Comper IR-EFT User manual

Instructions for Use (IFU) of ThermArt
Model: IR-EFT
Comper Chuangxiang（Beijing）Technology Co., Ltd

Table of Contents
Information of Manufacturer................................................................................................................................. 1
Product introduction .............................................................................................................................................. 2
Intended use........................................................................................................................................................... 2
Product composition.............................................................................................................................................. 2
Specifications ........................................................................................................................................................ 3
How to use............................................................................................................................................................. 4
Features .................................................................................................................................................................5
1. Unit Conversion..................................................................................................................................... 5
2. Power off ...............................................................................................................................................5
3. Bluetooth connection............................................................................................................................. 5
4. Dual measurement modes...................................................................................................................... 5
5. Low battery indication...........................................................................................................................5
Precautions ............................................................................................................................................................ 6
Warnings................................................................................................................................................................ 7
Precautions for battery installation or replacement ............................................................................................... 8
Care and Cleaning .................................................................................................................................................8
Product repair ........................................................................................................................................................ 9
Recommended cleaning and disinfection procedures............................................................................................ 9
Symbols................................................................................................................................................................. 9
Troubleshootings .................................................................................................................................................10
Statement............................................................................................................................................................. 11
Description on the replacement cycle and method of consumables-- batteries ................................................... 11
Calibration Mode................................................................................................................................................. 11
Relevant EMC information ................................................................................................................................. 11
Declaration of Conformity .................................................................................................................................. 15
Warranty Information .......................................................................................................................................... 16

1
Information of Manufacturer
Manufacturer: Comper Chuangxiang（Beijing）Technology Co., Ltd
Address : Room 102,103 - F1, Room 203,213 - F2, Building 4, No. 1 Kangding Street,
Beijing Economic-Technological Development Area,
Beijing 100176, China
Contact Phone: [phone]
Production date: See the device labels.
Product Lot No./Serial No.: See the box labels.
Shelf life: 3 years.
Version: A/0
Revised Date: July 23, 2019
Please read the instructions carefully before using the product.
Keep the manual in a safe place for future reference.

2
Product introduction
ThermArt is an infrared forehead and ear thermometer which is hand-held, non-sterile, reusable
and battery-powered. It is designed to measure human body temperature via one of two body sites:
the ear canal or skin of the forehead.
The device uses infrared technology to measure the natural thermal infrared energy emitted from
the surface of the skin of the forehead or from the eardrum tissue.
Intended use
ThermArt is intended for the spot measurement of human body temperature on people of all ages.
The device is for both non-professional use by consumers and professional use by doctors.
Product composition
Structural composition: This product is mainly composed of infrared temperature sensor,
temperature probe, LED display, and PCBA.
Parts List: As shown in Figure 1, it is composed of seven parts
Figure 1
①LED Display ②Battery Compartment ③Power/Measurement Button ④Ear probe
cover ⑤Forehead Probe ⑥Infrared Temperature Sensor ⑦Ear Probe

3
Specifications
Product name
ThermArt
Model
IR-EFT
Temperature display
range
Measurement Mode:
Forehead temperature mode: 89.6°F – 109.4 °F/32.0°C-43°C
Ear temperature mode: 89.6°F – 109.4 °F / 32°C-43°C
Calibration Mode:
Forehead temperature mode: 71.6°F – 109.4 °F/22.0°C-43°C
Ear temperature mode: 89.6°F – 109.4 °F / 32°C-43°C
Precision
±0.4°F/±0.2°C (89.6°F – 109.4 °F/32.0°C-43°C)
±0.5°F/±0.3°C (outside this temperature range)
Temperature unit
℃/ ℉, adjustable
Display resolution
0.1℃(0.1℉)
Operating environment
(59°F-104°F)15°C-40°C /15-95%RH
Bluetooth frequency
range
2.402GHz-2.480GHz
Bluetooth TX power
20dBm
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 alkaline batteries)
Dimensions
W83 mm×H77 mm×D28 mm/108g (W3.27” x H3.03”xD1.10” / 0.238lbs)
Protection against
electric shock
Internal power supply/ Type BF applied part
Disinfection and steriliz
ation
Refer to chapter Care and Cleaning, the method recommended by the
manufacturer
Safety classification
The equipment cannot be used in the presence of flammable anesthetic gases
mixed with air or flammable anesthetic gases mixed with oxygen or oxidized
nitrogen.
Operation
mode classification
Continuous operating equipment
Electromagnetic
compatibility
According to CISPR 11: Group I Class B
Protection level of liquid
intake
Common equipment
Box Contents
ThermArt Thermometer, 20pcs of ear probe cover (1 box), 2AAA batteries,
user manual, quick guide

