VQ OrthoCare BioniCare Manual De Instrucciones página 31

Guidance and manufacturer's declaration - electromagnetic immunity
IEC 60601
Immunity test
Test Level
Conducted RF 3 Vrms
IEC6100-4-6 150KHz to
80MHz
Radiated RF 3 V/m
IEC 610004-3 80MHz to
Radiated RF 2.5GHz
IEC 61000-4-3
(continued)
Note: At 80MHz and 800 MHz, the higher frequency range applies.
Note: 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 BioniCare Knee System
is used exceeds the applicable RF compliance level above, the BioniCare Knee System should
be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the BioniCare Knee System.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
BioniCare
Compliance
Electromagnetic environment - guidance
level
Recommended Separation Distance
3 Vrms
3 V/m
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
surveya, should be less than the compliance
level in each frequency range b.
Interference may occur in the vicinity of
the equipment marked with the following
symbol:
(IEC 60417 No. 417-IEC-5140: "Source of
non-ionizing radiation")
Knee System
®
d = 1.2 √P
d = 1.2√P
80 MHz to 800MHz
d = 2.3√P
800 MHz to 2.5GHz
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