Volk iNview User Manual

USER’S MANUAL / INSTRUCTIONS FOR USE

Volk iNview

Retinal Camera

Product description

The Volk iNview is an ophthalmic camera device to be used by healthcare professionals to acquire
wide-angle digital color images of the retina using an Apple iPhone or iPod Touch. Volk iNview is
a combination product comprised of a mobile application (app) and an indirect ophthalmoscopic
lens attachment for an Apple iPhone or iPod Touch.

The Volk iNview mobile app is accessible to users via the Apple App Store (Apple Inc.) for use on
select iOS devices; specifically, iPhone 5s and 6, or iPod Touch (6th Generation). The Volk iNview
mobile app, operating on an iPhone or iPod Touch, integrates with a mechanical adaptor with a
telescopic feature that houses a high-quality glass funduscopic lens. The combination of the
mobile app-powered smartphone / camera and the ophthalmoscope provide a clinician with the
ability to image the retina of the human eye using the native high-resolution camera and white­light LED of the iPhone or iPod Touch.

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Table of Contents

PRODUCT DESCRIPTION 2

1. PACKAGE CONTENTS 4

2. ACCESSORIES PURCHASED SEPARATELY 4

VOLK INVIEW CARRY CASE 4
PRECISION OPTICAL LENS CLEANER 4
VOLK LENS PEN 4

3. APPLICATION INSTRUCTIONS 5

LOADING THE APPLICATION 5

Personal iOS device 5
Prepackaged iOS device 5
Starting the Application 5

USING THE APPLICATION 6

Instructions for First Use of the Application 6
Adjusting Electronic Camera Device Settings 6
Using Application with Patient Information Encryption 7
Summary Checklist for Encrypted vs. Unencrypted mode 9
Calibrating the Camera 9
Undertaking an Image Session 10
Imaging Steps Summary 19

DATA EXPORT 19

4. INDICATIONS FOR USE 22

5. CONTRAINDICATIONS 22

6. WARNINGS AND PRECAUTIONS 22

EYE SAFETY 22

7. IMPORTANT SYMBOLS 23

8. ERROR MESSAGES 24

9. DEVICE PARTS 25

10. LABELING 26

11. CLEANING INSTRUCTIONS 27

12. TECHNICAL DESCRIPTION 28

Supported Electronic Camera Devices 28

13. INTELLECTUAL PROPERTY INFORMATION 29

Patents 29
Trademark 29

14. DISPOSING OF THE VOLK INVIEW 29

15. DEVICE CLASS 29

16. CONTACT 30

17. WARRANTY 31

Product Warranty 31

18. ORDERING INFORMATION 33

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1. Package contents

Part Number

Camera

Camera Supplied

VINVIEW-TCH

iPod Touch

None

VINVIEW-5S

iPhone 5S

None

VINVIEW-6

iPhone 6

None

VINVIEWC-TCH

iPod Touch

iPod Touch 6th Gen

Packaging contents will vary by part number:

Included as part of the electronic camera device (if supplied):

o USB power and sync cord
o Apple Wall Power Charger (US sockets)

2. Accessories purchased separately

Volk iNview Carry Case

Model Number: VINVIEW-CASE

Official Pelican Watertight and Dustproof Case – supplied with fitted foam interior

Volk Precision Optical Lens Cleaner

Model Number: VPOLC

Volk Precision Optical Lens Cleaner consists of a highly absorbent, lint-free optical towellete
moistened to an exact saturation level with a unique combination of oil removers and cleaning
agents.

http://www.volk.com/index.php/volk-products/accessories/lens-cleaner/precision-optical-lens­cleaner.html

Volk Lens Pen

Model Number: VLENSPEN

Volk LensPen ophthalmic lens cleaning instrument utilizes a remarkable lens cleaning compound
which removes finger prints, smudges and grease marks with ease.

http://www.volk.com/index.php/volk-products/accessories/lens-cleaner/lens-pen.html

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3. Application Instructions

This section contains instructions for setting up your new Volk iNview Retinal Camera, capturing
images, and exporting the images from the device.

Loading the application

Personal iOS device

1. Visit the App Store on your Apple device and download the application “Volk iNview.”

2. Place your device into the Volk iNview indirect lens holder as pictured in Figure 1, below.

Figure 1

Prepackaged iOS device

1. Charge the device fully before use.

2. Power on the iPod Touch using the Sleep button located on top of the electronic camera device.

3. Connect the camera WiFi your local network.

Note - Full instructions to connect to WiFi can be found on the Apple website.

Starting the Application

The Volk iNview software application is launched by selecting the Volk iNview application icon
(Figure 2).

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Figure 2

Using the application

Instructions for First Use of the Application

This section contains instructions for setting up the Volk iNview application for the first time. It is
strongly recommended that this section is read entirely before using your new Volk iNview.

