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Required information
The medical device can be used by any adult practitioner of any weight, age, height, gender
and nationality.
The user must not be prone to any of the following:
• Visual impairments: any vision problems must be corrected by glasses or lenses.
• Infirmity of the upper limbs which could prevent manual manipulation of a hand-held device.
• Hearing difficulties that could prevent the user hearing audible indicators depending on
medical devices
• Difficulty in memorising or concentrating that could affect the setting of sequences or the
performance of treatment protocols.
2.4.2 Specific user training
No specific training other than initial professional training is required to use this medical
device.
The practitioner is responsible for performing clinical treatments and for dangers that may
arise due to a lack of skill and/or training.
2.4.3 Devices in contact with the user
Camera head and light cable are in contact with the user.
It is recommended that a sterile disposable protective cover be used on the camera regardless
of the chosen sterilisation procedure and throughout the duration of the surgical procedure.
2.5 Recommended patient population
2.5.1 Patient population
This medical device is designed to be used with the following patient populations:
• Children
• Adolescents
• Adults
• Elderly persons
This medical device can be used irrespectively of the patient's details such as weight, age,
height, gender and nationality.
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