Product Description 1. Probe Cover 2. Probe 3. Test Button 4. Button 5. Battery Cover 6. Setting Button 3 6 1 2 5 4 3 Electromagnetic Compatibility Information Electromagnetic Compatibility Information Owner's Manual Infrared Ear Thermometer Model DET-1015b Document No.: JDET-1504-005 Article No.: 003 Version: Z Date of Issue: 2020.12 Contents Introduction Introduction
......................................................02 Product Description ........................................... 03 Lcd Display Introduction ......................................... 04 Basic Functions ............................................... 05 Ear Thermometer Advantages ............................ 06 Body Temperature ..............................................08 Real Time Clock Setting ................................. . 09 Illustration For Use ..........................................11 Temperature Taking Hints .................................17 Memory Mode ....................................................19 Care And Cleaning .............................................20 Battery Replacement ..........................................22 Specifications .....................................................23 Troubleshooting
.................................................24 Calibration .............................................................26 Service
.............................................................27 Warranty .............................................................28 FCC Information .....................................................29 Electromagnetic Compatibility Information ...............31 The DET-1015b 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. The infrared thermometer is intended for the intermittent measurement of human body temperature by people of all ages. Please read all instructions carefully and thoroughly before using this product. Warning:
1. This thermometer is intended for home use only. It's not meant to replace a visit to the doctor. Please consult with 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/-13 or over 55/131) nor excessive humidity (>95%RH). 5. This thermometer must only be used with this brand thermometer probe covers. 6. Keep the battery away from children. 7.Remove battery from the device when not in operation for a long time. 1 2 Product Description 1. Probe Cover 2. Probe 3. Test Button 4. Button 5. Battery Cover 6. Setting Button 3 6 1 2 5 4 3 Electromagnetic Compatibility Information Electromagnetic Compatibility Information Product Description LCD Display Introduction 3 6 1 2 5 Bluetooth Sign Object temperature mode Probe cover sign Ear temperature mode Time and date AM and PM sign in Time mode Unit sign: or Temperature indictor Temperature result Voice sign Low voltage sign Memory mode 1. Probe Cover 2. Probe 3. Test Button 4. Button 5. Battery Cover 6. Setting Button 4 3 Basic Functions Ear Thermometer Advantages The real time clock will be recorded with the memor y function and Infrared Ear Thermometer measures core body temperature, Real Time Clock help you to recognize each measurement result. Please see the Real time clock setting section to learn how to setup the time in the first use. which is the temperature of a body's vital organs. (See Figure 1) Ear temperatures accurately reflect core body temperatures since Ear Temperature Mode The thermometer has been designed for practical use. It's not meant to replace a visit to the doctor. Please also remember to compare the measurement result to your regular body temperature. the eardrum is in the cranial cavity and is not affected by the environment. The eardrum shares blood supply with the Please see the Illustration For Use section to learn how to hypothalamus (part of the brain.) Therefore, body temperature measure the body temperature. changes are reflected sooner in the ear than they are in other Probe cover detection and eject function The thermometer has been designed for use with or without probe cover. Users can press the eject button to remove the probe cover. parts of the body. Object Temperature Mode The object mode shows the actual, unadjusted surface temperatures, which is different from the body temperature. It can help you to monitor if the object temperature is suitable for the baby or patient, for example the baby's milk . Please see the Illustration For Use section to learn how to measure the object temperature. If thermometer detects a body temperature 37.8 100.0 )
Beep Alarm under ear mode, there will be a long beep sound followed by three short beep sound to warn the user. Memory Mode There are each 10 sets memories for ear and object measurements. Each memory also records the measurement date/time/mode icon.
