Sure Sight
Sure Sight
Sure Sight
eet Road
Skaneat
aneateles Fa
Falls
lls, NY 13153-
13153-0220
140400 Rev. A
Table of Contents
WARNINGS & SYMBOL
BOLS ................................................................
................................................................................................
.................................................................
.................................1
MISES EN GAR
GARDE ET SYMBOL
BOLES ................................................................
..................................................................................
..................................................4
..................4
TEC
TECHNICAL SPE
SPECIFICATIONS ................................................................
........................................................................................
........................................................8
........................8
SURESIGHT
GHT DISPL
SPLAY, CONTROLS, AND FEATURES ..............................................
.............................................. 11
FIRST
RST TI
TIME SET-
ET-UP................................................................
................................................................................................
........................................................................
........................................ 14
STAND ............................................................................................................................ 14
BATTERY ......................................................................................................................... 14
PLUS OR MINUS CYLINDER CONVENTION ...................................................................... 14
DIOPTER POWER RESOLUTION ....................................................................................... 15
CONTROLS................................................................
................................................................................................
........................................................................................
........................................................ 16
i
REPLACEMENT AND RECYCLING BA
BATTE
TTER
TTERY .............................................................
............................................................. 21
REPLACING THE BATTERY ............................................................................................... 21
CHARGING ...................................................................................................................... 22
RECYCLING LITHIUM ION BATTERY ................................................................................. 22
SCREE
SCREEN
EENING MODE
ODE AND SOFTWARE UPDATE
DATES
TES .....................................................
..................................................... 23
SCREENING MODE .......................................................................................................... 23
UPDATING SURESIGHT SOFTWARE ................................................................................ 23
HAN
HAND STRAP RE
REPLACEMENT ................................................................
.....................................................................................
..................................................... 24
CLEANING AN
AND STER
TERILIZATION OF THE SURESIGHT
GHT ...........................................
........................................... 24
SERVI
RVICE, CALIBRATION, AND WARRA
RRANTY INFORMATION ................................ 25
WARRANTY ..................................................................................................................... 25
SERVICE AND WARRANTY .............................................................................................. 26
SURESIGHT RECHARGEABLE BATTERY ........................................................................... 26
CALIBRATION AND MAINTENANCE ................................................................................ 26
ii
Warnings
ngs & Symbol
bols
Use only with IEC 60601-1 approved printers, or keep printer out of
patient vicinity.
1
Do not attempt to disassemble or modify the battery pack. There are no
user serviceable parts inside pack.
If electrolyte leaking from battery contacts your skin or eyes, rinse with
running water and immediately seek medical attention.
2
Type BF Equipment.
Double Insulated.
ETL listed: UL2601-1, CSA C22.2 No. 601.1, IEC 60601-1, AS 3200.1.
IEC 60601-1-2
The CE mark on this device indicates that it has been tested and
conforms to the provisions noted within the 93/42/EEC Medical Device
Directive.
3
Mises en gar
garde et sym
symbol
boles
5
Ne pas utiliser en présence d'anesthésiques inflammables.
Double isolation.
o
Homologations ETL : UL 2601-1, CSA C22.2, N 601.1 et IEC 60601-1,
AS3200.1, IEC 60601-1-2
6
Authorized European Representative Address:
European Regulatory Manager
Welch Allyn, Ltd.
Kells Road, Navan
Count Meath, Republic of Ireland
Telephone: 353-46-28122
Fax: 353-46-28536
Note: This product contains no hazardous materials. Its disposal will not
contaminate or harm the environment, or present any risk to individuals
disposing of the product. As a precaution, it is recommended you contact your
local disposal and/or recycling authority for information regarding the disposal of
the equipment.
7
Techni
echnical
cal Speci
pecificat
cations
ons
Technol
Technology
ogy: Welch Allyn proprietary autorefractor
hardware/algorithm
Working di
distance:
ance: 14 inches (35 cm.)
