Candela AlexTriVantage, Operator'S Manual

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D-2 Confidential 8501-00-1800, Revision 05
Candela Corporation AlexTriVantage Laser System
If interference from the AlexTriVantage Laser is suspected, ensure that the unit is plugged
into an AC Mains that is not shared by the affected equipment. If the interference still exists,
move the AlexTriVantage Laser or the affected equipment into another room.
Table D-1
lists the system specifications of the AlexTriVantage Laser System.
Regulatory Classifications
The laser is a Class 4 laser product with Class 3R aiming beam per EN60825-1 Laser Hazard
Classification. The Candela Laser System is a Class II medical device per FDA 21 CFR
878.4810, and a Class 2b (Rule 9), non-invasive, active device according to Annex IX of
Directive 93/42/EEC and Canadian Health Ministry Classification.
The AlexTriVantage complies with 21 CFR 1040.10 and 1040.11 except for deviations
pursuant to Laser Notice No. 50, dated July 26, 2001
Table D-1: Compliance per IEC/EN60601-1
Protection Specification
Type of protection against
electric shock Class 1 equipment
Degree of protection against
electric shock Type “B”
Sterilization method None required
Ingress Protection Ordinary enclosed
Not “AP” or “APG” equipment