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HeartWare HVAD System ™ ™ Patient Manual...
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Quick Reference Guide for Alarms When an alarm occurs, two lines of text appear in the Controller Display. The first line tells you what the alarm is, and the second line tells you what to do. The chart below shows all potential alarms you may see on your controller. Alarm Type Alarm Display (Line 1) Action (Line 2)
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All problems should be promptly reported to your clinician. Before you leave the hospital, add names and contact information below. It is very important to keep this information available in case something happens to you or to your HeartWare HVAD System.
1.6 Potential Benefits ......................5 1.7 How to Decide if the HeartWare HVAD System is the Right ™ ™ Treatment for You ......................5 1.8 Summary of Clinical Study Information Using the HeartWare HVAD System ..6 ™ ™ 2.0 HeartWare HVAD System Overview ™...
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5.1 Equipment Needed to Go Home ................56 5.2 Discharge Instructions ....................56 5.3 Patient and Caregiver Training (No Answers) ............59 The test with answers is located in the Appendix 6.0 Living with the HeartWare HVAD System ™ ™...
Understanding How the HeartWare HVAD System ™ ™ Works ......................Potential Complications and Risks ..........Potential Benefits ................... How to Decide if the HeartWare HVAD System is ™ ™ the Right Treatment for You ............Summary of Clinical Study Information Using the HeartWare HVAD System ........
™ care for the equipment and what to do in emergency situations. If you have any questions after reading this manual, please ask your clinician. WARNING! Please read this entire manual before using the HeartWare HVAD System outside of the ™...
The driveline is connected to the pump and exits the body through a small incision in the skin. The driveline connects to the controller. The controller is a mini computer that monitors the HVAD Pump. It provides text ®...
HVAD than with alternative treatment options. The overall rate of stroke was shown in randomized clinical trials to be higher with the HVAD than with alternative treatment options; however, one of the trials suggested that closely following a blood pressure treatment plan as recommended by your physician may reduce your stroke risk.
HVAD System is the Right ™ ™ Treatment for You Only you, in consultation with your clinicians can decide if having the HeartWare ™ HVAD System is right for you. Your clinicians will talk with you about the potential ™...
• Being alive on the HeartWare HVAD System for 180 days or ™ ™ • Receiving a heart transplant within 180 days of having the HVAD Pump implanted ® • Having the HVAD Pump successfully removed after the patient’s own heart ®...
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This study showed that implanting the HeartWare HVAD System ™...
Precautions ........Essential Performance ..............The Operation to Place the HeartWare HVAD ™ ™ System ......................WARNING! DO NOT use any components other than those supplied by HeartWare with the HeartWare HVAD System, as this may affect HeartWare HVAD ™ ™...
HeartWare HVAD System Overview ™ ™ Identifying the Components of the HeartWare HVAD System ™ ™ HVAD Pump and Driveline ® (Figure The HVAD Pump is small and has one moving part, called an impeller ® As the impeller spins it moves blood from the heart to the body. The amount of blood flowing through your pump depends on the speed of the impeller and your blood pressure.
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Each battery slides into a slot and the battery is connected to the battery charger. When not in use, you can safely leave the battery connected to the charger. Figure 9 For additional information on how the HeartWare Battery Charger works, see Section 3.6. ®...
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HeartWare HVAD System Overview ™ ™ Identifying the Components of the HeartWare HVAD System ™ ™ (continued) HeartWare Waist Pack ® The HeartWare Waist Pack is designed to hold the controller ® and two batteries around the waist. The waist pack comes with a support strap to help in putting on or taking off the pack, and a belt extender to make the waist pack belt bigger.
The risk of death as a result of stroke has been observed in randomized clinical trials to be higher with the HVAD than with alternative treatment options. The overall rate of stroke was shown in randomized clinical trials to be higher with the HVAD than with alternative treatment options;...
