Introduction; Indications And Contraindications For Use; Warnings - HeartWare Ventricular Assist System Instructions For Use Manual

Foreword
The HeartWare ® Ventricular Assist System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. Clinical users
include physicians, registered nurses, perfusionists and biomedical engineers. Implant of the device must be performed by a qualified cardiac surgeon trained by HeartWare-authorized
personnel. Clinical users of the HeartWare
(LVADs), and should be aware of the physical and psychological needs of patients undergoing LVAD support. Patients and caregivers should complete a user training program and
demonstrate their ability to use the system. Clinicians should read the entire Instructions for Use before system operation. This manual may serve as a reference for detailed information
including specific information on device function, system setup, implant and maintenance. This manual is not intended to replace comprehensive educational programs or to supersede
acquired knowledge or proper medical judgment.

1.0 INTRODUCTION

warning: Carefully read this entire manual prior to implanting or operating the device.
The HeartWare Ventricular Assist System (HeartWare
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ventricle. The HeartWare System utilizes a centrifugal blood pump, the HVAD
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in the pericardial space with left ventricular apex to ascending aortic cannulation for left ventricular support (Figure 1).
The inflow conduit, which is partially sintered, is integrated with the pump and a 10mm gel impregnated outflow graft
with a strain relief is attached to the pump. A percutaneous driveline connects the pump to an external controller. The
controller, powered by two batteries or by one battery and electricity from the wall or car outlet, regulates pump function
and monitors the system. The monitor is used to display system performance and to change controller operating
parameters. A battery charger is also included.
All components of the HeartWare System were designed to be used only in conjunction with each other. They are not
compatible or intended to be used with other manufacturer's devices.

2.0 INDICATIONS AND CONTRAINDICATIONS FOR USE

The HeartWare HVAD System is intended for use in patients at risk of death from refractory end-stage heart failure. The HeartWare
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◗ ◗
hospital settings, including transportation via fixed wing aircraft or helicopter.
The HeartWare System is contraindicated:
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◗ ◗
– In patients with a body surface area (BSA) less than 1.2 m²
– In patients who cannot tolerate anticoagulation therapy
– During pregnancy

3.0 WARNINGS

This Instruction for Use is intended to be used by physicians, nurses, and other clinical professionals. Setup and operation of this device should only be
1)
undertaken by personnel who have completed HeartWare's setup and operation training. A thorough understanding of technical principles, clinical
applications and risks associated with the HeartWare
and risks may result in improper operation of the system and potential harm to the patient or to the user.
Carefully read this entire manual prior to implanting or operating the device.
2)
3) The HeartWare ® System has only been evaluated in patients greater than or equal to 18 years of age. Consider other methods of mechanical circulatory support for patients younger
than 18 years.
The HVAD Pump should not be implanted in patients with a known nickel allergy.
4) ®
5) Gel impregnated polyester vascular prostheses should not be implanted in patients who exhibit sensitivity to polyester or materials of bovine origin.
The HVAD Pump may cause interference with AICDs. If electromagnetic interference occurs, it may lead to inappropriate shocks, arrhythmia and possibly death. The occurrence of
6) ®
electromagnetic interference with AICD sensing may require adjustment of lead sensitivity, proximal placement of new leads or replacement of an existing sensing lead.
7) Use only HeartWare-supplied components with the HeartWare
Disconnecting both power sources (batteries and AC or DC adapter) at the same time will stop the pump. At least one power source must be connected at all times.
8)
Keep a spare controller and fully charged batteries available at all times in case of an emergency.
9)
10) Sterile components are intended for single use only. DO NOT use if package is damaged or opened. DO NOT re-sterilize or re-use.
During the Pre-Implant Test and prior to implantation: The HVAD
11)
an HVAD ® Pump that was turned on without total submersion in fluid.
12) Rotate the graft clamp so that the clamp screw is located on the inner side of the outflow graft to avoid tissue irritation or damage.
DO NOT use excessive force when tightening the clamp screw because this could damage the graft clamp or graft clamp screw. Replace components if required.
13)
14) DO NOT loosen the sewing ring's screw by turning the screw counterclockwise or it may fall off the sewing ring.
To remove the driveline cap from the driveline, unscrew the outer sleeve, then pull back on the grooved part of the connector. DO NOT grasp the driveline and pull because this may damage
15)
the driveline.
16) An audible click should be heard when connecting the driveline to the controller or driveline extension. Failure to ensure a secure connection may cause an electrical fault.
To remove the driveline from the controller, first pull back the driveline cover then grasp and pull the driveline connector. DO NOT grasp the driveline cable as this may damage the driveline.
17)
All air must be removed from the HVAD
18)
19) In order to minimize the risk of air embolus during implant, keep both power supplies connected to the controller after setting up the primary controller. Disconnecting and then reconnecting
both power supplies will result in the controller starting the pump as soon as the driveline is connected.
20) HVAD ® Pump flow estimation may not be accurate during the de-airing procedure.
21) A controller with a blank display or no audible alarm should be replaced.
Silencing an alarm does not resolve the alarm condition. ALWAYS investigate, and if possible, correct the cause of any alarm.
22)
System should attend HeartWare clinical operator training, should have a working knowledge of the principles of left ventricular assist devices
®
System) is designed to assist a weakened, poorly functioning left
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System is required before using this product. Failure to understand these principles, applications
®
® System.
Pump must be completely submerged in fluid before being turned on. Never turn on the HVAD
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Pump and its conduits to reduce risk of air embolus.
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Ventricular Assist System
Pump (the "pump"), which is implanted
Figure 1: HeartWare Ventricular Assist System
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1. Monitor 4. Controller
2. HVAD Pump 5. Battery
3. AC Adapter
System is designed for in-hospital and out-of-
®
Pump in air. DO NOT use
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Instructions For Use
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