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Cat. No 613
Model: HTD8813
Instrution date: 25.01.2021
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Non contact infrared body thermometer
Termometr bezdotykowy
Електронен безконтактен термометър
Bezdotykový infračervený teploměr
Kontaktloser elektronischer thermometer
Termómetro electrónico sin contacto
Thermomètre électronique sans contact
Θερμόμετρο υπερύθρων ανέπαφης μέτρησης
θερμοκρασίας σώματος
Érintésmentes infravörös hőmérő
Elektroninis bekontaktis termometras
Elektroniskais bezkontakta termometrs
Contactloze infrarood lichaamsthermometer
Termômetro de corpo infravermelho sem contato
Termometru digital non-contact
Термометр электронный бесконтактный
Beröringsfri infraröd termometer
Bezdotykový infračervený teplomer
Термометр електронний безконтактний
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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 certied by notied 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 rst before using it, if not fully
understand the usages, please stop using the thermometer. Do not operate any of the Model HTD8813 thermometer
without completely reading and understanding these instructions.
1. GENERAL INFORMATION
INTENDED USE
The 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 THE NON-CONTACT INFRA-RED THERMOMETER
The Babyono non-contact infrared-red thermometer is a manual, battery-powered device for measuring human body temperature (on the
forehead). The device uses an infrared-red sensor to measure the temperature. The IR sensor generates various signals when measuring
temperatures of dierent objects or when placed in ambient with varying temperature. The ASIC transforms the infra-red signal into a digital
value and shows on the device’s LCD display.
DESCRIPTION OF CONTROL ELEMENTS, INDICATORS AND SYMBOLS
Fig. 1: infrared-red thermometer, part no. 613
1. LCD display
2. Battery cover
3. On / O
4. SET button
5. MEMO button
6. MODE button
7. IR sensor
8. Surface temperature measurement mode
9. Body temperature measurement mode
10. Readout
11. Result indicator
12. Low battery indicator
13. Sound on / o indicator
14. Saved readout number
15. Fahrenheit degrees
16. Celsius degrees
17. Memory indicator
EN Non contact infrared body
thermometer
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TECHNICAL SPECIFICATION
Measuring unit °C / °F
Operating mode Adjusted mode (body mode)
Direct mode (surface temperature) Direct mode(surface mode)
Measuring site Forehead
Reference Body Site Axillary
Rated output range Body mode: 34,0 °C ~ 43,0 °C / 93,2 °F ~ 109,4 °F
Surface mode: 0 °C ~ 100 °C / 32 °F ~ 212 °F
Output Range Body mode:34.0°C ~ 43.0 °C/ 93.2 °F - 109.4 °F
Surface mode: 0 °C ~ 100.0 °C / 32°F - 212 °F
Laboratory Accuracy Body mode:
34.0 °C ~ 34.9 °C ± 0.3 °C/ 93.2 °F - 94.8 °F ± 0.5 °F
35.0 °C ~ 42.0 °C ± 0.2 °C / 95.0 °F - 107.6 °F ± 0.4 °F
42.1 °C ~ 43.0 °C ± 0.3 °C / 107.8 °F - 109.4 °F ± 0.5 °F
Surface mode:
± 2 °C / ± 3.6 °F
Display resolution 0,1 °C / 0,1 °F
Three-colour backlight
(colour codes) 35.5 °C - 37.3 °C / 95.9 °F - 99,1 °F Green (normal temperature);
37.4 °C - 38.0 °C (alarm point) / 99,3 °F - 100.4 °F Yellow (slight fever)
38.1 °C - 43.0 °C / 100.6 °F - 109.4 °F Red (high fever)
Caution:
1. The colour codes only work in body temperature measuring mode.
2. The backlight is always green when measuring the temperature of surfaces.
3. In body mode 34.0-35.4°C is with green backlight.
Automatic power off time ≤ 18 s
Measuring time ≤ 2 s
Measuring distance 1 cm - 5 cm
Memory slots 50
Power supply requirements
Batteries 1.5 V (AAA) alkaline x 2 (IEC Type LR03)
Operating voltage range 2.6 V ~ 3.6 V
Ambient conditions
Operating conditions Operating temperature: 15 °C ~ 40 °C (59 °F ~ 104 °F),
relative humidity ≤ 85%, atmospheric pressure: 70 kPa -106 kPa
Transport and storage conditions Storage temperature: - 20 °C to + 55 °C / - 4 °F to + 131 °F,
relative humidity ≤ 93%, atmospheric pressure: 70 kPa - 106 Pa
Dimensions and weight
Weight (w/o batteries) 90 g
Dimensions L: 138 mm X W: 95 mm X H: 40 mm
Compliance
Item Compliance with
Device classification Safety standard EN 60601-1: 2006+A1:2013, EN 60601-1-2: 2015
Protection type Internally (battery) powered equipment
Type of protection Internally powerd 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
Safety classification of ME EQUIPMENT
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
Note: Not intended to be sterillized. Not for use in an OXYGEN RICK ENVIRONMENT
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CALCULATED VALUES OF THE INDICATORS ACCORDING TO ISO 80601-2-56
Forehead mode:
Group A1 Group A2 Group B Group C
Bias 0,015 0,0000 -0,042 -0,040
Standard Deviation 0,123 0,121 0,121 0,137
Limits of Agreement 0,245 0,243 0,243 0,274
Clinical Repeatability (for All Group) 0,071
Note: the above value is calculated from clinical data of HTD8818A
2 - OPERATION
2.1 BATTERY INSTALLATION
Caution: A non-contact infrared body thermometer with discharged batteries will not operate. New batteries must be installed in such a case.
