To Next PageTo Next PageWhat to do if the Thoratec HEARTMATE II Medical Equipment shows a Pump Off Alarm?
If the Thoratec Medical Equipment pump has stopped, possibly due to a disconnection or power failure, immediately connect to a power source. If this doesn't solve the issue, press any button on the System Controller to attempt to restart the pump, and then immediately contact your hospital for further instructions.
What to do if Thoratec HEARTMATE II Medical Equipment shows a 'No External Power Alarm'?
If the Thoratec Medical Equipment displays a 'No External Power Alarm', it means the System Controller isn't getting power from the power cables and is running on its backup battery. Immediately connect to a functioning Power Module, Mobile Power Unit, or two fully-charged HeartMate 14 Volt Lithium-Ion batteries to keep the pump running.
General| Brand | Thoratec |
|---|---|
| Model | HEARTMATE II |
| Category | Medical Equipment |
| Language | English |
Explains the meaning and format of warnings and cautions in the manual to ensure safe system operation.
Describes the HeartMate II system, its components, and how it functions to support the left ventricle.
Details the approved uses of the HeartMate II LVAS for patients with end-stage left ventricular failure.
Identifies patients for whom the HeartMate II LVAS is not recommended due to contraindications.
Lists potential adverse events associated with the use of the HeartMate II LVAS, ordered by frequency.
Outlines the necessary understanding, training, and prerequisites for using the HeartMate II LVAS.
Introduces the main parts of the HeartMate II system and useful accessories, with brief descriptions.
Lists components and equipment required, backup, and optional for implantation and ICU transfer.
Explains how the HeartMate II LVAD generates flow based on pump speed and differential pressure.
Explains parameters like Speed, Power, Flow, and Pulsatility Index (PI) that are monitored during system operation.
Provides an overview of the HeartMate II LVAD, its axial flow rotary pump, and its connection to the native circulation.
Describes the System Controller as a computer that controls and monitors system operation, sending signals to the LVAD.
Explains the purpose and handling of the backup System Controller, which is identical to the running one.
Describes the system's power sources: Power Module, Mobile Power Unit, and HeartMate 14 Volt Lithium-Ion batteries.
Explains the function of the Power Module for clinical use and its required components for connection.
Describes the Mobile Power Unit's function for home or clinical use when the patient is stationary or sleeping.
Explains how to use battery power for greater patient mobility and the components required for operation.
Provides instructions on how to switch between the Power Module, Mobile Power Unit, and battery power sources.
Describes the Battery Charger's design for charging, calibrating, and testing HeartMate 14 Volt Lithium-Ion batteries.
Explains the System Monitor's role in displaying system performance and allowing parameter/setting changes.
Details the steps for setting up the System Monitor for use with the Power Module.
Describes the touch-screen interface, accessible screens, and communication icon for the System Monitor.
Describes the Clinical screen, the default display showing primary operating parameters and command buttons.
Used to monitor parameters, change speed settings, and manually stop the pump, displaying system status and alarms.
Shows the status of all Hazard and Advisory alarms, including messages, parameters, and command buttons.
Describes preimplant, implant, and explant procedures for the HeartMate II LVAS, including important warnings.
Lists sterile and additional equipment and supplies required for the HeartMate II LVAS implant procedure.
Details preimplant procedures, including warnings and cautions for handling components and preparing the surgical field.
Illustrates the proper orientation of the LVAD and describes the implantation configuration.
Describes procedures to follow after implantation, including patient transfer, backup system programming, and monitoring.
Details the process for explanting the Left Ventricular Assist Device, including warnings and required equipment.
Provides essential warnings and considerations for proper postoperative care of patients supported by the HeartMate II LVAS.
Covers patient assessment, including pump function, vital signs, and potential risks like hypovolemia and infection.
Discusses considerations for MRI, external chest compressions, and right heart failure in HeartMate II patients.
Explains how to use the Shower Bag to protect system components from water during showering.
Details how to use the HeartMate Stabilization Belt to immobilize the driveline and reduce exit site trauma.
Describes various wearable accessories for comfortably and securely holding or carrying system components.
Provides instructions for patients on connecting to power modules and immobilizing the driveline before sleeping.
Emphasizes driveline protection from damage and outlines guidelines for its care and inspection.
Lists essential topics for training patients, families, and caregivers on system operation, care, and emergency response.
