PROFESSIONAL MEDICAL PRODUCTS
• Sensore del termometro
• Thermometric sensor
• Capteur
thermométrique
• Sensor termométrico
• Sensor termométrico
• Thermometersensor
• Αισθητήρας θερμομέτρου
•
•
Punta del termometro
•
Thermometric tip
•
Embout thermométrique
•
Punta termométrica
•
Ponta do termómetro
•
Thermometerspitze
•
Ακρο θερμομέτρου
•
ATTENZIONE: il codice 25560 ha la scala di misura in °C, il codice 25561 ha la scala di misura
in °F
ATTENTION: code 25560 has the measurement scale in °C, code 25561 has the measurement
scale in °F
ATTENTION : le code
°F
en
ATENCIÓN: el código
de medición en
ATENÇÃO: o código
de medição em
ACHTUNG: Code
ΠΡΟΣΟΧΉ: ο κωδικός
κλίμακα μέτρησης σε
°F
°F
25560
25560
25560
25560
25560
°F
• Tasto ON/OFF
• ON/OFF Button
• ON/OFF Bouton
• ON/OFF Botón
• Botão ON/OFF
• ON/OFF-Taste
• Κουμπί ON/OFF
• ON/OFF
• LCD
• LCD
• Écran LCD
• LCD
• LCD
• LCD
• LCD
• LCD
a l’échelle de mesure en °C, le code
tiene la escala de medición en °C, el código
possui a escala de medição em °C, o código
hat die Messskala in °C, Code
έχει την κλίμακα μέτρησης σε °C, ο κωδικός 25561 έχει την
25561
• Vano batteria
• Battery compartment
• Compartiment batterie
• Batería compartimento
• Pilha compartimento
• Entnahme der Batterie
• Χώρος μπαταρίας
•
25561
25561
hat die Messskala in °F
25560
a l’échelle de mesure
25561
tiene la escala
25561
possui a escala
:
DIGITAL THERMOMETER (Not Waterproof)
ENGLISH
Note: The exterior of each model has a little difference.
Congratulations on your purchase of this product. Please read the instructions carefully before using
the thermometer for the rst time, and keep these in a safe place. This product is intended for the
measurement of human body temperature. this product is for home and hospital use, operator shall
be at least 11 years old and patient can be operator.
Operating Instructions
Before using, please disinfect the probe at rst. To switch on, press the ON/OFF button next to the
display; a short beep will sound, indicating that the thermometer is operational. At the same time the
thermometer runs a self-check test, during which all the digital segments appear on the LCD. When
the letters “Lo” and a ashing “℃” or “°F” display, the thermometer is now ready for use. If the ambient
temperature is below 32℃ or 89.6°F, then “Lo℃” or “Lo°F” or will appear on the LCD and if it is more
than 42.9℃ or 109.2°F, then “HI℃” or “Hi°F” will appear on the LCD.
During the reading, the current temperature is displayed continuously and the “℃” or “°F” symbol
ashes. The measurement is completed when a constant temperature value has been reached.
The temperature value is considered constant when the temperature rises less than 0.1℃ or 0.2°F
within 16 seconds. As soon as the constant temperature value is reached, a beep will sound ten
times, and the “℃” or “°F” symbol will stop ashing. The highest temperature measured appears on
the LCD. However, please note that this thermometer is a maximum thermometer, i.e. the displayed
temperature can increase slightly if measurement continues after the beep. This is particularly the
case with axillary measurements, should a temperature value be recorded which approximates the
core body temperature.
In this instance please note the description under “Methods of measuring temperature”. When the
measurement is completed, please switch the thermometer off by pressing the ON/OFF button. After
the temperature has been displayed, the thermometer will shut off automatically in 10 minutes.
Memory function
Switch the thermometer on, a short beep will sound. At the same time the thermometer runs a selfcheck test, during which all the digital segments appear on the LCD. After that the last measured value with “C” will appear automatically on the LCD for about 2 seconds. The reading is only over-written
when a new temperature value is recorded.
Methods of measuring temperature
It is important to remember that the body temperature reading depends on the site where it is measured. For this reason, the measurement site must always be specied in order to ensure that a correct
temperature reading is recorded.
In the rectum (rectal)
This is the most accurate method from a medical point of view, because it comes closest to the core
body temperature. The thermometer tip is inserted carefully into the rectum for a maximum of 2 cm.
The usual measuring time is approximately 40 to 60 seconds.
Under the arm (axillary)
Placing the thermometer in the armpit provides a measurement of surface temperature that can uctuate by around 0.5°C or 0.9℉ to 1.5°C or 2.5℉ from rectal temperature readings in adults. The usual
measuring time for this method is approximately 80 to 120 seconds. It should be noted, however, that
an exact reading cannot be obtained if, for example, the armpits have been allowed to cool. If this is
the case, we recommend extending the measuring time by around 5 minutes in order to obtain the
most precise possible reading that corresponds as closely as possible to the core body temperature.
