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General| Pump Type | Centrifugal |
|---|---|
| Implantation Site | Pericardial space |
| Flow Rate | Up to 10 L/min |
| Device Type | Left Ventricular Assist Device |
| Manufacturer | Medtronic |
| Intended Use | Bridge-to-transplant for patients with advanced heart failure |
| Thickness/Length | 25 mm |
| Power Consumption | Approximately 6 watts |
| Drive Line | Percutaneous |
| Power Source | External batteries or AC power |
| Controller | External wearable controller |
| FDA Approval | Yes |
Explains the purpose and importance of reading the patient manual for proper system use.
Provides a basic understanding of heart failure and its symptoms.
Discusses Ventricular Assist Devices (VADs) as a treatment option for severe heart failure.
Details the surgical implantation and basic operation of the HeartWare HVAD system.
Lists potential adverse events and risks associated with the HVAD system implantation and use.
Outlines the advantages and expected improvements from using the HeartWare HVAD system.
Guides patients and clinicians in determining the suitability of the HVAD system as a treatment.
Presents findings from clinical studies evaluating the HeartWare HVAD system's efficacy and safety.
Describes and illustrates the key components of the HeartWare HVAD system.
Details critical safety information, warnings, and precautions for handling the HVAD system.
Briefly describes the expected functional performance of the HVAD pump.
Explains the surgical procedure for implanting the HeartWare HVAD system.
Explains the function, display, buttons, and connections of the HVAD system controller.
Provides instructions on connecting and disconnecting the driveline and power sources.
Details the steps for connecting and disconnecting the patient driveline to the controller.
Outlines the procedure for connecting and disconnecting the controller's power sources.
Guides users on how to safely switch between different power sources for the controller.
Explains how to check battery status and manage battery power for the system.
Provides instructions on replacing the system's batteries safely and effectively.
Details how to set up and use the battery charger to charge system batteries.
Guides users on how to properly pack and use the various carrying cases for the HVAD system.
Provides information on the expected lifespan and replacement guidelines for HVAD system components.
Outlines procedures for responding to emergencies and contacting appropriate medical help.
Explains the different types of alarms (high, medium, low) and their indicators.
Describes the [No Power] alarm, its cause, and the immediate actions required.
Details high priority alarms that require immediate attention and action.
Explains medium priority alarms and the necessary steps to take.
Describes low priority alarms and the recommended actions to resolve them.
Addresses situations where multiple alarms occur simultaneously and how to manage them.
Explains how to silence medium and low priority alarms temporarily.
Provides step-by-step instructions for safely exchanging the primary controller with a backup.
Lists essential equipment and accessories required for patients upon hospital discharge.
Covers critical instructions for daily care, equipment maintenance, and lifestyle adjustments post-discharge.
Presents training exercises and questions to ensure patient and caregiver understanding of the system.
Discusses the importance of understanding and adhering to prescribed medications, especially anticoagulants.
Explains Electrostatic Discharge (ESD) and how to prevent it from damaging system components.
Details the proper procedures for caring for the driveline exit site to prevent infection.
Provides guidance on personal hygiene, including safe showering practices with the HVAD system.
Instructs users on how to properly pack the controller and batteries into the shower bag.
Offers advice and requirements for safely traveling with the HeartWare HVAD system.
Outlines basic cleaning and handling procedures for the HVAD system equipment.
Provides specific instructions for inspecting and maintaining the HVAD system controller.
Details best practices for battery storage, usage, and maintenance to ensure optimal performance.
Explains how to inspect, clean, and maintain the HVAD system's battery charger.
Provides instructions on cleaning and maintaining the system's carrying cases and shower bag.
Defines key terms and acronyms used throughout the HeartWare HVAD system manual.
Provides the correct answers to the training exercises found in the Appendix section.
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