PillCam Capsule Endoscopy Desktop User Manual Ver 8.3 Feb 2015

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. All other company or product names are the trademarks or registered trademarks of their respective holders. All rights not expressly granted are reserved. This device complies with Part 15 of the FCC rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

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Note Changes or modifications not expressly approved by Given Imaging Limited could void authority to operate the PillCam Capsule Endoscopy System.

Rx Only

Given Imaging 3950 Shackleford Road, Suite 500 Duluth GA 30096 USA [email protected] Given Imaging GmbH Borsteler Chaussee 47 D-22453 Hamburg, Germany [email protected]

Table of Contents Chapter 1

Using This Guide ... 1 Conventions ... 1 Chapter 2

Indications, Contraindications, Warnings, Cautions ... 3 Indications for Use... 3 PillCam SB... 3 PillCam ESO ... 3 PillCam UGI ... 3 PillCam COLON... 4 Contraindications ... 4 PillCam SB... 4 PillCam ESO/PillCam UGI ... 4 PillCam COLON... 4 Adverse Events ... 5 Warnings... 5 Cautions... 8 Benefits and Risks-PillCam Capsule Endoscopy... 8 Benefits ... 8 Risks ... 9 Essential Performance ... 10 PillCam Video Capsules ... 10 PillCam Recorder DR2 and PillCam Recorder DR3 ... 10 Accuracy of the Device-SB... 10 Accuracy of the Device-ESO ... 12 Accuracy of the Device-UGI ... 13 Accuracy of the Device-COLON 2... 17 Clinical Validation Study and Interpretation of Results ... 17 Evaluation of Capsule Endoscopy with PillCam COLON 2 in Visualization of the Colon (MA-204) 17 Chapter 3

Welcome to PillCam Capsule Endoscopy ... 29 What is PillCam Capsule Endoscopy? ... 29 The PillCam Capsule Endoscopy Process ... 29 PillCam Capsule Endoscopy System Components... 29 PillCam Capsules... 29 Handling the PillCam Capsule ... 31 PillCam Recorders ... 31 PillCam Sensors ... 32 RAPID for PillCam Software ... 32 Home Screen ... 32

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PillCam Capsule Endoscopy Chapter 4

Preparing for PillCam Capsule Endoscopy ... 37 Preparing the Patient ... 37 Preparing the Required Equipment ... 38 Connecting the PillCam Recorder to RAPID for Check-in ... 38 Creating Patient Instructions for the Procedure ... 40 Pre-ingestion Instruction Handouts ... 40 Post-ingestion Instructions for Procedures Involving Colon Visualization ... 41 General Patient Guidelines During the Procedure ... 42 Performing Patient Check-in ... 43 Updating Patient Details ... 50 Fitting Equipment on the Patient ... 51 Applying the PillCam Sensor Belt ... 51 Applying the PillCam Sensor Array ... 52 Necessary Equipment and Accessories... 52 ESO/UGI Sensor Locations ... 54 SB Sensor Locations... 55 COLON 2 Sensor Locations... 56

Attaching the Sensors to the PillCam Recorder ... 57 Recorder Pouch ... 57 PillCam Recorder Belt... 58 PillCam Recorder DR2 and DR3... 58 Positioning PillCam Recorder DR3 ... 59 Positioning PillCam Recorder DR2 ... 60 Chapter 5

Know Your PillCam Recorder ... 63 Preparing the PillCam Recorder ... 63 Functions ... 63 Initialization... 63 Pairing for DR3 ... 63 Real-Time Viewing ... 63 Regimen Reminder... 64 Download... 64 PillCam Recorder DR3 ... 64 General... 64 Turning On and Off... 65 Regimen Reminder... 66 Charging ... 66 Controls ... 67 Main Display... 67 LED Display ... 68 Acknowledge (ACK) Button, Designated for Patient Use... 68 Navigation Buttons ... 69 Button Pressing Indication ... 69 Battery and Capsule Icons ... 70 PillCam Recorder DR3 LEDs ... 70 Screen Icons ... 71 Check-in Screen Icons ... 72 ii

