###### AbioCor^®^ Implantable Replacement Heart

###### Instructions for Use

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###### Manufactured by ABIOMED, Inc.

**22 Cherry Hill Drive**

**Danvers, MA 01923**

**USA**

**978-777-5410**

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TABLE OF CONTENTS

[1. System Description 6](#system-description)

[1.1 Thoracic Unit 7](#thoracic-unit)

[1.2 Implanted Controller 7](#implanted-controller)

[1.3 Implanted Battery 7](#implanted-battery)

[1.4 Implanted TET 8](#implanted-tet)

[1.5 AbioCor Console 8](#abiocor-console)

[1.6 Patient Carried Electronics (PCE)
9](#patient-carried-electronics-pce)

[2. Indications and Contraindications for Use
11](#indications-and-contraindications-for-use)

[2.1 Indications for Use 11](#indications-for-use)

[2.2 Contraindications 11](#contraindications)

[3 Warnings 12](#warnings)

[4 Cautions 15](#cautions)

[5 Summary of Clinical Study 17](#summary-of-clinical-study)

[6 Patient Screening 19](#patient-screening)

[6.1 AbioFit 19](#abiofit)

[7 Implant Procedures 22](#implant-procedures)

[8 Operator's Manual (Summarized) 25](#operators-manual-summarized)

[8.1 Clinician's Manual 25](#clinicians-manual)

[8.2 Patient Manual 26](#patient-manual)

[8.3 Patient Carried Electronics 27](#patient-carried-electronics)

[8.4 Home User Training Program 27](#home-user-training-program)

[9 Patient Management 29](#patient-management)

[9.1 Anticoagulation Management 29](#anticoagulation-management)

[9.2 Infection Management 30](#infection-management)

[9.3 Rehabilitation 30](#rehabilitation)

[9.4 Hospital Discharge 31](#hospital-discharge)

[9.5 Facility Requirements 33](#facility-requirements)

[9.6 Equipment Requirements 33](#equipment-requirements)

[9.7 Patient requirements for discharge
33](#patient-requirements-for-discharge)

[9.8 Steps for Discharge to Intermediate Care Facility
35](#steps-for-discharge-to-intermediate-care-facility)

[9.9 Steps for discharge to home 36](#steps-for-discharge-to-home)

[10 Outline of Clinician training Program
39](#outline-of-clinician-training-program)

[10.1 Introductory Class room session and workshop
39](#introductory-class-room-session-and-workshop)

[10.2 Pre-Animal Lab training 40](#pre-animal-lab-training)

[10.3 Animal Lab / Peer Visit 40](#animal-lab-peer-visit)

[10.4 Subsequent Animal Labs 40](#subsequent-animal-labs)

[10.5 Post-operative care team training
41](#post-operative-care-team-training)

[10.6 Step-down unit training 41](#step-down-unit-training)

[10.7 Criteria for Clinical Readiness from Training Sessions
41](#criteria-for-clinical-readiness-from-training-sessions)

[11 System components 42](#system-components)

[11.1 Implantable Kit 42](#implantable-kit)

[11.2 Console Kit 42](#console-kit)

[11.3 PCE and Home Kit 43](#pce-and-home-kit)

[12 Materials Matrix 44](#materials-matrix)

[12.1 Thoracic Unit 44](#thoracic-unit-1)

[12.2 Implantable Battery and Controller
44](#implantable-battery-and-controller)

[12.3 Implantable TET 44](#implantable-tet)

[12.4 External TET 44](#external-tet)

#  {#section-13 .unnumbered}

#  System Description

The AbioCor System is intended to replace the patient's natural heart.
It is designed for patients whose hearts are irreparably damaged or who
are at imminent risk of death by heart failure.

The System can be divided into the Implanted system (Figure 1-1) and the
External system. The Implanted system consists of the Thoracic Unit, the
Implanted Controller, the Implanted TET, and the Implanted Battery. The
External system consists of the AbioCor Console and the Patient Carried
Electronics (PCE).

![](media/image1.jpeg){width="6.197916666666667in"
height="4.648611111111111in"}

Figure 1-1 The AbioCor Implanted System; A- Thoracic Unit, B- Implanted
Controller , C- Implanted Battery, C- Implanted TET.

##  Thoracic Unit

![](media/image2.png){width="3.265277777777778in" height="1.88125in"}

The Energy Converter moves hydraulic fluid from one side to the other,
squeezing the sac in one pump and forcing blood out of it.
Simultaneously, blood is actively drawn into the other pump, filling it
for the next cycle. The Energy Converter pumps hydraulic fluid in each
direction alternately so that the left and the right blood pump
alternately fills and ejects blood.

##  Implanted Controller

The Implanted Controller is the brain of the implanted System. It
performs several functions:

-   monitoring of the Thoracic Unit and the other implanted components

-   control of the Thoracic Unit

-   communication with the external components and alarms (the AbioCor
    Console or Patient-Carried Electronics)

The Implanted Controller contains the control electronics in a
hermetically sealed titanium case. It is implanted abdominally, outside
the peritoneum, on the patient's left side between the sub-costal and
iliac regions.

##  Implanted Battery

The Implanted Battery, when new and fully charged, contains enough
electrical energy to drive the AbioCor System for approximately 60
minutes with no external power supply. This allows the patient to
function without a Console or PCE for short periods. The actual time of
operation on the Implanted Battery depends on the age and charge of the
battery and on the blood flow rate provided by the AbioCor System.

The Implanted Battery is implanted abdominally, outside the peritoneum,
on the patient's right side between the subcostal and iliac region. In
this location, the battery can be replaced by a minor surgical
procedure. Because the AbioCor System can get power externally, through
the TET, the battery can be replaced without interrupting the operation
of the AbioCor System.

The Implanted Battery recharges automatically whenever the implantable
components are drawing power from the TET.

##  Implanted TET

The Implanted TET receives electrical energy in the form of radio waves
from the External TET and converts it to the DC power used by the rest
of the AbioCor System.

The Implanted TET is positioned in a subcutaneous pocket, usually in a
sub-clavicular location. The details of the location depend on the
patient's size and other anatomical considerations.

The Implanted TET is the primary power source for the AbioCor System's
implanted components. Because the radio waves used can pass through a
small thickness of human tissue, no percutaneous connections are needed.
In addition, the Implanted TET can transmit an alarm signal when the TET
Alarm Channel is in use.

## ![](media/image3.jpeg){width="2.0in" height="1.6354166666666667in"}AbioCor Console

The AbioCor Console (Figure 1-3) is the primary external component of
the AbioCor System. It serves as the primary user interface in the
clinical setting and provides power and data communications to the
internal components, and is the interface for other patient monitoring
equipment, data logging, networking, remote monitoring by ABIOMED, and
other external functions. The Console transmits power via the TET, and
communicates via the RF Communications Module.

