Comper IR-FT User manual

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User Manual
of Infrared Forehead Thermometer
Model: IR-FT
Comper Chuangxiang（Beijing）Technology Co., Ltd

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Table of Contents
1.Information on registrant/manufacturer................................................................................................................... 3
2.Product introduction ................................................................................................................................................. 4
3.Intended use:............................................................................................................................................................. 4
4.Structural composition:............................................................................................................................................. 4
5.Name of components:............................................................................................................................................... 4
6.Correct application methods..................................................................................................................................... 6
1). Preventive inspections:................................................................................................................................ 6
2). Unpacking:................................................................................................................................................... 7
3). Battery installation or replacement.............................................................................................................. 7
4). Operation procedures................................................................................................................................... 8
7.Contraindications, precautions, warnings and prompts ......................................................................................... 10
1). Contraindications....................................................................................................................................... 10
2). Precautions................................................................................................................................................. 10
3).Warnings.................................................................................................................................................... 10
8.Maintenance, cleaning, repair and maintenance period..........................................................................................11
9.List of accessories................................................................................................................................................... 12
10.Interpretation on the contents such as figures, symbols and abbreviations used by the medical device labels.. 12
11.Troubleshooting.................................................................................................................................................... 13
12.Clinical accuracy: ................................................................................................................................................. 14
13.Statement............................................................................................................................................................... 14
14.Description on the replacement cycle and method of consumables and batteries............................................... 14
15.Thermometer modes............................................................................................................................................. 15
16.Relevant EMC information................................................................................................................................... 15
Warranty Information............................................................................................................................................. 19

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1. Information on registrant/manufacturer
Name of registrant: Comper Chuangxiang（Beijing）Technology Co., Ltd
Address of registrant: 102,103 - F1, Room 203,213 - F2, Building 4, No. 1 Kangding Street, Beijing
Economic-Technological Development Area, Beijing
Contact information of registrant: [phone]
Name of manufacturer: Comper Chuangxiang（Beijing）Technology Co., Ltd
Address of manufacturer: 102,103 - F1, Room 203,213 - F2, Building 4, No. 1 Kangding Street,
Beijing Economic-Technological Development Area, Beijing
Address of manufacturing site: Room 102,103, F1, Building 4, No. 1 Kangding Street, Beijing
Economic-Technological Development Area, Beijing
Contact information of manufacturer: [phone]
Production date: See the labels;
Batch No./Serial No. of product: See the labels;
Service life: 3 years.
After-sales service unit: Comper Chuangxiang（Beijing）Technology Co., Ltd
Address of after-sales service unit: Room 102,103, F1, Building 4, No. 1 Kangding Street, Beijing
Economic-Technological Development Area, Beijing
Contact number: [phone] Fax: [phone]
Version: A/0
Date of issuance: November 28, 2018

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2. Product introduction
This Forehead Thermometer takes the body temperature by measuring the infrared energy emitted
from the forehead skin above the eyebrows. The Forehead Thermometer adopts gentle-touch, user
friendly and non-invasive measurement design. It instantly displays the accurate reading of the body
temperature with just a gentle forehead touch.
3. Indication for use:
This device is a non-sterile, reusable, contact Infrared thermometer intended for intermittent
determination of human body temperature in a touch on the center of the forehead as the
measurement site on people of all ages.
This device can be used in clinical hospital and home.
4. Structural composition:
The product is mainly composed of a temperature sensor, a housing, a circuit board and a battery
compartment.
5. Name of components:
As shown in Figure 1, the product is composed of five components:
Figure 1
①LED Display ②Power/Temperature Measurement Button ③Temperature Sensor ④
Temperature Measuring Probe
Declaration of replaceable parts
1. Use AAA manganese or alkaline dry batteries (two AAA batteries) only, otherwise device
failure may occur.

