Classification

This equipment is listed with a nationally recognized testing laboratory and classified with respect to electric shock, fire, and mechanical hazards in accordance with the following standards:

•EN 60601-1 (1990), Medical Electrical Equipment, Part 1: General Requirements for Safety +A1(1993) +A2(1995) +A13(1996)

•UL 60601-1 (1st edition, 2006-04-26), Medical Electrical Equipment, Part 1: General Requirements for Safety

•IEC 60601-1 (2nd edition), Medical Electrical Equipment, Part 1: General Requirements for Safety, with A1 and A2

•CAN/CSA C22.2 No. 601.1-M90 (R2005), Medical Electrical Equipment, Part 1: General Requirements for Safety

•IEC 60601-1-4 (2000-2004), Edition 1.1 Consolidated Edition, Medical Electrical Equipment, Parts 1-4: General Requirements for Safety – Collateral Standard: Programmable Electrical Medical Systems

This equipment is classified as:

•Class I

•Type BF

•IPX2

•Continuous operation at temperatures of 95°F (35°C) down to 41°F (5°C), and short-time operation for 25 minutes at temperatures up to 104°F (40°C) and­93% ± 2% relative humidity.

DL-00096 Rev. 7

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