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Impella LD
Abiomed Impella LD Manuals
Manuals and User Guides for Abiomed Impella LD. We have
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Abiomed Impella LD manuals available for free PDF download: Instructions For Use Manual, User Manual
Abiomed Impella LD Instructions For Use Manual (211 pages)
Brand:
Abiomed
| Category:
Medical Equipment
| Size: 13.11 MB
Table of Contents
Table of Contents
5
Instructions for Use
3
Introduction
9
1 Indications, Contraindications, and Potential Adverse Events
11
Indications (United States)
13
Contraindications (United States)
13
Potential Adverse Events (United States)
14
2 Warnings and Cautions
15
Warnings
17
Cautions
19
3 The Impella ® Catheter and Automated Impella ® Controller
21
Overview
23
Figure 3.1 Impella ® Catheter in the Heart
23
Impella CP ® Catheter, and Accessories
24
Table 3.1 Impella ® Set-Up and Insertion Kit Components
24
Figure 3.3 Set-Up Configuration of the Automated Impella ® Controller, Impella
26
Impella ® Catheter
27
Impella
27
Figure 3.4 Impella ® Catheters
27
Table 3.3 Impella ® Catheter Components
29
And LD Differential Pressure Sensor (Impella ® 5.0 Shown)
31
Figure 3.6 Electrical Signal Generated by the Cardiac Cycle
31
Placement Signal
32
Automated Impella ® Controller
33
Figure 3.9 Automated Impella Controller - Front View
33
Purge Cassette
34
Figure 3.10 Purge Cassette
34
Table 3.4 Purge Cassette Components
35
Accessories
36
Figure 3.11 White Connector Cable
36
Figure 3.13 Impella CP ® Introducer Kit
36
Figure 3.14 Silicone Plugs (Impella ® 5.0/LD)
36
Figure 3.15 Impella ® Axillary Insertion Kit (Impella ® 2.5, 5.0, and Impella CP ® )
37
Figure 3.16 Placement Guidewire
37
Figure 3.17 Dextrose Solution
37
Figure 3.18 Automated Impella Controller Cart
37
4 Using the Automated Impella ® Controller
39
Overview
41
Automated Impella ® Controller Features
42
Figure 4.1 Automated Impella Controller Features - Front View
42
Figure 4.2 Automated Impella ® Controller Features - Side Views
44
Home Screen
46
Figure 4.3 Home Screen
46
Placement Screen
49
Figure 4.4 Placement Screen
49
Purge Screen
50
Figure 4.5 Purge Screen
50
Infusion History Screen
51
Mobile Operation
52
Figure 4.6 Infusion History Screen
52
5 Using the Automated Impella ® Controller with the Impella ® Catheter
53
Figure 3.5 Impella
53
Pre-Support Evaluation
55
Startup
56
Figure 5.1 Automated Impella Controller Power Switch
57
Figure 5.2 Automated Impella ® Controller Startup Screen
58
Case Start
59
Figure 5.3 Initial Case Start Screen
59
Figure 5.4 Inserting Purge Cassette into Automated Impella ® Controller
60
Figure 5.5 Inserting the Catheter Plug into the Connector Cable
61
Figure 5.6 Snapping Plastic Clip to Connector Cable (Impella CP Shown)
61
Figure 5.7 Priming the Impella Purge Lumen
62
Figure 5.9 Priming the Placement Signal Lumen
63
Figure 5.10 Squeezing the White Flush Valve to Prime the Placement
63
Figure 5.11 Entering Purge Fluid Information
64
Figure 5.12 Connecting the Purge Tubing to the Connector Cable
65
Figure 5.13 Set-Up Configuration of the Impella ® System
65
Impella ® 2.5 Catheter Insertion (Wired)
66
Figure 5.14 Inserting the Peel-Away Introducer
66
Figure 5.15 Inserting the Diagnostic Catheter
67
Figure 5.16 Loading the Catheter on the Guidewire Using the Easyguide Lumen
67
Figure 5.17 Loading the Catheter on the Guidewire Without the Easyguide Lumen and Aligning the Placement Guidewire
68
Figure 5.19 Aortic Waveform on Placement Signal Screen
69
Wireless Insertion of the Impella ® 2.5 Catheter
70
Impella CP ® Catheter Insertion
71
Figure 5.20 Inserting the Peel-Away Introducer
71
Figure 5.21 Inserting the Diagnostic Catheter
72
Figure 5.22 Loading the Catheter on the Guidewire Using the Easyguide Lumen
72
Figure 5.23 Loading the Catheter on the Guidewire Without the Easyguide Lumen and Aligning the Placement Guidewire
