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Contents

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ENTRICULAR

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Introduction   -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  1-1

Preface -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  - 1-3
Understanding Warnings and Cautions  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  - 1-3
Overview -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  - 1-4

Indications  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -    1-8
Contraindications   -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -    1-8
Adverse Events -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -    1-9
Pre-Use Requirements-  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -    1-9

Equipment Overview -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  - 1-10
Principles of Operation-  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  - 1-14
Explanation of Parameters -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  - 1-16

2

System Operations  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  2-1

HeartMate III Left Ventricular Assist Device Overview  -  -  -  -  -  -  -  -  -  -  -  -  - 2-3
System Controller Overview  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  - 2-7
Backup System Controller Overview -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  - 2-41

3

Powering the System -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  3-1

Power Overview  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  - 3-3
Using the Power Module -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  - 3-5
Using the Mobile Power Unit -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  - 3-34
Using HeartMate 14 Volt Lithium-Ion Batteries -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  - 3-46
Switching Power Sources-  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  - 3-58
Battery Charger Overview -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  - 3-65
Charging HeartMate Batteries -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  - 3-72
Calibrating HeartMate Batteries  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  - 3-75
Checking Battery Power  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  - 3-77
Care and Maintenance of the Battery Charger   -  -  -  -  -  -  -  -  -  -  -  -  -  -  -  - 3-78

Summary of Contents for HeartMate III

Page 1: ...Instructions for Use ...

Page 2: ......

Page 3: ...Thoratec Corporation HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM Instructions for Use ...

Page 4: ...HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE ii ...

Page 5: ...Corporation continually strives to provide the highest quality of products for mechanical circulatory support Specifications may change without notice Thoratec and the Thoratec logo are registered trademarks and HeartMate III Full MagLev and HeartLine are trademarks of Thoratec Corporation Microsoft and Windows are registered trademarks of Microsoft Corporation CompactFlash is a registered tradema...

Page 6: ...HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE iv ...

Page 7: ...s 1 16 2 System Operations 2 1 HeartMate III Left Ventricular Assist Device Overview 2 3 System Controller Overview 2 7 Backup System Controller Overview 2 41 3 Powering the System 3 1 Power Overview 3 3 Using the Power Module 3 5 Using the Mobile Power Unit 3 34 Using HeartMate 14 Volt Lithium Ion Batteries 3 46 Switching Power Sources 3 58 Battery Charger Overview 3 65 Charging HeartMate Batteri...

Page 8: ...g the Sealed Outflow Graft 5 14 Preparing the Sealed Outflow Graft 5 15 Unpacking the System Controller 5 16 Unpacking the Modular Cable 5 17 Connecting and Initializing the Sterile System Controller 5 19 Preparing Operating and Priming the Pump 5 22 Preparing the Coring Knife 5 29 Implant Procedures 5 30 Postimplant Procedures 5 51 Device Explant 5 55 6 Patient Care and Management 6 1 Postoperati...

Page 9: ...the Charger to Check Battery or Charger Status 7 33 Guidelines for Power Cable Connectors 7 36 What Not to Do Driveline and Cables 7 37 8 Equipment Storage and Care 8 1 Storage and Transport 8 3 Cleaning and Maintenance 8 4 Product Disposal 8 8 A Technical Specifications A 1 B Safety Testing and Classification B 1 Testing and Classification HeartMate 14 Volt Lithium Ion Batteries B 24 C Symbols C ...

Page 10: ...Contents viii HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE ...

Page 11: ...ides an introduction to the HeartMate III Left Ventricular Assist System Preface 1 3 Understanding Warnings and Cautions 1 3 Overview 1 4 Indications 1 8 Contraindications 1 8 Adverse Events 1 9 Pre Use Requirements 1 9 Equipment Overview 1 10 Principles of Operation 1 14 Explanation of Parameters 1 16 ...

Page 12: ...1 Introduction 1 2 HeartMate III Left Ventricular Assist System Instructions for Use ...

Page 13: ...c Corporation regularly provides laboratory training and on site in service programs Understanding Warnings and Cautions In this manual warnings and cautions that are relevant to a specific procedure or piece of equipment appear at the start of each applicable section Warnings refer to actions or hazardous conditions that could cause serious injury or death if not avoided Ignoring a warning can ca...

Page 14: ...two configurations Line power may be utilized through the Power Module or the Mobile Power Unit to run the LVAD indefinitely This is convenient for sedentary or sleeping periods Whenever the Power Module is used a System Monitor may also be used as a means of view ing operating conditions changing operating parameters and manipulating stored data Portable Battery power may be utilized for limited ...

Page 15: ...orax of patients affected with advanced heart failure The LVAD contains the Inflow Cannula a Motor a Pump Chamber a Rotor an Outflow Graft and a Pump Cable Figure 1 2 Figure 1 2 Left Ventricular Assist Device Components 2 1 8 7 6 5 3 4 1 Pump Cable 2 Outflow Graft with Bend Relief 3 Inflow Cannula 4 Rotor Magnet 5 Pump Chamber 6 Rotor 7 Motor 8 Slide Lock ...

Page 16: ... a Coring Tool is used to resect a plug of myocardium at the left ventricular apex This allows insertion of the Inflow Cannula into the left ventricle An Apical Cuff is sewn to the epicardium and a Slide Lock is used to secure the Inflow Cannula and establish hemostasis The Outflow Graft assembly consists of a sealed woven polyester graft and the hardware necessary to attach the graft to the Pump ...

Page 17: ...caregivers must be trained on system operation and safety before use All users including clinicians patients and caregivers must be trained on any HeartMate III power accessories Power Module Mobile Power Unit Battery Charger or HeartMate 14 Volt Lithium Ion batteries before use Do not use the HeartMate III Left Ventricular Assist Device in pregnant women or in women likely to become pregnant A gr...

Page 18: ...settings should be conducted under the direction of the prescribing physician Authorized Personnel only Do not try to repair any of the HeartMate III system components If components need service contact the appropriate personnel Notify the appropriate personnel if there is a change in how the Pump works sounds or feels Counsel the patient to avoid contact sports and jumping activities while implan...

Page 19: ...molysis Pre Use Requirements A thorough understanding of the technical principles clinical applications and risks associated with left ventricular support is required before using the HeartMate III Left Ventricular Assist System It is suggested that patients possess a minimum 5th grade educational level and shall be versed in basic computer literacy that is Microsoft Windows and Office software Th...

Page 20: ...oller uses lights sounds and on screen messages to communicate with users about operating status and alarm conditions 14 Volt Lithium Ion Batteries and 14 Volt Battery Clips Two HeartMate 14 Volt Lithium Ion batteries power the system during battery powered operation such as when AC electricity is not wanted or unavailable The batteries are used in pairs and are inserted into a 14 Volt battery cli...

Page 21: ...itoring using the System Monitor The Mobile Power Unit is used when the patient is indoors stationary or sleeping The System Controller and the Mobile Power Unit are connected through the Mobile Power Unit patient cable The cable transfers power from the Mobile Power Unit to the System Controller System Monitor The use of the System Monitor during Left Ventricular Assist Device implantation is req...

Page 22: ...I Implant Kit Also available separately Table 1 2 Components and Equipment for Implant Components Required for Implantation and ICU Transfer Primary Backup HeartMate III Implant Kit Required Required System Controller with 11 Volt Lithium Ion Backup Battery Required Required Power Module with patient cable Required Required System Monitor Required Required One set of 4 rechargeable HeartMate 14 Vo...

Page 23: ...III Left Ventricular Assist Device Required n a System Controller with 11 Volt Lithium Ion backup battery Required Required Mobile Power Unit Required Not Required One set of 4 rechargeable HeartMate 14 Volt Lithium Ion batteries Required Required One set of 2 HeartMate 14 Volt battery clips Required Not Required Battery Charger Required Not Required One set of wear and carry accessories including...

Page 24: ...ference between aortic and left ventricular pressure and systemic vascular resistance This relationship can be characterized at any Rotor speed and the family of curves derived in steady state at different speeds is commonly termed H Q curves or the pressure head H volume flow rate Q relationship Figure 1 3 shows HeartMate III H Q curves Figure 1 3 Pressure Head Flow H Q Relationship Similarly the...

Page 25: ...rinsic limit somewhat above 9000rpm The system accordingly precludes setting the speed above 9000rpm Conversely if the LVAD speed is set too low support for the failing heart may be insufficient The HeartMate III LVAS uses the same Low Speed Limit mentioned previously to limit how low the speed may be set This is to avoid profound retrograde flow aorto ventricular shunt The Low Speed Limit can be ...

Page 26: ...g as PI events are detected Large changes in speed may indicate an abnormal condition that should be evaluated for cause Power Device power is a direct measurement of Pump motor voltage and current Changes in Pump speed flow or physiological demand can affect Pump power Gradual power increases over hours or days may signal thrombus deposits inside the Pump or aortic insufficiency Gradual power dec...

Page 27: ...r pulsatility that is the Pump is providing less support to the left ventricle Lower values indicate less ventricular filling and lower pulsatility that is the Pump is providing greater support and further unloading the ventricle PI values should be routinely monitored and should not vary significantly during resting conditions Under otherwise stable conditions a significant drop in value may indi...

Page 28: ...1 Introduction 1 18 HeartMate III Left Ventricular Assist System Instructions for Use ...

Page 29: ...for Use 2 1 SYSTEM OPERATIONS This section describes the primary system operations of the HeartMate III Left Ventricular Assist System HeartMate III Left Ventricular Assist Device Overview 2 3 System Controller Overview 2 7 Backup System Controller Overview 2 41 ...

Page 30: ...2 System Operations 2 2 HeartMate III Left Ventricular Assist System Instructions for Use ...

Page 31: ...ction The LVAD uses a rotary blood pump to generate flow and assist the left ventricle It is a centrifugally configured device so that the paths of the entering and exiting flow stream are perpendicular to the Pump s axis The device has only one moving part the Rotor assembly The Rotor assembly is fully that is actively magnetically levitated within the flow stream The Pump is driven by an externa...

Page 32: ...r Assist Device is implanted in the chest Figure 2 2 For more information refer to Implant Procedures on page 5 30 Figure 2 2 HeartMate III Implant Configuration The HeartMate III LVAD is part of the Left Ventricular Assist System Figure 2 3 Figure 2 3 HeartMate III LVAS During Battery Powered Operation 1 Outflow Graft 2 Inflow Cannula 2 1 ...

Page 33: ...nds to the textured material and anchors the external surface of the Driveline to the surrounding tissue After emerging from the body the Driveline has a Modular Connector that joins the Pump Cable to the Modular Cable The Modular Cable then has an electric connector that attaches to the System Controller Experience with other left ventricular assist devices has shown that wear and fatigue of the ...

Page 34: ...damaged internal to the patient s body the Pump should be replaced as soon as possible If It has been determined that the damage has been detected in the Modular Cable it can be replaced Refer to Replacing the Modular Cable on page 2 51 for the procedure for exchanging the Modular Cable Pump Motor Power The Left Ventricular Assist Device Motor is powered through the System Controller by one of thr...

Page 35: ...from the Power Module the Mobile Power Unit Lithium Ion Batteries or its own integrated emergency backup supply down to the LVAD via the Driveline The System Controller constantly monitors system performance through communication with the implanted LVAD and System Controller internal measurements It alerts the user to any alarm conditions by activating membrane panel LEDs and integrated audio annu...

Page 36: ...wer and communication lines to the Driveline This not only provides for a robust continuous operation of the implanted Pump in the event of a fault situation but also alerts the user to possible Driveline degradation The System Controller is the chief decision making component of the system It instructs the Pump at which speed to operate in any of the following ways By passing a command sent by th...

Page 37: ...ce Power Module Mobile Power Unit or 2 HeartMate 14 Volt Lithium Ion Batteries to the System Controller 2 User Interface User Interface provides buttons lights and a screen where system data alarms and user instructions appear 3 Backup Battery not shown Backup battery located inside the System Controller powers the Pump for at least 15 minutes during a power loss emergency 4 System Controller Driv...

Page 38: ...section provides a description of the two power cables on the System Controller one white and one black that connect the System Controller to the Power Module the Mobile Power Unit or two 14 Volt Lithium Ion batteries Performing a System Controller Self Test This section provides instructions for the self test System Controller Battery Power Gauge This section provides a description of how to read...

Page 39: ...p may stop If a HeartMate III patient is approved for showering he or she must always use the Shower Bag during every shower The Shower Bag protects external system components from water or moisture The 11 Volt Lithium Ion backup battery should be used only for temporary support during a power loss emergency The 11 Volt Lithium Ion backup battery inside the HeartMate III System Controller provides...

Page 40: ...l damage is not visible Damage to the Driveline or cables could cause the Left Ventricular Assist Device to stop If the Driveline or cables become twisted kinked or bent carefully unravel and straighten The 11 Volt Lithium Ion backup battery inside the backup System Controller must be charged at least once every six months Failure to charge the 11 Volt Lithium Ion backup battery inside the backup ...

Page 41: ...s crucial requirement The System Controller uses lights sounds and on screen messages to communicate with users about system operation HeartMate III patients with sight or hearing impairment may need extra help using the System Controller Do not place the System Controller on bare skin for an extended time The System Controller surface temperature can become uncomfortably warm especially when the ...

Page 42: ...ed on how to interpret and use the user interface prior to discharge Refer to Educating and Training Patients Families and Caregivers on page 6 12 For situations that require attention and depending on the urgency the System Controller provides one of two types of alarms hazard and advisory Hazard alarms occur for conditions that are potentially life threatening for the patient and require immedia...

Page 43: ...troller detects a mechanical electrical or software issue with the system This is an Advisory alarm When the yellow wrench illuminates check the screen for troubleshooting instructions Red Heart Alarm The red heart symbol illuminates when the System Controller detects a problem that could cause serious injury or death This is a Hazard alarm When the red heart illuminates check the screen for instr...

Page 44: ...wer remaining The more green bars that are illuminated the more power remaining Yellow diamond less than 15 minutes of battery power remain Appearance of this symbol indicates an Advisory alarm If the yellow diamond comes on promptly replace the low batteries with two fully charged batteries or switch to the Power Module or the Mobile Power Unit Do this as soon as possible IMPORTANT The battery po...

Page 45: ...ence Alarm Button The silence alarm button is used for the following Silencing an active alarm Press and release the Silence Alarm button to silence an active alarm on the System Controller How long it is silenced depends on the alarm Refer to System Controller Alarms on page 7 3 The LCD screen on the System Controller displays the audio alarm silence symbol IMPORTANT Using the Silence Alarm butto...

Page 46: ...ease the Display button Each push of the Display button brings up a new screen Each screen illuminates for 15 seconds before it goes black unless another button is pushed The screens are always displayed in the same order starting with the first Speed screen A dot at the bottom of each screen provides navigational information about which of the five screens is in view Table 2 4 shows the display s...

Page 47: ...up battery is located inside the System Controller and used to temporarily run the Pump during a power emergency The System Controller s backup battery has three charge status states Charged ready for use Charging actively charging Fault there is a fault or problem with the backup battery that could affect its reliability Press Press display button SIX times A blank screen indicates the screen is ...

Page 48: ...ediately alarms The Driveline is initially connected to the patient s System Controller during the procedure to implant the LVAD The same System Controller remains in use unless it requires replacement for clinical or technical reasons Refer to Backup System Controller Overview on page 2 41 It is impossible to connect or disconnect the Driveline without first rotating the Safety Lock on the back o...

Page 49: ...ntroller TO CONNECT THE DRIVELINE TO THE SYSTEM CONTROLLER 1 Orient the System Controller so the display is facing down 2 Rotate the Safety Lock to the unlocked position Figure 2 10 Figure 2 10 Unlocking the Safety Lock 3 Align the BLACK arrow alignment mark on the Driveline Cable Connector with the WHITE arrow on the System Controller socket Figure 2 11 Figure 2 11 Aligning the Arrows ...

Page 50: ... Safety Lock cannot move to the locked position unless the Driveline is fully and properly inserted 6 Move the Safety Lock to the locked position so that it covers the red button IMPORTANT If the safety tab does not fully cover the red button the Driveline is not connected Disconnect and reconnect the Driveline 7 Gently tug on the Modular Cable to check the connection Do not pull on or bend the Dr...

Page 51: ...n Figure 2 13 Figure 2 13 Unlocking the Safety Lock 3 Complete the following steps a Firmly press the red button under the Safety Lock while pulling the System Controller Driveline Connector from the socket b Grasp the bend relief of the Modular Cable while removing it Do not pull on or bend the System Controller Driveline Connector Figure 2 14 Figure 2 14 Removing the Driveline WARNING Failure to...

Page 52: ...ient cable and the Mobile Power Unit patient cable connectors are color coded Always connect black to black and white to white Both System Controller power cables provide equal power However the cable with the white connector transmits signals between the System Controller and System Monitor Refer to System Monitor Setup on page 4 5 The data link does not work without a white to white connection W...

Page 53: ...to the System Controller Refer to Using the Mobile Power Unit on page 3 34 for details Two HeartMate 14 Volt Lithium Ion batteries HeartMate batteries are used to power the system during battery powered operation when AC electricity is not wanted or is unavailable Batteries are used in pairs Each battery is inserted into a 14 Volt battery clip The clips transfer battery power to the System Control...

Page 54: ...for the System Controller During the self test the Pump Set Speed will not be changed The System Controller self test is a loud and bright function All of the audible and visual indicators should come on and the words Self Test should appear on the screen Figure 2 17 Figure 2 17 User Interface During System Controller Self Test Perform the self test at least once a day on the running System Contro...

Page 55: ... a loud steady tone there is a problem with the System Controller Do not use a System Controller that fails its self test 4 If the System Controller fails the self test complete the following steps a Replace the System Controller with the backup System Controller b Contact Thoratec for a new backup System Controller IMPORTANT If an alarm occurs during a self test the self test terminates and the a...

Page 56: ... number of green bars indicates the power remaining The more green bars that are illuminated the more power remaining To activate the battery power gauge press and release the Battery button on the user interface Figure 2 18 Figure 2 18 Battery Power Gauge Showing Full Charge IMPORTANT The battery power gauge does not show the charge status of the System Controller s backup battery the battery ins...

Page 57: ... For more information refer to Checking Battery Charge Status on page 3 50 Power Module Power Mobile Power Unit Power 4 green bars 75 100 of battery power remains 3 green bars 50 75 of battery power remains 2 green bars 25 50 of battery power remains 1 green bar less than 25 of battery power remains 4 green bars Normal Power Module operation 3 green bars Running on the Power Module backup battery ...

Page 58: ...yellow diamond or the red battery illuminate immediately replace the depleted batteries with a fully charged pair of batteries or switch to the Power Module or Mobile Power Unit Refer to Switching from Battery Power to the Power Module on page 3 61 or Connecting to the Mobile Power Unit on page 3 42 Yellow diamond Less than 15 minutes of combined battery power remain This is an Advisory alarm Red ...

Page 59: ...r Figure 2 19 Figure 2 19 System Controller in Run Mode While on Battery Power left and the Power Module right In Run Mode the Pump Running symbol is illuminated green and the System Controller Connects to a power source the Power Module the Mobile Power Unit or two HeartMate 14 Volt Lithium Ion batteries Connects to the Left Ventricular Assist Device via the Driveline Sends power to the Pump via ...

Page 60: ...the running System Controller In Sleep Mode the Pump Running symbol is off black and the backup System Controller is Disconnected from an external power source and powered off Disconnected from the Driveline Not displaying operating alarm data on the information display screen Not responding to user interface button pushes Not charging the 11 Volt Lithium Ion backup battery inside the System Contr...

