1. LifeWatch Research Services Arrhythmia Monitoring Overview

2. LifeWatch Research Services – Business Model
LifeWatch Information Systems
State of the Art Telecomm and IS Network
Scaleable, High Volume, Fully Redundant
3 Call Centers, 7/24/365 Operation
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
Physician & Scientific Advisory
Clinical Expertise
Clinical Research Experienced Staff
RNs, Certified Cardiac Technicians
Healthcare Professionals
Research Experienced Project Managers
Dedicated IT Professional
7 X Dedicated Staff
Physician & Advisory Board
Staff Board Certified Cardiologists
Electrophysiologists

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 - PLK107427
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 & Subject’s ID Number
Subject’s 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
Go to
Click Login

25. LifeWatch eReport – User Name & Password
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
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!