Welch Allyn SureSight Manual
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4341 State Street Road
Skaneateles Falls, NY 13153-0220
719919 Rev. A

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Summary of Contents for Welch Allyn SureSight

  • Page 1 4341 State Street Road Skaneateles Falls, NY 13153-0220 719919 Rev. A...
  • Page 3: Table Of Contents

    Vision Disorders and Amblyopia ....10 SureSight™ ........11 SureSight Display, Controls, and Features .
  • Page 4 Service and Warranty ......26 SureSight Rechargeable Battery ....26 Calibration and Maintenance.
  • Page 5: Warnings & Symbols

    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.
  • Page 6 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.
  • Page 7 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.
  • Page 8: Mises En Garde Et Symboles

    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.
  • Page 9 à d’autres appareils ni être affecté par leur fonctionnement. Remplacement de la batterie : Remplacer uniquement par une batterie 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.
  • Page 10 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...
  • Page 11 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.
  • Page 12: Technical Specifications

    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.
  • Page 13: Environmental Specifications

    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...
  • Page 14: Function And Intended Application

    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.
  • Page 15: Suresight

    And since minimal patient interaction is required, SureSight can be used for screening infants or handicapped patients. SureSight can also automatically test adults. With SureSight you can finally screen for serious vision problems - at well child visits or anytime - efficiently and effectively.
  • Page 16: Suresight Display, Controls, And Features

    SureSight Display, Controls, and Features Peephole with crosshair target for aiming Reliability measure “Left” eye field “Right” eye field Sphere (see glossary) Cylinder Self-adjusting (see glossary) hand strap Difference between the eyes Child/adult calibration Start Button Print and left/ right toggle...
  • Page 17 Charging Jack Receptacle Receptacle for Battery Compartment RS232 Connection Fixation LEDs Distance Sensor IR link to printer...
  • Page 18: First Time Set-Up

    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.
  • Page 19: Controls

    • Unit on: starts test • Unit off: recalls old readings The instrument will turn off when unused for 1 minute. Any button pressed on the SureSight will bring up results. Pre-test Set-up: • Push any button to turn the unit on.
  • Page 20: Test Procedure

    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. •••• •...
  • Page 21: Important Operating Tips

    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. •...
  • Page 22: Results

    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 •...
  • Page 23: Approximate Relationship Of Sphere To Visual Acuity

    Referral Criteria 3-5 years* Sphere <- > 1.0 or +4.0 Cylinder <-1.5 Difference > Readings outside the normal limits should be confirmed prior to referral. It is recommended that referral criteria be agreed upon between you and the eye care specialist receiving your referrals. With adults, it is suggested that the eye chart be used to confirm any apparent reading outside the normal limits.
  • Page 24 • S – Sphere: Negative numbers are representative of myopia, or near- sightedness. 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.
  • Page 25: Plus Or Minus Cylinder Convention

    Plus or Minus Cylinder Convention The Suresight has been pre-set in 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.
  • Page 26: Replacement And Recycling Of Battery

    • 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). •...
  • Page 27: Recycling Lithium Ion Battery

    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.
  • Page 28: Hand Strap Replacement

    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.
  • Page 29: Service, Calibration, And Warranty Information

    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...
  • Page 30: Service And Warranty

    Fax: 1-905-890-0008 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.
  • Page 31: Appendix

    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.
  • Page 32: Guidance And Manufacturer's Declarations

    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.
  • Page 33 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 Compliance level Electromagnetic test level environment –...
  • Page 34 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 Compliance Electromagnetic environment –...
  • Page 35 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.
  • Page 40 4341 State Street Road Skaneateles Falls, NY 13153-0220...

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