Given Imaging CAPSH-3 PillCam Capsule Endoscopy User Manual DOC xxxx 01 PillCam RAPID 8 5 EN
Given Imaging Limited PillCam Capsule Endoscopy DOC xxxx 01 PillCam RAPID 8 5 EN
User Manual
PillCam® Capsule Endoscopy
User Manual
RAPID® v8.3
DOC-2601-02
February 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.
Rx Only
֠
֠֠
֠Note
Changes or modifications not expressly approved by Given Imaging Limited
could void authority to operate the PillCam Capsule Endoscopy System.
Given Imaging
3950 Shackleford Road, Suite 500 Duluth GA
30096 USA supportUS@givenimaging.com
Given Imaging GmbH
Borsteler Chaussee 47 D-22453
Hamburg, Germany supportEU@givenimaging.com
Table of Contents i
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
PillCam Capsule Endoscopy
ii Table of Contents
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
Table of Contents iii
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
PillCam Capsule Endoscopy
iv Table of Contents
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
Table of Contents v
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
PillCam Capsule Endoscopy
vi Table of Contents
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
Table of Contents vii
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
PillCam Capsule Endoscopy
viii Table of Contents
Conventions 1
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:
A Caution warns you about possible damage to equipment, and appears as follows:
A Warning warns you about possible harm to people 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.
!
Caution
Make sure that there is no other PillCam capsule or other diagnostic capsule
in the patient’s gastrointestinal tract.
!
Warning
Never connect the PillCam recorder to the sensor array while the PillCam
recorder is in its cradle.
PillCam Capsule Endoscopy
2 Conventions
Indications for Use 3
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.
PillCam Capsule Endoscopy
4 Contraindications
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.
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.
•In patients with cardiac pacemakers or other implanted electromedical devices.
•In patients with dysphagia or other swallowing disorders.
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.
•In patients with cardiac pacemakers or other implanted electromedical devices.
•In patients with dysphagia or other swallowing disorders.
PillCam COLON
The PillCam COLON 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 pre-procedure testing and profile.
•In patients with cardiac pacemakers or other implanted electromedical devices.
֠
֠֠
֠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.
֠
֠֠
֠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.
֠
֠֠
֠Note
This device is not meant to replace upper endoscopy.
Indications, Contraindications, Warnings, Cautions
Adverse Events 5
•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
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.
•A normal or negative capsule endoscopy examination does not exclude the possibility of colon
polyps or colon cancer.
•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.
•The safety of the PillCam SB capsule has not been established in children below two years of age.
•The safety of the PillCam ESO/PillCam UGI capsule has not been established in patients below
age 18.
•The safety of the PillCam COLON capsule has not been established in patients below age 18.
•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.
•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.
•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
!
Warning
PillCam capsules are MR unsafe.
PillCam Capsule Endoscopy
6 Warnings
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.
•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.
•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.
•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.
•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.
•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.
•If a child has accidentally swallowed any unused or spent PillCam video capsule, seek medical
attention.
•Instruct the patient not to sit on bare metal surfaces, such as chairs with metal seating area, during the
procedure.
•Instruct the patient to contact the physician immediately if, after ingesting any PillCam video capsule,
there is any abdominal pain, nausea, or vomiting.
•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.
•If, contrary to instructions, a patient ingests more than one PillCam video capsule, instruct the patient
to immediately contact the physician.
•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.
•The safety of this device in pregnant women has not been established.
•The safety of this device in patients with significant gastrointestinal diverticular disease is unknown.
•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:
•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.
•Store all PillCam video capsules in a safe place, out of the reach of children and infants.
•Do not use any PillCam video capsule after its expiration date.
•Instruct the patient to avoid biting the PillCam video capsule prior to swallowing.
Indications, Contraindications, Warnings, Cautions
Warnings 7
•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.
•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.
•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.
•PillCam Capsule Endoscopy System and its components need special precautions regarding
Electromagnetic Compatibility (EMC) to avoid loss of image transfer resulting in video gaps.
PillCam Capsule Endoscopy System needs to be installed and put into service according to the
Electromagnetic Compatibility (EMC) information provided in the accompanying documents.
•The 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:
•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.
•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.
•Never connect the PillCam recorder to the sensor array while the PillCam recorder is in its cradle.
•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.
•Portable and mobile RF communications equipment can affect the PillCam video capsule and the
PillCam recorder.
•The PillCam video capsule may be interfered with by other equipment, even if that other
equipment complies with CISPR emission requirements.
•The Lithium-Ion battery pack in the PillCam recorder DR3 incorporates built-in safety devices.
•Do not use the PillCam recorder in a location where static electricity (greater than the
manufacturer’s guarantee) may be present. Otherwise, the safety devices can be damaged, possibly
leading to acid leakage, overheating, smoke emission, bursting and/or ignition.
PillCam Capsule Endoscopy
8 Cautions
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.
•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.
•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.
•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.
•Final diagnosis based on the RAPID video should be made only by physicians who are trained in the
interpretation of capsule endoscopy images.
•The Lithium-Ion battery pack in the PillCam recorder DR3 incorporates built-in safety devices. Do not
use the PillCam recorder in a location where static electricity (greater than the manufacturer’s
guarantee) may be present. Otherwise, the safety devices can be damaged, possibly leading to acid
leakage, overheating, smoke emission, bursting and/or ignition.
Benefits and Risks—PillCam Capsule Endoscopy
Benefits
•PillCam capsule endoscopy is the most widely used patient-friendly tool for visualization of the GI
tract. To date, more than 2,000,000 patients worldwide have benefited from PillCam endoscopy.
•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.
•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.
•The procedure does not require sedation, intubation, bowel insufflation or radiation.
•Patients may continue with their normal daily activity during the procedure.
Indications, Contraindications, Warnings, Cautions
Benefits and Risks—PillCam Capsule Endoscopy 9
•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 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.
•Capsule retention has been reported in less than two percent of all capsule endoscopy and patency
procedures. Capsule retention is defined as having a capsule remain in the digestive tract for more
than two weeks.
•Causes of retention cited in the literature include: NSAID strictures, Crohn's disease, small bowel
tumors, intestinal adhesions, ulcerations, and radiation enteritis. Summaries in published literature
identify the 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.
•There is an extremely rare risk of capsule aspiration while patients are attempting to swallow a
PillCam video capsule or Patency capsule.
•There is also a low risk of skin irritation from the sensor array sleeve adhesive or silicone exposure.
•The PillCam SB video capsule 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.
•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.
•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
PillCam Capsule Endoscopy
10 Essential Performance
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).
Indications, Contraindications, Warnings, Cautions
Accuracy of the Device—SB 11
The localization software was studied in a series of 17 healthy subjects. Multiple fluoroscopic images
(92 sets) were obtained at various times during the PillCam video capsule's passage through the small
bowel. The location was assessed in two dimensions relative to the umbilicus and then compared to the
position obtained from the localization software. When compared to the relative two-dimensional
location determined fluoroscopically, approximately 87% (80/92) of the PillCam video capsule
estimates were within 6cm (a “fist”). The mean error for PillCam video capsule localization was found
to be 3.8 cm. [2]
The Suspected Blood Indicator (SBI) feature is intended to mark frames suspected of containing fresh
blood. The feature may be activated only after labeling the first duodenal image and marks frames
contained only within the small bowel. The SBI feature should not serve as a substitute for a physician's
complete viewing of the video but rather to provide supplemental information afterwards. All events
marked by the SBI feature should be carefully reviewed by a physician. In a review of 27 patients with
at least one red or bleeding lesion found by a physician on capsule endoscopy, the SBI feature correctly
marked 439, or 88%, of the 498 individual lesions. In addition, a total of 561 false positive lesions were
marked by the feature, giving a positive predictive value (PPV) of 44%. [3]
References:
[1] Clinical report presented in K010312
[2] Clinical report presented in K020341
[3] Clinical report presented in K022980
PillCam Capsule Endoscopy
12 Accuracy of the Device—ESO
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.
All patients underwent esophageal capsule endoscopy as well as esophagoscopy, to compare the results of
the esophageal capsule endoscopy with conventional video EGD (imperfect standard) in assessing
endoscopic findings of the esophagus.1
The study was too small to accurately assess the agreement with lesions other than the most common
findings—esophagitis and suspected Barrett’s esophagus. There were several other lesions which were
noted as depicted in the table below.
Rate of
Agreement
(95% CI)
Rate of False
Pos (95% CI)
Rate of False
Neg (95% CI)
Overall
Agreement
(95% CI)
Esophagitis 85%
(69%; 95%)
13%
(4%; 27%)
12%
(3%; 27%)
Suspected BE 81%
(62%; 94%)
15%
(6%; 30%)
15%
(4%; 34%)
Normal 70%
(53%; 83%)
OVERALL 78.3%
(69%; 86%)
1.Clinical report presented in K041149
# Cases Diagnosed
by EGD
# Cases correctly
Diagnosed by CE Agreement
Hiatal Hernia 37 6 16%
Stricture 5 1 20%
Polyps/Nodules 3 0 0%
Varices 1 1 100%
֠
֠֠
֠Note
The PillCam ESO 1 capsule was not able to reliably identify:
• Precise location of lesion(s)
• Length or extent of lesion(s)
• Severity or grade of lesion(s)
Indications, Contraindications, Warnings, Cautions
Accuracy of the Device—UGI 13
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 12
to 24 hours. One patient was unable to swallow the CE capsule. The results from the patients with
completed CE examinations demonstrated the presence of blood in the upper gastrointestinal tract in 15
patients. The results of the EGD examination for the 15 patients with blood in the upper gastrointestinal
tract included 8 (53%) patients with normal or non-clinically significant findings which included:
•Normal: n = 2
•Hiatal hernia: n = 1
•Esophagitis: n = 2
•Gastritis/Duodenitis: n = 3
There were 16 (35%) patients that had no evidence of blood in the upper gastrointestinal tract at the time
of the CE examination, but had clinically significant lesions identified at the time of upper endoscopy
examination which included:
•Mallory-Weiss tear: n = 1
•Esophageal varices: n = 1
•Gastric/Duodenal ulcers: n = 11
•Gastric masses: n = 3
The results are summarized in the below table [1]:
Diagnosis and detection of gross blood by capsule endoscopy compared to EGD
No Patient
Detection of
Gross blood
by Capsule
endoscopy
Detection of
Gross blood
by EGD
Diagnosis Based on CE
Findings
Diagnosis
Based on EGD
Findings
1 001SIT No No Gastric Ulcer in antrum Gastric Ulcer,
Gastritis
2 002GBA No No Duodenitis Duodenal
Ulcer, gastritis
3 003VSA Yes No Normal Normal
4 004KAY Yes Yes Esophageal Varices Esophageal
Varices
5 005ZOV No No Gastric Ulcer Normal
6 006ROY Yes No Coffee grounds Gastritis, duo-
denitis
PillCam Capsule Endoscopy
14 Accuracy of the Device—UGI
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 No Normal Duodenum
Ulcer
16 008NMP Not applicable Yes Patient unable to swallow
capsule
Gastric and
Duodenal
ulcers
17 009CMT No No Duodenal Ulcer Duodenum
Ulcer
18 010PSN No No Normal Esophageal
nodule
19 011YYT Yes No Duodenal Ulcer Duodenal Ulcer
20 012FYL No No Erosive Esophagitis Erosive esoph-
agitis, Gastric
Ulcer, Duode-
nal ulcer
21 013-SH No No Normal Gastritis
22 014MFN Yes No Duodenitis Esophagitis
23 015LKN No No Gastritis Normal
24 016CWK No No Normal Gastritis, Duo-
denitis
25 017SLW No No Normal Gastritis
26 018-HW Yes No Gastric Ulcer Gastric Ulcer
27 019SCN No No Normal Normal
28 020CSC No No Gastric Ulcer Suspected gas-
tric cardia malig
Diagnosis and detection of gross blood by capsule endoscopy compared to EGD
Indications, Contraindications, Warnings, Cautions
Accuracy of the Device—UGI 15
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 applica-
ble
Patient withdrew Patient with-
drew
35 027SML No No Normal Gastric and
Duodenal
ulcers
36 028KHN No No Duodenal Ulcer Gastric Ulcer
37 029CTT No No Gastric Ulcer Gastritis
38 030MLC No No Duodenal Ulcer Gastroduode-
nal ulcer
39 031CKL No No Normal Gastritis,
Esopahgitis
40 032KCL No No Gastric Ulcer with visible
vessel
Duodenal Ulcer
41 033WLC No No Esophagitis, gastritis, duode-
nitis
Esophagitis,
gastritis, duo-
denitis
42 034YCL Not applicable Not applica-
ble
Patient withdrew Patient with-
drew
43 035LNC No No Normal Gastric mass
44 036SKH Yes No Esopahgitis and Duodenal
Ulcer
Esophagitis
45 037CYL No No Erosive esophagitis, gastritis Mallory-Weiss
Tear
46 038WSC No Yes Normal Gastric Ulcer
47 039Y-F No No Esophageal Varices, gastric
and duodenal erosions
Esophageal
Varices
48 040WCL No No Normal Duodenal Ulcer
Diagnosis and detection of gross blood by capsule endoscopy compared to EGD
PillCam Capsule Endoscopy
16 Accuracy of the Device—UGI
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. Endoscopy. 2013;45 (1):12-9.
