Hetaida HTD8813 User manual

Company Name: Wellkang Ltd
Company Address: 16 Castle St, Dover, CT16 1PW, UK
Tel: [phone]
Fax: [phone]
Web: www.CEmark.com, www.CE-marking.com, www.CE-marking.eu,
Email: [email protected]
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.
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 speci�ications 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.
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 certi�ied by noti�ied 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 �irst before using it, if not fully understand the usages, please
stop using the thermometer.
Foreword
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.
Do not operate any of the models HTD8813 thermometer without completely
reading and understanding these instructions.
Hetaida Technology Co., Ltd.
Adds: 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area, DaLingShan Town,
DongGuan City, Guangdong, China.
Tel: [phone]
Fax: [phone]
Contact: Tom. Chen
E-mail: [email protected]
For further information contact:
Safety Information
Warning
Warnings are identi�ied by the WARNING symbol shown above.
Catalogue
Safety Information 3
1- Overview 5
2- Operation 10
3-Troubleshooting 14
4-Replacing the Battery 15
5-Cleaning, Care and Storage 16
6-Disposal 16
7-Warranty 17
8-EMC Declaration 18
9-Body temperature 22
Software version : V31
Ver. NO. A.7
Ver. Date:2020.9.30

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 �ingers.
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 �ield or strong magnetic �ields, 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
Speci�ications’ 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.
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.
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
Intended Use
Thermometer Applications
Equipment Symbols
Description of Non Contact Infrared Body Thermometer
1- Overview
Thermometer
Model Number Thermometer Style Adult
Ear Forehead Ear Forehead
Pediatric
HTD8813
Warning
Non sterile packaging
Consult instructions for use
Operating Temperature
Operating Humidity
Manufacturer
Recyclable
Authorized Representative in the
European community
Serial number
Compliance with WEEE Standard
DO NOT THROW AWAY
Intended for multiple use
Operating atmospheric pressure
Restriction of Hazardous Substances
Batch code
Non Contact Infrared Body Thermometers
40
This device compiles with Part 15
of FCC(Federal Communications
Commission) Rules.
IP22: The �irst number 2: Protected against solid foreign objects of Ф 12.5 mm and
greater. The second number: Protected against vertically falling water drops when
enclosure titled up to 15 
Indicates this device is in compliance
with MDD 93/42/EEC. 0598 is the
Noti�ied Body Number

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.

3- Troubleshooting 4-Replacing the Battery
Warning
Do not recharge, disassemble or dispose of in �ire.
Mode conversion
Recalling and Erasing Memory Data
Parameter settings
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.
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 con�irm 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 �inally 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 con�irm 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.
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).
The last temperature taken before the thermometer powers off is stored in
memory, up to 50.
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
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 completelyconds after the long beep, which
means that all stored data is cleared completely.
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.
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.
Measured over the distance:1-5cm (0.4-2in)
Incorrect test position. See �igure 2 Measuring position and distance.
Optimum measurement distance is 1cm
MESSAGE SITUATION SOLUTION
Temperature taken in not within Typical
human temperature range.
(34.0~43.0℃ or 93.2℉~109.4℉).
Subjects forehead hair, Antipyretic stickers,
head with sweat, etc.
Some people's body temperature is lower
than the general population.
Operating temperature exceeds the range of
speci�ied temperature.
The screen �licker, automatic turn off.
Battery capacity is too low. Taking
Temperature is not allowed.
(1) Power is off.
(2) Improper battery installation.
(3)The battery is exhausted.
(4)Display remains blank.
(1)Press ON button again.
(2)Check the battery polarity.
(3)Replace with a new battery.
(4)Contact the retailer or service center.
Ambient temperature changes too fast Wait until the ambient temperature
is stably.
Install a new battery
Replace battery or the product has been
damaged, needs repairs.
Move to a room within the operating range
wait 30 minutes before taking temperature.
The main concern fever temperature
Subjects sit quietly 5-10 minutes before the
test.
Make sure the forehead thermometer is
for forehead measurement, not other
human body site.

