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    K Number
    K230075
    Device Name
    Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K
    Manufacturer
    Microlife Intellectual Property GmbH
    Date Cleared
    2023-06-28

    (169 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Microlife Intellectual Property GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Upper Arm Blood Pressure Monitor, Model BP3K V 1-5K is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm for a circumference range from 17 to 52cm. The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected. The device can be used in connection with a smart phone via Bluetooth or with a personal computer (PC) via USB. The measurement data can be transferred to a smart phone running the Microlife Connected Health+ mobile software (App) or a PC running the Microlife BP Analyzer+ (BPA+) software.
    Device Description
    Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5K is designed to measure systolic and diastolic blood pressure, pulse rate of an individual with arm circumference sizes ranging from 17-52 cm by using a noninvasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but using a semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method". The device detects the appearance of irregular heartbeat during measurement, and the symbol " " is displayed with the reading. The device can be used in connection with smart mobile devices running the APP and via Bluetooth. The blood pressure monitor is a fully automatic digital blood pressure measuring device use by adults on the upper arm at home.
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    K Number
    K222979
    Device Name
    Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W
    Manufacturer
    Microlife Intellectual Property GmbH
    Date Cleared
    2023-05-19

    (233 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Microlife Intellectual Property GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Upper Arm Blood Pressure Monitor, Model BP3KV1-5W is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm for a circumference range from 22 to 52cm. The device is suitable for use by adults with conditions of diabetes, pregnancy, or pre-eclampsia. The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected. The device can be used in connection with a smart phone via Bluetooth or with a personal computer (PC) via USB. The measurement data can be transferred to a smart phone running the Microlife Connected Health+ mobile software (App) or a PC running the Microlife BP Analyzer+ (BPA+) software.
    Device Description
    Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W is designed to measure systolic and diastolic blood pressure, pulse rate of an individual with arm circumference sizes ranging from 22 -52 cm by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but using a semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method". The device detects the appearance of irregular heartbeat during measurement, and the symbol " "\\\ "is displayed after the measurement. In addition, the device can be used in connection with smart mobile devices running the APP and via Bluetooth. The blood pressure monitor is a fully automatic digital blood pressure measuring device use by adults on the upper arm at home.
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    K Number
    K222153
    Device Name
    Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)
    Manufacturer
    Microlife Intellectual Property GmbH
    Date Cleared
    2023-02-03

    (198 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Microlife Intellectual Property GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlife Upper Arm Automatic Digital Blood Pressure and Cardiovascular Screening Monitor Model WatchBP Office Vascular (TWIN200 VSR) is a non-invasive digital blood pressure device using the oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate, mean arterial pressure (MAP) for use in adults and pediatrics (but not neonates) with arm cuff circumference sizes ranging from 14-52 cm (5.5-20.5 inches). The device can accurately measure in pregnant patients including those with known or suspected preeclampsia. The device detects the appearance of atrial fibrillation during measurement and gives a warning signal together with the measured blood pressure value if atrial fibrillation is detected. The device provides aortic blood pressure parameters, including central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic blood pressure (cDBP), non-invasively through the use of a brachial cuff. This was validated against invasive blood pressure measurement and showed that the device determines central blood pressure measurement with high accuracy. The device provides a validated method for determining the ankle-brachial index (ABI) which may be useful in diagnosing Peripheral Artery Disease (PAD). The device is only intended to provide a numerical value of brachial-ankle pulse wave velocity (baPWV) for blood flow inside the intended blood vessel, without any diagnosis. The memory data can be transferred to the PC running the WatchBP Analyzer software by connecting the monitor via USB cable or Bluetooth. The device is intended for use by healthcare professionals in clinical practice.
    Device Description
    Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office Vascular (TWIN200 VSR) is designed to measure svstolic and diastolic blood pressure, pulse rate, and mean arterial pressure (MAP) of the "adults and pediatrics (but not neonates)" populations with arm circumference sizes ranging from 14 -52 cm by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use a resistive pressure sensor rather than a stethoscope and mercury manometer. The sensor convert tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, mean arterial pressure (MAP), central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic pressure (cDBP) which is a well - known technique in the market called the "oscillometric method". The device has two settings of measurement. One setting is for measurement on one arm or on both arms simultaneously. The measurement program of the device can be set when the measurement of one arm or both arm is selected, including Number of Measurements. Resting Time (Countdown Time), Interval Time, AFIB Detector, CBP Measurement, and Average Calculation (Discard 1st measurement or not). The other setting is for measurement on one arm with one leq, this measurement is selected when assessing brachial-ankle Pulse Wave Velocity (baPWV) and Ankle Brachial Index (ABI) measurement. In addition, the device can be used in connection with your personal computer (PC) running the WatchBP Analyzer software. The memory data can be transferred to the PC by connecting the monitor with the PC via USB cable or Bluetooth. The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia. The device detects the appearance of atrial fibrillation during measurement and the atrial fibrillation symbol "is displayed on the LCD screen if any atrial fibrillation signal has been detected. The device provides aortic blood pressure parameters, including central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic blood pressure (cDBP), non-invasively through the use of a brachial cuff. The device provides a validated method for determining the ankle-brachial index (ABI) which may be useful in diagnosing Peripheral Artery Disease (PAD). The device is only intended to provide a numerical value of brachial-ankle pulse wave velocity (baPWV) for blood flow inside the intended blood vessel, without anv diagnosis. The device is for hospital use only.
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    K Number
    K211776
    Device Name
    Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)
    Manufacturer
    Microlife Intellectual Property GmbH
    Date Cleared
    2022-03-01

