Non Contact Infrared Body
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.
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
Contact: Tom. Chen
E-mail: [email protected]
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: [email protected]
About this manual edition
Current Updated Edition/Revision: A.1, April,13rd, 2020;
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.
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 highertemperature, 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 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.
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.
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
Thermometer Applications
Equipment Symbols
Technical Specifications
Calculated values of the indicators according to ISO 80601-2-56
Safety classification of ME EQUIPMENT
Note: Not intended to be sterilized. Not for use in an OXYGEN RICH ENVIRONMENT
Operation
Battery installation
Caution: The Non Contact Infrared Body Thermometer does not operate with dead batteries and does not input outer power. Install new batteries.
- Pull the battery downward, toward the bottom of the Non Contact Infrared Body Thermometer, and remove the battery access door;
- Insert two pieces AAA size batteries according to the “+” and “-”;
- Close the battery cover.
How to Operate
Before Applying the Thermometer
Be sure to read and understand all warnings listed of the instructions before 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.
Figure 3-Measuring position and distance - Forehead Scan mode: gently position the probe flush (flat) on the center of the forehead, midway between the eyebrow and the hairline. Press and hold the On/Scan button. Lightly slide the thermometer across the fore-head keeping the sensor flat and in contact with the skin until you reach the hairline, release the On/Scan button and remove the thermometer from the head, then the temperature will display on the screen. The whole process takes 3~10 seconds.
- 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.
- The ambient temperature around the test person should be stable, should keep away from the larger flow fan, air-conditioning vents and so on.
- When people moving from one place of lower temperature to another place of higher temperature, should at least remain in the test environment more than 5 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.
- You cannot use the thermometer in place where the sun is strong.
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.
Figure 4- All segments displayed - And then show last measurement value (Figure 5), and back to ready display for measurement displayed ‘- – – -‘. (Figure 6)
Figure 5 – Last memory display
Figure 6 – Ready display for measurement - Forehead mode: Align staff forehead to keep the distance, and then press the On/Scan button, the position lamp indicates measurement site with light spot on the forehead, and start the measurement, read the data.
- Forehead scan method: position the probe flush (flat) on the center of the forehead, midway between the eyebrow and the hairline. Press and hold the On/Scan button. Lightly slide the thermometer across the fore-head keeping the sensor flat and in contact with the skin until you reach the hairline, release the On/Scan button and remove the thermometer from the head, then the temperature will display on the screen. The whole process takes 3~10 seconds.
Note:
- After full display over, you will hear a rattle or “bibi” four times, which means that the measurements have been completed, while the target value of the measured temperature is displayed on the LCD, while backlit display according to the appropriate setting among the three colors green, yellow, orange one of. And theGreen means ready for next measurement. When 37.5°C ~ 38.5°C, it’s yellow,
means slight fever warning. Please pay attention to body temperature. When the body temperature is 38.6°C or above, it’s orange, means high fever. Please take action to cool down or go for a doctor. - 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. When display unit what you want, release On/Scan button saving the setting, and back to ready display for measurement displayed ‘- – – -‘.
Troubleshooting
Replacing the Battery
- Open and release battery cover following indicator on the surface of shell. Before changing the battery being sure the system is already power off.
- Remove the batteries and replace with 2 new one, type AAA, Make sure align properly as indicated inside the battery compartment
- Slide the battery cover back in until it snaps in place.
Do not dispose of used batteries in household waste. Take them to special local collection sites. - In case, if system is latched up after changing battery. You may not follow up theprocess of rule one. Just take off battery, waiting 30 sec, then load battery again.
Warning
- The typical service life of the new and unused batteries is 2000 measurements for the operation time is 18s.
- Only use the recommended batteries, do not recharge non-rechargeable batteries and do not burn them.
- Remove the batteries if the thermometer is not to be used for a long period.
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.
Rubbing device (including markings) by hand without undue pressure with 70% isopropyl alcohol, especially skin contact part, such as the probe, shell, LCD for 15s after each measurement, wiping sensor of thermometer (which is in the center of probe surrounded by ABS case) gently for 3s
using a cotton swab wetted 70% isopropyl alcohol if dirty.
Always keep the thermometer a within the storage temperature and humidity range as specified.
It is recommended to store the thermometer in a dry location free from dust.
Always keep the thermometer within the storage temperature range (- 20°C to 55°C or – 4°F to 131°F) and humidity range (≤ 95% non-condensing)
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.
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.
Disposal
- Used batteries should not be disposed of in the household rubbish. Used Batteries should be deposited at a collection point.
- At the end of its life, the appliance should not be disposed of in household rubbish. Enquire about the options for environment-friendly and appropriate disposal. Take local regulations into account.
Warranty
Our company warrants Non Contact Infrared Body Thermometer at the time of its original purchase and for the subsequence time period of one year.
The warranty does not cover the followings:
- The device series number label is torn off or cannot be recognized.
- Damage to the device resulting from misconnection with other devices.
- Damage to the device resulting from accidents.
- Changes performed by users without the prior written authorization of the company.
- Batteries and packaging are not covered under warranty.
When asked to provide warranty service, you must have a purchase date and purchase stamp dealers (including dealers name and address) of the warranty card. Be sure to ask the dealer to purchase this product signature on the warranty card. When asked to provide warranty service, please put the product to get our distribution points for repair. Products outside the warranty expires, will be charged accordingly.
Note
- If you have any problems with this device, such as setting up, maintaining or using, please contact with SERVICE PERSONNEL of HeTaiDa Technology Co., Ltd. Don’t open or repair the device by yourself.
- Please report to HeTaiDa Technology Co., Ltd. if any unexpected operation or events occur.
- Calibration needed to ensure proper function for every two years or after device impact.
- 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.
EMC Declaration
- This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS; This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment.
- Caution: Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit.
- Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation!
- Caution: this machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used.