49 041K-L Yes No Normal Gastritis
Diagnosis and detection of gross blood by capsule endoscopy compared to EGD
Indications, Contraindications, Warnings, Cautions
Accuracy of the Device—COLON 2 17
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. The primary objective of the study was
to compare CCE with optical colonoscopy (OC) for agreement on absence or presence of colon polyps
(≥6 mm or ≥10 mm). There were a total of 17 enrollment sites; 11 were located in the US and 6 were
located in Israel.
Study Design and Accountability
CCE was performed on subjects 6 weeks prior to their OC procedure in order for a central reader to
interpret the CCE results prior to OC. In the initial phase of the study, colonoscopists were blinded to
CCE results when evaluating their OC findings. The data analysis for this phase of the study is reported
here.
A total of 884subjects were enrolled using the following inclusion criteria:
•Subject is between the ages of 50 and 75 years
•Subject is classified as average risk per the American Gastroenterological Association (AGA)
Guidelines on colorectal cancer (CRC) Screening (individuals without a personal or family history
of CRC or adenomas, inflammatory bowel disease, or high-risk genetic syndromes).1
Among the 884 subjects enrolled, 184 subjects were excluded from the effectiveness analysis. A total of
104 subjects (11.8%) were excluded due to issues related to the performance of the CCE including 77
(8.7%) that were excluded on the basis of an inadequate colon preparation prior to CCE or a rapid
transit of the capsule through the colon. A total of 63 subjects withdrew from the study. Two subjects
were excluded because of OC procedure violations. One site was terminated due to major protocol
violations, accounting for 15 excluded subjects. The samples included in the study were average risk
asymptomatic, first time screening patients undergoing colonoscopy. The use of CCE has not been
evaluated in other populations.
A total of 700 subjects successfully completed an investigation with both CCE and OC and were
included in the effectiveness analysis. The data analysis of the effectiveness of CCE was undertaken on
a per subject basis. The comparison of CCE with OC was based on the presence or absence of at least
one finding of a polyp of size in diameter (≥6 mm or ≥10 mm) identified on OC.
PillCam COLON 2 bowel preparation:
PillCam COLON 2 bowel preparation included administration of 4 Senna tablets, a clear liquid diet and
administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution
divided into two doses: the first dose on the evening before the exam (2 liters) and the second dose on
the morning of the exam day (2 liters).
1.AGA Guidelines: Screening and Surveillance for the Early Detection of Colorectal Cancer and Adenomatous Pol-
yps, 2008: A Joint Guideline From the American Cancer Society, the US Multi-Society Task Force on Colorectal
and the American College of Radiology; Gastroenterology 2008;134:1570-1595.
PillCam Capsule Endoscopy
18 Accuracy of the Device—COLON 2
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. Upon SB detection, a first boost of 6 ounces diluted to 16 ounces was administered. Unless
the PillCam capsule was excreted, a second boost of 3 ounces diluted to 8 ounces may have been
administered 3 hours after the first boost. If towards the end of the procedure (2 hours after the second
boost) the capsule was not excreted, the subject was asked to take a 10mg Bisacodyl suppository according
to package insert instructions. Subjects were allowed to eat 2 hours after suppository intake or after capsule
excretion.
Subjects were encouraged to drink clear liquids such as water, isotonic drinks, tea or other pulp-free juices
throughout their preparation and examination.
Descriptive Analysis Sizes of the largest colon polyp identified in a subject by OC and CCE, regardless of
segmental location, were compared (Table 1). In particular, on OC 219 subjects were identified as having a
colon polyp that measured 5 mm or less in diameter, 115 subjects were identified as having a colon polyp
equal to or greater than 6 mm in diameter, but less than 10 mm in diameter, and 77 subjects were identified
as having a colon polyp measuring at least 10 mm in diameter. The overall prevalence of subjects with any
polyp found on OC was 58.7% (411/700). The prevalence of subjects found to have at least one polyp at
least 6 mm in diameter was 27.4% (192/700), and the prevalence of subjects found to have at least one
polyp at least 10 mm in size was 11.0% (77/700).
Among 115 subjects with a polyp identified on OC that was greater than 6 mm but less than 10 mm in
diameter, CCE also identified 55 (47.8%) subjects with a polyp greater than 6 mm but less than 10 mm in
diameter anywhere in the colon, and 19 (16.5%) subjects with a 10 mm in diameter sized polyp, for a total
of 74 subjects (64.3%) with a CCE detected polyp of 6 mm or greater.
Among 77 subjects with a polyp identified on OC that was greater than 10 mm in diameter, CCE identified
a polyp anywhere in the colon less than 6 mm in diameter in 12 (15.6%) subjects, a polyp greater than 6 mm
but less than 10 mm in diameter in 18 (23.4%) subjects, and a polyp measuring at least 10 mm in diameter
in 37 (48.1%) subjects. Thus, CCE identified a total of 55 subjects (71.4%) with a polyp of 6 mm or greater.
CCE failed to identify any polyp of 6 mm or greater in 22 (28.6%) subjects and any polyp of 10 mm or
greater in 40 (51.9%) subjects.
Table 1: Comparison of the polyp with the largest diameter (mm) identified by OC and CCE in a subject,
regardless of segmental location
Max CCE
(mm)
Max OC (mm)
0 0<OC<6 6≤OC<10 10≤OC Total
0 168 84 20 10 282
0<CCE<6 90 71 21 12 194
6≤CCE<10 18 52 55 18 143
10≤CCE 13 12 19 37 81
Total 289 219 115 77 700
Indications, Contraindications, Warnings, Cautions
Accuracy of the Device—COLON 2 19
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. The colon segment location of the
reference OC polyp was determined and recorded as the cecum, ascending colon, transverse colon,
descending-sigmoid colon or rectum. The largest polyp identified on CCE within the same or an
adjacent segment location of the “reference OC” polyp was used to determine agreement with OC based
on a size-matching algorithm. If there were two polyps of equal size that were “the largest” and located
in different segments of the colon, the location and size-matching algorithm was repeated on each of
these reference OC polyps to determine agreement of CCE with OC. In such instances, the reference
OC polyp chosen for the final determination was the one that was in favor of the device. A full
description of the location and size-matching algorithm is given in the Appendix.
For each subject, the CCE evaluation was classified into one of four categories of agreement with OC:
true positive (TP) agreement, false negative (FN) disagreement, false positive (FP) disagreement, or
true negative (TN) agreement. Letting TP, FN, FP, and TN denote the number of subjects that fall into
these categories (Table 2), the estimates of positive percent agreement (PPA) and negative percent
agreement (NPA) of CCE with OC are defined as follows:
PPA = 100 × TP / (TP+FN)
NPA = 100 × TN / (FP+TN)
Tables 3 and 4 display the observed 2 by 2 categorical data when, respectively, 6 mm and 10 mm are
used as the size thresholds for defining a subject as positive for a polyp. From these data tables, PPA and
NPA are estimated along with their 95% confidence intervals (Table 5).
Table 2: Format for reporting agreement results in a 2 x 2 categorical table
CCE
OC
negative positive
negative TN FN
positive FP TP
Table 3: Observed Categorical Data, 6 mm Threshold
CCE
OC
negative positive Total
negative 413 60 473
Positive 95 132 227
508 192 700
PillCam Capsule Endoscopy
20 Accuracy of the Device—COLON 2
Using the 6 mm or greater sized polyp threshold, the positive and negative percent agreements of CCE with
OC were, respectively, 68.8% (132/192, 95% CI 61.7-75.2%) and 81.3% (413/508, 95% CI 77.6-84.6%).
Using the 10 mm or greater sized polyp threshold, the positive and negative percent agreements were
64.9% (50/77, 95% CI 53.2-75.5%) and 92.9% (579/623, 95% CI 90.6-94.8%).
Following the completion of a colonoscopy when the polyp detected on CCE was not identified, the results
of the CCE evaluation were unblinded and the colonoscopy was repeated in a second attempt to identify the
polyp identified on CCE. The unblinded colonoscopy results for the >=6 mm threshold showed a 1% and
3% increase in the positive and negative percent agreement values, respectively. The unblinded
colonoscopy results for the >=10 mm threshold showed a 1% increase in the positive and negative percent
agreements.i ii
Notes:
i. Five of ninety-five patients who per protocol should have undergone a second OC procedure were determined not to require it by
the physician.
ii. The reported positive and negative percent agreement of the unblinded analysis are potentially biased because OC was repeated
only on those patients with an initial CCE false positive finding and not also on those patients with an initial CCE true negative
finding based on the blinded OC evaluation.
Table 4: Observed Categorical Data, 10 mm Threshold
CCE
OC
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. 95% CI based on Clopper Pearson
Indications, Contraindications, Warnings, Cautions
Accuracy of the Device—COLON 2 21
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., severe gagging reflex and mild vomiting and abdominal cramping).
•Eleven adverse events were reported as related to the colonoscopy procedure as follows:
• 6 moderate adverse events, out of which 5 occurred in the same subject and resolved within the
same day (i.e., fever, headache, abdominal pain, bloating and nausea); a second subject suffered
from moderate abdominal pain that resolved within 3 days.
• 5 mild adverse events resolved within 8 days (i.e., abdominal pain / cramping (3 cases), fever
and bleeding-old blood).
The remaining 128 adverse events were reported as related to the colon preparation (prior to CE and
optical colonoscopy procedures).
Appendix
Definitions of categories of subject level agreement of CCE with OC used in location- and size-
based agreement analysis
Agreement Analysis, polyp size threshold 6 mm
When no OC polyp ≥ 6 mm was detected, a CCE finding of no polyp ≥ 6 mm would be a True Negative
finding. A CCE finding of a polyp ≥ 6 mm anywhere in the colon would be a False Positive finding.
When an OC polyp ≥ 6 mm was detected, a CCE polyp that was within the range of 50% smaller
diameter or any size larger in diameter, and located in the same or an adjacent colon segment would be
a True Positive finding. When an OC polyp ≥ 6 mm was detected, a CCE polyp that was below the 50%
smaller diameter in the same or an adjacent colon segment would be a False Negative finding. An
exception was made in the situation where an OC polyp ≥ 20 mm and a CCE polyp ≥ 10 mm were
identified in the same or an adjacent colon segment. This was also considered a True Positive finding.
Agreement Analysis, polyp size threshold 10 mm
The same algorithm would apply for an OC polyp ≥ 10 mm in terms of determining True Positive,
True Negative, False Positive and False Negative findings.
The use of the 50% margin of error rule for the comparison of the diameter of colon polyps as estimated
by both OC and CCE was incorporated into this study analysis in order to be consistent with the two
other published clinical trials comparing the PillCam COLON 2 device and optical colonoscopy.1 2
1.Eliakim R, Yassin K, Niv Y, et al. Prospective multicenter performance evaluation of the second- generation colon
capsule compared with colonoscopy. Endoscopy 2009 Dec;41(12):1026-1031.
