Person Responsible for Regulatory Compliance (PRRC)
Nadine Schott
EUDAMED ID Economic Operator Manufacturer:
SRN: DE-MF-000006147
Addendum to all h/p/cosmos treadmill manuals.
Interface connections, systems and compatibilities:
h/p/cosmos validates and recommends only the coscom v4 interface protocol. See www.coscom.org
TMX 425, TMX428, TMX428CP, TMX58 or T2100 or other interface emulations:
Warning and Disclaimer!
This interface protocol is not validated by h/p/cosmos and not released for medical applications in compliance with standard EN 62304 and regulatory compliance. The system producer / configurator (economic operator) is responsible and liable for sufficient testing, release, validation, regulatory compliance (also MDR (EU) 2017/745 and risk management) and documentation of these combined devices (h/p/cosmos treadmill and external control device, such as ECG, CPET, stress test device, etc.) in case of utilizing this protocol emulation.
h/p/cosmos rejects all claims and all liability for any issues related to the usage of the this interface protocol.
