Given Imaging GIVENIMAGING User Manual

Given Imaging Limited

User Manual

Given® Diagnostic Imaging SystemUser’s ManualDRAFT
Given® Diagnostic Imaging System User’s ManualGiven Imaging Ltd.COPYRIGHTThis manual is the property of Given® Imaging Limited. and may not be transferred or reproduced in any form withoutthe written permission of Given® Imaging Limited. This manual is protected under the copyright laws of Israel.Copyright © 2001, Given® Imaging Limited. All rights reserved.TRADEMARKSThe RAPID™ Application and the M2A™ Capsule are trademarks of Given® Imaging Limited. Given® is aregistered trademark of Given® Imaging Limited.MS Windows is a registered trademark of Microsoft Corporation.WARRANTYGiven® Imaging Limited warrants that the components of the Given® Diagnostic Imaging System have beendesigned, manufactured, packaged and tested with reasonable care and is free from any type of defects. Given®Imaging Limited is not liable for any incidental or consequential loss, damage, or expense arising , directly orindirectly , from the use of the Given® Diagnostic Imaging System. Given® Imaging Limited obligation as implied inthis warranty, is to repair or replace any component of the system. Customers are liable for all matters beyond Given®Imaging Limited control such as handling, storage, cleaning, misuse, treatment and diagnosis. This warranty is in lieuof and excludes all other warranties whether expressed or implied warranties of merchantabilty or fitness.FCC ID#=O8PGIVENIMAGINGThis device complies with Part 15 of the FCC rules. Operation is subject to the followingtwo conditions: (1) this device may not cause harmful interference, and (2) this devicemust accept any interference received, including interference that may cause undesiredoperation.Note:Changes or modifications not expressly approved by Given®Imaging Limited could void authority to operate the Given®Imaging Diagnostic System.US Federal Law restricts this device to sale by or on the order of a physician
Table of ContentsGiven Imaging Ltd.Table of ContentsCHAPTER ONE............................................................................................... 1GIVEN® DIAGNOSTIC IMAGING SYSTEM...................................................... 1System Overview........................................................................................ 1M2A™ Capsule...................................................................................... 3Data Recorder Set................................................................................... 5Data Recorder..................................................................................... 5Sensor Array....................................................................................... 6Battery Pack ....................................................................................... 6Waist Belt........................................................................................... 6Battery Charger .................................................................................. 6RAPID™ Application Software and Workstaion .................................. 8Indications and Contraindications .............................................................. 9Indications .............................................................................................. 9Contraindications.................................................................................... 9Warnings................................................................................................... 10Warnings........................................................................................... 10Precautions ............................................................................................... 12Precautions ....................................................................................... 12Adverse Events......................................................................................... 13System Labeling....................................................................................... 14System Specifications............................................................................... 15M2A™ Capsule.................................................................................... 15Data Recorder....................................................................................... 16RAPID™ Application Software........................................................... 16About this Manual.................................................................................... 17Conventions.......................................................................................... 18Contacting Given® Imaging..................................................................... 19CHAPTER TWO............................................................................................ 20SYSTEM SETUP............................................................................................. 20Before Your System Arrives .................................................................... 20Connecting the System............................................................................. 21Items to Connect................................................................................... 21Connecting the Workstation................................................................. 22Connecting the Connection Box........................................................... 25System Setup Scheme....................................................................... 27
ContentsGiven Imaging Ltd.CHAPTER THREE........................................................................................ 28GETTING TO KNOW RAPID™.................................................................... 28Running the RAPID™ Application.......................................................... 28Selecting a Language............................................................................ 29Changing Display Settings ................................................................... 30Changing the Units............................................................................... 32Main Screen.............................................................................................. 33Title Bar................................................................................................ 35Main Screen Menus.............................................................................. 35File Menu.......................................................................................... 36Video Menu...................................................................................... 37Online Menu..................................................................................... 38Tools................................................................................................. 38Video Section ....................................................................................... 39Thumbnail Section................................................................................ 39Timebar Section.................................................................................... 39Patient Check-In....................................................................................... 41Creating a Movie ...................................................................................... 46Creating a PRR Movie.......................................................................... 46Defining Directories......................................................................... 46Connecting the Recorder and Downloading..................................... 48PRR Movie Name............................................................................. 50Selecting an Existing Movie................................................................. 50Guidelines for Watching the Movie ..................................................... 51Watching the PRR Movie..................................................................... 52Primary Screening of the Movie....................................................... 52Selecting the PRR Movie Speed....................................................... 54Setting the Fast and Slow Speed Rate.............................................. 54Restarting the Movie ........................................................................ 56Moving by Frames............................................................................ 56Moving by Time Indication.............................................................. 57Playing and Pausing.......................................................................... 58Capturing an Image .......................................................................... 59Thumbnail Section.................................................................................... 60Selecting a Thumbnail...................................................................... 61Scrolling through the Thumbnails.................................................... 62Saving a Thumbnail.......................................................................... 63
ContentsGiven Imaging Ltd.Saving a Group of Thumbnails......................................................... 64Removing a Thumbnail.................................................................... 65Creating or Editing a Comment........................................................ 65Reading the Comment...................................................................... 66Moving from a Thumbnail to the Movie.......................................... 67Timebar..................................................................................................... 68Scrolling Through the Movie ............................................................... 69Moving from Comment Indication to Frame ....................................... 69CHAPTER FOUR .......................................................................................... 70PERFORMING CAPSULE ENDOSCOPY.......................................................... 70Preparing the Patient ............................................................................ 71Preparing Patient Examination Set....................................................... 73Checking In a Patient ........................................................................... 73Deploying the Data Recorder Set......................................................... 74Adjusting the Recorder Battery Belt ................................................ 75Connecting Belt Components........................................................... 76Attaching the Sensor Array to the Patient........................................ 78Putting the Belt on the Patient.......................................................... 82Dispensing the M2A™ Capsule ........................................................... 84Discharging the Patient ........................................................................ 86Receiving the Examination Set............................................................. 87Charging the Battery Pack................................................................ 88Troubleshooting........................................................................................ 91Electrical Outage .................................................................................. 91Data Recorder....................................................................................... 92Recorder Initialization ...................................................................... 92Data Recorder Operation.................................................................. 93Data Recorder Download................................................................. 99Sensor Array....................................................................................... 100Sensor Array Condition.................................................................. 100Sensor Location.............................................................................. 100M2A™ Capsule.................................................................................. 101INDEX.......................................................................................................... 103
ContentsGiven Imaging Ltd.
Given Imaging Ltd. 1Chapter OneGiven® Diagnostic ImagingSystemSystem OverviewSystem OverviewSystem OverviewSystem OverviewThe Given® Diagnostic Imaging System is an easy-to-usenon-invasive and ambulatory device that permitsvisualization of the patient’s gastrointestinal tract, especiallythe small intestine.The system is comprised of three main components:• M2A™ Capsule• Data Recorder Set• RAPID™ Application Software and Workstation
OverviewGiven Imaging Ltd. 2The M2A™ Capsule acquires pictures of the gastrointestinaltract and transmits them to the Data Recorder. The DataRecorder stores the pictures and downloads the data to theRAPID™ Workstation. On the workstation, the data isprocessed into a colorful, easy-to-control Patient RAPID™Report (PRR) video movie. You can view the PRR movie toanalyze and make diagnoses about any abnormalities in thegastrointestinal tract.Even though the Given® Diagnostic Imaging Systemperforms the complicated tasks of filming the digestiveactivity and image and other data processing, it is very easyto use, eliminating the need for sedation. Moreover, it doesnot require the patient to undergo an invasive anduncomfortable procedure, and assists in the early detectionof pathologies of the small bowel.RAPID™WorkstationDataRecorderSensor ArrayM2A™CapsuleWaist Belt
OverviewGiven Imaging Ltd. 3M2A™ CapsuleThe ingestible imaging M2A™ Capsule acquires videoimages while traveling along the patient’s gastrointestinaltract. The M2A™ Capsule is propelled by peristalsis throughthe gastrointestinal tract and does not require a pushing forceto propel it through the bowel.The M2A™ Capsule contains a miniscule color video camerawith a flash (CMOS Imager), a watch battery, a transmitter,and an antenna, all of which are embedded within a regularsize ingestible capsule. The Capsule is a two-dome, cylindershaped unit having an outer diameter of 11mm and length of26mm, and it is made out of biocompatible plastic.The M2A™ Capsule is provided ready for ingestion, storedin a blister, a hermetically sealed magnetic packaging. Theproximity of a magnet in the blister inactivates the M2A™Capsule.Each M2A™ Capsule comes with a holder that covers theCapsule’s imager and enables you to handle the M2A™Capsule until ingestion.M2A™CapsuleM2A™Capsule withholderM2A™Capsule withblister
OverviewGiven Imaging Ltd. 4The M2A™ Capsule starts immediately after its removalfrom the proximity of the magnet in the blister and theconsequent closing of the magnetic switch in the capsule.After a brief (less than one minute) test by the physician toverify that the capsule is active, the capsule is ingested by thepatient. While active, the capsule transmits images at a rate of2 images per second. For each image, an illuminating lightflash of 100ms is applied with the illuminating LEDs. Whenthe battery power is depleted, the transmitter disables theimager and switches the M2A™ Capsule off.For specification and technical parameters of the M2A™Capsule, refer to System Specifications on page 15. ForIndications and Contraindications, refer to Indications andContraindications on page 9.
OverviewGiven Imaging Ltd. 5Data Recorder SetThe Data Recorder Set includes the following items:• Data Recorder• Sensor Array• Battery Pack• Waist Belt• Battery ChargerData RecorderThe Data Recorder is an external receiving/recording unitthat receives the data transmitted by the M2A™ Capsule.The Data Recorder is a portable Walkman™-size battery-operated unit attached to a waist belt worn by the patientduring the examination.The Data Recorder is comprised of a receiver, processormodule and a hard disk drive for storing the data. All of thesecomponents are encased in a plastic (ABS) box.The Data Recorder is ready for operation once you connectthe Battery Pack and the Sensor Array to the Data Recorder.However, the actual recording requires that the input signalcross a threshold. A green blinking LED indicates whetherand when the Data Recorder records data.
