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

Technical Description

System Specifications 223

PillCam Recorder DR3

Properties

Physical Software Proprietary firmware

Recording capacity Up to 15 hours @ LCD OFF

Weight 500 g, including battery pack

Operational Power 3.5–4.2 V DC, 0.15–0.5 A

Battery type Internal, Li-Ion, 3.8 V typical,

8800 mAH

Operating temp.

0–40

°C

Storage temp.

0–55°C

Storage and Operating

humidity

Up to 85%

Storage and Operating

pressure

790–520 mmHg

Receiver (Rx) Operating frequency 434.1 MHz

Bandwidth of the

receiving section in this

band

10 MHz

Transmitter Operating frequency 13.6 MHz

Frequency band ISM

Modulation type Linear Chirp

Type of modulated

signal

Digital data

Effective radiated

power

-27.4 dBm