FCC ID: 2AQVELM1CS LiveMetric

INSTRUCTIONS FOR USE INSTRUCTIONS FOR USE LIVEMETRIC LM1CS BLOOD PRESSURE MONITOR 2797 Page 1 of 28 TABLE OF CONTENTS Introduction ..................................................................................................................................... 5 Safety information .......................................................................................................................... 5 Intended Use ............................................................................................................................... 5 Indications for Use ...................................................................................................................... 5 Contraindications ........................................................................................................................ 6 Receiving and Inspection ............................................................................................................ 6 Your Package includes:........................................................................................................... 6 General Warnings ........................................................................................................................... 6 General Precautions ........................................................................................................................ 8 Safety Symbols used in this Product Labeling ........................................................................... 9 Before taking blood Pressure measurements .................................................................................. 9 Know Your Monitor ..................................................................................................................... 10 Wristband .................................................................................................................................. 10 Charging Clip ............................................................................................................................ 10 Charging Cable ......................................................................................................................... 10 Insert Image- ......................................................................................................................... 10 Instruction Manual ........................................................................................................................ 10 Using the Wristband for the First Time ........................................................................... 10 Charging the Battery ............................................................................................................. 11 Download LiveMetric App ................................................................................................... 11 Setup the LiveMetric App ..................................................................................................... 11 Pair Your Wristband with a Smartphone .............................................................................. 12 Placing the Waistband........................................................................................................... 13 Taking your First Measurement ............................................................................................ 13 Page 2 of 28 Using Your Device Daily...................................................................................................... 14 Recommended Method to Blood Pressure Measurements ....................................................... 14 Perform Manual Measurement ..................................................................................................... 15 WARNING! .............................................................................................................................. 15 Scheduling Background Blood Pressure Measurements .............................................................. 15 Recording Events .......................................................................................................................... 16 Viewing Readings and Generate Reports ..................................................................................... 16 Notifications .................................................................................................................................. 17 Settings .......................................................................................................................................... 17 Bluetooth Settings ..................................................................................................................... 17 Entering Bluetooth Pairing Mode ......................................................................................... 17 Disconnecting Your Wristband............................................................................................. 17 Selecting which Wrist the Band is Placed On .......................................................................... 17 Resetting Your Wristband......................................................................................................... 17 Notification/LED Light Settings ............................................................................................... 17 Error Messages and Troubleshooting ........................................................................................... 18 Troubleshooting ........................................................................................................................ 18 Error Messages.......................................................................................................................... 21 Maintenance .................................................................................................................................. 22 Storage .......................................................................................................................................... 23 Cleaning ........................................................................................................................................ 23 Warnings! ...................................................................................................................................... 23 Disposal......................................................................................................................................... 23 Specifications ................................................................................................................................ 23 Performance .............................................................................................................................. 24 Page 3 of 28 Sensors ...................................................................................................................................... 24 Materials ................................................................................................................................... 24 Wireless Technology ................................................................................................................ 24 Battery ....................................................................................................................................... 24 Memory ..................................................................................................................................... 24 Wristband size ........................................................................................................................... 24 Environmental conditions ......................................................................................................... 24 Technical Data .......................................................................................................................... 24 Input voltage range ............................................................................................................... 25 FCC Statement .............................................................................................................................. 25 Trademark Statement .................................................................................................................... 26 Page 4 of 28 PLEASE READ THIS USER LEASE READ THIS USER MANUAL THOROUGHLY BEFORE USING THE WRIST FORE USING THE WRISTBAND. KEEP THE USER MANUAL THE USER MANUAL FOR FUTURE REFERENCE FOR FUTURE REFERENCE. FOR SPECIFIC INFORMATION ABOUT YOUR OWN ABOUT YOUR OWN BLOOD PRESSURE, CONSULT CONSULT YOUR DOCTOR. INTRODUCTION Thank you for purchasing the LiveMetric Thank you for purchasing the LiveMetric LM1CS Blood Pressure Monitor. The Blood Pressure Monitor. The LM1CSis a wristbandthat can be worn comfortably all day long, and is intended to measure your blood wristbandthat can be worn comfortably all day long, and is intended to measure your blood wristbandthat can be worn comfortably all day long, and is intended to measure your blood pressure and provide you with s pressure and provide you with systolic, diastolic and heart rate values. The wristband

. The wristband utilizes highly responsive sensors, in conjunction with advanced Artificial Intelligence technology, to highly responsive sensors, in conjunction with advanced Artificial Intelligence technology, to highly responsive sensors, in conjunction with advanced Artificial Intelligence technology, to provide accurate measurements ofyour ments ofyour blood pressure. The wristband can be operated by simply

. The wristband can be operated by simply pushing a button, there is no need to calibrate the device hing a button, there is no need to calibrate the device. You can view measurements either on

