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Impella CP
Instructions for use manual
Abiomed Impella CP Instructions For Use Manual
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Contents
Table of Contents
Troubleshooting
Bookmarks
Table of Contents
Table of Contents
Instructions for Use
Introduction
1 Indications, Contraindications, and Potential Adverse Events
Indications (United States)
Contraindications (United States)
Potential Adverse Events (United States)
2 Warnings and Cautions
Warnings
Cautions
3 The Impella ® Catheter and Automated Impella ® Controller
Overview
Figure 3.1 Impella ® Catheter in the Heart
Impella CP ® Catheter, and Accessories
Table 3.1 Impella ® Set-Up and Insertion Kit Components
Figure 3.3 Set-Up Configuration of the Automated Impella ® Controller, Impella
Impella ® Catheter
Impella
Figure 3.4 Impella ® Catheters
Table 3.3 Impella ® Catheter Components
And LD Differential Pressure Sensor (Impella ® 5.0 Shown)
Figure 3.6 Electrical Signal Generated by the Cardiac Cycle
Placement Signal
Automated Impella ® Controller
Figure 3.9 Automated Impella Controller - Front View
Purge Cassette
Figure 3.10 Purge Cassette
Table 3.4 Purge Cassette Components
Accessories
Figure 3.11 White Connector Cable
Figure 3.13 Impella CP ® Introducer Kit
Figure 3.14 Silicone Plugs (Impella ® 5.0/LD)
Figure 3.15 Impella ® Axillary Insertion Kit (Impella ® 2.5, 5.0, and Impella CP ® )
Figure 3.16 Placement Guidewire
Figure 3.17 Dextrose Solution
Figure 3.18 Automated Impella Controller Cart
4 Using the Automated Impella ® Controller
Overview
Automated Impella ® Controller Features
Figure 4.1 Automated Impella Controller Features - Front View
Figure 4.2 Automated Impella ® Controller Features - Side Views
Home Screen
Figure 4.3 Home Screen
Placement Screen
Figure 4.4 Placement Screen
Purge Screen
Figure 4.5 Purge Screen
Infusion History Screen
Mobile Operation
Figure 4.6 Infusion History Screen
5 Using the Automated Impella ® Controller with the Impella ® Catheter
Figure 3.5 Impella
Pre-Support Evaluation
Startup
Figure 5.1 Automated Impella Controller Power Switch
Figure 5.2 Automated Impella ® Controller Startup Screen
Case Start
Figure 5.3 Initial Case Start Screen
Figure 5.4 Inserting Purge Cassette into Automated Impella ® Controller
Figure 5.5 Inserting the Catheter Plug into the Connector Cable
Figure 5.6 Snapping Plastic Clip to Connector Cable (Impella CP Shown)
Figure 5.7 Priming the Impella Purge Lumen
Figure 5.9 Priming the Placement Signal Lumen
Figure 5.10 Squeezing the White Flush Valve to Prime the Placement
Figure 5.11 Entering Purge Fluid Information
Figure 5.12 Connecting the Purge Tubing to the Connector Cable
Figure 5.13 Set-Up Configuration of the Impella ® System
Impella ® 2.5 Catheter Insertion (Wired)
Figure 5.14 Inserting the Peel-Away Introducer
Figure 5.15 Inserting the Diagnostic Catheter
Figure 5.16 Loading the Catheter on the Guidewire Using the Easyguide Lumen
Figure 5.17 Loading the Catheter on the Guidewire Without the Easyguide Lumen and Aligning the Placement Guidewire
Figure 5.19 Aortic Waveform on Placement Signal Screen
Wireless Insertion of the Impella ® 2.5 Catheter
Impella CP ® Catheter Insertion
Figure 5.20 Inserting the Peel-Away Introducer
Figure 5.21 Inserting the Diagnostic Catheter
Figure 5.22 Loading the Catheter on the Guidewire Using the Easyguide Lumen
Figure 5.23 Loading the Catheter on the Guidewire Without the Easyguide Lumen and Aligning the Placement Guidewire
Figure 5.24 Inserting the Impella ® Catheter
Figure 5.25 Aortic Waveform on Placement Screen
Axillary Insertion of the Impella ® 2.5, 5.0, or Impella CP ® Catheter
