Volk VISTA VIEW 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 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 Transfer Patient Files...........................................................
2.13 Wireless Transfer of Patient Data.....................................
2.14 Wired Transfer to Windows PC........................................
2.15 Wired Transfer to Mac.........................................................
2.16 Re-encrypting Patient Data...............................................
2.17 Disable Encryption................................................................
3Maintenance...................................................................................
3.1 General Maintenance............................................................
3.2 Cleaning Instructions............................................................
Contents
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5
5
6
8
8
9
10
10
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10
11
11
13
17
18
21
22
23
24
26
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30
32
33
37
39
39
2.18 Sync Files for Export............................................................ 34
2.19Updating the App.................................................................. 35
2.20 Reinstalling the App............................................................. 36

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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38
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40
46
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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.

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...............................................................
40
40
41
41
41
41
42
42
48
49
49
50
51
54
54
55
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.

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.
Prescription Device symbol. 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
It is the responsibility of the user to make sure that they are creating
regular backups of data to prevent loss of data.
It is the responsibility of the user to keep track of the data encryption
password to prevent loss of data.
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.
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 of this IFU.
Only use the accessories and parts provided or specified by Volk
Optical with this product.
No unauthorized modification of the device is allowed.
Only use the power supply provided in the sales package or a
certified ITE-grade power supply. If you need a replacement power
supply, please contact Volk Optical Inc. or your local distributor.
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).
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.
Only use cleaning instructions provided in Section 3. Maintenance of
this IFU.
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 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 of 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.
Prescription Device symbol. 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
It is the responsibility of the user to make sure that they are creating
regular backups of data to prevent loss of data.
It is the responsibility of the user to keep track of the data encryption
password to prevent loss of data.
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.
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 of this IFU.
Only use the accessories and parts provided or specified by Volk
Optical with this product.
No unauthorized modification of the device is allowed.
Only use the power supply provided in the sales package or a
certified ITE-grade power supply. If you need a replacement power
supply, please contact Volk Optical Inc. or your local distributor.
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).
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.
Only use cleaning instructions provided in Section 3. Maintenance of
this IFU.
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 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 of this IFU.

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 of this IFU.
• Volk VistaView device
• Silicone eye cup
• Lens cap
• Volk VistaView IFU
• Volk VistaView Quick Start Guide
• Charger
•International plug adapters
• USB-C cable
• Volk VistaView case
1.6 Package Contents
The Volk VistaView product package includes the following items.

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 of this IFU.
• Volk VistaView device
• Silicone eye cup
• Lens cap
• Volk VistaView IFU
• Volk VistaView Quick Start Guide
• Charger
•International plug adapters
• 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.
Volk VistaView 11
2.4 Powering On the Device
Power on the device by pressing the power button as shown.
The default password is 1234. To change the password, navigate to
phone settings by swiping down from the top of the screen, clicking
the settings gear button, and searching for “screen lock”.
2.5 Start Up Messages
Once the device is on, navigate to the VistaView application installed
on the device. The home screen should be visible on the screen as
shown below.

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.
Volk VistaView 11
2.4 Powering On the Device
Power on the device by pressing the power button as shown.
The default password is 1234. To change the password, navigate to
phone settings by swiping down from the top of the screen, clicking
the settings gear button, and searching for “screen lock”.
2.5 Start Up Messages
Once the device is on, navigate to the VistaView application installed
on the device. The home screen should be visible on the screen as
shown below.

