HeTaiDa HTD8823US User Manual
Technical File
File No.
ZHTF-CE-01-015
Rev. No.
A.1
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date
2020-6-8
Page
1 / 18
HeTaiDa
Non Contact Infrared Body
Thermometer
User Manual
Model: HTD8823US
Software version: V10
Technical File
File No.
ZHTF-CE-01-015
Rev. No.
A.1
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date
2020-6-8
Page
2 / 18
Foreword
The non contact Infrared body thermometer operating Instructions intend to provide
the necessary information for proper operation of HTD8823US thermometer model.
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 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.
Please read the manual first before using it, if not fully understand the usages, please stop
using the thermometer.
Do not operate any of the models HTD8823US thermometer without completely
reading and understanding these instructions.
NOTICE
Purchase or possession of this device does not carry any express or implied license to use
with replacement parts which would, alone or in combination with this device, fall within the
scope of one of the relating patents.
For further information contact:
Hetaida Technology Co., Ltd.
Adds: 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area, DaLingShan Town,
DongGuan City, Guangdong, China
Tel: +860769-82658050
Fax: +86 0769-82658050 0598
Contact: Tom. Chen
E-mail: tomchen@hetaida.com.cn
Company Name: Wellkang Ltd
Company Address: 16 Castle St, Dover, CT16 1PW, UK
Tel: +44 (20)30869438, 32876300
Fax: +44(20)76811874
Web: www.CEmark.com, www.CE-marking.com, www.CE-marking.eu,
Email: AuthRep@CE-marking.eu
About this manual edition
Current Updated Edition/Revision: A.1, April,13rd, 2020;
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Technical File
File No.
ZHTF-CE-01-015
Rev. No.
A.1
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date
2020-6-8
Page
3 / 18
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.
Warning
Warnings are identified by the WARNING symbol shown above.
The Non Contact Infrared Body Thermometer is to be operated by consumers in the
household environment, nursery school and doctor in clinics. This manual, accessories,
Directions for Use, all precautionary information, and specifications should be read
before use.
This product is designed to measure human body temperature on the forehead. Do not
use it for any other purpose.
This product is intended in the home setting and primary care setting as screening tool.
Do not use the thermometer if it malfunctions or has been damaged in any matter.
When the ambient temperature of the thermometer changes too much, such as moving
the Thermometer from one place of lower temperature to another place of higher
temperature, Allow the thermometer to remain in a room for 30 minutes where the
temperature is between 5°C to 40°C (41°F - 104°F).
Remove primary batteries if equipment is not likely to be used for long time.
This product is not waterproof, do not be immersed in water or other liquid; If cleaning
and disinfection, please follow the "Care and Storage" section requirements.
Do not touch the sensor of infrared detection with your fingers.
If a cold compress on the forehead fever patients, or take other measures to cool down
the temperature data will low, should be avoided in this case to measure body
temperature.
This product must be operated in a stable environment, if the ambient environment was
mutations, please should be note whether there is fog on the sensor, if any, before using
accordance with the "Care and Storage" section to removing the fog.
Do not near strong electrostatic field or strong magnetic fields, thus avoiding the impact
on the accuracy of the measurement data.
Do not mix the old and new batteries to avoid damage to the product.
It may affect the accuracy of measurements when the forehead is covered by hair,
perspiration, cap or scarf.
The measuring result of this product is only for your reference. If you have any doubt,
please measure the temperature in other methods.
The device should be kept out of the reach of children/pets. When not in use, store the
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Technical File
File No.
ZHTF-CE-01-015
Rev. No.
A.1
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date
2020-6-8
Page
4 / 18
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.
Only use recommended batteries. Do not use rechargeable batteries.
This thermometer will irreplaceable the diagnostic in hospitals.
Do not fall, disassemble or modify the device.
Do not use this device if you think it is damaged or notice anything unusual.
This device comprises sensitive components and must be treated with caution. Observe
the storage and operating conditions described in the ‘Technical Specifications’ section.
Not servicing/maintenance while the thermometer is in use.
When using, shall not touch battery and the patient simultaneously.
Do not use the device if it is damaged/ degraded/loosened in any way. The continuous
use of a damaged unit may cause injury, improper results, or serious danger.
Based on the current science and technology, other potential allergic reactions are
unknown.
This equipment needs to be installed and put into service in accordance with the
information provided in the ACCOMPANYING DOCUMENTS.
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Technical File
File No.
ZHTF-CE-01-015
Rev. No.
A.1
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date
2020-6-8
Page
5 / 18
Figure 1: Structure description
1. IR sensor
2. Position lamp
3. Liquid crystal display (LCD)
4. On/Scan button
5. Battery Cover
1. Memory indicator
2. Data indicator
3. Indicator of measurement result
4.Speaker
5. Battery indicator
6.Unit
Figure 2: LCD description
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.
Description of Non Contact Infrared Body Thermometer
Device principle and introduction
The HeTaiDa Non contact infrared body thermometer are hand-held, reusable,
battery operated devices, which can measure human body temperature on forehead,
the skin temperature on one's forehead.
The operation principle is based on Infrared Sensor technology. The IR sensor can
output different signal when measuring different object temperature or in different
ambient temperature, and the ASIC can turn the signal from IR Sensor to a digital
value and display it on the LCD.
Description on Controls, Indicators, and Symbols
5
Technical File
File No.
ZHTF-CE-01-015
Rev. No.
A.1
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date
2020-6-8
Page
6 / 18
Thermometer Applications
Thermometer
Model Number
Thermometer
Style
Adult
Pediatric
Ear
Forehead
Ear
Forehead
HTD8823US
Non Contact Infrared Body
Thermometer
√
√
Warning
Operating atmospheric
pressure
Non sterile packaging
Refer to operating
instructions
Compliance with WEEE
Standard
Operating
Temperature
DO NOT THROW AWAY
Intended for multiple use
Operating Humidity
Indicates this device is in
compliance with MDD
93/42/EEC. 0598 is the
Notified Body Number
This device compiles
with Part 15 of
FCC( Federal
Communications
Commission) Rules.
Restriction of Hazardous
Substances
Manufacturer
Authorized
Representative in the
European community
Recyclable
Serial number
IP22
IP22: The first number
2: Protected against
solid foreign objects of
Ф 12.5 mm and greater.
The second number:
Protected against
Batch code
Equipment Symbols
6
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