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 ......................................
Using Your Device Daily...................................................................................................... 14 Recommended Method to Blood Pressure Measurements ....................................................... 14 Perform Manual Measurement ..................................................................................................... 15 WARNING! ..............................................................................................................................
Sensors ...................................................................................................................................... 24 Materials ................................................................................................................................... 24 Wireless Technology ................................................................................................................ 24 Battery .............................................................................
PLEASE READ THIS USER MANUAL THOROUGHLY BEFORE FORE USING THE WRIST WRISTBAND. KEEP THE USER MANUAL FOR FUTURE REFERENCE. REFERENCE FOR SPECIFIC INFORMATION ABOUT YOUR OWN BLOOD PRESSURE, CONSULT YOUR DOCTOR. INTRODUCTION Thank you for purchasing the LiveMetric LM1CS Blood Pressure Monitor. The LM1CSis a wristbandthat can be worn comfortably all day long, and is intended to measure your blood pressure and provide you with ssystolic, diastolic and heart rate values..
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 inhibits the use of the device.
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 conditio
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.
SAFETY SYMBOLS USED IN THIS PRODUCT LABELING o 55 Manufacturer: C LiveMetric (Medical) SA , Luxembourg o -5 C o -23 F 131 o F Storage and Transportation Temperature Limits 85 % Read this manual before use Transportation Humidity 15 Limits % 1,008 hPa Type BF Applied Part 700 hPa FCC ID: 2AQVELM1CS 2AQVELM1 Storage and Single Patient Use Caution: Consult user Storage and Transportation Atmospheric Pressure Limits Single Patient Use Keep away from heat manual IP22 Keep package dr
measurement. Stress raises blood pressure. Avoid taking measurements during stressful times. The wristband can be applied to your left or right wrist. 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 a table throughout oughout the measurement. Remain still and do not talk during the measurement. Keep a record of your blood pressure and pulse readings for your physician.
CHARGING THE BATTERY 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 approximately 5-7 7 days depending on frequency of use. To charge the device - plug the USB-C USB 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.
2. Check the box to confirm that you agree to terms (Note: device cannot be operated without agreeing to terms of use) 3. On the app’s Welcome Screen, press “I have the wristband” to start operating your wristband. 4. Create your account on the profile screen; first select the units you want to fill the demographic data lb/Kg and sm/ft 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.
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.
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.
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.
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.
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 app’s “Main” screen.
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 onscreen instructions. ERROR MESSAGES AND TROUBLESHOOTING TROUBLESHOOTING # 1. 2. 3.
on the patient’s wrist. 11. The wristband keeps moving on buckle Wristband the patient’s wrist 12. None of the waveform lines are Please tighten the wristband using the buckle Wristband turning green Try to reposition the wristband; inward, outward, toward palm, away from palm 13. 14.
correct lines and follow the instructions on screen 22. The LED has stopped blinking Wristband Click “Cancel” and start again 23. 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 24.
I get "- -" Measurement measurement has taken place Screen 30. No value appears; Wristband is not Please click “Done” to restart the I get "- -" blinking session. The connection could not be restored 31. 32. 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. Did not get any values; Single Please reposition the wristband Waveform looks flat Measurement Screen 33.
Error Description Correction actions Please fill in day Cannot click “Next” on profile setting Please complete day of birth data screen Please fill in Cannot click “Next” on profile setting missing month screen Please complete month of birth data Please fill in Cannot click “Next” on profile setting Please complete year of birth missing year data screen Please fill in Cannot click “Next” on profile setting missing gender screen Please select gender data Please fill in Cannot click “Nex
To protect this Device from damage, please use with CAUTION Being aware of the following: 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. STORAGE Store your device in a clean, safe location. Do not store your device: If your device is wet. In locations exposed to extreme temperatures, humidity, direct sunlight, dust or corrosive vapors such as bleach.
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 LiveMetric’s 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 CH
Operating Temperature 14° to 104° F (-10° to 40° C) -4° to 14° F Non-operating (-20 to -10° C) Temperature 113° to 140° F (45° to 60° C) 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.
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.
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.
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.
