Appendix B Declaration Of Manufacturer - Henry Schein 900-8275 Manuel D'utilisation

ENGLISH
Guidance and manufacturer's declaration - Electromagnetic emission----
for all EQUIPMENT AND SYSTEM
1 Guidance and manufacturer's declaration - electromagnetic emission
2 The model HS Pulse Oximeter is intended for use in the electromagnetic specified below. The customer or
the user of the model HS Pulse Oximeter should assure that it is such an environment.
3 Emissions test Compliance
4 RF emissions Group 1
CISPR11
5 RF emissions Group B
CISPR11
6 Harmonic Class A
emissions
IEC 61000-3-2
7 Voltage Complies
fluctuations/IEC
61000-3-3
Guidance and manufacturer's declaration - Electromagnetic Immunity-
For all Equipment and Systems
Guidance and manufacturer's declaration- electromagnetic immunity
The model HS Pulse Oximeter is intended for use in the electromagnetic environment specified below. The
customer or the user of the model HS Pulse Oximeter should assure that it is used in such an environment.
Immunity IEC 60601 test
test level
Electrostatic ±6kV contact
discharge ±8kV air
ESD IEC
61000-4-4
Electrostatic ±2kV for power
transient/bur supply
st ±1kV
IEC input/output
61000-4-4 lines
Surge IEC ±1kV
61000-4-5 differential
mode
common mode
Voltage dips, <5%
short ( >95%dip in
interruptions UT) for
and voltage cycles 40% UT
variations (60%dip in UT)
on power for 5 cycles
supply input 70%
lines IEC UT( 30%dip in
61000-4-1 UT) For 2 5
cycles <5% UT
( >95%dip in
UT) for 5 sec
Power 3A/m
frequency
(50/60Hz)
magnetic
field IEC
61000-4-8
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer's declaration- electromagnetic immunity-
For EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING
Guidance and manufacturer's declaration – electromagnetic immunity
The model HS Pulse Oximeter is intended for use in the electromagnetic specified below. The customer of the
user of the HS Pulse Oximeter should assure that it is used in such an environment.
Immunity IEC 60601 test
test level
Conduct 3Vrms 150kHz
ed RF to 80kHz
IEC
61000-4-
6
3V/m 80MHz to

APPENDIX B Declaration of Manufacturer

Electromagnetic environment-guidance
The model HS Pulse Oximeter uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
Compliance level
±6kV contact ±8kV
air
±2kV for power
lines supply lines ±1kV
for for input/output
lines
±1kV differential
mode ±2kV
±2kV common mode
UT <5% UT ( >95%dip
in UT) for 0.5 cycles
0.5 40% UT (60%dip in
UT) for 5 cycles
70% UT (30%dip in
UT) For2 5 cycles
<5% UT ( >95%dip
in UT) for 5 sec
3A/m
Compliance Electromagnetic environment-guidance
level
Portable and mobile RF communications equipment should be
used no closer to any part of the model HS Pulse Oximeter,
3V including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the
transmitter.
Recommended separation distance
Electromagnetic environment-guidance
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
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment. If the user of the
model HS Pulse Oximeter requires continued operation
during power main Interruptions, it is recommended
that the model HS Pulse Oximeter be powered from an
uninterruptible power supply or a battery.
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
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