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Hetaida HTD8808E User Manual

Non contact infrared body thermometer
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Technical File
Non Contact Infrared Body
Instructions for use
HeTaiDa
Non Contact Infrared Body
Thermometer
User Manual
Model: HTD8808E
So�ware version : V31
Thermometer
File No.
ZHTF-CE-01-015
Rev. No.
A.5
Rev. Date
2020-07-10
Page
1 / 24

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Summary of Contents for Hetaida HTD8808E

  • Page 1 File No. ZHTF-CE-01-015 Technical File Rev. No. Rev. Date 2020-07-10 Non Contact Infrared Body Thermometer Page 1 / 24 Instructions for use HeTaiDa Non Contact Infrared Body Thermometer User Manual Model: HTD8808E So�ware version : V31...
  • Page 2 Only body mode was reviewed and certified by notified body. General knowledge of Infrared thermometer and an understanding of the features and functions of the HTD8808E thermometer model are prerequisites for proper use. The non contact infrared body thermometer is a medical device, and can be used repeatedly, which using life is 5 years.
  • Page 3 File No. ZHTF-CE-01-015 Technical File Rev. No. Rev. Date 2020-07-10 Non Contact Infrared Body Thermometer Page 3 / 19 Instructions for use The non contact infrared body thermometer is designed to minimize the possibility of hazards from errors in the software program by following sound and light engineering design processes, Risk Analysis and Software Validation.
  • Page 4 File No. ZHTF-CE-01-015 Technical File Rev. No. Rev. Date 2020-07-10 Non Contact Infrared Body Thermometer Page 4 / 19 Instructions for use The device should be kept out of the reach of children/pets. When not in use, store the device in a dry room and protect it against extreme moisture, heat, lint, dust and direct sunlight.

  • Page 5: Section 1- Overview

    Instructions for use Section 1- Overview Intended Use The HeTaiDa Non Contact Infrared Body Thermometers are designed to be used for intermittent measurement and monitoring of human body temperature by consumers in the home setting and primary care setting as screening tool.
  • Page 6 Instructions for use Thermometer Applications Thermomete Adult Pediatric Thermometer Forehea Forehea Model Style Number Contact Infrared Body HTD8808E Thermometers Equipment Symbols Operating atmospheric Warning pressure Non sterile packaging Refer to operating Compliance with WEEE instructions Standard Operating DO NOT THROW AWAY Temperature...
  • Page 7 Note: 1.Surface mode is always with Green backlight. 2. In body mode 34.0-35.4°C is with green backlight. Auto Power Off Time HTD8808E Measuring Time Measuring Distance HTD8808E: 0.1CM -15CM(0.04 in -5.9in) Memories HTD8808E 50 Power Supply Requirements Power 1.5V (AAA) Alkaline batteryX2 (IEC Type LR03)or DC 5V(MicroUSB) Adaptable Range 2.6V~3.6V...
  • Page 8 Transport and Storage Storage Temperature:-20°C -55°C / -4 °F - 131°F, Relative Condition Humidity 93%,atmospheric pressure:70 Kpa -106Kpa Dimension and Weighting Weight (without batteries) HTD8808E: 116g Size HTD8808E: L:150mm X W:95mm X H:44mm Compliance with Equipment classification Safety Standards: 60601-1: 2006+A1:2013,...
  • Page 9 File No. ZHTF-CE-01-015 Technical File Rev. No. Rev. Date 2020-07-10 Non Contact Infrared Body Thermometer Page 9 / 19 Instructions for use Applied part Non Applied part Protection against harmful ingress of water or IP22 particulate matter Mode of operation Continuous operation Note: Not intended to be sterilized.
  • Page 10 File No. ZHTF-CE-01-015 Technical File Rev. No. Rev. Date 2020-07-10 Non Contact Infrared Body Thermometer Page 10 / 19 Instructions for use minutes, to be consistent with the ambient temperature after the re-measurement. Wait at least 1 second for the next measurement. If the continuous measurement of five times, it is recommended to wait at least 30 seconds and then continue measurement.
  • Page 11 Recalling and Erasing Memory Data The last temperature taken before the thermometer powers off is stored in memory, up to 50 for HTD8808E. HTD8808E as below step: In the boot or shutdown state, short press the down" "function key, or press the up"...

  • Page 12: Troubleshooting

    Typical human temperature range. measurement, other (34.0~43.0 or 93.2 ~109.4 ). human body site. Measured over the distance Optimum measurement HTD8808E 0.1-15cm distance is 1cm. (0.04-5.9in) Incorrect test position. See figure 5 Measuring position and distance. Subjects forehead hair, Subjects sit quietly 5-10 Antipyretic stickers, head with minutes before the test.
  • Page 13 File No. ZHTF-CE-01-015 Technical File Rev. No. Rev. Date 2020-07-10 Non Contact Infrared Body Thermometer Page 13 / 19 Instructions for use The screen flicker, automatic Replace battery or the product has turn off. been damaged, needs repairs. Battery capacity is too low. Taking Install a new battery Temperature is not allowed.
  • Page 14 Always keep the thermometer within the storage temperature range (- 20 to 55 or – 4 to 131 ) and humidity range ( 93% non-condensing) for HTD8808E. It is recommended to store the thermometer in a dry location free from dust. Do not expose the thermometer to direct sunlight, high temperature/ humidity or any extreme environment, otherwise the function will be reduced.
  • Page 15 File No. ZHTF-CE-01-015 Technical File Rev. No. Rev. Date 2020-07-10 Non Contact Infrared Body Thermometer Page 15 / 19 Instructions for use 3. The patient is an intended operator. The patient can measure and change battery. Under normal circumstances and maintain the device and its accessories according to the user manual.
  • Page 16 File No. ZHTF-CE-01-015 Technical File Rev. No. Rev. Date 2020-07-10 Non Contact Infrared Body Thermometer Page 16 / 19 Instructions for use Guidance and manufacture’s declaration – electromagnetic immunity The Infrared Body Thermometeris intended for use in the electromagnetic environment specified below. The customer or the user of Infrared Body Thermometer should assure that it is used in such an environment.
  • Page 17 File No. ZHTF-CE-01-015 Technical File Rev. No. Rev. Date 2020-07-10 Non Contact Infrared Body Thermometer Page 17 / 19 Instructions for use Guidance and manufacture’s declaration – electromagnetic immunity The Infrared Body Thermometer is intended for use in the electromagnetic environment specified below. The customer or the user ofthe Infrared Body Thermometer should assure that it is used in such an environment.
  • Page 18 File No. ZHTF-CE-01-015 Technical File Rev. No. Rev. Date 2020-07-10 Non Contact Infrared Body Thermometer Page 18 / 19 Instructions for use 9- Body temperature Body temperature varies from person to person and fluctuates during the course of the day. For this reason, it is suggested to know one's normal, healthy forehead temperature to correctly determine the temperature.
  • Page 19 (E1965-98) Except of clause 5.2.2. It displays subject’s temperature over a range of 34.0~43.0 . Full responsibility for the conformanceof this product to the standard is assumed by (Hetaida Technology Co., Ltd. Adds: Room 801, 802,803,804,901, 2# Building Scientific Research Center, Songhu lntelligent Valley, No.6 Minfu Road, Liaobu Town, Dongguan City, Guangdong Province,P.R.China...