Manual Fabian Ncpap Evolution 1.07 GB

Operating Manual
fabian + nCPAP
evolution
Ventilator for Premature Babies and Children
OM Version: 1.07 GB
SW Version: 1.0.0.n
Warning
Before making use of the ventilator users must

familiarize themselves with the device’s function
by careful reading of the operating manual.
Manufacturer:
ACUTRONIC Medical Systems AG

Fabrik im Schiffli
CH-8816 Hirzel / Switzerland
Operating Manual fabian + nCPAP evolution 2 / 95

1 Working with the manual
Explanation of page structure
The header on each page is for quick orientation

 Main chapter
 Sub-chapter
Left side of the page

… Explanations, instructions and detailed description on the topic or procedure.
Right side of the page...

… shows the graphic representations, operating elements and displays belonging to the description
and guides the user through any handling steps.
3 / 95 Operating manual fabian + nCPAP evolution

Table of contents
1 Working with the manual ................................................................................................................... 3
2 Operating Manual................................................................................................................................ 8
2.1 Notes and Warnings................................................................................................................... 9
3 General Notes .................................................................................................................................... 10

3.1 Essential information ................................................................................................................ 10
3.2 Maintenance .............................................................................................................................. 12
3.3 Liability for Function / Damage ............................................................................................... 12
3.4 Purpose ....................................................................................................................................... 13
3.5 Scope of Delivery ...................................................................................................................... 13
3.6 Contra-indications .................................................................................................................... 14
4 System Overview ............................................................................................................................... 15

4.1 Front Connections ..................................................................................................................... 16
4.2 Back............................................................................................................................................. 17
4.3 Symbols....................................................................................................................................... 18
5 Operation and Display ...................................................................................................................... 20

5.1 Operating structure concept .................................................................................................. 20
5.1.1 Operating options.................................................................................................................. 20
5.1.2 Buttons .................................................................................................................................... 21
5.1.3 Incremental encoder ............................................................................................................ 21
5.2 Display concept structure ....................................................................................................... 22
5.2.1 Display areas ......................................................................................................................... 22
5.2.2 Screen ..................................................................................................................................... 22
5.2.3 Information bar ...................................................................................................................... 23
5.2.4 Numeric field / alarm limits ................................................................................................. 24
5.2.5 Graphic field........................................................................................................................... 25
5.2.6 LED display ............................................................................................................................. 26
5.3 Ventilation menu ....................................................................................................................... 27
5.3.1 Operation – general .............................................................................................................. 27
5.3.2 Operation – pre-setting ........................................................................................................ 28
5.3.3 Dependency between ventilation parameters ................................................................ 29
5.3.4 Locking of ventilation parameters ..................................................................................... 30
5.4 Graphic menu ............................................................................................................................ 31
5.4.1 Curves ..................................................................................................................................... 32
5.4.2 Loops ....................................................................................................................................... 33
5.4.3 Trend menu ............................................................................................................................ 35
6 Preparation for operation ................................................................................................................ 36

6.1 Establish power supply ............................................................................................................ 36
6.2 Establish gas supply ................................................................................................................. 36
6.3 Connect tube system ................................................................................................................ 37
6.4 Breathing gas humidifier ......................................................................................................... 38
6.5 Connect nCPAP tube system .................................................................................................. 39
6.6 Switching on device ................................................................................................................. 40
6.7 Switching on device ................................................................................................................. 41
7 Device check fabian evolution........................................................................................................ 42
8 Configuration menu ........................................................................................................................... 43

8.1 Calibration .................................................................................................................................. 44
8.1.1 O2 sensor calibration ............................................................................................................ 44
8.1.2 Flow sensor calibration ....................................................................................................... 45
8.2 Display......................................................................................................................................... 46
8.3 Ventilation parameters - settings........................................................................................... 47
8.4 Patient data ................................................................................................................................ 49
8.5 Language .................................................................................................................................... 49
8.6 Date / time .................................................................................................................................. 49
8.7 Tools ............................................................................................................................................ 50
8.8 Info ............................................................................................................................................... 50
8.9 Service mode ............................................................................................................................. 50
9 Alarm Limits - Menu .......................................................................................................................... 51

9.1 Automatic alarm limits ............................................................................................................. 53
9.2 Alarm log..................................................................................................................................... 53
10 Function Fields - Ventilation Parameters ...................................................................................... 54

11 Battery Operation .............................................................................................................................. 55
11.1 Failure of the power supply ..................................................................................................... 56
11.2 Operation with external power supply .................................................................................. 57
12 Ventilation Modes ............................................................................................................................. 58

12.1 IPPV ventilation ......................................................................................................................... 59
12.2 S IPPV ventilation ...................................................................................................................... 60
12.3 S IMV ventilation ....................................................................................................................... 61
12.4 S IMV + PSV ventilation .......................................................................................................... 62
12.5 PSV ventilation .......................................................................................................................... 63
12.6 CPAP............................................................................................................................................ 64
12.7 nCPAP / duoPAP ....................................................................................................................... 65
12.8 O2 therapy .................................................................................................................................. 66
12.9 Ventilation supplements .......................................................................................................... 67
12.9.1 Volume limit ....................................................................................................................... 67
12.9.2 Volume guarantee ............................................................................................................ 68
12.10 Special functions ...................................................................................................................... 69
12.10.1 Starting inspiration manually .......................................................................................... 69
12.10.2 Nebulizing medicines ....................................................................................................... 70
12.10.3 O2 flush / pre-oxygenation ............................................................................................... 71
12.10.4 Standby – stopping mechanical ventilation ................................................................. 72
13 Error – Cause – Remedy - Alarms .................................................................................................. 73
14 Changing Oxygen Sensor ................................................................................................................. 76
15 Maintenance Intervals ..................................................................................................................... 77
16 Preparation / Cleaning / Disinfecting ............................................................................................. 78
17 Technical Data ................................................................................................................................... 80

17.1 Ambient conditions ................................................................................................................... 80
17.2 Setting ranges and parameters .............................................................................................. 81
17.3 Precision of measured value display .................................................................................... 83
17.4 Monitoring .................................................................................................................................. 84
17.5 Resistance values ..................................................................................................................... 85

17.6 Pre-set parameters................................................................................................................... 85
17.7 Dimensions / weight ................................................................................................................. 86
17.8 Operating values ....................................................................................................................... 86
17.9 Device outputs ........................................................................................................................... 87
17.10 Data storage .............................................................................................................................. 87
17.11 Gas blender function ................................................................................................................ 88
18 Accessories........................................................................................................................................ 89
19 Annex ................................................................................................................................................... 90
19.1 Explanation of electromagnetic compatibility ..................................................................... 91

2 Operating Manual
This operating manual describes the device components and their operation. They are structured to
enable you to become familiar with the operation of your ventilator step by step.
Read the operating manual through carefully before you begin to work with the
ventilator.
Once you are familiar with the basic design and operation of the ventilator, you can use the operating
manual as a reference guide.
The table of contents will help you to find a topic quickly.
The operating manual are intended solely for customer information and are only refreshed or replaced
in response to customer requests.

2.1 Notes and Warnings
NOTE
Notes supplement the action instructions
DANGER
DANGER indicates a non-imminent, but latent danger, which if not avoided can
lead to death or physical danger.
DANGER
PLEASE NOTE
PLEASE NOTE indicates a danger, which if not avoided can result in damage to
the device.

3 General Notes
3.1 Essential information
All handling of the ventilator presumes precise knowledge and compliance with this
operating manual. The device is only intended for the described use.
The ventilator may only operate with accessories recommended by Acutronic Medical
Systems AG.
The ventilator may only be operated by qualified expert staff or under their supervision
so that a remedy may be found immediately in case of a malfunction.
An alternative ventilation system (e.g. air-mask bag unit) must always be available
during use of the ventilator.
If the ventilator has a recognizable defect, as a result of which the life-preserving

functionality is no longer guaranteed, ventilation of the patient must be undertaken
immediately with an independent ventilatory device (e.g. air-mask bag unit).
The ventilator may not be used in combination with inflammable gases or narcotic
agents – there is otherwise an acute risk of fire and explosion!
The ventilator may not be used areas under risk of explosion!
An acoustic alarm indicates a system or patient alarm and requires action by medical
specialists in all cases.
If a defect is identified during a device check, the ventilator may not be connected to a
patient under any circumstances!
Electric coupling with devices not mentioned in this operating manual may only be
possible after consultation with the manufacturers or an expert.

The ventilator may not be covered or set up in a way that negatively affects the mode of
operation.
Disconnect the mains plug before opening the housing!
No antistatic or electrical conductive tubes may be used.
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.

