Product Manual

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14. Network Connectivity and Security
The Coag-Sense meter offers the ability to send patient test results to
electronic medical records or laboratory information systems. The Coag-
Sense meter can be connected to a Local Area Network (LAN) via either
a direct Ethernet connection or wirelessly using Wi-Fi. If this meter is
connected to a local area network, the network must be protected against
unauthorized access. It must not be linked directly to any other network or
the Internet. Customers are responsible for the security of their local area
network, especially in protecting it against malicious software and attacks.
This protection might include measures, such as a firewall to separate the
device from uncontrolled networks and intrusion detection that ensure that
the connected network is free of malicious code including intrusion
detection.
If you use commercial middleware or a customized data management
system solution, ensure that sensitive patient identifiable data transmitted
via the POCT1-A interface is protected by appropriate security measures.
Ensure that the instrument is protected against unauthorized physical
access and theft and that the tamper event label has was intact on
delivery.
Do not use shared user or operator accounts on meter and network.
Whether working in a wired or wireless environment, use a strong alpha
and numeric password for user or operator accounts on the meter and
network. Observe your own facility guidelines on password management
where available.