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Hetaida HTD8813 - Technical Specifications; Dimension and Weighting; Compliance; Safety Classification of ME EQUIPMENT

Hetaida HTD8813
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Caution: 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.
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 �igure 2.
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-measure-
ment.
Wait at least 1 second for the next measurement. If the continuous measurement
of �ive 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 �igure 3.
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
Technical Speci�ications
2- Operation
Calculated values of the indicators according to ISO 80601-2-56
Before Applying the Thermometer
General Setup and Use
Safety classi�ication of ME EQUIPMENT
2.1Battery installation
2.2How to Operate
Dimension and Weighting
Compliance
Item Compliant with
Weight (without batteries) 90g
Size
Equipment classi�ication Safety Standards: EN 60601-1: 2006+A1:2013, EN 60601-1-2: 2015
Type of protection Internally powered equipment (on battery power)
Degree of protection Non Applied part
Front panel and case labeling EN ISO15223-1:2016
Temperature EN ISO80601-2-56:2017
Home healthcare environment EN 60601-1-11:2015
Forehead mode:
Bias 0.015
Standard Deviation 0.123
Limits of Agreement 0.245
0.000
0.121
0.243
-0.042
0.121
0.243
-0.042
0.137
0.274
Clinical Repeatability(for All Group)
Be sure to read and understand all warnings listed of the instructions before use.
Note: the above value is calculated from clinical data of HTD8818A.
Note: Not intended to be sterilized. Not for use in an OXYGEN RICH ENVIRONMENT
0.071
Group A1 Group A2 Group B Group C
Protection against electric shock Internally powered ME equipment
Applied part Non Applied part
Protection against harmful ingress of water or particulate matter IP22
Mode of operation Continuous operation
L:138mm X W:95mm X H:40mm
Figure 2:Measuring position and distance
Figure 3:Align behind the ears to measurement
Start measuring
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.

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