Welch Allyn SureSight - 703692 - Rev B
Contents
1. Results Reliability Number indicates the number of good readings obtained and their consistency based on a 1 to 9 scale higher numbers are better gt 6 is typically acceptable e 5 is marginal repeat the test if possible e lt 4is 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 Negative numbers indicate myopia nearsightedness positive numbers indicate hyperopia far sightedness C is the cylinder a measure of astigmatism or irregular focus of the eye D is the difference in the mean spherical power between the two eyes displayed in child mode only An asterisk on a reading in child mode indicates it is in AAP pre school referral range 9 99 or 9 99 indicates a reading outside the unit s measurement range Approximate Relationship of Sphere to Visual Acuity Myopia Near Bes Hyperopia Far Negative Diopters Sightedness Positive Diopters Sightedness 0 0 20 20 0 0 20 20 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 Ages 5 15 Referral Criteria 6 Months 3 5 years Adults gt 10 years Sphere lt 2 0 or gt 3 52. Explain the test procedure to the patient e Now will check your eyes You will see a red light in the middle of the blinking green lights Position yourself at eye level and square with the face of the patient 15 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 e When the unit is too far away you will hear slow low pitched beeps e Slowly move closer At the correct distance 14 you will hear a steady low tone e When the unit is too close you will hear quick high pitched beeps e The crosshair will flash in synch with the tones Look through the peephole and align the crosshair on the pupil of the patient s right eye While the unit is acquiring data you will hear a very high pitched chirping sound over the steady low tone If you are not acquiring data steady tone without acquiring data chirps e Scan around the pupil an outward moving spiral until chirps begin then hold this location e Ask the patient if they can see the red light When the test of the right eye is complete you will hear the tah dah sound Testing resumes after 1 second so you do not need to press any buttons for the left eye test Without changing position rotate the unit to the left eye and align the crosshair over the pupil Repeat test At the end of t
3. 0008 SureSight Rechargeable Battery Welch Allyn Lithium lon 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 26 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 An astigmatic eye typically has areas of the cornea that are steeper or flatter than normal which produces distorted vision Cylinder A measure of the power of astigmatism False Negative A test or procedure that indicates the abnormality or
4. 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 uW at a wavelength of 785 nm US 6 007 204 and Des 413 979 and International Patents Pending Not for use in direct sunlight Indoor operation only This product is latex free FCC Part 15 Class A USA 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 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 However if risk factors are detected by age 4 95 of patients can have their vision saved and avoid the lifelong effects of amblyopia which may include a dramatically higher chance of loss of sight in the other eye learning delays and limitation of career choices Two thirds of children with amblyopic risk factors have refractive error when the eye s optics fail to clearly focus images on the retina These include anisometropia
5. unequal optical power of the two eyes myopia and hyperopia near and farsightedness and astigmatism asymmetry of focus Furthermore 20 of teenagers suffer from a refractive error that requires corrective lenses that can affect educational development when untreated The American Academy of Pediatrics Family Practice Ophthalmology and Optometry all advocate pre school vision screening especially a key check of children aged 3 to 4 The latest research also indicates that it is a good idea to check refraction in infants and to begin treatment by age one Early detection reduces treatment time and expense and improves outcomes Traditionally pediatricians and family physicians use visual acuity eye charts to screen for refractive vision problems Unfortunately acuity testing of pre schoolers suffers from low compliance poor specificity false positives and poor sensitivity false negatives 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 And since minimal patient interaction is required SureSight can be used for screening infants or handicapped patie
