Presentation on theme: "LifeWatch Research Services Arrhythmia Monitoring Overview"— Presentation transcript:
1 LifeWatch Research Services Arrhythmia Monitoring Overview
2 LifeWatch Research Services – Business Model LifeWatch Information SystemsState of the Art Telecomm and IS NetworkScaleable, High Volume, Fully Redundant3 Call Centers, 7/24/365 OperationRegulatory Affairs & ComplianceStaff Regulatory & Compliance OfficerStaff Legal Counsel & FDA AdvisoryHIPPA & 21 CFR Part 11 CompliantJCAHO & CCHIT CertifiedIndependently AuditedRegulatory knowledge& ExperienceInformation Systems & Operational InfrastructurePhysician & Scientific AdvisoryClinical ExpertiseClinical Research Experienced StaffRNs, Certified Cardiac TechniciansHealthcare ProfessionalsResearch Experienced Project ManagersDedicated IT Professional7 X Dedicated StaffPhysician & Advisory BoardStaff Board Certified CardiologistsElectrophysiologists
3 Lifewatch Research Services In – Clinic Arrhythmia Monitoring SystemContinuous Arrhythmia Monitoring
4 LifeStar AF Express Auto-Detect Captures/records asymptomatic and symptomatic events:Atrial Fibrillation, Tachycardia, BradycardiaSyncopeRecords symptomatic events:Physically or mentally challenged patientsSleeping patientsChildrenThose with infrequent symptoms
5 LifeWatch Research Services Web eSuite eReport:online report retrieval, printing & managementeInform:Physician/patient enrollment forms, multi-language educational materialsePrescribe:Online Patient EnrollmenteDirect remote accessEasy to setup, use and manage exchange of dataOnline supplies orderingHIPAA & 21 CFR Part 11 Compliant
6 LifeWatch Research Services - Partners / Project Sponsors Medical Device ManufacturersContract Research OrganizationsPharmaceutical / BioTech DevelopersAcademic Research Organizations
7 Training Agenda – Arrhythmia Monitoring for: GSK - PLK107427 The Subject Monitoring ProcessMonitoring KitECG Receiving / Uploading StationShipping/InventorySubject EnrollmentThe LifeStar AFX Recording DeviceSubject Preparation & Hook UpRecording & Sending a Baseline ECG transmissionAuto-Recording & Uploading, Viewing & SendingSubject ReportsTrouble Shooting and Support
8 Monitoring Kit Kit Contents Return packaging with prepaid label Blue bag containing:LifeStar AF Express deviceLanguage appropriate manualExtra sets of batteries / Electrodes
9 ECG Receiving Stations & Printer Two Laptops / One Printer – One Operational – One BackupRequires 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 SystemsAssist the subject with device hook up, recording an ECG & sending his/her initial baseline ECG to LifeWatch servicesPlease have the following information available:Site & Subject’s ID NumberSubject’s date of birthDevice Serial NumberGSK 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.
14 Steps to Subject Hook Up Connecting the DeviceInsert 2 AAA batteries into battery compartmentPlace the electrodes on the chest referring to the diagram providedPlug the lead set into the top of the deviceAfter a brief pause, the device will beep twice to indicate that scanning has begun.
15 Steps For Optimal Impedance Prepare the skinRemove any lotion, oil, powder or other substances from the skinAbrade the skin where the electrodes will be placedIf 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 eventThe device will beep twice after each event
17 Automatic event recording The device may be programmed to automatically store a heart rhythmIf 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 laptopPress 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
23 eReport Features & Benefits Efficient online enrollment, report viewing, editing, retrieval, and patient educational materialsRemote Access - Easy to setup, use and manageElectronic filing - view, print and transfer filesImmediate enrollment into LifeWatch systemDownload physician and patient enrollment forms, multi-language educational materials for patientsPaperless Process - Save precious resourcesReduce workload for staff through efficient data flow managementEliminate fax problems and high cost of tonerHIPAA Complaint and 21 CFR part 11Compliant
24 Logging on to LifeWatch eReport Go toClick Login
25 LifeWatch eReport – User Name & Password In the pop-up window, enter your user name and password provided by LifeWatchNew eReport Users are asked to change their password when they first loginYou are now in the eReport web site, and may begin to enroll patients, manage inventories and view patient reports.
29 Trouble Shooting – LifeWatch Support 7 X 24 X 365 SupportToll free Access to Immediate Clinical & Technical SupportOn-Line System Support with Live System IT ConnectionWebX Training for new Clinicians or refresher trainingRapid Turn Around Time (TAT) on all ECG Transmissions – Cardiologist & EP Support When NecessaryDr. Hemali ShahDirector, Research Services(224) – Cellular(847) – Office Direct
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