Lorelli Non Contact IR Thermometer for Body and Surface Instruction Manual

Non-Contact IR Thermometer for Body and Surface
Instruction Manual

Non-Contact IR Thermometer for Body and Surface

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INTRODUCTION

Thank you for buying this non-contact forehead infrared thermometer. Please read very carefully this instruction before using the device because the correct use is of critical significance for the accurate measurement of temperature. This thermometer is carefully designed for accurate, safe, and fast measurement of the body temperature on the forehead. Following the guidance in this instruction will make the thermometer user-friendly. The forehead temperature is the same as the subcutaneous good flow. This is good for checking the body temperature because measuring is not compromised by external factors and delays like measuring by the oral and rectal methods.

PRECAUTIONS AND SAFETY MEASURES

1. Sweat on the forehead may result in incorrect values. Before measurement, please ensure that the forehead is clean. If you have cleaned the forehead, wait 5 – 10 minutes before measuring the temperature.

2. Do not touch or blow over the infrared sensor. The contamination of the infrared sensor may result in incorrect readings. Cleans the sensor if you think that it might be contaminated. Cleans the sensor carefully with a cotton earbud soaked in spirit and then dries it with a dry and clean pad. Wait at least 20 minutes after cleaning before you start measuring it.

3. To achieve correct measurements, it is important to keep the probe clean and without scratches. Finger stains and dirt will affect the accuracy of the thermometer. To achieve accurate measurements, keep the probe’s tip clean. After cleaning, place the thermometer in a dry place at room temperature. Do not expose the thermometer to extreme temperatures, moisture, or direct sunlight. Protect it from dropping and impacts.

4. ATTENTION! Do not service and repair the device while in use.

5. This device is not life-supporting.

6. The use of this thermometer does not replace the professional consultation with your family doctor. Measurements are used only for reference. Consult your doctor if you have any doubts about your health status.

7. If the ambient temperature in the storage room considerably differs from the ambient temperature at the place where the measurement will be made, wait a while so that the temperature of the thermometer becomes equal to the ambient temperature. In case of big differences in the ambient temperatures,
   condition the thermometer for about 30 minutes before use.

8. Appropriate to be used at home conditions.

9. Keep the thermometer away from children and pets to avoid ingestion or inhalation of small parts. Do not allow children to measure temperature unattended. Children may not be capable to use the device in compliance with the instruction for use. This thermometer is not a toy.

10. Do not store the thermometer under extreme temperatures (below -13°F /-25°and above 131 °F/55°C) or under extreme moisture (Rh>90%). The thermometer under these extreme conditions may be inaccurate.

11. Do not use the thermometer if it is damaged in any way (for example – a broken infrared sensor). Continuous use of a damaged device may cause injury, incorrect readings, or serious hazards.

12. Do not disassemble, repair or replace any parts of the device except change of batteries.

13. Do not use a mobile phone near the thermometer while making measurements.

14. If the thermometer will not be used for a longer period, remove the batteries to prevent possible damage caused by chemical leakage. In case of leakage from the battery, carefully remove them.

15. In case of any leakage from the batteries, protect your skin. If this happens during use, do not touch the patient and the batteries simultaneously.

16. This device will not cause allergic reactions or irritation during normal use. However, if you experience any allergic reactions to any material, stop using the thermometer and consult your doctor.

17. Store the thermometer in a dry and clean place. Do not expose the product to any chemical solvents, dust, moss, direct sunlight, or high temperatures.

18. Do not store the thermometer together with objects with sharp edges.

19. Do not touch wounds, or skin affected by any skin disease or trauma with the sensor of the thermometer.

20. It is not advisable that the thermometer is used by patients that have been treated with anti-inflammatory drugs for their skin, to place the sensor of the thermometer on skin exposed to direct sunlight, heated by a source of heat, exposed to direct flow of an air-conditioner and by patients treated with a cold compress.

21. If the following conditions are available, it is recommended that the temperature is measured at least three times and to use the highest measured value: – newborn babies under three months.
    – children under the age of three years with an impaired immune system.
    – if you use the infrared thermometer for the first time.

