Intended Use ....................................................................................................................................................... 3
Indications for Use .......................................................................................................................................... 3
Basic Care .............................................................................................................................................................. 5
Powering the vision screener On and Off .......................................................................................... 7
Tripod Mount ..................................................................................................................................................... 7
User Operation ............................................................................................ 8
Main Menu – Home Screen ......................................................................................................................... 8
Screening a Subject ......................................................................................................................................... 9
How to Focus the vision screener ......................................................................................................... 10
Viewing the Results ....................................................................................................................................... 11
Understanding the Results ........................................................................................................................ 11
Web Access ........................................................................................................................................................ 20
EMC Information ........................................................................................................................................... 25
Welcome to the Welch Allyn Vision Screener.The Directions for Use are designed to assist you, the
user, in making the most of your screening experience.
Intended Use
The vision screener is intended to measure the refractive power of the eye by measuring light
reflexes from the retina. It also estimates pupil size, pupil distance and eye gaze deviation. It is
intended for use on subjects six months of age through adults.
Indications for Use
The vision screener is indicated for use by healthcare professionals or under the direction of a
healthcare professional to screen or evaluate individuals for potential refractive errors associated
with poor vision.
Box Contents
The main shipping box contains the vision screener,
Instructions for Use, and the Accessory box. The
Accessory box contains:
1. AC Power Cord
2. Power Supply/Charger
3. Cleaning Cloth
4. Velcro Cable Straps
NOTE: Please do not discard the box and foam.
Damages incurred by shipping the device in nonapproved packing material will void the limited
warranty (see page 33 for warranty details).
If you purchased a carrying case, place the foam from the shipping box inside the carrying case for
safer transport. Do NOT store your vision screener in the foam or case while the Power cord is
plugged in.
P/N 20146 Rev A Page 3
Figure 3
Figure 2
Device Description
The vision screener is a hand-held instrument with a video display on the rear of the unit that
provides subject visualization and alignment. Video display also provides user interface
functionality for data input and display. Operation is as simple as using a digital point and shoot
camera. The vision screener provides visual and audible cues to attract subject’s attention and
gaze. The device provides a fast data collect for easy evaluation of the most difficult pediatric
subjects of limited compliance. Each evaluation provides simultaneous binocular assessment of the
subject’s refraction, pupil size and gaze.
BBaassiicc OOppeerraattiioonn
Terminology – Device Details
NOTE: The USB port will only be used for software installations and import/export of vision
screener data via a USB flash drive. No cable connection to any other device is permissible.
P/N 20146 Rev A Page 4
Basic Care
1. The vision screener is a precision instrument. DO NOT drop it or subject it to physical shock.
2. The vision screener is NOT waterproof. If you accidentally drop it into liquid or liquid is spilled on the
device, contact Welch Allyn Support immediately. If minor water droplets are found on the device, wipe
off with a soft dry cloth.
3. DO NOT leave the vision screener in excessive heat, such as in a car or in direct sunlight. High
temperatures can cause the device to malfunction.
4. The vision screener contains precision electronic circuitry. Never attempt to disassemble the vision
screener; this may result in bodily harm and will void any warranty.
5. DO NOT use cleaners that contain organic solvents to clean the vision screener’s body or the front glass.
Instead, use the provided cleaning cloth and for stubborn stains use with a small amount of water or a
non-abrasive cleaner. Always keep the front glass free of fingerprints, dirt and dust.
6. When plugging the AC power connector into The vision screener, DO NOT force the power connector into
the device as this may cause damage and will not be covered under warranty.
7. DO NOT store the vision screener in its case with the power cord plugged in, this could cause damage to
both the power cord and the device. If plugged in, store in a location with no interference with the
power cord.
8. DO NOT use the wrist strap as a means to carry the device; it is not designed to carry the weight of the
vision screener.
9. DO NOT push or scratch the touchscreen display surface with anything stiff or rigid. A stylist is
acceptable for use with the device.
10. DO NOT spill liquids on the vision screener. Please wipe off drops of liquid like saliva and water on LCD
panel surface immediately.
Warnings
1. Changes or modifications not expressly approved by Welch Allyn could void the user’s authority to
operate the equipment.
2. The supplied AC cord set should be used exclusively. Replacement or substitution may only be done with a
CSA or UL approved hospital-grade AC cord set.
3. The supplied power supply/charger may not be substituted and shall only be replaced by an approved
unit supplied by Welch Allyn.
4. Interconnection of this medical device with other medical devices, medical systems or non-medical
devices shall be evaluated to the requirements of CSA/IEC 60601-1 in the end use application.
5. This equipment is ESD sensitive; do not touch connector pins during use.
6. If the power cord or external power supply becomes damaged or its integrity is suspect, or the building
power receptacle outlet is ungrounded, then the vision screener shall only be used with the internal
battery power until replacement parts become available.
7. The operator shall not touch accessible conductive parts (ac/dc adaptor output connector, power input
connector and USB port) and the subject simultaneously.
P/N 20146 Rev A Page 5
Figure 4
Screening Environment
For optimal screening results, screen in an environment with lower level subdued lighting. Be sure
to eliminate or block any sources of sunlight and/or incandescent light from reflecting on the
subject’s eyes (See Figure 4). Florescent light is acceptable but note that the subject’s pupil size can
be affected and can decrease your chances of a successful screening.
