Yuwell YHW-6 Infrared Thermometer

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User Manual

This is the main product document for model YHW-6.

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11 13 14 15 16 17 1812
10. Temperature Sense
YY-THM0015D-01(A/0)
13. Warranty Card
Warranty card
Product name:
Infrared thermometer
Model:
YHW-5/YHW-6
Table 3-Test specifications for ENCLOSURE PORT
IMMUNITY to RF wireless communications equipment
15. Guidance and Manufacturers Declaration
on EMC
1700-1990
2400-2570
GSM 1800;
CMDA 1900;
GSM 1900;
DECT;
LTE Band 1,3,
4,25; UMTS
Bluetooth,
WLAN,
802.11 b/g/n
RFID 2450,
LTE Band 7
1720
1845
1970
2450
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
217 Hz
Test
frequency
(MHz)
Band
a)
(MHz)
Service
a)
Modulation
b)
704-787
450
385
800-960
380-390
430-470
TETRA 400
GMRS 460,
FRS 460
LTE Band
13,17
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
710
745
780
810
870
930
Pulse
modulation
b)
18 Hz
FM
c)
±5 kHz
deviation
1 kHz sine
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
18 Hz
Test
frequency
(MHz)
IMMUNITY
TEST LEVEL
(V/m)
450
385
5240
5500
5785
710
745
780
810
870
930
1720
1845
1970
2450
5240
5500
5785
Pulse
modulation
b)
217 Hz
Maximum
power
(W)
5100-5800
1,8
2
Distance
(m)
WLAN 802.11
a/n
0,3
0,3
27
28
0,2
2
2
0,2
2
0,3
0,3
0,3
0,3
0,3
9
28
28
9
28
NOTE If necessary to achieve the IMMUNITY
TEST LEVEL, the distance between the transmit-
ting antenna and the ME EQUIPMENT or ME
SYSTEM may be reduced to 1 m. The 1 m test
distance is permitted by IEC 61000-4-3.
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.
Compliance
level
±8 kV contact
±15 kV air
30A/m
50Hz or 60Hz
10 V/m
80 MHz to 2.7 GHz
80% AM at 1kHz
Table 2-Compliance information for Immunity test
Table 1-Compliance information for Emission test
Phenomenon
ELECTROSTATIC
DISCHARGE
IEC 61000-4-2
RATED power
frequency
magnetic fields
IEC 61000-4-8
Radiated RF EM fields
IEC 61000-4-3
Emission test
Compliance
Group 1
RF emissions
CISPR 11
RF emissions
CISPR 11
Class B
Electromagnetic Compatibility (EMC) compliance
1.This device has been tested and complies with the
Class B limits for medical devices according to the
IEC 60601-1-2.
2.The thermometer is suitable for both professional
and home use, except near active HF SURGICAL
EQUIPMENT or in RF shielded magnetic resonance
imaging (MRI) rooms.
3.The thermometer measure ranges between 34.0
42.2℃ (93.2℉‒108.0). Accuracy is ±0.2℃
(±0.4) within 35.0℃ 42.0℃ (95.0℉‒107.6),
±0.3℃ (±0.5) beyond this range. When using the
device near strong electromagnetic interference
(e.g., cell phones, microwaves, etc.), it may
temporarily affect accuracy. Please keep the device
away if necessary.
4.WARNING: Do not place the thermometer near or
stack it with other medical devices to avoid potential-
ly inaccurate measurements.
5.WARNING: Portable RF communications
equipment (including peripherals such as antenna
cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the
thermometer. Otherwise, degradation of the
performance of the thermometer could result.
Table 1. Electromagnetic emissions
12. After-sales Service
11. Replacing The Batteries
1.The state of the internal electrical power source
will display a different icon depending on the battery
capacity. When the screen only displays the symbol
" " , prompt to replace the battery as soon as
possible; when the symbol " " is displayed,
replace the battery immediately. Replace with 2 new
AAA batteries, slide open the battery cover and
remove old batteries. Replace the batteries being
sure to align properly as indicated inside the battery
compartment.
2.Remove the battery from the product if it is not
required for extended periods of time in order to
avoid damage to the thermometer resulting from a
leaking battery.
3.To protect the environment, dispose of empty
batteries at appropriate collection sites according to
national or local regulations.
1.The thermometer is calibrated initially when
manufactured. There is no need for readjustment if it
is used according to the instruction. If at anytime you
question the accuracy of the temperature measure-
ment, please contact the manufacturer.
Adjusted mode is for general public and calibration
mode is for after-sale person only.
2.This product provides free maintenance service
for one year. If you need to provide circuit diagram,
necessary materials and maintenance of electrical
circuit for any problem, please contact the
manufacturer.
3. No free warranty service will be provided for the
faults caused by the following use:
1) Failure caused by unauthorized disassembly and
modification of products.
2) Failure caused by product drop.
3) Failure caused by failure to operate according to
the instructions.
4) Failure caused by lack of reasonable mainte-
nance.
5) Damage caused by external force.
4. This product will not cause allergic reaction and
harm to human body during normal use.
5.If the situations cannot be solved or unexpected
problem happens, please consult the local distributor.
6.Any serious incident that has occurred in relation
to the device please report to the manufacturer and
the competent authority of the Member State.
14. Connect To HealthCare+
For details, please refer to the APP Quick Guide.
1.To ensure that the measurement results can be
transmitted through Bluetooth, please keep the
distance between the device and the mobile phone
no more than 10 meters.
2.If you want your body temperature measurements
to be sent to your phone via Bluetooth, get a phone
that supports Android 5.0 and above or IOS 10.0 and
above to download Yuwell HealthCare+.
REFERENCE BODY SITE Oral measurement
CLINICAL
BIAS(
Δcb)
LIMITS OF
AGREEMENT
(LA
CLINICAL
REPEATABI
-LITY(
σr
)
Measuring site of
infrared thermometer
Forehead
Less than
1 year of age
-0.09℃
0.62℃
0.13℃
Aged
1-5 years
-0.17℃
0.95℃
0.21℃
Older than
5 years
-0.10℃
0.95℃
0.22℃
Revision date: Mar. 2026
YHW-5/YHW-6
Infrared Thermometer
User Manual And Technical Instruction
Service life: 5 years. Please read the user manual carefully and
follow the instructions before use. For date of manufacture, please
refer to the packaging.
The picture is for reference only, please refer to the actual product.
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO.,LTD.
No.1 Baisheng Road Development Zone, Danyang,
Jiangsu 212300 CHINA
www.yuwell.com
The normal body temperature of people is a range,
different people's normal body temperature varies,
and individual body temperature will change at
different times.
The normal body temperature of most people is
provided as follows, just for reference.
Axillary temperature:
36.0℃~37.4℃/96.8~99.32
Oral temperature:
36.3℃~37.2℃/97.34~98.96
Rectal temperature:
36.9℃~37.9℃/98.42~100.22
16. Cybersecurity
1.Cybersecurity Controls and Product Specification
Description
(1) The device and the App communicate via
Bluetooth, ensuring secure communication through
a private protocol.
(2) Please ensure that your network environment
has installed and updated firewall and antivirus
software to protect against malicious software and
virus intrusions.
2. Detailed Cybersecurity Implementation Diagram
3. Network Interface and Port Description
4. Support Infrastructure Requirements
(1) Users should only pair the device with their
mobile phones in a secure and trusted environment;
for example:
●Encrypted broadband networks
●Dedicated network lines
●WIFIPersonal portable Wi-Fi
(2) Place the device as far away as possible from
other electronic devices that may cause interfer-
ence. For instance, maintain a certain distance from
other Bluetooth devices, Wi-Fi routers, and
microwave ovens.
(3) It is recommended that users protect their mobile
phones to prevent unauthorized access to personal
data by:
●Setting an automatic keyboard lock on the phone
to prevent unauthorized use;
●Configuring a personal device PIN or password to
unlock the keyboard;
●Installing security protection software on the
phone to guard against viruses, trojans, and other
Infrared
thermom-
eter
Yuwell
HeaithCare+
app
Trust boundary
Date transfer by
Bluetooth
Interface
Interface
functionality
Attribute
Approved
Destination
End-points
Bluetooth
Transmit measured
body temperature values
Outgoing
Yuwell
HealthCare+ application
intrusions.
(4) Please do not install or use the APP on rooted or
jailbroken devices.
5.Software Bill of Materials (SBOM): An international
standard Software Bill of Materials (SBOM) in SPDX
format has been generated, supporting conversion to
other international and industry-standard SBOM
formats such as CycloneDX and SWID. If required,
users can send an email to request the latest SBOM
list.
6. Software and Firmware Download
(1) The App is distributed exclusively through the
Google Play Store and Apple Store. Downloading
software updates from unauthorized channels
increases the risk of cybersecurity vulnerabilities.
Our company bears no responsibility for any
consequences that may arise from such actions.
(2) Users should regularly check and perform
available updates for the APP software to promptly
address potential security vulnerabilities.
7. Security Event Response Design
The device operates fully localized, without commu-
nication to the cloud, and does not handle sensitive
personal data. Data transmission is based on
Bluetooth protocol.
8. Critical Function Protection
The device operates fully localized without network-
ing. Its core functions remain unaffected even if the
device is partially damaged and unusable.
9. Backup and Restore Features
No such function
10. Retention and Recovery of Device Configura-
tion
The device operates fully offline and uses
Bluetooth for communication. There is no risk of
network-based attacks (e.g., DDoS attacks, etc.),
and neither the device nor the app requires security
configurations.
11. Secure configuration of device
The device and app do not have security configura-
tions. Bluetooth communication is used, and the
manufacturer has closed all service ports to prevent
attacks, as confirmed by security testing.
12. Capture of Forensic Evidence
The app does not generate log files because internet
connectivity is absent to transmit log files.
13. Information Concerning Device Cybersecurity
End of Support and End of Life
During the valid service period of the device, our
company will provide continuous tracking and repair
of any security issues that exist with the device. If the
device exceeds its service life, our company cannot
guarantee reasonable software update services for
users. Continued use of the device after support has
ended may pose certain security risks to users, and
it is recommended that users discontinue use of the
device.
14.Information on Securely Decommissioning
Devices
The device does not contain sensitive, confidential,
or proprietary data or software; users can delete all
measurement data on the device and in the app.
Supplier's Declaration of Conformity
47 CFR § 2.1077 Compliance Information
Trade Name:
Product name: Infrared thermometer
Model Number: YHW-6
Responsible party: YUWELL MEDTECH USA LLC
Address: 2152 Serene Ct, Keller, TX 76248
Contact information
Name: Fang Zhang
Telephone number: (206) 639-1311
E-mail address: [email protected]
FCC Compliance Statement
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.
background
WARNING: The measurement result is only for
reference, which is not a substitute for a physician's
diagnosis. It is very dangerous to self-judge and treat
only based on the measurement result. Please follow
the doctor's instructions.
WARNING: Please put the battery out of the reach of
children, otherwise it is dangerous.
WARNING: When the product is not used for a long time
(more than 3 months), remove the battery from device
to prevent the battery leakage.
WARNING: If there is a temperature difference between
the environment of the storage and that of the
measurement, place the device in the measuring
environment for more than 30 minutes, otherwise
there may be errors in the measurement results.
WARNING: It is forbidden to immerse the infrared
thermometer in any liquid, and it is forbidden to use it
for a long time under too high or low temperature
condition. No collisions, drops and mixing with sharp
objects.
WARNING: Do not put the battery close to the fire or into
the fire to avoid the battery explosion. Do not use the
battery when it leaks or molds. When discarding
batteries or this product, follow local regulations to
avoid contamination.
WARNING: This device contains sensitive electronic
components and should not be used in environments
with strong electromagnetic interference (e.g., mobile
phones, microwave ovens, etc.) to prevent temporary
impacts on its accuracy.
WARNING: Do not modify the device without authoriza-
tion from the manufacturer. If the device is damaged,
return the device to the manufacturer or distributor for
service.
WARNING: If the situations cannot be solved or
unexpected problem happens, please consult the local
01 03 0402
2. Device Structure and Composition
05 06 07
●Device main structure and composition
The thermometer consists of a housing, a sensor, a
display and a circuit board.
Detachable parts and materials for use: cover, 2
AAA alkaline batteries
Battery
Reminder
Temperature Unit
Sound Prompt
Body Temperature
Mode
Result Display
Object Temperature
Mode
Memory Mark
Phenomenon
of breakdown
The operating
environment
temperature is lower
than 10℃ (50.0)
When in body
temperature mode,
the measurement
result is >43.0℃
(109.4) or when in
the object
temperature mode,
the measurement
result is >60.0℃
(140.0)
The
screen
display
" "
The
screen
display
" "
Possible cause
Trouble shooting
methods
In the body
temperature mode,
the measurement
result is<22.0℃
(71.6) or in the
object temperature
mode, the
measurement result
is <0.0℃ (32.0)
The
screen
display
" "
The
screen
display
" "
The operating
environment
temperature is higher
than 40℃(104.0)
08 09
10
Power On/
Measure Button
LCD Display
Area
Temperature
Probe
Battery
Cover
Mode
Button
Memory
Button
MODE MEMO
distributor.
WARNING: Do not immerse this device in medical
alcohol or other liquids.
WARNING: Avoid contact between liquid and the
devices metal parts.
WARNING: Dispose of thermometer, accessories, and
battery per local laws and regulations.
WARNING: This device contains batteries and
recyclable electronic components. To protect the
environment, do not dispose of it with household
waste. Dispose of used batteries at an appropriate
collection location following national or local
regulations.
CAUTION: Do not try to measure when the device is
wet, which may cause measurement results
inaccurate.
CAUTION: Before measurement, please make sure
that there is no sweat, cosmetics or oil stains on the
forehead of subject. Please make sure that the subject
does not take a bath, exercise or have a meal within 30
minutes, and the body is measured at a steady state.
CAUTION: During measurement, do not let the subject
directly face sunlight, heater or the air outlet of air
conditioner, which will change the temperature of the
forehead. Please conduct measurement in a stable
environment as far as possible.
CAUTION: When the product gets wet due to contact
with steam, do not use until it get dry or be gently wiped
with a soft, dry cloth or cotton balls, otherwise it will
cause measurement errors.
CAUTION: For patients measuring their own tempera-
ture, it is recommended to measure close to the
forehead.
CAUTION: Please read this instruction carefully before
use and confirm that the battery is installed.
CAUTION: Do not move while using.
CAUTION: Under the combined effects of the environ-
ment and the frequency of use, the product's housing
temperature may exceed 41℃. Please use it carefully.
CAUTION: Please pay attention to product storage to
prevent damage caused by pets, pests or children.
CAUTION: This product is a high-precision device,
please do not drop the device! Avoid drastic collisions
and jolts and other adverse possibilities for transport.
CAUTION: Due to the limited size of the label, the font is
too small, please put it in the appropriate position to
watch.
CAUTION: Do not store this thermometer in tempera-
ture extremes below -20℃(-4) or over +55℃(131
) or in excessive humidity (below 15% or above 90%
non-condensing relative humidity).
CAUTION: Do not use this thermometer in temperature
extremes below 10℃(50) or over 40℃(104) or in
excessive humidity (below 15% or above 90%
non-condensing relative humidity).
●Measurement environment:
Temperature: 10℃ (50
) to 40℃ (104)
Relative humidity: 15% to 90% (no condensation)
Atmospheric pressure: 70kPa to 106kPa
●Transportation and storage environment:
Temperature: -20℃(-4
) to +55℃ (131)
Relative humidity: 15% to 90%(no condensation)
Atmospheric pressure: 70kPa to 106kPa
When body temperature is 37.6 ℃(99.7) or higher,
the device will make sounds as "di-di-di" to prompt.
●Object temperature mode (Measure temperature
of object)
Short press the mode button in the power-on state,
and the display icon flashes to switch between body
temperature mode and object temperature mode.
After selecting " "(object temperature mode),
approach the object to be measured and press the
Power On/ Measure Button " " to display the
measurement result.
When the measured result is beyond device
measurement range Object temperature mode:
0.0℃~60.0℃(32.0~140.0), the thermometer will
make sounds as "di-di-di" to prompt, at the same
time, " " or " " appears on the display interface.
Notes: Please make sure the measurement method
and the external environment is normal at this time.
●Memory function : press memory button, memory
value inquiry can be carried out. Thermometer can
store 32 groups of memory values. When the
number of groups exceeds the specified number, the
latest memory value will cover the earliest memory
value.
●In memory mode, press and hold memory button,
when CLr is displayed on the screen, the memory
value is cleared.
●Sound switch setting
Step 1: In the shutdown state, long press the mode
button until the temperature unit flashes.
Step 2: Then short press memory button to switch to
sound setting.
Step 3: Press mode button to select sound on " "
or sound off " ".
Step 4: Press the Power On/ Measure Button " " to
confirm.
●Power off
In the absence of any operation, the device will
automatically shut down within 2 minutes.
6. Cleaning and Disinfection
Manual cleaning procedure
1. Use a clean and dry soft cloth or cotton swab to
gently wipe the sensor lens for a minimum of 30
seconds.
2. Thoroughly wipe the device surfaces with a
non-linting cloth dampened (not dripping) with soap
solution for at least three (3) minutes. And wipe the
device surface with a non-linting cloth dampened
(not dripping) with bottled water for at least three (3)
minutes.
NOTE: Prepare the cleaning solution according to the
detergent manufacturers instructions. (e.g.,
Alconox
® Powdered Precision Cleaner, 10 g/L)
NOTE: Pay extra attention to the device's cracks,
crevices, and hard-to-reach areas.
3. Dry the device thoroughly with a soft, clean,
non-linting cloth.
Post-cleaning inspection
Inspect the device visually after cleaning for
cleanliness, damage, and missing or illegible device
labeling or markings:
1.If any visible dirt or residue remains, repeat the
cleaning procedure.
2.Any damaged device should be removed from use.
Damage may include, but is not limited to, corrosion,
discoloration, excessive scratches, flaking, cracks,
and wear.
3. Remove any device with missing, illegible device
labeling or marking from use.
Disinfection procedure
1. Clean the device before disinfection.
2. With the probe facing down, wipe the device
surfaces with a non-linting cloth dampened (not
dripping) with 70% Isopropyl Alcohol (IPA).
3. Allow all surfaces to remain wet for at least two (2)
minutes. If necessary, use additional wipes to
ensure the surfaces remain wet for the full duration.
4. Dry thoroughly with a soft, clean, non-linting cloth.
5. Allow at least five (5) minutes of drying before
taking a temperature reading. Make sure the probe
lens is clean and dry before use.
7. Troubleshooting Instructions
Replace with
new batteries
The
screen
display
" "
The power of
batteries is shortage
The
screen
display
" "
Please contact
the dealer and
send it to the
factory for repair
Infrared sensor
sampling error
Please
remeasure
following the
product
instruction
Place the infrared
thermometer at
an ambient
temperature of 10℃
to 40℃ (50 to
104) and let it
stand for 30
minutes before
measuring. If the
problem persists,
please contact
the dealer and
send it to the
factory for repair
No display
The batteries are
not installed well
Low battery
Check if the
batteries are
installed upside
down
Replace with
new batteries
Please contact
the dealer and
send it to the
factory for repair
The screen is
still blank
9. Technical Specification
●Power source: DC 3V (2×1.5V AAA alkaline batteries)
●Measurement range in body temperature mode:
22.0℃~43.0℃(71.6~109.4)
●Display resolution: 0.1℃(0.1)
●Measurement accuracy:±0.2℃(±0.4) in the
range of 35.0℃~42.0℃(95.0~107.6); ±0.3℃
(±0.5) in the range of 22.0℃~34.9℃(71.6
94.8) and 42.1℃~43.0℃(107.8~109.4)
The positive and
negative poles of the
batteries are
reversed or the
device is abnormal
Reinstall the
batteries, or
contact the
dealer
5. Setup and Use
●Installing the battery
The device is supplied with
2 AAA alkaline batteries. Push
the battery cover downward and
load the battery into the battery
compartment. At this time, the
device will start self-inspection.
Pay attention to the positive and
negative poles instruction in the
battery compartment and snap
the battery cover back onto the
device. Refer to the picture at right:
●Setting measure unit
In the shutdown state, long press the mode button
until the unit symbol flashes, then short press the
mode button to select the temperature units " " and
" ", and press the Power On/ Measure Button" "
to confirm.
●Body temperature mode (Measure temperature of
human body)
1. Point the infrared thermometer probe at the center
of the eyebrows and keep a distance of 0-3 cm from
the forehead (non-contact).
2. Press the Power On/ Measure Button" ". After
about 1 second, the infrared thermometer will have a
prompt of sound and display the measurement results.
When the measured result is beyond device
measurement range Body temperature mode:
22.0℃~43.0℃(71.6~109.4); the thermometer
will make one quick continuous sounds as "di-di-di"
to prompt, at the same time, " " or " " appears on
the display interface, accompanied by an orange
backlight.
●According to ISO 80601-2-56, Rated output
range: 34.0℃ to 42.0℃(93.2 to 107.6). Rated
extended output range: 22.0℃ to 33.9℃ (71.6 to
93.0) and 42.1℃ to 43.0℃ (107.6 to 109.4)
●Electric shock protection: the device is supplied by
internal power
●Operation mode: continuous operation
●Temperature units: ℃/
●Body temperature mode measuring site: forehead
●Time interval of each measurement ≤1s.
●Measurement time: ≤1s.
●Degrees of protection provided by enclosures
(IP code): IP22
●Safety classification: the device that cannot be
used in the presence of flammable anesthetic gases
mixed with air or oxygen or nitrous oxide
●Product size: 6" ×1.5"×1.7"
(152mm×38mm×43mm)
●Product weight: About 0.15 lbs. (70g) (not
including battery)
●Number of memory groups: 32 groups
●Service life: 5 years
●The thermometer uses an adjusted mode when
measuring the body temperature.
●Battery replacement cycle: use the new battery for
no less than 3000 measurements
●Wireless connection: Bluetooth
●Frequency range: 2.400 GHz~2.4835 GHz
●Modulation mode: GFSK
●Transmitting power: ≤20dBm
●FCC ID: 2A2JJ-YHW-6
Recommended Range: ~10 feet (~3 meters)
line-of-sight
Quality of Service (QoS): Delay <10 seconds
This thermometer meets ASTM Standard E
1965-98 requirements. Full responsibility for the
conformance of this device to the standard is
assumed by JIANGSU YUYUE MEDICAL &
SUPPLY CO.,LTD..
ASTM laboratory accuracy requirements for
infrared thermometer in the display range of 37℃
39℃ (98 102) is ±0.2℃(±0.4), while for
mercury-in-glass and electronic thermometers, the
requirement, according to ASTM Standards
E667-86 and E1112-86 is ±0.1℃ (±0.2).
●The clinical validation was conducted according to
the requirements of ISO 80601-2-56. Take the
result measured by mercury thermometer from oral
cavity as the reference. Test three groups: 0 to 1
year old, older than 1 year and younger than 5
years, older than 5 years. The minimum number of
subjects in an age group shall be at least 35. The
test results are shown in the table below:
●Appendix:
Instructions, 2 AAA alkaline batteries
APP Quick Guide(for YHW-6).
●The thermometer uses an infrared sensor, which
can sense the ambient temperature and the infrared
heat radiation emitted by the human body.Referring
to the corresponding parameter table, the best core
algorithm is used to calculate the accurate tempera-
ture.
●Intended purpose: This device is used to measure
the forehead temperature of the human body. It is
intended for use on people of all ages except
pre-term babies or very small(small for gestational
age) babies.
●Indication: Intermittent measurement of human
body temperature from forehead, not for emergency
clinical condition.
●Intended users: Intended users: Health care
professional, or lay persons at least 11 years old.
●Clinical benefits: The device can be used to
measure body temperature so as to help to diagnose
body condition. The clinical benefit associated with
the device is defined as indirect, all intended patient
population can experience the benefit.
●Contraindication: None.
●The device is for professional use and consumer
use.
●Patient can take measurement by themselves, or
they can be taken by someone else using a
thermometer. Patients can perform all the mainte-
nance.
1. Device Use And Applicant Scope
3. Warnings and Precautions
4. Measurement And Transport Storage
Environment
CAUTION: To avoid dust entering the probe cavity
resulting in inaccurate measurements, install the
cover after each use.
CAUTION: Do not use non-specified detachable parts
and materials, otherwise the product may not work
properly.
CAUTION: This thermometer is not intended to
interpret hypothermic temperatures. If the device
displays a temperature of 36.4℃ (97.5 ) or less, and
the individual is exhibiting atypical symptoms or
behaviors, contact your physician or health care
professional.
CAUTION: Do not mix old and new batteries.
CAUTION: When using the thermometer with a smart
device, keep both devices within the recommended
range of each other (see Specifications for details);
moving outside of this range may cause a loss in
connection with the smart device.
CAUTION: When using the thermometer with a smart
device, keep the devices away from sources that may
interfere with the Bluetooth connection. Other devices
may cause radio frequency interference (RFI), which
may result in a loss of quality of service (see
Specifications for details) for the Bluetooth connection.
Devices that may cause RFI include but are not limited
to: electrocautery equipment, diathermy equipment,
other cellular telephones, wireless PC and tablets,
pagers, RFID devices, MRI, and electromagnetic
security systems.
CAUTION: The user is cautioned that changes or
modifications not expressly approved by the party
responsible for compliance could void the user's
authority to operate the equipment
NOTE: 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.
NOTE: This equipment has been tested and found to
comply with the limits for a Class B digital device,
according to Part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against
harmful interference in a residential installation. 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 encouraged to try to correct the
interference by one or more of the following measures:
●Reorient or relocate the receiving antenna.
The
screen
display
" "
The operating
environment
temperature has
changed
significantly
compared to the
storage
temperature.
Place the
thermometer at
the operating
environment
temperature for
30 minutes
before use.
Manufacturer mark
Symbols
Caution
Recyclable
Manufacturer
Implication
This way up
Fragile, handle with care
Keep dry
Date of manufacture
Serial number
Batch code
Medical device
Protection from ingress of particulates than
12.5mm. Dripping water falling within 15° of
vertical will not have a harmful effect on the
thermometer per IEC 60529
Temperature limit
Humidity limitation
Unique device identifier
Refer to instruction manual
Atmospheric pressure limitation
Catalogue number
UDI
Non-ionizing radiation
Safety and environmental protection use period
for 10 years
Symbol for the marking of electrical and electronic
devices according to Directive 2012/19/EU
10
Bluetooth
MR Unsafe. Not appropriate for use in MR
environment (i.e.: inside the MR magnet room)
●Increase the separation between the equipment and
receiver.
●Consult the dealer or an experienced radio/TV
technician for help.
8. Symbols
background
WARNING: The measurement result is only for
reference, which is not a substitute for a physician's
diagnosis. It is very dangerous to self-judge and treat
only based on the measurement result. Please follow
the doctor's instructions.
WARNING: Please put the battery out of the reach of
children, otherwise it is dangerous.
WARNING: When the product is not used for a long time
(more than 3 months), remove the battery from device
to prevent the battery leakage.
WARNING: If there is a temperature difference between
the environment of the storage and that of the
measurement, place the device in the measuring
environment for more than 30 minutes, otherwise
there may be errors in the measurement results.
WARNING: It is forbidden to immerse the infrared
thermometer in any liquid, and it is forbidden to use it
for a long time under too high or low temperature
condition. No collisions, drops and mixing with sharp
objects.
WARNING: Do not put the battery close to the fire or into
the fire to avoid the battery explosion. Do not use the
battery when it leaks or molds. When discarding
batteries or this product, follow local regulations to
avoid contamination.
WARNING: This device contains sensitive electronic
components and should not be used in environments
with strong electromagnetic interference (e.g., mobile
phones, microwave ovens, etc.) to prevent temporary
impacts on its accuracy.
WARNING: Do not modify the device without authoriza-
tion from the manufacturer. If the device is damaged,
return the device to the manufacturer or distributor for
service.
WARNING: If the situations cannot be solved or
unexpected problem happens, please consult the local
01 03 0402
2. Device Structure and Composition
05 06 07
●Device main structure and composition
The thermometer consists of a housing, a sensor, a
display and a circuit board.
Detachable parts and materials for use: cover, 2
AAA alkaline batteries
Battery
Reminder
Temperature Unit
Sound Prompt
Body Temperature
Mode
Result Display
Object Temperature
Mode
Memory Mark
Phenomenon
of breakdown
The operating
environment
temperature is lower
than 10℃ (50.0)
When in body
temperature mode,
the measurement
result is >43.0℃
(109.4) or when in
the object
temperature mode,
the measurement
result is >60.0℃
(140.0)
The
screen
display
" "
The
screen
display
" "
Possible cause
Trouble shooting
methods
In the body
temperature mode,
the measurement
result is<22.0℃
(71.6) or in the
object temperature
mode, the
measurement result
is <0.0℃ (32.0)
The
screen
display
" "
The
screen
display
" "
The operating
environment
temperature is higher
than 40℃(104.0)
08 09
10
Power On/
Measure Button
LCD Display
Area
Temperature
Probe
Battery
Cover
Mode
Button
Memory
Button
MODE MEMO
distributor.
WARNING: Do not immerse this device in medical
alcohol or other liquids.
WARNING: Avoid contact between liquid and the
devices metal parts.
WARNING: Dispose of thermometer, accessories, and
battery per local laws and regulations.
WARNING: This device contains batteries and
recyclable electronic components. To protect the
environment, do not dispose of it with household
waste. Dispose of used batteries at an appropriate
collection location following national or local
regulations.
CAUTION: Do not try to measure when the device is
wet, which may cause measurement results
inaccurate.
CAUTION: Before measurement, please make sure
that there is no sweat, cosmetics or oil stains on the
forehead of subject. Please make sure that the subject
does not take a bath, exercise or have a meal within 30
minutes, and the body is measured at a steady state.
CAUTION: During measurement, do not let the subject
directly face sunlight, heater or the air outlet of air
conditioner, which will change the temperature of the
forehead. Please conduct measurement in a stable
environment as far as possible.
CAUTION: When the product gets wet due to contact
with steam, do not use until it get dry or be gently wiped
with a soft, dry cloth or cotton balls, otherwise it will
cause measurement errors.
CAUTION: For patients measuring their own tempera-
ture, it is recommended to measure close to the
forehead.
CAUTION: Please read this instruction carefully before
use and confirm that the battery is installed.
CAUTION: Do not move while using.
CAUTION: Under the combined effects of the environ-
ment and the frequency of use, the product's housing
temperature may exceed 41℃. Please use it carefully.
CAUTION: Please pay attention to product storage to
prevent damage caused by pets, pests or children.
CAUTION: This product is a high-precision device,
please do not drop the device! Avoid drastic collisions
and jolts and other adverse possibilities for transport.
CAUTION: Due to the limited size of the label, the font is
too small, please put it in the appropriate position to
watch.
CAUTION: Do not store this thermometer in tempera-
ture extremes below -20℃(-4) or over +55℃(131
) or in excessive humidity (below 15% or above 90%
non-condensing relative humidity).
CAUTION: Do not use this thermometer in temperature
extremes below 10℃(50) or over 40℃(104) or in
excessive humidity (below 15% or above 90%
non-condensing relative humidity).
●Measurement environment:
Temperature: 10℃ (50
) to 40℃ (104)
Relative humidity: 15% to 90% (no condensation)
Atmospheric pressure: 70kPa to 106kPa
●Transportation and storage environment:
Temperature: -20℃(-4
) to +55℃ (131)
Relative humidity: 15% to 90%(no condensation)
Atmospheric pressure: 70kPa to 106kPa
When body temperature is 37.6 ℃(99.7) or higher,
the device will make sounds as "di-di-di" to prompt.
●Object temperature mode (Measure temperature
of object)
Short press the mode button in the power-on state,
and the display icon flashes to switch between body
temperature mode and object temperature mode.
After selecting " "(object temperature mode),
approach the object to be measured and press the
Power On/ Measure Button " " to display the
measurement result.
When the measured result is beyond device
measurement range Object temperature mode:
0.0℃~60.0℃(32.0~140.0), the thermometer will
make sounds as "di-di-di" to prompt, at the same
time, " " or " " appears on the display interface.
Notes: Please make sure the measurement method
and the external environment is normal at this time.
●Memory function : press memory button, memory
value inquiry can be carried out. Thermometer can
store 32 groups of memory values. When the
number of groups exceeds the specified number, the
latest memory value will cover the earliest memory
value.
●In memory mode, press and hold memory button,
when CLr is displayed on the screen, the memory
value is cleared.
●Sound switch setting
Step 1: In the shutdown state, long press the mode
button until the temperature unit flashes.
Step 2: Then short press memory button to switch to
sound setting.
Step 3: Press mode button to select sound on " "
or sound off " ".
Step 4: Press the Power On/ Measure Button " " to
confirm.
●Power off
In the absence of any operation, the device will
automatically shut down within 2 minutes.
6. Cleaning and Disinfection
Manual cleaning procedure
1. Use a clean and dry soft cloth or cotton swab to
gently wipe the sensor lens for a minimum of 30
seconds.
2. Thoroughly wipe the device surfaces with a
non-linting cloth dampened (not dripping) with soap
solution for at least three (3) minutes. And wipe the
device surface with a non-linting cloth dampened
(not dripping) with bottled water for at least three (3)
minutes.
