Imediplus DS101 User Manual page 45

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 it is used in such an environment.
Immunity test
Electrostatic
Contact:±8 kV
discharge(ES
Air±2 kV,±4 kV,±8 kV,±
D) IEC 61000-
15 kV
4-2
Electrical fast + 2kV for power supply
transient/burst lines
IEC 61000-4-4 + 1kV for input/output
lines
Surge IEC + 0.5kV, +1kV line(s) to
61000-4-5 line(s)
+ 0.5kV, +1kV,+ 2kV
line(s) to earth
Voltage Dips, Voltage dips:
short 0 % U
interruptions % U ; 1 cycle
T
and voltage 70 % U
variations on
power supply Voltage interruptions:
input lines IEC 0 % U
61000-4-11
Power 30 A/m
frequency(50, 50 Hz or 60 Hz
60 Hz)
magnetic field
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
Electronic Stethoscope DS101 User Manual
Manufacturer's declaration-electromagnetic immunity
IEC 60601
test level
Contact:±8 kV
Air±2 kV,±4 kV,±8 kV,±15 kV
Not applicable
Not applicable
Not applicable
Not applicable
Voltage dips:
; 0,5 cycle 0 Not applicable
T
Not applicable
; 25/30 cycles Not applicable
T
Voltage interruptions:
; 250/300 cycle Not applicable
T
30 A/m
50 Hz and 60 Hz
Compliance level
Page:
Ver.:
Date:
Electromagnetic environment-
guidance (for professional
healthcare environment)
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30%
Mains power quality should be that of
a typical professional healthcare
environment.
Mains power quality should be that of
a typical professional healthcare
environment.
Mains power quality should be that of
a typical professional healthcare
environment. If the user of the
DS101 requires continued operation
during power mains interruptions, it
is recommended that the DS101 be
powered from an uninterruptible
power supply or a battery.
The DS101 power frequency
magnetic fields should be at levels
characteristic of a typical location in
a typical professional healthcare
environment.
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2017/8/26