OverviewGiven Imaging Ltd. 6Sensor ArrayThe Sensor Array receives data from the M2A™ Capsule andtransfers it to the Data Recorder. It is comprised of 8 identicalsensors. Each sensor is connected to the Data Recordermodule by a flexible coaxial cable. The sensor is built offlexible printed circuit board (PCB) and is attached to theskin by means of disposable, medical adhesive pads.Battery PackThe Battery Pack is the power supply of the Data Recorder. Itincludes 8 Nickel-metal 6V rechargeable batteries. TheBattery Pack is disconnected from the Data Recorder at theend of each examination and is connected to the Chargersupplied with the Given® Diagnostic Imaging System to beready for the next procedure.Waist BeltThe Waist Belt is an adjustable waist-belt that includes twopouches to hold the Data Recorder and the Battery Pack. Thebelt also includes a flap to hold the excess Battery Pack-DataRecorder cable. The Waist Belt also contains shielding thatfacilitates FCC compliance. The Waist Belt must thereforebe worn at all times while the M2A™ Capsule is activeinside the patient.Battery ChargerThe Battery Charger charges the Battery Pack and should beused after each examination.
OverviewGiven Imaging Ltd. 7For specification and technical parameters of the DataRecorder, refer to System Specifications on page 15.Sensor ArraySensor ArraycableData RecorderM2A™CapsuleM2A™CapsulewithholderBatteryPack
OverviewGiven Imaging Ltd. 8RAPID™ Application Software and WorkstaionThe RAPID™ Workstation is a modified standard personalcomputer designed for storage, presentation and processingof the acquired images and for generating reports.The RAPID™ (Reporting and Processing of Images andData) Application Software is a program installed on theWorkstation, which performs various tasks as the followingtable lists:Task ExplanationRecordercommunication Enables Recorder initialization and data downloadfrom the Recorder to the workstation.Data conversion Handles various data formats.Image processing Performs the image processing algorithm andcondenses up to 10 hours of filming into a 30 minutemovie.Video display Displays the Patient RAPID Report (PRR).Thumbnail display Enables copying individual images from the movie, todisplay, annotate, print and save them.AVI movie Creates a short movie of the selected image and itsadjacent images.Timebar display Shows the exact time of the current image displayed inthe Video section.Patient Check-In Enables etntry and storage of all patient information.Note:To use the RAPID™ Application, you should be familiar withMicrosoft Windows® interface and capable of using a mouse.
OverviewGiven Imaging Ltd. 9Indications and ContraindicationsIndications and ContraindicationsIndications and ContraindicationsIndications and ContraindicationsIndicationsThe Given® Diagnostic Imaging System is intended for thedetection of pathologies as an adjunctive tool in the diagnosisof small bowel gastrointestinal disorders and diseases.The Given® Diagnostic Imaging System may be used inhospitals, outpatient clinics and physician offices. After theM2A™ Capsule is ingested the patient is not restricted to amedical environment.ContraindicationsThe M2A™ Capsule is contraindicated for use under thefollowing conditions:• In patients suspected to suffer from intestinal obstructionbased on the clinical picture or pre-procedure testing andprofile.• In patients with cardiac pacemakers or other implantedelectromedical devices.• During pregnancy.• With patients who have known or suspectedgastrointestinal obstruction or strictures. Prior abdominalsurgery is a relative contraindication to the use of theM2A™ Capsule.
OverviewGiven Imaging Ltd. 10WarningsWarningsWarningsWarningsA Warning indicates a condition that may endanger thepatient or the operator.Warnings• The M2A™ Capsule should be used only after consultinga physician.• A thorough understanding of the technical principles,clinical applications and risks associated with the Given®Diagnostic Imaging System is necessary before using thisproduct. Read the entire manual before using the systemfor the first time.• To prevent the patient from being exposed to unforeseenrisks during passage of the M2A™ Capsule, make surethe patient thoroughly understands the procedure, andprovide the patient with a copy of the Patient Instructionsfor Undergoing Capsule Endoscopy. (You can print itfrom the RAPID™ Application.)• If there is reasonable doubt concerning the integrity ofthe M2A™ Capsule due to dropping, biting or any othereventuality, it should not be used until consulting with anauthorized Given® representative and should bedeactivated by returning it in its holder into its blister.• Do not use an M2A™ Capsule after its expiration date.• Instruct the patient to avoid biting the M2A™ Capsuleprior to swallowing.• After ingesting the M2A™ Capsule and until it isexcreted, the patient should not be near any source ofpowerful electromagnetic fields such as one created nearan MRI device.
OverviewGiven Imaging Ltd. 11• The patient should be instructed to contact the physicianimmediately if after ingesting the M2A™ Capsule he/shehas any abdominal pain, nausea or vomiting.• The patient should be instructed to keep the DataRecorder Waist Belt on throughout the procedure, for aminimum of 8 hours.• This M2A™ Capsule must be stored in a safe place outof the reach of children and/or infants.• If contrary to instructions a patient ingested two capsules,he/she should be instructed to contact the physicianimmediately.• If a child has accidentally swallowed an unused or spentM2A™ Capsule, the child should be broughtimmediately to a hospital.• The M2A™ Capsule should be ingested only in thepresence of authorized personnel. The patient should beinstructed not to let his/her relatives, neighbors oracquaintances use the M2A™ Capsule.• This device has not been tested in pediatric population(children 18 and below) and safety in young children isunknown.
OverviewGiven Imaging Ltd. 12PrecautionsPrecautionsPrecautionsPrecautionsA precaution indicates a condition that may damage theequipment.Precautions• USA Federal law restricts this device to sale by or on theorder of a physician.• Make sure that only trained personnel familiar with all ofthe Given® Diagnostic Imaging System operatingprocedures use the system.• Use the system only with components purchased fromGiven® Imaging Ltd. Use of other components can voidthe system’s warranty and may damage it.• When dispensing the M2A™ Capsule use the Capsule’sholder.• To ensure proper imaging acquisition, verify thefollowing:• The patient has fasted for a period of 8 hoursprior to the M2A™ Capsule ingestion.• The Battery Pack is fully charged.• The Sensor Array is properly attached to thepatient’s body.
OverviewGiven Imaging Ltd. 13Adverse EventsAdverse EventsAdverse EventsAdverse EventsIn patients with strictures of the gastrointestinal tract, theM2A™ Capsule can potentially cause intestinal obstructionresulting in the need for hospitalization and surgery. The useof the M2A™ Capsule in patients with strictures of thegastrointestinal tract is contraindicated.Based on the experience gained so far, there is no adverseevent related to the proper use of the Given® DiagnosticImaging System.
OverviewGiven Imaging Ltd. 14System LabelingSystem LabelingSystem LabelingSystem LabelingThe following table lists the labels attached to variouscomponents of the Given® Diagnostic Imaging System.Labeling ExplanationThe M2A™ Capsule should be stored and used at adistance from any powerful magnetic fields such as theone created by an MRI.The M2A™ Capsule is intended for single use only.Attention! Consult the documentation provided with theGiven® Diagnostic Imaging System.Class II equipmentType BF equipmentFCC compliance.!2
OverviewGiven Imaging Ltd. 15System SpecificationsSystem SpecificationsSystem SpecificationsSystem SpecificationsNote: Specifications are subject to change without prior notice and withoutany obligation to users on the part of the manufacturer.M2A™ CapsulePropertiesDimensions Length: 26mmDiameter: 11mmWeight 3.7 grPhysicalMaterial Biocompatible plasticIllumination 4 white light emitting diodesField of View 1400Effective Visibility Distance: 3 cmMagnification 1:8OpticalMin. DetectableObject Less than 0.1mmSampling Rate 2 fpsOperating Time 7 ± 1hoursMechanical Safety Passed 50 kg bite testChemical Safety Resistant to dissolution in pH=2to pH=8Battery Type Silver Oxide batteriesOperatingTemperature 20 - 45C0OperationalStorage Temperature 0 - 50C0
OverviewGiven Imaging Ltd. 16Data RecorderSoftware Proprietary firmwareRecording time Up to 10 hoursWeight 305 grBattery type External, nickel-metal, 6V, 6500mAHBattery Pack weight 912grSensor Array 8 flat 40 mm diameter flexible PCBOperatingTemperature 5 - 50C0Storage Temperature -40 - 70C0Shielding Shiledex® Supra, from Less EMF Inc.RAPID™ Application SoftwareSoftware RAPID™ proprietaryLanguages English/French/German/Italian/SpanishData export JPEG Images, AVI Movies, HTML ReportsDisplayed data Images, Timebar and other diagnostic data.Event marker Annotated thumbnailsViewing rate 1-25 fps REMOVE!!!
OverviewGiven Imaging Ltd. 17About this ManualAbout this ManualAbout this ManualAbout this ManualThis manual guides you through the use of the Given®Diagnostic Imaging System. It instructs you on how toconnect, and use the system.The manual is comprised of the following chapters:Chapter 1: Given® Diagnostic Imaging System –describes the Given® Diagnostic Imaging System,indications and contraindications, System specifications andthis Manual.Chapter 2: System Setup – instructs you on how to set upthe Given® Diagnostic Imaging System.Chapter 3: Getting to Know the RAPID™ Application –describes and instructs you on how to use the RAPID™Application.Chapter 4: Performing Capsule Endoscopy – instructs youon how to prepare and check in the patient, deploy theReceiving set and dispense the M2A™ Capsule. The chapteralso includes a troubleshooting section to guide you on howto cope with various potential difficulties.
