pillcam_capsule_endoscopy_user_manual_rapid_v_8-0_m.pdf
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®
PillCam
Capsule Endoscopy
User Manual
RAPID® v8.0
DOC-2044-02
March 2013
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COPYRIGHT
Copyright ©2001–2013 Given Imaging Ltd.
TRADEMARKS
Copyright ©2001–2013 Given Imaging Ltd. GIVEN, GIVEN & Design, PILLCAM, PILLCAM & Logo, PILLCAM EXPRESS, AGILE, RAPID,
RAPID ACCESS, ICCE, ICCE Logos, International Conference on Capsule Endoscopy, BRAVO, BRAVO PH SYSTEM, VUESPAN, VERSAFLEX,
GEROFLEX, REPHLUX TRACER, GASTROTRAC, BILITEC, DIGITRAPPER, PHERSAFLEX, MANOSCAN, MANOSHIELD, MANOVIEW,
ACCUTRAC, ACCUVIEW, and POLYGRAF ID are Trademarks and/or Registered Trademarks of Given Imaging Ltd., its subsidiaries and/or
affiliates in the United States and/or other countries. All other company or product names are the trademarks or registered trademarks of their
respective holders. All rights not expressly granted are reserved.
This device complies with Part 15 of the FCC rules. Operation is subject to the following two conditions: (1) this device may not cause harmful
interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
֠
Note
Changes or modifications not expressly approved by Given Imaging Limited
could void authority to operate the PillCam Capsule Endoscopy System.
Rx Only
Given Imaging
3950 Shackleford Road, Suite 500 Duluth GA
30096 USA supportUS@givenimaging.com
Given Imaging GmbH
Borsteler Chaussee 47 D-22453
Hamburg, Germany supportEU@givenimaging.com
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Table of Contents
Chapter 1
Using This Guide .......................................................................................... 1
Conventions ............................................................................................................................. 1
Chapter 2
Indications, Contraindications, Warnings, Cautions ................................ 3
Indications for Use................................................................................................................... 3
Contraindications .................................................................................................................... 4
Adverse Events ........................................................................................................................ 5
Warnings................................................................................................................................... 5
Cautions.................................................................................................................................... 7
Benefits and Risks—PillCam Capsule Endoscopy............................................................... 8
Accuracy of the Device—SB................................................................................................... 9
Accuracy of the Device—ESO .............................................................................................. 10
Accuracy of the Device—COLON......................................................................................... 11
Chapter 3
Welcome to PillCam Capsule Endoscopy ................................................ 13
What is PillCam Capsule Endoscopy? ................................................................................
The PillCam Capsule Endoscopy Process ..........................................................................
PillCam Capsule Endoscopy System Components............................................................
PillCam Capsules..............................................................................................................
Handling the PillCam Capsule ..........................................................................................
PillCam Recorders ............................................................................................................
PillCam Sensors ...............................................................................................................
RAPID for PillCam Software .............................................................................................
13
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Chapter 4
Preparing for PillCam Capsule Endoscopy ............................................. 19
Preparing the Patient.............................................................................................................
Preparing the Required Equipment......................................................................................
Connecting the PillCam Recorder to RAPID.....................................................................
Creating Patient Instructions for the Procedure.................................................................
Pre-ingestion Instruction Handouts...................................................................................
Post-ingestion Instructions for Colon Procedure...............................................................
General Patient Guidelines During the Procedure .............................................................
Performing Patient Check-in.................................................................................................
Update Patient Details ......................................................................................................
Fitting Equipment on the Patient..........................................................................................
Applying the PillCam Sensor Belt .....................................................................................
Applying the PillCam Sensor Array...................................................................................
Attaching the Sensors to PillCam Recorder......................................................................
Given Imaging
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PillCam Capsule Endoscopy
Chapter 5
Know Your PillCam Recorder ....................................................................43
Preparing the PillCam Recorder ..........................................................................................
Functions ...............................................................................................................................
Initialization.......................................................................................................................
Pairing ..............................................................................................................................
Real-Time Viewing ...........................................................................................................
Regimen Reminder ..........................................................................................................
Download .........................................................................................................................
PillCam Recorder DR3 ..........................................................................................................
General.............................................................................................................................
Turning On and Off...........................................................................................................
Regimen Reminder ..........................................................................................................
Charging...........................................................................................................................
Controls ............................................................................................................................