Details patient-resolvable vs. clinician-resolvable alarms, their display locations, and common causes.
Lists Power Module alarm conditions, their visual and audio indicators, and recommended responses.
Describes Mobile Power Unit alarms, including illuminated symbols and sounds, and how to resolve them.
Details battery-related and charger-related advisory messages on the Battery Charger display panel.
Provides instructions on correctly connecting and disconnecting power cable connectors to avoid damage.
Highlights actions to avoid with driveline and cables to prevent damage and ensure system function.
Outlines acceptable environmental conditions for packaged storage and transport of system components.
Provides guidelines for cleaning and maintaining system components, including the System Controller, power cables, and driveline.
Details specific product disposal considerations for various HeartMate equipment and batteries according to regulations.
Summarizes the primary objective, design, and patient population of the HeartMate II BTT Primary Study Cohort.
Details the objective, design, and patient population of the HeartMate II LVAS as a destination therapy device.
Describes the Post-Approval Study (PAS) conducted to assess the commercial use of HeartMate II as a BTT indication.
Presents the incidence of serious adverse events observed in the HeartMate II LVAS study by cohort and event type.
Lists dimensions, volumes, blood contacting surfaces, construction, and performance data for the implant kit.
Details active functions, operating modes, monitoring functions, alarm sound pressure levels, dimensions, weight, and product life.
Provides performance data, dimensions, weight, and product life for the 11 Volt Lithium-Ion backup battery.
Lists active functions, monitoring functions, alarm SPL, power requirements, fuse rating, dimensions, weight, and product life.
Describes the type, function, length, and product life of the Power Module patient cable.
Provides active functions, monitoring functions, alarm SPL, power requirements, dimensions, cable length, weight, and product life.
Lists performance data, dimensions, weight, and product life for the HeartMate 14 Volt Lithium-Ion batteries.
Provides dimensions and product life for the 14 Volt Lithium-Ion Battery Clip.
Details the components, function, compatibility, strength, color, size, and product life of the Wearable Accessories Kit.
Describes the type, function, compatibility, strength, color, sizes, and product life of the Stabilization Belt.
Provides type, function, compatibility, strength, color, size, and product life for the Travel Bag.
Lists safety standards and declarations for the HeartMate II LVAS, including UL, IEC, EN, and CAN/CSA standards.
Details compliance with safety standards and guidance for electromagnetic emissions for the HeartMate Power Module.
Details compliance with safety standards and guidance for electromagnetic emissions for the Mobile Power Unit.
Lists safety standards and guidance for electromagnetic emissions for the Battery Charger.
Details compliance with safety standards and guidance for electromagnetic emissions for the HeartMate 14 Volt Lithium-Ion Batteries.
Provides descriptions for general symbols found on HeartMate II components, accessories, and packaging.
Describes symbols related to charging and product use dates for 14 Volt Lithium-Ion batteries.
Describes symbols related to backup battery use by date.
Refers to symbols on the System Controller user interface for operational status and information.
Refers to symbols on the Mobile Power Unit user interface for operational status and alarms.
Describes symbols for Monitor, Power ON/OFF, Fuse Rating, Direct Current, Rechargeable Battery, and Battery Check.
Describes symbols for Power OFF, Power ON, and Input connections on the System Monitor.
Provides a checklist of daily tasks to ensure the proper operation and safety of the HeartMate II system components.
Lists checks for electrical connections, power sources, System Controller placement, and bedside items before sleep.
Details weekly inspections of equipment, cables, batteries, charger, and accessories for damage or wear.
Includes reviewing alarms, checking battery expiration dates, and verifying manufacture dates of batteries.
Covers backup System Controller maintenance and patient skill evaluation for core tasks.
Focuses on scheduled inspection and cleaning of Power Module and Battery Charger by trained personnel.
Covers cleaning exit sites, batteries, and the Battery Charger as needed, and replacing worn equipment.
Guides checks on system operation, emergency handling, and patient/caregiver demonstration of core skills.
Discusses training needs, differences in alarm presentation, and the 'feel' of connections for patients converting to the Pocket System Controller.
Lists abbreviations used in the HeartMate II Left Ventricular Assist System manual and their meanings.
Provides definitions for key terms and concepts related to the HeartMate II Left Ventricular Assist System.