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DC adapter) at the same time since this will stop the pump and activate the [No Power] alarm. At least one power source must be connected at all times. 14. WARNING! DO NOT plug the HeartWare Battery Charger AC adapter into an ®...
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System components should not be used ™ ™ adjacent to or stacked with equipment other than specified in the Patient Manual. If adjacent to or stacked use is necessary, the HeartWare HVAD ™ ™ System and other equipment should be observed to verify normal operation.
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9. CAUTION: ALWAYS check to be sure the DC adapter works in your motor vehicle. The DC adapter is for use in motor vehicles only and may not fit all motor vehicles. 10. CAUTION: Use only HeartWare-supplied power adapters with the HeartWare ™...
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If this is not followed over consecutive charging cycles, the Battery Capacity Display will not function properly and may convey misleading battery capacity. 14. CAUTION: The HeartWare Waist Pack and the HeartWare Shoulder Pack ® ®...
23. CAUTION: DO NOT expose batteries to temperatures less than 0°C (+32°F) or greater than +50°C (+122°F) or the battery may run the pump for less time than usual. To preserve battery life, batteries should be stored at room temperature. 24. CAUTION: DO NOT attempt to repair or service HeartWare HVAD System ™...
HeartWare HVAD System. You ™ ™ will be trained on how to handle and care for your HeartWare HVAD System ™ ™ equipment, as well as how to respond to emergencies and alarms.
Making Connections ................ 3.2.1 Driveline Connection ............3.2.2 Power Source Connections ..........Changing Power Sources ............Using Battery Power ..............Changing Battery ................Battery Charger.................. Setting Up Your HeartWare HVAD System ™ ™ Carrying Cases ..................How Long HeartWare HVAD System Equipment ™...
The alarm adapter silences the [No Power] alarm and should only be attached to a controller that has failed or malfunctioned and is no longer connected to a pump. CAUTION: ALWAYS keep all connectors free of liquid, dust and dirt, or the HeartWare HVAD ™...
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HVAD Patient Manual ® How the Controller Works (continued) Table 2: Guide to Controller Display, Buttons, and Indicators (Refer to Figure 16) The CONTROLLER DISPLAY gives pump information including impeller speed (RPM), power (Watts), and blood flow (L/min). When an alarm occurs, the pump information is replaced by two lines of text that tell you what the alarm is and what to do.
Handling HeartWare HVAD System Components ™ ™ Making Connections 3.2.1 Driveline Connection Only disconnect your driveline if instructed to do so by the controller during an alarm or by your clinician. Anytime your driveline is not connected to the controller, your pump is not running.
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HVAD Patient Manual ® Making Connections (continued) 3.2.1 Driveline Connection (continued) To Connect the Driveline to the Controller: 1. Line up the red dots on the silver driveline connector and on the silver controller driveline port. Figure 20 2. Push the driveline connector straight into the silver port.
CAUTION: DO NOT force connectors together without proper alignment. Forcing together misaligned connectors may damage the connectors. CAUTION: ALWAYS keep all connectors free of liquid, dust and dirt, or the HeartWare HVAD ™...
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HVAD Patient Manual ® Making Connections (continued) 3.2.2 Power Source Connections (continued) Disconnecting Power Sources: 1. Turn the connector counterclockwise until it stops. Figure 26 2. Pull the connector straight out from the controller. NOTE: If another power source is not connected within 20 seconds, the [Power Disconnect] message will be displayed on the Controller Display and an alarm will sound.
CAUTION: ALWAYS check to be sure the DC adapter works in your motor vehicle. The DC adapter is for use in motor vehicles only and may not fit all motor vehicles. CAUTION: Use only HeartWare-supplied power adapters with the HeartWare HVAD System.
HVAD Patient Manual ® Using Battery Power It is important to understand how much charge a battery has before connecting to the controller. There are two ways to know if the battery is fully charged and ready for use: 1. The battery Test button 2.
