running machine - H-P-COSMOS Sports and Medical

safety, warnings, precautions, prohibitions
Examples of ME equipment and ME systems on the network and data network:
• modality connectivity via network to PACS and WEB-based electronic image distribution
• server-based database for long-term ECG devices or stress-test systems
• telemedicine applications
• Wi-Fi connectivity of patient monitors
• et.al.
Appendix A of DIN EN 14971 includes questions to identify characteristics of a medical device that may have security
implications. The application of this Annex on the causes and risks of networks and data network should at least,
according to DIN EN 60601-1, include the following considerations or risk and potential causes respectively:
• Telemedicine and tele-service with external access to internal network or data network of an operator (hospital
or other)
• Remote service of modalities manufacturers
• compatibility of operating systems
• changes and upgrades of the software (operating system, applications, etc.)
• The impact and consequences of patch management
• Interface management (e.g. intolerance of 10 MB network cards with a 100 MB Ethernet network or other)
• Connections (modification of hardware, network connector)
• protocols such as DICOM, HL7 in the network or data network
• Packet address structure and bandwidth
• Heterogeneous network topology
• Normal network traffic and bandwidth requirements
• peak network load
• security and long-term readability of data carriers
• Security against destructive software, unauthorized software updates or upgrades
• Maximum acceptable response time
• Acceptable error rate of the network or data network
• availability during planned and unplanned maintenance
• inconsistency of interfaces and formats, which can lead to loss of accuracy during the data transfer
• etc.
Annex D of the DIN EN 14971 describes examples of risks and other factors in connection between the ME device and
network or data network:
• What predictable abuse can occur?
• Is the connection to the network or data network carried out in accordance to the intended use or purpose
according to § 3 para 10 of the Medical Devices Act, or is it in contradiction?
• Could a false data flow occur from or to any connected PEMS?
• What shall the medical data transferred through the network or data network achieve or what shall happen to
them? What happens if the network or data network collapses during data transmission?
• Can there be any deviations from specified operating characteristics of each participating PEMS?
• What qualities and operating characteristics does a PEMS have and how and in what form may they be
influenced by the network or data network?
• Does a complete description of the parameters of the network or data network exist, such as network topology,
configuration, parameters, bandwidth (100 MB Ethernet, 1GB Ethernet, etc.), etc.?
• Can an overloading of the network or data connections within the network node occur?
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: 29 of 213