ABIOMED
Circulatory Support Systems
Impella 2.5 Instructions for Use & Clinical Reference Manual Rev C Sept 2010
Instructions for Use & Clinical Reference Manual
136 Pages
Preview
Page 1
Impella 2.5 ®
with the Impella Console ®
Circulatory Support System
Instructions for Use & Clinical Reference Manual (United States only)
IMPORTANT NOTICE: Read this entire manual before using the 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. Information contained in this document is subject to change without notice. ©2010 Abiomed, Inc. All rights reserved. The ABIOMED logo and ABIOMED are trademarks of Abiomed, Inc. and are registered in the U.S.A. and certain foreign countries. Recovering hearts. Saving lives. is a trademark of Abiomed, Inc. Impella® is a trademark of Abiomed Europe GmbH, a wholly owned subsidiary of Abiomed, Inc., and is registered in the U.S.A. and certain foreign countries.
Impella® 2.5 With The Impella® Console Instructions for Use & Clinical Reference Manual (United States only)
Rx Only
Abiomed, Inc. 22 Cherry Hill Drive Danvers, MA 01923 978-777-5410 (voice) 978-777-8411 (fax) [email protected] (email) Abiomed Europe GmbH Neuenhofer Weg 3 52074 Aachen, Germany +49 (241) 8860-0 (voice) +49 (241) 8860-111 (fax) [email protected] (email) www.abiomed.com 24-Hour Emergency Hotlines: N. America 1-800-422-8666 Europe +49 (0) 1805 2246633 September 2010 Document No. 0046-9005 Rev. C
Table of Contents
Introduction Introduction... I 1 Warnings and Cautions Warnings... 1.1 Cautions... 1.2 2 Indications, Contraindications, and Potential Adverse Events Indications (United States)... 2.1 Contraindications (United States)... 2.1 Potential Adverse Events (United States)... 2.1 3 The Impella® 2.5 System Overview... 3.1 Impella® 2.5 Catheter... 3.4 Impella® Console... 3.6 Impella® Power Supply and Power Supply Cable... 3.6 Purge System... 3.8 Quick Set-up Kit... 3.10 Introducer Kit... 3.10 Additional Impella® 2.5 Catheter Components... 3.11 4 Using the Impella® Console Overview... 4.1 Impella® Console Function Keys... 4.2 Impella® Console Connections... 4.4 Impella® Console Display... 4.5 Selecting Performance Level... 4.6 Positioning Aids and Other Displays... 4.7 Mobile Operation... 4.11 5 Using the Impella® 2.5 System Startup... 5.1 Preparing the Impella® 2.5 System... 5.3 Inserting the Impella® 2.5 Catheter... 5.10 Positioning and Starting the Impella® 2.5 Catheter... 5.14 Use of the Repositioning Sheath and the 13 Fr Peel-Away Introducer... 5.15 Transferring from Quick Set-up to Standard Configuration... 5.16 Replacing the Purge Tubing... 5.17 Purge System Troubleshooting... 5.19 Patient Weaning... 5.24
6 Patient Management Topics Patient Management Overview... 6.1 General Patient Care Considerations . ... 6.1 Transport Within the Hospital... 6.2 Right Heart Failure... 6.2 ECG Interference... 6.3 Latex... 6.3 Positioning and Placement Devices... 6.3 Use of Echocardiography for Positioning of the Impella® 2.5 Catheter... 6.4 Understanding and Managing Impella® 2.5 Catheter Position Alarms... 6.11 Suction... 6.17 Hemolysis... 6.17 Maintaining the Placement Signal... 6.19 Operating the Impella® 2.5 Catheter Without Heparin in the Purge Solution... 6.20 How to Change to A Backup Console... 6.21 7 I mpella® Console Alarms and Warnings Impella® 2.5 Console Alarms... 7.1 Impella® 2.5 Console Warnings... 7.3 8 General System Information Terminology, Abbreviations, and Symbols... 