Emc Precautions - TensCare mamatens my time Instructions For Use Manual

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20. EMC PRECAUTIONS

Use special precautions regarding EMC according to the information provided below. Other
portable and mobile RF communications equipment can affect performance. Do not use
when adjacent to or stacked with other electrical equipment. Use of leads or pads other
than those listed in section 18 may affect EMC performance.
Guidance and manufacturer's declaration – electromagnetic emissions
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.
Emissions test
Compliance
RF emissions CISPR 11
Group 1
RF emissions CISPR 11
Class B
Harmonic emissions IEC61000-3-2
Not applicable
Voltage fluctuations/flicker emissions
Not applicable
IEC 61000-3-3
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
Electrostatic discharge (ESD)
±6 kV contact
IEC 61000-4-2
±8 kV air
If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient /burst
±2 kV for power supply lines
IEC 61000-4-4
±1 kV for input/output lines
±1 kV differential
Surge mode IEC 61000-4-5
±2 kV common mode
Voltage dips, short
<5 % UT (>95 % dip in UT) for 0,5 cycle
interruptions and voltage
40 % UT (60 % dip in UT) for 5 cycles
variations on power supply
70 % UT (30 % dip in UT) for 25 cycles
input lines IEC 61000-4-11
<5 % UT (>95 % dip in UT) For 5s
Power frequency (50/60 Hz)
3 A/m
magnetic field. IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
35
Electromagnatic environment - guidance
The mamaTENS uses RF energy only for its
internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment
The mamaTENS is suitable for use in domestic
establishment and in establishment directly
connected to a low voltage power supply
network which supplies buildings used for
domestic purposes.
Electromagnetic
environment guidance
±6 kV contact
Floors should be wood,
±8 kV air
concrete or ceramic tile
Not applicable
Not applicable
Not applicable
Not applicable
Not applicable
Not applicable
Not applicable
Not applicable
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
Compliance
Electromagnetic environment – guidance
test level
level
Conducted RF
3 Vrms
3 Vrms
Portable and mobile RF communications equipment should be
IEC 61000-4-6
150 kHz to
used no closer to any part of the mamaTENS, including cables,
80 MHz
than the recommended separation distance calculated from
the equation applicable to the frequency of the transmitter
Radiated RF
3 V/m
3 V/m
661000-4-3
80 MHz to
Recommended separation distance 3V
2,5 GHz
d = 1.2√ P 80M Hz to 800MHz
d = 2.3√ P 800MHz 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 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 output power
Separation distance according to frequency of transmitter M
of transmitter W
150kHz to 80MHz
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 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.
80 MHz to 800 MHz
800MHz to 2.5GHz
d=1.2√ P
d=2.3√ P
0.12
0.23
0.38
0.73
1.2
2.3
3.8
7.3
12
23
36

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