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CONFIDENTIAL La piattaforma PillCam ® e il RAPID ® 5.

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Presentazione sul tema: "CONFIDENTIAL La piattaforma PillCam ® e il RAPID ® 5."— Transcript della presentazione:

1 CONFIDENTIAL La piattaforma PillCam ® e il RAPID ® 5

2 -DRAFT- La piattaforma PillCam * Pending FDA clearance *

3 -DRAFT- Albero a 8 sensori (SB e COLON) Albero a 3 sensori (ESO) Albero sensori & DataRecorder Albero sensori collegato al DataRecorder nellalloggia- mento per download dei dati e ricarica batteria

4 -DRAFT- DataRecorder 2 LED della capsula Connettore per albero sensori Interruttore Connettore per la batteria e porta USB LED della batteria LED DataRecorder Comparto della batteria

5 -DRAFT- Applicazione dellalbero sensori al paziente

6 -DRAFT-

7 Continuous Innovation RAPID Software Capabilities 2001 RAPID RAPID RAPID RAPID RAPID RAPID RAPID 5 Automatic Viewing Mode Variable Viewing Speed Localization Suspected Blood Indicator (SBI) Standard Reporting Image Zoom Capability HIPAA Deidentification HIPAA Security, CFR 21 Part 11 My GI Dictionary Tissue Color Bar PillCam ESO Capability Full Screen Video Display Password Support Thumbnail Markings DoubleView QuadView QuickView V3 V4 V5 RAPID Atlas + V2 Circumference Scale New Image Shape – Increased Angle of View Image Adjustment Lewis Score Improved Standard Viewing (A-Mode) to reduce viewing time PillCam COLON Capability Mis: Compress, Zip, easy CD burn, edit-check-in, export atlas image Study Management Network Connectivity (In RAPID 5.2 Access)

8 -DRAFT- Il RAPID 5 supporta tutte le capsule PillCam PillCam ESO 2 PillCam SB 2 PillCam COLON All RAPID versions RAPID 5.2 RAPID 5.1

9 -DRAFT- Optimized display for new PillCam capsules with more viewable mucosal area Displayed when video is compiled with RAPID 5. Videos compiled with earlier RAPID versions display as Round Images. Campo di visione più ampio Nuova forma dellimmagine Traditional Round Image previous RAPID versions New Image Shape – RAPID 5 11% more viewable mucosa per image

10 -DRAFT- Caratteristiche del RAPID ® 5.2 QuickView v5 Impostazioni: High/Normal/Low Image Adjustment in un click Score di Lewis Study Manager A–Mode o M- mode (se M-mode attivo)

11 -DRAFT- A-mode or M-mode as Diagnostic Viewing Modes A-mode Features: Smoothes diagnostic video review for increased reading efficiency Combines repetitive images, allowing focus on images that show change Is validated as equivalent to Manual Viewing Mode in a study using 1,800 small bowel pathology images M-mode is also available as an optional mode selectable by the user in RAPID Settings Automatic Viewing Mode (A-mode) alone is the default viewing mode for RAPID 5.

12 -DRAFT- QuickView DDW 2007 Video Capsule Endoscopy: Accuracy of QuickView (ID# W1246) Appalaneni, et al 50 prospective patients Avg. QV read time: 3 minutes There was no significant difference in the findings when comparing standard view to QV alone while interpreting SB images Il QuickView non sostituisce la visione dellíntero filmato La funzione QuickView consente una preview veloce del filmato SB, evidenziando immagini di potenziale interesse allinterno del video.

13 -DRAFT- Image Adjustment Allows customization of image appearance to enhance visualization. –Quick Adjust uses a new proprietary technology to display an image with enhanced sharpness and contrast via a single click. –Sharpness, Color, and Brightness can be customized to user preferences. –A Blue Image feature adjusts the display color contrast to render a bluish image that may assist in the diagnostic process. Works for videos created with any RAPID software version

14 -DRAFT- Image Adjustment: pulsanti Quick Adjust Un click per applicare allimmagine le impostazioni salvate La freccia apre il menu a comparsa per impostazioni avanzate e blue mode

15 -DRAFT- One-Click Quick Adjust New Proprietary Technology to enhance sharpness and contrast Standard Quick Adjust Applied

16 -DRAFT- Image Adjustment Sliders Sharpness Brightness Color Original Brightness Color - Yellow Color - Red

17 -DRAFT- Blue Image Amplifies color contrast to render bluish image May aid diagnostic process

18 -DRAFT- Sezione Aiuto Sezione aiuto integrata nel programma: Training Informazioni Risorse stampabili

19 -DRAFT- Opened via F1 or from Help Printable one-page guides Printable Procedure Log (U.S.)

