Polymap Wireless Polytel GMA3, Руководство пользователя

Страница: 22 / 27

Polytel ® GMA3
11-2520-2 October 2017 22
The GMA is classifi ed as Class I Medical Devices per
21CFR, and under the IVDD directive for CE.
The various glucose meters are approved for use by their
manufacturer. Polymap Wireless is not responsible for
their diagnostic accuracy or their electrical safety.
4.3 Compliance Information
This section is about the telemetry system regulatory
compliance requirements and the manufacturer’s
responsibilities.
4.3.1 Compliance Requirements
Polymap Wireless is responsible for the effects of safety,
reliability, and performance of the GMA as long as:
•
You use the equipment according to the instructions in
this manual.
• All repairs, changes, assembly operations, and
extensions are done only by Polymap Wireless.
4.3.2 Compliance Statement
Polymap Wireless states that this device conforms with
the essential requirements of Council Directive 98/79/EC
on In Vitro Diagnostic Medical Devices, Council Directive
2104/53/EU on Radio Equipment Directive and Council
Directive 2011/65/EU on Restriction of the Use of Certain