Laser Surgical Unit diomax
®
Revision 6
69
12
Safety Check (SC)
NOTICE
Safety checks may be performed only by Gebrüder Martin or by authorized Gebrüder Martin
service partners.
Performance of the safety check must be entered into the medical product log, and the results
are to be documented!
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 in the
medical device logbook, and the proper working condition of the unit confirmed, by the person
performing the check.
The scope and intervals of the safety checks are described in IEC 62353. The items
listed here are additional test items.
Intervals:
annually
Device:
diomax
®
Device class (MPG):
IIb
Serial no.:
Inv. no.:
Operating hours:
Operator:
Location:
See IEC 62353, Sections 5.1
–
5.3, for tests
NOTICE
For avoidance of damage to the device, measuring the insulation resistance is not allowed
(IEC 62353, section 5.3.4).