Page 61: ...Module Mobile Power Unit or two HeartMate 14 Volt Lithium Ion batteries Connecting the System Controller to power and putting it into Charge Mode allows its 11 Volt Lithium Ion backup battery to charge A fully depleted 11 Volt Lithium Ion backup battery takes up to three hours to charge In Charge Mode the Pump Running symbol is off black and the backup System Controller is Charging the 11 Volt Lit...

Page 62: ...batteries 2 Connect the Driveline to the System Controller Refer to Connecting the Driveline to the System Controller on page 2 21 The Pump Running symbol is illuminated green and the System Controller is in Run Mode TO SWITCH FROM CHARGE MODE TO RUN MODE This procedure assumes that the System Controller is not in use but is connected to a power source and is in Charge Mode Connect the Driveline t...

Page 63: ...he words Charging Complete appear 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 TO SWITCH FROM RUN MODE TO SLEEP MODE 1 Disconnect the Driveline from the System Controller 2 Press and release the Silence Alarm button to silence the Driveline Disc...

Page 64: ...argeable 11 Volt Lithium Ion backup battery recharges automatically any time the running System Controller is connected to a power source It takes up to three hours to charge a fully depleted 11 Volt Lithium Ion backup battery Although rechargeable the backup battery has a limited lifespan The lifespan of a backup battery is 36 months from manufacture date Therefore it may be necessary to install ...

Page 65: ...hium Ion backup battery should be considered when less than 6 months remain before the mandatory replacement date FOR THIS TASK YOU NEED 1 replacement 11 Volt Lithium Ion backup battery obtained from Thoratec Corporation 1 lever to remove the screw cover of the battery compartment included with the replacement 11 Volt Lithium Ion backup battery 1 screwdriver to loosen the four battery cover screws...

Page 66: ...battery compartment Figure 2 26 Figure 2 26 Using the Screwdriver to Loosen the Screws 5 Remove the battery compartment cover 6 Remove the current 11 Volt Lithium Ion battery from the battery compartment as follows a Grasp the end of the ribbon cable that is attached to the current battery b Gently remove the ribbon cable from the battery socket Figure 2 27 Figure 2 27 Removing the Ribbon Cable Fr...

Page 67: ... is charging AND The backup battery installation graphic no longer appears on the information display screen 11 Place the backup battery and attached ribbon cable inside the battery compartment 12 Place the cover over the battery compartment 13 Use the provided screwdriver to tighten the four screws on the cover Figure 2 28 Figure 2 28 Tightening the Screws 14 Replace the screw cover IMPORTANT A n...

Page 68: ...m Controller s 11 Volt Lithium Ion backup battery IMPORTANT Be aware that installing an 11 Volt Lithium Ion backup battery may prompt a System Controller Clock Not Set advisory alarm on the System Monitor Complete the following steps to resolve a System Controller Clock Not Set advisory alarm 1 Use the System Monitor to reset the System Controller clock Refer to Date and Time on page 4 40 2 Ensure...

Page 69: ...roller If a failure occurs on the running System Controller it may need to be replaced with the backup System Controller For this reason and in case of an emergency the backup System Controller must remain with the patient at all times Figure 2 29 Figure 2 29 System Controller States IMPORTANT To replace the running System Controller with the backup System Controller refer to Replacing the Current...

Page 70: ...connected to the Pump the operating parameters are transferred from the Pump to the System Controller FOR THIS TASK YOU NEED 1 new and packaged System Controller complete with 11 Volt Lithium Ion backup battery and Patient Handbook 1 working Power Module with patient cable and AC power cord connected 1 System Monitor installed on Power Module 1 System Monitor data cable 1 functioning and grounded ...

Page 71: ...e 2 31 For more information refer to System Controller Language on page 4 42 5 Install the 11 Volt backup battery into the System Controller Figure 2 32 For more information refer to Installing the Backup Battery on page 5 52 Figure 2 32 Installing the Backup Battery 6 Disconnect power from the System Controller Note The System Monitor will have the PUMP OFF LOW FLOW and Driveline Disconnected ala...

Page 72: ...rged every six months The backup battery must be awakened connected to power and put into Charge Mode Connecting the backup System Controller to power charges its internal 11 Volt Lithium Ion backup battery While the backup System Controller is in Charge Mode a self test should be performed FOR THIS TASK YOU NEED 1 backup System Controller 1 power source Power Module Mobile Power Unit or two Heart...

Page 73: ...e backup System Controller 3 Press and hold the Battery button for five seconds Figure 2 36 For more information refer to Backup System Controller Overview on page 2 41 Note A self test can only be performed when power is connected to the System Controller Figure 2 36 System Controller Self Test 4 Disconnect power from the backup System Controller This will put the backup System Controller back in...

Page 74: ...ent understands the need for having a caregiver present during System Controller exchange and that all labeling instructions are followed This includes calling the hospital contact if instructed IMPORTANT The ability to successfully replace a System Controller may be affected by several factors such as native cardiac output cognitive function and so on Any of these may change over the course of LV...

Page 75: ...ler so the display is facing down b Rotate the Safety Lock to the unlocked position Figure 2 38 Figure 2 38 Unlocking the Safety Lock c Firmly press the red button under the Safety Lock while pulling the Controller Driveline Connector from the socket d Grasp the bend relief of the Driveline while removing it Do not pull on or bend the Controller Driveline Connector Figure 2 39 Figure 2 39 Removing...

Page 76: ...ly and properly inserted in the socket if Pump Set Speed is set above 4000 rpm Note The Safety Lock cannot move to the locked position unless the Driveline is fully and properly inserted 6 Move the Safety Lock to the locked position so that it covers the red button Figure 2 41 Figure 2 41 Closing the Safety Lock 7 Complete the following steps a Disconnect the Black Power connection from the previo...

Page 77: ...ing steps to power the replacement System Controller a Connect both the White and Black Power connections b Fully secure both the white and black nuts until tight 4 Complete the following steps to disconnect the Driveline from the current System Controller a Orient the System Controller so the display is facing down b Rotate the Safety Lock to the unlocked position Figure 2 42 Figure 2 42 Unlockin...

Page 78: ...rt running when the cable is fully and properly inserted in the socket if Pump Set Speed is set above 4 000 rpm Note The Safety Lock cannot move to the locked position unless the Driveline is fully and properly inserted 6 Move the Safety Lock to the locked position so that it covers the red button Figure 2 45 Figure 2 45 Closing the Safety Lock 7 Complete the following steps a Disconnect the Black...

Page 79: ...e System Controller will not enter Sleep Mode Replacing the Modular Cable One segment of the Driveline includes the Modular Cable If the Modular Cable needs to be replaced due to damage or fatigue it can be accomplished in two ways Option 1 Replace the current Modular Cable with both a NEW Modular Cable and replacement System Controller Option 2 Replace the current Modular Cable with a NEW Modular...

Page 80: ... to the replacement System Controller a Align the BLACK arrow on the Driveline Cable Connector with the WHITE arrow on the System Controller socket Figure 2 46 Figure 2 46 Aligning the Arrows b Insert the Driveline Cable Connector into the socket and press firmly until it snaps into place Note The Safety Lock cannot move to the locked position unless the Driveline is fully and properly inserted 5 ...

Page 81: ... Pump Cable a Rotate the locking nut of the in line connector Figure 2 48 b Listen for a clicking sound as the locking nut is rotated The clicking sound is normal When the clicking sound has stopped and the locking nut spins freely the locking nut has been unlocked Figure 2 48 Rotating the Locking Nut c Pull the connectors apart Figure 2 49 Figure 2 49 Pulling the Connectors Apart ...

Page 82: ... white triangles b Push the connectors firmly together Figure 2 50 Figure 2 50 Aligning the White Triangles c Rotate the locking nut of the Modular In Line connector d Wait for the clicking sound to stop and ensure that the yellow line is hidden by the locking nut Figure 2 51 Figure 2 51 Rotating the Locking Nut 8 Disconnect power and the Modular Cable from the original System Controller 9 Put the...

Page 83: ...rrent Modular Cable from the System Controller a Orient the System Controller so the display is facing down b Rotate the Safety Lock to the unlocked position Figure 2 52 Figure 2 52 Unlocking the Safety Lock c Unlock the Locking Nut on the currently connected Modular Cable from the Pump Cable by rotating the locking nut of the in line connector Figure 2 53 d Listen for a clicking sound as the lock...

Page 84: ...e Connector Figure 2 54 Figure 2 54 Removing the Driveline 4 Complete the following steps to connect the replacement Modular Cable to the System Controller a Align the BLACK arrow on the Driveline Cable Connector with the WHITE arrow on the System Controller socket Figure 2 55 Figure 2 55 Aligning the Arrows b Insert the Driveline Cable Connector into the socket and press firmly until it snaps int...

Page 85: ...losing the Safety Lock 6 Pull apart the Modular In line Connector Figure 2 57 Figure 2 57 Pulling the Connectors Apart 7 Complete the following steps to connect the replacement Modular Cable to the Pump Cable which has already been connected to the replacement System Controller a Align the white triangles b Push the connectors firmly together Figure 2 58 Figure 2 58 Aligning the White Triangles ...

Page 86: ...tricular Assist System Instructions for Use 8 Rotate the locking nut of the Modular In Line connector Figure 2 59 9 Wait for the clicking sound to stop and ensure that the yellow line is hidden by the locking nut Figure 2 59 Rotating the Locking Nut ...

Page 87: ...te III Left Ventricular Assist System Power Overview 3 3 Using the Power Module 3 5 Using the Mobile Power Unit 3 34 Using HeartMate 14 Volt Lithium Ion Batteries 3 46 Switching Power Sources 3 58 Battery Charger Overview 3 65 Charging HeartMate Batteries 3 72 Calibrating HeartMate Batteries 3 75 Checking Battery Power 3 77 Care and Maintenance of the Battery Charger 3 78 ...

Page 88: ...3 Powering the System 3 2 HeartMate III Left Ventricular Assist System Instructions for Use ...

Page 89: ...le are connected through the Power Module patient cable The cable transfers power from the Power Module to the System Controller Mobile Power Unit The Mobile Power Unit is for home or clinical use when the patient does not require monitoring using the System Monitor The Mobile Power Unit is used when the patient is indoors stationary or sleeping The System Controller and the Mobile Power Unit are ...

Page 90: ...tery clip The clips transfer battery power to the System Controller with two power cables one for each clip Without battery clips the batteries cannot transfer power to the system When fully charged a pair of new HeartMate 14 Volt Lithium Ion batteries can power the system for up to 17 hours depending on the activity level of the patient Figure 3 2 HeartMate 14 Volt Lithium Ion Batteries The Batte...

Page 91: ...when it is connected to the Power Module Connects the System Monitor to the System Controller for monitoring purposes Echoes System Controller alarms Figure 3 4 Power Module Required Components The following components are required for connecting the Power Module to the System Controller HeartMate Power Module with an installed Power Module backup battery Power Module patient cable Power Module po...

Page 92: ...ides approximately 30 minutes of backup power to the system during a power emergency The Power Module ships with the backup battery disconnected The battery must be connected prior to initial use If the Power Module backup battery is not connected the backup power source does not work Do not disconnect the Power Module patient cable from the Power Module when troubleshooting for a Not Receiving Da...

Page 93: ... is detected switch to battery power and Re orient or move the affected device or devices Increase the distance between the Power Module and or the Mobile Power Unit and the affected device or devices Connect affected device or devices to an electrical outlet different from the outlet used to power the Power Module and or the Mobile Power Unit Do not use equipment or supplies other than those spec...

Page 94: ...em If the System Monitor is mounted on top of the Power Module do not attempt to lift or carry the two components by using the System Monitor handle Doing so may damage the Power Module and or System Monitor When connecting power cable connectors do not try to join them together without first aligning the half circles inside the connectors Joining together misaligned power cable connectors may dam...

Page 95: ...nt to battery power before disconnecting the Power Module 3 Ensure that the Power Module is unplugged from AC power and disconnected from the patient 4 Inspect the Power Module for dents chips cracks or other signs of damage If the Power Module is not damaged go to Step 5 If the Power Module is damaged contact Thoratec Corporation for a replacement if needed Do not use a Power Module that appears ...

Page 96: ...e crosshead Phillips screwdriver to remove the metal bracket that will hold the internal battery in place Figure 3 7 Figure 3 7 Removing the Metal Bracket 8 Remove the Power Module backup battery from the packaging 9 Place the black battery connector over the metal contact end of the backup battery The contacts should snap into place 10 Gently pull on the connection to ensure that it is secure Fig...

Page 97: ...m clears when AC power is applied to the Power Module 12 Place the Power Module backup battery in the battery compartment Figure 3 9 Figure 3 9 Placing the Battery in the Battery Compartment 13 Complete the following steps a Use the crosshead Phillips screwdriver to reattach the metal bracket b Ensure that the white connectors and wires are not trapped under the metal bracket c Ensure that the con...

Page 98: ...e 3 11 Figure 3 11 Folding the Wires and Connector Along the Top 15 Replace the battery compartment cover and complete the following steps a Use the crosshead Phillips screwdriver to tighten the two turn screws b Ensure that the screws are tight and the cover is securely closed Figure 3 12 Figure 3 12 Tightening the Screws 16 If the Power Module was transported or shipped for service reconnect the...

Page 99: ...Module use and not controlled by a wall switch 1 Power Module power cord TO CONNECT THE POWER MODULE POWER CORD 1 Place the Power Module on a flat sturdy surface 2 Plug the power cord into the Power Module Figure 3 13 Figure 3 13 Plugging the Power Cord into the Power Module 3 Lift the power cord retention clip into the locked position 4 Insert the two ends of the clip into the holes and ensure th...

Page 100: ...lacement if needed The device may be defective Do not use a defective device IMPORTANT Wait for the Power Module backup battery to charge before using the Power Module for the first time after service transportation or after prolonged storage It can take up to 3 hours to charge the backup battery Within a few hours the Power Module backup battery should be charged and ready for use as indicated by...

Page 101: ...er cord to connect to an AC electrical power outlet TO CONNECT THE POWER MODULE PATIENT CABLE 1 Locate the Power Module patient cable Figure 3 16 Figure 3 16 Power Module Patient Cable 2 Align the red dot on the patient cable with the red dot near the heart socket on the Power Module and then insert the patient cable into the socket Figure 3 17 The cable clicks into place when fully engaged in the...

Page 102: ...y is charged The Power Module is plugged in The Power Module patient cable is connected to the socket 4 If the Power Module is being used for the first time perform a Power Module system self test For more information about performing the self test refer to Performing a Power Module Self Test on page 3 22 5 If the Power Module patient cable remains connected to the Power Module when not in use com...

Page 103: ...ed to connect the System Controller to the Power Module Figure 3 19 Care should be used when connecting or disconnecting power cables For more information refer to Guidelines for Power Cable Connectors on page 7 36 Figure 3 19 Power Module Patient Cable FOR THIS TASK YOU NEED A running System Controller A working Power Module that is ready for use A working Power Module patient cable TO CONNECT TH...

Page 104: ...or Figure 3 21 Figure 3 21 Red Dot on the Connector 5 Align the red dot on the connector with the red dot near the heart socket on the Power Module 6 Firmly insert the single connector end into the heart socket on the Power Module Figure 3 22 The connector clicks into place when correctly inserted Figure 3 22 Aligning the Red Dot on the Connector with the Red Dot on the Power Module ...

Page 105: ...nserted connector 8 Place the black and white System Controller power cable connectors within reach Figure 3 23 Figure 3 23 Black and White System Controller Power Cable Connectors 9 Place the black and white Power Module patient cable connectors within reach Figure 3 24 CAUTION Do not pull on or bend the cable as this could damage it 1 White Connector 2 Black Connector 1 2 1 2 ...

Page 106: ...alarm continues until the connection is restored or the silence alarm button is pressed d Promptly align opposite half circles inside the white System Controller power cable connector and the white Power Module patient cable connector Figure 3 25 e Firmly push together the two connectors Figure 3 25 Aligning the Half Circles on the Connectors f Securely hand tighten the connector nut Do not use to...

Page 107: ... for Use 3 21 i Firmly push together the two connectors j Securely hand tighten the connector nut Do not use tools Figure 3 26 System Controller Power Cables Connected to Power Module Patient Cables CAUTION Do not try to join together misaligned connectors Doing so can damage them ...

Page 108: ...HIS TASK YOU NEED 1 Power Module with Power Module backup battery connected Functioning and grounded 3 prong AC electrical outlet that is dedicated to Power Module use and not controlled by a wall switch TO PERFORM A POWER MODULE SELF TEST 1 Press and hold the Power Module s silence alarm button for five seconds 2 Listen for 3 beeps and watch the front of the Power Module If the Power Module passe...

Page 109: ...le backup battery is charged and ready for use in case of power interruption If the Power Module is without AC power for approximately 18 hours or more the Power Module backup battery may be damaged If the Power Module backup battery is damaged an alarm is generated on the Power Module Refer to Power Module Alarms on page 7 30 Emphasize to the patient that inappropriate use during non emergencies ...

Page 110: ... Power Module backup battery is charged and ready for use Yellow Charge Lamp The Power Module backup battery is charging Yellow Battery Advisory Symbol accompanied by beeping audio tone Less than 15 minutes of Power Module backup battery power remain Promptly switch to another power source Red Battery Hazard Symbol accompanied by beeping audio tone Less than 5 minutes of Power Module backup batter...

Page 111: ...ontinuous audio tone sounds and the yellow wrench and red battery symbols illuminate To clear the alarm the Power Module should be disconnected from AC power and then the internal backup battery should be connected To connect the internal backup battery refer to the instructions in Installing the Power Module Backup Battery on page 3 9 Figure 3 27 Green Charge Symbol Power Module Backup Battery is...

Page 112: ...3 Powering the System 3 26 HeartMate III Left Ventricular Assist System Instructions for Use ...

Page 113: ...wer Figure 3 30 Yellow Wrench and Red Battery Hazard Symbol Power Module Backup Battery is Not Working 1 Power On light is yellow 2 Battery Advisory symbol is yellow WARNING If the Wrench Malfunction symbol illuminates yellow and the Battery Hazard symbol illuminates red Figure 3 30 switch to another Power Source immediately 1 Wrench Malfunction symbol is yellow 2 Battery Hazard symbol is red 1 2 ...

Page 114: ...s of time without AC In these situations the battery remains in the battery compartment but is not connected FOR THIS TASK YOU NEED 1 Power Module backup battery installed and connected 1 crosshead Phillips screwdriver TO DISCONNECT THE POWER MODULE BACKUP BATTERY 1 Transfer the patient to battery power prior to disconnecting the Power Module backup battery 2 Place the Power Module on a flat stabl...

Page 115: ... battery Figure 3 33 Figure 3 33 Gently Pulling the Wires and Connectors Away From the Battery 8 Complete the following steps to disconnect a Gently squeeze the white latch on the connector to free the two halves b Pull the connector halves away from each other Figure 3 34 Figure 3 34 Gently Squeezing the Latch Note The Power Module has audio and visual alarms that indicate that the unit is discon...

Page 116: ...ompartment cover and complete the following steps a Use the crosshead Phillips screwdriver to tighten the two turn screws b Ensure that the screws are tight and the cover is securely closed Figure 3 36 Figure 3 36 Tightening the Screws Reconnecting the Power Module Backup Battery The Power Module backup battery should be reconnected any time it may have been disconnected such as for annual mainten...

