Conformity Standards - Chicco THERMO DISTANCE Instructions For Use Manual

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:
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
RF emissions
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations
Flicker emissions
IEC 61000-3-3
Guidance and manufacturer's declaration-electromagnetic immunity
Immunity
test
Electrostatic discharge
(ESD) IEC 61000-4-2
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
Compliance Electromagnetic environment-guidance
CISPR 11 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.
Class B 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
Not applicable
the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Not applicable
IEC 60601 Compliance
Test level Level
±6kV contact ±6kV contact
±8kV air ±8kV air
3 A/m 3 A/m
equipment -- Part 1: General require-
ments for basic safety and essential
performance
cal equipment - Part 1-2: General
- requirements for basic safety and
essential performance - Collateral
standard: Electromagnetic compat-
ibility - Requirements and tests
Electromagnetic
guidance
Floor should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commer-
cial or hospital environment.
20
-
environment-