3.2 Maintenance
The device is a ventilator assigned to device We recommend ACUTRONIC Medical Systems

class IIb under European directives. AG exclusive representatives for the
conclusion of a service agreement and for
 A check must be conducted every 12
repairs.
months, which must occur on account
of the manufacturer’s regulations. Only use original ACUTRONIC parts for
 Maintenance may only be carried out maintenance.
by specialists trained by Acutronic,
Comply with the chapter “Maintenance
who possess the appropriate
intervals.”
measuring equipment and testing
facilities.
3.3 Liability for Function / Damage
In all cases, liability for the function of the to observe the above remarks. Guarantee and
device passes to the owner or operator if the liability conditions of the terms of sale and
device is improperly maintained or repaired by delivery of ACUTRONIC Medical Systems AG
individuals who do not belong to ACUTRONIC are not extended by the above remarks.
Medical Systems AG Service or if handling that
does not correspond with the intended use
occurs. ACUTRONIC Medical Systems AG
ACUTRONIC Medical Systems AG does not

assume liability for damage caused by failure

3.4 Purpose
Ventilator for premature babies, the newly-born  continuous positive airway pressure
and children up to 30 kg bodyweight. (CPAP)
 pressure support ventilation (PSV)
The fabian evolution is intended for in-patient
 pressure support ventilation combined
use in hospitals, medically-used rooms and with SIMV (SIMV + PSV)
intra-hospital patient transport.
 NIV ventilation
The ventilator is intended for the following nCPAP / duoPAP
ventilation types:  Oxygen therapy
 intermittent positive-pressure The device is operated by a doctor or under his

ventilation (IPPV) instructions by a qualified person with a
 synchronized intermittent mandatory specialist training; every user must be briefed
ventilation (SIMV) on the device and be familiar with the device’s
 synchronized intermittent positive operating manual and operation.
pressure ventilation (SIPPV)
3.5 Scope of Delivery

The scope of delivery includes the following articles:
1 x 7250 ventilator fabian + nCPAP evolution
1 x 1031 flow sensor
1 x 1016 flow sensor cable
1 x 7006 membrane exspiration valve
1 x 7007 membrane holder
1 x 1116 test lung
2 x 7057 infant flow supply tube
1 x 1126 power cable
1 x operating manual

3.6 Contra-indications
No contra-indications for the use of a neonatal pediatric 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
CH-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

4 System Overview

4.1 Front Connections
4-1
1 Inspiration tube.
2 Connection for nCPAP system
3 Pressure measurement tube / prox.
4 Expiration tube

4.2 Back
4-2
1 Mains connection with fuse holder

2 Terminal studs for potential equalization
3 Connection for external voltage supply 12 – 24V DC
With HW Rev. 1.0 use only with connection cable Part. No. 7272
4 Nurse call ( opener or closer)
5 Connection for flow sensor
6 Network connection for data management
7 USB connection for data output (log file) and system update.
8 RS232 interface. CO2 sensor, service, PDMS
9 Connection for compressed air supply
2.0 – 6.5 bar / 40 l/min
10 Connection for medicine nebulizer (option)
11 Oxygen sensor
12 Connection for extracorporeal trigger (option)
13 Connection for O2 supply
2.0 – 6.5 bar / 40 l/min

4.3 Symbols
Symbol Description
RS232, serial interface
USB connection
Network connection RJ45
Connection for medicine nebulizer
Connection for external trigger
Nurse call
Caution, take note of important safety information and

precautionary measures in the operating manual
Connection for potential equalization
Labelling according to Directive 93/42/EEC concerning

medical devices
Manufacturer / date of manufacture
Information on disposal
Application part type B

Symbol Description
Follow the operating manual
Disconnect the mains plug before opening the housing
General warning against risks
Warning against inflammability
Warning against operation in areas at risk of explosion
Warning against dangerous voltage
Do not cover
No mobile phone use
Protect against damp
Warning against risk of explosion
Warning against acid burning

5 Operation and Display
5.1 Operating structure concept
5.1.1 Operating options
1 Touch screen
The touch screen permits direct operation of the

ventilator by touching defined buttons on the graphic
user interface.
2 Fields in the lower section of the touch

screen are operated with the buttons 5-1
underneath.
3 the button /-control panel incremental

encoder (combined with a push button and
selection dial)

5.1.2 Buttons
Manual breath
O2-flush
Cursor buttons
These buttons serve as control in several menus
Screen contrast setting
Menu / calibration
Opening setting and calibration menu. By pressing once you reach the
calibration menu, by pressing again the configuration menu is opened.
Curves/loops
… switches to the curve-/loop display.
Home
… switches to the main display
Alarm limits
On / off – start / stop

… for switching the device on and off
… stopping and resuming ventilation.
Mute alarm
… for acknowledging and muting alarms for a maximum duration of 120
seconds.
Subsequent alarms with higher priority are only displayed optically during
muting.
5.1.3 Incremental encoder

The incremental encoder combines a push button with a selection dial for
performing various setting, selection and confirmation options.

5.2 Display concept structure
5.2.1 Display areas
The information system consists of two main display

areas:
1 Screen
2 LED display
5-2
5.2.2 Screen
Depending on the presentation or menu

chosen, the screen shows various information,
setting and display fields:
1 information bar
 battery status
 date-/time display
 status information,
 System information
 alarm information 5-3
2 graphic field
3 function fields
4 selection or display of operating mode
5 numeric field / alarm limits
Depending on the display mode selected,
individual fields are faded in or out.
Possible display fields are described later.

5.2.3 Information bar
The information bar is for displaying general information including the presentation of alarms.
5-4
Among other things, the following information is

displayed:
5-5
1 - Neonatal or pediatric mode
- patient present YES / NO
- Nurse call ON / OFF
- Charging status of battery (remaining life) 5-6
2 - Ventilation mode, information and alarm

display
5-7
3 - Mute alarm (remaining time until alarm is
again active)
- time / date
Pediatric mode
5-8
Neonatal mode
5-9
If the patient symbol is displayed, patient data is stored

in the device that is associated with the current
ventilation operation.
5-10
Ventilation mode /information / and alarm display

… displays the current ventilation mode, provides more
information if required and notes on the current
5-11
operation.
Furthermore, in the event of alarms the attention of the
user is drawn to the alarm by a flashing color
information line.

5.2.4 Numeric field / alarm limits
... in numeric mode shows the measurement
data relevant to the ventilation mode
selected and its set limits (if any).
The data is refreshed depending on the
ventilation mode as averages/minute or
according to breaths.
The upper and lower limits can be adjusted

manually or automatically in the alarm limit
menu.
5-12
Numeric field
5-13
Alarm limits

5.2.5 Graphic field
… the current pressure, volume or flow measurement
values are shown as a diagram here. You can switch to
the graphic menu with the “Curves/loops”

button.
A maximum of three diagrams can be shown
parallel here.
5-14
Button A: presentation with three curves
As an alternative, you can switch to the loop
presentation.
Here in addition to the loops one of the three line

diagrams can be shown.
LOOP presentation:
 pressure / volumes
 volumes / flow
5-15
Button B: loop presentation

5.2.6 LED display
LED display field
Warning LED
This LED is illuminated or flashes in red if a system
alarm occurs.
Battery LED
This LED shines yellow during battery operation and
green if the battery is fully charged.
The LED flashes in green when the battery is being
charged.
LED mute alarm
This LED lights up in yellow when the alarm is
muted.
The remaining time for the alarm muting is displayed
on the screen.
Mains LED
This LED is shines green during mains operation and
switches off during 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.

5.3 Ventilation menu
5.3.1 Operation – general

Buttons and their conditions are identified by
different coloring:
1 light blue: button
2 dark blue: focused button

5-16
3 yellow (in function menu): measured
parameter
4 green: selected button, if the button has a

parameter for setting a value, this can now
be changed.
5-17
5 orange: parameters are automatically
adjusted by fabian
The value set by the user represents the

maximum value and is not exceeded.
5-18
Depending on the ventilation mode selected, the

settings parameters (4) and measured values (5)
relevant for this mode are shown in the ventilation
menu.
You can switch between pressure, volume or flow
curves (3) with the button (2).
The current information is shown in the information

line (1).
The ventilation mode can be changed via the menu

(6). 5-19

5.3.2 Operation – pre-setting
The ventilation parameters can be pre-set before
starting / activating a ventilation type:
1 touch 1 x for desired ventilation mode

button is displayed yellow
2 the setting parameters for the pre-selected

ventilation mode can now be set
3 touch the pre-set ventilation mode again:

button is shown in green, ventilation with
the pre-set parameters begins. 5-20
Alternatively, the selected parameters can
be confirmed by pressing the incremental
encoder.
If the pre-setting is active (yellow) and no action is

taken for 15 seconds or the pre-selected mode is
not confirmed by changed touch (3), the device
continues to be operated in the previously used 5-21
mode, any pre-settings made are rejected.
5-22
After adopting a parameter, the acoustic alarm is automatically suppressed for

15 seconds.
Immediate activation of the acoustic alarm is possible by pressing the alarm mute
button.
Press any empty area

or another parameter in order to not adopt the altered value and keep the previous value
Alarms which are active before the mode change are automatically reset.

