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PillCam Capsule Endoscopy User Manual, RAPID

1. Given Imagin 3950 Shacklefor Road Duluth GA 30096 USA 0111111111111 11 10 11111XX 111 17 1111 TN LOT XXXX Xx xxxxXXL XX 3 FCC ID O8PGIVENIMAGING Rx Only LBL 1195 02 During recorder initiation the unique capsule ID will be transferred into the PillCam recorder together with the rest of the initiation data It will appear on the PillCam Recorder LCD together with the rest of the patient data As long as no transmission from the checked in capsule is received pairing is not done The Ready for pairing icon 0 0 remains in the top right corner of the screen If there are PillCam capsule transmissions received by the PillCam recorder which are not from the designated capsule the capsule IDs of these other capsules only of the checked in capsule O type are temporarily displayed on the PillCam recorder screen Ready for pairing icon Ds remains in the top right corner of the screen When you open the designated capsule box just before ingestion the capsule starts blinking and transmitting each capsule type in its unique way The PillCam recorder will automatically pair to the designated capsule and start recording when it receives transmissions from it The Pairing success icon P will appear in the top right corner of the screen PillCam Recorder Capsule Pairing DR3 only Performing PillCam Capsule Endoscopy ZG Note Capsule designation during patient check in is the recommended method for
2. 2 Place cursor over area of interest 3 Click and drag without releasing to create a larger circle to include area of interest Mark Arrow Creates an arrow pointing to an area of interest 1 Click ra 2 Place cursor to the side of the area of interest 3 Click and drag without releasing toward area of interest The arrow points to region of interest Undo Mark Clears the last mark created Click repeatedly to successively clear all marks PTh Circumference Scale For ESO procedures only RAPID provides an optional circumference scale for estimating the circumferential involvement of esophageal varices in the Report screen The circumference scale displays 12 equivalent ticks on the image periphery Using RAPID to View a Video 107 PillCam Capsule Endoscopy 108 1 ETH Click 7 in the ribbon of the Report screen Cursor changes shape Rotated scale Point the cursor and click anywhere on the circle to rotate the scale to facilitate estimation of the circumferential involvement of a finding You can rotate the grid as follows a Move the cursor over the periphery of the image The cursor changes into a 4 arrow cursor b Click and drag the scale around to match it to the varices you want to measure Polyp Size Estimation z COLON 2 procedures only Tool for estimating the size of a suspected polyp To use this feature activate it as follows To activate Polyp Size Estimat
3. Additional Settings This section describes advanced configuration features of the RAPID v8 software The section is divided into the following sections e Backup Restore Offline Studies Importing Reports Freeing Space on Your Computer Backup System Logs Advanced CD DVD Burning Backup Restore Offline Studies The RAPID Study Manager displays information about studies stored on removable storage media such as CDs DVDs and some USB storage devices that have been connected to the computer during use of RAPID and are currently disconnected from the computer After clicking the Offline Studies button in the Study Manager a list of recently viewed studies which are 156 Additional Settings Configuring RAPID Software currently not connected to the computer is displayed The offline study list is updated whenever the removable storage media is disconnected or reconnected To back up the list of the Offline Studies to a database file use the RAPID Backup amp Restore Offline Studies utility To backup Offline Studies 1 You can backup the Study Manager Offline Studies by clicking the Windows Start button and then selecting Given Imaging gt Backup Restore Offline Studies The following screen appears ta Backup and Restore Offline Studies E GI yEN Expand IMAGING ng the scope of Gi Select action Export directory Import directory Back Next Cancel 2 Select Export Di
4. Caution e Keep the PillCam capsules in their box until use eo e Store the PillCam capsules only in packaging supplied with the product e Do not use a PillCam capsule if packaging is damaged e Keep the capsule package away from strong magnetic fields such as MRI devices e Stack PillCam capsule boxes with the clear lid facing up only never stack capsule boxes lid to lid e Keep metal objects away from the lid of the capsule box e For COLON 2 procedures After ingesting the PillCam colon capsule instruct the patient not to sit on bare metal surfaces such as chairs with metal sitting area during the procedure PillCam Recorders The PillCam recorder is a compact battery operated unit worn by the patient during the procedure It receives and stores the image data transmitted by the PillCam capsule There are two models currently available PillCam recorder DR3 and PillCam recorder DR2 The PillCam recorder 1s supplied with a pouch to wear over the shoulder and with an adjustable strap to secure to the waist A DR2 DR3 PillCam Sensors The PillCam sensors are physical receptors that receive transmission data from the PillCam capsule and transfer it to the PillCam recorder These sensors are placed on the patient as a sensor belt or a sensor array PillCam sensor belt The sensor belt is worn around the patient s waist over a thin shirt PillCam Capsule Endoscopy System Components 15 PillCam Cap
5. Unselect All Thumbnails Ey Save Joined Segment e De Identify 9 5 Preview Print Save Save Sendas Export Save Clip Attachment Images are Th ai Q Delet Configure Ca Report Image Data a Markings Lewis Score xX Calculated Score Lewis Score 0 1st SB Tertile 0 2nd SB Tertile 0 3rd SB Tertile 0 Stenosis 0 Descriptor Input Current tertile rase Ten Villi Ulcers enosis Appearance _ Normal Number None None _ Edematous _ Single Single Short segment Few ES Multiple Longitudinal extent 1 Multiph ultiple Long segment _ Whole tertile Longitudinal extent Short segment Long segment Distribution _ Single 3 _ Whole tertile Patchy Diffuse Circumferential extent Less than 1 4 7 1 4 1 2 F Greater than 1 2 COI x ii z 01 14 55 E Current tertile The tool is used for calculating the Lewis Score and is enabled only when all of the following conditions are met e itisa PillCam SB video e thumbnail images of the small bowel have been created e the first duodenal and first cecal images are marked as landmarks To use the Lewis score 1 Click in the ribbon of the Report screen The Lewis Score screen appears e The current thumbnail is visible at the right side of the screen e The Lewis score is at the top of the screen and the right panel next to the thumbnail entitled Stenosis relate to the entire sma
6. fo Conttraindications Indications Contraindications Warnings Cautions Adverse Events Potential adverse events associated with the use of this device include delayed or no excretion of the capsule and aspiration In some instances intervention is required to remove the capsule Potential adverse events associated with the use of this device may include obstruction perforation and mucosal injury or bleeding Summaries in published literature identify the risk of retention for obscure bleeding to be 1 5 for suspected Crohn s disease to be 1 4 for Known Crohn s the risk is higher at 5 and for neoplastic lesions the rate of retention is 2 1 as compared to healthy volunteers 1 2 References 1 Cave et al Endoscopy 2005 37 1065 1067 2 Zhuan et al GI Endoscopy 2010 71 280 286 Warnings A Warning indicates a condition that may endanger the patient or the user e The capsule should not be swallowed by children under the age of 8 years or by patients where a concern for aspiration of the capsule exists e g due to cognitive or neurological deficits or a history of aspiration In these patients it is recommended a capsule endoscopic delivery system is used to place the capsule directly in the duodenum Placement of the capsule in the duodenum will decrease the risk of aspiration of the device by vomiting and gastric retention e A negative or normal result obtained by the PillCam video capsule does not exclude the
7. Cases Diagnosed Cases correctly Agreement Diagnosed by CE by EGD Hiatal Hernia 37 Stricture 5 Polyps Nodules 3 Varices 1 6 1 0 1 16 20 0 100 BO Note The PillCam ESO capsule was not able to reliably identify e Precise location of lesion s e Length or extent of lesion s e Severity or grade of lesion s 10 Accuracy of the Device ESO Indications Contraindications Warnings Cautions Accuracy of the Device COLON A combined analysis of three studies performed on patients with suspected colonic polyps was performed It includes 202 patients who underwent both PillCam COLON 2 capsule endoscopy PCE and conventional colonoscopy The studies were designed to assess the detection of colonic polyps The accuracy parameters for PCE in detecting patients with polyps gt 6mm and polyps gt 10mm were evaluated against colonoscopy which was considered as the gold standard Results are presented in the table hereafter Sensitivity Specificity Polyp size 95 Cl 95 Cl 84 77 90 79 74 82 82 72 88 94 91 96 Capsule endoscopy of the PillCam COLON 2 system appears to show good sensitivity and specificity for detecting patients with polyps gt 6 mm and gt 10 mm Accuracy of the Device COLON 11 PillCam Capsule Endoscopy 12 Accuracy of the Device COLON Chapter 3 Welcome to PillCam Capsule Endoscopy What is PillCam Capsule Endoscopy The PillCam capsule endoscopy procedure 1s a
8. To cancel video creation 1 Click End Video Creation 2 Click Yes to end the compilation or click No to continue compilation Managing RAPID Video Data You can copy the video data from the PillCam recorder to the computer a USB storage device or a DVD without compilation into a video Video data management is disabled per default To enable video data management 1 From the Home screen select Tools gt Settings RAPID siant Patient Check in p t Recorder Download p E View Study y ettin Atlas User Dictionary System Wide Settings gt GIyEN Y IMAGING 2 Select the Video tab 3 Under Video Data Management Disable video data management is selected per default Select either Copy raw data or Compile raw data 70 Managing RAPID Video Data Creating RAPID Videos You can copy the video data from the USB storage device or a DVD onto a workstation for video creation see From Raw Data Files USB Storage Devices on page 70 Copy Data from a PillCam Recorder To copy video data from a PillCam recorder 1 Place the PillCam recorder in the cradle Make sure that the cradle is connected to the personal Computer PC 2 From the Home screen click Recorder Download The Procedures screen appears with the Recorders tab on top 3 Click the Recorder bar that corresponds to the PillCam recorder with the desired data e When the correct Recorder bar is activated and you
9. 1 Find the study in the Offline studies list 2 Locate the volume listed 3 Connect it to the computer To save the Offline Studies list us the Backup Restore feature for Offline Studies see Backup Restore Offline Studies on page 156 ALG Note DO NOT remove the USB storage device until after any actions performed with it are completed 88 Using the Study Manager Reviewing and Interpreting RAPID Videos Overview of the RAPID Interface In the RAPID v8 software a wide band spans the top of the main program window This ribbon is comprised of three tabs Each tab on the ribbon has different buttons and commands that are organized into ribbon groups This ribbon replaces the menus and toolbars in previous RAPID versions When opening a RAPID video the RAPID user interface displays the View tab This tab contains many of the most frequently used commands for viewing a RAPID procedure video The ribbon interface is designed to help you quickly find the commands that you need to complete a task Commands are organized in logical groups which are collected together under the View and Report tabs When working with study videos the controls you need for viewing annotating and creating reports are arranged in ribbons which group similar functions together There are three basic components to the ribbon e Ribbon Tabs There are three ribbon tabs File View and Report that span across the top Each one represents an activi
10. 3 2 MHz MSK 33 19 fps 30 minutes Resistant to dissolution in pH 2 to pH 8 Silver Oxide batteries 20 40 C 0 50 C System Specifications PillCam ESO 3 Capsule Properties Physical Dimensions Weight Material Optical Illumination of optical heads Field of view Effective visibility Min detectable object Frequency Band width Modulation ERP nW Operational Frame rate Operating time Chemical safety Battery type Operating temperature Storage temperature System Specifications Technical Description Length 31 5 mm Diameter 11 6 mm 2 9 gr Biocompatible plastic 4 white light emitting diodes for each head 2 172 SO 8600 3 for each head Distance 3 cm At least 0 1 mm 434 1 MHz 9 7 MHz MSK 8 35 fps 30 minutes Resistant to dissolution in pH 2 to pH 8 Silver Oxide batteries 20 40 C 0 40 C 183 PillCam Capsule Endoscopy 184 PillCam COLON Capsule Properties Physical Optical Operational Dimensions Weight Material of optical heads Illumination Field of view Effective visibility Min detectable object Frequency Band width Modulation ERP nW Frame rate Operating time Chemical safety Battery type Operating temperature Storage temperature Length 31 0 mm Diameter 11 4 mm 2 9 gr Biocompatible plastic 2 4 white light emitting diodes on each side 156 ISO 8600 3 Distance 3 cm At least 0 1 mm
11. Caution Voltage mismatch will damage the RAPID workstation eo _ JRS Note For workstations use the monitor s native screen resolution according to the monitor user manual Connecting the PillCam Recorder Cradle You can connect the cradle only to the USB2 ports that are side by side in a separate slot on the back panel of the Workstation If you are not using a Given Workstation use a USB hub for connecting more than one cradle to your computer JK Note If you use more than one cradle make sure each one is connected to a different power outlet 132 Main Endoscopy System Components Starting RAPID for the First Time Installing RAPID Software Before using the RAPID software you must configure and personalize it 1 administrator For the RAPID workstation log in as follows single user mode log in with the username rapid and leave the password blank multi user configuration log in with your username and password created for you by the AS Note RAPID installed not on a Workstation and RAPID Reader do not require login 2 Click on the desktop J RAPID End User License Agreement GIVEN IMAGING LTD RAPIDTM SOFTWARE LICENSE AGREEMENT PLEASE READ THE TERMS AND CONDITIONS OF THIS LICENSE AGREEMENT CAREFULLY BEFORE PROCEEDING WITH INSTALLATION OF THE RAPIDTM SOFTWARE WHICH IS LICENSED TO YOU HEREUNDER EITHER RAPID RAPID ACCESS RAPID READER RAPID PH OR RAPID REAL TIME HEREINAFTER THE
12. PROGRAM AND THE THIRD PARTIES SOFTWARE DELIVERED AND INSTALLED TOGETHER WITH THE PROGRAM BY CLICKING THE YES BUTTON YOU ARE ACCEPTING AND AGREEING TO ALL THE TERMS AND CONDITIONS OF THIS LICENSE AGREEMENT AND THE THIRD PARTIES EULAS AS DEFINED BELOW THE PROGRAM INSTALLATION INCLUDES THIRD PARTIES SOFTWARE AND OR LIBRARIES THIRD PARTIES SOFTWARE AND MAY INCLUDE ASSOCIATED PRINTED MATERIALS AND ONLINE OR ELECTRONIC DOCUMENTATION NOTE HOWEVER THAT ANY SUCH THIRD PARTIES SOFTWARE LIBRARY DOCUMENTATION OR SERVICES THAT ARE ACCOMPANIED BY THEIR OWN LICENSE AGREEMENTS OR TERMS OF USE THIRD PARTIES EULAS ARE GOVERNED BY SUCH AGREEMENTS RATHER THAN THIS LICENSE AGREEMENT AND BY ACCEPTING THIS AGREEMENT YOU ACCEPT THE THIRD PARTIES EULAS AS WELL THEREFORE IF YOU ARE NOT WILLING TO BE BOUND BY ALL OR ANY Language f nglish k Yes No r RAPID Registration Version Information Version 80 31 System ID 6f2qtm1 System Key af27 7f5c Enter registration key contact customer support Later 7 uses remaining Starting RAPID for the First Time When you run the software for the first time a license agreement in English US appears on your screen which is the legally binding version A translation in other languages is provided Read license agreement and click Yes to accept it You may select another language to read it but you must reselect English to accept the license
13. System Specifications PillCam SB 3 Capsule Properties Physical Dimensions Weight Material Optical Illumination of imaging heads Field of view Effective visibility Min detectable object Frequency Band width Modulation ERP nW Operational Frame rate Operating time Chemical safety Battery type Operating temperature Storage temperature Downlink communication Operating frequency Receiver Bandwidth System Specifications Technical Description Length 26 2 mm Diameter 11 4 mm 3 0 gr Biocompatible plastic 4 white light emitting diodes 1 156 ISO 8600 3 Distance 3 cm At least 0 07 mm 434 1 MHz 3 2 MHz 2 7 Mbps 6 5 MHz 5 4 Mbps MSK 20 2 fps or 2 6 fps gt 8 hours Resistant to dissolution in pH 2 to pH 8 Silver Oxide batteries Mercury Free 20 40 C 0 25 C 13 6 MHz 150 KHz 181 PillCam Capsule Endoscopy 182 PillCam ESO 2 Capsule Properties Physical Optical Operational Dimensions Weight Material Illumination of imaging heads Field of view Effective visibility Min detectable object Frequency Band width Modulation ERP nW Frame rate Operating time Chemical safety Battery type Operating temperature Storage temperature Length 26 4 mm Diameter 11 4 mm 2 9 gr Biocompatible plastic 4 white light emitting diodes for each head 2 169 ISO 8600 3 for each head Distance 3 cm At least 0 1 mm 434 1 MHz
14. gt eRe ne ee ee ee ee ene ene eee eee 83 e A tae ere ere ne ae ee eee ee a 87 OMAE Std CS ora eii 88 Overview OF th RAPID IMICM aCe iniciado 89 Dialog BOX aun Ss da 89 Quick Access Tocata coo ae bend estou cacon 90 El VIO Wes suscitan tt ita 91 VIEW SCICON ooa e e le eo 92 VISW RIO o a e a O alow 93 Using RAPID to VIEW a Video iis esesiciscde coewenitacenctiiatedensonasiedesdivinnl 99 Reading a Capsule Endoscopy Video cooccoccoconoconoconoconoconononocanonanonanonanonanonanonanenanenos 99 MIG WING a VIA SO resta cin ld e aid 101 Wal IGA MS Wise 101 SBI VICON ena dnd a les da 102 Time Bat COB e o od 102 Creating and Annotating ThumbnallS ooccocccccccccnoconnnoninonnnnnnnncnnncnnnnnnnnnnnnnnononanoss 103 Using Localization and LandmarkS oococccccnccccocncocicconononnnnnnonononcnnanonnonanonnnnnnnonnnanenennos 109 Comparing TAUMDNANS susccricinn tdt 112 RAPID Video PINGS aia iii 114 VWVOFKING WIN FINQINOS iii 115 savna YOUN FNAN sanen a e eo 115 ODENING a RINdINds Fl lr iO don Det E ed 115 Creating a PillCam Capsule Endoscopy Report cccccceeseeeeeceeeeeeeeeeeeeseneceesanseneseaes 116 A AE an cataecandentuan aval caeceaceuantateckasagnes Meccan soe 116 REDOM RIDDO siaina a teeta aera cence adeeb ea Neca e a a a a 117 Given Imaging jii PillCam Capsule Endoscopy RAPID AMS can ias 121 Comparing Video Images to Atlas IMages ooccoccconcocnconconnconccnnoncccnncononnncnnnonnnonon
15. oocccccoocccnnnnononnncnononoss 171 a A 28 CAMS rial icatatsds 59 Capsule Ingestion ata 60 cardiac PACEMMIAKETS nn 4 Cde 83 CD DVD burning Study Manager 83 charging PillCam recorder DR2 54 A tence citar Reais teal tia 6 circumference Scale cooonncnnnnnoccnnncnononnnnnos 107 Clear Diguid Dita 22 Clps MAGES arta 128 COLON 2 Sensor Locations oocccccnooccnnnnooo 37 Colon Location Diagram 666 110 112 commands Configure SOUP indian 117 Image Adjustment group cseecceees 96 Image Data group ccccccoccnnncnononnncnanonoss 127 Markings group sscccccesseeceeeeeeeeeees 120 Preview CLOUD ia 93 Report grOUP saersi eroaisi 119 REVIEW OTOU aaa 95 Show group scsieovssetindviswenenvssetneadsensseovean 98 Viewing Layout group o ccccccooccnncnoncnnnnnos 95 Zoom group ii 98 Comments Edita 105 Given Imaging Index compare thumbnails ooccccncnocnnncnococnnnno 112 Components PillCam Capsule Endoscopy System 13 Contramdicaton Sii 4 CQV Complementary QuickView 100 cradle troubleshooting occccccnoccnnnnoconnnnnononoss 171 CHAR IM A TETEE 46 ercate a thumbnail aid 103 CLEAUINO a VIGEO serrie n ER E 67 Crohns disease os 8 Customer Support ooocccnnnnocccnnnnoconnnnnoconnnnnonos 18 D defibrillators ratito ds 6 Delay First Instruction c ceeeceee 28 52 delete asid ias 87 delete multiple studies
16. 12 43 O AS Note Using Real time Viewing on the PillCam recorder with an external real time viewer laptop is not supported In procedures with AFR mode capsules PillCam SB3 and PillCam COLON 2 the AFR icon appears above the right navigation button while the capsule is not in AFR mode to allow the user to manually activate the AFR mode of the capsule even before automatic activation After activation of the AFR mode in the capsule either manually or automatically the recorder status icon in the top status line changes from paired 4 to AFR 8 The icon displayed above the right navigation button is the mark icon P that allows the marking of the displayed image for automatic creation of a thumbnail and to facilitate further scrutiny of the image off line in the created video In procedures with non AFR capsules PillCam SB2 PillCam ESO the icon that appears above the right navigation button in real time viewing is the mark icon P l For COLON procedures instruction 1 on the PillCam recorder screen appears after the capsule enters the small bowel usually within two hours of ingestion The AFR icon AFR simultaneously Real Time Viewing with PillCam Recorder DR3 Only Internal Mode 63 PillCam Capsule Endoscopy appears in the status line at the top of the PillCam recorder screen designating the fact that the PillCam COLON 2 capsule passed into the AFR mode operation If the system does not show instruction 1 or the
17. Overview of the RAPID Interface 93 PillCam Capsule Endoscopy Preview Group buttons Button gt D 94 Function Collage view for COLON 2 procedures only In the Collage view relevant parts from selected images of interest are cropped and arranged in a matrix to provide an overview of the most interesting image elements from the study video This layout contains 8 rows and the maximum number of the columns that can fit on the display dependent on resolution Use the navigation buttons or the scroll wheel on the mouse to view the next matrix When hovering on an image in the collage the complete image with both the previous and next images will be displayed on the left side of the screen The Collage View must be enabled in the Settings see Research Tools Section on page 140 Collage view is not intended for diagnostic review and should not be used as a substitute for reviewing the video in one of the other viewing layouts SBI mode Sets the Suspected Blood Indicator SBI previewing mode to show marked images suspected of containing blood for fast review in sequence SBI image locations are marked on the color bar see SBI View on page 102 QuickView mode Sets the QuickView previewing mode to show only significant images that may be of interest in the video stream to provide fast previewing and landmarking of a video The number of images to be considered images of interest can be set as percentage of the video by th
18. The Settings screen appears showing the General tab After making the changes to the settings click Apply to accept the new settings or click Cancel to close the Settings screen without accepting any changes Clicking OK will accept the new settings and close the Settings screen e R Settings General User Information Physician name Dr Schnaider v Clear physician name when new video opens Facility details Change Logo f Clear Logo Regional Settings Language English F V Enable spell check Y Enable GI Dictionary Measurement units Metric cm Kg v Full name format First Middle Last v Permissions RAPID users must belong to this network group P system Wide Cancel User Information Section The physician name facility name and address where the procedure was performed and the facility logo entered during configuration show on the endoscopy report To define user information 1 From the Home screen select Tools gt Settings The Settings screen appears 2 Inthe User Information section type in the Physician Name User Information Physician name Dr Schnaider _ Clear physician name when new video opens Facility details y Change Logo Clear Logo If you do not enter the physician name here no physician name appears on the CE report RAPID Settings 137 PillCam Capsule Endoscopy 3 Ifmore than
19. The default directory is designated in Settings Close Closes the Regimen Manager Pre Ingestion Patient Instructions A completely clean colon is essential for a successful examination Therefore the patient must carefully adhere to the preparation procedure for cleaning the GI tract The Regimen Manager can be used to create instructions for the patient to follow before the planned COLON capsule endoscopy procedure The instructions identify the type of medications and liquid intake that must be taken in order to prepare the colon prior to the procedure These preparation instructions can be edited and printed out for the patient beforehand There could be different instructions appropriate to different circumstances or available medications Pre capsule ingestion patient instruction sets can be created and edited to maintain a library of valid usable regimen instruction sets To edit and save pre capsule ingestion regimen instructions 1 From the Home screen select Tools gt Regimen Manager RAPID sica Patient Check in Ey Recorder Download y gt 7 Tools zA Regimen Manager Aao 5 tiro Atlas a User Dictionary System Wide Settings gt Ci The Regimen Manager screen appears 2 Select the Pre capsule Ingestion tab The Regimen screen appears displaying all available pre ingestion regimens 3 Open a regimen by double clicking it or selecting it and clicking Open Regimen Ma
20. designating a capsule to be used in the procedure Capsule Designation Before Capsule Ingestion There are two situations when you need to perform capsule designation manually immediately prior to ingestion e if designation was not performed during check in or e designation was performed but the designated capsule is not available for the procedure As long as there are PillCam capsule transmissions received by the PillCam recorder but are not from a designated capsule the capsule IDs of these other capsules only of the checked in capsule type are temporarily displayed on the PillCam recorder screen The Ready for pairing icon remains in the top right corner of the screen To designate and pair a capsule to be used in the procedure before capsule ingestion 1 Open the capsule box lid the capsule starts blinking each capsule in its unique blinking pattern see System Specifications on page 179 Right after opening the lid the blinking rate for PillCam SB3 and PillCam COLON 2 capsules should still be 2 fps per head the same as for PillCam SB2 For PillCam SB2 fixed 4 fps variant the blinking rate should be 4 fps For PillCam ESO2 the blinking rate is 9 fps per head and PillCam ESO3 the blinking rate is 18 fps per head Hold the capsule close to the sensors worn by the patient during this pairing process 2 When the Ready for pairing icon 0 0 is displayed in the top right corner of the screen and when the PillCam recorder detect
21. e To minimize the potential for radio frequency interference from the capsule after it is removed from the box verify that the capsule LEDs are blinking and have the patient ingest it immediately e Once the RAPID video is created check to be sure the video is complete Capsule Ingestion Performing PillCam Capsule Endoscopy PillCam Recorder DR3 1 Remove blinking capsule from its box and give to patient Do not touch the optical domes 2 Make sure that the capsule and the capsule LED on the PillCam recorder are blinking in time with each other 3 Check the color of the capsule LED on the PillCam recorder e If O blue go to step 4 e If white pair the capsule with the PillCam recorder and verify the pairing success icon y appears in the top right corner of the PillCam recorder screen and the capsule LED blinks blue O NS Note During capsule endoscopy the capsule LED blinks blue at the recording rate If the capsule LED blinks orange once every 5 seconds the PillCam recorder is not receiving capsule signals see PillCam Recorder DR3 on page 171 for troubleshooting details 4 Have the patient swallow the capsule with a sip of water The ingestion procedure may take several minutes PillCam Recorder DR2 PillCam ESO Capsule Endoscopy The PillCam recorder starts blinking when the capsule has been activated 1 Position the patient on the bed with a pillow 6 cm or 2 5 inch high under the head to facilitat
22. information JER Note To export video clips and images without patient information click the De Identify checkbox in the ribbon Generating a Report 129 PillCam Capsule Endoscopy 130 Generating a Report Appendix A Installing RAPID Software Setup Requirements Set up your office to accommodate the new PillCam Capsule Endoscopy System Review the following workstation specifications Four electrical outlets are required to connect the following components workstation computer monitor printer and one cradle Each additional cradle requires an additional outlet NE AAN eo _ Note e You may use a Given approved power strip e You may connect your monitor directly to the workstation using a DVI cable the DVI VGA adaptor is not required Caution Do not connect any component of the PillCam Capsule Endoscopy System to the same outlet together with any appliance or device that has a high power requirement refrigerators generators devices with motors etc When setting up the system make sure that the total power requirements for all of the devices connected to a single outlet or circuit do not exceed the rated limit for that circuit If you are not sure of the rated limit please consult your maintenance department or an electrician Do not use a KVM Keyboard Video Mouse Switch with the PillCam Capsule Endoscopy System Note Extra space is needed for air circulation and cable connectors behind
23. patency of the GI tract in patients with known or suspected strictures Risks PillCam capsule endoscopy is not for everyone PillCam video capsules are contraindicated in patients with known or suspected gastrointestinal obstruction strictures or fistulas in patients with cardiac pacemakers or other implantable electromedical devices and in patients with swallowing disorders PillCam patency capsules are contraindicated in patients with swallowing disorders The PillCam patency scanner is contraindicated in patients with cardiac pacemakers or other implanted electromedical devices Capsule retention has been reported in less than two percent of all capsule endoscopy and patency procedures Capsule retention is defined as having a capsule remain in the digestive tract for more than two weeks Causes of retention cited in the literature include NSAID strictures Crohn s disease small bowel tumors intestinal adhesions ulcerations and radiation enteritis Summaries in published literature identify the risk of retention for obscure bleeding to be 1 5 for suspected Crohn s disease to be 1 4 for known Crohn s the risk 1s higher at 5 and for neoplastic lesions the rate of retention is 2 1 as compared to healthy volunteers 1 2 To verify passage of the capsule from the GI tract an abdominal X ray may be obtained at the discretion of the physician The capsule can be removed using medical endoscopic or surgical intervention There 1s
24. patient to immediately contact the physician e When swallowing the capsule there is a possibility of choking on the capsule If the patient exhibits any symptoms and or clinical signs of choking labored breathing wheezing involuntary coughing etc the recommended protocols should be followed e Ifa child has accidentally swallowed any unused or spent PillCam video capsule seek medical attention e A PillCam video capsule should be ingested only in the presence of authorized medical personnel The patient should be instructed not to let relatives neighbors or acquaintances use any PillCam video capsule without medical attention e If excretion of the PillCam video capsule from the patient has not been positively verified and the patient develops unexplained postprocedure abdominal pain vomiting or other symptoms of obstruction he she should contact the physician for evaluation and possible abdominal X ray examination e Undergoing an MRI while the PillCam video capsule is inside the patient s body may result in serious damage to his her intestinal tract or abdominal cavity If the patient did not positively verify the excretion of any PillCam video capsule from his her body he she should contact the physician for evaluation and possible abdominal X ray before undergoing an MRI examination e The safety of this device in pregnant women has not been established e The safety of this device in patients with significant gastrointes
25. placed it into the cradle the PillCam recorder automatically starts charging Disclaimer The PillCam recorder cradle is a non medical device used for charging the PillCam recorder from Given Imaging Ltd For full specifications see System Specifications on page 179 Important Safety Instructions e A A Given Imaging Note Before using the PillCam recorder cradle read all instructions on cautionary markings on the cradle on the battery and on the PillCam recorder Warning Changes or modifications to this equipment not expressly approved by the party responsible for compliance Given Imaging Ltd could void the user s authority to operate the equipment Warning e The cradle is for indoor use only e Never charge non rechargeable batteries e All cells containing mercury cadmium or lead as electrochemical substances are subject to special waste disposal requirements e This charger is a class A product In a domestic environment this charger may cause radio interference 163 PillCam Capsule Endoscopy Note This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmf
26. 1 2 Given Imaging Verify that no contraindications apply to the patient see Contraindications on page 4 Inform the patient a b Inform the patient of the small possibility of bowel obstruction Inform the patient of the importance of a clean bowel for the success of his or her PillCam examination C Instruct the patient what to expect before during and after the procedure Instruct the patient on the proper use of the PillCam recorder e The patient must treat the PillCam recorder with care Avoid any sudden movements Avoid bumping it e The patient should not remove or disconnect the PillCam recorder at any time during the procedure e The patient should contact the medical staff if the PillCam recorder is blinking red or white e The patient must follow the dietary instructions from the medical staff or when alerted by the PillCam recorder If the patient experiences any abdominal pain nausea or vomiting after ingesting the PillCam capsule the patient should immediately inform the medical staff After ingesting the PillCam capsule and until it is excreted the patient should not go near any source of a powerful electromagnetic field such as one created near an MRI device and should avoid direct exposure to bright sunlight If the patient experiences any post procedure abdominal pain vomiting or other unexplained symptoms and PillCam capsule excretion cannot be verified the patient should conta
27. AT he ia Users Desktop v y Search De p Ongance Hew folder 7 id ds r Favorites sages di TODO pa i To pont a Libranes d mis t CMDE_20120327 accdb Documents a pr Documents Shortcut Mus k Pictures H Vode E Computer a Local Dizk tC de datatranster de dell de drettrnp de Intel L Ma Hie name CMDB 20120327 sccdb Microso Access acodb Lancel Importing Reports Reports generated by RAPID versions before RAPID 5 are not automatically displayed in the Study Manager If you wish to be able to see them in the Study Manager you must import them by doing the following To import reports 1 Open the video of the relevant study 2 Select File gt Tools gt Import RAPID 4 Reports The following message appears Ensure that the selected reports belong to this study 3 Click OK 158 Additional Settings Configuring RAPID Software A Windows browser screen opens at the location of the currently open video showing the reports that are in this folder 4 Select the report s you wish to import If the report is not in this folder browse to the correct location and select the report 5 Click Open The message The reports were imported successfully appears 6 Click OK and repeat this procedure for all the studies performed before RAPID 5 Freeing Space on Your Computer Deleting Videos If you start to create a video while there is not enough space on your computer you will be promp
28. Last First and Middle names into the appropriate fields Use alphanumeric underscore hyphen and space characters Use the TAB key to move to the next field Enter the patient ID number in ID c Select the Gender In Birth Date use the arrows to set the date In Procedure Date enter the date on which the procedure is to be performed By default it is set for current date In Capsule ID if filling this field during check in enter the capsule ID code that is printed on the bottom of the capsule box by typing it in or by using a barcode The capsule type field is automatically populated according to the capsule type encoded in the capsule ID entered Capsule ID XXXXXXL DA Lli LE AO Given Imaging 3950 Shackleford Road Duluth GA 30096 USA 123 ABC 1 01M1111111111111 1 11111111 17 111111 10 11111XX ai LOT XXXX XX XXXXXXL XX pes FCC ID O8PGIVENIMAGING Rx Only LBL 1195 02 In Capsule Type if you have not filled in Capsule ID in the previous field select the correct type of procedure SB2 SB3 ESO2 ESO3 COLON or COLON2 If you have filled in the Capsule ID field this field will auto populate with the corresponding capsule type For DR2 recorders in the Sensor Type drop down list select the sensor type Only those sensor types appropriate for the selected capsule type field value will appear in the selection menu To ensure accurate localizatio
29. PillCam Capsule Endoscopy Report on page 116 QuickView Use the QuickView feature to perform a fast preview of the video Quick View makes RAPID video review more efficient by displaying only images that may be of interest in the video stream to provide fast previewing and land marking of a small bowel video The number of images to be considered images of interest can be set as percentage of the video by the user The RAPID scans all images and scores them according to the possible level of significance Then according to the percentage level set by the user it displays a short video to provide an overview of the case prior to full review The recommended viewing speed is 7 10 frames per second using Single View layout Using RAPID to View a Video 99 PillCam Capsule Endoscopy 100 Scan the entire video in Quick View mode to e Establish approximate landmarks for the first gastric first duodenal and first cecal images e Capture thumbnails of images of interest e QuickView may be used to review gastric and colon images ALG Note The QuickView feature is not intended to detect pathology in lieu of a physician and should not be used as a substitute for reviewing the entire video e The absence of a particular frame from the QuickView display should not be interpreted to mean that no abnormal finding is present in that frame e SBI images are also included in the QuickView e The QuickView by no means replaces a thorough viewing of the
30. RAPID Settings on page 136 e Atlas opens an atlas of typical disease images searchable by key descriptors and used as a viewing aid for comparing study images with reference images see RAPID Atlas on page 121 e Delete Videos Delete a RAPID video folder and its contents see Freeing Space on Your Computer on page 159 e User Dictionary Import or export term dictionary used in writing comments and study summary o0 Regimen Manager settings Atlas Delete Videos User Dictionary PillCam Capsule Endoscopy System Components 17 PillCam Capsule Endoscopy 5 Help clicking this button opens a menu that provides access to d nee Online Help Customer Support gt Help Center About Help Selecting Online Help in the submenu opens a searchable PDF version of this user manual Selecting Help Center will direct you to the RAPID Help Center The Help Center provides quick references for How to questions and additional tools including video clips and step by step demonstrations to facilitate learning of Capsule Endoscopy procedures and the RAPID software Customer Support The menu provides a link to Given Imaging contact information for customer support see Customer Support Section on page 146 an option to collect analysis files and to show the RAPID log 6 Exit closes the RAPID software RAPID software is supplied as e Software only installs on your PC e RAPID workstation dedicated PC with RAPID pre ins
31. Using a tactile and sound alert the PillCam recorder will notify the patient of a scheduled event by displaying the event number on the LCD screen The patient needs to refer to this number on the Post Ingestion Patient Instructions printout given by the medical staff The following section explains how to edit the Post Ingestion Patient Instruction Approved regimens can be selected during the patient check in stage and can be printed see Performing Patient Check in on page 24 To edit and save a post ingestion regimen 1 From the Home screen select Tools gt Regimen Manager RAPID sica E Patient Check in y E Recorder Download View Study y 4 Tools gt a Manager mci MI User Dictionary gt GIyEN Y IMAGING 2 Select the Post capsule Ingestion tab The Post capsule Ingestion Regimen screen appears displaying all the post ingestion regimens available 3 Open a regimen by double clicking it or select it and click Open The Notes field on the top right allows the typing of information for the specific regimen It will not appear on the printout Regimen Manager 151 PillCam Capsule Endoscopy 4 To add an instruction to the regimen click Add instruction and select from the list the appropriate timing for the instruction When typing the instructions in the Instructions for Patient a pop up screen appears if the text is too long 5 Type any other information in the Additional Instr
