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
PillCam Capsule Endoscopy
4 Contraindications
PillCam COLON
The PillCam COLON 2 capsule endoscopy system is intended to provide visualization of the colon. It may
be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate
preparation, and a complete evaluation of the colon was not technically possible.
Contraindications
PillCam SB
The PillCam SB capsules are contraindicated for use under the following conditions:
• In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the
clinical picture or pre-procedure testing and profile.
• In patients with cardiac pacemakers or other implanted electromedical devices.
• In patients with dysphagia or other swallowing disorders.
PillCam ESO/PillCam UGI
The PillCam ESO/PillCam UGI capsule is contraindicated for use under the following conditions:
• In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the
clinical picture or preprocedure testing and profile.
• In patients with cardiac pacemakers or other implanted electromedical devices.
• In patients with dysphagia or other swallowing disorders.
PillCam COLON
The PillCam COLON capsule is contraindicated for use under the following conditions:
• In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the
clinical picture or pre-procedure testing and profile.
• In patients with cardiac pacemakers or other implanted electromedical devices.
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Note
The procedure may involve intake of laxatives and prokinetic (“push”)
agents to aid in advancement of the capsule through the digestive tract.
Refer to the labeling of these agents for their contraindications.
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Note
The SB PillCam Capsule may be deployed by using transendoscopic
delivery in patients who are either unable to ingest the PillCam capsule or
are known to have slow gastric emptying time. Placement into the
duodenum is recommended to prevent the patient from vomiting the
capsule.
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Note
This device is not meant to replace upper endoscopy.