Thoratec HeartMate II LVAS Manual Download Page 1

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HeartMate II

LVAS

Clinical Operation

& Patient Management

Abbreviated and extracted from the HeartMate II

LVAS Operating Manua

6035 Stoneridge Drive
Pleasanton, CA 94588

Tel. (925)847-8600, Fax. (925)847-8574

HeartLine™ (800)456-1477

www.thoratec.com

104185.A

Summary of Contents for HeartMate II LVAS

Page 1: ...atient 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...

Page 2: ......

Page 3: ...g from Batteries to PBU Tethered Operation 30 Changing Batteries 32 Performing a System Controller Self Test 33 Changing the System Controller Battery Module 34 Replacing System Controllers 35 HANDLIN...

Page 4: ...of patients implanted with the HeartMate II LVAS Learning Objectives After completing this program participants should be able to 1 Identify the components of the HeartMate II LVAS their functions an...

Page 5: ...act with water shower spray or wet surfaces the pump may stop or the patient may receive a serious electrical shock Do NOT use the PBU in the presence of flammable anesthetic agents or an explosion co...

Page 6: ...tec corporation Warnings Specific to Patient or System Management System components must never be immersed in water or liquid Showers and washing are permitted when the clinician approves wound site r...

Page 7: ...20 23o C during use their capacity will be reduced At the low end of the temperature range 15o 10o C run time will be reduced by 50 Use of expired or defective batteries may result in reduced operati...

Page 8: ...evice Infection may con tribute to patient morbidity and death The use of automated blood pressure monitoring devices may not yield accurate blood pressure data Manual ausculation to assess blood pres...

Page 9: ...pable of providing flow from 3 to 10 liters per minute lpm The follow ing pump components that come in contact with the blood have a smooth polished titanium surface pump rotor stators and pump chambe...

Page 10: ...dependent upon the contractile state of the ventricle The simulated monitor tracings Figure 3 show the ventricular and aortic pres sures of a patient The blue waveform represents the pressure at the...

Page 11: ...astole at the same pump speed where the blue waveform inlet pressure and red waveform outlet pressure separate shown by the yellow bar When this occurs the differential pressure rises and the pump mus...

Page 12: ...ases over hours or days may signal a deposition of thrombus inside the pump Depending on the speed power values greater than 10 to 20 watts may also indicate the presence of a thrombus Abrupt changes...

Page 13: ...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 Adjustments can...

Page 14: ...power leads one with a black connector and one with a white connector that connect the System Controller to its power source While both leads provide equal power the white lead contains a data link ca...

Page 15: ...audio alarm is silenced the respective alarm sym bol s flash es as a reminder that the alarm condition remains active When the patient is tethered to the PBU the PBU repeats duplicates a System Contr...

Page 16: ...ot with its metal terminal fac ing up When the battery is in place the yellow light will illuminate while the PBU performs a 10 second load test After testing one of three lights will illuminate to in...

Page 17: ...es in the PBU battery charging slots will not lose their charge dur ing AC mains power failure however neither will they continue to charge dur ing this time Pressing the Alarm Reset switch below the...

Page 18: ...9 To minimize deterioration or damage to batteries Do NOT drop or subject batteries to strong physical shock Do NOT leave or store batteries in hot areas or battery life will be shortened Do NOT use...

Page 19: ...setting is at least 8 000 rpm If the fixed speed setting is below 8 000 rpm you must press and hold the Silence Alarm or Test Select button for a count of two in order to restart the pump Ausculate o...

Page 20: ...attery power remains When this condition arises the LVAD automatically defaults to Power Saver Mode gradually decreasing the pump speed to 8 000 rpm If however the previously selected speed is lower t...

Page 21: ...rmation System Monitor The System Monitor Figures 13a and 13b communicates with the System Controller via the PBU to monitor and record pump and system status It is used to adjust system parameters to...

Page 22: ...screens to indicate active communication between the System Controller and the System Monitor Screen features and functions are described below Note All commands require validation by pressing the ap...

Page 23: ...end of the second alarm banner indicating that additional alarms are active Command Buttons that appear during certain conditions The Pump Start button appears when the pump is stopped or disconnected...

Page 24: ...to increase or decrease the low speed limit in 200 rpm increments between 8 000 and 10 000 rpm This is the alarm limit for low speed operation advisory alarm and the speed to which pump speed will dec...

Page 25: ...utton below Command Buttons that appear only during alarm conditions The Silence Alarm button allows users to silence hazard alarms and power cable disconnected advisory alarms for two minutes and oth...

Page 26: ...cy options are 15 seconds 30 seconds and one minute intervals from 1 to 60 minutes The data logger auto matically turns off when the patient is disconnected from the PBU and must be turned back on whe...

Page 27: ...tem Controller does not have a clock and therefore records only time intervals between events When the events log is downloaded to the System Monitor the monitor counts backward from the current date...

Page 28: ...x imum of 120 events can be displayed on the History Screen 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 Sys...