8.1 Ambient Conditions... 8.3 Impella® 2.5 Catheter Parameters... 8.3 Impella® Console and Power Supply Parameters... 8.4 Connector Cable Parameters... 8.4 Impella® 2.5 Catheter Dimensions... 8.5 Anatomic Considerations... 8.6 Cleaning... 8.6 Storing the Impella® Console and the Power Supply... 8.7 Returning an Impella® 2.5 Catheter to Abiomed (United States)... 8.7 Appendices Appendix A: Impella® System Limited Service Warranty (United States)... A.1 Appendix B: Technical Safety Inspections, Maintenance, and Repair... B.1 Appendix C: Abiomed-approved Guidewires and Introducers... C.1 Appendix D: Setting Up the Impella® 2.5 Catheter Without the Quick Set-up Kit...D.1 Index
Table of Contents
Figures Figure 3.1 Figure 3.2
Impella® 2.5 Catheter in the Heart... 3.1 Quick Set-up Configuration of Impella® 2.5 System Components... 3.3 Figure 3.3 Standard Configuration of Impella® 2.5 System Components with Infusion Pump... 3.3 Figure 3.4 Impella® 2.5 Catheter... 3.4 Figure 3.5 Impella® Console... 3.6 Figure 3.6 Impella® Power Supply... 3.7 Figure 3.7 Impella® Power Supply Rear Panel... 3.7 Figure 3.8 Impella® Power Supply Cable... 3.8 Figure 3.9 B. Braun Vista® basic Infusion Pump... 3.9 Figure 3.10 1 L Pressure Bag... 3.10 Figure 3.11 Integrated Purge Tubing... 3.10 Figure 3.12 Introducer Kit... 3.10 Figure 3.13 Impella® Combitrans-Monitoring Set (CM-Set)... 3.11 Figure 3.14 Pressure Transducer Cable... 3.11 Figure 3.15 Connector Cable... 3.11 Figure 3.16 0.018 inch, 260 cm Placement Guidewire... 3.12 Figure 3.17 Purge Tubing... 3.12 Figure 3.18 Pump Test Plug... 3.12 Figure 3.19 Dextrose Solution... 3.12 Figure 4.1 Impella® Console Function Keys... 4.2 Figure 4.2 Impella® Console Display... 4.5 Figure 4.3 Ventricular and Aortic Waveforms on Placement Signal Screen. 4.7 Figure 4.4 Placement Monitoring Screen... 4.8 Figure 4.5 Dual Signal Screen... 4.8 Figure 4.6 Purge Pressure Screen... 4.9 Figure 4.7 Motor Current Screen... 4.9 Figure 4.8 Speed Screen... 4.10 Figure 4.9 Flow Rate Screen... 4.10 Figure 5.1 Placing the Impella® Power Supply Next to the Impella® Console... 5.1 Figure 5.2 Connecting the Power Supply Cable to the Power Supply... 5.2 Figure 5.3 Connecting the Power Supply Cable to the Console... 5.2 Figure 5.4 Turning the Power Supply On... 5.2 Figure 5.5 Flushing the Purge Line... 5.4 Figure 5.6 Inserting the Catheter Plug into the Connector Cable... 5.4 Figure 5.7 Snapping Plastic Clip to Connector Cable... 5.5 Figure 5.8 Attaching the Connector Cable to the Console... 5.5 Figure 5.9 Connecting the Pressure Cable Screen... 5.6 Figure 5.10 Connecting the Pressure Transducer Cable to the Console... 5.6 Figure 5.11 Priming the Impella® 2.5 Catheter Purge Lumen Screen... 5.7 Figure 5.12 Connecting the Quick Set-up Purge Tubing to the . Impella® 2.5 Catheter... 5.7 Figure 5.13 Squeezing the White Flush Valve to Prime the Pressure . Measurement Lumen... 5.8 Figure 5.14 Fluid Exiting Open Pressure Area and Outlet Area... 5.8 Figure 5.15 Ready to Insert Screen... 5.9 Figure 5.16 Impella® 2.5 System Configuration after Quick Set-up... 5.9 Figure 5.17 Inserting the 13 Fr Peel-Away Introducer... 5.10 Figure 5.18 Inserting the 6 Fr Diagnostic Catheter... 5.11 Figure 5.19 Loading the Catheter on the Guidewire... 5.12 Figure 5.20 Aligning the Placement Guidewire... 5.12 Figure 5.21 Inserting the Impella® 2.5 Catheter... 5.13 Figure 5.22 Aortic Waveform on Placement Signal Screen... 5.13 Figure 5.23 Confirming Placement on the Dual Signal Screen... 5.14