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2. Mount the positive and negative poles of batteries correctly. Replace the dying batteries in time
to avoid overheat, fluid leakage and damage of the batteries, which may further damage the
device.
3. Do not attempt to repair the product by yourself. In case of any quality issue or any doubt
about the measurement accuracy of thermometer, please contact the dealer or the manufacturer.
4. Please dispose of the replaced components (e.g. dry batteries) and the device reaching the end
of service life according to the local laws and regulations.
Technical indicators
Product name
Infrared Forehead Thermometer
Model/specification
IR-FT
The type of
temperature
measurements
Infrared, Forehead
Temperature display
range
32.0℃~43.0℃ (89.6℉-109.4℉)
Maximum allowable
error
≤±0.2℃ (0.4℉), for the range 35℃-42℃ (95℉-107.6℉);
≤±0.3℃ (0.5℉)，for the range 32℃-34.9℃ (89.6℉-94.8℉) and
42.1-43℃ (107.8℉-109.4℉).
Clinical repeatability
≤±0.3℃ (0.5℉)
Temperature unit
℃/ ℉
Display resolution
0.1℃ (0.1℉)
Operating environment
Temperature: 10℃~40℃(50℉-104℉); Relative humidity: ≤95%;
Atmospheric pressure: 70 kPa~106 kPa; Power supply conditions:
internal DC power supply, D.C. rated value (1+5%) V and D.C rated
value (1-10%) V
Transportation and
storage conditions
Temperature: -20℃~+55℃(-4℉-131℉); Relative humidity: ≤95%;
Atmospheric pressure: 70 kPa~106 kPa
Power supply
D.C. 3 V (2 AAA dry batteries)
Time required for the
device to
obtain a steady state
reading
2 Seconds
Dimensions (mm)
125mm×35mm×26mm
Service life
3 years
Prompt functions
A prompt message will appear when the temperature is lower than 32℃
(89.6℉);
A prompt message will appear when the temperature is higher than 43℃
(109.4℉);

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Four short beeps are emitted to signal low battery when the actual supply
voltage of the product is ≤ 2.51 V.
Three short beeps are emitted to signal low environment temperature:
When the temperature is lower than 10±1℃ (50±1 ℉);
Three short beeps are emitted to signal high environment temperature:
When the temperature is higher than 40±1℃ (104±1 ℉).
A prompt message will appear after batteries are installed and device
starts up;
A “beep”is emitted to indicate that the measurement is completed.
Automatic shutdown
function
The product will automatically shut down after 60 s of inactivity.
Safety requirements
1. Classification according to the type of protection against electric
shock: Internally powered equipment;
2. Classification according to the degree of protection against electric
shock: Type BF applied part;
3. Classification according to the degree of protection against liquid
ingress: IP22;
4. Classification according to the safety degree of the product used in
the flammable anesthetic gas mixed with air, oxygen or nitrous
oxide: This equipment shall not be used in the flammable anesthetic
gas mixed with air, oxygen or nitrous oxide;
5. Classification according to the mode of operation: Continuous
operating equipment;
6. Power supply: D.C. 3 V (2 AAA dry batteries);
7. Whether the equipment has the defibrillation-proof applied part: No;
8. Whether the equipment has the signal input or output part: No;
9. Permanently installed equipment or non-permanently installed
equipment: None-permanently installed equipment;
10. Input power: Not applicable;
11. Electromagnetic compatibility is classified into Group 1, Class B
according to CISPR 11.
The patient is an intended operator and can perform the maintenance the equipment.
6. Correct application methods
1) Preventive inspections:
- Measure and check the functions of each component to maintain good condition of
Forehead Thermometer.