## Patient Carried Electronics (PCE)

![](media/image4.png){width="2.1173611111111112in" height="2.75in"}

![](media/image5.jpeg){width="4.364583333333333in"
height="3.5729166666666665in"}

The relationship of the internal (implanted) components and the External
components are illustrated in Figure 1-6. The Implanted components
receive power and user command signals from either the AbioCor Console
or the Patient-Carried Electronics (PCE).

![](media/image6.png){width="4.113888888888889in"
height="3.5902777777777777in"}

# 2. Indications and Contraindications for Use {#indications-and-contraindications-for-use .unnumbered}

##  Indications for Use

> The AbioCor is indicated for use in severe end stage heart disease
> patients who

-   Are less than 75 years old,

-   Are not transplant candidates at the time of assessment,

-   Require multiple inotropic support,

-   Are in biventricular failure not treatable by LVAD destination
    therapy,

-   Are not weanable from biventricular support if on such support and
    not awaiting transplantation.

##  Contraindications

> Contraindications include patients

-   With other irreversible end organ functions that would compromise
    survival,

-   With inadequate psychosocial support

-   In whom preoperative noninvasive anatomical assessment reveals
    inadequate fit.

# Warnings

**NOTE:** A warning indicates a situation that could result in injury or
death.

-   Do **NOT** subject a patient who has been implanted with an
    AbioCor^®^ System to Magnetic Resonance Imaging (MRI). The strong
    magnetic energy produced by an MRI machine can cause the AbioCor
    System components to stop working. An MRI can also damage the
    AbioCor System's electronics.

-   Do **NOT** allow any metal objects within **3 inches** of the
    External Transcutaneous Energy Transmission coil (External TET)
    while it is connected to the Console or the PCE Module. Certain
    types of metal objects can quickly become extremely hot and present
    a burn or fire hazard.

-   Do **NOT** place an External TET that is connected to the Console or
    the PCE Module within **3 inches** of a metal surface. The TET can
    become overheated, causing a fire hazard.

-   Keep the External TET disconnected from the Console when it is not
    in use. This reduces the risk of creating a fire hazard and damaging
    the TET because of the TET accidentally being too close to a metal
    surface.

-   The TET cable becomes warm during normal operation. If the cable
    becomes hot, replace the External TET. A hot cable may present a
    burn hazard.

-   Do **NOT** administer cardiopulmonary resuscitation (CPR) to a
    person who has an AbioCor System. CPR will not work and may cause
    life-threatening bleeding.

-   Many conditions that occur during the operation of the AbioCor
    System can trigger AbioCor System alarms. Do **NOT** operate the
    AbioCor System without training in reacting to these alarms. Injury
    or death may result if the alarms are not handled in a timely and
    appropriate manner.

-   Do **NOT** allow a patient who has an AbioCor® System to travel to
    an altitude that is more than 2,500 feet higher or lower than the
    location at which the AbioCor System was implanted. If emergency air
    transportation is needed, tell the pilot about the 2,500-foot
    restriction. Changes in air pressure caused by altitude changes may
    cause the AbioCor System to work incorrectly, resulting in injury or
    death.

-   Do **NOT** submerge a patient who has an AbioCor System more than 2
    feet below the surface of any body of water. The change in pressure
    that occurs underwater may cause the AbioCor System pressure
    measurements to be inaccurate and result in improper operation.

-   Monitor the temperatures of the Implanted Controller, Implanted TET,
    and Implanted Battery by checking the Parameter Window, which is
    available at Show Param Window on the Main Menu. Patient complaints
    of a localized feeling of heat may indicate that one of these
    components is not operating properly or is operating outside of its
    intended range.

-   Monitor the patient closely for signs of sepsis. Infections may make
    blood more prone to clotting, increasing the risk of cerebrovascular
    accident (CVA).

-   Maintain a therapeutic level of anticoagulation to decrease the risk
    of thrombus formation.

-   A person who has an AbioCor System must **NOT** do deep forward
    bends. These may cause discomfort or pain because of the rigid
    AbioCor components and may reduce blood flow resulting in low blood
    pressure, and fainting.

-   When using an X-ray lead shielding apron, be sure to place a pad
    (such as Styrofoam® or towels) at least 3 inches thick between the
    External TET and the shielding apron. This prevents heating of the
    shielding apron.

-   Do **NOT** use a Swan-Ganz® catheter or other catheters to measure
    blood pressure within the Thoracic Unit. Cardiac catheters can
    damage the blood-contacting surfaces in the Thoracic Unit and
    promote thrombus buildup.

-   During clinical use, a spare AbioCor^®^ Console or a PCE / Handheld
    monitor must be available at all times.

-   Do **NOT** mask (disable) any alarms without **authorization**.
    Alarm masking can affect patient safety.

-   Waveforms and values from patient monitoring equipment are intended
    only for data collection. Do **NOT** use this information for
    patient management.

-   To prevent the risk of explosion, do **NOT** operate the Console
    near flammable anesthetics.

-   To reduce the risk of electric shock, do **NOT** attempt to remove
    the Console housing or replace the Console Battery.

# Cautions

**NOTE:** A caution indicates a situation in which equipment may
malfunction, be damaged, or cease to operate.

-   To prevent overheating and improper operation, do **NOT** block the
    AbioCor^®^ Console cooling vents while the Console is operating.
    Blocked cooling vents can cause the Console to overheat and to work
    incorrectly.

-   When using the Console on a soft or uneven surface, use the foldout
    stand to help maintain adequate clearance around the vents.

-   Keep an External TET that is connected to the Console at least 1
    foot away from any other External TET. TET electronics can be
    damaged if TETs are too close to each other.

-   Do **NOT** clean the External TET, Radio Frequency (RF)
    Communications Module, or cables with disinfectants that contain
    oxidizers such as iodine (Betadine^®^ or similar disinfectants),
    hydrogen peroxide, hypochlorite (chlorine bleach), permanganate, or
    chromate. These cleaners may break down the outer coverings of these
    components.

-   Do **NOT** use cleaners that may stain the outer coverings of
    components and hide the breakdown of these coverings.

-   Do **NOT** resterilize the External TET or cables. Additional
    sterilization can permanently damage these components.

-   Do **NOT** allow any liquids (including water) to come in contact
    with any electrical connector pins. Contact with liquid can cause
    corrosion or electrical malfunction.