PillCam Recorder DR2 ..........................................................................................................
General.............................................................................................................................
Turning On and Off...........................................................................................................
Charging...........................................................................................................................
PillCam Recorder DR2 LEDs ...........................................................................................
Connecting a PillCam Recorder to a Personal
Computer (PC) .......................................................................................................................
Connecting a PillCam Recorder to the External
Real-Time Viewer...................................................................................................................
43
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56
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Chapter 6
Performing PillCam Capsule Endoscopy .................................................57
Setting Delay First Instruction in PillCam Recorder ..........................................................
PillCam Recorder-Capsule Pairing (DR3 only) ...................................................................
Capsule Designation During Patient Check-in .................................................................
Capsule Designation Before Capsule Ingestion...............................................................
Capsule Ingestion .................................................................................................................
PillCam Recorder DR3 .....................................................................................................
PillCam Recorder DR2 .....................................................................................................
After Capsule Ingestion ........................................................................................................
PillCam ESO ....................................................................................................................
PillCam SB .......................................................................................................................
PillCam COLON (DR3 only) .............................................................................................
Real-Time Viewing with PillCam Recorder DR3 Only—Internal Mode .............................
Real-Time Viewing with PillCam Recorder DR2 Only—
External Mode........................................................................................................................
Removing Equipment from the Patient ...............................................................................
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Table of Contents
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PillCam Capsule Endoscopy
Chapter 7
Creating RAPID Videos .............................................................................. 67
PillCam Recorder Download.................................................................................................
Creating a Video from the PillCam Recorder....................................................................
Creating Video from USB Storage Device or DVD ...........................................................
Batch Video Creation ........................................................................................................
Pause/End Video Creation................................................................................................
Managing RAPID Video Data ................................................................................................
Copy Data from a PillCam Recorder.................................................................................
Managing Data Files .........................................................................................................
Batch Data Copy...............................................................................................................
Backing up Data................................................................................................................
67
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73
Chapter 8
Reviewing and Interpreting RAPID Videos .............................................. 75
Loading a Study with the Study Manager............................................................................ 75
Archives ............................................................................................................................ 76
Studies .............................................................................................................................. 78
Understanding the Status Bar........................................................................................... 78
Action Buttons................................................................................................................... 79
Search Function................................................................................................................ 79
Managing Columns ........................................................................................................... 81
Using the Study Manager...................................................................................................... 83
Open ................................................................................................................................. 83
Export................................................................................................................................ 83
Delete................................................................................................................................ 87
Offline Studies................................................................................................................... 88
Overview of the RAPID Interface .......................................................................................... 89
Dialog Box Launchers....................................................................................................... 89
Quick Access Toolbar ....................................................................................................... 90
File View ........................................................................................................................... 91
View Screen...................................................................................................................... 92
View Ribbon...................................................................................................................... 93
Using RAPID to View a Video ............................................................................................... 99
Reading a Capsule Endoscopy Video .............................................................................. 99
Viewing a Video .............................................................................................................. 101
Dual Head View .............................................................................................................. 101
SBI View ........................................................................................................................ 102
Time Bar/Color Bar ......................................................................................................... 102
Creating and Annotating Thumbnails.............................................................................. 103
Using Localization and Landmarks ................................................................................. 109
Comparing Thumbnails................................................................................................... 112
RAPID Video Files................................................................................................................ 114
Working with Findings ........................................................................................................ 115
Saving Your Findings...................................................................................................... 115
Opening a Findings File .................................................................................................. 115
Creating a PillCam Capsule Endoscopy Report ............................................................... 116
Overview ......................................................................................................................... 116
Report Ribbon................................................................................................................. 117
Given Imaging
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PillCam Capsule Endoscopy
RAPID Atlas .........................................................................................................................
Comparing Video Images to Atlas Images .....................................................................
Atlas Image Export .........................................................................................................
Lewis Score .........................................................................................................................
Generating a Report............................................................................................................
Image Data Buttons Group.............................................................................................
121
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126
127
Appendix A1
Installing RAPID Software ........................................................................131
Setup Requirements ...........................................................................................................
RAPID Installation ...............................................................................................................
Main Endoscopy System Components .............................................................................
Connecting the Components .............................................................................................
Connecting the PillCam Recorder Cradle .........................................................................
Starting RAPID for the First Time ......................................................................................