Distance det
detect
ection:
on: Automatic, with audible and visual cues
Eyepi
epiece:
ece: Illuminated target for easy aiming
Data acqui
acquisition time: 2.4s/eye
Data acqui
acquisition:
on: Measures and averages 5 to 8 readings/eye
Reliab
liabili
abilit
ility meas
easure: Indicates number of and variation among
measurements for the given eye
Diopt
opter display: 1/8 or 1/4 diopter increments
Axis: 1ô increments
Stand:
and: Compact charger and SureSight storage
Weight
ght: Approximately 2.0 lbs. (0.9 Kg.)
Dimens
ensions
ons: 6.5” x 7.75” x 2”
Class II equi
equipment
ent: Continuous operation.
Trans
anspor
port/S
t/Storage:
age -20°C∼49°C, 10%∼100% R.H. Max, 500hPa -
1060hPa Altitude
Oper
perating:
ng: 10°C∼30°C, 30%∼75% R.H. Max, 500hPa -
1060hPa Altitude
Meas
easurement
ent Range:
ange: Sphere: +6.0 to –5.0 Diopters
Cylinder: ± 3 Diopters
Batte
ttery vo
voltage:
age: 7.2v nominal (Lithium Ion)
Batte
ttery lif
life: More than 3 hours of continuous usage
Low-Batte
ttery warning:
ng: Indicates 10 - 15 minutes usage remains
8
Interfaces
aces: Remote infrared link to thermal printer.
RS-232 interface for IBM compatible PC for
future software upgrades/data transfer to
electronic medical records.
Laser safety: Class 1 Laser Product per CDRH 21CFR
1040.10 and 1040.11, IEC 825-1 (1996) pending
and EN60825-1 (1996) pending
Patent
ents: US and International Patents Pending
Offi
ffice illu
illuminat
nation:
on: Not for use in direct sunlight. Indoor
operation only.
Materials: This product is latex free.
Elect
ectromagnet
agnetic FCC Part 15, Class A (USA)
Compat
patibilit
ility: This device complies with CFR 47 Part 15,
Class A of the FCC Rules.
Operation is subject to the following two
conditions:
(1) This device may not cause harmful
interference and
(2) This device must accept any
interference received including
interference that may cause undesired
operation.
9
Funct
unction and Intended Appli
pplica
licat
cation
Thank you for purchasing the Welch Allyn SureSight Autorefractor. Please
read and follow the instructions found in this manual before using your new
SureSight to ensure accurate and reliable service.
SureSight is the first child-friendly, portable autorefractor that lets you test
patients − including young children and adults − anytime, anywhere. Carry it
from room to room, to your waiting area, even off-site.
SureSight solves many of the problems you face when performing exams. You
can perform objective refraction from a non-threatening 14 inches (35 cm) away
− even through glasses and contact lenses. The unit’s flashing lights and sounds
engage the patient throughout the exam. There’s no intimidating equipment. No
cycloplegic drops to contend with. Just fast, easy refractions. That’s why
SureSight makes testing even your toughest patients quick and painless − for
both you and your patients.
10
SureSight
ght Display, Cont
ontrols, and Feat
eatures
Axis
Self-adjusting hand
strap
11
Char
harging Jac
Jackk Recept
eceptacl
acle
Recept
eceptacl
acle for RS232
RS232
Batte
ttery Compar
partment
ent Connect
onnection
12
Fixation LEDs
Distance Sens
ensor
IR lin
link to pr
printer
13
First Time Set-Up
Stand
• Insert right angle connector into stand
• Optional: Two strips of hook and loop fasteners are provided on the stand.
Attach mating strips to countertop or “home” location of the stand. For best
results, clean surface and allow to dry before adhering. Hook and loop
fasteners keep stand firmly in place for use, while allowing it to be removed
as needed.
Batte
ttery
• Insert battery:
1) Open the battery cover located on the underside of the unit by sliding it in
the direction indicated by the arrow and lifting out.
2) Insert the new battery into the compartment in the direction of the arrow on
the battery itself, so that the terminal end enters the compartment first. If
necessary, rotate the lever obstructing the compartment in a clockwise
direction until the compartment is unobstructed. NOTE: TE: Insert the battery
only as directed. Failure to do so will prevent the instrument from
functioning.
3) While pushing in on the battery, rotate the lever in a counter-clockwise
direction until it covers the battery.