2.Spada C, Hassan C, Munoz-Navas M, et al. Second-generation colon capsule endoscopy com-pared with colonos-
copy. Gastrointest Endosc 2011 Sep;74(3):581-589.
PillCam Capsule Endoscopy
22 Accuracy of the Device—COLON 2
Table 6: Examples of Subject Level Classificationsa
Subject Segment OC max
Polyp Size
CCE max
Polyp Size
CCE
Classification
for 6 mm
threshold
CCE
Classification
for 10 mm
threshold
1 cecum - -
1 ascending - -
1 transverse 5 -
1 desc-sigmoid - 6
1 rectum 20 -
Subject Level classification FN FN
2 cecum - -
2 ascending - -
2 transverse 5 -
2 desc-sigmoid - 5
2 rectum 8-
Subject Level classification TP TN
3 cecum - 4
3 ascending 9 -
3 transverse - -
3 desc-sigmoid - -
3 rectum 11 5
Subject Level classification FN FN
4 cecum - 6
4 ascending 9-
4 transverse - -
4 desc-sigmoid - -
4 rectum 954
Subject Level classification TP TN
Indications, Contraindications, Warnings, Cautions
Accuracy of the Device—COLON 2 23
5 cecum - 7
5 ascending - -
5 transverse - -
5 desc-sigmoid - -
5 rectum 5-
Subject Level classification FP TN
6 Cecum - 5
6 Ascending - 5
6 Transverse - 5
6 desc-sigmoid - 5
6 rectum 5-
Subject Level classification TN TN
7 cecum - -
7 ascending - -
7 transverse - -
7 desc-sigmoid - -
7 rectum - -
Subject Level classification TN TN
7 cecum - -
7 ascending 30 -
7 transverse - 11
7 desc-sigmoid 9 -
7 rectum - -
Subject Level classification TP TP
7 cecum 25 -
Table 6: Examples of Subject Level Classificationsa
Subject Segment OC max
Polyp Size
CCE max
Polyp Size
CCE
Classification
for 6 mm
threshold
CCE
Classification
for 10 mm
threshold
PillCam Capsule Endoscopy
24 Accuracy of the Device—COLON 2
7 ascending - 60
7 transverse - -
7 desc-sigmoid - 6
7 rectum - -
Subject Level classification TP TP
7 cecum - -
7 ascending 811
7 transverse - -
7 desc-sigmoid - -
7 rectum - -
Subject Level classification TP FP
7 cecum - -
7 ascending - 6
7 transverse 18 -
7 desc-sigmoid - -
7 rectum - -
Subject Level classification FN FN
a. OC index polyps appear in bold face
Table 6: Examples of Subject Level Classificationsa
Subject Segment OC max
Polyp Size
CCE max
Polyp Size
CCE
Classification
for 6 mm
threshold
CCE
Classification
for 10 mm
threshold
Indications, Contraindications, Warnings, Cautions
Accuracy of the Device—COLON 2 25
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)).
Prospective multicenter performance evaluation of the second-generation colon capsule
compared with colonoscopy1
This trial was conducted in Israel by Eliakim et al to evaluate the ability of the PillCam COLON 2
capsule endoscopy system to detect polyps and other pathologies in the colon. A total of 104 patients
were enrolled using the following inclusion criteria:
1. Subject is between the ages of 18 and 57 years
2. Subject is able and agrees to sign the Informed Consent Form
• Subject was referred to colonoscopy for at least one of the following reasons:
• Colorectal cancer screening
• Clinical symptoms such as: rectal bleeding, hematochezia, melena, positive fecal occult blood
test (FOBT), recent change of bowel habits, or diarrhea/constipation of recent onset
• Positive findings in the colon on a GI radiographic study
• Personal history of colorectal cancer (CRC) or adenomatous polyps and at least 5 years since
last conventional colonoscopy
Patients were excluded from the study for the standard contraindications for small bowel capsule
endoscopy such as:
1. Dysphagia,
2. Life threatening conditions,
3. Use of a pacemaker,
4. Current pregnancy,
5. Use of nonsteroidal anti-inflammatory drugs (NSAIDs), or
6. Contraindications to bowel preparation and prokinetic agents used in the study.
98 patients were included in the accuracy analysis with 66% males and 34% females at an average age
of 49.8 years (18-57). For the detection of patients with polyps ≥6 mm, a true positive result was
considered when at least one polyp equal to or larger than 4 mm was identified by PillCam COLON 2
and at least one polyp equal to or larger than 6 mm was identified by colonoscopy. For the detection of
patients with polyps ≥ 10 mm, a true positive result was considered when at least one polyp equal to or
larger than 7 mm was identified by PillCam COLON 2 and at least one polyp equal to or larger than
10 mm was identified by colonoscopy.
1.Eliakim R, Yassin K, Niv Y, et al. Prospective multicenter performance evaluation of the second- generation colon
capsule compared with colonoscopy. Endoscopy 2009 Dec;41(12):1026-1031.
PillCam Capsule Endoscopy
26 Accuracy of the Device—COLON 2
The accuracy of the PillCam COLON 2 capsule endoscopy system for patients with polyps is listed in the
table below:
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 pathologies in the colon. A total of 117
patients were enrolled using the following inclusion criteria:
1. Subject is between the ages of 18 and 80 years
2. Subject is referred to colonoscopy for at least one of the following reasons:
• Colorectal cancer screening,
• Clinical symptoms such as: rectal bleeding, hematochezia, melena, positive FOBT, recent change
of bowel habits for age ≤50,
• Positive findings in the colon (e.g. Polyp ≥ 10mm), or
• Personal history of significant polyps (≥ 6 mm) that were removed 3 or more years previously.
Patients were excluded from the study for the following reasons:
1. Dysphagia or any swallowing disorder,
2. Congestive heart failure,
3. Allergy or other known contraindication to the medications used in the study,
4. An increased risk for capsule retention (i.e. Crohn’s disease, previous abdominal surgeries, ongoing
nonsteroidal anti-inflammatory drug use), or
5. Cardiac pacemaker or other implanted electromedical device.
109 patients were included in the accuracy analysis with 59% males and 41% females at an average age of
58.0 years (26-79). For a given polyp to be considered a match between PillCam COLON 2 and
colonoscopy, it had to be assessed within 50% of the size of the largest estimate of the two studies and as
appearing within the same colon segment or in adjacent segments. Following the polyp-match algorithm,
for a patient to be considered to be a true-positive at least one polyp in a given size category (i.e., equal to or
larger than 6 mm or equal to or larger than 10 mm), had to be present in PillCam COLON 2 and
colonoscopy reports.
Accuracy ≥ 6 mm ≥ 10 mm
Sensitivity %
(95% CI)
89%
(70%–97%)
88%
(56%–98%)
Specificity %
(95% CI)
76%
(72%–78%)
89%
(86%–90%)
1.Spada C, Hassan C, Munoz-Navas M, et al. Second-generation colon capsule endoscopy compared with colonoscopy.
Gastrointest Endosc 2011 Sep;74(3):581-589.
Indications, Contraindications, Warnings, Cautions
Accuracy of the Device—COLON 2 27
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%)
PillCam Capsule Endoscopy
28 Accuracy of the Device—COLON 2
What is PillCam Capsule Endoscopy? 29
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.
The PillCam Capsule Endoscopy Process
The PillCam capsule endoscopy (CE) process consists of the following steps:
•Preparing the patient and the system for the ingestion of the capsule
•Performing the capsule endoscopy procedure
•Video creation
•Video review and interpretation
PillCam Capsule Endoscopy System Components
The PillCam capsule endoscopy (CE) system components that support the PillCam capsule endoscopy
process consist of the following:
•PillCam capsules, which acquire pictures of the gastrointestinal tract and transmit them to the
PillCam recorder.
•PillCam recorders with PillCam sensors, which receive and store the images collected during the
procedure for subsequent video creation with the RAPID software.
•RAPID software, which processes and transforms the raw image data stored in the recorder into a
conveniently viewable RAPID video and allows review of the RAPID video.
PillCam Capsules
PillCam capsules are video cameras designed specifically for imaging the intestinal tract. Each capsule
is equipped with a tiny battery, a transmitter with antenna, and LEDs (light-emitting diodes) for each
video camera head. These components are enclosed in a biocompatible plastic casing. A capsule is
about the size of a large vitamin pill.
PillCam Capsule Endoscopy
30 PillCam Capsule Endoscopy System Components
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 contain one video camera. PillCam SB 1 is a fixed frame rate first generation capsule,
PillCam SB 2 is a fixed frame rate second generation capsule, while PillCam SB 3 is a third generation
capsule with enhanced imaging capabilities with adaptive frame rate (AFR).
PillCam ESO/UGI capsules contain two video cameras (one at each end) with prolonged operation time and
adaptive frame rate.
PillCam COLON capsules contain two video cameras (one at each end). The PillCam COLON 2 capsule
has enhanced imaging capabilities with adaptive frame rate (AFR).
After activation and ingestion, the capsule is propelled by peristalsis through the gastrointestinal tract.
During this process, the video cameras acquire images and the transmitter sends them, via the sensors, to
the PillCam recorder for storage.
For full technical specifications of PillCam capsules, see System Specifications on page 217. For
indications and contraindications, see Indications, Contraindications, Warnings, Cautions on page 3.
!
Caution
The PillCam capsule transmits at a specific frequency of 434.1MHz in a
bandwidth of ± 10MHz. Occasionally, interference from external devices
transmitting in the same bandwidth may occur that may interrupt or limit the
effective performance of the capsule transmission.
The following possible cases could occur:
• Car or house alarm: These operate with momentary transmissions.
Depending on the proximity of the car or house alarm transmitter to the
ingested capsule, there could be a momentary interference that should not
damage the capsule video.
• Police/Fire stations radio equipment: These may operate with more
extended transmission durations. Depending on the proximity of the car or
house alarm transmitter to the ingested capsule, this could cause longer
duration interference, possibly causing gaps in the capsule video.
PillCam SB capsules:
small bowel
PillCam COLON capsule:
colon
PillCam ESO/UGI capsules:
esophagus and upper GI
Welcome to PillCam Capsule Endoscopy
PillCam Capsule Endoscopy System Components 31
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:
PillCam Recorders
The PillCam recorder is a compact battery-operated unit worn by the patient during the procedure.
It receives and stores the image data transmitted by the PillCam capsule. There are two models currently
available: PillCam recorder DR3 and PillCam recorder DR2.
The PillCam recorder is supplied with a pouch to wear over the shoulder and with an adjustable strap to
secure to the waist.
!
Caution
• Keep the PillCam capsules in their box until use.
• Store the PillCam capsules only in the packaging supplied with the product.
• Do not use a PillCam capsule if the packaging is damaged.
• Keep the capsule package away from strong magnetic fields (such as MRI
devices).
• Stack PillCam capsule boxes with the clear lid facing up only; never stack
capsule boxes lid to lid.
• Keep metal objects away from the lid of the capsule box.
•For procedures involving the visualization of the colon: After ingesting
the PillCam COLON capsule, instruct the patient not to sit on bare metal
surfaces, such as chairs with a metal sitting area, during the procedure.
DR2 DR3
PillCam Capsule Endoscopy
32 PillCam Capsule Endoscopy System Components
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. Each sensor consists of a flexible printed circuit board (PCB)
and is attached with a disposable, medical adhesive sleeve.
The PillCam sensor array and belt are connected to the PillCam recorder by a flexible cable.
RAPID for PillCam Software
The RAPID for PillCam software (RAPID v8.3) supports the PillCam capsule endoscopy procedure by
providing access to the different steps in the PillCam capsule endoscopy procedure via the Home screen.
Home Screen
After starting the RAPID v8.3 software, the Home screen appears. The Home screen is the main screen
that provides access to all phases of the PillCam capsule endoscopy procedure.
