Iridex PASCAL Synthesis - Page 108

PASCAL
®
Synthesis Ophthalmic Scanning Laser Systems Page 108 of 141
88292-EN, Rev D
Electrical Requirements
PASCAL Synthesis
(532 nm)
PASCAL Synthesis
(577 nm)
Voltage
100-240V~, 50/60Hz
Rated power
200VA
Fusing
200VA T2AH 250V
Fan noise
< 55 dBA
Product Classifications per IEC 60601-1
Class I equipment
Type B equipment
Standard equipment, Footswitch is IPX1
Non-sterile product
Equipment not suitable for use in the presence of a flammable anesthetic mixture with
air or with oxygen or nitrous oxide
Continuous operation
Classifications & Approvals
EN/IEC 60601-2-22
Laser Safety Requirements for Diagnostic and Therapeutic
Laser Equipment
EN/IEC 60601-1
International Safety Requirements for Medical Electrical
Equipment
EN/IEC 60601-1-2
EMC Requirements for Medical Electrical Equipment
ISO 14971
Risk Management for Medical Devices
CAN/CSA-C22.2 No.
60601-1
Canadian deviations for Medical Electrical Equipment
ANSI/AAMI ES 60601-1
US Safety Requirements for Medical Electrical Equipment
EN/IEC 60825-1
Safety of laser products
FCC
Tested and Complies With FCC Part 15 Class B