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Error Messages... 73

PillCam Recorder DR2... 74 General ... 74 Turning On and Off ... 74 Charging ... 75 PillCam Recorder DR2 LEDs... 75 Connecting a PillCam Recorder to a Personal Computer (PC)... 77 Connecting a PillCam Recorder to the External Real-Time Viewer ... 77 Chapter 6

Performing PillCam Capsule Endoscopy ... 79 Setting Delay First Instruction in PillCam Recorder... 79 PillCam Recorder-Capsule Pairing (DR3 only) ... 80 Capsule Designation During Patient Check-in... 80 Capsule Designation Before Capsule Ingestion ... 81 Capsule Ingestion ... 82 PillCam Recorder DR3... 83 PillCam Recorder DR2... 83 After Capsule Ingestion... 84 PillCam ESO/UGI... 84 PillCam SB... 84 PillCam Recorder DR3... 84 PillCam Recorder DR2... 84

PillCam COLON (DR3 only)... 84 Real-Time Viewing with PillCam Recorder DR3 Only-Internal Mode... 85 Real-Time Viewing with PillCam Recorder DR2 Only- External Mode ... 87 Removing Equipment from the Patient... 87 Chapter 7

Creating RAPID Videos ... 89 PillCam Recorder Download... 89 Creating a Video from the PillCam Recorder... 90 Creating a Video from USB Storage Device or DVD ... 91 Batch Video Creation ... 92 From PillCam Recorders... 92 From Raw Data Files/USB Storage Devices... 92

Pause/End Video Creation... 92 Managing RAPID Video Data ... 92 Copying Data from a PillCam Recorder... 93 Managing Data Files ... 95 Batch Data Copy... 96 From PillCam Recorders... 96 From Video Data Files/USB Storage Devices... 96

Backing up Data... 96 Table of Contents

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PillCam Capsule Endoscopy Chapter 8

Reviewing and Interpreting RAPID Videos ... 97 Loading a Study with the Study Manager ... 97 Archives... 99 Adding an Archive ... 99 Archive Options ... 100

Studies... 100 Study Columns ... 101 Study Options... 101

Understanding the Status Bar ... 101 Action Buttons ... 102 Search Function ... 103 Managing Columns... 104 Using the Study Manager ... 107 Open ... 107 Export ... 107 Burning a Study to a CD/DVD... 108 Saving a Study to Another Archive ... 110 Saving a Study as a Zip File ... 111

Delete ... 111 Offline Studies ... 112 Overview of the RAPID Interface... 114 Dialog Box Launchers ... 114 Quick Access Toolbar... 115 File View ... 116 View Screen ... 117 View Ribbon ... 118 Preview/Review Groups ... 118 Preview Group buttons ... 119 Review Group Buttons ... 120 Viewing Layout Group... 120 Image Adjustment Group ... 121 Zoom Group ... 124 Show Group ... 124

Using RAPID to View a Video ... 125 Reading a Capsule Endoscopy Video ... 125 QuickView ... 125 Complementary QuickView ... 126

Viewing a Video... 126 Dynamic Player Control... 127 Dual Head View... 128 SBI View ... 129 Time Bar/Color Bar ... 129 Time Indication ... 130

Creating and Annotating Thumbnails ... 130 Thumbnail Status ... 131 Thumbnail Comments ... 132 Thumbnail Editor ... 134 Marking Tools... 134 Mark Circle ... 134 Mark Arrow ... 135 Undo Mark ... 135 iv

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Circumference Scale ... 135 Polyp Size Estimation ... 135

Using Localization and Landmarks ... 137 Landmarks ... 137 Suggested Flexure Landmarks for COLON Videos ... 138 Suggested Landmarks for PillCam SB 3 Videos... 138 Localization ... 138 PillCam Progress Indicator... 139 Colon Location Diagram... 140 Passage Times ... 141

