Hetaida HTD8808E User manual

Technical File
File No. ZHTF-CE-01-015
Rev. No. A.5
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date 2020-07-10
Page 1 / 24
HeTaiDa
Non Contact Infrared Body
Thermometer
User Manual
Model: HTD8808E
ware version : V31

Technical File
File No. ZHTF-CE-01-015
Rev. No. A.5
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date 2020-07-10
Page 2 / 19
2
Foreword
The non contact Infrared body thermometer operating Instructions intend to provide the
necessary information for proper operation of HTD8808E thermometer model.
Only body mode was reviewed and certified by notified body.
General knowledge of Infrared thermometer and an understanding of the features and
functions of the HTD8808E thermometer model are prerequisites for proper use.
The non contact infrared body thermometer is amedical device, and can be used
repeatedly, which using life is 5 years.
Please readthe manual first before using it, if notfully understand the usages, please st
op using thethermometer.
Do not operate any of the models HTD8808E thermometer without completely
reading and understanding these instructions.
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 relatingpatents.
For further information contact:
Hetaida Technology Co., Ltd.
Adds: Room 801, 802,803,804,901, 2# Building Scientific Research Center, Songhu lntelligent Valley,
No.6 Minfu Road, Liaobu Town, Dongguan City, Guangdong Province,P.R.China
Tel: [phone]
Fax: [phone]
0598
Contact: Tom. Chen
E-mail: [e-mail]
About this manual edition
Current Updated Edition/Revision: A.5, July 10, 2020;
Safety Information
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.
Company Name: Share Info Consultant Service LLC Repräsentanzbüro
Company Address: Heerdter Lohweg 83, 40549 Düsseldorf
Tel: [phone]
Fax: [phone]
Email: [email protected]; [email protected];

Technical File
File No. ZHTF-CE-01-015
Rev. No. A.5
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date 2020-07-10
Page 3 / 19
3
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.
Warning
Warnings are identified by the WARNING symbol shown above.
The Non Contact 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 specifications should be read
before use.
This product is designed to measure human body temperature on the forehead. Do
not use it forany other purpose.
This product is intended in the home setting and primary care setting as screening
tool.
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 sensorof infrared detection with your fingers.
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 usingaccordancewith the "Care and Storage" sectionto removingthe fog.
Do not near strong electrostatic field or strong magnetic fields, 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.

Technical File
File No. ZHTF-CE-01-015
Rev. No. A.5
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date 2020-07-10
Page 4 / 19
4
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 fire.
Only use recommendedbatteries. 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
Specifications’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.

Technical File
File No. ZHTF-CE-01-015
Rev. No. A.5
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date 2020-07-10
Page 5 / 19
5
Section 1- Overview
Intended Use
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.
Description of Non Contact Infrared Body Thermometer
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
4.
Figure 1: HTD8808E Infrared body thermometer
1. IR sensor
2. Liquid crystal display(LCD)
3. MODE bu on
4. Down Arrow
5. Up Arrow bu on
6. Set
7. ON/measure
8. Cover
9. Surface mode
10. Body mode
11. Data indicator
12. Indicator of measurement result
13. Low Ba ery indicator
14. Volume on/o indicator
15. Fahrenheit
16. Memory Number
17.Celsius
18.Memory indicator
19
.Bluetooth
indicator
20
20.Data transmission line

Technical File
File No. ZHTF-CE-01-015
Rev. No. A.5
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date 2020-07-10
Page 6 / 19
6
Thermometer Applications
Thermomete
r
Model
Number
Thermometer
Style
Adult Pediatric
EarForehea
d
Ea
r
Forehea
d
HTD8808E Non Contact Infrared Body
Thermometers
Equipment Symbols
WarningOperating atmospheric
pressure
Non sterile packaging
Refer to operating
instructions
Compliance with WEEE
Standard
Operating
Temperature
DO NOT THROW AWAY
Intended for multiple use
Operating Humidity
Indicates this device is in
compliance with MDD
93/42/EEC. 0598 is the
Notified Body Number
This device compiles
with Part 15 of
FCC( Federal
Communications
Commission) Rules.
Restriction of Hazardous
Substances
Manufacturer
Authorized
Representative in the
European community
Recyclable Serial number
IP22
IP22: The first number
2: Protected against
solid foreignobjects of
12.5 mm and greater.
The second number:
Batch code

