Alvita 376-5690 User manual

Infrared Ear Thermometer

Thermomètre auriculaire à infrarouge

Infrarot-Ohrthermometer

Termometro auricolare a infrarossi

Termómetro de oído por infrarrojos

Termómetro Auricular de Infravermelhos

2 3

The Alvita Infrared Ear Thermometer has been carefully developed for accurate, safe and

fast temperature measurements in the ear. It is a non-invasive ear thermometer using an

infrared detector to detect body temperature in the ear canal for adults and children.

The quality of the Alvita Infrared Ear Thermometer has been veriﬁed and conforms to

the provisions of the EC council directive 93/42/EEC (Medical Device Directive) Annex I

essential requirements and applied harmonised standards, including EN 12470-5:2003

Clinical thermometers-Part 5: Performance of infrared ear thermometers (with maximum

device)

Contents

Infrared Ear Thermometer 2

Contents 2

Introduction 3

Health advice 3

Thermometer Parts 3

LCD Display 3

How to use the Alvita Infrared Ear Thermometer 4

Scanning Mode 6

Cleaning and Storage 6

Memory function 6

Switching the sound o 6

Switching between Fahrenheit and Celsius 7

Replacing the battery 7

Troubleshooting 8

Caution 8

Speciﬁcation 9

Introduction

Health advice

- Consult a doctor if you feel that you are in poor health

- Do not judge your health only on the presence or absence of a fever.

- Measurement results are for reference only, diagnosis or treatment should be made

on the advice of a healthcare professional.

Thermometer Parts

LCD Display

The device is ready to measure temperature and that a

probe cover should be used.

When the battery icon shows, please replace the battery

ON/OFF

Memory

button

EarProbe

Temperature

Display

°C/°F Scale

Battery

LCD

Display

Battery

cover

Probe cover

Temperature button

4 5

How to use the Alvita Infrared Ear Thermometer

To obtain accurate measurements, make sure a new, clean probe cover is attached to

the thermometer before each measurement and that the ear canal is clean.

Step 1

Attach the probe cover by rotating it clockwise to lock into position.

(Remove the probe cover by rotating it anti-clockwise to release).

The correct attachment of the probe cover ensures accurate temperature

measurements.

This thermometer must only be used with Alvita probe covers. Other covers can

lead to inaccurate measurements. Replacement Alvita probe covers can be

purchased from your local retailer.

Step 2

Press the grey “On/O Memory” button. The thermometer is ready to use when the

ear icon ﬂashes and two beeps sound.

When the device has been stored below 10°C (50°F) or above 40°C (104°F), place

it in the correct temperature range for at least 30 minutes before use.

Step 3

Gently pull the ear upwards and back to straighten the ear canal and snugly position the

probe into the ear canal.

The ear thermometer must be inserted

correctly into the ear to obtain the correct

temperature measurement.

This thermometer is only designed to measure

the ear temperature.

Do not use it in any other body site

Step 4

Press the blue “Temperature” button. A long beep will sound when the measurement

is complete.

For the next measurement, remove the used probe cover and attach a new one.

Replace the probe cover after use, to ensure an accurate measurement and avoid

cross contamination.

Only use Alvita probe covers.

Step 5

If the recorded temperature:

Is lower than 34°C (93.2°F) The display will show “Lo”

(4 short beeps will sound)

Is between 34°C (93.2°F) and 37.5°C (99.5°F) The display will show the temperature

1 long beep will sound)

Is higher than 37.5°C (99.5°F) Fever Alarm:

The display will show the temperature ﬂashing

(4 short beeps will sound)

Is higher than 42.2°C (108.0°F) The display will show “Hi”

(4 short beeps will sound)

It is recommended that you take 3 measurements from the same ear. If the 3

measurements dier, select the highest temperature.

Step 6

The device will automatically shut o if unused for more than 1 minute, to maintain

the battery life. Alternatively press the grey “On/O Memory” button for at least 3

seconds to turn the device o.

Step 7

The probe must be cleaned after use, according to the “Cleaning and Storage”

instructions, to avoid cross contamination.

Probe

Cover

Turn

Clockwise

to lock

6 7

Scanning Mode

If you continuously obtain dierent measurements, it is recommended that you use

Scanning Mode. This mode allows you to measure the temperature of the entire ear

canal to ﬁnd the highest temperature.

To use the Scanning Mode gently pull the ear upwards and back to straighten the

ear canal and snugly position the probe into the ear canal. Press and hold the blue

“Temperature” button for 3 seconds until hearing a long beep. While holding the blue

“Temperature” button gently pivot the probe from side-to-side within the ear. A

further two beeps will sound to indicate that the thermometer is ready to take another

measurement.

Cleaning and Storage

The probe is the most delicate part of the thermometer. Care should be taken when

cleaning the lens, to avoid damage.

1. A cotton swab dipped in Alcohol (70% concentration) should be used to clean

the lens.

2. Allow the probe to dry for at least 5 minutes. Keep the device dry and away from any

liquid and direct sunlight. The probe should not be submerged into liquids.

