Page 3 Thoratec Corporation ® EART ENTRICULAR SSIST YSTEM Patient Handbook Your guide to understanding the HeartMate II heart pump...
Page 5 Belgium +32 2 774 68 11 Website: www.thoratec.com 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 II Instructions for Use shipped with the HeartMate II Left Ventricular Assist System for the most current information regarding indications, contraindications, and cautions.
Page 7 Emergency Services Dial 911 (Confirm 911 is operational in your area.) Other Important Information Consider making several copies of this list and leave it in different places for easy access and reference. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 9: Table Of Contents
Calibrating HeartMate 14 Volt Lithium-Ion Batteries - - - - - - - - - - - - 109 Living with the HeartMate II- - - - - - - - - - - - - - 111 Keeping Your Home Safe - - - - - - - - - - - - - - - - - - - - - - - - - 113...
Page 10 What Is An Emergency? - - - - - - - - - - - - - - - - - - - - - - - - - - 235 viii HeartMate II Left Ventricular Assist System Patient Handbook...
Page 11 Terms - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 280 HeartMate II Left Ventricular Assist System Patient Handbook...
Page 13: Introduction
INTRODUCTION This section provides some introductory information about the HeartMate II Left Ventricular Assist Device and how to use this manual. Why Reading This Handbook is Important - - - - - - - - - - - - - - - -3 Understanding Warnings &...
Page 15: Why Reading This Handbook Is Important
Why Reading This Handbook is Important Be Informed This handbook is about your HeartMate II Left Ventricular Assist System. It explains how the system works. It also describes what daily life is like. It tells you how to use and care for equipment and how to take care of yourself. What to do in an emergency is also covered.
Page 16 Driveline System Controller The figure above shows the following: • Implanted HeartMate II Left Ventricular Assist Device (“heart pump”) • HeartMate batteries, with battery clips and worn in holsters (during battery-powered operation) • Driveline (connects the pump to the System Controller) exiting the body •...
Page 17: Understanding Warnings & 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 II Left Ventricular Assist System Patient Handbook...
Page 18: General Warnings
Read this entire handbook before use. • Understanding the operating and the safety aspects of the HeartMate II Left Ventricular Assist System is critical for safe and successful use. •...
Page 19: General Cautions
Never have therapeutic radiation while you have the pump. • Do not try to repair any of the HeartMate II system components. If it seems broken or in need of service, call your hospital contact. General Cautions CAUTION ! •...
Page 20: Equipment Overview
1 Introduction CAUTION ! (Continued) • The HeartMate II Left Ventricular Assist System has been extensively tested for electromagnetic compatibility (EMC). The system will operate under normal conditions of everyday living. However, conditions and situations that can generate abnormally high levels of electromagnetic energy should be avoided.
Page 21 10–12 hours. For more information, see page 75. The Mobile Power Unit plugs into an AC outlet to provide power to the HeartMate II system and is used Mobile Power Unit while indoors, stationary, or sleeping. The System Controller and the Mobile Power Unit are connected through the Mobile Power Unit patient cable.
Page 22 For more information, see page 144. Consolidated Bag The Consolidated Bag is a convenient way to wear and carry the System Controller and batteries. For more information, see page 148. Table 1 System Components (Continued) HeartMate II Left Ventricular Assist System Patient Handbook...
Page 23 System Controller and spare batteries. For more information, see page 159. Protection Bag The Protection Bag stores and protects the backup System Controller. For more information, see page 157. Table 1 System Components (Continued) HeartMate II Left Ventricular Assist System Patient Handbook...
Page 25: How Your Heart Pump Works
HOW YOUR HEART PUMP WORKS This section provides information to help you understand how the HeartMate II Left Ventricular Assist Device works. Your Heart Pump - - - - - - - - - - - - - - - - - - - - - - - - - - 15...
Page 26 2 How Your Heart Pump Works HeartMate II 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 II Left Ventricular Assist Device ( Figure 2 It helps move blood through your body. A small motor inside the pump turns the rotor that moves the blood. The pump is placed below the heart. One end connects to the left ventricle (the heart’s main pumping chamber).
Page 28: The Driveline
Caring for the Driveline Exit Site infection risks. See on page 129 for details on exit site care. “Percutaneous” means “through the skin.” You may hear this term used to describe the driveline. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 29 If the driveline or cables become What Not To twisted, kinked, or bent, carefully unravel and straighten. See Do: Driveline and Cables on page 212. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 30: The System Controller
Alarm with lights, sounds, and on-screen messages. • Record and store data in its memory. • Send data to devices that are used by nurses and doctors to control operation and to find, understand, and fix problems. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 31 See page 40. System Controller Operating Modes. The System Controller has three operating modes: Run, Sleep, and Charge. This section provides an overview with instructions on how to switch between modes. See page 43. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 32 The Shower Bag protects external system components from water or moisture. If external system components have contact with water or moisture, you may get a bad electric shock or the pump may stop. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 33 Risk of fire and burns. Do not open, crush, heat above 104°F (40°C), or incinerate a battery. Follow manufacturer’s instructions. • Malfunction of internal backup battery may cause the controller to become excessively hot. If this occurs, switch to the backup System Controller. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 34 CAUTION ! • The System Controller uses lights, sounds, and on-screen messages to tell you how the system is running. HeartMate II 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 35 System Controller is in use. • Use only those accessories specified or sold by Thoratec. Do not cover the System Controller with insulating material, such as a blanket, to avoid elevated temperature.
Page 36 System Controller alarms and how to resolve them, see Controller Alarms on page 185. introduces the main parts of the user interface. These parts are described in Table 2 more detail later in this section. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 37 Alarm Symbol System Controller. This is an Advisory alarm. If this light comes on, fix the connection as soon as possible. For more information, see page 198. Table 2 System Controller User Interface HeartMate II Left Ventricular Assist System Patient Handbook...
Page 38 5 seconds and then releasing it. For more information, see page 50. Table 2 System Controller User Interface (Continued) HeartMate II Left Ventricular Assist System Patient Handbook...
Page 39 ) and the display button ( ) at the same time to display the last six System Controller alarms on the screen. For more information, see page 187. Table 2 System Controller User Interface (Continued) HeartMate II Left Ventricular Assist System Patient Handbook...
Page 40 (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 3 HeartMate II Left Ventricular Assist System Patient Handbook...
Page 41 Table 3 System Controller Display Screen Sequence On-screen messages come in many different languages. Talk with your Note: hospital contact about selecting the language that is best for your needs. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 42 The System Controller continually monitors the connection status of the driveline connector. If the System Controller detects a problem, it immediately alarms. For Driveline Disconnected Alarm more information, see on page 193. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 43 Figure 8 Unlock the Safety Tab Align the arrow/alignment mark on the driveline with the arrow on the System Controller socket ( Figure 9 Figure 9 Align Arrow on Driveline With Arrow on System Controller HeartMate II Left Ventricular Assist System Patient Handbook...
Page 44 If there is a problem with the connection, the System Controller immediately alarms with a Driveline Disconnected alarm. Driveline Disconnected Alarm This is a Hazard alarm. See on page 193 for details. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 45 Firmly press the red button under the safety tab, while removing the driveline from the socket ( ). Grasp only the metal end. Do not pull on or bend Figure 12 the driveline. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 46 2 How Your Heart Pump Works Figure 12 Remove Driveline from Socket on System Controller Call your hospital contact if you are unable to remove the driveline. IMPORTANT! HeartMate II Left Ventricular Assist System Patient Handbook...