131
131
132
132
132
133
Appendix A2
Configuring RAPID Software ...................................................................135
Single or Multi-user Setting................................................................................................
RAPID Workstation Configuration ..................................................................................
RAPID Settings ....................................................................................................................
General Tab ...................................................................................................................
Video Tab .......................................................................................................................
Report Tab .....................................................................................................................
Check-In Tab..................................................................................................................
Other Tab .......................................................................................................................
Regimen Manager ...............................................................................................................
Using the Regimen Manager..........................................................................................
Pre-Ingestion Patient Instructions ..................................................................................
Post-Ingestion Patient Instructions.................................................................................
To Print the Patient Instructions .....................................................................................
Print Layout of the Post-Capsule Ingestion Instructions.................................................
Additional Settings..............................................................................................................
Backup/Restore Offline Studies .....................................................................................
Importing Reports...........................................................................................................
Freeing Space on Your Computer..................................................................................
Backup System Logs......................................................................................................
CD/DVD Burning ............................................................................................................
Keyboard Shortcuts ............................................................................................................
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Table of Contents
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PillCam Capsule Endoscopy
Appendix A3
PillCam Equipment Maintenance ............................................................ 163
PillCam Recorder Maintenance ..........................................................................................
Important Safety Instructions ..........................................................................................
PillCam Recorder DR3....................................................................................................
PillCam Recorder DR2....................................................................................................
PillCam Sensor Maintenance..............................................................................................
Cleaning the PillCam Sensor Belt...................................................................................
Cleaning the PillCam Sensor Array ................................................................................
Cleaning the Recorder Pouch.........................................................................................
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167
Appendix A4
Troubleshooting ....................................................................................... 169
RAPID Video .........................................................................................................................
Saving and Opening Video .................................................................................................
Printer ...................................................................................................................................
CD/DVD .................................................................................................................................
Sensor Array ........................................................................................................................
Sensor Belt ...........................................................................................................................
Capsule .................................................................................................................................
Cradle....................................................................................................................................
PillCam Recorder DR3.........................................................................................................
PillCam Recorder DR2.........................................................................................................
Error Messages ....................................................................................................................
Low Signal ............................................................................................................................
169
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Appendix A5
Technical Description .............................................................................. 175
System Labeling ..................................................................................................................
Capsule Labeling ............................................................................................................
Essential Performance ........................................................................................................
PillCam Capsules............................................................................................................
PillCam Recorder DR2 and PillCam Recorder DR3 .......................................................
Warnings...............................................................................................................................
Cautions................................................................................................................................
System Specifications.........................................................................................................
PillCam SB Capsule........................................................................................................
PillCam SB 2 Capsule.....................................................................................................
PillCam SB 3 Capsule.....................................................................................................
PillCam ESO 2 Capsule..................................................................................................
PillCam ESO 3 Capsule..................................................................................................
PillCam COLON Capsule................................................................................................
PillCam COLON 2 Capsule.............................................................................................
Sensor Array PillCam Recorder DR2..............................................................................
Sensor Array PillCam Recorder DR3..............................................................................
PillCam Recorder DR2 /2C ............................................................................................
Cradle PillCam Recorder DR2 ........................................................................................
PillCam Recorder DR3 ...................................................................................................
Given Imaging
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PillCam Capsule Endoscopy
PillCam Recorder DR3 SDHC Memory Card .................................................................
Cradle PillCam Recorder DR3 .......................................................................................
DC Power Supply ...........................................................................................................
RAPID for PillCam Software...........................................................................................
Guidance and Manufacturer's Declarations .....................................................................
PillCam Capsules (No PillCam COLON 2).....................................................................
PillCam COLON 2 Capsules ..........................................................................................
PillCam Recorder DR2(C) .............................................................................................
PillCam Recorder DR3 ..................................................................................................
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Index ...........................................................................................................205
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Table of Contents
Page 9
Chapter 1
Using This Guide
Conventions
Screen elements, such as menus, button names, and screen names are in bold as follows: PillCam
Recorders.
System messages appear as follows: Your PillCam recorder needs an update.
A Note is a piece of information or a remark that receives emphasis and appears as follows:
֠
Note
When connecting more than one PillCam recorder DR2 to the computer,
use a USB-powered hub.
A Caution warns you about possible damage to equipment, and appears as follows:
!
