12. Standards
ASTM E1965-98
EN 12470-5
MDD (93/42/EEC) Annex II
13. Guidance and Manufacturer's Declaration
The 429 IR Thermometer is intended for use in the electromagnetic environment specified
below. The customer or the user of the 429 Thermometer should assure that it is used in such
an environment.
Emissions Test
Compliance
Electronic environment guidance
RF emissions CISPR 11
Group 1
RF emissions CISPR 11
Class B
Harmonic Emissions
IEC 61000-3-2
N/A
Voltage
Fluxuations/flicker
emissions
IEC 61000-3-3
N/A
The 429 IR Thermometer 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 429 IR Thermometer is suitable for use in all
establishments, including domestic establishments and
those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes.
The 429 IR Thermometer is intended for use in the electromagnetic environment specified
below. The customer or the user of the 429 IR Thermometer should assure that it is used in
such an environment.
Immunity Test
IEC 60601 Test level
Compliance
Electronic environment guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV air
Power Frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
3A/m
3A/m
Floors 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
commercial or hospital
environment.
Guidance and Manufacturer's Declaration Electromagnetic emissions
16
5
2. Introduction / Intended Use
Intended use
The Adtemp Non-Contact thermometer is a clinical-grade device intended for
the intermittent measurement of human body temperature in patients of all
ages. It can also be used to measure the temperature of objects.
3. General Warnings and Cautions
Warning and caution statements may appear on the thermometer,
its packaging, shipping container, or in this instruction manual.
This thermometer is safe for patients and clinicians when used in accor-
dance with the instructions and with the warning and caution statements in-
cluded in this manual. Before using the thermometer, users must familiarize
themselves with the general safety information included below. Specific
warnings and cautions are also found throughout this manual.
• Failure to understand and observe any warning statement in this
manual could lead to patient illness, injury, or death.
• Failure to understand and observe any caution statement in this
manual could lead to damage to the thermometer or other property,
damage to the surrounding environment, or loss of patient data.
• High, prolonged fever requires immediate medical attention,
especially for young children.
Warning:
Failure to review and adhere to the recommendations presented
in this manual could result in personal injury or could affect the accuracy of
the thermometer itself.
Miscellaneous Symbols
Type BF applied part
Battery Level Indications
Low battery - thermometer can still be used
Low battery - the batteries must be replaced before further operation
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