elepho eThermPro Non-contact Infrared Thermometer User Manual

elepho eThermPro Non-contact Infrared Thermometer

Safety Precautions

•  The use of this thermometer is not intended as a substitute for consultation with your physician. It is dangerous for users to perform a self-evaluation and self-treatment based on the measuring result. Be sure to follow the doctor’s instructions.
•  Keep the thermometer out of the reach of children. If the battery or any other component is swallowed, immediately call a poison center or doctor.
•  Do not dispose of the battery in fire. Must be recycled or disposed of properly.• The device is a precision instrument, don’t drop, tramp or impose any vibration or impact on the thermometer.
•  Do not touch the lens of the probe with your fingers, and do not disassemble the device by yourself.
•  Before measuring temperature, please make sure the area is clear of hair or moisture (i.e. sweat).
•  If you plan on measuring your temperature after exercising, eating, or bathing, please rest in a room temperature area for about 30 minutes prior to measuring the temperature for accurate results.
•  For reliable and stable measurement data, please have the device placed in a room temperature area for at least 30 minutes prior to using.
•  To measure temperature continuously over a duration of time, please make sure to have at least 1-minute intervals between each measurement. Temperature measurements may vary slightly, hence it is recommended that you measure at least three consecutive times and then take the average of the temperatures.
•  There is no absolute standard about the temperature of a person, so please try to collect the recording of Individual temperature in the usual, as a reference for having a fever or not.
•  Do not measure the sites of scarred tissue or tissue compromised by skin disorders, because sensing body temperature from sites of scarred tissue or tissue compromised by skin disorders can lead to not accurate temperature readings.
•  Do not measure in places where there are scars or fresh wounds (especially on the head).
•  Do not measure if a person is treated with certain drug therapies.• Do not measure when the measured sites (forehead) is exposed to direct sunlight, fireplace heat, cold compress therapies, air conditioner flow. If you are under these cases, please leave the status and wait for 30 minutes to measure.
•  Do not immerse the device into water or any other liquid, and do not directly expose it to the sun.
•  Make sure the measuring distance is between 0.4in – 2.5in (1cm – 6cm) when measuring.
•  Do not use a mobile or cordless phone near the thermometer when measuring.
•  Do not measure after using drugs or medication, due to the fact that drugs and medicine can have impacts on the temperature of the body.
•  In order to ensure the accuracy of measurement data, please don’t take measurements of body temperature in strong electromagnetic interference environments (such as microwave, high-frequency equipment operation environments).

Intended use
This non-contact thermometer is intended to measure forehead temperature at home or at the office for all people, from infants to adults.

Temperature Measurement Modes and Range Description
It is used to measure the temperature of the forehead of the human body, and it can also be used to measure the temperature of the surface of objects

Feature

• High reliability
  This product has passed the life and reliability test manufacturers internal, the mean time to failure is≥1000h.

• A wide range of measurement
  Body measurement mode: the measurement range: 89.6˚F – 109.2˚F (32.0˚C – 42.9˚C) Object temperature measurement mode: the measurement range: 32.0˚F – 212.0˚F (0.0˚C – 100.0˚C)

• High accuracy
  This product has passed the industry infrared thermometer performance standards for measuring clinical requirements, measuring clinical repeatability is no more than ±0.5˚F (0.3˚C)
  Smart User Interface and Design
  When the measured body temperature is below 89.6˚F (32.0˚C), the LCD will display the “Lo” prompt. If the measured body temperature is above 109.2˚F (42.9˚C), the LCD will display the “Hi” prompt. When the operating environment exceeds the design specifications, LCD will display the Err prompt. When the thermometer battery power is insufficient, it has a low voltage icon.

• Power saving function
  If there is no operation after the thermometer is turned on or after the temperature measurement, the thermometer automatically enters standby mode in 30s±5S.

