La piattaforma PillCam® e il RAPID® 5 edited

La piattaforma PillCam * * Pending FDA clearance

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

DataRecorder 2 LED della capsula LED DataRecorder Interruttore Connettore per albero sensori Comparto della batteria Connettore per la batteria e porta USB Auto shut-off after 15 minutes of inactivity. To Power on hold SW for 1 sec / Power off hold for 5 sec. Audible beep every 5 mins when battery is below 10%; also 25% LED will blink LED della batteria

Applicazione dell’albero sensori al paziente

Continuous Innovation RAPID Software Capabilities 2001 RAPID 1.3 2002 RAPID 1.4 2003 RAPID 2 2004 RAPID 3 2005 RAPID 4.0 2006 RAPID 4.1 2007 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)

Il RAPID 5 supporta tutte le capsule PillCam PillCam ESO 2 PillCam SB 2 PillCam COLON All RAPID versions ≥RAPID 5.1

Campo di visione più ampio Nuova forma dell’immagine 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. Traditional Round Image previous RAPID versions New Image Shape – RAPID 5 11% more viewable mucosa per image All videos complied in RAPID 5 will display the new image shape. This new image shape is optimized to display the images from the new PillCam capsules with 11% more viewable mucosal area due to image shape alone. Videos compiled in older versions of RAPID are viewable with RAPID 5 but will display with the original round image.

Caratteristiche del RAPID® 5.2 Study Manager QuickView v5 Impostazioni: High/Normal/Low Image Adjustment in un click A–Mode o M-mode (se M-mode attivo) 1) M-mode enabling in settings controls the creation mode of the video – A-mode alone or A-mode / M-Mode. 2) When opening the RAPID 5.2 screen all buttons, including A-mode / M-Mode appear grayed out. 3) When a video is loaded, A-mode / M-Mode display is according to what video streams are supplied. If created as A-Mode only, the M-Mode button will not display. 4) When video is closed, A-mode / M-Mode button display is according to the last video viewed until a new video is loaded. Score di Lewis 10

A-mode or M-mode as Diagnostic Viewing Modes Automatic Viewing Mode (A-mode) alone is the default viewing mode for RAPID 5. 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 The Market pushed back / Given responded

Il QuickView non sostituisce la visione dellíntero filmato La funzione QuickView consente una preview veloce del filmato SB, evidenziando immagini di potenziale interesse all’interno del video. 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 Another very helpful feature is QuickView, which allows you to preview a case before you read the full video to get an idea of what you will find. [Describe QuickView per the key messages]. An independent study of 50 cases was reported by MUSC at this year’s DDW, and they found a 100% correlation between the findings on QuickView and the final diagnosis after a full review of each case. That might save you some reading time on occasion and certainly help to point out some possible abnormalities to look for in the video. QuickView is another unique feature that represents our leadership in capsule endoscopy. Il QuickView non sostituisce la visione dellíntero filmato

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 Enhance image sharpness with a single click that applies advanced, proprietary image processing technology for a vivid image during RAPID video review. Support: The preset, one-click enhancement displays an image that is especially vivid while continuing to show subtle gradations between visual information. Additional functionality allows customization of Sharpness, Color, and Brightness. A Blue Image feature adjusts the display color contrast to render a bluish image that may assist in the diagnostic process.

Image Adjustment: pulsanti Quick Adjust Un click per applicare all’immagine le impostazioni salvate La freccia apre il menu a comparsa per impostazioni avanzate e blue mode Enhance image sharpness with a single click that applies advanced, proprietary image processing technology for a vivid image during RAPID video review. Support: The preset, one-click enhancement displays an image that is especially vivid while continuing to show subtle gradations between visual information. Additional functionality allows customization of Sharpness, Color, and Brightness. A Blue Image feature adjusts the display color contrast to render a bluish image that may assist in the diagnostic process.

One-Click “Quick Adjust” New Proprietary Technology to enhance sharpness and contrast Quick Adjust Applied Standard

Image Adjustment Sliders Original Brightness Enhance image sharpness with a single click that applies advanced, proprietary image processing technology for a vivid image during RAPID video review. Support: The preset, one-click enhancement displays an image that is especially vivid while continuing to show subtle gradations between visual information. Additional functionality allows customization of Sharpness, Color, and Brightness. A Blue Image feature adjusts the display color contrast to render a bluish image that may assist in the diagnostic process. Sharpness Brightness Color Color - Yellow Color - Red

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

Sezione Aiuto Sezione aiuto integrata nel programma: Training Informazioni Risorse stampabili

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

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

Lewis Score Utile per una generica valutazione del danno alla mucosa. Facilita la comunicazione e la standardizzazione Utile per verificare l’effetto delle terapie, soprattutto nelle malattie infiammatorie

