Impella® 5.0

Transcription

Impella® 5.0

Impella 5.0
®
with the Impella Console
®
Circulatory Support System
Instructions for Use
& Clinical Reference Manual
IMPORTANT NOTICE: Read this entire manual before using the Impella® 5.0 Circulatory Support System (Impella® 5.0 System).
The Impella® 5.0 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® 5.0
With the Impella® Console
Instructions for Use
& Clinical Reference Manual
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
June 2010
Document No. 0041-9006 Rev. A
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® 5.0 System
Overview.................................................................................................. 3.1
Impella® 5.0 Catheter............................................................................... 3.3
Impella® Console...................................................................................... 3.7
Impella® Power Supply and Power Supply Cable....................................... 3.8
Purge System............................................................................................ 3.10
Accessories............................................................................................... 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 Levels.................................................................... 4.6
Positioning Aids and Other Displays.......................................................... 4.7
Mobile Operation...................................................................................... 4.10
5 Using the Impella® 5.0 System
Startup...................................................................................................... 5.1
Preparing the Purge Fluid.......................................................................... 5.3
Preparing the Impella® 5.0 System............................................................ 5.4
Priming the Impella® 5.0 Catheter Purge Lumen....................................... 5.7
Inserting the Impella® 5.0 Catheter........................................................... 5.9
Positioning and Starting the Impella® 5.0 Catheter................................... 5.12
Replacing the Purge Tubing....................................................................... 5.14
Purge System Troubleshooting.................................................................. 5.15
Patient Weaning....................................................................................... 5.20
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® 5.0 Catheter...... 6.4
Understanding and Managing Impella® 5.0 Catheter Position Alarms....... 6.11
Suction..................................................................................................... 6.16
Hemolysis................................................................................................. 6.16
Pressure Sensor Drift and Sensor Failure................................................... 6.18
Operating the Impella® 5.0 Catheter Without Heparin in the
Purge Solution.......................................................................................... 6.20
How to Change to A Backup Console........................................................ 6.20
7 I mpella® Console Alarms and Warnings
Impella® 5.0 Console Alarms.................................................................... 7.1
Impella® 5.0 Console Warnings................................................................. 7.3
8 General System Information
Terminology, Abbreviations, and Symbols................................................. 8.1
Ambient Conditions.................................................................................. 8.3
Impella® 5.0 Catheter Parameters............................................................. 8.3
Impella® Console and Power Supply Parameters....................................... 8.4
Connector Cable Parameters..................................................................... 8.4
Impella® 5.0 Catheter Dimensions............................................................ 8.5
Anatomic Considerations.......................................................................... 8.6
Cleaning................................................................................................... 8.6
Storing the Impella® Console and the Power Supply.................................. 8.7
Returning an Impella® 5.0 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
Index
Table of Contents
Figures
Figure 3.1
Figure 3.2
Figure 3.3
Figure 3.4
Figure 3.5
Figure 3.6
Impella® 5.0 Catheter in the Heart............................................ 3.1
Impella® 5.0 System Components............................................. 3.2
Impella® 5.0 Catheter............................................................... 3.3
Differential Pressure Sensor...................................................... 3.5
Electrical Signal Generated by the Cardiac Cycle....................... 3.5
Correct Impella® 5.0 Catheter Positioning and Pulsatile
Placement Signal...................................................................... 3.6
Figure 3.7 Incorrect Impella® 5.0 Catheter Positioning and Flat
Placement Signal...................................................................... 3.6
Figure 3.8 Impella® Console...................................................................... 3.7
Figure 3.9 Impella® Power Supply.............................................................. 3.8
Figure 3.10 Impella® Power Supply Rear Panel............................................ 3.9
Figure 3.11 Impella® Power Supply Cable.................................................... 3.9
Figure 3.12 B. Braun Vista® basic Infusion Pump......................................... 3.10
Figure 3.13Impella® Combitrans-Monitoring Set (CM-Set).......................... 3.11
Figure 3.14 Pressure Transducer Cable........................................................ 3.11
Figure 3.15 Connector Cable....................................................................... 3.11
Figure 3.160.025 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 20% Dextrose in Water............................................................ 3.12
Figure 4.1 Impella® Console Function Keys................................................ 4.2
Figure 4.2 Impella® Console Display.......................................................... 4.5
Figure 4.3 Pulsatile Waveform on Placement Signal Screen....................... 4.7
Figure 4.4 Placement Monitoring Screen................................................... 4.7
Figure 4.5 Dual Signal Screen.................................................................... 4.8
Figure 4.6 Purge Pressure Screen............................................................... 4.8
Figure 4.7 Motor Current Screen............................................................... 4.9
Figure 4.8 Speed Screen............................................................................ 4.9
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 Connecting the Impella® 5.0 Catheter to the Connector
Cable........................................................................................ 5.4
Figure 5.6 Snapping Plastic Clip to Connector Cable.................................. 5.5
Figure 5.7 Attaching the Connector Cable to the Console......................... 5.5
Figure 5.8 Connect Pressure Transducer Cable Screen............................... 5.6
Figure 5.9 Connecting the Pressure Transducer Cable to the Console........ 5.6
Figure 5.10 Flush Purge Line and Purge Lumen Screen................................ 5.7
Figure 5.11 Connecting CM-Set to Impella® 5.0 Catheter............................ 5.7
Figure 5.12 Ready to Insert Screen.............................................................. 5.8
Figure 5.13 Discharging Fluid from Catheter Outlet Area............................. 5.8
Figure 5.14
Figure 5.15
Figure 5.16
Figure 5.17
Figure 5.18
Figure 5.19
Figure 5.20
Figure 5.21
Figure 5.22
Figure 5.23
Figure 5.24
Figure 5.25
Figure 6.1
Cut-Down Insertion of the Impella® 5.0 Catheter...................... 5.9
Guidewire Placement................................................................ 5.10
Initial Placement Signal............................................................. 5.12
Placement Signal as the Catheter Crosses the Aortic Valve....... 5.12
Confirming Placement on the Dual Signal Screen...................... 5.13
Low Purge Pressure Screen....................................................... 5.15
Normal Purge Pressure on 5 Minute Scale Screen..................... 5.16
Abnormal Purge Pressure on 5 Minute Scale Screen.................. 5.17
High Purge Pressure Screen...................................................... 5.18
Purge Management.................................................................. 5.19
Downstream Occlusion Alarm................................................... 5.20
Disconnecting the Connector Cable from the Console............... 5.21
Labeled TEE and TTE Images of the Impella® 5.0 Catheter
Position.................................................................................... 6.5
Figure 6.2 Transesophageal Echocardiographic (TEE) Illustrations of .
Impella® 5.0 Catheter Position.................................................. 6.8
Figure 6.3 Transthoracic Echocardiographic (TTE) Illustrations of .
Impella® 5.0 Catheter Position.................................................. 6.9
Figure 6.4 Correct and Incorrect Impella® 5.0 Catheter Position
(Color Doppler TTE).................................................................. 6.10
Figure 6.5 Correct Impella® 5.0 Catheter Position..................................... 6.12
Figure 6.6 Impella® 5.0 Catheter Fully in Ventricle or Fully in Aorta........... 6.13
Figure 6.7 Impella® 5.0 Catheter Position Unknown Due to Low
Pulsatility.................................................................................. 6.14
Figure 6.8 Impella® 5.0 Catheter Outlet Area on or near Aortic Valve........ 6.15
Figure 8.1 Impella® 5.0 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
Tables
Table 3.1
Table 3.2
Table 4.1
Table 4.2
Table 4.3
Table 4.4
Table 5.1
Table 5.2
Table 5.3
Table 6.1
Table 6.2
Impella® 5.0 Catheter Components.......................................... 3.3
Impella® 5.0 System Accessories............................................... 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........................................ 5.16
Amount of Dextrose Delivered in the Purge Fluid (g/h).............. 5.19
Amount of Heparin Delivered in the Purge Fluid (IU/h).............. 5.19
Guide for Managing Hemolysis in Various Circumstances.......... 6.17
Expected Flow Rate Displayed on Console................................ 6.18
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® 5.0 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® 5.0 System may be used only for its intended purpose.
Manual Overview
This manual provides instructions for use of the Impella® 5.0 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® 5.0 System.
• Section 2: Indications, Contraindications, and Potential Adverse Events
discusses indications for use of the Impella® 5.0 System, contraindications, and potential
adverse events that may be associated with use of the system.
• Section 3: The Impella® 5.0 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® 5.0 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® 5.0 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® 5.0 System components and packaging, technical information
pertaining to the Impella® 5.0 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 and technical safety inspection,
maintenance and repair.
Impella® 5.0 with the Impella® Console
I
1 Warnings and Cautions
Warnings.................................................................................................... 1.1
Cautions.....................................................................................................1.2
Warnings
Warnings
The Impella® 5.0 System has not been qualified in the United States (US) through
clinical studies for long term use (longer than 6 hours), for example, as a bridge to
transplant or for pending recovery of the natural heart.
Warnings alert you to
situations that can cause
death or serious injury. The
red symbol
appears before
warning messages.
Fluoroscopy is required to guide placement of the Impella® 5.0 Catheter. The small
placement guidewire must be reliably observed at all times.
Avoid manual compression of the inlet, outlet, or sensor areas of the cannula
assembly.
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® 5.0 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 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® 5.0 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® 5.0 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® 5.0 Catheter is set
at performance level P0.
The infusion pump supplied 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® 5.0 System if any part of the system is damaged.
To prevent the risk of explosion, do NOT operate the Impella® 5.0 System near
flammable anesthetics.
If at any time during the course of support with the Impella® 5.0 Catheter, the
Impella® Console alarms “Low Purge Pressure,” follow the instructions presented in
“Purge System Troubleshooting” in Section 5 of this manual.
1.1
1 WARNINGS AND CAUTIONS
The Impella® 5.0 System is intended for use only by personnel trained in accordance
with the Abiomed® Training Program.
Do NOT subject a patient who has been implanted with an Impella® 5.0 Catheter
to magnetic resonance imaging (MRI). The strong magnetic energy produced by
an MRI machine may cause the Impella® 5.0 System components to stop working,
and result in injuries to the patient. An MRI may also damage the electronics of the
Impella® 5.0 System.
During defibrillation, do NOT touch the Impella® 5.0 Catheter, cables, or Impella®
Console.
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® 5.0 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® 5.0 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® 5.0 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.
The performance level of the Impella® 5.0 Catheter is automatically set to P2 during
zeroing if the catheter is operating above P0. Performance level remains at P2 after
zeroing and does not automatically return to its prior setting.
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® 5.0 Catheter until the
placement guidewire has been removed.
Do NOT remove the Impella® 5.0 Catheter over the length of the placement
guidewire.
1.2
Instructions for Use & Clinical Reference Manual
1 WARNINGS AND CAUTIONS
When replacing the purge tubing, the replacement process must be completed
within 2 minutes. The Impella® 5.0 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® 5.0 Catheter.
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.
Do NOT use cell phones within a radius of 1 meter (3.28 feet) of the Impella® 5.0
System. Cell phones can cause improper operation of the system and endanger the
patient.
Minimize exposure of Impella® 5.0 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® 5.0 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®
5.0 Catheter.
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® 5.0 is intended for circulatory support using an extracorporeal bypass control
unit, for periods up to 6 hours. It is also intended to be used to provide circulatory support (for
periods up to 6 hours) during procedures not requiring cardiopulmonary bypass.
The Impella® 5.0 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® 5.0 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® 5.0 device
placement
Potential Adverse Events (United States)
• Aortic insufficiency
• Limb ischemia
• Aortic valve injury
• Myocardial infarction
• Arrhythmia
• Neurologic injury
• Atrial fibrillation
• Perforation
• Bleeding
• Renal failure
• Cardiac tamponade
• Respiratory dysfunction
• Cardiogenic shock
• Sepsis
• Cerebral vascular accident
• Thrombocytopenia
• Death
• Thrombotic vascular (non-CNS) complication
• Device malfunction
• Transient ischemic attack (TIA)
• Hemolysis
• Vascular injury
• Hepatic failure
• Ventricular fibrillation
• Insertion site infection
• Ventricular tachycardia
2.1
3 The Impella® 5.0 System
Overview.....................................................................................................3.1
Reusable System Components.......................................................................... 3.1
Single-use System Components........................................................................3.2
System Configuration.......................................................................................3.2
Impella® 5.0 Catheter.............................................................................. 3.3
Catheter Components.......................................................................................3.3
Differential Pressure Sensor..............................................................................3.4
Impella® Console......................................................................................3.7
Impella® Power Supply and Power Supply Cable..............................3.8
Impella® Power Supply.....................................................................................3.8
Impella® Power Supply Cable............................................................................3.9
Purge System...........................................................................................3.10
Accessories.............................................................................................. 3.11
Overview
3The Impella® 5.0 System
The Impella® 5.0 Catheter is an intravascular microaxial blood pump that supports a patient’s
circulatory system. The catheter is inserted through the femoral artery and into the left ventricle.
(See Figure 3.1.)
Figure 3.1 Impella® 5.0 Catheter in the Heart
When properly positioned, the Impella® 5.0 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®
5.0 Catheter on the display screen of the Impella® Console.
This section describes the components of the Impella® 5.0 System.
Reusable System Components
The Impella® 5.0 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® 5.0 Catheter
• Pressure transducer cable
• Pump test plug
3.1
Single-use System Components
The system also includes the following single-use components:
• Impella® 5.0 Catheter
• Impella® Combitrans-Monitoring Set (CM-Set)
• 0.025 inch, 260 cm placement guidewire
• Connector cable
• Purge tubing
System Configuration
Figure 3.2 illustrates the Impella® 5.0 System components.
D20
Dextrose
Solution
Power Supply
Power Supply Cable
Infusion
Pump
Pressure
Transducer
Cable
Impella® 5.0 Catheter
Impella® Console
Connector Cable
Purge Tubing
Combitrans-Monitoring Set
= connection
Figure 3.2 Impella® 5.0 System Components
3.2
Catheter Components
The Impella® 5.0 Catheter is an intravascular microaxial blood pump that delivers up to 5.0 liters
of blood per minute from the left ventricle into the aorta. Figure 3.3 illustrates the Impella® 5.0
Catheter. Table 3.1 describes each component from the pigtail at one end to the check valve on
the other end.
Check Valve
Pressure Reservoir
Red
Impella®
Plug
Infusion Filter
Clear Sidearm
Catheter Shaft
Repositioning
Unit
Pigtail
Inlet Area
Cannula
Differential
Pressure
Sensor
Outlet
Area
Motor
Housing
Figure 3.3 Impella® 5.0 Catheter
Table 3.1 Impella® 5.0 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 and decreases the amount of ectopy that could be
caused by a foreign body in the ventricle.
Inlet area
The inlet area, located at the distal tip of the cannula, has five
openings (windows) that allow blood to be drawn into the inlet and
channeled through the cannula.
Cannula
The 21 Fr cannula has a spiral-shaped reinforced body that is shaped
in a 35-degree angle. The cannula is made of nitinol and covered in
polyurethane.
• Nitinol provides the cannula with flexibility and memory, allowing it
to conform across the aortic valve.
• Polyurethane provides a smooth surface for atraumatic positioning
and reduced risk of damage to the aortic valve.
3.3
Table 3.1 Impella® 5.0 Catheter Components (cont’d)
Component
Description
Differential pressure
sensor
A sensor that measures the pressure difference between the inside
and outside of the cannula. The pressure value is used for positioning
during placement and for monitoring flow and position during catheter
operation.
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 21 Fr in diameter and consists of an encapsulated
motor.
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, an electrical cable, and a differential pressure
measurement cable.
The catheter shaft has longitudinal and transversal marks:
• The longitudinal mark along the inner radius shows correct position
of the 0.025 inch, 260 cm placement guidewire once backloaded on
the Impella® 5.0 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 9 Fr sheath (11 Fr outer diameter) with hemostatic valve is
located on the catheter shaft and allows repositioning of the
catheter.
• The anchoring ring of the anticontamination sleeve secures the
sheath to the catheter.
Red Impella® plug
The red Impella® plug has a clear sidearm and contains memory
that retains operating parameters in case the patient needs to be
transferred to another console. The plug connects the catheter to the
Impella® Console through a connector cable.
Clear sidearm
The clear sidearm is attached to the infusion pump to purge the
Impella® 5.0 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.
Differential Pressure Sensor
The Impella® 5.0 Catheter has an electronic differential pressure sensor located at the proximal
end of the 21 Fr cannula (see Figure 3.4). The purpose of the pressure sensor is to generate the
placement signal, which is used by operators, the console’s placement monitoring screen, and
alarm algorithms to monitor the position of the Impella® 5.0 cannula relative to the aortic valve.
3.4
The pressure sensor is a flexible membrane integrated into the cannula (see Figure 3.4). One side
of the sensor is exposed to the blood pressure on the outside of the cannula and the other side
is exposed to the pressure of the blood inside of the cannula. The sensor generates an electrical
signal proportional to the difference between the pressure outside the cannula and the pressure
inside. This signal is displayed on the Impella® Console as the placement signal.