-   When possible, maintain the data connection between the Console and
    ABIOMED. The information collected will assist clinicians in
    ensuring proper operation of the AbioCor® System and in analyzing
    alarms.

-   Minimize exposure of AbioCor® 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 AbioCor System components and the EMI source or turn off the
    EMI source.

-   Operation of AbioCor System components may interfere with the
    operation of other devices. If interference occurs, increase the
    distance between the device and AbioCor System components.

# Summary of Clinical Study

> The clinical trial with the AbioCor spanned the time period between
> July 2001 and November 2004. Fourteen patients with end-stage heart
> failure and no other treatment options were implanted with the
> AbioCor, a fully implantable replacement heart device. Candidates
> enrolled in the trial had a one-month survival prognosis of not more
> than 30%. Candidates were not transplant eligible and were those who
> could not benefit from destination LVAD support.
>
> An independent patient advocate group consisting of members devoted to
> end of life patient management was instituted to help patients and
> their family with the Informed consent process and the challenges and
> risks associated with living and dying on an experimental device. The
> trial was initially designed to assess patient survival at two months.
> The incremental gate for trial continuation in each group of five
> patients was based on one of five patients surviving to 60 days.
> Candidates and family members understood the trial criteria and the
> risks of prolonged recovery, complications of bleeding, stroke, pain,
> living and dying on the device.
>
> Twelve patients of the fourteen candidates survived surgery,
> representing an 86% success rate for a radically new procedure.
> Support duration of the twelve patients ranged from 53 to 512 days.
> The majority of the patients (71%) survived beyond the 60 day
> milestone set for one of five patients (20%). The mean duration of
> support for the supported patients was 5.3 months. The cumulative
> support time was 64 patient-months substantially greater than
> initially anticipated.
>
> Many of the patients had renal and hepatic dysfunctions associated
> with pre-existing debilitating conditions. As with all mechanical
> support devices, complications included post-operative bleeding
> requiring re-operation for resolution, and neurological events. The
> propensity for bleeding further challenged the need for some level of
> anticoagulation management desirable to minimize neurological
> complications. One anticipated device wearout occurred at 17 months. A
> device failure occurred at 5 months. Corrective actions have been
> implemented for these problems. In contrast to other mechanical
> cardiac support devices, device related infection was non-existent due
> primarily to its full implantability, eliminating the special
> attention needed for exit site care and the risks for infection.
>
> Six patients were ambulatory. Four patients have had excursions
> outside of the hospital, and two of these four patients were
> discharged to facilities near the hospital as intermediary steps
> toward final discharge to home. One of these two patients was
> discharged to home shortly thereafter. The other discharged patient
> returned to the hospital while home readiness preparation and home
> care arrangements were being made for discharge to home. Discharge
> protocol was developed as needed since discharge was not anticipated
> for patient this initial trial. Three patients were able to go to
> restaurants, attend shows, sporting events, and religious services,
> and visit family and friends at their homes. Such activities have been
> conducted with wearable external components allowing for freedom and
> mobility. Six patients celebrated their next birthdays on the AbioCor.
> One patient became a great-grandfather while on the AbioCor.

# Patient Screening

> Patients being considered for the AbioCor should, have the following
> screening tests administered, and these results will be reviewed by
> the medical team. Screening data will be used to assess whether a
> candidate meets the inclusion and exclusion criteria.

-   Echocardiogram- for Ejection Fraction

-   MRI / CT for atrial size determination for the assessment of
    biventricular failure

-   Inotopes used and dosages

-   Other support -- IABP

-   Doppler exam of the Carotid and Femoral Arteries, and veins

-   Patient meets inclusion criteria

-   Hematology workup

-   Hemodynamics, including PCWP

-   Medical history

-   Social support system

-   KCCQ evaluation

##  AbioFit

### CT scan procedure

1.  **Two sets of transverse scans should be obtained:**

> a\. Thoracic and upper abdominal scans: from the jugular notch of
> manubrium to the iliac crest.
>
> b\. Head scan.

2.  **Scan resolution (slice thickness):**

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a.  Uniform slice thickness for the entire scan. A constant thickness
    between 2 and 5 mm can be selected.

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3.  **Breathing cycle (preferred):**

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a.  For the thoracic scan, the patient should hold breath while fully
    exhaled.

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4.  **Scan quality:**

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a.  Enhance the contrast to highlight the Pulmonary Veins and better
    define the great vessels and the cardiac chambers.

b.  Delay placement of catheters, if possible, until after the scan to
    avoid image distortion.

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5.  **File format:**

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a.  DICOM. Should contain calibration scale information for each axis.
    Do not send encrypted or compressed files e.g. the Toshiba scanner
    output file.

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6.  **Scan transfer media**

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a.  FTP to password protected Abiomed site: gatekeeper.abiomed.com

b.  Compact Disk

c.  Optical Disk

d.  DVD

> Scanner types that have been verified to work with the Mimics program
> are:

a.  Philips MRI (ASCNT 1.5)

b.  GE MRI (Horizon 1.5)

c.  Picker CT (PQ-5000 & -6000)

d.  GE HiSpeed

e.  Siemens Somatom Volume Zoom (uncompressed file format only)

### AbioFit

The primary purpose of the AbioFit program is to provide a tool to allow
for a pre-assessment of the anatomic fit of the AbioCor in a recipient
candidate prior to surgical implantation of the device. Such a tool
reduces the possibility of fit related issues during surgery. The
program uses two dimensional scans of either CT or MRI images of
patients to construct a three dimensional representation of the organs
within the contour of the chest cavity. Each major organ or portion of
an organ can be further identified as an integral unit to permit virtual
"surgical" removal of this part.

A three dimensional model of the AbioCor Thoracic Unit is stored in the
program. The AbioFit operator removes the pericardium and the
ventricles, and then using various editing tools places the AbioCor
model into the vacated space.

The entire anatomy can be manipulated in space in order to facilitate
viewing from any orientation. The final assessment of fit can be
determined by stepping through two dimensional slices of the original
scans with the superimposed device boundaries. This final step provides
a close-up determination of interference with adjacent organs at all
pertinent cranial-caudal levels. In addition to anemometrical fit,
AbioFit will be used to assess candidate's native atrial volume. The
criteria for good fit includes:

1.  Proper alignment of the inflows with the mitral and tricuspid valve
    planes without compression of the atria, of the right outflow, or
    the pulmonary artery.

2.  Non-interference with the descending aorta and the pulmonary veins

3.  The device remains completely within the rib cage.

4.  Adequate atrial volume

.

