Connection Of External Host And / Or Auxiliary Devices Via Interface - h/p/cosmos 150/50 mercury Operating And Service Manual

7.4.7

Connection of external host and / or auxiliary devices via interface

Many optional and host devices (e.g. ECG, spirometry devices, EMG, etc.) which can be connected to the treadmill via
interface are neither made nor supplied by h/p/cosmos.
Only devices and software which are explicitly declared as compatible by the treadmill
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manufacturer and the manufacturer of the host device (e.g. ECG, spirometry devices, EMG,
accessories, software, etc.) are allowed to be connected to the treadmill.
It is not allowed to connect medical devices (for instance ECG systems) to sports running
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machines.
The summary of clinical data and the risk management of h/p/cosmos covers only the medical treadmill ergometer and
the "intersection" of the risks which arise out of the stress test in ergometry in connection with the host devices (e.g.
ECG, spirometry devices, EMG, etc.).
The summary of clinical data and the risk management of h/p/cosmos does NOT cover any parameter and/or vital
functions which are measured and/or detected by host devices (e.g. ECG, spirometry devices, EMG, etc.) connected to
the treadmill.
For this purpose there are clinical evaluations and risk management processes to be established and performed by the
respective manufacturers of these host devices on an individual basis.
Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC
standards, e.g. IEC 950 for data processing equipment and IEC 60601-1 for medical equipment.
Furthermore all configurations shall comply with the valid version of the system standard IEC 60601-1-1, IEC 60601-1-2,
IEC 60601-1-4 and IEC 60601-1-6. Always use IEC 60601-1 approved potential isolation components when linking
medical devices via interface.
Anyone who connects additional equipment to the signal input or signal output of a medical device configures a medical
system, and is therefore responsible that the system complies with the requirements of the valid version of the system
standard IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4 and IEC 60601-1-6.
h/p/cosmos only approves the interface protocol „coscom v3" for medical applications and herewith confirms the (since
March 21, 2010 (MDD / Directive 2007/47/EC)) mandatory conformity of coscom v3 according to the norms EN 62304
(Life Cycle Requirements for Medical Device Software; Medical Device Software Life Cycle Processes) and EN 14971
(risk management for medical devices) as well as the compliance to a very high safety standard.
All other interface protocols (older versions coscom v2, coscom v1, coscomekg.dll, other treadmill manufacturers, etc.)
are not validated by h/p/cosmos according to the norms EN 62304 and EN 14971 and must not be used for medical
applications (e.g. ergometry, stress-tests, cardiorespiratory diagnostics, performance diagnostics, etc.) since March 21,
2010 in connection with h/p/cosmos treadmills or h/p/cosmos OEM treadmills, except where explicitly approved and
confirmed in writing by h/p/cosmos and the respective manufacturer!
We strongly recommend updating to the latest h/p/cosmos coscom v3 interface protocol. The latest coscom.dll and
implementation notes can be found on www.coscom.org. If you have any questions, please contact
service@h-p-cosmos.com
© 2012 h/p/cosmos sports & medical gmbh
file: n:\article\cos14310m5-v1_06hpc-en\20120504_cos14310m5-v1.06hpc-en_manual_h-p-cosmos_running_machine.docx
email@h-p-cosmos.com
safety, installation and commissioning
created 04.05.2012 printed 04.05.2012 page: 88 of 191