Dräger Atlan A100 Instructions For Use Manual page 17

Anesthesia workstation
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Structure of a network
The use of the data interfaces establishes a network with the connected device
and, if necessary, also with other devices. This may place the data security and
functional reliability at risk. Personal injury and property damage may occur as a
consequence.
► Before activating an interface, the operating organization must assess the data
security and functional security risks.
Connecting this device to a network that incorporates other devices or making
subsequent changes to that network can lead to new risks for patients, users, and
third parties.
Before connecting the device to the network or changing the network, the IT
representatives and the device owner at the health-care facility must ensure the
following:
► The risks must be identified, analyzed, and assessed.
► Appropriate actions must be taken.
Functional impairment of the device
If, in the event of an error, the startup screen shows that the device is not suitable
for clinical use (Not for clinical use), the device may no longer be used.
► Turn off the device. Contact specialized service personnel.
Unauthorized access to the device can impair the device function.
► The operating organization must ensure that external service providers for
Dräger devices adequately protect their service assets (e.g., service software,
installation files) against unauthorized access or manipulation. Protection is
provided, for example, by encrypting hard disks or physically protecting
computers with service software.
► The operating organization must ensure that the remote service running on a
server-based service infrastructure (e.g., SCG) accepts only authenticated
remote desktop connections from other computers.
Security events
Security events may require immediate action or cause messages in the
corresponding logs of the device. These security events may result in risks to
patients, users and third parties.
The following provides examples of possible security events:
– Failed authentication events
– Software installation events
– Configuration events
– Network anomalies
► Inform the health-care facility's IT representatives or the device owner.
► Observe the following information: "Security events", page 307.
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Instructions for use
Atlan A100 (XL), A300 (XL), A350 (XL) SW 2.1n
Safety-related information
17

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