Electromagnetic Compatibility (Emc); Maintaining; Emc Acceptance Criteria - natus Dantec Keypoint G4 User's And Service Manual

Electromagnetic Compatibility (EMC)

This chapter provides EMC information for the Dantec Keypoint G4 system.
Requirement
Environment for use
Essential performance
Warnings, Cautions
Note

Maintaining

To maintain basic safety and essential performance with regard to electromagnetic disturbances for the expected service life follow guidance
in system in this Instruction for Use in relation to:
• Attaching other equipment
• Maintenance
• List of accessories
• EMC related warnings and notes

EMC Acceptance Criteria

C1) Compliance for the CC-stimulator:
During immunity test Stimulation might be disturbed or switching to safe mode = 0mA and stopped pulsing. Before and after immunity test
pulse max deviation should be 10%. During ESD test (CC mode) Stimulus Probe, LED goggles will be visually monitored and headphone will be
audio monitored to ensure consistent functionality. The stimulators will continue to function throughout the immunity testing, except when
fail safe condition occurs and the stimulation is stopped.
C2) Compliance for the EP Amplifier:
The amplifier curves can be disturbed during testing but must return to baseline after test completion. Before and after immunity test
Description
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.
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.
Read all Warnings and Cautions
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.
prior to use of the Keypoint G4 system.
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