Page 1 Patient Handbook...
Page 3 Thoratec Corporation III™ L EART ENTRICULAR SSIST YSTEM Patient Handbook Your guide to understanding the HeartMate III Heart Pump...
Page 4 III L EART ENTRICULAR SSIST YSTEM ATIENT ANDBOOK...
Page 5 Thoratec Corporation continually strives to provide the highest quality of products for mechanical circulatory support. Specifications may change without notice. Therefore, please refer to the HeartMate III Instructions for Use shipped with the HeartMate III Left Ventricular Assist System for the most current information regarding indications, contraindications, and cautions. Thoratec and the Thoratec logo are registered trademarks, and HeartMate III and HeartLine are trademarks of Thoratec Corporation.
Page 6 III L EART ENTRICULAR SSIST YSTEM ATIENT ANDBOOK...
Page 7 EMERGENCY CONTACT LIST It is very important that you keep a list of emergency contacts with you at all times. You may need this information if something happens to you or your pump. Before leaving the hospital, complete the following information. Call your hospital contact if you think that, for any reason, any portion of your equipment is not functioning as usual, is broken, or you are uncomfortable with the operation of the equipment.
Page 8 III L EART ENTRICULAR SSIST YSTEM ATIENT ANDBOOK...
Page 9: Table Of Contents
Calibrating HeartMate Batteries - - - - - - - - - - - - - - - - - - - - - - 3-49 Living with the HeartMate III - - - - - - - - - - - - - - 4-1...
Page 10 Contents Wearing and Carrying the System Controller - - - - - - - - - - - - - - - 4-22 Sleeping - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-62 Traveling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-63 Alarms and Troubleshooting - - - - - - - - - - - - - - 5-1 System Controller Alarms- - - - - - - - - - - - - - - - - - - - - - - - - - - 5-3...
Page 11 Contents Weekly Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - - 10-5 Monthly Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - - 10-6 Six Month Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - 10-8 Yearly Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-9 As-Needed Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - 10-9...
Page 12 Contents III L EART ENTRICULAR SSIST YSTEM ATIENT ANDBOOK...
Page 13 INTRODUCTION This section provides some introductory information about the HeartMate III™ Left Ventricular Assist Device and how to use this manual. Why Reading This Handbook is Important - - - - - - - - - - - - - - -1-3...
Page 14: Introduction
1 Introduction HeartMate III Left Ventricular Assist System Patient Handbook...
Page 15: Why Reading This Handbook Is Important
This handbook is about your HeartMate III™ Left Ventricular Assist System. It explains how the system works. It also describes daily life using the HeartMate III Left Ventricular Assist System. It explains how to use and care for equipment, and how to take care of yourself.
Page 16 Pump inside your body. Details Figure 1.1 about the Pump function are described in How Your Heart Pump Works on page 2-1. Figure 1.1 HeartMate III Left Ventricular Assist System on Battery Power HeartMate batteries with battery clips ®...
Page 17: Understanding Warnings And Cautions
In this handbook, warnings and cautions that are relevant to a specific procedure or piece of equipment appear at the start of each applicable section. WARNING ! Warnings in this handbook look like this. CAUTION ! Cautions in this handbook look like this. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 18: General Warnings
System Controller, Batteries, or Mobile Power Unit to water. If these system components get wet, your Pump may stop. Never take tub baths or go swimming while implanted with the Pump. The HeartMate III Shower Bag must be used while showering to keep the System Controller and Batteries dry.
Page 19 ICD sensing may require adjustment of device sensitivity and/or repositioning the lead. • Do not try to repair any of the HeartMate III system components. If it seems broken or in need of service, call your hospital contact. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 20: General Cautions
• The HeartMate III Left Ventricular Assist System uses lights, sounds, and on-screen messages to tell you how the system is working. If you have trouble hearing or seeing, you might need extra help to hear or see the sounds and lights. You might be at higher risk of injury if you have trouble hearing or seeing.
Page 21: Quick Reference
Charging HeartMate 14 Volt Charging HeartMate III 14 Volt Lithium-Ion Batteries Lithium-Ion Batteries on page 3-48 Showering Showering on page 4-9 Caring for the Driveline on Caring for your Driveline Exit Site page 4-6 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 22: Equipment Overview
Table 1.2 System Components Left Ventricular Assist Device The HeartMate III Left Ventricular Assist Device (often called the Pump) is implanted in the chest below the heart. One end of the Pump connects to the heart; the other end connects to the aorta (the large blood vessel that sends oxygen-rich blood through the body).
Page 23 Mobile Power Unit The Mobile Power Unit plugs into an AC outlet to provide power to the HeartMate III system and is used while indoors, stationary, or sleeping. The System Controller and the Mobile Power Unit are connected through the Mobile Power Unit patient cable.
Page 24 1 Introduction 1-12 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 25 HOW YOUR HEART PUMP WORKS This section provides information to help you understand how the HeartMate III Left Ventricular Assist Device works. Your Heart Pump - - - - - - - - - - - - - - - - - - - - - - - - - - - -2-3...
Page 26: How Your Heart Pump Works
2 How Your Heart Pump Works HeartMate III Left Ventricular Assist System Patient Handbook...
Page 27: Your Heart Pump
How Your Heart Pump Works 2 Your Heart Pump Your heart pump is called the HeartMate III Left Ventricular Assist Device, and is also referred to as the Pump ( ). It helps move blood through your body. A small Figure 2.1...
Page 28: Driveline Overview
Mobile Power Unit patient cable, which may cause damage to the wires inside, even if external damage is not visible. Damage to the Driveline or cables could cause the Pump to stop. If the Driveline or cables become twisted, kinked, or bent, carefully unravel and straighten. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 29 The Pump Cable is covered with a special material. It lets skin cells grow into the cable. Skin growth on the cable is a barrier that can lower the risk of infection. Keeping the skin clean and dry near the cable exit site also lowers infection risks. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 30: System Controller Overview
(either the Mobile Power Unit or two HeartMate 14 Volt Lithium-Ion batteries) disconnects or fails. Inappropriate use of the 11 Volt Lithium-Ion backup battery may result in diminished run time during a power-loss emergency. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 31 CAUTION ! • The System Controller uses lights, sounds, and on-screen messages to tell you how the system is operating. HeartMate III users with sight or hearing impairment may need extra help using the System Controller. • Do not drop the System Controller or subject it to extreme physical shock.
Page 32 Links the Pump to the System Controller Controller Driveline Connector Located inside the System Controller, powers [Not Shown] the Pump for at least 15 minutes during a Backup Battery (inside the System Controller) power-loss emergency HeartMate III Left Ventricular Assist System Patient Handbook...
Page 33 System Controller’s power cables. System Controller Operating Modes This section describes the System Controller’s three operating modes (Run, Sleep, and Charge) and provides an overview with instructions on how to switch between modes. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 34 Figure 2.5 System Controller User Interface Cable Disconnect Symbols Battery Button Pump Running Symbol Display Button User Interface Screen Status Symbols Silence Alarm Button 2-10 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 35 Cable Alarm the white power cable is loose or disconnects from the System Controller. This is an Advisory alarm. If this light comes on, fix the connection as soon as possible. HeartMate III Left Ventricular Assist System Patient Handbook 2-11...
Page 36 System Controller’s backup battery (the battery inside the System Controller). Pulse Mode The presence of the black triangle indicates that the HeartMate III system is operating in Pulse Mode. Once every 2 seconds, the HeartMate III Pump will automatically modify its speed to create an artificial pulse.
Page 37 Speed screen. A dot at the bottom of each screen provides navigational information about which of the five screens is in view. shows the display sequence. Table 2.3 HeartMate III Left Ventricular Assist System Patient Handbook 2-13...
Page 38 There is a fault or problem with the backup battery that could affect its reliability. Press Press display button Blank screen indicates the screen is SIX times off, which is normal. 2-14 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 39 The System Controller continually monitors the connection status of the System Controller Driveline Connector. If the System Controller detects a problem, it immediately alarms. For more information, refer to Driveline Disconnected Alarm on page 5-13. HeartMate III Left Ventricular Assist System Patient Handbook 2-15...
Page 40 Figure 2.9 Unlocking the Safety Lock Align the BLACK arrow/alignment mark on the Driveline Cable Connector with the WHITE arrow on the System Controller socket (Figure 2.10). Figure 2.10 Aligning the Arrows 2-16 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 41 Do not pull on or bend the Driveline that connects the Pump to the System Controller. Pulling on or bending the Driveline may damage wires inside, even if external Driveline damage is not visible. HeartMate III Left Ventricular Assist System Patient Handbook 2-17...
