Welch Allyn Spot Vision Screener VS100 Manual

Welch Allyn® Spot™ Vision
Screener Model VS100
Directions for use
Software version 3.1.XX

© 2018 Welch Allyn, Inc. All rights are reserved. To support the intended use of the product described in
this publication, the purchaser of the product is permitted to copy this publication, for internal distribution
only, from the media provided by Welch Allyn. No other use, reproduction, or distribution of this
publication, or any part of it, is permitted without written permission from Welch Allyn.
Welch Allyn assumes no responsibility for any injury, or for any illegal or improper use of the product, that
may result from failure to use this product in accordance with the instructions, cautions, warnings, or
indications for use published in this manual.
Welch Allyn®is a registered trademark of Welch Allyn, Inc.
Spot is trademark of Welch Allyn.
Software in this product is copyright Welch Allyn or its vendors. All rights are reserved. The software is
protected by United States of America copyright laws and international treaty provisions applicable
worldwide. Under such laws, the licensee is entitled to use the copy of the software incorporated within
this instrument as intended in the operation of the product in which it is embedded. The software may
not be copied, decompiled, reverse-engineered, disassembled or otherwise reduced to human-
perceivable form. This is not a sale of the software or any copy of the software; all right, title and
ownership of the software remains with Welch Allyn or its vendors.
This product may contain "free" or "open source" software (FOSS). To learn more about Welch Allyn's use
and support of FOSS, please visit http://www.welchallyn.com/opensource.
For patent information, please visit www.welchallyn.com/patents.
For information about any Welch Allyn product, contact Welch Allyn Technical Support:
www.welchallyn.com/about/company/locations.htm.
DIR 80024081 Ver. A
Revision date: 2018-11 This manual applies to the 901029 Vision Screener.
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 U.S.A
www.welchallyn.com
Regulatory Affairs Representative
Welch Allyn Limited
Navan Business Park
Dublin Road
Navan, County Meath
Republic of Ireland

Contents
Introduction ............................................................................................. 1
About this document ........................................................................................... 1
Intended use ........................................................................................................ 1
Indications for use ................................................................................................ 1
Contraindications ................................................................................................. 1
Symbols ............................................................................................................... 2
Warnings, cautions and notes .............................................................................. 5
Controls, Display Window, and Connections ....................................... 7
Features ............................................................................................................... 7
Display Window ................................................................................................... 9
Tools .................................................................................................................. 10
Setting up the vision screener ............................................................. 13
Contents Checklist ............................................................................................. 13
To charge the vision screener ............................................................................ 13
To turn on the vision screener ........................................................................... 14
To set the language ........................................................................................... 15
To set the system clock ..................................................................................... 15
Screening subjects ................................................................................ 17
Before screening a subject ................................................................................ 17
Subject Information screen ................................................................................ 18
To screen a subject ............................................................................................ 18
The Subject Results screen ............................................................................... 21
To screen in monocular mode ........................................................................... 22
Overview: Conducting a mass screening .......................................................... 22
To delete records ............................................................................................... 23
Advanced settings on the vision screener .......................................... 25
Before configuring network security .................................................................. 25
Connecting a device to the network .................................................................. 26
Printing ............................................................................................................... 27
About importing and exporting .......................................................................... 30
Custom banner .................................................................................................. 33
Web access ....................................................................................................... 34
Vision screener criteria ....................................................................................... 34
About licensing .................................................................................................. 35
To enable/disable security on the vision screener ............................................. 35
To lock/unlock the vision screener ..................................................................... 36
To check the storage capacity ........................................................................... 36
iii

Maintenance and cleaning ................................................................... 37
Cleaning the vision screener .............................................................................. 37
Storing the equipment ....................................................................................... 38
Disposing of electronic equipment .................................................................... 38
Troubleshooting .................................................................................... 39
System restart ................................................................................................... 39
System freeze .................................................................................................... 39
Screening Issues ................................................................................................ 39
Printer issues ..................................................................................................... 41
Wireless issues .................................................................................................. 41
Battery Issues .................................................................................................... 41
Import/Export Issues .......................................................................................... 42
Restoring and restarting system messages ...................................................... 43
Specifications ........................................................................................ 45
EMC information ................................................................................................ 47
EMC table .......................................................................................................... 48
Service policy ........................................................................................ 55
Warranty ................................................................................................ 57
Configuration options for the VS100 vision screener ........................ 59
Approved accessories ........................................................................... 61
Tripod mount ......................................................................................... 63
iv Contents Welch Allyn® Spot™ Vision Screener Model VS100

Introduction
About this document
This Directions for use manual is a comprehensive guide designed to help you
understand the capabilities and operation of your Spot Vision Screener VS100. The
information in this manual includes all options available with the Spot Vision Screener.
The applicability of some sections of this manual depends on the configuration of your
particular device. Read this manual thoroughly before attempting to use the device.
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. 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 screening provides simultaneous binocular assessment of the subject’s refraction,
pupil size and gaze.
Intended use
The Spot Vision Screener is intended to produce optical images that can help identify
refractive errors and ocular misalignments by detecting special light reflexes from each
eye during screening. The Spot Vision Screener evaluates these light reflexes from the
retina to estimate refractive error. 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 Spot 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. This type of photoretinoscopy device is
intended to help the healthcare professional assess whether the subject should be
referred to an eye care specialist for further evaluation or simply be monitored at future
screenings. This screening is not intended to replace a full eye examination.
Contraindications
The Spot Vision Screener has no known contraindications.
1

