VQ OrthoCare BioniCare Manual De Instructiones página 24

BioniCare
EMC Compliance Table (cont.)
Guidance and manufacturer's declaration - electromagnetic immunity
IEC 60601
Immunity test
Test Level
Conducted RF
IEC6100-4-6 150KHz to
80MHz
Radiated RF
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.
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.
22
® Hand System
Compliance
level
3 Vrms 3 Vrms
3 V/m 3 V/m
Electromagnetic environment - guidance
Recommended Separation Distance
d = 1.2 √P
d = 1.2√P
80 MHz to 800MHz
d = 2.3√P
800 MHz to 2.5GHz
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")
If abnormal performance is