LUVION HTD8813 EXACT-80 Non-Contact Infrared Thermometer Instruction Manual

LUVION HTD8813 EXACT-80 Non-Contact Infrared Thermometer

EXPLANATION OF SYMBOLS

Non-sterile packaging

LOT number

Serial number

Manufacturer

Date of manufacture

This product must not be disposed of together with domestic waste.

CE symbol (conformity symbol)

Operating temperature

Operating humidity

Operating atmospheric pressure

Authorized Representative in the European community

Refer to instruction manual recommended

PACKAGE CONTENTS

• Luvion Exact-80 non-contact body thermometer
• 2 batteries 1.5V (type AAA/LR03 )
• This Instruction manual

PRODUCT OVERVIEW

Luvion non-contact Exact infrared body thermometer (Fig. 1)

1. Backlight LCD

2. Battery compartment

3. ON-button (Start of measurement)

4. SET-button

5. MEMO-button

6. MODE-button

7. IR Sensor
   Display (Fig. 2)

8. Surface temperature measurement mode

9. Body temperature measurement mode

10. Measurement result

11. Indicator of measurement result

12. Low battery indicator

13. Acoustic signal symbol

14. Memory display

15. Measurement unit: ° Fahrenheit

16. Measurement unit: ° Celsius

17. Memory indicator

INTRODUCTION

Thank you for purchasing the Luvion Exact-80 non-contact infrared body thermometer. Make sure you always keep your original proof of purchase. For warranty cases you will always be asked to show a copy of your proof of purchase. For warranty claims you can contact the Luvion dealer or the local Luvion representative. More information can be found at www.luvion.com
This manual contains all the information you need, to be able to use this Luvion Exact-80 Noncontact infrared thermometer safely and with pleasure. Before using the thermometer, we recommend that you read this instruction manual carefully. We ask for your extra attention for the safety instructions. Keep the instruction manual for future use. Should you give this device to another person, it is vital that you also pass on this instruction manual for use. This Non-contact Infrared Body Thermometer is a medical device and can be used repeatedly and has a 5-year life expectancy.

INTENDED USE
The Luvion Exact-80 non-contact infrared body thermometer is designed to be used for intermittent measurement and monitoring of human body temperature by consumers in the home setting and primary care setting as screening tool. Additionally the device is suitable to measure
the temperature of objects in the range of 0°C to 100°C (32°F – 212°F).

SAFETY INFORMATION

• Only use the unit for the specific purpose described in the instruction manual. Any misuse will void the warranty.
• The unit is not designed for commercial use.
• Using this thermometer is no substitute for consulting a doctor.
• This product is designed to measure human body temperature on the forehead. Do not use it for any other purpose.
• Do not use the thermometer if it malfunctions or has been damaged in any matter.
• This product must be operated in a stable environment. If the ambient conditions are changeable, the sensor may mist up, causing an incorrect measurement. Clean the sensor according to the section „Care and Storage“.
• When the ambient temperature of the thermometer changes too much, such as moving the Thermometer from one place of lower temperature to another place of higher temperature, allow the thermometer to remain in a room for 30 minutes where the temperature is between 15°C to 40°C (59°F- 104°F).
• Remove batteries if equipment is not likely to be used for long time.
• This product is not waterproof, do not immerse in water or other liquid; for cleaning and disinfection, please follow the „Care and Storage“ section requirements.
• Do not touch the IR sensor with your fingers.
•  Avoid taking fever measurements if measures have been taken beforehand to cool the user (e.g. cold forehead compresses, etc.)
• For the measurement of human forehead temperature, select „body“ mode; for measuring other objects, liquids, food and other temperatures, select „surface“ mode.
• Do not use near-strong electrostatic or magnetic elds to avoid inaccurate measurement results.
• It may aect the accuracy of measurements when the forehead is covered by hair, perspiration, cap or scarf.
• Children must be supervised to ensure that they do not play with the device.
• The temperature in the forehead and temple area diers from the internal temperature, which is taken orally or rectally. Vasoconstriction, an effect which constricts the blood vessels and cools the skin, can occur during the early stages of a fever. In this case, the temperature measured by this thermometer may be unusually low. If the measurement therefore does not match the patient’s own perception or is unusually low, repeat the measurement every 15 minutes. As a reference, you can also measure the internal body temperature using a conventional oral or rectal thermometer. A control measurement using a conventional thermometer is recommended in the following cases:
  1. If the reading is surprisingly low,
  2. For new-born infants up to 100 days old,
  3.  For children under three years of age who have a weakened immune system or who react unusually in the presence or absence of fever,
  4. If you are using the thermometer for the first time or want to familiarise yourself with it.
• Babies’ skin reacts very quickly to the ambient temperature. Therefore, do not take their temperature with this thermometer during or after breastfeeding, because the skin temperature may then be lower than the internal body temperature.
• The device should be kept out of the reach of children/pets.
• When not in use, store the device in a dry room and protect it against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the device.
• This thermometer will not replace diagnostics in hospitals.
• Do not disassemble or modify the device. Do not let it fall down.
• Do not use this device if you think it is damaged or if you notice anything unusual.The continuous use of a damaged unit may cause injury, improper results or other serious dangers.
• This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in the „Technical Specifications“ section.
• No servicing/maintenance while the thermometer is in use.
• Never touch batteries and the patient simultaneously.
• Based on the current science and technology, no potential allergic reactions are known.
• This equipment needs to be installed and put into service in accordance with the information provided in this instruction manual.

