas concentration to patient however is not altered during this calibration procedure.

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7.1.3 Flow Sensor Calibration

Or access the calibration menu directly via the calibration key:

Ensure no gas will flow through the flow sensor during calibration.

To do so the sensor may be held occluding either one or both ends with a sterile glove.

Press “Flow Cal” button

First Checking will appear, then Calibration running.

Following successful calibration, the date of the last calibration will be displayed in the corresponding field.

The flow sensor calibration needs to be performed each time a new sensor is put in place.

Sensor calibration remains valid, even if unit is switched off and after restart of it.

We recommend cleaning flow sensor once per day.

Flow sensor calibration is available only with InfantFlow and InfantFlow LP generator selected and in ventilation mode NCPAP and DUOPAP.

7.1.4 SpO2 Module

For more information on the SpO2 configurations please refer to the separate

available manuals.

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For the usage of SpO2 modules from Masimo, please notice: NO IMPLIED LICENSE: Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would, alone or in combination with this device, fall within the scope of one or more of the patents relating to this device. PATENT MARKING: This device is covered under one or more of patents as set forth at: http://www.masimo.com/patents.htm

7.2 Display

1. Lock touchscreen. The screen will automatically be unlocked if an alarm is triggered or the rotary knob is pressed.

2. Automatic lock activated / deactivated. Touchscreen automatically locks after a set time.

3. Display graphs as filled or regular lines.

4. Auto scale ON / OFF

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7.2.1 Touch Screen Settings

Lock touch screen

1. Push “lock” and the screen is locked directly Deactivation with pushing the rotary knob

2. Program automatic lock. Slide the bar to the right and the time will be shown. Click on time and you can chose from the list. Quit with return button and the chosen time will be shown

The touch screen also locks by holding the rotary knob for 3 seconds.

Lock is automatically cancelled in the event of an alarm or by pressing the rotary knob.

7.2.2 Trend / Graph Display

Graphs display (3)

Graphs display:

• Filled

• Not filled

filled

not filled

Auto-scaling trends:

• On

• Off

Trend patterns are automatically scaled.

Scaling is done manually with for the timeline

and with for the waves height

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7.3 Ventilation parameter settings

Ventilation parameters (page 1)

Flush time

O2 flush duration (Preoxygenation) configuration: (off/ 30 / 60 / 120 sec.)

Automatic O2 calibration

21 Vol% / 21 and 100 Vol.%. In cases where oxygen supply source does not provide 100% oxygen, this should be set to 21% only to avoid calibration at false value.

NIV Leak Compensation

Set either low, middle or high level of NIV leak compensation (≤ ~15, 30, 40%).

Unit for pressure

Selection of pressure unit (mbar / cmH2O).

NIV Tube set

Selection of the nCPAP system used. Infant Flow®, Infant Flow LP® (InspireTM), Medijet®

Maximum time for manual breath (2 – 30 sec.)

Maximum inspiration time for a manual breath

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Ventilation parameters (page 2)

Hospital settings

The button “Hospital settings” is only active if special

settings were previously saved in the fabian. Hospital settings can be loaded via the service menu or copied in service mode.

Factory settings

Reset fabian to factory settings is only possible if activated in the “Service Mode” menu

7.3.1 Standard Hospital Settings

Only reset to hospital settings if no patients is connected to the device. The “Hospital Settings” button (reset) is only active if specific settings were saved in the device.

Access hospital settings from “Service Mode” menu

This menu is also where the nurse call can be activated and deactivated.

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7.4 Patient Data

Note: Entering new patient data will delete all data from the previous patient.

1. Reset, clearing the actual patient data

2. Apply, will store patient data from now

3. Change data is used to add new patient

data. Deleting all stored data from the “old”

patient

For data input just touch the Change data and choose the field for input

For capital letters touch

Accepting data with “Apply”

7.5 Language

Selecting the user language

For available language option see below

Choose your language directly by touching and for sliding up and down touch the arrow’s

• American

• Chinese

• Czech

• Danish

• Dutch

• English

• Finnish

• French

• German

• Hungarian

• Italian

• Japanese

• Norwegian

• Polish

• Portuguese

• Russian

• Slovensko

• Spanish

• Swedish

• Turkish

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7.6 Date / Time

Changing the date and time:

Note: Changing the date or time will delete all trend data.

Once the time or data has been changed the confirmation tick will change colours.

The new information will be applied once confirmed.

7.7 Tools

Only available with an empty USB stick connected.

Save of:

Trends Trend data will be output in CSV format.

Log files Alarm and System log

Device Info SW and HW configuration with licenses

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7.8 Info

Displays the info screen (System Information) containing equipment data.

7.9 Service Mode

The Service Mode is password protected.

Service Mode provides access to hospital settings, nurse call activation/deactivation, etc.