NOTE: Prepare the cleaning solution according to the
detergent manufacturers instructions. (e.g.,
Alconox
® Powdered Precision Cleaner, 10 g/L)
NOTE: Pay extra attention to the device's cracks,
crevices, and hard-to-reach areas.
3. Dry the device thoroughly with a soft, clean,
non-linting cloth.
Post-cleaning inspection
Inspect the device visually after cleaning for
cleanliness, damage, and missing or illegible device
labeling or markings:
1.If any visible dirt or residue remains, repeat the
cleaning procedure.
2.Any damaged device should be removed from use.
Damage may include, but is not limited to, corrosion,
discoloration, excessive scratches, flaking, cracks,
and wear.
3. Remove any device with missing, illegible device
labeling or marking from use.
Disinfection procedure
1. Clean the device before disinfection.
2. With the probe facing down, wipe the device
surfaces with a non-linting cloth dampened (not
dripping) with 70% Isopropyl Alcohol (IPA).
3. Allow all surfaces to remain wet for at least two (2)
minutes. If necessary, use additional wipes to
ensure the surfaces remain wet for the full duration.
4. Dry thoroughly with a soft, clean, non-linting cloth.
5. Allow at least five (5) minutes of drying before
taking a temperature reading. Make sure the probe
lens is clean and dry before use.
7. Troubleshooting Instructions
Replace with
new batteries
The
screen
display
" "
The power of
batteries is shortage
The
screen
display
" "
Please contact
the dealer and
send it to the
factory for repair
Infrared sensor
sampling error
Please
remeasure
following the
product
instruction
Place the infrared
thermometer at
an ambient
temperature of 10℃
to 40℃ (50 to
104) and let it
stand for 30
minutes before
measuring. If the
problem persists,
please contact
the dealer and
send it to the
factory for repair
No display
The batteries are
not installed well
Low battery
Check if the
batteries are
installed upside
down
Replace with
new batteries
Please contact
the dealer and
send it to the
factory for repair
The screen is
still blank
9. Technical Specification
●Power source: DC 3V (2×1.5V AAA alkaline batteries)
●Measurement range in body temperature mode:
22.0℃~43.0℃(71.6~109.4)
●Display resolution: 0.1℃(0.1)
●Measurement accuracy:±0.2℃(±0.4) in the
range of 35.0℃~42.0℃(95.0~107.6); ±0.3℃
(±0.5) in the range of 22.0℃~34.9℃(71.6
94.8) and 42.1℃~43.0℃(107.8~109.4)
The positive and
negative poles of the
batteries are
reversed or the
device is abnormal
Reinstall the
batteries, or
contact the
dealer
5. Setup and Use
●Installing the battery
The device is supplied with
2 AAA alkaline batteries. Push
the battery cover downward and
load the battery into the battery
compartment. At this time, the
device will start self-inspection.
Pay attention to the positive and
negative poles instruction in the
battery compartment and snap
the battery cover back onto the
device. Refer to the picture at right:
●Setting measure unit
In the shutdown state, long press the mode button
until the unit symbol flashes, then short press the
mode button to select the temperature units " " and
" ", and press the Power On/ Measure Button" "
to confirm.
●Body temperature mode (Measure temperature of
human body)
1. Point the infrared thermometer probe at the center
of the eyebrows and keep a distance of 0-3 cm from
the forehead (non-contact).
2. Press the Power On/ Measure Button" ". After
about 1 second, the infrared thermometer will have a
prompt of sound and display the measurement results.
When the measured result is beyond device
measurement range Body temperature mode:
22.0℃~43.0℃(71.6~109.4); the thermometer
will make one quick continuous sounds as "di-di-di"
to prompt, at the same time, " " or " " appears on
the display interface, accompanied by an orange
backlight.
●According to ISO 80601-2-56, Rated output
range: 34.0℃ to 42.0℃(93.2 to 107.6). Rated
extended output range: 22.0℃ to 33.9℃ (71.6 to
93.0) and 42.1℃ to 43.0℃ (107.6 to 109.4)
●Electric shock protection: the device is supplied by
internal power
●Operation mode: continuous operation
●Temperature units: ℃/
●Body temperature mode measuring site: forehead
●Time interval of each measurement ≤1s.
●Measurement time: ≤1s.
●Degrees of protection provided by enclosures
(IP code): IP22
●Safety classification: the device that cannot be
used in the presence of flammable anesthetic gases
mixed with air or oxygen or nitrous oxide
●Product size: 6" ×1.5"×1.7"
(152mm×38mm×43mm)
●Product weight: About 0.15 lbs. (70g) (not
including battery)
●Number of memory groups: 32 groups
●Service life: 5 years
●The thermometer uses an adjusted mode when
measuring the body temperature.
●Battery replacement cycle: use the new battery for
no less than 3000 measurements
●Wireless connection: Bluetooth
●Frequency range: 2.400 GHz~2.4835 GHz
●Modulation mode: GFSK
●Transmitting power: ≤20dBm
●FCC ID: 2A2JJ-YHW-6
Recommended Range: ~10 feet (~3 meters)
line-of-sight
Quality of Service (QoS): Delay <10 seconds
This thermometer meets ASTM Standard E
1965-98 requirements. Full responsibility for the
conformance of this device to the standard is
assumed by JIANGSU YUYUE MEDICAL &
SUPPLY CO.,LTD..
ASTM laboratory accuracy requirements for
infrared thermometer in the display range of 37℃
39℃ (98 102) is ±0.2℃(±0.4), while for
mercury-in-glass and electronic thermometers, the
requirement, according to ASTM Standards
E667-86 and E1112-86 is ±0.1℃ (±0.2).
●The clinical validation was conducted according to
the requirements of ISO 80601-2-56. Take the
result measured by mercury thermometer from oral
cavity as the reference. Test three groups: 0 to 1
year old, older than 1 year and younger than 5
years, older than 5 years. The minimum number of
subjects in an age group shall be at least 35. The
test results are shown in the table below:
●Appendix:
Instructions, 2 AAA alkaline batteries,
APP Quick Guide(for YHW-6).
●The thermometer uses an infrared sensor, which
can sense the ambient temperature and the infrared
heat radiation emitted by the human body.Referring
to the corresponding parameter table, the best core
algorithm is used to calculate the accurate tempera-
ture.
●Intended purpose: This device is used to measure
the forehead temperature of the human body. It is
intended for use on people of all ages except
pre-term babies or very small(small for gestational
age) babies.
●Indication: Intermittent measurement of human
body temperature from forehead, not for emergency
clinical condition.
●Intended users: Intended users: Health care
professional, or lay persons at least 11 years old.
●Clinical benefits: The device can be used to
measure body temperature so as to help to diagnose
body condition. The clinical benefit associated with
the device is defined as indirect, all intended patient
population can experience the benefit.
●Contraindication: None.
●The device is for professional use and consumer
use.
●Patient can take measurement by themselves, or
they can be taken by someone else using a
thermometer. Patients can perform all the mainte-
nance.
1. Device Use And Applicant Scope
3. Warnings and Precautions
4. Measurement And Transport Storage
Environment
CAUTION: To avoid dust entering the probe cavity
resulting in inaccurate measurements, install the
cover after each use.
CAUTION: Do not use non-specified detachable parts
and materials, otherwise the product may not work
properly.
CAUTION: This thermometer is not intended to
interpret hypothermic temperatures. If the device
displays a temperature of 36.4℃ (97.5 ) or less, and
the individual is exhibiting atypical symptoms or
behaviors, contact your physician or health care
professional.
CAUTION: Do not mix old and new batteries.
CAUTION: When using the thermometer with a smart
device, keep both devices within the recommended
range of each other (see Specifications for details);
moving outside of this range may cause a loss in
connection with the smart device.
CAUTION: When using the thermometer with a smart
device, keep the devices away from sources that may
interfere with the Bluetooth connection. Other devices
may cause radio frequency interference (RFI), which
may result in a loss of quality of service (see
Specifications for details) for the Bluetooth connection.
Devices that may cause RFI include but are not limited
to: electrocautery equipment, diathermy equipment,
other cellular telephones, wireless PC and tablets,
pagers, RFID devices, MRI, and electromagnetic
security systems.
CAUTION: The user is cautioned that changes or
modifications not expressly approved by the party
responsible for compliance could void the user's
authority to operate the equipment
NOTE: 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.
NOTE: This equipment has been tested and found to
comply with the limits for a Class B digital device,
according to Part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against
harmful interference in a residential installation. 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 encouraged to try to correct the
interference by one or more of the following measures:
●Reorient or relocate the receiving antenna.
The
screen
display
" "
The operating
environment
temperature has
changed
significantly
compared to the
storage
temperature.
Place the
thermometer at
the operating
environment
temperature for
30 minutes
before use.
Manufacturer mark
Symbols
Caution
Recyclable
Manufacturer
Implication
This way up
Fragile, handle with care
Keep dry
Date of manufacture
Serial number
Batch code
Medical device
Protection from ingress of particulates than
12.5mm. Dripping water falling within 15° of
vertical will not have a harmful effect on the
thermometer per IEC 60529
Temperature limit
Humidity limitation
Unique device identifier
Refer to instruction manual
Atmospheric pressure limitation
Catalogue number
UDI
Non-ionizing radiation
Safety and environmental protection use period
for 10 years
Symbol for the marking of electrical and electronic
devices according to Directive 2012/19/EU
10
Bluetooth
MR Unsafe. Not appropriate for use in MR
environment (i.e.: inside the MR magnet room)
●Increase the separation between the equipment and
receiver.
●Consult the dealer or an experienced radio/TV
technician for help.
8. Symbols
background
WARNING: The measurement result is only for
reference, which is not a substitute for a physician's
diagnosis. It is very dangerous to self-judge and treat
only based on the measurement result. Please follow
the doctor's instructions.
WARNING: Please put the battery out of the reach of
children, otherwise it is dangerous.
WARNING: When the product is not used for a long time
(more than 3 months), remove the battery from device
to prevent the battery leakage.
WARNING: If there is a temperature difference between
the environment of the storage and that of the
measurement, place the device in the measuring
environment for more than 30 minutes, otherwise
there may be errors in the measurement results.
WARNING: It is forbidden to immerse the infrared
thermometer in any liquid, and it is forbidden to use it
for a long time under too high or low temperature
condition. No collisions, drops and mixing with sharp
objects.
WARNING: Do not put the battery close to the fire or into
the fire to avoid the battery explosion. Do not use the
battery when it leaks or molds. When discarding
batteries or this product, follow local regulations to
avoid contamination.
WARNING: This device contains sensitive electronic
components and should not be used in environments
with strong electromagnetic interference (e.g., mobile
phones, microwave ovens, etc.) to prevent temporary
impacts on its accuracy.
WARNING: Do not modify the device without authoriza-
tion from the manufacturer. If the device is damaged,
return the device to the manufacturer or distributor for
service.
WARNING: If the situations cannot be solved or
unexpected problem happens, please consult the local
01 03 0402
2. Device Structure and Composition
05 06 07
●Device main structure and composition
The thermometer consists of a housing, a sensor, a
display and a circuit board.
Detachable parts and materials for use: cover, 2
AAA alkaline batteries
Battery
Reminder
Temperature Unit
Sound Prompt
Body Temperature
Mode
Result Display
Object Temperature
Mode
Memory Mark
Phenomenon
of breakdown
The operating
environment
temperature is lower
than 10℃ (50.0)
When in body
temperature mode,
the measurement
result is >43.0℃
(109.4) or when in
the object
temperature mode,
the measurement
result is >60.0℃
(140.0)
The
screen
display
" "
The
screen
display
" "
Possible cause
Trouble shooting
methods
In the body
temperature mode,
the measurement
result is<22.0℃
(71.6) or in the
object temperature
mode, the
measurement result
is <0.0℃ (32.0)
The
screen
display
" "
The
screen
display
" "
The operating
environment
temperature is higher
than 40℃(104.0)
08 09
10
Power On/
Measure Button
LCD Display
Area
Temperature
Probe
Battery
Cover
Mode
Button
Memory
Button
MODE MEMO
distributor.
WARNING: Do not immerse this device in medical
alcohol or other liquids.
WARNING: Avoid contact between liquid and the
devices metal parts.
WARNING: Dispose of thermometer, accessories, and
battery per local laws and regulations.
WARNING: This device contains batteries and
recyclable electronic components. To protect the
environment, do not dispose of it with household
waste. Dispose of used batteries at an appropriate
collection location following national or local
regulations.
CAUTION: Do not try to measure when the device is
wet, which may cause measurement results
inaccurate.
CAUTION: Before measurement, please make sure
that there is no sweat, cosmetics or oil stains on the
forehead of subject. Please make sure that the subject
does not take a bath, exercise or have a meal within 30
minutes, and the body is measured at a steady state.
CAUTION: During measurement, do not let the subject
directly face sunlight, heater or the air outlet of air
conditioner, which will change the temperature of the
forehead. Please conduct measurement in a stable
environment as far as possible.
CAUTION: When the product gets wet due to contact
with steam, do not use until it get dry or be gently wiped
with a soft, dry cloth or cotton balls, otherwise it will
cause measurement errors.
CAUTION: For patients measuring their own tempera-
ture, it is recommended to measure close to the
forehead.
CAUTION: Please read this instruction carefully before
use and confirm that the battery is installed.
CAUTION: Do not move while using.
CAUTION: Under the combined effects of the environ-
ment and the frequency of use, the product's housing
temperature may exceed 41℃. Please use it carefully.
CAUTION: Please pay attention to product storage to
prevent damage caused by pets, pests or children.
CAUTION: This product is a high-precision device,
please do not drop the device! Avoid drastic collisions
and jolts and other adverse possibilities for transport.
CAUTION: Due to the limited size of the label, the font is
too small, please put it in the appropriate position to
watch.
CAUTION: Do not store this thermometer in tempera-
ture extremes below -20℃(-4) or over +55℃(131
) or in excessive humidity (below 15% or above 90%
non-condensing relative humidity).
CAUTION: Do not use this thermometer in temperature
extremes below 10℃(50) or over 40℃(104) or in
excessive humidity (below 15% or above 90%
non-condensing relative humidity).
●Measurement environment:
Temperature: 10℃ (50
) to 40℃ (104)
Relative humidity: 15% to 90% (no condensation)
Atmospheric pressure: 70kPa to 106kPa
●Transportation and storage environment:
Temperature: -20℃(-4
) to +55℃ (131)
Relative humidity: 15% to 90%(no condensation)
Atmospheric pressure: 70kPa to 106kPa
When body temperature is 37.6 ℃(99.7) or higher,
the device will make sounds as "di-di-di" to prompt.
●Object temperature mode (Measure temperature
of object)
Short press the mode button in the power-on state,
and the display icon flashes to switch between body
temperature mode and object temperature mode.
After selecting " "(object temperature mode),
approach the object to be measured and press the
Power On/ Measure Button " " to display the
measurement result.
When the measured result is beyond device
measurement range Object temperature mode:
0.0℃~60.0℃(32.0~140.0), the thermometer will
make sounds as "di-di-di" to prompt, at the same
time, " " or " " appears on the display interface.
Notes: Please make sure the measurement method
and the external environment is normal at this time.
●Memory function : press memory button, memory
value inquiry can be carried out. Thermometer can
store 32 groups of memory values. When the
number of groups exceeds the specified number, the
latest memory value will cover the earliest memory
value.
●In memory mode, press and hold memory button,
when CLr is displayed on the screen, the memory
value is cleared.
●Sound switch setting
Step 1: In the shutdown state, long press the mode
button until the temperature unit flashes.
Step 2: Then short press memory button to switch to
sound setting.
Step 3: Press mode button to select sound on " "
or sound off " ".
Step 4: Press the Power On/ Measure Button " " to
confirm.
●Power off
In the absence of any operation, the device will
automatically shut down within 2 minutes.
6. Cleaning and Disinfection
Manual cleaning procedure
1. Use a clean and dry soft cloth or cotton swab to
gently wipe the sensor lens for a minimum of 30
seconds.
2. Thoroughly wipe the device surfaces with a
non-linting cloth dampened (not dripping) with soap
solution for at least three (3) minutes. And wipe the
device surface with a non-linting cloth dampened
(not dripping) with bottled water for at least three (3)
minutes.
NOTE: Prepare the cleaning solution according to the
detergent manufacturers instructions. (e.g.,
Alconox
® Powdered Precision Cleaner, 10 g/L)
NOTE: Pay extra attention to the device's cracks,
crevices, and hard-to-reach areas.
3. Dry the device thoroughly with a soft, clean,
non-linting cloth.
Post-cleaning inspection
Inspect the device visually after cleaning for
cleanliness, damage, and missing or illegible device
labeling or markings:
1.If any visible dirt or residue remains, repeat the
cleaning procedure.
2.Any damaged device should be removed from use.
Damage may include, but is not limited to, corrosion,
discoloration, excessive scratches, flaking, cracks,
and wear.
3. Remove any device with missing, illegible device
labeling or marking from use.
Disinfection procedure
1. Clean the device before disinfection.
2. With the probe facing down, wipe the device
surfaces with a non-linting cloth dampened (not
dripping) with 70% Isopropyl Alcohol (IPA).
3. Allow all surfaces to remain wet for at least two (2)
minutes. If necessary, use additional wipes to
ensure the surfaces remain wet for the full duration.
4. Dry thoroughly with a soft, clean, non-linting cloth.
5. Allow at least five (5) minutes of drying before
taking a temperature reading. Make sure the probe
lens is clean and dry before use.
7. Troubleshooting Instructions
Replace with
new batteries
The
screen
display
" "
The power of
batteries is shortage
The
screen
display
" "
Please contact
the dealer and
send it to the
factory for repair
Infrared sensor
sampling error
Please
remeasure
following the
product
instruction
Place the infrared
thermometer at
an ambient
temperature of 10℃
to 40℃ (50 to
104) and let it
stand for 30
minutes before
measuring. If the
problem persists,
please contact
the dealer and
send it to the
factory for repair
No display
The batteries are
not installed well
Low battery
Check if the
batteries are
installed upside
down
Replace with
new batteries
Please contact
the dealer and
send it to the
factory for repair
The screen is
still blank
9. Technical Specification
●Power source: DC 3V (2×1.5V AAA alkaline batteries)
●Measurement range in body temperature mode:
22.0℃~43.0℃(71.6~109.4)
●Display resolution: 0.1℃(0.1)
●Measurement accuracy:±0.2℃(±0.4) in the
range of 35.0℃~42.0℃(95.0~107.6); ±0.3℃
(±0.5) in the range of 22.0℃~34.9℃(71.6
94.8) and 42.1℃~43.0℃(107.8~109.4)
The positive and
negative poles of the
batteries are
reversed or the
device is abnormal
Reinstall the
batteries, or
contact the
dealer
5. Setup and Use
●Installing the battery
The device is supplied with
2 AAA alkaline batteries. Push
the battery cover downward and
load the battery into the battery
compartment. At this time, the
device will start self-inspection.
Pay attention to the positive and
negative poles instruction in the
battery compartment and snap
the battery cover back onto the
device. Refer to the picture at right:
●Setting measure unit
In the shutdown state, long press the mode button
until the unit symbol flashes, then short press the
mode button to select the temperature units " " and
" ", and press the Power On/ Measure Button" "
to confirm.
●Body temperature mode (Measure temperature of
human body)
1. Point the infrared thermometer probe at the center
of the eyebrows and keep a distance of 0-3 cm from
the forehead (non-contact).
2. Press the Power On/ Measure Button" ". After
about 1 second, the infrared thermometer will have a
prompt of sound and display the measurement results.
When the measured result is beyond device
measurement range Body temperature mode:
22.0℃~43.0℃(71.6~109.4); the thermometer
will make one quick continuous sounds as "di-di-di"
to prompt, at the same time, " " or " " appears on
the display interface, accompanied by an orange
backlight.
●According to ISO 80601-2-56, Rated output
range: 34.0℃ to 42.0℃(93.2 to 107.6). Rated
extended output range: 22.0℃ to 33.9℃ (71.6 to
93.0) and 42.1℃ to 43.0℃ (107.6 to 109.4)
●Electric shock protection: the device is supplied by
internal power
●Operation mode: continuous operation
●Temperature units: ℃/
●Body temperature mode measuring site: forehead
●Time interval of each measurement ≤1s.
●Measurement time: ≤1s.
●Degrees of protection provided by enclosures
(IP code): IP22
●Safety classification: the device that cannot be
used in the presence of flammable anesthetic gases
mixed with air or oxygen or nitrous oxide
●Product size: 6" ×1.5"×1.7"
(152mm×38mm×43mm)
●Product weight: About 0.15 lbs. (70g) (not
including battery)
●Number of memory groups: 32 groups
●Service life: 5 years
●The thermometer uses an adjusted mode when
measuring the body temperature.
●Battery replacement cycle: use the new battery for
no less than 3000 measurements
●Wireless connection: Bluetooth
●Frequency range: 2.400 GHz~2.4835 GHz
●Modulation mode: GFSK
●Transmitting power: ≤20dBm
●FCC ID: 2A2JJ-YHW-6
Recommended Range: ~10 feet (~3 meters)
line-of-sight
Quality of Service (QoS): Delay <10 seconds
This thermometer meets ASTM Standard E
1965-98 requirements. Full responsibility for the
conformance of this device to the standard is
assumed by JIANGSU YUYUE MEDICAL &
SUPPLY CO.,LTD..
ASTM laboratory accuracy requirements for
infrared thermometer in the display range of 37℃
39℃ (98 102) is ±0.2℃(±0.4), while for
mercury-in-glass and electronic thermometers, the
requirement, according to ASTM Standards
E667-86 and E1112-86 is ±0.1℃ (±0.2).
●The clinical validation was conducted according to
the requirements of ISO 80601-2-56. Take the
result measured by mercury thermometer from oral
cavity as the reference. Test three groups: 0 to 1
year old, older than 1 year and younger than 5
years, older than 5 years. The minimum number of
subjects in an age group shall be at least 35. The
test results are shown in the table below:
●Appendix:
Instructions, 2 AAA alkaline batteries
APP Quick Guide(for YHW-6).
●The thermometer uses an infrared sensor, which
can sense the ambient temperature and the infrared
heat radiation emitted by the human body.Referring
to the corresponding parameter table, the best core
algorithm is used to calculate the accurate tempera-
ture.
●Intended purpose: This device is used to measure
the forehead temperature of the human body. It is
intended for use on people of all ages except
pre-term babies or very small(small for gestational
age) babies.
●Indication: Intermittent measurement of human
body temperature from forehead, not for emergency
clinical condition.
●Intended users: Intended users: Health care
professional, or lay persons at least 11 years old.
●Clinical benefits: The device can be used to
measure body temperature so as to help to diagnose
body condition. The clinical benefit associated with
the device is defined as indirect, all intended patient
population can experience the benefit.
●Contraindication: None.
●The device is for professional use and consumer
use.
●Patient can take measurement by themselves, or
they can be taken by someone else using a
thermometer. Patients can perform all the mainte-
nance.
1. Device Use And Applicant Scope
3. Warnings and Precautions
4. Measurement And Transport Storage
Environment
CAUTION: To avoid dust entering the probe cavity
resulting in inaccurate measurements, install the
cover after each use.
CAUTION: Do not use non-specified detachable parts
and materials, otherwise the product may not work
properly.
CAUTION: This thermometer is not intended to
interpret hypothermic temperatures. If the device
displays a temperature of 36.4℃ (97.5 ) or less, and
the individual is exhibiting atypical symptoms or
behaviors, contact your physician or health care
professional.
CAUTION: Do not mix old and new batteries.
CAUTION: When using the thermometer with a smart
device, keep both devices within the recommended
range of each other (see Specifications for details);
moving outside of this range may cause a loss in
connection with the smart device.
CAUTION: When using the thermometer with a smart
device, keep the devices away from sources that may
interfere with the Bluetooth connection. Other devices
may cause radio frequency interference (RFI), which
may result in a loss of quality of service (see
Specifications for details) for the Bluetooth connection.
Devices that may cause RFI include but are not limited
to: electrocautery equipment, diathermy equipment,
other cellular telephones, wireless PC and tablets,
pagers, RFID devices, MRI, and electromagnetic
security systems.
CAUTION: The user is cautioned that changes or
modifications not expressly approved by the party
responsible for compliance could void the user's
authority to operate the equipment
NOTE: 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.
NOTE: This equipment has been tested and found to
comply with the limits for a Class B digital device,
according to Part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against
harmful interference in a residential installation. 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 encouraged to try to correct the
interference by one or more of the following measures:
●Reorient or relocate the receiving antenna.
The
screen
display
" "
The operating
environment
temperature has
changed
significantly
compared to the
storage
temperature.
Place the
thermometer at
the operating
environment
temperature for
30 minutes
before use.
Manufacturer mark
Symbols
Caution
Recyclable
Manufacturer
Implication
This way up
Fragile, handle with care
Keep dry
Date of manufacture
Serial number
Batch code
Medical device
Protection from ingress of particulates than
12.5mm. Dripping water falling within 15° of
vertical will not have a harmful effect on the
thermometer per IEC 60529
Temperature limit
Humidity limitation
Unique device identifier
Refer to instruction manual
Atmospheric pressure limitation
Catalogue number
UDI
Non-ionizing radiation
Safety and environmental protection use period
for 10 years
Symbol for the marking of electrical and electronic
devices according to Directive 2012/19/EU
10
Bluetooth
MR Unsafe. Not appropriate for use in MR
environment (i.e.: inside the MR magnet room)
●Increase the separation between the equipment and
receiver.
●Consult the dealer or an experienced radio/TV
technician for help.
8. Symbols
background
WARNING: The measurement result is only for
reference, which is not a substitute for a physician's
diagnosis. It is very dangerous to self-judge and treat
only based on the measurement result. Please follow
the doctor's instructions.
WARNING: Please put the battery out of the reach of
children, otherwise it is dangerous.
WARNING: When the product is not used for a long time
(more than 3 months), remove the battery from device
to prevent the battery leakage.
WARNING: If there is a temperature difference between
the environment of the storage and that of the
measurement, place the device in the measuring
environment for more than 30 minutes, otherwise
there may be errors in the measurement results.
WARNING: It is forbidden to immerse the infrared
thermometer in any liquid, and it is forbidden to use it
for a long time under too high or low temperature
condition. No collisions, drops and mixing with sharp
objects.
WARNING: Do not put the battery close to the fire or into
the fire to avoid the battery explosion. Do not use the
battery when it leaks or molds. When discarding
batteries or this product, follow local regulations to
avoid contamination.
WARNING: This device contains sensitive electronic
components and should not be used in environments
with strong electromagnetic interference (e.g., mobile
phones, microwave ovens, etc.) to prevent temporary
impacts on its accuracy.
WARNING: Do not modify the device without authoriza-
tion from the manufacturer. If the device is damaged,
return the device to the manufacturer or distributor for
service.
WARNING: If the situations cannot be solved or
unexpected problem happens, please consult the local
01 03 0402
2. Device Structure and Composition
05 06 07
●Device main structure and composition
The thermometer consists of a housing, a sensor, a
display and a circuit board.
Detachable parts and materials for use: cover, 2
AAA alkaline batteries
Battery
Reminder
Temperature Unit
Sound Prompt
Body Temperature
Mode
Result Display
Object Temperature
Mode
Memory Mark
Phenomenon
of breakdown
The operating
environment
temperature is lower
than 10℃ (50.0)
When in body
temperature mode,
the measurement
result is >43.0℃
(109.4) or when in
the object
temperature mode,
the measurement
result is >60.0℃
(140.0)
The
screen
display
" "
The
screen
display
" "
Possible cause
Trouble shooting
methods
In the body
temperature mode,
the measurement
result is<22.0℃
(71.6) or in the
object temperature
mode, the
measurement result
is <0.0℃ (32.0)
The
screen
display
" "
The
screen
display
" "
The operating
environment
temperature is higher
than 40℃(104.0)
08 09
10
Power On/
Measure Button
LCD Display
Area
Temperature
Probe
Battery
Cover
Mode
Button
Memory
Button
MODE MEMO
distributor.
WARNING: Do not immerse this device in medical
alcohol or other liquids.
WARNING: Avoid contact between liquid and the
devices metal parts.
WARNING: Dispose of thermometer, accessories, and
battery per local laws and regulations.
WARNING: This device contains batteries and
recyclable electronic components. To protect the
environment, do not dispose of it with household
waste. Dispose of used batteries at an appropriate
collection location following national or local
regulations.
CAUTION: Do not try to measure when the device is
wet, which may cause measurement results
inaccurate.
CAUTION: Before measurement, please make sure
that there is no sweat, cosmetics or oil stains on the
forehead of subject. Please make sure that the subject
does not take a bath, exercise or have a meal within 30
minutes, and the body is measured at a steady state.
CAUTION: During measurement, do not let the subject
directly face sunlight, heater or the air outlet of air
conditioner, which will change the temperature of the
forehead. Please conduct measurement in a stable
environment as far as possible.
CAUTION: When the product gets wet due to contact
with steam, do not use until it get dry or be gently wiped
with a soft, dry cloth or cotton balls, otherwise it will
cause measurement errors.
CAUTION: For patients measuring their own tempera-
ture, it is recommended to measure close to the
forehead.
CAUTION: Please read this instruction carefully before
use and confirm that the battery is installed.
CAUTION: Do not move while using.
CAUTION: Under the combined effects of the environ-
ment and the frequency of use, the product's housing
temperature may exceed 41℃. Please use it carefully.
CAUTION: Please pay attention to product storage to
prevent damage caused by pets, pests or children.
CAUTION: This product is a high-precision device,
please do not drop the device! Avoid drastic collisions
and jolts and other adverse possibilities for transport.
CAUTION: Due to the limited size of the label, the font is
too small, please put it in the appropriate position to
watch.
CAUTION: Do not store this thermometer in tempera-
ture extremes below -20℃(-4) or over +55℃(131
) or in excessive humidity (below 15% or above 90%
non-condensing relative humidity).
CAUTION: Do not use this thermometer in temperature
extremes below 10℃(50) or over 40℃(104) or in
excessive humidity (below 15% or above 90%
non-condensing relative humidity).
●Measurement environment:
Temperature: 10℃ (50
) to 40℃ (104)
Relative humidity: 15% to 90% (no condensation)
Atmospheric pressure: 70kPa to 106kPa
●Transportation and storage environment:
Temperature: -20℃(-4
) to +55℃ (131)
Relative humidity: 15% to 90%(no condensation)
Atmospheric pressure: 70kPa to 106kPa
When body temperature is 37.6 ℃(99.7) or higher,
the device will make sounds as "di-di-di" to prompt.
●Object temperature mode (Measure temperature
of object)
Short press the mode button in the power-on state,
and the display icon flashes to switch between body
temperature mode and object temperature mode.
After selecting " "(object temperature mode),
approach the object to be measured and press the
Power On/ Measure Button " " to display the
measurement result.
When the measured result is beyond device
measurement range Object temperature mode:
0.0℃~60.0℃(32.0~140.0), the thermometer will
make sounds as "di-di-di" to prompt, at the same
time, " " or " " appears on the display interface.
Notes: Please make sure the measurement method
and the external environment is normal at this time.
●Memory function : press memory button, memory
value inquiry can be carried out. Thermometer can
store 32 groups of memory values. When the
number of groups exceeds the specified number, the
latest memory value will cover the earliest memory
value.
●In memory mode, press and hold memory button,
when CLr is displayed on the screen, the memory
value is cleared.
●Sound switch setting
Step 1: In the shutdown state, long press the mode
button until the temperature unit flashes.
Step 2: Then short press memory button to switch to
sound setting.
Step 3: Press mode button to select sound on " "
or sound off " ".
Step 4: Press the Power On/ Measure Button " " to
confirm.
●Power off
In the absence of any operation, the device will
automatically shut down within 2 minutes.
6. Cleaning and Disinfection
Manual cleaning procedure
1. Use a clean and dry soft cloth or cotton swab to
gently wipe the sensor lens for a minimum of 30
seconds.
2. Thoroughly wipe the device surfaces with a
non-linting cloth dampened (not dripping) with soap
solution for at least three (3) minutes. And wipe the
device surface with a non-linting cloth dampened
(not dripping) with bottled water for at least three (3)
minutes.
NOTE: Prepare the cleaning solution according to the
detergent manufacturers instructions. (e.g.,
Alconox
® Powdered Precision Cleaner, 10 g/L)
NOTE: Pay extra attention to the device's cracks,
crevices, and hard-to-reach areas.
3. Dry the device thoroughly with a soft, clean,
non-linting cloth.
Post-cleaning inspection
Inspect the device visually after cleaning for
cleanliness, damage, and missing or illegible device
labeling or markings:
1.If any visible dirt or residue remains, repeat the
cleaning procedure.
2.Any damaged device should be removed from use.
Damage may include, but is not limited to, corrosion,
discoloration, excessive scratches, flaking, cracks,
and wear.
3. Remove any device with missing, illegible device
labeling or marking from use.
Disinfection procedure
1. Clean the device before disinfection.
2. With the probe facing down, wipe the device
surfaces with a non-linting cloth dampened (not
dripping) with 70% Isopropyl Alcohol (IPA).
