4341 State Street Road Skaneateles Falls, NY 13153-0220 703692 Rev.
Table of Contents Warnings & Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Mises en garde et symboles . . . . . . . . . . . . . . . . . . . . . . . . 4 Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Function and Intended Application . . . . . . . . . . . . . . . . . . . 10 Vision Disorders and Amblyopia . . . . . . . . . . . . . . . . . . 10 SureSight™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Hand Strap Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Cleaning and Sterilization of the SureSight . . . . . . . . . . . . 24 Service, Calibration, and Warranty Information . . . . . . . . . Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Service and Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . SureSight Rechargeable Battery . . . . . . . . . . . . . . . . . . Calibration and Maintenance. . . . . . . . . . . . . . . . . . . . .
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. 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.
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.
ETL listed: UL2601-1, CSA C22.2 No. 601.1, IEC 60601-1, AS 3200.1. IEC 60601-1-2 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.
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. 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.
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.
IPXØ : Non protégé contre l’infiltration d'eau. Ne pas utiliser en présence d'anesthésiques inflammables. Equipement de type BF. Double isolation. Homologations ETL : UL 2601-1, CSA C22.2, No 601.1 et IEC 606011, AS3200.1, IEC 60601-1-2 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.
Note: This product complies with current required standards for electromagnetic interference and should not present problems to other equipment or be affected by other devices. As a precaution, avoid using this device in close proximity to other equipment. 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.
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 Reliability measure: Indicates number of and variation among measurements for the given eye Battery voltage: 7.
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 µW at a wavelength of 785 nm. Patents: US 6,007,204 and Des. 413,979 and International Patents Pending Office illumination: Not for use in direct sunlight. Indoor operation only. Materials: This product is latex free. Electromagnetic Compatibility: FCC Part 15, Class A (USA) This device complies with CFR 47 Part 15, Class A of the FCC Rules.
Function and Intended Application Thank you for purchasing the Welch Allyn SureSight™ Vision Screener. Please read and follow the instructions found in this manual before using your new Vision Screener to ensure accurate and reliable service. Vision Disorders and Amblyopia Amblyopia (lazy eye) is the leading cause of monocular blindness in North America for those under 70.
SureSight™ That’s why Welch Allyn created SureSight™, the first objective, accurate vision test that ensures reliable early detection of refractive error, the primary vision disorder in children. Early detection improves outcomes and reduces treatment duration. The handheld SureSight vision screener addresses the problems associated with eye chart acuity screenings - and it’s effective anywhere in the office or offsite.
SureSight Display, Controls, and Features Peephole with crosshair target for aiming Reliability measure “Left” eye field “Right” eye field Sphere (see glossary) Cylinder (see glossary) Self-adjusting hand strap Difference between the eyes Child/adult calibration Start Button Print and left/ right toggle 12
Charging Jack Receptacle Battery Compartment Fixation LEDs Distance Sensor IR link to printer 13 Receptacle for RS232 Connection
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 for offsite screenings.
Controls The buttons on the back of the instrument function as follows: Left/Right Toggle & Print Clear and Child/Adult Calibration • Selects single eye to re-test or switches back to regular test. • Clears readings • Prints results (hold button down while aiming patient side of SureSight at printer until you hear “tah-dah” • Changes child/adult (hold down) “GO” Button • Unit on: starts test • Unit off: recalls old readings The instrument will turn off when unused for 1 minute.
Test Procedure: • Push the “GO” button on the unit • Check that the patient is fixated correctly throughout the test. • Position the unit at the correct distance from the patient: • • When the unit is too far away, you will hear slow, low-pitched beeps. •••• Slowly move closer. 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 crosshair will flash in synch with the tones.
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.
Sphere Reliability Number Cylinder Difference Child/Adult Mode Results Reliability Number indicates the number of good readings obtained and their consistency, based on a 1 to 9 scale (higher numbers are 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. S is the sphere, or power of the eye measured in diopters.
Approximate Relationship of Sphere to Visual Acuity Negative (-) Diopters Myopia (NearSightedness) Hyperopia (Far- Positive (+) Diopters Sightedness)00 20/20 0.0 20/20 0.0 -0.5 20/30-40 +1.0 20/20 -0.8 20/50 +2.0 20/20 -1.0 20/60 +3.0 20/25 -1.25 20/70 +3.25 20/30 -1.75 20/100 +3.75 20/40 -2.0 20/200 +4.0 20/40-50 -3.0 20/285 +4.3 20/50 -4.0 20/420 +5.0 20/70 -5.0 20/565 00 Ages 5-15 Referral Criteria 6 Months 3-5 years* Adults (>10 years) Sphere <-2.0 or >+3.
• S – Sphere: Negative numbers are representative of myopia, or nearsightedness. Myopia is when distant images are blurry resulting from too much focusing power in the lens and cornea (i.e., the eye is too long). The light rays focus the image in front of the retina rather than at the retina. Positive numbers indicate hyperopia, or far-sightedness.
Plus or Minus Cylinder Convention Different eye care providers express astigmatism in different forms. Ophthalmologists typically express it in plus form, which is how the Suresight has been pre-set. Optometrists typically use the minus cylinder convention. If you wish to change your unit to the minus 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.
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.
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 RECYCLE BATTERY 4341 State Street Road Skaneateles Falls, NY 13153-0220 Welch Allyn Canada RECYCLE BATTERY 160 Matheson Blvd.
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.
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.
Service and Warranty 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. Technical Service Department Welch Allyn, Inc.
Appendix Glossary of Terms Amblyopia: An uncorrectable marked loss of visual acuity in one eye; “lazy-eye”. Causes of amblyopia include: refractive errors, strabismus, and cataracts. Anisometropia: The difference in refractive error between the two eyes, also known as refractive difference. Astigmatism: A refractive error due to an uneven curvature of the cornea, resulting in asymmetrical focus which blurs some of what the person sees.
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4341 State Street Road Skaneateles Falls, NY 13153-0220
