Qualifying Implantable High Voltage Hybrids

Article

Rutkiewicz P.E., Mark Steven; Vane, Mark Alan   (1991, ASQC)   Cardiac Pacemaker Inc., Saint Paul, MN

Annual Quality Congress, Milwaukee WI    Vol. 45    No. 0
QICID: 9634    May 1991    pp. 132-136
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Article Abstract

This abstract is an edited version of the author's original.

This paper discusses some of the challenges of designing appropriate qualification procedures and testing circuits for these hybrids. During the last decade Cardiac Pacemakers Inc. (CPI) developed a new technology to treat tachyarrhythmias, an uncontrolled fast heart beat. This technology has taken the form of the AICD Automatic Implantable Cardioverter Defibrillator, a battery-operated, hermetically sealed , microcontrolled pulse generator.

Qualification of high voltage hybrids used in an implantable defibrillator is a newly defined process. Military specifications alone do not provide the justification for reliability testing of high voltage components or for low duty cycle component use. Implantable applications require different levels of testing, stressing and reliability more than normal commercial or high reliability military hybrids. Implantable hybrid design requires low leakage currents, small size and high reliability, but with lower priorities for temperature, power dissipation or mechanical shock.Discussions include definitions of the terms and process requirements. The process itself covers the four military group qualification requirements and how they are modified for the implantable application. Group A covers the critical electrical parameters. Group B covers hybrid lot testing which includes various environmental stresses. Group C compares the testing and effectiveness of different high temperature biases, power cycling and functional pulse testing. Group D covers the standard package testing, which closely follows the military specifications. The most significant testing issue is overstressing the hybrids with standard military burn-in and life tests.

Keywords

Biomedical,Health care,Medical devices,Reliability,Testing


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