® PillCam Capsule Endoscopy User Manual RAPID® v8.
COPYRIGHT Copyright ©2001–2015 Given Imaging Ltd. TRADEMARKS Copyright ©2001-2015 Given Imaging Ltd. GIVEN, GIVEN & Design, PILLCAM, PILLCAM & Logo, RAPID, RAPID ACCESS, BRAVO, BRAVO PH SYSTEM, DIGITRAPPER, MANOSCAN, MANOSHIELD, MANOVIEW, GASTROTRAC, GEROFLEX, VERSAFLEX, ACCUTRAC, ACCUVIEW, POLYGRAF ID, SMARTPILL, MOTILIGI, SMARTBAR, and THE MEASURE OF GI HEALTH are trademarks and/or registered trademarks of Given Imaging Ltd., its subsidiaries and/or affiliates in the United States and/or other countries.
Table of Contents Chapter 1 Using This Guide .......................................................................................... 1 Conventions ............................................................................................................................. 1 Chapter 2 Indications, Contraindications, Warnings, Cautions ................................ 3 Indications for Use...................................................................................................................
PillCam Capsule Endoscopy Chapter 4 Preparing for PillCam Capsule Endoscopy ............................................. 37 Preparing the Patient ............................................................................................................ Preparing the Required Equipment ..................................................................................... Connecting the PillCam Recorder to RAPID for Check-in ................................................
Error Messages....................................................................................................................... 73 PillCam Recorder DR2........................................................................................................... General ............................................................................................................................. Turning On and Off .............................................................................................
PillCam Capsule Endoscopy Chapter 8 Reviewing and Interpreting RAPID Videos .............................................. 97 Loading a Study with the Study Manager ........................................................................... 97 Archives............................................................................................................................ 99 Adding an Archive .................................................................................................................
Circumference Scale ............................................................................................................ 135 Polyp Size Estimation .......................................................................................................... 135 Using Localization and Landmarks ................................................................................. 137 Landmarks ....................................................................................................................
PillCam Capsule Endoscopy Video Tab ....................................................................................................................... 173 Video Creation Section ......................................................................................................... 174 Video Data Management Section ......................................................................................... 174 Research Tools Section .......................................................................
Appendix A4 Troubleshooting ....................................................................................... 207 RAPID Video ......................................................................................................................... Saving and Opening Videos ............................................................................................... Printer ...............................................................................................................................
PillCam Capsule Endoscopy viii 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: ֠ Note When connecting more than one PillCam recorder DR2 to the computer, use a USB-powered hub.
PillCam Capsule Endoscopy 2 Conventions
Chapter 2 Indications, Contraindications, Warnings, Cautions Indications for Use PillCam SB The PillCam Capsule Endoscopy System with the PillCam SB capsule is intended for visualization of the small bowel mucosa. • The PillCam Capsule Endoscopy System with the PillCam SB capsule may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
PillCam Capsule Endoscopy PillCam COLON The PillCam COLON 2 capsule endoscopy system is intended to provide visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible. ֠ Note The procedure may involve intake of laxatives and prokinetic (“push”) agents to aid in advancement of the capsule through the digestive tract.
Indications, Contraindications, Warnings, Cautions • In patients with dysphagia or other swallowing disorders. • In patients with allergies or known contraindication to the medications and preparation agents used in the procedure as described in the relevant instructions for use. Adverse Events Potential adverse events associated with the use of this device may include delayed or no excretion of the capsule, aspiration, obstruction, perforation, and mucosal injury or bleeding.
PillCam Capsule Endoscopy system be 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. • Examine both video streams when viewing the results of a COLON capsule endoscopy.
Indications, Contraindications, Warnings, Cautions • 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. • Review the time bar of the RAPID video to determine if video gaps exist, which may result in the need to repeat the capsule endoscopy procedure. This is important if the procedure results in a normal or negative capsule endoscopy examination.
PillCam Capsule Endoscopy Cautions A caution indicates a condition that may damage the equipment. • 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.
Indications, Contraindications, Warnings, Cautions • PillCam capsule endoscopy offers a simple, safe and non-invasive alternative to traditional imaging procedures. • The PillCam patency capsule provides a simple and convenient means to verify functional patency of the GI tract in patients with known or suspected strictures. Risks • A normal or negative capsule endoscopy examination does not exclude the possibility of colon polyps or colon cancer. • PillCam capsule endoscopy is not for everyone.
PillCam Capsule Endoscopy Essential Performance PillCam Video 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.
Indications, Contraindications, Warnings, Cautions 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.
PillCam Capsule Endoscopy Accuracy of the Device—ESO The PillCam Capsule Endoscopy System with the PillCam ESO 1 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.
Indications, Contraindications, Warnings, Cautions Accuracy of the Device—UGI The PillCam Capsule Endoscopy System with the PillCam UGI capsule was evaluated in adults with acute upper gastrointestinal hemorrhage who were hemodynamically stable presenting to the emergency departments of two academic medical centers There were 49 patients enrolled in the clinical study of which 46 patients underwent an UGI capsule endoscopy (CE, PillCam ESO 2), and 47 patients underwent an upper endoscopy examination within
PillCam Capsule Endoscopy Diagnosis and detection of gross blood by capsule endoscopy compared to EGD 14 7 007MIV No No Normal Normal 8 008XKK Yes No Coffee grounds Normal 9 001-YN No No Gastritis, duodenitis Gastritis 10 002SLY No Yes Esophageal Varices Esophageal Varices 11 003WLC No No Gastritis Normal 12 004YTL No No Gastritis Gastritis 13 005SCW Yes Yes Gastric Ulcer Gastric Ulcer 14 006WCL Yes Yes Gastric Ulcer Gastric and duodenal AVMs 15 007SCC No
Indications, Contraindications, Warnings, Cautions Diagnosis and detection of gross blood by capsule endoscopy compared to EGD 29 021CKH Yes Yes Duodenum Ulcer Gastric and Duodenal Ulcers 30 022FKC Yes No Blood in duodenum Gastric Ulcer 31 023YTP No No Normal Gastritis 32 024KST Yes No Coffee grounds in stomach & duodenum Gastritis 33 025FHL Yes No Ulcer with overlying clot Hiatal Hernia 34 026KHW Not applicable Not applicable Patient withdrew Patient withdrew 35 027SML
PillCam Capsule Endoscopy Diagnosis and detection of gross blood by capsule endoscopy compared to EGD 49 041K-L Yes No Normal Gastritis The absence of blood when performing an evaluation with the PillCam UGI video capsule does not exclude the presence of a significant bleeding site in the acute upper gastrointestinal (esophagus, stomach and duodenum). Reference: [1] Gralnek IM1, Ching JY, Maza I, et al. Capsule endoscopy in acute upper gastrointestinal hemorrhage: a prospective cohort study.
