Gima JUMBO 2 DIGITAL THERMOMETER °C User guide

PROFESSIONAL MEDICAL PRODUCTS
ENGLISH
PLEASE READ CAREFULLY BEFORE USING
This digital thermometer provides a quick and highly accurate reading of an individual’s body temperature. The digital thermometer is intended to meas­ure the human body’s temperature in regular mode orally, rectally or under the arm, and the device is reusable for clinical or home use on people of all ages. To better understand its functions and to provide years of dependable results, please read all instructions rst. This appliance conforms to the following standards: EN 12470-3 Clinical thermometers —Part 3: Performance of compact elec­trical thermometers (non-predictive and predictive) with maximum device, ISO 80601-2-56 Medical electrical equipment —Part 2-56:Particular require­ments for basic safety and essential performance of clinical thermometers for body temperature measurement, EN 60601-1-11 Medical electrical equipment —Part 1-11: General requirements for basic safety and essen­tial performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare en­vironment and complies with the requirements of EN 60601-1-2(EMC), IEC/ EN60601-1(Safety) standards. And the manufacturer is ISO 13485 certied.
Probe ON/Off ButtonLCD Battery Cap
Warning:
• Read instructions thoroughly before using digital thermometer.
• Choking Hazard: Thermometer cap and battery may be fatal if swallowed. Do not allow children to use this device without parental supervision.
• Do not use thermometer in ear. Designed use is for oral, rectal, and armpit (axilla) readings only.
• Do not place thermometer battery near extreme heat as it may explode.
• Remove battery from the device when not in operation for a long time. Note: Use of the probe cover may result in a 0.1℃(0.2℉) discrepancy from actual temperature.
The use of temperature readings for self-diagnosis is dangerous. Consult your doctor for the interpretation of results. Self-diagnosis may lead to the worsening of existing disease conditions.
Do not attempt measurements when the thermometer is wet as inaccurate readings may result.
Do not bite the thermometer. Doing so may lead to breakage and/or injury.
Do not attempt to disassemble or repair the thermometer. Doing so may
result in inaccurate readings.
After each use, disinfect the thermometer especially in case the device is used by more than one person.
Do not force the thermometer into the rectum. Stop insertion and abort the measurement when pain is present. Failure to do so may lead to injury.
Do not use thermometer orally after being used rectally.
For children who are two years old or younger, please do not use the de-
vices orally.
If the unit has been stored at temperatures over 5℃~40℃(41℉~104℉), leave it in 5℃~40℃ (41℉~104℉) ambient temperature for about 15 min­utes before using it.
PRECAUTION
The performance of the device may be degraded should one or more of the following occur:
- Operation outside the manufacturer’s stated temperature and humidity range.
- Storage outside the manufacturer’s stated temperature and humidity range.
- Mechanical shock (for example, drop test) or degraded sensor.
- Patient temperature is below ambient temperature.
* Portable and mobile RF communications can affect the device. The device
needs special pre-cautions regarding EMC according to the EMC informa­tion provided in the accompany documents.
SPECIFICATIONS
Type: Digital Thermometer (Not Predictive) Measure Range: 32.0℃ - 42.9℃° (90.0℉-109.9℉ )
Accuracy: ±0.1℃ (±0.2℉) during 35.5℃~42.0℃
Operating mode: Direct Mode Display: Liquid crystal display, 3 1/2 digits Memory: For storing the last measured value Battery: One 1.5 V DC. button battery
Battery life: Approx. 200hours of continuous operation
Dimension: 13.9cm×2.3cm×1.3cm (L×W×H) Weight: Approx. 13 grams including battery Expected service life: Three years Ambient operating range: Temperature: 5℃~40℃(41℉~104℉)
Storage and transporta­tion condition:
Ingress Protection Rating: IP 27 Classication:
DIRECTIONS
1. Press the On/Off Button next to LCD display. A tone will sound as the screen shows , followed by last recorded temperature. After show­ing the self-test temperature, the thermometer is now in the testing mode.
2. Position thermometer in desired location (mouth, rectum, or armpit.) a) Oral Use: Place thermometer under tongue as
indicated by “√” position shown in Figure 2. Close your mouth and breathe evenly through the nose to prevent the measurement from being inuenced by inhaled/exhaled air. Normal temperature between
35.7℃ and 37.3℃ (96.3℉ and 99.1℉). Figure 2
b) Rectal Use: Lubricate silver probe tip with petrole-
um jelly for easy insertion. Gently insert sensor approximately 1cm (less than 1/2″) into rectum. Normal temperature between 36.2 and 37.7℃ (97.2℉ and 99.9℉).
c) Armpit Use: Wipe armpit dry. Place probe in armpit and keep arm
pressed rmly at side. From a medical viewpoint, this method will al­ways provide inaccurate readings, and should not be used if precise measurements are required. Normal temperature between 35.2℃ and
36.7℃(95.4℉ and 98.1℉).