5.3.3 Dependency between ventilation parameters
When parameters regulate one another, an arrow
appears next to the parameter that has to be
changed.
5-23
List of dependent factors:
 O2 flush min. 2 vol.% over set O2, max. 100 vol.%

 only volume limit or volume guarantee possible
 Pinsp min 2 mbar over PEEP
 Pmanuell min 2 mbar over CPAP
 PEEP + PPSV <= Pinsp

5.3.4 Locking of ventilation parameters
Several ventilation parameters are “locked” to
prevent unintentional setting of critical values.
If such a value is reached, this is identified by a key

symbol and there is an audible notice signal.
5-24
The critical value must be reactivated by turning the
knob.
(see table below)
List of locks
Parameter Neonatal Pediatrics

Frequency I:E>1 I:E>1
P Insp > 25 > 25
CPAP > 10 > 10
P PSV + PEEP > 25 > 25
PEEP <2 <2
PEEP > 10 > 10
V guarantee > 30 > 30
V limit > 30 > 30

5.4 Graphic menu
You reach the graphic menu via the curve button of the keypad.
The following presentations are possible in the

graphic menu:
1 curves
2 loops
3 trends
5-25 curves
5-26 loops
5-27
Trends are loaded when the trends key is activated.

5.4.1 Curves
The following curves are displayed in the curve
menu:
 pressure
 flow
 volumes
If autoscaling of the graphic presentation is

switched off, the curve presentation can be
manually scaled:
 select desired curve
 The curve selected is identified by
the symbol.
5-28
 Scale in the X- and Y-directions
with the cursor keys.
Refreshing of the curves is stopped with the key

“Freeze” (1).
The setting parameters and measured values in the

display field (2) continue to be refreshed.
The button is displayed in green.
The curve data are refreshed again by repeated

activation of the key.
5-29
Depending on the ventilation mode selected, the

settings parameters (3) and measured values
relevant for this mode are shown in the graphic
menu.
5-30

5.4.2 Loops
The following loops are available in the loop menu:
 pressure / volumes (P/V loop)
 volumes / flow (V/F loop)
The following parameters of the associated curve in

the upper display area can be selected:
 pressure
 volumes
 flow
5-31
Refreshing of the loops is stopped with the key

“Freeze”.
The setting parameters and measured values in the

display field are only displayed after a loop is saved.
The button is displayed in green.
The loop data are refreshed again by repeated

actuation of the key.
5-32
After a loop has been “frozen”, it can be saved in

order to verify it later with a comparative loop.
Save loop:
 freeze loop
 press “Save” key for three seconds Signal
tone-> loop has been saved
 The loop remains saved until a new loop is
saved.
5-33

Compare loops
1 Switch to loop display screen

2 Freeze current loop
3 Current loop is shown as blue, saved loop is
shown as black.
5-34
5-35

5.4.3 Trend menu
The trend function of the fabian +nCPAP evolution automatically saves an average of the measurement
data every 30 seconds.
Measurement data can be saved over a maximum of five days.
The trend data is automatically deleted in the following cases:
 date and / or time is changed

 new patient data entered
 software update
At any rate, there is a confirmation prompt before the trend data is deleted.
5-36
1 Parameters / selection
2 Graphics
3 Parameter values
4 Time axis
5 Modification of the time axis (max. five days – min. 30 minutes)
6 Refresh data
Moving the time axis with the incremental encoder possible.

6 Preparation for operation
6.1 Establish power supply

Connect the fabian 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.
PLEASE NOTE
The fuses used 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.
6.2 Establish gas supply

Connect the compressed air and oxygen supply tube to the back of the device and to the central gas
supply.
If there is no central gas supply, gas supply from cylinders is also possible.

6.3 Connect tube system
No antistatic or electrically conductive tubes may be used.
The pressure gradient via the breathing system of the ventilator measured at the patient
connection opening can be increased by the attachment of accessory parts or other
components to the breathing system.
1 Connect the inspiration tube to the

connection Insp. (right side)
2 Connect the exspiration tube to the
connection Exsp. (left side)
3 Connect the pressure measurement tube to
the connection Prox. (center)
6-1
Always grasp the tubes on the coupling for
attachment and detachment, since they could
otherwise be damaged.
The exspiration membrane can be easily removed

by turning the membrane holder anticlockwise.
Pay attention to the correct installation position of

the exspiration membrane
The labelling
TOP
must be legible upon installation. See illustration.

6-2

Assemble the tube system according to the
requirements:
 Connect the in-/exspiration tubes and pressure

tube to the Y–piece.
 Connect flow sensor to the Y-piece.
 Connect flow sensor cable to flow sensor.
 Connect plug of the flow sensor cable to the
back of the fabian.
6-3
1 Ventilation tubes
2 Y-piece
3 Flow sensor
4 Flow sensor connection cable
5 Pressure measurement tube proximal
6-4 Flow sensor connection
6.4 Breathing gas humidifier

Prepare the breathing gas humidifier according to the manufacturer's instructions and connect the
tube system.
If the breathing gas humidifier has no inspiration tube heating, water traps should be installed in the
in- and exspiration tube.
If an inspiratory heating is used, a water trap should be installed on the exspiration side.
Ensure that the flow sensor is not exposed to excessive moistening.

6.5 Connect nCPAP tube system
 Connect the nCPAP adapter to the nCPAP

Connect the fabian (art. no.: 7057)
 Connect 22 mm connection of the adapter to the
humidifier chamber.
 Connect the pressure measurement connection of
the nCPAP system to the connection of the fabian
identified with Prox.
 Connect nCPAP system to the humidifier chamber. 6-5
 Apply nCPAP system according to the instructions
of the manufacturer to the patient.
6-6

6.6 Switching on device
The fabian is switched on with the ON / OFF
button.
The start screen appears when you turn on the

device. 6-7
The device self test is carried out.
All acoustic alarms are suppressed for two

minutes after a new start of the device.
6-8
The calibration menu appears after the system

test.
The flow sensor has to be calibrated here.
The automatic O2 calibration begins after leaving

the calibration menu automatically.
However, O2 sensor calibration can already be
carried out.
See also chapter “Calibration.”
6-9

6.7 Switching on device
Disconnect patient.
The fabian is switched off with the ON / OFF button.
Hold down ON / OFF button until the device is 6-10

switched off.
A signal tone is heard after the shut-down process

is complete.
The shut down of the system must be confirmed by

pressing the button “Mute alarm.”
Hold down button for three seconds.

7 Device check fabian evolution
A device check must be carried out before each use of the ventilation device!
What How Target
Gas supply Screw on compressed air and oxygen supply cables Tubes screwed on tight, plug
at the back, insert plug. inserted
Breathing system Membrane holder and membrane Membrane holder and membrane
Tubes correctly installed.
Water traps (if needed) Ventilation system assembled and
Breathing gas humidifier and tube heating connected according to
Flow sensor manufacturer information.
Connect test lung
Switch on test switch on fabian Self-test successful
Alarm tone (loudspeaker) Alarm tone audible during switch-
on test.
Calibration Calibrate flow sensor Calibration successful
Calibrate O2 sensor (occurs automatically after
leaving calibration menu)
Tightness Start CPAP mode Pressure of 80 ± 4 mbar is achieved
CPAP 5 mbar
P manual 80 mbar
Press button manual insp.

Function test Ventilation mode: IPPV Ventilation occurs with the set
I - flow: 10 l/min frequency.
E - flow: 8 l/min
PEEP: 5 mbar P insp.: 20 ±2 mbar
Pinsp: 20 mbar PEEP: 5 ±1 mbar
Frequency: 30 1/ min O2: 30 ±2 vol.%
I-time: 1 sec
Oxygen: 30 vol.%
Alarms Kink inspiration tube. Alarm: inspiration tube kinked.

Kink exspiration tube. Alarm: exspiration tube kinked.
Kink proximal measurement cable Alarm: tube kinked.
Humidifier Fill level Water fill level sufficient.
Function Function OK

8 Configuration menu
You reach the configuration menu by activating the menu / calibration key of the keypad and
subsequent selection of the button “Open menu”.
8-1
1 Calibration ( Flow und O2 ) 6 Date / time
2 Display 7 Tools (e.g. save trend files)
3 Ventilation parameters 8 System information
4 Patient data 9 Service mode
5 Language 10 Close menu (back to previous menu)

8.1 Calibration
8.1.1 O2 sensor calibration
8-2 Calibration
Access to calibration menu also directly via calibration key:
O2 sensor balancing can also be carried out during ongoing operation.

