VEGA IR-08MT Non Contact Infrared Forehead Thermometer Instruction Manual

TECHNOLOGIES INC.
INSTRUCTION MANUAL
Non-contacted Infrared forehead thermometer
Model No.: IR-08MT
Revision: V1.0
Date of issue: 2022-7-22

Read this instruction manual carefully before use

Introduction

Thank you very much for purchasing our Non-contacted Infrared forehead thermometer IR-08MT.
To ensure safe and correct use of this device, please read this instruction manual carefully before using. We also recommend you to keep this manual at hand for future reference.
The Non-contacted Infrared forehead thermometer is intended for the intermittent measurement of human body temperature for people of all ages. It allows you quickly and easily to measure temperature, and values are saved automatically. The thermometer has been clinically tested and proven to be safe and accurate and no any side effects when used in accordance with the operating instruction manual.
Non-contacted Infrared forehead thermometer frontal temperature gun for measuring human body temperature. The product is widely used in schools, customs, hospitals, families. Easy to use, mode selection.
The Non-contacted Infrared forehead thermometer is intended for the intermittent measurement of human body temperature for people of all ages

Information about the device:

2-1. Intended use:
The Non-contacted Infrared forehead thermometer is intended for the intermittent measurement of human body temperature for people of all ages. It allows you quickly and easily to measure temperature, and values are saved automatically.
2-2. Intended User:
The Non-contacted Infrared Forehead Thermometer is intended for use by qualified medical professional and lay persons.
2-3. Intended patients: People of all ages.
2-4. Intended Environment:
This product is intended for use in a medical facility, such as Hospital, clinic and doctors office, and in a room of general household.
2-5. Precautions for use:
Warnings and cautions described in the instruction manual should be observed.

Product description:

3-1. Visual appearance and structure

3-2. Accessory:
AAA Size (LR03) alkaline battery: 2PCS

Product features:

• Ideal design for easy use;
• Ultra jumbo display, with backlight, easy to read;
• Non-contact, clean, safety and accurate;
• Automatic shut off;
• Beeper alarm;
• Fast measurement within 1 second;
• 32 sets memories recall ;
• °C & °F switchable;
• Two modes: human body and object surface ;
• Wide range of measurement;
• Low voltage indication;
• With AAA size (LR03) alkaline battery (2pcs);
• Optional storage case and carrying bag for easy storage.

Device specifications

34.0℃-42.9℃ (93.2℉-109.4℉)
8| Accuracy| ℃：34.0≤T<35.5℃ & 42.0≤T<43.0℃，±0.3℃ 35.5≤T<42.0℃，±0.2℃ 0≤T<34.0℃ & 43.0≤T<70.1℃，±0.5℃ 70.1≤T≤100.0℃，±1℃
℉：93.2℉≤T<95.9℉& 107.6≤T<109.4℉，±0.6℉ 95.9℉≤T<107.6℉,±0.4℉ 32.0℉≤T<93.2℉& 109.4℉≤T<158.2℉，±0.8℉ 158.2≤T≤199.0℉，±1.6℉
9| Resolution| 0.1℃ / 0.1℉
10| Measure position| Human forehead or, the surface of object
11| Measure speed| about 2 s
12| Measure distance| ≤3 cm (the distance between the sensor and being measure person forehead or surface of object.)
13| High and low temperature warning| Direct Mode:
<0℃: display “Lo”;

