Abiomed Impella 2.5, Instructions For Use Manual

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TABLE OF CONTENTS
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
®
CATHETER AND AUTOMATED IMPELLA
®
CONTROLLER
Overview ................................................................................................. 3.1
Impella
®
Catheter .................................................................................... 3.5
Automated Impella
®
Controller ................................................................ 3.11
Purge Cassette ......................................................................................... 3.12
Accessories .............................................................................................. 3.14
4 USING THE AUTOMATED IMPELLA
®
CONTROLLER
Overview ................................................................................................. 4.1
Automated Impella
® Controller Features .................................................. 4.2
Home Screen ............................................................................................ 4.6
Placement Screen ..................................................................................... 4.9
Purge Screen ............................................................................................ 4.10
Infusion History Screen ............................................................................ 4.11
Mobile Operation ..................................................................................... 4.12
5 USING THE AUTOMATED IMPELLA
®
CONTROLLER
WITH THE IMPELLA ® CATHETER
Pre-support Evaluation ............................................................................ 5.1
Startup ..................................................................................................... 5.2
Case Start ................................................................................................ 5.5
Impella
® 2.5 Catheter Insertion (Wired) ................................................... 5.12
Wireless Insertion of the Impella
®
2.5 Catheter ........................................ 5.16
Impella CP
®
Catheter Insertion ................................................................ 5.17
Axillary Insertion of the Impella
®
2.5, 5.0, or Impella CP
®
Catheter ......... 5.21
Alternate Insertion Technique for the Impella ® 5.0 Catheter..................... 5.25
Implanting and Starting the Impella ® LD Catheter .................................... 5.29
Positioning and Starting the Impella
®
2.5 and Impella CP
®
Catheters ...... 5.32
Positioning and Starting the Impella
®
5.0 Catheter .................................. 5.38
Positioning and Starting the Impella
®
LD Catheter ................................... 5.41
Purge Cassette Procedures ....................................................................... 5.44
Troubleshooting the Purge System ........................................................... 5.48
Patient Weaning ...................................................................................... 5.49
Removing the Impella
®
2.5, 5.0, or Impella CP
®
Catheter ........................ 5.50
Explanting the Impella
®
LD Catheter ........................................................ 5.52
6 CLINICAL EXPERIENCE
Cardiac Shock After Myocardial Infarction ............................................... 6.1
Summary of Primary Clinical Studies ........................................................ 6.1
Summary of Supplemental Clinical Information ....................................... 6.7
Cardiac Shock After Open Heart Surgery ................................................. 6.17
Summary of Primary Clinical Studies ........................................................ 6.17
Summary of Supplemental Clinical Information ....................................... 6.23
7 PATIENT MANAGEMENT TOPICS
Patient Management Overview ................................................................ 7.1
General Patient Care Considerations ....................................................... 7.1
Transport Within the Hospital .................................................................. 7.2
Right Heart Failure ................................................................................... 7.2
ECG Interference ...................................................................................... 7.3
Latex ........................................................................................................ 7.3
Use of Echocardiography for Positioning of the Impella
® Catheter............ 7.3
Understanding and Managing Impella
®
Catheter Position Alarms ............. 7.10
Impella Stopped ....................................................................................... 7.18
Suction .................................................................................................... 7.18
Hemolysis ................................................................................................ 7.19
Operating the Impella
® Catheter without Heparin in the Purge Solution .. 7.21
Placement Signal Lumen (for Impella
®
2.5 and Impella CP
®
) .................... 7.21
Pressure Sensor Drift and Sensor Failure (for Impella
®
5.0 and LD) ........... 7.23
Enabling Purge Flow Notifications ............................................................ 7.24
Disabling Audio for Placement Signal Lumen Blocked Alarm
(Impella
®
2.5 and Impella CP
®
) ................................................................ 7.24
Surgical Mode .......................................................................................... 7.25
Timed Data Recording .............................................................................. 7.25
Operating the Impella
® Catheter in Electromagnetic Fields ...................... 7.26
Transferring from the Automated Impella ® Controller to a New
Automated Impella
®
Controller ................................................................ 7.28
Emergency Shutdown Procedure .............................................................. 7.29
8 AUTOMATED IMPELLA
®
CONTROLLER ALARMS
Alarms Overview ...................................................................................... 8.1
Alarm Message Summary ......................................................................... 8.3
9 GENERAL SYSTEM INFORMATION
Terminology, Abbreviations, and Symbols ................................................ 9.1
Automated Impella
® Controller Mechanical Specifications ....................... 9.3
Automated Impella
®
Controller Electrical Specifications ........................... 9.3
Equipment Design .................................................................................... 9.4
Equipment Classifications ........................................................................ 9.5
Federal Communications Commission (FCC) Notice .................................. 9.5
Electromagnetic Compatibility ................................................................. 9.6
Transport Between Hospitals ................................................................... 9.7
Slave Monitor Connection ........................................................................ 9.11
Alarm Delay Information .......................................................................... 9.12
Patient Environment ................................................................................. 9.12
White Connector Cable ............................................................................ 9.13
Impella
®
Catheter Parameters .................................................................. 9.13
Impella
®
2.5 Catheter Dimensions ............................................................ 9.14
Impella CP
®
Catheter Dimensions ............................................................ 9.14
Impella ® 5.0 Catheter Dimensions............................................................ 9.15
Impella ® LD Catheter Dimensions ............................................................. 9.15
Cleaning .................................................................................................. 9.16
Storing the Automated Impella
®
Controller .............................................. 9.16
Returning an Impella
®
Catheter to Abiomed (United States) ..................... 9.16
APPENDICES
Appendix A: Impella
®
System Limited Service Warranty (United States) .. A.1
Appendix B: Abiomed-Approved Guidewires and Introducers
(Impella
®
2.5 and Impella CP
®
) ................................................................ B.1
Appendix C: Automated Impella
®
Controller Menu Structure .................. C.1