32. a study as Zip file Saving a Study to a CD DVD The Study Manager allows you to burn a study or specific files of a study to a disc with the following restrictions e No multi session disc burning once a disc is burned you can not add any other data to it e You can burn either the whole study all the files in the folder or one single file For advanced options see CD DVD Burning on page 160 Using the Study Manager 83 PillCam Capsule Endoscopy To save a study to a disc 1 Insert a blank CD DVD in the drive 2 Open the Study Manager by clicking Eze at the top of the screen or select View Study gt Study Manager from the Home screen 3 Select a study from the list on the Study Manager to export to CD DVD 4 Click Export The following screen appears M Epor Study z JIS Note Exporting does not move the study files but creates a copy of them to the desired location 5 Select either Entire study or Specific files If you select Specific files a window opens inside the screen showing the files for selection If you wish to remove all personal patient information select the check box De identify at the bottom of the screen The size of the file is displayed below the check box 6 Click Next 7 Select Specific Location under Select destination and click Next 84 Using the Study Manager Reviewing and Interpreting RAPID Videos The following screen appears r Save Directory
33. agreement Unrestricted use of RAPID requires registration via the Given Imaging registration center You must supply requested information to obtain the Registration Key The registration screen appears at the end of the installation process 133 PillCam Capsule Endoscopy 134 LN Note Keep the registration wndow open until you finish the registration Each time you open the registration window a new System Key appears and any Registration Key based on a previous System Key will not be accepted If you click Exit you can open and use the RAPID software but after seven uses without registering you must first perform registration in order to use RAPID Obtain a Registration Key via the Given Imaging registration center online or by phone e Online https portal givenimaging com RapidRegistration e By phone call your local Given Imaging customer support center Be ready to provide the Given Imaging registration center with the following information e System ID from the registration screen e System Key from the registration screen e RAPID DVD serial number supplied with the DVD e Your customer ID Enter the Registration Key received from the Given Imaging registration center using ONLY lower case letters and numbers Click OK E Note If you do not register during installation the next six times you open RAPID you will be asked to register After seven uses without registering you cannot use RAPID without first
34. an extremely rare risk of capsule aspiration while patients are attempting to swallow a PillCam video capsule or PillCam patency capsule There is also a low risk of skin irritation from the sensor array sleeve adhesive or silicone exposure The PillCam SB video capsule and or the PillCam patency capsule may be administered by using transendoscopic delivery in patients who are either unable to ingest the capsule or are known to have slow gastric emptying time If using transendoscopic delivery potential complications include but are not limited to perforation hemorrhage aspiration fever infection hypertension respiratory arrest cardiac arrhythmia or arrest All medical procedures carry some risks Information in this manual should not be used as a substitute for talking with your doctor about diagnosis and treatment Benefits and Risks PillCam Capsule Endoscopy Indications Contraindications Warnings Cautions References 1 Cave et al Endoscopy 2005 37 1065 1067 2 Zhuan et al GI Endoscopy 2010 71 280 286 Accuracy of the Device SB The PillCam Capsule Endoscopy System with the PillCam SB capsule was studied in a series of 20 subjects with hemoccult positive stool iron deficiency anemia and or subacute hematochezia or melena All patients had undergone unrevealing colonoscopy gastroscopy enteroscopy and small bowel x rays prior to enrolling in the study When compared to repeated push enteroscopy the PillCam video
35. and O leacsscta cosacos 44 REJIMEN Reminder escenas ganaras ne e eto cod E el ceca ca ae 45 A o a nee ee ee eee ee ee ee 46 CONTO enact eu coutey E E wel acunatoeusenauedcduade cen ances eenaunceb coat 46 PiINC aM Recorder DRZ siria 93 A A A 93 tuning On A E nag P tiene idhebulaetedonse cea 53 A Pe EEE E N Ore ae re RS a E 54 HIG alt Recorder DRZ LEDS o dido cales 54 Connecting a PillCam Recorder to a Personal Computer PC acatar cay unos oo inuaseduleatianusstecnertecameawandeeauaas 56 Connecting a PillCam Recorder to the External REI NIM VIC Weiss 56 Chapter 6 Performing PillCam Capsule EndOSCOpy cococcoccocconconcnoconccnncnncnnonncnnrancnanons 57 Setting Delay First Instruction in PillCam Recorder ccccccssseeseeeeeeeeneeeeeeeneeeeeeenesenes 57 PillCam Recorder Capsule Pairing DR3 ONly occoccconncnnnincnincconccconncnanonanonaronannnnnrnnnnannos 58 Capsule Designation During Patient Check in oocccocncccncocccocncocncocnconnconnnonncnnnoncnoncnnnnns 58 Capsule Designation Before Capsule Ingesti0N occcocccccncocncccncccncoonccnnconncnnnoncnonannnons 59 Capsule IN ESION a a dt 60 PIC am Recorder DAS ea 61 PillGam Recorder DIRZ ii tetuetne cds e a hier Gul alerts a 61 Akter Capsule INGESUUON cxcmateiitsdictin tel amamaanrieresi E tadownieewinde 62 ea Lee ga mal Ud eer eee trie ene teers mere ere ere ene ee nena ere ee ee 62 FUN A tae dae E iat Gene tue cee 62 PIIIC Im GCOLON DRI ONIY witsi22aietent i
36. and the LEDs start flashing e To turn off press and hold the On Off button until you hear a beep and the LEDs turn off NS Note Automatic shutdown After the PillCam recorder has been checked in it goes into a standby mode when removed from its cradle and starts recording as soon as a signal is received from a paired capsule If after 90 minutes no paired signal is received the PillCam recorder automatically shuts down After starting to receive signals from a capsule if there is a gap of 30 minutes of no signal reception the recorder shuts down PillCam Recorder DR2 53 PillCam Capsule Endoscopy 54 Charging The cradle provided with the PillCam recorder DR2 e Charges the PillCam recorder when it is placed in the cradle e Charges a spare battery externally when a stand alone battery is placed in the cradle e Performs battery maintenance by discharging the battery when needed the cradle detects when the battery needs refreshing and automatically discharges it before recharging To charge the PillCam recorder DR2 1 Insert the PillCam recorder DR2 into the cradle 2 Push it all the way down into the cradle and make sure you hear a series of beeps indicating that connection is complete Warning A N Do not connect the PillCam recorder DR2 to the sensor array while the PillCam recorder DR2 is in its cradle There are four connections on the back panel of the cradle Only two of them are used with standard operation of
37. any changes Clicking OK will accept the new settings and close the Settings screen Settings Study Manager Saad da cio CAProgramDataWApplication Data Given Imaging Study Manager ni Display capsule sub type Y Open findings automatically Regimen Settings Regimens Directory Customer Support C S S A Address System Wide OK ME ED Study Manager Section Created user columns in the Study Manager are available for use by other users In the Shared data directory type the desired location of the shared path or click Browse to navigate to it Display capsule sub type also shows the sub type in the Capsule Type column of the Study Manager Open findings automatically when opening a video from the study manager the findings file will open as well if available Regimen Settings Section Displays the Regimen Settings location configured for your system If this needs to be changed type the location of or click Browse to navigate to the desired folder Customer Support Section This section explains how to configure the RAPID software to allow the collection of performance data for analysis by the Given Imaging support department RAPID allows for a one click extraction and sending of RAPID log files for convenient customer support access This enables easier tracking and background information on the RAPID software being used in the RAPID Settings Configuring RAPID Softwa
38. appears in your user profile in Windows RAPID Settings 143 PillCam Capsule Endoscopy As aresult whenever a report is saved printed exported or sent as an attachment by email the following screen appears Electronic Signature Logged in user GIVEN Johns Sign the report as John Smith Password f Don t Sign Enter your login password and click Sign Results Export and Patient Summary Section For both Results and Patient Summary Exports the data can be exported to a drive directory which 1s pre defined in Settings or to a CD Simply check the box Export to directory and type the location to where to export This can be done for both the Results Export and Patient Summary Export The checkbox Include video clips in export data will enable saving clips and images during export Results Export Y Include video clips in export data Y Export to directory CA Browse Patient Summary Export Y Include video clips in export data Y Export to directory CAR A If Export to Directory is left unchecked a screen pops up prompting you to select a location to export each time you export When exporting the results or patient summary a copy 1s also saved locally on the computer Regimen Format Section The Regimen Manager enables two convenient print layout options for the post capsule ingestion instructions The desired default layout can be configured selecting either pocket format or page form
39. be performed either through the check in process in RAPID or directly through the recorder controls before ingestion see PillCam Recorder Capsule Pairing DR3 only on page 58 Real Time Viewing Real time viewing 1s an optional function whereby the images captured by the capsule and received by the PillCam recorder are displayed to the user in real time for review by the physician The PillCam recorder DR2 provides this functionality only in conjunction with a dedicated tablet PC connected to it during the procedure The PillCam recorder DR3 provides Given Imaging 43 PillCam Capsule Endoscopy this functionality both through a dedicated tablet PC but also autonomously by its built in display Appropriate controls on the recorder activate and control the operation of this function Regimen Reminder Regimen Reminder is a reminder function whereby the PillCam recorder alerts the user to perform dietary instructions during a PillCam COLON 2 procedure For more details see Post Ingestion Patient Instructions on page 151 Download Download is the transfer of the stored raw procedure data from the PillCam recorder to the RAPID and the creation of a RAPID video for subsequent review Before you perform your first PillCam procedure make sure that you are familiar with the controls and functions of the PillCam recorder PillCam Recorder DR3 General Due to the limited number of recharge cycles and also due to wear on the electrical connec
40. be printed and handed to the patient after capsule ingestion The reminder numbers on the screen of the PillCam recorder DR3correspond to numbered instructions in the post capsule ingestion patient instructions but the instruction 1s not detailed on the PillCam recorder screen You must print the post capsule ingestion patient instructions for the patient to allow the association of the alerted number with the instruction details To print the Pre capsule Ingestion Regimen Instructions 1 Select the Pre capsule Ingestion tab The relevant screen appears displaying all the regimens or patient instruction templates available 2 Select your item and click Print To print the Post capsule Ingestion Regimen Instructions e Click Print Regimen during the patient Check in stage see Performing Patient Check in on page 24 the patient s details are included in the printout Regimen Manager 153 PillCam Capsule Endoscopy e You can also print out the personalized post capsule ingestion instructions after completing the check in by going to the Study Manager selecting the desired patient and clicking Print Instructions at the bottom of the screen e You can also print out the post capsule ingestion instructions without the patient s details via the Regimen Manager as follows a From the Home screen select Tools gt Regimen Manager b Select either the Post capsule Ingestion tab or the Pre capsule Ingestion tab The relevant screen appe
41. capsule was able to detect a pathological abnormality in 12 60 of the patients whereas enteroscopy detected abnormalities in 7 35 of these patients The 5 patients in whom lesions were found by the PillCam video capsule but not enteroscopy all had abnormalities in the distal jejunum or ileum outside the reach of most standard enteroscopy examinations The average length of insertion during enteroscopy was 2 3 meters Specific findings detected by the imaging system included arterio venous malformations AVMs mucosal erosions and ulcerations and a submucosal tumor In one case 5 though the PillCam video capsule detected a small bowel AVM that was found by enteroscopy one out of the two reviewing physicians did not detect the AVM when reviewing the RAPID video Overall the findings obtained from the PillCam Capsule Endoscopy System and standard enteroscopy agreed in 14 cases 70 The two methods revealed similar pathologies in 6 of these patients Both exams were normal in an additional 8 patients A total of 14 separate small bowel findings were eventually noted in 13 patients by either of the two imaging modalities or by laparoscopic surgery The PillCam Capsule Endoscopy System was able to identify 12 of the 14 lesions 86 while the enteroscopy detected 7 of the 14 lesions 50 Both repeated enteroscopies small bowel x rays and the PillCam video capsule failed to detect an ulcerated Meckel s diverticulum found at surgery Pil
42. cavideo 744 1URU Q 24FeBIN OO CAVideos1744 1 URU _ 24 Feb 11 cavideos 74a 1URUQ 24Feb11 id Browse MEN Save MEN ME Cancel 8 Browse for the CD DVD drive on your computer 9 Type in a volume name for your disc pels Directory Da Browse Volume Name RAPID RAPID Save MET Cancel _ Cancel 10 Click Save A screen appears showing the progress bar and Exporting study When the progress bar 1s full the last screen appears with the message File export successful 11 Click OK RAPID will eject the CD or DVD when the burning operation is complete 12 Write the volume name on the disc Saving a Study to Another Archive The Study Manager allows you to save a study to another archive such as a USB storage device When you connect a USB storage device to one of the USB ports of the computer the Study p Manager treats it as an archive and the icon appears on the left side of the screen ALG Note USB storage devices used for Raw Data Copy or for transport of RAPID videos should be labeled as such stating that it may contain clinical data and should not be used for other purposes 1 Select the relevant study and click Export The Export Study screen appears 2 Select either Entire study or Specific files under Select data to export If you select Specific files a window opens inside the screen showing the files you can select 3 Ifyou wish to de identify the video in the study select t
43. check is selected by default Un check to disable spell check Enable Gl Dictionary is selected by default Un check to disable the GI Dictionary Open the Full name format list and select the desired name format SN n p p Click Apply to accept the new settings or click Cancel to close the Settings screen without making any changes Clicking OK will accept the new settings and close the Settings screen To change the unit of measure 1 From the Home screen select Tools gt Settings The Settings screen appears 2 Under the General tab in the Regional Settings section open the Measurement Units list and select the desired measurement system 138 RAPID Settings Configuring RAPID Software 3 Click Apply to accept the new settings or click Cancel to close the Settings screen without making any changes Clicking OK will accept the new settings and close the Settings screen Permissions Section Enables the system administrator to specify a list of local or domain user groups that are allowed to open RAPID To specify a user group for RAPID 1 From the Home screen select Tools gt Settings The Settings screen appears 2 Under the General tab in the Permissions section type in the user group you wish to allow access to RAPID The domain must be entered in this format lt domain name gt lt group name gt lt local group name gt lt next group gt This feature is enabled only if System Wide Settings check box 1s sele
44. click on the Identify button the corresponding PillCam recorder s LEDs blink e The relevant patient information is displayed on the Recorder bar e PillCam recorder s last use is displayed The Manage video data Create video and Check in patient buttons become available 4 Click Manage video data x f Copy to path Change eldatatranster Copy to external device GA start Copy Cancel 5 Select the location for the copied data Managing RAPID Video Data 71 PillCam Capsule Endoscopy 72 Click Change if you wish to copy the data to a different location on the computer network or external device than the default E datatransfer To change the default directory see Video Data Management Section on page 140 6 Click Start Copy During raw data copy the Recorder bar displays Compiling raw data or Copying data depending on the video settings Status and progress bar Patient name ID Name of the video to be created Battery status The text Do not remove PillCam recorder flashes below the battery status until all data is copied Once the process is complete a message appears on the screen notifying you that the data copy is complete The PillCam recorder may be disconnected at this point Managing Data Files The Raw Data Files screen allows you to manage and monitor all video data files on your PC or connected USB storage device To open the Raw Data Files screen select Recorder Download from
45. click the thumbnail and select Compare Thumbnails A separate window appears showing the same thumbnail duplicated side by side AA On Of FICE1 FICE 2 FICE 3 Blue On Gif FICE1 FICE2 FICE3 Blue 3 Use the Image Adjustment tools at the top of the window of one of the thumbnails to compare the two images COE ee On Of FICE1 FICE2 FICE 3 Blue On Off FICE1 FICE2 FICE3 AS Note You can scroll through the video by moving your mouse wheel in either direction Both sides will move together To compare two images in the same video 1 Click the first thumbnail you wish to use for comparison Using RAPID to View a Video 113 PillCam Capsule Endoscopy 2 Hold down the CTRL key on your keyboard and select the second thumbnail 3 Right click either one of the selected thumbnails and select Compare Thumbnails A separate window appears showing both thumbnails side by side momo Se es eae On Gif FICE1 FICE2 FICE 3 Blue On O FICE1 FICE2 FICE3 Blue 00 25 51 AL Note You can scroll through the video by moving your mouse wheel in either direction for each thumbnail separately RAPID Video Files 114 A RAPID study 1s the collection of files associated with a specific PillCam Capsule Endoscopy procedure A RAPID study is contained in a folder that contains the RAPID video file The gvi file and the RAPID study name consists of several elements separated by spaces The components are der
46. contact your IT system administrator Electronic signature failed Please contact your IT system administrator You do not have permission to access the Regimen Manager Please contact your system administrator Patient Check In procedure failed Reason failed to update PillCam Recorder Troubleshooting Solution In order to enable electronic signatures in CE report the user s relevant Windows account must have defined the full name field full name will appear in electronic signature In order to enable electronic signatures in CE report the user s relevant Windows account must be enabled for remote connection login Possible reason for this error message include e Password Expired e Account Restrictions e Invalid Logon Hours e Account Lockout or expired or disabled Password must be changed In order to allow physicians to edit and approve their regimens the following must be done In the Setting screen under the Other tab the Regimens Directory must be defined to an existing folder This folder must be open for read and write permissions for the relevant users Turn the recorder off and then on before the next check in attempt If the upgrade fails again contact customer support For LED behavior see LED Display on page 48 For Error messages displayed on the PillCam Recorder screen see Error Messages on page 52 Low Signal If a low signal is detected during the examination the following mes
47. each thumbnail then need to redefine it in this screen Creates jpeg s as well as mpeg clip s of the selected thumbnail Using this feature will create a jpeg image of each selected thumbnail and a video clip surrounding the selected thumbnail The number of images used in creating a video clip from a selected thumbnail is determined in Image Data settings described above The images and clips are saved to a selected directory Creates a video clip from the first selected thumbnail to the last selected thumbnail This feature is enabled only if at least two thumbnails are selected Video clips can be viewed in Windows Media Player Generating a Report Button Ha Save Video Segment Save Joined Segments LT Compare Thumbnails Reviewing and Interpreting RAPID Videos Function Creates a short RAPID video segment from the first thumbnail to the last thumbnail selected Video can only be viewed with RAPID software The segment is saved in a folder with a copy of the findings file Feature is enabled only if at least two thumbnails are selected Joins RAPID video segments created from selected thumbnails Video can only be viewed with RAPID software The segment is saved in a folder with a copy of the findings file Enables comparing of a thumbnail to itself in different display modes i e FICE or Blue mode or comparing of two different thumbnails in the video Refer to Comparing Thumbnails on page 112 for more
48. emission requirements Cautions A caution indicates a condition that may damage the equipment Cautions Make sure that only trained personnel familiar with all of the PillCam Capsule Endoscopy System operating procedures use the system Endoscopic video capsule placement requires skill and experience in endoscopic esophageal intubations with an accessory device seated at the distal tip of the endoscope Use of the device is not recommended if the clinician lacks the required experience and proficiency Use the system only with components purchased from Given Imaging Ltd Use of other components including power supply for the cradle may damage the system and void the watranty Occasionally some images may be lost resulting in video gaps due to radio interference e g from amateur radio transmitters RFID radio frequency identification systems MRI fire station police station etc This may result in the need to repeat the Capsule Endoscopy procedure In such a case advise the patient to stay within the premises of the clinic for the duration of the second Capsule Endoscopy procedure to prevent this problem from recurring In a small number of cases the PillCam SB capsules used for Small Bowel Capsule Endoscopy may not image the entire small bowel due to variations in patient GI motility Similarly the PillCam COLON capsule used for COLON Capsule Endoscopy may not image the entire large bowel colon due to variations in pati
49. for an ESO procedures The cradle has the following LEDs ee rearorao Blinking discharging Red fon faulty malfunctioning To charge the PillCam recorder 1 Plug the power cable into the cradle and plug the power cable into the wall outlet All three LEDs turn on for a self test that takes 5 seconds After 5 seconds all LEDs turn off and the cradle is ready for use If during the self test the red LED blinks the cradle is faulty Contact Given Imaging Customer Support 2 Insert the PillCam recorder or its Li Ion battery with its adaptor into the cradle All three LEDS of the cradle blink for 4 seconds When the orange LED is on charging has started As soon as the PillCam recorder or its battery pack are fully charged the green LED turns on and the orange LED turns off 3 Leave the PillCam recorder in its cradle until the next examination PillCam Recorder Maintenance 165 PillCam Capsule Endoscopy 166 4 To check the status of the PillCam recorder before an examination remove it from the cradle and push the button on the back Manual Discharge If the cradle detects that the battery needs refreshing it automatically discharges the battery before recharging it The orange LED on the cradle blinks during discharging Discharging 1s an overnight process that may take up to 12 hours We recommend that you manually discharge the battery every three months even if it 1s not used To discharge the batter
50. for confirmation of the deletion ZG Note Deleting a study in the Study Manager deletes all data including procedure videos from the source directory This cannot be undone Using the Study Manager 87 PillCam Capsule Endoscopy Offline Studies The Offline studies screen displays information about studies stored on removable storage media such as CDs DVDs and some USB storage devices that have been connected to the computer during use of RAPID and are currently disconnected from the computer It allows you to browse for studies in archives which are currently not connected to the computer The offline study list is updated when the removable storage media is disconnected or reconnected A reconnected study no longer appears in the Offline Studies list Once reconnected the removable media containing the study is displayed in the left side of the Study Manager screen Preexisting studies will appear in the Offline Studies list only after they have been connected and then disconnected from the computer during use of RAPID Offline studies information includes the Volume name and Volume type or kind of media Volume names for CDs and DVDs are allocated at the time the disc is burned For USB devices a unique name rather than the name designated by the manufacturer must be allocated before use In order to be able to locate a desired study be sure to mark the disc or other media with its volume name To access an offline study
51. of the PillCam Capsule Endoscopy System Cautions 178 Do not use or subject the battery pack to intense sunlight or hot temperatures such as in a car in hot weather Otherwise acid leakage overheating and or smoke emission can occur Also its guaranteed performance will be lost and or its service life will be shortened The battery pack incorporates built in safety devices Do not use it in a location where static electricity greater than the manufacturer s guarantee may be present Otherwise the safety devices can be damaged possibly leading to acid leakage overheating smoke emission bursting and or ignition The guaranteed recharging temperature range is 0 C to 45 C A recharging operation outside this temperature range can lead to acid leakage and or overheating of the battery pack and may cause damage to it If acid leaking from the battery pack comes into contact with your skin or clothing immediately wash it away with running water Otherwise skin inflammation can occur For recharging procedures refer to Charging on page 46 If you find rust a bad odor overheating and or other irregularities when using the battery pack for the first time return it to your supplier or vendor Cautions System Specifications Note D JS Technical Description Specifications are subject to change without prior notice and without any obligation to users on the part of the manufacturer e Specifications are rounded
52. one physician uses this installation of RAPID select Clear physician name when a new video opens If selected you can manually enter the physician name for each video when needed 4 In Facility Details type in the facility information for example address and telephone number 5 To add your facility s logo to reports click Change Logo a Navigate to the logo file jpeg image you previously saved on your computer and select the file b Click Open to set the file as the report logo c To clear the selected logo and prevent any logo from appearing on the report click Clear Logo NS Note The Logo used in the report is copied to a RAPID directory The original is not affected 6 Click Apply to accept the new settings or click Cancel to close the Settings screen without making any changes Clicking OK will accept the new settings and close the Settings screen Regional Settings Section By default the RAPID software is set to English and uses metric units of measure You may change these settings To change the language 1 From the Home screen select Tools gt Settings The Settings screen appears 2 Under the General tab in the Regional Settings section open the Language list and select the desired language Regional Settings English ng 4 Enable spell check 4 Enable GI Dictionary Language Measurement units Metric cm Kg Ww Full name format First Middle Last hd Enable spell
53. one red or bleeding lesion found by a physician on capsule endoscopy the SBI feature correctly marked 439 or 88 of the 498 individual lesions In addition a total of 561 false positive lesions were marked by the feature giving a positive predictive value PPV of 44 Accuracy of the Device SB 9 PillCam Capsule Endoscopy Accuracy of the Device ESO The PillCam Capsule Endoscopy System with the PillCam ESO capsule was studied in a series of 107 subjects included in the study Among patients included in this clinical study 94 subjects had suspected GERD at the time of the study and a small group 13 subjects were diagnosed with Barrett s prior to the study All patients underwent esophageal capsule endoscopy as well as esophagoscopy to compare the results of the esophageal capsule endoscopy with conventional video EGD imperfect standard in assessing endoscopic findings of the esophagus Rate of Agreement 95 Cl Esophagitis 85 69 95 Suspected BE 81 62 94 Normal 70 53 83 OVERALL Rate of False Pos 95 Cl 13 4 27 15 6 30 Rate of False Overall Neg 95 Cl Agreement 95 Cl 12 3 27 15 4 34 78 3 69 86 The study was too small to accurately assess the agreement with lesions other than the most common findings esophagitis and suspected Barrett s esophagus There were several other lesions which were noted as depicted in the table below
54. pairing the Delay First Instruction icon will disappear and the status will not be changeable any more Delay First Instruction on F a 12 35 AFR fA som smm Ej 12345 P COLONZ 1234567 q Given Imaging 57 PillCam Capsule Endoscopy PillGam Recorder Capsule Pairing DR3 only 58 PillCam recorder DR3 operates only with capsules that were paired to it This allows the PillCam recorder to recognize images from the correct capsule Pairing is initiated when the PillCam recorder recognizes transmission from a designated capsule From that point on the recorder is associated with the capsule The recorder and capsule are then paired Warning A N The PillCam recorder starts recording only after it is paired with the capsule f pairing is not complete no video can be produced Make sure you see the Pairing Success icon g on the screen and the capsule LED on top of the recorder blinking in BLUE before capsule ingestion Designation of the capsule to be used in the procedure may be performed during patient check in or immediately before capsule ingestion The following section describes these two scenarios Capsule Designation During Patient Check in While entering the patient and procedure data during check in type the capsule ID in the Capsule ID field or use a barcode scanner The capsule ID is displayed on the capsule package Capsule ID XXXXXXL DALH EESE A 123 ABC 1
55. performing registration The Home screen appears RAPID sica Patient Check in Recorder Download iB View Study Cu a a GIyEN IMAGING ALG Note RAPID workstation only the Computer Locked screen appears whenever the workstation is idle for more than half an hour Only two users can unlock it e the user who was logged in when the RAPID workstation went into Autolock by entering the appropriate password or e the system administrator Starting RAPID for the First Time Appendix A2 Configuring RAPID Software Single or Multi user Setting When RAPID 1s installed in a network environment you can limit the access to RAPID to a group of authorized users The system administrator must first set up a network group with all the authorized users Once this is done you must set up RAPID to enable only the users from this network group to use RAPID To enable access to other RAPID users 1 From the Home screen select Tools gt Settings RAPID sica Patient Check in J U Recorder Download y E View Study Pilca Atlas aie User Dictionary System Wide Settings gt GIyEN Y IMAGING The Settings screen appears 2 Under the General tab in the Permissions section check RAPID users must belong to this network group and type in the network group 3 Click Apply to accept the new settings or click Cancel to close the Settings screen without maki
56. presence of pathology and if symptoms persist further evaluation should be performed e If intestinal fistulas strictures or stenoses are suspected or the patient has had prior abdominal or pelvic surgery the physician should consider performing a procedure to ascertain patency for an object the size of the PillCam video capsule e A thorough understanding of the technical principles clinical applications and risks associated with the PillCam Capsule Endoscopy System is necessary before using this product Read the entire manual before using the system for the first time e To prevent the patient from being exposed to unforeseen risks during passage of any PillCam video capsule make sure the patient thoroughly understands the procedure and provide the patient with a copy of the Patient Instructions e A patient with known or suspected delayed gastric emptying whether disease related or drug induced could be at increased risk for incomplete PillCam capsule endoscopy of the small bowel or colon e If there is reasonable doubt concerning the integrity of the PillCam video capsule due to dropping biting or any other eventuality the capsule should be deactivated by returning it to its box and it should not be used until consulting with an authorized Given Imaging representative e In patients with unsuspected strictures of the GI tract any PillCam video capsule can potentially cause intestinal obstruction resulting in the need for hospi
57. process that enables minimally invasive visualization of the GI tract using an ingestible video capsule The video capsule captures images that are later presented to the physician for review and interpretation The PillCam Capsule Endoscopy Process The PillCam capsule endoscopy CE process consists of the following steps e Preparing the patient and the system for the ingestion of the capsule e Performing the capsule endoscopy procedure e Video creation e Video review and interpretation PillCam Capsule Endoscopy System Components The PillCam capsule endoscopy CE system components that support the PillCam capsule endoscopy process consist of the following e PillCam capsules which acquire pictures of the gastrointestinal tract and transmit them to the PillCam recorder e PillCam recorder with PillCam sensors which receives and stores the images collected during the procedure for subsequent video creation with the RAPID software e RAPID software which processes and transforms the raw image data stored in the recorder into a conveniently viewable RAPID video and allows review of the RAPID video PillCam Capsules PillCam capsules are video cameras designed specifically for imaging the intestinal tract Each capsule 1s equipped with a tiny battery a transmitter with antenna and LEDs light emitting diodes for each video camera head These components are enclosed in a biocompatible plastic casing A capsule is about the size of a
58. recorder DR2 all battery LEDs should light up 3 e For PillCam recorder DR3 the battery icon on the screen should be 0 3 Insert the PillCam recorder into 1ts pouch Instruct the patient to keep wearing the PillCam recorder during the examination DR2 DR3 The pouch or belt is ready and the patient can wear it Fitting Equipment on the Patient 39 PillCam Capsule Endoscopy Warning A N When a PillCam recorder is connected to a sensor array worn by a patient e Do not connect the PillCam recorder to a computer that is connected to an electrical outlet e Do not put the PillCam recorder into a cradle or connect it to a charger e Attach the sensor connector to the PillCam recorder immediately prior to capsule ingestion e PillCam recorder DR3 only make sure that the connector component is placed between the patient s body and the PillCam recorder DR3 waist strap e PillCam recorder DR2 only if the blue LED is blinking before you open the PillCam capsule box reinitialize the PillCam recorder Positioning PillCam Recorder DR3 1 Make sure the PillCam recorder is on navigation button LEDs blink once every 5 seconds 2 With the patient standing hang the pouch from the patient s left shoulder to the right hip sj 3 Insert the sensor connector into the PillCam recorder s slot until you feel and hear a click If the sensor is not properly connected to the recorder Pp appears on the PillCam recorder scr
59. show the A Pa mode Automatic video created for all PillCam SB2 as well as for all PillCam SB3 with PillCam recorder DR2 procedure videos M mode Review mode This button sets the review mode to show the M mode Manual video created sequentially from all captured images Pug for PillCam SB2 as well as for all PillCam SB3 with PillCam recorder DR2 procedure videos if creation of M mode video is enabled in Settings By default creation of manual mode video is disabled during download To enable manual mode see Video Creation Section on page 140 Viewing Layout Group This ribbon group contains tools for customizing the video display from one video head Single Dual Quad and Mosaic view The tools maximize reading efficiency by simultaneously displaying consecutive images in one easily viewed image JA Note Dual and Quad views are available only when viewing the video from one video head that is from one end of the capsule Button Function Single view Shows the video in Single view one single frame on the screen Dual view Shows the video in Dual view which displays two STE consecutive frames side by side at the same time Frames 1 and 2 then frames 3 and 4 then frames 5 and 6 etc This is different than dual head capsule videos that display a single frame from each of the two capsule heads simultaneously side by side Quad view Shows the video in Quad View which displays four consecutive frames The order of the i
60. summary a copy of the report is also saved locally on the computer The checkbox Include video clips in export data will enable saving clips and images during export Markings Buttons Group This ribbon group contains tools for marking the selected thumbnails When viewing a procedure video the Thumbnail Editor enables marking and annotating of selected thumbnails The Markings buttons group in the Report tab enables deleting a thumbnail and marking already created thumbnails during the Preview and Review stages Refer to Marking Tools on page 107 for complete instructions on marking thumbnails Button Function de Creates a circle around an area of interest ha Fa Creates arrow pointing to area of interest E Enabled only for COLON 2 procedures Polyp Size Estimation PSE tool Tool for estimating the size of a suspected polyp after boundaries are marked and displays the results on the thumbnail next to the polyp Polyp Size Estimation is a tool for research purposes only and the values generated should not be used in making diagnostic or treatment decisions 120 Creating a PillCam Capsule Endoscopy Report Reviewing and Interpreting RAPID Videos Button Function En For ESO procedures only Activates Circumference Scale Displays circular grid to estimate the circumferential involvement of suspected pathology such as esophageal varices see Circumference Scale on page 107 va Undoes last graphical marking made on the thu
