USER MANUALGEBRAUCHSANWEISUNGMANUAL DEL USUARIOMANUALE D'USOMANUEL D'UTILISATIONANVÄNDARHANDBOKGEBRUIKERSHANDLEIDINGBRUGERVEJLEDNINGBRUKERMANUALUŽIVATELSKÁ PŘÍRUČKAINSTRUKCJA OBSŁUGIKÄYTTÖOHJEMANUAL DO UTILIZADORImpella LD®Circulatory Support System

Abiomed Impella LD User Manual

instructions for use

Warnings

Indications (United States)

Potential Adverse Events (United States)

Cautions

Overview

Table 3.1 Impella ® Set-up and Insertion Kit Components

Impella ® Catheter

Table 3.3 Impella ® Catheter Components

Figure 3.6 Electrical Signal Generated by the Cardiac Cycle

Automated Impella ® Controller

Purge Cassette

Table 3.4 Purge Cassette Components

Accessories

Figure 3.16 Placement Guidewire

Controller Features – Front View

Controller Features – Side Views

Home Screen

Placement Screen

Purge Screen

Infusion History Screen

Mobile Operation

Pre-support Evaluation

Startup

Case Start

Figure 5.5 Inserting the Catheter Plug into the Connector Cable

Figure 5.7 Priming the Impella Purge Lumen

Figure 5.9 Priming the Placement Signal Lumen

Figure 5.11 Entering Purge Fluid Information

Figure 5.12 Connecting the Purge Tubing to the Connector Cable

Impella ® 2.5 Catheter Insertion (Wired)

Figure 5.15 Inserting the Diagnostic Catheter

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 5.21 Inserting the Diagnostic Catheter

EasyGuide Lumen and Aligning the Placement Guidewire

Figure 5.25 Aortic Waveform on Placement Screen

Catheter

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

a Sidearm Graft

Figure 5.34 Waveform as Catheter is Advanced into the Aorta

Figure 5.35 Pulsatile Waveform on Placement Signal Screen

Catheters

Figure 5.38 Ventricular Waveform on Placement Signal Screen

Figure 5.40 Adjusting P-level

from the Set-up Conﬁguration

Figure 5.43 Waveform as Catheter is Advanced into the Aorta

Figure 5.44 Pulsatile Waveform on Placement Screen

Figure 5.46 Conﬁrming Placement on the Placement Signal Screen

Figure 5.47 Selecting P-Level

Figure 5.48 Conﬁrming Placement on the Placement Signal Screen

LD Catheter After Implantation

Purge Cassette Procedures

Tubing

Troubleshooting the Purge System

Patient Weaning

Figure 5.53 Loosening the Tuohy-Borst Valve

Summary of Primary Clinical Studies

Table 6.1 Baseline Demographics and Characteristics

Figure

Summary of Supplemental Clinical Information

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

Figure 6.15 RECOVER I Enrollment

Figure 6.16 Kaplan-Meier Survival Curve for Freedom from Death (to 1 Year)

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

Patient Management Overview

Transport Within the Hospital

ECG Interference

Impella Stopped

Hemolysis

Table 7.1 Guide for Managing Hemolysis in Various Circumstances

Figure 7.13 Displacing Air During Flush Solution Change Out Procedure

Surgical Mode

Transferring from the Automated Impella ® Controller to a New Automated Impella ® Controller