3. Allow all surfaces to remain wet for at least two (2)
minutes. If necessary, use additional wipes to
ensure the surfaces remain wet for the full duration.
4. Dry thoroughly with a soft, clean, non-linting cloth.
5. Allow at least five (5) minutes of drying before
taking a temperature reading. Make sure the probe
lens is clean and dry before use.
7. Troubleshooting Instructions
Replace with
new batteries
The
screen
display
" "
The power of
batteries is shortage
The
screen
display
" "
Please contact
the dealer and
send it to the
factory for repair
Infrared sensor
sampling error
Please
remeasure
following the
product
instruction
Place the infrared
thermometer at
an ambient
temperature of 10℃
to 40℃ (50 to
104) and let it
stand for 30
minutes before
measuring. If the
problem persists,
please contact
the dealer and
send it to the
factory for repair
No display
The batteries are
not installed well
Low battery
Check if the
batteries are
installed upside
down
Replace with
new batteries
Please contact
the dealer and
send it to the
factory for repair
The screen is
still blank
9. Technical Specification
●Power source: DC 3V (2×1.5V AAA alkaline batteries)
●Measurement range in body temperature mode:
22.0℃~43.0℃(71.6~109.4)
●Display resolution: 0.1℃(0.1)
●Measurement accuracy:±0.2℃(±0.4) in the
range of 35.0℃~42.0℃(95.0~107.6); ±0.3℃
(±0.5) in the range of 22.0℃~34.9℃(71.6
94.8) and 42.1℃~43.0℃(107.8~109.4)
The positive and
negative poles of the
batteries are
reversed or the
device is abnormal
Reinstall the
batteries, or
contact the
dealer
5. Setup and Use
●Installing the battery
The device is supplied with
2 AAA alkaline batteries. Push
the battery cover downward and
load the battery into the battery
compartment. At this time, the
device will start self-inspection.
Pay attention to the positive and
negative poles instruction in the
battery compartment and snap
the battery cover back onto the
device. Refer to the picture at right:
●Setting measure unit
In the shutdown state, long press the mode button
until the unit symbol flashes, then short press the
mode button to select the temperature units " " and
" ", and press the Power On/ Measure Button" "
to confirm.
●Body temperature mode (Measure temperature of
human body)
1. Point the infrared thermometer probe at the center
of the eyebrows and keep a distance of 0-3 cm from
the forehead (non-contact).
2. Press the Power On/ Measure Button" ". After
about 1 second, the infrared thermometer will have a
prompt of sound and display the measurement results.
When the measured result is beyond device
measurement range Body temperature mode:
22.0℃~43.0℃(71.6~109.4); the thermometer
will make one quick continuous sounds as "di-di-di"
to prompt, at the same time, " " or " " appears on
the display interface, accompanied by an orange
backlight.
●According to ISO 80601-2-56, Rated output
range: 34.0℃ to 42.0℃(93.2 to 107.6). Rated
extended output range: 22.0℃ to 33.9℃ (71.6 to
93.0) and 42.1℃ to 43.0℃ (107.6 to 109.4)
●Electric shock protection: the device is supplied by
internal power
●Operation mode: continuous operation
●Temperature units: ℃/
●Body temperature mode measuring site: forehead
●Time interval of each measurement ≤1s.
●Measurement time: ≤1s.
●Degrees of protection provided by enclosures
(IP code): IP22
●Safety classification: the device that cannot be
used in the presence of flammable anesthetic gases
mixed with air or oxygen or nitrous oxide
●Product size: 6" ×1.5"×1.7"
(152mm×38mm×43mm)
●Product weight: About 0.15 lbs. (70g) (not
including battery)
●Number of memory groups: 32 groups
●Service life: 5 years
●The thermometer uses an adjusted mode when
measuring the body temperature.
●Battery replacement cycle: use the new battery for
no less than 3000 measurements
●Wireless connection: Bluetooth
●Frequency range: 2.400 GHz~2.4835 GHz
●Modulation mode: GFSK
●Transmitting power: ≤20dBm
●FCC ID: 2A2JJ-YHW-6
Recommended Range: ~10 feet (~3 meters)
line-of-sight
Quality of Service (QoS): Delay <10 seconds
This thermometer meets ASTM Standard E
1965-98 requirements. Full responsibility for the
conformance of this device to the standard is
assumed by JIANGSU YUYUE MEDICAL &
SUPPLY CO.,LTD..
ASTM laboratory accuracy requirements for
infrared thermometer in the display range of 37℃
39℃ (98 102) is ±0.2℃(±0.4), while for
mercury-in-glass and electronic thermometers, the
requirement, according to ASTM Standards
E667-86 and E1112-86 is ±0.1℃ (±0.2).
●The clinical validation was conducted according to
the requirements of ISO 80601-2-56. Take the
result measured by mercury thermometer from oral
cavity as the reference. Test three groups: 0 to 1
year old, older than 1 year and younger than 5
years, older than 5 years. The minimum number of
subjects in an age group shall be at least 35. The
test results are shown in the table below:
●Appendix:
Instructions, 2 AAA alkaline batteries
APP Quick Guide(for YHW-6).
●The thermometer uses an infrared sensor, which
can sense the ambient temperature and the infrared
heat radiation emitted by the human body.Referring
to the corresponding parameter table, the best core
algorithm is used to calculate the accurate tempera-
ture.
●Intended purpose: This device is used to measure
the forehead temperature of the human body. It is
intended for use on people of all ages except
pre-term babies or very small(small for gestational
age) babies.
●Indication: Intermittent measurement of human
body temperature from forehead, not for emergency
clinical condition.
●Intended users: Intended users: Health care
professional, or lay persons at least 11 years old.
●Clinical benefits: The device can be used to
measure body temperature so as to help to diagnose
body condition. The clinical benefit associated with
the device is defined as indirect, all intended patient
population can experience the benefit.
●Contraindication: None.
●The device is for professional use and consumer
use.
●Patient can take measurement by themselves, or
they can be taken by someone else using a
thermometer. Patients can perform all the mainte-
nance.
1. Device Use And Applicant Scope
3. Warnings and Precautions
4. Measurement And Transport Storage
Environment
CAUTION: To avoid dust entering the probe cavity
resulting in inaccurate measurements, install the
cover after each use.
CAUTION: Do not use non-specified detachable parts
and materials, otherwise the product may not work
properly.
CAUTION: This thermometer is not intended to
interpret hypothermic temperatures. If the device
displays a temperature of 36.4℃ (97.5 ) or less, and
the individual is exhibiting atypical symptoms or
behaviors, contact your physician or health care
professional.
CAUTION: Do not mix old and new batteries.
CAUTION: When using the thermometer with a smart
device, keep both devices within the recommended
range of each other (see Specifications for details);
moving outside of this range may cause a loss in
connection with the smart device.
CAUTION: When using the thermometer with a smart
device, keep the devices away from sources that may
interfere with the Bluetooth connection. Other devices
may cause radio frequency interference (RFI), which
may result in a loss of quality of service (see
Specifications for details) for the Bluetooth connection.
Devices that may cause RFI include but are not limited
to: electrocautery equipment, diathermy equipment,
other cellular telephones, wireless PC and tablets,
pagers, RFID devices, MRI, and electromagnetic
security systems.
CAUTION: The user is cautioned that changes or
modifications not expressly approved by the party
responsible for compliance could void the user's
authority to operate the equipment
NOTE: 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.
NOTE: This equipment has been tested and found to
comply with the limits for a Class B digital device,
according to Part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against
harmful interference in a residential installation. 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 encouraged to try to correct the
interference by one or more of the following measures:
●Reorient or relocate the receiving antenna.
The
screen
display
" "
The operating
environment
temperature has
changed
significantly
compared to the
storage
temperature.
Place the
thermometer at
the operating
environment
temperature for
30 minutes
before use.
Manufacturer mark
Symbols
Caution
Recyclable
Manufacturer
Implication
This way up
Fragile, handle with care
Keep dry
Date of manufacture
Serial number
Batch code
Medical device
Protection from ingress of particulates than
12.5mm. Dripping water falling within 15° of
vertical will not have a harmful effect on the
thermometer per IEC 60529
Temperature limit
Humidity limitation
Unique device identifier
Refer to instruction manual
Atmospheric pressure limitation
Catalogue number
UDI
Non-ionizing radiation
Safety and environmental protection use period
for 10 years
Symbol for the marking of electrical and electronic
devices according to Directive 2012/19/EU
10
Bluetooth
MR Unsafe. Not appropriate for use in MR
environment (i.e.: inside the MR magnet room)
●Increase the separation between the equipment and
receiver.
●Consult the dealer or an experienced radio/TV
technician for help.
8. Symbols
background
WARNING: The measurement result is only for
reference, which is not a substitute for a physician's
diagnosis. It is very dangerous to self-judge and treat
only based on the measurement result. Please follow
the doctor's instructions.
WARNING: Please put the battery out of the reach of
children, otherwise it is dangerous.
WARNING: When the product is not used for a long time
(more than 3 months), remove the battery from device
to prevent the battery leakage.
WARNING: If there is a temperature difference between
the environment of the storage and that of the
measurement, place the device in the measuring
environment for more than 30 minutes, otherwise
there may be errors in the measurement results.
WARNING: It is forbidden to immerse the infrared
thermometer in any liquid, and it is forbidden to use it
for a long time under too high or low temperature
condition. No collisions, drops and mixing with sharp
objects.
WARNING: Do not put the battery close to the fire or into
the fire to avoid the battery explosion. Do not use the
battery when it leaks or molds. When discarding
batteries or this product, follow local regulations to
avoid contamination.
WARNING: This device contains sensitive electronic
components and should not be used in environments
with strong electromagnetic interference (e.g., mobile
phones, microwave ovens, etc.) to prevent temporary
impacts on its accuracy.
WARNING: Do not modify the device without authoriza-
tion from the manufacturer. If the device is damaged,
return the device to the manufacturer or distributor for
service.
WARNING: If the situations cannot be solved or
unexpected problem happens, please consult the local
01 03 0402
2. Device Structure and Composition
05 06 07
●Device main structure and composition
The thermometer consists of a housing, a sensor, a
display and a circuit board.
Detachable parts and materials for use: cover, 2
AAA alkaline batteries
Battery
Reminder
Temperature Unit
Sound Prompt
Body Temperature
Mode
Result Display
Object Temperature
Mode
Memory Mark
Phenomenon
of breakdown
The operating
environment
temperature is lower
than 10℃ (50.0)
When in body
temperature mode,
the measurement
result is >43.0℃
(109.4) or when in
the object
temperature mode,
the measurement
result is >60.0℃
(140.0)
The
screen
display
" "
The
screen
display
" "
Possible cause
Trouble shooting
methods
In the body
temperature mode,
the measurement
result is<22.0℃
(71.6) or in the
object temperature
mode, the
measurement result
is <0.0℃ (32.0)
The
screen
display
" "
The
screen
display
" "
The operating
environment
temperature is higher
than 40℃(104.0)
08 09
10
Power On/
Measure Button
LCD Display
Area
Temperature
Probe
Battery
Cover
Mode
Button
Memory
Button
MODE MEMO
distributor.
WARNING: Do not immerse this device in medical
alcohol or other liquids.
WARNING: Avoid contact between liquid and the
devices metal parts.
WARNING: Dispose of thermometer, accessories, and
battery per local laws and regulations.
WARNING: This device contains batteries and
recyclable electronic components. To protect the
environment, do not dispose of it with household
waste. Dispose of used batteries at an appropriate
collection location following national or local
regulations.
CAUTION: Do not try to measure when the device is
wet, which may cause measurement results
inaccurate.
CAUTION: Before measurement, please make sure
that there is no sweat, cosmetics or oil stains on the
forehead of subject. Please make sure that the subject
does not take a bath, exercise or have a meal within 30
minutes, and the body is measured at a steady state.
CAUTION: During measurement, do not let the subject
directly face sunlight, heater or the air outlet of air
conditioner, which will change the temperature of the
forehead. Please conduct measurement in a stable
environment as far as possible.
CAUTION: When the product gets wet due to contact
with steam, do not use until it get dry or be gently wiped
with a soft, dry cloth or cotton balls, otherwise it will
cause measurement errors.
CAUTION: For patients measuring their own tempera-
ture, it is recommended to measure close to the
forehead.
CAUTION: Please read this instruction carefully before
use and confirm that the battery is installed.
CAUTION: Do not move while using.
CAUTION: Under the combined effects of the environ-
ment and the frequency of use, the product's housing
temperature may exceed 41℃. Please use it carefully.
CAUTION: Please pay attention to product storage to
prevent damage caused by pets, pests or children.
CAUTION: This product is a high-precision device,
please do not drop the device! Avoid drastic collisions
and jolts and other adverse possibilities for transport.
CAUTION: Due to the limited size of the label, the font is
too small, please put it in the appropriate position to
watch.
CAUTION: Do not store this thermometer in tempera-
ture extremes below -20℃(-4) or over +55℃(131
) or in excessive humidity (below 15% or above 90%
non-condensing relative humidity).
CAUTION: Do not use this thermometer in temperature
extremes below 10℃(50) or over 40℃(104) or in
excessive humidity (below 15% or above 90%
non-condensing relative humidity).
●Measurement environment:
Temperature: 10℃ (50
) to 40℃ (104)
Relative humidity: 15% to 90% (no condensation)
Atmospheric pressure: 70kPa to 106kPa
●Transportation and storage environment:
Temperature: -20℃(-4
) to +55℃ (131)
Relative humidity: 15% to 90%(no condensation)
Atmospheric pressure: 70kPa to 106kPa
When body temperature is 37.6 ℃(99.7) or higher,
the device will make sounds as "di-di-di" to prompt.
●Object temperature mode (Measure temperature
of object)
Short press the mode button in the power-on state,
and the display icon flashes to switch between body
temperature mode and object temperature mode.
After selecting " "(object temperature mode),
approach the object to be measured and press the
Power On/ Measure Button " " to display the
measurement result.
When the measured result is beyond device
measurement range Object temperature mode:
0.0℃~60.0℃(32.0~140.0), the thermometer will
make sounds as "di-di-di" to prompt, at the same
time, " " or " " appears on the display interface.
Notes: Please make sure the measurement method
and the external environment is normal at this time.
●Memory function : press memory button, memory
value inquiry can be carried out. Thermometer can
store 32 groups of memory values. When the
number of groups exceeds the specified number, the
latest memory value will cover the earliest memory
value.
●In memory mode, press and hold memory button,
when CLr is displayed on the screen, the memory
value is cleared.
●Sound switch setting
Step 1: In the shutdown state, long press the mode
button until the temperature unit flashes.
Step 2: Then short press memory button to switch to
sound setting.
Step 3: Press mode button to select sound on " "
or sound off " ".
Step 4: Press the Power On/ Measure Button " " to
confirm.
●Power off
In the absence of any operation, the device will
automatically shut down within 2 minutes.
6. Cleaning and Disinfection
Manual cleaning procedure
1. Use a clean and dry soft cloth or cotton swab to
gently wipe the sensor lens for a minimum of 30
seconds.
2. Thoroughly wipe the device surfaces with a
non-linting cloth dampened (not dripping) with soap
solution for at least three (3) minutes. And wipe the
device surface with a non-linting cloth dampened
(not dripping) with bottled water for at least three (3)
minutes.
NOTE: Prepare the cleaning solution according to the
detergent manufacturers instructions. (e.g.,
Alconox
® Powdered Precision Cleaner, 10 g/L)
NOTE: Pay extra attention to the device's cracks,
crevices, and hard-to-reach areas.
3. Dry the device thoroughly with a soft, clean,
non-linting cloth.
Post-cleaning inspection
Inspect the device visually after cleaning for
cleanliness, damage, and missing or illegible device
labeling or markings:
1.If any visible dirt or residue remains, repeat the
cleaning procedure.
2.Any damaged device should be removed from use.
Damage may include, but is not limited to, corrosion,
discoloration, excessive scratches, flaking, cracks,
and wear.
3. Remove any device with missing, illegible device
labeling or marking from use.
Disinfection procedure
1. Clean the device before disinfection.
2. With the probe facing down, wipe the device
surfaces with a non-linting cloth dampened (not
dripping) with 70% Isopropyl Alcohol (IPA).
3. Allow all surfaces to remain wet for at least two (2)
minutes. If necessary, use additional wipes to
ensure the surfaces remain wet for the full duration.
4. Dry thoroughly with a soft, clean, non-linting cloth.
5. Allow at least five (5) minutes of drying before
taking a temperature reading. Make sure the probe
lens is clean and dry before use.
7. Troubleshooting Instructions
Replace with
new batteries
The
screen
display
" "
The power of
batteries is shortage
The
screen
display
" "
Please contact
the dealer and
send it to the
factory for repair
Infrared sensor
sampling error
Please
remeasure
following the
product
instruction
Place the infrared
thermometer at
an ambient
temperature of 10℃
to 40℃ (50 to
104) and let it
stand for 30
minutes before
measuring. If the
problem persists,
please contact
the dealer and
send it to the
factory for repair
No display
The batteries are
not installed well
Low battery
Check if the
batteries are
installed upside
down
Replace with
new batteries
Please contact
the dealer and
send it to the
factory for repair
The screen is
still blank
9. Technical Specification
●Power source: DC 3V (2×1.5V AAA alkaline batteries)
●Measurement range in body temperature mode:
22.0℃~43.0℃(71.6~109.4)
●Display resolution: 0.1℃(0.1)
●Measurement accuracy:±0.2℃(±0.4) in the
range of 35.0℃~42.0℃(95.0~107.6); ±0.3℃
(±0.5) in the range of 22.0℃~34.9℃(71.6
94.8) and 42.1℃~43.0℃(107.8~109.4)
The positive and
negative poles of the
batteries are
reversed or the
device is abnormal
Reinstall the
batteries, or
contact the
dealer
5. Setup and Use
●Installing the battery
The device is supplied with
2 AAA alkaline batteries. Push
the battery cover downward and
load the battery into the battery
compartment. At this time, the
device will start self-inspection.
Pay attention to the positive and
negative poles instruction in the
battery compartment and snap
the battery cover back onto the
device. Refer to the picture at right:
●Setting measure unit
In the shutdown state, long press the mode button
until the unit symbol flashes, then short press the
mode button to select the temperature units " " and
" ", and press the Power On/ Measure Button" "
to confirm.
●Body temperature mode (Measure temperature of
human body)
1. Point the infrared thermometer probe at the center
of the eyebrows and keep a distance of 0-3 cm from
the forehead (non-contact).
2. Press the Power On/ Measure Button" ". After
about 1 second, the infrared thermometer will have a
prompt of sound and display the measurement results.
When the measured result is beyond device
measurement range Body temperature mode:
22.0℃~43.0℃(71.6~109.4); the thermometer
will make one quick continuous sounds as "di-di-di"
to prompt, at the same time, " " or " " appears on
the display interface, accompanied by an orange
backlight.
●According to ISO 80601-2-56, Rated output
range: 34.0℃ to 42.0℃(93.2 to 107.6). Rated
extended output range: 22.0℃ to 33.9℃ (71.6 to
93.0) and 42.1℃ to 43.0℃ (107.6 to 109.4)
●Electric shock protection: the device is supplied by
internal power
●Operation mode: continuous operation
●Temperature units: ℃/
●Body temperature mode measuring site: forehead
●Time interval of each measurement ≤1s.
●Measurement time: ≤1s.
●Degrees of protection provided by enclosures
(IP code): IP22
●Safety classification: the device that cannot be
used in the presence of flammable anesthetic gases
mixed with air or oxygen or nitrous oxide
●Product size: 6" ×1.5"×1.7"
(152mm×38mm×43mm)
●Product weight: About 0.15 lbs. (70g) (not
including battery)
●Number of memory groups: 32 groups
●Service life: 5 years
●The thermometer uses an adjusted mode when
measuring the body temperature.
●Battery replacement cycle: use the new battery for
no less than 3000 measurements
●Wireless connection: Bluetooth
●Frequency range: 2.400 GHz~2.4835 GHz
●Modulation mode: GFSK
●Transmitting power: ≤20dBm
●FCC ID: 2A2JJ-YHW-6
Recommended Range: ~10 feet (~3 meters)
line-of-sight
Quality of Service (QoS): Delay <10 seconds
This thermometer meets ASTM Standard E
1965-98 requirements. Full responsibility for the
conformance of this device to the standard is
assumed by JIANGSU YUYUE MEDICAL &
SUPPLY CO.,LTD..
ASTM laboratory accuracy requirements for
infrared thermometer in the display range of 37℃
39℃ (98 102) is ±0.2℃(±0.4), while for
mercury-in-glass and electronic thermometers, the
requirement, according to ASTM Standards
E667-86 and E1112-86 is ±0.1℃ (±0.2).
●The clinical validation was conducted according to
the requirements of ISO 80601-2-56. Take the
result measured by mercury thermometer from oral
cavity as the reference. Test three groups: 0 to 1
year old, older than 1 year and younger than 5
years, older than 5 years. The minimum number of
subjects in an age group shall be at least 35. The
test results are shown in the table below:
●Appendix:
Instructions, 2 AAA alkaline batteries
APP Quick Guide(for YHW-6).
●The thermometer uses an infrared sensor, which
can sense the ambient temperature and the infrared
heat radiation emitted by the human body.Referring
to the corresponding parameter table, the best core
algorithm is used to calculate the accurate tempera-
ture.
●Intended purpose: This device is used to measure
the forehead temperature of the human body. It is
intended for use on people of all ages except
pre-term babies or very small(small for gestational
age) babies.
●Indication: Intermittent measurement of human
body temperature from forehead, not for emergency
clinical condition.
●Intended users: Intended users: Health care
professional, or lay persons at least 11 years old.
●Clinical benefits: The device can be used to
measure body temperature so as to help to diagnose
body condition. The clinical benefit associated with
the device is defined as indirect, all intended patient
population can experience the benefit.
●Contraindication: None.
●The device is for professional use and consumer
use.
●Patient can take measurement by themselves, or
they can be taken by someone else using a
thermometer. Patients can perform all the mainte-
nance.
1. Device Use And Applicant Scope
3. Warnings and Precautions
4. Measurement And Transport Storage
Environment
CAUTION: To avoid dust entering the probe cavity
resulting in inaccurate measurements, install the
cover after each use.
CAUTION: Do not use non-specified detachable parts
and materials, otherwise the product may not work
properly.
CAUTION: This thermometer is not intended to
interpret hypothermic temperatures. If the device
displays a temperature of 36.4℃ (97.5 ) or less, and
the individual is exhibiting atypical symptoms or
behaviors, contact your physician or health care
professional.
CAUTION: Do not mix old and new batteries.
CAUTION: When using the thermometer with a smart
device, keep both devices within the recommended
range of each other (see Specifications for details);
moving outside of this range may cause a loss in
connection with the smart device.
CAUTION: When using the thermometer with a smart
device, keep the devices away from sources that may
interfere with the Bluetooth connection. Other devices
may cause radio frequency interference (RFI), which
may result in a loss of quality of service (see
Specifications for details) for the Bluetooth connection.
Devices that may cause RFI include but are not limited
to: electrocautery equipment, diathermy equipment,
other cellular telephones, wireless PC and tablets,
pagers, RFID devices, MRI, and electromagnetic
security systems.
CAUTION: The user is cautioned that changes or
modifications not expressly approved by the party
responsible for compliance could void the user's
authority to operate the equipment
NOTE: 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.
NOTE: This equipment has been tested and found to
comply with the limits for a Class B digital device,
according to Part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against
harmful interference in a residential installation. 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 encouraged to try to correct the
interference by one or more of the following measures:
●Reorient or relocate the receiving antenna.
The
screen
display
" "
The operating
environment
temperature has
changed
significantly
compared to the
storage
temperature.
Place the
thermometer at
the operating
environment
temperature for
30 minutes
before use.
Manufacturer mark
Symbols
Caution
Recyclable
Manufacturer
Implication
This way up
Fragile, handle with care
Keep dry
Date of manufacture
Serial number
Batch code
Medical device
Protection from ingress of particulates than
12.5mm. Dripping water falling within 15° of
vertical will not have a harmful effect on the
thermometer per IEC 60529
Temperature limit
Humidity limitation
Unique device identifier
Refer to instruction manual
Atmospheric pressure limitation
Catalogue number
UDI
Non-ionizing radiation
Safety and environmental protection use period
for 10 years
Symbol for the marking of electrical and electronic
devices according to Directive 2012/19/EU
10
Bluetooth
MR Unsafe. Not appropriate for use in MR
environment (i.e.: inside the MR magnet room)
●Increase the separation between the equipment and
receiver.
●Consult the dealer or an experienced radio/TV
technician for help.
8. Symbols
background
WARNING: The measurement result is only for
reference, which is not a substitute for a physician's
diagnosis. It is very dangerous to self-judge and treat
only based on the measurement result. Please follow
the doctor's instructions.
WARNING: Please put the battery out of the reach of
children, otherwise it is dangerous.
WARNING: When the product is not used for a long time
(more than 3 months), remove the battery from device
to prevent the battery leakage.
WARNING: If there is a temperature difference between
the environment of the storage and that of the
measurement, place the device in the measuring
environment for more than 30 minutes, otherwise
there may be errors in the measurement results.
WARNING: It is forbidden to immerse the infrared
thermometer in any liquid, and it is forbidden to use it
for a long time under too high or low temperature
condition. No collisions, drops and mixing with sharp
objects.
WARNING: Do not put the battery close to the fire or into
the fire to avoid the battery explosion. Do not use the
battery when it leaks or molds. When discarding
batteries or this product, follow local regulations to
avoid contamination.
WARNING: This device contains sensitive electronic
components and should not be used in environments
with strong electromagnetic interference (e.g., mobile
phones, microwave ovens, etc.) to prevent temporary
impacts on its accuracy.
WARNING: Do not modify the device without authoriza-
tion from the manufacturer. If the device is damaged,
return the device to the manufacturer or distributor for
service.
WARNING: If the situations cannot be solved or
unexpected problem happens, please consult the local
01 03 0402
2. Device Structure and Composition
05 06 07
●Device main structure and composition
The thermometer consists of a housing, a sensor, a
display and a circuit board.
Detachable parts and materials for use: cover, 2
AAA alkaline batteries
Battery
Reminder
Temperature Unit
Sound Prompt
Body Temperature
Mode
Result Display
Object Temperature
Mode
Memory Mark
Phenomenon
of breakdown
The operating
environment
temperature is lower
than 10℃ (50.0)
When in body
temperature mode,
the measurement
result is >43.0℃
(109.4) or when in
the object
temperature mode,
the measurement
result is >60.0℃
(140.0)
The
screen
display
" "
The
screen
display
" "
Possible cause
Trouble shooting
methods
In the body
temperature mode,
the measurement
result is<22.0℃
(71.6) or in the
object temperature
mode, the
measurement result
is <0.0℃ (32.0)
The
screen
display
" "
The
screen
display
" "
The operating
environment
temperature is higher
than 40℃(104.0)
08 09
10
Power On/
Measure Button
LCD Display
Area
Temperature
Probe
Battery
Cover
Mode
Button
Memory
Button
MODE MEMO
distributor.
WARNING: Do not immerse this device in medical
alcohol or other liquids.
WARNING: Avoid contact between liquid and the
devices metal parts.
WARNING: Dispose of thermometer, accessories, and
battery per local laws and regulations.
WARNING: This device contains batteries and
recyclable electronic components. To protect the
environment, do not dispose of it with household
waste. Dispose of used batteries at an appropriate
collection location following national or local
regulations.
CAUTION: Do not try to measure when the device is
wet, which may cause measurement results
inaccurate.
CAUTION: Before measurement, please make sure
that there is no sweat, cosmetics or oil stains on the
forehead of subject. Please make sure that the subject
does not take a bath, exercise or have a meal within 30
minutes, and the body is measured at a steady state.
CAUTION: During measurement, do not let the subject
directly face sunlight, heater or the air outlet of air
conditioner, which will change the temperature of the
forehead. Please conduct measurement in a stable
environment as far as possible.
CAUTION: When the product gets wet due to contact
with steam, do not use until it get dry or be gently wiped
with a soft, dry cloth or cotton balls, otherwise it will
cause measurement errors.
CAUTION: For patients measuring their own tempera-
ture, it is recommended to measure close to the
forehead.
CAUTION: Please read this instruction carefully before
use and confirm that the battery is installed.
CAUTION: Do not move while using.
CAUTION: Under the combined effects of the environ-
ment and the frequency of use, the product's housing
temperature may exceed 41℃. Please use it carefully.
CAUTION: Please pay attention to product storage to
prevent damage caused by pets, pests or children.
CAUTION: This product is a high-precision device,
please do not drop the device! Avoid drastic collisions
and jolts and other adverse possibilities for transport.
CAUTION: Due to the limited size of the label, the font is
too small, please put it in the appropriate position to
watch.
CAUTION: Do not store this thermometer in tempera-
ture extremes below -20℃(-4) or over +55℃(131
) or in excessive humidity (below 15% or above 90%
non-condensing relative humidity).
CAUTION: Do not use this thermometer in temperature
extremes below 10℃(50) or over 40℃(104) or in
excessive humidity (below 15% or above 90%
non-condensing relative humidity).
●Measurement environment:
Temperature: 10℃ (50
) to 40℃ (104)
Relative humidity: 15% to 90% (no condensation)
Atmospheric pressure: 70kPa to 106kPa
●Transportation and storage environment:
Temperature: -20℃(-4
) to +55℃ (131)
Relative humidity: 15% to 90%(no condensation)
Atmospheric pressure: 70kPa to 106kPa
When body temperature is 37.6 ℃(99.7) or higher,
the device will make sounds as "di-di-di" to prompt.
●Object temperature mode (Measure temperature
of object)
Short press the mode button in the power-on state,
and the display icon flashes to switch between body
temperature mode and object temperature mode.
After selecting " "(object temperature mode),
approach the object to be measured and press the
Power On/ Measure Button " " to display the
measurement result.
When the measured result is beyond device
measurement range Object temperature mode:
0.0℃~60.0℃(32.0~140.0), the thermometer will
make sounds as "di-di-di" to prompt, at the same
time, " " or " " appears on the display interface.
Notes: Please make sure the measurement method
and the external environment is normal at this time.
●Memory function : press memory button, memory
value inquiry can be carried out. Thermometer can
store 32 groups of memory values. When the
number of groups exceeds the specified number, the
latest memory value will cover the earliest memory
value.
●In memory mode, press and hold memory button,
when CLr is displayed on the screen, the memory
value is cleared.
●Sound switch setting
Step 1: In the shutdown state, long press the mode
button until the temperature unit flashes.
Step 2: Then short press memory button to switch to
sound setting.
Step 3: Press mode button to select sound on " "
or sound off " ".
Step 4: Press the Power On/ Measure Button " " to
confirm.
●Power off
In the absence of any operation, the device will
automatically shut down within 2 minutes.
6. Cleaning and Disinfection
Manual cleaning procedure
1. Use a clean and dry soft cloth or cotton swab to
gently wipe the sensor lens for a minimum of 30
seconds.
2. Thoroughly wipe the device surfaces with a
non-linting cloth dampened (not dripping) with soap
solution for at least three (3) minutes. And wipe the
device surface with a non-linting cloth dampened
(not dripping) with bottled water for at least three (3)
minutes.
NOTE: Prepare the cleaning solution according to the
detergent manufacturers instructions. (e.g.,
Alconox
® Powdered Precision Cleaner, 10 g/L)
NOTE: Pay extra attention to the device's cracks,
crevices, and hard-to-reach areas.
3. Dry the device thoroughly with a soft, clean,
non-linting cloth.
Post-cleaning inspection
Inspect the device visually after cleaning for
cleanliness, damage, and missing or illegible device
labeling or markings:
1.If any visible dirt or residue remains, repeat the
cleaning procedure.
2.Any damaged device should be removed from use.
Damage may include, but is not limited to, corrosion,
discoloration, excessive scratches, flaking, cracks,
and wear.
3. Remove any device with missing, illegible device
labeling or marking from use.
Disinfection procedure
1. Clean the device before disinfection.
2. With the probe facing down, wipe the device
surfaces with a non-linting cloth dampened (not
dripping) with 70% Isopropyl Alcohol (IPA).
3. Allow all surfaces to remain wet for at least two (2)
minutes. If necessary, use additional wipes to
ensure the surfaces remain wet for the full duration.
4. Dry thoroughly with a soft, clean, non-linting cloth.
5. Allow at least five (5) minutes of drying before
taking a temperature reading. Make sure the probe
lens is clean and dry before use.