Differential
Pressure Sensor
Aortic Pressure
Sensor
Flow from
Ventricle
Ventricular
Pressure
Flow to
Aorta
Membrane
Cannula
Aortic Valve
Figure 3.4 Differential Pressure Sensor
The pressure sensor membrane flexes when the pressure on one side is different from the
pressure on the other side, and the electrical properties of the membrane change when it flexes.
This allows the sensor to generate an electrical signal proportional to how much the membrane
is flexed, and thus proportional to the difference between the pressure on the outside of the
cannula and the pressure inside. When the Impella® 5.0 Catheter is placed in the correct position
across the aortic valve, the top (outer surface) of the sensor is exposed to the aortic pressure and
the bottom (inner surface) of the sensor is exposed to the ventricular pressure. Therefore, the
placement signal is approximately equal to the difference between the aortic pressure and the
ventricular pressure (see Figure 3.5).
Systole
Blood Pressure (mmHg)
120
Aortic pressure
80
Pressure
difference
Diastole
Left ventricular
pressure
0
Time
PDifferential = PAO - PLV
Pressure difference (PDifferential )
Left ventricular pressure (PLV )
Aortic pressure (PAO )
Figure 3.5 Electrical Signal Generated by the Cardiac Cycle
3.5
When the Impella® 5.0 Catheter is correctly positioned across the aortic valve, the changes in
pressure associated with the cardiac cycle result in a pulsatile placement signal (see Figure 3.6).
During diastole (time zero in Figure 3.5), the large pressure difference between the aorta and the
left ventricle creates a large electrical signal. Then at the peak of systole, when the aortic valve
opens, the pressure difference between the aorta and the left ventricle—and thus the electrical
signal—is zero. Thus, the continual pressure changes associated with the cardiac cycle produce
the pulsatile (up and down) waveform seen on the Impella® Console display.
P-Perf
Flow [L/min]
P9
5.0
98%
LV4509
35
1
Placement Monitoring
Ventricle
P-Perf
P9
LV4509
Flow [L/min]
5.0
98%
35
1
Placement Signal [mmHg]
Aorta
Pump Position OK
10 s
10 s
Impella® 5.0 Catheter correctly positioned
Pulsatile placement signal
Figure 3.6 Correct Impella® 5.0 Catheter Positioning and Pulsatile Placement Signal
When the Impella® 5.0 Catheter is not properly placed across the aortic valve, or when it is fully
in the aorta or fully in the ventricle, the pressures outside and inside the cannula are the same
throughout the cardiac cycle. As a result, the pressure on either side of the sensor membrane is
the same, resulting in a flat placement signal (see Figure 3.7).
P8
98%
Ventricle
Aorta
2.5
LV4509
P-Perf
Flow [L/min]
Pump Position Wrong
98%
Ventricle
Aorta
P8
2.5
Press MENU for Reposition
P-Perf
P9
LV4509
Flow [L/min]
98%
5.3
8
-2
10 s
LV4509
Pump Position Wrong
Ventricle
Aorta
10 s
10 s
Impella® 5.0 Catheter position incorrect
Flattened placement signal
Figure 3.7 Incorrect Impella® 5.0 Catheter Positioning and Flat Placement Signal
3.6
Impella® Console
Impella® Console operation is described in detail in Section 4 of this manual.
Impella® Console Battery
Power
The console can operate
on its internal lithium-ion
(Li-Ion) battery for at least 60
minutes when fully charged.
Figure 3.8 Impella® Console
3.7
The Impella® Console (see Figure 3.8) controls the microaxial blood pump and monitors the
Impella® 5.0 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® Power Supply and Power Supply Cable
Impella® Power Supply
The Impella® Power Supply (see Figures 3.9 and 3.10) 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.
Figure 3.9 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.
3.8
Impella®
Console
Connector
Fuses
AC Power
Connector
CAN-Bus Interface
(Service Use Only)
Power Switch
Figure 3.10 Impella® Power Supply Rear Panel
The following items are located on the rear panel (see Figure 3.10) 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® Power Supply Cable
The Impella® Power Supply cable (see Figure 3.11) connects the Impella® Power Supply to the
Impella® Console.
Figure 3.11 Impella® Power Supply Cable
3.9
Purge System
Do not use saline in the purge system.
Refer to Infusion pump
IFU
For more information about
the infusion pump being
used, refer to the instructions
for use included with the
infusion pump.
The Impella® 5.0 System requires a purge system that delivers rinsing fluid to the Impella® 5.0
Catheter. The B. Braun Vista basic Infusion Pump (see Figure 3.12) is an example of an infusion
pump Abiomed uses to serve this function. It delivers purge fluid (typically 20% dextrose
solution plus heparin 50 IU/mL) through the catheter to the microaxial blood pump to prevent
blood from entering the motor.
Display
Screen
Function Keys
ON/OFF Key
Keypad
Alarm Silence Key
START/STOP Key
Alarm Light
Clear Key
Infusion Light
Figure 3.12 B. Braun Vista® basic Infusion Pump
• Display screen – for communicating information; green backlighting turns on when the
unit is connected to AC power; in battery operation, the backlighting turns on when a key
is pressed
• Keypad – for entering infusion settings
• Alarm light – for alerting users to an alarm; turns on when an alarm condition occurs;
display flashes “AAA.A”
• Infusion light – for alerting users that the pump is infusing
• Function keys – for selecting on-screen options
• ON/OFF key – for turning the Vista basic power on and off
• Alarm silence key – for silencing the alarm for approximately 2 minutes
• START/STOP key – for starting and stopping the infusion
• Clear key – for resetting a value to zero
3.10
Accessories
Table 3.2 illustrates and describes the Impella® 5.0 System accessories.
Table 3.2 Impella® 5.0 System Accessories
Component
Description
The CM-Set is connected to the purge tubing and
to the yellow check valve on the clear sidearm of
the Impella® 5.0 Catheter. The CM-Set measures
the purge pressure in the purge lumen of the
catheter. The purge pressure measurement is
displayed on the Impella® Console and must be
within the range of 300 to 700 mmHg.
The CM-Set is connected to the Impella® Console
with the pressure transducer cable.
Figure 3.13 Impella® CombitransMonitoring Set (CM-Set)
The gray pressure transducer cable connects the
CM-Set to the Impella® Console. The cable is
reusable and nonsterile.
• The yellow plug at the end of the cable is
inserted into the pressure connector socket on
the left side of the Impella® Console. Earlier
versions of the cable have a red hub at the end
that plugs into the console.
• The plug at the opposite end is connected to the
CM-Set.
Figure 3.14 Pressure Transducer Cable
The blue, disposable connector cable connects the
catheter to the Impella® Console.
• The socket at the gray end of the cable connects
to the red Impella® plug.
• The blue plug at the opposite end of the cable
is inserted into the catheter connector socket on
the right side of the Impella® Console. A retainer
at the end of the connector cable prevents
inadvertent removal of the cable from the
Impella® Console.
Figure 3.15 Connector Cable
3.11
Component
Description
The 0.025 inch, 260 cm guidewire is used for the
placement of the Impella® 5.0 Catheter only.
Figure 3.16 0
.025 inch, 260 cm
Placement Guidewire
The purge tubing connects to the CM-Set, which
connects to the yellow check valve on the clear
sidearm of the Impella® 5.0 Catheter. Purge tubing
for the B. Braun Vista basic Infusion Pump is
shown here.
Figure 3.17 Purge Tubing
The pump test plug is a test device used only
for preventive maintenance to confirm Impella®
Console function.
Figure 3.18 Pump Test Plug
Hospital Provided:
Dextrose solution (typically 20% dextrose in water
with 50 IU/mL of heparin) is used as the purge
fluid through the Impella® 5.0 Catheter.
Figure 3.19 20% Dextrose in Water
3.12
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 Levels..............................................................4.6
Positioning Aids and Other Displays...................................................4.7
Placement Signal (mmHg)................................................................................. 4.7
Placement Monitoring...................................................................................... 4.7
Dual Signal.......................................................................................................4.8
Purge Pressure..................................................................................................4.8
Motor Current (A).............................................................................................4.9
Speed...............................................................................................................4.9
Flow Rate....................................................................................................... 4.10
Mobile Operation....................................................................................4.10
Overview
4Using the Impella® Console
The Impella® Console is the primary user control interface for the Impella® 5.0 System. It controls
the Impella® 5.0 Catheter performance, monitors the Impella® 5.0 System for alarms, and
provides real time catheter position information regarding the location of the catheter across
the aortic valve. The console can be powered by the Impella® Power Supply or can operate on
internal battery power for at least 60 minutes when fully charged.
This section of the manual discusses:
• Console function keys
• Console connections
• Console display
• Performance levels (P0-P9)
• Positioning aids and other displays
• Mobile operation of the console
4.1
Impella® Console Function Keys
Figure 4.1 illustrates the function keys on the Impella® Console. These keys are described
in Table 4.1.
Display Screen
P-PERF Key
ZERO Key
Power Supply Connector
FLOW Key
(not active)
SIGNAL Key
MENU Key
▼/▲ Keys
SCALE Key
ON Key
OK Key
Pressure
Connector
Socket
Catheter
Connector
Socket
Figure 4.1 Impella® Console Function Keys
4.2
Table 4.1 Impella® Console Function Keys
Description
P-PERF key
Change the performance level of the Impella® 5.0 Catheter (P0 to P9)
ZERO key
Used to zero the differential pressure sensor (described in section 6 of this
manual)
MENU key
Access functions that differ depending on whether the catheter is connected.
Functions with the catheter connected:
Flow Monitoring
• Active when the adjusted flow limit appears to the left of the numeric
flow value
• Bell symbol crossed out when warning is muted
Low Flow Limit*
• Set default limit to approximately 0.3 L/min below currently displayed
mean flow
• Change limit in 0.1 L/min steps
• Turn off flow limit monitoring
MENU key
The MENU key on the console
accesses different functions
depending on whether the
catheter is connected (see
Table).
*NOTE: A warning is generated if values fall below the low flow limit
Information
• Query information about catheter type, catheter ID, Impella® Console
software version, and catheter operating hours
Repositioning Guide
• Display recommended steps for repositioning the catheter
Disable Placement Monitoring
• Disable the placement monitoring function; should be used only with the
assistance of a trained Abiomed representative
Enable Placement Monitoring
• Enable disabled placement monitoring
Functions without the catheter connected:
Language—select English, German, French, Spanish, or Italian
Switch off console
Console Information
▼ and ▲ keys
• Decrease or increase selected parameters
• Select a menu item
OK key
Acknowledge an entry value or command
FLOW key
Not active
SIGNAL key
View the following screens:
• Placement signal (mmHg)
• Placement monitoring
• Dual signal (motor current and placement signal)
• Purge pressure (mmHg)
• Motor current (A)
• Speed (rpm x 1000)
• Flow rate (L/min)
4.3
Key
Table 4.1 Impella® Console Function Keys (cont’d)
Key
Description
SCALE key
Select one of three time windows:
• 10 seconds
• 5 minutes
• 5 hours
The corresponding value is displayed under the bar graph on the right side .
of the display. Minimum and maximum values appear above the axis.
ON key
Power up the Impella® Console when not connected to the Impella® Power
Supply.
To turn the Impella® Console ON:
(1) Press and hold ON for 3 seconds*
To turn the Impella® Console OFF:
(1) Press the MENU key
(2) Select “Switch Off Console”
(3) Press OK
OR
Disconnect the catheter from the Impella® Console and the console will
turn off automatically after 10 minutes
*NOTE: Holding down the ON key for longer than 3 seconds during operation will cause the
console to go into emergency stop mode
Impella® Console Connections
Table 4.2 describes the three connection locations on the Impella® Console (illustrated in
Figure 4.1).
Table 4.2 Impella® Console Connections
4.4
Connector name
Description
Power supply connector
(Top of console)
Connection for the power supply cable that connects the Impella®
Console to the Impella® Power Supply and carries console data to
the CAN-Bus interface located on the Impella® Power Supply
Pressure connector socket
(Left side of console; yellow)
Socket for the gray pressure transducer cable that connects the
console to the CM-Set
Catheter connector socket
(Right side of console; blue)
Socket for the connector cable that connects the console to the red
Impella® plug on the catheter
Also used to connect the pump test plug to confirm console function
during preventive maintenance
Impella® Console Display
The elements of the Impella® Console display are shown in Figure 4.2 and described
in Table 4.3.
Performance
Level
AC Power
Icon
Battery
Status
P-Perf
P9
LV4509
Catheter Operation
Icon
Low Flow Alarm
Limit Icon
Flow [L/min]
5.0
98%
35
1
Dual Signal
I
Flow Rate
Type of Signal Selected
Signal Numeric Readout
Signal Bar Graph
P
10 s
Catheter Type and
Serial Number
Time Window Display
Information and
Waveform Display
Figure 4.2 Impella® Console Display
Table 4.3 Impella® Console Display Elements
Display Element
Description
Performance level
Indicates the performance level (P0 to P9) at which the catheter is
operating
AC power icon
Appears when the Impella® Console is connected to the Impella®
Power Supply
Battery status information
Bar graph and numeric readout (percentage); shows the
approximate battery charge level
• During battery operation, the bar graph flashes when the
charge level is less than 50%
• When the battery is charging, the bar graph flashes between
the present charge level and 100%
Catheter operation icon
Rotates when the Impella® 5.0 Catheter is operating
Low flow alarm limit icon
Indicates whether the alarm is enabled or disabled
• Enabled: bell symbol and numeric alarm limit are displayed
• Disabled: bell symbol is crossed out (as shown in Figure 4.2)
Flow rate
Indicates the calculated flow rate through the Impella® 5.0
Catheter cannula (0 to 5.0 L/min)
Type of signal selected
Displays the title of the signal being shown
4.5
Table 4.3 Impella® Console Display Elements (cont’d)
Display Element
Description
Signal numeric readout
Displays the maximum and minimum values or a numeric mean
value for the selected signal; numeric maximum and minimum
values displayed on the dual signal and placement monitoring
screens correspond to the placement signal
Signal bar graph
Corresponds to the selected signal screen displayed and its value
Time window display
Indicates the type of window displayed (10 seconds, 5 minutes, or
5 hours)
Information and waveform
display
Shows information during the startup procedure; shows
waveforms during catheter operation
Catheter type and serial
number
Indicates the catheter type; also displays the catheter serial
number
Selecting Performance Levels
Retrograde flow
A setting of P0 will result
in retrograde flow when
the Impella® 5.0 Catheter is
placed across the aortic valve.
Retrograde flow may also
occur at P1.
Ten different performance levels (P0 to P9) can be selected (see Table 4.4). Select the lowest
performance level that will enable you to achieve the flow rate necessary for patient support.
Table 4.4 Performance Level Flow Rates
*Flow Rate
(L/min)
Revolutions Per Minute
(rpm)
P0
0.0 – 0.0
0
P1
0.0 – 1.4
10,000
P2
0.5 – 2.6
17,000
P3
0.5 – 3.1
20,000
P4
0.9 – 3.4
22,000
Performance Level
P5
1.4 – 3.7
24,000
P6
1.8 – 4.0
26,000
P7
2.6 – 4.4
28,000
P8
3.4 – 4.7
30,000
P9
4.2 – 5.3
33,000
*Flow rate can vary due to suction or incorrect positioning.
Acknowledging
Performance Level
Selection
The performance level
selection will be canceled if
you do not press OK within
10 seconds of selecting the
performance level.
4.6
To select a performance level:
1.Press and hold the P-PERF key until two blinking vertical bar graphs appear next to
the performance level display (P0 to P9).
2.Select the performance level by pressing ▲ to increase performance level or ▼ to
decrease performance level.
3.Press OK within 10 seconds to set the performance level to the level selected.
Positioning Aids and Other Displays
Placement Signal (mmHg)
The placement signal screen (see Figure 4.3) shows a pressure measurement that is useful for
determining the location of the differential pressure sensor with respect to the aortic valve. The
placement signal is used to verify the position of the microaxial blood pump by evaluating the
differential pressure as pulsatile or flattened.
P-Perf
P9
LV4509
Flow [L/min]
5.0
98%
35
1
10 s
Figure 4.3 Pulsatile Waveform on Placement Signal Screen
The placement monitoring screen (see Figure 4.4) shows the approximate catheter position.
P-Perf
P9
LV4509
Ventricle
Flow [L/min]
5.0
98%
35
1
Aorta
The placement monitoring
screen will display “Disabled
Due to Low Performance
Level” if catheter performance
level is less than P1. If there is
a problem with the pressure
sensor, it will display “Disabled
Due to Non Reliable Sensor.”
Pump Position OK
Delayed Response
10 s
Figure 4.4 Placement Monitoring Screen
It may take several seconds
for the graphic on the screen
to show changes in catheter
position.
4.7
Dual Signal
The dual signal screen (see Figure 4.5) shows the motor current and placement signal waveforms
simultaneously. The motor current is the upper waveform.
P-Perf
P9
LV4509
Flow [L/min]
5.0
98%
35
2
Dual Signal
Motor
current
(amps)
Placement
signal
(mmHg)
I
Differential
pressure
(mmHg)
P
Position of
bar graph
corresponds
to placement
signal
10 s
Figure 4.5 Dual Signal Screen
Purge Pressure
The Impella® Console monitors purge pressure, the pressure of the purge fluid delivered through
the catheter to the motor. The purge pressure display ranges from 0 to 1000 mmHg. A warning
appears if purge pressure falls below 300 mmHg or exceeds 700 mmHg.