    (265 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Microlife Intellectual Property GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home. The device can be used in connection with a smart phone running the «Microlife Connected Health +» APP. The memory data can be transferred to the smart phone via Bluetooth.
    Device Description
    The Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) is an electronic thermometer using an infrared sensor, which is composed of thermistor and thermopile, to measures infrared energy radiated from the forehead as well as objects. This energy is collected through the lens and converted to a temperature value. The thermistor measures the ambient temperature of the sensor by changing the resistance. The function of thermopile is to measure the voltage difference between the temperature corresponding to the infrared radiation induction and the temperature difference measured by thermistor. Based on the voltage difference, difference temperature can be calculated, and the target temperature can be obtained by adding thermistor's temperature. The Microlife Non-Contact Infrared forehead thermometer, Model FR1MF1-B (NC150 BT), consists of the following parts: a) Thermopile Sensor b) Microcontroller Unit c) LCD and Backlight d) 4 buttons ("START" button, "ON/OFF" button, "M" button, "MODE" button) e) Alkaline batteries; size AAA, 2 x 1.5 V f) Lens g) Bluetooth module
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    K Number
    K211288
    Device Name
    Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B
    Manufacturer
    Microlife Intellectual Property GmbH
    Date Cleared
    2021-11-04

    (190 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Microlife Intellectual Property GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wrist Watch Blood Pressure Monitor, Model BP3GK1-4B is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist for a circumference range from 13.5 to 21.5cm. The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected. The device can be used in connection with a smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.
    Device Description
    Microlife Wrist Watch Blood Pressure Monitor, Model BP3GK1-4B is designed to measure systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses a semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method". The device detects the appearance of irregular heartbeat during measurement. In addition, the device can be used in connection with smart mobile devices running the APP and via Bluetooth.
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    K Number
    K202729
    Device Name
    Microlife Upper Arm Automatic Digital Blood Pressure Monitor
    Manufacturer
    Microlife Intellectual Property GmbH
    Date Cleared
    2021-04-08

    (202 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Microlife Intellectual Property GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlife Upper Arm Automatic Digital Blood Pressure Monitor,Model WatchBP O3 (BP3SZ1-1) is a non-invasive 24 hour ambulatory blood pressure monitor (ABPM) using oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate, mean arterial pressure (MAP) for or use in adults and pediatrics (but not neonates) with arm cuff circumference sizes ranging from 14 -52 cm. The device can accurately measure in pregnant patients including those with known or suspected preeclampsia. The device provides aortic blood pressure parameters, includes central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic blood pressure (cDBP), non-invasively through the use of a brachial cuff. The device detects the appearance of atrial fibrillation during measurement and gives a warning signal together with the measured blood pressure value if atrial fibrillation is detected. The memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer software by connecting the monitor via USB cable or Bluetooth. The device is intended to be used by healthcare professionals and patient's environments.
    Device Description
    Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP O3 (BP3SZ1-1) is designed to measure systolic and diastolic blood pressure, pulse rate, and mean arterial pressure (MAP) of the adults and pediatrics (but not neonates) populations with arm circumference sizes ranging from 14 -52 cm by using a noninvasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use a resistive pressure sensor rather than a stethoscope and mercury manometer. The sensor convert tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, mean arterial pressure (MAP), central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic pressure (cDBP) which is a well - known technique in the market called the "oscillometric method". The device is a 24 hour ambulatory blood pressure monitor (ABPM) .It's selected for fully programmable 24-hour patient out-of-office blood pressure measurement, the device automatically takes measurements at fixed intervals programmed by the physician. The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia. The device detects the appearance of atrial fibrillation during measurement and the atrial fibrillation symbol "is displayed on the LCD screen if any atrial fibrillation signal has been detected. In addition, the memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer software by connecting the monitor via USB cable or Bluetooth. The device is intended to be used by healthcare professionals and patients in clinical and patient's environments.
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    K Number
    K200738
    Device Name
    Microlife Upper Arm Automatic Digital Blood Pressure Monitor
    Manufacturer
    Microlife Intellectual Property GmbH
    Date Cleared
    2020-07-23

