pillcam_capsule_endoscopy_user_manual_rapid_v_8-0_j.pdf
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®
PillCam
Capsule Endoscopy
User Manual
RAPID® v8.0
DOC-2043-03
July 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
PillCam SB .......................................................................................................................... 3
PillCam ESO ....................................................................................................................... 3
Contraindications..................................................................................................................... 4
PillCam SB .......................................................................................................................... 4
PillCam ESO ....................................................................................................................... 4
Adverse Events ........................................................................................................................ 4
Warnings................................................................................................................................... 5
Cautions.................................................................................................................................... 7
Benefits and Risks—PillCam Capsule Endoscopy............................................................... 7
Benefits ............................................................................................................................... 7
Risks ................................................................................................................................... 8
Essential Performance ............................................................................................................ 8
PillCam Video Capsules...................................................................................................... 8
PillCam Recorder DR2 and PillCam Recorder DR3 ........................................................... 9
Accuracy of the Device—SB 1 ................................................................................................ 9
Accuracy of the Device—ESO 1 ........................................................................................... 10
Chapter 3
Welcome to PillCam Capsule Endoscopy ................................................ 13
What is PillCam Capsule Endoscopy?................................................................................. 13
The PillCam Capsule Endoscopy Process .......................................................................... 13
PillCam Capsule Endoscopy System Components............................................................ 13
PillCam Capsules.............................................................................................................. 13
Handling the PillCam Capsule .......................................................................................... 14
PillCam Recorders ............................................................................................................ 15
PillCam Sensors................................................................................................................ 15
RAPID for PillCam Software ............................................................................................. 16
Chapter 4
Preparing for PillCam Capsule Endoscopy ............................................. 19
Preparing the Patient ............................................................................................................. 19
Preparing the Required Equipment...................................................................................... 20
Connecting the PillCam Recorder to RAPID..................................................................... 20
Creating Patient Instructions for the Procedure ................................................................. 22
Pre-ingestion Instruction Handouts ................................................................................... 22
Given Imaging
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PillCam Capsule Endoscopy
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 .....................................................................
22
23
30
30
30
31
35
Chapter 5
Know Your PillCam Recorder ....................................................................41
Preparing the PillCam Recorder ..........................................................................................
Functions ...............................................................................................................................
Initialization.......................................................................................................................
Pairing ..............................................................................................................................
Real-Time Viewing ...........................................................................................................
Download .........................................................................................................................
PillCam Recorder DR3 ..........................................................................................................
General.............................................................................................................................
Turning On and Off...........................................................................................................
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...................................................................................................................
41
41
41
41
41
42
42
42
42
43
44
50
50
50
51
51
53
53
Chapter 6
Performing PillCam Capsule Endoscopy .................................................55
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 .......................................................................................................................
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 ...............................................................................
ii
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55
56
57
58
58
59
59
59
60
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61
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Chapter 7
Creating RAPID Videos .............................................................................. 63
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................................................................................................................
63
64
65
66
66
66
67
68
69
70
Chapter 8
Reviewing and Interpreting RAPID Videos .............................................. 71
Loading a Study with the Study Manager............................................................................ 71
Archives ............................................................................................................................ 72
Studies .............................................................................................................................. 74
Understanding the Status Bar........................................................................................... 75
Action Buttons................................................................................................................... 75
Search Function................................................................................................................ 76
Managing Columns ........................................................................................................... 77
Using the Study Manager...................................................................................................... 80
Open ................................................................................................................................. 80
Export................................................................................................................................ 80
Delete................................................................................................................................ 84
Offline Studies................................................................................................................... 85
Overview of the RAPID Interface .......................................................................................... 86
Dialog Box Launchers....................................................................................................... 86
Quick Access Toolbar ....................................................................................................... 87
File View ........................................................................................................................... 88
View Screen...................................................................................................................... 89
View Ribbon...................................................................................................................... 90
Using RAPID to View a Video ............................................................................................... 96
Reading a Capsule Endoscopy Video .............................................................................. 96
Viewing a Video ................................................................................................................ 98
Dual Head View ................................................................................................................ 98
SBI View .......................................................................................................................... 99
Time Bar/Color Bar ......................................................................................................... 100
Creating and Annotating Thumbnails.............................................................................. 101
Using Localization and Landmarks ................................................................................. 106
Comparing Thumbnails................................................................................................... 109
RAPID Video Files................................................................................................................ 111
Working with Findings ........................................................................................................ 111
Saving Your Findings...................................................................................................... 112
Opening a Findings File .................................................................................................. 112
Creating a PillCam Capsule Endoscopy Report ............................................................... 113
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PillCam Capsule Endoscopy
Overview ........................................................................................................................
Report Ribbon ................................................................................................................
RAPID Atlas .........................................................................................................................
Comparing Video Images to Atlas Images .....................................................................
Atlas Image Export .........................................................................................................
Lewis Score .........................................................................................................................
Generating a Report............................................................................................................
Image Data Buttons Group.............................................................................................
113
115
118
120
121
121
124
126
Appendix A1
Installing RAPID Software ........................................................................129
Setup Requirements ..........................................................................................................
RAPID Installation ...............................................................................................................
Main Endoscopy System Components .............................................................................
Connecting the Components .............................................................................................
Connecting the PillCam Recorder Cradle .........................................................................