Page 42 1. Gather the equipment and place it within reach. Orient the System Controller so the display is facing down. Rotate the Safety Lock to the unlocked position (Figure 2.12). Figure 2.12 Unlocking the Safety Lock 2-18 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 43 The Left Ventricular Assist Device stops if the Driveline is disconnected from the System Controller. If the Driveline is disconnected, reconnect it as quickly as possible to restart the Pump. If the System Controller does not work, replace with a backup System Controller. HeartMate III Left Ventricular Assist System Patient Handbook 2-19...
Page 44 If the System Controller detects a problem, it immediately alarms. For more information, refer to Power Cable Disconnect Alarm on page 5-17. Figure 2.14 Power Cable Connectors White Connector Black Connector Figure 2.15 Do Not Sharply Bend the Power Cables 2-20 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 45 How Your Heart Pump Works 2 During routine use, the HeartMate III system is powered by one of two power sources: Mobile Power Unit or batteries. • Mobile Power Unit: The Mobile Power Unit plugs into an AC electrical outlet. Use it for power when indoors relaxing, and always when sleeping or when sleep is likely.
Page 46 Battery Holsters Figure 2.17 Batteries in Holsters WARNING ! The System Controller must be connected to either the Mobile Power Unit or two HeartMate 14 Volt Lithium-Ion batteries at all times. 2-22 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 47 Try to perform the self test at the same time each day so that it becomes part of your daily routine. When charging the backup System Controller every six months, self test the backup System Controller when it is in Charge mode. HeartMate III Left Ventricular Assist System Patient Handbook 2-23...
Page 48 Do not use a System Controller that fails its self test. It may need to be replaced. Refer to Replacing the Operating System Controller with a Backup Controller on page 2-40. If the System Controller fails the self test, call your hospital contact. 2-24 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 49 System Controller’s backup battery. That is, the battery inside the System Controller. For more information about checking the status of the System Controller’s backup battery, refer to Viewing Pump and System Information on page 2-13. HeartMate III Left Ventricular Assist System Patient Handbook 2-25...
Page 50 For more information, refer to Checking the Battery Charge Level on page 3-27. Mobile Power Unit Power Indicator 4 green bars = Normal Mobile Power Unit operation. 2-26 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 51 : Connected to a power source and charging the System Controller’s Charge Mode backup battery. (The backup System Controller must be put into Charge Mode every six months to charge its backup battery). HeartMate III Left Ventricular Assist System Patient Handbook 2-27...
Page 52 • Charging the backup battery inside the System Controller • Able to perform a System Controller self test For instructions on changing from Run Mode to Sleep Mode, refer to Changing Operating Modes on page 2-31. 2-28 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 53 • Responding to button pushes. • Charging the backup battery inside the System Controller For instructions on changing from Sleep Mode to Run Mode or Charge Mode, refer to Changing Operating Modes on page 2-31. HeartMate III Left Ventricular Assist System Patient Handbook 2-29...
Page 54 • Able to run System Controller self test. • Not connected to the Driveline. • Not using the user interface to show how the system is working. • Not responding to button pushes. 2-30 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 55 How Your Heart Pump Works 2 Changing Operating Modes summarizes the steps required to change between operating modes. Figure 2.24 Figure 2.24 System Controller Operating Modes HeartMate III Left Ventricular Assist System Patient Handbook 2-31...
Page 56 “Charging Complete” appears on the screen when the battery has finished charging. After the backup battery is charged, the System Controller can either be put into Run Mode for immediate use or into Sleep Mode to await future use. 2-32 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 57 1. Disconnect the backup System Controller from power. The power source can be either the Mobile Power Unit or two HeartMate batteries. The System Controller is now in Sleep Mode. HeartMate III Left Ventricular Assist System Patient Handbook 2-33...
Page 58 1 dot) appears Continue to hold down the Battery button ( ) until the countdown ends. After five seconds, the screen goes black. The System Controller is now in Sleep Mode. 2-34 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 59: System Controller Backup Power
Maintaining the Backup System Controller Readiness on page 2-38. Connecting the backup System Controller to a power source recharges its backup battery. It takes up to three hours to charge a backup battery that is without a charge. HeartMate III Left Ventricular Assist System Patient Handbook 2-35...
Page 60: Backup System Controller
2 How Your Heart Pump Works Backup System Controller HeartMate III patients receive two System Controllers: one to actively use (operating), and a reserve (backup) in case the operating System Controller experiences a failure. Backup System Controller Overview Maintaining the Backup System Controller Readiness Every six months, the backup System Controller’s...
Page 61 How Your Heart Pump Works 2 Backup System Controller Overview Every HeartMate III patient receives a backup System Controller. The backup System Controller is identical to the operating System Controller, and is programmed with the same settings as the operating System Controller. If the operating System Controller fails, it may need to be replaced with the backup System Controller.
Page 62 1. Connect the backup System Controller to a power source (Figure 2.25). The power source can be either the Mobile Power Unit or two HeartMate batteries. Figure 2.25 System Controller on Mobile Power Unit Power (left) and Battery Power (right) 2-38 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 63 Figure 2.27 System Controller Self Test Disconnect power from the backup System Controller. This will put the backup System Controller back into Sleep Mode. No further action is needed for one month. HeartMate III Left Ventricular Assist System Patient Handbook 2-39...
Page 64 Controller with Multiple Power Sources on page 2-45. Do not attempt to change your System Controller without having a IMPORTANT! trained, competent caregiver at your side to assist. Follow all alarm instructions, including calling the hospital if instructed. 2-40 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 65 2-15. page 2-15. d. Move the black connector’s d. Disconnect the old, replaced power source from the System Controller from power. operating System Controller to the backup System Controller. HeartMate III Left Ventricular Assist System Patient Handbook 2-41...
Page 66 Complete the following steps: a. Disconnect the White Power connection from the current System Controller. b. Connect the White Power connection to the replacement System Controller. c. Fully secure the white nut until tight. 2-42 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 67 System Controller Driveline Connector from the socket. d. Grasp the bend relief of the Driveline while removing it. Do not pull on or bend the System Controller Driveline Connector ( Figure 2.30 Figure 2.30 Removing the Driveline HeartMate III Left Ventricular Assist System Patient Handbook 2-43...
Page 68 Disconnect the Black Power connection from the previously operating System Controller. b. Connect the Black Power connection to the replacement System Controller c. Fully secure the black nut until tight, which is now supporting the patient. 2-44 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 69 1. If your current System Controller is alarming, silence the audio alarms for 2 minutes by pressing the Alarm Silence button Locate your replacement HeartMate III System Controller and second power source. Complete the following steps to power the replacement System Controller: a.
Page 70 Disconnect the Black Power connection from the previously operating System Controller. b. Connect the Black Power connection to the replacement System Controller. c. Fully secure the black nut until tight, which is now supporting the patient. 2-46 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 71 The screen goes black, the Pump Running symbol is black ( ), and the System Con- troller is in Sleep Mode. If this sequence is not fully completed, the System Controller will not enter Sleep Mode. HeartMate III Left Ventricular Assist System Patient Handbook 2-47...
Page 72 2 How Your Heart Pump Works 2-48 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 73 POWERING THE SYSTEM This section provides information about the various ways to power the HeartMate III Left Ventricular Assist System. Power Source Overview - - - - - - - - - - - - - - - - - - - - - - - -3-3...
Page 74: Powering The System
3 Powering the System HeartMate III Left Ventricular Assist System Patient Handbook...
Page 75: Power Source Overview
Battery Charger The Battery Charger is needed to charge, test, and calibrate the 14 Volt Lithium-Ion batteries. The Battery Charger can accommodate up to four batteries at one time. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 76: Using The Mobile Power Unit
• A Mobile Power Unit with batteries inserted • A Mobile Power Unit AC power cord • A System Controller Figure 3.1 Mobile Power Unit Speakers Status Symbols Patient Cable AC Power Receptacle HeartMate III Left Ventricular Assist System Patient Handbook...
Page 77 • Do not use the Mobile Power Unit in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide, or an explosion could occur. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 78 Power Unit. If either of these conditions is observed, separate the mobile phone from the Mobile Power Unit by at least .6 meters (24 inches). If the condition persists after separating the devices, switch to two HeartMate 14 Volt Lithium-Ion batteries. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 79 Mobile Power Unit. • Do not use equipment or supplies other than those specified or sold by Thoratec Corporation. The use of unauthorized replacement parts may affect the electromagnetic compatibility of the Mobile Power Unit with other devices. Potential interference may occur between the Mobile Power Unit and other devices.