Volk VistaView 12
Upon set up, the application will request user to carefully read and
understand the Volk Optical Inc. VistaView™ Terms and Conditions.
The user must scroll to the bottom and select I Understand and Agree
before proceeding.
After agreeing to the Volk Optical Inc. VistaView™ Terms and
Conditions, the user is informed of warnings associated with
encrypted file storage and password protected report. Ensure that the
password is stored in a safe location and only share the password with
trusted individuals. Select
I Understand to continue.
Please note that it is the responsibility of the user to use the data
export in a manner compliant with their practices.
The user is prompted to input a password at least 8 characters long
with at least one of each of the following: upper-case letter, lower-case
letter, number, and special character.
Please note that it is the responsibility of the user to store the
password in a safe location to avoid loss of any data.
Volk VistaView 13
For best results when using the Voice AAccttiivvaattiioonn feature on the
VistaView, the user can train the device to recognize their voice and
pronunciation of the word “Capture” and "Focus". Press Continue to
begin training. When you are ready, tap the microphone icon and
repeat the word “Capture” five (5) times, following repeat the word
"Focus" five (5) times. The screen will update after each successful
training attempt. You can also repeat this training at any time by
following the steps under Train Voice Commands Settings in the next
section of this IFU.
2.6 Setting Up the VistaView
App
Before starting an imaging session with a patient, the user must always
check that the device status is Active in the bottom left-hand corner
on the home screen. If the device status is Inactive, please refer to the
troubleshooting tips in Section 6.1 Device Errors of this IFU.

Volk VistaView 12
Upon set up, the application will request user to carefully read and
understand the Volk Optical Inc. VistaView™ Terms and Conditions.
The user must scroll to the bottom and select I Understand and Agree
before proceeding.
After agreeing to the Volk Optical Inc. VistaView™ Terms and
Conditions, the user is informed of warnings associated with
encrypted file storage and password protected report. Ensure that the
password is stored in a safe location and only share the password with
trusted individuals. Select
I Understand to continue.
Please note that it is the responsibility of the user to use the data
export in a manner compliant with their practices.
The user is prompted to input a password at least 8 characters long
with at least one of each of the following: upper-case letter, lower-case
letter, number, and special character.
Please note that it is the responsibility of the user to store the
password in a safe location to avoid loss of any data.
Volk VistaView 13
For best results when using the Voice AAccttiivvaattiioonn feature on the
VistaView, the user can train the device to recognize their voice and
pronunciation of the word “Capture” and "Focus". Press Continue to
begin training. When you are ready, tap the microphone icon and
repeat the word “Capture” five (5) times, following repeat the word
"Focus" five (5) times. The screen will update after each successful
training attempt. You can also repeat this training at any time by
following the steps under Train Voice Commands Settings in the next
section of this IFU.
2.6 Setting Up the VistaView
App
Before starting an imaging session with a patient, the user must always
check that the device status is Active in the bottom left-hand corner
on the home screen. If the device status is Inactive, please refer to the
troubleshooting tips in Section 6.1 Device Errors of this IFU.

Volk VistaView 14
Once the application has started, navigate to the settings menu by
selecting the Settings icon in the top right-hand corner, as shown. It is
recommended that the user only change or update the Clinic Settings,
Image Settings, Export Settings, and Voice Capture.
Clinic Settings
The user can add and edit clinic information in Clinic Settings to
organize information and data obtained from multiple clinics. To add a
clinic, select Add Clinic under the Clinic Settings.
Image Settings
The user can change Image Settings to export either JPEG or DICOM
compressed images and raw images.
If DICOM files are needed, choose the DICOM setting before imaging.
Images cannot be converted to DICOM after imaging.
The Raw Image Acquisition setting allows the user to automatically
export the raw images in a digital negative format (DNG) that
correspond to the compressed JPEG or DICOM images. If raw image
export is turned O, the user risks losing raw image traceability.
Export Settings
The user can change Export Settings to enable or disable encrypted
file storage. To change the password for password encrypted file
storage and the patient report password, select Change Password.
Input the old password, enter a new password, and confirm new
password.
It is the responsibility of the user to keep track of passwords to avoid
loss of data.
Volk VistaView 15
Factory Reset
The Factory Reset option deletes all patient data from the application
memory and from the exported data folder. Transfer patient data to a
PC, as well as a safe location, before performing Factory Reset to avoid
loss of important data.
Factory Reset resets all user settings, except Bluetooth and
Calibration Settings. Factory Reset can be used to reset the encrypted
file storage and patient report password if it is lost or forgotten, but
will lead to loss of all data.
Train Voice Commands Settings
For best results when using the Voice AAccttiivvaattiioonnfeature on the
VistaView, the user can train the device to recognize their voice and
pronunciation of the word “Capture” and "Focus". To train the device,
select Train Capture or Train Focus under Train Voice Commands. If
Train Capture selected, repeat the word “Capture” five (5) times, if
Train Focus selected repeat the word "Focus" five (5) times when
prompted.
Default Settings
The screenshots below indicate the default settings for Clinic Settings
and Image Settings.
The device has been calibrated and paired via Bluetooth during
manufacturing by Volk. The user is advised not to change the
Calibrate or Bluetooth settings unless instructed to do so by Volk
Optical customer care.
Please reference Section 6.1 Device Errors of this IFU for
troubleshooting tips.

