running machine - H-P-COSMOS Sports and Medical

[11.E1] Interface additional information:
technical data
All other systems and devices, which are not in the above stated list, must not be connected to h/p/cosmos
treadmills.
For getting the latest updated list of compatible devices and systems in writing please contact
service@h-p-cosmos.com
Only connect and/or use accessories and software and host equipment if it is approved as compatible by all
manufacturers. Non compliance to this clause can lead to serious injury or death and furthermore manufacturer
warranty and liability expires.
Pay attention to further safety regulations and operation instructions in the appendix of this instruction manual. Pay
special attention to all instructions for operation, maintenance and service also in manuals of all accessories
and/or software.
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. Always use IEC
60601-1 approved potential isolation components when linking medical devices via interface. It is not allowed to
connect sports treadmills to medical devices, for instance ECG-systems.
Everybody who connects additional equipment to the signal input port or signal output port or via any other linkage
possibility, 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.
More recent computers will have only an USB interface instead of the RS232 interface. For that case an „USB to
RS232 interface-adapter-cable“ is available at h/p/cosmos under item no. cos12769. To control via USB interface
you need a processor Pentium 1.8 GHz or higher.
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, Trackmaster, Pacer, 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 diagnostic, performance diagnostic, 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!
The support for all older coscom ® files (including coscomekg.dll version 1.00 and coscom.dll version 1.2.9 and also
including coscom v2) ended on 31.12.2010. Please upgrade to the new coscom v3 .NET Objects and coscom v3
.NET Controls.
Please note also, that the older versions of coscom v1 and coscom v2 are not designed and not documented
based on IEC EN 62304:2006 Medical device software - Software life cycle processes. Therefore since March 21,
2010 it is obligatory to upgrade to h/p/cosmos coscom v3 in order to stay compatible with the latest norms, latest
safety standards and Regulatory Affair Issues when connecting to h/p/cosmos medical treadmills.
We strongly recommend to update to the latest h/p/cosmos coscom v3 interface protocol. The latest coscom.dll
and implementation notes can be found on www.coscom.org. In case you have any questions please contact
service@h-p-cosmos.com
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@h-p-cosmos.com created 15.02.2012 printed 15.02.2012 page: 163 of 213 LN