P-Perf
P9
LV4509
Flow [L/min]
98%
5.0
Purge Pressure [mmHg]
472
<
<
10 s
Figure 4.6 Purge Pressure Screen
4.8
Motor Current (A)
Motor current is a measure of the energy intake of the Impella® 5.0 Catheter motor. The energy
intake varies with motor speed and the pressure difference between the inlet and outlet areas of
the cannula. It is important to monitor the motor current waveform (see Figure 4.7) because it
provides information about the catheter position relative to the aortic valve. When the Impella®
5.0 Catheter is positioned correctly, with the inlet area in the ventricle and the outlet area in the
aorta, the motor current is pulsatile because the pressure difference between the inlet and outlet
areas changes with the cardiac cycle. When the inlet and outlet areas are on the same side of
the aortic valve, the motor current will be dampened or flat because there is little or no pressure
difference between the inlet and outlet areas.
Flow [L/min]
P-Perf
P9
LV4509
98%
5.0
0.74
0.64
Motor Current [A]
10 s
Figure 4.7 Motor Current Screen
Speed
The speed screen (see Figure 4.8) shows the actual rotational speed of the Impella® 5.0 Catheter
motor, located on the distal portion of the catheter. Speed ranges between 0 and 33,000 rpm.
P-Perf
P9
LV4509
Flow [L/min]
98%
Speed [rpm x 1000]
5.0
33.0
10 s
Figure 4.8 Speed Screen
4.9
Flow Rate
Flow rate is representative of the Impella® 5.0 Catheter output measured in liters per minute.
It is calculated using the rotational speed (as set by the performance level) and the differential
pressure (placement signal). Flow rate ranges between 0 and 5.3 L/min.
P-Perf
P9
LV4509
Flow [L/min]
98%
5.0
5.3
4.5
Flow [L/min]
10 s
Figure 4.9 Flow Rate Screen
Mobile Operation
Turning Console On in
Mobile Operation
If it is necessary to turn the
Impella® Console on under
mobile operation, the
ON key must be held for
3 seconds to power up the
Impella® Console.
4.10
The Impella® Console can be operated on internal battery power when it is not connected to the
Impella® Power Supply:
1.Disconnect the Impella® Console from the Impella® Power Supply by disconnecting the
power supply cable from the top of the Impella® Console.
2.The Impella® Console beeps once to alert you that the Impella® Console is on battery
power. The AC power icon to the left of the battery icon disappears.
3.When connected back to the Impella® Power Supply, the Impella® Console beeps once
to alert you that the Impella® Console is on main power and the AC power icon returns.
Startup........................................................................................................5.1
Supplies Needed............................................................................................... 5.1
Equipment Set-up............................................................................................. 5.1
Preparing the Purge Fluid......................................................................5.3
Preparing the Impella® 5.0 System.......................................................5.4
Connecting the Impella® 5.0 Catheter and Connector Cable.............................5.4
Connecting the Pressure Transducer Cable........................................................5.6
Priming the Impella® 5.0 Catheter Purge Lumen...............................5.7
Inserting the Impella® 5.0 Catheter....................................................5.9
Positioning and Starting the Impella® 5.0 Catheter..................... 5.12
Replacing the Purge Tubing................................................................. 5.14
Purge System Troubleshooting.......................................................... 5.15
Low Purge Pressure........................................................................................ 5.15
High Purge Pressure....................................................................................... 5.18
Purge Pressure Management Strategies.......................................................... 5.19
Downstream Occlusion...................................................................................5.20
Patient Weaning......................................................................................5.20
Rapid Weaning...............................................................................................5.20
Slow Weaning................................................................................................ 5.21
1
Startup
Do NOT use an Impella® 5.0 System if any part of the system is damaged.
Do NOT resterilize or reuse the Impella® 5.0 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.
Protect the Impella® 5.0 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.
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.
Supplies Needed
• Impella® 5.0 System (Impella® 5.0 Catheter, accessories, and Impella® Console)
• 500 cc bag of dextrose solution for purge solution (20% recommended; 5% to 40%
acceptable) with 50 IU heparin/mL
Equipment Set-up
Before starting the Impella® Console, check that the rechargeable batteries are fully charged.
Have a backup console available in the unlikely event of console failure.
1.Place the Impella® Power Supply and the Impella® Console next to each other on a
horizontal surface or on the optional Impella® Console cart.
Figure 5.1 Placing the Impella® Power Supply Next to the Impella® Console
2.Connect the power cord to the AC power connector on the rear panel of the Impella®
Power Supply and to an AC outlet.
5.1
3.Connect the Impella® Power Supply cable to the Impella® Console connector on the
rear panel of the Impella® Power Supply (see Figure 5.2).
Figure 5.2 Connecting the Power Supply Cable to the Power Supply
4.Connect the Impella® Console to the Impella® Power Supply with the power supply
cable (see Figure 5.3). Avoid overtightening the screw.
Figure 5.3 Connecting the Power Supply Cable to the Console
If CONNECTED Light
Not On
If the CONNECTED light is not
on, turn the Impella® Power
Supply off and on. If this does
not solve the problem, turn
the Impella® Power Supply
off and on again. Do not use
the Impella® Console if the
CONNECTED light is not on
after two attempts.
5.Turn on the Impella® Power Supply using the power switch located on the rear panel of
the power supply. The Impella® Console is powered up automatically when the Impella®
Power Supply is turned on.
Power switch
Figure 5.4 Turning the Power Supply On
6.Make sure that the Impella® Power Supply is functioning properly by checking for all of
the following conditions:
• ON/OFF switch is illuminated.
• Impella® Power Supply fan is running.
• Green POWER and CONNECTED lights on the Impella® Power Supply are on.
• AC power icon appears on the Impella® Console display.
5.2
Preparing the Purge Fluid
Shaded Steps
All shaded steps require sterile
technique.
1.Connect the infusion pump to an AC outlet.
2.Turn the infusion pump on.
3.Add heparin to achieve 50 IU heparin/mL in 20% dextrose solution.
4.Connect the purge tubing to the 20% dextrose solution.
5.Flush the purge tubing manually and close the roller clamp.
6.Using sterile technique, open the Impella® Combitrans-Monitoring Set (CM-Set) and
secure the male luerlock to the sterile field.
7.Hand the CM-Set’s green pressure transducer off the sterile field and connect it to the
purge tubing. Flush the CM-Set using one of the following methods:
a.Manual flush: Open the roller clamp and apply manual pressure to the purge
solution bag until fluid exits the distal end of the purge tubing and the tubing is
flushed of air. Close the roller clamp. Proceed to Step 8.
b.Alternative flush: After attaching the CM-Set to the infusion set, perform Steps
8–12 as shown below. Press Start/Stop to start the infusion. Then press and hold
the “Bolus” soft button. A second “Bolus” soft button will be displayed. Press and
hold the two “Bolus” soft buttons until the CM-Set is flushed. Press Start/Stop to
stop the infusion.
Turning on the Infusion
Pump
Do NOT turn on the infusion
pump with the purge tubing
in place. This will cause the
downstream occlusion sensor
to be miscalibrated, leading to
false alarms.
8.Open the infusion pump door by pressing the Door Open button at the top right
corner. Push and hold open the clamp at the top of the fluid path.
9.Insert the purge tubing into the clamp and release it. Thread the tubing down the fluid
path, making sure the tubing is pressed into the Air-in-Line detector at the bottom of
the fluid path. Close the door and open the roller clamp.
10.The infusion pump displays “Is This a New Therapy?” Press the YES key to confirm.
11.The infusion pump displays “Enter Infusion Rate.” Enter a rate of 7 mL/h.
12.Press VTBD (Volume To Be Delivered) and enter the volume (in mL) at which the
infusion pump should alarm, indicating the need to replace the purge fluid bag. .
Press OK.
Note for Vista basic
Users
If you are using the B. Braun
Vista basic Infusion Pump and
it has been used for a prior
infusion, it will ask if you want
to continue with prior therapy
after you connect the purge
tubing. Press NO.
5.3
Refer to the instructions for use supplied with the infusion pump being used
before using the infusion pump with the Impella® 5.0 System.
Preparing the Impella® 5.0 System
assembly.
guidewire.
Handle with care. The Impella® 5.0 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.
Protect the Clear
Sidearm and Catheter
The clear sidearm of the
between the pressure
reservoir and red Impella®
plug can become kinked.
Support the pressure reservoir
and the length of the catheter
as you remove the Impella®
5.0 Catheter from the tray.
Avoid allowing the pressure
reservoir to hang freely from
the red Impella® plug and
avoid bending the catheter
near the red Impella® plug.
Sensitive Medical Device
The Impella® 5.0 Catheter is a
sensitive medical device with
extremely fine tolerances. In
particular, the inlet and outlet
areas of the catheter assembly
may be damaged if subjected
to strong external forces.
5.4
Connecting the Impella® 5.0 Catheter and Connector Cable
1. S lowly open the package and carefully remove the Impella® 5.0 Catheter using sterile
technique. Inspect the catheter, including its connector, for damage.
2.Remove the connector cable from its package using sterile technique. Inspect the cable
for damage, including damage to the connector pins at the console end.
3.Secure the black end of the cable to the sterile field.
4. Insert the catheter plug into the connector cable socket (black end). The tab and the
slot must be aligned during connection (see Figure 5.5).
Catheter Plug
Connector
Cable Socket
(black end)
Figure 5.5 Connecting the Impella® 5.0 Catheter to the Connector Cable
5.Pull back on the connection to make sure that the plug has snapped into place.
Connector Cable
Plastic Clip
Figure 5.6 Snapping Plastic Clip to Connector Cable
7.Insert the blue plug of the connector cable into the catheter connector socket on the
right side of the Impella® Console. Using the arrows as guides, align the tab and slot
during connection as shown in Figure 5.7. A single beep followed by a series of three
beeps confirms the connection.
Preventing Purge Line
Kinking
To prevent purge line kinking,
be sure to snap the plastic
clip on the pressure reservoir
to the correct location on the
connector cable. If the clip is
placed too close to the gray
connector, the purge line may
become kinked and fluid will
not flow freely.
During the procedure, check
the clip regularly to make
sure it remains correctly
positioned, especially after
changing the purge tubing.
Console Color Coding
The connectors on the
Impella® Console are
color-coded. The pressure
connector socket on the left
side of the console has yellow
markings that match the
yellow plug on the end of the
pressure transducer cable; the
catheter connector socket on
the right side of the console
has blue markings that match
the blue plug on the end of
the connector cable.
Align the arrow on the
connector cable with the
arrow on the catheter
connector socket
Figure 5.7 Attaching the Connector Cable to the Console
5.5
6.Snap the plastic clip (located on the pressure reservoir of the clear sidearm) to the
connector cable as shown in Figure 5.6.
Connecting the Pressure Transducer Cable
1.Once the Impella® 5.0 Catheter is plugged into the console, the console automatically
initiates the startup procedure for the Impella® 5.0 System and displays the screen
shown in Figure 5.8.
P-Perf
P0
LV4509
Flow [L/min]
100%
?.?
Pump Test
-500
0:01
<
Connect the gray pressure
measurement cable to the left
socket on the console and to
the purge pressure transducer...
<
10 s
Figure 5.8 Connect Pressure Transducer Cable Screen
2.Connect the gray pressure transducer cable to the left socket on the console (as shown
in Figure 5.9) and to the purge pressure (CM-Set) transducer.
Figure 5.9 Connecting the Pressure Transducer Cable to the Console
5.6
P-Perf
P0
LV4509
3.Once the gray cable is connected to the console and transducer, the console displays
the screen shown in Figure 5.10.
Flow [L/min]
100%
?.?
Pump Test
24
0:34
<
1. Flush purge line and connect to
reservoir / filter on catheter
2. Flush purge lumen until purge
pressure exceeds 350 mmHg.
<
10 s
Figure 5.10 Flush Purge Line and Purge Lumen Screen
Priming the Impella® 5.0 Catheter Purge Lumen
1.Connect the CM-Set to the yellow check valve on the clear sidearm (filter unit) of the
catheter as shown in Figure 5.11.
Alternative Method for
Producing the Bolus
Press and hold the “Bolus”
soft button. A second “Bolus”
soft button will be displayed.
Press and hold the two
“Bolus” soft buttons until
the Impella® Console beeps,
indicating that the purge
pressure has reached
350 mmHg.
Stopping the Bolus
Figure 5.11 Connecting CM-Set to Impella® 5.0 Catheter
2.Deliver an 8 cc bolus or use the alternative method for producing the bolus described in
the sidebar.
If the bolus is not stopped
prior to reaching 700 mmHg,
the Impella® Console will
alarm due to high purge
pressure. The infusion pump
will alarm and stop the bolus
at 1000 mmHg.
5.7
3.Once the purge pressure reaches 350 mmHg, the console will switch to the “Ready to
Insert” screen shown in Figure 5.12.
P-Perf
Flow [L/min]
P0
LV4509
100%
?.?
2
1
Pump Test
1:15
Impella catheter is ready to be
inserted
10 s
Figure 5.12 Ready to Insert Screen
4. Confirm fluid exiting the catheter, as shown in Figure 5.13.
Figure 5.13 Discharging Fluid from Catheter Outlet Area
5. T he “Ready to Insert” screen will switch to the placement signal screen within 10
seconds.
5.8
Inserting the Impella® 5.0 Catheter
assembly.
Handle with care. The Impella® 5.0 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.
1. Identify the femoral artery and perform a cut-down of 3 to 5 cm.
Use Fluoroscopy for
Placement
performance 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® 5.0 Catheter
after placement, TEE does
not allow visualization of the
entire catheter assembly or
guidewire and is inadequate
for reliably placing the
Impella® 5.0 Catheter across
the aortic valve.
2. E xpose the femoral artery. Wrap vessel loops, one distal and one proximal to the
subsequent point of incision, one and a half times around the artery. Make the vessel
loops as far apart as possible (see Figure 5.14).
Guidewire
U-Stitches
Femoral Artery
Proximal Vessel Loop
Distal Vessel Loop
Figure 5.14 Cut-Down Insertion of the Impella® 5.0 Catheter
3.To prepare the repositioning sheath, remove the luer plug at the end of the sidearm
tube and flush the tube with 0.9% NaCl solution.
Place the luer plug back in the sidearm tube and secure the plug.
5.9
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.
Use in Open Heart
Surgery
4.Make the incision as close as possible to the distal loop. Insert a 6 Fr diagnostic
catheter with no side holes (AL1 or Multipurpose without side holes recommended)
over a diagnostic 0.035 inch or 0.038 inch guidewire into the left ventricle.
If the Impella® 5.0 Catheter
is used in the OR as part
of open heart surgery,
manipulation may be
performed only through the
9 Fr steering catheter. Direct
manipulation of the catheter
assembly through the aorta or
ventricle may result in serious
damage to the Impella® 5.0
Catheter and serious injury to
the patient.
5.Remove the diagnostic guidewire and exchange it for the supplied 0.025 inch
placement guidewire.
6. H
old tension on the proximal vessel loop to prevent bleeding. Straighten the blue
pigtail and thread it over the 0.025 inch placement guidewire (see Figure 5.15). Wet the
cannula with sterile water and backload the catheter onto the placement guidewire.
One or two people can load the catheter on the guidewire.
1cm
Inlet
Catheter (with marking)
Avoid Damaging
Inflow Area
During placement of the
Impella® 5.0 Catheter, take
care to avoid damage to the
inflow area while holding
the catheter and loading the
placement guidewire.
Outlet
Pigtail
Guidewire
Sensor
Figure 5.15 Guidewire Placement
One-person technique
a.Advance the placement guidewire into the Impella® 5.0 Catheter and stabilize
the cannula between the fingers. This prevents pinching of the inlet area. The
placement guidewire must exit the outlet area on the inner radius of the cannula,
as shown in Figure 5.15, and align with the straight black line on the catheter. The
cannula can be hyperextended as necessary to ensure the placement guidewire
exits on the inner radius of the cannula.
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 placement guidewire must exit the outlet area on the inner radius of the
cannula and align with the straight black line on the catheter. The physician can
focus on advancing the placement guidewire and, if the cannula needs to be
hyperextended, the scrub assistant is available to assist.
7.Make a transverse incision at the guidewire for the 21 Fr catheter. Use U-stitches
(see Figure 5.14) instead of purse string sutures to avoid stenosis of the vessel after
explantation.
GP IIb-IIIa Inhibitors
8. Administer heparin and achieve ACT of at least 250 seconds.
If the patient is receiving a
GP IIb-IIIa inhibitor, the
Impella® 5.0 Catheter can be
inserted when ACT is 200 or
above.
9. Insert the catheter into the vessel and advance along the 0.025 inch placement
guidewire until resistance is met at the proximal vessel loop.
5.10
11.Advance the repositioning sheath, located on the catheter shaft, through the incision
and into the femoral artery until bleeding is controlled. Secure the sheath outside of the
vessel using the supplied suture loop.