Volk VistaView 14
Once the application has started, navigate to the settings menu by
selecting the Settings icon in the top right-hand corner, as shown. It is
recommended that the user only change or update the Clinic Settings,
Image Settings, Export Settings, and Voice Capture.
Clinic Settings
The user can add and edit clinic information in Clinic Settings to
organize information and data obtained from multiple clinics. To add a
clinic, select Add Clinic under the Clinic Settings.
Image Settings
The user can change Image Settings to export either JPEG or DICOM
compressed images and raw images.
If DICOM files are needed, choose the DICOM setting before imaging.
Images cannot be converted to DICOM after imaging.
The Raw Image Acquisition setting allows the user to automatically
export the raw images in a digital negative format (DNG) that
correspond to the compressed JPEG or DICOM images. If raw image
export is turned O, the user risks losing raw image traceability.
Export Settings
The user can change Export Settings to enable or disable encrypted
file storage. To change the password for password encrypted file
storage and the patient report password, select Change Password.
Input the old password, enter a new password, and confirm new
password.
It is the responsibility of the user to keep track of passwords to avoid
loss of data.
Volk VistaView 15
Factory Reset
The Factory Reset option deletes all patient data from the application
memory and from the exported data folder. Transfer patient data to a
PC, as well as a safe location, before performing Factory Reset to avoid
loss of important data.
Factory Reset resets all user settings, except Bluetooth and
Calibration Settings. Factory Reset can be used to reset the encrypted
file storage and patient report password if it is lost or forgotten, but
will lead to loss of all data.
Train Voice Commands Settings
For best results when using the Voice AAccttiivvaattiioonn feature on the
VistaView, the user can train the device to recognize their voice and
pronunciation of the word “Capture” and "Focus". To train the device,
select Train Capture or Train Focus under Train Voice Commands. If
Train Capture selected, repeat the word “Capture” five (5) times, if
Train Focus selected repeat the word "Focus" five (5) times when
prompted.
Default Settings
The screenshots below indicate the default settings for Clinic Settings
and Image Settings.
The device has been calibrated and paired via Bluetooth during
manufacturing by Volk. The user is advised not to change the
Calibrate or Bluetooth settings unless instructed to do so by Volk
Optical customer care.
Please reference Section 6.1 Device Errors of this IFU for
troubleshooting tips.

Volk VistaView 16
It is the responsibility of the user to make sure they are creating
regular backups of data to prevent loss of data, especially before a
factory reset.
Setting
Clinic Settings
Function
Add and edit clinic information to
organize information and data obtained
from multiple clinics.
Adjust JPEG quality, enable DICOM
export and enable Raw Image
Acquisition.
Change encrypted data storage and
patient report password and turn off
encrypted data storage.
Manually check for application updates.
VistaView application version number.
Link to online IFU, Terms and Conditions,
Third Party Licenses, and Volk customer
care contact information.
Erase all patient information and images
from the application.
Calibrate the VistaView imaging window.
Train the device to better recognize the
word “Capture” as said by the user during
voice activated image capture.
Pairing and connection to device.
Reset all data and settings.
Image Settings
Export Settings
Check for Updates
About
Support
Clear Patient Data
Calibrate
Voice Capture
Bluetooth Factory
Reset
Volk VistaView 17
When imaging an existing patient, search the patient database and
select the patient to image.
Once all details have been entered, select Save and Begin Imaging to
proceed to the imaging screen.
2.7 Selecting a Patient
Select Start Imaging on the home screen. Choose between New Patient
and Existing Patients depending on the patient being examined.
When imaging a new patient, enter the requested patient information.
Mandatory fields are First Name, Last Name, Patient ID, Gender, Date
of Birth, and “Imaged By” (name of operator/user). Each patient should
have a unique Patient ID.