Switch V oice Switch Please see the Selecting A Temperature Scale section to learn how to change between Celsius and Fahrenheit. You can use the button to choose whether to turn on or off the sound. Bluetooth sign If the APP is successfully connected to the machine,the Bluetooth sign will always be on, otherwise it will keep flashing. 5 Vital Organs Figure 1 4 6 Product Description Ear Thermometer Advantages Body Temperature 1. Probe Cover 2. Probe 3. Test Button 4. Button 5. Battery Cover 6. Setting Button 4 3 3 6 1 2 5 Electromagnetic Compatibility Information Electromagnetic Compatibility Information 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. 7 9 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. Real Time Clock Setting Real Time Clock Setting When using thermometer for the first time, please set the parameters of the thermometer. 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. 8 10 Product Description 1. Probe Cover 2. Probe 3. Test Button 4. Button 5. Battery Cover 6. Setting Button 3 6 1 2 5 4 3 Electromagnetic Compatibility Information Electromagnetic Compatibility Information Illustration For Use Illustration For Use To measure ear temperature:
3. Insert the probe along the ear canal as deep as possible into the 1. To achieve accurate readings, make sure a new, clean probe cover ear as depicted in Figure 3. Then press the Test BUTTON once is in place before each measurement. Place a new probe cover on to start the measurement. A long beep will sound approximately the probe firmly; making sure the probe and the inner portion of the probe cover fit snugly. 2. Press the Button
, The display is activated to show all segments. After self-checking Figure 2 appears on the display screen with beeps, so you can start a new measurement. If error messages appears, it means the thermometer is not ready for measurement. Remarks:
a. Probe cover sign stand for taking the ear temperature with probe cover now and vice versa. b. To avoid the risk of cross contamination, it is recommended that you always measure the ear temperature with probe cover. 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. X 11 Figure 2 Figure 3 12 Illustration For Use Illustration For Use To measure object temperature:
After measurement:
1. First eject the probe cover. 1. Power off: Device will automatically shut off if left idle for 2. Aim the thermometer at the center of the object you want to more than 1 minute to extend battery life. measure with a distance of 1 to 2 cm. 2. Clean the probe after each use to ensure an accurate reading and 3. Press the Button to turn on the thermometer, you can take avoid cross contamination. the object temperature after hearing two beep sounds.(see figure 4)
(See the section of Care and Cleaning for details.) Remarks:
This mode shows the actual, unadjusted surface temperatures, which is different from the body temperature. BackLight:
In Ear mode:
1. 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 then 37.3
(99.1 ). 2. 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(100.0 ). 3. 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(100.0 ). The display will only be lighted GREEN for 3 seconds when the unit is ready for measurement and a measurement is completed. 14 Figure 4 How to change the ear mode and object mode:
You can press and hold Setting Button to switch the mode between In Object mode:
ear mode and object mode. 7 13 Product Description 1. Probe Cover 2. Probe 3. Test Button 4. Button 5. Battery Cover 6. Setting Button 3 6 1 2 5 4 3 Electromagnetic Compatibility Information Electromagnetic Compatibility Information Illustration For Use Bluetooth requirements The thermometer requires a bluetooth device with:
. Bluetooth 4.0 or later
. Android 6.0 or later
. IOS 8.0 or later And works with:
. iphone , iPod, iPad
. Android Phones and Tablets Using for the first time 1. Download the "JoyHeath" App from Website or APP Store (Such as Apple Store). 2.Open the App on your phone or tablet. If requested, you should Illustration For Use Illustration For Use Match your thermometer with a Smart Device 1. If this is your first time using it, bind first.Open "SETTING"
menu,chooseBind and unbind device" and select the appropriate model. The date and time on your thermometer will automatically be updated when it's connected with your phone. 2. Confirm that your thermometer is connected successfully. When your thermometer is connected successfully to your smart phone, the symbol stop flashing and keep showing. Transfer your readings 1. As soon as your measurement is finished, open the app on enable Bluetooth on your device. You can enable Bluetooth under your smart phone to transfer the reedings. the Settings menu on your smart phone or tablet. Note: On the matched smart phone, Bluetooth must be enabled. 3. Create a new user login, or login with your existing user name and 2. You can view your temperature readings in the app. password. 4. Selection device Thermometer. Temperature Taking Hints Temperature Taking Hints 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. 1. The right ear reading may differ from the reading taken at 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 an 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 persons 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) 15 17 16 18 Figure 5 Figure 6 Product Description 1. Probe Cover 2. Probe 3. Test Button 4. Button 5. Battery Cover 6. Setting Button 3 6 1 2 5 4 3 Electromagnetic Compatibility Information Electromagnetic Compatibility Information Memory Mode Care And Cleaning 1. The Memory Mode can be accessed ether in ear mode or object mode:
When the thermometer has been turned on and followed by Figure 2/4 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. 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) 3. In the memory mode, mark or mark will not change. The user can press the Test Button to take new measurements. Each memory also records the Figure 5 Figure 6 19 7. Store the thermometer and probe cover in a dry location, free from dust and contamination and away from direct sunlight. 8. Periodic cleaning and disinfection of the device following use to prevent patient cross infection.