61. that the patient knows which activities to avoid during the procedure and how to return the PillCam recorder and sensors PillCam Recorder DR3 The procedure ends when the End of Procedure screen appears on the PillCam recorder The PillCam recorder also beeps and vibrates and shuts down automatically five minutes after appearance of the End of Procedure icon PillCam Recorder DR2 The procedure lasts as long as the blue PillCam recorder LED is blinking or until the capsule 1s excreted The PillCam recorder DR2 LED should blink for at least six hours unless the PillCam SB capsule was excreted JRK Note When the capsule LED on the PillCam recorder blinks orange this indicates that the PillCam recorder is no longer receiving capsule signals PillCam COLON DR3 only After ingestion explain the Patient Guidelines see General Patient Guidelines During the Procedure on page 23 to the patient Explain to the patient what to do when the PillCam recorder beeps or vibrates see Post Ingestion Patient Instructions on page 151 62 After Capsule Ingestion Performing PillCam Capsule Endoscopy Real Time Viewing with PillCam Recorder DR3 Only Internal Mode To activate real time viewing with PillCam recorder DR3 press the middle navigation button below the Real Time icon then immediately press the left and right buttons one after the other The following screen appears on the PillCam recorder F 8
62. the Home screen The Procedures screen appears Select the Raw Data Files tab A list of raw data files appears their status and location are displayed in the recorder bar On the right side the following buttons appear Button Action Creates a video from the video data file that was copied to the computer Deletes the video data file that was copied to the computer Managing RAPID Video Data Creating RAPID Videos Button Action Copies the video data file to a CD DVD to a different folder or a USB storage device Ejects the USB device once the video data file is copied and deleted from a USB storage device This button appears only if raw data files are connected to the computer via a USB device ALG Note Label all USB storage devices used for Video Data Copy or for transport of RAPID videos stating that they may contain clinical data and should not be used for other purposes Batch Data Copy RAPID software can perform multiple video data copy for any combination of up to four PillCam recorder cradles and USB storage devices and for any number of video data files From PillCam Recorders Place PillCam recorders into the connected cradles In the Recorders screen click Manage video data for each one separately From Video Data Files USB Storage Devices Connect USB Storage devices In the Raw Data Files screen click Copy file for each one of the devices or any video data files already on the co
63. the cradle the power connector and the USB cable connection The cradle also connects the PillCam recorder to the Personal Computer PC e The green LED on the cradle indicates that the PillCam recorder DR2 is fully charged and ready for use e The red LED when lit continuously indicates a defective battery e The red LED when blinking indicates that there is a problem with the cradle PillCam Recorder DR2 LEDs When the PillCam recorder DR2 is on it starts recording as soon as it receives a signal from a PillCam capsule When the capsule LED blinks the PillCam recorder DR2 is receiving data When the signal from the PillCam capsule is too weak the LED does not blink Recorder LED Capsule LED PillCam Recorder DR2 Know Your PillCam Recorder These are the LED indicators and their statuses and colors for the most common PillCam recorder DR2 events and statuses LEDs PillCam Recorder DR2 Status i i PillCam recorder is ON but not initialized PillCam recorder does not capture capsule signals 7 i PillCam recorder is initialized with patient data and ready to capture capsule signals PillCam recorder shuts down if no capsule signals are received for more than 30 60 or 90 minutes depending on the PillCam recorder software version i i PillCam recorder is exchanging status or data with RAPID or RAPID RT lt j gt y LED blinking rate varies according to the communication flow i PillCam recorder is capturing capsul
64. the electromagnetic environment specified below The customer or the user of the PillCam capsules should assure that it is used in such an environment Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 6 kV contact 6 kV contact 8 kV air 8 kV air 2 kV for power supply lines Not applicable 1 kV for input output lines 1 kV line s to line s Not applicable 2 kV line s to earth lt 5 Uy gt 95 dip in Uy for 0 5 cycle 40 Uy 60 dip in Uy for 5 cycles 70 Uy 30 dip in Uy for 25 cycles lt 5 Uy gt 95 dip in Uy for 5 sec Not applicable Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Not applicable Not applicable Not applicable Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Uy is the AC mains voltage prior to application of the test level Guidance and Manufacturer s Declarations 191 PillCam Capsule Endoscopy Guidance and manufacturer s declaration electronic emissions The PillCam capsules are intended for use in the electromagneti
65. to be charged with an extremely high current and voltage and as a result abnormal chemical reactions can occur in it possibly leading to acid leakage overheating smoke emission bursting and or ignition To recharge the battery pack use the PillCam recorder cradle and observe the recharging conditions A recharging operation under non conforming recharging conditions higher temperature and larger voltage current than specified modified battery charger etc can cause the battery pack to be overcharged or charged with extremely high current abnormal chemical reaction can occur in it possibly leading to acid leakage overheating smoke emission bursting and or ignition Do not pierce the battery pack with a nail or other sharp objects strike 1t with a hammer or step on it Otherwise the battery pack will become damaged and deformed internal short circuiting can occur possibly leading to acid leakage overheating smoke emission bursting and or ignition Do not strike or throw the battery pack The impact might cause leakage overheating smoke emission bursting and or ignition Also if the protective feature in it becomes damaged it could become charged with an extremely high current and voltage abnormal chemical reactions can occur which can lead to acid leakage overheating smoke emission bursting and or ignition Do not use an apparently damaged or deformed battery pack Otherwise acid leakage overheating smoke emissio
66. where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people PillCam COLON 2 Capsules Guidance and manufacturer s declaration electromagnetic emissions The PillCam COLON 2 capsules are intended for use in the electromagnetic environment specified below The customer or the user of the PillCam COLON 2 capsules capsule should assure that it is used in such an environment The PillCam COLON 2 capsules use RF energy only for its internal function Therefore its RF RF emissions a emissions are very low and are not likely to CISPR 11 cause any interference in nearby electronic equipment RF emissions The PillCam capsules are suitable for use in all establishments including domestic IEC 61000 3 2 establishments and those directly connected to the public low voltage power supply network that Voltage fluctuations O ene supplies buildings used for domestic purposes flicker emissions Not applicable IEC 61000 3 3 Guidance and Manufacturer s Declarations 193 PillCam Capsule Endoscopy Guidance and manufacturer s declaration electromagnetic immunity for all equipment and systems The PillCam COLON 2
67. yi E PERD Sy F Srl Hyi EE apii ip al gi a BRET ee piy pa Le x MAGU JO GUS par am aag Tam NS a A Fold the bottom part of the printout first Regimen Manager Npa a Bung 155 PillCam Capsule Endoscopy Print in Page Format When enabled the post capsule ingestion instructions will be printed on a page layout displaying all information on one page ul INSTRUCTION GUIDE E eee eee a FE Fa 3 A EA BAO al G Ing rctom During Yow Pilm a PUE DE we guns Procedure Ja ESTA CERA E PO PRT ate E ferergo ura rar ert Pret AA rea ENTER oe BAAS Nao Pood Ce TOGA Nee CTAA Oe la a eee en ee Pa PO Ah A EA PF M Seer A pe ra TIA LOCA Bano MEE Ae TRATO oe E A eete over Fe Age Aor Powders bee ors Rewer menaa rera e cen mui Te AA outst naa o A ig a CoA PLANS NUEG PERE IA A mi de MATTAS N a eA BLALC puec STON TAMU te bararo E Eo A paa r a ote ay eet gt ee Y digo cece Meme emise i e a a Mo a mm dere e apo Sandor Removal Kay ene a fated etl ia a ee Sed of Peace pe om ike a Acad AMI ed ee Ri ed ee es pl beet Brees g Re epi Erro eli Hens A eee eri eee De el pal Ae aes g wre Da ate lo Pe nanmi i Are Ape bel egy wes ee E Adarmonal insinuations ier MO ee pe ha eee ade in a pa b rl a lira A appa See ae cade comely fete a AA Pao E Maio le de ee py ee ee ee alee psu A tee cle eee ee been AN Warming Fra z ei Ar AA pa pom YEAS PON yal ao
68. 162 Key Space Left arrow Right arrow Page Down Page Up Home End Enter Control T Control M Control N Control S Control O Control R Control P Control 1 Control Shift S Control Shift D Control Shift Q Control Shift M Control Shift C Control Shift 1 2 3 Control Shift B Control Shift N Control mouse wheel up down Operation Play Pause Video Go to next image Go to previous image Go 10 images forward Go 10 images backwards Go to first image Go to last image Capture Thumbnail Show Atlas Show Study Manager Open Video Save Findings Open Findings Report Preview Report Print Image Enhancement set View Layout to Single Set View Layout to Dual Set View Layout to Quad Set View Layout to Mosaic Set View Layout to Collage Image Enhancement FICE 1 2 3 Image Enhancement Blue Image Enhancement Normal Decrease Increase video Viewing Speed Keyboard Shortcuts Appendix A3 PillCam Equipment Maintenance PillCam Recorder Maintenance Use only a fully charged PillCam recorder In general including first time use charging the PillCam recorder 1s an overnight process and should not be performed in the vicinity of the patient When you receive the PillCam recorder after an examination charge it immediately until the green LED 1s lit and leave it in its cradle A lt y yN Warning Charge the PillCam recorder only with the supplied cradle Once you have
69. 3 20 First Esop First Gast Localization Progress indicator Thumbnail Thumbnails navigation buttons Report Ribbon The Report ribbon is divided into several groups enabling many different functions The buttons and commands are organized in the following logical groups e Configure e Report e Image Data e Markings e Clinical Tools SE la a o E RAPID PillCam SB Physician Dr Schnaider _CRT ID 194 1 07 Jan 09 Sl eS File View Report dd Template Image M L 2 Select All Thumbnails pP R R p 3 By Save Video Segment O Circle Circumference Grid et Ma Unselect All Thumbnails pa Uf R ees D gy Save Joined Segment Arrow i de be Ea De Identify Preview Print Save Save Sendas Export SaveClips _ e 4 gt Atlas Lewis Select Current Thumbnail As Attachment Images L Compare Thumbnails PSE Delete Thumbnail Score Configure 5 Report Image Data Fa Markings Clinical Tools Configure group Report group Image Data Marking Clinical Tools group group group In this chapter the groups will be explained in a different sequence than how it appears in the software in order to closely match the proper workflow that is used when interpreting the data Configure Buttons Group The Configure group enables the selection of templates for report generation the ability to de identify patient information and to select deselect all thumbnails Creating a PillCam Capsule Endoscopy Report 117
70. 434 1 MHz 3 2 MHz MSK 8 8 4 fps Total 9 1 hours Resistant to dissolution in pH 2 to pH 8 Silver Oxide batteries 20 40 C 0 30 C System Specifications PillCam COLON 2 Capsule Properties Physical Optical Operational Uplink communication Downlink communication System Specifications Dimensions Weight Material of optical heads Illumination Field of view Effective visibility Min detectable object Operating time Chemical safety Battery type Operating temperature Band width Storage temperature Operating frequency Frame rate Data rate Modulation type Effective radiated power Operating frequency Receiver Bandwidth Technical Description Length 31 5 mm Diameter 11 6 mm 2 9 gr Biocompatible plastic 2 4 white light emitting diodes on each side 172 ISO 8600 3 Distance 3 cm At least 0 1 mm Minimum of 10 hours Resistant to dissolution in pH 2 to pH 8 Silver Oxide batteries 20 40 C 3 2 MHz 2 7 Mbps 6 5 MHz 5 4 Mbps 0 30 C 434 1 MHz 4 35 fps 2 7 Mbps and 8 1 Mbps MSK Digital data 48 8 dBm 13 6 MHz 150 KHz 185 PillCam Capsule Endoscopy 186 Sensor Array PillCam Recorder DR2 Versions SB COLON ESO Reception antenna Sensor size Color Material SB COLON sensor array ESO sensor array Diameter 40 mm Black Plastic 8 sensor elements 3 sensor elements Sensor Array PillCam Recorder DR3 Properties R
71. AFR icon two hours after ingestion you can monitor the capsule location in the GI tract using the real time viewing The system will activate by default the AFR mode and instruction 1 at 4 hours post ingestion at the latest If you need to verify after instruction 1 on the PillCam recorder screen that the capsule has left the stomach use the real time viewer e If capsule is still in the stomach repeat real time viewing to check capsule location every 30 minutes until you can confirm that it has left the stomach e Ifyou visually confirm that the capsule has left the stomach while the AFR indication in the top right corner of the status line still hasn t changed to AFR press the right navigation button under the AFR icon AFR at the right bottom of the screen for 5 seconds This triggers instruction 1 and activates recording mode AFR frame rate The AFR icon AFR appears at the top right corner in the status line of the screen The video created from this procedure will start at this point The mark icon ad will appear above the right navigation button instead of the AFR icon e Once instruction 1 occurs the PillCam recorder automatically continues to provide instructions according to the post ingestion regimen selected during check in JAS Note For COLON procedures e Ifthe PillCam recorder does not detect that the capsule has entered the small bowel either automatically or by the manual procedure described in step 2 above t
72. CD for later use The Report ribbon enables the following functions to prepare the patient report and complement the patient study Add additional thumbnails and study comments Add markings circles and arrows around lesions for emphasis and size estimates to all thumbnails Add comments to all thumbnails Save images and create video clips for later use in presentations or referrals Use the Atlas or Lewis Score clinical tools in the Report ribbon for diagnostic comparison or evaluation using a scoring index Generate a patient report that can also be printed and emailed Export the results or patient summary Creating a PillCam Capsule Endoscopy Report Reviewing and Interpreting RAPID Videos Comments Editor thumbnail or entire study Selected thumbnail m ae A x lt 1 E El 4 oe ES RAPID PillCamSB Physician Dr Schnaider _CRT ID 194 1 07 Jan 09 o ESAS A IE me Tefnplate Image M L 2 Select All Thumbnails P AR IR E P By Save Video Segment O Circle Circumference Grid 92 Unselect All Thumbnails Ey Save Joined Segment Z Arrow A s Del Identify Preview Print Save Save Sendas Export Save Clip N pe Atlas Lewis E Select Current Thumbnail VE AR oS Images 5 Comi abnails PSE Delete Thumbnail Sars Configure Fa Image Data z i Clinical Tools l a Thumbnail Comments Comment Enter your comment here e 00 05 32 00 25 51 00 42 33 00 5
73. Cam COLON 2 capsule and the appearance of the AFR status icon in the right corner of the status line at the top of the PillCam recorder DR3 display The appearance of alert 1 can be designated to appear either an additional 0 minutes or 15 minutes after original tentative alert 1 timing Alert 0 will not occur if alert 1 was raised before it e The End of Procedure EOP alert occurs when no more capsule images are received by the PillCam recorder or enough time has elapsed in the procedure This may occur several minutes after capsule excretion or after the capsule battery was depleted without excretion in a long procedure In general additional alerts and instructions can be inserted between alert 1 and the EOP alert to reflect the physician s preference for post ingestion instructions in a PillCam COLON 2 procedure These instructions can be entered and edited saved and approved through the Regimen Manager and be made ready to be selected in the Check In for a PillCam COLON 2 procedure ANG Note Alert times are designated by the PillCam recorder and the RAPID software In rare cases short delays may occur To Print the Patient Instructions You may need to print both types of Patient Instructions for the patient e The pre capsule ingestion instructions need to be handed to the patient 1 or 2 days prior to the ingestion and are needed for proper preparation of the patient for the procedure e The post capsule ingestion instructions need to
74. Cam Sensor Array For mild cleaning dirt sweat wipe the sensors gently with alcohol wipes up to 70 The alcohol will not remove the adhesive Use alcohol sparingly and allow the sensor array to dry for 20 minutes To remove adhesive from the sensor array not from the human body use white benzene Warning A N Use white benzene only in a well ventilated area according to all precautions and instructions on the label Alternatively use one of the following medical adhesive removers to remove adhesive e B 508 Secure Solvent e B 202 Hollister Solvent e B 206 Detachol Adhesive Remover Use all precautions as defined by the manufacturer Cleaning the Recorder Pouch To clean the recorder pouch wipe down all surfaces with alcohol 70 isopropyl or ethyl alcohol making sure that all surfaces are exposed to alcohol for at least 1 minute PillCam Sensor Maintenance 167 PillCam Capsule Endoscopy 168 PillCam Sensor Maintenance RAPID Video Problem Short video Gaps Bad image quality Video shorter than capsule operating time without either ingestion phase images or body exit images No Localization Cannot open RAPID Atlas Cannot view COLON2 video using RAPID v 7 Cause Capsule PillCam recorder battery PillCam recorder mishandling Capsule Interference Mishandling Physiological Stripes in video Pixilation confetti Dark red orange image Capsule PillCam recorder battery Interference Malfuncti
75. D software clears previous raw data files it may have copied to the computer in the video creation process However if you select the optional Copy raw data method for video creation in the Settings screen raw data files are not automatically deleted after the video is created As multiple raw data files can rapidly fill your disk you must manually clear raw data files as follows To clear raw data files 1 From the Home screen click Recorder Download and select the Raw Data Files screen 2 To confirm that you no longer need a raw data file you can refer to the Last Use status and you may delete files after Successful video creation or data copy 3 Click the bar displaying the file you wish to delete and click Delete file Backup System Logs The system log file records all system events on the Workstation such as log in print delete etc The size of this file is limited and when it reaches 80 of its capacity the following message is displayed immediately after logging in The log files need to be backed up Please notify RAPID Workstation administrator Only the system administrator can back up the system log This message appears at every login until the backup procedure is performed CD DVD Burning The Export function in the RAPID software allows you to save a study or one of its files in a different place or under a different name 1f needed to reorganize your archives This includes e Saving a study or a file to anoth
76. Editor o coocccnccnncnnocnnncnnncnnnon 106 thumbnail create ocooccnccnccnccnnccnccnononacnns 103 thumbnail View ooocooccnccncccccnnncnccnononacnnss 103 PUTO HAIG adn 103 thumbnails scroll through ooommom oo 104 thumbnails Status exck sesssenceiatvosseseewaaveones 104 two thumbnails comparison cccceeeeees 113 U WICETATIONS cd rl ans 8 Undo Mark dont abot rahe le bellos deditos 107 update patient details oooonncnnnnonnnnnnnommm s 32 update PillCam recorders ocooccoocnoncoccncn 25 USB Storage device nia 69 USC CV ClES DR ide 53 User Coline siii 82 User Dictionary id 17 V video creation batch oocooccoccccccocnnccnncno 70 VCO GIDS A EATE EE 7 video segment ii is 129 VIEW avd so EN 99 View ody A 16 OMA a dal 6 19 X A AT 6 19 Z O O A IT 83 A nni 86 207 PillCam Capsule Endoscopy 208 Index
77. GlyEN IMAGING Expanding the scope of Gl Pillcam Capsule Endoscopy User Manual RAPID v8 0 DOC 2044 02 March 2013 COPYRIGHT Copyright 2001 2013 Given Imaging Ltd TRADEMARKS Copyright 2001 2013 Given Imaging Ltd GIVEN GIVEN amp Design PILLCAM PILLCAM amp Logo PILLCAM EXPRESS AGILE RAPID RAPID ACCESS ICCE ICCE Logos International Conference on Capsule Endoscopy BRAVO BRAVO PH SYSTEM VUESPAN VERSAFLEX GEROFLEX REPHLUX TRACER GASTROTRAC BILITEC DIGITRAPPER PHERSAFLEX MANOSCAN MANOSHIELD MANOVIEW ACCUTRAC ACCUVIEW and POLYGRAF ID are Trademarks and or Registered Trademarks of Given Imaging Ltd its subsidiaries and or affiliates in the United States and or other countries All other company or product names are the trademarks or registered trademarks of their respective holders All rights not expressly granted are reserved This device complies with Part 15 of the FCC rules Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation JPS Note Changes or modifications not expressly approved by Given Imaging Limited could void authority to operate the PillCam Capsule Endoscopy System Rx Only Given Imaging 3950 Shackleford Road Suite 500 Duluth GA 30096 USA supportUS givenimaging com ec REP Given Imaging GmbH Borsteler Ch
78. LG Note DO NOT remove the USB storage device until after any actions performed with it are completed e Rename Rename the selected archive e Move Up Move the selected archive up on the archive list display e Move Down Move the selected archive down on the archive list display Loading a Study with the Study Manager 7 PillCam Capsule Endoscopy 78 Studies The study lines displayed are links to the studies located in the selected archive Each line represents a link to the study Study Columns By default the studies are sorted by the last modified study the Video Created column The column that is sorting 1s represented by an arrow In the example below the studies are sorted by Video Created the date that the video was created Last First Capsule Procedure Refering Ordering as fideo ware ii 7 a a Name Name ID Gender Type Date Physician Physician ICD Code Created Findings Reports COLON 27 May 09 Dr Korens 55 897 Male dor Female ESO 6me07 Ew TU o LE Montager De Jerek 5 7 p we fo e fooro fiano ewe o e ma u oon feren 7 mu i aw PON 7 aco ian The studies are identified by several parameters that define the study such as patient name capsule procedure type and referring physician Additionally a check mark in the following columns indicates the availability of the following e Video Created Study includes a video of the procedure e Findings Study include
79. N Sensor Location Guide For Small Bowel Capsule Endoscopy Intersection of right 7 intercostal space and right mid clavicular line Xiphoid process IMAGING Intersection of left 7 intercostal space and left mid clavicular line Right lumbar region at umbilical level Above Umbilicus Navel Left lumbar region at umbilical level Right mid inguinal region Left mid inguinal region English P N DOC 0340 01 Standard Sensor Location Guide Pediatric Sensor Location Guide 36 Fitting Equipment on the Patient Sensor Label Sensor Color A Black B Yellow C Brown D Blue E Purple F White G Green H Red Preparing for PillCam Capsule Endoscopy Sensor Location Intersection of right 7 intercostal space and right mid clavicular line Xiphoid process Intersection of left 7 intercostal space and left mid clavicular line Right lumbar region at umbilical level Above umbilicus navel Left lumbar region at umbilical level Right mid inguinal region Left mid inguinal region COLON 2 Sensor Locations GIyEN Pillcam a Sensor Location Guide for PillCam COLON 2 Intersection of right 7 intercostal space and right mid clavicular line Mid upper region of right gluteus Intersection of left 7 intercostal space and left mid clavicular line Right lumbar region at umbilical level Suprapubic region Left lumbar region at umbilical level Right mid inguinal region Lef
80. PillCam Capsule Endoscopy Template Selection for Report The template drop down list shows 4 templates that can be selected before generating a report The 4 templates to be shown in the drop down list can be configured from a pre loaded library of 12 report templates of different variations The templates differ from each other in the inclusion or exclusion of the Localization track the SB Progress Indicator associated with each thumbnail and the size of thumbnails displayed in the final report It is at the discretion of the user to configure which templates to use in the workflow Only 4 of the 12 reports will be shown in the drop down list in the Report ribbon The selected report template will be used for each particular case To configure the templates see Report Templates Section on page 142 z a Template Medium pics a select All Thumbnails 13 D R po IS Spite NI i lo Unselect All Thumbnails 4 u p appear on Med Preview Print Save Save Sendas Export Report ribbon MES Select Current Thumbnail As Attachment 3 AE Configure E Report g Pia Cd pics ALG Note Upgrading the RAPID software from v7 to v8 will replace all templates and their configuration Other Commands in the Configure Buttons Group Button Function i Select all thumbnails for inclusion in the capsule SL Select All Thumbnails endoscopy report or when saving clips and images Unselect all thumbnails to exclude them from the capsule endos
81. Report screen in the Configure ribbon group e inthe Report screen in the Image Data ribbon group Overview of the RAPID Interface 89 PillCam Capsule Endoscopy 90 Quick Access Toolbar The Quick Access Toolbar is the small area to the upper left of the ribbon that contains a set of frequently used commands By default the following common commands are displayed in the Quick Access Toolbar Button Action Button Action os Closes the current study and 5 Browses to open a new returns to the Home screen video E Opens the Study Manager F Saves the Findings Opens the Atlas Goes to the previous y image Goes to the next image a To remove the command shortcut from the toolbar right click the command and select Remove From Quick Access Toolbar E ge ip RAPD DilifamSR Physician Me Sehnaider _ CRT ID 194 1 E I view Remove from Quick Access Toolbar NN ile Show Quick Access Toolbar below the Ribbon r e manipis oe Ribbon On SBI COV y A Mode Dual Quad Mosaic g Q A 2 fs Adjust Image Adjustment Preview Viewing Layouts When right clicking the Quick Access Toolbar there are two other options to select from e Show Quick Access Toolbar below the Ribbon Moves the toolbar below the ribbon To return the toolbar above the ribbon right click the toolbar again and select Show Quick Access Toolbar above the Ribbon e Minimize the Ribbon Hides the ribbon temp
82. Settings gt Report tab Select templates for Template name that will Report layout appear on Report ribbon Select Report template file name Template Name o Localization Progress Indicator Large pics Extra large pics combination Image M Localization Progress Indicator Image M Localization Progress Indicator Image AL Localization Progress Indicator Image XL Localization Progress Indicator aren Image XL Localization Progress Indicator aia s Image XL Localization Progress Indicator rt data Every template file name contains a variation of the features that determine the layout of the patient report The abbreviations of features in the filename are explained below e Localization include localization of the GI tract with an indication of the progress of the capsule during the time that the thumbnail was taken This 1s available only for SB and COLON procedures performed with sensor array e Progress Indicator displays both the capsule progress and the time elapsed in the Small Bowel in percent format e Image L displays large thumbnails on the report printout Note that this will use up additional paper when printing the report e Image XL displays extra large thumbnails on the report printout Note that this will use up additional paper when printing the report The templates are defined by either an inclusion or exclusion of the features descr
83. The right side graph represents an estimate of the redundancy or similarity of the images captured by the capsule as it moves through the small bowel and may indicate where the capsule moved slowly through the bowel Level of image similarity Reviewing progress indicator Using RAPID to View a Video 111 PillCam Capsule Endoscopy 112 You can move the video display to a certain location by clicking that location on the Progress Indicator Hovering the mouse anywhere on the Progress Indicator loads an image from that location in a pop up window The top of the window shows the progress of the SB reviewed in percentage Colon Location Diagram The Colon Location Diagram a three sided localization diagram represents the three colon sections ascending or right colon on the left side transverse colon on the upper side and descending or left colon on the right side This feature is available for PillCam COLON videos of procedures performed with a sensor array as well as a sensor belt in addition to the localization track It displays the colon segment containing the displayed image 1s by highlighting the corresponding section in the diagram The Colon Location Diagram becomes active after you landmark the first cecal image Once you have landmarked the Hepatic and Splenic Flexures either independently by identifying these landmarks or by accepting the suggested landmarks of the RAPID if the procedure was performed
84. a Copy displays error message that Video Copy was unsuccessful into cradle properly wipes e Firmly insert the recorder into the cradle Cause Action Wrong recorder bar is Select correct recorder bar selected 1 Check USB and power connection to the cradle 2 Contact Customer Support Computer does not recognize PillCam recorder DR2 Wrong recorder bar is Select PillCam recorder DR2 selected Recorder bar Send error message to Customer displayed Support Not enough space Delete PRRs from hard drive message is displayed Workstation freezes Contact Customer Support during video creation Return capsule to blister Activate second capsule If problem persists contact Customer Support Send malfunctioned capsules to Given Imaging Ltd Wait until 8 hours have passed and take off the sensors 2 Send video on CD DV Capsule failure PillCam recorder DR2 failure Capsule failure PillCam recorder DR2 failure Contact Customer Support Capsule failure PillCam recorder DR2 failure Turn PillCam recorder DR2 off Take out the battery pack and place it back in 3 Turn PillCam recorder DR2 on 4 If problem persists contact Customer Support Battery exhausted Replace battery and continue procedure Cancelling the Data Copy in mid sequence triggers PillCam recorder DR2 malfunction Video Copy message PillCam Recorder DR2 Error Messages Message Full name not defined for this user Please
85. able in the Regimen Manager before performing patient check in see Post ngestion Patient Instructions on page 151 Make sure the PillCam recorder is fully charged and connected to RAPID Performing Patient Check in Preparing for PillCam Capsule Endoscopy 2 From the Home screen click Pa Patient Check in RAPID sica Patient Check in Recorder Download E View Study a nica Gee GlyEN IMAGING 3 Inthe Procedures screen click the Recorder bar re E o Recorder bar 4 Click Check in Patient Caution When placed in the cradle RAPID 8 will perform updates to your existing PillCam recorders It is important to follow the instructions displayed on the screen Do not stop the update process until it is finished e For the PillCam recorder DR3 RAPID will perform a mandatory update e For the PillCam recorder DR2 follow the instructions detailed in the Note below o Performing Patient Check in 25 PillCam Capsule Endoscopy ALG Note PillCam recorder DR2 only If the PillCam recorder needs a software update this message appears This PillCam recorder needs an update Do you want to update your PillCam recorder right now We highly recommend you perform this upgrade unless you are an ESO2 user Upgrading the DR2 to SB3 support will deactivate ESO2 support If you are working with several recorders designate which will support ESO2 procedures and which will support SB3 pr
86. ain the procedure report images and video clips if any and an XML file containing the report data including the path to these files pS Patient Summary This option enables hospital administrators to later import i s the files with related attachments from this predefined directory To enable this data sharing the structure of the input and output of the files must be defined for the RAPID software Consult the RAPID v8 IT Guide for more information e Export a Patient Summary that contains the report thumbnails and video clips that can be played in Windows Media Player This option enables the patient to keep the procedure data archived or to use as the summary for a physician referral Creating a PillCam Capsule Endoscopy Report 119 PillCam Capsule Endoscopy Button Function For both export options above the data can be exported to a drive directory which is pre defined in Settings or to a CD Simply check the box Export to directory and type the location to where to export This can be done for both the Results Export and Patient Summary Export Results Export Y Include video clips in export data Y Export to directory Cer ES Patient Summary Export Y Include video clips in export data Y Export to directory CA em If the Export to Directory is left unchecked a screen prompting to select a location to export will be displayed each time you export When exporting the results or patient
87. ars displaying all the regimens or patient instruction templates available c Select your item and click Print ALG Note RAPID will print the regimen only if the regimen you selected is approved by a physician This Regimen Is Approved appears next to the Approve Regimen button at the bottom Print Layout of the Post Capsule Ingestion Instructions The Regimen Manager enables two convenient print layout options for the post capsule ingestion instructions The desired default layout can be configured in the RAPID settings by clicking the Report tab and selecting either pocket format or page format Regimen format _ Print in pocket format e Print in page format 154 Regimen Manager Print in Pocket Format Configuring RAPID Software When enabled the post capsule ingestion instructions will be printed in a convenient pocket format with fold lines for folding to an easy to carry size quarter fold The pocket format will show the Instructions guide on one side and important contact information on the other Fold lines SE AA Tee A BEd ia ea Aa ey DUALIGAA ee E E a ia fa a ra ica ed S00 pn PAA bebe A a F Ya Sees a gag ee E i j ee A HA A Soe A AN AA ee oe A as a ia ee E E peed 0100 ee PP E A A A A A yl E 4 r i o CENTER LOCA CAT EL 200 OPTRA T Sei pps a a i a May Hr ot PG A DO ie nte Pa Pa o A OR creer ENTER AA E ie UU PEA AA A ey A E ES a botar a a da a do a a Bek da da A
88. ary files PDF Reports generic XML format Capsule Endoscopy report data Displayed data Single and multi images Timebar Colorbar with region specific color and other diagnostic data Event marker Annotated thumbnails Viewing rate 5 80 fps Viewing Modes Single Dual Quad Mosaic and Collage view Dual head view ESO and COLON Run Modes View Automatic QuickView SBI Guidance and Manufacturer s Declarations PillGam Capsules No PillCam COLON 2 Guidance and manufacturer s declaration electronic emissions The PillCam capsules are intended for use in the electromagnetic environment specified below The customer or the user of the PillCam capsules capsule should assure that it is used in such an environment The PillCam capsules use RF energy only for its RF emissions Group 1 internal function Therefore its RF emissions are CISPR 11 very low and are not likely to cause any interference in nearby electronic equipment RF emissions The PillCam capsules are suitable for use in all establishments including domestic IEC 61000 3 2 establishments and those directly connected to Voltage fluctuations the public low voltage power supply network that exeremisci ne Not applicable supplies buildings used for domestic purposes IEC 61000 3 3 190 Guidance and Manufacturer s Declarations Technical Description Guidance and manufacturer s declaration electronic emissions The PillCam capsules are intended for use in
89. at see Print Layout of the Post Capsule Ingestion Instructions on page 154 144 RAPID Settings Configuring RAPID Software Check In Tab From the Home screen select Tools gt Settings Then select the Check in tab After making the changes to the settings click Apply to accept the new settings or click Cancel to close the Settings screen without accepting any changes Clicking OK will accept the new settings and close the Settings screen Settings HIS Information Directory OA y Brow System Wide Fox cance Cappy Configure Check in Fields Section To add frequently used Check in fields such as physician name and ICD Code 1 Select a Check in field from the list at the top of the screen and enter the corresponding values for this field 2 Click Add In the window below the text box you can see all the values already entered for this check in field 3 Use the Move Up and Move Down buttons to organize the defined values HIS Information Directory Section If a HIS system is available type the desired location from which to import patient data for Check in or click Browse to navigate to the desired folder RAPID Settings 145 PillCam Capsule Endoscopy 146 Other Tab From the Home screen select Tools gt Settings Then select the Other tab After making the changes to the settings click Apply to accept the new settings or click Cancel to close the Settings screen without accepting
90. aussee 47 D 22453 Hamburg Germany supportEU givenimaging com Table of Contents Chapter 1 USMO TINS GUC siria 1 CONVENTIONS ius 1 Chapter 2 Indications Contraindications Warnings Cautions cccceeeeeeeeeeeeees 3 INAICANONS TOr USE in AEE AA 3 COMMUNIC AUIOINS ns 4 PROVOEES CE EVENES crs hose sas eaten bs essa sI N 5 MY APTN OS na IS 9 65 1 11 6 9 eee o 7 Benefits and Risks PillCam Capsule ENdOSCOPY ccoccocccocccccconcccccnaconncnanonanoncnannnanonncnanenannns 8 AGCUTACY of th Device SB cin da didas 9 Acc racy ofthe DOvICO ES Vaio 10 Accuracy of the Device COLO Nina da 11 Chapter 3 Welcome to PillCam Capsule Endoscopy ccoccoccoccccccncconcnncononacancnarnarononanon 13 What is PillCam Capsule Endoscopy cncccccocccccconccocccoccnncnnccnncnncnnncnnnonnrnnnrnnrnanennrnnnrnnrnnnenanos 13 The PillCam Capsule Endoscopy ProcesSS occoccocccoccoccconconconnnonncnnconncnnrnancnnrnnnrnnnnnnrnnrnnnnnnos 13 PillCam Capsule Endoscopy System Components cccsccseceeeeeeeeeeeeeeeneeneeeneeeesenenenes 13 PUG Al GAD SUICSs pi abate 13 Handling the PillCam Capsule oocccoccocnccoccccnocononononanononocanonononanonanonononanonanonanonaninanenas 15 A A a 15 PIIGA SENSO aora a abs 15 RAPIDO PING A SAI e ao 16 Chapter 4 Preparing for PillCam Capsule ENdOSCOPY cncoccocccconconconcononccnronconcancnnennos 19 Preparing Ne Paleo aia da 19 Preparing the Required EquipMenNt ooococccccccccocconcnoconconco
91. burst 1 kV for input output IEC 61000 4 4 lines 1 kV line to line IEC 61000 4 5 2 kV line to earth 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Guidance and Manufacturer s Declarations Technical Description Guidance and manufacturer s declaration AA OA immunity for all equipment and AA OA lt 5 Ur Mains power quality should 295 dip in Ur be that of a typical Voltage dips for 0 5 cycle commercial or hospital short 40 Ur environment If the user of interruptions 60 dip in Uy the PillCam recorder DR3 and voltage for 5 cycles requires continued variations on operation during power power supply 10 Ur mains interruptions it is input lines 30 dip in Ur recommended that the for 25 cycles PillCam recorder DR3 be IEC 61000 4 11 lt 5 Uy powered from an gt 95 dip in Uy uninterruptible power for 5 sec supply or a battery Power Power frequency magnetic frequency 50 fields should be at levels 60 Hz characteristic of a typical 3 A m magnetic field location in a typical commercial or hospital IEC 61000 4 8 environment NOTE Uy is the AC mains voltage prior to application of the test le
92. c 30 recharge cycles DR3 ooocccnooccnnncnoconnnonononoss 44 Recorder Datura 21 68 o A A A 38 Recorder Download ooccocccnccnnccnnccnnccns 16 68 recorder poca 38 recorders update automatic ooccoccnocnonnncn 25 Regimen Manager sun 17 Regimen reminder cccocooccnnnnnnccnnnnnanonos 44 45 regimen patient check in cccccceeeeeeeeees 28 report template select ooooccnnnnonncnm m m gt ooo 118 LEPOT Choate ni 116 A A 5 e E 89 ribbon groups ccooooccnnnnnoccnnncnoconnnnnrononananonoss 89 PIBDON ADS aiae set 89 S SB Sensor Locations idas 36 SBE VIEN uno 102 SDcard id 44 search Study Manager ccccccsseecceeeeeeees 79 Sensor array troubleshooting cccooooccnnnonoccnnnnnnnonnss 170 SENSO id 15 A r o E eee 15 troubleshooting cccooooccnnnnnononnncnoronoss 171 Sensor Location Guide oooocccnnnnncccnnnnnocnnnnnos 34 S eae 17 Sale VIEW ali is 95 Si da 34 Spell CHECK esca turis 106 StAtUs A 78 STENOSES id 5 SCTE ici 4 5 studies siii 75 78 Study Manag er ooreen 75 Study Manager access cecccsssceeeeeeeeeeees 75 Study loadin t areeiro re ae E E 75 Slady OPU NS sas 78 Given Imaging PillCam Capsule Endoscopy Suggest SB Landmarks ooooccnnnnnoccnnnnnconos 110 suggest the Colon Flexure landmarks 110 swallowing disorders c ccsseecceeeeeceeeeeeeceees 4 T thumbnail comments occcoccnnccnocnnccnononocono 105 Thumbnail