This section is described in the Service Manual and is only for trained Service technicians.

Only allowed if patient is not connected!

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8 Alarm Limits Menu

1. Automatically sets individual alarm limits. Push button underneath.

2. Alarm volume (3 levels). Push button underneath.

3. Open log file. Push button underneath.

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Accessing the alarm limits menu by pressing the button: Alarm Limits

The alarm limits menu allows all alarm limits to manually or automatically be adjusted.

In the event of an alarm a notice will appear in the info bar and a red bell symbol indicates the alarm cause.

In addition an audible alarm will sound which may be silenced for 2 minutes by pressing the alarm mute button.

The alarm limit can be adjusted manually.

The alarm limits menu automatically focuses on the corresponding parameter.

The limit may also automatically be adjusted by pressing button underneath Autoset.

Once the alarm limit has been adjusted or there are no more active alarms, the bell symbol will turn grey.

The visual alarm message must be reset by pressing the “Alarm Mute” button.

Once the alarm limit has been adjusted or there are no more active alarms, the bell symbol will turn grey.

The visual alarm message must be reset by pressing the “Alarm Mute” button

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8.1 Automatic Alarm Limits

8.1.1 Alarm Conditions

Each displayed breath data is checked for violations of the current alarm limits.

Additionally the measured pressure will be checked against the limit every 20 milliseconds with following conditions:

Upper alarm limit of pressure:

- A breath in the range of the upper limit will reset the delay of 5 seconds.

- nCPAP: with a delay of 3000 milliseconds in case of a manual or mechanic breath ->

pressure will be checked against upper limit, if the pressure is still above the limit after 5 seconds the alarm will be signaled, otherwise it is cleared

Lower alarm limit of pressure:

- A breath in the range of the upper limit will reset the delay of 5 seconds.

- nCPAP: with a delay of 3000 milliseconds in case of a manual or mechanic breath ->

pressure will be checked against lower limit, if the pressure is still below the limit after the alarm delay set by the user in the ventilation menu, the alarm will be signaled, otherwise it is cleared

- DUOPAP: pressure will be checked against lower limit, if the pressure is still below the limit after the alarm delay set by the user in the ventilation menu, the alarm will be signaled, otherwise it is cleared

If an alarm condition has been detected, a dedicated alarm array is written, otherwise it is cleared.

8.1.2 Automatic Alarm Presets

The following alarm limits presets are used as defaults.

• CPAP [NCPAP-Mode]: Upper limit: 5 mbar above set CPAP value

• CPAP [NCPAP-Mode]: Lower limit: 2 mbar below set CPAP value

• PIP [DUOPAP-Mode]: Upper limit: 5 mbar above set P

DUO

value

• PEEP [DUOPAP-Mode]: Lower limit: 2 mbar below set PEEP pressure

• Freq: Upper limit: 150% of the measured frequency

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8.2 Alarm Log

Switch to alarm limit menu

Press the button underneath “Show Log” to access the alarm overview

The alarm list is sorted in chronological order. The parameters shown are:

• Date / Time

• Message

• Priority

(highlighted. See

12.Error – Cause – Alarms)

Press the button underneath “Hide Log” to return to the alarm limits menu.

Switching the device off will erase the alarm log. The alarmlog files from the submenu (Tools) will not be deleted.

8.3 Nurse call relay

The delay from the nurse call relay is < 1 second.

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9 Battery Operation

The device features an internal battery.

Battery run time in DUOPAP mode on full charge is approximately 3 hours

These values may vary depending on the parameter settings. The device will continuously calculate the remaining run time and display it in the info bar. The battery charge is continuously monitored.

Reduction in battery life on changing operating mode When the battery is empty, the device will automatic shutdown! Changing the operating mode can greatly shorten the operating time!

• Monitor the remaining battery life when changing the settings!

• Never leave the device and patient unattended during battery operation!

• Establish mains power supply in good time!

In the event of power failure the pneumatic system will automatically open against

atmospheric pressure so that pressure can’t build in the breathing system, allowing

spontaneous patient breathing.

When long term storing please remove the batteries.

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9.1 Power Failure

In the event of a power failure the device will automatically switch to battery power without interruption.

A visual and audible message “Power failure“ will be triggered.

This message can be confirmed with the Alarm Mute button.

The device will continuously monitor the remaining battery run time. Additional messages will be triggered at a remaining battery run time of:

• 15 minutes

• 30 minutes

• 60 minutes, only if the remaining run time is less than 60 minutes during a power failure

If the remaining run time is less than 1 minute a warning will appear prompting to immediately switch to a main power source.

After this point the battery is drained and fabian will power off.

Battery drained!