Comparing Thumbnails... 141 RAPID Video Files... 143 Working with Findings ... 143 Saving Your Findings... 144 Opening a Findings File ... 144 Creating a PillCam Capsule Endoscopy Report ... 146 Overview ... 146 Report Ribbon... 147 Configure Buttons Group ... 147 Report Buttons Group ... 149 Markings Buttons Group ... 152 Clinical Tools Buttons Group... 152

RAPID Atlas ... 153 Comparing Video Images to Atlas Images... 154 Atlas Image Export... 155 Lewis Score ... 155 Generating a Report ... 158 Image Data Buttons Group ... 159 Appendix A1

Installing RAPID Software ... 163 Setup Requirements ... 163 RAPID Installation... 163 Main Endoscopy System Components... 164 Connecting the Components... 164 Connecting the PillCam Recorder Cradle... 165 Starting RAPID for the First Time... 165 Appendix A2

Configuring RAPID Software ... 169 Single or Multi-user Setting ... 169 RAPID Workstation Configuration... 169 RAPID Settings... 170 General Tab ... 171 User Information Section... 171 Regional Settings Section ... 172 Permissions Section... 173

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Video Tab ... 173 Video Creation Section ... 174 Video Data Management Section ... 174 Research Tools Section ... 175

Report Tab... 176 Report Templates Section... 177 Electronic Signature ... 178 Use of the Electronic Signature... 179 Results Export and Patient Summary Sections ... 179 Regimen Format Section ... 179

Check-in Tab ... 180 Configure Check-in Fields Section ... 180 HIS Information Directory Section ... 180

Other Tab ... 181 Study Manager Section ... 181 Regimen Settings Section... 181 Customer Support Section ... 182

Regimen Manager... 183 Using the Regimen Manager... 183 Pre-Ingestion Patient Instructions... 185 Post-Ingestion Patient Instructions ... 187 Printing the Patient Instructions... 190 Print Layout of the Post-Capsule Ingestion Instructions ... 190 Print in Pocket Format... 191 Print in Page Format ... 192

Additional Settings... 192 Backup/Restore Offline Studies... 193 Importing Reports ... 195 Freeing Space on Your Computer... 195 Deleting Videos ... 195 Deleting Raw Data Files after Video Creation... 196

Backup System Logs... 196 CD/DVD Burning ... 197 Roxio Drag-to-Disc 9 ... 197 DirectCD 5... 198

Keyboard Shortcuts ... 199 Appendix A3

PillCam Equipment Maintenance ... 201 PillCam Recorder Maintenance... 201 Important Safety Instructions... 201 PillCam Recorder DR3 ... 202 PillCam Recorder DR2 ... 203 Charging... 203 Manual Discharge ... 204

PillCam Sensor Cleaning ... 205 Cleaning the PillCam Sensor Belt ... 205 Cleaning the PillCam Sensor Array ... 205 Cleaning the Recorder Pouch ... 205

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Appendix A4

Troubleshooting ... 207 RAPID Video ... 207 Saving and Opening Videos ... 207 Printer ... 208 CD/DVD ... 208 Sensor Array ... 208 Sensor Belt ... 209 Capsule ... 209 Cradle... 209 PillCam Recorder DR3... 209 PillCam Recorder DR2... 210 Error Messages ... 211 Low Signal ... 212 Appendix A5

Technical Description ... 213 System Labeling ... 213 Capsule Labeling ... 214 Essential Performance ... 214 PillCam Capsules... 214 PillCam Recorder DR2 and PillCam Recorder DR3 ... 214 Warnings... 214 Cautions... 216 System Specifications... 217 PillCam SB 2 Capsule... 217 PillCam SB 3 Capsule... 218 PillCam UGI Capsule ... 219 PillCam COLON 2 Capsule... 220 Sensor Array PillCam Recorder DR2... 221 Sensor Array PillCam Recorder DR3... 221 PillCam Recorder DR2/DR2C ... 222 Cradle PillCam Recorder DR2 ... 222 PillCam Recorder DR3 ... 223 PillCam Recorder DR3 SDHC Memory Card... 224 Cradle PillCam Recorder DR3 ... 224 DC Power Supply... 224 RAPID for PillCam Software ... 225 Guidance and Manufacturer's Declarations ... 225 PillCam Capsules... 225 PillCam Recorder DR2/DR2C ... 229 PillCam Recorder DR3 ... 232

Index ... 237

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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:

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Note When connecting more than one PillCam recorder DR2 to the computer, use a USB-powered hub.

