Bayer HealthCare MEDRAD MRXperion, Operation Manual, Page: 117 / 126

Operation Manual 18 - 107
The resistance from the earth ground connector at the plug end of the AC mains power cord to any exposed metal on the
scan room unit or power supply enclosure shall be less than 0.2 ohms.
18.13 Classifications
Flammable Anesthetics: The system is not suitable for use in the presence of a flammable anesthetic mixture with air,
oxygen, or nitrous oxide.
18.14 MEDRAD® MRXperion MR Injection System Cybersecurity and IT Network Connection
18.14.1 System Cybersecurity Protection
System software cybersecurity controls include:
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Internal data integrity checks
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Remote access requires valid credentials and a user at the workstation to approve a remote connection
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Service access requires valid credentials
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Access to the Operating System is restricted
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Firewall and Anti-Virus
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(Configurable) Masking Protected Health Information (PHI) when sharing with external systems
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Network settings can only be configured by Bayer
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Data Manager website access requires valid credentials
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Certegra database encrypted and access restricted
18.14.2 Certegra® Workstation Cybersecurity
When Informatics is enabled, the Certegra® Workstation hard drive can contain PHI. The security and privacy of this
information must be safeguarded by all individuals interacting with the device. Prior to disposing of the workstation, this
information must be removed from the hard drive inside the system. Contact Bayer or a local authorized dealer for further
information. Refer to the back cover of this manual for contact information.
18.14.3 IT Network Connection
Connecting the system to an IT Network that includes other equipment could result in unidentified risks to patients,
operators, or third parties.
The organization responsible for managing the network should identify, analyze, evaluate, and control risks associated with
connecting the equipment to the IT Network.
Subsequent changes to the IT Network could introduce new risks and require additional analysis. For example:
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Changes in the IT Network configuration
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Connecting additional items to the IT Network
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Disconnecting items from the IT Network
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Updating and upgrading equipment connected to the IT Network