Page 47 If the System Controller detects a problem, it immediately alarms. For Power Cable Disconnected Alarm more information, see on page 198. Figure 13 Power Cable Connectors White Connector Black Connector Figure 14 Do Not Sharply Bend the Power Cables HeartMate II Left Ventricular Assist System Patient Handbook...
Page 48 2 How Your Heart Pump Works During routine use, the HeartMate II system is powered by one of two power sources, the Mobile Power Unit or batteries, as described below. • Mobile Power Unit: The Mobile Power Unit plugs into an AC electrical outlet.
Page 49 Figure 16 Batteries in Holsters Battery Power See page 79. WARNING ! The System Controller must be connected to either the Mobile Power Unit or two Heart- Mate 14 Volt Lithium-Ion batteries at all times. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 50 The self test should be done at least once per day on the running System Controller. Try to perform the self test at the same time each day so that it becomes part of your daily routine. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 51 Do not use a System Controller that fails its self test. It may need to be replaced (see Replacing the Running System Controller with a Backup Controller on page 54). If the System Controller fails the self test, call your hospital contact. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 52 System Controller’s backup battery (the battery inside the System Controller). To Viewing Pump and check the status of the System Controller’s backup battery, see System Information on the Screen on page 28. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 53 Checking a source of power using four green bars. For more information, see Battery’s Charge Level on page 83. On Mobile Power Unit power: 4 green bars = Normal Mobile Power Unit operation. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 54 If either the yellow diamond or the red battery illuminate, immediately replace the depleted batteries with a fully-charged pair, or switch to the Mobile Power Unit (see Changing from Batteries to Mobile Power Unit Power on page 95). HeartMate II Left Ventricular Assist System Patient Handbook...
Page 55 • Connected to the driveline. • Sending power to the pump through the driveline. • Controlling and checking operating conditions. • Using the user interface to show how the system is working. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 56 Not connected to the driveline. • Not using the user interface to show how the system is working. • Not responding to button pushes. • Not charging the backup battery inside the System Controller. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 57 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. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 58 Figure 23 System Controller Operating Modes Running Disconnect power source Disconnect driveline Hold the Battery Button for 5 seconds Connect power source Connect driveline Connect driveline Sleep Disconnect Charge power source Connect power source HeartMate II Left Ventricular Assist System Patient Handbook...
Page 59 Connect the driveline to the System Controller (see to the System Controller on page 31). The System Controller is now in Run Mode. Confirm that the Pump Running symbol is illuminated green on the System Controller. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 60 “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. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 61 Disconnect the backup System Controller from power (either the Mobile Power Unit or two HeartMate 14 Volt Lithium-Ion batteries). The System Controller is now in Sleep Mode. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 62 “Hold” and a reverse count down of dots (5 dots, 4 dots, 3 dots, 2 dots, 1 dot) 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. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 63: System Controller Backup Power
Failure to charge the 11 Volt Lithium-Ion backup battery inside the backup System Controller may result in no support during a power-loss emergency when the backup System Controller is in use. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 64 That is why your hospital contact needs you to bring your backup System Controller to him or her once every six months so that it can be checked for readiness and charged. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 65: The Backup System Controller
How Your Heart Pump Works 2 The Backup System Controller HeartMate II patients receive two System Controllers: one to actively use (running), and a reserve (backup) in case the running System Controller experiences a failure. The backup System Controller is identical to the running System Controller and is programmed with the same settings as the running System Controller.
Page 66 Sit or lie down (you may get dizzy if the pump briefly stops). Unlock the driveline safety tab on the running System Controller Figure 25 Figure 25 Unlock the Safety Tab on the Running System Controller HeartMate II Left Ventricular Assist System Patient Handbook...
Page 67 33 Black c. Move the black c. Disconnect the old, replaced connector’s connector’s power source System Controller from power. power from the running controller to source the backup System Controller. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 68 50. Do not use the old, replaced System Controller ever again. Contact your hospital contact to request a new backup System Controller and for instruc- tions on returning the old one. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 69: Powering The System
POWERING THE SYSTEM This section provides information about the various ways to power the HeartMate II Left Ventricular Assist System. Power Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - 59...
Page 71: Power Overview
See page 75. 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. See page 97. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 72: Using The Mobile Power Unit
A Mobile Power Unit with batteries inserted • A Mobile Power Unit AC power cord • A running System Controller Figure 27 The Mobile Power Unit Patient Cable Speakers Status Symbols AC Power Receptacle HeartMate II Left Ventricular Assist System Patient Handbook...
Page 73 You must always connect to the Mobile Power Unit when sleeping, or when there is a chance of sleep. You may not hear the system alarms when you are asleep, resulting in injury or death. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 74 • 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 II Left Ventricular Assist System Patient Handbook...
Page 75 104°F (40°C). Surface temperatures can approach 131°F (55°C). • Do not clean or service the Mobile Power Unit while it is plugged into an AC electrical outlet, or electrical shock may occur. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 76 • 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 77 Use a flathead screwdriver or coin to loosen the screw from the rear panel. The screw will remain in the screw hole to ensure it is not lost ( Figure 28 HeartMate II Left Ventricular Assist System Patient Handbook...
Page 78 If replacing the batteries, pull the ribbon to remove the depleted batteries out of the case. Place the Alkaline AA batteries in the battery compartment. Orient the batteries as shown on the orientation markings on the battery clip ( Figure HeartMate II Left Ventricular Assist System Patient Handbook...
Page 79 ( Figure 31 Figure 31 Tighten the Screw Dispose of or recycle the depleted batteries in compliance with all applicable local, state, and federal regulations. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 80 Plug the Mobile Power Unit into an AC electrical outlet that is dedicated to Mobile Power Unit use. Do not use an outlet that is controlled by a wall switch. Do not use portable, multiple outlet (power strip) adapters. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 81 If the green light still does not come on, the Mobile Power Unit may have a problem. Do not use it. Call your hospital contact. The power symbol ( ) is illuminated green when the Mobile Power IMPORTANT! Unit is powered and functioning properly. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 82 To connect the System Controller to the Mobile Power Unit, follow the steps below. Use care when connecting and disconnecting power cables. For more information, Guidelines for Power Cable Connectors on page 211. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 83 Place the batteries with their attached battery clips within easy reach. Unscrew and disconnect only the white System Controller power cable connector from the attached battery clip. Do not remove the black connector! HeartMate II Left Ventricular Assist System Patient Handbook...
Page 84 Figure 37 Figure 37 Push Together the Two Connectors Tighten the connector nut until secure ( ). Hand tighten only—do not Figure 38 use tools. Figure 38 Tighten the Connector Nut Connector Nut HeartMate II Left Ventricular Assist System Patient Handbook...
Page 85 Tighten the connector nut until secure. Hand tighten only—do not use tools. Both System Controller power cables are now connected to the Mobile Power Unit ( Figure 39 Figure 39 System Controller Power Cables Connected to Mobile Power Unit Patient Cable Connectors HeartMate II Left Ventricular Assist System Patient Handbook...
Page 86 Do not put the Mobile Power Unit into water or liquid. Never clean the Mobile Power Unit while it is providing power to your pump; switch to battery power first. Before cleaning the Mobile Power Unit, unplug all connections. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 87: Using Heartmate 14 Volt Lithium-Ion Batteries
(DC) batteries that are inserted into battery clips. The battery clips and attached batteries can be worn in holsters, one under each arm ( Figure 42 Figure 42 HeartMate II System on Battery Power HeartMate II Left Ventricular Assist System Patient Handbook...
