4341 State Street Road
Skaneateles Falls, NY 13153-0220
0297
718445 Rev. A
Table of Contents
Warnings & Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Mises en garde et symboles . . . . . . . . . . . . . . . . . . . . . . . . 4
Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Function and Intended Application . . . . . . . . . . . . . . . . . . 10
SureSight Display, Controls, and Features . . . . . . . . . . . . 11
First Time Set-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Plus or Minus Cylinder Convention . . . . . . . . . . . . . . . . . . . . . 14
Diopter Power Resolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Important Operating Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Helpful hints for testing pre-schoolers . . . . . . . . . . . . . . . . . . . 18
Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Adult/Child Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Adult/Child Mode Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Replacement and Recycling of Battery . . . . . . . . . . . . . . . 20
Replacing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Recycling Lithium Ion Battery . . . . . . . . . . . . . . . . . . . . . . . . . 21
Screening Mode and Software Updates . . . . . . . . . . . . . . 22
Screening Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Updating SureSight Software . . . . . . . . . . . . . . . . . . . . . . . . . 22
Hand Strap Replacement . . . . . . . . . . . . . . . . . . . . . . . . . 23
Cleaning and Sterilization of the SureSight . . . . . . . . . . . . 23
Service, Calibration, and Warranty Information . . . . . . . . . 24
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Service and Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
SureSight Rechargeable Battery . . . . . . . . . . . . . . . . . . . . . . . 25
Calibration and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Guidance and Manufacturer’s Declarations . . . . . . . . . . . 26
Emissions and Immunity Information . . . . . . . . . . . . . . . . . . . 26
Warnings & Symbols
ATTENTION: Refer to the operating instructions. This symbol ( ) is
intended to advise the user of the presence of important operating or
maintenance instructions in the documents accompanying the instrument.
WARNING: Do not modify this equipment. Any modification of this
equipment can lead to patient injury. Any modification of this equipment voids the product warranty.
Service or Repair to be performed by qualified, authorized personnel
only. There are no user serviceable parts inside the instrument.
Opening this device can expose the user to harmful invisible laser
radiation.
Use only with Welch Allyn 710 series chargers.
Replacement parts and accessories - Use only approved replacement
parts and accessories specified in this manual. Refer to the maintenance section of this manual for more information.
Do not sterilize the instrument or any of its components.
Use only with IEC 60601-1 approved printers, or keep printer out of
patient vicinity.
Disassembly of instrument beyond the extent described in this manual will void the warranty. Refer all servicing to Welch Allyn or a
Welch Allyn authorized service representative listed in the Servicing,
Calibration and Warranty Information section. Opening this device
can expose the user to harmful invisible laser radiation. Only the battery cover is to be opened by the user.
1
As a precaution, avoid using this product in close proximity to other
equipment. The product complies with current required standards for
electromagnetic interference and should not present problems to
other equipment or be affected by other devices.
Battery replacement: Replace with Welch Allyn model # 72420 Lithium Ion battery only.
Do not attempt to disassemble or modify the battery pack. There are
no user serviceable parts inside pack.
Do not attempt to directly solder to the battery pack.
Do not attempt to connect the positive and negative battery terminals to each other, nor to any other device.
“Caution” - use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.
Product contains two internal apertures within the laser tube assembly. These are not user replaceable or user adjustable. DO NOT
attempt to make any aperture adjustments to this product.
Do not operate, charge, leave or discard battery pack in any environment where it may exceed 0°C to 40°C.
Do not immerse the battery pack in water.
Do not attempt to open or pierce the battery pack.
Do not strike or throw the battery pack.
2
Do not use a battery pack which appears to be deformed, leaking,
Welch Allyn PTY, Ltd - Australia
Metro Centre
Unit 5/38 South Street
Rydalmere NSW 2116, Australia
0297
corroded, or is otherwise irregular.
If electrolyte leaking from battery contacts your skin or eyes, rinse
with running water and immediately seek medical attention.
If the device will be unused for several months or longer, remove the
battery prior to storing the device.
IPXØ: Not protected against the ingress of water.
Not for use in the presence of flammable anesthetics.
Double Insulated.
Australia EMC Framework Compliance
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 garde et symboles
ATTENTION : Consulter le mode d'emploi. Ce symbole ( ) signale
à l’utilisateur la présence de renseignements importants relatifs au
fonctionnement ou à l'entretien de l'instrument dans les documents
qui l'accompagnent.
AVERTISSEMENT : Ne modifiez pas l’équipement. Toute modification de l’équipement peut être source de blessures au patient. Toute
modification de l’équipement annule la garantie produit.