Page 80 Before starting this task, be sure you know how to do it safely. If you have questions, call your hospital contact. 1. Place the Mobile Power Unit on a flat, sturdy surface. Ensure that the power cord is unplugged from the Mobile Power Unit. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 81 ( Figure 3.3 Figure 3.3 Removing the Battery Compartment Cover If replacing the batteries, pull the ribbon to remove the depleted batteries out of the case. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 82 Ensure that the cover is securely closed ( Figure 3.5 Figure 3.5 Tightening the Screw 10. Dispose of or recycle the depleted batteries in compliance with all applicable local, state, and federal regulations. 3-10 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 83 Plug the Mobile Power Unit into an AC electrical outlet that is dedicated to Mobile Power Unit use. CAUTION ! • Do not use an outlet that is controlled by a wall switch. • Do not use portable, multiple outlet (power strip) adapters. HeartMate III Left Ventricular Assist System Patient Handbook 3-11...
Page 84 Mobile Power Unit is ready for use. • If the green light still does not illuminate, call your hospital contact. The Mobile Power Unit may have a problem. Do not use it. 3-12 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 85 Use care when connecting and disconnecting power cables. For more information, refer to Guidelines for Power Cable Connectors on page 5-33 Figure 3.8 Mobile Power Unit Patient Cable White Connector HeartMate III Left Ventricular Assist System Patient Handbook 3-13...
Page 86 3 Powering the System Black Connector 3-14 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 87 Figure 3.9 System Controller Power Cable Connectors White Connector Black Connector Place the black and white Mobile Power Unit patient cable within reach. Place the batteries with their attached battery clips within reach. HeartMate III Left Ventricular Assist System Patient Handbook 3-15...
Page 88 Do not try to join together misaligned connectors. This can damage them. Figure 3.10 Carefully Aligning the Connectors Firmly push together the two connectors (Figure 3.11). Figure 3.11 Pushing Together the Two Connectors 3-16 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 89 Hand tighten only. Do not use tools. 14. Both System Controller power cables are now connected to the Mobile Power Unit (Figure 3.13). Figure 3.13 System Controller Power Cables Connected to Mobile Power Unit Patient Cable Connectors HeartMate III Left Ventricular Assist System Patient Handbook 3-17...
Page 90 • Never clean the Mobile Power Unit while it is providing power to the Pump. Do not put the Mobile Power Unit into water or liquid. • 1. Change to battery power. Unplug all connections. 3-18 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 91 Powering the System 3 Clean the exterior surfaces of the Mobile Power Unit using a mild detergent, and a clean, damp (not wet) cloth. HeartMate III Left Ventricular Assist System Patient Handbook 3-19...
Page 92: Using Heartmate 14 Volt Lithium-Ion Batteries
WARNING ! • Use only HeartMate 14 Volt Lithium-Ion batteries supplied by Thoratec Corporation with the HeartMate III Left Ventricular Assist System. Using the wrong batteries may cause the Pump to stop. • Charge the HeartMate 14 Volt Lithium-Ion batteries before using them. Before a battery is removed from the Battery Charger, make sure that the battery has completed its charge or calibration cycle.
Page 93 Mobile Power Unit, or two HeartMate 14 Volt Lithium Ion batteries) at all times. Do not rely on the System Controller’s backup battery, as it will only power the Pump for a limited amount of time. HeartMate III Left Ventricular Assist System Patient Handbook 3-21...
Page 94 3 Powering the System HeartMate 14 Volt Lithium-Ion Batteries Overview HeartMate batteries (Figure 3.15) are another power source for the HeartMate III Left Ventricular Assist System. Two HeartMate 14 Volt Lithium-Ion batteries are always used to power the HeartMate III Left Ventricular Assist System.
Page 95 For more information, refer to Checking the Battery Charge Level on page 3-27. For instructions on charging HeartMate batteries, refer to Charging HeartMate 14 Volt Lithium-Ion Batteries on page 3-48. HeartMate III Left Ventricular Assist System Patient Handbook 3-23...
Page 96 ). When the power cables are connected to the battery clips, battery power Figure 3.18 is supplied to the System Controller. Figure 3.18 Attaching the System Controller Power Cable to the Battery Clip 3-24 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 97 The battery clicks into place when fully and properly inserted. Pull gently on the battery to confirm that the connection is tight. Repeat Steps 2 through 5 for the second battery clip. HeartMate III Left Ventricular Assist System Patient Handbook 3-25...
Page 98 • Put the batteries and battery clips in a clean, dry location for safe storage until the next use. • Place the batteries in the Battery Charger to recharge, if needed. 3-26 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 99 Locate the lights next to the charging pocket for the battery. b. Verify that a green light is illuminated on the Battery Charger. Remove the battery from the charging pocket. Find the Battery button on the battery's power gauge. HeartMate III Left Ventricular Assist System Patient Handbook 3-27...
Page 100 Do not use it. If the battery is defective, obtain a replacement battery, if needed. on page 3-29 describes the on-battery power gauge on a 14 Volt Lithium-Ion Table 3.1 battery. 3-28 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 101 1 Bar (steady) Approximately 20–40% of power remains. 2 Bars Approximately 40–60% of power remains. 3 Bars Approximately 60–80% of power remains. 4 Bars Approximately 80–100% of power remains. 5 Bars HeartMate III Left Ventricular Assist System Patient Handbook 3-29...
Page 102 Push the battery into the clip until the battery clicks into place ( Figure 3.22 Figure 3.22 Inserting the Battery Into the Battery Clip Repeat Step 3 for the second battery and battery clip. 3-30 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 103 ( Figure 3.24 CAUTION ! Do not try to join together misaligned connectors. This can damage them. Figure 3.24 Carefully Matching the Connectors HeartMate III Left Ventricular Assist System Patient Handbook 3-31...
Page 104 Figure 3.25 Figure 3.25 System Controller Connected to Batteries Refer to Mobile Power Unit Storage on page 3-18 for information on using HeartMate 14 Volt Lithium-Ion batteries to power the system. 3-32 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 105 If the alarm does not stop after replacing batteries or changing to a different power Note: source, call your hospital contact. The System Controller or the Mobile Power Unit patient cable may need to be replaced. HeartMate III Left Ventricular Assist System Patient Handbook 3-33...
Page 106 Count the number of lights that illuminate to determine how much battery power remains for this battery. f. Repeat Steps a–e for the second battery that is currently in use. g. Determine which battery has the least power. 3-34 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 107 10. Complete the following steps to recharge the depleted batteries: a. Ensure that the Battery Charger is plugged in and turned on ("I"). b. Place each depleted battery in a Battery Charger pocket. HeartMate III Left Ventricular Assist System Patient Handbook 3-35...
Page 108 360 cycles OR 36 months from the date of manufacturer, whichever comes first. After this time, battery performance cannot be guaranteed. Call your hospital contact when a HeartMate battery reaches either of these milestones. 3-36 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 109 Place the black and white System Controller power cable connectors within reach. Unscrew and disconnect only the white System Controller and white Mobile Power Unit patient cable connectors. The Power Cable Disconnect alarm will come on. This is normal. HeartMate III Left Ventricular Assist System Patient Handbook 3-37...
Page 110 14. Place at least two additional fully-charged batteries in your travel case. CAUTION ! The Mobile Power Unit patient cable should be stored so that it will not get damaged, dirty, or wet, and so it will not cause tripping or falling. 3-38 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 111 Refer to Checking the Battery Charge Level on page 3-27. If one battery has less charge, start with that battery. Otherwise, disconnect the white connector first. Disconnect the connector from the depleted battery. HeartMate III Left Ventricular Assist System Patient Handbook 3-39...
Page 112 Ensure that the Battery Charger is plugged in and turned on ("I"). b. Place each depleted battery in a Battery Charger pocket. For more information about recharging batteries, refer to Charging HeartMate 14 Volt Lithium-Ion Batteries on page 3-48. 3-40 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 113: Using The Battery Charger
After the battery is removed from the Battery Charger, use the battery power gauge on the battery to check the battery’s charge level. • Be sure to use only equipment and supplies that are authorized by Thoratec Corporation. If unauthorized parts are used, potential interference may occur between the Battery Charger and other devices.
Page 114 3 Powering the System CAUTION ! • Use only the Battery Charger supplied by Thoratec Corporation to charge HeartMate 14 Volt Lithium-Ion batteries. Other battery chargers may damage HeartMate batteries. • Make sure the Battery Charger is plugged in and turned on before placing batteries into the pockets for charging.
Page 115 The information is displayed on the Battery Charger display panel. Figure 3.31 Batteries Inserted in Battery Charger Pockets for Charging HeartMate III Left Ventricular Assist System Patient Handbook 3-43...
