HDTi-6000 Heart Valve Pulse Duplicator Test System

In a revolutionary fashion, BDC Laboratories’ HDTi-6000 heart valve pulse duplicator achieves ISO 5840 performance assessments in a focused and efficient manner with the added capability of integrated high speed video to facilitate real-time visualization of the heart valve under test. The HDTi-6000 can accommodate up to 5 high speed cameras, all simultaneously documenting multiple test article views concurrent with pressure and flow waveforms. After each heart valve test, a variety of both waveform analyses and video image analyses are available to characterize the heart valve’s performance and leaflet kinematics. Included with the many unique system features is the ability to playback the high-speed video while synchronized to the pressure and flow waveforms to comprehensively assess the heart valve leaflet response at any particular point in the cardiac cycle.

The HDTi-6000 pulse duplicator can accommodate both surgical and transcatheter heart valves while being configured as either as a left heart simulator or right heart simulator to evaluate any valve position (i.e. aortic, mitral, pulmonary, tricuspid). Utilizing a novel linear clamp assembly, with no need to drain the system between samples, the HDTi facilitates exchange of the test article in minutes and significantly increases productivity. BDC’s proven PD-1100 pulsatile pump is the fluid driving source for the HDTi-6000 pulse duplicator system yielding high repeatability, reproducibility and dynamic configurability.

The accompanying Statys® HDTi control and monitoring software gives the user absolute control over the pulse duplicator excitation waveform, while seamlessly integrated all high-speed cameras for both live and post-test video review. The system data collection and analysis tools that are embedded in the software provide instantaneous measurement of the test valve parameters such as pressure drop, effective orifice area, regurgitant volume, and leakage rate.

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Specifications & Benefits

• Integrated High Speed Video (Optional):
  • High resolution, high-speed cameras integrated into the pulse duplicator system eliminate the need for secondary video systems
  • With up to 5 cameras, the heart valve under test can be complete assessed and documented from all angles
  • Integrated video playback with synchronized pressure and flow waveforms provide the ultimate platform for investigation and analysis
• Linear Clamp Operation:
  • A captured acrylic fixture-set secures the heart valve test article in the system to facilitate quick exchange and ease-of use
  • Changing of the heart valve test article can occur without the need to drain the system fluid
• Heart Valve Type: Aortic, Mitral, Pulmonary, Tricuspid
• Heart Valve Size: Up to 90 mm
• Flow Rate: 0-10 L/min
• Driving Waveform: Sinusoidal, Arbitrary
• Frequency: 2-240 bpm
• Test Fluid: Water, Saline, PBS Solution, Blood Analog
• Temperature: Room to 50 °C
• Flow Monitoring: Ultrasonic Flowmeter Technology
• Regulatory Compliance: Complies with ISO 5840, and all applicable European Union directives and standards for safety and EMC. CE Marked; RoHS Compliant.

Statys HDTi Software

• Integrated data collection and analysis tools to determine all required ISO 5840 and FDA test parameters either during testing or through post-processing
• Integrated video playback with synchronized pressure and flow waveforms provide the ultimate platform for heart valve leaflet investigation and analysis
• Real-time separation of the continual waveforms into individual beats ease data review
• Sinusoidal or arbitrary waveform driver excitation accurately simulates clinical performance
• Cardiac cycle analyzed data is summarized and output in excel format for secondary processing
• Auto-generated reports with all relevant performance data for efficient documentation of each test
• All temporal signals can be output and saved in high-fidelity for post-test waveform analysis
• User-focused software environment to facilitate ease of system operation

Accessories

• High Speed Cameras:
  The HDTi-6000 pulse duplicator can accommodate up to 5 high speed cameras with 1280×1024 resolution. The cameras can be oriented for inflow, outflow and each of the 3 leaflet side aspects.
• Automated Image Analyses:
  In addition to manual measurements from acquired video, the automated image analysis package provides means to determine key attributes automatically through software algorithms.
• Flow Meter with Probe:
  Customized ultrasonic flow meter with probe provides precise, temporal volume flow measurement.
• Video Calibration Reference:
  Custom designed calibration reference of all camera aspects to convert pixels to physical dimensions (e.g. millimeters) based on the precise measurement site(s).
• Adjustable Lighting Source:
  Optimal system adjustable LED lighting system that includes either ring or panel lights to optimal video imaging.
• Heating Circulation Valve:
  System synthetic valve to utilize at a test article to facilitate heating during initiation of test system.
• System Drip Tray:
  Test system drip tray designed to integrated with the test apparatus and capture all fluid leaks.