Abiomed Impella 5.5 User manual

USER MANUAL
BENUTZERHANDBUCH
MANUALE D‘USO
MANUEL D‘UTILISATION
UŽIVATELSKÁ PŘÍRUČKA
Impella 5.5®
with SmartAssist®
Circulatory Support System

TABLE OF CONTENTS
English............................................................................................................... 1
Deutsch ........................................................................................................... 17
Italiano ............................................................................................................ 35
Français ........................................................................................................... 53
Česky............................................................................................................... 69

1
Impella 5.5®with SmartAssist®Circulatory Support System
INTENDED AUDIENCE
This Instructions for Use and Clinical Reference Manual is designed for healthcare professionals. It contains clinical and technical information to guide healthcare
professionals in their use of the Impella 5.5®with SmartAssist®. To use the system you must understand and follow these instructions. The Impella 5.5 with
SmartAssist may be used only for its intended purpose.
WARNINGS
Warnings alert you to situations that can cause death or serious injury.
The dark gray symbol appears before warning messages.
Use of the Impella®System by trained and experienced practitioners
has been associated with improved outcomes. Consequently, the first
use of Impella should be preceded by the completion of a contemporary
Abiomed Impella training program and include on-site proctoring
during the first use by Abiomed clinical support personnel certified in
the use of Impella.
Fluoroscopy is required for the insertion of the Impella guidewire and
Impella 5.5 with SmartAssist Catheter.
During insertion, avoid manual compression of the inlet, outlet, or
sensor areas of the cannula assembly on the Impella 5.5 Catheter.
The sterile components of the Impella 5.5 System can be used only if
the packaging is not damaged, and the expiration date has not elapsed.
Do NOT resterilize or reuse the Impella 5.5 with SmartAssist 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 5.5 with
SmartAssist Catheter is set at P-level P-0.
Do NOT use saline in the purge system.
Do NOT use alcohol-based fluids for lubrication.
Do NOT use an Impella 5.5 with SmartAssist System if any part of the
system is damaged.
To prevent the risk of explosion, do NOT operate the Impella 5.5 with
SmartAssist System near flammable anesthetics.
If at any time during the course of support with the Impella 5.5 with
SmartAssist Catheter, the Automated Impella Controller alarms “Purge
Pressure Low” or “Purge System Open,” follow the instructions
presented in this manual.
MR Unsafe - Do NOT subject a patient who has been
implanted with an Impella 5.5 with SmartAssist Catheter to
magnetic resonance imaging (MRI). The strong magnetic
energy produced by an MRI machine may cause the Impella 5.5
System components to stop working, and result in injuries to the patient.
An MRI may also damage the electronics of the Impella 5.5 System.
During defibrillation, do NOT touch the Impella 5.5 with SmartAssist
Catheter, cables, or Automated ImpellaController.
Avoid overinserting the Impella 5.5 Catheter and possibly impinging the
catheter tip against the walls of the vasculature or ventricles.
Do NOT advance or withdraw the Impella 5.5 with SmartAssist
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.
CAUTIONS
Cautions indicate situations in which equipment may malfunction, be
damaged, or cease to operate. The light gray symbol appears before
caution messages.
INTENDED USE (EU)
INTENDED USE IN THE EUROPEAN UNION
The Impella 5.5®with SmartAssist®heart pump is an intracardiac pump for
supporting the left ventricle. It is intended for clinical use in cardiology and
in cardiac surgery for up to 30 days for the following indications, as well as
others:
• The Impella 5.5 with SmartAssist is a cardiovascular support system
for patients with reduced left ventricular function, e.g., post-
cardiotomy, low output syndrome, cardiogenic shock after acute
myocardial infarction.
• The Impella 5.5 with SmartAssist may also be used as a cardiovascular
support system during coronary bypass surgery on the beating heart,
particularly in patients with limited preoperative ejection fraction with
a high risk of postoperative low output syndrome.
Handle with care. The Impella 5.5 with SmartAssistCatheter 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 5.5 with SmartAssist
Catheter. Patients with aortic valve disease should be observed for aortic
insufficiency.
Use only original accessories and replacement parts supplied by
Abiomed.
To prevent device failure, do NOT start the Impella 5.5 with SmartAssist
Catheter until the placement guidewire has been removed.
Do NOT remove the Impella 5.5 with SmartAssist Catheter over the
length of the placement guidewire.
When replacing the purge cassette, the replacement process must be
completed within 90 seconds. TheImpella 5.5 with SmartAssist Catheter
may be damaged if replacement takes longer than 90 seconds.
Do NOT kink or clamp any part of the Impella 5.5 with SmartAssist
Catheter.
Have a backup Automated Impella Controller, purge cassette, and
Impella 5.5 with SmartAssist Catheter available in the unlikely event of a
device failure.
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User Manual
2
CONTRAINDICATIONS (EU)
CONTRAINDICATIONS IN THE EUROPEAN UNION
The Impella 5.5®with SmartAssist®heart pump is contraindicated for the
following situations:
• Mechanical aortic valves, severe aortic valvular stenosis
• Hematological disorder causing fragility of the blood cells or hemolysis
• Hypertrophic obstructive cardiomyopathy (HOCM)
• Aneurysm or necrotomy or severe anomaly of the ascending aorta
and/or the aortic arch
• Mural thrombus in the left ventricle
• Ventricular septal defect (VSD) after myocardial infarction
• Anatomic conditions precluding insertion of the pump
POSSIBLE COMPLICATIONS (EU)
There are risks of complications with every procedure using a blood pump.
These include among others:
• Hemolysis
• Bleeding
• Immune reaction
• Embolism, thrombosis
• Vascular injury through to angionecrotomy
• Positioning problems causing haemolysis or reduced
haemodynamic support
• Infection and septicemia
• Dislocation of the pump
• Cardiovalvular injuries due to extreme movement of the suction
cannula in relation to the cardiac valve or as a result of attachment
by suction of the pump to the valve system following incorrect
positioning
• Endocardiac injuries as a result of attachment of the pump due to
suction
• Pump failure, loss of pump components following adefect
• Patient dependency on the pump after use for support
OVERVIEW
The Impella 5.5 Catheter is an intravascular microaxial blood pump that
supports a patient’s hemodynamic system. The Impella 5.5 Catheter is
inserted via axillary artery cut-down through the artery and into the left
ventricle. The Impella 5.5 Catheter may also be surgically inserted when
there is access to the ascending aorta through a sternotomy or thoracotomy.
When properly positioned, the Impella 5.5 Catheter delivers blood from
the inlet area, which sits inside the left ventricle, through the cannula, to
the outlet opening in the ascending aorta. Physicians and device operators
monitor the correct positioning and functioning of the Impella 5.5 Catheter
on the display screen of the Automated Impella Controller.
This section describes the components of the Impella®Catheter and the
Automated Impella Controller, as well as the accessory components.
REUSABLE SYSTEM COMPONENTS
The Impella 5.5 System consists of the following reusable components:
• Automated Impella Controller—provides the user interface, alarm
indications, and portable battery
• Automated Impella Controller cart—for easy transport of the
Automated Impella Controller
SINGLE-USE SYSTEM COMPONENTS
The Impella 5.5 with SmartAssist System also includes the following single-
use components:
• Impella 5.5 with SmartAssist Catheter
• Purge cassette
• 0.018 inch, 260 cm placement guidewire
• Impella Axillary Insertion kit
• Silicone Plugs
• Incision template
SYSTEM CONFIGURATION
IMPELLA 5.5®WITH SMARTASSIST®
CATHETER
The Impella 5.5 with SmartAssist Catheter is an intravascular microaxial
blood pump that delivers up to 5.5 liters of blood per minute from the left
ventricle into the aorta.
Purge
Fluid
Automated Impella
Controller (AIC)
Impella 5.5
Catheter
Integrated
Patient Cable
Purge Cassette
Glucose/ Dextrose
GLUCOSE
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Impella 5.5®with SmartAssist®Circulatory Support System
PURGE CASSETTE
Do not use saline in the purge system.
The purge cassette delivers rinsing fluid to the Impella 5.5®with SmartAssist®
Catheter. The purge fluid (typically 5% glucose solution in water with heparin)
flows from the purge cassette through the catheter to the microaxial blood
pump to prevent blood from entering the motor.