Technical File
File No. ZHTF-CE-01-015
Rev. No. A.5
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date 2020-07-10
Page 7 / 19
7
Protected against
vertically falling water
drops when enclosure
titled up to 15º.
Technical Specifications
Measurement Unit /
Operating mode Adjusted mode(Body mode)
Direct mode(surface mode)
Reference Body Site Axillary
Rated output range Body mode: 34.0 ~43.0 /93.2°F -109.4°F
Surface mode: 0~100/32~212
Output Range Body mode:34.0 ~43.0/ 93.2°F -109.4°F
Surface mode: 0~100.0 / 32°F -212°F
Laboratory Accuracy
Body mode:
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;
Surface mode:
±2 /±3.6°F.
Display Resolution 0.1/0.1
Three-color Backlight
(Color Alarm)
35.5-37.3°C / 95.9-99.1°F: Green (Normal Temperature);
37.4-38.0°C(Alarm point) / 99.3-100.4°F: Yellow (Slight
Fever)
38.1-43.0°C / 100.6-109.4°F: Red(High Fever)
Note: 1.Surface mode is always with Green backlight.
2. In body mode 34.0-35.4°C is with green backlight.
Auto Power Off Time HTD8808E 18s
Measuring Time 2S
Measuring Distance HTD8808E: 0.1CM -15CM(0.04 in -5.9in)
Memories HTD8808E 50
Power Supply
Requirements
Power 1.5V (AAA) Alkaline batteryX2 (IEC Type LR03)or DC 5V(MicroUSB)
Adaptable Range 2.6V~3.6V
Environmental

Technical File
File No. ZHTF-CE-01-015
Rev. No. A.5
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date 2020-07-10
Page 8 / 19
8
Operating Condition
HTD8808E:
Operating Temperature:15 ~40 (59°F ~104°F) Relative
Humidity 85%,atmospheric pressure:70 Kpa -106Kpa
Transport and Storage
Condition
HTD8808E
Storage Temperature:-20°C -55°C / -4 °F - 131°F, Relative
Humidity 93%,atmospheric pressure:70 Kpa -106Kpa
Dimension and Weighting
Weight (without batteries) HTD8808E: 116g
SizeHTD8808E: L:150mm XW:95mm X H:44mm
Compliance
tnailpmoCmetI with
Equipment classification 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
environmentEN 60601-1-11:2015
Calculated values of the indicators according to ISO 80601-2-56
detaluclaCsrotacidnI value
Clinical bias, cb 720.0-
Standard deviation, j0.14
Limits of agreement, LA0.26
Clinical repeatability, r0.07
Note: the above value is calculatedfrom clinical data of HTD8818A.
Safety classification of ME EQUIPMENT
Protection against electric shock Internally powered ME
equipment

Technical File
File No. ZHTF-CE-01-015
Rev. No. A.5
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date 2020-07-10
Page 9 / 19
9
2- Operation
2.1 Battery installation
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 AAAsize batteries according to the “+” and “-”;
3) Close the battery cover.
2.2 How to Operate
Before Applying the Thermometer
Be sure to read and understand all warnings listed of the instructions before use.
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/Scan button, temperature display immediately, see figure 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 flow 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
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 sterilized. Not for use in an OXYGEN RICH ENVIRONMENT
Figure2 Measuring posi�on and distance

Technical File
File No. ZHTF-CE-01-015
Rev. No. A.5
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date 2020-07-10
Page 10 / 19
10
minutes, to be consistent with the ambient temperature after the
re-measurement.
Wait at least 1 second for the next measurement. If the continuous
measurement of five 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 figure 3.
General Setup and Use
Start measuring
1. Turn on the thermometer by pressing the On/Scan 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/Scan
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 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.
Mode conversion
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).
Figure 3 Align behind the ears to measurement