• Memory storage function
  The product can store 32 groups of data (temperature and measurement mode) in memory for reference; the memory will override previously stored readings when full.

Overall Description

LCD display description

Operation Instruction

1.  Check battery – Replace the batteries to ensure power supply if there is low voltage icon for the thermometer.

2.  Check thermometer – When you press the “power and scan” button, the system itself test its software and hardware. If there are problems, LCD will display “Err” symbol. Also, please check if the sensor lens is dirty or if there are any damaged parts prior to use.

3.  In order to get accurate measurement results, put the thermometer in the measurement environment for 30 minutes.

4.  Unexpected fluctuations in the ambient room temperature may decrease the accuracy of the measured results.

5.  When measuring forehead temperature, make sure the measured area is clean and cleared or hair in order to ensure the accuracy.

6.  If the ambient temperature exceeds the range of 50˚F – 104˚F (10˚C – 40.0˚C), the thermometer shows Err;

7.  If the measured human temperature value is higher than 109.2˚F (42.9˚C), it shows Hi; If the measured temperature is lower than 89.6˚F (32˚C), Lo is shown.

8.  If 89.6˚F (32˚C) ≤ temperature ≤ 99.5˚F (37.5˚C), green backlight lights up; If 99.7˚F (37.6˚C)≤ temperature ≤109.2˚F (42.9˚C), red backlight lights up; When red backlight lights up are accompanied by the continuous “beeping” Sound, measurement completed, the screen will show the measured temperature value.

9.  When measuring the forehead temperature, you should first remove the hat or arrange the hair on the forehead to prevent the influence of measurement.

10.  Sweat or cosmetics on the forehead will affect the measurement accuracy. Please keep the forehead clean during measurement.

11.  Be careful not to shine LED light into the subject’s eyes during measurement.

12. (3) Measurement mode selection
    Press [Environment/Body temperature switch button] to select the object or human body temperature measurement mode. As below:If there is no action more than 30 seconds after the temperature measurement, the thermometer will automatically come into the standby state with no display on the screen. (6) Memory function The function of data storage: The device can store up to 32 measurements including mode and temperature. When the memory has stored 32 measurements, the following measurements will automatic overwrite the previous measurement.

13. After starting up the thermometer, the thermometer will automatically check for the batteries’ power. If the battery power is too low, the screen will display a low symbol ” “. If the battery has been depleted to be not able to be used normally, the screen will flash the low symbol the automatically turn off after 3 flashes prompting the user to replace the batteries with new ones.
    Battery replacement:

14. Step 1: Open the battery case and take out the old ones.

15. Step 2: Replace the batteries ensuring correct polarity positioning per battery (+/- orientation). replacement.

Please observe the related national and local laws of disposing the old batteries and do not throw directly into the trash. Please take out the batteries if the device is not used for long periods of time. Please don’t put the batteries in fire. We recommend that you choose batteries from well-known brands, to obtain the basic performance and safety guarantees.

Cleaning and Care

The probe tip (lens) is the most fragile and sensitive part of the thermometer. Please keep its entirety clean in order to ensure the accuracy of measurement. The probe tip and lens are the most delicate part of the thermometer. It has to be clean and intact to ensure accurate readings.

•  If the thermometer is ever accidentally dirtied, use the following steps to clean the probe and lens:
•  Very gently wipe the surface with a cotton swab or soft cloth moistened with alcohol. Wait for the alcohol to completely dry out before using.
•  If the lens is damaged, contact the distributor.

Clean the unit body:

•  Use a soft, dry cloth to clean the thermometer display and unit body.
•  If very dirty, use a soft with alcohol to cleaning.

Maintenance

1.  We do not authorize any institution or individual to maintain and repair of the product. If you suspect that the products have any issues, please contact the manufacturer or distributor to handle the case.
2. The user must not attempt any repairs to the device or any of its accessories. Please contact the retailer for repair.
3.  Opening of the equipment by unauthorized agencies is not allowed and will terminate any claim to warranty.