5-Cleaning, Care and Storage
6-Disposal
7-Warranty
The lens is very delicate.
It is very important to protect the lens from dirt and damage.
Use a clean, soft cloth to clean the surface of the device and LCD. Do not use
solvents or immerse the device into water or other liquids.
Always keep the thermometer within the storage temperature range (- 20℃to 55
℃or – 4℉to 131℉) and humidity range (≤93% non-condensing).
It is recommended to store the thermometer in a dry location free from dust. Do
not expose the thermometer to direct sunlight, high temperature/ humidity or any
extreme environment, otherwise the function will be reduced.
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℃.
Used batteries should not be disposed of in the household rubbish. Used Batteries
should be deposited at a collection point.
At the end of its life, the appliance should not be disposed of in household rubbish.
Enquire about the options for environment-friendly and appropriate disposal. Take
local regulations into account.
Our company warrants Non Contact 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:
When asked to provide warranty service, you must have a purchase date and
purchase stamp dealers (including dealers name and address) of the warranty card.
Be sure to ask the dealer to purchase this product signature on the warranty card.
When asked to provide warranty service, please put the product to get our
distribution points for repair. Products outside the warranty expires, will be charged
accordingly.
The device series number label is torn off or cannot be recognized.
Damage to the device resulting from misconnection with other devices.
Damage to the device resulting from accidents.
Changes performed by users without the prior written authorization of the company.
Batteries and packaging are not covered under warranty
1. If you have any problems with this device, such as setting up, maintaining or using,
please contact with SERVICE PERSONNEL of HeTaiDa Technology Co., Ltd. Don’t open
or repair the device by yourself.
2. Please report to HeTaiDa Technology Co., Ltd. if any unexpected operation or
events occur.
3.
4. The patient is an intended operator. The patient can measure and change battery.
Under normal circumstances and maintain the device and its accessories according
to the user manual.
1) This equipment needs to be installed and put into service in accordance 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.
2)* Caution: Do not use a mobile phone or other devices that emit electromagnetic
�ields, near the unit. This may result in incorrect operation of the unit.
3) *Caution: This unit has been thoroughly tested and inspected to assure proper
performance and operation!
4) * Caution: this machine should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, this machine should be
observed to verify normal operation in the con�iguration in which it will be used.
Note:
Guidance and manufacture’s declaration – electromagnetic emission
Guidance and manufacture’s declaration – electromagnetic immunity
Anti-interference detection IEC 60601 test level Compliance level
Emission test Compliance
The Infrared Body Thermometer is intended for use in the electromagnetic environment speci�ied below. The
customer of the user of theInfrared Body Thermometer should assure that it is used in such an environment.
The Infrared Body Thermometeris intended for use in the electromagnetic environment speci�ied below. The
customer or the user of Infrared Body Thermometer should assure that it is used in such an environment.
RF emissions
CISPR 11
RF emission CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage �luctuations/
�licker emissions
IEC 61000-3-3
Group 1
Class B
Not applicable
Not applicable
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage
interruption
IEC 61000-4-11
Power frequency
(50Hz/60Hz)
magnetic �ield IEC
61000-4-8
250 (50Hz)/300 (60Hz) cycles
for >95% UT (sync angle
(degrees):0)
30A/m 30A/m
Voltage dips
IEC 61000-4-11
0.5 cycles for > 95% (sync
angle (degrees):0, 45, 90,
135, 180,225, 270, 315)
1 cycles for >95% UT (sync
angle (degrees):0)
25 (50Hz)/30 (60Hz) cycles
for 30% U T (sync angle
(degrees):0)
The input a.c. power ports: ±2 KV
The input d.c. power ports: ±2 KV
Signal input/output ports: ±1 KV
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Contact: +8 KV
Air: ±2, ±4, ±8, ±15 KV
Contact: +8 KV
Air: ±2, ±4, ±8, ±15 KV
Not applicable
Not applicable
NOTE UT is the a.c. mains voltage prior to application of the test level.
Not applicable
8-EMC Declaration