L'entretien ou la réparation ne doivent être effectués que par un personnel compétent habilité. Cet instrument ne contient pas de pièces
réparables par l'utilisateur. L'ouverture de ce dispositif risque
d'exposer l'utilisateur à un rayonnement laser invisible nocif.
Utiliser uniquement avec des chargeurs Welch Allyn série 710.
Pièces et accessoires de rechange – Utiliser uniquement les pièces
et accessoires de rechange autorisés spécifiés dans ce manuel. Consulter la section Entretien de ce manuel pour des informations supplémentaires.
Ne pas stériliser l'instrument ni aucun de ses composants.
Utiliser uniquement avec une imprimante conforme à la norme CEI
60601-1, ou utiliser l'imprimante à distance du patient.
Un démontage de l'instrument au-delà des recommandations de ce
manuel annule la garantie. Confier toutes réparations à Welch Allyn
ou à un représentant agréé par Welch Allyn listé dans la section Informations sur les réparations, l'étalonnage et la garantie. L'ouverture
de ce dispositif risque d'exposer l'utilisateur à un rayonnement laser
invisible nocif. Seul le couvercle de la batterie peut être ouvert par
l'utilisateur.
4
Avertissement : À titre de précaution, éviter d’utiliser le produit en
proximité étroite avec d’autres appareils. Le produit est conforme
aux normes actuelles en matière d’interférences électromagnétiques
et ne devrait pas causer de problème à d’autres appareils ni être
affecté par leur fonctionnement.
Remplacement de la batterie : Remplacer uniquement par une batte-
o
rie au lithium Welch Allyn modèle n
72420.
Ne pas essayer de démonter ou de modifier le bloc-batterie. Il ne
contient pas de pièces réparables par l'utilisateur.
Ne pas essayer de souder directement sur le bloc-batterie.
Ne pas essayer de relier les bornes positive et négative l'une à
l'autre, ou à d'autres dispositifs.
Attention : Des procédures de contrôle, de réglage ou de performance autres que celles qui sont spécifiées dans cette notice peuvent entraîner une exposition dangereuse au rayonnement.
Le produit comprend deux ouvertures internes à l'intérieur du tube
laser. L'utilisateur ne doit ni les ajuster, ni les remplacer. NE JAMAIS
essayer d'ajuster une ouverture sur ce produit.
Ne pas activer, charger, laisser ou jeter le bloc-batterie à un endroit où
°
la température ambiante est inférieure à 0° C ou supérieure à 40
C.
Ne pas immerger le bloc-batterie dans l'eau.
Ne pas essayer d'ouvrir ou de percer le bloc-batterie.
Ne pas frapper ni lancer le bloc-batterie.
5
Ne pas utiliser un bloc-batterie qui semble fuir ou être déformé,
0297
corrodé ou anormal.
En cas de contact cutané ou oculaire avec une fuite d'électrolytes de
la batterie, rincer à l'eau courante et consulter immédiatement un
médecin.
Si l’opérateur prévoit de ne pas utiliser l’appareil pendant plusieurs
mois, voire plus, retirer la batterie avant de stocker l’appareil.
IPXØ : Non protégé contre l’infiltration d'eau.
Ne pas utiliser en présence d'anesthésiques inflammables.
Double isolation.
Welch Allyn PTY, Ltd - Australia
Metro Centre
Unit 5/38 South Street
Rydalmere NSW 2116, Australia
Obedece la norma australiana EMC Framework
La marque CE appliquée sur ce dispositif indique qu'il a été testé et
déclaré conforme aux dispositions de la directive 93/42 de la CEE
sur les appareils médicaux.
Authorized European Representative Address:
Regulatory Affairs Representative
Welch Allyn, Limited
Navan Business Park
Dublin Road
Navan, County Meath, Republic of Ireland
6
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
Technical Specifications
Technology: Welch Allyn proprietary autorefractor hardware/
algorithm
Working distance: 14 inches (35 cm.)
Distance detection: Automatic, with audible and visual cues
Eyepiece: Illuminated target for easy aiming
Data acquisition time: 2.4s/eye
Data acquisition: Measures and averages 5 to 8 readings/eye
Measurement Range: Sphere: +5.5 to -5.0 Diopters
Cylinder: +/- 3 Diopters
Reliability measure: Indicates number of and variation among
measurements for the given eye
Diopter display: 1/8 or 1/4 diopter increments
Axis: 1° increments
Stand: Compact charger and SureSight storage
Weight: Approximately 2.0 lbs. (0.9 Kg.)