4
How to use
Please follow the steps below to achieve the best measurement results.
1. Remove the forehead probe, open the battery compartment, make sure the poles are in right
direction and install the batteries.
2. Press“Power/Measure”button to turn the thermometer on.
3. The display shows all segments to complete an internal self-check, then you can start measuring
process after hearing a beep.
4. Measuring forehead temperature:
With the forehead probe attached, point and contact the thermometer at the center of the forehead.
Press and release the ON/ OFF button, read the temperature on the display after a long beep.
Measuring ear temperature:
Gently remove the forehead probe, put a new ear probe cover on the ear probe, fit the probe snugly
into the ear canal, then press the ON/OFF button, read the temperature on the display after a long
beep.
Notes:
1. Remove the forehead probe firstly before open the battery cover and install the battery.
2. Wait 3 seconds and start another measurement after hearing a beep.
3. In the ear mode, if the ear probe is not put on ear probe cover properly, will flash and it is
unable to take measurements. Make sure the ear probe cover is in place before each ear temperature
measurement.
4. Note on body temperature
⚫The normal body temperature is a range.
⚫The normal range varies from person to person and can fluctuate throughout the day.
⚫The normal range also varies by dody site. Therefore, measurements from different sites should
not be compared directly.
To determine if an individual is experiencing an elevated body temperature and/ or having a fever,

5
it is critical to know the individual’s normal body temperature when he/she is well. Take multiple
readings to obtain the normal body temperature range and note the specific body site measured, for
example: forehead or eardrum temperature.
Body Site
Normal Temperature Range
Forehead
94.5℉-99.1℉ （34.7℃-37.3℃）
Eardrum
96.4℉-100.4℉ （35.8℃-38.0℃）
Mouth
95.9℉-99.5℉ （35.5℃-37.5℃）
Armpit
94.5℉-99.1℉ （34.7℃-37.3℃）
Rectal
97.9℉-100.4℉ （36.6℃-38.0℃）
The normal body temperature range varies slightly with age and gender. Generally, newborns of
children have higher body temperatures than adults, and adults have higher body temperature than
the eldly. Women’s body temperatures are approximately 0.3℃（0.5℉）higher than men’s.
Features
1. Unit Conversion
Make sure the thermometer is turn off, press and hold the ON/OFF button for 3 seconds, release
the ON/OFF button when the display is light up. There will be a short beep to confirm the new
setting.
2. Power off
The ThermArt thermometer turns off automatically after 30 seconds of inactivity. OR press and
hold the ON/OFF button for 3 seconds to turn off the thermometer.
3. Bluetooth connection
The built-in Bluetooth automatically retrieves and connects for data transmission, the Bluetooth
icon " " will flash during the connection, and it will be always on after the connection is
successfully.
4. Dual measurement modes
When the forehead probe put on, the thermometer will run in forehead mode and the forehead
temperature icon " " will be light up.
When the forehead probe removed, the thermometer will switch to ear mode and the ear
temperature icon " " will be light up.
5. Low battery indication

