ABIOMED Impella Controller Users Manual

®

Impella

Circulatory Support System

Controller

With Impella® 2.5

INSTRUCTIONS

FOR USE

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.

©2009 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.

Impella® and RECOVER are trademarks of ABIOMED Europe GmbH, a wholly owned subsidiary of ABIOMED, Inc.,
and are registered in the U.S.A. and certain foreign countries.

is a trademark of ABIOMED, Inc.

IMPELLA® CONTROLLER

®

WITH IMPELLA

2.5

CIRCULATORY SUPPORT SYSTEM

INSTRUCTIONS FOR USE

Rx Only

Abiomed, Inc.

22 Cherry Hill Drive

Danvers, MA 01923

978-777-5410 (voice)

978-777-8411 (fax)

[e-mail] (email)

Abiomed Europe GmbH

Neuenhofer Weg 3
52074 Aachen, Germany
[phone] (voice)
[phone] (fax)

[e-mail] (email)

www.abiomed.com

24-Hour Emergency Hotlines:

N. America 1-800-422-8666

Europe [phone]

September 2009

Document No. 0042-9000 Rev. A Draft 3

TABLE OF CONTENTS

INTRODUCTION

Introduction ............................................................................................. I

1 WARNINGS AND CAUTIONS

Warnings ................................................................................................. 1.1

Cautions .................................................................................................. 1.3

2 INDICATIONS, CONTRAINDICATIONS,

AND POTENTIAL ADVERSE EVENTS

Indications ............................................................................................... 2.1

Contraindications ..................................................................................... 2.2

Potential Adverse Events .......................................................................... 2.3

3 THE IMPELL A® 2.5

AND IMPELLA® CONTROLLER

Overview ................................................................................................. 3.1

Impella® 2.5 Catheter .............................................................................. 3.3

Impella® Controller .................................................................................. 3.5

Purge Cassette ......................................................................................... 3.6

Accessories ..............................................................................................3.8

4 USING THE IMPELLA® CONTROLLER

Overview ................................................................................................. 4.1

Impella® Controller Features .................................................................... 4.2

Impella® Controller Home Screen Display .................................................4.4

Impella® Controller Waveform Screen Display .......................................... 4.7

5 USING THE IMPELLA® CONTROLLER

WITH THE IMPELLA® 2.5

Startup ..................................................................................................... 5.1

Case Start ................................................................................................ 5.3

Inserting the Impella® 2.5 Catheter .......................................................... 5.8

Positioning and Starting the Impella® 2.5 Catheter .................................. 5.11

Use of the Repositioning Introducer

and the 13 Fr Peel-Away Introducer .........................................................5.14

Purger Procedures .................................................................................... 5.15

Troubleshooting the Purge System ........................................................... 5.18

Patient Weaning ......................................................................................5.19

How to Change to Backup Controller .......................................................6.15

Emergency Shutdown Procedure .............................................................. 6.15

7 CLEANING, STOR AGE, DISPOSAL,

AND RETURNS

Cleaning .................................................................................................. 7.1

Storing the Impella® Controller ................................................................ 7.1

Disposing of the Pump and Accessories (EU) ............................................ 7.1

Returning an Impella® Pump to Abiomed (US).......................................... 7.1

8 TERMINOLOGY, ABBREVIATIONS,

AND SYMBOLS

Terminology, Abbreviations, and Symbols ................................................ 8.1

9 SYSTEM SPECIFICATIONS

Impella® Controller Mechanical ................................................................ 9.1

Impella® Controller Electrical ................................................................... 9.1

Equipment Design .................................................................................... 9.2

Equipment Classifications ........................................................................ 9.2

Federal Communications Commission (FCC) Notice .................................. 9.3

Electromagnetic Compatibility ................................................................. 9.3

Patient Environment ................................................................................. 9.6

White Connector Cable ............................................................................ 9.8

Pump Parameters ..................................................................................... 9.8