Indications, Contraindications, Warnings, Cautions Accuracy of the Device—COLON 2 Clinical Validation Study and Interpretation of Results Evaluation of Capsule Endoscopy with PillCam COLON 2 in Visualization of the Colon (MA-204) Study Design A prospective, multi-center study (MA-204) was conducted to evaluate the clinical effectiveness of the PillCam COLON 2 (colon capsule endoscopy or CCE) device.
PillCam Capsule Endoscopy Following capsule ingestion and depending on capsule progression through the digestive tract, subjects were required to take a boost of an additional volume of laxative (SuPrep) in order to enhance capsule propulsion and maintain adequate cleansing of the colon. Per procedure progress, in case the capsule remained in the stomach more than an hour after ingestion a prokinetic medication may have been administered.
Indications, Contraindications, Warnings, Cautions Analysis of Agreement Location-based and size-based analyses of the agreement of CCE with OC were conducted. Two polyp size thresholds, 6 mm and 10 mm, were considered for defining a subject as positive for a polyp. If one or more polyps were identified on OC, the polyp with the largest estimated diameter was used for comparison purposes and is referred to as the ‘reference’ polyp.
PillCam Capsule Endoscopy Table 4: Observed Categorical Data, 10 mm Threshold OC CCE negative positive negative 579 27 606 positive 44 50 94 623 77 700 Table 5: Percent Agreement of CCE with OC Percent Agreement Polyp Size Threshold ≥ 6 mm ≥ 10 mm Positive Percent Agreement (95% CI)a 68.8% (132/ 192) 95% CI (61.7%, 75.2%) 64.9% (50/ 77) 95% CI (53.2%, 75.5%) Negative Percent Agreement (95% CI) a 81.3% (413/ 508) 95% CI (77.6%, 84.6%) 92.9% (579/ 623) 95% CI (90.6%, 94.8%) a.
Indications, Contraindications, Warnings, Cautions Safety Only one (0.1%) case (out of 884 cases) was reported within this study as a serious adverse event (abdominal pain related to OC procedure). The event resolved the following day. A total of 142 non-serious adverse events related to the study occurred in 101 (11%) out of 884 subjects. • Three adverse events were reported as related to the capsule procedure and resolved within the same day (i.e.
PillCam Capsule Endoscopy Table 6: Examples of Subject Level Classificationsa Subject Segment OC max Polyp Size CCE max Polyp Size 1 cecum - - 1 ascending - - 1 transverse 5 - 1 desc-sigmoid - 6 1 rectum 20 Subject Level classification 2 cecum - - 2 ascending - - 2 transverse 5 - 2 desc-sigmoid - 5 2 rectum 8 Subject Level classification 3 cecum - 4 3 ascending 9 - 3 transverse - - 3 desc-sigmoid - - 3 rectum 11 5 Subject Level classification
Indications, Contraindications, Warnings, Cautions Table 6: Examples of Subject Level Classificationsa Subject Segment OC max Polyp Size CCE max Polyp Size 5 cecum - 7 5 ascending - - 5 transverse - - 5 desc-sigmoid - - 5 rectum 5 Subject Level classification 6 Cecum - 5 6 Ascending - 5 6 Transverse - 5 6 desc-sigmoid - 5 6 rectum 5 Subject Level classification 7 cecum - - 7 ascending - - 7 transverse - - 7 desc-sigmoid - - 7 rectum - Subject
PillCam Capsule Endoscopy Table 6: Examples of Subject Level Classificationsa Subject Segment OC max Polyp Size CCE max Polyp Size 7 ascending - 60 7 transverse - - 7 desc-sigmoid - 6 7 rectum - Subject Level classification 7 cecum - - 7 ascending 8 11 7 transverse - - 7 desc-sigmoid - - 7 rectum - Subject Level classification 7 cecum - - 7 ascending - 6 7 transverse 18 - 7 desc-sigmoid - - 7 rectum - Subject Level classification CCE Classificati
Indications, Contraindications, Warnings, Cautions Published Studies There have been two published studies utilizing PillCam COLON 2 which are summarized below. The statistical analysis performed on the two published studies below is different from the FDA clinical study presented above (Evaluation of Capsule Endoscopy with PillCam COLON 2 in Visualization of the Colon (MA-204)).
PillCam Capsule Endoscopy The accuracy of the PillCam COLON 2 capsule endoscopy system for patients with polyps is listed in the table below: Accuracy ≥ 6 mm ≥ 10 mm Sensitivity % (95% CI) 89% (70%–97%) 88% (56%–98%) Specificity % (95% CI) 76% (72%–78%) 89% (86%–90%) Second-generation colon capsule endoscopy compared with colonoscopy1 This trial was conducted in eight European sites by Spada et al to assess the ability of the PillCam COLON 2 capsule endoscopy system to detect polyps and other path
Indications, Contraindications, Warnings, Cautions The accuracy of the PillCam COLON 2 capsule endoscopy system for patients with polyps is listed in the table below: Accuracy ≥ 6 mm ≥10 mm Sensitivity % (95% CI) 84% (74%–95%) 88% (76%–99%) Specificity % (95% CI) 64% (52%–76%) 95% (90%–100%) Accuracy of the Device—COLON 2 27
PillCam Capsule Endoscopy 28 Accuracy of the Device—COLON 2
Chapter 3 Welcome to PillCam Capsule Endoscopy What is PillCam Capsule Endoscopy? The PillCam capsule endoscopy procedure is a 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.
PillCam Capsule Endoscopy There are three PillCam capsule types, supported by the current PillCam capsule endoscopy system. Each is optimized for a different bowel segment, some with one video head and some with two video heads: PillCam SB capsules: small bowel PillCam ESO/UGI capsules: esophagus and upper GI PillCam COLON capsule: colon PillCam SB capsules contain one video camera.
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 is 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: ! Caution • Keep the PillCam capsules in their box until use.
PillCam Capsule Endoscopy 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 sensor array: The sensors of the sensor array are attached to the patient's skin. The sensor locations depend on the procedure type.
Welcome to PillCam Capsule Endoscopy 1 2 3 4 5 ֠ 1 2 3 6 Note Certain key functions described in this manual are accessed from the Home screen. All future mention of Home screen, such as From the Home screen, click the Tools button refers to the screen described above. 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.
PillCam Capsule Endoscopy 4 5 Tools: Clicking this button opens a menu that provides access to: • Regimen Manager: Opens a software tool for creating or modifying capsule ingestion regimen instructions for the patient (see Regimen Manager on page 183). • Settings: Enables user configuration of RAPID settings (see RAPID Settings on page 170).
Welcome to PillCam Capsule Endoscopy • RAPID Reader: A limited version of the software; all RAPID features are available except for creating videos. ֠ Note • Your version of 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). • You cannot install RAPID Reader on a PC on which RAPID was already installed.