The Home screen enables the following functions:
•Patient Check-in: Admitting the patient and initializing PillCam recorder.
•Recorder Download: Creating the RAPID video.
•View Study: Viewing videos and allowing interpretation as well as generating capsule endoscopy
report (see Reviewing and Interpreting RAPID Videos on page 97).
֠
֠֠
֠Note
The PillCam Capsule Endoscopy System does not contain any natural
rubber latex components.
Welcome to PillCam Capsule Endoscopy
PillCam Capsule Endoscopy System Components 33
֠
֠֠
֠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.
1
11
1Patient Check-in: Opens the patient check-in wizard to enter information about the
patient and the procedure and to initialize the PillCam recorder with this data. There are a
series of screens that walk you through the check-in process (see Performing Patient
Check-in on page 43).
2
22
2Recorder Download: Opens a screen to download data from a PillCam recorder (see
PillCam Recorder Download on page 89) and to create a RAPID video from the data.
3
33
3View Study: Clicking this button opens a menu that provides access to:
•Study Manager: Allows easy access to all studies. The Study Manager allows you to
open, search, sort, delete, and export studies (see Using the Study Manager on
page 107).
•Open Video: Open a saved RAPID video and findings, if available, by opening a
windows screen that enables you to locate the RAPID video.
•Recent Videos: Displays recently viewed RAPID videos that can be selected and
opened.
2
22
2
3
33
3
4
44
4
1
11
1
5
55
5 6
66
6
PillCam Capsule Endoscopy
34 PillCam Capsule Endoscopy System Components
RAPID software is supplied as:
•Software only: Installs on your PC.
•RAPID workstation: Dedicated PC with RAPID pre-installed.
4
44
4Tools: 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).
•Atlas: Opens an atlas of typical disease images searchable by key descriptors and
used as a viewing aid for comparing study images with reference images (see RAPID
Atlas on page 153).
•Delete Videos: Delete a RAPID video folder and its contents (see Freeing Space on
Your Computer on page 195).
•User Dictionary: Import or export term dictionary used in writing comments and study
summary.
5
55
5Help: Clicking this button opens a menu that provides access to:
Help: Selecting Online Help in the submenu opens a searchable PDF version of this
user manual. Selecting Help Center will direct you to the RAPID Help Center. The Help
Center provides quick references for How to questions and additional tools including
video clips and step-by-step demonstrations to facilitate learning of Capsule Endoscopy
procedures and the RAPID software.
Customer Support: The menu provides a link to Given Imaging contact information for
customer support (see Customer Support Section on page 182), an option to collect
analysis files and to show the RAPID log.
6
66
6Exit: Closes the RAPID software.
Welcome to PillCam Capsule Endoscopy
PillCam Capsule Endoscopy System Components 35
•RAPID Reader: A limited version of the software; all RAPID features are available except for
creating videos.
Before using the RAPID software, you must configure and personalize it. Refer to Configuring RAPID
Software on page 169 for more details.
֠
֠֠
֠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.
Throughout this manual, RAPID implies any version unless specifically
noted.
֠
֠֠
֠Note
Videos created using capsule procedures prior to PillCam SB 2 can be
viewed in RAPID v8.3.
RAPID v8.3 does not support patient check-in for these earlier capsule
types.
PillCam Capsule Endoscopy
36 PillCam Capsule Endoscopy System Components
Preparing the Patient 37
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 Equipment on patient (see Fitting Equipment on the Patient on page 51)
Preparing the Patient
Once it is decided that the patient should undergo capsule endoscopy:
1. Verify that no contraindications apply to the patient (see Indications, Contraindications, Warnings,
Cautions on page 3).
2. Inform the patient:
a. Inform the patient of the small possibility of bowel obstruction.
b. Inform the patient of the importance of a clean bowel for the success of his or her PillCam
examination.
c. Instruct the patient what to expect before, during, and after the procedure.
d. Instruct the patient on the proper use of the PillCam recorder:
• The patient must treat the PillCam recorder with care. Avoid any sudden movements. Avoid
bumping it.
• The patient should not remove or disconnect the PillCam recorder at any time during the
procedure.
• The patient should contact the medical staff if the PillCam recorder is blinking red or white.
• The patient must follow the dietary instructions from the medical staff or when alerted by the
PillCam recorder.
e. If the patient experiences any abdominal pain, nausea, or vomiting after ingesting the PillCam
capsule, the patient should immediately inform the medical staff.
f. After ingesting the PillCam capsule and until it is excreted, the patient should not go near any
source of a powerful electromagnetic field, such as one created near an MRI device and
should avoid direct exposure to bright sunlight.
g. If the patient experiences any post-procedure abdominal pain, vomiting, or other unexplained
symptoms and PillCam capsule excretion cannot be verified, the patient should contact the
physician for evaluation and possible abdominal X-ray procedure.
PillCam Capsule Endoscopy
38 Preparing the Required Equipment
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. Remind them about
appropriate clothing:
• If using the sensor belt, upper garment of thin, natural fiber cloth that is long enough to reach at
least to hip level and will not ride up above the belt.
• If using the sensor array, loose-fitting, two-piece opaque clothing.
Preparing the Required Equipment
Before the patient arrives for the procedure, verify that the following equipment and accessories are
available:
•RAPID (installed, configured, and open after accepting the license agreement)
•PillCam capsule (ESO/UGI, SB, COLON)
•PillCam recorder
•PillCam recorder pouch with shoulder strap
•Printed instructions for the patient
•Prepared PillCam sensor belt or PillCam sensor array with sensors already inserted in sleeves
•Sensor Location Guide (ESO/UGI, SB, SB Pediatric, or COLON) if you are using a sensor array
•Water and drinking cup
•Any medication prescribed for the patient during the procedure
Connecting the PillCam Recorder to RAPID for Check-in
The PillCam recorder must be connected to RAPID during patient check-in. The check-in process allows
entering patient and procedure data for the procedure and saves the correct patient and procedure
information to the PillCam recorder. The process is explained in detail in this section.
The PillCam recorder connects to the RAPID workstation or Personal Computer (PC) via the cradle.
1. Make sure RAPID is On.
2. Make sure the PillCam recorder is firmly inserted into the cradle.
!
Caution
Connection of the PillCam recorder to the RAPID software for patient check-
in, video download, and recorder upgrade must be done using the cradle.
Preparing for PillCam Capsule Endoscopy
Preparing the Required Equipment 39
3. Click Patient Check-in on the RAPID Home screen.
4. In the Procedures screen, select the Recorders tab.
5. Click the Recorder bar to connect the function buttons to the PillCam recorder:
֠
֠֠
֠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.
Button Action
Identifies the PillCam recorder for the selected recorder bar.
When you click this button, all the LEDs on the associated
PillCam recorder and cradle blink.
Prepares the PillCam recorder for the capsule endoscopy
procedure by entering patient data.
PillCam Capsule Endoscopy
40 Creating Patient Instructions for the Procedure
Creating Patient Instructions for the Procedure
Patient Instructions are handouts used to guide the patient in preparing for the PillCam capsule endoscopy
procedure.
Pre-ingestion Instruction Handouts
PillCam SB procedure goes with predefined pre-ingestion instruction text.
PillCam ESO/UGI procedure also goes with predefined pre-ingestion instruction text.
PillCam COLON procedures go with customizable pre-ingestion instructions that can be created by the
physician using the Regimen Manager tool. In general, pre-ingestion bowel preparation for PillCam capsule
endoscopy of the colon includes cessation of iron supplement intake several days before capsule ingestion,
then adherence to a Clear Liquid Diet starting from at least a full day before capsule ingestion, to be
followed by customizable laxative intake with water at least the evening before ingestion as well as the
morning of ingestion. All these instructions including the customized laxatives are embedded in the pre-
ingestion regimen instructions.
Pre-ingestion instructions for the respective PillCam procedures are printed and given to the patient before
the day of the procedure.
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.
֠
֠֠
֠Note
When performing check-in with RAPID v8.3, video download must be done
using RAPID v8.3.
Button Action
Preparing for PillCam Capsule Endoscopy
Creating Patient Instructions for the Procedure 41
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. This is achieved by
instructing the patient in real-time during the procedure to conditionally follow a set of instructions
involving timely ingestion of prokinetics and laxatives. The post ingestion instructions are grouped in
a regimen that is selected by the physician from a library of possible regimens and are loaded into the
PillCam recorder DR3 during patient check-in (see Performing Patient Check-in on page 43) and they
are also printed out in a handout to the patient. During the PillCam COLON procedure, the PillCam
recorder DR3 alerts the user to perform the instructions detailed in the corresponding post-ingestion
instructions handout.
The post-ingestion instructions, i.e. a regimen, consists in general of the following conditional
instructions:
•Continue fasting until capsule leaves the stomach.
•If capsule is delayed in stomach, ingest a customized prokinetic agent.
•Intake the first boost laxative dose (and water when necessary) directly after capsule leaves the
stomach.
•Intake the second boost laxative dose (and water when necessary) 2 - 4 hours after the capsule
leaves the stomach.
•Eat a light meal (depending on capsule progress) 1 - 3 hours after second laxative.
•Take a suppository 1 - 2 hours after the meal (if required).
The execution of these instructions in a regimen is triggered by appropriate alerts from the PillCam
recorder which senses the fulfillment of the conditions for the respective instructions and cues the
patient during the procedure to refer to the associated instruction and execute it.
The difference between the regimens is in the use of specific laxative and prokinetic materials as well as
some timing differences associated with these different materials.
It may happen that the execution of the instructions, some of which drive the capsule through the
gastrointestinal tract, needs to be delayed until the patient reaches suitable environment for the intake of
the associated laxatives. Such a case is when the ingestion is at the physician's office but the rest of the
procedure may take place at the patient's home. Under such circumstances, it is desirable to delay the
capsule-driving instructions until the patient reaches home. The setting for delay of prompting by alerts
may be achieved by appropriate programming of the PillCam recorder DR3, either through check-in
(see Performing Patient Check-in on page 43) or through direct programming before capsule pairing
(see Setting Delay First Instruction in PillCam Recorder on page 79).
The Regimen Manager tool enables the creation and editing of post-ingestion patient instructions for
colon procedures.
Refer to the Regimen Manager section (Regimen Manager on page 183) to familiarize yourself with
this tool.
For pre-capsule ingestion regimen refer to Pre-ingestion Instruction Handouts on page 40, and for post-
capsule ingestion regimen, refer to Post-ingestion Instructions for Procedures Involving Colon
Visualization on page 41.
PillCam Capsule Endoscopy
42 General Patient Guidelines During the Procedure
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 of the instruction to be performed at the
alert time. When the PillCam recorder beeps and vibrates he or she should do the following:
a. Check the instruction number on the PillCam recorder LCD screen.
b. Press the Acknowledge button on the upper right corner of the PillCam recorder for at least 3
seconds.
c. Follow the corresponding post-capsule ingestion instruction on the supplied printed out.
d. Follow instructions only when prompted by the PillCam recorder and only the instruction that
matches the displayed number, even if the PillCam recorder skips a number.
e. The PillCam recorder DR3 displays the End of Procedure screen , beeps and vibrates
when the procedure is over and shuts down automatically after five minutes.
•Avoid any physical activity that involves sweating, bending, or stooping.
•Remain active. Do not sleep.
•Use the bathroom as often as needed (do not suppress the urge). The use of wet wipes and cream to
protect the skin is recommended.
•Avoid any source of powerful electromagnetic field (such as an MRI device).
•DR3 only: Do not remove the PillCam recorder until the capsule is excreted or the End of Procedure
instruction appears on the PillCam recorder.
•DR3 only: If the capsule LED at the top of the recorder is blinking red, move to a different location
until the capsule LED on the top of the PillCam recorder has resumed blinking blue.
•DR2 only: If the LED of the top of the PillCam recorder stops blinking blue before the timeouts
specified in the next section for the different capsules, contact the medical staff.
•DR3 only: The end of the procedure for a PillCam recorder DR3 is when the End Of Procedure
instruction is alerted and displayed on the recorder screen.
