Instructions for Use (IFU) of ThermArt Model: IR-EFT Comper Chuangxiang(Beijing)Technology Co.
Table of Contents Information of Manufacturer ................................................................................................................................. 1 Product introduction .............................................................................................................................................. 2 Intended use...........................................................................................................................................................
Information of Manufacturer Manufacturer: Comper Chuangxiang(Beijing)Technology Co., Ltd Address : Room 102,103 - F1, Room 203,213 - F2, Building 4, No. 1 Kangding Street, Beijing Economic-Technological Development Area, Beijing 100176, China Contact Phone: 0086 -10-57480968 Production date: See the device labels. Product Lot No./Serial No.: See the box labels. Shelf life: 3 years. Version: A/0 Revised Date: July 23, 2019 Please read the instructions carefully before using the product.
Product introduction ThermArt is an infrared forehead and ear thermometer which is hand-held, non-sterile, reusable and battery-powered. It is designed to measure human body temperature via one of two body sites: the ear canal or skin of the forehead. The device uses infrared technology to measure the natural thermal infrared energy emitted from the surface of the skin of the forehead or from the eardrum tissue.
Specifications Product name ThermArt Model IR-EFT Measurement Mode: Forehead temperature mode: 89.6°F – 109.4 °F/32.0°C-43°C Temperature range display Ear temperature mode: 89.6°F – 109.4 °F / 32°C-43°C Calibration Mode: Forehead temperature mode: 71.6°F – 109.4 °F/22.0°C-43°C Ear temperature mode: 89.6°F – 109.4 °F / 32°C-43°C ±0.4°F/±0.2°C (89.6°F – 109.4 °F/32.0°C-43°C) Precision ±0.5°F/±0.3°C (outside this temperature range) Temperature unit ℃/ ℉, adjustable Display resolution 0.1℃(0.
How to use Please follow the steps below to achieve the best measurement results. 1. Remove the forehead probe, open the battery compartment, make sure the poles are in right direction and install the batteries. 2. Press“Power/Measure”button to turn the thermometer on. 3. The display shows all segments to complete an internal self-check, then you can start measuring process after hearing a beep. 4.
it is critical to know the individual’s normal body temperature when he/she is well. Take multiple readings to obtain the normal body temperature range and note the specific body site measured, for example: forehead or eardrum temperature. Body Site Normal Temperature Range Forehead 94.5℉-99.1℉ (34.7℃-37.3℃) Eardrum 96.4℉-100.4℉ (35.8℃-38.0℃) Mouth 95.9℉-99.5℉ (35.5℃-37.5℃) Armpit 94.5℉-99.1℉ (34.7℃-37.3℃) Rectal 97.9℉-100.4℉ (36.6℃-38.
The ThermArt thermometer is supplied with two AAA alkaline batteries. For best performance, please insert new battery when the battery symbol “ ” appears on the display. Precautions 1) Please install the forehead probe and ear probe cover correctly to ensure accurate measurement. 2) The forehead mode is contact measurement. Please contact the forehead probe to the center of your forehead during measurement. 3) Please use clean and undamaged new ear probe cover for each ear temperature measurement.
17) DO NOT submerge the thermometer in any type of liquid, it is not waterproof. When wet due to contact with steam, wait until dry or gently wipe with a soft dry cloth. 18) DO NOT use the thermometer under an ambient temperature higher than 40°C (104°F) or lower than 15°C (59°F), which is beyond the operating temperature range of the thermometer. To ensure accurate readings, keep the thermometer under room temperature for more than 30 minutes before use.
Precautions for battery installation or replacement 1. When opening the battery cover to replace the batteries, pay attention to the positive and negative poles. Incorrect mounting will cause damage to the product. 2. In long period storage, please remove the batteries to prevent damage to the thermometer by fluid leakage. 3. Do not use the batteries in case of battery leakage or mold. 4. Do not take the battery close to the fire or put it into the fire to avoid battery explosion. 5.
safekeeping. 3) Safekeeping When not in use, store the thermometer in a locker or box. 4) Maintenance period It is recommended to clean and maintain the thermometer after each use. Product repair Do not repair the product by yourself. In case of any quality issue or any doubt about the measurement accuracy of the thermometer, please contact the dealer or the manufacturer.
Troubleshootings Symptom Possible cause Solution The thermometer is used within 30 Remove the thermometer from the minutes after taking from a cold situation and wait for 30 minutes in The thermometer probe is exposed a steady-state room condition before taking a temperature. to direct sunlight for a long time. High measurement result The thermometer is used on an Please take individual in excited emotion getting calm.
40℃(59.0℉-104.0℉)room for 30 minutes. Statement The ThermArt is to measure human body temperature by detecting natural thermal infrared radiation from the forehead or ear. It has been clinically proven in accuracy and repeatability. Its safety and effectiveness are both in compliance with the relevant international regulatory requirements. Description on the replacement cycle and method of consumables-- batteries The detachable components of this product mainly are the batteries.
⚫ See details of guidance and manufacturer's statement in the subsequent “Guidance and Manufacturer's Statement”.
relative humidity should be at least 30%. Electrical transient burst fast IEC61000-4-4 ±2 kV, to power supply lines Not applicable Not applicable Not applicable Not applicable ±1 kV, to input/output lines ± 1 kV differential mode voltage Surge IEC61000-4-5 ± 2 kV, common mode voltage <5% UT, for 0.
conduction 150 kHz~80 MHz applicable Recommended separation distance IEC61000-4-6 d = 1 .2 P 3 V/m RF radiation 80 MHz~2.5 GHz 3 V/m d = 1.2 P 80 MHz~800 MHz d = 2.3 P 800 MHz~2.5 GHz IEC61000-4-3 where: P —The maximum rated output power of the transmitter in watts (W) according to the transmitter's manufacturer; d—The recommended distance in m b.
communication equipment (transmitters) and the equipment or system, according to the maximum rated output power of the communication equipment. Separation distance according to the frequency of transmitter/m Maximum rated output power of transmitter/W 150 kHz~80 MHz 0.01 Not applicable 0.12 0.23 0.1 Not applicable 0.38 0.73 1 Not applicable 1.2 2.3 10 Not applicable 3.8 7.3 100 Not applicable 12 23 80 MHz~800 MHz d = 1 .2 P d = 1 .2 P 800 MHz~2.5 GHz d = 2.
and tests. ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels, labeling and information to be supplied -- Part 1: General requirements. IEC 60601-1-11:2015 Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
Federal Communications Commission (FCC) Statement This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: 1) This device may not cause harmful interference and 2) This device must accept any interference received, including interference that may cause undesired operation. 15.21 Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment 15.
Copyright Statement The copyright is reserved by Comper Chuangxiang(Beijing)Technology Co., Ltd, which enjoys and retains all the exclusive rights of copyright according to law. No part of this document may be modified, excerpted, reproduced, or otherwise, in any form without prior written permission of the company. Regarding the contents of this document, the company assumes no express or implied warranties or guarantees.