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PROFESSIONAL MEDICAL PRODUCTS
TERMOMETRO A DISTANZA A INFRAROSSI
NON-CONTACT INFRARED BODY THERMOMETER
THERMOMÈTRE À INFRAROUGES
SANS CONTACT
TERMÓMETRO INFRARROJO
SIN CONTACTO
25583
Modello / Model / Modèle / Modelo: HTD8816C
Hetaida Technology Co., Ltd.
4F, BaiShiDa High-Tech Park, XiangDong
Industrial Area, DaLingShan Town, DongGuan City,
Guangdong, China
Made in China
WellKang Ltd,
16 Castle St, Dover, CT16 1PW Dover,
CT16 1PW, UK
Importato da / Imported by / Importé de / Importado de:
Gima S.p.A.
Via Marconi, 1
20060 Gessate (MI) Italy
M25583-M-Rev.0-04.20
0598
IP22
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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.
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
• The non contact infrared body thermometer is a medical device, and can be used
repeatedly, which using life is 5 years.
• 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 specications 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.
• 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 ngers.
• 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 eld or strong magnetic elds, 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,
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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 re.
- 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 Specications’ 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.
1. Overview
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 Non Contact Infrared Body Thermometer
• Device principle and introduction
The Non contact infrared body thermometer are hand-held, reusable, battery oper-
ated 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
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value and display it on the LCD.
• Description on Controls and Indicators.
1. IR sensor 9. Data indicator
2. Liquid crystal display(LCD) 10. Indicator of measurement result
3. MODE button 11. Low Battery indicator
4. Memo button 12. Voice on/off indicator
5. On/Scan button 13. Memory Number
6. Battery Cover 14. Fahrenheit
7. Surface mode 15. Celsius
8. Body mode 16. Memory indicator
Thermometer Applications
Thermometer Style Adult Pediatric
Ear Forehead Ear Forehead
Non Contact Infrared Body
Thermometers
√ √
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Technical Specications
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
Output Range Body mode: 34.0℃~43.0℃/ 93.2°F -109.4°F
Laboratory Accuracy Body mode:
Surface mode: 0℃~100℃ / 32℉~212℉
Surface mode: 0℃~100.0℃/ 32°F -212°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;
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 ≤18s
Measuring Time ≤2s
Measuring Distance 1 cm -5cm (0.4 in -2in)
Memories 50
Power Supply
Requirements
Batteries 1.5V (AAA) Alkaline battery x2 (IEC Type LR03)
Adaptable Range 2.6V~3.6V
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Environmental
Operating Condition Operating Temperature: 15℃~40℃
Transport and Storage
Condition
(59°F ~104°F),
Relative Humidity ≤85%,
atmospheric pressure:70 Kpa -106 Kpa
Storage Temperature:-20°C -55°C /
(-4°F - 131°F),
Relative Humidity ≤93%,
Atmospheric pressure:70 Kpa -106 Kpa
Dimension and Weighting
Weight (without batteries) 80g
Size L:122mm X W:96mm X H:42mm
Compliance
Item Compliant with
Equipment classication 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
Safety classication 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 sterilized. Not for use in an OXYGEN RICH ENVIRONMENT
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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 AAA size 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 gure 2.
Figure 2-Measuring position and distance
• 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 ow 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-measurement.
• Wait at least 1 second for the next measurement. If the continuous measurement
of ve times, it is recommended to wait at least 30 seconds and then continue
measurement.
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• 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 gure 3.
Figure 3- Align behind the ears
to measurement
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 tem-
perature 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 con-
secutive 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).
Recalling and Erasing Memory Data
The last temperature taken before the thermometer powers off is stored in memory,
up to 50.
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As below step:
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 completely.
Parameter settings
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.
As below step:
1. Unit Set-F1
Under the boot mode, long press the MODE button to enter F1, press the “MODE”
or “MEMO”button to switch Celsius and Fahrenheit temperature units, press the
On/Scan button to conrm the unit settings (factory default is Celsius).
2. Fever alert set-F2
Under F1 state ,press On/Scan button to enter the F2, press the “MODE” button to
plus 0.1℃, press the “MEMO” button decrease 0.1 ℃, long press to accelerate the
speed of temperature regulation, and nally press the On/Scan button to save. (The
factory default is 38.1℃).
3. Prompt sound settings-F3
Under F2 state, press On/Scan button to enter F3, press MODE button or MEMO
button to set voice switch, and press the On/Scan button to conrm the settings.
(The factory default is the voice Prompt to open).
4. Exit setting mode
In the F3 mode, press the On/Scan button will automatically turn off the screen, exit
setting.
Prompt sound settings ON/OFF function
Under the boot mode .Short press power on/off button ,at the same time press the
MODE button to take on or take off the Prompt sound function.
Restore to factory setting function
Under the boot mode .Short press power on/off button ,at the same time press the
MEMO button. Until LCD display “rst”. Two seconds later ,former F1-F3 parameter
back to factory setting.
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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.
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Measured over the distance 1-5
cm (0.4-2in).
Incorrect test position. See gure 2 Measuring position
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 specied
temperature.
The screen icker, automatic
turn off.
Battery capacity is too low.
Taking temperature is not
allowed.
Ambient temperature changes
too fast.
Optimum measurement distance
is 1cm.
and distance.