Memory function

If the measurement is within the range 34°C to 42.2°C (93.2°F to 108°F), the

measurement is saved to the memory.

The thermometer stores 9 recent measurements in the memory

To review the measurements in the memory:

1. Turn the device on

2. Press the grey “ON/OFF/Memory” button again, to display the

measurements stored.

Switching the sound o

1. Turn the device o

2. Hold down the blue “Temperature” button, then press and hold the

grey “ON/OFF/Memory” button until the LCD shows °C. Release both buttons.

3. Press the grey “ON/OFF/Memory” button again to switch the sound o, then

release the button.

4. Use the same process to turn the sound on.

Switching between Fahrenheit and Celsius

1. Turn the device o.

2. Hold down the blue “Temperature” button then press and hold the grey

“ON/OFF/Memory” button until the LCD shows °C. Release both buttons.

3. Press the blue “Temperature” button again to change the °C to °F,

then release the button.

4. Use the same process to change the LCD display from °F to °C.

Replacing the battery

The thermometer is provided with one lithium battery (CR2032).

1. Turn o the thermometer before replacing the battery.

2. Open the battery cover, and ﬂip the battery out with a small screwdriver.

3. Insert the new battery with the positive (+) side up. Press it down until you hear

a click.

4. Replace the battery cover.

8 9

Troubleshooting

Error Message Problem Solution

bi-bi-bi

The room temperature is

outside the operating range for

the device: 10°C to 40°C

(50°F to 104°F)

Allow the thermometer to rest for at least 30 minutes

at room temperature: 10°C to 40°C (50°F to 104°F)

bi-bi-bi

The system is not functioning

properly.

Remove the battery, wait for 1 minute, replace it &

turn the device on. If the message reappears, contact

the retailer for advice.

The device does not start Change the battery. If the message reappears, contact

the retailer for advice.

bi-bi-bi-bi

Temperature taken is higher

than 42.2°C (108.0°F)

Check that the probe cover is attached correctly, clean

and take a new measurement.

bi-bi-bi-bi

Temperature taken is lower than

34°C (93.2°F)

Check that the probe cover is attached correctly, clean

and take a new measurement.

Low battery: The battery icon

ﬂashes but can still be used.

Replace the battery soon.

Dead battery: The battery icon

is permanently displayed - no

further measurements can

be taken.

Replace the battery.

Caution

1. Please note that this is a home healthcare device only, and it is not intended to serve as a substitute for the advice

of a physician or medical professional.

2. Temperature measurements from the Alvita Infrared Ear Thermometer are comparable with measurements taken

from an oral thermometer.

3. Temperature measurements from the Alvita Infrared Ear Thermometer cannot be compared with measurements

taken from the rectum or underarm

4. Measurements can be taken regularly to ﬁnd out the normal ear temperature, and can be used as the basis for

comparison with measurements taken when a fever is suspected.

5. Do not use the device if it operates irregularly or any error message is showing.

6. Clean the device before storing.

7. This device may not meet its performance speciﬁcation if it is stored or used outside temperature and humidity

ranges speciﬁed in this booklet.

8. Keep the device dry and away from where it might be exposed to moisture, liquids, direct sunlight, high

temperature, or excessive dust.

9. This device is not shock-protected. Do not drop or expose to heavy shock.

10. Do not bend the device.

11. Do not disassemble or make modiﬁcations to the device.

12. Please do not dispose of the device in the household waste. Disposal should be at an appropriate collection point

provided in your country.

13. Do not boil the probe.

14. Do not use thinner or benzene to clean the device.

15. Remove the battery if the device is not to be used for a long time.

16. If this device is used according to the operation instructions, periodic re-calibration is not required. If you still have

questions, contact the manufacturer listed on the carton.

17. The battery should not be charged or placed in extreme heat, as it may explode.

18. The thermometer contains small parts that can be swallowed by children, therefore never leave the thermometer

unattended.

Speciﬁcation

Temperature measurement range 34.0°C-42.2°C (93.2°F-108.0°F)

Accuracy ±0.2°C (0.4°F) between 35.0°C-42.2°C (95°F-108.0°F)

±0.3°C (0.5°F) outside these temperatures.

Operating temperature range 10°C–40°C (50°F -104°F)

RH≤95%; 700-1060 hPa

Storage and transportation temperature Temperature: -25°C-55°C (-13°F-131°F)

RH≤95%; 700-1060 hPa

Memory 9 measurements

Display resolution 0.1

Battery 3v, lithium CR2032

Weight (with battery) 55g

Size 12.0cm (L) x 3.5cm (W) x 2.8cm (H)

Probe covers 20

Auto shutdown 60 seconds.

Battery life 3000 consecutive measurements, or 1 year with 1-2

measurements per day

Safety classiﬁcation Type BF equipment

Clinical repeatability ±0.08°C (<1 year old)

±0.10°C (1 - 5 years old)

±0.07°C (> 5 years old)

IP classiﬁcation IP22. Protection against harmful ingress of water and particulate

matter

10 11

EMC guidance and manufacturer’s declaration

Guidance and manufacturer’s declaration-electromagnetic emissions

The Alvita Infrared Ear Thermometer is intended for use in the electromagnetic environment speciﬁed below.