#  {#section-14 .unnumbered}

### ![](media/image7.png){width="1.9291666666666667in" height="2.25in"}AbioFit Operation

CT or MRI scans of a potential subject are obtained from a clinical
center in the form of CD's, DVD, optical disks, Zip disks, or via the
internet using FTP. Once the scans are imported into the AbioFit
software tool, the cranial-caudal series of scans are treated as stacks
in memory in the appropriate anatomical sequence.

With integral parts identified, Mimics can perform virtual surgery by
peeling off layers to reveal the internal organs.

The AbioCor is placed into the AbioFit software as a

Graphic file Figure 6-1 shows the AbioCor after it has been aligned in
the three dimensional reconstruction.

The viewing angle can be chosen by rotating the entire 3-d
reconstruction to verify that proper placement of the AbioCor is
achieved

Once an acceptable placement is achieved, a more detailed verification
of fit can be viewed on 2-d slices with the AbioCor superimposed on the
original scans.

#  {#section-15 .unnumbered}

# Implant Procedures

##  Preparation {#preparation .steve}

## Perform Pre-implant check-out of all AbioCor equipment. {#perform-pre-implant-check-out-of-all-abiocor-equipment. .Steve_List}

## AbioCor Console setup {#abiocor-console-setup .Steve_List}

## Implanted System check-out in a sterile field {#implanted-system-check-out-in-a-sterile-field .Steve_List}

## System Operation verification {#system-operation-verification .Steve_List}

## TET and Charging System operational check {#tet-and-charging-system-operational-check .Steve_List}

##  Implantation {#implantation .steve}

> A fully detailed implant procedure is described in the manual
> "Pre-implant Equipment Check and Implant Procedures". (Document \#
> 0034-0980-00013)

1.  Using blunt dissection, form a pocket for the Implantable TET on the
    right-hand side in subclavicular tissue from the sternal incision
    site. Place the TET in the pocket (about ½ inch deep). Tunnel the
    TET cable over the ribs and out through the sternotomy incision.
    Form pockets for the Implantable Controller and Implantable Battery
    below the posterior sheath of the peritoneum.

2.  Remove the ventricles. Cut the tissue between the atria and
    ventricles leaving adequate left and right atrial tissue for
    attaching inflow cuffs.

3.  Cut the tissue between the ventricles and the aorta and pulmonary
    artery (PA) distal to their respective valves. Trim or over sew
    excess tissue on the atrial appendages to prevent possible prolapse
    into the inflow valves.

4.  Trim the left atrial cuff to the appropriate size. Then sew the cuff
    to the left atrial tissue and to a reinforcing layer of PTFE felt
    using a running polypropylene suture. Reinforce the anastomosis by
    sewing a second layer of felt around it. Check the right and left
    atrial anastomosis for leaks using the leak checkers provided.

5.  Trim the PA outflow graft to the appropriate length and sew to the
    PA using a running suture and a reinforcing layer of PTFE felt.

6.  Trim the aortic outflow graft to the appropriate length and sew to
    the aorta using a running suture and a reinforcing layer of PTFE
    felt. Check the anastomosis for leaks using the leak checker without
    the Foley catheter.

##  Placing the Thoracic Unit {#placing-the-thoracic-unit .steve}

## Fill the blood pumps with heparinized saline, and place the Thoracic Unit in the pericardial space.  {#fill-the-blood-pumps-with-heparinized-saline-and-place-the-thoracic-unit-in-the-pericardial-space. .Steve_List}

## Make the connections to the cuffs and grafts. {#make-the-connections-to-the-cuffs-and-grafts. .Steve_List}

##  De-Airing and Start-up {#de-airing-and-start-up .steve}

## Connect the yellow connector of the Implantable Cable to the yellow connector of the Thoracic Unit and tighten with the spanner wrench. {#connect-the-yellow-connector-of-the-implantable-cable-to-the-yellow-connector-of-the-thoracic-unit-and-tighten-with-the-spanner-wrench. .Steve_List}

## Attach Toomey syringe bodies to the side arms of the outflow grafts and place suckers in the syringe bodies. {#attach-toomey-syringe-bodies-to-the-side-arms-of-the-outflow-grafts-and-place-suckers-in-the-syringe-bodies. .Steve_List}

## Release the caval tapes and allow the right atrium to fill. Partially occlude the venous return to the bypass machine. {#release-the-caval-tapes-and-allow-the-right-atrium-to-fill.-partially-occlude-the-venous-return-to-the-bypass-machine. .Steve_List}

## Fill the Thoracic Unit by increasing central venous pressure (CVP) to 15 to 20 mmHg. Maintain CVP within this range during the de-airing procedure. {#fill-the-thoracic-unit-by-increasing-central-venous-pressure-cvp-to-15-to-20-mmhg.-maintain-cvp-within-this-range-during-the-de-airing-procedure. .Steve_List}

## Begin with the low-flow Start Up states and quickly step through the first 3 states (if there are no filling problems).  {#begin-with-the-low-flow-start-up-states-and-quickly-step-through-the-first-3-states-if-there-are-no-filling-problems. .Steve_List}

## When all air has been removed from the right blood pump, clamp the right side arm. {#when-all-air-has-been-removed-from-the-right-blood-pump-clamp-the-right-side-arm. .Steve_List}

## Inspect the left blood pump and valves for air. After satisfactory inspection, allow an additional 4 to 5 minutes to ensure that the left blood pump is de-aired.  {#inspect-the-left-blood-pump-and-valves-for-air.-after-satisfactory-inspection-allow-an-additional-4-to-5-minutes-to-ensure-that-the-left-blood-pump-is-de-aired. .Steve_List}

##  Transition from CPB to AbioCor  {#transition-from-cpb-to-abiocor .steve}

## Reduce TU beat rate to 60 bpm and CPB flow down to 1 liter of flow. {#reduce-tu-beat-rate-to-60-bpm-and-cpb-flow-down-to-1-liter-of-flow. .Steve_List}

## Simultaneously clamp the left side arm and open the cross clamp. Do not allow the side arm and the cross clamp to be closed at the same time. {#simultaneously-clamp-the-left-side-arm-and-open-the-cross-clamp.-do-not-allow-the-side-arm-and-the-cross-clamp-to-be-closed-at-the-same-time. .Steve_List}

## Closely monitor inflow pressures and compensate by making changes to volume and Thoracic Unit settings. {#closely-monitor-inflow-pressures-and-compensate-by-making-changes-to-volume-and-thoracic-unit-settings. .Steve_List}

## Discontinue CPB and reverse heparin. {#discontinue-cpb-and-reverse-heparin. .Steve_List}

## Increase TU beat rate to desired blood flow, making sure that filling pressure remain between 15 and 20 mmHg. {#increase-tu-beat-rate-to-desired-blood-flow-making-sure-that-filling-pressure-remain-between-15-and-20-mmhg. .Steve_List}