- Check to make sure the batteries have enough power.
- The packaged product can be transported via common vehicles. However, it is necessary to
prevent the product from rain, damp, extrusion and mechanical collision.
2) Unpacking:
Open the individual-packed color box, take out the package with Forehead Thermometer and
remove the Forehead Thermometer from the plastic tray.
3) Battery installation or replacement
- Open the battery cover and replace the batteries. Mount the positive and negative poles of
the batteries correctly.
- Please use disposable batteries instead of rechargeable batteries, especially using the
alkaline dry batteries.
-In long period storage, it is recommended to remove the batteries to prevent battery leakage
thus damaging the product since the device’s quiescent current is very low when it is not
working.
- Do not use expired batteries for the device.
The device adopts D.C. 3 V manganese or alkaline dry batteries (2 AAA batteries). When the LED
shows “ ”, it indicates that it is in low battery state and the batteries must be replaced as soon
as possible to ensure measurement accuracy. Please dispose of the replaced components (e.g. dry
batteries) and the hosts reaching the end of service life according to the local laws and regulations.
Precautions
1. When opening the battery cover to replace the batteries, pay attention to the positive and
negative poles. Dying batteries should be removed immediately. Incorrect mounting will
cause damage to the product.
2. In long period storage, please remove the batteries to prevent damage to the thermometer
by fluid leakage.
3. Do not use the product in case of battery leakage or mold.
4. Do not take the battery close to the fire or put it into fire to avoid battery explosion.
5. Do not store the battery in a high-temperature or high-humidity environment.
6. To avoid short circuit, do not place the battery together with metal objects such as coins
or keys in the same pocket or other containers that may cause battery short circuit.
7. In case of exposure of eyes to the electrolyte in the battery by mistake, rinse immediately
with plenty of water. In case of any hazard causing injuries such as blindness, go to the
nearest hospital for medical treatment immediately.
8. In case of exposure of skin or clothes to the electrolyte in the battery by mistake, rinse
immediately with plenty of water, otherwise it may damage the skin.
Prompt: The emissivities of various materials may be different. Please refer to the material
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emissivity. The default emissivity of this product is 1.0. The measured temperature will deviate
from the actual value for different emissivities.
4) Operation procedures
4.1 Measurement
-Power On/Off: In the Off state, lightly press the “Power/Temperature Measurement Button”
for to start up. The device will start self-inspection and the LED screen will be fully on. It
will be ready for measurement after the self-inspection.
- Measurement and body temperature judgment
Ensure that the temperature measuring probe of Forehead Thermometer is in full contact with the
center of forehead. Lightly press the “Power/Temperature Measurement Button”. The measurement
is completed after hearing a long “Click” sound. The LED will display the temperature
measurement result. The next measurement can be performed after hearing a short “Click” sound.
-Sleep/Wakeup
If there is no further operation, the Forehead Thermometer will enter the sleep state 10 s after
displaying the measurement result. It is feasible to wake up the device by lightly pressing the
“Power/Temperature Measurement Button”.
- Shutdown

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After 1 min of inactivity, the Forehead Thermometer will automatically shut down.
Precautions
1. Be sure to read the IFU carefully prior to use.
2. The ambient temperature applicable to this product is 10℃ (50℉)to 40℃ (104℉), where
25℃ (77℉) is optimal.
3. Please do not take this product too close to a charged object to avoid electric shock.
4. Please do not use this product in an environment with a relative humidity greater than 95%.
5. Please do not take this product too close to an electromagnetic environment (such as radio and
mobile phone).
6. Please do not expose this product to the sun or close to a stove, or even water.
7. Please do not hit or drop this product. Do not use the product if it is damaged.
8. The hair and sweat on the forehead, hat or scarf may affect the accuracy of measured data.
9. Please validate that the measurement distance shall not be greater than 1 cm.
10. In order to obtain accurate, stable and reliable measured data, when the room temperature
varies greatly, the product should be placed in the same environment with the measured object
for 30 min prior to use.
11. In case of forehead sweating or other circumstances that the forehead temperature cannot
reflect the body temperature normally for other reasons, please measure behind the earlobe.
12. When cleaning is required, gently wipe the surface of probe with alcohol.
13. In case of any problem with the product, please contact the company at 010-57480968. Do not
try to repair it by yourself.
14. Please do not use the product with wet hands.
15. The product is not waterproof and should not be exposed to water.
4.2 Sleep/Wakeup
If there is no further operation, the Forehead Thermometer will enter the sleep state 10 s after
displaying the measurement result. It is feasible to wake up the device by lightly pressing the
“Power/Temperature Measurement Button”.
4.3 Shutdown
After 1 min of inactivity, the Forehead Thermometer will automatically shut down.
4.4 Display icon definition
Function definition
Icon
Status description
Battery prompt
Display and flash
The battery is extremely low and the
product is not working properly.
Replace the batteries immediately.
No display
Full battery
Temperature unit
℃/℉
Degrees Celsius/ Degrees Fahrenheit
Displayed value
Measured temperature value
Low temperature
warning
In body temperature mode, if the measured temperature is
lower than 32.0℃ (89.6℉)

