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eMoyo KUDUwave - Technical Specifications

eMoyo KUDUwave
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eMKW-TD0054-21- Page 80
Ensure that the patient environment is not too noisy so
non-compliant results are not being recorded.
Confirm that the operator can hear sounds
being presented using the same headset.
The patient cannot hear sounds being
presented even at high intensities.
Inspect the ear probes and eartips for debris
that may be blocking the sounds.
I have run out of ear foam eartips.
Contact your sales representative to obtain new
eartips. Do not continue using the existing ones or
attempt to clean and reuse them.
The KUDUwave 5 software keeps telling me I
have X days until the device needs calibration.
Ensure that you send your KUDUwave to eMoyo to be
calibrated whenever prompted. Contact your local sales
representative for more details.
In Need of Assistance?
Please contact your local IT consultant if you need assistance with confirming your personal computer’s
specifications, or need an upgrade to meet the minimum requirements.
Technical Specifications
WARNING: No modification of this equipment is allowed.
Standards
The KUDUwave has been independently examined, tested and certified by a registered Notified Body in order to ensure
Safety and Design Standards detailed in the General and Audiometry Specifications.
Audiometry Standards
Pure tone: BS EN 60645-1 (Type 3)
Tympanometry BS EN 60645-5 (Type 1)
Other Standards
BS EN 60601-1, BS EN 60601-1-2, BS EN 60601-1-6, BS EN ISO 13485, BS EN
ISO 14971, BS EN 62304, BS EN ISO 14155, BS EN ISO 15223-1, EN 1041
Medical CE mark
European Council Directive 93/42/EEC
Medical device class
IIa
Calibration
Laboratory calibrated in accordance with:
BS EN 60645-1, EN 60645-2, SANS 10154-1 and
SANS 10154-2
Instrument Specifications
Dimensions
210 x 260 x 110 mm
Shipping
410 x 320 x 190 mm