##  Chest Closure {#chest-closure .steve}

## Baseline fit assessment of the AbioCor is essential to ensure the device can perform according to specifications. A major cause of performance problems is limited blood flow to the right or left ventricle. Every effort should be made to ensure there are no fit complications. The following recommendations are intended to help minimize this problem: {#baseline-fit-assessment-of-the-abiocor-is-essential-to-ensure-the-device-can-perform-according-to-specifications.-a-major-cause-of-performance-problems-is-limited-blood-flow-to-the-right-or-left-ventricle.-every-effort-should-be-made-to-ensure-there-are-no-fit-complications.-the-following-recommendations-are-intended-to-help-minimize-this-problem .Steve_List .unnumbered}

## After the AbioCor is providing full support to the patient (and hemodynamics are stable with the chest open), baseline data should be collected. This data take into account patient variables, such as atrial size, pulmonary resistance, systemic resistance, and anatomical issues: {#after-the-abiocor-is-providing-full-support-to-the-patient-and-hemodynamics-are-stable-with-the-chest-open-baseline-data-should-be-collected.-this-data-take-into-account-patient-variables-such-as-atrial-size-pulmonary-resistance-systemic-resistance-and-anatomical-issues .Steve_List}

## TEE should be recorded, showing acceptable pressure gradients (not exciding twice normal) between the pulmonary veins and the left atrium. {#tee-should-be-recorded-showing-acceptable-pressure-gradients-not-exciding-twice-normal-between-the-pulmonary-veins-and-the-left-atrium. .Steve_List}

## Hemodynamic parameters should be recorded, evaluating device output, central venous pressure, left atrial pressure, and aortic pressure. If possible, these numbers should be recorded at various central venous pressure levels to allow graphing of the device output response. {#hemodynamic-parameters-should-be-recorded-evaluating-device-output-central-venous-pressure-left-atrial-pressure-and-aortic-pressure.-if-possible-these-numbers-should-be-recorded-at-various-central-venous-pressure-levels-to-allow-graphing-of-the-device-output-response. .Steve_List}

## After the baseline fit assessment is complete, the chest should be approximated in the closed position. TEE and hemodynamic parameters should be reassessed, and a target velocity of \< 80 cm/second should be maintained. {#after-the-baseline-fit-assessment-is-complete-the-chest-should-be-approximated-in-the-closed-position.-tee-and-hemodynamic-parameters-should-be-reassessed-and-a-target-velocity-of-80-cmsecond-should-be-maintained. .Steve_List}

#  Operator's Manual (Summarized)

##  Clinician's Manual

This Clinician Manual is designed for experienced health care
professionals responsible for patients implanted with an AbioCor
Implantable Replacement Heart. This manual contains clinical and
technical considerations to guide care for these patients. Clinicians
should have extensive experience in the care and management of
postoperative cardiac surgical patients including those requiring
mechanical circulatory assist devices.

Information and instructions given in this 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.

This manual should be used to support patients before and after
implantation.

**Manual overview**

This Clinician Manual provides instructions for use of the AbioCor
Implantable Replacement Heart System. This manual also includes
important information concerning patient monitoring. The following
summarizes the contents of each section of this manual:

-   **Section 1 (Warnings and Precautions)** discusses the warnings and
    precautions pertaining to the use of the AbioCor System.

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-   **Section 2 (Indications and Potential Adverse Events)** discusses
    indications for use of the AbioCor System and potential adverse
    events that may be associated with its use.

-   **Section 3 (The AbioCor System**) provides an overview of the
    AbioCor System and describes the system's major internal (implanted)
    and external components.

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-   **Section 4 (Using the AbioCor Console)** describes the procedures
    for setting up and operating the AbioCor Console.

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-   **Section 5 (Using the Console in Clinical Mode)** describes where
    to find information available in Clinical Mode and how to use and
    navigate through the Clinical Mode windows and popup dialogues.

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-   **Section 6 (Managing an Implanted AbioCor System)** presents the
    information on power management, TET management, communications
    management, and hemodynamic management to aid in managing an AbioCor
    System that is implanted in a patient.

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-   **Section 7 (Caring for a Patient with an Implanted AbioCor
    System)** describes considerations and procedures for caring for
    patients with implanted AbioCor Systems.

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-   **Section 8 (Transitioning the AbioCor Patient to Home Living)**
    describes discharge planning and procedures, including home
    caregiver and patient training requirements.

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-   **Section 9 (Alarms)** describes the AbioCor alarm and warning
    system.

##  Patient Manual

The patient manual will help the patient and caregiver understand how to
live comfortably with the AbioCor Replacement Heart. The manual includes
information about how the AbioCor System works in the body and how it
fits into the patients daily routine. The manual also instructs users in
how to adjust the system and when to call the doctor or the clinic.

**Manual Overview**

-   **Section 1** lists important warnings and precautions to avoid
    potential safety problems and ensure that the best results from your
    AbioCor System.

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-   **Section 2** describes the parts of the AbioCor System and how they
    work together to keeps blood flowing normally.

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-   **Section 3** is about daily living with the AbioCor Replacement
    Heart, on nutrition, sleep, exercise, shower, travel, and maintain
    other daily routines.

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-   **Section 4** tells how to connect and operate the external controls
    of the AbioCor System, using the Console.

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-   **Section 5** tells how to transfer control from the AbioCor Console
    to the Patient-Carried Electronics unit when more freedom of
    movement is desired.

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-   **Section 6** provides an overview of the AbioCor alarms.

##  Patient Carried Electronics

The Patient Carried Electronics (PCE) manual provides information to
help the patient and caregiver understand how to use the PCE and Hand
Held Alarm Monitor safely and comfortably.

**Manual Overview**

-   **Section 1 (Warnings and Precautions)** lists important precautions
    to avoid potential safety problems.

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-   **Section 2 (PCE Overview)** describes the function of the
    Patient-Carried Electronics (PCE).

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-   **Section 3 (Basic PCE Operation)** shows how to use the PCE and how
    to charge, and replace batteries. It also shows how to keep the unit
    clean.

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-   **Section 4 (Transferring Support Between the Console and PCE)**
    tells how to transfer support from the AbioCor Console to the PCE
    when you want to be away from the Console **and how to transfer
    support from the PCE back to the Console.**

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-   **Section 5 (PCE Alarms)** describes the alarms you would see and
    hear when you are using the PCE.