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High temperature
warning
In body temperature mode, if the measured temperature is
higher than 43.0℃ (109.4℉)
Error prompt
Err
When the ambient temperature range is beyond 10℃~40℃
(50℉-104℉)
ErrH
Hardware fault
ErrE
Storage hardware fault
7. Contraindications, precautions, warnings and prompts
1) Contraindications
Currently none
2) Precautions
- The product is an infrared forehead thermometer for professional measurement of body
temperature. The measured temperature will vary depending on the skin of human body.
- When the measured object and the forehead thermometer are not in the same environment,
place the infrared forehead thermometer in the same environment with the measured object
for 30 min prior to use.
- The environment around the measured object should be stable. Do not make measurement
at places with large airflow such as air outlet of fan and air conditioner, etc.
- Do not use the device outdoors or under strong sunlight.
- Do not hold the front end of thermometer while measuring.
- The measurement site cannot be covered by hair. In case of any sweat stain, wipe clean with
a dry towel before measuring. Otherwise, it will affect the measurement result.
- The measurement result will be lower after taking cooling measures such as cold compress
and sweating on the forehead of patients with fever. Therefore, do not make measurement
in such cases.
- There is no standard value specified for body temperature. Please consult a doctor to see if
you are in fever.
- The device is MR unsafe.
3) Warnings
It is very dangerous to make self-judgment on the measurement result or carry out treatment. Please
follow the doctor's instructions.
●Self-judgment may lead to illness exacerbation.
Medical care is needed in case of excessive body temperature or high body temperature for a long
time, especially for infants. Please consult the doctor promptly.

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●It may lead to illness exacerbation.
If the device is to be left idle for a long time (over 3 months), remove the batteries and keep out of
the reach of children.
●Otherwise, it may cause ingestion by children.
Keep the product out of the reach of children. At the same time, please prevent the children from
using the device alone.
●Otherwise, it may cause injury to children or damage to the equipment.
Please dispose of the used-up batteries according to the local requirements.
●Otherwise, it may cause fire due to battery explosion, thus resulting in burns and injury.
Do not collide, drop, step on or vibrate the product intensively. Otherwise, it may cause product
damage, thus resulting in injury.
8. Maintenance, cleaning, repair and maintenance period
Before use of product, we recommend thorough cleaning of the device according to the
method below, and if the device is determined not to be visually clean at the end of the
cleaning step, the user should either repeat the relevant previous cleaning steps or safely
dispose of the device, so that a visibly soiled device is not used again.
1) Please clean and maintain the product as follows:
●Step 1: Power off the thermometer by switch.
●Step 2: Examine the thermometer for visual contamination.
●Step 3: Wipe with a soft cloth dipped with 70% isopropyl alcohol, until the probe surface is
clean and free of dirt by visual test.
Do not touch the temperature sensor. In case it is dirty, do not clean with water or detergent.
Please use 70% isopropyl alcohol to wipe it clean instead.
The product is not waterproof. Do not clean with detergent or immerse the thermometer into
water or other liquids.
●Step 4: Allow the thermometer to air dry completely for at least 1 min.
●Step 5: After cleaning and drying, visually examine the thermometer for any remaining
contamination; if contamination is present, please repeat Step 3-4 until the contaminants are no
longer present.
2) Do not store the product in the following places, as it may cause damage:
●Places prone to water splashing;

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●Places with high temperature, moist, direct sunlight exposure, dust and being salty.
●If the product is to be left idle for a long time (over 3 months), please remove the batteries for
safekeeping.
3) About safekeeping
●When not in use, store it in a locker/box.
4) Maintenance period
●The product shall be cleaned and maintained after each use.
Product repair
Do not repair the product by yourself. In case of any quality issue or any doubt about the
measurement accuracy of thermometer, please contact the dealer or the manufacturer.
Recommended cleaning and disinfection procedures
After each use of the product, wipe clean the dirt place with a clean soft cloth or wipe clean the
surface of product and the probe with a soft cloth soaked with 75% (volume ratio) ethanol solution.
9. List of accessories
In case of any inconsistency between the physical object and the following information, please
contact the manufacturer.
No.
Accessory
Quantity
1
Forehead Thermometer Host
1
2
Battery (AAA manganese or
alkaline dry battery)
2
3
Instructions for Use
1
4
Qualification Certificate
1
10. Interpretation on the contents such as figures, symbols and abbreviations used by the
medical device labels
Marks and graphic symbols
Marks on the product and package
Consult the Instructions for
Use
Caution, consult accompanying
documents

