Femometer DET-1015 Infrared Ear Thermometer User Manual

Femometer DET-1015 Infrared Ear Thermometer

Introduction and Intended Use

The DET-1015 thermometer is specifically designed for safe use in the eardrum. The Infrared Ear Thermometer is a device capable of measuring people’s body temperature by detecting the intensity of infrared light emitted from the ear canal of human. It converts the measured heat into a temperature reading displayed on the LCD. When properly used, it will quickly assess your temperature in an accurate manner.
This appliance conforms to the following standards: EN 12470-5 Clinical thermometers —Part 5: Performance of infrared ear thermometers(with maximum device), 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, 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 and complies with the requirements of IEC 60601-1-2(EMC) , IEC 60601-1(Safety) standards. And the manufacturer is ISO 13485 certified.

Intended Use
The infrared thermometer is intended for the intermittent measurement of human body temperature by people of all ages.

Package contents

1 Infrared ear Thermometer
1 Operating Manual
2 Battery (AA)
24 disposable hygienic lens filters

Package contents

1. This thermometer is intended for home use only. It’s not meant to replace a visit to the doctor. Please consult with a doctor if you have health concerns.
2. There is no gender or age limitation for using infrared ear thermometer.
3. To avoid inaccurate readings, always attach a new, clean probe cover for each temperature reading.
4. Do not expose the thermometer to temperature extremes (below -25°C/-13°F or over 55°C/131°F) nor excessive humidity (>95%RH).
5. This thermometer must only be used with this brand of thermometer probe covers.
6. Keep the battery away from children.
7. Remove battery from the device when not in operation for a long time.
8. Do not put the thermometer in direct sunlight or with cotton wool, otherwise the accuracy will be affected.
9. Portable and mobile RF communications can affect the device. The device needs special precaution regarding EMC according to the EMC information provided in the accompany documents.
10. ME equipment should not be cleaned while in use.

Product Information

Product Description

1. Probe Cover
2. Probe
3. Test Button
4. “ “Button
5. Battery Cover
6. Setting Button

Display description

Temperature taking tips

1. The right ear reading may differ from the reading taken in the left ear.
   Therefore, always take the temperature in the same ear.

2. The ear must be free from obstructions or excess earwax buildup to take accurate reading.

3. External factors may influence ear temperatures such as:
   – lying on one ear or the other
   – their ears covered
   – exposed to very hot or very cold temperatures
   – recently swimming or bathing In these cases, remove the individual from the situation and wait 20 minutes prior to taking a temperature.

4. For people wearing hearing aids or ear plugs, remove the device and wait 20 minutes prior to taking a temperature.

5. When using the thermometer on infants under age 1, pull the ear up making sure the sensor faces the eardrum. (See Figure 5)

6. When using the thermometer on individuals over the age of 1, pull the ear back making sure the sensor faces the eardrum. (See Figure 6)

7. Do not touch the probe window. A cotton swab and rubbing alcohol may be used to clean the sensor window.

8. If the thermometer is stored in a significantly different environment than testing location, place it in the testing location for approximately 30 minutes prior to use.

9. It is not intended for use in the oxygen rich environment and presence of flammable anesthetic mixture with air, oxygen or nitrous oxide.

10. The Applied part is the probe. 11.The patient is an intended operator.
    
    Figure 5
    
    Figure 6

Infrared Ear Thermometer measures core body temperature, which is the temperature of a body’s vital organs. (See Figure 1) Ear temperatures accurately reflect core body temperatures since the eardrum is in the cranial cavity and is not affected by the environment. The eardrum shares blood supply with the hypothalamus (part of the brain.) Therefore, body temperature changes are reflected sooner in the ear than they are in other parts of the body.

