natus Dantec Keypoint Focus, Инструкции по эксплуатации оборудования

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Dantec Keypoint Focus
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Electromagnetic compatibility
Requirement Description
Environment for
use
The system is intended to be used in Hospitals and Private practice clinic except for near
active HF surgical equipment and RF shielded room of system for magnetic resonance
imaging, where the intensity of electromagnetic disturbances is high.
Essential
performance
The potential sources of unacceptable risk identified to characterize the ESSENTIAL
PERFORMANCE of a functioning the DIAGNOSTIC EQUIPMENT covered in this RMFare:
• Minimum noise on a waveform or artifacts or distortion in an image and any error of a
displayed numerical value which cannot be attributed to a physiological effect and which
may alter the diagnosis
• Free from the display of incorrect safety-related indications
• Free from the production of excessive stimulation output level
• Free from flames/ fire
Temporary disruption of the stimulators and waveform display has been assessed and
determined to not adversely affect the patient. This type of degradation is not considered to
affect essential performance or safety of the systems.
• In consideration of this, immunity to ESD and power interuptions while in operational
mode, it is acceptable as it relates to the safety and essential performance of the systems
that:
a. Communication between the Base Unit, Amplifier and PC can be lost as long as a
fail-safe mode is entered and the user can recover by re-powering the system
and/or restarting the application software.
b. In the case where communication is not disrupted, the waveforms may contain
electrical artifacts which are distinguishable but must recover after test, with no
mode or parameter changes.
It is not considered an unacceptable risk or affect on the ESSENTIAL PERFORMANCE if the
DIAGNOSTIC EQUIPMENT covered in this RMF becomes completely non-functional, due to
it's intended use.
In case of temporary lost or degraded essential performance due to electromagnetic
disturbances the system will be restored automatically or manual intervention is required to
restart. This depends on degree of disturbance.
Warnings
WARNING : Use of this equipment adjacent to or stacked with other equipment should
be avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are operating
normally.
WARNING : Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this equipment could result in increased electromagnitic
emission or decreased electromagnetic immunity of this equipment and result in improper
operation.
WARNING : Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the Keypoint Focus system including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
Note
NOTE : The emission characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which
CISPR 11 class B is normally required) this equipment might not offer adequate protection to
radio-frequency communication services. The user might need to take mitigation measures,
such as relocation or re-orienting the equipment.