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Related Manuals for Thoratec HeartMate II LVAS
Summary of Contents for Thoratec HeartMate II LVAS
- Page 1 HeartMate II ® LVAS Clinical Operation & Patient Management ® Abbreviated and extracted from the HeartMate II LVAS Operating Manual © 2008 Thoratec Corporation 6035 Stoneridge Drive Pleasanton, CA 94588 Tel. (925)847-8600, Fax. (925)847-8574 HeartLine™ (800)456-1477 www.thoratec.com 104185.A...
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Page 3: Table Of Contents
· Pulsatility Index (PI).......9 · Sleeping..........43 · Operating Mode........10 · Showering..........44 PERIPHERAL COMPONENTS....11 THORATEC RESOURCES......45 System Controller........11 Thoratec HeartLine™........45 Power Base Unit (PBU).......13 Published Reference Materials....45 Batteries & Battery Clips......15 POST TEST..........46 Emergency Power Pack (EPP)....18 System Monitor...........18 COMPETENCY ASSESSMENT Display Module..........26... -
Page 4: Introduction
Learning Objectives After completing this program, participants should be able to: 1 Identify the components of the HeartMate II LVAS, their functions, and the the- ory of device operation. 2 List two potential complications associated with a HeartMate II LVAS. -
Page 5: System Overview
LVAS support. A growing fetus will dislodge the pump, which may result in device failure or fatal hemorrhage. In addition, anti- coagulation regimens are contraindicated during pregnancy. · Do NOT subject patients implanted with the HeartMate II LVAS to Magnetic... - Page 6 · Disconnecting the HeartMate II LVAS from the System Controller is advised during open heart defibrillation due to the proximity of the paddles to the device. However, the LVAS should NOT be disconnected during external defibril- lation.
- Page 7 General Precautions · Refer to the HeartMate II LVAS Instructions for Use and the HeartMate II LVAS Operating Manual for detailed instructions and information on device implant and system setup, function, and maintenance. These manuals are not intended to replace comprehensive laboratory or educational programs, or to supercede appropriate medical judgment, however.
- Page 8 CLINICAL OPERATION AND PATIENT MANAGEMENT eral guidelines. Do not incinerate. · Avoid unnecessary pulling or moving of the external portion of the percuta- neous lead, especially as the exit site is healing. Pulling on or moving the lead could prolong the healing process or disrupt an already healed exit site. Disruption of the percutaneous lead exit site increases the patient's risk of acquiring a serious infection.
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Page 9: System Components
· Display Module Note: The following is only an overview of major system components. Refer to the HeartMate II LVAS Operating Manual for complete information. HeartMate II LVAD or “Blood Pump” The HeartMate II left ventricular assist device (LVAD) or “blood pump” is a continuous flow rotary LVAD (Figure 2). - Page 10 CLINICAL OPERATION AND PATIENT MANAGEMENT Starling Curve. The amount of flow generated by the pump is determined by the pump speed and by the pressure gradient that exists across the pump.“Pressure gradient” is defined as the difference between the pressure at the pump outlet and pump inlet. For a specified pump speed, flow varies inversely with pressure across the pump.
- Page 11 CLINICAL OPERATION AND PATIENT MANAGEMENT For a given pump speed, in this case 8,000 rpm, the differential pressure defines what the flow through the pump will be at any given moment. In other words, during cardiac systole the blue waveform (LV pressure) rises and is essentially identical to the red waveform (aortic pressure), which results in a decrease in the differential pressure (gradient) and increased pump flow.
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Page 12: Pump Parameters
CLINICAL OPERATION AND PATIENT MANAGEMENT Pump Parameters The system-provided parameters of speed, power, flow, and pulsatility index (PI), in conjunction with echocardiography, serve as the primary indicators of device func- tion. Once baseline values representing a satisfactory level of patient support are established, the degree of change in a parameter usually has more clinical signifi- cance than its absolute value. -
Page 13: Operating Mode
CLINICAL OPERATION AND PATIENT MANAGEMENT Operating Mode The System Controller has a single primary operating mode, called fixed speed mode, which maintains operation at a constant pump speed between 6,000 and 15,000 rpm. The typical range is 8,000 to 10,000 rpms. Pump speed is adjustable in increments of 200 rpm. -
Page 14: Peripheral Components
WARNING ! The System Controller alarm battery module only provides power to the Controller’s audible alarm tones. It does NOT provide power to the Controller or pump. Figure 5 HeartMate II LVAS System Controller with Leads (note black and white connectors) - Page 15 CLINICAL OPERATION AND PATIENT MANAGEMENT Battery Symbol Test Select Battery Fuel Gauge Silence (yellow & red) Button Alarm Button Controller Power Symbol Red Heart Battery Module (green) Symbol (yellow) Figure 6 System Controller Keypad The System Controller keypad (Figure 6) has a Silence Alarm button and a Test Select button, both of which can be used to interact with the system.
