•
This class of equipment is allowed in domestic establishments when used under the jurisdiction of a health care pro-
fessional.
•
Unwanted noise may occur if the device is exposed to a strong radio field. Such noise may interfere with the per-
formance of the device. Many types of electrical devices, e.g. mobile telephones, may generate radio fields. We
recommend that the use of such devices in the vicinity of Aurical Otocam 300 be restricted.
•
RF emissions from Aurical Otocam 300 are very low and are not likely to cause any interference in nearby electronic
equipment. However, local devices placed in close vicinity of Aurical Otocam 300 may experience a negative effect or
loss of functionality..
•
It is recommended to install the unit in an environment that minimizes the amount of static electricity. For example,
anti-static carpeting is recommended.
•
We recommend that the device should not be stacked with other equipment or placed in a poorly ventilated space as
this may affect the performance of the device. If it is stacked or placed adjacent to other equipment, make sure that
the operation of the device is not affected.
•
Before use, ensure that live video is provided on the screen.
•
Before each use of Otocam 300, make sure there are no rough surfaces, sharp edges or protrusions.
•
The distal tip may be warm.
•
To prevent cross-infection or re-infection, do not use the device without a speculum mounted on the distal tip.
•
To prevent cross-infection or re-infection, the speculum must be disposed of after single use.
•
Accidental damage and incorrect handling can have a negative effect on the functionality of the device. Contact your
supplier for advice.
•
Aurical Otocam 300 is intended for use by audiologists and other trained health care professionals in visually inspect-
ing the ear canal and tympanic membrane.
•
Do not use the device for uses other than those described in the Intended Use section. For example, do not use the
device for examination of nasal cavities, eyes or larynx.
•
Do not store or operate Aurical Otocam 300 at temperatures and humidity exceeding those stated in Technical Spe-
cifications. Noncompliance can have negative effects on performance and/or cause degradation of device components.
•
Be careful when you insert the speculum in the ear of the patient - there is a risk of damaging the wall of the ear canal
and/or the tympanic membrane. Do not apply excessive force to the outer ear with the speculum.
•
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and to the
competent authority of the country or the EU Member State in which the user and/or patient is established
When you connect other electrical equipment to Aurical Otocam 300, remember that equipment that does not
comply with the same safety standards as Aurical Otocam 300 can lead to a general reduction in the system's
safety level. The equipment must comply with IEC 60950.
When selecting accessories connected to the Aurical Otocam 300, the following points must be considered:
•
Use of connected equipment in a patient environment
•
Proof that connected equipment has been tested in accordance with IEC60601-1 and/or IEC60601-1-1
Keep the unit away from liquids. Do not allow moisture inside the unit. Moisture inside the unit can damage the instru-
ment and it may result in a risk of electrical shock to the user or patient.
Aurical Otocam 300
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7 Aurical Otocam 300 video otoscope standards and safety