6
The ThermArt thermometer is supplied with two AAA alkaline batteries. For best performance,
please insert new battery when the battery symbol “ ” appears on the display.
Precautions
1) Please install the forehead probe and ear probe cover correctly to ensure accurate measurement.
2) The forehead mode is contact measurement. Please contact the forehead probe to the center of
your forehead during measurement.
3) Please use clean and undamaged new ear probe cover for each ear temperature measurement.
4) When the probe needs to be cleaned, gently wipe the probe surface with 70% medical alcohol.
5) Please use the ear probe cover assigned by our company, or the measurement may be inaccurate.
Please contact [e-mail] for assistance if you don’t kown where to purchase the ear
probe cover.
6) DO NOT move during measurement.
7) DO NOT force the probe into the ear to avoid ear canal injury.
8) The thermometer is intended for indoor use. Wind turbulence will adversely affect the accuracy
of the device. DO NOT take measurements in places with large airflow, such as facing to the fans
and air conditioner vent.
9) DO NOT use the device outdoors or under strong sunlight.
10) DO NOT hold the thermometer probes with your hand during measurement, so as to avoid the
influence of heat on the accuracy of the measurement results.
11) The measured part shall not be covered by hair. If you have sweat stains, wipe them with a dry
towel before taking a measurement.
12) If the patient feels pain or discomfort in the ear canal during ear temperature measurement,
please stop using this product immediately.
13) Make sure that both user and thermometer have stayed in steady-state room condition for at
least 30 minutes. Recent exposure to hot or cold temperatures will impact the reading.
14) If taking multiple measurements, it is advised to wait at least 5 seconds between measurements.
The thermometer is very sensitive to small changes in temperature, repeated use with no pause may
impact your reading.
15) DO NOT use the thermometer immediately after using ice pack or entering room from outside
in winter. In such cases, please wait until the forehead or ears are warm before taking a
measurement.
16) When the probe becomes dirty, gently wipe it with a soft dry cloth or cotton swab. Do not wipe
the probe with paper or towels.

7
17) DO NOT submerge the thermometer in any type of liquid, it is not waterproof. When wet due
to contact with steam, wait until dry or gently wipe with a soft dry cloth.
18) DO NOT use the thermometer under an ambient temperature higher than 40°C (104°F) or lower
than 15°C (59°F), which is beyond the operating temperature range of the thermometer. To ensure
accurate readings, keep the thermometer under room temperature for more than 30 minutes before
use.
19) DO NOT use this product in areas with strong static electricity or electromagnetic fields.
20) DO NOT use the product with wet hands.
21) DO NOT charge the battey or put the battery into fire. Please discard the used battery in the
designated recycling place.
22) When the thermometer ends of life or ready to be scrapped, please take out the batteries and
dispose of them separately, discard the used battery in the designated recycling place.If possible,
send the discarded thermometer to the recycle bin and dispose according to local laws and
regulations.
23) If there is any problem with the thermometer, please contact the agent or manufacturer, and do
not try to fix it by yourself.
Warnings
It is very dangerous to make self-judgment or do treatment based on the measurement result. Please
follow the doctor's instructions.
Self-judgment may lead to illness exacerbation.
Medical care is needed in case of high body temperature for a long time, especially for infants.
Please consult a doctor promptly.
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.
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.
It may cause injury to children or damage to the thermometer.
Please dispose of the used-up batteries according to the local laws and regulations.
It may cause fire due to battery explosion, thus resulting in burns and injury.
Do not collide, drop, step on or vibrate the product terribly.
It may cause product damage, thus resulting in injury.

8
Precautions for battery installation or replacement
Care and Cleaning
1) Please clean and maintain the product as follows:
Use a soft and dry cloth dipped with 70% alcohol to disinfect the temperature measuring probe.
To clean the temperature sensor, gently swab the surface with a cotton swab moistened with
70% alcohol. Do not touch the temperature sensor and clean with water or detergent.
Wait for the alcohol to evaporate completely before using the temperature. This may take about
5-10 minutes. Any residual alcohol will make inaccurate readings.
Pay attention to the probe and sensor during operation to avoid damage.
The product is not waterproof. Do not clean with detergent or immerse the thermometer into
water or other liquids.
2) Do not store the product in the following places, as it may cause damage:
Places prone to water splashing;
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
Precautions
1. When opening the battery cover to replace the batteries, pay attention
to the positive and negative poles. 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 batteries in case of battery leakage or mold.
4. Do not take the battery close to the fire or put it into the 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 the eyes 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.

