User's Manual

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Guidance and manufacturer’s declaration – electromagnetic immunity
The smartho-D2 is intended for use in the electromagnetic environment specified below. The customer or the user of the
smartho-D2 should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
6 Vrms 150 kHz
to 80 MHz
outside ISM
bandsa
10 V/m
80 MHz to
2.7 GHz
N/A
10 V/m
Portable and mobile RF communications equipment should be
used no closer to any part of the Models smartho-D2, including
cables, than the recommended separation distance calculated
from the equation applicable to the frequency of the transmitter.
Recommended separation distance
P
V
d
ú
û
ù
ê
ë
é
=
1
5.3
P
E
d
ú
û
ù
ê
ë
é
=
1
5.3
80MHz to 800MHz
P
E
d
ú
û
ù
ê
ë
é
=
1
7
800MHz to 2.7GHz
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 affected by absorption and
reflection from structures, objects and people.
a The ISM (industrial, scientific and medical) bands between 0,15 MHz 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 The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to
2,7 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause
interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 has been
incorporated into the formulae used in calculating the recommended separation distance for transmitters in these
frequency ranges.
c 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 smartho-D2 is used exceeds the applicable RF
compliance level above, the smartho-D2 should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the smartho-D2.
d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
510(K) Response to Deficiency on K191667-S001
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