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testing outside a traditional soundproof booth. Custom sound-pressure-level meters are included to
monitor the ambient noise.
The device is suitable for open air testing in areas free from excessive noise. It must be kept dry and free
from dust for reliable, safe operation. The device is a highly sensitive and technically complex device that
should be treated with care. We highly recommend that you use the robust, shock-absorbing, carry case
to transport your device. Mark the package as FRAGILE when it is in transit.
Frequent Usage
The KUDUwave is suitable for continuous, regular use. Analysis of all its functions confirms that there is
no risk to either the operator or patient. These functions are detailed within this document and include
measures to minimise any potential risk.
Applied Parts Details
The following parts are defined as “applied parts” in accordance with
BS EN 60601-1:
Ear Inserts: The Left and Right Ear Inserts will be positioned in the outer
ear by the operator. They do not carry any electrical, chemical or
mechanical energy and contain no metallic parts, and facilitate the
delivery of sound energy to the patient’s ears.
Bone Vibrator: The bone vibrator is positioned against the patient’s
forehead by the operator. From this position it can be used to deliver
sound energy to the patient’s cochlea. The KUDUwave uses a certified
bone vibrator from Radioear.
Operator Training Requirements
Basic Requirements
The operator must be a trained healthcare professional (typically an audiologist, hearing aid acoustician,
general practitioner, ENT, nurse or audiometrist) or a practitioner who has been trained in audiometry.
The operator must be able to read and communicate fluently in English and/or the primary language of
the patient.
Training and Certification Requirements
Training is provided free of charge via an online session within the first 30 days of purchase for both
facilitators and operators of the KUDUwave. Additional training resources are available via the
KUDUwave academy
(https://emoyo.net/kuduwave-academy/) as well as a comprehensive helpdesk
available at emoyo.net/category/helpdesk/. The operator will receive a certificate of completion after
successfully completing their training.
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