Detalo Performance is a non-medical blood volume measurement device intended to be used for athletes to evaluate performance. The device is regulated as a non-medical device in accordance with EU Court ruling C-219/11 and we confirm that the equipment meets the regulatory requirements as such.
The Product is CE marked as consumer electronics and complies with Electromagnetic compatibility: DIN EN 60601-1-2 and Electrical Safety test: LVD 2014/35/EU.
The device is designed to use carbon monoxide which is toxic to humans as it binds to haemoglobin and thereby limits O2 transport to organs. While the bolus of CO applied for the measurement can be compared to what is inhaled if smoking ne cigarette, a %HbCO level of over 50% may result in seizure, coma, and fatality. The device also uses oxygen which comes with the risk of fire. The device is re-used across multiple test persons, which come with the risk of viral or bacterial infection (hence the need of using anti-bacterial filters). The customer should be aware of local regulations and safety requirements for supply, storage, use and disposal of CO and O2.
The device has gone through a detailed risk management process in accordance with ISO 14971 and a number of safety features are included: It’s designed to minimise the amount of CO present in the system at any time and the use of a manually operated “push-to-open” button on the CO supply is mandatory . There is a built-in safety controller that monitors valve configuration and the CO delivery mechanism. Each CO dose needs to be manually confirmed on the device every time and only a dose of maximal 150 ml can be applied. In case of a device failure, power-out or similar, all valves automatically shut down. There is a redundancy of valves to minimise risk unwanted release of CO. There is a redundancy of pressure sensors in the CO chamber to ensure precision of CO dose determination.
Software is built in accordance with IEC 62304 and final certification is in progress. There is a cloud based intelligence solution in place to monitor device functionality when appropriately connected to the internet.