OverviewGiven Imaging Ltd. 18ConventionsMenu, dialog box, tab and button names and options arebolded and begin with uppercase letters. For example: ClickSave or select the Save All option.Convention Explanation<Space bar> Keyboard keysFile > Open Open the File menu and select the Openoption.An important noteBulleted List A one step procedure or a list of items.• Click Open.Numbered List A multistep procedure. You need toperform the procedure step by stepaccording to the order of the steps.A warning!A precaution
OverviewGiven Imaging Ltd. 19Contacting Given® ImagingContacting Given® ImagingContacting Given® ImagingContacting Given® ImagingInformation and Technical support for the RAPID™Application and other system components is available from:Company Headquarters EuropeGiven Imaging LimitedPOB 258Yokneam, Israel 20682Tel: +972-4-909-7777Fax: +972-4-959-2466info@givenimaging.comNorth America Australia & New ZealandGiven Imaging Inc.Oakbrook Technology Center5555 Oakbrook Parkway, #355Norcross, GA 30093Tel: 770-662-0870 1-800-GIVENGIFax: 770-662-0510infousa@givenimaging.comGiven ImagingUnit 4, 277 Lane Cove RoadNorth Ryde, 2113, NSW,AustraliaPostal: Box 8, 293 Lane CoveRoadNorth Ryde, NSW, 2113,Tel: 0419 144 836infoaus@givenimaging.comWorldwide Supportsupport@givenimaging.com
Given Imaging Ltd.20Chapter TwoSystem SetupBefore Your System ArrivesBefore Your System ArrivesBefore Your System ArrivesBefore Your System ArrivesBefore the Given® Diagnostic Imaging System arrives inyour clinic prepare the following:• Five outlets: an outlet for the computer, monitor, powersupply, printer and an outlet for the charger.Note: You may use a multiple outlet.• Space for placing the system components: a computer,monitor and a printer.• Space next to the Workstation for the Connection Boxand its wiring (about 8-12 inches, 20-30 cm) and for theData Recorder.• A storage space protected from any powerfulelectromagnetic source for storing the M2A™ Capsule10-Pak box.
System SetupGiven Imaging Ltd. 21Connecting the SystemConnecting the SystemConnecting the SystemConnecting the SystemThis section describes the various connectors and cables ofthe Given® Diagnostic Imaging System and instructs you onhow to connect the system.Items to ConnectFollowing is a list of items you need to connect in order tosetup the Given® Diagnostic Imaging System:• RAPID™ Workstation• Monitor• Keyboard• Intel Mouse with Thumbwheel• Printer• Connection Box• Connection Box Power Supply• Data Recorder• Battery Pack• Telephone Connection• 9-pin Male-Female Cable• 9-pin Female-Female Cable• LAN Network Cable
System SetupGiven Imaging Ltd. 22Connecting the WorkstationUse the back panel of the workstation for connecting themonitor, keyboard, mouse, printer, LAN cable, modem, andthe Connection Box according to the scheme below:Workstation BackpanelPrinter Backpanel2USBLANNetworkSocketParallel/Printer PortSerial (com)Port 1Serial (com)Port 2KeyboardMouseTelephoneLineMonitor BackpanelMonitor Modem
System SetupGiven Imaging Ltd. 23The following table lists the connectors of the Workstationback panel:Connector ExplanationPower cord Connects the Workstation to the electric socket.Keyboard Connects the keyboard to the Workstation.Mouse Connects the mouse to the Workstation.Monitor Connects the monitor to the Workstation.Parallel Port Connects the Workstation to the printer.USB Port Connects the Workstation to the printer, alternative toParallel Port.LAN Connects the Workstation to the Connection Box to transferdata from the Recorder to the Workstation and vice versa.COM Connects the Workstation to the Connection Box.Modem Connects the Workstation to a phone line.
System SetupGiven Imaging Ltd. 24! To connect the workstation1. Connect the IntelliMouse (Intel Mouse w/Thumbwheel))cable to the Mouse connector.2. Connect the Keyboard cable to the Keyboard connector.3. Insert the LAN cable to the LAN connector.Note:The LAN cable is a special cable and cannot be replaced by astandard LAN cable4. Connect the Monitor cable to the Monitor connector.5. Insert the Modem cable to the Modem connector and theother jack phone connector of the Modem cable to thephone outlet.6. Connect the printer to the LPT connector or to the USBconnector, according to your printer connection cable.7. Connect the Connection Box cable to COM 1.8. Connect the Power cable of the monitor to the electricsocket.9. Connect the Power cable of the Workstation to theelectric socket.
System SetupGiven Imaging Ltd. 25Connecting the Connection BoxThe Connection Box connects between the Workstation andthe Data Recorder.The following table lists the connectors and indicators of theConnection Box.Connector/Indicator Explanation9-pin Male connector Connects the Connection Box to theWorkstation with a 9-pin Female-Female cableLAN connector Connects the Connection Box to theWorkstation with the LAN cable.Power Supply Connects the Connection Box to the electricsocket9-pin Female connector Connects the Connection Box to the recorderwith a 9-pin Male-Female cable.Control LED Indicates that the Connection Box is connectedto the electric socket and is operating.Workstation Backpanel2ConnectionBoxUSBLANNetworkSocketParallel/Printer PortSerial (com)Port 1Serial (com)Port 2KeyboardMouseNetwork Cable9 Pin Female-FemaleMonitorModemPowerSupply
System SetupGiven Imaging Ltd. 26! To connect the Connection Box1. Connect the 9-pin Male connector of the Connection Boxto the serial Com 1 of the Workstation with the 9-pinFemale-Female connection cable.2. Connect the LAN cable to the LAN connector of theConnection Box.3. Connect the Connection Box to the Power supply.4. Connect the Power supply to the electric socket.5. Verify that the Control LED is on.6. To connect the Recorder cable to the Connection Box,connect the Male connector of the Recorder cable to theFemale connector of the Connection Box.Note:Connect the Recorder to the Connection Box only wheninstructed to do so.
Given® Diagnostic Imaging System User’s ManualGiven Imaging Ltd.27System Setup SchemeOnce you have finished connecting the Given® Diagnostic Imaging System, use thefollowing figure to verify the various connections.Workstation BackpanelPrinter Backpanel2ConnectionBoxUSBLANNetworkSocketParallel/Printer PortSerial (com)Port 1Serial (com)Port 2KeyboardMouseNetwork Cable9 Pin Female-FemaleTelephoneLineMonitor BackpanelMonitor ModemDataRecorder 9 Pin Male-FemalePowerSupply
Given Imaging Ltd.28Chapter ThreeGetting to Know RAPID™Running the RAPID™ ApplicationRunning the RAPID™ ApplicationRunning the RAPID™ ApplicationRunning the RAPID™ ApplicationThe RAPID™ Application software complies with theconventions of Windows® operating system applicationsconventions. However, various functions of the Windowsoperating system are disables or modified to enable theproper function of the RAPID™ Application..During its operation, the RAPID™ Application writes filesand reads files from pre-defined locations on the RAPID™Workstation hard disks. Handle files only through theRAPID™ Application and not by using the WindowsExplorer application. Do not change directory and file names.Note: The directory and file names should not be modified unlessunder instructions from Given® Imaging technical support.There are two hard disks in the RAPID™ Workstation. Itallows a total separation of RAPID™ Application softwarefrom RAPID™ Application data. The RAPID™ Applicationdata is always written to disk E. Raw data downloaded fromthe Data Recorder is written to the Recorder data directory
RAPID™ ApplicationGiven Imaging Ltd. 29while PRR data is written to Patient Rapid Report directory .Data in these subdirectories should never be meddled with.Before using the RAPID™ Application, you should create a“User” subdirectory on drive E:\. Whenever he saves imagesas files, use the “User” subdirectory. To copy files from theRAPID™ Workstation use only the “User” subdirectory.Running the RAPID™ Application is very easy and simple.All you need to do is to double-click the RAPID™Application icon that appears on the Workstation desktop.! To run the program1. Turn on the computer. The Windows desktop appears2. Double click the RAPID™ Application icon.The RAPID™ Application is running and the mainscreen appears.Selecting a LanguageYou can change the language of the RAPID™ Application.By default, the RAPID™ Application language is English.You can change it to either one of the following languages:• French • Spanish • GermanFor the language change to take effect, you have to restart theRAPID™ Application.! To change the language1. Select Tools > Options.
RAPID™ ApplicationGiven Imaging Ltd. 30The Options window appears:2. Open the Language drop-down list and select the desiredlanguage.3. Click OK.4. Select File > Exit option to close the application.5. Double click the RAPID™ Application icon to re-run theprogram.The RAPID™ Application is running with the languageof your choice.Changing Display SettingsThe RAPID™ Application is supplied with a defaultAutomatic display setting. With this setting, the RAPID™Click hereto select alanguageAutomaticE:\rdataE:\trials
RAPID™ ApplicationGiven Imaging Ltd. 31Application Main Screen has a resolution of 480x640 pixels.This setting enables a clear view of the PRR movie.You can change the display settings of the RAPID™Application to reduce the size of the RAPID™ Main Screen.For the display setting change to take effect, you have torestart the RAPID™ Application.! To apply specific display settings1. Select Tools > Option.The Options window appears.2. Open the Display Settings drop down list and selectNone.3. Click OK.4. Select File > Exit option to close the RAPID™ Application.Click hereto selectdisplaysettingsAutomaticE:\rdataE:\trials
RAPID™ ApplicationGiven Imaging Ltd. 325. Double click the RAPID™ Application icon.Changing the UnitsYou can set the unit of measure for the measurements thatyou type in dialog boxes. By default, the RAPID™Application is using centimeters and kilograms. You can setthe unit of measure to inches and pound.! To change the unit of measure1. Select Tools > Options.The Options window appears:Click here toselect theunit ofmeasureE:\rdataE:\trialsAutomatic
RAPID™ ApplicationGiven Imaging Ltd. 332. Open the Measurement System drop-down list andselect the desired measurement system.3. Click OK.The RAPID™ Application is running with the unit ofmeasure of your choice.Main ScreenMain ScreenMain ScreenMain ScreenThe RAPID™ Main Screen enables you to watch the PRRmovies and to diagnose irregularities in the gastrointestinaltract. The following sections introduce you to the varioussections of the RAPID™ Main Screen and guide youthrough the various available menu options.ThumbnailsectionVideosectionTimebarsection DisplayspatientdetailsMain screenmenusControl buttonsIndicates the time of thecurrent image
RAPID™ ApplicationGiven Imaging Ltd. 34The RAPID™ Main screen is comprised of the followingsections:• Title bar• Menu section.• Video section• Thumbnail section• Timebar section
RAPID™ ApplicationGiven Imaging Ltd. 35Title BarThe title bar displays the patient ID, initials and test date.You entered these details during the Check-In process andthey were derived from the recorder during download.Main Screen MenusThe drop-down menus of the RAPID™ Main Screen enableyou to use the various options available through the menus.The following tables list the various menus and their options.
