BreathPass iOS mobile APP is used as a user interface for the underlying DSA BreathPass™ device. The iOS mobile APP may only be used in countries where the device either has certification from the regional authorities, is registered for use by the national authorities or where such product may be used as a non-certified product. Verify the acceptance status from the manufacturer.
Process after the indicative test results depends on national regulations and guidance from local health organizations. Confirm that the process used after a positive indicative (Red, sad face) result is performed according to national regulations and guidance, and that all the needed actions to meet the requirements are organized by the test supervisor or a doctor. In case the DSA BreathPassTM gives indicative result, patient need to use another test method to confirm the result.
The DSA BreathPass™ device carries CE certification and is legally accepted for use in European Union and other European countries where Medical CE certification is legally sufficient.
The DSA BreathPass™ can be used legally in Hong Kong as Hong Kong has no specific regulation for Medical Devices or certification process.
DSA will update the list of accepted countries / regions periodically.
Application to control external DSA Analyzer. The unit contains a set of carefully selected and configured nanosensors that record Volatile Organic Compounds (VOC) and biomarkers from exhaled breath. This application is used to forward the data to cloud for further analysis.