Mazet Sante Biostim 2.2 User Manual page 39

EMC compliance according to IEC 60601-1-2 (2014) 4th Edition (EN 60601-1-2 : 2015)
The BIOSTIM is intended to be used in the electromagnetic environment specified below. The customer or user of BIOSTIM
should ensure that it is used in such an environment.
Test level IEC
IMMUNITY test
60601-1-2
3 Vrms
Conducted RF
disturbances
150 kHz to 80 MHz
IEC 61000-4-6
6 Veff in the ISM
bands between
0.15 MHz and 80
MHz
80% AM at 2 Hz
Radiated RF
3 V/m
disturbances
80 MHz to 2.7 GHz
IEC 61000-4-3,
80% AM at 2 Hz
including clause
including clause
8.10, Table 9, for the
8.10, Table 9, for
proximity of non-
proximity to
related devices
wireless devices
NOTE 1 At 80 MHz and 800 MHz, the highest frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflections from structures, objects and people.
a) The field strengths of fixed transmitters, such as base stations for radiotelephones (cellular/wireless) and land mobile radios, amateur radio, AM and FM
broadcasting, and TV broadcasting, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters,
an on-site electromagnetic investigation should be considered. If the field strength, measured at the location where the BIOSTIM is used, exceeds the applicable
RF compliance level above, the BIOSTIM should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or repositioning the BIOSTIM.
b) Beyond the frequency range of 150 kHz to 80 MHz, field strengths should be less than 3V/m.
Recommended separation distances between portable and mobile devices of
The BIOSTIM is intended for use in an electromagnetic environment in which radiated RF interference is controlled. The
customer or user of the BIOSTIM can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the BIOSTIM, as recommended below,
depending on the maximum emission power of the communications equipment.
Maximum rated
output power of
the transmitter (in
W)
0.01
0.1
1
10
100
For transmitters with maximum rated transmit power not given 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 transmit power characteristic of the transmitter in watts (W), according to the
transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the highest frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflections from structures, objects and
people.
Level of
compliance
3 Vrms
150 kHz to 80 MHz
6 Veff in the ISM
bands between
0.15 MHz and 80
MHz
80% AM at 2 Hz
3 V/m
80 MHz to 2.7 GHz
80% AM at 2 Hz
including clause
8.10, Table 9, for
proximity to wireless
devices
RF communications and theBIOSTIM
Separation distance according to the frequency of the transmitter (in m)
150kHz - 80MHz
0.117
0.369
1.167
3.690
11.67
Page 39 of 40
Electromagnetic environment - guidelines
It is appropriate that portable and mobile devices of
RF communications are not used closer to any part of
the BIOSTIM, including cables, than the recommended
separation distance, calculated from the equation
applicable to the frequency of
the transmitter.
Recommended separation distance
WhereP is the maximum output power characteristic of
the transmitter in watts (W), according to the
transmitter manufacturer, and d is the recommended
separation distance in meters (m).
The field strengths of fixed RF transmitters, as
determined by an on-site electromagnetic
investigation a, should be below the compliance level
in each frequency range b
Interference may occur in the vicinity of the device
marked with the following symbol:
80MHz - 800MHz
0.117
0.369
1.167
3.690
11.67
MEG010XN102-A10
80MHz-800MHz
800MHz-2,5GHz
800MHz - 2.5GHz
0.233
0.737
2.330
7.368
23.300
12/04/2022