Symbols
For information on the origin of these symbols, visit http://www.welchallyn.com/
symbolsglossary for the Welch Allyn symbols glossary.
Documentation symbols
Consult directions for use (DFU). A copy
of the DFU is available on this website. A
printed copy of the DFU can be ordered
from Welch Allyn for delivery within 7
calendar days.
WARNING The warning statements in
this manual identify conditions or
practices that could lead to illness, injury,
or death.
Caution The caution statements in this
manual identify conditions or practices
that could result in damage to the
equipment or other property, or loss of
data. This definition applies to both
yellow and black and white symbols.
Power symbols
Rated power input, DC Rechargeable battery
Power on/off USB
DC power input port, Center pin positive
Miscellaneous symbols
IPXO Not protected against the ingress of
water. Non-ionizing electromagnetic radiation
Manufacturer Reorder Number
Product Identifier Serial Number
Authorized Representative in the
European Community Global Trade Item Number
2Introduction Welch Allyn® Spot™ Vision Screener Model VS100

Meets essential requirements of the
European Medical Device Directive 93/
42/EC
User Interface Symbols
Battery
status/level
indicator
Battery charging
Wireless
On/Off
button
Connected to the wireless network
No wireless
network in
range
No IP address assigned by the router
Unknown
network Cannot connect to configured network
Sound off Sound on
Continue Back
Exit Print job in progress
Shipping, storing, and environment symbols
This way up Keep Dry
Fragile Humidity limitation
Directions for use Introduction 3

Temperature limit Atmospheric pressure limitation
Separate collection of batteries. Do not
dispose as unsorted municipal waste. Recyclable
Separate collection of Electrical and
Electronic Equipment. Do not dispose as
unsorted municipal waste.
Keep away from sunlight
Lithium ion battery
4Introduction Welch Allyn® Spot™ Vision Screener Model VS100

Warnings, cautions and notes
WARNING Risk of electric shock. All signal input and output (SIP/SOP)
connectors are intended for connection of only other medical devices,
medical systems or non-medical devices complying with IEC 60601-1, or
other IEC standards appropriate to the device. For example, a printer
connected via USB must comply with IEC 60950. Connecting additional
unapproved devices to the device might increase chassis or subject
leakage currents.
WARNING Risk of electric shock. No modification of this equipment is
allowed.
WARNING Risk of electric shock. Do not open the device or attempt
repairs. The device has no user-serviceable internal parts. Only perform
routine cleaning and maintenance procedures specifically described in this
manual. Inspection and servicing of internal parts shall only be performed
by qualified service personnel. Attempt to modify this device may result in
bodily harm and will void product warranty.
WARNING Risk of electric shock. Do not allow the subject to make
contact with accessible conductive parts (DC adaptor output connector,
power input connector and USB port). Additionally, you should not make
contact with the subject and any accessible conductive parts at the same
time.
WARNING To avoid a possible explosion, do not use the device in the
presence of flammable anesthetics: mixtures containing air, oxygen, or
nitrous oxide.
WARNING Risk of data loss. If a reboot is required during a system freeze,
data loss, such as printer configuration and subject data, can occur.
WARNING Lithium ion battery. Risk of fire, explosion, and burns. Do not
handle or disassemble the battery pack.
WARNING Use only accessories approved by Welch Allyn. Visit
www.welchallyn.com. The use of any other accessories can result in
inaccurate subject data, can damage the equipment, and can void your
product warranty.
WARNING Injury risk and equipment damage risk. When charging the
device, properly secure all DC transformer cords to minimize trip hazards.
WARNING subject injury risk. Verify subject identity on the device after
manual entry and before printing or transferring subject records.
WARNING False positive and false negative results may occur in a
healthcare screening. Vision screening does not replace a complete eye
examination by an ophthalmologist or optometrist.
WARNING The use of screening results for recommending therapy is
reserved exclusively for eye care professionals.
WARNING The screening results may not be used directly for the
prescription of corrective eyewear.
Directions for use Introduction 5

CAUTION The device contains high-quality, fragile parts. Do not subject it
to physical shock.
CAUTION Do not use the wrist strap as a means to carry the device; it is
not designed to carry the weight of the device.
CAUTION The device is not waterproof. If you accidentally drop it into
liquid or liquid is spilled on the device, contact Welch Allyn Technical
Support immediately. If minor water droplets are found on the device, wipe
off with a soft dry cloth.
CAUTION Do not store the device in the foam or case while the DC power
adapter is plugged in; this may cause damage to the power cord and to the
device.
CAUTION Do not leave the device in excessive heat or in direct sunlight.
High temperatures can cause the device to malfunction.
CAUTION When plugging the DC power connector into the device, do not
force the power connector into the device; this may cause damage to the
device, which will not be covered under warranty.
CAUTION Do not push or scratch the touchscreen display with stiff or
rigid objects. This may cause damage to the device. A stylus is acceptable
for use with the device.
Note 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.
Note The power cord set may not be used with any other equipment other than
the Welch Allyn Spot Vision Screener VS100.
6Introduction Welch Allyn® Spot™ Vision Screener Model VS100