Given® Diagnostic Imaging System User’s Manual DRAFT
Given® Diagnostic Imaging System User’s Manual COPYRIGHT This manual is the property of Given® Imaging Limited. and may not be transferred or reproduced in any form without the written permission of Given® Imaging Limited. This manual is protected under the copyright laws of Israel. Copyright © 2001, Given® Imaging Limited. All rights reserved. TRADEMARKS The RAPID™ Application and the M2A™ Capsule are trademarks of Given® Imaging Limited. Given® is a registered trademark of Given® Imaging Limited.
Table of Contents Table of Contents CHAPTER ONE ............................................................................................... 1 GIVEN® DIAGNOSTIC IMAGING SYSTEM...................................................... 1 System Overview........................................................................................ 1 M2A™ Capsule...................................................................................... 3 Data Recorder Set....................................................
Contents CHAPTER THREE........................................................................................ 28 GETTING TO KNOW RAPID™ .................................................................... 28 Running the RAPID™ Application.......................................................... 28 Selecting a Language............................................................................ 29 Changing Display Settings ...................................................................
Contents Saving a Group of Thumbnails......................................................... 64 Removing a Thumbnail .................................................................... 65 Creating or Editing a Comment........................................................ 65 Reading the Comment ...................................................................... 66 Moving from a Thumbnail to the Movie.......................................... 67 Timebar................................................
Contents Given Imaging Ltd.
Chapter One Given® Diagnostic Imaging System System Overview The Given® Diagnostic Imaging System is an easy-to-use non-invasive and ambulatory device that permits visualization of the patient’s gastrointestinal tract, especially the small intestine. The system is comprised of three main components: • M2A™ Capsule • Data Recorder Set • RAPID™ Application Software and Workstation Given Imaging Ltd.
Overview RAPID™ Workstation Waist Belt Data Recorder Sensor Array M2A™ Capsule The M2A™ Capsule acquires pictures of the gastrointestinal tract and transmits them to the Data Recorder. The Data Recorder stores the pictures and downloads the data to the RAPID™ Workstation. On the workstation, the data is processed into a colorful, easy-to-control Patient RAPID™ Report (PRR) video movie. You can view the PRR movie to analyze and make diagnoses about any abnormalities in the gastrointestinal tract.
Overview M2A™ Capsule The ingestible imaging M2A™ Capsule acquires video images while traveling along the patient’s gastrointestinal tract. The M2A™ Capsule is propelled by peristalsis through the gastrointestinal tract and does not require a pushing force to propel it through the bowel. The M2A™ Capsule contains a miniscule color video camera with a flash (CMOS Imager), a watch battery, a transmitter, and an antenna, all of which are embedded within a regular size ingestible capsule.
Overview The M2A™ Capsule starts immediately after its removal from the proximity of the magnet in the blister and the consequent closing of the magnetic switch in the capsule. After a brief (less than one minute) test by the physician to verify that the capsule is active, the capsule is ingested by the patient. While active, the capsule transmits images at a rate of 2 images per second. For each image, an illuminating light flash of 100ms is applied with the illuminating LEDs.
Overview Data Recorder Set The Data Recorder Set includes the following items: • Data Recorder • Sensor Array • Battery Pack • Waist Belt • Battery Charger Data Recorder The Data Recorder is an external receiving/recording unit that receives the data transmitted by the M2A™ Capsule. The Data Recorder is a portable Walkman™-size batteryoperated unit attached to a waist belt worn by the patient during the examination.
Overview Sensor Array The Sensor Array receives data from the M2A™ Capsule and transfers it to the Data Recorder. It is comprised of 8 identical sensors. Each sensor is connected to the Data Recorder module by a flexible coaxial cable. The sensor is built of flexible printed circuit board (PCB) and is attached to the skin by means of disposable, medical adhesive pads. Battery Pack The Battery Pack is the power supply of the Data Recorder. It includes 8 Nickel-metal 6V rechargeable batteries.
Overview Sensor Array Sensor Array cable Battery Pack Data Recorder M2A™ Capsule with holder M2A™ Capsule For specification and technical parameters of the Data Recorder, refer to System Specifications on page 15. Given Imaging Ltd.
Overview RAPID™ Application Software and Workstaion The RAPID™ Workstation is a modified standard personal computer designed for storage, presentation and processing of the acquired images and for generating reports.
Overview Indications and Contraindications Indications The Given® Diagnostic Imaging System is intended for the detection of pathologies as an adjunctive tool in the diagnosis of small bowel gastrointestinal disorders and diseases. The Given® Diagnostic Imaging System may be used in hospitals, outpatient clinics and physician offices. After the M2A™ Capsule is ingested the patient is not restricted to a medical environment.
