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Gendex DenOptix QST - Electrical Requirements; Compliance to Standards

Gendex DenOptix QST
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Pre-Installation Information and Recommendations
032-0265-EN Rev 1 3-11
Electrical Requirements
Compliance to Standards
Voltage 100-240 V AC 50/60 Hz power supply auto-senses the input voltage.
Power 110 watts maximum
Power Cord Standard line cord provided (Medical Grade for 115V)
Standard Title
UL 60601-1 Medical Electrical Equipment, Part 1: General
requirements for safety
21 CFR Chapter I Subchapter J Performance Standard for Light-Emitting Products
MDD 93/42/ECC European Medical Device Directive (CE Mark)
CAN/CSA-C22.2 No. 601.1 Medical Electrical Equipment, Part 1: General
requirements for safety
IEC 60601-1 Medical Electrical Equipment, Part 1: General
requirements for safety
IEC 60601-1-2 Medical Electrical Equipment, Part 1: General
requirements for safety- Collateral standard;
Electromagnetic Compatibility
IEC 60825-1 Safety of Laser Products
ISO 13485 Medical devices- Quality management systems
ISO 14971 Risk Analysis

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