Figure 5.26 Introducer, Graft Lock, and Hemashield Platinum Graft (Graft Not Supplied)
Figure 5.27 Correct Positioning if Second Graft Lock Required
Figure 5.28 Closing the Graft Lock
Figure 5.29 Releasing the Graft Lock
Alternate Insertion Technique for the Impella ® 5.0 Catheter
Figure 5.31 Guidewire Placement
Figure 5.32 Femoral Artery Insertion of the Impella ® 5.0 Catheter Using
Implanting and Starting the Impella ® LD Catheter
Figure 5.33 Impella ® LD Catheter with Silicone Plugs
Figure 5.34 Waveform as Catheter Is Advanced into the Aorta
Figure 5.35 Pulsatile Waveform on Placement Signal Screen
Positioning and Starting the Impella ® 2.5 and Impella CP ® Catheters
Figure 5.36 Starting the Impella
Figure 5.38 Ventricular Waveform on Placement Signal Screen
Figure 5.39 Transfer to P-Level Mode
Figure 5.40 Adjusting P-Level
Figure 5.41 Removing the Peel-Away Introducer (14 Fr Introducer Shown)
Figure 5.42 Standard Configuration for Impella ® System after Transfer
From the Set-Up Configuration
Positioning and Starting the Impella ® 5.0 Catheter
Positioning and Starting the Impella ® LD Catheter
Figure 5.43 Waveform as Catheter Is Advanced into the Aorta
Figure 5.44 Pulsatile Waveform on Placement Screen
Figure 5.45 Selecting P-Level
Figure 5.46 Confirming Placement on the Placement Signal Screen
Device
Figure 5.47 Selecting P-Level
Figure 5.48 Confirming Placement on the Placement Signal Screen
Figure 5.49 Impella ® LD Catheter after Implantation
Purge Cassette Procedures
Figure 5.50 Disconnecting the y Connector from the Purge Cassette
Tubing
Troubleshooting the Purge System
Patient Weaning
Removing the Impella ® 2.5, 5.0, or Impella CP ® Catheter
Figure 5.51 Removing the Stylet
Figure 5.52 Inserting the Guidewire with the Cheater
Figure 5.53 Loosening the Tuohy-Borst Valve
Explanting the Impella ® LD Catheter
6 Clinical Experience
Cardiac Shock after Myocardial Infarction
Summary of Primary Clinical Studies
Table 6.1 Baseline Demographics and Characteristics
Figure 6.1 Kaplan-Meier Survival Curves Survival (to 30 Days) for the ISAR-SHOCK Trial
Cohort
Figure 6.2 Lactate Levels Seen Post-Implant During the Trial
Figure 6.3 Increase in Cardiac Index from Baseline, Impella Vs. IABP
Figure 6.4 Change in Inotropic Dosage at 24 Hours, Impella Vs. IABP
Summary of Supplemental Clinical Information
Figure 6.5 Time Intervals for Impella Implants Data Collection by Type of
Figure 6.6 Kaplan-Meier Curve Estimates for 30 Day Survival - All Patient
Figure 6.8 Outcomes between Impella Registry Subgroups: Patients Likely to be Eligible for Rcts Vs. Patients Likely to be Excluded from Rcts ("Salvage" Patients)
Figure 6.9 30-Day Outcomes (by Device) between Impella Registry Subgroups: Patients Likely to be Eligible for Rcts Vs. Patients Likely to be Excluded from Rcts ("Salvage" Patients)
Figure 6.11 Kaplan-Meier Curve Estimates for 30-Day Survival
Figure 6.14 Decrease in Inotropes and Pressors (Post-Device Placement) for RECOVER I Patients
Cardiac Shock after Open Heart Surgery
Summary of Primary Clinical Studies
Figure 6.15 RECOVER I Enrollment
Figure 6.16 Kaplan-Meier Survival Curve for Freedom from Death (to 1 Year)
Summary of Supplemental Clinical Information
Figure
Figure
Figure 6.27 Flow Diagram of the Distribution of the AB5000 LVAD PCCS Patient Cohort
Figure 6.30 Decrease in Inotropes and Pressors (Post-Device Placement) for RECOVER I Patients
7 Patient Management Topics
General Patient Care Considerations
Patient Management Overview
Transport Within the Hospital
Right Heart Failure
ECG Interference
Latex
Use of Echocardiography for Positioning of the Impella ® Catheter