O2 concentration of the inspiration flow to the patient does not change in this
connection.
In the event of the failure of one gas type (oxygen or compressed air), no balancing of
the oxygen sensor is possible.
Manual calibration:
Actuate button “O2 21%” (or O2 100%).
8-3
Following successful calibration, the date of the last

calibration appears in the corresponding field.
The automatic sensor calibration is carried out on

new start and every 24 h.

8.1.2 Flow sensor calibration
8-4 Calibration
Access to the calibration menu also directly via the calibration key:
Ensure no gas flow gets through the flow sensor

during the calibration.
The sensor can be kept closed at both ends for this

purpose. 8-5
Actuate flow – cal key
First the message appears:
“Test running”, then
“Calibration running”
If the fabian is in a mode with trigger function, this is

deactivated for the duration of the calibration.
Following successful calibration, the date of the last

calibration appears in the corresponding field.

8.2 Display
8-6 Display
8-7
1 Lock touchscreen or
2 automatic lock of the touchscreen after pre-set time.
The screen can also be locked by pressing the incremental encoder for > three seconds.
The lock is automatically cancelled in the event of alarm or by pressing the incremental
encoder.
3 Curve presentation filled or line presentation.
4 Automatic scaling ON / OFF

8.3 Ventilation parameters - settings
8-8 Ventilation
8-9 Ventilation parameters page 1
1 Patient area Before setting of the ventilation parameters can begin, the
appropriate area setting must be selected.
2 Alarm delay After falling below the Pmin value, the alarm only occurs after the
delay set here.
3 Tube set Selection of the nCPAP system used.
4 Time limit O2 flush Input of time for O2 flush
5 Automatic oxygen calibration Only with 21 vol% or with 21 vol% and 100 vol%
6 Setting I time or frequency Frequency / I-time or I-time / E-time
7 Maximum time for manual breath Input of inspiration time for manual breath
8 Unit for pressure Selection of pressure unit.
The next page of the ventilation parameters is retrieved with the arrow keys on the lower screen edge

8-9 Ventilation parameters page 2
1 Trigger - mode Selection of trigger mode for assisted ventilation.
2 Termination criterion PSV The PSV breaths are terminated if the inspiratory flow has fallen
by the percentage value of the value previously reached.
3 Volume control Volume guarantee or volume limit
4 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.
5 Factory settings Reset fabian to factory settings
Only carry out resetting to hospital settings or factory settings if no patient is connected
to the fabian.
8.4 Patient data
Patient data Entry of patient data:
Note:
All trend data will be deleted after entering new

patient data.
8.5 Language
Language Selection of user language
8.6 Date / time
Date / Time Entry of date and time:
Note:
All trend data will be deleted after entering new

patient data.

8.7 Tools
Saving trend data Only available if a USB stick is connected.
The trend data are issued in CSV format.
Saving of log files Only available if a USB stick is connected.
Fault diagnosis can be carried out with the assistance of this

data.
8.8 Info
Display of info screen

System information with device-specific data.
8.9 Service mode
Access to the service mode is only possible with password.
Among other things, the hospital settings and nurse call can activated or deactivated.
Please contact your responsible distributor or Acutronic Medical Systems AG for more information.

9 Alarm Limits - Menu
9-1
The following settings can be carried out in the alarm limits menu:
 automatic of individual alarm limits

 alarm volume (can be set at three levels)
 retrieval of log file

Access to alarm limits menu by activating button:
alarm limits
9-2
All alarm limits can be adjusted manually or

automatically in the alarm limits menu.
In the event of an alarm a note appears in the

information bar and the violated alarm limit is
identified with a red bell symbol in the alarm limits
menu.
The acoustic alarm can be suppressed with the

mute alarm button for two minutes.
9-3
The alarm limit can be adjusted manually or automatically.
The corresponding parameters are focused in the alarm limits menu.
(see table of automatic alarm limits)
After the alarm limit has been adjusted or no active alarm still exists, the bell symbol is shown grey.
Inactive alarms must be confirmed with the mute alarm button

9.1 Automatic alarm limits
 MV: 80% above the measured MV

 MV: 50% below the measured MV
 Leak: 10% above the measured tube leak up to the
maximum value of 50% tube leak
 FREQUENCY 50% above measured frequency
 APNOEA: 10 seconds
 Pmax.: 3 mbar above inspiration pressure set
 PEEP: 3 mbar below PEEP set
9.2 Alarm log
The alarm history can be retrieved via the alarm limits menu
The alarm list is structured chronologically.

The following parameters are displayed:
 date / time
 report
 priority color highlighted
The alarm log is deleted when the fabian is switched off.

10 Function Fields - Ventilation Parameters
Inspiration flow Flow can be set during inspiration
Exspiration flow The continuous exspiratory flow can be varied irrespective of the inspiration
flow.
PEEP Pressure in the lung after inspiration has occurred.
Trigger Volume trigger or flow trigger

see “Ventilation parameters”
Inspiration time Setting of inspiration time in seconds
Exspiration time Setting of exspiration time in seconds
Frequency Setting of breathing frequency in cycles per minute
p Insp Inspiration pressure
p PSV Ventilation pressure during inspiration in PSV mode.

Pressure over PEEP
p duo Upper inspiratory pressure in duoPAP mode.
The lower pressure level is selected in the duoPAP mode above the CPAP
parameter.
P manuell Application of a manual breath.

The maximum time can be set in the ventilation parameters.
Changed breathing after a blocking time of 200 ms.
CPAP Continuous flow to generate airway pressure at CPAP level
Back-up In the event of apnoea, stimulation of spontaneous breathing occurs by a

pre-set number of mechanical breaths after expiry of the apnoea period.
The flow sensor must be connected and activated.
Triggering of the back-up depends on the apnoea period set.
O2 Setting of inspiratory oxygen concentration
Oxygen flush Dose of O2-flush / oxygen shower

Pre-oxygenation for max two minutes. Can be set in the ventilation
parameters.
Volume limit Setting of maximum ventilation volume.

The inspiration is terminated on reaching the volume limit.
Volume guarantee The mechanical breaths are volume-controlled with this additional function.
Changes in the ventilatory system are compensated.
As a result, the patient is provided with a guaranteed volume with each
breath.

11 Battery Operation
The fabian evolution is equipped with an internal battery.
Battery life with fully charged battery in IPPV mode: approx.. 3 hours.
These values can vary depending on the parameter setting.

The integrated battery management continuously calculates the remaining life, which is shown in the
information bar.
Reduction in battery life on changing operating mode

Automatic shutdown of ventilator!
Changing the operating mode can greatly shorten the operating mode!
 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 failure of the power supply, the pneumatic system opens
against atmospheric pressure. As a result, no pressure can build up in the
breathing system and spontaneous breathing of the patient is facilitated.

11.1 Failure of the power supply
If the power supply fails, the fabian evolution automatically switches to battery mode without an
interruption.
There is an optical and acoustic information signal.
Mains failure.
This information signal can be confirmed with the mute alarm button.
The fabian evolution monitors battery life

continuously.
Further signals occur at a residual life of:
 30 minutes
 15 minutes
 60 minutes, only if upon failure of the power
supply the residual life is less than 60 11-1
minutes.
If the residual life is less than one minute, there is a

warning signal indicating that first aid has to be
established immediately.
After this the battery capacity is exhausted and the

fabian evolution switches off.

11.2 Operation with external power supply
External power supply available from HW Rev. 1.1

With HW Rev. 1.0 use only with connection cable Part. No. 7272
The fabian evolution can likewise be operated with an external power supply.
An external supply with a voltage of 12 – 24 volts must be connected to the back of the device in this
case.
Rear connection of the external power supply.
11-2
11-3

12 Ventilation Modes
Depending on configuration, the fabian evolution is equipped with the following ventilation modes.
 IPPV
Controlled ventilation with prescribed ventilation patterns
Breath volume can be pre-set or limited
 S – IPPV
Controlled ventilation with pre-set ventilation patterns.
The inspiration is synchronized with each spontaneous breath of the patient.
 S - IMV
The patient can breathe spontaneously between the mandatory mechanical breaths.
 PSV
Synchronized ventilation form with pre-set inspiration pressure.
S-IMV + PSV
The patient can breathe spontaneously between the mandatory mechanical breaths; these
mechanical breaths are supported by the PSV.
 CPAP
Spontaneous breathing under positive airway pressure
 nCPAP / duoPAP
NIV-ventilation with special nCPAP systems.
The following nCPAP systems are supported (as of 07/2012):
- Medijet ®
- Infantflow ®
- Infantflow LP ®
 O2 therapy
Oxygen supplementation via oxygen masks, nasal cannula or hood.

