MI-42-0001 Rev. 19 217
TECHNICAL DESCRIPTION: Network/Data Coupling to Other Equipment
9.11 Network/Data Coupling to Other Equipment
9.11.1 Overview
Network and Data
Coupling
AIRO is designed to be connected to other equipment by network and data couplings.
Characteristics The necessary characteristics of the network/data cou
pling for AIRO are Gigabit Ethernet RJ-45.
Hazards The hazardous situations resulting from a failure of the network/data coupling to provide the
specified characteristics are the inability to transfer information or retrieve worklist or patient
information.
Instructions The Responsible Organization is hereby instructed that:
• Connecting AIRO to a network/data coupling 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 network/data coupling could introduce new risks and require
additional analysis.
• Changes to the network/data coupling include:
- Changes in the network/data coupling configuration.
- Connection of additional items to the network/data coupling.
- Disconnecting items from the network/data coupling.
- Updating the equipment connected to the network/data coupling.
- Upgrading the equipment connected to the network/data coupling.
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