20 -DRAFT- PillCam COLON Regimen documents Help Center 3. Information for Physician 2. Information for Medical staff 1. Patient Instructions (5 languages)

21 -DRAFT- Lewis Score Utile per una generica valutazione del danno alla mucosa. Facilita la comunicazione e la standardizzazione Utile per verificare leffetto delle terapie, soprattutto nelle malattie infiammatorie

22 -DRAFT- Developing the Lewis Score A scoring index was developed and tested by a working group of the thought leaders in capsule endoscopy Endoscopic variables were initially evaluated prospectively (erythema, edema, nodularity, villous appearance, denuded mucosa, ulceration, stenosis) The index was prospectively tested in a blinded fashion with 44 de-identified full length videos with CD (n=22), NSAID enteropathy (n=12), Unknown (n=10) All studies were assessed for perceived global severity –No disease or clinically insignificant –Mild disease –Moderate to severe disease Aliment. Pharmacol.Ther. 2008;Jan 15; 22(2)

23 -DRAFT- Parametri per il calcolo dello score Edemi villosi Ulcere Stenosi Aliment. Pharmacol.Ther. 2008;Jan 15; 22(2)

24 -DRAFT- Villous Appearance Normal or Edematous Distribution –Short segment 10% of the tertile –Long segment 11 to 50% of the tertile –Whole tertile > 50% of the tertile Descriptors –Singleone isolated area –Patchynormal intervening mucosa –Diffusewithin the affected segment Aliment. Pharmacol.Ther. 2008;Jan 15; 22(2)

25 -DRAFT- Ulcers Ulcers are characterized by white or yellow base, red collar Distribution –Short segment 10% of the tertile –Long segment 11 to 50% of the tertile –Whole tertile > 50% of the tertile Number –Single1 –Few 2-7 –Multiple 8 or More Size - is determined by how much of the capsule picture is filled by the ulcer (circumference). Score the largest ulcer in the tertile ½

26 -DRAFT- Stenosis Number Ulcerated or not ulcerated Traversed or not traversed ( did the capsule pass through the narrowed lumen?)

27 -DRAFT- Final Score Highest Tertile Score + Study Stenosis Score = Calculation of Score is Automatically Performed in the Software Aliment. Pharmacol.Ther. 2008;Jan 15; 22(2)

28 -DRAFT- Preliminary Cutoff Values for Lewis Score A score less than 135 is normal or clinically insignificant mucosal inflammatory change A score between is mild A score >790 is Moderate to severe Scoring thresholds for the diagnosis of SB Crohns disease and discriminative abilities of the scoring index also requires further testing and validation The score does not differentiate disease, it only illustrates the damage a disease does to the SB mucosa Repeat capsules to monitor mucosal healing should go through a prior-authorization process (in the USA) to document the medical necessity for the second exam Aliment. Pharmacol.Ther. 2008;Jan 15; 22(2)

29 -DRAFT- Usare il Lewis Score Esaminare il filmato come sempre, segnando i punti di riferimento e Creando le miniature. La prima immagine duodenale e cecale devono essere individuate. Fare click sul pulsante Lewis score.

30 -DRAFT- Attivo dopo lndividuazione dei punti di riferimento SB SB suddiviso in terzi uguali: Tertiles i peggiori dati relativi a Villi & Ulcere vengono inseriti per Tertile Le stenosi vengono indicate per lintero intestino tenue Reference images in Atlas

31 -DRAFT- Atlante arricchito Più di 400 immagini di tutti i tipi di capsula e dello score di Lewis

32 -DRAFT- Circumference Scale A tool for assessing circumferential involvement of a finding May be useful for estimating the size of esophageal varices or small bowel ulcers Circumference Scale