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Page 16: Power Base Unit (Pbu)
If it fails again, battery is defective and should be replaced. Do NOT use defective batteries. Note: If battery shows red light in one slot but yellow or green in another slot, consult Thoratec’s Field Service Department. Table 1 Battery Load Test Status... - Page 17 CLINICAL OPERATION AND PATIENT MANAGEMENT The patient should be connected to the PBU when sleeping or anticipating sleep. The PBU also echoes (duplicates) alarms that are generated by the System Controller. Note: The PBU, like any piece of electrically-powered life-sustaining equipment, should remain continually plugged into a properly-grounded (3-prong) AC mains electrical outlet, except during transport or service.
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Page 18: Batteries & Battery Clips
CLINICAL OPERATION AND PATIENT MANAGEMENT Upon receipt of the PBU, the hospital’s biomedical technician or other author- ized and trained personnel must open the PBU and connect its internal battery prior to set up and use. To confirm that the PBU’s internal battery has been installed and properly charged, turn off the PBU power switch or unplug the PBU power cord from the socket and verify that the the AC fail alarm sounds for longer than 10 seconds and that the AC fail LED light is illuminated. - Page 19 CLINICAL OPERATION AND PATIENT MANAGEMENT Figure 10 Battery Clip and Battery Battery Clips Before connecting the batteries to the System Controller, each battery must be inserted into a HeartMate battery clip (Figure 10). : Battery clips have an elec- Note trical connection for attaching the Controller power leads.
- Page 20 CLINICAL OPERATION AND PATIENT MANAGEMENT Battery Fuel Gauge The HeartMate II System Controller has a set of indicator lights, collectively called the Battery Fuel Gauge . The Battery Fuel Gauge provides an approximate measure of available battery power. More lights indicate more battery power; fewer lights indicate less battery power (see Table 2 below).
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Page 21: Emergency Power Pack (Epp)
Note: Both newer and older models of the System Monitor work with either the HeartMate II LVAS or the HeartMate XVE LVAS. To tell if a System Monitor has been upgraded for HeartMate II, reference the HeartMate logo screen. Older models of... - Page 22 CLINICAL OPERATION AND PATIENT MANAGEMENT logo screen; newer models will display “version 6.10” or higher. The System Monitor has six user interface screens that can be accessed by touching the indicated tab: 1) Clinical Screen 4) Save Data Screen 2) Settings Screen 5) History Screen 3) Alarms Screen 6) Admin (i.e., Administration) Screen...
- Page 23 CLINICAL OPERATION AND PATIENT MANAGEMENT The Clinical Screen contains: Parameter Boxes Four boxes at the top of the screen report measured values of the pump flow, pump speed, pulsatility index (abbreviated on screen as “Pulse Index”), and pump power. Operating Mode and Speed Setpoint The operating mode and speed setpoint are displayed below the parameter boxes.
- Page 24 CLINICAL OPERATION AND PATIENT MANAGEMENT The Settings Screen contains: System Status Boxes Various system parameters are displayed in two System Status boxes. Active Alarm Messages The two highest active alarm messages appear as text banners below the oper- ating mode. If more than two alarms are occurring simultaneously, a “+” will appear at the end of the second alarm banner, indicating that additional alarms are active.
- Page 25 CLINICAL OPERATION AND PATIENT MANAGEMENT Alarms Screen The Alarms Screen (Figure 16) shows the status of all hazard and advisory alarms. The Alarms Screen contains: Alarm Messages All alarms are displayed in the Alarms box, with hazards listed in the upper por- tion and advisories listed in the lower portion.
- Page 26 CLINICAL OPERATION AND PATIENT MANAGEMENT Save Data Screen The Save Data Screen (Figure 17) allows users to change the status of and the rate at which events are recorded on the System Monitor data logger and System Controller event recorder. It is also used to save waveforms with motor performance or information stored in the System Controller event recorder to a data card.
- Page 27 CLINICAL OPERATION AND PATIENT MANAGEMENT 2) At a specified record interval: The System Controller can record data at set time intervals. The record interval indicator specifies the frequency with which information is collected. Frequency options are: off, 0.5 hour, and then hourly increments from one to 24 hours.
