Table of Contents
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Table of Contents
Related Manuals for Volk VistaView
Summary of Contents for Volk VistaView
- Page 1 Instructions for Use Hand-Held Mydriatic Fundus Camera Volk VistaView 1...
- Page 2 Volk VistaView ™ Instructions for Use for VistaView Hand-Held Mydriatic Fundus Camera Volk Optical Inc. 7893 Enterprise Drive Mentor, OH 44060 USA volk.com volk@volk.com Toll Free USA: +1 (800) 345-8655 Phone: +1 (440) 942-6161 Volk VistaView 2...
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Page 3: Table Of Contents
Charging the Device ............. Eye Cup Installation ..............Powering On the Device ..............Start Up Messages .......... Setting Up the VistaView App ..............Selecting a Patient ..............Capturing Images ..... Reviewing Images and Adding Notes ................2.10 Creating a Report .............. - Page 4 ..........Transportation Environment ............Expected Service Life ............Disposing of the Device Compatibility and Compliance..................Electromagnetic Compatibility ................Compliance Troubleshooting..............................Device Errors ................. Image Quality ..............System Messages Warranty................................Warranty Terms Support and Servicing............... Volk VistaView 4...
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Page 5: Product Description
The Volk VistaView requires the eye to be dilated and is intended to be used by trained professionals in professional healthcare environments only. -
Page 6: Warnings And Cautions
IFU. Specific warnings and cautions are also found throughout this IFU. The device requires dilation of the patient’s eye for imaging. The Volk VistaView device is only intended to be used for mydriatic imaging of the retina. Volk VistaView 6... - Page 7 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.
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Page 8: Contraindications Of Use
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. -
Page 9: Package Contents
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. 1.6 Package Contents The Volk VistaView product package includes the following items. • Volk VistaView device •... -
Page 10: Operating Instructions
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. -
Page 11: Powering On The Device
“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. - Page 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 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 password protected exports.
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Page 13: Setting Up The Vistaview App
2.6 Setting Up the VistaView 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 on page 48 of this IFU. - Page 14 Image Settings. The device has been calibrated and paired via Bluetooth during manufacturing by Volk, and 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 on page 48 of this IFU for troubleshooting tips.
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Page 15: Selecting A Patient
Manually check for application updates. About VistaView application version number. Support Link to online IFU, Terms and Conditions, Third Party Licenses, and Volk customer care contact information. Clear Patient Data Erase all patient information and images from the application. Calibrate Calibrate the VistaView imaging window. - Page 16 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. Volk VistaView 16...
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Page 17: Capturing Images
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. - Page 18 - the eye cup is flexible and the device will not touch the patient’s eye. If auto-focus is enabled, tap anywhere on the screen to focus, except for a button. A green box will appear when the retina is in focus. Volk VistaView 18...
- Page 19 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 19...
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Page 20: Reviewing Images And Adding 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. -
Page 21: Creating A Report
After a report is generated, the user has three options: Share the report via applications on the device, as shown below; Save & Close, which saves the report to the patient database inside the software application; or Edit to edit the report. Volk VistaView 21... -
Page 22: Managing Patients
View Report. If a report has not been generated, the user can select Generate Report. The user can also start a New Exam. A new exam does not overwrite existing data but adds an exam to a patient. Volk VistaView 22... -
Page 23: Exporting Patient Data
The user can turn off password protected export by tapping the lock. When a user taps the lock, a pop-up appears confirming that the user wants to export without a password. Select I Agree to turn off password protected export. Volk VistaView 23... - Page 24 An export bar will show the status of the export. Once the export is finished, a pop-up will inform the user of completion. Select View Now to view the exported data on the device. Select OK to dismiss the notification. Volk VistaView 24...
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Page 25: Wireless Transfer Of Patient Data
When the user selects View Now after exporting data or Go to Downloads from the export screen, the Download folder on the VistaView opens. Select the VistaView folder. Since wireless sharing is restricted to only files, folders must be compressed into a zip file if the user wants to share multiple patients. - Page 26 Share icon in the upper right-hand corner. The share menu pops up. Select the preferred method to share the zip file. The zip file is locked and needs a password to access. Only share the password with authorized individuals allowed to have access to patient data. Volk VistaView 26...