Overview Warnings A Warning indicates a condition that may endanger the patient or the operator. Warnings • The M2A™ Capsule should be used only after consulting a physician. • A thorough understanding of the technical principles, clinical applications and risks associated with the Given® Diagnostic Imaging System is necessary before using this product. Read the entire manual before using the system for the first time.
Overview • The patient should be instructed to contact the physician immediately if after ingesting the M2A™ Capsule he/she has any abdominal pain, nausea or vomiting. • The patient should be instructed to keep the Data Recorder Waist Belt on throughout the procedure, for a minimum of 8 hours. • This M2A™ Capsule must be stored in a safe place out of the reach of children and/or infants.
Overview Precautions A precaution indicates a condition that may damage the equipment. Precautions • USA Federal law restricts this device to sale by or on the order of a physician. • Make sure that only trained personnel familiar with all of the Given® Diagnostic Imaging System operating procedures use the system. • Use the system only with components purchased from Given® Imaging Ltd. Use of other components can void the system’s warranty and may damage it.
Overview Adverse Events In patients with strictures of the gastrointestinal tract, the M2A™ Capsule can potentially cause intestinal obstruction resulting in the need for hospitalization and surgery. The use of the M2A™ Capsule in patients with strictures of the gastrointestinal tract is contraindicated. Based on the experience gained so far, there is no adverse event related to the proper use of the Given® Diagnostic Imaging System. Given Imaging Ltd.
Overview System Labeling The following table lists the labels attached to various components of the Given® Diagnostic Imaging System. Labeling Explanation The M2A™ Capsule should be stored and used at a distance from any powerful magnetic fields such as the one created by an MRI. The M2A™ Capsule is intended for single use only. 2 Attention! Consult the documentation provided with the Given® Diagnostic Imaging System. ! Class II equipment Type BF equipment FCC compliance . Given Imaging Ltd.
Overview System Specifications Note: Specifications are subject to change without prior notice and without any obligation to users on the part of the manufacturer. M2A™ Capsule Properties Physical Optical Operational Dimensions Length: 26mm Diameter: 11mm Weight 3.7 gr Material Illumination Biocompatible plastic 4 white light emitting diodes Field of View 1400 Effective Visibility Distance: 3 cm Magnification 1:8 Min. Detectable Object Less than 0.
Overview Data Recorder Software Proprietary firmware Recording time Up to 10 hours Weight 305 gr Battery type External, nickel-metal, 6V, 6500mAH Battery Pack weight 912gr Sensor Array 8 flat 40 mm diameter flexible PCB Operating Temperature 5 - 50C0 Storage Temperature -40 - 70C0 Shielding Shiledex® Supra, from Less EMF Inc.
Overview About this Manual This manual guides you through the use of the Given® Diagnostic Imaging System. It instructs you on how to connect, 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 and this Manual. Chapter 2: System Setup – instructs you on how to set up the Given® Diagnostic Imaging System.
Overview Conventions Menu, dialog box, tab and button names and options are bolded and begin with uppercase letters. For example: Click Save or select the Save All option. Convention Explanation Keyboard keys File > Open Open the File menu and select the Open option. An important note Bulleted List A one step procedure or a list of items. • Click Open. Numbered List A multistep procedure. You need to perform the procedure step by step according to the order of the steps.
Overview Contacting Given® Imaging Information and Technical support for the RAPID™ Application and other system components is available from: Company Headquarters Europe Given Imaging Limited POB 258 Yokneam, Israel 20682 Tel: +972-4-909-7777 Fax: +972-4-959-2466 info@givenimaging.com North America Australia & New Zealand Given Imaging Inc. Oakbrook Technology Center 5555 Oakbrook Parkway, # 355 Norcross, GA 30093 Tel: 770-662-0870 1-800-GIVENGI Fax: 770-662-0510 infousa@givenimaging.
Chapter Two System Setup Before Your System Arrives Before the Given® Diagnostic Imaging System arrives in your clinic prepare the following: • Five outlets: an outlet for the computer, monitor, power supply, 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 Box and its wiring (about 8-12 inches, 20-30 cm) and for the Data Recorder.
System Setup Connecting the System This section describes the various connectors and cables of the Given® Diagnostic Imaging System and instructs you on how to connect the system.
System Setup Connecting the Workstation Use the back panel of the workstation for connecting the monitor, keyboard, mouse, printer, LAN cable, modem, and the Connection Box according to the scheme below: Monitor Backpanel Printer Backpanel Telephone Line Workstation Backpanel Parallel/Printer Port Serial (com) Port 2 Monitor LAN Modem Network Socket Serial (com) Port 1 USB 2 Mouse Given Imaging Ltd.
