Only Body Mode was reviewed and certi�ied by Noti�ied Body. General knowledge of Infrared Thermometer and an understanding of the features and functions of the HTD8220US Thermometer model are prerequisites for proper use. The Infrared Body Thermometer is a medical device, and can be used repeatedly, which using life is 5 years.
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Warning Warnings are identi�ied by the WARNING symbol shown above. The 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 speci�ications should be read before use.
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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 �ield or strong magnetic �ields, thus avoiding the impact on the accuracy of the measurement data.
DOCUMENTS. 1- Overview Indication for use The Infrared Body Thermometer, Model: HTD8220US, is an electronic clinical thermometer using an infrared sensor for the intermittent determination of body temperature from the auditory canal in people of all ages for home setting use.
Thermometer Applications Thermometer Applications Adult Pediatric Thermometer Thermometer Style Model Number Ear Forehead Ear Forehead Infrared Body Thermometer HTD8220US × × Equipment Symbols Restriction of Hazardous Warning Substances Batch code Non sterile Packaging Compliance with WEEE Refer to operating instructions...
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Technical Speci�ications ℉/℃ Adjusted mode(Ear mode) Measuring site Reference Body Site Oral Rated output range 34.0~43.0℃/93.2°F -109.4°F 34.0~34.9℃:±0.3℃/ 93.2°F -94.8°F:±0.5°F; 35.0~42.0℃:±0.2℃/95.0°F -107.6°F:±0.4°F; 42.1~43.0℃:±0.3℃/107.8°F -109.4°F: ±0.5°F; 0.1℉/0.1℃ Display Resolution Alarm of Background 34-37.4°C/93.2°F -99.3°F: Green (Normal Temperature); light 37.5°C-38.5°C/99.5°F-101.3°F: Yellow (Slight High temperature); ( if have this feature) 38.6-43.0°C/101.5°F-109.4°F:Red (High temperature) ≤35S...
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Dimension and Weighting Weight (without batteries) Size 93.6mm×51.3mm×24.5mm (Length×Width ×Height) Compliance Item Compliant with Equipment classi�ication Safety Standards: ANSI AAMI ES60601-1:2005/(R) 2012 and A1:2012+A2:2021, IEC 60601-1-2: 2014+A1:2020 Type of protection Internally powered equipment (on battery power) Front panel and case labeling ISO 15223-1:2021 Temperature ASTM E1965-98 (reapproved 2016)
Safety classi�ication of ME EQUIPMENT Protection against electric shock Internally powered ME equipment Degree of protection Type BF - Applied part(the probe) Protection against harmful ingress of IP22 water or particulate matter Mode of operation Continuous operation Note: Not intended to be sterilized. Not for use in an OXYGEN RICH ENVIRONMENT. 2- Operation 2.1 Battery installation Caution:The Infrared Body Thermometer does not operate with dead...
2.2 How to Operate 1) Ear mode: Remove the cap and insert ear thermometer probe slightly into the ear canal, then press the Measuring button, measurement will be �inished within 2 seconds. 2) Please keep the ear canal and probe surface clean when ear temperature measurement.
2.3 Start measuring 2.3.1 Ear temperature measurement 1).Press On/Memo button to turn on the thermometer. The thermometer will perform self-test with all segments displayed. See �igure 1 2).After self-test is completed, the device is ready to measurement with “ - - -“ , see �igure 2 Figure 1 Figure 2 3).If person to measure is more than one year old, please pull the ear up...
2.4 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 state, short press the On/Memo button to view the history of measured values. 2) An empty memory cell shows “---℉”. 3) Temperature readings can be stored in memory.
MESSAGE SITUATION SOLUTION Battery capacity is too low.Taking Temperature Install a new battery is not allowed. The interval between Error warning the two measurements is not up to 5S Ambient temperature is unstable. Ambient temperature is Please allow it to acclimate for at unstable.
5-Cleaning, Care and Storage 1). Cleaning: Purpose: This thermometer is for single patient reuse to measure body temperature, you may clean the surface of thermometer since which can be contaminated during use with organic soil and microorganisms carried by human hands immediately after each use. Cleaning Agent: 70% isopropyl alcohol wipe.
2). Care The lens is very delicate. It is very important to protect the lens from dirt and damage. The Infrared probe is very delicate. Do not touch or use tools press it. Must be carefully protected otherwise it will affect the accuracy of the measure.
7-Warranty Our company warrants 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.
9-EMC Declaration 1)This equipment needs to be installed and put into service inaccordance 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.
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Guidance and manufacture’s declaration – electromagnetic immunity The Infrared Body Thermometeris intended for use in the electromagnetic environment speci�ied below. The customer or the user of Infrared Body Thermome- ter should assure that it is used in such an environment. Anti-interference IEC 60601-1 test level Compliance level...
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Guidance and manufacture’s declaration – electromagnetic immunity The Infrared Body Thermometer is intended for use in the electromagnetic environment speci�ied below. The customer or the user of the Infrared Body Thermometer should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level...
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Guidance and manufacturer's declaration RF wireless communication equipment immunity Test Maximum IMMUNITY Band Service Modulation Distance frequency power TEST LEVEL (V/m) (MHz) (MHz) Pulse modulation 380 - 390 TETRA 400 18 Hz GMRS 460, ± 5 kHz deviation FRS 460 1 kHz sine Pulse LTE Band...
10-Body temperature For consumer use only, not for professional use. ●Body temperature varies from person to person and �luctuates during the course of the day. For this reason, it is suggested to know one's normal, healthy ear temperature to correctly determine the temperature.
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Add:Room 801, 802, 803, 804,901, 2# Building Scientific Research Center, Songhu Intelligent Valley, No.6 Minfu Road, Liaobu Town, Dongguan City, Guangdong Province, P.R.China...
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