Impella RP Instructions for Use and Clinical Reference Manual Rev C Aug 2016

IMPORTANT NOTICE: Read this entire manual before using the Automated Impella® Controller and Impella RP® Circulatory Support System (Impella RP® System). The Impella RP® System is to be used only in accordance with this manual. This manual is only applicable to Impella® systems using the Automated Impella® Controller. Information contained in this document is subject to change without notice. ©2016 Abiomed®, Inc. All rights reserved. The ABIOMED logo and ABIOMED are registered trademarks of Abiomed, Inc. in the U.S.A. and certain foreign countries. Recovering hearts. Saving lives. is a trademark of Abiomed, Inc. Impella is a registered trademark of Abiomed Europe GmbH, a wholly owned subsidiary of Abiomed, Inc., in the U.S.A. and certain foreign countries.

IMPELLA RP® WITH THE AUTOMATED IMPELLA® CONTROLLER INSTRUCTIONS FOR USE & CLINICAL REFERENCE MANUAL (UNITED STATES ONLY)

Rx Only

Abiomed, Inc. 22 Cherry Hill Drive Danvers, MA 01923 978-777-5410 (voice) 978-777-8411 (fax) [email protected] (email) Abiomed Europe GmbH Neuenhofer Weg 3 52074 Aachen, Germany +49 (241) 8860-0 (voice) +49 (241) 8860-111 (fax) [email protected] (email) www.abiomed.com 24-Hour Emergency Hotlines: N. America 1-800-422-8666 Europe +49 (0) 1805 2246633 August 2016 Document No. 0046-9051 Rev. C

TABLE OF CONTENTS INTRODUCTION Introduction... I 1 INDICATIONS, CONTRAINDICATIONS, AND POTENTIAL ADVERSE EVENTS Indications (United States)... 1.1 Contraindications (United States)... 1.1 Potential Adverse Events (United States)... 1.2 2 WARNINGS AND CAUTIONS Warnings... 2.1 Cautions... 2.3 3 THE IMPELLA RP® CATHETER AND AUTOMATED IMPELLA® CONTROLLER Overview... 3.1 Impella RP® Catheter... 3.3 Automated Impella® Controller... 3.5 Purge Cassette... 3.6 Accessories... 3.8 4 USING THE AUTOMATED IMPELLA® CONTROLLER Overview... 4.1 Automated Impella® Controller Features... 4.1 Automated Impella® Controller Display... 4.5 Placement Screen... 4.8 Purge Screen... 4.9 Infusion History... 4.10 Mobile Operation... 4.11 5 USING THE AUTOMATED IMPELLA® CONTROLLER WITH THE IMPELLA RP® CATHETER Startup... 5.1 Case Start... 5.4 Inserting the Impella RP® Catheter... 5.10 Positioning and Starting the Impella RP® Catheter... 5.12 Use of the Repositioning Sheath and the 23 Fr Peel-away Introducer... 5.13 Performance Levels... 5.14 Suction... 5.14 Purge Cassette Procedures... 5.15 Troubleshooting the Purge System... 5.18 Patient Weaning... 5.20 Removing the Impella RP® Catheter... 5.20 6 CLINICAL EXPERIENCE Pivotal Clinical Study Design – RECOVER RIGHT... 6.1 Accountability of Cohort... 6.4

7 AUTOMATED IMPELLA® CONTROLLER ALARMS Alarms Overview... 7.1 Alarm Message Summary... 7.3 8 GENERAL SYSTEM INFORMATION Terminology, Abbreviations, and Symbols... 8.1 Automated Impella® Controller Mechanical Specifications... 8.3 Automated Impella® Controller Electrical Specifications... 8.3 Equipment Design... 8.4 Equipment Classifications... 8.5 Federal Communications Commission (FCC) Notice... 8.5 Electromagnetic Compatibility... 8.6 Transport Between Hospitals... 8.10 Transport Within the Hospital... 8.11 Slave Monitor Connection... 8.11 Alarm Delay Information... 8.12 Patient Environment... 8.12 White Connector Cable... 8.13 Impella RP® Catheter Parameters... 8.13 Cleaning... 8.14 Storing the Automated Impella® Controller... 8.14 Returning an Impella RP® Catheter to Abiomed (United States)... 8.14 APPENDICES Appendix A: Automated Impella® Controller Menu Structure... A.1

