Revision 5.5
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14
Safety Check (SC)
NOTICE
Compliance of the laser surgery device with the safety requirements must be verified annually
by a technical safety check according to IEC 62353.
Technical safety checks may be performed only by service technicians authorized by
Gebrüder Martin.
Performance of the safety check must be entered into the medical product log, and the results
are to be documented!
Scope and intervals of the safety check
Frequency:
annually
Device:
MCO 25 plus
Device class (MDD):
IIb
Serial number:
Inv. number:
Operating hours:
Operator:
Location:
Tests as in IEC 62353, section 5.1 to 5.3
NOTICE
To avoid damaging the device, measuring the insulation resistance is not allowed
(IEC 62353, section 5.3.4).
1
Visual check
[ ] 1.1 Laser labels (laser class, max. output power, wavelength...)
[ ] 1.2 Information/warning labels; visible and complete on the device
[ ] 1.3 Instructions for use and medical product log available
[ ] 1.4 Mains cable in proper condition
[ ] 1.5 Accessory equipment complete
[ ] 1.6 Outer device surfaces OK
[ ] 1.7 Optical accessory has been checked
2
Functionality check
[ ] 2.1 Foot switch, key switch
[ ] 2.2 Beam guidance system/pilot laser
[ ] 2.3 Optical accessory, e.g. focusing handpiece
[ ] 2.4 Laser protection goggles