Page 117: ... if needed Do not use a Power Module that appears damaged 3 Use a crosshead Phillips screwdriver to loosen the two turn screws from the rear panel The screws remain in the screw holes to ensure they are not lost Figure 3 37 Figure 3 37 Loosening the Screws 4 Open the battery compartment cover on the rear of the Power Module Figure 3 38 Figure 3 38 Removing the Battery Compartment Cover 5 Leave the...

Page 118: ...lly engaged 8 Gently fold the wires and white connector along the top of the battery and over the metal bracket screws Figure 3 41 Figure 3 41 Gently Folding the Wires and Connector Along the Top of the Battery 9 Replace the battery compartment cover and complete the following steps a Use the crosshead Phillips screwdriver to tighten the two turn screws b Ensure that the screws are tight and the c...

Page 119: ... the alarm The alarm condition is not resolved as indicated by persistence of the visual alarm Caring for the Power Module Refer to Cleaning and Maintenance on page 8 4 for warnings cautions and instructions on caring for the Power Module Table 3 2 Audio Alarm Silence Periods Audio Alarm How Long Alarm is Silenced Echo System Controller alarm 5 minutes AC Fail Silence lasts until canceled by anoth...

Page 120: ...t There is a potential for strangulation from the system s cables The Mobile Power Unit radiates radio frequency energy If not used according to instructions the Mobile Power Unit may cause harmful interference with nearby devices To confirm interference switch to battery power and then unplug the Mobile Power Unit and observe the effect on devices in the area If interference is detected switch to...

Page 121: ...ygen or nitrous oxide otherwise an explosion could occur CAUTION To avoid the risk of electric shock plug the Mobile Power Unit into a properly tested AC electrical outlet that is dedicated to Mobile Power Unit use Do not use portable multiple outlet power strip adapters or extension cords Avoid covering the Mobile Power Unit such as with a blanket Covering the Mobile Power Unit may reduce the abi...

Page 122: ...eters 24 inches If the condition persists after separating the devices switch to two HeartMate 14 Volt Lithium Ion batteries Keep the Mobile Power Unit free of excessive lint and dust Also keep the Mobile Power Unit away from heat or humidity sources such as a fireplace radiant heater nebulizer or steam kettle The Mobile Power Unit may fail to operate properly due to excessive lint dust heat or hu...

Page 123: ...talled or when the batteries are depleted and need to be replaced Table 3 3 Mobile Power Unit User Interface Components Power On Symbol The power symbol is illuminated green when the Mobile Power Unit is powered and functioning properly Yellow Wrench Alarm The yellow wrench symbol illuminates when the Mobile Power Unit detects a mechanical electrical or software issue with the system This is an Ad...

Page 124: ...gns of damage and complete one of the following steps If the Mobile Power Unit is undamaged go to Step 4 If the Mobile Power Unit is damaged contact Thoratec Corporation for a replacement if needed Do not use a Mobile Power Unit that appears damaged 4 Use a flathead screwdriver or coin to loosen the screw from the rear panel The screw remains in the screw hole to ensure it is not lost Figure 3 44 ...

Page 125: ... battery clip b Place the alkaline AA batteries in the battery compartment Figure 3 46 Figure 3 46 Installing the AA Batteries 9 Replace the battery compartment cover and complete the following steps a Use the flathead screwdriver or coin to tighten the screw b Ensure that the screw is tight and the cover is securely closed Figure 3 47 Figure 3 47 Tightening the Screw 10 Dispose of or recycle the ...

Page 126: ...by a wall switch TO CONNECT THE POWER CORD 1 Place the Mobile Power Unit on a flat sturdy surface 2 Plug the power cord into the Mobile Power Unit Figure 3 48 Figure 3 48 Plugging the Power Cord into the Mobile Power Unit 3 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 a...

Page 127: ...Corporation Refer to page iii for Thoratec Corporation contact information IMPORTANT The power symbol is illuminated green when the Mobile Power Unit is powered and functioning properly 6 If the green Power On light does not come on plug the power cord into another electrical outlet If the green light still does not come on the Mobile Power Unit may have a problem Do not use a defective device Con...

Page 128: ...onnects the System Controller to the Mobile Power Unit Similar to the power cable connectors on the System Controller the connectors on the Mobile Power Unit patient cable are also color coded Figure 3 50 When connecting the System Controller to the Mobile Power Unit patient cable always connect white to white and black to black Figure 3 50 Mobile Power Unit Patient Cable FOR THIS TASK YOU NEED A ...

Page 129: ...s to connect from battery power a Place the batteries with their attached battery clips within reach b Unscrew and disconnect only the white System Controller power cable connector from the attached battery clip c Promptly align opposite half circles inside the white System Controller power cable connector and the white Mobile Power Unit patient cable connector Figure 3 52 Figure 3 52 Carefully Al...

Page 130: ...only the black System Controller power cable connector from the attached battery clip g Promptly align opposite half circles inside the black System Controller power cable connector and the black Mobile Power Unit patient cable connector h Firmly push together the two connectors i Tighten the connector nut until secure Hand tighten only Do not use tools Figure 3 55 System Controller Power Cables C...

Page 131: ...e Mobile Power Unit requires little planned maintenance However it should be inspected routinely to ensure the safest and best possible performance For complete information about caring for the Mobile Power Unit refer to Caring for the Power Module and Mobile Power Unit on page 8 6 IMPORTANT Periodically and as needed use a clean damp not wet cloth to clean the exterior surfaces of the Mobile Powe...

Page 132: ...ing A pair of HeartMate 14 Volt Lithium Ion batteries Figure 3 57 provides direct current DC to the Pump Both batteries are discharged together not one then the other Figure 3 57 HeartMate 14 Volt Lithium Ion Battery Each battery is inserted into a 14 Volt battery clip Figure 3 58 The batteries and attached battery clips can be worn in holsters one under each arm or across the body in a bag or in ...

Page 133: ...l battery Refer to Checking Battery Charge Status on page 3 50 Required Components Components for operating the HeartMate III system on battery power include the following 2 fully charged HeartMate 14 Volt Lithium Ion batteries 2 compatible 14 Volt battery clips In addition the System Controller must be connected to the LVAD via the Driveline IMPORTANT HeartMate batteries only work in matching pai...

Page 134: ...maged defective or expired batteries may reduce operating time or the pump may stop 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 Calibrate a battery as soon as possible after being prompted to prevent a backlog of uncalibrated batteries After approximately 70 uses HeartM...

Page 135: ... date of manufacture whichever comes first If a 14 Volt Lithium Ion battery leaks do not touch the leaking fluid If the fluid touches skin or eyes wash the affected area with plenty of water and seek medical advice To prevent deterioration or damage to a 14 Volt Lithium Ion backup battery Do not store in direct sunlight Store within approved temperatures 14 F to 104 F 10 C to 40 C Refer to Storage...

Page 136: ...ttery is 80 100 charged Fewer bars illuminate as power is depleted When battery power drops below 10 only one green blinking bar comes on Figure 3 61 On Battery Power Gauge and Pressing the Battery Symbol to Activate Bars FOR THIS TASK YOU NEED 1 HeartMate 14 Volt Lithium Ion battery Battery Charger TO CHECK THE BATTERY CHARGE STATUS USING THE BATTERY POWER GAUGE 1 Obtain a battery from one of the...

Page 137: ...harged If the yellow light next to the pocket is on the battery is still charging If the red light next to the pocket is on the battery has a problem Do not use it If all of the power gauge bars come on except for one in the middle of the sequence the light emitting diode LED for the bar may be broken or burned out If this happens contact Thoratec Corporation Refer to page iii for Thoratec Corpora...

Page 138: ...o Charging HeartMate Batteries on page 3 72 Two HeartMate 14 Volt Lithium Ion battery clips One battery holster or other accessory for holding or carrying in use batteries TO CONNECT THE SYSTEM CONTROLLER TO 14 VOLT BATTERIES 1 Gather the equipment 2 Insert a charged HeartMate 14 Volt Lithium Ion battery into each 14 Volt battery clip Refer to Using HeartMate 14 Volt Lithium Ion Batteries on page ...

Page 139: ...ctor for one of the battery clips Figure 3 63 Figure 3 63 Aligning the Half Circles on the Connectors 7 Firmly push together the two connectors 8 Securely hand tighten the connector nut Do not use tools 9 Repeat Steps 5 through 8 for the black System Controller power cable connector and the second battery clip connector Figure 3 64 System Controller Power Cables Connected to Battery Clips WARNING ...

Page 140: ...user interface The words Low Battery and Replace Power Immediately alternate on the user interface screen Alarm tone constant tone The Low Battery Power Hazard Alarm requires an immediate response Refer to System Controller Alarms on page 7 3 for detailed instructions on responding to System Controller alarms During a Low Battery Power Hazard Alarm the system reverts to power saver mode and gradua...

Page 141: ...wering the system and remove the clip and battery from the holster carrying case Do not remove the battery from its clip at this time 6 Locate the battery power gauge symbol on the battery that was removed in Step 5 and complete the following steps a Press and hold the battery symbol for five seconds b Observe how much battery power remains for this battery by counting the number of bars that ligh...

Page 142: ...tery into the battery clip The battery should click into place f Gently pull on the battery and try to remove it from the clip If the battery is properly and fully inserted the battery remains in the clip and the System Controller s Power Cable Disconnect alarm will stop g Remove the other depleted battery and repeat Steps a f 10 Return the clips and charged batteries to the holsters or carrying c...

Page 143: ...ies out of service A new battery that is stored and used according to the acceptable environmental conditions should be usable for approximately 360 cycles or 36 months from the date of manufacturer whichever comes first After this time battery performance cannot be guaranteed Call Thoratec Corporation for a replacement when either of these milestones is reached Refer to Storage and Transport on p...

Page 144: ...Line up the arrows on the battery and battery clip b Push until the battery clicks into place 3 Repeat Step 2 for the second battery and battery clip 4 Unscrew the white System Controller and white Power Module patient cable connectors The Power Cable Disconnect alarm will come on This is normal 5 Put aside the white Power Module patient cable connector 6 Promptly connect the battery clip connecto...

Page 145: ...power cable connector The alarm will stop when the black System Controller power cable is connected 10 Place the batteries and battery clips into the holsters or carrying case 11 Keep the Power Module patient cable connected to or near the Power Module until next use 12 Place at least two additional charged batteries in the travel case IMPORTANT If the Power Module patient cable remains connected ...

Page 146: ... will come on This is normal 5 Promptly connect the battery clip connector to the white System Controller power cable connector Figure 3 67 The alarm will stop when the white System Controller power cable is connected Figure 3 67 Connect the System Controller Power Cable Connector to the Battery Clip Connector 6 Unscrew the black System Controller and black Mobile Power Unit patient cable connecto...

Page 147: ...at is dedicated to Power Module use 2 Perform a Power Module self test and complete one of the following steps If the Power Module passes the self test go to Step 3 If the Power Module fails the self test contact Thoratec Corporation Refer to Performing a Power Module Self Test on page 3 22 3 Complete one of the following steps If the Patient Cable is connected to the Power Module continue to Step...

Page 148: ...within reach 6 Remove the battery clips and attached batteries from the patient s holsters or carrying case 7 Press the battery power gauge on each battery to determine which battery has the least power Refer to Checking Battery Charge Status on page 3 50 8 Complete one of the following steps If one battery has less charge start with that battery and disconnect the connector from the battery If bo...

Page 149: ...clip and attached battery 14 Connect the black Power Module patient cable connector to the black System Controller power cable connector The alarm will stop 15 Press the battery release button on one of the battery clips to release its battery 16 Repeat Step 15 for the second battery The System Controller is now connected to the Power Module and the Power Module is powering the system Store the ba...

Page 150: ...le connectors within reach 3 Remove the battery clips and attached batteries from the patient s holsters or carrying case 4 Press the battery power gauge on each battery to determine which battery has the least power Refer to Checking Battery Charge Status on page 3 50 5 Complete one of the following steps If one battery has less charge start with that battery and disconnect the connector from the...

Page 151: ...n until the next use 16 Place the depleted batteries into the Battery Charger for charging Refer to Charging HeartMate Batteries on page 3 72 Battery Charger Overview The Battery Charger Figure 3 70 is designed to charge the HeartMate 14 Volt Lithium Ion batteries that are used to power the HeartMate III Left Ventricular Assist System during battery powered operation Specifically the Battery Charg...

Page 152: ... used to power the Battery Charger To avoid the risk of electrical shock plug the Battery Charger into a properly tested and grounded 3 prong AC electrical power outlet that is dedicated to Battery Charger use Do not use an outlet that is controlled by a wall switch Do not use an adapter plug for an ungrounded wall outlet Do not use portable multiple outlet power strip adapters Keep the Battery Ch...

Page 153: ...res planned maintenance at least once every 12 months for the best possible operation Planned maintenance includes but is not limited to a functional check of the device and cleaning inspecting all internal connections Service and maintenance of the Battery Charger should be performed only by service personnel who are trained by Thoratec Corporation Make sure the Battery Charger is plugged in and ...

Page 154: ...ts Dirt or objects covering the metal contacts inside the pockets may prevent proper battery charging which can affect battery performance 5 Obtain the grey AC power cord from the product packaging 6 Plug the female end of the power cord into the power entry module on the rear of the charger Figure 3 71 Figure 3 71 Plugging the Power Cord Into the Battery Charger 7 Plug the Battery Charger into a ...

Page 155: ...y panel Figure 3 73 The charger is ready for use Figure 3 73 HeartMate CHARGER Screen on the Battery Charger OR If the charger detects a problem an error message appears on the display panel and or the lights and beep are not performed as described for a successful self test Refer to Using the Charger to Check Battery or Charger Status on page 7 33 for how to respond to advisory messages if any of...

Page 156: ...GER 1 Unpack and plug in the Battery Charger Do not turn on the Battery Charger at this time 2 Press and hold buttons 1 and 3 on the front panel of the charger Figure 3 75 while simultaneously pressing the power switch to the on position Figure 3 75 Pressing and Holding Buttons 1 and 3 to Change the Display Mode 3 After the word English appears on the display Figure 3 76 release buttons 1 and 3 Fi...

Page 157: ...harging pockets 2 Turn off the charger by pressing the on off switch from the on I to the off 0 position Do not unplug the Battery Charger 3 Press and hold buttons 1 and 3 on the front panel of the charger and press the power switch to the on I position 4 After the display panel lights up release the 1 button and the 3 button The Battery Charger powers up 5 Use the 2 button to scroll down to the p...

Page 158: ...s available battery power and counts battery usage charge cycles When a battery is placed in a charging pocket Figure 3 77 the charger immediately checks the battery s status by reading the battery s on board computer chip Figure 3 77 Batteries Inserted into Battery Charger Pockets To view information about the battery s available power and total number of use charge cycles on the charger s displa...

Page 159: ...ttery only fits in the pocket with the battery power gauge at the top and facing forward When the battery is properly placed in the pocket a beep sounds and one of the pocket lights is illuminated green yellow or red 1 Place a battery into one of the four battery charging pockets The battery power gauge should be at the top and facing forward Figure 3 79 Figure 3 79 Battery Charger with Batteries ...

Page 160: ... no light insert the battery into a different pocket If the battery cannot be charged in a different pocket the battery is defective Do not use the defective battery Contact Thoratec Corporation for a replacement if needed Refer to Using the Charger to Check Battery or Charger Status on page 7 33 for information on advisory messages and troubleshooting including how to read alarm codes when a red ...

Page 161: ...ended The yellow light for the pocket blinks A split battery symbol and the pocket number for the battery flashes on the charger display panel Figure 3 80 The circled number switches between a filled and unfilled circle as the display panel screen flashes Figure 3 80 Calibration Prompt in Graphic Mode Indicating that the Battery in Pocket 4 Needs Calibration Batteries can be calibrated when prompt...

Page 162: ...ontinues with a normal charge cycle IMPORTANT It is acceptable to charge and reuse the battery but it should be calibrated as soon as possible If the battery calibration is canceled after the calibration process has begun complete the following steps 1 Remove the battery from its charging pocket to cancel the calibration 2 If the battery is removed before calibration is complete recharge and check...

Page 163: ...example if approximately 50 of the battery s power is available half of the battery symbol is filled and 50 appears on the screen Figure 3 82 Battery Charge Level on the Battery Charger 90 Charge After five seconds the display returns to the default screen HeartMate CHARGER 3 Press the number button for that pocket again while the battery charge level appears for the total number of use charge cyc...

Page 164: ...g the Battery Charger refer to Safety Checklists on page D 1 IMPORTANT The hospital contact is responsible for coordinating annual inspection and maintenance of the Battery Charger after the patient leaves the hospital Disposing of the Battery Charger Refer to Product Disposal on page 8 8 for information about disposing of the Battery Charger CAUTION Service and maintenance of the Battery Charger ...

Page 165: ...ribes how to use the System Monitor to program and monitor the HeartMate III Left Ventricular Assist System Overview 4 3 System Monitor Setup 4 5 System Monitor Interface 4 9 Clinical Screen 4 10 Settings Screen 4 17 Alarms Screen 4 25 Save Data Screen 4 32 Using the History Screen 4 38 Admin Screen 4 40 ...

Page 166: ...4 System Monitor 4 2 HeartMate III Left Ventricular Assist System Instructions for Use ...

Page 167: ...e 4 1 Figure 4 1 System Monitor Mounted on Top of the Power Module Function For the System Monitor to work it must be connected to the Power Module via the System Monitor data cable In addition the Power Module must be connected to the System Controller This allows the transfer of System Controller data through the Power Module for display on the System Monitor screen The System Monitor is used to...

Page 168: ...s manual or sold by Thoratec Corporation for replacement parts may affect the electromagnetic compatibility of the Left Ventricular Assist System with other devices This could result in potential interference between the Left Ventricular Assist System and other devices If the System Monitor is mounted on top of the Power Module do not attempt to lift or carry the two components together using the ...

Page 169: ...unded 3 prong AC electrical outlet 1 AC power cord TO SET UP THE SYSTEM MONITOR FOR USE WITH THE POWER MODULE 1 Complete the following steps to connect the System Monitor to the Power Module a Plug the System Monitor data cable into the socket located on the side of the Power Module Figure 4 2 b Check that the connection is secure Figure 4 2 Plugging the System Monitor Data Cable into the Power Mo...

Page 170: ...able is securely connected to the System Monitor and the Power Module The System Monitor power switch is on The Power Module is running on AC power and not its backup battery The green Power On light on the front of the System Monitor is illuminated If the words Not Receiving Data flash on the System Monitor screen check the following The Power Module patient cable is securely inserted into the Po...

Page 171: ... minimizes the space needed when a patient requires continuous monitoring while connected to the Power Module Figure 4 4 System Monitor Mounted on the Power Module FOR THIS TASK YOU NEED 1 running System Controller connected to the Power Module via Power Module patient cable 1 working in use Power Module 1 System Monitor 1 System Monitor data cable Functioning and grounded 3 prong AC electrical ou...

Page 172: ... of the Power Module Figure 4 5 Figure 4 5 Sliding the Back Edge of the System Monitor Base Under the Ledge of the Power Module 2 When the back edge of the System Monitor is secure under the ledge press down firmly on the top of the System Monitor This engages the two feet on the System Monitor into the holding grommets on the Power Module Figure 4 6 Figure 4 6 Engaging the System Monitor Feet in ...

Page 173: ...pted operations that are accessible from six main screens Six tabs representing the six main screens are continuously displayed along the top of each screen Touching the on screen tab allows access to the corresponding screen Each screen has unique system functions The tab for the in use screen is highlighted in black Figure 4 7 In this example the Clinical screen is in use Figure 4 7 System Monit...