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Handling HeartWare HVAD System Components ™ ™ Using Battery Power (continued) Battery Indicator 1 Alarm Indicator Active Battery Indicator Low Battery 1 Controller Display Replace Battery 1 Controller Display with a Low Battery Alarm Figure 30: When a depleted battery is not exchanged eventually, a high priority alarm will sound, the Alarm Indicator will be flashing RED and the message on the Controller Display will read [Critical Battery].
HVAD Patient Manual ® Changing Battery Make sure there is a fully charged battery available to replace the depleted battery. Disconnect the depleted battery, replace it with the fully charged battery and confirm it is securely attached. For information on how to connect and disconnect power sources, see Section 3.2.2.
Handling HeartWare HVAD System Components ™ ™ Battery Charger To Set up Your Battery Charger: 1. Insert the power cable into the back of the charger. Figure 31 2. Plug the other end of the cable into a wall outlet.
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HVAD Patient Manual ® Battery Charger (continued) 2. Place the battery into the slot. For the best fit, loop the cable gently to the side and place the battery with the cable-side down. Figure 35 3. Repeat steps 1 and 2 for all batteries. The charger can hold up to 4 batteries at one time.
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Defective battery. Do NOT use. Flashing Red Mark battery and return to Clinician. CAUTION: NEVER use other battery chargers to charge HeartWare Batteries. Other battery ® chargers may damage the batteries. CAUTION: ALWAYS wait until the "Ready" light turns on to disconnect the battery from the battery charger.
Setting Up Your HeartWare HVAD System Carrying Cases ™ ™ To Set Up and Use Your HeartWare Shoulder Pack: ® 1. Place the shoulder pack on a table or other flat surface with the clear window facing you. NOTE: For added support, attach the waist belt to the shoulder pack using the belt loops on the back of the pack before loading any equipment into it.
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Setting Up Your HeartWare HVAD System Carrying Cases ™ ™ (continued) To Set Up and Use Your HeartWare Shoulder Pack (continued): ® 6. Place the controller in the controller pocket. Figure 45 7. Fasten the snap-on buttons to secure the controller.
CAUTION: DO NOT pull, kink or twist the driveline or the power cables. Special care should be taken not to twist the driveline while sitting, getting out of bed, adjusting controller or power sources, or when using the shower bag. CAUTION: The HeartWare Waist Pack and the HeartWare Shoulder Pack contain magnetic ® ®...
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HVAD System Carrying Cases ™ ™ (continued) To Set Up and Use Your HeartWare Waist Pack: ® 1. Place the waist pack on a table or other flat surface with the clear window facing you. Attach the support strap as shown. Open the cover and undo the snaps of the controller pocket.
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Figure 60 8. Adjust the belt so that the Controller Display is visible at all times. When the HeartWare Waist Pack is comfortably ® fastened around the waist, the support strap can be removed.
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(continued) To Set Up and Use Your HeartWare Convertible Patient Pack: ® To load the Controller and batteries into the HeartWare ® Patient Pack: 1. a) Lay the bag on a flat surface. b) Open the top flap with the clear window facing you.
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HVAD Patient Manual ® Setting Up Your HeartWare HVAD System Carrying Cases ™ ™ (continued) 4. a) Fasten the clips on the Controller compartment to secure the Controller. b) Close the side flaps. Figure 65 5. a) Place each battery pack into the individual battery compartments behind the controller.
TV. The battery may last for less time as your activity level increases. However, if any battery provides less than 2 hours of support, it should be replaced. • Similar to the battery in a cell phone (or mobile phone), the HeartWare Batteries ®...
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HeartWare ™ HVAD System ™ 4.0 Emergencies and Alarms Handling an Emergency ..............Overview of Alarms ................[No Power] Alarm ................. High Alarms ....................Medium Alarms ..................Low Alarms ....................Multiple Alarms..................How to Silence (Mute) Alarms ............Changing Controller to Back-Up Controller ......