Page 88 Use battery power when you want to be mobile and relatively active, for example, while shopping, running errands, or performing other activities outside the home. Use two HeartMate 14 Volt Lithium-Ion batteries to power the HeartMate II Left About the HeartMate 14 Volt Lithium-Ion Batteries Ventricular Assist System. See page 79.
Page 89 Powering the System 3 CAUTION ! • Use only the Thoratec-supplied Battery Charger to charge HeartMate 14 Volt Lithium-Ion batteries. Other battery chargers may damage HeartMate batteries. • After approximately 70 uses, HeartMate 14 Volt Lithium-Ion batteries may need to be recalibrated. The Battery Charger indicates when a battery needs recalibrated.
Page 90 • At least one System Controller power cable must be connected to a power source (Mobile Power Unit or two HeartMate 14 Volt Lithium-Ion batteries) at all times. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 91 (see a Battery’s Charge Level on page 83). Charging HeartMate 14 Volt Lithium-Ion Batteries on page 105 for instructions on charging HeartMate batteries. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 92 Power cable connectors on the System Controller connect to each battery clip ). In this way, battery power is supplied to the System Controller through Figure 44 the power cables. Figure 44 The System Controller Power Cable Attaches to the Battery Clip HeartMate II Left Ventricular Assist System Patient Handbook...
Page 93 Insert the battery into the battery clip. 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 II Left Ventricular Assist System Patient Handbook...
Page 94 Repeat Steps 2 and 3 for the second battery and attached battery clip. Put the batteries and battery clips in a clean, dry location for safe storage until next use. Place the batteries in the Battery Charger to recharge, if needed. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 95 Before starting this task, be sure you know how to do it safely. If you have questions, call your hospital contact. Gather equipment; place within easy reach. Locate a battery in one of the Battery Charger charging pockets. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 96 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 Table 4 14 Volt Lithium-Ion Battery On-Battery Power Gauge HeartMate II Left Ventricular Assist System Patient Handbook...
Page 97 Depending on how long a battery has been in storage, its power IMPORTANT! gauge may not work until after the battery is charged for the first time. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 98 To insert a fully-charged battery into a battery clip, line up the arrows on the battery and battery clip and then push the battery into the clip until the battery clicks into place ( Figure 48 Figure 48 Insert Battery into Battery Clip HeartMate II Left Ventricular Assist System Patient Handbook...
Page 99 ). Do not try to join together misaligned connectors, which Figure 50 can damage them. Figure 50 Carefully Match the Connectors Firmly push together the two connectors. Tighten the connector nut until secure. Hand tighten only—do not use tools. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 100 Both System Controller power cables are now connected to battery power Figure 51 Figure 51 System Controller Connected to Batteries Using HeartMate 14 Volt Lithium-Ion Batteries on page 75 for information on using HeartMate 14 Volt Lithium-Ion batteries to power the system. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 101 The red battery hazard alarm requires an immediate response. Immediately switch to a reliable alternate power source. When adequate power is supplied, the pump reverts to the previous mode and speed, and the red battery alarm clears. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 102 (count the number of lights that come on). Repeat Steps 3–5 for the second battery that is currently in use. Determine which battery has the least power. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 103 Return the clips and fully-charged batteries to holsters or carrying case. Make sure the Battery Charger is plugged in and turned on ("I"), and then place the low batteries in the pockets for recharging. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 104 360 cycles 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. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 105 Pull gently on the battery to confirm that the connection is tight. Repeat Steps 2–3 for the second battery and battery clip. Place the batteries with attached battery clips within easy reach. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 106 Place at least two additional fully-charged batteries in your travel case. Make sure you store the Mobile Power Unit patient cable so it will not get Note: damaged, dirty, or wet, and so it will not cause tripping or falling. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 107 If one battery has less charge, start with that battery and disconnect the connector from the battery; otherwise, disconnect the white connector first. Unscrew the white connector from its battery clip. The Power Cable Discon- nected alarm will come on. This is normal. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 108 Store the battery clips in a clean, dry location until next use. Charging Place the used batteries into the Battery Charger for charging (see HeartMate 14 Volt Lithium-Ion Batteries on page 105). HeartMate II Left Ventricular Assist System Patient Handbook...
Page 109: Using The Battery Charger
109). • Perform diagnostic testing on up to four HeartMate 14 Volt Lithium-Ion Viewing Battery Information on the Battery Charger batteries at a time (see on page 107). Figure 56 Battery Charger HeartMate II Left Ventricular Assist System Patient Handbook...
Page 110 • 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 111 Do not touch the metal contacts inside the Battery Charger when the charger is connected to AC power and turned on or you may get an electric shock. CAUTION ! • Use only the Thoratec-supplied Battery Charger to charge HeartMate 14 Volt Lithium-Ion batteries. Other battery chargers may damage HeartMate batteries. •...
Page 112 Carefully inspect the metal contacts inside the pockets. Dirt or objects covering the metal contacts inside the pockets may prevent proper battery charging, which can affect battery performance. Obtain the grey AC power cord from the product packaging. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 113 ( ). The charger beeps once and Figure 58 performs a self test for about 10 seconds. Figure 58 All Lights Turn On When the Charger is Turned On HeartMate II Left Ventricular Assist System Patient Handbook...
Page 114 210 for information on how to respond to advisory mes- sages. Figure 60 An Error Message on the Battery Charger If you will be traveling internationally, you will need a Thoratec IMPORTANT! power cord set that is compatible with the local voltage and that meets applicable national plug, rated voltage, rated current, and safety agency marks and specifications.
Page 115: Battery Charging Overview
The information is displayed on the charger display panel. Figure 61 Batteries Inserted in Battery Charger Pockets for Charging HeartMate II Left Ventricular Assist System Patient Handbook...
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 battery. Table 5 Description of Battery Charger Pocket Lights HeartMate II Left Ventricular Assist System Patient Handbook...
Page 117 Figure 63 The Battery Charger Can Charge Four Batteries at a Time Avoid covering or blocking the vents on the top of the charger during Note: use. Covering or blocking the vents may affect charger performance. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 118 Confirming a interrupted the charging cycle for some reason. See Pocket Fault on page 208 for information on how to handle red light conditions. Repeat Steps 2–4 for up to three more batteries. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 119: Viewing Battery Information On The Battery Charger
"50%" appears on the screen. In the example below, 90% of the battery’s power is available ( Figure 64 Figure 64 View Battery Charge Level Information on the Battery Charger HeartMate II Left Ventricular Assist System Patient Handbook...
Page 120 How much power the battery can potentially hold if fully charged (measured in mAh) Figure 65 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. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 121: Calibrating Heartmate 14 Volt Lithium-Ion Batteries
To calibrate the battery when prompted: • Within ten seconds of the start of the blinking yellow light, press and release the number button for this pocket. The charger begins calibrating the battery. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 122 12 hours. Under normal conditions, you should have four fully-charged batteries available so that you can exchange batteries twice during a 12-hour calibration cycle. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 123: Living With The Heartmate Ii
Sleeping- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 179 Traveling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 181 HeartMate II Left Ventricular Assist System Patient Handbook...
