RDT-7600i Pulsatile Durability System

The RDT-7600i pulsatile durability & radial fatigue test system is the most innovative and versatile instrument to be offered for testing vascular stents, stent grafts and similar endovascular implants in years. Based on BDC Laboratories’ extensive experience in endovascular device evaluation and test equipment, the RDT-7600i was designed as a true “set it and forget it” pulsatile durability and radial fatigue test system meeting ASTM F2477 and ISO 25539 requirements. The pulsatile diametric strain at each station is measured by an optical micrometer mounted on a computer-controlled stage. During operation, the micrometer moves to predetermined location(s) on the test samples to measure and document their strain at a defined test interval. Therefore, the RDT-7600i system eliminates the need for an operator to manually interface with the system, rotate manifolds, and measure the diametric strain of samples throughout a 400 million cycle test.

In another innovative step, the RDT-7600i is the first pulsatile fatigue test system to offer independent test stations with adjustable motor spacing to facilitate tuning of individual sample’s diametric strain response. Each test station’s independence and adjustability facilitates evaluating samples of different diameters and different lengths on the same test system concurrently.

By combining all unique system features into the Statys® RDTi test system software, the true advantage of this instrument is realized. Once the operator sets a test station to its desired conditions the system will automatically measure and document the sample’s pulsatile diametric strain at the prescribed location(s) and interval. If the strain is found to be outside the allowable tolerance, the system will automatically adjust that station to return it to an in-tolerance condition. Through these automated measurements and adjustments, the operation of the RDT-7600i pulsatile durability and fatigue test system is managed fully by the system throughout the entire test.

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Specifications & Benefits

  • Independent test station tuning and control facilitates the evaluation of different diameter and length samples on the same pulsatile durability test system concurrently
  • As a self-contained test system, it requires a smaller footprint than existing equipment, maximizing the usage of valuable laboratory space
  • Test Sample Diameter: 2.5 mm to 50 mm
  • Operating Frequency:  1 Hz to 80 Hz*
  • Sample Configuration: Straight, Bifurcated, ‘U’, Angled/Bend, Aneurismal
  • Number of Samples: 1 to 12 samples
  • Diameter Measurement: Optical micrometer
  • Temperature: Room to 50°C
  • Regulatory Compliance: Complies with all applicable European Union directives and standards for safety and EMC. CE Marked.

*actual test frequency is dependent upon stent size / configuration

Statys RDTi Software

  • Automated measurement and documentation of diametric strain, with automated adjustment station parameters eliminates the need for operator interactions throughout an entire 400 million cycle study
  • Integrated diametric strain characterization algorithms to facilitate a comprehensive understanding of sample response at accelerated frequencies
  • Continual real-time data monitoring & recording of all signals to document an entire study
  • Integrated, real-time outer diameter to inner diameter calculations based on both ASTM F2477 and ISO 25539 relationships for instantaneous strain feedback
  • Real-time alarms and safeguards to product both the system and test samples
  • User-focused software environment to facilitate ease of system operation and monitoring

Accessories

  • Test Station Barbs:
      Based on the desired silicone mock vessel diameter and geometry, specific barb connectors can be provided to ensure the best connection of vessel/sample to the test system.
  • Silicone Mock Vessels:
      BDC Labs offers certified silicone mock vessels in straight, curved, bifurcated or custom, customer defined configurations for mounting stents, stent grafts, transcatheter heart valve frames and other endovascular implants on the RDTL-0200. Our mock vessels can be fabricated and certified to a diametric compliance or wall thickness, and the certification can be performed at various pulse pressures to meet your specific requirements (e.g., 160 mmHg/80 mmHg).