The user of the Alvita Infrared Ear Thermometer should ensure that it is used in such an environment.

Emission Test Compliance Electromagnetic environment-guidance

RF emissions CISPR 11 Group 1 The Alvita Infrared Ear 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.

RF emissions CISPR 11 Class B The Alvita Infrared 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

Harmonic emissions

IEC 61000-3-2

Not applicable

Voltage ﬂuctuations/ﬂicker

emissions IEX 61000-3-3

Not applicable

Guidance and manufacturer’s declaration-electromagnetic immunity

The Alvita Infrared Ear Thermometer is intended for use in the electromagnetic environment speciﬁed below. The

customer or the user of the Alvita Infrared Ear Thermometer should ensure 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

3 Vrms

150KHz to

80Mhz

Not applicable Portable and mobile RF communication

equipment should be used no closer to

any part of the RA600 series, 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 80MHz to 800MHz

d = 2.3 √P 800MHz 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 metres (m).

Field strengths from ﬁxed RF transmitters,

as determined by an electromagnetic

site survey, (a) should be less then the

compliance level n each frequency range.

(b) interference may occur in the vicinity

of equipment marked with the following

symbol:

Radiated RF IEC

61000-4-3

3V/m

80mHz to

2.5 GHz

3 V/m

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption

and reﬂection from structure, 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 FM transmitters, an electromagnetic site survey

should be considered. If the measured ﬁeld strength in the location in which the Alvita Infrared Ear Thermometer is

used exceeds the applicable RF compliance level above, the Alvita Infrared 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 Alvita Infrared 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 Alvita Infrared Ear Thermometer is intended for use in the electromagnetic environment speciﬁed below.

The user of the Alvita Infrared Ear Thermometer should ensure that it is used in such an environment.

Immunity Test IEC 60601

Test Level

Compliance

level

Electromagnetic environment-guidance

Electrostatic discharge

(ESD) IEC 61000-4-2

± 6 kV contact

± 9 kV air

± 6 kV contact

± 9 kV air

Floors should be wood, concrete or

ceramic tile. If ﬂoors are covered with

synthetic material, the relative humidity

should be at least 30%.

Electrical fast transient/

burst IEC 61000-4-4

± 2kV for

power supply

lines

± 1kV for input/

output lines

Not applicable

Mains power quality should be that

of a typical commercial or hospital

environment.

Surge IEC 61000-4-5 ± 1kV line(s) to

line(s)

± 2kV line(s) to

earth

Not applicable

Mains power quality should be that

of a typical commercial or hospital

environment

Voltage Dips, short

interruptions and voltage

variations on power supply

input lines IEC 61000-4-11

<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

seconds

Not applicable

Mains power quality should be that

of a typical commercial or hospital

environment. If the user of the Alvita

Infrared Ear Thermometer requires

continued operations during power mains

interruptions, it is recommended that

the Alvita Infrared 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 The Alvita Infrared Ear Thermometer

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

12 13

Recommended separation distance between portable and mobile RF communications equipment and the Alvita

Infrared Ear Thermometer

The Alvita Infrared Ear Thermometer is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The user of the Alvita Infrared Ear Thermometer can help prevent electromagnetic

interference by maintaining a minimum distance between portable and mobile RF communications equipment

(transmitters) and the Alvita Infrared 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

150 kHz to 80 MHz /

d=1.2 √ P

80 MHz to 800 MHz /

d=1.2 √ P

800 MHz to 2,5 GHz /

d=2.3 √ P

0.01 N/A 0.12 0.23

0.1 N/A 0.38 0.73

1N/A 1.2 2.3

10 N/A 3.8 7.3

100 N/A 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in

metres (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 aected by absorption

and reﬂection from structures, objects and people.

WARNING: The symbol on this product means that it’s an electronic product and

following the European directive 2012/19/EU the electronic products have to be dispose

on your local recycling centre for safe treatment.

Warranty

This instrument is covered by a 2 year guarantee from the date of purchase. Batteries

and accessories are not covered by the guarantee. Opening or altering the instrument

invalidates the guarantee. The guarantee does not cover damage, accidents or non-

compliance with the instruction manual. Please contact your retailer.

Rossmax Swiss GmbH, Tramstrasse 16, CH-9442 Berneck, Switzerland

Alvita™UK, 43 Cox Lane, Chessington, Surrey KT9 1SN

Alvita™France, (tel. +33 1 40 80 19 80)

Alvita™Kundenservice Deutschland, Telefon 0800-1258482

Alvita™Italia, Numero verde 800-094242

Alvita™España, Av. Verge de Montserrat, 6 08820 El Prat de Llobregat, Barcelona, email: [email protected]

Alvita™Portugal, Rua Eng. Ferreira Dias, 728 – 3º Piso Sul – 4149-014 Porto (tel. 22 532 24 00)

0120

ALV4829/3

CNP 6301838

PIP Code 376-5690

Y-25°C l55°C

iwhRA600

m95%

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