27 Appendices
Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 105 / 106
List of hazard situations that result from the IT-Network being un-
able to provide the features that are required to fulfill the purpose
of integrating the PEMS into to meet the IT-Network:
Loss of data
unsuitable data exchange
Data corruption
unsuitable temporal data allocation
unexpected data reception
unauthorized access to data
Connection of the PEMS to an IT-Network that includes other equip-
ment could result in previously unidentified risks to patients, operators
or third parties.
The responsible organization should identify, analyze, evaluate and
control these risks.
Subsequent changes to the IT-Network could introduce new risks and
require additional analysis.
Changes to the IT-Network include:
changes in IT-Network configuration
connection of additional items to the IT-Network
disconnecting items from the IT-Network
update of equipment connected to the IT-Network
To Next Page
Loading...
