Volk Eye Check User manual

INSTRUCTIONS FOR USE
Volk® Eye Check
Ophthalmic Measurement Device

IM-078 Rev. F
Page 2 of 42 1
Shipping Contents
Item:
Part Number:
Description:
Volk Eye Check
18343-US
Ophthalmic measurement device
USB Cord
18338
For charging and data transmission
Power Adaptors
18339-US
For charging Volk Eye Check in a wall outlet
(Formats Supplied: USA)
Stylus
18349
For precise interaction with touch screen
Protective Case
18345
Case for Volk Eye Check
Protective Pouch
18346
Microfiber Pouch for Volk Eye Check
Quick Start Guide*
ML-1016
Abbreviated instructions
Registration Card
IM-081
Please fill out and return to Volk Optical
Optional Accessories
The Volk Precision Stickers are an accessory for Volk Eye Check which act as a positioning target aid. They also
remove the need to input patient IPD at the start of a session.
After removing from the backing strip, the sticker is placed on the patient’s forehead. On completion of the
session, the sticker is discarded.
Model:
Part Number:
Description:
Precision Sticker Pack
VLKSTKR
Volk Precision Stickers x72
Further copies of the Volk Eye Check Instructions For Use for the Volk Eye Check (This
document) and for the Volk Precision Stickers can be found at:
http://volk.com/eyecheck/literature/
Preparation for First Use
1. Remove Volk Eye Check from the package and check that all parts present are undamaged.
2. Sterilization or calibration prior to first use is not required.
3. Connect Volk Eye Check to the mains using the USB cord and the appropriate power adaptor.
4. The battery will start to charge.
5. Safely place Volk Eye Check on a flat surface.
6. Charge battery for at least 3 hours before the first use.

IM-078 Rev. F
Page 3 of 42 1
Table of Contents
Shipping Contents....................................................................................................................................... 2
Optional Accessories................................................................................................................................... 2
Preparation for First Use............................................................................................................................. 2
Intended Use............................................................................................................................................... 4
Indications for Use ...................................................................................................................................... 4
Recommendations Prior to Use.................................................................................................................. 4
Contraindications for Use ........................................................................................................................... 4
Warnings ..................................................................................................................................................... 4
Cautions ...................................................................................................................................................... 4
Important Symbols...................................................................................................................................... 5
Hardware Controls and Connectors ........................................................................................................... 6
Soft Controls ............................................................................................................................................... 7
Environment and Photo-Taking Indicators................................................................................................. 8
Preparation ................................................................................................................................................. 9
Language Selection ..................................................................................................................................... 9
Initial Settings............................................................................................................................................ 10
Device Settings.......................................................................................................................................... 11
Authorisation Code ................................................................................................................................... 12
Application Settings .................................................................................................................................. 13
Basic Use –Start Up, Shut Down, and Capturing an Image...................................................................... 15
Operational Modes –“Eye Check”, “Contact Lens” and “Oculoplastics”................................................. 16
Capturing a Patient Session ...................................................................................................................... 16
Measurements Provided by the Volk Eye Check Device .......................................................................... 21
Reviewing Patient Measurement Data..................................................................................................... 24
WiFi Upload............................................................................................................................................... 25
Pre-loading Patient details........................................................................................................................ 29
Adding a Patient Database........................................................................................................................ 29
Starting a new session for a patient already in the database .................................................................. 31
Freestyle Mode ......................................................................................................................................... 31
How to update Volk Eye Check Software ................................................................................................. 33
System Messages...................................................................................................................................... 34
Cleaning Instructions ................................................................................................................................ 35
Device Maintenance and Servicing........................................................................................................... 35
Calibration................................................................................................................................................. 36
EN 62479................................................................................................................................................... 36
Technical Description................................................................................................................................ 37
Environmental Conditions for Use, Storage and Transportation ............................................................. 38
Serial numbering....................................................................................................................................... 38
Intellectual Property Rights Information.................................................................................................. 39
Disposing of Volk Eye check...................................................................................................................... 39
Contact for Product Support..................................................................................................................... 39
Warranty ................................................................................................................................................... 39
Appendix A –FCC Statement .................................................................................................................... 40
Appendix B –Replacing the AAA Batteries............................................................................................... 41

IM-078 Rev. F
Page 4 of 42 1
Intended Use
Volk Eye Check is standalone ophthalmic software, loaded on a mobile electronic platform that is intended to
measure ophthalmic characteristics and to aid in the diagnosis of ophthalmic abnormalities.
Indications for Use
To be used by Ophthalmologists, Optometrists, and other trained health care professionals. Clinical support staff
can also use Volk Eye Check.
Recommendations Prior to Use
It is highly recommended that all persons, eye care specialists and healthcare professionals or clinical support
staff, thoroughly review this document prior to patient usage. Interpretation of the measurement data generated
is advised for eye care specialists and healthcare professionals only. There are no special facilities or qualifications
required relating to the device.
Contraindications for Use
Some patients may experience momentary discomfort when exposed to flash photography. Use of Volk Eye Check
on patients with photosensitive epilepsy is at the discretion and professional judgment of the healthcare
professional.
Warnings
There are no medicinal substances or biological materials incorporated within this device.
No personal protective equipment is required to be worn by the user or the patient when using this device.
Cautions
Use only accessories and Li-ion batteries provided by Volk Optical with this product.
Any good-quality Alkaline AAA batteries may be used in the Fixation Target.
No modification of this equipment is allowed.
No files may be copied to/from the device except as described later in this document.