7. Troubleshooting Instructions
Replace with
new batteries
The
screen
display
" "
The power of
batteries is shortage
The
screen
display
" "
Please contact
the dealer and
send it to the
factory for repair
Infrared sensor
sampling error
Please
remeasure
following the
product
instruction
Place the infrared
thermometer at
an ambient
temperature of 10℃
to 40℃ (50 to
104) and let it
stand for 30
minutes before
measuring. If the
problem persists,
please contact
the dealer and
send it to the
factory for repair
No display
The batteries are
not installed well
Low battery
Check if the
batteries are
installed upside
down
Replace with
new batteries
Please contact
the dealer and
send it to the
factory for repair
The screen is
still blank
9. Technical Specification
●Power source: DC 3V (2×1.5V AAA alkaline batteries)
●Measurement range in body temperature mode:
22.0℃~43.0℃(71.6~109.4)
●Display resolution: 0.1℃(0.1)
●Measurement accuracy:±0.2℃(±0.4) in the
range of 35.0℃~42.0℃(95.0~107.6); ±0.3℃
(±0.5) in the range of 22.0℃~34.9℃(71.6
94.8) and 42.1℃~43.0℃(107.8~109.4)
The positive and
negative poles of the
batteries are
reversed or the
device is abnormal
Reinstall the
batteries, or
contact the
dealer
5. Setup and Use
●Installing the battery
The device is supplied with
2 AAA alkaline batteries. Push
the battery cover downward and
load the battery into the battery
compartment. At this time, the
device will start self-inspection.
Pay attention to the positive and
negative poles instruction in the
battery compartment and snap
the battery cover back onto the
device. Refer to the picture at right:
●Setting measure unit
In the shutdown state, long press the mode button
until the unit symbol flashes, then short press the
mode button to select the temperature units " " and
" ", and press the Power On/ Measure Button" "
to confirm.
●Body temperature mode (Measure temperature of
human body)
1. Point the infrared thermometer probe at the center
of the eyebrows and keep a distance of 0-3 cm from
the forehead (non-contact).
2. Press the Power On/ Measure Button" ". After
about 1 second, the infrared thermometer will have a
prompt of sound and display the measurement results.
When the measured result is beyond device
measurement range Body temperature mode:
22.0℃~43.0℃(71.6~109.4); the thermometer
will make one quick continuous sounds as "di-di-di"
to prompt, at the same time, " " or " " appears on
the display interface, accompanied by an orange
backlight.
●According to ISO 80601-2-56, Rated output
range: 34.0℃ to 42.0℃(93.2 to 107.6). Rated
extended output range: 22.0℃ to 33.9℃ (71.6 to
93.0) and 42.1℃ to 43.0℃ (107.6 to 109.4)
●Electric shock protection: the device is supplied by
internal power
●Operation mode: continuous operation
●Temperature units: ℃/
●Body temperature mode measuring site: forehead
●Time interval of each measurement ≤1s.
●Measurement time: ≤1s.
●Degrees of protection provided by enclosures
(IP code): IP22
●Safety classification: the device that cannot be
used in the presence of flammable anesthetic gases
mixed with air or oxygen or nitrous oxide
●Product size: 6" ×1.5"×1.7"
(152mm×38mm×43mm)
●Product weight: About 0.15 lbs. (70g) (not
including battery)
●Number of memory groups: 32 groups
●Service life: 5 years
●The thermometer uses an adjusted mode when
measuring the body temperature.
●Battery replacement cycle: use the new battery for
no less than 3000 measurements
●Wireless connection: Bluetooth
●Frequency range: 2.400 GHz~2.4835 GHz
●Modulation mode: GFSK
●Transmitting power: ≤20dBm
●FCC ID: 2A2JJ-YHW-6
Recommended Range: ~10 feet (~3 meters)
line-of-sight
Quality of Service (QoS): Delay <10 seconds
This thermometer meets ASTM Standard E
1965-98 requirements. Full responsibility for the
conformance of this device to the standard is
assumed by JIANGSU YUYUE MEDICAL &
SUPPLY CO.,LTD..
ASTM laboratory accuracy requirements for
infrared thermometer in the display range of 37℃
39℃ (98 102) is ±0.2℃(±0.4), while for
mercury-in-glass and electronic thermometers, the
requirement, according to ASTM Standards
E667-86 and E1112-86 is ±0.1℃ (±0.2).
●The clinical validation was conducted according to
the requirements of ISO 80601-2-56. Take the
result measured by mercury thermometer from oral
cavity as the reference. Test three groups: 0 to 1
year old, older than 1 year and younger than 5
years, older than 5 years. The minimum number of
subjects in an age group shall be at least 35. The
test results are shown in the table below:
●Appendix:
Instructions, 2 AAA alkaline batteries
APP Quick Guide(for YHW-6).
●The thermometer uses an infrared sensor, which
can sense the ambient temperature and the infrared
heat radiation emitted by the human body.Referring
to the corresponding parameter table, the best core
algorithm is used to calculate the accurate tempera-
ture.
●Intended purpose: This device is used to measure
the forehead temperature of the human body. It is
intended for use on people of all ages except
pre-term babies or very small(small for gestational
age) babies.
●Indication: Intermittent measurement of human
body temperature from forehead, not for emergency
clinical condition.
●Intended users: Intended users: Health care
professional, or lay persons at least 11 years old.
●Clinical benefits: The device can be used to
measure body temperature so as to help to diagnose
body condition. The clinical benefit associated with
the device is defined as indirect, all intended patient
population can experience the benefit.
●Contraindication: None.
●The device is for professional use and consumer
use.
●Patient can take measurement by themselves, or
they can be taken by someone else using a
thermometer. Patients can perform all the mainte-
nance.
1. Device Use And Applicant Scope
3. Warnings and Precautions
4. Measurement And Transport Storage
Environment
CAUTION: To avoid dust entering the probe cavity
resulting in inaccurate measurements, install the
cover after each use.
CAUTION: Do not use non-specified detachable parts
and materials, otherwise the product may not work
properly.
CAUTION: This thermometer is not intended to
interpret hypothermic temperatures. If the device
displays a temperature of 36.4℃ (97.5 ) or less, and
the individual is exhibiting atypical symptoms or
behaviors, contact your physician or health care
professional.
CAUTION: Do not mix old and new batteries.
CAUTION: When using the thermometer with a smart
device, keep both devices within the recommended
range of each other (see Specifications for details);
moving outside of this range may cause a loss in
connection with the smart device.
CAUTION: When using the thermometer with a smart
device, keep the devices away from sources that may
interfere with the Bluetooth connection. Other devices
may cause radio frequency interference (RFI), which
may result in a loss of quality of service (see
Specifications for details) for the Bluetooth connection.
Devices that may cause RFI include but are not limited
to: electrocautery equipment, diathermy equipment,
other cellular telephones, wireless PC and tablets,
pagers, RFID devices, MRI, and electromagnetic
security systems.
CAUTION: The user is cautioned that changes or
modifications not expressly approved by the party
responsible for compliance could void the user's
authority to operate the equipment
NOTE: 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.
NOTE: This equipment has been tested and found to
comply with the limits for a Class B digital device,
according to Part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against
harmful interference in a residential installation. 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 encouraged to try to correct the
interference by one or more of the following measures:
●Reorient or relocate the receiving antenna.
The
screen
display
" "
The operating
environment
temperature has
changed
significantly
compared to the
storage
temperature.
Place the
thermometer at
the operating
environment
temperature for
30 minutes
before use.
Manufacturer mark
Symbols
Caution
Recyclable
Manufacturer
Implication
This way up
Fragile, handle with care
Keep dry
Date of manufacture
Serial number
Batch code
Medical device
Protection from ingress of particulates than
12.5mm. Dripping water falling within 15° of
vertical will not have a harmful effect on the
thermometer per IEC 60529
Temperature limit
Humidity limitation
Unique device identifier
Refer to instruction manual
Atmospheric pressure limitation
Catalogue number
UDI
Non-ionizing radiation
Safety and environmental protection use period
for 10 years
Symbol for the marking of electrical and electronic
devices according to Directive 2012/19/EU
10
Bluetooth
MR Unsafe. Not appropriate for use in MR
environment (i.e.: inside the MR magnet room)
●Increase the separation between the equipment and
receiver.
●Consult the dealer or an experienced radio/TV
technician for help.
8. Symbols
background
WARNING: The measurement result is only for
reference, which is not a substitute for a physician's
diagnosis. It is very dangerous to self-judge and treat
only based on the measurement result. Please follow
the doctor's instructions.
WARNING: Please put the battery out of the reach of
children, otherwise it is dangerous.
WARNING: When the product is not used for a long time
(more than 3 months), remove the battery from device
to prevent the battery leakage.
WARNING: If there is a temperature difference between
the environment of the storage and that of the
measurement, place the device in the measuring
environment for more than 30 minutes, otherwise
there may be errors in the measurement results.
WARNING: It is forbidden to immerse the infrared
thermometer in any liquid, and it is forbidden to use it
for a long time under too high or low temperature
condition. No collisions, drops and mixing with sharp
objects.
WARNING: Do not put the battery close to the fire or into
the fire to avoid the battery explosion. Do not use the
battery when it leaks or molds. When discarding
batteries or this product, follow local regulations to
avoid contamination.
WARNING: This device contains sensitive electronic
components and should not be used in environments
with strong electromagnetic interference (e.g., mobile
phones, microwave ovens, etc.) to prevent temporary
impacts on its accuracy.
WARNING: Do not modify the device without authoriza-
tion from the manufacturer. If the device is damaged,
return the device to the manufacturer or distributor for
service.
WARNING: If the situations cannot be solved or
unexpected problem happens, please consult the local
01 03 0402
2. Device Structure and Composition
05 06 07
●Device main structure and composition
The thermometer consists of a housing, a sensor, a
display and a circuit board.
Detachable parts and materials for use: cover, 2
AAA alkaline batteries
Battery
Reminder
Temperature Unit
Sound Prompt
Body Temperature
Mode
Result Display
Object Temperature
Mode
Memory Mark
Phenomenon
of breakdown
The operating
environment
temperature is lower
than 10℃ (50.0)
When in body
temperature mode,
the measurement
result is >43.0℃
(109.4) or when in
the object
temperature mode,
the measurement
result is >60.0℃
(140.0)
The
screen
display
" "
The
screen
display
" "
Possible cause
Trouble shooting
methods
In the body
temperature mode,
the measurement
result is<22.0℃
(71.6) or in the
object temperature
mode, the
measurement result
is <0.0℃ (32.0)
The
screen
display
" "
The
screen
display
" "
The operating
environment
temperature is higher
than 40℃(104.0)
08 09
10
Power On/
Measure Button
LCD Display
Area
Temperature
Probe
Battery
Cover
Mode
Button
Memory
Button
MODE MEMO
distributor.
WARNING: Do not immerse this device in medical
alcohol or other liquids.
WARNING: Avoid contact between liquid and the
devices metal parts.
WARNING: Dispose of thermometer, accessories, and
battery per local laws and regulations.
WARNING: This device contains batteries and
recyclable electronic components. To protect the
environment, do not dispose of it with household
waste. Dispose of used batteries at an appropriate
collection location following national or local
regulations.
CAUTION: Do not try to measure when the device is
wet, which may cause measurement results
inaccurate.
CAUTION: Before measurement, please make sure
that there is no sweat, cosmetics or oil stains on the
forehead of subject. Please make sure that the subject
does not take a bath, exercise or have a meal within 30
minutes, and the body is measured at a steady state.
CAUTION: During measurement, do not let the subject
directly face sunlight, heater or the air outlet of air
conditioner, which will change the temperature of the
forehead. Please conduct measurement in a stable
environment as far as possible.
CAUTION: When the product gets wet due to contact
with steam, do not use until it get dry or be gently wiped
with a soft, dry cloth or cotton balls, otherwise it will
cause measurement errors.
CAUTION: For patients measuring their own tempera-
ture, it is recommended to measure close to the
forehead.
CAUTION: Please read this instruction carefully before
use and confirm that the battery is installed.
CAUTION: Do not move while using.
CAUTION: Under the combined effects of the environ-
ment and the frequency of use, the product's housing
temperature may exceed 41℃. Please use it carefully.
CAUTION: Please pay attention to product storage to
prevent damage caused by pets, pests or children.
CAUTION: This product is a high-precision device,
please do not drop the device! Avoid drastic collisions
and jolts and other adverse possibilities for transport.
CAUTION: Due to the limited size of the label, the font is
too small, please put it in the appropriate position to
watch.
CAUTION: Do not store this thermometer in tempera-
ture extremes below -20℃(-4) or over +55℃(131
) or in excessive humidity (below 15% or above 90%
non-condensing relative humidity).
CAUTION: Do not use this thermometer in temperature
extremes below 10℃(50) or over 40℃(104) or in
excessive humidity (below 15% or above 90%
non-condensing relative humidity).
●Measurement environment:
Temperature: 10℃ (50
) to 40℃ (104)
Relative humidity: 15% to 90% (no condensation)
Atmospheric pressure: 70kPa to 106kPa
●Transportation and storage environment:
Temperature: -20℃(-4
) to +55℃ (131)
Relative humidity: 15% to 90%(no condensation)
Atmospheric pressure: 70kPa to 106kPa
When body temperature is 37.6 ℃(99.7) or higher,
the device will make sounds as "di-di-di" to prompt.
●Object temperature mode (Measure temperature
of object)
Short press the mode button in the power-on state,
and the display icon flashes to switch between body
temperature mode and object temperature mode.
After selecting " "(object temperature mode),
approach the object to be measured and press the
Power On/ Measure Button " " to display the
measurement result.
When the measured result is beyond device
measurement range Object temperature mode:
0.0℃~60.0℃(32.0~140.0), the thermometer will
make sounds as "di-di-di" to prompt, at the same
time, " " or " " appears on the display interface.
Notes: Please make sure the measurement method
and the external environment is normal at this time.
●Memory function : press memory button, memory
value inquiry can be carried out. Thermometer can
store 32 groups of memory values. When the
number of groups exceeds the specified number, the
latest memory value will cover the earliest memory
value.
●In memory mode, press and hold memory button,
when CLr is displayed on the screen, the memory
value is cleared.
●Sound switch setting
Step 1: In the shutdown state, long press the mode
button until the temperature unit flashes.
Step 2: Then short press memory button to switch to
sound setting.
Step 3: Press mode button to select sound on " "
or sound off " ".
Step 4: Press the Power On/ Measure Button " " to
confirm.
●Power off
In the absence of any operation, the device will
automatically shut down within 2 minutes.
6. Cleaning and Disinfection
Manual cleaning procedure
1. Use a clean and dry soft cloth or cotton swab to
gently wipe the sensor lens for a minimum of 30
seconds.
2. Thoroughly wipe the device surfaces with a
non-linting cloth dampened (not dripping) with soap
solution for at least three (3) minutes. And wipe the
device surface with a non-linting cloth dampened
(not dripping) with bottled water for at least three (3)
minutes.
NOTE: Prepare the cleaning solution according to the
detergent manufacturers instructions. (e.g.,
Alconox
® Powdered Precision Cleaner, 10 g/L)
NOTE: Pay extra attention to the device's cracks,
crevices, and hard-to-reach areas.
3. Dry the device thoroughly with a soft, clean,
non-linting cloth.
Post-cleaning inspection
Inspect the device visually after cleaning for
cleanliness, damage, and missing or illegible device
labeling or markings:
1.If any visible dirt or residue remains, repeat the
cleaning procedure.
2.Any damaged device should be removed from use.
Damage may include, but is not limited to, corrosion,
discoloration, excessive scratches, flaking, cracks,
and wear.
3. Remove any device with missing, illegible device
labeling or marking from use.
Disinfection procedure
1. Clean the device before disinfection.
2. With the probe facing down, wipe the device
surfaces with a non-linting cloth dampened (not
dripping) with 70% Isopropyl Alcohol (IPA).
3. Allow all surfaces to remain wet for at least two (2)
minutes. If necessary, use additional wipes to
ensure the surfaces remain wet for the full duration.
4. Dry thoroughly with a soft, clean, non-linting cloth.
5. Allow at least five (5) minutes of drying before
taking a temperature reading. Make sure the probe
lens is clean and dry before use.
7. Troubleshooting Instructions
Replace with
new batteries
The
screen
display
" "
The power of
batteries is shortage
The
screen
display
" "
Please contact
the dealer and
send it to the
factory for repair
Infrared sensor
sampling error
Please
remeasure
following the
product
instruction
Place the infrared
thermometer at
an ambient
temperature of 10℃
to 40℃ (50 to
104) and let it
stand for 30
minutes before
measuring. If the
problem persists,
please contact
the dealer and
send it to the
factory for repair
No display
The batteries are
not installed well
Low battery
Check if the
batteries are
installed upside
down
Replace with
new batteries
Please contact
the dealer and
send it to the
factory for repair
The screen is
still blank
9. Technical Specification
●Power source: DC 3V (2×1.5V AAA alkaline batteries)
●Measurement range in body temperature mode:
22.0℃~43.0℃(71.6~109.4)
●Display resolution: 0.1℃(0.1)
●Measurement accuracy:±0.2℃(±0.4) in the
range of 35.0℃~42.0℃(95.0~107.6); ±0.3℃
(±0.5) in the range of 22.0℃~34.9℃(71.6
94.8) and 42.1℃~43.0℃(107.8~109.4)
The positive and
negative poles of the
batteries are
reversed or the
device is abnormal
Reinstall the
batteries, or
contact the
dealer
5. Setup and Use
●Installing the battery
The device is supplied with
2 AAA alkaline batteries. Push
the battery cover downward and
load the battery into the battery
compartment. At this time, the
device will start self-inspection.
Pay attention to the positive and
negative poles instruction in the
battery compartment and snap
the battery cover back onto the
device. Refer to the picture at right:
●Setting measure unit
In the shutdown state, long press the mode button
until the unit symbol flashes, then short press the
mode button to select the temperature units " " and
" ", and press the Power On/ Measure Button" "
to confirm.
●Body temperature mode (Measure temperature of
human body)
1. Point the infrared thermometer probe at the center
of the eyebrows and keep a distance of 0-3 cm from
the forehead (non-contact).
2. Press the Power On/ Measure Button" ". After
about 1 second, the infrared thermometer will have a
prompt of sound and display the measurement results.
When the measured result is beyond device
measurement range Body temperature mode:
22.0℃~43.0℃(71.6~109.4); the thermometer
will make one quick continuous sounds as "di-di-di"
to prompt, at the same time, " " or " " appears on
the display interface, accompanied by an orange
backlight.
●According to ISO 80601-2-56, Rated output
range: 34.0℃ to 42.0℃(93.2 to 107.6). Rated
extended output range: 22.0℃ to 33.9℃ (71.6 to
93.0) and 42.1℃ to 43.0℃ (107.6 to 109.4)
●Electric shock protection: the device is supplied by
internal power
●Operation mode: continuous operation
●Temperature units: ℃/
●Body temperature mode measuring site: forehead
●Time interval of each measurement ≤1s.
●Measurement time: ≤1s.
●Degrees of protection provided by enclosures
(IP code): IP22
●Safety classification: the device that cannot be
used in the presence of flammable anesthetic gases
mixed with air or oxygen or nitrous oxide
●Product size: 6" ×1.5"×1.7"
(152mm×38mm×43mm)
●Product weight: About 0.15 lbs. (70g) (not
including battery)
●Number of memory groups: 32 groups
●Service life: 5 years
●The thermometer uses an adjusted mode when
measuring the body temperature.
●Battery replacement cycle: use the new battery for
no less than 3000 measurements
●Wireless connection: Bluetooth
●Frequency range: 2.400 GHz~2.4835 GHz
●Modulation mode: GFSK
●Transmitting power: ≤20dBm
●FCC ID: 2A2JJ-YHW-6
Recommended Range: ~10 feet (~3 meters)
line-of-sight
Quality of Service (QoS): Delay <10 seconds
This thermometer meets ASTM Standard E
1965-98 requirements. Full responsibility for the
conformance of this device to the standard is
assumed by JIANGSU YUYUE MEDICAL &
SUPPLY CO.,LTD..
ASTM laboratory accuracy requirements for
infrared thermometer in the display range of 37℃
39℃ (98 102) is ±0.2℃(±0.4), while for
mercury-in-glass and electronic thermometers, the
requirement, according to ASTM Standards
E667-86 and E1112-86 is ±0.1℃ (±0.2).
●The clinical validation was conducted according to
the requirements of ISO 80601-2-56. Take the
result measured by mercury thermometer from oral
cavity as the reference. Test three groups: 0 to 1
year old, older than 1 year and younger than 5
years, older than 5 years. The minimum number of
subjects in an age group shall be at least 35. The
test results are shown in the table below:
●Appendix:
Instructions, 2 AAA alkaline batteries
APP Quick Guide(for YHW-6).
●The thermometer uses an infrared sensor, which
can sense the ambient temperature and the infrared
heat radiation emitted by the human body.Referring
to the corresponding parameter table, the best core
algorithm is used to calculate the accurate tempera-
ture.
●Intended purpose: This device is used to measure
the forehead temperature of the human body. It is
intended for use on people of all ages except
pre-term babies or very small(small for gestational
age) babies.
●Indication: Intermittent measurement of human
body temperature from forehead, not for emergency
clinical condition.
●Intended users: Intended users: Health care
professional, or lay persons at least 11 years old.
●Clinical benefits: The device can be used to
measure body temperature so as to help to diagnose
body condition. The clinical benefit associated with
the device is defined as indirect, all intended patient
population can experience the benefit.
●Contraindication: None.
●The device is for professional use and consumer
use.
●Patient can take measurement by themselves, or
they can be taken by someone else using a
thermometer. Patients can perform all the mainte-
nance.
1. Device Use And Applicant Scope
3. Warnings and Precautions
4. Measurement And Transport Storage
Environment
CAUTION: To avoid dust entering the probe cavity
resulting in inaccurate measurements, install the
cover after each use.
CAUTION: Do not use non-specified detachable parts
and materials, otherwise the product may not work
properly.
CAUTION: This thermometer is not intended to
interpret hypothermic temperatures. If the device
displays a temperature of 36.4℃ (97.5 ) or less, and
the individual is exhibiting atypical symptoms or
behaviors, contact your physician or health care
professional.
CAUTION: Do not mix old and new batteries.
CAUTION: When using the thermometer with a smart
device, keep both devices within the recommended
range of each other (see Specifications for details);
moving outside of this range may cause a loss in
connection with the smart device.
CAUTION: When using the thermometer with a smart
device, keep the devices away from sources that may
interfere with the Bluetooth connection. Other devices
may cause radio frequency interference (RFI), which
may result in a loss of quality of service (see
Specifications for details) for the Bluetooth connection.
Devices that may cause RFI include but are not limited
to: electrocautery equipment, diathermy equipment,
other cellular telephones, wireless PC and tablets,
pagers, RFID devices, MRI, and electromagnetic
security systems.
CAUTION: The user is cautioned that changes or
modifications not expressly approved by the party
responsible for compliance could void the user's
authority to operate the equipment
NOTE: 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.
NOTE: This equipment has been tested and found to
comply with the limits for a Class B digital device,
according to Part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against
harmful interference in a residential installation. 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 encouraged to try to correct the
interference by one or more of the following measures:
●Reorient or relocate the receiving antenna.
The
screen
display
" "
The operating
environment
temperature has
changed
significantly
compared to the
storage
temperature.
Place the
thermometer at
the operating
environment
temperature for
30 minutes
before use.
Manufacturer mark
Symbols
Caution
Recyclable
Manufacturer
Implication
This way up
Fragile, handle with care
Keep dry
Date of manufacture
Serial number
Batch code
Medical device
Protection from ingress of particulates than
12.5mm. Dripping water falling within 15° of
vertical will not have a harmful effect on the
thermometer per IEC 60529
Temperature limit
Humidity limitation
Unique device identifier
Refer to instruction manual
Atmospheric pressure limitation
Catalogue number
UDI
Non-ionizing radiation
Safety and environmental protection use period
for 10 years
Symbol for the marking of electrical and electronic
devices according to Directive 2012/19/EU
10
Bluetooth
MR Unsafe. Not appropriate for use in MR
environment (i.e.: inside the MR magnet room)
●Increase the separation between the equipment and
receiver.
●Consult the dealer or an experienced radio/TV
technician for help.
8. Symbols
background
WARNING: The measurement result is only for
reference, which is not a substitute for a physician's
diagnosis. It is very dangerous to self-judge and treat
only based on the measurement result. Please follow
the doctor's instructions.
WARNING: Please put the battery out of the reach of
children, otherwise it is dangerous.
WARNING: When the product is not used for a long time
(more than 3 months), remove the battery from device
to prevent the battery leakage.
WARNING: If there is a temperature difference between
the environment of the storage and that of the
measurement, place the device in the measuring
environment for more than 30 minutes, otherwise
there may be errors in the measurement results.
WARNING: It is forbidden to immerse the infrared
thermometer in any liquid, and it is forbidden to use it
for a long time under too high or low temperature
condition. No collisions, drops and mixing with sharp
objects.
WARNING: Do not put the battery close to the fire or into
the fire to avoid the battery explosion. Do not use the
battery when it leaks or molds. When discarding
batteries or this product, follow local regulations to
avoid contamination.
WARNING: This device contains sensitive electronic
components and should not be used in environments
with strong electromagnetic interference (e.g., mobile
phones, microwave ovens, etc.) to prevent temporary
impacts on its accuracy.
WARNING: Do not modify the device without authoriza-
tion from the manufacturer. If the device is damaged,
return the device to the manufacturer or distributor for
service.
WARNING: If the situations cannot be solved or
unexpected problem happens, please consult the local
01 03 0402
2. Device Structure and Composition
05 06 07
●Device main structure and composition
The thermometer consists of a housing, a sensor, a
display and a circuit board.
Detachable parts and materials for use: cover, 2
AAA alkaline batteries
Battery
Reminder
Temperature Unit
Sound Prompt
Body Temperature
Mode
Result Display
Object Temperature
Mode
Memory Mark
Phenomenon
of breakdown
The operating
environment
temperature is lower
than 10℃ (50.0)
When in body
temperature mode,
the measurement
result is >43.0℃
(109.4) or when in
the object
temperature mode,
the measurement
result is >60.0℃
(140.0)
The
screen
display
" "
The
screen
display
" "
Possible cause
Trouble shooting
methods
In the body
temperature mode,
the measurement
result is<22.0℃
(71.6) or in the
object temperature
mode, the
measurement result
is <0.0℃ (32.0)
The
screen
display
" "
The
screen
display
" "
The operating
environment
temperature is higher
than 40℃(104.0)
08 09
10
Power On/
Measure Button
LCD Display
Area
Temperature
Probe
Battery
Cover
Mode
Button
Memory
Button
MODE MEMO
distributor.
WARNING: Do not immerse this device in medical
alcohol or other liquids.
WARNING: Avoid contact between liquid and the
devices metal parts.
WARNING: Dispose of thermometer, accessories, and
battery per local laws and regulations.
WARNING: This device contains batteries and
recyclable electronic components. To protect the
environment, do not dispose of it with household
waste. Dispose of used batteries at an appropriate
collection location following national or local
regulations.
CAUTION: Do not try to measure when the device is
wet, which may cause measurement results
inaccurate.
CAUTION: Before measurement, please make sure
that there is no sweat, cosmetics or oil stains on the
forehead of subject. Please make sure that the subject
does not take a bath, exercise or have a meal within 30
minutes, and the body is measured at a steady state.
CAUTION: During measurement, do not let the subject
directly face sunlight, heater or the air outlet of air
conditioner, which will change the temperature of the
forehead. Please conduct measurement in a stable
environment as far as possible.
CAUTION: When the product gets wet due to contact
with steam, do not use until it get dry or be gently wiped
with a soft, dry cloth or cotton balls, otherwise it will
cause measurement errors.
CAUTION: For patients measuring their own tempera-
ture, it is recommended to measure close to the
forehead.
CAUTION: Please read this instruction carefully before
use and confirm that the battery is installed.
CAUTION: Do not move while using.
CAUTION: Under the combined effects of the environ-
ment and the frequency of use, the product's housing
temperature may exceed 41℃. Please use it carefully.
CAUTION: Please pay attention to product storage to
prevent damage caused by pets, pests or children.
CAUTION: This product is a high-precision device,
please do not drop the device! Avoid drastic collisions
and jolts and other adverse possibilities for transport.
CAUTION: Due to the limited size of the label, the font is
too small, please put it in the appropriate position to
watch.
CAUTION: Do not store this thermometer in tempera-
ture extremes below -20℃(-4) or over +55℃(131
) or in excessive humidity (below 15% or above 90%
non-condensing relative humidity).
CAUTION: Do not use this thermometer in temperature
extremes below 10℃(50) or over 40℃(104) or in
excessive humidity (below 15% or above 90%
non-condensing relative humidity).
●Measurement environment:
Temperature: 10℃ (50
) to 40℃ (104)
Relative humidity: 15% to 90% (no condensation)
Atmospheric pressure: 70kPa to 106kPa
●Transportation and storage environment:
Temperature: -20℃(-4
) to +55℃ (131)
Relative humidity: 15% to 90%(no condensation)
Atmospheric pressure: 70kPa to 106kPa
When body temperature is 37.6 ℃(99.7) or higher,
the device will make sounds as "di-di-di" to prompt.
●Object temperature mode (Measure temperature
of object)
Short press the mode button in the power-on state,
and the display icon flashes to switch between body
temperature mode and object temperature mode.
After selecting " "(object temperature mode),
approach the object to be measured and press the
Power On/ Measure Button " " to display the
measurement result.
When the measured result is beyond device
measurement range Object temperature mode:
0.0℃~60.0℃(32.0~140.0), the thermometer will
make sounds as "di-di-di" to prompt, at the same
time, " " or " " appears on the display interface.
Notes: Please make sure the measurement method
and the external environment is normal at this time.
●Memory function : press memory button, memory
value inquiry can be carried out. Thermometer can
store 32 groups of memory values. When the
number of groups exceeds the specified number, the
latest memory value will cover the earliest memory
value.
●In memory mode, press and hold memory button,
when CLr is displayed on the screen, the memory
value is cleared.
●Sound switch setting
Step 1: In the shutdown state, long press the mode
button until the temperature unit flashes.
Step 2: Then short press memory button to switch to
sound setting.
Step 3: Press mode button to select sound on " "
or sound off " ".
Step 4: Press the Power On/ Measure Button " " to
confirm.
●Power off
In the absence of any operation, the device will
automatically shut down within 2 minutes.
6. Cleaning and Disinfection
Manual cleaning procedure
1. Use a clean and dry soft cloth or cotton swab to
gently wipe the sensor lens for a minimum of 30
seconds.
2. Thoroughly wipe the device surfaces with a
non-linting cloth dampened (not dripping) with soap
solution for at least three (3) minutes. And wipe the
device surface with a non-linting cloth dampened
(not dripping) with bottled water for at least three (3)
minutes.
NOTE: Prepare the cleaning solution according to the
detergent manufacturers instructions. (e.g.,
Alconox
® Powdered Precision Cleaner, 10 g/L)
NOTE: Pay extra attention to the device's cracks,
crevices, and hard-to-reach areas.
3. Dry the device thoroughly with a soft, clean,
non-linting cloth.
Post-cleaning inspection
Inspect the device visually after cleaning for
cleanliness, damage, and missing or illegible device
labeling or markings:
1.If any visible dirt or residue remains, repeat the
cleaning procedure.
2.Any damaged device should be removed from use.
Damage may include, but is not limited to, corrosion,
discoloration, excessive scratches, flaking, cracks,
and wear.
3. Remove any device with missing, illegible device
labeling or marking from use.
Disinfection procedure
1. Clean the device before disinfection.
2. With the probe facing down, wipe the device
surfaces with a non-linting cloth dampened (not
dripping) with 70% Isopropyl Alcohol (IPA).
3. Allow all surfaces to remain wet for at least two (2)
minutes. If necessary, use additional wipes to
ensure the surfaces remain wet for the full duration.
4. Dry thoroughly with a soft, clean, non-linting cloth.
5. Allow at least five (5) minutes of drying before
taking a temperature reading. Make sure the probe
lens is clean and dry before use.
7. Troubleshooting Instructions
Replace with
new batteries
The
screen
display
" "
The power of
batteries is shortage
The
screen
display
" "
Please contact
the dealer and
send it to the
factory for repair
Infrared sensor
sampling error
Please
remeasure
following the
product
instruction
Place the infrared
thermometer at
an ambient
temperature of 10℃
to 40℃ (50 to
104) and let it
stand for 30
minutes before
measuring. If the
problem persists,
please contact
the dealer and
send it to the
factory for repair
No display
The batteries are
not installed well
Low battery
Check if the
batteries are
installed upside
down
Replace with
new batteries
Please contact
the dealer and
send it to the
factory for repair
The screen is
still blank
9. Technical Specification
●Power source: DC 3V (2×1.5V AAA alkaline batteries)
●Measurement range in body temperature mode:
22.0℃~43.0℃(71.6~109.4)
●Display resolution: 0.1℃(0.1)
●Measurement accuracy:±0.2℃(±0.4) in the
range of 35.0℃~42.0℃(95.0~107.6); ±0.3℃
(±0.5) in the range of 22.0℃~34.9℃(71.6
94.8) and 42.1℃~43.0℃(107.8~109.4)
The positive and
negative poles of the
batteries are
reversed or the
device is abnormal
Reinstall the
batteries, or
contact the
dealer
5. Setup and Use
●Installing the battery
The device is supplied with
2 AAA alkaline batteries. Push
the battery cover downward and
load the battery into the battery
compartment. At this time, the
device will start self-inspection.