100℃: display “Hi “ Adjust mode:
<34.0℃: display “Lo”;
≥43.0℃: display “Hi”;
The   symbol” Lo” represents low temperature; “Hi” represents high temperature.
14| Fever temperature (adjust mode)| ≥37.5℃(99.5℉)
15| Sound notice| Open the device: One “Bi” emits;
Already for the test: One “Bi” emits;
Direct Mode(object temperature mode): One “Bi” emits when finish the test Adjusted Mode(forehead temperature mode): One “Bi” emits when body temperature ＜37.5℃; Six “Bi” emits when body temperature≥37.5℃
16| Automatic shut off| Stop operating the device, it wills automatic shut off after 20 ± 5 seconds.
17| Low power display| The device will display when the battery power is in the range 2.6V± 0.2V.
18| Memory function| 32 sets
19| Working voltage| 3V (2pcs AAA size (LR03) alkaline battery)
20| Work current| ＜60mA
21| standby current| ＜15uA
22| Battery life| At least 1500 measurement
23| Dimension (L x W x H)| 135 x 43 x 42mm
24| Operating Temperature & Humidity Range| 10˚C to 40˚C (50˚F to 104˚F); 30% to 85% RH
Atmospheric pressure:700 hpa~1060 hpa
Note: if the operation temperature is not in the range from 10˚C to 40˚C (50˚F to 104˚F), the device will display “Err”.

25

| Storage Temperature & Humidity Range| -10˚C to 60˚C (14˚F to 140˚F) 25% to 90 % RH Atmospheric pressure:700 hpa~1060 hpa
26| lifetime| 2years(300h)
27| Applied parts| Unit body enclosure
28| PTC resistance specification| 60V, 0.5A
29| Reference body site| Sublingual space in the mouth

Operating Instructions:

6-1. Function instructions:
Please read the following information carefully before measure the temperature.
6-1-1. Switch ON/OFF the unit
A. Power on and self-check function

• Press the button to switch on the thermometer, it will go directly into self-check mode in 1 second and then the LED display , then shows the last memory temperature and after this, “— ℃” or “— ℉” will be showed, at the same time, a
  “Bi” sounds from the buzzer.

• At this time, the measurement can start. Press the button to start the measurement.

B. Switch off:

• After startup, press button and then the unit turn off in the Direct Mode.
• After startup the unit will be shutdown automatically after 20 seconds if no any operation.

6-1-2.℃/ ℉switchable:

• Firstly, Press the button for about 2 seconds while the device is in OFF state.
• Secondly, the device will come into the switchable state, and display the original setting unit (℃ or ℉) for 0.5s.
• Then, the automatic switch the other unit as not same as the original setting unit.
• In the end, waiting for 5 seconds or press the button, the switchable unit (℃ or ℉) operation is done.

6-1-3. Direct mode / adjust mode switchable:
the direct mode
——Press the button to switch on the thermometer, it will go directly into self-check mode in 1 second and then the LED display  , then shows the last memory temperature and after this, “— ℃”or “— ℉” will be showed directly.
——Then press the button, and the LED screen display“— ℃”or “— ℉”, it is the direct mode .

• Adjust mode
  ——Press the button to switch on the thermometer, it will go directly into self-check mode in 1 second and then the LED display , then shows the last memory temperature and after this, “— ℃”or “— ℉” will be showed directly. It is the adjust mode.
  Note:

• The direct mode and adjust mode cannot switch each other, only just choice from adjust mode to direct mode.

• And if you need switch the mode from the direct mode to adjust mode, press the button and the device switch off. Then operated once again according the chapter “adjust mode”

6-1-4. Memories recall:

• When the device is startup and displays on the screen, the device defaults to display the final measurement result.
• At this time, press button to enter the memories mode, click button in order for 1~32 set temperature memories.
• After the 32th set temperature memory, press the button will loop back in the first set temperature memory.
• During in the ”memory recall” mode, if more than 10 seconds no operation, the device will automatically exit the ”memory recall” mode and automatically shut off directly.
• When the memory of temperature displays on the screen, at the same time, the screen will display “ (adjust mode)” or “ (direct mode)” corresponding to indicate that the current memory temperature is the human body temperature (adjust mode) or the object’s surface temperature (direct mode).
• During in the “memory recall” mode, press the button for 3 seconds, it will delete all memory records.

When the battery power voltage is in the range 2.6V(±0.2V), the symbol will be light and display in the LED screen. It means that the user needs to replace new battery.
Note: Handle of the new battery need by the adult or the children under adult supervision.

6-2. Measure temperature.