Impella® 2.5 Dimensions ..........................................................................9.9

10 IMPELLA® CONTROLLER ALARMS

Impella® Controller Alarms ....................................................................... 10.1

APPENDICES

Appendix A: Impella® System Limited Service Warranty ..........................A.1

Appendix B: Technical Safety Inspections, Maintenance, and Repair ....... B.1

Appendix C: Abiomed-Approved Guidewires .......................................... C.1

Appendix D: Impella® Controller Menu Structure .................................... D.1

6 PATIENT MANAGEMENT TOPICS

Patient Management Overview ................................................................ 6.1

General Patient Care Considerations ....................................................... 6.1

Transport Within the Hospital .................................................................. 6.1

Right Heart Failure ................................................................................... 6.2

Cardiopulmonary Resuscitation (CPR) ...................................................... 6.2

Defibrillation ............................................................................................ 6.3

ECG Interference ...................................................................................... 6.3

Latex ........................................................................................................ 6.3

Positioning and Placement Devices ..........................................................6.3

Suction .................................................................................................... 6.4

Hemolysis ................................................................................................ 6.4

Understanding and Managing Impella® Position Alarms .......................... 6.6

Repositioning Guide ................................................................................. 6.10

Data Snap Shot Recording ........................................................................ 6.13

Infusion History ........................................................................................ 6.13

Operating the Impella® 2.5 Without Heparin in

the Purge Solution ................................................................................... 6.14

Guidelines for Explant .............................................................................. 6.14

TABLE OF CONTENTS

FIGURES

Figure 3.1 Impella® 2.5 ............................................................................... 3.1

Figure 3.2 Impella® Controller, Impella 2.5, and Accessories ....................... 3.2

Figure 3.3 Impella® 2.5 Catheter ................................................................ 3.3

Figure 3.4 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 0.018 in/260 cm Placement Guidewire ....................................... 3.8

Figure 3.9 20% Dextrose in Water .............................................................. 3.9

Figure 3.10 Impella® Controller Cart ........................................................... 3.9

Figure 4.1 Impella® Controller Features – Front and Side Views .................. 4.2

Figure 4.2 Impella® Controller Home Screen Display ...................................4.4

Figure 4.3 Waveform Screen Display (Waveform TBD) ................................. 4.7

Figure 5.1 Impella® Controller Power Switch ...............................................5.1

Figure 5.2 Impella® Controller Startup Screen ............................................. 5.2

Figure 5.3 Inserting Purge Cassette into Impella® Controller ....................... 5.4

Figure 5.4 Default Values for Purge Fluid ....................................................5.5

Figure 5.5 Snapping Plastic Hook to Connector Cable ................................. 5.6

Figure 5.6 Squeezing the White Flush Valve to Prime

the Impella® Catheter Pressure Lumen ..................................... 5.7

Figure 5.7 Inserting the 13 Fr Peel-Away Introducer .................................... 5.8

Figure 5.8 Inserting the 6 Fr Diagnostic Catheter ........................................ 5.9

Figure 5.9 Loading the Catheter on the Guidewire ...................................... 5.10

Figure 5.10 Exiting of the Placement Guidewire from the Catheter .............. 5.10

Figure 5.11 Inserting the Impella® 2.5 Catheter .......................................... 5.10

Figure 5.12 Ventricular Waveform on Placement Signal Screen .................... 5.11

Figure 5.13 Aortic Waveform on Placement Signal Screen ........................... 5.12

Figure 5.14 Selecting Target Flow ............................................................... 5.12

Figure 5.15 Confirming Placement on the Placement Signal Screen ............. 5.13

Figure 5.16 Removing the 13 Fr Peel-Away Introducer ................................ 5.14

Figure 6.1 Correct Catheter Position ........................................................... 6.6

Figure 6.2 Catheter Fully in Ventricle .......................................................... 6.7

Figure 6.3 Impella® Completely in the Aorta or Inlet and Outlet Area

in Ventricle and Pressure Port in Aorta ..................................... 6.8