System Setup The following table lists the connectors of the Workstation back panel: Connector Explanation Power 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 to Parallel Port.
System Setup ! To connect the workstation 1. 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 a standard LAN cable 4. Connect the Monitor cable to the Monitor connector. 5. Insert the Modem cable to the Modem connector and the other jack phone connector of the Modem cable to the phone outlet. 6.
System Setup Connecting the Connection Box The Connection Box connects between the Workstation and the Data Recorder. Workstation Backpanel Parallel/Printer Port Serial (com) Port 2 Power Supply Monitor LAN Modem Network Socket USB Serial (com) Port 1 2 Network Cable 9 Pin Fe male-Female Connection Box Mouse Keyboard The following table lists the connectors and indicators of the Connection Box.
System Setup ! To connect the Connection Box 1. Connect the 9-pin Male connector of the Connection Box to the serial Com 1 of the Workstation with the 9-pin Female-Female connection cable. 2. Connect the LAN cable to the LAN connector of the Connection 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.
Given® Diagnostic Imaging System User’s Manual System Setup Scheme Once you have finished connecting the Given® Diagnostic Imaging System, use the following figure to verify the various connections.
Chapter Three Getting to Know RAPID™ Running the RAPID™ Application The RAPID™ Application software complies with the conventions of Windows® operating system applications conventions. However, various functions of the Windows operating system are disables or modified to enable the proper function of the RAPID™ Application.. During its operation, the RAPID™ Application writes files and reads files from pre-defined locations on the RAPID™ Workstation hard disks.
RAPID™ Application while 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 images as files, use the “User” subdirectory. To copy files from the RAPID™ Workstation use only the “User” subdirectory. Running the RAPID™ Application is very easy and simple.
RAPID™ Application The Options window appears: Click here to select a language E:\rdata E:\trials Automatic 2. Open the Language drop-down list and select the desired language. 3. Click OK. 4. Select File > Exit option to close the application. 5. Double click the RAPID™ Application icon to re-run the program. The RAPID™ Application is running with the language of your choice. Changing Display Settings The RAPID™ Application is supplied with a default Automatic display setting.
RAPID™ Application Application 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 to restart the RAPID™ Application. ! To apply specific display settings 1. Select Tools > Option. The Options window appears. Click here to select display settings E:\rdata E:\trials Automatic 2.
RAPID™ Application 5. Double click the RAPID™ Application icon. Changing the Units You can set the unit of measure for the measurements that you type in dialog boxes. By default, the RAPID™ Application is using centimeters and kilograms. You can set the unit of measure to inches and pound. ! To change the unit of measure 1. Select Tools > Options. The Options window appears: Click here to select the unit of measure E:\rdata E:\trials Automatic Given Imaging Ltd.
RAPID™ Application 2. Open the Measurement System drop-down list and select the desired measurement system. 3. Click OK. The RAPID™ Application is running with the unit of measure of your choice. Main Screen The RAPID™ Main Screen enables you to watch the PRR movies and to diagnose irregularities in the gastrointestinal tract. The following sections introduce you to the various sections of the RAPID™ Main Screen and guide you through the various available menu options.
RAPID™ Application The RAPID™ Main screen is comprised of the following sections: • Title bar • Menu section. • Video section • Thumbnail section • Timebar section Given Imaging Ltd.
RAPID™ Application Title Bar The title bar displays the patient ID, initials and test date. You entered these details during the Check-In process and they were derived from the recorder during download. Main Screen Menus The drop-down menus of the RAPID™ Main Screen enable you to use the various options available through the menus. The following tables list the various menus and their options. Given Imaging Ltd.
RAPID™ Application File Menu The File menu enables you to open or to save the PRR movies and groups of thumbnails and to quit the RAPID™ Application. Option Explanation Open Enables you to select a PRR movie of previous examinations. Save Video As Saves the video under a different file name. However, while watching the movie, the name of the movie as derived from the recorder appears in the Title bar. Open Thumbnail Opens a selected file of thumbnails.
RAPID™ Application Video Menu The Video menu enables you to control the PRR movie. Option Explanation Step 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 a specific time indication.
RAPID™ Application Online Menu The Online menu enables you to check in a patient and to download and construct a PRR movie. Option Explanation Patient Check-In Opens the Recorder Initialization screen. Recorder Download Opens the Recorder Download screen. Service This option is enabled only for an authorized Given® technician. Tools The Tools menu allows you to change the RAPID™ Application interface and to set the source and target path prior to the download.
