Volk VistaView User manual

Volk VistaView 1
Instructions for Use
Hand-Held Mydriatic Fundus Camera

Volk VistaView 2
Instructions for Use for VistaView Hand-Held Mydriatic Fundus Camera
Volk VistaView ™
Volk Optical Inc.
7893 Enterprise Drive
Mentor, OH 44060 USA
volk.com
[e-mail]
Toll Free USA: [phone]
Phone: [phone]

Volk VistaView 3
1Product Description....................................................................
1.1 General.....................................................................................
1.2 Important Symbols...............................................................
1.3 Warnings and Cautions.......................................................
1.4 Contraindications of Use....................................................
1.5 Usage Environment Requirements..................................
1.6 Package Contents.................................................................
2Operating Instructions...............................................................
2.1 Unpacking the Product........................................................
2.2 Charging the Device..............................................................
2.3 Eye Cup Installation...............................................................
2.4 Powering On the Device.....................................................
2.5 Start Up Messages................................................................
2.6 Setting Up the VistaView App..........................................
2.7 Selecting a Patient................................................................
2.8 Capturing Images..................................................................
2.9 Reviewing Images and Adding Notes.............................
2.10 Creating a Report..................................................................
2.11 Managing Patients.................................................................
2.12 Exporting Patient Data.......................................................
2.13 Wireless Transfer of Patient Data.....................................
2.14 Wired Transfer to Windows PC........................................
2.15 Wired Transfer to Mac.........................................................
2.16 Updating the App.................................................................
2.17 Reinstalling the App.............................................................
3Maintenance...................................................................................
3.1 General Maintenance............................................................
3.2 Cleaning Instructions............................................................
Contents
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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 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.
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.

Volk VistaView 6
The device requires dilation of the patient’s eye for imaging.
1.3 Warnings and Cautions
The Volk VistaView should be used in accordance with the instructions,
warnings, and caution statements presented in this IFU for the most
eective and safe results. Before using the device, you must familiarize
yourself with all warnings, cautions, and with all sections of this IFU.
Specific warnings and cautions are also found throughout this IFU.
The symbol is accompanied by the name and the address of the
manufacturer.
Dispose of device in the proper manner and ensure to comply with all
laws and regulations applicable to your area.
Authorized representative in the European Community accompanied
by the name and the contact information of the authorized
representative.
Fragile, handle with care.
Keep dry.
Symbols found on and in the smartphone are not included. Please visit
the smartphone manufacturer website for instructions on how to use
the smartphone.
Radio frequency radiation: Electromagnetic interference may occur in
the vicinity of equipment.
Caution: Federal law restricts this device to sale by or on the order of a
physician or licensed practitioner.
The Volk VistaView device is only intended to be used for mydriatic
imaging of the retina.

Volk VistaView 7
Do not connect the device to computers, laptops, power supplies, or
electrical equipment while the device is inside the patient environment
(within 4 feet of the patient).
Only use the accessories and parts provided or specified by Volk
Optical with this product.
The device cannot be used to capture any images of the fundus while
plugged into a computer or power supply.
All servicing and repair of this equipment is to be performed by Volk
Optical Inc. or by a center approved by Volk Optical Inc. only.
The device is not intended to be sterilized using autoclave, ETO gas, or
any other sterilization means beyond the cleaning and sanitation
procedures discussed in Section 3. Maintenance on page 37 of this IFU.
User should not change the smartphone’s Bluetooth settings. The
Bluetooth connection should be active and connected automatically.
This is needed for the device to functional properly and must be
connected at all times. If there is an issue with Bluetooth settings,
please reference Section 6.1 Device Errors on page 48 of this IFU.
Only use the power supply provided in the sales package. If you need
a replacement power supply, please contact Volk Optical Inc. or your
local distributor.
No unauthorized modification of the device is allowed.
Only use cleaning instructions provided in Section 3. Maintenance on
page 37 of this IFU.
To avoid the risk of cross-contamination and irritation, clean the
eye cup after each patient exam using the cleaning instructions
provided in Section 3. Maintenance on page 37 of this IFU.
Deleting the pre-installed Volk VistaView smartphone application will
delete all patient data and images because the application stores all
the data in the encrypted application memory. The user should never
delete or uninstall the smartphone application o of the VistaView.
It is the responsibility of the user to make sure that they are exporting,
saving, and creating regular backups of data to prevent loss of data.
It is the responsibility of the user to keep track of the data export
password to prevent loss of data.

Volk VistaView 8
Avoid subjecting the device to vibrations or electrical shocks.
Do not submerge the device in liquid or allow liquid to enter the
interior of the device.
Do not expose the device to rain or high moisture environments.
Avoid using the device in a dusty environment.
The light emitted from this instrument is potentially hazardous by way
of causing ocular damage if the exposure duration exceeds 7 hours and
7 minutes of continuous use at the maximum setting.
1.5 Usage Environment
Requirements
The Volk VistaView is intended to be used indoors in normal
temperature and humidity conditions by trained professionals in
professional healthcare environments only.
Volk VistaView is not suitable for use in the presence of flammable
anesthetics and/or a mixture of air, oxygen, or nitrous oxide; in oxygen
enriched environments; or in any other potentially explosive/flammable
environment.
1.4 Contraindications of Use
To avoid prolonged light exposure, 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
and imaging of the target structures.
The Volk VistaView is classified as Group 1 light exposure limits based
on the standard ANSI Z80.36-2016. The Volk VistaView is classified as
Group 2 light exposure limits based on the standard ISO 15004-2:2007.
Avoid leaving the eye cup in direct sunlight, as there may be a risk of
skin burn.

Volk VistaView 9
Use only CE marked USB-C cables with this device.
Only connect the device to computers, laptops, and power supplies
outside the patient environment that have passed the safety standard
for information technology equipment IEC 60950-1, EN 60950-1, and
UL 60950-1 to ensure the safety of the USB-C electrical connection.
If operated within an electromagnetic environment, the device must be
used in accordance with instructions and guidelines set forth in Section
5. Compatibility and Compliance on page 41 of this IFU.
• Volk VistaView device
• Silicone eye cup
• Lens cap
• Volk VistaView IFU
• Volk VistaView Quick Start Guide
• Charger
• USB-C cable
• Volk VistaView case
1.6 Package Contents
The Volk VistaView product package includes the following items.

Volk VistaView 10
2.2 Charging the Device
Charge the device with the USB-C cable as shown, connecting one end
to the USB-C connector on the Volk VistaView and the other end to the
wall charger or USB-C on computer. When the device is fully charged,
disconnect the charger from the USB-C connector on the device.
2.3 Eye Cup Installation
Mount the eye cup onto the end of the VistaView as shown. Use of the
eye cup is optional as it helps block stray room light and stabilizes the
device during alignment.
2. Operating instructions
2.1 Unpacking the Product
Confirm that all purchased items are included in the packaged case,
and there is no visible damage to any of the parts.