Compliance And Specifications; Compliance - GE TruSat User Manual

4. COMPLIANCE AND SPECIFICATIONS

Compliance

This chapter contains:
•
Medical electrical equipment standards and compliance information for the monitor.
•
Specifications.
European Union Medical Device Directive 93/42/EEC: Class IIb
EN 60601-1 Medical electrical equipment – Part 1: General requirements for safety
(including Amendments 1 and 2)
•
Type of protection against electric shock: Class I equipment/Internal electrical power
source
•
Degree of protection against electric shock: Defibrillation-proof type BF applied part
•
Degree of protection against ingress of water (EN 60529): IPX2
•
Not suitable for use in the presence of flammable anesthetic mixtures
•
Mode of operation: Continuous
nd
EN 60601-1-2 (2 Edition) Electromagnetic compatibility – Requirements and tests
CISPR 11/EN 55011 (Protection against emissions): Group I, Class B
IEC 60601-1-8 Alarm systems – General requirements, tests and guidance for alarm
systems in medical electrical equipment and systems
Medical electrical equipment classified in the US and Canada with respect to
electric shock, fire, and mechanical hazards only, in accordance with the
Canadian Standards Association CAN/CSA C22.2 No. 601.1 and Underwriters
Laboratories Inc. UL 2601–1.
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