Technical File
File No. ZHTF-CE-01-015
Rev. No. A.5
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date 2020-07-10
Page 11 / 19
11
Recalling and Erasing Memory Data
The last temperature taken before the thermometer powers off is stored in
memory, up to 50 for HTD8808E.
HTD8808Eas below step:
1) In the boot or shutdown state, short press the down""function key, or
press the up" "function key toview 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 bootmode, press the up "" or down " " button multifunction key
until the LCD display "CLR", about two seconds after the long beep, which
means that all stored data is cleared completely.
Parameter settings
This productcan be set according tothe subjects of differentcolors and
different environments data to meet the different characteristics of populations
or individuals.
HTD8808Eas below step:
1) Unit Set-F1
Under the boot mode .Long press SET button to enter F1, press the
up"" or down “ ”arrow keys to switch Celsius and Fahrenheit
temperature units, press the SET button to confirm the unit settings
(factory default is Celsius).
2) Fever alert set-F2
Under F1 state ,Press SET key to enter the F2, press the down“”key
to decrease 0.1 , press the up""key plus 0.1 , long press to
accelerate the speed of temperature regulation, and finally press the SET
button to save. (The factory default is 38.1 )
3) Prompt sound settings-F3
Under F2 state ,short press SET key to enter F3, press the down“”key
or the voice Prompt to set up" "key switch, and press the SET button to
confirm the settings. (The factory default is the voice Prompt to open).
4) Exit setting mode
In the F3 mode, press the SET button will automatically turn off the
screen, exit setting.
Prompt sound settings ON/OFF function
HTD8808E

Technical File
File No. ZHTF-CE-01-015
Rev. No. A.5
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date 2020-07-10
Page 12 / 19
12
Under the boot mode .Short press SET button to take on or take off the
Prompt sound function.
Restore to factory setting function
HTD8808E
Under the boot mode, long press MODE button until LCD display “rst”. Two
secondslater ,former F1-F3 parameter back to factory setting.
Data transfer function
Terminal equipment requirements:
a) Android system: version 4.3 or above;
b) IOS system: 8.0.0 or above;
c) Computer system: Windows XP or above;
d) Data receiving and processingsoftware;
e) hardware: support Bluetooth 4.0 BLE.
3- Troubleshooting
MESSAGE SITUATION SOLUTION
Temperature taken in not within
Typical human temperature range.
(34.0~43.0 or 93.2 ~109.4 ).
Make sure the forehead
thermometer is for forehead
measurement, not other
human body site.
Measured over the distance
HTD8808E 0.1-15cm
(0.04-5.9in)
Optimum measurement
distance is 1cm.
Incorrect test position. See figure 5 Measuring
position and distance.
Subjects forehead hair,
Antipyretic stickers, head with
sweat, etc.
Subjects sit quietly 5-10
minutes before the test.
Some people's body
temperature is lower than the
general population.
The main concern fever
temperature
Operating temperature exceeds
the range of specified
temperature.
Move to a room within the
operating range wait 30 minutes
before taking temperature.

Technical File
File No. ZHTF-CE-01-015
Rev. No. A.5
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date 2020-07-10
Page 13 / 19
13
The screen flicker, automatic
turn off.
Replace battery or the product has
been damaged, needs repairs.
Battery capacity is too low. Taking
Temperature is not allowed.
Install a new battery
Ambient temperature changes too
fast
Wait until the ambient temperature
is stably.
(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.
4-Replacing the Battery
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 .
4. Slide the battery cover back in until it snaps in place.
Do not dispose of used batteries in household waste. Takethem to special local
collection sites.
5. 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.
Warning
Do not recharge, disassembleor dispose of in fire.
1.The typical servicelifeof 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.
-Cleaning, Care and Storage
The lens is very delicate.
It is very important to protect the lens from dirt and damage.

Technical File
File No. ZHTF-CE-01-015
Rev. No. A.5
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date 2020-07-10
Page 14 / 19
14
Use a clean, soft cloth to clean the surface of the device and LCD. Do not use
solvents or immersethe device into water or other liquids.
Always keep the thermometer a within the storage temperature and humidity range
as specified.
It is recommended to store the thermometer in a dry location free from dust.
Always keep the thermometer within the storage temperature range (- 20 to
55 or – 4to 131 ) and humidity range ( 93% non-condensing) forHTD8808E.
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 .
-Disposal
1) Used batteries should not be disposed of in the household rubbish. Used Batteries
should be deposited at a collection point.
2) 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.
-Warranty
Our company warrants Non Contact Infrared Body Thermometer at the time of its
original purchase and forthe 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.
Damage to the device resulting from accidents.
Changes performed by users without the prior written authorization of the company.
Batteries and packagingare not covered under warranty
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.
Note:
1. If you have any problems with this device, suchas 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.