Subjects sit quietly 5-10 minutes
before the test.
The main concern fever
temperature,
Move to a room within the
operating range wait 30 minutes
before taking temperature.
Replace battery or the product
has been damaged, needs
repairs.
Install a new battery
Wait until the ambient
temperature is stably.
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1) Power is off.
2) Improper battery installation.
3) The battery is exhausted.
4) Display remains blank.
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.
3. Slide the battery cover back in until it snaps in place.
4. Do not dispose of used batteries in household waste. Take them 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, disassemble or dispose of in re.
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.
5. Cleaning, Care and Storage
• 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 a within the storage temperature and humidity range
as specied.
• It is recommended to store the thermometer in a dry location free from dust.
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
1) Press ON button again.
2) Check the battery polarity.
3) Replace with a new battery.
4) Contact the retailer or service
center.
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temperature, allow the thermometer to remain in a room for 30 minutes where the
temperature is between 15℃ to 40℃.
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
elds, 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 conguration in which it will be used.
Guidance and manufacturer’s declaration – electromagnetic emission
The Non Contact Infrared Body Thermometer is intended for use in the electromagnetic
environment specied below. The customer of the user of the Non Contact Infrared Body
Thermometer should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment – guidance
RF emissions CISPR 11 Group 1 The Non Contact Infrared Body Thermome-
RF emission CISPR 11 Class B The Non Contact Infrared Body ThermomeHarmonic emissions
IEC 61000-3-2
Voltage uctuations/ icker
emissions IEC 61000-3-3
Not
applicable
Not
applicable
ter use RF energy only for its internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in nearby electronic equipment.
ter is suitable for use in all establishments,
other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for
domestic purposes.
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Guidance and manufacturer’s declaration – electromagnetic immunity
The Non Contact Infrared Body Thermometer is intended for use in the electromagnetic
environment specied below. The customer or the user of Non Contact Infrared Body Thermometer should assure that it is used in such an environment.
Immunity test IEC 60601 test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50Hz/60Hz)
magnetic eld
IEC 61000-4-8
level
±6 kV contact
±15 kV air
±2 kV for power
supply lines
±1 kV for input/
output lines
± 1 kV line(s)
to line(s)
± 2 kV line(s)
to earth
5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
30A/m 30A/m Power frequency magnetic
Compliance
level
±6 kV contact
±15 kV air
Not
applicable
Not
applicable
Not
applicable
Electromagnetic
environment - guidance
Floors should be wood, con-
crete or ceramic tile. If oor are
covered with synthetic material,
the relative humidity should be
at least 30%.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should
be that of a typical commercial or hospital environment.
If the user of the Non Contact
Infrared Body Thermometer
requires continued operation
during power mains interruptions, it is recommended that
the Non Contact Infrared Body
Thermometer be powered from
an uninterruptible power supply
or a battery.
elds should be at levels characteristic of a typical location in
a typical commercial or hospital
environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
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Guidance and manufacturer’s declaration – electromagnetic immunity
The Non Contact Infrared Body Thermometer is intended for use in the electromagnetic
environment specied below. The customer or the user of the Non Contact Infrared Body
Thermometer should assure that it is used in such an environment.
Immunity test IEC 60601 test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
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 reection from structures, objects and people.
level
3 Vrms
150 kHz to 80
MHz
10V/m
80 MHz
to 2.5 GHz
Compliance
level
Not
applicable
10 V/m
Electromagnetic
environment - guidance
Portable and mobile RF communications equipment should
be used no closer to any part of
the Non Contact Infrared Body
Thermometer, including cables,
than the recommended separation distance calculated from
the equation applicable to the
frequency of the transmitter.
Recommended separation
distance
d= 1.2 √P
d= 1.2 √P
80MHz to 800MHz
d= 2.3 √P
80MHz to 800MHz
Where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer
and d is the recommended separation distance in metres (m).
Field strengths from xed RF
transmitters, as determined
by an electromagnetic site
survey,a should be less than
the compliance level in each
frequency range.
Interference may occur in the
vicinity of equipment
marked with the
following symbol:
b
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a Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld 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, eld strengths should be less than 10 V/m.
Recommended separation distances between portable and mobile RF communications equipment and the Non Contact Infrared Body Thermometer.
The Non Contact Infrared Body Thermometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the
Non Contact Infrared Body Thermometer can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Non Contact Infrared Body Thermometer as recommended below, according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter (W)
0.01 0.12 0.12 0.23
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reection from structures, objects and people.
Separation distance according to frequency of transmitter (m)
150KHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
d= 1.2 √P
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
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d= 1.2 √P
d= 2.3 √P
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Caution: read instructions
(warnings) carefully
Follow instructions for use
Manufacturer Date of manufacture
Product code Lot number
IP22 Covering Protection rate
WEEE disposal
Authorized representative
in the European community
Medical Device complies
with Directive 93/42/EEC
Recyclable PVC Recyclable
This device compiles with Part 15
of FCC( Federal Communications
Commission) Rules
Restriction of Hazardous
Substances
Temperature limitation Moisture limitation
Atmospheric pressure limitation Serial number
Disposal: The product must not be disposed of along with other domestic
waste. The users must dispose of this equipment by bringing it to a specic
recycling point for electric and electronic equipment.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
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