GB

FRONT COVER

LCD

ON/MEMORY

BUTTON

BATTERY COVER

On/Mem

WORLDWIDE

SMALLEST PROBE

DIAMETER

=5.9MM

LENS PROBE

HYGIENE COVER

SCAN

BUTTON

HYGIENE

COVER

DETECTOR

REAR COVER

INSTRUCTIONS FOR USE

Before first use, pull to remove the tab from the battery cover.

INSTALLING THE HYGIENE COVER

WARNING: Choking from swallowing probe covers and connection ring by children or pets is possible, please keep the probe covers and connection ring at places where children and pets can’t reach.

1. Gently twist the probe cap to remove. Always use a new and undamaged hygiene cover before each reading. Ensure the ear canal is clean.

1

HYGIENE

COVER

2

CONNECTION

RING

2. Place a new hygiene cover into the connection ring. See diagram 1.

3. Insert the thermometer probe into the centre of the hygiene cover and connection ring.

See diagram 2.

4. Push until it is secure. If the hygiene cover did not connect firmly, this icon will be flashing on the LCD screen. Remove the hygiene cover and re-install.

Correct installation of the hygiene cover ensures accurate readings.

°C

3 4

5. Press ‘On/Mem’ button. The thermometer is ready for use when the ear icon stops flashing and two short beeps have sounded.

6. Gently pull the baby’s ear back, straightening the ear canal. Position the probe snugly into the ear canal, ensuring an accurate reading. See diagram 3 and 4.

7. To measure the ear temperature, press the ‘Scan’ button until there is a long beep.

The LCD screen will light up automatically after pressing the scan button, and will automatically turn off after 5 seconds.

8. The temperature will show clearly on the LCD display.

9. To power off, hold down the ‘On/Mem’ button for approximately 5 seconds, until the LCD screen shows ‘off’. The thermometer will automatically shut down after 1 minute if it is not turned off, prolonging the battery life.

FEVER ALARM

If the thermometer detects a body temperature ≥37.5°C (99.5°F), one long beep will sound followed by three short beeps to warn the user of potential fever.

SWITCHING BETWEEN FAHRENHEIT (°F) AND CELSIUS (°C)

1. In ‘Power off’ mode, press and hold the ‘Scan’ button.

2. Then press the ‘On/Mem’ button for 3 seconds whilst still holding the scan button. The ‘°C’ will change to ‘°F’. You can use the same process to change from ’°F’ back to ‘°C’.

MEMORY FUNCTION

1. Press the ‘On/Mem’ button again to see the last temperature stored.

The thermometer will automatically save the last reading into the memory, if it is within the temperature range of 34°C to 42.2 °C (93.2 °F to 108.0°F).

CLEANING AND STORAGE

The probe is the most delicate part of the thermometer. When cleaning the lens handle with care to avoid damage. If device is accidentally used without hygiene cover, clean the probe as follows:

1. Use a cotton swab (Alcohol 70% concentration) to clean the lens found inside the probe.

2. Allow the probe to fully dry for at least 1 minute.

The thermometer should be stored at temperature between -20°C to +50°C.

Keep the unit dry and away from any liquids and out of direct sunlight.

The probe should not be submerged in any liquids.

If the thermometer is used according to the instructions, periodic re-adjustment is not required.

CHANGING THE BATTERY

Keep the battery away from children.

This device is supplied with one lithium cell battery (CR2032).

1. Unscrew battery cover.

2. Flip the battery out with a small screw driver.

3. Insert the new battery under the metal hook on the left side and press the right side of the battery down firmly. See diagram 5.

4. Replace the battery cover.

5

On/Mem

The positive (

CR

+) side up and the negative (-) side pointed down.

SPECIFICATIONS

Temperature measurement range: 34-42.2°C (93.2-108°F)

Operating temperature range: 10-40°C (50-104°F), RH<85%

Storage temperature range: -20-+50°C, RH

≤ 85%

Transportation temperature: < than 70°C, RH

≤

95%,

Atmospheric pressure: 800~1013 hPa

Enclosure Rating: IP22

Dimensions: 149.1 x 42.5 x 54.9 mm

Weight: 79.7 grams including battery

Battery life: around 3,000 readings. Enable normal use: 1 year

Expected Service Life: 4 years

Complies with ASTM E1965-98, EN12470-5:2003 Clinical thermometers-Part 5: Performance of infra-red ear thermometers (with maximum device), IEC/EN60601-1-2(EMC),IEC/EN60601-1(Safety) standards.

Accuracy: +/-0.2 °C (0.4 °F) in a temperature range of 35.5-42°C (95.9-107.6°F). Accuracy of +/-0.3 °C

(0.5 °F) for other temperature ranges.