-Use a soft cloth slightly moistened with a 75% isopropyl alcohol solution to disinfect 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. Strong electromagnetic fields may interfere with the proper operation of the thermometer. The device needs special pre-cautions regarding EMC according to the EMC information. 12. Put the thermometer back to the original packaging after using. 13. It is not intended for use in the oxygen rich environment and presence of flammable anesthetic mixture with air, oxygen or nitrous oxide. 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. 20
1. Replace battery when " appears in the buttom display. (See Figure 10) 2. Slide battery cover down as shown in Figure 11. 3. Remove battery and install 2 new AAA alkaline batteries as shown 4. Slide battery cover back on. in Figure 12
. of LCD Figure10 Figure11 Care And Cleaning Battery Replacement 21 Figure 12 22 Product Description 1. Probe Cover 2. Probe 3. Test Button 4. Button 5. Battery Cover 6. Setting Button 3 6 1 2 5 4 3 Electromagnetic Compatibility Information Electromagnetic Compatibility Information Specifications Troubleshooting Error message Problem Solution Measurement before thermometer is ready Take a measurement until or appears on the display. Measuring range Ear mode: 32.0~43.0(89.6~109.4) Object mode: 0~100(32~212) Measuring site Ear canal(Ear Mode) Reference body site Oral (This thermometer converts the ear temperature to display its oral equivalent.) Operation mode Ear mode(Adjust mode) Laboratory accuracy Ear mode:
0.2 (0.4) during 35.5~42.0 (95.9~107.6) at 15~35 (59.0~95.0) operating temperature range 0.3 (0.5) for other measuring and operating temperature range Object mode: 4% or 2(4) whichever is greater Display resolution 0.1 or 0.1 Measure time Operating temperature range:
Storage and transport temperature range Approximately one second Ear/Object mode:
10~40(50~104), 15%~85%RH, non-condensing Atmospheric Pressure : 7
-25~ 55 (-13~131), 15%~95%RH, non-condensing Atmospheric Pressure : 7 00hPa ~ 1060hPa 00hPa ~ 1060hPa Clinical accuracy Shock Dimension Weight Battery Clinical bias0.08(0.14) Clinical repeatability0.13(0.23) Limits of agreement:0.73(1.31) withstands drop of 3 feet 57*146*38mm Approx.83grams(with batteries) DC3V(2AA battery) Battery life Approx. 1 year/6000 readings Expected service life Three years Ingress protecting rating IP22 23 Error message Problem Solution The ambient temperature is not within the range between 10 and 40
(50~104). The thermometer is placed incorrectly or unsteady. The thermometer showing a rapid ambient temperature change. The thermometer is not functioning properly. thermometer Place the in a room for at least 30 minutes at room temperature between 10 and 40
(50~104) Read Illustration For Use thoroughly and take a new temperature measurement. Allow the thermometer to rest in a room for at least 30 minutes at room temperature:
between 10 and 40
(50~104) Unload the battery, wait for 1 minute and repower it. If the message reappears, contact the retailer for service. 24 Troubleshooting Calibration Remove probe cover in object temperature mode. 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. Read Temperature Taking Hints Thoroughly, then check the integrity of the probe cover and take a new temperature measurement. 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 power button long time until entering into calibrate mode, software version will be displayed.) Read Temperature Taking Hints thoroughly , then make sure the probe cover and lens filter are clean, then take a new temperature measurement. Type B F applied part Direct Current In object temperature mode, measurement with probe cover. In Ear mode:
Temperature taken is higher than 43.0
(109.4). In Object mode:
Temperature taken is higher than 100
(212). In Ear mode:
Temperature taken is lower than 32.0
(89.6). In Object mode:
Temperature taken is lower than 0
(32). The thermometer could not work due to low battery. Replace two new alkaline batteries size AAA. 25 Disposal of this product and used batteries should be carried out in accordance with the national regulations for the disposal of electronic products Consult Accompanying Documents LOT Batch Code 55 Storage and Transportation Temperature Limit:
-13131(-25~55)
-25 26 Product Description 1. Probe Cover 2. Probe 3. Test Button 4. Button 5. Battery Cover 6. Setting Button 3 6 1 2 5 4 3 Electromagnetic Compatibility Information Electromagnetic Compatibility Information Service Warranty 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. 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. Manufacturer:
JOYTECH HEALTHCARE Co., Ltd. No.365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou city, 311100 Zhejiang,China Telephone: +86-571-81957767 Fax: +86-571-81957750 The product is in compliance with the requirements of MDD 93/42/EEC, "0197" is the identification number of notify body;
0197 EC REP European Authorized Representative:
Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany 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 to only to the first purchaser of the product. Additionally this warranty becomes void, if the thermometer is operated with anything other than this brand thermometer probe covers. FCC Information FCC Information This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may cause undesired operation. The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction. Caution: Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user authority to operate the equipment.
*Note:
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try and correct the interference by one or more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the distance between the equipment and the receiver.
- Connect the equipment to an outlet on a circuit different from that to which the receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help. 27 29 28 30 Electromagnetic Compatibility Information Electromagnetic Compatibility Information Product Description Electromagnetic Compatibility Information Electromagnetic Compatibility 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. 1. Probe Cover 2. Probe 3. Test Button 4. Button 5. Battery Cover 6. Setting Button 4 3 3 6 1 2 5 Electromagnetic Compatibility Information Electromagnetic Compatibility Information 31 33 32 34 Electromagnetic Compatibility Information Electromagnetic Compatibility Information Product Description Electromagnetic Compatibility Information Table 3 continued Electromagnetic Compatibility Information 1. Probe Cover 2. Probe 3. Test Button 4. Button 5. Battery Cover 6. Setting Button 4 3 3 6 1 2 5 NOTE 1At 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 MHzto6,795 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. Electromagnetic Compatibility Information Electromagnetic Compatibility Information 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 cord 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. 35 37 36 38