- Page 28 Admin Screen The Admin (i.e., administration) Screen (Figure 19) allows users to set the date and time on the System Monitor and to modify the System Monitor’s technical parameters. Note: Only designated Thoratec personnel can modify technical parameters. Figure 19...
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Page 29: Display Module
CLINICAL OPERATION AND PATIENT MANAGEMENT Display Module When connected to the PBU, the Display Module (Figure 20) provides an abbreviat- ed, small-scale display of system performance. The Display Module reports data from the System Controller via the PBU. The Display Module displays current pump mode, speed, and pulse index;... -
Page 30: Alarm Conditions
CLINICAL OPERATION AND PATIENT MANAGEMENT Alarm Conditions The HeartMate II System Controller diagnoses and generates advisory and hazard alarms. If the patient is connected to the PBU, alarm messages are displayed on the System Monitor or Display Module. A summary of alarm conditions, and appropri- ate corrective actions are described in Table 3 below. -
Page 31: Routine Operating Procedures
CLINICAL OPERATION AND PATIENT MANAGEMENT Routine Operating Procedures Changing from PBU to Battery-Powered (Untethered) Operation To change from PBU (tethered) power to battery (untethered) operation: 1 Explain procedure to patient. 2 Place two battery clips, two fully charged HeartMate batteries, and the white and black PBU cable connectors within easy reach. - Page 32 CLINICAL OPERATION AND PATIENT MANAGEMENT 5 Put aside the PBU connector then connect the battery clip connector to the black System Controller connection by aligning the pins, pushing the connec- tors together snugly, and then hand tightening the connectors. The alarm will stop and both the green power symbol and battery fuel gauge lights will stop flashing.
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Page 33: Changing From Batteries To Pbu (Tethered) Operation
CLINICAL OPERATION AND PATIENT MANAGEMENT Changing from Batteries to PBU (Tethered Operation) To change from mobile (battery) operation to tethered (PBU) operation: 1 Explain procedure to patient. 2 Insure that the PBU is plugged in and turned on and the PBU cable is attached to the "Patient"... - Page 34 CLINICAL OPERATION AND PATIENT MANAGEMENT PBU Cable Connector System Controller System Controller PBU Cable Cable Connector Power Lead Figure 25 Unscrewing the PBU and System Controller Cables 7 Put aside the 1 battery/battery clip. 8 Unscrew the black connector from the 2 battery clip.
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Page 35: Changing Batteries
CLINICAL OPERATION AND PATIENT MANAGEMENT Changing Batteries To replace depleted batteries with fully-charged batteries: Explain procedure to patient. Remove batteries and battery clips from the patient's holsters or carrying case. Remove a set of fully-charged spare batteries from the patient’s travel case or from the PBU. -
Page 36: Performing A System Controller Self Test
CLINICAL OPERATION AND PATIENT MANAGEMENT Performing a System Controller Self Test A System Controller self test should be performed daily to ensure that the System Controller’s lights and audio tones are working properly. The patient should be con- nected to the PBU for the test. 1 Explain procedure to patient. -
Page 37: Changing The System Controller Battery Module
CLINICAL OPERATION AND PATIENT MANAGEMENT Changing the System Controller Battery Module The HeartMate II System Controller battery module should last approximately one year. It should be replaced when the yellow battery module symbol on the System Controller keypad illuminates accompanied by one beep every four seconds: 1 Obtain a new System Controller battery module. -
Page 38: Replacing System Controllers
CLINICAL OPERATION AND PATIENT MANAGEMENT Replacing System Controllers Note: If using battery power, ensure that the batteries are fully-charged before replac- ing the current System Controller. In addition, before replacing the current Controller, ensure that the replacement Controller has been programmed with settings that are appropriate for this patient. - Page 39 CLINICAL OPERATION AND PATIENT MANAGEMENT Figure 30 Inserting Connector into HeartMate II System Controller Socket 11 If the pump still does not restart, attempt to restore pump function using the System Controller backup system: a Simultaneously press and hold the Test Select and Silence Alarm buttons. The Red Heart Alarm will stop and an Advisory Alarm will occur with a repeating cycle of one beep per second for two seconds, followed by two seconds of silence to indicate that the System Controller is operating on the backup system.
