22 Annex
Instruction Manual Myopia Master® (G/68100/EN Rev08)
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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