Emergencies and Alarms Handling an Emergency Emergencies may occur with your HeartWare HVAD System, with or without an ™ ™ alarm. A back-up controller and charged batteries must be available at all times. The controller should be exchanged if it fails.
HVAD Patient Manual ® Overview of Alarms Alarms tell you about the pump, controller, connections, and power sources (batteries, AC adapter, DC adapter). Alarm conditions are classified as high, medium or low. Each of these alarms has a 1) unique sound, 2) visual display and 3) a message.
Emergencies and Alarms [No Power] Alarm If both power supplies (batteries, AC adapter, DC adapter) are removed, there will be NO message on the Controller Display. A loud continuous alarm will sound but the Alarm Indicator WILL NOT light. Your pump has stopped. You need to connect power immediately.
HVAD Patient Manual ® Medium Alarms A Medium Priority Alarm may resolve on its own/without intervention, but follow the instructions on the screen and call your clinician immediately to receive instructions. Once resolved, the alarm message may remain on the Controller Display. Press the Scroll button to clear the alarm message from the Controller Display and return to the screen with VAD parameters.
Emergencies and Alarms Low Alarms A low alarm is resolved by following the instructions on the screen. Once resolved, the audible tone will stop, the alarm message will automatically clear from the controller and VAD parameters will be displayed on screen. The table below describes low alarms and possible meaning.
HVAD Patient Manual ® Multiple Alarms (continued) WARNING! NEVER disconnect both power sources (batteries, AC adapter, DC adapter) at the same time since this will stop the pump and activate the [No Power] alarm. At least one power source must be connected at all times.
Emergencies and Alarms Changing Controller to Back-Up Controller You should only change your controller when instructed to do so by your clinician, or if there is a blank display screen when attached to a functioning power supply or if the Controller Display shows one of the following: If possible, a caregiver should be nearby when doing a controller change.
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HVAD Patient Manual ® Changing Controller to Back-Up Controller (continued) Steps to Change the Controller (continued): 3. Disconnect the driveline from the original controller and connect the driveline to the new controller. This should restart your PUMP. • Verify that the pump is working. The RPM, L/min and Watts numbers should show on the Controller Display.
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Emergencies and Alarms Changing Controller to Back-Up Controller (continued) Steps to Change the Controller (continued): 4. PREVENT the [No Power] alarm from sounding on the original controller. This needs to be done before removing all power. There are 2 options, see below: •...
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HVAD Patient Manual ® Changing Controller to Back-Up Controller (continued) Steps to Change the Controller (continued): 5. Connect a second POWER source to the new controller. Figure 76 6. Be sure the driveline cover is over the silver driveline connector and the data port is covered by the dust cap.
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Emergencies and Alarms Changing Controller to Back-Up Controller (continued) When doing a controller exchange, the priority is to restart your pump quickly. It may be helpful to remember the 4 P’s: 1. POWER... Connect a power source to your back-up controller. 2.
HeartWare ™ HVAD System ™ 5.0 Preparing for Discharge Equipment Needed to Go Home ..........Discharge Instructions ..............Patient and Caregiver Training ............
Preparing for Discharge Before going home, your clinician will make sure you understand how to handle and care for your HeartWare HVAD System, care for your exit site and know what to ™ ™ do in an emergency. They will also schedule follow up appointments for you.
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HVAD Patient Manual ® Discharge Instructions (continued) 5. Take and record your blood pressure as your clinician team instructed. Reduc- ing blood pressure has been shown to reduce the risk of stroke. Your clinician will teach you how to check your blood pressure. Call your clinician if it is higher than 6.
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1. You are responsible for making sure that your surroundings continue to be safe. If you have any questions or concerns about your home environment, call your clinician. 2. Be familiar with the warnings and precautions associated with having a VAD and for safe HeartWare HVAD System operation. ™...
