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Thoratec HeartMate II LVAS, Руководство пользователя

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Introduction

Program Description

This inservice program reviews the theory of operation, function, components,
diagnostic monitoring, and related nursing management for the HeartMate II® Left
Ventricular Assist System (LVAS).

Program Objective

The primary objective of this inservice program is to supplement on-site education-
al programs. It is designed to help prepare clinicians for assuming care 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, and the the-
ory of device operation.

2

List two potential complications associated with a HeartMate II LVAS.

3

Identify the purpose and function of each button and symbol on the HeartMate
II LVAS System Controller.

4

Describe the procedure for changing a HeartMate II System Controller.

5

Describe appropriate interventions in the event of an emergency.

CLINICAL OPERATION AND PATIENT MANAGEMENT

1

Содержание HeartMate II LVAS

Страница 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...

Страница 2: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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

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

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

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