Ear Thermometer Advantages

Clinical studies have shown that the ear is an excellent site for temperature measurement because temperatures taken in the ear reflect the body’s core temperature. Body temperature is regulated by the hypothalamus, which shares the same blood supply as the tympanic membrane. Changes in core body temperature are usually seen sooner at the tympanic membrane than at other sites, such as the rectum, mouth or under the arm.
Advantages of taking temperatures at the ear versus other sites:

• Axillary temperature readings only reflect skin temperature which may not indicate the internal body temperature.
• Rectal temperatures often lag significantly behind internal body temperature changes, especially at times of rapidly changing temperatures.
• Oral temperatures are often influenced by eating, drinking, thermometer placement, breathing through the mouth, or the inability of the person to close their mouth completely.

Body Temperature

The temperature of a healthy person is affected by various factors: the person’s individual metabolism, their age(body temperature is higher in babies and toddlers and decreases with age. Greater temperature fluctuations occur faster and more often in children. e.g. due to growth spurts), their clothing, the ambient temperature the time of day(body temperature is lower in the morning and increases throughout the day towards evening), the preceding physical and, to a lesser extent, mental activity.
It is suggested that users develop the habit of daily measurement. and use this product to establish a private normal temperature range for themselves and their families as a reference for measurement.

How to use your thermometer

Real Time Clock Setting
When using thermometer for the first time, please set the parameters of the thermometer.
With the thermometer off, press and hold Setting BUTTON to enter into setting mode.

Set the unit
Press ” ” Button to select the unit you want. After the unit is set, press Setting Button ,the time format figure will appear.

Set the time format
The device can display the time in either an AM/PM (12-hour) or a 24:00 (24-hour) format. Press and release “ ” button to select the format. With the preferred time format on the display, press Setting Button, the Hour figure is flashing automatically.

Set the hour
Press and release the “ ” Button to advance one hour until the correct hour appears. After the hour is set, press Setting Button, the Minute figure is flashing automatically.

Set the minute
Press and release the ” ” Button to advance one minute until the correct minute appears. After the minute is set, press Setting Button, the Year figure is flashing automatically.

Set the year
Press and release the ” ” Button to advance one year until the correct year appears.
After the year is set, press Setting Button, the Month figure will appear.

Set the month
Press and release the ” ” Button to advance one month until the correct month appears. After the month is set, press Setting Button, the Date figure is flashing automatically.

Set the date
Press and release the ” ” Button to advance one day until the correct month appears. After the day is set, press Setting Button to exit the setting mode.

Illustration For Use

To measure ear temperature:

1. DET-1015 must be used with the probe protection cover. If the probe protection cover is not installed, the display will display CAP (as shown in Figure). To reduce the risk of cross-contamination, it is recommended to use a new and clean probe cover for each measurement.

2. When the probe protective cover symbol only displays the symbol, it means that you are preparing to use the probe protective cover for measurement (as shown in Figure 2). When the display symbol is flashing from left to right, it means that you are not using the probe protective cover for measurement (such as Figure 3).
   
   

3. Insert the probe along the ear canal as deep as possible into the ear as depicted in Figure 3. Then press the Test BUTTON once to start the measurement. A long beep will sound approximately 1 second after the Test BUTTON is activated. This signals the end of the process as results are displayed on the LCD screen.

4. The thermometer is ready for testing again once an ear mark displays on the LCD. A waiting period of 20 seconds between testing is recommended to avoid excessive cooling of the skin.

5. The thermometer will shut off automatically after 60 seconds of inactivity. To prolong battery life, press“ ”Button to turn the unit off.
   

After measurement:

1. Power off:
   – Device will automatically shut off if left idle for more than 1 minute to extend battery life.
   – Press ” ” Button to turn it off .

2. Clean the probe after each use to ensure an accurate reading and avoid cross contamination.
   (See the section of Care and Cleaning for details.)

Back Light:

In Ear mode:

• The display will be lighted GREEN for 3 seconds with a happy face ” ” when the unit is ready for measurement and a measurement is completed with a reading less than 37.3°C(99.1°F).
• The display will be lighted YELLOW for 3 seconds with a happy face ” ” when a measurement is completed with a reading less than 37.8°C(100.0°F).
• The display will be lighted RED for 3 seconds with a bad face ” ” when a measurement is completed with a reading equal to or higher than 37.8°C(100.0°F).