Figure 5.24 Removing the 13 Fr Peel-Away Introducer... 5.15 Figure 5.25 Impella® 2.5 System Configuration after Transition to Infusion Pump... 5.17 Figure 5.26 Impella® 2.5 System Configuration after Transitioning to Infusion Pump and Replacing Purge Tubing... 5.18 Figure 5.27 Low Purge Pressure Screen... 5.19 Figure 5.28 Normal Purge Pressure on 5 Minute Scale Screen... 5.20 Figure 5.29 Abnormal Purge Pressure on 5 Minute Scale Screen... 5.21 Figure 5.30 High Purge Pressure Screen... 5.22 Figure 5.31 Purge Management... 5.23 Figure 5.32 Downstream Occlusion Alarm... 5.24 Figure 5.33 Disconnecting the Connector Cable from the Console... 5.25 Figure 6.1 Labeled TEE and TTE Images of the Impella® 2.5 Catheter Position... 6.5 Figure 6.2 Transesophageal Echocardiographic (TEE) Illustrations of . Impella® 2.5 Catheter Position... 6.8 Figure 6.3 Transthoracic Echocardiographic (TTE) Illustrations of . Impella® 2.5 Catheter Position... 6.9 Figure 6.4 Correct and Incorrect Impella® 2.5 Catheter Position (Color Doppler TTE)... 6.10 Figure 6.5 Correct Impella® 2.5 Catheter Position... 6.12 Figure 6.6 Impella® 2.5 Catheter Fully in Ventricle... 6.13 Figure 6.7 Impella® 2.5 Catheter Completely in Aorta or Inlet and Outlet Areas in Ventricle and Open Pressure Area in Aorta... 6.14 Figure 6.8 Impella® 2.5 Catheter Position Unknown due to Low Pulsatility... 6.15 Figure 6.9 Impella® 2.5 Catheter Outlet Area on or near Aortic Valve... 6.16 Figure 8.1 Impella® 2.5 Catheter Dimensions... 8.5 Figure B.1 Inspection Sticker Showing Inspection Required in May 2010... B.1 Figure B.2 Impella® Console Information Screen... B.2 Figure D.1 Connecting the Pressure Cable Screen... D.2 Figure D.2 Impella® Console Display for Priming the Impella® 2.5 Catheter Purge Lumen... D.2 Figure D.3 Impella® Console Display for Priming the Pressure Measurement Lumen... D.3 Figure D.4 Impella® Console Display when Impella® 2.5 Catheter is Ready to Insert... D.3
Tables Table 3.1 Table 3.2 Table 3.3 Table 3.4 Table 3.5 Table 4.1 Table 4.2 Table 4.3 Table 4.4 Table 5.1 Table 5.2 Table 5.3 Table 6.2 Table C.1 Table C.2
Impella® 2.5 Set-up and Insertion Kit Components... 3.2 Impella® 2.5 Catheter Components... 3.4 Impella® 2.5 Quick Set-up Kit Components... 3.10 Introducer Kit... 3.10 Additional Impella® 2.5 System Components... 3.11 Impella® Console Function Keys... 4.3 Impella® Console Connections... 4.4 Impella® Console Display Elements... 4.5 Performance Level Flow Rates... 4.6 Handling Low Purge Pressure Alarms... 5.20 Amount of Dextrose Delivered in the Purge Fluid (g/h)... 5.23 Amount of Heparin Delivered in the Purge Fluid (IU/h)... 5.23 Recommendations for Periodic Flushing of Placement Signal . Lumen... 6.19 Alternative Guidewires... C.1 Alternative Introducer Sheaths... C.1
Introduction introduction
Purpose of Manual This Instructions for Use & Clinical Reference Manual is designed for healthcare professionals. It contains clinical and technical information to guide healthcare professionals in their use of the Impella® 2.5 System. The system performs life-sustaining functions. To use the system you must understand and follow these instructions as well as the instructions accompanying the infusion pump you are using. The Impella® 2.5 System may be used only for its intended purpose.