22. The thermometer is not appropriate for sterilization. Do not use it in OXYGEN SATURATED ENVIRONMENT!

23. Please notify us of any unexpected situations.

24. After dropping, impact, or other circumstances that may affect the readings, please refer to a service center.

25. This device shall be serviced, repaired, and opened only at authorized service centers.

26. This thermometer is not intended for preterm babies.

( PRODUCT DESCRIPTION )

Principle of operation of the thermometer – the temperature sensor collects the infrared energy emitted by the skin surface. Once it is focused by a lens, energy is transformed into a temperature reading by the measuring chains.
Body temperature – the normal body temperature varies within certain limits. The trend is that the normal temperature decreases with aging. The table below shows the normal temperature ranges depending on age.

The normal temperature range varies among people and can be influenced by many factors such as the time of the day, measuring at different places, level of activity, drugs, emotions, etc. We advise you to practice measuring the temperature on yourself and your family members when in good health. Thus you will learn how to use the thermometer and will feel more confident when measuring the temperature of the same people when they feel sick.
Features – Non-contact design, safe, and more hygienic to use. Fast measuring, for less than 1 second. Accurate and reliable. User-friendly, single-button design. Multifunctional, capable of measuring forehead, room, milk, water, and object temperature. Memory function for 35 values, easy to retrieve. Switching between unmute and mute mode. Function for high temperature, shown in orange and red light. Switching between °C and °F. Automatic switch off and energy saving.
Measuring the forehead temperature – press the button for measuring to switch on the thermometer directed to the forehead at a distance of 0 – 3 cm. Skin contact is not necessary. When the button for measuring the body temperature is pressed, a sound is issued and then you may see the reading on the display. Holding the thermometer too long in the hand before measuring may result in the warming of the device. It means that measuring can be incorrect.
NOTE: The forehead measurement is indicative. The forehead temperature may vary upwards to 1 ° F / 0,5 ° C from your actual body temperature. Please consider the factors that affect accuracy as it is described in the instruction. If the eyebrows area is covered with hair, sweat, or dirt, please clean it to improve the measuring accuracy. Always ensure that the sensor is clean. Always ensure that the user and the thermometer were in the same room before measuring.
Product Description

1. LCD
2. Measuring button
3. Memory button
4. Mute button (or °C/°F switching)
5. Sensor
6. Batteries cover

Description of the display

1. Temperature value
2. Object temperature mode
3. Forehead temperature mode
4. Fahrenheit/ Celsius degrees
5. Battery level
6. Recalling values from memory
7. Unmute mute

Measuring object temperature – When the thermometer is switched off, press the Mem button for 3 seconds. Then press the room or object measuring button. Keep the thermometer at a distance of 1.3 cm from the object. Press and release the measuring button for 1 second and when you hear the sound signal, you may see the reading.
Readings -“T” shows measuring temperature in forehead mode.

1. If 32°C 575 37.3°C (89.6°F 5T 5 99.2°F), the green light will stay for 12 seconds, with a single long sound signal.
2. If 37,4°C 5 T 5 37,9°C (99,3°F 5 T 100,3°F), the orange light will stay for 12 seconds, with 3 short sound signals, and the value on the LCD will blink, which is a warning that you have a mild fever.
3. If 38°C 5 T 542,9°C (100,4°F sT 109,2°F), the red light will stay for 12 seconds, with 5 short sound signals, and the value on the LCD will blink, which is a warning that you have a high temperature.

Switching between unmute and mute mode -when the thermometer is switched on, press the mute button and then again unmute.
Check the 35 data sets from the memory – when the thermometer is switched on, press the Mem button to enter the memory mode, and press again that button to check the 35 data sets one by one. If no values are available, it will show”— M”.
°C / °F conversion – when the thermometer is switched on, the continuous pressing of the mute button for 5 seconds will switch “Cl °F.
Temperature compensation setting – when the thermometer is switched on, press simultaneously the mute button and the Mem button for 2-3 seconds to enter temperature compensation mode. Temperature adjustment from ± 0,0 to 2,0 is made by pressing the Mem button.
Note: All future temperatures, which you will measure, will be automatically added to the value that you have set.
Switching off – the device will be automatically switched off when idle for 10 seconds. Or by pressing the measuring button continuously for 6 seconds. Attention:

1. AII values from the memory will be reset when you remove the batteries.
2. All settings will be set to default when you remove batteries. If you have to adjust the settings, please switch them on and make the new settings.