NOTE: A minimum pupil size of 4mm is required for screening to occur and may be difficult to
achieve in a room with any light source. If the pupils are too small, the vision screener will notify
you on screen to adjust the lighting in the room. For best results, subject’s pupils should be
5mm or greater.
Getting Started
Charging
1. Connect provided AC cord set and power supply/charger together.
2. Gently lift the back of the vision screener to view the available connections.
3. Locate the DC power connector on the vision screener and connect the power
supply/charger (see Figure 5). The DC power connector on the power supply/charger will easily
insert into the DC power connector on the vision screener. Using force to connect the power
charger can damage the device and will void the warranty.
4. Plug the AC power cord into an available AC wall outlet to charge the device.
P/N 20146 Rev A Page 6
Figure 5
Powering the vision screener On and
Off
1. To turn the vision screener on, press and
release the power button (start-up process
takes approximately 30 seconds). Once
powered on, you will see the Main Menu
2. To turn the device off, press and hold power
button for two seconds. A confirmation
screen will appear to confirm shut down.
Tripod Mount
The vision screener can be mounted to a standard photographic tripod. A ¼-20 threaded mount
located on the bottom of the device is available for attaching a tripod.
Helpful Hints
•No activity on the vision screener—After 60 seconds the screen will dim; after 5 minutes the
screen will automatically turn black to conserve battery power. Tap the screen to ‘wake up’ the
vision screener or press the power button. If the screen does not light up, plug in the power
cord and try again.
•Exporting/Delete Historical Records—Verify you have successfully exported desired data to a
USB drive before you select “Delete All Records”.
•Routinely Delete ALL Records from the vision screener—Go to the History screen and select
Clear All icon. Select “Delete All Records”. You may also delete all Queued records.
•Avoid Powering Off during a Screening—Once the screening takes place, exit by selecting the
button, then power down the device normally.
•Input Screen—Holding down the button on any input (keyboard) screen will delete all
data from the field.
•Low Battery—When the battery level reaches a very low level, a notice will appear to the User
indicating they should insert the power cable or the device will shut down. If no power cable is
inserted, the device will automatically shut down due to low voltage of the battery.
P/N 20146 Rev A Page 7
Figure 6
User Operation
Main Menu – Home Screen
When the vision screener is powered on, the main menu or “Home Screen” will appear (Figure 6). If
the vision screener is connected to a network, the network name and IP address will be visible in the
upper left corner in the black bar.
Start: To begin the data entry and screening process, select the Start button, this will allow you to:
• Enter subject information such as ID, First and Last Name, Gender and DOB/Age (Required)
• Find queued subjects (exact match on the ID screen)
• Begin the screening process (Binocular and Monocular available)
• Review and print screening results
OR
Select an Age Range: To begin instant screening, with no personal subject data, select an age
range of the subject from the Home screen. You will be able to enter subject data after the
screening if desired.
Icons on bottom of screen:
• Queue – View, select or search for queued subjects from a list to begin the screening process.
• History – View already screened subjects (completed records).
• Tools – A variety of options to customize the vision screener.
Subject Information Screen
On the subject information screen (Figure 7), confirm all data is correct. You can modify information
by touching the field you wish to change. After the change is completed select “ok” and you will
come back to the subject information screen. DOB/Age is required and will highlight in red if there
P/N 20146 Rev A Page 8
Figure 7
is no age or if it is not a valid birthdate or age (under 6 months). Select GO to begin the screening
process.
Screening a Subject
1. Position yourself approximately 1 meter from the subject, as shown in Figure 8.
• If using a tripod, place the tripod approximately 1 meter from subject.
2. Start screening and slowly rotate the device upward to meet both of the subject’s eyes. Adjust
your distance from the subject until both eyes are clear on the screen.
• With a tripod, adjust the tripods position up or down and side to side until the subjects
eyes are in focus on the screen.
NOTE: Keeping the vision screener even (on axis) with the subject’s eyes will promote quicker
results and help ensure you are not capturing other objects.
3. A blue screen indicates you are too close or too far from the subject.
4. Position yourself with one foot in front of the other, slowly rock forward and back until the screen
turns grey, indicating you are in the capture range.
• When using a tripod, move the tripod as needed to ensure focus on the subject’s
pupils until the screen turns grey.
5. Keep the vision screener device steady until the screening wheel appears, indicating the capture
process is underway.
6. If you were unable to capture the subject’s pupils with a successful screening, the measurement
will be stopped, at this point you can retry, flag the record, try monocular mode or return to the
“Home” screen.
7. If the pupils are too small, the device will notify you on screen to adjust the lighting in the room
to promote larger pupil size.
P/N 20146 Rev A Page 9
Figure 8
How to Focus the vision screener
Monocular Mode
In monocular mode, you will be given the option to choose which eye to screen. This should be
attempted when binocular screening does not capture the subjects’ pupils.
1. Touch the side of the screen that corresponds with the eye you would like to screen. (OD =
subjects right eye; OS = subjects left eye).
2. When complete, you can repeat the process with the other eye by choosing Monocular from the
Results Menu.
P/N 20146 Rev A Page 10
Figure 9
Figure 10
Viewing the Results
• The results screen will appear at the end of the screening process (Figure 9).
• Results that are out-of-range are indicated in red.
• All results viewing options are in the Tools menu under Results including; defaulting to a
summary screen or the detailed results screen, hiding recommendations or measurements,
cylinder convention options and raw or rounded data.
Understanding the Results
Figure 10 below outlines the results screen and what it shows you:
P/N 20146 Rev A Page 11
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