RAPID™ ApplicationGiven Imaging Ltd. 36File MenuThe File menu enables you to open or to save the PRRmovies and groups of thumbnails and to quit the RAPID™Application.Option ExplanationOpen Enables you to select a PRR movie ofprevious examinations.Save Video As Saves the video under a different file name.However, while watching the movie, thename of the movie as derived from therecorder appears in the Title bar.Open Thumbnail Opens a selected file of thumbnails.Save Thumbnails As Saves a selection of thumbnails as a GRMLfile. The file name is comprised of themovie name from which you created thereproductions with the extensionTN.GRML.Print Screen Creates a printout of the RAPID MainScreen with the current display.Print Setup Opens the standard Print window.File list Displays a list of the last 7 files you opened.Exit Quits the RAPID™ Application.
RAPID™ ApplicationGiven Imaging Ltd. 37Video MenuThe Video menu enables you to control the PRR movie.Option ExplanationStep Forwards Moves forward to the proceeding frame.Step Backwards Moves backward to the previous frame.Play Forwards Starts the movie.Play Backwards Plays the movie backward.Pause Temporarily stops the movie presentation.Restart Restarts the movie.End Moves the PRR movie to the last frame.Go To Frame Moves the movie to a frame that matches aspecific time indication.CaptureThumbnail Duplicates a frame along with 100 adjacentimages, 50 before and 50 after the thumbnail.
RAPID™ ApplicationGiven Imaging Ltd. 38Online MenuThe Online menu enables you to check in a patient and todownload and construct a PRR movie.Option ExplanationPatientCheck-In Opens the Recorder Initialization screen.RecorderDownload Opens the Recorder Download screen.Service This option is enabled only for an authorizedGiven® technician.ToolsThe Tools menu allows you to change the RAPID™Application interface and to set the source and target pathprior to the download.Option ExplanationOptions Defines the RAPID™ Application interfacelanguage, movie speed, Data Recorder directoryand the Patient RAPID Report directory prior tothe download.Help Provides information on the RAPID™Application version. It also enables you to printthe Patient Instructions for Undergoing CapsuleEndoscopy and the RAPID™ Application User’sManual.
RAPID™ ApplicationGiven Imaging Ltd. 39Video SectionThe Video section includes the presentation area and theControl Buttons. The Control Buttons are located at thebottom of the Video section and they allow you to do thefollowing:• Set the projection rate• Play/stop the movie• Move backwards or forwards frame by frame• Move to the last frame• Rewind the movie• Create thumbnails.The Video section also displays the exact time of each framethat is currently projected, as derived from the Recorder.Thumbnail SectionThe Thumbnail section presents images from the movie, andenables you to annotate the snap shots. For furtherinformation, refer to Thumbnail Section on page 60.Timebar SectionThe Timebar section is synchronized with the PRR movieand it displays the time in relation to the frame currently
RAPID™ ApplicationGiven Imaging Ltd. 40presented in the Video section. In addition it presents thetime of any thumbnail. For further information, refer toTimebar on page 68.
RAPID™ ApplicationGiven Imaging Ltd. 41Patient Check-InPatient Check-InPatient Check-InPatient Check-InThe RAPID™ Application enables you to check in thepatient who is intending to undergo the Capsule Endoscopy.The checking in process includes the following:• Patient Registration – filling in the Registrationcomputerized form.• Recorder Initialization – downloading patient details tothe Recorder.• Disconnecting the Recorder.! To check in a patient1. Select Online > Patient Check-In.The following screen appears guiding you throughconnecting the Recorder.
RAPID™ ApplicationGiven Imaging Ltd. 422. Follow the instructions on the Recorder Initializationscreen:Verify that the Connection Box is connected to thecomputer.Verify that the power supply is connected to the electricsocket.Verify that the Connection Box is connected to the powersupply.Verify that the Recorder is NOT connected to theConnection Box.Note:Connect the Recorder to the Connection Box only wheninstructed to do so.3. Click Yes.The Add New Patient window appears.
RAPID™ ApplicationGiven Imaging Ltd. 434. Under Patient Initials enter the information as follows:In F, enter the first letter of the patient’s first name.In L1, enter the first letter of the patient’s last name.In L2, enter the second letter of the patient’s last name.5. Under ID, enter the number of patient in the clinicalprotocol.Enterpatient’sdetailsEnterprotocolnumber anddate of testMessagesareaClick toinitialize theRecorderClick tocancel
RAPID™ ApplicationGiven Imaging Ltd. 446. Open the Gender drop-down list and select the requiredgender.7. Under Birth Date, click the arrow and select the requireddate of birth.8. Open the Physique drop-down list and select eitherskinny, normal, stocky or potbelly. Use the followingfigure:skinnyskinny stockystockynormalnormal potbelliedpotbellied9. Under Protocol Number, enter the code of the clinicaltrial protocol, you have been assigned by Given®Imaging Limited, Division of Medical Affairs.10. Under Test Date, enter the date of the test.11. Click Check-In Patient.In the Message area, a message appears asking you toconnect the Data Recorder to the Data Recorder cable.12. Connect the Data Recorder to the Data Recorder cable.Connect the 9-pin Female connector of the Data
RAPID™ ApplicationGiven Imaging Ltd. 45Recorder cable to the 9-pin Male connector of the DataRecorder.In the Message area, a message appears notifying youthat the Recorder initialization starts. The details youentered during the patient registration are saved in theData Recorder directory and are downloaded to the DataRecorder.Upon completion, a message appears notifying you thatthe Data Recorder initialization is complete.Once the initialization process is complete a messageappears asking you to disconnect the Data Recorder.13. Disconnect the Recorder from the Data Recorder cable.
RAPID™ ApplicationGiven Imaging Ltd.46Creating a MovieCreating a MovieCreating a MovieCreating a MovieOnce you open the RAPID™ Application Main Screen andyou wish to watch a PRR movie, perform either one of thefollowing:• Create a movie.• Select and watch an existing movie.Creating a PRR MovieTo create a movie, you need to download raw data from theRecorder to the workstation. This process is comprised oftwo stages:• Defining Data Recorder and Patient RAPID Reportdirectories.• Connecting the Recorder to the workstation.Defining DirectoriesRecorder data directory - Define a directory for saving thedownloaded raw data. The default path is:E:\rdata.Patient Rapid Report directory - Define a path for saving theprocessed data, i.e., the PRR movie. The default path is:E:\trials.
RAPID™ ApplicationGiven Imaging Ltd. 47! To define the directories1. Select Tools > Options.The Options window appears:2. The default Recorder Data directory is:E:\ rdata. You should not change this setting unlessinstructed so by Given® Imaging technical support.To change the setting, click Modify and define the pathof your choice.3. The default Patient RAPID Report is:E:\trials. You should not change this setting unlessinstructed so by Given® Imaging technical support.To change the setting, click Modify and define the pathof your choice.4. Click OK to apply the changes and to close the Optionswindow.Definehere adirectoryDefinehere adirectoryClick tomodify thedefaultInput orOutputpathAutomaticE:\rdataE:\trials
RAPID™ ApplicationGiven Imaging Ltd. 48Note:The Data Recorder requires a shared \rdata directory in orderto be able to download data to the workstation. This directoryshould not be modified unless under instructions fromGiven® Imaging technical support.Connecting the Recorder and DownloadingOnce you have defined directories for saving the downloadedand the processed data, you can connect the Recorder anddownload the raw data. The RAPID™ Application guidesyou on how to connect the Recorder to the workstation. Allyou need to do is to follow the instructions on the screen.! To connect the recorder and start downloading1. Select Online > Recorder Download option.The Recorder Download window appears.
RAPID™ ApplicationGiven Imaging Ltd. 492. Follow the instructions that appear on the RecorderDownload screen:• Verify that the Connection Box is connected to thecomputer.• Verify that the power supply is connected to theelectric socket and to the Connection Box.• Verify that the Recorder in NOT connected to theConnection Box.3. Verify that all files in the Recorder data directory pathcan be deleted. If they cannot be deleted, click Canceland re-define a shared \rdata Recorder data directorypath.Note: If, in the Recorder Download window, you click Cancel, thedownload does not start and we advise you to define a new DataRecorder directory.4. To proceed, click OK.A message appears asking you to connect the DataRecorder to the Connection Box.5. Connect the Data Recorder to the Recorder cable.All raw data is being downloaded and simultaneously themovie is being constructed and saved in the PatientRAPID Report directory. During the construction, themovie is projected in the Video section. Once thedownload and the construction are complete, messagesappear respectively. The first frame of the movie appearsin the Video section.