• When the device is in the measure temperature mode, place the sensor head right in front of the measurement position (patient forehead or object) and the distance is not exceed 3cm.
• Secondly, press the button to measure the temperature. After 1 second, the buzzer makes a “Bi” sound, and the result will display in the LED screen.
• If you need to measure the person temperature, please choice the adjust mode, and the LED screen will display the symbol . (Please see the chapter” 6-1-3. Direct mode / adjust mode switchable)
• If you need to measure the object temperature, please choice the direct mode, and the LED screen will display the symbol . (Please see the chapter” 6-1-3. Direct mode / adjust mode switchable)

6-3. Replacement parts:
There is no part that needs to be replaced by the user except for the AAA size (LR03) alkaline battery.
Note: If the device has a long time not to be used, please remove batteries from the device.
Batteries replacement process:
Step1. Push down the battery cover;
Step2. Take batteries out from the battery slot;
Step3. Insert the new batteries into the battery slot correctly;
Step4. Insert and pull up the battery cover.

Cleaning & Disinfecting

Please keep the device is clean after every use.

• Please use a clean soft cloth or cotton bud that can be moistened with 70% alcohol to clean the sensor.
• The measuring sensor is the most sensitive part of the thermometer, take great care of the measuring sensor when cleaning the device.
• Please use a soft cloth slightly moistened with a mild soapy solution to clean the entire device. Under no circumstances may liquid enter the device. Do not use the device again until it is completely dry.
• Never use abrasive cleaning agents, thinners or benzene for cleaning.
• Do not scratch the surface of the lens and the LED.
• Do not put the device into the water cleaning, in order to avoid damage to the device, use cotton swabs dipped in alcohol or using alcohol content of 70% cotton cloth or cotton to cleaning the enclosure and probe. Please note that don’t let the liquid infiltration inside the thermometer, or use any corrosive cleaner, do not soak with water or other solvents or gasoline detergent.

Storage/Maintenance/Repair

8-1. Storage
To keep your device in the best condition and protect the device from damage follow these
directions:

• Do not leave the device unattended with infants or persons who cannot express their consent.
• Do not subject the device or the parts to any strong shocks such as dropping the device on the floor.
• Do not use or store the device in extreme hot or cold temperatures, high humidity or under direct sunlight or dust.
• Dispose of the device and any used accessories or optional parts according to applicable local regulations.

8-2. Maintenance

• The manufacturer accepts no liability for unauthorized and incorrect reprocessing of this device by external companies!

• The replacement of the battery must only be performed by adult.

• The replacement of the parts must only be performed by the manufacturer or by the distributor.
  – This device is used only for the purposes described in the instruction. The manufacture shall not be liable for damage caused by incorrect use.
  Note:

• Those parts of the device that shall not be serviced or maintained while in use with a PATIENT.

• The patient or the user can replace of batteries, and the children use or replace the battery need under the adult supervision.

8-3.Repair

• Never open or attempt to repair the device by yourself, as otherwise proper function is no longer guaranteed. Failure to observe this regulation shall void the warranty.
• The MANUFACTURER will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information that will assist SERVICE PERSONNEL to repair those parts of ME EQUIPMENT
• If you need to repair the device, contact your equipment provider or that are designated by the MANUFACTURER as repairable by SERVICE PERSONNEL.

TROUBLESHOOTING

assemble the batteries or the internal battery may run out of power and need to assemble or replace with new batteries.
The device measure result is not accurate.| • The measure sensor is dirty, and need to use a clean soft cloth or cotton bud that can be moistened with 70% alcohol.
• The patient uses the device immediately after exercising or walking a long time. And need to rest for 5 mins to 10mins to measure the temperature.
The device displays the symbol”Err”.| The operation environment temperature changes suddenly, and the temperature difference is greater than 8℃, the device will display ”Err”. And it just needs to put the device in the operation environment for 20mins and more, after that to use the device.

