User Manual

Polytel
®
GMA2
9-2520-A September 2013 22
Polytel
®
GMA2
9-2520-A September 2013 23
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:
• FDA 21 CFR Parts 820
• EU/EN 61326-1
• EU/EN 300 328
• EU/EN 301 489
• The manufacturer of this device complied with
the following requirements applicable at time of
manufacture:
• ISO 13485:2003
• ISO 13485/8 under Canadian Medical Device
Conformity Assessment System (CMDCAS)
4.4 About the label at the bottom
of the GMA
The label on the side of your GMA shows the unique ID
number (serial number) of your device as well as some
other things you might need to know:
Seal/Mark Meaning
Device was tested to comply with
the CE EMC directive.
You should read accompanying
documents before use.
Device uses Bluetooth 2.1
IEC/UL/CAN/CSA
61010-1 61326-1
Device complies with both the
safety and the radio requirements
of these respective standards.
FCC:
QYPPWR0902
FCC listing number for the
device.
IC:
4552A-PWR0902
Industry Canada listing number
for the device
S/N:
0015B4010204
Unique serial number