Volk VistaView 16
It is the responsibility of the user to make sure they are creating
regular backups of data to prevent loss of data, especially before a
factory reset.
Setting
Clinic Settings
Function
Add and edit clinic information to
organize information and data obtained
from multiple clinics.
Adjust JPEG quality, enable DICOM
export and enable Raw Image
Acquisition.
Change encrypted data storage and
patient report password and turn off
encrypted data storage.
Manually check for application updates.
VistaView application version number.
Link to online IFU, Terms and Conditions,
Third Party Licenses, and Volk customer
care contact information.
Erase all patient information and images
from the application.
Calibrate the VistaView imaging window.
Train the device to better recognize the
word “Capture” as said by the user during
voice activated image capture.
Pairing and connection to device.
Reset all data and settings.
Image Settings
Export Settings
Check for Updates
About
Support
Clear Patient Data
Calibrate
Voice Capture
Bluetooth Factory
Reset
Volk VistaView 17
When imaging an existing patient, search the patient database and
select the patient to image.
Once all details have been entered, select Save and Begin Imaging to
proceed to the imaging screen.
2.7 Selecting a Patient
Select Start Imaging on the home screen. Choose between New Patient
and Existing Patients depending on the patient being examined.
When imaging a new patient, enter the requested patient information.
Mandatory fields are First Name, Last Name, Patient ID, Gender, Date
of Birth, and “Imaged By” (name of operator/user). Each patient should
have a unique Patient ID.

Volk VistaView 18
Note: If no clinic has been set up, the device will prompt the user to
add a clinic. Select Yes to set up a clinic before proceeding or select
No to proceed without a clinic. Check Don’t Ask Me Again if you do
not want to see this message again. The user can still add a clinic by
accessing the clinic settings through the settings gear icon on the
home screen.
2.8 Capturing Images
On the imaging screen, select desired settings. The focus mode and
brightness are user adjustable.
To adjust the focus mode, select the Focus icon then select Focus
Assist, or Manual mode.
To adjust the brightness, select the Brightness icon. Start with the
lowest brightness and increase as needed.
If needed, turn on the Voice Activation feature by activating the
toggle button, as shown. Simply say the word “Focus” to focus and
lock the focus, say the word "Capture" to capture an image once
lined up and the retina is in full field. Voice activation feature best
performs when the user trains their VistaView to recognize their
voice by saying "capture" and "focus" five times during the first use
of the application or at any time through the VistaView settings.
To image a patient, the patient and examiner should be seated facing
each other. Use your dominant hand to hold the VistaView and use
your non-dominant hand to stabilize the device by positioning the
fingers just behind the eye cup.
Volk VistaView 19
Ask the patient to look over your shoulder or to fixate at a spot near
your ear. Approach the pupil, keeping the device vertical and in a
portrait orientation. Slowly, move the device closer to the eye while
keeping the pupil in the center of the screen. Locate the retina, which
can be seen as a small reflection within the pupil. If focus-assist is
enabled, tap press to focus button or on the screen or say "focus"
when you can see the optic disk. The right focus is then locked for the
eye. When you the focus is locked, if needed, you can readjust the
position of the camera. Keep the retina reflection in the middle of the
display screen and slowly advance the device closer to the patient’s
eye. As you move closer, stabilize by resting your fingers on the
patient’s forehead.
The correct imaging distance is reached when the retina completely
fills the imaging window. Do not be afraid to gently push the device
closer to the patient to fill the field of view- the eye cup is flexible
and the device will not touch the patient’s eye.
If using manual focus, use the buttons on the right-hand side of the
screen to increase or decrease the focus by one diopter increments
to match the patient's refractive power before you begin imaging.