Page 124 4 Living with the HeartMate II HeartMate II Left Ventricular Assist System Patient Handbook...
Page 125: Keeping Your Home Safe
You are responsible for keeping your home safe after returning from the hospital. If you are not comfortable testing the electrical system, you can hire an electrician to do it. Talk with your hospital contact if you have questions or concerns about home safety. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 126: Staying Active And Safe
Washing Your Hands to Lower Infection OR THIS TASK YOU NEED • Clean, dry paper towels • Clean, running water • Liquid soap (liquid is better than bar soap that can have microbes growing on it) HeartMate II Left Ventricular Assist System Patient Handbook...
Page 127 (or could be dirty). Before refilling an empty soap dispenser, wash it first. This keeps the IMPORTANT! dispenser from becoming a breeding ground for microbes. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 128: Eating
An easy way to get calories and nutrition is by drinking healthy, high-calorie drinks and shakes. 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 II Left Ventricular Assist System Patient Handbook...
Page 129: Showering
Living with the HeartMate II 4 Showering Although the external components of the HeartMate II 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.
Page 130 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 below. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 131 120°F (49°C). Avoid contact on bare skin under these conditions because burns may occur. After opening the Shower Bag, wait for at least 4 minutes before handling the System Controller. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 132 • Do not place objects other than HeartMate II equipment in the wearable accessories. Placing objects other than HeartMate II equipment in a wearable accessory may damage the accessory.
Page 133 Figure 71 Slide the Belt Through the Loop on the Side of the Shower Bag Adjust the shoulder strap and belt so that the bag fits properly. Tighten or lengthen the straps until they are secure, but still comfortable. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 134 Unclip the top cover of the Shower Bag by squeezing the clip prongs together and sliding the clip out of the buckle (Figure 73). Figure 73 Open the Clip and Buckle on the Top of the Shower Bag HeartMate II Left Ventricular Assist System Patient Handbook...
Page 135 Unzip and open the cover of the water-resistant enclosure inside. Place the batteries and battery clips with attached power cables into the Shower Bag (Figure 75). Figure 75 Place Batteries and Clips in the Shower Bag HeartMate II Left Ventricular Assist System Patient Handbook...
Page 136 Figure 76 Slide the System Controller into the Pocket Prepare to close the cover by positioning the power cables inside the water resistant enclosure (Figure 77). Figure 77 Carefully Position the Power Cables in the Shower Bag HeartMate II Left Ventricular Assist System Patient Handbook...
Page 137 Figure 78 Carefully Close the Shower Bag so the Driveline Exits the Bag Through the Protective Red Tabs Close the lid over the zippered enclosure, carefully positioning the driveline down the side of the bag (Figure 79). Figure 79 The Driveline Exiting a Closed Shower Bag HeartMate II Left Ventricular Assist System Patient Handbook...
Page 138 Shower Bag from swinging away from your body if you bend over. 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 II Left Ventricular Assist System Patient Handbook...
Page 139 Apply a sterile dressing to the exit site, using an aseptic technique (see for the Driveline Exit Site on page 129). Use a clean, dry towel to dry the Shower Bag’s exterior and strap. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 140 Make sure the bag is completely dry before Cleaning and Caring for the Equipment using it again. See on page 220 for complete instructions on caring for all wearable accessories, including the Shower Bag. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 141: Caring For The Driveline Exit Site
See Do: Driveline and Cables on page 212. • Keep the driveline exit site as clean and dry as possible. A clean, dry exit site reduces the risk of infection. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 142 Drainage or bleeding Bad smell Feeling feverish, tired, or unwell If you notice any signs of infection, call your hospital contact right IMPORTANT! away. Do not wait! Early treatment makes a difference. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 143: Caring For The Driveline
Never put the driveline, System Controller, or any external equipment (such as the Mobile Power Unit, batteries, power cables, or battery clips) into water or liquid. Immersion in water or liquid may cause the pump to stop. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 144 The System Controller alarming when the driveline moves or when you change positions. High pulsatility index (PI) readings on the System Controller. Feeling pump vibrations. Fluid oozing from the external portion of the driveline. Device stoppage. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 145 • Check the driveline daily for signs of damage (cuts, holes, tears). Call your hospital contact right away if the driveline is damaged (or might be damaged). HeartMate II Left Ventricular Assist System Patient Handbook...
Page 146: Using The Stabilization Belt
Wear the Stabilization Belt (or other binder) at all times (Figure 82). Figure 82 The HeartMate Stabilization Belt and Lead Locks Stabilization Belt Lead Locks Figure 83 Wearing the Stabilization Belt HeartMate II Left Ventricular Assist System Patient Handbook...
Page 147 Allow the Stabilization Belt to air dry on its own. Never use heat to dry the belt. Drying the Stabilization Belt at high temperatures may cause premature breakdown of the Stabilization Belt material. Make sure the Stabilization Belt is completely dry before using it. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 148 Gently place the driveline over the center of the lead lock (Figure 84). Figure 84 Gently Place the Driveline Over the Lead Lock HeartMate II Left Ventricular Assist System Patient Handbook...
Page 149 Figure 85 Wrap Tab around Driveline and Insert it Through the Slot Attach the tab to the Stabilization Belt (Figure 86). If needed, adjust the tab for a snug fit. Figure 86 Attach the Tab to the Belt HeartMate II Left Ventricular Assist System Patient Handbook...
Page 150: Wearing And Carrying The System Controller
4 Living with the HeartMate II Wearing and Carrying the System Controller Several wear and carry accessories are available for the HeartMate II system. Figure 87 Accessories to Hold or Carry External Parts of the System Protection Bag See page 157.
Page 151 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. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 152 The System Controller has four attachment points (Figure 89)—one in each corner of the casing. The Neck Strap uses two attachment points for hanging the System Controller vertically or horizontally (Figure 90). Figure 89 Attachment Points on System Controller Attachment Attachment Points Points HeartMate II Left Ventricular Assist System Patient Handbook...
Page 153 Place the System Controller on a flat, stable surface. Make sure the System Controller power cables and driveline are not twisted (Figure 91). Figure 91 Make Sure the Power Cables and Driveline are Not Twisted HeartMate II Left Ventricular Assist System Patient Handbook...
Page 154 Hold the System Controller in one hand and give the Neck Strap a tug with the other hand. This helps to confirm that the buckle is securely connected to the System Controller (Figure 94). Figure 94 Give the Neck Strap a Tug HeartMate II Left Ventricular Assist System Patient Handbook...
Page 155 Place the Neck Strap and System Controller on a flat, stable surface. Unbuckle the Neck Strap tabs and remove the Neck Strap from the System Controller. Acceptable Operating Store the Neck Strap in a clean, dry location (see Conditions on page 219). HeartMate II Left Ventricular Assist System Patient Handbook...
Page 156 A quiet, well-lighted location where you can focus on the task • A running System Controller on Mobile Power Unit power • A Belt Attachment • Your own belt or the nylon belt that is provided HeartMate II Left Ventricular Assist System Patient Handbook...
Page 157 Slide either your belt or the nylon clip belt through the loop on the back of the Belt Attachment (Figure 97). Figure 97 Slide the Belt Through the Loop on the Belt Attachment Unclip the two-banded strap on the Belt Attachment. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 158 Figure 99 Place the Strap Between the Connectors Clip the two-banded strap into place (Figure 100). Make sure both prongs are fully engaged in the clip. Figure 100 Clip the Strap Into Place so the System Controller is Secure HeartMate II Left Ventricular Assist System Patient Handbook...
