Impella 2.5 Instructions for Use & Clinical Reference Manual Rev B Sept 2010

IMPORTANT NOTICE: Read this entire manual before using the Impella® Controller and Impella® 2.5 Circulatory Support System (Impella® 2.5 System). The Impella® 2.5 System is to be used only in accordance with this manual. This manual is only applicable to Impella® systems using the Impella® Controller. Information contained in this document is subject to change without notice. ©2010 Abiomed®, Inc. All rights reserved. The ABIOMED logo and ABIOMED are trademarks of Abiomed, Inc. and are registered in the U.S.A. and certain foreign countries. Recovering hearts. Saving lives. is a trademark of Abiomed, Inc. Impella® is a trademark of Abiomed Europe GmbH, a wholly owned subsidiary of Abiomed, Inc., and is registered in the U.S.A. and certain foreign countries.

Impella® 2.5 With The 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 September 2010 Document No. 0042-9000 Rev. B

Table of Contents INTRODUCTION Introduction... I 1 Warnings and Cautions Warnings... 1.1 Cautions... 1.2 2 Indications, Contraindications, and Potential Adverse Events Indications (United States)... 2.1 Contraindications (United States)... 2.1 Potential Adverse Events (United States)... 2.2 3 The Impella® 2.5 Catheter and Impella® Controller Overview... 3.1 Impella® 2.5 Catheter... 3.4 Impella® Controller... 3.6 Purge Cassette... 3.7 Accessories... 3.9 4 Using the Impella® Controller Overview... 4.1 Impella® Controller Features... 4.2 Impella® Controller Home Screen... 4.6 Selecting Performance Level... 4.9 Impella® Controller Waveform Screen... 4.10 Impella® Controller Infusion Screen... 4.12 Mobile Operation... 4.13 5 Using the Impella® Controller With the Impella® 2.5 Catheter Startup... 5.1 Case Start... 5.4 Inserting the Impella® 2.5 Catheter... 5.11 Positioning and Starting the Impella® 2.5 Catheter... 5.15 Use of the Repositioning Sheath and the 13 Fr Peel-Away Introducer... 5.17 Transfer to Standard Configuration... 5.18 Purge Cassette Procedures... 5.19 Troubleshooting the Purge System... 5.23 Patient Weaning... 5.25 6 Patient Management Topics Patient Management Overview... 6.1 General Patient Care Considerations . ... 6.1 Transport Within the Hospital... 6.1 Transport Between Hospitals... 6.2 Right Heart Failure... 6.3 ECG Interference... 6.3 Latex... 6.3 Use of Echocardiography for Positioning of the Impella® 2.5 Catheter... 6.4 Understanding and Managing Impella® 2.5 Catheter Position Alarms... 6.11 Suction... 6.17 Hemolysis... 6.17 Operating the Impella® 2.5 Catheter without Heparin in the Purge Solution... 6.19 Repositioning Guide... 6.19 Placement Signal Lumen... 6.22 Data Snap Shot Recording... 6.23 Infusion History... 6.24 How to Change to a Backup Controller... 6.25 Emergency Shutdown Procedure... 6.25

7 Impella® Controller Alarms Alarms Overview... 7.1 Alarm Message Summary... 7.3 8 General System Information Terminology, Abbreviations, and Symbols... 8.1 Impella® Controller Mechanical Specifications... 8.3 Impella® Controller Electrical Specifications... 8.3 Equipment Design... 8.4 Equipment Classifications... 8.4 Federal Communications Commission (FCC) Notice... 8.5 Electromagnetic Compatibility... 8.5 Alarm Delay Information... 8.9 Patient Environment... 8.9 White Connector Cable... 8.10 Impella® 2.5 Catheter Parameters... 8.10 Impella® 2.5 Catheter Dimensions... 8.11 Anatomic Considerations... 8.12 Cleaning... 8.12 Storing the Impella® Controller... 8.13 Returning an Impella® 2.5 Catheter to Abiomed (United States)... 8.13 Appendices Appendix A: Impella® System Limited Service Warranty (United States)... A.1 Appendix B: Technical Safety Inspections, Maintenance, and Repair... B.1 Appendix C: Abiomed-Approved Guidewires and Introducers... C.1 Appendix D: Impella® Controller Menu Structure... D.1