93. c environment specified below The customer or the user of the PillCam capsules should assure that it is used in such an environment Portable and mobile RF communications equipment should be used no closer to any part of a PillCam capsule including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF VAMO Not applicable Not applicable 150 kHz to 80 MHz Radiated RF S d 1 2 P 80 MHz to 800 MHz 80 MHz to 2 5 GHz d 2 3VP 800 MHz to 2 5 GHz NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NOTE 3 P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m NOTE 4 Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range NOTE 5 Interference may occur in the vicinity of equipment marked with the following symbol C a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predic
94. capsules are intended for use in the electromagnetic environment specified below The customer or the user of the PillCam COLON 2 capsules should assure that it is used in such an environment 194 Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 6 kV contact 6 kV contact 8 kV air 8 kV air 2 kV for power supply lines Not applicable 1 kV for input output lines 1 kV line s to line s Not applicable 2 kV line s to earth lt 5 Uy gt 95 dip in Uy for 0 5 cycle 40 Uy 60 dip in Uy for 5 cycles 70 Uy 30 dip in Uy for 25 cycles lt 5 Uy gt 95 dip in Uy for 5 sec Not applicable Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the equipment requires continued operation during power mains interruptions it is recommended that the equipment be powered from an uninterruptible power supp
95. cluding its collar This value is entered for the largest ulcer in the tertile Lewis Score A capsule endoscopy scoring index for small intestinal mucosal disease activity Aliment Pharmacol Ther 27 146 154 Long segment Equal to 11 50 of a tertile Short segment Less than or equal to 10 of a tertile Tertile One third of small bowel as calculated by the transit time of the PillCam capsule in the small bowel e st SB Tertile is the proximal third of the small bowel e 2nd SB Tertile is the middle third of the small bowel e 3rd SB Tertile is the distal third of the small bowel Whole segment Greater than 50 of a tertile Ulceration Mucosal break with white or yellow base surrounded by a red or pink collar Lewis Score 125 PillCam Capsule Endoscopy Generating a Report 1 Click on the checkbox on the top left of the thumbnail to include it in the report e To unselect the thumbnail click the checkbox again e Optionally use the Select Current Thumbnail amp button to select or unselect the thumbnail e To select all the images click Select All r button e To unselect all images click De select All r button ALG Note Any disclosure of images taken by the PillCam Capsule Endoscopy System without the patient s consent might violate the patient s privacy rights To export findings without patient information click the De ldentify checkbox in the ribbon 2 Check De Identify to exclude any patient in
96. coooonccnnnnocnnnnnono 87 Delete Videos usais 17 Dialog Box Launchers csseeceeeeeeeeeees 89 diverticulardiscase dos 6 downlink loop revisa tica 34 downlink loop adjust oocccccoooccnnnnoccnnnnnnos 34 P wnload errada ibaits 67 DualiHead View a iaa 101 Dual MENS ii 95 DAD ll ad 69 83 A ee ee ee en 4 E clectromacnetio telde aci 6 Error Messages RAPD is 173 ESO Sensor Locations oocccccnocccnnnnncnnnnnnocnnss 35 ESOPLa CIS oe ee Rn 10 excretion of the capsule ooccoccoccnocconnncnnos 5 expiration date capsule cccccceeecceeeeeeees 38 F A nr pe nee an en tee 96 97 PUAN 8S lila 115 HANGINGS ODEN in 115 Hadings 4 SAV eC ca R 115 O a RE 4 5 G gastrointestinal obstruction occooccoocnonnncnncnnos 4 GIDICHOMEIY da 105 205 PillCam Capsule Endoscopy H A A 18 Hepatitis 18 A A ews 2 Home SC le CN se ica 16 HOW ca 18 Identity recorder aia 21 Image Adjustment oooccnnncnoccnnnnnocnnnnnnooo 96 97 image data TEStOle aaa id 15 Image data transmission occoccconnoccncnnonnncnnos 15 image dale TECOS ia iia 15 A O A 6 Indications for Usuarias sk 3 TAZA O il 43 intestinal adhesions cccooooccnnnnnoccnnnnnorononnno oo 8 L landmark create scccsecseccescoecceccesees 109 CandmarkS cias 103 109 TAN AUS old 22 ECD back ans 49 LEDs PillCam recorder DR3 cece eeee eee 50 LEWIS SC OLE di odas 123 Local ZAO aa 110 lOO TA 34 M mana
97. copy report or when saving clips and images Unselect All Thumbnails Select current thumbnail for inclusion in the capsule endoscopy report or when saving clips and images Anonymize patient information in the printed or exported capsule endoscopy report De Identify 118 Creating a PillCam Capsule Endoscopy Report Reviewing and Interpreting RAPID Videos Report Buttons Group Below is a description of the Report button group buttons and the commands that can be performed for managing the capsule endoscopy reports Button Function Preview the capsule endoscopy report before printing Clicking ke this button opens a print preview page of the report The paS buttons on top of the print preview screen also enable to print Bane Preview save save as or email the report as an attachment Select the printer number of copies page range and other Ma printing options before printing A version of the report is also E saved after printing Saves the report with a date and time stamp in the current Ri location with the current file name EN Save z Saves the report in the user selected location with the selected a name ca Sends a copy of the capsule endoscopy report in an email message as an attachment using your default email program The export button drops down to display the following export options e Export the Results of the capsule endoscopy to a folder in a predefined directory This folder can cont
98. corder DR2 ccccooccnnnnnnccnnnnnncnnnnnos 15 Troubleshooting ccocoooccnnnnnconnncnoronos 172 PillCam recorder DR2 charging 066 54 PillCam recorder DR2 software update 26 PillCam Recorder DR3 troubleshooting tai la 171 PillCam recorder DR3 ococoooncnnnnniccnnnnnoconnnnn 15 PillCam recorder DR3 charging oommm o 46 PillCam recorder DR3 LEDs 00e 50 PillCam recorder DR3 pairing c e eee 58 PillCam recorder initiation eeeeeeeee 43 PillCam recorder positioning ccceeeee 40 PillCam recorder preparing cseeeceee ees 43 PillCam sensor array applying c 0006 33 PillCam sensor belt applying ooooo 32 Pill anr SOUS OTS aiii 15 Polyp size estimation ccccocooccnnnnnocnnncnononoss 108 Post ingestion Instructions cccccseeeceeeees D2 Pie onan WOMEN iia 6 Pre ingestion Instruction Handouts 22 Q UA VIEW eat idad 95 Index Quick Access Toolbar ooccconccnnncncnnccnnnioccnos 90 COMMER EW all lia 99 R RAPIDUATIAS vasos 121 RAPID for PillCam software ooooncnnncmmm o 16 PP ES 67 real time viewer activate oooccoccnccncccncnnocos 47 Real time viewing cccoooccnnnnnnccnnnnnonononanononoss 43 Real time viewing activate cccoooomommm mmos om 48 Real time viewing PillCam recorder DR3 63 Reason for Referral check in o cco
99. ct the physician for evaluation and possible abdominal X ray procedure Instruct the patient to contact the medical staff if one of the adhesive sleeves detaches from the patient s body 19 PillCam Capsule Endoscopy I For COLON procedures use the Regimen Manager to create and select pre and post ingestion instructions see Regimen Manager on page 148 print for the patient and explain 3 Obtain the patient s informed consent 4 Before the procedure remind the patient about how to prepare for the procedure Remind them about appropriate clothing e If using the sensor belt upper garment of thin natural fiber cloth that is long enough to reach at least to hip level and will not ride up above the belt e If using the sensor array loose fitting two piece opaque clothing Preparing the Required Equipment Before the patient arrives for the procedure verify that the following equipment and accessories are available RAPID installed configured and open after accepting the license agreement PillCam capsule ESO SB or COLON PillCam recorder PillCam recorder pouch with shoulder strap Printed instructions for the patient Prepared PillCam sensor belt or PillCam sensor array with sensors already inserted in sleeves Sensor Location Guide ESO SB SB Pediatric or COLON if you are using a sensor array Water and drinking cup Any medication prescribed for the patient during the procedure Connecting the PillCam Rec
100. cted Video Tab From the Home screen select Tools gt Settings Then select the Video tab After making the changes to the settings click Apply to accept the new settings or click Cancel to close the Settings screen without accepting any changes Clicking OK will accept the new settings and close the Settings screen z Settings l e Video Creation Creation method Create video directly from recorder j _ First copy raw data then create video Video directory l C Videos Browse Raw data directory CAdatatranster Browse Y Allow Manual mode for non SB3 with DR3 procedures increases file size Video Data Management Copy raw data Compile raw data _ Disable video data management Research Tools Y Enable FICE Viewing Y Enable Polyp Size Estimation Y Enable Collage Viewing System Wide OK Cancel Apply RAPID Settings 139 PillCam Capsule Endoscopy 140 Video Creation Section You can copy the video data from the PillCam recorder to the computer a USB storage device or a DVD without compilation into a video To determine video creation method 1 2 3 From the Home screen select Tools gt Settings Select the Video tab In Video Creation under Creation Method select either Create video directly from recorder or First copy raw data then create video AS Note Select First copy raw data then create video to quickly release the PillCa
101. delay of prompting by alerts may be achieved by appropriate programming of the PillCam recorder DR3 either through check in see Performing Patient Check in on page 24 or through direct programming before capsule pairing see Setting Delay First Instruction in PillCam Recorder on page 57 The Regimen Manager tool enables the creation and editing of post ingestion patient instructions for colon procedures Refer to the Regimen Manager section Regimen Manager on page 148 to familiarize yourself with this tool For pre capsule ingestion regimen refer to Pre ingestion Instruction Handouts on page 22 and for Post capsule ingestions regimen refer to Post ingestion Instructions for Colon Procedure on page 22 General Patient Guidelines During the Procedure Make sure that the patient has the printed post capsule ingestion instructions or patient instructions with your contact information included and instruct the patient as follows e For COLON procedures using a PillCam recorder DR3 Explain to the patient that the PillCam recorder DR3 will alert him to perform instructions from the post ingestion instructions handout by beeping and vibrating and displaying on its screen the number of the instruction to be performed at the alert time When the PillCam recorder beeps and vibrates he or she should do the following a Check the instruction number on the PillCam recorder LCD screen b Press the Acknowledge button on the upper right corner
102. der bar e PillCam recorder s last use such as Recording Creating video The Create Video and Check in patient buttons become available 4 Click Create Video If there is enough space on the PC s hard disk the new video is created If not you are prompted to free up space see Freeing Space on Your Computer on page 159 During video creation the following changes occur in the PillCam recorders window 68 PillCam Recorder Download Creating RAPID Videos e The Create Video button becomes the End Video Creation button The Recorder bar displays e status and progress bar e patient name ID e name of the video to be created e battery status e the text Do not remove PillCam recorder flashes below the battery status until all data is copied or compiled into a video The images that are being copied to the computer are displayed in the Compiling Images window above the function buttons Creating Video from USB Storage Device or DVD RAPID supports video creation from media a removable USB storage device or DVD This can be useful 1f you have copied raw data from the PillCam recorder To create a video from a media 1 Plug the USB storage device into one of the USB2 0 ports of the PC or insert the DVD into the DVD drive 2 From the Home screen click Recorder Download RAPID stein Patient Check in Recorder Download E View Study Ca Y A A The Procedures screen appears 3 Clic
103. dings Repons ee eet A fee eset tt ttt ee ee Studies Action buttons Status bar Archives The Archive section displays the current procedure study archives that are accessible in the RAPID software The Study Manager can connect to procedure study archives located on the local computer on an accessible network or a removable storage media such as a flash drive or a CD DVD The different archive icons are explained below E 1 videos 1 An archive on a fixed drive such as the computer s hard disk or a drive on the network The default archive is the one selected in Settings gt Video gt Video directory The archive is added and defined by the user using the Add button This is explained below in Adding an Archive on page 76 A portable drive containing procedure studies connected to the computer s USB Portable drives connected to the USB are automatically detected and cannot be user defined Procedure studies stored on a CD DVD in the computer s DVD bay CD DVD archives are automatically detected and cannot be user defined Adding an Archive The instructions below demonstrate how to add an archive containing procedure studies that can be accessed from the RAPID software Portable drives connected to the computer s USB and studies contained on a CD DVD are detected and added automatically The archives on the Study Manager can be renamed or deleted but this will not affect the source directory of the archive Loading a St
104. ds 175 Y Sem Labeling ssc il 175 Gap SUE ADC NIN uo coto coloco nase auscen suosteee 176 Essential Performance sida a a 176 A danas lone del pectaabim bane tsaqetalessearaeegaannantantetseuenecuaneue 176 PillCam Recorder DR2 and PillCam Recorder DR3 ccccecceccseeeeeeeeeeeeeeeeeeneeeaees 176 WaNINIS 2 a 176 CAU ont 178 System Specifications sssri A A AN 179 RICM SDE e a eo nl 179 PIlCAM SB 2 Capsulas AS cubmeenesedeaneedGovcet outa 180 PIlGAM SB S Capsule vakiicgiccise iia 181 PIICam ESO 2 Capsule esc nescwsbeechua hovuned a a lts 182 PICA ESOS CAD SUIS sic irnn da 183 PilGalm COONNG QDS US nio isa 184 PIIGam COLON Z Ca Uli A a 185 Sensor Atray PillCam Recorder DIZ ns anida aa a sa 186 Sensor Array PillCam Recorder DR3 oocccoccccccnocccccnoconononocononononanonanonanonanonanonanonanonanonos 186 Pilca Recorder DRZ J20 tao 187 Cradle PIlCam Recorde DRZ sdana ryansoto 187 PING AI Recorder DAS N 188 Given Imaging V PillCam Capsule Endoscopy PillCam Recorder DR3 SDHC Memory Card cccccccceccesecceeceeeceneeseeeeueeeeeeeeeeaeeens 189 Grade PillC ant Recorde DR Ss tasas 189 DOC POWE SUP as 189 RAPID for PUIG ai SO Wa Sidi daa 190 Guidance and Manufacturer s Declarations cccccccceseceeeceeeeeeseneeeeeeneceeeenseeesensenesones 190 PillCam Capsules No PillCam COLON 2 occcoccococcccccoccconoconoconocononanononononocanonanonanenanoss 190 PillGam COLON 2 Cap UlIES ura lic 193 PIICa
105. e Type of modulated signal Effective radiated power Proprietary firmware Up to 15 hours LCD OFF 500 g including battery pack 3 5 4 2 VDC 0 15 0 5 A Internal Li lon 3 8 V typical 8800 mAH 0 40 C 0 55 C Up to 85 790 520 mmHg 434 1 MHz 10 MHz 13 6 MHz ISM Linear Chirp Digital data 27 4 dBm System Specifications Technical Description PillGam Recorder DR3 SDHC Memory Card Properties Dimensions 24 mm x 32 mm x 2 mm Weight 2 0 gr Capacity gt 16 GB Ratin Class 6 40X or higher J 6 MB sec minimum data transfer rate Storage temp 40 C 85 C Built in write protect switch prevents accidental data Security gee Compatibilit SDHC host devices not compatible with standard SD p y enabled devices readers File format FAT 32 Cradle PillCam Recorder DR3 Properties Weight 250g Operating temp 0 45 C Color White amp Black Input Current Maximum 4 A Min 100 mA DC Power Supply Properties Weight 300 gr Input connector 3 pole AC inlet IEC320 C14C Input Voltage 90 246 VAC Output voltage 5VDC 5A Protections Short circuit Over load Over voltage Over temp System Specifications 189 PillCam Capsule Endoscopy RAPID for PillCam Software Software RAPID proprietary version 8 Languages English French German Italian Spanish Portuguese Dutch Swedish Finnish Danish Chinese Mandarin Korean Russian Greek Data export JPEG Images MPEG Video clips grml Given propriet
106. e user This provides for fast previewing and landmarking of a small bowel video The RAPID scans all images and scores them according to the possible level of significance Then according to the percentage level set by the user it displays a short video to provide an overview of the case prior to full review see QuickView on page 99 The QuickView feature is not intended to detect pathology in lieu of a physician and should not be used as a substitute for reviewing the entire video Complementary QuickView mode Sets the Complementary QuickView previewing mode to show the complementary part of the video that is everything that was not included in QuickView see Complementary QuickView on page 100 Only a review of both QuickView and Complementary QuickView is equivalent to a full video read The Complementary QuickView feature is not intended to detect pathology in lieu of a physician and should not be used as a substitute for reviewing the entire video Review of both QuickView and Complementary QuickView is required for full video review Overview of the RAPID Interface Reviewing and Interpreting RAPID Videos Review Group Buttons Button Function Standard Review mode This button sets the standard review mode for gt PillCam SB3 AFR PillCam COLONZ PillCam ESO2 and PillCam ESO3 procedure videos Display rate can be set by the user by moving the viewing speed slider A mode Review mode This button sets the review mode to
107. e Pairing DR3 only on page 58 and when selecting display modes The icon above the navigation button at the bottom of the display area indicates the functionality of the button The table below shows the navigation buttons and their actions Icon Action when pressed Icon Action when pressed 4i Confirm select Manually activate AFR mode in PillCam j AFR COLON 2 capsule and activate instruction 1 if gastric passage of the capsule is detected and the AFR mode was not entered automatically t Scroll up the cursor Activate Real Time viewing followed by pressing the right then left buttons within 6 seconds ya Switch video head in Real Time viewing mode Exit Real Time viewing Scroll down the cursor P Mark displayed frame m PillCam Recorder DR3 Know Your PillCam Recorder Button Pressing Indication An audio beep and visual indications on the PillCam recorder DR3 button pressing feedback is as follows e Ifthe LCD backlight is off then the Ist pressing on any button turning the PillCam recorder DR3 screen backlight on should not be accompanied with any audio feedback except turning the backlight on e Ifthe LCD backlight is on e Any momentary pressing on a button affecting a function such as volume control Real Time access combination scroll up down or left right and select buttons will yield an audio beep feedback immediately after pressing e Any continuous pressing on a button 1 e press for 3 sec
108. e drinking and ingestion 2 Instruct the patient not to talk during the procedure 3 To verify that the system is operating properly hold the capsule in front of the patient s abdomen very close to the sensors practically touching through the clothes one of the sensors Hold it for at least 15 seconds and check that the capsule LED on the PillCam recorder blinks at the same rate as the capsule 4 Have the patient swallow the capsule with a sip of water PillCam SB or PillCam COLON Capsule Endoscopy The PillCam recorder starts blinking when the capsule has been activated 1 The patient may be seated or standing 2 To verify that the system is operating properly hold the capsule in front of the patient s abdomen very close to the sensors practically touching through the clothes Hold it for at least 15 seconds and check that the capsule LED on the PillCam recorder blinks at the same rate as the capsule 3 Have the patient swallow the capsule with a sip of water Capsule Ingestion 61 PillCam Capsule Endoscopy After Capsule Ingestion PillCam ESO The patient must stay at the medical facility until the end of the procedure approximately 30 minutes after ingestion of the capsule Remove the PillCam recorder and sensors from the patient The patient may then be released and can return to a normal daily routine PillCam SB Once the patient has ingested a PillCam SB capsule the patient may leave the clinic Make sure
109. e sensors are placed on the body according to anatomical reference points the distances between sensors may vary from patient to patient If you are using a sensor array with a downlink loop adjust the downlink loop to remove excess cable so that it fits closely to the patient s body To prevent damage to the wires do not forcibly bend the downlink loop in any way When the patient gets dressed make sure that the sensor array connector remains outside of the patient s clothing and make sure that the patient is not uncomfortable with the equipment Fitting Equipment on the Patient Preparing for PillCam Capsule Endoscopy ESO Sensor Locations PillCam recorder DR3 PillCam recorder DR2 Sensor Label SensorColor Sensor Location A Black Upper Sternum on the bone B Yellow Xiphoid process C Brown Intersection of left 7t intercostal space and left mid clavicular line Fitting Equipment on the Patient 35 PillCam Capsule Endoscopy SB Sensor Locations For DR3 meen Location Guide for small Bowel Capsule Endoscopy a Intersection of right 7th intercostal space and right 7 mid clavicular line a Xiphoid process y Intersection of left 7th a intercostal space and left 7 midclavicular line Right lumbar region at retical level j E Above umbilicus navel Left lumbar region F at umbilical ba 6 Right mid inguinal ES region H Left mid inguinal region TEN wo For DR2 GIyE
110. e signals L i Blinking rate capsule frame rate A PillCam recorder has stopped capturing capsule signals for more than 5 t seconds Y 7 It PillCam recorder is detecting a capsule in sleep mode lt j 1 Blinking rate every five seconds in any color i E PillCam recorder is malfunctioning H PillCam recorder is synchronizing with a capsule This is normal functioning lt gt Y lt 20 seconds A PillCam recorder detects capsule signal but is not recording it This is a i 7 malfunction 20 eeConds Check the sensor array connection or have patient move to a different location maximum Battery charge level When charging the battery LEDs do not blink 25 When PillCam recorder is out of the cradle the battery LEDS blink once every 5 seconds I below 10 A PillCam Recorder DR2 55 PillCam Capsule Endoscopy Connecting a PillCam Recorder to a Personal Computer PC The PillCam recorder needs to be connected to a PC with RAPID in the following cases Connect for initialization For initialization before the procedure to check in a patient Connect for Downloading For download after the procedure to create a video or copy the video data Connect for Charging For charging the PillCam recorder after the procedure to prepare the recorder for the next procedure Connect for Upgrading When the software version of the PillCam recorder 1s lower than the latest one internally specified in the RAPID th
111. e user is prompted to allow a recorder upgrade the first time the recorder is connected to the RAPID for check in It is highly recommended to allow the upgrade The latest software versions for both PillCam recorder DR2 and PillCam recorder DR3 are stored in the RAPID and when prompted and allowed the appropriate upgrade will be performed ZO Note It is recommended to use an external hub when connecting multiple PillCam recorders The PillCam recorder is connected to the PC only through its cradle each model through its cradle The PillCam recorder is passive during these cases and no controls need be operated on it Connecting a PillCam Recorder to the External Real Time Viewer The PillCam recorder may be connected to an external real time viewer which is a dedicated tablet PC with real time viewing software and special setup for viewing in real time the images captured and stored in the recorder This functionality exists for both recorder types PillCam recorder DR2 and PillCam recorder DR3 the latter has also the built in capability to perform real time viewing through the recorder s display For a real time viewing session both recorder types connect to the external real time viewer tablet PC through a USB cable while the tablet PC or anything connected to it must not be connected directly or indirectly to any wall outlet The real time viewing software in the tablet PC controls the session and the PillCam recorder is passive
112. ear at the bottom of the screen Double click on the video image in the center of the screen to designate 1t as a thumbnail Alternatively click the Capture Thumbnail button located next to the video player buttons to add an image that appears on the screen to the thumbnails NS Note The thumbnails and associated comments are saved in the Findings file see Working with Findings on page 115 Each thumbnail appears in the Thumbnail section To create a thumbnail Double click the video display or click the Capture Thumbnail button To view a thumbnail in the video display Double click the thumbnail The RAPID automatically displays the desired image on the screen the cursor in the Time Bar jumps to the thumbnail location in the video The thumbnail in the thumbnail section will be highlighted with a blue filled outline Using RAPID to View a Video 103 PillCam Capsule Endoscopy 104 To view the adjacent images In the View screen use the and buttons to view the adjacent images or roll the mouse wheel forward or backward In the Report screen roll the mouse wheel forward or backward to view adjacent images of the video to capture these as new thumbnails In the Report screen use the and gt buttons to view the adjacent thumbnails To scroll through the thumbnails If there are more thumbnails than fit on the screen RAPID allows you to scroll through the thumbnails by several alternative modes An arrow a
113. eception antenna Transmission antenna of sensor elements Sensor size Color Material Antennas wire material Antenna structure Size Color Material 3 or 8 sensors Diameter 40 mm Black Polyurethane Teflon Coax wire Loop antenna 1 9m Black Polyurethane Teflon System Specifications PillCam Recorder DR2 2C Properties Physical software Recording capacity Weight Operational Power Battery type Battery Pack weight Operating temp Storage temp Storage and Operating humidity Storage and Operating pressure Technical Description Proprietary firmware PillCam recorder DR2 2fps for 10 hours PillCam recorder DR2C 4fps for 10 hours 500 gr including battery pack 6 10 VDC 100 250 mA Internal Li lon 7 2 V 4400 mAH 200 gr 0 40 C 0 55 C Up to 85 790 520 mmHg Cradle PillCam Recorder DR2 Properties Weight size without battery inserted Color Power mains range System Specifications 890 gr 14 D x 165 W x 97 H mm Black 100 to 240 V 187 PillCam Capsule Endoscopy 188 PillCam Recorder DR3 Properties Physical Receiver Rx Transmitter software Recording capacity Weight Operational Power Battery type Operating temp Storage temp Storage and Operating humidity Storage and Operating pressure Operating frequency Bandwidth of the receiving section in this band Operating frequency Frequency band Modulation typ
114. ecessary the equipment or system should be observed to verify normal operation in the configuration in which it will be used e PillCam video capsules and PillCam recorder may be interfered with by other equipment even if that other equipment complies with CISPR emission requirements 176 Essential Performance Warnings Technical Description Do not disassemble or modify the battery pack The battery pack is equipped with built in safety protection features Should these features be disabled the battery pack can leak acid overheat emit smoke burst and or ignite Do not use or leave the battery pack of the PillCam recorder near a heat source such as a fire or a heater 80 C or higher If the resin separator should be damaged owing to overheating internal short circuiting may occur to the battery pack possibly leading to acid leakage smoke emission bursting and or ignition of the battery pack Do not immerse the battery pack in water or seawater and do not allow it to get wet Otherwise the protective features in it can be damaged it can be charged with extremely high current and voltage abnormal chemical reactions may occur in it possibly leading to acid leakage smoke emission bursting and or ignition Do not recharge the battery pack near fire or in extremely hot weather Otherwise hot temperatures can trigger its built in protective features inhibiting recharging or can damage the built in protective features causing it
115. ed signal is received the PillCam recorder automatically shuts down e After starting receiving signals form a paired capsule if there is a gap of 30 minutes of no signal reception the PillCam recorder DR3 shuts down AK Note When the PillCam recorder DR3 is on its screen backlight goes into an off mode if the screen or recorder controls are idle for more than 3 minutes If the PillCam recorder DR3 is on but the screen is off press any key to turn the screen on Once the PillCam recorder DR3 screen is activated proceed with pressing the desired function button Regimen Reminder Regimen Reminder is a reminder function whereby the PillCam recorder alerts the patient to perform dietary instructions during a PillCam COLON 2 procedure The alerts are timely instruction numbers that appear on the recorder screen together with some audio and tactile alerts to draw the patient s attention to the alerted instruction number The patient is required to acknowledge the alert by pressing an acknowledge button on the recorder and execute the associated instruction detailed on a patient instruction sheet The PillCam recorder DR3 is programmed during the initialization to remind the user according to an uploaded regimen instruction set which is also printed out and handed to the patient The timing of the regimen instructions 1s synchronized to the moment of PillCam recorder DR3 pairing with the PillCam capsule The last instruction alerted is displayed
116. eee chalet a o e eta 62 Real Time Viewing with PillCam Recorder DR3 Only lInternal Mode 0 0008 63 Real Time Viewing with PillCam Recorder DR2 Only EXTON Al WO GG airada psa ads 64 Removing Equipment from the Patient ooncoccccnnoccconcncccnnconcconcncnnnnronnnnnnnnncnnrnanennrnanenanos 65 ji Table of Contents PillCam Capsule Endoscopy Chapter 7 Creating RAPID VIGCOS esa 67 PilGam Recorder DoOWRIO diria 67 Creating a Video from the PillCam Recorder oocooccoccnoocnoccnoconononocononanonanonanonanonanenos 68 Creating Video from USB Storage Device or DVD oooocccncccncccncnccnccoonconnonononnnnnanonaninanonos 69 Baten Video Crealo o e os ets 70 Pauseend Video Crealo usual O N 70 Managing RAPID Video D ta ui d 70 Copy Data froma PillCam Recorder autovia ita 71 Manada Data FIeSaiireen ecieaeved seems ieee R D E O 12 Bar As A 73 e e141 p16 IG CoM A May cee aner ee eat ean ned ty tee fee ene eR eee eee 13 Chapter 8 Reviewing and Interpreting RAPID Videos coccoccoccoccocccccccncnoncnncnnnnnnans 75 Loading a Study with the Study Managet cccccceeesseeeeeeeeeeseeseneseneeeeeseeeesnesensseneseeeees 75 PAE CIMINO Sesser sa a oes ween ark ees ae eects ens tse edandicuastec cant A 76 A O alwaae een danaaee eva AA 78 Understanding the Status Bates its 78 A EE 19 SEACA FUNGUO Nescia A eae ee ae tera 79 WAMAGING GC CIMA Si li ls 81 USING the Study Manage isso 83 OPM a ais 83
117. een see PillCam Recorder DR3 on page 171 for troubleshooting details 4 Ifusing a PillCam sensor array tuck the vibrating connector component between the recorder pouch and the patient s abdomen This will ensure that the tactile vibrating alerts will be felt by the patient Positioning PillCam Recorder DR2 1 If you are using the recorder pouch hang it from the patient s shoulder while the patient is standing If you are using the recorder belt secure 1t around the patient s waist while the patient 1s standing ALG Note The sensor array connector and wire should hang over the top of the recorder belt 2 Make sure the locking handle at the back of the PillCam recorder is open 40 Fitting Equipment on the Patient Preparing for PillCam Capsule Endoscopy 3 Slide the two protrusions on the connector into the matching grooves in the PillCam recorder Protrusions on connector Grooves in PillCam recorder Locking handle f is open before connecting sensor array 4 Verify that the connector is inserted completely and then lock it by closing the handle on the PillCam recorder Closed handle 5 Make sure that the PillCam recorder is on the battery LEDs light up once every 5 seconds AL Note e Remind the patient about wearing and handling the PillCam recorder with care see General Patient Guidelines During the Procedure on page 23 e Make sure the patient has the printed instructions see To P
118. en video that provides a preview of the changes you are making 7 Click Save to save your settings The next time you turn on the Image Adjustment these settings are applied 8 If you wish to return to the factory preset click Reset 9 Click Close to close the Image Adjustment screen Zoom Group This ribbon group contains the controls for displaying the video image at different zoom levels Button Function E Fits the image size to the window 132 Changes the zoom of the video view by sliding left or right and displays S the current zoom in percentage Show Group This ribbon group enables the display or hiding of video viewing features Using the check boxes next to the features you can enable or disable the following e Show Thumbnails Show Localization Show SB Progress bar SB videos only Show Comments Editor 98 Overview of the RAPID Interface Reviewing and Interpreting RAPID Videos Button Function Click to show all features in the Show group Clicking again will only show the features that were previously enabled Shows the video in full screen on the computer screen without any of the other elements of the View screen including the ribbons To return to normal view press ESC Pressing F11 on the keyboard has the same functionality Using RAPID to View a Video To view a video you can open a video from Study Manager by clicking View Study and then selecting Study Manager on the RAPID home sc
119. ensor is connected PillCam recorder is checked in PillCam recorder is waiting for check in Sensor failure AFR mode activated for PillCam SB3 and for PillCam COLON 2 capsule following gastric passage detection of the capsule by the PillCam recorder DR3 Regimen reminder numbers appear in status line when recorder is in Real Time Viewing mode Indication for the detection of end of procedure EOP It indicates that the procedure has ended and equipment may be removed It occurs when a predefined reception gap from the paired capsule is encountered The gap threshold for end of procedure detection is capsule type dependent 10 minutes for PillCam SB and PillCam ESO and between 10 minutes and 30 minutes for PillCam COLON 2 depending on the time in the procedure In particular this also indicates excretion of the capsule as a trigger for the EOP which is the most trivial reason The PillCam recorder DR3 shuts down automatically at least 5 minutes after the end of procedure indication 51 PillCam Capsule Endoscopy Check in Screen Icons After performing patient check in these icons appear on the PillCam recorder screen data area Icon mje Name Patient name Patient ID Error Messages Popup 62 63 50 70 52 Se Message No approved memory card is detected Verify approved card is in the PillCam recorder Memory card is write protected Memory card error Remove and reinsert card I
120. ent GI motility Final diagnosis based on the RAPID video should be made only by physicians who are trained in the interpretation of capsule endoscopy images The Lithium Ion battery pack in the PillCam recorder DR3 incorporates built in safety devices Do not use the PillCam recorder in a location where static electricity greater than the manufacturer s guarantee may be present Otherwise the safety devices can be damaged possibly leading to acid leakage overheating smoke emission bursting and or ignition PillCam Capsule Endoscopy Benefits and Risks PillCam Capsule Endoscopy Benefits PillCam capsule endoscopy is the most widely used patient friendly tool for visualization of the GI tract To date more than 1 700 000 patients worldwide have benefited from PillCam endoscopy After the patient swallows the PillCam video capsule images and data are transmitted wirelessly as the capsule passes through the digestive system The images are captured and stored in a PillCam recorder worn by the patient after the procedure is complete the images are reviewed by a physician PillCam capsule endoscopy offers a simple safe and non invasive alternative to traditional imaging procedures The procedure does not require sedation intubation bowel insufflation or radiation Patients may continue with their normal daily activity during the procedure The PillCam patency capsule provides a simple and convenient means to verify functional
121. entire video by a qualified physician e Using the mouse scroll wheel in this mode also displays each frame of this mode one by one e Inthe QuickView mode the video navigation buttons change to the following e The user can determine the number of images of the RAPID video to be viewed in the QuickView mode by changing the percentage rate of images to be shown and hence the sampling rate which is by default 10 To change the QuickView sampling rate 1 From the View screen click the dialog box launcher of the Preview ribbon group The following screen appears Preview QuickView Settings 10 ES S Restore Default OK cancer 2 Type in the desired sampling rate between 2 and 80 for the QuickView and click OK to save it ZG Note When viewing a video in CQV mode you cannot change the QuickView sampling rate Complementary QuickView After viewing the video in QuickView mode click the CQV Complementary Quick View button to view rest of the video not shown in QuickView mode In Complementary QuickView mode CQV RAPID displays only the images that are not included in the QuickView mode Playing a video from start to end in QV mode and then in CQV mode results in viewing all video images Using RAPID to View a Video Reviewing and Interpreting RAPID Videos Viewing a Video If not using QuickView and Complementary QuickView combination to view a RAPID video you can use the View button t
122. eo creation is complete and so you may disconnect the PillCam recorder OS Note e Inthe rare case that the video creation fails RAPID prompts you to save the raw data for customer support e You can reduce the file size while copying data see Video Data Management Section on page 140 e When downloading from four recorders simultaneously ensure that there is at least to 40 gigabytes of hard disk space e Make sure that the computer power settings are not set to sleep or to hibernate modes Caution Connection of the PillCam recorder to the RAPID software for patient check in video download and recorder upgrade must be done using the appropriate cradle o _ 67 PillCam Capsule Endoscopy Creating a Video from the PillCam Recorder To create a video from the PillCam recorder 1 Place the PillCam recorder in the cradle Make sure that the cradle is connected to the computer on which RAPID is installed and open 2 From the Home screen click E Recorder Download RAPID sica Patient Check in L Recorder Download Eve Study a aD a GlyEN IMAGING The Procedures screen appears with the Recorders tab on top ee 3 Click the Recorder bar that corresponds to the PillCam recorder with the desired data e When the correct Recorder bar is activated and you click on the Identify button the corresponding PillCam recorder LEDs blink e The relevant patient information is displayed on the Recor
123. eople authorized to use RAPID e The names of medical personnel involved in PillCam procedures so these appear on the report e Preferences and customization of CE capsule endoscopy reports e and more These settings affect all PillCam procedures performed with your RAPID For example the medical personnel names you enter during configuration are available for selection at patient check in performed on your PC or workstation If you set units of measurement to centimeters and kilograms all patient data is shown that way To reach the Settings screen select Tools gt Settings from the Home screen RAPID sica Patient Check in Y Recorder Download E View Study Regimen Manager Settings Atlas Delete Videos User Dictionary System Wide Settings gt GIyEN IMAGING The RAPID software settings are divided by tabs that categorize the settings options into the following divisions e General eo Video e Report e Check In e Other Each tab is also sub divided into separate sections In the explanations on settings below some of the information may also be available in the corresponding chapter of the feature For instance the Regimen format section describes in brief the two options for printing a regimen however the Regimen manager section displays the printout examples for comparison RAPID Settings Configuring RAPID Software General Tab From the Home screen select Tools gt Settings
