Edwards HemoSphere

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HemoSphere Advanced Monitor 8 Data Export and Connectivity Settings
8.4.2 Patient Physiological Data
The HemoSphere advanced monitor can send monitored and calculated physiological parameters in
outbound messages. Outbound messages can be sent to one or more configured enterprise applications.
Continuously monitored and calculated parameters with the HemoSphere advanced monitor can be sent to
the enterprise application.
8.4.3 Physiological Alarms and Device Faults
The HemoSphere advanced monitor can send physiological alarms and device faults to configure HIS.
Alarms and faults can be sent to one or more configured HIS. Statuses of individual alarms including change
in states are sent out to the enterprise application.
For more information on how to receive access to HIS Connectivity, contact your local Edwards
representative or Edwards Technical Support.
WARNING Do not use the HemoSphere advanced monitor as part of a Distributed Alarm System.
The HemoSphere advanced monitor does not support remote alarm monitoring/
management systems. Data is logged and transmitted for charting purposes only.
8.5 Cyber Security
This chapter outlines ways in which patient data can be transferred to and from the HemoSphere advanced
monitor. It is important to note that any facility using the HemoSphere advanced monitor must take
measures to protect the privacy of a patients personal information in accordance with country specific
regulations, and consistent with the facility’s polices for managing this information. Steps that can be taken
to safeguard this information and the general security of the HemoSphere advanced monitor include:
• Physical Access: Limit use of the HemoSphere advanced monitor to authorized users.
• Active Use: Users of the monitor should take measures to limit patient data storage. Patient data
should be removed from the monitor after a patient is discharged and patient monitoring has ended.
• Network Security: The facility must take measures to ensure the security of any shared network
to which the monitor may be connected to.
• Device Security: Users should only use Edwards approved accessories. In addition, ensure that any
connected device is free of malware.
The use of any HemoSphere advanced monitor interface outside of its intended purpose could pose cyber
security risks. No HemoSphere advanced monitor connections are meant to control the operations of
another device. All available interfaces are shown in HemoSphere Advanced Monitor Connection Ports on page 43
and specifications for these interfaces are listed in table A-4, “HemoSphere advanced monitor technical
specifications,” on page 191.
8.5.1 HIPAA
The Health Insurance Portability and Accountability Act of 1996 (HIPAA), introduced by the U.S.
Department of Health and Human Services, outlines important standards to protect individually identifiable
health information. If applicable, these standards should be followed during monitor use.
Status = Released Printed Date: 2018-01-16 Released Date: 2017-09-14