Use Instructions

Instruction for Use
plasma care and plasma care spacer
IFU plasma care© and plasma care© spacer
Version: 0.1
Date: 26.05.2020
Copyright: terraplasma medical GmbH
Page 12/38
2.3.5 Unexpected events
ID041
When you observe discomfort or an abnormal reaction in a patient, the treat-
ment needs to be stopped immediately. If the adverse event is serious, this needs
to be reported to the manufacturer and the responsible authority of the member
state, in which user and/or patient live, immediately.
ID042
When you notice that the environmental conditions change and that the
plasma care® is used outside of its operating requirements and specifications,
the treatment needs to be stopped.
2.3.6 Performance characteristics
The following performance characteristics might be limited if the device is operated in pres-
ence of electromagnetic disturbances:
• The plasma source produces the required cold atmospheric plasma
• A malfunctioning plasma source is recognized via the monitoring system
• The duration of treatment does not exceed the specified time
• The terraplasma spacer can only be used once
• The internal power supply supplies the device with the required voltage and fre-
quency