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Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[email protected] - [email protected]
PROFESSIONAL MEDICAL PRODUCTS
www.gimaitaly.com
TERMOMETRO AURICOLARE A RAGGI INFRAROSSI
PROFESSIONALE
PROFESSIONAL INFRA-RED EAR THERMOMETER
THERMOMÈTRE AURICULAIRE À RAYONS
INFRAROUGES PROFESSIONNEL
TERMÓMETRO INFRARROJO DE OÍDO
PROFESIONAL
Manuale d’uso - User manual
Manuel de l’utilisateur - Guía de Uso
ATTENZIONE: Gli operatori devono leggere
e capire completamente questo manuale
prima di utilizzare il prodotto.
ATTENTION: The operators must carefully
read and completely understand the present
manual before using the product.
AVIS: Les opérateurs doivent lire et bien
comprendre ce manuel avant d’utiliser le produit.
ATENCIÓN: Los operadores tienen que leer y entender
completamente este manual antes de utilizar el producto.
25575 / THP59J
Radiant Innovation Inc.
1F, No.3, Industrial East 9th Road,
Science-Based Industrial Park, HsinChu, Taiwan 300
Medical Technology Promedt Consulting GmbH
Altenhofstrasse 80, D-66386 St. Ingbert, Germany
1639
IP22
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Intended use: The infrared ear thermometer measures the infrared heat generated by the
eardrum and surrounding tissue to reect patient’s body temperature.
Operating Instructions
Temperature taking
Place the Probe Cover
1. Align the the probe with the center of the
probe cover.
Make sure to place the “Adhesive Side” of
probe cover “Upward.”
2. Insert the probe into the probe cover on the
probe cover loader until you feel a “click”.
That means the probe cover has been
connected rmly.
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1.Proper installation of the probe cover and using the specic probe cover ensure
accurate measurements.
2. Warning: Choking from swallowing small parts and batteries by children or pets is
possible, please keep small parts and batteries at places where children and pets
can’t reach.
If the probe cover did not install well, will
ash on the LCD screen and can’t take the ear
temperature (will hear 4 beep sounds without
reading shown on the LCD when measuring).
Please check the setting of the probe cover again.
Power ON
1. Press “ON/MEM” button
2. See the icon
two beep sounds
on the LCD and hear
1 2
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Taking Ear temperature
Gently pull the ear back to straighten the ear
canal and snugly position the probe into the
ear canal, aiming towards the membrane of the
eardrum to obtain an accurate reading.
• For children under 2 years old
Pull the ear straight back.
• For children over 2 years old and adults
Pull the ear straight up and back.
Measuring
Press the “Scan” button for 1 second until you
hear a long beep sound. The measurement
is completed. You can read the result from
LCD. After two short beeps are heard, the
icon stops ashing to be ready for next
measurement.
Fever Indication:
If the thermometer detects a body temperature
≥37.5°C (99.5°F), three short beep sound will
follow one long beep sound to warn the user
for potential fever.
Power Off
Automatically shut down after 1 minute pending to extend battery life.
Attentions
a.The device must stay in stable ambient (room) temperature for 15 minutes before
operating.
b.Before the measurement, please stay in a stable environment for 5mins and avoid the
exercise, bath for 30mins.
c.It is recommended that you measure the same ear for 3 times. If the 3 measurements
are different, select the highest temperature.
d.The thermometer has been designed for practical use. It’s not meant to replace a
visit to the doctor. Please also remember to compare the measurement result to your
regular body temperature. Please consult with doctor if you have health concerns.
Press “Scan” button
NO OK
> 2 years0-2 years
Other Functions
Memory Locations (25 sets)
When power on, press the “ON/MEM” button to see
the temperature records with icon.
To change the LCD from °C to °F:
In “Power Off” mode, press and hold the “SCAN” button, then
press the “ON/M EM” button for 3 seconds, icon “°C” will be switched
to icon “°F”. You can also use the same process to change the LCD
display from °F to °C.
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Specications
• Temperature measurement range: 34~42.2°C (93.2~108°F)
• Operating temperature range: 10~40°C (50~104°F), 15%~85% RH
• Storage temperature range: It should be stored at room temperature between -20~+50°C,
RH ≤85%
Transportation temperature shall be less than 70°C, RH ≤95%
• Atmospheric pressure: 800~1013 hPa
• Comply with ASTM E1965-98, EN ISO 80601-2-56, IEC/EN60601-1-2(EMC),
IEC/EN60601-1(Safety) standards, ISO10993, RoHS.
• Accuracy: ±0.2°C (0.4°F) within 35~42°C (95~107.6°F)(Ambient Temp.:15~35°C),
±0.3°C (0.5°F) for other range.
• Fever indication & Memory, °C / °F Switch function
• Battery: one lithium cell battery (CR2032 x 1pcs).