Memory Mode

1. The Memory Mode can be accessed in ear mode:
   When the thermometer has been turned on and followed by Figure 2 or finished testing, press and hold the ” ” Button for three seconds. The letter MEM will appear at the bottom of the display. ( See Figure 5)
   2. The thermometer will automatically memorize the last 30 temperature readings. Each memory also records the measurement date/time/ mode icon. Each time the ” ” Button is pressed, the screen displays past readings that correspond with a number 1-30. The number 1 reflects the most recent reading, while the number 30 reveals the oldest reading stored in memory. (See Figure 6)

2. In the memory mode, ” ” mark will not change. The user can press the Test Button to take new measurements.

Situation and Symbols

Troubleshooting

the ( ) icon will appear on the screen and you can take a measurement.
| Measurement before thermometer is ready| Take a measurement until or appears on the display.
| The ambient temperature is not within the range between 10°C and 40°C (50°F~104°F).| Place the thermometer in a room for at least 30 minutes at room temperature between 10°C and 40°C (50°F~104°F).
| The thermometer is placed incorrectly or unsteady.| Read Illustration For Use thoroughly and take a new temperature measurement.
| The thermometer showing a rapid ambient temperature change.| Allow the thermometer to rest in a room for at least 30 minutes at room temperature: between 10°C and 40°C (50°F~104°F).
| The thermometer is not functioning properly.| Unload the battery, wait for 1 minute and repower it. If the message reappears, contact the retailer for service.
| In Ear mode: Temperature taken is higher than 43.0°C(109.4°F).| Read Temperature Taking Hints Thoroughly, then check the integrity of the probe cover and take a new temperature measurement.
| In Ear mode: Temperature taken is lower than 32.0 °C (89.6°F).| Read Temperature Taking Hints thoroughly , then make sure the probe cover and lens filter are clean, then take a new temperature measurement.
| The thermometer works properly.| Use the thermometer normally
| It indicates that the power is low, but you can continue to measure.| The thermometer will take a proper measurement but batteries must be replaced soon.
| The thermometer could not work due to low battery.| Replace two new alkaline batteries size AA . 24

Symbols

| Manufacturer
---|---
| General symbol for recovery/ recyclable
| Date of manufacture
| Batch Code
| Direct Current
| Storage and Transportation Temperature Limit: -25°C~55°C(-13°F~131°F)
| TYPE BF APPLIED PART
| Refer to instruction manual/ booklet
| Atmospheric pressure limitation
| Storage and Transportation Humidity limitation:
15%~95%RH
| Disposal of this product and used batteries should be carried out in accordance with the national regulations for the disposal of electronic products.
| The first num.2: Protected against solid foreign objects of 12,5 mm and greater. The second num.2:Protection against vertically falling water drops when ENCLOSURE tilted up to 15°

Care and cleaning

1. Probe covers are intended for single use only Absent, damaged, perforated, or soiled probe covers can lead to inaccurate temperature readings.

2. The probe window must be kept clean, dry, and undamaged at all times to ensure accurate readings. The accuracy of temperature readings can be affected by damage to the probe window, or the presence of dirt and ear wax on the probe window.

3. Fingerprints, earwax, dust and other soiling compounds reduce transparency of the window and result in lower temperature readings. If the thermometer is accidentally placed in the ear without a probe cover installed, the window must be cleaned immediately.

4. The probe window is the most delicate part of the thermometer. To safely clean the window, gently wipe its surface with a cotton swab slightly moistened with isopropyl alcohol and immediately wipe dry with a clean cotton swab. After cleaning, allow at least 5 minutes drying time before taking temperatures.
   Note: Do not use any chemical other than isopropyl alcohol to clean the probe window.