124. eparing for PillCam Capsule Endoscopy e Continue fasting until capsule leaves the stomach If capsule is delayed in stomach ingest a customized prokinetic agent e Intake the first boost laxative and water when necessary directly after capsule leaves the stomach e Intake second boost laxative dose and water when necessary 2 4 hours after the capsule leaves the stomach e Eat a light meal depending on capsule progress 3 hours after second laxative e Take a suppository 1 2 hours after the meal if required The execution of these instructions in a regimen is triggered by appropriate alerts from the PillCam recorder which senses the fulfillment of the conditions for the respective instructions and cues the patient during the procedure to refer to the associated instruction and execute it The difference between the regimens 1s in the use of specific laxative and prokinetic materials as well as some timing differences associated with these different materials It may happen that the execution of the instructions some of which drive the capsule through the gastrointestinal track needs to be delayed until the patient reaches suitable environment for the intake of the associated laxatives Such a case is when the ingestion is at the physician s office but the rest of the procedure may take place at the patient s home Under such circumstances it is desirable to delay the capsule driving instructions until the patient reaches home This
125. er archive such as a USB storage device e Saving a study or a file to a specific location e Saving a study as a Zip file e Burning a study or a file toa CD DVD For burning a single study to a disc no multisession see Saving a Study to a CD DVD on page 83 For burning files from more than one study use the CD burning program on your computer Given Workstations have either Roxio Drag to Disc 9 or DirectCD 5 Roxio Drag to Disc 9 Burning Procedure 1 Insert a blank disc into the disc drive 2 If you do not know where the files you wish to burn are located open the Study Manager by clicking E at the top of the screen or select View Study gt Study Manager from the Home screen 3 Move your mouse over the archive where the files reside and a tooltip appears with the location of the archive on the computer 4 Minimize RAPID by clicking in the top right corner of the screen 5 Click the Drag to Disc icon on the desktop The Drag to Disc screen appears Additional Settings 10 11 Configuring RAPID Software Drag to Disc E X Click El on the Drag to Disc screen and select Format Disc from the pop up menu The Format Options screen appears Type in the name of your disc in the box next to Enter volume name and click OK The Disc Preparation screen appears As soon as the Disc Preparation screen disappears double click My Computer on the desktop and browse for the location of the files you wish to copy to t
126. er at least the evening before ingestion as well as the morning of ingestion All these instructions including the customized laxatives are embedded in the pre ingestion regimen instructions Pre ingestion instructions for the respective PillCam procedures are printed and given to the patient before the day of the procedure Post ingestion Instructions for Colon Procedure In general the post ingestion instructions should result in the preservation of proper cleanliness of the colon during the colon procedure and also facilitate the timely progress of the PillCam COLON capsule in the colon to visualize the entire colon before capsule burn out or excretion This is achieved by instructing the patient in real time during the procedure to conditionally follow a set of instructions involving timely ingestion of prokinetics and laxatives The post ingestion instructions are grouped in a regimen that is selected by the physician from a library of possible regimens and are loaded into the PillCam recorder DR3 during patient check in see Performing Patient Check in on page 24 and they are also printed out in a handout to the patient During the COLON procedure the PillCam recorder DR3 alerts the user to perform the instructions detailed in the corresponding post ingestion instructions handout The post ingestion instructions 1 e a regimen consists in general of the following conditional instructions Creating Patient Instructions for the Procedure Pr
127. er in observing tissue surface characteristics and vascularity and by visually enhancing suspected structures All FICE settings are available when viewing SB videos and only FICE1 is available when reviewing a COLON 2 video Blue Mode provides another view of the mucosa that may assist in the interpretation process by rendering a bluish image to enhance contrast Clicking this button applies the factory presets for image adjustment Sharpness 3 Brightness 0 Color 0 Clicking this button AFTER you have made your own adjustments using the sliders preserves your setting for the next time you click Un To adjust the video image appearance 1 Click in the ribbon to turn on Image Adjustment to the factory presets or if you saved your preferences earlier to your own presets If you wish to adjust the image otherwise click 3 in the ribbon The following screen appears Select any of the active buttons FICE 1 FICE 2 FICE 3 or Blue for these preset image adjusters To adjust the image yourself click Configure On Button The screen expands Overview of the RAPID Interface 97 PillCam Capsule Endoscopy iess 0 r i a Reset Save 5 The On state means that image adjustment is applied to the image The expanded screen shows the settings currently in effect 6 Use the Sharpness Brightness and Color sliders to get the desired result as shown by the video image of the op
128. etric cm Kg k Full name format First Middle Last kd Thumbnail Editor Clicking the edit button in the top right corner of a thumbnail loads the Thumbnail Editor 106 Using RAPID to View a Video Reviewing and Interpreting RAPID Videos Buttons on the left of the thumbnail editor are tools to affect markings on the thumbnail see Markings Buttons Group on page 120 that also appear in the ribbon of the Report screen At the bottom you can type your comments into the Comments box Alternatively use the comments editor to type your comments for the thumbnail The Thumbnail Comments box is also located on the left side of the screen in the View screen if checked in the Show ribbon group It is displayed automatically in the Report screen If a thumbnail is selected to be included in the patient report any comments entered for the thumbnail will appear below it in the report Marking Tools You can add marks to a thumbnail to point out or emphasize certain areas of interest AL Note Marks on a thumbnail are saved together with the thumbnail and appear as such in the report and on the thumbnail itself To access marking tools eo View screen click in the top right corner of a thumbnail The thumbnail appears enlarged with all the marking tools at its left side e Report screen all the marking tools are in the Markings ribbon group Mark Circle Creates a circle around an area of interest su 1 Click
129. formation from the report 3 Select the desired template from the list in the ribbon 4 Ifyou have selected to request electronic signature feature option see Electronic Signature on page 143 enter the Windows login password A report like the one displayed below is generated and can be saved printed or sent as an email attachment The report template Image M Localization Progress Indicator 1s used to generate the below layout 126 Generating a Report Reviewing and Interpreting RAPID Videos Sample report Phvsici Capsule type ysician l Capsule Endoscopy Report PillCam SB name clinic a ls ss i Patient and Bere procedure information Reason for Referral Long term diarrhea and abdominal pain Passage times Patent tis passage tima 20m 155 Gastric passage tima 0h 12m Small bowel passage time 3h 35m Colon passage time 1h 54m Procedure Information and Findings Active bleeding and Infammation Summary and Recommendations inflammatory Bowel Disease Irregular Irritable Bowel Syndrome Signature 00 14 51 OF Jar G Thumbnail Capsule Progress 58 Time Thumbnail comment First Gastrit brag Localization Capai a Capsule E SB prog ress Sere Soin indication SE Tima SB Time Page 1 of 4 Image Data Buttons Group The Image Data ribbon group contains advanced tools for working with images video clips and segments Short RAPID video segments can be created and combined from different points in the
130. fy these lists click the Edit button Make necessary edits and then click Save and Close Regimen Manager Configuring RAPID Software 8 Ifyou wish to include your instructions for a fiber diet check the Low Fiber Diet check box This will display the list of Allowed and Not Allowed food or drink items To modify these lists click the Edit button Make necessary edits and then click Save and Close AS Note The Liquid Diet and Fiber Diet instructions are shared across all pre capsule ingestion regimens Any changes to the instructions will apply to all the pre capsule ingestion regimens 9 If you want to print this regimen later after saving it click Approve Regimen 10 When you are finished click Save This adds the regimen you created to the library of regimens available Post Ingestion Patient Instructions In order to ensure a successful procedure after capsule ingestion the patient must carefully adhere to the personalized Post Capsule Ingestion Instructions The post capsule ingestion regimen instruction uploaded to the PillCam recorder DR3 during check in enables the patient to be alerted during the procedure as to specific medications or liquids that must be ingested at the specified times Once a regimen is selected from the regimen library during the patient check in stage before capsule ingestion the schedule of instructions are programmed into the PillCam recorder for that particular procedure in a numbered sequence
131. g RAPID Videos RAPID Viewing user guide e Creating a PillCam Capsule Endoscopy Report RAPID Report user guide Loading a Study with the Study Manager The Study Manager allows you to conveniently access and manage patient studies The studies are organized in the Study Manager in a way that enables easy access and management of studies sorting and searching by different criteria such as patient name and procedure dates The Study Manager connects to a directory of studies called an Archive at different locations 1 e on the local computer or on a network on a removable drive connected to the computer or on a CD DVD containing the studies These studies are represented in a multi line format where each line represents a separate capsule procedure To access the Study Manager e From the Home screen click Li View Study and select Study Manager in the drop down list RAPID sica E Panen Checkin y Recorder Download B View Study O a Y A GlyEN IMAGING e From one of the RAPID screens click File gt Study Manager or click the Study Manager icon FEE located on the Quick Access Toolbar Given Imaging 75 PillCam Capsule Endoscopy 76 The image below displays the Study Manager layout divided into the following sections e Archives e Studies e Status Bar e Action buttons eo Search Study Manager Archives Search a ES a rr e E 1cD Code Mde fin
132. ge Viewing for COLON 2 videos only RAPID Settings Configuring RAPID Software Report Tab From the Home screen select Tools gt Settings Then select the Report tab After making the changes to the settings click Apply to accept the new settings or click Cancel to close the Settings screen without accepting any changes Clicking OK will accept the new settings and close the Settings screen Settings Report Templates Configure the available templates for report generation Select Report template file name Template Name Image M Localization Progress Indicator Image M Localization Progress Indicator Y Image M Localization Progress Indicator Image M Localization Progress Indicator Y Image M Localization Progress Indicator Image M Localization Progress Indicator Y Image M Localization Progress Indicator Image M Localization Progress Indicator PA Request electronic signature Results Export FT Include video clips in export data RF Export to directory Patient Summary Export Include video clips in export data Export to directory Regimen format gt Print in pocket format Print in page format System Wide OK Cancel Apply RAPID Settings 141 PillCam Capsule Endoscopy Report Templates Section To configure which of the pre loaded templates will appear ready to use in the drop down list in the Report ribbon go to Home screen gt
133. ge columns aid 81 Manual Data EM y ici 28 manual discharge oocccncnoccnnnnnonocnninonocononos 166 Mark ATOW aiii 107 Mare Circles ate n NTA 107 Markina tool S erena e T 107 markings on thumbnails cccccceee eee 107 menu commands PS A E E 91 metal ODI SCIS is EEE 15 MOSAICO VIEW oriditosar iia ATA EEEO 96 AIR AA E 6 MRI device ca ico 6 19 MRT dEV CE ts ias 24 Multiple Procedures DR2 occcoocccnnnnnoconnnnn 60 N NAUSEA pd dao o 6 19 navigation buttons cccooooccnnncnoconononoconnnnnonos 48 206 O obscuro DiSSdina cesar tibias 5 OTPINE A eE 88 One thumbnail comparison 000008 113 P pacemakers sd 6 A A 43 58 paining a capsula 43 pairing before capsule ingestion 59 Pairing during patient check in 58 PASSAGES IES Suar iia 112 DA da ales 5 Patient Check In seta dis 16 Patient Check in ia 24 Patient Check In Wizard cccccccceeseeeeeeees 26 Patient Guidelines general ceccceee eee 23 Patient Instructions creating ceeccceeeeee 22 Patient preparing ccsdousicsaadesdecadvsionsGonsiscuedess 19 Pediatrie patients 0 ios 4 POOL iia 5 PillCam Capsule Endoscopy sseccceeees 13 PillCam Capsule Endoscopy Process 13 Plica Capsules nd 13 PillCam Progress Indicator oooomommmmmos 111 PillCam Recorder DR2 troubleshooting cooooocccnnnnocnnncnononnnnnos 172 PillCam re
134. harge level Capsule signal level Status line z 4 132358 Oe Recorder status unpaired Patient name A John Smith Capsule type U COLON Last Regimen instruction _ ij 12345 a Icon to toggle delay AUCO AEE GONO M rs instruction After pairing with the capsule the display shows the relevant procedure information data as follows Battery charge level Capsule signal level Status line ___ _ a 8 12 35 Recorder status paired Patient name 5 John smith Patient D ___________ 12345 Capsule type 2 COLON2 C8PASLZ M 01234 Last Regimen instruction Audio alert control To activate real time viewer only after pairing use navigation buttons located under the bottom icons on the display press the button below the camera icon then the right button and then the left button When a regimen instruction alert is activated the instruction number appears all over the main screen and remains until the Acknowledge button is pressed The graphic indication in the top right corner of the displayed alert indicates that an acknowledge response is required by pressing the acknowledge button 2 81 12 20 AFR A John Smith 12345 7 Regimen reminder alert Error messages appear similarly over the main screen see Error Messages on page 52 PillCam Recorder DR3 47 PillCam Capsule Endoscopy 48 LED Display T
135. he check box De identify at the bottom of the screen Any reports created for this study also will be included in this export so make sure that sensitive data 1s already de identified if needed see Report Ribbon on page 117 Using the Study Manager 85 PillCam Capsule Endoscopy 86 4 Click Next Select destination archive Archive Click the relevant USB icon and click OK A screen appears showing the progress bar and Exporting study When the progress bar is full the last screen appears with the message File export successful Click OK Only after saving data on a USB storage device is complete take special care to correctly unplug the device Improper removal of a USB device may cause loss of data and computer instability To safely remove a USB storage device 1 2 3 Click the icon lo on the left side of the screen to select the USB storage device Click Eject When the message that you can safely remove the hardware appears unplug the USB storage device Saving a Study as a Zip File The Zip function of Study Manager uses WinZip to zip the files a measure that ensures all files in a RAPID study stay together for convenient handling such as sending by email To zip files 1 2 Select the relevant study and click Export Select either Entire study or Specific files under Select data to export If you select Specific files a window opens inside the screen showing the files for selec
136. he disc Click and drag the files you wish to copy to the disc over the Drag to Disc screen A progress bar appears to indicate the burning process Once the progress bar has disappeared click 4 _ on the Drag to Disc screen to eject the disc The following screen appears Eject Options a x a Mi g ES A Drag to Disc How would you like Drag to Disc to prepare this disc For Future use Leave the disc open Use the disc on this computer or on computers with compatible Drag to Disc versions Close the disc Prepare the disc to be used without Drag to Disc Make the disc read only Advanced settings e Show eject options when ejecting a disc E Cancel Help If you wish to add files to this disc later multisession click the top option and click Eject DirectCD 5 To burn a procedure 1 2 3 4 Insert disc into disc drive Double click the DirectCD icon on the desktop In the DirectCD screen click Format The Format screen appears In the Label box enter a name for your disc limited to 11 characters This is the volume name in the Study Manager Click Start Format The DirectCD formats the disc Additional Settings 161 PillCam Capsule Endoscopy Once formatting is done the disc behaves like a regular folder and you can save videos findings and reports to this folder and the software will burn the CD You can add more files anytime later Keyboard Shortcuts
137. he following message appears when opening the video No gastric to SB passage detection was found in this video In this case the video is very short the first 3 minutes only e Some patients may require close supervision to ensure they comply with post ingestion instructions Other patients may be able to function independently as long as they have access to all needed doses of laxatives and or prokinetics and are capable of following instructions during the procedure When in Real Time viewing the PillCam recorder screen turns off and returns to the main screen after e 2 minutes of inactivity for COLON procedures SB procedures e 30 minutes of inactivity for ESO procedures NS Note AFR should be activated only after visually confirming entry into the small bowel Real Time Viewing with PillCam Recorder DR2 Only External Mode To activate real time viewing with external RAPID Real Time viewer connect either PillCam recorder model you are using to the external real time viewer through the respective USB cable 64 Real Time Viewing with PillCam Recorder DR2 Only External Mode Performing PillCam Capsule Endoscopy and activate the RAPID Real Time viewer For instructions on the operation of the RAPID Real Time viewer see the user manual for RAPID Real Time viewer Removing Equipment from the Patient If the patient has not already removed equipment do so as follows 1 2 3 4 5 Disconnect the sensors from the P
138. he top of the PillCam recorder has a small screen on which the capsule and message LEDs are displayed These LEDs indicate the status of the PillCam recorder and the capsule endoscopy procedure For example when the capsule LED on the PillCam recorder blinks in blue this means that PillCam recorder is receiving data from a capsule Capsule LED Message LED For a complete list of all capsule and message LEDs see PillCam Recorder DR3 LEDs on page 50 Acknowledge ACK Button Designated for Patient Use During a capsule endoscopy procedure patients press the Acknowledge button in response to PillCam recorder message alerts that appear on the recorder display This ensures that the patient acknowledges the instruction message This can include regimen instruction messages during post ingestion regimen see Post Ingestion Patient Instructions on page 151 e The acknowledge button will simultaneously blink with the display of any regimen re minder popup in PillCam recorder DR3 LCD display and it will keep blinking until patient pressed the acknowledge button for 3sec or the popup display has reached its time out duration e Atthe end of 3 sec continuous pressing on the acknowledge button the blinking will go off Navigation Buttons The navigation buttons are used to interact with the recorder by moving a cursor on a menu of icons on the recorder LCD screen and to make a selection during the capsule paring process see PillCam Recorder Capsul
139. hysician You can approve a regimen only when it is opened and from within the opened regimen screen Open a regimen by double clicking it or selecting it and clicking the Open button Select pre capsule ingestion or post capsule ingestion regimens Regimen Name Approved By Approval Date Notes Dr Schnaider 2452012 2 9 1 3L MoviPrep Boosts Prokinetics 20mg Domperidone Meal at the end of procedure day is allowe Approved Regimen Picosulfate Boosts Schnaider 245 2012 1 packet 1 packet Mg SPS Boosts Prokinetics 20mg Domperidone Meal at the end of procedure day i Dr Saep Boas Dr Semad E ALG Note If upgrading the RAPID software to version 8 0 all previously approved regimens will require approval again Regimen Manager Configuring RAPID Software The buttons on the bottom of the Regimen Manager screen perform the following Button Action New Create a new regimen to add to the regimen library Open Opens the selected regimen Delete Deletes the selected regimen All regimens including the pre loaded regimens can be deleted Print Prints the selected regimen This button becomes available only after a regimen is approved Print Displays a preview of the selected regimen before printing This button Preview becomes available only after a regimen is approved Import Imports a regimen from a selected directory The default directory is designated in Settings Export Exports a regimen to a selected directory
140. ibed above So for example the template file name Localization Progress Indicator Image M would generate a report displaying the localization of GI tract with the progress indicator next to the medium sized thumbnails The report printout sample on page 127 is based on this template As another example the template Image L will display only large thumbnails without localization of the GI tract and without progress indicator After selecting the desired templates in Settings the default template name in the drop down list would be the template file name The template name can be edited by clicking once in the template 142 RAPID Settings Configuring RAPID Software name field and editing the name Click Apply or OK to save the settings The four templates selected and edited will appear in the Report tab drop down list an oic FE Select All Thumbnail O ie i j Template name Template Medium pics amp Select All Thumbnails R Po le will appear on Unselect All Thumbnails l Medium pics ss Preview Print Save Save Send as Export Report ribbon sia E Select umbnai As Attachment arge pics e Configure Fu Report Extra large pics NS Note From the four templates in the settings screen the templates can be unselected so as not to display in the RAPID software by clicking the checkbox on the left side of the template file name in the Settings screen By default one tem
141. ices with pulp Y Clear liquid diet glass and you can see Sa oa cancers through it it is OK to drink A Soup or broth clear liquid diet can include Alcoholic beverages e Water Any solid food dit Apple white grape or le cranbeny juices l Approval W Low fiber diet This Regimen is approved The regimens contain editable instructions in the Instructions for Patient column Clicking the instruction will prompt an editor Information represented in brackets 1s generic and 1s intended for completion by local staff with consideration to local names of the solution Make any changes and click OK to save the updated instruction Days Before Start End Procedure Time Time 2 days before procedure v AllDay v Drinkat least 10 glasses of fluids preferably water during the day 1 day before procedure v All Day v _ Clear liquid diet Refer to list below for details No solid food 5 K gt Instructions for Patient 1 day before procedure Instructions for Patient IEA O O OF PEG solution one OF PEG solution one age Shake well until all the powder is dissolved and keep refrigerated dditional Instructions quid Di et lt aw Allowed Not Allows If you wish to include your instructions for a liquid diet check the Clear Liquid Diet check box This will display the list of Allowed and Not Allowed food or drink items To modi
142. ield strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range NOTE 5 Interference may occur in the vicinity of equipment marked with the following symbol K a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the PillCam capsules are used exceeds the applicable RF compliance level above the PillCam capsules should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the PillCam capsules b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Guidance and Manufacturer s Declarations 195 PillCam Capsule Endoscopy Recommended separation distances between portable and mobile RF communications equipment and the PillCam COLON 2 capsules The PillCam COLON 2 capsules are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the PillCam COLON 2 capsules can help prevent electromagnetic
143. illCam recorder Remove the PillCam recorder from the patient Remove the sensors from the patient Remove the PillCam recorder from the pouch and place it in the cradle After each procedure make sure to clean the equipment see PillCam Sensor Maintenance on page 167 and charge the PillCam recorder see Charging on page 165 Removing Equipment from the Patient 65 PillCam Capsule Endoscopy 66 Removing Equipment from the Patient Chapter 7 Creating RAPID Videos PillCam Recorder Download After the capsule endoscopy examination the video data in the PillCam recorder must be copied to a computer and compiled into a video There are two ways of doing this Copy the data and compile the video as a single task This method is the default it is very convenient but takes longer to complete and free up the PillCam recorder Copy the data only and perform compilation later This method requires some additional steps but makes the PillCam recorder available faster see Copy Data from a PillCam Recorder on page 71 When creating a video the RAPID software Given Imaging Creates a folder for the new video This folder is inside the preset default folder see RAPID Video Files on page 114 Displays the images being copied from the PillCam recorder during video creation Creates the RAPID video from this raw data and saves it in the new folder The new video name and its folder name are the same Notifies you once the vid
144. ils appear in the thumbnail section with the captures First Duodenal image and First Cecal image 2 Double click the suggested thumbnails for review 3 To accept the suggested landmarks right click the thumbnails and select the appropriate landmark option Localization Localization provides the approximate location and track of the PillCam capsule in the GI tract via a two dimensional representation The Localization feature is available for SB and COLON videos JDS Note Localization is only available for procedures performed with a sensor array The Colon Location Diagram is available for COLON 2 videos even if performed with the sensor belt but the localization feature will not appear When at least one landmarked thumbnail has been captured and created for the first image of one of the anatomical landmarks along the GI tract the localization feature is enabled and e A sketch of the estimated track of the capsule in the GI tract in the abdomen area is displayed in gray e Asmall white circle with a black dot on the capsule track indicates the estimated position of the current frame being viewed e The capsule track is segmented into the GI tract segments according to user landmarking stomach small intestine large intestine The part of the GI tract that is already viewed becomes colored according to the same color codes as on the lower part of the time bar as follows 110 Using RAPID to View a Video Reviewing and In
145. in this configuration There is no need to use any control button of the recorders 56 Connecting a PillCam Recorder to a Personal Computer PC Chapter 6 Performing PillCam Capsule Endoscopy Setting Delay First Instruction in PillCam Recorder Before ingestion of the PillCam COLON 2 capsule you need to make sure that the settings match the procedure circumstance patient stays in clinic after ingestion or is instructed to go home immediately If the patient stays in clinic the Delay First Instruction flag on the PillCam recorder DR3 needs to be OFF otherwise it needs to be ON If this flag has not been set properly during check in 1t needs to be set before ingestion directly on the PillCam recorder prior to pairing with the PillCam COLON 2 capsule by using the right navigation button with the icon above it to toggle the flag The default setting for a PillCam recorder DR3 checked in by a RAPID v8 without changing the Delay First Instruction field during check in 1s ON first instruction delayed Repetitive use of the right button will toggle the status of the PillCam recorder DR3 and its status will show in the fourth icon from above in the left most side of the fourth procedure data line o mesg T John smith E 12345 COLON Gi 12345 Delay First Instruction off The fourth line status icon and the button designation icon in the lower right corner of the screen above the right navigation button will always be opposite After
146. int the Patient InstrUCIONAS ss adi roo dinit 153 Print Layout of the Post Capsule Ingestion InstructiONS oocccocncocnconncccnoncnnnonnnos 154 Additional SCHININI 156 Backup Restore Offline Studies oocooccconcoccconiccnoonoconcncnonoconoconnnnnnnnonnonanonnonannnnonano 156 IMPONG TRE DONS ista can e A a de 158 Freeing Space on Your COMpulteT cooccoccccccnccccnconcconoconocononcncononcconnonannonocanrnnnnanonnnnanennnnas 159 BACKUP System OG St o Lei 160 SID FN DB URN Quesada listas 160 Keyboard hoc Sauna A 162 Table of Contents PillCam Capsule Endoscopy Appendix A3 PillCam Equipment Maintenance ccccceececeeceeeeneeeseeeeeeeeenseneeneeeeeeens 163 PillCam Recorder Maintenance siii 163 Mportantsately INSTRUCTIONS susto 163 PCan Recorder DAS 164 e A aaa 165 PING AN Sensor Maldtenance iii 167 Cleaning the PillCam Sensor Belt ooocccoccconcconoconoconoconoconoconononononoconocanonanenanonanoss 167 Cleaning the PillCam Sensor Array ns 167 Cleaning the Recorder POL init ia 167 Appendix A4 TFOUDIGCSIOOUING mita iii 169 RAPID VMIACO isis is 169 Saving and Opening Video nica a ic diia 169 a 170 CDID VD a 170 A A A 170 Sensor Belda ao ccistaios 171 CAPSULAS ia Sd 171 A cece es wate cisco E E O aebasegioese taneoe 171 PIN Calm Recorder DIRS iii ici ibd 171 PING Aly Recorder DR 172 EMOr Mess ad Sian dotadas 173 SOW 351 IN alii cito 173 Appendix A5 Technical Description n
147. interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the PillCam COLON 2 capsules as recommended below according to the maximum output power of the communications equipment For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 196 Guidance and Manufacturer s Declarations Technical Description PillCam Recorder DR2 C Guidance and manufacturer s declaration electronic emissions The PillCam recorder DR2 is intended for use in the electromagnetic environment specified below The customer or the user of the PillCam recorder DR2 should assure that it is used in such an environment The PillCam recorder DR2 uses RF energy only E for its internal function Therefore its RF RF emissions ae l Group 1 emissions are very low and are not likely to CISPR 11 l cause any interference in nearby electronic equipment RF emissions CISPR 11 eee The Pil
148. ion 1 2 3 To use Polyp Size Estimation 1 2 From the Home screen select Tools gt Settings The Settings screen appears Select the Video tab and in the Research Tools section click the checkbox next to Enable Polyp Size Estimation Research Tools Enable FICE Viewing V Enable Polyp Size Estimation Enable Collage Viewing Click Apply or OK Click in the ribbon Place cursor at one end of a polyp Click and drag without releasing to create a double pointed arrow from one end to the other end of the polyp for which you wish to estimate the size The size estimate appears at the end where you release the mouse button If you make more than one size estimate for the same image the estimates are counted 1 2 etc To remove a marking click the Undo Mark button The last marking disappears Click repeatedly to successively clear all marks Using RAPID to View a Video Reviewing and Interpreting RAPID Videos JPR Note The Polyp Size Estimation tool is intended to estimate polyps only and should not be used for estimating the size of other pathologies or dimensions Using Localization and Landmarks Landmarks Landmarking an image labels it as one of the anatomical landmarks along the GI tract A different default landmark menu is displayed for each RAPID video type as follows Video type Landmarks ESO video first esophageal image Z Line image first gastric image SB vide
149. ived from Patient Check In information transferred from the PillCam recorder during the video creation e Patient s last name Patient s middle initial Patient s first name Patient s ID number in parentheses Examination date in the following format DD MMM YY YY For example the RAPID folder with the name Doe F John 12345 21 Feb 2008 which resides in E videos contains the file named Doe F John 12345 21 Feb 2008 gvi You may save a RAPID folder and a RAPID video to a removable media USB storage device or disc for one of the following reasons e to back up a RAPID study e to copy a RAPID study from the hard disk in order to free space on the computer e tomoveacopy of a RAPID study onto another computer or to another physician To save a RAPID study to a CD DVD see Saving a Study to a CD DVD on page 83 To save a RAPID study to a USB storage device see Saving a Study to Another Archive on page 85 RAPID Video Files Reviewing and Interpreting RAPID Videos Working with Findings A findings file contains all the thumbnails with their comments or other annotations see Creating and Annotating Thumbnails on page 103 a link to the check in information all the study comments see Editing Tools on page 105 a link to the report if created Saving Your Findings It is possible to save your findings You can open and view this file with the RAPID video on any computer with the RAPID software installed A N
150. k the Raw Data Files tab Find the bar that corresponds to the USB storage device you want to select The relevant patient information 1s displayed on the button 4 Click Create Video 5 After a video has been created click Safely Remove to safely remove the USB storage device PillCam Recorder Download 69 PillCam Capsule Endoscopy Batch Video Creation RAPID can perform multiple video creations for any combination of up to four PillCam recorder cradles and for any number of raw data files Once the process begins the videos are created consecutively From PillCam Recorders Place PillCam recorders into the connected cradles In the Recorders screen click Create Video for each one separately The order in which you click Create Video determines the order in which the videos are created If you cancel one of the video creations after activating it this PillCam recorder is skipped and the next one starts automatically From Raw Data Files USB Storage Devices Connect USB Storage devices In the Raw Data Files screen click Create Video for each one of the devices or any raw data files already on the computer The order in which you click Create Video determines the order in which the videos are created If you cancel one of the video creations after activating it this raw data file is skipped and the next one starts automatically Pause End Video Creation During video creation the End Video Creation button becomes available
151. l Description Mouse over a thumbnail without effects gives it a light blue background Also a checkbox becomes available a the top left corner for selecting the thumbnail for the report as well as the edit button in the top right corner Thumbnail Comments To add a comment to a thumbnail use one of the following methods e Click the check box Comments Editor in the ribbon of the View screen e Right click the thumbnail when in the View or Report screen and select Edit Thumbnail Comment e Hover over the thumbnails and click a in the top right corner of the thumbnail to open the thumbnail editor Comments Editor The Comments Editor at the left side of the screen enables the user to type in their comments about a specific thumbnail or about the whole study E Note You can toggle to and from right to left writing as supported by Windows convention by pressing the ALT and SHIFT keys simultaneously Editing Tools When typing comments in the comments editor the following two tools are available e GI Dictionary simplifies efficient report creation via a pre populated and customizable database of terms and phrases RAPID software preserves the GI Dictionary customizations from previous versions during software upgrade My GI Dictionary abdominal abnormal active bleeding ampulla of vater anastomosis a Type a part of a word anywhere during text editing on the screen b The dictionary is context sensitive and sh
152. l if it is known and click Next f Delete Mandatory field Procedure Information Normal Protuberant Abdomen Mandatory field 13 Click Next 30 Performing Patient Check in Preparing for PillCam Capsule Endoscopy 14 Complete the protocol and materials details Procedure Information Protocol number Procedure information O Initialization Capsule lot number Sensor serial number Battery pack serial number Recorder serial number Mandatory field cll EA ll so gt 0 a A Click Next to continue Fill in Protocol number or Name if you are performing a clinical trial For Capsule lot number enter the LOT from the back of the capsule box For Sensor serial number enter the SN from the sensor array cable For Battery pack serial number enter the DR2 recorder battery pack serial number For Recorder serial number enter the PillCam recorder serial number 15 In the Procedure Information Confirmation screen verify that the patient and procedure data is correct Procedure information Procedure Date O Initialization Gender Birth Date Procedure Capsule ID uni 2 In Cc aa Mi Katerine Dalven 8990763 24 May 12 Female 11 Apr 61 SB2 e Ifthe data is incorrect click Back and return to a previous screen to correct the mistake e Ifthe data is correct select Accept and then click Finish
153. l for generating pre capsule ingestion regimen instructions to give to the patient before the day of the procedure and post capsule ingestion regimen instructions for the patient to follow during the capsule endoscopy procedure The Regimen Manager allows the creation and maintenance of a library of different instruction sets appropriate for different circumstances to choose from The post capsule ingestion regimen instruction set is selected during Check in from the regimen library The instruction set is uploaded to the PillCam recorder DR3 and is used for creating timely alerts to the patient during the procedure Currently only procedures using the PillCam recorder DR3 with PillCam COLON 2 capsule utilize regimen instructions during the procedure This section gives an overview of the Regimen Manager tool as well as the following e Regimen Manager screen layout Pre capsule ingestion regimen Post capsule ingestions regimen Editing and saving regimens Printing regimens for the patient Using the Regimen Manager To access the Regimen Manager from the Home screen select Tools gt Regimen Manager The Regimen Manager comes pre loaded with several pre and post capsule ingestion regimens for you to use Any regimen to be used must be in an approved status by the user None of the pre loaded regimens in the library are in an approved status Any regimen in the library to be valid and selectable in the menu must be reviewed and made approved by a p
154. lCam SB video The Suspected Blood Indicator SBI feature 1s a guide to areas of suspected fresh GI bleeding The SBI display feature becomes available only from the first duodenal image on Hence the SBI feature is available only after labeling the first image of the Duodenum When SBI is activated red ticks appear above the time bar and they indicate the location of SBI images 0 2 00 3 00 4 00 5 00 6 00 7 00 8 00 SBI lines are not displayed in the area before the first duodenal image which becomes gray To display the SBI images 1 Identify and label the first image of the duodenum see Using Localization and Landmarks on page 109 2 Click 9 The video navigation buttons turn red PHOOOLE 3 Use the video navigation buttons to view the SBI images Time Bar Color Bar The Time bar Color bar displays e The total length of the video and the average color for easy anatomical segmentation of the corresponding image The unit of time is hours minutes and seconds e The slider moves along the time bar as the video is played You can also use the slider to move the video forwards or backwards e Moving your mouse over the time bar displays the time at the position of the cursor If the mouse stays at a location on the time bar for longer about 2 seconds the image at that location is displayed in a small window with the time indication of that image at the top If the video is in dual head view ESO or COLON t
