Gima 25608 User manual

PROFESSIONAL MEDICAL PRODUCTS
•Sensore del termometro
•Thermometric sensor
•Capteur thermométrique
•Sensor termométrico
•Sensor termométrico
•Αισθητήραςθερμομέτρου
•LCD (visore a cristalli liquidi) •LCD
•ÉCRAN LCD •LCD •LCD • LCD
•Pulsante ON/OFF
•ON/OFF Button
•Bouton ON/OFF
•Botón ON/OFF (inicio/detener)
•Botão ON/OFF
•ΠλήκτροON/OFF
•Scompartimento della batteria
•Battery compartment
•Compartiment à piles
•Compartimiento de las pilas
•Compartimento da pilha
•Κάλυμμαμπαταρίας
• Punta del termometro
•Thermometric tip
• Embout thermométrique
• Punta termométrica
• Ponta do termómetro
• Ακροφύσιοθερμομέτρου

ENGLISH
DIGITAL THERMOMETER
Congratulations on your purchase of this p roduct. 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.
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 “°C” display, the thermometer is now ready for use. If the ambient temperature is below 32 °C
then “Lo °C” will appear on the LCD and if it is more than 43 °C then “HI °C” will appear on the LCD.
During the reading, the current temperature is displayed continuously and the “°C” symbol ashes. The
measurement is completed when a constant temperature value has been reached. The temperature
value is consider ed constant when the temperature rises less than 0.1 °C within 16 seconds. As soon
as the constant temperature value is reached, a beep will sound four times, and the “°C” symbol will stop
ashing. The highest temperature measured appears on the LCD. However, please note that this thermo-
meter 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 measur ement is completed, please switch the ther-
mometer off by pressing the ON/OFF button. After the temperature has been displayed, the thermometer
will shut off automa tically after 10 minutes.
Memory function
Switch the thermometer off,then press the ON/OFF button for about 2 seconds.The last measured value
with “°C” will appear automatically on the LCD. This display is visible as long as the ON/OFF button is held
down. 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 specied in order to ensure that a correct tempera-
ture 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 to 1.5 °C 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 minu-
tes 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 to 0.8 °C
lower than the rectal temperature. To ensure that reading is as accurate as possible, place the thermo-
meter 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 guaranteed waterproof and can
therefor e be immersed in liquid or lukewarm water for through cleaning and disinfection.
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 water or disinfectant.
• Do not immerse the Waterproof thermometers under water 15cm for longer than 30 minutes.
• The thermometer contains small par ts (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.
• If the ambient temperatur e is over 35°C , 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 replace it with a battery (preferably non-mercury) of the same
type.
Please note:
the “- “ sign up and “ + “ sign down.
Technical data
Type: maximum thermometer
Measurement range:(32.00~ 43.00)°C
Measurement accuracy:
+/- 0.10 C(35.50 C~42.00°C)
+/-0.20 C(32.00 C~35.50 C, 42.00 C~43.00 C
Storage/transpor tation temperature:
(-25~55)°C, ≤95%RH
Ambient temperature during use:
(5~35)°C, ≤80%RH
Min Scale: 0.01 °C
Battery type:
Alkaline battery, type LR41, 1.5V, service life minimum 100 hours under continuous operation.
Weight: Approx. 12g
Explanation of symbols
Battery check Manufacturer
WEEE disposal Date of manufacture
Lo°C Temperature under 32°C
Medical Device complies with
Directive 93/42/EEC
HI°C Temperature over 42.9°C
Product code
Stand by Lot number
Type BF applied part
IP22
Covering Protection rate
Caution: read instructions
(warnings) carefully
Temperature limit
Keep away from sunlight Humidity limit
Keep in a cool, dry place Direct current
Consult instructions for use
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 specications of below
standard for:
ISO 80601-2-56-2017AMD.1:2018
EN 60601-1
EN 60601-1-11
EN 60601-1-2
The CE Marking conrms 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 Notied body conrms
that this product
fullls 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 dened 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 specied electromagnetic environment and
it has meets the following standard’s emission requirements.
Phenomenon Profession healthcare
facility environment Home healthcare environment
Home healthcare
environment
CISPR 11, Group 1,
Class A or B CISPR 11, Group 1, Class B
Harmonic distortion IEC 61000-3-2,
Class A or not applicable N/A
Voltage uctuations
and icker
IEC 61000-3-3
or not applicable N/A
Guidance and manufacture’s declaration – electromagnetic immunity
The device is suitable for use in the specied 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
or test method
Professional healthca-
re facility environment
Home healthcare
facility environment
Electrostatic
discharge
IEC 61000-4-2 +/- 8 kV contact
+/- 2 kV, +/- 4 kV, +/- 8 kV, +/- 15 kV air
Radiated RF
EM elds
IEC 61000-4-3 3V/m
80MHz-2.7GHz
80%AM at 1kHz or 2Hz
10V/m
80MHz-2.7GHz
80%AM at 1kHz or 2Hz
1kHz or 2Hz can be specied by
the manufacturer
Proximity elds
from RFwireless
communications equipment
IEC 61000-4-3 See the RF wireless communication equipment
table in “Recommended minimum
separation distances”.
Rated power
frequency magnetic elds
IEC 61000-4-8 30A/m; 50 Hz or 60Hz
Electric fast
transients bursts
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
Surges IEC 61000-4-5 N/A
Conducted disturbances
induced by RF elds
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
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 frequen-
cy (MHz)
Band
(MHz)
Service Modulation Maximum
power(W)
Distance
(m)
Immunity
test level
(V/m)
385 380-390 TETRA400 Pulse
modulation
18Hz
1,8 0,3 27
450 430-470 GRMS 460
FRS 460
FM ± 5 kHz
deviation
1 kHz sine
2 0,3 28
710
745
780
704-787 LTE Band
13, 17
Pulse
modulation
217Hz
0,2 0,3 9
810
870
930
800-960 GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation
18Hz
2 0,3 28
1720
1845
1970
1700-1990 GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
Pulse
modulation
217Hz
2 0,3 28
2450 2400-2570 Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Pulse
modulation
217Hz
2 0,3 28
5240
5500
5785
5100-5800 WLAN
802.11
a/n
Pulse
modulation
217Hz
0,2 0,3 9
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 electronic
equipment.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.

25608
M25608-M-Rev.5-06.23
IP22
0476
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
Made in China
55°C
-25°C
95°C
0°C