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Type BF applied part
Keep dry
Low battery prompt
Avoid sunlight
Straight up
Fragile; Handle with care
Discarded electronic or
electrical equipment
Radio transmitting equipment
Serial number
Date of manufacture
Manufacturer
11. Troubleshooting
Failure/issue
Possible cause
Measures that can be taken
Higher
measurement result
Make measurement immediately after
taking the forehead thermometer into a
room under normal temperature when it is
stored in a cold environment.
Make measurement 30 min later after
placing the forehead thermometer in the
room where using the product.
The probe is always exposed to direct
sunlight.
Make measurement 30 min later after
placing the forehead thermometer in the
room where using the product.
Make measurement immediately when the
measured object is in excited emotion.
Excited emotion can rise the facial
temperature. Please make measurement
after the measured object gets calm.
Lower measurement
result
Body sweating
Do not use the product after swimming,
bathing or sweating after exercise because
the skin temperature will drop in such
circumstances. Wipe off water and wait for
30 min before measuring.
The probe is dirty.
Please clean the probe with soft cotton
cloth dipped with 75% alcohol.
Make measurement on the measured object
immediately after he/she enters indoor
space from outdoors in cold weather.
Please wait until the forehead has warmed
up before measuring.
Measure the body temperature at other
sites except the forehead.
Please use the product only for temperature
measurement at forehead.
Difference in
measurement results
Measurements were not made at the same
site.
Make measurements at the same site.
The measurement site was covered by
foreign matters such as hair during
Ensure that the measurement site is not
covered before measurement.

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measurement.
12. Clinical accuracy:
The normal body temperatures are within a certain range. The body temperatures measured at
different sites will be different. See the specific differences in the following table:
Measurement site
Normal body temperature
Deviation
Forehead
temperature
34.7℃~37.8℃
(94.5℉-100℉)
0.3℃~0.5℃ (0.5-0.9℉)
lower than the oral
temperature
The product is applicable to people of all ages. The body temperatures of different groups will be
different. See the specific differences in the following table:
Age group
Normal body temperature
Clinical deviation
At the age of 0-2
36.4℃~38.0℃
(97.5℉-99.5℉)
≤±0.3℃(0.5℉)
At the age of 3-10
36.1℃~37.8℃
(97℉-100℉)
≤±0.2℃(0.4℉)
At the age of 11-65
35.9℃~37.5℃
(96.6℉-99.5℉)
≤±0.2℃(0.4℉)
At the age of 65 above
35.8℃~37.4℃
(96.4℉-99.2℉)
≤±0.3℃(0.5℉)
Caution: Depending on the person's skin color, thickness and body part and great changes of
ambient temperature, the measured body temperature valueswill be different, which is quite normal.
The reason is that the body parts more frequently exposed to the external environment will be more
affected by the ambient temperature.
13. Statement
The product is intended to measure heat radiation from the forehead to display body temperature. It
has been verified for clinical accuracy. The performance verification method for the product can be
accessed by contacting our Customer Service Department.
14. Description on the replacement cycle and method of consumables and batteries
The detachable components of this product mainly include the batteries. Before installing the
accessories, please confirm whether the specifications of accessories are consistent with the original
specification. Please use the components of models specified by the company. Contact the dealer or
manufacturer if necessary.
Battery mounting and replacement:

