measurement circuit magnifies the signal, after compensation Attention!

Attention! Please • Rechargeable battery is not allowed to use on the device. Only
TP500 conversion and correction by the processor, the measured refer to the Please refer to the
single-purpose battery can be used. Do not throw used batteries
Infrared temperature value will be displayed on the screen. The data measured
under Body-mode is estimated from the data measured under Obj-
A accompanying
document (the user
© manual booklet
into fire.
• The disposal of waste batteries should follow local
mode (calibration mode). The estimation method is based on the data manual) environmental protection regulations.
Thermometer measured under Obj-mode and the values obtained after 2.3 Button and parameter setting
CONTEC™
Contec Medical Systems Co., Ltd.
compensation conversion under different environments according to
statistical rules.
This device is suitable for body temperature measurement of adults,
a Battery
X Manufacturer
Button symbol: ”
1) In device off state, pressing the button could turn on the device,
Address:NO.l 12 Qinhuang West Street,
Economic & Technical Development Zone,
Qinhuangdao,Hebei Province, PEOPLE’S
children and neonates. It is recommended that the device be operated
by an adult.
Note: According to the difference of human skin and the parts of the
a Type BF applied part This way up and the device performs self-test, after self-test is completed, it
enters startup interface and makes a beep sound, if self-test fails,
it prompts for failure on the screen.
REPUBLIC OF CHINA
Tel: +86-335-8015430 Fax: +86-335-8015588
Technical support:+86-335-8015431 E-mail:
body to be measured, the measured temperature will be different,
which is normal. It is because that the more exposed body part is
more affected by the ambient temperature.
y
tr • J
Temperature limit
L-L j
Fragile, handle with care 2) In device on state, short press the button to start measuring.
3) In device on state, long press the button to enter review
interface.
1.2 Performance parameters r „ri Atmospheric pressure 4) In review interface, long press the button to enter parameter
[email protected] Website: • Safety class: internally powered equipment, type BF applied part Humidity limit V
0 cr J limit setting interface. In the setting interface, short press button to switch
http://www.contecmed.com CMS2.782.512ESS/1.0 1.4.01.11.159 • Degree of protection against ingress of liquid: IPXO L’ J items, when the cursor moves to the item to be set, long press the
2020.03 Gracias por comprar nuestro servicio Please read the User • Safety class: The device can not be used in the presence of a button to make it under selected state, then short press button to
Manual carefully before using this product. The operating mixture of flammable anesthetic gas with air or oxygen or rt
Use by date Keep away from rain adjust its parameter. After setting the parameters, long press the
procedures specified in this User Manual should be followed
strictly.
nitrous oxide.
• Operating mode: continuous running
X button to save and exit.
Parameters in the following can be set:
• Unit: °C/°F S
Copyright El Stacking limit by Material code by (D Sound prompt
• Resolution: 0.1 °C P/N
The user manual contains proprietary information, which is protected
by copyright. Photocopy, reproduction or translation of any part in
• Display range:32.0°C - 43.0 °C ■ number manufacturer (2) Unit: °C and °F
(3) Mode: User can switch the mode to “Obj” (calibration mode).
• Max. allowable error: r i This setting will not be saved, the device automatically enters
the manual without our company's written permission is prohibited. pA-4~|
35.0 °C-42.0 °C: ±0.2 °C Date of manufacture ILOTI Batch code “Body” mode after restart.
