Given Imaging Limited CAPSH-3 User Manuals

User Manual (English)

User Manual

Table of Contents

User Manual
1
RAPID® v8.3
1
Table of Contents
3
Chapter 1
11
Using This Guide
11
- Conventions
  11
Chapter 2
13
Indications, Contraindications, Warnings, Cautions
13
- Indications for Use
  13
  - PillCam SB
    13
  - PillCam ESO
    13
  - PillCam UGI
    13
  - PillCam COLON
    14
- Contraindications
  14
  - PillCam SB
    14
  - PillCam ESO/PillCam UGI
    14
  - PillCam COLON
    14
- Adverse Events
  15
- Warnings
  15
- Cautions
  18
- Benefits and Risks—PillCam Capsule Endoscopy
  18
  - Benefits
    18
  - Risks
    19
- Essential Performance
  20
  - PillCam Video Capsules
    20
  - PillCam Recorder DR2 and PillCam Recorder DR3
    20
- Accuracy of the Device—SB
  20
- Accuracy of the Device—ESO
  22
- Accuracy of the Device—UGI
  23
- Accuracy of the Device—COLON 2
  27
  - Clinical Validation Study and Interpretation of Results
    27
    - Evaluation of Capsule Endoscopy with PillCam COLON 2 in Visualization of the Colon (MA-204)
      27
Chapter 3
39
Welcome to PillCam Capsule Endoscopy
39
- What is PillCam Capsule Endoscopy?
  39
- The PillCam Capsule Endoscopy Process
  39
- PillCam Capsule Endoscopy System Components
  39
  - PillCam Capsules
    39
  - Handling the PillCam Capsule
    41
  - PillCam Recorders
    41
  - PillCam Sensors
    42
  - RAPID for PillCam Software
    42
    - Home Screen
      42
Chapter 4
47
Preparing for PillCam Capsule Endoscopy
47
- Preparing the Patient
  47
- Preparing the Required Equipment
  48
  - Connecting the PillCam Recorder to RAPID for Check-in
    48
- Creating Patient Instructions for the Procedure
  50
  - Pre-ingestion Instruction Handouts
    50
  - Post-ingestion Instructions for Procedures Involving Colon Visualization
    51
- General Patient Guidelines During the Procedure
  52
- Performing Patient Check-in
  53
  - Updating Patient Details
    60
- Fitting Equipment on the Patient
  61
Chapter 5
73
Know Your PillCam Recorder
73
- Preparing the PillCam Recorder
  73
- Functions
  73
  - Initialization
    73
  - Pairing for DR3
    73
  - Real-Time Viewing
    73
  - Regimen Reminder
    74
  - Download
    74
- PillCam Recorder DR3
  74
  - General
    74
  - Turning On and Off
    75
  - Regimen Reminder
    76
  - Charging
    76
  - Controls
    77
    - Main Display
      77
    - LED Display
      78
    - Acknowledge (ACK) Button, Designated for Patient Use
      78
    - Navigation Buttons
      79
    - Button Pressing Indication
      79
    - Battery and Capsule Icons
      80
    - PillCam Recorder DR3 LEDs
      80
    - Screen Icons
      81
    - Check-in Screen Icons
      82
    - Error Messages
      83
- PillCam Recorder DR2
  84
  - General
    84
  - Turning On and Off
    84
  - Charging
    85
  - PillCam Recorder DR2 LEDs
    85
- Connecting a PillCam Recorder to a Personal Computer (PC)
  87
- Connecting a PillCam Recorder to the External Real-Time Viewer
  87
Chapter 6
89
Performing PillCam Capsule Endoscopy
89
- Setting Delay First Instruction in PillCam Recorder
  89
- PillCam Recorder—Capsule Pairing (DR3 only)
  90
  - Capsule Designation During Patient Check-in
    90
  - Capsule Designation Before Capsule Ingestion
    91
- Capsule Ingestion
  92
  - PillCam Recorder DR3
    93
  - PillCam Recorder DR2
    93
- After Capsule Ingestion
  94
  - PillCam ESO/UGI
    94
  - PillCam SB
    94
    - PillCam Recorder DR3
      94
    - PillCam Recorder DR2
      94
  - PillCam COLON (DR3 only)
    94
- Real-Time Viewing with PillCam Recorder DR3 Only— Internal Mode
  95
- Real-Time Viewing with PillCam Recorder DR2 Only— External Mode
  97
- Removing Equipment from the Patient
  97
Chapter 7
99
Creating RAPID Videos
99
- PillCam Recorder Download
  99
- Managing RAPID Video Data
  102
  - Copying Data from a PillCam Recorder
    103
  - Managing Data Files
    105
  - Batch Data Copy
    106
    - From PillCam Recorders
      106
    - From Video Data Files/USB Storage Devices
      106
  - Backing up Data
    106
Chapter 8
107
Reviewing and Interpreting RAPID Videos
107
- Loading a Study with the Study Manager
  107
  - Archives
    109
    - Adding an Archive
      109
    - Archive Options
      110
  - Studies
    110
    - Study Columns
      111
    - Study Options
      111
  - Understanding the Status Bar
    111
  - Action Buttons
    112
  - Search Function
    113
  - Managing Columns
    114
- Using the Study Manager
  117
  - Open
    117
  - Export
    117
  - Delete
    121
  - Offline Studies
    122
- Overview of the RAPID Interface
  124
  - Dialog Box Launchers
    124
  - Quick Access Toolbar
    125
  - File View
    126
  - View Screen
    127
  - View Ribbon
    128
    - Preview/Review Groups
      128
    - Preview Group buttons
      129
    - Review Group Buttons
      130