TABLE OF CONTENTS FIGURES Figure 3.1 Figure 3.2

Impella RP® Catheter in the Heart... 3.1 Automated Impella® Controller, Impella RP® Catheter, and Accessories... 3.2 Figure 3.3 Impella RP® Catheter... 3.3 Figure 3.4 Automated Impella® Controller – Front View... 3.5 Figure 3.5 Purge Cassette... 3.6 Figure 3.6 White Connector Cable... 3.8 Figure 3.7 Introducer kit... 3.8 Figure 3.8 0.025 inch, 260 cm Placement Guidewire... 3.8 Figure 3.9 Dextrose Solution... 3.9 Figure 3.10 Automated Impella® Controller Cart... 3.9 Figure 4.1 Automated Impella® Controller Features – Front View... 4.1 Figure 4.2 Automated Impella® Controller Features – Side Views... 4.3 Figure 4.3 Automated Impella® Controller Display Elements... 4.5 Figure 4.4 Placement Screen... 4.8 Figure 4.5 Purge Screen... 4.9 Figure 4.6 Infusion History Screen... 4.11 Figure 5.1 Automated Impella® Controller Power Switch... 5.2 Figure 5.2 Automated Impella® Controller Startup Screen... 5.3 Figure 5.3 Initial Case Start Screen... 5.4 Figure 5.4 Inserting the Purge Cassette into the Automated Impella® Controller... 5.5 Figure 5.5 Inserting the Catheter Plug into the Connector Cable... 5.6 Figure 5.6 Snapping Purge Clip to Connector Cable... 5.6 Figure 5.7 Connecting the Luer to the Impella RP® Catheter... 5.7 Figure 5.8 Priming the Purge... 5.8 Figure 5.9 Entering Purge Fluid Information... 5.8 Figure 5.10 Connecting the Purge Tubing to the Connector Cable... 5.9 Figure 5.11 Impella RP® System Configuration... 5.9 Figure 5.12 Maximum Performance Level... 5.12 Figure 5.13 Disconnecting the Y Connector from the Purge Cassette Tubing... 5.15 Figure 6.1 Study Flow Schematic... 6.4 Figure 6.2 Cardiac Index (CI) and Central Venous Pressure (CVP) Measured During the Study... 6.9 Figure 6.3 LVAD Flow Changes from Baseline to On-support... 6.10 Figure 6.4 Use of Inotropes During Impella RP® Support... 6.10 Figure 6.5 Right Ventricular Function Changes from Baseline to 30 Days or Discharge... 6.11 Figure 7.1 Alarm Window... 7.2 Figure 8.1 Automated Impella® Controller Patient Environment... 8.12

TABLES Table 3.1 Impella RP® Catheter Components... 3.3 Table 3.2 Purge Cassette Components... 3.7 Table 3.3 Impella RP® Catheter and Automated Impella® Controller Accessories 3.8 Table 4.1 Automated Impella® Controller Front View Features... 4.2 Table 4.2 Automated Impella® Controller Side View Features... 4.4 Table 4.3 Automated Impella® Controller Display Elements... 4.5 Table 5.1 Performance Level Flow Rates... 5.14 Table 6.1 Patient Characteristics... 6.5 Table 6.2 Baseline Laboratory Parameters... 6.6 Table 6.3 Procedural Characteristics... 6.7 Table 6.4 Support and Hemodynamic Characteristics... 6.7 Table 6.5 Patient Outcomes... 6.8 Table 6.6 Secondary Safety Endpoints... 6.8 Table 7.1 Alarm Levels... 7.1 Table 7.2 Automated Impella® Controller Alarm Messages... 7.3 Table 8.1 Terminology and Abbreviations... 8.1 Table 8.2 Symbols... 8.1 Table 8.3 Mechanical specifications for the Automated Impella Controller... 8.3 Table 8.4 Electrical specifications for the Automated Impella Controller... 8.3 Table 8.5 Equipment classifications... 8.5 Table 8.6 Guidance and manufacturer’s declaration - emissions, all equipment and systems... 8.6 Table 8.7 Guidance and manufacturer’s Declaration - Immunity... 8.7 Table 8.8 Guidance and manufacturer’s declaration - emissions, equipment and systems that are life-supporting... 8.8 Table 8.10 RFID transmitter / receiver specifications... 8.9 Table 8.9 Recommended separation distances between portable and mobile RF communications equipment and the Authomated Impella Controller, equipment and systems that are life-supporting... 8.9 Table 8.11 Alarm Delay Information... 8.12 Table 8.12 Impella Catheter Parameters... 8.13