PillCam Capsule Endoscopy 36 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: • Preparing the patient (see Preparing the Patient on page 37) • Preparing the equipment (see Preparing the Required Equipment on page 38) • Creating patient instructions for the procedure (see Creating Patient Instructions for the Procedure on page 40) • Performing patient check-in (see Performing Patient Check-in on page 43) • Fitting Equipme
PillCam Capsule Endoscopy h. Instruct the patient to contact the medical staff if one of the adhesive sleeves detaches from the patient's body. i. For procedures involving visualization of the colon: use the Regimen Manager to create and select pre- and post-ingestion instructions (see Regimen Manager on page 183); 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.
Preparing for PillCam Capsule Endoscopy 3. Click Patient Check-in ֠ on the RAPID Home screen. Note • When the DR3 battery approaches 400 cycles, RAPID will display a warning. Contact customer service for a replacement battery when this battery warning appears, or when the battery reaches 3 years of service, whichever occurs first. • Do not remove the PillCam recorder from its cradle before the end of the check-in process. 4. In the Procedures screen, select the Recorders tab. 5.
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 174). (Not available for RAPID Reader.) Starts or stops video creation from the raw data on the PillCam recorder. Displays all technical details of the PillCam recorder.
Preparing for PillCam Capsule Endoscopy Post-ingestion Instructions for Procedures Involving Colon Visualization In general, the post-ingestion instructions should result in the preservation of proper cleanliness of the colon during the 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.
PillCam Capsule Endoscopy 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: • 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 o
Preparing for PillCam Capsule Endoscopy Performing Patient Check-in Patient check-in is 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 is cleared and the new patient and regimen information is saved to the PillCam recorder.
PillCam Capsule Endoscopy ! Caution When placed in the cradle, RAPID 8.3 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. • For the PillCam recorder DR3, RAPID will perform a mandatory update. • ֠ 44 For the PillCam recorder DR2, follow the instructions detailed in the Note below.
Preparing for PillCam Capsule Endoscopy The Patient Check-in wizard opens. 5. Click Next to continue. The first Patient Check-in window appears. 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 import the patient check-in data to automatically complete the check-in fields. a. Click Import. The Import Patient Data screen appears.
PillCam Capsule Endoscopy 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. 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.
Preparing for PillCam Capsule Endoscopy g. In Capsule Type, if you have not filled in Capsule ID in the previous field, select the correct type of procedure (SB 2, SB 3, ESO 3, COLON 2). If you have filled in the Capsule ID field, this field will auto-populate with the corresponding capsule type. h. 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.
PillCam Capsule Endoscopy 10. Complete physician and insurance details: a. Enter Referring Physician and Ordering Physician. b. In Check-in by, enter your name. c. Enter Insurance, Group Number, and ICD Code, as required. d. Click Next to continue. 11. Type in the Reason for Referral, if it is known, and click Next.
Preparing for PillCam Capsule Endoscopy 12. Complete the patient physical description (Height, Weight, Waist, and Physique). 13. Click Next. 14. Complete the protocol and materials details: a. Fill in Protocol number or Name if you are performing a clinical trial. b. For Capsule lot number, enter the LOT # from the back of the capsule box. c. For Sensor serial number, enter the SN from the sensor array cable. d. For Battery pack serial number, enter the DR2 recorder battery pack serial number. e.
PillCam Capsule Endoscopy 15. In the Procedure Information Confirmation screen, verify that the patient and procedure data is correct: • If the data is incorrect, click Back and return to a previous screen to correct the mistake. • If the data is correct, select Accept, and then click Finish to continue. When the Patient Check-in complete screen appears, click Ready to proceed. ֠ Note When the patient check-in is complete, the capsule LED on the PillCam recorder lights up in orange.
Preparing for PillCam Capsule Endoscopy 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 or 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.
PillCam Capsule Endoscopy 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.
Preparing for PillCam Capsule Endoscopy 5. 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. 6. To attach each sensor, remove the protective backing from its adhesive sleeve. ֠ Note Since the sensors are placed on the body according to anatomical reference points, the distances between sensors may vary from patient to patient.
PillCam Capsule Endoscopy ESO/UGI Sensor Locations PillCam recorder DR3 54 PillCam recorder DR2 Sensor Label Sensor Color Sensor Location A B Black Yellow Upper Sternum (on the bone) Xiphoid process C Brown Intersection of left 7th intercostal space and left mid-clavicular line Fitting Equipment on the Patient
Preparing for PillCam Capsule Endoscopy SB Sensor Locations For DR3: For DR2: Standard Sensor Location Guide Fitting Equipment on the Patient Pediatric Sensor Location Guide 55
PillCam Capsule Endoscopy Sensor Label Sensor Color Sensor Location A Black B C Yellow Brown Intersection of right 7th intercostal space and right mid-clavicular line Xiphoid process D E F G H Blue Purple White Green Red Intersection of left 7th 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 56 Sensor Label Sensor Colo
Preparing for PillCam Capsule Endoscopy ֠ 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. ! Caution • Make sure that there is no other PillCam capsule or other diagnostic capsule in the patient’s gastrointestinal tract.
PillCam Capsule Endoscopy PillCam Recorder Belt ֠ Note There are three belt configurations (PillCam recorder DR2 only): • the standard recorder belt for patients over 85 lbs (40 kg), • the small recorder belt for patients under 85 lbs (40 kg), • the standard recorder belt with the belt extension for very large patients. 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.
Preparing for PillCam Capsule Endoscopy 3. Insert the PillCam recorder into its pouch. Instruct the patient to keep wearing the PillCam recorder during the examination. DR2 The pouch or belt is ready and the patient can wear it. ! DR3 Warning When a PillCam recorder is connected to a sensor array worn by a patient: • Do not connect the PillCam recorder to a computer that is connected to an electrical outlet. • Do not put the PillCam recorder into a cradle or connect it to a charger.
PillCam Capsule Endoscopy 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 it around the patient’s waist, while the patient is standing. ֠ 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. 3.
Preparing for PillCam Capsule Endoscopy ֠ Note • Remind the patient about wearing and handling the PillCam recorder with care (see General Patient Guidelines During the Procedure on page 42). • Make sure the patient has the printed instructions (see Printing the Patient Instructions on page 190). • 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.
PillCam Capsule Endoscopy 62 Fitting Equipment on the Patient
Chapter 5 Know Your PillCam Recorder Preparing the PillCam Recorder The PillCam recorder is used to receive and store the captured images from the PillCam capsule during the capsule endoscopy procedure for subsequent download to RAPID. The video created from the downloaded data can then be reviewed by the physician. There are two PillCam recorder models: DR3 and DR2.
PillCam Capsule Endoscopy 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 187.
Know Your PillCam Recorder 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 Cradle The PillCam recorder DR3 is automatically ON when it is in its cradle. When removed from the cradle, it may be turned off and on again using the On/Off button.
