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USER GUIDE

28

Intended Use

Compliance Statement

This digital blood pressure monitor was designed to measure the blood pressure and
heartbeat rate of adults with an arm circumference of 9–17 inches (22–42 cm).

This device is intended for indoor, home use.

Contains FCC ID: XMR201707BG96

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.

California Proposition 65 Warning

THIS PRODUCT CONTAINS CHEMICALS KNOWN TO THE STATE OF CALIFORNIA TO CAUSE

CANCER AND BIRTH DEFECTS OR OTHER REPRODUCTIVE HARM.

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Summary of Contents for HT900

Page 1: ...Blood Pressure Monitor User Guide START STOP ST ...

Page 2: ...ng Started 6 Components of the Device 7 Installing the Batteries 8 Securing the Cuff 9 Taking a Measurement 11 Caution 13 Systolic and Diastolic Blood Pressure 14 Standard Blood Pressure Classification 15 Irregular Heartbeat Detector 16 Precautions 17 ...

Page 3: ...bleshooting 20 Error Codes 22 Maintenance 24 Symbols 25 Technical Specifications 26 Intended Use 28 Compliance Statement 28 EMC Guidance 29 Complied Standards List 33 Manufacturing Information 35 Contact Information 35 ...

Page 4: ...estyle choices It comes with the Livongo connected blood pressure monitor and arm cuff as well as anytime access to expert coaches personalized insights reports and much more If you have any questions please call Livongo Member Support at 800 945 4355 or email us at membersupport livongo com We re available 24 hours a day 7 days a week ...

Page 5: ...nload it from the iOS App Store or Google Play Store The app will be your home base for the Livongo program Once you log in to the app tap GET STARTED on the Livongo program card on the home screen Follow the steps for setting up your blood pressure monitor or review the instructions on the next pages ...

Page 6: ...Arm Cuff Cuff Tube Start Stop Button Display Cuff Tube Connector Battery Compartment Battery Cover Systolic Pressure Diastolic Pressure Pulse Rate Irregular Heartbeat Indicator Component list of pressure measuring system Cuff Air pipe PCBA Pump Valve ...

Page 7: ...batteries 4 Slide the battery door closed Caution Do not insert the battery with the polarities in the wrong direction Use only 4 Duracell AA alkaline batteries with this device Do not use other types of batteries Do not use new and used batteries together Remove the batteries if the device will not be used for three months or more Do not dispose of batteries in fire If battery fluid should get on...

Page 8: ...our left upper arm by removing or adjusting clothing and jewelry Make sure blood flow is not constricted by a rolled up sleeve 3 Open the cuff and loosen fully 4 Orient the cuff so that the tube exits toward your hand 5 Place your arm through the cuff loop with your palm facing up START STOP ...

Page 9: ...f tube exit with the center of your arm Ф 8 Tighten the cuff evenly around your arm by pulling on the end make sure the Ф marker stays aligned with the center of your arm 9 Wrap the end of the cuff over your arm to secure it in place Don t make it too tight allow a finger to fit between the cuff and your arm 1 inch 2 3 cm ...

Page 10: ...as your heart Sit up straight and rest your feet flat on the ground Make sure the tube is not kinked or pinched 2 Press the START STOP button on the device to turn it on 3 Wait for the device to power on and perform the measurement while inflating the cuff Try not to speak or move during this time 4 When the measurement concludes results are shown on the display and the cuff automatically deflates...

Page 11: ...seconds If the device detects an irregular heartbeat the display will show this indicator along with the measurement results While this may not be a reason for immediate concern contact your primary care provider if you see this symbol frequently The first time setup in a new location could take 1 to 5 minutes to locate cellular tower connectivity This device measures blood pressure using the osci...

Page 12: ...s device is not suitable for use on patients with implanted electrical devices such as cardiac pacemakers or defibrillators This device is not suitable for use on patients with preeclampsia premature ventricular beats atrial fibrillation peripheral arterial disease or those undergoing intravascular therapy or who have an arteriovenous AV shunt ...

