Electrical Requirements; Compliance To Standards - Gendex DenOptix QST User Manual

Electrical Requirements

Voltage
Power
Power Cord

Compliance to Standards

Standard
UL 60601-1
21 CFR Chapter I Subchapter J
MDD 93/42/ECC
CAN/CSA-C22.2 No. 601.1
IEC 60601-1
IEC 60601-1-2
IEC 60825-1
ISO 13485
ISO 14971
032-0265-EN Rev 1
100-240 V AC 50/60 Hz power supply auto-senses the input voltage.
110 watts maximum
Standard line cord provided (Medical Grade for 115V)
Title
Medical Electrical Equipment, Part 1: General
requirements for safety
Performance Standard for Light-Emitting Products
European Medical Device Directive (CE Mark)
Medical Electrical Equipment, Part 1: General
requirements for safety
Medical Electrical Equipment, Part 1: General
requirements for safety
Medical Electrical Equipment, Part 1: General
requirements for safety- Collateral standard;
Electromagnetic Compatibility
Safety of Laser Products
Medical devices- Quality management systems
Risk Analysis
Pre-Installation Information and Recommendations
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