5. Use a soft, dry cloth to clean the thermometer display and exterior.

6. Do not put the thermometer into water directly.

7. Store the thermometer and probe cover in a dry location, free from dust and contamination and away from direct sunlight.

8. Periodic cleaning of the device following use to prevent patient cross infection.
   -Use a soft cloth slightly moistened with a 75% isopropyl alcohol solution to wipe the thermometer and probe. Do not use abrasive cleaners.

9. Ensure that children do not use the instrument unsupervised; some parts are small enough to be swallowed.

10. Do not remove or modify the equipment without permission.

11. Put the thermometer back to the original packaging after using.

Calibration
The thermometer is initially calibrated at the time of manufacture. If the thermometer is used according to the use instruction, periodic readjustment is not required. However, We recommends checking calibration every two years or whenever clinical accuracy of the thermometer is in question. Please send the complete device to the dealers or manufacturer.
The above recommendations do not supersede the legal requirements.
The user must always comply with legal requirements for the control of the measurement, functionality, and accuracy of the device which are required by the scope of relevant laws, directives or ordinances where the device is used.
A clinical summary and procedures for checking calibration are available upon request.(Turn on the thermometer and press the button long time until entering into calibrate mode, software version will be displayed.)

Battery Replacement

1. Replace battery when ” ” appears in the buttom of LCD display. (See Figure 9)
2. Slide battery cover down as shown in Figure 10.
3. Remove battery and install 2 new AA alkaline batteries as shown in Figure 11 .
4. Slide battery cover back on.

Specifications

display its “oral equivalent.”)
Operation mode| Ear mode(Adjust mode)
Laboratory accuracy| Ear mode: ±0.2°C (0.4°F) during 35.5°C~42.0°C (95.9°F~107.6°F)at 15°C~35°C (59.0°F~95.0°F) operating temperature range±0.3°C (0.5°F) for other measuring and operating temperature range
Display resolution| 0.1°C or 0.1°F
Measure time| Approximately one second
Operating temperature range:| Ear mode: 10°C~40°C(50°F~104°F), 15%~85%RH, non-condensing Atmospheric Pressure : 70kPa~ 106kPa
Storage and transport temperature range| -25°C~ 55°C (-13°F~131°F), 15%~95%RH, non-condensing Atmospheric Pressure : 70kPa~ 106kPa
Clinical accuracy| Clinical bias: 0.08°C( 0.14°F)
Clinical repeatability: 0.13°C( 0.23°F)
Limits of agreement :0.73°C( 1.31°F)
Shock| withstands drop of 3 feet
Dimension| 146.437.657mm
Weight| Approx.117grams(with batteries)
Battery| DC3V(2×AA battery)
Battery life| Approx.6000 readings
Expected service life| Three years
Ingress protecting rating| IP22
Contraindication| No contraindication

EMC information

The device satisfies the EMC requirements of the international standard IEC 60601-1-2.The requirements are satisfied under the conditions described in the table below. The device is an electrical medical product and is subject to special precautionary measures with regard to EMC which must be published in the instructions for use. Portable and mobile HF communications equipment can affect the device. Use of the unit in conjunction with non-approved accessories can affect the device negatively and alter the electromagnetic compatibility. The device should not be used directly adjacent to or between other electrical equipment.

