Integra CUSA Clarity System - Environment; Voluntary Standards

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CUSA® Clarity System Service and Maintenance Manual Page 91 of 117 0645403-2-EN
Note
Other devices in the operating room may generate electromagnetic interference. Use caution in locating equipment within the room to reduce the
electromagnetic interference.
Operating
Temperature range 10°C (50°F) to 35°C (95°F)
Humidity range 30 to 85%, relative humidity, non-condensing
Atmospheric pressure range 70 kPa to 106 kPa (10.15 to 15.38 psi)
Moisture
Console Ingress Protection Rating
IPX1
Storage and Shipping
Temperature range -20°C (-4°F) to 60°C (140°F)
Humidity range 15 to 85% relative humidity, non-condensing
10.8 Environment
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
rd
edition) Collateral Standard Electromagnetic Compatibility Medical Electrical Equipment
• IEC 60601-1-2:2014 (4
th
edition) Collateral Standard Electromagnetic Compatibility Medical Electrical Equipment
Statutory and Regulatory Classification
• Class II (FDA) Medical Device (General Controls and Special Controls)
• Class IIb (EU)
• Class III (EU)
• Class 4 (Canada)