Purge Disc
Yellow Luer
Connector
Purge Tubing
Supply Line
Purge
Cassette
Purge Fluid Spike
ACCESSORIES
The 0.018 inch, 260 cm guidewire is
used for the placement of the Impella 5.5
Catheter. The guidewire has a radiopaque,
shapable tip.
These alternative guidewires have been
tested and approved for use with the
Impella System: Boston Scientific Platinum
Plus™ ST 0.018 in, and Boston Scientific
V-18 Control Wire™ ST 0.018 in.
The Impella Axillary Insertion kit facilitates
placement of the Impella 5.5 Catheter
via the axillary artery. It contains a 23
Fr diameter x 6 cm length peel-away
introducer and two (2) graft locks used to
attach a graft onto the introducer. (Note:
Only one graft lock is required when used
with the recommended Hemashield™
Platinum graft; a back-up is provided.)
The kit is packaged with an 8 Fr
silicone-coated lubrication dilator. It is
recommended to be used in conjunction
with a 10 mm diameter x 20 cm length
Hemashield Platinum graft.
The incision template is used to assist
in correct placement of the Impella 5.5
Catheter during direct aortic insertion
by indicating the correct location for the
incision in the ascending aorta.
The two silicone plugs can be placed around
the catheter shaft to help control bleeding
during and after Impella 5.5 Catheter
insertion.
Hospital Provided:
Solution (typically 5% glucose in water
with 25 or 50 IU/mL of heparin) is used
as the purge fluid through the Impella 5.5
Catheter.
The Automated Impella Controller cart
holds the Automated ImpellaController. The
cart has wheels for easy transport of the
controller and a storage basket. (For more
information, including assembly instructions,
refer to the Automated Impella Controller
cart instructions for use.)
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User Manual
PRE-SUPPORT EVALUATION
Before initiating the procedure, evaluate the patient for factors that
may prevent successful placement of the Impella Catheter. Use imaging
technology to examine the patient’s vasculature access site. An echo
assessment of the left ventricle is also recommended to rule out left
ventricular thrombus, mechanical aortic valves, or severe aortic insufficiency.
Consider inserting a diagnostic Pulmonary Artery (PA) catheter to provide
continuous hemodynamic monitoring, including pulmonary artery and central
venous pressures, measurement of cardiac output, and SvO2.
STARTUP
SUPPLIES NEEDED
• Automated Impella Controller
• Impella 5.5®with SmartAssist®Catheter and accessories
• Diagnostic catheter (AL1 or MP without side holes or pigtail without
side holes)
• 500 cc bag of glucose solution for purge solution in water
(5% recommended; 5% to 20% acceptable) with 25 or 50 IU heparin/mL
• 10 mm x 20 cm Hemashield Platinum vascular graft (if using Axillary
Insertion kit)
• Impella Axillary Insertion kit for axillary insertion of the Impella
Note: If the purge solution is supplied in bottles, open the vent on the purge
fluid spike and follow the same procedure as if supplied in bags.
CASE START
If you miss a step in the process of setting up the Impella Catheter, or if
you exceed the amount of time allowed to complete a step, the Automated
Impella Controller will display additional instruction screens for continuing the
setup process for some steps. For the steps discussed below, all shaded steps
require sterile technique.
1. Press the START NEW CASE soft button from the startup screen or
plug in a new Impella Catheter. “Case Start” can also be selected by
pressing the MENU soft key.
2. The controller displays the screen shown below.
INSERT PURGE CASSETTE
1. Open the purge cassette package.
2. Secure the yellow luer connector on the purge tubing to the sterile field.
3. Pass the purge cassette and spike off the sterile field.
4. Spike the glucose bag/bottle.
5. Press the NEXT soft button to continue.
6. Open the purge cassette door by pressing the release on the left side
of the controller. Insert the purge cassette into the Automated Impella
Controller.
7. Insert the purge cassette into the compartment on the front of the
controller. Follow the diagram on the inside of the purge cassette door
for proper placement.
8. Slide the purge disc into the slot to the right of the purge cassette
until it snaps into place. The controller will automatically begin
priming the purge cassette.
9. Extend the purge tubing and close the purge cassette door. There is
sufficient room around the edges of the purge cassette door so that it
will not pinch the purge tubing as it exits.
10. The controller automatically begins priming the purge cassette after it
is inserted. The progress bar marks the progress of the purge cassette
priming.
CONNECT THE IMPELLA CATHETER
1. Remove the Impella Catheter from its package using sterile technique
and inspect the catheter for damage.
2. Inspect the cable for damage, including damage to the connector pins at
the controller end.
3. Pass the sterile connector cable from the Impella Catheter off the sterile
field.
4. Open the cover on the blue catheter plug by rotating clockwise. Line
up the notch on the connector cable with the notch in the blue
catheter plug on the front of the Automated Impella Controller and
plug the cable into the controller.
5. Once the purge cassette is primed and the controller detects that the
connector cable is plugged in, it prompts you to connect the luer to
the Impella Catheter.
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Impella 5.5®with SmartAssist®Circulatory Support System
6. Connect and tighten the yellow luer on the purge tubing to the Impella
Catheter sidearm if not already complete.
7. When the controller detects that the luer is connected, it
automatically begins priming the purge lumen.
8. Snap the purge clip (located on the pressure reservoir of the clear
sidearm) to the connector cable
9. Once the purge lumen is primed, the controller automatically advances to
the next screen.
10. The first step on the next screen prompts you to enter the purge
fluid information.
ENTER PURGE FLUID DATA
1. Enter the purge fluid information.
2. To select the default values displayed on the screen, press the
ACCEPT soft button. This will select those values and automatically
advance to the next screen. Note: The default purge fluid values will
be the purge fluid values from the last Case Start performed on a
given Automated Impella Controller.
3. To change the purge fluid information, press the EDIT soft buttons,
scroll to the appropriate item and push the selector knob to select it
or use the white arrow soft buttons. Then scroll through the values
and push the selector knob or press SELECT to make a new selection.
Press the DONE button to finish editing. The controller will use the
default values if no other selections are made.
• Purge fluid can be set to 50 mL, 100 mL, 250 mL, 500 mL, or
1000 mL.
• Glucose (Dextrose) concentration can be set to 5%, 10% or 20%.
• Heparin concentration can be set to 0 IU/ml, 5 IU/ml, 6.25 IU/ml,
10 IU/ml, 12.5 IU/ml, 20 IU/ml, 25 IU/ml, 40 IU/ml, 50 IU/ml.
SECURE THE PURGE TUBING
1. To complete the setup, connect the purge tubing to the white
connector cable by pushing the purge tubing into the clips attached to
the white connector cable.
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User Manual
AXILLARY INSERTION OF THE IMPELLA
5.5®CATHETER
NOTE – Proper surgical procedures and techniques are the
responsibility of the medical professional. The described
procedure is furnished for information purposes only. Each
physician must evaluate the appropriateness of the procedure
based on his or her medical training and experience, the type of
procedure, and the type of systems used.
If the Impella Catheter is used in the OR as part of open heart surgery,
manipulation may be performed only at the access site. Direct manipulation
of the catheter assembly through the aorta or ventricle may result in serious
damage to the Impella Catheter and serious injury to the patient.
When using a pigtail diagnostic catheter with side holes, ensure that the
guidewire exits the end of the catheter and not the side hole. To do so,
magnify the area one to two times as the guidewire begins to exit the pigtail.
During placement of the Impella Catheter, take care to avoid damage to the
inlet area while holding the catheter and loading the placement guidewire.
The introducer and graft lock are supplied sterile and can be used only if
the packaging is not damaged and the expiration date has not elapsed.
Fluoroscopy is required for the insertion of the Impella guidewire and
Impella Catheter.
During insertion, avoid manual compression of the inlet or outlet areas of
the Impella Catheter or the sensor area of the cannula on the Impella 5.5
with SmartAssist Catheter.
The graft must be affixed to the introducer proximal to the retainers on the
introducer repositioning unit to prevent the introducer from sliding out of the
graft.
When inserting the Impella Catheter through the introducer and into
the graft, be sure to clamp the graft with a vascular clamp just above
the anastomosis to avoid blood loss through the pump cannula during
insertion through the valve.
The Impella Axillary Insertion kit is intended to be used for insertion only.
To provide continued hemostasis, the introducer must be peeled away and
the repositioning unit inserted into the graft.
Do NOT resterilize or reuse any components of the Impella Axillary
Insertion kit. All components are disposable and intended for single use
only. Reuse, reprocessing, or resterilization may compromise performance.