Dimensions: 6.5” x 7.75” x 2”
Interfaces: 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 60825-1:2001
The maximum output of the laser radiation not to
exceed 33 W at a wavelength of 785 nm.
8
Patents: US 6,007,204 and Des. 413,979 International Patents
Pending
Office illumination: Not for use in direct sunlight. Indoor operation only.
Materials: This product is latex free.
Safety, EMC, and CAN/CSA C22.2 No. 601.1
Regulatory Compliance: CAN/CSA C22.2 No. 601.1.2
CAN/CSA C22.2 No. 601.1.4
IEC/EN 60601-1
IEC/EN 60601-1-2
IEC/EN 60601-1-4
ANSI/AAMI ES60601-1
Environmental Specifications
Transport/Storage: -20°C~49°C, 10%(100% R.H. Max, 500hPa -
1060hPa Altitude
Operating: 10°C~30°C, 30%(75% R.H. Max, 500hPa - 1060hPa
Altitude
Battery Specifications
Battery voltage: 7.2v nominal (Lithium Ion)
Battery life: More than 3 hours of continuous usage
Low-Battery warning: Indicates 10 - 15 minutes usage remains
Classifications
Protection against electric shock: Class II equipment and internally powered.
Mode of operation: Continuous use
Method of sterilization: Refer to Cleaning and Sterilization of the SureSight
9
Function and Intended Application
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 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 Display, Controls, and Features
“Right” eye field
Sphere
Cylinder
Axis
Clear results
and Child/adult
calibration
Peephole with
crosshair target
for aiming
Reliability measure
“Left” eye field
Print and left/
right toggle
Start Button
Self-adjusting
hand strap
11
Charging Jack Receptacle
Receptacle for
RS232 Connection
Battery Compartment
Fixation LEDs
Distance Sensor
IR link to printer
12
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.
Battery
• 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: 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.
13
Plus or Minus Cylinder Convention
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.
Diopter 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.
14
Controls
Child/Adult Calibration
• Clears readings
• Changes child/adult
Calibration by holding it down
Left/Right Toggle & Print
• Selects single eye to re-test
or switches back to regular
test.
• Prints results (hold button
down while aiming patient
side of SureSight at printer
until you hear “tah-dah”)
“GO” Button
• Unit on: starts test
• Unit off: recalls old readings
The buttons on the back of the instrument function as follows:
The instrument will turn off when unused for one minute. Any button pressed on
the SureSight will bring up results.
15
Operating Instructions
• 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 6 - see Adult/Child
Calibration Section, Page 20 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
• 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
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.
the unit to the left eye and align the cross hair over the left eye’s pupil
……
16
• 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
• To stop a test at any time, hold any button until 5 tones sound.
• When the unit is off, 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.
nd
• Do not send 2
printout to printer before 1st printout has completed printing
17
Important Operating Tips
To insure accurate results and quick tests:
• Ambient Lighting:
- 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.
• Entry Angle
- Position unit straight and level with patient
- Rotate unit to test left eye
• Fixation: “Look at the red light”
- Remind patient and monitor fixation
• Correct Distance/Not Taking Readings?
- Are you square and level?
- Scan around the pupil
- Ask patient if they see the red light
- When over-refracting through glasses, aim higher
Helpful hints for testing pre-schoolers
• Helpful phrases that will grab the child’s attention.
- “Look into the video camera while I take a movie of you.”
- “Look in the green circle at the red dot inside and you will hear a little birdie
chirp.”
-“Look at the red dot inside the flashing green lights and tell me when it
changes color.”
• Helpful tips to keeping a child still while administering the
test
- Have child sit in his/her parent’s lap
- Have child lie down
18
Results
Sphere
Cylinder
Reliablity
Number
Axis
Child/Adult
Mode
Reliability Number 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 >
is the sphere in diopters.
• S
• C
is the cylinder power in diopters.
6.
A +9.99 or -9.99 indicates a reading outside the unit’s measurement range.
• The SW X.XXe after the date on the printout is the software revision level in
the SureSight unit.
19
Adult/Child Calibration
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).
Adult/Child Mode 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.
Replacement and Recycling of Battery
Replacing the 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) 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.
20
Charging
• 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.
Recycling Lithium Ion Battery
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:
Welch Allyn Welch Allyn Canada
RECYCLE BATTERY RECYCLE BATTERY
4341 State Street Road 160 Matheson Blvd. East
Skaneateles Falls, NY Mississauga, Ontario
13153-0220 CANADA L4Z 1V4
For locations outside the U.S. and Canada consult your local recycling authority for
correct disposal of batteries.
