safety, warnings, precautions, prohibitions
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© 2012 h/p/cosmos sports & medical gmbh [email protected] created 15.02.2012 printed 15.02.2012 page: 30 of 213
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Is the network designed to ensure load? Does the number of planned network nodes suffice or is there
redundancy? Is there a structured network cabling?
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Can use errors occur and if so, which? What training, and capabilities, does the operator need to have to
manage and administer the network properly?
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How do the configuration and patch management of the network and connected PEMS occur? Does regular
servicing change the characteristics and properties of the network or data network such as remote service?
What influence do remote service, patch management, etc. have to the connected PEMS such arrangements,
etc.? Does the system administrator takes care of the authorization or approval of patches on the operating
system level, virus protection, etc., and does he examine the effects on PEMS and network?
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Do the medical data arrive at the right place at the right destination in their complete form? May there be
unforeseen changes, the user acknowledges in time?
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Is there a readily available documentation for all hard- and software components with all updates?
IEC 60601-1 classifies networks and data networks as shown in Figure 11 according to criteria A, B and C to
identify a statement about the consequences and required response times. Reaction time means for connection
of a PEMS to a network or data network, the time lag between the occurrence of a fault in the network or data
network and the occurrence of patient harm. Table 1 contains potential risks based on severity and response time
in case of data loss or alteration of data in a network or data network.
Severity
Reaction time
Network class
Example
Death or serious injury
Second(s)
A
Infusion (closed loop), lack control of operation
robot
Minute(s)
A
Missing alarm transfer of an intensive care network
Hour(s)
A/B
Wrong therapy data on dialysis machine or
ventilator
Medium injury
Second(s)
A
Wrong alarm transfer, lack control of operation
robot
Minute(s)
A/B
Wrong alarm transfer, lack control of operation
robot
Hour(s)
B
Image mutilation, loss of therapy protocol
Light injury
Second(s)
B
Minute(s)
B
Loss of a x-ray image
Hour(s)
B/C
Malfunction of a tele-medic connection
minor Second(s)
C
Minute(s)
C
Hour(s)
C
Breakdown of a tele-medic connection
Table 1: Possible risks by severity and reaction time in case of data loss or disturbances of the network or data
network respectively.