INTRODUCTION INTRODUCTION

PURPOSE OF MANUAL This Instructions for Use & Clinical Reference Manual is designed for healthcare professionals. It contains clinical and technical information to guide healthcare professionals in their use of the Impella RP® Catheter with the Automated Impella® Controller. The Impella RP® System performs life-sustaining functions. To use the system you must understand and follow these instructions. The Impella RP® System may be used only for its intended purpose. MANUAL OVERVIEW This manual provides instructions for use of the Impella RP® Catheter with the Automated Impella® Controller. The following summarizes the contents of each section of the manual. • S ection 1: Indications, Contraindications, and Potential Adverse Events discusses indications for use of the Impella® RP Catheter with the Automated Impella® Controller, contraindications, and potential adverse events that may be associated with the use of the system. • S ection 2: Warnings and Cautions discusses the warnings and cautions pertaining to the use of the Impella RP® Catheter with the Automated Impella® Controller. • S ection 3: The Impella RP® Catheter and Automated Impella® Controller provides an overview of the system and describes its major components and features. • S ection 4: Using the Automated Impella® Controller describes the controls and various screen types on the Automated Impella® Controller. • Section 5: Using the Automated Impella® Controller with the Impella RP® Catheter provides the procedures for using the Impella RP® System. • Section 6: Clinical Experience provides an overview of the RECOVER RIGHT trial, which studied the use of the Impella RP® System in a U.S. clinical trial. The results of this trial were reviewed by the FDA prior to its approval of the Impella RP® System. • S ection 7: Automated Impella® Controller Alarms provides a listing of Automated Impella® Controller alarms as well as information on what to do to resolve them. • S ection 8: General System Information contains information including definitions for key terms that appear in the manual, descriptions of the abbreviations and symbols that appear on Impella RP® Catheter and Automated Impella® Controller components and packaging, technical information pertaining to the Impella RP® Catheter and Automated Impella® Controller, and instructions on cleaning and storing system components as well as returning components to Abiomed. •A  ppendices at the end of the manual provide supplemental information about topics including the Automated Impella® Controller menu structure.

Impella RP® with the Automated Impella® Controller

I

1 INDICATIONS, CONTRAINDICATIONS, AND POTENTIAL ADVERSE EVENTS

INDICATIONS (UNITED STATES)... 1.1 CONTRAINDICATIONS (UNITED STATES)... 1.1 POTENTIAL ADVERSE EVENTS (UNITED STATES)...1.2

INDICATIONS (UNITED STATES) 1 INDICATIONS, CONTRAINDICATIONS, AND POTENTIAL ADVERSE EVENTS

The Impella RP® System is indicated for providing circulatory assistance for up to 14 days in pediatric or adult patients with a body surface area ≥ 1.5 m2 who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

CONTRAINDICATIONS (UNITED STATES) • Disorders of the pulmonary artery wall that would preclude placement or correct positioning of the Impella RP® device • Mechanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid valve or pulmonary valve • Mural thrombus of the right atrium or vena cava • Anatomic conditions precluding insertion of the pump • Other illnesses or therapy requirements precluding use of the pump • Presence of a vena caval filter or caval interruption device, unless there is clear access from the femoral vein to the right atrium that is large enough to accommodate a 22 Fr catheter