Pay attention to the positive and
negative poles instruction in the
battery compartment and snap
the battery cover back onto the
device. Refer to the picture at right:
●Setting measure unit
In the shutdown state, long press the mode button
until the unit symbol flashes, then short press the
mode button to select the temperature units " " and
" ", and press the Power On/ Measure Button" "
to confirm.
●Body temperature mode (Measure temperature of
human body)
1. Point the infrared thermometer probe at the center
of the eyebrows and keep a distance of 0-3 cm from
the forehead (non-contact).
2. Press the Power On/ Measure Button" ". After
about 1 second, the infrared thermometer will have a
prompt of sound and display the measurement results.
When the measured result is beyond device
measurement range Body temperature mode:
22.0℃~43.0℃(71.6~109.4); the thermometer
will make one quick continuous sounds as "di-di-di"
to prompt, at the same time, " " or " " appears on
the display interface, accompanied by an orange
backlight.
●According to ISO 80601-2-56, Rated output
range: 34.0℃ to 42.0℃(93.2 to 107.6). Rated
extended output range: 22.0℃ to 33.9℃ (71.6 to
93.0) and 42.1℃ to 43.0℃ (107.6 to 109.4)
●Electric shock protection: the device is supplied by
internal power
●Operation mode: continuous operation
●Temperature units: ℃/
●Body temperature mode measuring site: forehead
●Time interval of each measurement ≤1s.
●Measurement time: ≤1s.
●Degrees of protection provided by enclosures
(IP code): IP22
●Safety classification: the device that cannot be
used in the presence of flammable anesthetic gases
mixed with air or oxygen or nitrous oxide
●Product size: 6" ×1.5"×1.7"
(152mm×38mm×43mm)
●Product weight: About 0.15 lbs. (70g) (not
including battery)
●Number of memory groups: 32 groups
●Service life: 5 years
●The thermometer uses an adjusted mode when
measuring the body temperature.
●Battery replacement cycle: use the new battery for
no less than 3000 measurements
●Wireless connection: Bluetooth
●Frequency range: 2.400 GHz~2.4835 GHz
●Modulation mode: GFSK
●Transmitting power: ≤20dBm
●FCC ID: 2A2JJ-YHW-6
Recommended Range: ~10 feet (~3 meters)
line-of-sight
Quality of Service (QoS): Delay <10 seconds
This thermometer meets ASTM Standard E
1965-98 requirements. Full responsibility for the
conformance of this device to the standard is
assumed by JIANGSU YUYUE MEDICAL &
SUPPLY CO.,LTD..
ASTM laboratory accuracy requirements for
infrared thermometer in the display range of 37℃
39℃ (98 102) is ±0.2℃(±0.4), while for
mercury-in-glass and electronic thermometers, the
requirement, according to ASTM Standards
E667-86 and E1112-86 is ±0.1℃ (±0.2).
●The clinical validation was conducted according to
the requirements of ISO 80601-2-56. Take the
result measured by mercury thermometer from oral
cavity as the reference. Test three groups: 0 to 1
year old, older than 1 year and younger than 5
years, older than 5 years. The minimum number of
subjects in an age group shall be at least 35. The
test results are shown in the table below:
●Appendix:
Instructions, 2 AAA alkaline batteries
APP Quick Guide(for YHW-6).
●The thermometer uses an infrared sensor, which
can sense the ambient temperature and the infrared
heat radiation emitted by the human body.Referring
to the corresponding parameter table, the best core
algorithm is used to calculate the accurate tempera-
ture.
●Intended purpose: This device is used to measure
the forehead temperature of the human body. It is
intended for use on people of all ages except
pre-term babies or very small(small for gestational
age) babies.
●Indication: Intermittent measurement of human
body temperature from forehead, not for emergency
clinical condition.
●Intended users: Intended users: Health care
professional, or lay persons at least 11 years old.
●Clinical benefits: The device can be used to
measure body temperature so as to help to diagnose
body condition. The clinical benefit associated with
the device is defined as indirect, all intended patient
population can experience the benefit.
●Contraindication: None.
●The device is for professional use and consumer
use.
●Patient can take measurement by themselves, or
they can be taken by someone else using a
thermometer. Patients can perform all the mainte-
nance.
1. Device Use And Applicant Scope
3. Warnings and Precautions
4. Measurement And Transport Storage
Environment
CAUTION: To avoid dust entering the probe cavity
resulting in inaccurate measurements, install the
cover after each use.
CAUTION: Do not use non-specified detachable parts
and materials, otherwise the product may not work
properly.
CAUTION: This thermometer is not intended to
interpret hypothermic temperatures. If the device
displays a temperature of 36.4℃ (97.5 ) or less, and
the individual is exhibiting atypical symptoms or
behaviors, contact your physician or health care
professional.
CAUTION: Do not mix old and new batteries.
CAUTION: When using the thermometer with a smart
device, keep both devices within the recommended
range of each other (see Specifications for details);
moving outside of this range may cause a loss in
connection with the smart device.
CAUTION: When using the thermometer with a smart
device, keep the devices away from sources that may
interfere with the Bluetooth connection. Other devices
may cause radio frequency interference (RFI), which
may result in a loss of quality of service (see
Specifications for details) for the Bluetooth connection.
Devices that may cause RFI include but are not limited
to: electrocautery equipment, diathermy equipment,
other cellular telephones, wireless PC and tablets,
pagers, RFID devices, MRI, and electromagnetic
security systems.
CAUTION: The user is cautioned that changes or
modifications not expressly approved by the party
responsible for compliance could void the user's
authority to operate the equipment
NOTE: 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.
NOTE: This equipment has been tested and found to
comply with the limits for a Class B digital device,
according to Part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against
harmful interference in a residential installation. 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 encouraged to try to correct the
interference by one or more of the following measures:
●Reorient or relocate the receiving antenna.
The
screen
display
" "
The operating
environment
temperature has
changed
significantly
compared to the
storage
temperature.
Place the
thermometer at
the operating
environment
temperature for
30 minutes
before use.
Manufacturer mark
Symbols
Caution
Recyclable
Manufacturer
Implication
This way up
Fragile, handle with care
Keep dry
Date of manufacture
Serial number
Batch code
Medical device
Protection from ingress of particulates than
12.5mm. Dripping water falling within 15° of
vertical will not have a harmful effect on the
thermometer per IEC 60529
Temperature limit
Humidity limitation
Unique device identifier
Refer to instruction manual
Atmospheric pressure limitation
Catalogue number
UDI
Non-ionizing radiation
Safety and environmental protection use period
for 10 years
Symbol for the marking of electrical and electronic
devices according to Directive 2012/19/EU
10
Bluetooth
MR Unsafe. Not appropriate for use in MR
environment (i.e.: inside the MR magnet room)
●Increase the separation between the equipment and
receiver.
●Consult the dealer or an experienced radio/TV
technician for help.
8. Symbols
background
WARNING: The measurement result is only for
reference, which is not a substitute for a physician's
diagnosis. It is very dangerous to self-judge and treat
only based on the measurement result. Please follow
the doctor's instructions.
WARNING: Please put the battery out of the reach of
children, otherwise it is dangerous.
WARNING: When the product is not used for a long time
(more than 3 months), remove the battery from device
to prevent the battery leakage.
WARNING: If there is a temperature difference between
the environment of the storage and that of the
measurement, place the device in the measuring
environment for more than 30 minutes, otherwise
there may be errors in the measurement results.
WARNING: It is forbidden to immerse the infrared
thermometer in any liquid, and it is forbidden to use it
for a long time under too high or low temperature
condition. No collisions, drops and mixing with sharp
objects.
WARNING: Do not put the battery close to the fire or into
the fire to avoid the battery explosion. Do not use the
battery when it leaks or molds. When discarding
batteries or this product, follow local regulations to
avoid contamination.
WARNING: This device contains sensitive electronic
components and should not be used in environments
with strong electromagnetic interference (e.g., mobile
phones, microwave ovens, etc.) to prevent temporary
impacts on its accuracy.
WARNING: Do not modify the device without authoriza-
tion from the manufacturer. If the device is damaged,
return the device to the manufacturer or distributor for
service.
WARNING: If the situations cannot be solved or
unexpected problem happens, please consult the local
01 03 0402
2. Device Structure and Composition
05 06 07
●Device main structure and composition
The thermometer consists of a housing, a sensor, a
display and a circuit board.
Detachable parts and materials for use: cover, 2
AAA alkaline batteries
Battery
Reminder
Temperature Unit
Sound Prompt
Body Temperature
Mode
Result Display
Object Temperature
Mode
Memory Mark
Phenomenon
of breakdown
The operating
environment
temperature is lower
than 10℃ (50.0)
When in body
temperature mode,
the measurement
result is >43.0℃
(109.4) or when in
the object
temperature mode,
the measurement
result is >60.0℃
(140.0)
The
screen
display
" "
The
screen
display
" "
Possible cause
Trouble shooting
methods
In the body
temperature mode,
the measurement
result is<22.0℃
(71.6) or in the
object temperature
mode, the
measurement result
is <0.0℃ (32.0)
The
screen
display
" "
The
screen
display
" "
The operating
environment
temperature is higher
than 40℃(104.0)
08 09
10
Power On/
Measure Button
LCD Display
Area
Temperature
Probe
Battery
Cover
Mode
Button
Memory
Button
MODE MEMO
distributor.
WARNING: Do not immerse this device in medical
alcohol or other liquids.
WARNING: Avoid contact between liquid and the
devices metal parts.
WARNING: Dispose of thermometer, accessories, and
battery per local laws and regulations.
WARNING: This device contains batteries and
recyclable electronic components. To protect the
environment, do not dispose of it with household
waste. Dispose of used batteries at an appropriate
collection location following national or local
regulations.
CAUTION: Do not try to measure when the device is
wet, which may cause measurement results
inaccurate.
CAUTION: Before measurement, please make sure
that there is no sweat, cosmetics or oil stains on the
forehead of subject. Please make sure that the subject
does not take a bath, exercise or have a meal within 30
minutes, and the body is measured at a steady state.
CAUTION: During measurement, do not let the subject
directly face sunlight, heater or the air outlet of air
conditioner, which will change the temperature of the
forehead. Please conduct measurement in a stable
environment as far as possible.
CAUTION: When the product gets wet due to contact
with steam, do not use until it get dry or be gently wiped
with a soft, dry cloth or cotton balls, otherwise it will
cause measurement errors.
CAUTION: For patients measuring their own tempera-
ture, it is recommended to measure close to the
forehead.
CAUTION: Please read this instruction carefully before
use and confirm that the battery is installed.
CAUTION: Do not move while using.
CAUTION: Under the combined effects of the environ-
ment and the frequency of use, the product's housing
temperature may exceed 41℃. Please use it carefully.
CAUTION: Please pay attention to product storage to
prevent damage caused by pets, pests or children.
CAUTION: This product is a high-precision device,
please do not drop the device! Avoid drastic collisions
and jolts and other adverse possibilities for transport.
CAUTION: Due to the limited size of the label, the font is
too small, please put it in the appropriate position to
watch.
CAUTION: Do not store this thermometer in tempera-
ture extremes below -20℃(-4) or over +55℃(131
) or in excessive humidity (below 15% or above 90%
non-condensing relative humidity).
CAUTION: Do not use this thermometer in temperature
extremes below 10℃(50) or over 40℃(104) or in
excessive humidity (below 15% or above 90%
non-condensing relative humidity).
●Measurement environment:
Temperature: 10℃ (50
) to 40℃ (104)
Relative humidity: 15% to 90% (no condensation)
Atmospheric pressure: 70kPa to 106kPa
●Transportation and storage environment:
Temperature: -20℃(-4
) to +55℃ (131)
Relative humidity: 15% to 90%(no condensation)
Atmospheric pressure: 70kPa to 106kPa
When body temperature is 37.6 ℃(99.7) or higher,
the device will make sounds as "di-di-di" to prompt.
●Object temperature mode (Measure temperature
of object)
Short press the mode button in the power-on state,
and the display icon flashes to switch between body
temperature mode and object temperature mode.
After selecting " "(object temperature mode),
approach the object to be measured and press the
Power On/ Measure Button " " to display the
measurement result.
When the measured result is beyond device
measurement range Object temperature mode:
0.0℃~60.0℃(32.0~140.0), the thermometer will
make sounds as "di-di-di" to prompt, at the same
time, " " or " " appears on the display interface.
Notes: Please make sure the measurement method
and the external environment is normal at this time.
●Memory function : press memory button, memory
value inquiry can be carried out. Thermometer can
store 32 groups of memory values. When the
number of groups exceeds the specified number, the
latest memory value will cover the earliest memory
value.
●In memory mode, press and hold memory button,
when CLr is displayed on the screen, the memory
value is cleared.
●Sound switch setting
Step 1: In the shutdown state, long press the mode
button until the temperature unit flashes.
Step 2: Then short press memory button to switch to
sound setting.
Step 3: Press mode button to select sound on " "
or sound off " ".
Step 4: Press the Power On/ Measure Button " " to
confirm.
●Power off
In the absence of any operation, the device will
automatically shut down within 2 minutes.
6. Cleaning and Disinfection
Manual cleaning procedure
1. Use a clean and dry soft cloth or cotton swab to
gently wipe the sensor lens for a minimum of 30
seconds.
2. Thoroughly wipe the device surfaces with a
non-linting cloth dampened (not dripping) with soap
solution for at least three (3) minutes. And wipe the
device surface with a non-linting cloth dampened
(not dripping) with bottled water for at least three (3)
minutes.
NOTE: Prepare the cleaning solution according to the
detergent manufacturers instructions. (e.g.,
Alconox
® Powdered Precision Cleaner, 10 g/L)
NOTE: Pay extra attention to the device's cracks,
crevices, and hard-to-reach areas.
3. Dry the device thoroughly with a soft, clean,
non-linting cloth.
Post-cleaning inspection
Inspect the device visually after cleaning for
cleanliness, damage, and missing or illegible device
labeling or markings:
1.If any visible dirt or residue remains, repeat the
cleaning procedure.
2.Any damaged device should be removed from use.
Damage may include, but is not limited to, corrosion,
discoloration, excessive scratches, flaking, cracks,
and wear.
3. Remove any device with missing, illegible device
labeling or marking from use.
Disinfection procedure
1. Clean the device before disinfection.
2. With the probe facing down, wipe the device
surfaces with a non-linting cloth dampened (not
dripping) with 70% Isopropyl Alcohol (IPA).
3. Allow all surfaces to remain wet for at least two (2)
minutes. If necessary, use additional wipes to
ensure the surfaces remain wet for the full duration.
4. Dry thoroughly with a soft, clean, non-linting cloth.
5. Allow at least five (5) minutes of drying before
taking a temperature reading. Make sure the probe
lens is clean and dry before use.
7. Troubleshooting Instructions
Replace with
new batteries
The
screen
display
" "
The power of
batteries is shortage
The
screen
display
" "
Please contact
the dealer and
send it to the
factory for repair
Infrared sensor
sampling error
Please
remeasure
following the
product
instruction
Place the infrared
thermometer at
an ambient
temperature of 10℃
to 40℃ (50 to
104) and let it
stand for 30
minutes before
measuring. If the
problem persists,
please contact
the dealer and
send it to the
factory for repair
No display
The batteries are
not installed well
Low battery
Check if the
batteries are
installed upside
down
Replace with
new batteries
Please contact
the dealer and
send it to the
factory for repair
The screen is
still blank
9. Technical Specification
●Power source: DC 3V (2×1.5V AAA alkaline batteries)
●Measurement range in body temperature mode:
22.0℃~43.0℃(71.6~109.4)
●Display resolution: 0.1℃(0.1)
●Measurement accuracy:±0.2℃(±0.4) in the
range of 35.0℃~42.0℃(95.0~107.6); ±0.3℃
(±0.5) in the range of 22.0℃~34.9℃(71.6
94.8) and 42.1℃~43.0℃(107.8~109.4)
The positive and
negative poles of the
batteries are
reversed or the
device is abnormal
Reinstall the
batteries, or
contact the
dealer
5. Setup and Use
●Installing the battery
The device is supplied with
2 AAA alkaline batteries. Push
the battery cover downward and
load the battery into the battery
compartment. At this time, the
device will start self-inspection.
Pay attention to the positive and
negative poles instruction in the
battery compartment and snap
the battery cover back onto the
device. Refer to the picture at right:
●Setting measure unit
In the shutdown state, long press the mode button
until the unit symbol flashes, then short press the
mode button to select the temperature units " " and
" ", and press the Power On/ Measure Button" "
to confirm.
●Body temperature mode (Measure temperature of
human body)
1. Point the infrared thermometer probe at the center
of the eyebrows and keep a distance of 0-3 cm from
the forehead (non-contact).
2. Press the Power On/ Measure Button" ". After
about 1 second, the infrared thermometer will have a
prompt of sound and display the measurement results.
When the measured result is beyond device
measurement range Body temperature mode:
22.0℃~43.0℃(71.6~109.4); the thermometer
will make one quick continuous sounds as "di-di-di"
to prompt, at the same time, " " or " " appears on
the display interface, accompanied by an orange
backlight.
●According to ISO 80601-2-56, Rated output
range: 34.0℃ to 42.0℃(93.2 to 107.6). Rated
extended output range: 22.0℃ to 33.9℃ (71.6 to
93.0) and 42.1℃ to 43.0℃ (107.6 to 109.4)
●Electric shock protection: the device is supplied by
internal power
●Operation mode: continuous operation
●Temperature units: ℃/
●Body temperature mode measuring site: forehead
●Time interval of each measurement ≤1s.
●Measurement time: ≤1s.
●Degrees of protection provided by enclosures
(IP code): IP22
●Safety classification: the device that cannot be
used in the presence of flammable anesthetic gases
mixed with air or oxygen or nitrous oxide
●Product size: 6" ×1.5"×1.7"
(152mm×38mm×43mm)
●Product weight: About 0.15 lbs. (70g) (not
including battery)
●Number of memory groups: 32 groups
●Service life: 5 years
●The thermometer uses an adjusted mode when
measuring the body temperature.
●Battery replacement cycle: use the new battery for
no less than 3000 measurements
●Wireless connection: Bluetooth
●Frequency range: 2.400 GHz~2.4835 GHz
●Modulation mode: GFSK
●Transmitting power: ≤20dBm
●FCC ID: 2A2JJ-YHW-6
Recommended Range: ~10 feet (~3 meters)
line-of-sight
Quality of Service (QoS): Delay <10 seconds
This thermometer meets ASTM Standard E
1965-98 requirements. Full responsibility for the
conformance of this device to the standard is
assumed by JIANGSU YUYUE MEDICAL &
SUPPLY CO.,LTD..
ASTM laboratory accuracy requirements for
infrared thermometer in the display range of 37℃
39℃ (98 102) is ±0.2℃(±0.4), while for
mercury-in-glass and electronic thermometers, the
requirement, according to ASTM Standards
E667-86 and E1112-86 is ±0.1℃ (±0.2).
●The clinical validation was conducted according to
the requirements of ISO 80601-2-56. Take the
result measured by mercury thermometer from oral
cavity as the reference. Test three groups: 0 to 1
year old, older than 1 year and younger than 5
years, older than 5 years. The minimum number of
subjects in an age group shall be at least 35. The
test results are shown in the table below:
●Appendix:
Instructions, 2 AAA alkaline batteries
APP Quick Guide(for YHW-6).
●The thermometer uses an infrared sensor, which
can sense the ambient temperature and the infrared
heat radiation emitted by the human body.Referring
to the corresponding parameter table, the best core
algorithm is used to calculate the accurate tempera-
ture.
●Intended purpose: This device is used to measure
the forehead temperature of the human body. It is
intended for use on people of all ages except
pre-term babies or very small(small for gestational
age) babies.
●Indication: Intermittent measurement of human
body temperature from forehead, not for emergency
clinical condition.
●Intended users: Intended users: Health care
professional, or lay persons at least 11 years old.
●Clinical benefits: The device can be used to
measure body temperature so as to help to diagnose
body condition. The clinical benefit associated with
the device is defined as indirect, all intended patient
population can experience the benefit.
●Contraindication: None.
●The device is for professional use and consumer
use.
●Patient can take measurement by themselves, or
they can be taken by someone else using a
thermometer. Patients can perform all the mainte-
nance.
1. Device Use And Applicant Scope
3. Warnings and Precautions
4. Measurement And Transport Storage
Environment
CAUTION: To avoid dust entering the probe cavity
resulting in inaccurate measurements, install the
cover after each use.
CAUTION: Do not use non-specified detachable parts
and materials, otherwise the product may not work
properly.
CAUTION: This thermometer is not intended to
interpret hypothermic temperatures. If the device
displays a temperature of 36.4℃ (97.5 ) or less, and
the individual is exhibiting atypical symptoms or
behaviors, contact your physician or health care
professional.
CAUTION: Do not mix old and new batteries.
CAUTION: When using the thermometer with a smart
device, keep both devices within the recommended
range of each other (see Specifications for details);
moving outside of this range may cause a loss in
connection with the smart device.
CAUTION: When using the thermometer with a smart
device, keep the devices away from sources that may
interfere with the Bluetooth connection. Other devices
may cause radio frequency interference (RFI), which
may result in a loss of quality of service (see
Specifications for details) for the Bluetooth connection.
Devices that may cause RFI include but are not limited
to: electrocautery equipment, diathermy equipment,
other cellular telephones, wireless PC and tablets,
pagers, RFID devices, MRI, and electromagnetic
security systems.
CAUTION: The user is cautioned that changes or
modifications not expressly approved by the party
responsible for compliance could void the user's
authority to operate the equipment
NOTE: 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.
NOTE: This equipment has been tested and found to
comply with the limits for a Class B digital device,
according to Part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against
harmful interference in a residential installation. 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 encouraged to try to correct the
interference by one or more of the following measures:
●Reorient or relocate the receiving antenna.
The
screen
display
" "
The operating
environment
temperature has
changed
significantly
compared to the
storage
temperature.
Place the
thermometer at
the operating
environment
temperature for
30 minutes
before use.
Manufacturer mark
Symbols
Caution
Recyclable
Manufacturer
Implication
This way up
Fragile, handle with care
Keep dry
Date of manufacture
Serial number
Batch code
Medical device
Protection from ingress of particulates than
12.5mm. Dripping water falling within 15° of
vertical will not have a harmful effect on the
thermometer per IEC 60529
Temperature limit
Humidity limitation
Unique device identifier
Refer to instruction manual
Atmospheric pressure limitation
Catalogue number
UDI
Non-ionizing radiation
Safety and environmental protection use period
for 10 years
Symbol for the marking of electrical and electronic
devices according to Directive 2012/19/EU
10
Bluetooth
MR Unsafe. Not appropriate for use in MR
environment (i.e.: inside the MR magnet room)
●Increase the separation between the equipment and
receiver.
●Consult the dealer or an experienced radio/TV
technician for help.
8. Symbols
background
WARNING: The measurement result is only for
reference, which is not a substitute for a physician's
diagnosis. It is very dangerous to self-judge and treat
only based on the measurement result. Please follow
the doctor's instructions.
WARNING: Please put the battery out of the reach of
children, otherwise it is dangerous.
WARNING: When the product is not used for a long time
(more than 3 months), remove the battery from device
to prevent the battery leakage.
WARNING: If there is a temperature difference between
the environment of the storage and that of the
measurement, place the device in the measuring
environment for more than 30 minutes, otherwise
there may be errors in the measurement results.
WARNING: It is forbidden to immerse the infrared
thermometer in any liquid, and it is forbidden to use it
for a long time under too high or low temperature
condition. No collisions, drops and mixing with sharp
objects.
WARNING: Do not put the battery close to the fire or into
the fire to avoid the battery explosion. Do not use the
battery when it leaks or molds. When discarding
batteries or this product, follow local regulations to
avoid contamination.
WARNING: This device contains sensitive electronic
components and should not be used in environments
with strong electromagnetic interference (e.g., mobile
phones, microwave ovens, etc.) to prevent temporary
impacts on its accuracy.
WARNING: Do not modify the device without authoriza-
tion from the manufacturer. If the device is damaged,
return the device to the manufacturer or distributor for
service.
WARNING: If the situations cannot be solved or
unexpected problem happens, please consult the local
01 03 0402
2. Device Structure and Composition
05 06 07
●Device main structure and composition
The thermometer consists of a housing, a sensor, a
display and a circuit board.
Detachable parts and materials for use: cover, 2
AAA alkaline batteries
Battery
Reminder
Temperature Unit
Sound Prompt
Body Temperature
Mode
Result Display
Object Temperature
Mode
Memory Mark
Phenomenon
of breakdown
The operating
environment
temperature is lower
than 10℃ (50.0)
When in body
temperature mode,
the measurement
result is >43.0℃
(109.4) or when in
the object
temperature mode,
the measurement
result is >60.0℃
(140.0)
The
screen
display
" "
The
screen
display
" "
Possible cause
Trouble shooting
methods
In the body
temperature mode,
the measurement
result is<22.0℃
(71.6) or in the
object temperature
mode, the
measurement result
is <0.0℃ (32.0)
The
screen
display
" "
The
screen
display
" "
The operating
environment
temperature is higher
than 40℃(104.0)
08 09
10
Power On/
Measure Button
LCD Display
Area
Temperature
Probe
Battery
Cover
Mode
Button
Memory
Button
MODE MEMO
distributor.
WARNING: Do not immerse this device in medical
alcohol or other liquids.
WARNING: Avoid contact between liquid and the
devices metal parts.
WARNING: Dispose of thermometer, accessories, and
battery per local laws and regulations.
WARNING: This device contains batteries and
recyclable electronic components. To protect the
environment, do not dispose of it with household
waste. Dispose of used batteries at an appropriate
collection location following national or local
regulations.
CAUTION: Do not try to measure when the device is
wet, which may cause measurement results
inaccurate.
CAUTION: Before measurement, please make sure
that there is no sweat, cosmetics or oil stains on the
forehead of subject. Please make sure that the subject
does not take a bath, exercise or have a meal within 30
minutes, and the body is measured at a steady state.
CAUTION: During measurement, do not let the subject
directly face sunlight, heater or the air outlet of air
conditioner, which will change the temperature of the
forehead. Please conduct measurement in a stable
environment as far as possible.
CAUTION: When the product gets wet due to contact
with steam, do not use until it get dry or be gently wiped
with a soft, dry cloth or cotton balls, otherwise it will
cause measurement errors.
CAUTION: For patients measuring their own tempera-
ture, it is recommended to measure close to the
forehead.
CAUTION: Please read this instruction carefully before
use and confirm that the battery is installed.
CAUTION: Do not move while using.
CAUTION: Under the combined effects of the environ-
ment and the frequency of use, the product's housing
temperature may exceed 41℃. Please use it carefully.
CAUTION: Please pay attention to product storage to
prevent damage caused by pets, pests or children.
CAUTION: This product is a high-precision device,
please do not drop the device! Avoid drastic collisions
and jolts and other adverse possibilities for transport.
CAUTION: Due to the limited size of the label, the font is
too small, please put it in the appropriate position to
watch.
CAUTION: Do not store this thermometer in tempera-
ture extremes below -20℃(-4) or over +55℃(131
) or in excessive humidity (below 15% or above 90%
non-condensing relative humidity).
CAUTION: Do not use this thermometer in temperature
extremes below 10℃(50) or over 40℃(104) or in
excessive humidity (below 15% or above 90%
non-condensing relative humidity).
●Measurement environment:
Temperature: 10℃ (50
) to 40℃ (104)
Relative humidity: 15% to 90% (no condensation)
Atmospheric pressure: 70kPa to 106kPa
●Transportation and storage environment:
Temperature: -20℃(-4
) to +55℃ (131)
Relative humidity: 15% to 90%(no condensation)
Atmospheric pressure: 70kPa to 106kPa
When body temperature is 37.6 ℃(99.7) or higher,
the device will make sounds as "di-di-di" to prompt.
●Object temperature mode (Measure temperature
of object)
Short press the mode button in the power-on state,
and the display icon flashes to switch between body
temperature mode and object temperature mode.
After selecting " "(object temperature mode),
approach the object to be measured and press the
Power On/ Measure Button " " to display the
measurement result.
When the measured result is beyond device
measurement range Object temperature mode:
0.0℃~60.0℃(32.0~140.0), the thermometer will
make sounds as "di-di-di" to prompt, at the same
time, " " or " " appears on the display interface.
Notes: Please make sure the measurement method
and the external environment is normal at this time.
●Memory function : press memory button, memory
value inquiry can be carried out. Thermometer can
store 32 groups of memory values. When the
number of groups exceeds the specified number, the
latest memory value will cover the earliest memory
value.
●In memory mode, press and hold memory button,
when CLr is displayed on the screen, the memory
value is cleared.
●Sound switch setting
Step 1: In the shutdown state, long press the mode
button until the temperature unit flashes.
Step 2: Then short press memory button to switch to
sound setting.
Step 3: Press mode button to select sound on " "
or sound off " ".
Step 4: Press the Power On/ Measure Button " " to
confirm.
●Power off
In the absence of any operation, the device will
automatically shut down within 2 minutes.
6. Cleaning and Disinfection
Manual cleaning procedure
1. Use a clean and dry soft cloth or cotton swab to
gently wipe the sensor lens for a minimum of 30
seconds.
2. Thoroughly wipe the device surfaces with a
non-linting cloth dampened (not dripping) with soap
solution for at least three (3) minutes. And wipe the
device surface with a non-linting cloth dampened
(not dripping) with bottled water for at least three (3)
minutes.
NOTE: Prepare the cleaning solution according to the
detergent manufacturers instructions. (e.g.,
Alconox
® Powdered Precision Cleaner, 10 g/L)
NOTE: Pay extra attention to the device's cracks,
crevices, and hard-to-reach areas.
3. Dry the device thoroughly with a soft, clean,
non-linting cloth.
Post-cleaning inspection
Inspect the device visually after cleaning for
cleanliness, damage, and missing or illegible device
labeling or markings:
1.If any visible dirt or residue remains, repeat the
cleaning procedure.
2.Any damaged device should be removed from use.
Damage may include, but is not limited to, corrosion,
discoloration, excessive scratches, flaking, cracks,
and wear.
3. Remove any device with missing, illegible device
labeling or marking from use.
Disinfection procedure
1. Clean the device before disinfection.
2. With the probe facing down, wipe the device
surfaces with a non-linting cloth dampened (not
dripping) with 70% Isopropyl Alcohol (IPA).
3. Allow all surfaces to remain wet for at least two (2)
minutes. If necessary, use additional wipes to
ensure the surfaces remain wet for the full duration.
4. Dry thoroughly with a soft, clean, non-linting cloth.
5. Allow at least five (5) minutes of drying before
taking a temperature reading. Make sure the probe
lens is clean and dry before use.
7. Troubleshooting Instructions
Replace with
new batteries
The
screen
display
" "
The power of
batteries is shortage
The
screen
display
" "
Please contact
the dealer and
send it to the
factory for repair
Infrared sensor
sampling error
Please
remeasure
following the
product
instruction
Place the infrared
thermometer at
an ambient
temperature of 10℃
to 40℃ (50 to
104) and let it
stand for 30
minutes before
measuring. If the
problem persists,
please contact
the dealer and
send it to the
factory for repair
No display
The batteries are
not installed well
Low battery
Check if the
batteries are
installed upside
down
Replace with
new batteries
Please contact
the dealer and
send it to the
factory for repair
The screen is
still blank
9. Technical Specification
●Power source: DC 3V (2×1.5V AAA alkaline batteries)
●Measurement range in body temperature mode:
22.0℃~43.0℃(71.6~109.4)
●Display resolution: 0.1℃(0.1)
●Measurement accuracy:±0.2℃(±0.4) in the
range of 35.0℃~42.0℃(95.0~107.6); ±0.3℃
(±0.5) in the range of 22.0℃~34.9℃(71.6
94.8) and 42.1℃~43.0℃(107.8~109.4)
The positive and
negative poles of the
batteries are
reversed or the
device is abnormal
Reinstall the
batteries, or
contact the
dealer
5. Setup and Use
●Installing the battery
The device is supplied with
2 AAA alkaline batteries. Push
the battery cover downward and
load the battery into the battery
compartment. At this time, the
device will start self-inspection.
Pay attention to the positive and
negative poles instruction in the
battery compartment and snap
the battery cover back onto the
device. Refer to the picture at right:
●Setting measure unit
In the shutdown state, long press the mode button
until the unit symbol flashes, then short press the
mode button to select the temperature units " " and
" ", and press the Power On/ Measure Button" "
to confirm.
●Body temperature mode (Measure temperature of
human body)
1. Point the infrared thermometer probe at the center
of the eyebrows and keep a distance of 0-3 cm from
the forehead (non-contact).
2. Press the Power On/ Measure Button" ". After
about 1 second, the infrared thermometer will have a
prompt of sound and display the measurement results.
When the measured result is beyond device
measurement range Body temperature mode:
22.0℃~43.0℃(71.6~109.4); the thermometer
will make one quick continuous sounds as "di-di-di"
to prompt, at the same time, " " or " " appears on
the display interface, accompanied by an orange
backlight.