Table 1

Guidance and manufacturers declaration – electromagnetic emission

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 emission CISPR 11| Group 1,| The device uses RF energy only for its internal function. Therefore, its emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emission CISPR 11| Class B| The device is 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| 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| ± 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 100 kHz repetition ± frequency 1 kV for input/ output lines| N/A| N/A
Surge IEC 61000-4-5| ± 0.5 kV，± 1 kV differential mode line-line| N/A| N/A
Voltage dips, short interruptions and voltage variations on power supply in- put lines IEC 61000-4 11|  (100 0%UT UT) % dip in for 0.5 cycle at 0(。), 45(。) 90(。), 135(。),180(。), 225(。), 270(。). and. 315( 。 ) (100 0%UT UT) for% dip in 1 cycle at 0(。) (30 70%UT UT) for % dip in 25/30 cycles at 0( 。 ) (100 0%UT UT) % dip in for 250/300 cycles at 0(。)| N/A| N/A
Power frequency (50/60 Hz) magnetic field IEC 61000 4-8| 30 A/m; 50Hz| 30 A/m; 50Hz| 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 IEC RF 61000- 4-6
Radiated IEC RF 61000- 4-3| 3Vrms 150kHz to 80 MHz 6 Vrms 150 KhZ to 80 MHz outside ISM bandsa 10 V/m 80 MHz to 2.7 GHz| N/A 10V/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

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).
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:

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. The ISM(industrial, scientific and medical) bands between 0,15 MHz 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 MHz. 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,21,0MHz to 21,4MHz,24,89 MHz to 24,99 MHz,28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHZ.
B. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,7 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters in these frequency ranges.
C. 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 re-orienting or relocating the device.
D. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/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 radiation, therefore 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 communication 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| Operation distance according to frequency of transmitter m
150 kHz to 80 MHz
| 80 MHz to 800 MHz | 800 MHz to 2. 7 GHz
0.01| 0.12| 0.04| 0.07
0.1| 0.37| 0.12| 0.25
1| 1.17| 0.35| 0.7
10| 3.7| 1.11| 2.22
100| 11.7| 3.5| 7.0

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.
NOTE1： At 80 MHz and 800 MHz, the separation distance for the frequency range applies.
NOTE2： These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Table 5

Recommended separation distances between RF wireless communications equipment

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 RF wireless communications equipment and the device as recommended below, according to the maximum output power of the communications equipment.
Frequency MNz| Maximum Power W| Distance| IEC 60601 Test Level| Compliance Level| Electromagnetic Environment – Guidance
385| 1.8| 0.3| 27| 27| RF wireless 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 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 transmitter, 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:
450| 2| 0.3| 28| 28
710| 0.2| 0.3| 9| 9
745
780
810| 2| 0.3| 28| 28
870
930
1720| 2| 0.3| 28| 28
1845
1970
2450| 2| 0.3| 28| 28
5240| 0.2| 0.3| 9| 9
5900
5785
Note1: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

WARNINGS!

• This device should not be used in the vicinity or on the top of other electronic equipment such as cell phone, transceiver or radio control products. If you have to do so, the device should be observed to verify normal operation.
• The use of accessories and power cords other than those specified, with the exception of cables sold by the manufacturer of the equipment or system as replacement parts for internal components, may result in increased emissions or decreased immunity of the equipment or system.

Warranty and after-sales service

Warranty
Thermometer is warranted by manufacture to be free from defects in material and workmanship under normal use and service for a period of one year from the date of delivery to the first user who purchases the instrument. This warranty does not cover batteries, damage to the probe window, or damage to the instrument caused by misuse, negligence or accident, and extends only to the first purchaser of the product. Additionally this warranty becomes void, if the thermometer is operated on anything other than this brand thermometer probe covers.

Service

The thermometer has a limited one year warranty. Do not attempt to disassemble or repair the thermometer by yourself. Should service be required during or after the warranty period you must contact the manufacturer. Repackage the thermometer carefully in its original packaging or securely pack to avoid damage during shipping. Include the original sales slip indicating the date of purchase, a note describing the problem, and your return address. Send the thermometer prepaid and insured.

The lay operator or lay responsible organization should contact the manufacturer or the manufacturer’s representative:

• for assistance, if needed, in setting up, using or maintaining the thermometer; or to report unexpected operation or events.

If you suspect any product issues during the warranty period, please contact customer services via：[email protected]

JOYTECH Healthcare Co., Ltd.
No.365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou city, 311100 Zhejiang P.R. China
Document No.: JDET-1504-008
Article No.: 003
Version: B
Date of Issue: 2023.02

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