To prevent device failure, do not start the Impella® 5.0 Catheter until the placement
guidewire has been removed.
guidewire.
12.Stabilize the guidewire and repositioning sheath and advance the catheter through
the sheath. Follow the catheter under fluoroscopy as it is advanced across the aortic
valve, positioning the inlet area of the catheter approximately 4 cm below the aortic
valve annulus and in the middle of the ventricular chamber, free from the mitral valve
chordae. Be careful not to coil the guidewire in the left ventricle. (Refer to Section 6 for
information about console waveforms during placement.)
13.When the catheter is correctly positioned, slightly loosen the proximal vessel loop and
remove the 0.025 inch guidewire. Leave at least 2 to 3 cm of the repositioning sheath
inside the vessel.
14.Tighten the prepared U-stitches to seal the sheath.
15.Loosen the distal vessel loop. Then loosen the proximal vessel loop.
Do NOT Touch Inlet,
Outlet, or Sensor Areas
While feeding the Impella®
5.0 Catheter through the
femoral artery, hold the
catheter at the cannula or
motor housing. Do NOT
touch the inlet, outlet, or
sensor areas.
Maintaining ACT
After insertion of the catheter
(and until explant), ACT
should be maintained at 160
to 180 seconds.
5.11
10.Loosen the proximal vessel loop and advance the catheter into the vessel. When the
motor housing is entirely past the proximal vessel loop, temporarily tighten the loop to
control bleeding.
Positioning and Starting the Impella® 5.0
Catheter
Retrograde flow will occur across the aortic valve if the Impella® 5.0 Catheter is set
at performance level P0.
1.While the catheter is being advanced in the aorta, the initial placement signal has
the characteristics shown in Figure 5.16. The inlet area of the catheter has not passed
the aortic valve.
Flow [L/min]
P-Perf
P0
LV4509
100%
0.0
8
–2
10 s
Figure 5.16 Initial Placement Signal
2.Gently advance the catheter forward until a pulsatile waveform is present on the
placement signal screen (see Figure 5.17). This signal is generated when the inlet area
of the catheter crosses the aortic valve.
P-Perf
Importance of Proper
Catheter Placement
When the catheter is not
correctly placed, there is no
effective unloading of the
ventricle (hydraulic short
circuit). The patient may not
be profiting from the flow
rate shown on the console.
P0
LV4509
Flow [L/min]
100%
0.0
33
2
10 s
Figure 5.17 Placement Signal as the Catheter Crosses the Aortic Valve
5.12
4.Increase performance level from P0 to P2. The catheter operation indicator to the
right of the battery symbol at the top of the screen will rotate when the catheter is
operating.
P-Perf
P9
LV4509
Flow [L/min]
100%
5.0
35
1
Dual Signal
I
Confirming Differential
Pressure Sensor Zero
If the lower value of the
differential pressure signal
is not within 6 mmHg of
0 when the Impella® 5.0
Catheter is in place across
the aortic valve, zero the
differential pressure sensor.
(The zeroing process is
described in section 6 of this
manual.)
P
10 s
Figure 5.18 Confirming Placement on the Dual Signal Screen
5.Increase the performance level to P9 to confirm correct and stable placement. Evaluate
the catheter position in the aortic arch and remove any excess slack. The catheter
should align against the lesser curvature of the aorta rather than the greater curvature.
Verify placement with fluoroscopy and with the dual signal screen (see Figure 5.18).
6.Make sure there is no bleeding at the transition from the repositioning sheath to the
femoral artery. Close and dress the wound. Secure the repositioning sheath by suturing
it to the skin using the yellow eyelet on the sheath.
7.Attach the anticontamination sleeve to the sheath. Lock it in place by turning clockwise.
Secure the catheter by tightening the connected anchoring ring.
8.Carefully extend the anticontamination sleeve to maximum length and secure the end
closest to the red Impella® plug by tightening the anchoring ring.
Vascular Closure
When securing the
repositioning sheath, vascular
closure may be difficult in
obese patients with extensive
adipose tissue.
9.Reposition the catheter as necessary. Optimal catheter position is indicated on the
placement monitoring screen.
5.13
3. C
onfirm that the console displays a pulsatile waveform and the inlet area of the
Impella® 5.0 Catheter is approximately 4 cm below the aortic valve.
Replacement Time
If the purge flow is more
than 7 mL/h or the dextrose
concentration is less than
20%, replacement time
will be less than 2 minutes.
Replacement should always
be performed as quickly as
possible.
Replacing the Purge Tubing
When replacing the purge tubing, the replacement process must be completed
within 2 minutes. The Impella® 5.0 Catheter may be damaged if replacement takes
longer than 2 minutes.
1.Prepare a 20% dextrose solution with 50 IU heparin/mL.
2.Connect new purge tubing and CM-Set to the 20% dextrose solution.
3.Flush the purge tubing and CM-Set manually and close the roller clamp.
4.Press BOL on the infusion pump and enter a bolus release of 0.5–1 mL. Press OK to
start the bolus. Multiple bolus releases may be required to reach 600 mmHg.
5.When the purge pressure on the Impella® Console reaches 600 mmHg, stop the bolus.
6.Press the red STOP key on the infusion pump to stop the infusion, then close the roller
clamp.
7.Disconnect the current CM-Set from the catheter at the yellow check valve and from
the gray pressure cable.
8.Open the door to the infusion pump and remove the current purge tubing.
9.Connect the new CM-Set to the catheter at the yellow check valve and to the gray
pressure cable. Open the roller clamp.
10.Load the new purge tubing into the infusion pump. Close the infusion pump door.
11.Once the change out has occurred and the new purge tubing is threaded through the
infusion pump, press VTBD to enter the new bag volume.
12.Press C on the keypad to clear the remaining volume and then enter the volume of the
new bag.
13.Press OK to accept the new value.
14.Press the green Start button to start the infusion.
15.Press BOL on the infusion pump and enter a bolus release of 0.5–1 mL. Press OK to
start the bolus to increase purge pressure back to the normal operating range.
16.If the purge pressure on the Impella® Console reaches 600 mmHg, press STOP on the
infusion pump. Normal operating range is 300–700 mmHg.
5.14
Purge System Troubleshooting
Low Purge Pressure
If at any time during the course of support with the Impella® 5.0 Catheter, the
Impella® Console alarms “Low Purge Pressure,” follow the instructions below.
An Impella 5.0 Catheter in stable operation should never require an abrupt or significant
increase in purge flow to maintain purge pressure. Stable operation is defined as operation in
which the following criteria are met:
®
Purge Pressure Range
Purge pressure range:
300-700 mmHg
• No leaks in any purge tubing connections
• No recent changes in dextrose concentration
• Constant performance level
• Purge flow maintained with only small incremental changes in purge flow
After confirming stable operation as defined above, if you observe a condition in which purge
pressure drops and purge flow requires an abrupt or significant increase (eg, doubling the
purge flow) to maintain purge pressure over 300 mmHg, this could be an indication of catheter
damage.
The steps that follow describe how to respond to the “Low Purge Pressure” alarm shown in
Figure 5.19 if the criteria for stable operation listed above are met; however, the nature of the
situation will determine the starting point for your response as shown in Table 5.1.
Warning
0:06
Low Purge Pressure
Increase Purge Rate!
Check Purge System!
Figure 5.19 Low Purge Pressure Screen
5.15
Table 5.1 Handling Low Purge Pressure Alarms
Observation
Action
Stable operation with purge flow
between 4–20 mL/h
Follow the instructions outlined below, starting at Step 1.
Stable operation with abrupt or
Immediately go to Step 7 of the instructions outlined below.
significant increase in purge flow
needed to maintain purge pressure
Stable operation with dextrose
≥20% and purge flow ≥30 mL/h
Immediately go to Step 7 of the instructions outlined below.
Heparin and Dextrose
Infusion Rates
1. P ress BOL on the infusion pump and enter a bolus release of 0.5 mL. Press OK to
start the bolus.
The purge fluid contains
heparin and dextrose. When
changing the purge rate,
carefully assess how the new
heparin and dextrose infusion
rates may affect the patient.
For example, significantly
increasing the purge rate may
cause bleeding by increasing
the amount of heparin
delivered to the patient. As a
result, the patient’s systemic
heparin dose may need to be
adjusted.
2. Inspect the purge system for leaks.
Refer to Tables 5.2 and 5.3
for Abiomed-recommended
dextrose and heparin
concentrations in purge fluid.
3. P ress STOP if the Impella® Console shows purge pressure approximately 600 mmHg.
Repeat Step 1 if necessary to reach 600 mmHg. If needed, increase infusion rate on the
infusion pump until the purge pressure is maintained within the range of 300 to.
700 mmHg.
4. Switch to the 5 minute scale screen and monitor the purge pressure.
5. If the pressure remains stable, no other action is required. If the purge pressure is
not stable and requires repeated boluses, proceed to Step 6.
Figure 5.20 is an example of normal, stable behavior as displayed on the 5 minute .
scale screen.
• A single bolus is delivered to raise purge pressure to 600 mmHg.
• Pressure is maintained above 300 mmHg.
• Normal “settling” is shown after bolus.
P-Perf
P9
LV4509
Flow [L/min]
100%
5.0
449
<
<
5 min
Figure 5.20 Normal Purge Pressure on 5 Minute Scale Screen
5.16
6. If repeated boluses within a 5 minute period are required (see Figure 5.21) and
increasing the infusion rate and increasing the dextrose concentration have not been
effective, proceed to Step 7.
Figure 5.21 is an example of abnormal purge pressure behavior as displayed on the.
5 minute scale screen.
• Repeated boluses are given to try to maintain purge pressure above 300 mmHg.
• Pressure is not maintained.
• Time for the pressure to drop below 300 mmHg can vary from as little as 10 seconds
to as much as 60 seconds.
• Look for signature “saw tooth” pattern.
Flow [L/min]
P-Perf
P9
LV4509
100%
5.0
60
<
<
5 min
Figure 5.21 Abnormal Purge Pressure on 5 Minute Scale Screen
7. If the low purge pressure alarms remain unresolved for more than 5 minutes, this may
be a sign of catheter damage. Complete the following steps immediately:
a.Change the catheter performance level to P1 by pressing the P-PERF button and the
down arrow until P1 is displayed in the top left corner of the screen. Press OK button.
b.Slowly pull back on the Impella® 5.0 Catheter until the catheter is in the descending
aorta (approximately 20 cm for an average size patient; 1 cm marks are available .
on the catheter).
c.Turn off the Impella® 5.0 Catheter by pressing the P-PERF button and the down
arrow until P0 is displayed in the top left corner of the console screen. Press OK
button.
dTurn off the Impella® Console and purge flow.
e.Remove the Impella® 5.0 Catheter with the use of fluoroscopic imaging. If no
fluoroscopy is available, leave the catheter in the descending aorta until fluoroscopy
is available for visual assistance during removal of the catheter.
5.17
High Purge Pressure
High purge pressure alarms, if left unresolved, can deprive the Impella® 5.0 Catheter of the
continuous flow of purge fluid needed to protect the motor. If blood enters the motor, the motor
will have to work harder to maintain the set performance level. Motor current may increase
gradually or sharply and the Impella® 5.0 Catheter may stop running.
If the purge pressure exceeds 700 mmHg, the Impella® Console displays the alarm message
shown in Figure 5.22. To resolve the high purge pressure alarm, perform the following steps.
Warning
0:06
High Purge Pressure
Unresolved High Purge
Pressure Alarms
Decrease Purge Rate!
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. Consider replacing the
Impella® 5.0 Catheter.
Check Purge System!
Figure 5.22 High Purge Pressure Screen
1.Make sure that the clip on the pressure reservoir of the clear sidearm is not attached
too close to the gray connector causing the purge line on the clear sidearm to kink..
If the clear sidearm is kinked, reposition the clip further down the connector cable away
from the gray connector to remove the kink and allow purge fluid to flow freely.
2.Carefully inspect the purge tubing, clear sidearm, and entire visible length of the
catheter for kinks, keeping in mind that kinks may be difficult to see and the purge
lumen inside the clear sidearm may remain kinked after you “unkink” the clear sidearm.
3.If you do not detect any kinks, decrease the purge flow rate by 1 mL/h until the purge
pressure is less than 700 mmHg. Do not decrease purge flow rate to less than 4 mL/h.
4.If purge pressure remains above 700 mmHg, decrease dextrose concentration to 5%.
5.18
Purge Pressure Management Strategies
Figure 5.23 summarizes purge pressure management strategies.
20% Dextrose Solution with 50 Units Heparin/mL
Purge flow rate 7 mL/h
300 mmHg
Low Purge Pressure
less than 300 mmHg
Purge flow
less than
20 mL/h
700 mmHg
Purge Pressure
between 300 and 700 mmHg
Purge flow
greater than
20 mL/h
High Purge Pressure
greater than 700 mmHg
Purge flow
between
4 mL/h and 20 mL/h
1. Deliver 0.5 mL bolus.
1. Deliver 1 mL bolus.
1. Purge pressure OK.
2. Increase purge fluid
infusion rate by 0.5
mL/h to maintain
purge pressure
> 300 mmHg.
2. Increase dextrose
concentration.*
2. Monitor after changes
in performance (P) level.
Purge flow
less than
4 mL/h
Purge flow
greater than
4 mL/h
1. Inspect tubing for
kinks or closed
clamps.
1. Decrease infusion
rate by 1 mL/h.
2. Decrease dextrose
concentration.*
3. Adjust infusion rate
as needed.
3. Adjust infusion rate
as needed.
* Refer to the instructions for changing purge fluid earlier in this section.
Changes in purge rate or dextrose concentration can take up to 1 hour to become effective.
Figure 5.23 Purge Management
Tables 5.2 and 5.3 describe the amounts of dextrose and heparin delivered in the purge fluid.
The green shading in the tables indicates the Abiomed-recommended concentrations of dextrose
and heparin in the purge fluid.
Table 5.2 Amount of Dextrose Delivered in the Purge Fluid (g/h)
Purge Fluid Infusion Rate
4
Dextrose
Concentration
7
8
10
12
14
16
18
20
mL/h
mL/h
mL/h
mL/h
mL/h
mL/h
mL/h
mL/h
mL/h
5%
0.2
0.35
0.4
0.5
0.6
0.7
0.8
0.9
1
10%
0.4
0.7
0.8
1
1.2
1.4
1.6
1.8
2
20%
0.8
1.4
1.6
2
2.4
2.8
3.2
3.6
4
40%
1.6
2.8
3.2
4
4.8
5.6
6.4
7.2
8
Note: Green shading indicates the Abiomed-recommended concentration of dextrose in the purge fluid
Table 5.3 Amount of Heparin Delivered in the Purge Fluid (IU/h)
Purge Fluid Infusion Rate
4
Heparin
Concentration
7
8
10
12
14
16
18
20
mL/h
mL/h
mL/h
mL/h
mL/h
mL/h
mL/h
mL/h
mL/h
12.5 IU/mL
50
87.5
100
125
150
175
200
225
250
25 IU/mL
100
175
200
250
300
350
400
450
500
50 IU/mL
200
350
400
500
600
700
800
900
1000
Note: Green shading indicates the Abiomed-recommended concentration of heparin in the purge fluid
5.19
Downstream Occlusion
If a “downstream occlusion” alarm occurs on the infusion pump (see Figure 5.24), the purge
fluid flow stops.
1.Inspect the purge tubing for any kinks or defects.
2.Make sure the roller clamp is open.
3. Press the START key to resume the infusion.
4.If the alarm persists, inspect the tubing down the fluid path. Close the door and press
the START key to resume the infusion.
Figure 5.24 Downstream Occlusion Alarm
Patient Weaning
Weaning the patient from the Impella® 5.0 Catheter is at the discretion of the physician.
The following weaning protocols are provided as guidance only.
Rapid Weaning
1. Initiate rapid weaning by decreasing catheter performance level in 2-level steps at
intervals of several minutes (for example, P6 to P4 to P2). Do NOT decrease the
performance level to below P2 until just before removing the catheter from the
ventricle.
5.20
3. If the patient’s hemodynamics remain stable, decrease the performance level to P1,
pull the catheter into the aorta, and stop the motor by decreasing the performance
level to P0.
4. Explant the catheter.
5.Follow institutional guidelines for arterial closure.
6.Disconnect the connector cable from the Impella® Console and the catheter by
sliding back the locking sleeves (at the <= => markings) and removing the plugs .
(see Figure 5.25). Do NOT twist the plugs because the contact pins may
be damaged.
Disconnecting Connector
Cable
When disconnecting the
connector cable from the
console and catheter, do NOT
twist the plugs because the
contact pins may be damaged.
Figure 5.25 Disconnecting the Connector Cable from the Console
7.Press MENU. Select “Switch Off Console” and press OK.
Remove the Impella® 5.0
Catheter With Care
Slow Weaning
1.Initiate slow weaning by decreasing catheter performance level in 2-level steps over
time as cardiac function allows (for example, P6 to P4 to P2). Do NOT decrease
the performance level to below P2 until just before removing the catheter from the
ventricle.
Removal of the Impella® 5.0
Catheter must be completed
with care to avoid damage to
the catheter assembly.
2.When the performance level has been reduced to P2, maintain the patient on P2
support until the patient’s hemodynamics remain stable before discontinuing circulatory
support.