Volk VistaView 18
Note: If no clinic has been set up, the device will prompt the user to
add a clinic. Select Yes to set up a clinic before proceeding or select
No to proceed without a clinic. Check Don’t Ask Me Again if you do
not want to see this message again. The user can still add a clinic by
accessing the clinic settings through the settings gear icon on the
home screen.
2.8 Capturing Images
On the imaging screen, select desired settings. The focus mode and
brightness are user adjustable.
To adjust the focus mode, select the Focus icon then select Focus
Assist, or Manual mode.
To adjust the brightness, select the Brightness icon. Start with the
lowest brightness and increase as needed.
If needed, turn on the Voice Activation feature by activating the
toggle button, as shown. Simply say the word “Focus” to focus and
lock the focus, say the word "Capture" to capture an image once
lined up and the retina is in full field. Voice activation feature best
performs when the user trains their VistaView to recognize their
voice by saying "capture" and "focus" five times during the first use
of the application or at any time through the VistaView settings.
To image a patient, the patient and examiner should be seated facing
each other. Use your dominant hand to hold the VistaView and use
your non-dominant hand to stabilize the device by positioning the
fingers just behind the eye cup.
Volk VistaView 19
Ask the patient to look over your shoulder or to fixate at a spot near
your ear. Approach the pupil, keeping the device vertical and in a
portrait orientation. Slowly, move the device closer to the eye while
keeping the pupil in the center of the screen. Locate the retina, which
can be seen as a small reflection within the pupil. If focus-assist is
enabled, tap press to focus button or on the screen or say "focus"
when you can see the optic disk. The right focus is then locked for the
eye. When you the focus is locked, if needed, you can readjust the
position of the camera. Keep the retina reflection in the middle of the
display screen and slowly advance the device closer to the patient’s
eye. As you move closer, stabilize by resting your fingers on the
patient’s forehead.
The correct imaging distance is reached when the retina completely
fills the imaging window. Do not be afraid to gently push the device
closer to the patient to fill the field of view- the eye cup is flexible
and the device will not touch the patient’s eye.
If using manual focus, use the buttons on the right-hand side of the
screen to increase or decrease the focus by one diopter increments
to match the patient's refractive power before you begin imaging.
As you move closer, stabilize by resting your fingers on the
patient’s forehead.

Volk VistaView 20
To capture an image, ensure that the retina fills up the full field-of-
view and is illuminated with no dark spots, reflections, or shaded
regions appearing toward the boundaries during preview. Press the
Capture button on screen. The device will flash and capture an image.
If Voice Activation is on, take an image by saying the word
“Capture”.
N
Noottee:: Inform the patient that they will see a bright flash of light and
to keep their eyes open. This will help prepare them and attempt to
avoid reflex movements that may compromise the image.
An image preview will appear. The user can zoom into the image by
spreading two fingers to check for quality before accepting the image
and assigning it to the OD (right) eye, or the OS (left) eye, or to reject
the image. All options return the user to the imaging screen where
more images can be captured if desired.
Volk VistaView 21
On the patient exam review screen, the user can tap on the thumbnail
to enlarge the image. The user can also spread and pinch to zoom in
and out of the image.
Checking the red free box below the image adds a red free version of
the original retina image for ease of analysis if needed.
Tap the Delete icon to delete the image from the device if needed.
2.9 Reviewing Images and
Adding Notes
Once all images have been captured, select Done on screen, which will
take the user to the patient exam review screen.
On the patient exam review screen, the user can add optional notes.
The user is responsible for the accuracy of any notes.
The content of exam notes represents the opinion of the person
who entered the notes, and does not reflect the opinions, views, or
recommendations of Volk Optical Inc.
The user will be required to fill “Noted By” (name of operator/user) if
notes are added. Then, select Generate Report or Home.
Report notes cannot be edited or deleted once saved to enhance
traceability. Additional notes can be added.