Page 116 Battery is charged and ready for use. Yellow Battery is undergoing charge, test, or calibration. Yellow (Blinking) Battery requires calibration. Battery or charging pocket is defective. Do not use the battery. 3-44 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 117 Clear away any dirt or objects covering the metal contacts inside the pockets. Dirt or objects covering the metal contacts may prevent proper battery charging. This can affect battery performance. Obtain the grey AC power cord from the product packaging. HeartMate III Left Ventricular Assist System Patient Handbook 3-45...
Page 118 When the Battery Charger is turned on, all lights on the front panel illuminate ). The Battery Charger beeps once and performs a self test for about Figure 3.34 10 seconds. Figure 3.34 All Battery Charger Lights Illuminated Turned On 3-46 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 119 5-28 for information on how to respond to advisory messages. Figure 3.36 Battery Charger Error Message If traveling internationally, a Thoratec Corporation power cord set is IMPORTANT! needed. This power cord set is compatible with the local voltage and meets applicable national plug, rated voltage, rated current, and safety agency marks and specifications.
Page 120 When the battery is properly placed in the pocket, a beep sounds and one of the pocket lights illuminates (green, yellow, or red). 3-48 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 121 • If the red light is on, the battery has a problem or the charging cycle was interrupted. Refer to Confirming a Pocket Fault on page 5-31 for information on how to handle red light conditions. Repeat Steps 2–5 for up to three more batteries. HeartMate III Left Ventricular Assist System Patient Handbook 3-49...
Page 122: Viewing Battery Information
• Amount of power the battery can potentially hold if fully charged (measured in mAh) Figure 3.39 Press the Button a Second Time to Display Battery Charge Cycle Information After 10 seconds, the display panel returns to the default HeartMate CHARGER screen. 3-50 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 123: Calibrating Heartmate Batteries
Within ten seconds of the start of the blinking yellow light, press and release the number button for this pocket. The Battery Charger begins calibrating the battery. During calibration, the yellow light for this pocket remains on and HeartMate CHARGER appears on the display panel screen. HeartMate III Left Ventricular Assist System Patient Handbook 3-51...
Page 124 Calibration can take up to 12 hours. Therefore, be sure to have enough charged batteries available before calibration begins. Under normal conditions, have four charged batteries available so that batteries can be exchanged twice during a 12-hour calibration cycle. 3-52 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 125 Traveling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-63 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 126: Living With The Heartmate
4 Living with the HeartMate III HeartMate III Left Ventricular Assist System Patient Handbook...
Page 127: Living With The Heartmate Iii 4
Because each person is different, your doctor can give the best advice for your needs. To keep safe while being active, be sure to follow the guidelines in this handbook. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 128: Hand Washing
Do not touch the faucet with clean hands. 10. Repeat steps 1–9 every time before and after exit site bandage changes, any time the exit site is touched, or any time hands are dirty (or could be dirty). HeartMate III Left Ventricular Assist System Patient Handbook...
Page 129: Eating
You can make them yourself or buy them pre-made at most grocery stores and pharmacies. Talk with your hospital contact about tips for healthy eating. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 130: Caring For The Driveline
- System Controller alarming when the Driveline moves or when body position changes. - High pulsatility index (PI) readings on the System Controller. - Feeling Pump vibrations. - Fluid leaking from the external portion of the Driveline. - Device stoppage HeartMate III Left Ventricular Assist System Patient Handbook...
Page 131 Manage the Driveline exit site in accordance with the procedure provided by the clinician. A driveline management system, supplied by the implanting center, should be used at all times. The driveline management system should consist of a dressing and stabilizer. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 132 - Drainage or bleeding - Bad smell - Feeling feverish, tired, or unwell If you notice any signs of infection, call your hospital contact right away. Do not wait. Early treatment makes a difference. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 133: Showering
Warnings and Cautions WARNING ! The HeartMate III System Components must be kept dry. Never expose the System Controller, Batteries, Mobile Power Unit or Power Base Unit to water. If these system components get wet, your Pump may stop. Never take tub baths or go swimming while implanted with the Pump.
Page 134 Check all edges and ensure that the sheet completely adheres to the skin with no gaps. Figure 4.2 Sealing Around the Edges of the Sheet of Multi-Purpose Sealing Wrap With the Tape 4-10 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 135 As the wrap is removed, be careful to not disturb the driveline management system. Figure 4.3 Gently Peeling Away the Multi-Purpose Sealing Wrap and Tape If the driveline management system gets wet, change it as instructed in the previous sections. HeartMate III Left Ventricular Assist System Patient Handbook 4-11...
Page 136 4 Living with the HeartMate III Using the Shower Bag Although the external components of the HeartMate III Left Ventricular Assist System are moisture-resistant, they are not waterproof. Take care to protect system components from water or moisture, whether indoors showering or outdoors in a heavy rain. If the components have contact with water or moisture, it may cause a serious electrical shock or the Pump may stop.
Page 137 Proper hand washing is one of the easiest and best ways to reduce the spread of infection. • Do not place objects other than HeartMate III equipment in the wearable accessories. Placing objects other than HeartMate III equipment in a wearable accessory may damage the accessory.
Page 138 Shower Bag before leaving the hospital. To keep safe for showers at home, be sure to follow the guidelines in this handbook, including the warnings and cautions. 4-14 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 139 Figure 4.7 Sliding the Belt Through the Loop on the Side of the Shower Bag b. Adjust the shoulder strap and belt so that the bag fits properly. c. Tighten or lengthen the straps until they are secure, but still comfortable. HeartMate III Left Ventricular Assist System Patient Handbook 4-15...
Page 140 Unclip the top cover of the Shower Bag by squeezing the clip prongs together and sliding the clip out of the buckle (Figure 4.9). Figure 4.9 Open the Clip and Buckle on the Top of the Shower Bag 4-16 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 141 Figure 4.11 Placing the Batteries and Clips in the Shower Bag Slide the System Controller into the pocket on the inside cover of the bag, cable-free end in first and the user interface facing up. HeartMate III Left Ventricular Assist System Patient Handbook 4-17...
Page 142 Make sure that both of the System Controller’s power cables are inside the bag with only the Driveline exiting through the protective red tabs (Figure 4.13). Figure 4.13 Carefully Closing the Shower Bag; Driveline Exits Through the Protective Red Tabs 4-18 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 143 During your shower, keep the Driveline exit site as clean and dry as you can. Talk with your hospital contact for tips on keeping the exit site dry during showers. HeartMate III Left Ventricular Assist System Patient Handbook 4-19...
Page 144 Open the Shower Bag using the clip and buckle for the lid, and the left and right zippers for the top (Figure 4.16). Figure 4.16 Opening the Clip and Buckle Remove all equipment from the enclosure. 4-20 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 145 Make sure the bag is completely dry before using it again. Refer to Cleaning and Maintaining the Equipment on page 6-3 for complete instructions on caring for all wearable accessories, including the Shower Bag. HeartMate III Left Ventricular Assist System Patient Handbook 4-21...
Page 146: Wearing And Carrying The System Controller
4 Living with the HeartMate III Wearing and Carrying the System Controller Several wear and carry accessories are available for the HeartMate III system. Shower Bag The Shower Bag protects external system components from water or moisture—outside in heavy rain or snow, and always for every shower.
Page 147 Travel Bag The Travel Bag provides a convenient way to carry and transport the backup System Controller and spare batteries. Protection Bag The Protection Bag stores and protects the backup System Controller. HeartMate III Left Ventricular Assist System Patient Handbook 4-23...
Page 148 Common activities may include (but are not limited to) exercising, traveling, playing with children, gardening, hiking, cooking, and dancing. Talk with your doctor about any changes in activity level or routine. Different accessories provide different wear and carry options. 4-24 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 149 The System Controller Neck Strap (Figure 4.17) allows you to carry the System Controller around your neck or across your body. It attaches to the System Controller with two small straps. Figure 4.17 Using the System Controller Neck Strap HeartMate III Left Ventricular Assist System Patient Handbook 4-25...
Page 150 (Figure 4.19). Figure 4.18 Attachment Points on System Controller 2 of 4 Attachment Points 2 of 4 Attachment Points Figure 4.19 System Controller Suspended Horizontally (left) and Vertically (right) from Neck Strap 4-26 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 151 Choose two attachment points on the System Controller, for either vertical or horizontal wear. Slide the rubber strap on the Neck Strap through the first attachment point on the System Controller (Figure 4.21). Figure 4.21 Sliding the Strap Through an Attachment Point HeartMate III Left Ventricular Assist System Patient Handbook 4-27...
