Gima 25560 Guia De Inicio Rapido página 2

Indicazioni e dichiarazione del costruttore - emissioni elettromagnetiche
Il dispositivo è adatto per l'uso nell'ambiente elettromagnetico specificato e soddisfa i requisiti di
emissione della seguente norma.
Problema Ambiente sanitario
professionale
Ambiente sanitario CISPR 11, Gruppo 1,
domestico Classe A o B
Distorsione armonica IEC 61000-3-2, Classe A
o non applicabile
Fluttuazioni di tensio- IEC 61000-3-3
ne e sfarfallii o non applicabile
Guida e dichiarazione del produttore e linee guida – immunità elettromagnetica
Il dispositivo è adatto per l'uso nell'ambiente elettromagnetico specificato e soddisfa i livelli dei
seguenti test d'immunità. Livelli di immunità più elevati possono causare la perdita o il degrado
delle prestazioni essenziali del dispositivo.
Problema Standard CEM
di base o metodo
di testing
Scarica elettro- statica IEC 61000-4-2
RF irradiata Campi IEC 61000-4-3
EM
Vicinanza di campi IEC 61000-4-3
magnetici da apparec-
chi di comunicazione
RF wireless
Campi magnetici a IEC 61000-4-8
frequenza nominale
di rete
Scoppi di transitori IEC 61000-4-4
elettrici veloci
Per porta di alimentazione di ingresso CA
linee elettriche CC o linee di ingresso/uscita del segnale con lunghezza
superiore a 3 m
Picchi IEC 61000-4-5
Disturbi condotti IEC 61000-4-6
indotti da campi
Per 1. ingresso porta alimentazione c.a.;
a radiofrequenza
2. tutte le porte di alimentazione CC collegate in modo permanente a
cavi >3m
3. tutti i cavi paziente accoppiati
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 apparecchia-
ture 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
710 707-787 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 2400-2750 Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
Banda LTE 7
5240 5100-5800 WLAN 802.11
5500 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.
Guida ambiente elettromagnetico
CISPR 11, Gruppo 1, Classe B
N/A
N/A
Ambiente sanitario Ambiente sanitario
professionale domestico
+/- 8 kV contatto
+/- 2 kV, +/- 4 kV, +/- 8 kV, +/- 15 kV aria
3V/m 10V/m
80MHz-2.7GHz 80MHz-2.7GHz
80%AM a 1kHz o 2Hz 80%AM a 1kHz o 2Hz
1kHz o 2Hz può essere specificato dal produt-
tore
Vedere la tabella degli apparecchi di comunica-
zione RF wireless nella sezione "Distanze mini-
me di separazione consigliate".
30A/m; 50 Hz 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
DIGITAL THERMOMETER (Not Waterproof)
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 first 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 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 "℃" 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
flashes. 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 flashing. 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 self-
check test, during which all the digital segments appear on the LCD. After that the last measured val-
ue 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 meas-
ured. For this reason, the measurement site must always be specified 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 fluc-
tuate 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 specification
This usability engineering process assesses and mitigated risks caused by usability problems as-
sociated 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 defined in ISO14971, associated with usability of a medical device are acceptable.
Safety precautions
Livello
• Do not allow the device to come into contact with hot water.
del test
• Do not expose to high temperatures or direct sunlight.
d'immunità
• Do not drop the thermometer. It is neither shock-proof nor impact-resistant.
(V/m)
• Do not modify this device without the authorization of the manufacturer.
• Do not bend or open the device (except the battery compartment).
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• Do not clean with thinners, petrol or benzenel. Only clean with disinfectant.
• Do not immerse the thermometers in liquid.
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• 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.
9
• 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
28 doctor!
• Do not use near strong electromagnetic fields, i.e. keep it away from any radio systems and mobile
phones.
Battery replacement
The battery is empty and needs replacing when the "
the right of the LCD. Remove the battery cover and remove the battery by toothpick, replace it with a
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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)
28
+/-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
9
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
ENGLISH
" or " " battery symbol appears on