– Connect to mains –

– Charge battery for approx. 5 hours –

9.2 Operating on External Power Source

The device can also be operated from an external power source. In this case connect the external 12 - 24 Volt power source at the back of the equipment.

External power connection on the back panel.

1/2 minus 3/4 plus

NO charging when connected to 12VDC external power supply NO monitoring of remaining time on external power supply

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10 Function Fields – Ventilation Parameters

Ventilation Parameters

CPAP

• duoPAP

• CPAP

• nCPAP

• S-duoPAP

Continuous Positive Airway Pressure

Continuous flow for producing airway pressure at the CPAP level

P DUO

• duoPAP

• S-duoPAP

Upper inspiratory pressure

The lower pressure level is selected in duoPAP mode via the CPAP parameter.

P manual

• duoPAP

• nCPAP

• S-duoPAP

Manual Inspiratory pressure

Applying a manual breath

Next breath possible after a block period of 200 ms.

I-time

• duoPAP

• S-duoPAP

Inspiratory Time

Trigger

• S-duoPAP

Trigger

The trigger sensitivity can be adjusted from level 1 to 10 and can be turned off.

• All modes

Oxygen concentration

Inspiratory oxygen concentration setting

O2 Flush

• All modes

Oxygen flush

Perform O2 flush / oxygen spray (Preoxygenation for max. 2 minutes)

Max. time manual breath

• All modes

Maximum time manual breath*

Maximum duration allowed for manual breaths. Adjustable from 2 – 30s.

*In Ventilation menu

Flush Time

• All modes

Duration of O2 Flush*

Adjustable from 0 – 120s.

*In Ventilation menu

Flow

• O2 Therapy

Flow setting

Adjustable from 0 – 19 l/min

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11 Ventilation Modes

The ventilator is intended for the following ventilation modes:

• NCPAP NIV mask ventilation

• duoPAP NIV mask ventilation

• O2 Therapy High and Low Flow Oxygen Therapy HFNC

11.1 nCPAP / duoPAP

In nCPAP / duoPAP mode the patient spontaneously breathes via mask or nasal prongs.

A NIV Trigger option can be additionally implemented in order to provide those modes with Breath detection (Apnea monitoring with alarms) and triggered supported breaths (or synchronized transition from low to high CPAP levels) in duoPAP. Depending on the generator in use, fabian will then automatically select the proper NIV trigger sensor:

• Flow sensor (neonatal) with Infant Flow/INSPIRE and Infant FlowLP generators

• Pressure sensor with Medijet (by Medin) generator

Additionally monitoring SpO2 and PCO2 is always recommended.

nCPAP: Supplies a positive airway pressure with automatic leak compensation. The maximum flow compensation is selectable by menu .

duoPAP: Same as nCPAP but with the option of positive pressure ventilation with adjustable frequency and inspiratory period.

This mode requires a special nCPAP patient set with nCPAP generator. Before using the nCPAP / duoPAP mode the correct system must be specified in the specifications menu. The following systems are currently can be used:

• Infant Flow ®

• Infant Flow LP ®

• MediJet ®

• Inspire 

Function fields and ventilation parameters Ventilation additives

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If Insp. time is set lower than 1 sec. time maximum pressure may not be reached. Depending on the tube set, nCPAP generator and humidifier

11.2 O

Therapy mode (High and Low flow oxygen therapy)

HFNC

O2 Therapy allows use of a continuous flow of blended gas, from 1 – 30 LPM. Nasal cannulas of various makes like F&P, Atom or similar can be used. There are no alarm functions active in this

mode, except for the set FiO2

Note:

This mode can also be used to put the ventilator in standby mode. By setting a flow of 4 LPM, the humidifier dual servo temperature controls remain active, so no need to switch it off in case of short term standby mode.

There are no patient alarms active in this mode.

11.3 Special Functions

11.3.1 Manual inspiration (man. Breath)

In virtually all ventilation modes a manual breath (with the ventilation parameters set in the current ventilation mode) can be triggered by pressing the “manual inspiration” button

The duration of the manual breath can be set under Configurations Menu > Ventilation. This may last 2-30 seconds, then a termination of the manual breath will be forced. The next manual breath is only allowed after a blocking period of 200 ms.

11.3.2 O2 Flush / Preoxygenation

Press the “O

Flush” button to trigger an O2 flush.

Short-term oxygen spray (O2-Flush) with an increased O2 concentration is permissible in all ventilation modes. This will automatically be ended after a maximum of 2 minutes. (also see defaults in menu: Configuration -> Ventilation -> Flush time)

Press the “O2 Flush” button in a ventilation mode to initiate the O2-Flush. The flush concentration may now be set with the rotary pulse knob. Pressing the O2 button again will end the flush prematurely.

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11.3.3 Standby – stopping / pausing mechanical ventilation

The “Start / Stop” button may be used to interrupt mechanical ventilation for 2

minutes.