The introducer is designed to be inserted into a graft. It is not intended for
direct insertion into the artery.
Abiomed recommends the use of a 10 mm diameter Hemashield Platinum
graft with the introducer for proper fit and hemostasis between the graft
and the introducer. A smaller diameter graft may not fit over the introducer.
Abiomed recommends the use of a 20 cm length graft to allow enough
length to fully insert the Impella Catheter cannula into the graft prior
to releasing vascular clamps at the anastomosis to minimize blood loss
through the cannula.
Do NOT kink or clamp the white portion of the Impella Catheter with cm
markings with anything other than a soft jaw vascular clamp.
Do NOT kink or clamp the peel-away introducer.
Proper positioning of the Impella Catheter is extremely important and it is
worthwhile to take extra time when positioning the catheter.
Take care to insert the guidewire with diagnostic catheter into the middle
of the hemostatic valve of the introducer to avoid tearing the valve.
When inserting the Impella Catheter into the introducer, take care to
insert it straight into the center of the introducer valve.
Be sure that the stopcock on the peel-away introducer is always kept in the
closed position. Significant bleed back can result if the stopcock is open.
The following steps describe the recommended technique for axillary artery
insertion of the Impella 5.5®with SmartAssist®Catheter.
1. Isolate and expose the axillary artery and obtain control via proximal and
distal vessel loops.
2. Attach a 10 mm diameter x 20 cm long vascular graft to the axillary
artery using a standard end-to-side anastomosis. NOTE: Abiomed
recommends using a Hemashield Platinum graft and recommends using
at least a 60 degree bevel on the end of the graft to facilitate passage of
the rigid motor housing into the artery.
3. Clamp the graft with a vascular clamp just above the anastomosis and
loosen the vessel loops to allow blood to flow into the graft to assess for
hemostasis at the anastomosis.
4. Insert the introducer into the graft and secure it with one (1) provided
graft lock. To place the graft lock, open it and place it between the
retainers and the hub on the introducer to prevent the introducer from
sliding out of the graft. NOTE: If a graft other than the Hemashield
Platinum is used, two graft locks may be required to maintain hemostasis
between the graft and the introducer. Correct positioning of the second
graft lock is illustrated in below.
Introducer, Graft Lock, and Hemashield Platinum Graft (Graft Not Supplied)
Correct Positioning If Second Graft Lock Required
5. Secure the graft lock by pressing both the outside tabs together. When
fully closed, the graft lock provides hemostasis. If hemostasis
is not achieved, make sure to press the two tabs together to fully close
the graft lock as shown below. The graft lock cannot be damaged by
over closing. NOTE: The graft may also be secured over the introducer
using heavy sutures or umbilical tape.
Closing the Graft Lock
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Impella 5.5®with SmartAssist®Circulatory Support System
6. Remove the vascular clamp on the graft and insert a 0.035 inch
diagnostic guidewire with a 4–6 Fr diagnostic catheter into the
introducer, taking care to center the wire and catheter in the center of
the hemostatic valve. Advance the guidewire and catheter into the left
ventricle.
7. Remove the diagnostic guidewire and exchange it for a stiff 0.018 inch
placement guidewire. With the 0.018 inch placement guidewire properly
positioned in the left ventricle, remove the diagnostic catheter.
8. Administer heparin per institutional protocol. When the ACT is greater
than or equal to 250 seconds, remove the dilator.
9. Remove the protective sleeve on the provided 8 Fr silicone-coated
lubrication dilator, being careful to avoid getting silicone on your hands.
Insert the dilator into the introducer over the 0.018 inch placement
guidewire to coat the hemostatic valve with silicone oil to facilitate
insertion of the Impella Catheter through the hemostatic valve assembly.
Once fully inserted, remove the dilator, keeping the 0.018 inch placement
guidewire in place.
10. Clamp the graft with a vascular clamp just above the anastomosis to
avoid blood loss through the pump cannula during insertion through the
valve.
11. While maintaining guidewire position, backload the Impella Catheter
onto the 0.018 inch placement guidewire and advance the catheter over
the guidewire through the introducer into the graft such that the entire
pump cannula and motor housing resides in the graft and only the
catheter shaft is seen exiting the valve.
12. Remove the vascular clamp and continue inserting the Impella Catheter
into the aorta. Continue advancing across the aortic valve using
fluoroscopic imaging to properly position the cannula bend at the aortic
valve annulus, placing inlet approximately 5 cm deep into ventricle.
Remove the placement guidewire and initiate Impella Catheter support
as described later in this section.
13. Clamp the graft adjacent to the axillary artery with a soft jawed vascular
clamp or have an assistant apply digital pressure to control bleeding at
the base of the graft so that the introducer can be removed and the graft
shortened. NOTE: To ensure the soft jaw vascular clamp is completely
sealing over the graft and the 9Fr catheter, open the sidearm flush valve
on the introducer and verify blood is not leaking from the system.
14. Slide the repositioning sheath back to the red Impella plug.
NOTE: For the 23F x 6cm peel-away introducer, it may be necessary to
pull the introducer over the repositioning sheath to remove the peel-away
completely from the artery
15. To remove the introducer, release the graft lock by pressing the two
adjacent long tabs together as shown below and remove it from the
graft.
Releasing the Graft Lock
16. Slide the introducer fully out of the graft prior to peeling it away. To peel
the introducer off the catheter shaft, crack the hub by applying pressure
to the thumb tabs and then peel the sheath off the catheter. NOTE:
When breaking the hemostatic valve in the sheath hub, the valve may
stretch before separating.
a). Grasp the two “wings” and bend back until the valve assembly
comes apart. Continue to peel the two wings until the introducer is
completely separated from the catheter shaft.
17. Trim any excess graft and slide the blue suture hub into the graft. NOTE:
The hub should be at the skin level and the length of the remaining graft
material should be just long enough to secure the graft around the blue
suture hub with all of the graft buried beneath the skin.
18. Using heavy silk suture, secure the graft around the blue suture hub so
that the position of the Impella Catheter can still be adjusted. Remove
the vascular clamp adjacent to the axillary artery.
19. The wound should be closed over the trimmed graft with the end of the
blue suture hub clearly visible. Anchor the hub securely to the skin.
20. If there is slack in the catheter, remove the excess slack. Verify placement
with fluoroscopy and with the placement signal. If the Impella 5.5
Catheter advances too far into the left ventricle and the controller
displays a ventricular waveform rather than an aortic waveform, follow
steps a-c below.
a) Pull the catheter back until an aortic waveform is present on the
placement screen.
b) When the aortic waveform is present, pull the catheter back an
additional 3cm for Impella 5.5 with SmartAssist. (The distance
between adjacent markings on the catheter is 1 cm.)
c) The catheter should now be positioned correctly.
21. Attach the anticontamination sleeve to the blue suture hub. Lock the
anchoring ring in place by turning it clockwise. Secure the catheter
shaft in place by tightening the Tuohy-Borst. Extend the sterile sleeve to
maximum length and secure the end closest to the red Impella®plug by
tightening the anchoring ring.
ALTERNATE INSERTION TECHNIQUE USING A SIDEARM
GRAFT & SILICONE PLUGS
1. After exposing the axillary artery and making the incision as described in
the steps above, prepare a Dacron®vascular graft (10 mm x 20 cm) by
beveling the end of the graft at a 45 to 60 degree angle.
2. Tighten the distal and proximal vessel loops to control bleeding.
3. Attach the vascular graft using the standard end-to-side anastomosis
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User Manual
4. Assess the anastomosis for hemostasis.
5. Attach a standard 6 Fr introducer to the distal end of the graft.
6. Advance a diagnostic catheter (Abiomed recommends a 6 Fr AL1 or
Multipurpose without side holes or 4–5 Fr pigtail with or without side
holes) over a diagnostic 0.035 inch or 0.038 inch guidewire into the left
ventricle.
7. Remove the diagnostic guidewire and exchange it for the supplied 0.018
inch placement guidewire.
8. Tighten the vessel loops to control bleeding and remove the 6 Fr
introducer.
9. Moisten the Impella 5.5 Catheter and push one of the silicone plugs onto
the catheter shaft adjacent to the Impella 5.5 Catheter motor.
10. Backload the Impella 5.5 Catheter onto the 0.018 inch guidewire (as
described in the steps in previous step 11).
