Бесконтактный термометр для измерения температуры тела человека инструкция по применению

Foreword

The non contact Infrared body thermometer operating Instructions intend to provide the necessary information for proper operation of HTD8813, 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 HTD8813 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.

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 HTD8813 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.

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: tomchen@hetaida.com.cn

Company Name: Wellkang Ltd
Company Address: Suite B, 29 Harley Street LONDON W1G 9QR, England, United Kingdom
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

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 NonContact Infrared Body Thermometer is to be operated by consumers in the home setting and primary care setting as screening tool. 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 between15℃to 40℃(59℉- 104℉).
• 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.
• If measure human forehead temperature, please select «body» mode; for measure other objects, liquids, food and other temperature please select «surface» mode.
• 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 ire.

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.

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.

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

Figure 1: HTD8813 Infrared body thermometer

1. Liquid crystal display (LCD)
2. Battery Cover
3. ON/measure button
4. SET button
5. MEMO button
6. MODE button
7. IR sensor
8. Surface mode
9. Body mode
10. Data indicator
11. Indicator of measurement result
12. Low Battery indicator
13. Volume on/off indicator
14. Memory Number
15. Fahrenheit
16. Celsius
17. Memory indicator

Technical Specifications

Calculated values of the indicators according to ISO 80601-2-56

Note: the above value is calculated from clinical data of HTD8818A.

Safety classification of ME EQUIPMENT

Note: Not intended to be sterilized. Not for use in an OXYGEN RICH ENVIRONMENT

Operation

Battery installation

The Non Contact Infrared Body Thermometer does not operate with dead batteries and does not input outer power. Install new batteries.

1. Pull the battery downward, toward the bottom of the Non Contact Infrared Body Thermometer, and remove the battery access door;
2. Insert two pieces AAA size batteries according to the «+» and «-«;
3. 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.

• 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/measure button, temperature display immediately, see figure 2.
  
  Figure 2: Measuring position and distance
• 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 between15℃ to 40℃.
• The ambient temperature around the test person should be stable, should keep away from the larger low 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.
• If for some reason the low forehead temperature measurement can try to align behind the ears. See figure 3.
  
  Figure 3: Align behind the ears to measurement

General Setup and Use

• Start measuring

1. Turn on the thermometer by pressing the On/measure button. The thermometer will perform self-test with all segments displayed for 2 seconds.
2. Align staff forehead to keep the distance, and then press the On/measure button to start the measurement, read the data.

Note:

1. After full display over, you will hear a rattle or «beep beep beep» three 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 red, green, yellow one of. And the Green means ready for next measurement. When 37.4℃-38.0℃, it’s yellow, means slight fever warning. Please pay attention to body temperature. When the body temperature is above 38.1℃, it’s red, means high fever. Please take action to cool down or go for a doctor.
2. To ensure the accuracy of the measurement, wait at least 30 seconds after 5 consecutive measurements.

• Mode conversion

When the device is running, pressing the MODE button to cycle conversion between «body» mode and «surface» mode.

«body» mode is used for measuring human body temperature, the «surface » mode is used to measure the surface temperature. (The factory default is «body» mode).

• Recalling and Erasing Memory Data

The last temperature taken before the thermometer powers off is stored in memory, up to 50.

1. In the boot or shutdown state, short press the MEMO button to view the history of measured values.
2. An empty memory cell shows «—℃» or «—℉».
3. Temperature readings can be stored in memory. Up to 50 temperature readings can be stored into the memory cells and automatically overwrite historical data.
4. In boot mode, press the MEMO button until the LCD display «CLR», which means that all stored data is cleared completely conds after the long beep, which means that all stored data is cleared completely.

• Parameter settings

This product can be set according to the subjects of different colors and different environments data to meet the different characteristics of populations or individuals.

Long press the SET button to modify the measurement parameters HTD8813 as below step:

1. Unit Set-F1
   Under the boot mode. Long press SET button to enter F1, press the «MODE» or «MEMO»button to switch Celsius and Fahrenheit temperature units, press the SET button to confirm the unit settings (factory default is Celsius).
2. Fever alert set-F2
   Under F1 state, press SET button to enter the F2, press the «MODE» button to decrease 0.1 ℃, press the «MEMO» button plus 0.1 ℃, long press to accelerate the speed of temperature regulation, and finally press the SET button to save. (The factory default is 38.1 ℃)
3. Prompt sound settings-F3
   Under F2 state, short press SET button to enter F3, press MODE button or MEMO button to set voice switch, and press the SET button to confirm the settings. (The factory default is the voice Prompt to open).

• Prompt sound settings ON/OFF function
  Under the boot mode. Short press SET button to take on or take off the Prompt sound function.
• Restore to factory setting function
  Under the boot mode, long press MODE button until LCD display «rst». Two seconds later, former F1-F3 parameter back to factory setting.

Replacing the Battery

1. Open and release battery cover following indicator on the surface of battery cover. Before changing the battery be sure the system is already power off.
2. Remove the battery and replace with 2 new one, type AAA, Make sure align properly as indicated inside the battery cover.
3. 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.
4. In case, if system is latched up after changing battery. You may not follow up the process of rule one. Just take off battery, waiting 30 sec, then load battery again.

Do not recharge, disassemble or dispose of in ire.

1. The typical service life of the new and unused batteries is 2000 measurements for the operation time is 18s.
2. Only use the recommended batteries, do not recharge non-rechargeable batteries and do not burn them.
3. Remove the batteries if the thermometer is not to be used for a long period.