. You can view measurements either on the digital watch face or on the LiveMetric the digital watch face or on the LiveMetric mobile application. SAFETY INFORMATION INTENDED USE measured on the patient's wrist. measured on the patient's wrist. LiveMetric LM1CS is a non-invasive blood pressure monitor. The blood pressure waveform is invasive blood pressure monitor. The blood pressure waveform is invasive blood pressure monitor. The blood pressure waveform is The LiveMetric LM1CS provides a noninvasive characterization of the arterial circulation and its provides a noninvasive characterization of the arterial circulation and its provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow, as beat variability in pressure and flow, as well as various hemodynamic parameters derived well as various hemodynamic parameters derived from these pressure signals. The Interpretation of the numerical values will be made by medical professionals only. The Interpretation of the numerical values will be made by medical professionals only. The Interpretation of the numerical values will be made by medical professionals only. The device does not report any diagnosis but provides numerical values. It is the physician's The device does not report any diagnosis but provides numerical values. It is the physician's The device does not report any diagnosis but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers. responsibility to make proper judgments based on these numbers. LiveMetric LM1CS is also intended for use by a physician or other qualified healthcare provider is also intended for use by a physician or other qualified healthcare provider is also intended for use by a physician or other qualified healthcare provider for the calculation of heart rate and heart rate variability based on waveform analysis. or the calculation of heart rate and heart rate variability based on waveform analysis. or the calculation of heart rate and heart rate variability based on waveform analysis. INDICATIONS FOR USE and hemodynamic monitor. The LiveOne is intended to be used in patients who have a need for a noninvasive blood pressure The LiveOne is intended to be used in patients who have a need for a noninvasive blood pressure The LiveOne is intended to be used in patients who have a need for a noninvasive blood pressure The LiveOne is intended to be used on subjects 18 years old, who have a palpable radial pulse. be used on subjects 18 years old, who have a palpable radial pulse. be used on subjects 18 years old, who have a palpable radial pulse. Software is used to provide data to qualified medical professionals for the purpose of assessing Software is used to provide data to qualified medical professionals for the purpose of assessing Software is used to provide data to qualified medical professionals for the purpose of assessing the patients cardiac health via blood pressure readings taken during daily activity for the patients cardiac health via blood pressure readings taken during daily activity for the patients cardiac health via blood pressure readings taken during daily activity for up to a 24-

hour period. LiveOne is intended only for measurement and display; it makes no diagnosis. hour period. LiveOne is intended only for measurement and display; it makes no diagnosis. hour period. LiveOne is intended only for measurement and display; it makes no diagnosis. Page 5 of 28 CONTRAINDICATIONS The device is not indicated for use on patients who are:

under 18 years old; pregnant; do not have at least one wrist with skin intact; have a wrist circumference less than 6.19 in (155mm); have a wrist circumference greater than 8.26 in

(210mm); have implanted VADs or other mechanical circulatory support devices, whether intracorporal or extracorporeal; have impaired cognition; or have physical disability which Remove the wristband from the packaging and inspect for damage. If your monitor is damaged, DO NOT USE IT. Contact [phone number] if the wristband is damaged. inhibits the use of the device. RECEIVING AND INSPECTION YOUR PACKAGE INCLUDES:

1 LiveMetric LM1CS wristband 1 Charging Cradle 1 Charging Cable 1 User Manual Booklet 1 Quick Setup Card GENERAL WARNINGS Please carefully read all instructions before using the LiveMetric LM1CS device;

Do not useLiveMetric LM1CS without fully understanding instructions and safety information; Be aware that self-diagnosis of measurement results and self-treatment are dangerous!

wound;

wristband ;

You should NOT self-adjust medication based on the measurement results;

Be cautious when using LiveMetric LM1CSif you sufferfrom severe blood flow problems or blood disorders, as tightening the wristband may cause internal bleeding and/or damage blood flow in the internal blood vessels;

Do not apply the device on a wrist which is under medical treatment, or with an unhealed If any itching, skin rash and/or local edema appears, please remove and avoid using the The presence of any of the following medical conditions increases the risk of obtaining an Page 6 of 28 inaccurate reading using the device: shock; cardiac arrhythmias; atrial or ventricular premature beats; atrial fibrillation; arterial sclerosis; poor perfusion; vessel anomalies; very low blood pressure; pregnancy; diabetes; pre-eclampsia; renal diseases; having undergone breast or axillary lymph node removal operations; an arteriovenous shunt; an intravenous drip or blood transfusion; implanted electrical devices such as cardiac pacemaker; other medical electrical equipment attached to the body; a condition that may compromise circulation; severe blood flow problems or blood disorders (increased risk of bruising);

trembling or shivering;

Never charge the wristband while placed on wrist;

If the black casing of the device becomes heated, please remove the wristband immediately DO NOT use this device on newborns, infants, children, toddlers or persons who cannot and consult customer services;

express their intentions;

Do not use the wristband for any purpose other than measuring blood pressure;

Avoid using the device next to other device/s which emits electromagnetic fields; it may result in incorrect operation of the device;

Do not use the device with other medical, electrical equipment simultaneously;

Do not use the device where high frequency surgical equipment, magnetic resonance imaging (MRI), computerized tomography (CT) scanner or X-ray machine is operating;

Do not use the device near electromagnetic fields emission equipment, such as cellular Do not use the device where flammable gases (e.g. anesthetics gas, oxygen and hydrogen) or phones, microwave ovens or televisions;

flammable liquids (e.g. alcohol) are present;

parts, out of reach of infants and children;

The product contains small parts that may cause a choking hazard; keep the device, and its Do not attempt to open, disassemble, repair, modify or adjust the device by yourself; it may cause accidents, damage the device, cause inaccurate measurements, and void the user warranty;

Do not drop the unit on the floor, or subject it to extreme temperatures, high humidity, direct sunlight, dust or chemicals; this may damage the device;

Do not replace the battery on your own;

Page 7 of 28 Read and follow the Important information regarding Electro Magnetic Compatibility

(EMC) in the Technical Data Section;