Manual Overview This manual provides instructions for use of the Impella® 2.5 System. The following summarizes the contents of each section of this manual. • Section 1: Warnings and Cautions discusses the warnings and cautions pertaining to the use of the Impella® 2.5 System. • Section 2: Indications, Contraindications, and Potential Adverse Events discusses indications for use of the Impella® 2.5 System, contraindications, and potential adverse events that may be associated with use of the system. • Section 3: The Impella® 2.5 System provides an overview of the system and describes its major components. • Section 4: Using the Impella® Console describes the controls and connections on the Impella® Console. • Section 5: Using the Impella® 2.5 System provides the procedures for using the system. • Section 6: Patient Management Topics provides key information on various topics related to management of patients with the Impella® 2.5 Circulatory Support System. • Section 7: Impella® Console Alarms and Warnings provides an alphabetical listing of Impella® Console alarms and warnings, as well as information on what to do to resolve them. • Section 8: General System Information contains information including definitions for key terms that appear in the manual, descriptions of the abbreviations and symbols that appear on Impella® 2.5 System components and packaging, technical information pertaining to the Impella® 2.5 System, and instructions on cleaning and storing system components as well as returning components to Abiomed. • Appendices at the end of the manual provide supplemental information about topics including the Impella® System Limited Service Warranty, technical safety inspection, maintenance and repair, Abiomed-approved guidewires and introducers, and setting up the Impella® 2.5 Catheter without the Quick Set-up kit.
Impella® 2.5 Catheter with Impella® Console
I
1 Warnings and Cautions
Warnings... 1.1 Cautions...1.2
Warnings
Fluoroscopy is required to guide placement of the Impella® 2.5 Catheter. The small placement guidewire must be reliably observed at all times. Avoid manual compression of the inlet and outlet areas of the cannula assembly.
Warnings Warnings alert you to situations that can cause death or serious injury. The red symbol appears before warning messages.
Avoid overinserting the catheter and possibly impinging the catheter tip against the walls of the vasculature, atrium, or ventricle. Do NOT advance or withdraw the Impella® 2.5 Catheter against resistance without using fluoroscopy to determine the cause of the resistance. Doing so could result in separation of the catheter or guidewire tip, damage to the catheter or vessel, or ventricular perforation. Be sure that the stopcock on the peel-away introducer or repositioning sheath is always kept in the closed position. Significant bleed back can result if the stopcock is open. The sterile components of the Impella® 2.5 System can be used only if the sterilization indicators show that the contents have been sterilized, the packaging is not damaged, and the expiration date has not elapsed. Do NOT resterilize or reuse the Impella® 2.5 Catheter. It is a disposable device and is intended for single use only. Reuse, reprocessing, or resterilization may compromise the structural integrity of the catheter and/or lead to catheter failure which, in turn, may result in patient injury, illness, or death. Retrograde flow will occur across the aortic valve if the Impella® 2.5 Catheter is set at performance level P0. To prevent 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. The infusion pump provided by Abiomed must NOT be used in conjunction with any products other than Impella® products. Do NOT use saline in the purge system. Do NOT use alcohol-based fluids for lubrication. 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. 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.
