ABIOMED Impella Controller Users Manual

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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.

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)

clinical@abiomed.com (email)

Abiomed Europe GmbH

Neuenhofer Weg 3 52074 Aachen, Germany +49 (241) 8860-0 (voice) +49 (241) 8860-111 (fax)

europe@abiomed.com (email)

www.abiomed.com

24-Hour Emergency Hotlines:

N. America 1-800-422-8666

Europe +49 (0) 1805 2246633

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.

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

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

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

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

• 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)

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

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

Table 3.2 Purge Cassette Components

Component Description

Purge cassette Contains the components for circulating the purge ﬂuid; maintains the

pressure barrier between the blood and the motor at the proper level

Purge pressure transmitter

Purge line Carries purge ﬂuid from the purge cassette to the Impella® pump

Yellow luer connector Connects the purge line to the pressure reservoir (yellow luer lock) on

Purge ﬂuid spike One end spikes the purge ﬂuid bag and the other end connects the

Spike connector Connects the purge cassette supply line to the purge ﬂuid spike

Supply line Carries ﬂuid from the purge ﬂuid bag to the purge cassette

Contains a membrane that transmits pressure to the controller based on the purge pressure in the purge line; a transducer in the controller measures the pressure so that it can be displayed on the screen

the Impella® pump

bag to the purge cassette supply line

3 THE IMPELLA

2.5 AND IMPELLA

CONTROLLER

Impella® Controller with Impella® 2.5

3.7

ACCESSORIES

Table 3.3 illustrates and describes the accessories used with the Impella® 2.5 and Impella® Controller.

Table 3.3 Impella® 2.5 and Impella® Controller Accessories

Component Description

The white connector cable connects the Impella®

2.5 Catheter to the Impella® Controller. The connector cable is attached to the Impella® pump in the original packaging.

• The socket at the black end of the cable

connects to the Impella® catheter plug.

• The white plug at the opposite end of the cable

is inserted into the blue pump plug on the front of the Impella® Controller.

Figure 3.6 White Connector Cable

The introducer kit is used to position the pump. It contains:

• 13 Fr peel-away introducer with hemostatic valve

• 13 Fr dilator

• 18 G Seldinger needle

• 10 cc syringe

• 0.035 in stiff guidewire

Guidewire Use

It is important to use only the guidewire supplied with the system or an Abiomedapproved alternative. Refer to Appendix C for more information about Abiomedapproved guidewires.

Figure 3.7 Introducer Kit

The 0.018 in/260 cm placement guidewire is used for the placement of the catheter. The guidewire has a radiopaque, shapable tip.

Figure 3.8 0.018 in/260 cm Placement Guidewire

3.8

Instructions for Use

Component Description

20% dextrose solution with 50 IU/mL of heparin is used as the purge ﬂuid. The purge cassette infuses the purge ﬂuid through the catheter.

Figure 3.9 20% Dextrose in Water

The Impella® Controller Cart holds the Impella® Controller. The cart has wheels for easy transport of the controller and a storage basket.

3 THE IMPELLA

2.5 AND IMPELLA

CONTROLLER

Figure 3.10 Impella® Controller Cart

Impella® Controller with Impella® 2.5

3.9

4 USING THE IMPELLA® CONTROLLER

OVERVIEW ....................................................................................................4.1

IMPELLA

CONTROLLER FEATURES............................................................. 4.2

CONTROLLER HOME SCREEN DISPLAY ...................................... 4.4

CONTROLLER WAVEFORM SCREEN DISPLAY ..............................4.7

Placement Signal Waveform.............................................................................4.7

Motor Current Waveform ................................................................................. 4.8

OVERVIEW

The Impella® Controller is the primary user control interface for the Impella® 2.5. It controls

the pump performance, monitors the Impella position information regarding the location of the pump across the aortic valve. The controller can be powered by AC power or can operate on internal battery power for at least 60 minutes when fully charged.

This section of the manual discusses Impella

2.5 for alarms, and provides real time catheter

Controller features and displays.

4 USING THE IMPELLA

CONTROLLER

Impella® Controller with Impella® 2.5

4.1

IMPELLA® CONTROLLER FEATURES

Figure 4.1 illustrates the features of the Impella® Controller. These features are described in Table 4.1.

4.2

Figure 4.1 Impella® Controller Features – Front and Side Views

Instructions for Use

Table 4.1 Impella

Controller Features

Feature Description

Display screen Displays user information, including the labels for the soft buttons.

(Display screen elements described in detail later in this section.)

Soft buttons Display, open, navigate, and close menus. The function for each soft button is

deﬁned by labels adjacent to the button on the display screen; function changes depending on the screen. (Soft button functions are described in Table 4.2)

When the pump is running the default soft button labels are as follows:

• MUTE ALARM

• TARGET FLOW

• DISPLAY

• PURGE SYSTEM

• MENU

Selector knob Rotating push button; turn clockwise and counterclockwise to scroll through

menu items; push to make a selection. NOTE: In many situations, selector knob function is circular—that is, once

you scroll to the end of the list of selections, the system circles through the list again as you continue to turn the knob. On some screens, however, the selector knob function is NOT circular and you must turn the knob in the reverse direction to get to previous items.

Pump plug Connection point on the controller for the Impella

Purge cassette

Spring-loaded door that opens to provide access to the purge cassette

door

Purge cassette Contains the components for circulating purge ﬂuid; maintains the pressure

barrier between the blood and the motor at the proper level. (The purge cassette and its components are described in Section 3 of this manual.)

Purge pressure transmitter

Applies pressure to the transducer in the controller so that purge presure can be measured

Bed mount Metal bracket on the back of the controller; attaches controller to the bed

Purge cassette door release

RS-232 service

Located on the left side of the controller; press to open the purge cassette door

Interface for data transfer to an external device

jack

USB connector Connection for downloading data

Ethernet jack Connection for downloading data or software upgrades

Equipotential

Used to ground the Impella

Controller according to hospital procedures

ground stud

AC fuses Electrical safety device in the event of current overload

Power cord

For mounting power cord retainer

retainer mounting holes

Power switch Turns the controller ON or OFF

• ON: Press and hold the power switch key for 3 seconds

• OFF: (1) Disconnect the Impella

Catheter from the Impella® Controller. (2) Press and hold the power switch for 3 seconds. (3) Press OK to conﬁrm that the controller should be turned off.

NOTE: Holding down the power switch for longer than 30 seconds during operation will cause the controller to initiate hardware switch-off

AC plug Connection point on the controller for the AC power cord

pump

4 USING THE IMPELLA

CONTROLLER

Impella® Controller with Impella® 2.5

4.3

IMPELLA® CONTROLLER HOME SCREEN DISPLAY

The home screen displays operating parameters and information for the entire system.

Figure 4.2 illustrates the Impella described in Table 4.2.

Controller home screen display. Each element of the display is

Figure 4.2 Impella® Controller Home Screen Display

Table 4.2 Impella

Controller Display Elements

Display Element Description

Patient identiﬁcation (ID) Displayed in the upper left corner of the display screen if the

information has been entered. The Patient ID can be up to 31 characters in length.

Pump serial number Displayed in the upper center of the display screen if a blood pump is

connected to the controller.

System date and time The current date and time (24-hour format) are displayed in the upper

right corner of the screen display.

Alarm window The alarm window displays up to 3 alarms simultaneously, in order of

priority from top to bottom. For each alarm, the alarm window displays:

• Alarm header – displayed in the left column; window is color-

coded red for critical alarms, yellow for warning alarms, white for advisory notiﬁcations, gray for resolved alarms

• Alarm subhead (if applicable) – further describes the alarm

condition

• Detailed text – up to 3 lines of instructions for resolving the alarm

condition are displayed in the right column of the alarm window next to the alarm header and subhead information

(See Section 10 of this manual for further discussion of Alarms.)

4.4

Instructions for Use

Table 4.2 Impella

Controller Display Elements (cont’d)

Display Element Description

Supply line Carries ﬂuid from the purge ﬂuid bag to the purge cassette

Mute Alarm indicator Displayed below the system date and time in the upper right

of the display screen. (See Section 10 of this manual for more information about the Mute Alarm function.)

• Yellow bell with red X displayed when an alarm is muted.

• Not displayed when an alarm is active but not muted or when

there are no active alarms.

Soft button labels The soft buttons on the Impella® Controller have corresponding

labels adjacent to them on the display screen. These labels change depending on the type of screen displayed.

