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VISUSCOUT 100-GA-GB-031219
8
Intended use
The ZEISS VISUSCOUT 100 is a medical digital camera that is used to take
digital images and video of the fundus of the human eye.
The ZEISS VISUSCOUT 100 is designed to be used in medical
environment.
This device may only be installed, operated, used and maintained
by persons who have been properly trained or who have the
required knowledge and experience to do so (medical professionals
and trained staff). Please also adhere to the national qualification
guidelines applicable in your country.
Image data is intended for medical documentation and
consultation.
This device may only be set up, operated and used for the specified
purpose and according to national regulations, consistent with the
applicable industry standards and occupational safety and accident
prevention regulations.
Side effects/contraindications
Because prolonged intense light exposure can damage the retina, the use of the
device for ocular examination should not be unnecessarily prolonged, and the
brightness setting should not exceed what is needed to provide clear visualization
of the target structures.
The retinal exposure dose for a photochemical hazard is a product of the radiance
and the exposure time. If the value of radiance were reduced in half, twice the
time would be needed to reach the maximum exposure limit.
While no acute optical radiation hazards have been identified for direct or indirect
ophthalmoscopes, it is recommended that the intensity of light directed into the
patient's eye to be limited to the minimum level which is necessary for diagnosis.
Infants and persons with aphakia or diseased eyes will be at greater risk. The risk
may also be increased if the person being examined has had any exposure with
the same instrument or any other ophthalmic instrument using a visible light
source during the previous 24 hours. This will apply particularly if the eye has
been exposed to retinal photography.
The ZEISS VISUSCOUT 100 classified as Group 2 based on standard ISO
15004-2:2007. The daily usage time and maximum allowed number of pulses is
calculated based on optical classification results according to standard ISO
15004-2:2007.
Содержание VISUSCOUT 100
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