Channing batteries – slide the cover of the batteries in the indicated direction. Place correctly two batteries AM in the department. Remove the batteries if you will not use the thermometer for more than two months.
Attention: Under certain conditions, batteries may leak and this may cause chemical burning or damage to the device. If the leakage from the batteries contacts the skin or the eyes, immediately flush with plenty of water. Batteries must be handled under the supervision of an adult. Dispose of the used batteries with due care. Do not disassemble, recharge or throw batteries in a fire. The battery may explode with flames. The use of alkaline batteries is recommended. Keep the batteries out of the reach of children. Do not mix old and new batteries or batteries of a different type.
Disposal and recycling – Batteries contain substances that are harmful to the environment. Do not throw the batteries together with ordinary household waste but deliver them to a specialized place for collecting batteries. Always remove the battery before disposal of the device or delivering it to an official waste collection point. IMPORTANT! After the end of the service life of the device, do not dispose of it together with ordinary household waste but deliver it to an official collection point for recycling. Thus you will help with environmental protection.

Care and cleaning – use a pad soaked with spirit or cotton pad, soaked in 95% alcohol to clean the case of the thermometer and the measuring sensor. Once the alcohol fully dries, you can measure again. Ensure that no liquid enters the thermometer. Do not use abrasive cleaning agents, solvents, or benzene for cleaning, and never soak the device in water or other cleaning liquids. Be careful and avoid scratching the surface of the LCD.
Guarantee and after-sales service – all damages caused by incorrect use as a result of non-observance of the instructions in the operations manual will not be covered by the guarantee.
Electromagnetic compatibility (EMC)

1. This product needs special precautions concerning EMC and must be installed and operated in compliance with the provided information about EMC and this device can be affected by portable and mobile radio communication equipment.
2. Do not use mobile telephones or other devices, which create electromagnetic fields near the device. This may cause faulty operation of the device.
3. Attention: This device has been thoroughly tested and inspected to ensure its correct functioning and operation!
4. Attention: This thermometer shall not be used next to or in contact with other equipment. If the equipment must remain in immediate proximity to the used thermometer, it shall be monitored to confirm normal operation during measurement.

By increasing the number of electronic devices, such as computers and mobile telephones, the used medical devices may be affected by electronic disturbances from other devices. Electromagnetic disturbances may affect the correct operation of the medical device and create a potentially hazardous situation. Medical devices also shall not interfere with other devices. To regulate the EMC (electromagnetic compatibility) requirements to avoid situations with hazardous products, EN 60602-1-2 standard has been introduced. This standard determines the levels of protection against electromagnetic disturbances, as well as the maximum levels of electromagnetic emissions for medical devices. This medical device has been produced and complies with the standard EN60601-1-2 on protection and emissions.

right position
The thermometer is damaged| Contact Dealer
The reading is too low| The lens of the probe is dirty.| Clean the lens with a cotton swab.
The distance between the item and the target is too far| Ensure the thermometer measures the forehead center within 3cm.
You have just come from a cold environment| Stay in a warmer room for at least 30 minutes before taking a reading
The reading is too high| You have just come from a hot environment.| Stay in an adequately cool room for at least 30 minutes before taking a reading
| The ambient temperature is not in range.| 3 short beeps and red backlit for 3 seconds. Take a measurement under an ambient temperature between 15°C (59°F) and 35°C (95°F).
| Memory Error| 3 short beeps and red backlit for 3 seconds. Contact dealer.
| In forehead mode, T > 42.9°C (109.2°F)| 3 short beeps and red backlit for 3 seconds.
| In forehead mode, T < 32°C (89.6°F)| 3 short beeps and red backlit for 3 seconds.
| 2.5V±3%gpower voltage .2.6V±3%| The battery level is low, it suggests you replace the battery, but you can continue to use it.
| The power voltage is lower than 2.5V± 3%.| It will turn off automatically after 30 seconds. Please replace it with a new battery