Hold down the key for about three seconds. Observe messages on the screen (information bar)

In nCPAP and duoPAP mode ventilation may be interrupted indefinitely.

In both cases the built-in gas mixer delivers a minimal flow to prevent heat buildup inside the ventilatory gas moistener.

Risk of oxygen undersupply!

The standby function is not intended for siphoning. A disconnection or reconnection is not recognised.

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12 Error – Cause – Solution – Alarms

Alarms are categorised into 3 priority levels; high, medium and low. They differ visually and acoustically depending to the priority.

I=HIGH blinking message highlighted red Tone: ♪♪♪-♪♪-♪♪♪-♪♪ 4 sec. pause II=MEDIUM blinking message highlighted yellow Tone: ♪♪♪ 5 sec. pause III=LOW message highlighted yellow Tone: ♪ 15 sec. pause

This table is intended to help you determine and resolve the cause of an alarm message.

If you are looking for alarms regarding SpO2 or PRICO please refer to their separate supplements.

Alarm text

Alarm Type

Cause

Solution

Main priority

Sub Priority

Coolingfan defect

System failure

Fan not moving

Contact your local ACUTRONIC Distributor

I 1 COM interface

System failure

System error

Contact your local ACUTRONIC Distributor

I 1 DIO interface

System failure

System error

Contact your local ACUTRONIC Distributor

I 1 I2C interface

System failure

System error

Contact your local ACUTRONIC Distributor

I 1 parallel interface

System failure

System error

Contact your local ACUTRONIC Distributor

I 1 SPI interface

System failure

System error

Contact your local ACUTRONIC Distributor

Charge battery (<15min)

Electrical power

Remaining battery time < 15 min.

Switch to mains supply. The device continues in battery mode without interruption. Alarm may be silenced with Mute Alarm.

checksum conductor PIC

System failure

System error

Contact your local ACUTRONIC Distributor

checksum monitor PIC

System failure

System error

Contact your local ACUTRONIC Distributor

Low physical memory - please reboot!

System failure

System error

Contact your local ACUTRONIC Distributor

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Alarm text

Alarm Type

Cause

Solution

Main priority

Sub Priority

Air supply pressure

System alarms

Air supply pressure too low.

Ensure pressure above 2 bar.

Oxygen supply pressure

System alarms

Oxygen supply pressure too low.

Ensure pressure above 2 bar.

Safety relay defect

System failure

Safety relay defective.

Contact your local ACUTRONIC Distributor

Tube Occlusion

System alarms

Inspiration tube blocked/kinked Excessive deviation between inspiration and expiration pressure sensor.

Check ventilation tubes. Check pressure sensor connection (proximal). Contact your local ACUTRONIC Distributor

Voltage monitoring

System failure

System error

Contact your local ACUTRONIC Distributor

Battery defect

Electrical power

No power or too less power from battery.

Change battery, check fuse.

check Blender

System alarms

Proportional mixer or control defective

Contact your local ACUTRONIC Distributor

I 2 Flat battery!

Electrical power

Remaining battery time < 1 min.

Immediately switch to mains supply

Patient disconnected

Disconnection/Tu bus blocked

Leak or disconnection.

Check tubing system for leaks. Check setting of Pinsp.

Clean flow sensor

Sensor alarms

Water or secretion in flow sensor

Clean/replace flow sensor.

Flow sensor defect

Sensor alarms

Damaged heating wires inside flow sensor.

Replace flow sensor.

Flow sensor not connected

Sensor alarms

Flow sensor not connected. Defective sensor cable.

Check flow sensor and sensor cable connection.

O2 sensor calibration failed

Sensor alarms

Error occurred during calibration.

Repeat calibration.

Oxygen sensor defect

Sensor alarms

O2 sensor defective.

Replace O2 sensor.

Oxygen sensor used up

Sensor alarms

O2 sensor worn.

Replace O2 sensor as quickly as possible. Calibration still available.

O2 value out of range

Sensor alarms

O2 sensor or mixer defective.

Replace O2 sensor or Contact your local ACUTRONIC Distributor.

4 Apnea alarm

Patient alarms

Spontaneous patient breathing

Switch to controlled

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Alarm text

Alarm Type

Cause

Solution

Main priority

Sub Priority

halted.

ventilation.

High PIP / High pressure

Patient alarms

Pressure rise in tubing system, mechanical inspiration was reduced to relieve the system.

Check tubing system. Replace patient system.

7 High PEEP

Patient alarms

PEEP 6 mbar above set value for at least 15 seconds.

Check tubing. Check patient connection.

Low PIP

Patient alarms

Leak or disconnection.

Check tubing system for leaks. Check setting of Pinsp. Check patient connection.