12.1 IPPV ventilation
In IPPV mode (Intermittent Positive Pressure

Ventilation )ventilation occurs with patterns set
and prescribed in the device without taking any
spontaneous breathing of the patient into
consideration.
In this case, overpressure is generated in the

inspiration phase with the exspiration
occurring passively.
see also Function fields and ventilation parameters

see also: Ventilation supplements

12.2 S IPPV ventilation
In the trigger mode Synchronized Intermittent

Positive Pressure Ventilation) each
spontaneous breath of the patient activates a
mechanical breath of the ventilator with the
ventilation parameters set for inspiration time
and –pressure.
The number of mechanical breaths per minute
supported by the ventilator is regulated by the
patient. To avoid hyperventilation, the
breathing frequency of the patient must be
precisely monitored in this mode.
see also: Function fields and ventilation parameters


12.3 S IMV ventilation
Ventilation with pre-set patterns and pre-set

frequency in synchrony with the patient’s own
breathing.
The patient can breathe spontaneously
between the mechanical breaths, but does not
receive any pressure support.
To wean off ventilation.
If apnoea is determined, ventilation with the

frequency determined by TI and TE
commences.
To avoid self-triggering (autotrigger) no

additional mechanical breath can be triggered
for 200 ms after a mechanical breath.
A triggered mechanical breath is shown in green in

the display.
12-1


12.4 S IMV + PSV ventilation
In SIMVmode + PSV (Synchronized Intermittent Mandatory Ventilation + Pressure Support Ventilation )
the patient can trigger a PSV breath between the mandatory SIMV mechanical breaths.
In addition, the ventilator is synchronized with the ventilation pattern of the patient.
If the patient is not breathing on their own, mechanical ventilation occurs with the pre-set ventilation
parameters. If the patient is breathing spontaneously, the device synchronizes with a PSV breath.
A triggered mechanical breath is shown in green in

the display.
12-2
The inspiratory pressure for the PSV breath is set with the key P PSV.
In relation to PEEP pressure.
The PSV breath is terminated if one of the following criteria is met:
 the airway pressure exceeds a pre-set pressure P INSP

 the inspiratory flow has fallen to xx% of the previously-attained maximum value.
XX = value according to settings menu


12.5 PSV ventilation
The Pressure Support Ventilation – option is for  the airway pressure exceeds a pre-set
pressure support of insufficient spontaneous pressure P INSP
breathing among the triggered ventilation  the inspiratory flow has fallen to a set
types. The breathing frequency is determined % value of the previously achieved
by the spontaneously breathing patient; the maximum value (this indicates an
ventilator assumes an adjustable proportion of almost full lung)
the breathing work.
As a result, the inspiration is determined by the If the patient is no longer spontaneously
patient and occurs according to the breathing, the ventilator assumes substitute
parameters set in the ventilation type SIMV or ventilation wit the ventilation parameters set.
ASSIST. But the ventilator now decides on the
exspiration. This occurs as soon as one of the
following criteria is met:


12.6 CPAP
In the case of CPAP ventilation the patient breathes spontaneously. The ventilator does not perform
any breathing work. All that happens is that both during inspiration as well as exspiration positive
pressure is generated as a result of which the breathing work of the patient is greatly reduced. The
maximum automatic leak compensation is 50% of the inspiration flow.
If the spontaneous breathing of the patient stops, the ventilator takes a pre-set number of mechanical
breaths after expiry of the apnoea period in order to restimulate spontaneous breathing. When the
latter begins, the stimulation is terminated and only restarts after changed apnoea.


12.7 nCPAP / duoPAP
In nCPAP / duoPAP mode the patient breathes spontaneously through a mask or nasal cannula. Since
no flow sensor is connected, additional apnoea monitoring must be used, e.g. impedance
measurement.
Additional monitoring of SpO2 and PCO2 is recommended.
nCPAP: Provides positive airway pressure with automatic leak compensation. The maximum flow
compensation is 25%.
duoPAP: Like nCPAP, but with the option of positive pressure ventilation with adjustable frequency and
inspiration time.
In this mode a special nCPAP patient set is needed with nCPAP generator.
The appropriate system must be selected in the configuration menu before using
the nCPAP / duoPAP modes.
The following systems are currently available:
 Medijet ®
 Infantflow ®
 Infantflow LP ®
siehe auch : Function fields and ventilation parameters


12.8 O2 therapy
The O2 therapy mode is for oxygen supplementation.
The O2 concentration and flow parameters can be set.
Oxygen masks, nasal cannula or hoods can be used for O2 therapy.
The pressure measurement connection “Prox.” can be used for pressure measurement.
The pressure measured is displayed in the curve menu.
There is no monitoring of the ventilation pressure in O2 therapy mode.

Patient alarms are NOT active.
Masks for non-invasive (NIV) ventilation are not suitable.

Use only oxygen masks, nasal cannula or hoods

12.9 Ventilation supplements
The following additions can be combined with the mode selected to optimize ventilation.
12.9.1 Volume limit
The volume limit function switches automatically to exspiration if the set tidal volume is reached.
If the ventilation pattern is changed or the volume limit adjusted, the tidal volume is automatically
limited.
The message appears in the display:

“Volume limited”
If the flow measurement fails (e.g. sensor change), “V limit” is automatically deactivated.
As soon as the flow measurement is again available, “V limit” is automatically reactivated.

12.9.2 Volume guarantee
The volume guarantee is a pressure-limiting additional function with guided or targeted tidal volume
application.
Select the volume to be applied in the field “V guarantee.”

The fabian evolution automatically sets the ventilation pressure P insp. required automatically.
Pinsp. is increased compared to the user setting by 5 mbar.
The field P insp. is shown orange highlighted.
A red line in the graphic display shows the upper pressure limit.
If the pre-set P insp. for the application of the ventilation volume is insufficient, the message
appears: “Volume not reached”
If the flow measurement fails (e.g. sensor change), “V guarantee” is automatically

deactivated.
As soon as the flow measurement is once again available, “V guarantee” is automatically
reactivated.

12.10 Special functions
12.10.1 Starting inspiration manually

In almost all screens by pressing the button
“manual inspiration” a manual breath (with the
ventilation parameters set in the current ventilation
mode) can be triggered.
The duration of the manual breath can be set in the

configuration menu - > Ventilation.
This can last 2 – 10 seconds, after which there is a
mandatory termination of the manual breath.
A changed manual breath is only possible after a
blocking time of 200 ms.

12.10.2 Nebulizing medicines
The wires of the flow sensor are hot.

If the flow sensor is left in the breathing system for a lengthy period during nebulization
and not cleaned, deposits can form as a result of the medicinal aerosols and impair flow
measurement.
In the worst case, these deposits can ignite!
Disconnecting the plug of the flow sensor is not enough to prevent this.
Consequently, remove the flow sensor before medicine nebulization.

12.10.3 O2 flush / pre-oxygenation
An O2 flush can be triggered with the key “O2 flush.”
A brief O2 flush with increased O2 concentration is

possible in all ventilation modes.
This is terminated automatically after a maximum of
two minutes.
(see also pre-settings in menu: Configuration - >
Ventilation - > Flush time)
Actuate the button “O2 flush” in a ventilation mode

the O2 flush begins.
The flush concentration can now be set via the
incremental encoder.
Pressing the O2 button again terminates the flush
early.

12.10.4 Standby – stopping mechanical ventilation
Mechanical ventilation can be interrupted for two

minutes with the button “Start / Stop.”
Hold down the key for about three seconds.

Observe messages on the screen (information bar)
Pausing ventilation for an unlimited period exists as

an option in the nCPAP and duoPAP modes.
In both cases the integrated gas blender provides a

slight flow to avoid any heat accumulation in the
breathing gas humidifier.
Ventilation resumes after the two-minute pause has

expired or by pressing the key again.
Danger of oxygen undersupply!

The standby function is not intended for the suction process.
There is no recognition of disconnection or reconnection.

13 Error – Cause – Remedy - Alarms
Alarms are divided into three priority levels: high, medium and low. These are differently indicated
optically and acoustically according to priority.
I=HIGH red highlighted, flashing message Tone sequence: ♪♪♪-♪♪-♪♪♪-♪♪
II=MEDIUM yellow highlighted, flashing message Tone sequence: ♪♪♪
III=LOW yellow highlighted message Tone sequence: ♪
The messages are in alphabetical order in the table.

