Please refer to the SonoSite SII DICOM Conformance Statement (D18493) for details.
1 Connection of equipment to an IT network that includes other systems, could
2 When a setting of the IT network to which this device is connected has been
Caution
User Guide Errata
result in previously unidentified risks to patients, operators or third parties. Before
connecting the equipment to an uncontrolled IT Network, make sure that all
potential risks resulting from such connections, were identified and evaluated, and
suitable countermeasures were put in place. IEC 80001-1:2010 provides guidance
for addressing these risks.
changed, check that the change does not affect this device and take measures if
necessary. Changes to the IT network include:
Changes in network configuration (IP address, router etc.)
Connection of additional items
Disconnection of items
Update of equipment
Upgrade of equipment
Any changes to the IT network could introduce new risks requiring additional
evaluation to be performed as per item 1 above.
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