Safety precaution:

—— Indicates a potentially hazardous situation which, if not avoided, could result in serious injury.
Read all instructions carefully before use.
Warning:

• No modification of this equipment is allowed.
• Check the thermometer for signs of damage or wear before each use. Damaged or worn thermometer should not be used.
• Under any circumstances, the temperature taking result is ONLY for reference. Before taking any medical action, please consult your physician.
• MR UNSAFE: The device cannot be used in an MR environment.
• The user should report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

10-1. Product cautions:

• If the sensor is degraded or loosened, and the measure value is incorrectly, please stop using the device immediately and contact your equipment provider.

• To avoid electrical shock: Keep the unit away from water. Do not immerse the unit in liquid.
  Do not use while bathing. Do not reach for a unit that has fallen into water.

• Never operate the unit if it has any damaged parts, if it has been dropped or submersed in water. Promptly send it to a service center for examination and repair.

• If any abnormality occurs, discontinue use until the unit has been examined and repaired.

• Do not use other attachments unless recommended by manufacturer.

• This device is not a mirrored one.

• Children are not allowed to use the device unwatched, supervision is needed.

• This device is not waterproof and should not be immersed in water or other liquids. If cleaning is required, please follow the instructions in the “clean and disinfect” section. If you think this device is damaged or abnormal, please stop using this device  and do not open it without permission.

• Failure to read and observe all precautions could result in personal injury or equipment damage.

• Do not use the device to treat the animals, and keep the device away from the pets to avoid damaging the device.

• If the device does not function correctly, stop using the device immediately.

• Switch the device off immediately if it is defective or malfunctioning.

• Keep the device out of the reach of unsupervised infants and children. The device may contain small pieces that can be swallowed.

• Keep children away from packaging materials risk of suffocation.

• Store the parts in a clean location for avoiding infection.

• Do not use the device after exercising, and need to rest for 5 mins to 10mins to measure the temperature.

• Make sure that the sensor is clean before use.

• The unit housing temperature is not exceeding 43℃.

• Protect the device from strong impacts.

• ——Do not use the device if it has fallen or been dropped on the floor, been exposed to extreme humidity or is otherwise damaged in case of doubt, contact our customer service department or your local dealer

10-2. Operating Cautions:

• Close adult supervision is highly recommended when this unit is used by children or invalids.
• Never operate if this unit has a damaged part, and if it has been dropped into water.
• The operation environment temperature changes suddenly, and the temperature difference is greater than 8℃, the device will display ”Err”. Please put the device in the operation environment for 20mins and more, after that to use the device.
• Incorrectly selected the measuring temperature mode incorrectly should result in wrong data. Please operated the device according the chapter 6” operating instructions”.

10-3. Storage Cautions:

• Do not store the unit under direct sunlight, high temperature or humidity.
• Keep the unit out of reach of small children.
• When you are not using the thermometer, please retain it in the storage box.
• Keep the unit stay away from fire and water. Do not test the high temperature or fire so as not to damage the body of the unit.

10-4. Cleaning Cautions:

• Use the cotton buds to clean the probe inside when it has dirt.
• Do not use water or fingers to contact with the probe directly.
• Do not immerse the unit in water. It may damage the unit.

11. SYMBOL GLOSSARY

| Refer to instruction manual/booklet| | Manufacturer
---|---|---|---
| Batch code| | Date of manufacture
| Serial number| | Caution
| Type BF applied part| | Temperature limitation
| Keep away from sunlight| | Protection class II
| Humidity limitation| | Ingress protection
| Direct current| | Keep away from rain
| ON/”OFF” (push-push)| | Alternating current
| This device complies with the requirements of Regulation (EU) 745/2017| | Quantity
| This way up| | Authorized representative
| Fragile; handle with care| | Atmospheric pressure limitation
****| In according with Europeandirective 2002/96/EC on
waste electrical and electronic equipment, this symbol indicates that the product must not be disposed of unsorted municipal waste, but shouldbe collected separately| | Medical Device
| Use by date| |