In the event of an alarm message, the table is intended to help recognize and eliminate the cause.
Alarm name Cause Remedy Priority

O2 sensor or blender Renew O2 sensor or use
Deviation oxygen value defective. Acutronic Service. I
Establish mains supply.
Alarm can be confirmed with
mute alarm.
Remaining battery life < 15 fabian works without
Charge battery (< 15 min.) min. interruption in battery mode. I
Establish mains supply.
mute alarm.
Remaining battery life < 30 fabian works without
Charge battery (< 30 min.) min. interruption in battery mode. I
Remaining battery life < 1 Establish mains supply
Battery empty! min. immediately I
Spontaneous breathing of
Apnoea patient stops Begin controlled ventilation. I
Breathing frequency too Hyperventilation Set frequency
high Self-trigger Raise trigger threshold II
Checksum ERROR System error Use Acutronic Service I
Checksum ERROR System error Use Acutronic Service I
COM-read/write error System error Use Acutronic Service I
DIO-read/write error System error Use Acutronic Service I
Check tube system tightness.
Disconnection Leakage or disconnection Check setting for Pinsp. I
Pressure increase in the
tube system, mechanical
inspiration was shortened Check tube system.
Pressure too high to relieve the system. Replace patient system. I

Leakage or disconnection Check tube system tight
Insp. flow or exsp. flow set connection.
Pressure too low too low. Increase flow. I
Input pressure air supply Air supply pressure too low. Ensure pressure 2 bar higher. I
Oxygen supply pressure too
Input pressure O2 supply low. Ensure pressure 2 bar higher. I
Heating wires in flow Change flow sensor.
Flow sensor defective sensor damaged. Carry out calibration. I
Flow sensor is not
connected. Check flow sensor and sensor
Flow sensor not connected. Sensor cable defective cable connection. I
Water or secretion in flow Clean / change flow sensor
Clean flow sensor sensor Carry out calibration. I
I2C read-/write error System error Use Acutronic Service I
Check tube system tight
Inspiration pressure not Leakage. connection.
attained Flow too low. Increase flow. III
Lung compliance has
increased.
Resistance has decreased.
Minute volume too high Hyperventilation. Check ventilation setting. II
Lung compliance has
decreased.
Resistance has increased.
Spontaneous breathing
Minute volume too low stops or becomes less Check ventilation setting. II
Proportional blender or
Blender defective control defective Use Acutronic Service I
Establish power supply.
mute alarm.
fabian works without
Power failure Power failure interruption in battery mode. III
Establish power supply.
Power failure. Alarm can be confirmed with
Remaining life of internal mute alarm.
Power failure / charge battery less than 60 fabian works without
battery (< 60 min) minutes. interruption in battery mode. III
O2-sensor calibration error Error during calibration. Carry out calibration again. I
PEEP 6 mbar above value Check tube system.
PEEP high set for min. 15 seconds. Check patient connection. I
PIF read/write error System error Use Acutronic Service I
Oxygen sensor defective O2 sensor is defective. Renew O2 sensor. I

Renew O2 sensor as quickly as
possible.
Oxygen sensor exhausted O2 sensor exhausted. Calibration still possible. I
Ventilation tube or pressure
measurement tube blocked
Tube kinked. or kinked.
Safety relay defective Safety relay defective. Use Acutronic Service I
Voltage monitoring System error Use Acutronic Service I
SPI read/write error System error Use Acutronic Service I
Tube blocked Tube kinked or blocked. Create free passage. I
upper boundary alarm limit Adjust threshold value.
Tube leak too high exceeded Check tube system. II
upper boundary alarm limit
Volume limited exceeded Adjust settings. II
Adjust inspiration pressure
setting.
Inspiration pressure setting Increase inspiration time.
Volume not reached reached prematurely. Change volume guideline. II
Too little RAM memory System error Use Acutronic Service I

14 Changing Oxygen Sensor
1. Loosen the screws to open the O2-sensor

flap.
2. Remove the cable from the O2-sensor.
3. Unscrew the O2-sensor.
4. Replace it with a new sensor.
5. Connect the O2-sensor with the plug

14-1
6. Connect the O2-sensor flap and retighten
the screws
Switch on fabian.
Calibrate the oxygen sensor at 22 vol. % and 100 vol.
%.
When installing a new factory sensor changed calibration can be necessary after about
30 minutes.
If possible, expose the new sensor for about 30 minutes to the ambient air BEFORE start-
up.
The exhausted O2-sensors must be disposed of professionally. The following must be borne in mind in
this connection:
Do not throw O2-sensor into the fire – explosion risk!
Do not open O2-sensors violently – risk of chemical burns!
Dispose of O2-sensors according to the local waste disposal regulations

(cf. battery disposal).
The local environmental or regulatory agencies and suitable disposal companies will provide
information.

15 Maintenance Intervals
Clean and disinfect device or device parts before each maintenance measure – including return of the
device for repair purposes.
Every six months

The following work must be carried out:
 Clean, if necessary replace cooling air filter (in housing lid)
Every twelve months

Maintenance and safety check
The following work must be carried out:
 Check pressure connections
 Check electrical connections
 Check alarm and threshold value functions
 Verification and validation of flow, volume and pressure values
 Check safety shutdowns
 Calibration of pressure sensors
 Calibration of breathing out valve
The following components must be replaced:

 Air and oxygen input filter
 Air filter (housing lid)
 O2 sensor
Every four years

The following components must be replaced:
 Air and oxygen input filter
 Air filter (housing lid)
 O2 sensor
 Poportional valves compressed air / oxygen blender
 Input pressure regulator compressed air / oxygen
 Calibration valves
 Lithium battery for data back-up
Maintenance and the safety check may only be carried out by specialists trained by
Acutronic, who have suitable measuring equipment and test facilities.

16 Preparation / Cleaning / Disinfecting
The device must be prepared after each patient treatment.
The device may not be sterilized under any circumstances!
Only wet disinfection, e.g. with Buraton 10 F or Terralin (Schülke & Mayr, Norderstedt, Germany) may
be carried out. The application regulations of the manufacturer must be observed in this regard.
In general, the tube system must be changed after each patient treatment to avoid contamination of
succeeding patients.
The following procedures can be used in this regard:
Sterilization of accessories:
Flow sensor
Rinse sensor immediately after use with warm water and then in cleaning solution, like: :
Insert Neodisher Mediclean forte ( Dr. Weigert Germany ), since otherwise encrusting may occur as
a result of which the function of the sensor is no longer guaranteed.
Next disinfect sensor e.g. with:

Gigasept Instru AF
 Do not clean sensor with compressed air or a hard

 water jet, since otherwise the sensor wires could be destroyed. Never treat sensor in
automatic cleaning-/disinfection machine.
Steam sterilization at 134°C (+3°) at 220 kPa for five minutes
The flow sensor should be changed after 30 treatment cycles.
Replace and clean sensor once a day.

It has been shown in practice 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.

Membrane holder with membranes
Clean and disinfect wet thermally (93°C / 10 min) in the automatic cleaning/disinfection machine just
with detergent.
Steam sterilization at 134°C (+3°) at 220 kPa for five minutes

The exspiration membrane should be changed after 30 treatment cycles.
In general, sterilize the membrane holder to ensure that residual water in the channels and control
cables dries out.
Sterilization of accessories
Ventilation tubes
Preparation according to manufacturer information
Heating wire
Water trap
Temperature sensor
Y-piece

17 Technical Data
As of: 10/2012 Hardware Rev. 1.0
17.1 Ambient conditions

In operation
Temperature 10 - 40°C ( 50 – 104 °F )
Air pressure 700 - 1060 hPa
Relative humidity 10 – 90%, not condensating
During storage and transport
Temperature -20 - 60°C ( -4 – 104 °F )
Air pressure 500 - 1060 hPa
Relative humidity 10 – 95%, not condensating

17.2 Setting ranges and parameters
Mode
IPPV SIPPV
Neonatal Pediatrics Neonatal Pediatrics

Parameters
min max min max min max min max
I-flow [l/min] 1 20 2 32 1 20 2 32
E-flow [l/min] 2 20 4 20 2 20 4 20
I-time [sec] 0.1 2 0.3 2 0.1 2 0.3 2
E-time [sec] 0.2 30 0.2 30 0.2 30 0.2 30
Frequency [1/min] 2 200 2 100 2 200 2 100
PEEP [mbar] 0 30 0 30 0 30 0 30
Pinsp [mbar] 4 80 4 80 4 80 4 80
Trigger* (volume) 1 20 1 20
Vlimit [ml] 1 150 10 500 1 150 10 500
Vgarant [ml] 2 200 10 500 1 200 10 500
O2 [%] 21 100 21 100 21 100 21 100
O2 flush [%] 23 100 23 100 23 100 23 100
*Flow trigger: 0.120 – 2.4 l/min
Mode
SIMV SIMV+PSV

Parameters
I-flow [l/min] 1 20 2 32 1 20 2 32
E-flow [l/min] 2 20 4 20 2 20 4 20
I-time [sec] 0.1 2 0.3 2 0.1 2 0.3 2
E-time [sec] 0.2 30 0.2 30 0.2 30 0.2 30
Frequency [1/min] 2 100 2 100 2 100 2 100
PEEP [mbar] 0 30 0 30 0 30 0 30
Pinsp [mbar] 4 80 4 80 4 80 4 80
PPSV [mbar] & PEEP 2 80 2 80
Trigger (volume) 1 10 1 10 1 10 1 10
Vlimit [ml] 1 150 10 500 1 150 10 500
Vgarant [ml] 2 200 10 500 2 200 10 500
O2 [%] 21 100 21 100 21 100 21 100
O2 flush [%] 23 100 23 100 23 100 23 100

