cefar Direct TENS - Page 29

29
Direct TENS
™
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The Direct TENS™ Electrotherapy System is intended for use in the electromagnetic environment deified below. The
customer or the user of the Direct TENS™ Electrotherapy System should assure that it is used in such an environment.
Immunity
Test
IEC 60601
Test Level
Compliance Level Electromagnetic Environment - Guidance
Portable and mobile RF communications equipment should be
used no closer to any part of the Direct TENS™ Electrotherapy
System, including cables, than the recommended separation
distance calculated from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
Conducted
RF
IEC 61000-
4-6
3 Vrms
150 kHz to
80 MHz
[V
1
] V, where V
1
= 3V
d =
[
3,5
]
√P
V
1
Radiated RF
IEC 61000-
4-3
3 V/m
80 MHz to
2,5 GHz
[E
1
] V/m, where E
1
= 3V/m
d =
[
3,5
]
√P 80 MHz to 800 MHz
E
1
d =
[
7
]
√P 800 MHz to 2,5 GHz
E
1
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 metres (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:
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 aected 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 Direct TENS™ Electrotherapy
System is used exceeds the applicable RF compliance level above, the Direct TENS™ Electrotherapy System should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as reorienting or relocating the Direct TENS™ Electrotherapy System .
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V
1
] V/m.