Our company owns the final explanation right to this user manual. L J
<35.0 °C or >42.0°C: ±0.3
Our company reserves the right to change the content of this user " * "Cl - «• -Ci ® H Memory - Set
°C
manual without prior Note. $ Bluetooth Serial number 36.5 °C Sound ON
• Max. allowable clinical repeatability: < ± 0.3 °C °C 01
Responsibility of the company 02 36.8 °C Unit °C
• Measurement time: < 1 s
Our company is only responsible for the safety, reliability and
performance of the device in the following conditions: the
• Display: LCD screen Waste disposal symbol. This symbol indicates that electrical ju, I
“in'-! 03
04
36.3
36.5
°C
°C
Mode
Calibrate
Body

• Memory: 30 groups of data K

and electronic equipment waste cannot be disposed of as
Body Body Return
installation and maintenance are performed by personnel approved
• Power management: Automatic shutdown when there is no
by our company, and the device is used in accordance with the unsorted municipal waste and must be recycled separately. Note: The body temperature is different from the skin
operation; battery level indication; low battery prompt
operating instructions. This item is compliant with Medical Device Directive temperature. In “Body” mode, the device measures the human
• Power supply: DC 3V (2 AAA batteries)
Warranty C € 0123 93/42/EEC of June 14, 1993, a directive of the European body temperature, and in “Object” mode, it measures the skin
• Date of manufacture: see the label
The device cannot be repaired by the user. All repairs should be
• Weight: about 130 g Economic Community. temperature. Please be sure to select the “Body” mode when
performed by a technician authorized by our company. As requested measuring body temperature.
• Normal working and storage condition: | EC |
European Representative.
by user, we will provide circuit diagrams, calibration methods and REP]
Temperature: Chapter 3 Measurement
other information after paid by user, to help to repair the parts of the
device classified as serviceable by qualified technicians. The
Working: 16 °C - 35 °C Transport and Chapter 2 Preparations before Measurement 3.1 Measurement steps
storage: -20°C - +55 °C 1) After turning on the device, align the detection hole to the center
warranty of this device covers all device failures caused by the failure
Humidity: 2.1 Appearance of the forehead (above the place between eyebrows) and keep
of materials or production procedures. During the warranty period,
Working: < 85 % (no condensation) 1) Infrared sensor vertical, the distance from the device to the forehead should be
all faulty parts can be repaired and replaced free of charge. Man-
Transport and storage: < 95 % (no condensation) 2) LCD screen less than 3 cm (do not directly touch the patient’s skin).
made damage is not covered by the warranty.
Atmospheric pressure: 3) Button
Explanation of notes in the user manual:
Working: 700 hPa - 1060 hPa Transport and 4) Battery cover
Zt\. Warning ZÍ\ It indicates the information that you should know
storage: 500 hPa - 1060 hPa
to avoid possible damage of patient and medical personal. A 1.3 Precautions 2.2 Installation of battery
Z!\ Caution Zh Following the direction in below figures, press down
Caution A It indicates the information that you should know to and slide the battery cover at the bottom of device to open it, install 2) Press the button to start measuring.
The service life of the device is 5 years. When the products described 3) After measuring, the temperature value will display on the
avoid possible damage of device. 2 AAA batteries, and close the battery cover. Pay attention to the
in this manual are about to expire, they must be disposed of in screen. If measuring unsuccessfully, “—” and corresponding
polarity symbols inside the battery compartment. The positive and
accordance with relevant treatment specifications. If you would like error reason will display on the screen.
ZÍ\ Note ZK It indicates the important information that you should further information, please contact our company or its representative. negative terminals of the battery cannot be reversed.
Figure 2 A Note A
know. ZK Note Zt\ • When the temperature measured exceeds the normal body
A Note ZI \ temperature, “Body Temp Lo” or “Body Temp Hi” displays on
Zt\ Waring Zl\ •
Contraindications: None.
•
Do not place the device near objects with charge to avoid • Please refer to the maintenance instructions for product the screen.
The device is not intended use for treatment purpose. electric shock. inspection before preparing for measurement. A Note A
• Do not use this device in an environment with relative humidity
Z?\ Warning Zt\ do not refit the device.
greater than 85%.
ZK Note ZÍ\ • The device should away from electromagnetic area (such as
radio, mobile phone, etc.).