WARRANTY & DISPOLSAL

Warranty
Vega Non-contacted Infrared forehead thermometer’s warranty period is 2 years from date of purchase from VEGA Technologies Inc. The warranty is limited to repair or replacement, at VEGA Technologies Inc. sole option, of any such component or equipment claimed to be defective when claim is shown to be bona fide by evaluation by VEGA Technologies Inc. This warranty does not extend to any components or equipment subjected to misuse, improper operation, accidental damage, or unauthorized repairs, and is not extended to charges of, or for, labor repairs. All items returned must be properly packaged and shipped, prepaid, by the distributor servicing the unit. VEGA Technologies Inc. shall not be liable to purchaser or others for loss of use of equipment or for indirect, or incidental or consequential damages that might arise.
Disposal
Danger of infection!
The device and accessories may come into contact with infectious material and be contaminated during their lifetime. For this reason the device and its accessories should be decontaminated before disposal or transportation.
**** Dispose of the device properly at the end of its service life. According to the European Directives 2002/96/EC (WEEE) and 2002/95/EC (RoHS) the device may not be disposed of with unsorted domestic waste. Look for a careful separation of materials. Consider the country-specific laws and regulations that apply to the disposal of the device. The proper disposal of the device prevents environmental and human damage.
Outside the EU the appropriate national regulations for disposal must be observed.

Information about Electromagnetic Compatibility

Medical Electrical Equipment needs special precautions regarding Electromagnetic Compatibility (EMC). The device needs to be installed and put into service according to the EMC information provided in this chapter.
Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment. You can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment (transmitters) and the device as recommended below.
Warning:
The device should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used. skin condition may affect measurement accuracy

Table 1

Guidance and manufacturer’s declaration –electromagnetic emissions

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
Emissions test| Compliance| Electromagnetic environment – guidance
RF emissions CISPR 11| Group 1| The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11| Class B| The device is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2| Not applicable
Voltage fluctuations / flicker emissions
IEC 61000-3-3| Not applicable

Table 2

Guidance and manufacturer’s declaration – electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
Electrostatic discharge (ESD)
IEC 61000-4-2| | ± 6 kV contact
± 8 kV air| 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 power supply lines
±1 kV for input/output lines| Not applicable| Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5| ± 1 kV line(s) to line(s)
± 2 kV line(s) to earth| Not applicable| Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11| <5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT) for 5 cycles
70 % UT
(30 % dip in UT) for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s| Not applicable| Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from a continuous power supply or a battery.
Power frequency (50/60 Hz)
magnetic field IEC 61000-4-8| 3 A/m| 3 A/m| 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.

Table 3

Guidance and manufacturer’s declaration – electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
Conducted
RF
IEC
61000-4-6
Radiated RF
IEC
61000-4-3| 3Vrms 150kHz to 80MHz
3V/m 80MHz to 2.5GHz| Not applicable 3V/m| Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2
d = 1.2 80MHz to 800MHz
d = 2.3 800MHz to 2.5GHz
where 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 level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80MHz 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 broadcast and TV broadcast 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 device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.
b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.

Table 4

Recommended separation distances between portable and mobile RF communications equipment and the device

The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter W| Separation distance according to frequency of transmitter m
150kHz to 80MHz d = 1.2 | 80MHz to 800MHz d = 1.2 | 800MHz to 2.5GHz d =2.3
0.01| 0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 12| 12| 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is 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.

Table 5
reference body site: axilla ; measuring site: forehead

Table 6
Accessory battery description

Accessory name| Model| Specifications| Supplier| Photograph
---|---|---|---|---
battery| AAA size (LR03)| 1.5V| Excell|
battery| AAA size (LR03)| 1.5V| Maxell|

Contact information

Vega Technologies Inc.
No.505, Shengping Mid.Road, Yangwu, Dalang Town, 523789 Dongguan City,
Guangdong Province, PEOPLE’S REPUBLIC OF CHINA
Website: www.vegamedical.com
MedPath GmbH
Mies-van-der-Rohe-Strasse 8,80807 Munich, Germany
0123

File No.: IR-IM-001

References

• 东莞东冠电子制品有限公司

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