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General| Brand | HeartWare |
|---|---|
| Model | HVAD Pump |
| Category | Health Care Products |
| Language | English |
Overview of the HeartWare™ HVAD™ System and patient indications for use.
Lists conditions where the system should not be used and critical safety warnings.
Provides cautionary advice and lists potential adverse events associated with the VAD.
Details key clinical studies evaluating the system's safety and effectiveness.
Describes the HVAD® Pump components and necessary surgical tools for implantation.
Explains the function and features of the HVAD® Controller and HeartWare® Monitor.
Details controller power sources, battery charger, and battery usage.
Covers the use of carrying cases and the shower bag for system components.
Explains how the HVAD® Pump works and its blood flow characteristics.
Details control algorithms for device performance and blood flow estimation.
Provides operating guidelines and requirements for pump tracking and reporting.
Explains controller connections, power sources, and disconnection procedures.
Details controller display, buttons, indicators, and settings menu.
Guides on using, charging, caring for, and understanding battery indicators.
Explains setup and use of the battery charger and AC/DC adapters.
Covers carrying cases, shower bag, and recommended equipment for home use.
Provides an overview of the monitor, its power, and screen layout with icons.
Details clinical, alarm, trend, and system screens for operation and settings.
Guides on updating software and maintaining the monitor's cleanliness and battery.
Covers necessary equipment and preparation steps before HVAD® Pump implantation.
Details the procedure for programming both primary and back-up controllers.
Describes pre-implant testing and assembly procedures for the HVAD® Pump.
Outlines the step-by-step surgical procedure for implanting the HVAD® Pump.
Details procedures for explanting the HVAD® Pump for transplant or recovery.
Covers critical patient care aspects post-implantation: BP, anticoagulation, RHF.
Provides guidelines for driveline care, exit site dressing, and infection prevention.
Outlines emergency procedures and recommendations for physical rehabilitation.
Emphasizes patient training for system operation, alarms, and emergency response.
Introduces the alarm system, classification, and indicators for high, medium, and low priority.
Details the highest priority alarms, their messages, and potential causes.
Describes medium and low priority alarms, their meanings, and recommended actions.
Explains how the system handles multiple alarms and how to silence them.
Guides users through the procedure for safely changing the controller.
Quick reference for critical alarms: symbols, tones, display, causes, and actions.
Quick reference for medium alarms: symbols, tones, display, causes, and actions.
Quick reference for low alarms: symbols, tones, display, causes, and actions.
Lists all system components, categorized by implantables, tools, and externals.
Provides detailed technical specifications for all system components.
Outlines electromagnetic compatibility requirements and guidance for the system.
Defines various symbols used throughout the manual for clarity and compliance.
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