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L E F T V E N T R I C U L A R A S S I S T D E V I C E ( L V A D ) P A T I E N T G U I D E VIVIAN HeartMate 3 LVAD ™ Recipient...
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Q U I C K S TA R T G U I D E his patient guide is for using the HeartMate 3™ Left Ventricular Assist Device (LVAD) that both the patient and caregiver will need to be familiar with upon hospital discharge. Although most of the procedures can be performed by the patient, a caregiver’s assistance will be needed...
TA B L E O F C O N T E N T S The HeartMate 3™ LVAD System ............ 5 What Should I Know Prior to Hospital Discharge? ..... 6 SYSTEM CONTROLLER Overview ....................9 Buttons and User Interface Screen ..........10 User Interface Screen Display ............
Powers and checks the pump and driveline. Provides power to the System Controller and The controller uses alerts to tell you how the pump. Echoes System Controller alarms. system is working and includes 15 minutes of emergency backup power. The HeartMate 3™ LVAD System |...
• How to change to the backup System Controller (in case of an emergency) IMPORTANT: Be sure to keep a backup System Controller and charged batteries with you at all times for use in case of an emergency. | The HeartMate 3™ LVAD System...
SYSTEM CONTROLLER: OVERVIEW 1. POWER SOURCE CONNECTIONS The System Controller is a small computer that controls and checks system information. 2. DRIVELINE CONNECTION It is connected to the pump via the driveline. It is used to control and respond to system 3.
SYSTEM CONTROLLER: BUTTONS AND USER INTERFACE SCREEN 1. BAT TERY BUTTON 3. SILENCE AL ARM BUT TON • Displays the battery power • Silences an active alarm (press and release). (press and release). • Displays previous alarms (press and • Tests the controller (press and hold release the silence alarm and display for 5 seconds).
SYSTEM CONTROLLER: USER INTERFACE SCREEN DISPL AY DISPLAY BUTTON SCREEN DISPLAYED ACTIONS (EXAMPLE) MEANING Press ONCE Pump speed in revolutions per minute Press SECOND time Pump flow in liters per minute Press THIRD time Pulsatility index Press FOURTH time Power in watts Press FIFTH time The System Controller’s backup battery (located inside the System Controller and used to temporarily...
SYSTEM CONTROLLER: LIGHTED SYMBOLS The System Controller provides information about the system’s functioning using lighted symbols on the device. The symbols indicate when the pump is running or when there’s a problem with the pump’s functioning that needs immediate attention. Other symbols indicate remaining battery power, problems with the connections to the power cable or driveline, or other issues with the system.
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SYSTEM CONTROLLER: LIGHTED SYMBOLS PUMP RUNNING LIGHT Stays lit green as long as the LVAD is running. BATTERY CAPACITY LIGHT 4 green lights = Approximately 75%–100% of power remains 3 green lights = Approximately 50%–75% of power remains 2 green lights = Approximately 25%–50% of power remains 1 green light = Less than 25% of power remains Yellow diamond only = Less than 15 minutes of power remains LOW BATTERY ALERT...
Low battery, power 1. Promptly connect to a working or input is low, with different power source (MPU or two less than 15 minutes fully charged HeartMate 3 LVAD 14 V remaining lithium-ion batteries). 2. If alarm persists, call your hospital contact.
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SYSTEM CONTROLLER: AL ARMS ADVISORY SYSTEM CONTROLLER ACTIVE SCREEN SYMBOLS ALARM MEANS TO RESOLVE ALARM System Controller Call your hospital contact as soon as possible backup battery fault for diagnosis and instructions. System Controller Call your hospital contact as soon as possible backup battery for diagnosis and instructions.
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System Controller to attempt a pump start and call your hospital contact immediately. Pump has stopped 1. Immediately connect to HeartMate 3 LVAD running. MPU 14 V lithium-ion batteries. power has failed 2. If restoring power does not resolve, press any...
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Low voltage: Power 1. Immediately connect to a working power input is extremely source (MPU or two fully charged low, with less HeartMate 3 LVAD 14 V lithium-ion batteries). than 5 minutes 2. If alarm persists, call your hospital remaining. contact immediately.
SYSTEM CONTROLLER: CHANGES TO BACKUP SYSTEM CONTROLLER — MULTIPLE SOURCES multiple available Replace the running System Controller with the backup controller and power sources. 1. SET UP This procedure will require assistance 2. Ensure the patient is sitting or lying down, from a caregiver.