PillCam Capsule Endoscopy 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.
Know Your PillCam Recorder The PillCam recorder is ready for operation when: • the battery is at least 80% charged (eight or more bars displayed on battery icon), • it has been removed from the cradle, • it is connected to the sensor belt or sensor array. ! Warning 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.
PillCam Capsule Endoscopy To activate real-time viewing (only after pairing), use the navigation buttons located under the icons at the bottom of the display: press the button below the camera icon, then the left button, and then the right 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.
Know Your PillCam Recorder 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 pairing process (see PillCam Recorder—Capsule Pairing (DR3 only) on page 80) 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.
PillCam Capsule Endoscopy 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.
Know Your PillCam Recorder LEDs PillCam Recorder DR3 Status PillCam recorder DR3 has stopped receiving capsule signals for more than 5 seconds. Blinks in yellow/orange every 5 seconds PillCam recorder DR3 has stopped recording because the memory card is full. General Indications Constant on in white with error message There is an instruction on the PillCam recorder DR3 screen. Blinking in green PillCam recorder DR3 is malfunctioning.
PillCam Capsule Endoscopy Icon Explanation Icon Explanation Data has not downloaded. PillCam recorder DR3 is waiting for check-in. Data has downloaded. Indicates that AFR mode was activated in the capsule (PillCam SB 3 or COLON 2), after the PillCam recorder DR3 detected gastric passage. End of procedure. In Real-Time Viewing mode, an End of Procedure notification appears on the top right corner of the screen.
Know Your PillCam Recorder Error Messages During operation, the following messages may appear in the PillCam recorder main screen. Popup PillCam Recorder DR3 Explanation Popup Explanation No approved memory card is detected. Verify you are using an approved card. Do not remove the PillCam recorder DR3 from the cradle. Memory card is writeprotected. Sensor hardware failure. Consult a technician. Memory card error. Remove and reinsert card. Wrong sensor type. Insufficient memory on card.
PillCam Capsule Endoscopy PillCam Recorder DR2 General The PillCam recorder DR2 battery is limited to 350 use cycles. Contact customer service for a replacement battery when necessary. ֠ 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.
Know Your PillCam Recorder Charging The cradle provided with the PillCam recorder DR2: • Charges the PillCam recorder when it is placed in the cradle • Charges a spare battery externally when a stand-alone battery is placed in the cradle • 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.
PillCam Capsule Endoscopy 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 PillCam recorder is ON but not initialized. PillCam recorder does not capture capsule signals. PillCam recorder is initialized with patient data and ready to capture capsule signals.
Know Your PillCam Recorder 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 downloading data from the recorder after the procedure: to create a video or copy the video data from the recorder to the computer.
PillCam Capsule Endoscopy 78 Connecting a PillCam Recorder to the External Real-Time Viewer
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 after ingestion. 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.
PillCam Capsule Endoscopy PillCam Recorder—Capsule Pairing (DR3 only) 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.
Performing PillCam Capsule Endoscopy ֠ Note Capsule designation during patient check-in is the recommended method for 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: • if designation was not performed during check-in, or • if designation was performed, but the designated capsule is not available for the procedure.
PillCam Capsule Endoscopy The Pairing success icon ֠ Note • If a PillCam COLON 2 capsule blinks slower than 1 blink per second during the pairing procedure, return it to its box so that it stops blinking and start over. • ֠ will appear in the top right corner of the screen. 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.
Performing PillCam Capsule Endoscopy PillCam Recorder DR3 1. Make sure that the capsule and the capsule LED with each other. 2. Check the color of the capsule LED on the PillCam recorder: on the PillCam recorder are blinking in time • If (blue), go to step 3. • If (white), pair the capsule with the PillCam recorder and verify the pairing success icon appears in the top right corner of the PillCam recorder screen and the capsule LED blinks blue ֠ .
PillCam Capsule Endoscopy After Capsule Ingestion PillCam ESO/UGI The patient must stay at the medical facility until the end of the procedure (approximately 90 minutes after ingestion of the capsule). The procedure ends when the End of Procedure screen appears on the PillCam recorder. The PillCam recorder also beeps and vibrates when the End of Procedure alert appears.
Performing PillCam Capsule Endoscopy In COLON capsule procedures, the appearance of the End of Procedure icon depends on how much time has passed without paired capsule reception in the PillCam recorder DR3: • During the first 5 hours of the procedure, 25 minutes of no paired capsule reception. • Between 5 hours and 10 hours of the procedure, decreasing incrementally from 25 minutes to 10 minutes of no paired capsule reception.
PillCam Capsule Endoscopy In procedures with AFR mode capsules (PillCam SB 3 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 to AFR .
Performing PillCam Capsule Endoscopy When in Real-Time viewing the PillCam recorder screen turns off and returns to the main screen after: • 2 minutes of inactivity for colon visualization procedures/SB procedures, • 30 minutes of inactivity for ESO/UGI procedures.
PillCam Capsule Endoscopy 88 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.
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 Recorder Download. The Procedures screen appears with the Recorders tab on top. 3.
Creating RAPID Videos 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 195). During video creation, in the PillCam recorders window, the Create Video button becomes the End video creation button. The Recorder bar displays the following: • The status and progress bar. • The patient name and ID. • The name of the video to be created. • The battery status.
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.
Creating RAPID Videos 3. Under Video Data Management, Disable video data management is selected by default. Select either Copy raw data or Compile raw data. 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 92). Copying Data from a PillCam Recorder To copy video data from a PillCam recorder: 1. Place the PillCam recorder in the cradle.
PillCam Capsule Endoscopy 4. Click Manage Video Data. 5. Select the location for the copied data. 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 174. 6. Click Start Copy. During raw data copy the Recorder bar displays: • The Compiling raw data or Copying data message, depending on the video settings.
Creating RAPID Videos 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 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.
PillCam Capsule Endoscopy Batch Data Copy The 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.
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.
PillCam Capsule Endoscopy The image below displays the Study Manager layout, divided into the following sections: • Archives • Studies • Status Bar • Action buttons • Search Archives Search Studies Action buttons Status bar 98 Loading a Study with the Study Manager
Reviewing and Interpreting RAPID Videos Archives The Archives 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: An archive on a fixed drive, such as the computer's hard disk or a drive on the network.
PillCam Capsule Endoscopy • 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. ֠ Note During archive scanning, studies that already appear in the Study Manager screen can be opened.
Reviewing and Interpreting RAPID Videos Study Columns By default, the studies are sorted by the last modified study, the Video Created column. The column that is sorting is represented by an arrow. In the example below the studies are sorted by Video Created, the date that the video was created. The studies are identified by several parameters that define the study, such as patient name, capsule procedure type, and referring physician.
PillCam Capsule Endoscopy Action Buttons 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 99).