Mode
PSV CPAP

Parameters
I-flow [l/min] 1 20 2 32
E-flow [l/min] 2 20 4 20
I-time [sec] 0.1 2 0.3 2
E-time [sec] 0.2 30 0.2 30
Frequency [1/min] 2 200 2 100
PEEP [mbar] 0 30 0 30
Pinsp [mbar] 4 80 4 80
PPSV [mbar] & PEEP 2 80 2 80
Trigger 1 10 1 10
Vlimit [ml] 1 150 10 500
Vgarant [ml] 2 200 10 500
O2 [%] 21 100 21 100 21 100 21 100
O2 flush [%] 23 100 23 100 23 100 23 100
Flowmin [l/min] 4 16 4 16
CPAP [mbar] 1 30 1 30
Pmanual [mbar] 4 80 4 80
Back-up 0 5 0 5
Mode
NCPAP DUOPAP O2 Therapy

Parameters
min max min max min max min max min max min max
I-time [sec] 0.15 15 0.15 15
E-time [sec] 0.2 30 0.2 30
Frequency [1/min] 2 60 2 60
O2 [%] 21 100 21 100 21 100 21 100 21 100 21 100
O2 flush [%] 23 100 23 100 23 100 23 100
Flowmin [l/min] 0 15 0 32
CPAP [mbar] 2 13 2 13 2 13 2 13
Pmanual [mbar] 5 15 5 15
PDUO [mbar] 5 15 5 13

17.3 Precision of measured value display
Airway measurement
Range: - 10 – 110 mbar

Precision: ±4%
Resolution: 0.1 – 1 mbar
Breath volume measurement
Range: 0 – 9.99 l ( BTPS )

Precision: ±8%
Resolution: 0.1 – 100 ml
Tube leak
Range: 10 – 50%
Precision: ±10%
Resolution: 1% ml
Dynamic compliance
Range: 0-500 ml/mbar

Precision: ±8%
Resolution: 0.1 – 1 ml/mbar
Resistance
Range: 0 – 5000 mbar/l/s

Precision: ±8%
Resolution: 0.1 mbar/l/s
Inspiratory O2 concentration
Range: 18 – 100 vol%

Precision: ± 3%
Drift: < 1 vol% per month. < 15% rel. over entire service life
Pressure influence Proportional to change in partial pressure
Warm-up time: max. three minutes (< 30 minutes with new O2 sensor )

17.4 Monitoring
Acoustic pressure of alarm tones

Free field measurement ISO 3744
Alarm tone sequence IEC
High priority: 49 db(A) – 65 db(A)
Medium priority: 49 db(A) – 63 db(A)
Low priority: 48 db(A) – 63 db(A)
Exspiratory minute volume
Alarm lower threshold value: If lower alarm limit undershot

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

Alarm upper threshold value: If upper alarm limit exceeded
maximum airway pressure: 100 mbar
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
Volume monitoring
Alarm lower threshold value: If the breath volume set was not supplied
Apnoea alarm
Alarm: If no breathing activity is recognized

17.5 Resistance values
System resistance: < 20 mbar/l/s at 30 l/min

Inspiratory resistance: < 12 mbar/l/s
Exspiratory resistance: < 8 mbar/l/s
17.6 Pre-set parameters

Tube set nCPAP configurable  Medijet ®
 Infantflow ®
 Infantflow LP ®
O2 flush – time  30 seconds

 60 seconds
 120 seconds
Automatic O2 calibration  21 vol%

 21 vol% and 100 vol%
Settings I - time  Frequency / I – time

 I- time / E - time
Manual breath  2 – 10 seconds
Filter volume guarantee  2 – 10 breaths
Trigger mode  Volume trigger

10 – 25% Vte
 Flow trigger
0.120 – 2.4 l/min
Signal tone triggered breath  With signal tone

 Without signal tone
Termination criterion PSV  5 – 70%
Alarm delay P min. nCPAP  1 – 10 seconds
Signal tone V limit  ON

 OFF

17.7 Dimensions / weight
BxHxT 24 cm x 27 cm x 35 cm
Weight about 10 kg
17.8 Operating values

Compressed air supply 2.0-6.5 bar
max. 40 l/min
Connection thread: NIST
Oxygen supply 2.0-6.5 bar

max. 40 l/min
Connection thread: NIST
Dew point 50C ( 41 0F ) below ambient temperature
Oil content < 0.1 mg/m3
Particle size Dust-free air, filtered with pore size <1 µm

Gas consumption Depending on ventilation modes selected.
plus 2 l/min for O2 measurement
Automatic gas switch In the event of a gas failure, there is an

automatic switch to the remaining gas
Power supply 100-240 VAC / 0.2A
50/60Hz
external: 12 -24 VDC
Power consumption IPPV mode : max. 70 W
Stand-by, fabian on mains: 35 W
(battery charging)
Internal battery Type: NiMH Maintenance free

13.2 V / 4.5 Ah
max. charging time: five hours
Fuse: 1 A
Operating time if no mains supply with fully charged at least three hours
internal battery
Acoustic pressure ≤ 42 dB ( A )
Device fuse T 630 m A L
Protection class Type B body ≙ EN 60601-1
Classification according to EC Directive 93/42/EEC Class II b

UMDNS code 14 - 361

17.9 Device outputs
- Nurse call (galvanically separated)

- Flow sensor (galvanically separated)
- External trigger (galvanically separated)
- Medicine nebulizer
Serial RS232 interface
PIN
1 DCD
2 RXD
3 TXD
4 DTR
5 GND
6 DSR
7/8 RTS / CTS
9 5V for CO2 sensor
17.10 Data storage

Trend Maximum five days
Storage every 30 seconds
Alarms Maximum 1,000 reports

17.11 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.
Figure 2: Proportional blender – simplified diagram

18 Accessories
Art. no. Designation
7052 Membrane holder, 22 mm AD / 15 mm ID
7007 Membrane, exspiration
7003 Oxygen sensor
1016 Flow sensor connection cable
1031 Flow sensor, reusable
7085.1 Flow sensor, disposable
5131 Water trap AIR NIST
7063 Trolley for fabian
7060 Mounting plate for fabian evolution
3590 Ventilation tube holder for rail attachment
You can obtain a complete accessories catalogue from your distributor or direct from Acutronic
Medical System AG

19 Annex

19.1 Explanation of electromagnetic compatibility
Note
The “fabian” device is an ELECTRICAL MEDICAL DEVICE, which is subject to special precautionary
measures regarding EMC and which must be installed and put into operation according to the
information included in this document.
Warning
Portable, mobile HF communication facilities can influence ELECTRICAL MEDICAL DEVICES!
Warning
The “fabian” device may not be stacked, arranged or used directly next to or with other devices.
However, if this is required, it is necessary to monitor this in order to check operation as intended in
these instructions.
Warning
The use of other accessories, cables or transformers with the “fabian” device can lead to increased
disturbance output and a reduction of the disturbance resistance of the “fabian.”
Note
The main features of the “fabian” ventilator are:
- The fabian must function within the defined specification and its medical purpose. If the
specifications are not complied with, ventilation is stopped.
- For this reason a second, independent ventilation facility must be kept ready, e.g. air-mask bag unit.

Guidelines and Manufacturer’s Declaration – Electromagnetic Emissions
The “fabian” device is intended for operation in the environment stated below. The customer or user of the “fabian” device should make
sure that it is operated in such surroundings.
Disturbance emission
Compliance Electromagnetic surroundings - guidelines
measurements
The “fabian” device uses HF energy exclusively for its internal functions.
HF emissions
Group 1 Consequently, its HF emissions are very low and it is unlikely that neighboring
CISPR 11
devices will be disturbed.
HF emissions
Class A
CISPR 11
Emission of overtones
Class A
IEC 6100-3-2 The “fabian” device is suitable for use in all other areas apart from the
residential area and apart from those areas that are connected directly to a
public supply grid which also supplies buildings used for residential purposes.
Emission of voltage fluctuations /
flicker Met
IEC 6100-3-3
Guidelines and Manufacturer’s Declaration – Electromagnetic Emissions

The “fabian” device is intended for operation in the environment stated below. The customer or user of the “FABIAN” device should make
Disturbance emission Compliance Electromagnetic surroundings - guidelines

measurements
The “FABIAN” device uses HF energy exclusively for its internal functions.
HF emission
Group 1 Consequently, its HF emissions are very low and it is unlikely that
CISPR 11
neighboring devices will be disturbed.
HF emission
Class A
CISPR 11
Emission of
overtones IEC N/a
61000-3-2
Emission of voltage
fluctuations / flicker N/a
IEC 61000-3-3

