Össur i-limb access hand, Instructions For Use Manual

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15 14
Guidance and manufacturer’s declaration – electromagnetic immunity
Össur Myoelectric Prosthetic Devices are intended for use in the electromagnetic environment specified below.
The customers or the users of Össur Myoelectric Prosthetic Devices should assure that each are used in such an
environment.
Immunity test IEC 60601
test level Compliance level Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6 Not applicable Not applicable
Battery Powered
No Cables >3 m
Portable and mobile RF communications
equipment should be used no closer to
any part of the Össur Myoelectric
Prosthetic Devices including cables, than
the recommended separation distance
calculated from the equation appropriate
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
rating of the transmitter in watts (W)
according 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 compliance level in each
frequency range
b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Radiated RF IEC
61000-4-3 3 V/m
80 MHz to
2.5 GHz 3 V/m
80 MHz to
2700 MHz
1kHz 80% AM
Upper frequency
extended to
2700 MHz)
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 absorption
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 predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the Össur Myoelectric
Prosthetic Devices are used exceeds the applicable RF compliance level above, Össur Myoelectric Prosthetic
Devices should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re- orienting or relocating the Össur
Myoelectric Prosthetic Devices