33 -DRAFT- Study Manager Gestione semplice e centralizzata degli esami eseguiti per consentire una rapida ricerca, apertura organizzazione ed esportazione di interi esami e singoli file. Una sorta di home page

34 -DRAFT- Study Manager Funzionalità di esportazione avanzate Semplicità di masterizzazione su CD e DVD Copia in altre ubicazioni Possibilità compressione di interi esami Esami offline Mostra i dati degli esami offline per facilitarne il reperimento nei DVD Ricerca avanzata Ricerca gli esami per dati paziente e altri dati dellesame

35 -DRAFT- Additional Workflow Enhancements Copy Raw Data with compression (5GB ~0.5GB) –Reduces the size of a raw data file for easier transfer to a computer with the full RAPID software. –Remote facilities using RAPID Reader can electronically deliver the raw data to a computer with full RAPID software for video creation. Multi-study raw data handling –Raw video data from several procedures can be saved to a single USB device Quick DataRecorder 2 Release –Allows faster re-use of the DataRecorder. The raw video data can be copied to the workstation in about 35 minutes, freeing the DataRecorder for the next patient. The video is compiled with full RAPID SW at a convenient later time. 2 Video Creation Options 1.Direct from DataRecorder 2.First copy data from DR then create video

36 -DRAFT- Export Functions in Study Manager

37 -DRAFT- Export Functions

38 -DRAFT- Tools Setting to Select Manual Mode Option

39 -DRAFT- Tools Setting to Select Report Format

40 -DRAFT- Smarter Report Management Reason for Referral shows in Report too RAPID 5 only Enter Reason for Referral at Check-In RAPID 5 only

41 -DRAFT- Update Patient Details Patient Details entered at Check-in can be updated after Video Creation

42 -DRAFT- Clear MD name between videos

43 -DRAFT- La schermata del referto Image Adjustment Cattura delle immagini direttamente da questa schermata Componi & Esporta

44 -DRAFT- Report Format Options PDF and MHT Format Options In R5.2 PDF = Default Korean and Chinese should be set to MHT. Report Types: Normal / Condensed (Normal = default)

45 -DRAFT- Sample Report- Normal Format Unlimited text in main fields. Images and comments appear starting on the second page.

46 -DRAFT- Sample Report- Condensed Format Enables one-page report with 4 images.

47 -DRAFT- Compatibility Vista (SP1) –RAPID Access and RAPID Reader –Not compatible with studies compiled with RAPID 3 or earlier RAPID versions AMD Processors –AMD Athlon 64 X GHz (in addition to Intel) Apple Mac Computers (e.g. IMAC, IBook) –With Boot Camp for running Windows DataRecorder Support –RAPID 5.2 supports DR1/DR1.5. (RAPID 5.2 Access / RAPID Reader do not) –RAPID 5.2 contains the DR 2 software update (168) for DR 2 / DR 2 C compatibility with PillCam ESO 2.

48 -DRAFT- SB Video Creation Times (approximate times for 8 hour SB videos *) WS TypeQuick ReleaseCompileDownload min2 hr, 10 min min1 hr, 40 min 380<<35 min56 min 390 Dual35 min39 min 390 Quad 35 min25 min<35 min T min25 min33 min *Compilation times for SB2 capsules are somewhat shorter than for SB capsules

49 -DRAFT- Setting Up Ensure no DR is connected during installation. New WS Desktop Background Graphic also available when RAPID Access / RAPID Reader installed Recommended especially for Wide Screens DR2

50 -DRAFT- Mandatory Registration Registration process for RAPID and RAPID Access To document end-user site data in order to manage product installation base and determine product support eligibility To enable proper allocation and utilization of Customer Support resources User is prompted to register after installation and can open RAPID 7 times unregistered before registration must be performed to open the software.