4) Replace the cover by lightly pushing in on the raised end until it is level and
sliding the cover in the opposite direction of the arrow until it locks into
place.
Plus or Mi
Minus
nus Cylinde
linder
nder Conv
onvent
ention
Your SureSight was set at the factory to the Minus Cylinder Convention. If you
wish to change your unit to the plus convention:
1) Open the battery cover located on the underside of the unit by sliding it in
the direction indicated by the arrow and lift up.
2) Rotate the lever holding the battery in and lift the battery from its
compartment.
3) View the DIP switches inside the battery compartment located on the button
side of the unit.
4) Using tweezers or another appropriate tool, pull the first switch (located on
the side of the unit with the handstrap) up towards the bottom of the
SureSight.
14
Diopt
opter Power Resolution
Your SureSight was set at the factory to display power in 1/4 diopter increments.
If you wish to change to 1/8 diopter increments:
1) Open the battery cover located on the underside of the unit by sliding it in
the direction indicated by the arrow and lift up.
2) Rotate the lever holding the battery in and lift the battery from its
compartment.
3) View the DIP switches inside the battery compartment located on the button
side of the unit.
4) Using tweezers or another appropriate tool, pull the third switch (third from
side of SureSight with the handstrap) up towards the bottom of the
SureSight.
15
Cont
ontrols
The buttons on the back of the instrument function as follows:
Child
ild/Adul
dult Calib
libration Left/R
ft/Right
ght Toggl
Toggle & Print
• Clears readings • Selects single eye to re-
• Changes child/adult test or switches back to
Calibration by holding it regular test.
down • Prints results (hold button
down while aiming patient
side of SureSight at
printer until you hear “tah-
dah”)
“GO”
GO” Button
tton
• Unit on:
on: starts test
• Unit off:
ff: recalls old
readings (if fewer than 5
minutes have passed)
The instrument will go into sleep mode after being unused for 2 1/2 minutes. Any
button pressed on the SureSight will bring up results during sleep for 2 1/2
minutes.
16
Oper
perating Instruct
uctions
ons
• Push any button to turn on the unit.
• Position the patient so that eye levels can be adjusted for unit use.
• Press the child/adult button until you hear a beep to choose the appropriate
calibration. (Child/Adult Calibration cut over age is 10 – see Adult/Child
Calibration Section, page 21 for more information).
• Explain the test procedure to the patient:
“Now I will check your eyes. (Or “Now I’m going to take movies of you.”)
“I want you to look for the red light in the middle of the blinking green lights.”
• Position yourself at eye-level and square with the face of the patient.
• Push the “GO” button on the unit and check that the patient is fixated
correctly during the test.
• Position the unit at the correct distance from the patient:
• When too far away, you will hear slow, low-pitched beeps.• • • • • •
• Slowly move closer. When the unit is at the correct distance (∼14”), you
will hear a steady, low tone.
• When the unit is too close, you will hear quick, high-pitched beeps. xxxxxx
• The cross hairs will flash in synch with the tones.
• When you are at the correct distance, look through the peephole and align
the cross hairs on the pupil of the patient’s right eye. While the unit is
acquiring data, you will hear a very high-pitched chirping sound with a
steady low tone. ° ° ° °
• When the test of the right eye is complete, you will hear the “tah-dah”
sound.
• Rotate the unit to the left eye and align the cross hair over the left eye’s pupil
and repeat. (Testing resumes 1 second after the first eye is complete, so you
do not need to press any buttons.)
• At the end of the test, you will hear the “tah-dah” sound again.
• If the unit has not gathered enough good readings from either eye, you will
hear 5 tones to signify that the testing has stopped. - - - - - You must re-test
that eye.
• If you are at the correct distance and not acquiring data:
• ensure you are level and square with the patient,
• tell the patient to look into the red light,
• slowly move the cross-hairs around the eye, and
• make sure the patient’s eyelids are not occluding the pupil
• aim higher when over-refracting through glasses
17
• To stop a test at any time, hold any button until 5 tones sound.
• When in the sleep mode, any button wakes the unit and displays the
previous results.
• To Print: Press the print button until beep sounds. Keep unit aimed at printer
during beep.
