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Document Title:
Document No.: DS101-SDUS01-01303
Product Name: Electronic Stethoscope DS101
510(k) File Name: 003_Electronic Stethoscope DS101 User Manual
The DS101 is intended for use in the electromagnetic environment (for professional healthcare) specified below.
The customer or the user of the DS101 should assure that is used in such and environment.
Immunity test
IEC 60601 test level
Conducted RF
3 Vrms
IEC 61000-4-6
0,15 MHz – 80 MHz
6 Vrms
in ISM bands between
0,15 MHz and 80
MHz
80 % AM at 1 kHz
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 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 DS101 is used exceeds the applicable RF
compliance level above, the DS101 should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the DS101
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Electronic Stethoscope DS101 User Manual
Manufacturer's declaration-electromagnetic immunity
Compliance level
Not applicable
:
Not applicable
:
e)
3 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
b)
c)
Electromagnetic environment-guidance
(for professional healthcare environment)
Portable and mobile RF communications
equipment should be used no closer to any
part of the DS101 including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance:
d = 1,2 √
P
d = 1,2 √
80MHz to 800 MHz
P
d = 2,3 √
800MHz to 2,7 GHz
P
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,
should be less than the compliance level in
b
each frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbol:
Page:
46 of 50
Ver.:
A1
Date:
2017/8/26
a
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