Caution
Make sure that there is no other PillCam capsule or other diagnostic capsule
in the patient’s gastrointestinal tract.
A Warning warns you about possible harm to people and appears as follows:
!
Given Imaging
Warning
Never connect the PillCam recorder to the sensor array while the PillCam
recorder is in its cradle.
1
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PillCam Capsule Endoscopy
2
Conventions
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Chapter 2
Indications, Contraindications, Warnings,
Cautions
Indications for Use
PillCam SB
The PillCam SB capsule is intended for visualization of the small bowel mucosa.
•
It may be used in the visualization and monitoring of lesions that may indicate Crohn's
disease not detected by upper and lower endoscopy.
•
It may be used in the visualization and monitoring of lesions that may be a source of obscure
bleeding (either overt or occult) not detected by upper and lower endoscopy.
•
It may be used in the visualization and monitoring of lesions that may be potential causes of
iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of
containing blood or red areas.
The PillCam SB capsule may be used as a tool in the detection of abnormalities of the small
bowel and is intended for use in adults and children from two years of age.
PillCam ESO
The PillCam Capsule Endoscopy System with PillCam ESO capsules is intended for the
visualization of esophageal mucosa for diagnosis of esophageal disorders.
PillCam COLON
The PillCam Capsule Endoscopy System with the PillCam COLON capsule is intended for the
visualization of the colon for diagnosis of colonic disorders.
֠
Given Imaging
Note
The procedure may involve intake of laxatives and prokinetic agents. Refer
to the labeling of these agents for their contraindications.
3
Page 12
PillCam Capsule Endoscopy
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 preprocedure testing and profile.
•
In patients with cardiac pacemakers or other implanted electromedical devices.
•
In patients with dysphagia or other swallowing disorders.
֠
Note
• In patients who cannot ingest the capsule an acceptable alternative is to
sedate the patient and place the capsule into the duodenum using a
device such as an endoscopic basket loaded onto an upper enteroscope.
•
Placement into the duodenum is recommended to prevent the patient
from vomiting the capsule.
•
Pediatric patients who are physiologically mature enough to ingest
capsules can be taught by practicing with candy, starting with very small
candies and gradually introducing larger candy pieces until the patients
demonstrate the ability to swallow an object the size and shape of the
PillCam SB capsule.
PillCam ESO
The PillCam ESO capsule is contraindicated for use under the following conditions:
•
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.
֠
Note
This device is not meant to replace upper endoscopy.
PillCam COLON
The PillCam COLON capsule is contraindicated for use under the following conditions:
4
•
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.
Contraindications
Page 13
Indications, Contraindications, Warnings, Cautions
Adverse Events
Potential adverse events associated with the use of this device include delayed or no excretion of
the capsule, and aspiration. In some instances, intervention is required to remove the capsule.
Potential adverse events associated with the use of this device may include obstruction,
perforation, and mucosal injury or bleeding. Summaries in published literature identify the risk of
retention for obscure bleeding to be 1.5%, for suspected Crohn's disease to be 1.4%, for Known
Crohn's the risk is higher at 5% and for neoplastic lesions the rate of retention is 2.1% as
compared to healthy volunteers [1],[2].
References
[1] Cave et al. Endoscopy 2005; 37: 1065-1067.
[2] Zhuan et al. GI Endoscopy 2010; 71: 280-286.
Warnings
A Warning indicates a condition that may endanger the patient or the user.
•
The capsule should not be swallowed by children under the age of 8 years or by patients
where a concern for aspiration of the capsule exists [e.g. due to cognitive or neurological
deficits or a history of aspiration]. In these patients it is recommended a capsule endoscopic
delivery system is used to place the capsule directly in the duodenum. Placement of the
capsule in the duodenum will decrease the risk of aspiration of the device [by vomiting] and
gastric retention.
•
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.
•
If intestinal fistulas, strictures, or stenoses are suspected, or the patient has had prior
abdominal or pelvic surgery, the physician should consider performing a procedure to
ascertain patency for an object the size of the PillCam video capsule.
•
A thorough understanding of the technical principles, clinical applications and risks
associated with the PillCam Capsule Endoscopy System is necessary before using this
product. Read the entire manual before using the system for the first time.
•
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.
•
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.
•
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.
•
Do not use any PillCam video capsule after its expiration date.
•
Only one PillCam video capsule should be ingested at a time and only after confirmation that
no other PillCam video capsules or ingestible diagnostic devices remain in the patient’s
body.
