Abiomed Impella RP Manuals

Manuals and User Guides for Abiomed Impella RP. We have 1 Abiomed Impella RP manual available for free PDF download: Instructions For Use & Clinical Reference Manual

Abiomed Impella RP Instructions For Use & Clinical Reference Manual (97 pages)

with the Automated Impella Controller Circulatory Support System

Brand: Abiomed | Category: Medical Equipment | Size: 6 MB

Table of Contents

4
3 The Impella® Rp Catheter and Automated Impella® Controller

15
- Overview
  
  16
  - Figure 3.1 Impella RP Catheter in the Heart
    16
  - RP Catheter and Automated Impella
    16
  - Controller
    16
    
    Impella® RP Catheter
    17
    
    Reusable System Components
    17
    
    Single-Use System Components
    17
    
    System Configuration
    17
    
    Impella ® Rp Catheter
    18
    
    Differential Pressure Sensor
    19
- Automated Impella Controller
  
  20
  - Figure 3.4 Automated Impella Controller - Front View
    20
- Purge Cassette
  
  21
  - Figure 3.5 Purge Cassette
    21
  - Table 3.2 Purge Cassette Components
    22
- Accessories
  
  23
4 Using the Automated Impella ® Controller

25
- 4 Using the Automated Impella Controller
  25
  - Overview
    26
  - Automated Impella ® Controller Features
    26
  - Controller Features – Front View
    26
  - Figure 4.2 Automated Impella ® Controller Features - Side Views
    28
  - Automated Impella ® Controller Display
    30
  - Figure 4.3 Automated Impella ® Controller Display Elements
    30
  - Placement Screen
    33
  - Figure 4.4 Placement Screen
    33
    
    Placement Signal Waveform
    33
  - Purge Screen
    34
  - Figure 4.5 Purge Screen
    34
    
    Motor Current Waveform
    34
  - Infusion History
    35
    
    Purge Flow
    35
    
    Purge Pressure
    35
  - Mobile Operation
    36
  - Figure 4.6 Infusion History Screen
    36
Rp Catheter®

37
6 Clinical Experience

58
- Pivotal Clinical Study Design - RECOVER RIGHT
  
  59
  - Inclusion and Exclusion Criteria
    59
- Accountability of Cohort
  
  61
  - Figure 6.1 Study Flow Schematic
    61
    
    Statistical Considerations
    61
    
    Study Organization
    61
    
    Study Population Demographics and Baseline Characteristics
    62
    
    Procedural, Support and Hemodynamic Characteristics
    63
    
    Primary Endpoint Results
    65
    
    Secondary Effectiveness Endpoint Results
    65
    
    Secondary Safety Endpoint Results
    65
    
    Figure 6.3 LVAD Flow Changes from Baseline to On-Support
    66
    
    Figure 6.4 Use of Inotropes During Impella RP Support
    67
    
    Other Relevant Clinical Findings
    67
    
    Figure 6.5 Right Ventricular Function Changes
    68
    
    Trial Conclusions
    68
7 Automated Impella® Controller Alarms

70
- 7 Automated Impella Controller Alarms
  
  70
- Alarms Overview
  
  71
  - Alarm Levels
    71
  - Figure 7.1 Alarm Window
    72
  - Alarm Display
    72
  - Mute Alarm Function
    72
- Alarm Message Summary
  
  73
8 General System Information

77

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Abiomed Impella RP Manuals

Abiomed Impella RP Instructions For Use & Clinical Reference Manual (97 pages)

Table of Contents

Table of Contents

1 Indications, Contraindications, and Potential Adverse Events

2 Warnings and Cautions

3 The Impella® Rp Catheter and Automated Impella® Controller

Overview

Automated Impella Controller

Purge Cassette

Accessories

4 Using the Automated Impella ® Controller

Rp Catheter®

5 Using the Automated Impella Controller with the Impella Rp Catheter

Startup

Case Start

Inserting the Impella ® Rp Catheter

Positioning and Starting the Impella ® Rp Catheter

Use of the Repositioning Sheath and the 23 Fr Peel-Away Introducer

Purge Cassette Procedures

Troubleshooting the Purge System

Patient Weaning

6 Clinical Experience

Pivotal Clinical Study Design - RECOVER RIGHT

Accountability of Cohort

7 Automated Impella® Controller Alarms

7 Automated Impella Controller Alarms

Alarms Overview

Alarm Message Summary

8 General System Information

Appendices

Appendix A: Automated Impella Controller Menu Structure

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