Impella® 2.5 Catheter with Impella® Console
1.1
1 WARNINGS AND CAUTIONS
The Impella® 2.5 System is intended for use only by personnel trained in accordance with the Abiomed® Training Program.
If at any time during the course of support with the Impella® 2.5 Catheter, the Impella® Console alarms “Low Purge Pressure,” follow the instructions presented in “Purge System Troubleshooting” in Section 5 of this manual. Do NOT subject a patient who has been implanted with an Impella® 2.5 Catheter to magnetic resonance imaging (MRI). The strong magnetic energy produced by an MRI machine may cause the Impella® 2.5 System components to stop working, and result in injuries to the patient. An MRI may also damage the electronics of the Impella® 2.5 System. During defibrillation, do NOT touch the Impella® 2.5 Catheter, cables, or Impella® Console. The Impella® 2.5 Introducer kit is sensitive to light. Do NOT use if stored outside the protective outer carton. Store in a cool, dark, and dry place. Infusion through the sideport of the introducer can be done only after all air is removed from the introducer. If performed, the infusion should be done for flushing purposes only and NOT for delivering therapy or monitoring blood pressure.
Cautions Cautions Cautions indicate a situation in which equipment may malfunction, be damaged, or cease to operate. The yellow symbol appears before caution messages.
Handle with care. The Impella® 2.5 Catheter can be damaged during removal from packaging, preparation, insertion, and removal. Do NOT bend, pull, or place excess pressure on the catheter or mechanical components at any time. Patients with aortic stenosis or other abnormal aortic valve performance may be compromised by the use of the Impella® 2.5 Catheter. Patients with aortic valve disease should be observed for aortic insufficiency. Use only original accessories and replacement parts supplied by Abiomed. Refer to the instructions for use supplied with the infusion pump being used before using the infusion pump with the Impella® 2.5 System. To troubleshoot purge system alarms not listed in this manual, refer to the appropriate infusion pump instructions for use manual. Holding down the ON key on the Impella® Console for longer than 3 seconds during operation will cause the Impella® Console to go into emergency stop mode. When conducting the Impella® Console function test as part of preventive maintenance, if a pressure value of 50 (± 4) mmHg does not appear or the speed is not within the specified range of 24,000 ± 1,000 revolutions per minute (rpm), do NOT use the Impella® Console. 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.
1.2
Instructions for Use & Clinical Reference Manual (US)
1 WARNINGS AND CAUTIONS
Do NOT remove the Impella® 2.5 Catheter over the length of the placement guidewire. When replacing the purge tubing, the replacement process must be completed within 2 minutes. The Impella® 2.5 Catheter may be damaged if replacement takes longer than 2 minutes. Protect the Impella® Console and the Impella® Power Supply from direct sunlight or exposure to excessive temperature (max. 40°C) to prevent malfunction. To prevent overheating and improper operation, do NOT block the cooling vents of the Impella® Power Supply while it is operating. Do NOT place the Impella® Console on top of the Impella® Power Supply. Do NOT kink or clamp any part of 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® Console 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. The use of high-frequency surgical devices may cause temporary interference with 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 Impella® 2.5 Catheter. Do NOT alter the Impella® 2.5 Introducer kit in any way. Aspiration and saline flushing of the Impella® 2.5 Introducer kit sheath, dilator, and valve should be performed to help minimize the potential for air embolism and clot formation. Indwelling introducer sheaths should be internally supported by a catheter, electrode, or dilator. Dilators, catheters, and pacing leads should be removed slowly from the sheath. Rapid removal may damage the valve, resulting in blood flow through the valve. Never advance the guidewire or sheath when resistance is met. Determine the cause of resistance using fluoroscopy and take remedial action. When injecting or aspirating through the sheath, use the sideport only.
