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Table 4 – Immunity Test Level Compliance
The BIOFLEX
Personal Therapy System is intended for use in the electromagnetic
®
environment specified below. The customer or the user of the BIOFLEX
System should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test
Compliance
Level
Level
3 Vrms 150 kHz
3 Vrms 150 kHz
to 80 MHz
to 80 MHz
6 Vrms ISM/
6 Vrms ISM/
Amateur Radio
Amateur Radio
bands inside
bands inside
Conducted RF
150 kHz to 80
150 kHz to 80
IEC 61000-4-6
MHz
Radiated RF
3 V/m 80 MHz
3 V/m 80 MHz
IEC 61000-4-3
to 2,7 GHz
to 2,7 GHz
RF
communication
communication
equipment
equipment
inside 80 MHz
inside 80 MHz
to 6 GHz
to 6 GHz
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/cord-
less) 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 BIOFLEX® Personal Therapy System is used exceeds the applicable RF compliance
level above, the BIOFLEX® Personal Therapy 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 BIOFLEX® Personal Therapy System
b.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3
V/m.
40
MN 421.012 Rev 3
Personal Therapy
®
Electromagnetic
Environment – Guidance
Portable and mobile RF com-
munications equipment should
be used no closer to any part of
the BIOFLEX
Personal Therapy
®
System including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation
distance
d=1.2√P
MHz
d=1.2√P 80 MHz to 800 MHz
d=1.2√P 80 MHz to 2.7 GHz
where P is the maximum output
RF
power rating of the transmitter in
watts (W) according to the trans-
mitter manufacturer and d is the
recommended separation distance
in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site
survey
should be less than the
a
compliance level in each frequency
range
b
"WARNING: Portable RF communications equipment (including
peripherals such as antenna cables and external antennas) should be
used no closer than 30 cm (12 inches) to any part of the [ME Equipment
or ME System], including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result."
Table 5 – Recommended Separation Distances
Recommended separation distances between
portable and mobile RF communications equipment and the
BIOFLEX
Personal Therapy System
®
The BIOFLEX
Personal Therapy System is intended for use in an electromagnetic
®
environment in which radiated RF disturbances are controlled. The customer or the user
of the BIOFLEX
Personal Therapy System can help prevent electromagnetic interference
®
by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the BIOFLEX
below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum
output power of
transmitter
150 kHz to 80MHz
W
d=1.2√P
0.01
0.12
0.1
0.38
1
1.2
10
3.8
100
12
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be estimated using the equation applicable to
the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1
At 80 MHz and 800 MHz, the separation distance for 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.
Personal Therapy System as recommended
®
m
80 MHz to 800MHz
800 MHz to 2.7GHz
d=1.2√P
d=1.2√P
0.12
0.24
0.38
0.73
1.2
2.3
3.8
7.3
12
23
MN 421.012 Rev 3
41
