fabian HFO sw 5.1.x Release Overview and comparison to sw 5.0.x April 2019

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

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.

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. DUO level compensation 9. Breath termination functionality 10. Emergency shutdown

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

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.

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.

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.

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

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.

7. NIV flow compensation levels Change: OFF option has been added and the other compensation levels have been decreased from up to 15%, 30% and 40% to up to 10%, 20% and 30% respectively. SW 5.0.x

SW 5.1.x

8. DUO level leak compensation Change: Flow_DUO is set back to be dependent on baseline leak compensation setting as it used to be before software v5.0. Also in NCPAP/duoPAP mode the maximal flow has been limited to 20 LPM (decreased from 25 LPM). SW 5.0.x Flow_CPAP CPAP related base flow + measured leak related compensation with a maximum in accordance with the leak compensation setting Flow_DUO

SW 5.1.x CPAP related base flow + measured leak related compensation with a maximum in accordance with the leak compensation setting

P_DUO related base flow and measured leak P_DUO related base flow and measured leak related compensation with a maximum of 25 lpm related compensation with a maximum in accordance with the leak compensation setting but not more than 20 lpm

9. 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.

10. 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

Thank you!