73
Figure 5.24 Inserting the Impella ® Catheter
74
Figure 5.25 Aortic Waveform on Placement Screen
74
Axillary Insertion of the Impella ® 2.5, 5.0, or Impella CP ® Catheter
75
Figure 5.26 Introducer, Graft Lock, and Hemashield Platinum Graft (Graft Not Supplied)
76
Figure 5.27 Correct Positioning if Second Graft Lock Required
76
Figure 5.28 Closing the Graft Lock
77
Figure 5.29 Releasing the Graft Lock
78
Alternate Insertion Technique for the Impella ® 5.0 Catheter
79
Figure 5.31 Guidewire Placement
80
Figure 5.32 Femoral Artery Insertion of the Impella ® 5.0 Catheter Using
81
Implanting and Starting the Impella ® LD Catheter
83
Figure 5.33 Impella ® LD Catheter with Silicone Plugs
84
Figure 5.34 Waveform as Catheter Is Advanced into the Aorta
84
Figure 5.35 Pulsatile Waveform on Placement Signal Screen
85
Positioning and Starting the Impella ® 2.5 and Impella CP ® Catheters
86
Figure 5.36 Starting the Impella
86
Figure 5.38 Ventricular Waveform on Placement Signal Screen
87
Figure 5.39 Transfer to P-Level Mode
87
Figure 5.40 Adjusting P-Level
89
Figure 5.41 Removing the Peel-Away Introducer (14 Fr Introducer Shown)
89
Figure 5.42 Standard Configuration for Impella ® System after Transfer
91
From the Set-Up Configuration
91
Positioning and Starting the Impella ® 5.0 Catheter
92
Positioning and Starting the Impella ® LD Catheter
92
Figure 5.43 Waveform as Catheter Is Advanced into the Aorta
92
Figure 5.44 Pulsatile Waveform on Placement Screen
93
Figure 5.45 Selecting P-Level
93
Figure 5.46 Confirming Placement on the Placement Signal Screen
94
Device
94
Figure 5.47 Selecting P-Level
95
Figure 5.48 Confirming Placement on the Placement Signal Screen
96
Figure 5.49 Impella ® LD Catheter after Implantation
97
Purge Cassette Procedures
98
Figure 5.50 Disconnecting the y Connector from the Purge Cassette
99
Tubing
99
Troubleshooting the Purge System
102
Patient Weaning
103
Removing the Impella ® 2.5, 5.0, or Impella CP ® Catheter
104
Figure 5.51 Removing the Stylet
105
Figure 5.52 Inserting the Guidewire with the Cheater
105
Figure 5.53 Loosening the Tuohy-Borst Valve
105
Explanting the Impella ® LD Catheter
106
6 Clinical Experience
107
Cardiac Shock after Myocardial Infarction
109
Summary of Primary Clinical Studies
109
Table 6.1 Baseline Demographics and Characteristics
111
Figure 6.1 Kaplan-Meier Survival Curves Survival (to 30 Days) for the ISAR-SHOCK Trial
112
Cohort
112
Figure 6.2 Lactate Levels Seen Post-Implant During the Trial
113
Figure 6.3 Increase in Cardiac Index from Baseline, Impella Vs. IABP
113
Figure 6.4 Change in Inotropic Dosage at 24 Hours, Impella Vs. IABP
114
Summary of Supplemental Clinical Information
115
Figure 6.5 Time Intervals for Impella Implants Data Collection by Type of
116
Figure 6.6 Kaplan-Meier Curve Estimates for 30 Day Survival - All Patient
117
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)
118
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)
119
Figure 6.11 Kaplan-Meier Curve Estimates for 30-Day Survival
120
Figure 6.14 Decrease in Inotropes and Pressors (Post-Device Placement) for RECOVER I Patients
123
Cardiac Shock after Open Heart Surgery
125
Summary of Primary Clinical Studies
125
Figure 6.15 RECOVER I Enrollment
127
Figure 6.16 Kaplan-Meier Survival Curve for Freedom from Death (to 1 Year)
129
Summary of Supplemental Clinical Information
131
Figure
132
Figure
133
Figure 6.27 Flow Diagram of the Distribution of the AB5000 LVAD PCCS Patient Cohort
136
Figure 6.30 Decrease in Inotropes and Pressors (Post-Device Placement) for RECOVER I Patients
139
7 Patient Management Topics
140
General Patient Care Considerations
142
Patient Management Overview
142
Transport Within the Hospital
143
Right Heart Failure
143
ECG Interference
144
Latex
144
Use of Echocardiography for Positioning of the Impella ® Catheter
144
Background
144
Correct Impella ® Catheter Position
146