Adjusting Electronic Camera Device Settings

During normal operation of the Volk iNview Retinal Imager, the electronic camera device display
(iPod Touch, iPhone 5s, or iPhone 6) is used to help the user to align the device with the patient’s
eye as well as to review acquired retinal images. To aid in these functions, it is recommended that
the display brightness setting of the electronic camera device be set to a fixed, full-brightness
setting. This can be done by accessing Settings  Display & Brightness where one could then turn
Auto-Brightness Off and position the brightness slider on High (Figure 3).

It is advantageous to restrict calls and texts from being pushed onto the electronic camera device
while it is being used to acquire retinal images. This can be accomplished by placing the electronic
camera device in Airplane Mode prior to taking retinal images.

Note – to receive access to software updates, the electronic camera device needs to establish
occasional access to the internet. This cannot be done while the device is in Airplane Mode unless WiFi
is enabled.

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Figure 3

Summary Check List

1. Turn device to airplane mode

2. Adjust Screen Brightness setting to maximum

3. Disable Auto-Brightness

Using Application with Patient Information Encryption

On first startup of the application, you will be presented with the choice to use the application in
either encrypted mode or unencrypted mode (Figure 4).

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Figure 4

IMPORTANT NOTE – THERE IS NO PASSWORD RESET AVAILABLE SHOULD THE ENCRYPTION KEY BE

FORGOTTEN. ALL DATA STORED WITHIN THE APPLICATION WILL BE LOST.

This is an important decision for the user. In the encrypted-mode, all of the patient imagery and
data is stored locally within the memory of the electronic camera device as encrypted data. The
encryption method that is used is sufficient to allow the Volk iNview Retinal Imager to meet
HIPAA requirements. To operate in an encrypted-mode, the user is required to provide a
password. Once an encryption password has been entered, the user is then required to enter that
same password every subsequent time the Volk iNview software application is launched. Failure
to enter the proper password will lock out non-authorized users.

Note – users who choose to operate the Volk iNview Retinal Imager in an encrypted-mode need to take
care ensuring that the entered password is securely retained. If an encryption password is ever
forgotten, the only recourse is to first delete the Volk iNview software application (and all the patient
data contained within the application), and then reload the Volk iNview application.

It is not possible to change from encrypted or unencrypted mode without deleting the application from
the iOS device. This will remove all images and patient data located in the application. Use the data
export function (see page 19).

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Summary Checklist for Encrypted vs. Unencrypted mode

Encrypted

Unencrypted

A password will be required
each time the application is
started.

Patient information and images
are encrypted. Data is stored
within the application.

Data is stored in a HIPAA
compliant manner.

No password will be required
when using the application.

Patient information and images
are not encrypted. Data is stored
within the application.

Data storage is not HIPAA
compliant.

Calibrating the Camera

The camera must be calibrated before imaging a patient for the first time.

After software initialization has taken place and the user has moved past Data Encryption
Selection, the user is presented with the Main Program Display (Figure 5).

Before the Volk iNview Retinal Imager can be used to acquire retinal images, the camera must first
be calibrated. The camera calibration process aligns the smart device field-of-view (FOV) and the
point of focus with the Primary Imaging Lens.

Note – the Volk iNview software application will only operate if the smart device in which it is installed
is used with / calibrated to a Volk-supplied iNview retinal imaging attachment.

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Figure 5

To calibrate the camera, the user selects the Camera Calibration icon from the Main Program
Display.

Figure 6

A dialog box then instructs the user to point the Volk iNview Retinal Imager (camera) at the
ground from at least 2 feet away. After a few seconds, a second dialog box will be presented that
indicates that the camera calibration has been successfully completed. After successful
calibration, the Volk iNview software application will be automatically exited. The iNview
software application needs to be re-launched for the camera calibration parameters to be
successfully applied.

Note – contact Volk if the camera calibration process fails to calibrate with your Volk iNview device.

Undertaking an Image Session

Note – the Volk iNview Retinal Imager requires that the patient’s pupil diameter be 5mm or greater.
The larger the patient pupil size, the easier it is to properly align the Volk iNview device to the patient’s

eye.

Imaging Technique

Utilizing the correct technique will make a great difference to the ease of imaging. The method of
holding the Volk iNview Retinal Imager when it is being used during an imaging session is
illustrated in Figure 7, below.

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Figure 7

This method allows access to the screen of the device while providing the best control of the
device to capture images.

o The device can be used with either the left or right hand at the front.
o The front hand should be placed on the lens grip at the very front of the device for the best

control.

Anyone trained to perform an eye examination using a Volk indirect BIO lens will be able to
quickly master operation of the Volk iNview Retinal Imager. The Primary Imaging Lens that is
used within the Volk iNview Retinal Imager is a 25D lens and it has a working distance of
approximately 50mm. The large end of the Lens Tube is fashioned like an indirect BIO lens with

the intention that the user position and stabilize the device using the patient’s forehead as a

steady reference as illustrated in Figure 8, below.

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Figure 2