Recent testing undertaken using the Bedfont NOxBOXi INO therapy monitoring system with F Stephan ventilators has shown compatability between the products.
The neonatal ventilator SOPHIE and its VBS/patient valve system have been validated with the NO dosing device NOxBOXi. The medical devices have been tested in combination according to the requirements given in the test report (sophiefov1-data-26-05-2014) that has been agreed with both manufacturers.
The function of the neonatal ventilator SOPHIE or STEPHANIE is not affected by any of the adjustments or modifications to combine both products. All functions of the ventilators were normal and within the specifications.
The function of the NOxBOXi device was not affected by any of the adjustments or modifications to combine both products. All functions of the NOxBOXi were found to be normal and within the specifications and tolerances.
For full details of the report, please go to http://www.bedfont.com/downloads/StephanGMBH-Bedfont%20Validation%20Statement.pdf