Page 174: ...the preferred speed setpoint The speed setpoint for fixed mode has a range of 3 000 to 9 000 rpm The Operating Mode is Pulse Active Alarm Messages The two highest priority active alarm messages are displayed below the operating mode Command Buttons Two command buttons appear during certain conditions A Pump Start button appears when the pump is stopped or disconnected from the System Controller Pr...

Page 175: ...xpected operational range or acceptable linear region a Low Flow alarm is triggered and the Pump Flow box displays Figure 4 9 This situation only occurs when Pump speed is below 4000 rpm AND the Pulse Index is greater than 9 0 This prevents the display of inaccurate flow information Figure 4 9 Low Flow Alarm and Pump Flow Box When the Driveline is disconnected from the System Controller appears in...

Page 176: ...der the following conditions the Pump can only be started from the System Monitor s Clinical or Settings screen by pressing the Pump Start button The Fixed Speed setting is below 4 000 rpm AND The System Controller s backup battery is not installed If the Pump stops because the Driveline is disconnected from the System Controller the Pump restarts at the previously set speed when the Driveline is ...

Page 177: ...onditions Figure 4 12 Figure 4 12 Pump Speed Displayed in Revolutions Per Minute RPM If the Pump becomes disconnected from the System Controller the Pump Speed box displays Driveline Disconnected Figure 4 13 Figure 4 13 Driveline Disconnected Message When the Pump is stopped using the Pump Stop button a zero 0 appears in the Pump Speed box If a Communication Fault exists appears in the pump speed ...

Page 178: ...tility that is the Pump is providing more support and the heart is providing less support Pulsatility Index appears in the upper right corner of the Clinical screen Figure 4 15 Figure 4 15 Pulsatility Index When the Pump is stopped or the Driveline is disconnected from the System Controller appears in the Pulse Index box Figure 4 16 Figure 4 16 Pulsatility Index When the Pump is Stopped Pump Power...

Page 179: ...the patient Hazard alarms require immediate attention Hazard alarms flash and appear as black text on a red banner On screen messages for hazard alarms are accompanied by a continuous audio tone from the System Controller Five hazard alarms are displayed on the System Monitor The on screen appearance of each alarm is described as follows in order of descending priority PUMP OFF This text banner is...

Page 180: ...re may be instances when there is no audible alarm WARNING Low Speed Advisory A text banner appears however there is no audible alarm Backup Battery Not Installed This text banner is accompanied by one beep every four seconds LVAD Fault A text banner appears however there is no audible alarm Driveline Power Fault This text banner is accompanied by one beep every four seconds Driveline Communicatio...

Page 181: ...Command Buttons The Fixed Speed Adjust Low Speed Limit Hematocrit Adjust and Pump Stop Start command buttons are displayed at the bottom of the screen During alarm conditions and hematocrit adjust a Silence Alarm button accompanies any active alarm Press the Silence Alarm button to silence Hazard and Power Cable Disconnect alarms for two minutes and all other Advisory alarms for four hours For det...

Page 182: ... the total number of minutes that the System Controller s 11 Volt Lithium Ion backup battery has been used High numbers may indicate that a patient is inappropriately relying on the backup battery for non emergency support Select Fixed Speed The buttons in the Select Fixed Speed box are used to increase or decrease the Fixed Speed of the Pump The Fixed Speed is adjustable in increments of 100 rpm ...

Page 183: ... determining the optimal Fixed Speed that will provide the preferred level of cardiac support for each patient The Fixed Speed setting generally falls midway between the minimum and maximum speeds It is based on changes in ventricular shape and function and the patient s physiological response to changing Pump speeds Performing a Ramped Speed Study A ramped speed study is intended for hemodynamica...

Page 184: ...atient s current heart rate blood pressure and Pump speed c Using echocardiography record the patient s left ventricular diameter and frequency of aortic valve opening 8 Based on findings from the speed study determine the optimum Fixed Speed which usually falls midway between the minimum and maximum speeds IMPORTANT The selected speed may be adjusted based on clinical judgment regarding the need ...

Page 185: ...t the WARNING Low Speed Advisory alarm message appears If the system detects a PI event the Pump speed automatically drops to the Low Speed Limit and slowly ramps back up at a rate of 100 rpm per second to the Fixed Speed setpoint This drop in speed is accompanied by a reduced Pump flow If the Low Speed Limit is set at a value above or the same as the Fixed Speed setpoint the Pump speed does not c...

Page 186: ...t few seconds of holding down the Pump Stop button However if the button is released before the countdown is complete the Pump resumes at the previously set mode and speed After the countdown the Stopping Pump message appears The countdown lasts for approximately 10 seconds Figure 4 22 Figure 4 22 Pump Stop Countdown Starts Initially the WARNING Low Speed advisory alarm and then the LOW FLOW Hazar...

Page 187: ...tton When the PUMP OFF alarm appears a continuous audible alarm sounds 3 After the Pump Stop countdown is complete press Silence Alarm to silence this alarm for two minutes Figure 4 24 Figure 4 24 Pump Stop Countdown Completion After the Pump Stop Countdown ends a Pump Start button appears 4 Press Pump Start to restart the Pump at the previously set mode and speed The following message appears Fig...

Page 188: ... and Hematocrit The System Controller provides an estimate of blood flow out of the Pump To have a more accurate prediction the System Controller uses the patient s hematocrit level as a surrogate for the patient s blood viscosity Viscosity is a fluid property that can influence the flow estimate algorithm The System Controller has a default hematocrit value of 35 To assure the most accurate flow ...

Page 189: ...nce the Hazard and the Power Cable Disconnect alarms for two minutes and all Advisory alarms for four hours An Extended Silence button accompanies active audible alarms when the Fixed Speed is set below 4 000 rpm Press this button to silence all Hazard and Advisory alarms for four hours Figure 4 27 Alarms Screen IMPORTANT Active alarm messages are only shown on the Clinical Settings and Alarms scr...

Page 190: ...e System Controller NO EXTERNAL POWER The System Controller is not receiving external power from either power cable and Pump function is being supported by the System Controller s backup battery Immediately connect the System Controller to a power source Power Module Mobile Power Unit or two HeartMate 14 Volt Lithium Ion batteries LOW FLOW Pump flow is less than 2 5 lpm the Pump has stopped the Pu...

Page 191: ...er has been lost due to a problem with the internal communication system or the primary and back up communication wires in the Driveline are not functioning Use the System Monitor to silence the alarm while awaiting resolution if needed Also exchanging the Modular Cable of the Driveline may resolve the problem Refer to Replacing the Modular Cable on page 2 51 If exchanging the Modular Cable does n...

Page 192: ...access the alarm silence Driveline Communication Fault Indicates that one of the redundant communication handling wires inside the Driveline may be damaged or broken Contact Thoratec Corporation to determine best next steps Use the System Monitor to silence the alarm while awaiting resolution if needed Note The alarm must be the highest priority active alarm to access the alarm silence Controller ...

Page 193: ...ilence indicator in the parameters box displays ON When the alarm condition is resolved the alarm automatically turns off and the Alarm Silence indicator displays OFF The Silence Alarm button is not available for LVAD Fault Driveline Power Fault or Driveline Communication Fault Extended Silence Alarm Button At fixed speeds set below 4 000 rpm and with any active alarm the Extended Silence button i...

Page 194: ...ccess the Alarm screen of the System Monitor and press the Clear Driveline Power Alarm button If the alarm condition persists this alarm will be reactivated If it was a transient condition this alarm will not be reactivated Figure 4 30 Silence Driveline Power Fault Alarm This action will permanently silence the audio portion of the Driveline Power Fault Alarm and the System Controller will no long...

Page 195: ...he Alarm screen of the System Monitor and press the Clear Driveline Comm Fault Alarm button If the alarm condition persists this alarm will be reactivated If it was a transient condition this alarm will not be reactivated Figure 4 31 Silence Driveline Communication Fault Alarm This action will permanently silence the audio portion of the Driveline Communication Fault Alarm The System Controller wi...

Page 196: ...roller and LVAD are recorded and saved Save the System Controller and LVAD periodic data to the data card The Save Data screen contains these boxes Figure 4 32 System Controller Periodic Data LVAD Periodic Data Periodic and Event History Figure 4 32 Save Data Screen IMPORTANT Alarm messages do not appear on the Save Data History or Admin Screens Go to the Alarms screen to view alarm messages ...

Page 197: ...inue Enter or Save If one of these buttons is not pressed the changes will not be saved Figure 4 33 Data Card left and Inserting Data Card into System Monitor right IMPORTANT When information is saved to a data card for a specific patient be sure to use the same patient identification ID number every time information is saved for that patient Using different ID numbers makes it difficult to identi...

Page 198: ...rd 256 periodic logs When the log is full the oldest record is replaced with newest record Frequencies include 10 minutes 20 minutes 30 minutes and 1 hour to 24 hours in one hour increments To enable and configure the System Controller Periodic Data log complete the following steps 1 Select the Save Data screen on the System Monitor 2 Press Modify located under Controller Periodic Data Figure 4 34...

Page 199: ... SAVE SYSTEM CONTROLLER EVENTS THAT ARE LOGGED IN THE SYSTEM MONITOR 1 Ensure that a data card is inserted into the System Monitor 2 Press Save to Card The Patient ID screen appears 3 Verify that the date and time top left corner of the screen are correct and complete one of the following steps If the date and time are correct go to Step 4 If the date and time are not correct go to the Admin scree...

Page 200: ...ages All Data Captured Successfully and Press any button to continue Figure 4 37 Figure 4 37 Data Captured Successfully 6 Press any button to return to the Save Data screen If a button is not pressed the Clinical screen automatically appears after 60 seconds 7 Remove the data card from the System Monitor Contact Thoratec Corporation regarding questions about accessing or understanding event histor...

Page 201: ...e data can then be sent via e mail A card reader is available through Thoratec Corporation Figure 4 38 The card reader plugs into any USB port on a personal computer PC and acts as a removable drive Note that the drive designation may differ based on the PC s specific configuration Figure 4 38 Card Reader IMPORTANT A PC running Microsoft Windows 2000 or higher is required for most card readers Con...

Page 202: ...een contains Seven Column Table System parameters alarms and event times are displayed in a seven column table Figure 4 40 Figure 4 40 History Screen Table Columns Four Navigation Buttons The navigation buttons located in the lower right of the screen allow users to move through the multiple screens of events The left most button opens the first page the second and third buttons move between pages...

Page 203: ...the History screen appears It displays the most up to date controller event history that is stored in the System Controller Reviewing Events A maximum of 256 events can be stored and retrieved for display The event history data are displayed in reverse chronological order with the most recent events at the top of the screen System Information indicates that those data were recorded as part of an E...

Page 204: ... parameters such as Pump speed power flow or the pulsatility index Figure 4 43 Figure 4 43 Admin Screen Date and Time The System Monitor and System Controller have separate clocks They can be set independently from each other Logs and event history always reflect the date and time on the System Controller s clock To synchronize the date and time on the System Controller with the System Monitor pre...

Page 205: ...ontroller appears It has on screen instructions Figure 4 44 Figure 4 44 Set Date and Time Screen for System Monitor 3 Use the numerical keypad to enter the date and time Include zeros so that ten digits are entered For example to enter the date and time 10 11 10 15 58 type 1011101558 If less than ten digits are entered an error message appears 4 Press Save Changes to save the new date and time A p...

Page 206: ...ple languages To select a language for the System Controller complete the following steps 1 Press Modify for Language 2 Use the buttons at the bottom of the screen to view and select the preferred language Available languages are listed in alphabetic order The first language listed is the one currently in use on the System Controller Figure 4 46 Figure 4 46 Select Language Screen ...

Page 207: ... inside the System Controller can power the Pump for at least 15 minutes during a power loss emergency Items capitalized are fixed characteristics of the backup battery Items in mixed case are variable and change with backup battery use Figure 4 47 Figure 4 47 System Controller Information Screen Technical Parameters This screen provides access to the parameters Access to this screen is restricted...

Page 208: ...4 System Monitor 4 44 HeartMate III Left Ventricular Assist System Instructions for Use ...

Page 209: ...quired for Implant 5 5 Preimplant Procedures 5 7 Unpacking the Implant Kit 5 10 Unpacking the Pump and Accessories Tray 5 11 Unpacking the Sealed Outflow Graft 5 14 Preparing the Sealed Outflow Graft 5 15 Unpacking the System Controller 5 16 Unpacking the Modular Cable 5 17 Connecting and Initializing the Sterile System Controller 5 19 Preparing Operating and Priming the Pump 5 22 Preparing the Co...

Page 210: ...5 Surgical Procedures 5 2 HeartMate III Left Ventricular Assist System Instructions for Use ...

Page 211: ...power the LVAS when the patient is being transferred out of the operating room All users including clinicians patients and caregivers must be trained on HeartMate III power accessories Power Module Mobile Power Unit Battery Charger and batteries before use Certain parts of the HeartMate III Left Ventricular Assist System are not compatible with other HeartMate systems such as the HeartMate II Left...

Page 212: ... of high power mains treatments could result in mains interference with system operation causing the Pump to stop Implanted components should not be exposed to therapeutic levels of ultrasound energy for example ultrasound heating and or extracorporeal shockwave lithotripsy used to alter or ablate tissue as the device may inadvertently concentrate the ultrasound field and cause harm This does not ...

Page 213: ... HeartMate III Left Ventricular Assist System LVAS Implant Kit include the following Left Ventricular Assist Device LVAD Assembly 14mm Sealed Outflow Graft with Bend Relief Apical Cuff Apical Coring Knife 20mm Skin Coring Punch 6mm Outflow Thread Protectors 1 set Modular Cable with Modular Cable Cap Tunneling Adapter System Controller CAUTION Components of the HeartMate III Left Ventricular Assist...

Page 214: ...de a System Monitor and Power Module Figure 5 1 In addition the following items are required Small Drip Basin Sterile Graduated Pitcher 1 000 cc Emesis Basins 2 Vent Needle CV Major Surgical Set Heavy Non Absorbable Ligature Catheter Tipped Syringe with Sterile Normal Saline 12 pledgeted horizontal mattress 2 0 braided sutures WARNING Power Modules are shipped to customers with the internal batter...

Page 215: ...is damages the Pump and Driveline All entrapped air must be removed from the Pump sealed Outflow Graft assembly blood path to minimize the risk of air embolus CAUTION Operators must prevent blood from entering and collecting in the lumen of the conduits Blood on the inner lumen may increase the risk of thromboembolism due to coagulum breaking free in the circulatory system The inner lumen must the...

Page 216: ...or to implant ensure that all equipment is in good working order and ready including what is on hand in the operating room This section describes how to initialize the Power Module and System Monitor During implant the HeartMate III LVAD must be operated with the Power Module and System Monitor Figure 5 1 Note If an older model of the System Monitor cable is used use an adapter to connect the Syst...

Page 217: ...tem Monitor illuminates go to Step 7 If the System Monitor does not power on perform troubleshooting steps to resolve the issue Refer to Setting Up the System Monitor for Use with the Power Module on page 4 5 7 Observe the System Monitor screen and complete one of the following steps If the HeartMate logo screen appears the System Monitor is ready for use with the Power Module Figure 5 2 If the lo...

Page 218: ...within a common plastic container The LVAD inner tray has a snap on plastic lid cover which is sealed by a Tyvek lid to maintain sterility Note The operating room has several sterile fields Use care when unpacking items as several of the items must be placed in the sterile fields Unpack the components in the following order Left Ventricular Assist Device LVAD Pump and Accessories Tray System Contr...

Page 219: ...r from the main packaging tray Figure 5 3 Figure 5 3 Main Packaging Tray 2 Remove the Pump and accessories trays from the main packaging tray Figure 5 4 Figure 5 4 Pump and Accessories Trays 3 Peel back and remove the lid from the Pump Tray Figure 5 5 Figure 5 5 Pump and Accessories Tray WARNING Only sterilized personnel using sterile technique should make contact with sterilized implant kit acces...

Page 220: ...er Removal of Pump and Cable from the Tray 6 Move the sterile Pump to the pump preparation sterile area 7 Inspect the quality of the white washer in the outlet 8 Maintaining strict sterile technique screw the sterile Tunneling Adapter on to the Pump Cable connector 9 Ensure that the adapter is completely screwed down tight by covering the yellow line on the in line connector CAUTION Gently guide t...

Page 221: ... Use 5 13 10 Grip the notched cutout of the Accessories Tray and peel back the lid Figure 5 7 Figure 5 7 Accessories Apical Sewing Cuff Thread Protectors Coring Knife and Skin Punch 11 Remove all the sterile components from the Accessories Tray and place them in the sterile work area ...

Page 222: ...nt The foil pouch is a protective cover only and should not be introduced into the sterile field 2 Remove the outer tray from the foil pouch Figure 5 8 The outer tray is not sterile Only the innermost tray may be introduced into the sterile field Figure 5 8 HeartMate III Sealed Graft With Bend Relief 3 Peel back the lid to expose the sealed Outflow Graft 4 Remove the sealed Outflow Graft and Bend ...

Page 223: ...ict sterile technique Complete the following procedure 1 Remove the Bend Relief from the graft 2 Inspect the interior of the graft and remove any debris 3 Attach the open thread protector 4 Place the Bend Relief over the graft with the metal end sliding toward the screw ring The Bend Relief should be disengaged for the de airing procedure Only the Vascular Graft is intended to be cut or clamped no...

Page 224: ...r of the outer plastic tray and then peel back the lid of the inner tray 2 Remove the inner tray from the packaging Figure 5 10 Figure 5 10 Controller in Tray 3 Peel back the cover of the inner tray to expose the System Controller Figure 5 11 Figure 5 11 System Controller 4 Remove the System Controller from the tray and move it to the sterile working area 5 Secure the power cables so that they sta...

Page 225: ...ing the Modular Cable and remove the plastic tray Figure 5 12 Figure 5 12 Modular Cable in Packaging 2 Peel back the lid of the outer plastic tray and then peel back the lid of the inner tray Figure 5 13 Figure 5 13 Outer and Inner Plastic Trays with Lids Peeled Back from Modular Cable 3 Remove the sterile Modular Cable and the Modular Cable Cap from the packaging The Modular Cable Cap protects th...

Page 226: ...to the Modular Cable Cap b Press firmly until the Modular In Line Connector bottoms inside the Modular Cable Cap c Ensure that the Modular In Line Connector is fully inserted into the Modular Cable Cap d Wrap a clean and dry sterile towel around the Modular Cable Cap and Modular In Line Connector e Move the Modular Cable to the sterile work area Figure 5 14 Figure 5 14 Covering the Modular In Line...

Page 227: ...roller 3 Verify that a flashing communication icon is shown in the lower left corner of the System Monitor screen This icon is displayed on all screens It establishes that the System Monitor is properly connected to the System Controller and that the correct monitoring software is running Note If the communication icon is not flashing check connections and restart the monitor 4 Go to the Admin scr...

Page 228: ...that the screen displays the pump off low flow and Driveline Disconnected alarm messages and indicates Pulse Mode with dashes in the Setpoint display Figure 5 15 Figure 5 15 System Monitor Clinical Screen When Initially Connected to the System Controller 1 Active Hazard Alarms 2 Fixed Speed Setpoint 1 2 ...

