BionX BiOM T2 Ankle, Instructions For Use Manual

Page: 49 / 52

49
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Battery Charger is intended for use in the electromagnetic environment specified below. The customer
or the user of the Battery Charger should assure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance Level
Electromagnetic Environment -
Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3Vrms
150kHz to 80MHz
3 V/m
80MHz to 2.5GHz
3V
3V/m
Portable and mobile RF communications
equipment should be used no closer to
any part of the Battery Charger, including
cables, than the recommended separation
distance calculated from the equation ap-
plicable to the frequency of the transmitter.
Recommended separation distance:
d=1.2√P
d=1.2√P 80 MHz to 800 MHz
d=2.3√P 800 MHz to 2.5 GHz
Where P is the maximum output power rat-
ing of the transmitter in watts (W) accord-
ing to the transmitter manufacturer and d
is the recommended separation distance
in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey a should be less than the compli-
ance level in each frequency range b .
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorp-
tion and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be pre-
dicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF trans-
mitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the Battery Charger is used exceeds the applicable RF compliance level above,
the Battery Charger should be observed to verify normal operation. If abnormal performance is ob-
served, additional measures may be necessary, such as re-orienting or relocating the Battery Charger.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.