Page 159 Unclip the two-banded strap from the Belt Attachment. 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. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 160 The Consolidated Bag comes in one color (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. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 161 The driveline exits the bag through the protective red tabs on the side. Figure 102 Wearing the Consolidated Bag Consolidated Bag Version for Right- Sided Wearing Consolidated Bag Version for Left-Sided Wearing HeartMate II Left Ventricular Assist System Patient Handbook...
Page 162 The bag type (left or right) can be found on a tag inside the IMPORTANT! Consolidated Bag. Adjust the shoulder strap and belt so the bag fits you properly. Tighten or lengthen the strap and belt until they are secure but still comfortable. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 163 Make sure the System Controller power cables and driveline are not twisted (Figure 104). Figure 104 Make Sure the Power Cables and Driveline are Not Twisted Prepare the Consolidated Bag for use—unzip the double zippers and open the bag. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 164 System Controller power cable and the driveline connector. Fasten the clip to hold the System Controller in place (Figure 106). Figure 106 Stretch the Strap Over the System Controller and Between the Cables HeartMate II Left Ventricular Assist System Patient Handbook...
Page 165 Figure 107 Place Battery and Attached Battery Clip into Consolidated Bag Adjust the power cable so that it lays flat along the edge of the bag (Figure 108). Figure 108 Carefully Position the Power Cable Around the Edge of the Bag HeartMate II Left Ventricular Assist System Patient Handbook...
Page 166 Figure 109 Insert Second Battery Arrange the power cables so that they lay flat along the edge of the bag (Figure 110). Figure 110 Arrange the Cables Around the Inside of the Bag HeartMate II Left Ventricular Assist System Patient Handbook...
Page 167 Put the waist belt around your body and clip it into place. The belt stabilizes the bag and prevents it from moving. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 168 Transfer from battery power to Mobile Power Unit power (see Changing from Batteries to Mobile Power Unit Power on page 95). • Remove the components and transfer to another wearable accessory. Store the Consolidated Bag in a clean, dry location. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 169 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. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 170 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 II Left Ventricular Assist System Patient Handbook...
Page 171 Store the Protection Bag (with backup System Controller and cables inside) in the Travel Bag (Figure 114). Figure 114 Store the Protection Bag with Backup System Controller Inside the Travel Bag HeartMate II Left Ventricular Assist System Patient Handbook...
Page 172 4 Living with the HeartMate II Place the spare batteries inside the Travel Bag, on either side of the Protection Bag (Figure 115). Figure 115 Store the Batteries Inside the Travel Bag HeartMate II Left Ventricular Assist System Patient Handbook...
Page 173 HeartMate batteries (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 is adjustable to fit most users. Figure 116 Battery Holster HeartMate II Left Ventricular Assist System Patient Handbook...
Page 174 Figure 117 Belt Attachment Used with Battery Holster When you wear the Battery Holster, you can exchange low-charged batteries for Exchanging Low-Power fully-charged batteries without taking off the holster. See Batteries with Two Fully-Charged Batteries on page 167. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 175 Apply a strong epoxy glue to the cut-off ends of each strap to reduce fraying. Allow the glue to dry before wearing the holster. The straps can also be stitched together through the fabric to prevent the Note: fabric connector from moving and changing the fit. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 176 Gather equipment; place within easy reach. Make sure that the System Controller power cables and driveline are not twisted (Figure 118). Figure 118 Make Sure the Power Cables and Driveline are Not Twisted HeartMate II Left Ventricular Assist System Patient Handbook...
Page 177 Put on the Battery Holster with the inserted batteries/battery clips. Put on and secure the Belt Attachment around your waist. Adjust and tighten Putting on the Belt Attachment the belt as needed (see on page 144). HeartMate II Left Ventricular Assist System Patient Handbook...
Page 178 Slide the clip ends of the two-banded strap into the clip socket. The clip will click into place when securely fastened. Changing from Transfer from the Mobile Power Unit to battery power (see Mobile Power Unit Power to Batteries on page 93). HeartMate II Left Ventricular Assist System Patient Handbook...
Page 179 Battery Holster. Close the Battery Holster flap. Repeat Steps a–g for the second low battery. Charging HeartMate Recharge the low batteries in the Battery Charger (see 14 Volt Lithium-Ion Batteries on page 105). HeartMate II Left Ventricular Assist System Patient Handbook...
Page 180 Place the Belt Attachment and System Controller on a stable surface. If using your own belt: Unfasten the belt. Slide the Belt Attachment off the belt. Place the Belt Attachment and System Controller on a stable surface. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 181 Charging HeartMate Recharge the low batteries in the Battery Charger (see 14 Volt Lithium-Ion Batteries on page 105). Caring for the Equipment Store the holster in a clean, dry location (see page 217). HeartMate II Left Ventricular Assist System Patient Handbook...
Page 182 4 Living with the HeartMate II The Holster Vest Use the Holster Vest to hold the System Controller and two HeartMate batteries (with battery clips) during battery-powered operation (Figure 121). Figure 121 The Holster Vest HeartMate II Left Ventricular Assist System Patient Handbook...
Page 183 The Holster Vest is available in three sizes: small, medium, and large. When you wear the Holster Vest, you can exchange low-charged batteries for Exchanging Batteries While fully-charged batteries without taking off the vest. See Wearing the Holster Vest on page 176. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 184 (Figure 123). Figure 123 Insert the Vest Strap Through the Slot in the Top of the Holster Repeat Step 2 for the second holster. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 185 Gather equipment; place within easy reach. Make sure that the System Controller power cables and driveline are not twisted (Figure 124). Figure 124 Make Sure the Power Cables and Driveline are Not Twisted HeartMate II Left Ventricular Assist System Patient Handbook...
Page 186 Put on the Holster Vest with the attached batteries/battery clips. Adjust and tighten the straps as needed. If the chest strap is used, position it higher or lower on the vest as needed, so it is secure and comfortable. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 187 (Figure 127). Figure 127 Use VELCRO Tabs to Hold the Power Cables Put the belt through the VELCRO tabs to help secure the holsters in place. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 188 Remember ! Before starting this task, be sure you know how to do it safely. If you have questions, call your hospital contact. Obtain two fully-charged HeartMate batteries; place them within easy reach. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 189 Figure 128 Exchanging a Battery Repeat Steps a–e to exchange the second low battery. Charging HeartMate Recharge the low batteries in the Battery Charger (see 14 Volt Lithium-Ion Batteries on page 105). HeartMate II Left Ventricular Assist System Patient Handbook...
Page 190 Recharge the low batteries in the Battery Charger (see 14 Volt Lithium-Ion Batteries on page 105). Caring for the Equipment Store the Holster Vest in a clean, dry location ( page 217). HeartMate II Left Ventricular Assist System Patient Handbook...
Page 191: Sleeping
Between Mobile Power Unit and electrical outlet Check that the bedside flashlight has working batteries. Place backup equipment nearby: Backup System Controller Fully-charged HeartMate batteries (already in their clips) Make sure your emergency contact list is nearby. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 192 All backup equipment should also be nearby when sleeping, including the backup System Controller and fully-charged batteries (already in their clips). This way, in an emergency, everything you need is nearby. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 193: Traveling
Mobile Power Unit. WARNING ! For international travel, you must use Thoratec power cords that are compatible with the local voltage and that meet applicable national plug, rated voltage, rated current, and safety agency marks and specifications for both the Mobile Power Unit and Battery Charger.
