GE TuffSat, Руководство пользователя и сервисное руководство

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4-1
4. 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
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 oximeter complies 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: Internally powered equipment
Degree of protection against ingress of liquids (EN 60529): Ordinary (IPX0)
Mode of operation without exceeding temperature limits: Continuous
The oximeter also complies with the following (as they apply to a device that has no
alarms and is not intended for continuous monitoring):
EN 60601-1-1 Medical Electrical Equipment; Part 1: General requirements for
safety – 1. Collateral standard: Safety requirements for medical
electrical systems
EN 865 Pulse oximeters – Particular requirements