technical data
file: n:\article\cos14310m5-v1_06hpc-en\20120215_cos14310m5-v1.06hpc-en_manual_h-p-cosmos_running_machine.doc
© 2012 h/p/cosmos sports & medical gmbh [email protected] created 15.02.2012 printed 15.02.2012 page: 164 of 213
L
N
Medical running machines (treadmills) are active therapeutic devices and active diagnostic devices of the risk class
IIb.
Modern PC do not have a RS232 interface, but an USB interface. In this case h/p/cosmos offers a “interface
converter USB / RS232”, article number cos12769. For treadmill control via USB interface the processor must be
at least Pentium 1.8 GHz or higher.
If the equipment is used in the field of medicine, all connected devices and host equipment must be linked with
potential equalization cables. First connect the potential equalization cable with the corresponding potential
equalization plug pin (next to the main switch at the front of the h/p/cosmos device), then connect the entire
medical system to the main potential equalization terminal of the medical room and then connect the mains voltage
power plug of the medical system.
When connecting medical devices to a medical system and/or when putting a company sign/logo/mark on a
medical device, you become the manufacturer of this new device/system and you are responsible for CE-marking,
technical documentation, risk management and all obligations based on MDD and the respective local laws and
norms.
----
Article 12 of MDD Directive 93/42/EEC:
Particular procedure for systems and procedure packs
1. By way of derogation from Article 11 this Article shall apply to systems and procedure packs.
2. Any natural or legal person who puts devices bearing the CE marking together within their intended purpose and
within the limits of use specified by their manufacturers, in order to place them on the market as a system or
procedure pack, shall draw up a declaration by which he states that:
(a) he has verified the mutual compatibility of the devices in accordance with the manufacturers' instructions and
has carried out his operations in accordance with these instructions; and
(b) he has packaged the system or procedure pack and supplied relevant information to users incorporating
relevant instructions from the manufacturers; and
(c) the whole activity is subjected to appropriate methods of internal control and inspection.
Where the conditions above are not met, as in cases where the system or procedure pack incorporate devices
which do not bear a CE marking or where the chosen combination of devices is not compatible in view of their
original intended use, the system or procedure pack shall be treated as a device in its own right and as such be
subjected to the relevant procedure pursuant to Article 11.
3. Any natural or legal person who sterilized, for the purpose of placing on the market, systems or procedure packs
referred to in paragraph 2 or other CE-marked medical devices designed by their manufacturers to be sterilized
before use, shall, at his choice, follow one of the procedures referred to in Annex IV, V or VI. The application of the
abovementioned Annexes and the intervention of the notified body are limited to the aspects of the procedure
relating to the obtaining of sterility. The person shall draw up a declaration stating that sterilization has been
carried out in accordance with the manufacturer's instructions.
4. The products referred to in paragraphs 2 and 3 themselves shall not bear an additional CE marking. They shall
be accompanied by the information referred to in point 13 of Annex I which includes, where appropriate, the
information supplied by the manufacturers of the devices which have been put together. The declaration referred
to in paragraphs 2 and 3 above shall be kept at the disposal of competent authorities for a period of five years.
---- end of Article 12 of MDD Directive 93/42/EEC ---
