Real-Time Wear Tester (RWT)

You can’t always find failure modes with standard testing devices but with the ViVitro Real-Time Wear Tester, you have control over the input waveform, increasing confidence in the integrity of your valve, reducing the risk of clinical failure and expediting your development program.

Overview 

The ViVitro Real-Time Wear Tester (RWT) is the ideal choice for testing large prosthetic heart valves and other cardiovascular devices that don’t fit in standard fatigue testers. Able to accommodate up to six heart valves or other devices simultaneously, the ViVitro RWT applies pressure across the devices, measuring that pressure and collecting the data with ViVitro’s trusted HiTest software. Utilizing the powerful and proven ViVitro SuperPump as the core of this system, the ViVitro RWT is customizable for specific valves and valve mounting arrangements (including conduit mounted valve holders). Built to increase the efficacy and efficiency of your testing process, the ViVitro RWT enables millions of cycles of testing in a short period of time, up to 200 beats per minute.

When combined with the HiTest Data Acquisition System, operators are able to monitor pressure and collect data through an intuitive user interface. The HiTest software meets validation, verification and testing in accordance with ISO 13485 quality standards and outputs results that meet FDA and ISO 5840 requirements.

Testing Capabilities:

• Heart Valve Replacements
• Venous Valve Replacements
• Septal Defect Devices
• Cardiac Patches or Strips
• Medical Sutures, Staples or Clips

Features:

  • Capable of testing up to six heart valves/devices, applying pressure evenly across all devices
  • Accommodates large valves and other devices that conventional high speed testers cannot
  • Operator has control over the input waveform with user interface built for ease of use and waveform downloading
  • Data collected with ViVitro’s proven Hi-Test software, minimizing software learning curve
  • Programmable heating system and integrated temperature controller
  • Operation of RWT is highly visible, enabling you to capture photos and videos of testing in progress and facilitating real-time inspection
  • Cartridges easily accessible enabling quick valve change-out, saving time and damage to valves
  • All components readily accessible, facilitating tuning for more advanced use, such as setting up different variables for applying target pressure across the valve
  • Long term stability of the parameters that influence output pressures
  • Materials used in the ViVitro RWT are compatible with typical test solutions/fluids/sterilants
  • Stand alone operation
  • Easy to clean

Specifications:

Dry Weight: 45kg
Dimensions: Tank 1000mm x 380mm, Controller 430mm x 330mm
Tank Volume: 23 litres
Cycle Rate: 2 – 200 beats per minute
Maximum Stroke Volume: 200 ml/stroke at 200 BPM
Power Requirements: Universal Input 85-265VAC, 47-63Hz
Signal: +5V TTL output synchronization signal

The ViVitro RealTime Wear Tester is manufactured in an ISO 13485 facility.

For a more comprehensive understanding of how the ViVitro RealTime Wear Tester (RWT) can expand and enhance your device testing capabilities, please contact us.