3.If the patient’s hemodynamics remain stable, decrease the performance level to P1,
pull the catheter into the aorta, and stop the motor by decreasing the performance level
to P0.
4.Explant the catheter.
5.Follow institutional guidelines for arterial closure.
6.Disconnect the connector cable from the Impella® Console and the catheter by
sliding back the locking sleeves (at the <= => markings) and removing the plugs
(see Figure 5.25). Do NOT twist the plugs because the contact pins may be
damaged.
7.Press MENU. Select “Switch Off Console” and press OK.
5.21
2. W
hen the performance level has been reduced to P2, maintain the patient on P2
support for at least 10 minutes before discontinuing circulatory support.
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® 5.0 Catheter.............................................................................. 6.4
Background......................................................................................................6.4
Correct Impella® 5.0 Catheter Position.............................................................6.6
Impella® 5.0 Catheter Too Far into the Left Ventricle.........................................6.6
Impella® 5.0 Catheter Inlet in the Aorta............................................................ 6.7
Impella® 5.0 Catheter in Papillary Muscle......................................................... 6.7
Color Doppler Echocardiography..................................................................... 6.10
Post-insertion Positioning (PIP) Checklist........................................................ 6.11
Understanding and Managing
Impella® 5.0 Catheter Position Alarms............................................. 6.11
Correct Impella® 5.0 Catheter Position........................................................... 6.12
Impella® 5.0 Catheter Fully in Ventricle or Fully in Aorta................................. 6.13
Low Native Heart Pulsatility............................................................................ 6.14
Impella® 5.0 Catheter Outlet Area on or Near Aortic Valve............................. 6.15
Suction......................................................................................................6.16
Hemolysis..................................................................................................6.16
Pressure Sensor Drift and Sensor Failure......................................6.18
Sensor Drift and Effects on Flow..................................................................... 6.18
Sensor Failure and Effects on Flow Calculations.............................................. 6.19
Sensor Failure and Effects on Position Control................................................ 6.19
Suction Detection During Sensor Drift or Sensor Failure.................................. 6.19
Operating the Impella® 5.0 Catheter Without
Heparin in the Purge Solution........................................................... 6.20
How to Change to A Backup Console................................................ 6.20
Patient Management Overview
6
Patient Management Topics
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® 5.0 Catheter when transferring a patient from one
bed to another.
• To prevent purge line kinking, do not allow the red Impella® plug to hang freely from the
catheter and do not bend the catheter near the red Impella® plug. Consider attaching the
red Impella® plug and catheter to a short armboard to prevent the catheter from kinking
near the plug.
• Use care when moving or turning a patient; the Impella® 5.0 Catheter may move out of
position and cause a positioning alarm.
• Monitor pedal pulses.
6.1
Battery Power Note
If the Impella® Console
is allowed to discharge
completely and the system
shuts down due to low
battery, the console will need
to charge for an extended
period of time before the
console will turn on again.
Transport Within the Hospital
Patients supported with the Impella® 5.0 System may require transport within the hospital for
various reasons. Transport can be safe and simple for patients supported with Impella® 5.0
Catheter.
Considerations for transport within the hospital:
• The Impella® 5.0 System is designed to operate on battery power for at least 1 hour.
• Confirm that the battery capacity displayed on the console is 100% and the battery
capacity of the infusion pump is sufficient.
• If transport time might be longer than 1 hour, bring an extension cord and confirm that
you will be able to connect the console to AC power once you arrive at your destination.
• Use care when rolling the Impella® 5.0 System cart, and pay close attention when going
over thresholds and through elevator doors.
• Do not stress the Impella® 5.0 Catheter cable from the console to the red Impella® plug.
Right Heart Failure
The Impella® 5.0 Catheter is a left-side support device only. Patients being supported by the
Impella® 5.0 Catheter 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® 5.0 Catheter
• Suction alarms
• Elevated filling 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.
6.2
ECG Interference
6
Operating the Impella® Console with the Impella® Power Supply may cause interference with
electrocardiogram (ECG) signals. 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® Power Supply
temporarily from AC power to obtain an undisturbed signal. Carefully observe the battery status
while running the Impella® Console on battery power.
Latex
The Impella® 5.0 Catheter and all accessories approved by Abiomed are 100% latex free.
Positioning and Placement Devices
High quality fluoroscopic imaging is the best method for determining catheter position
and is required for Impella® 5.0 Catheter placement. If fluoroscopy is not readily available,
transesophageal echocardiography (TEE) or transthoracic echocardiography (TTE) is appropriate
for determining catheter position. (TEE and TTE are discussed next in this section.)
Alternative methods for determining catheter position include portable C-Arm fluoroscopy and
chest x-ray.
Notes on Imaging:
All imaging technology represents the anatomy in two dimensions (2D). It is not possible to
assess the interactions between the Impella® 5.0 Catheter and the intraventricular anatomy that
occur in three dimensions (3D). Abiomed strongly recommends that the Impella® 5.0 Catheter be
repositioned, even if the imaging view shows correct position.
Alternative imaging techniques, such as transesophageal echocardiography (TEE), can be useful
to confirm the position of the Impella® 5.0 Catheter after placement. However, TEE is inadequate
to reliably perform initial placement across the aortic valve. TEE does not allow visualization of
the entire catheter assembly or guidewire.
Use Fluoroscopy for
Placement
performance 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® 5.0 Catheter
after placement, TEE does
not allow visualization of the
entire catheter assembly or
guidewire and is inadequate
for reliably placing the
Impella® 5.0 Catheter across
the aortic valve.
6.3
Use of Echocardiography for Positioning of the
Background
Echocardiography is a commonly used tool for evaluating the position of the Impella® 5.0
Catheter relative to the aortic valve and other intraventricular structures post-placement. The
best echocardiographic views for positioning the Impella® 5.0 Catheter in the left ventricle
are a long axis transesophageal echocardiogram (TEE) or a parasternal long axis transthoracic
echocardiogram (TTE). These long axis views allow you to see both the aortic valve and Impella®
5.0 Catheter inlet area. Evaluate the position of the Impella® 5.0 Catheter if the Impella® Console displays position
alarms or if you observe lower than expected flows or signs of hemolysis. If the catheter does
not appear to be correctly positioned, initiate steps to reposition it.
The illustrations on the following page identify the structures you would expect to see in
transesophageal echocardiography (top) and transthoracic echocardiography (bottom). In these
illustrations, the Impella® 5.0 Catheter is positioned correctly; however, these depictions are
stylized and in actual echocardiograms the pigtail and inlet and outlet areas may not be seen as
distinctly.
6.4
Impella® 5.0
Catheter
outlet area
LA
Mitral valve
6
Transesophageal Echocardiogram (TEE) of Impella® Catheter
Location of mitral
chordae
Aortic valve
Papillary
muscle
RV
LV
Impella® 5.0
Catheter inlet area
Transthoracic Echocardiogram (TTE) of Impella® Catheter
Impella® 5.0
Catheter
inlet area
RV
Septum
Impella® 5.0
Catheter
outlet area
Papillary
muscle
Aorta
LV
LA
Location of
mitral chordae
Mitral valve
Figure 6.1 Labeled TEE and TTE Images of the Impella® 5.0 Catheter Position
6.5
Four Impella® 5.0 Catheter positions you are likely to encounter when examining
echocardiograms from patients supported with the Impella® 5.0 Catheter include:
• Correct Impella® 5.0 Catheter position
• Impella® 5.0 Catheter too far into the left ventricle
• Impella® 5.0 Catheter inlet in the aorta
• Impella® 5.0 Catheter in papillary muscle
The following pages describe each situation. Figure 6.2 illustrates a transesophageal
echocardiogram (TEE) of each situation. Figure 6.3 illustrates a transthoracic echocardiogram
(TTE) of each.
Correct Impella® 5.0 Catheter Position
For optimal positioning of the Impella® 5.0 Catheter, the inlet area of the catheter should be
about 4 cm below the aortic valve annulus and well away from papillary muscle and subannular
structures. The outlet area should be well above the aortic valve. If the Impella® 5.0 Catheter is
correctly positioned, echocardiography will likely show the following, as depicted in .
Figures 6.2a (TEE) and 6.3a (TTE):
• Catheter inlet area about 4 cm below the aortic valve
• Catheter outlet area well above the aortic valve (frequently not visible on TEE or TTE
images)
• Catheter angled toward the left ventricular apex away from the heart wall and not curled
up or blocking the mitral valve
Impella® 5.0 Catheter Too Far into the Left Ventricle
If the Impella® 5.0 Catheter is positioned too far into the left ventricle, the patient will not
receive the benefit of Impella® 5.0 Catheter support. Blood will enter the inlet area and exit the
outlet area within the ventricle. Obstruction of the Impella® 5.0 Catheter inlet area can lead to
increased mechanical forces on blood cell walls and subsequent hemolysis, which often presents
as dark or blood-colored urine. If the Impella® 5.0 Catheter is too far into the left ventricle,
echocardiography will likely show the following, as depicted in Figures 6.2b (TEE) .
and 6.3b (TTE):
• Catheter inlet area more than 4 cm below the aortic valve
• Catheter outlet area across or near the aortic valve
• Catheter too close to the heart wall or mitral valve
6.6
Impella® 5.0 Catheter Inlet in the Aorta
6
If the inlet area of the Impella® 5.0 Catheter is in the aorta, the patient will not receive the
benefit of Impella® 5.0 Catheter support. The catheter will pull blood from the aorta rather than
the left ventricle. In addition, suction is possible if the inlet area is against the wall of the aorta
or valve sinus. If the inlet area of the Impella® 5.0 Catheter is in the aorta, echocardiography will
likely show the following, as depicted in Figures 6.2c (TEE) and 6.3c (TTE):
• Catheter inlet area in aorta or near the aortic valve
• Catheter pigtail too close to the mitral valve
Impella® 5.0 Catheter in Papillary Muscle
If the inlet area of the Impella® 5.0 Catheter is too close to or entangled in the papillary muscle
and/or subannular structures surrounding the mitral valve, it can affect mitral valve function
and negatively impact catheter flow. If the inlet area of the catheter is lodged adjacent to the
papillary muscle, the inflow may be obstructed, resulting in suction alarms. This positioning is
also likely to place the outlet area too close to the aortic valve, which can cause outflow at the
level of the aortic valve with blood streaming back into the ventricle, resulting in turbulent flow
and hemolysis. If the Impella® 5.0 Catheter is too close to or entangled in the papillary muscle,
echocardiography will likely show the following, as depicted in Figures 6.2d (TEE) .
and 6.3d (TTE):
• Catheter pigtail in papillary muscle
• Catheter inlet area more than 4 cm below the aortic valve or lodged between papillary
muscle and the myocardial wall
• Catheter outlet area too close to the aortic valve
The following figures depict transesophageal and transthoracic echocardiographic images of
these four Impella® 5.0 Catheter positions. Figure 6.2 shows four transesophageal depictions of
Impella® 5.0 Catheter position and Figure 6.3 shows four transthoracic depictions of
Impella® 5.0 Catheter position.
6.7
Correct Impella® 5.0 Catheter Position (TEE)
6.2a
Impella® 5.0 Catheter Too Far into Left Ventricle (TEE)
6.2b
• Catheter outlet area well above the aortic valve
• Catheter angled toward the left ventricular apex away
from the heart wall and not curled up or blocking the
mitral valve
Impella® 5.0 Catheter Inlet in Aorta (TEE)
6.2c
Impella® 5.0 Catheter in Papillary Muscle (TEE)
6.2d
• Catheter inlet area more than 4 cm below the aortic valve or
lodged between papillary muscle and the myocardial wall
Figure 6.2 Transesophageal Echocardiographic (TEE) Illustrations of Impella® 5.0 Catheter Position
6.8
Impella® 5.0 Catheter Too Far into Left Ventricle (TTE)
6.3b
6
Correct Impella® 5.0 Catheter Position (TTE)
6.3a
• Catheter outlet area well above the aortic valve
• Catheter angled toward the left ventricular apex away
from the heart wall and not curled up or blocking the
mitral valve
Impella® 5.0 Catheter Inlet in Aorta (TTE)
6.3c
Impella® 5.0 Catheter in Papillary Muscle (TTE)
6.3d
Papillary muscle
Aorta
• Catheter inlet area more than 4 cm below the aortic valve or
lodged between papillary muscle and the myocardial wall
Figure 6.3 Transthoracic Echocardiographic (TTE) Illustrations of Impella® 5.0 Catheter Position
6.9
Color Doppler Echocardiography
When moving a patient supported with an Impella® 5.0 Catheter, it is important to monitor
catheter migration. Adding color Doppler to an echo is another way to verify catheter position.
If the Impella® 5.0 Catheter is correctly positioned, a dense mosaic pattern of turbulence will
appear above the aortic valve near the outlet area of the catheter, as shown in the top image
in Figure 6.4. If, however, the echocardiogram reveals a dense mosaic pattern of turbulence
beneath the aortic valve (bottom image in Figure 6.4), this likely indicates that the outlet area
of the catheter is in the wrong position, that is, the catheter is too far into the ventricle or
entangled in papillary muscle. (Note: If using transesophageal echocardiography [TEE], look for
the mosaic patterns in the same locations relative to the aortic valve and Impella® 5.0 Catheter
outlet area.)
Correct Impella® 5.0 Catheter Position (Color Doppler TTE)
Incorrect Impella® 5.0 Catheter Position (Color Doppler TTE)
Figure 6.4 Correct and Incorrect Impella® 5.0 Catheter Position (Color Doppler TTE)
6.10
Post-insertion Positioning (PIP) Checklist
6
Completing the steps shown in the following post-insertion positioning checklist can help to
ensure proper position of the Impella® 5.0 Catheter following insertion. Pay particular attention
to positioning after the patient is moved from the operating room or catheterization laboratory.
1.Remove slack in the Impella® 5.0 Catheter by increasing performance level to P9 and
align the catheter against the lesser curvature of the aorta (rather than the greater
curvature).
2.Use fluoroscopy to verify that the slack has been removed.
3.Verify that the Impella® 5.0 Catheter inlet area is optimally positioned about 4 cm
below the aortic valve.
4.Return to previous performance level.
5.Secure the Impella® 5.0 Catheter at a firm external fixation point in the groin area.
Understanding and Managing
Impella® 5.0 Catheter Position Alarms
The Impella® Console continuously monitors the Impella® 5.0 Catheter based on the placement
signal and the motor current.
• Placement Signal: Is the signal pulsatile or flattened?
• Motor Current: Is the signal pulsatile or flattened?
If the system alarms with one of the positioning alarms described in this section, fluoroscopic
imaging is the best method for confirming position. You can also use TEE, TTE, or a standard
chest X-ray.
If the Impella 5.0 Catheter is either partly (just the pigtail) or completely in the ventricle,
reposition the catheter under imaging guidance. If guidance is not available, use the
repositioning guide to reestablish proper placement.
®
If the Impella® 5.0 Catheter is completely out of the ventricle, do not attempt to reposition the
catheter across the valve without a guidewire.
The tables on the following pages describe possible placement conditions and the expected
alarm messages, associated signal characteristics, and placement monitoring icons.
The placement monitoring
screen will display “Disabled
Due to Low Performance
Level” if catheter performance
level is less than P1. If there is
a problem with the pressure
sensor, it will display “Disabled
Due to Non Reliable Sensor.”
6.11
Correct Impella® 5.0 Catheter Position
If the Impella® 5.0 Catheter is in the correct position, the placement signal, motor current, dual
signal, and placement monitoring screens will appear as shown in Figure 6.5.
Placement Signal
P-Perf
P9
LV4509
Motor Current
Flow [L/min]
98%
5.0
35
1
P-Perf
Flow [L/min]
P9
5.0
98%
LV4509
0.80
0.69
Motor Current [A]
10 s
10 s
Placement signal will be pulsatile.
Motor current signal will be pulsatile.
Dual Signal
P-Perf
P9
LV4509
Flow [L/min]
98%
5.0
35
1
Dual Signal
I
P
Flow [L/min]
P-Perf
P9
LV4509
Ventricle
5.0
98%
35
1
Aorta
Pump Position OK
10 s
10 s
The Impella® 5.0 Catheter icon will be displayed
with the valve symbols in the middle of the
cannula.
Figure 6.5 Correct Impella® 5.0 Catheter Position
6.12
Impella® 5.0 Catheter Fully in Ventricle or Fully in Aorta
6
If the Impella® 5.0 Catheter is fully in the ventricle or fully in the aorta, the following warning will
appear:
Pump Position Wrong
Reposition Pump!
Confirm with OK and
Apply MENU for Reposition!
In this situation, the placement signal, motor current, dual signal, and placement monitoring
screens will appear as shown in Figure 6.6.
Placement Signal
P-Perf
P9
LV4509
Motor Current
Flow [L/min]
98%
5.3
8
-2
P-Perf
Flow [L/min]
P9
5.3
98%
LV4509
0.81
0.80
Motor Current [A]
10 s
10 s
Placement signal will be dampened or flat and
displayed flow rate will increase even though
patient is not being supported.