11. With the graft held at the base, place the Impella 5.5 Catheter into the
open end of the graft up to the level of the silicone plug.
12. Secure umbilical tape around the silicone plug.
13. Loosen both vessel loops and advance the Impella 5.5 Catheter along
the guidewire into the left ventricle until it is properly positioned.
To prevent device failure, do not start the Impella 5.5 Catheter until the
placement guidewire has been removed.
Do NOT remove the Impella 5.5 Catheter over the length of the
placement guidewire.
14. Remove the guidewire.
15. Place a soft-jawed clamp at the anastomosis and remove the silicone
plug.
16. Trim any excess graft and slide the repositioning sheath into position.
17. Using a heavy silk tie or umbilical tape, secure the graft around the blue
hub of the repositioning sheath.
18. Close the wound over the trimmed graft with the end of the blue suture
hub clearly visible. The steering catheter for the Impella 5.5 can be
manipulated if needed by unsecuring the repositioning unit and moving
the catheter in or out.
19. If there is slack in the catheter, remove the excess slack. Verify placement
with fluoroscopy and with the placement signal. If the Impella 5.5
Catheter advances too far into the left ventricle and the controller
displays a ventricular waveform rather than an aortic waveform, follow
steps a-c below.
a) Pull the catheter back until an aortic waveform is present on the
placement screen.
b) When the aortic waveform is present, pull the catheter back an
additional 3cm for Impella 5.5 with SmartAssist. (The distance
between adjacent markings on the catheter is 1 cm.)
c) The catheter should now be positioned correctly.
20. Attach the anticontamination sleeve to the blue suture hub. Lock the
anchoring ring in place by turning it clockwise. Secure the catheter
shaft in place by tightening the Tuohy-Borst. Extend the sterile sleeve to
maximum length and secure the end closest to the red Impella®plug by
tightening the anchoring ring.
DIRECT AORTIC INSERTION
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.
Avoid manual compression of the inlet, outlet, or sensor areas of the
cannula assembly.
Do NOT kink or clamp the Impella Catheter with anything other than a soft
jaw vascular clamp. Do NOT kink or clamp the peel-away introducer.
Handle with care. The Impella 5.5 Catheter can be damaged during
removal from packaging, preparation, insertion, and removal. Do NOT
bend, pull, or place excess pressure on the catheter or mechanical
components at any time.
An incision larger than 6 mm may allow the front plug to advance into
the aorta.
The Impella 5.5 Catheter is surgically inserted when there is access to the
ascending aorta through a sternotomy or thoracotomy. Transesophageal
echocardiography (TEE) is required to guide placement.
INSERTION PREPARATION
When using a pigtail diagnostic catheter with side holes, ensure that the
guidewire exits the end of the catheter and not the side hole. To do so,
magnify the area one to two times as the guidewire begins to exit the pigtail.
1. Using the supplied sterile incision template for positioning, place a
sidebiter clamp on the aorta at least 7 cm above the valve plane. An
incision too close to the aortic valve annulus could result in the catheter
outlet area in the graft rather than the aorta.
2. Make an incision (or punch) no larger than 6 mm at the insertion site on
the ascending aorta. The incision must be ≤ 6 mm in length to prevent
the front silicone plug from advancing into the aorta through the incision.
3. Attach the Dacron®vascular graft (10 mm x 15 cm) to the aorta using the
standard end-to-side anastomosis.
4. Administer heparin and achieve ACT of at least 250 seconds. Note:
Maintaining ACT at or above 250 seconds will help prevent a thrombus
from entering the catheter and causing a sudden stop on startup.
*If the patient is receiving a GP IIb-IIIa inhibitor, the Impella 5.5 Catheter
can be inserted when ACT is 200 or above.
5. When the anastomosis is complete, place a clamp at the distal end of the
graft and then release the proximal clamp at the base of the graft. Examine
the suture line for leaks and reclamp the graft at the base.
6. Moisten the Impella 5.5 Catheter and push both silicone plugs up against
the motor housing as shown below.
Impella 5.5 Catheter with Silicone Plugs
7. With the graft clamped at the base, place the Impella 5.5 Catheter into
the open end of the graft up to the level of the rear plug.
8. When the catheter is in position, secure a tourniquet around the rear
silicone plug. Tighten the tourniquet sufficiently to control bleeding
around the rear plug while still allowing the catheter to slide through the
plug.
8

9
Impella 5.5®with SmartAssist®Circulatory Support System
9. Release the clamp and advance the Impella 5.5 Catheter into the aorta.
10. If the patient is on cardiopulmonary bypass (CPB), allow the heart to fill
by restricting the return flow to the bypass machine and reducing CPB
flow to a minimum setting, as long as acceptable physiologic systemic
flow is maintained.
11. As soon as the motor housing has passed into the aorta, use a ligature to
loosely secure the front silicone plug flush to the graft. The silicone plug
should be in the most proximal portion of the graft. Note: There should
be no movement of the front silicone plug within the graft; however, the
catheter shaft should move without resistance within the plug. When
securing the front silicone plug to the graft, do not penetrate the silicone
plug too deeply as this could cause damage to the Impella 5.5 Catheter.
12. While the catheter is being advanced in the aorta, the initial placement
signal has the characteristics of an aortic placement signal. Do not allow
the front plug to advance beyond the base of
the graft.
13. To aid in passing the catheter through the aortic valve, apply slight
pressure to the posterior aspect of the aortic valve to produce temporary
aortic insufficiency.
14. Gently advance the catheter forward until the inlet crosses the aortic
valve and the bend of the catheter is at the level of the aortic valve
annulus. Confirm with TEE guidance.
POSITIONING AND STARTING THE
IMPELLA 5.5®WITH SMARTASSIST®
CATHETER
When the Impella 5.5 with SmartAssist Catheter is not correctly placed, there
is no effective unloading of the ventricle (hydraulic short circuit). The patient
may not be benefiting from the flow rate shown on the controller.
1. Reconfirm that the placement guidewire has been removed and
Confirm that the controller displays a pulsatile waveform and the
cannula bend at the aortic valve annulus, placing inlet approximately
5 cm deep into ventricle. (See step 6 if the controller displays a
ventricular waveform.)
2. Press START IMPELLA soft button to open the P-level menu. Turn
the selector knob to increase the P-level from P-0 to P-2.
3. Press the selector knob to select the new P-level. Increase the P-level
to P-9 to confirm correct and stable placement.
Retrograde flow will occur across the aortic valve if the flow rate of
the Impella Catheter is less than 0.5 L/min.
4. Evaluate the catheter position in the aortic arch. If there is slack in
the catheter, loosen the Touhy-Borst, remove the excess slack, and
RE-TIGHTEN THE TUOHY-BORST. The catheter should align against the
lesser curvature of the aorta rather than the greater curvature. Verify
placement with fluoroscopy and with the placement signal screen.
5. Reposition the catheter as necessary.
6. If the Impella Catheter advances too far into the left ventricle and the
controller displays a ventricular waveform (shown above) rather than an
aortic waveform, follow these steps to reposition the catheter.
a) Loosen the Touhy-Borst, pull the catheter back until an aortic
waveform is present on the placement screen.
b) When the aortic waveform is present, pull the catheter back an
additional 3 cm for Impella 5.5 with SmartAssist. (The distance
between adjacent markings on the catheter is 1 cm.)
c) RE-TIGHTEN THE TUOHY BORST
d) The catheter should now be positioned correctly.
USE OF THE REPOSITIONING UNIT
1. Slide the blue suture hub and advance the ribs into the graft.
2. Secure the repositioning unit to the patient with the blue suture pads or
a StatLock®stabilization device.
3. Evaluate the catheter position in the aortic arch. If there is excess slack,
loosen the Touhy-Borst, remove the excess slack, and RE-TIGHTEN THE
TUOHY-BORST. The catheter should align against the lesser curvature
of the aorta rather than the greater curvature. Verify placement with
fluoroscopy and with the placement signal.
4. Attach the anticontamination sleeve to the blue section of the
repositioning unit. Lock the anchoring ring in place by turning it
clockwise. Secure the catheter shaft in place by tightening the connected
anchoring ring.
5. Carefully extend the anticontamination sleeve to maximum length
and secure the end closest to the red Impella plug by tightening the
anchoring ring.
6. Select the lowest P-level that will enable you to achieve the highest
flow rate necessary for patient support. You can select one of ten
P-levels (P-0 to P-9) for the Impella 5.5 Catheter.