Read and follow the Correct Disposal of This Product, in the Technical Data Section, when disposing of the device and any used accessories or optional parts. The device is not water resistant. Avoid water, rain or sweat from infiltrating into the device;

Do not use an alcohol-based or solvent agent to clean the device. Clean the device only with a soft, dry cloth. Clean the screen carefully with a damp cloth. Do not submerge any part of the LiveMetric LM1CS in water at any time;

Store the device and the components in a clean, dry and safe location. GENERAL PRECAUTIONS Do not subject the monitor to strong shocks, such as dropping the unit on the floor. Do not submerge the device or any of the components in water. Store the device and the components in a clean, safe location. Changes or modification not approved by the manufacturer will void the user warranty. Do not disassemble or attempt to repair the unit or components. This may cause an inaccurate reading as well. Do not use the device outside the specified environment. It may cause an inaccurate reading. Dispose of the device, components and optional accessories according to applicable local regulations. Unlawful disposal may cause environmental pollution. Do not use the device in a moving vehicle such as in a car or on an airplane. Do not take measurements for30 minutes after bathing, drinking alcohol or caffeine, smoking, exercising or eating. Page 8 of 28 SAFETY SYMBOLS USED IN THIS YMBOLS USED IN THIS PRODUCT LABELING Manufacturer:

Manufacturer:

LiveMetric (Medical) SA LiveMetric (Medical) SA , Luxembourg Luxembourg Read this manual before Read this manual before use use Type BF Applied Part Type BF Applied Part o 55 C 131 F o 85

1,008 hPa o

-5 o

-23 C F 15

700 hPa IP22 Caution: Consult user Caution: Consult user manual manual ingress Protection ingress Protection Catalogue Number Catalogue Number Serial Number Serial Number Internally Powered Internally Powered Storage and Storage and Transportation Transportation Temperature Limits Temperature Limits Storage and Storage and Transportation Humidity Transportation Humidity Limits Limits Storage and Storage and Transportation Transportation Atmospheric Pressure Atmospheric Pressure Limits Limits Keep away from heat Keep away from heat Keep package dry Keep package dry Quantity Quantity CE Mark CE Mark Unique Device Unique Device Identification Identification FCC ID: 2AQVELM1 FCC ID: 2AQVELM1CS Single Patient Use Single Patient Use Single Patient Use BEFORE TAKING BLOOD PRESSUR TAKING BLOOD PRESSURE MEASUREMENTS To ensure a reliable blood pressure measurement blood pressure measurement, follow these recommendations:

, follow these recommendations:

Avoid eating, drinking alcohol, smoking, exercising, and bathing for 30 minutes Avoid eating, drinking alcohol, smoking, exercising, and bathing for 30 minutes Avoid eating, drinking alcohol, smoking, exercising, and bathing for 30 minutes before taking a measurement. Rest for at least 5 minutes before taking the before taking a measurement. Rest for at least 5 minutes before taking the before taking a measurement. Rest for at least 5 minutes before taking the Page 9 of 28 measurement. Stress raises blood pressure. Stress raises blood pressure. Avoid taking measurements during stressful times. Avoid taking measurements during stressful times. The wristband can be applied to your left or right wrist. can be applied to your left or right wrist. Measurements should be taken in a quiet place. Measurements should be taken in a quiet place. Position the sensors on the most palpable point on the wrist, and have your arm rested on sensors on the most palpable point on the wrist, and have your arm rested on sensors on the most palpable point on the wrist, and have your arm rested on a table throughout the measurement. oughout the measurement. Remain still and do not talk during the measurement. Remain still and do not talk during the measurement. Keep a record of your blood pressure and pulse readings for your physician. A single Keep a record of your blood pressure and pulse readings for your physician. A single Keep a record of your blood pressure and pulse readings for your physician. A single measurement does not provide an accurate indication of your true blood pressure. measurement does not provide an accurate indication of your true blood pressure. measurement does not provide an accurate indication of your true blood pressure. You need to take and record several readings over a period of time. Try to measure take and record several readings over a period of time. Try to measure take and record several readings over a period of time. Try to measure your blood pressure at the same time each day for consistency. your blood pressure at the same time each day for consistency. KNOW YOUR MONITOR WRISTBAND CHARGING CLIP

(Insert Image) CHARGING CABLE

(USB-C to USB) Insert Image-

INSTRUCTION MANUAL USING THE WRISTBAND FOR THE RISTBAND FOR THE FIRST TIME Page 10 of 28 CHARGING THE BATTERY We recommend charging the battery to a full 100% prior to use. The battery takes about 3 hours We recommend charging the battery to a full 100% prior to use. The battery takes about 3 hours We recommend charging the battery to a full 100% prior to use. The battery takes about 3 hours to charge fully when the battery is empty. Once fully charged, the battery will last for to charge fully when the battery is empty. Once fully charged, the battery will last for to charge fully when the battery is empty. Once fully charged, the battery will last for approximately 5-7 days depending on frequency of use. 7 days depending on frequency of use. To charge the device - plug the USB the USB-C end of the charging cable into the charging clip. C end of the charging cable into the charging clip. Plug the USB end of the charging cable into a USB adapter or power source. Plug the USB end of the charging cable into a USB adapter or power source. Plug the USB end of the charging cable into a USB adapter or power source. Attach the charging clip to the back of the watch face by pinching the sides of the charging clip. Attach the charging clip to the back of the watch face by pinching the sides of the charging clip. Confirm that the wristband is charging by looking at the LED light on the button of the device. Confirm that the wristband is charging by looking at the LED light on the button of the device. Confirm that the wristband is charging by looking at the LED light on the button of the device. This light will alternate between red and purple flashes when the wristband is charging. The light This light will alternate between red and purple flashes when the wristband is charging. The light This light will alternate between red and purple flashes when the wristband is charging. The light will turn solid green when the wristband is fully charged. ill turn solid green when the wristband is fully charged. To check the percentage of battery charge remaining, click the watch face button to scroll To check the percentage of battery charge remaining, click the watch face button to scroll To check the percentage of battery charge remaining, click the watch face button to scroll through the wristband options (

the wristband options (e.g. time, last blood pressure measurement, last heart rate, etc.)