Charge battery (<30min)

Electrical power

Remaining battery time < 30 min.

Switch to mains supply. Alarm may be silenced with Mute Alarm. The device continues in battery mode without interruption.

Charge battery (<60min)

Electrical power

Power failure. Internal battery remaining charge less than 60 minutes.

Switch to mains supply. Alarm may be silenced with Mute Alarm. The device continues in battery mode without interruption.

High breath rate

Patient alarms

Hyperventilation self-trigger

Adjust frequency Increase trigger threshold

Low PEEP

Patient alarms

Leak or disconnection.

Check tubing system for tight connection. Increase flow.

Inspiratory pressure not reached

System limits

Leak. Flow too low.

Check tubing system for tight connection. Increase flow.

III

Power failure

Electrical power

Power failure

Switch to mains supply. Alarm may be silenced with Mute Alarm. The device continues in battery mode without interruption.

III

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12.1 Application error

In case the device software encounters an unexpected error a window will pop up in the middle of

the screen with the following text in English: “Application Fabian.exe encountered a serious error and must shut down.”

In case there is an audible alarm follow these steps:

1. Immediately start ventilation of patient with an alternative treatment

2. Shut down the device by holding the on/off button till it turns off

3. Report the incident to your local distributor

4. Use the device only if it is inevitable

As long as there is no accompanying audible alarm follow these steps:

1. Stop interacting with the device

2. Prepare an alternative treatment for the patient while the device is kept under supervision

3. Start ventilation of patient with an alternative treatment

4. Shut down the device by holding the on/off button till it turns off

5. Report the incident to your local distributor

6. Use the device only if it is inevitable

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13 Replacing the Oxygen Sensor

Switch off the device and unplug from power supply.

Loosen the screws to open the O2-sensor flap. Remove the cable from the O2-sensor.

Unscrew the O2-sensor.

Replace it with a new O2 sensor.

Connect the O2-sensor with the plug

Connect the O2-sensor flap and retighten the screws

Switch on fabian. Calibrate the oxygen sensor at 21 vol. % and 100 vol. %.

Used O2 sensors must be properly disposed of. Please note:

Do not open the O2 sensor – risk of chemical burns!

Dispose of O2 sensors in accordance with local waste management regulations (cf. battery disposal). Please contact local environmental or regulatory agencies and appropriate waste management companies for information.

When installing a brand new sensor a second calibration can be necessary after about 30 minutes. If possible, expose the new sensor for about 30 minutes to the ambient air BEFORE installing

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14 Service and Maintenance Intervals

Always clean and disinfect equipment or equipment components prior to any maintenance – including when returning the equipment for repair.

Every 6 months

Perform the following work:

• Clean cooling air filters, replace if necessary

Every 12 months

Maintenance and safety inspections

Perform the following work:

• Device check as specified by manufacturer

• Check alarm and limit value functions

• Check pressure connections

• Check electrical connections

• Check safety shutdown calibration

Replace the following components:

• Air and oxygen Input filter

• Cooling air filters

• O2 sensor

• Flow Sensor

Every 4 years

Replace the following components:

• Air and oxygen Input filter

• Cooling air filters

• O2 sensor

• Linear valves pressurised air / oxygen mixer

• Input pressure regulator pressurised air / oxygen

• Calibration valves

• Lithium battery

• Flow Sensor

Maintenance and safety inspections must be performed by ACUTRONIC trained experts with access to suitable testing and measuring equipment.

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15 Sterilisation / Cleaning / Disinfection

The device must be prepared after each patient treatment.

Cleaning and disinfection procedures according to country specific regulations

The device may not be sterilized under any circumstances! Flow Sensor

• Do not clean sensor with compressed air or water jet, as the sensor wires could be destroyed.

• Never treat sensor in automatic cleaning-/disinfection machine.

• Rinse flow sensor element in distilled water.

• Thoroughly shake off residual water.

Steam sterilization at 134°C for 2 minutes (half cycle). The flow sensor should be changed when it is unable to be calibrated. Replace and clean sensor once a day. It has been shown that this increases the service life of the sensor. Never connect an uncalibrated sensor to a patient. Always calibrate the sensor before connecting to a patient.

Ventilation tubes

Preparation according to manufacturer information

Heating wire

Preparation according to manufacturer information

Temperature probe

Preparation according to manufacturer information

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16 Setting Ranges and Parameters

Mode

Parameters

NCPAP

DUOPAP

O2 Therapy

min

max

min

max

min

max

I-time [sec]

0.15

E-time [sec]

0.2

Frequency [1/min]

O2 [%]

100

O2 flush [%]

100

Flush Time [s]

120

Man Breath Time [s]

30 2 30

Flowmin [l/min]

CPAP [mbar]

13 2 13

Pmanual [mbar]

PDUO [mbar]

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17 Standard Accessories

Item no.