155. lCam recorder DR2 is suitable for use in Harmonic emissions Class A all establishments including domestic IEC 61000 3 2 establishments and those directly connected to Voltage fluctuations the public low voltage power supply network that Meteromestone Complies supplies buildings used for domestic purposes IEC 61000 3 3 Guidance and manufacturer s declaration electronic emissions The PillCam recorder DR2 is intended for use in the electromagnetic environment specified below The customer or the user of the PillCam recorder DR2 should assure that it is used in such an environment Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrostatic discharge 6 kV contact 6 kV contact ESD 8 kV air 8 kV air IEC 61000 4 2 Electrical fast fate OR POWEE steely pel lor Pawel supe Mains power quality should transient burst be that of a typical commercial or hospital 1 kV for input output 1 kV for input output oo IEC 61000 4 4 lines lines Mains power quality should be that of a typical commercial or hospital environment Surge 1 kV line s to line s 1 kV line s to line s IEC 61000 4 5 2 kV line s to earth 2 kV line s to earth Guidance and Manufacturer s Declarations 197 PillCam Capsule Endoscopy Guidance and manufacturer s declaration electronic emissions lt 5 Uy lt 5 Uy Mains power quali
156. lCam video capsule localization 1s based on off line processing of the strength of the radio frequency signals emitted from the PillCam video capsule as received by each of the eight sensors The information helps estimate the relative two dimensional location of the PillCam video capsule with respect to the umbilicus e g abdominal quadrant The localization software was studied in a series of 17 healthy subjects Multiple fluoroscopic images 92 sets were obtained at various times during the PillCam video capsule s passage through the small bowel The location was assessed in two dimensions relative to the umbilicus and then compared to the position obtained from the localization software When compared to the relative two dimensional location determined fluoroscopically approximately 87 80 92 of the PillCam video capsule estimates were within 6cm a fist The mean error for PillCam video capsule localization was found to be 3 8 cm The Suspected Blood Indicator SBI feature is intended to mark frames suspected of containing fresh blood The feature may be activated only after labeling the first duodenal image and marks frames contained only within the small bowel The SBI feature should not serve as a substitute for a physician s complete viewing of the video but rather to provide supplemental information afterwards All events marked by the SBI feature should be carefully reviewed by a physician In a review of 27 patients with at least
157. large vitamin pill There are three PillCam capsule types supported by the current PillCam endoscopy system Each is optimized for a different bowel segment some with one video head and some with two video heads Given Imaging 13 PillCam Capsule Endoscopy PillCam SB capsules gt Pp ep small bowel IG Pillcam cn qua Cu PillCam ESO capsules E 6 A esophagus i Pillcam p BPillcam gt PillCam COLON capsule d a Ja colon Beilen PillCam SB capsules contain one video camera PillCam SB2 is a fixed frame rate second generation capsule while PillCam SB3 1s a third generation capsule with enhanced imaging capabilities with adaptive frame rate AFR PillCam ESO capsules contain two video cameras one at each end They also have two variants PillCam ESO 2 fixed high frame rate and PillCam ESO 3 with enhanced imaging capabilities and fixed high frame rate PillCam COLON capsules contain two video cameras one at each end The PillCam COLON 1 variant is a fixed frame rate capsule while the PillCam COLON 2 variant is an enhanced imaging capability adaptive frame rate AFR variant After activation and ingestion the capsule is propelled by peristalsis through the gastrointestinal tract During this process the video cameras acquire images and the transmitter sends them via the sensors to the PillCam recorder for storage For full technical specifications of PillCam capsules see System Specificati
158. le is open RAPID asks is you want to save the current findings file The Open Findings File window appears Working with Findings 115 PillCam Capsule Endoscopy showing the folder of the current video A findings file can also be opened using the Study Manager see Open on page 83 Videos Moniager Derek 5558976627May00 MN Q Findings AllLandmarks i Select the findings file you wish to open To open a findings file stored in another location navigate to the desired location by clicking Browse Click Open Once the findings file is loaded the saved thumbnails with their annotations appear in the Thumbnail section If the findings contain landmarks the following note appears Calculation of passage times for the esophagus stomach small bowel and colon is based solely on your selection of the first images of the esophagus stomach duodenum cecum and last rectal image as you have defined them Click OK to continue Creating a PillCam Capsule Endoscopy Report 116 Overview After viewing the capsule endoscopy video and creating the findings an interpretation of the study can be summarized in a patient report This phase should be performed after the Preview and Review phases The data created during the Review phase is now stored in the corresponding video folder The RAPID software s Report ribbon enables the creation of reports and exporting of video clips and images to another directory or to a
159. ll bowel e The left of the screen is divided into three tabs relating to video tertiles A tertile is one third of the small bowel as calculated by the transit time of the PillCam capsule in the small bowel The 1st SB Tertile is the proximal third the 2nd SB Tertile is the middle third and the 3rd SB Tertile is the distal third of the small bowel 2 Select the tertile you are referring to by clicking the appropriate tab The selected tertile on the color bar and the thumbnails selected within it are in color whereas the rest of the color bar and thumbnails are darkened 3 Under Villi select the appropriate e degree of Appearance e length of segment for Longitudinal extent e correct Distribution Lewis Score Reviewing and Interpreting RAPID Videos 4 Under Ulcers select the appropriate e Number e length of segment for Longitudinal extent e correct range for Circumferential extent 5 Select the next tertile and repeat 6 Under Stenosis select e the appropriate Number e Yes or No for Ulcerations e Yes or No for Traversed The Lewis Score at the top of the screen updates automatically Lewis Score Glossary Appearance of villi Edema where width of villi is equal or greater than height of villi Evaluated villi in mucosa distinct and separated from an ulcer rather than contiguous to a mucosal break Circumferential Extent Portion of the entire image involved by the lesion based on the entire lesion in
160. llCam recorder for the capsule endoscopy procedure by entering patient data Preparing the Required Equipment 21 PillCam Capsule Endoscopy Button Action Copies the raw video data to the computer This button only appears after unchecking the checkbox Disable Video Data Management in the Video tab of the Settings screen see Video Data Management Section on page 140 Not available for RAPID Reader Starts or stops video creation from the raw data on the PillCam recorder ai Displays all technical details of the PillCam recorder Creating Patient Instructions for the Procedure 22 Patient Instructions are handouts used to guide the patient in preparing for the PillCam capsule endoscopy procedure NS Note When performing check in with RAPID v8 video download must be done using RAPID v8 Pre ingestion Instruction Handouts SB procedure goes with predefined pre ingestion instruction text ESO procedure also goes with predefined pre ingestion instruction text Colon procedure goes with customizable pre ingestion instructions that can be created by the physician using the Regimen Manager tool In general pre ingestion bowel preparation for PillCam capsule endoscopy of the colon includes cessation of iron supplement intake several days before capsule ingestion then adherence to a Clear Liquid Diet starting from at least a full day before capsule ingestion to be followed by customizable laxative intake with wat
161. lly one of the procedures displays a highlighting on the Findings Right clicking the study and selecting show all search results displays additional information regarding the text searched Active Bleeding and where it is located In this example the Active Bleeding text was located in the Findings under the Reason for Referral Results found in Study Capsule Type SB Results found in Findings File name AllLandmarks grml Directory C Videos CRT _ 194 1 07 Jan 09 1 Procedure Information and Findings Active and inflammation Additionally if opening deleting or exporting the study the finding will remain highlighted to allow for its selection as shown below i m7 o la A To clear the search fields and again see all studies in the selected archive click Reset To refresh the search view click Refresh to ensure that the latest data 1s displayed in the Study Manager Loading a Study with the Study Manager Reviewing and Interpreting RAPID Videos Managing Columns You can determine what information is displayed about each study By default Study Manager displays the following columns containing information entered during the Check in process e Last Name e Referring physician e First Name e Ordering physician e ID e ICD Code e Gender e Video created e Capsule type e Findings e Procedure date e Report These columns are mandatory and cannot be changed or removed There are also columns that you can op
162. lose Video Click to open the Study Manager Click to load recently viewed video or hover over the button to display recently viewed videos to choose from Hover over the button to User Dictionary display secondary commands Export Additional Tools a Delete Videos gt 4 Import RAPID 4 Reports 91 PillCam Capsule Endoscopy 92 Button Menu command Secondary commands Click the Help button to Help Help Hover over the 2 Online Help button to display secondary commands oO Help Center e About Customer Support wm Contact Us APA Collect Analysis Files El Ne A RAPID Log View Screen The View screen is used for viewing videos created from PillCam capsule endoscopy procedure It is accessed by clicking the View tab The View tab in the RAPID software allows for viewing the RAPID video marking and annotating thumbnails of interest and adding any comments to the study The View screen enables the following functions to review the patient study Preview and review the patient procedure video using the RAPID video player Use viewing layouts and image adjustment features to enhance or to focus on the video image Annotate thumbnails for later viewing and commenting Designate thumbnails as anatomical landmarks GI tract Use the Localization feature to show the localization track and display the gastric passage times Display Progress Indicator to show viewing progress of the small bowel Overvie
163. low according to the maximum output power of the communications equipment For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Guidance and Manufacturer s Declarations 203 PillCam Capsule Endoscopy 204 Guidance and Manufacturer s Declarations A abdominal palh dnd 6 19 Acknowledge button occccooooncnnnonononnncnanonoss 48 action buttons Study Manager 00608 79 adaptive frame rate AFR cooonccnnnnocccnnnnnnos 14 adhesivos Seven 33 adio InterferencCe ooccococcnnononnnncnnnncnnnanononacnnnnos 7 Adverse Events rada e 5 AFR mode cccceeeee 48 51 63 95 111 amateur radio transmitters ooccoocnoccncnconnncnnns 7 ARCHIVO A A 76 ATEOS Os 76 archives OPUIONS ni aves El ASIA aaa iibi 5 O e du coerauneaeta le desesteceataieaese 17 Automatic shutdown o cccconoccnnnnnoronnncnononoss 53 B battery Operated is 15 PS E E A A E A A A E on 96 C capsule troubleshooting
164. ly or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Uy is the AC mains voltage prior to application of the test level Guidance and Manufacturer s Declarations Technical Description Guidance and manufacturer s declaration electromagnetic immunity The PillCam COLON 2 capsules are intended for use in the electromagnetic environment specified below The customer or the user of the PillCam capsules should assure that it is used in such an environment Portable and mobile RF communications equipment should be used no closer to any part of a PillCam capsule including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Conducted RF 3 Vrms Recommended separation i distance IEC 61000 4 6 150 kHz to Not applicable Bi 80 MHz d 1 2 P Radiated RF d 1 2 P 80 MHz to 800 MHz MHz range IEC 61000 4 3 d 2 3 P 800 MHz to 2500 MHz NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NOTE 3 P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m NOTE 4 F
165. m as shown below Each capsule 1s marked with the expiration date lot number and a unique capsule ID code G 123 ABC 1 LOT SM ooo DAME Mw 01141111111111111 1 11 10 11111XX 1111 Expiration 33 XXXX XX XXXXXXL Date Ji xxxx xx ILOT lt FCC ID O8PGIVENIMAGING Rx Only Capsule ID Code Road Given Imagin 3950 Shacklef 123 ABC 1 Duluth GA 30496 USA LBL 1195 02 Lot Number Essential Performance PillCam Capsules ON Mode Data transmitting to PillCam recorder is considered to be essential performance of the PillCam capsules The PillCam capsules shall transmit data continuously monitored by on line image display as received by PillCam recorder OFF Mode No unintentional transmissions are allowed PillCam Recorder DR2 and PillCam Recorder DR3 Data receiving by PillCam recorder is considered to be essential performance of the PillCam recorder DR2 and PillCam recorder DR3 Warnings e PillCam Capsule Endoscopy System and its components need special precautions regarding EMC and need to be installed and put into service according to the EMC information provided in the accompanying documents e Portable and mobile RF communications equipment can affect the PillCam video capsule and the PillCam recorder e PillCam video capsules and PillCam recorder should not be used adjacent to or stacked with other equipment and that 1f adjacent or stacked use 1s n
166. m recorder after the raw data is copied without waiting for full video compilation You must manually clear raw data files because this video creation method can rapidly fill up your hard drive You can change the following directories by typing the desired location or clicking Browse to select a folder Video directory destination location for created videos e Raw data directory destination location for copying raw from the PillCam recorder You can also enable the following feature with the video by selecting the check box Allow manual mode for non SB3 with DR3 procedures Video Data Management Section To enable video data management 1 2 3 4 From the Home screen select Tools gt Settings Select the Video tab Under Video Data Management Disable video data management is selected per default Select e Copy raw data copy data ONLY This takes less time so the PillCam recorder is freed up sooner The copied data can later be processed to create a video e Compile raw data process for video creation Click OK to accept the new settings or click Cancel to close the Settings screen without making any changes Research Tools Section To enable video research tools L 2 3 From the Home screen select Tools gt Settings Select the Video tab Under Research Tools select e Enable FICE viewing for SB and COLON 2 videos only e Polyp Size Estimation feature for COLON 2 videos only e Enable Colla
167. mages is presented in a clockwise fashion Overview of the RAPID Interface 95 PillCam Capsule Endoscopy Button Function Mosaic view Shows the video in Mosaic view which displays 18 consecutive frames on the screen The order of the images is from top to bottom for each column moving from left to right ii Mosaic view is not intended for diagnostic review and should not be used as a substitute for reviewing the video in one of the other layouts Image Adjustment Group This ribbon group contains the controls for preset or custom adjustment of the displayed video image This includes controls adjusting for sharpness brightness color and FICE or Blue processed image Button Function Turns Image Adjustment off Y On Turns Image Adjustment on Adjust Opens the Image Adjustment screen Image Adjustment provides an alternative image view via a single click using proprietary technology with enhanced sharpness and contrast Sharpness Color and Brightness controls enable customizing of the image to user preferences When clicking the Adjust button the following screen appears Click on the buttons labeled FICE or Blue for pre set image enhancements Use the sliders to adjust the sharpness brightness and color of the image 96 Overview of the RAPID Interface Reviewing and Interpreting RAPID Videos Button Action No image adjustment FICE 1 FICE 2 or FICE 3 FICE viewing tool aids the read
168. mbnail ra Deletes selected thumbnail Clinical Tools Buttons Group The Clinical Tools button group provides access the two diagnostic tools the RAPID Atlas and the Lewis Score that are available in RAPID RAPID Atlas RAPID Atlas enables side by side comparisons of an image in a video to validated reference images with Atlas reference images It provides a database of Capsule Endoscopy images from case studies Reference images are searchable by Capsule Endoscopy Structured Terminology CEST by Diagnosis or by Lewis Score terms Current image from Atlas images the video RAPID Atlas 4 0 1 i a E e A Current Image Atlas Images Small Bowel 482 entries found Categories of the Atlas images RAPID Atlas 121 PillCam Capsule Endoscopy There are three ways to reach the RAPID Atlas e Home screen click Tools gt Atlas RAPID sice XA Patient Check in Ej Recorder Download ME View Study GIyEN Y IMAGING e View screen right click any thumbnail or video image and select Open Atlas e Report screen click the Ez button on the Report ribbon NS Note You can activate the RAPID Atlas regardless of whether or not a video is open lf there is no video open the space for the Current Image in the top left corner is left blank If there are more than six images available in the RAPID Atlas under a certain category a scroll bar appears at the bottom of the screen to allow yo
169. mputer Backing up Data When you have confirmed that the video was created successfully you may delete the raw data files from your computer We recommend this since these raw data files are very large Back up the RAPID folders which contain created videos by saving them on removable discs CD DVD or USB storage device After saving them on removable media you may delete them from the PC s hard disk if they are not to be reviewed on that PC ALG Note Make sure that the RAPID software is completely shut down before removing the PillCam recorder from its cradle Managing RAPID Video Data 73 PillCam Capsule Endoscopy 74 Managing RAPID Video Data Chapter 8 Reviewing and Interpreting RAPID Videos After completing the patient procedure and downloading the procedure data to the computer the RAPID software processes and transforms the raw image data from PillCam studies into conveniently viewable RAPID videos This section of the user manual describes the RAPID interface and how to open a study view the procedure video and then proceed to create a Report This chapter focuses on the View Study module using the RAPID interface to load a RAPID video for viewing annotating images of interest adding comments and markings to the images and finally creating a summary report The following chapter is divided into the following sections e Loading Study with the Study Manager Study Manager user guide e Reviewing and Interpretin
170. n e Study both the video and the findings either double click the line representing the study or click the study and then click the Open button at the bottom of the screen If more than one findings file is associated with the selected video a second screen opens prompting you to select the related findings file you wish to open e Video only right click anywhere in the Study Manager screen and select Open Video Only The video of the selected study opens The Settings screen enables further options for the Study Manager such as opening findings automatically Study Manager C ProgramData Application DatalGreen Imaging Study Shared data directory Manager Display capsule sub type 4 Open findings automatically e Report click Open Report at the bottom of the screen The report associated with the selected study opens as a PDF file LN Note When you open a RAPID video while another video is still open the RAPID software automatically closes the previously opened RAPID video If you made changes to the findings of the open video you are asked to save changes before closing the video Export The Export function allows you to save a study or one of its files in a different place or under a different name to reorganize your archives This includes e Burning a study or a file to a CD DVD Saving a study or a file to another archive such as a USB storage device Saving a study or a file to a specific location Saving
171. n bursting and or ignition of the battery pack may occur If the battery pack leaks and the electrolyte gets into the eyes do not rub them Instead rinse the eyes with clean running water and immediately seek medical attention Otherwise eye injury may result If recharging operation fails to complete even when a specified recharging time has elapsed immediately stop further recharging Otherwise acid leakage overheating smoke emission bursting and or ignition can occur Do not put the battery pack into a microwave oven or pressurized container Rapid heating or disrupted sealing can lead to acid leakage overheating smoke emission bursting and or ignition If the battery pack leaks or gives off a bad odor remove it from any exposed flame Otherwise the leaking electrolyte may catch fire and the battery pack may emit smoke burst or ignite If the battery pack gives off an odor generates heat becomes discolored or deformed or in any way appears abnormal during use recharging or storage immediately remove it from the 177 PillCam Capsule Endoscopy equipment or cradle and stop using it Otherwise the problematic battery pack can develop acid leakage overheating smoke emission bursting and or ignition The use of accessories transducers and cables other than those supplied or approved by Given Imaging as replacement parts for internal PillCam recorder components may result in increased emissions or decreased immunity
172. n information use only the sensor type that you defined in the check in process 7 Click Next to continue 8 For PillCam COLON 2 procedures only Select a regimen and print 1t out to hand it out to the patient before capsule ingestion Set the Delay First Instruction checkbox ON by default to determine if a predefined minimum 90 minute free of instructions period will or will not be forced between the time of ingestion and the first instruction to the patient If the delay first instruction is set the first instruction to the patient will be either alert 0 if still relevant or alert 1 If you do not set this parameter during check in it remains in its default state ON for Delay First Instruction 1 e delayed but you may set it also through the PillCam recorder DR3 before pairing the PillCam COLON 2 capsule to the PillCam recorder DR3 28 Performing Patient Check in Preparing for PillCam Capsule Endoscopy Print Regimen Mandatory field 9 Click Next to continue 10 Complete physician and insurance details Procedure Information Referring Physician Ordering Physician Check in by Insurance ICD Code Group Number J e Mandatory field Enter Referring physician and Ordering physician In Checked in by enter your name Enter Insurance Group No and ICD as required oo pyp Click Next to continue Performing Patient Check in 29 PillCam Capsule Endoscopy 11 Type in the Reason for Referra
173. nager 149 PillCam Capsule Endoscopy 150 The Notes field on the top right allows the typing of information for the specific regimen It will not appear on the printout To add an instruction to the regimen click Add Instruction and designate the appropriate start and end day and time of the instruction using the drop down lists in the adjacent columns When typing the instructions in Instructions for Patient a pop up screen appears if the text is too long Type any other information in the Additional Instructions field that will appear on the printout for that specific regimen Regimen Name 2L 2L PEG Split US aaa Background Information Approved By Dr Schnaider Approval Date 24 5 2012 Notes 2L 2L PEG split Printed Information Instructions Start End Time Time gt 2 days before procedure Drink at least 10 glasses of fluids preferably water during the day 1 day before procedure gt Clear liquid diet Refer to list below for details No solid food 1 day before procedure Ba i a Prepare ENTER LOCAL BRAND NAME OF PEG solution according to in 1 day before procedure y Drink 1 2 gallon of ENTER LOCAL BRAND NAME OF PEG solution one Day of procedure E Drink 1 2 gallon of ENTER LOCAL BRAND NAME OF PEG solution one Instructions for Patient Additional Instructions m Liquid Diet Fiber Diet Al lowed i Not Allowed a tay a If you put a liquid in a clear Ju
174. nconncnncnncnnrnnronrnnrnnnnnnrnnrnnrnnrnnrnannnnes 20 Connecting the PillCam Recorder to RAPID ooccocncccncccnconncocncocncoconooncnnnconnonononononanonons 20 Creating Patient Instructions for the Procedure ooconnccnncccncococecocenaconaconanonanenanenanenarenanenanenas 22 Pre ingestion Instruction HandoOutsS oococccoccccccocinoccccnnoncncnnnncononononnnonnnnnnnnronnnnononnnnaninnnss 22 Post ingestion Instructions for Colon Procedure oocoooccccncoccccccccocnoconononconnnnnnonanonanonanonanonns 22 General Patient Guidelines During the Procedure cccscceseeeeeeseeeeeeeeeeeeeeeseneseeeseeeees 23 Performing Patient Check i dai 24 Od ale Patent DW al e OS 32 Fitting Equipment on the Paleta cian ead 32 Applying ine Pill an Sensor Baltic a 32 Applying the PillCam Sensor Array ooccooccconcconoconoconoconoconoconocanonononanonanonononanocanenaninanenas 33 Attaching the Sensors to PillCam Recorder oocococcconccoccconcconoconoconononocononnnncanocanonanenos 38 Given Imaging PillCam Capsule Endoscopy Chapter 5 Know Your PillCam Recorder ivicinnoianriia di 43 Preparing the PillCam Recorder ainia 43 FUNCIONS anta A A A 43 lali Z AN OMe A A A yeseeadsn tan saceeatteideessaneceesecaneeec 43 A teh ate Sel get aumaecexa E A E 43 PRO TMC VIC WING a is sete echt wiereree o lira 43 REGIMEN RemiINdeFr ssp o a iii 44 DOWN o a aides 44 PinGam Recorder DR3 srice a a a a a a 44 E AA A E A AAA A A E 44 PUMN ON
175. ng any changes Clicking OK will accept the new settings and close the Settings screen ZG Note Multi user setting enables the correct electronic signature for each user login RAPID Workstation Configuration The RAPID workstation configuration is a stand alone configuration on a dedicated workstation that cannot be connected to a network environment The RAPID workstation supports multi user configuration This allows you to control access to the workstation and to make sure that only authorized personnel use the appropriate files on the workstation By default the RAPID workstation is configured for a single user with the username rapid and a blank password You can continue to use the RAPID workstation this way or you can use the multi user feature To do so the administrator person who sets up and maintains your facility s PCs creates additional users each with a unique username and password and defines the appropriate access for them Given Imaging 135 PillCam Capsule Endoscopy A user can change the password usually what the administrator creates is a temporary password by pressing Ctrl Alt Delete and clicking Change Password For Dell T3500 workstations the administrator logs in with the username administrator and password administrator RAPID Settings 136 Before you can start using the PillCam Capsule Endoscopy System you should configure the settings in RAPID These include e Information about users those p
176. nge NOTE 5 Interference may occur in the vicinity of equipment marked with the following symbol a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the PillCam recorder DR3 is used exceeds the applicable RF compliance level above the PillCam recorder DR3 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the PillCam recorder DR3 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Guidance and Manufacturer s Declarations Technical Description Recommended separation distances between portable and mobile RF communications equipment and the PillCam recorder DR3 The PillCam recorder DR3 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the PillCam recorder DR3 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the PillCam recorder DR3 as recommended be
177. niRecorder DR iva oda 197 PIUNGAM Recorder DR 200 nio gt IP gg O 205 vi Table of Contents Chapter 1 Using This Guide Conventions Screen elements such as menus button names and screen names are in bold as follows PillCam Recorders System messages appear as follows Your PillCam recorder needs an update A Note is a piece of information or a remark that receives emphasis and appears as follows BOS Note When connecting more than one PillCam recorder DR2 to the computer use a USB powered hub A Caution warns you about possible damage to equipment and appears as follows Caution Make sure that there is no other PillCam capsule or other diagnostic capsule in the patient s gastrointestinal tract A Warning warns you about possible harm to people and appears as follows Warning A N Never connect the PillCam recorder to the sensor array while the PillCam recorder is in its cradle Given Imaging 1 PillCam Capsule Endoscopy 2 Conventions Chapter 2 Indications Contraindications Warnings Cautions Indications for Use PillCam SB The PillCam SB capsule is intended for visualization of the small bowel mucosa e It may be used in the visualization and monitoring of lesions that may indicate Crohn s disease not detected by upper and lower endoscopy e It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding either overt or occult not detected by upper and lo
178. nking in red Blinking in blue PillCam Recorder DR3 Status PillCam recorder is checked in and ready to receive capsule signals PillCam recorder is receiving capsule signals before capsule pairing is achieved Blinking rate capsule frame rate PillCam recorder is receiving paired capsule signals Blinking rate capsule frame rate PillCam recorder has stopped receiving capsule signals for more than 5 seconds PillCam recorder has started downloading PillCam recorder has stopped recording because the memory card is full There is an instruction on the PillCam recorder screen PillCam recorder is malfunctioning PillCam recorder detects capsule signal but is not recording it This is a malfunction Check the sensor connection or have patient move to a different location The LEDs on the navigation buttons blink in blue every 5 seconds when the PillCam recorder is on out of the cradle and the LCD screen is off To turn the LCD screen back on press any button on the PillCam recorder PillCam Recorder DR3 Screen Icons These icons appear as recorder status on the rightmost icon of the top status line of the PillCam recorder DR3 screen 00 o G do PillCam Recorder DR3 Explanation No capsule is paired Pairing succeeded Data is not downloaded Data is downloaded Wrong sensor is connected End procedure Icon gt AFR Know Your PillCam Recorder Explanation No s
179. ns in the Instructions for Patient column Clicking the instruction will prompt an editor Information represented in brackets is generic and is intended for completion by local staff with consideration to local names of the solution Make any changes and click OK to save the updated instruction Instructions Recorder Display When HH MM Trigger Instructions for Patient 01 00 v After capsule ingestion Ingest ENTER LOCAL BRAND NAME OF 20mg DOMPERIDONE with a gl am ster 88 cetecion_ Prepare 1 packet of ENTER LOCAL BRAND NAME OF SODIUM PICOSUL 9 Any other important information can be entered in the Additional Instructions box This information will appear in the patient printout 152 Regimen Manager Configuring RAPID Software 10 When you are finished click Save This adds the regimen you created to the library of regimens available 11 By default the post capsule ingestion regimen includes at least the following alerts and instructions e Alert 0 An instruction 0 based on time passed from capsule ingestion to take prokinetics to facilitate passage of the PillCam COLON2 capsule to the small bowel Threshold of time passed from capsule ingestion for alert 0 can be modified in the regimen manager for a specific regimen e Alert 1 An instruction 1 for taking laxative after detection by the PillCam recorder of PillCam COLON 2 passage into the small bowel It coincides with the activation of the AFR mode in the Pill
180. nsufficient memory on card Sensors not connected Connect the sensors This screen appears only after pairing and before End of Procedure Cradle error Icon A 1 Name Procedure type and capsule ID Regimen Delay First Instruction status Indicator and navigation button designator Message Do not remove PillCam recorder from cradle Sensor hardware failure Consult a technician Wrong sensor type No USB connection to cradle Check connection If connection is OK and error persists consult a technician Wrong software on memory card Fatal error Consult a technician PillCam Recorder DR3 Know Your PillCam Recorder PillCam Recorder DR2 General Due to the limited number of recharge cycles and also due to wear on the electrical connectors to the PillCam sensors the PillCam recorder DR2 is limited to 350 use cycles ALG Note Once the number of uses exceeds 350 the following message appears in the log file only DR2 battery must be replaced before further use Contact customer support to arrange replacement Turning On and Off This illustration shows the front and back view of the PillCam recorder DR2 PillCam recorder DR2 Locking LED handle in Capsule LED ON OFF button open position Battery LEDs The On Off button is on the top left side on the back of the PillCam recorder DR2 e To turn on press and hold the on off button until you hear a long beep followed by a short one
181. o first gastric image first duodenal image first lleocecal Valve image first cecal image COLON video first cecal image last cecal image Hepatic flexure image Splenic flexure image first rectal image last rectal image To create a landmark Right click on video image you identify as the landmark and select the correct landmark label If for the video you are viewing you wish to enter a landmark other than the default landmarks select Capture other landmarks This option displays all the landmarks for selection Using RAPID to View a Video 109 PillCam Capsule Endoscopy Suggested Flexure Landmarks for COLON Videos This feature is available active only if a PillCam sensor array was used during the procedure If a PillCam sensor belt was used this option 1s inactive and greyed out After you have marked the first cecal image RAPID can suggest the Colon Flexure landmarks 1 Right click anywhere on the video images and select Suggest Colon Flexure Landmarks Two new thumbnails appear in the thumbnail section with the captures Hepatic Flexure and Splenic Flexure 2 Double click the suggested flexure thumbnails for review 3 To accept the suggested flexure landmarks right click the thumbnails and select the appropriate landmark option Suggested Landmarks for PillCam SB3 Videos To use this feature to suggest the SB3 landmarks 1 Right click anywhere on the video images and select Suggest SB Landmarks Two new thumbna
182. o scan the video from start to finish if you are using a PillCam SB3 or PillCam COLON 2 or PillCam ESO capsule If you are viewing a PillCam SB2 video you can select the A mode default or M mode button to set your viewing mode In all modes you can move through a video by using the navigation buttons below the video image e Play forward or backward by clicking the play buttons e Speed up or down the video display using the viewing speed slider a Speed 19 e View the next or previous image by using and e View the last image or first image of the video by using and e Clicking and holding the slider on the time bar and dragging it to move the video forwards or backwards e Clicking the time bar moves the video image to that specific location JTS Note After the Pause button is pressed the mouse wheel can be used to scroll the video forward or backward To go to a specific frame of the video 1 Select numbers of the time indications 2 Type the desired time unit in the format HH MM SS 3 Press ENTER The video automatically progresses to the exact video image of the time specified Dual Head View PillCam ESO and PillCam COLON capsules have two video heads and by default two images are displayed one for each head of the capsule Note that two images displayed thus side by side is not DualView the two side by side images are from different video heads The capsule icon as shown below is both the control and the indicator f
183. oblem power blinking but cradle is not in 2 Reconnect cradle to mains discharge mode power 3 If problem persists contact Customer Support PillCam recorder DR2 cannot Hardware malfunction Contact Customer Support be placed in cradle PillCam Recorder DR3 Problem Action Capsule icon blinking red Interference Recorder malfunction Capsule icon blinking white Capsule not paired yet Refer to PillCam Recorder DR3 SD card errors Wrong or damaged SD LEDs Indications card Sensor connection Wrong or damaged sensor PillCam recorder freezes Possible static Perform Hard Reset on the PillCam electricity discharge recorder Contact Customer Support Cannot initialize PillCam Wrong recorder bar is Select correct recorder bar recorder DR3 selected Sensor Belt 171 PillCam Capsule Endoscopy Problem No communication between the PillCam recorder and RAPID software Action Recorder not inserted e Clean the contacts with alcohol PillCam Recorder DR2 172 Problem Cannot initialize PillCam recorder DR2 Cannot create video Capsule LED right does not blink in blue when capsule is activated LED is orange Capsule LED right blinks in orange once every five seconds when more than six hours have passed since ingestion Capsule LED right blinks in orange once every five seconds when less than six hours have passed since ingestion PillCam recorder DR2 shuts down during the procedure Cancelling Dat
184. ocedures e Click Yes and follow the instructions on the screen When the update is done remove the PillCam recorder from its cradle and reinsert it e To ignore the update click No You may continue the check in and perform the update later e Selecting the checkbox Do not ask me again will disable further updates to this specific recorder This option is available only if you are logged in as the administrator EN This recorder requires a software update Do you want to update the A recorder software version Don t show this message again The Patient Check In wizard opens Patient Check in This process prepares your recorder for the next Welcome patient Initializing the recorder will overwrite previous O Procedure data information O initialization IMAGING 5 Click Next to continue 26 Performing Patient Check in Preparing for PillCam Capsule Endoscopy The first Patient Check In window appears Procedure Information Dalven Welcome Kateri Procedure information 8990763 lt Femal initiaiization Gender ami Birth Date z 11 Apr 61 bd Procedure Date 24 May 12 gt Capsule ID Capsule Type Mandatory field Capsule type mustmatch capsule to be used 6 Enter patient data by importing from HIS Hospital Information System or by typing in manually HIS Import If you are working in a HIS enabled networked environment you can impor
185. of the PillCam recorder for at least 3 seconds c Follow the corresponding post capsule ingestion instruction on the supplied printed out d Follow instructions only when prompted by the PillCam recorder and only the instruction that matches the displayed number even if the PillCam recorder skips a number General Patient Guidelines During the Procedure 23 PillCam Capsule Endoscopy e The PillCam recorder DR3 displays the End of Procedure screen fe beeps and vibrates when the procedure is over and shuts down automatically at least five minutes later Avoid any physical activity that involves sweating bending or stooping Remain active Do not sleep Use the bathroom as often as needed do not suppress the urge The use of wet wipes and cream to protect the skin is recommended Avoid any source of powerful electromagnetic field such as an MRI device DR3 only Do not remove the PillCam recorder until the capsule 1s excreted or the End of Procedure instruction appears on the PillCam recorder DR3 only If the capsule icon at the top of the screen is red move to a different location until the capsule icon is black and the LED has resumed blinking DR2 only If the LED of the PillCam recorder stops blinking blue before the end of the procedure contact the medical staff The end of the procedure for a PillCam recorder DR3 is when the End Of Procedure instruction is alerted and displayed on the recorder screen For a PillCam