P-LEVEL
In P-LEVEL mode you can select one of ten P-levels (P-0 to P-9) for the
Impella 5.5 with SmartAssist Catheter (see table below). Select the lowest
P-level (P-2 or higher) that will enable you to achieve the highest flow rate
necessary for patient support.
P-level Mean Flow (L/min)
30 - 60 mmHg
Revolutions Per
Minute (rpm)
P-0 0 0
P-1 012,000
P-2 0.0 - 1.9 17,000
P-3 1.1 - 2.7 20,000
P-4 1.9 - 3.3 22,000
P-5 2.8 - 3.7 24,000
P-6 3.4 - 4.1 26,000
P-7 3.9 - 4.5 28,000
P-8 4.3 - 4.9 30,000
P-9 5.0 - 5.5 33,000
*Flow rate can vary due to suction or incorrect positioning
ENGLISH

User Manual
To operate the Impella Catheter in P-level mode:
1. Press the FLOW CONTROL soft button to open the FLOW
CONTROL menu.
2. Turn the selector knob to increase or decrease the flow rate.
3. Press the selector knob to select the new flow rate.
ADJUSTING THE LV PLACEMENT SIGNAL
The LV placement signal and LV estimates are not displayed when pumps
are running at P-3 or lower. Increase pump speed to P-4 or higher to
re-enable signal
Alarm conditions and low pump speeds may affect the LV placement
signal and estimates
Disruption of the outlet pressure placement signal, including alarms
related to the Ao placement signal, will prevent calculation and display of
an LV estimate. An operational Ao placement signal is required for the LV
estimate
LV placement signal calibration is not available if the P-level is less than P-4
or if Suction, Placement Signal Not Reliable, or positioning alarms are active
Abnormal conditions, including cardiac arrhythmia, Ao-LV uncoupling, or
aortic stenosis may limit the utility of the LV adjustment tool
ADJUST LV PLACEMENT SIGNAL
Adjust the LV placement signal to reduce potential measurement
variability. Adjust the LV Placement Signal when the white
notification appears on the screen. The notification appears first when
a suggested adjustment is calculated. If a suggested adjustment is calculated,
then a second notification will appear after 24 hours of pump use.
To adjust LV Placement Signal:
1. Press the MENU soft buttons.
2. Select “Adjust LV Signal” option with rotary knob
3. Adjust the waveform using toggle arrows or rotary knob. The LV
Adjustment defaults to the suggested adjustment value.
4. Press DONE to confirm suggested adjustment.
LV waveform adjustments occur in increments of 1 mmHg from -60 to
60 mmHg.
Recommended: Do not adjust to a value other than the suggested value.
Note: It is not atypical to see a LV systolic value higher than the Ao systolic
ENTERING CARDIAC OUTPUT
The cardiac output and cardiac power output metrics are for informational
purposes only. Do not use for diagnostic purposes or patient monitoring.
Independently verify all parameters displayed with a cleared or approved
diagnostic device. Enter cardiac output into the Automated Impella Controller
from a reference device, such as a Swan-Ganz catheter. Enter a new cardiac
output every 8 hours. After 7 hours from entry, a white notification will
trigger to enter a new cardiac output.
TO ENTER CARDIAC OUTPUT
1. Press the MENU soft button.
2. Select the “Enter Cardiac Output” using the rotary knob.
3. Enter the total Cardiac Output, which can be any value from 0.0 to
10.0 L/min in increments of 0.1 L/min
4. Press the DONE soft button or the rotary knob to complete.
10

11
Impella 5.5®with SmartAssist®Circulatory Support System
A Cardiac Output Confirmation will be displayed if a total Cardiac Output is
entered that is less than or equal to the current Impella Flow. The CONFIRM
soft button will use the current Impella Flow as the total Cardiac Output entry
and the Native Cardiac Output will not be trended. The BACK soft button
will go back to the Enter Cardiac Output screen. The CANCEL soft button
will exit the workflow.
CARDIAC OUTPUT, NATIVE CARDIAC OUTPUT & CARDIAC
POWER OUTPUT CALCULATIONS
Once a cardiac output is entered, the Automated Impella Controller can
calculate an initial cardiac power output and native cardiac output using the
following equations:
CPO = (CO x MAP) / 451
NCO = CO - Impella Flow
The Native Cardiac Output estimate is derived from a relationship between
native function and aortic pulse pressure (PP). This relationship is linear and
scaled by a calibration factor, ß which may vary between patients and as an
individual patient’s condition changes. This relationships can be shown by the
following equation:
NCO= ß x PP
Once the calibration factor is obtained, the Automated Impella Controller will
continue to calculate the cardiac output, native cardiac output, and cardiac
power output for the next 8 hours using the above equations.
If cardiac power output values are below or equal to 0.6, the value will
display as yellow.
Note: Do not use values as a clinical diagnostic tool, this is for informational
purposes only.
CARDIAC OUTPUT ENTRY REMINDERS
A white reminder to enter the CO will appear every 15 minutes for the last
hour prior to the 8 hour timeout. If a new CO is not entered after 8 hours, the
values will show as dash marks until a new cardiac output is entered.
A white reminder will also be displayed to update the CO if the Automated
Impella Controller detects a significant change in the vascular state. This
notification will be triggered if the average NCO or PP diverges from their
initial values by a significant amount.
PURGE CASSETTE PROCEDURES
When replacing the purge cassette or purge fluid, the replacement
process should be completed within 90 seconds of disconnecting
the luer. The Impella Catheter may be damaged if replacement
takes longer than 90 seconds of disconnecting the luer.
There are three procedures for maintaining the Impella Catheter purge
system:
• Change cassette and purge fluid bag
• Change purge fluid bag
• De-Air purge system
Each procedure can be accessed using the PURGE MENU soft button. The
purge cassette procedures are discussed below.
CHANGE CASSETTE AND BAG
The Purge Cassette may need to be replaced for extended use of the Impella
system.
Follow these steps to change both the purge cassette and purge fluid:
1. Press PURGE MENU and select “Change Cassette and Bag” from the
menu.
2. Select START to begin the cassette and fluid change process.
3. When prompted by the controller, disconnect the luer from the Impella
catheter.
Note on Connecting Purge Tubing to the Catheter:
If included, remove and discard the Y-connector and connect the
yellow luer on the purge tubing directly to the yellow check valve on
the Impella Catheter.
4. Open the purge cassette door by pressing the button on the left side
of the console. Remove and discard the old cassette and purge fluid
bag.
5. Open the new purge cassette. Spike the new purge fluid bag with the
new purge cassette tubing. Select NEXT to continue.
6. Insert the new purge cassette into the controller. Be sure to slide the
purge disc into place and extend the purge tubing through the gap in
the purge cassette door when you close the door.
7. Confirm the luer is disconnected. Press NEXT to proceed to prime the
purge cassette.
ENGLISH

User Manual
8. Update the purge fluid information.
a) To select the default purge fluid values displayed on the
screen, select CONFIRM.
b) To change the purge fluid information, select EDIT. Then use
the soft keys to navigate selections and edit values. Select
DONE to complete editing.
9. When Steps 1 through 8 are complete, connect the luer from the new
purge cassette to the Impella catheter.
CHANGE PURGE FLUID BAG
Note on Purge Solution Bottles:
If the purge solution is supplied in bottles, open the vent on the purge
fluid spike and follow the same procedure as if supplied in bags.
These are the steps you will follow to change only the purge fluid:
1. Press PURGE MENU and select “Change Purge Fluid Bag.”
2. Select START to begin the purge fluid change process.
3. When prompted by the controller, remove the old purge bag and
replace by spiking the new purge fluid bag. Select NEXT to advance
to the next step.
4. Update the purge fluid information.
a) To select the default purge fluid values displayed on the
screen, select CONFIRM.
b) To change the purge fluid information, select EDIT. Then use
the soft keys to navigate selections and edit values. Select
DONE to complete editing.
5. When prompted by the controller, disconnect the luer from the Impella
Catheter. The controller will automatically prime the tubing, which
will flush the fluid from the last bag out of the purge cassette tubing.
Note: the instructions to disconnect the luer and to automatically
prime the tubing only occurs if the user changed the purge fluid
concentration
a) To skip the flush select SKIP PRIME.
6. When prompted by the controller, connect the yellow luer from the
purge cassette to the Impella catheter.