Table of Contents Figures Figure 3.1 Impella® 2.5 Catheter in the Heart... 3.1 Figure 3.2 Set-up Configuration of the Impella® Controller, Impella® 2.5 Catheter, and Accessories... 3.3 Figure 3.3 Standard Configuration of the Impella® Controller, Impella® 2.5 Catheter, and Accessories... 3.3 Figure 3.4 Impella® 2.5 Catheter... 3.4 Figure 3.5 Impella® Controller – Front View... 3.6 Figure 3.6 Purge Cassette... 3.7 Figure 3.7 White Connector Cable... 3.9 Figure 3.8 Introducer Kit... 3.9 Figure 3.9 0.018 inch, 260 cm Placement Guidewire... 3.9 Figure 3.10 Dextrose Solution... 3.10 Figure 3.11 Impella® Controller Cart... 3.10 Figure 4.1 Impella® Controller Features – Front View... 4.2 Figure 4.2 Impella® Controller Features – Side Views... 4.4 Figure 4.3 Impella® Controller Home Screen... 4.6 Figure 4.4 Waveform Screen... 4.10 Figure 4.5 Infusion Screen... 4.12 Figure 5.1 Impella® Controller Power Switch... 5.2 Figure 5.2 Impella® Controller Startup Screen... 5.3 Figure 5.3 Initial Case Start Screen... 5.4 Figure 5.4 Inserting Purge Cassette into Impella® Controller... 5.5 Figure 5.5 Inserting the Catheter Plug into the Connector Cable... 5.6 Figure 5.6 Snapping Plastic Clip to Connector Cable... 5.6 Figure 5.7 Priming the Impella Purge Lumen... 5.7 Figure 5.8 Connecting the Luer(s) to the Impella® 2.5 Catheter... 5.7 Figure 5.9 Priming the Placement Signal Lumen... 5.8 Figure 5.10 Squeezing the White Flush Valve to Prime the Placement . Signal Lumen... 5.8 Figure 5.11 Entering Purge Fluid Information... 5.9 Figure 5.12 Connecting the Purge Tubing to the Connector Cable... 5.10 Figure 5.13 Set-up Configuration of the Impella® 2.5 System... 5.10 Figure 5.14 Inserting the 13 Fr Peel-Away Introducer... 5.11 Figure 5.15 Inserting the 6 Fr Diagnostic Catheter... 5.12 Figure 5.16 Loading the Catheter on the Guidewire... 5.13 Figure 5.17 Aligning the Placement Guidewire... 5.13 Figure 5.18 Inserting the Impella® 2.5 Catheter... 5.14 Figure 5.19 Aortic Waveform on Placement Signal Screen... 5.14 Figure 5.20 Selecting P-Level... 5.15 Figure 5.21 Confirming Placement on the Placement Signal Screen... 5.16 Figure 5.22 Ventricular Waveform on Placement Signal Screen... 5.16 Figure 5.23 Removing the 13 Fr Peel-Away Introducer... 5.17 Figure 5.24 Standard Configuration for Impella® 2.5 System after Transfer from the Set-up Configuration... 5.19 Figure 5.25 Disconnecting the Y Connector from the Purge Cassette . Tubing... 5.20 Figure 6.1 Labeled TEE and TTE Images of the Impella® 2.5 Catheter Position... 6.5 Figure 6.2 Transesophageal Echocardiographic (TEE) Illustrations of . Impella® 2.5 Catheter Position... 6.8 Figure 6.3 Transthoracic Echocardiographic (TTE) Illustrations of . Impella® 2.5 Catheter Position... 6.9 Figure 6.4 Correct and Incorrect Impella® 2.5 Catheter Position (Color Doppler TTE)... 6.10 Figure 6.5 Correct Impella® 2.5 Catheter Position... 6.12 Figure 6.6 Impella® 2.5 Catheter Fully in Ventricle... 6.13 Figure 6.7 Impella® 2.5 Catheter Completely in the Aorta or Inlet and Outlet Areas in Ventricle and Open Pressure Area in Aorta... 6.14 Figure 6.8 Impella® 2.5 Catheter Position Unknown... 6.15 Figure 6.9 Impella® 2.5 Catheter Outlet Area on or near Aortic Valve... 6.16

