Campi di prossimità
IEC 61000-4-3
da apparecchi di
comunicazione RF
wireless
Campi magnetici a
IEC 61000-4-8
frequenza nominale
di rete
Transitori elettrici veloci
IEC 61000-4-4
(burst)
Per porta di alimentazione di ingresso CA
linee elettriche CC o linee di ingresso/uscita del segnale con lunghezza
superiore a 3 m
Sovratensioni
IEC 61000-4-5
Disturbi condotti
IEC 61000-4-6
indotti da campi a
Per 1. porta di alimentazione di ingresso CA;
radiofrequenza
2. tutte le porte di alimentazione CC collegate in modo permanente a
cavi >3m
3. tutti i cavi collegati al paziente
4. SIP/SOP con lunghezza massima del cavo ≥ 3 m
Cali di tensione
IEC 61000-4-11
Interruzioni di tensione
IEC 61000-4-11
UT: tensione nominale, ad es. 25/30 cicli significa 25 cicli a 50Hz o 30 cicli a 60Hz
Distanze minime di separazione consigliate
Oggi, molti apparecchi RF wireless vengono utilizzati in diversi ambienti di assistenza sanitaria dove si
utilizzano già apparecchiature mediche e/o sistemi medici. Quando vengono utilizzati in prossimità di
apparecchiature mediche e/o sistemi medici, la sicurezza di base di tali apparecchiature mediche e/o dei
sistemi medici e le loro prestazioni essenziali possono essere compromesse. Questo dispositivo è stato
testato conforme al livello del test d'immunità riportato nella tabella sottostante e soddisfa i requisiti della
norma IEC 60601-1-2:2014. Il cliente e/o l'utente devono assicurarsi di mantenere una distanza minima
tra gli apparecchi di comunicazione RF wireless e il presente dispositivo, come specificato di seguito.
Frequenza
Banda
Assistenza
di prova
(MHz)
(MHz)
385
380-390
TETRA400
450
430-470
GRMS 460
FRS 460
710
704-787
Banda LTE
745
13, 17
780
810
800-960
GSM 800/900
870
TETRA 800,
930
iDEN 820,
CDMA 850,
LTE Banda 5
1720
1700-1990
GSM 1800;
1845
CDMA 1900;
1970
GSM 1900;
DECT; Banda
LTE 1, 3, 4, 25;
UMTS
2450
2400-2570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
Banda LTE 7
5240
5100-5800
WLAN
5500
802.11 a/n
5785
Smaltimento: Il prodotto non deve essere smaltito assieme agli altri rifiuti domestici. Gli utenti
devono provvedere allo smaltimento delle apparecchiature da rottamare portandole al luogo di
raccolta indicato per il riciclaggio delle apparecchiature elettriche ed elettroniche.
CONDIZIONI DI GARANZIA GIMA
Si applica la garanzia B2B standard Gima di 12 mesi.
DIGITAL THERMOMETER
Congratulations on your purchase of this p roduct. Please read the instructions carefully before using the
thermometer for the first 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 first. 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 flashing "°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 flashes. 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
flashing. 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 specified 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.
Vedere la tabella degli apparecchi di comuni-
cazione RF wireless nella sezione "Distanze
minime di separazione consigliate".
30 A/m; 50Hz o 60Hz
N/A
N/A
N/A
N/A
N/A
Modulazione
Potenza
Distanza
massima
(m)
(W)
Modulazione
1,8
0,3
impulso 18Hz
FM ± 5 kHz,
2
0,3
deviazione
1 kHz sine
Modulazione
0,2
0,3
impulsi 217Hz
Modulazione
2
0,3
impulso 18Hz
Modulazione
2
0,3
impulso 217Hz
Modulazione
2
0,3
impulso 217Hz
Modulazione
0,2
0,3
impulso 217Hz
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 fluctuate 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 fields, i.e. keep it away from any radio systems and mobile
phones.
Livello
Battery replacement
del test
The battery is empty and needs replacing when the "
d'immunità
of the LCD. Remove the battery cover and replace it with a battery (preferably non-mercury) of the same
(V/m)
type.
Please note:
27
the "- " sign up and " + " sign down.
Technical data
28
Type: maximum thermometer
Measurement range:(32.00~ 43.00)°C
Measurement accuracy:
9
+/- 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:
28
(-25~55)°C, ≤95%RH
Ambient temperature during use:
(5~35)°C, ≤80%RH
Min Scale: 0.01 °C
Battery type:
28
Alkaline battery, type LR41, 1.5V, service life minimum 100 hours under continuous operation.
Weight: Approx. 12g
Explanation of symbols
Battery check
28
WEEE disposal
Temperature under 32°C
Lo°C
9
Temperature over 42.9°C
HI°C
Stand by
Type BF applied part
Caution: read instructions
(warnings) carefully
ENGLISH
Keep away from sunlight
Keep in a cool, dry place
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 specifications 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 confirms 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 Notified body confirms
that this product
fulfills 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 defined 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
" or "
" battery symbol appears on the right
Manufacturer
Date of manufacture
Medical Device complies with
Directive 93/42/EEC
Product code
Lot number
IP22
Covering Protection rate
Temperature limit
Humidity limit
Direct current