Page 194 Some states have laws against letting patients drive if they have a history of fainting, dizziness, or cardiac arrest. Usually, you need to wait at least 6–8 weeks after surgery before being considered for driving privileges. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 195: Alarms And Troubleshooting
ALARMS AND TROUBLESHOOTING This section describes the primary alarms and troubleshooting of the HeartMate II Left Ventricular Assist System. System Controller Alarms - - - - - - - - - - - - - - - - - - - - - - - 185...
Page 197: System Controller Alarms
Alarms are listed in order of priority. Hazard alarms are listed first, followed by Advisories. See Table 7 and Table 8 on the following pages for a complete list of prioritized System Controller alarms. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 198 The timer on the screen counts up in seconds, indicating how long the alarm has been occurring. Figure 129 shows the alarm screen layout. Figure 129 Alarm Screen Alarm Message Duration Timer HeartMate II Left Ventricular Assist System Patient Handbook...
Page 199 A dot at the bottom of each screen provides navigational information about which screen is in view (see Figure 130). Figure 130 Sample Alarm History Screen Date and Time of Alarm Alarm Type Duration of Alarm Navigation Information HeartMate II Left Ventricular Assist System Patient Handbook...
Page 200 Press display button a THIRD time to display the fourth alarm. Press Press display button a FOURTH time to display the fifth alarm. Press Press display button a FIFTH time to display the sixth alarm. Table 6 Viewing Alarm History Screens HeartMate II Left Ventricular Assist System Patient Handbook...
Page 201 For this reason, these events also do not appear in alarm history. On-screen messages come in many different languages. Talk with your Note: hospital contact about selecting the language that is best for your needs. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 202 2. If alarm persists, call your hospital contact immediately. 5 min. For more information, see page 197. remaining Table 7 System Controller Hazard Alarms The Pump Running symbol ( ) is always lit green when the pump is IMPORTANT! running. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 203 Backup Battery not installed For more information, see page 203. Table 8 System Controller Advisory Alarms The Pump Running symbol ( ) is always lit green when the pump is IMPORTANT! running. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 204 • 2 minutes or until a new hazard alarm occurs. Alarm silence period: • To silence this alarm, press the silence alarm button( Table 9 Pump Off Alarm HeartMate II Left Ventricular Assist System Patient Handbook...
Page 205 • 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. Table 10 Driveline Disconnected Alarm HeartMate II Left Ventricular Assist System Patient Handbook...
Page 206 15 minutes when fully charged if the main power source is System Controller Backup Power disconnected or fails. See on page 51 for details about the 11 Volt Lithium-Ion backup battery inside the System Controller. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 207 The pump gradually slows to the low speed limit to save power in an effort to prevent the pump from stopping. When adequate power is supplied, the pump reverts to the previous speed and the red battery alarm clears. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 208 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( Table 12 Low Flow Alarm HeartMate II Left Ventricular Assist System Patient Handbook...
Page 209 • 2 minutes or until a new hazard alarm occurs. Alarm silence period: • To silence this alarm, press the silence alarm button( Table 13 Low Battery Power Alarm (< 5 minutes) HeartMate II Left Ventricular Assist System Patient Handbook...
Page 210 • 2 minutes or until a new hazard alarm occurs. Alarm silence period: • To silence this alarm, press the silence alarm button( Table 14 Power Cable Disconnected Alarm HeartMate II Left Ventricular Assist System Patient Handbook...
Page 211 • 5 minutes or until any new alarm occurs. Alarm silence period: • To silence this alarm, press the silence alarm button( Table 15 Low Battery Power Alarm (< 15 minutes) HeartMate II Left Ventricular Assist System Patient Handbook...
Page 212 Controller and is programmed with identical patient-specific settings. It should remain with you at all times for easy access in an emergency. For replacement Replacing the Running System Controller with a Backup Controller instructions, see on page 54. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 213 • 4 hours or until any new alarm occurs. Alarm silence period: • To silence this alarm, press the silence alarm button( Table 17 System Controller Backup Battery Fault Alarm HeartMate II Left Ventricular Assist System Patient Handbook...
Page 214 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( Table 18 Low Speed Alarm HeartMate II Left Ventricular Assist System Patient Handbook...
Page 215 • 4 hours or until any new alarm occurs. Alarm silence period: • To silence this alarm, press the silence alarm button( Table 19 System Controller Backup Battery Not Installed Alarm HeartMate II Left Ventricular Assist System Patient Handbook...
Page 216: Mobile Power Unit Alarms
Figure 131 Indicators on the Mobile Power Unit When the Mobile Power Unit is connected to the System Controller, the Note: Mobile Power Unit duplicates any active audio System Controller alarms. See Handling System Controller Alarms on page 185. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 217 Reconnect to the Mobile Power Unit, ensuring that the power cables are connected correctly—white-to-white and black-to-black. Call your hospital contact if reconnecting to the Mobile Power Unit does not resolve the alarm. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 218: Battery Charger Alarms
OR THIS TASK YOU NEED • A quiet, well-lighted location where you can focus on the task • An in-use Battery Charger • Up to 4 HeartMate 14 Volt Lithium-Ion batteries in the charging pockets HeartMate II Left Ventricular Assist System Patient Handbook...
Page 219 The alarm code is one letter followed by four numbers. Alarm codes related to batteries begin with the letter "B." Record the alarm code and save it for future reference. Remove the defective battery from use. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 220 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 Battery Note: Charger is replaced. You can continue to use the other pockets. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 221 Do not use a damaged or defective Battery Charger until it is repaired or Note: replaced. Until you have a safe and reliable way to recharge batteries, use the Mobile Power Unit to power your HeartMate system. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 222 BXXXX—Battery fault with alarm code SXXXX—Charger pocket (slot) fault with alarm code # = X—“X” equals the battery charge cycle count mAh = XXXX—Battery charge capacity in milliamp-hour Table 21 Battery Charger Display Panel Messages HeartMate II Left Ventricular Assist System Patient Handbook...
Page 223: Guidelines For Power Cable Connectors
• Never twist connectors or pull them apart at an angle. Figure 133 Carefully Align the Connectors Figure 134 Tighten the Connector Nut Connector Nut HeartMate II Left Ventricular Assist System Patient Handbook...
Page 224: 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. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 225 Alarms and Troubleshooting 5 CAUTION ! Do not twist, kink, or sharply bend the System Controller power cables. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 226 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. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 227 Do not connect a System Controller to both the Mobile Power Unit and the Power Module at the same time, or damage to the controller and injury to the patient may occur. First connect to HeartMate 14 Volt batteries. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 228 5 Alarms and Troubleshooting HeartMate II Left Ventricular Assist System Patient Handbook...
Page 229: Caring For The Equipment
CARING FOR THE EQUIPMENT This section provides information about how to care for the HeartMate II Left Ventricular Assist System and the wear and carry accessories. Acceptable Operating Conditions - - - - - - - - - - - - - - - - - - 219...
Page 231: Acceptable Operating Conditions
System Controller is not charged every six months, its charge level will diminish and there may not be sufficient power to support the pump if the backup System Controller is in use during a power emergency. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 232: Cleaning And Caring For The Equipment
IMPORTANT! cleaning. Disconnecting the driveline will make the pump stop. The driveline connector should be inspected only if the running System Controller is replaced (see The Backup System Controller on page 53). HeartMate II Left Ventricular Assist System Patient Handbook...
