Validity of Atmos Air Charged Urodynamic Catheters across 151 Catheters from Baseline to 100mmHG (0 to 143 cmH20)

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Abstract: The purpose was to validate the functionality of Atmos Air-Charged Catheters1 to properly measure pressure when connected to a Urodynamics machine.

Methods: The hypothesis was that Atmos measures accurate pressure within +/- 5%. Using a calibrated pressure gauge to simulate human cavities, 151 catheters were tested on calibrated pressure sensing units calibrated to a T-DOC® Air-Charged™ Urodynamics Catheter2 to re-enforce that Atmos catheters are backwards compatible with existing UDS equipment and software. Serial pressures were applied to Atmos at 10mmHg intervals from 0mmHg to 100mmHg in the calibration chamber and recorded as cmH20 output from the UDS equipment. Statistical analysis was performed.

Results: Scatterplots showed agreement. The Lin’s concordance correlation coefficient indicates extremely high agreement between the two scores (n=41; ρc = .999, 95% confidence limits .999, .999, p=<.001). The Bland Altman Comparison showed the mean difference between known and measured pressure was -0.897 across all time points with a 95% confidence interval of -0.943, -0.851.

Conclusion: Statistical Analysis of Atmos Air-Charged Catheters shows near-perfect concordance as measured on two independent machines. This far exceeded the target of +/- 5%.

1GEMINI and ATMOS are trademarks of Gemini Medical Technologies LLC. All Rights Reserved. Product names, brands and other trademarks featured or referred to within the GEMINI website and marketing documents are the property of their respective trademark owners

2T-DOC® is a registered trademark of Laborie Medical Technologies Corp

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