Specifications

Object: 0°C-100°C (32°F-212°F)
Accuracy (Laboratory)| Forehead mode| ±0.2°C 1±0.4°F
Object mode| ±1.0°C/1.8°F
Display resolution| 0.1°C/°F
Measuring distance| 0-3cm
Automatic shutdown| 10s±1s
Memory| 35 groups of the measured temperature.
Operational conditions| Temperature: 15°C – 35°C (59°F-95°F) Humidity: 15-85%RH, non-condensing Atmospheric pressure: 70-106 kPa
Storage and transport conditions| RH 90% -25°C — 55°C (-13°F–131°F)
Battery| 2*AAA can be used more than 3000 times
Weight & Dimension| 66.8g (without battery), 36 x42 x153.5mm

Symbol

inhomogeneous substances
| IMPORTANT
Inaccurate readings or thermometer damage may occur if the thermometer is not correctly used.
| Waste electrical materials should be sent to a dedicated collection point for recycling.
| EU safety requirements
| Radiofrequency emitter symbol
| European authorized representative

EMC information

Guidance and manufacturer’s declaration-electromagnetic immunity
The infrared thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of the infrared thermometer should assure that it is used in such an environment.

Immunity test| IEC60601 test level| Compliance level| Electromagnetic environment -guidance
---|---|---|---
Electrostatic discharge
(ESD) IEC 61000-4-2| ±2, ±4, ±6,
±8kV for Contact discharge
±2,±4,
±8,±15kV
air discharge| ±2, ±4, ±6, ±8kV for Contact discharge ±2,±4,±8kV, ±15kV
air discharge| The floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%
Electrical fast transient/burst IEC 61000-4-4| ±2 kV for a.c. power lines ±1 kV for d.c. power lines| N/A| Mains power quality should be that of a typical commercial or hospital environment.
Surge
IEC 61000-4-5| ±1 kV line(s)
to the line(s)
±2 kV line(s) to earth| N/A| Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips, short
interruptions
and voltage variations in power supply input lines
IEC 61000-4-11| <5%UT (>95 dip inUT) for 0.5 cycle
40%UT
(60% dip inUT) for 5 cycles
70% UT
(30% dip in UT) for 25 cycles
<5(YOUT (>95% dip inUT for 5 s| N/A| Mains power quality should be that of a typical commercial or hospital environment. If the user of the infrared thermometer requires continued operation during power mains interruptions, it is recommended that the infrared thermometer be powered by an uninterrupted power supply or a battery
Power frequency (50/60Hz) magnetic field IEC 61000-4-8| 3 A/m| 3 Alm| Power frequency magnetic fields should be at levels 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 level.
Guidance and manufacturer’s declaration-electromagnetic immunity

The infrared thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of the infrared thermometer should assure that it is used in such an environment.
Immunity y test| IEC 60601 test level| Compliance level| Electromagnetic environment- guidance
Conduct
d RF
IEC
61000-4-6| 3Vrms 150kHz to 80MHz| N/A| Portable and mobile RF
communications equipment should be used no closer to any part of the infrared thermometer including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d=1.2 P
Radiated RF
IEC
61000-4-3| 3V/m
80kHz to 2.5GHz| 3V/m| d=1.2 P 80MHz to 800MHz
d=2.3 P 800MHz to 2.5MHz
Here P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m). Field strengths from fixed RF transmitters,
as determined by an electromagnetic site survey, should be less than the compliance b level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 90MHz and 800MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
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 broadcasts,s and TV broadcasts cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the thermometer is used exceeds the applicable RF compliance level above, the thermometer should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the thermometer.
b) Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.

Recommended separation distances between portable and mobile RF communications equipment and the infrared thermometer
The infrared thermometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the infrared thermometer can help prevent electromagnetic interference by maintaining a maximum distance between portable and mobile RF  communications equipment (transmitters) and the infrared thermometer as recommended below, according to the maximum output power of the communications equipment.