Impella® 2.5 Catheter with Impella® Console
1.3
2 Indications, Contraindications, and Potential Adverse Events
Indications (United States)...2.1 Contraindications (United States)...2.1 Potential Adverse Events (United States)...2.1
Indications (United States) 2 Indications, contraindications, and Potential Adverse Events
The Impella® 2.5 Circulatory Support System is intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The Impella® 2.5 Circulatory Support System also provides pressure measurements which are useful in determining intravascular pressure.
Contraindications (United States) Patients with aortic stenosis or other abnormal aortic valve performance may be compromised by the use of the Impella® 2.5 Catheter. Patients with aortic valve disease should be observed for aortic insufficiency.
• Mechanical aortic valve or heart constrictive device. • Aortic valve stenosis/calcification (graded as ≥ +2 equivalent to an orifice area of 1.5 cm2 or less). • Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥ +2). • Severe peripheral arterial obstructive disease that would preclude Impella® 2.5 device placement.
Potential Adverse Events (United States) • Aortic insufficiency
• Insertion site infection
• Aortic valve injury
• Myocardial infarction
• Arrhythmia
• Perforation
• Atrial fibrillation
• Renal failure
• Bleeding
• Respiratory dysfunction
• Cardiac tamponade
• Sepsis
• Cardiogenic shock
• Thrombocytopenia
• Cerebral vascular accident (CVA) / Stroke
• Thrombotic vascular (non-CNS) complication
• Death
• Transient ischemic attack (TIA)
• Device malfunction
• Vascular injury
• Hemolysis
• Ventricular fibrillation
• Hepatic failure
• Ventricular tachycardia
Impella® 2.5 Catheter with Impella® Console
2.1
3 The Impella® 2.5 System
Overview...3.1 Reusable System Components... 3.1 Single-use System Components...3.2 Impella® 2.5 Set-up and Insertion Kit...3.2 System Configurations...3.2 Impella® 2.5 Catheter...3.4 Impella® Console...3.6 Impella® Power Supply and Power Supply Cable...3.6 Impella® Power Supply...3.6 Impella® Power Supply Cable...3.8 Purge System...3.8 Quick Set-up Kit...3.10 Introducer Kit...3.10 Additional Impella® 2.5 Catheter Components... 3.11
Overview 3 The Impella® 2.5 System
The Impella® 2.5 Catheter is an intravascular microaxial blood pump that supports a patient’s circulatory system. The catheter is inserted percutaneously through the femoral artery and into the left ventricle. (See Figure 3.1.)
Figure 3.1 Impella® 2.5 Catheter in the Heart
When properly positioned, the Impella® 2.5 Catheter delivers blood from the inlet area, which sits inside the left ventricle, through the cannula to the outlet opening in the ascending aorta. Physicians and device operators monitor the correct positioning and functioning of the Impella® 2.5 Catheter on the display screen of the Impella® Console. This section describes the components of the Impella® 2.5 System. Reusable System Components The Impella® 2.5 System consists of the following reusable components: • Impella® Console-provides the user interface, alarm indications, and portable battery • Impella® Power Supply and Power Supply cable-for continuous operation of the console • Infusion pump-for purging the Impella® 2.5 Catheter • Pressure transducer cable • Pump test plug
Impella® 2.5 Catheter with Impella® Console
3.1
Single-use System Components The system also includes the following single-use components: • Impella® 2.5 Catheter • Impella® Quick Set-up kit • Impella® Combitrans-Monitoring Set (CM-Set) • Introducer kit • 0.018 inch, 260 cm placement guidewire • Connector cable • Purge tubing Impella® 2.5 Set-up and Insertion Kit The components of the Impella® 2.5 System are packaged into a single box called the Impella® 2.5 Set-up and Insertion kit. Table 3.1 describes the contents of this kit. Table 3.1 Impella® 2.5 Set-up and Insertion Kit Components
The Impella® 2.5 Set-up and Insertion kit contains the following:
• Impella® 2.5 Catheter • 0.018 inch, 260 cm placement guidewire • Connector cable • Purge tubing • Impella® Combitrans-Monitoring Set (CM-Set) • Introducer kit »» 13 Fr peel-away introducer »» 13 Fr dilator »» 18 G Seldinger needle »» 10 cc syringe »» 0.035 inch stiff access guidewire
• Impella® Quick Set-up kit »» Integrated purge tubing (purge tubing, CM-Set, and Y adapter with color luer connectors) »» 1L pressure bag with high pressure capabilities
System Configurations Figure 3.2 illustrates the initial configuration of the Impella® 2.5 System components using the Quick Set-up kit. Figure 3.3 illustrates the Impella® 2.5 System components set up in the standard configuration with an infusion pump.