• Battery life: around 3,000 continuous readings.
• Expected Service Life: 4 years
• This thermometer converts the ear temperature to display its “oral equivalent.” (according
to the result of the clinical evaluation to get the offset value)
• Enclosure Rating: IP22
• Dimensions: 144.8 x 48.5 x 39.8 mm
• Weight: 68.8 grams including battery
The device should not submerge into any liquids and expose it to direct moisture. There
is no gender and age limitation for using infrared thermometer. This is not an AP or
APG product
Normal body temperature
Normal body temperature is a range that will uctuate throughout the day. The normal range
for adult body temperature is typically considered to be 36.1 to 37.8°C (97 to 100°F). The
body temperature varies by age, person, gender, time of day, position of body, and is usually
highest in the evening. It can be affected by activity, emotion, clothing, medications, ambient
conditions, hormones and other factors. Normal temperature will also be different depending
on the place on the body at which the temperature is taken, with rectal or ear temperature
readings generally being higher than oral temperature readings, and armpit temperature
readings generally lower than oral readings.
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Temperature variations affected by age:
Young High
0~2 years: 36.4°C (97.5°F) ~ 38.0°C (100.4°F)
Age
Old Low
The “Clinical Bias” is -0.2 ~ -0.4°C.
The “Limits of Agreement” is 0.49.
The “Repeatability” is 0.14°C.
3~10 years: 36.1°C (97.0°F) ~ 37.8°C (100.0°F)
11~65 years: 35.9°C (96.6°F) ~ 37.6°C (99.7°F)
>65 years: 35.8°C (96.4°F) ~ 37.5°C (99.5°F)
Temp.
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Important Notes
Cleaning and storage
The probe is the most delicate part of the thermometer. Use with care when cleaning the
lens to avoid damage.
** Replace the probe cover after each use to ensure an accurate
reading and avoid cross contamination.
a. Storage temperature range: It should be stored at room temperature
between -20~+50°C, RH ≤85%
b. Transportation temperature shall be less than 70°C, RH ≤95%
c. Keep the unit dry and away from any liquids and direct sunlight.
d. The Probe should not be submerge into liquids
** If device is accidentally used without probe cover, clean the probe
as follows:
a. After the measurement, please use the cotton swab with the Alcohol
(70% concentration) to clean the lens( on the inside of the probe).
b. Allow the probe to fully dry for at least 1 minute.
Note: Please check if the device is damaged once it drops.
If you can’t make sure of it, please send the complete device to your
local dealer for recalibration.
Holding the thermometer too long may cause a higher ambient
temperature reading of the probe. This could make the body temperature
measurement lower than usual.
Battery replacement
ENGLISH
This device is supplied with one lithium cell CR2032 x 1.
1. Open the battery cover: Insert a pointed object into battery cover pick hole. At the same
time, use thumb to push battery cover out.
2. Hold the device and ip the battery out with a small screwdriver.
3. Insert the new battery under the metal hook on the left side (1) and press the right side (2)
of the battery down until you hear a “Click”.
4. Replace the battery cover
The positive (+) side up and the negative (-) side pointed down.
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Trouble shooting
Error Message Problem Solution
The probe cover has not been
installed well. will ash on the
LCD screen and can’t take the
ear temperature
Error 5~9, the system is not
functioning properly.
Measurement before device
stabilization.
The ambient temperature is not
within the range between 10°C
and 40°C (50°F ~104°F).
Temperature taken is higher than
+42.2°C (108°F)
Temperature taken is lower than
+34°C (93.2°F)
Device cannot be powered on to
the ready stage.
Please check the setting of the
probe cover again.
(Refer to the section of “Place
the Probe Cover” )
Unload the battery, wait for 1
minute and repower it. If the
message reappears, contact
the retailer for service.
Wait until all the icons stops
ashing.
Allow the thermometer to
rest in a room for at least 15
minutes at room temperature:
10°C and 40°C (50°F ~104°F).
Check the integrity of the
probe cover and take a new
temperature measurement.
Make sure the probe cover
is clean and take a new
temperature measurement.
Change with a new battery.
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Disposal: The product must not be disposed of along with other domestic waste.
The users must dispose of this equipment by bringing it to a specic recycling point
for electric and electronic equipment.
For further information on recycling points contact the local authorities, the local
recycling center or the shop where the product was purchased. If the equipment is
not disposed of correctly, nes or penalties may be applied in accordance with the
national legislation and regulations.
GIMA WARRANTY CONDITIONS
Congratulations for purchasing a GIMA product.
This product meets high qualitative standards both as regards the material and the production.
The warranty is valid for 12 months from the date of supply of GIMA.
