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Regulatory Information
Problem
Dropouts
15-6
Safety Standards & Specifications
Cause
Low signal strength
RF interference
Monitoring Considerations
Patient should be restricted to the designated coverage area. Monitoring
performance will degrade if patients go outside the radius of coverage
of the receiving wireless network.
A patient location strategy is critical to a telemetry system. If a
life-threatening event occurs, the clinician must be able to locate the
patient quickly. The importance of this increases as the coverage area
increases.
Frequency management is the responsibility of the hospital. Philips
Healthcare has no control over the RF environment in the hospital. If
interference exists at the operating frequencies of the telemetry
equipment, telemetry performance will be affected. Careful selection of
frequencies for all wireless devices used within a facility (transceivers,
other wireless medical devices, etc.) is important to prevent interference
between them.
Caution
IEC/ANSI/AAMI 80001-1:2010
Philips recognizes the importance of a safe and effective network that meets
both the business needs of a healthcare facility, IT networking
requirements, and the clinical functionality. Philips supports the IEC
80001-1 standard in regards to working as a partner with a healthcare
organization in the design, implementation, and management of the
Medical IT-Network to properly provision and support not only Philips
devices, but all the devices using the network. Applying the principles of
risk management to hospital frameworks is highly encouraged.
When operating the MX40 on a Customer Supplied Clinical Network,
Philips strongly encourages our customers to perform risk management of
their Medical IT-Network infrastructure in accordance with IEC 80001.
Remedy
See "Signal Strength" below.
See "Radio Frequency Interference"
below.

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