RAPID™ Application Video Section The Video section includes the presentation area and the Control Buttons. The Control Buttons are located at the bottom of the Video section and they allow you to do the following: • 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 frame that is currently projected, as derived from the Recorder.
RAPID™ Application presented in the Video section. In addition it presents the time of any thumbnail. For further information, refer to Timebar on page 68. Given Imaging Ltd.
RAPID™ Application Patient Check-In The RAPID™ Application enables you to check in the patient who is intending to undergo the Capsule Endoscopy. The checking in process includes the following: • Patient Registration – filling in the Registration computerized form. • Recorder Initialization – downloading patient details to the Recorder. • Disconnecting the Recorder. ! To check in a patient 1. Select Online > Patient Check-In. The following screen appears guiding you through connecting the Recorder.
RAPID™ Application 2. Follow the instructions on the Recorder Initialization screen: Verify that the Connection Box is connected to the computer. Verify that the power supply is connected to the electric socket. Verify that the Connection Box is connected to the power supply. Verify that the Recorder is NOT connected to the Connection Box. Note: Connect the Recorder to the Connection Box only when instructed to do so. 3. Click Yes. The Add New Patient window appears. Given Imaging Ltd.
RAPID™ Application Enter patient’s details Enter protocol number and date of test Messages area Click to initialize the Recorder Click to cancel 4. 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 clinical protocol. Given Imaging Ltd.
RAPID™ Application 6. Open the Gender drop-down list and select the required gender. 7. Under Birth Date, click the arrow and select the required date of birth. 8. Open the Physique drop-down list and select either skinny, normal, stocky or potbelly. Use the following figure: skinny normal stocky potbellied 9. Under Protocol Number, enter the code of the clinical trial protocol, you have been assigned by Given® Imaging Limited, Division of Medical Affairs. 10.
RAPID™ Application Recorder cable to the 9-pin Male connector of the Data Recorder. In the Message area, a message appears notifying you that the Recorder initialization starts. The details you entered during the patient registration are saved in the Data Recorder directory and are downloaded to the Data Recorder. Upon completion, a message appears notifying you that the Data Recorder initialization is complete.
RAPID™ Application Creating a Movie Once you open the RAPID™ Application Main Screen and you wish to watch a PRR movie, perform either one of the following: • Create a movie. • Select and watch an existing movie. Creating a PRR Movie To create a movie, you need to download raw data from the Recorder to the workstation. This process is comprised of two stages: • Defining Data Recorder and Patient RAPID Report directories. • Connecting the Recorder to the workstation.
RAPID™ Application ! To define the directories 1. Select Tools > Options. The Options window appears: Define here a directory Click to modify the default Input or Output path E:\rdata E:\trials Define here a directory Automatic 2. The default Recorder Data directory is: E:\ rdata. You should not change this setting unless instructed so by Given® Imaging technical support. To change the setting, click Modify and define the path of your choice. 3. The default Patient RAPID Report is: E:\trials.
RAPID™ Application Note: The Data Recorder requires a shared \rdata directory in order to be able to download data to the workstation. This directory should not be modified unless under instructions from Given® Imaging technical support. Connecting the Recorder and Downloading Once you have defined directories for saving the downloaded and the processed data, you can connect the Recorder and download the raw data. The RAPID™ Application guides you on how to connect the Recorder to the workstation.
RAPID™ Application 2. Follow the instructions that appear on the Recorder Download screen: • Verify that the Connection Box is connected to the computer. • Verify that the power supply is connected to the electric socket and to the Connection Box. • Verify that the Recorder in NOT connected to the Connection Box. 3. Verify that all files in the Recorder data directory path can be deleted. If they cannot be deleted, click Cancel and re-define a shared \rdata Recorder data directory path.
RAPID™ Application PRR Movie Name Once the download process is complete, a new PRR movie appears in the Output path you have defined. The movie file name is comprised of the following components separated by an underscore. The components are derived from the Recorder 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.
RAPID™ Application If you saved a movie under a different name, once you open the file and watch the movie, the Title bar of the RAPID™ Main Screen displays the original movie name. ! To select a movie 1. In the RAPID™ Main Screen, select File > Open. The Open window appears indicating the default directory of the PRR movies. 2. The default directory of the PRR movie appears. If you stored the video in another location, navigate to the desired location. 3. Select the desired movie (*.
RAPID™ Application Watching the PRR Movie The Video section enables you to watch the video captured by the M2A™ Capsule during the examination. The PRR movie is comprised of a series of single images and it can present from 1 to 25 frames per second according to the selected movie speed. Primary Screening of the Movie A primary screening of the movie is available while watching the movie in Automatic speed mode.