. time, last blood pressure measurement, last heart rate, etc.) until you get to the percentage of battery remaining, indicated by the icons below:

ou get to the percentage of battery remaining, indicated by the icons below:

ou get to the percentage of battery remaining, indicated by the icons below:

DOWNLOAD LIVEMETRIC APP 1. Go to your app store (Google Play or Apple Go to your app store (Google Play or Apple Store) 2. Download the LiveMetric App. the LiveMetric App. 3. Once installed Press Open. Open. 4. The app will then request permission to access The app will then request permission to access your location and to run in the background. your location and to run in the background. For best results, we recommend setting your location permissions to Always Allow and For best results, we recommend setting your location permissions to Always Allow and For best results, we recommend setting your location permissions to Always Allow and the background permissions to Allow. the background permissions to Allow. 5. Authenticate your device. You will receive a four Authenticate your device. You will receive a four-digit code on your wristband. Enter digit code on your wristband. Enter this code on the Code Confirmation screen on the app, then click Next. code on the Code Confirmation screen on the app, then click Next. code on the Code Confirmation screen on the app, then click Next. 6. Watch the device tutorial to learn about the features of your wristband. Watch the device tutorial to learn about the features of your wristband. Watch the device tutorial to learn about the features of your wristband. 7. Once you have watched the tutorial, click Continue. Once you have watched the tutorial, click Continue. Note:If you do not allow the app to run in the backgrou If you do not allow the app to run in the background, then the wristband may not be able to nd, then the wristband may not be able to take automatic blood pressure measurements throughout the day. Please, allow the app to run in take automatic blood pressure measurements throughout the day. Please, allow the app to run in take automatic blood pressure measurements throughout the day. Please, allow the app to run in the background for optimal performance. the background for optimal performance. SETUP THE LIVEMETRIC APP 1. Launch the LiveMetric App and read Launch the LiveMetric App and read Terms of Agreement on the screen. on the screen. Page 11 of 28 2. Check the box to confirm that you agree to terms (Note: device cannot be operated 3. On the apps Welcome Screen, press I have the wristband to start operating your without agreeing to terms of use) wristband. demographic data lb/Kg and sm/ft 4. Create your account on the profile screen; first select the units you want to fill the 5. Fill all your profile demographics: Gender, Date of Birth, Height, Weight (Note:

