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.