Dual Signal
P-Perf
P9
LV4509
Flow [L/min]
98%
Motor current signal will be dampened or
flat because there is little or no difference in
afterload between the Impella® 5.0 Catheter
inlet and outlet.
5.3
8
-2
Dual Signal
P8
98%
Ventricle
Aorta
LV4509
P-Perf
Flow [L/min]
Pump Position Wrong
98%
Ventricle
Aorta
P8
2.5
I
10 s
LV4509
Pump Position Wrong
Ventricle
P
2.5
Aorta
10 s
10 s
The Impella® 5.0 Catheter icon will scroll
through a series of three icons indicating that
the system is not able to differentiate between
the three possible conditions.
Figure 6.6 Impella® 5.0 Catheter Fully in Ventricle or Fully in Aorta
Repositioning Menu
Actions to take:
1.Under fluoroscopic or echocardiographic guidance, if available, reduce the performance
level to P2 and carefully reposition the Impella® 5.0 Catheter by either pushing the
catheter forward or pulling it back as needed.
The repositioning menu
can also be used as a guide
for correcting Impella® 5.0
Catheter positioning.
2.Confirm that the placement signal and motor current are both pulsatile.
6.13
Low Native Heart Pulsatility
When a patient has poor native ventricular function, the placement signal may remain pulsatile;
however, the amplitude will be dampened and both the minimum and maximum values will be
greater than zero because the aortic valve does not open and the Impella® 5.0 Catheter raises
the aortic blood pressure above the ventricular pressure during systole.
In a situation of low native heart pulsatility, the Impella® Console may not be able to determine
the catheter position and the placement signal, motor current, dual signal, and placement
monitoring screens will appear as shown in Figure 6.7.
Placement Signal
Flow [L/min]
P-Perf
P8
LV4509
Motor Current
98%
4.2
25
17
P-Perf
Flow [L/min]
P8
LV4509
4.2
98%
0.79
0.77
Motor Current [A]
10 s
10 s
Placement signal will show reduced pulsatility,
Motor current signal will be dampened or flat
and the lower value will be elevated above zero. due to small pressure gradients between the
Impella® 5.0 Catheter inlet and outlet.
Dual Signal
P-Perf
P8
LV4509
Flow [L/min]
98%
4.2
25
17
Dual Signal
I
P
P-Perf
Flow [L/min]
P8
LV4509
4.2
98%
25
17
Ventricle
Aorta
Pump Position Unknown
Due to Low Pulsatility
10 s
10 s
without the valve symbol.
Figure 6.7 Impella® 5.0 Catheter Position Unknown Due to Low Pulsatility
Actions to take:
1. Assess cardiac function.
6.14
Impella® 5.0 Catheter Outlet Area on or Near Aortic Valve
6
If the Impella® 5.0 Catheter outlet area is on or near the aortic valve, the catheter may be too
deep in the ventricle. The following warning will appear:
Pump Position Wrong
Pump Outlet Blocked!
Confirm with OK and
In this situation, the placement signal, motor current, dual signal, and placement monitoring
screens will appear as shown in Figure 6.8.
Placement Signal
P-Perf
P8
LV4509
Motor Current
Flow [L/min]
98%
4.4
25
-29
P-Perf
P8
LV4509
Flow [L/min]
4.4
98%
0.80
0.70
Motor Current [A]
10 s
10 s
Lower value of the placement signal will be
reduced significantly below zero.
Motor current signal will appear normal.
Dual Signal
P-Perf
P8
LV4509
Flow [L/min]
98%
Dual Signal
4.4
25
-29
I
P
P-Perf
P8
LV4509
Flow [L/min]
4.4
98%
25
-29
Ventricle
Aorta
Pump Position Wrong
Pump Outlet Blocked!
Press MENU for Reposition!
10 s
10 s
with the valve symbol blocking the outlet
window.
Figure 6.8 Impella® 5.0 Catheter Outlet Area on or near Aortic Valve
Actions to take:
1.Assess and adjust Impella® 5.0 Catheter position under fluoroscopic or
echocardiographic guidance, if available.
2.If fluoroscopic or echocardiographic guidance is not available, reduce the performance
level to P2 and gently pull the catheter back 1 cm and see if the condition resolves.
6.15
Suction
Suction may occur if the blood volume available for the Impella® 5.0 Catheter is inadequate or
restricted. Suction limits the amount of support that the Impella® 5.0 Catheter can provide to
the patient 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.
If a suction alarm occurs, follow the recommended actions in the alarm display by decreasing the
performance.
1.Check the catheter for correct positioning using imaging. Reposition the catheter 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 catheter 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 performance level 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 assist device (VAD) support. Patient conditions—
including catheter position, pre-existing medical conditions, and small left ventricular volumes—
may also play a role in patient susceptibility to hemolysis.
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.
Management technique may differ depending on the underlying cause of hemolysis. Table 6.1
provides guidance for various circumstances.
6.16
Table 6.1 Guide for Managing Hemolysis in Various Circumstances
6
Console Indicators
Clinical Indicators
Management
Impella 5.0 inlet
area in close
proximity to
intraventricular
wall
• Suction alarms
• Lower than expected flows
Imaging (see note)
• Reposition the Impella® 5.0 Catheter by rotating
or moving the catheter into or out of the ventricle
slightly. Either or both of these actions could help
move the inlet of the catheter away from the
intraventricular wall.
• If reposition will be delayed, reduce the flow by
1 or 2 performance levels if tolerated by patient
hemodynamics. Return performance level after
repositioning.
• Reassess position after performance level has
returned to desired target value.
Wrong catheter
position
• Position alarms with higher Imaging (see note)
than expected flows
• Suction alarms with lower
than expected flows
• Pump outlet blocked alarms
• Reposition the Impella® 5.0 Catheter by rotating
or moving the catheter into or out of the ventricle
slightly. Either or both of these actions could help
move the inlet of the catheter away from the
intraventricular wall.
• If reposition will be delayed, reduce the flow by
1 or 2 performance levels if tolerated by patient
hemodynamics. Return performance level after
repositioning.
• Reassess position after performance level has
returned to desired target value.
Higher than
needed flow
setting
• There may be no console
indicators
• Suction alarms
• Normal hemodynamics
• Native recovery
• Reduce performance level until patient pressure
starts to drop.
• Increase performance by 1 level.
Inadequate filling
volume
• Position alarms
• Suction alarms
• Lower than expected flows
• Low CVP
• Low PCWP
• Low AOP
• High PA pressures
• Right heart failure
• High urine output
• Increased bleeding or chest
tube drainage
• Reduce the flow by 1 or 2 performance levels 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.
Pre-existing
patient conditions
or other medical
procedures
N/A
• Patient past medical history
• Current procedures or
treatments
®
Note on imaging: All imaging technology represents the anatomy in two dimensions (2D). It is not possible to assess the
interactions between the Impella® 5.0 Catheter and the intraventricular anatomy that occur in three dimensions (3D).
Abiomed strongly recommends that the Impella® 5.0 Catheter be repositioned, even if the imaging view shows correct position.
6.17
Condition
Accuracy of Displayed
Flow Rate
Pressure Sensor Drift and Sensor Failure
The performance level of the Impella® 5.0 Catheter is automatically set to P2 during
zeroing if the catheter is operating above P0. Performance level remains at P2 after
zeroing and does not automatically return to its prior setting.
Under normal operating
conditions, displayed flow rate
can deviate from the actual
flow rate by up to 0.5 L/min.
Sensor Drift and Effects on Flow
Zeroing and Sensor Drift
Only zero the sensor when
you observe evidence of
sensor drift. Abiomed does
NOT recommend zeroing the
differential pressure sensor
when there is NO evidence
of sensor drift because the
performance level is reduced
to P2 during zeroing.
The electrical signal produced by the differential pressure sensor may drift over time. This drifting
is normal behavior and is characterized by an upward or downward shift in the placement signal
along the y-axis of the console display; however, the amplitude (peak-to-trough, or maximum to
minimum) of the waveform will not change. When sensor drifting occurs, it affects the Impella®
5.0 Catheter flow calculations and the displayed flow rate will not match the expected flow. (Refer
to Table 6.2 to see what the expected flow rates for each performance level should be.)
Table 6.2 Expected Flow Rate Displayed on Console
Performance Level
Flow rate (L/min)
P1
0.0 – 1.4
P2
0.5 – 2.6
P3
0.5 – 3.1
P4
0.9 – 3.4
P5
1.4 – 3.7
P6
1.8 – 4.0
P7
2.6 – 4.4
P8
3.4 – 4.7
P9
4.2 – 5.3
If you observe that the placement waveform has shifted up or down on the y-axis, or the
expected flow does not match the current performance level setting, zero the differential
pressure sensor by performing the following steps:
1.Press the SIGNAL key until the placement signal is displayed.
2.Press the ZERO key. “Placement Signal Offset Adjust” is displayed.
3.Press OK within 10 seconds to start the zeroing algorithm. The Console will display the
“Calculation is Running” message.
Resetting Performance
Level
After zeroing, return the
performance level to the level
at which it was set prior to
zeroing.
6.18
4.Press OK to accept the new setting when the console displays the “Placement Signal
Offset Adjust finished!” message.
5.The Impella® 5.0 Catheter continues running at performance level P2 and the lower
value of the differential pressure signal should display about 0±6 mmHg.
6.If the adjusted value deviates from zero by more than 6 mmHg, repeat the zeroing
procedure (steps 2-4).
7.If the adjusted value is 0±6 mmHg, slowly increase the performance level, step by step,
until you reach the setting used before the zeroing procedure.
Sensor Failure and Effects on Flow Calculations
6
If the pressure sensor fails, the console can no longer calculate the flow rate. The console will
display the flow as “?.?”.
Sensor Failure and Effects on Position Control
If the pressure sensor fails, placement monitoring is switched off because it is not possible to
display a precise position for the catheter. In this case, the motor current signal or imaging
procedures can be used for position control. As long as the motor current signal is pulsatile, .
the Impella® 5.0 Catheter is correctly positioned across the valve. This signal must be monitored
closely because the catheter can become dislodged (displaced) when moving the patient or
changing the patient’s position. Therefore, if patient hemodynamics change—for example, if
arterial pressure falls or there are signs of left ventricular failure—check the correct positioning
of the catheter using imaging procedures (eg, TEE) and the motor current signal.
Suction Detection During Sensor Drift or Sensor Failure
If sensor drift occurs or the pressure sensor fails, the console can no longer detect suction. .
(For more information about suction, refer to the “Suction” discussion earlier in this section
of the manual.) The effectiveness of Impella® 5.0 Catheter support can only be assessed by
monitoring patient hemodynamics, cardiac imaging, and the Impella® 5.0 Catheter motor
current.
Signs of suction include:
• A drop in the patient’s arterial pressure
• Decreased output, if a cardiac monitor is in place
• Decreased motor current
If imaging reveals that the suction is caused by the Impella® 5.0 Catheter inlet area in
close proximity to the ventricular wall, reposition the catheter as described in Table 6.1. If
hemodynamic parameters, such as low aortic pressure or high pulmonary artery pressure, indicate
suction caused by inadequate filling volume, reduce flow and follow the management strategies
described in Table 6.1.
6.19
Operating the Impella® 5.0 Catheter Without
Heparin in the Purge Solution
The Impella® 5.0 Catheter 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® 5.0 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® 5.0 Catheter has not been tested with any alternative anticoagulants
present in the purge solution.
How to Change to A Backup Console
A backup Impella® Console should be available at all times when a patient is on support. In the
event of a console failure, follow the steps below to transition the Impella® 5.0 System to the
backup console.
1.Confirm that the backup console is powered on and ready.
2.Transfer the pressure transducer cable from the original console to the pressure
connector socket (yellow) on the left side of the backup console.
3.Remove the blue connector cable from the original console and plug it into the catheter
connector socket (blue) located on the right side of the backup console.
4.Once the Impella® 5.0 Catheter is connected to the backup console, the “Quick Start”
message will appear on the screen asking you to confirm restarting the Impella® 5.0
Catheter at the previously set performance (P) level.
5.Press OK within 10 seconds to confirm restarting the Impella® 5.0 Catheter at the
previously set performance level.
6.20
7 Impella® Console Alarms and
Warnings
Impella® 5.0 Console Alarms................................................................. 7.1
Handling Alarms and Warnings......................................................................... 7.1
Impella® 5.0 Console Warnings............................................................7.3
Impella® 5.0 Console Alarms
7 Impella® Console Alarms and Warnings
Handling Alarms and Warnings
You can mute alarms and warnings by pressing the OK button once. The text of the alarm
or warning will remain on the display. To acknowledge receipt of the alarm or warning and
reactivate monitoring, press the OK button a second time. After muting an alarm or warning, if
another alarm or warning occurs it will only be heard and displayed if it is a higher priority alarm
or warning than the one that was muted.
Alarm Message
Battery Completely Discharged
Sudden Pump STOP Possible
Cause
Action
The battery is
depleted.
1. Immediately connect the Impella®
Console to the Impella® Power Supply
to recharge the Impella® Console
batteries.
2. Connect the Impella® Power Supply to
AC power and switch it on.
3. If the AC power icon does not appear,
change the Impella® Console.
4. Notify Abiomed.
The battery is
depleted.
1. Immediately connect the Impella®
Console to the Impella® Power Supply
to recharge the Impella® Console
batteries.
2. Connect the Impella® Power Supply
to AC power and switch it on.
3. If the AC power icon does not
appear, replace the Impella® Power
Supply and the connection cable.
4. If the alarm is still present or the AC
power icon still does not appear,
The temperature
of the Impella®
Console batteries is
dangerously high.
1. Change the Impella® Console
immediately.
2. Notify Abiomed.
Change Console Immediately!
Battery Discharged
Change Console or Connect Power Supply!
Battery Temperature too High
Keyboard not Available
Change Console!
Inform Service!
No External Pressure Signal
Check Cable and Transducer!
The Impella® Console 1. Change the Impella® Console.
keypad is defective. 2. Notify Abiomed.
The catheter can no
longer be controlled
with the Impella®
Console.
The purge pressure
measurement is
faulty.
1. Check all cables and plug connections.
2. If connections are secure, replace the
pressure transducer cable.
3. If the alarm is still present, change the
Impella® Console.
4. Notify Abiomed.
7.1
Alarm Message
No Pump Connected
Console will be Switched off
Extend for 30 minutes?
...Press OK to Confirm
Please Release ON Key!
Do NOT Use ON to Switch off!
Emergency Shut Down of Console!
Using ON May Cause Data Loss!
Pump Disconnected while Running
Check Connection!
Pump Plug Defect
Use New Pump!
Pump Stopped
Console Defect
Pump Stopped
Console Shows Last Performance Value
Confirm or Change Value!
Pump Stopped
Restart Pump!
Monitor Motor Current!
7.2
Cause
Action
No catheter has been
plugged into the
Impella® Console.
The Impella® Console
will operate for 10
minutes on battery
power and then shut
down automatically.
NOTE: The last 2
lines of this message
will appear only if
the console is on AC
power.
Plug in a catheter or switch the Impella®
Console off by pressing OK twice.
If the console is operating on AC power
you can press OK once to extend the
time to shutdown to 30 minutes.
During operation
the ON key was
pressed and held.
The Impella® Console
will turn off if the ON
key is held for longer
than 3 seconds.
Data saved on the
Impella® Console
may be lost.
Press OK to confirm the alarm message
or if the Impella® Console is off, press
ON to turn the Impella® Console on
again.
The Catheter was
disconnected
during operation
or the connection
to the catheter was
interrupted.
Check the catheter connection and all
cable and plug connections, including
power supply connections.
Error reading in
catheter data.
1. Replace the catheter.
2. Notify Abiomed.
The catheter has
stopped due to an
Impella® Console
error.
1. Change the Impella® Console
immediately.
2. Notify Abiomed.
A catheter that was
operated previously
at a performance
level greater than P0
has been plugged in
again.
1. Press OK on the Impella® Console to
restart the catheter at the previous
performance level.
2. To restart the catheter at a different
level, use the ▼ and ▲ keys to select
the desired level. Press OK to confirm.
The catheter-specific 1. Try to restart the catheter at
motor current limit
performance level P2.
has been exceeded. 2. Replace the catheter if it does not
The catheter
start up after the third attempt.
stopped. This may be
the result of electrical
or mechanical
causes.
System Error
Pump Stopped
Pump Restarted!
System Error
Pump Stopped
Restart Pump!
Time Out due to inactivity
Console will be switched off
Extend for 30 minutes?
...Press OK to Confirm
Time Out due to inactivity
Test Plug / Test Pump
Console will be switched off
Cause
Action
Alarm Message
The catheter stopped Notify Abiomed.
but is now running
again.
The catheter has
stopped due to an
error.
1. Try to restart the catheter at
performance level P2.
2. If the catheter cannot be restarted,
3. Notify Abiomed.
The pump test plug
is still in the console
but is not being used.
The console will be
switched off within 2
minutes.
NOTE: This message
will appear only if the
console is running on
AC power.
Press OK to extend the time until the
console is switched off to 30 minutes.
Otherwise, no action is necessary and
the console will be switched off in 2
minutes.
The pump test plug
No action necessary
is still in the console
but is not being used.
The console will be
switched off within 2
minutes.