Figure 6.10 Figure 6.11 Figure 6.12 Figure 6.13 Figure 6.14 Figure 6.15 Figure 8.1 Figure 8.2 Figure B.1

Tables Table 3.1 Table 3.2 Table 3.3 Table 3.4 Table 4.1 Table 4.2 Table 4.3 Table 4.4 Table 6.1 Table 6.2 Table 7.1 Table 7.2 Table C.1 Table C.2

First Repositioning Guide Screen... 6.20 Second Repositioning Guide Screen... 6.20 Third Repositioning Guide Screen... 6.21 Exit Repositioning Guide Screen... 6.21 Displacing Air During Flush Solution Change Out Procedure... 6.23 Infusion History Screen... 6.24 Impella® Controller Patient Environment... 8.9 Impella® 2.5 Catheter Dimensions... 8.11 Inspection Sticker Showing Inspection Required in May 2012... B.1

Impella® 2.5 Set-up and Insertion Kit Components... 3.2 Impella® 2.5 Catheter Components... 3.4 Purge Cassette Components... 3.8 Impella® 2.5 Catheter and Impella® Controller Accessories... 3.9 Impella® Controller Front View Features... 4.3 Impella® Controller Side View Features... 4.5 Impella® Controller Display Elements... 4.6 Performance Level Flow Rates... 4.9 Guide for Managing Hemolysis in Various Circumstances... 6.18 Recommended Standards for Maintenance of the . Placement Signal... 6.22 Alarm Levels... 7.1 Impella® Controller Alarm Messages... 7.3 Alternative Guidewires... C.1 Alternative Introducer Sheaths... C.1

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® 2.5 Catheter with the Impella® Controller. The Impella® 2.5 System performs life-sustaining functions. To use the system you must understand and follow these instructions. The Impella® 2.5 System may be used only for its intended purpose. Manual Overview This manual provides instructions for use of the Impella® 2.5 Catheter with the Impella® Controller. The following summarizes the contents of each section of the manual. • Section 1: Warnings and Cautions discusses the warnings and cautions pertaining to the use of the Impella® 2.5 Catheter with the Impella® Controller. • Section 2: Indications, Contraindications, and Potential Adverse Events discusses indications for use of the Impella® 2.5 Catheter with the Impella® Controller, contraindications, and potential adverse events that may be associated with the use of the system. • Section 3: The Impella® 2.5 Catheter and Impella® Controller provides an overview of the system and describes its major components and features. • Section 4: Using the Impella® Controller describes the controls and various screen types on the Impella® Controller. • Section 5: Using the Impella® Controller with the Impella® 2.5 Catheter provides the procedures for using the Impella® 2.5 System. • Section 6: Patient Management Topics provides key information on various topics related to management of patients with the Impella® 2.5 Catheter and Impella® Controller. • Section 7: Impella® Controller Alarms provides a listing of Impella® Controller alarms as well as information on what to do to resolve them. • Section 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® 2.5 Catheter and Impella® Controller components and packaging, technical information pertaining to the Impella® 2.5 Catheter and Impella® Controller, and instructions on cleaning and storing system components as well as returning components to Abiomed. • Appendices at the end of the manual provide supplemental information about topics including the Impella® Limited Service Warranty; technical safety inspection, maintenance and repair; Abiomed-approved guidewires and introducers; and the Impella® Controller menu structure.

