PQT-5000
Heart Valve Production Quality Test System
The PQT-5000 is designed specifically for cleanroom production environments. It assesses heart valves against a variety of user-defined QA performance metrics, providing a clear pass/fail result for each valve in a rapid, reliable, and highly consistent manner. To support high-throughput workflows, the system features rapid valve exchange.
The PQT-5000 can be configured with multiple integrated cameras to document leaflet kinematics and synchronized capture of hydrodynamic waveform data and high-speed video as needed.
QA Performance Metrics:
- Forward flow pressure drop
- Regurgitant volume
- Effective orifice area (EOA)
- Geometric orifice area (GOA)
- Coaptation center
- Central jet area
- Leaflet pinwheel
- Leaflet opening/closing dynamics
- Leaflet edge alignment
The PQT-5000 is controlled by our proprietary Statys® PQT software, which enables real-time video and hydrodynamic data capture, barcode-enabled digital image stamping (optional), and streamlined test result visualization all in this 21 CFR Part 11 compliant software.
Key System Features
Hemodynamic Precision
Includes atrial and ventricular chambers, a compliance chamber, and peripheral resistance.
Thermal Stability
Facilitates quick exchange of test samples while test fluid circulates to maintain temperature; driven by BDC Laboratories’ PD-1100 Pulsatile Pump.
Serviceability
Designed for efficient break-down and cleaning.
Specs and Software
- Highly versatile for evaluation of all heart valve technologies
- Test system fully compatible with chemical sterilization
- Integrated high-speed video with image analysis to document performance (optional)
- Frequency: 30 – 190 bpm
- Stroke Volume: 0 – 300 ml
- Flow rate: 1 – 10 L/min
- Excitation Waveforms: Sine & Modified Sine
- Sample Sizes: Up to 80 mm
- Test Fluid: Saline, Custom
- Operating Temperature: Room to 50 °C
- Regulatory Compliance: 21 CFR Part 11 Compliant, and all applicable European Union directives and standards for safety and EMC. CE Marked; RoHS Compliant.
The PQT-5000 is controlled and monitored by our proprietary Statys® PQT closed-loop control and monitoring test software, featuring:
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- Three levels of test system login: Operator, Engineer or Administrator
- Operator selectable, pre-defined system configurations for a repeatable and controlled test environment
- Integrated test article pass/fail/undetermined selectable flags
- Concurrent real-time display and recording of hydrodynamic and video data
- Recording of multiple cycles of both hydrodynamic and high-speed video data
- Online measurement tools for acquired video images
- Integrated bar code scanner and digital stamping of video images
- Real-time safeguards to protect both the system and test samples
- 21 CFR Part 11 compliant with automatically generated test reports
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
Bar Code Scanner
For absolute traceability, the integrated bar code scanner captures the test article identification and documents it within the software and test report.
Ultrasonic Flow Meter
A customized ultrasonic flow meter, positioned proximal to the heart valve test article, measures and documents temporal inline flow.
Stainless Steel Assembly
The PQT-5000 can be manufactured from stainless steel and other compatible materials to enable autoclaving of the entire test assembly.
High-Speed Camera(s)
Up to five high speed cameras at 1280×1024 resolution for high fidelity when documenting the leaflet kinematics.
System Circulation Valve
Valve positioned at the test article to facilitate heating during test system initiation.
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).
Adjustable Lighting Source
An adjustable LED lighting system with either ring or panel lights optimizes video imaging for the system.
Auto-Refill Pump
A system-controlled pump replenishes fluid lost during valve exchange and maintains a consistent fluid level during operation, increasing operator and system efficiency.
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.
Explore More
RWT | Heart Valve Real-Time Wear System
HDTi | Heart Valve Pulse Duplicator Test System
SFT | Heart Valve Steady Flow System
Statys® GOA | Heart Valve Analysis Software
VDT | Heart Valve Durability System
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.