186. om of the Displayed columns list To change the name of your column select it and click Rename To remove the column from the Study Manager select it and click Delete 10 In the Study Manager the User Column will require manual input of the data To enter data in your column first select the relevant study Click in the cell of the study in your column Type in your text in the separate window that opens When you are done click OK In the example below a user column named Reviewed By was created Manually entered data Reviewed By column Study Manager Last First z Name Name ID Gender Type Date Physician Physician ICD Code Created Findings Reports wenger Dem ss500766 mde COLON arma orton e e e frena eso wor e v COMETA CO UC CEA AS A ww a es JU JE ee ERE ae Capsule Procedure Refering Ordering Video See Revidwed y 07 Jan 09 Dr Bain Loading studies successful ALG Note Created user columns can be available to other users Make sure the users have the same path defined in Shared data directory in the Settings Study Manager CAPI lata Applicati Give mglStudy Sota re DatalGreen Imaging Study Browse M Display capsule sub type Pal Open findings automatically Loading a Study with the Study Manager Reviewing and Interpreting RAPID Videos Using the Study Manager Open You can open videos and other files in the study from the Study Manager To ope
187. ome screen All future mention of Home screen such as From the Home screen click the Tools button refers to the screen described above PillCam Capsule Endoscopy System Components Welcome to PillCam Capsule Endoscopy 1 Patient Check in opens the patient check in wizard to enter information about the patient and the procedure and to initialize the PillCam recorder with this data There are a series of screens that walk you through the check in process see Performing Patient Check in on page 24 2 Recorder Download opens a screen to download data from a PillCam recorder see PillCam Recorder Download on page 67 and to create a RAPID video from the data 3 View Study clicking this button opens a menu that provides access to e Study Manager allows easy access to all studies The Study Manager allows you to open search sort delete and export studies see Using the Study Manager on page 83 e Open Video open a saved RAPID video and findings if available by opening a windows screen that enables you to locate the RAPID video e Recent Videos displays recently viewed RAPID videos that can be selected and opened Open Video Recent Videos 4 Tools clicking this button opens a menu that provides access to e Regimen Manager opens a software tool for creating or modifying capsule ingestion regimen instructions for the patient see Regimen Manager on page 148 e Settings enables user configuration of RAPID settings see
188. on of the sensor array Wrong sensor chosen in the check in process Atlas installation incomplete or incorrect COLON2 video compiled in RAPID v 8 cannot be viewed using RAPID v 7 Saving and Opening Video Problem Cannot locate video Cannot locate findings Cause Video was not saved in E Videos Video was not created Incorrect patient s name Findings were not saved under patient s folder Findings were saved with the wrong name Appendix A4 Troubleshooting Action e Contact Customer Support e Send video on CD DVD e Inform capsule lot e Do not use the same PillCam recorder e Save the raw data locally on your computer e Send video on CD DVD e Save the raw data locally on your computer e Contact Customer Support e Do not use the sensor e Contact Customer Support e Reinstall Atlas e Save the raw data locally on your computer e Contact Customer Support Download and use RAPID Reader v 8 to view video Action e Search for video in RAPID Work Directories or in Study Manager video creation e Contact Customer Support e Refer to Saving Findings File in Saving Your Findings on page 115 e Contact Customer Support 169 Given Imaging PillCam Capsule Endoscopy Problem Cause Action Study cannot be selected Changing an archive location Modify the archive location in Study Manager that appears in the Study manually Manager dialog the archive remains on the archives list bu
189. on the screen of the PillCam recorder DR3 z MU 12 35 AFR E Jonn smitn LJ 12345 El COLONZ a 1234567 PillCam Recorder DR3 45 PillCam Capsule Endoscopy Charging Charge the PillCam recorder DR3 by placing it in the cradle The cradle charges the PillCam recorder DR3 and also connects the it to the PC for performing patient check in and creating videos There are two LEDs at the base of the cradle e The top LED is orange when the PillCam recorder DR3 is in the cradle e The bottom LED is orange while charging and green when the PillCam recorder is fully charged There is a power connector on the back panel of the cradle t AA power connector The PillCam recorder 1s ready for operation when e its battery is charged e it has been removed from the cradle e itis connected to the sensor belt or sensor array Warning MN Never connect the PillCam recorder to the sensor array or the sensor belt while the PillCam recorder is in the cradle Do not use the DR3 cradle for any USB devices except the PillCam recorder DR3 Controls Main Display The main display of the PillCam recorder DR3 displays the relevant information during the different phases of the capsule endoscopy procedure 46 PillCam Recorder DR3 Know Your PillCam Recorder After Initialization after check in and before pairing with the capsule the recorder display shows the relevant procedure information data as follows Battery c
190. onos 122 Atlas Image EX DOM rei cigs Gates o a 123 LEWIS SC ONC caia 123 Genetatingia REDO iii ia iaa 126 image Data Buttons Cro Pus e Ed 127 Appendix A1 Installing RAPID Software oocooccoccoccoccoccocconconconcnaronnnaconnnanonnnanennrnnrnnnnano 131 Setup Requirements ada 131 RAPID InstallatoON sica diia aa 131 Main Endoscopy System Components c 0cocccocncocononoconoconoconanonanonanonanonanonarennrnnnrennrenarenarnnnns 132 Connecting the Components unitaria da 132 Connecting the PillCam Recorder Cradle cccccesceeeeeeeeseeeseeeeeeeeeeeeeeeeeneseneeeeeeseesenaes 132 Starting RAPID Tor the First TIME iii A vent 133 Appendix A2 Configuring RAPID Software cooccoccoccoccoccocconconcncnocccanonnnanonnnnncnncnarnarnnnns 135 Single or Multi user SEUNG inca iaa 135 RAPID Workstation Configuration ooccoocccocncocococncocnnncnoncnoncnnnnnnnnnnnnnnnnnnnnnnnnnnannnnninanoss 135 RAPID SENOS ida a AA A dd 136 General Tab usina ina 137 VideO TaD add 139 A A E T 141 Checkin Mara 145 RES Ue TaD aasan a a a a eect ore sae 146 REJIMEN Managua 148 Using the Regimen Managet cccceccsecceccececeeceeeceeceeeceecusecuecaseceeeaueseeseesseeeseesanenes 148 Pre Ingestion Patient Instructions oooccocconcconionncononcnoononnconnonnnnononanonncnanonnnnnncnnnnos 149 Post Ingestion Patient InstructiONS ccoccocccocnnoccccnconcnconononnnonconancnronancnronanonnnnanencnnos 151 To Pr
191. ons on page 179 For indications and contraindications see Indications Contraindications Warnings Cautions on page 3 Caution The PillCam capsule transmits at a specific frequency of 434 1MHz ina bandwidth of 10MHz Occasionally interference from external devices transmitting in the same bandwidth may occur that may interrupt or limit the effective performance of the capsule transmission The following possible cases could occur e Car or house alarm These operate with momentary transmissions Depending on the proximity of the car or house alarm transmitter to the ingested capsule there could be a momentary interference that should not damage the capsule video o _ e Police Fire stations radio equipment These may operate with more extended transmission durations Depending on the proximity of the car or house alarm transmitter to the ingested capsule this could cause longer duration interference possibly causing gaps in the capsule video 14 PillCam Capsule Endoscopy System Components Welcome to PillCam Capsule Endoscopy Handling the PillCam Capsule PillCam capsules are packaged using a controlled process that ensures the capsule is activated only when needed Each PillCam capsule 1s packed in a separate box with an embedded magnet that prevents it from activating when it is handled in the box prior to ingestion To avoid accidental activation blinking of the capsule while in its box please observe the following
192. or the dual head video display mode The icon consists of three buttons left green 1f active right yellow if active and the middle activates both displays green and yellow Capsule lean Display Default view for COLON and ESO videos images of both heads are displayed Click either the far left side or the far right of the icon to view one single video View only the images from one head Click the other side to view the video from the other head Click the middle of the icon to return to viewing both videos When typing thumbnail comments in PillCam ESO and PillCam COLON videos the comments appear green for thumbnails captured from the left represented capsule video head and yellow for thumbnails captured from the right represented capsule video head Using RAPID to View a Video 101 PillCam Capsule Endoscopy 102 SBI View PD The Suspected Blood Indicator SBI feature automatically marks images suspected of containing blood and provides the ability to review them in sequence SBI image locations are marked on the Color Bar In the SBI mode RAPID shows the SBI marked images The video control buttons turn red and you can play the SBI images only back and forth by the controls SBI images are also included in the Quick View This viewing mode feature is available only e After the first landmark is entered for the first duodenal image or any later landmark e Ifsuspected images are found e The RAPID video is a Pil
193. orarily but displays the ribbon tab To temporarily show the ribbon click once on the desired tab Clicking anywhere on the screen will hide the ribbon again To restore the ribbon click on the File View or Report tabs or right click the Quick Access Toolbar and uncheck Minimize the Ribbon Optionally click the minimize button a on the top right of part of the ribbon and click 1t again to restore Overview of the RAPID Interface File View Reviewing and Interpreting RAPID Videos The File menu located on the left View tab contains several commands that enable to open a video or findings save a video connect to the Study Manager or connect to the RAPID Help The table below displays the File menu commands You can click on the command or if available a secondary command appears when hovering the mouse over a command Button Open Save b jl Close EM Study Manager Recent Videos a i K Tools P Overview of the RAPID Interface Menu command Secondary commands Clicking the Open button Open Video from selected folder launches the Windows screen to browse and open a video Optionally hover Open Findings related to the over the button to display a currently open study secondary commands Click to save video or o hover over the button to la Save Findings display secondary commands la Save Findings As E Save Video As Save de Identified Video As Close video or findings gt C
194. order to RAPID The PillCam recorder must be connected to RAPID during patient check in The check in process allows entering patient and procedure data for the procedure and saves the correct patient and procedure information to the PillCam recorder The process is explained in detail in this section The PillCam recorder connects to the RAPID workstation or Personal Computer PC via the cradle Caution Y Connection of the PillCam recorder to the RAPID software for patient check in video download and recorder upgrade must be done using the cradle 1 Make sure RAPID is On 2 Make sure the PillCam recorder 1s firmly inserted into the cradle 20 Preparing the Required Equipment Preparing for PillCam Capsule Endoscopy 3 Click Patient Check in B on the RAPID Home screen RAPID citer Patient Check in Recorder Download E View Study Ca a Y A GlyEN IMAGING ria Note e RAPID displays DR3 battery warning if it exceeds 400 cycles Contact customer service for replacement e Do not remove the PillCam recorder from its cradle before the end of the check in process 4 Inthe Procedures screen select the Recorders tab 5 Click the Recorder bar to connect the function buttons to the PillCam recorder Button Action Identifies the PillCam recorder for the selected recorder bar When you click this button all the LEDs on the associated PillCam recorder and cradle blink Prepares the Pi
195. ot ingest the capsule an acceptable alternative is to sedate the patient and place the capsule into the duodenum using a device such as an endoscopic basket loaded onto an upper ente roscope e Placement into the duodenum is recommended to prevent the patient from vomiting the capsule e Pediatric patients who are physiologically mature enough to ingest capsules can be taught by practicing with candy starting with very small candies and gradually introducing larger candy pieces until the patients demonstrate the ability to swallow an object the size and shape of the PillCam SB capsule PillCam ESO The PillCam ESO capsule is contraindicated for use under the following conditions e In patients with known or suspected gastrointestinal obstruction strictures or fistulas based on the clinical picture or preprocedure testing and profile e In patients with cardiac pacemakers or other implanted electromedical devices e In patients with dysphagia or other swallowing disorders JDE Note This device is not meant to replace upper endoscopy PillCam COLON The PillCam COLON capsule is contraindicated for use under the following conditions e In patients with known or suspected gastrointestinal obstruction strictures or fistulas based on the clinical picture or pre procedure testing and profile e In patients with cardiac pacemakers or other implanted electromedical devices e In patients with dysphagia or other swallowing disorders
196. ote save the findings frequently to avoid accidental loss of data To save findings in new location 1 Select File gt Save gt Save Findings As The Save Findings As screen appears Select a location for saving e If you intend saving to a disc insert a formatted writable disc into the appropriate drive and select 1t from the screen e Ifyou intend saving on a USB device plug in the USB device and select the USB device e The default location is the RAPID folder of the currently displayed video Click Save The findings file is saved The name of the associated RAPID directory the associated RAPID video file and the findings are saved To save findings to the last saved findings file Click the Ej button in the Quick Launch toolbar located at the top of the RAPID screen or click Save Findings from the File menu The findings file is saved to the same location and under the same name Opening a Findings File JTS Note You may load only a findings file associated with the currently displayed video If you attempt to load a findings file that is not associated with the loaded RAPID video an error message appears notifying you of the mismatch If you load another findings file associated with the same video the open findings file closes A message appears asking you to save the open findings file before closing it To open a findings file 1 Select File gt Open and then select Open Findings If a findings fi
197. ovides an approximate measure of degree and extent of mucosal damage based on direct visual imaging of the small intestine not provided by current methodologies The index is based on quantitative and qualitative descriptors relating to three endoscopic variables villous edema ulceration and stenosis Combined with other clinical parameters Symptoms patient and family history previous diagnostic tests lab values the score could provide a threshold for differential diagnosis and be used to monitor the progress of treatment e An automated scoring system provides greater standardization of disease activity assessment e Provides an additional point of evaluation to assist in determining appropriate patient management e The Lewis Score facilitates communication and standardization for assessing disease states before during and after treatment e Monitoring therapy effectiveness with a standardized score has clinical value Lewis Score 123 PillCam Capsule Endoscopy When clicking the Lewis Score button a scoring index is displayed and the currently selected thumbnail is shown on the right side Lewis score Close Lewis score screen and Selected thumbnail return to the Report screen OS SS Se ee i i _ gt gt c BIBS e oe E RAPID PillCamSB Physician Dr Schnaider _CRT ID 194 1 07 Jan 09 a ee Template Imal e M L amp Select All Thumbnails RP ri R E p 5 Fy Save Video Segment 5 AA ir
198. ows the closest approximations of words starting with the same letters c If the matching word exists the cursor highlights the word Press SHIFT ENTER to enter the complete word without further typing or double click 1t in the GI Dictionary d All keyboard commands for the user dictionary Using RAPID to View a Video 105 PillCam Capsule Endoscopy Shift Move the selection cursor inside the dictionary Up Arrow Down Arrow up down Shift Enter Inserts the current selected dictionary phrase to the text box Control R Shift Align the text to right side Control L Shift Align the text to the left side ESC Temporarily close the GI Dictionary e Spell checker if the spell checker is activated a red wavy line appears below any word not recognized by RAPID To select one of the suggested corrections right click and select the desired option ALG Note If you write more than 256 characters in the text box of a thumbnail comment the final printout of the thumbnail comment may be split between two pages Any thumbnail after that will start on a new page leaving the space after the split comment blank To enable or disable the GI Dictionary or the Spell Checker 1 From the Home screen select Tools gt Settings 2 On the General tab under the Regional Settings select the check box next to the feature Regional Settings Language English ki Enable spell check Enable GI Dictionary Measurement units M
199. plate must be selected Electronic Signature An electronic signature is a way to allow authorized personnel to approve and validate a document without having to physically print 1t out and sign 1t manually With this feature you may produce a signed capsule endoscopy report with the signing physician s name appearing in the signature field where the electronic signature feature 1s the only way to achieve this thus signifying signature of the document Electronic signatures are widely accepted as legally valid By default the electronic signature feature 1s disabled To activate use of electronic signature in Settings 1 From the Home screen select Tools gt Settings The Settings screen appears 2 Select the Report tab 3 Inthe Report Template section select Request electronic signature and click Apply or OK Report Templates Configure the available templates for report generation select Report template file name Image M Localization Progress Indicator Image M Fi Image M Localization Progress Indicator Image M fr Image M Localization Progress Indicator Image MM L al Image M Localization Progress Indicator Image M j Request electronic signature Use of the Electronic Signature Once the electronic signature is activated the signature will be displayed when creating or printing a report The signature will appear as electronically signed by your first and last name as it
200. ppears on either side of the thumbnail section Click and hold either of the arrows to scroll left or right When you hover with your cursor in the thumbnail section a scrollbar appears on the bottom allowing you to drag the bar to sideways to scroll through the thumbnails Using your mouse click and hold on the thumbnail section and drag the thumbnails to either side to scroll Thumbnails can also be annotated saved exported as images deleted or selected for inclusion in the capsule endoscopy report Thumbnail Status The thumbnails are displayed on the bottom of the View screen Visual appearance designates different statuses Thumbnail Description This is a thumbnail without any visual effects 02 48 19 Dark blue background means that the thumbnail is selected so operations can be performed on it For multiple selections hold down the CTRL button on the keyboard and click the desired thumbnails with the mouse For multiple selection of consecutive thumbnails Hold down the SHIFT key and select the first and last desired thumbnail All available actions displayed by right clicking on a thumbnail will operate on all selected thumbnails 00 37 23 The external blue border means that the thumbnail is selected for inclusion in the report The internal border means that this thumbnail is the currently displayed video image 015128 Using RAPID to View a Video Reviewing and Interpreting RAPID Videos Thumbnai
201. procedure video Images can be saved in JPEG format for viewing later Additionally video clips centered on selected images can be generated for the patient to be viewed in Windows Media Player Generating a Report 127 PillCam Capsule Endoscopy 128 Button c Save Clips Images Function Create an image from a thumbnail or a video clip from a selection of thumbnails Click the Save Clips Images button and select from the different options in the drop down list and then choose the directory to save the file s Images Only Video Clips Only Video Clips and Images Create Video Clip Creates a jpeg s of the selected thumbnail s and saves to a folder Creates mpeg video clip s surrounding the selected thumbnail created from 50 before and 50 after the selected thumbnail Video clips can be viewed in Windows Media Player The number of images used in creating a video clip from a selected thumbnail is determined in Image Data settings Click the dialog launcher on the bottom right of the Image Data button group Em Save Video Segment qH Save Joined Segment By Compare Thumbnails Save Clips Images z Image Data This will launch the Image Data screen Video Clip Length The default length of clips is 100 images Change and select the number of desired images for each thumbnail 50 100 or 150 and click OK If upgrading from RAPID v7 and previous setting was 200 images for
202. r Location Guide ESO SB or COLON e Adhesive sleeves to hold each one of the sensors securely in place e Razor and disinfectant not supplied to shave the area of the sensors on the abdomen Fitting Equipment on the Patient 33 PillCam Capsule Endoscopy 34 ALG Note sensor arrays must be applied directly to smooth skin Anything that comes between the patient s skin and the sensors including hair or air and any changes in the sensors arrangement may interfere with the quality of the data Warning Do not use the sensor array if it is torn or damaged To attach the sensor array 1 7 DR3 only with the patient standing and exposing the thorax and abdominal area place the sensor array loop on the left shoulder If the loop is too long gather and fasten the surplus in the fastener Ask the patient to lie down Use the appropriate Sensor Location Guide to identify the location of each sensor on the patient s body and mark it with a dot The sensor array sleeves should be applied to hairless skin If needed wipe the patient s skin with disinfectant and shave the areas where sensors are to be applied With the sensor array connector at the patient s side lay the prepared sensor array on the patient s abdomen and match the letters and colors on each sensor wire to the letters and colors on the Sensor Location Guide To attach each sensor remove the protective backing from its adhesive sleeve AL Note Since th
203. re event of a malfunction In order to enable this feature you must first enter the email address for your regional Given Imaging Customer Support To enter Customer Support details 1 From the Home screen select Tools gt Settings This opens the Settings screen 2 Select the Other tab 3 Under Customer Support click the Email list and select your regional customer support center If it is not listed you can type in the email address manually Customer Support Email supporteu givenimaging com Iv SA o SA Address To extract and send RAPID log files In the event that you are requested to send the log files to Given Imaging Customer Support the steps below should be followed 1 From the Home screen click Help gt Customer Support gt Collect Analysis Files The following screen appears Customer Support Select the analysis files for collection Logs Fa System logs Y Application logs Vie os O Bemwe J General comments i Cancel A od 2 Click the General Video Recorder Capsule amp Sensor tabs and enter the information in the editable fields If there is a video that needs to be sent as well click the Browse button in Video logs and navigate to the video 3 Click the Email button to send the data to Given Imaging Customer Support RAPID Settings 147 PillCam Capsule Endoscopy Regimen Manager 148 The Regimen Manager is a RAPID software too
204. recorder DR2 the end of procedure is when the capsule LED of the PillCam recorder stops blinking blue no transmissions from the capsule are received and more than 8 hours for a PillCam SB capsule or a PillCam COLON 2 capsule and more than 30 minutes for a PillCam ESO capsule passed since the ingestion of the capsule The end of a procedure may also be declared by the medical staff after proper consultation 1f the blinking stopped before the above specified times At the end of the procedure remove the PillCam recorder and sensors If you need assistance or were instructed to do so return to the clinic to have this done Contact the medical staff in case of any unexpected event or doubt Performing Patient Check in 24 Patient check in 1s the process of entering patient and procedure data into the PillCam recorder This information becomes part of the data in the RAPID video and capsule endoscopy report During this process old data from previous procedures 1s cleared and the new patient and regimen information is saved to the PillCam recorder For COLON 2 procedures patient check in also programs the PillCam recorder to provide post ingestion patient alerts It also allows you to print out the selected post ingestion instructions for the patient Make sure that the RAPID workstation or PC 1s connected to a printer for printing the post ingestion patient instructions LN Note Make sure that an approved post ingestion regimen is avail
205. recorder models are provided with a cradle for charging and connecting to a PC and a pouch to allow the patient to wear the PillCam recorder during the procedure A Note For full technical specifications about the PillCam recorders their cradles see System Specifications on page 179 Functions Initialization Initialization 1s a mandatory operation before the procedure With the PillCam recorder connected to the RAPID the patient and procedure data are uploaded to the PillCam recorder so that the ensuing study and procedure data are personalized The initialization of the PillCam recorder 1s performed through the RAPID check in process see Performing Patient Check in on page 24 while the PillCam recorder 1s connected to the RAPID through its cradle The PillCam recorder is a passive element in this process and no control or operation on it is required Pairing Pairing is performed before PillCam capsule ingestion the capsule and PillCam recorder are made to connect so the PillCam recorder is tuned to the transmissions only from the paired capsule There are several ways of pairing a capsule to the PillCam recorder depending on the recorder type and on user preference In some of these ways the user needs to interact with the recorder through its display and its control buttons Pairing for PillCam recorder DR2 may be performed only through the check in see Performing Patient Check in on page 24 Pairing for PillCam recorder DR3 may
206. rectory and click Next The following screen appears 3 Inthe following screen click the Directory button to launch the Export Directory screen 1 Backup and Restore Offline Studies x GIyEN Export file path Sido Seen Send or Directory Back Next Cancel 4 Click the Browse button and navigate to the location to export the backup a Export directory E ai e e Directory CAUsersiDefaultWVideos Browse File name CMDB_20120627 Microsoft Access accdb y Save Cancel 5 Enter the file name of the backup and click Save 6 When the process is complete a message appears that it was completed successfully Click OK Additional Settings 157 PillCam Capsule Endoscopy To import backup Offline Studies 1 In order to restore Study Manager Offline Studies click the Windows Start button gt Given Imaging gt Backup Restore Offline Studies The following screen appears E Backup and Restore Offline Studies Lo o E GI TEN Pagers e wren of 2 Select action Export directory E Import directory Back Menct Cancel 2 Select Import Directory and click Next 3 In the following screen click the Directory button to launch the Import Directory screen 4 Navigate to the database file with Microsoft Access acedb file extension and click the Open button to load the offline studies to the RAPID Study Manager Import directory e A o a A ee
207. reen Open a selected study by double clicking it or click once and then click the Open button The Study Manager provides a list of the videos available for viewing The Study Manager organizes the studies in a way that enables easy access and management of studies sorting and searching by different criteria such as patient name and procedure dates Refer to Using the Study Manager on page 83 for more information To view a video you can also click the File menu on the RAPID interface and browse for your study in the file system Reading a Capsule Endoscopy Video Before loading a RAPID Capsule Endoscopy video to the RAPID software it 1s important to review the patient history prior to reading the video in order to e Consider all possible indications as per the patient history e Prepare for identification of relevant pathology as per the possible indications identified To read PillCam studies efficiently the reading process 1s broken into 3 components e Preview scan the capsule endoscopy video using QuickView mode to establish a preliminary interpretation This can be followed by a Complementary QuickView scan to perform a complete review of the video You may also augment your preview by previewing in SBI mode to quickly scan the bleeding suspicious images e Review Review the complete capsule endoscopy video in normal viewing mode e Report Complete a Patient Report that summarized the interpretation of the study Refer to Creating a
208. rint the Patient Instructions on page 153 e When securing the sensor belt make sure the fabric of the patient s shirt is not folded beneath the front portion of the sensor belt e Make sure nothing other than a single thin layer of fabric is allowed to come between the sensor belt and the abdomen e In order to avoid pulling the sensor belt out of position do not attach or anchor anything to the sensor belt e Be sure that the PillCam recorder is worn over the sensor belt and that the PillCam recorder pouch is not attached to the PillCam sensor belt e Another layer of clothing may be worn over the sensor belt as long as the sensor belt connecting wire can be attached to the PillCam recorder Fitting Equipment on the Patient 41 PillCam Capsule Endoscopy 42 Fitting Equipment on the Patient Chapter 5 Know Your PillCam Recorder Preparing the PillCam Recorder PillCam recorder is used to receive and store the captured images from the PillCam capsule during the capsule endoscopy procedure for subsequent download to the RAPID The video created from the downloaded data can then be reviewed by the physician There are two PillCam recorder models DR3 and DR2 The DR3 model is the newest model and works with all types of PillCam capsules and provides advanced functions of real time viewing during the procedure The DR2 model is the previous model and it works with all types of PillCam capsules in a fixed frame rate mode Both
209. s a findings file created for this procedure e Reports Study includes a report of the procedure Study Options When right clicking on a selected study in the Study Manager the following options are avallable e Manage Columns enables the adding deleting and creating of Study Manager columns see Managing Columns on page 81 e Update Patient Details changes or updates all the patient and procedure information even after a video 1s created Click Save when finished e Print Regimen opens a print preview layout of the Regimen for this procedure see Print Layout of the Post Capsule Ingestion Instructions on page 154 e Open Video Only opens the procedure video without the findings If any findings are added during review when trying to save you will be prompted to overwrite any existing findings file see Open on page 83 e Export Table Information saves the selected archive data to a static line and column format Excel file displaying all the studies for that archive e Show All Search Results displays the screen of results of the search performed see Search Function on page 79 Understanding the Status Bar A status bar at the bottom of the screen shows the number of studies displayed the number of studies selected the amount of free space on the selected archive and loading status of the studies Loading studies successful Loading a Study with the Study Manager Reviewing and Interpreting RAPID Videos Action B
210. s affected by absorption and reflection from structures objects and people Guidance and Manufacturer s Declarations 199 PillCam Capsule Endoscopy PillCam Recorder DR3 Guidance and manufacturer s declaration electromagnetic emissions The PillCam recorder DR3 is intended for use in the electromagnetic environment specified below The customer or the user of the PillCam recorder DR3 should assure that it is used in such an environment RF emissions CISPR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions N A IEC 61000 3 3 RF emissions The PillCam recorder DR3 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The Pillcam recorder DR3 is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Guidance and manufacturer s declaration electromagnetic immunity for all equipment and systems The PillCam recorder DR3 is intended for use in the electromagnetic environment specified below The customer or the user of the PillCam recorder DR3 should assure that it is used in such an environment Electrostatic discharge ESD 6 kV contact 8 kV air IEC 61000 4 2 Electrical fast 2 KV Tor Power supply lines transient
211. s your PillCam capsule its ID code is displayed on the screen alone or in addition to IDs from other capsules Bi nas 02 6J 12345 This mark indicates that this capsule ID will be selected when pressing the middle navigation button 3 Ifonly one capsule ID appears on the PillCam recorder screen check the ID Code shown in the PillCam recorder screen against the ID code displayed on the PillCam capsule package If the codes match press the middle navigation button above which e appears on the screen 4 Ifmore than one capsule ID appears on the PillCam recorder screen use the navigation buttons located below Tor y icons on the screen to scroll to your capsule ID and press the middle navigation button located below icon on the screen to designate and initiate pairing of your capsule with the PillCam recorder The Pairing success icon 4 will appear in the top right corner of the screen PillCam Recorder Capsule Pairing DR3 only 59 PillCam Capsule Endoscopy aa AS Note e IfaPillCam COLON 2 capsule blinks slower than 1 blink per second during the pairing procedure return it to its box and start over e If at any time before ingestion the capsule does not blink for at least 20 seconds do not use this capsule Instead use a different capsule and repeat the pairing procedure Note If after designating the capsule e the patient does not ingest it within ten minutes or e you suspect that the cap
212. sage appears xi Low signal detected during this study Localization is not enabled See User Manual A low signal detected during the examination may be due to e Improper use of the sensor array sensor belt e A defective sensor array sensor belt e A PillCam recorder malfunction If this message is displayed Contact Customer Support Click OK to close the message Error Messages 173 PillCam Capsule Endoscopy 174 Low Signal System Labeling Appendix AS Technical Description The following table lists the labels attached to various components of the PillCam Capsule Endoscopy System Labeling On ae A elie 4 O am UN O a E gt ra Given Imaging Explanation The PillCam capsule should not be stored and used near any powerful magnetic fields such as the one created by an MRI The PillCam capsule is intended for single use only Attention Consult the documentation provided with the PillCam Capsule Endoscopy System Temperature limits Type BF equipment FCC compliance CE mark C Tick mark CSA mark Expiration date Recycle Lot number Indoor use only C 5 gt lt 00 rH REGA Non ionizing radiation RoHs Capsule ID Ingress protection Do not Iron Latex free Machine wash warm Do not tumble dry Do not dry clean Do not use bleach 175 PillCam Capsule Endoscopy Capsule Labeling Each box has a label at the botto
213. such as Acknowledge will yield an audio beep feedback only at the end of defined duration for button pressing i e at the end of 3 seconds e A momentary press on a button that is designed to activate a function only after continued pressing 1 e Acknowledge will not yield any audio or visual feedback In case the volume is set off no audio indications should play Battery and Capsule Icons The battery icon on the left side of the status line at the top of the display indicates the status of the battery in 10 increments These icons appear in the top status line of the PillCam recorder DR3 screen Icon Battery Status Icon Capsule Reception Status Battery fully charged Signal weak recording with Di Y noise Battery charge level at 10 Signal strong recording with intervals 91 noise Battery empty PillCam a Signal weak but recording OK recorder shuts down DON Battery charging Signal strong and recording 81 OK PillCam Recorder DR3 49 PillCam Capsule Endoscopy 50 PillCam Recorder DR3 LEDs The status indications of the LED indicators on the top of the PillCam recorder DR3 for the most common PillCam recorder events are as follows LEDs Constant on in yellow orange D Blinking in white Blinking in blue at capsule frame rate Blinks in yellow orange every 5 seconds Constant on in green DD Constant on in white Blinking in green Constant on in red Bli
214. sule Endoscopy 16 PillCam sensor array The sensors of the sensor array are attached to the patient s skin The locations depend on the procedure type Each sensor 1s built of a flexible printed circuit board PCB and is attached with a disposable medical adhesive sleeve The PillCam sensor array and belt are connected to the PillCam recorder by a flexible cable NS Note The PillCam Capsule Endoscopy System does not contain any natural rubber latex components RAPID for PillCam Software Version v8 of the RAPID for PillCam software RAPID v8 supports the procedure by providing access to the different steps in PillCam capsule endoscopy Access to the different steps in the procedure is provided by using the Home screen The Home Screen After starting the RAPID v8 software the Home screen appears The Home screen is the main screen that provides access to all phases of the PillCam capsule endoscopy procedure The Home screen enables the following functions e Patient Check In admitting the patient and initializing PillCam recorder e Recorder Download creating the RAPID video e View Study viewing videos and allowing interpretation as well as generating capsule endoscopy report see Reviewing and Interpreting RAPID Videos on page 75 RAPID sica y Patient Check in 1 E Recorder Download 2 E View Study 3 Cac 4 aD aD 5 6 GIyEN ALG Note i Certain key functions described in this manual are accessed from the H
215. sule is defective Return the capsule into its box When you close the lid if the capsule stops blinking it is deactivated If the capsule continues blinking rotate it around its axis without removing it from its place holder in the box until it stops blinking when you close the lid To use this capsule later if it is not defective you must repeat the pairing process Capsule Ingestion Capsule ingestion 1s the process of having the patient swallow the PillCam capsule 60 A DR2 only Multiple Procedures When performing more than one PillCam capsule endoscopy procedure in the same vicinity with PillCam recorder DR2 follow these guidelines to prevent signal interference with other procedures e After patient check in keep the PillCam recorder in the cradle without sensors attached until capsule ingestion procedure begins Return it to the cradle when the procedure is complete e Ifthe blue PillCam recorder LED is blinking before you open the box of the capsule you intend to use repeat check in with the PillCam recorder see Performing Patient Check in on page 24 e Perform only one capsule ingestion at a time with no other active PillCam recorder or capsules present in the room e Attach sensors to the PillCam recorder immediately prior to the ingestion after sensors are properly positioned on the patient e Do not permit patients wearing PillCam recorders to stay directly next to other patients with ingested capsules
216. t the patient check in data to automatically complete the check in fields a Click Import The Import Patient Data screen appears The available data for patients not yet checked in appears on the screen sorted by planned Procedure Date You can sort the studies by any of the column headings in either ascending or descending order AAN ia b To select a patient select the relevant line and click OK This automatically adds check in data into the appropriate fields in RAPID Once imported the patient data is removed from the Available for check in list and appears in the Already imported list In the list next to Display at the top of the screen you can select which patient list you wish to see Available for check in or Already imported To delete a patient from the Already imported list select the relevant line and click Delete Once you click OK the first check in screen appears again with all available information already entered You may need to complete additional mandatory or optional procedure information such as capsule ID not auto populated from the HIS see the RAPID 8 IT Guide When all necessary data entry is completed you may proceed to the Procedure Performing Patient Check in 27 PillCam Capsule Endoscopy info confirmation screen by clicking the Next or Finish buttons or by changing any of the information fields Manual Data Entry You can enter patient information manually Enter the patient s