6. Welch Allyn SureSight Welch 4341 State Street Road Skaneateles Falls NY 13153 0220 703692 Rev Table of Contents Warnings amp SYMBOL kth al ot Mente ern 1 Mises en garde et symboles 4 Technical 5 8 Function and Intended Application 10 Vision Disorders and Amblyopia 10 SUFESIONE M tee 11 SureSight Display Controls and Features 12 First Time Seu bit da iaa rare ee 14 14 COMO San aid ee 15 Pretest Sa aon owl 15 Test Procede coo 4 bee hE dite dad 16 Important Operating 5 17 Helpful hints for testing pre schoolers 17 R SUM ans ne GA a Re 18 Approximate Relationship of Sphere to Visual Acuity 19 Referral Criteria Pas NE D AR 19 Plus or Minus Cylinder Convention 21 Updating SureSight Software 21 Replacement and Recycling of Battery 22 Replacing the 22 CHAINES O be eed 22 Recycling Lithium lon Battery 23 Hand Strap 24 Cleaning and Sterilization of the SureSight 24 Service Calibration and Warranty Inform
7. ary 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 counterclockwise 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 14 Controls The buttons on the back of the instrument function as follows Clear and Child Adult Left Right Toggle amp Print Calibration e Selects single eye to re test or switches back to regular test e Clears readings e Prints results hold button down while aiming patient side of SureSight at printer until you hear tah dah e Changes child adult hold down GO Button e Unit on starts test e 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 Position the patient so that the test can be conducted level with and square to patient s eyes Choose the appropriate calibration using the child adult button child mode for 6 yr and under Hold button until you hear a double beep and see the desired icon on the LCD
8. atients for approximately continuous hours e 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 e Unit will turn off when charging 22 Recycling Lithium lon 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 23 Hand Strap Replacement 1 Position the unit so that the hand strap is facing up and the battery door com partment is toward you 2 Push the hand strap forward until the square notches beneath are visible hold the strap in this position with one hand 3 Insert the tool provided into one of the notches and press o
9. ation 25 Warranty RS Rte tote 25 Service and 26 SureSight Rechargeable 26 Calibration and 26 ii AR 27 Glossary of A amet er 27 Warnings amp Symbols PEEP ATTENTION Refer to the operating instructions This symbol A 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 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
10. disease being investigated is not present when in fact it is False Positive A test or procedure that indicates the abnormality or disease being investigated is present when in fact it is not Focal Length The distance at which a lens focuses Hyperopia Farsightedness close images are blurry due to the rays of light converging on the retina short of the focal length at which they would be in focus Myopia Nearsightedness a condition in which distant images are blurry resulting from too much focusing power in the lens and cornea The light rays focus in front of the retina rather than at the retina Sphere The power of the eye which determines hyperopia and myopia Strabismus Intermittent or constant misalignment of the eyes sometimes referred to as muscle problems 27 28 29 30 WelchAllyn SureSight 4341 State Street Road Skaneateles Falls NY 13153 0220
11. e measurements indicate the difference in power between the two eyes This is only displayed when the unit is in child calibration This difference is mean sphere D S C computed taking into account both the sphere and cylinder reading It will typically be different than the algebraic difference between spheres Peter s H G Peter s Multiple Tables Borish Clinical Refraction Vol 1 Y Edition 371 20 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 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 Updating SureSight Software If it is necessary or desired to update the unit software 1 Connect the cable supplied with the software disk to a PC IBM compatible 486 processor Windows 3 1 or higher RS232 port 2 Connect the ot
12. he 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 when the test stops You must re test that eye To stop a test at any time hold any button until 5 tones sound Important Operating Tips To insure accurate results and quick tests e Ambient Lighting Don t perform by uncovered windows Dimmed light can help for adults w small pupils e Too dim can make it harder to find the pupil for those with dark eyes e Entry Angle Position unit straight and level with patient Rotate unit to test left eye e Fixation Look at the red light Remind patient and monitor fixation e Correct Distance Not Taking Readings you square and level Scan around the pupil Ask patient if they see the red light Helpful hints for testing pre schoolers e Helpful phrases that will grab the child s attention look into the video camera while 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 e Helpful tips to keeping a child still while administering the test have child sit in his her parent s lap have child lie down Sphere Reliability Number Child Adul Mode Cylinder Difference