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Page 40: Handling Emergencies
These conditions are signified by a HAZ- ARD ALARM symbol and accompanied by a CONTINUOUS AUDIO TONE. There are no backups for the HeartMate II LVAS. In the event that the LVAD stops operating, all attempts must be made to restore pump function immediately by: - Checking the percutaneous lead connection to the System Controller;... -
Page 41: Cardiac Arrest
CLINICAL OPERATION AND PATIENT MANAGEMENT Cardiac Arrest There may be risks associated with performing external chest compressions in the event of cardiac arrest, due to the location of the outflow graft and the presence of ventricular apical anastomosis. Performing external chest compressions may result in disruption of the aortic anastomosis or dislodgement of the LVAD inflow tract. -
Page 42: Patient Management
CLINICAL OPERATION AND PATIENT MANAGEMENT Patient Management Patient Assessment HeartMate II patient assessment may include, but not be limited to, assessment of the following: · Pump function · Pump speed, flow, motor power, pulse index (PI), mode of operation · Percutaneous lead connection to System Controller and perc lock is in the locked position ·... -
Page 43: Caring For The Exit Site
Immobilize the percutaneous lead with a Thoratec Stabilization Belt or abdominal binder to reduce trauma to the exit site. Trauma to the exit site will disrupt tissue ingrowth and increase the risk of infection (see Controlling Infection below). -
Page 44: Controlling Infection
Adhere to strict blood glucose control. · Initiate nutritional support to correct nutritional deficits. Note: Refer to Thoratec's Infection Control Guidelines (document number 102512) for detailed information about approaches to successful infection control used by experienced LVAD implant centers with low rates of infection. -
Page 45: Showering
Prior to sleeping, inspect all electrical connections and ensure they are secure. Showering Although the external components of the HeartMate II LVAS are moisture-resistant, they are not waterproof and care must be taken to not expose them to water or a wet environment. - Page 46 CLINICAL OPERATION AND PATIENT MANAGEMENT 2 Use the Shower Kit strap to hang the kit over one shoulder so it’s hanging at the patient’s side. 2 Put the strap around the patient’s neck and hang the kit in front of him or her.
- Page 47 CLINICAL OPERATION AND PATIENT MANAGEMENT 6 Perform exit site care and reapply the stabilization belt to immobilize the percutaneous lead. Caring for the Shower Kit Keeping the Shower Kit clean helps it work properly. If the Shower Kit gets dirty, wash it using mild soap and warm water. Once the kit has been washed, hang it to drip dry.
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Page 48: Thoratec Resources
HeartLine (24-Hour Clinical & Technical Support) Clinicians in the United States may contact Thoratec’s 24-hour HeartLine by dialing: 1-800-456-1477. For emergencies outside the U.S., dial 1-925-847-8600. Note: The HeartLine is not intended for patient use. Patients should contact their care providers. -
Page 49: Post Test
CLINICAL OPERATION AND PATIENT MANAGEMENT Post Test Name______________________________ Date__________ Institution/ Affiliation____________________________________ 1 HeartMate II system components include: a. System Controller b. Power Base Unit (PBU) c. System Monitor d. Emergency Power Pack (EPP) e. All the above 2 What type of valves are used in the HeartMate II? a. - Page 50 CLINICAL OPERATION AND PATIENT MANAGEMENT on the System 7 The non-flashing, round green light Controller indicates: a. The System Controller is receiving power from both power leads b. The pump is receiving power from the System Controller c. The pump is ON d.
- Page 51 CLINICAL OPERATION AND PATIENT MANAGEMENT 12 The information stored in the System Controller event recorder can be viewed on the System Monitor’s: a. Admin Screen b. Clinical Screen c. History Screen d. Save Data Screen 13 The Extended Silence Button will silence: a.
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Page 52: Competency Assessment Checklist
CLINICAL OPERATION AND PATIENT MANAGEMENT Competency Assessment Checklist Competency Criteria Verification 1. Name the components of the HM II system. 2. Interpret the buttons and symbols on the System Controller. 3. Verbalize typical battery times; estimate time remaining using Battery Fuel Gauge. 4. -
Page 53: Program Evaluation
CLINICAL OPERATION AND PATIENT MANAGEMENT Program Evaluation PROGRAM TITLE: HeartMate II LVAS Clinical Operation & Patient Management Program Date: Presenter: Location: Program Evaluation Excellent Good Fair Poor N/A 1 Program met stated objectives. 2 Content covered topic adequately. 3 Rate overall this program. -
Page 54: Notes
CLINICAL OPERATION AND PATIENT MANAGEMENT NOTES... - Page 55 CLINICAL OPERATION AND PATIENT MANAGEMENT NOTES...
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