51 -DRAFT- Submit sales and customer data from distributor to Given / SAP 1 day prior to installation. GIVEN creates customer account or updates data in internal SAP DataBase. RAPID 5.2 installation disc is delivered with Serial Number. At customer site logon to registration portal or phone customer support with: Serial number (from media sleeve), System ID and System Key (displayed by RAPID system), Customer data (customer ID). If the customer is eligible for registration a registration key is generated and provided via portal or customer support. This registration key has to be entered into the provided registration screen. Data of each registrant will be linked with the GIVEN SAP DataBase. Registration Procedure

52 -DRAFT- RAPID RT

53 -DRAFT- Benefici del RAPID RT Ausilio durante lesame con lRT: –la PillCam COLON richiede la verifica del transito della capsula nellintestino tenue; –nellesame con PillCam SB, lRT può verificare se la capsula si è fermata nello stomaco, e quindi suggerire la somministrazione di procinetici; –RAPID RT può essere usato nelle urgenze per individuare sanguinamenti in stomaco o intestino; Funzionalità del RAPID Reader: –Possibile limmissione dei dati paziente lontano dalla macchina –Visione dei filmati in formato RAPID –Trasferimento dei dati grezzi contenuti nel Data Recorder per una successiva compilazione del video

54 -DRAFT- All RAPID 5.2 Access functions except video creation. Enables PillCam procedures to be performed away from the Given Workstation. Allows Patient Check-In / DR initialization Enables copying of raw video data from DR to USB device for later transfer to WS. Available as free download from the Given Website. No registration required. RAPID Reader 5

55 CONFIDENTIAL RAPID 5 Access

56 -DRAFT-

57 Consente limportazione di dati paziente dal sistema informatico dellospedale o del reparto. Consente lesportazione di referti e immagini delle procedure verso sistemi dellospedale o del reparto. Consente luso di risorse della rete dellospedale (come spazio su disco o periferiche) con RAPID Supporta vari modelli di organizzazione del lavoro per meglio adeguarsi alle esigenze della struttura. RAPID 5 Access Può essere installato su qualsiasi PC e supporta la videoendoscopia in un ambiente di rete

58 -DRAFT- Enabling Network Functionality Formats are predefined for Check-in info and Export Data Source/Destination locations are set in RAPID Patient Check-in Information PillCam Report Export Data

59 -DRAFT- Connettività – descrive ogni tipo di strumento di trasferimento di dati, comprese le interfacce e le reti (network). Network (Networking) – collegamento di più computer per la condivisione di risorse quali dischi, stampanti, etc. Interfaccia – collegamento fra due software per lo scambio di informazioni (può essere uni o bidirezionale). HL7 – speciale protocollo di interfaccia usato nel settore medico per la creazione di interfacce fra sistemi informatici medici. MIS (HIS) – termine generico per Medical Information System, può includere qualsiasi tipo di informazione elettronica usata allinterno di strutture mediche. EMR – Electronic Medical Record RAPID 5 Access Terminologia tecnica

60 -DRAFT- Formati e tipi di file PDF – New format for CE reports supported by RAPID 5 and most MIS MHT – Old format for CE report, opens with Internet Explorer, not supported by MIS XML – File format (type) supported by RAPID 5 Access to send and receive data to and from the MIS, i.e. patient information for check-in or CE Reports RAPID 5 Access Terminologia tecnica

61 -DRAFT- Check-In Origin Location Patient Data Import Location

62 -DRAFT- Report Data Export Destination Location EMR Report Data export location

63 -DRAFT- Check-In With EMR Data EMR Patient Data Import

64 -DRAFT- Report Data Export

65 -DRAFT- SOPRATTUTTO…… Un ulteriore vantaggio su tutta la Concorrenza EVENTUALMENTE DA INSERIRE COME ESCLUSIVA in eventuali capitolati.

66 -DRAFT- Sicurezza con RAPID Access Do not disseminate. The proposed changes to the PillCam Platform and the RAPID Application software have not received regulatory clearance and are not available for commercial distribution Gira su computer Windows della struttura aziendale e ALLINTERNO della rete aziendale sicura. RAPID funziona con le stesse caratteristiche di sicurezza del sistema informatico della struttura (autenticazione, accesso ai file) Accesso alle piattaforme di rete della struttura, salvataggio dei file (sicurezza, privacy) controllato dalla rete. RAPID Access usa driver certificati Microsoft per il collegamento ai registratori. RAPID Access cripta tutti i dati paziente inviati alla rete interna.

67 -DRAFT- Resources on RAPID 5.2 / RAPID 5 Access RAPID 5 Access IT Setup Guide RAPID 5.2 manual Global Launch Package-Platform-RAPID 5 - Updated Key Marketing Messages - Updated Marketing Release MR-49


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