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When a low battery prompt symbol appears on the display screen, please replace with dedicated
batteries. Battery mounting and replacement should follow Part 3 "Battery mounting and
replacement methods" in "Correct application methods" of the Instructions for Use.
15. Thermometer modes
Comper Smart Infrared Forehead Thermometer has the measurement mode and calibration mode.
The measurement mode is the normal use mode for the user, while the calibration mode is only
available for the manufacturer for production and is not open to the user.
16. Relevant EMC information
Cautions:
●IR-FT Infrared Forehead Thermometer meets the relevant requirements for electromagnetic
compatibility in IEC60601-1-2;
●Users should assemble and operate the equipment according to the EMC information provided
in the accompanying documents;
●Portable and mobile RF communication equipment may affect the performance of IR-FT
Infrared Forehead Thermometer. Therefore during use, the product should be kept away from
electromagnetic interference resources, such as mobile phones and microwave ovens, etc.;
●See details of guidance and manufacturer's statement in the subsequent “Guidance and
Manufacturer's Statement”.
Warnings:
●IR-FT Infrared Forehead Thermometer shall not be used adjacent to or stacked with other
equipment and if adjacent or stacked use is necessary, it shall be observed to verify normal
operation in the configuration in which it will be used;
●If the physiological parameters measured by the equipment are lower than the specified
minimum values, the measurement results may be inaccurate.
Table 1: Electromagnetic emission
Guidance and manufacturer's statement - Electromagnetic emission
IR-FT Infrared Forehead Thermometer is intended for use in the electromagnetic environment as
specified below. The buyer or user of IR-FT Infrared Forehead Thermometer should assure that it is
used in such an environment:
Emission test
Compliance
Electromagnetic environment - –Guidance
RF emission
Group 1
IR-FT Infrared Forehead Thermometer uses RF energy

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CISPR 11
only for its internal function. Therefore, RF emissions
are very low and are not likely to cause any interference
to nearby electronic equipment.
RF emission
CISPR 11
Class B
IR-FT Infrared Forehead Thermometer is suitable for
use in all establishments, including domestic
establishments and those directly connected to the public
low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emission
IEC61000-3-2
Not applicable
Voltage
fluctuation/flicker
emission
IEC61000-3-3
Not applicable
Table 2: Electromagnetic immunity 1
Guidance and manufacturer's statement - Electromagnetic immunity
IR-FT Infrared Forehead Thermometer is intended for use in the electromagnetic environment as
specified below. The buyer or user should assure that it is used in such an environment:
Immunity test
IEC 60601 Test Level
Compliance
level
Electromagnetic
environment - –
Guidance
Electrostatic
discharge
IEC61000-4-2
±6 kV, contact discharge
±8 kV, air discharge
±6 kV, contact
discharge
±8 kV, air
discharge
Floors shall be wood,
concrete or ceramic tile.
If floors are covered with
the synthetic material, the
relative humidity should
be at least 30%.
Electrical fast
transient burst
IEC61000-4-4
±2 kV, for power supply
lines
±1 kV, for input/output lines
Not applicable
Not applicable
Surge
IEC61000-4-5
±1 kV, differential-mode
voltage
±2 kV, common-mode
voltage
Not applicable
Not applicable
Voltage dip, short
interruption and
voltage variation on
power supply input
lines
IEC61000-4-11
<5% UT, for 0.5 cycle
(>95% dip in UT)
40% UT, for 5 cycles
(60% dip in UT)
70% UT, for 25 cycles
(30% dip in UT)
＜5% UT, for 5 s
(>95% dip in UT)
Not applicable
Not applicable
Power-frequency
magnetic field (50/60
Hz)
3A/m
3A/m, 50/60 Hz
The power-frequency
magnetic field shall be at
the level characteristic of

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IEC61000-4-8
a typical location in a
typical commercial or
hospital environment.
Note: UTis the a.c. mains voltage prior to application of the test voltage.
Table 3: Electromagnetic immunity 2
Guidance and manufacturer's statement - Electromagnetic immunity
IR-FT Infrared Forehead Thermometer is intended for use in the electromagnetic environment as
specified below. The buyer or user of IR-FT Infrared Forehead Thermometer should assure that it is
used in such an environment:
Immunity test
IEC 60601 Test level
Compliance
level
Electromagnetic environment - –
Guidance
RF conduction
IEC61000-4-6
RF radiation
IEC61000-4-3
3 V (r.m.s.)
150 kHz~80 MHz
3 V/m
80 MHz~2.5 GHz
Not applicable
3 V/m
Portable and mobile RF communication
equipment shall be used not closer to
any part of IR-FT Infrared Forehead
Thermometer, including cables, than the
recommended separation distance. The
distance shall be calculated according to
the formula applicable to the frequency
of the transmitter.
Recommended separation distance
d =
P2.1
d =
P2.1
80 MHz~800 MHz
d =
P3.2
800 MHz~2.5 GHz
where:
P
—The maximum rated output power
of the transmitter in watts (W) according
to the transmitter's manufacturer;
d—The recommended separation
distance in m b.
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site surveyc, should be
less than the compliance level in each
frequency ranged.
Interference may occur in the vicinity of
equipment marked with the following
symbols.
Note 1: At 80 MHz and 800 MHz, the formula used for higher frequency range applies.
Note 2: These guidances may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and human bodies.