demographic data is necessary to ensure accuracy of blood pressure measurements) 6. Confirm that your wristband is charged, then press Im Good, Lets Continue. PAIR YOUR WRISTBAND WITH A SMARTPHONE Before pairing your wristband, make sure the mobile phone battery level is greater than 30%. Make sure your device is not connected to the charger before starting the next steps. 1. Enable Bluetooth on your smartphone. 2. Turn on your device, by pressing the square button on the watch face. 3. Pair your device via Bluetooth. To do this, first make sure that Bluetooth is on in your phones settings. Then, return to the app screen, and activate the device by double tapping on the watch face. The app will automatically search for Bluetooth devices. 4. The app will display a list of Bluetooth devices found during pairing. Click the toggle next to the device named LiveMetric to select this device. Then, press Pair with device at the bottom of the screen. 5. Confirm that your wristband connected successfully by looking at the LED light on your wristband. While pairing, this light should flash blue. Once it is successfully connected to your smartphone, this light will be solid blue (no longer flashing). 6. Upon pairing the wristband to your smartphone, the app should automatically begin updating the wristband to the most current firmware version if the firmware is out of date. 7. You have completed the set-up process for the wristband and app! Now, you are ready to use the device. 8. Watch the Placement Tutorial to learn how to put on your wristband properly. This step is crucial to making sure that you get accurate blood pressure readings! Once you have finished watching the tutorial, press Continue. Note:LiveMetric is the only app that we recommend that you use with your deviceto transfer Page 12 of 28 data correctly. If you change the smart device that was paired with your device, delete the pairing information from your old smart device to avoid communication issues. PLACINGTHE WAISTBAND Blood pressure can differ between the right and left wrists,LiveMetric recommends always using the same wrist when measuring blood pressure. Consult with your physician to determine which wrist you should use for your measurements. Determine the correct position of the deviceon your wrist by running your forefinger and middle finger down your thumb to your wrist. You should feel your pulse. Place the wristband sensors onto the pulsing artery, making sure the band is as close as possible to the bottom of your palm. Tighten your wristband so that it is snugly-fit not too tight and not too loose. Your wristband should not move or slide from its position. Select right or left to indicatewhich wrist you placed the band on pairing page and press next. The app will also give you feedback about how well-placed the wristband is. You may need to make adjustments to the placement both during set-up and periodically. Select which arm your wristband is placed on, left or right. Then, click Continue. On the Placement screen, you will see four signals, one from each of the wristband sensors. Good, high quality signals appear green and poor, low quality signals will be red. For good wristband placement, ensure that at least two of the signals are good (i.e. green). Watch the Measurement tutorial to learn how to take blood pressure measurements with your wristband. Once you have watched the tutorial video, click Continue. Note:If your device is not connected to your selectedsmartphone when you take the measurements, the measurements taken in the last 72 hours will be saved locally and will be transferred to the smartphone once connected. TAKING YOUR FIRST MEASUREMENT 1. On the Measurement screen, press Start on the blue circle to begin taking a measurement. 2. The app will begin measuring your blood pressure. You will see your pulse wave displayed at the bottom of the screen during measurements. For best results, be silent and still during the measurement. 3. Once the measurement has been completed, the app will display your systolic and Page 13 of 28 diastolic blood pressure values, as well as, your heartrate. 4. After looking at your results, click Done, Go to app. USING YOUR DEVICE DAILY To get an accurate blood pressure reading, proper placement of the wristband is essential. Watch the Placement Tutorial video on the LiveMetric app for detailed instructions on how to wear the wristband. This video is accessible by clicking on Placement on the menu at the bottom of the app screen and then clicking the play symbol on the top right corner of the Placement screen. 1. Make sure thatthe deviceis correctly positioned on your wrist. If you are not sure, go to placement screen and verify that at list one of the signal lines is green. 2. Click continue and wait calmly until blood pressure values appear. Note:With normal daily activity, the wristband may move out of position. Be sure to check wristband placement periodically to ensure proper placement. If the wristband is not placed correctly, the device will fail to measure your blood pressure no results will appear on the screen. RECOMMENDED METHOD TO BLOOD PRESSURE MEASUREMENTS To take a manual blood pressure measurement, you should be relaxed and comfortably seated in a room with an ambient temperature. Keep still, breath calmly and avoid movements. Keep your upper arm next to the body, with your elbow bent so that your arm is approximately at a 90-degree angle. Sit in a comfortable chair with your back supported. Keep your feet flat and your legs uncrossed. Relax your wrist and hand. Do not bend your wrist back, clench your fist or bend your wrist forward.. Activities, such as, bathing, drinking alcohol or caffeine, smoking, exercising, and eating may raise blood pressure. Stressful situations may also raise blood pressure. For the most accurate measurements, wait at least thirty minutes after any of these activities or after stressful events to take blood pressure measurements. Rest for at least 5 10 minutes before taking a blood pressure measurement. You should refrain from speaking and moving while taking manual measurements. A single measurement is NOT an accurate indication of your true blood pressure. You Page 14 of 28 need to take several readings over a period of time to determine your true blood pressure. Speak to your physician if you have questions about how frequently you should be monitoring your blood pressure. Remember to generate blood pressure monitoring reports for your physician prior to meeting with him/her in the clinic. You can do this on the LiveMetric app. The instructions for how to generate reports can be found in section 6 of this manual. PERFORM MANUAL MEASUREMENT Go to the Home screen on the LiveMetric app by clicking Home icon on the bottom Sit still in the position described above, then click the circle that says Measure in the dashboard. middle of thescreen. Breath calmly as acircle will slowly spin on the screen and your pulse wave will be displayed on the app screen while the wristband is taking a measurement. If you wish to stop this measurement at any time, click Stop. Once the wristband completes a measurement, the app will display your systolic and diastolic blood pressure values along with your heart rate. Note:These instructions apply only to measurements taken manually. For automatic blood pressure measurements in which you set the frequency with which the wristband automatically measures your blood pressure, you will not need to stop daily activities to record your blood pressure. WARNING!

physician. DO NOT adjust medication based on your readings from this blood pressure device. Take medication only as prescribed by your physician. ONLY a physician is qualified to diagnose and treat high blood pressure. NEVER diagnose or treat yourself based on your readings. ALWAYS consult with your SCHEDULING BACKGROUNDBLOOD PRESSURE MEASUREMENTS To be able to take blood pressure measurements automatically using your wristband, you must allow the LiveMetric app to run in the background in your phones app settings. Click on the menu button on the top left corner of the app screen. When the menu Page 15 of 28 appears, click Scheduling. Click on the Background Checks section to set automatic monitoring frequency. This means that the wristband will automatically take measurements without notifying the user or requiring any input from the user. Click on the Night Mode section to set your average sleep times. RECORDING EVENTS Events include activities, such as, eating meals, taking medications, exercising, etc. You can create events on the LiveMetric app to determine what your blood pressure is before, during, or after certain activities. On the LiveMetric app, go to Create New Event. Enter a Title for your event. Select an Activity Type for your event from the dropdown menu. Set a time, date, and repetition frequency for the event. Set a location for the event. pressure reports you choose to generate. VIEWING READINGS AND GENERATEREPORTS Set a color for the event. This color will be displayed with an event marker on any blood To see your blood pressure readings, go to Monitor at the bottom of the app screen. You will see a graph showing your systolic blood pressure readings (top curve), your diastolic blood pressure readings (middle curve), and your heart rate values (bottom curve). You can choose to see your data either in List View or in Graph View by toggling between these two options, displayed on the top right of the app screen. You can filter the data you see by selecting the drop-down menus on the upper left corner of the app screen. These filters will let you see only specific subsets of your data. For instance, you can filter by Night to see only measurements taken at night, or you can filter by Event to see only measurements taken during a certain event. To generate a report of your data, click on the notepad icon on the top right corner of the Monitor screen on the app. Select Default Report or Custom Report based on which data you would like your Page 16 of 28 report to include. Note:Reports can be generated and sent automatically to family members, caretakers, physicians, etc. The type of report you generate for each person you share your data with can be customized, as stated in step 5. When you start wearing the wristband, you may want to consult with your physician to see which information they would recommend including in the report. NOTIFICATIONS To view notifications, click on the bell icon on the upper right corner of the apps Main screen. Here, you will see notifications about Bluetooth connectivity status, wristband battery status, etc. SETTINGS BLUETOOTH SETTINGS ENTERING BLUETOOTH PAIRING MODE blue (not flashing). DISCONNECTING YOUR WRISTBAND To pair your device to your smartphone, press and hold the wristband button for about 3 seconds, or until the LED light flashes blue. Your wristband is now in pairing mode. Once your device is successfully paired with your smartphone, the LED light on your wristband should appear a solid To unpair your wristband from your smartphone, click on the menu icon on the upper left corner of the apps Main screen. Go to Wristband. You will see the wristbands firmware version, battery level, and connectivity status displayed. Click Forget Wristband to disconnect the device. SELECTING WHICH WRIST THE BAND IS PLACED ON While we recommend always wearing the wristband on the same wrist, we understand that you may want to switch between wristband placement between arms. If you do so, you should indicate which wrist the band is being worn on by going to the Placement screen on the LiveMetric app and then toggling between Left and Right to indicate the proper placement arm. RESETTING YOUR WRISTBAND If your wristband freezes or is unresponsive for any reason, you may want to try resetting it. To reset the wristband, press and hold the button on the watch face for 15 seconds. NOTIFICATION/LED LIGHT SETTINGS Page 17 of 28 You may receive notifications from the LiveMetric app on your smartphone. Notification settings can be adjusted in the LiveMetric app by clicking on the menu icon on the upper left corner of the Main screen and then clicking on Notifications & Sounds. Adjust App and Device Notifications, as well as, Silent Mode settings by following on-