DE-AIR PURGE SYSTEM
These are the steps you will follow to de-air the purge system:
1. Press PURGE MENU and select “De-Air Purge System.”
2. Select START to begin the de-air process.
3. Make sure that the purge fluid bag is NOT empty or inverted and that
the tubing is NOT kinked. Select NEXT to continue.
4. Disconnect the purge tubing from the Impella Catheter.
5. Confirm that no air remains in the purge tubing. If air remains, press
BACK to repeat the air removal process.
6. Connect the purge tubing to the luer on the Impella Catheter to
complete the de-air procedure.
AIR DETECTED ALERT
During any of the purge system processes above, the controller automatically
monitors for air in the system. If air is detected in the system, the controller
provides an alert to disconnect the luer, as shown below. Once the luer is
disconnected, the controller automatically de-airs the purge system.
PATIENT WEANING
Weaning the patient from the Impella Catheter is at the discretion of the
physician. The Impella 5.5®with SmartAssist®has been approved for ≤ 30
days of use. However, weaning could be delayed beyond the normal use for
temporary support as an unintended consequence of continued instability of
the patient’s hemodynamics. Inability to wean the patient from the device
within a reasonable time frame should result in consideration of a more
durable form of left ventricular support. The LVEDP/CO Trend can be used
while weaning. Refer to the Automated Impella Controller Instructions for Use
document for more information.
The following weaning instructions are provided as guidance only.
RAPID WEANING
1. Initiate rapid weaning by decreasing catheter P-level in 2-level steps at
intervals of several minutes (for example, P-6 to P-4 to P-2). Do NOT
decrease P-level to below P-2 until just before removing the catheter
from the ventricle.
2. When the P-level has been reduced to P-2, maintain the patient on
P-2 support for at least 10 minutes before discontinuing circulatory
support.
3. If the patient’s hemodynamics remain stable, decrease the P-level to
P-1, pull the catheter into the aorta, and stop the motor by decreasing
the P-level to P-0.
4. Explant the catheter.
5. Follow institutional guidelines for arterial closure.
6. Disconnect the connector cable from the Automated Impella Controller
and turn the controller off by pressing the power switch on the side of
the controller for 3 seconds.
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Impella 5.5®with SmartAssist®Circulatory Support System
OPERATING THE IMPELLA 5.5 WITH
SMARTASSIST CATHETER WITHOUT
HEPARIN IN THE PURGE SOLUTION
The Impella 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 to assess the risks versus
benefits of operating the Impella System without heparin.
If it is in the best interest of the patient to operate the system without
heparin, the dextrose solution is still required, and physicians should consider
systemic delivery of an alternative anticoagulant. The Impella Catheter has
not been tested with any alternative anticoagulants in the purge solution.
Use of alternative anticoagulants may reduce the longevity or performance
of the Impella catheter.
OPERATING THE IMPELLA 5.5
WITH SMARTASSIST CATHETER IN
ELECTROMAGNETIC FIELDS
The Impella Catheter contains a permanent magnet motor that emits an
electromagnetic field. This field may produce electromagnetic interference
with other equipment. In addition, other equipment that emits a strong
electromagnetic field may affect the operation of the Impella Catheter motor.
ELECTROANATOMIC MAPPING (EAM) SYSTEMS
The electromagnetic field emitted by the Impella Catheter may produce
interference with the magnetic location detection component of the
electroanatomic mapping (EAM) system, particularly when the mapping
catheter is close to the Impella Catheter motor. For example, mapping in the
right or left ventricular outflow tracts places the mapping catheter in close
proximity to the Impella Catheter motor in the ascending aorta.
Electromagnetic interference may appear as:
• Instability in the displayed location of the mapping catheter
• Magnetic interference errors generated by the electroanatomic
mapping system
When operating the Impella®Catheter in the presence of an EAM system,
use P-level mode. Operate the Impella Catheter at P-1–P-5 or P-7. The motor
speeds at these P-levels cause the least interference. Best performance is
observed when the Impella Catheter motor is at least 3 cm from the sensors
in the mapping catheter. If you suspect interference, follow the
troubleshooting steps below.
Observation Actions
Interference with
the magnetic
location detection
component of the
EAM system
1. Check for and address other sources of interference.
2. Reposition the Impella Catheter to ensure that the
Impella motor is at least 3 cm from the sensors in
the mapping catheter; however do NOT pull the inlet
area out of the left ventricle.
3. Ensure that the Impella Catheter is operating at
P-1–P-5 or P-7, as these P-levels cause the least
interference.
SLOW WEANING
1. Initiate slow weaning by decreasing catheter P-level in 2-level steps
over time as cardiac function allows (for example, P-6 to P-4 to P-2).
Do NOT decrease P-level to below P-2 until just before removing the
catheter from the ventricle.
2. When the P-level has been reduced to P-2, maintain the patient on
P-2 support until the patient’s hemodynamics remain stable before
discontinuing circulatory support.
3. If the patient’s hemodynamics remain stable, decrease the P-level to
P-1, pull the catheter into the aorta, and stop the motor by decreasing
the P-level to P-0.
4. Explant the catheter.
5. Follow institutional guidelines for arterial closure.
6. Disconnect the connector cable from the Automated Impella
Controller and turn the controller off by pressing the power switch on
the side of the controller for 3 seconds.
REMOVING THE IMPELLA 5.5®WITH
SMARTASSIST®CATHETER
The Impella Catheter can be removed after weaning when the introducer is
still in place or when the catheter is secured with the repositioning sheath.
REMOVING THE IMPELLA CATHETER WITH THE
INTRODUCER IN PLACE
1. Reduce the P-level to P-0.
2. Remove the Impella Catheter through the introducer.
3. Wait until ACT drops below 150 seconds.
4. When ACT is below 150 seconds, remove the introducer.
5. Disconnect the connector cable from the Automated Impella
Controller and turn the controller off by pressing the power switch on
the side of the controller for 3 seconds.
6. Apply manual compression for 40 minutes or per hospital protocol.
REMOVING THE IMPELLA CATHETER SECURED WITH THE
REPOSITIONING UNIT
1. When ACT is below 150 seconds, press FLOW CONTROL and reduce
the P-level to P-0.
2. Remove the Impella Catheter and repositioning unit together (the
catheter will not come through the repositioning unit).
3. Disconnect the connector cable from the Automated Impella
Controller and turn the controller off by pressing the power switch on
the side of the controller for 3 seconds.
4. Apply manual compression for 40 minutes or per hospital protocol.
VASCULAR GRAFT CLOSURE
When closing the vascular graft, consider individual patient characteristics
and select the strategy most consistent with an optimal clinical result. The
entire vascular graft can be removed if indicated, but it is not mandatory to
do so. Graft closure options include:
• Amputating the vascular graft and sewing the small end-to-side
remnant closed by hand
• Using a vascular stapler to close the graft near the surface of the
aorta
• Removing the complete graft with local patch closure, if necessary
ENGLISH

User Manual
MAGNETIC NAVIGATION SYSTEMS (MNS)
When initiating Impella Catheter support in the presence of a magnetic
navigation system (MNS), follow the steps below:
1. Insert the Impella Catheter following the steps outlined in this manual.
2. Place the MNS magnets in the “Reduced” or “Stowed” position.
3. Start the Impella Catheter in the manner described in this manual.
Increase P-level to at least P-5.
4. Place the MNS magnets in the “Navigate” position and proceed with
magnetic navigation.
Keep operating the Impella Catheter at a P-level of at least P-5 when the
MNS magnets are in the “Navigate” position. If the P-level falls below P-5,
the Impella Catheter may stop running.
To resume operation, follow the steps below.
During magnetic navigation of the mapping catheter, the motor current of the
Impella Catheter may temporarily increase to the point that the catheter stops
running. The table below explains how to resume operation.
When the MNS magnets are in the “Navigate” position, the displayed Impella
Catheter flow may be artificially elevated. To accurately assess the flow rate,
note the displayed flow when the magnets are in the “Stowed” position.
Observation Actions
Unable to start
Impella
or
Impella stops
running
1. Place the MNS magnets in the “Reduced” position and
attempt to start the Impella Catheter.
2. If the Impella Catheter does NOT start with the magnets
in the “Reduced” position, place the magnets in the
“Stowed” position and start the Impella Catheter.
3. Increase the Impella Catheter P-level to P-5 or higher.
4. Place the MNS magnets in the “Navigate” position and
proceed with magnetic navigation.
