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safety, warnings, precautions, prohibitions
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: 27 of 213
[4.H]
Programmable, electrical medical systems (PEMS)
[4.H1]
In-house production according to § 12 MPG
In case a user creates a connection of standard components, to support or even perform diagnose and appraisal, in
terms of in-house production according to § 12 MPG (German Medical Devices Act) he creates a system and therefore
has to perform and verify a simplified conformity validation process. An in-house production is existent as the
manufacturer creates a product or system, which is used for diagnostics and/or therapy, himself.
The in-house production of medical products is regulated in the 3rd MPG revision law. According to this the § 12 is only
valid for devices and systems, which are created and only applied at the operating place. That means, as well the
manufacturer as the user are not allowed to put these devices and systems into circulation or give them to third parties
on the single European market.
A simplified conformity evaluation process means the user does not need to create a declaration of conformity or to
inform the notified body, but has to demonstrate the compliance to the essential requirements incl. clinical evaluation,
risk management and the demand of documentation.
Demands out of EN 60601-1 3rd edition, chapter 14.13 and annex H as well as chapter 16:
Connection between programmable, electrical, medical systems (PEMS) and other devices via network or data sharing
respectively.
The norm claims the manufacturer to inform the responsible organization, which means the applier (hospital, medical
practice, etc.), about following risks in the technical description:
•
The connection of a PEMS to a network or data sharing respectively, that includes other devices may cause in
unknown risks for patients, users or third parties.
•
The applier (hospital, medical practice, etc.) should determine, analyze, evaluate and control those risks (the
adequate tool is the risk management according to DIN EN 14971).
•
The applier must be informed that the following changes in the network or data sharing respectively, may lead
to new risks and therefore demand new analyses.
Changes in network or data sharing respectively may include following procedures:
•
Adding new devices to the network or data sharing respectively
•
Removing devices from the network or data sharing respectively
•
Devices, connected to the network or data sharing respectively have to meet the state of the art
•
Improvement of devices connected to the network or data sharing respectively
Important information:
•
In case the manufacturer declares multiple sockets as valid, these have not to be located on the floor, to
prevent soaking of liquids and mechanical damage.
h/p/cosmos herewith informs about all above and below mentioned risks, warnings and
obligations.
Responsibility for system integration:
The operator of ME equipment and ME systems (ME=medical-electrical), has to appoint a so-called system integrator,
responsible for taking care of the tasks that result from the norm. This justifies this claim so that even ME devices are
used, which were not primarily designed to work with other devices or ME-devices or ME-systems. Therefore, the norm