HDTi-6000
Heart Valve Pulse Duplicator Test System
BDC Laboratories’ HDTi-6000 is designed to achieve comprehensive ISO 5840 performance assessments of both transcatheter and surgical heart valves. Configurable as either a left or right heart simulator, the HDTi-600 evaluates valve function at all valve positions, including aortic, mitral, pulmonary, and tricuspid. The HDTi-6000 can be configured with up to 5 high-speed cameras to simultaneously capture multiple views of the test article alongside pressure and flow waveforms. After each test, a variety of waveform and video image analyses characterize valve performance and leaflet kinematics.
The HDTi-6000 is controlled and monitored by our proprietary Statys® HDTi software, featuring pulse duplicator excitation waveform control, seamless integration of high-speed cameras for live and post-test video review, and built-in tools for real-time measurement of pressure drop, effective orifice area, regurgitant volume, and leakage rate.
Key System Features
Seamless Workflow
A novel linear clamp assembly with a captured acrylic fixture streamlines test article exchange without draining system fluid, which improves ease-of-use, throughput, and productivity.
Flow Management
BDC Laboratories’ proven PD-1100 Pulsatile Pump is the fluid driving source for the HDTi-6000 pulse duplicator system, yielding high repeatability, reproducibility, and dynamic configurability.
Synchronized Video
The system synchronizes (optional) high-speed video playback with pressure and flow waveforms, enabling detailed analysis of leaflet response at any point in the cardiac cycle.
Flexibility
Compatible with both standard and custom fixtures to accommodate different sizes and configurations of valves.
Specs and Software
- 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.
- 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 completely assessed and documented from all angles
- Integrated video playback with synchronized pressure and flow waveforms provide the ultimate platform for investigation and analysis
The HDTi-6000 is controlled and monitored by our proprietary Statys® HDTi closed-loop control and monitoring test software, featuring:
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- 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 for the ultimate platform for heart valve leaflet investigation and analysis
- Real-time separation of the continual waveforms into individual beats to ease data review
- Sinusoidal or arbitrary waveform driver excitation to accurately simulate clinical performance
- Cardiac cycle analyzed data can be 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
Extend Your System
Optional accessories are available to extend your system’s capabilities. Add-ons can be purchased to support specific applications and configurations.
Software Accessories
Automated Image Analysis
In addition to manual video measurements, automated image analysis uses advanced software algorithms to identify key attributes quickly and consistently.
Hardware Accessories
High-Speed Camera(s)
Up to five high speed cameras at 1280×1024 resolution for high fidelity when documenting the leaflet kinematics.
Video Calibration Reference
A custom-designed calibration reference aligns all camera aspects to convert pixels to physical dimensions (e.g. millimeters) based on the precise measurement site(s).
Flow Meter with Probe
Customized ultrasonic flow meter with probe provides precise, temporal volume flow measurement.
Adjustable Light Source
An adjustable LED lighting system with either ring or panel lights optimizes video imaging for the system.
Heating Circulation Valve
Valve positioned at the test article to facilitate heating during test system initiation.
System Drip Tray
Drip tray designed to integrated with the test apparatus and capture all fluid leaks.
Equipment Care Program
Proactive Maintenance for Uninterrupted Operations
Why BDC?
A Partner from the Start
From first conversation through final setup, we work closely with your team to deliver the right test systems for your device goals.
Built for Your Timeline
We make it easy to get the equipment you need, when you need it, through expert equipment scoping, timely Factory Acceptance Testing and production, and dependable logistics.
Support That Lasts
We stay involved post-delivery with onboarding, maintenance, and technical support to reduce downtime and help you get the most from your equipment.
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Connect with an Expert at BDC
Provide a few details about your project, and a BDC Laboratories team member will respond within 2 business days to advise on next steps.