safety, installation and commissioning
file: n:\article\cos14310m5-v1_08hpc-en\20150130_cos14310m5-v1.08hpc-en_instructions_for_use_h-p-cosmos_treadmill.doc
© 2015 h/p/cosmos sports & medical gmbh author: fh [email protected] created 30.01.2015 printed 30.01.2015 page: 108 of 216
The system integrator has to perform the following tasks and must have knowledge of:
N
how to use the integrated system
N
the requirements for the performance of the integrated system
N
what the proposed system configuration looks like
N
what restrictions exist regarding the expandability of the system
N
documents relating to the specifications of all ME devices and other devices to be integrated
N
the performance of each ME unit and other devices
N
the information flow within and around the system
Manufacturers are normally not able to take over the task of a system integrator in the hospital because they neither
have the complete information nor the data that were previously listed. The norm limits the liability of a manufacturer to
supplying the required information on their device. Liability cannot be split between different manufacturers. An operator
such as a hospital or medical practice can, of course, hire a manufacturer or service provider to integrate their system.
In this case, the entire system becomes an ME system. It is the hired manufacturer / service provider who takes the
responsibility to create a properly integrated system.
The system integrator should have the expertise and experience to identify dangers and assess the most likely result of
the integration of a system and to ensure that remaining potential risks are identified during the operation of the system.
For the system integrator this means:
N
he has to plan the integration of all ME devices or ME systems and all non-medical devices according to the
manufacturer’s instructions
N
he has to perform the risk management for the integrated system
N
he has to forward any manufacturer’s information that is needed for the safe use of the integrated system to
the applier (hospital or medical practice).
The norm requires manufacturer information to include information and warnings about hazards that can arise from
configuration changes (upgrades, updates). This means that manufacturers must report all information regarding
software updates and upgrades as well as hardware modifications to the designated system integrator.
The operator should ideally create a complete documentation of both network-based systems, including telemedicine
systems, and changes (technological changes, software changes, upgrades, etc.) and update the document
accordingly.
For this job the system integrator has to be familiar with and know how to apply the risk management norm EN 14971.
The following possible sources of risk in a network or data network may occur:
N
data loss
N
inappropriate data exchange
N
data corruption
N
inappropriate time allocation data
N
unexpected data received
N
non-authorized access to data
N
destructive data
Examples of ME equipment and ME systems on the network and data network:
N
modality connectivity via network to PACS and WEB-based electronic image distribution
N
server-based database for long-term ECG devices or stress test systems
N
telemedicine applications
N
Wi-Fi connectivity of patient monitors
N
et. al.