During the period of validity of the warranty, GIMA will repair and/or replace free of charge all
the defected parts due to production reasons. Labor costs and personnel traveling expenses
and packaging not included.
All components subject to wear are not included in the warranty.
The repair or replacement performed during the warranty period shall not extend the warranty.
The warranty is void in the following cases: repairs performed by unauthorized personnel or
with non-original spare parts, defects caused by negligence or incorrect use.
GIMA cannot be held responsible for malfunctioning on electronic devices or software due
to outside agents such as: voltage changes, electro-magnetic elds, radio interferences, etc.
The warranty is void if the above regulations are not observed and if the serial code (if available)
has been removed, cancelled or changed.
The defected products must be returned only to the dealer the product was purchased from.
Products sent to GIMA will be rejected.
Symbols
Medical Device complies
with Directive 93/42/EEC
Caution: read instructions
(warnings) carefully
Follow instructions for use Manufacturer
Keep away from sunlight
Product code WEEE disposal
Type BF applied part IP22 Covering Protection rate
Keep in a cool,
dry place
Authorized representative in
the European community
Lot number
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Guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environment specied below. The customer or
the user of the device should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
RF emissions CISPR 11 Class B The device is suitable for use in all establishments, in-
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specied below. The customer or
the user of the device should assure that it is used in such an environment.
Immunity test IEC 60601 test
level
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2.7 GHz
80% AM at 1KHz
Group 1 The device 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 equi-
pment.
cluding domestic establishments and those directly con-
nected to the public low-voltage power supply network
that supplies buildings used for domestic purposes
Compliance Electromagnetic environment –
guidance
10 V/m
80 MHz to 2.7 GHz
Recommended separation distance
80% AM at 1KHz
d = 1.2 √P
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.7 GHz
Where P is the maximum output power
rating of the transmitter in watts (W) ac-
cording to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from xed RF transmit-
ters, as determined by an electromagnetic site survey,
a
should be less than
the compliance level in each frequency
range.
Interference may occur
in the vicinity of equipment
marked with the following
symbol:
NOTA 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTA 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reection from structures, objects and people.
a Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telepho-
nes 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 xed RF
transmitters, an electromagnetic site survey should be considered. If the measured eld strength in
the location in which the device is used exceeds the applicable RF compliance level above, the de-
vice should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the device.
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Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specied below. The customer or
the user of the device should assure that it is used in such an environment.
Immunity test IEC 60601 test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Power frequency
(50/60 Hz) magnetic
eld IEC 61000-4-8
Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEM
The device is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the device can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the device as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum
output power of
transmitter W
0.01 N/A 0.12 0.23
0.1 N/A 0.38 0.73
1 N/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 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 reection from structures, objects and people.
level
contact ±8 Kv
air ±2, ±4, ±8,
±15 kv
30 A/m
50 Hz or 60Hz
Separation distance according to frequency of transmitter m
150KHz to 80MHz
d = 1.2 √P
Compliance
level
contact ±8 Kv
air ±2, ±4, ±8,
±15 Kv
30 A/m
50 Hz or 60Hz
80MHz to 800MHz
d = 1.2 √P
Electromagnetic environment guidance
Floors should be wood, concrete or
ceramic tile.
If oors are covered with synthetic material, the relative humidity should be
at least 30 %.
Power frequency magnetic elds
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
800MHz to 2.7GHz
d = 2.3 √P
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Manufacturer’s declaration-electromagnetic immunity
Test specications for ENCLOSURE PORT IMMUNITY to RF wireless communications equip-
ment
The device is intended for use in the electromagnetic environment (for home healthcare) specied
below. The customer or the user of the device should assure that it is used in such an environment
Test frequency
(MHz)
385 380 – 390 TETRA 400 Pulse
450 430 – 470 GMRS 460,
710 704 – 787 LTE Band
745
780
810 800 – 960 GSM 800/900,
870
930
1 720 1700 –
1 845
1 970
2 450 2400 –
5 240 5100 –
5 500
5 785
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT
or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual
modulation, it would be worst case.
Band
(MHz)
1990
2570
5800
a)
a)
Service
FRS 460
13, 17
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
WLAN
802.11 a/n
Modulation b)Maximum
modulation b)
18 Hz
FM c) ±5 kHz
deviation 1 kHz
sine
Pulse
modulation b)
217 Hz
Pulse
modulation b)
18 Hz
Pulse
modulation b)
217 Hz
Pulse
modulation b)
217 Hz
Pulse
modulation b)
217 Hz
power (W)
1,8 0,3 27 27
2 0,3 28 28
0,2 0,3 9 9
2 0,3 28 28
2 0,3 28 28
2 0,3 28 28
0,2 0,3 9 9
Distance
(m)
IMMUNITY
TEST LEVEL
(V/m)
Compliance
LEVEL (V/m)
(for home
healthcare)
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