RAPID™ ApplicationGiven Imaging Ltd. 50PRR Movie NameOnce the download process is complete, a new PRR movieappears in the Output path you have defined. The movie filename is comprised of the following components separated byan underscore. The components are derived from theRecorder during the download process:• A prefix (GI)• Patient’s initials• Examination date in the following format:(YYYY/MM/DD)• Patient number• File extension (GTD)For example, the file name GI_JBS_2000/12/06_12349.GTD isa PRR movie of a patient number 12349 whose initails are JBSand who went through the examination on 12/06/2000.Precaution!Do not modify the files in the Patient RAPID report directory inany way. Modification may result in loss of files.Selecting an Existing MovieThe PRR movies are stored on the workstation in theVideo folder unless you choose to save them in anotherlocation or under a different name.
RAPID™ ApplicationGiven Imaging Ltd. 51If you saved a movie under a different name, once you openthe file and watch the movie, the Title bar of the RAPID™Main Screen displays the original movie name.! To select a movie1. In the RAPID™ Main Screen, select File > Open.The Open window appears indicating the defaultdirectory of the PRR movies.2. The default directory of the PRR movie appears. If youstored the video in another location, navigate to the desiredlocation.3. Select the desired movie (*.gtd file) and click Open.Once the movie is loaded the first frame appears in theVideo section and you can start watching the movie.Guidelines for Watching the Movie• Verify that the display setting is Automatic. If not,increase the RAPID™ Application resolution by settingdisplay setting to Automatic.• Dim the lights in the room.
RAPID™ ApplicationGiven Imaging Ltd. 52Watching the PRR MovieThe Video section enables you to watch the video capturedby the M2A™ Capsule during the examination. The PRRmovie is comprised of a series of single images and it canpresent from 1 to 25 frames per second according to theselected movie speed.Primary Screening of the MovieA primary screening of the movie is available while watchingthe movie in Automatic speed mode. The Automatic speedmode changes from a fast display rate to a slow rateaccording to differences between consecutive images. Whenthe RAPID™ Application detects large differences betweenadjacent images, it slows down the show rate to enable abetter look at the images.The video presentation is synchronized with the Timebarsection. The Timebar progresses as the movie progresses.To control the movie presentation, use the Control Buttonslocated at the bottom of the Video section. The followingtable lists the Control Buttons and the action each buttonprovides:
RAPID™ ApplicationGiven Imaging Ltd. 53Button Action Video speed Selects the projection rate. The availablerates are Automatic, Slow and Fast. TheVideo Speed button changes according tothe selected speed. Restart Restarts the movie. Back Step Moves back to the previous frame. Play backward Plays the movie backward. If you click thePlay backward button, the Play forwardbutton changes to the Pause button whilethe movie is playing. PlayforwardPlays the movie forward. If you click thePlay forward button, the Play backwardbutton changes to the Pause button whilethe movie is playing. PauseStops the movie and a still picture appears.The Pause button changes to a Playbutton. ForwardMoves forward to the next image.
RAPID™ ApplicationGiven Imaging Ltd. 54Step EndMoves to the last frame of the movie. CaptureThumbnailDuplicates a frame. The duplicationimmediately appears in the Thumbnailsection.Selecting the PRR Movie SpeedThere are three available modes of the PRR movie speed:Automatic, Fast and Slow.Automatic – automatically sets the display rate of the images(between maximum 25 frames per second and a minimum 5frames per second) according to the rate of change insuccessive images. When the RAPID™ Application detects alarge difference between successive images, it slows downthe show rate to enable a careful examination of the pictures.Fast – displays the movie in fast speed of 10 frames persecond (default). You can change the Fast rate by selectingTools | Options.Slow – displays the movie in slow speed of 5 frames persecond (default). You can change the Slow rate by selectingTools | Options.
RAPID™ ApplicationGiven Imaging Ltd. 55Setting the Fast and Slow Speed RateBy default the fast speed is 10 frames per second and theslow speed is 5 frames per second. The Options windowallows you to change the default settings of the Fast andSlow modes.! To change the default settings of Fast and Slow modes1. Select Tools > Options.2. The Options window appears.3. Under Slow select the desired speed rate for the Slowmode.4. Under Fast select the desired speed rate for the Fastmode.The default speed mode of the movie is Automatic. You caneasily switch between the modes of speed.! To select a speed mode• Click the Video Speed button to select thedesired speed mode. The letter that appearson the Video Speed button indicates theselected speed.Set thedesiredspeedfor theSlowmodeSet thedesiredspeedfor theFastmodeAutomaticE:\rdataE:\trials
RAPID™ ApplicationGiven Imaging Ltd. 56Restarting the MovieWhen you restart the movie, the time and frame indicationsare automatically updated along with the Timebar.! To restart the movie• Click the Restart button.The PRR movie starts from the beginning andthe related features such as the Time andFrame indications at the bottom of the Videosection automatically resets to zero.Moving by FramesYou can move along the movie one frame forward orbackward, or to the last frame. While moving along themovie, the related features are updated accordingly.! To move by frames• To move one frame forward, click theForwards Step button.The movie moves one frame forward.• To move one frame backward, click the BackStep button.The movie moves one frame backward.
RAPID™ ApplicationGiven Imaging Ltd. 57• To move to the last frame in the PRR movie,click the End button. The movie moves to thelast frame and the time indication at the bottomof the Video section representing the end ofthe study, is automatically updated.Moving by Time IndicationYou can move to a certain section of the movie by indicatinga time unit in the Time text box at the bottom of the Videosection. The movie automatically moves to the related sectionof the movie.! To move by time indication1. In the Time text box at the bottom of the Video section,type in the desired time in the following format:HH:MM:SS.2. Press the <Enter> key on your keyboard.The movie automatically scrolls to the desired videosection and the Timebar is updated accordingly.
RAPID™ ApplicationGiven Imaging Ltd. 58Playing and PausingWhen you watch the movie and you would like to have alonger look at one of the frames, you can temporarily stop theprojection of the movie.! To Play/Pause the PRR MovieTo play the movie, click the Play forward button. Themovie is on. The Play backward button changes to thePause button.To play the movie, click the Play backward button.The movie is on. The Play forward button changes to thePause button.To pause the movie, click the Play button.The movie stops playing, the current frame appears as astill picture and the Pause button changes to Play.
RAPID™ ApplicationGiven Imaging Ltd. 59Capturing an ImageWhen you capture a frame the following occurs:• The captured frame immediately appears at the bottom ofthe Thumbnail section. The time indication derived fromthe Recorder appears next to the captured frame in theThumbnail section.• An indication of the thumbnail appears in the Timebarsection of the RAPID™ Main screen.! To capture a frame1. 1. While the movie is playing, click Pause.2. While the movie is still, click Capture Picture.The selected frame appears with a time indication in theThumbnail section. An indication that a thumbnail wascreated appears in the Timebar section.
RAPID™ ApplicationGIven Imaging Ltd.60Thumbnail SectionThumbnail SectionThumbnail SectionThumbnail SectionThe Thumbnail section displays images captured from thePRR movie. Each reproduction appears in the Thumbnailsection with a time indication derived from the Recorder andthe first few words of the attached comment.Once you have captured three images, a scroll bar appearsalong the right side of the Thumbnail section. Use thisscrollbar to scroll through the captured images.You can scroll through the thumbnails, save, delete and editany of the comments attached to the picture. You can alsomove from a thumbnail to its exact location in the movie andview the adjacent pictures. Any of these operations requiresthe selection of a thumbnail.Selecting a ThumbnailYou can select one, a few or all thumbnails. Follow theprovided instructions according to your needs.! To select a thumbnail• Move the mouse pointer to the desired thumbnail andclick.A blue square appears over the thumbnail.A picture capturedfrom the movieTime indicationderived from theRecorderThe first word ofthe attachedcommentDrag the scrollbar to scrollthrough thethumbnails
RAPID™ ApplicationGiven Imaging Ltd. 61! To select several thumbnails1. Select a thumbnail.2. Move the mouse pointer to another frame you wish toselect and simultaneously click the mouse and the <Ctrl>key of your keyboard; both selected thumbnails arecovered by a blue square.3. Repeat step 2 until you selected all the desired pictures.
RAPID™ ApplicationGiven Imaging Ltd. 62! To select all thumbnails1. Select the thumbnail at the top of the Thumbnail section.2. Scroll to the last thumbnail and simultaneously click themouse and the <Shift> key of your keyboard; allthumbnails are selected.Scrolling through the ThumbnailsTo scroll through the thumbnails, use the scroll bar located onthe right side of the Thumbnail section. The thumbnails arearranged according to the sequence of capturing. The lastthumbnail appears at the bottom of the Thumbnail section.Scrolling up reveals the more recent Thumbnails andscrolling down reveals the previous ones.! To scroll through the thumbnails• To observe a thumbnail previously captured, drag thescroll bar toward the top of the main screen.• To view the most recently captured thumbnail, drag thescroll bar toward the bottom of the main screen.
RAPID™ ApplicationGiven Imaging Ltd. 63Saving a ThumbnailWhen you save a thumbnail, you actually save the thumbnailAND a short movie. The movie is comprised of 100 adjacentframes, 50 frames before and 50 frames after the selectedframe. To watch this short movie, use any Windows mediaplayer, which is already installed on the Workstation.The thumbnail is saved as a JPEG file and the short movie asan AVI file. You need to select only the location for savingthe thumbnail. The RAPID™ Application automaticallysaves the thumbnail as a *.jpg and an *.avi file in the selectedlocation.The file name of the *.jpg and the *.avi file contains the samecomponents as the PRR movie they were captured from. Forfurther information, see PRR Movie Name on page 50.! To save a thumbnail1. Click a thumbnail to select it.A blue square appears over the thumbnail.2. Click the right mouse button.A popup menu appears.3. Select Save.A window appears.4. Select a folder for saving the thumbnail.5. Click OK.