Reviewing and Interpreting RAPID Videos 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: • Text: Search by entering part of the name or the entire name of the patient, findings, procedure, or other free text. • Capsule Type: Filter the search by selecting from the drop-down list the type of capsule procedure.
PillCam Capsule Endoscopy Additionally, if opening, deleting, or exporting the study, the finding will remain highlighted to allow for its selection as shown below: 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 is displayed in the Study Manager. Managing Columns You can determine what information is displayed about each study.
Reviewing and Interpreting RAPID Videos 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 3. or .
PillCam Capsule Endoscopy 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 ֠ 106 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.
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 open: • 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.
PillCam Capsule Endoscopy Burning 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: • No multi session disc burning: once a disc is burned, you can not add any other data to it. • 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 197. To save a study to a disc: 1. 2. Insert a blank CD/DVD in the drive.
Reviewing and Interpreting RAPID Videos 6. Click Next. 7. Select Specific location under Select destination and click Next. The following screen appears. 8. Browse for the CD/DVD drive on your computer. 9. Type in a volume name for your disc. 10. Click Save. 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. 11. Click OK. RAPID will eject the CD or DVD when the burning operation is complete.
PillCam Capsule Endoscopy 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 Manager treats it as an archive and the icon ֠ 1. appears on the left side of the screen.
Reviewing and Interpreting RAPID Videos 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. Click the icon 2. Click Eject. 3. When the message that you can safely remove the hardware appears, unplug the USB storage device. on the left side of the screen to select the USB storage device.
PillCam Capsule Endoscopy 3. If you wish to delete specific files, select them and click Delete. 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 for confirmation of the deletion. ֠ Note Deleting a study in the Study Manager deletes all data including procedure videos from the source directory.
Reviewing and Interpreting RAPID Videos 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: 1. Find the study in the Offline Studies list. 2.
PillCam Capsule Endoscopy Overview of the RAPID Interface In the RAPID v8.3 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.
Reviewing and Interpreting RAPID Videos 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 Closes the current study and returns to the Home screen. Browses to open a new video. Opens the Study Manager. Saves the Findings. Opens the Atlas. Goes to the previous image. Goes to the next image.
PillCam Capsule Endoscopy File View The File menu contains several commands that enable you 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 Menu command Clicking the Open button launches the Windows screen to browse and open a video.
Reviewing and Interpreting RAPID Videos Button Menu command Secondary commands Hover over the button to display secondary commands. User Dictionary Export Import Additional Tools Delete Videos Import RAPID 4 Reports Click the Help button to load the RAPID Online Help. Hover over the button to display secondary commands.
PillCam Capsule Endoscopy • Display Progress Indicator to show viewing progress of the small bowel Quick Access Toolbar Localization Information about the open study Progress indicator Video image Video play Thumbnails buttons View Ribbon The View ribbon is divided into several groups enabling many different functions.
Reviewing and Interpreting RAPID Videos Preview Group buttons Button 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).
PillCam Capsule Endoscopy Review Group Buttons Button Function Standard Review mode: This button sets the standard review mode for PillCam SB 3 (AFR), PillCam COLON 2, PillCam ESO 2, and PillCam ESO 3/UGI 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 show the Amode (Automatic) video created for all PillCam SB 2 as well as for all PillCam SB 3 with PillCam recorder DR2 procedure videos.
Reviewing and Interpreting RAPID Videos 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. The time indicator shows the time for the top left image in the display. 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.
PillCam Capsule Endoscopy Button Action No image adjustment. FICE 1, FICE 2, or FICE 3. FICE viewing tool aids the reader in observing tissue surface characteristics and vascularity and by visually enhancing suspected structures. All FICE settings are available when viewing SB videos; only FICE 1 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.
Reviewing and Interpreting RAPID Videos 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. 2. If you wish to adjust the image otherwise, click 3. Select any of the active buttons FICE 1, FICE 2, FICE 3 or Blue for these preset image adjusters. 4. To adjust the image yourself, click 5. The "On" state means that image adjustment is applied to the image.
PillCam Capsule Endoscopy Zoom Group This ribbon group contains the controls for displaying the video image at different zoom levels. Button Function Fits the image size to the window. Changes the zoom of the video view by sliding left or right and displays the current zoom in percentage. Show Group This ribbon group enables the display or hiding of video viewing features.
Reviewing and Interpreting RAPID Videos 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 screen. 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.
PillCam Capsule Endoscopy • The QuickView by no means replaces a thorough viewing of the entire video by a qualified physician. • Using the mouse scroll wheel in this mode also displays each frame of this mode one by one.
Reviewing and Interpreting RAPID Videos • • • View the last image or first image of the video by using and . Clicking and holding the slider on the time bar and dragging it to move the video forwards or backwards. Clicking the time bar moves the video image to that specific location. ֠ 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.
PillCam Capsule Endoscopy • The Dynamic Player Control includes a Turbo Mode function which allows speeding up viewing a segment of the video. To view the video in Turbo Mode, while the video is playing, click and hold the mouse button. The playing speed accelerates and the rectangle changes to orange. • The orientation indicator appears briefly above the backward/forward arrows to show the viewing direction when you switch between the backward or forward arrows.
Reviewing and Interpreting RAPID Videos When typing thumbnail comments in PillCam ESO/UGI 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. SBI View 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.
PillCam Capsule Endoscopy displayed in a small window, with the time indication of that image at the top. If the video is in dual head view (ESO/UGI, COLON), two images appear, one for each head. • You can move the video display to a certain location by clicking that location on the color bar. • SBI indicators (small red ticks) appear in the top part of the Time bar/Color bar (see SBI View on page 129). The area before the landmarked first duodenal image is gray.
Reviewing and Interpreting RAPID Videos 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.
PillCam Capsule Endoscopy Thumbnail Description 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. Mouse-over a thumbnail without effects gives it a light blue background. Also, a checkbox becomes available in the top left corner for selecting the thumbnail for the report, as well as the edit button in the top right corner.
Reviewing and Interpreting RAPID Videos • a. Type a part of a word anywhere during text editing on the screen. b. The dictionary is context sensitive and shows 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 it in the GI Dictionary. d.
PillCam Capsule Endoscopy Thumbnail Editor Clicking the edit button in the top right corner of a thumbnail loads the Thumbnail Editor. Buttons on the left of the thumbnail editor are tools to affect markings on the thumbnail (see Markings Buttons Group on page 152) that also appear in the ribbon of the Report screen. At the bottom, you can type your comments into the Comment box. Alternatively, use the comments editor to type your comments for the thumbnail.
Reviewing and Interpreting RAPID Videos 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 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.
PillCam Capsule Endoscopy 2. Select the Video tab and in the Research Tools section, click the checkbox next to Enable Polyp Size Estimation. 3. Click Apply or OK. To use Polyp Size Estimation 1. Click 2. Place cursor at one end of a polyp. 3. 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. 4. The size estimate appears at the end where you release the mouse button.
