Gima 25580 User manual

Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
TERMOMETRO AURICOLARE
IR EAR THERMOMETER
THERMOMETRE AURICOLAIRE
OHRENTHERMOMETER
TERMÓMETRO AURICULAR
TERMÔMETRO AURICULAR
ΘΕΡΜΟΜΕΤΡΟ ΑΥΤΙΟΥ
M25580-M-Rev.1-03.19
PROFESSIONAL MEDICAL PRODUCTS
Gima S.p.A.
Via Marconi, 1
20060 Gessate (MI) Italy
Made in China
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.
ACHTUNG: Die Bediener müssen vorher dieses Handbuch
gelesen und verstanden haben, bevor sie das Produkt benutzen.
ATENCIÓN: Los operadores tienen que leer y entender
completamente este manual antes de utilizar el producto.
ATENÇÃO: Os operadores devem ler e entender
completamente este manual antes de usar o produto.
ΠΡΟΣΟΧΗ: Οι χειριστές αυτού του προϊόντος πρέπει να διαβάσουν και να
καταλάβουν πλήρως τις οδηγίες του εγχειριδίου πριν από την χρήση του.
25580 0476
Manuale d’uso - User manual
Manuel de l’utilisateur - Gebrauchsanweisung
Guía de Uso - Guia para utilização
Οδηγίες χρήσης
IP22

9ENGLISH
Intended use
The infrared ear thermometer measures the
infrared heat generated by the eardrum and
surrounding tissue to reect patient’s body
temperature.
Intended operator: At least 11 years old (5
years intensive reading experience), no max-
imum.
Thank you for purchasing the thermometer.
This thermometer is designed with an ad-
vanced 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.
Figure 1 Figure 2
Proper installation of the probe cover and using the specic probe cover ensure accurate meas-
urements.

10
ENGLISH
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
next measurement.
7. Power off: This device will automatically shut down after 1 minute
pending to extend battery life.
NOTA
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 pro-
vides 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.
Figure 4-1 Figure 4-2

11 ENGLISH
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
Specications:
- 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(Safe-
ty) 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 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
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 accu-
racy of temperature measurements, please contact the dealers or nearest service address.

12
Throubleshooting
Error message Problem Solution
Device stabilization in process. Wait until stops ashing.
Battery is low and no more
measurements are possible. Replace the battery.
Measurement before device
stabilization. Wait until stops ashing.
The ambient temperature is not
within the range between 10°C
and 40°C (50°F ÷ 104°F).
Allow the thermometer to rest in a room
at least 15 minutes at room temp. (10°C
÷ 40°C, 50°F ÷ 104°F).
Error 5 ÷ 9, the system is not
functioning properly. Unload the battery, wait for 1 minute and repower it. If the message reappears,
contact the retailer for service.
Temperature taken is higer than
42,2°C (108°F). Check the integrity of the probe cover and take a new temperature
measurement.
Temperature taken is lower than
34°C (93,2°F). Make sure the probe cover and the lens are clean and take a new temperature
measurement.
Device can not be powered on to
the ready stage. Change with a new battery.
°C
°C
°C
°C
Symbols
Product complies with European
Directive Product code WEEE
Read instructions carefully Lot number
(see box / package) Keep away from sunlight
Please read instructions carefully Manufacturer Keep in a cool, dry place
Type BF applied part Date of manufacture
IP22
Impermeability index
ENGLISH

13
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 specic recycling point for electric and electro-
nic 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 de-
fected 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.
ENGLISH