HVAD Patient Manual ® Patient and Caregiver Training 1. Match the item with the correct function: This icon is located at the front of Fill in your answers below: the controller and lights up when one or _____ AC Adapter more alarms occur.
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Preparing for Discharge Patient and Caregiver Training (continued) 4. Match the cable connector names on the controller: Fill in your answers below: _____ Monitor Cable / Alarm Adapter _____ Power Source _____ Power Source _____ Driveline 5. Circle True or False for the following: 1.
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4 green lights _____ % 2 green lights _____ % 3 green lights _____ % 1 yellow light _____ % 11. Check the activities that will cause the HeartWare HVAD System to stop: ™ ™ Disconnecting the AC adapter while only one fully charged battery remains connected to the controller.
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12. Two power sources should be connected to the controller at all times. What are the 3 different power options? Battery and ____________________ Battery and ____________________ Battery and ____________________ 13. Check the activities that are not allowed while on the HVAD Pump: ® Chest X-ray Cardiac Catheterization...
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HVAD Patient Manual ® Patient and Caregiver Training (continued) 16. Circle True or False for the following: 1. The RED ALARM ADAPTER silences the [No Power] alarm and should only be attached to a controller that is not connected to a pump.
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Preparing for Discharge Patient and Caregiver Training (continued) 19. To minimize the risk of interference (electrostatic discharge) to your controller due to static electricity, which of the following should you avoid? Check all that apply. Putting your controller in a silk bag Using dryer sheets when doing laundry Using a humidifier in your home Touching the TV screen while it is on...
HeartWare ™ HVAD System ™ 6.0 Living with the HeartWare HVAD ™ ™ System Medications ....................Understanding and Preventing Electrostatic Discharge (ESD) ..................Exit Site Care ..................Washing and Showering ..............Loading the Shower Bag ..............Traveling and Transport ..............
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HVAD System. Call your ™ ™ clinician if you have any questions about activities not included in this manual. WARNING! DO NOT become pregnant while you have the HeartWare HVAD System. If you are ™ ™ a woman of childbearing age, use birth control if you are sexually active. Blood thinners (which most VAD patients receive) have been associated with birth defects.
HVAD Patient Manual ® Medications Talk with your clinician about your medications. Get an explanation of the purpose of each medication that your doctor prescribes for you. Write down the medication and how often you need to take it and ask your doctor to check the list to make sure it is correct.
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Living with the HeartWare HVAD System ™ ™ Understanding and Preventing Electrostatic Discharge (ESD) (continued) WARNING! AVOID devices and conditions that may induce strong static discharges (e.g., television or computer monitor screens) as electrostatic discharges can damage the electrical parts of the system and cause the VAD to perform improperly or stop.
Report any damage to your clinician. CAUTION: ALWAYS notify your clinician promptly if you notice blood or fluid in the driveline. The section of the driveline inside your body may have been damaged during HVAD Pump ®...
The exit site should also be kept as dry as possible. Keeping the exit site dry helps avoid infections. Your clinician will decide if it is safe for you to shower. If your clinician gives you permission to shower, you must use the HeartWare Shower Bag to protect the ®...
• The shower stall should have a handrail and shower chair. WARNING! DO NOT shower until your clinician tells you it is safe to do so. If you receive permission to shower, you must use the HeartWare Shower Bag. If your hearing is impaired ®...
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Living with the HeartWare HVAD System ™ ™ Loading the Shower Bag (continued) Getting Ready to Shower Please follow these steps to place equipment in the shower bag. 1. Unzip and inspect the shower bag for rips or tears. Make sure the inside of the bag is dry.
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HVAD Patient Manual ® Loading the Shower Bag (continued) Getting Ready to Shower (continued) 6. Guide the portion of the driveline that exits the bag between the two Velcro strips on the side of the bag. ® Figure 83 7. Firmly fasten the two Velcro strips around the driveline.