In the mouth (oral)
There are different heat zones in the mouth. As a general rule, the oral temperature is 0.3°C or
0.5℉ to 0.8°C or 1.4℉ lower than the rectal temperature. To ensure that reading is as accurate as
possible, place the thermometer tip to the left or right of the root of the tongue. The thermometer tip
must have constant contact with the tissue during the reading and be placed under the tongue in one
of the two heat pockets at the back, keep the mouth closed during the reading and breathe evenly
through the nose. Do not eat or drink anything before the measurement. The usual measuring time
is approximately 50 to 70 seconds.
Note: We strongly recommend the rectal method as the most accurate method for identifying the
basal temperature, and advise you to extend the measuring time by 3 minutes after the beep.
Cleaning and disinfection
The best way to clean the thermometer tip is by applying a disinfectant (e.g. 70% medical alcohol)
with a damp cloth.
It shall be disinfected before each use. This thermometer is warned not waterproof and can not be
immersed in liquid or lukewarm water for through cleaning and disinfection.
Summary of use specication
This usability engineering process assesses and mitigated risks caused by usability problems associated with correct use and use errors, it shows the digital thermometer is complied with and
acceptance criteria documented in the usability validation plan have been met, then the residual risk
as dened in ISO14971, associated with usability of a medical device are acceptable.
Safety precautions
• Do not allow the device to come into contact with hot water.
• Do not expose to high temperatures or direct sunlight.
• Do not drop the thermometer. It is neither shock-proof nor impact-resistant.
• Do not modify this device without the authorization of the manufacturer.
• Do not bend or open the device (except the battery compartment).
• Do not clean with thinners, petrol or benzenel. Only clean with disinfectant.
• Do not immerse the thermometers in liquid.
• The thermometer contains small parts (battery, battery compartment) which can be swallowed by
children. For this reason, do not leave the thermometer unattended in the hands of children.
• Avoid bending the thermometer tip which contact patient with stainless steel cover.
• If the ambient temperature is over 40°C (104℉) dip the thermometer tip in cold water for approx. 5
to 10 seconds prior to measuring the temperature.
• Persistent fever, in particular in children, has to be treated by a doctor please get in touch with your
doctor!
• Do not use near strong electromagnetic elds, i.e. keep it away from any radio systems and mobile
phones.
Battery replacement
The battery is empty and needs replacing when the “ ” or “ ” battery symbol appears on
the right of the LCD. Remove the battery cover and remove the battery by toothpick, replace it with a
battery(preferably non mercury) of the same type.
Please note: the “ + ” sign up and “ - ” sign down.
We advise you to remove the batteries if the device is not going to be used for a longer period of time.
Technical data
Type: maximum thermometer
Measurement range: (32.0~42.9)°C - (89,6~109,2)°F
Measurement accuracy: +/-0.1°C (35.5°C~42.0°C), +/-0.2°C (32.0°C~35.5°C, 42.0°C~42.9°C)
+/-0.2℉ (95.9℉~107.6℉), +/-0.4℉ (89.6℉~95.9℉, 107.6℉~109.2℉)
Storage/transportation temperature: (-25~55)°C, (-13~131)℉ ≤95% UR
Ambient temperature during use: (5~40)°C, (41~104)℉ ≤80% UR
Min Scale: 0.1°C - 0.1°F
Atmospheric pressure:700~1060hPa
Mode of operation of the clinical thermometer: direct mode
Transient response time: 12s
Battery type: Alkaline battery, type LR41, 1.5V, service life minimum 100 hours under continuous
operation.
Weight: Approx. 10g
Shelf life: 3 years
Explanation of symbols
Battery check
WEEE disposal
Lo°C-Lo°F
HI°C-HI°F
Legal requirements and guidelines
This product complies with the European Directive for Medical Device 93/42/EEC and carries the CE
mark, the device also complies with the specications of below standard for:
ISO 80601-2-56:2017/AMD 1:2018
EN 60601-1
EN 60601-1-11
EN 60601-1-2
The CE Marking conrms that this is a medical device with a measuring function in the sense of the
medical device Act which has undergone a conformity assessment procedure. A Notied body conrms that this product fullls all the appropriate statutory regulations
Calibration check
This thermometer is initially calibrated at the time of manufacture. If this thermometer is used according to the operation instruction, periodic re-adjustment is not required.
The calibration check has to be carried out immediately, if there are indications that the product
does not keep the dened error limits or the calibration properties could have been affected by an
intervention or by any other means.
Please also observe any national statutory regulations. The calibration check can be carried out by
the competent authorities or by authorised service providers.
A test instruction for calibration check can be provided to the relevant authorities and authorised
services providers on request.