MUTE ALARM

• Mutes (silences) active alarms

TARGET FLOW (or NEXT)

• TARGET FLOW – Brings up the target ﬂow icon, which enables users to set the current ﬂow rate for the Impella 2.5

• NEXT – Advances to the next screen

DISPLAY (or BACK)

• DISPLAY – Brings up the Display menu for viewing waveforms and navigating to other screen displays

• BACK – Returns to the previous screen

PURGE SYSTEM (or EXIT)

• PURGE SYSTEM – Brings up the Purge System menu for making changes in purge ﬂuid, purge cassette, or the purge system, or de-airing the purge system

• EXIT – Exits the current procedure

MENU (or Exit Repositioning Guide)

• MENU – Brings up a menu of options related to controller settings, alarm history, repositioning, and starting a procedure

• Exit Repositioning Guide – Exits the repositioning guide

System power area System power information is displayed to the right of the purge

system information on the bottom of the display screen Battery status

• Bar within battery symbol indicates the overall remaining

capacity of the batteries

• Full green bar for fully charged battery

• Partial green bar for battery that is at least 50% charged

• Partial yellow bar for battery that is between 25% and 50%

charged

• Partial red bar for battery that is less than 25% charged

• Moving gray bar indicates battery is in charging mode

• Numeric percentage of battery power remaining displayed

below the battery icon

AC plug indicator

• Green plug symbol indicates that the controller is running on AC

power

• Gray plug icon with a red X indicates no AC power detected

and the controller is running on battery power

4 USING THE IMPELLA

CONTROLLER

Impella® Controller with Impella® 2.5

4.5

Table 4.2 Impella

Controller Display Elements (cont’d)

Display Element Description

Purge system area Information about the purge system is displayed to the right of

the ﬂow area at the bottom of the display screen Purge system marquee

• Strobes from left to right when the purge system is operating

• Slow strobing represents normal purge ow rate

• Fast strobing represents bolus ow rate

Purge rate

• Current purge rate displayed in mL/hr below the purge system

marquee if the purge rate is known

• Not displayed if there is no purge cassette or the procedure has

not yet started

Time remaining in reservoir

• Displays the remaining runtime based on the volume of the

purge ﬂuid bag at the start of the case and the cumulative time and ﬂow rate of delivery of purge ﬂuid

• Not displayed if there is no purge cassette or the procedure has

not yet started

Flow area Information about Impella® ﬂow is displayed in the lower left

corner of the display screen Current ﬂow rate

• Mean pump ow displayed in liters per minute (L/min)— the numbers appear in white if the pump position is correct; yellow if the pump position is incorrect or unknown

• If the system is unable to calculate ow, a yellow triangular

caution icon is displayed with the message “Flow Calculation Disabled”

Pump icon

• The circular pump icon rotates when the blood pump is running

Central display area On the home screen, the central display area displays a heart

pictogram and Impella® position indicator message. Heart pictogram appears in the center of the home screen display

• Provides a visual representation of the current Impella® pump

position

• Overlaid with a translucent yellow “?” when the controller

detects an incorrect pump position or cannot detect pump position

Impella® position indicator message displayed to the left of the heart image

• Displays “Impella® Position OK” in green when pump position

is correct

• Displays “Impella® Position Unknown” in yellow when pump

position is unknown

• Displays specic message in yellow when pump position is

incorrect

4.6

Instructions for Use

IMPELLA® CONTROLLER WAVEFORM SCREEN DISPLAY

The waveform screen (see Figure 4.3) displays operating data for the system. The screen displays up to two waveforms and current pump data in the central display area of the screen.

4 USING THE IMPELLA

CONTROLLER

Figure 4.3 Waveform Screen Display (Waveform TBD)

Figure 4.3 shows two time-based waveform signals from different sources.

• Placement signal waveform

• Motor current waveform

PLACEMENT SIGNAL WAVEFORM

The placement signal waveform displays a pressure measurement that corresponds to the location of the open pressure area of the catheter. The placement signal is used to verify the position of the microaxial blood pump by evaluating the current pressure waveform as an aortic or ventricular waveform. The scale for the placement signal waveform is displayed to the left of the waveform. The default scaling is 0–160 mmHg in 20 mmHg increments, with a minimum upper limit of 100 mmHg and a maximum upper limit of 240 mmHg for the Impella 2.5.

To the left of the waveform is a display that labels the waveform, provides the units of measurement, shows the upper and lower range values, and the average value from the samples received from the last value update. At the bottom of that window is the time scale, which can be set to 10 seconds, 5 minutes, or 5 hours using the DISPLAY soft button. The default time scale is 10 seconds.

Impella® Controller with Impella® 2.5

4.7

Motor Current

Motor current is the measurement of electricity through the Impella required to rotate the

Impella

microaxial pump.

motor

MOTOR CURRENT WAVEFORM

The motor current waveform is a measurement of the electricity through the pump motor. The scale for the motor current waveform is displayed to the left of the waveform. The default scaling is 0–1000 mA in 100 mA increments for the Impella 2.5, with a minimum difference between upper and lower limits of 200 mA and a maximum difference of 1000 mA.

To the left of the waveform is a display that labels the waveform, provides the units of measurement, shows the upper and lower range values, and the average value from the samples received from the last value update. The time scale at the bottom of that window can be set to 10 seconds, 5 minutes, or 5 hours using the DISPLAY soft button. The default time scale is 10 seconds.

4.8

Instructions for Use

5 USING THE IMPELLA® CONTROLLER

WITH THE IMPELLA® 2.5

STARTUP ....................................................................................................... 5.1

Turning ON the Impella

Controller .................................................................. 5.1

The Startup Screen ..........................................................................................5.2

Starting a Case Procedure................................................................................ 5.2

CASE START ..................................................................................................5.3

Overview .........................................................................................................5.3

Initial Setup .....................................................................................................5.3

Prime Purge Tubing .........................................................................................5.4

Enter Purge Fluid Data .....................................................................................5.5

Plug Impella

Prime Impella

into Controller ...........................................................................5.6

Purge Lumen ...........................................................................5.6

Prime Blood Pressure Lumen ............................................................................5.7

Pre-Insertion Impella

Impella

Test Successful ..................................................................................5.7

INSERTING THE IMPELLA

POSITIONING AND STARTING THE IMPELLA

Test ..............................................................................5.7

2.5 CATHETER ...................................................5.8

2.5 CATHETER .................... 5.11

USE OF THE REPOSITIONING INTRODUCER

AND THE 13 Fr PEEL-AWAY INTRODUCER ..................................................5.14

PURGER PROCEDURES ...............................................................................5.15

Purge System Change .................................................................................... 5.15

Purge Fluid Change ....................................................................................... 5.16

Purge Cassette Change ................................................................................. 5.16

De-Air Purge System ...................................................................................... 5.17

TROUBLESHOOTING THE PURGE SYSTEM .................................................. 5.18

Low Purge Pressure .......................................................................................5.18

High Purge Pressure ...................................................................................... 5.18

Purge System Blocked .................................................................................... 5.18

PATIENT WEANING ..................................................................................... 5.19

Rapid Weaning .............................................................................................. 5.19

Slow Weaning ............................................................................................... 5.19

STARTUP

NOT

use an Impella® 2.5 System if any part of the system is damaged.

NOT

resterilize or reuse the Impella® 2.5 Catheter. It is a disposable device and

is intended for single use only.

To prevent malfunction of the Impella® Controller, avoid long-term exposure to direct sunlight and excessive heat (40°C).

5 USING THE IMPELLA

CONTROLLER WITH THE IMPELLA

To prevent overheating and improper operation, do NOT block the cooling vents of the Impella

Controller while it is operating.

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

TURNING ON THE IMPELLA® CONTROLLER

To turn the controller ON:

1. Press and hold the power switch on the right side of the Impella

seconds (see Figure 5.1).

Controller for 3

2.5

Figure 5.1 Impella® Controller Power Switch

The Impella® Controller automatically performs a system test when turned ON.

A display bar shows the progress of the system test. If the system test passes, the system displays the startup screen (see Figure 5.2).

Impella® Controller with Impella® 2.5

5.1

If the system test fails, the controller displays a system self check failure message:

SYSTEM SELF CHECK FAILED.

CHANGE CONSOLE IMMEDIATELY.

The controller displays the reason for the system test failure at the bottom of the screen.

THE STARTUP SCREEN

The startup screen (Figure 5.2) appears when you successfully turn ON the Impella® Controller.

Figure 5.2 Impella® Controller Startup Screen

The startup screen displays:

• The current status of the Impella

pump (currently no pump connected to the Impella®

Controller in Figure 5.2).

• The current status of the purge cassette (no purge cassette detected in Figure 5.2).

• The current version of the software that the Impella

Controller is running.

The startup screen also displays system power information along the bottom of the screen and two active soft buttons—MUTE ALARM and MENU—along the right side of the screen.

STARTING A CASE PROCEDURE

To start a case procedure:

1. Press the MENU soft button from the startup screen.

2. Scroll the selector knob to “Case Start” on the pop-up menu that appears on the screen.

3. Press the selector knob to select “Case Start”.

After you press the selector knob to select “Case Start” from the menu, the controller displays

an 8-screen series that leads you from initial setup through the pre-insertion Impella

test.

5.2

Instructions for Use

CASE START

5 USING THE IMPELLA

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

NOT

remove the Impella® 2.5 Catheter over the length of the guidewire.

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.

NOT

touch the inlet or outlet areas of the catheter and avoid manual

compression of the inlet cannula assembly while placing the device.

Do not kink or clamp the Impella® 2.5 Catheter or the 13 Fr peel-away introducer.

OVERVIEW

You will need the following materials to complete the setup before starting the case:

• 500 cc bag of D20 with 50 IU of heparin per cc. (Recommended)

Sensitive Medical Device

The Impella is a sensitive medical device with a microaxial pump with extremely ﬁne tolerances. In particular, the inﬂow and outﬂow areas of the distal and proximal areas of the pump assembly may be damaged if subjected to strong external forces.

2.5 Catheter

CONTROLLER WITH THE IMPELLA

2.5

• IV ush solution (NaCl) with pressure bag and 96 inches of sterile infusion line. NOTE: The distal end of the infusion line must remain sterile.

