Livongo HT900 User Manual

Hide thumbs

Table Of Contents

Table of Contents

Quick Links

Blood Pressure Monitor

User Guide

Table of Contents

Summary of Contents for Livongo HT900

Page 1 Blood Pressure Monitor User Guide...
Page 2: Table Of Contents
The Livongo Program . . . . . . . . . . . . . . . . . . .
Page 3 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Error Codes .
Page 4: The Livongo Program
The Livongo Program Welcome to Livongo! This new approach to managing high blood pressure makes it easy to improve your lifestyle 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.
Page 5: Getting Started
Getting Started Open the Livongo mobile app and log in. If you don’t have the app yet, download 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.
Page 6: Components Of The Device
Components of the Device Arm Cuff Cuff Tube Systolic Pressure Irregular Diastolic Heartbeat Cuff Tube Pressure Indicator Connector Pulse Rate Display Start/Stop Button Component list of pressure measuring system: • Cuff Battery Battery • Air pipe Cover Compartment • PCBA •...
Page 7: Installing The Batteries
Installing the Batteries If this is your first time using the device: 1 . Slide open the battery door on the back of the device. 2 . Install the batteries provided with the device. 3 . Follow the diagram inside the battery compartment for correct polarity —...
Page 8: Securing The Cuff
Securing the Cuff 1 . Plug the connector on cuff tube into the device. 2 . Expose your 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 .
Page 9 6 . Position the cuff’s edge about an inch (2-3 cm) above the elbow. Ф 7 . Align the Ф marker (located to the right of tube exit) with the center of your arm. 8 . Tighten the cuff evenly around your arm by 1 inch (2–3 cm) pulling on the end —...
Page 10: Taking A Measurement
Taking a Measurement 1 . Rest for at least 5 minutes, and avoid exercise and caffeine for at least 30 minutes before you take a reading. Lay your arm on a table with your palm facing up. The cuff should be at the same height as your heart. Sit up straight and rest your feet flat on the ground.
Page 11 Notes: 6 . The device automatically transmits measurement · If you wish to abort the measurement while the results. During this process an indicator is shown cuff is inflating, press and hold the START/ in the middle of the display. STOP button for 5 seconds.
Page 12: Caution
Caution · Do not use this device on infants. · This device is not suitable for use on pregnant women or women who might be pregnant. · This device is not suitable for use on patients with implanted electrical devices, such as cardiac pacemakers or defibrillators.
Page 13: Systolic And Diastolic Blood Pressure
Systolic and Diastolic Blood Pressure When ventricles (the part of the heart that pumps blood) contract 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.
Page 14: Standard Blood Pressure Classification
Standard Blood Pressure Classification The chart below is the standard blood pressure classification published by the American Heart Association (AHA). If you have been diagnosed with high blood pressure (hypertension), the AHA recommends keeping your blood pressure below 130/80 mmHg. Blood Pressure Category Systolic mmHg (upper#) Diastolic mmHg (lower#)
Page 15: Irregular Heartbeat Detector
Irregular Heartbeat Detector An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is measuring the systolic and diastolic blood pressure. During each measurement, the monitor records all the pulse intervals and calculates the average: If there are two or more pulse intervals, the difference between each interval and the average is more than the average value of ±25%, 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...
Page 16: Precautions
Precautions · Only use Duracell alkaline AA batteries with this device as these offer the longest battery life. Other brands may not be able to provide sufficient power for cellular data transmission. · Only use a cuff that has been approved by the manufacturer for this device model. ·...
Page 17 · The device may require up to 30 minutes to warm up/cool down from the minimum/maximum storage temperature before it is ready for use. · Do not use the device where flammable gases are present, or in environments with high oxygen concentration.
Page 18 · Do not touch the batteries during measurement. · This device is portable, but should not be operated in transit. · You can use this device to take your own measurement, no third-party operator is required. · In rare occasions, the device may remain inflated after a measurement. If this were to occur, make sure to disconnect the tube from the device to release pressure.