Guidelines and Manufacturer’s Declaration – Electromagnetic Disturbance Resistance
IEC 60601
Disturbance resistance test Compliance level Electromagnetic surroundings - guidelines
testing level
Electrostatic discharge Floors should be wood or concrete or have ceramic tiles. If
(ESD) the floor is fitted with synthetic material, the relative
± 6 kV contact ± 6 kV contact humidity must be at least 30%.
IEC 61000-4-2 ± 8 kV air ± 8 kV air
Electrical fast The mains quality should correspond to the typical

transient/burst ± 2kV for power surroundings of businesses or hospitals.
cables ± 2kV for power cables
IEC 610004-4
± 1kV for in-/output ± 1kV for in-/output cables
cables
Surge voltage ± 1 kV Cable to The mains quality should correspond to the typical
cable ± 1 kV Cable to cable surroundings of businesses or hospitals.
IEC 61000-4-5
± 2 kV Cable to ± 2 kV Cable to ground
ground
Voltage dips, temporary The mains quality should correspond to the typical
interruptions and surroundings of businesses or hospitals. If the user of the
fluctuations of supply <5% UT “fabian” device requires continuous use during a mains
voltage (>95% Dip of UT) <5% UT interruption, it is recommended that the “fabian” device is
for (>95% Dip of UT) for supplied via an uninterruptible power supply or a battery.
IEC 61000-4-11 ½ period ½ period
40% UT 40% UT
(60% Dip of UT) for (60% Dip of UT) for
5 periods 5 periods
70% UT 70% UT
(30% Dip of UT) for (30% Dip of UT) for
25 periods 25 periods
<5% UT <5% UT
(>95% Dip of UT) (>95% Dip of UT) for
for 5 seconds
5 seconds
Magnetic field in supply 3 A/m 3 A/m Magnetic fields in the mains frequency should have typical
frequency values that comply with what is to be found in business
(50/60 Hz) and hospital surroundings.
IEC 61000-4-8
Note UT is the mains alternating voltage before application of the test level.

Guidelines and Manufacturer’s Declaration – Electromagnetic Disturbance Resistance
Disturbance IEC 60601
Compliance level Electromagnetic surroundings - guidelines
resistance test testing level
Portable, mobile radio devices should not be used at any distance closer to
the “fabian” device, including the cables, than the recommended
protective distance calculated according to the equation appropriate for
the transmission frequency.
Recommended protective distance

HF disturbance 10 V d = 0.35√P
current 3 Veff
IEC 61000-4-6 150 kHz to 80 MHz
outside of ISM
bands a 10 V d = 1.2√P
10 Veff
150 kHz to 80 MHz
in the ISM bands b
HF-Stray 10 V/m 10 V/m d = 1.2√P 80 MHz to 800 MHz

radiation 80 MHz to 2.5 GHz
IEC 61000-4-3 d = 2.3√P 800 MHz to 2.5 GHz
with P as the nominal output of the transmitter in Watt (W) according to the
information of the manufacturer and d as recommended protective
distance b in meters (m).
The field strength of stationary radio transmitters in all frequencies

according to an investigation on the sport should be c less than the
compliance level d.
Disturbance is possible in the environment of devices bearing the following

pictograph:
NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2 These guidelines may not be applicable in all cases. The propagation of electromagnetic factors is influenced by absorption and
reflection of buildings, objects and people.
a
Die 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.
b
The compliance level in the ISM frequency bands between 150 kHz and 80 MHz and between 80 MHz and 2.5 GHz were established to
ensure that the probability was reduced that mobile/portable transmitting equipment would produce disturbance in case it was
brought into the patient’s surroundings by mistake. For this reason an additional factor of 10/3 was used in calculating the
recommended protective distance for transmitters in this frequency range.
c
The field strength of stationary transmitters, such as base stations of radio telephones (mobile/cordless) and mobile terrestrial radio
equipment, amateur radio stations, AM and FM radio and TV broadcasters cannot be precisely predicted in theory. A study of the
location should be considered to determine the electromagnetic surroundings with regard to stationary transmitters. If the field
strength measured at the location where the “FABIAN” is used exceeds the compliance level above, the “FABIAN” device should be
observed to determine function as intended. If unusual features are observed, additional measures may be necessary, such as altered
orientation or another location of the “FABIAN” device.
d
The field strength should be less than 10 V/m across the frequency range from 150kHz to 80MHz.

Recommended Protective Distances between Portable and Mobile HF Communications Equipment
and the “fabian” Device
The “fabian” device is intended for operation in an electromagnetic environment in which HF disturbance factors are controlled. The
customer or user of the “fabian” device can help to avoid electromagnetic disturbances by complying with the minimum distance between
portable, mobile HF telecommunications devices (transmitters) and the “fabian” device – depending on the output power of the
communications device as stated below.
Protective distance depending on transmission frequency

m
Maximum nominal power of 80 MHz to 800 MHz 800 MHz to 2.5 MHz
the transmitter 150 kHz to 80 MHz
150 kHz to 80 MHz
W inside
outside of ISM bands a
ISM bands
d = 0.35√P d = 1.2√P d = 1.2√P d = 2.3√P
0.01 0.04 0.12 0.12 0.23
0.1 0.13 0.38 0.38 0.73
1 0.40 1.2 1.2 2.3
10 1.3 3.8 3.8 7.3
100 4.0 12 12 23
For transmitters whose maximum nominal power is not stated in the above table, the recommended protective distance d in meters (m) can
be determined using the equation belonging to the respective column with P being the maximum nominal power of the transmitter in Watt
(W) according to the information of the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz the protective distance for the higher frequency range applies.
NOTE 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.
NOTE 3 An additional factor of 10/3 was used in calculating the recommended protective distance for transmitters in the ISM frequency
range between 150KHz and 80 MHz and between 80MHz and 2.5GHz to reduce the probability that mobile/portable transmitting equipment
would produce disturbance if they were brought into the patient’s surrounding by mistake.
NOTE 4 These guidelines may not be applicable in all cases. The propagation of electromagnetic factors is influenced by absorption and
reflection of buildings, objects and people.

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Operating Manual

Before making use of the ventilator users must

ACUTRONIC Medical Systems AG

Operating Manual fabian + nCPAP evolution 2 / 95

The header on each page is for quick orientation

Left side of the page

Right side of the page...

3 / 95 Operating manual fabian + nCPAP evolution

3 General Notes .................................................................................................................................... 10

4 System Overview ............................................................................................................................... 15

5 Operation and Display ...................................................................................................................... 20

6 Preparation for operation ................................................................................................................ 36

7 Device check fabian evolution........................................................................................................ 42

8 Configuration menu ........................................................................................................................... 43

9 Alarm Limits - Menu .......................................................................................................................... 51

10 Function Fields - Ventilation Parameters ...................................................................................... 54

5 / 95 Operating manual fabian + nCPAP evolution

12 Ventilation Modes ............................................................................................................................. 58

13 Error – Cause – Remedy - Alarms .................................................................................................. 73

14 Changing Oxygen Sensor ................................................................................................................. 76

15 Maintenance Intervals ..................................................................................................................... 77

16 Preparation / Cleaning / Disinfecting ............................................................................................. 78

17 Technical Data ................................................................................................................................... 80

Operating Manual fabian + nCPAP evolution 6 / 95

7 / 95 Operating manual fabian + nCPAP evolution

The table of contents will help you to find a topic quickly.

Operating Manual fabian + nCPAP evolution 8 / 95

Notes supplement the action instructions

9 / 95 Operating manual fabian + nCPAP evolution

3.1 Essential information

If the ventilator has a recognizable defect, as a result of which the life-preserving

The ventilator may not be used areas under risk of explosion!

Operating Manual fabian + nCPAP evolution 10 / 95

Disconnect the mains plug before opening the housing!

No antistatic or electrical conductive tubes may be used.

11 / 95 Operating manual fabian + nCPAP evolution

The device is a ventilator assigned to device We recommend ACUTRONIC Medical Systems

3.3 Liability for Function / Damage

ACUTRONIC Medical Systems AG does not

Operating Manual fabian + nCPAP evolution 12 / 95

 intermittent positive-pressure The device is operated by a doctor or under his

3.5 Scope of Delivery

13 / 95 Operating manual fabian + nCPAP evolution

In general, it should be noted with regard to contra-indications that ventilation of children

ACUTRONIC Medical Systems AG

Operating Manual fabian + nCPAP evolution 14 / 95

15 / 95 Operating manual fabian + nCPAP evolution

2 Connection for nCPAP system

3 Pressure measurement tube / prox.

Operating Manual fabian + nCPAP evolution 16 / 95

1 Mains connection with fuse holder

17 / 95 Operating manual fabian + nCPAP evolution

RS232, serial interface

Network connection RJ45

Connection for medicine nebulizer

Connection for external trigger

Caution, take note of important safety information and

Connection for potential equalization

Labelling according to Directive 93/42/EEC concerning

Manufacturer / date of manufacture

Application part type B

Operating Manual fabian + nCPAP evolution 18 / 95

Follow the operating manual