EN
The TheraFace Mask is intended for use in the electromagnetic environment specified below. The customer or the user of the TheraFace Mask should assure that it is used in such an environment.
IMMUNITY TEST
IEC 60601 TEST LEVEL
Conducted RF
3 Vrms
IEC 61000-4-6
150kHz to 80MHz
6 V in ISM and amateur radio
bands between 0,15 MHz and
80 MHz
Radiated RF
10 V/m
IEC 61000-4-3
80MHz to 2.5GHz
385MHz-5785MHz Test
specifications for ENCLOSURE
PORT IMMUNITY to RF
wireless communication
equipment (Refer to table 9 of
IEC 60601-1-2:2014)
a The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to
2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
b
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 TheraFace Mask is used exceeds the applicable RF compliance level above, the TheraFace Mask should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re¬orienting or relocating the TheraFace Mask.
c
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM - for EQUIPMENT and SYSTEMS
Recommended separation distances between portable and mobile RF communications equipment and the TheraFace Mask
The TheraFace Mask is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the
TheraFace Mask can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the TheraFace Mask as recommended below, according to the maximum output power of the communications equipment
Rated maximum
Separation distance according to frequency of transmitter
output of transmitter
m
W
150 kHz to 80 MHz
outside ISM and
amateur radio bands
0.01
0.12
0.1
0.38
1
1.2
10
3.8
100
12
13
13
COMPLIANCE LEVEL
3 Vrms
Portable and mobile RF communications equipment should be used no closer to any part of the TheraFace Mask, including
150kHz to 80MHz
cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
6 V in ISM and amateur radio
Recommended separation distance:
bands between 0,15 MHz and
80 MHz
where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and
10 V/m
d is the recommended separation distance in metres (m).
80MHz to 2.5GHz
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,
385MHz-5785MHz Test
specifications for ENCLOSURE
Interference may occur in the vicinity of equipment marked with the following symbol:
PORT IMMUNITY to RF
wireless communication
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
equipment (Refer to table 9 of
NOTE 2 These guidelines may not apply in all situations. Electromagnetic is affected by absorption and reflection from structures, objects and people.
IEC 60601-1-2:2014)
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150 kHz to 80 MHz
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0.20
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6.32
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ELECTROMAGNETIC ENVIRONMENT - GUIDANCE
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80 MHz to 800 MHz
80 MHz to 800 MHz
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0.07
0.11
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0.70
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80 MHz to 800 MHz
800 MHz to 2.7 GHz
should be less than the compliance level in each frequency range.
a
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.
b