BATTERY SAFETY INFORMATION

• Do not disassemble batteries!
• Clean the battery and device contacts if necessary before putting in the batteries!
• Remove discharged batteries from the device immediately!
• Do not use rechargeable batteries!
• Increased risk of leakage, avoid contact with skin, eyes and mucous membranes! If battery acid comes in contact with any of these parts, rinse the affected area with copious amounts of fresh water and seek medical attention immediately!
• If a battery has been swallowed seek medical attention immediately!
• Insert the batteries correctly, observing the polarity!
• Keep the battery compartment well sealed!
• Remove the batteries from the device if it is not going to be used for an extended period!
• Keep batteries out of children‘s reach!
• Do not attempt to recharge the batteries! There is a danger of explosion!
• Do not short-circuit! There is a danger of explosion!
• Do not throw into are! There is a danger of explosion!
• Keep unused batteries in their packaging away from metal objects in order to prevent short circuiting!

OPERATION

General notes
The ambient temperature should be stable. Keep device away from the larger fllow fans, direct sunlight, air-conditioning vents and so on. Wait at least 30 seconds between each measurement.
If for some reason the forehead temperature measurement cannot be realized, try to align behind the ears.

Setting the measuring mode
When the device is running, pressing the MODE-button (6) to switch between „body“ mode and „surface“ mode. „Body“ mode is used for measuring human body temperature, the „Surface mode“ is used to measure the surface temperature (the factory default is „body“ mode).

Perform fever measurement

1. Turn on the thermometer by pressing the ON-button (3). The thermometer will perform a self-test with all segments displayed for 2 seconds.

2. Immediately align the thermometer with the middle of the forehead to measure body temperature (between the eyebrows) and keep a distance of 1 – 5 cm. Alternatively you may use an alignment behind the ears. After measurement, a sound will be emitted and the temperature will be displayed. If you hear three beeps, the measurement was not successful. Press the ON-button (3) again and repeat the measurement.

3. Depending on the measured body temperature the backlight LCD display will change the colors:
   Green means normal temperature (35.5°C- 37.3°C / 95.9°F-99.1°F), yellow means slight fever (37.4°C-38.0°C / 99.3°F-100.4°F), red means high fever (38.1°C-43.0°C / 100.6°F-109.4°F).
   Perform surface measurement

4. Turn on the thermometer by pressing the ON button (3). The thermometer will perform a self-test with all segments displayed for 2 seconds.

5. Aim the sensor at the center of the object at a distance of min. 5 to max. 15 cm. If it is covered with water, dust or dirt, remove this rst to optimize the measurement result.

6. In surface mode the backlight is always green.
   Recalling and erasing memory data
   The last temperature taken before the thermometer powers of is automatically stored in memory (max. 50 results). With the unit switched o, press the MEMO button (5) to call up the values stored in memory. If not all 50 memory locations are occupied, „—°C“ or „—°F“ may appear. If you press and hold the MEMO button (5) for about 2 seconds during the memory
   display, „CLR“ appears in the display and the stored data is deleted. In addition, an acoustic signal sounds.

Parameter settings
The device allows some individual settings (F1 to F3): Press and hold the SET- button (4) when the instrument is switched on to modify these settings.

• F1: Measurement unit. °C or °F.
• F2: Fever alarm temperature
• F3: Sound on/off

Press the MODE-button (6) or the MEMO-button (5) to adjust the value and the SET-button (4) to confrm and proceed to the next setting (after F3 the setting mode is completed).

Restoring the factory settings
With the device switched on, press and hold the MODE-button (6) until „rst“ appears on the display. 2 seconds later the factory settings for parameters F1 to F3 are restored (F1=°C; F2=38.1°C; F3=on).

