Heart Valve Production Quality Test System
The PQT-5000 is the first pulsatile flow heart valve functional performance test system designed specifically for the production environment. This highly advanced system integrates key attributes such as rapid valve exchange for high throughput, multiple cameras to document leaflet kinematics and 21 CFR Part 11 software that integrates both hydrodynamic data and video. The heart valve is assessed against a battery of user-defined QA performance metrics, providing a clear pass-fail result for each valve in a rapid, reliable and highly consistent manner.
The PQT-5000 assesses the functional heart valve performance and leaflet kinematics through a range of parameters such as:
- Forward flow pressure drop
- Regurgitant volume
- Effective orifice area (EOA)
- Coaptation center point
- Central jet area
- Leaflet pinwheel
- Leaflet opening/closing dynamics
- Leaflet edge alignment
The PQT-5000 is an integrated test apparatus that includes the atrial and ventricular chambers, a compliance chamber, peripheral resistance and a valve rapid-exchange mechanism driven by BDC Labs PD-1100 Pulsatile Pump. The system interface is achieved through BDC’s Statys® PQT software. Following detailed consultations with each client, BDC customizes each system for the specific requirements.
PQT-5000 Heart Valve Production Quality Tester
- Highly Versatile for evaluation of all Heart Valve Technologies
- Test Article Rapid Exchange Mechanism
- Facilitates high throughput for heart valve evaluation
- Test fluid is maintained within the test system and at temperature
- Test system fully compatible with chemical sterilization
- Integrated 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: up to 50 °C
- Regulatory Compliance: Complies with 21 CFR Part 11, and all applicable European Union directives and standards for safety and EMC. CE Marked.
- 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 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
- Bar Code Scanner: For absolute traceability, the integrated bar code scanner will acquire that test article identification and document it within the software and test report.
- Standard Speed Cameras: The test system can accommodate up to five cameras to visualize all aspects of the heart valve being evaluated: outflow aspect, inflow aspect and up to three side views.
- High Speed Cameras: High speed cameras are available for the system to provide increased temporal resolution when documenting the leaflet kinematics.
- Automated Image Analysis: Automated image analysis algorithms interrogate the capture video to automatically locate the coaptation center point, presence of a central jet with an associated area, and the offset of leaflet edges when in the closed state.
- Ultrasonic Flow Meter: Temporal inline flow can be measured and documented with a tailored, ultrasonic flow meter located just proximal to the heart valve test article.
- Instrument Workstation: This rugged, customizable instrument workstation featuring levelers and all-welded 16 gauge metal tube frame for durability, offers the following options for a tailored configuration:
- Full width handle for easy control when casters are present
- Adjustable, full-width 16 inch deep upper shelf for locating electronics away from possible liquid spills
- Steel 6 inch drawer for small accessories and tools
- A 3-way height-adjustable arm to mount the system flat-screen monitor
- Articulating keyboard with mouse tray
- Fixed, full-depth lower shelf for large accessories and fluid containers
- Lockable casters for a mobile workstation