Conformity Standards; Emc Tables - Chicco THERMO DISTANCE Manual Del Usuario

CONFORMITY STANDARDS

This products complies with the
essential requirements of MDD di-
rective 93/42/EE C . The following
standards have been applied during
product design and manufacturing:
• ASTM E1965-98 Standard Specifi-
cation for Infrared Thermometers
for Intermittent Determination of
Patient Temperature

EMC Tables

The Chicco Infrared No Contact Forehead Thermometer REF. 00006931000000 is intended for use in the
electromagnetic environment specified below. The customer or the user of the Chicco Infrared No Contact
Forehead Thermometer REF. 00006931000000 should assure that it is used in such an environment.
Guidance and manufacturer's declaration-electromagnetic emissions
Emissions test Compliance
RF emissions CISPR 11
RF emissions Class B
CISPR 11
Harmonic emissions Not applicable
IEC 61000-3-2
Voltage fluctuations Not applicable
Flicker emissions
IEC 61000-3-3
Guidance and manufacturer's declaration-electromagnetic immunity
Immunity IEC 60601
test Test level
Electrostatic discharge ±6kV contact
(ESD) IEC 61000-4-2 ±8kV air
Power frequency
3 A/m
(50/60 Hz) magnetic
field
IEC 61000-4-8
• IEC/EN 60601-1 Medical electrical
equipment -- Part 1: General require-
ments for basic safety and essential
performance
• IEC/EN 60601-1-2 Medical electri-
cal equipment - Part 1-2: General
requirements for basic safety and
essential performance - Collateral
standard: Electromagnetic compat-
ibility - Requirements and tests
Electromagnetic environment-guidance
The Chicco Infrared No Contact Forehead Thermometer
REF. 00006931000000 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.
The Chicco Infrared No Contact Forehead Thermometer
REF. 00006931000000 is suitable for use in all establish-
ments other that domestic and those directly connected to
the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Compliance Electromagnetic
Level guidance
±6kV contact Floor should be wood, concrete or
±8kV air ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Power frequency magnetic fields
3 A/m
should be at levels characteristic of a
typical location in a typical commer-
cial or hospital environment.
20
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