Guidance and manufacture’s declaration – electromagnetic immunity
Immunity test IEC 60601 test level
Not applicable
Compliance level
The Infrared Body Thermometer is intended for use in the electromagnetic environment speci�ied below. The
customer or the user ofthe Infrared Body Thermometer should assure that it is used in such an environment.
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
Radiated RF
IEC 61000-4-3
Professional healthcare
environment: 3 V/m
Home healthcare
environment: 10 Vm
80 MHz to 2700 MHz
Professional healthcare
environment: 3 V/m
Home healthcare
environment: 10 Vm
80 MHz to 2700 MHz
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and re�lection from structures, objects and people.
a Field strengths from �ixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to �ixed RF transmitters, an electromagnetic site survey
should be considered. If the measured �ield strength in the location in which the Non Contact Infrared Body
Thermometer is used exceeds the applicable RF compliance level above, the Non Contact Infrared Body
Thermometer should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the Non Contact Infrared Body Thermometer.
b Over the frequency range 150 kHz to 80 MHz, �ield strengths should be less than 3 V/m.
9-Body temperature
● 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 forehead
temperature to correctly determine the temperature.
● Body temperature runs approximately from 35.5℃ to 37.8℃(95.9°F-100°F). To
determine if one has a fever, compare the temperature detected with the person's
normal temperature. A rise over the reference body temperature of 1℃(1°F) or more
is generally indication of fever.
●Different measurement sites(rectal, axillary, oral, frontal, auricular) will give
different readings. Therefore it is wrong to compare the measurement taken from
different sites.
●Here below are typical temperatures for adults, based on different measurement
sites:
-Rectal: 36.6℃ to 38℃/97.9°F-100.4°F
-Axillary: 34.7℃ to 37.3℃/94.5°F-99.1°F
ASTM laboratory accuracy requirements in the display range of 37℃ to 38.9℃(98°F
to 102°F) for IR thermometers is ±0.2℃(±0.4°F), whereas for mercury in-glass and
electronic thermometers, the requirement per ASTM Standards E667-86 and
E1112-86 is ±0.1℃(±0.2°F).
Caution: This infrared thermometer meets requirements established in ASTM
Standard (E1965-98) Except of clause 5.2.2. It displays subject’s temperature over a
range of 34.0~43.0℃. Full responsibility for the conformance of this product to the
standard is assumed by(Hetaida Technology Co., Ltd. Add: 4F, Baishida High-Tech
Park, Xiangdong Industrial Area, Dalingshan Town, Dongguan City, Guangdong, China)
Guidance and manufacturer's declaration - RF wireless communication equipment immunity
Test
frequency
(MHz)
Band a)
(MHz)
Service a) Modulation b) Maximum
power
(W)
Distance
(m)
IMMUNITY
TEST LEVEL
(V/m)
385 380 - 390 TETRA 400
Pulse
modulation b)
18 Hz
1,8 0,3 27
450 430 - 470
GMRS 460,
FRS 460
FM c)
± 5 kHz deviation
1 kHz sine
2 0,3 28
710
704 - 787
LTE Band 13,
17
Pulse
modulation b)
217 Hz
0,2 0,3
9745
780
810
800 - 960
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18 Hz
2
0,3
28
870
930
1720
1700 -
1990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
Pulse
modulation b)
217 Hz
2 0,3 28
1845
1970
2450
2400 -
2570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Pulse
modulation b)
217 Hz
2 0,3 28
5240
5100 -
5800
WLAN 802.11
a/n
Pulse
modulation b)
217 Hz
0,2 0,3 9
5500
5785
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not
represent actual modulation, it would be worst case.