3.2
Instructions for Use & Clinical Reference Manual (US)
Power Supply
3 The Impella® 2.5 System
D20
Dextrose Solution
Power Supply Cable
Impella® 2.5 Catheter
Pressure Transducer Cable
Impella® Console
Connector Cable
Y-Connector Purge Tubing
Combitrans-Monitoring Set = connection
Figure 3.2 Quick Set-up Configuration of Impella® 2.5 System Components
D20
Dextrose Solution
Power Supply
Sodium Chloride (NaCl) Solution in Pressure Bag
Power Supply Cable Infusion Pump
Pressure Transducer Cable
Impella® 2.5 Catheter
Impella® Console
Connector Cable Purge Tubing
Combitrans-Monitoring Set = connection
Figure 3.3 S tandard Configuration of Impella® 2.5 System Components with Infusion Pump
Impella® 2.5 Catheter with Impella® Console
3.3
Impella® 2.5 Catheter The Impella® 2.5 Catheter is an intravascular microaxial blood pump that delivers up to 2.5 liters of blood per minute from the left ventricle into the aorta. Figure 3.4 illustrates the . Impella® 2.5 Catheter. Table 3.2 describes each component from the pigtail at one end to the check valve on the other end. Red Pressure Sidearm
Catheter Shaft
Red Impella Plug ®
Clear Sidearm Infusion Filter Pressure Reservoir Repositioning Unit
Pigtail Inlet Area
Check Valve
Cannula Motor Housing Open Pressure Area Outlet Area
Figure 3.4 Impella® 2.5 Catheter
Table 3.2 Impella® 2.5 Catheter Components
3.4
Component
Description
Pigtail
The 6 Fr pigtail is attached to the cannula at the distal end of the inlet area. It assists with stabilizing the catheter in the correct position in the left ventricle.
Inlet area
The inlet area, located at the distal tip of the cannula, has four openings (windows) that allow blood to be drawn into the inlet and channeled through the cannula.
Cannula
The 12 Fr cannula has a spiral-shaped reinforced body that is shaped in a 45-degree angle. The cannula is made of nitinol and covered in polyurethane.
Instructions for Use & Clinical Reference Manual (US)
Description
Outlet area
The proximal end of the cannula is attached to the outlet area where the blood exits the cannula.
Motor housing
The motor housing is 12 Fr in diameter and consists of an encapsulated motor.
Open pressure area
The open pressure area is an opening located between the motor housing and the distal end of the catheter shaft.
Catheter shaft
A 9 Fr catheter shaft is located between the motor housing and the red Impella® plug. The lumen of the catheter shaft contains a purge lumen, a pressure measurement lumen, and an electrical cable. The catheter shaft has longitudinal and transversal marks: • The longitudinal mark along the inner radius shows correct position of the 0.018 inch, 260 cm placement guidewire once backloaded on the Impella® 2.5 Catheter. • The transversal marks at 1 cm intervals with numbers every 5 cm aid in proper positioning.
