Volk VistaView 4
4Technical Description................................................................
4.1 Specifications.........................................................................
4.2 Operating and Storage Environments...........................
4.3 Transportation Environment..............................................
4.4 Expected Service Life.........................................................
4.5 Disposing of the Device......................................................
5Compatibility and Compliance...............................................
5.1 Electromagnetic Compatibility.........................................
5.2 Compliance..............................................................................
6Troubleshooting............................................................................
6.1 Device Errors..........................................................................
6.2 Image Quality.........................................................................
6.3 System Messages..................................................................
7Warranty..........................................................................................
7.1 Warranty Terms......................................................................
8Support and Servicing...............................................................
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Volk VistaView 5
1. Product Description
1.1 General
The Volk VistaView is a mydriatic fundus camera that is intended to
capture and store images of the fundus of the dilated eye. The device
is capable of taking high quality images with large 55° field of view.
The device uses precision optics and on-board electronics coupled
with an integrated smartphone to capture images of the retina,
macula, and optic disc.
The Volk VistaView requires the eye to be dilated and is intended to
be used by trained professionals in professional healthcare
environments only. Note: The Volk VistaView is a prescription device
which is only intended to be used under the supervision of a physician
or licensed practitioner.
It is the responsibility of the health care provider to protect patient
health information and comply with local regulations regarding patient
health information. The images on the Volk VistaView may contain
identifiable patient information, and it is the responsibility of the
health care provider to ensure that data safeguards are implemented
to protect patient health information.
1.2 Important Symbols
DescriptionSymbol
The device has been tested and conforms to the provisions noted
within the 93/42/EEC Medical Device Directive.
Important operating instructions are included in this
Instructions for Use (IFU). Failure to follow these instructions could
place the patient or operator at risk.
Consult this IFU for important cautionary information. The user is
advised of important operating and maintenance instructions.
A part of the device which in normal use comes into physical
contact with the patient.
Mandatory to refer to this IFU.
1.1 General
1.2 Important Symbols
DescriptionSymbol
The device has been tested and conforms to the
provisions noted within the 93/42/EEC Medical Device Directive.
Important operating instructions are included in this
Instructions for Use (IFU). Failure to follow these instructions could
place the patient or operator at risk.
Consult this IFU for important cautionary information. The user is
advised of important operating and maintenance instructions.
A part of the device which in normal use comes into physical contact
with the patient.
Mandatory to refer to this IFU.
Indicates that the item is a medical device.
Indicates the date when the medical device was manufactured.
The Volk VistaView is a mydriatic fundus camera that is intended to
capture and store images of the fundus of the dilated eye. The device
is capable of taking high quality images with large 55° fi eld of view.
The device uses precision optics and on-board electronics coupled
with an integrated smartphone to capture images of the retina,
macula, and optic disc.
The Volk VistaView requires the eye to be dilated and is intended to
be used by trained professionals in professional healthcare
environments only. Note: The Volk VistaView is a prescription device
which is only intended to be used under the supervision of a physician
or licensed practitioner.
It is the responsibility of the health care provider to protect patient
health information and comply with local regulations regarding patient
health information. The images on the Volk VistaView may contain
identifi able patient information, and it is the responsibility of the
health care provider to ensure that data safeguards are implemented
to protect patient health information.