Page 152 Place the Neck Strap and System Controller on a flat, stable surface. Unbuckle the Neck Strap tabs and remove the lanyard from the System Controller. Store the Neck Strap in a clean, dry location. 4-28 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 153 OR THIS TASK YOU NEED • A quiet, well-lighted location where you can focus on the task • 1 System Controller • 1 Belt Attachment • 1 belt or the nylon belt that is provided HeartMate III Left Ventricular Assist System Patient Handbook 4-29...
Page 154 Slide either your belt or the nylon clip belt through the loop on the back of the Belt Attachment (Figure 4.26). Figure 4.26 Sliding the Belt Through the Loop on the Belt Attachment Unclip the two-banded strap on the Belt Attachment. 4-30 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 155 System Controller power cable connector and the Driveline connector (Figure 4.28). Figure 4.28 Placing the Strap Between the Connectors Clip the two-banded strap into place to secure the System Controller (Figure 4.29). Figure 4.29 Clipping the Strap Into Place HeartMate III Left Ventricular Assist System Patient Handbook 4-31...
Page 156 Unclip the two-banded strap from the Belt Attachment. b. Slide the System Controller out of the Belt Attachment and place the items on a stable surface. Store the Belt Attachment in a clean, dry location. 4-32 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 157 (black) and two designs (for right-sided carrying or left-sided carrying). A tag on the bag tells you if it is for right- or left-sided wear. Figure 4.30 Consolidated Bag Shoulder Strap Red Protective Tabs HeartMate III Left Ventricular Assist System Patient Handbook 4-33...
Page 158 The Driveline exits the bag through the protective red tabs on the side. Figure 4.31 Wearing the Consolidated Bag Consolidated Bag: version for wearing on the right side Consolidated Bag: version for wearing on the left side 4-34 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 159 Adjust the shoulder strap and belt so the bag fits you properly. b. Tighten or lengthen the strap until it is secure, but still comfortable. c. Tighten or lengthen the belt until it is secure, but still comfortable. HeartMate III Left Ventricular Assist System Patient Handbook 4-35...
Page 160 Ensure that the System Controller power cables and Driveline are not twisted (Figure 4.33). Figure 4.33 Power Cables and Driveline are Not Twisted Unzip the double zippers on the Consolidated Bag and open it. 4-36 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 161 Controller power cable and the Driveline connector. Fasten the clip to hold the System Controller in place (Figure 4.35). Figure 4.35 Strap Stretched Over the System Controller and Between the Cables HeartMate III Left Ventricular Assist System Patient Handbook 4-37...
Page 162 Figure 4.36 Placing Battery and Attached Battery Clip into Consolidated Bag Adjust the power cable so that it lays flat along the edge of the bag (Figure 4.37). Figure 4.37 Carefully Positioning the Power Cable Around the Edge of the Bag 4-38 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 163 Figure 4.38 Inserting the Second Battery 10. Arrange the power cables so that they lay flat along the edge of the bag (Figure 4.39). Figure 4.39 Arranging the Cables Around the Inside of the Bag HeartMate III Left Ventricular Assist System Patient Handbook 4-39...
Page 164 The bag should rest against your body, on the side of your body for which it was intended. b. Put the waist belt around your body and clip it into place. The belt stabilizes the bag and prevents it from moving. 4-40 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 165 For more information, refer to Changing From Batteries to the Mobile Power Unit on page 3-39. • Remove the components and transfer to another wearable accessory. Store the Consolidated Bag in a clean, dry location. HeartMate III Left Ventricular Assist System Patient Handbook 4-41...
Page 166 System Controller, which must remain with you at all times. The Protection Bag fits into the Travel Bag. Do not store or carry anything in the Protection Bag except the backup System Controller and attached power cables. 4-42 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 167 Carefully coil the cables around the System Controller inside the Protection Bag. Zip the Protection Bag closed. The backup System Controller is now stored in the Protection Bag. Keep the backup System Controller with you at all times. HeartMate III Left Ventricular Assist System Patient Handbook 4-43...
Page 168 • A quiet, well-lighted location where you can focus on the task • 1 Protection Bag with backup System Controller and power cables stored inside • 2 fully-charged HeartMate 14 Volt Lithium-Ion batteries • 1 Travel Bag 4-44 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 169 Figure 4.44 Placing the Protection Bag With Backup System Controller Inside the Travel Bag Place the spare batteries inside the Travel Bag, on either side of the Protection Bag (Figure 4.45). Figure 4.45 Storing the Batteries Inside the Travel Bag HeartMate III Left Ventricular Assist System Patient Handbook 4-45...
Page 170 (with battery clips) during battery-powered operation. This accessory distributes equipment weight across the shoulders and back. The Battery Holster comes in one size. It can be adjusted to fit most users. Figure 4.46 Battery Holster 4-46 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 171 When you wear the Battery Holster, you can exchange low-charged batteries for fully-charged batteries without taking off the holster. Refer to Exchanging Low-Power Batteries with Two Fully-Charged Batteries on page 4-51. Figure 4.47 Belt Attachment Used With Battery Holster HeartMate III Left Ventricular Assist System Patient Handbook 4-47...
Page 172 Allow the glue to dry before wearing the holster. The straps can also be stitched together through the fabric to prevent the fabric Note: connector from moving and changing the fit. 4-48 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 173 1. Gather the equipment and place it within reach. Ensure that the System Controller power cables and Driveline are not twisted (Figure 4.48). Figure 4.48 Power Cables and Driveline are Not Twisted HeartMate III Left Ventricular Assist System Patient Handbook 4-49...
Page 174 Put on and secure the Belt Attachment around your waist. Adjust and tighten the belt as needed. Refer to Putting on the Belt Attachment on page 4-29. Slide the System Controller into the Belt Attachment. 4-50 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 175 Close the Battery Holster flap. h. Repeat Steps a–g for the second low battery. Recharge the depleted batteries in the Battery Charger. Refer to Charging HeartMate 14 Volt Lithium-Ion Batteries on page 3-48. HeartMate III Left Ventricular Assist System Patient Handbook 4-51...
Page 176 Remove the System Controller from the Belt Attachment: a. Unclip the two-banded strap from the Belt Attachment. b. Slide the System Controller out of the Belt Attachment and place the items on a stable surface. 4-52 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 177 Recharge the low-charged batteries. Refer to Charging HeartMate 14 Volt Lithium-Ion Batteries on page 3-48. 10. Store the holster in a clean, dry location. Refer to Equipment Maintenance on page 6-1. HeartMate III Left Ventricular Assist System Patient Handbook 4-53...
Page 178 4 Living with the HeartMate III Using the Holster Vest Use the Holster Vest to hold the System Controller and two HeartMate batteries (with battery clips) during battery-powered operation (Figure 4.51). Figure 4.51 Holster Vest 4-54 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 179 Holster Vest, you can exchange low-charged batteries for fully-charged batteries without taking off the vest. Refer to Exchanging Batteries While Wearing the Holster Vest on page 4-59. Figure 4.52 Holster Vest With Belt Attachment and Shoulder Strap Chest Strap Belt Attachment HeartMate III Left Ventricular Assist System Patient Handbook 4-55...
Page 180 The buckle should be pointing down and the holster should face forward when you wear the vest (Figure 4.53). Figure 4.53 Inserting the Vest Strap Through the Slot in the Top of the Holster Repeat Step 2 for the second holster. 4-56 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 181 1. Gather the equipment and place it within reach. Make sure that the System Controller power cables and Driveline are not twisted (Figure 4.54). Figure 4.54 Power Cables and Driveline are Not Twisted HeartMate III Left Ventricular Assist System Patient Handbook 4-57...
Page 182 If the chest strap is used, position it higher or lower on the vest as needed, so it is secure and comfortable. Put on and secure the belt attachment around your waist. Adjust and tighten the belt as needed. Slide the System Controller into the Belt Attachment. 4-58 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 183 • A quiet, well-lighted location where you can focus on the task • 1 operating System Controller connected to two in-use HeartMate batteries during battery-powered operation • 2 fully-charged HeartMate 14 Volt Lithium-Ion batteries • 1 Holster Vest HeartMate III Left Ventricular Assist System Patient Handbook 4-59...
Page 184 Figure 4.58 Exchanging a Battery f. Repeat Steps a–e to exchange the second depleted battery. Recharge the depleted batteries. For more information, refer to Charging HeartMate 14 Volt Lithium-Ion Batteries on page 3-48. 4-60 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 185 Refer to Charging HeartMate 14 Volt Lithium-Ion Batteries on page 3-48. 10. Store the holster vest in a clean, dry place. Refer to Cleaning and Maintaining the Equipment on page 6-3. HeartMate III Left Ventricular Assist System Patient Handbook 4-61...