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) 146-54

Parametri per il calcolo dello score Edemi villosi Ulcere Stenosi Aliment. Pharmacol.Ther. 2008;Jan 15; 22(2) 146-54

Villous Appearance Short segment ≤ 10% of the tertile Long segment 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 Single one isolated area Patchy normal intervening mucosa Diffuse within the affected segment Aliment. Pharmacol.Ther. 2008;Jan 15; 22(2) 146-54

Ulcers Short segment ≤ 10% of the tertile Long segment 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 Single 1 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 < ¼ ¼ - ½ > ½

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

Calculation of Score is Automatically Performed in the Software Highest Tertile Score + Study Stenosis Score = Final Score Aliment. Pharmacol.Ther. 2008;Jan 15; 22(2) 146-54

Preliminary Cutoff Values for Lewis Score A score less than 135 is normal or clinically insignificant mucosal inflammatory change A score between 135-790 is mild A score >790 is Moderate to severe Scoring thresholds for the diagnosis of SB Crohn’s 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) 146-54

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’.

Attivo dopo l’ndividuazione dei punti di riferimento SB Reference images in Atlas ➙ Attivo dopo l’ndividuazione 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 l’intero intestino tenue

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

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

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” Centralizes and simplifies file management functions to allow the user to conveniently find, open, organize and export entire RAPID studies and individual files. New customers will find the study manager can function as a kind of “home page” for many actions they wish to perform. Legacy users still have the traditional Open video options from the File menu. Accessed via a new button in the upper left corner of the RAPID main screen, the Study Manager displays a Searchable detailed listing of all studies in an available “archive” or study location.

Study Manager Ricerca avanzata Ricerca gli esami per dati paziente e altri dati dell’esame Esami offline Mostra i dati degli esami offline per facilitarne il reperimento nei DVD Funzionalità di esportazione avanzate Semplicità di masterizzazione su CD e DVD Copia in altre ubicazioni Possibilità compressione di interi esami Centralizes and simplifies file management functions to allow the user to conveniently find, open, organize and export entire RAPID studies and individual files. New customers will find the study manager can function as a kind of “home page” for many actions they wish to perform. Legacy users still have the traditional Open video options from the File menu. Accessed via a new button in the upper left corner of the RAPID main screen, the Study Manager displays a Searchable detailed listing of all studies in an available “archive” or study location.

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 Direct from DataRecorder First copy data from DR then create video

Export Functions in Study Manager

Export Functions

Tools Setting to Select Manual Mode Option

Tools Setting to Select Report Format

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

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

Clear MD name between videos

La schermata del referto Image Adjustment “Componi & Esporta” Cattura delle immagini direttamente da questa schermata

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

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

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

Compatibility RAPID Access and RAPID Reader Vista (≥SP1) RAPID Access and RAPID Reader Not compatible with studies compiled with RAPID 3 or earlier RAPID versions AMD Processors AMD Athlon™ 64 X2 - 2.6 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.

SB Video Creation Times (approximate times for 8 hour SB videos *) WS Type Quick Release Compile Download 360 35 min 2 hr, 10 min 370 1 hr, 40 min 380 <<35 min 56 min 390 Dual 39 min 390 Quad ≤ 35 min 25 min <35 min T3400 ≤33 min 33 min The number of cores used by the operating system and by RAPID may affect compilation time and maximum viewing speed. DELL 390 Quad or T3400 with WIN XP utilize cores as below: RAPID 5.2 – all four cores RAPID 5.1 – three cores only DELL 390 Quad with WIN 2000 operates as Dual Core *Compilation times for SB2 capsules are somewhat shorter than for SB capsules **Quick Release and Download times are shorter then previous values due to the introduction of DR2 v168 SW version ***Compilation times are shorter for Quad core machines with RAPID 5.2. *Compilation times for SB2 capsules are somewhat shorter than for SB capsules

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

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.

Registration Procedure 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.

RAPID RT

Benefici del RAPID RT Ausilio durante l’esame con l’RT: la PillCam COLON richiede la verifica del transito della capsula nell’intestino tenue; nell’esame con PillCam SB, l’RT 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 l’immissione 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

RAPID Reader 5 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 5 Access

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

Enabling Network Functionality Patient Check-in Information PillCam Report Export Data RAPID Networking support: input patient data from predefiined location; export report data to [predefined location Formats are predefined for Check-in info and Export Data Source/Destination locations are set in RAPID

RAPID 5 Access Terminologia tecnica 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 all’interno di strutture mediche. EMR – Electronic Medical Record

RAPID 5 Access Terminologia tecnica 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

Check-In Origin Location Patient Data Import Location

Report Data Export Destination Location EMR Report Data export location

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

Report Data Export

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

Sicurezza con RAPID Access Gira su computer Windows della struttura aziendale e ALL’INTERNO 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. “primarily:” – because of the additional group privilege tool in 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

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