Starting RAPID for the First Time ......................................................................................
129
129
130
130
130
131
Appendix A2
Configuring RAPID Software ...................................................................133
Single or Multi-user Setting................................................................................................
RAPID Workstation Configuration ..................................................................................
RAPID Settings ....................................................................................................................
General Tab ...................................................................................................................
Video Tab .......................................................................................................................
Report Tab .....................................................................................................................
Check-In Tab..................................................................................................................
Other Tab .......................................................................................................................
Additional Settings..............................................................................................................
Backup/Restore Offline Studies .....................................................................................
Importing Reports...........................................................................................................
Freeing Space on Your Computer..................................................................................
Backup System Logs......................................................................................................
CD/DVD Burning ............................................................................................................
Keyboard Shortcuts ............................................................................................................
133
133
134
135
137
139
143
144
146
146
148
148
150
150
152
Appendix A3
PillCam Equipment Maintenance .............................................................153
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................................................................................
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153
154
155
157
157
157
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Cleaning the Recorder Pouch......................................................................................... 157
Appendix A4
Troubleshooting ....................................................................................... 159
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 ............................................................................................................................
159
159
160
160
160
161
161
161
161
162
163
163
Appendix A5
Technical Description .............................................................................. 165
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..................................................................................................
Sensor Array PillCam Recorder DR2..............................................................................
Sensor Array PillCam Recorder DR3..............................................................................
PillCam Recorder DR2 /2C ............................................................................................
Cradle PillCam Recorder DR2 ........................................................................................
PillCam Recorder DR3 ...................................................................................................
PillCam Recorder DR3 SDHC Memory Card..................................................................
Cradle PillCam Recorder DR3 ........................................................................................
DC Power Supply............................................................................................................
RAPID for PillCam Software ...........................................................................................
Guidance and Manufacturer's Declarations ......................................................................
PillCam Capsules............................................................................................................
PillCam Recorder DR2(C) ..............................................................................................
165
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PillCam Capsule Endoscopy
PillCam Recorder DR3 .................................................................................................. 185
....................................................................................................................189
Index ...........................................................................................................189
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Chapter 1
Using This Guide
Conventions
Screen elements, such as menus, button names, and screen names are in bold as follows: PillCam
Recorders.
System messages appear as follows: Your PillCam recorder needs an update.
A Note is a piece of information or a remark that receives emphasis and appears as follows:
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.
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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 Capsule Endoscopy System with a PillCam SB capsule is intended for visualization of the
small bowel mucosa.
•
PillCam Capsule Endoscopy System with PillCam SB capsule may be used in the visualization and
monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
•
PillCam Capsule Endoscopy System with 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.
•
PillCam Capsule Endoscopy System with 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 a PillCam ESO capsule is intended for the visualization of
esophageal mucosa for diagnosis of esophageal disorders.
Given Imaging
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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 pre-procedure 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.
Adverse Events
Potential adverse events associated with the use of this device 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.
4
Contraindications
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Indications, Contraindications, Warnings, Cautions
Warnings
Procedure Related:
Warnings
•
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 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 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
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.
•
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 Pill-Cam
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.
•
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.
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PillCam Capsule Endoscopy
•
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.
•
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.
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.
•
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.
•
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.
Recorder Related:
6
•
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.
Warnings
Page 15
Indications, Contraindications, Warnings, 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 (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.
•
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
Cautions
•
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.
•
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.
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PillCam Capsule Endoscopy
Risks
•
PillCam capsule endoscopy is not for everyone. PillCam video capsules are contraindicated in patients
with known or suspected gastrointestinal obstruction, strictures or fistulas, in patients with cardiac
pacemakers or other implantable electromedical devices and in patients with swallowing disorders.
•
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
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.
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Essential Performance
Page 17
Indications, Contraindications, Warnings, Cautions
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
2 and PillCam Recorder DR3.
Accuracy of the Device—SB 1
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 arteriovenous 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).
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
Accuracy of the Device—SB 1
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PillCam Capsule Endoscopy
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
Accuracy of the Device—ESO 1
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]
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
10
Overall
Agreement
(95% CI)
78.3%
(69%; 86%)
Accuracy of the Device—ESO 1
Page 19
Indications, Contraindications, Warnings, Cautions
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%
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)
Reference:
[1] Clinical report presented in K041149
Accuracy of the Device—ESO 1
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PillCam Capsule Endoscopy
12
Accuracy of the Device—ESO 1
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 two 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 SB capsules contain one video camera. PillCam SB2 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 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.
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 169. 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.
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:
14
PillCam Capsule Endoscopy System Components
Page 23
Welcome to PillCam Capsule Endoscopy
!
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.
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 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.
PillCam Capsule Endoscopy System Components
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PillCam Capsule Endoscopy
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 71)
•
•
•
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
5
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 23).
Recorder Download: opens a screen to download data from a PillCam recorder (see
PillCam Recorder Download on page 63) 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 80).
• 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:
• Settings: enables user configuration of RAPID settings (see RAPID Settings on
page 134).
• 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 118).
• Delete Videos: Delete a RAPID video folder and its contents (see Freeing Space on
Your Computer on page 148).
• User Dictionary: Import or export term dictionary used in writing comments and study
summary.
Help: 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 144), an option to collect
analysis files and to show the RAPID log.
PillCam Capsule Endoscopy System Components
17