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

Table of Contents vii

Appendix A4

Troubleshooting ....................................................................................... 207

RAPID Video ......................................................................................................................... 207

Saving and Opening Videos ............................................................................................... 207

Printer ................................................................................................................................... 208

CD/DVD ................................................................................................................................. 208

Sensor Array ........................................................................................................................ 208

Sensor Belt ........................................................................................................................... 209

Capsule ................................................................................................................................. 209

Cradle.................................................................................................................................... 209

PillCam Recorder DR3......................................................................................................... 209

PillCam Recorder DR2......................................................................................................... 210

Error Messages.................................................................................................................... 211

Low Signal ............................................................................................................................ 212

Appendix A5

Technical Description .............................................................................. 213

System Labeling .................................................................................................................. 213

Capsule Labeling ............................................................................................................ 214

Essential Performance ........................................................................................................ 214

PillCam Capsules............................................................................................................ 214

PillCam Recorder DR2 and PillCam Recorder DR3 ....................................................... 214

Warnings............................................................................................................................... 214

Cautions................................................................................................................................ 216

System Specifications......................................................................................................... 217

PillCam SB 2 Capsule..................................................................................................... 217

PillCam SB 3 Capsule..................................................................................................... 218

PillCam UGI Capsule ...................................................................................................... 219

PillCam COLON 2 Capsule............................................................................................. 220

Sensor Array PillCam Recorder DR2.............................................................................. 221

Sensor Array PillCam Recorder DR3.............................................................................. 221

PillCam Recorder DR2/DR2C ........................................................................................ 222

Cradle PillCam Recorder DR2 ........................................................................................ 222

PillCam Recorder DR3 ................................................................................................... 223

PillCam Recorder DR3 SDHC Memory Card.................................................................. 224

Cradle PillCam Recorder DR3 ........................................................................................ 224

DC Power Supply............................................................................................................ 224

RAPID for PillCam Software ........................................................................................... 225

Guidance and Manufacturer's Declarations...................................................................... 225

PillCam Capsules............................................................................................................ 225

PillCam Recorder DR2/DR2C ........................................................................................ 229

PillCam Recorder DR3 ................................................................................................... 232

Index .......................................................................................................... 237