Owner's Manual

Warranty
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The device satisfies the EMC requirements of the international
standard IEC 60601-1-2. The requirements are satisfied under
the conditions described in the table below. The device is an
electrical medical product and is subject to special precautionary
measures with regard to EMC which must be published in the
instructions for use. Portable and mobile HF communications
equipment can affect the device. Use of the unit in conjunction
with non-approved accessories can affect the device negatively
and alter the electromagnetic compatibility. The device should
not be used directly adjacent to or between other
electrical equipment.
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Electromagnetic Compatibility Information
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Electromagnetic Compatibility Information Electromagnetic Compatibility Information
Table 1
Guidance and declaration of manufacturer-electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
Electromagnetic environment-guidance
ComplianceEmissions test
The device uses RF energy only for its internal function.
Therefore, its emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
Group 1
RF emissions CISPR 11
The device 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.
Class BRF emissions CISPR 11
Harmonic emissions
IEC 61000-3-2
N/A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
N/A
Table 2
Guidance and declaration of manufacturer-electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Electromagnetic environm
entguidance
Compliance
level
IEC 60601 test level
IMMUNITY test
± 6 kV
contact
± 8 kV air
± 6 kV
contact
± 8 kV air
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrostatic
transient/burst
IEC 61000-4-4
± 2 kV for
power supply
lines
± 1 kV for
input/output
lines
N/A
Surge
IEC 61000-4-5
± 1 kV
differential
mode
± 2 kV
common
mode
N/A
Voltage dips,
short interrupti-
ons and voltage
variations on p-
ower supply in-
put lines
IEC 61000-4-11
< 5% UT (>95% dip in UT)
for 0.5 cycle
40% UT (60% dip in UT)
for 5 cycle
70% UT (30% dip in UT)
for 25 cycle
<5% UT (>95% dip in UT)
for 5 sec
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
Power frequency magnetic fields
should be at levels charactertic of a
typical location in a typical comme-
rcial or hospital environment.
3 A/m
N/A
This appliance conforms to the following standards:
ASTM E1965-98 Standard Specification for Infrared Thermometers
for Intermittent Determination of Patient Temperature,
ISO 80601-2-56 Medical electrical equipment —Part 2-56:
Particular requirements for basic safety and essential performance
of clinical thermometers for body temperature measurement,
IEC 60601-1-11 Medical electrical equipment —Part 1-11: General
requirements for basic safety and essential performance –Collateral
Standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment
and complies with the requirements of IEC 60601-1-2(EMC) ,
AAMI/ANSI ES60601-1(Safety) standards. And the manufacturer
is ISO 13485 certified.
Thermometer is warranted by manufacture to be free from defects in
material and workmanship under normal use and service for a period
of one year from the date of delivery to the first user who purchases
the instrument. This warranty does not cover batteries, damage to the
probe window, or damage to the instrument caused by misuse,
negligence or accident, and extends to only to the first purchaser of
the product.