Adverse Events
5
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PillCam Capsule Endoscopy
6
•
Instruct the patient to avoid biting the PillCam video capsule prior to swallowing.
•
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.
•
Instruct the patient to contact the physician immediately if, after ingesting any PillCam video
capsule, there is any abdominal pain, nausea, or vomiting.
•
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.
•
Instruct the patient not to sit on bare metal surfaces, such as chairs with metal seating area,
during the procedure.
•
Store all PillCam video capsules in a safe place, out of the reach of children and infants.
•
If contrary to instructions a patient ingests more than one PillCam video capsule, instruct the
patient to immediately contact the physician.
•
When swallowing the capsule there is a possibility of choking on the capsule. If the patient
exhibits any symptoms and/or clinical signs of choking (labored breathing, wheezing,
involuntary coughing, etc.), the recommended protocols should be followed.
•
If a child has accidentally swallowed any unused or spent PillCam video capsule, seek
medical attention.
•
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 postprocedure abdominal pain, vomiting, or other symptoms
of obstruction, he/she should contact the physician for evaluation and possible abdominal Xray examination.
•
Undergoing an MRI while the PillCam video capsule is inside the patient's body may result in
serious damage to his/her intestinal tract or abdominal cavity. If the patient did not positively
verify the excretion of any PillCam video capsule from his/her body, he/she should contact the
physician for evaluation and possible abdominal X-ray before undergoing an MRI
examination.
•
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.
•
The safety of the PillCam SB capsules has not been established in children below two years of
age.
•
The safety of the PillCam ESO capsule has not been established in patients below age 18.
•
The safety of the PillCam COLON capsules has not been established in patients below age 18.
•
Never connect the PillCam recorder to the sensor array while the PillCam recorder is in its
cradle.
•
Examine both video streams when viewing the results of a colon or an esophageal capsule
endoscopy.
Warnings
Page 15
Indications, Contraindications, Warnings, Cautions
•
•
•
•
PillCam Capsule Endoscopy System and its components need special precautions regarding
Electromagnetic Compatibility (EMC) to avoid loss of image transfer resulting in video
gaps. PillCam Capsule Endoscopy System needs to be installed and put into service
according to the Electromagnetic Compatibility (EMC) information provided in the
accompanying documents.
The PillCam video capsule and PillCam recorder should not be used adjacent to or stacked
with other equipment and that if adjacent or stacked use 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.
Cautions
A caution indicates a condition that may damage the equipment.
Cautions
•
Make sure that only trained personnel, familiar with all of the PillCam Capsule Endoscopy
System operating procedures, use the system.
•
Endoscopic video capsule placement requires skill and experience in endoscopic esophageal
intubations with an accessory device seated at the distal tip of the endoscope. Use of the
device is not recommended if the clinician lacks the required experience and proficiency.
•
Use the system only with components purchased from Given Imaging Ltd. Use of other
components including power supply for the cradle, may damage the system and void the
warranty.
•
Occasionally, some images may be lost (resulting in video gaps) due to radio interference
(e.g., from amateur radio transmitters, RFID (radio-frequency identification) systems, MRI,
fire station , police station etc.). This may result in the need to repeat the Capsule Endoscopy
procedure. In such a case, advise the patient to stay within the premises of the clinic for the
duration of the second Capsule Endoscopy procedure to prevent this problem from recurring.
•
In a small number of cases, the PillCam SB capsules used for Small Bowel Capsule
Endoscopy may not image the entire small bowel due to variations in patient GI motility.
Similarly the PillCam COLON capsule used for COLON Capsule Endoscopy may not image
the entire large bowel (colon) due to variations in 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.
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PillCam Capsule Endoscopy
Benefits and Risks—PillCam Capsule Endoscopy
Benefits
•
PillCam® capsule endoscopy is the most widely used patient-friendly tool for visualization of
the GI tract. To date, more than 1,700,000 patients worldwide have benefited from PillCam
endoscopy.
•
After the patient swallows the PillCam video capsule, images and data are transmitted
wirelessly as the capsule passes through the digestive system. The images are captured and
stored in a PillCam recorder worn by the patient; after the procedure is complete the images
are reviewed by a physician.