Figure 6.4 Pump Position Unknown Due to Low Pulsatility

[Waveform TBD; Motor Current y-axis scale to be revised] ....... 6.9

Figure 6.5 Impella® Outlet Area on or near Aortic Valve ............................. 6.10

Figure 6.6 First Repositioning Guide Screen ................................................6.11

Figure 6.7 Second Repositioning Guide Screen ........................................... 6.11

Figure 6.8 Third Repositioning Guide Screen ............................................... 6.12

Figure 6.9 Exit Repositioning Guide Screen ................................................. 6.12

Figure 6.10 Infusion History Screen ............................................................. 6.13

Figure 9.1 Impella® Controller Patient Environment..................................... 9.7

Figure 9.2 Impella® 2.5 Dimensions ............................................................ 9.9

Figure B.1 Inspection Sticker Showing Inspection Required in May 2010 ..... B.1

TABLES

Table 3.1 Impella

Table 3.2 Purge Cassette Components ....................................................3.7

Table 3.3 Impella® 2.5 and Impella® Controller Accessories .................... 3.8

Table 4.1 Impella® Controller Features ....................................................4.3

Table 4.2 Impella® Controller Display Elements .......................................4.4

Table 6.1 Guide for Managing Hemolysis in Various Circumstances ......... 6.5

Table 8.1 Terminology and Abbreviations ................................................ 8.1

Table 8.2 Symbols ................................................................................... 8.1

Table 10.1 Audible Alarm and Notification Indicators................................ 10.1

Table 10.2 Critical (Red) Alarms ................................................................ 10.3

Table 10.3 Warning (Yellow) Alarms.......................................................... 10.5

Table 10.4 Advisor y (White) Notifications ................................................. 10.6

®

2.5 Catheter Components .......................................... 3.3

INTRODUCTION

PURPOSE OF MANUAL

This Instructions for Use manual is designed for healthcare professionals. It contains clinical and

®

technical considerations to guide healthcare professionals in their use of the Impella

®

with the Impella

2.5 Catheter. The Impella® 2.5 and Impella® Controller perform life-sustaining

functions. Use of these components requires a thorough understanding of and adherence to

®

these instructions for use. The Impella

Controller with the Impella® 2.5 may only be used for its

intended purpose.

MANUAL OVERVIEW

®

This manual provides instructions for use of the Impella

Controller with the Impella® 2.5. The

following summarizes the contents of each section:

• Section 1: Warnings and Cautions discusses the warnings and cautions pertaining

®

to the use of the Impella

Controller with the Impella® 2.5.

• Section 2: Indications, Contraindications, and Potential Adverse Events

®

discusses indications for use of the Impella

Controller with the Impella® 2.5 and potential

adverse events.

®

• Section 3: The Impella

2.5 and Impella® Controller provides an overview of the

blood pump and controller and describes the major components and features of each.

®

• Section 4: Using the Impella

®

types on the Impella

Controller.

• Section 5: Using the Impella

Controller describes the controls and various screen

®

Controller with the Impella® 2.5 provides the

procedures for using the controller and blood pump.

Controller

INTRODUCTION

• Section 6: Patient Management Topics provides key information on various topics

®

related to management of patients with the Impella

Controller and Impella® 2.5.

• Section 7: Cleaning, Storage, Disposal, and Returns provides instructions on
cleaning and storing the components, as well as disposing of components and returning
components to Abiomed.

• Section 8: Terminology, Abbreviations, and Symbols provides definitions for key
terms that appear in the manual as well as descriptions of the abbreviations and symbols

®

that appear on Impella

Controller and Impella® 2.5 components and packaging.

• Section 9: System Specifications lists technical information pertaining to the

®

Impella

• Section 10: Impella

Controller and Impella® 2.5.

®

Controller Alarms provides a listing of Impella® Controller

alarms and notifications as well as information on what to do to resolve them.