RAPID™ ApplicationGiven Imaging Ltd. 64The thumbnail is stored in the location of your choice asa JPEG and an AVI file, and a message appears notifyingyou that the operation is complete.! To watch a the AVI movie1. Open the Windows media player.2. Navigate to the *.avi file of the thumbnail you wish toexamine.3. Select the file.4. Click OK.The short movie of 100 images is running.Saving a Group of ThumbnailsYou can save a group of thumbnails as an independent file.This file name contains all of the components of the PRRmovie file name with the extension tn.grml, i.e., GI_(patientinitials_examination date_patient number_tn.grml.! To save a group of thumbnails1. From the File menu, select File > Save As Thumbnailsoption.The Save As window appears.2. Select a folder for saving the thumbnails.3. Click Save.The group of thumbnails is saved as a file that its name isidentical to the PRR movie file name with the extensiontn.gml.
RAPID™ ApplicationGiven Imaging Ltd. 65Removing a Thumbnail1. Select a thumbnail.A blue square appears over the thumbnail.2. Click the right mouse button.A popup menu appears.3. Select Delete; the reproduction disappears from theThumbnail section.Creating or Editing a CommentIf you want to annotate a Thumbnail by entering a commentor to edit a comment, do the following:! To edit a comment1. In the Thumbnail section, select a thumbnail.2. Click the right mouse button; a menu appears.3. Select Comment.The Enter Comment window appears:4. Type in a comment, or edit the existing comment.Enter hereyourcomment
RAPID™ ApplicationGiven Imaging Ltd. 665. Click OK to save the changes and to close the Commentwindow.Reading the CommentIn the Thumbnail section, you can read the annotatingcomment of a thumbnail by placing the pointer of the mouseon the beginning of the comment that appears below thethumbnail.Move the mousepointer to here toview the completecomment
RAPID™ ApplicationGiven Imaging Ltd. 67! To read the comment• Position the mouse pointer on the first word of thecomment located under the thumbnail.The full comment appears and you can read it.Moving from a Thumbnail to the MovieIf you wish to look at the images adjacent to the capturedone, you can move from the Thumbnail section to the Videosection. The PRR movie automatically displays the capturedframe to enable you to look at what preceded or followed thecaptured frame.! To move from a thumbnail to the movie1. Select the desired thumbnail.A blue square appears over the thumbnail.2. Click the right mouse button.A popup menu appears.3. Select Go To; the movie automatically updates to displaythe desired frame. Use the Forward and Backward Stepbuttons to view the adjacent pictures.
Given® Diagnostic Imaging System User’s ManualGIven Imaging Ltd.68TimebarTimebarTimebarTimebarThe Timebar indicates the time as derived from the Recorderduring the movie projection. The Timebar is synchronizedwith the movie and it moves along indicating the elapsedtime by changing the moving bar into light blue.When you create a thumbnail, the Timebar section presentsthe first word of the thumbnail annotation as the followingfigure shows:The section of themovie you havealready watchedThe section of themovie you did notwatchThumbnailsthat werecaptured
RAPID™ ApplicationGiven Imaging Ltd. 69Scrolling Through the MovieYou can scroll through the movie by dragging the Timebarup or down. The movie presentation is updated accordingly.! To scroll through the movie• Drag the gray area of the Timebar up, to view the firstsection of the movie and down to view the last section ofthe movie.The displayed PRR movie is updated accordingly.Moving from Comment Indication to FrameIf you select a comment indication in the Timebar section themovie automatically moves to the frame belonging to theselected comment.! To move from comment to frame• In the Timebar section, select a comment.The comment indication appears in red, the mousepointer changes to red and the frame that the commentrefers to appears in the Video section.
Given Imaging Ltd.70Chapter FourPerforming Capsule EndoscopyOnce the Given® Diagnostic Imaging System is connectedand ready for use and you are familiar with the system andthe RAPID™ Application, you can perform a CapsuleEndoscopy.Performing a Capsule Endoscopy consists of the following:• Preparing the patient.• Preparing the examination set for the patient.• Checking in the patient.• Deploying the Data Recorder Set.• Dispensing the M2A™ Capsule.• Discharging the patient.• Receiving from the patient the Data Recorder, SensorArray, Battery Pack and Waist Belt.• Downloading data from the Data Recorder to theWorkstation and processing it to a PRR movie.
Capsule EndoscopyGiven Imaging Ltd. 71Preparing the PatientOnce you have decided that the patient should undergo theCapsule Endoscopy, inform the patient that the CapsuleEndoscopy involves the following:• Ingesting a small (the size of a large vitamin pill) Given®Imaging M2A™ Capsule which will pass naturallythrough the patient’s digestive system while takingpictures of the intestine.• Attaching to the abdomen a Sensor Array. The imagescaptured by the M2A™ Capsule are transmitted to theSensor Array.• Wearing a belt around the waist during the examination,which lasts approximately 8 hours. The belt contains aWalkman®-like Given® Data Recorder which saves allthe images and shielding that ensures FCC compliance.The belt must be worn at all times throughout theprocedure, a minimum of 8 hours.• Returning the Data Recorder set for further processing.Inform the patient in writing and verbally that he/she needs todo the following to achieve accurate results:• Abstain from food and drink for 8 hours prior toundergoing the Capsule Endoscopy.• Male patients should shave their abdomen 6 inches aboveand below the navel.• After ingesting the M2A™ Capsule, the patient shouldnot eat or drink for 2 hours. After 2 hours the patient maydrink water. After four hours the patient may have a lightsnack. After the completion of the study, the patient mayreturn to his/her normal diet.
Capsule EndoscopyGiven Imaging Ltd. 72• After ingesting the M2A™ Capsule, the patient shouldimmediately contact the physician’s office if he/she hasany abdominal pain, nausea or vomiting.• After ingesting the M2A™ Capsule and until it isexcreted, the patient should not be near any source ofpowerful electromagnetic fields such as one created nearan MRI device• During the examination, the patient should avoid anystrenuous physical activity. He/she should not bend orstoop during the Capsule Endoscopy.• During the examination, the patient should check every15 minutes that the green light at the top of the DataRecorder is blinking. If it stops blinking during the first 6hours of the examination, the patient should write downthe time and contact the physician’s office.• During the examination, the patient should not removethe Data Recorder belt.• In the Event Form, the patient should write down the timeand the nature of any event such as eating, drinking andunusual sensations. The patient will have to return thisform along with the examination set.Note:Before the patient leaves the clinic, you should give the patientthe Event Form along with a copy of the Patient Instructions forUndergoing Capsule Endoscopy.
Capsule EndoscopyGiven Imaging Ltd. 73Preparing Patient Examination SetVerify that the Given® Diagnostic System is set up accordingto the instructions provided in the Connecting the System onpage 21, and that you have the following equipment andaccessories:• M2A™ Capsule• Data Recorder• Sensor Array• Charged Battery Pack• Belt with belt extension, pouches and suspenders.• Application kit (10 adhesive sleeves, a Sensor Template,two adhesive pads).• Marker• Razor• Disinfectant• Measuring tape• ScaleChecking In a PatientThe Check-In procedure is done through the RAPID™Application. The procedure includes entering the patient’sdetails and initializing the Data Recorder. Before you startchecking in the patient, verify the following:• The RAPID™ Workstation has a shared \rdata directory.
Capsule EndoscopyGiven Imaging Ltd. 74• The \rdata directory is defined as the Data Recorderdirectory.• The RAPID™ Application is configured according toyour convenience, i.e., the language, screen settings andmeasurement system.• The patient abstained from eating or drinking for the last8 hours.• The patient did not take any medication in the last 2hours.• The patient (if male) shaved the area of the abdomen 6inches above and below the navel.For further information, on how to check in, refer to thePatient chapter on page 41.Deploying the Data Recorder SetDeploying the Data Recorder Set includes the following:• Adjusting the Recorder-Battery belt.• Connecting belt components.• Attaching the Sensor Array to the patient.• Putting the belt on the patient.
Capsule EndoscopyGiven Imaging Ltd. 75Adjusting the Recorder Battery BeltThe Recorder-Battery belt is an external belt that the patientwears during the examination. It contains two pouches forholding the Recorder and the Battery pack. It is importantthat the belt fits the patient and the patient is comfortablewearing the belt.! To fit the Recorder-Battery belt1. Ask the patient to stand up.2. Place the belt around the patient’s waist.3. Adjust the belt to fit the patient. For shorter patients, itwill be necessary to add the belt extension.4. Make sure that the Battery Pack and the Recorder pouchare at the patient’s waist as the following figure shows:5. Adjust the suspenders to fit the patient.6. Remove the belt.7. Place the belt next to the Battery Pack and the Recorder.
Capsule EndoscopyGiven Imaging Ltd. 76Connecting Belt ComponentsThis section instructs you on how to connect the Battery Packto the Recorder and how to secure both Battery Pack and theData Recorder in their pouches.Note:Since fully charged batteries slowly discharge, use only a BatteryPack you have just charged. For information on how to charge theBattery Pack, refer to Charging the Battery Pack on page 88.! To connect belt components1. Place a recently fully charged Battery Pack in the batterybelt pouch.2. To connect the Battery Pack to the Data Recorder,connect the 9-pin Female connector of the Battery Packcable to the 9-pin Male connector of the Data Recorder.3. Secure with the securing screws.Note: While connecting the Battery Pack to the Data Recorder, hold theData Recorder.The Data Recorder green LED blinks, turns on and thenoff. Once the recording starts the LED blinks at thereceiving rate.4. Insert Data Recorder into the Data Recorder pouch, andbring the Battery Pack cable out from the top opening ofthe pouch. (See the following picture).
Capsule EndoscopyGiven Imaging Ltd. 775. Use the Velcro straps to secure the Data Recorder andBattery Pack cable.6. Fold the remaining length of the Battery Pack cable andsecure it with the Velcro flap along the back of the belt.7. Put the belt aside until the patient is ready to wear it.WarningDo not connect the Data Recorder to the RAPID™Workstation while Data Recorder is connected to theSensor Array that is worn by the patient or while the WaistBelt is in the belt being worn by the patient.
