3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use
Page 23
Section 20 Alarm and Advisory Messages
The essential performance of the device consists of proper delivery of appropriate FiO
2
based on
patient clinical need as reflected in their SpO
2
reading. The User needs to appropriately respond to
alarms to ensure the essential performance of the device is maintained.
The Oxygen Assist Module does not provide SpO
2
alarms. Separate and independent patient
monitoring must be used.
The alarm condition delay is the time between the patient event and to when the Oxygen Assist
Module detects the issue. The alarm signal generation delay is the time between when the
Oxygen Assist Module detects the issue and when the Alarm is generated. The maximum delay is
approximately 1 second.
The below Alarm and Advisory Messages will be displayed when a Case is Active and when the
Oxygen Assist Module is in Auto Mode. Fallback %O
2
will be delivered when SpO
2
signal is missing.
Medium Priority Alarm Message
Action and Troubleshooting
Battery Low - Shutdown Imminent
Plug Oxygen Assist Module into external power
Check SpO
2
- Adhesive Sensor Expired
Replace sensor, enter MANUAL Mode, or End Case
Check SpO
2
- Defective Adhesive Sensor
Replace sensor, enter MANUAL Mode, or End Case
Check SpO
2
- Defective Cable
Replace cable, enter MANUAL Mode, or End Case
Check SpO
2
- Defective Sensor
Replace sensor, enter MANUAL Mode, or End Case
Check SpO
2
- Incompatible Adhesive Sensor
Replace sensor, enter MANUAL Mode, or End Case
Check SpO
2
- Incompatible Cable
Replace cable, enter MANUAL Mode, or End Case
Check SpO
2
- Incompatible Sensor
Replace sensor, enter MANUAL Mode, or End Case
Check SpO
2
- No Adhesive Sensor Connected
Reconnect sensor with good signal, enter MANUAL Mode, or
End Case
Check SpO
2
- No Cable Connected
Reconnect cable with good signal, enter MANUAL Mode, or
End Case
Check SpO
2
- No Sensor Connected
Reconnect sensor with good signal, enter MANUAL Mode, or
End Case
Check SpO
2
- Sensor Expired
Replace sensor, enter MANUAL Mode, or End Case
Check SpO
2
- Unrecognized Adhesive Sensor
Replace sensor, enter MANUAL Mode, or End Case
Check SpO
2
- Unrecognized Cable
Replace cable, enter MANUAL Mode, or End Case
Check SpO
2
- Unrecognized Sensor
Replace sensor, enter MANUAL Mode, or End Case
Insert Time Card or End Case
Time Card expired or removed. Insert Time Card or End Case
Precision Flow Communication Error
Restore Precision Flow Connection, enter MANUAL Mode, or
End Case
Precision Flow Invalid Software Version
Restore Precision Flow Connection, or End Case and Update
Precision Flow Software
SpO
2
Communication Error
Alert self-corrects, enter MANUAL Mode, or End Case
System Reset - Check Settings
Check settings. Press any key, touch screen or turn settings
control knob