Impella RP® with the Automated Impella® Controller

1.1

POTENTIAL ADVERSE EVENTS (UNITED STATES) Below is a list of the potential adverse effects (eg, complications) associated with the use of the Impella RP® System: • Arrhythmia • Atrial fibrillation • Bleeding • Cardiac tamponade • Cardiogenic shock • Death • Device Malfunction • Hemolysis • Hepatic failure • Insertion site infection • Perforation • Phlegmasia cerulea dolens (a severe form of deep venous thrombosis) • Pulmonary valve insufficiency • Respiratory dysfunction • Sepsis • Thrombocytopenia • Thrombotic vascular (non-central nervous system) complication • Tricuspid valve injury • Vascular injury • Venous thrombosis • Ventricular fibrillation and/or tachycardia

1.2

Instructions for Use & Clinical Reference Manual (US)

2 WARNINGS AND CAUTIONS

WARNINGS...2.1 CAUTIONS... 2.3

WARNINGS 2

Fluoroscopy is required to guide placement of the Impella RP® Catheter. The small placement guidewire must be reliably observed at all times. Be sure that the stopcock on the repositioning sheath is always kept in the closed position. Significant bleed back can result if the stopcock is open.

Warnings Warnings alert you to situations that can cause death or serious injury. The red symbol appears before warning messages.

Avoid manual compression of the inlet, outlet, or sensor areas of the cannula assembly. The sterile components of the Impella RP® System can be used only if the sterilization indicators show that the contents have been sterilized, the packaging is not damaged, and the expiration date has not elapsed. Do NOT resterilize or reuse the Impella RP® Catheter. It is a disposable device and is intended for single use only. Reuse, reprocessing, reinserting through the introducer, or resterilization may compromise the structural integrity of the catheter and/or lead to catheter failure which, in turn, may result in patient injury, illness, or death. Retrograde flow will occur from the pulmonary artery back into the inferior vena cava if the Impella RP® Catheter is set at performance level P0. Do NOT use saline in the purge system. Do NOT use an Impella RP® System if any part of the system is damaged. To prevent the risk of explosion, do NOT operate the Impella RP® System near flammable anesthetics. If at any time during the course of support with the Impella RP® Catheter, the Automated Impella® Controller alarms “Purge Pressure Low” or “Purge System Open,” follow the instructions presented in section 5 of this manual. MR Unsafe - Do NOT subject a patient who has been implanted with an Impella RP® Catheter to magnetic resonance imaging (MRI). The strong magnetic energy produced by an MRI machine may cause the Impella RP® System components to stop working, and result in injuries to the patient. An MRI may also damage the Impella RP® System electronics. Cardiopulmonary support (CPR) should be initiated immediately per hospital protocol if indicated for any patient supported with the Impella RP® Catheter. When initiating CPR, reduce the Impella RP® Catheter flow rate. When cardiac function has been restored, return flow rate to the previous level and assess the placement signal on the controller. During defibrillation, do NOT touch the Impella RP® Catheter, cables, or Automated Impella® Controller.

Impella RP® with the Automated Impella® Controller

2.1

WARNINGS AND CAUTIONS

The Impella RP® System is intended for use only by personnel trained in accordance with the Abiomed Training Program.