RAPID™ Application Button Action Video speed Selects the projection rate. The available rates are Automatic, Slow and Fast. The Video Speed button changes according to the selected speed. Restart Restarts the movie. Back Step Moves back to the previous frame. Play backward Plays the movie backward. If you click the Play backward button, the Play forward button changes to the Pause button while the movie is playing. Plays the movie forward.
RAPID™ Application Step Moves to the last frame of the movie. End Duplicates a frame. The duplication immediately appears in the Thumbnail section. Capture Thumbnail Selecting the PRR Movie Speed There 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 5 frames per second) according to the rate of change in successive images.
RAPID™ Application Setting the Fast and Slow Speed Rate By default the fast speed is 10 frames per second and the slow speed is 5 frames per second. The Options window allows you to change the default settings of the Fast and Slow modes. ! To change the default settings of Fast and Slow modes 1. Select Tools > Options. 2. The Options window appears. Set the desired speed for the Slow mode Set the desired speed for the Fast mode 3. Under Slow select the desired speed rate for the Slow mode. 4.
RAPID™ Application Restarting the Movie When you restart the movie, the time and frame indications are automatically updated along with the Timebar. ! To restart the movie • Click the Restart button. The PRR movie starts from the beginning and the related features such as the Time and Frame indications at the bottom of the Video section automatically resets to zero. Moving by Frames You can move along the movie one frame forward or backward, or to the last frame.
RAPID™ Application • To move to the last frame in the PRR movie, click the End button. The movie moves to the last frame and the time indication at the bottom of the Video section representing the end of the study, is automatically updated. Moving by Time Indication You can move to a certain section of the movie by indicating a time unit in the Time text box at the bottom of the Video section. The movie automatically moves to the related section of the movie. ! To move by time indication 1.
RAPID™ Application Playing and Pausing When you watch the movie and you would like to have a longer look at one of the frames, you can temporarily stop the projection of the movie. ! To Play/Pause the PRR Movie To play the movie, click the Play forward button. The movie is on. The Play backward button changes to the Pause button. To play the movie, click the Play backward button. The movie is on. The Play forward button changes to the Pause button. To pause the movie, click the Play button.
RAPID™ Application Capturing an Image When you capture a frame the following occurs: • The captured frame immediately appears at the bottom of the Thumbnail section. The time indication derived from the Recorder appears next to the captured frame in the Thumbnail section. • An indication of the thumbnail appears in the Timebar section of the RAPID™ Main screen. ! To capture a frame 1. 1. While the movie is playing, click Pause. 2. While the movie is still, click Capture Picture.
RAPID™ Application Thumbnail Section The Thumbnail section displays images captured from the PRR movie. Each reproduction appears in the Thumbnail section with a time indication derived from the Recorder and the first few words of the attached comment. A picture captured from the movie Drag the scroll bar to scroll through the thumbnails Time indication derived Once youfrom havethecaptured three images, a scroll bar appears Recorder along the right side of the Thumbnail section.
RAPID™ Application ! To select several thumbnails 1. Select a thumbnail. 2. Move the mouse pointer to another frame you wish to select and simultaneously click the mouse and the key of your keyboard; both selected thumbnails are covered by a blue square. 3. Repeat step 2 until you selected all the desired pictures. Given Imaging Ltd.
RAPID™ Application ! To select all thumbnails 1. Select the thumbnail at the top of the Thumbnail section. 2. Scroll to the last thumbnail and simultaneously click the mouse and the key of your keyboard; all thumbnails are selected. Scrolling through the Thumbnails To scroll through the thumbnails, use the scroll bar located on the right side of the Thumbnail section. The thumbnails are arranged according to the sequence of capturing.
RAPID™ Application Saving a Thumbnail When you save a thumbnail, you actually save the thumbnail AND a short movie. The movie is comprised of 100 adjacent frames, 50 frames before and 50 frames after the selected frame. To watch this short movie, use any Windows media player, which is already installed on the Workstation. The thumbnail is saved as a JPEG file and the short movie as an AVI file. You need to select only the location for saving the thumbnail.
RAPID™ Application The thumbnail is stored in the location of your choice as a JPEG and an AVI file, and a message appears notifying you that the operation is complete. ! To watch a the AVI movie 1. Open the Windows media player. 2. Navigate to the *.avi file of the thumbnail you wish to examine. 3. Select the file. 4. Click OK. The short movie of 100 images is running. Saving a Group of Thumbnails You can save a group of thumbnails as an independent file.