Page 29: ...x as well as pump power and flow data When an alarm is active Figure 21 the highest priority alarm message alternates with the pump power and flow information Hazard alarms appear in upper case letter...

Page 30: ...very 4 Seconds Low Voltage Advisory Less than 15 minutes of battery power remain voltage is too low or the System Controller is not getting enough power from the PBU Immediately replace depleted batte...

Page 31: ...battery clip 4 Unscrew the black System Controller PBU cable connector Figure 23 An alarm will sound one beep per second the green power symbol will flash rapidly and the four green battery fuel gauge...

Page 32: ...onnectors 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 Wait until the power symbol and b...

Page 33: ...econd the green power symbol will flash rapidly and the four green battery fuel gauge lights will flash 6 Connect the white PBU cable connector by aligning the pins pushing the con nectors together sn...

Page 34: ...ll stop flashing Wait until the power symbol and battery fuel gauge lights stop flashing and the alarm stops sounding before continuing with Step 11 11 Press the battery release button to remove the 1...

Page 35: ...ged battery into the battery clip until it clicks into place The alarm will stop and both the green power symbol and battery fuel gauge lights will stop flashing Wait until the power symbol and batter...

Page 36: ...sed the self test Except for the solid green power symbol which remains on 5 If any of the lights do not illuminate or if the audio tone is intermittent beep ing replace the System Controller see Repl...

Page 37: ...a new one 3 Unscrew counterclockwise the current battery module from the bottom of the System Controller and discard it The yellow battery module symbol will continue to illuminate and an audio tone...

Page 38: ...original Controller by pressing the metal release tab on the connector socket The pump will stop and a continuous alarm will sound Note The alarm will continue until power is removed from the origina...

Page 39: ...witch to another Controller 12 After the pump restarts rotate the perc lock on the new replacement Controller in the direction of the locked icon until the perc lock clicks into the fully locked posit...

Page 40: ...below 8 000 rpm firm ly press the Silence Alarm or Test Select button and hold for a count of two to restart the pump If the pump does not restart check all power sources and the percuta neous lead co...

Page 41: ...al chest compressions may result in disruption of the aortic anastomosis or dislodgement of the LVAD inflow tract Clinical judgement should be used when deciding whether or not to perform exter nal ch...

Page 42: ...site status immobilization of percutaneous lead Vital signs peripheral circulation Mental status level of consciousness 12 lead EKG ECHO Potential Risks Adverse Events Hypovolemia Right Heart failure...

Page 43: ...amage to the percutaneous lead depending on the degree may cause the pump to stop The patient must be educated about the importance of keeping his or her perc lead free from damage Following these rec...

Page 44: ...102512 for detailed information about approaches to successful infection control used by experienced LVAD implant centers with low rates of infection Measuring Blood Pressure Automatic blood pressure...

Page 45: ...tMate LVAS patients to shower unless their physician has given permission after inspecting the exit site wound and confirming that suffi cient healing has occurred Never permit HeartMate II patients t...

Page 46: ...til all equipment is transferred into the Shower Kit may reduce pulling on the exit site b Insert the 1st battery into one of the pockets located on either side of the inner pouch Note Insert the batt...

Page 47: ...rty wash it using mild soap and warm water Once the kit has been washed hang it to drip dry Always allow the kit air dry on its own Never heat the Shower Kit to dry it Make sure the Shower Kit is comp...

Page 48: ...te II LVAS Operating Manual HeartMate II LVAS Patient Handbook HeartMate II LVAS Troubleshooting Guide Infection Control Guidelines HeartMate II LVAS Patient Management Guidelines Pocket Guide to Care...

Page 49: ...15 000 rpm b 5 000 and 25 000 rpm c 8 000 and 12 000 rpm d 100 and 1 000 rpm 4 Pulsatility Index PI is a Increases when pump speed is increased b A measure of ventricular contractility c Adjustable on...

Page 50: ...d d A power lead is disconnected 10 The steps that should be taken if the pump has stopped include all except a Check the percutaneous lead connection to the System Controller and the System Controlle...

Page 51: ...Admin Screen b Clinical Screen c History Screen d Save Data Screen 13 The Extended Silence Button will silence a All alarms for 4 hours b Advisory alarms for 4 hours c Hazard alarms and Power Cable Di...

Page 52: ...rming this test 6 Demonstrate changing the System Controller 7 Identify 2 methods to start the pump and how to assess that the pump has been restarted 8 Explain the significance of the System Controll...

Page 53: ...covered topic adequately 3 Rate overall this program 4 Rate the program facilities Speaker Evaluation Excellent Good Fair Poor N A 5 Rate overall quality of speakers 6 Speaker was organized effective...

Page 54: ...NOTES CLINICAL OPERATION AND PATIENT MANAGEMENT 51...

Page 55: ...NOTES CLINICAL OPERATION AND PATIENT MANAGEMENT 52...

Page 56: ...NOTES CLINICAL OPERATION AND PATIENT MANAGEMENT 53...

Page 57: ...NOTES CLINICAL OPERATION AND PATIENT MANAGEMENT 54...

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