Capsule EndoscopyGiven Imaging Ltd. 78Attaching the Sensor Array to the PatientThe Sensor Array is attached to the patient’s abdomen.Use the Sensor Template to place each one to the eightsensors of the Sensor Array in its correct location.
Capsule EndoscopyGiven Imaging Ltd. 79Necessary equipment and accessoriesThe M2A™ Capsule 10-Pak of the Given® DiagnosticImaging System also includes the Sensor Application kit. Thekit contains the following items which are necessary fordeploying the Sensor Array:Item ExplanationSensor Template Helps you position each one of the eightsensors in their proper location.Marker Enables to mark the location of each sensor.AdhesiveSleeves Holds each one of the eight sensors andsecurely attaches each one of the sensors to itsplace.Adhesive Pads Enables secure attachment the Sensor Arraycable to the patient’s hip.DisposableRazor Removes any hair from the abdomen.Warning Do not use the Sensor Array if it is torn or damaged.
Capsule EndoscopyGiven Imaging Ltd. 80The template has 9 holes. Eight holes indicate therecommended location of each one of the eight sensors andthe additional hole indicates the navel as a reference point.Place the template on the patient’s abdomen and use themarker to make a small dot at each location.Remove the template and locate each sensor over the dot.Securely attach the eight sensors to the patient’s body withthe adhesive sleeves. The adhesive sleeves are supplied withthe Sensor Application kit.To secure the Sensor Array cable to the patient’s hip, use theadhesive pads. The adhesive pads are supplied with theSensor Application kit.Note: Any object which comes in between the patient’s body andthe sensors, including hair or air, and any changes in thesensors arrangement may interfere with the quality of thedata.! To attach the Sensor Array1. Insert each sensor into an adhesive sleeve. The sensormarkings (dots or “THIS SIDE UP”) should face awayfrom the patient and the adhesive side of the sleeveshould face the patient’s abdomen.
Capsule EndoscopyGiven Imaging Ltd. 812. To secure the sensor in the sleeve, remove the liner fromthe adhesive line at the opening of the adhesive sleeveand press both lips together.3. Ask the patient to lie down and to expose his/her stomacharea down to the pubic bone.4. If a male patient arrives unshaven, wipe the patient’sabdomen with disinfectant and shave the abdomen 6inches above and below the umbilicus (navel).5. To mark the location of each sensor, place the SensorTemplate on the patient’s stomach with the drawingfacing up while using the navel as a reference point andinsert the marker into the holes. Mark the location ofeach sensor.6. Remove the Sensor Array Template from the patient andkeep it for reference until you complete the procedure.7. Place the Sensor Array on the patient’s abdomen using asa guideline the numbers on each sensor wire and thenumbers on the Sensor template. The Sensor Arrayconnector should be at the LEFT SIDE of the patient.8. To attach each sensor, start with the rightmost sensor.Remove the protective backing from its Adhesive Sleeve.Secure the sensor to the patient’s abdomen so that thehole at the center of the sleeve approximately overlapsthe marking on the patient’s abdomen.9. Repeat step 1 - 8 for all sensors.
Capsule EndoscopyGiven Imaging Ltd. 8210. To secure the Sensor Array cable to the left side of thepatient’s body, use the remaining adhesive pads as thefollowing scheme shows:11. Instruct the patient to get dressed. The Sensor Arrayconnector and approximately 10 inches of cable shouldremain outside of the patient’s clothes.Putting the Belt on the PatientSince you adjusted the belt, putting it on the patient is veryquick and simple.! To put the belt on the patient1. While the patient is standing, place the Recorder-BatteryPack belt around the patient’s waist.Note:The Sensor Array connector and wire should dangle from abovethe belt.2. To connect the Sensor Array to the Recorder, insert theSensor Array 8-pins male connector to the 8-pins Femaleconnector at the top of the Recorder. Verify that theprotrusion of the Sensor Array connector is facingoutwards.
Capsule EndoscopyGiven Imaging Ltd. 833. Instruct the patient that the belt should not be removedduring the course of the examination for any reason, atleast 8 hours.
Capsule EndoscopyGiven Imaging Ltd. 84Dispensing the M2A™ CapsuleBefore dispensing the capsule ascertain that there is no otherM2A™ Capsule or other diagnostic capsule in the patient’sgastrointestinal tract.Note: Verify that you read the Indications and Contraindications,Warnings and Precautions in the Package Insert of the M2A™Capsule or in chapter one prior to dispensing the M2A™Capsule.! To dispense the M2A™ Capsule1. Prepare a glass of water for the patient.2. To activate the M2A™ Capsule, open the blistercontaining the M2A™ Capsule.3. Take the capsule with its holder out of the blister.The capsule should start blinkingNote: If for any reason, after activating the M2A™Capsule by removing it from it’s blister, the patientis not taking the M2A™ Capsule, it should bedeactivated by replacing it, in its holder, to theblister. The capsule should stop blinking. If it doesnot stop on your first attempt, turn the capsule in itsholder and replace in blister until blinking stops.4. To verify that the capsule is operating, hold it in front ofthe patient’s abdomen, close to the sensors.
Capsule EndoscopyGiven Imaging Ltd. 85The Data Recorder LED starts blinking in green.5. Instruct the patient to take the M2A™ Capsule out of itsholder.6. Ask the patient to put the M2A™ Capsule in his/hermouth, and to hold it under the tongue WITHOUTINGESTING.7. If after a short adjustment period, with the M2A™Capsule in the patient’s mouth, the green light keeps onblinking, ask the patient to ingest the capsule with a sipof water.Note:The time elapsed between capsule activation andingestion should usually not exceed 1 minutes.8. In the Event Form, write down the ingestion time of theM2A™ Capsule.
Capsule EndoscopyGiven Imaging Ltd. 86Discharging the PatientOnce the patient has ingested the M2A™ Capsule, the patientmay leave the clinic. The examination lasts as long as theData Recorder LED is blinking but not less than 6 hoursunless the M2A™ Capsule was excreted. Verify that thepatient knows how to behave during the examination.! To discharge the patient1. Verify that the patient has the Patient Instructions forUndergoing Capsule Endoscopy, and a CapsuleEndoscopy Event Form.2. Verify that the patient knows how to behave during theexamination:• The patient should avoid any physical activitythat involves sweating, bending or stooping.• The patient should avoid any source of powerfulelectromagnetic fields such as one created near anMRI device• The patient needs to abstain food for another 2 hoursafter capsule ingestion. After 2 hours the patient maydrink water. Four hours after ingesting the capsule,the patient may eat a light snack.• The patient may take usual prescribed medication2 hours after ingesting the capsule.• The patient must not remove the Data RecorderWaist Belt until 8 hours after the procedure hasbegun.
Capsule EndoscopyGiven Imaging Ltd. 873. Ask the patient to check that the green LED of the DataRecorder is blinking. If it stops blinking, the patientshould write down the time the patient noticed it. If it isless than 6 hours since the ingestion of the Capsule, thepatient should immediately call your office.4. Ask the patient to return to the clinic with the DataRecorder, belt and Sensor Array after approximately 8hours.5. Instruct the patient whether, at the end of theexamination, he/she should take off the Data Recorderand Sensor Array by him/her self or should return to theclinic for removing the equipment.6. If the patient should take off the Recorder and SensorArray by him/her self, verify that the patient understandsthe instructions provided in the Patient Instructions forUndergoing Capsule Endoscopy.7. Discharge the patient.Receiving the Examination SetAt the end of the examination, the patient should return toyour clinic and you may take off the examination set unlessthe patient has already done this.It is recommended to recharge the Battery Pack immediatelyafter return.Note:
Capsule EndoscopyGiven Imaging Ltd. 88The Battery Pack should be charged only with the chargersupplied by Given® Diagnostic Imaging System.After removing the sensors from the adhesive sleeves, cleanthem before storing.! To receive the examination set1. Disconnect the Data Recorder from the Battery Pack.2. Take the Data Recorder and the Battery Pack out of thebelt.Recharge the Battery Pack. For instructions refer toCharging the Battery Pack on page 88.3. Carefully remove adhesive sleeves from sensors. Thiscan be done easily by tearing them in the middle alongthe perforation.4. To clean the Sensor Array, wipe it lavishly with 90%alcohol and let it air-dry for 20 minutes.5. When the Sensor Array is dry, return it to the CarryingCase in which they were supplied.6. To download the data from the Data Recorder, refer toCreating a PRR Movie on pate 46.Charging the Battery PackUse only a fully charged Battery Pack. Since even fullycharged batteries discharge slowly, recharge the Battery Pack
Capsule EndoscopyGiven Imaging Ltd. 89just before use. If a patient returns a Battery Pack at the endof an examination and on the following day anotherexamination will take place, immediately recharge theBattery Pack. Recharging a Battery Pack is an overnightprocess.Note:The rechargeable Battery Pack lasts at least 2 years. After twoyears of daily use or after 500 rechargings, it is recommended toreplace it.Warning: For charging the Battery Pack use only the Charger suppliedwith the Given® Diagnostic Imaging System! To recharge the Battery Pack1. Connect the Charger male 9-pin connector to the BatteryPack 9-pin Female connector.2. Connect the Charger to the electric socket.The Charger indicator is on.When the Charger indicator blinks, the Battery Pack isfully charged.3. Unplug the Charger from the socket and from the BatteryPack.
Capsule EndoscopyGiven Imaging Ltd. 904. Use the charged Battery Pack.
TroubleshootingGIven Imaging Ltd.91TroubleshootingTroubleshootingTroubleshootingTroubleshootingThis section describes common problems you may encounterwhen performing the Capsule Endoscopy, and instructs youon how to cope and overcome these problems.Note:If you encountered a problem that is not mentioned in this section,or you followed each step as advised in this section and theproblem persists, call Given® Imaging Limited technical supportTel: +972-4-909-7706 .Electrical OutagePROBLEMAn electrical outage occurred during patient Check-In,Recorder Initialization, or during download.SOLUTIONOnce electrical power has returned, restart the process.
