Gima CLINICAL THERMOMETER User Manual

PROFESSIONAL MEDICAL PRODUCTS
DIGITAL CLINICAL THERMOMETER
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.
• Note: Use of the probe cover may result in a 0.1°C discrepancy from actual temperature.
• Remove battery from the device when not in operation for a long time.
• 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 devices orally.
• If the unit has been stored at temperatures over 5°C~40°C, leave it in 5°C~40°C ambient temperature for about 15 minutes before using it.
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.
CONTENTS
1 Thermometer, 1 Owner’s Manual, 1 Storage Case
ON/OFF
Thermometric sensor LCD
Thermometer tip
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.
button
Battery compartment
SYMBOL EXPLANATION
Direct Current Lot number Product code
Caution: read instructions (warnings) carefully
Authorized representative in the European community
WEEE disposal
Temperature limit Humidity limit Atmospheric pressure limit
Keep away from sunlight Date of manufacture
Manufacturer
IP22 Covering Protection rate Keep in a cool, dry place
Follow instructions for use
Medical Device complies with Directive 93/42/EEC
Type BF applied part
SPECIFICATIONS
Type: Digital Thermometer (Not Predictive)
Measure Range: 32.0°C~42.9°C Accuracy: ±0.1℃ during 35.5℃~42.0℃ at 18℃~28℃ ambient operating range
Operating mode: Direct Mode
Display: Liquid crystal display, 3 1/2 digits
±0.2℃ for other measuring and ambient operating range
Memory: For storing the last measured value
Battery: One 1.5 V DC. button battery (size LR41or SR41, UCC 392)
Battery life: Approx. 200hours of continuous operation or 1 year with 3 measurements
Dimension: 140mmx24mmx12rnm (L x W x H)
Weight: Approx. 15 grams including battery
Expected service life: Three years Ambient operating range: Temperature: 5℃~40℃
Storage and transportation condition:
Ingress Protection Rating: IP22 Classication: Type BF
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℃.
b) Rectal Use: Lubricate silver probe tip with petroleum jelly for easy insertion.
Gently insert sensor approximately 1cm (less than 1/2 “) into rectum. Normal
temperature between 36.2℃ and 37.7℃.
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℃.
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 rapidly w hen temperature reaches 37.8℃ 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.
per day
Relative humidity: 15%~95%RH Atmospheric Pressure : 700hPa ~ 1060hPa
Temperature: -20℃~55℃
Relative condition: humidity: 15%~95%RH Atmospheric Pressure : 700hPa ~ 1060hPa
Figure 2
TROUBLESHOOTING
Error message Problem Solution
Temperature taken is lower than 32.0°C
Temperature taken is higher than 42,9°C
The system is not functioning properly.
Dead battery: Battery icon is
ashing, can’t be measurable.
Turn off, wait one minute and take a new tempera-
ture via close contact and sufcient rest.
Turn off, wait one minute and take a new tempera-
ture via close contact and sufcient rest.
Unload the battery, wait for 1 minute and repower it. If the message reappears, contact the retailer for service.
Replace the battery.
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”.) (See Figure
4)
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.
Figure 3 Figure 4 Figure 5
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, 70% 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.
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