GE TruTrak+ 3900, Руководство пользователя

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7-1
7/Compliance and Specifications
This chapter contains
•
Information about the tests that were conducted and the regulations with
which the oximeter complies to assure its safe use.
•
Performance specifications for the oximeter.
Compliance with standards
The presence on the monitor of any symbol described below indicates
compliance with the standard represented by that symbol.
0537
Medical Device Directive 93/42/EEC of the European Union for a
class I (with a measuring function), IIa, IIb, or III device.
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.
General safety requirements
The 3900 and 3900P comply with the requirements of EN 60601-1 Part 1: General
requirements for safety of medical electrical equipment.
Type BF applied part.
Type of protection against electric shock: Class I/Internal electrical power source
Degree of protection against ingress of liquids: Ordinary (IPX0)
Mode of operation: Continuous
The monitor also complies with the following:
EN 865 Pulse oximeters – Particular requirements
EN 475 Medical devices – Electrically-generated alarm signals