screen instructions. ERROR MESSAGES AND TROUBLESHOOTING TROUBLESHOOTING

problem Source Corrective actions 1. Cannot click Next Terms of Use Please check the box "I agree and 2. Cannot click Next Profile setting Please follow the error messages on Screen accept the terms of use"

Screen the screen 3. Pairing unsuccessful Pairing Screen Please check if the blue LED light is 4. Pairing unsuccessful Pairing Screen Please check if the blue LED light is on. If not, please follow the corrective actions of problems 6-8 on. If so, please remove the dongle located on the upper right side of the screen and re-insert it and 6-8, call customer service 5. Pairing unsuccessful Pairing screen After following corrective actions 3-4 6. No Blue LED Black Casing on Please double tap firmly on the black the wristband casing the wristband the wristband 30 seconds 7. No Blue LED Black Casing on Please charge the wristband 8. No Blue LED Black Casing on Please hold down the reset button for 9. Cannot place the wristband UI Please follow the illustrations and instructions on the screen 10. The wristband is inflicting pain Wristband Please loosen the wristband using the Page 18 of 28 11. The wristband keeps moving on Wristband Please tighten the wristband using the on the patients wrist. the patients wrist 12. None of the waveform lines are Wristband Try to reposition the wristband;

turning green inward, outward, toward palm, away buckle buckle from palm 13. The waveform lines are flat Wristband Allow a few seconds for the sensors'

every time the wristband is signals to adjust, and then see if a moved green waveform line appears 14. After multiple repositioning Wristband Check if the LED light is blinking attempts, no green waveform blue-green;

line has appeared 15. The Blue-Green LED light is Wristband Click Cancel and pair the device not blinking (following 14) only

(See Operating Instructions on how blue LED light is on. to pair) 16. The Blue-Green LED is not Wristband Click Cancel and double tap the blinking, and the Blue LED light is not on (following 14) casing to pair the device after the Blue LED is seen 17. Blue Green LED is not blinking Wristband Charge the wristband and Blue LED light is not on

(following 16); even after double tapping 18. Cannot place the wristband UI Please follow the illustrations and 19. The wristband is inflicting pain Wristband Please loosen the wristband using the 20. The wristband keeps moving on Wristband Please tighten the wristband using the on my wrist my wrist instruction on the screen buckle buckle 21. Unsure that the placement is Wristband Click Next to view the waveform Page 19 of 28 correct lines and follow the instructions on screen 22. 23. The LED has stopped blinking Wristband Click Cancel and start again What is ABPM Placement ABPM is a mode that allows you to Screen monitor a patient, automatically, in a clinical setting, for a predefined period of time. In this mode you can configure the monitoring parameters;

please refer to troubleshooting in ABPM Setting frequency of 10 /15/20 minutes in order to get a significant number of measurements measurement in each session of measuring, during the monitoring process 24. What is Single Mode Placement Single Mode allows you to monitor the Screen patients waveform line derived from the active sensor. Periodically you can update the BP and HR values 25. I don't have enough ABPM Setting Please note that if 1 hour is chosen as measurements Screen the total time, it is best to select a 26. What is timeout?

