User's Manual

Page 69 of 72
1000001386A
11.6. Table 6: Guidance and Manufacturer’s Declaration – Electromagnetic
Immunity
The Biosensor is tested for conformance to meet the following intended for use in
the electromagnetic environment specified below. The customer or the user of the
Biosensor should assure that it is used in such an environment.
Immunity test
Compliance Level test level
Electrostatic discharge (ESD) as per
IEC 61000-4-2
± 8 kV contact
± 15 kV air
Power frequency magnetic field as
per IEC 61000-4-8
30 A/m
Radiated RF as per IEC 61000-4-3
10 V/m
80 MHz - 2.7
GHz
80% AM at 1
KHz
The Biosensor is also tested for immunity to proximity to wireless communication
equipment as per Table 9 of IEC 60601-1-2 using the test methods specified in
IEC 61000-4-3
11.7. Table 7: FCC Statement
This device complies with Part 15 of the FCC rules. Operation is subject to the
following conditions:
1. This device may not cause harmful interference.
2. This device must accept any interference received including interference
that may cause undesired operation of this device.
Any changes or modifications not expressly approved by the party responsible
for Compliance could void the user’s authority to operate the equipment.
Biosensor radiator (Antenna) is at 8.6mm away from the body and hence,
exempted from SAR measurement. Please affix Biosensor on body as instructed
in this manual for maintaining the separation distance