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1 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications.

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Presentation on theme: "1 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications."— Presentation transcript:

1 1 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. © 2014 HeartWare, Inc. TM00017 Rev03 02/14 Module 3/10 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. HeartWare ® Ventricular Assist System Overview

2 2 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. Objectives Provide an overview of the HeartWare ® Ventricular Assist System Describe the function of all HeartWare ® System components –HVAD ® Pump, Implantables, and Surgical Equipment –Patient Peripherals –Hospital Monitor Describe the data provided through HeartWare System waveforms and log files

3 3 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. HeartWare ® System Small pump attaches directly to heart Thin, flexible driveline cable exits skin A small controller & batteries run the pump

4 4 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. HVAD ® Pump, Implantables, and Surgical Equipment

5 5 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. The HeartWare ® System with HVAD ® Pump Continuous flow, centrifugal pump 50cc / 160g, 50mm outside diameter Provides up to 10 liters of flow Wide-blade impeller is the only moving part Hybrid magnetic / hydrodynamic suspension Wear-less system Dual motors designed to provide power efficiency and redundancy

6 6 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. Polyurethane outer sheath Silicone lumen MP35N Alloy cables Dacron sleeve Strain relief Driveline Components MP35N Alloy Cables (similar to pacemaker wires) Silicone Lumen Polyurethane Outer Sheath Strain Relief at Connectors Woven Polyester Sleeve

7 7 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. HeartWare ® System Components Required for Implant 1.HVAD ® Pump 2.Outflow graft 3.Sewing ring 4.Driveline cap 5.Strain relief 6.Inflow cap 7.Driveline extension cable

8 8 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. HeartWare ® System Components Required for Implant 1.Tunneler handle and rod 2.Sewing ring wrench 3.Driveline cover 4.Apical coring tool 5.Hex driver

9 9 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. Patient Electronics and Accessories

10 10 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. Patient Electronics and Accessories HeartWare ® Controller HeartWare ® Shoulder Pack HeartWare ® Shoulder Pack HeartWare ® Waist Pack HeartWare ® Patient Pack HeartWare ® Patient Pack HeartWare ® Battery Charger and Batteries HeartWare ® Controller AC Adapter HeartWare ® Controller DC Adapter

11 11 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. HeartWare ® Controller Microprocessor based unit that controls and manages VAD operation Internal rechargeable battery used to power an audible “no power” alarm Controller attempts to restart pump in case of a pump stop Controller continuously checks the health of critical components and pump power sources Driveline Connection Data Cable Connection

12 12 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. HeartWare ® Controller Display Scroll Button Alarm Mute Button AC/DC Indicator Battery Indicator 1 Alarm Indicator Battery Indicator 2 Controller Display Power Source 2 Power Source 1

13 13 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. HeartWare ® Controller Controller runs on just 1 power source and utilizes the second as backup, but should be connected to 2 power sources at all times –2 batteries –1 battery & AC or DC adapter System drains power consecutively and switches to full second power source when the “Low Battery” alarm is activated Power Connection

14 14 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. One power source indicator (labeled “1” or “2”) will light up based on which port is providing primary power (e.g. “1” in this case) Two battery indicators: AC/DC symbol turns green when connected to an AC or DC adapter The AC/DC adapter will always be the primary source of power if connected Battery CapacityBattery Indicator %4 GREEN lights 50-74%3 GREEN lights 25-49%2 YELLOW lights <24%1 RED light HeartWare ® Controller: Power Source Indicators Power Source 1 Power Source 2

15 15 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. HeartWare ® Controller Power Sources HeartWare ® Battery HeartWare ® Controller AC Adapter HeartWare ® Controller DC Adapter

16 16 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. HeartWare ® Battery Each battery can provide 4 to 6 hours of support Pressing the Test Button will light the Battery Capacity Display Battery Capacity Battery Capacity Display %4 GREEN lights 50-74%3 GREEN lights 25-49%2 GREEN lights <24%1 GREEN light When one battery is depleted to <25%, the controller will automatically switch to the other battery Test Button Battery Capacity Display