Page 13: ...and pump blood out of the heart the blood pressure reaches its maximum value in the cycle which is called systolic pressure When the ventricles relax the blood pressure reaches its minimum value in the cycle which is called diastolic pressure Systolic Diastolic Blood discharging artery Blood entering vein Press Relax ...

Page 14: ...0 80 mmHg Blood Pressure Category Systolic mmHg upper Diastolic mmHg lower Normal Less than 120 and Less than 80 Elevated 120 129 and Less than 80 High Blood Pressure Hypertension Stage 1 130 139 or 80 89 High Blood Pressure Hypertension Stage 2 140 or higher or 90 or higher Hypertensive Crisis Consult your doctor immediately Higher than 180 and or Higher than 120 Caution Please consult a physicia...

Page 15: ...or there are four or more pulse intervals the difference between each interval and the average is more than the average value of 15 the irregular heartbeat symbol appears on the display when the measurement results appear Caution The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat was detected during measurement Usually this is NOT a cause for ...

Page 16: ... or strangulation if used improperly Do not apply the cuff on an arm that has an unhealed wound another medical device attached or an intravenous drip or a blood transfusion attached Do not use this device if you have pre eclampsia premature ventricular beats atrial fibrillation peripheral arterial disease if you are undergoing intravascular therapy if have an arteriovenous AV shunt or if you have...

Page 17: ...nce that may affect the accuracy of measurements A minimum distance of 1 ft 30 cm should be kept from such devices during measurement The device is not intended for use on extremities other than the arm or for any purpose other than measuring blood pressure and pulse rate Do not confuse self monitoring with self diagnosis This device allows you to monitor blood pressure Do not begin or alter medic...

Page 18: ... measurement as it may lead to an inaccurate result or excessive inflation of the cuff which may cause injury Accuracy of pressure measurement at 50 and 200 mmHg and the rate of air leakage from the system should be checked after repair maintenance and every two years of use The device must only be serviced and repaired by authorized service personnel At the request of authorized service personnel...

Page 19: ... them making sure the and polarity symbols on the batteries match those inside the battery compartment Cuff does not inflate display turns on Cuff not plugged in correctly Make sure the connector on cuff tube is plugged all the way into the device Cuff doesn t form a loop around arm Cuff not assembled To form a loop Pass the end of the cuff farthest away from the tubing through the long metal D ri...

Page 20: ... talk during measurement Measurement results differ from those measured at doctor s office Measurements taken in a medical professional environment white coat effect may affect your blood pressure Measurements taken in a more relaxed home environment may avoid effects experienced in clinical settings Continue taking readings as usual If in doubt contact a medical professional Error code shown afte...

Page 21: ...indicate a measurement error showing Er 3 on the display Configuration of this alarm condition does not change after replacing the batteries Alarm Priority Low Display delay 10ms Operator s position 11 81 in 30 cm to 39 37 in 1 m from the display Er 4 No cellular coverage Move to another area closer to a window Use the device at a location where you get a strong cellular signal with your mobile ph...

Page 22: ...tube is plugged into the monitor Retake measurement If this issue persists contact Livongo Member Support Er 21 Pulse not detected Confirm the cuff is secured correctly around your arm and the cuff tube is plugged into the monitor Retake measurement If this issue persists contact Livongo Member Support Er 22 Measurement error Check cuff placement and make sure the cuff tube is plugged into the mon...

Page 23: ...his system There are no parts of the system that are designated as repairable by service personnel The system uses delicate electrical components and an intricate air unit that could be damaged If you cannot fix the problem using the Troubleshooting instructions on pages 20 21 contact Livongo Member Support ...

Page 24: ...it for electronic recycling Manufacturer REF Reference number Complies with FCC regulations Serial number IMEI Upper and lower limits of relative humidity IP21 Ingress protection against solid objects of 12 5 mm or greater and vertically falling water drops Caution symbol Follow instructions for use Upper and lower limits of pressure Direct current Keep dry Keep away from sunlight ...