21
Screening Mode and Software Updates
Screening 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 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.
the difference in mean spherical power between
Updating SureSight Software
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.
22
Hand Strap Replacement
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.
Cleaning and Sterilization of the SureSight
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.
Do not sterilize SureSight or any of its components.
All windows on the SureSight can be cleaned with a soft cloth moistened with
70% Isopropyl Alcohol or any standard window cleaner.
Keep front window clean to insure proper function.
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.
23
Service, Calibration, and Warranty Information
The serial number is located on a label inside the battery door.
Warranty
SureSight Instrument
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.
NOTE: Return of the instrument registration card is required for proof of purchase
and warranty validation, and to automatically receive free software upgrades that
may occur during the warranty period.
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Service and Warranty
USA + 1 315 685 4560
800 535 6663
Canada 800 561 8797 China + 86 216 327 9631
European Call Center + 353 46 906 7790 France + 33 15 569 5849
Germany + 49 747 792 7186 Japan + 81 33 219 0071
Latin America + 1 305 669 9003 Netherlands + 31 15 750 5000
Singapore + 65 6419 8100 South Africa + 27 11 777 7555
United Kingdom + 44 207 365 6780 Sweden + 46 85 853 6551
Australia + 61 29 638 3000
800 074 793
SureSight Rechargeable Battery
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.
Calibration and Maintenance
When the calibration symbol is shown, it indicates that it has been 18
months since the unit was last calibrated. It is recommended that you
send the unit in for re-calibration.
Welch Allyn recommends that the SureSight be recalibrated annually.
Arrangements may be made by returning the SureSight registration card or by
contacting Welch Allyn’s Technical Service Department. A moderate fee is
charged for re-calibration.
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Guidance and Manufacturer’s Declarations
Emissions and Immunity Information
The SureSight is intended for use in the electromagnetic environment specified below. The
customer or user of the SureSight should assure that it is used in such an environment.
* SureSight is battery-powered and has no cable connections in use.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic
emissions
IEC 61000-3-2
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Electromagnetic Emissions
Group 1 The SureSight uses RF energy only for its internal
Class B The SureSight is suitable for use in all establishments,
NA *
NA *
function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
including domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
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Electromagnetic Immunity
The SureSight is intended for use in the electromagnetic environment specified below. The
customer or the user of the SureSight should assure that it is used in such an environment.
Immunity test IEC 60601
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
test level
±6 kV contact
±8 kV air
±2 kV for power
supply lines
±1 kV for input/output
lines
±1 kV differential
mode
±2 kV common mode
>95% dip in 0.5 cycle
60% dip in 5 cycles
30% dip for 25 cycles
>95% dip in 5
seconds
3 A/m 3 A/m Power frequency magnetic
Compliance level Electromagnetic
±6 kV contact
±8 kV air
NA* Mains power quality
NA* Mains power quality
NA* Mains power quality
environment – guidance
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
should be that of a typical
commercial or hospital
environment.
should be that of a typical
commercial or hospital
environment.
should be that of a typical
commercial or hospital
environment. If the user of
the SureSight requires
continued operation during
power mains interruptions,
it is recommended that the
SureSight be powered
from an uninterruptible
power supply or a battery.
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
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The SureSight is intended for use in the electromagnetic environment specified below. The
Electromagnetic Immunity
customer or the user of the SureSight should assure that it is used in such an environment.
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic environment –
guidance
Portable and mobile RF
communications equipment should
be used no closer to any part of the
SureSight, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation
distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80
NA*
d = (1.17 )
MHz
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5
GHz
3 V/m
d = (1.17) 80 MHz to 800 MHz
d = (2.33) 800 MHz to 2.5 GHz
where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,
should be less than the compliance
level in each frequency range.
Interference may occur in the
vicinity of equipment marked with
the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
b
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a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the SureSight is used exceeds the applicable RF compliance level above, the SureSight should be observed
to verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the SureSight.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended Separation Distances Between Portable and
Mobile RF Communications Equipment and the SureSight Vision Screener
The SureSight is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or user of the SureSight can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the SureSight as recommended below,
according to the maximum output power of the communications equipment.
Separation Distance According to Frequency of Transmitter (m)
Rated Max.
Output Power of
Transmitter (W)
150 kHz to 80
MHz
d = (1.17)
80 MHz to 800
MHz
d = (1.17)
800 MHz to 2.5 GHz
d = (2.33)
0.01 0.117 0.117 0.233
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.70 3.70 7.37
100 11.70 11.70 23.30
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures,
objects, and people.
29
30
4341 State Street Road
Skaneateles Falls, NY 13153-0220
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