TroubleshootingGiven Imaging Ltd. 92Data RecorderThe following section describes common problems youmight encounter while using the Data Recorder during theCapsule Endoscopy.Recorder InitializationPROBLEMDuring the Check-In process, after clicking Check-In, themessage Initializing Recorder stays on and the messageInitialization is complete does not appear.SOLUTION• Check the Connection Box connection to the mains andverify that the Connection Box LED is on.• Check the Recorder data directory:• Verify that the Recorder data directory is E:\rdata.• Verify that the \rdata directory is a shared directory.Use Windows Explorer or My computer to do that.If it is not a shared directory, select the E:\rdatadirectory, right-click it and use the sharing sub-menu.• Check the Connection Box-Workstation connection:• Verify that the LAN cable is properly connected.• Check the connection of the 9-pin female-female cableto the Workstation and to the Connection Box.• Verify computer name:
TroubleshootingGiven Imaging Ltd. 93My computer\properties\Network Identification\Fullcomputer name=RAPID. If not, change to RAPID andrestart the computer.Data Recorder OperationTo check the Data Recorder operation, always verify that theData Recorder LED blinks as soon as you connect it to theBattery Pack in the following blinking sequence:The Data Recorder green LED blinks, turns on and then off.Once the recording starts the LED blinks at the receiving rate.PROBLEM #1The LED of the Data Recorder does not blink uponconnecting the Battery Pack to the Data Recorder.SOLUTION• Change the Battery Pack. If the problem persists:• Change the Data Recorder and repeat the RecorderInitialization process.• Call technical support to report the faulty DataRecorder.
TroubleshootingGiven Imaging Ltd. 94PROBLEM # 2The Data Recorder LED does not blink while the M2A™Capsule is held near the Sensor Array.SOLUTION1. Move the M2A™ Capsule away from the Sensor Array.2. Disconnect the Battery Pack from the Data Recorder andthen reconnect them.3. Verify that the Data Recorder LED blinks and then turnsoff.If it blinks and then turns off, bring the M2A™Capsule close to the Sensor Array.If the Data Recorder LED blinks, you mayproceed with the procedure of dispensing theM2A™ Capsule.If the Data Recorder LED does not blink, useanother M2A™ Capsule. Be sure to dispose of thefirst capsule as per the instructions in thismanual.If the Data Recorder LED does not blink, change theBattery Pack.If the Data Recorder LED blinks upon BatteryPack connection, you may proceed with theprocedure of dispensing the M2A™ Capsule.If the problem persists:• Change the Data Recorder and repeat theRecorder Initialization process.
TroubleshootingGiven Imaging Ltd. 95• Call technical support to report the faulty DatarecorderPROBLEM #3Data Recorder LED does not blink when the M2A™ Capsuleis in the patient’s mouth.SOLUTION1. Tell the patient to keep the Data Record belt on, andinstruct the patient to take the M2A™ Capsule out ofhis/her mouth.2. Hold the M2A™ Capsule next to a sensor attached to thepatient’s abdomen.If the LED blinks, ask the patient to ingest the Capsule.If not, replace the M2A™ Capsule and restart theM2A™ Capsule Dispensing procedure as described onpage 84. Be sure to dispose of the first capsule as perthe instructions in this manual.PROBLEM #4The Data Recorder LED stops blinking during theexamination and more than 6 hours have passed since theCapsule ingestion.SOLUTIONA minimum of 6 hours is considered a successfulexamination. However, it is recommended to try and continuewith the examination, and to check that the termination is notdue to a connection fault or to a Battery Pack premature
TroubleshootingGiven Imaging Ltd. 96depletion. (However, the belt must be worn in any event for aminimum of 8 hours.). To check the connection and theBattery Pack, perform the following:• Battery Pack and Data Recorder ConnectionIf there is a problem with the connection,1. Reconnect the Battery Pack to the Recorder2. Verify the blinking sequence of the DataRecorder LED:If the LED blinks upon Battery Pack connectionand then blinks according to the rate ofrecording, continue with the examination.If the LED does not blink upon connection of theBattery Pack,, refer to Data Recorder Problem #1.If the LED blinks upon Battery Pack connectionbut does not start blinking according to the rateof recording with an active capsule, the capsule’sbattery is depleted. Consider completing theexamination.If the connection is intact,1. Change Battery Pack.2. Verify the Data Recorder LED blinkingsequence:If the LED blinks according to the sequenceproceed with the examination.If the LED blinks upon Battery Pack connectionbut does not start blinking according to the rateof recording with an active capsule, the capsule’s
TroubleshootingGiven Imaging Ltd. 97battery is depleted. Consider completing theexamination.If the LED does not blink upon Battery Packconnection according to the blinking sequence,refer to Data Recorder Problem #1.PROBLEM #5The Data Recorder LED stops blinking during theexamination and less than 6 hours have passed since theCapsule ingestion.SOLUTION• Tell the patient to keep the Data Record belt on, and heckthe Battery Pack-Data Recorder connection.If there is a problem with the connection:1. Reconnect.2. Verify the blinking sequence of the Data RecorderLED:If the LED blinks upon Battery Pack connectionand then blinks according to the rate ofrecording, continue with the examination.If the LED blinks upon Battery Pack connectionbut does not blink when receiving data, theM2A™ Capsule is defective.Reschedule for another examination at a differentdate after excretion of the M2A™ Capsule.
TroubleshootingGiven Imaging Ltd. 98If the LED does not blink upon Battery Packconnection, refer to Data Recorder Problem #1. Ifproblem persists, reschedule for another examinationat a different date after excretion of the M2A™Capsule, and contact Given® Imaging Limitedtechnical support.If connection is intact:1. Change Battery Pack.2. Check blinking sequence of the Data Recorder LED:If the blinking sequence is correct, proceed withthe examination and discharge the patient.If the LED blinks, turns on and then off, but doesnot blink according to the receiving rate,reschedule for another examination at a differentdate after excretion of the M2A™ Capsule.If the LED does not blink upon Battery Packconnection, refer to Data Recorder Problem #1. Ifproblem persists, reschedule for another examinationat a different date after excretion of the M2A™Capsule, and contact Given® Imaging Limitedtechnical support.
TroubleshootingGiven Imaging Ltd. 99Data Recorder DownloadPROBLEMThe download does not start and the Please Wait messageconstantly appears.SOLUTION• Check the connection of the Connection Box to theelectric socket and verify that the Connection Box LED ison.• Check Data Recorder directory:• Verify that the Data Recorder directory is \rdata.• Verify that the \rdata directory is a shared directory.Use Windows Explorer or My computer.• Check the Connection Box-Workstation connection:• Verify that the LAN cable is properly connected.• Check the connection of the 9-pin female cable tothe Workstation and to the Connection Box.• If all above are OK and the problem persists, callGiven® Diagnostic Imaging System technicalsupport.
TroubleshootingGiven Imaging Ltd. 100Sensor ArraySensor Array ConditionPROBLEMThe Sensor Array you use is worn or torn.SOLUTIONUse another Sensor Array supplied by Given® ImagingLimited. Do not use a torn or a worn Sensor Array.Sensor LocationPROBLEMYou applied a sensor to the wrong location.SOLUTION1. Remove the sensor from its location.2. Carefully, take the sensor out of the adhesive sleeve.3. Insert the sensor in a new adhesive sleeve.4. To secure the sensor in the adhesive sleeve, remove theliner from the adhesive area at the opening of theadhesive sleeve and press the two lips together.5. Reapply to correct location.
TroubleshootingGiven Imaging Ltd. 101M2A™ CapsulePROBLEMThe M2A™ Capsule does not blink when removed from itsblister.SOLUTIONReplace the M2A™ Capsule with another M2A™ Capsule,and discard the defective capsule.
TroubleshootingGiven Imaging Ltd. 102
IndexGIven Imaging Ltd. 103IndexAAdd New Patient window, 42AVI movie, 64Ccapturing a frame, 59capturing thumbnail, 53changing display settings, 31checking in a patient, 41commentediting, 66reading, 65connecting the Recorder, 48Control Buttons, 40, 52creating a movie, 46DData Recorder Directory, 46Defining Data Recorder and PatientRAPID Report, 46disconnecting the Recorder, 41downloading, 48Eediting a comment, 66FFile menu, 37frame, 56, 59capturing, 59moving by, 56Ggastrointestinal tract, 1, 2, 3, 35Iinitializing the Recorder, 41MM2A™, 41Main Screen, 36, 50menus, 36Title Bar, 36movie, 56, 58, 67Control Buttons, 40creating, 46file name, 50
TroubleshootingGiven Imaging Ltd. 104moving from repruduction to, 67pausing, 58presentation, 52restart, 56selecting, 50speed, 53, 54, 55time indication, 57movie file name, 50movie speed, 52OOnline menu, 39Options window, 31, 39, 47, 54Ppatient registration, 41QQuitting the RAPID™ Application,37RRAPID™, 29, 31Main Screen, 31, 35running, 29selecting a language, 29reading a comment, 65Recorder Download window, 48removing a thumbnail, 65Ssaving a group of thumbnails, 64saving a thumbnail, 63scrolling through thumbnails, 62selecting a language, 29selecting a movie, 46, 50selecting a thumbnail, 61small intestine, 1Tthumbnail, 61thumbnailmoving from, 67removing, 65saving, 63saving a group of, 64scrolling through, 62selecting, 61Thumbnail section, 40, 59, 60, 65,66, 67Timebar, 40, 52, 57, 59, 68, 69Title Bar, 50Tools menu, 39Vvideo, 52Video menu, 38Video section, 40, 51, 52Video speed, 53Wwatching the movie, 52WindowAdd New Patient, 42Options, 30, 31, 39, 47, 54Recorder Download, 48

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