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PROFESSIONAL MEDICAL PRODUCTS
TERMOMETRO AURICOLARE
IR EAR THERMOMETER
THERMOMETRE AURICOLAIRE
OHRENTHERMOMETER
TERMÓMETRO AURICULAR
TERMÔMETRO AURICULAR
ΘΕΡΜΟΜΕΤΡΟ ΑΥΤΙΟΥ
Model: TH889
25580
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[email protected] - [email protected]
www.gimaitaly.com
M25580-M-Rev.3-02.22
Made in China
IP22
0476
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Intended use
The ear thermometer is electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from ear
canal in people of all ages.
Intended operator: Have eight years of education, no maximum.
Thank you for purchasing the thermometer.
This thermometer is designed with an advanced infrared and ambient temperature
compensation technology for instantaneous
self-diagnosis and accurate temperature
measurements. Do not use this device for
Live & Dead decision or Safety related ap-
plications.
Please consult with doctor if you have health
concerns.
Operating Instructions
NOTE: The device must stay in stable ambient (room) temperature for 15 minutes before operating.
1. Gently squeeze the opposite ends of the thermometer to pull off the probe cap. Do not use force to
remove the cap.
2. Always use a new and undamaged probe cover. Make sure the ear canal is clean.
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.
3. Install Probe Cover
1) Place a new probe cover on the connection ring. (See Figure 1)
NOTE: Make sure to place the “Adhesive Side” of probe cover “Upward.”
2) Align the probe with the center of probe cover. Insert the probe into the probe cover on the connec-
tion ring. (See Figure 2)
3) Push the connection ring until the “Click” sound. This means the probe cover has been installed
successfully.
NOTE: If the probe cover did not connect rmly, the “ ” icon will ash on the LCD screen. Please
check the setting of the probe cover again.
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Figure 1 Figure 2
Proper installation of the probe cover and using the specic probe cover ensure accurate meas-
urements.
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4. Press “ON/MEM” button to power on. The thermometer is ready
for use after the ear icon stop ashing and two short beep sound.
5. Gently pull the ear back to straighten the ear canal and snugly po-
sition the probe into the ear canal, aiming towards the membrane of
the eardrum to obtain an accurate reading. (Fig.4-1)
6. Measuring the ear temperature: Use the index nger to trigger.
Press the “Scan” button until you hear a long beep. (Fig.4-2). After
each ear measurement, wait “ ” icon stop ashing to be ready for
Figure 4-1 Figure 4-2
next measurement.
7. Power off: This device will automatically shut down after 1 minute
pending to extend battery life.
NOTE
a. Before the measurement, please stay in a stable environment for 5mins and avoid the exercise, bath
for 30mins.
b. It is recommended that you measure 3 times with the same ear. If the 3 measurements are different,
select the highest temperature.
c. To avoid the risk of cross contamination, please clean the probe according to “Cleaning and Storage”
section after each use.
d. The “Clinical Bias” is -0.2 ~ -0.4°C.
e. The “Limits of Agreement” is 0.58.
f. The “Repeatability” is 0.17°C.
Fever Indication:
If the thermometer detects a body temperature ≥37.5°C (or 99.5°F), three short beep sound will follow
one long beep sound to warn the user for potential fever.
Switching between Fahrenheit (°F) and Celsius (°C):
In “Power Off” mode, press and hold the “SCAN” button, then press the “ON/MEM” 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.
Memory Function:
When in power on, press the “ON/MEM” button to see the temperature stored. The thermometer provides 9 sets memory for the body temperature.
Cleaning and Storage:
The probe is the most delicate part of the thermometer. Use with care when cleaning the lens to avoid
damage.
** The probe cover is disposable: throw it away and replace it after each use to ensure an ac-
curate reading and avoid cross contamination.
Storage temperature Range: It should be stored at room temperature between -20~+50°C, RH ≤85%
Keep the unit dry and away from any liquids and direct sunlight. The Probe should not submerge into
any liquids.
** If device is accidentally used without probe cover, clean the probe as follows:
a. Please use the cotton swab with 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 the device if damaged once it falls. If you can’t make sure of it,
please send the complete device to the nearest retailer 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.
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Changing the Battery:
This device is supplied with one lithium cell (CR2032 x 1).
1. Open the battery cover: Insert a pointed object into the battery cover pick hole. At the same time, use
thumb to remove battery cover. (See Figure 1)
2. Flip the battery out with a small screw driver (See Figure 2)
3. Insert the new battery under the metal hook on the left side and press the right side of the battery
down until you hear a “click”. (See Figure 3)
4. Replace the battery cover.
The positive (+) side Up and the negative (-) side pointed Down.
Figure 1 Figure 2 Figure 3
Specications:
- 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), ±0.3°C (0.5°F) for other range.
- This thermometer is an adjusted mode thermometer that 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: 149.1 x 42.5 x 54.9 mm
- Weight: 79.7 grams including battery
- Battery life: around 3,000 continuous readings.
- Product life: 4 years
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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.
NOTE: The thermometer is calibrated at the time of manufacture. If at any time you question the accuracy of temperature measurements, please contact the dealers or nearest service address.
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Throubleshooting
Error message Problem Solution
°C
Device stabilization in process.
Wait until stops ashing.
ENGLISH
Battery is low and no more
measurements are possible.
Measurement before device
stabilization.
The ambient temperature is not
within the range between 10°C
and 40°C (50°F ÷ 104°F).
Error 5 ÷ 9, the system is not
functioning properly.
°C
Temperature taken is higer than
42,2°C (108°F).
°C
Temperature taken is lower than
34°C (93,2°F).
°C
Device can not be powered on to
the ready stage.
Medical Device complies
with Directive 93/42/EEC
Caution: read instructions
(warnings) carefully
Replace the battery.
Wait until stops ashing.
Allow the thermometer to rest in a room
at least 15 minutes at room temp. (10°C
÷ 40°C, 50°F ÷ 104°F).
Unload the battery, wait for 1 minute and
repower it. If the message reappears,
contact the retailer for service.
Check the integrity of the probe
cover and take a new temperature
measurement.
Make sure the probe cover and the lens
are clean and take a new temperature
measurement.
Change with a new battery.
Symbols
Product code WEEE disposal
Lot number Keep away from sunlight
Follow instructions for use Manufacturer Keep in a cool, dry place
Type BF applied part
Date of manufacture
Covering Protection rate
IP22
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.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
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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
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 equipment.
RF emissions
CISPR 11
Class B The device 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 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
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
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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 xed RF transmitters, 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) 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 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 device 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
level
Electrostatic
discharge (ESD)
IEC 61000-4-2
contact ±8 Kv
air ±2, ±4, ±8,
±15 kv
Compliance
level
contact ±8 Kv
air ±2, ±4, ±8,
±15 Kv
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
(50/60 Hz) magnetic
eld IEC 61000-4-8
30 A/m
50 Hz or 60Hz
30 A/m
50 Hz or 60Hz
Power frequency magnetic elds
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
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
Separation distance according to frequency of transmitter m
150KHz to 80MHz
d = 1.2 √P
80MHz to 800MHz
d = 1.2 √P
800MHz to 2.7GHz
d = 2.3 √P
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 me-
ters (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.
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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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