Impella® 2.5 Catheter with the Impella® Controller

I

1 Warnings and Cautions

Warnings... 1.1 Cautions...1.2

Warnings

Fluoroscopy is required to guide placement of the Impella® 2.5 Catheter. The small placement guidewire must be reliably observed at all times. Be sure that the stopcock on the peel-away introducer or 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 and outlet areas of the cannula assembly. The sterile components of the Impella® 2.5 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® 2.5 Catheter. It is a disposable device and is intended for single use only. Reuse, reprocessing, 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 across the aortic valve if the Impella® 2.5 Catheter is set at performance level P0. To prevent malfunction of the locking mechanism of the 13 Fr peel-away introducer, . do NOT hold the hemostatic valve while inserting into the artery. To prevent failure of the 13 Fr peel-away introducer, remove the 13 Fr peel-away introducer prior to transport when activated clotting time (ACT) is less than . 150 seconds. Do NOT use saline in the purge system. Do NOT use an Impella® 2.5 System if any part of the system is damaged. To prevent the risk of explosion, do NOT operate the Impella® 2.5 System near flammable anesthetics. If at any time during the course of support with the Impella® 2.5 Catheter, the Impella® Controller alarms “Purge Pressure Low” or “Purge System Open,” follow the instructions presented in section 5 of this manual. Do NOT subject a patient who has been implanted with an Impella® 2.5 Catheter to magnetic resonance imaging (MRI). The strong magnetic energy produced by an MRI machine may cause the Impella® 2.5 System components to stop working, and result in injuries to the patient. An MRI may also damage the electronics of the Impella® 2.5 System. During defibrillation, do NOT touch the Impella® 2.5 Catheter, cables, or Impella® Controller. Power the Impella® Controller using its internal battery if the integrity of the protective earth conductor is questionable.

Impella® 2.5 Catheter with the Impella® Controller

1.1

1 WARNINGS AND CAUTIONS

The Impella® 2.5 System is intended for use only by personnel trained in accordance with the Abiomed® Training Program.

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 Impella® Controller may be exposed to stronger electromagnetic disturbance than during in-hospital use. Strong electromagnetic disturbance may cause the 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® 2.5 Catheter flow and patient hemodynamics to confirm normal operation. The condition will resolve itself once the 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 Impella® Controller. The Impella® Controller uses RFID (radio frequency identification) to identify and communicate with the purge cassette. Other equipment may interfere with the Impella® Controller even if that other equipment complies with CISPR emission requirements. Infusion through the sideport of the introducer can be done only after all air is removed from the introducer. If performed, the infusion should be done for flushing purposes only and NOT for delivering therapy or monitoring blood pressure.

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

Handle with care. The Impella® 2.5 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. Patients with aortic stenosis or other abnormal aortic valve performance may be compromised by the use of the Impella® 2.5 Catheter. Patients with aortic valve disease should be observed for aortic insufficiency. Use only original accessories and replacement parts supplied by Abiomed. Do NOT use damaged or contaminated connector cables. To prevent device failure, do NOT start the Impella® 2.5 Catheter until the guidewire has been removed. Do NOT remove the Impella® 2.5 Catheter over the length of the guidewire. When replacing the purge cassette, the replacement process must be completed within 2 minutes. The Impella® 2.5 Catheter may be damaged if replacement takes longer than 2 minutes.

1.2

Instructions for Use & Clinical Reference Manual (US)

1 WARNINGS AND CAUTIONS

To prevent malfunction of the 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 Impella® Controller while it is operating. Do NOT kink or clamp the Impella® 2.5 Catheter or the 13 Fr peel-away introducer. 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 Impella® Controller will operate for at least 60 minutes after the batteries have been fully charged. Minimize exposure of Impella® 2.5 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® 2.5 System components may interfere with the operation of other devices. If interference occurs, increase the distance between the device and system components. Have a backup Impella® Controller available in the unlikely event of controller failure. Do NOT use the bed mount as a handle. Do NOT alter the Impella® 2.5 Introducer kit in any way. Aspiration and saline flushing of the Impella® 2.5 Introducer kit sheath, dilator, and valve should be performed to help minimize the potential for air embolism and clot formation. Indwelling introducer sheaths should be internally supported by a catheter, electrode, or dilator. Dilators, catheters, and pacing leads should be removed slowly from the sheath. Rapid removal may damage the valve, resulting in blood flow through the valve. Never advance the guidewire or sheath when resistance is met. Determine the cause of resistance using fluoroscopy and take remedial action. When injecting or aspirating through the sheath, use the sideport only.

Impella® 2.5 Catheter with the Impella® Controller

1.3

2 Indications, Contraindications, and Potential Adverse Events

Indications (United States)...2.1 Contraindications (United States)...2.1 Potential Adverse Events (United States)... 2.2

2

Indications (United States)

Indications, contraindications, and Potential Adverse Events

The Impella® 2.5 Circulatory Support System is intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The Impella® 2.5 Circulatory Support System also provides pressure measurements which are useful in determining intravascular pressure. The Impella® Controller is intended to be used by trained healthcare professionals in healthcare facilities and medical transport (ie, ambulance, helicopter, or fixed-wing aircraft) environments.