NOTE: This message
will appear only if the
console is running on
battery power.
Impella® 5.0 Console Warnings
Warning Message
Console Running On Battery
Remaining Time “__” Minutes
Could not Hold Target Performance
Pump Still Running
Cause
Action
The remaining
battery capacity
is less than 50%.
The Impella®
Console displays the
estimated remaining
run-time.
1. Observe remaining run-time.
2. Be prepared to plug the console into
an AC power outlet.
1. Change the Impella® Console.
The selected
performance level
2. If the warning is still present, replace
cannot be attained.
the catheter.
The catheter is not
running at full power. 3. Notify Abiomed.
7.3
Warning Message
Data Storage not Available
Please Inform Service!
Flow Below Low Flow Limit
Check Flow Rate!
Monitor Pump Signals!
High Battery Temperature
Please Cool Console!
High Motor Current Value
Pump Still Running
Monitor Motor Current!
High Purge Pressure
Decrease Purge Rate!
Check Purge System!
Low Purge Pressure
Increase Purge Rate!
Check Purge System!
Pump has been previously used.
Use New Pump
Or press OK to continue
Pump Plug Defect
Flow Calculation not Possible
7.4
Cause
Action
The data logging
function of the
Impella® Console is
not working.
Notify Abiomed.
The flow rate has
fallen below the
low flow limit value
selected by the user.
1. If the performance level has been
reduced, adjust the low flow limit
value accordingly.
2. If attachment due to suction has
occurred, reduce the performance
level first.
The temperature of
the Impella® Console
has increased to a
dangerous level.
Move console to a cooler location.
Note: Do not place the Impella® Console
on top of the Impella® Power Supply.
The catheter has
1. Observe motor current characteristics.
mechanical problems. 2. If the current continues to increase,
The motor current
replace the catheter if possible.
limit for the selected
3. Notify Abiomed.
performance level has
been exceeded. The
catheter may stop
if the motor current
continues to increase.
The purge pressure
has increased to
greater than 700
mmHg.
1. Inspect the purge system for kinks.
2. Reduce the purge flow rate at the
infusion pump by 1 mL/h. Do not
decrease the flow rate to less than .
4 mL/h.
3. Decrease dextrose concentration.
4. If the problem persists, contact
Abiomed.
The purge pressure
1. Deliver 0.5 mL bolus until the purge
has decreased to less
pressure reaches 600 mmHg.
than 300 mmHg.
2. Inspect the purge system .
for leaks.
3. Increase the purge flow .
rate at the infusion pump .
by 0.5 mL/h. Do not exceed .
20 mL/h.
4. Refer to the Troubleshooting
discussion in section 5 of this manual
for more detailed information.
The Impella® 5.0
Catheter has been
used previously.
Use new Impella® 5.0 Catheter.
Error reading flow
rate performance
data from the red
Impella® plug.
Replace the catheter.
Pump Position Wrong
Reposition Pump!
Confirm with OK and
Cause
Action
A wrong catheter
position was
detected.
1. Reposition the catheter according to
the Repositioning Menu.
2. If step 1 does not provide correct
positioning, check the catheter
position by imaging methods.
The placement
guide was canceled
because of a fault.
A measuring signal
(placement signal) is
outside the validity
range.
1. Select the placement guide again
using the MENU key.
2. If the placement guide cancels again,
use imaging procedures as assistance
for repositioning.
Pump Repositioning Function
has been canceled
Pump Stopped
Reverse Flow!
Restart Pump!
Real Time Clock Error
Missing Time Information
Please Inform Service!
Sensor Value not Reliable
Flow Calculation not Possible
Suction Likely
Decrease Performance Slowly!
Monitor Placement Signal!
Time Out Reposition Guide Function
has been canceled
Warning Message
Retrograde flow will Unless the catheter is being explanted,
occur because the
restart the catheter immediately. Do not
catheter has stopped. restart the catheter during explantation.
The internal clock in Notify Abiomed.
the Impella® Console
is defective. Data
is being recorded
without a time
stamp.
Defective pressure
sensor or signal
interference.
1. Check the catheter position regularly
using imaging procedures and watch
for signs of suction or outlet blockage.
2. If signal interference is suspected,
either increase the distance between
Impella® 5.0 System components and
the EMI source or turn off the EMI
source.
3. If the warning is still present, refer
to “Pressure Sensor Drift and Sensor
Failure” in section 6 of this manual
for more information and consider
replacing the catheter.
The Impella® Console 1. Reduce the performance level.
has detected catheter 2. Check the filling of the left ventricle.
suction.
3. If there are no filling problems, check
the catheter for correct positioning.
4. Try to increase the performance level
to reach the intended level of support.
The placement guide If the incorrect positioning persists,
has been canceled
select the placement guide again using
because of timeout. the MENU key.
7.5
Terminology, Abbreviations, and Symbols.......................................8.1
Terminology and Abbreviations......................................................................... 8.1
Symbols............................................................................................................8.2
Ambient Conditions................................................................................ 8.3
During Operation..............................................................................................8.3
During Storage.................................................................................................8.3
Impella® 5.0 Catheter Parameters...................................................... 8.3
Impella® Console and Power Supply Parameters........................... 8.4
Connector Cable Parameters.............................................................. 8.4
Impella® 5.0 Catheter Dimensions....................................................... 8.5
Anatomic Considerations......................................................................8.6
Cleaning.....................................................................................................8.6
Storing the Impella® Console and the Power Supply.....................8.7
Returning an Impella® 5.0 Catheter to Abiomed
(United States)...........................................................................................8.7
Terminology, Abbreviations, and Symbols
Terminology and Abbreviations
Catheter serial number
Identification number of the Impella® 5.0 Catheter; stated
on the package label, on the red Impella® plug, and on the
display screen
Dextrose and Glucose
The terms “dextrose” and “glucose” are used
interchangeably to refer to the solution used as purge fluid
for the Impella® 5.0 Catheter
Hz
Hertz
Motor housing
(or pump housing)
Enclosure of the Impella® 5.0 Catheter motor
Pump
Central delivery unit of the Impella® 5.0 Catheter, consisting
of the motor, motor housing, cannula with inlet and outlet,
and pigtail at the tip
Pump test plug
Tool required for checking functions during preventive
maintenance; thick metal plug marked “Pump Test Plug”
Purge pressure
Pressure present in the purge lumen within the Impella® 5.0
Catheter and in the purge tubing
Purge system
Infusion pump used for rinsing the Impella® 5.0 Catheter
Retrograde flow
Reverse flow through the cannula when the Impella® 5.0
Catheter is at a standstill (eg, regurgitation)
V
Volt
VA
Volt ampere (Watt)
8.1
Symbols
Caution; comply with instructions for use
Defibrillator-proof type CF equipment
Keep dry
Storage temperature (eg, 10°C to 30°C)
Declares conformity with directive 93/42/EEC for medical
devices
2009-02
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
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
Ambient Conditions
8 Impella® Console
Max. temperature
40°C (104°F)
Min. temperature
10°C (50°F)
Max. rel. atmospheric humidity
75%
General System Information
During Operation
Ambient conditions that prevail
within the human body
During Storage
Impella® Console
Max. temperature
40°C (104°F)
25°C (77°F)
Min. temperature
10°C (50°F)
10°C (50°F)
Max. rel. atmospheric humidity
75%
75%
Impella® 5.0 Catheter Parameters
Speed range
0 to 33,000 rpm
Power consumption
Less than 1.07 W
Voltage
Max. 18 V DC
Flow-Maximum
5.0 L/min
Purging the Impella® 5.0 Catheter
Recommended purge fluid.
Dextrose concentration
Purge pressure
Infusion rate
Maximum duration of use
US
Reliability
20% dextrose solution with heparin concentration
of 50 IU per mL
5% to 40%
300 to 700 mmHg
4 to 20 mL/h
6 hours
91.4% with 80% confidence at 10 days based on
chi-squared test
Latex Free
All versions of the Impella®
System, including all
accessories, are latex free.
Dimensions of Impella® 5.0 Catheter
Length of invasive portion (without catheter) 140 ± 3 mm
Diameter
Max. 7.2 mm (nom. 7.0 mm)
Classification per DIN EN 60601-1
Protection class II, degree of protection: .
CF (Impella® Console and Impella® 5.0 Catheter)
Classification per directive 93/42/EEC
Class III
Latex free
Yes
8.3
Impella® Console and Power Supply Parameters
Accuracy of calculated flow rates
± 10% (relative to maximum flow rate)
Characteristic values
Nominal voltage
Max. nominal current under load
Max. power consumption under load
Device fuse
Running time without power supply with
fully charged batteries
110/230 V (at 50/60 Hz)
1.1 A
120 VA
2x2 A slow-blow
At least 60 minutes (charging duration of at least
10 hours)
Classification per DIN EN 60601-1
Safety Class II, degree of protection: CF
Classification per directive 93/42/EEC
Class IIb
Electrical system
Installation in accordance with pertinent
regulations is required for use in medical facilities
(eg, VDE 0100, VDE 0107, or ICE stipulations).
Observe country-specific regulations and national
deviations.
Electromagnetic compatibility
Tested in accordance with DIN EN 60601-1-2
Impella® Console dimensions
Height
Width
Depth
Weight
55 mm
260 mm
305 mm
3.35 kg (7.38 lbs.)
Impella® Power Supply dimensions
Height
Width
Depth
Weight
75 mm
305 mm
265 mm
3.2 kg (7.0 lbs.)
Maintenance and repair interval
12 months
(Work must be performed by technicians
authorized by Abiomed)
Connector Cable Parameters
8.4
Length
2.5 m
Service life
Single use only
Impella® 5.0 Catheter Dimensions
6 Fr
9 Fr
35-45 cm
Length of
sterile sleeve
21 Fr
10 cm
Repositioning
sheath
97 cm
Differential
pressure
sensor
3.5 cm
8 cm
11.5 cm
Figure 8.1 Impella® 5.0 Catheter Dimensions
14 cm
8.5
Anatomic Considerations
In a small number of cases (about 2 in every 100 patients) the Impella® 5.0 Catheter cannot
be successfully placed; or can be placed, and the performance is compromised due to patients
having anatomic conditions outside of the range for which the Impella® 5.0 Catheter was
designed.
The following table describes anatomic conditions that may affect the insertion or operation of
the Impella® 5.0 Catheter. Physicians should consider these characteristics when evaluating small
or very tall patients for Impella® 5.0 Catheter support.
Condition
Effect
The size and tortuosity of the
femoral and iliac arteries
Limits the ability of the Impella® 5.0 Catheter to be advanced
from the insertion site into the left ventricle
Distance from the insertion site
to the apex of the left ventricle
For very tall patients, the maximum interventional length may
not be sufficient to allow correct placement of the Impella® 5.0
Catheter
Systolic left ventricular (LV) long The Impella® 5.0 Catheter may interfere with the mitral valve
axis < 7 cm
Systolic left ventricular (LV) long The Impella® 5.0 Catheter pigtail will not have a surface to push
axis > 11 cm
against to help stabilize its position, and may have a tendency to
swing or bounce
Cleaning
• Clean the Impella® Console, the pump test plug, and the cables by wiping them down
with disinfectant.
• Do not allow any fluids to enter the connector sockets.
8.6
• Place the Impella® Console on a horizontal surface to prevent falling.
• Connect the AC power cable from the Impella® Power Supply to an AC outlet.
• The battery may be destroyed if the Impella® Console is stored with a depleted battery.
To keep the Impella® Console
battery charged, the console
should be plugged into the
Impella® Power Supply. The
Impella® Power Supply should
be plugged into an AC outlet
and switched to the ON
position when it is stored.
Both the green POWER and
CONNECTED lights should
be lit.
(United States)
To return an Impella® 5.0 Catheter to Abiomed, contact your local Clinical Consultant for
an Abiomed-approved return kit.* The kit includes instructions for returning the catheter to
Abiomed.
* Only available in the United States
8.7
General System Information
Storing the Console
8 Storing the Impella® Console and the Power
Supply
Appendices
Appendix A: Impella® System Limited Service Warranty
(United States)................................................................... A.1
Appendix B: Technical Safety Inspections, Maintenance,
and Repair...........................................................................B.1
Technical Safety Inspections............................................................................. B.1
Maintenance and Repair Intervals..................................................................... B.1
Impella® Console Function Test.........................................................................B.2
Appendix A
Appendix A: Impella® System Limited Service
Warranty (United States)
Abiomed, Inc. warrants that, at the time of installation, all Impella® Systems (the “Goods”) sold will
be free from defects in material and workmanship and remain free from defects under normal use .
and service for a period of one (1) year from the date of shipment. Extended warranty and service may,
at Abiomed's option, be offered for an additional charge, in which event separate or additional terms
and conditions may apply. This warranty provides coverage for the Impella® Console, Power Supply, and
Purge System.
This warranty does not cover routine preventive maintenance or replacement parts that are consumed per
the console’s periodic maintenance schedule outlined in the Operator’s and Service Manuals.
The express warranty set forth on this page is the only warranty given by Abiomed with
respect to any goods furnished hereunder. Abiomed makes no other warranty, express,
implied or arising by custom or trade usage, and specifically makes no warranty of
merchantability or of fitness for any particular purpose. Said express warranty shall not
be enlarged or otherwise affected by Abiomed's rendering of technical or other advice or
service in connection with the Goods.
Abiomed shall not be liable for incidental or consequential losses, damages or expenses, directly or
indirectly arising from the sale, handling or use of the Goods, or from any other cause relating thereto,
and Abiomed's sole responsibility under this warranty will be, at its option, to 1) repair or replace the
Goods or any components of the Goods found to be defective in workmanship or material during the
foregoing warranty period, or 2) to refund the purchase price paid. All replaced components and Goods
will become the property of Abiomed. This warranty shall not apply if the Goods have been: (a) repaired
or altered in any way by other than Abiomed or Abiomed authorized service personnel; (b) subjected
to physical or electrical abuse or misuse; or (c) operated in a manner inconsistent with Abiomed's
instructions for use of the Goods. If Abiomed determines that a claim was not caused by Abiomed .
or Abiomed’s authorized service personnel, then Buyer shall pay Abiomed for all related costs incurred by
Abiomed. This warranty is not transferable without the express written consent of Abiomed.
Under this warranty, Abiomed will provide at no charge, updates or modifications which directly affect
the safe operation of the Goods. Abiomed is not obligated to provide updates or modifications which
provide (a) product improvement or enhancement; (b) new product features, or (c) options to the Goods.
Abiomed has no obligation to provide a loaner system during service or maintenance of the Goods.
However, at Abiomed’s sole discretion, Abiomed may provide such loaner systems.
This warranty applies to the Impella® System only (Console, Power Supply, and Purger) and not to any
disposable or other component of the Impella® System. Specific items excluded from this warranty
include, but are not limited to, pumps, external tubing and accessories.
This warranty may not be amended without the express written consent of an authorized officer of
Abiomed.
A.1
Appendix B
Appendix B: Technical Safety Inspections,
Maintenance, and Repair
Technical Safety Inspections
In accordance with the specification issued by Abiomed as per §6 MPBetreibV (German
regulation), the Impella® Console must be subject to yearly technical safety inspections.
Technical safety inspections may only be carried out by authorized technicians in accordance
with the technical safety inspection requirements presented below and must be documented .
in the medical product logbook in accordance with §7 MPBetreibV.
A sticker on the device indicates the date for the next required inspection. Figure B.1 shows
a sticker indicating that inspection is required in May 2010. However, the stipulations in the
medical product logbook are binding in any case.
Figure B.1 Inspection Sticker Showing Inspection Required in May 2010
The following technical safety inspections are required for the Impella® System:
• Inspection of labeling and instructions for use
• Visual inspection of the device and its accessories for any signs of damage
• Testing for electrical safety as per DIN VDE 751 or DIN EN 60 601
• Leakage current test
• Dielectric strength test
• Functional testing of all switches, keys, rotary knobs, sockets, and control lights on the device
• Checking battery operation
If defects become apparent during the technical safety inspections that could endanger patients,
employees, or third parties, then the device must not be operated until the defects have been
remedied by proper technical servicing.
Maintenance and Repair Intervals
The Impella® Console is subject to 1 year maintenance and repair intervals. The corresponding
work must be performed by technicians authorized by Abiomed, and must be documented in the
medical product logbook in accordance with §7 MPBetreibV (German regulation).
B.1
Impella® Console Function Test
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.
As part of preventive maintenance, it may be necessary to perform an Impella® Console function
test using the pump test plug.
1.Insert the pump test plug, with the “up” marker oriented upward, into the catheter
connector socket at the right side of the Impella® Console handle. A single beep
followed by a series of three beeps confirms insertion. The Impella® Console displays
the Impella® Console information screen (see Figure B.2).
P-Perf
P0
LV0
98%
Flow [L/min]
?.?
50
50
Information
Pump: Testplug
Pump ID: 0
MPC: 01.203-xx.xxx
10 s
Figure B.2 Impella® Console Information Screen
2.Confirm that the following items are displayed (see Figure B.2):
• P-Perf: P0
• Pump: Testplug
• Pump ID: 0
• Flow (L/min): ?.?
