20 Annex
84 / 85 Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04)
List of hazard situations that result from the IT-Network being unable
to provide the features that are required to fulfill the purpose of inte-
grating 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 equipment
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