• Do not send 2 printout to printer before 1 printout has completed
nd st
printing
18
Impor
portant
ant Oper
perating Ti
Tips
To insure accurate results and quick tests:
• Ambient
ent Light
ghting:
ng:
- Don’t perform by uncovered windows
- Dimmed light can help for adults w/small pupils
• Too dim can make it harder to find the pupil for those with dark
eyes.
• Ent
Entry Angl
ngle
- Position unit straight and level with patient
- Rotate unit to test left eye
• Fixation:
on: “Loo
“Look
ook at the
the red ligh
light
ght”
- Remind patient and monitor fixation
• Correc
rrect
ect Distance/
ance/Not Tak
Taking Readi
eadings?
ngs?
- Are you square and level?
- Scan around the pupil
- Ask patient if they see the red light
- When over-refracting through glasses, aim higher
19
Reliability Number
Sphere
Axis
Cylinder
Child/Adult Mode
Results
Reliab
liabili
abilit
ility Number
ber indicates the number of good readings obtained and their
consistency, based on a 1 to 9 scale. The higher the number, the better.
• ≥6 is typically acceptable✩
• 5 is marginal / repeat the test if possible
• ≤4 is poor / repetition of the test is necessary
✩
If the patient did not appear to fixate on the unit during data acquisition,
repeat the test, even if reliability numbers are ≥6.
• S is the spher
phere in diopters.
• C is the cylinde
linder
nder power in diopters.
• The SW X.XXe after the date on the printout is the software revision level in
the SureSight unit.
20
Adul
dult/C
t/Child
ild Calib
libration
The adult/child calibration makes three basic changes to the way the unit
operates.
• Corrects distance target to match the “size” of the face being tested.
• Selects the proper default accommodation setting.
• Activates the screening referral indicators (in screening mode only).
Adul
dult/C
t/Child
ild Mode Ti
Tips
• If a child is myopic, use the adult mode to get the best estimate of
refraction. The child mode infers accommodation based on a typical
three-year-old hyperope.
• If you are using cycloplegia, always use the adult mode to get the best
estimate of refraction.
Repl
eplacem
acement
ent and Recy
ecycling
ling of
of Batte
ttery
Repl
eplaci
acing the Batte
ttery
1) Open the battery cover located on the underside of the unit by sliding it in
the direction indicated by the arrow and lifting out.
2) Rotate the lever holding the battery in clockwise direction until the battery is
unobstructed.
3) Carefully tip the unit to allow the battery to slide out of the compartment.
4) Insert the new battery into the compartment in the direction of the arrow on
the battery itself, so that the terminal end enters the compartment first.
NOTE: Insert the battery only as directed. Failure to do so will prevent the
instrument from functioning.
5) While pushing in on the battery, rotate the lever in a counter-clockwise
direction until it covers the battery.
6) Replace the cover by lightly pushing in on the raised end until it is level and
sliding the cover in the opposite direction of the arrow until it locks into
place.
21
Char
harging
• A charged unit can test patients for approximately 3 continuous hours.
• With ∼10 -15 minutes of on time remaining, the low-battery indicator will
begin to flash on the display. When low-battery indicator is steady, battery
must be recharged.
• To charge, place the unit completely and firmly into the stand. Unit
automatically controls charge into battery when used with Welch Allyn
approved 710 series chargers (Instrument will fit into the stand only one
way).
• Unit will turn off when charging.
• To prolong on-time, press three buttons simultaneously to shut down
(readings will be deleted).
Recy
ecycling
ling Lithium Ion Batte
ttery
Welch Allyn now employs the services of an agency which can disassemble and
recycle all components of rechargeable batteries so that nothing gets landfilled
or incinerated. Should you wish to dispose of your expended Welch Allyn
rechargeable battery via recycling (in the U.S. and Canada only), please send to:
For locations outside the U.S. and Canada consult your local recycling authority
for correct disposal of batteries.
22
Screeni
eening Mode and Softw
ftware Updat
pdates
Screeni
eening Mode
SureSight has an available screening mode to facilitate screening refraction by
non-specialists. In this mode:
• No axis is displayed
• Power readings are displayed to 1 decimal place only
• In child mode:
• Refractive difference D the difference in mean spherical power
between the two eyes is displayed.