●According to ISO 80601-2-56, Rated output
range: 34.0℃ to 42.0℃(93.2 to 107.6). Rated
extended output range: 22.0℃ to 33.9℃ (71.6 to
93.0) and 42.1℃ to 43.0℃ (107.6 to 109.4)
●Electric shock protection: the device is supplied by
internal power
●Operation mode: continuous operation
●Temperature units: ℃/
●Body temperature mode measuring site: forehead
●Time interval of each measurement ≤1s.
●Measurement time: ≤1s.
●Degrees of protection provided by enclosures
(IP code): IP22
●Safety classification: the device that cannot be
used in the presence of flammable anesthetic gases
mixed with air or oxygen or nitrous oxide
●Product size: 6" ×1.5"×1.7"
(152mm×38mm×43mm)
●Product weight: About 0.15 lbs. (70g) (not
including battery)
●Number of memory groups: 32 groups
●Service life: 5 years
●The thermometer uses an adjusted mode when
measuring the body temperature.
●Battery replacement cycle: use the new battery for
no less than 3000 measurements
●Wireless connection: Bluetooth
●Frequency range: 2.400 GHz~2.4835 GHz
●Modulation mode: GFSK
●Transmitting power: ≤20dBm
●FCC ID: 2A2JJ-YHW-6
Recommended Range: ~10 feet (~3 meters)
line-of-sight
Quality of Service (QoS): Delay <10 seconds
This thermometer meets ASTM Standard E
1965-98 requirements. Full responsibility for the
conformance of this device to the standard is
assumed by JIANGSU YUYUE MEDICAL &
SUPPLY CO.,LTD..
ASTM laboratory accuracy requirements for
infrared thermometer in the display range of 37℃
39℃ (98 102) is ±0.2℃(±0.4), while for
mercury-in-glass and electronic thermometers, the
requirement, according to ASTM Standards
E667-86 and E1112-86 is ±0.1℃ (±0.2).
●The clinical validation was conducted according to
the requirements of ISO 80601-2-56. Take the
result measured by mercury thermometer from oral
cavity as the reference. Test three groups: 0 to 1
year old, older than 1 year and younger than 5
years, older than 5 years. The minimum number of
subjects in an age group shall be at least 35. The
test results are shown in the table below:
●Appendix:
Instructions, 2 AAA alkaline batteries
APP Quick Guide(for YHW-6).
●The thermometer uses an infrared sensor, which
can sense the ambient temperature and the infrared
heat radiation emitted by the human body.Referring
to the corresponding parameter table, the best core
algorithm is used to calculate the accurate tempera-
ture.
●Intended purpose: This device is used to measure
the forehead temperature of the human body. It is
intended for use on people of all ages except
pre-term babies or very small(small for gestational
age) babies.
●Indication: Intermittent measurement of human
body temperature from forehead, not for emergency
clinical condition.
●Intended users: Intended users: Health care
professional, or lay persons at least 11 years old.
●Clinical benefits: The device can be used to
measure body temperature so as to help to diagnose
body condition. The clinical benefit associated with
the device is defined as indirect, all intended patient
population can experience the benefit.
●Contraindication: None.
●The device is for professional use and consumer
use.
●Patient can take measurement by themselves, or
they can be taken by someone else using a
thermometer. Patients can perform all the mainte-
nance.
1. Device Use And Applicant Scope
3. Warnings and Precautions
4. Measurement And Transport Storage
Environment
CAUTION: To avoid dust entering the probe cavity
resulting in inaccurate measurements, install the
cover after each use.
CAUTION: Do not use non-specified detachable parts
and materials, otherwise the product may not work
properly.
CAUTION: This thermometer is not intended to
interpret hypothermic temperatures. If the device
displays a temperature of 36.4℃ (97.5 ) or less, and
the individual is exhibiting atypical symptoms or
behaviors, contact your physician or health care
professional.
CAUTION: Do not mix old and new batteries.
CAUTION: When using the thermometer with a smart
device, keep both devices within the recommended
range of each other (see Specifications for details);
moving outside of this range may cause a loss in
connection with the smart device.
CAUTION: When using the thermometer with a smart
device, keep the devices away from sources that may
interfere with the Bluetooth connection. Other devices
may cause radio frequency interference (RFI), which
may result in a loss of quality of service (see
Specifications for details) for the Bluetooth connection.
Devices that may cause RFI include but are not limited
to: electrocautery equipment, diathermy equipment,
other cellular telephones, wireless PC and tablets,
pagers, RFID devices, MRI, and electromagnetic
security systems.
CAUTION: The user is cautioned that changes or
modifications not expressly approved by the party
responsible for compliance could void the user's
authority to operate the equipment
NOTE: 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.
NOTE: This equipment has been tested and found to
comply with the limits for a Class B digital device,
according to Part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against
harmful interference in a residential installation. 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 encouraged to try to correct the
interference by one or more of the following measures:
●Reorient or relocate the receiving antenna.
The
screen
display
" "
The operating
environment
temperature has
changed
significantly
compared to the
storage
temperature.
Place the
thermometer at
the operating
environment
temperature for
30 minutes
before use.
Manufacturer mark
Symbols
Caution
Recyclable
Manufacturer
Implication
This way up
Fragile, handle with care
Keep dry
Date of manufacture
Serial number
Batch code
Medical device
Protection from ingress of particulates than
12.5mm. Dripping water falling within 15° of
vertical will not have a harmful effect on the
thermometer per IEC 60529
Temperature limit
Humidity limitation
Unique device identifier
Refer to instruction manual
Atmospheric pressure limitation
Catalogue number
UDI
Non-ionizing radiation
Safety and environmental protection use period
for 10 years
Symbol for the marking of electrical and electronic
devices according to Directive 2012/19/EU
10
Bluetooth
MR Unsafe. Not appropriate for use in MR
environment (i.e.: inside the MR magnet room)
●Increase the separation between the equipment and
receiver.
●Consult the dealer or an experienced radio/TV
technician for help.
8. Symbols
background
11 13 14 15 16 17 1812
10. Temperature Sense
YY-THM0015D-01(A/0)
13. Warranty Card
Warranty card
Product name:
Infrared thermometer
Model:
YHW-5/YHW-6
Table 3-Test specifications for ENCLOSURE PORT
IMMUNITY to RF wireless communications equipment
15. Guidance and Manufacturers Declaration
on EMC
1700-1990
2400-2570
GSM 1800;
CMDA 1900;
GSM 1900;
DECT;
LTE Band 1,3,
4,25; UMTS
Bluetooth,
WLAN,
802.11 b/g/n
RFID 2450,
LTE Band 7
1720
1845
1970
2450
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
217 Hz
Test
frequency
(MHz)
Band
a)
(MHz)
Service
a)
Modulation
b)
704-787
450
385
800-960
380-390
430-470
TETRA 400
GMRS 460,
FRS 460
LTE Band
13,17
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
710
745
780
810
870
930
Pulse
modulation
b)
18 Hz
FM
c)
±5 kHz
deviation
1 kHz sine
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
18 Hz
Test
frequency
(MHz)
IMMUNITY
TEST LEVEL
(V/m)
450
385
5240
5500
5785
710
745
780
810
870
930
1720
1845
1970
2450
5240
5500
5785
Pulse
modulation
b)
217 Hz
Maximum
power
(W)
5100-5800
1,8
2
Distance
(m)
WLAN 802.11
a/n
0,3
0,3
27
28
0,2
2
2
0,2
2
0,3
0,3
0,3
0,3
0,3
9
28
28
9
28
NOTE If necessary to achieve the IMMUNITY
TEST LEVEL, the distance between the transmit-
ting antenna and the ME EQUIPMENT or ME
SYSTEM may be reduced to 1 m. The 1 m test
distance is permitted by IEC 61000-4-3.
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.
Compliance
level
±8 kV contact
±15 kV air
30A/m
50Hz or 60Hz
10 V/m
80 MHz to 2.7 GHz
80% AM at 1kHz
Table 2-Compliance information for Immunity test
Table 1-Compliance information for Emission test
Phenomenon
ELECTROSTATIC
DISCHARGE
IEC 61000-4-2
RATED power
frequency
magnetic fields
IEC 61000-4-8
Radiated RF EM fields
IEC 61000-4-3
Emission test
Compliance
Group 1
RF emissions
CISPR 11
RF emissions
CISPR 11
Class B
Electromagnetic Compatibility (EMC) compliance
1.This device has been tested and complies with the
Class B limits for medical devices according to the
IEC 60601-1-2.
2.The thermometer is suitable for both professional
and home use, except near active HF SURGICAL
EQUIPMENT or in RF shielded magnetic resonance
imaging (MRI) rooms.
3.The thermometer measure ranges between 34.0
42.2℃ (93.2℉‒108.0). Accuracy is ±0.2℃
(±0.4) within 35.0℃ 42.0℃ (95.0℉‒107.6),
±0.3℃ (±0.5) beyond this range. When using the
device near strong electromagnetic interference
(e.g., cell phones, microwaves, etc.), it may
temporarily affect accuracy. Please keep the device
away if necessary.
4.WARNING: Do not place the thermometer near or
stack it with other medical devices to avoid potential-
ly inaccurate measurements.
5.WARNING: Portable RF communications
equipment (including peripherals such as antenna
cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the
thermometer. Otherwise, degradation of the
performance of the thermometer could result.
Table 1. Electromagnetic emissions
12. After-sales Service
11. Replacing The Batteries
1.The state of the internal electrical power source
will display a different icon depending on the battery
capacity. When the screen only displays the symbol
" " , prompt to replace the battery as soon as
possible; when the symbol " " is displayed,
replace the battery immediately. Replace with 2 new
AAA batteries, slide open the battery cover and
remove old batteries. Replace the batteries being
sure to align properly as indicated inside the battery
compartment.
2.Remove the battery from the product if it is not
required for extended periods of time in order to
avoid damage to the thermometer resulting from a
leaking battery.
3.To protect the environment, dispose of empty
batteries at appropriate collection sites according to
national or local regulations.
1.The thermometer is calibrated initially when
manufactured. There is no need for readjustment if it
is used according to the instruction. If at anytime you
question the accuracy of the temperature measure-
ment, please contact the manufacturer.
Adjusted mode is for general public and calibration
mode is for after-sale person only.
2.This product provides free maintenance service
for one year. If you need to provide circuit diagram,
necessary materials and maintenance of electrical
circuit for any problem, please contact the
manufacturer.
3. No free warranty service will be provided for the
faults caused by the following use:
1) Failure caused by unauthorized disassembly and
modification of products.
2) Failure caused by product drop.
3) Failure caused by failure to operate according to
the instructions.
4) Failure caused by lack of reasonable mainte-
nance.
5) Damage caused by external force.
4. This product will not cause allergic reaction and
harm to human body during normal use.
5.If the situations cannot be solved or unexpected
problem happens, please consult the local distributor.
6.Any serious incident that has occurred in relation
to the device please report to the manufacturer and
the competent authority of the Member State.
14. Connect To HealthCare+
For details, please refer to the APP Quick Guide.
1.To ensure that the measurement results can be
transmitted through Bluetooth, please keep the
distance between the device and the mobile phone
no more than 10 meters.
2.If you want your body temperature measurements
to be sent to your phone via Bluetooth, get a phone
that supports Android 5.0 and above or IOS 10.0 and
above to download Yuwell HealthCare+.
REFERENCE BODY SITE Oral measurement
CLINICAL
BIAS(
Δcb)
LIMITS OF
AGREEMENT
(LA
CLINICAL
REPEATABI
-LITY(
σr
)
Measuring site of
infrared thermometer
Forehead
Less than
1 year of age
-0.09℃
0.62℃
0.13℃
Aged
1-5 years
-0.17℃
0.95℃
0.21℃
Older than
5 years
-0.10℃
0.95℃
0.22℃
Revision date: Mar. 2026
YHW-5/YHW-6
Infrared Thermometer
User Manual And Technical Instruction
Service life: 5 years. Please read the user manual carefully and
follow the instructions before use. For date of manufacture, please
refer to the packaging.
The picture is for reference only, please refer to the actual product.
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO.,LTD.
No.1 Baisheng Road Development Zone, Danyang,
Jiangsu 212300 CHINA
www.yuwell.com
The normal body temperature of people is a range,
different people's normal body temperature varies,
and individual body temperature will change at
different times.
The normal body temperature of most people is
provided as follows, just for reference.
Axillary temperature:
36.0℃~37.4℃/96.8~99.32
Oral temperature:
36.3℃~37.2℃/97.34~98.96
Rectal temperature:
36.9℃~37.9℃/98.42~100.22
16. Cybersecurity
1.Cybersecurity Controls and Product Specification
Description
(1) The device and the App communicate via
Bluetooth, ensuring secure communication through
a private protocol.
(2) Please ensure that your network environment
has installed and updated firewall and antivirus
software to protect against malicious software and
virus intrusions.
2. Detailed Cybersecurity Implementation Diagram
3. Network Interface and Port Description
4. Support Infrastructure Requirements
(1) Users should only pair the device with their
mobile phones in a secure and trusted environment;
for example:
●Encrypted broadband networks
●Dedicated network lines
●WIFIPersonal portable Wi-Fi
(2) Place the device as far away as possible from
other electronic devices that may cause interfer-
ence. For instance, maintain a certain distance from
other Bluetooth devices, Wi-Fi routers, and
microwave ovens.
(3) It is recommended that users protect their mobile
phones to prevent unauthorized access to personal
data by:
●Setting an automatic keyboard lock on the phone
to prevent unauthorized use;
●Configuring a personal device PIN or password to
unlock the keyboard;
●Installing security protection software on the
phone to guard against viruses, trojans, and other
Infrared
thermom-
eter
Yuwell
HeaithCare+
app
Trust boundary
Date transfer by
Bluetooth
Interface
Interface
functionality
Attribute
Approved
Destination
End-points
Bluetooth
Transmit measured
body temperature values
Outgoing
Yuwell
HealthCare+ application
intrusions.
(4) Please do not install or use the APP on rooted or
jailbroken devices.
5.Software Bill of Materials (SBOM): An international
standard Software Bill of Materials (SBOM) in SPDX
format has been generated, supporting conversion to
other international and industry-standard SBOM
formats such as CycloneDX and SWID. If required,
users can send an email to request the latest SBOM
list.
6. Software and Firmware Download
(1) The App is distributed exclusively through the
Google Play Store and Apple Store. Downloading
software updates from unauthorized channels
increases the risk of cybersecurity vulnerabilities.
Our company bears no responsibility for any
consequences that may arise from such actions.
(2) Users should regularly check and perform
available updates for the APP software to promptly
address potential security vulnerabilities.
7. Security Event Response Design
The device operates fully localized, without commu-
nication to the cloud, and does not handle sensitive
personal data. Data transmission is based on
Bluetooth protocol.
8. Critical Function Protection
The device operates fully localized without network-
ing. Its core functions remain unaffected even if the
device is partially damaged and unusable.
9. Backup and Restore Features
No such function
10. Retention and Recovery of Device Configura-
tion
The device operates fully offline and uses
Bluetooth for communication. There is no risk of
network-based attacks (e.g., DDoS attacks, etc.),
and neither the device nor the app requires security
configurations.
11. Secure configuration of device
The device and app do not have security configura-
tions. Bluetooth communication is used, and the
manufacturer has closed all service ports to prevent
attacks, as confirmed by security testing.
12. Capture of Forensic Evidence
The app does not generate log files because internet
connectivity is absent to transmit log files.
13. Information Concerning Device Cybersecurity
End of Support and End of Life
During the valid service period of the device, our
company will provide continuous tracking and repair
of any security issues that exist with the device. If the
device exceeds its service life, our company cannot
guarantee reasonable software update services for
users. Continued use of the device after support has
ended may pose certain security risks to users, and
it is recommended that users discontinue use of the
device.
14.Information on Securely Decommissioning
Devices
The device does not contain sensitive, confidential,
or proprietary data or software; users can delete all
measurement data on the device and in the app.
Supplier's Declaration of Conformity
47 CFR § 2.1077 Compliance Information
Trade Name:
Product name: Infrared thermometer
Model Number: YHW-6
Responsible party: YUWELL MEDTECH USA LLC
Address: 2152 Serene Ct, Keller, TX 76248
Contact information
Name: Fang Zhang
Telephone number: (206) 639-1311
E-mail address: [email protected]
FCC Compliance Statement
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.
background
11 13 14 15 16 17 1812
10. Temperature Sense
YY-THM0015D-01(A/0)
13. Warranty Card
Warranty card
Product name:
Infrared thermometer
Model:
YHW-5/YHW-6
Table 3-Test specifications for ENCLOSURE PORT
IMMUNITY to RF wireless communications equipment
15. Guidance and Manufacturers Declaration
on EMC
1700-1990
2400-2570
GSM 1800;
CMDA 1900;
GSM 1900;
DECT;
LTE Band 1,3,
4,25; UMTS
Bluetooth,
WLAN,
802.11 b/g/n
RFID 2450,
LTE Band 7
1720
1845
1970
2450
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
217 Hz
Test
frequency
(MHz)
Band
a)
(MHz)
Service
a)
Modulation
b)
704-787
450
385
800-960
380-390
430-470
TETRA 400
GMRS 460,
FRS 460
LTE Band
13,17
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
710
745
780
810
870
930
Pulse
modulation
b)
18 Hz
FM
c)
±5 kHz
deviation
1 kHz sine
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
18 Hz
Test
frequency
(MHz)
IMMUNITY
TEST LEVEL
(V/m)
450
385
5240
5500
5785
710
745
780
810
870
930
1720
1845
1970
2450
5240
5500
5785
Pulse
modulation
b)
217 Hz
Maximum
power
(W)
5100-5800
1,8
2
Distance
(m)
WLAN 802.11
a/n
0,3
0,3
27
28
0,2
2
2
0,2
2
0,3
0,3
0,3
0,3
0,3
9
28
28
9
28
NOTE If necessary to achieve the IMMUNITY
TEST LEVEL, the distance between the transmit-
ting antenna and the ME EQUIPMENT or ME
SYSTEM may be reduced to 1 m. The 1 m test
distance is permitted by IEC 61000-4-3.
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.
Compliance
level
±8 kV contact
±15 kV air
30A/m
50Hz or 60Hz
10 V/m
80 MHz to 2.7 GHz
80% AM at 1kHz
Table 2-Compliance information for Immunity test
Table 1-Compliance information for Emission test
Phenomenon
ELECTROSTATIC
DISCHARGE
IEC 61000-4-2
RATED power
frequency
magnetic fields
IEC 61000-4-8
Radiated RF EM fields
IEC 61000-4-3
Emission test
Compliance
Group 1
RF emissions
CISPR 11
RF emissions
CISPR 11
Class B
Electromagnetic Compatibility (EMC) compliance
1.This device has been tested and complies with the
Class B limits for medical devices according to the
IEC 60601-1-2.
2.The thermometer is suitable for both professional
and home use, except near active HF SURGICAL
EQUIPMENT or in RF shielded magnetic resonance
imaging (MRI) rooms.
3.The thermometer measure ranges between 34.0
42.2℃ (93.2℉‒108.0). Accuracy is ±0.2℃
(±0.4) within 35.0℃ 42.0℃ (95.0℉‒107.6),
±0.3℃ (±0.5) beyond this range. When using the
device near strong electromagnetic interference
(e.g., cell phones, microwaves, etc.), it may
temporarily affect accuracy. Please keep the device
away if necessary.
4.WARNING: Do not place the thermometer near or
stack it with other medical devices to avoid potential-
ly inaccurate measurements.
5.WARNING: Portable RF communications
equipment (including peripherals such as antenna
cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the
thermometer. Otherwise, degradation of the
performance of the thermometer could result.
Table 1. Electromagnetic emissions
12. After-sales Service
11. Replacing The Batteries
1.The state of the internal electrical power source
will display a different icon depending on the battery
capacity. When the screen only displays the symbol
" " , prompt to replace the battery as soon as
possible; when the symbol " " is displayed,
replace the battery immediately. Replace with 2 new
AAA batteries, slide open the battery cover and
remove old batteries. Replace the batteries being
sure to align properly as indicated inside the battery
compartment.
2.Remove the battery from the product if it is not
required for extended periods of time in order to
avoid damage to the thermometer resulting from a
leaking battery.
3.To protect the environment, dispose of empty
batteries at appropriate collection sites according to
national or local regulations.
1.The thermometer is calibrated initially when
manufactured. There is no need for readjustment if it
is used according to the instruction. If at anytime you
question the accuracy of the temperature measure-
ment, please contact the manufacturer.
Adjusted mode is for general public and calibration
mode is for after-sale person only.
2.This product provides free maintenance service
for one year. If you need to provide circuit diagram,
necessary materials and maintenance of electrical
circuit for any problem, please contact the
manufacturer.
3. No free warranty service will be provided for the
faults caused by the following use:
1) Failure caused by unauthorized disassembly and
modification of products.
2) Failure caused by product drop.
3) Failure caused by failure to operate according to
the instructions.
4) Failure caused by lack of reasonable mainte-
nance.
5) Damage caused by external force.
4. This product will not cause allergic reaction and
harm to human body during normal use.
5.If the situations cannot be solved or unexpected
problem happens, please consult the local distributor.
6.Any serious incident that has occurred in relation
to the device please report to the manufacturer and
the competent authority of the Member State.
14. Connect To HealthCare+
For details, please refer to the APP Quick Guide.
1.To ensure that the measurement results can be
transmitted through Bluetooth, please keep the
distance between the device and the mobile phone
no more than 10 meters.
2.If you want your body temperature measurements
to be sent to your phone via Bluetooth, get a phone
that supports Android 5.0 and above or IOS 10.0 and
above to download Yuwell HealthCare+.
REFERENCE BODY SITE Oral measurement
CLINICAL
BIAS(
Δcb)
LIMITS OF
AGREEMENT
(LA
CLINICAL
REPEATABI
-LITY(
σr
)
Measuring site of
infrared thermometer
Forehead
Less than
1 year of age
-0.09℃
0.62℃
0.13℃
Aged
1-5 years
-0.17℃
0.95℃
0.21℃
Older than
5 years
-0.10℃
0.95℃
0.22℃
Revision date: Mar. 2026
YHW-5/YHW-6
Infrared Thermometer
User Manual And Technical Instruction
Service life: 5 years. Please read the user manual carefully and
follow the instructions before use. For date of manufacture, please
refer to the packaging.
The picture is for reference only, please refer to the actual product.
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO.,LTD.
No.1 Baisheng Road Development Zone, Danyang,
Jiangsu 212300 CHINA
www.yuwell.com
The normal body temperature of people is a range,
different people's normal body temperature varies,
and individual body temperature will change at
different times.
The normal body temperature of most people is
provided as follows, just for reference.
Axillary temperature:
36.0℃~37.4℃/96.8~99.32
Oral temperature:
36.3℃~37.2℃/97.34~98.96
Rectal temperature:
36.9℃~37.9℃/98.42~100.22
16. Cybersecurity
1.Cybersecurity Controls and Product Specification
Description
(1) The device and the App communicate via
Bluetooth, ensuring secure communication through
a private protocol.
(2) Please ensure that your network environment
has installed and updated firewall and antivirus
software to protect against malicious software and
virus intrusions.
2. Detailed Cybersecurity Implementation Diagram
3. Network Interface and Port Description
4. Support Infrastructure Requirements
(1) Users should only pair the device with their
mobile phones in a secure and trusted environment;
for example:
●Encrypted broadband networks
●Dedicated network lines
●WIFIPersonal portable Wi-Fi
(2) Place the device as far away as possible from
other electronic devices that may cause interfer-
ence. For instance, maintain a certain distance from
other Bluetooth devices, Wi-Fi routers, and
microwave ovens.
(3) It is recommended that users protect their mobile
phones to prevent unauthorized access to personal
data by:
●Setting an automatic keyboard lock on the phone
to prevent unauthorized use;
●Configuring a personal device PIN or password to
unlock the keyboard;
●Installing security protection software on the
phone to guard against viruses, trojans, and other
Infrared
thermom-
eter
Yuwell
HeaithCare+
app
Trust boundary
Date transfer by
Bluetooth
Interface
Interface
functionality
Attribute
Approved
Destination
End-points
Bluetooth
Transmit measured
body temperature values
Outgoing
Yuwell
HealthCare+ application
intrusions.
(4) Please do not install or use the APP on rooted or
jailbroken devices.
5.Software Bill of Materials (SBOM): An international
standard Software Bill of Materials (SBOM) in SPDX
format has been generated, supporting conversion to
other international and industry-standard SBOM
formats such as CycloneDX and SWID. If required,
users can send an email to request the latest SBOM
list.
6. Software and Firmware Download
(1) The App is distributed exclusively through the
Google Play Store and Apple Store. Downloading
software updates from unauthorized channels
increases the risk of cybersecurity vulnerabilities.
Our company bears no responsibility for any
consequences that may arise from such actions.
(2) Users should regularly check and perform
available updates for the APP software to promptly
address potential security vulnerabilities.
7. Security Event Response Design
The device operates fully localized, without commu-
nication to the cloud, and does not handle sensitive
personal data. Data transmission is based on
Bluetooth protocol.
8. Critical Function Protection
The device operates fully localized without network-
ing. Its core functions remain unaffected even if the
device is partially damaged and unusable.
9. Backup and Restore Features
No such function
10. Retention and Recovery of Device Configura-
tion
The device operates fully offline and uses
Bluetooth for communication. There is no risk of
network-based attacks (e.g., DDoS attacks, etc.),
and neither the device nor the app requires security
configurations.
11. Secure configuration of device
The device and app do not have security configura-
tions. Bluetooth communication is used, and the
manufacturer has closed all service ports to prevent
attacks, as confirmed by security testing.
12. Capture of Forensic Evidence
The app does not generate log files because internet
connectivity is absent to transmit log files.
13. Information Concerning Device Cybersecurity
End of Support and End of Life
During the valid service period of the device, our
company will provide continuous tracking and repair
of any security issues that exist with the device. If the
device exceeds its service life, our company cannot
guarantee reasonable software update services for
users. Continued use of the device after support has
ended may pose certain security risks to users, and
it is recommended that users discontinue use of the
device.
14.Information on Securely Decommissioning
Devices
The device does not contain sensitive, confidential,
or proprietary data or software; users can delete all
measurement data on the device and in the app.
Supplier's Declaration of Conformity
47 CFR § 2.1077 Compliance Information
Trade Name:
Product name: Infrared thermometer
Model Number: YHW-6
Responsible party: YUWELL MEDTECH USA LLC
Address: 2152 Serene Ct, Keller, TX 76248
Contact information
Name: Fang Zhang
Telephone number: (206) 639-1311
E-mail address: [email protected]
FCC Compliance Statement
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.
background
11 13 14 15 16 17 1812
10. Temperature Sense
YY-THM0015D-01(A/0)
13. Warranty Card
Warranty card
Product name:
Infrared thermometer
Model:
YHW-5/YHW-6
Table 3-Test specifications for ENCLOSURE PORT
IMMUNITY to RF wireless communications equipment
15. Guidance and Manufacturers Declaration
on EMC
1700-1990
2400-2570
GSM 1800;
CMDA 1900;
GSM 1900;
DECT;
LTE Band 1,3,
4,25; UMTS
Bluetooth,
WLAN,
802.11 b/g/n
RFID 2450,
LTE Band 7
1720
1845
1970
2450
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
217 Hz
Test
frequency
(MHz)
Band
a)
(MHz)
Service
a)
Modulation
b)
704-787
450
385
800-960
380-390
430-470
TETRA 400
GMRS 460,
FRS 460
LTE Band
13,17
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
710
745
780
810
870
930
Pulse
modulation
b)
18 Hz
FM
c)
±5 kHz
deviation
1 kHz sine
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
18 Hz
Test
frequency
(MHz)
IMMUNITY
TEST LEVEL
(V/m)
450
385
5240
5500
5785
710
745
780
810
870
930
1720
1845
1970
2450
5240
5500
5785
Pulse
modulation
b)
217 Hz
Maximum
power
(W)
5100-5800
1,8
2
Distance
(m)
WLAN 802.11
a/n
0,3
0,3
27
28
0,2
2
2
0,2
2
0,3
0,3
0,3
0,3
0,3
9
28
28
9
28
NOTE If necessary to achieve the IMMUNITY
TEST LEVEL, the distance between the transmit-
ting antenna and the ME EQUIPMENT or ME
SYSTEM may be reduced to 1 m. The 1 m test
distance is permitted by IEC 61000-4-3.
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.
Compliance
level
±8 kV contact
±15 kV air
30A/m
50Hz or 60Hz
10 V/m
80 MHz to 2.7 GHz
80% AM at 1kHz
Table 2-Compliance information for Immunity test
Table 1-Compliance information for Emission test
Phenomenon
ELECTROSTATIC
DISCHARGE
IEC 61000-4-2
RATED power
frequency
magnetic fields
IEC 61000-4-8
Radiated RF EM fields
IEC 61000-4-3
Emission test
Compliance
Group 1
RF emissions
CISPR 11
RF emissions
CISPR 11
Class B
Electromagnetic Compatibility (EMC) compliance
1.This device has been tested and complies with the
Class B limits for medical devices according to the
IEC 60601-1-2.
2.The thermometer is suitable for both professional
and home use, except near active HF SURGICAL
EQUIPMENT or in RF shielded magnetic resonance
imaging (MRI) rooms.
3.The thermometer measure ranges between 34.0
42.2℃ (93.2℉‒108.0). Accuracy is ±0.2℃
(±0.4) within 35.0℃ 42.0℃ (95.0℉‒107.6),
±0.3℃ (±0.5) beyond this range. When using the
device near strong electromagnetic interference
(e.g., cell phones, microwaves, etc.), it may
temporarily affect accuracy. Please keep the device
away if necessary.
4.WARNING: Do not place the thermometer near or
stack it with other medical devices to avoid potential-
ly inaccurate measurements.
5.WARNING: Portable RF communications
equipment (including peripherals such as antenna
cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the
thermometer. Otherwise, degradation of the
performance of the thermometer could result.
Table 1. Electromagnetic emissions
12. After-sales Service
11. Replacing The Batteries
1.The state of the internal electrical power source
will display a different icon depending on the battery
capacity. When the screen only displays the symbol
" " , prompt to replace the battery as soon as
possible; when the symbol " " is displayed,
replace the battery immediately. Replace with 2 new
AAA batteries, slide open the battery cover and
remove old batteries. Replace the batteries being
sure to align properly as indicated inside the battery
compartment.
2.Remove the battery from the product if it is not
required for extended periods of time in order to
avoid damage to the thermometer resulting from a
leaking battery.
3.To protect the environment, dispose of empty
batteries at appropriate collection sites according to
national or local regulations.
1.The thermometer is calibrated initially when
manufactured. There is no need for readjustment if it
is used according to the instruction. If at anytime you
question the accuracy of the temperature measure-
ment, please contact the manufacturer.
Adjusted mode is for general public and calibration
mode is for after-sale person only.
2.This product provides free maintenance service
for one year. If you need to provide circuit diagram,
necessary materials and maintenance of electrical
circuit for any problem, please contact the
manufacturer.
3. No free warranty service will be provided for the
faults caused by the following use:
1) Failure caused by unauthorized disassembly and
modification of products.
2) Failure caused by product drop.
3) Failure caused by failure to operate according to
the instructions.
4) Failure caused by lack of reasonable mainte-
nance.
5) Damage caused by external force.
4. This product will not cause allergic reaction and
harm to human body during normal use.
5.If the situations cannot be solved or unexpected
problem happens, please consult the local distributor.
6.Any serious incident that has occurred in relation
to the device please report to the manufacturer and
the competent authority of the Member State.
14. Connect To HealthCare+
For details, please refer to the APP Quick Guide.
1.To ensure that the measurement results can be
transmitted through Bluetooth, please keep the
distance between the device and the mobile phone
no more than 10 meters.
2.If you want your body temperature measurements
to be sent to your phone via Bluetooth, get a phone
that supports Android 5.0 and above or IOS 10.0 and
above to download Yuwell HealthCare+.
REFERENCE BODY SITE Oral measurement
CLINICAL
BIAS(
Δcb)
LIMITS OF
AGREEMENT
(LA
CLINICAL
REPEATABI
-LITY(
σr
)
Measuring site of
infrared thermometer
Forehead
Less than
1 year of age
-0.09℃
0.62℃
0.13℃
Aged
1-5 years
-0.17℃
0.95℃
0.21℃
Older than
5 years
-0.10℃
0.95℃
0.22℃
Revision date: Mar. 2026
YHW-5/YHW-6
Infrared Thermometer
User Manual And Technical Instruction
Service life: 5 years. Please read the user manual carefully and
follow the instructions before use. For date of manufacture, please
refer to the packaging.
The picture is for reference only, please refer to the actual product.
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO.,LTD.
No.1 Baisheng Road Development Zone, Danyang,
Jiangsu 212300 CHINA
www.yuwell.com
The normal body temperature of people is a range,
different people's normal body temperature varies,
and individual body temperature will change at
different times.
The normal body temperature of most people is
provided as follows, just for reference.
Axillary temperature:
36.0℃~37.4℃/96.8~99.32
Oral temperature:
36.3℃~37.2℃/97.34~98.96
Rectal temperature:
36.9℃~37.9℃/98.42~100.22
16. Cybersecurity
1.Cybersecurity Controls and Product Specification
Description
(1) The device and the App communicate via
Bluetooth, ensuring secure communication through
a private protocol.