Reviewing and Interpreting RAPID Videos Using Localization and Landmarks Landmarks Landmarking an image labels it as one of the anatomical landmarks along the GI tract.
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 is inactive and grayed 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.
Reviewing and Interpreting RAPID Videos • • 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: Section of GI tract Color Explanation Gastric Blue Indicates the stomach. The entrance to the stomach is marked by a blue dot. Small bowel Orange Indicates the small bowel.
PillCam Capsule Endoscopy 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 You can move the video display to a certain location by clicking that location on the Progress Indicator.
Reviewing and Interpreting RAPID Videos 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.
PillCam Capsule Endoscopy 3. Use the Image Adjustment tools at the top of the window of one of the thumbnails to compare the two images. . ֠ 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: 142 1. Click the first thumbnail you wish to use for comparison. 2. Hold down the CTRL key on your keyboard and select the second thumbnail. 3.
Reviewing and Interpreting RAPID Videos ֠ Note • You can scroll through the video by moving your mouse wheel in either direction, for each thumbnail separately. • If other applications on your computer use keyboard shortcuts, they may be activated when you use the shortcuts in RAPID. RAPID Video Files A RAPID study is 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 *.
PillCam Capsule Endoscopy 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. ֠ Note Save the findings frequently to avoid accidental loss of data. To save findings in new location: 1. Select File > Save > Save Findings As. The Save Findings As screen appears. 2.
Reviewing and Interpreting RAPID Videos Opening a Findings File ֠ 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.
PillCam Capsule Endoscopy Creating a PillCam Capsule Endoscopy Report 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.
Reviewing and Interpreting RAPID Videos Report Ribbon The Report ribbon is divided into several groups enabling many different functions.
PillCam Capsule Endoscopy Other Commands in the Configure Buttons Group Button Function Select all thumbnails for inclusion in the capsule endoscopy report or when saving clips and images. Unselect all thumbnails to exclude them from the capsule endoscopy report or when saving clips and images. 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.
Reviewing and Interpreting RAPID Videos Configure Dialog Box Allows defining thumbnail settings. When using the FICE or Blue Mode options when viewing thumbnails, you can include a “normal” thumbnail image alongside the FICE/Blue thumbnail when creating a report. To include a normal image alongside the FICE or Blue thumbnail in the Report: 1. From the Report screen, click the dialog box launcher ( ) of the Configure ribbon group. The following screen appears: 2.
PillCam Capsule Endoscopy Button Save As Function Save the report in the user selected location with the selected name. Use only alphanumeric characters in the file name. Make sure there are no spaces at the beginning or end of the file name. If spaces are included, the Save option will be grayed out. Send a copy of the capsule endoscopy report in an email message as an attachment, using your default email program.
Reviewing and Interpreting RAPID Videos 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. If the Export to directory is left unchecked, a screen prompting to select a location to export will be displayed each time you export.
PillCam Capsule Endoscopy 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 134) for complete instructions on marking thumbnails.
Reviewing and Interpreting RAPID Videos 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.
PillCam Capsule Endoscopy • Report screen: Click the ֠ button on the Report ribbon. Note You can activate the RAPID Atlas regardless of whether or not a video is open. If 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 you to scroll to the rest of the images.
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. 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.
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 return to the Report screen Selected thumbnail Current tertile Current tertile The tool is used for calculating the Lewis Score and is enabled only when all of the following conditions are met: • The video is a PillCam SB video. • Thumbnail images of the small bowel have been created.
Reviewing and Interpreting RAPID Videos • Length of segment for Longitudinal extent • Correct Distribution 4. Under Ulcers, select the: • Appropriate Number • Length of segment for Longitudinal extent • Correct range for Circumferential extent 5. Select the next tertile and repeat. 6. Under Stenosis, select: • The appropriate Number • Yes or No for Ulcerations • Yes or No for Traversed The Lewis Score at the top of the screen updates automatically.
PillCam Capsule Endoscopy Generating a Report 1. Click on the checkbox on the top left of the thumbnail to include it in the report. • To unselect the thumbnail, click the checkbox again. • Optionally, use the Select Current Thumbnail button to select or unselect the thumbnail. • To select all the images, click Select All Thumbnails • To unselect all images, click Unselect All Thumbnails ֠ button. button.
Reviewing and Interpreting RAPID Videos 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 is used to generate the below layout.
PillCam Capsule Endoscopy Button 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 Creates (a) jpeg(s) of the selected thumbnail(s) and saves to a folder.
Reviewing and Interpreting RAPID Videos Button Function Save Video Segment 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. Save Joined Segments Joins RAPID video segments created from selected thumbnails. Video can only be viewed with RAPID software.
PillCam Capsule Endoscopy 162 Generating a Report
Appendix A1 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. ֠ Note • You may use a Given approved power strip.
PillCam Capsule Endoscopy • • The registration window will open during the first time RAPID is opened and not at the end of the installation process. It is highly recommended to install anti-virus software on the computer running RAPID. ֠ Note At the end of the RAPID installation process, restart your computer.
Installing RAPID Software Connecting the PillCam Recorder Cradle You can connect the cradle only to the USB 2.0 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. ֠ Note If you use more than one cradle, make sure each one is connected to a different power outlet.
PillCam Capsule Endoscopy 3. 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 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: ֠ 4. Note Keep the registration window open until you finish the registration.
Installing RAPID Software • Your customer ID 6. Enter the Registration Key received from the Given Imaging registration center using ONLY lower case letters and numbers. 7. Click OK. ֠ 8. 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 performing registration.
PillCam Capsule Endoscopy 168 Starting RAPID for the First Time
Appendix A2 Configuring RAPID Software Single or Multi-user Setting When RAPID is 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 > Settings. The Settings screen appears. 2.
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 Before you can start using the PillCam Capsule Endoscopy System, you should configure the settings in RAPID.
Configuring RAPID Software General Tab From the Home screen, select Tools > Settings. 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.
PillCam Capsule Endoscopy 3. If more than one physician uses this installation of RAPID, select Clear physician name when 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.
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 > Settings. The Settings screen appears. 2.
PillCam Capsule Endoscopy 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. From the Home screen, select Tools > Settings. 2. Select the Video tab. 3. In Video Creation, under Creation method select either Create video directly from recorder or First copy raw data, then create video. ֠ 4.
Configuring RAPID Software Research Tools Section To enable video research tools: 1. From the Home screen, select Tools > Settings. 2. Select the Video tab. 3. Under Research Tools, select: • Enable FICE Viewing (for SB, ESO 3/UGI and COLON 2 videos only) • Enable Polyp Size Estimation (for COLON 2 videos only) • Enable Collage Viewing (for COLON 2 videos only) • Enable Reviewer Alert (for COLON 2 videos compiled with RAPID v8.
PillCam Capsule Endoscopy Report Tab From the Home screen, select Tools > 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.
