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Function Tester Production Quality Control System

Turnkey Heart Valve Testing System

The ViVitro Function Tester Production Quality Control System provides a simplified system to assess valve performance criteria for production quality control. The Function Tester assesses pressure and flow criteria while recording high speed valve footage via an integrated camera.

Consisting of a digital camera, quick change cartridge, and QCTest software, the Function Tester is an add-on to the ViVitro Pulse Duplicator and is intended for Production / QC applications. The Function Tester quickly captures reliable results for a fraction of the cost of designing an in-house system.

QCTest software is the only turnkey validated function test software system on the market. The software is easy to use and operates through a USB Multifunction Measurement and Control Board, compatible with 64-bit operating systems.

Developed as a quality control tool for QC heart valve function testing, the ViVitro Function Tester measures valve performance in accordance with regulatory requirements.

QCTest software includes security, risk management, simplified user interface, error checking, control steps and standard disposition outputs. Developed by ViVitro the software meets validation requirements outlined in the FDA General Principles of Software Validation; Final Guidance for Industry, document.

Contact us to learn more about the Function Tester Production Quality Control System and how ViVitro engineering staff can help you meet your Quality Control needs.

 

 

QCTest Screen
Screenshot of Test Tab

 

 

 

Features & Applications
  • Captures pressure and flow data including:
    • Transvalvular Pressure
    • Effective Orifice Area
    • Regurgitant Fraction
  • Captures high-speed video
  • Provides Pass/Fail results
  • Administrators can set individual operation parameters for technicians:
    • Operating conditions
    • User defined Pass/Fail performance assessment
    • Defined calibration expiry intervals
  • Test data is tracked by linking result logs to valve model and serial number
  • Quick-change valve holder can be custom-tailored to valve design
  • Customizable Quick-Change valve holder
QCTest Software
  • Step-by-step calibration wizard
  • Error checking verifies calibration and analysis
  • Algorithms automatically analyze data
  • All program activity is logged for security and legacy
  • Reports formatted for production
  • Each operation is verified step-by-step
  • Administrator controls and creates valve disposition criteria, operating acceptance limits, and Tester/Operator access
  • Data is integrated for accuracy, ensuring validated results
  • Meets applicable IEC and ISO software VV&T requirements
  • .Net 3 Platform
  • Configured for 64-bit Windows 7 operating systems
  • Source code created system for completely validated software
  • Certificate of Conformity provided
  • Validation documents are available

Screenshot of Manage Tab

   

Screenshot of Report Tab

 

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