A Caution warns you about possible damage to equipment, and appears as follows:

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Caution Make sure that there is no other PillCam capsule or other diagnostic capsule in the patient’s gastrointestinal tract.

A Warning warns you about possible harm to people and appears as follows:

!

Conventions

Warning Never connect the PillCam recorder to the sensor array while the PillCam recorder is in its cradle.

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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.

•

The PillCam Capsule Endoscopy System with the PillCam SB capsule may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.

•

The PillCam Capsule Endoscopy System with the PillCam SB capsule may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.

The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas. The PillCam Capsule Endoscopy System with PillCam SB capsules may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.

PillCam ESO The PillCam Capsule Endoscopy System with PillCam ESO capsules is intended for the visualization of esophageal mucosa in adults and children from 18 years of age.

PillCam UGI The PillCam UGI capsule endoscopy system is intended for visualization of the upper gastrointestinal tract (esophagus, stomach, duodenum). It may be used for visualization of blood in the upper gastrointestinal tract (esophagus, stomach, duodenum) in patients who are hemodynamically stable and at least 18 years of age.

Indications for Use

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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.

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Note The procedure may involve intake of laxatives and prokinetic (“push”) agents to aid in advancement of the capsule through the digestive tract. Refer to the labeling of these agents for their contraindications.

Contraindications PillCam SB The PillCam SB capsules are contraindicated for use under the following conditions: •

In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.

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In patients with cardiac pacemakers or other implanted electromedical devices.

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In patients with dysphagia or other swallowing disorders.

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Note The SB PillCam Capsule may be deployed by using transendoscopic delivery in patients who are either unable to ingest the PillCam capsule or are known to have slow gastric emptying time. Placement into the duodenum is recommended to prevent the patient from vomiting the capsule.

PillCam ESO/PillCam UGI The PillCam ESO/PillCam UGI capsule is contraindicated for use under the following conditions: •

In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or preprocedure testing and profile.

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In patients with cardiac pacemakers or other implanted electromedical devices.

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In patients with dysphagia or other swallowing disorders.

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Note This device is not meant to replace upper endoscopy.

PillCam COLON The PillCam COLON capsule is contraindicated for use under the following conditions:

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In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.

•

In patients with cardiac pacemakers or other implanted electromedical devices. Contraindications

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. In some instances, intervention is required to remove the capsule.

Warnings

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Warning PillCam capsules are MR unsafe.

Procedure Related: •

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).

•

The PillCam COLON 2 capsule may be used for individuals after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon, was not technically possible.

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A normal or negative capsule endoscopy examination does not exclude the possibility of colon polyps or colon cancer.

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A negative or normal result obtained by the PillCam video capsule does not exclude the presence of pathology and if symptoms persist, further evaluation should be performed.

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The safety of the PillCam SB capsule has not been established in children below two years of age.

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The safety of the PillCam ESO/PillCam UGI capsule has not been established in patients below age 18.

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The safety of the PillCam COLON capsule has not been established in patients below age 18.

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In a small number of cases, the PillCam COLON capsule used for Colon capsule endoscopy may not image the entire large bowel (colon) due to variations in patient GI motility. In the MA-204 study 104 (11.8%) subjects were excluded due to issues with the capsule procedure including 77 (8.7%) subjects with inadequate cleansing or short transit time for the capsule.

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If an adequate cleansing level is not achieved and the total transit time of the capsule is less than 40 minutes related, a repeat evaluation should be considered with the PillCam COLON capsule, or with alternative diagnostic modalities.