Contraindications (United States) Patients with aortic stenosis or other abnormal aortic valve performance may be compromised by the use of the Impella® 2.5 Catheter. Patients with aortic valve disease should be observed for aortic insufficiency.

• Mechanical aortic valve or heart constrictive device • Aortic valve stenosis/calcification (graded as ≥ +2 equivalent to an orifice area of . 1.5 cm2 or less) • Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥ +2) • Severe peripheral arterial obstructive disease that would preclude Impella® 2.5 device placement

Impella® 2.5 Catheter with the Impella® Controller

2.1

Potential Adverse Events (United States)

2.2

• Aortic insufficiency

• Insertion site infection

• Aortic valve injury

• Myocardial infarction

• Arrhythmia

• Perforation

• Atrial fibrillation

• Renal failure

• Bleeding

• Respiratory dysfunction

• Cardiogenic shock

• Sepsis

• Cardiac tamponade

• Thrombocytopenia

• Cerebral vascular accident (CVA) / Stroke

• Thrombotic vascular (non-CNS) complication

• Death

• Transient ischemic attack (TIA)

• Device malfunction

• Vascular injury

• Hemolysis

• Ventricular fibrillation

• Hepatic failure

• Ventricular tachycardia

Instructions for Use & Clinical Reference Manual (US)

3 The Impella® 2.5 Catheter and Impella® Controller

Overview...3.1 Reusable System Components...3.2 Single-use System Components...3.2 Impella® 2.5 Set-up and Insertion Kit...3.2 System Configurations...3.3 Impella® 2.5 Catheter...3.4 Impella® Controller...3.6 Purge Cassette...3.7 Accessories...3.9

Overview 3 The Impella® 2.5 Catheter and Impella® Controller

The Impella® 2.5 Catheter is an intravascular microaxial blood pump that supports a patient’s circulatory system. The Impella® 2.5 Catheter is inserted percutaneously through the femoral artery and into the left ventricle (see Figure 3.1).

Figure 3.1 Impella® 2.5 Catheter in the Heart

When properly positioned, the Impella® 2.5 Catheter delivers blood from the inlet area, which sits inside the left ventricle, through the cannula, to the outlet opening in the ascending aorta. Physicians and device operators monitor the correct positioning and functioning of the Impella® 2.5 Catheter on the display screen of the Impella® Controller. This section describes the components of the Impella® 2.5 Catheter and the Impella® Controller, as well as the accessory components.

Impella® 2.5 Catheter with the Impella® Controller

3.1

Reusable System Components The Impella® 2.5 System consists of the following reusable components: • Impella® Controller-provides the user interface, alarm indications, and portable battery • Impella® Controller cart-for easy transport of the Impella® Controller

Single-use System Components The Impella® 2.5 System also includes the following single-use components: • Impella® 2.5 Catheter • Purge cassette • Introducer kit • 0.018 inch, 260 cm placement guidewire • Connector cable Impella® 2.5 Set-up and Insertion Kit The components of the Impella® 2.5 System are packaged into a single box called the Impella® 2.5 Set-up and Insertion kit. Table 3.1 describes the contents of this kit. Table 3.1 Impella® 2.5 Set-up and Insertion Kit Components

The Impella® 2.5 Set-up and Insertion kit contains the following:

• Impella® 2.5 Catheter • 0.018 inch, 260 cm placement guidewire • Connector cable • Purge cassette • Introducer kit »» 13 Fr peel-away introducer »» 13 Fr dilator »» 18 G Seldinger needle »» 10 cc syringe »» 0.035 inch stiff access guidewire

3.2

Instructions for Use & Clinical Reference Manual (US)

System Configurations 3 The Impella® 2.5 Catheter and Impella® Controller

Figure 3.2 illustrates how the Impella® Controller connects to the Impella® 2.5 Catheter and accessory components in the initial set-up configuration. D20 D20

Dextrose Solution Impella® Controller

Impella® 2.5 Catheter

Purge Cassette

Connector Cable

Y-Connector

Figure 3.2 S  et-up Configuration of the Impella® Controller, Impella® 2.5 Catheter, and Accessories

Figure 3.3 illustrates the standard configuration of the Impella® 2.5 Catheter, Impella® Controller, and accessory components. D20