The rated maximum output power of transmitter W| Separation distance according to the frequency of
transmitter m
---|---
Rated maximum output power80MHz
of transmitter W| 150kHz to
d =1.2 P| 80MHz to
800MHz
d =1.2 P| 800MHz to 2.5GHz
d =2.3 P
0.01 0.01| 0.12| 0.23
0.1 0.1| 0.38| 0.73
11| 1.| 2.
1010| 4.| 7.
100100| 12| 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where Pis the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
Guidance and manufacturer’s declaration-electromagnetic emissions
The infrared thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of the infrared thermometer should assure that it is used in such an environment.

Emissions test| Compliance| Electromagnetic environment- guidance
---|---|---
RF emissions
CISPR 11| Group 1| The infrared thermometer uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not
likely to cause interference in nearby electronic equipment.
RF emissions
CISPR 11| Class B| The infrared thermometer is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply
Harmonic emissions
IEC 61000-3-2| N/A
Voltage fluctuations /flicker emissions IEC| N/A| a network that supplies buildings used for domestic purposes.

Designated by
www.zlg.de
ZLG-BS-244.10.08https://sce.tuv-sud.com/sce?id=8DWU2
EC Certificate
Production Quality Assurance System
Directive 93/42/EEC on Medical Devices (MDD), Annex V (Devices in Ciass Ila, IIb or II!)
No. G2 004665 0002 Rev. 01
Manufacturer: Shenzhen Finicare Co., Ltd
201, No. 50, the 3rd Industrial Park
Housing Community, Shajing Street
Bao’an District
518104 Shenzhen
PEOPLE’S REPUBLIC OF CHINA
Product Category(ies):
Infrared Thermometer
The Certification Body of TUV SUD Product Service GmbH declares that the aforementioned manufacturer has implemented a quality assurance system for the manufacture and final inspection of the respective devices/device categories in accordance with MDD Annex V. This quality assurance system conforms to the requirements of this Directive and is subject to periodical surveillance. For marketing of class Ib and Ill devices, an additional Annex Ill certificate is mandatory. All applicable requirements of the testing and certification regulation of TUV SUD Group have to be complied with.
For details and certificate, validity see: www.tuvsud.com/ps- cert?q=cert:G20046650002Rev.01
Report No.: GZ2036501
Valid from: 2020-11-05
Valid until: 2024-05-07
Date, 2020-11-05

Christoph Dicks
Head of Certification/Notified Body

Declaration of Compliance

Company Name: Shenzhen Finicare Co., Ltd, 201, No.5O, the 3rd Industrial Park, Housing Community, Shajing Street, Bao’an District, Shenzhen 518104, China Product Item No: FC-IR200
Description: Infrared Thermometer
For our model FC-IR200, delivered to DIDIS Ltd as 1025014 NON-CONTACT IR THERMOMETER FOR
BODY AND SURFACE:

1. We manufacturer hereby declare that the above model is compliant with the Restriction of Hazardous Substances in Electrical and Electronic Equipment Directive (ROHS 2.0) 2011/65/EU.
2. We hereby agree that only RoHS-compliant materials and components will be used in the assembly of the above model. Under no circumstances will non-compliant materials and components be used in place of approved compliant equivalents during the life of the product.
3. This device corresponds to the European directive MDD 93/42/EEC relating to medical devices, ISO 80601-2-56, and European standard EN 60601-1-2 and it is subject to specific precautions, regarding electromagnetic compatibility.

Manufacturer
Shenzhen Finicare Co., Ltd
201, No.50, the 3rd Industrial Park,
Housing Community, Shajing Street,
Bao’an District, Shenzhen 518104
China| Share Info Consultant
Service LLC Reprasentanzburo
Add: Heerdter Lohweg 83, 40549 Dusseldorf, DE
Dimdi Code: DE/0000047946| Importer:
Didis LTD, Bulgaria
Shumen 9700, Ne 6 Trakia-iztok street
Tel.: +359 54 850 830
e-mail: home.market@didis-Itd.com
e-mail: export@didis-Itd.com
---|---|---

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