fabian HFO Overview and Comparison sw verl 5.1.x

Ventilation Beyond Limits

Software v5.1.x applicability Software v5.1.x is valid for each fabian HFO configuration:

fabian HFO ventilators with blue or white housing with and without HFO module Serial number prefix: 20 / AH / AK / AI / AL

Ventilation Beyond Limits

FSCA 18-004 coverage Issue

Fix

A Graphical User Interface (GUI) freeze/crash could occur when the device is connected to an Ethernet network. It could also cause loss of ventilation with alarming during patient use. In case of an error in our device’s alarm system, there may be no or no sufficient notification to the user of an alarming condition.

RJ45 port blocker inserted into the Ethernet port and disabled Ethernet communication possibilities in the software A warning had been added to the IFU. IFU WARNING: Only use this ventilator in combination with an external monitoring device (for example: SpO2). Software reviewed. Alarm is triggered.

While using volume guarantee option, a disconnection of the patient circuit may not generate a patient disconnect alarm. When saving, loading or manipulating trends a system failure or application error could occur causing loss of ventilation with alarming. Switching between languages could result in a GUI freeze/crash causing loss of ventilation with alarming. In SIMV breath delivery while using volume limit mode, the ventilator may deliver incorrect ventilation skipping expected mandatory breaths. Pressure might not be immediately released when high peak inspiratory pressure (PIP) alarm is triggered (when high PIP alarms are set less than 12 mbar above the set PIP) as pressure release is not tied to it. Pressure relief occurs 12 mbar above the set PIP and pressure is released till ZEEP. User bypass of the flow sensor and O2 sensor calibration could result in incorrect ventilation.

In dual limb CPAP ventilation, the ventilator may deliver a lower number of burst breaths than what is set.

Software reviewed. Improved trend handling. It does not cause application error. Software reviewed. Improved language handling. Changing languages no longer results in a GUI freeze/crash. Software reviewed. SIMV+VL delivers correct number of mandatory breaths. Introduce a new breath termination functionality at PIP_high alarm limit level. Furthermore, a description was added in the IFU for the pressure release behaviours. Software workflow improved. Alarms are activated in case of using uncalibrated sensors. Software reviewed. Correct number of burst breaths are delivered.

Ventilation Beyond Limits

fabian HFO software changes 1.

Flow sensor calibration reminders

2.

Disabled Ethernet port

3.

Alarm tone confirmation

4.

Pause/Standby confirmation

5.

Power off confirmation

6.

Oxygen sensor

7.

NIV flow compensation levels

8.

Breath termination functionality

9.

Emergency shutdown

10.

New licenses and demo option

11.

PRICO (Predictive Intelligent Control of Oxygenation)

12.

Forced Oscillation Technique

13.

Synchronised DUOPAP mode

14.

NCPAP with breath detection

15.

InfantFlow and InfantFlow LP flow sensor connection

16.

Breath detection based on pressure at CPAP

17.

Pressure trigger option at conventional modes

18.

New alarm limit settings

19.

E-flow = I-flow option

20.

O2 flush setting

21.

VTe BW [ml/kg] numeric field

22.

Revised Volume Guarantee

23.

PSV mode

24.

Updated numeric configurations

25.

New pressure parameter dependencies

26.

New item in ventilation setting

27.

Updated numeric measurements

28.

Flow and tidal volume measurement reset

29.

Displayed unavailable functions

30.

NCPAP and DUOPAP only in NEO mode

31.

Loop drawing change

32.

New trend parameters

33.

Trend file update

34.

Service maintenance reminder

35.

New acuLink version

Ventilation Beyond Limits

1. Flow sensor calibration reminders Change: Alarms related to flow sensor calibration are triggered in more cases than before: • After device startup • After enabling the flow sensor (manual and automatic) • After patient range change • After reconnection of a flow sensor resolving a disconnection alarm

Ventilation Beyond Limits

2. Disabled Ethernet port Change: Ethernet communication is not suitable for this software version. The Ethernet port is physically blocked with a plastic port blocker (RJ45). Besides, the PDMS (Patient Data Management System) related Ethernet software options are no longer available.

Ventilation Beyond Limits

3. Alarm tone confirmation Change: As part of the system start up procedure, it is required to perform a new audio alarm test and confirm the audible alarm was heard.

Ventilation Beyond Limits

4. Pause/Standby confirmation Change: A new popup window is now activated after the start/stop button is pressed, to confirm or reject the activation of ventilation standby/pause.

Ventilation Beyond Limits

5. Power off confirmation Change: A new popup window is activated after the on/off button is pressed, to confirm or reject device shutdown.

Ventilation Beyond Limits

6. Oxygen sensor Change: “O2 sensor calibration failed”, “Oxygen sensor defect” and “Oxygen sensor used up” alarms can be now terminated by the following actions: • Disabling the O2 sensor • Performing an O2 calibration (successful) The software now automatically performs an O2 sensor calibration when the O2 sensor is activated.

Ventilation Beyond Limits

7. NIV flow compensation levels SW 5.1

Change: Four level of leak compensation is available. Off, low, middle and high: 0%, ≤~10%, ≤ ~20%, ≤ ~30%. The setting is accessible in the quick setting too.

Ventilation Beyond Limits

8. Breath termination functionality Change: When the measured pressure reaches or goes beyond PIPhigh alarm limit level while being in inspiratory phase, the software now automatically terminates the inspiratory phase and switches to expiratory phase, decreasing the pressure to the set PEEP level in the circuit and then continues to ventilate.

Ventilation Beyond Limits

9. Emergency shutdown Change: In case the device becomes inoperable it can be switched off by applying the following sequence: 1. Keep on/off button pushed for 1-2 seconds 2. Release on/off button for 1-5 seconds 3. Keep on/off button pushed for at least 5 seconds

Ventilation Beyond Limits

10. New licenses and demo option

Change: Three new major functionalities became available: FOT, PRICO and NIV trigger. Also there is a possibility to ask for a demo license for any modules with a validity period of 90 days. The remaining number of days are displayed under Service Mode/Licensing. The license codes can be still exported under Tools/Device Info.

Ventilation Beyond Limits

11. PRICO (Predictive Intelligent Control of Oxygenation)*

Change: Automatic control of oxygenation is available in each ventilation mode. *license dependent

Ventilation Beyond Limits

12. Forced Oscillation Technique*

Change: Forced Oscillation Technique is available under Waves/Loops menu at every invasive ventilation modes. For further information please refer to the FOT supplement. *license dependent

Ventilation Beyond Limits

13. Synchronised DUOPAP mode* SW 3.3

SW 5.1

Change: At DUOPAP mode pressure trigger is available with MediJet generator and flow trigger with InfantFlow and InfantFlow LP generators. Once the trigger sensitivity is turned off there is no supported breath. *license dependent

Ventilation Beyond Limits

14. NCPAP with breath detection* SW 3.3

SW 5.1

Change: Depending on the selected generator breath detection is available based on flow (InfantFlow and InfantFlow LP) and pressure measurements (MediJet). *license dependent

Ventilation Beyond Limits

15. InfantFlow and InfantFlow LP flow sensor connection

In order to use InfantFlow and InfantFlow LP generators with the fabian’s new breath detection functionality one must connect flow sensor at the end of the exhalation tube. Depending on the generator an interconnecting element might be necessary.

Ventilation Beyond Limits

16. Breath detection based on pressure at CPAP SW 3.3

SW 5.1

Change: When flow sensor is turned off, breath detection and backup breaths are still available based on pressure measurement at CPAP mode.