Dextrose Solution

Sodium Chloride (NaCl) Solution in Pressure Bag Impella® Controller

Impella® 2.5 Catheter

Purge Cassette

Connector Cable

Y-Connector

Figure 3.3 S  tandard Configuration of the Impella® Controller, Impella® 2.5 Catheter, and Accessories

Impella® 2.5 Catheter with the Impella® Controller

3.3

Impella® 2.5 Catheter The Impella® 2.5 Catheter is an intravascular microaxial blood pump that delivers up to 2.5 liters of blood per minute from the left ventricle into the aorta. Figure 3.4 illustrates the . Impella® 2.5 Catheter. Table 3.2 describes each component from the pigtail at one end to the check valve on the other end. Red Pressure Sidearm

Catheter Shaft

Red Impella Plug ®

Clear Sidearm Infusion Filter Pressure Reservoir Repositioning Unit

Pigtail Check Valve

Inlet Area Cannula Motor Housing Open Pressure Area Outlet Area

Figure 3.4 Impella® 2.5 Catheter

Table 3.2 Impella® 2.5 Catheter Components

3.4

Component

Description

Pigtail

The 6 Fr pigtail is attached to the cannula at the distal end of the inlet area. It assists with stabilizing the catheter in the correct position in the left ventricle.

Inlet area

The inlet area, located at the distal tip of the cannula, has four openings (windows) that allow blood to be drawn into the inlet and channeled through the cannula.

Cannula

The 12 Fr cannula has a spiral-shaped reinforced body that is shaped in a 45-degree angle. The cannula is made of nitinol and covered in polyurethane.

Instructions for Use & Clinical Reference Manual (US)

Table 3.2 Impella® 2.5 Catheter Components (continued)

Description

Outlet area

The proximal end of the cannula is attached to the outlet area where the blood exits the cannula.

Motor housing

The motor housing is 12 Fr in diameter and consists of an encapsulated motor.

Open pressure area

The open pressure area is an opening located between the motor housing and the distal end of the catheter shaft.

Catheter shaft

A 9 Fr catheter shaft is located between the motor housing and the red Impella® plug. The lumen of the catheter shaft contains a purge lumen, a pressure measurement lumen, and an electrical cable. The catheter shaft has longitudinal and transversal marks: • The longitudinal mark along the inner radius shows correct position of the 0.018 inch, 260 cm placement guidewire once backloaded on the Impella® 2.5 Catheter. • The transversal marks at 1 cm intervals with numbers every 5 cm aid in proper positioning.

Repositioning unit

The repositioning unit consists of a sheath and an anticontamination sleeve with an anchoring ring. • The sheath (with hemostatic valve) is graduated from 9 Fr to. 13 Fr. It 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.

Red Impella® plug

The red Impella® plug at the proximal end of the catheter connects the catheter to the Impella® Controller through a connector cable. It contains: • A pressure transducer that translates pressure for the pressure lumen proximal to the motor • Memory that retains operating parameters in case the patient needs to be transferred to another controller • The placement signal lumen that allows for pressure and waveform displays It has two sidearms: a red pressure sidearm and a clear sidearm.

Red pressure sidearm

The red pressure sidearm is attached to a standard pressure bag and is used to prime the line of the pressure measurement system.

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 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.

Impella® 2.5 Catheter with the Impella® Controller

Repositioning Sheath: Inner vs Outer Diameter The repositioning sheath has a graduated inner diameter of 9 Fr to 13 Fr. The outer diameter is graduated from 11 Fr to 15 Fr.

3.5

3 The Impella® 2.5 Catheter and Impella® Controller

Component

Impella® Controller 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 Impella® Controller (see Figure 3.5) provides three vital functions to the operation of the Impella® 2.5 Catheter: • The controller provides an interface for monitoring and controlling the function of the Impella® 2.5 Catheter • The controller provides a fluid purge to the Impella® 2.5 Catheter • The controller provides backup power when the Impella® 2.5 System is operated away from AC power The controller weighs 26 lbs (11.8 kg) and can operate on its internal battery for at least 60 minutes when fully charged. Impella® Controller operation is described in detail in section 4 of this manual.

Figure 3.5 Impella® Controller – Front View

3.6

Instructions for Use & Clinical Reference Manual (US)