Configuring RAPID Software 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 > Settings > Report tab. Select templates for Report layout Template name that will appear on Report ribbon Every template file name contains a variation of the features that determine the layout of the patient report.
PillCam Capsule Endoscopy 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. Template name will appear on Report ribbon ֠ 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 template must be selected.
Configuring RAPID Software 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 appears in your user profile (in Windows). As a result, whenever a report is saved, printed, exported or sent as an attachment by email, the following screen appears. Enter your login password and click Sign.
PillCam Capsule Endoscopy Check-in Tab From the Home screen, select Tools > 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. Configure Check-in Fields Section To add frequently used Check-in fields such as physician name and ICD Code: 1.
Configuring RAPID Software Other Tab From the Home screen, select Tools > 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 any changes. Clicking OK will accept the new settings and close the Settings screen. Study Manager Section Created user columns in the Study Manager are available for use by other users.
PillCam Capsule Endoscopy 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 event of a malfunction.
Configuring RAPID Software 2. Click the General, Video, Recorder, Capsule & 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.
PillCam Capsule Endoscopy Open a regimen by double clicking it or selecting it and clicking the Open button. Select pre-capsule ingestion or post-capsule ingestion regimens Approved Regimen ֠ Note If upgrading the RAPID software to version 8.3 all previously approved regimens will require approval again. The buttons on the bottom of the Regimen Manager screen perform the following: 184 Button Action New Creates a new regimen to add to the regimen library. Open Opens the selected regimen.
Configuring RAPID Software 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 PillCam COLON capsule endoscopy procedure.
PillCam Capsule Endoscopy 186 5. Type any other information in the Additional Instructions field that will appear on the printout for that specific regimen. 6. The regimens contain editable instructions 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. 7.
Configuring RAPID Software 8. If you 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. ֠ 9. 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 precapsule ingestion regimens.
PillCam Capsule Endoscopy The Notes field on the top right allows the typing of information for the specific regimen. It will not appear on the printout. 188 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.
Configuring RAPID Software 8. The regimens contain editable instructions 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. 9. Any other important information can be entered in the Additional Instructions box.
PillCam Capsule Endoscopy Printing the Patient Instructions You may need to print both types of Patient Instructions for the patient: • 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. • The post-capsule ingestion instructions need to be printed and handed to the patient after capsule ingestion.
Configuring RAPID Software Print in Pocket Format 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.
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.
Configuring RAPID Software 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 currently not connected to the computer is displayed.
PillCam Capsule Endoscopy 6. When the process is complete, a message appears that it was completed successfully. Click OK. To import backup Offline Studies: 194 1. In order to restore Study Manager Offline Studies, click the Windows Start button > Given Imaging > Backup and Restore Offline Studies. The following screen appears. 2. Select Import directory and click Next. 3. In the following screen click the Directory button to launch the Import directory screen. 4.
Configuring RAPID Software 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 > Tools > Import RAPID 4 Reports. The following message appears: Ensure that the selected reports belong to this study. 3. Click OK.
PillCam Capsule Endoscopy The Delete Video Folder window appears. Navigate to folder to delete. 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. Deleting Raw Data Files after Video Creation When creating videos in default mode, the RAPID software clears previous raw data files it may have copied to the computer in the video creation process.
Configuring RAPID Software 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, if needed to reorganize your archives.
PillCam Capsule Endoscopy 10. Once the progress bar has disappeared, click on the Drag-to-Disc screen to eject the disc. The following screen appears. 11. 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. Insert disc into disc drive. 2. Double click the DirectCD icon on the desktop. 3. In the DirectCD screen, click Format. The Format screen appears. 4.
Configuring RAPID Software Keyboard Shortcuts Key Operation Space Play/Pause Video Left arrow Go to next image Right arrow Go to previous image Page-Down Go 10 images forward Page-Up Go 10 images backwards Home Go to first image End Go to last image Enter Capture Thumbnail Control + T Show Atlas Control + M Show Study Manager Control + N Open Video Control + S Save Findings Control + O Open Findings Control + R Report Preview Control + P Report Print Control + I Image Enhan
PillCam Capsule Endoscopy 200 Keyboard Shortcuts
Appendix A3 PillCam Equipment Maintenance PillCam Recorder Maintenance Use only a fully charged (eight or more bars displayed on the battery icon) PillCam recorder. In general, including first-time use, charging the PillCam recorder is 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 is lit, and leave it in its cradle.
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 harmful interference to radio communications.
PillCam Equipment Maintenance PillCam Recorder DR2 Charging Adaptor with battery Green, orange, and red LEDs Make sure the PillCam recorder is at least 80% charged (eight or more battery bars displayed on the battery icon) for SB and COLON procedures, and at least 50% charged (five or more bars displayed on the battery icon) for ESO procedures. The cradle has the following LEDs: LED Status Battery pack is...
PillCam Capsule Endoscopy 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 is an overnight process that may take up to 12 hours. We recommend that you manually discharge the battery every three months, even if it is not used.
PillCam Equipment Maintenance PillCam Sensor Cleaning This section includes instructions for cleaning the PillCam equipment. ֠ Note To clean the PillCam equipment surfaces, we recommend using alcohol wipes (up to 70%). Usage of other classes of disinfectants (Aldehydes, Oxidizing Agents, Quaternary Ammonium, Chlorine compounds, Iodophor, Phenolic compounds) may stain or damage the materials.
PillCam Capsule Endoscopy 206 PillCam Sensor Cleaning
Appendix A4 Troubleshooting 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 COLON 2 video using RAPID v7.
PillCam Capsule Endoscopy Problem Cannot locate findings Study cannot be selected in Study Manager Cannot open a video from an archive in Study Manager and an error message requests user to click the refresh button Cause • Findings were not saved under patient’s folder • Findings were saved with the wrong name Changing an archive location that appears in the Study Manager screen, the archive remains on the archives list but its study cannot be selected Archive privileges set with no access to read or wr
Troubleshooting Sensor Belt Problem Connector is damaged Insulation of the sensor wire is damaged Cause • Mishandling the sensor belt • End of Life Action Cause Capsule failure Action 1 Send capsule to Given Imaging Ltd. 2 Open another capsule. 3 If second capsule from 10pack is DOA, contact Customer Support.
PillCam Capsule Endoscopy Problem Cannot initialize PillCam recorder DR3 No communication between the PillCam recorder and RAPID software Cause Wrong recorder bar is selected Recorder not inserted into cradle properly Action Select correct recorder bar • • Clean the contacts with alcohol wipes Firmly insert the recorder into the cradle PillCam Recorder DR2 Problem Cannot initialize PillCam recorder DR2 Cannot create video Capsule LED (right) does not blink in blue when capsule is activated (LED is or
Troubleshooting Problem Cancelling Data Copy displays error message that Video Copy was unsuccessful Cause Cancelling the Data Copy in mid-sequence triggers Video Copy message Action Error Messages Message Full name not defined for this user. Please 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.
