Physical Characteristics and Clinical Evaluation of a New Disposable Fibreoptic Transducer-Tipped Catheter System

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Abstract
A new disposable fibreoptic transducer-tipped catheter manometer system was evaluated to assess its accuracy, stability of accuracy under prolonged simulated intra-arterial conditions, and dynamic characteristics. Maximum errors observed in the measurement of static pressure using a sample of five catheters (with one display unit) were 2 mmHg at 0 mmHg reference pressure, 2 at 20 mmHg, 4 at 40 mmHg, 4 at 100 mmHg and 9 at 200 mmHg. An immersion artifact caused a shift in baseline of up to 2 mmHg. Exposure of the transducer to 24 hours of simulated intra-arterial conditions (pulsatile pressure at 40°C) resulted in errors of up to 7 mmHg for pressures up to 100 mmHg, and 11 mmHg for 200 mmHg, which were largely attributable to a drift in baseline pressure (up 6 mmHg by 24 hours). Consistent overestimation by the system suggested inappropriate gain setting within the display unit which, however, is not user-adjustable. The system exhibited uniform frequency response up to 33 Hz.