INTRODUCTION
Introduction ..................................................................................................... I
1 INDICATIONS, CONTRAINDICATIONS, AND POTENTIAL
ADVERSE EVENTS
Indications (United States) ............................................................................... 1.1
Contraindications (United States) ................................................................... 1.1
Potential Adverse Events (United States) ........................................................ 1.2
2 WARNINGS AND CAUTIONS
Warnings ........................................................................................................ 2.1
Cautions ...................................................................................................... 2.3
3 THE IMPELLA® RP CATHETER AND AUTOMATED IMPELLA®
CONTROLLER
Overview ............................................................................................................ 3.1
Impella® RP Catheter ..................................................................................... 3.3
Automated Impella® Controller ...................................................................... 3.5
Purge Cassette ................................................................................................. 3.6
Accessories ....................................................................................................... 3.8
4 USING THE AUTOMATED IMPELLA
®
CONTROLLER
Overview ..................................................................................................... 4.1
Automated Impella
®
Controller Features ......................................................... 4.1
Automated Impella
®
Controller Display ............................................................ 4.5
Placement Screen ............................................................................................ 4.8
Purge Screen ................................................................................................. 4.9
Infusion History ............................................................................................ 4.10
Mobile Operation ........................................................................................... 4 .11
5 USING THE AUTOMATED IMPELLA
®
CONTROLLER WITH THE
IMPELLA
®
RP CATHETER
Startup ............................................................................................................ 5.1
Case Start ...................................................................................................... 5.4
Inserting the Impella
®
RP Catheter ................................................................. 5.10
Positioning and Starting the Impella
®
RP Catheter ........................................... 5.12
Performance Levels ....................................................................................... 5.13
Suction .......................................................................................................... 5.13
Use of the Repositioning Sheath and the 23 Fr Peel-away Introducer ....... 5.14
Purge Cassette Procedures ............................................................................ 5.15
Troubleshooting the Purge System ............................................................... 5.18
Patient Weaning .......................................................................................... 5.20
Removing the Impella
®
RP Catheter ............................................................. 5.20
6 CLINICAL EXPERIENCE
Pivotal Clinical Study Design – RECOVER RIGHT ................................ 6.1
Accountability of Cohort …….......................................................................... 6.3
7 AUTOMATED IMPELLA
®
CONTROLLER ALARMS
Alarms Overview ........................................................................................ 7.1
Alarm Message Summary .......................................................................... 7.3
8 GENERAL SYSTEM INFORMATION
Terminology, Abbreviations, and Symbols ..................................................... 8.1
Automated Impella
®
Controller Mechanical Specifications .......................... 8.3
Automated Impella
®
Controller Electrical Specifications ............................... 8.3
Equipment Design ......................................................................................... 8.4
Equipment Classifications .......................................................................... 8.4
Federal Communications Commission (FCC) Notice .................................... 8.5
Electromagnetic Compatibility ...................................................................... 8.5
Transport Between Hospitals ………………………………………... 8.10
Transport Within the Hospital ………………………………………... 8.11
Slave Monitor Connection .......................................................................... 8.11
Alarm Delay Information ............................................................................. 8.12
Patient Environment .................................................................................... 8.12
White Connector Cable .............................................................................. 8.13
Impella
®
RP Catheter Parameters ............................................................... 8.13
Cleaning ..................................................................................................... 8.14
Storing the Automated Impella
®
Controller ................................................. 8.14
Returning an Impella
®
RP Catheter to Abiomed (United States) .................. 8.14
APPENDICES
Appendix A: Automated Impella
®
Controller Menu Structure ................... A .1
..
TABLE OF CONTENTS