- Page 27 When the user selects View Now after exporting data or Go to Downloads from the export screen, the Download folder on the VistaView opens. Select the VistaView folder. Since wireless sharing is restricted to only files, folders must be compressed into a zip file if the user wants to share multiple patients.
- Page 28 A zip file appears named Unprotected Data.zip. If the user wants to rename the zip file, press and hold the Unprotected Data.zip file. Then, press the Menu icon and choose Rename. Type in a new name for the zip file and press OK. Volk VistaView 28...
- Page 29 > the date to share. Press and hold the images and reports until a check mark appears. Select the Share icon. The share menu pops up. Select the preferred method to share the zip file. Although the data is unprotected, the PDFs are still password protected. Volk VistaView 29...
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Page 30: Wired Transfer To Windows Pc
Open the Download folder followed by the VistaView folder. Protected Data To access patient data, follow the pathway moto g(6) > Internal shared storage > Download > VistaView. Copy the Protected Data folder to a desired location. Volk VistaView 30... - Page 31 Section 2.5 Start Up Messages on page 11 of this IFU. Image files are labeled as hhmmss_OD or hhmmss_OS where hh is hour, mm is minute, and ss is second. PDF files are labeled hhmmss. Volk VistaView 31...
- Page 32 Unprotected Data To access patient data, follow the pathway moto g(6) > Internal shared storage > Download > VistaView. Copy the Unprotected Data folder to a desired location. In the copied location, open Unprotected Data > the patient to access > the date to access. Image files are labeled as hhmmss_OD or hhmmss_OS where hh is hour, mm is minute, and ss is second.
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Page 33: Wired Transfer To Mac
Connect the device via USB-C cable to a Mac. Pull down from the top of the phone homepage to view the Android system options and select Tap for more options. Make sure to select the File Transfer option on this screen to connect the VistaView to a PC. Volk VistaView 33... - Page 34 Protected Data To access patient data, open the Android File Transfer application on the Mac. Follow the pathway Download > VistaView. Copy the Protected Data folder to a desired location. In the copied location, open Protected Data > the patient to access >...
- Page 35 Unprotected Data To access patient data, open the Android File Transfer application on the Mac. Follow the pathway Download > VistaView. Copy the Unprotected Data folder to a desired location. In the copied location, open Unprotected Data > the patient to access >...
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Page 36: Updating The App
If Wi-Fi is off and greyed out, select the icon to turn on Wi-Fi. Select Settings in the VistaView app then scroll down to select Check for Updates. If there is no update available, there will be a pop-up confirming the user is running the latest app. -
Page 37: Reinstalling The App
Section 2.16 Updating the App on page 36 of this IFU. If a file named VistaView.apk is not available here, make sure Wi-Fi is turned on. Swipe down from the top of the screen and select the left-most icon to turn on Wi-Fi if not already enabled. -
Page 38: Maintenance
If the device becomes non-functional or stops working as intended, do not attempt to repair or make changes to the device. Contact Volk Optical for support at volk@volk.com. Only Volk Optical is authorized to repair or make changes to the device. -
Page 39: Technical Description
78 x 185 x 102 mm Connector Type USB-C Device Power Rating 5 V (DC), 3 A Battery Capacity 3000 mAh Software VistaView smartphone application Operating system Android OS Compatible smartphone Motorola Moto G6 Switching Power Supply Motorola SC-22 Input: 100-240 V (AC), 50/60 Hz... -
Page 40: Operating And Storage Environments
Disposal of this product in an unlawful manner may have a negative impact on human health and on the environment. Do not dispose of the Volk VistaView as unsorted municipal waste. When disposing of this product, delete all patient data and follow the procedure which conforms with the laws and regulations applicable to your area. -
Page 41: Compatibility And Compliance
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Volk VistaView mydriatic fundus camera, including cables specified by the manufacturer. Otherwise, performance of this equipment could be degraded. - Page 42 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Volk VistaView mydriatic fundus camera is intended for use in the electromagnetic environment specified below. The customer or the user of the Volk VistaView mydriatic fundus camera should ensure that it is used in such an environment.