17 17 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. HeartWare ® Battery Charger Charges up to 4 batteries at one time Takes up to 5 hours to fully charge a depleted battery Powered by AC outlet only Batteries not in use should be connected and stored in the charger

18 18 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. Battery Charger Status Indicators Battery Charger “Status” Light What it means YellowBattery being charged; NOT ready for use. Flashing Yellow Battery not charging. Check battery connections. If connections are intact, switch to another battery slot. If problem persists, return battery to HeartWare. RedBattery too cold or too hot; waiting to charge. Flashing RedDefective battery. DO NOT use. Mark battery and return to HeartWare.

19 19 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. Patient Pack (Carry Bag) Patient Pack holds the HeartWare ® Controller and 2 HeartWare ® Batteries

20 20 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. Additional Patient Pack Options Instructions on proper packing, use and care can be found in the Patient Manual HeartWare ® Shoulder Pack HeartWare ® Waist Pack

21 21 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. HeartWare ® Shoulder and Waist Pack Use for Patients with Pacemakers or AICDS HeartWare ® Shoulder Pack and HeartWare ® Waist Pack contain magnetic closures Patients with an ICD or Pacemaker should keep these packs away from their chests Per guidelines from pacemaker and ICD manufacturers, magnets should be kept at least 6 inches (15 centimeters) away from the pacemaker or ICD (please refer to manufacturer guidelines for additional information)

22 22 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. HeartWare ® Shower Bag Allows patients to shower with the HeartWare ® Ventricular Assist System Water resistant (not water proof) – protects the controller and batteries from direct water spray and moisture Instructions on proper packing, use and care can be found in the Patient Manual

23 23 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. Hospital Monitor

24 24 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. HeartWare ® Monitor Touch screen tablet PC AC adapter or internal batteries for patient transportation (approx 2 hr battery life) Displays system performance –VAD flow –Pump speed –Watts –Alarms –Real time & historical pump values Pump adjustments

25 25 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. HeartWare ® Monitor Displayed for 10s, 20s, or 1hr Visible on monitor home screen Data updated 50 times per second Accurate flow estimations Speed and power measured directly from pump

26 26 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. Waveforms and Log Files

27 27 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. Waveforms and Log Files Waveforms –Representation of the relationship between the patient and the pump –Indicative of the stroke work done by the ventricle –Should be correlated to physiological variables and clinical presentation –Use as a tool to understand the patient’s condition by understanding waveform variability Controller log files (along with hemodynamic parameters) provide valuable retrospective review of information

28 28 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. HVAD ® Pump Waveforms: Normal Operation The waveform normally has a positive deflection similar to an arterial waveform tracing Flow waveforms are generated and not measured. Variations are indicative of changing clinical conditions and must be validated by accepted medical standards Log file analysis is based solely on data provided to the monitor from the controller without independent verification. The assessments of log files may be indicative of certain patient conditions.

29 29 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. HeartWare ® Controller Log Files Controller logs capture data every 15 minutes Data is stored on a first in first out (FIFO) basis Log files may be downloaded by connecting the controller to the monitor – send to HeartWare for analysis Data FileEvent FileAlarm File ContentAverage Speed, Power and Estimated Flow Controller & Patient ID Battery Capacity User Input Data VAD Start Controller Power Up, etc. Onset/clear of medium and high priority alarms Capacity31 days of data250 entries200 entries

30 30 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. Log File Analysis Log file analysis offers you peace of mind knowing that HeartWare experts are there to help you work through those tough problems when you need them Sample analysis: Log file analysis helps… …troubleshoot pump problems Is this power normal for this amount of flow?..identify patient retraining opportunities Did patient accidentally disconnect both power sources? …evaluate equipment health How long are batteries lasting? …view longer term pump information Is flow trending up or down? Log file analysis helps… …troubleshoot pump problems Is this power normal for this amount of flow?..identify patient retraining opportunities Did patient accidentally disconnect both power sources? …evaluate equipment health How long are batteries lasting? …view longer term pump information Is flow trending up or down?


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