Environment; Voluntary Standards - Integra CUSA Clarity System Service And Maintenance Manual

10.8 Environment

Moisture
Console Ingress Protection Rating
Operating
Temperature range
Humidity range
Atmospheric pressure range
Storage and Shipping
Temperature range
Humidity range
Note
Other devices in the operating room may generate electromagnetic interference. Use caution in locating equipment within the room to reduce the
electromagnetic interference.

10.9 Voluntary Standards

The CUSA Clarity system meets the following standards:
• IEC 60601-1:2005 +CORR. 1:2006 + CORR.2:2007 + AM1:2012 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and
Essential Performance, Third Edition Amendment 1
• ANSI/AAMI ES60601-1:2012 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance
• CSA C22.2 No. 60601-1:2012 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance
• IEC 60601-1-6:2010+AMD1:2013 Medical Electrical Equipment - Part 1-6: General requirements for basic safety and essential performance
- Collateral Standard: Usability
• IEC 60601-1-8:2006+AMD1:2012 Collateral Standard - General requirements for alarm systems in Medical Electrical Equipment
• EN 60601-1-2:2007 and IEC 60601-2:2007 (3
• IEC 60601-1-2:2014 (4
Statutory and Regulatory Classification
• Class II (FDA) Medical Device (General Controls and Special Controls)
• Class IIb (EU)
• Class III (EU)
• Class 4 (Canada)
CUSA® Clarity System Service and Maintenance Manual
10°C (50°F) to 35°C (95°F)
30 to 85%, relative humidity, non-condensing
70 kPa to 106 kPa (10.15 to 15.38 psi)
-20°C (-4°F) to 60°C (140°F)
15 to 85% relative humidity, non-condensing
edition) Collateral Standard Electromagnetic Compatibility Medical Electrical Equipment
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edition) Collateral Standard Electromagnetic Compatibility Medical Electrical Equipment
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IPX1
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