1Introduction
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• Physical security access measures - access to the monitor must be limited to authorized users.
It is essential that you consider physical security measures to ensure that unauthorized users
cannot gain access.
• Operational security measures - for example, ensuring that patients are discharged after
monitoring in order to remove their data from the monitor.
• Procedural security measures - for example, assigning only staff with a specific role the right to
use the monitors.
In addition, any security concept must consider the requirements of local country laws and regulations.
Always consider data security aspects of the network topology and configuration when connecting
patient monitors to shared networks. Your medical facility is responsible for the security of the
network, where sensitive patient data from the monitor may be transferred.
Note: Log files generated by the monitors and measurement modules are used for system
troubleshooting and do not contain patient data.
About HIPAA Rules
If applicable, your facility’s security strategy should include the standards set forth in the Health
Insurance Portability and Accountability Act of 1996 (HIPAA), introduced by the United States
Department of Health and Human Services. You should consider both the security and the privacy
rules and the HITECH Act when designing policies and procedures. For more information, please
visit http://www.hhs.gov/ocr/privacy/.
About the EU Directives
If applicable, your facility’s security strategy should include the practices set forth in the Directive on
the protection of individuals with regard to the processing of personal data and on the free movement
of such data (Directive 95/46/EC of the European Parliament and of the Council of
24 October 1995). In addition, your facility should also take into account any additional, more
stringent standards put forward by any individual EU countries; that is, Germany, France, and so on.
For more information, please visit http://eur-lex.europa.eu/en/dossier/dossier_27.htm.
Philips Product Security Policy Statement
Additional security and privacy information can be found on the Philips product security web site at
http://www.healthcare.philips.com/main/support/equipment-performance/product-security/
index.wpd
Manufacturer Disclosure Statement for Medical Device Security –
MDS2
You can view the Manufacturer Disclosure Statements for Medical Device Security (MDS
2
) for
specific devices at http://www.healthcare.philips.com/main/support/equipment-performance/
product-security/index.wpd
Introducing the Monitor
The IntelliVue MX400/MX450, MX500/MX550, and MX600/MX700/MX800 patient monitor
offers a monitoring solution optimized for the high-end surgical, cardiac, medical and neonatal care
environments. Combining patient surveillance and data management, it allows multi-measurement
monitoring by linking separate modules. The MX600 uses the navigation knob as primary input device
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