PerformanceProven Testing - Bayer MVS

PerformanceProven Testing

PerformanceProven testing incorporates proprietary techniques that go beyond standard quantitative array analysis, system testing and visual inspection to diagnose and repair your product.

PerformanceProven Diagnostic Testing

With PerformanceProven diagnostic testing, the most important aspects of your product's functionality are evaluated to ensure that your issue is diagnosed correctly the first time.

  • Visual Inspection: a comprehensive hand inspection by an experienced technician.
    • Nine (9) point inspection - standard, 3D/4D transducers
    • Fifteen (15) point inspection - Transesophageal (TEE) transducers
    • Nine (9) point inspection - MR coils
  • Leakage Analysis: measures the integrity of the transducer's outer insulation barrier, and upper and lower limits of capacitive leakage current.
  • TruSource: an industry-leading tool for testing the integrity of transducer elements and displaying element-by-element performance in real-time, which we use exclusively as a part of our PerformanceProven diagnostic testing.
  • Image Testing: reveals the integrity of the ultrasound image produced by the transducer. It is useful for identifying and validating common image quality issues like drop-out, noise and artifacts in the image. Completes the tests consistent with those required to achieve ACR (American College of Radiology) accreditation, including system sensitivity/penetration and image uniformity.
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Additional Testing for Transesophageal (TEE) Transducers:
  • Articulation: measures the degree of the left, right, anterior, and posterior transducer tip deflection.
  • Insertion Tube Flexibility: measures the amount of force required to linearly displace the insertion tube one inch.
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Specialized proprietary testing for MR Coils
  • Complete RF analysis of the receiving and transmitting elements.
  • Dynamic RF analysis is performed to ensure a stable resonant frequency and Quality Factor of each element.
  • Patient safety circuitry including active and passive decoupling networks and cable traps are tested and inspected to ensure patient safety.
  • All DC control lines are tested for proper voltage drops and current draw. Coil ID circuitry is verified for proper identification by the MRI scanner.
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PerformanceProven Repair Validation
  • We validate our repair processes with the same techniques used by manufacturers to clear new devices for sale.1,2 By scientifically measuring the acoustic performance of our repairs and comparing the performance against brand new transducers, PerformanceProven validation ensures that our repaired transducers function like new. We can PROVE it!
  • Hydrophone Testing: each time we develop full repair capabilities for a new transducer model, we use hydrophone testing to validate our repair, which enables the guaranteed repair solution, TotalREPAIR.
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References:
1. FDA Guidance for Manufacturers Seeking Market Clearance Diagnostic Ultrasound Systems Transducers issued September 9, 2008 - Section 1.6 (P. 10) - Acoustic Output.
2. National Electric Manufacturers Association (NEMA) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 3, Copyright 2004, Section 3.1 (P. 17) - Measurement Device Characteristics.