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Hetaida HTD8823US User Manual
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Hetaida HTD8823US User Manual

Non contact infrared body thermometer
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Technical File
Non Contact Infrared Body
HeTaiDa
Non Contact Infrared Body
Thermometer
User Manual
Model: HTD8823US
Software version: V10
Thermometer
Instructions for use
File No.
ZHTF-CE-01-015
Rev. No.
Rev. Date
2020-6-8
Page
A.1
1 / 18

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Summary of Contents for Hetaida HTD8823US

  • Page 1 File No. ZHTF-CE-01-015 Technical File Rev. No. Rev. Date 2020-6-8 Non Contact Infrared Body Thermometer Page 1 / 18 Instructions for use HeTaiDa Non Contact Infrared Body Thermometer User Manual Model: HTD8823US Software version: V10...
  • Page 2 General knowledge of Infrared thermometer and an understanding of the features and functions of the HTD8823US thermometer model are prerequisites for proper use. The HTD8823US is a medical device, and can be used repeatedly with using life is 5 years. And the shelf life of HTD8823US is 5 years too.
  • Page 3 File No. ZHTF-CE-01-015 Technical File Rev. No. Rev. Date 2020-6-8 Non Contact Infrared Body 3 / 18 Thermometer Page Instructions for use Safety Information This device may only be used for the purposes described in these instructions. The manufacturer cannot be held liable for damage caused by incorrect application. 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 2020-6-8 Non Contact Infrared Body 4 / 18 Thermometer Page Instructions for use device in a dry room and protect it against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the storage case. Do not throw batteries into fire.

  • Page 5: Section 1- Overview

    Instructions for use Section 1- Overview Indication for use: The Non-contact Infrared Body Thermometer, Model: HTD8823US, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead in people of all ages for home setting use.
  • Page 6 Thermometer Applications Adult Pediatric Thermometer Thermometer Model Number Style Forehead Forehead Non Contact Infrared Body √ √ HTD8823US Thermometer Equipment Symbols Operating atmospheric Warning pressure Non sterile packaging Refer to operating Compliance with WEEE instructions Standard Operating DO NOT THROW AWAY...
  • Page 7 Page Instructions for use vertically falling water drops when enclosure titled up to 15º. Technical Specifications Measurement Unit °C /°F (HTD8823US) Operating mode Adjusted mode(Body mode) Reference Body Site Oral Rated output range 34.0°C ~ 43.0°C / 93.2°F -109.4°F Range 34.0°C ~ 43.0°C / 93.2°F -109.4°F...
  • Page 8 File No. ZHTF-CE-01-015 Technical File Rev. No. Rev. Date 2020-6-8 Non Contact Infrared Body 8 / 18 Thermometer Page Instructions for use Equipment classification Safety Standards: ANSI AAMI ES60601-1: 2005/(R)2012 and A1:2012 IEC 60601-1-2: 2015 Type of protection Internally powered equipment (on battery power) Front panel and case ISO 15223-1 : 2016 labeling...
  • Page 9 File No. ZHTF-CE-01-015 Technical File Rev. No. Rev. Date 2020-6-8 Non Contact Infrared Body 9 / 18 Thermometer Page Instructions for use  Forehead mode: press On/Scan button to open the device, the thermometer is aligned with the middle of the forehead to measure body temperature (between the eyebrows above) and keep the vertical distance, press the On/Scan button, the position lamp indicates measurement site with light spot on the forehead, temperature display immediately, see figure 3.
  • Page 10 File No. ZHTF-CE-01-015 Technical File Rev. No. Rev. Date 2020-6-8 Non Contact Infrared Body 10 / 18 Thermometer Page Instructions for use General Setup and Use  Start measuring Turn on the thermometer by pressing the On / Scan button. The thermometer will perform self-test with all segments displayed (Figure 4) for 1 second.

  • Page 11: Troubleshooting

    2) To ensure the accuracy of the measurement, wait at least 30 seconds after 5 consecutive measurements.  Unit Set ( Only applicable for HTD8823US) Turn on the thermometer by pressing the On/Scan button. The thermometer will perform self-test with all segments displayed for 1 second, and then show last measurement value. During last measurement show, press and hold on On/Scan button to enter unit switch display.
  • Page 12 File No. ZHTF-CE-01-015 Technical File Rev. No. Rev. Date 2020-6-8 Non Contact Infrared Body 12 / 18 Thermometer Page Instructions for use Battery capacity is too low. Taking Install a new battery Temperature is not allowed. Ambient temperature changes too Wait until the ambient temperature fast is stably.
  • Page 13 File No. ZHTF-CE-01-015 Technical File Rev. No. Rev. Date 2020-6-8 Non Contact Infrared Body 13 / 18 Thermometer Page Instructions for use 5-Cleaning, Care and Storage The lens is very delicate. It is very important to protect the lens from dirt and damage. This thermometer is for single patient reuse, you may use 70% isopropyl alcohol wipes to gently clean thethermometer after each use.
  • Page 14 SERVICE PERSONNEL of HeTaiDa Technology Co., Ltd. Don’t open or repair the device by yourself. 2. Please report to HeTaiDa Technology Co., Ltd. if any unexpected operation or events occur. 3. Calibration needed to ensure proper function for every two years or after device impact.
  • Page 15 File No. ZHTF-CE-01-015 Technical File Rev. No. Rev. Date 2020-6-8 Non Contact Infrared Body 15 / 18 Thermometer Page Instructions for use EMC Declaration 1) This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS;...
  • Page 16 File No. ZHTF-CE-01-015 Technical File Rev. No. Rev. Date 2020-6-8 Non Contact Infrared Body 16 / 18 Thermometer Page Instructions for use Guidance and manufacture’s declaration – electromagnetic immunity The Non Contact Infrared Body Thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of Non Contact 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 2020-6-8 Non Contact Infrared Body 17 / 18 Thermometer Page Instructions for use Guidance and manufacture’s declaration – electromagnetic immunity The Non Contact Infrared Body Thermometer is intended for use in the electromagnetic environment specified below.
  • Page 18 File No. ZHTF-CE-01-015 Technical File Rev. No. Rev. Date 2020-6-8 Non Contact Infrared Body 18 / 18 Thermometer Page Instructions for use b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m. Recommended separation distances between portable and mobile RF communications equipment and the Non Contact Infrared Body Thermometer.