ABPM Setting How long the wristband should Screen attempt to get a successful 27. No value appears;

ABPM Please consider repositioning the I get "- -"

Measurement wristband 28. No value appears;

Please check that the patient is not I get "- -"

Measurement moving while the LED is blinking blue-green 29. No value appears;

Make sure the patient has rested before Screen ABPM Screen ABPM Page 20 of 28 I get "- -"

Measurement measurement has taken place Screen Screen Single Screen Single Screen 30. No value appears;

Wristband is not Please click Done to restart the I get "- -"

blinking session. The connection could not be 31. I got a pop-up message that the ABPM Please click Done to restart the connection cannot be restored Measurement session. The connection could not be restored restored. 32. Did not get any values;

Please reposition the wristband Waveform looks flat Measurement 33. Did not get any values;

Please check that the patient is not Waveform is irregular Measurement moving 34. Did not get any value;

Wristband is not Please click Done to restart the 35. The waveform line looks noisy Single Consider removing any blinking session. The connection could not be restored Measurement electromagnetic interference while Screen monitoring 36. I got a pop-up message that the ABPM Please click Done to restart the connection cannot be restored Measurement session. The connection could not be Screen restored 37. Did not get any values Measurement Please click Re-measure and follow 38. Did not get any values Measurement Please click Done and start the Screen actions 12-13 and onward Screen process of measurement from the beginning ERROR MESSAGES Page 21 of 28 Error Description Correction actions Please fill in day Cannot click Next on profile setting Please complete day of birth Please fill in Cannot click Next on profile setting Please complete month of birth Please fill in Cannot click Next on profile setting Please complete year of birth Please fill in Cannot click Next on profile setting Please select gender Please fill in Cannot click Next on profile setting Please complete weight Please fill in Cannot click Next on profile setting Please complete height Battery level is Cannot operate device Please charge the wristband Battery level is Error message appears Please Complete measurement and charge the wristband data screen missing month screen data missing year data screen missing gender screen data data data missing weight screen missing height screen critical please charge the wristband low please charge the wristband after current measurement MAINTENANCE Battery Low Error message from tablet Please charge the tablet Page 22 of 28 To protect this Device from damage, please use with CAUTION Being aware of the Changes or modifications not approved by the manufacturer will void the user warranty. DO NOT disassemble or attempt to repair this device or other components. following:

STORAGE In locations exposed to extreme temperatures, humidity, direct sunlight, dust or Store your device in a clean, safe location. Do not store your device:

If your device is wet. corrosive vapors such as bleach. In locations exposed to vibrations or shocks. CLEANING Do not use any abrasive or volatile cleaners. Use a soft dry cloth or a soft cloth moistened with neutral soap to clean your device, and then wipe them with a dry cloth. Do not wash or immerse your device in water. Do not use gasoline, thinners or similar solvents to clean your device. Do not use a wet cloth on the charging cableor the terminal of the charging clip. Stop using this device and consult with your physician if you experience skin irritation or WARNINGS!

discomfort. Prolonged rubbing and pressure may irritate the skin. Give your wrist a break by removing your device for a while after extended wear. Be careful not to let chemical products such as lotions, oils, skin creams or cosmetics collect on the band. If this happens, wipe them immediately, otherwise it may impact the material and lifetime of product. DISPOSAL Dispose of your device and other components according to applicable local regulations. Unlawful disposal may cause environmental pollution. SPECIFICATIONS Page 23 of 28 PERFORMANCE Accuracy of pressure: 3mmHg or 2% of reading Accuracy of Heart Rate: 4% of reading Measurement Unit: Systolic: 50-250 mmHg / Diastolic: 30-180 mmHg Measurement Range: Pulse Rate: 40-199 / minute SENSORS LiveMetrics LiveOne contains the following sensors:

Accelerometer, which tracks your motion patterns 4 pressure sensors MATERIALS The LiveOne LiveMetric wristband is made of a flexible, durable elastomer material, like that used in many sports watches, Silicon 60 shore A (Shin-Etsu Silicon CHN), and includes a stainless steel black anodized buckle. The black casing is made of black anodized aluminum. The upper antenna cover is made of PC. The bottom support is made of ABS. WIRELESS TECHNOLOGY LiveMetric LM1CS contains a Bluetooth 4.0 radio receiver. LiveMetric LM1CS contains a rechargeable, 1 cell lithium-polymer battery. BATTERY MEMORY 100 MB internal device memory WRISTBAND SIZE Wristband sizes are shown below. Please note that we recommend measuring the patients wrist prior to purchase as shown on the packaging. Large Fits a wrist between 7.1 - 8.26 inches (180 - 210 mm) in circumference Small Fits a wrist between 6.10 7.1 inches (155 - 180 mm) in circumference ENVIRONMENTAL CONDITIONS This equipment complies with FCC RF radiation exposure limits, set forth for an uncontrolled environment. TECHNICAL DATA Page 24 of 28 Operating Temperature 14 to 104 F

(-10 to 40 C)

-4 to 14 F 113 to 140 F

(45 to 60 C) Non-operating

(-20 to -10 C) Temperature Water Resistance IP22 Maximum Operating 28,000 feet Altitude

(8,534 m) ESD Ratings Electrostatic discharge V(ESD) 500V Recommended Operating Conditions Input voltage range 5V Input current 1A Battery Operating 3.7V Voltage FCC STATEMENT 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. 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 and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or Page 25 of 28 television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into 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. Caution: Any changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. IC Statement This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions:

(1) this device may not cause harmful interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Le prsentappareilestconforme aux CNR d'Industrie Canada applicables aux appareils radioexempts de licence. L'exploitationestautorise aux deux conditions suivantes :