MNS magnets:
“Navigate”
Displayed flow
seems too high
or
MNS magnets:
“Stowed”
Displayed flow
drops
The Impella Catheter displayed flow will be artificially
elevated when the MNS magnets are in the “Navigate”
position.
The displayed flow will be accurate when the MNS magnets
are in the “Stowed” position.
ALARMS OVERVIEW
The Automated Impella Controller monitors various functions to determine
whether specific operational parameters are within expected limits. When a
parameter goes outside of its specified limits, the controller sounds an alarm
tone and displays an alarm message that can be viewed on the display screen
on the front of the controller. The alarm tone indicates the severity of the
alarm. The alarm message on the display screen is color-coded for severity
and provides details on the cause of the alarm and how to resolve the alarm.
For a full list of all Impella alarms, refer to the Automated Impella Controller
Instructions for Use document.
ALARM LEVELS
Alarms are divided into three levels of severity:
• Advisory (white)
• Serious (yellow)
• Critical (red)
MUTE ALARM FUNCTION
Pressing the MUTE ALARM button on the upper right of the Automated
Impella Controller display screen will silence the audible alarm indicator for
2 minutes (for red or yellow alarms) or 5 minutes (for white advisory alarms).
When an alarm is silenced, the words “MUTE ALARM” next to the button are
replaced by the mute alarm indicator, a crossed-out bell icon.
The audible indicator will shut off if an alarm condition is resolved before
you press MUTE ALARM. The visual message, however, will continue to
be displayed, with the alarm header on a gray background, for 20 minutes
or until you press MUTE ALARM. This allows you to identify the alarm that
occurred.
Category Description Audible Indicator* Visual Indicator
Advisory Notification 1 beep every 5 minutes Alarm header on
white background
Serious
Abnormal
situation.
Prompt action
needed.
3 beeps every
15seconds
Alarm header on
yellow background
Critical
High priority.
Immediate
action needed.
10 beeps every
6.7seconds
Alarm header on red
background
* Sound pressure of audible alarm indicators is >80 dBA
14

15
Impella 5.5®with SmartAssist®Circulatory Support System
SYMBOLS
Caution; follow instructions for use
Defibrillator-proof type CF equipment
Keep dry
+10°C
+30°C
Storage temperature
(e.g. 10°C to 30°C)
Declares conformity with Directive
93/42/EEC for medical devices or with
Regulation (EU) 2017/745 on medical
devices, and with Directive 2011/65/EU
on the restriction of the use of certain
hazardous substances in electrical and
electronic equipment
2019-11-06 Date of manufacture (eg, 2019-11-06)
Protect from sunlight
Symbol for lot designation; the
manufacturer’s lot designation must be
stated after the LOT symbol
123456
Abiomed part number
(eg, part number 123456)
123456
Manufacturer’s serial number
(eg, serial number 123456)
2019-11-06 Use-by date
(eg, use before 2019-11-06)
Do not reuse
Sterilized using ethylene oxide
Medical Device
Do Not Flush Do NOT flush
Glucose Use glucose in the purge fluid
IMPELLA 5.5 CATHETER PARAMETERS
Speed range 0 to 33,000 rpm
Power consumption Less than 1.07 W
Voltage Max. 18 V DC
Flow-Maximum 5.5 L/min
Purging the Impella 5.5 Catheter
Recommended purge fluid
Glucose concentration
Purge pressure
Purge flow
5% glucose solution in water
with heparin concentration of
25 or 50 IU per mL
5% to 20%
300 to 1100 mmHg
2 to 28 mL/hr
Maximum duration of use
EU
Reliability
Up to 30 days
91.4% with 80% confidence at
30 days based on chi-squared
test
Dimensions of Impella 5.5 Catheter
Length of invasive portion (without catheter)
Diameter (Motor)
Diameter (Cannula)
114 mm
18 Fr (6.3mm)
21 Fr (7 mm)
Classification per DIN EN 60601-1 Protection class I, degree of
protection:
CF (Automated Impella
Controller and Impella 5.5
Catheter)
Classification per directive 93/42/EEC Class III
Latex free Yes
ENGLISH

User Manual
IMPELLA 5.5®WITH SMARTASSIST®CATHETER DIMENSIONS
DISPOSING OF THE IMPELLA 5.5 WITH SMARTASSIST CATHETER AND ACCESSORIES
(EUROPEAN UNION)
The Impella 5.5 with SmartAssist Catheter is disposable and must be disposed of in accordance with hospital regulations for blood
contaminated materials.
The Automated Impella Controller is marked according to Directive 2012/19/EU. Devices sold within the EU can be returned to Abiomed
Europe GmbH for correct disposal.
45.5 cm
Length of
sterile sleeve
70 cm
9 Fr
21 Fr
Outflow area
Inflow area
114 mm
96 mm
50 mm
16

17
Kreislaufunterstützungssystem Impella 5.5®mit SmartAssist®
ZIELGRUPPE
Diese Gebrauchsanweisung und das klinische Referenzhandbuch richten sich an medizinisches Fachpersonal. Es enthält klinische und technische Informationen
als Leitfaden für medizinisches Fachpersonal im Umgang mit dem Impella 5.5®mit SmartAssist®. Um das System verwenden zu können, müssen Sie diese
Anweisungen verstehen und befolgen. Das Impella 5.5 mit SmartAssist darf nur bestimmungsgemäß verwendet werden.
WARNHINWEISE
Warnhinweise zeigen Situationen an, die zu schweren oder tödlichen Verletzungen
führen können. Das dunkelgraue Symbol wird vor Warnhinweisen angezeigt.
Die Verwendung des Impella®-Systems durch geschulte und erfahrene
Ärzte ist mit besseren Ergebnissen verbunden. Daher sollte vor der
erstmaligen Verwendung des Impella Systems ein aktuelles Abiomed Impella
Schulungsprogramm absolviert werden. Bei der eigentlichen erstmaligen
klinischen Verwendung sollte eine Aufsicht durch Clinical Support-
Mitarbeiter von Abiomed erfolgen, die in der Verwendung der Impella
zertifiziert sind.
Die Einführung des Impella Führungsdrahts und des Impella 5.5
mit SmartAssist Katheter ist unter fluoroskopischer Durchleuchtung
durchzuführen.
Vermeiden Sie bei der Insertion eine manuelle Kompression des Einlasses,
des Auslasses sowie der Sensorbereiche des Kanülensystems des Impella5.5
Katheters.
Die sterilen Komponenten des Impella 5.5 System können nur
verwendet werden, die Verpackung nicht beschädigt ist und das
Mindesthaltbarkeitsdatum nicht abgelaufen ist.
Den Impella 5.5 mit SmartAssist Katheter NICHT resterilisieren
oder wiederverwenden. Es handelt sich um ein Einweggerät, das nur
für den einmaligen Gebrauch vorgesehen ist. Wiederverwendung,
Wiederaufbereitung oder Resterilisation können die strukturelle
Unversehrtheit des Katheters gefährden und/oder zum Versagen des
Katheters führen, was wiederum zu Verletzungen, Krankheit oder Tod des
Patienten führen kann.
Wenn der Impella 5.5 mit SmartAssist Katheter auf P-Level P-0 eingestellt
ist, kommt es zu einem retrograden Fluss über die Aortenklappe.
Verwenden Sie KEINE Kochsalzlösung im Purgesystem.
Verwenden Sie KEINE alkoholbasierten Flüssigkeiten für die Lubrikation.
Impella 5.5 mit SmartAssist System NICHT verwenden, wenn irgendein Teil
des Systems beschädigt ist.
Um eine Explosionsgefahr zu vermeiden, das Impella 5.5 mit SmartAssist
System NICHT in der Nähe von entflammbaren Anästhetika verwenden.
Wenn zu einem beliebigen Zeitpunkt während der Unterstützung mit dem
Impella 5.5mit SmartAssist Katheter der Automated Impella Controller
den Alarm „Purgedruck zu niedrig“ oder „Purgesystem ist offen“ anzeigt,
befolgen Sie die Anweisungen in dieser Gebrauchsanweisung.
MR-untauglich– Unterziehen Sie KEINE Patienten einer
Magnetresonanztomographie (MRT), die einen Impella 5.5 mit
SmartAssist Katheter implantiert haben. Durch die starke
magnetische Energie, die von MRT-Geräten ausgeht, können
Komponenten des Impella 5.5 Systems nicht mehr funktionieren
und zu Verletzungen des Patienten führen. Ein MRT kann zudem die
Elektronik des Impella 5.5 Systems beschädigen.