Cleaning Instruction

for 30s.
Isopropyl Alcohol| 70% – 90%| As above.
Glutaraldehyde| 0.5% – 2%e| As above.

Calibration
The thermometer is initially calibrated at the time of manufacture. If this thermometer is used according to the use instruction, periodic re-adjustment is not required. If any time your question the accuracy of measurement, please contact distributor or manufacturer, the contact information see last page.

Accessories

Trouble-Shooting

_ _Troubles or error message| _ _Checklists _ _or situation| _ _Countermeasures or solution
---|---|---

No response/ Automatically reset

| The batteries are used up?| Replace new batteries.
Battery in wrong polarity or type?| Take out the batteries and replace new ones. Take out batteries and reinsert them in the correct orientation
Poor battery contact

The thermometer show the symbol “Hi”

| Temperature hampered by an air flux.| Please leave the area and wait for 30 minutes to measure. Re-measure
In the forehead measurement mode:

–Temperature readings too close together.

–Measured the other object, such as the sunlight, the air from the fireplace.

Hi: Higher than 109.2˚F (42.9˚C);

| ****

according to the manual.

In the object measurement mode:

–Temperature readings too close together.

— The object temperature is higher than 212˚F (100.0˚C).

Hi: Higher than 212˚F (100.0˚C);

The thermometer show the symbol “Lo”

| In the forehead measurement mode:

— The measuring distance is too far.

— Measured the other object, such as the air from the air conditioner.

Lo: Less than 89.6˚F (32.0˚C)

In the object measurement mode:

— The measuring distance is too far.

— Have water vapor condenses on the lens.

Lo: Less than 32˚F (0˚C)

| The ambient temperature is beyond of range of measurement (50˚F-104˚F or 10˚C-40˚C)| Keep the thermometer in the room

Whose Temperature is (50˚F-104˚F or 10˚C-40˚C) for 30 minutes

The sensor or hardware is damaged| Excluding the possibility of temperature allowance first ,then send the device to your dealer for repair
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Low battery, but you can still use it

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Keep an eye on power and continue to use.

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Lower battery, however you can’t use it

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Replace the new battery.

For object surface temperature: 32˚F – 212˚F (0˚C – 100˚C)

Measuring accuracy

| For forehead temperature: 95.0˚F – 107.6˚F ± 0.4˚F (35.0˚C -42.0˚C ± 0.2˚C)

Outside this range: ±0.5˚F (± 0.3˚C)

Clinical repeatability

| Within ±0.5˚F (±0.3˚C) Resolution of display 0.1˚F/0.1˚C

Operation condition temperature

| Temperature: 50.0˚F – 104.0˚F (10.0˚C – 40.0˚C) Relative humidity: ≤ 95%

Atmospheric pressure: 70 kPa – 106 kPa

Transport/Storage condition temperature| Temperature: -13.0˚F – 131.0˚F (-25.0˚C – 55.0˚C) Relative humidity: ≤ 95%

Atmospheric pressure: 70 kPa – 106 kPa

Size| 149x85x44mm
Weight| 110g
Product service life| 5 years
High body temperature hint| ≥100.4˚F (≥38˚C)
Warranty| 1 year
Grade of waterproof| IP22
Electric shock| Internally powered ME equipment
Applied part| Type BF applied part, including the whole unit
Mode of operation| Continuous operation
Software Version| V1.0

Disposal
At the end of the product lifecycle, do not throw this product into the normal household garbage, but bring it to a collection point for the recycling of electronic equipment. Waste Electrical and Electronic Equipment can have potentially harmful effects on the environment. Incorrect disposal can cause harmful toxins to build up in the air, water and soil and can be harmful to human health.

