Cutera GenesisPlus - Electrical Requirements; Environmental Requirements; Classifications; Eye Safety

42
GenesisPlus Operator Manual
D1151, R
EV C, 10/16
Electrical Requirements
Voltage, Current (U.S.) 110 - 120 VAC/20A
220 - 240 VAC/20A
(International) 200 - 240 VAC/16A
Frequency 50/60 Hz
Environmental Requirements
Temperature Operating 5º C - 30º C (41º F - 86º F)
Storage -10º C - 50º C (14º F - 122º F),
coolant drained
Humidity 0 to 90%, non-condensing
Max. Heat Dissipation 4,000 Watts
Max. Altitude Operating 4,572 m (15,000 ft)
Non-operating 15,240 m (50,000 ft)
Classifications
FDA Classification Class II Medical Device
CDRH Classification Class IV Laser Product
European MDD 93/42/EEC
Laser Classification Class 4 Laser to IEC 60825:2007
Eye Safety
Nominal Ocular Hazard Distance 81 m at 1064 nm
Minimum Optical Density for Protective Eyewear ≥6.1 at 1064 nm
Maximum Permissible Exposure 2.69* 10
-4
W/cm
2
at 1064 nm
GenesisPlus is designed to comply with the following:
• US Federal Performance Standards 21 CFR 1040.10 and 1040.11 for Class IV Laser
Products and IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-22, IEC
60825.
• European Communities Medical Devices Directive 93/42/EEC.