Related Manuals for MedNet HeartTrends
Summary of Contents for MedNet HeartTrends
- Page 1 User Manual The Effortless Stress Test Alternative Computerized Analysis of ECG Inter-beat Time Intervals...
- Page 2 User Manual Lev-EL HeartTrends App The symbol CE 0344 indicates compliance of this device with the Medical Device Directives 93/42/ EEC, 2007/47/CE. MedNet EC-Rep GmbH MedNet EC-Rep GmbH Borkstrasse 10 48163 Muenster, Germany Lev El Diagnostics of Heart Diseases Ltd.
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Page 3: Table Of Contents
ABLE 10. MAINTENANCE AND SERVICE ....................27 10.1. G ............................. 27 ENERAL 10.1.1. Obtaining Service for the HeartTrends App ..............27 11. WEB DASHBOARD ........................ 28 11.1. G ............................. 28 ENERAL © 2020 Lev EL Diagnostics of Heart Diseases Ltd. - Page 4 User Manual Lev-EL HeartTrends App 11.1.1. Accessing the Web Dashboard ..................28 11.1.2. Adminstrator Access Privileges to Web Dashboard ............28 APPENDIX I: INSTALLATION GUIDE ..................... 29 APPENDIX II: WEB DISTRIBUTOR & CLINIC MANAGER GUIDE ............30 ............................30 ENERAL 1.1.
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Page 5: Introduction
Lev-EL HeartTrends App 1. INTRODUCTION 1.1. THE HEARTTRENDS SYSTEM The Lev El HeartTrends® System is a software application designed for the computerized analysis of RR intervals time series, for diagnosis of myocardial ischemia related to coronary artery disease. The system consists of a Lev El- App running on an approved Platform and a cloud-based Server System. -
Page 6: About This User Manual
1.2.ABOUT THIS USER MANUAL This User Manual provides the information necessary to operate the HeartTrends App in a safe and efficient manner. Please read and thoroughly understand this User Manual before operating the system. If any part of this User Manual is not clear, contact customer support. -
Page 7: Glossary
Lev-EL HeartTrends App 1.3.GLOSSARY Clinic: The HeartTrends customer -- this is the entity that purchases tokens (or credits) from a distributor to perform data analysis. Physician or Technician: The person who interacts with the subject, helps the subject put on and remove the Heart Rate Recording Sensor, and uses the App to control the data monitoring/collection/analysis process. -
Page 8: Safety
The HeartTrends Report is the final output of the system used by the physician to evaluate the subject in conjunction with the subject's health history, symptoms, and other diagnostic tests, as well as the physician's clinical judgment. -
Page 9: Introduction To Hearttrends
3.1.DESCRIPTION OF DEVICE The HeartTrends System is intended to provide detailed analysis of Recorded RR interval Data. The HeartTrends System consists of the HeartTrends App and the HeartTrends Server, and is used with a Heart Rate Recording Sensor. The purpose of the Heart Rate Recording Sensor is to gather information about the subject's heartbeat. -
Page 10: Process Description
Lev-EL HeartTrends App 3.2.PROCESS DESCRIPTION The HeartTrends System is designed to allow the gathering and analysis of RR Interval data from the Heart Rate Recording Sensor. Using the HeartTrends App, the user logs into the App and enters subject information such as name and ID number. -
Page 11: Process Flow Diagram
User Manual Lev-EL HeartTrends App 3.3.PROCESS FLOW DIAGRAM The overall process flow of the HeartTrends System is shown below. Set up the App on the See Section 4. Set up the user’s device (one-time HeartTrends App. setup by installer) Place the Heart Rate See Section 5.1. -
Page 12: Set Up The Hearttrends App
4.2. RUN THE APP AND LOG IN The first time that you use the HeartTrends App, you will be asked to enter your user and password information. The user and password information can be obtained from your HeartTrends distributor. -
Page 13: Hearttrends Main Screen
App menu – see Section App Menu Bluetooth status – see Section Connect by Pressing the Bluetooth Icon Retrieve test residing on sensor – see Section 6. Retrieve the HeartTrends Test Begin a new test – see Section Perform a Test ©... -
Page 14: App Menu
User Manual Lev-EL HeartTrends App 4.4. APP MENU The App menu in in the upper left corner provides the following options: Display the main screen, which allows running a new test, or viewing previous test results View the test time, and change the belt type and language. - Page 15 User Manual Lev-EL HeartTrends App Press the back button to continue. Note: If Test time is less than 20 minutes (the recording sensor was removed prior to the conclusion or possibly erratic, intermittent contact between the skin and the sensor electrodes), the system will calculate a score which may be inconclusive.
