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

214 Essential Performance

Capsule Labeling

Each box has a label at the bottom as shown below. Each capsule is marked with the expiration date, lot

number, and a unique capsule ID code.

Essential Performance

PillCam 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.

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 DR2

and PillCam recorder DR3.

Warnings

• PillCam Capsule Endoscopy System and its components need special precautions regarding EMC and

need to be installed and put into service according to the EMC information provided in the

accompanying documents.

• Portable and mobile RF communications equipment can affect the PillCam video capsule and the

PillCam recorder.

• PillCam video capsules 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.

Lot Number

Expiration

Date

Capsule ID

Code