Technical File
File No. ZHTF-CE-01-015
Rev. No. A.5
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date 2020-07-10
Page 15 / 19
15
3.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.
8Calibration
The thermometer is initially calibrated at the time of manufacture. If this thermometer is
used according to the use instructions, periodic re-adjustment is not required. If at any
time you question the accuracy of temperature measurements, please contact us timely.
EMC Declaration
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 fields,
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 configuration in which it will be used.
Guidance and manufacture’s declaration – electromagnetic emission
The Infrared Body Thermometer is intended for use in the electromagnetic environment specified below. The
customer of the user of theInfrared Body Thermometer should assure that it is used in such an environment.
Emission test Compliance
RF emissions
CISPR 11
Group 1
RF emission
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Not applicable

Technical File
File No. ZHTF-CE-01-015
Rev. No. A.5
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date 2020-07-10
Page 16 / 19
16
Guidance and manufacture’s declaration – electromagnetic immunity
The Infrared Body Thermometeris intended for use in the electromagnetic environment specified below. The customer or
the user of Infrared Body Thermometer should assure that it is used in such an environment.
Anti-interference
detection IEC 60601-1 test level Compliance level
Electrostatic discharge
(ESD)
IEC 61000-4-2
Contact: +8 KV
Air: +2,+4,+8,+15 KV
Same as the left
Electrical fast
transient/burst
IEC 61000-4-4
The input a.c. power ports: ±2 KV
The input d.c. power ports: ±2 KV
Signal input/output ports: ±1 KV
Not applicable
Surge
IEC 61000-4-5
Input power ports: +0.5, +1.0 KV
Signal input/output:+2.0 KV
Not applicable
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)
Not applicable
Voltage interruption
IEC 61000-4-11
250 (50Hz)/300 (60Hz) cycles for >95% UT (sync
angle (degrees):0)
Power frequency
(50Hz/60Hz) magnetic
field IEC 61000-4-8
30A/m Same as the left
NOTE U
T
is the a.c. mains voltage prior to application of the test level.

Technical File
File No. ZHTF-CE-01-015
Rev. No. A.5
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date 2020-07-10
Page 17 / 19
17
Guidance and manufacture’s declaration – electromagnetic immunity
The Infrared Body Thermometer is intended for use in the electromagnetic environment specified below.
The customer or the user ofthe Infrared Body Thermometer should assure that it is used in such an
environment.
Immunity test IEC 60601 test level Compliance level
Conducted RF
IEC 61000-4-6
3 V
rms
150 kHz to 80 MHz Not applicable
Same as the left.
Radiated RF
IEC 61000-4-3
Professional healthcare
environment: 3 V/m
Home healthcare
environment: 10 Vm
80 MHz to 2700 MHz
NOTE 1 At 80 MHzand 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situaons. Electromagnec propaga is aected by absorp and
reecon from structures, objects and people.
a Field strengths from xed transmiers, such as base staons for radio (cellular/cordless) telephones and landmobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theorecallywith accuracy. To assessthe
electromagnec environment due to xed RF transmiers, an electromagnec sitesurvey should be considered. If the
measured  strength in the locan in which theInfrared Body Thermometer is used exceeds the applicable RF compliance
level above, the Infrared Body Thermometer shouldbe observed to verify normal oper If abnormal performance is
observed,  measures may benecessary, such as re orieng or relocang the Infrared Body Thermometer.
b Over the frequency range 150 kHz to 80 MHz,  strengths should be less than 3V/m.

Technical File
File No. ZHTF-CE-01-015
Rev. No. A.5
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date 2020-07-10
Page 18 / 19
18
9- Body temperature
Body temperature varies from person to person and fluctuates 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-99.1°F
-Axillary: 34.7 to 37.3 /94.5°F-99.1°F

Technical File
File No. ZHTF-CE-01-015
Rev. No. A.5
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date 2020-07-10
Page 19 / 19
19
ASTM laboratory accuracy requirements in the display range of 37 (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 conformanceof this product to the standard is
assumed by (Hetaida Technology Co., Ltd. Adds: Room 801, 802,803,804,901, 2#
Building Scientific Research Center, Songhu lntelligent Valley, No.6 Minfu Road,
Liaobu Town, Dongguan City, Guangdong Province,P.R.China
10-FCC Regulatory Compliance
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.
changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference in a residential instal-
lation. This equipment generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is no guarantee
that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television reception,
which can be determined by turning the equipment off and on, the user is encour-
aged to try to correct the interference by one or more of the following measures:
-- Reorient or relocate the receiving antenna.
-- Increase the separation between the equipment and receiver.
-- Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
-- Consult the dealer or an experienced radio/TV technician for help.
The device has been evaluated to meet general RF exposure requirement. The
device can be used in portable exposure condition without restriction.
This device and its antenna(s) must not be co-located or operation in conjunction
with any other antenna or transmitter.