Safety Check (Sc) - KLS Martin group Laser Surgical Unit diomax 1550 Instructions For Use Manual

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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!
Compliance of the laser unit with the safety requirements must be checked annually by a
safety check. The proper working condition of the device shall be confirmed in the medical
product log by the inspector after every check.
The scope and intervals of the safety checks are described in IEC 62353. The items
listed here are additional test items.
Intervals:
Device class (MPG):
Inv. no.:
Operator:
See IEC 62353, Sections 5.1
NOTICE
For avoidance of damage to the device, measuring the insulation resistance is not allowed
(IEC 62353, section 5.3.4).
See IEC 62353, Sections 5.4, for functional tests
[ ] Control of calibration with an external power meter
(allowed tolerance ± 20%):
1 W/5 W/10 W/15 W
68
annually
IIb
5.3, for tests
–
Laser Surgical Unit diomax
Device:
Serial no.:
Operating hours:
Location:
Instructions for Use
®
®
diomax 1550
Revision 2
1550