25
26
The mamaTENS is intended for use in the electromagnetic environment specified
below. The customer or the user of the mamaTENS 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 mamaTENS, including
cables, than the recommended separation distance
calculated from the equation applicable to the frequency
of the transmitter
Recommended separation distance 3V
d = 1.2
√
P 80M Hz to 800MHz
Conducted RF
3 Vrms
3 Vrms
d = 2.3
√
P 800MHz to 2.5GHz
IEC 61000-4-6
150 kHz to 80 MHz
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).
Radiated RF
3 V/m
3 V/m
Field strengths from fixed RF transmitters, as determined
61000-4-3
80 MHz to 2,5 GHz
by an electromagnetic site survey, should be less than
the compliance level in each frequency range.
Interference may occur in the vicinity of equipment
marked with the symbol on the left of this box
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 mamaTENS is used exceeds the applicable RF compliance level
above, the mamaTENS should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the mamaTENS.
b.Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF
communications equipment and the mamaTENS.
The mamaTENS is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the mamaTENS can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the mamaTENS as recommended below, according to
the maximum output power of the communications equipment.
Rated maximum
Separation distance according to frequency of transmitter M
output power of
150kHz to 80MHz
80 MHz to 800 MHz
800MHz to 2.5GHz
transmitter W
d=1.2
√
P
d=1.2
√
P
d=2.3
√
P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (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.
EC Declaration of Conformity
TensCare Ltd hereby declare that an examination of the production quality
assurance system has been carried out following the requirements of the
UK national legislation according to Annex V of the Directive 93/42/EEC
on medical devices. We certify that the production quality system conforms
with the relevant provisions of the aforementioned legislation, and the
result entitles the organization to use the CE 0
088
marking on this product.
mama tens instructions artwork.indd 30-31