    (122 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Microlife Intellectual Property GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home A BT (BP3MX1-3C) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual with arm cuff circumference sizes ranging from 22 -42 cm by using a non-invasive oscillometric technique in one inflatable cuff being wrapped around the upper arm. The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected. The memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer Home software by connecting the monitor via cable. The device can also be used in connection with smart mobile devices running the APP and via Bluetooth. The device is intended for use by patient at home or by health care givers in primary care settings.
    Device Description
    Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home A BT (BP3MX1-3C) is designed to measure systolic and diastolic blood pressure and pulse rate of an adult individual with arm circumference sizes ranging from 22 -42 cm by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use a resistive pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well known technique in the market called the "oscillometric method". The device has <<USUAL>> and <<DIAG.>> measurement modes. The <<USUAL>> mode is selected for a regular single measurement. The << DIAG.>> mode is selected for diagnosis or follow-up. The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected. If atrial fibrillation is detected during all readings of the triple measurements in usual mode or all four readings of one day in diagnostic mode, the Afib icon is displayed. In addition, the memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer Home software by connecting the monitor via cable. The device can also be used in connection with smart mobile devices running the APP and via Bluetooth. The device is intended for use by patient at home or by health care givers in primary care settings.
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    K Number
    K200297
    Device Name
    Microlife Upper Arm Automatic Digital Blood Pressure Monitor
    Manufacturer
    Microlife Intellectual Property GmbH
    Date Cleared
    2020-06-18

    (133 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Microlife Intellectual Property GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlife Upper Arm Automatic Digital Blood Pressure Monitor,Model WatchBP Office (BP3SK1-3B) is a noninvasive digital blood pressure device using oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate, mean arterial pressure (MAP) for use in adults and pediatrics (but not neonates) with arm cuff circumference sizes ranging from 14 -52 cm. The device can accurately measure in pregnant patients including those with known or suspected preeclampsia. The device provides aortic blood pressure parameters. includes central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic blood pressure (cDBP), non-invasively through the use of a brachial cuff. The device detects the appearance of atrial fibrillation during measurement and gives a warning signal together with the measured blood pressure value if atrial fibrillation is detected. The memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer software by connecting the monitor via USB cable or Bluetooth. The device is for hospital use only.
    Device Description
    Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office (BP3SK1-3B) is designed to measure systolic and diastolic blood pressure, pulse rate, and mean arterial pressure (MAP) of the adults and pediatrics (but not neonates) populations with arm circumference sizes ranging from 14 -52 cm by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use a resistive pressure sensor rather than a stethoscope and mercury manometer. The sensor convert tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, mean arterial pressure (MAP), central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic pressure (cDBP) which is a well - known technique in the market called the "oscillometric method". The device has two measurement modes that can be used :<< AUTO>> mode and << MANUAL>> mode. It has number of measurements setting function, resting time setting function, measurement intervals setting function, atrial fibrillation detection function, Central Blood Pressure (CBP) measurement function etc. In addition, the device can be used in connection with your personal computer (PC) running the WatchBP Analyzer software. The memory data can be transferred to the PC by connecting the monitor with the PC via USB cable or Bluetooth. The measurement program in << AUTO>> mode of the device can be set, includes Number of Measurements, Resting Time (Countdown time), Interval Time, AFIB detector, CBP measurement, HIDE and Average calculation (Discard 1st measurement). Select << AUTO>> mode, press the Ubutton to perform automatic measurements based on the settings of << AUTO>> mode. The device shows all the settings and then starts counting down the Resting Time before the first measurement. The average measurement reading is displayed and saved after the measurements are complete. The measurement program in << MANUAL>> mode can be set to preferences. The program includes setting the Highest Cuff Pressure and Hide Cuff Pressure during deflation. Select the << MANUAL>>mode if auscultatory blood pressure measurement is preferred above oscillometric blood pressure measurement. In << MANUAL>> mode, the device serves as a pressure gauge. No oscillometric measurements will be taken. Systolic and diastolic Korotkoff sounds are determined by the physician using a stethoscope placed over the brachial artery. The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia. The device detects the appearance of atrial fibrillation during measurement and the atrial fibrillation symbol "is displayed on the LCD screen if any atrial fibrillation signal has been detected. The device is for hospital use only.
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    K Number
    K191829
    Device Name
    Microlife Non-Contact Infrared Forehead Thermometer
    Manufacturer
    Microlife Intellectual Property GmbH
    Date Cleared
    2020-02-13

    (219 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Microlife Intellectual Property GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DG1 (NC200) is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.
    Device Description
    The Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DG1 (NC200) is an electronic thermometer using an infrared sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to a temperature value. The device uses CapSense Technology to detect distance this technology is used to assist measurement. The concept of proximity sensor detects human electrical proximity level to transform to distance. The distance control feature is added to the user interface to identify the measurement distances are in the correct parameter. In other words, the device will enter into measurement mode after the correct measurement distance is detected. This device can take a measurement automatically when the device detects the distance is appropriate within 5 cm.
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    K Number
    K183663
    Device Name
    Microlife Digital Infrared Ear Thermometer
    Manufacturer
    Microlife Intellectual Property GmbH
    Date Cleared
    2019-07-16

    (201 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Microlife Intellectual Property GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlife Digital Infrared Ear Thermometer, Model IRIDNI (IR210) device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediation used in the home setting.
    Device Description
    The Microlife Digital Infrared Ear Thermometer, Model IR1DN1 (IR210) is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces.
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