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LifeWatch Research Services Arrhythmia Monitoring Overview.

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Presentation on theme: "LifeWatch Research Services Arrhythmia Monitoring Overview."— Presentation transcript:

1 LifeWatch Research Services Arrhythmia Monitoring Overview

2 LifeWatch Research Services – Business Model Physician & Advisory Board Staff Board Certified Cardiologists Electrophysiologists LifeWatch Information Systems State of the Art Telecomm and IS Network Scaleable, High Volume, Fully Redundant 3 Call Centers, 7/24/365 Operation Clinical Research Experienced Staff RNs, Certified Cardiac Technicians Healthcare Professionals Research Experienced Project Managers Dedicated IT Professional 7 X Dedicated Staff Regulatory Affairs & Compliance Staff Regulatory & Compliance Officer Staff Legal Counsel & FDA Advisory HIPPA & 21 CFR Part 11 Compliant JCAHO & CCHIT Certified Independently Audited Regulatory knowledge & Experience Information Systems & Operational Infrastructure Clinical Expertise Physician & Scientific Advisory

3 Lifewatch Research Services In – Clinic Arrhythmia Monitoring System Continuous Arrhythmia Monitoring

4 LifeStar AF Express Auto-Detect Captures/records asymptomatic and symptomatic events: Atrial Fibrillation, Tachycardia, Bradycardia Syncope Records symptomatic events: Physically or mentally challenged patients Sleeping patients Children Those with infrequent symptoms

5 LifeWatch Research Services Web eSuite eReport: online report retrieval, printing & management eInform: Physician/patient enrollment forms, multi-language educational materials ePrescribe: Online Patient Enrollment eDirect remote access Easy to setup, use and manage exchange of data Online supplies ordering HIPAA & 21 CFR Part 11 Compliant

6 LifeWatch Research Services - Partners / Project Sponsors Medical Device Manufacturers Contract Research Organizations Pharmaceutical / BioTech Developers Academic Research Organizations

7 Training Agenda – Arrhythmia Monitoring for: GSK - PLK The Subject Monitoring Process Monitoring Kit ECG Receiving / Uploading Station Shipping/Inventory Subject Enrollment The LifeStar AFX Recording Device Subject Preparation & Hook Up Recording & Sending a Baseline ECG transmission Auto-Recording & Uploading, Viewing & Sending Subject Reports Trouble Shooting and Support

8 Monitoring Kit Kit Contents Return packaging with prepaid label Blue bag containing: LifeStar AF Express device Language appropriate manual Extra sets of batteries / Electrodes

9 ECG Receiving Stations & Printer Two Laptops / One Printer – One Operational – One Backup Requires Internet connection to connect to LifeWatch Research Services

10 Enrollment and Baseline Transmission The site coordinator will call the toll free number and: Enroll the subject with LifeWatch Data Systems Assist the subject with device hook up, recording an ECG & sending his/her initial baseline ECG to LifeWatch services Please have the following information available: Site & Subjects ID Number Subjects date of birth Device Serial Number GSK Defined Demographic Data

11 Enrollment Form: The site coordinator will complete the designated subject enrollment form and fax into LifeWatch Research Services

12 LifeStar AF Express Cardiac Monitor (AFX) The LifeStar AF Express cardiac event monitor is a loop memory, single- channel ECG recording device. The LifeStar AF Express stores up to 10 minutes of real time ECG.

13 The LifeStar AF Express Cardiac Event Monitor

14 Steps to Subject Hook Up Connecting the Device Insert 2 AAA batteries into battery compartment Place the electrodes on the chest referring to the diagram provided Plug the lead set into the top of the device After a brief pause, the device will beep twice to indicate that scanning has begun.

15 Steps For Optimal Impedance Prepare the skin Remove any lotion, oil, powder or other substances from the skin Abrade the skin where the electrodes will be placed If the patient has a hairy chest it may be necessary to shave the areas where the electrodes will be placed

16 Create A Manual ECG Recording The Baseline Press the Record button to save an event The device will beep twice after each event

17 Automatic event recording The device may be programmed to automatically store a heart rhythm If the auto recorded event alert is programmed on, an alarm will sound when the device automatically records an event. If this occurs, the user should transmit the event as soon as possible

18 Transmitting an ECG Recording Place the device close to microphone attached to the laptop Press the SEND button (located on the back of the monitor) until an audible tone is heard, then release the button. The monitor emits a fluctuating tone; at the end of the transmission, the tone will stop

19 Sending, Storing, Viewing Subject ECG Reports Glaxo: Patient data will be downloaded to Laptop and TTMs will be transmitted to LW.

20 Erasing Sent ECG Recordings There is no need to erase sent recordings. Once the recording is transmitted to LifeWatch in its entirety, the device is automatically ready to receive new recordings as soon as the lead wire is plugged in again.

21 Transmission Processing at LifeWatch research Services

22 Using Online Enrollment and Reporting Viewing

23 eReport Features & Benefits Efficient online enrollment, report viewing, editing, retrieval, and patient educational materials Remote Access - Easy to setup, use and manage Electronic filing - view, print and transfer files Immediate enrollment into LifeWatch system Download physician and patient enrollment forms, multi- language educational materials for patients Paperless Process - Save precious resources Reduce workload for staff through efficient data flow management Eliminate fax problems and high cost of toner HIPAA Complaint and 21 CFR part 11Compliant

24 Logging on to LifeWatch eReport 1.Go to 2.Click Login

25 LifeWatch eReport – User Name & Password 4.In the pop-up window, enter your user name and password provided by LifeWatch New eReport Users are asked to change their password when they first login 5.You are now in the eReport web site, and may begin to enroll patients, manage inventories and view patient reports.

26 Subject Enrollment: via.Web

27 Posting Reports to the Web

28 Sample Report

29 Trouble Shooting – LifeWatch Support 7 X 24 X 365 Support Toll free Access to Immediate Clinical & Technical Support On-Line System Support with Live System IT Connection WebX Training for new Clinicians or refresher training Rapid Turn Around Time (TAT) on all ECG Transmissions – Cardiologist & EP Support When Necessary Dr. Hemali Shah Director, Research Services (224) – Cellular (847) – Office Direct

30 Thank you for your attention!

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