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.
Prescribed fall prevention device (e.g. safety arch [cos10170xx] with chest belt [cos14903-xx] and rope [cos10670xx] or fall prevention system for ceiling mount [cos15866xx] or airwalk ap [cos30028] unweighting device) for any application where falling might cause an inacceptable risk such as osteoporosis, high speed or special applications, applications with persons not able to jump off the running surface, such as children, subjects with all kind of disabilities, impairments (visual, hearing, balance, etc.).
A rip-cord device (pull cord/safety lanyard) with magnet clip [cos101699xx] is NOT a fall prevention device and cannot prevent from falling.
Especially point out the necessary clear safety-zone of minimum L: 200 cm x W: 100 cm (at wider running surfaces minimum the width of the running surface) behind the treadmill and the importance of a fall prevention system in case of a fall.