Berühren Sie während einer Defibrillation NICHT den Impella 5.5 mit
SmartAssist Katheter, die Kabel oder den Automated Impella Controller.
Vermeiden Sie eine zu tiefe Einführung des Impella 5.5 Katheters und das
mögliche Auftreffen der Katheterspitze auf die Wände von Gefäßsystem
oder Ventrikel.
Schieben Sie den Impella 5.5 mit SmartAssist Katheter NICHT gegen
Widerstand vor oder zurück, ohne mittels Fluoroskopie die Ursache für den
Widerstand bestimmt zu haben. Nichtbeachtung kann zur Abtrennung des
Katheters oder der Führungsdrahtspitze, Schäden am Katheter oder dem
Blutgefäß oder zu Ventrikelperforation führen.
VORSICHTSHINWEISE
Vorsichtsmaßnahmen weisen auf Situationen hin, in denen Geräte
Fehlfunktionen aufweisen, beschädigt werden oder den Betrieb einstellen
können. Das hellgraue Symbol wird vor Vorsichtshinweisen angezeigt.
Vorsichtig handhaben. Der Impella 5.5 mit SmartAssist Katheter kann
beim Entfernen aus der Verpackung, beim Vorbereiten, Einsetzen
und Entfernen beschädigt werden. Den Katheter und die Bauteile
KEINESFALLS biegen, ziehen oder übermäßigem Druck aussetzen.
Patienten mit Aortenstenosen oder anderen anormalen
Aortenklappenleistungen können durch die Verwendung des Impella
5.5 mit SmartAssist Katheter beeinträchtigt werden. Patienten mit
Aortenklappenleiden sollten auf Aorteninsuffizienz untersucht werden.
Verwenden Sie ausschließlich Originalzubehör und Ersatzteile von
Abiomed.
Um einen Geräteausfall zu verhindern, starten Sie den Impella 5.5 mit
SmartAssist Katheter NICHT vor dem Entfernen des Platzierungs-
Führungsdraht.
Den Impella 5.5 mit SmartAssist Katheter NICHT über die Länge des
Platzierungs-Führungsdraht hinaus entfernen.
Das Ersetzen der Purgekassette muss innerhalb von 90Sekunden
abgeschlossen sein. Der Impella 5.5 mit SmartAssist Katheter kann
beschädigt werden, wenn der Austausch länger als 90 Sekunden dauert.
Den Impella 5.5 mit SmartAssist Katheter an KEINEM Teil knicken oder
abklemmen.
Halten Sie für den unwahrscheinlichen Fall eines Geräteversagens
Ersatz für den Automated Impella Controller, die Purgekassette und den
Impella5.5 mit SmartAssist Katheter bereit.
VERWENDUNGSZWECK (EU)
VORGESEHENE VERWENDUNG IN DER EUROPÄISCHEN
UNION
Die Impella 5.5®mit SmartAssist®Herzpumpe ist eine intrakardiale Pumpe
zur Unterstützung des linken Ventrikels. Sie ist zur klinischen Verwendung
in der Kardiologie und in der Herzchirurgie vorgesehen, und zwar für bis zu
30Tage bei u. a. folgenden Indikationen:
• Das Impella 5.5 mit SmartAssist ist ein Kreislaufunterstützungssystem
für Patienten mit verringerter Linksherzfunktion, z.B.
Postkardiotomie, Low-Output-Syndrom, kardiogener Schock nach
akutem Myokardinfarkt.
• Die Impella 5.5 mit SmartAssist kann auch als kardiovaskuläres
Unterstützungssystem im Rahmen einer Koronar-Bypass-Operation
am schlagenden Herzen verwendet werden, insbesondere bei
Patienten mit einer eingeschränkten Auswurffraktion und einem
hohen Risiko eines postoperativen Low-Output-Syndroms.
DEUTSCH

Gebrauchsanweisung
KONTRAINDIKATIONEN (EU)
KONTRAINDIKATIONEN IN DER EUROPÄISCHEN UNION
Die Impella 5.5®mit SmartAssist®Herzpumpe ist in folgenden Situationen
kontraindiziert:
• Künstliche Aortenklappen, schwere Aortenklappenstenosen
• Hämatologische Erkrankung, die eine Instabilität der Blutkörperchen
oder eine Hämolyse verursacht
• Hypertrophische obstruktive Kardiomyopathie (HOCM)
• Aneurysma oder Nekrotomie oder schwere Anomalie der Aorta
ascendens und/oder des Aortenbogens
• Wandthrombus im linken Ventrikel
• Ventrikelseptumdefekt (VSD) nach Myokardinfarkt
• Anatomische Gegebenheiten, die die Einführung der Pumpe ausschließen
MÖGLICHE KOMPLIKATIONEN (EU)
Bei jedem Verfahren, bei dem eine Blutpumpe verwendet wird, können
Komplikationen auftreten. Dazu gehören u. a.:
• Hämolyse
• Blutung
• Immunreaktion
• Embolie, Thrombose
• Gefäßverletzung bis hin zu Angionekrotomie
• Positionierungsprobleme, die eine Hämolyse oder reduzierte
hämodynamische Unterstützung verursachen
• Infektion und Sepsis
• Lageveränderung der Pumpe
• Kardiovalvuläre Verletzungen aufgrund einer starken Bewegung
der Ansaugkanüle in Bezug auf die Herzklappe oder infolge der
Anhaftung der Pumpe an das Klappensystem aufgrund einer
Ansaugung nach einer falschen Platzierung
• Endokardiale Verletzungen infolge des Anhaftens der Pumpe
aufgrund von Ansaugung
• Pumpendefekt, Verlust von Pumpenkomponenten nach einem Ausfall
• Abhängigkeit des Patienten von der Pumpe nach Unterstützung
ÜBERSICHT
Der Impella 5.5 Katheter ist eine intravaskuläre Mikroaxial-Blutpumpe zur
Unterstützung des hämodynamischen Systems. Der Impella 5.5 Katheter wird
über einen Cut-Down der Arteria axillaris durch die Arterie und in den linken
Ventrikel eingeführt. Der Impella 5.5 Katheter kann auch chirurgisch über
einen direkten Zugang zur Aorta ascendens im Rahmen einer Sternotomie
oder Thorakotomie eingesetzt werden.
Bei richtiger Positionierung pumpt der Impella 5.5 Katheter Blut vom
Einlassbereich, der sich im linken Ventrikel befindet, durch die Kanüle zur
Auslassöffnung in der Aorta ascendens. Ärzte und Gerätebediener müssen
die richtige Position und Funktion des Impella 5.5 Katheters auf dem
Bildschirm des Automated Impella Controllers überwachen.
Dieser Abschnitt beschreibt die Komponenten des Impella®Katheters und des
Automated Impella Controllers sowie die Zubehörkomponenten.
WIEDERVERWENDBARE SYSTEMKOMPONENTEN
Das Impella 5.5 System besteht aus den folgenden wiederverwendbaren
Komponenten:
• Automated Impella Controller – stellt die Benutzeroberfläche,
Alarmanzeigen und einen tragbaren Akku zur Verfügung
• Automated Impella Controller-Wagen – für einen einfachen Transport
des Automated Impella Controller.
SYSTEMKOMPONENTEN FÜR DEN EINMALIGEN GEBRAUCH
Das Impella 5.5 mit SmartAssist System enthält außerdem die folgenden
Einwegkomponenten:
• Impella 5.5 mit SmartAssist Katheter
• Purgekassette
• Platzierungsführungsdraht (0,018Zoll, 260cm)
• Impella Kit zur axillaren Einführung
• Silikonstopfen
• Inzisionsschablone
SYSTEMKONFIGURATION
IMPELLA 5.5®MIT SMARTASSIST®
KATHETER
Der Impella 5.5 mit SmartAssist Katheter ist eine intravaskuläre Mikroaxial-
Blutpumpe, die bis zu 5,5 Liter Blut pro Minute vom linken Ventrikel in die
Aorta pumpt.
Purgeflüssigkeit
Automated Impella
Controller (AIC)
Impella 5.5
Katheter
Integriertes
Patientenkabel
Purgekassette
Glukose
GLUKOSE
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