9
safekeeping.
3) Safekeeping
When not in use, store the thermometer in a locker or box.
4) Maintenance period
It is recommended to clean and maintain the thermometer 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 the 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 the product and the probe with a soft cloth soaked with 70% (volume ratio) ethanol
solution.
Symbols
Symbol
Description
Symbol
Description
Consult the
Instructions for Use
Caution, consult accompanying
documents
Type BF applied
part
Keep dry
Low battery
indication
Avoid sunlight
Radio transmitting
equipment
Serial Number
Discarded electronic
or electrical
equipment
Transportation and storage
temperature
Transportation and
storage pressure
Transportation and storage
humidity
Manufacturer
Date of manufacture

10
Troubleshootings
Symptom
Possible cause
Solution
High
measurement
result
The thermometer is used within 30
minutes after taking from a cold
Remove the thermometer from the
situation and wait for 30 minutes in
a steady-state room condition before
taking a temperature.
The thermometer probe is exposed
to direct sunlight for a long time.
The thermometer is used on an
individual in excited emotion
Please take measurement after
getting calm.
Low measurement
result
Sweating body
Dry the body and wait for 30
minutes after swimming, bathing or
sweating.
The probe is dirty.
Clean the probe with a soft clean
cloth dipped with 70% alcohol.
The thermometer is used
immediately after getting in room
from outdoors in cold weather.
Please wait until the body warms up
before taking a measurement.
Difference in
measurement
results
Measurements were not taken on the
same body parts.
Take and compare the
measurements from the same body
parts, e.g the same right ear.
The forehead or ears are covered
with foreign body.
Remove the foreign body before
taking a measurement.
“ErH”is displayed
Hardware failure
Please contact your supplier.
“ErE”is displayed
Memory failure
Please contact your supplier.
3 short beeps and
“Lo”is displayed
The measured forehead temperature
is lower than 32℃(89.6℉).
The measured ear temperature is
lower than 22℃(71.6℉).
Check if the forehead probe is
installed properly and please attach
the probe to the center of forehead to
take measurements.
Take measurements after confirm
the ear probe cover and the probe are
clear.
3 short beeps and
“H1”is displayed
The measured temperature is higher
than 43℃(109.4℉)
Check if the probe and ear probe
cover are in good condition before
taking a measurement.
3 short beeps and
“Err”is displayed
The time interval between two
measurements are less than 3
seconds.
Wait for 3 seconds and take another
measurement after hearing a short
beep indication.
The ambient temperature exceeds
15.0℃-40.0℃（59.0℉-104.0℉）
Make sure that both user and
thermometer have stayed in a 15℃-

11
40℃（59.0℉-104.0℉）room for 30
minutes.
Statement
The ThermArt is to measure human body temperature by detecting natural thermal infrared
radiation from the forehead or ear. It has been clinically proven in accuracy and repeatability. Its
safety and effectiveness are both in compliance with the relevant international regulatory
requirements.
Description on the replacement cycle and method of consumables-- batteries
The detachable components of this product mainly are the batteries. Before installing the
accessories, please confirm if the specifications of accessories are consistent with the requirements
stated by supplier. Please use the models of components specified by supplier. Contact the dealer
or manufacturer if necessary.
When the low battery indication icon appears on the display , please replace with new batteries.
Calibration Mode
The ThermArt has both measurement mode and calibration mode. The measurement mode is for
the use of measuring the temperature of forehead or ear,
while the calibration mode is used for measuring the temperature of body skin or object surface.
The default factory mode is measurement mode.
The method to switch these two modes: install the batteries and long press the button at the same
time until the display is light up.
After the device is turn off, the product will restart in measurement mode.
Relevant EMC information
Cautions:
⚫IR-EFT ThermArt meets the relevant requirements for electromagnetic compatibility in
IEC60601-1-2;
⚫Users should install 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-EFT
Infrared Forehead and Ear Thermometer. Therefore during use, the product should be kept
away from electromagnetic interference resources, such as radio station and microwave ovens,
etc.;