##  Home User Training Program

The transition to home living with the AbioCor involves careful
preparation and assessment of the patient, the caregivers, and the
patient's home environment and support structure. Patient and caregiver
training are essential for a safe and successful discharge experience.
Before discharge from the hospital, the AbioCor patient and their
respective caregivers will be trained by the AbioCor Center's staff.
Proficiency on each training requirement listed below will be based on
observational testing. The AbioCor patient and their respective
caregivers should be capable of operating the AbioCor system and feel
completely comfortable in their ability to address and respond to each
function defined in the training requirements of the AbioCor system.

The Trainer will document each training requirement when addressed and
proficiency established.

-   Identify the AbioCor System Components and Functions

-   Understand and Identify the AbioCor console controls and indicators.

-   Use the AbioCor Controls in Home Operating Mode

-   Understand and respond to AbioCor Console Alarms

-   Understand and use of the External Transcutaneous Energy
    Transmission coil (External TET)

-   Understand and establish RF communications

-   Understand and use of the Patient Carried Electronics (PCE)

-   Understand Emergency Procedures

-   Understand and demonstrate the importance of their medications and
    self care.

#  Patient Management

##  Anticoagulation Management

-   ABIOMED recommends that the immediate post-operative cardiac index
    should be set above 2.5 L/min/M^2^ but should not exceed 3.0
    L/min/M^2.^

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-   Heparin therapy is initiated only after surgical hemostasis has been
    verified.

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-   Starting dose should be within 2 -- 5 Units/kg/hr with target PTT
    being around 2.5 times normal. (55 -60 sec)

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-   The heparin drip will be titrated to achieve normal coagulability as
    indicated by TEGs using the sample without heparinase in recalcified
    whole blood to assess the heparin effect

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-   Warfarin therapy will be initiated when renal and hepatic functions
    improve, and prealbumin levels increase and nutritional status
    becomes stable.

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-   Target INR should be between 2.5 to 3.5.

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-   TEGs should be used to detect normocoagulability. While warfarin is
    taking effect, heparin should be titrated down, guided by TEGs.
    Heparin is discontinued when normocoagulability with heparinase has
    been achieved for 2 consecutive days indicating that the coumadin
    effect has taken hold.

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-   Antiplatelet therapy will be achieved with aspirin, dipyridamole,
    and/or Plavix.

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-   Asprin 81 -- 325 mg/day

-   Dipyridamole 75mg Q6

-   Plavix 75 mg/day

-   Platelet aggregation should be used to achieve 50% inhibition

-   TEG with platelet agonist should be used for platelet function
    assessment.

**Summary of Post-Operative Dosage and Monitoring Guidelines**

##  Infection Management

Antibiotic therapy should be provided prophylactically from the recovery
to the step down phases of AbioCor support. Longer duration and or
organism specific medication administration is at the discretion of the
clinician.

To minimize the chance of infection, indwelling lines should be
discontinued as soon as possible. The Millar Left atrial line may be
left for longer periods of time at the discretion of the physician. All
discontinued line tips should be sent for routine culture.

The patient will have at the minimum the following incisions and line
insertion sites:

-   A median sternotomy,

-   chest tube,

-   central line,

-   radial or femoral arterial line insertion sites.

Strict ascetic technique should be used for all dressing changes.
Dressing changes should be done according to ICU policy and protocol, or
per the physician's orders. It is recommended that dressings are in
place during the patient's intubation phase, to prevent wound
contamination. If the patient requires prolonged ventilatory support, or
tracheostomy, the need for dressings should be at the physician's
discretion. The incisions may be open to air after the patient is
extubated, and the wounds are healed.

Nutrition is a major factor in preventing infection. Baseline nutrition
values should help direct therapy. Tube feedings may be necessary to
supplement some patient needs. Infection should be suspected if any of
the following occurs, WBC increase, temperature increase, positive
cultures, infiltrate on x-ray, skin redness, pain/tenderness and any
significant decrease in blood pressure at the same device output.

##  Rehabilitation 

Once the patient is hemodynamically stable, progressive activity as per
a physical therapy plan should be initiated including:

-   Turning side to side every two hours.

-   Passive and active range of motion.

-   Elevating the head of the bed.

-   Dangling at the side of the bed.

-   Out of bed to a chair.

-   Ambulating with, and eventually without assistance.

The patient should be introduced to use the Patient Carried Electronics
soon after as he begins to ambulate. A gradual increase in the total
weight of the PCE Module and two battery packs that must be borne by the
patient can be gradually increased per the physical therapists
discretion, until he is able to carry all of the electronics himself.

##  Hospital Discharge

To ensure the safety of the patient, primary care givers and if possible
the patient must:

-   Complete the training and demonstrate knowledge of operating and
    troubleshooting the Abercorn system and responding to possible
    emergencies.

-   Have the required emergency and back-up information, equipment, and
    accessories.

If the patient is stable with normal homodynamic and the patient or
family is capable of taking charge of the care plan, discharge to an
"intermediate" facility near the hospital can be considered.

If in the opinion of the clinical team that the patient and family
support group has demonstrated their ability to care for the patient and
the Abercorn system. The patient can be discharged to home provided the
following sequence of events has occurred.

Preparation for discharge is an on going activity; it should begin when
the patient is transferred out of the ICU, and include the patient and
the patient's primary caregivers. The plan is developed around restoring
the patients physical condition to a point in which they can participate
in there own care, and to transition the care of the patient and the
AbioCor system from the hospital staff to the caregivers. A general
outline of events leading to discharge would include:

1.  1\. Increasing physical activity in the step down unit including:

-   Patient transferring from bed to chair without assistance

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-   Patient able to care for personal hygiene

2 In hospital excursions, for example:

-   To the hospital cafeteria

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-   To outside areas such as roof decks and gardens.

> 3 Out of hospital excursions, for example:

-   Local restaurants and parks

4.  Day trips to Intermediate care facility such as a local hotel or
    apartment close

> to the medical center.

5.  Over night stays at the intermediate care facility.

6.  Discharge to home

##  Facility Requirements

There are no special requirements on the power needs in the home or the
work environment. For travel in a car, the number of battery packs to be
carried in the car should be equivalent to twice the number of hours for
the roundtrip. A console should also be part of the traveling
accessories to allow for data monitoring. It also serves as a backup to
the PCE.

The Local EMS service should be notified of the AbioCor patient. The
EMTs will be trained on what procedures can be performed such as
respiratory support and those that should be avoided such as the use of
a defibrillator.

##  Equipment Requirements

The following AbioCor equipment should be provided to the patient at
time of discharge.