(2) Please ensure that your network environment
has installed and updated firewall and antivirus
software to protect against malicious software and
virus intrusions.
2. Detailed Cybersecurity Implementation Diagram
3. Network Interface and Port Description
4. Support Infrastructure Requirements
(1) Users should only pair the device with their
mobile phones in a secure and trusted environment;
for example:
●Encrypted broadband networks
●Dedicated network lines
●WIFIPersonal portable Wi-Fi
(2) Place the device as far away as possible from
other electronic devices that may cause interfer-
ence. For instance, maintain a certain distance from
other Bluetooth devices, Wi-Fi routers, and
microwave ovens.
(3) It is recommended that users protect their mobile
phones to prevent unauthorized access to personal
data by:
●Setting an automatic keyboard lock on the phone
to prevent unauthorized use;
●Configuring a personal device PIN or password to
unlock the keyboard;
●Installing security protection software on the
phone to guard against viruses, trojans, and other
Infrared
thermom-
eter
Yuwell
HeaithCare+
app
Trust boundary
Date transfer by
Bluetooth
Interface
Interface
functionality
Attribute
Approved
Destination
End-points
Bluetooth
Transmit measured
body temperature values
Outgoing
Yuwell
HealthCare+ application
intrusions.
(4) Please do not install or use the APP on rooted or
jailbroken devices.
5.Software Bill of Materials (SBOM): An international
standard Software Bill of Materials (SBOM) in SPDX
format has been generated, supporting conversion to
other international and industry-standard SBOM
formats such as CycloneDX and SWID. If required,
users can send an email to request the latest SBOM
list.
6. Software and Firmware Download
(1) The App is distributed exclusively through the
Google Play Store and Apple Store. Downloading
software updates from unauthorized channels
increases the risk of cybersecurity vulnerabilities.
Our company bears no responsibility for any
consequences that may arise from such actions.
(2) Users should regularly check and perform
available updates for the APP software to promptly
address potential security vulnerabilities.
7. Security Event Response Design
The device operates fully localized, without commu-
nication to the cloud, and does not handle sensitive
personal data. Data transmission is based on
Bluetooth protocol.
8. Critical Function Protection
The device operates fully localized without network-
ing. Its core functions remain unaffected even if the
device is partially damaged and unusable.
9. Backup and Restore Features
No such function
10. Retention and Recovery of Device Configura-
tion
The device operates fully offline and uses
Bluetooth for communication. There is no risk of
network-based attacks (e.g., DDoS attacks, etc.),
and neither the device nor the app requires security
configurations.
11. Secure configuration of device
The device and app do not have security configura-
tions. Bluetooth communication is used, and the
manufacturer has closed all service ports to prevent
attacks, as confirmed by security testing.
12. Capture of Forensic Evidence
The app does not generate log files because internet
connectivity is absent to transmit log files.
13. Information Concerning Device Cybersecurity
End of Support and End of Life
During the valid service period of the device, our
company will provide continuous tracking and repair
of any security issues that exist with the device. If the
device exceeds its service life, our company cannot
guarantee reasonable software update services for
users. Continued use of the device after support has
ended may pose certain security risks to users, and
it is recommended that users discontinue use of the
device.
14.Information on Securely Decommissioning
Devices
The device does not contain sensitive, confidential,
or proprietary data or software; users can delete all
measurement data on the device and in the app.
Supplier's Declaration of Conformity
47 CFR § 2.1077 Compliance Information
Trade Name:
Product name: Infrared thermometer
Model Number: YHW-6
Responsible party: YUWELL MEDTECH USA LLC
Address: 2152 Serene Ct, Keller, TX 76248
Contact information
Name: Fang Zhang
Telephone number: (206) 639-1311
E-mail address: [email protected]
FCC Compliance Statement
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.
background
11 13 14 15 16 17 1812
10. Temperature Sense
YY-THM0015D-01(A/0)
13. Warranty Card
Warranty card
Product name:
Infrared thermometer
Model:
YHW-5/YHW-6
Table 3-Test specifications for ENCLOSURE PORT
IMMUNITY to RF wireless communications equipment
15. Guidance and Manufacturers Declaration
on EMC
1700-1990
2400-2570
GSM 1800;
CMDA 1900;
GSM 1900;
DECT;
LTE Band 1,3,
4,25; UMTS
Bluetooth,
WLAN,
802.11 b/g/n
RFID 2450,
LTE Band 7
1720
1845
1970
2450
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
217 Hz
Test
frequency
(MHz)
Band
a)
(MHz)
Service
a)
Modulation
b)
704-787
450
385
800-960
380-390
430-470
TETRA 400
GMRS 460,
FRS 460
LTE Band
13,17
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
710
745
780
810
870
930
Pulse
modulation
b)
18 Hz
FM
c)
±5 kHz
deviation
1 kHz sine
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
18 Hz
Test
frequency
(MHz)
IMMUNITY
TEST LEVEL
(V/m)
450
385
5240
5500
5785
710
745
780
810
870
930
1720
1845
1970
2450
5240
5500
5785
Pulse
modulation
b)
217 Hz
Maximum
power
(W)
5100-5800
1,8
2
Distance
(m)
WLAN 802.11
a/n
0,3
0,3
27
28
0,2
2
2
0,2
2
0,3
0,3
0,3
0,3
0,3
9
28
28
9
28
NOTE If necessary to achieve the IMMUNITY
TEST LEVEL, the distance between the transmit-
ting antenna and the ME EQUIPMENT or ME
SYSTEM may be reduced to 1 m. The 1 m test
distance is permitted by IEC 61000-4-3.
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.
Compliance
level
±8 kV contact
±15 kV air
30A/m
50Hz or 60Hz
10 V/m
80 MHz to 2.7 GHz
80% AM at 1kHz
Table 2-Compliance information for Immunity test
Table 1-Compliance information for Emission test
Phenomenon
ELECTROSTATIC
DISCHARGE
IEC 61000-4-2
RATED power
frequency
magnetic fields
IEC 61000-4-8
Radiated RF EM fields
IEC 61000-4-3
Emission test
Compliance
Group 1
RF emissions
CISPR 11
RF emissions
CISPR 11
Class B
Electromagnetic Compatibility (EMC) compliance
1.This device has been tested and complies with the
Class B limits for medical devices according to the
IEC 60601-1-2.
2.The thermometer is suitable for both professional
and home use, except near active HF SURGICAL
EQUIPMENT or in RF shielded magnetic resonance
imaging (MRI) rooms.
3.The thermometer measure ranges between 34.0
42.2℃ (93.2℉‒108.0). Accuracy is ±0.2℃
(±0.4) within 35.0℃ 42.0℃ (95.0℉‒107.6),
±0.3℃ (±0.5) beyond this range. When using the
device near strong electromagnetic interference
(e.g., cell phones, microwaves, etc.), it may
temporarily affect accuracy. Please keep the device
away if necessary.
4.WARNING: Do not place the thermometer near or
stack it with other medical devices to avoid potential-
ly inaccurate measurements.
5.WARNING: Portable RF communications
equipment (including peripherals such as antenna
cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the
thermometer. Otherwise, degradation of the
performance of the thermometer could result.
Table 1. Electromagnetic emissions
12. After-sales Service
11. Replacing The Batteries
1.The state of the internal electrical power source
will display a different icon depending on the battery
capacity. When the screen only displays the symbol
" " , prompt to replace the battery as soon as
possible; when the symbol " " is displayed,
replace the battery immediately. Replace with 2 new
AAA batteries, slide open the battery cover and
remove old batteries. Replace the batteries being
sure to align properly as indicated inside the battery
compartment.
2.Remove the battery from the product if it is not
required for extended periods of time in order to
avoid damage to the thermometer resulting from a
leaking battery.
3.To protect the environment, dispose of empty
batteries at appropriate collection sites according to
national or local regulations.
1.The thermometer is calibrated initially when
manufactured. There is no need for readjustment if it
is used according to the instruction. If at anytime you
question the accuracy of the temperature measure-
ment, please contact the manufacturer.
Adjusted mode is for general public and calibration
mode is for after-sale person only.
2.This product provides free maintenance service
for one year. If you need to provide circuit diagram,
necessary materials and maintenance of electrical
circuit for any problem, please contact the
manufacturer.
3. No free warranty service will be provided for the
faults caused by the following use:
1) Failure caused by unauthorized disassembly and
modification of products.
2) Failure caused by product drop.
3) Failure caused by failure to operate according to
the instructions.
4) Failure caused by lack of reasonable mainte-
nance.
5) Damage caused by external force.
4. This product will not cause allergic reaction and
harm to human body during normal use.
5.If the situations cannot be solved or unexpected
problem happens, please consult the local distributor.
6.Any serious incident that has occurred in relation
to the device please report to the manufacturer and
the competent authority of the Member State.
14. Connect To HealthCare+
For details, please refer to the APP Quick Guide.
1.To ensure that the measurement results can be
transmitted through Bluetooth, please keep the
distance between the device and the mobile phone
no more than 10 meters.
2.If you want your body temperature measurements
to be sent to your phone via Bluetooth, get a phone
that supports Android 5.0 and above or IOS 10.0 and
above to download Yuwell HealthCare+.
REFERENCE BODY SITE Oral measurement
CLINICAL
BIAS(
Δcb)
LIMITS OF
AGREEMENT
(LA
CLINICAL
REPEATABI
-LITY(
σr
)
Measuring site of
infrared thermometer
Forehead
Less than
1 year of age
-0.09℃
0.62℃
0.13℃
Aged
1-5 years
-0.17℃
0.95℃
0.21℃
Older than
5 years
-0.10℃
0.95℃
0.22℃
Revision date: Mar. 2026
YHW-5/YHW-6
Infrared Thermometer
User Manual And Technical Instruction
Service life: 5 years. Please read the user manual carefully and
follow the instructions before use. For date of manufacture, please
refer to the packaging.
The picture is for reference only, please refer to the actual product.
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO.,LTD.
No.1 Baisheng Road Development Zone, Danyang,
Jiangsu 212300 CHINA
www.yuwell.com
The normal body temperature of people is a range,
different people's normal body temperature varies,
and individual body temperature will change at
different times.
The normal body temperature of most people is
provided as follows, just for reference.
Axillary temperature:
36.0℃~37.4℃/96.8~99.32
Oral temperature:
36.3℃~37.2℃/97.34~98.96
Rectal temperature:
36.9℃~37.9℃/98.42~100.22
16. Cybersecurity
1.Cybersecurity Controls and Product Specification
Description
(1) The device and the App communicate via
Bluetooth, ensuring secure communication through
a private protocol.
(2) Please ensure that your network environment
has installed and updated firewall and antivirus
software to protect against malicious software and
virus intrusions.
2. Detailed Cybersecurity Implementation Diagram
3. Network Interface and Port Description
4. Support Infrastructure Requirements
(1) Users should only pair the device with their
mobile phones in a secure and trusted environment;
for example:
●Encrypted broadband networks
●Dedicated network lines
●WIFIPersonal portable Wi-Fi
(2) Place the device as far away as possible from
other electronic devices that may cause interfer-
ence. For instance, maintain a certain distance from
other Bluetooth devices, Wi-Fi routers, and
microwave ovens.
(3) It is recommended that users protect their mobile
phones to prevent unauthorized access to personal
data by:
●Setting an automatic keyboard lock on the phone
to prevent unauthorized use;
●Configuring a personal device PIN or password to
unlock the keyboard;
●Installing security protection software on the
phone to guard against viruses, trojans, and other
Infrared
thermom-
eter
Yuwell
HeaithCare+
app
Trust boundary
Date transfer by
Bluetooth
Interface
Interface
functionality
Attribute
Approved
Destination
End-points
Bluetooth
Transmit measured
body temperature values
Outgoing
Yuwell
HealthCare+ application
intrusions.
(4) Please do not install or use the APP on rooted or
jailbroken devices.
5.Software Bill of Materials (SBOM): An international
standard Software Bill of Materials (SBOM) in SPDX
format has been generated, supporting conversion to
other international and industry-standard SBOM
formats such as CycloneDX and SWID. If required,
users can send an email to request the latest SBOM
list.
6. Software and Firmware Download
(1) The App is distributed exclusively through the
Google Play Store and Apple Store. Downloading
software updates from unauthorized channels
increases the risk of cybersecurity vulnerabilities.
Our company bears no responsibility for any
consequences that may arise from such actions.
(2) Users should regularly check and perform
available updates for the APP software to promptly
address potential security vulnerabilities.
7. Security Event Response Design
The device operates fully localized, without commu-
nication to the cloud, and does not handle sensitive
personal data. Data transmission is based on
Bluetooth protocol.
8. Critical Function Protection
The device operates fully localized without network-
ing. Its core functions remain unaffected even if the
device is partially damaged and unusable.
9. Backup and Restore Features
No such function
10. Retention and Recovery of Device Configura-
tion
The device operates fully offline and uses
Bluetooth for communication. There is no risk of
network-based attacks (e.g., DDoS attacks, etc.),
and neither the device nor the app requires security
configurations.
11. Secure configuration of device
The device and app do not have security configura-
tions. Bluetooth communication is used, and the
manufacturer has closed all service ports to prevent
attacks, as confirmed by security testing.
12. Capture of Forensic Evidence
The app does not generate log files because internet
connectivity is absent to transmit log files.
13. Information Concerning Device Cybersecurity
End of Support and End of Life
During the valid service period of the device, our
company will provide continuous tracking and repair
of any security issues that exist with the device. If the
device exceeds its service life, our company cannot
guarantee reasonable software update services for
users. Continued use of the device after support has
ended may pose certain security risks to users, and
it is recommended that users discontinue use of the
device.
14.Information on Securely Decommissioning
Devices
The device does not contain sensitive, confidential,
or proprietary data or software; users can delete all
measurement data on the device and in the app.
Supplier's Declaration of Conformity
47 CFR § 2.1077 Compliance Information
Trade Name:
Product name: Infrared thermometer
Model Number: YHW-6
Responsible party: YUWELL MEDTECH USA LLC
Address: 2152 Serene Ct, Keller, TX 76248
Contact information
Name: Fang Zhang
Telephone number: (206) 639-1311
E-mail address: [email protected]
FCC Compliance Statement
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.
background
11 13 14 15 16 17 1812
10. Temperature Sense
YY-THM0015D-01(A/0)
13. Warranty Card
Warranty card
Product name:
Infrared thermometer
Model:
YHW-5/YHW-6
Table 3-Test specifications for ENCLOSURE PORT
IMMUNITY to RF wireless communications equipment
15. Guidance and Manufacturers Declaration
on EMC
1700-1990
2400-2570
GSM 1800;
CMDA 1900;
GSM 1900;
DECT;
LTE Band 1,3,
4,25; UMTS
Bluetooth,
WLAN,
802.11 b/g/n
RFID 2450,
LTE Band 7
1720
1845
1970
2450
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
217 Hz
Test
frequency
(MHz)
Band
a)
(MHz)
Service
a)
Modulation
b)
704-787
450
385
800-960
380-390
430-470
TETRA 400
GMRS 460,
FRS 460
LTE Band
13,17
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
710
745
780
810
870
930
Pulse
modulation
b)
18 Hz
FM
c)
±5 kHz
deviation
1 kHz sine
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
18 Hz
Test
frequency
(MHz)
IMMUNITY
TEST LEVEL
(V/m)
450
385
5240
5500
5785
710
745
780
810
870
930
1720
1845
1970
2450
5240
5500
5785
Pulse
modulation
b)
217 Hz
Maximum
power
(W)
5100-5800
1,8
2
Distance
(m)
WLAN 802.11
a/n
0,3
0,3
27
28
0,2
2
2
0,2
2
0,3
0,3
0,3
0,3
0,3
9
28
28
9
28
NOTE If necessary to achieve the IMMUNITY
TEST LEVEL, the distance between the transmit-
ting antenna and the ME EQUIPMENT or ME
SYSTEM may be reduced to 1 m. The 1 m test
distance is permitted by IEC 61000-4-3.
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.
Compliance
level
±8 kV contact
±15 kV air
30A/m
50Hz or 60Hz
10 V/m
80 MHz to 2.7 GHz
80% AM at 1kHz
Table 2-Compliance information for Immunity test
Table 1-Compliance information for Emission test
Phenomenon
ELECTROSTATIC
DISCHARGE
IEC 61000-4-2
RATED power
frequency
magnetic fields
IEC 61000-4-8
Radiated RF EM fields
IEC 61000-4-3
Emission test
Compliance
Group 1
RF emissions
CISPR 11
RF emissions
CISPR 11
Class B
Electromagnetic Compatibility (EMC) compliance
1.This device has been tested and complies with the
Class B limits for medical devices according to the
IEC 60601-1-2.
2.The thermometer is suitable for both professional
and home use, except near active HF SURGICAL
EQUIPMENT or in RF shielded magnetic resonance
imaging (MRI) rooms.
3.The thermometer measure ranges between 34.0
42.2℃ (93.2℉‒108.0). Accuracy is ±0.2℃
(±0.4) within 35.0℃ 42.0℃ (95.0℉‒107.6),
±0.3℃ (±0.5) beyond this range. When using the
device near strong electromagnetic interference
(e.g., cell phones, microwaves, etc.), it may
temporarily affect accuracy. Please keep the device
away if necessary.
4.WARNING: Do not place the thermometer near or
stack it with other medical devices to avoid potential-
ly inaccurate measurements.
5.WARNING: Portable RF communications
equipment (including peripherals such as antenna
cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the
thermometer. Otherwise, degradation of the
performance of the thermometer could result.
Table 1. Electromagnetic emissions
12. After-sales Service
11. Replacing The Batteries
1.The state of the internal electrical power source
will display a different icon depending on the battery
capacity. When the screen only displays the symbol
" " , prompt to replace the battery as soon as
possible; when the symbol " " is displayed,
replace the battery immediately. Replace with 2 new
AAA batteries, slide open the battery cover and
remove old batteries. Replace the batteries being
sure to align properly as indicated inside the battery
compartment.
2.Remove the battery from the product if it is not
required for extended periods of time in order to
avoid damage to the thermometer resulting from a
leaking battery.
3.To protect the environment, dispose of empty
batteries at appropriate collection sites according to
national or local regulations.
1.The thermometer is calibrated initially when
manufactured. There is no need for readjustment if it
is used according to the instruction. If at anytime you
question the accuracy of the temperature measure-
ment, please contact the manufacturer.
Adjusted mode is for general public and calibration
mode is for after-sale person only.
2.This product provides free maintenance service
for one year. If you need to provide circuit diagram,
necessary materials and maintenance of electrical
circuit for any problem, please contact the
manufacturer.
3. No free warranty service will be provided for the
faults caused by the following use:
1) Failure caused by unauthorized disassembly and
modification of products.
2) Failure caused by product drop.
3) Failure caused by failure to operate according to
the instructions.
4) Failure caused by lack of reasonable mainte-
nance.
5) Damage caused by external force.
4. This product will not cause allergic reaction and
harm to human body during normal use.
5.If the situations cannot be solved or unexpected
problem happens, please consult the local distributor.
6.Any serious incident that has occurred in relation
to the device please report to the manufacturer and
the competent authority of the Member State.
14. Connect To HealthCare+
For details, please refer to the APP Quick Guide.
1.To ensure that the measurement results can be
transmitted through Bluetooth, please keep the
distance between the device and the mobile phone
no more than 10 meters.
2.If you want your body temperature measurements
to be sent to your phone via Bluetooth, get a phone
that supports Android 5.0 and above or IOS 10.0 and
above to download Yuwell HealthCare+.
REFERENCE BODY SITE Oral measurement
CLINICAL
BIAS(
Δcb)
LIMITS OF
AGREEMENT
(LA
CLINICAL
REPEATABI
-LITY(
σr
)
Measuring site of
infrared thermometer
Forehead
Less than
1 year of age
-0.09℃
0.62℃
0.13℃
Aged
1-5 years
-0.17℃
0.95℃
0.21℃
Older than
5 years
-0.10℃
0.95℃
0.22℃
Revision date: Mar. 2026
YHW-5/YHW-6
Infrared Thermometer
User Manual And Technical Instruction
Service life: 5 years. Please read the user manual carefully and
follow the instructions before use. For date of manufacture, please
refer to the packaging.
The picture is for reference only, please refer to the actual product.
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO.,LTD.
No.1 Baisheng Road Development Zone, Danyang,
Jiangsu 212300 CHINA
www.yuwell.com
The normal body temperature of people is a range,
different people's normal body temperature varies,
and individual body temperature will change at
different times.
The normal body temperature of most people is
provided as follows, just for reference.
Axillary temperature:
36.0℃~37.4℃/96.8~99.32
Oral temperature:
36.3℃~37.2℃/97.34~98.96
Rectal temperature:
36.9℃~37.9℃/98.42~100.22
16. Cybersecurity
1.Cybersecurity Controls and Product Specification
Description
(1) The device and the App communicate via
Bluetooth, ensuring secure communication through
a private protocol.
(2) Please ensure that your network environment
has installed and updated firewall and antivirus
software to protect against malicious software and
virus intrusions.
2. Detailed Cybersecurity Implementation Diagram
3. Network Interface and Port Description
4. Support Infrastructure Requirements
(1) Users should only pair the device with their
mobile phones in a secure and trusted environment;
for example:
●Encrypted broadband networks
●Dedicated network lines
●WIFIPersonal portable Wi-Fi
(2) Place the device as far away as possible from
other electronic devices that may cause interfer-
ence. For instance, maintain a certain distance from
other Bluetooth devices, Wi-Fi routers, and
microwave ovens.
(3) It is recommended that users protect their mobile
phones to prevent unauthorized access to personal
data by:
●Setting an automatic keyboard lock on the phone
to prevent unauthorized use;
●Configuring a personal device PIN or password to
unlock the keyboard;
●Installing security protection software on the
phone to guard against viruses, trojans, and other
Infrared
thermom-
eter
Yuwell
HeaithCare+
app
Trust boundary
Date transfer by
Bluetooth
Interface
Interface
functionality
Attribute
Approved
Destination
End-points
Bluetooth
Transmit measured
body temperature values
Outgoing
Yuwell
HealthCare+ application
intrusions.
(4) Please do not install or use the APP on rooted or
jailbroken devices.
5.Software Bill of Materials (SBOM): An international
standard Software Bill of Materials (SBOM) in SPDX
format has been generated, supporting conversion to
other international and industry-standard SBOM
formats such as CycloneDX and SWID. If required,
users can send an email to request the latest SBOM
list.
6. Software and Firmware Download
(1) The App is distributed exclusively through the
Google Play Store and Apple Store. Downloading
software updates from unauthorized channels
increases the risk of cybersecurity vulnerabilities.
Our company bears no responsibility for any
consequences that may arise from such actions.
(2) Users should regularly check and perform
available updates for the APP software to promptly
address potential security vulnerabilities.
7. Security Event Response Design
The device operates fully localized, without commu-
nication to the cloud, and does not handle sensitive
personal data. Data transmission is based on
Bluetooth protocol.
8. Critical Function Protection
The device operates fully localized without network-
ing. Its core functions remain unaffected even if the
device is partially damaged and unusable.
9. Backup and Restore Features
No such function
10. Retention and Recovery of Device Configura-
tion
The device operates fully offline and uses
Bluetooth for communication. There is no risk of
network-based attacks (e.g., DDoS attacks, etc.),
and neither the device nor the app requires security
configurations.
11. Secure configuration of device
The device and app do not have security configura-
tions. Bluetooth communication is used, and the
manufacturer has closed all service ports to prevent
attacks, as confirmed by security testing.
12. Capture of Forensic Evidence
The app does not generate log files because internet
connectivity is absent to transmit log files.
13. Information Concerning Device Cybersecurity
End of Support and End of Life
During the valid service period of the device, our
company will provide continuous tracking and repair
of any security issues that exist with the device. If the
device exceeds its service life, our company cannot
guarantee reasonable software update services for
users. Continued use of the device after support has
ended may pose certain security risks to users, and
it is recommended that users discontinue use of the
device.
14.Information on Securely Decommissioning
Devices
The device does not contain sensitive, confidential,
or proprietary data or software; users can delete all
measurement data on the device and in the app.
Supplier's Declaration of Conformity
47 CFR § 2.1077 Compliance Information
Trade Name:
Product name: Infrared thermometer
Model Number: YHW-6
Responsible party: YUWELL MEDTECH USA LLC
Address: 2152 Serene Ct, Keller, TX 76248
Contact information
Name: Fang Zhang
Telephone number: (206) 639-1311
E-mail address: [email protected]
FCC Compliance Statement
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.
background
11 13 14 15 16 17 1812
10. Temperature Sense
YY-THM0015D-01(A/0)
13. Warranty Card
Warranty card
Product name:
Infrared thermometer
Model:
YHW-5/YHW-6
Table 3-Test specifications for ENCLOSURE PORT
IMMUNITY to RF wireless communications equipment
15. Guidance and Manufacturers Declaration
on EMC
1700-1990
2400-2570
GSM 1800;
CMDA 1900;
GSM 1900;
DECT;
LTE Band 1,3,
4,25; UMTS
Bluetooth,
WLAN,
802.11 b/g/n
RFID 2450,
LTE Band 7
1720
1845
1970
2450
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
217 Hz
Test
frequency
(MHz)
Band
a)
(MHz)
Service
a)
Modulation
b)
704-787
450
385
800-960
380-390
430-470
TETRA 400
GMRS 460,
FRS 460
LTE Band
13,17
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
710
745
780
810
870
930
Pulse
modulation
b)
18 Hz
FM
c)
±5 kHz
deviation
1 kHz sine
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
18 Hz
Test
frequency
(MHz)
IMMUNITY
TEST LEVEL
(V/m)
450
385
5240
5500
5785
710
745
780
810
870
930
1720
1845
1970
2450
5240
5500
5785
Pulse
modulation
b)
217 Hz
Maximum
power
(W)
5100-5800
1,8
2
Distance
(m)
WLAN 802.11
a/n
0,3
0,3
27
28
0,2
2
2
0,2
2
0,3
0,3
0,3
0,3
0,3
9
28
28
9
28
NOTE If necessary to achieve the IMMUNITY
TEST LEVEL, the distance between the transmit-
ting antenna and the ME EQUIPMENT or ME
SYSTEM may be reduced to 1 m. The 1 m test
distance is permitted by IEC 61000-4-3.
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.
Compliance
level
±8 kV contact
±15 kV air
30A/m
50Hz or 60Hz
10 V/m
80 MHz to 2.7 GHz
80% AM at 1kHz
Table 2-Compliance information for Immunity test
Table 1-Compliance information for Emission test
Phenomenon
ELECTROSTATIC
DISCHARGE
IEC 61000-4-2
RATED power
frequency
magnetic fields
IEC 61000-4-8
Radiated RF EM fields
IEC 61000-4-3
Emission test
Compliance
Group 1
RF emissions
CISPR 11
RF emissions
CISPR 11
Class B
Electromagnetic Compatibility (EMC) compliance
1.This device has been tested and complies with the
Class B limits for medical devices according to the
IEC 60601-1-2.
2.The thermometer is suitable for both professional
and home use, except near active HF SURGICAL
EQUIPMENT or in RF shielded magnetic resonance
imaging (MRI) rooms.
3.The thermometer measure ranges between 34.0
42.2℃ (93.2℉‒108.0). Accuracy is ±0.2℃
(±0.4) within 35.0℃ 42.0℃ (95.0℉‒107.6),
±0.3℃ (±0.5) beyond this range. When using the
device near strong electromagnetic interference
(e.g., cell phones, microwaves, etc.), it may
temporarily affect accuracy. Please keep the device
away if necessary.
4.WARNING: Do not place the thermometer near or
stack it with other medical devices to avoid potential-
ly inaccurate measurements.
5.WARNING: Portable RF communications
equipment (including peripherals such as antenna
cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the
thermometer. Otherwise, degradation of the
performance of the thermometer could result.
Table 1. Electromagnetic emissions
12. After-sales Service
11. Replacing The Batteries
1.The state of the internal electrical power source
will display a different icon depending on the battery
capacity. When the screen only displays the symbol
" " , prompt to replace the battery as soon as
possible; when the symbol " " is displayed,
replace the battery immediately. Replace with 2 new
AAA batteries, slide open the battery cover and
remove old batteries. Replace the batteries being
sure to align properly as indicated inside the battery
compartment.
2.Remove the battery from the product if it is not
required for extended periods of time in order to
avoid damage to the thermometer resulting from a
leaking battery.
3.To protect the environment, dispose of empty
batteries at appropriate collection sites according to
national or local regulations.
1.The thermometer is calibrated initially when
manufactured. There is no need for readjustment if it
is used according to the instruction. If at anytime you
question the accuracy of the temperature measure-
ment, please contact the manufacturer.
Adjusted mode is for general public and calibration
mode is for after-sale person only.
2.This product provides free maintenance service
for one year. If you need to provide circuit diagram,
necessary materials and maintenance of electrical
circuit for any problem, please contact the
manufacturer.
3. No free warranty service will be provided for the
faults caused by the following use:
1) Failure caused by unauthorized disassembly and
modification of products.
2) Failure caused by product drop.
3) Failure caused by failure to operate according to
the instructions.
4) Failure caused by lack of reasonable mainte-
nance.
5) Damage caused by external force.
4. This product will not cause allergic reaction and
harm to human body during normal use.
5.If the situations cannot be solved or unexpected
problem happens, please consult the local distributor.
6.Any serious incident that has occurred in relation
to the device please report to the manufacturer and
the competent authority of the Member State.
14. Connect To HealthCare+
For details, please refer to the APP Quick Guide.
1.To ensure that the measurement results can be
transmitted through Bluetooth, please keep the
distance between the device and the mobile phone
no more than 10 meters.
2.If you want your body temperature measurements
to be sent to your phone via Bluetooth, get a phone
that supports Android 5.0 and above or IOS 10.0 and
above to download Yuwell HealthCare+.
REFERENCE BODY SITE Oral measurement
CLINICAL
BIAS(
Δcb)
LIMITS OF
AGREEMENT
(LA
CLINICAL
REPEATABI
-LITY(
σr
)
Measuring site of
infrared thermometer
Forehead
Less than
1 year of age
-0.09℃
0.62℃
0.13℃
Aged
1-5 years
-0.17℃
0.95℃
0.21℃
Older than
5 years
-0.10℃
0.95℃
0.22℃
Revision date: Mar. 2026
YHW-5/YHW-6
Infrared Thermometer
User Manual And Technical Instruction
Service life: 5 years. Please read the user manual carefully and
follow the instructions before use. For date of manufacture, please
refer to the packaging.
The picture is for reference only, please refer to the actual product.
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO.,LTD.
No.1 Baisheng Road Development Zone, Danyang,
Jiangsu 212300 CHINA
www.yuwell.com
The normal body temperature of people is a range,
different people's normal body temperature varies,
and individual body temperature will change at
different times.
The normal body temperature of most people is
provided as follows, just for reference.
Axillary temperature:
36.0℃~37.4℃/96.8~99.32
Oral temperature:
36.3℃~37.2℃/97.34~98.96
Rectal temperature:
36.9℃~37.9℃/98.42~100.22
16. Cybersecurity
1.Cybersecurity Controls and Product Specification
Description
(1) The device and the App communicate via
Bluetooth, ensuring secure communication through
a private protocol.
(2) Please ensure that your network environment
has installed and updated firewall and antivirus
software to protect against malicious software and
virus intrusions.
2. Detailed Cybersecurity Implementation Diagram
3. Network Interface and Port Description
4. Support Infrastructure Requirements
(1) Users should only pair the device with their
mobile phones in a secure and trusted environment;
for example:
●Encrypted broadband networks
●Dedicated network lines
●WIFIPersonal portable Wi-Fi
(2) Place the device as far away as possible from
other electronic devices that may cause interfer-
ence. For instance, maintain a certain distance from
other Bluetooth devices, Wi-Fi routers, and
microwave ovens.
(3) It is recommended that users protect their mobile
phones to prevent unauthorized access to personal
data by:
●Setting an automatic keyboard lock on the phone
to prevent unauthorized use;
●Configuring a personal device PIN or password to
unlock the keyboard;
●Installing security protection software on the
phone to guard against viruses, trojans, and other
Infrared
thermom-
eter
Yuwell
HeaithCare+
app
Trust boundary
Date transfer by
Bluetooth
Interface
Interface
functionality
Attribute
Approved
Destination
End-points
Bluetooth
Transmit measured
body temperature values
Outgoing
Yuwell
HealthCare+ application
intrusions.
(4) Please do not install or use the APP on rooted or
jailbroken devices.
5.Software Bill of Materials (SBOM): An international
standard Software Bill of Materials (SBOM) in SPDX
format has been generated, supporting conversion to
other international and industry-standard SBOM
formats such as CycloneDX and SWID. If required,
users can send an email to request the latest SBOM
list.
6. Software and Firmware Download
(1) The App is distributed exclusively through the
Google Play Store and Apple Store. Downloading
software updates from unauthorized channels
increases the risk of cybersecurity vulnerabilities.
Our company bears no responsibility for any
consequences that may arise from such actions.
