User's Manual

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Table Of Contents

User Manual
RAPID® v8.3
Table of Contents
Chapter 1
Using This Guide
- Conventions
Chapter 2
Indications, Contraindications, Warnings, Cautions
- Indications for Use
- Contraindications
- Adverse Events
- Warnings
- Cautions
- Benefits and Risks—PillCam Capsule Endoscopy
  - Benefits
  - Risks
- Essential Performance
  - PillCam Video Capsules
  - PillCam Recorder DR2 and PillCam Recorder DR3
- Accuracy of the Device—SB
- Accuracy of the Device—ESO
- Accuracy of the Device—UGI
- Accuracy of the Device—COLON 2
  - Clinical Validation Study and Interpretation of Results
    - Evaluation of Capsule Endoscopy with PillCam COLON 2 in Visualization of the Colon (MA-204)
Chapter 3
Welcome to PillCam Capsule Endoscopy
- What is PillCam Capsule Endoscopy?
- The PillCam Capsule Endoscopy Process
- PillCam Capsule Endoscopy System Components
Chapter 4
Preparing for PillCam Capsule Endoscopy
- Preparing the Patient
- Preparing the Required Equipment
  - Connecting the PillCam Recorder to RAPID for Check-in
- Creating Patient Instructions for the Procedure
  - Pre-ingestion Instruction Handouts
  - Post-ingestion Instructions for Procedures Involving Colon Visualization
- General Patient Guidelines During the Procedure
- Performing Patient Check-in
  - Updating Patient Details
- Fitting Equipment on the Patient
Chapter 5
Know Your PillCam Recorder
- Preparing the PillCam Recorder
- Functions
- PillCam Recorder DR3
- PillCam Recorder DR2
- Connecting a PillCam Recorder to a Personal Computer (PC)
- Connecting a PillCam Recorder to the External Real-Time Viewer
Chapter 6
Performing PillCam Capsule Endoscopy
- 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
- 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
Chapter 7
Creating RAPID Videos
- PillCam Recorder Download
- Managing RAPID Video Data
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
  - Saving Your Findings
  - Opening a Findings File
- Creating a PillCam Capsule Endoscopy Report
  - Overview
  - Report Ribbon
- RAPID Atlas
  - Comparing Video Images to Atlas Images
  - Atlas Image Export
- Lewis Score
- Generating a Report
  - Image Data Buttons Group
Appendix A1
Installing RAPID Software
- Setup Requirements
- RAPID Installation
- Main Endoscopy System Components
- Connecting the Components
- Connecting the PillCam Recorder Cradle
- Starting RAPID for the First Time
Appendix A2
Configuring RAPID Software
- Single or Multi-user Setting
  - RAPID Workstation Configuration
- RAPID Settings
- Regimen Manager
- Additional Settings
- Keyboard Shortcuts
Appendix A3
PillCam Equipment Maintenance
- PillCam Recorder Maintenance
- PillCam Sensor Cleaning
Appendix A4
Troubleshooting
- RAPID Video
- Saving and Opening Videos
- Printer
- CD/DVD
- Sensor Array
- Sensor Belt
- Capsule
- Cradle
- PillCam Recorder DR3
- PillCam Recorder DR2
- Error Messages
- Low Signal
Appendix A5
Technical Description
- System Labeling
  - Capsule Labeling
- Essential Performance
  - PillCam Capsules
  - PillCam Recorder DR2 and PillCam Recorder DR3
- Warnings
- Cautions
- System Specifications
- Guidance and Manufacturer's Declarations
Index
- A
- B
- C
- D
- E
- F
- G
- H
- I
- L
- M
- N
- O
- P
- Q
- R
- S
- T
- U
- V
- X
- Z

PillCam Capsule Endoscopy

iv Table of Contents

Chapter 8

Reviewing and Interpreting RAPID Videos .............................................. 97

Loading a Study with the Study Manager ........................................................................... 97

Archives............................................................................................................................ 99

Adding an Archive ................................................................................................................... 99

Archive Options..................................................................................................................... 100

Studies............................................................................................................................ 100

Study Columns...................................................................................................................... 101

Study Options........................................................................................................................ 101

Understanding the Status Bar ........................................................................................ 101

Action Buttons ................................................................................................................ 102

Search Function ............................................................................................................. 103

Managing Columns......................................................................................................... 104

Using the Study Manager ................................................................................................... 107

Open ............................................................................................................................... 107

Export ............................................................................................................................. 107

Burning a Study to a CD/DVD............................................................................................... 108

Saving a Study to Another Archive ....................................................................................... 110

Saving a Study as a Zip File ................................................................................................. 111

Delete ............................................................................................................................. 111

Offline Studies ................................................................................................................ 112

Overview of the RAPID Interface........................................................................................ 114

Dialog Box Launchers .................................................................................................... 114

Quick Access Toolbar..................................................................................................... 115

File View ......................................................................................................................... 116

View Screen ................................................................................................................... 117

View Ribbon ................................................................................................................... 118

Preview/Review Groups ........................................................................................................ 118

Preview Group buttons ......................................................................................................... 119

Review Group Buttons ......................................................................................................... 120

Viewing Layout Group........................................................................................................... 120

Image Adjustment Group ...................................................................................................... 121

Zoom Group .......................................................................................................................... 124

Show Group .......................................................................................................................... 124

Using RAPID to View a Video ............................................................................................. 125

Reading a Capsule Endoscopy Video ............................................................................ 125

QuickView ............................................................................................................................. 125

Complementary QuickView................................................................................................... 126

Viewing a Video.............................................................................................................. 126

Dynamic Player Control.................................................................................................. 127

Dual Head View.............................................................................................................. 128

SBI View ........................................................................................................................ 129

Time Bar/Color Bar......................................................................................................... 129

Time Indication...................................................................................................................... 130

Creating and Annotating Thumbnails ............................................................................. 130

Thumbnail Status .................................................................................................................. 131

Thumbnail Comments ........................................................................................................... 132

Thumbnail Editor ................................................................................................................... 134

Marking Tools........................................................................................................................ 134

Mark Circle ............................................................................................................................ 134

Mark Arrow ............................................................................................................................ 135

Undo Mark ............................................................................................................................ 135