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The capsule should not be swallowed by children under the age of 8 years or patients where a concern for aspiration of the capsule exists (e.g., due to cognitive or neurological deficits or a history of aspiration). In these patients, it is recommended that a capsule endoscopic delivery

Adverse Events

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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.

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If intestinal fistulas, strictures, or stenosis are suspected, or the patient has had prior abdominal or pelvic surgery, the physician should consider performing an examination to ascertain patency for an object the size of the PillCam video capsule.

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A thorough understanding of the technical principles, clinical applications and risks associated with the PillCam system is necessary before using this product. Read the entire manual before using the system for the first time.

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To prevent the patient from being exposed to unforeseen risks during passage of any PillCam video capsule, make sure the patient thoroughly understands the procedure, and provide the patient with a copy of the Patient Instructions.

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A patient with known or suspected delayed gastric emptying (whether disease related or drug induced) could be at increased risk for incomplete PillCam capsule endoscopy of the small bowel or colon.

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When swallowing the capsule there is a possibility of choking on the capsule. If the patient exhibits any symptoms and/or clinical signs of choking (labored breathing, wheezing, involuntary coughing, etc.), the recommended first-aid procedure should be followed.

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If a child has accidentally swallowed any unused or spent PillCam video capsule, seek medical attention.

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Instruct the patient not to sit on bare metal surfaces, such as chairs with metal seating area, during the procedure.

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Instruct the patient to contact the physician immediately if, after ingesting any PillCam video capsule, there is any abdominal pain, nausea, or vomiting.

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Only one PillCam video capsule should be ingested at a time and only after confirmation that no other PillCam video capsules or ingestible diagnostic devices remain in the patient’s body.

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If, contrary to instructions, a patient ingests more than one PillCam video capsule, instruct the patient to immediately contact the physician.

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In patients with unsuspected strictures of the GI tract, any PillCam video capsule can potentially cause intestinal obstruction resulting in the need for hospitalization and surgery.

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The safety of this device in pregnant women has not been established.

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The safety of this device in patients with significant gastrointestinal diverticular disease is unknown.

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Final diagnosis based on the RAPID video should be made only by physicians who are trained in the interpretation of capsule endoscopy images.

Product Related:

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If there is reasonable doubt concerning the integrity of the PillCam video capsule due to dropping, biting, or any other eventuality, the capsule should be deactivated by returning it to its box and it should not be used until consulting with an authorized Given Imaging representative.

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Store all PillCam video capsules in a safe place, out of the reach of children and infants.

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Do not use any PillCam video capsule after its expiration date.

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Instruct the patient to avoid biting the PillCam video capsule prior to swallowing.

Warnings

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.

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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.

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Occasionally, some images may be lost (less than 3% for COLON 2 and UGI procedures and less than 1% for SB procedures) which results in video gaps (shown as a gray section on the time bar display of the RAPID video) due to radio interference (e.g., from amateur radio transmitters, RFID (radio-frequency identification) systems, MRI). This may result in the need to repeat the capsule endoscopy procedure. In such a case, advise the patient to stay within the premises of the clinic for the duration of the second capsule endoscopy procedure to prevent this problem from recurring.

Electromagnetic Compatibility Related: •

After ingesting the PillCam video capsule and until it is excreted, the patient should not be near any source of powerful electromagnetic fields such as one created near an MRI device.

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Keep the magnet of the PillCam video capsule’s packaging away from implants such as pacemakers, defibrillators, nerve stimulators, and other devices that could be affected by proximity to a DC magnetic field.

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PillCam Capsule Endoscopy System and its components need special precautions regarding Electromagnetic Compatibility (EMC) to avoid loss of image transfer resulting in video gaps. PillCam Capsule Endoscopy System needs to be installed and put into service according to the Electromagnetic Compatibility (EMC) information provided in the accompanying documents.

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The use of the accessory with PillCam capsule other than those specified may result in increased emissions or decreased immunity of the PillCam capsule.