•
PillCam capsule endoscopy offers a simple, safe and non-invasive alternative to traditional
imaging procedures. The procedure does not require sedation, intubation, bowel insufflation
or radiation. Patients may continue with their normal daily activity during the procedure.
•
The PillCam patency capsule provides a simple and convenient means to verify functional
patency of the GI tract in patients with known or suspected strictures.
Risks
8
•
PillCam capsule endoscopy is not for everyone. PillCam video capsules are contraindicated in
patients with known or suspected gastrointestinal obstruction, strictures or fistulas, in patients
with cardiac pacemakers or other implantable electromedical devices and in patients with
swallowing disorders.
•
PillCam patency capsules are contraindicated in patients with swallowing disorders. The
PillCam patency scanner is contraindicated in patients with cardiac pacemakers or other
implanted electromedical devices.
•
Capsule retention has been reported in less than two percent of all capsule endoscopy and
patency procedures. Capsule retention is defined as having a capsule remain in the digestive
tract for more than two weeks.
•
Causes of retention cited in the literature include: NSAID strictures, Crohn's disease, small
bowel tumors, intestinal adhesions, ulcerations, and radiation enteritis. Summaries in
published literature identify the risk of retention for obscure bleeding to be 1.5%, for
suspected Crohn's disease to be 1.4%, for known Crohn's the risk is higher at 5% and for
neoplastic lesions the rate of retention is 2.1% as compared to healthy volunteers.[1],[2]. To
verify passage of the capsule from the GI tract, an abdominal X-ray may be obtained at the
discretion of the physician. The capsule can be removed using medical, endoscopic or surgical
intervention.
•
There is an extremely rare risk of capsule aspiration while patients are attempting to swallow
a PillCam video capsule or PillCam patency capsule. There is also a low risk of skin irritation
from the sensor array sleeve adhesive or silicone exposure.
•
The PillCam SB video capsule and/or the PillCam patency capsule may be administered by
using transendoscopic delivery in patients who are either unable to ingest the capsule or are
known to have slow gastric emptying time. If using transendoscopic delivery potential
complications include, but are not limited to: perforation, hemorrhage, aspiration, fever,
infection, hypertension, respiratory arrest, cardiac arrhythmia or arrest.
•
All medical procedures carry some risks. Information in this manual should not be used as a
substitute for talking with your doctor about diagnosis and treatment.
Benefits and Risks—PillCam Capsule Endoscopy
Page 17
Indications, Contraindications, Warnings, Cautions
References
[1] Cave et al. Endoscopy 2005; 37: 1065-1067.
[2] Zhuan et al. GI Endoscopy 2010; 71: 280-286.
Accuracy of the Device—SB
The PillCam Capsule Endoscopy System with the PillCam SB capsule was studied in a series of
20 subjects with hemoccult positive stool, iron-deficiency anemia, and/or subacute hematochezia
or melena. All patients had undergone unrevealing colonoscopy, gastroscopy, enteroscopy, and
small bowel x-rays prior to enrolling in the study. When compared to repeated push enteroscopy,
the PillCam video capsule was able to detect a pathological abnormality in 12 (60%) of the
patients whereas enteroscopy detected abnormalities in 7 (35%) of these patients. The 5 patients
in whom lesions were found by the PillCam video capsule but not enteroscopy all had
abnormalities in the distal jejunum or ileum, outside the reach of most standard enteroscopy
examinations. The average length of insertion during enteroscopy was 2.3 meters. Specific
findings detected by the imaging system included arterio-venous malformations (AVMs),
mucosal erosions and ulcerations, and a submucosal tumor. In one case (5%), though the PillCam
video capsule detected a small bowel AVM that was found by enteroscopy, one out of the two
reviewing physicians did not detect the AVM when reviewing the RAPID video.
Overall, the findings obtained from the PillCam Capsule Endoscopy System and standard
enteroscopy agreed in 14 cases (70%). The two methods revealed similar pathologies in 6 of these
patients. Both exams were normal in an additional 8 patients.
A total of 14 separate small bowel findings were eventually noted in 13 patients by either of the
two imaging modalities or by laparoscopic surgery. The PillCam Capsule Endoscopy System was
able to identify 12 of the 14 lesions (86%) while the enteroscopy detected 7 of the 14 lesions
(50%). Both repeated enteroscopies, small bowel x-rays and the PillCam video capsule, failed to
detect an ulcerated Meckel’s diverticulum found at surgery.
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).
