User's Manual

Table of Contents i
Table of Contents
Chapter 1
Using This Guide .......................................................................................... 1
Conventions ............................................................................................................................. 1
Chapter 2
Indications, Contraindications, Warnings, Cautions ................................ 3
Indications for Use................................................................................................................... 3
PillCam SB.......................................................................................................................... 3
PillCam ESO ....................................................................................................................... 3
PillCam UGI ........................................................................................................................ 3
PillCam COLON.................................................................................................................. 4
Contraindications .................................................................................................................... 4
PillCam SB.......................................................................................................................... 4
PillCam ESO/PillCam UGI .................................................................................................. 4
PillCam COLON.................................................................................................................. 4
Adverse Events........................................................................................................................ 5
Warnings................................................................................................................................... 5
Cautions.................................................................................................................................... 8
Benefits and Risks—PillCam Capsule Endoscopy............................................................... 8
Benefits ............................................................................................................................... 8
Risks ................................................................................................................................... 9
Essential Performance .......................................................................................................... 10
PillCam Video Capsules ................................................................................................... 10
PillCam Recorder DR2 and PillCam Recorder DR3 ......................................................... 10
Accuracy of the Device—SB................................................................................................. 10
Accuracy of the Device—ESO .............................................................................................. 12
Accuracy of the Device—UGI ............................................................................................... 13
Accuracy of the Device—COLON 2...................................................................................... 17
Clinical Validation Study and Interpretation of Results ..................................................... 17
Evaluation of Capsule Endoscopy with PillCam COLON 2 in Visualization of the Colon (MA-204) 17
Chapter 3
Welcome to PillCam Capsule Endoscopy ................................................ 29
What is PillCam Capsule Endoscopy? ................................................................................ 29
The PillCam Capsule Endoscopy Process .......................................................................... 29
PillCam Capsule Endoscopy System Components............................................................ 29
PillCam Capsules.............................................................................................................. 29
Handling the PillCam Capsule .......................................................................................... 31
PillCam Recorders ............................................................................................................ 31
PillCam Sensors ............................................................................................................... 32
RAPID for PillCam Software ............................................................................................. 32
Home Screen .......................................................................................................................... 32