Description

498101

Oxygen sensor

153001.01

Infant Flow connection tube

111225

Proximal pressure connection sleeve

499392.00US

Adapter NIST – DISS O2

499391.00US

Adapter NIST DISS Air

151100.01

Flow sensor connector cable

151111

Flow sensor, single use

151120

Flow sensor, reusable

You can obtain a complete accessories catalogue from your distributor or direct from ACUTRONIC Medical System AG.

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18 Technical Specifications

18.1 Ambient Conditions

During operation

Temperature Air pressure Relative humidity

10 - 40°C (50 – 104 °F) 700 - 1060 hPa 10 – 90 %, non-condensing

During storage and transportation

Temperature Air pressure Relative humidity

-20 - 60°C (-4 – 140 °F) 500 - 1060 hPa 10 – 95 %, non-condensing

The minimum and maximum ambient temperatures in the clinical area will not affect the accuracy of the flow, pressure or oxygen measurement.

18.2 Monitoring

Acoustic pressure of alarm tones Alarm tone sequence IEC 60601-1-8 Lowest possible setting: 52 db(A) Highest possible setting: 68 db(A)

A weighted sound pressure level in 1m distance: 40dB

Airway pressure

Alarm lower threshold value: If lower alarm limit undershot Alarm upper threshold value: If upper alarm limit exceeded

Inspiratory O2 concentration

Alarm: Set value ± 5 Vol% for > 1 minute at 21 Vol% below threshold value 18 Vol%

Breath frequency

Alarm: If alarm limit exceeded

Apnoea alarm

Alarm: If no breathing activity is recognized

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18.3 Measuring

Airway measurement Range: -10 – 110 mbar Precision: ± 4% Resolution: 0.1 – 1 mbar

Inspiratory Oxygen Concentration: Max. error delivered vs. set FiO2: 3% FiO2

Tube leak range: 10 – 50%

18.4 Settings in Ventilation Menu

Flush time (O2)

• OFF

• 30 seconds

• 60 seconds

• 120 seconds

Automatic O2 calibration

• 21% Vol.

• 21% Vol. and 100% Vol.

NIV Leak compensation

• Low (up to 15%)

• Middle (up to 30%)

• High (up to 40%)

Unit for pressure

• mbar

• cmH2O

NIV Tube set

• MediJet ®

• Infant Flow ®

• Infantflow LP ®

Max time manual breath

• 2 – 30 seconds

18.5 Dimensions / Weight

W x H x D

24 cm x 27 cm x 35 cm

Weight

Approx. 9 kg

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18.6 Ratings

Pressurised air supply

2.0-6.5 bar / max. 40 l/ min. Connection thread: NIST Note: Medical grade air (dust-free, oil-free and dry).

Oxygen supply

2.0-6.5 bar / max. 40 l/min. Connection thread: NIST

Power supply

100-240 VAC

0.4 – 0.8 A 50/60Hz external 12 - 24 VDC 3 AT (Charging only when more than 12.5V)

Power rating

duoPAP mode: max. 70 W Standby, fabian connected to mains: 35 W (battery charging)

Internal Battery

13.2 V / 4500 mAh max. charging time: 5 hours Fuse 3 AT battery charge is continuously monitored Battery life 3 hour

Sound pressure

Max. 68 dB (A)

Device fuse

T 630 m A L (from SN: xxxxxx-0159 T 1 A L)

Safety class

Type B ≙ EN 60601-1

Certifications of IEC

60601-1, 60601-1-2, 60601-1-8, 60601-2-12

Classification to EC directive 93/42/EEC

Class II b

IP Protection

IPX1, Protected against falling water Equivalent to 1-

1.5mm rainfall per minute for duration of 10 minutes. Unit is placed in its normal operating position.

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18.7 Data storage

Trend

maximum 5 days storage every 30 seconds

Alarms

maximum 1000 messages

Log

Maximum 10 Log Files. Log is stored during power failure When Log capacity is reached index is shifted and oldest log file deleted

18.8 Applied Parts

Applied part for the device is the Tube set.

18.9 Device Checks

The following internal device checks are performed on start up:

• COM: Communication between GUI and Conductor PIC.

• I2C: Communication between GUI to Acu PIC, FRAM and Multiplexer.

• PIF: Communication between GUI and Parallel Interface

• DIO: Communication between GUI and Digital I/O.

• SPI: Communication between GUI and Monitor PIC.

• Voltage: Voltage Error Check via SPI

• Relais: Relais Check via SPI

• SPICks: SPI Checksum

In addition an audible alarm can be heard on start-up. The user must check if this alarm can be heard to verify that the speaker is functioning.

