Cutera ExcelV - Additional Safety Considerations; Electrical Hazard Precautions

64
EXCEL V OPERATOR MANUAL
D1025, REV H, 10/17
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 60825:2014
Type BF
Applied Part Handpiece
Eye Safety
Nominal Ocular Hazard Distance 1.45E+5 m at 532 nm
1.33E+5 m at 1064 nm
Minimum Optical Density for 5.89 at 532 nm
Protective Eyewear 5.81 at 1064 nm
Maximum Permissible Exposure 1.35E-4 W/cm
2
at 532 nm
4.02E-4 W/cm
2
at 1064 nm