Recorder Related:

Warnings

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A PillCam video capsule should be ingested only in the presence of authorized medical personnel. The patient should be instructed not to let relatives, neighbors or acquaintances use any PillCam video capsule without medical attention.

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If excretion of the PillCam video capsule from the patient has not been positively verified, and the patient develops unexplained post-procedure abdominal pain, vomiting, or other symptoms of obstruction, he/she should contact the physician for evaluation and possible abdominal X-ray examination.

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Never connect the PillCam recorder to the sensor array while the PillCam recorder is in its cradle.

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The PillCam video capsule and PillCam recorder should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used.

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Portable and mobile RF communications equipment can affect the PillCam video capsule and the PillCam recorder.

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The PillCam video capsule may be interfered with by other equipment, even if that other equipment complies with CISPR emission requirements.

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The Lithium-Ion battery pack in the PillCam recorder DR3 incorporates built-in safety devices.

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Do not use the PillCam recorder in a location where static electricity (greater than the manufacturer’s guarantee) may be present. Otherwise, the safety devices can be damaged, possibly leading to acid leakage, overheating, smoke emission, bursting and/or ignition. 7

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.

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Use the system only with components purchased from Given Imaging Ltd. Use of other components including power supply for the cradle, may damage the system and void the warranty.

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Occasionally, some images may be lost (less than 3% for COLON 2 and UGI procedures and less than 1% for SB procedures) which results in video gaps (shown as a gray section on the time bar display of the RAPID video) due to radio interference (e.g., from amateur radio transmitters, RFID (radiofrequency identification) systems, MRI). This may result in the need to repeat the capsule endoscopy procedure. In such a case, advise the patient to stay within the premises of the clinic for the duration of the second capsule endoscopy procedure to prevent this problem from recurring.

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In a small number of cases, the PillCam SB capsules used for Small Bowel Capsule Endoscopy may not image the entire small bowel due to variations in patient GI motility. Similarly the PillCam COLON capsule used for COLON Capsule Endoscopy may not image the entire large bowel (colon) due to variations in patient GI motility.

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Final diagnosis based on the RAPID video should be made only by physicians who are trained in the interpretation of capsule endoscopy images.

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The Lithium-Ion battery pack in the PillCam recorder DR3 incorporates built-in safety devices. Do not use the PillCam recorder in a location where static electricity (greater than the manufacturer’s guarantee) may be present. Otherwise, the safety devices can be damaged, possibly leading to acid leakage, overheating, smoke emission, bursting and/or ignition.

Benefits and Risks-PillCam Capsule Endoscopy Benefits

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PillCam capsule endoscopy is the most widely used patient-friendly tool for visualization of the GI tract. To date, more than 2,000,000 patients worldwide have benefited from PillCam endoscopy.

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PillCam capsule endoscopy provides an alternative for those patients who have had an incomplete optical colonoscopy with an adequate preparation, and a complete evaluation of the colon was not technically possible.

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After the patient swallows the PillCam video capsule, images and data are transmitted wirelessly as the capsule passes through the digestive system. The images are captured and stored in a PillCam recorder worn by the patient; after the procedure is complete the images are reviewed by a physician.

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The procedure does not require sedation, intubation, bowel insufflation or radiation.

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Patients may continue with their normal daily activity during the procedure.

Cautions

Indications, Contraindications, Warnings, Cautions •

PillCam capsule endoscopy offers a simple, safe and non-invasive alternative to traditional imaging procedures.

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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.

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PillCam capsule endoscopy is not for everyone. PillCam video capsules are contraindicated in patients with known or suspected gastrointestinal obstruction, strictures or fistulas, in patients with cardiac pacemakers or other implantable electromedical devices and in patients with swallowing disorders.

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Capsule retention has been reported in less than two percent of all capsule endoscopy and patency procedures. Capsule retention is defined as having a capsule remain in the digestive tract for more than two weeks.