Page 233 Damage due to wear and fatigue of the driveline has occurred in both the externalized and implanted portions of the driveline. Damage to the redundant wires within the driveline may or may not be preceded by visible damage to the outer layer of the driveline. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 234 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 II Left Ventricular Assist System Patient Handbook...
Page 235 (not wet) cloth. You may use a mild detergent, if necessary. Allow the Mobile Power Unit to dry completely before use. Do not clean the Mobile Power Unit while it is powering the system. IMPORTANT! HeartMate II Left Ventricular Assist System Patient Handbook...
Page 236 Caring for the Battery Charger The Battery Charger requires little maintenance. However, it should be inspected routinely for the safest and best possible performance. For more information, see Safety Checklists on page 261. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 237 Stabilization Belts, you can wear one while the other is drying. Periodically inspect the Stabilization Belt for damage or wear. If it appears damaged or worn, do not use it. Contact your hospital contact for a replacement. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 238: 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 II Left Ventricular Assist System Patient Handbook...
Page 239: Frequently Asked Questions
FREQUENTLY ASKED QUESTIONS This section provided answers to commonly asked questions about the HeartMate II Left Ventricular Assist Device. Corporate Information - - - - - - - - - - - - - - - - - - - - - - - - 229...
Page 241: Corporate Information
No. Only use the HeartMate 14 Volt Lithium-Ion batteries that you got from the hospital at discharge. Other batteries will not power the HeartMate II 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 242 If the bandages covering the exit site get wet, change them right away. Use the aseptic technique that you learned from your hospital contact. Are there medications that will interfere with my pump? Consult your doctor before starting any new medications or dietary supplements. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 243: Showers And Exercise
Shower Bag. Can I exercise, play sports, or go to the gym? Many HeartMate II 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 244 Many new users worry about doing something that could stop the pump. Try not to worry. The HeartMate II 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 245: Handling Emergencies
HANDLING EMERGENCIES This section provides information to assist you in dealing with an emergency. Make sure you read and understand this information so you are IMPORTANT! prepared in case of an emergency. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 247: What Is An Emergency
Make sure you have completed the Emergency Contact List on page v and keep it available at all times. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 248 54). 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 II Left Ventricular Assist System Patient Handbook...
Page 249: Testing & Classification
TESTING & CLASSIFICATION This section provides information about safety testing and classification for the HeartMate II Left Ventricular Assist System. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 251: Safety Testing And Classification
Testing & Classification 9 Safety Testing and Classification The HeartMate II 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 252 9 Testing & Classification These standards require making the following declarations and stating the type and degree of protection for listed hazards. • UL 60601-1, 1st ed. 2006-04-26 • CAN/CSA-C22.2 No. 601.1-M90 (R2005) HeartMate II Left Ventricular Assist System Patient Handbook...
Page 253: Declaration Concerning General Safety Standards
Only when connected to System Controller. • Battery Charger–IPX0:Non-protected against ingress of water • HeartMate II Left Ventricular Assist Device Applied parts • System Controller Table 23 Declaration Concerning General Safety Standards HeartMate II Left Ventricular Assist System Patient Handbook...
Page 254 9 Testing & Classification For additional information on testing and classification for the HeartMate II Left HeartMate II Instructions for Use Ventricular Assist System, please see the . Your hospital contact can get a copy for you. CAUTION ! Use of equipment and supplies other than those specified in the manuals or sold...
Page 255: Declaration And Guidance For Electromagnetic Emissions
The HeartMate II Left Ventricular Assist System is intended for use in the electromagnetic environment specified below. The customer or the user of the HeartMate II Left Ventricular Assist System should assure that it is used in such an environment.
Page 256: Declaration And Guidance For Electromagnetic Immunity
The HeartMate II Left Ventricular Assist System is intended for use in the electromagnetic environment specified below. The customer or the user of the HeartMate II Left Ventricular Assist System should assure that it is used in such an environment.
Page 257 IEC 61000-4-8 or hospital environment. EN 61000-4-8 Table 25 Declaration and Guidance Concerning Electromagnetic Immunity for all HeartMate II Left Ventricular Assist System Equipment including Power Module/Mobile Power Unit and System Monitor HeartMate II Left Ventricular Assist System Patient Handbook...
Page 258 The HeartMate II Left Ventricular Assist Device, System Controller, and batteries are intended for use in the electromagnetic environment specified below. The customer or the user of the HeartMate II Left Ventricular Assist Device, System Controller, and batteries should assure that they are used in such an electromagnetic environment.
Page 259 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the HeartMate II Left Ventricular Assist System is used exceeds the applicable RF compliance level above, HeartMate II Left Ventricular Assist System should be observed to verify normal operation.
Page 260 9 Testing & Classification The HeartMate II Left Ventricular Assist System has been tested and found to comply with the limits for medical devices to IEC 60601-1-2:2007, Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and tests.
Page 261 Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Note 5: The HeartMate II Left Ventricular Assist System was tested to 56 V/m, per IEC-61000-4-3, in the wireless telephone bands between 825 to 960 MHz and 1.4 to 2.0 GHz.
Page 262: Declaration And Guidance For Electromagnetic Emissions For Heartmate Power Module
The HeartMate II Left Ventricular Assist System with Power Module is intended for use in the electromagnetic environment specified below. The customer or the user of the HeartMate II Left Ventricular Assist System should assure that it is used in such an environment.
Page 263: Declaration And Guidance For Electromagnetic Emissions For The Mobile Power Unit
The HeartMate II Left Ventricular Assist System with Mobile Power Unit is intended for use in the electromagnetic environment specified below. The customer or the user of the HeartMate II Left Ventricular Assist System should assure that it is used in such an environment.
Page 264: Declaration And Guidance For Electromagnetic Emissions For Battery Charger
Magnetic Field RE101 magnetic field emissions are very low and MIL-STD-461F are not likely to cause any interference in nearby electronic equipment. Table 30 Declaration and Guidance Concerning Electromagnetic Emissions for Battery Charger HeartMate II Left Ventricular Assist System Patient Handbook...
Page 265: Declaration And Guidance For Electromagnetic Immunity For The Battery Charger
3 A/m 30 A/m Magnetic Field in a typical commercial or hospital IEC 61000-4-8 environment. EN 61000-4-8 Table 31 Declaration and Guidance Concerning Electromagnetic Immunity for the Battery Charger HeartMate II Left Ventricular Assist System Patient Handbook...
Page 266 Battery Charger. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Table 32 Declaration and Guidance Concerning Electromagnetic Immunity for the Battery Charger HeartMate II Left Ventricular Assist System Patient Handbook...
Page 267 Testing & Classification 9 WARNING ! • Do not use equipment or supplies other than those specified or sold by Thoratec Corporation. The use of unauthorized replacement parts may result in increased emissions or decreased immunity of the HeartMate Left Ventricular Assist System.
Page 268: Declaration And Guidance For Electromagnetic Emissions
The HeartMate II 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 II Left Ventricular Assist System should assure that it is used in such an environment.
Page 269: Declaration And Guidance For Electromagnetic Immunity For Heartmate 14 Volt Lithium-Ion Batteries
The HeartMate II 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 II Left Ventricular Assist System with 14 Volt Lithium-Ion batteries should assure that it is used in such an environment.