If the hospital or institution using this device fails to implement a • Please do not expose the device to the sun or near the stove, or
satisfactory maintenance plan, it will cause abnormal device failure contact with water.
and may endanger human health. • Avoid impact or accidently falling, and do not use it if
Chapter 1 General it is damaged. • Before measuring,
1.1 Product composition and intended use 1.4 Accessories make sure that the
• Infrared Thermometer(l) Figure 1 Figure 3
Name: Infrared Thermometer measurement
Model: TP500 • User manual(l) • When the battery icon becomes I I, it indicates that the battery is position is not covered by hair, sweat, cosmetics or hat, and do
Composition: shell, circuit board, temp, measuring part, screen and • 2 AAA batteries (optional) about to run out, you can still continue the test, but please replace not measure on forehead with trauma, sweat, bangs, cooling
power supply. 1.5 Symbols 2 new batteries of the same model as soon as possible to avoid patch, cosmetics or scar. As it may cause an inaccurate
Application: to measure patient’s temperature on forehead. Your device may not have all symbols below. measurement.
The device adopts infrared temperature measurement technology, affecting normal use. • When the forehead temperature is influenced by environment
which can quickly measure the target temperature and performSymbol Description Symbol Description • If the device is not used for a long time, please remove the temperature or the forehead has sweat, please measure aiming at
intelligent analysis and processing. The measurement process is: the batteries to prevent battery leakage causing device damage. earlobe.
infrared sensor in the measurement part receives the infrared • Please pay attention to the polarity of the battery. Wrong
radiation energy of the human body or an object, and the installation may cause device damage.
 4.2 Cleaning environment specified below. The purchaser or the user of the Infrared Thermometer Table 4: Recommended separation distances
• When using the device, please pay attention to its cleaning to Recommended separation distances between portable and mobile RF
should assure that it is used in such environment.
avoid cross infection. communications equipment and the Infrared Thermometer
• When the surface of the device or the detector is contaminated,
IEC60601 Compliance Electromagnetic environment - The Infrared Thermometer is intended for use in the electromagnetic
wipe it with 75% medical alcohol cotton ball, then wipe with a Immunity test
test level level guidance environment in which radiated RF disturbances are controlled. The purchaser or
dry or soft cloth.
the user of the Infrared Thermometer can help prevent electromagnetic
ZK Warning , tk interference by maintaining a minimum distance between portable and mobile
The battery must be removed before cleaning the device. RF communications equipment (transmitters) and the Infrared Thermometer as
• The ambient temperature around the tester should be stable, do Electrostatic ±8kV
±8kV Floors should be wood, concrete or recommended below, according to the maximum output power of the
not measure in places with large air flow, such as fan, air- Zt\ Caution Zt\ discharge contact
contact communications equipment.
(ESD) ±15kV ceramic tile. If floor are covered
conditioning outlet, etc. • High-pressure sterilization cannot be used on the device. IEC 61000-4-2 air
±15kV air
• When the device is taken out from the place where has a large with synthetic material, the relative Separation distance according to power of transmitter (m)
• Do not immerse the device in liquid. Rated power of
difference with the use environment, it should be left in the use humidity should be at least 30 %.
environment for 30 minutes before measuring. • Do not use the device if any damage sign on temperature probe transmitter 80 MHz - 800
• Avoid using it when some cooling measures (such as cold or cable is found. Power (W) 150kHz - 80 MHz MHz 800 MHz - 2.7 GHz
Power frequency magnetic fields
compresses, sweating, etc.) are being taken on the feverish • If the device is dirty, wipe it with a soft and dry cloth. frequency (50 / d=0.58"//’ d=0.35'//’ d=0.7'//’
should be at levels characteristic of
forehead, as it may result in a lower result. • If the device is extremely dirty, wipe it with 75% medical alcohol 60Hz) magnetic 30A/m 3 OA/m 0.01 0.06 0.04 0.07
a typical location in a typical
• It is recommended to take three measurements per time, if the cotton ball, then dry thoroughly. field 0.1 0.18 0.11 0.22
commercial or hospital
three values are different, please take the highest value. The Ztk Warning ZI\ IEC 61000-4-8 1 0.58 0.35 0.7
measured results are only for reference, please do not diagnose environment.