3. The degree sign ashes throughout the testing process. When ashing stops an alarm will beep for approximately 10 seconds. The measured reading will appear on the LCD simultaneously. The minimum measure­ment time until the signaling tone (beep) must be maintained without ex­ception. The measurement continues even after the buzzer notication. So that in order to achieve better body temperature measurement result, recommend to keep the probe in mouth and rectum about 2 minutes, or in armpit about 5 minutes regardless of the beep sound and at least 30 seconds measurement interval should be maintained.
*Note: Normally the buzzes are“ Bi-Bi-Bi- Bi-”;Alarm beeps more rap-
idly when temperature reaches 37.8 (100℉) or higher ,and the
buzzes are“ Bi-Bi-Bi----- Bi-Bi-Bi------- Bi-Bi-Bi”
4. To prolong battery life, press the On/Off Button to turn unit off after testing is complete. If no action is taken, the unit will automatically shut off after around10 minutes.
(℃/℉ chosen by manufacturer)
(95.9℉~107.6℉) at 18℃~28℃ (64.4℉~82.4℉) ambient operating range ±0.2℃ (±0.4℉) for other measuring and ambient operating range
(size LR41or SR41, UCC 392)
or 1 year with 3 measurements per day
Relative humidity: 15%~95%RH Atmospheric Pressure : 700hPa ~ 1060hPa
Temperature: -20℃~55℃(-4℉~131℉) Relative humidity: 15%~95%RH Atmospheric Pressure : 700hPa ~ 1060hPa
Type BF
TROUBLESHOOTING
Error message
Problem Solution
Temperature taken is lower than 32.0°C (90.0°F)
Temperature taken is higher than 42.9°C (109.9°F)
Turn off, wait one minute and take a new temperature via close contact and sufcient rest.
Turn off, wait one minute and take a new temperature via close contact and sufcient rest.
The system is not functioning properly.
Dead battery: Battery icon is ashing, can’t be measurable.
BATTERY REPLACEMENT
1. Replace battery when appears in the lower right corner of LCD display.
2. Pull battery cover off as shown in Figure 3.
3. Gently pull out plastic circuit board with battery chamber approximately 1 cm (slightly less than1/2
4. Use pointed object such as a pen to remove old battery. Discard battery lawfully. Replace with new 1.5V DC button type LR41 or SR41,UCC392, or equivalent. Be sure battery is installed with “+” polarity facing up. (See Figure 5)
5. Slide battery chamber back into place and attach cover.
CALIBRATION
The thermometer is initially calibrated at the time of manufacture. If the ther­mometer is used according to the use instruction, periodic readjustment is not required. However, we recommend checking calibration every two years or whenever clinical accuracy of the thermometer is in question. Turn on the thermometer and insert into the water bath and then check the laboratory accuracy of thermometer. Please send the complete device to the dealers or manufacturer. The above recommendations do not supersede the legal requirements. The user must always comply with legal requirements for the control of the meas­urement, functionality, and accuracy of the device which are required by the scope of relevant laws, directives or ordinances where the device is used.
CLEANING AND DISINFECTION
Wipe the thermometer with a soft clean cloth. For stubborn stains, wipe the thermometer with a cloth that has been damp­ened with water or a neutral detergent solution and then wring thoroughly. Finish by wiping with a soft dry cloth. For disinfection, 75% Ethanol or Isopropyl alcohol can be used. Observe the following to prevent damage to the thermometer. Do not use benzene, thinner, gasoline or other strong solvents to clean the thermometer. Do not attempt to disinfect the sensing section (tip) of the thermometer by immersing in alcohol or in hot water (water over 50℃ (122℉). Do not use ultrasonic washing to clean the thermometer.
Unload the battery, wait for 1 minute and repower it. If the message reappears, contact the retailer for service.
Replace the battery.
Type BF applied part Follow instructions for use
Manufacturer Date of manufacture
Keep in a cool,
dry place
Keep away from sunlight
Authorized represent­ative in the European community
WEEE disposal
Temperature limit IP27 Covering Protection rate
Humidity limit Direct current
Atmospheric pressure limit
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.
Product code
Lot number
Caution: read instructions (warnings) carefully
Medical Device complies with Directive 93/42/EEC
25557/DMT-4220
JOYTECH Healthcare CO., Ltd. No.365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou City, 311100 Zhejiang, China Made In China
Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg - Germany
Importato da / Imported by / Importado por / Importado por / Importé par / Importowane przez / Εισαγωγή από / :

Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
IP27
-20°C
55°C
15% 700 hPa
M25557-M-Rev.4-10.20
0197
95% 1060 hPa
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