Page 229: ...ded 10 Cancel the extended silence alarm by completing one of the following steps Press the Silence Alarm button on the System Controller s user interface panel Disconnect the System Monitor from the Power Module System Controller configuration is now complete The Driveline Disconnected alarm will remain active until the System Controller is connected to the LVAD The Pump Off alarm message will re...

Page 230: ...Modular Cable Controller Connector into the System Controller until the connector clicks and locks into place d Gently tug on the end of the Modular Cable Controller Connector to ensure proper engagement e Lock the Modular Cable connection to the System Controller by sliding the cable Safety Lock in the direction of the lock symbol until the red button is no longer visible 2 Prepare a sterile grad...

Page 231: ...de between the Pump and the System Controller 6 Remove the adapter and cap by completing the following steps a If the Pump Cable connector and Tunneling Adapter are wet dry the connector area with a clean and dry sterile towel b Using a clean and dry sterile towel grip the connector area and disconnect the Tunneling Adapter orienting the Tunneling Adapter downward c Leave the Tunneling Adapter tie...

Page 232: ... of the in line connector to the locked position as indicated on the markings Figure 5 19 Figure 5 19 Pushing the In Line Connectors Together and Rotating the Locking Nut f Listen for a clicking sound as the locking nut is rotated The clicking sound is normal g Continue to tighten until the clicking sound stops h Turn the locking nut until the yellow line on the threaded portion of the connector i...

Page 233: ...igure 5 20 The Pump may take up to 10 seconds to start The PUMP OFF message should disappear Figure 5 20 Pump Settings Screen 9 If the speed setpoint is not 3 000 rpm complete the following steps a On the System Monitor access the Settings screen b Press the Fixed Speed Adjust button c Follow the on screen instructions to set the speed to 3 000 rpm d During the next five minutes ensure that the Pu...

Page 234: ...e Settings screen for 10 seconds until the Pump Stop button disappears The Pump Off message appears and the Pump Stop button changes to Pump Start 13 Disconnect the in line connector by completing the following steps a Unthread the locking nut in the direction of the unlock symbol b Listen for a clicking sound as the locking nut is rotated The clicking sound is normal c Continue to unthread the lo...

Page 235: ... Cable 18 Wrap a clean and dry sterile towel around the Modular Connector Cap and in line connector The Modular Connector Cap protects the connector from fluids and debris Do not disconnect the Modular Cable from the System Controller 19 Ensure that the cable stays sterile 20 Secure the length of the Modular Cable attached to the System Controller so it does not fall out of the sterile field 21 Le...

Page 236: ...s out of the cap 25 Close the Luer Lok cap 26 Gently tap the side of the Pump and observe air bubbles rising to the surface 27 Tap and add saline until the Pump appears full and no further air bubbles can be observed 28 Remove all entrapped air from the Pump blood path to minimize the risk of air embolus 29 Cut a fingertip off of a powder less sterile glove and use it to cover the Inlet extension ...

Page 237: ... end caps to the Coring Knife Figure 5 24 Figure 5 24 Coring Knife 2 Take the Coring Knife handle and insert it through the holes in the side of the Coring Knife Figure 5 25 Figure 5 25 Assembling the Coring Knife Handle 3 Insert the handle so it creates a T handle Figure 5 26 This enables handling of the tool during surgical procedure Figure 5 26 Assembled Coring Knife WARNING The cutting end of ...

Page 238: ...V apical cannulation with the Pump placed within the pericardial space between the ventricular apex and the diaphragm An abdominal pocket is not required for implantation Therefore entry into the abdominal cavity will not be performed The sealed Outflow Graft attached to the ascending aorta and the Pump Cable exits the right upper quadrant of the abdomen and connects to the external equipment Figu...

Page 239: ...ped air must be removed from the device blood pumping chamber and conduits to reduce the risk of air embolus All entrapped air must be removed from the device blood pumping chamber and conduits prior to fully releasing the sealed Outflow Graft cross clamp At least one System Controller power cable must be connected to a power source Power Module Mobile Power Unit or two HeartMate 14 Volt Lithium I...

Page 240: ...te ICD therapy The occurrence of electromagnetic interference with ICD sensing may require adjustment of device sensitivity and or repositioning the lead Initial weaning of cardiopulmonary bypass should ensure a minimum of two liters per minute lpm of blood flow to the Left Ventricular Assist Device to prevent air embolism Prolonged de airing may be due to inadequate blood supply to the Left Ventr...

Page 241: ... the apical Coring Knife to involve the interventricular septum while performing left ventricle coring The sealed Outflow Graft and Pump Cable must not be kinked or positioned where it could abrade against a Pump component surgical element or body structure Remove all vents on the inflow side of the Left Ventricular Assist Device including needles in the pulmonary vein left atrium and left ventric...

Page 242: ... Driveline interference with clothing or belts 5 Insert the pointed tip of the tunneler into a small incision appropriately positioned on the inner abdominal wall 6 Starting from the inferior aspect of the pocket create a long and gently curved tunnel that passes through the right rectus abdominis and subcutaneous tissue to an exit site in the upper right quadrant 7 Prior to exiting the dermis pla...

Page 243: ...kin or velour skin interface at the exit site 17 Place the prepared Pump into the prepared space Attaching the Sealed Outflow Graft to the Aorta FOR THIS TASK YOU NEED 1 sealed Outflow Graft with bend relief TO ATTACH THE SEALED OUTFLOW GRAFT 1 Confirm that the bend relief is added to the sealed Outflow Graft prior to attaching it to the aorta with the thread protector on the graft 2 Place the Pum...

Page 244: ...ose the coring location slightly anterior to the apex a few centimeters lateral to the left anterior descending coronary artery 3 Ensure that the metal skeletal structure is facing away from the myocardium and that the black markings are visible on the Apical Cuff CAUTION After the Apical Cuff has been sewn to the heart the metal ring on the Apical Cuff should extend above the felt surface to allo...

Page 245: ... the myocardial tissue and the Apical Cuff felt is required b Approximately one and a half centimeters from the core suture the sewing ring cuff with at least 12 pledgeted horizontal mattress 2 0 braided sutures almost full thickness c Apply corresponding sutures to the felt sewing cuff Figure 5 28 Placement of Sutures Between the Metal Ring and the Circumferential Line on the Apical Cuff 5 Ensure...

Page 246: ...ered for approximation of epicardium and felt and hemostasis Figure 5 29 Suturing Resulting in an Apical Cuff Without Protruding Myocardial Tissue 7 Complete the following steps to gather the myocardium around the felt cuff a Separate the sutures b Tie the sutures tight with 6 to 7 throws on each knot 8 Complete the following steps when sewing the Apical Cuff to the exterior of the heart a Ensure ...

Page 247: ...ricular cavity is entered Figure 5 30 b Align the orientation of the Coring Knife toward the mitral valve c Take care to avoid orienting the inlet towards the interventricular septum Pump function will be compromised in the presence of inlet obstruction Figure 5 30 Coring Ventricular Apex 10 Complete the following steps a Remove the core and inspect the ventricular chamber for mural thrombi and cr...

Page 248: ...the Coring Knife into the heart as described in Steps 9 and 10 in the Sew Then Cut Method section Inserting the Pump in the Ventricle FOR THIS TASK YOU NEED 1 Pump with Thread Protector Installed TO INSERT THE PUMP IN THE VENTRICLE Carefully perform the following steps to ensure proper placement of the Pump and Inflow Cannula 1 Remove glove tip 2 Retract the Slide Lock so that it is in the fully o...

Page 249: ...d the Pump Cable is oriented toward the midline Figure 5 32 Figure 5 32 Inserting Inflow Cannula and Rotating Pump 5 When the Inflow is inserted into the ventricle ensure that the thread protector is secure and the luer fitting is tight to prevent air entrainment 6 Push the Slide Lock on the Pump inward to engage and lock the Pump into position Figure 5 33 Figure 5 33 Pushing the Slide Lock Inward...

Page 250: ...tracted 9 Inspect the entire circumference of the Pump cuff junction to ensure that the LVAD is properly seated The Slide Lock with the exception of the tab will be fully inserted and no yellow zone is visible 10 If the yellow zone is visible fully retract the Slide Lock and repeat Steps 4 6 11 Position the heart and Pump in the position that will be expected upon chest closure 12 If the orientati...

Page 251: ... Pump and the Outflow Graft 2 Using the Screw Ring turn the ring clockwise to attach the Outflow Graft to the Pump Cover Figure 5 34 There is a clicking sound as the Screw Ring is tightened This is normal Figure 5 34 Attaching the Graft 3 Continue turning the ring clockwise until it comes to a complete stop and stops clicking 4 Verify that the graft is not twisted or kinked as follows Check the po...

Page 252: ...hat an arch forms the highest point 4 Insert a vent needle at the highest point in the graft between the clamp and the sealed Outflow Graft connection 5 Reduce cardiopulmonary bypass flow to allow filling of the left ventricle and Left Ventricular Assist Device by diverting at least two liters per minute lpm of blood to the ventricle 6 Connect the Pump Cable connector to the Modular Cable to initi...

Page 253: ...e 5 35 Clinical Screen Initial Pump Startup 8 If the speed setpoint is not 3 000 rpm complete the following steps a On the System Monitor press the Settings tab b Press the Fixed Speed Adjust button c Follow the on screen instructions to set the speed to 3 000 rpm IMPORTANT The needle vent should be placed in the sealed Outflow Graft in the highest point in the lumen anterior side to optimize air ...

Page 254: ...itor when the Pump is running The Pump Flow box displays when any of the following occur The Pump is stopped The Driveline is disconnected Communication Fault The estimated pump flow is outside the expected operational range less than 4000 rpm AND a Pulse Index greater than 9 0 Figure 5 36 Clinical Screen During Initial Pump Startup typical Figure 5 37 Settings Screen During Initial Pump Startup t...

Page 255: ...the metal fitting of the sealed Outflow Graft toward the locking screw ring until it engages into place 17 Confirm that the Bend Relief is fully connected and seated to the sealed Outflow Graft by completing the following steps a Visually inspect the Bend Relief Figure 5 38 Note The HeartMate III LVAD may create electromagnetic interference with ECG monitoring Adjustment of ECG lead placement may ...

Page 256: ...o the Pump 19 Terminate cardiopulmonary bypass to provide ample blood flow to the Left Ventricular Assist Device The goal at this time is to achieve and maintain appropriate flow levels by adjusting the Fixed Speed of the Pump 20 Monitor flow the LV size position of the septum and aortic valve opening to determine the appropriate Fixed Speed setting The final decision is ultimately dependent on th...

Page 257: ...ce across the Pump of 80 10 70 mmHg a Pump running at the same speed would flow 3 lpm By increasing the speed to 6 000 rpm the same 70 mmHg pressure difference across the Pump would result in a 6 lpm pump flow This relationship demonstrates that the flow generated by the Pump is directly related to the pressure difference across the Pump and heavily dependent upon left ventricular pressure Figure ...

Page 258: ... recommended to verify the Pump is running Securing the Pump and Connections When the flow through the blood Pump is satisfactory ensure that the sealed outflow connections are dry and secure Obtain hemostasis and close all wounds in the standard fashion Prior to leaving the operating room immobilize the Driveline and System Controller CAUTION Care should be taken to ensure that the sealed Outflow...

Page 259: ... ICU complete the following steps a Return to Power Module power b Go to the Alarms screen and verify the alarm silence is off As a reminder that the backup battery needs to be installed a yellow wrench flashes and a graphic is displayed on the System Controller Refer to System Controller Backup Battery Not Installed Alarm on page 7 22 5 Install the Backup Battery in the backup System Controller R...

Page 260: ...ckup battery leaks do not touch the leaking fluid If the fluid touches skin or eyes wash the affected area with plenty of water and seek medical advice To prevent deterioration or damage to an 11 Volt Lithium Ion backup battery Store within approved temperatures 59 F to 77 F 15 C to 25 C Do not use in temperatures that are below 32 F 0 C or above 104 F 40 C or the battery may fail suddenly Do not ...

Page 261: ...rewdriver to loosen the four battery cover screws included with 11 Volt Lithium Ion backup battery 1 spare screw cover included with 11 Volt Lithium Ion backup battery TO INSTALL THE BACKUP BATTERY IN THE SYSTEM CONTROLLER 1 Use the lever to lift up the screw cover Figure 5 41 Figure 5 41 Using the Lever to Lift up the Cover 2 Use the screwdriver to loosen the four captive screws on the battery co...

Page 262: ... battery inside the battery compartment Figure 5 44 Figure 5 44 Placing the Battery Inside the Compartment 8 Place the cover over the battery compartment 9 Use the screwdriver to tighten the four screws Do not over tighten the screws 10 Replace the screw cover 11 Install the backup battery in the patient s backup System Controller by following steps 1 10 IMPORTANT Be aware that installing an 11 Vo...

Page 263: ...ass and establish flow 3 Disconnect power from the System Controller and then disconnect the in line connection to stop pumping 4 Cross clamp the sealed Outflow Graft just distal to the bend relief and divide the graft 5 Expose the Slide Lock mechanism and pull it radially to disengage the Pump from the Apical Cuff 6 Disengage the Pump from the ventricle 7 Repair or plug the ventricle as necessary...

Page 264: ...hest pocket and remove the remaining portion of the Pump Cable from the inside out by careful dissection 11 Close the site in standard fashion 12 Remove the sealed Outflow Graft remnant from the aorta and repair the anastomotic site 13 If returning the device to Thoratec Corporation for disposal use the HeartMate Explant Kit ...

Page 265: ...e patient care Postoperative Patient Care 6 3 Ongoing Patient Assessment and Care 6 7 Important Clinical Considerations for HeartMate III Patients 6 10 Educating and Training Patients Families and Caregivers 6 12 Ongoing System Assessment and Care 6 14 Showering 6 17 Preparing for Sleep 6 29 Wearing and Carrying System Components 6 30 ...

Page 266: ...6 Patient Care and Management 6 2 HeartMate III Left Ventricular Assist System Instructions for Use ...

Page 267: ...sers including clinicians patients and caregivers must be trained on their use Certain parts of the HeartMate III Left Ventricular Assist System are not compatible with other HeartMate systems such as the HeartMate II Left Ventricular Assist System Only use HeartMate III parts with the HeartMate III system If the Pump loses external power it may stop If the Pump stops connect to external power imm...

Page 268: ...ticoagulation regimens are contraindicated during pregnancy Do not subject patients implanted with the HeartMate III Left Ventricular Assist System to Magnetic Resonance Imaging MRI as the device contains Ferromagnetic components MRI can cause Pump failure or patient injury Keep patients away from the RF shielded room of MRI suites Therapeutic radiation such as tissue heating therapy using Radio F...

Page 269: ...oratec Corporation Notify the appropriate personnel if there is a change in how the Pump works sounds or feels Counsel the patient to avoid contact sports and jumping activities while implanted with the Pump Contact sports or jumping can cause bleeding or damage the Pump The Driveline exit site must be dressed prior to applying stabilization To achieve the desired outcome stabilization should be a...

Page 270: ...ndled Do not place objects other than the HeartMate III system components into the wearable accessories Placing objects other than HeartMate III components into a wearable accessory may damage the wearable accessory During showers use care to keep the exit site as clean and dry as possible Also avoid pulling on or moving the Driveline during a shower Position the Shower Bag so that it will not pul...

Page 271: ...troller Driveline Connector Safety Lock is in the locked position Modular connector is properly connected and locked Exit site status immobilization of Driveline Vital signs peripheral circulation Mental status level of consciousness 12 lead EKG ECHO Potential Risks and Adverse Events Hypovolemia Right heart failure Pulmonary hypertension Cardiac tamponade Bleeding Arrhythmia Infection Hemolysis T...

Page 272: ...gal infection However no clinical trials have been conducted to verify the efficacy of anti fungal prophylaxis Controlling Infection Infection among implantable Left Ventricular Assist Device patients is common especially in patients with multi system organ failure who require prolonged stays in the ICU Infection rates can be minimized however by applying the following approaches to patient manage...

Page 273: ... and titrate to PTT 55 65 1 5 1 8 times control 4 On postoperative day 2 3 initiate aspirin 81 100 mg QD 5 On postoperative day 3 5 when there is no evidence of bleeding and the chest tubes have been removed complete the following steps a Begin warfarin overlapping with the heparin b Discontinue heparin after obtaining an acceptable stable INR The INR should be maintained in the range of 2 0 3 0 6...

Page 274: ...age the Outflow Graft or dislodge the Left Ventricular Assist Device inflow Cardiac massage under direct vision performed by a skilled surgeon may be effective in patients who have had recent Pump implantation prior to mediastinal healing Defibrillation Blood Leak Diagnosis A blood leak from any implanted component of the system is typically identified through one of the following symptoms Unexpla...

Page 275: ... than 30 High levels of static electricity may damage and or interfere with the electrical parts of the system and cause the Left Ventricular Assist Device to stop Advise the patient to Avoid activities that may cause static electricity Discharge any built up ESD by touching a metal surface before handling LVAS components Implantable Defibrillators or Pacemakers WARNING Prior to implanting an impl...

Page 276: ...systems Concept of ventricular assistance How the Left Ventricular Assist Device pumps blood Control modes Battery powered versus Mobile Power Unit operation Battery use regimen Advisory and Hazard alarms including their meaning and how to recognize and respond to them Medical Alert ID Bracelet recommended Maintenance and periodic safety checks Daily weekly monthly six month and yearly safety chec...

Page 277: ...gency What is an emergency clinical emergency versus equipment emergency Steps to take in an emergency Emergency transportation plan Preparing for and practicing emergency procedures How to diagnose power or connector problems Emergency telephone contacts Replacing the running System Controller with the backup System Controller 7 Driveline Exit Site Management 8 Showering 9 Preparing for sleep 10 ...

Page 278: ...5 for information about caring for the Driveline Do not pull on or move the Driveline going through the skin When checking to ensure that the Driveline connector is fully inserted into the System Controller Driveline socket gently tug on the metal end of the connector Do not move or pull on the Driveline Check that the Modular In line Connector is properly connected and that the lock is secured Be...

Page 279: ...ights and sounds to indicate how it is working If the patient has trouble hearing or seeing he or she may need extra help to hear or see the lights and sounds To avoid pulling on or moving the Driveline at the exit site the patient must stabilize their Driveline at all times Pulling on or moving the Driveline can keep the exit site from healing or damage an already healed exit site Exit site traum...

Page 280: ... damage Routinely reinforce the importance of adhering to the following guidelines for power cable care Do not kink or sharply bend the power cables especially near the strain relief portion of the System Controller connectors where the connector and cable meet Figure 6 1 Avoid repeated bending of the power cables especially near the connectors When carrying the System Controller in a bag case or ...

Page 281: ...ystem Controller batteries Power Module or Mobile Power Unit to water If these system components get wet the Pump may stop Never take tub baths or go swimming while implanted with the Pump The HeartMate GoGear Shower Bag must be used while showering to keep the System Controller and batteries dry CAUTION Do not take a shower until your doctor says you can Refer to the HeartMate III Left Ventricula...

Page 282: ... Sealing Wrap Centered Over the Driveline Management System b Press the sheet of multi purpose sealing wrap into place with fingers so that it is smooth to the skin with no gaps c If needed ask for help 3 Complete the following steps to seal around the edges of the multi purpose sealing wrap Figure 6 3 a Apply the tape to all four edges of the sheet of multi purpose sealing wrap so that there are ...

Page 283: ...utside of the multi purpose sealing wrap 2 Gently peel away the multi purpose sealing wrap and tape from the skin Figure 6 4 As the wrap is removed be careful to not disturb the driveline management system Figure 6 4 Multi Purpose Sealing Wrap and Tape Gently Peel Away From Skin 3 If the driveline management system gets wet change it as instructed in the previous sections ...