(1) One console and two ten-foot TET coils (one for car one for home)

(2) Two radio frequency transceivers

(3) Two PCE TET drivers / battery bag

(4) Eight external battery packs

(5) Two external battery chargers

(6) Two AC/DC adapters for the PCE drivers

(7) A two month supply of Duoderm patches for the TET

(8) Two hand held alarm monitors

(9) Reference documents as needed

##  Patient requirements for discharge

+------------------+---------------------------------------------------+
| **System**       | **Patient Status**                                |
+------------------+---------------------------------------------------+
| Neurological     | Intact                                            |
+------------------+---------------------------------------------------+
| Cardiovascular   | Hemodynamically stable                            |
+------------------+---------------------------------------------------+
| Respiratory      | Adequate oxygenation and perfusion                |
|                  |                                                   |
|                  | (home O~2~ is acceptable)                         |
+------------------+---------------------------------------------------+
| GI - GU          | -   Good appetite                                 |
|                  |                                                   |
|                  | -   Active bowel                                  |
|                  |                                                   |
|                  | -   No active GI bleeding                         |
|                  |                                                   |
|                  | -   Adequate nutritional intake                   |
+------------------+---------------------------------------------------+
| Infection        | No signs/symptoms of active infection             |
|                  |                                                   |
|                  | (or on antibiotic infusions administered by home  |
|                  | health)                                           |
+------------------+---------------------------------------------------+
| Activity         | Independent (or with minimal assistance) with     |
|                  | home cardiovascular exercise program              |
+------------------+---------------------------------------------------+
| Pain Management  | Pain controlled with minimal analgesics           |
+------------------+---------------------------------------------------+
| Wound Management | Wounds free of visible sign of infection.         |
+------------------+---------------------------------------------------+
| Education        | -   Plan of care                                  |
|                  |                                                   |
|                  | -   AbioCor operation                             |
|                  |                                                   |
|                  | -   Medication                                    |
|                  |                                                   |
|                  | -   Emergency contacts                            |
+------------------+---------------------------------------------------+
| Data Management  | Data connection with ABIOMED                      |
+------------------+---------------------------------------------------+

##  Steps for Discharge to Intermediate Care Facility

+----------+-------------------------------------+---------------------+
| Step \#  | Requirement                         | Evaluation Criteria |
+==========+=====================================+=====================+
| 1        | Patient or caregiver demonstrates   | Demonstration will  |
|          | proficiency in operating and        | be evaluated based  |
|          | troubleshooting the AbioCor and     | on written and oral |
|          | shows understanding of how to       | testing             |
|          | respond to emergencies.             |                     |
+----------+-------------------------------------+---------------------+
| 2        | Supervised\* day trips to           | Upon returning from |
|          | intermediate care facility without  | this trip, the      |
|          | overnight stay.                     | patient will be     |
|          |                                     | evaluated to assess |
|          | \*(with assistance of hospital      | compliance with     |
|          | staff)                              |                     |
|          |                                     | -   medication      |
|          |                                     |                     |
|          |                                     | -   care plan       |
|          |                                     |                     |
|          |                                     | -   ability to care |
|          |                                     |     for self        |
|          |                                     |                     |
|          |                                     | -   device          |
|          |                                     |     operation.      |
+----------+-------------------------------------+---------------------+
| 3        | Independent\* day trips to          | Upon returning from |
|          | intermediate care facility without  | this trip, the      |
|          | overnight stay.                     | patient will be     |
|          |                                     | evaluated to assess |
|          | \*(without assistance of hospital   | compliance with     |
|          | staff)                              |                     |
|          |                                     | -   medication      |
|          |                                     |                     |
|          |                                     | -   care plan       |
|          |                                     |                     |
|          |                                     | -   ability to care |
|          |                                     |     for self        |
|          |                                     |                     |
|          |                                     | device operation    |
+----------+-------------------------------------+---------------------+
| 4        | The patient may be released to the  | Consensus of the    |
|          | Intermediate care facility for a    | patient, the        |
|          | period sufficient to base an        | family, the         |
|          | evaluation on (most likely 1-3      | clinical team.      |
|          | days) with overnight stays.         |                     |
|          |                                     |                     |
|          | Patient will make return visits to  |                     |
|          | the hospital as defined in the      |                     |
|          | schedule.\*                         |                     |
|          |                                     |                     |
|          | \*Schedule to be outlined by        |                     |
|          | clinical team.                      |                     |
+----------+-------------------------------------+---------------------+

##  {#section-16 .unnumbered}

##  {#section-17 .unnumbered}

##  Steps for discharge to home

Discharge steps to home will follow the same basic outline provided for
in the discharge steps to intermediate care facility.

Staffing coverage Intermediate Care Facility

The patient will be accompanied at all times by appropriate qualified
personnel. Appropriate qualified personnel could include:

-   Family members or friends who have been trained by the clinical team
    in the use of the AbioCor system.

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-   Trained RNs, LPNs, or Home Health Aide provided thru the clinical
    center, or local agency.

The Clinical Center will make available personnel, in person or by
phone, in the event of an emergency.

Caregiver Availability at home

A qualified caregiver will be with the patient at all times.

Education of AbioCor implanted patients, family, and caregivers

Training for the patient and any individuals who may assist the patient
will consist of information on how to care for and monitor the AbioCor,
as well as how to respond to alarms and emergency situation.

Outline of topics to be covered:

-   System overview

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-   Responding to alarms

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-   Adjustments of beat rate, and balance settings

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-   Removing external TET and care of TET area

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-   Maintaining proper Radio Frequency (RF) communications

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-   Using AbioCor Consol in home screen mode

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-   Use of Patient Carried Electronics (PCE)

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-   Use of the Hand Held Alarm Monitor

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-   Emergency procedures

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-   Medications

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-   Nutrition

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-   Exercise and activity parameters

**Notification of utilities**

Local Power Company will be notified of the fact that there is a
customer that requires power for life support equipment.

**Notification of Emergency Medical Services**

The agency responsible for responding to 911 calls for emergency medical
assistance should be notified.

**Contact information**

Each AbioCor patient will be provided with a contact list including the
following numbers. See attached sample

-   Hospital coordinator

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-   ABIOMED

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-   Physician

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-   Emergency assistance (911)

**Plan of Care**

Each AbioCor patient will be given a plan of care designed for that
patient. The plan will be review with the patient and the family by the
clinical team. With each office visit progress will be compared with the
plan, and the plan will be modified as needed.

**AbioCor Log sheet**

The patient or their caregiver will fill out the AbioCor flow sheet at a
minimum of two times a day.

**Medication log**

A log listing all of the AbioCor patient's medication will be reviewed
with the patient and caregivers. The log will include the following:

-   Medication Name

-   Dosage information

-   Indication

**Appointment calendar**

The coordinator will develop a calendar listing regularly scheduled
appointments.