(1) l'appareil ne doit pas produire de brouillage, et (2)l'utilisateur de l'appareildoit accepter tout brouillageradiolectriquesubi,mmesi le brouillageest susceptible d'encompromettrele fonctionnement. TRADEMARK STATEMENT The Bluetooth Smart word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by LiveMetric (Medical) S.A. is under license. Other trademarks and trade names are those of their respective owners. Apple, the Apple logo, iPad, and iPhone are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc. Android and Google Play are both trademarks of Google Inc. Samsung and Galaxy S are both registered trademarks of Samsung Electronics Co., Ltd.Limited WARRANTY Your LiveMetric, LM1CS, is warranted to be free from defects of material and workmanship appearing within 2 years from date of purchase, when used in accordance with the provided Page 26 of 28 instructions. We will, without charge, replace the unit if it is covered by the above warranty condition. Replacement is your only remedy, and our only responsibility, in terms of this warranty. To obtain warranty service, please contact our Customer Care line on [number] for the shipping address of the inspection center, and the return shipping and handling fee. Enclose the proof of purchase, and a letter with your name, address, contact number, and a brief description of the specific problem. Pack the product carefully to avoid damage during transit. THE ABOVE IS THE SOLE WARRANTY PROVIDED BY LIVEMETRIC IN CONNECTION WITH THIS PRODUCT, AND LIVEMETRIC HEREBY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS, FOR A PARTICULAR PURPOSE. IMPLIED WARRANTIES AND OTHER TERMS THAT MIGHT BE IMPOSED BY LAW, IF ANY, ARE LIMITED, IN DURATION, TO THE PERIOD OF THE ABOVE EXPRESS WARRANTY. LIVEMETRIC WILL NOT BE LIABLE FOR LOSS OF USE, OR ANY OTHER SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT LOSS, EXPENSE OR DAMAGE. This warranty provides you with specific legal rights, and you may have other rights, which vary from state to state. Some states do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply. Some states do not allow exclusion, or limitation, of incidental or consequential damages, so the above limitation my not apply. Page 27 of 28 MANUFACTURER INFORMATION:

LiveMetric (Medical) S.A. 40 Rue Glesener L1630, Luxembourg Device SN: LM1CS0011219C Device Revision: 002 User Manual Reference: IFU-LM1CS-001-C User Manual Revision: Rev.001 Page 28 of 28

26 mm F Livemetric P22 18m Model: LMICS CEORA FCC ID: 2AQVELMICS Input: DC SV, 14 F o10-PRD-u108-007 WoL Sip Made in China 013-PAD-LMICS-001-WES Manufacturer:

tivegtic (Medica) S.A, Cusembour Made in China SN=01411410421 12mm 26 mn LiveMetric P22 Model: LMICS CEORA FCC ID: 2AQVELMICS Input: DC 5V, 1A 00-PAD-LM1 68-007 -WBL Manufacturer LiveMetric (Medical) S.A, Curembourg Mate in China

LiveMetric (Medical) S.A. Date:2020/02/28 Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 To whom it may concern:

I, the undersigned, hereby authorize UL Verification Services Inc. to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by UL Verification Services Inc. on our behalf shall have the same effect as acts of our own. I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). In authorizing UL Verification Services Inc. As our representative, we still recognize that we are responsible to:

a) comply with the relevant provisions of the certification program;

b) c) d) e) make all necessary arrangements for the conduct of the evaluation, including provision for examining documentation and access to all areas, records (including internal audit reports) and personnel for the purposes of evaluation (e.g. testing, inspection, assessment, surveillance, reassessment) and resolution of complaints;

Make claims regarding certification only in respect of the scope for which certification has been granted;

Do not use our product certification in such a manner as to bring the Certification Division into disrepute and not make any statement regarding our product certification which the Certification Division may consider misleading or unauthorized;

Upon suspension or cancellation of certification, discontinue use of all advertising matter that contains any reference thereto and return any certification documents as required by the Certification Division;

f) g) h) i) j) Use certification only to indicate the products are certified as being in conformity with specified standards;

Endeavor to ensure that no certificate or report nor any part thereof is used in a misleading manner;

ensure that any reference to our product certification in communication media such as documents, brochures or advertising, complies with the requirements of the Certification Division;

keep a record of all complaints made known to us relating to the products compliance with requirements of the relevant standard and to make these records available to the when requested;

take appropriate action with respect to such complaints and any deficiencies found in products or services that affect compliance with the requirements for certification;

k) Document the actions taken. This authorization is valid until further written notice from the applicant. Sincerely Yours, Signed by:

Company Name: LiveMetric (Medical) S.A. Contact Name: Tomer Bentzion Title of Person: CEO Address: 40, rue Glesener L1630 Luxembourg

LiveMetric (Medical) S.A. Request for Confidentiality Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 Subject:

FCC ID: 2AQVELM1CS To Whom It May Concern:

Pursuant to the provisions of Sections 0.457 and 0.459 of the Commissions rules (47 CFR 0.457, 0.459), we are requesting the Commission to withhold the following attachments as confidential document from public disclosure indefinitely.

(1) Schematic Diagram

(2) Block Diagram

(3) Theory of Operation Above mentioned document contains detailed system and equipment description are considered as proprietary information in operation of the equipment. The public disclosure of above documents might be harmful to our company and would give competitor an unfair advantage in the market. It is our understanding that all measurement test reports, FCC ID label format and correspondent during certification review process cannot be granted as confidential documents and those information will be available for public review once the grant of equipment authorization is issued. Sincerely, Signature Company Name: LiveMetric (Medical) S.A. Contact Name: Tomer Bentzion Title of Person: CEO Address: 40, rue Glesener L1630 Luxembourg Date:2020.2.28