1) Pull down and open the battery cover in the thermometer’s bottom part.
2) Place two AAA batteries inside, observing the “+” and “-” polarity marks.
3) Close the battery cover.
2.2 OPERATING METHOD
Please read the warnings in the manual before operating the device.
• To measure human body temperature, aim the thermometer at the middle of the forehead, (between the eyebrows above) maintain the
distance and press the On/O button - the measurement will take place immediately.
• The ambient temperature where the device is being used should be stable - do not approach large ventilators, AC vents, etc.
• When moving from a place with lower ambient temperature to a place with a higher temperature, remain for at least 5 minutes in the new
place to allow the temperatures to balance out.
• Wait at least 1 second between measurements. When taking 5 (or more) consecutive measurements, wait at least 30 seconds between
such series.
• The green backlight means the device is ready to use. The yellow backlit range of temperatures from 37.4 °C to 38,0 °C means slight fever
warning. Please take relevant steps if this body temperature is in this range. The red backlit temperature of over 38.1 °C means a fever. Please
take relevant steps to lower body temperature or consult a doctor.
• Do not use the thermometer in places with excessive sunlight.
• If the measurement taken on the forehead is too low, measure the temperature behind the ear.
2.3 GENERAL CONFIGURATION AND OPERATION
• Starting the measurement
1. Use the On / O button to activate the thermometer. After activation, the thermometer will take 2 seconds to perform a self-test.
2. Aim the thermometer at the forehead of the examined person, maintain the distance, press the On / O button to measure the
temperature and read the value on the LCD display.
Caution: 1) Once the display is o, the device makes a beep to signal the end of the measurement. At the same time, the LCD display will show
the measured value and the background will highlight in either red, yellow or green.
2) To ensure accurate measurements, wait 30 seconds between making sets of ve consecutive measurements.
• Selecting the operating mode
After activating the device, press the MODE button to select the body temperature measurement mode or the surface temperature
measurement mode.
The body temperature measurement mode is for measuring the temperature of human body and the surface temperature measurement
mode serves to measure the temperature of objects. (By default, the device operates in the body temperature measurement mode).
• Restoring and deleting the saved data
The 50-cell memory stores the result of the last measurement taken before deactivating the thermometer.
1) To display the stored measurements, briey press the MEMO button when the devices is being activated or deactivated.
2) An empty memory cell shows “---°C” or “---°F”.
3) The measured results can be stored in the device’s memory. The memory can store 50 results and once all cells are used, the oldest result
is replaced with the latest result.
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4) To fully wipe the memory, press the MEMO button when the devices is being activated and keep it depressed, until “CLR” is shown on
the LCD display.
2.4 CONFIGURING THE PARAMETERS
To satisfy the needs of various groups of patients or individual patients, the device’s colour codes can be customized.
To modify measurement parameters, press and keep depressed the SET button.
1) Selecting the measuring units - F1
When the device is being activated, press and keep depressed the SET button, then select F1, press and keep depressed the MODE button
to switch between Celsius and Fahrenheit degrees, and then press the SET button to conrm the selection (Celsius degrees are selected
by default).
2) Light fever alarm - F2
After selecting F1, press the SET button to go to F2, then press the MODE button to decrease the value by 0.1 °C, or press the MEMO button
to increase the value by 0.1 °C; to adjust the value more quickly, press and keep the relevant button depressed, then press the SET button to
save the selected value. (The default value is 38.1 °C)
3) Changing sound signals - F3
After selecting F2, briey press the SET button to go to F3, then press the MODE button or the MEMO button to change the sound signal, and
then press the SET button to conrm the new setting. (By default, there is a sound signal when the device is being activated).
4) Exiting the conguration mode
After selecting F3, press the SET button to deactivate the LCD display and leave the settings menu.
• Activating and deactivating the sound signal
When the device is being activated, briey press the SET button to turn the sound signal on or o.
• Restoring default settings
When the device is being activated, press and keep depressed the MODE button, until “rst” is shown on the LCD display. After 2 seconds, the
defaults settings for positions F1 - F3 will be restored.