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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 31/38
•
If cleaning in due form is insufficient, exchange the plasma source unit and use a new
plasma source unit.
Check the plasma care®, especially the plasma source unit and the plasma source for dam-
age such as cracks or fissures:
•
In case of damage, the plasma care® needs to be returned to the manufacturer for
servicing and repair.
Check the wired contacts between the plasma care® and the plasma source unit for corro-
sion:
•
In case of corrosion of the wired contacts between the plasma care® and the plasma
source unit the plasma care® needs to be returned to the manufacturer for servicing.
11
Environmental conditions
Start-up of the plasma care® after storage or transport must only take place if the operating
conditions are met:
11.1
Operating conditions
The plasma care® can be operated under regular lighting conditions at the work place.
The plasma care® can be used for inpatient as well as outpatient care.
The plasma care® and the spacer can be used at temperatures between
+10°C and +35°C.
The plasma care® and the spacer can be used at a relative humidity between
25% and 70% RH.
The plasma care® and the spacer can be used at atmospheric pressure be-
tween 800 hPa and 1060 hPa.
ID013
Before starting-up the plasma care® after it has been transported, the medical
device needs to reach a temperature within the operating conditions.
At 20°C the medical device needs at least 5 minutes to cool down from the
highest permissible storage or transport temperature to the highest admissible
operating temperature.
At 20°C the medical device needs at least 5 minutes to warm up from the low-
est permissible storage or transport temperature to the lowest admissible oper-
ating temperature.
11.2
Storage conditions
The plasma care® can be stored at temperatures b5°C and +45°C.
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