Do not allow water to enter the device. 10 1.83 1.10 2.20
and treat by yourself based on the results, please go to hospital
ZL Warning Zt\ Table 3: Electromagnetic immunity 2 100 5.8 3.5 7
for treatment if necessary.
• When the ambient temperature has a great change, please do not Do not wipe the device with volatile oil, diluent or gasoline, etc. Guidance and manufacturer’s declaration - electromagnetic immunity For transmitters rated at a maximum output power not listed above, the
start measuring immediately. 4.3 Storage method The Infrared Thermometer is intended for use in the electromagnetic environment recommended separation distanced in meters (m) can be estimated using the
• Please keep 15 s interval between two continuous measurements, Ztz Warning A specified below. The purchaser or the user of the Infrared Thermometer should assure equation applicable to the frequency of the transmitter, where P is the maximum
one minute is recommended. output power rating of the transmitter in watts (W) according to the transmitter
that it is used in such environment.
• When measuring continuously for a long time, the measured Do not place the device in following places: manufacturer.
IEC Compl NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher
results may have a little deviation, which is normal. As when • Where is easy to be splashed by water. Immunity 60601 test iance
Electromagnetic environment -
holding the device, the temperature of hand affects the • Direct sunlight, high temperature, humidity and dusty places. test guidance frequency range applies.
level level
measurement for the device to the ambient temperature. So it is • Where is inclined or subject to vibration or knock. NOTE 2 These guidelines may not apply in all situations. Electromagnetic
recommended to leave the device away from your hand after • Where chemicals or corrosive gases are stored. propagation is affected by absorption and reflection from structures, objects and
measuring several times or not measure. people.
¡Chapter 5 Troubleshooting
3.2 Shutdown A Warning *
The device will shut down automatically when there is no operation. • Active medical devices are subject to special EMC precautions
and they must be installed and used in accordance with these
ZK Warning Zt\ guidelines. Portable and mobile RF
Please check whether the device and it accessories can work normally communication equipment should be • Electromagnetic fields can affect the performance of the device,
before use. During using, the following problems may appear, please find a solution used no closer to any part of the so other equipment used near the device must meet the
following the instructions below. If the problem exists still, ilease contact Infrared Thermometer including appropriate EMC requirements. Mobile phones, X-rays, or MRI
A Caution A cables, than the recommended devices are possible interference sources, as they emit high-
our customer service.
Please do not knock or drop the device during measuring. separation distance calculated from the intensity electromagnetic radiation.
Problem and reason Solution
Ztx Note Zt\
equation applicable to the frequency of • The use of ACCESSORIES, transducers and cables other than
the transmitter. those specified, with the exception of transducers and cables sold
Surface temperature is too low: it Make sure there is no obstructions when measuring.
Please use the device in required working and storage environments, Recommended separation distance: by the MANUFACTURER of the the device as replacement parts
or the result may not be measured or the measured result may be is affected by hair or sweat, etc. d=1.2 VP for internal components, may result in increased EMISSIONS or
inaccurate. Make sure the device is used within a measurable 10 V/m
Radiated RF 10 d=1.2 VP 80 MHZ-800 MHZ decreased IMMUNITY of the ME EQUIPMENT or ME
3.3 General knowledge of body temperature 80 MHz- 2.7
Surface temperature is too high. temperature range. IEC61000-4-3 V/m d=2.3 "/P 800 MHZ-2.5 GHZ Where SYSTEM.