38
ΧΩΝΕΥΣΗ: Το προιόν δεν πρέπει να πεταχτεί μαζύ με άλλα απορρύματα του σπιτιού. Οι
χρήστες πρέπει να φροντίσουν για την χώνευση των συσκευών μεταφέροντάς τες σε
ειδικούς τόπους διαχωρισμού για την ανακύκλωση ηλεκτρικών και ηλεκτρονικών συ-
σκευών. Για περισότερες πληροφορείες στούς χώρους συγκέντρωσης, επικοινωνήστε
με την υπηρεσία του δήμου παραμονής σας, το τμήμα χώνευσης τοπικών απορυμμάτων
ή το κατάστημα απο το οποίο αγοράσατε το προιόν. Σε περίπτωση λανθασμένης χώνευ-
σης υπάρχει κίνδυνος εφαρμογής κυρώσεων βάσει των κρατικών νόμων.
ΣΥΝΘΗΚΕΣ ΕΓΓΥΗΣΗΣ GIMA
Συγχαίρουμε μαζί σας που αγοράσατε ένα δικό μας προϊόν. Αυτό το προϊόν ανταποκρίνεται
στα υψηλά ποιοτικά πρότυπα τόσο των υλικών όσο και της κατασκευής. Η εγγύηση ισχύει για
12 μήνες από την ημερομηνία απόκτησης του GIMA. Κατά την διάρκεια ισχύος της εγγύησης
θα φροντίσουμε για την επιδιόρθωση και / ή την δωρεάν αντικατάσταση όλων των υλικών που
θα παρουσιάσουν βλάβη λόγω αποδειγμένου προβλήματος κατασκευής, με εξαίρεση τα εργα-
τικά έξοδα ή έξοδα μετακίνησης, μεταφορές και συσκευασίες. Εξαιρούνται της εγγύησης όλα
τα αναλώσιμα υλικά. Η αντικατάσταση ή επιδιόρθωση που γίνεται κατά την περίοδο εγγύησης
δεν έχουν σαν αποτέλεσμα την επιμήκυνση του χρόνου εγγύησης. Η εγγύηση δεν ισχύει σε
περίπτωση που: η επιδιόρθωση γίνεται από προσωπικό όχι εγκεκριμένο και με ανταλλακτικά όχι
αυθεντικά, ζημιές ή ελαττώματα που προκλήθηκαν από αμέλεια, χτυπήματα ή κακή χρήση. Η
GIMA δεν ευθύνεται για κακή λειτουργία σε ηλεκτρονικές συσκευές ή software που προέρχονται
από εξωτερικούς παράγοντες όπως: ανεβοκατεβάσματα ηλεκτρικής τάσης, ηλεκτρομαγνητικά
πεδία, ραδιοφωνικές παρεμβολές, κ.λ.π.. Η εγγύηση παύει να έχει ισχή εάν δεν τηρηθούν οι ως
άνω κανόνες και εάν ο αριθμός μητρώου ( εάν υπάρχει ) έχει απομακρυνθεί, σβηστεί ή αλλοιω-
θεί. Τα προϊόντα που θεωρούνται με βλάβη πρέπει να αντικατασταθούν αποκλειστικά και μόνον
από τον μεταπωλητή από τον οποίο αγοράστηκαν.
Αποστολή εμπορευμάτων κατευθείαν στην εταιρεία GIMA θα επιστραφούν.
ΕΛΛΗΝΙΚΆ

39
Guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environment specied 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 equi-
pment.
RF emissions CISPR 11 Class B The device is suitable for use in all establishments, in-
cluding domestic establishments and those directly con-
nected 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 specied 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 Compliance Electromagnetic environment – guidance
Radiated RF
IEC 61000-4-3 10 V/m 80 MHz to 2.7 GHz
80% AM at 1KHz
10 V/m
80 MHz to 2.7 GHz
80% AM at 1KHz
Recommended separation distance
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 dis the recommended separation
distance in meters (m).
Field strengths from xed RF transmit-
ters, as determined by an electroma-
gnetic site survey,ashould 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 reection from structures, objects and people.
aField 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.

40
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specied 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 Compliance level Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
contact ±8 Kv
air ±2, ±4, ±8,
±15 kv
contact ±8 Kv
air ±2, ±4, ±8,
±15 Kv
Floors should be wood, concrete or
ceramic tile.
If oors are covered with synthetic ma-
terial, 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 equi-
pment 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 2.5GHz
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 meters (m) can be estimated using the equation applicable to the frequency of the tran-
smitter, 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 reection from structures, objects and people.