Page 284: ...is outside in heavy rain or snow and always for every shower If the external system components have contact with water or moisture the patient may receive a serious electric shock or the Pump may stop When taking a shower the patient must shield all external components from water by placing them into the water resistant Shower Bag This includes protecting the System Controller System Controller po...

Page 285: ... Shower Bag has an adjustable shoulder strap for optimal positioning to reduce pulling on the Driveline exit site The Shower Bag also incorporates two loops and a belt It can be worn around the waist to further secure the bag to the patient s body Two belt loops one on each side of the bag allow the bag and belt to be worn on either the patient s right or left side Figure 6 6 shows the Shower Bag ...

Page 286: ...can keep the exit site from healing or damage an already healed exit site Exit site trauma or tissue damage can increase the patient s risk of getting a serious infection Emphasize to the patient and or family member or caregiver the importance of not pulling on or moving the Driveline Do not twist kink or sharply bend the Driveline the System Controller power cables the Power Module patient cable...

Page 287: ...top of the bag Figure 6 7 Figure 6 7 Attaching the Shoulder Strap 2 Slide the belt through the loop on the side of the bag that will be against the patient s body to attach the clip style belt Figure 6 8 The Shower Bag can be worn on a patient s left or right side depending on the selected belt loop Figure 6 8 Attaching the Optional Belt 3 Adjust the shoulder strap so that the Shower Bag fits the ...

Page 288: ...wer TO WEAR THE SHOWER BAG 1 Gather the Shower Bag and System Controller on battery power and place both within reach 2 Ensure that the System Controller power cables and Driveline are not twisted Figure 6 9 Figure 6 9 Power Cables and Driveline Not Twisted 3 Unclip the lid of the Shower Bag by squeezing the clip prongs together and then pulling the slide out of the buckle Figure 6 10 Figure 6 10 ...

Page 289: ...k the Shower Bag lid to reveal the double zipper Figure 6 11 Figure 6 11 Removing the Shower Bag Lid 5 Unzip and open the cover of the water resistant enclosure 6 Place the batteries battery clips and attached power cables into the Shower Bag Figure 6 12 Figure 6 12 Batteries and Battery Clips in the Shower Bag ...

Page 290: ... should be facing up 7 Slide the System Controller into the pocket on the inside cover of the bag 8 Position the power cables inside the water resistant enclosure Figure 6 13 Figure 6 13 Power Cables Inside the Bag 9 Close and zip the cover 10 Ensure that the System Controller power cables are inside the Shower Bag and that the Driveline exits through the protective red tabs Figure 6 14 Figure 6 1...

Page 291: ...ace Figure 6 16 Figure 6 16 Clip Snapped Into the Buckle to Secure the Shower Bag Lid 13 Use the Shower Bag strap to hang the Shower Bag over the patient s head and shoulder so the Shower Bag hangs at his or her side 14 Clip the belt around the patient s waist The belt secures the Shower Bag and prevents it from dropping if it slips from the patient s shoulder It also keeps the Shower Bag from swi...

Page 292: ... a sterile dressing to the exit site using a sterile technique Refer to Caring for the Drive line Exit Site on page 6 8 7 Use a clean dry towel to dry the Shower Bag s exterior and strap 8 Open the Shower Bag using the clip and buckle for the lid and the left and right zippers for the top 9 Remove all equipment from the Shower Bag enclosure 10 Place the equipment in a clean dry location 11 Transfe...

Page 293: ...eration the low battery alarms may not awaken the patient before battery depletion Prior to sleep inspect and ensure that all electrical connections are secure A patient should not sleep on his or her stomach Keep the replacement System Controller nearby for convenient access in the event of an emergency that requires replacement of the running System Controller Keep a flashlight fully charged bat...

Page 294: ...ivities and any changes in activity level or routine Table 6 1 describes the wear and carry accessories Table 6 1 Wear and Carry Accessories System Controller Neck Strap Use the System Controller Neck Strap to wear the System Controller around the neck or across the body The System Controller Neck Strap attaches to the System Controller when the System Controller is connected to the Power Module t...

Page 295: ...is designed to distribute equipment weight across the shoulders and back The Holster Vest includes a chest strap and works with or without the Belt Attachment The Holster Vest holds the System Controller and two HeartMate 14 Volt Lithium Ion batteries and attached battery clips during battery powered operation Protection Bag Use the Protection Bag to store and protect the backup System Controller ...

Page 296: ... Assist System Instructions for Use Using the System Controller Neck Strap The System Controller Neck Strap Figure 6 17 can be worn around the neck or across the body It attaches to the System Controller with two small straps Figure 6 17 System Controller Neck Strap ...

Page 297: ...ontroller Use one pair of attachment points to suspend the System Controller either vertically or horizontally Figure 6 19 Figure 6 19 System Controller Suspended on the Neck Strap Horizontally left and Vertically right FOR THIS TASK YOU NEED 1 running System Controller 1 System Controller Neck Strap TO ATTACH AND WEAR THE SYSTEM CONTROLLER NECK STRAP 1 Gather the equipment and place within reach ...

Page 298: ... Driveline are not twisted Figure 6 20 Figure 6 20 Power Cables and Driveline 4 Choose two attachment points on the System Controller for either vertical or horizontal wearing of the Neck Strap 5 Slide the rubber strap on the Neck Strap through an attachment point on the System Controller Figure 6 21 Figure 6 21 Rubber Strap Through the Attachment Point ...

Page 299: ...ed to the System Controller Figure 6 23 Figure 6 23 Tug on the Strap 8 Repeat Step 5 through Step 7 to attach the other end of the Neck Strap to the second attachment point on the System Controller 9 Place the Neck Strap around the patient s neck so that the System Controller is located either on the patient s chest or on the left or right side of the patient 10 Adjust the length of the Neck Strap...

Page 300: ...cessory Figure 6 24 is similar to accessories that are used to wear or carry a cell phone The Belt Attachment can be attached to the patient s belt or to the provided nylon clip belt Figure 6 24 Wearing the Belt Attachment FOR THIS TASK YOU NEED 1 running System Controller 1 Belt Attachment 1 personal belt up to 2 wide or 1 provided nylon clip belt ...

Page 301: ...ure 6 25 Figure 6 25 Power Cables and Driveline 3 Slide either the patient s belt or the provided nylon belt through the loop on the back of the Belt Attachment Figure 6 26 Figure 6 26 Belt Through the Loop on Belt Attachment 4 Unclip the two banded strap on the Belt Attachment 5 Slide the System Controller the end without the cable first into the Belt Attachment with the display screen facing out...

Page 302: ... cable connector and the Driveline connector Figure 6 28 Figure 6 28 Place the Strap Between the Connectors 7 Clip the two banded strap into place and ensure that both prongs are fully engaged in the clip Figure 6 29 Figure 6 29 Clip the Strap Into Place 8 Fasten the belt and Belt Attachment around the patient s waist 9 Adjust and tighten the belt as necessary until it is secure but still comforta...

Page 303: ...a Unclip the nylon clip belt b Remove the Belt Attachment System Controller and belt from around the patient s waist c Place the Belt Attachment System Controller and belt on a stable surface d Go to Step 5 4 Complete the following steps to remove the Belt Attachment from the patient s belt a Unfasten the belt b Slide the Belt Attachment off the belt c Place the Belt Attachment and System Controll...

Page 304: ... 6 30 is a slim profile shoulder bag It allows HeartMate patients to comfortably and securely wear and carry system components together in a single bag while using batteries Figure 6 30 Consolidated Bag The Consolidated Bag can be worn across the body using a shoulder strap and supported at the waist using a waist strap Red Protective Tabs Shoulder Strap ...

Page 305: ...onsolidated Bag allows the patient to view the System Controller s user interface The user interface is visible through a transparent panel beneath a small hook and loop fastener flap on the outside of the bag The Consolidated Bag is available in one color black and two configurations depending upon the placement of the patient s Driveline exit site One configuration for wearing on the right side ...

Page 306: ...cated on the top of the Consolidated Bag Figure 6 32 Figure 6 32 Attaching the Strap to the Consolidated Bag 3 Confirm which side left or right the Consolidated Bag is meant to be worn on by the patient 4 Put the bag on the patient to confirm the appropriate placement on the left or right side IMPORTANT The bag type left or right can be found on a tag inside the Consolidated Bag and on the box tha...

Page 307: ...place within reach 2 Ensure that the System Controller power cables and Driveline are not twisted Figure 6 33 Figure 6 33 Power Cables and Driveline 3 Unzip both Consolidated Bag zippers to open 4 Slide the System Controller into its holder so the user interface faces out Figure 6 34 Figure 6 34 System Controller in the Holder in the Consolidated Bag 5 Stretch the two banded strap over the System ...

Page 308: ...ructions for Use 6 Fasten the clip to hold the System Controller in place Figure 6 35 Figure 6 35 Strap Over the System Controller and Between the Cables 7 Place one battery into the Consolidated Bag with the battery clip and cable facing out Figure 6 36 Figure 6 36 Battery in the Bag ...

Page 309: ...cable for the battery and battery clip so that the cable lays flat along the edge of the bag Figure 6 37 Figure 6 37 Arranging the Cables Around the Edge of the Bag 9 Place the second battery into the Consolidated Bag with the battery clip and cable facing out Figure 6 38 Figure 6 38 Placing the Second Battery in the Bag ...

Page 310: ...he edge of the bag Figure 6 39 Figure 6 39 Batteries and Cables in Consolidated Bag 11 Carefully close the Consolidated Bag 12 Ensure that The System Controller power cables are inside the Consolidated Bag The Driveline exits the Consolidated Bag between the protective red tabs Figure 6 40 Figure 6 40 Closing the Bag Driveline Exits Between the Red Tabs ...

Page 311: ...place The belt stabilizes the bag and prevents it from moving Removing the Consolidated Bag TO REMOVE THE CONSOLIDATED BAG 1 Unclip the belt 2 Hold the Consolidated Bag using the handle so it does not drop 3 Remove the shoulder strap Either unclip it at one side or lift it up and over the patient s head 4 Remove the Consolidated Bag and place it in front of the patient 5 Unzip and open the Consoli...

Page 312: ...attery clips System Controller during battery powered operation This wearable accessory is designed to secure the batteries and battery clips in holsters with the weight of the system components distributed across the patient s shoulders and back The Belt Attachment is designed to conceal and carry the System Controller The Battery Holster is available in one size and is adjustable to accommodate ...

Page 313: ...ters should fit securely but comfortably against the patient s sides and under the arms 5 After determining the appropriate fit cut off or trim the extra length from the end of each strap Note Extra strap length can be used later for further adjustment should the patient gain weight 6 Apply a strong epoxy glue to the cut off ends of each strap to reduce fraying 7 Allow the glue to dry before weari...

Page 314: ...ce within reach 2 Ensure that the System Controller power cables and Driveline are not twisted Figure 6 43 Figure 6 43 Power Cables and Driveline 3 Complete the following steps to insert the batteries and attached battery clips into each holster a Open each hook and loop fastener flap on the Battery Holster Figure 6 44 Figure 6 44 Hook and Loop Fastener Flap ...

Page 315: ...t put on the Battery Holster 5 Put on and secure the Belt Attachment around the patient s waist 6 Adjust and tighten the belt as needed until it is secure but still comfortable 7 Slide the System Controller into the Belt Attachment 8 Stretch the two banded strap on the Belt Attachment over the end of the System Controller and between the white System Controller power cable connector and the Drivel...

Page 316: ...ery clip and put the depleted battery aside A Power Cable Disconnect advisory will sound This is normal 6 Retrieve one of the fully charged batteries and insert it into the battery clip The battery clicks into place when fully inserted The alarm stops when the fully charged battery is properly inserted 7 Place the fully charged battery and attached battery clip into the empty holster 8 Close the B...

Page 317: ...omplete the following steps to remove the Battery Holster from the nylon clip belt a Unclip the nylon clip belt b Remove the Belt Attachment System Controller and belt from around the patient s waist c Place the Belt Attachment System Controller and belt on a stable surface d Go to Step 7 6 Complete the following steps to remove the Battery Holster from the patient s belt a Unfasten the belt b Sli...

Page 318: ...tteries on page 3 46 Figure 6 47 Holster Vest The Holster Vest is designed to distribute the weight of the HeartMate III system components across the patient s shoulders and back with holsters for the batteries and an optional chest strap The Holster Vest is available in three sizes small medium and large A Belt Attachment cover is provided to conceal protect and wear the System Controller with th...

Page 319: ...p through the slot in the top of one of the holsters The buckle should point down and the holster should face forward when the patient wears the Holster Vest Figure 6 48 Figure 6 48 Holster Vest Strap Through Slot in Top of the Holster 3 Repeat Step 2 for the second holster Wearing the Holster Vest FOR THIS TASK YOU NEED 1 running System Controller on Power Module or Mobile Power Unit power 1 asse...

Page 320: ... Controller power cables and Driveline are not twisted Figure 6 49 Figure 6 49 Power Cables and Driveline 3 Complete the following steps to place the batteries and attached battery clips into the holsters a Insert one battery and attached battery clip into the holster The clip point should point up and the battery should point down Figure 6 50 Figure 6 50 Inserting Battery and Clip into Holster ...

Page 321: ... and comfortable 7 Complete the following Belt Attachment steps a Secure the Belt Attachment around the patient s waist b Adjust and tighten the belt until it is secure but still comfortable c Slide the System Controller into the Belt Attachment d Stretch the two banded strap on the Belt Attachment over the end of the System Controller and between the white System Controller power cable connector ...

Page 322: ...the hook and loop fastener tabs on the back of the holsters to hold the power cables in place and to stabilize the holsters Figure 6 52 Figure 6 52 Hook and Loop Fastener Tabs Hold the Power Cables in Place 10 Put the patient s belt through the hook and loop fastener tabs to help secure the holsters in place ...

Page 323: ...epleted battery while pressing the battery release button on the battery clip 4 Withdraw the depleted battery from its battery clip An alarm will sound when the battery is removed This is normal 5 Retrieve one of the fully charged batteries and insert it into the empty battery clip The battery clicks into place when fully inserted The alarm stops when the battery is inserted 6 Close the flap on th...

Page 324: ...6 Patient Care and Management 6 60 HeartMate III Left Ventricular Assist System Instructions for Use 8 Recharge the depleted batteries Refer to Charging HeartMate Batteries on page 3 72 ...

Page 325: ...lip belt b Remove the Belt Attachment System Controller and belt from around the patient s waist c Place the Belt Attachment System Controller and belt on a stable surface d Go to Step 7 6 Complete the following steps if the patient is wearing his or her own belt a Unfasten the belt b Slide the Belt Attachment and System Controller off the belt c Place the Belt Attachment and System Controller on ...

Page 326: ...ag 2 Slide the backup System Controller into the Protection Bag 3 Carefully coil the cables around the System Controller inside the Protection Bag 4 Zip close the Protection Bag Figure 6 54 Figure 6 54 Protection Bag with Backup Controller and Cables Stored Inside IMPORTANT When placing the System Controller inside the Protection Bag do not twist kink or sharply bend the System Controller power ca...

Page 327: ...pare batteries The Travel Bag provides a convenient way to carry and transport the backup System Controller and spare batteries The Travel Bag can also be used at home to hold the backup System Controller Figure 6 55 Figure 6 55 Travel Bag FOR THIS TASK YOU NEED 1 Protection Bag with backup System Controller and cables stored inside 2 spare fully charged 14 Volt Lithium Ion batteries 1 Travel Bag ...

Page 328: ...e Travel Bag 3 Place the Protection Bag with the backup System Controller and cables inside into the Travel Bag Figure 6 56 Figure 6 56 Inserting Protection Bag Into Travel Bag 4 Place the fully charged spare batteries into the side pockets of the Travel Bag Figure 6 57 Figure 6 57 Inserting Spare Batteries Into Travel Bag 5 Zip close the inner compartment and snap shut the top lid ...

Page 329: ...arms and troubleshooting of the HeartMate III Left Ventricular Assist System System Controller Alarms 7 3 System Monitor Alarms 7 25 Handling Power Module Alarms 7 29 Mobile Power Unit Alarms 7 32 Using the Charger to Check Battery or Charger Status 7 33 Guidelines for Power Cable Connectors 7 36 What Not to Do Driveline and Cables 7 37 ...

Page 330: ...7 Alarms and Troubleshooting 7 2 HeartMate III Left Ventricular Assist System Instructions for Use ...

Page 331: ...s Handling System Controller Alarms Common System Controller alarms are described on the following pages Each section addresses the likely cause and typical steps for resolving most System Controller alarms Alarms are presented in order of priority Hazard alarms appear first followed by Advisories Refer to Table 7 2 through Table 7 3 on the following pages for a complete list of prioritized System...

Page 332: ...tem Controller a history of all alarms is available through the System Monitor Refer to System Controller Event Recorder on page 4 33 To view the six most recent alarms on the user interface screen simultaneously press and release the silence alarm and display buttons Up to six of the most recent alarms are displayed The most recent alarm appears first To view the next alarm press and release the ...

Page 333: ...played Example Press Press display button and silence alarm button at the same time to access first alarm Press Press display button ONCE to display the second alarm Press Press display button TWO times to display the third alarm Press Press display button THREE times to display the fourth alarm Press Press display button FOUR times to display the fifth alarm Press Press display button FIVE times ...

Page 334: ...user interface screen until the alarm condition is resolved or permanently disabled and therefore do not appear in alarm history In addition a Power Cable Disconnect advisory alarm that lasts less than 30 seconds and Pulsatility Index PI events are examples of routine events that might interfere with access to more critical information For this reason these events also do not appear in alarm histo...

Page 335: ... System Controller to the locked position If alarm persists after reconnecting the Driveline press any button on the System Controller to attempt Pump start Also check that the Modular In Line Connector is secure Otherwise check if the Fixed Speed setting is below 4 000 rpm AND the System Controller s backup battery is not installed Under these conditions the Pump can only be started from the Syst...

Page 336: ...ged HeartMate 14 Volt Lithium Ion batteries Ensure the power cables are connected correctly white to white and black to black Note The second condition meaning resolution will not apply for Mobile Power Units with software version 1 02 Refer to page 7 17 4 hours System Controller Hardware Fault 1 Switch to the backup System Controller 2 Provide patient with a new System Controller Refer to page 7 ...

Page 337: ...ttery does not resolve the alarm the System Controller may need to be replaced or additional steps may be required Call Thoratec Corporation with questions Refer to page 7 22 4 hours Driveline Power Fault Contact Thoratec Corporation to determine best next steps Use the System Monitor to silence the alarm while awaiting resolution if needed Note The alarm must be active in order to access the alar...

Page 338: ...to a power source if disconnected failed If restoring power does not resolve patient should press any button on the System Controller to attempt Pump start and immediately call hospital contact for diagnosis and instructions Clinicians 1 Check if the Fixed Speed setting is below 4000 rpm AND the System Controller s backup battery is not installed Under these conditions the Pump can only be started...

Page 339: ... screen Alarm tone Constant tone System Monitor alarm active LOW FLOW Alarm means Pump flow is less than 2 5 lpm To resolve alarm Patients must call their hospital contact immediately for diagnosis and instructions Clinicians should 1 Ensure the Driveline is connected to the System Controller Refer to page 2 21 2 Ensure that a power source is connected to the System Controller 3 Clinically evaluat...