Normalized Symbols

| Complies with the European Medical Device Directive (93/42/ EEC), Notified Body is SGS Belgium NV.
---|---
| Authorized representative in the European Community.
| Attention: see Instructions for use!
| Caution! Consult accompanying documents.
| Type BF applied parts
| Batch code
IP22| IP code of the device: this device’s grade of against ingress of solid foreign objects
| Disposal in accordance with Directive 2002/96/EC (WEEE)
| Keep dry
| UP
|

Fragile, handle with care

****| Stacking layer limit

| Complies with the European Medical Device Directive (93/42/ EEC), Notified Body is SGS Belgium NV.
---|---
| Authorized representative in the European Community.
| Attention: see Instructions for use!
| Caution! Consult accompanying documents.
| Type BF applied parts
| Batch code
IP22| IP code of the device: this device’s grade of against ingress of solid foreign objects
| Disposal in accordance with Directive 2002/96/EC (WEEE)
| Keep dry
| UP
|

Fragile, handle with care

****| Stacking layer limit
_ _Emissions tes t| _ _Compliance| _ _Electromagnetic environment – guidance__

RF emissions CISPR 11

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Group 1

| The eTherm Pro uses RF energy only for its internal function. There for, 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 eTherm Pro suitable for use in all establishments,

including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2| Class A
Voltage fluctuations flicker emissions IEC 61000-3-3| ****

Complies

Guidance and manufacturer´s declaration – electromagnetic immunity

The eTherm Pro is intended for use in the electromagnetic environment specified below. The customer or the user of the eTherm Pro should assure that it is used in such an environment.
Immunity test| IEC 60601| Compliance level| _ _Electromagnetic environment – guidance__
| | | | |
Electrostatic discharge (ESD) IEC 61000-4-2| ± 8 kV contact

± 2 kV, ± 4 kV, ± 8 kV,

± 15 kV air

| ± 8 kV contact

± 2 kV, ± 4 kV, ± 8 kV,

± 15 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 %.
Electrostatic transient / burst IEC 61000-4-4| ± 2 kV for power supply lines

± 1 kV for input/output

lines

| ****

± 2 kV for power supply lines

| Mains power quality should be that of a typical commercial or hospital environment.

Surge

IEC 61000-4-5

| ± 1 kV differential mode

± 2 kV common

mode

| ****

± 1 kV differential mode

| 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

| 0 % UT; 0,5 cycle UT At 0˚, 45˚, 90˚, 135˚, 180˚,

225˚, 270˚ and 315˚ 0 % UT; 1 cycle and

70 % UT; 25/30 cycles Single phase: at 0˚

0 % UT; 250/300 cycle

| 0 % UT; 0,5 cycle UT At 0˚, 45˚, 90˚, 135˚, 180˚,

225˚, 270˚ and 315˚ 0 % UT; 1 cycle and

70 % UT; 25/30 cycles Single phase: at 0˚

0 % UT; 250/300 cycle

| Mains power quality should be that of a typical commercial or hospital environment. If the user of the eTherm Pro requires continued operation during power mains interruptions, it is

recommended that the eTherm Pro be powered from an uninterruptible power

supply or a battery.

Power frequency (50/60 Hz)

magnetic field

IEC 61000-4-8

| ****

30 A/m

| ****

30 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.

Guidance and manufacturer´s declaration – electromagnetic immunit

The eTherm Pro is intended for use in the electromagnetic environment specified below. The customer or the user of the eTherm Pro should assure that it is used in such an environment.
_ _Immunity _ _tes t| _ _IEC 60601 test leve l| _ _Compliance leve l| _ _Electromagnetic environment – guidance__
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3 Vrms

