User's Manual
Table Of Contents
- User Manual
- RAPID® v8.3
- Table of Contents
- Chapter 1
- Using This Guide
- Chapter 2
- Indications, Contraindications, Warnings, Cautions
- Chapter 3
- Welcome to PillCam Capsule Endoscopy
- Chapter 4
- Preparing for PillCam Capsule Endoscopy
- Preparing the Patient
- Preparing the Required Equipment
- Creating Patient Instructions for the Procedure
- General Patient Guidelines During the Procedure
- Performing Patient Check-in
- Fitting Equipment on the Patient
- Chapter 5
- Know Your PillCam Recorder
- Chapter 6
- Performing PillCam Capsule Endoscopy
- Chapter 7
- Creating RAPID Videos
- Chapter 8
- Reviewing and Interpreting RAPID Videos
- Loading a Study with the Study Manager
- Using the Study Manager
- Overview of the RAPID Interface
- Using RAPID to View a Video
- RAPID Video Files
- Working with Findings
- Creating a PillCam Capsule Endoscopy Report
- RAPID Atlas
- Lewis Score
- Generating a Report
- Appendix A1
- Installing RAPID Software
- Appendix A2
- Configuring RAPID Software
- Appendix A3
- PillCam Equipment Maintenance
- Appendix A4
- Troubleshooting
- Appendix A5
- Technical Description
- System Labeling
- Essential Performance
- Warnings
- Cautions
- System Specifications
- PillCam SB 2 Capsule
- PillCam SB 3 Capsule
- PillCam UGI Capsule
- PillCam COLON 2 Capsule
- Sensor Array PillCam Recorder DR2
- Sensor Array PillCam Recorder DR3
- PillCam Recorder DR2/DR2C
- 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
- Index
Indications for Use 3
Chapter 2
Indications, Contraindications, Warnings,
Cautions
Indications for Use
PillCam SB
The PillCam Capsule Endoscopy System with the PillCam SB capsule is intended for visualization of the
small bowel mucosa.
• The PillCam Capsule Endoscopy System with the PillCam SB capsule may be used in the
visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and
lower endoscopy.
• The PillCam Capsule Endoscopy System with the PillCam SB capsule may be used in the
visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or
occult) not detected by upper and lower endoscopy.
• The PillCam Capsule Endoscopy System with the PillCam SB capsule may be used in the
visualization and monitoring of lesions that may be potential causes of iron deficiency anemia
(IDA) not detected by upper and lower endoscopy.
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of
containing blood or red areas.
The PillCam Capsule Endoscopy System with PillCam SB capsules may be used as a tool in the
detection of abnormalities of the small bowel and is intended for use in adults and children from two
years of age.
PillCam ESO
The PillCam Capsule Endoscopy System with PillCam ESO capsules is intended for the visualization of
esophageal mucosa in adults and children from 18 years of age.
PillCam UGI
The PillCam UGI capsule endoscopy system is intended for visualization of the upper gastrointestinal
tract (esophagus, stomach, duodenum). It may be used for visualization of blood in the upper
gastrointestinal tract (esophagus, stomach, duodenum) in patients who are hemodynamically stable and
at least 18 years of age.