Power the Automated Impella® Controller using its internal battery if the integrity of the protective earth conductor is questionable. Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the electromagnetic compatibility (EMC) information provided in section 8 of this manual. During transport, the Automated Impella® Controller may be exposed to stronger electromagnetic disturbance than during in-hospital use. Strong electromagnetic disturbance may cause the Automated Impella® Controller to display soft button menu selections that were not selected by the user. Operators should be aware that, under these conditions, the operating parameters are not affected. No user intervention is required. Monitor Impella RP® Catheter flow and patient hemodynamics to confirm normal operation. The condition will resolve itself once the Automated Impella® Controller is no longer exposed to the disturbance. Portable and mobile RF communications equipment can affect medical electrical equipment. The equipment or system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used. Use of cables, other than those sold by Abiomed, may result in increased emissions or decreased immunity of the Automated Impella® Controller. The Automated Impella® Controller uses RFID (radio frequency identification) to identify and communicate with the purge cassette. Other equipment may interfere with the Automated Impella® Controller even if that other equipment complies with CISPR emission requirements. Avoid overinserting the Impella RP® Catheter and possibly impinging the catheter tip against the walls of the vasculature, atrium, or ventricle. Torquing the catheter should be monitored carefully using fluoroscopy. Do NOT advance or withdraw the Impella RP® Catheter against resistance without using fluoroscopy to determine the cause of the resistance. Doing so could result in separation of the catheter or guidewire tip, damage to the catheter or vessel, or perforation.

2.2

Instructions for Use & Clinical Reference Manual (US)

CAUTIONS 2

Patients with tricuspid or pulmonary valve stenosis or insufficiency, and patients with prosthetic tricuspid or pulmonary valves, may be compromised by the use of the Impella RP® Catheter. Use only original accessories and replacement parts supplied by Abiomed.

Cautions Cautions indicate situations in which equipment may malfunction, be damaged, or cease to operate. The yellow symbol appears before caution messages.

Do NOT use damaged or contaminated connector cables. To prevent device failure, do NOT start the Impella RP® Catheter until the placement guidewire has been removed. Do NOT remove the Impella RP® Catheter over the length of the placement guidewire. When replacing the purge cassette, the replacement process must be completed within 2 minutes. The Impella RP® Catheter may be damaged if replacement takes longer than 2 minutes. To prevent malfunction of the Automated Impella® Controller, avoid long-term exposure to direct sunlight and excessive heat (40°C). To prevent overheating and improper operation, do NOT block the cooling vents of the Automated Impella® Controller while it is operating. Do NOT kink or clamp any part of the Impella RP® Catheter. Do NOT use the Impella RP® Catheter with a damaged or kinked introducer. Replace the introducer if a kink is observed. The Li-Ion batteries must be charged for 5 hours prior to system operation in order to meet the runtime requirement of 1 hour. Failure to do so will yield a shorter runtime. After being unplugged, the Automated Impella® Controller will operate for at least 60 minutes after the batteries have been fully charged. Minimize exposure of Impella RP® System components to sources of electromagnetic interference (EMI). Exposure to sources of EMI, such as cell phones and two-way radios, may cause operational interference. To clear interference, either increase the distance between system components and the EMI source or turn off the EMI source. Operation of Impella RP® System components may interfere with the operation of other devices. If interference occurs, increase the distance between the device and system components.

Impella RP® with the Automated Impella® Controller

2.3

WARNINGS AND CAUTIONS

Handle with care. The Impella RP® Catheter can be damaged during removal from packaging, preparation, insertion, and removal. Do NOT bend, pull, or place excess pressure on the catheter or mechanical components at any time.

Operation of the system without heparin in the purge solution has not been tested. In the event that a patient is intolerant to heparin, due to heparin-induced thrombocytopenia or bleeding, physicians should use their clinical judgment to assess the risks versus benefits of operating the Impella® System without heparin. If it is in the best interest of the patient to operate the system without heparin, the dextrose solution is still required, and physicians should consider systemic delivery of an alternative anticoagulant. Do NOT add any alternative anticoagulant (such as a direct thrombin inhibitor) to the purge fluid. The Impella® Catheter has not been tested with any alternative anticoagulants in the purge solution. Have a backup Automated Impella® Controller, purge cassette, connector cable, and Impella RP® Catheter available in the unlikely event of a device failure.

Do NOT use the bed mount as a handle. Insertion through the left femoral vein may result in repeated attempts to properly position the Impella RP®, which could cause excessive manipulation and pump damage. As a result, left femoral insertion should be avoided whenever possible.