RAPID™ Application Removing a Thumbnail 1. 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 the Thumbnail section. Creating or Editing a Comment If you want to annotate a Thumbnail by entering a comment or to edit a comment, do the following: ! To edit a comment 1. In the Thumbnail section, select a thumbnail. 2. Click the right mouse button; a menu appears. 3. Select Comment.
RAPID™ Application 5. Click OK to save the changes and to close the Comment window. Reading the Comment In the Thumbnail section, you can read the annotating comment of a thumbnail by placing the pointer of the mouse on the beginning of the comment that appears below the thumbnail. Move the mouse pointer to here to view the complete comment Given Imaging Ltd.
RAPID™ Application ! To read the comment • Position the mouse pointer on the first word of the comment located under the thumbnail. The full comment appears and you can read it. Moving from a Thumbnail to the Movie If you wish to look at the images adjacent to the captured one, you can move from the Thumbnail section to the Video section. The PRR movie automatically displays the captured frame to enable you to look at what preceded or followed the captured frame.
Given® Diagnostic Imaging System User’s Manual Timebar The Timebar indicates the time as derived from the Recorder during the movie projection. The Timebar is synchronized with the movie and it moves along indicating the elapsed time by changing the moving bar into light blue.
RAPID™ Application Scrolling Through the Movie You can scroll through the movie by dragging the Timebar up or down. The movie presentation is updated accordingly. ! To scroll through the movie • Drag the gray area of the Timebar up, to view the first section of the movie and down to view the last section of the movie. The displayed PRR movie is updated accordingly.
Chapter Four Performing Capsule Endoscopy Once the Given® Diagnostic Imaging System is connected and ready for use and you are familiar with the system and the RAPID™ Application, you can perform a Capsule Endoscopy. 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.
Capsule Endoscopy Preparing the Patient Once you have decided that the patient should undergo the Capsule Endoscopy, inform the patient that the Capsule Endoscopy involves the following: • Ingesting a small (the size of a large vitamin pill) Given® Imaging M2A™ Capsule which will pass naturally through the patient’s digestive system while taking pictures of the intestine. • Attaching to the abdomen a Sensor Array. The images captured by the M2A™ Capsule are transmitted to the Sensor Array.
Capsule Endoscopy • After ingesting the M2A™ Capsule, the patient should immediately contact the physician’s office if he/she has any abdominal pain, nausea or vomiting. • After ingesting the M2A™ Capsule and until it is excreted, the patient should not be near any source of powerful electromagnetic fields such as one created near an MRI device • During the examination, the patient should avoid any strenuous physical activity. He/she should not bend or stoop during the Capsule Endoscopy.
Capsule Endoscopy Preparing Patient Examination Set Verify that the Given® Diagnostic System is set up according to the instructions provided in the Connecting the System on page 21, and that you have the following equipment and accessories: • 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).
Capsule Endoscopy • The \rdata directory is defined as the Data Recorder directory. • The RAPID™ Application is configured according to your convenience, i.e., the language, screen settings and measurement system. • The patient abstained from eating or drinking for the last 8 hours. • The patient did not take any medication in the last 2 hours. • The patient (if male) shaved the area of the abdomen 6 inches above and below the navel.
Capsule Endoscopy Adjusting the Recorder Battery Belt The Recorder-Battery belt is an external belt that the patient wears during the examination. It contains two pouches for holding the Recorder and the Battery pack. It is important that the belt fits the patient and the patient is comfortable wearing the belt. ! To fit the Recorder-Battery belt 1. Ask the patient to stand up. 2. Place the belt around the patient’s waist. 3. Adjust the belt to fit the patient.
Capsule Endoscopy Connecting Belt Components This section instructs you on how to connect the Battery Pack to the Recorder and how to secure both Battery Pack and the Data Recorder in their pouches. Note: Since fully charged batteries slowly discharge, use only a Battery Pack you have just charged. For information on how to charge the Battery Pack, refer to Charging the Battery Pack on page 88. ! To connect belt components 1. Place a recently fully charged Battery Pack in the battery belt pouch. 2.
Capsule Endoscopy 5. Use the Velcro straps to secure the Data Recorder and Battery Pack cable. 6. Fold the remaining length of the Battery Pack cable and secure it with the Velcro flap along the back of the belt. 7. Put the belt aside until the patient is ready to wear it. Warning Do not connect the Data Recorder to the RAPID™ Workstation while Data Recorder is connected to the Sensor Array that is worn by the patient or while the Waist Belt is in the belt being worn by the patient. Given Imaging Ltd.
Capsule Endoscopy Attaching the Sensor Array to the Patient The Sensor Array is attached to the patient’s abdomen. Use the Sensor Template to place each one to the eight sensors of the Sensor Array in its correct location. Given Imaging Ltd.