Page 186: Sleeping
This is very important. If you fall asleep on battery power, you might not hear low power alarms. The batteries could run out of power, and the Pump could stop before you hear the alarms. 4-62 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 187: Traveling
Mobile Power Unit. CAUTION ! For international travel, use a Thoratec Corporation power cord that is compatible with the local voltage and that meets applicable national plug, rated voltage, rated current, and safety agency marks and specifications for both the Mobile Power Unit and Battery Charger.
Page 188 Usually, there is a waiting period of at least 6–8 weeks after surgery before being considered for driving privileges. 4-64 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 189 ALARMS AND TROUBLESHOOTING This section describes the primary alarms and troubleshooting of the HeartMate III Left Ventricular Assist System. System Controller Alarms - - - - - - - - - - - - - - - - - - - - - - - -5-3...
Page 190: Alarms And Troubleshooting
5 Alarms and Troubleshooting HeartMate III Left Ventricular Assist System Patient Handbook...
Page 191: System Controller Alarms
Advisories. Refer to for a complete list of prioritized Table 5.2 Table 5.3 System Controller alarms. System Controller alarms cannot be silenced when the System Controller is IMPORTANT! in Power Saver Mode. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 192 • Power Cable Disconnect alarm (lasting over 30 seconds) • External Power Disconnected alarm • Driveline Disconnected alarm • Low Battery Power Advisory alarm • Low Battery Power Hazard alarm • Low Flow alarm HeartMate III Left Ventricular Assist System Patient Handbook...
Page 193 A dot at the bottom of each screen provides navigational information about which screen is in view ( Figure 5.2 Figure 5.2 Sample Alarm History Screen Date Format: mm-dd-yyyy Date and Time of Alarm Time Format: mm:ss Alarm Type Duration of Alarm Navigation Information HeartMate III Left Ventricular Assist System Patient Handbook...
Page 194 THIRD time to display the fourth alarm. Press Display Press button a FOURTH time to display the fifth alarm. Press Display Press button a FIFTH time to display the sixth alarm. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 195 ) light is always on when the Pump is IMPORTANT! operating. When the audio alarms are silenced, an alarm silence indicator displays ( ) on Figure 5.3 the LCD screen on the System Controller. Figure 5.3 Alarm Silence Indicator HeartMate III Left Ventricular Assist System Patient Handbook...
Page 196 Power Unit or two HeartMate 14 Volt Lithium-Ion batteries). extremely low 2. If alarm persists, call your hospital contact immediately. with less than 5 For more information, refer to page 5-15. min. remaining HeartMate III Left Ventricular Assist System Patient Handbook...
Page 197 For more information, refer to page 5-20. (Comm Fault) System Call your hospital contact as soon as possible for Controller diagnosis and instructions. Backup Battery For more information, refer to page 5-21. Fault HeartMate III Left Ventricular Assist System Patient Handbook...
Page 198 Call your hospital contact as soon as possible for Communication diagnosis and instructions. Fault (Driveline For more information, refer to page 5-24. Comm Fault) The Pump Running ight is always green on when the Pump is IMPORTANT! operating. 5-10 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 199 It may take up to 10 seconds for the Pump to restart. • 2 minutes or until a new hazard alarm occurs. Alarm silence period: • To silence this alarm, press the silence alarm button. HeartMate III Left Ventricular Assist System Patient Handbook 5-11...
Page 200 Call your hospital contact immediately for diagnosis and To resolve alarm: instructions. • 2 minutes or until a new hazard alarm occurs. Alarm silence period: • To silence this alarm, press the silence alarm button. 5-12 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 201 • To silence this alarm, press the silence alarm button. Alarm silence period: Note: In some cases, you may have to push the silence alarm button twice to silence this alarm. This is normal. HeartMate III Left Ventricular Assist System Patient Handbook 5-13...
Page 202 Pump from stopping. When adequate power is supplied, the Pump reverts to the previous speed and the red battery alarm clears. 5-14 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 203 2. Call your hospital contact right away if connecting to power does not resolve the alarm. • 2 minutes or until a new hazard alarm occurs. Alarm silence period: • To silence this alarm, press the silence alarm button( HeartMate III Left Ventricular Assist System Patient Handbook 5-15...
Page 204 A backup System Controller is identical to the System Controller. It should IMPORTANT! remain with you at all times for easy access in an emergency. For instructions on replacing the System Controller, refer to page 2-40. 5-16 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 205 (Mobile Power Unit or two fully-charged HeartMate batteries). To resolve alarm: 2. Call your hospital contact if reconnecting the power cable does not resolve the alarm. None: The alarm cannot be silenced. Alarm silence period: HeartMate III Left Ventricular Assist System Patient Handbook 5-17...
Page 206 2. Call your hospital contact if connecting to power does not resolve the alarm. • 5 minutes or until any new alarm occurs. Alarm silence period: • To silence this alarm, press the silence alarm button( 5-18 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 207 A backup System Controller is identical to the System Controller. It should IMPORTANT! remain with you at all times for easy access in an emergency. For instructions on replacing the System Controller, refer to page 2-40. HeartMate III Left Ventricular Assist System Patient Handbook 5-19...
Page 208 Call your hospital contact immediately for diagnosis To resolve alarm: and instructions. • 4 hours or until any new alarm occurs. Alarm silence period: • To silence this alarm, press the silence alarm button 5-20 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 209 Call your hospital contact as soon as possible for diagnosis To resolve alarm: and instructions. • 4 hours or until any new alarm occurs. Alarm silence period: • To silence this alarm, press the silence alarm button( HeartMate III Left Ventricular Assist System Patient Handbook 5-21...
Page 210 Call your hospital contact as soon as possible for diagnosis To resolve alarm: and instructions. • 4 hours or until any new alarm occurs. Alarm silence period: • To silence this alarm, press the silence alarm button( 5-22 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 211 Call your hospital contact immediately for diagnosis and To resolve alarm: instructions. • 4 hours or until any new alarm occurs. Alarm silence period: • To silence this alarm, press the silence alarm button ( HeartMate III Left Ventricular Assist System Patient Handbook 5-23...
Page 212 Call your hospital contact immediately for diagnosis and To resolve alarm: instructions. • 4 hours or until any new alarm occurs. Alarm silence period: • To silence this alarm, press the silence alarm button ( 5-24 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 213: Mobile Power Unit Alarms
When the Mobile Power Unit is connected to the System Controller, the Mobile Note: Power Unit duplicates any active audio System Controller alarms. Refer to System Controller Alarm Management on page 5-3. HeartMate III Left Ventricular Assist System Patient Handbook 5-25...
Page 214 1. Promptly switch to two fully-charged Internal malfunction Advisory Alarm HeartMate 14 Volt Lithium-Ion batteries. detected within the Yellow wrench light Mobile Power Unit. 2. Call hospital contact. with beeping audio tone 5-26 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 215: Battery Charger Alarms
The Battery Charger can detect a problem or fault condition in up to four charging pockets at once (with or without batteries inserted), or with the entire Battery Charger unit. The Battery Charger alerts you immediately of any problem. HeartMate III Left Ventricular Assist System Patient Handbook 5-27...
Page 216 X: mAh = C X: mAh = XC screen) READY Charge Complete Y: █ █ █ █ █ CALIBRATE? Request Calibration PRESS Y PROGRESS Y: CALIBRATING Accept Calibration CALL SERVICE Charger Fault 5-28 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 217 Figure 5.5 Telephone Symbol and Red Light by Pocket 1 Indicate that the Charger Detects a Problem Before assuming that the battery is defective, make sure that the connection between the battery and charging pocket contacts is not blocked by dirt or debris. HeartMate III Left Ventricular Assist System Patient Handbook 5-29...
Page 218 The alarm code appears on the screen. The alarm code is one letter followed by four numbers. Alarm codes related to batteries begin with the letter B. b. Record the alarm code and save it for future reference. Remove the defective battery from use. 5-30 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 219 Call your hospital contact for help. The hospital contact may ask for the alarm code. Do not use the defective charging pocket until it is repaired or until the Note: Battery Charger is replaced. You can continue to use the other pockets. HeartMate III Left Ventricular Assist System Patient Handbook 5-31...
Page 220 Do not use a damaged or defective Battery Charger until it is repaired or replaced. Note: Until you have a safe and reliable way to recharge batteries, use the Mobile Power Unit to power your HeartMate III system. 5-32 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 221: Guidelines For Power Cable Connectors
• When disconnecting, turn the nut on the connector until the connection is loose, and then gently pull the connectors apart. • Never twist connectors or pull them apart at an angle. HeartMate III Left Ventricular Assist System Patient Handbook 5-33...
