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Table of Contents
PATENTS AND TRADEMARKS ................................................................................................................... 8
PATENTS ....................................................................................................................................................... 8
TRADEMARKS ................................................................................................................................................. 8
WARNINGS AND PRECAUTIONS ............................................................................................................... 9
READ AND REVIEW MANUAL BEFORE OPERATION ................................................................................................. 9
FOR USE ONLY BY TRAINED MEDICAL PERSONNEL ................................................................................................. 9
SYSTEM USE CAUTIONS AND WARNINGS ............................................................................................................. 9
PIM USE CAUTIONS AND WARNINGS ............................................................................................................... 12
CATHETER AND WIRE USE CAUTIONS AND WARNINGS ......................................................................................... 13
CHAPTER 1: OVERVIEW .......................................................................................................................... 14
INTRODUCTION ............................................................................................................................................. 14
INDICATIONS FOR USE .................................................................................................................................... 17
CLINICAL APPLICATIONS .................................................................................................................................. 18
CONTRAINDICATIONS ..................................................................................................................................... 18
POSSIBLE ADVERSE REACTIONS ........................................................................................................................ 18
CHAPTER 2: SYSTEM DESCRIPTION ......................................................................................................... 20
SYSTEM OVERVIEW ....................................................................................................................................... 20
MONITOR .................................................................................................................................................... 21
CONTROL CONSOLE ....................................................................................................................................... 22
JOYSTICK CONTROLLER OPTION ........................................................................................................................ 25
WORKSTATION (CENTRAL PROCESSING UNIT)..................................................................................................... 27
PRINTER ...................................................................................................................................................... 27
CONNECTOR PANEL ....................................................................................................................................... 27
PATIENT INTERFACE MODULE .......................................................................................................................... 30
CATHETERS .................................................................................................................................................. 30
AVAILABLE OPTIONS ...................................................................................................................................... 31
CHAPTER 3: SYSTEM SETUP .................................................................................................................... 32
OVERVIEW ................................................................................................................................................... 32
INSTALLATION............................................................................................................................................... 32
TURNING SYSTEM ON .................................................................................................................................... 33
IVUS SOFTWARE SETTINGS ............................................................................................................................. 33
CHAPTER 4: PREPARING FOR A CASE ...................................................................................................... 44
OVERVIEW ................................................................................................................................................... 44
ENSURE SYSTEM POWER IS ON ........................................................................................................................ 44
CONNECT THE PIM ....................................................................................................................................... 45
ENTER PATIENT INFORMATION ........................................................................................................................ 46
CHAPTER 5: ACQUIRING IVUS IMAGES ................................................................................................... 48
OVERVIEW ................................................................................................................................................... 48
INSERT THE CATHETER .................................................................................................................................... 48
ADJUST THE IMAGE (IF DESIRED) ...................................................................................................................... 49
CHAPTER 6: RECORDING IVUS IMAGES .................................................................................................. 54
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