    - Viewing Layout Group
      130
    - Image Adjustment Group
      131
    - Zoom Group
      134
    - Show Group
      134
- Using RAPID to View a Video
  135
  - Reading a Capsule Endoscopy Video
    135
    - QuickView
      135
    - Complementary QuickView
      136
  - Viewing a Video
    136
  - Dynamic Player Control
    137
  - Dual Head View
    138
  - SBI View
    139
  - Time Bar/Color Bar
    139
    - Time Indication
      140
  - Creating and Annotating Thumbnails
    140
    - Thumbnail Status
      141
    - Thumbnail Comments
      142
    - Thumbnail Editor
      144
    - Marking Tools
      144
    - Mark Circle
      144
    - Mark Arrow
      145
    - Undo Mark
      145
    - Circumference Scale
      145
    - Polyp Size Estimation
      145
  - Using Localization and Landmarks
    147
    - Landmarks
      147
    - Suggested Flexure Landmarks for COLON Videos
      148
    - Suggested Landmarks for PillCam SB 3 Videos
      148
    - Localization
      148
    - PillCam Progress Indicator
      149
    - Colon Location Diagram
      150
    - Passage Times
      151
  - Comparing Thumbnails
    151
- RAPID Video Files
  153
- Working with Findings
  153
  - Saving Your Findings
    154
  - Opening a Findings File
    155
- Creating a PillCam Capsule Endoscopy Report
  156
  - Overview
    156
  - Report Ribbon
    157
    - Configure Buttons Group
      157
    - Report Buttons Group
      159
    - Markings Buttons Group
      162
    - Clinical Tools Buttons Group
      162
- RAPID Atlas
  163
  - Comparing Video Images to Atlas Images
    164
  - Atlas Image Export
    165
- Lewis Score
  165
- Generating a Report
  168
  - Image Data Buttons Group
    169
Appendix A1
173
Installing RAPID Software
173
- Setup Requirements
  173
- RAPID Installation
  173
- Main Endoscopy System Components
  174
- Connecting the Components
  174
- Connecting the PillCam Recorder Cradle
  175
- Starting RAPID for the First Time
  175
Appendix A2
179
Configuring RAPID Software
179
- Single or Multi-user Setting
  179
  - RAPID Workstation Configuration
    179
- RAPID Settings
  180
  - General Tab
    181
    - User Information Section
      181
    - Regional Settings Section
      182
    - Permissions Section
      183
  - Video Tab
    183
    - Video Creation Section
      184
    - Video Data Management Section
      184
    - Research Tools Section
      185
  - Report Tab
    186
  - Check-in Tab
    190
    - Configure Check-in Fields Section
      190
    - HIS Information Directory Section
      190
  - Other Tab
    191
    - Study Manager Section
      191
    - Regimen Settings Section
      191
    - Customer Support Section
      192
- Regimen Manager
  193
- Additional Settings
  202
  - Backup/Restore Offline Studies
    203
  - Importing Reports
    205
  - Freeing Space on Your Computer
    205
    - Deleting Videos
      205
    - Deleting Raw Data Files after Video Creation
      206
  - Backup System Logs
    206
  - CD/DVD Burning
    207
    - Roxio Drag-to-Disc 9
      207
    - DirectCD 5
      208
- Keyboard Shortcuts
  209
Appendix A3
211
PillCam Equipment Maintenance
211
- PillCam Recorder Maintenance
  211
  - Important Safety Instructions
    211
  - PillCam Recorder DR3
    212
  - PillCam Recorder DR2
    213
    - Charging
      213
    - Manual Discharge
      214
- PillCam Sensor Cleaning
  215
Appendix A4
217
Troubleshooting
217
- RAPID Video
  217
- Saving and Opening Videos
  217
- Printer
  218
- CD/DVD
  218
- Sensor Array
  218
- Sensor Belt
  219
- Capsule
  219
- Cradle
  219
- PillCam Recorder DR3
  219
- PillCam Recorder DR2
  220
- Error Messages
  221
- Low Signal
  222
Appendix A5
223
Technical Description
223
- System Labeling
  223
  - Capsule Labeling
    224
- Essential Performance
  224
  - PillCam Capsules
    224
  - PillCam Recorder DR2 and PillCam Recorder DR3
    224
- Warnings
  224
- Cautions
  226
- System Specifications
  227
  - PillCam SB 2 Capsule
    227
  - PillCam SB 3 Capsule
    228
  - PillCam UGI Capsule
    229
  - PillCam COLON 2 Capsule
    230
  - Sensor Array PillCam Recorder DR2
    231
  - Sensor Array PillCam Recorder DR3
    231
  - PillCam Recorder DR2/DR2C
    232
  - Cradle PillCam Recorder DR2
    232
  - PillCam Recorder DR3
    233
  - PillCam Recorder DR3 SDHC Memory Card
    234
  - Cradle PillCam Recorder DR3
    234
  - DC Power Supply
    234
  - RAPID for PillCam Software
    235
- Guidance and Manufacturer's Declarations
  235
  - PillCam Capsules
    235
  - PillCam Recorder DR2/DR2C
    239
  - PillCam Recorder DR3
    242
Index
247
- A
  247
- B
  247
- C
  247
- D
  247
- E
  247
- F
  247
- G
  247
- H
  247
- I
  247
- L
  248
- M
  248
- N
  248
- O
  248
- P
  248
- Q
  248
- R
  248
- S
  249
- T
  249
- U
  249
- V
  249
- X
  249
- Z
  249

Size:

3.98 MB
Pages:

250
Language:

English