Capsule Endoscopy Necessary equipment and accessories The M2A™ Capsule 10-Pak of the Given® Diagnostic Imaging System also includes the Sensor Application kit. The kit contains the following items which are necessary for deploying the Sensor Array: Item Explanation Sensor Template Helps you position each one of the eight sensors in their proper location. Marker Enables to mark the location of each sensor.
Capsule Endoscopy The template has 9 holes. Eight holes indicate the recommended location of each one of the eight sensors and the additional hole indicates the navel as a reference point. Place the template on the patient’s abdomen and use the marker 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 with the adhesive sleeves. The adhesive sleeves are supplied with the Sensor Application kit.
Capsule Endoscopy 2. To secure the sensor in the sleeve, remove the liner from the adhesive line at the opening of the adhesive sleeve and press both lips together. 3. Ask the patient to lie down and to expose his/her stomach area down to the pubic bone. 4. If a male patient arrives unshaven, wipe the patient’s abdomen with disinfectant and shave the abdomen 6 inches above and below the umbilicus (navel). 5.
Capsule Endoscopy 10. To secure the Sensor Array cable to the left side of the patient’s body, use the remaining adhesive pads as the following scheme shows: 11. Instruct the patient to get dressed. The Sensor Array connector and approximately 10 inches of cable should remain outside of the patient’s clothes. Putting the Belt on the Patient Since you adjusted the belt, putting it on the patient is very quick and simple. ! To put the belt on the patient 1.
Capsule Endoscopy 3. Instruct the patient that the belt should not be removed during the course of the examination for any reason, at least 8 hours. Given Imaging Ltd.
Capsule Endoscopy Dispensing the M2A™ Capsule Before dispensing the capsule ascertain that there is no other M2A™ Capsule or other diagnostic capsule in the patient’s gastrointestinal 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™ Capsule 1. Prepare a glass of water for the patient. 2.
Capsule Endoscopy The Data Recorder LED starts blinking in green. 5. Instruct the patient to take the M2A™ Capsule out of its holder. 6. Ask the patient to put the M2A™ Capsule in his/her mouth, and to hold it under the tongue WITHOUT INGESTING. 7. If after a short adjustment period, with the M2A™ Capsule in the patient’s mouth, the green light keeps on blinking, ask the patient to ingest the capsule with a sip of water.
Capsule Endoscopy Discharging the Patient Once the patient has ingested the M2A™ Capsule, the patient may leave the clinic. The examination lasts as long as the Data Recorder LED is blinking but not less than 6 hours unless the M2A™ Capsule was excreted. Verify that the patient knows how to behave during the examination. ! To discharge the patient 1. Verify that the patient has the Patient Instructions for Undergoing Capsule Endoscopy, and a Capsule Endoscopy Event Form. 2.
Capsule Endoscopy 3. Ask the patient to check that the green LED of the Data Recorder is blinking. If it stops blinking, the patient should write down the time the patient noticed it. If it is less than 6 hours since the ingestion of the Capsule, the patient should immediately call your office. 4. Ask the patient to return to the clinic with the Data Recorder, belt and Sensor Array after approximately 8 hours. 5.
Capsule Endoscopy The Battery Pack should be charged only with the charger supplied by Given® Diagnostic Imaging System. After removing the sensors from the adhesive sleeves, clean them before storing. ! To receive the examination set 1. Disconnect the Data Recorder from the Battery Pack. 2. Take the Data Recorder and the Battery Pack out of the belt. Recharge the Battery Pack. For instructions refer to Charging the Battery Pack on page 88. 3. Carefully remove adhesive sleeves from sensors.
Capsule Endoscopy just before use. If a patient returns a Battery Pack at the end of an examination and on the following day another examination will take place, immediately recharge the Battery Pack. Recharging a Battery Pack is an overnight process. Note: The rechargeable Battery Pack lasts at least 2 years. After two years of daily use or after 500 rechargings, it is recommended to replace it.
Capsule Endoscopy 4. Use the charged Battery Pack. Given Imaging Ltd.
Troubleshooting Troubleshooting This section describes common problems you may encounter when performing the Capsule Endoscopy, and instructs you on 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 the problem persists, call Given® Imaging Limited technical support Tel: +972-4-909-7706 .
Troubleshooting Data Recorder The following section describes common problems you might encounter while using the Data Recorder during the Capsule Endoscopy. Recorder Initialization PROBLEM During the Check-In process, after clicking Check-In, the message Initializing Recorder stays on and the message Initialization is complete does not appear. SOLUTION • Check the Connection Box connection to the mains and verify that the Connection Box LED is on.