• Appendices at the end of the manual provide supplemental information about topics

®

including the Impella
and repair; Abiomed-approved guidewires; and the Impella

Impella® Controller with Impella® 2.5

Limited Service Warranty; technical safety inspection, maintenance

®

Controller menu structure.

I

1 WARNINGS AND CAUTIONS

WARNINGS ...................................................................................................1.1

CAUTIONS ....................................................................................................1.2

WARNINGS

1 WARNINGS AND CAUTIONS

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

Fluoroscopy is required to guide placement of the Impella® 2.5. The small
placement guidewire must be reliably observed at all times.

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.

Retrograde flow will occur across the aortic valve if the Impella® 2.5 is set at a flow
rate of 0 L/min.

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.

Warnings

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

appears before

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.

If at any time during the course of support with the Impella®, the Impella®
Controller alarms “Impella Failure: Sudden Purge Pressure Drop,” follow the
instructions presented in Section 5 of this manual.

Do NOT subject a patient who has been implanted with an Impella® 2.5 to
magnetic resonance imaging (MRI). The strong magnetic energy produced by an
MRI machine may cause the Impella® System components to stop working, and
result in injuries to the patient. An MRI may also damage the electronics of the
Impella® System.

During defibrillation, do NOT touch the pump, cables, or Impella® Controller.

Power the Impella® Controller using its internal battery if the integrity of the
protective earth conductor is questionable.

Impella® Controller with Impella® 2.5

1.1

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 the accompanying documents.

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.

1.2

1.2

Instructions for Use

CAUTIONS

1 WARNINGS AND CAUTIONS

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.

Do NOT touch the inlet or outlet areas of the catheter and avoid manual
compression of the inlet cannula assembly while placing the device.

Patients with aortic stenosis or other abnormal aortic valve performance may be
compromised by the use of the Impella® 2.5. 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 4 minutes. The Impella® 2.5 Catheter may be damaged if replacement takes
longer than 4 minutes.

Cautions

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

appears before

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 10 hours prior to system operation. 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.

Impella® Controller with Impella® 2.5

1.3

The use of high-frequency surgical devices may cause temporary interference to the
sensor signals. If continuous interference persists, the following warning message
appears on the display screen: “Sensor Value not Reliable.” Please acknowledge
this message. There is no reason to discontinue use of the pump.

Have a backup Impella® Controller available in the unlikely event of controller
failure.

Do NOT use the bed mount as a handle.

1.4

Instructions for Use

2 INDICATIONS, CONTRAINDICATIONS,

AND POTENTIAL ADVERSE EVENTS

INDICATIONS ................................................................................................2.1

Indications for Use in the United States ............................................................ 2.1

Intended Use in the European Union and Canada ............................................ 2.1

CONTRAINDICATIONS ................................................................................. 2.2

Contraindications in the United States .............................................................2.2

Contraindications in the European Union .........................................................2.2

Contraindications in Canada ............................................................................2.2

POTENTIAL ADVERSE EVENTS ..................................................................... 2.3

Potential Adverse Events (US) ..........................................................................2.3

Possible Complications (EU and Canada) .........................................................2.3

INDICATIONS

INDICATIONS FOR USE IN THE UNITED STATES

®

The Impella
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
useful in determining intravascular pressure.

2.5 Circulatory Support System is intended for partial circulatory support using an

®

2.5 Circulatory Support System also provides pressure measurements which are

2

INDICATIONS, CONTRAINDICATIONS, AND POTENTIAL ADVERSE EVENTS

Investigational Device
Exemption (IDE) Clinical
Trials

INTENDED USE IN THE EUROPEAN UNION AND CANADA

®

The Impella

2.5 (intracardiac pump for supporting the left ventricle) is intended for clinical
use in cardiology and in cardiac surgery for up to 5 days for the following indications, as well
as others:

®

• The Impella

2.5 is a circulatory support system for patients with reduced left ventricular
function, eg, post-cardiotomy, low output syndrome, cardiogenic shock after acute
myocardial infarction, or for myocardial protection after acute myocardial infarction

®

• The Impella

2.5 may also be used as a cardiovascular support system during coronary
bypass surgery on the beating heart, particularly in patients with limited preoperative
ejection fraction with a high risk of postoperative low output syndrome

• Support during high risk percutaneous coronary intervention (PCI)

• Post PCI

In addition to the indications
for use outlined in this IFU,
the Impella
Support system is being
evaluated in various FDA
approved clinical trials for
additional indications and
patient populations. Refer
to the study protocols
for additional indications,
contraindications, and
inclusion and exclusion criteria
if the device is being used
under a clinical trial protocol.

®

2.5 Circulatory

Impella® Controller with Impella® 2.5

2.1

CONTRAINDICATIONS

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

CONTRAINDICATIONS IN THE UNITED STATES

• Mechanical aortic valve or heart constrictive device.

• Aortic valve stenosis/calcication (graded as ≥ +2 equivalent to an orice area of 1.5 cm

or less).

• Moderate to severe aortic insufciency (echocardiographic assessment of aortic
insufciency graded as ≥ +2).

®

• Severe peripheral arterial obstructive disease that would preclude Impella

placement.

CONTRAINDICATIONS IN THE EUROPEAN UNION

2.5 device

2

• Mechanical aortic valves, severe aortic valvular stenosis or valvular regurgitation

• Hematological disorder causing fragility of the blood cells or hemolysis

• Hypertrophic obstructive cardiomyopathy (HOCM)

• Aneurysm or necrotomy or severe anomaly of the ascending aorta and/or the aortic arch

• Mural thrombus in the left ventricle

• Ventricular septal defect (VSD) after myocardial infarction

• Anatomic conditions precluding insertion of the pump

• Other illnesses or therapy requirements precluding use of the pump

• Severe peripheral arterial occlusion disease (PAOD) is a relative contraindication

CONTRAINDICATIONS IN CANADA

• Prosthetic aortic valves, severe aortic valvular stenosis or valvular regurgitation

• Hematological disorder causing fragility of the blood cells or hemolysis

• Hypertrophic obstructive cardiomyopathy (HOCM)

• Aneurysm or necrotomy or severe anomaly of the ascending aorta and/or the aortic arch

2.2

• Mural thrombus in the left ventricle

• Ventricular septal defect (VSD) after myocardial infarction

• Anatomic conditions precluding insertion of the pump

• Other illnesses or therapy requirements precluding use of the pump

• Peripheral arterial occlusion disease (PAOD)

Instructions for Use

POTENTIAL ADVERSE EVENTS

POTENTIAL ADVERSE EVENTS (US)

2

INDICATIONS, CONTRAINDICATIONS, AND POTENTIAL ADVERSE EVENTS

• Death

• Aortic insufciency

• Arrhythmia

• Bleeding

• Cardiogenic shock

• Hemolysis

• Insertion site infection

• Perforation

• Respiratory dysfunction

• Thrombocytopenia

• Transient ischemic attack (TIA)

• Ventricular brillation

POSSIBLE COMPLICATIONS (EU AND CANADA)

There are risks of complications with every procedure using a blood pump. These include
among others:

• Cerebral vascular accident (CVA) / Stroke

• Aortic valve injury

• Atrial brillation

• Cardiac tamponade

• Device malfunction

• Hepatic failure

• Myocardial infarction

• Renal failure

• Sepsis

• Thrombotic vascular (non-CNS) complication

• Vascular injury

• Ventricular tachycardia

• Hemolysis

• Bleeding

• Immune reaction

• Embolism, thrombosis

• Vascular injury through to

angionecrotomy

• Positioning problems

• Infection and septicemia

• Dislocation of the pump

• Cardiovalvular injuries due to extreme

movement of the suction cannula in
relation to the cardiac valve or as a result of
attachment by suction of the pump to the
valve system following incorrect positioning

