alvita RA600 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 an infrared ear thermometer using an
infrared detector to detect body temperature in the ear canal for adults and children.
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
EN
• This thermometer has been designed to be used with the original probe covers from
Alvita. This is to prevent the sensitive probe tip from becoming blocked with wax
from ear.
• Use a new probe cover for each reading to ensure an accurate measurement and
prevent cross contamination.
• Ear wax can aect the measurement, you should clean the ear before measuring if
necessary. (Care should be taken when cleaning the ear.)
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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.
- The patient is the intended operator.
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
EN
20 spare Probe Covers
(the thermometer only works with a probe cover).
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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 (1) and back to
straighten the ear canal (2) 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.
Probe
Cover
Turn
Clockwise
to lock
1
2
EN
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Step 4
Press and hold the blue “Temperature” button for 3
seconds whilst gently pivoting the probe from side to
side within the ear. This allows you to measure the
temperature of the entire ear canal to find the highest
temperature.
Replace the probe cover after use, to ensure an accurate measurement
and avoid cross contamination.
Only use Alvita probe covers.
Step 5
After 3 seconds, a long beep will be heard. This is when the measurement can be read.
A further two beeps will sound to indicate that the thermometer is ready to take another
measurement.
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 replacing
the probe cover each time. If the 3 measurements dier, select the highest
temperature.
EN
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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.
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.
EN
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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.
For further information visit www.thinkalvita.co.uk
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).
EN
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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.
EN
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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 recharged 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.
19. Do not service or maintain the device whilst in use.
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.
EN
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Electromagnetic Compatibility Information
1. This Alvita Infrared Ear Thermometer needs to be installed and put into service in accordance with the information
provided in the user manual.
2. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of this device, including cables specified by
the manufacturer. Otherwise, degradation of the performance of this device could result.
If higher IMMUNITY TEST LEVELS than those specified in Table 9 are used, the minimum separation distance may
be lowered. Lower minimum separation distances shall be calculated using the equation specified in 8.10.
EN
Manufacturer’s declaration-electromagnetic immunity.
The Alvita Infrared Ear Thermometer is intended for use in the electromagnetic environment (for home healthcare)
specified below. The customer or the user of the Alvita Infrared Ear Thermometer should assure that is used in
such environment.
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic environment-guidance (for
home healthcare environment).
Conducted RF
IEC 61000-4-6
3 Vrms:
0,15 MHz – 80 MHz
6 Vrms: in ISM and
amateur radio bands
between
0,15 MHz and 80 MHz
80 % AM at 1 kHz
Not applicable
Not applicable
Portable and mobile RF communications
equipment should
be used no closer to any part of the
Alvita Infrared 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 80MHz to
800 MHz, d = 2,3 √P 800MHz to 2,7 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).
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 k
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 aected by absorption
and reflection from structures, objects and people.
More information on EMC compliance of the device may be obtained from Rossmax using the contacts shown in this
manual.
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