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2 Introduction
Instructions for Use
CLARUS 500
2.6 System Overview
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2660021165005 Rev. A 2017-08
2.6.4 Networking Overview
CLARUS 500 can run as a standalone instrument storing patient
and exam data locally, or it can be connected to a network server
or EMR system to share data and worklists in a central location.
WARNING!
Adding peripheral equipment
may result in noncompliance with the safety requirements of IEC
60601-1.
u
You are responsible for ensuring that the system meets the
safety requirements of IEC60601-1.
u
Place any AC-powered, non-medical device peripherals at least
1.5 m away from the device and connect them to a separation
device, or else use an isolation transformer.
WARNING!
Connection to It-Networks including other equipment
could result in previously unidentified risks related to patients, oper-
ators or third parties.
Changes to the IT networks could introduce new risks that require
additional analysis.
Changes to the IT networks include:
u
Changes to network configurations
u
Connections of additional items
u
Disconnection of items
u
Update of equipment
u
Upgrade of equipment
ü
The Responsible Organization should identify, analyze, evaluate
and control these risks.
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