150 kHz to 80 MHz 6 V in ISM and

amateur radio bands between 0,15 MHz

and 80 MHz

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3V

150 kHz to 80 MHz 6 V in ISM and

amateur radio bands between 0,15 MHz

and 80 MHz

| Portable and mobile RF communications equipment should be used no closer to any part of the eTherm Pro , including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

| 10 V/m

80 MHz to 2.7 GHz 385MHz-5785MHz

Test specifications for ENCLOSURE PORT IMMUNITY

to RF wireless communication equipment (Refer to table 9 of IEC 60601-

1-2:2014)

| 10 V/m

80 MHz to 2.7 GHz 385MHz-5785MHz

Test specifications for ENCLOSURE PORT IMMUNITY

to RF wireless communication equipment (Refer to table 9 of IEC 60601-1-

2:2014)

| 80 MHz to 800 MHz

800 MHz to 2.7 GHz

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 metres (m).c

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b

Interference may occur in the vicinity of

equipment marked with the following

| | | symbol:

Proximity magnetic fields

IEC 61000-4-39

| 30 kHz, CW, 8Am

(This test is applicable only to ME EQUIPMENT and ME

SYSTEMS intended for use in the HOME HEALTHCARE ENVIRONMENT)

134,2 kHz, Pulse

modulation 2,1 kHz

65 A/m

13,56 MHz Pulse

modulation 50 kHz

7,5 A/m

| ****

30 kHz, 8A/m

134,2 kHz, 65 A/m

13,56 MHz 7,5 A/m

| ****

The eTherm Pro does not contain magnetically sensitive components.

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic is affected by absorption and reflection from struct-ures, objects and people.

1. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
2. 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 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 Ethereum Pro is used exceeds the applicable RF compliance level above, the eTherm Pro should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re¬orienting or relocating the eTherm Pro.
3. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
   Recommended separation distances between

portable and mobile RF communications equipment and the Ethereum Pro

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

Rated maximum output of the transmitter

W

| Separation distance according to the frequency of transmitter m
150 kHz to 80 MHz outside ISM and amateur radio bands

| 150 kHz to 80 MHz in ISM and amateur radio bands| 80 MHz to 800 MHz| 800 MHz to 2.7 GHz
0.01| N/A| 0.20| 0.035| 0.07
0.1| N/A| 0.63| 0.11| 0.22
1| N/A| 2.00| 0.35| 0.70
10| N/A| 6.23| 1.10| 2.21
100| N/A| 20.00| 35| 70
For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres (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 80 MHz and 800 MHz, 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.

Standard List

EN ISO 15223-1| Medical device – symbols to be used with medical device labels, labeling and information to be supplied – Part 1; General requirements
---|---
EN 1041| Information supplied by the manufacturer with medical devices
IEC 60601-1| Medical electrical equipment Part 1: General requirements for basic safety and essential performance

IEC 60601-1-11

| Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-2| Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
ASTM E 1965| Standard Specification for Infrared Thermometer for Intermittent Determination of Patient Temperature
IEC 62304| Medical device software – Software life-cycle processes
IEC 62366| Medical devices — Application of usability engineering to medical devices IEC 62366:2007
ISO 80601-2-56| Medical electrical equipment – Part 2-56:Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
ISO 10993-1| Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process

Warranty

We provide one year warranty starting from the date of purchase. Please refer to the following situations that are excluded from the free repair services within the warranty period.

1. All damages caused by disassembly and repair of the device by
2. All damages caused by dropping the device during usage, or
3. All damages caused by improper usage of the device and not following the instructions on the userThe warranty period for the device is one year from the date of delivery. In the case of a warranty claim, the date of delivery has to be proven by means of the sales receipt or invoice.

Repairs under warranty do not extend after the warranty period. The following cases are also excluded under the warranty:

• All damage due to improper treatment, g. failure to follow the user guide.
• All damage due to repair or tampering by the customer or unauthorized third
• Damage incurred during transport from the manufacturer to the consumer or during transport to the service center.
• Accessories that are subject to normal wear and
• Battery replacement is not covered under the

Liability for direct or indirect consequential losses caused by the unit is excluded even if the damage to the unit is accepted as a warranty claim.

References

• Elepho | Child and Baby Safety Products that Parents Love ?

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