eMKW-TD0054-21- Page 90
Reflex stimulus artefact level
At stimulus levels greater than these levels there is a possibility of artefactural
change which exceeds 0.03 cm
3
occuring in the measurement display
synchronously with the reflex stimulus in an ipsilateral measurement. Measured
in cavities from 0.5 to 5 cm
3
.
Ipsilateral reflex stimulus [dBHL]
Temporal reflex characteristics
Initial latency: 20 ms ±15 ms
Rise and fall time: 30 ms ±15 ms
Terminal latency: 10 ms ±15 ms
Undershoot and overshoot: <10 %
Pulsed stimulus characteristics
On time: 55 ms
Off time: 60 ms
Electromagnetic Compatibility (EMC)
Medical electrical equipment needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided in this section. Portable and mobile radio
frequency (RF) communications equipment can affect medical electrical equipment. Following the
guidelines in this section will help prevent this.
Warning: The KUDUwave has been tested to the BS EN 60601-1-2:2015 for both immunity
(susceptibility to interference from external sources) and emissions (interference generated by the
KUDUwave). In order to ensure correct operation the following precautions must be adhered to:
The use of components and cables other than those specified or sold by eMoyo may result in increased
emission or decreased immunity of the KUDUwave. The list of cables and components below must be
adhered to in order to ensure compliance.
The KUDUwave should not be used adjacent to or stacked with other equipment. If adjacent or stacked
use is necessary then the KUDUwave™ should be observed to verify normal operation in the
configuration in which it will be used.
List of cables and components that affect compliance
● USB Cable, Type A to mini-B, maximum length 3.0 metres.
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
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