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 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 II
• 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) and 93% ± 2% relative humidity.
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DL-00096 Rev. 8