Repositioning unit
The repositioning unit consists of a sheath and an anticontamination sleeve with an anchoring ring. • The sheath (with hemostatic valve) is graduated from 9 Fr to. 13 Fr. It is located on the catheter shaft and allows repositioning of the catheter. • The anchoring ring of the anticontamination sleeve secures the sheath to the catheter.
Red Impella® plug
The red Impella® plug at the proximal end of the catheter connects the catheter to the Impella® Console through a connector cable. It contains: • A pressure transducer that translates pressure for the pressure lumen proximal to the motor • Memory that retains operating parameters in case the patient needs to be transferred to another console • The placement signal lumen that allows for pressure and waveform displays It has two sidearms: a red pressure sidearm and a clear sidearm.
Red pressure sidearm
The red pressure sidearm is attached to a standard pressure bag and is used to prime the line of the pressure measurement system.
Clear sidearm
The clear sidearm is attached to the infusion pump to purge the Impella® 2.5 Catheter. It leads to the infusion filter, the pressure reservoir, and the check valve.
Infusion filter
The infusion filter prevents bacterial contamination and air from entering the purge lumen.
Pressure reservoir
The pressure reservoir includes a flexible rubber diaphragm that provides additional filling volume by means of an expansion chamber during purge solution change.
Check valve
The yellow check valve ensures that purge fluid does not flow in the reverse direction when the purge solution is exchanged.
Impella® 2.5 Catheter with Impella® Console
3 The Impella® 2.5 System
Component
Repositioning Sheath: Inner vs Outer Diameter The repositioning sheath has a graduated inner diameter of 9 Fr to 13 Fr. The outer diameter is graduated from 11 Fr to 15 Fr.
3.5
Impella® Console Impella® Console Battery Power The console can operate on its internal lithium-ion (Li-Ion) battery for at least 60 minutes when fully charged.
The Impella® Console (see Figure 3.5) controls the microaxial blood pump and monitors the Impella® 2.5 System. The console weighs 7 lbs (3.35 kg) and can operate on its internal battery for at least 60 minutes when fully charged. Impella® Console operation is described in detail in Section 4 of this manual.
Figure 3.5 Impella® Console
Impella® Power Supply and Power Supply Cable Impella® Power Supply The Impella® Power Supply (see Figures 3.6 and 3.7) provides power to and charges the battery within the Impella® Console. Data stored in the Impella® Console can be downloaded to a PC for analysis through the CAN-Bus interface located on the Impella® Power Supply. The Impella® Power Supply is a multivoltage AC power source for use with voltages within a range of 110 to 230 V at line frequencies of 50 and 60 Hz. The integrated charging circuit can fully charge the Li-Ion batteries in the Impella® Console in about 10 hours.
3.6
Instructions for Use & Clinical Reference Manual (US)
3 The Impella® 2.5 System
Figure 3.6 Impella® Power Supply
The front panel of the Impella® Power Supply has three green indicator lights: • POWER light – turns on when the unit is connected to AC power and powered on with the power switch on the rear panel. • CONNECTED light – turns on when the Impella® Console is connected to the Impella® Power Supply and the power supply is turned on. • CAN light – turns on when the Impella® Console is connected and powered on, but is not as bright as the other two lights; flickers briefly at the start of data transmission and when transmission has finished it flickers until the download program has finished or the CAN-bus connection is disconnected. CAN-Bus Interface (Service Use Only)
Impella® Console Connector
Fuses
AC Power Connector
Power Switch
Figure 3.7 Impella® Power Supply Rear Panel
The following items are located on the rear panel (see Figure 3.7) of the Impella® Power Supply: • CAN-Bus interface for data transfer to an external device • Impella® Console connector for cable to the Impella® Console • Fuses • AC power connector for AC power cable • Power switch (lights up when power is on)
Impella® 2.5 Catheter with Impella® Console
3.7