The Impella

Controller displays eight screens of instructions to lead you through a case start:

• Initial setup

• Prime purge tubing

• Enter purge uid data

• Plug Impella

• Prime Impella

into controller

purge lumen

• Prime blood pressure lumen

• Pre-insertion Impella

• Impella

test successful

test

INITIAL SETUP

1. Open the purge cassette package.

2. Using sterile technique, connect the purge ﬂuid spike to the spike connector on the

end of the purge ﬂuid supply line. Secure the yellow luer connector and pass the purge

cassette and supply line to the Impella

Controller operator.

Shaded Steps

All shaded steps require sterile technique.

Impella® Controller with Impella® 2.5

5.3

Selector Knob Function

3. Open the purge cassette door by pressing the release on the left side of the controller.

Insert the purge cassette into the Impella

Controller (as shown in Figure 5.3).

The selector knob function here is NOT circular (you CANNOT keep turning the knob in one direction to scroll between START and STOP). Turn the knob clockwise to scroll to STOP and counterclockwise to scroll to START.

• The purge cassette snaps into a molded compartment on the front of the controller.

Follow the diagram on the inside of the purge cassette door for proper placement.

• Slide the purge pressure transmitter into the slot to the right of the purge cassette

until it snaps into place.

• Extend the purge line and close the purge cassette door. There is sufcient room

around the edges of the purge cassette door so that it will not pinch the purge line as it exits.

Figure 5.3 Inserting Purge Cassette into Impella® Controller

4. Spike the purge ﬂuid bag with the purge ﬂuid spike attached to the end of the supply

line and hang the purge ﬂuid bag.

5. Press the NEXT soft button to advance to the next screen.

PRIME PURGE TUBING

1. Use the selector knob to scroll to START on the screen and press the knob to begin

priming the purge line. The controller will start the priming process at a bolus rate of 250 mL/hr or greater.

2. When purge ﬂuid is discharged from the tip of the yellow Impella

connector at the end of the purge line, scroll to STOP and press the selector knob to stop the ﬂow of purge ﬂuid.

3. Press NEXT after selecting STOP to proceed to entering purge ﬂuid data.

If you press the BACK button on this screen, the controller will return to step 1 of priming the purge tubing.

If you do not press STOP within 60 seconds of pressing START, you will get a message that the purger has stopped. Press BACK if additional purging is required. If the purge ﬂuid has been discharged from the purge tubing and priming is complete, press NEXT.

5.4

Instructions for Use

ENTER PURGE FLUID DATA

The Impella

Controller displays a table of recommended default values for the purge ﬂuid

(see Figure 5.4).

5 USING THE IMPELLA

System Timeout

1. To select the default values displayed on the screen, scroll to OK below the table and

press the selector knob. This will select those values and automatically advance you to the next screen.

The purger will stop after 60 seconds if the user does not press STOP. If this happens, press BACK for additional priming or NEXT if purge ﬂuid has been discharged.

CONTROLLER WITH THE IMPELLA

2.5

Figure 5.4 Default Values for Purge Fluid

2. To change the purge ﬂuid information, scroll to the appropriate item push the selector

knob to select it. Then scroll through the values and push the selector knob to make a new selection. The controller will use the default values if no other selections are made.

• Purge uid can be set to 100 mL, 250 mL, 500 mL (the default), or 1000 mL.

• Dextrose concentration can be set to 5%, 10%, 20% (the default), 30%, or 40%.

• Heparin concentration can be set to 0, 5, 10, 12.5, 15, 20, 25, or 50 units/mL. (50

units/mL is the default.)

Impella® Controller with Impella® 2.5

5.5

PLUG IMPELLA® INTO CONTROLLER

Important Step

Snapping the plastic hook on the pressure reservoir to the connector cable is important to prevent the tube from kinking.

Time Delay

Expect a 5 to 10 second time delay after plugging in the Impella before the Impella automatically advances to the next screen.

Infusion Bag Pressure

pump and

Controller

1. Open the Impella® Catheter package using sterile technique and snap the plastic hook

(located on the pressure reservoir of the clear sidearm) to the connector cable as shown in Figure 5.5.

Figure 5.5 Snapping Plastic Hook to Connector Cable

2. Pass the sterile white connector cable from the Impella® pump off the sterile ﬁeld. Line

up the notch on the Impella the front of the Impella

3. When the Impella

the Impella

ﬂow icon appears on the screen. The controller automatically advances to

Controller detects that an operational Impella® pump is plugged in,

connector cable with the notch in the blue pump plug on

Controller and plug the cable into the controller.

the next screen.

If the infusion bag is underinﬂated, the progress bar will not be activated. If the infusion bag is overinﬂated, an alarm will occur.

If a “Sensor Value not Reliable” alarm appears while priming the catheter, check that the pressurized saline bag is inﬂated to a pressure between 300 and 350 mmHg and not overinﬂated.

5.6

PRIME IMPELLA

PURGE LUMEN

1. Connect the yellow connector on the end of the purge line to the yellow luer connector

on the clear sidearm of the Impella

2. Select START to begin priming the Impella

pump.

purge lumen. The Impella® Controller will

start at a bolus rate of 250 mL/hour or greater.

3. When purge ﬂuid is discharged from the Impella

pump, scroll to and select STOP.

When you press STOP, the bolus stops but purge ﬂuid continues to ﬂow at a low rate.

4. Press NEXT to advance to the next screen.

Instructions for Use

PRIME BLOOD PRESSURE LUMEN

1. Using sterile technique, connect the ﬂush solution tubing to the red luer connector on

the red sidearm of the Impella

2. Blood pressure lumen priming starts automatically. Prime the Impella

pressure lumen by squeezing the white ﬂush valve until the Impella

pump.

Catheter

Controller beeps.

(see Figure 5.6).

When the system detects the target ﬂush solution pressure within the required amount of time (60 seconds), the system will go to the next step automatically.

5 USING THE IMPELLA

CONTROLLER WITH THE IMPELLA

Figure 5.6 Squeezing the White Flush Valve to Prime the Impella

Catheter Pressure Lumen

PRE-INSERTION IMPELLA® TEST

1. Select TEST to start the pre-insertion Impella® test.

The test runs for 2 seconds. When the system detects that the pump is spinning, it

automatically advances to the next step.

If the pre-insertion test fails, the system will instruct you to unplug the Impella

from the controller and disconnect the purge and ﬂush lines from the Impella

connectors. You can then press NEXT to set up a new Impella

IMPELLA

TEST SUCCESSFUL

pump.

luer

2.5

1. This screen tells you that the Impella® test was successful. Press NEXT to ﬁnish Startup.

Impella® Controller with Impella® 2.5

5.7

Use Fluoroscopy for Placement

INSERTING THE IMPELLA® 2.5 CATHETER

NOTE – Proper surgical procedures and techniques are the responsibility of the medical professional. The described procedure is furnished for information purposes only. Each physician must evaluate the appropriateness of the procedure based on his or her medical training and experience, the type of procedure, and the type of systems used.

Impella will be compromised if correct placement cannot be conﬁrmed. While other imaging techniques, such as transesophageal echocardiography (TEE), can help conﬁrm the position of the Impella placement, TEE does not allow visualization of the entire catheter assembly and is inadequate for reliably placing the Impella across the aortic valve.

Maintaining ACT

After insertion of the catheter (and until explant), ACT should be maintained at 160 to 180 seconds.

2.5 performance

2.5 after

2.5

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

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.

Do not kink or clamp the Impella® 2.5 Catheter or the 13 Fr peel-away introducer.

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.

NOT

touch the inlet or outlet areas of the catheter and avoid manual

compression of the inlet cannula assembly while placing the device.

1. Obtain access to the femoral artery.

2. Insert a 6–8 Fr introducer over the 0.035 guidewire (provided) to pre-dilate the vessel.

3. Remove the 6–8 Fr introducer over the 0.035 guidewire and insert the 13 Fr peel-away

introducer with dilator (see Figure 5.7). While inserting the 13 Fr introducer, hold the shaft of the introducer to slide it into the artery.

5.8

Figure 5.7 Inserting the 13 Fr Peel-Away Introducer

4. Administer heparin. When the ACT is above 250, remove the 13 Fr dilator.

Instructions for Use

5. Insert a 6 Fr diagnostic catheter with diagnostic guidewire with no side holes (Judkins

Right, Multipurpose, or pigtail recommended, see Figure 5.8) into the 13 Fr introducer and advance it over a diagnostic guidewire into the left ventricle.

Impella® 2.5 Use in Open Heart Surgery

5 USING THE IMPELLA

CONTROLLER WITH THE IMPELLA

Figure 5.8 Inserting the 6 Fr Diagnostic Catheter

6. Remove the diagnostic guidewire and insert the supplied 0.018 in/260 cm placement

guidewire.

7. Advance the placement guidewire into the left ventricle until the ﬂoppy end and 3 to

4 cm of the stiffer part of the guidewire are visible in the left ventricle.

8. Remove the 6 Fr diagnostic catheter.

9. Wet the cannula with sterile water and backload the pigtail section of the catheter onto

the placement guidewire. One or two people can load the catheter on the guidewire.

One-person technique

a. Advance the guidewire into the Impella® Catheter and stabilize the cannula

between the ﬁngers as shown in Figure 5.9. This prevents pinching of the inlet port. The guidewire must exit the outlet port on the inner radius of the cannula, as shown by the arrow in Figure 5.9 and in Figure 5.10. The catheter can be hyperextended as necessary to ensure the guidewire exits on the inner radius of the cannula.

