Abiomed Impella 5.5 Manuals

Manuals and User Guides for Abiomed Impella 5.5. We have 2 Abiomed Impella 5.5 manuals available for free PDF download: Instructions For Use Manual, User Manual

Abiomed Impella 5.5 Instructions For Use Manual (243 pages)

with SmartAssist. Impella 5.5

Brand: Abiomed | Category: Medical Equipment | Size: 22 MB

Table of Contents
4
Introduction
9
Indications, Contraindications, and Potential Adverse Events
10
Indications (United States)
11
Contraindications (United States)
11
Potential Adverse Events (United States)
11
Warnings and Cautions
12
Warnings
13
Cautions
16
The Impella Catheter and Automated Impella Controller
18
Overview
19
Figure 3.1 Impella Catheter in the Heart
19
Figure 3.2 Set-Up Configuration of the Automated Impella Controller, Impella 5.5 Catheter
20
Impella Catheter
21
Figure 3.3 Impella 5.5 with Smartassist Catheter
21
Automated Impella Controller
23
Figure 3.4 Automated Impella Controller - Front View
23
Purge Cassette
24
Figure 3.5 Purge Cassette
24
Accessories
26
Figure 3.6 Impella Axillary Insertion Kit
26
Figure 3.7 Placement Guidewire
26
Figure 3.8 Silicone Plugs
26
Figure 3.9 Incision Template
26
Figure 3.10 3Pt Fixation Accessory
27
Figure 3.11 Dextrose Solution
27
Figure 3.12 Automated Impella Controller Cart
27
Using the Automated Impella Controller
28
Overview
29
Automated Impella Controller Features
29
Figure 4.1 Automated Impella Controller Features - Front View
29
Figure 4.2 Automated Impella Controller Features - Side Views
31
Home Screen
33
Figure 4.3 Home Screen with Pump Metrics Enabled
33
Placement Screen
37
Figure 4.4 Placement Screen
37
Purge Screen
39
Figure 4.5 Purge Screen
39
Purge Infusion History Screen
40
LVEDP/CO Trend Screen
41
Figure 4.7 LVEDP/CO Trend Screen
41
Mobile Operation
42
Using the Automated Impella Controller with the Impella Catheter
44
Pre-Support Evaluation
45
Startup
46
Turning on the Automated Impella Controller
47
Figure 5.1 Automated Impella Controller Power Switch
47
Figure 5.2 Automated Impella Controller Startup Screen
48
Case Start
49
Figure 5.3 Initial Case Start Screen
50
Figure 5.4 Inserting Purge Cassette into Automated Impella Controller
51
Figure 5.5 Connecting Impella Catheter
52
Figure 5.6 Connecting Luer and Priming Impella Catheter
52
Figure 5.7 Connecting the Luer to the Impella Catheter
53
Figure 5.8 Entering Purge Fluid Information
53
Figure 5.9 Changing the Purge Fluid Information
54
Axillary Insertion of the Impella 5.5 Catheter
55
Figure 5.10 Introducer, Graft Lock, and Hemashield Platinum Graft (Graft Not Supplied)
56
Figure 5.11 Correct Positioning if Second Graft Lock Required
57
Figure 5.12 Closing the Graft Lock
57
Figure 5.13 Releasing the Graft Lock
58
Alternate Insertion Technique Using a Sidearm Graft & Silicone Plugs
59
Figure 5.14 Removing the Peel-Away Introducer
59
Figure 5.15 Axillary Artery Insertion of the Impella 5.5 Catheter Using a Sidearm Graft
60
Direct Aortic Insertion with Axillary Introducer
62
Figure 5.16 Impella 5.5 Catheter with Silicone Plugs
65
Positioning & Starting Impella 5.5 with Smartassist Catheter
66
Use of the Repositioning Unit
67
P-Level
68
Figure 5.18 Adjusting P-Level
68
Adjusting the LV Placement Signal
69
Figure 5.19 Adjust LV White Notification
69
Figure 5.20 Pump Metrics IFU Post-Calibration in LV Adjust Tool
70
Entering Cardiac Output
71
Figure 5.22 Pump Metrics IFU Enter Cardiac Output Tool
71
Figure 5.23 Cardiac Output Confirmation
72
Figure 5.24 Pump Metrics IFU Yellow CPO
73
Purge Cassette Procedures
74
Figure 5.25 Disconnecting the Extension Tubing from the Purge
74
Troubleshooting the Purge System
76
Figure 5.26 Air Detected Alert
76
Patient Weaning
77
Clinical Experience
80
Clinical Experience Overview for HRPCI
83
PROTECT I Clinical Study
83
PROTECT II Pivotal Clinical Study Design
84
Figure 6.1 PROTECT II Study Schematic
87
Accountability of PROTECT II Cohort
88
Figure 6.2 Study Flow Schematic
88
Limitations of Interpretation of Study Results
89
Study Population Demographics and Baseline Characteristics
89