The end of a procedure may also be declared by the medical staff after proper consultation if the
blinking stopped before the above specified times.
•DR2 only: In the event that no transmissions are received from the capsule (the PillCam recorder stops
blinking blue) for more than 60 minutes, the PillCam recorder will shut down.
•At the end of the procedure, remove the PillCam recorder and sensors. If you need assistance, or were
instructed to do so, return to the clinic to have this done.
•Contact the medical staff in case of any unexpected event or doubt.
Preparing for PillCam Capsule Endoscopy
Performing Patient Check-in 43
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.
For colon visualization procedures: patient check-in also programs the PillCam recorder to provide
post-ingestion patient alerts. It also allows you to print out the selected post-ingestion instructions for
the patient. Make sure that the RAPID workstation or PC is connected to a printer (for printing the post-
ingestion patient instructions).
1. Make sure the PillCam recorder is fully charged and connected to RAPID.
2. From the Home screen, click Patient Check-in.
3. In the Procedures screen, click the Recorder bar.
4. Click Check-in Patient.
֠
֠֠
֠Note
Make sure that an approved post-ingestion regimen is available in the
Regimen Manager before performing patient check-in (see Post-Ingestion
Patient Instructions on page 187).
Recorder bar
PillCam Capsule Endoscopy
44 Performing Patient Check-in
!
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.
• For the PillCam recorder DR2, follow the instructions detailed in the Note
below.
֠
֠֠
֠Note
PillCam recorder DR2 only: If the PillCam recorder needs a software
update, this message appears: This recorder requires a software update.
Do you want to update the recorder software version?
We highly recommend you perform this upgrade unless you are an ESO 2
user. Upgrading the DR2 to SB 3 support will deactivate ESO 2 support. If you
are working with several recorders, designate which will support ESO 2
procedures and which will support SB 3 procedures.
• Click Yes and follow the instructions on the screen. When the update is
done, remove the PillCam recorder from its cradle and reinsert it.
• To ignore the update, click No. You may continue the check-in and perform
the update later.
• Selecting the Don’t show this message again checkbox will disable
further updates to this specific recorder. This option is available only if you
are logged in as the administrator.
Preparing for PillCam Capsule Endoscopy
Performing Patient Check-in 45
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
46 Performing Patient Check-in
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. In the list next to Display at the top of the screen, you can select which
patient list you wish to see: Available for Check-in or Already imported.
To delete a patient from the Already imported list, select the relevant line and click Delete.
Once you click OK, the first check-in screen appears again, with all available information already
entered. You may need to complete additional mandatory or optional procedure information (such
as capsule ID) not auto-populated from the HIS (see the RAPID v8.3 IT Guide). When all necessary
data entry is completed, you may proceed to the Procedure info confirmation screen by clicking
the Next or Finish buttons or by changing any of the information fields.
Manual Data Entry: You can enter patient information manually.
a. Enter the patient’s Last, First, and Middle names into the appropriate fields. Use alphanumeric,
underscore, hyphen, and space characters. Use the TAB key to move to the next field.
b. Enter the patient ID number in ID.
c. Select the Gender.
d. In Birth Date, set the patient’s date of birth.
e. In Procedure Date, enter the date on which the procedure is to be performed. By default, it is set
for current date.
f. In Capsule ID, if filling this field during check-in, enter the capsule ID code that is printed on
the bottom of the capsule box (by typing it in or by using a barcode). The capsule type field is
automatically populated according to the capsule type encoded in the capsule ID entered.
Capsule ID
Preparing for PillCam Capsule Endoscopy
Performing Patient Check-in 47
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. To ensure accurate localization information use only the sensor type that you defined
in the check-in process.
7. Click Next to continue.
8. For PillCam COLON 2 procedures only: Select a regimen and print it out to hand it out to the
patient before capsule ingestion. Use the Delay first instruction? checkbox (ON by default) to
determine if a predefined minimum 90 minute free-of-instructions period will or will not be forced
between the time of ingestion and the first instruction to the patient. If the delay first instruction is
set, the first instruction to the patient will be either alert 0 (if still relevant) or alert 1:
•Alert 0: An instruction #0 (based on time passed from capsule ingestion) to take prokinetics to
facilitate passage of the PillCam COLON 2 capsule to the small bowel. Threshold of time
passed from capsule ingestion for alert 0 can be modified in the regimen manager for a specific
regimen.
•Alert 1: An instruction #1 for taking laxative after detection by the PillCam recorder of PillCam
COLON 2 passage into the small bowel. It coincides with the activation of the AFR mode in the
PillCam COLON 2 capsule and the appearance of the AFR status icon in the right corner of the
status line at the top of the PillCam recorder DR3 display. The appearance of alert 1 can be
designated to appear either an additional 0 minutes or 15 minutes after original tentative alert 1
timing. Alert 0 will not occur if alert 1 was raised before it.
If you do not change this parameter during check-in, it remains in its default state (ON for “Delay
first instruction”, i.e. delayed) but you may set it also through the PillCam recorder DR3 before
pairing the PillCam COLON 2 capsule to the PillCam recorder DR3.
9. Click Next to continue.
PillCam Capsule Endoscopy
48 Performing Patient Check-in
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
Performing Patient Check-in 49
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. For Recorder serial number, enter the PillCam recorder serial number.
f. Click Next to continue.
PillCam Capsule Endoscopy
50 Performing Patient Check-in
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.
Updating Patient Details
Patient details are collected during the Patient Check-in process. However, RAPID allows you to change
or update all the patient information after a video creation.
To update patient details:
1. Find the study in the Study Manager.
2. Right-click the study and select Update Patient Details.
The following screen appears. Make the desired changes and click Next until you have completed your
update.
֠
֠֠
֠Note
When the patient check-in is complete, the capsule LED on the PillCam
recorder lights up in orange.
After patient check-in, keep the PillCam recorder in its cradle until the
capsule ingestion procedure begins.
Preparing for PillCam Capsule Endoscopy
Fitting Equipment on the Patient 51
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.
Depending on the sensor belt, for sanitary purposes some models may require the fitting of a single use
disposable protective sleeve while other models feature a reusable washable external fabric sleeve.
The image above of the PillCam sensor belt is for reference only. Sensor belt models may differ from
image.
֠
֠֠
֠Note
Refer to the product insert supplied with your sensor belt for full instructions
on fitting, usage, cleaning, and technical description.
PillCam Capsule Endoscopy
52 Fitting Equipment on the Patient
Applying the PillCam Sensor Array
The sensor array allows the PillCam recorder to collect localization data during a procedure. The
prescribing physician may request this. To prepare the sensor array:
1. Insert each sensor into an adhesive sleeve. The sensor markings (dots or this side up) should face
away from the adhesive side of the sleeve.
2. To secure the sensor in the sleeve, remove the liner from the topside of the lower lip at the opening of
the adhesive sleeve and press both lips together.
3. Place the sensors on the patient according to the appropriate placement guides (see ESO/UGI Sensor
Locations on page 54, SB Sensor Locations on page 55, or COLON 2 Sensor Locations on page 56).
Necessary Equipment and Accessories
To attach the sensor array to the patient, you need the following equipment:
•Sensor array
•Sensor Location Guide (ESO/UGI, SB, COLON)
•Adhesive sleeves, to hold each one of the sensors securely in place
•Razor and disinfectant (not supplied), to shave the area of the sensors on the abdomen
To attach the sensor array:
1. DR3 only: With the patient standing and exposing the thorax and abdominal area, place the sensor
array loop on the left shoulder. If the loop is too long, gather and fasten the surplus in the fastener.
2. Ask the patient to lie down.
3. Use the appropriate Sensor Location Guide to identify the location of each sensor on the patient's body
and mark it with a dot.
4. The sensor array sleeves should be applied to hairless skin. If needed, wipe the patient's skin with
disinfectant and shave the areas where sensors are to be applied.
֠
֠֠
֠Note
Sensor arrays must be applied directly to smooth skin. Anything that comes
between the patient's skin and the sensors, including hair or air, and any
changes in the sensors' arrangement, may interfere with the quality of the
data.
!
Warning
Do not use the sensor array if it is torn or damaged.
Sensor inside adhesive
sleeve between two layers
Lower lip with liner on
the top side
Preparing for PillCam Capsule Endoscopy
Fitting Equipment on the Patient 53
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.
If you are using a sensor array with a downlink loop, adjust the downlink loop to remove excess
cable so that it fits closely to the patient's body. To prevent damage to the wires do not forcibly
bend the downlink loop in any way.
7. When the patient gets dressed, make sure that the sensor array connector remains outside of the
patient's clothing and make sure that the patient is not uncomfortable with the equipment.
֠
֠֠
֠Note
Since the sensors are placed on the body according to anatomical reference
points, the distances between sensors may vary from patient to patient.
X√
√√
√
PillCam Capsule Endoscopy
54 Fitting Equipment on the Patient
ESO/UGI Sensor Locations
Sensor Label Sensor Color Sensor Location
A Black Upper Sternum (on the bone)
B Yellow Xiphoid process
C Brown Intersection of left 7th intercostal space
and left mid-clavicular line
PillCam recorder DR3 PillCam recorder DR2
Preparing for PillCam Capsule Endoscopy
Fitting Equipment on the Patient 55
SB Sensor Locations
For DR3:
For DR2:
Standard Sensor Location Guide Pediatric Sensor Location Guide
PillCam Capsule Endoscopy
56 Fitting Equipment on the Patient
COLON 2 Sensor Locations
Sensor Label Sensor Color Sensor Location
A Black Intersection of right 7th intercostal space and
right mid-clavicular line
B Yellow Xiphoid process
C Brown Intersection of left 7th intercostal space and left
mid-clavicular line
D Blue Right lumbar region at umbilical level
E Purple Above umbilicus (navel)
F White Left lumbar region at umbilical level
G Green Right mid-inguinal region
H Red Left mid-inguinal region
Sensor Label Sensor Color Sensor Location
A Black Intersection of right 7th intercostal space and
right mid-clavicular line
B Yellow Mid upper region of right gluteus
C Brown Intersection of left 7th intercostal space and left
mid-clavicular line
D Blue Right lumbar region at umbilical level
E Purple Suprapubic region
F White Left lumbar region at umbilical level
G Green Right mid-inguinal region
H Red Left mid-inguinal region
Preparing for PillCam Capsule Endoscopy
Fitting Equipment on the Patient 57
Before dispensing the PillCam capsule, the equipment must be prepared.
Attaching the Sensors to the PillCam Recorder
The PillCam recorder is worn by patients during the procedure in the recorder pouch with shoulder
strap or in the recorder belt with suspenders. Make sure that these accessories fit the patient
comfortably.
Recorder Pouch
To fit the recorder pouch:
1. With the patient standing, hang the recorder pouch from the patient’s shoulder as displayed in the
illustration.
2. Adjust the shoulder strap so that the recorder hangs at the patient's side at waist level with the
supplied strap securing the recorder to the waist.
֠
֠֠
֠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.
!
Caution
• Make sure that there is no other PillCam capsule or other diagnostic
capsule in the patient’s gastrointestinal tract.
• Verify that the capsule expiration date has not passed (see the date next
to the icon on the packaging).
• If you are performing the procedure for the first time, read the capsule
package insert.
PillCam Capsule Endoscopy
58 Fitting Equipment on the Patient
PillCam Recorder Belt
To fit the recorder belt:
1. With the patient standing, place the belt around the patient’s waist.
2. Adjust the belt to fit the patient. Add the belt extension if needed.
3. Make sure that the PillCam recorder DR2 pouch is at the patient’s hip as shown here. The belt has a
Velcro strap for attaching the pouch, allowing the patient to adjust the pouch as needed.
4. Adjust suspender length and location to fit the patient.
PillCam Recorder DR2 and DR3
To assemble PillCam recorder accessories:
1. Remove the PillCam recorder from the cradle. If the PillCam recorder is properly initialized and ready
for the procedure, the capsule LED is constantly on in orange.