PillCam Capsule Endoscopy Low Signal If a low signal is detected during the examination, the following message appears. A low signal detected during the examination may be due to: • Improper use of the sensor array/sensor belt • A defective sensor array/sensor belt • A PillCam recorder malfunction If this message is displayed, Contact Customer Support. Click OK to close the message.
Appendix A5 Technical Description System Labeling The following table lists the labels attached to various components of the PillCam Capsule Endoscopy System. Labeling Explanation PillCam capsules are MR unsafe. 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.
PillCam Capsule Endoscopy Capsule Labeling Each box has a label at the bottom as shown below. Each capsule is marked with the expiration date, lot number, and a unique capsule ID code. Capsule ID Code Expiration Date 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.
Technical Description Warnings • PillCam video capsules and PillCam recorder may be interfered with by other equipment, even if that other equipment complies with CISPR emission requirements. • 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.
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 Ltd. as replacement parts for internal PillCam recorder components, may result in increased emissions or decreased immunity of the PillCam Capsule Endoscopy System.
Technical Description System Specifications ֠ Note • Specifications are subject to change without prior notice and without any obligation to users on the part of the manufacturer. • Specifications are rounded to the appropriate decimal place. PillCam SB 2 Capsule Properties Physical Optical Operational System Specifications Dimensions Length: 26.3 mm Diameter: 11.4 mm Weight 2.
PillCam Capsule Endoscopy PillCam SB 3 Capsule Properties Physical Optical Operational Downlink communication 218 Dimensions Weight Length: 26.2 mm Diameter: 11.4 mm 3.0 g Material Biocompatible plastic Illumination 4 white light emitting diodes # of imaging heads 1 Field of view 156° ISO-8600-3 Effective visibility Min. detectable object 156° (Optical field of view at 4.5 mm from top cover per ISO-8600-3) 136° (Optical field of view from entrance pupil per FDA Method) At least 0.
Technical Description PillCam UGI Capsule Properties Physical Dimensions Length: 32.3 mm+0.5 mm Diameter: 11.6 mm Optical Operational System Specifications Weight 2.9 g + 0.1 g Material Biocompatible plastic Illumination 4 white light emitting diodes on each side # of optical heads 2 Field of view 172° ISO-8600-3 Effective visibility Distance: 3 cm Min. detectable object At least 0.1 mm Frequency 434.1 MHz Band width 9.
PillCam Capsule Endoscopy PillCam COLON 2 Capsule Properties Physical Optical Operational Uplink communication Downlink communication 220 Dimensions Weight Length: 32.3 mm+0.5 mm Diameter: 11.6 mm 2.9 g + 0.1 g Material Biocompatible plastic # of optical heads 2 Illumination 4 white light emitting diodes on each side Field of view 172° ISO-8600-3 Effective visibility Distance: 3 cm Min. detectable object At least 0.
Technical Description Sensor Array PillCam Recorder DR2 Versions: SB, COLON, ESO Reception antenna Sensor size Diameter 40 mm Color Black Material Plastic SB = COLON sensor array ESO sensor array 8 sensor elements 3 sensor elements Sensor Array PillCam Recorder DR3 Properties Reception antenna Transmission antenna System Specifications # of sensor elements 3 or 8 sensors Sensor size Diameter: 40 mm Color Black Material Polyurethane, Teflon Antennas wire material Coax wire Antenna struc
PillCam Capsule Endoscopy PillCam Recorder DR2/DR2C Properties Physical Software Proprietary firmware Recording capacity PillCam recorder DR2: @ 2fps for 10 hours PillCam recorder DR2C: @ 4fps for 10 hours Weight 500 g, including battery pack Operational Power 6–10 V DC, 100–250 mA Battery type Internal, Li-Ion, 7.2 V, 4400 mAH Battery Pack weight 200 g Operating temp. 0–40°C Storage temp.
Technical Description PillCam Recorder DR3 Properties Physical Receiver (Rx) Transmitter System Specifications Software Proprietary firmware Recording capacity Up to 15 hours @ LCD OFF Weight 500 g, including battery pack Operational Power 3.5–4.2 V DC, 0.15–0.5 A Battery type Internal, Li-Ion, 3.8 V typical, 8800 mAH Operating temp. 0–40°C Storage temp. 0–55°C Storage and Operating humidity Up to 85% Storage and Operating pressure 790–520 mmHg Operating frequency 434.
PillCam Capsule Endoscopy PillCam Recorder DR3 SDHC Memory Card Properties Dimensions 24 mm x 32 mm x 2 mm Weight 2.
Technical Description 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 proprietary) 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 Vi
PillCam Capsule Endoscopy Guidance and manufacturer’s declaration - electronic immunity The PillCam 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.
Technical Description Guidance and manufacturer’s declaration - electronic immunity The PillCam 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.
PillCam Capsule Endoscopy 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.
Technical Description PillCam Recorder DR2/DR2C 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. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 The PillCam recorder DR2 uses RF energy only for its internal function.
PillCam Capsule Endoscopy Guidance and manufacturer’s declaration - electronic immunity Voltage dips, short interruptions and voltage variations on power supply input lines <5% UT (>95% dip in UT) for 0.5 cycle <5% UT (>95% dip in UT) for 0.
Technical Description Guidance and manufacturer’s declaration - electronic immunity Note 1: Note 2: Note 3: Note 4: Note 5: At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 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).
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. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 The PillCam recorder DR3 uses RF energy only for its internal function.
Technical Description Guidance and manufacturer’s declaration - electromagnetic immunity for all equipment and systems Voltage dips, short interruptions and voltage variations on power supply input lines <5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles N/A Mains power quality should be that of a typical commercial or hospital environment.
PillCam Capsule Endoscopy 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.
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.
PillCam Capsule Endoscopy 236 Guidance and Manufacturer's Declarations
Index A abdominal pain ............................................ 37 Acknowledge button .................................... 68 action buttons, Study Manager .................... 102 adaptive frame rate (AFR) ............................ 30 adhesive sleeve ............................................ 52 AFR mode ......................... 69, 86, 120, 139 archive, add ................................................. 99 Archives ..................................................... 99 archives, options ...
Image Adjustment ............................. 121, 123 image data, restore ....................................... 31 image data, transmission ............................... 31 image date, receive ....................................... 31 Indications for Use ......................................... 3 Initialization ................................................ 63 L landmark, create ......................................... 137 Landmarks ........................................ 130, 137 laxative .....
ribbon tabs ................................................ 114 S X X-ray .......................................................... 37 SB Sensor Locations .................................... 55 SBI View .................................................. 129 SD card ....................................................... 64 search, Study Manager ............................... 103 Sensor array troubleshooting .................................... 208 sensor array .........................................
240 Index