The localization software was studied in a series of 17 healthy subjects. Multiple fluoroscopic
images (92 sets) were obtained at various times during the PillCam video capsule's passage
through the small bowel. The location was assessed in two dimensions relative to the umbilicus
and then compared to the position obtained from the localization software. When compared to the
relative two-dimensional location determined fluoroscopically, approximately 87% (80/92) of the
PillCam video capsule estimates were within 6cm (a “fist”). The mean error for PillCam video
capsule localization was found to be 3.8 cm.
The Suspected Blood Indicator (SBI) feature is intended to mark frames suspected of containing
fresh blood. The feature may be activated only after labeling the first duodenal image and marks
frames contained only within the small bowel. The SBI feature should not serve as a substitute for
a physician's complete viewing of the video but rather to provide supplemental information
afterwards. All events marked by the SBI feature should be carefully reviewed by a physician. In
a review of 27 patients with at least one red or bleeding lesion found by a physician on capsule
endoscopy, the SBI feature correctly marked 439, or 88%, of the 498 individual lesions. In
addition, a total of 561 false positive lesions were marked by the feature, giving a positive
predictive value (PPV) of 44%.
Accuracy of the Device—SB
9
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PillCam Capsule Endoscopy
Accuracy of the Device—ESO
The PillCam Capsule Endoscopy System with the PillCam ESO capsule was studied in a series of
107 subjects included in the study. Among patients included in this clinical study, 94 subjects had
suspected GERD at the time of the study, and a small group (13 subjects) were diagnosed with
Barrett’s prior to the study.
All patients underwent esophageal capsule endoscopy as well as esophagoscopy, to compare the
results of the esophageal capsule endoscopy with conventional video EGD (imperfect standard) in
assessing endoscopic findings of the esophagus.
Rate of
Agreement
(95% CI)
Rate of False
Pos (95% CI)
Rate of False
Neg (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
Agreement
(95% CI)
OVERALL
78.3%
(69%; 86%)
The study was too small to accurately assess the agreement with lesions other than the most
common findings—esophagitis and suspected Barrett’s esophagus. There were several other
lesions which were noted as depicted in the table below.
# 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%
֠
10
Note
The PillCam ESO capsule was not able to reliably identify:
• Precise location of lesion(s)
•
Length or extent of lesion(s)
•
Severity or grade of lesion(s)
Accuracy of the Device—ESO
Page 19
Indications, Contraindications, Warnings, Cautions
Accuracy of the Device—COLON
A combined analysis of three studies performed on patients with suspected colonic polyps was
performed. It includes 202 patients who underwent both PillCam COLON 2 capsule endoscopy
(PCE) and conventional colonoscopy. The studies were designed to assess the detection of
colonic polyps. The accuracy parameters for PCE, in detecting patients with polyps > 6mm and
polyps > 10mm, were evaluated against colonoscopy which was considered as the gold standard.
Results are presented in the table hereafter:
Sensitivity
(95% CI)
Polyp size
Specificity
(95% CI)
> 6 mm
84 (77-90)
79 (74-82)
> 10 mm
82 (72-88)
94 (91-96)
Capsule endoscopy of the PillCam COLON 2 system appears to show good sensitivity and
specificity for detecting patients with polyps > 6 mm and > 10 mm.
Accuracy of the Device—COLON
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PillCam Capsule Endoscopy
12
Accuracy of the Device—COLON
Page 21
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 recorder with PillCam sensors, which receives and stores 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.
There are three PillCam capsule types, supported by the current PillCam endoscopy system. Each
is optimized for a different bowel segment, some with one video head and some with two video
heads:
Given Imaging
13
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PillCam Capsule Endoscopy
PillCam SB capsules:
small bowel
PillCam ESO capsules:
esophagus
PillCam COLON capsule:
colon
PillCam SB capsules contain one video camera. PillCam SB2 is a fixed frame rate second
generation capsule, while PillCam SB3 is a third generation capsule with enhanced imaging
capabilities with adaptive frame rate (AFR).
PillCam ESO capsules contain two video cameras (one at each end). They also have two variants:
PillCam ESO 2 fixed high frame rate and PillCam ESO 3 with enhanced imaging capabilities and
fixed high frame rate.
PillCam COLON capsules contain two video cameras (one at each end). The PillCam COLON 1
variant is a fixed frame rate capsule while the PillCam COLON 2 variant is an enhanced imaging
capability adaptive frame rate (AFR) variant.
