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 minimize 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. Please see
https://emoyo.tech/pages/kuduwave-training
Additional
training
resources
are
available
via
the
https://get.emoyo.tech/kuduwave-academy-introduction
) as well as a comprehensive helpdesk
available at
https://emoyo.tech/pages/helpdesk
. The operator will receive a certificate of completion
after successfully completing the Kuduwave Proficiency Assessment.
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