See attached sample calendar.

**Journal**

AbioCor patients will be encouraged to keep a journal where they can
make notes regarding any problems with the implants or external
equipment. They will also be encouraged to make notes about their
overall health or any other issues they may be feeling.

**Equipment log**

An inventory of all AbioCor external equipment will be maintained. In
the event of a recall the hospital coordinator will be contacted. See
attached sample.

**Hospital maintained Records**

-   Patient demographics

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-   List of consults

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-   Equipment logs

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-   Medication logs

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-   Laboratory blood work tracking sheet.

**Patient ID card**

![](media/image8.png){width="6.24375in" height="2.46875in"}

# 10 Outline of Clinician training Program {#outline-of-clinician-training-program .unnumbered}

Training on implanting, patient care of the AbioCor will involve all
members of the clinical team. Depending on the individual's, involvement
their training may include; classroom / demonstration training, and / or
animal lab training.

Clinical centers are expected to designate critical members of the
AbioCor implant teams before AbioCor training can begin. Team members
should include at least the following personnel:

**Surgical Team:** (minimum)

2 surgeons

First assistants

Scrub nurse

Circulating nurse

Perfusionist

Anesthesiologist

Device operator

> **Recovery team:**

4 to 5 ICU recover nurses.

The AbioCor training program will consist of a minimum of two animal
implant sessions combined with classroom instruction. The organization
and timing of these training sessions will be arranged on center by
center bases, but re expect the program to follow the following format.

## Introductory Class room session and workshop 

The ABIOMED team will travel to the implant facility to conduct a one
day seminar and workshop on the basics of the AbioCor operation. The
morning session will be spent reviewing the system architecture, theory
of operation, system software and control algorithms, and AbioCor
external console user interface. The afternoon session will be hands on
session that will allow participants the opportunity to get acquainted
with the system components, including the opportunity to operate the
system with a mock circulatory loop. It is expected that all members of
the surgical team and the primary post-operative care team participate
in this training.

## Pre-Animal Lab training

As preparation for the first animal lab, the AbioCor training team will
conduct a pre-lab training workshop. This workshop will consist of a
presentation of the basic steps to implantation, followed by a mock
implant using the system components, interactive video, and the
mock-circulatory loop. Members of the implant team are expected to
participate in this training.

## Animal Lab / Peer Visit

Members of the Implant team will travel to an AbioCor Training center
where they will have the opportunity to train under the direction of
your experienced counter parts in an experienced AbioCor center. The
objectives of these labs are as follows:

a.  Members of the implant team will complete the AbioCor pre-implant
    system check-out.

b.  Members of the implant team will complete the steps for implantation
    as described in the Implanting the AbioCor IFU.

c.  Surgical / Perfusion / and device operators will become proficient
    with de-airing the AbioCor and transitioning from by-pass to AbioCor
    support.

d.  Surgical teams will demonstrate the procedure for transitioning from
    Console control and power to the implanted system.

After the animal lab we will arrange for the opportunity for you to meet
with members of the Training Center's AbioCor team. This will be an
informal gathering of doctors from all disciplines, nurses from both the
recover and step-down units, and VAD coordinators. This will give you
the opportunity to exchange ideas, and hear what worked and did not
work, and ask questions.

## Subsequent Animal Labs

Additional training labs will be conducted at your own center's animal
facility if available or at the AbioCor training center. This will give
the opportunity for extended team participation. A video tape will be
available for review prior to the animal lab. The same objectives,
participation requirements and follow up will be a part of these labs.

Full participation in each element of the training sessions is required.
In order for the clinical center to be considered ready to conduct
implants, full and consistent attendance is required by the surgical
team for all the training implants

## Post-operative care team training

Members of the post-operative care team will participate in the initial
introduction to AbioCor training session. In addition, Members of the
AbioCor training team will provide class room and hands on training
sessions that are specifically designed to meet the needs of the team.
Topics covered will include:

e.  Review of AbioCor implanted and external components

f.  Pre-implant patient considerations

g.  Post-operative monitoring and target hemodynamic ranges

h.  Post-operative care

i.  Device management

## Step-down unit training

When the time comes to transfer the AbioCor patient from the ICU to the
step-down unit, we have found that the best trainers are the now
experienced AbioCor recovery team members at the center. ICU nurses will
cross train the nurses from the Step-down unit. The ABIOMED AbioCor
Clinical Team will be available to provide basic system overview
training and support as needed.

## Criteria for Clinical Readiness from Training Sessions

1 Successful completion of two animal implantations.

Normal Post-implant hemodynamics must be demonstrated

Demonstration of understanding of system electrical connections

Demonstration of De-airing techniques

1.  System Operator must demonstrate proficiency and knowledge by using
    the

training loop.

3.  Post-op team must understand device/physiologic interaction and
    patient

management.

4 Clinical team must be familiar with patient selection criteria.

#  System components

##  Implantable Kit

## Console Kit

  ------ ------------------------------------------ -------------------- -----
  Item                                              Part \#              Qty

         AbioCor Console                            0034-4430            1

         Power Cord                                 6000-0025            1

         Console case                               0034-4400            1

         RF Comm Module                             0034-4458-HD         2

         11\' External TET packaged                 0034-4660            1

         Console Alarms User\'s Guide               0034-0980-00020      1
  ------ ------------------------------------------ -------------------- -----

## PCE and Home Kit

##  {#section-18 .unnumbered}

#  Materials Matrix

The AbioCor and the AbioCor sub components are manufactured from raw
materials. The following Matrix lists all materials which come in
contact with tissue.

## Thoracic Unit

  ----------------------------------- -----------------------------------
  Component                           Material

  Energy Converter, Exterior Metal    Titanium

  Exterior Blood Pump Area            Epoxy

  Interior of Blood Pump              AngioFlex (Polyetherurethane)

  Cable outer insulation              Carbothane

  Cuffs                               Velour

  Grafts                              Dacron
  ----------------------------------- -----------------------------------

## Implantable Battery and Controller

  ----------------------------------- -----------------------------------
  Component                           Material

  Enclosure                           Titanium
  ----------------------------------- -----------------------------------

## Implantable TET

  ----------------------------------- -----------------------------------
  Component                           Material

  Outer Covering                      AngioFlex (Polyetherurethane)

  Cable out insulation                Carbothane

  Connector                           Titanium
  ----------------------------------- -----------------------------------

## External TET

  ----------------------------------- -----------------------------------
  Component                           Material

  External Surface (cable and Coil    Silicone
  Covering)                           
  ----------------------------------- -----------------------------------