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

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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
Probe cover
Temperature button
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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
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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.
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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
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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
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
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
Not applicable
Not applicable
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
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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.
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Rossmax Swiss GmbH, Tramstrasse 16, CH-9442 Berneck, Switzerland
Alvita™UK, 43 Cox Lane, Chessington, Surrey KT9 1SN
Alvita™France, (tel. [phone])
Alvita™Kundenservice Deutschland, Telefon [phone]
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. [phone])
0120
ALV4829/3
CNP 6301838
PIP Code 376-5690
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