If the Impella the OR as part of open heart surgery, manipulation may be performed only through the 9 Fr steering catheter. Direct manipulation of the pump assembly through the aorta or ventricle may result in serious damage to the Impella device and serious injury to the patient.

Avoid Damaging Inﬂow Area

During placement of the Impella care to avoid damage to the inﬂow area while holding the catheter and loading the placement guidewire.

2.5 is used in

2.5 device, take

2.5

Two-person technique

b. The scrub assistant can help stabilize the catheter by holding the catheter proximal

to the motor. This will allow the implanting physician to visualize the inner radius. The guidewire must exit the outlet port on the inner radius of the catheter, as shown by the arrow in Figure 5.9 and in Figure 5.10. The physician can focus on advancing the guidewire and, if the cannula needs to be hyperextended, the scrub assistant is available to assist.

Impella® Controller with Impella® 2.5

5.9

Figure 5.9 Loading the Catheter on the Guidewire

Figure 5.10 Exiting of the Placement Guidewire from the Catheter

Do NOT Touch Inlet or Outlet Areas

While feeding the Impella through the 13 Fr introducer, hold the device at the cannula or motor housing. Do NOT touch the inlet area or the outlet area.

10. Advance the catheter through the hemostatic valve into the femoral artery

(see Figure 5.11) and along the placement guidewire into the left ventricle using a ﬁxed- wire technique. Follow the catheter under ﬂuoroscopy as it is advanced into the left ventricle, being careful not to coil the guidewire in the left ventricle.

Figure 5.11 Inserting the Impella® 2.5 Catheter

5.10

Instructions for Use

To prevent device failure, do not start the Impella® 2.5 Catheter until the guidewire has been removed.

NOT

remove the Impella® 2.5 Catheter over the length of the guidewire.

11. Remove the placement guidewire.

12. Conﬁrm that a ventricular waveform is displayed on the Impella

Controller.

POSITIONING AND STARTING THE IMPELLA® 2.5 CATHETER

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

1. Place the catheter plug at the same level as the patient’s heart.

2. Conﬁrm that a ventricular waveform is displayed on the Impella

(see Figure 5.12). If a ventricular waveform is not present, gently advance the catheter forward until a ventricular waveform is present on the placement signal screen.

Controller

5 USING THE IMPELLA

CONTROLLER WITH THE IMPELLA

2.5

Figure 5.12 Ventricular Waveform on Placement Signal Screen

Impella® Controller with Impella® 2.5

Importance of Proper Pump Placement

When the pump is not correctly placed, the patient does not proﬁt from the ﬂow rate shown on the controller and there is no effective unloading of the ventricle (hydraulic short circuit).

5.11

3. Pull the catheter back until an aortic waveform is present on the placement signal

screen (see Figure 5.13).

4. When the aortic waveform is present, pull the catheter back an additional 4 cm.

(The distance between adjacent markings on the catheter is 1 cm.) The pump should now be centered across the aortic valve.

Figure 5.13 Aortic Waveform on Placement Signal Screen

5. Press the TARGET FLOW soft button to open the ﬂow icon (see Figure 5.14)

5.12

Figure 5.14 Selecting Target Flow

Instructions for Use

6. Turn the selector knob to change the ﬂow rate from 0 L/min to 0.5 L/min.

7. Press the selector knob to select the new ﬂow rate.

8. The ﬂow icon in the lower left corner of the screen begins rotating when the Impella

pump begins to operate.

9. Increase the ﬂow rate to 2.5 L/min to conﬁrm correct and stable placement. Placement

should be veriﬁed with ﬂuoroscopy and with the placement signal screen (see Figure

5.15).

5 USING THE IMPELLA

Check Positioning at Maximum Flow

When the ﬂow rate is increased to maximum ﬂow, the device has a tendency to be drawn into the ventricle. Check positioning at maximum ﬂow to ensure proper placement throughout the performance level setting range.

CONTROLLER WITH THE IMPELLA

Figure 5.15 Conﬁrming Placement on the Placement Signal Screen

10. After correct placement has been achieved, adjust the ﬂow rate to the desired ﬂow.

Flow rates of TBD L/min will default back to TBD L/min after 5 minutes.

11. Reposition the catheter as necessary.

2.5

Impella® Controller with Impella® 2.5

5.13

Alternative to Waiting Until ACT < 150

If you do not want to wait until ACT is below 150 seconds before removing the device, you can remove the device and exchange the peel-away sheath with a non peel-away sheath and dilator over the wire. Then you can wait until ACT is below 150 seconds and remove the sheath without risk of bleeding.

USE OF THE REPOSITIONING INTRODUCER AND THE 13 Fr PEEL-AWAY INTRODUCER

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.

1. Flush the sidearm of the repositioning introducer located on the catheter shaft.

2. Carefully ﬂush the sidearm of the 13 Fr introducer and remove the 13 Fr peel-away

introducer completely from the artery over the catheter shaft and apply manual pressure above the puncture site.

3. Grasp the two “wings” and bend back until the valve assembly comes apart. Continue

to peel the two wings until the introducer is completely separated from the catheter shaft (see Figure 5.16).

5.14

Figure 5.16 Removing the 13 Fr Peel-Away Introducer

4. Attach a stopcock and ﬂush the repositioning sheath prior to advancing the sheath.

5. Place two deadend caps on the stopcock to prevent further usage. The sideport should

not be used to give medication or draw blood because the blood could potentially clot. Pressure bags should not be connected to the sideport of the repositioning sheath. If a pressure bag is connected, the sideport must have an infusion pump or ﬂow limiting valve in place to control the amount of ﬂuid administered to the patient.

6. Slide the repositioning introducer over the catheter shaft and advance it into the artery

to the yellow eyelet.

7. Secure the yellow section of the repositioning introducer by suturing it to the skin using

the provided eyelet.

Instructions for Use

8. Slide the proximal end of the anticontamination sleeve onto the yellow section of

the repositioning introducer. Lock the anchoring ring in place by turning it clockwise. Secure the catheter shaft in place by tightening the connected anchoring ring.

9. Carefully extend the anticontamination sleeve to maximum length and secure the end

by tightening the distal anchoring ring.

PURGER PROCEDURES

5 USING THE IMPELLA

CONTROLLER WITH THE IMPELLA

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.

There are four procedures for maintaining the Impella® purge system:

• Purge system change (cassette and purge uid)

• Purge uid change

• Purge cassette change

• De-air purge system

Each procedure can be accessed using the PURGE SYSTEM soft button.

This section describes each of those purger procedures.

PURGE SYSTEM CHANGE

These are the steps you will follow to change out the purge cassette and purge ﬂuid.

1. The purge system change out procedure begins with delivery of a bolus to the pressure

reservoir so that the reservoir can maintain purge pressure during the change out. After the bolus is delivered, the controller automatically proceeds to the next screen.

Replacement Time

If the purge ﬂow is more than 7 mL/hr or the dextrose concentration is less than 20%, replacement time will be less than 4 minutes. Replacement should always be performed as quickly as possible.

2.5

2. Disconnect and remove the used purge cassette. If you do not remove the cassette

within 20 seconds, the system will cancel and exit the purge system change procedure.

3. Insert a new purge cassette into the controller. Be sure to slide the purge pressure

transmitter into place and extend the purge line through the gap in the purge cassette door when you close the door.

4. Turn the selector knob to select START. Press the knob to begin priming the purge line.

5. When purge ﬂuid is discharged from the purge line, scroll to STOP and press the

selector knob.

6. Press NEXT to advance to the next screen and enter purge ﬂuid information.

7A. To select the default purge ﬂuid values displayed on the screen, scroll to and select OK.

This will select those values and automatically advance you to the next screen.

Impella® Controller with Impella® 2.5

5.15

7B. To change the purge ﬂuid information, scroll to the appropriate item and push the

selector knob to select it. Then scroll through the values and push the selector knob to make a new selection. (Refer to “Entering Purge Fluid Data” in the Startup discussion at the beginning of this section for a listing of purge ﬂuid, dextrose concentration, and heparin concentration options.) The controller will use the default values if no other selections are made.

8. Connect the yellow luer connector on the end of the purge line to the yellow luer

connector on the clear sidearm of the Impella

pump.

9. Press NEXT to exit and complete the procedure.

Purge Solution Bottles

If the purge solution is supplied in bottles, follow the same procedure as if supplied in bags.

PURGE FLUID CHANGE

These are the steps you will follow to change only the purge ﬂuid.

1. The purge ﬂuid change procedure begins with delivery of a bolus to the pressure

reservoir so that the reservoir can maintain purge pressure during the change. After the bolus is delivered, the controller automatically proceeds to the next screen.

2. Replace the purge ﬂuid bag. Press NEXT to advance to the next screen and enter purge

ﬂuid information.

3A. To select the default purge ﬂuid values displayed on the screen, scroll to and select OK.

This will select those values and automatically advance you to the next screen.

3B. To change the purge ﬂuid information, scroll to the appropriate item and push the

PURGE CASSETTE CHANGE

5.16

These are the steps you will follow to change only the purge cassette.

1. The purge cassette change procedure begins with delivery of a bolus to the pressure

reservoir so that the reservoir can maintains purge pressure during the change. After the bolus is delivered, the controller automatically proceeds to the next screen.

2. Disconnect and remove the used purge cassette. If you do not remove the cassette

within 20 seconds, the system will cancel and exit the purge cassette change procedure.

3. Insert a new purge cassette into the controller. Be sure to slide the purge pressure

transmitter into place and extend the purge line through the gap in the purge cassette door when you close the door.