2.4

Instructions for Use & Clinical Reference Manual (US)

3 THE IMPELLA RP® CATHETER AND AUTOMATED IMPELLA® CONTROLLER

OVERVIEW...3.1 Reusable System Components...3.2 Single-use System Components...3.2 System Configuration...3.2 IMPELLA RP® CATHETER... 3.3 Differential Pressure Sensor...3.4 AUTOMATED IMPELLA® CONTROLLER...3.5 PURGE CASSETTE...3.6 ACCESSORIES...3.8

OVERVIEW 3 THE IMPELLA RP® CATHETER AND AUTOMATED IMPELLA® CONTROLLER

The Impella RP® Catheter is an intracardiac microaxial blood pump that supports a patient’s pulmonary circulation. The Impella RP® Catheter is inserted percutaneously through the femoral vein and into the pulmonary artery (see Figure 3.1).

Outlet area in PA

Inlet area in IVC

Femoral Vein Insertion

Figure 3.1 Impella RP ® Catheter in the Heart

When properly positioned, the Impella RP® Catheter delivers blood from the inlet area, which sits in the inferior vena cava, through the cannula, to the outlet opening in the pulmonary artery. Physicians and device operators monitor Impella RP® Catheter function on the display screen of the Automated Impella® Controller. The intent of the therapy with the Impella RP® System is to provide a percutaneous circulatory support system to restore normal right heart hemodynamics, reduce right ventricular work, and allow the right heart time to potentially recover adequate contractile function or to be bridged to the next therapy. This section describes the components of the Impella RP® Catheter and the Automated Impella® Controller, as well as the accessory components.

Impella RP® with the Automated Impella® Controller

3.1

REUSABLE SYSTEM COMPONENTS The Impella RP® System consists of the following reusable components: • Automated Impella® Controller-provides the user interface, alarm indications, and portable battery • Automated Impella® Controller cart-for easy transport of the Automated Impella® Controller

SINGLE-USE SYSTEM COMPONENTS The Impella RP® System also includes the following single-use components: • Impella RP® Catheter • Purge cassette • Introducer kit • Connector cable

SYSTEM CONFIGURATION Figure 3.2 illustrates how the Automated Impella® Controller connects to the Impella RP® Catheter and accessory components. D20 D5

Disconnect Y Connector from Purge Tubing Dextrose Solution Automated Impella® Controller

Impella® RP Catheter Connector Cable

Purge Cassette

Connect Purge Tubing Directly to Impella® RP Catheter

Figure 3.2 Automated Impella® Controller, Impella RP ® Catheter, and Accessories

3.2

Instructions for Use & Clinical Reference Manual (US)

IMPELLA RP® CATHETER 3 THE IMPELLA RP® CATHETER AND AUTOMATED IMPELLA® CONTROLLER

The Impella RP® Catheter is an intracardiac microaxial blood pump that delivers up to 4.0 liters of blood per minute from the inferior vena cava into the pulmonary artery. Figure 3.3 illustrates the Impella RP® Catheter. The Impella RP® Catheter has a specially designed three dimensional cannula that is sized to fit through the vessels and hearts of pediatric and adult patients with a Body Surface Area (BSA) equal to or greater than 1.5 m2. Table 3.1 describes each component from the pigtail at one end to the check valve on the other end. Blue Impella® Plug Pigtail Clear Sidearm

Infusion Filter Pressure Reservoir

Outlet Area

Check Valve Catheter Shaft

Differential Pressure Sensor

Cannula

Inlet Area Motor Housing Repositioning Unit

Figure 3.3 Impella RP ® Catheter

Table 3.1 Impella RP ® Catheter Components

Component

Description

Pigtail

The 6 Fr pigtail is attached to the cannula at the distal end of the outlet area. It assists with stabilizing the catheter in the correct position in the pulmonary artery.

Outlet area

The outlet area, located at the distal tip of the cannula, has 5 openings (windows) that allow blood to exit the cannula.

