Product Specifications. HealthSmart 18-210-000 Compact Infrared Ear Thermometer

Specifications

• Product Name: Compact Infrared Ear Thermometer

• Model: 18-210-000 / TH1009C

• Power supply: DC 3V (2 x AAA battery)

• Ear Measuring Range: 89.6°F –109.3°F (32.0°C – 42.9°C)

Laboratory Measuring Accuracy: ± 0.4°F (or ± 0.2°C)

from 95°F –107.6°F (or 35°C – 42.0°C) ± 0.5°F ( ± 0.3°C) for other temperature

range

• Ambient Temperature Range : 41.0°F –139.8°F (5.0°C – 59.9°C)

• Ambient Temperature Accuracy: ± 2°F (± 1°C)

• Measurement Time: 1 Second

• Resolution: 0.1°F (0.1°F)

• Dimension: 5.18 (L) x 1.48 (W) x 1.46 (D) in. [131.8(L) x 37.7(W) x 37.3(D) mm]

• Weight: 53.54g (without batteries)

• Operation Temperature : 50.0°F – 104.0°F (10°C – 40°C)

• Operation Relative Humidity: 15% RH – 85%

• Storage & Transportation Temperature : -4°F – 131°F (-20°C – 55°C)

• Storage & Transportation Relative Humidity: 15% RH – 90% RH

• Service Life: 2 years

• Battery Life: Approximately 6 months with 5 tests per day

Normalized Symbols

Applied part of type BF

Disposal in accordance with Directive

2012/19/EU (WEEE)

The name and the address of the manufacturer.

Caution

Refer to Instruction Manual.

IP22 Serial Number

Date of Manufacture

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Normalized Symbols

IP22 The first number 2: Protected against solid foreign objects of

12,5 mm Ф and greater. The second number: Protected against vertically falling water drops when enclosure tilted up to 15º.

Vertically falling drops shall have no harmful effects when the enclosure is tilted at any angle up to 15º on either side of the vertical.

Important Information Regarding Electromagnetic

Compatibility (EMC)

With the increased number of electronic devices such as PC’s and mobile

(cellular) telephones, medical devices in use may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in incorrect operation of the medical device and create a potentially unsafe situation. Medical devices should also not interfere with other devices.

In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent unsafe product situations, the EN60601-1-2 standard has been implemented. This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices. Medical devices manufactured by HealthSmart

International conform to this EN60601-1-2:2007 standard for both immunity and emissions.

Nevertheless, special precautions need to be observed: The use of accessories and cables other than those specified by manufacturer, with the exception of cables sold by manufacturer as replacement parts for internal components, may result in increased emission or decreased immunity of the device.

• The medical devices should not be used adjacent to or stacked with other

equipment. In case adjacent or stacked use is necessary, the medical device

should be observed to verify normal operation in the configuration in which

it will be used.

• Refer to further guidance below regarding the EMC environment in which

the device should be used.

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Guidance and Manufacturer’s Declaration

(Table 1)

Guidance and manufacturer’s declaration

– electromagnetic emissions

The thermometer are intended for use in the eIectromagnetic enviroment specified below. The customer or the user of these thermometer should assure that it is used in such environment.

Emissions test Compliance

RF emissions

CISPR 11

Group 1

Electromagnetic environment

- guidance

The thermometer use 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.

RF emissions

CISPR 11

Harmonic emissions

IEC 61000-3-2

Voltage fluctuations/ flicker emissions

IEC61000-3-3

Class B

Not applicable

Not applicable

The thermometer are suitable for use in all establishments, including domestic establishments and those directly connected to the public low-vo ltage power supply network that supplies buildings used for domestic purposes.

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(Table 2)

Guidance and manufacturer’s declaration

– electromagnetic immunity

The thermometer are intended for use in the eIectromagnetic enviroment specified below. The customer or the user of these thermometer should assure that it is used in such environment.

Immunity test

Electrostatic discharge

(ESD)

IEC 61000-4-2

IEC 60601

Test level

± 6 kV contact ±8 kV air

Electrical fast transient/burst

IEC 61000-4-4

Surge

IEC 61000-4-5

Not applicable

Not applicable

Voltage dips, short interruptions and voltage variations on power supply

IEC 61000-4-11

Not applicable

Power frequency (50/

60 Hz) magnetic field

IEC 61000-4-8

3A/m

Compliance level

± 6 kV contact ±8 kV air

Electromagnetic environment – guidance

Floor should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Not applicable

Not applicable

Not applicable

Not applicable

3A/m

Not applicable

Not applicable

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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(Table 4)

Guidance and manufacturer’s declaration

– electromagnetic immunity

The thermometer are intended for use in the electromagnetic environment specified below. The customers or the users of these thermometer should assure that it is used in such environment.

Immunity test

IEC 60601

Test level

Compliance level

Electromagnetic environment – guidance

Conducted

RF

IEC 61000

-4-6

Radiated

RF IEC

61000-4-3

Not applicable

3 V/m

80 MHz to

2.5 GHz

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the thermometer including cables, than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter.

Recommend separation distance d = 1.2 √ P d = 1.2 √ P 80 MHz to 800 MHz d = 2.3 √ P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to he transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters as determined by an electromagnetic site survey,

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a. should be less than the compliance level in each frequency range.

b. Interference may occur in the vicinity of equipment marked with he following symbol:

Note1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note2: These guidelines may not apply in all situations.

Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

a Field strengths from fixed transmitters, such as base stations for

radio (cellular/ cordless) telephones and land mobile radio, AM and

FM radio broadcast, and TV broadcast cannot be predicted theoretically

with accuracy. To assess the electromagnetic environment

due to fixed RF transmitters, an electromagnetic site survey should

be considered. If the measured field strength in the location in which

the thermometer are used exceeds the applicable RF

compliance level above, the thermometer should be

observed to verify normal operation. If abnormal performance is

observed, additional measures may be necessary, such as

reorienting or relocating the thermometer.

b

Over the frequency range 150 kHz to 80MHz, field strengths should

be less than 3 V/m.

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(Table 6)

Recommended separation distance between portable and mobile

RF communications equipment and the thermometer

The thermometer are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customers or the users of these thermometer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the thermometer as recommended below, according to the maximum output power of the communications equipment.

Output Power of

Transmitter in

Watt

0.01

0.1

1

10

Separation distance according to frequency of

transmitter in meter

150 kHz to

80 MHZ d = 1.2

0.12

√

80 MHz to

800 MHZ d = 1.2 √

0.12

800 MHz to

2.5GHz

d = 2.3

0.23

√

0.38

1.2

3.8

0.38

1.2

3.8

0.73

2.3

7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts

(W) according to the transmitter manufacturer.

Note: At 80MHz and 800MHz, the separation distance for the higher frequency range applies

Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

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