- Page 43 1 cycle 1 cycle tions, it is recommended that 70 % U 70 % U the Volk VistaView mydriatic 25/30 cycles h 25/30 cycles h fundus camera be powered Single phase: Single phase: from an uninterrupted power at 0°...
- Page 44 0.15 MHz – communications equipment 0.15 MHz – 80 MHz should be used no 80 MHz 6 Vrms in ISM closer to any part of the Volk 6 Vrms in ISM and amateur VistaView ophthalmic and amateur radio bands camera, including cables,...
- Page 45 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Volk VistaView mydriatic fundus camera is used exceeds the applicable RF compliance level above, the Volk VistaView mydriatic fundus camera should be observed to verify normal operation.
- Page 46 The Volk VistaView mydriatic fundus camera is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Volk VistaView mydriatic fundus camera can help prevent electromagnetic interference by maintaining a minimum distance between portable...
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Page 47: Compliance
5.2 Compliance The Volk VistaView complies with the following standards • IEC 60101-1:2005+A1:2012 • IEC 60601-1-2:2014 • ISO 10940:2009 • ISO 15004-2:2007 • ANSI Z80.36:2016 The FDA classification is Class II. The 93/42/EEC Medical Device Directive classification is Class I. -
Page 48: Troubleshooting
Volk Optical. visualization on device screen is acceptable. If the above solutions do not work, contact Volk Optical at volk@volk.com and we will be happy to assist you. Volk VistaView 48... -
Page 49: Image Quality
Adjust the angle of the device such that the face of the device is parallel to the patient. If issue persists, follow calibration steps on page 48 of this IFU. Volk VistaView 49... -
Page 50: System Messages
Press Allow to use the device for its intended purpose. Device has found a new version of VistaView software available for update. Updating the app will not delete any patient data but it is recommended to create a backup before updating. - Page 51 When the user attempts to delete an image, the user will see “Do you want to delete the selected image?” The user is prompted to choose between No to cancel the deletion and Yes delete the image. Volk VistaView 51...
- Page 52 The user is prompted to choose between deleting All Data or deleting Exam Data Only data (reports and studies). Deleting Exam Data Only leaves patient personal information intact for future appointments. Volk VistaView 52...
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Page 53: Warranty
7.1 Warranty Terms Volk provides a limited warranty against manufacturing defects for the VistaView for a period of one (1) year from the date of delivery of the VistaView to the customer. The obligation of Volk and the customer’s sole exclusive remedy hereunder, shall be limited, at Volk’s option, to replacement or repair of the defective VistaView unit. -
Page 54: Support And Servicing
Volk distributor, or a Volk-authorized e-commerce platform. In the event of a product recall during the warranty period, the VistaView will be replaced at no cost to the customer. Any repair for issues not covered by the above warranty may be conducted at the sole discretion of Volk at a cost to be determined by Volk. - Page 55 Volk Optical Inc. 7893 Enterprise Drive Mentor, Ohio 44060 Toll Free USA: +1 (800) 345-8655 Phone: +1 (440) 942-6161 Fax: +1 (440) 942-2257 Email: volk@volk.com Website: www.volk.com Copyright © 2020 Volk Optical Inc. IM-105 Revision: A Volk VistaView 55...
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Questions and answers
Hello dear Friend ,i have a problem with my vistaview ,,,, I Can not Seen the fondus if i launchenthe bluetooth seek
To resolve the issue of not seeing the fundus when launching Bluetooth on the Volk VistaView, follow these steps:
1. Ensure Bluetooth is On: Go to Phone Settings > Connected Devices > Connection Preferences > Bluetooth. Make sure the Bluetooth toggle is On.
2. Connect to the Correct Device: Seek devices and connect to the device named "Fundus I" using its 12-digit MAC address.
3. Calibrate the Device (if needed):
- Navigate to the device settings menu.
- Select the Calibrate function.
- Point the device at a flat white surface and press calibrate.
- Only use this function if instructed by Volk Optical.
If these steps do not solve the issue, contact Volk Optical for further assistance.
This answer is automatically generated