safety, installation and commissioning
file: n:\article\cos14310m5-v1_07hpc-en\20130207_cos14310m5-v1.07hpc-en_h-p-cosmos_treadmill_manual.doc
© 2013 h/p/cosmos sports & medical gmbh author: fh [email protected] created 07.02.2013 printed 04.03.2013 page: 101 of 197
7.4.9
Programmable, electrical medical systems (PEMS) / In-house production
In the event that a user connects standard components to support, diagnose or appraise in terms of in-house production
according to § 12 MPG (Medizinproduktegesetz = German Medical Devices Act), he creates a system and therefore has
to perform and verify a simplified conformity validation process. An in-house production exists when the manufacturer
creates a product or system which is used for diagnostics and/or therapy.
The in-house production of medical products is regulated by the 3rd MPG revision law. According to this, § 12 is only
valid for devices and systems which are created and only applied at the operating place. This means neither the
manufacturer nor the user is 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 with the essential requirements, incl. clinical evaluation,
risk management and the requirements of documentation.
Requirements 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 requires the manufacturer to inform the responsible organization, which means the applier (hospital, medical
practice, etc.), about the following risks in the technical description:
N
The connection of a PEMS to a network or data sharing that includes other devices may lead to unknown risks
for patients, users or third parties.
N
The applier (hospital, medical practice, etc.) should determine, analyse, evaluate and control such risks. The
adequate tool is the risk management according to DIN EN 14971.
N
The applier must be informed that the following changes in the network or data sharing may lead to new risks
and therefore require new analyses.
Changes in network or data sharing respectively may include the following procedures:
N
adding new devices to the network or data sharing respectively
N
removing devices from the network or data sharing respectively
N
devices connected to the network or data sharing respectively have to be state of the art
N
improvement of devices connected to the network or data sharing respectively
Important information:
N
In case the manufacturer declares multiple sockets as valid, these must not be located on the floor in order to
prevent soaking by liquids or 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) is to appoint a so-called system integrator,
responsible for taking care of the tasks that result from the norm. For this reason even ME devices are used which were
not primarily designed to work with other devices or ME devices or ME systems. Therefore, the norm requires a systems
integrator, also known as a system administrator, who is responsible for ensuring that all individual ME devices work
satisfactorily in an integrated system.