GHz
The human body is a complex biological integrated system, and the Surface temperature is too low: P is the maximum output power rating • The machine should not be used adjacent to or stacked with
body temperature is an important data on judging whether the life Make sure to operate the device in accordance with of the transmitter in watts (W) other equipment and that if adjacent or stacked use is necessary,
the measurement
activities are normal, we usually check health condition by according to the transmitter it should be observed to verify normal operation in the
distance is too far. requirements, then measure again.
measuring the temperature on forehead, cochlea, anus, month and manufacturer and d is the configuration in which it will be used.
armpit, etc. The temperatures measured on different parts are recommended separation distance in • Devices or systems may still be interfered by other equipment,
different. Compared with the mercury thermometer, the clinical Low power / the device can not Check the battery polarities to make sure they are even if other equipment meets the requirements of the
meters (m).
repeatability for the device is less than ± 0.3 °C. be turned on. installed properly; Field strengths from fixed RF corresponding national standard.
The body temperature changes with the different time of the day, Low voltage, replace two new “AAA” batteries. transmitters, as determined by an • The device requires special precautions for electromagnetic
and it is also affected by other external conditions, such as age, electromagnetic site survey, a should be compatibility (EMC) and requires qualified personnel to install
gender, skin color and thickness, etc. We recommend to measure less than the compliance level in each and use in accordance with the EMC information provided below.
regularly under the following conditions:
.ppendix I EMC declaration
frequency range .b
• Measure with the same thermometer Table 1: Electromagnetic emission Interference may occur in the vicinity of
• Measure at the same place. Guidance and manufacture’s declaration -electromagnetic emission equipment marked with the following
• Measure at the same time every day. The Infrared Thermometer is intended for use in the electromagnetic environment symbol:
4.1 Maintenance and inspection specified below. The purchaser or the user of the device should assure that it is used («i») Certificate of
in such and environment. Compliance & Calibration
|Chapter 4 Maintenance Emission Compli NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2
MODEL __________________________
Please take the following inspections before using the device: test anee These guidelines may not apply in all situations. Electromagnetic propagation is
Electromagnetic environment - guidance DATE ____________________________
• Check whether there is any mechanical damage. affected by absorption and reflection from structures, objects and people.
The Infrared Thermometer uses RF energy only for its CERTIFIED BY
• Check whether the infrared detector has any damage. (Quality Inspector)
RF
• Check all functions of the device and make sure that the device is emissions Group 1
internal function. Therefore, its RF emissions are very
a Field strengths from fixed transmitters, such as base stations for radio
in good working condition. low and are not likely to cause any interference in nearby (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM This form certifies that the medical device listed above was inspected and
CISPR11
If any damage sign is found, please contact the qualified service electronic equipment. radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. calibrated in accordance with the published specifi cations of CONTEC
personnel. To assess the electromagnetic environment due to fixed RF transmitters, an MEDICAL SYSTEMS CO., LTD. The accuracy and calibration of the test
After every 6 ~ 12 months or maintenance, a comprehensive RF
The Infrared Thermometer is suitable for use in all electromagnetic site survey should be considered. If the measured field strength in instruments utilized are directly or indirectly traceable to the National
emissions Class B
inspection (including functions, safety and accuracy) to the device the location in which the Infrared Thermometer is used exceeds the applicable RF Metrological Verification System. This calibration program meets the
CISPR11 establishments, including domestic establishments.
must be carried out by the qualified personnel. compliance level above, the Infrared Thermometer should be observed to verify requirements of the Quality System Regulation, EN ISO 13485 «fe ISO 9001.
All inspections required to open the device must be performed by the normal operation. If abnormal performance is observed, additional measures may be
qualified service personnel. Safety and maintenance inspections can Table 2: Electromagnetic immunity 1 ____________________
Guidance and manufacture’s declaration-electromagnetic immunity necessary, such as reorienting or relocating the Infrared Thermometer.
also be performed by company personnel. Your local company office The Infrared Thermometer is intended for use in the electromagnetic b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3
will be happy to provide the information related to signing a V/m.
maintenance contract.