Background
Correct Impella ® Catheter Position
Impella ® Catheter too Far into the Left Ventricle
Impella ® Catheter Inlet in the Aorta
Impella ® Catheter in Papillary Muscle
Color Doppler Echocardiography
Understanding and Managing Impella ® Catheter Position Alarms
Post-Insertion Positioning (PIP) Checklist
Correct Position
Impella CP Catheter Fully in Ventricle ....................................7.12
Outlet Areas in Ventricle and Open Pressure Area in Aorta
And Impella
Impella
Low Native Heart Pulsatility (Impella ® 5.0 and
Impella Stopped
Suction
Suction with the Impella ® 2.5 or Impella CP Catheter
Hemolysis
Table 7.1 Guide for Managing Hemolysis in Various Circumstances
Operating the Impella ® Catheter Without Heparin in the Purge Solution
Placement Signal Lumen (for Impella ® 2.5 and Impella CP ® )
Placement Signal Lumen (for Impella ® 2.5 and Impella
Flush Solution Change out Procedure
Figure 7.13 Displacing Air During Flush Solution Change out Procedure
Pressure Sensor Drift and Sensor Failure (for Impella ® 5.0 and LD)
Pressure Sensor Drift and Sensor Failure (for Impella ® 5.0 and
Manually Zeroing the Differential Pressure Sensor
Sensor Failure and Effects on Flow Calculations
Sensor Failure and Effects on Position Control
Disabling Audio for Placement Signal Lumen Blocked Alarm (Impella ® 2.5 and Impella
Enabling Purge Flow Notifications
Enabling Purge Flow Notifications
Disabling Audio for Placement Signal Lumen Blocked Alarm (Impella ® 2.5 and Impella CP ® )
Suction Detection During Sensor Drift or Sensor Failure
Surgical Mode
Timed Data Recording
Operating the Impella ® Catheter in Electromagnetic Fields
Electroanatomic Mapping (EAM) Systems
Magnetic Navigation Systems (MNS)
Transferring from the Automated Impella Controller to a New Automated Impella Controller
Transfer Steps
Patient Management Checklist Following Transfer of Support
Emergency Shutdown Procedure
8 Automated Impella Controller® Alarms
8 Automated Impella ® Controller Alarms
Alarms Overview
Alarm Levels
Alarm Display
Mute Alarm Function
Alarm History Screen
Figure 8.1 Alarm Window
Alarm Message Summary
9 General System Information
Terminology, Abbreviations, and Symbols
Terminology and Abbreviations
Symbols
Equipment Design
Equipment Classifications
Equipment Classifications
Federal Communications Commission (FCC) Notice
Electromagnetic Compatibility
Transport between Hospitals
Guidelines for Patient Transport
FAA Advisory
Important Transport Considerations
Vga Monitor Connection
Alarm Delay Information
Patient Environment
White Connector Cable
Impella ® Catheter Parameters
Impella CP ® Catheter Dimensions
Impella ® 2.5 Catheter Dimensions
Impella ® 5.0 Catheter Dimensions
Impella ® 5.0 Catheter Dimensions
Impella ® LD Catheter Dimensions
Cleaning
Storing the Automated Impella ® Controller
Appendices
Appendix A: Impellasystem Limited Service Warranty (United States)
Appendix B: Abiomed-Approved Guidewires and Introducers (Impella ® 2.5 and Impella CP ® )
Appendix C: Automated Impella ® Controller Menu Structure
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Instructions for Use
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Ventricular
Impella
Support
Systems
for Use During Cardiogenic Shock
Impella
2.5, 5.0, LD and Impella CP
®
®
INSTRUCTIONS FOR USE
& CLINICAL REFERENCE MANUAL
(United States only)
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Table of Contents
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7 Patient Management Topics
140
8 Automated Impella Controller® Alarms
172
9 General System Information
182
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