Procedural Characteristics
92
Safety and Effectiveness Results
95
Figure 6.3 Kaplan-Meier Curves for Major Adverse Events (Intent-To-Treat Population)
97
Figure 6.4 Kaplan-Meier Curves for Major Adverse Events (Per-Protocol Population)
97
Secondary Safety Results
102
Secondary Effectiveness Results
104
Summary of Supplemental Clinical Information
105
Figure 6.5 Additional Analysis of the Composite MAE and MACCE Rates in the Per-Protocol Population Using a Meaningful, Contemporary Definition for Peri-Procedural MI (8X ULN)
106
Figure 6.6 Additional Analysis of the Composite MAE and MACCE Rates in the Intent-To-Treat Population Using a Meaningful
106
Figure 6.7 In-Hospital Mortality for "All Uspella HRPCI Patients," "All Uspella HRPCI Patients Who Met PROTECT II Criteria" and PROTECT II Patients for both IABP and Impella 2.5 Arm
107
Figure 6.8 Time Intervals for Impella Implants (Patient Selection) by Type of Device
108
Figure 6.9 Kaplan-Meier Curve for Freedom from Death to 30-Days in HRPCI Patients Supported with Impella 2.5 or Impella CP
111
Table 6.16 Clinical Evidence to Support the Impella
112
Figure 6.10 Time Intervals for Impella Support (Patient Selection) by Type of Device
113
Table 6.17 Patient Demographics and Baseline Characteristics
115
Table 6.19 In-Hospital Site-Reported Adverse Events
119
Figure 6.11 Kaplan-Meier Curve for Freedom from Death to 30-Days in
120
Figure 6.12 Kaplan-Meier Curve for Freedom from MACCE to 30-Days in
121
Conclusion
122
Clinical Experience Overview for Cardiogenic Shock after Acute Myocardial Infarction or Open Heart Surgery
123
Cardiac Shock after Acute Myocardial Infarction - Summary of Primary Clinical Studies
123
Table 6.20 Baseline Demographics and Characteristics
125
Figure 6.13 Kaplan-Meier Survival Curves Survival (to 30-Days) for the ISAR-SHOCK Trial
126
Table 6.21 Baseline Hemodynamics
126
Figure 6.14 Lactate Levels Seen Post-Implant During the Trial
127
Table 6.22 Adverse Events Monitoring
127
Figure 6.15 Increase in Cardiac Index from Baseline, Impella Vs. IABP
128
Figure 6.16 Change in Inotropic Dosage at 24-Hours, Impella Vs. IABP, in Patients Treated for Cardiogenic Shock after an AMI (ISAR-SHOCK)
128
Summary of Supplemental Clinical Information
129
Figure 6.17 Time Intervals for Impella Implants Data Collection by Type of Device
130
Figure 6.18 Kaplan-Meier Curve Estimates for 30-Day Survival - All Patient Cohort
131
Figure 6.19 Kaplan-Meier Curve Estimates, 30-Day Survival (by Device) - All Patient Cohort
131
Figure 6.20 Outcomes between Impella Registry Subgroups: Patients
132
Figure 6.21 30-Day Outcomes (by Device) between Impella Registry
133
Figure 6.22 Survival to Discharge Outcomes (by Device) between Impella Registry Subgroups: Patients Likely to be Eligible for Rcts Vs. Patients Likely to be Excluded from Rcts ("Salvage" Patients)
133
Figure 6.23 Kaplan-Meier Curve Estimates for 30-Day Survival
134
Figure 6.24 Survival to Discharge in AMICS Cohort
135
Table 6.23 Site-Reported Adverse Events (to Discharge) by Classification
136
Figure 6.25 Improvement in Patient Hemodynamics (from Baseline to 48Hrs Post Device Implant) for RECOVER I Patients
138
Figure 6.26 Decrease in Inotropes and Pressors (Post-Device Placement) for RECOVER I Patients
138
Cardiac Shock after Open Heart Surgery - Summary of Primary Clinical Studies
140
Figure 6.27 RECOVER I Enrollment
142
Table 6.24 Baseline Patient Characteristics
142
Table 6.25 Baseline Patient Hemodynamics
143
Figure 6.28 Kaplan-Meier Survival Curve for Freedom from Death (to 1 Year)
144
Summary of Supplemental Clinical Information
146
Figure 6.29 Time Intervals for Impella Implants Data Collection by Type of Device
146
Figure 6.30 Kaplan-Meier Curve Estimates for 30-Day Survival - All Patients Cohort
147
Figure 6.31 Kaplan-Meier Curve Estimates for 30-Day Survival - for Different Devices
147
Figure 6.32 Groups Used for each Classification Analysis
148
Figure 6.33 Kaplan-Meier Curve for 30-Day Survival Using Classification a (All Patients)
148