217. t its study cannot be selected Cannot open a video Archive privileges set with no Allow Read and Write access to from an archive in Study access to read or write the archive folder Manager and an error message requests user to click the refresh button Printer Problem Action Cannot print report Printer is turned off Turn printer on Printer is not set as default Set printer to Default Printer printer Printer has a malfunction Contact Customer Support CD DVD Problem Action Cannot burn CD DVD CD DVD is not blank or compatible with CD DVD Contact Customer Support ROM Wrong burning procedure Cannot eject CD DVD A video on the disc is open Close the video and retry sensor Array Problem Action Connector is damaged Sensor is torn from its wire Insulation of the sensor wire is damaged e Mishandling End of Life Contact Customer Support 170 Printer Troubleshooting Sensor Belt Problem Action Connector is damaged e Mishandling the sensor Insulation of the sensor wire belt is damaged e End of Life e Stop using this sensor e Contact Customer Support Capsule Problem Action DOA Dead On Arrival Capsule failure 1 Send capsule to Given Imaging Ltd 2 Open another capsule 3 If second capsule from 10 pak is DOA contact Customer Support Cradle Problem Action Cradle LEDs turn red All LEDs are flashing red 1 Disconnect cradle for mains Cradle orange LED is Hardware Software pr
218. t mid inguinal region DOC 1817 01 COLON Sensor Location Guide DR3 EN Sensor Label Sensor Color A Black B Yellow C Brown D Blue E Purple F White G Green H Red Sensor Location Intersection of right 7 intercostal space and right mid clavicular line Mid upper region of right gluteus Intersection of left 7 intercostal space and left mid clavicular line Right lumbar region at umbilical level Suprapubic region Left lumbar region at umbilical level Right mid inguinal region Left mid inguinal region Fitting Equipment on the Patient 37 PillCam Capsule Endoscopy AL Note Adjust the downlink loop to remove excess cable so that it fits closely to the patient s body To prevent damage to the wires do not forcibly bend the downlink loop in any way Before dispensing the PillCam capsule the equipment must be prepared y Caution e Make sure that there is no other PillCam capsule or other diagnostic capsule in the patient s gastrointestinal tract e Verify that the capsule expiration date has not passed see the date next to the icon on the packaging e If you are performing the procedure for the first time read the Package Insert Attaching the Sensors to PillCam Recorder The PillCam recorder is worn by patients during the procedure in the recorder pouch with shoulder strap or in the recorder belt with suspenders Make sure that these accessories fit the patient comfortably Recorder Pouch To fi
219. t the recorder pouch 1 With the patient standing hang the recorder pouch from the patient s shoulder as displayed in the illustration 2 Adjust the shoulder strap so that the recorder hangs at the patient s side at waist level with the supplied strap securing it to the waist PillCam Recorder Belt J Note There are three belt configurations PillCam recorder DR2 only e the standard recorder belt for patients over 85 lbs 40 kg e the small recorder belt for patients under 85 lbs 40 kg e the standard recorder belt with the belt extension for very large patients 38 Fitting Equipment on the Patient Preparing for PillCam Capsule Endoscopy Suspenders PillCam recorder DR2 in pouch on the left To fit the recorder belt 1 With the patient standing place the belt around the patient s waist 2 Adjust the belt to fit the patient Add the belt extension 1f needed 3 Make sure that the PillCam recorder DR2 pouch 1s at the patient s hip as shown here The belt has a Velcro strap for attaching the pouch allowing the patient to adjust the pouch as needed 4 Adjust suspender length and location to fit the patient PillCam Recorder DR2 and DR3 To assemble PillCam recorder accessories 1 Remove the PillCam recorder from the cradle If the PillCam recorder is properly initialized and ready for the procedure the capsule LED is constantly on in orange 2 Verify that the battery is fully charged e For PillCam
220. talization and surgery e Do not use any PillCam video capsule after its expiration date e Only one PillCam video capsule should be ingested at a time and only after confirmation that no other PillCam video capsules or ingestible diagnostic devices remain in the patient s body Adverse Events 5 PillCam Capsule Endoscopy e Instruct the patient to avoid biting the PillCam video capsule prior to swallowing e After ingesting the PillCam video 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 e Keep the magnet of the PillCam video capsule s packaging away from implants such as pacemakers defibrillators nerve stimulators and other devices that could be affected by proximity to a DC magnetic field e Instruct the patient to contact the physician immediately if after ingesting any PillCam video capsule there is any abdominal pain nausea or vomiting e Instruct the patient to wear the PillCam recorder throughout the procedure for as long as the PillCam recorder LED continues to blink at the ingested capsule s blinking rate e Instruct the patient not to sit on bare metal surfaces such as chairs with metal seating area during the procedure e Store all PillCam video capsules in a safe place out of the reach of children and infants e If contrary to instructions a patient ingests more than one PillCam video capsule instruct the
221. talled e RAPID Reader a limited version of the software all RAPID features are available except for creating videos ALG Note Your version of the RAPID may include multiple types of RAPID for example full software to install on your PC plus copies of RAPID Reader to install on multiple PCs used only for video review and reporting Throughout this manual RAPID implies any version unless specifically noted JTE Note RAPID v8 allows you to view videos created from procedures performed with PillCam SB capsules from before SB2 but you cannot check in a patient with this capsule type Before using the RAPID software you must configure and personalize it Refer to Configuring RAPID Software on page 135 for more details 18 PillCam Capsule Endoscopy System Components Chapter 4 Preparing for PillCam Capsule Endoscopy This chapter covers the following tasks which must be performed before administering a PillCam capsule 1 2 3 Preparing the patient see Preparing the Patient on page 19 Preparing the equipment see Preparing the Required Equipment on page 20 Creating patient instructions for the procedure see Creating Patient Instructions for the Procedure on page 22 Performing patient check in see Performing Patient Check in on page 24 Fitting Equipment on patient see Fitting Equipment on the Patient on page 32 Preparing the Patient Once it 1s decided that the patient should undergo capsule endoscopy
222. ted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the PillCam capsules are used exceeds the applicable RF compliance level above the PillCam capsules should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the PillCam capsules b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m IEC 61000 4 6 IEC 61000 4 3 192 Guidance and Manufacturer s Declarations Technical Description Recommended separation distances between portable and mobile RF communications equipment and the PillCam capsules The PillCam capsules are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the PillCam capsules can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the PillCam capsules as recommended below according to the maximum output power of the communications equipment 100 Not applicable For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter
223. ted to empty the Recycle Bin and if more space is needed to delete RAPID folders To free space for new videos delete RAPID studies from your hard disk or from E Videos AG Note It is recommended to back up the RAPID studies by saving them on removable media discs see Saving a Study to a CD DVD on page 83 You may then delete them from the computer s hard disk at any time or when prompted to do so by the RAPID software Failure to back up a RAPID video before deleting will cause the study to be permanently lost To delete videos from your hard disk 1 From the Home screen click Tools gt Delete Videos O fete i Regimen Manager Settings Atlas Delete Videos User Dictionary The Delete Video Folder window appears Delete Video Folder E f 3 43 Videos Navigate to a god n Sy CRT _ 194 1 07 Jan 09_1 folder to G Eso 3 delete 33 Montager Derek 555 89766 27 May 09 Sy P WC 3047655803 14 May 10_1 SQ THF 101 16 Apr 07 Sq THF 101 16 Apr 07_S1 THF 101 16 Apr 07_S2 S THF 101 16 Apr 07_S3 33 THF 101 16 Apr 07_S4 ee 2 Select the video folder you wish to delete The Delete button becomes available 3 Click Delete The selected RAPID folder and all its contents will be deleted 4 Empty the recycle bin Additional Settings 159 PillCam Capsule Endoscopy 160 Deleting Raw Data Files after Video Creation When creating videos in default mode the RAPI
224. terpreting RAPID Videos Section of GI tract Explanation Gastric Indicates the stomach The entrance to the stomach is marked by a blue dot Indicates the small bowel The entrance to the small bowel is marked by a green dot Indicates the large intestine The entrance to the large intestine is marked by a yellow dot e Defined landmarks on the capsule track are seen as small circles of the same color as the underlying GI region You can move the video display to a certain location by clicking that location on the localization track Hovering the mouse over a point on the localization track for 2 seconds shows the images at that location in a separate window The time indication of these images appears at the top 06 12 32 If instead of the localization track a small sketch of the abdomen appears with a red X in the upper left corner this means that the Localization feature is not enabled due to the detection of a faulty sensor When viewing an ESO video the PillCam logo appears instead of the localization track PillCam Progress Indicator The PillCam Progress Indicator appears only e for SB videos e after you have landmarked the first duodenal image and the first cecal image e inautomatic A mode for SB2 and SB3 AFR videos The PillCam Progress Indicator graphically presents the progress of reviewing the small bowel The slider on the left side shows an estimate of the percentage of the small bowel viewed
225. the workstation RAPID Installation Before installing RAPID on your computer it is recommended to be aware of the following prerequisites and other information Given Imaging Before installation it is highly recommended to format the hard disk in NTFS format if not already done You need at least 1 5 GB free space on your computer to install RAPID For high resolution monitors RAPID v8 offers the capability to resize and maximize the video view The registration window will open during the first time RAPID 1s opened and not at the end of the installation process For Dell 3500 systems and above the RAPID software 1s installed on an open system and therefore it 1s highly recommended to install anti virus software on the computer running RAPID 131 PillCam Capsule Endoscopy Main Endoscopy System Components Following is a list of items which you need to connect in order to set up the PillCam Capsule Endoscopy System RAPID workstation Monitor Keyboard Mouse Printer PillCam recorder with cradle Connecting the Components Warning A N The RAPID workstation has either an automatic or a manual voltage select switch In case the workstation has a manual switch e Verify that the workstation s voltage is set according to the local voltage prior to connecting the RAPID workstation to the wall outlet e Ifthe voltage is not set according to the local voltage do not connect the system Call Given Customer Support
226. the sensor belt for sanitary purposes some models may require the 32 Fitting Equipment on the Patient Preparing for PillCam Capsule Endoscopy fitting of a single use disposable protective sleeve while other models feature a reusable washable external fabric sleeve The image above of the PillCam sensor belt is for reference only Sensor belt models may differ from image ALG Note Refer to the product insert supplied with your sensor belt for full instructions on fitting usage cleaning and technical description Applying the PillCam Sensor Array The sensor array allows the PillCam recorder to collect localization data during a procedure The prescribing physician may request this To prepare the sensor array 1 Insert each sensor into an adhesive sleeve The sensor markings dots or this side up should face away from the adhesive side of the sleeve 2 To secure the sensor in the sleeve remove the liner from the topside of the lower lip at the opening of the adhesive sleeve and press both lips together Sensor inside adhesive sleeve between two layers Lower lip with liner on the top side 3 Place the sensors on the patient according to the appropriate placement guides see ESO Sensor Locations on page 35 SB Sensor Locations on page 36 or COLON 2 Sensor Locations on page 37 Necessary Equipment and Accessories To attach the sensor array to the patient you need the following equipment e Sensor array e Senso
227. tinal diverticular disease is unknown e The safety of the PillCam SB capsules has not been established in children below two years of age e The safety of the PillCam ESO capsule has not been established in patients below age 18 e The safety of the PillCam COLON capsules has not been established in patients below age 18 e Never connect the PillCam recorder to the sensor array while the PillCam recorder is in its cradle e Examine both video streams when viewing the results of a colon or an esophageal capsule endoscopy 6 Warnings Indications Contraindications Warnings Cautions PillCam Capsule Endoscopy System and its components need special precautions regarding Electromagnetic Compatibility EMC to avoid loss of image transfer resulting in video gaps PillCam Capsule Endoscopy System needs to be installed and put into service according to the Electromagnetic Compatibility EMC information provided in the accompanying documents The PillCam video capsule and PillCam recorder should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use 1s necessary the equipment or system should be observed to verify normal operation in the configuration in which it will be used Portable and mobile RF communications equipment can affect the PillCam video capsule and the PillCam recorder The PillCam video capsule may be interfered with by other equipment even if that other equipment complies with CISPR
228. tion If you wish to de identify the video in the study select the check box De identify at the bottom of the screen The report will not be de identified Using the Study Manager Reviewing and Interpreting RAPID Videos 4 Click Next 5 Select Zip file under Select destination and click Next The Save screen appears 6 If you would like to save to another location click Browse and navigate to the desired location and click Save 7 A screen appears showing the progress bar and Saving zip file 8 When the progress bar 1s full the last screen appears with the message Zip study successful Click Close Delete The delete function allows you to remove studies entirely or partially from archives To delete a study 1 Select the relevant study and click Delete The Delete files screen appears 2 If you wish to delete the entire study select the check box Delete entire study at the top 3 If you wish to delete specific files select them and click Delete Videos 744 1 URU _ 24 Feb 11 NB Video 744 1 URU _ 24 Feb 11 GS Findings 744 1 URU _ 24 Feb 11_Findings JG Findings RecoveredFindings OFA Report 744 1 URU _ 24 Feb 11 08 03 17 09 12 17 PM To delete multiple studies 1 Select the relevant studies by clicking on one and holding the Control button on the keyboard and selecting another study 2 Once the studies to be deleted are selected click the Delete button An attention screen appears
229. tionally add by selecting from a list of additional check in information fields You can also add and name a new column User Column To add or remove columns 1 Right click anywhere in the area where the studies are displayed and select Manage Columns The Manage Columns screen appears On the right is the list of currently Displayed columns in the Study Manager The columns with a star icon next to them are fixed and cannot be removed or renamed The left is a list of available columns to choose from 2 To change the left to right order of the displayed columns in the Study Manager screen select the column you wish to move in the window on the right and click or LA 3 Select any column names that are listed in Available columns on the left side and click the right arrow LEM to display them in the Study Manager screen They will be added to the end of the list in the window on the right The position in the list can also be changed 4 Select any columns that are listed in Displayed columns and click the left arrow E to remove them from the Study Manager screen Loading a Study with the Study Manager 81 PillCam Capsule Endoscopy 82 8 9 To create a new column click Create Type in the name of your new column and click Save The new column will appear in the Available columns list with a user column icon A next to 1t To display this new column select 1t and click the right arrow E tt will appear at the bott
230. to continue When the Patient Check In Complete screen appears click Ready to proceed Performing Patient Check in 31 PillCam Capsule Endoscopy NS Note When the patient check in is complete the capsule LED on the PillCam recorder lights up in orange After patient check in keep the PillCam recorder in its cradle until the capsule ingestion procedure begins Update Patient Details Patient details are collected during the Patient Check in process However RAPID allows you to change or update all the patient information after a video creation To update patient details 1 Find the study in the Study Manager 2 Right click the study and select Update Patient Details The following screen appears Make the desired changes and click Next until you have completed your update Last P First iwc Middle ID 3047655803 Gender ai Male Birth Date 21 Sep 57 Procedure Date 14 May 10 Mandatory field ose A ON Ge 3 Click Save on the last screen Fitting Equipment on the Patient The following section details the instruction for preparing and fitting the patient with the recording equipment required for the capsule endoscopy procedure Applying the PillCam Sensor Belt The sensor belt is used for SB and COLON procedures and consists of a flat flexible belt like sensor arrangement worn around the patient s waist over a single thin layer of natural fabric such as a T shirt Depending on
231. to the appropriate decimal place PillCam SB Capsule Properties Physical Dimensions Weight Material Optical Illumination of imaging heads Field of view Effective visibility Magnification Min detectable object Frequency Band width Modulation ERP nW Operational Frame rate Operating time Chemical safety Battery type Operating temperature Storage temperature System Specifications Length 26 4 mm Diameter 11 4 mm 3 3 gr Biocompatible plastic 6 white light emitting diodes 1 140 ISO 8600 3 Distance 3 cm 1 8 At least 0 1 mm 434 1 MHz 1 6 MHz MSK 57 2 fps 7 1 hours Resistant to dissolution in pH 2 to pH 8 Silver Oxide batteries 20 40 C 0 50 C 179 PillCam Capsule Endoscopy 180 PillCam SB 2 Capsule Properties Physical Optical Operational Dimensions Weight Material Illumination of imaging heads Field of view Effective visibility Min detectable object Frequency Band width Modulation ERP nW Frame rate Operating time Chemical safety Battery type Operating temperature Storage temperature Length 26 3 mm Diameter 11 4 mm 2 9 gr Biocompatible plastic 4 white light emitting diodes 1 156 ISO 8600 3 Distance 3 cm At least 0 1 mm 434 1 MHz 1 6 MHz MSK 16 either 2 or 4 fps two capsule versions gt 8 hours Resistant to dissolution in pH 2 to pH 8 Silver Oxide batteries 20 40 C 040 C
232. tors to the PillCam sensors the PillCam recorder DR3 is limited to 400 use cycles The RAPID will alert the user when the number of recorder uses is close to the allowed limit ALG Note SD Card The SD card in the PillCam recorder DR3 may not be used externally to perform a patient check in Use of SD cards not supplied by Given Imaging in the PillCam recorder DR3 may cause the device to malfunction or lead to data corruption or loss Turning On and Off The illustration below shows the PillCam recorder DR3 sitting in the cradle Capsule and message LEDs ON OFF button Line for status icons Acknowledge button Message area Navigation buttons a Cradle A PiliCam Recorder DR Know Your PillCam Recorder The PillCam recorder DR3 is automatically on when it is in its cradle When removed from the cradle 1t may be turned off and on again using the On Off button The On Off button is on the left side of the PillCam recorder DR3 e To turn on press and hold the On Off button for 5 seconds until you see the startup screen All LEDs start to flash The full start up sequence takes about one minute e To turn off press and hold the On Off button for 5 seconds until the PillCam recorder DR3 beeps and the screen turns off and the button LEDs turn black AS Note Automatic Shutdown e After the PillCam recorder has been checked in it goes into a standby mode when removed from its cradle If after 9 minutes no pair
233. transmitter Recommended separation distance Conducted RF 3 VRMS IEC 61000 4 6 150 kHz to 80 MHz Radiated RF d 1 2 P 80 MHz to 800 MHz range Os d 2 3 P 800 MHz to 2 5 GHz range 198 Guidance and Manufacturer s Declarations Technical Description Guidance and manufacturer s declaration electronic emissions NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NOTE 3 P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m NOTE 4 Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range NOTE 5 Interference may occur in the vicinity of equipment marked with the following symbol C a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the PillCam recorder DR2 is used e
234. ty area e Ribbon Groups Each tab has several groups that show related items together e Commands A command is simply a button a box to enter information or a menu Ribbon Tabs Quick Access Toolbar These Hide the Ribbon Click either tab on the commands are available in all Need more space on your screen ribbon to display its screen and ribbon views Click this icon to hide or show the buttons and commands ribbon pd D b gt Pa SBI CQV QV A ee ee wren Thumbnails Comments Editor f se On 140 Localization F Show All Single Dual Quad Mosaic Adjust oor SB Progress Bar 3 Full Screen i Preview Ty Review Viewing Layouts Image Adjustment Zoom Show File View uN Box Launchers Ribbon Groups Click the File tab Each ribbon tab contains to enter File view If you see this icon next to any groups and each group contains where you can ribbon group label click it to open a a set of related commands open and save screen with more options for that your RAPID files group The RAPID interface enables multiple ways to access functions e by clicking a button e by right clicking to select an option e by using the menu options Dialog Box Launchers Some ribbon groups have a small diagonal arrow in the lower right corner that when clicked will display certain options that are not visible In the RAPID interface there are three screen launchers e inthe View screen in the Preview ribbon group e inthe
235. ty should gt 95 dip in Uy gt 95 dip in Uy be that of a typical Voltage dips _ for 0 5 cycle for 0 5 cycle commercial or hospital short 40 U7 40 U7 environment If the user of interruptions 60 dip in Uy 60 dip in Uy the PillCam recorder DR2 and voltage for 5 cycles for 5 cycles requires continued variations on operation during power power supply 70 Ur 70 Uy mains interruptions it is input lines 30 dip in Ur 30 dip in Ur recommended that the for 25 cycles for 25 cycles PillCam recorder DR2 be IEC 61000 4 11 lt 5 U lt 5 Uz powered from an gt 95 dip in Ur gt 95 dip in Uy uninterruptible power for 5 sec for 5 sec supply or a battery Power Power frequency magnetic frequency 50 fields should be at levels 60 Hz characteristic of a typical magnetic field location in a typical commercial or hospital IEC 61000 4 8 environment NOTE Uy is the AC mains voltage prior to application of the test level Guidance and manufacturer s declaration electronic emissions The PillCam recorder DR2 is intended for use in the electromagnetic environment specified below The customer or the user of the PillCam recorder DR2 should assure that it is used in such an environment Portable and mobile RF communications equipment should be used no closer to any part of PillCam recorder DR2 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the
236. u to scroll to the rest of the images ALG Note The RAPID Atlas by no means replaces careful diagnosis from a trained physician Comparing Video Images to Atlas Images To compare an image from the current video Current image with any of the images from the RAPID Atlas select CEST Diagnosis or Lewis Score tabs to display images in that category 122 RAPID Atlas Reviewing and Interpreting RAPID Videos Select from the images that appear on the right side of the screen by clicking on the image A comparison screen with the current image and the Atlas provided image appears Current Image Atlas Image NSAID Enteropathy CEST Small Bowel gt Lumen gt Stenosis Type Benign intrinsic Small Bowel gt Excavated lesions gt Ulcer Both images appear enlarged side by side The Current Image on the left and the image from the RAPID Atlas on the right including all the comments case history and any additional available information on the Atlas image If there is more text than available space on the screen a scroll bar appears next to the text Atlas Image Export You can export images from the Atlas to your computer as follows 1 Right click an image on the Atlas screen and select Export The Export Atlas Image screen appears 2 Browse for the location on your computer where you wish to save the image 1f desired rename the image and click Save Lewis Score The Lewis Score is an aid to diagnosis that pr
237. uctions field that will appear on the printout for that specific regimen a Regimen Name Picosulfate Boosts O n Background Information Approved By Dr Schnaider Approval Date 24 5 2012 1 packet 1 packet Mg SPS Boosts Prokinetics 20mg Domperidone Meal at the end of procedure d Printed Information Instructions Recorder Display When HH MM Trigger Instructions for Patient 01 00 v After ee a Ingest ENTER LOCAL BRAND NAME OF 20mg DOMPERIDONE with a gl 00 00 v After SB detection Prepare 1 packet of ENTER LOCAL BRAND NAME OF SODIUM PICOSUL 03 00 7 After previous event __ Prepare 1 packet of ENTER LOCAL BRAND NAME OF SODIUM PICOSUL _ 02 00 v After previous event I Insert ENTER LOCAL BRAND NAME OF 10mg BISACODYL SUPPOSITOR A A You may eta oht maa MMM Additional Instructions Following capsule ingestion maintain a complete fast no drinking until instructed to do otherwise by the recorder alerts Remain active throughout your exam no sleeping Approval This Regimen is approved 6 The Recorder Display column on the left lists the event numbers that will be displayed on the PillCam recorder LCD screen along with the corresponding alert 7 The Trigger column on the right of the timing column indicates that the event will activate the recorder instruction This can be delayed by using the drop down list on the left of each trigger 8 The regimens contain editable instructio
238. udy with the Study Manager Reviewing and Interpreting RAPID Videos ALG Note Adding an archive provides a visual link to the directory using the Study Manager It does not copy the data locally to your computer Removing an archive using the Delete button does not delete data from the directory but only the path to the directory To add an archive 1 Click the Add button at the bottom left of the Study Manager screen The Add Archive screen appears Add Archive Specity archive path and name Archive path C Archive 1 2 Enter the archive path and the archive name that will appear below the archive e To browse for the archive on the local computer or on the network click the Browse button e The Browse for Folder screen appears Navigate to the desired archive and click OK 3 Click Finish When the Study Manager scans the archive the archive icon will display Scanning below the archive The status bar will display Loading Studies until all studies are loaded and the status bar will display Loading studies successful ALG Note During archive scanning studies that already appear in the Study Manager screen can be opened Archive Options When right clicking on a selected archive in the Study Manager the following options are available e Remove Remove the archive path from the Study Manager To remove the CD DVD from the disk drive or any portable drive from the USB connection click the Eject button A
239. ul interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures e Reorient or relocate the receiving antenna e Increase the separation between the equipment and receiver e Connect the equipment into an outlet on a circuit different from that to which the receiver is connected e Consult the dealer or an experienced radio TV technician for help PillCam Recorder DR3 The PillCam recorder DR3 cradle has the following LEDs Battery pack is On ready for use To charge the PillCam recorder 1 Plug the power cable into the cradle and plug the power cable into the wall outlet 2 Insert the PillCam recorder into the cradle The bottom LED is orange when charging the battery When the PillCam recorder is fully charged the bottom LED turns green 3 Leave the PillCam recorder in its cradle until the next examination 164 PillCam Recorder Maintenance PillCam Equipment Maintenance PillCam Recorder DR2 Charging Adaptor with battery Green orange and red LEDs Make sure the PillCam recorder is fully charged for SB and COLON procedures and that at least two of the four battery LEDs light up
240. uttons The action buttons located on the bottom of the Study Manager screen enable several commands like opening a study in RAPID deleting studies and export To perform an action on a study select the study by clicking the row containing the relevant study and click one of the following action buttons Button Action Adds an archive to the Study Manager screen see Adding an Archive on page 76 Ejects a CD DVD from CD drive and ejects any flash drive connected to USB This will remove the archive from the Study Manager Opens the video and findings of the selected study in the RAPID software See Open on page 83 Exports the selected study or specific files of the study to a CD DVD or another archive see Export on page 83 Deletes the selected study see Delete on page 87 Deleting a study in the Study Manager deletes all data including procedure videos from the source directory Opens the report of the selected study see Open on page 83 Opens Offline study archive which displays the list of the studies which were stored on a removable storage media but are now not accessible see Offline Studies on page 88 Closes Study Manager screen This can also be performed by clicking the Escape button on the computer s keyboard IL a Note For Delete and Export commands you can select multiple studies to perform the command Click the row of the first study press and hold SHIFT on your keyboard and select the last stud
241. vel Guidance and Manufacturer s Declarations 201 PillCam Capsule Endoscopy 202 Guidance and manufacturer s declaration electromagnetic immunity The PillCam recorder DR3 is intended for use in the electromagnetic environment specified below The customer or the user of the PillCam recorder DR3 should assure that it is used in such an environment Conducted RF 3Vims IEC 61000 4 6 150 kHz to 80 MHz Radiated RF IEC 61000 4 3 3Vims 150 kHz to 80 MHz Portable and mobile RF communications equipment should be used no closer to any part of PillCam recorder DR3 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P Recommended separation distance d 1 2 P 80 MHz to 800 MHz range d 2 3 P 800 MHz to 2500 MHz range NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NOTE 3 P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m NOTE 4 Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency ra
242. w of the RAPID Interface Reviewing and Interpreting RAPID Videos Quick Access Information about the Video image Toolbar open study Fe Ge E Bar RAPID PillCamSB Physician Dr Schnaider _ CRT ID 194 1 1 7 2009 EN View b9 gt L gt 00 aa Y Thumbnafs Comments Editor T ten A Mode Si On 166 Localizati n SBI CQV QV ingle Dual Quad Mosaic Show Full Adjust mmm SB Progre s Bar All Screen Preview amp Review Viewing Layouts Image Adjustment Zoom o AOO A A Me 01 48 40 Viewing Speed 19 i y o B a ee 00 05 32 00 08 55 00 25 51 00 38 34 00 42 33 00 53 20 20m 18s First Esop Z Lin t Gast First Du Localization Progress indicator Video play buttons Thumbnails View Ribbon The View ribbon is divided into several groups enabling many different functions The buttons and commands are organized in the following logical groups o Preview Review Viewing Layouts Image Adjustment Zoom Show Preview Review Groups Below is a description of the Preview Review group buttons and the commands that can be performed for viewing the capsule endoscopy video This group of buttons enable to preview the video and then to review and read the complete video using the Viewing Layouts described in the next buttons grouping below For a complete explanation on the use of the features described refer to the cross reference provided if available
243. wer endoscopy e It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia IDA not detected by upper and lower endoscopy The Suspected Blood Indicator SBI feature is intended to mark frames of the video suspected of containing blood or red areas The PillCam SB capsule may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age PillCam ESO The PillCam Capsule Endoscopy System with PillCam ESO capsules 1s intended for the visualization of esophageal mucosa for diagnosis of esophageal disorders PillCam COLON The PillCam Capsule Endoscopy System with the PillCam COLON capsule 1s intended for the visualization of the colon for diagnosis of colonic disorders NS Note The procedure may involve intake of laxatives and prokinetic agents Refer to the labeling of these agents for their contraindications Given Imaging PillCam Capsule Endoscopy Contraindications PillCam SB The PillCam SB capsules are contraindicated for use under the following conditions e In patients with known or suspected gastrointestinal obstruction strictures or fistulas based on the clinical picture or preprocedure testing and profile e In patients with cardiac pacemakers or other implanted electromedical devices e In patients with dysphagia or other swallowing disorders NS Note e In patients who cann
244. with a sensor array the section containing the currently displayed images lights up on the Colon Location Diagram Passage Times Passage time is the time the capsule spent in a given region of the GI tract Calculation of passage times is enabled only after you segment the video from the GI tract by labeling the first images of the different sections of the GI tract When you identify and label the first and last images of the gastric SB or cecal section of the GI tract the RAPID software calculates the relevant passage times based on the time tags of the landmarked thumbnails The RAPID software displays this data at the bottom of the Localization Display section AC Note The estimation of the passage times is based solely on the physician s identification of the first image of each section of the GI tract Comparing Thumbnails There are three scenarios to compare images in RAPID v8 e Atlas comparison compare a RAPID video thumbnail to Atlas images see Comparing Video Images to Atlas Images on page 122 e One thumbnail comparison compare a thumbnail to itself in different display modes 1 e FICE or Blue mode e Two thumbnail comparison compare two different thumbnails in the same video Using RAPID to View a Video Reviewing and Interpreting RAPID Videos To compare a thumbnail to itself One frame comparison 1 Click the thumbnail you wish to examine A dark blue background appears around the thumbnail 2 Right
245. wo images appear one for each head Using RAPID to View a Video Reviewing and Interpreting RAPID Videos e You can move the video display to a certain location by clicking that location on the color bar e SBI indicators small red tics appear in the top part of the Time bar Color bar see SBI View on page 102 The area before the landmarked first duodenal image 1s gray e GI divisions are colored in a narrow strip below the Color Bar according to defined Landmarks The regions have specific colors Gl data display Time Bar slider Color Region of Gl Blue Esophagus Turquoise Stomach ee GA ee Orange Small intestine 00 57 08 01 00 27 Green Colon large intestine e Lines in region specific colors connect the location on the time bar and the thumbnails e Before defining the landmarks the narrow strip below the Color Bar is gray Time Indication The time indication box displays the time of the frame in hours minutes and 06 15 09 T E 06 15 09 seconds after the capsule starts acquiring images in the procedure Creating and Annotating Thumbnails Thumbnails are images captured from the video Some images are automatically created such as those that are marked during real time viewing with PillCam recorder DR3 These thumbnails have the default annotation of marked during real time viewing When reviewing the video the physician may capture any image of interest for further scrutiny The images app
246. xceeds the applicable RF compliance level above the PillCam recorder DR2 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the PillCam recorder DR2 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and the PillCam ESO capsule The PillCam recorder DR2 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the PillCam recorder DR2 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the PillCam recorder DR2 as recommended below according to the maximum output power of the communications equipment oa otto o or 1 otto tt o w otto For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation i
247. y 1 2 3 4 Open RAPID Make sure the appropriate battery 1s inside the PillCam recorder Insert the PillCam recorder into the cradle From the Procedures screen select the relevant PillCam recorder by clicking the Recorder bar The buttons on the right side of the screen become available Click to open the Recorder Information screen At the bottom of the screen click Start Discharge A message appears Discharge may take up to 12 hours Are you sure you want to start discharge Click OK While the battery is being discharged its battery status indicates Discharging e inthe bottom left corner of the Recorder Information screen e inthe PillCam recorder DR2 bar in the Recorders screen e the orange LED on the cradle blinks To return to other RAPID functions click Close If you need to stop the discharge also for automatic discharge while it 1s in progress return to the Recorder Information screen and click Stop Discharge If you stop the automatic discharge process in the middle the battery LEDs may not indicate the correct battery status ALG Note Do not charge of discharge the battery in the vicinity of the patient PillCam Recorder Maintenance PillCam Equipment Maintenance PillCam Sensor Maintenance Cleaning the PillCam Sensor Belt AOS Note Refer to the product insert supplied with your sensor belt for full instructions on fitting usage cleaning and technical description Cleaning the Pill
248. y you wish to select If not all the studies are in rows next to each other press and hold CTRL on your keyboard and select the studies one by one You can then either click Delete or Export The number of selected studies is displayed in the Status bar lt fabs Search Function At the top of the Study Manager screen the following search and filter functions enable to search for a study in a selected archive e Text search by entering part of the name or the entire name of the patient findings procedure or other free text e Capsule Type filter the search by selecting from the drop down list the type of capsule procedure Loading a Study with the Study Manager 79 PillCam Capsule Endoscopy 80 e Procedure Date filter the search by selecting from the drop down list the procedures performed in a specific time window in the last days or weeks or even by a specific date After entering one or more search criteria the Study Manager will search and display only relevant studies The criteria that were searched will be highlighted in green In the example below the following search criteria was entered e Text Active bleeding e Capsule Type SB e Procedure Date All First recs Capsule Procedure Referring pa e Video 7 See aie Hame ID Gender Type Dete Physician Physician AS Created 7 Findings Reports 1941 Male se NS All SB capsule procedures were displayed and highlighted Additiona

PillCam Capsule Endoscopy User Manual, RAPID

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