12
⚫See details of guidance and manufacturer's statement in the subsequent “Guidance and
Manufacturer's Statement”.
Warnings:
⚫IR-EFT ThermArt shall not be used adjacent to or stacked with other equipment, and if adjacent
or stacked use is necessary, it shall be verified the device can work in normal 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-EFT ThermArt is intended for use in the electromagnetic environment as specified below.
The buyer or user of IR-EFT ThermArtshould assure that it is used in such an environment:
Emission test
Compliance
Electromagnetic environment - Guidance
RF emission
CISPR 11
Group 1
IR-EFT ThermArt uses RF energy 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-EFT ThermArtis 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-EFT ThermArtis 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

13
relative humidity
should be at least 30%.
Electrical fast
transient burst
IEC61000-4-4
±2 kV, to power supply
lines
±1 kV, to 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 cycles
(>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 5s
(>95% dip in UT)
Not applicable
Not applicable
Power frequency
magnetic field
(50/60 Hz)
IEC61000-4-8
3A/m
3A/m,50/60Hz
The power-frequency
magnetic field shall be
at the level
characteristic of a
typical location in a
typical commercial or
hospital environment.
Note: UT is the a.c. mains voltage prior to application of the test voltage.
Table 3: Electromagnetic immunity 2
Guidance and manufacturer's statement - Electromagnetic immunity
IR-EFT ThermArt is intended for use in the electromagnetic environment as specified below.
The buyer or user of IR-EFT ThermArt should assure that it is used in such an environment:
Immunity test
IEC 60601 Test Level
Compliance
level
Electromagnetic environment - Guidance
RF
3 V (r.m.s.)
Not
Portable and mobile RF communication
equipment shall be used not closer to any
part of IR-EFT Infrared Forehead and Ear
Thermometer, including cables, than the
recommended separation distance. The
distance shall be calculated according to
the formula applicable to the frequency
of the transmitter.

14
conduction
IEC61000-4-6
RF radiation
IEC61000-4-3
150 kHz~80 MHz
3 V/m
80 MHz~2.5 GHz
applicable
3 V/m
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 survey c, should be
less than the compliance level in each
frequency range d.
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.
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-EFT ThermArt is used exceeds the applicable RF
compliance level above, the IR-EFT ThermArt 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-EFT Infrared Forehead and Ear Thermometer.
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-EFT Infrared Forehead and Ear Thermometer
IR-EFT ThermArt 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

15
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 d in meters (m) can be determined using the formula applicable to the frequency of the
transmitter, where P is 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.
Declaration of Conformity
The IR-EFT ThermArt meets requirements established in ASTM E 1965 for the thermometer
system. And Comper Chuangxiang （Beijing）Technology Co., Ltd (Add: Room 102,103 1st Floor,
Building 4,No.1 Kangding Street, Beijing Economic Technology Development Area, Beijing,
100176, China) take full responsibility for the conformance of the thermometer to the standard.
The IR-EFT ThermArt 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

16
and tests.
ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels, labeling 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.
Warranty Information
From the date of purchasing the thermometer, you can enjoy the following after-sales services
provided by Comper with the purchase invoice: One-year Warranty.
Limitations
This warranty covers all defects encountered in normal use of the equipment and does not apply in
the following cases.
1. If the equipment has been serviced by other than a certified center.
2. Damage to the equipment due to mishandling, abuse, accident or not following operating
instruction.
3. Damage to the equipment due to wrong matainance.
4. Damage or failure caused by careless drop in the process of handling
5. Warranty does not extend to ear probe covers and batteries.
If you have any questions or comments on our product, please email to [e-mail].
Manufacturered by: Comper Chuangxiang（Beijing）Technology Co., Ltd
Address : Room 102,103 - F1, Room 203,213 - F2, Building 4, No. 1 Kangding Street,
Beijing Economic-Technological Development Area,
Beijing 100176, China
Contact Phone: [phone]

17
Federal Communications Commission (FCC) 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.
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.

18
Copyright Statement
The copyright is reserved by Comper Chuangxiang（Beijing）Technology Co., Ltd, which enjoys
and retains all the exclusive rights of copyright according to law. No part of this document may be
modified, excerpted, reproduced, or otherwise, in any form without prior written permission of the
company.
Regarding the contents of this document, the company assumes no express or implied warranties
or guarantees. The company reserves the power of interpretation for any changes arising from
product improvement and technological updating.