Page 25: ...ange Systolic pressure Diastolic pressure Pulse rate 60 230 mmHg 8 0 30 7 kPa 40 130 mmHg 5 3 17 3 kPa 40 199 beats min Rated Cuff Pressure 0 299 mmHg 0 399 hPa Accuracy Pressure Pulse 3 mmHg 0 4 kPa 5 Working Conditions Temperature Relative humidity Pressure 41 F 104 F 5 C 40 C 15 90 non condensing 70 106 kPa ...

Page 26: ...line AA batteries Cuff Size 9 17 inches 22 42 cm Device Weight 274 g excluding batteries Dimensions 102 x 143 x 73 mm International Protection IP21 Applied Part Type BF Software Version Extended Lifetime Battery Life A01 5 years or 10 000 measurements may vary based on usage conditions 50 60 measurements may vary based on usage conditions ...

Page 27: ...ntains FCC ID XMR201707BG96 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 California Proposition 65 Warning THIS PRODUCT CONTAINS CHEMICALS KNOWN TO THE STATE OF CALIFORNIA TO CAU...

Page 28: ... the other equipment should be observed to verify that they are operating normally Warning Use of accessories transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation Warning Portable RF communications equipment incl...

Page 29: ...e excepted service life 2 Guidance and manufacturer s declaration electromagnetic emissions and immunity Guidance and Manufacturer s Declaration Electromagnetic Emissions Emissions test Compliance RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class B Harmonic emissions IEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions IEC 61000 3 3 Not applicable ...

Page 30: ...plicable Not applicable Surge IEC61000 4 5 Not applicable Not applicable Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Not applicable Not applicable Power frequency magnetic field IEC 61000 4 8 30 A m 50Hz 60Hz 30 A m 50Hz 60Hz Conduced RF IEC61000 4 6 Not applicable Not applicable Radiated RF IEC61000 4 3 10 V m 80 MHz 2 7 GHz 80 AM at 1 kHz 10...

Page 31: ...8 0 3 27 450 430 470 GMRS 460 FRS 460 FM c 5kHz deviation 1kHz sine 2 0 3 28 710 745 780 704 787 LTE Band 13 17 Pulse modulation b 217Hz 0 2 0 3 9 810 870 930 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation b 18Hz 2 0 3 28 1720 1845 1970 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217Hz 2 0 3 28 2450 2400 2570 Bluetooth WLAN 802 ...

Page 32: ... EN 60601 1 11 2015 IEC 60601 1 11 2015 Medical electrical equipment Part 1 11 General requirements for basic safety and essential performance Collateral standard Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment Electromagnetic compatibility EN 60601 1 2 2015 IEC 60601 1 2 2014 Medical electrical equipment Part 1 2 General require...

Page 33: ... 6 General requirements for basic safety and essential performance Collateral standard Usability IEC 62366 1 2015 Medical devices Part 1 Application of usability engineering to medical devices Software life cycle processes EN 62304 2006 AC 2008 IEC 62304 2006 A1 2015 Medical device software Software life cycle processes Bio compatibility ISO 10993 1 2009 Biological evaluation of medical devices Pa...

Page 34: ...Medical Electronics Co Ltd Zone B No 105 Dongli Road Torch Development District Zhongshan 528437 Guangdong China Manufactured for Livongo Health Inc 150 West Evelyn Ave Suite 150 Mountain View CA 94041 Livongo Member Support 800 945 4355 membersupport livongo com 2021 Livongo All rights reserved ...

Page 35: ...USER GUIDE 36 ...

Page 36: ...ur Welcome Kit includes 1 Blood Pressure Monitor 1 Blood Pressure Arm Cuff Accessories applied part 1 User Guide 1 Quick Start Guide 1 Travel Case 4 AA Batteries Detachable parts PL05201 Rev D March 2021 ...

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