PROTEUS XR/a
GE MEDICAL SYSTEMS Operator Manual
REV 11 DIRECTION 2259724-100
iii
REGULATORY REQUIREMENTS
This product complies with the regulatory requirements of the
following:
• Council Directive 93/42/EEC concerning medical devices: the CE label affixed to the
product testifies compliance to the Directive.
The location of the CE label on the product is described page 2-4.
European registered place of business:
GE Medical System Europe
Quality Assurance and Safety Regulatory Manager
BP 34
F 78533 BUC CEDEX FRANCED
Tel: +33 (0) 1 30 70 40 40
• Green QSD 1990 Standard issued by MDD (Medical Devices Directorate, Department
of Health, UK).
• Quality System Regulation issued by the FDA (Food and Drug Administration,
Department of Health, USA).
• Underwriter’s Laboratories, Inc. (UL), an independent testing laboratory.
• Canadian Standards Association (CSA).
• International Electrotechnical Commission (IEC).
The following equipment classifications are applicable to the
product:
• Equipment classification with respect to protection from electric shock: Class 1
• Degree of protection from electric shock: Type B
• Degree of protection against ingress of liquids: not classified
• Equipment not suitable for use in the presence of a flammable anaesthetic mixture with
air or with nitrous oxide; mode of operation: continuous
• Mode of operation: continuous with intermittant loading
• The Proteus XRa has only level 1 EMC susceptability immunity responses.
FOR TRAINING PURPOSES ONLY!
NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
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