Gima m25562 User manual

PROFESSIONAL MEDICAL PRODUCTS
• LCD (visore a cristalli liquidi)
• LCD • ÉCRAN LCD
• LCD • LCD • LCD
• Punta del termometro
• Thermometer tip
• Embout thermométrique
• Punta termométrica
• Ponta do termómetro
• Ακροφύσιο θερμομέτρου
• Sensore del termometro
• Thermometric sensor
• Capteur thermométrique
• Sensor termométrico
• Sensor termométrico
• Αισθητήρας θερμομέτρου
• 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

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. The Waterproof thermometers can be immersed in
liquid or lukewarm water for through cleaning and disinfection.
Summary of use specication
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 dened 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 benzene. Only clean with disinfectant.
• Do not immerse the Waterproof thermometers under water 15cm for longer than 30 minutes.
• The thermometer contains small parts (battery, battery compartment) which can be swallowed by chil-
dren. 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℃, 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
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)
Storage/transportation temperature: (-25~55)°C, ≤95%RH
Ambient temperature during use: (5~40)°C, ≤80%RH
Min Scale: 0.1°C
Atmospheric pressure 700~1060 hPa
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
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 electromag-
netic 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.
ENGLISH
DIGITAL THERMOMETER
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 “°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 42.9°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 considered 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 10 times, and the “°C” 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 “Meth-
ods 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 after 10 minutes.
Memory function
Switch the thermometer on, a short beep will sound. At the same time the thermometer runs a self-check
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 specied in order to ensure that a correct temper-
ature 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 2cm.
The usual measuring time is approximately 20 to 70 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 40 to 100 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 to 0.8°C 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 30 to 80 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.
Guidance and manufacture’s declaration – electromagnetic emissions
The device is suitable for use in the specied electromagnetic environment and it has meets the follow-
ing 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
or Battery is empty
WEEE disposal
Lo°C Temperature under 32°C
HI°C Temperature over 42.9°C
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
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
Direct current

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 equip-
ment.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
Recommended minimum separation distances
Nowadays, many RF wireless equipments have being used in various healthcare locations where med-
ical 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)
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 GMRS 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
Guidance and manufacture’s declaration – electromagnetic immunity
The device is suitable for use in the specied electromagnetic environment and it has meets the follow-
ing immunity test levels. Higher immunity levels may cause the device’s essential performance lost or
degraded.
Phenomenon Basic EMC standard
or test method Professional healthcare 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 RF
wireless communica-
tions equipment
IEC 61000-4-3 See the RF wireless communication equipment
table in “Recommended minimum separation dis-
tances
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

25562
M25562-M-Rev.0-06.21
IP22
0476
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
Made in China
95% 1060hPa
700hPa
55°C
-25°C 0%