Page 222: What Not To Do: Driveline And Cables
Left Ventricular Assist Device to stop. If the Driveline or cables become twisted, kinked, or bent, carefully unravel and straighten. CAUTION ! Do not twist, kink, or sharply bend the Driveline. 5-34 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 223 Alarms and Troubleshooting 5 CAUTION ! Do not twist, kink, or sharply bend the System Controller power cables. HeartMate III Left Ventricular Assist System Patient Handbook 5-35...
Page 224 • Route the patient cable so it will not cause a tripping or falling hazard. • Take care when moving around while connected to the Mobile Power Unit, that it is not inadvertently pulled off of furniture. 5-36 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 225 Alarms and Troubleshooting 5 HeartMate III Left Ventricular Assist System Patient Handbook 5-37...
Page 226 5 Alarms and Troubleshooting 5-38 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 227 EQUIPMENT MAINTENANCE This section provides information about how to clean and maintain the HeartMate III Left Ventricular Assist System, and the wear and carry accessories. Cleaning and Maintaining the Equipment - - - - - - - - - - - - - - -6-3...
Page 228: Equipment Maintenance
6 Equipment Maintenance HeartMate III Left Ventricular Assist System Patient Handbook...
Page 229: Cleaning And Maintaining The Equipment
Do not disconnect the System Controller from the Driveline for cleaning. IMPORTANT! Disconnecting the Driveline will make the Pump stop. The Driveline connector should be inspected only if the System Controller is replaced. Refer to Backup System Controller on page 2-36. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 230 A disruption to the continuity of the wires in the Driveline may cause damage to the System Controller. If damage to the System Controller occurs and the System Controller requires replacement, consider using batteries to reduce the potential of further damaging the System Controller. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 231 Allow the alcohol to dry before using newly cleaned batteries or clips. Do not clean batteries while the batteries are in use. Figure 6.1 Cleaning the Contacts on the Batteries and Battery Clips HeartMate III Left Ventricular Assist System Patient Handbook...
Page 232 HeartMate wear and carry accessories are designed to securely hold, carry, and protect HeartMate III components. Periodically inspect the wear and carry accessories for damage or wear. If an accessory appears damaged or worn, do not use it. Call your hospital contact for a replacement.
Page 233: Product Disposal
Battery Charger Disposal Dispose of or recycle the Battery Charger and Battery Charger electronics in compliance with all applicable local, state, and federal regulations. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 234 6 Equipment Maintenance HeartMate III Left Ventricular Assist System Patient Handbook...
Page 235 FREQUENTLY ASKED QUESTIONS This section provided answers to commonly asked questions about the HeartMate III Left Ventricular Assist Device. System Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -7-3...
Page 236: Frequently Asked Questions
7 Frequently Asked Questions HeartMate III Left Ventricular Assist System Patient Handbook...
Page 237: System Use
No. Only use the HeartMate 14 Volt Lithium-Ion batteries that you received from the hospital at discharge. Other batteries will not power the HeartMate III system. Trying to use other batteries for power may cause your Pump to stop. If you need new or extra batteries, call your hospital contact.
Page 238: Showers And Exercise
Shower Bag for every shower. Do not shower without the Shower Bag. Can I exercise, play sports, or go to the gym? Many HeartMate III patients enjoy an active lifestyle. However, it is not safe to play contact sports or engage in jumping activities while you have the Pump. These activities could cause bleeding or could damage the Pump.
Page 239: Travel
Many new users worry about doing something that could stop the Pump. Try not to worry. The HeartMate III system is designed for safe and easy use at home. It has built-in backups. As long as the Pump is connected to power (the Mobile Power Unit or two HeartMate batteries), it will continue to run.
Page 240 7 Frequently Asked Questions HeartMate III Left Ventricular Assist System Patient Handbook...
Page 241 What Is An Emergency? - - - - - - - - - - - - - - - - - - - - - - - -8-3 How to Handle an Emergency - - - - - - - - - - - - - - - - - - - - -8-4 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 242: Handling Emergencies
8 Handling Emergencies HeartMate III Left Ventricular Assist System Patient Handbook...
Page 243: What Is An Emergency
Land-line telephones may be less likely to be affected by interference, interruptions, or power outages. Make sure you have completed the Emergency Contact List on page v and keep it available at all times. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 244: How To Handle An Emergency
Refer to Alarms and Troubleshooting on page 5-1 for instructions on handling Note: alarms. When the Pump has Stopped (Red Heart Alarm) If the Pump stops operating, you will see the Red Heart alarm and the Pump Running symbol is black: HeartMate III Left Ventricular Assist System Patient Handbook...
Page 245 Controller with a Backup Controller on page 2-40. If checking connections, switching power sources, or changing system controllers does not fix the problem, call emergency services right away (dial 911 if available), and then call your hospital contact. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 246 8 Handling Emergencies HeartMate III Left Ventricular Assist System Patient Handbook...
Page 247 Acceptable Operating Conditions - - - - - - - - - - - - - - - - - - -9-4 Declaration Concerning General Safety Standards - - - - - - - - - - -9-5 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 248: Testing And Classification
9 Testing and Classification HeartMate III Left Ventricular Assist System Patient Handbook...
Page 249: Safety Testing And Classification
Testing and Classification 9 Safety Testing and Classification The HeartMate III Left Ventricular Assist System has been thoroughly tested and Classified by Underwriters Laboratories, LLC (UL) to the fire, casualty, and electric shock hazard requirements of the following safety standards, as applicable: •...
Page 250: Acceptable Operating Conditions
Refer to Maintaining the Backup System Controller Readiness on page 2-36. Patients must maintain the equipment in Table 9.1 within the stated operating Note: conditions at all times. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 251: Declaration Concerning General Safety Standards
• System Controller For additional information on testing and classification for the HeartMate III Left Ventricular Assist System, refer to the HeartMate III Instructions for Use. Your hospital contact can get a copy for you. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 252 9 Testing and Classification Testing and Classification: HeartMate III LVAS The HeartMate III Left Ventricular Assist System has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Page 253 Testing and Classification: Mobile Power Unit Declaration and Guidance for Electromagnetic Disturbances for the Mobile Power Unit The HeartMate III Left Ventricular Assist System (powered by the Mobile Power Unit) is suitable for use in the following environments: • Hospitals, including ORs and emergency rooms •...
Page 254 RFID readers. Interference to the HeartMate III LVAS may occur near equipment or areas that are marked with the following symbol: Note: 1,000 MHz = 1.0 GHz [a] – List is not comprehensive. HeartMate III Left Ventricular Assist System Patient Handbook...
Page 255 2-Watt of transmit power) and its parts (cables, antennas, etc.) operating in the frequencies shown here should not be closer to the HeartMate III LVAS with Mobile Power Unit, and its parts, than 0.2 m (8 inches). 380 - 390 MHz, 42 V/m...
Page 256 (0.5 sec.) EN 61000-4-11 0 % of U ; 250 or 300 cycles (5 sec.) Note – U : A.C. Mains voltage supply, either 50 or 60 Hz (cycles per sec.) 9-10 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 257 HeartMate III LVAS, be certain to follow the maintenance schedule and procedures as described in Equipment Maintenance. • Avoid use of HeartMate III LVAS (and its cables and parts) within 5 cm (2 inches) of a microwave oven or its cord.
Page 258 Table 9.4 Declaration Concerning General Safety Standards for Battery Charger Type Degree of Protection Mode of Operation Continuous Type of protection against mains shock Class I (grounded) Degree of protection against harmful ingress IPX0 of water 9-12 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 259 Testing and Classification 9 Declaration and Guidance for Electromagnetic Disturbances for Battery Charger The HeartMate III Battery Charger is suitable for use in the following environments: • Hospitals, including ORs and emergency rooms • Homes, workplaces and retail places • Public or private passenger watercraft/boats, ferries, etc.
Page 260 Interference to the HeartMate Battery Charger may occur near equipment or areas that are marked with the following symbol: Note: 1,000 MHz = 1.0 GHz [a] – List is not comprehensive. 9-14 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 261 HeartMate Battery ± 0.5, ± 1 kV line to line Charger is used. Surge Immunity / IEC 61000-4-5 EN 61000-4-5 ± 0.5, ± 1 kV, and ± 2 kV line to earth HeartMate III Left Ventricular Assist System Patient Handbook 9-15...
Page 262 Charger is used. IEC 61000-4-11 (0.5 sec.) EN 61000-4-11 0 % of U ; 250 or 300 cycles (5 sec.) : A.C. Mains voltage supply, either 50 or 60 Hz (cycles per sec.) 9-16 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 263 (EMC) “site survey” (measurement) should be considered. If the measured field strength (in Volts per meter, V/m) in the location(s) in which the HeartMate III Left Ventricular Assist System is used exceeds the applicable RF compliance level for the frequency bands above, the HeartMate III LVAS should be observed to verify normal operation.