Troubleshooting My computer\properties\Network Identification\Full computer name=RAPID. If not, change to RAPID and restart the computer. Data Recorder Operation To check the Data Recorder operation, always verify that the Data Recorder LED blinks as soon as you connect it to the Battery 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.
Troubleshooting PROBLEM # 2 The Data Recorder LED does not blink while the M2A™ Capsule is held near the Sensor Array. SOLUTION 1. Move the M2A™ Capsule away from the Sensor Array. 2. Disconnect the Battery Pack from the Data Recorder and then reconnect them. 3. Verify that the Data Recorder LED blinks and then turns off. If it blinks and then turns off, bring the M2A™ Capsule close to the Sensor Array. If the Data Recorder LED blinks, you may proceed with the procedure of dispensing the M2A™ Capsule.
Troubleshooting • Call technical support to report the faulty Data recorder PROBLEM #3 Data Recorder LED does not blink when the M2A™ Capsule is in the patient’s mouth. SOLUTION 1. Tell the patient to keep the Data Record belt on, and instruct the patient to take the M2A™ Capsule out of his/her mouth. 2. Hold the M2A™ Capsule next to a sensor attached to the patient’s abdomen. If the LED blinks, ask the patient to ingest the Capsule.
Troubleshooting depletion. (However, the belt must be worn in any event for a minimum of 8 hours.). To check the connection and the Battery Pack, perform the following: • Battery Pack and Data Recorder Connection If there is a problem with the connection, 1. Reconnect the Battery Pack to the Recorder 2. Verify the blinking sequence of the Data Recorder LED: If the LED blinks upon Battery Pack connection and then blinks according to the rate of recording, continue with the examination.
Troubleshooting battery is depleted. Consider completing the examination. If the LED does not blink upon Battery Pack connection according to the blinking sequence, refer to Data Recorder Problem #1. PROBLEM #5 The Data Recorder LED stops blinking during the examination and less than 6 hours have passed since the Capsule ingestion. SOLUTION • Tell the patient to keep the Data Record belt on, and heck the Battery Pack-Data Recorder connection. If there is a problem with the connection: 1. Reconnect. 2.
Troubleshooting If the LED does not blink upon Battery Pack connection, refer to Data Recorder Problem #1. If problem persists, reschedule for another examination at a different date after excretion of the M2A™ Capsule, and contact Given® Imaging Limited technical 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 with the examination and discharge the patient.
Troubleshooting Data Recorder Download PROBLEM The download does not start and the Please Wait message constantly appears. SOLUTION • Check the connection of the Connection Box to the electric socket and verify that the Connection Box LED is on. • Check Data Recorder directory: • Given Imaging Ltd. • Verify that the Data Recorder directory is \rdata. • Verify that the \rdata directory is a shared directory. Use Windows Explorer or My computer.
Troubleshooting Sensor Array Sensor Array Condition PROBLEM The Sensor Array you use is worn or torn. SOLUTION Use another Sensor Array supplied by Given® Imaging Limited. Do not use a torn or a worn Sensor Array. Sensor Location PROBLEM You applied a sensor to the wrong location. SOLUTION 1. 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.
Troubleshooting M2A™ Capsule PROBLEM The M2A™ Capsule does not blink when removed from its blister. SOLUTION Replace the M2A™ Capsule with another M2A™ Capsule, and discard the defective capsule. Given Imaging Ltd.
Troubleshooting Given Imaging Ltd.
Index Index A Add New Patient window, 42 AVI movie, 64 E editing a comment, 66 F C capturing a frame, 59 capturing thumbnail, 53 changing display settings, 31 checking in a patient, 41 comment editing, 66 reading, 65 connecting the Recorder, 48 Control Buttons, 40, 52 creating a movie, 46 D Data Recorder Directory, 46 Defining Data Recorder and Patient RAPID Report, 46 disconnecting the Recorder, 41 downloading, 48 GIven Imaging Ltd.
Troubleshooting moving from repruduction to, 67 pausing, 58 presentation, 52 restart, 56 selecting, 50 speed, 53, 54, 55 time indication, 57 movie file name, 50 movie speed, 52 O Online menu, 39 Options window, 31, 39, 47, 54 P patient registration, 41 Q Quitting the RAPID™ Application, 37 R RAPID™, 29, 31 Main Screen, 31, 35 running, 29 selecting a language, 29 reading a comment, 65 Recorder Download window, 48 removing a thumbnail, 65 S saving a group of thumbnails, 64 saving a thumbnail, 63 Given Imagi