After activation and ingestion, the capsule is propelled by peristalsis through the gastrointestinal
tract. During this process, the video cameras acquire images and the transmitter sends them, via the
sensors, to the PillCam recorder for storage.
For full technical specifications of PillCam capsules, see System Specifications on page 179. For
indications and contraindications, see Indications, Contraindications, Warnings, Cautions on
page 3.
!
Caution
The PillCam capsule transmits at a specific frequency of 434.1MHz 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.
•
14
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 Capsule Endoscopy System Components
Page 23
Welcome to PillCam Capsule Endoscopy
Handling the PillCam Capsule
PillCam capsules are packaged using a controlled process that ensures the capsule is activated
only when needed. Each PillCam capsule is packed in a separate box with an embedded magnet
that prevents it from activating when it is handled in the box prior to ingestion.
To avoid accidental activation (blinking) of the capsule while in its box, please observe the
following:
!
Caution
• Keep the PillCam capsules in their box until use.
•
Store the PillCam capsules only in packaging supplied with the product.
•
Do not use a PillCam capsule if 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 COLON 2 procedures: After ingesting the PillCam colon capsule
instruct the patient not to sit on bare metal surfaces, such as chairs with
metal sitting area, during the procedure.
PillCam Recorders
The PillCam recorder is a compact battery-operated unit worn by the patient during the
procedure.
It receives and stores the image data transmitted by the PillCam capsule. There are two models
currently available: PillCam recorder DR3 and PillCam recorder DR2.
The PillCam recorder is supplied with a pouch to wear over the shoulder and with an adjustable
strap to secure to the waist.
DR2
DR3
PillCam Sensors
The PillCam sensors are physical receptors that receive transmission data from the PillCam
capsule and transfer it to the PillCam recorder. These sensors are placed on the patient as a
sensor belt or a sensor array.
PillCam sensor belt: The sensor belt is worn around the patient’s waist over a thin shirt.
PillCam Capsule Endoscopy System Components
15
Page 24
PillCam Capsule Endoscopy
PillCam sensor array: The sensors of the sensor array are attached to the patient's skin. The
locations depend on the procedure type. Each sensor is built of a flexible printed circuit board
(PCB) and is attached with a disposable, medical adhesive sleeve.
The PillCam sensor array and belt are connected to the PillCam recorder by a flexible cable.
֠
Note
The PillCam Capsule Endoscopy System does not contain any natural
rubber latex components.
RAPID for PillCam Software
Version v8 of the RAPID for PillCam software (RAPID v8) supports the procedure by providing
access to the different steps in PillCam capsule endoscopy. Access to the different steps in the
procedure is provided by using the Home screen.
The Home Screen
After starting the RAPID v8 software, the Home screen appears. The Home screen is the main
screen that provides access to all phases of the PillCam capsule endoscopy procedure.
The Home screen enables the following functions:
• 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 75)
1
2
3
4
5
֠
16
6
Note
Certain key functions described in this manual are accessed from the Home
screen. All future mention of Home screen, such as From the Home screen
click the Tools button refers to the screen described above.
PillCam Capsule Endoscopy System Components
Page 25
Welcome to PillCam Capsule Endoscopy
1
2
3
4
Patient Check-in: opens the patient check-in wizard to enter information about
the patient and the procedure and to initialize the PillCam recorder with this data.
There are a series of screens that walk you through the check-in process (see
Performing Patient Check-in on page 24).
Recorder Download: opens a screen to download data from a PillCam recorder
(see PillCam Recorder Download on page 67) and to create a RAPID video from
the data.
View 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 83).
• 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.
Tools: clicking this button opens a menu that provides access to:
• Regimen Manager: opens a software tool for creating or modifying capsule
ingestion regimen instructions for the patient (see Regimen Manager on
page 148).
• Settings: enables user configuration of RAPID settings (see RAPID Settings
on page 136).
• Atlas: opens an atlas of typical disease images searchable by key descriptors
and used as a viewing aid for comparing study images with reference images
(see RAPID Atlas on page 121).
• Delete Videos: Delete a RAPID video folder and its contents (see Freeing
Space on Your Computer on page 159).
• User Dictionary: Import or export term dictionary used in writing comments
and study summary.
PillCam Capsule Endoscopy System Components
17