Page 19: Troubleshooting
Troubleshooting Problem Possible Reason Resolution Device doesn’t power on Batteries completely drained. Replace all batteries with new ones. when START/STOP button is pressed. Cuff does not inflate. Batteries inserted incorrectly. Remove batteries and reinstall them, (display remains off) making sure the + and - polarity symbols on the batteries match those inside the battery compartment.
Page 20 Problem Possible Reason Resolution Readings too high or low. Cuff not positioned correctly. Review instructions on Securing the Cuff, and retry measurement. Readings vary significantly between measurements. Movement during measurement. Place your arm on a table with your palm facing up. The cuff should be at the same level as your heart.
Page 21: Error Codes
Cellular connection error Er 6 Data transmission error Er 7 Internal error Replace all batteries with new ones. If the issue persists, contact Livongo Member Support. Er 9 Provisioning error Retake measurement. If this issue persists, contact Livongo Member Support. USER GUIDE...
Page 22 Cuff did not inflate 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 21 Pulse not detected Confirm the cuff is secured correctly around your arm and the cuff tube is plugged into the monitor.
Page 23: Maintenance
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. USER GUIDE...
Page 24: Symbols
Symbols Symbol Description Symbol Description Type BF applied part Temperature range Cuff circumference Do not dispose of this product as unsorted municipal waste; take it for electronic recycling. Manufacturer Reference number Complies with FCC regulations Serial number / IMEI Upper and lower limits of relative humidity Ingress protection: against solid objects of 12.5 IP21 mm or greater and vertically falling water drops...
Page 25: Technical Specifications
Technical Specifications Model HT900 Measurement Method Oscillometric measurement Measurement Range Systolic pressure: 60–230 mmHg (8.0–30.7 kPa) Diastolic pressure: 40–130 mmHg (5.3–17.3 kPa) Pulse rate: 40–199 beats/min Rated Cuff Pressure 0–299 mmHg (0–399 hPa) Accuracy Pressure: ±3 mmHg (0.4 kPa) Pulse: ±5%...
Page 26 Transport/Storage Temperature: -4°F–140°F (-20°C–60°C) Conditions Relative humidity: 0–93% non-condensing Power Supply 4 x 1.5V alkaline 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...
Page 27: Intended Use
Intended Use 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. Compliance Statement Contains FCC ID: XMR201707BG96 This device complies with part 15 of the FCC Rules.
Page 28: Emc Guidance
EMC Guidance The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments. Warning: Don’t use near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high. Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation.
Page 29 Technical description: 1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the 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...
Page 30 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Immunity Test IEC 60601-1-2 Compliance level Test level Electrostatic discharge (ESD) IEC 61000-4-2 ±8 kV contact ±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air ±2 kV, ±4 kV, ±8 kV, ±15 kV air Electrical fast transient/burst IEC 61000-4-4 Not applicable Not applicable...
Page 31 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Test Frequency Band Service Modulation Modulation Distance Immunity Test Radiated RF (MHz) (MHz) Level (V/m) IEC61000- 4-3 (Test 380-390 TETRA 400 Pulse modulation b) specifications 18Hz for ENCLOSURE PORT IMMUNITY 430-470 GMRS 460, FRS FM c) ±...
Page 32: Complied Standards List
Complied Standards List Risk EN ISO 14971:2012 / ISO 14971:2007 Medical devices – Application of risk management to management medical devices Labeling EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labeling, and information to be supplied. Part 1: General requirements User manual EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices General...
Page 33 IEC 80601-2-30:2009+A1:2013 Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers Clinical EN 1060-4:2004 Non-invasive sphygmomanometers – Part 4: Test procedures to determine the investigation overall system accuracy of automated non-invasive sphygmomanometers ISO 81060-2:2013 Non-invasive sphygmomanometers –...
Page 34: Manufacturing Information
(800) 945-4355 membersupport@livongo .com 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 2021 © Livongo. All rights reserved. USER GUIDE...
Page 35 USER GUIDE...
Page 36 Your 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...