2. Verify that the battery is fully charged:
• For PillCam recorder DR2, all battery LEDs should light up.
• For PillCam recorder DR3, the battery icon on the screen should be .
֠
֠֠
֠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.
PillCam recorder DR2
in pouch on the left
Suspenders
Preparing for PillCam Capsule Endoscopy
Fitting Equipment on the Patient 59
3. Insert the PillCam recorder into its pouch. Instruct the patient to keep wearing the PillCam recorder
during the examination.
The pouch or belt is ready and the patient can wear it.
Positioning PillCam Recorder DR3
1. Make sure the PillCam recorder is on (navigation button LEDs blink once every 5 seconds).
2. With the patient standing, hang the pouch from the patient’s left shoulder to the right hip.
3. Insert the sensor connector into the PillCam recorder’s slot until you feel and hear a click.
If the sensor is not properly connected to the recorder, appears on the PillCam recorder
screen (see PillCam Recorder DR3 on page 209 for troubleshooting details).
4. If using a PillCam sensor array, tuck the vibrating connector component between the recorder
pouch and the patient's abdomen. This will ensure that the tactile vibrating alerts will be felt by the
patient.
!
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.
• Attach the sensor connector to the PillCam recorder immediately prior to
capsule ingestion.
•PillCam recorder DR3 only: make sure that the connector component is
placed between the patient’s body and the PillCam recorder DR3 waist strap.
•PillCam recorder DR2 only: if the blue LED is blinking before you open the
PillCam capsule box, reinitialize the PillCam recorder.
DR2 DR3
A
B
PillCam Capsule Endoscopy
60 Fitting Equipment on the Patient
Positioning PillCam Recorder DR2
1. If you are using the recorder pouch, hang it from the patient’s shoulder while the patient is standing.
If you are using the recorder belt, secure it around the patient’s waist, while the patient is standing.
2. Make sure the locking handle at the back of the PillCam recorder is open.
3. Slide the two protrusions on the connector into the matching grooves in the PillCam recorder.
4. Verify that the connector is inserted completely, and then lock it by closing the handle on the PillCam
recorder.
5. Make sure that the PillCam recorder is on (the battery LEDs light up once every 5 seconds).
֠
֠֠
֠Note
The sensor array connector and wire should hang over the top of the
recorder belt.
Locking handle
is open before
connecting
sensor array
Protrusions on
connector
Grooves in
PillCam
recorder
Closed handle
Preparing for PillCam Capsule Endoscopy
Fitting Equipment on the Patient 61
֠
֠֠
֠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.
• Make sure nothing other than a single, thin layer of fabric is allowed to
come between the sensor belt and the abdomen.
• In order to avoid pulling the sensor belt out of position, do not attach or
anchor anything to the sensor belt.
• Be sure that the PillCam recorder is worn over the sensor belt and that
the PillCam recorder pouch is not attached to the PillCam sensor belt.
• Another layer of clothing may be worn over the sensor belt as long as
the sensor belt connecting wire can be attached to the PillCam recorder.
PillCam Capsule Endoscopy
62 Fitting Equipment on the Patient
Preparing the PillCam Recorder 63
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. The DR3 model is the newest model and works
with all types of PillCam capsules and provides advanced functions of real-time viewing during the
procedure. The DR2 model is the previous model and it works with all types of PillCam capsules in a
fixed frame rate mode.
Both recorder models are provided with a cradle (for charging and connecting to a PC) and a pouch (to
allow the patient to wear the PillCam recorder during the procedure).
Functions
Initialization
Initialization is a mandatory operation before the procedure. With the PillCam recorder connected to
RAPID, the patient and procedure data are uploaded to the PillCam recorder so that the ensuing study
and procedure data are personalized. The initialization of the PillCam recorder is performed through the
RAPID check-in process (see Performing Patient Check-in on page 43), while the PillCam recorder is
connected to RAPID through its cradle. The PillCam recorder is a passive element in this process and
no control or operation on it is required.
Pairing for DR3
Pairing is performed before PillCam capsule ingestion, the capsule and PillCam recorder are made to
connect so the PillCam recorder is tuned to the transmissions only from the paired capsule.
Pairing for PillCam recorder DR3 may be performed either through the check-in process in RAPID by
entering the capsule ID during check-in, or directly using the recorder control buttons before ingestion
(see PillCam Recorder—Capsule Pairing (DR3 only) on page 80). Pairing is mandatory when working
with a PillCam recorder DR3 in order to enable recording.
Real-Time Viewing
Real-time viewing is an optional function whereby the images captured by the capsule and received by
the PillCam recorder are displayed to the user in real-time for review by the physician. The PillCam
recorder DR2 provides this functionality only in conjunction with a dedicated tablet PC connected to it
during the procedure. The PillCam recorder DR3 provides this functionality both through a dedicated
֠
֠֠
֠Note
For full technical specifications about the PillCam recorders and their
cradles, see System Specifications on page 217.
PillCam Capsule Endoscopy
64 PillCam Recorder DR3
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.
Download
Download is the transfer of the stored raw procedure data from the PillCam recorder to RAPID and the
creation of a RAPID video for subsequent review.
Before you perform your first PillCam procedure, make sure that you are familiar with the controls and
functions of the PillCam recorder.
PillCam Recorder DR3
General
The PillCam recorder DR3 battery is limited to 400 recharge cycles. RAPID will display a notification at
approximately 385 cycles prompting you to replace the battery. Contact customer service for a replacement
battery when the battery notification appears, or when the battery reaches 3 years of service; whichever
occurs first.
RAPID will alert the user when the number of recorder uses is close to the allowed limit.
֠
֠֠
֠Note
SD Card: The SD card in the PillCam recorder DR3 may not be used
externally to perform a patient check-in.
Use of SD cards not supplied by Given Imaging in the PillCam recorder DR3
may cause the device to malfunction or lead to data corruption or loss.
!
Caution
The SD card should never be removed or reinserted when the PillCam
recorder DR3 is ON.
Know Your PillCam Recorder
PillCam Recorder DR3 65
Turning On and Off
The illustration below shows the PillCam recorder DR3 sitting in the 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.
The On/Off button is on the left side of the PillCam recorder DR3:
•To turn on, press and hold the On/Off button for 5 seconds until you see the startup screen. All
LEDs start to flash. (The full start-up sequence takes about one minute.)
•To turn off, press and hold the On/Off button for 5 seconds until the PillCam recorder DR3 beeps
and the screen turns off and the button LEDs turn black.
֠
֠֠
֠Note
Automatic Shutdown:
• After the PillCam recorder DR3 has been checked in, it goes into standby
mode ready to receive capsule signals when removed from its cradle. If
after 90 minutes no capsule pairing is performed, the PillCam recorder
DR3 automatically shuts down.
• After starting to receive signals from a paired capsule, if there is a gap of
30 minutes with no signal reception from the paired capsule, the PillCam
recorder DR3 will shut down.
֠
֠֠
֠Note
When the PillCam recorder DR3 is on, its screen backlight goes into an off
mode if the screen or recorder controls are idle for more than 3 minutes. If
the PillCam recorder DR3 is on, but the screen is off, press any key to turn
the screen on. Once the PillCam recorder DR3 screen is activated, proceed
with pressing the desired function button.
ON/OFF
button
Acknowledge button
Capsule and message LEDs
Line for
status icons
Message area
Navigation
buttons
Cradle
PillCam Capsule Endoscopy
66 PillCam Recorder DR3
Regimen Reminder
Regimen Reminder is a reminder function, whereby the PillCam recorder alerts the patient to perform
dietary instructions during a PillCam COLON 2 procedure. The alerts are timely instruction numbers that
appear on the recorder screen together with some audio and tactile alerts to draw the patient's attention to
the alerted instruction number. The patient is required to acknowledge the alert by pressing an
acknowledge button on the recorder and execute the associated instruction detailed on a patient instruction
sheet. The PillCam recorder DR3 is programmed during the initialization to remind the user according to
an uploaded regimen instruction set which is also printed out and handed to the patient. The timing of the
regimen instructions is synchronized to the moment of PillCam recorder DR3 pairing with the PillCam
capsule.
The last instruction alerted is displayed on the screen of the PillCam recorder DR3.
Charging
Charge the PillCam recorder DR3 by placing it in the cradle. The cradle charges the PillCam recorder DR3
and also connects it to the PC for performing patient check-in and creating videos. There are two LEDs at
the base of the cradle.
•The top LED is orange when the PillCam recorder DR3 is in the cradle.
•The bottom LED is orange while charging and green when the PillCam recorder is fully charged.
There is a power connector on the back panel of the cradle:
power connector
Know Your PillCam Recorder
PillCam Recorder DR3 67
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.
Controls
Main Display
The main display of the PillCam recorder DR3 displays the relevant information during the different
phases of the capsule endoscopy procedure.
After Initialization (after check-in) and before pairing with the capsule, the recorder display shows the
relevant procedure information data, as follows:
After pairing with the capsule, the display shows the relevant procedure information data, as follows:
!
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.
Battery charge level Capsule signal level
Status line
Patient name
Patient ID
Capsule type
Last Regimen instruction
Audio alert control Icon to toggle delay
first instruction
Recorder status: unpaired
Battery charge level Capsule signal level
Status line
Patient name
Patient ID
Capsule type
Last Regimen instruction
Audio alert control
Recorder status: paired
Real-Time viewing
PillCam Capsule Endoscopy
68 PillCam Recorder DR3
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. The graphic indication in the top right corner of the
displayed alert indicates that an acknowledge response is required by pressing the acknowledge button.
Error messages appear similarly over the main screen (see Error Messages on page 73).
LED Display
The top of the PillCam recorder has a small screen on which the capsule and message LEDs are displayed.
These LEDs indicate the status of the PillCam recorder and the capsule endoscopy procedure. For
example, when the capsule LED on the PillCam recorder blinks in blue, this means that PillCam recorder
is receiving data from a capsule.
For a complete list of all capsule and message LEDs, see PillCam Recorder DR3 LEDs on page 70.
Acknowledge (ACK) Button, Designated for Patient Use
During a capsule endoscopy procedure, patients press the Acknowledge button in response to PillCam
recorder message alerts that appear on the recorder display. This ensures that the patient acknowledges the
instruction message. This can include regimen instruction messages during post-ingestion regimen (see
Post-Ingestion Patient Instructions on page 187).
•The acknowledge button will simultaneously blink with the display of any regimen reminder popup in
PillCam recorder DR3 LCD display and it will keep blinking until patient pressed the acknowledge
button for 3 sec or the popup display has reached its time out duration.
•At the end of 3 sec continuous pressing on the acknowledge button the blinking will go off.
Regimen reminder alert
Message LEDCapsule LED
Know Your PillCam Recorder
PillCam Recorder DR3 69
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.
Button Pressing Indication
The following audio (beep) and visual feedbacks alert the user when pressing buttons on the PillCam
recorder DR3:
•If the backlight is off: Pressing any button for the first time or turning on the PillCam
recorder DR3 turns the backlight on. This action is not accompanied by audio feedback.
•If the backlight is on:
• Momentarily pressing a button that affects a function, such as volume control, Real-Time
viewing combination, scrolling up/down or left/right, and selecting buttons, results in audio
(beep) feedback.
• Continuously pressing a button (i.e. press the Acknowledge button for 3 seconds), results in
audio (beep) feedback at the end of the required duration (i.e. at the end of 3 seconds).
• Momentarily pressing a button that is designed to activate a function after continued pressing
(i.e. Acknowledge), is not accompanied by audio or visual feedback.
•If the volumes is set to “off”, no audio indications should play.
Icon Action when pressed Icon Action when pressed
Confirm/select Manually activate AFR mode in PillCam
COLON 2 capsule and activate instruction #1
if gastric passage of the capsule is detected
and the AFR mode was not entered
automatically
Scroll up the cursor Activate Real-Time viewing (followed by
pressing the left then right buttons within 6
seconds)
Scroll down the cursor Mark displayed frame
Exit Real-Time viewing Switch video head (in Real-Time viewing
mode)
PillCam Capsule Endoscopy
70 PillCam Recorder DR3
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.