• Pressure value of 50 (± 4) mmHg (above the right diagram axis)
Returning to P0
To return to performance
level P0, press the P-PERF key
until two blinking vertical bar
graphs appear next to the
performance level display. Set
the performance level to P0
by pressing ▼ and OK.
B.2
3.Press the SIGNAL key three times to open the speed screen (Speed [RPM]).
4.Press and hold the P-PERF key until two blinking vertical bar graphs appear next to
the P0 display.
5.Set the performance level to P5 by pressing ▲ and acknowledging within 10 seconds by
pressing OK. Confirm that the speed lies within the range of 23,000 to 25,000 rpm.
6.Return the performance level to P0 by pressing P-PERF, ▼ and OK before the pump
test plug is removed.
7.Remove the pump test plug. The Impella® Console function test is now complete.
INDEX
A
Abbreviations (See Terminology and abbreviations)
Activated clotting time (ACT)
ACT for catheter insertion with GP IIb-IIIa inhibitor,
5.10
ACT for catheter insertion with heparin, 5.10
Maintaining ACT until explant, 5.11
Adverse events (potential), 2.1
Alarms
Console alarms, 7.1
Downstream occlusion
(figure), 5.20
Handling alarms and warnings, 7.1
High purge pressure, 5.18
(figure), 5.18
Low purge pressure, 5.15
(figure), 5.15
Understanding and managing position alarms,
6.11 (See also Patient management:
Understanding and managing Impella® 5.0
Catheter position alarms)
B
B. Braun Vista basic Infusion Pump (See also Purge
system)
Features
Alarm light, 3.10
(figure), 3.10
Alarm silence key, 3.10
(figure), 3.10
Clear key, 3.10
(figure), 3.10
Display screen, 3.10
(figure), 3.10
Function keys, 3.10
(figure), 3.10
Infusion light, 3.10
(figure), 3.10
Keypad, 3.10
(figure), 3.10
ON/OFF key, 3.10
(figure), 3.10
START/STOP key, 3.10
(figure), 3.10
Replacing the purge tubing, 5.14
Troubleshooting (See Purge system:
Troubleshooting)
C
Catheter (See also Diagnostic catheter)
Catheter components, 3.3
Cannula, 3.3
(figure), 3.3
Catheter shaft, 3.4
(figure), 3.3
Check valve, 3.4
(figure), 3.3
Clear sidearm, 3.4, 5.4
(figure), 3.3
Differential pressure sensor, 3.4 (See
also Catheter: Differential pressure sensor)
(figure), 3.3
Infusion filter, 3.4
(figure), 3.3
Inlet area, 3.3
(figure), 3.3
Motor housing, 3.4
(figure), 3.3
Outlet area, 3.4
(figure), 3.3
Pigtail, 3.3
(figure), 3.3
Pressure reservoir, 3.4
(figure), 3.3
Red Impella® plug, 3.4
(figure), 3.3
Memory, 3.4
Repositioning unit, 3.4
(figure), 3.3
Description, 3.3
(figure), 3.3
Differential pressure sensor, 3.4 (See
also Catheter: Catheter components: Differential
pressure sensor)
Electrical signal generated by cardiac cycle
(figure), 3.5
(figure), 3.5
Flat placement signal
(figure), 3.6
Pressure sensor drift, 6.18, 6.19
Pulsatile placement signal
(figure), 3.6
Sensor failure, 6.18, 6.19
Dimensions, 8.5
Kinking, 5.4, 5.18
Position alarms (See Patient management:
(US), 8.7
Using the catheter (See also Impella® 5.0 System:
Using the system)
Inserting the catheter, 5.9
(figure), 5.9, 5.10
Positioning and starting the catheter, 5.12
(figure), 5.12, 5.13
Post-insertion positioning (PIP) checklist
, 6.11
Preparing the catheter, 5.4
(figure), 5.4, 5.5
Catheter serial number, 4.6, 8.1
(figure), 4.5
Cautions, 1.2
Combitrans-Monitoring Set (CM-Set)
Description, 3.11
(figure), 3.11
Replacing the CM-Set, 5.14
Connector cable
Connecting the connector cable, 5.4
Connecting to the Impella® 5.0 Catheter
(figure), 5.4
Connecting to the Impella® Console
(figure), 5.5
Description, 3.11, 8.4
(figure), 3.11
Disconnecting connector cable from console, 5.21
(figure), 5.21
Snapping plastic clip to connector cable
(figure), 5.5
Console
Alarms, 7.1
Battery power, 3.7, 4.10
Changing to a backup console (See Patient
management: How to change to a backup
console)
Cleaning the console, 8.6
Connections
Catheter connector socket
(figure), 4.2
Power supply connector, 4.4
(figure), 4.2
Pressure connector socket, 4.4
(figure), 4.2
Console information, 4.3
Console parameters, 8.4
Description, 3.7, 4.1
(figure), 3.7, 4.2
Display elements
AC power icon, 4.5
(figure), 4.5
Battery status information, 4.5
(figure), 4.5
Catheter operation icon, 4.5
(figure), 4.5
Catheter type and serial number, 4.6
(figure), 4.5
Flow rate, 4.5
(figure), 4.5
Information and waveform display, 4.6
(figure), 4.5
Low flow alarm limit icon, 4.5
(figure), 4.5
Performance level, 4.5
(figure), 4.5
Signal bar graph, 4.6
(figure), 4.5
Signal numeric readout, 4.6
(figure), 4.5
Time window display, 4.6
(figure), 4.5
Type of signal selected, 4.5
(figure), 4.5
Display screen
(figure), 4.2
Dual signal screen, 4.3, 4.8
(figure), 4.8, 5.13
Flow rate screen, 4.3, 4.10
(figure), 4.10
Function keys, 4.2
▲ and ▼ keys, 4.3, 7.2
(figure), 4.2
FLOW key, 4.3
MENU key, 4.3
OK key, 4.3
ON key, 4.4
P-PERF key, 4.3
SCALE key, 4.4
SIGNAL key, 4.3
ZERO key, 4.3
Information screen
(figure), B.2
Mobile operation, 4.10
Motor current screen, 4.3, 4.9
(figure), 4.9
Placement monitoring screen, 4.3, 4.7
(figure), 4.7
Placement signal screen, 4.3, 4.7
(figure), 4.7
Initial placement signal
(figure), 5.12
Placement signal as catheter crosses the aortic
valve
(figure), 5.12
I.1
INDEX
Purge pressure screen, 4.3, 4.8
Abnormal purge pressure on 5 minute scale
screen
(figure), 5.17
(figure), 4.8
Normal purge pressure on 5 minute scale screen
(figure), 5.16
Speed screen, 4.3, 4.9
(figure), 4.9
Storage, 8.7
Console function test (See Impella® 5.0 System:
Using the system: Console function test)
Contraindications, 2.1
D
Dextrose, 8.1 (See also Dextrose solution)
Dextrose solution
Amount of dextrose delivered in purge fluid, 5.19
Description, 3.12, 5.1, 8.1
(figure), 3.12
Dextrose and heparin infusion rates, 5.16
Heparin, 3.12 (See also Patient management:
Operating the Impella® 5.0 without heparin in
the purge solution)
Diagnostic catheter
AL1, 5.10
Multipurpose (MP), 5.10
Dual signal (See Console: Dual signal screen;
See Patient management: Understanding and
managing Impella® 5.0 position alarms)
E
ECG interference (See Patient management: ECG
interference)
Echocardiography
Color Doppler, 6.10
(figure), 6.10
Transesophageal (TEE), 6.3, 6.4
(figure), 6.5, 6.8
Transthoracic (TTE), 6.3, 6.4
(figure), 6.5, 6.9, 6.10
Explant (See Patient management: Guidelines for
explant)
F
Flow rate (See also Console: Flow rate screen)
Accuracy of displayed flow rate, 6.18
Effects of sensor drift, 6.18
Expected flow rate displayed on console, 6.18
Fluoroscopy, 5.9, 6.3 (See also Patient management:
Positioning and placement devices)
Function test (See Impella® 5.0 System: Using the
system: Console function test)
G
Glucose, 8.1 (See also Dextrose solution)
GP IIb-IIIa inhibitors, 5.10
Guidewires (See also Impella® 5.0 System: Using the
system: Inserting the catheter)
0.025 inch, 260 cm placement guidewire, 3.12
(figure), 3.12
H
Hemolysis (See Patient management: Hemolysis)
Heparin (See also Patient management: Operating
the Impella® 5.0 Catheter without heparin in the
purge solution)
Amount of heparin delivered in purge fluid, 5.19
Heparin and dextrose infusion rates, 5.16
High purge pressure (See Purge system:
Troubleshooting)
I.2
I
Impella 5.0 Catheter (See Catheter)
Impella® 5.0 Catheter dimensions, 8.5
Impella® 5.0 Power Supply (See Power Supply)
Impella® 5.0 System
Abbreviations, 8.1
Anatomic considerations, 8.6
Cleaning, 8.6
General system information
Abbreviations, 8.2
Ambient conditions, 8.3
Anatomic considerations, 8.6
Cleaning, 8.6
Connector cable parameters, 8.4
Impella® 5.0 Catheter dimensions, 8.5
Impella® 5.0 Catheter parameters, 8.3
Impella® 5.0 Console parameters, 8.4
Impella® 5.0 Power Supply parameters, 8.4
(US), 8.7
Storing the Impella® Console, 8.7
Storing the Impella® Power Supply, 8.7
Terminology, 8.1
Impella® 5.0 Catheter parameters, 8.3
Maintenance and repair intervals, B.1
Overview, 3.1
(figure), 3.1
Preventive maintenance
Console function test, B.2
(US), 8.7
Reusable components, 3.1 (See also Console; See
also Power Supply; See also Pressure transducer
cable; See also Pump test plug; See also Purge
system)
Single-use components, 3.2 (See also Catheter;
See also Combitrans-Monitoring Set; See
also Connector cable; See also Guidewires:
0.025 inch, 260 cm placement guidewire; See
also Purge system: Purge tubing)
Storage, 8.7
Symbols, 8.2
System configuration
(figure), 3.2
System specifications (See Impella® 5.0 System:
General system information)
Technical safety inspections, B.1
(figure), B.1
Terminology, 8.1
Using the system
Checking Impella® Power Supply function, 5.2
Connecting pressure transducer cable
(figure), 5.6
Connecting the CM-Set to the catheter
(figure), 5.7
Connecting the connector cable, 5.4
(figure), 5.5
Connecting the power supply cable
(figure), 5.2
Connecting the pressure transducer cable, 5.6
Console function test
(figure), B.2
Disconnecting connector cable from console,
5.21
(figure), 5.21
Flush purge line and purge lumen screen
(figure), 5.7
®
Inserting the catheter, 5.9
(figure), 5.9, 5.10
Maintaining ACT, 5.11
Placing the Impella® Power Supply next to the
Impella® Console
(figure), 5.1
Positioning aids and other displays, 4.7
Positioning and starting the catheter, 5.12 (See
also Echocardiography; See also Fluoroscopy)
(figure), 5.12, 5.13
Post-insertion positioning (PIP) checklist, 6.11
Preparing the catheter, 5.4
(figure), 5.4, 5.5
Preparing the purge fluid, 5.3
Priming the Impella® 5.0 Catheter purge lumen,
5.7
(figure), 5.8
Ready to insert screen
(figure), 5.8
Selecting performance level, 4.6
Startup, 5.1
Equipment set-up, 5.1
Supplies needed, 5.1
Turning Power Supply on
(figure), 5.2
Turning the console off, 4.4
Turning the console on, 4.4
Zeroing the differential pressure sensor, 6.18
Warranty (See Warranty)
Weaning, 5.20
Rapid weaning, 5.20
Slow weaning, 5.21
Impella® Console (See Console)
Indications, 2.1
L
Language selection, 4.3
Latex (See Patient management: Latex)
Low purge pressure (See Purge system:
Troubleshooting)
M
Maintenance and repair intervals (See Impella® 5.0
System: Maintenance and repair intervals)
Motor current (See Console: Motor current screen;
See Patient management: Understanding and
managing Impella® 5.0 Catheter position alarms)
P
Patient management
ECG interference, 6.3
Echocardiography for positioning catheter,
6.4 (See also Echocardiography)
General patient care considerations, 6.1
Hemolysis, 6.16
Guide for managing hemolysis, 6.17
How to change to a backup console, 6.20
Latex, 6.3
Operating the Impella® 5.0 Catheter without
heparin in the purge solution, 6.20
Overview, 6.1
Positioning and placement devices, 6.3
Right heart failure, 6.2
Suction, 6.16, 6.19
Transport within the hospital, 6.2
Catheter position alarms, 6.11
INDEX
Correct catheter position, 6.12
(figure), 6.12
Impella® 5.0 Catheter fully in aorta, 6.13
(figure), 6.13
Impella® 5.0 Catheter outlet area on or near
aortic valve, 6.15
Impella® 5.0 fully in ventricle, 6.13
(figure), 6.13
Low native heart pulsatility, 6.14
(figure), 6.14
Performance level
Flow rates, 4.6
Selecting performance level, 4.6
Placement monitoring (See Console: Placement
monitoring screen; See Patient management:
Placement signal (See Console: Placement signal
screen)
Plasma-free hemoglobin (PfHgb), 6.16
Post-insertion positioning (PIP) checklist, 6.11
Power Supply (See also Power Supply cable)
Checking Impella® Power Supply function, 5.2
Description, 3.8
(figure), 3.8
Impella® Power Supply parameters, 8.4
Indicator lights
CAN light, 3.8
(figure), 3.8
CONNECTED light, 3.8
(figure), 3.8
POWER light, 3.8
(figure), 3.8
Rear panel
AC power connector, 3.9
(figure), 3.9
CAN-bus interface, 3.9
(figure), 3.9
Fuses, 3.9
(figure), 3.9
Impella® Console connector, 3.9
(figure), 3.9
Power switch, 3.9
(figure), 3.9
Storage, 8.7
Turning Impella® Power Supply on
(figure), 5.2
Power Supply cable (See also Impella® 5.0 System:
Using the system)
Connecting Impella® Power Supply cable to console
(figure), 5.2
Connecting Impella® Power Supply cable to power
supply
(figure), 5.2
Description, 3.9
(figure), 3.9
Pressure sensor drift (See Catheter: Differential
pressure sensor)
Pressure transducer cable
Connecting the cable to the console, 5.6
(figure), 5.6
Description, 3.11
(figure), 3.11
Pump, 8.1
Pump housing, 8.1
Pump test plug
Cleaning the pump test plug, 8.6
Definition, 8.1
Description, 3.12
(figure), 3.12
Use in console function test, B.2
Purge fluid (See Impella® 5.0 System: Using the
system: Preparing the purge fluid)
Purge pressure (See Console: Purge pressure screen;
See Purge system: Troubleshooting)
Definition, 8.1
Preventing kinking, 5.5
Purge pressure management strategies, 5.19
(figure), 5.19
Purge system
Description, 3.10 (See also B. Braun Vista basic
Infusion Pump)
(figure), 3.10
Preventing kinking, 5.4
Producing the bolus, 5.7
Purge tubing, 3.12
(figure), 3.12
Stopping the bolus, 5.7
Troubleshooting, 5.15
Dextrose delivered in purge fluid, 5.19
Downstream occlusion, 5.20
(figure), 5.20
Heparin in purge fluid, 5.19
High purge pressure, 5.18
(figure), 5.18
Low purge pressure, 5.15
(figure), 5.15
Purge pressure management strategies, 5.19
W
Warnings
Console warnings, 7.3
High purge pressure
(figure), 5.18
Low purge pressure
(figure), 5.15
System warnings, 1.1
Warranty
Impella® System Limited Service Warranty (US), A.1
Weaning (See also Impella® 5.0 System: Weaning)
X
X-ray
Use in Impella® 5.0 Catheter positioning, 6.3
Z
Zeroing the differential pressure
sensor (See Impella® 5.0 System: Using the
system: Zeroing the differential pressure sensor)
R
Repositioning Guide, 4.3
Retrograde flow, 4.6, 8.1
(US), 8.7
Right heart failure (See Patient management: Right
heart failure)
S
Speed (See Console: Speed screen)
Suction (See Patient management: Suction)
Symbols, 8.2
T
Terminology and abbreviations, 8.1
Test plug (See Pump test plug)
Transesophageal echocardiography (TEE), 6.3,
6.4 (See also Echocardiography)
Transport within the hospital (See Patient
management: Transport within the hospital)
Transthoracic echocardiography (TTE), 6.3, 6.4 (See
also Echocardiography)
V
Vista basic Infusion Pump (See B. Braun Vista basic
Infusion Pump)
I.3
Clinical support 24 hours per day, 7 days a week: 1-800-422-8666 (US) +49 (0) 1805 2246633 (EU)
www.abiomed.com
Abiomed, Inc.
22 Cherry Hill Drive
Danvers, Massachusetts 01923 USA
Voice: 978-777-5410
Facsimile: 978-777-8411
Email: clinical@abiomed.com
Abiomed Europe GmbH
Neuenhofer Weg 3
52074 Aachen, Germany
Voice: +49 (241) 8860-0
Facsimile: +49 (241) 8860-111
Email: europe@abiomed.com

Impella® 5.0

Transcription

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