• Endocardiac injuries as a result of

attachment of the pump due to suction

• Pump failure, loss of pump components

following a defect

• Patient dependency on the pump after use

for support

Impella® Controller with Impella® 2.5

2.3

3 THE IMPELLA® 2.5

AND IMPELLA® CONTROLLER

OVERVIEW .................................................................................................... 3.1

IMPELLA

IMPELLA

PURGE CASSETTE .........................................................................................3.6

ACCESSORIES ...............................................................................................3.8

®

2.5 CATHETER ............................................................................ 3.3

®

CONTROLLER ...............................................................................3.5

OVERVIEW

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

3 THE IMPELLA

®

2.5 AND IMPELLA

®

CONTROLLER

Figure 3.1 Impella® 2.5

When properly positioned, the pump 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 pump on the display

®

screen of the Impella

This section describes the components of the Impella

Controller.

®

2.5, the Impella® Controller, and the

accessory components.

Impella® Controller with Impella® 2.5

3.1

Figure 3.2 illustrates how the Impella® Controller connects to the Impella® 2.5 and accessory
components.

Figure 3.2 Impella® Controller, Impella 2.5, and Accessories

3.2

Instructions for Use

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 3.3 illustrates the

®

Impella
check valve on the other end.

2.5 Catheter. Table 3.1 describes each component from the pigtail at one end to the

3 THE IMPELLA

®

2.5 AND IMPELLA

®

CONTROLLER

Figure 3.3 Impella® 2.5 Catheter

®

Table 3.1 Impella

2.5 Catheter Components

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.

Cannula The 12 Fr cannula has a spiral-shaped reinforced body that is shaped in

a 45-degree angle.

Inlet area The inlet area, where the blood enters the cannula, is located at the

distal tip of the cannula.

Outlet area The proximal end of the cannula is attached to the outlet area where

the blood exits the cannula.

Impella® Controller with Impella® 2.5

3.3

Table 3.1 Impella

®

2.5 Catheter Components (cont’d)

Component Description

Motor housing The motor housing is 12 Fr in diameter and consists of a completely

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 plug. The lumen of the catheter shaft contains a purge lumen,
a pressure measurement lumen, and a pump monitoring cable.
The catheter shaft has longitudinal and transversal marks:

• The longitudinal marks along the inner radius of the cannula show

the position of the curved, flexible cannula.

• The transversal marks at 1 cm intervals aid in proper positioning.

Repositioning unit The repositioning unit consists of an introducer and an

anticontamination sleeve with an anchoring ring.

• The introducer (with hemostatic valve) is graduated from 11 Fr to
15 Fr. It is located on the catheter shaft and allows repositioning of
the catheter.

• The anchoring ring of the anticontamination sleeve secures the

catheter sheath to the introducer.

Plug The plug at the proximal end of the catheter connects the catheter to

the Impella® Controller through a connector cable. 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 purge line. 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 catheter.

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.

3.4

Instructions for Use

IMPELLA® CONTROLLER

3 THE IMPELLA

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

®

Impella

2.5:

• The controller provides an interface for monitoring and controlling the function of the

Impella 2.5

• The controller provides a uid purge to the Impella 2.5 motor

• The controller provides backup power when the controller 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.

Impella® Controller
Battery Power

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

®

2.5 AND IMPELLA

®

CONTROLLER

Figure 3.4 Impella® Controller – Front View

Impella® Controller with Impella® 2.5

3.5

PURGE CASSETTE

Do not use saline in the purge system.

The purge cassette delivers rinsing fluid to the Impella® pump. The purge fluid (typically 20%
dextrose solution plus heparin 50 IU/mL) flows from the purge cassette through the catheter to
the microaxial blood pump to prevent blood from entering the pump motor. Figure 3.5 illustrates
the purge cassette and related components. Table 3.2 describes each component.

3.6

Figure 3.5 Purge Cassette

Instructions for Use