PillCam Recorder DR3 LEDs
The status indications of the LED indicators on the top of the PillCam recorder DR3 for the most common
PillCam recorder events are as follows:
Icon Battery Status Icon Capsule Reception Status
Battery fully charged Signal weak, recording with
noise
Battery charge level at 10%
intervals
Signal strong, recording with
noise
Battery empty, PillCam
recorder shuts down
Signal weak, but recording OK
Battery charging Signal strong, and recording
OK
LEDs PillCam Recorder DR3 Status
CHECK-IN
Blinking in white
PillCam recorder DR3 is being checked in.
Blinking rate = very fast.
Constant on in white
PillCam recorder DR3 is checked in and ready to receive
capsule signals.
Blinking in white
PillCam recorder DR3 is checked in and receiving signals
from an unpaired capsule.
Blinking rate = capsule frame rate.
RECORD
Blinking in blue at capsule
frame rate
PillCam recorder DR3 is receiving paired capsule signals and
recording.
Blinking rate = capsule frame rate.
LEDs off Recording done and raw data is available for downloading.
DOWNLOAD
Blinking in green
PillCam recorder DR3 has started downloading.
Constant on in green
PillCam recorder DR3 has completed downloading.
Know Your PillCam Recorder
PillCam Recorder DR3 71
Navigation Buttons Legend
Screen Icons
These icons appear as recorder status on the rightmost icon of the top status line of the PillCam
recorder DR3 screen:
General Indications
Blinks in yellow/orange every
5 seconds
PillCam recorder DR3 has stopped receiving capsule signals
for more than 5 seconds.
Constant on in white with error
message
PillCam recorder DR3 has stopped recording because the
memory card is full.
Blinking in green
There is an instruction on the PillCam recorder DR3 screen.
Constant on in red
PillCam recorder DR3 is malfunctioning.
Blinking in red
PillCam recorder DR3 detects capsule signal, but is not
recording it. This is a malfunction. Check the sensor
connection or have patient move to a different location.
Blinking in blue
The navigation buttons blink in blue every 5 seconds when
the PillCam recorder DR3 is on, either in or out of the cradle,
and the LCD screen is off. To turn the LCD screen back on,
press any button on the PillCam recorder DR3.
Icon Action when pressed Icon Action when pressed
Mark displayed frame. Activate Real-Time viewing
(followed by pressing the left
then right buttons within 6
seconds).
Switch video head (in Real-
Time viewing mode).
Icon Explanation Icon Explanation
No capsule is paired. No sensor is connected.
Pairing succeeded. PillCam recorder DR3 is
checked in.
LEDs PillCam Recorder DR3 Status
PillCam Capsule Endoscopy
72 PillCam Recorder DR3
Check-in Screen Icons
After performing patient check-in, these icons appear on the PillCam recorder screen data area:
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.
End of procedure icon
appears on the main screen
and indicates that the
procedure has ended and
equipment may be removed. It
occurs when a predefined
reception gap from the paired
capsule is encountered.
Regimen reminder numbers
appear on the main screen to
alert the user to perform
dietary instructions.
In Real-Time Viewing mode,
the Regimen Reminder
number appears on the top
right corner of the screen.
Icon Explanation Icon Explanation
Patient name Procedure type and
capsule ID
Patient ID
On Off
Regimen Delay first
instruction status
indicator and navigation
button designator
Icon Explanation Icon Explanation
Know Your PillCam Recorder
PillCam Recorder DR3 73
Error Messages
During operation, the following messages may appear in the PillCam recorder main screen.
Popup 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 write-
protected.
Sensor hardware failure.
Consult a technician.
Memory card error.
Remove and reinsert card.
Wrong sensor type.
Insufficient memory on card. Fatal error.
Consult a technician.
PillCam Capsule Endoscopy
74 PillCam Recorder DR2
PillCam Recorder DR2
General
The PillCam recorder DR2 battery is limited to 350 use cycles. Contact customer service for a
replacement battery when necessary.
Turning On and Off
This illustration shows the front and back view of the PillCam recorder DR2:
The On/Off button is on the top left side on the back of the PillCam recorder DR2:
•To turn on, press and hold the on/off button until you hear a long beep followed by a short one and the
LEDs start flashing.
•To turn off, press and hold the On/Off button until you hear a beep and the LEDs turn off.
֠
֠֠
֠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.
֠
֠֠
֠Note
Automatic shutdown: After the PillCam recorder DR2 has been checked
in, it goes into standby mode ready to receive capsule signals when
removed from its cradle and starts recording as soon as a signal is received
from a transmitting capsule. If after removal from the cradle no signal is
received for 90 minutes, the PillCam recorder DR2 automatically shuts
down.
After starting to receive signals from a capsule, if there is a gap of 60
minutes of no signal reception, the recorder shuts down.
Locking
handle in
open position
PillCam
recorder DR2
LED Capsule LED ON/OFF button
Battery
LEDs
Know Your PillCam Recorder
PillCam Recorder DR2 75
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. Push it all the way down into the cradle and make sure you hear a series of beeps, indicating that
connection is complete.
.
There are four connections on the back panel of the cradle. Only two of them are used with standard
operation of the cradle: the power connector and the USB cable connection.
The cradle also connects the PillCam recorder to the Personal Computer (PC).
•The green LED on the cradle indicates that the PillCam recorder DR2 is fully charged and ready
for use.
•The red LED, when lit continuously, indicates a defective battery.
•The red LED, when blinking, indicates that there is a problem with the cradle.
PillCam Recorder DR2 LEDs
When the PillCam recorder DR2 is on, it starts recording as soon as it receives a signal from a PillCam
capsule. When the capsule LED blinks, the PillCam recorder DR2 is receiving data. When the signal
from the PillCam capsule is too weak, the LED does not blink.
!
Warning
Do not connect the PillCam recorder DR2 to the
sensor array while the PillCam recorder DR2 is in
its cradle.
Capsule LED
Recorder LED
PillCam Capsule Endoscopy
76 PillCam Recorder DR2
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.
PillCam recorder shuts down if no capsule signals are received for more than
30, 60, or 90 minutes, depending on the PillCam recorder software version.
PillCam recorder is exchanging status or data with RAPID or RAPID RT.
LED blinking rate varies according to the communication flow.
PillCam recorder is capturing capsule signals.
Blinking rate = capsule frame rate.
PillCam recorder has stopped capturing capsule signals for more than 5
seconds.
PillCam recorder is detecting a capsule in sleep mode.
Blinking rate = every five seconds (in any color).
PillCam recorder is malfunctioning.
<20 seconds
PillCam recorder is synchronizing with a capsule. This is normal functioning.
>20 seconds
PillCam recorder detects capsule signal, but is not recording it. This is a
malfunction.
Check the sensor array connection or have patient move to a different location.
maximum Battery charge level:
When charging, the battery LEDs do not blink.
When PillCam recorder is out of the cradle, the battery
LEDS blink once every 5 seconds.
25%
below 10%
Know Your PillCam Recorder
Connecting a PillCam Recorder to a Personal Computer (PC) 77
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.
•Connect for charging: For charging the PillCam recorder after the procedure: to prepare the
recorder for the next procedure.
•Connect for upgrading: When the software version of the PillCam recorder is lower than the latest
one internally specified in RAPID, the user is prompted to allow a recorder upgrade the first time
the recorder is connected to RAPID for check-in. It is highly recommended to allow the upgrade.
The latest software versions for both PillCam recorder DR2 and PillCam recorder DR3 are stored
in RAPID and when prompted and allowed, the appropriate upgrade will be performed.
The PillCam recorder is connected to the PC only through its cradle, each model through its cradle.
The PillCam recorder is passive during these cases and no controls need be operated on it.
Connecting a PillCam Recorder to the External
Real-Time Viewer
The PillCam recorder may be connected to an external real-time viewer, which is a dedicated tablet PC
with real-time viewing software and special setup, for viewing in real-time the images captured and
stored in the recorder. This functionality exists for both recorder types, PillCam recorder DR2 and
PillCam recorder DR3 (the latter has also the built-in capability to perform real-time viewing through
the recorder's display).
For a real-time viewing session, both recorder types connect to the external real-time viewer (tablet PC)
through a USB cable, while the tablet PC or anything connected to it must not be connected, directly or
indirectly to any wall outlet. The real-time viewing software in the tablet PC controls the session and the
PillCam recorder is passive in this configuration. There is no need to use any control button of the
recorders.
֠
֠֠
֠Note
It is recommended to use an external hub when connecting multiple PillCam
recorders.
PillCam Capsule Endoscopy
78 Connecting a PillCam Recorder to the External Real-Time Viewer
Setting Delay First Instruction in PillCam Recorder 79
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. If this flag has not been set properly during check-
in, it needs to be set before ingestion directly on the PillCam recorder prior to pairing with the PillCam
COLON 2 capsule by using the right navigation button with the icon above it to toggle the flag.
The default setting for a PillCam recorder DR3 checked-in with RAPID v8.3, without changing the
Delay first instruction field during check-in, is ON—first instruction delayed. Repetitive use of the
right button will toggle the status of the PillCam recorder DR3 and its status will show in the fourth
icon (from above) in the left most side of the fourth procedure data line.
The fourth line status icon and the button designation icon in the lower right corner of the screen above
the right navigation button will always be opposite. After pairing, the Delay first instruction icon will
disappear and the status will not be changeable any more.
Delay first instruction—Off
Delay first instruction—On
PillCam Capsule Endoscopy
80 PillCam Recorder—Capsule Pairing (DR3 only)
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.
Designation of the capsule to be used in the procedure may be performed during patient check-in or
immediately before capsule ingestion. The following section describes these two scenarios.
Capsule Designation During Patient Check-in
While entering the patient and procedure data during check-in, type the capsule ID in the Capsule ID field
or use a barcode scanner. The capsule ID is displayed on the capsule package.
During recorder initiation, the unique capsule ID will be transferred into the PillCam recorder together with
the rest of the initiation data. It will appear on the PillCam recorder LCD together with the rest of the
patient data.
As long as no transmission from the checked in capsule is received, pairing is not done. The Ready for
pairing icon remains in the top right corner of the screen.
If there are PillCam capsule transmissions received by the PillCam recorder, which are not from the
designated capsule, the capsule IDs of these other capsules (only of the checked-in capsule type) are
temporarily displayed on the PillCam recorder screen. Ready for pairing icon remains in the top right
corner of the screen.
When you open the designated capsule box, just before ingestion, the capsule starts blinking and
transmitting, each capsule type in its unique way. The PillCam recorder will automatically pair to the
designated capsule and start recording when it receives transmissions from it.
The Pairing success icon will appear in the top right corner of the screen.
!
Warning
The PillCam recorder starts recording only after it is paired with the
capsule. If pairing is not complete, no video can be produced. Make sure
you see the Pairing Success icon on the screen and the capsule LED
on top of the recorder blinking in BLUE before capsule ingestion.
Capsule ID
Performing PillCam Capsule Endoscopy
PillCam Recorder—Capsule Pairing (DR3 only) 81
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.
As long as there are PillCam capsule transmissions received by the PillCam recorder but are not from a
designated capsule, the capsule IDs of these other capsules (only of the checked-in capsule type) are
temporarily displayed on the PillCam recorder screen. The Ready for pairing icon remains in the
top right corner of the screen.
To designate and pair a capsule to be used in the procedure before capsule ingestion:
1. Open the capsule box lid—the capsule starts blinking, each capsule in its unique blinking pattern
(see System Specifications on page 217). Right after opening the lid, the blinking rate for
PillCam SB 3 and PillCam COLON 2 capsules should still be 2 fps per head, the same as for
PillCam SB 2. For PillCam SB 2 (fixed 4 fps variant) the blinking rate should be 4 fps. For PillCam
UGI, the blinking rate is 35 fps per head. Hold the capsule close to the sensors worn by the patient
during this pairing process.