This thermometer converts the ear temperature to display its “oral equivalent.” (according to the result of the clinical evaluation)

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 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 radios, amateur 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 Digital Ear Thermometer is used exceeds the applicable RF compliance level above, the Digital Ear Thermometer should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Digital Ear Thermometer.

b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

The Digital Ear Thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of the Digital Ear Thermometer. should assure that it is used in such an environment.

Immunity test

Electrostatic discharge (ESD)

IEC 61000-4-2

IEC 60601 test level

6 kV contact

8 kV air

Compliance level

6 kV contact

8 kV air

Electromagnetic environment – guidance

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

Mains power quality should be that of a typical commercial or hospital environment.

Electrical fast transient/burst

IEC 61000-4-4

Surge

IEC 61000-4-5 interruptions and voltage variations on power supply input lines

IEC 61000-4-11

2 kV for power supply lines

1 kV for input/output lines

1 kV line(s) to line(s)

2 kV line(s) to earth

<5 % UT

(>95 % dip in UT) for 0,5 cycle

40 % UT

(60 % dip in UT) for 5 cycles

70 % UT

(30 % dip in UT) for 25 cycles

<5 % UT

(>95 % dip in UT) for 5 sec

Not applicable

Not applicable

Not applicable

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Digital Ear Thermometer requires continued operation during power mains interruptions, it is recommended that the Digital Ear Thermometer be powered from an uninterruptible power supply or a battery.

Power frequency

(50/60 Hz) magnetic field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF

(RADIO FREQUENCY) COMMUNICATIONS EQUIPMENT AND THE ME EQUIPMENT

OR ME SYSTEM

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

Rated maximum output power of transmitter

W

Separation distance according to frequency of transmitter m

0,01

0,1

1

10

150 kHz to 80 MHz d = 1,2 √P

0,12

0,38

80 MHz to 800 MHz d = 1,2 √P

0,12

0,38

800 MHz to 2,5 GHz d = 2,3 √P

0,23

0,73

1,2

3,8

1,2

3,8

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 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

TROUBLESHOOTING

ERROR

MESSAGE

PROBLEM

Device stabilization in process.

SOLUTION

Wait until stops flashing.

Battery is low and no more measurements are possible.

Replace the battery.

Measurement before device stabilization.

Wait until stops flashing.

The device showing a rapid ambient temperature change.

Allow the thermometer to rest in a room for at least 30 minutes at room temperature:

10 °C and 40 °C (50 °F ~104 °F).

The ambient temperature is not within the range between 10 °C and 40 °C (50 °F

~104 °F).

Allow the thermometer to rest in a room at least 30 minutes at room temperature: 10 °C and 40 °C (50 °F ~104 °F).

Error 5~9, the system is not functioning properly.

Temperature taken is higher than 42.2 °C

(108.0 °F).

Temperature taken is lower than 34 °C

(93.2 °F).

Unload the battery, wait for 1 minute and repower it.

Check the integrity of the hygiene cover and take a new temperature measurement.

Make sure the hygiene cover is clean and take a new temperature measurement.

Device can not be powered on to the ready stage.

Insert a new battery.

It is recommended that you measure 3 times in the same ear. If the 3 measurements are different, select the highest temperature.

There is no gender and age limitation for using infrared thermometers.

Clinical repeatability 0.18°C newborn to 1 year old, 0.17°C 1-5years old, 0.15°C 5years+

Holding the thermometer too long may cause a higher ambient temperature reading. This could make the body temperature measurement lower than usual.

This product comes with a 12 month warranty. Manufacture Date ：as the serial number (please open the battery cover, it is shown on the inside of the device.) Ex.SN:E912A000001, the first “E” is External, the second number “9” is the manufacture year 2009, the third and the fourth number “12” is the manufacture month, the remaining figures are the serial number.

BF type applied part

SYMBOL DESCRIPTIONS

0120

The CE mark and Notified

Body Registration

Numbers, the requirement of Annex II from Medical Device

Directive 93/42/EEC are met.

Please read the instructions for use

BF type applied part

WEE/JC0045SY

Indicates this device is subject to the

Waste Electrical and Electronic

Equipment Directive in the European

Union. To protect the environment, dispose of useless device at appropriate collection sites according to national or local regulations.

Paper Recycling

Battery Recycling

2

Caution

Do not reuse

Manufacturer

EC REP

Authorized representative in the European community

IP22 Classification for water ingress and particulate matter.

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS

The Digital Ear Thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of the Digital Ear Thermometer should assure that it is used in such an environment.

Emissions test

RF emissions

CISPR 11

Compliance

Group 1

Electromagnetic environment – guidance

The Digital Ear Thermometer uses RF (Radio

Frequency) 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

IEC 61000-3-3

Class B

Not applicable

Not applicable

The Digital Ear 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.

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

The Digital Ear Thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of the Digital Ear Thermometer should assure that it is used in such an environment.

Immunity test IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to

80 MHz

3 V/m

80 MHz to

2,5 GHz

Not applicable

3 V/m

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

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

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