Cannula

The 22 Fr cannula is designed for the anatomy of the right heart, to provide optimal and stable position during operation. The cannula is made of nitinol and covered in polyurethane with spiral shaped reinforcement integrated into the cannula.

Differential pressure sensor

A sensor that measures the pressure difference between the inside and outside of the cannula. The pressure value is used for monitoring flow during catheter operation.

Impella RP® with the Automated Impella® Controller

3.3

Table 3.1 Impella RP ® Catheter Components (continued)

Component

Description

Inlet area

The proximal end of the cannula is attached to the inlet area where blood enters the cannula.

Motor housing

The 21 Fr motor housing consists of an encapsulated motor.

Catheter shaft

An 11 Fr catheter shaft is located between the motor housing and the blue Impella® plug. The lumen of the catheter shaft contains a purge lumen, an electrical cable, and a differential pressure measurement cable. The catheter shaft has transversal marks: • The transversal marks at 1 cm intervals aid in proper positioning.

Repositioning unit

The repositioning unit consists of a sheath and an anticontamination sleeve with an anchoring ring. • The 11 Fr sheath (14 Fr outer diameter) with hemostatic valve is located on the catheter shaft and allows repositioning of the catheter. • The anchoring ring of the anticontamination sleeve secures the sheath to the catheter; turning in the counterclockwise direction enables movement of the catheter and turning in the clockwise direction disables movement.

Blue Impella® plug

The blue Impella® plug has a clear sidearm and contains memory that retains operating parameters in case the patient needs to be transferred to another controller. The plug connects the Impella RP® Catheter to the Automated Impella® Controller through a connector cable.

Clear sidearm

The clear sidearm is attached to the purge cassette tubing. It leads to the infusion filter, the pressure reservoir, and the check valve.

Infusion filter

The infusion filter prevents bacterial contamination and prevents air from entering the purge lumen.

Pressure reservoir

The pressure reservoir includes a flexible rubber diaphragm that provides additional filling volume by means of an expansion chamber during purge solution change.

Check valve

The yellow check valve ensures that purge fluid does not flow in the reverse direction when the purge solution is exchanged.

DIFFERENTIAL PRESSURE SENSOR The Impella RP® Catheter has an electronic differential pressure sensor located at the proximal end of the cannula. The purpose of the pressure sensor is to generate the placement signal used to calculate the flow generated by the Impella RP® Catheter. The pressure sensor is a flexible membrane integrated into the cannula. One side of the sensor is exposed to the blood pressure on the outside of the inlet area and the other side is exposed to the pressure of the blood inside of the cannula. The sensor generates an electrical signal proportional to the difference between the pressure outside the inlet area and the pressure inside the cannula. This signal is displayed on the Automated Impella® Controller as the placement signal.

3.4

Instructions for Use & Clinical Reference Manual (US)

• The controller provides an interface for monitoring and controlling the function of the Impella RP® Catheter • The controller provides a fluid purge to the Impella RP® Catheter • The controller provides backup power when the Impella RP® System is operated away from AC power

Automated Impella® Controller Battery Power The controller can operate on its internal lithium-ion (Li-Ion) battery for at least 60 minutes when fully charged.

The controller weighs 26 lbs (11.8 kg) and can operate on its internal battery for at least 60 minutes when fully charged. Using the controller, the Impella RP® System can be used by trained healthcare professionals in healthcare facilities and during medical transport (ie, ambulance, helicopter, or fixed-winged aircraft) environments. Automated Impella® Controller operation is described in detail in section 4 of this manual.

2016-07-22 10:09

AIC SN: IC4186 AIC V5.1

Figure 3.4 Automated Impella® Controller – Front View

Impella RP® with the Automated Impella® Controller

3.5

THE IMPELLA RP® CATHETER AND AUTOMATED IMPELLA® CONTROLLER

The Automated Impella® Controller (see Figure 3.4) provides three vital functions to the operation of the Impella RP® Catheter:

3

AUTOMATED IMPELLA® CONTROLLER