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SYSTEM CONTROLLER: CHANGES TO BACKUP SYSTEM CONTROLLER — MULTIPLE SOURCES Replace the running System Controller with the backup controller and multiple available power sources. 2. REPL ACE SYSTEM CONTROLLER Important: Keep the running System Controller 2. Promptly move the driveline from the connected to power.
SYSTEM CONTROLLER: CHANGES TO BACKUP SYSTEM CONTROLLER — SINGLE SOURCE single available Replace the running System Controller with the backup controller and a power source (exchange while on MPU or batteries only). 1. SET UP This procedure will require assistance from 2.
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SYSTEM CONTROLLER: CHANGES TO BACKUP SYSTEM CONTROLLER — SINGLE SOURCE Replace the running System Controller with the backup controller and a single available power source. 2. REPL ACE SYSTEM CONTROLLER 1. Move the white connector’s power source 3. Make sure that the green pump running from the running controller to the backup symbol on the backup controller is...
SYSTEM CONTROLLER: PERFORM A CONTROLLER SELF TEST Perform a System Controller self test every day 3. Release the battery button . All the audible indicators/lights should remain to check the audible and visual alarm indicators on for 15 seconds, after which the audible on the user interface.
SYSTEM CONTROLLER: DRIVELINE EXIT SITE CARE AND STABILIZATION It is very important to keep the driveline exit site center, should be used at all times. The driveline (where the driveline goes through the skin) clean management system should consist of a dressing and dry at all times.
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SYSTEM CONTROLLER: BACKUP BATTERY An 11 V lithium-ion backup battery inside the The System Controller’s backup battery will be System Controller provides at least 15 minutes charged once external power is connected of backup power to the LVAD if the in-use power to the System Controller (batteries or MPU).
Charge the backup battery inside the backup System Controller. 1. Connect the backup System Controller to a power source (MPU or two HeartMate 3™ LVAD 14 V lithium-ion batteries). 2. When the System Controller is connected to power, the user interface screen displays “Charging”...
14 V LITHIUM-ION BATTERIES The HeartMate 3™ LVAD uses 14 V lithium-ion batteries that provide up to 17 hours of support. They require 4 hours to charge. Five lights on each battery indicate the amount of power remaining in the battery.
POWERING THE SYSTEM: UNIVERSAL BATTERY CHARGER BATTERY CHARGER DISPL AY Slot number and LED indicators LED INDICATORS LED LIGHT COLOR STATUS/MEANING Green Battery is charged and ready for use. Yellow Battery is undergoing test, charging or calibration. Yellow blinking Battery requires calibration cycle (see the example on the next page). Battery or charging system is defective.
POWERING THE SYSTEM: BATTERY CHARGER DISPL AY MESSAGES MESSAGES GENERATED BY PRESSING THE SLOT NUMBER Available power Cycle count and charger capacity AUTOMATIC MESSAGES Call hospital for service For example, slot 4 Press 4 Calibration is in progress needs calibration for 12 hours Powering the System |...
MOBILE POWER UNIT (MPU) OVERVIEW 2. AC POWER RECEPTACLE The MPU plugs into an AC outlet to provide power to the HeartMate 3™ LVAD System and is used For plugging unit into AC power outlet. while indoors, stationary or sleeping. The MPU transfers power to the System Controller through 3.
POWERING THE SYSTEM: SWITCHING POWER SOURCES FROM MPU TO BATTERIES FROM BATTERIES TO MPU CONNECT Black to black White to white Powering the System |...
ALARM MEANS TO RESOLVE ALARM Internal fault 1. Promptly connect to two fully charged HeartMate 3™ LVAD 14 V lithium-ion batteries. 2. Call your hospital contact as soon as possible for diagnosis and instructions. Replace MPU batteries Replace the AA batteries in the MPU.
ACCESSORIES Shower Bag Keeps the controller and the batteries dry when you shower. Battery Holster Allows the batteries to be carried in shoulder straps. Consolidated Bag Belt Attachment Holster Vest Holds both the controller and the An alternative way of wearing A mesh vest that carries the batteries in one bag.
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Adverse Events: Adverse events that may be associated with the use of the HeartMate 3 Left Ventricular Assist System are: death, bleeding, cardiac arrhythmia, localized infection, right heart failure, respiratory failure, device...
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