• If traveling internationally, talk with your clinician about purchasing international power cords for use with your equipment. WARNING! AVOID areas with high magnetic forces such as theft detection devices or airport security systems or induction cooktops, as these may affect HeartWare HVAD System ™...
HeartWare ™ HVAD System ™ 7.0 Caring for HeartWare HVAD System ™ ™ Equipment General Care .................... Care of Your Controller ..............Care of Your Batteries ..............Care of Your Battery Charger ............Care of Your Carry and Shower Bags ........
1. Use a clean, soft cloth when cleaning the system (controller, batteries, battery charger). 2. Gently clean the equipment. Avoid hard rubbing. WARNING! DO NOT use any components other than those supplied by HeartWare with the HeartWare HVAD System, as this may affect HeartWare HVAD System operation.
HVAD Patient Manual ® Care of Your Batteries Your batteries include many features to make them safe and dependable. However, you must care for them properly. Things to Do: 1. To preserve battery life, batteries should be stored at room temperature. Protect batteries from extreme high and low temperatures.
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Caring for HeartWare HVAD System Equipment ™ ™ Care of Your Batteries (continued) Periodically or as needed: • Note how long your batteries last. If a battery lasts less than 2 hours after being fully charged, contact your clinician for a replacement.
HVAD Patient Manual ® Care of Your Battery Charger Once a week: • Inspect the battery charger for signs of physical damage, such as dents, chips, or cracks. DO NOT use the charger if it shows signs of damage. Obtain a replacement from your clinician.
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Make sure your shower bag is completely dry before taking the next shower. Inspect your shower bag for damage or wear before each use. If you have problems or questions about your HeartWare Shower ®...
Cardioversion: Controlled electrical shock used to return the heart to a normal beating pattern. Clinician: Used in this manual to reference nurses, doctors and/or VAD Coordinator. Before you are discharged home with your HeartWare HVAD System, your medical ™...
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HeartWare HVAD System: All of the components, both internal and external, ™ ™ needed to implant and run the HVAD Pump. ® High Alarm: The most serious audio and visual (flashing red) alarm. High priority alarms require immediate attention. HVAD Pump: A pumping device that sits inside your chest and is connected directly ®...
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[No Power] Alarm: An audible only alarm that sounds when both power sources are removed from the controller. Pump: A device (also known as a VAD) that moves blood from your heart to other parts of your body. The HVAD Pump is implanted at the base of your heart during ®...
Appendix Answers to Patient and Caregiver Training 1. Match the item with the correct function: This icon is located at the front of Fill in your answers below: the controller and lights up when one or _____ AC Adapter more alarms occur. _____ Alarm Indicator This button silences the low and...
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HVAD Patient Manual ® Answers to Patient and Caregiver Training (continued) 4. Match the cable connector names on the controller: Fill in your answers below: _____ Monitor Cable / Alarm Adapter _____ Power Source _____ Power Source _____ Driveline 5. Circle True or False for the following: 1.
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3 green lights _______ % 50-74 2 green lights _______ % 25-49 1 yellow light _______ % <25 11. Check the activities that will cause the HeartWare HVAD System to stop: ™ ™ Disconnecting the AC adapter while only one fully charged battery remains connected to the controller.
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3 different power options? Battery Battery and ____________________ AC (wall) Adapter Battery and ____________________ DC (car) Adapter Battery and ____________________ 13. Check the activities that are not allowed while on the HVAD Pump: ® Chest X-ray Cardiac Catheterization MRI Scan Swimming...
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Appendix Answers to Patient and Caregiver Training (continued) 16. Circle True or False for the following: 1. The RED ALARM ADAPTER silences the [No Power] alarm and should only be attached to a controller that is not connected to a pump. True False 2.
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HVAD Patient Manual ® Answers to Patient and Caregiver Training (continued) 19. To minimize the risk of interference (electrostatic discharge) to your controller due to static electricity, which of the following should you avoid? Check all that apply. Putting your controller in a silk bag...
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