Care and Storage

• The IR sensor 7 is the most delicate part of the medisana infrared body thermometer
  TM A79. Protect it from dirt and damage. Clean the sensor with a cotton bud dipped in warm water or 70% isopropyl alcohol.

• Use a clean, soft cloth to clean the surface of the unit and the display. Do not use solvents or immerse the product in water or other liquids.

• Always keep the thermometer within the storage temperature range (- 20°C – +55°C or -4°F – +131°F) and humidity range (93%, non-condensing).

• It is recommended to store the thermometer in a dry, dust-free place. Do not expose the thermometer to direct sunlight, high temperature/humidity or extreme environments, as this may affect its function.

WHAT IS FEVER?

• Body temperature varies from person to person and fuctuates during the course of the day. For this reason, it is suggested to know one‘s normal, healthy forehead temperature to correctly determine the temperature.
• Body temperature runs approximately from 35.5°C to 37.8°C (95.9°F-100°F). To determine if one has a fever, compare the temperature detected with the person‘s normal temperature. A rise over the reference body temperature of 1°C (1°F) or more is generally indication of fever.
• Different measurement sites (rectal, axillary, oral, frontal, auricular) will provide different readings. Therefore it is wrong to compare the measurement taken from different sites.
• Here below are typical temperatures for adults, based on different measurement sites:
  • Rectal: 36.6°C – 38°C / 97.9°F – 100.4°F
  • Axillary: 34.7°C – 37.3°C / 94.5°F – 99.1°F

ERROR MESSAGES

If the problems cannot be solved with these instructions or other problems occur, please contact the customer service.

DISPOSAL
This product must not be disposed of together with domestic waste. All users are obliged to hand in all electrical or electronic devices, regardless of whether or not they contain toxic substances, at a municipal or commercial collection point so that they can be disposed of in an environmentally acceptable manner.
Please remove the batteries before disposing of the device/unit. Do not dispose of old batteries with your household waste, but at a battery collection station at a recycling site or in a shop. Consult your municipal authority or your supplier for information about disposal.

BATTERY REPLACEMENT

If the low battery indicator (12) or nothing appears in the LCD display (1) after a certain period of use, you must replace the batteries with two new 1 .5V-batteries (type AAA / LR03).

1. Slide the lid of the battery compartment cover downwards and take the cover off .
2. Take out the batteries.
3. Put in two new 1.5V-batteries (AAA / LR03). Make sure the batteries are the right way around.
4. Put the battery compartment cover back on and move it upwards until it locks into position.

TECHNICAL SPECIFICATIONS

• Display system: Digital display (LCD)

• Power supply: 3 V , 2 x AAA-batteries 1.5 V

• Output range: Body mode: 34.0°C-43.0°C (93.2°F-109.4°F)

• Surface mode: 0°C-100°C (32°F-212°F)

• Laboratory accuracy: Body mode:

• (laboratory readings) 34.0°C- 34.9°C: ±0.3°C / 93.2°F-94.8°F: ±0.5°F
  35.0°C- 42.0°C: ±0.2°C / 95.0°F-107.6°F: ±0.4°F
  42.1°C- 43.0°C: ±0.3°C / 107.8°F-109.4°F: ±0.5°F

• Surface mode: ±2°C (±3.6°F)

• Display resolution: 0.1°C/0.1°F

• Measuring time:  2 seconds

• Measuring distance: 1-5 cm

• Reference body site: Axillary

• Memory capacity: Up to 50 measurement results

• Automatic switch-off:  18 seconds

• Battery life: approx. 2.000 measurements

• Operating temperature: 15°C to 40°C (59°F – 104°F), relative humidity: 85%,

• Storage/ atmospheric pressure: 70-106 kPa transport temperature: -20°C to 55°C (-4°F – 131°F), relative humidity: 93%,atmospheric pressure: 70-106 kPa

• Dimensions: approx. 138 x 95 x 40 mm

• Weight: approx. 90g without batteries

Compliance

Item:| Compliant with:
Equipment classification| Safety Standards: EN 60601-1: 2006+A1:2013, EN 60601-1-2: 2015
Type of protection| Internally powered equipment (on battery power)
Degree of protection| Non Applied part
Front panel and case labeling| EN ISO15223-1:2016
Temperature| EN ISO80601-2-56:2017
Home healthcare environment| EN 60601-1-11:2015

Calculated values of the indicators according to ISO 80601-2-5

Forehead mode:

-0.042| Group A1| Group A2| Group B| Group C
Bias| 0.015| 0.000| -0.042| -0.040
Standard Deviation| 0.123| 0.121| 0.121| 0.137
Limits of Agreement| 0.245| 0.243| 0.243| 0.274
Clinical Repeatability (for All Group)| 0.071

Note: the above value is calculated from clinical data of HTD8818A.