IM-078 Rev. F
Page 5 of 42 1
Important Symbols
Symbol
Description
The CE mark on this product indicates it has been tested and conforms to
the provisions noted within the 93/42 EEC Medical Device Directives.
The CE mark with notified body identification number indicates a Class I
(measuring) product.
The FCC Declaration of Conformity, or the FCC label, or the FCC mark, is a
certification mark employed on electronic products manufactured or sold
in the United States which certifies that the electromagnetic interference
from the device is under limits approved by the Federal Communications
Commission.
Do not dispose of Volk Eye Check or Volk Eye Check’s battery (Lithium-
Ion) as unsorted municipal waste.
Li-ion
Recycle Volk Eye Check’s Lithium-Ion battery.
Read accompanying user documentation. Indicates that important
operating instructions are included in this User Manual. Failure to follow
these instructions could place the patient or operator at risk.

IM-078 Rev. F
Page 6 of 42 1
Hardware Controls and Connectors
Things that are found on the device itself:
Position
Indicator
Purpose
1
Back of device
----
INTERACTIVE TOUCH SCREEN
Shown is the Eye Check software “Home” screen.
2
Left side of device
(viewed from the back)
POWER –Physical button
Power on the device with long press.
3
Top right of device
----
SHUTTER –Physical button
Half-press - Locks the focus and exposure.
Full-press - Takes a photo.
4
Top left of device
ATTRACT –Physical button
To activate the fixation target (See item 10).
5
Back of device
BACK KEY –Physical button
To go back to the previous screen.
6
Back of device
HOME KEY –Physical button
To return to the Mode Selection Screen.
7
Bottom of device
----
USB CONNECTOR
Micro USB connector used for charging and data transfer.
8
Front of device
FLASH
Automatically illuminates the subject when taking pictures.
9
Front of device
LENS
Camera lens. Patients should look directly at the center of the
lens when the device is used in CL or OP mode.
10
Front of device
FIXATION TARGET
Flashes when activated by the Attract Button (See item 4), the
patient should look at this when using Eye Check mode.

IM-078 Rev. F
Page 7 of 42 1
Soft Controls
These controls will be found on the interactive touch screen and will change depending on mode:
Icon
Purpose
Eye Check Selects Eye Check (EC) mode when in the Mode Selection screen.
Mode Icon: Displays the regulatory labels when in the EC Patient Details screen.
Returns to EC Patient Details screen when in any other EC screen.
Contact Lens Selects Contact Lens (CL) mode when in the Mode Selection screen.
Mode Icon: Displays the regulatory labels when in the CL Patient Details screen.
Returns to CL Patient Details screen when in any other CL screen.
Oculoplastics Selects Oculoplastics (OP) mode when in the Mode Selection screen.
Mode Icon: Displays the regulatory labels when in the OP Patient Details screen.
Returns to OP Patient Details screen when in any other OP screen.
Start: Short press: Initiates a new session and enters capture mode.
Long press: Choose - normal or freestyle session or save patient details.
Attract: Plays a random sound when in picture capture mode.
Note: Audio needs to be enabled in Application Settings for icon to be visible.
Review: Initiates patient data review mode from the Patient Details or Capture screens.
Upload: Indicates the upload status of the selected session –
Red –not uploaded
Amber –upload in progress
Green –upload complete
Application Opens the Eye Check settings screen where upload, reporting and audio
Settings: features can be configured.
Session When pressed will generate and save a report file for the current session.
Report: Note: This control is only visible if the report file does not exist.
Help: Long press: Activates the help dialog.
Back: Go back to the previous screen.

IM-078 Rev. F
Page 8 of 42 1
Environment and Photo-Taking Indicators
These indicators are displayed on the interactive touch screen while taking pictures:
Indicator
Purpose
Good photos: Indicates number of valid photos in current session.
Poor photos: Indicates number of poor photos in current session.
Correct distance: Optimal patient-practitioner distance.
Distance too far: Face too small, move closer to patient.
Distance too close: Too close to patient, move back.
Brightness level: Optimum level is between 70 and 80.
Zoom: Lens zoom setting. Preset to Z5.
Battery: Indicates percentage remaining battery charge.
Gaze indicator –EC: Displayed when in Eye Check mode to remind the user that the
subject’s gaze should be directed to the fixation target.
Gaze indicator –CL & OP: Displayed when in Contact Lens or Oculoplastics mode to remind
the user that the subject’s gaze should be directed to the center of the lens

IM-078 Rev. F
Page 9 of 42 1
Preparation
Volk Eye Check can be charged by connecting the supplied USB cable to either a PC (Personal Computer) or the
appropriate mains power adaptor. When not using Volk Eye Check, it is recommended that the device is
completely shut down. The device will not function if the remaining battery charge falls below 15%.
Language Selection
Once the Eye Check device is prepared for first use, power it on with a long press on the power button. The
following screen will be displayed –
First-time run language selection screen
Select the desired language by touching the appropriate button. The device will be set to default to that
language and the Volk Eye Check Mode Selection Screen will be displayed.
NOTE:
Language selection is only possible during the very first use of the device. For
information on changing the selected language please contact Volk support at
[email protected]m.

IM-078 Rev. F
Page 10 of 42 1
Initial Settings
If not already on, power-up the device on with a long press on the power button. After completing a short self-
test, the Volk Eye Check Mode Selection screen will appear.
Mode Selection Screen
Swipe left on the Mode Selection screen to display the Utility screen
Utility Screen
Swipe right on the Utility screen to return to the Mode Selection screen.