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18.10 Gas blender function

The air/oxygen blender provides a gas blend with adjustable proportions of oxygen and air. Gas from the central gas supply enters the device via the gas input connections. Blending of the gases occurs via two proportional valves. The proportional valves, which also act as return valves, prevent the return flow of a gas into the supply cable of the other gas.

An oxygen sensor measures the inspiratory oxygen concentration.

1. Oxygen 2.0 – 6.5 bar

2. Air 2.0 – 6.5 bar

3. Filter

4. Pressure Regulator

5. P sensor

6. Proportional valve

7. To Manifold

The minimum base flow is 4 l/min in all modes except in O2 Therapy.

For more information, please refer to the “Service Manual for fabian evolution”

1 2 3

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18.11 Acoustic Energy

201.9.6.2.1.101

TABLE: Acoustic energy

VBS used :

fabian Therapy evolution

—

Accessories :

Patient set

—

Humidifier (water level) :

N/A — Test lung :

Part No. 1116

—

Ventilator settings :

Acc. to TAB, 201.105 mid column

—

Measurement No.

Location

Sound pressure level

Remarks

Background

Lp A (dB)

33.91) / 50

Leq (dB) / max.@ (Hz)

32.82) / 50

Leq (dB) / max.@ (Hz)

36.3 / 12500

Leq (dB) / max.@ (Hz)

33.1 / 12500

Leq (dB) / max.@ (Hz)

33.3 / 12500

Leq (dB) / max.@ (Hz)

37.6/ 12500

Leq (dB) / max.@ (Hz)

Calculated average

51.0 / 47.1

Lin / A weighted (dB)

Supplementary information: LpA: A weighted sound pressure level in 1m distance : 40dB

Highest Level at Pos 2

Highest Level at Pos 4 etc.

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19 Electromagnetic Compatibility Statement

Note: fabian Therapy evolution is a MEDICAL APPLIANCE subject to specific precautionary measures with regard to EMC and must be installed and started up according to the notices according to the instructions in this manual.

Warning: Portable and medical HF communication devices could impact MEDICAL

APPLIANCES!

Warning: Never use fabian Therapy evolution directly adjacent to, or stack with other

apparatuses. If unavoidable, be sure to monitor the equipment for proper operation with this set-up.

Warning: Using other accessories, cables or converters with fabian Therapy evolution may result

in increased electromagnetic interference and reduce the immunity of fabian Therapy evolution.

Note: The key performance characteristics of the fabian Therapy evolution ventilator are:

• fabian Therapy evolution must operate within the defined specifications and the medical purpose. Failure to meet these specifications will result in respiration being stopped.

• For this reason a second, stand-alone ventilation unit must always be available, e.g. resuscitation bag.

Guideline and manufacturer declaration – electromagnetic emission

The device "fabian Therapy evolution" is intended for operation in the environment described below. The customer or user of the "fabian Therapy evolution" apparatus should ensure it is operated in this type of environment.

EMI measurement

Compliance

Electromagnetic environment – guideline

HF emission CISPR 11

Group 1

The device "fabian Therapy evolution" uses HF energy solely for internal operation. Its HF emission is thus very low and interference with adjacent apparatuses is unlikely.

HF emission CISPR 11

Class A

The device fabian Therapy evolution is suitable for use in all other areas except residential areas and areas directly connected to a public mains supply which also supplies buildings used for residential purposes.

Emission of harmonics IEC 61000-3-2

Not applicable

Emission of voltage fluctuations / flickers IEC 61000-3-3

Not applicable

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Guideline and manufacturer declaration – electromagnetic immunity

The device fabian Therapy evolution is intended for operation in the environment described below. The customer or user of the fabian Therapy evolution apparatus should ensure it is operated in this type of environment.

Immunity testing

IEC 60601 test level

Compliance level

Electromagnetic environment – guideline

Electrostatic discharge (ESD)

IEC 61000-4-2

± 6 kV contact ± 8 kV air

Floors should be wooden or concrete or tiled with ceramic tiles. For flooring made from synthetic materials the relative air humidity must not be less than 30%.

Quick electric transients/burst

IEC 610004-4

± 2kV for power cords

± 1kV for in/output cables

± 2kV for power cords

± 1kV for in-/output cables

The mains quality should correspond to typical business or hospital environments.

Surges

IEC 61000-4-5

± 1 kV lead to lead

± 2 kV lead to ground

± 1 kV lead to lead

± 2 kV lead to ground

The mains quality should correspond to typical business or hospital environments.