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Causes of retention cited in the literature include: NSAID strictures, Crohn's disease, small bowel tumors, intestinal adhesions, ulcerations, and radiation enteritis. Summaries in published literature identify the overall risk of retention for capsule endoscopy to be 1.4%. The risk of retention for obscure bleeding is estimated to be 1.2%, for suspected Crohn's disease to be 2.6%, for known Crohn's the risk is higher at 5% and for neoplastic lesions the rate of retention is 2.1% as compared to healthy volunteers [1]. To verify passage of the capsule from the GI tract, an abdominal X-ray may be obtained at the discretion of the physician. The capsule can be removed using medical, endoscopic or surgical intervention.

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There is an extremely rare risk of capsule aspiration while patients are attempting to swallow a PillCam video capsule or Patency capsule.

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There is also a low risk of skin irritation from the sensor array sleeve adhesive or silicone exposure.

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The PillCam SB video capsule may be administered by using transendoscopic delivery in patients who are either unable to ingest the capsule or are known to have slow gastric emptying time. If using transendoscopic delivery potential complications include, but are not limited to: perforation, hemorrhage, aspiration, fever, infection, hypertension, respiratory arrest, cardiac arrhythmia or arrest, due to the transendoscopic procedure.

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PillCam patency capsules are contraindicated in patients with swallowing disorders. The PillCam patency scanner is contraindicated in patients with cardiac pacemakers or other implanted electromedical devices.

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All medical procedures carry some risks. Information on this site should not be used as a substitute for talking with your doctor about diagnosis and treatment.

References: [1] Liao et al., Indications and detection, completion, and retention rates of small-bowel capsule endoscopy: a systematic review, Gastrointestinal Endoscopy, 2010; 71:280-286

Benefits and Risks-PillCam Capsule Endoscopy

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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.

PillCam Recorder DR2 and PillCam Recorder DR3 Data receiving by PillCam recorder is considered to be essential performance of the PillCam recorder DR2 and PillCam recorder DR3.

Accuracy of the Device-SB The PillCam Capsule Endoscopy System with the PillCam SB 1 capsule was studied in a series of 20 subjects with hemoccult positive stool, iron-deficiency anemia, and/or subacute hematochezia or melena. All patients had undergone unrevealing colonoscopy, gastroscopy, enteroscopy, and small bowel X-rays prior to enrolling in the study. When compared to repeated push enteroscopy, the PillCam video capsule was able to detect a pathological abnormality in 12 (60%) of the patients whereas enteroscopy detected abnormalities in 7 (35%) of these patients. The 5 patients in whom lesions were found by the PillCam video capsule but not enteroscopy all had abnormalities in the distal jejunum or ileum, outside the reach of most standard enteroscopy examinations. The average length of insertion during enteroscopy was 2.3 meters. Specific findings detected by the imaging system included arterio-venous malformations (AVMs), mucosal erosions and ulcerations, and a submucosal tumor. In one case (5%), though the PillCam video capsule detected a small bowel AVM that was found by enteroscopy, one out of the two reviewing physicians did not detect the AVM when reviewing the RAPID video. Overall, the findings obtained from the PillCam Capsule Endoscopy System and standard enteroscopy agreed in 14 cases (70%). The two methods revealed similar pathologies in 6 of these patients. Both exams were normal in an additional 8 patients. [1] A total of 14 separate small bowel findings were eventually noted in 13 patients by either of the two imaging modalities or by laparoscopic surgery. The PillCam Capsule Endoscopy System was able to identify 12 of the 14 lesions (86%) while the enteroscopy detected 7 of the 14 lesions (50%). Both repeated enteroscopies, small bowel X-rays and the PillCam video capsule, failed to detect an ulcerated Meckel’s diverticulum found at surgery. PillCam video capsule localization is based on off-line processing of the strength of the radio frequency signals emitted from the PillCam video capsule as received by each of the eight sensors. The information helps estimate the relative two-dimensional location of the PillCam video capsule with respect to the umbilicus (e.g., abdominal quadrant).

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Essential Performance