4. Turn the selector knob to select START. Press the knob to begin priming the purge line.

Instructions for Use

5. When purge ﬂuid is discharged from the purge line, scroll to STOP and press the

selector knob.

6. Press NEXT to advance to the next screen and connect the purge cassette to the

Impella

pump.

7. Connect the yellow luer connector on the end of the purge line to the yellow luer

connector on the clear sidearm of the Impella

pump.

8. Press NEXT to exit and complete the procedure.

5 USING THE IMPELLA

DE-AIR PURGE SYSTEM

These are the steps you will follow to de-air the purge system. This procedure starts automatically when the “Air in Purge System” alarm occurs.

1. Make sure that the purge ﬂuid bag is NOT empty or inverted.

2. Disconnect the purge line from the yellow luer connector on the Impella

pump.

3. Press START to initiate the de-air function. The system automatically advances to the

next screen.

4. The next screen explains that the de-air procedure is taking place. Wait until the air

is removed from the purge system and the system automatically advances to the next screen.

5. Conﬁrm that the purge ﬂuid has been discharged from the purge line. If it has not,

press BACK to repeat the air removal process.

6. Connect the yellow luer connector on the end of the purge line to the yellow luer

connector on the clear sidearm of the Impella

pump.

7. Press EXIT to complete the de-air procedure.

CONTROLLER WITH THE IMPELLA

2.5

Impella® Controller with Impella® 2.5

5.17

Purge Pressure

Purge pressure can range from 300mmHg to 1100 mmHg.

The Impella algorithm maintains purge pressure within 50 mmHg of the target pressure.

Controller purge

TROUBLESHOOTING THE PURGE SYSTEM

LOW PURGE PRESSURE

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 below.

1. Inspect the purge system for leaks.

2. If there are no leaks, change to a purge ﬂuid with a higher dextrose concentration. To

do this, open the PURGE SYSTEM menu and select “Purge Fluid Change”. Follow the instructions on the screen. (Refer to “Purger Procedures” earlier in this section.)

3. If the pressure stabilizes, no other action is required.

If the purge pressure is not stable, proceed to Step 4.

4. If the low purge pressure alarms remain unresolved for more than 5 minutes, this may

be a sign of pump damage. Complete the following steps immediately:

a. Open the ﬂow icon and reduce the ﬂow rate to 0.5 L/min.

b. Slowly pull back on the Impella

aorta (approximately 20 cm for an average size patient; 1 cm marks are available on the catheter).

2.5 Catheter until the pump is in the descending

Unresolved High Purge Pressure Alarms

High purge pressure alarms that are not resolved by the recommendations provided could be an indication of a kink in the catheter located within the artery. In this case, the motor is no longer being purged and will eventually stop. Clinicians should consider replacing the

Impella

pump.

c. Conﬁrm that the pump is still running at a ﬂow rate of 0.5 L/min. Open the ﬂow

icon and reduce the ﬂow rate to 0 L/min.

d. Stop the Impella

e. Remove the Impella

pump and turn off the purge system.

2.5 Catheter with the use of ﬂuoroscopic imaging. If no ﬂuoroscopy is available, leave the pump in the descending aorta until imaging is available for visual assistance with pump integrity during removal.

HIGH PURGE PRESSURE

If the purge pressure exceeds 1100 mmHg, the Impella

Controller displays the high purge

pressure alarm message.

1. Inspect the purge system for kinks in the tubing.

2. If pressure remains high, decrease the concentration of dextrose in the purge solution

(eg, dextrose 10%).

PURGE SYSTEM BLOCKED

If a “Purge System Blocked” alarm occurs, the purge ﬂuid ﬂow stops.

1. Check the purge system tubing for kinks or blockages.

5.18

2. Decrease the concentration of dextrose in the purge solution.

3. Replace the purge cassette.

Instructions for Use

PATIENT WEANING

Weaning the patient from the Impella® 2.5 is at the discretion of the physician. (For more information, refer to “Guidelines for Explant” in Section 6: Patient Management Topics.)

The following weaning protocols are provided as guidance only.

5 USING THE IMPELLA

RAPID WEANING

1. Initiate rapid weaning by decreasing the Impella® ﬂow rate by 0.5 L/min at intervals of

NOT

several minutes. Do

decrease the Impella® ﬂow rate below 0.5 L/min as long as

the pump is in the ventricle.

2. When the Impella

0.5 L/min for

3. If the patient’s hemodynamics remain stable, decrease the Impella

ﬂow rate has been reduced by 0.5 L/min, maintain the patient at

at least 10 minutes

before discontinuing circulatory support.

ﬂow rate to

0.1 L/min, pull the catheter into the aorta, and stop the pump by reducing the ﬂow rate to 0 L/min.

4. Explant the catheter.

5. Follow institutional guidelines for percutaneous arterial closure.

6. Disconnect the connector cable from the Impella

Controller and turn the controller

OFF.

SLOW WEANING

1. Initiate slow weaning by decreasing the Impella

NOT

2 to 3 hours. Do

decrease the Impella® ﬂow rate below 0.5 L/min as long as the

ﬂow rate by 0.5 L/min at intervals of

pump is in the ventricle.

2. When the Impella

0.5 L/min for

3. If the patient’s hemodynamics remain stable, decrease the Impella

ﬂow rate has been reduced to 0.5 L/min, maintain the patient at

at least 2 to 3 hours

before discontinuing circulatory support.

ﬂow rate to

0.1 L/min, pull the catheter into the aorta, and stop the pump by reducing the ﬂow rate to 0 L/min.

Remove the Impella® 2.5 With Care

CONTROLLER WITH THE IMPELLA

2.5

4. Explant the catheter.

5. Follow institutional guidelines for percutaneous arterial closure.

6. Disconnect the connector cable from the Impella

Controller and turn the controller

OFF.

Impella® Controller with Impella® 2.5

Removal of the Impella device must be completed with care to avoid damage to the pump assembly.

2.5

5.19

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

Correct Position ...............................................................................................6.6

Impella

Fully in Ventricle ................................................................................6.7

Impella

Completely in the Aorta or Inlet and Outlet Area

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

Low Native Heart Pulsatility .............................................................................6.9

Impella

Outlet Area on or Near Aortic Valve ................................................. 6.10

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

HOW TO CHANGE TO BACKUP CONTROLLER .............................................6.15

EMERGENCY SHUTDOWN PROCEDURE .....................................................6.15

PATIENT MANAGEMENT OVERVIEW

The information and instructions in this section of the manual are not intended to supersede established medical procedures concerning patient care. Best practice, as determined by the medical community, should always be observed. In each case, the clinician must determine whether the application of information provided is appropriate for the particular clinical setting.

GENERAL PATIENT CARE CONSIDERATIONS

• Do not raise the head of the bed to higher than a 30-degree angle

• Use knee immobilizer as needed to maintain access site straight

• Perform dressing changes per hospital protocol, using aseptic technique

• Assess access site for bleeding and hematoma

• Be careful not to pull on the Impella

to another

Catheter when transferring a patient from one bed

6 PATIENT MANAGEMENT TOPICS

• Monitor pedal pulses

TRANSPORT WITHIN THE HOSPITAL

Patients supported with the Impella® 2.5 System may require transport within the hospital for

various reasons. Transport can be safe and simple for patients supported with Impella

Considerations for transport within the hospital:

• The Impella

Controller and Impella® 2.5 System are designed to operate on battery

power for at least 1 hour.

• Conrm that the battery capacity displayed on the controller is 100%.

• If transport time might be longer than 1 hour, bring an extension cord or conrm

that you will be able to connect the controller to AC power once you arrive at your destination.

• Use care when rolling the Impella

Controller cart, and pay close attention when going

over thresholds and through elevator doors.

• Do not stress the Impella

pump cable from the controller to the Impella® red plug.

2.5.

Note: If the Impella

Controller is allowed to discharge completely, and the system shuts down due to low battery, the controller will need to charge for an extended period of time before the controller will turn back on.

Impella® Controller with Impella® 2.5

6.1

RIGHT HEART FAILURE

The Impella® 2.5 is a left-side support device only. Patients being supported by the Impella® 2.5 should be monitored for signs of right heart failure.

Caregivers should monitor the patient closely for the following potential signs of right heart failure:

• Reduced output from the Impella

• Suction alarms

• Elevated lling pressures (CVP)

• Signs of liver failure

• Elevated pulmonary pressures

If the patient is exhibiting signs of right heart failure, the clinical team should assess the need for biventricular support.

2.5

CARDIOPULMONARY RESUSCITATION (CPR)

Cardiopulmonary resuscitation (CPR) should be initiated immediately if indicated for any patient

being supported by the Impella

If CPR is indicated, the following actions are recommended:

1. Initiate CPR per hospital protocol.

2. Reduce the Impella

3. When cardiac function has been restored:

a. Return the ﬂow rate to previous level.

b. Assess placement signals on the controller.

Note:

• During CPR, placement monitoring and ow calculations will not be accurate.

• If ows do not return to pre-CPR values, verify proper placement of device and sufcient

ﬁlling of left ventricle. If placement and ﬁlling are not satisfactory, it may be an indication that the device has been damaged.

2.5.

2.5 ﬂow rate to 1 L/min.

6.2

Instructions for Use

DEFIBRILLATION

6 PATIENT MANAGEMENT TOPICS

During deﬁbrillation, do

NOT

touch the pump, cables, or Impella® Controller.