ELECTROMAGNETIC COMPATIBILITY INFORMATION
This device is suitable for home healthcare environment and professional healthcare facility environment
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.
The essential performance is the digital thermometer can offer the temperature measurement.
Do not use mobile (cellular) telephones and other devices, which generate strong electrical or electromagnetic elds, near the medical device. This may result in incorrect operation of the unit and
create a potentially unsafe situation. Recommendation is to keep a minimum distance of 30cm.
Verify correct operation of the device in case the distance is shorter.
Guidance and manufacture’s declaration – electromagnetic emissions
The device is suitable for use in the specied electromagnetic environment and it has meets the
following standard’s emission requirements
Phenomenon Profession healthcare
Home healthcare
environment
Harmonic distortion IEC 61000-3-2, Class A
Voltage uctuations
and icker
Temperature under 32°C
(89.6℉)
Temperature over 42.9°C
(109.2℉)
Stand by
Type BF applied part
Caution: read instructions
(warnings) carefully
Keep away from sunlight
Keep in a cool, dry place
Consult instructions for use
facility environment
CISPR 11, Group 1,
Class A or B
or not applicable
IEC 61000-3-3
or not applicable
Manufacturer
Date of manufacture
Medical Device complies with
Directive 93/42/EEC
Product code
Lot number
IP22
Covering Protection rate
Temperature limit
Atmospheric pressure limit
Humidity limit
Home healthcare environment
CISPR 11, Group 1, Class B
N/A
N/A
Voltage dips IEC 61000-4-11 N/A
Voltage interruptions IEC 61000-4-11 N/A
UT: rated voltage(s); E.g. 25/30 cycles means 25 cycles at 50Hz or 30 cycles at 60Hz
Recommended minimum separation distances
Nowadays, many RF wireless equipments have being used in various healthcare locations where
medical equipment and/or systems are used. When they are used in close proximity to medical
equipment and/or systems, the medical equipment and/or systems’ basic safety and essential performance may be affected. This device has been tested with the immunity test level in the below
table and meet the related requirements of IEC 60601-1-2:2014. The customer and/or user should
help keep a minimum distance between RF wireless communications equipment and this device
as recommended below.
Test
frequency
(MHz)
385 380-390 TETRA400 Pulse modulation
450 430-470 GMRS 460
710
745
780
810
870
930
1720
1845
1970
2450 2400-2750 Bluetooth,
5240
5500
5785
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
Band
(MHz)
707-787 LTE Band
800-960 GSM 800/900
1700-1990 GSM 1800;
5100-5800 WLAN 802.11
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.
Service Modulation Maxi-
18Hz
FRS 460
13, 17
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
WLAN, 802.11
b/g/n, RFID
2450,
LTE Band 7
a/n
FM ± 5 kHz
deviation
1 kHz sine
Pulse modulation
217Hz
Pulse modulation
18Hz
Pulse modulation
217Hz
Pulse modulation
217Hz
Pulse modulation
217Hz
mum
power
W)
1,8 0,3 27
2 0,3 28
0,2 0,3 9
2 0,3 28
2 0,3 28
2 0,3 28
0,2 0,3 9
Distance
(m)
Immunity
test level
(V/m)
Guidance and manufacture’s declaration – electromagnetic immunity
The device is suitable for use in the specied electromagnetic environment and it has meets the
following immunity test levels. Higher immunity levels may cause the device’s essential performance lost or degraded.
Phenomenon Basic EMC standard
Electrostatic discharge IEC 61000-4-2 +/- 8 kV contact
Radiated RF EM elds IEC 61000-4-3 3V/m
Proximity elds from
RF wireless communi-
cations equipment
Rated power
frequency
magnetic elds
Electric fast
transients bursts
Surges IEC 61000-4-5 N/A
Conducted
disturbances
induced by
RF elds
or test method
IEC 61000-4-3 See the RF wireless communication equipment
IEC 61000-4-8 30A/m; 50 Hz or 60Hz
IEC 61000-4-4 N/A
For input a.c. power port
d.c. power lines or signal input/output lines whose length exceeding 3m
IEC 61000-4-6 N/A
For 1. input a.c. power port;
2. all d.c. power ports connected permanently to cables >3m
3. all patient-coupled cables
4. SIP/SOP whose maximum cable length ≥ 3m
Professional
healthcare facility
environment
+/- 2 kV, +/- 4 kV, +/- 8 kV, +/- 15 kV air
80MHz-2.7GHz
80%AM at 1kHz or
2Hz
1kHz or 2Hz can be specied by the manufac-
turer
table in “Recommended minimum separation
distances
Home healthcare
facility environment
10V/m
80MHz-2.7GHz
80%AM at 1kHz or
2Hz
M25560-M-Rev.3-05.21
25560 - 25561
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
Made in China
IP22
-25°C
55°C
0%
95% 1060hPa
700hPa
0476
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