Impella ® Catheter too Far into the Left Ventricle
146
Impella ® Catheter Inlet in the Aorta
147
Impella ® Catheter in Papillary Muscle
147
Color Doppler Echocardiography
150
Understanding and Managing Impella ® Catheter Position Alarms
151
Post-Insertion Positioning (PIP) Checklist
151
Correct Position
152
Impella CP Catheter Fully in Ventricle ....................................7.12
153
Outlet Areas in Ventricle and Open Pressure Area in Aorta
154
And Impella
155
Impella
155
Low Native Heart Pulsatility (Impella ® 5.0 and
155
Impella Stopped
159
Suction
159
Suction with the Impella ® 2.5 or Impella CP Catheter
159
Hemolysis
160
Table 7.1 Guide for Managing Hemolysis in Various Circumstances
161
Operating the Impella ® Catheter Without Heparin in the Purge Solution
162
Placement Signal Lumen (for Impella ® 2.5 and Impella CP ® )
162
Placement Signal Lumen (for Impella ® 2.5 and Impella
163
Flush Solution Change out Procedure
163
Figure 7.13 Displacing Air During Flush Solution Change out Procedure
163
Pressure Sensor Drift and Sensor Failure (for Impella ® 5.0 and LD)
164
Pressure Sensor Drift and Sensor Failure (for Impella ® 5.0 and
164
Manually Zeroing the Differential Pressure Sensor
164
Sensor Failure and Effects on Flow Calculations
164
Sensor Failure and Effects on Position Control
164
Disabling Audio for Placement Signal Lumen Blocked Alarm (Impella ® 2.5 and Impella
165
Enabling Purge Flow Notifications
165
Enabling Purge Flow Notifications
165
Disabling Audio for Placement Signal Lumen Blocked Alarm (Impella ® 2.5 and Impella CP ® )
165
Suction Detection During Sensor Drift or Sensor Failure
165
Surgical Mode
166
Timed Data Recording
166
Operating the Impella ® Catheter in Electromagnetic Fields
167
Electroanatomic Mapping (EAM) Systems
167
Magnetic Navigation Systems (MNS)
168
Transferring from the Automated Impella Controller to a New Automated Impella Controller
169
Transfer Steps
169
Patient Management Checklist Following Transfer of Support
169
Emergency Shutdown Procedure
170
8 Automated Impella Controller® Alarms
172
8 Automated Impella ® Controller Alarms
172
Alarms Overview
174
Alarm Levels
174
Alarm Display
175
Mute Alarm Function
175
Alarm History Screen
175
Figure 8.1 Alarm Window
175
Alarm Message Summary
176
9 General System Information
182
Terminology, Abbreviations, and Symbols
184
Terminology and Abbreviations
184
Symbols
184
Equipment Design
187
Equipment Classifications
188
Equipment Classifications
188
Federal Communications Commission (FCC) Notice
188
Electromagnetic Compatibility
189
Transport between Hospitals
190
Guidelines for Patient Transport
190
FAA Advisory
191
Important Transport Considerations
191
Vga Monitor Connection
194
Alarm Delay Information
195
Patient Environment
195
White Connector Cable
196
Impella ® Catheter Parameters
196
Impella CP ® Catheter Dimensions
197
Impella ® 2.5 Catheter Dimensions
197
Impella ® 5.0 Catheter Dimensions
197
Impella ® 5.0 Catheter Dimensions
198
Impella ® LD Catheter Dimensions
198
Cleaning
199
Storing the Automated Impella ® Controller
199
Appendices
200
Appendix A: Impellasystem Limited Service Warranty (United States)
204
Appendix B: Abiomed-Approved Guidewires and Introducers (Impella ® 2.5 and Impella CP ® )
204
Appendix C: Automated Impella ® Controller Menu Structure
206
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Abiomed Impella LD User Manual (176 pages)
Circulatory Support System
Brand:
Abiomed
| Category:
Medical Equipment
| Size: 35.43 MB
Table of Contents
Intended Audience
3
Purge Cassette
5
Case Start
6
Purge Cassette Procedures
9
Patient Weaning
10
Alarms Overview
12
White Connector Cable
13
Impella Ld ® Catheter Dimensions
14
Descripción General
32
Puesta en Marcha
34
Descrizione Generale
46
Aperçu Général
60
Cílová Skupina
125
Informacje Ogólne
138
Pierwsze Kroki
140
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