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Page 16: Perform A Test
User Manual Lev-EL HeartTrends App 5. PERFORM A TEST Performing a test requires helping the subject put on the Heart Rate Recording Sensor, connecting the App to the sensor, and using the App to enter subject information and begin the test. -
Page 17: Connect By Pressing The Bluetooth Icon
User Manual Lev-EL HeartTrends App 5.2.2. CONNECT BY PRESSING THE BLUETOOTH ICON Press on the Bluetooth icon on the top right of the screen: The Platform’s Bluetooth and Location Services (GPS) must be enabled. If not, you will be prompted. -
Page 18: Starta Test
User Manual Lev-EL HeartTrends App 5.3. START A TEST Press the Start test button to start the test. Main screen The App will display a screen showing a list of sensors, as explained in Section 5.2.2. Connect by Pressing the Bluetooth Icon. -
Page 19: Enter Subject Information And Begin Test
User Manual Lev-EL HeartTrends App 5.4. ENTER SUBJECT INFORMATION AND BEGIN TEST The next step is to enter the subject’s name and ID into the App. Optionally, you may also enter information on the subject’s health history (strongly encouraged). 5.4.1. ENTER SUBJECT’S IDENTIFYING INFORMATION After you press Start Test, the following screen will display: Please enter the subject’s name and ID. -
Page 20: Enter Subject's Medical Information (Optional)
This information is solely for the purpose of helping the physician to evaluate the result in the HeartTrends Report in context with the other well-known cardiac risk factors such as smoking, cholesterol, high blood pressure, etc. We strongly recommend filling in this information to maximize subsequent medical evaluation of the subject. - Page 21 User Manual Lev-EL HeartTrends App The previous screen will redisplay: Press START TEST to begin the test. The test may be aborted by pressing “Abort test” after which all test data will be erased from the recording device with no charge for the test.
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Page 22: Retrieve The Hearttrends Test
“Wake” the Sensor and Section5.2.2. Connect by Pressing the Bluetooth Icon. A screen similar to the following will display: Press YES to request the submit HeartTrends test for analysis. Note that this charges one test token. 6.2. INTERMEDIATE SCREENS While the test is being processed, some intermediate screens may display momentarily: 6.3. -
Page 23: Analyze The Hearttrends Test Result
User Manual Lev-EL HeartTrends App 6.4. ANALYZE THE HEARTTRENDS TEST RESULT Caution: The test score is only one of many factors relating to subject health and must be put into context by a physician’s interpretation. Following are some general examples of test scores: ... -
Page 24: Review Previous Hearttrends Reports
It is important to note that no personal subject information is transmitted outside of the HeartTrends System adhering to GDPR policy for data privacy. You may read more about the Privacy Pollcy at this link: www.heartrends.com/privacy-policy. -
Page 25: The Settings Screen
Choose device type – the type of measuring device used to collect subject heartrate data. Show HeartTrends Score on screen –displays the actual numeric score rather than “test completed…” Mandatory entry of Subject Health History –to force entry of optional data for clinic records Select your weight unit –... -
Page 26: Troubleshooting
User Manual Lev-EL HeartTrends App 9. TROUBLESHOOTING 9.1.TROUBLESHOOTING TABLE The following chart lists typical conditions that may occur with the HeartTrends App. Condition Possible Cause Recommended Action Moisten the 2 contact points on the strap with saliva, water, or electrode gel to improve conductivity. -
Page 27: Maintenance And Service
HeartTrends does not require maintenance or calibration on a routine basis. 10.1.1. OBTAINING SERVICE FOR THE HEARTTRENDS APP For questions regarding use of the HeartTrends App, please contact your distributor or Lev El Diagnostics of Heart Diseases Ltd. at support@HeartTrends.com. -
Page 28: Web Dashboard
Intended for large clinics and distributors to manage all the tests performed within the organization from a single location. With this Web Dashboard, users may request old HeartTrends reports, sort subjects by various criteria, and obtain a spreadsheet suitable for further, in-depth, data analysis or integration into electronic patient records. -
Page 29: Appendix I: Installation Guide
Purchase a Heart Rate Recording Sensor (for example: TICKRx by Wahoo Fitness) Download the HeartTrends App from the Google or Apple Play Store by searching for ‘HeartTrends’ a. Be sure to Accept all installation requests such as access to memory and location. -
Page 30: Appendix Ii: Web Distributor & Clinic Manager Guide
User Manual Lev-EL HeartTrends App APPENDIX II: WEB DISTRIBUTOR & CLINIC MANAGER GUIDE 1. GENERAL For distributing and managing Examination Test Tokens, adding new clinics, individual users, revoking privileges and maintaining privacy. 1.1. ACCESS Distributors and Clinic Managers may login to the Web Client account from the Distributor tab of the HeartTrends website: www.heartrends.com/distributor-secure-login...
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