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a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment of fixed RF
transmitters, an electromagnetic site survey shall be considered. If the measured field strength in the
location in which the IR-FT Infrared Forehead Thermometer is used exceeds the applicable RF
compliance level above, the IR-FT Infrared Forehead Thermometer should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating the IR-FT Infrared Forehead Thermometer.
b. Within the frequency range from 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 4: Recommended safe distance
Recommended separation distance between portable and mobile RF communication equipment
and the IR-FT Infrared Forehead Thermometer
IR-FT Infrared Forehead Thermometer is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The buyer or user can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communication
equipment (transmitters) and the equipment or system, according to the maximum rated output power
of the communication equipment.
Maximum rated output
power of
transmitter/W
Separation distance according to the frequency of transmitter/m
150 kHz ~ 80 MHz
d =
P2.1
80 MHz ~ 800 MHz
d =
P2.1
800 MHz~ 2.5 GHz
d =
P3.2
0.01
Not applicable
0.12
0.23
0.1
Not applicable
0.38
0.73
1
Not applicable
1.2
2.3
10
Not applicable
3.8
7.3
100
Not applicable
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance din meters (m) can be determined using the formula applicable to the frequency of the
transmitter, where Pis the maximum rated output power of the transmitter in watts (W) provided by
the transmitter's manufacturer.
Note 1: At 80 MHz and 800 MHz, the formula used for higher frequency range applies.
Note 2: These guidances may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and human bodies.

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Warranty Information
From the date of purchasing the equipment, you can enjoy the following after-sales services
provided by comper with the purchase invoice: One-year Warranty.
Warranty principle:
1. Free warranty for products with host quality issues within one year;
2. Please deliver the product to the address of after-sales service unit of
comper for repair.
3. The issues arising from battery leakage, repair and disassembly on
one's own, man-made damage, natural disasters and force majeure,
etc. are beyond the warranty coverage.
Declaration of Conformity
The IR-FT Infrared Forehead Thermometer meets requirements established in ASTM E 1965 for the
thermometer system. And Comper Chuangxiang （Beijing）technology Co., Ltd (Add: Room
102,103 1st Floor, Unit 4,No.1 Kangding Street, Beijing Economic Technology Development Area，
Beijing, China) take full responsibility for the conformance of the thermometer to the standard.
The IR-FT Infrared Forehead Thermometer conforms to the following standards:
IEC 60601-1:2005+A1:2012 Medical electrical equipment –Part 1: General requirements for basic
safety and essential performance.
ISO-80601-2-56 Medical electrical equipment —Part 2-56: Particular requirements for basic safety
and essential performance of clinical thermometers for body temperature measurement.
ASTM E 1965-98:2016 Standard specification for infrared thermometers for intermittent
determination of patient temperature.
ISO 10993-1:2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within
a risk management process.
IEC60601-1-2:2014 Medical electrical equipment –Part 1-2: General requirements for basic safety
and essential performance –Collateral standard: Electromagnetic compatibility –Requirements and
tests.
ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels, labelling and
information to be supplied -- Part 1: General requirements.
IEC 60601-1-11:2015 Medical electrical equipment -- Part 1-11: General requirements for basic
safety and essential performance -- Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment.

20/21
Federal Communications Commission (FCC) Statement
1) This device may not cause harmful interference and
2) This device must accept any interference received, including interference that may cause
undesired operation.
15.21
Changes or modifications not expressly approved by the party responsible for compliance could
void the user's authority to operate the equipment.
15.105(b)
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection
against harmful interference in a residential 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.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
- Consult the dealer or an experienced radio/TV technician for help.
FCC RF Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled
environment. End users must follow the specific operating instructions for satisfying RF exposure
compliance. This transmitter must not be co-located or operating in conjunction with any other
antenna or transmitter.