Voltage drops, temporary power failures and fluctuations IEC 61000-4-11

<5% UT (>95% drop of

UT) for ½ period

40% UT (60% drop of UT) for 5 periods

70% UT (30% drop of UT) for 25 periods

<5% UT (>95% drop of UT) for 5 seconds

<5% UT (>95% drop of UT) for ½ period

40% UT (60% drop of UT) for 5 periods

70% UT (30% drop of UT) for 25 periods

<5% UT (>95% drop of UT) for 5 seconds

The mains quality should correspond to typical business or hospital environments. If the operator of the fabian Therapy evolution requires continued use in the event of a power failure we recommend connecting the fabian Therapy evolution to an uninterruptible mains supply or a battery.

Magnetic field at supply frequency (50/60 Hz) IEC 61000-4-8

3 A/m

Magnetic fields at the mains frequency should correspond to typical values in business and hospital environments.

Remark UT is the mains alternating voltage prior to applying the test level.

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Guideline and manufacturer declaration – electromagnetic immunity

Immunity testing

IEC 60601 test level

Compliance level

Electromagnetic environment – guideline

Never use portable or mobile radio devices closer to the fabian Therapy evolution, including cables, than the recommended safety distance calculated using the equation applicable to the transmission frequency.

Recommended safety distance

HF interference currents IEC 61000-4-6

3 Veff 150 kHz to 80 MHz beyond ISM bands a 10 Veff 150 kHz to 80 MHz within ISM bands b

10 V

d = 0.35√P

d = 1.2√P HF interference radiation IEC 61000-4-3

10 V/m 80 MHz to 2.5 GHz

10 V/m

d = 1.2√P 80 MHz to 800 MHz d = 2.3√P 800 MHz to 2.5 GHz

P being the transmitter’s nominal rating in Watts (W) per manufacturer specifications and being the recommended safety distance in metres (m).

The field strength of stationary radio transmitters should be below the compliance level d on all frequencies as tested on site c.

Interference may occur in proximity of apparatuses bearing the following symbol:

REMARK 1 At 80 MHz and 800 MHz the higher frequency range applies.

REMARK 2 These guidelines may not apply to all case. The propagation of electromagnetic quantities is influenced by absorption and reflexion of buildings, objects and people.

The ISM bands (industrial, scientific and medical) between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz;

13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.7 MHz.

The compliance levels in ISM frequency bands between 150 kHz and 80 MHz and between 80 MHz and 2.5 GHz are defined as such so as to decrease the probability of mobile/portable transmitters causing interference in the event they are accidentally brought in to the vicinity of the patient. For this reason an additional factor of 10/3 is used when calculating the recommended safety distance of transmitters in this frequency range.

In theory the field intensity of stationary transmitters, as e.g. base units of radio telephones (mobile/cordless) and mobile land radio devices, amateur radio stations, AM and FM radio stations and television stations cannot be predefined precisely. A study of the location should be conducted to determine the electromagnetic environment with regard to stationary transmitters. If the field intensity at the location where the fabian Therapy evolution is used exceeds the above compliance levels, fabian Therapy evolution should be monitored for proper function. If unusual performance characteristics are observed, additional measures may be required, as e.g. changing the direction or location of the fabian Therapy evolution.

Above a frequency range of 150kHz to 80MHz the field intensity should be below 10 V/m.

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Recommended safety distances between portable and mobile HF communication devices and the device " fabian Therapy evolution "

fabian Therapy evolution is intended to be operated in an electromagnetic environment with controlled HF interferences. The operator of the fabian Therapy evolution can help avoid electromagnetic interference by maintaining the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the device fabian Therapy evolution – depending on the output rating of the communication device, as listed below.

Maximum transmitter power output W

Safety distance depending on transmission frequency m

150 kHz to 80 MHz outside ISM bands

150 kHz to 80 MHz within ISM bands

80 MHz to 800 MHz

800 MHz to

2.5 GHz

d = 0.35√P

d = 1.2√P

d = 2.3√P

0.01

0.04

0.12

0.23

0.1

0.13

0.38

0.73

0.40

1.2

2.3

1.3

3.8

7.3

100

4.0

For transmitters with a maximum power output not listed in the above table the recommended safety distance d in metres (m) can be determined using the equation from the corresponding column, with P being the transmitter’s maximum power output Watts (W) per the transmitter’s manufacturer specifications.

REMARK 1 At 80 MHz and 800 MHz the safety distance of the higher frequency applies.

REMARK 2 The ISM bands (industrial, scientific and medical) between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.7 MHz.

REMARK 3 An additional factor of 10/3 is used when calculating the recommended safety distance for transmitters within the ISM frequency between 150KHz and 80 MHz and between 80MHz and 2.5GHz to reduce the probability of mobile/portable transmitters causing interference if accidentally brought into the vicinity of the patient.

REMARK 4 These guidelines may not apply to all case. The propagation of electromagnetic quantities is influenced by absorption and reflexion of buildings, objects and people.

ACUTRONIC Ventilation Beyond Limits Instruction

Specifications and Main Features

Frequently Asked Questions

User Manual