Page 340: ...t the Driveline to the System Controller and move the Driveline Safety Lock on the System Controller to the locked position Refer to page 2 21 2 If alarm persists after reconnecting the Driveline press any button on the System Controller to attempt Pump start Also check that the Modular In Line Connector is secure Otherwise check if the Fixed Speed setting is below 4 000 rpm AND the System Control...

Page 341: ...s Table 7 5 No External Power Alarm This is a Hazard alarm The screens look like this alternating screens Behavior and appearance Flashing Red Battery on the user interface Connect Power Immediately and Backup Battery graphic alternate on the screen Yellow light near the black power cable connector is flashing Yellow light near the white power cable connector is flashing Alarm tone Constant tone S...

Page 342: ...ower Immediately alternate on the screen Alarm tone Constant tone System Monitor alarm active LOW VOLTAGE Alarm means Less than 5 minutes of battery power remains when using battery power OR The System Controller is receiving inadequate power from the Power Module or Mobile Power Unit To resolve alarm Immediately connect to a working or different power source Power Module Mobile Power Unit or two ...

Page 343: ...en The Driveline is connected and power is connected Alarm tone Constant tone All Controller buttons are non functional No System Monitor communication alarm will not appear on the System Monitor Alarm means The microcontroller inside the System Controller is not functioning Power is passing directly from the source through the System Controller to the Pump The Pump will continue to operate as lon...

Page 344: ...onnected Connect Power displays on the screen Alarm tone Fast beep System Monitor alarm active Power Cable Disconnect Alarm means One of the System Controller power cables is disconnected from power If it is the cable with the black connector the top light comes on If it is the cable with the white connector the center light comes on To resolve alarm Promptly connect the disconnected power cable t...

Page 345: ...terface Low Battery and Replace Power alternate on the screen Alarm tone Slow beep System Monitor alarm active Low Voltage Advisory Alarm means Low voltage power input to the System Controller is low with less than 15 minutes of battery power remaining OR System Controller power cables are crossed when connected to the Mobile Power Unit Note The second condition crossed power cables will not apply...

Page 346: ...that the power cables are connected correctly white to white and black to black 3 If reconnecting to the Mobile Power Unit does not resolve the alarm promptly connect to a different power source Refer to Connecting to the Mobile Power Unit on page 3 42 Note This alarm and resolution will not apply for Mobile Power Units with software version 1 02 ...

Page 347: ...m Controller Fault Alarm This is an Advisory alarm The screens look like this Behavior and appearance Flashing yellow wrench on the user interface Call Hospital Contact displays on the screen Alarm tone Slow beep System Monitor alarm active Replace System Controller Alarm means An internal malfunction in the System Controller has occurred that requires clinician diagnosis and resolution To resolve...

Page 348: ...eline are not functioning To resolve alarm Patients must call their hospital contact immediately for diagnosis and instructions Clinicians should 1 Contact Thoratec Corporation to determine best next steps 2 Use the System Monitor to silence the alarm while awaiting resolution if needed Alarm silence period 4 hours or until any new alarm occurs To silence this alarm press the Silence Alarm button ...

Page 349: ...active Replace Backup Battery Alarm means The System Controller s 11 Volt Lithium Ion backup battery is compromised OR It is unable to fully support Pump function OR There is an issue that requires clinician diagnosis and resolution To resolve alarm Patients must call their hospital contact immediately for diagnosis and instructions Clinicians should replace the System Controller 11 Volt Lithium I...

Page 350: ... means The System Controller s11 Volt Lithium Ion backup battery is not installed OR It is installed incorrectly To resolve alarm Patients must call their hospital contact immediately for diagnosis and instructions Clinicians should 1 Install the 11 Volt Lithium Ion backup battery in the System Controller Refer to Replacing a Backup Battery on page 2 37 2 Obtain a new 11 Volt Lithium Ion backup ba...

Page 351: ...nstructions Clinicians should 1 Contact Thoratec to determine best next steps 2 Use the System Monitor to silence the alarm while awaiting resolution if needed Note The alarm must be active in order to access the alarm silence for this situation Alarm silence period 4 hours or until any new alarm occurs To silence this alarm press the Silence Alarm button In addition it can be permanently silenced...

Page 352: ...spital contact immediately for diagnosis and instructions Clinicians should 1 Contact Thoratec Corporation to determine best next steps 2 Use the System Monitor to silence the alarm while awaiting resolution if needed Note The alarm must be active to access the alarm silence for this situation Alarm silence period 4 hours or until any new alarm occurs To silence this alarm press the Silence Alarm ...

Page 353: ...or Screen To Resolve Alarm A D V I S O R Y Warning Low Speed Advisory 1 Use the System Monitor to check that the fixed speed and low speed limit have been appropriately set 2 Replace the System Controller 3 Clinically evaluate the patient Refer to page 7 26 LVAD Fault Use the System Monitor to silence the alarm while awaiting resolution if needed Note The alarm must be active in order to access th...

Page 354: ...arm means Either the fixed speed has been set 200 rpm or more below the low speed limit or the System Controller is unable to maintain the speed at or above the low speed limit To resolve alarm Clinicians should 1 Use the System Monitor to check that the fixed speed and low speed limit have been appropriately set 2 Replace the System Controller Refer to page 2 46 3 Clinically evaluate the patient ...

Page 355: ...ans The LVAD has determined that one or more internal LVAD operating conditions are out of range To resolve alarm Patients must call their hospital contact immediately for diagnosis and instructions Clinicians should 1 Contact Thoratec Corporation to determine best next steps 2 Use the System Monitor to silence the alarm while awaiting resolution if needed Alarm silence period The Silence Alarm bu...

Page 356: ...roller Clock Not Set Alarm means The System Controller s internal clock needs to be set Installing a new 11 Volt Lithium Ion backup battery in the System Controller may prompt this alarm To resolve alarm Clinicians should use the System Monitor to set the System Controller s internal clock See Date and Time on page 4 40 Note Be sure the System Monitor clock is correct Alarm silence period The Sile...

Page 357: ...dicator Figure 7 4 and audio tone Different visual and audio indicators are active depending on the alarm condition Refer to Table 7 20 for a description of Power Module alarms and how to respond to them IMPORTANT If an audio alarm sounds from the Power Module without an accompanying visual indicator illuminating at the same time please contact Thoratec Corporation for assistance Refer to page iii...

Page 358: ...p battery is not recharged during AC FAIL 1 Press the Power Module s silence alarm button to silence the alarm it remains silenced indefinitely or until cancelled by another alarm 2 Promptly switch to a new set of charged batteries Advisory LO BATT yellow internal backup battery indicator accompanied by beeping audio tone Less than 15 minutes of Power Module backup battery power remain 1 Press the...

Page 359: ...rs accompanied by continuous audio tone The Power Module backup battery is not functioning properly or is not installed Immediately switch to a new set of charged batteries Table 7 20 Power Module Alarms Continued IMPORTANT The Backup Battery indicator turns yellow and then red as the internal battery is depleted When only 5 minutes of power remain the Power Module audio tone becomes constant and ...

Page 360: ...e on depending on the alarm Figure 7 5 Indicators on the Mobile Power Unit Table 7 21 provides a description of the Mobile Power Unit alarms and how to resolve each alarm Note If there is an alarm for the Mobile Power Unit but no light comes on contact Thoratec Corporation for assistance Refer to page iii for Thoratec Corporation contact information Table 7 21 Mobile Power Unit Alarms Alarm Symbol...

Page 361: ...t 1 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 TO CONFIRM A BATTERY FAULT 1 Remove the battery Examine the battery s metal contact and the contact inside the charging pocket If there is no dirt debris or obstruction continue to Step 2 2 Reinsert the battery into the same pocket 3 If t...

Page 362: ...s Alarm codes related to pocket problems begin with the letter S b Record the alarm code and save it for future reference IMPORTANT Do not use a defective charging pocket until it is repaired or until the Battery Charger is replaced The pockets that are not defective can still be used Detecting Faults with the Entire Charger If the charger detects a fault with the entire charger all four red light...

Page 363: ...ger pocket number X Battery charge cycle count mAh milliamp hour C Battery capacity B0001 Battery fault with alarm code example S0001 Battery Charger pocket slot fault with alarm code example Table 7 22 Battery Charger Display Panel Messages Meaning English Mode Graphics Mode Ready for Use HeartMate CHARGER HeartMate CHARGER Battery Charge Status Y Battery Information 3rd screen X X mAh C X X mAh ...

Page 364: ...ors where the connector and cable meet When the connectors engage push them together firmly until fully connected without twisting or forcing the connectors Secure the connection between the connectors by turning the connector nut on the connector Figure 7 8 Hand tighten the connector nut Do not use tools Do not twist the connectors when turning the nut When disconnecting connectors turn the conne...

Page 365: ...cable and Mobile Power Unit patient cable for twisting kinking or bending Any of these can cause damage to the wires inside even if external damage is not visible Damage to the Driveline or cables could cause the Left Ventricular Assist Device to stop If the Driveline or cables become twisted kinked or bent carefully unravel and straighten CAUTION Use care and do not twist kink or sharply bend the...

Page 366: ...7 Alarms and Troubleshooting 7 38 HeartMate III Left Ventricular Assist System Instructions for Use CAUTION Use care and do not twist kink or sharply bend the System Controller power cables ...

Page 367: ... for Use 7 39 CAUTION Do not twist kink or sharply bend the Mobile Power Unit patient cable 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 ...

Page 368: ...UTION Use care and do not twist kink or sharply bend the Power Module patient cable WARNING 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 ...

Page 369: ...stem Instructions for Use 8 1 EQUIPMENT STORAGE AND CARE This section provides information on how to store and care for the HeartMate III Left Ventricular Assist System Storage and Transport 8 3 Cleaning and Maintenance 8 4 Product Disposal 8 8 ...

Page 370: ...8 Equipment Storage and Care 8 2 HeartMate III Left Ventricular Assist System Instructions for Use ...

Page 371: ...r Module Patient Cable 5 F to 122 F 15 C to 50 C 10 to 93 375 to 795 500 to 1060 System Monitor 5 F to 104 F 15 C to 40 C 10 to 93 375 to 795 500 to 1060 Mobile Power Unit 13 F to 158 F 25 C to 70 C Up to 93 375 to 795 500 to 1060 HeartMate 14 Volt Lithium Ion Batteries 14 F to 104 F 10 C to 40 C 10 to 93 375 to 795 500 to 1060 HeartMate 14 Volt Battery Clips 5 F to 104 F 15 C to 40 C 10 to 93 375...

Page 372: ...d do not attempt to clean the pins yourself Report the condition to Thoratec Corporation Cleaning and service for the System Controller s power connector pins should be performed only by authorized technicians trained by Thoratec Corporation Periodically inspect the System Controller s audio speakers for dirt or grease If a change in tone or in loudness is noticed during a System Controller self t...

Page 373: ...power associated with reduced pump speed as recorded in the System Controller event log file High pulsatility index PI and or the need for frequent replacement of the System Controller Feelings of pump vibrations Fluid leakage from the external portion of the Driveline Cessation of pumping If the Driveline is suspected of damage contact Thoratec Corporation for assistance Refer to page iii for Tho...

Page 374: ...water or liquid it may fail to operate properly or cause an electrical shock Do not clean the Power Module or Mobile Power Unit while it is being used to power the Left Ventricular Assist System If the Mobile Power Unit is left in storage for a long period of time with the batteries installed the alkaline batteries may corrode If corrosion is observed report the condition to Thoratec Corporation R...

Page 375: ...sories include Shower Bag Consolidated Bag System Controller Neck Strap Belt attachment Holster vest Battery holster Protection Bag Keep the wear and carry accessories clean to help them work properly If an accessory gets dirty wash it by hand using mild detergent a medium bristle brush and cold water Never use a washing machine to wash a wear and carry accessory Hang the accessory to drip dry Alw...

Page 376: ...ose of the Power Module backup battery and 11 Volt Lithium Ion backup battery in compliance with all applicable local state and federal regulations Never incinerate the discarded Power Module backup battery or 11 Volt Lithium Ion backup battery Power Module Dispose of or recycle Power Module and Power Module electronics in compliance with all applicable local state and federal regulations Mobile P...

Page 377: ...II Left Ventricular Assist System Instructions for Use A 1 Summary of Clinical Studies TECHNICAL SPECIFICATIONS This section provides the technical specifications for the HeartMate III Left Ventricular Assist System ...

Page 378: ...A A 2 HeartMate III Left Ventricular Assist System Instructions for Use ...

Page 379: ... 80 cc 4 9 cu in Priming Volume 21 cc 1 3 cu in BLOOD CONTACTING SURFACES Titanium Fused titanium microspheres Sealed Outflow Graft Gelatin impregnated woven polyester Inflow Cannula Integrated titanium with fused titanium microspheres CONSTRUCTION Outer Shell Titanium Apical Cannula 20 5 mm 0 8 in titanium Apical Cuff PTFE Felt with integrated locking ring Sealed Outflow Graft Gelatin impregnated...

Page 380: ...harging Sleep Mode Internal Clock Maintenance Power Saver Mode During low battery hazard operation MONITORING FUNCTIONS Fault detection and alarms Performance data processing and storage Battery state of charge indicators and alarms LVAD Status Driveline continuity check Backup battery charge status ALARM SOUND PRESSURE LEVEL SPL Hazard Alarms 85 dB 2300 Hz 300 Hz Advisory Alarms 85 dB 2300 Hz 300...

Page 381: ... minutes at 10 Watts pump speed 9 000 rpm flow 10 0 L min Charge Time 3 hours maximum with a minimum voltage of 13 0V DIMENSIONS Length 7 1 cm 2 8 in Width 5 1 cm 2 in Height 1 5 cm 0 6 in WEIGHT 84 6 g 2 98 oz PRODUCT LIFE 10950 cumulative discharge minutes as tracked by the System Controller and reported on the System Monitor or 3 years from the date of manufacture whichever comes first ...

Page 382: ...System Monitor Isolated dual channel analog uplink AC power failure alarm Advisory Hazard LO BATT alarm for internal backup battery Echoes System Controller Audio Alarm System Malfunction Alarm Yellow Wrench ALARM SOUND PRESSURE LEVEL SPL Hazard Alarms 80 dB Advisory Alarms 80 dB POWER REQUIREMENTS 100 240 VAC 50 60 Hz 1 A maximum To isolate the system from the AC wall power pull the power cord fr...

Page 383: ...TH 6 1 m 20 ft PRODUCT LIFE One year from date of first use ACTIVE FUNCTIONS Isolated power to patient during tethered operation MONITORING FUNCTIONS Fault detection and alarms Echoes System Controller Audio Alarm ALARM SOUND PRESSURE LEVEL SPL Hazard Alarms 80 dB Advisory Alarms 80 dB POWER REQUIREMENTS 100 240 VAC 50 60 Hz 2 0 1 0 A maximum To isolate the system from the AC wall power remove the...

Page 384: ...II Left Ventricular Assist System 5 4 lpm Power Gauge 5 LED button activated Charge Time 4 hours maximum using Battery Charger DIMENSIONS Length 160 mm 6 3 in Width 76 mm 3 0 in Height 25 mm 1 0 in WEIGHT 0 50 kg 1 1 lb System accommodates two batteries PRODUCT LIFE 360 cycles as reported when the battery is inserted into a charging pocket of the Battery Charger or 3 years from the date of manufac...

Page 385: ...acklit Color LCD display with touch screen interface RESOLUTION 640 x 480 pixels FUNCTION Clinical Screen Displays speed flow lpm pulsatility index power mode fixed and Fixed Speed setpoint Displays prioritized alerts and advisories Settings Screen Displays system status and prioritized alerts advisories Permits control of Fixed Speed values Low Speed Limit values and pump stop start Alarms Screen...

Page 386: ...he weight of the batteries battery clips and System Controller with a significant safety factor to allow for forces imparted by daily activities COLOR Black SIZE One size fits most PRODUCT LIFE Two years of continuous use TYPE Water resistant Shower Bag for use with HeartMate III Left Ventricular Assist System FUNCTION Protects external system components from moisture during showering PRODUCT COMP...

Page 387: ...for forces imparted by daily activities COLOR Black SIZE One size fits most PRODUCT LIFE Two years of continuous use TYPE Vest FUNCTION Allows patient to wear two HeartMate 14 Volt Lithium Ion batteries close to the body while performing daily activities PRODUCT COMPATIBILITY For use with System Controller Batteries Battery Clips STRENGTH Accommodates the weight of the batteries battery clips and ...

Page 388: ...III System Controller STRENGTH Each accessory accommodates the weight of the System Controller with a significant safety factor to allow for forces imparted by daily activities COLOR Black SIZE One size fits most PRODUCT LIFE At least two years of continuous use TYPE Shoulder Bag FUNCTION Provides a convenient way to carry and transport the backup System Controller and spare batteries PRODUCT COMP...

Page 389: ...nformation for the HeartMate III Left Ventricular Assist System Safety Testing and Classification B 3 Testing and Classification HeartMate III LVAS B 5 Testing and Classification Power Module B 6 Testing and Classification Mobile Power Unit B 12 Testing and Classification Battery Charger B 17 Testing and Classification HeartMate 14 Volt Lithium Ion Batteries B 24 ...

Page 390: ...B B 2 HeartMate III Left Ventricular Assist System Instructions for Use ...

Page 391: ...3 0 IEC 60601 1 11 2015 IEC 60601 1 8 2006 A1 2012 IEC 60601 1 6 2010 A1 2013 IEC 62366 2007 A1 2014 EN 60601 1 2006 A1 2013 ed 3 1 EN 60601 1 2006 Corr 2 2010 ed 3 0 ANSI AAMI ES60601 1 2005 R 2012 and A1 2012 C1 2009 R 2012 A2 2010 R 2012 ed 3 1 ANSI AAMI ES60601 1 2005 R 2012 and C1 2009 R 2012 and A2 2010 R 2012 ed 3 0 CAN CSA C22 2 No 60601 1 14 ed 3 1 CAN CSA C22 2 No 60601 1 08 ed 3 0 CAN C...

Page 392: ...ater and particulate matter System Controller IP24 Protection against ingress of solid foreign objects the size of a finger and from splashing water Power Module IPX0 Non protected against ingress of water System Monitor IPX1 Protection against ingress of vertically dripping water Shower Bag IPX3 Protection against ingress of spraying water 14 V Battery and Clip only when connected to the System C...

Page 393: ...ity However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to other devices the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the equipment Increase the separation between the equipment Connect the equipment into an outlet on a circuit differe...

Page 394: ...PR 11 EN 55011 Group 1 Class A 30 1 000 MHz The HeartMate III LVAS with Power Module is not suitable for use in domestic establishments or those directly connected to the public low voltage power supply mains network that supplies domestic residential buildings The HeartMate III LVAS with Power Module PM and System Monitor uses RF energy only for its internal purposes and thus have low unintention...

Page 395: ...ange applies For many common 10 Watt maximum transmitters in the 80 MHz to 2 7 GHz range the following minimum separation distances to the HeartMate III LVAS with PM are recommended 80 800 MHz 3 8 m 12 7 feet 800 MHz 2 7 GHz 7 3 m 24 3 feet Note At 800 MHz the separation distance for the higher frequency range applies Equipment a examples Garage door remote controls emergency services radios walki...

Page 396: ...tMate III LVAS with Power Module and its parts than 0 2 m 8 inches Equipment a examples TETRA 400 GMRS LTE Bands GSM and CDMA Phones UMTS Bluetooth WLAN Wi Fi and RFID systems Note 1 000 MHz 1 0 GHz Note The recommended minimum separation distance above is a deviation from IEC 60601 1 2 2014 based on the use environment of the HeartMate III LVAS with Power Module Electrical Fast Transient Burst Im...