Figure 6.34 Kaplan-Meier Curve for 30-Day Survival Using Classification a (Patients with Impella 5.0/Impella LD)
149
Table 6.26 Site-Reported Adverse Events (to Discharge) by Classification
153
Impella PCCS Post-Approval Study (PAS)
156
Clinical Experience Overview for Cardiogenic Shock in the Setting of Cardiomyopathy, Myocarditis, and Peripartum Cardiomyopathy
160
Table 6.27 Demographics and Baseline Characteristics
161
Table 6.28 Baseline Hemodynamics
162
Table 6.29 Impella Support Characteristics
162
Table 6.31 Site-Reported Adverse Events (to Discharge)
166
Table 6.32 Causes of In-Hospital Death
167
Impella AMI CS Post-Approval Study (RECOVER III)
173
Table 6.36 Primary Endpoint - Survival at 30 Days Post-Implant or Discharge, Whichever Is Longer
175
Table 6.37 Primary Endpoint - Sensitivity Analyses
175
Clinical Experience for Systemic Anticoagulation of Impella Patients Using Direct Thrombin Inhibitors
177
Patient Management Topics
178
Patient Management Overview
180
The Need for Early Identification of Cardiogenic Shock Patients
180
Table 7.1 Clinical Society Guidelines for Impella Therapy
181
General Patient Care Considerations
182
Transport Within the Hospital
182
Right Heart Failure
183
ECG Interference
183
Latex
183
Use of Echocardiography for Positioning of the Impella Catheter
183
Understanding and Managing Impella Catheter Position Alarms
190
Impella Stopped
197
Suction
197
Hemolysis
197
Table 7.2 Guide for Managing Hemolysis in Various Circumstances
198
Responding to Rising Impella Motor Current
199
Enabling Purge Flow Notifications
199
Table 7.3 Threshold Motor Currents
199
Disabling Audio Alarms
200
Surgical Mode
200
Operating the Impella Catheter Without Heparin in the Purge Solution
200
Timed Data Recording
201
Operating the Impella Catheter in Electromagnetic Fields
201
Table 7.4 Troubleshooting When Operating the Impella Catheter
201
Table 7.5 Troubleshooting When Operating the Impella Catheter in the Presence of a MNS System
202
Transferring from the Automated Impella Controller to a New AIC
203
Emergency Shutdown Procedure
203
Anti-Coagulation Therapy with Impella Heparin Infusion
204
Table 7.6 Clinical Scenarios for Anti-Coagulation Therapy with the Impella Purge System Heparin (50 U/Ml)
205
Table 7.7 Patient Scenarios for Anti-Coagulation Therapy with the Impella Purge System Heparin (25 U/Ml)
206
Use of Intra-Aortic Balloon Pump with Impella Patients
207
Use of Impella in Patients with Transcatheter Aortic Valves
207
Automated Impella Controller Alarms
209
Alarms Overview
210
Alarm Levels
210
Alarm Message Summary
212
General System Information
217
Terminology, Abbreviations, and Symbols
218
Terminology and Abbreviations
218
Symbols (Continued)
218
Automated Impella Controller Mechanical Specifications
220
Automated Impella Controller Electrical Specifications
220
Automated Impella Controller
220
Equipment Design
221
Equipment Classifications
221
Federal Communications Commission (FCC) Notice
222
Electromagnetic Compatibility
222
Use of Extracorporeal Membrane Oxygenation (ECMO) with Impella Patients in Cardiogenic Shock
223
Transport between Hospitals
224
Specifications for Grounding Cable
225
VGA Monitor Connection
230
Alarm Delay Information
231
Patient Environment
231
Use Environment
231
Impella Catheter Parameters
232
Technical Specifications
233
Impella 5.5 with Smartassist Catheter Dimensions
233
Cleaning
234
Storing the Automated Impella Controller
234
Returning an Impella Catheter to Abiomed (United States)
234
Appendices
235
Appendix A: Impella Ventricular Support Systems Limited Service Warranty (United States)
236
Appendix B: Automated Impella Controller Menu Structure
238

Abiomed Impella 5.5 User Manual (88 pages)

Circulatory Support System with SmartAssist

Brand: Abiomed | Category: Medical Equipment | Size: 16 MB

Intended Audience
3
Purge Cassette
5
Pre-Support Evaluation
6
Case Start
6
Positioning and Starting the Impella
11
Purge Cassette Procedures
13
Patient Weaning
14
Alarms Overview
16
Aperçu Général
56

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