Instructions for Use / Technical Description
Ultrasonic Unit SonicWeld Rx
11
Safety Checks (SC)
NOTICE
All safety checks must be documented in the medical device logbook together with the
inspection and test results!
Once a year a safety check must be carried out acc. to IEC 62353 in order to verify that the
unit duly conforms to safety regulations. The results of each check must be documented and
the proper working condition of the unit confirmed by the person performing the check.
For frequency and scope of the safety check, see IEC 62353.
The points listed here are additional check points.
Frequency:
Device class (MDD):
Inv. number:
V. 1.0
®
annually
IIb
Device:
Serial number:
Operating hours:
®
SonicWeld Rx
75