GIMA Infrared Digital Ear Thermometer
The ear thermometer is a device capable of achieving infra-red temperature measurement when placed in the auditory canal of a subject. It is a safe means of measuring human body temperature through the ear, this product is for home and hospital use, operator shall be at least 11 years old and patient can be operator.
Specification
This appliance conforms to the standard of ISO 80601-2-56:2017/AMD 1:2018 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. This device complies with the requirements of IEC 60601-1,IEC 60601-1-11 and IEC 60601-1-2.
Range of displayed temperature:34.0°C ~ 44.0°C Display L°C, when the temperature is under 34,0°C Display H°C, when the temperature is over 44,0°COperating ambient:Temperature: 16°C ~35°CHumidity: <= 85% RHAtmospheric pressure: 700~1060hPaAltitude: <2000mStorage and transport condition:Temperature: from -25°C to 55°CHumidity: <= 85% RHDisplay resolution temperature range: 0.1°CAccuracy: ±0.2°C (from 35.5°C to 42.0°C ) / ± 0.3°C (from 34.0°C to 35.5°C, from 42.0°C to 44.0°C)Display: liquid crystal display, 3,5 digitstemperature unit: centigradedisplay of memory: last ten memorieslow voltage warning: the LCD display 
Power consumption: 0.5 milliwatt in measurement modeBattery: one 3V Lithium battery (CR 2032)Battery life: 2500 takes or 4 months with 3-min. usage per dayShelf life: 3 yearsDimension: 114mm x 35mm x 40mmNet weight: 36gBeeper sign: on/off, measuring finish, etc.Self-testing sequence: Press the `on/recall’ button to turn on the thermometer and all of symbol (See Fig. A) should be displayed on the LCD in one second.Calibration frequency: If used privately no calibration is needed. For professional use it is recommend to check once 2 year.Manufacturing and Calibration date: See the label in the battery box.Mode of operation of the clinical thermometer: adjusted modeReference body site: oral
Cautions
- Before measuring, the thermometer shall be stabilized at least 30min under operating condition.
- Please keep your ear canal clear, if not, the measuring result shall be inaccurate.
- The symbol ` ‘ on the LCD shows you can measure in the ear;
- The time between each reading should be not less than 12 Seconds otherwise there is not any change on the LCD.
- Please don’t scratch the probe lens, if not the thermometer shall lose the efficacy;
- If the LCD no changes under pressing any button, please take the battery out and put in again.
- Please don’t use the thermometer if your ear canal has been inflammation.
- Do not expose this thermometer to electric shock.
- Do not expose the thermometer to sunlight or to water.
- Do not modify this device without authorization of the manufacturer.
- Do not use near strong electromagnetic fields, i.e. Keep it away from any radio systems and mobile phones.
- This device must always be kept in a clean, dry area.
- Degree of protection against electric shock is Type BF applied part.
- The disposal of battery and device shall comply with the local environment requirements
- This device include small parts, don’t inhale or swallow it.
- Do not apply a strong shock to, drop, step on, or vibrate the main unit.
How to use
Measuring human body temperature in the Ear Canal.
- Press the `on/recall’ button to turn on the thermometer, a beep sound is heard and the LCD displays as Fig. A in one second.When the LCD displays as Fig. B, now ready to measure.
- Straighten the ear canal by pulling the outer ear up and back to give a clear view of the eardrum.– For children under 1 year, Pull the ear straight back.– For children ages 1 year to adult, Pull the ear up and back. (Caution: Many pediatricians suggest use of ear thermometers for children older than 6 months.)
- While pulling the outer ear, insert the probe snugly into the ear canal (best to insert deep), press the `scan’ button.Release it when you hear a beep sound. A beep indicates measurement is complete. Remove the thermometer from the ear. The display show the measure temperature.
- Measuring again: If measuring again, please unclinch the `scan’ button and wait for the `‘ symbol to display, then press `scan’ button to measure again. Note: The time between each reading should be not less than 12 seconds otherwise there is not any change on the LCD.
- Memory search: Press the `on/recall’ button, the last ten memories (NO.9-NO.0) will take turns to display on the LCD as Fig. C and Fig. D.
- The LCD will displays ‘Er1’ as Fig. E and cannot displays temperature when the ambient temperature is out of the range of 16°C to 35°C.Note: Before measuring, the thermometer shall be stabilized at the operating ambient condition for a minimum of 30 min.
- Shut off: The thermometer shall automatically shut off without manipulating in one minute.
When the LCD displays as Fig. B, now ready to measure.
– For children ages 1 year to adult, Pull the ear up and back. (Caution: Many pediatricians suggest use of ear thermometers for children older than 6 months.)
‘ symbol to display, then press `scan’ button to measure again. Note: The time between each reading should be not less than 12 seconds otherwise there is not any change on the LCD.
Note: Before measuring, the thermometer shall be stabilized at the operating ambient condition for a minimum of 30 min.Cleaning and Storage
- Store thermometer in a dry location free from dust and contamination and away from direct sunlight. The ambient temperature at the storage location should remain fairly constant and within the range of -25°C to 55°C.
- Use an alcohol swab or cotton swab moistened with alcohol (70% Isopropy) to clean the thermometer casing and the measuring probe before each use.Ensure that no liquid enters the interior of the thermometer.
- Never use abrasive cleaning agents, thinners or gasoline for cleaning and never immerse the instrument in water or other cleaning liquids. Take care not to scratch the surface of the probe membrane or display.
Replacing the batteries
- When voltage of the battery is low, the LCD will display ” ” symbol, please replace a new battery in the unit. The thermometer cannot work accurately under the condition of low voltage.
- The thermometer is supplied with one 3 V LITHIUM BATTERY (CR 2032), Insert new battery when the low voltage symbol appears on the LCD.
- Screw off the bolt and remove the battery cover and take out the old battery.
- Place new battery according to the “+” or “-“
- Please take out the battery to avoid battery leaking if unit not used for over six months.
- The disposal of battery and device shall comply with the local environment requirements. The lithium battery or fuel cell may lead to excessive temperatures, fire or explosion.
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Caution: read instructions (warnings) carefully |  |
Follow instructions for use |
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Keep in a cool, dry place |  |
Keep away from sunlight |
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Manufacturer |  |
Date of manufacture |
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Lot number |  |
Product code |
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Medical Device complies with Directive 93/42/EEC |  |
Authorized representative in the European community |
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IP22 |
Covering Protection rate |  |
WEEE disposal |
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Type BF applied part |  |
Direct current |
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Temperature limit |  |
Humidity 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 specific recycling point for electric and electronic equipment.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
25579 / ET-100B
Hangzhou Hua’an Medical & Health Instruments Co., Ltd.Building 2, 1# Fuzhu Nan RD, Wuchang Town, Yuhang District, Hangzhou, Zhejiang 310023, ChinaMade in China
Shanghai International Holding Corp. GmbH (Europe)Eiffestrasse 80, 20537 Hamburg Germany
Imported by S.p.A.Via Marconi, 1 – 20060 Gessate (MI) Italy – [email protected]www.gimaitaly.com
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References
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