2. When the Ready for pairing icon is displayed in the top right corner of the screen and when
the PillCam recorder detects your PillCam capsule, its ID code is displayed on the screen (alone or
in addition to IDs from other capsules).
3. If only one capsule ID appears on the PillCam recorder screen, check the capsule ID shown in the
PillCam recorder screen against the capsule ID displayed on the PillCam capsule package. If the
codes match, press the middle navigation button, above which appears on the screen.
4. If more than one capsule ID appears on the PillCam recorder screen, use the navigation buttons
(located below or icons on the screen) to scroll to your capsule ID and press the middle
navigation button (located below icon on the screen) to designate and initiate pairing of your
capsule with the PillCam recorder.
֠
֠֠
֠Note
Capsule designation during patient check-in is the recommended method for
designating a capsule to be used in the procedure.
This mark indicates that this capsule ID will be
selected when pressing the middle navigation button.
PillCam Capsule Endoscopy
82 Capsule Ingestion
The Pairing success icon will appear in the top right corner of the screen.
Capsule Ingestion
Capsule ingestion is the process of having the patient swallow the PillCam capsule.
֠
֠֠
֠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.
• If, at any time before ingestion, the capsule does not blink for at least 20
seconds, do not use this capsule. Instead, use a different capsule and
repeat the pairing procedure.
֠
֠֠
֠Note
If after designating the capsule:
• the patient does not ingest it within ten minutes, or
• you suspect that the capsule is defective.
Return the capsule into its box. When you close the lid, if the capsule stops
blinking, it is deactivated.
If the capsule continues blinking, rotate it around its axis, without removing it
from its place holder in the box until it stops blinking when you close the lid.
To use this capsule later (if it is not defective), you must repeat the pairing
process.
!
Multiple Procedures
When performing more than one PillCam capsule endoscopy procedure in
the same vicinity, follow these guidelines to prevent signal interference with
other procedures:
• After patient check-in, keep the PillCam recorder in the cradle without
sensors attached until capsule ingestion procedure begins. Return it to
the cradle when the procedure is complete.
•DR2 only: If the blue PillCam recorder LED is blinking before you open
the box of the capsule you intend to use, repeat check-in with the PillCam
recorder (see Performing Patient Check-in on page 43).
• Perform only one capsule ingestion at a time with no other active PillCam
recorder or capsules present in the room.
• Attach sensors to the PillCam recorder immediately prior to the ingestion
after sensors are properly positioned on the patient.
• Do not permit patients wearing PillCam recorders to stay directly next to
other patients with ingested capsules.
• To minimize the potential for radio frequency interference from the
capsule after it is removed from the box, verify that the capsule LEDs are
blinking and have the patient ingest it immediately.
• Once the RAPID video is created, check to be sure the video is complete.
Performing PillCam Capsule Endoscopy
Capsule Ingestion 83
PillCam Recorder DR3
1. Make sure that the capsule and the capsule LED on the PillCam recorder are blinking in time
with each other.
2. Check the color of the capsule LED on the PillCam recorder:
• 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 .
3. Have the patient swallow the capsule with a sip of water. The ingestion procedure may take several
minutes.
PillCam Recorder DR2
1. Make sure that the capsule and the capsule LED on the PillCam recorder are blinking in time with
each other.
2. Position the patient on the bed, with a pillow (6 cm or 2.5 inch high) under the head to facilitate
drinking and ingestion.
3. Instruct the patient not to talk during the procedure.
4. To verify that the system is operating properly, hold the capsule in front of the patient's abdomen
very close to the sensors (practically touching through the clothes one of the sensors). Hold it for at
least 15 seconds and check that the capsule LED on the PillCam recorder blinks at the same rate as
the capsule.
5. Have the patient swallow the capsule with a sip of water.
֠
֠֠
֠Note
During capsule endoscopy, the capsule LED blinks blue at the recording
rate.
If the capsule LED blinks orange once every 5 seconds, the PillCam
recorder is not receiving capsule signals (see PillCam Recorder DR3 on
page 209 for troubleshooting details).
PillCam Capsule Endoscopy
84 After Capsule Ingestion
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. In ESO/UGI capsule procedures,
the End of Procedure icon appears when 10 minutes have passed without paired capsule reception in the
PillCam recorder DR3.
At the end of the procedure, remove the PillCam recorder and sensors from the patient. The patient may
then be released and can return to a normal daily routine.
PillCam SB
Once the patient has ingested a PillCam SB capsule, the patient may leave the clinic. Make sure that the
patient knows which activities to avoid during the procedure and how to return the PillCam recorder and
sensors.
PillCam Recorder DR3
The procedure ends when the End of Procedure screen appears on the PillCam recorder. The PillCam
recorder also beeps and vibrates when the End of Procedure alert appears.
In SB capsule procedures, the End of Procedure icon appears when 25 minutes have passed without paired
capsule reception in the PillCam recorder DR3.
At the end of the procedure, remove the PillCam recorder and sensors from the patient. The patient may
then be released and can return to a normal daily routine.
PillCam Recorder DR2
The procedure lasts as long as the blue PillCam recorder LED is blinking, or until the capsule is excreted.
The PillCam recorder DR2 LED should blink for at least six hours, unless the PillCam SB capsule was
excreted.
At the end of the procedure, remove the PillCam recorder and sensors from the patient. The patient may
then be released and can return to a normal daily routine.
PillCam COLON (DR3 only)
After ingestion, explain the Patient Guidelines (see General Patient Guidelines During the Procedure on
page 42) to the patient.
Explain to the patient what to do when the PillCam recorder beeps or vibrates (see Post-Ingestion Patient
Instructions on page 187).
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.
֠
֠֠
֠Note
When the capsule LED on the PillCam recorder blinks orange, this indicates
that the PillCam recorder is no longer receiving capsule signals.
Performing PillCam Capsule Endoscopy
Real-Time Viewing with PillCam Recorder DR3 Only—Internal Mode 85
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.
•After 10 hours into the procedure, 10 minutes of no paired capsule reception.
At the end of the procedure, the PillCam recorder and sensors may be removed from the patient. The
patient may then return to a normal daily routine.
Real-Time Viewing with PillCam Recorder DR3 Only—
Internal Mode
To activate real-time viewing with PillCam recorder DR3, press the middle navigation button below the
Real-Time icon , then immediately press the left then right buttons one after the other.
The following screen appears on the PillCam recorder.
֠
֠֠
֠Note
Using Real-time Viewing on the PillCam recorder with an external real-time
viewer (laptop) is not supported.
1 32
PillCam Capsule Endoscopy
86 Real-Time Viewing with PillCam Recorder DR3 Only—Internal Mode
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 . The icon displayed above the right navigation button is the mark icon that
allows the marking of the displayed image for automatic creation of a thumbnail and to facilitate further
scrutiny of the image off-line in the created video.
In procedures with non-AFR capsules (PillCam SB 2 and PillCam ESO/UGI) the icon that appears above
the right navigation button in real-time viewing is the mark icon .
For colon visualization procedures: instruction #1 on the PillCam recorder screen appears after the capsule
enters the small bowel, usually within two hours of ingestion. The AFR icon simultaneously appears in
the status line at the top of the PillCam recorder screen, designating the fact that the PillCam COLON 2
capsule passed into the AFR mode operation.
If the system does not show instruction #1 or the AFR icon two hours after ingestion, you can monitor the
capsule location in the GI tract using the real-time viewing. The system will activate by default the AFR
mode and instruction #1 at 4 hours post-ingestion at the latest.
If you need to verify (after instruction #1 on the PillCam recorder screen) that the capsule has left the
stomach, use the real-time viewer:
•If capsule is still in the stomach, repeat real-time viewing to check capsule location every 30 minutes
until you can confirm that it has left the stomach.
•If you visually confirm that the capsule has left the stomach while the AFR indication in the top right
corner of the status line still hasn't changed to , press the right navigation button under the AFR
icon at the right bottom of the screen for 5 seconds. This triggers instruction #1 and activates
recording mode AFR frame rate. The AFR icon appears at the top right corner in the status line of
the screen. The video created from this procedure will start at this point. The mark icon will
appear above the right navigation button instead of the icon.
•Once instruction #1 occurs, the PillCam recorder automatically continues to provide instructions
according to the post-ingestion regimen selected during check-in.
֠
֠֠
֠Note
For colon visualization procedures:
• If the PillCam recorder does not detect that the capsule has entered the small
bowel (either automatically or by the manual procedure described in step 2,
above), the following message appears when opening the video: Gastric-to-SB
passage not detected. In this case, the video is very short (the first 3 minutes
only).
• Some patients may require close supervision to ensure they comply with post-
ingestion instructions. Other patients may be able to function independently as
long as they have access to all needed doses of laxatives and/or prokinetics and
are capable of following instructions during the procedure.
Performing PillCam Capsule Endoscopy
Real-Time Viewing with PillCam Recorder DR2 Only— External Mode 87
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.
Real-Time Viewing with PillCam Recorder DR2 Only—
External Mode
To activate real-time viewing with external RAPID Real-Time viewer, connect either PillCam recorder
model you are using to the external real-time viewer through the respective USB cable and activate the
RAPID Real-Time viewer. For instructions on the operation of the RAPID Real-Time viewer, see the
user manual for RAPID Real-Time viewer.
Removing Equipment from the Patient
If the patient has not already removed equipment, do so as follows:
1. Disconnect the sensors from the PillCam recorder.
2. Remove the PillCam recorder from the patient.
3. Remove the sensors from the patient.
4. Remove the PillCam recorder from the pouch and place it in the cradle.
5. After each procedure, make sure to clean the equipment (see PillCam Sensor Cleaning on
page 205) and charge the PillCam recorder (see Charging on page 203).
֠
֠֠
֠Note
AFR should be activated only after visually confirming entry into the small
bowel
PillCam Capsule Endoscopy
88 Removing Equipment from the Patient
PillCam Recorder Download 89
Chapter 7
Creating RAPID Videos
PillCam Recorder Download
After the capsule endoscopy examination, the video data in the PillCam recorder must be copied to a
computer and compiled into a video. There are two ways of doing this:
•Copy the data and compile the video as a single task. This method is the default; it is very
convenient, but takes longer to complete and free up the PillCam recorder.
•Copy the data only and perform compilation later. This method requires some additional steps, but
makes the PillCam recorder available faster (see Copying Data from a PillCam Recorder on
page 93).
When creating a video, the RAPID software:
•Creates a folder for the new video. This folder is inside the preset default folder (see RAPID Video
Files on page 143).
•Displays the images being copied from the PillCam recorder during video creation.
•Creates the RAPID video from this raw data and saves it in the new folder. The new video name and
its folder name are the same.
•Notifies you once video creation is complete so you may disconnect the PillCam recorder.
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֠Note
• In the rare case that the video creation fails, RAPID prompts you to save the
raw data for customer support.
• You can reduce the file size while copying data (see Video Data
Management Section on page 174).
• When downloading from four recorders simultaneously ensure that there is
at least to 40 gigabytes of hard disk space.
• Make sure that the computer power settings are not set to sleep or to
hibernate modes.
!
Caution
Connection of the PillCam recorder to the RAPID software for patient check-in,
video download, and recorder upgrade must be done using the appropriate
cradle.
PillCam Capsule Endoscopy
90 PillCam Recorder Download
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. Click the Recorder bar that corresponds to the PillCam recorder with the desired data:
• When the correct Recorder bar is activated and you click on the Identify Recorder button, the
corresponding PillCam recorder LEDs blink.
• The relevant patient information is displayed on the Recorder bar.
• PillCam recorder's last use, such as Recording, Creating video...
The Create Video and Check-in Patient buttons become available.
4. Click Create Video.
Creating RAPID Videos
PillCam Recorder Download 91
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.
• The Do not remove recorder message flashes below the battery status until all data is
copied or compiled into a video.
The images that are being copied to the computer are displayed in the Compiling Images window
above the function buttons.
Creating a Video from USB Storage Device or DVD
RAPID supports video creation from media (a removable USB storage device or DVD). This can be
useful if you have cop