• *An asterisk on a reading in child mode indicates it is in AAO pre-school
referral range.
To place your SureSight in screening mode:
1) Open the battery cover located on the underside of the unit by sliding it in
the direction indicated by the arrow and lift up.
2) Rotate the lever holding the battery in and lift the battery from its
compartment.
3) View the DIP switches inside the battery compartment located on the button
side of the unit.
Using tweezers or another appropriate tool, pull the second switch (starting with
the side of the unit with the handstrap) up towards the bottom of the SureSight.
Updat
pdating SureSight
ght Softw
ftware
If it is necessary or desired to update the unit software:
1) Connect the 9-pin female side of the cable supplied with the software disk to
a PC (IBM compatible, 486 processor, Windows 3.1 or higher) COM1 or
COM2 RS 232 port.
2) Connect the modular jack end of the cable to the RS232 port on the bottom
of the SureSight (when SureSight is powered down).
3) Insert floppy disk into PC’s 3.5” floppy disk drive.
4) Run a:\setup to begin update.
5) Follow the prompts displayed on the PC.
23
Hand Strap Repl
eplacem
acement
ent
1) Position the unit so that the hand strap is facing up and the battery door
compartment is toward you.
2) Push the hand strap forward until the square notches beneath it are visible;
hold the strap in this position with one hand.
3) Insert the tool provided into one of the notches and press outward until the
fastener is released.
4) Repeat step 3 on the other fastener.
5) Insert the fasteners of the new strap into the appropriate slots, so that
“Welch Allyn” can be read.
6) Finally, pull on the strap to ensure that it is seated properly.
Cleani
eaning and Steriliz
ilization of
of the
the SureSight
ght
NOTE: Excess solution entering the assembly could damage internal
components. Use caution to ensure cloth is not saturated with solution.
Cleaning solutions should be sprayed on the soft cloth rather than
directly on the SureSight device.
All windows on the SureSight can be cleaned with a soft cloth moistened with
70% Isopropyl Alcohol or any standard window cleaner.
The remaining housings, softgrip, handstrap and stand may be cleaned with
either a dry, soft cloth or a soft cloth moistened with any of the following: 10%
Clorox solution, soapy water, 70% Isopropyl Alcohol, alcohol pads, standard
window cleaner.
24
Service,
ce, Calib
libration,
on, and Warran
rrant
anty Information
The serial number is located on a label inside the battery door.
Warran
rrant
anty
SureSightght In
Instrument
ent
Welch Allyn, Inc. warrants the SureSight instrument to be free of original
defects in material and workmanship and to perform in accordance with
manufacturer’s specifications for a period of one year from the date of purchase.
If this instrument or any other component thereof is found to be defective or at
variance from the manufacturer’s specifications during the warranty period,
Welch Allyn will repair, replace, or recalibrate the instrument or component(s) at
no cost to the purchaser.
This warranty only applies to instruments purchased new from Welch Allyn or its
authorized distributors or representatives. The purchaser must return the
instrument directly to Welch Allyn or an authorized SureSight distributor or
representative and bear the cost of shipping.
This warranty does not cover breakage or failure due to tampering, misuse,
neglect, accidents, modification or shipping, and is void if the instrument is not
used in accordance with manufacturer’s recommendations or if repaired or
serviced by other than Welch Allyn or a Welch Allyn authorized representative.
25
Service and Warran
rrant
anty
For customers in North America, please return instruments requiring service to
Welch Allyn Technical Service Department listed below or to an authorized
Welch Allyn Technical Service Department.
In Canada:
Telephone: 1-800-561-8797
Fax: 1-905-890-0008
SureSight
ght Rechar
echargeabl
geable Batte
ttery
Welch Allyn Lithium Ion batteries are warranted by Welch Allyn for two years
from date of manufacture (when used in Welch Allyn instruments only).
Defective batteries will be replaced on a pro rata basis should failure occur prior
to expiration date on battery.
Calib
libration and Maintenance
When the calibration symbol is shown, it indicates that it has been 12
months since the unit was last calibrated. It is recommended that you
send the unit in for re-calibration.
26