Page 264 IP24 only when connected to the System Degree of protection against harmful ingress Controller through Clip 9-18 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 265 The HeartMate III Left Ventricular Assist System with 14 Volt Lithium-Ion batteries is intended for use in the electromagnetic environment specified below. The customer or the user of the HeartMate III Left Ventricular Assist System should assure that it is used in such an environment.
Page 266 Interference to the HeartMate III LVAS may occur near equipment or areas that are marked with the following symbol: Note: 1,000 MHz = 1.0 GHz [a] – List is not comprehensive. 9-20 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 267 (up to 2-Watt max. of transmit power) and its parts (cables, antennas, etc.) operating in the frequencies shown here should not be closer to the HeartMate III LVAS with 14V Li-Ion Batteries, and its parts, than 0.2 m (8 inches).
Page 268 Magnetic Field Immunity / be that of a typical commercial or hospital 30 A/m (50 or 60 Hz) IEC 61000-4-8 environment where the HeartMate III LVAS EN 61000-4-8 with14V Li-Ion Batteries is used. 9-22 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 269 • Avoid use of HeartMate III LVAS (and its cables and parts) within 5 cm (2 inches) or a microwave oven or its cord.
Page 270 Use of equipment and supplies other than those specified in the manuals or sold by Thoratec Corporation for replacement parts may affect the electromagnetic compatibility of the Left Ventricular Assist System with other devices, resulting in potential interference between the HeartMate III Left Ventricular Assist System and other devices. 9-24...
Page 271 As-Needed Safety Checklist- - - - - - - - - - - - - - - - - - - - - - 10-9 Clinic Visit Safety Checklist - - - - - - - - - - - - - - - - - - - - - 10-10 HeartMate III Left Ventricular Assist System Patient Handbook 10-1...
Page 272: Safety Checklists
10 Safety Checklists 10-2 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 273: Daily Safety Checklist
When the Mobile Power Unit is initially connected to power, check the top panel and ensure that the Power On symbol ( ) is illuminated green. Ensure that the Mobile Power Unit echoes the System Controller’s alarms. HeartMate III Left Ventricular Assist System Patient Handbook 10-3...
Page 274 Ensure that the Modular In-line Connector is secure and the connector locking nut is in the locked position. Ensure no yellow indicator is seen under the in-line locking nut. Inspect all cables for signs of damage. 10-4 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 275: Weekly Safety Checklist
Attachment accessory) for damage or wear. Inspect the Battery Holster for damage or wear. Inspect the Shower Bag for damage or wear. Replace any equipment or system component that appears damaged or worn. HeartMate III Left Ventricular Assist System Patient Handbook 10-5...
Page 276: Monthly Safety Checklist
Report the condition to your hospital contact. Cleaning and service should be performed only by Thoratec-trained personnel. Do not attempt to clean or repair equipment on your own. If the Mobile Power Unit is going to be stored for over 1 month, remove the Mobile Power Unit batteries.
Page 277 Allow the alcohol to completely air dry before inserting batteries into the pockets. Do not clean the Battery Charger while it is plugged in. Replace any equipment or system component that appears damaged or worn. HeartMate III Left Ventricular Assist System Patient Handbook 10-7...
Page 278: Six Month Safety Checklist
Replace the Mobile Power Unit batteries with three new AA Alkaline batteries. If corrosion is observed, discontinue use of the Mobile Power Unit and call your hospital contact. Refer to Inserting or Replacing the Mobile Power Unit Batteries on page 3-8. 10-8 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 279: Yearly Safety Checklist
Safety Checklists 10 Yearly Safety Checklist Schedule a Battery Charger inspection and cleaning with Thoratec-trained personnel. The safety inspection and cleaning includes (but is not limited to) functional testing, cleaning, and inspection. REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN.
Page 280: Clinic Visit Safety Checklist
Review using the Shower Bag and showering (Patient Handbook section 4). Review caring for the Driveline exit site including cleansing, dressing, and immobilizing the Driveline (Patient Handbook section 4). System Controller must be maintained and assessed for readiness. 10-10 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 281 Terms - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-4 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 282: 11 Glossary
11 Glossary 11-2 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 283 Left Ventricular Assist System Low Molecular Weight Ml/hr Milliliter per hour Magnetic Resonance Imaging O.R. Operating Room Pulsatility Index Partial Thromboplastin time Once daily Revolutions Per Minute Three times daily Volt HeartMate III Left Ventricular Assist System Patient Handbook 11-3...
Page 284: Terms
North American households. Apical Cuff: The Apical Cuff is the interface between the heart and the HeartMate III LVAD. It is sewn to the exterior of the heart and anchors it to the LVAD via the Slide Lock.
Page 285 Cautions: Actions to avoid that could damage equipment or affect how the system works. Although important for system function, cautions do not usually relate to life-threatening risks. Communication Fault (Comm Fault): An Advisory alarm indicating the HeartMate III LVAD and System Controller cannot properly exchange information. Controller: See System Controller.
Page 286 Hazard alarms are serious conditions that require immediate attention. Hazard alarms are indicated by a red light and continuous audio tone. HeartMate III Left Ventricular Assist System: Includes the pump and Driveline, as well as the System Controller, power sources (Mobile Power Unit or batteries), and accessories.
Page 287 Low Flow Hazard Symbol: Red heart light ( ) on the System Controller. It lights when HeartMate III pump blood flow is critically low. Low Speed Limit: The lowest speed at which the HeartMate III pump can operate while maintaining patient stability. Magnetic Resonance Imaging ( ) MR is unsafe for HeartMate III patients.
Page 288 Power Saver Mode. Alarms cannot be silenced while in Power Saver Mode. Power Sources: Three power sources can power the HeartMate III Left Ventricular Assist System: • A pair of wearable, rechargeable 14 Volt Lithium-Ion batteries worn in battery clips •...
Page 289 It does not fix the alarm condition. Silence Alarm Screen: When the audio portion of the alarms are silenced, the symbol will display on the LCD screen of the System Controller. HeartMate III Left Ventricular Assist System Patient Handbook 11-9...
Page 290 System Controller. For example, the System Controller can be carried with a strap around the neck, on a belt around the waist, or in a pocket. A battery holster is used for carrying batteries and battery clips. 11-10 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 291 HeartMate 14 Volt Lithium-Ion batteries providing power during battery-powered operation. Yellow Wrench Indicator: A yellow-colored symbol ( ) on the System Controller user interface that illuminates during alarm conditions that are important, but not immediately life-threatening. HeartMate III Left Ventricular Assist System Patient Handbook 11-11...
Page 292 11 Glossary 11-12 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 293 3-34 alarm history, viewing calibrating 3-49 alarm silence indicator charging 3-39 alarms checking charge level 3-25 advisory alarms connecting to System Controller 3-28 System Controller clock not set 5-22 disposal HeartMate III Left Ventricular Assist System Patient Handbook Index-1...
Page 294 Driveline 2-15 overview 1-10 Mobile Power Unit patient cable 3-13 estimating battery time 3-31 power cable 2-20 consolidated bag 4-33 Controller Glossary 11-1 advisory alarms audio alarms 2-13 backup power 2-35 Index-2 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 295 2-25 buttons 2-11 Charge Mode on-battery power gauge 2-30 3-25 cleaning operating modes for System Controller 2-27 connecting Driveline to System Controller 2-16 power cable connecting to batteries 3-28 HeartMate III Left Ventricular Assist System Patient Handbook Index-3...
Page 296 2-27 System Controller Fault Alarm 5-19 temperature requirements temperature, acceptable ranges for operation travel by automobile 4-64 travel bag 4-44 troubleshooting user interface on System Controller 2-10 vest, holster 4-54 Index-4 HeartMate III Left Ventricular Assist System Patient Handbook...
Page 298 Therefore, please refer to the HeartMate III Instructions for Use shipped with the HeartMate III for the most current information regarding indications, contraindications, and cautions. Thoratec and the Thoratec logo are registered trademarks and HeartMate III and HeartLine are trademarks of Thoratec Corporation.

Thoratec HeartMate III Patient Handbook

1 Introduction

2 How Your Heart Pump Works

3 Powering the System

4 Living with the Heartmate III 4

5 Alarms and Troubleshooting

6 Equipment Maintenance

7 Frequently Asked Questions

8 Handling Emergencies

9 Testing and Classification

10 Safety Checklists

11 Glossary

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