(2) Users should regularly check and perform
available updates for the APP software to promptly
address potential security vulnerabilities.
7. Security Event Response Design
The device operates fully localized, without commu-
nication to the cloud, and does not handle sensitive
personal data. Data transmission is based on
Bluetooth protocol.
8. Critical Function Protection
The device operates fully localized without network-
ing. Its core functions remain unaffected even if the
device is partially damaged and unusable.
9. Backup and Restore Features
No such function
10. Retention and Recovery of Device Configura-
tion
The device operates fully offline and uses
Bluetooth for communication. There is no risk of
network-based attacks (e.g., DDoS attacks, etc.),
and neither the device nor the app requires security
configurations.
11. Secure configuration of device
The device and app do not have security configura-
tions. Bluetooth communication is used, and the
manufacturer has closed all service ports to prevent
attacks, as confirmed by security testing.
12. Capture of Forensic Evidence
The app does not generate log files because internet
connectivity is absent to transmit log files.
13. Information Concerning Device Cybersecurity
End of Support and End of Life
During the valid service period of the device, our
company will provide continuous tracking and repair
of any security issues that exist with the device. If the
device exceeds its service life, our company cannot
guarantee reasonable software update services for
users. Continued use of the device after support has
ended may pose certain security risks to users, and
it is recommended that users discontinue use of the
device.
14.Information on Securely Decommissioning
Devices
The device does not contain sensitive, confidential,
or proprietary data or software; users can delete all
measurement data on the device and in the app.
Supplier's Declaration of Conformity
47 CFR § 2.1077 Compliance Information
Trade Name:
Product name: Infrared thermometer
Model Number: YHW-6
Responsible party: YUWELL MEDTECH USA LLC
Address: 2152 Serene Ct, Keller, TX 76248
Contact information
Name: Fang Zhang
Telephone number: (206) 639-1311
E-mail address: [email protected]
FCC Compliance Statement
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.
background
11 13 14 15 16 17 1812
10. Temperature Sense
YY-THM0015D-01(A/0)
13. Warranty Card
Warranty card
Product name:
Infrared thermometer
Model:
YHW-5/YHW-6
Table 3-Test specifications for ENCLOSURE PORT
IMMUNITY to RF wireless communications equipment
15. Guidance and Manufacturers Declaration
on EMC
1700-1990
2400-2570
GSM 1800;
CMDA 1900;
GSM 1900;
DECT;
LTE Band 1,3,
4,25; UMTS
Bluetooth,
WLAN,
802.11 b/g/n
RFID 2450,
LTE Band 7
1720
1845
1970
2450
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
217 Hz
Test
frequency
(MHz)
Band
a)
(MHz)
Service
a)
Modulation
b)
704-787
450
385
800-960
380-390
430-470
TETRA 400
GMRS 460,
FRS 460
LTE Band
13,17
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
710
745
780
810
870
930
Pulse
modulation
b)
18 Hz
FM
c)
±5 kHz
deviation
1 kHz sine
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
18 Hz
Test
frequency
(MHz)
IMMUNITY
TEST LEVEL
(V/m)
450
385
5240
5500
5785
710
745
780
810
870
930
1720
1845
1970
2450
5240
5500
5785
Pulse
modulation
b)
217 Hz
Maximum
power
(W)
5100-5800
1,8
2
Distance
(m)
WLAN 802.11
a/n
0,3
0,3
27
28
0,2
2
2
0,2
2
0,3
0,3
0,3
0,3
0,3
9
28
28
9
28
NOTE If necessary to achieve the IMMUNITY
TEST LEVEL, the distance between the transmit-
ting antenna and the ME EQUIPMENT or ME
SYSTEM may be reduced to 1 m. The 1 m test
distance is permitted by IEC 61000-4-3.
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.
Compliance
level
±8 kV contact
±15 kV air
30A/m
50Hz or 60Hz
10 V/m
80 MHz to 2.7 GHz
80% AM at 1kHz
Table 2-Compliance information for Immunity test
Table 1-Compliance information for Emission test
Phenomenon
ELECTROSTATIC
DISCHARGE
IEC 61000-4-2
RATED power
frequency
magnetic fields
IEC 61000-4-8
Radiated RF EM fields
IEC 61000-4-3
Emission test
Compliance
Group 1
RF emissions
CISPR 11
RF emissions
CISPR 11
Class B
Electromagnetic Compatibility (EMC) compliance
1.This device has been tested and complies with the
Class B limits for medical devices according to the
IEC 60601-1-2.
2.The thermometer is suitable for both professional
and home use, except near active HF SURGICAL
EQUIPMENT or in RF shielded magnetic resonance
imaging (MRI) rooms.
3.The thermometer measure ranges between 34.0
42.2℃ (93.2℉‒108.0). Accuracy is ±0.2℃
(±0.4) within 35.0℃ 42.0℃ (95.0℉‒107.6),
±0.3℃ (±0.5) beyond this range. When using the
device near strong electromagnetic interference
(e.g., cell phones, microwaves, etc.), it may
temporarily affect accuracy. Please keep the device
away if necessary.
4.WARNING: Do not place the thermometer near or
stack it with other medical devices to avoid potential-
ly inaccurate measurements.
5.WARNING: Portable RF communications
equipment (including peripherals such as antenna
cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the
thermometer. Otherwise, degradation of the
performance of the thermometer could result.
Table 1. Electromagnetic emissions
12. After-sales Service
11. Replacing The Batteries
1.The state of the internal electrical power source
will display a different icon depending on the battery
capacity. When the screen only displays the symbol
" " , prompt to replace the battery as soon as
possible; when the symbol " " is displayed,
replace the battery immediately. Replace with 2 new
AAA batteries, slide open the battery cover and
remove old batteries. Replace the batteries being
sure to align properly as indicated inside the battery
compartment.
2.Remove the battery from the product if it is not
required for extended periods of time in order to
avoid damage to the thermometer resulting from a
leaking battery.
3.To protect the environment, dispose of empty
batteries at appropriate collection sites according to
national or local regulations.
1.The thermometer is calibrated initially when
manufactured. There is no need for readjustment if it
is used according to the instruction. If at anytime you
question the accuracy of the temperature measure-
ment, please contact the manufacturer.
Adjusted mode is for general public and calibration
mode is for after-sale person only.
2.This product provides free maintenance service
for one year. If you need to provide circuit diagram,
necessary materials and maintenance of electrical
circuit for any problem, please contact the
manufacturer.
3. No free warranty service will be provided for the
faults caused by the following use:
1) Failure caused by unauthorized disassembly and
modification of products.
2) Failure caused by product drop.
3) Failure caused by failure to operate according to
the instructions.
4) Failure caused by lack of reasonable mainte-
nance.
5) Damage caused by external force.
4. This product will not cause allergic reaction and
harm to human body during normal use.
5.If the situations cannot be solved or unexpected
problem happens, please consult the local distributor.
6.Any serious incident that has occurred in relation
to the device please report to the manufacturer and
the competent authority of the Member State.
14. Connect To HealthCare+
For details, please refer to the APP Quick Guide.
1.To ensure that the measurement results can be
transmitted through Bluetooth, please keep the
distance between the device and the mobile phone
no more than 10 meters.
2.If you want your body temperature measurements
to be sent to your phone via Bluetooth, get a phone
that supports Android 5.0 and above or IOS 10.0 and
above to download Yuwell HealthCare+.
REFERENCE BODY SITE Oral measurement
CLINICAL
BIAS(
Δcb)
LIMITS OF
AGREEMENT
(LA
CLINICAL
REPEATABI
-LITY(
σr
)
Measuring site of
infrared thermometer
Forehead
Less than
1 year of age
-0.09℃
0.62℃
0.13℃
Aged
1-5 years
-0.17℃
0.95℃
0.21℃
Older than
5 years
-0.10℃
0.95℃
0.22℃
Revision date: Mar. 2026
YHW-5/YHW-6
Infrared Thermometer
User Manual And Technical Instruction
Service life: 5 years. Please read the user manual carefully and
follow the instructions before use. For date of manufacture, please
refer to the packaging.
The picture is for reference only, please refer to the actual product.
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO.,LTD.
No.1 Baisheng Road Development Zone, Danyang,
Jiangsu 212300 CHINA
www.yuwell.com
The normal body temperature of people is a range,
different people's normal body temperature varies,
and individual body temperature will change at
different times.
The normal body temperature of most people is
provided as follows, just for reference.
Axillary temperature:
36.0℃~37.4℃/96.8~99.32
Oral temperature:
36.3℃~37.2℃/97.34~98.96
Rectal temperature:
36.9℃~37.9℃/98.42~100.22
16. Cybersecurity
1.Cybersecurity Controls and Product Specification
Description
(1) The device and the App communicate via
Bluetooth, ensuring secure communication through
a private protocol.
(2) Please ensure that your network environment
has installed and updated firewall and antivirus
software to protect against malicious software and
virus intrusions.
2. Detailed Cybersecurity Implementation Diagram
3. Network Interface and Port Description
4. Support Infrastructure Requirements
(1) Users should only pair the device with their
mobile phones in a secure and trusted environment;
for example:
●Encrypted broadband networks
●Dedicated network lines
●WIFIPersonal portable Wi-Fi
(2) Place the device as far away as possible from
other electronic devices that may cause interfer-
ence. For instance, maintain a certain distance from
other Bluetooth devices, Wi-Fi routers, and
microwave ovens.
(3) It is recommended that users protect their mobile
phones to prevent unauthorized access to personal
data by:
●Setting an automatic keyboard lock on the phone
to prevent unauthorized use;
●Configuring a personal device PIN or password to
unlock the keyboard;
●Installing security protection software on the
phone to guard against viruses, trojans, and other
Infrared
thermom-
eter
Yuwell
HeaithCare+
app
Trust boundary
Date transfer by
Bluetooth
Interface
Interface
functionality
Attribute
Approved
Destination
End-points
Bluetooth
Transmit measured
body temperature values
Outgoing
Yuwell
HealthCare+ application
intrusions.
(4) Please do not install or use the APP on rooted or
jailbroken devices.
5.Software Bill of Materials (SBOM): An international
standard Software Bill of Materials (SBOM) in SPDX
format has been generated, supporting conversion to
other international and industry-standard SBOM
formats such as CycloneDX and SWID. If required,
users can send an email to request the latest SBOM
list.
6. Software and Firmware Download
(1) The App is distributed exclusively through the
Google Play Store and Apple Store. Downloading
software updates from unauthorized channels
increases the risk of cybersecurity vulnerabilities.
Our company bears no responsibility for any
consequences that may arise from such actions.
(2) Users should regularly check and perform
available updates for the APP software to promptly
address potential security vulnerabilities.
7. Security Event Response Design
The device operates fully localized, without commu-
nication to the cloud, and does not handle sensitive
personal data. Data transmission is based on
Bluetooth protocol.
8. Critical Function Protection
The device operates fully localized without network-
ing. Its core functions remain unaffected even if the
device is partially damaged and unusable.
9. Backup and Restore Features
No such function
10. Retention and Recovery of Device Configura-
tion
The device operates fully offline and uses
Bluetooth for communication. There is no risk of
network-based attacks (e.g., DDoS attacks, etc.),
and neither the device nor the app requires security
configurations.
11. Secure configuration of device
The device and app do not have security configura-
tions. Bluetooth communication is used, and the
manufacturer has closed all service ports to prevent
attacks, as confirmed by security testing.
12. Capture of Forensic Evidence
The app does not generate log files because internet
connectivity is absent to transmit log files.
13. Information Concerning Device Cybersecurity
End of Support and End of Life
During the valid service period of the device, our
company will provide continuous tracking and repair
of any security issues that exist with the device. If the
device exceeds its service life, our company cannot
guarantee reasonable software update services for
users. Continued use of the device after support has
ended may pose certain security risks to users, and
it is recommended that users discontinue use of the
device.
14.Information on Securely Decommissioning
Devices
The device does not contain sensitive, confidential,
or proprietary data or software; users can delete all
measurement data on the device and in the app.
Supplier's Declaration of Conformity
47 CFR § 2.1077 Compliance Information
Trade Name:
Product name: Infrared thermometer
Model Number: YHW-6
Responsible party: YUWELL MEDTECH USA LLC
Address: 2152 Serene Ct, Keller, TX 76248
Contact information
Name: Fang Zhang
Telephone number: (206) 639-1311
E-mail address: [email protected]
FCC Compliance Statement
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.
background
11 13 14 15 16 17 1812
10. Temperature Sense
YY-THM0015D-01(A/0)
13. Warranty Card
Warranty card
Product name:
Infrared thermometer
Model:
YHW-5/YHW-6
Table 3-Test specifications for ENCLOSURE PORT
IMMUNITY to RF wireless communications equipment
15. Guidance and Manufacturers Declaration
on EMC
1700-1990
2400-2570
GSM 1800;
CMDA 1900;
GSM 1900;
DECT;
LTE Band 1,3,
4,25; UMTS
Bluetooth,
WLAN,
802.11 b/g/n
RFID 2450,
LTE Band 7
1720
1845
1970
2450
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
217 Hz
Test
frequency
(MHz)
Band
a)
(MHz)
Service
a)
Modulation
b)
704-787
450
385
800-960
380-390
430-470
TETRA 400
GMRS 460,
FRS 460
LTE Band
13,17
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
710
745
780
810
870
930
Pulse
modulation
b)
18 Hz
FM
c)
±5 kHz
deviation
1 kHz sine
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
18 Hz
Test
frequency
(MHz)
IMMUNITY
TEST LEVEL
(V/m)
450
385
5240
5500
5785
710
745
780
810
870
930
1720
1845
1970
2450
5240
5500
5785
Pulse
modulation
b)
217 Hz
Maximum
power
(W)
5100-5800
1,8
2
Distance
(m)
WLAN 802.11
a/n
0,3
0,3
27
28
0,2
2
2
0,2
2
0,3
0,3
0,3
0,3
0,3
9
28
28
9
28
NOTE If necessary to achieve the IMMUNITY
TEST LEVEL, the distance between the transmit-
ting antenna and the ME EQUIPMENT or ME
SYSTEM may be reduced to 1 m. The 1 m test
distance is permitted by IEC 61000-4-3.
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.
Compliance
level
±8 kV contact
±15 kV air
30A/m
50Hz or 60Hz
10 V/m
80 MHz to 2.7 GHz
80% AM at 1kHz
Table 2-Compliance information for Immunity test
Table 1-Compliance information for Emission test
Phenomenon
ELECTROSTATIC
DISCHARGE
IEC 61000-4-2
RATED power
frequency
magnetic fields
IEC 61000-4-8
Radiated RF EM fields
IEC 61000-4-3
Emission test
Compliance
Group 1
RF emissions
CISPR 11
RF emissions
CISPR 11
Class B
Electromagnetic Compatibility (EMC) compliance
1.This device has been tested and complies with the
Class B limits for medical devices according to the
IEC 60601-1-2.
2.The thermometer is suitable for both professional
and home use, except near active HF SURGICAL
EQUIPMENT or in RF shielded magnetic resonance
imaging (MRI) rooms.
3.The thermometer measure ranges between 34.0
42.2℃ (93.2℉‒108.0). Accuracy is ±0.2℃
(±0.4) within 35.0℃ 42.0℃ (95.0℉‒107.6),
±0.3℃ (±0.5) beyond this range. When using the
device near strong electromagnetic interference
(e.g., cell phones, microwaves, etc.), it may
temporarily affect accuracy. Please keep the device
away if necessary.
4.WARNING: Do not place the thermometer near or
stack it with other medical devices to avoid potential-
ly inaccurate measurements.
5.WARNING: Portable RF communications
equipment (including peripherals such as antenna
cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the
thermometer. Otherwise, degradation of the
performance of the thermometer could result.
Table 1. Electromagnetic emissions
12. After-sales Service
11. Replacing The Batteries
1.The state of the internal electrical power source
will display a different icon depending on the battery
capacity. When the screen only displays the symbol
" " , prompt to replace the battery as soon as
possible; when the symbol " " is displayed,
replace the battery immediately. Replace with 2 new
AAA batteries, slide open the battery cover and
remove old batteries. Replace the batteries being
sure to align properly as indicated inside the battery
compartment.
2.Remove the battery from the product if it is not
required for extended periods of time in order to
avoid damage to the thermometer resulting from a
leaking battery.
3.To protect the environment, dispose of empty
batteries at appropriate collection sites according to
national or local regulations.
1.The thermometer is calibrated initially when
manufactured. There is no need for readjustment if it
is used according to the instruction. If at anytime you
question the accuracy of the temperature measure-
ment, please contact the manufacturer.
Adjusted mode is for general public and calibration
mode is for after-sale person only.
2.This product provides free maintenance service
for one year. If you need to provide circuit diagram,
necessary materials and maintenance of electrical
circuit for any problem, please contact the
manufacturer.
3. No free warranty service will be provided for the
faults caused by the following use:
1) Failure caused by unauthorized disassembly and
modification of products.
2) Failure caused by product drop.
3) Failure caused by failure to operate according to
the instructions.
4) Failure caused by lack of reasonable mainte-
nance.
5) Damage caused by external force.
4. This product will not cause allergic reaction and
harm to human body during normal use.
5.If the situations cannot be solved or unexpected
problem happens, please consult the local distributor.
6.Any serious incident that has occurred in relation
to the device please report to the manufacturer and
the competent authority of the Member State.
14. Connect To HealthCare+
For details, please refer to the APP Quick Guide.
1.To ensure that the measurement results can be
transmitted through Bluetooth, please keep the
distance between the device and the mobile phone
no more than 10 meters.
2.If you want your body temperature measurements
to be sent to your phone via Bluetooth, get a phone
that supports Android 5.0 and above or IOS 10.0 and
above to download Yuwell HealthCare+.
REFERENCE BODY SITE Oral measurement
CLINICAL
BIAS(
Δcb)
LIMITS OF
AGREEMENT
(LA
CLINICAL
REPEATABI
-LITY(
σr
)
Measuring site of
infrared thermometer
Forehead
Less than
1 year of age
-0.09℃
0.62℃
0.13℃
Aged
1-5 years
-0.17℃
0.95℃
0.21℃
Older than
5 years
-0.10℃
0.95℃
0.22℃
Revision date: Mar. 2026
YHW-5/YHW-6
Infrared Thermometer
User Manual And Technical Instruction
Service life: 5 years. Please read the user manual carefully and
follow the instructions before use. For date of manufacture, please
refer to the packaging.
The picture is for reference only, please refer to the actual product.
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO.,LTD.
No.1 Baisheng Road Development Zone, Danyang,
Jiangsu 212300 CHINA
www.yuwell.com
The normal body temperature of people is a range,
different people's normal body temperature varies,
and individual body temperature will change at
different times.
The normal body temperature of most people is
provided as follows, just for reference.
Axillary temperature:
36.0℃~37.4℃/96.8~99.32
Oral temperature:
36.3℃~37.2℃/97.34~98.96
Rectal temperature:
36.9℃~37.9℃/98.42~100.22
16. Cybersecurity
1.Cybersecurity Controls and Product Specification
Description
(1) The device and the App communicate via
Bluetooth, ensuring secure communication through
a private protocol.
(2) Please ensure that your network environment
has installed and updated firewall and antivirus
software to protect against malicious software and
virus intrusions.
2. Detailed Cybersecurity Implementation Diagram
3. Network Interface and Port Description
4. Support Infrastructure Requirements
(1) Users should only pair the device with their
mobile phones in a secure and trusted environment;
for example:
●Encrypted broadband networks
●Dedicated network lines
●WIFIPersonal portable Wi-Fi
(2) Place the device as far away as possible from
other electronic devices that may cause interfer-
ence. For instance, maintain a certain distance from
other Bluetooth devices, Wi-Fi routers, and
microwave ovens.
(3) It is recommended that users protect their mobile
phones to prevent unauthorized access to personal
data by:
●Setting an automatic keyboard lock on the phone
to prevent unauthorized use;
●Configuring a personal device PIN or password to
unlock the keyboard;
●Installing security protection software on the
phone to guard against viruses, trojans, and other
Infrared
thermom-
eter
Yuwell
HeaithCare+
app
Trust boundary
Date transfer by
Bluetooth
Interface
Interface
functionality
Attribute
Approved
Destination
End-points
Bluetooth
Transmit measured
body temperature values
Outgoing
Yuwell
HealthCare+ application
intrusions.
(4) Please do not install or use the APP on rooted or
jailbroken devices.
5.Software Bill of Materials (SBOM): An international
standard Software Bill of Materials (SBOM) in SPDX
format has been generated, supporting conversion to
other international and industry-standard SBOM
formats such as CycloneDX and SWID. If required,
users can send an email to request the latest SBOM
list.
6. Software and Firmware Download
(1) The App is distributed exclusively through the
Google Play Store and Apple Store. Downloading
software updates from unauthorized channels
increases the risk of cybersecurity vulnerabilities.
Our company bears no responsibility for any
consequences that may arise from such actions.
(2) Users should regularly check and perform
available updates for the APP software to promptly
address potential security vulnerabilities.
7. Security Event Response Design
The device operates fully localized, without commu-
nication to the cloud, and does not handle sensitive
personal data. Data transmission is based on
Bluetooth protocol.
8. Critical Function Protection
The device operates fully localized without network-
ing. Its core functions remain unaffected even if the
device is partially damaged and unusable.
9. Backup and Restore Features
No such function
10. Retention and Recovery of Device Configura-
tion
The device operates fully offline and uses
Bluetooth for communication. There is no risk of
network-based attacks (e.g., DDoS attacks, etc.),
and neither the device nor the app requires security
configurations.
11. Secure configuration of device
The device and app do not have security configura-
tions. Bluetooth communication is used, and the
manufacturer has closed all service ports to prevent
attacks, as confirmed by security testing.
12. Capture of Forensic Evidence
The app does not generate log files because internet
connectivity is absent to transmit log files.
13. Information Concerning Device Cybersecurity
End of Support and End of Life
During the valid service period of the device, our
company will provide continuous tracking and repair
of any security issues that exist with the device. If the
device exceeds its service life, our company cannot
guarantee reasonable software update services for
users. Continued use of the device after support has
ended may pose certain security risks to users, and
it is recommended that users discontinue use of the
device.
14.Information on Securely Decommissioning
Devices
The device does not contain sensitive, confidential,
or proprietary data or software; users can delete all
measurement data on the device and in the app.
Supplier's Declaration of Conformity
47 CFR § 2.1077 Compliance Information
Trade Name:
Product name: Infrared thermometer
Model Number: YHW-6
Responsible party: YUWELL MEDTECH USA LLC
Address: 2152 Serene Ct, Keller, TX 76248
Contact information
Name: Fang Zhang
Telephone number: (206) 639-1311
E-mail address: [email protected]
FCC Compliance Statement
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.
background
11 13 14 15 16 17 1812
10. Temperature Sense
YY-THM0015D-01(A/0)
13. Warranty Card
Warranty card
Product name:
Infrared thermometer
Model:
YHW-5/YHW-6
Table 3-Test specifications for ENCLOSURE PORT
IMMUNITY to RF wireless communications equipment
15. Guidance and Manufacturers Declaration
on EMC
1700-1990
2400-2570
GSM 1800;
CMDA 1900;
GSM 1900;
DECT;
LTE Band 1,3,
4,25; UMTS
Bluetooth,
WLAN,
802.11 b/g/n
RFID 2450,
LTE Band 7
1720
1845
1970
2450
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
217 Hz
Test
frequency
(MHz)
Band
a)
(MHz)
Service
a)
Modulation
b)
704-787
450
385
800-960
380-390
430-470
TETRA 400
GMRS 460,
FRS 460
LTE Band
13,17
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
710
745
780
810
870
930
Pulse
modulation
b)
18 Hz
FM
c)
±5 kHz
deviation
1 kHz sine
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
18 Hz
Test
frequency
(MHz)
IMMUNITY
TEST LEVEL
(V/m)
450
385
5240
5500
5785
710
745
780
810
870
930
1720
1845
1970
2450
5240
5500
5785
Pulse
modulation
b)
217 Hz
Maximum
power
(W)
5100-5800
1,8
2
Distance
(m)
WLAN 802.11
a/n
0,3
0,3
27
28
0,2
2
2
0,2
2
0,3
0,3
0,3
0,3
0,3
9
28
28
9
28
NOTE If necessary to achieve the IMMUNITY
TEST LEVEL, the distance between the transmit-
ting antenna and the ME EQUIPMENT or ME
SYSTEM may be reduced to 1 m. The 1 m test
distance is permitted by IEC 61000-4-3.
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.
Compliance
level
±8 kV contact
±15 kV air
30A/m
50Hz or 60Hz
10 V/m
80 MHz to 2.7 GHz
80% AM at 1kHz
Table 2-Compliance information for Immunity test
Table 1-Compliance information for Emission test
Phenomenon
ELECTROSTATIC
DISCHARGE
IEC 61000-4-2
RATED power
frequency
magnetic fields
IEC 61000-4-8
Radiated RF EM fields
IEC 61000-4-3
Emission test
Compliance
Group 1
RF emissions
CISPR 11
RF emissions
CISPR 11
Class B
Electromagnetic Compatibility (EMC) compliance
1.This device has been tested and complies with the
Class B limits for medical devices according to the
IEC 60601-1-2.
2.The thermometer is suitable for both professional
and home use, except near active HF SURGICAL
EQUIPMENT or in RF shielded magnetic resonance
imaging (MRI) rooms.
3.The thermometer measure ranges between 34.0
42.2℃ (93.2℉‒108.0). Accuracy is ±0.2℃
(±0.4) within 35.0℃ 42.0℃ (95.0℉‒107.6),
±0.3℃ (±0.5) beyond this range. When using the
device near strong electromagnetic interference
(e.g., cell phones, microwaves, etc.), it may
temporarily affect accuracy. Please keep the device
away if necessary.
4.WARNING: Do not place the thermometer near or
stack it with other medical devices to avoid potential-
ly inaccurate measurements.
5.WARNING: Portable RF communications
equipment (including peripherals such as antenna
cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the
thermometer. Otherwise, degradation of the
performance of the thermometer could result.
Table 1. Electromagnetic emissions
12. After-sales Service
11. Replacing The Batteries
1.The state of the internal electrical power source
will display a different icon depending on the battery
capacity. When the screen only displays the symbol
" " , prompt to replace the battery as soon as
possible; when the symbol " " is displayed,
replace the battery immediately. Replace with 2 new
AAA batteries, slide open the battery cover and
remove old batteries. Replace the batteries being
sure to align properly as indicated inside the battery
compartment.
2.Remove the battery from the product if it is not
required for extended periods of time in order to
avoid damage to the thermometer resulting from a
leaking battery.
3.To protect the environment, dispose of empty
batteries at appropriate collection sites according to
national or local regulations.
1.The thermometer is calibrated initially when
manufactured. There is no need for readjustment if it
is used according to the instruction. If at anytime you
question the accuracy of the temperature measure-
ment, please contact the manufacturer.
Adjusted mode is for general public and calibration
mode is for after-sale person only.
2.This product provides free maintenance service
for one year. If you need to provide circuit diagram,
necessary materials and maintenance of electrical
circuit for any problem, please contact the
manufacturer.
3. No free warranty service will be provided for the
faults caused by the following use:
1) Failure caused by unauthorized disassembly and
modification of products.
2) Failure caused by product drop.
3) Failure caused by failure to operate according to
the instructions.
4) Failure caused by lack of reasonable mainte-
nance.
5) Damage caused by external force.
4. This product will not cause allergic reaction and
harm to human body during normal use.
5.If the situations cannot be solved or unexpected
problem happens, please consult the local distributor.
6.Any serious incident that has occurred in relation
to the device please report to the manufacturer and
the competent authority of the Member State.
14. Connect To HealthCare+
For details, please refer to the APP Quick Guide.
1.To ensure that the measurement results can be
transmitted through Bluetooth, please keep the
distance between the device and the mobile phone
no more than 10 meters.
2.If you want your body temperature measurements
to be sent to your phone via Bluetooth, get a phone
that supports Android 5.0 and above or IOS 10.0 and
above to download Yuwell HealthCare+.
REFERENCE BODY SITE Oral measurement
CLINICAL
BIAS(
Δcb)
LIMITS OF
AGREEMENT
(LA
CLINICAL
REPEATABI
-LITY(
σr
)
Measuring site of
infrared thermometer
Forehead
Less than
1 year of age
-0.09℃
0.62℃
0.13℃
Aged
1-5 years
-0.17℃
0.95℃
0.21℃
Older than
5 years
-0.10℃
0.95℃
0.22℃
Revision date: Mar. 2026
YHW-5/YHW-6
Infrared Thermometer
User Manual And Technical Instruction
Service life: 5 years. Please read the user manual carefully and
follow the instructions before use. For date of manufacture, please
refer to the packaging.
The picture is for reference only, please refer to the actual product.
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO.,LTD.
No.1 Baisheng Road Development Zone, Danyang,
Jiangsu 212300 CHINA
www.yuwell.com
The normal body temperature of people is a range,
different people's normal body temperature varies,
and individual body temperature will change at
different times.
The normal body temperature of most people is
provided as follows, just for reference.
Axillary temperature:
36.0℃~37.4℃/96.8~99.32
Oral temperature:
36.3℃~37.2℃/97.34~98.96
Rectal temperature:
36.9℃~37.9℃/98.42~100.22
16. Cybersecurity
1.Cybersecurity Controls and Product Specification
Description
(1) The device and the App communicate via
Bluetooth, ensuring secure communication through
a private protocol.
(2) Please ensure that your network environment
has installed and updated firewall and antivirus
software to protect against malicious software and
virus intrusions.
2. Detailed Cybersecurity Implementation Diagram
3. Network Interface and Port Description
4. Support Infrastructure Requirements
(1) Users should only pair the device with their
mobile phones in a secure and trusted environment;
for example:
●Encrypted broadband networks
●Dedicated network lines
●WIFIPersonal portable Wi-Fi
(2) Place the device as far away as possible from
other electronic devices that may cause interfer-
ence. For instance, maintain a certain distance from
other Bluetooth devices, Wi-Fi routers, and
microwave ovens.
(3) It is recommended that users protect their mobile
phones to prevent unauthorized access to personal
data by:
●Setting an automatic keyboard lock on the phone
to prevent unauthorized use;
●Configuring a personal device PIN or password to
unlock the keyboard;
●Installing security protection software on the
phone to guard against viruses, trojans, and other
Infrared
thermom-
eter
Yuwell
HeaithCare+
app
Trust boundary
Date transfer by
Bluetooth
Interface
Interface
functionality
Attribute
Approved
Destination
End-points
Bluetooth
Transmit measured
body temperature values
Outgoing
Yuwell
HealthCare+ application
intrusions.
(4) Please do not install or use the APP on rooted or
jailbroken devices.
5.Software Bill of Materials (SBOM): An international
standard Software Bill of Materials (SBOM) in SPDX
format has been generated, supporting conversion to
other international and industry-standard SBOM
formats such as CycloneDX and SWID. If required,
users can send an email to request the latest SBOM
list.
6. Software and Firmware Download
(1) The App is distributed exclusively through the
Google Play Store and Apple Store. Downloading
software updates from unauthorized channels
increases the risk of cybersecurity vulnerabilities.
Our company bears no responsibility for any
consequences that may arise from such actions.
(2) Users should regularly check and perform
available updates for the APP software to promptly
address potential security vulnerabilities.
7. Security Event Response Design
The device operates fully localized, without commu-
nication to the cloud, and does not handle sensitive
personal data. Data transmission is based on
Bluetooth protocol.
8. Critical Function Protection
The device operates fully localized without network-
ing. Its core functions remain unaffected even if the
device is partially damaged and unusable.
9. Backup and Restore Features
No such function
10. Retention and Recovery of Device Configura-
tion
The device operates fully offline and uses
Bluetooth for communication. There is no risk of
network-based attacks (e.g., DDoS attacks, etc.),
and neither the device nor the app requires security
configurations.
11. Secure configuration of device
The device and app do not have security configura-
tions. Bluetooth communication is used, and the
manufacturer has closed all service ports to prevent
attacks, as confirmed by security testing.
12. Capture of Forensic Evidence
The app does not generate log files because internet
connectivity is absent to transmit log files.
13. Information Concerning Device Cybersecurity
End of Support and End of Life
During the valid service period of the device, our
company will provide continuous tracking and repair
of any security issues that exist with the device. If the
device exceeds its service life, our company cannot
guarantee reasonable software update services for
users. Continued use of the device after support has
ended may pose certain security risks to users, and
it is recommended that users discontinue use of the
device.
14.Information on Securely Decommissioning
Devices
The device does not contain sensitive, confidential,
or proprietary data or software; users can delete all
measurement data on the device and in the app.
Supplier's Declaration of Conformity
47 CFR § 2.1077 Compliance Information
Trade Name:
Product name: Infrared thermometer
Model Number: YHW-6
Responsible party: YUWELL MEDTECH USA LLC
Address: 2152 Serene Ct, Keller, TX 76248
Contact information
Name: Fang Zhang
Telephone number: (206) 639-1311
E-mail address: [email protected]
FCC Compliance Statement
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.

Specifications

Yuwell YHW-6 Questions and Answers

See other models: YHT107 YHW-5 YT-2 YHT202 YHT208