Page 270 9 Testing & Classification The HeartMate II 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 II Left Ventricular Assist System with 14 Volt Lithium-Ion batteries should assure that it is used in such an electromagnetic environment.
Page 271 CW and Ovens 2.4 to 2.5 GHz Avionics Frequency Range Radiated RF Cat. R Radiated 100 MHz RTCA/DO-160 to 8 GHz G Section 20 Table 35 Declaration and Guidance Concerning Electromagnetic Immunity (Continued) HeartMate II Left Ventricular Assist System Patient Handbook...
Page 272 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the HeartMate II Left Ventricular Assist System with 14 Volt Lithium-Ion batteries is used exceeds the applicable RF compliance level above, the HeartMate II Left Ventricular Assist System with 14 Volt Lithium-Ion batteries should be observed to verify normal operation.
Page 273: Safety Checklists
As-Needed Safety Checklist- - - - - - - - - - - - - - - - - - - - - - 270 Clinic Visit Safety Checklist - - - - - - - - - - - - - - - - - - - - - - 271 HeartMate II Left Ventricular Assist System Patient Handbook...
Page 275: Daily Safety Checklist
(see on page 129). Inspect the driveline exit site for signs of infection, including redness, tenderness, swelling, discharge, or a foul odor. Use aseptic technique to touch or handle the exit site. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 276 Inspect the driveline and all cables for signs of damage, such as cracking, What Not fraying, wear, exposed wires, twists, sharp bends, or kinks (see To Do: Driveline and Cables on page 212). HeartMate II Left Ventricular Assist System Patient Handbook...
Page 277: Weekly Safety Checklist
Inspect the HeartMate Stabilization Belt 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 II Left Ventricular Assist System Patient Handbook...
Page 278: Monthly Safety Checklist
Do not attempt to clean or repair equipment on your own. If the Mobile Power Unit is going to be stored for over a month, remove the Mobile Power Unit batteries. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 279 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 II Left Ventricular Assist System Patient Handbook...
Page 280: 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 Inserting or Replacing the Mobile Power and call your hospital contact. (See Unit Batteries on page 65). HeartMate II Left Ventricular Assist System Patient Handbook...
Page 281: 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 282: As-Needed Safety Checklist
(not wet) cloth. You may use a mild detergent, if necessary. Do not immerse the charger in water or liquid. REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 283: Clinic Visit Safety Checklist
Patient Handbook Section 4). Review caring for the driveline exit site including cleansing, dressing, and Patient Handbook immobilizing the driveline ( Section 4). System Controller must be maintained and assessed for readiness. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 284 10 Safety Checklists HeartMate II Left Ventricular Assist System Patient Handbook...
Page 285: Survey
SURVEY This section includes a survey about this handbook. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 287 How satisfied are you with the quality of documentation that Thoratec provides? __ Very satisfied __ Satisfied __ Not satisfied The printed materials and media that Thoratec provides are available in the languages I need. __ Yes __ No HeartMate II Patient Handbook Topics covered in the meet my information needs.
Page 288 Phone ________________________ e-mail To share your feedback about this manual, mail or fax a copy of your completed sur- vey to: Marketing Communication Manager Thoratec Corporation 6035 Stoneridge Drive Pleasanton, CA 94588 HeartMate II Left Ventricular Assist System Patient Handbook...
Page 289: Glossary
Terms - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 280 HeartMate II Left Ventricular Assist System Patient Handbook...
Page 291: Abbreviations
Left Ventricular Assist Device LVAS Left Ventricular Assist System Low Molecular Weight ml/hr Milliliter per hour Magnetic Resonance Imaging Operating Room Pulsatility Index Partial Thromboplastin time Once daily Revolutions Per Minute Three times daily Volt HeartMate II Left Ventricular Assist System Patient Handbook...
Page 292: Terms
Controller must be recharged once every six months. Battery: A device that provides direct current (DC) power to the system. The HeartMate II Left Ventricular Assist System can be powered by two 14 Volt Lithium-Ion batteries. See Using HeartMate 14 Volt Lithium-Ion Batteries on page 75.
Page 293 Direct Current: Abbreviated DC. The type of electricity that comes from a battery. The HeartMate II system uses two 14 Volt Lithium-Ion batteries. Display Button: A button on the System Controller user interface. Press this button ( ) to bring up data on the user interface’s display screen (such as...
Page 294 Hazard alarms are indicated by a red light and continuous audio tone. HeartMate II Left Ventricular Assist System: Includes the pump and driveline, as well as the System Controller, power sources (Mobile Power Unit or batteries), and accessories. You may sometimes hear the term “LVAS,” which is short for Left Ventricular Assist System.
Page 295 ) on the System Controller. It lights when HeartMate II pump blood flow is critically low. Low Speed Limit: The lowest speed at which the HeartMate II pump can operate while maintaining patient stability. LPM: Short for liters per minute (lpm). Blood flow through the pump is measured in lpm.
Page 296 Power Saver Mode. Alarms cannot be silenced while in Power Saver Mode. See Power Saver Mode on page 92. Power Sources: Two power sources can power the HeartMate II Left Ventricular Assist System: 1) two wearable, rechargeable 14 Volt Lithium-Ion batteries worn in battery clips, or 2) the Mobile Power Unit that plugs into an AC electrical outlet.
Page 297 System Controller: The small computer that controls and checks system function. It connects the pump to the external power sources. It can be worn on a strap around the neck, on a belt, or in a carrying case. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 298 However, the white cable contains a data link that sends information to the Mobile Power Unit. Tethered Operation: Refers to using the HeartMate II Left Ventricular Assist System while connected to an electrical outlet via the Mobile Power Unit.
Page 299 HeartMate 14 Volt Lithium-Ion batteries providing power during battery-powered operation. Yellow Wrench Alarm: A yellow-colored symbol ( ) on the System Controller user interface that illuminates during alarm conditions that are important, but not immediately life-threatening. HeartMate II Left Ventricular Assist System Patient Handbook...
Page 301 System Controller backup battery fault disposal backup battery not installed advisory environmental requirements connect driveline estimating available charge connect power Power Saver Mode HeartMate II Left Ventricular Assist System Patient Handbook...
Page 302 197, 199 daily checklist low flow hazard alarm display button on System Controller low flow screen 192, 196 disposing of equipment low speed advisory alarm driveline low speed screen care cleaning HeartMate II Left Ventricular Assist System Patient Handbook...
Page 303 Mobile Power Unit replace power screen yellow diamond symbol replace System Controller yellow wrench symbol instructions System Monitor Run Mode for System Controller environmental requirements for operation safety checklists HeartMate II Left Ventricular Assist System Patient Handbook...
Page 304 Battery Holster Belt Attachment cleaning Consolidated Bag Holster Vest Protection Bag System Controller Neck Strap Travel Bag x-rays, using to determine driveline damage yellow diamond symbol yellow wrench symbol HeartMate II Left Ventricular Assist System Patient Handbook...
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Thoratec HeartMate II Patient Handbook

1 Introduction

2 How Your Heart Pump Works

3 Powering the System

4 Living with the Heartmate II

5 Alarms and Troubleshooting

6 Caring for the Equipment

7 Frequently Asked Questions

8 Handling Emergencies

9 Testing & Classification

10 Safety Checklists

11 Survey

12 Glossary

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Table of Contents