Page 397: ...e III LVAS with PM is recommended Outside ISM Amateur bands 150 kHz 80 MHz 1 7 m 5 7 feet In ISM Amateur bands 150 kHz 80 MHz 2 8 m 9 2 feet Equipment a examples CB Radios Amateur HAM radios and Diathermy medical devices Note 1 000 kHz 1 0 MHz Note ISM Industrial Scientific and Medical devices as per the International Technical Union a List is not comprehensive Power Frequency Magnetic Field Immun...

Page 398: ...r 300 cycles 5 sec Mains power quality should be that of a typical commercial or hospital environment where the HeartMate III LVAS with PM is used Note UT A C Mains voltage supply either 50 or 60 Hz cycles per sec WARNING The HeartMate III Left Ventricular Assist System should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the HeartMate III Left Ven...

Page 399: ...le for use in industrial areas and hospitals CISPR 11 class A If it is used in a residential environment for which CISPR 11 class B is normally required this equipment might not offer adequate protection to radio frequency communication services The user might need to take mitigation measures such as relocating or re orienting the equipment ...

Page 400: ...ronment Guidance RF Emissions CISPR 11 EN 55011 Group 1 Class B 30 1 000 MHz The HeartMate III LVAS with Mobile Power Unit is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply mains network that supplies domestic residential buildings The HeartMate III LVAS with Mobile Power Unit uses RF energy only for its ...

Page 401: ...range applies For many common 10 Watt maximum transmitters in the 80 MHz to 2 7 GHz range the following minimum separation distances to the HeartMate III LVAS with Mobile Power Unit are recommended 80 800 MHz 3 8 m 12 5 feet 800 MHz 2 7 GHz 7 3 m 24 0 feet Note At 800 MHz the separation distance for the higher frequency range applies Equipment a examples Garage door remote controls emergency servi...

Page 402: ... III LVAS with Mobile Power Unit and its parts than 0 2 m 8 inches Equipment a examples TETRA 400 GMRS LTE Bands GSM and CDMA Phones UMTS Bluetooth WLAN Wi Fi and RFID systems Note 1 000 MHz 1 0 GHz Note The recommended minimum separation distance above is a deviation from IEC 60601 1 2 2014 based on the use environment of the HeartMate III LVAS with Mobile Power Unit a List is not comprehensive E...

Page 403: ...dical devices Note 1 000 kHz 1 0 MHz Note ISM Industrial Scientific and Medical devices as per the International Technical Union a List is not comprehensive Power Frequency Magnetic Field Immunity IEC 61000 4 8 EN 61000 4 8 30 A m 50 or 60 Hz Power Frequency Magnetic Field should be that of a typical commercial or hospital environment where the HeartMate III LVAS with Mobile Power Unit is used Vol...

Page 404: ... should be used no closer than 20 cm 8 inches to any part of the HeartMate III LVAS powered by the Mobile Power Unit including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result To help ensure good electromagnetic performance throughout the usable life of the HeartMate III LVAS be certain to follow the maintenance schedule and procedures as...

Page 405: ...IEC 60601 1 2 2014 These limits are designed to provide reasonable protection against harmful interference in a typical medical installation This equipment is an unintentional radiator of radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity However there is no guarantee that interference will not oc...

Page 406: ...ng General Safety Standards for Battery Charger Table B 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 of water IPX0 ...

Page 407: ...0 1 000 MHz The HeartMate Battery Charger is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply mains network that supplies domestic residential buildings The HeartMate Battery Charger uses RF energy only for its internal purposes and thus has low unintentional RF emissions and is unlikely to cause interferen...

Page 408: ...e applies For many common 10 Watt maximum transmitters in the 80 MHz to 2 7 GHz range the following minimum separation distances to the HeartMate Battery Charger are recommended 80 800 MHz 3 8 m 12 5 feet 800 MHz 2 7 GHz 7 3 m 24 0 feet Note At 800 MHz the separation distance for the higher frequency range applies Equipment a examples Garage door remote controls emergency services radios walkie ta...

Page 409: ... cables antennas etc operating in the frequencies shown here should not be closer to the HeartMate Battery Charger and its parts than 0 3 m 12 inches Equipment a examples TETRA 400 GMRS LTE Bands GSM and CDMA Phones UMTS Bluetooth WLAN Wi Fi and RFID systems Note 1 000 MHz 1 0 GHz a List is not comprehensive Electrical Fast Transient Burst Immunity IEC 61000 4 4 EN 61000 4 4 2 kV for power supply ...

Page 410: ...Hz 1 0 MHz Note ISM Industrial Scientific and Medical devices as per the International Technical Union a List is not comprehensive Power Frequency Magnetic Field Immunity IEC 61000 4 8 EN 61000 4 8 3 A m 50 or 60 Hz Power Frequency Magnetic Field should be that of a typical commercial or hospital environment where the HeartMate Battery Charger is used Voltage Dips Short Interruptions and Voltage V...

Page 411: ...o verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the HeartMate III LVAS These guidelines may not apply in all situations WARNING Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the HeartMate III Bat...

Page 412: ...ries Table B 6 Declaration Concerning General Safety Standards for HeartMate 14 Volt Lithium Ion Batteries Type Degree of Protection Degree of protection against electric shock No Applied Part Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Equipment not suitable for use in the presence of a flammable anesthetic mixture wit...

Page 413: ...Table B 7 Declaration and Guidance for Electromagnetic Disturbances for HeartMate III Powered by 14 V Li Ion Batteries HeartMate III LVAS Powered By the 14V Li Ion Batteries EM Electromagnetic Disturbance type Standards IEC 60601 1 2 2014 Compliance Level Use Environment Guidance RF Emissions CISPR 11 EN 55011 Group 1 Class B radiated only 30 1 000 MHz The HeartMate III LVAS with 14V Li Ion Batter...

Page 414: ...y range applies For many common 10 Watt maximum transmitters in the 80 MHz to 2 7 GHz range the following minimum separation distances to the HeartMate III LVAS with14V Li Ion Batteries are recommended 80 800 MHz 1 9 m 6 2 feet 800 MHz 2 7 GHz 3 8 m 12 feet Note At 800 MHz the separation distance for the higher frequency range applies Equipment a examples Garage door remote controls emergency serv...

Page 415: ...ortable RF Communication Equipment 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 Equipment a examples TETRA 400 GMRS LTE Bands GSM and CDMA Phones UMTS Bluetooth WLAN Wi Fi and RFID systems Note 1 000 MHz 1 0 GHz Note The recommen...

Page 416: ...S with 14V Li Ion Batteries is recommended Outside ISM bands 150 kHz 80 MHz 1 7 m 5 7 feet In ISM Amateur bands 150 kHz 80 MHz 2 8 m 9 2 feet Equipment a examples include CB Radios Amateur HAM radios Diathermy medical devices Note 1 000 kHz 1 0 MHz Note ISM Industrial Scientific and Medical devices as per the International Technical Union a List is not comprehensive Power Frequency Magnetic Field ...

Page 417: ...normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the HeartMate III LVAS These guidelines may not apply in all situations WARNING Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 20 cm 8 inches to any part of the HeartMate III LVAS powered ...

Page 418: ...ipment does cause harmful interference to other devices which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the equipment Increase the separation between the equipment Connect the equipment into an outlet on a circuit different from that to which the other device or devic...

Page 419: ...Mate III Left Ventricular Assist System Instructions for Use C 1 SYMBOLS This section describes the symbols that are used on the HeartMate III Left Ventricular Assist System components accessories or packaging ...

Page 420: ...C C 2 HeartMate III Left Ventricular Assist System Instructions for Use ...

Page 421: ...umber Serial number Batch code Caution US federal law restricts this device to sale by or on the order of a physician European Conformity Authorized representative in the European community Temperature limit Sterilized using irradiation Sterilized using ethylene oxide Consult instructions for use Do not use if package is damaged MR Unsafe Do not subject to magnetic resonance imaging ...

Page 422: ...f protection provided by enclosures Operating Temperature UL Recognized Component Contains Lithium Ion recycle in accordance with local state and federal regulations Separate collection for batteries and accumulators Use by date Keep dry See instructions for use Non ionizing radiation Fragile handle with care This end up SYMBOL DESCRIPTION ...

Page 423: ...ting current UL product safety mark Symbol Description On product symbols Refer to Checking Battery Charge Status on page 3 50 Charge By HeartMate 14 Volt Lithium Ion batteries must be charged at least once by the end of the month marked on the label affixed to battery packaging box and protective bag Product Use by Symbol Description Backup Battery Use by SYMBOL DESCRIPTION ...

Page 424: ...Patient cable connection Power ON OFF When the Power Module is plugged into a wall socket this symbol illuminates green When the Power Module is operating on internal battery power with less than 15 minutes of power left this symbol illuminates yellow Fuse Rating T 2A 250 Direct Current Rechargeable Battery When the Power Module is recharging the internal battery this symbol illuminates yellow Whe...

Page 425: ...ower Unit Symbols Specific System Monitor Symbols Symbol Description On product symbols Refer to Mobile Power Unit User Interface Components on page 3 37 Symbol Description Power OFF Power ON Input System Monitor only For cable connection from Power Module to port on back of System Monitor ...

Page 426: ...C C 8 HeartMate III Left Ventricular Assist System Instructions for Use ...

Page 427: ...ecklists to assist in performing routine maintenance of the HeartMate III Left Ventricular Assist Device Daily Safety Checklist D 3 Weekly Safety Checklist D 5 Monthly Safety Checklist D 6 Six Month Safety Checklist D 8 Yearly Safety Checklist D 10 As Needed Safety Checklist D 11 Clinic Visit Safety Checklist D 12 ...

Page 428: ...D D 2 HeartMate III Left Ventricular Assist System Instructions for Use ...

Page 429: ...ins and sockets for dirt grease or damage 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 Perform a Power Module self test Maintain the Power Module connection to the AC power source If not properly monitored the internal battery drains causing potential damage Manage the Dr...

Page 430: ...nd the Power Module patient cable or the Mobile Power Unit patient cable and the Power Module or the Mobile Power Unit and AC electrical outlet Confirm bedside items are in place Working flashlight with charged batteries Backup System Controller Two charged HeartMate 14 Volt Lithium Ion batteries and two 14 Volt battery clips Inspect the Driveline Cable for signs of damage such as cracking fraying...

Page 431: ...Module patient cable or the Mobile Power Unit patient cable if it shows signs of damage Obtain a replacement from Thoratec Corporation if needed Inspect HeartMate 14 Volt Lithium Ion batteries for damage Check the battery contacts for denting or damage Replace damaged batteries Do not use batteries that appear damaged Inspect the Battery Charger for signs of physical damage such as dents chips or ...

Page 432: ...that have exceeded 360 cycles Clean the metal battery contacts and the interior contacts of battery clips using a cotton swab or lint free cloth that has been moistened not dripping with rubbing alcohol Allow the alcohol to completely air dry before using newly cleaned batteries or clips Do not clean batteries while the batteries are in use Inspect the Power Module patient cable or Mobile Power Un...

Page 433: ...up battery Unplug the Battery Charger and clean the metal contacts inside all four charging pockets with a lint free cloth or swab that has been moistened not dripping with rubbing alcohol 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 ...

Page 434: ...rm necessary care skills Advise your patient to bring his or her Patient Handbook to the clinic visit Review how to identify an emergency Refer to Patient Handbook section 8 What is an Emergency Review emergency contact list Refer to Patient Handbook Emergency Contact List on page v Review replacing the running System Controller with a backup System Controller Refer to Replacing the Current System...

Page 435: ...nt Handbook section 5 Review using the Shower Bag and showering Refer to Using the Shower Bag on page 6 20 or Patient Handbook section 4 Review caring for the Driveline exit site including cleansing dressing and immobilizing the Driveline Refer to Caring for the Driveline Exit Site on page 6 8 or Patient Handbook section 4 if applicable ...

Page 436: ...on and replacement of the Power Module backup battery WARNING Ensure that the Power Module backup battery is reconnected after service or shipping Refer to Installing the Power Module Backup Battery on page 3 9 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 inspecti...

Page 437: ... batteries using a clean dry cloth Do not use liquids such as water or liquid cleaning solvent to clean batteries Keep batteries dry and away from water or liquid Unplug the Battery Charger and clean the exterior surfaces using a clean damp not wet cloth You may use a mild non abrasive cleaner if necessary Do not submerge the charger in water or liquid REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THA...

Page 438: ...ller IFU section 7 or Patient Handbook section 5 Review Power Module and or Mobile Power Unit alarms and troubleshooting IFU section 7 or Patient Handbook section 5 Remind the patient to follow all hazard and advisory alarm instructions for example call the hospital when the controller instructs the patient to do so Review how to identify an emergency Patient Handbook section 8 Review emergency co...

Page 439: ... HeartMate III Left Ventricular Assist System Instructions for Use E 1 GLOSSARY This section provides a glossary of terms for the HeartMate III Left Ventricular Assist System Abbreviations E 2 Terms E 3 ...

Page 440: ...plantable Cardiac Defibrillators ICU Intensive Care Unit IPM Implantable Pacemaker INR International Normalized Ratio IV Intravenous LPM Liters Per Minute LVAD Left Ventricular Assist Device LVAS Left Ventricular Assist System LMW Low Molecular Weight Ml hr Milliliter per hour MRI Magnetic Resonance Imaging O R Operating Room PI Pulsatility Index PTT Partial Thromboplastin time QD Once daily RPM R...

Page 441: ...t System can be powered by a pair of 14 Volt Lithium Ion batteries An 11 Volt Lithium Ion battery inside the System Controller gives at least 15 minutes of backup power to the system if the main source of power is disconnected or fails Battery button A button on the System Controller user interface that shows a small battery symbol Depending on the mode of operation pressing this button either Wor...

Page 442: ...s this button to bring up data on the user interface s display screen such as current function and alarm history Driveline The Driveline connects the Pump to the System Controller which then connects to a power source The Driveline consists of two cables the Pump Cable and the Modular Cable One end of the Pump Cable connects to the pump implanted in the patient s abdomen The other end of that cabl...

Page 443: ...nsive care usually just after Pump implant J K L Left Ventricular Assist Device The implanted device connected to the left ventricle of the heart that sends blood taken from the Inflow Cannula through the Outflow Graft and into the aorta which sends the blood to the rest of the body The motor inside the device is powered through the Driveline Other terms for the device are Pump heart pump or LVAD ...

Page 444: ...Unit The Mobile Power Unit connects to an AC electrical outlet It provides AC electrical power to the Left Ventricular Assist System Patients must always connect to the Power Module or Mobile Power Unit for sleep or when sleep is possible Connecting to the Mobile Power Unit is also appropriate when patients are stationary or relaxing indoors Modular Cable One of the two cables that make up the Dri...

Page 445: ...Power Module is also appropriate when patients are stationary or relaxing indoors Power Module Backup Battery A backup power source inside the Power Module that gives up to 30 minutes of support if power to the Power Module fails or is disconnected The backup battery works only if it is charged and properly connected Power Saver Mode In power saver mode the System Controller slows pump speed to sa...

Page 446: ...ot fix the alarm condition Slide Lock The mechanical feature on the HeartMate III LVAD that affixes the pump to the Apical Cuff Strap Attachment Points Four places on the System Controller where straps can be easily connected Attachment points allow for holding or carrying the System Controller The System Controller can be worn or carried on a belt or strap or inside a pocket System Controller The...

Page 447: ... Wear and carry accessories are used to safely hold or carry the 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 X Y Yellow Diamond Indicator A yellow colored symbol on the System Controller user interface that illuminates when less than 15 mi...

Page 448: ...E E 10 HeartMate III Left Ventricular Assist System Instructions for Use ...

Page 449: ... carry 6 30 admin screen on System Monitor 4 40 advisory alarms 4 27 backup battery fault 7 21 backup battery not installed 7 22 communication fault 7 20 controller fault 7 19 driveline communication fault 7 24 driveline power fault 7 23 low voltage 7 17 power cable disconnected 7 15 System Controller fault 7 18 7 19 table of 7 8 viewing on System Monitor 4 16 air pressure acceptable range for ope...

Page 450: ... displayed on System Monitor 4 43 installing in System Controller 5 52 recycling 8 8 14 Volt Lithium Ion 3 46 alarms 2 30 calibrating 3 75 charging 3 72 environmental requirements 2 7 8 3 inserting in battery clip 3 58 3 60 on battery power gauge 3 50 power gauge on System Controller 2 16 viewing charge status on System Controller 2 29 wear and carry accessories 6 30 when to remove from service 3 ...

Page 451: ...p battery 3 24 charging 11 Volt Lithium Ion battery 2 33 14 Volt Lithium Ion batteries 3 72 backup System Controller 2 44 checklists D 1 chest compressions external 6 10 cleaning 8 6 batteries and battery clips 8 6 Battery Charger 8 7 driveline 8 5 general guidelines 8 4 Mobile Power Unit 3 45 8 6 System Controller 8 4 System Controller power cables 8 5 wear and carry accessories 8 7 clear alarm b...

Page 452: ...orage and transport 8 3 equipment required for discharge 1 13 equipment required for implant 1 12 event history in System Controller 4 34 event log 4 33 saving to data card 4 35 event recorder in System Controller 4 33 events reviewing on System Monitor 4 39 exit site caring for 6 8 creating 5 34 explant procedures 5 55 external chest compressions 6 10 F fixed speed determining optimal 4 19 flow p...

Page 453: ... available on System Controller 4 42 log files sending to Thoratec 4 37 low battery alarms 2 30 low battery power alarm 7 14 low battery screen 7 14 7 17 low flow alarm 7 11 7 14 low flow screen 7 8 7 11 7 14 low voltage advisory alarm vs low voltage hazard alarm 3 54 low voltage alarm 7 17 M magnetic resonance imaging MRI 6 10 measuring blood pressure 6 8 Mobile Power Unit 3 34 alarms 7 32 cleani...

Page 454: ...procedures connecting and initializing the controller 5 19 preparing patient 5 8 preparing the sealed outflow graft 5 15 preparing running and priming the pump 5 22 unpacking equipment 5 10 warnings and cautions 5 7 preparing for sleep 6 29 preparing ventricular apex site 5 36 Protection Bag for backup System Controller 6 62 pulsatility index parameter 1 17 viewing on clinical screen 4 14 pump com...

Page 455: ...tors 2 14 display button 2 17 driveline connecting 2 21 disconnecting 2 23 environmental requirements for operation 2 7 for storage and transport 8 3 event history 4 34 event recorder 4 33 fault alarm 7 18 7 19 installing backup battery in 5 52 language selecting on System Monitor 4 42 operating modes 2 31 power cable connectors 2 24 power cables cleaning 8 5 pump status 2 18 red battery symbol 2 ...

Page 456: ...for storage and transport 8 3 transport environmental requirements for 8 3 Travel Bag 6 63 travel power cord considerations 3 14 troubleshooting alarms 7 3 tunneling adapter connecting 5 12 5 26 disconnecting 5 23 U user interface on System Controller 2 14 V ventricular apex site preparing 5 36 vest holster 6 54 W warnings defined 1 3 wear and carry accessories 6 30 battery holster 6 48 belt attac...

Page 457: ......

Page 458: ...ilaan 11 Box F1 1935 Zaventem Belgium Tel 32 2 774 68 11 24 Hr Tel 32 0 2 200 66 45 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 2018 T...

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