Patients supported by the Impella® 2.5 System can be deﬁbrillated. However, caregivers should use caution during deﬁbrillation to ensure they do not touch the pump, cables, or controller.

ECG INTERFERENCE

Operating the Impella® Controller may cause interference with electrocardiogram (ECG) signals. Please check the electrode pads and leads for good ﬁxation and contact. If interference persists, activate the 50/100 Hz band-elimination ﬁlter or the 60/120 Hz band-elimination ﬁlter (also known as notch ﬁlter) on your ECG device. The ﬁlter frequency will be based on the AC power frequency for the country in which you are operating the equipment. If your ECG device does

not have the appropriate ﬁlters, disconnect the Impella to obtain an undisturbed signal. Please observe the battery status while running the Impella Controller off AC power.

Controller temporarily from AC power

LATEX

The Impella® Controller, Impella® 2.5, and all accessories approved by Abiomed, are 100% latex free.

POSITIONING AND PLACEMENT DEVICES

High quality ﬂuoroscopic imaging is the best method for determining pump position and is required for pump placement.

Alternative methods for determining pump position include:

• Portable C-Arm uoroscopy

• Transesophageal echocardiography (TEE)

• Chest x-ray

Use Fluoroscopy for Placement

2.5 performance

2.5 after

2.5

Impella® Controller with Impella® 2.5

6.3

Notes on Imaging:

All imaging technology represents the anatomy in two dimensions (2D). It is not possible to assess the interactions between the device and the intraventricular anatomy that occur in three dimensions (3D). If a positioning alarm occurs, Abiomed strongly recommends that the device be repositioned, even if the imaging view shows correct position. Abiomed strongly recommends

using ﬂuoroscopy to guide placement and positioning of the Impella

Circulatory Support device.

Alternative imaging techniques, such as transesophageal echocardiography (TEE), can be useful to conﬁrm the position of the Impella

2.5 after placement. However, TEE is inadequate to reliably perform correct placement across the aortic valve. TEE does not allow visualization of the entire catheter assembly.

SUCTION

Suction may occur if the blood volume available for the Impella® 2.5 pump is inadequate or

restricted. Suction limits the amount of support that the Impella and results in a decrease in arterial pressure and cardiac output. It can damage blood cells, leading to hemolysis. It may also be an indicator of right heart failure.

2.5 can provide to the patient

If this alarm occurs, follow the recommended actions in the alarm display by decreasing the ﬂow rate.

1. Check the pump for correct positioning using imaging. Reposition the device by rotating

or moving it into or out of the ventricle slightly. Either or both of these actions could help move the inlet of the device away from the interior ventricular wall.

2. Assess patient’s ﬂuid intake and output to conﬁrm adequate volume status.

3. Conﬁrm right ventricular function by assessing CVP or right side function on echo.

If CVP is not an option, check the pulmonary artery diastolic pressure to assess the patient volume status.

4. Return ﬂow rate to pre-alarm setting.

HEMOLYSIS

When blood is pumped, it is subjected to mechanical forces. Depending on the strength of the blood cells and the amount of force applied, the cells may be damaged, allowing hemoglobin to enter the plasma. Pumping forces can be generated by a variety of medical procedures including heart lung bypass, hemodialysis, or ventricular support device (VAD) support. Patient conditions—including pump position, pre-existing medical conditions, and small left ventricular volumes—may also play a role in patient susceptibility to hemolysis.

6.4

Instructions for Use

Patients who develop high levels of hemolysis may show signs of decreased hemoglobin levels, dark or blood-colored urine, and in some cases, acute renal failure. Plasma-free hemoglobin (PfHgb) is the best indicator to conﬁrm whether a patient is exposed to an unacceptable level of hemolysis. Clinically signiﬁcant hemolysis is deﬁned as two consecutive PfHgb measurements greater than 40 mg/dL. For surgical patients, the ﬁrst measurements must be at least 72 hours post-implant.

Management technique may differ depending on the underlying cause of hemolysis. Table 6.1 provides guidance for various circumstances.

Table 6.1 Guide for Managing Hemolysis in Various Circumstances

Condition Controller Indicators Clinical Indicators Management

Impella® inlet area in close proximity to intraventricular wall

Wrong pump position

Higher than needed ﬂow setting

Inadequate ﬁlling volume

Pre-existing patient conditions or other medical procedures

Note on imaging: All imaging technology represents the anatomy in two dimensions (2D). It is not possible to assess the interactions between the device and the intraventricular anatomy that occur in three dimensions (3D). Abiomed strongly recommends that the device be repositioned, even if the imaging view shows correct position.

• Suction alarms

• Lower than expected ows

• Position alarms

• Suction alarms

• Lower than expected ows

• There may be no controller

indicators

• Suction alarms

• Position alarms

• Suction alarms

• Lower than expected ows

N/A • Patient past medical history

Imaging (see note) • Reposition the device by rotating or moving the

• Normal hemodynamics

• Native recovery

• Low CVP

• Low PCWP

• Low AOP

• High PA pressures

• Right heart failure

• High urine output

• Increased bleeding or chest

tube drainage

• Current procedures or

treatments

device into or out of the ventricle slightly. Either or both of these actions could help move the inlet of the device away from the intraventricular wall.

• If repositioning will be delayed, reduce the ow

rate if tolerated by patient hemodynamics. Return to the target ﬂow rate after repositioning.

• Reassess position after ow rate has returned to

desired target value.

device into or out of the ventricle slightly. Either or both of these actions could help move the inlet of the device away from the intraventricular wall.

• If repositioning will be delayed, reduce the ow

rate if tolerated by patient hemodynamics. Return to the target ﬂow rate after repositioning.

• Reassess position after ow rate has returned to

desired target value.

1. Reduce ﬂow rate until patient pressure starts to drop.

2. Slowly increase ﬂow rate.

• Reduce the ow rate if tolerated by patient

hemodynamics.

• Correct I and O balance.

• Consider giving volume; additional volume will

expand the end systolic ventricular volume.

• Reduce PA pressure.

• Improve right heart function.

6 PATIENT MANAGEMENT TOPICS

Impella® Controller with Impella® 2.5

6.5

UNDERSTANDING AND MANAGING IMPELLA® POSITION ALARMS

The Impella® Controller continuously monitors the catheter based on the placement signal and the motor current.

• Placement Signal:

• Motor Current:

Is the signal characteristic of aortic or ventricular pressure?

Is the signal “pulsatile” or “attened”?

If the system alarms with one of the positioning alarms described below, ﬂuoroscopic imaging is

the best method for conrming position. You can also use TEE or a standard chest X-ray.

If the Impella

is either partly (just the pigtail) or completely in the ventricle, reposition the device under imaging guidance. If guidance is not available, use the repositioning guide to reestablish proper placement. (The repositioning guide is discussed later in this section.)

If the Impella

is completely out of the ventricle, do not attempt to reposition the device across the valve without a guidewire.

The following pages describe possible placement conditions and the associated signal characteristics and alarm messages as well as actions to take for each.

CORRECT POSITION

If the Impella® 2.5 Catheter is in the correct position, the waveform screen will appear as shown in Figure 6.1.

6.6

Figure 6.1 Correct Catheter Position

Instructions for Use

IMPELLA® FULLY IN VENTRICLE

If the Impella

2.5 Catheter is fully in the ventricle, the following alarm will appear:

Pump Position Wrong

In this situation, the waveform screen will appear as shown in Figure 6.2.

Repositioning Guide

The repositioning guide can also be used for correcting

Impella

positioning.

6 PATIENT MANAGEMENT TOPICS

Figure 6.2 Catheter Fully in Ventricle

Actions to take:

1. Under ﬂuoroscopic guidance, if available, reduce the ﬂow rate to 0.5 L/min and

carefully pull back the Impella

Catheter until the aortic waveform signal is showing.

2. When you see the aortic waveform signal, pull the catheter back an additional 4 cm.

Impella® Controller with Impella® 2.5

6.7

IMPELLA® COMPLETELY IN THE AORTA or INLET AND OUTLET AREA IN VENTRICLE AND PRESSURE PORT IN AORTA

If the Impella

2.5 Catheter is completely in the aorta or if the inlet and outlet areas are in the

ventricle and the pressure port is in the aorta, the following alarm will appear:

Pump Position Wrong

In this situation, the waveform screen will appear as shown in Figure 6.3.

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

Actions to take:

1. Under ﬂuoroscopic guidance, determine the pump position.

2. Reduce ﬂow rate to 0.5 L/min and reposition the pump as necessary.

3. If ﬂuoroscopic imaging is not available, reposition the pump according to the

repositioning guide.

4. If step 3 does not provide correct positioning, check the pump position by imaging

methods (ﬂuoroscopy, TEE, or chest x-ray).

6.8

Instructions for Use

LOW NATIVE HEART PULSATILITY

In a situation of low native heart pulsatility, the Impella

Controller may not be able to

determine the pump position. You may see the following alarm:

Pump position unknown due to low pulsatility.

In this situation, the waveform screen will appear as shown in Figure 6.4.

6 PATIENT MANAGEMENT TOPICS

Figure 6.4 Pump Position Unknown Due to Low Pulsatility [Waveform TBD; Motor Current y-axis scale to be revised]

Actions to take:

1. Assess cardiac function.

Impella® Controller with Impella® 2.5

6.9

IMPELLA® OUTLET AREA ON OR NEAR AORTIC VALVE

If the Impella

2.5 Catheter outlet area is on or near the aortic valve, the pump may be too deep

in the ventricle. The following alarm will appear:

Impella Outﬂow Blocked

In this situation, the waveform screen will appear as shown in Figure 6.5.

