
Polytel
®
GMA2
9-2520-3
October
2016
21
provisions of the EU IVD Directive 98/79/EC. It is also
a low power wireless device as defi ned in the EU Radio
Equipment Directive 2014/53/EU
The various glucose meters are approved separately
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 to:
•
Radio Equipment Directive 2014/53/EU