Safety classification of ME EQUIPMENT

Protection against electric shock| Internally powered ME equipment
Applied part| Non Applied part
Protection against harmful ingress of water or particulate matter| IP22
Mode of operation| Continuous operation

Note: Not intended to be sterilized. Not for use in an OXYGEN RICH ENVIRONMENT

EMC Declaration

1. This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS;
   This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment.

2. Caution: Do not use a mobile phone or other devices that emit electromagnetic eld, near the unit. This may result in incorrect operation of the unit.

3. Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation!

4. Caution: this machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used.

Guidance and manufacture’s declaration – electromagnetic emission

The Infrared Body Thermometer is intended for use in the electromagnetic environment speci- fied below. The customer of the user of theInfrared Body Thermometer should assure that it is used in such an environment.
Emission test| Compliance
RF emissions CISPR 11| Group 1
RF emission CISPR 11| Class B
Harmonic emissions IEC 61000-3-2| Not applicable
Voltage fluctuations/ flicker emissions IEC 61000-3-3| Not applicable
Guidance and manufacture’s declaration – electromagnetic immunity

The Infrared Body Thermometeris intended for use in the electromagnetic environment specified below. The customer or the user of Infrared Body Thermometer should assure that it is used in such an environment.
Anti-interference detection| IEC 60601-1 test level| Compliance level
Electrostatic discharge (ESD) IEC 61000-4-2| Contact: ±8 KV

Air: ±2, ±4, ±8, ±15 KV

| Same as the left
Electrical fast transient/burst IEC 61000-4-4| The input a.c. power ports: ±2 KV The input d.c. power ports: ±2 KV Signal input/output ports: ±1 KV|

Not applicable

Surge

IEC 61000-4-5

| Input power ports: +0.5, +1.0 KV Signal input/output:+2.0 KV
Voltage dips IEC 61000-4-11| 0.5 cycles for > 95% (sync angle (degrees):0, 45, 90, 135, 180,225, 270, 315)

1 cycles for >95% UT (sync angle (degrees):0)

Voltage interruption IEC 61000-4-11| 250 (50Hz)/300 (60Hz) cycles for

95% UT (sync angle (degrees):0)

Power frequency (50Hz/60Hz) magnetic field IEC 61000-4-8| 30A/m| Same as the left
NOTE UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacture’s declaration – electromagnetic immunity

The Infrared Body Thermometer is intended for use in the electromagnetic environment specified below. The customer or the user ofthe Infrared Body Thermometer should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level
Conducted RF IEC 61000-4-6| 3 Vrms

150 kHz to 80 MHz

| Not applicable
Radiated RF IEC 61000-4-3| Professional healthcare environment: 3 V/m| Same as the left.
| Home healthcare environ-|
| ment: 10 Vm

80 MHz to 2700 MHz

|
NOTE 1  At 80 MHz and 800 MHz, 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 landmobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoreticallywith accuracy. To assess the electromag- netic environment due to fixed RF transmitters, an electromagnetic sitesurvey should

be considered. If the measured field strength in the location in which theInfrared Body Thermometer is used exceeds the applicable RF compliance level above, the Infrared Body Thermometer shouldbe observed to verify normal operation. If abnormal performance

is observed, additional measures may benecessary, such as re-orienting or relocating the Infrared Body Thermometer.

b)   Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

In accordance with our policy of continual product improvement, we reserve the right to make technical and optical changes without notice.
The current version of this instruction manual can be found under www.luvion.com

The CE marking of the device refers to the EU Directive 93/42/EEC. The device is designed for domestic use. The thermometer is initially calibrated at the time of manufacture. If this thermometer is used according to the instruction manual, periodic re-adjustment is not required. If you should question the accuracy of temperature measurements, please contact the service center.
Hetaida Technology Co., Ltd.
4F,5F,6F, Comprehensive Building, Baishida High-Tech Park, Ailingkan Village,
Dalingshan Town, Dongguan City, Guangdong Province, P.R. China.
Share Info Consultant Service LLC
Repräsentanzbüro, Heerdter Lohweg 83, 40549 Düsseldorf
Tel: 0049 1767 0057022, Fax: 0049 1767 0057022
E-mail: [email protected]; info@share- info.cn; will.chan@share- info.cn

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