Figure 6.5 Impella® Outlet Area on or near Aortic Valve

Actions to take:

1. Assess and adjust pump position under ﬂuoroscopic guidance, if available.

2. If ﬂuoroscopic guidance is not available, reduce the ﬂow rate to 0.5 L/min and gently

pull the catheter back 2 cm and see if the condition resolves.

REPOSITIONING GUIDE

Abiomed strongly recommends using ﬂuoroscopy to guide placement and positioning of the

Impella available, you can use the repositioning guide to correct the position of the Impella across the aortic valve. The repositioning guide provides information about the current position of the Impella

Circulatory Support device. However, if ﬂuoroscopy or other imaging guidance is not

pump

pump and the actions required to reposition the pump.

6.10

Instructions for Use

To use the repositioning guide:

1. Press MENU and scroll to “Start Repositioning Guide.” Press the selector knob to

initiation the repositioning guide algorithm.

Figure 6.6 shows the ﬁrst screen of the repositioning guide. Follow the instructions in

the white instructional display area under the headline “Repositioning Guide Active”.

6 PATIENT MANAGEMENT TOPICS

Figure 6.6 First Repositioning Guide Screen

2. Press OK to conﬁrm reduction in ﬂow rate. The system will reduce ﬂow rate to 1 L/min.

3. Push the Impella

pump forward until the placement signal shows ventricular pressure

(see Figure 6.7).

Figure 6.7 Second Repositioning Guide Screen

Impella® Controller with Impella® 2.5

6.11

4. Pull the Impella® pump back until the placement signal shows aortic pressure

(see ﬁgure 6.8).

Figure 6.8 Third Repositioning Guide Screen

5. Pull the Impella® pump back 4 marks on the catheter. Each mark equals 1 centimeter.

6. Exit the Repositioning Guide using the Exit Repositioning Guide soft button (see

Figure 6.9). When you exit, the controller returns to the original ﬂow rate level.

6.12

Figure 6.9 Exit Repositioning Guide Screen

Instructions for Use

DATA SNAP SHOT RECORDING

The Impella® Controller can save real-time operating data for later analysis using the Data Snap Shot feature. Data Snap Shot is automatically turned on during certain alarm conditions to capture data for analysis. The user can also manually turn on the feature at any time to capture data for later analysis.

To manually access the Data Snap Shot feature:

1. Press MENU and scroll to “Data Snap Shot”. Press the selector knob.

2. The controller records data for a predeﬁned period of 10 minutes. To stop recording

data before the 10-minute time-out, select “Stop Data Snapshot” from the MENU.

INFUSION HISTORY

The Impella® Controller has an Infusion History screen that displays the amount of heparin and dextrose infused each hour. The calculations begin when the case start procedure is completed and ﬂow rate is greater than 0. The system stores at least 8 hours of data. Figure 6.10 shows a sample Infusion History screen.

6 PATIENT MANAGEMENT TOPICS

Saving Snap Shot Data

If you select “Start Data Snap Shot” while the controller is already saving snap shot data, the controller will start saving data to a different snap shot ﬁle. Note: Old data will be overwritten by new data if the snap shot data memory is full.

Figure 6.10 Infusion History Screen

As you can see, the current time period is displayed at the top of the list. This entry provides the heparin and dextrose infusion rates from the top of the current hour to the current time.

Impella® Controller with Impella® 2.5

6.13

OPERATING THE IMPELLA® 2.5 WITHOUT HEPARIN IN THE PURGE SOLUTION

The Impella® 2.5 is designed to be operated with a purge solution that contains heparin. 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 (HIT) or bleeding, physicians should use their clinical judgment in assessing 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 an alternative anticoagulant delivered systemically.

Do not add any alternative anticoagulant (such as a direct thrombin inhibitor) to the purge solution. The Impella

2.5 has not been tested with any alternative anticoagulants present

in the purge solution.

GUIDELINES FOR EXPLANT

Patients being supported with the Impella® 2.5 System should be evaluated for explant on a regular basis.

To evaluate patients for explant, reduce the Impella

2.5 ﬂow rate and look for the following

signs of native heart recovery:

• AO and CVP pressure remain stable

• Native ejections are visible on the patient pressure monitor

• Native ejections increase after volume loading challenge

• Echocardiography reveals pronounced aortic valve opening

If physicians see these signs of native heart recovery and the patient has demonstrated stable, ongoing recovery—including stable organ (eg, liver, kidney, lung) function—the patient should be considered for explant.

If the patient does not meet the criteria for explant, the patient should remain on Impella

2.5

support, or be transitioned to a longer term device.

6.14

Instructions for Use

HOW TO CHANGE TO BACKUP CONTROLLER

A backup Impella® Controller should be available at all times when a patient is on support. In

the event that the controller fails, follow the steps below to transition the Impella backup controller.

1. Conﬁrm that the backup controller is powered ON and ready.

2. Transfer the purge cassette and purge solution from the primary controller to the

backup controller.

3. Remove the white Impella

connector cable from the primary controller and plug it into

the pump plug on the front of the backup controller.

4. Once the Impella

pump is connected to the backup controller, the “Quick Start”

message will appear on the screen asking the user to conﬁrm re-starting the Impella

2.5 at the previously set ﬂow rate.

5. Press OK within 10 seconds to conﬁrm restarting the Impella

2.5 at the previously set

ﬂow rate.

pump to the

6 PATIENT MANAGEMENT TOPICS

EMERGENCY SHUTDOWN PROCEDURE

1. Press and hold the black power button for 30 seconds.

2. An “Emergency Shutdown Imminent” alarm will sound at 15 seconds.

3. The controller will shut down after 30 seconds.

NOTE: The Impella

4. Restart the controller.

pump will continue running at the last setting.

Impella® Controller with Impella® 2.5

6.15

7 CLEANING, STORAGE, DISPOSAL,

AND RETURNS

CLEANING .................................................................................................... 7.1

Cleaning the Impella

STORING THE IMPELLA

DISPOSING OF THE PUMP AND ACCESSORIES (EU) ..................................... 7.1

RETURNING AN IMPELLA

Controller and Connector Cable .................................... 7.1

CONTROLLER ........................................................ 7.1

PUMP TO ABIOMED (US) ................................... 7.1

CLEANING

CLEANING THE IMPELLA® CONTROLLER AND CONNECTOR CABLE

7 CLEANING, STORAGE, DISPOSAL, AND RETURNS

• Clean the Impella

Controller keypad and display with 70% isopropyl alcohol, or soap and

water.

• Clean the Impella

Controller housing with mild detergent.

• Do not allow any uids to enter the connector sockets.

• Clean the connector cable with 70% isopropyl alcohol.

STORING THE IMPELLA® CONTROLLER

• Place the Impella® Controller on a horizontal surface to prevent falling.

• Connect the AC power cord to an AC outlet.

• The battery may be destroyed if the Impella® Controller is stored with a depleted battery.

Storing the Controller

To keep the Impella Controller battery charged, the controller should be plugged into an AC outlet and switched to the ON position when it is stored.

DISPOSING OF THE PUMP AND ACCESSORIES (EU)

The Impella® pump and connector cable are disposable items that must be disposed of in accordance with hospital regulations for blood contaminated materials.

The Impella

Controller is marked according to Directive 2002/96/EEC. Devices sold within the

EEC can be returned to Abiomed Europe GmbH for correct disposal.

RETURNING AN IMPELLA® PUMP TO ABIOMED (US)

To return an Impella® pump to Abiomed, contact your local Clinical Consultant for an Abiomedapproved return kit (part number 0046-4000).* The kit includes instructions for returning the pump to Abiomed.

* Only available in the United States

Impella® Controller with Impella® 2.5

7.1

7.2

Instructions for Use

8 TERMINOLOGY, ABBREVIATIONS,

AND SYMBOLS

TERMINOLOGY, ABBREVIATIONS, AND SYMBOLS ......................................8.1

TERMINOLOGY, ABBREVIATIONS, AND SYMBOLS

Table 8.1 Terminology and Abbreviations

Hz Hertz

Pump identiﬁcation number

Pump housing Enclosure of the Impella

Pump

Purge pressure Pressure present in the Impella® 2.5 and in the infusion line

Purge system Impella® purge cassette used for rinsing the Impella® 2.5

Retrograde ﬂow

V Volt

VA Volt ampere (Watt)

Table 8.2 Symbols

Identiﬁcation number of the pump; stated on the package label and on the display screen

Central delivery unit of the Impella® 2.5, consisting of the motor, motor housing, pump housing, cannula with inlet and outlet, and pigtail at the tip

Reverse ﬂow through the intracardiac pump when the pump is at a standstill (eg, regurgitation)

8 TERMINOLOGY, ABBREVIATIONS, AND SYMBOLS

2009-02

Caution; comply with documents (eg, Instructions for Use)

Deﬁbrillator-proof type CF equipment

Keep dry

Storage temperature (eg, 0°C to 30°C)

Declares conformity with directive 93/42/EEC for medical devices

Date of manufacture (eg, February 2009)

Protect from sunlight!

Symbol for lot designation; the manufacturer’s lot designation must be stated after the LOT symbol

Impella® Controller with Impella® 2.5

8.1

Table 8.2 Symbols (cont’d)

REF 123456 Abiomed part number (eg, part number 123456)

SN 123456 Manufacturer’s serial number (eg, serial number 123456)

Non Sterile! The product is not sterile

2010-06

Use-by date (eg, use before June 2010)

Do not reuse

Sterilized using ethylene oxide

Electric scrap; must be disposed of separately. Must not be disposed of as domestic waste.

Protective Earth

Protection Class II equipment

8.2

Instructions for Use

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

IMPELLA® CONTROLLER MECHANICAL

Parameter Speciﬁcation

Temperature Operating: 10°C to 40°C (50°F to 104°F)

Storage: –15°C to 50°C (5°F to 122°F)

Relative Humidity Operating: 95%

Storage: 95%

Atmospheric Pressure Operating: 8000 ft (750 hPa) to –1000 ft (1050 hPa)

Storage: 18,000 ft (500 hPa) to –1000 ft (1050 hPa)

Dimensions Height: 351 mm

Width: 443 mm Depth: 236 mm

Dimensions – Packaged

Weight Maximum: 11.8 kg (26.1 lbs)

Weight – Packaged Maximum: 13.6 kg (30 lbs)

Maintenance and repair interval

Height: 508 mm Width: 559 mm Depth: 406 mm

12 months (Work must be performed by technicians authorized by Abiomed)

9 SYSTEM SPECIFICATIONS

IMPELLA® CONTROLLER ELECTRICAL

AC operation 100-230 VAC (nominal); 47-63 Hz; 1.1A

Internal battery operation 14.4 VDC (nominal); lithium ion

Characteristic values

Max. power consumption under load Device fuse Running time without AC power with fully

charged batteries

Electrical system Installation in accordance with pertinent

120 VA 2x2 A slow-blow At least 60 minutes (charging duration of at least

10 hours)

regulations is required for use in medical facilities (eg, VDE 0100, VDE 0107, or ICE stipulations). Observe country-speciﬁc regulations and national deviations.

Impella® Controller with Impella® 2.5

9.1

EQUIPMENT DESIGN

The Impella® Controller conforms to the applicable requirements of the following standards:

• UL 60601-1 (2003), 1st Edition

Medical Electrical Equipment, Part 1: General

Requirements for Safety

• CAN/CSA C22.2 No 601.1-M90 (1990; Reafrmed 2005), 2nd Edition

Medical Electrical

Equipment, Part 1: General Requirements for Safety

• EN 60601-1 (1990), 2nd Edition

Medical Electrical Equipment, Part 1: General

Requirements for Safety + A1(93) + A2(95) + A1.3(96)

• IEC 60601-1 (1988), 2nd Edition

Medical Electrical Equipment, Part 1: General

Requirements for Safety + A1(91) + A2(95)

• IEC 60601-1-2 (2001),

Medical Electrical Equipment, Part 1-2: General Requirements for

Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests

• IEC 60601-1-4 (2000), Edition 1.1 Consolidated Edition

Medical Electrical Equipment, Part 1-4: General Requirements for Safety – Collateral Standard: Programmable Electrical Medical Systems

• IEC 60601-1-1, (2000/12/01), 2nd Edition

Medical Electrical Equipment, Part 1-1: General Requirements for Safety – Collateral Standard: Safety Requirements for Medical Electrical Systems

• IEC 60601-1-8, (2003/08/01), Edition 1

Medical Electrical Equipment, Part 1-8: General Requirements for Safety – Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems

• IEC 60601-1-6, (2004/06/01), Edition 1

Medical Electrical Equipment, Part 1-6: General

Requirements for Safety – Collateral Standard: Usability

EQUIPMENT CLASSIFICATIONS

Type of protection against electric shock

Degree of protection against electric shock for Impella® Controller

Mode of operation Continuous.

Degree of protection against explosion hazard

Degree of protection against harmful ingress of water

IEC 60601-1: Class I degree of protection: CF deﬁbrillation-proof and internally powered. Relies not only on basic insulation against shock but also includes additional protection. Accomplished by providing means for connecting the equipment to the protective earth conductor of the ﬁxed wiring of the installation in a way that prevents if basic insulation

Class I Equipment.

Not suitable for use in the presence of a ﬂammable anesthetic mixture with air or with oxygen or nitrous oxide. Also not suitable for use in an oxygen-enriched atmosphere.

IEC 60529: IPX1 protected against dripping water.

accessible metal parts

fails

from becoming live

9.2

Instructions for Use

FEDERAL COMMUNICATIONS COMMISSION (FCC) NOTICE

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

1. This device may not cause harmful interference.

2. This device must accept any interference received, including interference that may cause undesired operation.

Changes or modiﬁcations not expressly approved by Abiomed, Inc. could void the user’s authority to operate this device.

ELECTROMAGNETIC COMPATIBILITY

9 SYSTEM SPECIFICATIONS

Portable and mobile RF communications equipment can affect medical electrical equipment.

Use of cables, other than those sold by Abiomed, may result in increased emissions or decreased immunity of the Impella

Controller.

NOTE: The EMC tables and other guidelines that are included in this manual provide information to the customer or user that is essential in determining the suitability of the equipment or system for the electromagnetic environment of use, and in managing the electromagnetic environment of use permit the equipment or system to perform to its intended use without disturbing other equipment and systems or non-medical electrical equipment.

Impella® Controller with Impella® 2.5

9.3

TABLE 201

Guidance and Manufacturer’s Declaration – Emissions, All Equipment and Systems

The Impella® Controller is intended for use in the electromagnetic environment speciﬁed below. The customer or user of the Impella® Controller should ensure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Enforcement – Guidance

RF Emissions CISPR 11

Harmonics IEC 61000-3-2

Flicker IEC 61000-3-3

Group 1 Class A

Class A The Impella® Controller is suitable for use in all

Complies

The Impella® Controller uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

TABLE 202

Guidance and Manufacturer’s Declaration – Immunity

Electromagnetic Environment – Guidance

Floors should be wood, concrete, or ceramic tile. If ﬂoors are synthetic, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Impella® Controller requires continued operation during power mains interruptions, it is recommended that the Impella® Controller be powered from an uninterruptible power supply or battery.

ﬁelds should be that of a typical location in a typical commercial or hospital environment.

Immunity Test

Electrostatic Discharge (ESD) IEC 61000-4-2

Electrical Fast Transient/burst

IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

Power Frequency 50/60Hz Magnetic Field

IEC 61000-4-8

IEC 60601 Test Level

±8 kV contact ±15 kV air

±2 kV Mains ±1 kV for input/

output lines

±1 kV Differential ±2 kV Common

> 95% dip for 0.5

cycle 60% dip for 5 cycles 30% dip for 25

cycles > 95% dip for 5

seconds

3 A/m 3 A/m Power frequency magnetic

Compliance Level

±8 kV contact ±15 kV air

±2 kV Mains ±1 kV for input/

output lines

±1 kV Differential ±2 kV Common

> 95% dip for 0.5

cycle 60% dip for 5 cycles 30% dip for 25

cycles > 95% dip for 5

seconds

9.4

Instructions for Use

TABLE 203

PED )1/5.3(=

PED )1/7(=

Guidance and Manufacturer’s Declaration – Emissions,

Equipment and Systems that are Life-Supporting

Electromagnetic Environment – Guidance

Portable and mobile RF communications equipment should be separated from the Impella® Controller by no less than the recommended separation distances calculated/listed below:

Immunity Test

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 60601 Test Level

10 Vrms

150 kHz to 80 MHz

10 V/m

Compliance Level

V1 = 10 Vrms

150 kHz to 80 MHz

E1 = 10 V/m

9 SYSTEM SPECIFICATIONS

IEC 61000-4-3

80 MHz to 2.5 GHz

80 to 800 MHz

800 MHz to 2.5 GHz

Where P is the maximum power rating in watts and D is the recommended separation distance in meters.

Field strengths from ﬁxed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels (V1 and E1).

Interference may occur in the vicinity of equipment containing a transmitter.

Impella® Controller with Impella® 2.5

9.5

PATIENT

Pd 3333.2

ENVIRONMENT

Recommended Separation Distances Between Portable and Mobile

RF Communications Equipment and the Impella

TABLE 205

Controller,

Equipment and Systems that are Life-Supporting

The Impella® Controller is intended for use in the electromagnetic environment in which radiated

The Impella® Controller and the

disturbances are controlled. The customer or user of the Impella® Controller can help prevent

components of the Impella

electromagnetic interference by maintaining a minimum distance between portable and mobile RF

Controller System are approved

communications equipment and the Impella® Controller as recommended below, according to the

for use within the patient

maximum output power of the communications equipment.

environment deﬁned in IEC

Maximum

60601-1-1 and in the ﬁgure

Output Power

below.

(Watts)

Recommended Separation Distances

for the Impella® Controller (m)

150 KHz to 80 MHz

80 to 800 MHz

800 MHz to 2.5 GHz

Figure 9.1 Impella® Controller Patient Environment

0.01 0.11667 0.11667 0.23333

0.1 0.36894 0.36894 0.73785

1 1.1667 1.1667 2.3333

10 3.6894 3.6894 7.3785

100 11.667 11.667 23.333

RFID Transmitter / Receiver Speciﬁcations

Frequency 13.56 MHz

Receiver bandwidth TBD

Effective radiated power TBD

Modulation TBD

9.6

Instructions for Use

ABIOMED Impella Controller Users Manual

Specifications and Main Features

Frequently Asked Questions

User Manual