13. her 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 6 View the DIP switches inside the battery compartment located on the button side of the unit 7 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 21 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 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 counterclockwise 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 Chargin e Acharged unit can test p
14. invisible laser radiation Only the battery cover is to be opened by the user Battery replacement Replace with Welch Allyn model 72420 Lithium lon 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 Oo bb gt 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 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 Do not use a battery pack which appears to be deformed leaking corroded or is otherwise irregular If electrolyte leaking from battery contacts your skin or eyes rinse with running water and immediately seek medical attention IPX Not protected against the ingress of water Not for use in the presence of flammable anesthetics Type BF Equipment Double Insulated ETL listed UL2601 1 CSA C22 2 N
15. lt 1 0 or gt 2 0 lt 1 0 or gt 2 0 Cylinder gt 1 0 gt 1 0 Difference gt 1 5 gt 1 0 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 19 5 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 farsightedness Hyperopia is a condition in which blurred vision occurs at a close distance due to the rays of light converging on the retina short of the focal length at which they would be in focus Causes also may include a weakness in the ability of the lens to focus particularly at closer distances The C displayed represent the cylinder which is a measure of astigmatism or asymmetry of focus Astigmatism is a refractive error due to an uneven curvature of the cornea blurring some of what the person sees An astigmatic eye typically has areas of the cornea that are steeper or flatter than normal which produces distorted vision The D found under the left ey
16. nts 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 11 SureSight Display Controls and Features Peephole with crosshair target for aiming Reliability measure Right eye field Left eye field Sphere see glossary D H Cyinder_ IT see glossary IL Child adult calibration Start Button rint and left right toggle 12 Charging Jack Receptacle Receptacle for Battery Compartment RS232 Connection Fixation LEDs Distance Sensor IR link to 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 for offsite screenings 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 necess
17. o 601 1 IEC 60601 1 AS 3200 1 EM IEC 60601 1 2 iere us 74227 wanna Australia EMC Framework Compliance LANE COVE NSW AUSTRALIA N344 The CE mark on this device indicates that it has been tested and conforms to the provisions noted within the 93 42 EEC Medical 005 Device Directive Mises en garde et symboles gt gt PP gt gt gt ATTENTION Consulter le mode d emploi Ce symbole A signale l utilisateur la pr sence de renseignements importants relatifs au fonctionnement ou l entretien de l instrument dans les documents qui l accompagnent L entretien ou la r paration ne doivent tre effectu s que par un personnel comp tent habilit Cet instrument ne contient pas de pi ces r parables par l utilisateur L ouverture de ce dispositif risque d exposer l utilisateur un rayonnement laser invisible nocif Utiliser uniquement avec des chargeurs Welch Allyn s rie 710 Pi ces et accessoires de rechange Utiliser uniquement les pi ces et accessoires de rechange autoris s sp cifi s dans ce manuel Consulter la section Entretien de ce manuel pour des informations suppl mentaires Ne pas st riliser l instrument ni aucun de ses composants Utiliser uniquement avec une imprimante conforme la norme 60601 1 ou utiliser l imprimante distance du patient Un d montage de l instrument au del des recommandations de ce manuel annule la garantie Confier toutes r para
18. 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 Technical Specifications Technology Working distance Distance detection Eyepiece Data acquisition time Data acquisition Reliability measure Battery voltage Battery life Low Battery warning Interfaces Stand Weight Dimensions Class Il equipment Transport Storage Operating Measurement Range Welch Allyn proprietary autorefractor hardware algorithm 14 inches 35 cm Automatic with audible and visual cues Illuminated target for easy aiming 2 4s eye Measures and averages 5 to 8 readings eye Indicates number of and variation among measurements for the given eye 7 2v nominal Lithium lon More than 3 hours of continuous usage Indicates 10 15 minutes usage remains Remove infrared link to thermal printer RS 232 interface for IBM compatible PC for future software upgrades data transfer to electronic medical records Compact charger and SureSight storage Approximately 2 0 lbs 0 9 Kg 6 5 7 75 x 2 Continuous operation 20 C 49 C 10 100 Max 500hPa 1060hPa Altitude 10 C 30 C 30 75 Max 500hPa 1060hPa Altitude Sphere 5 5 to 4 1 2 Diopters Cylinder 3 Diopters Laser safety Patents Office illumination Materials Electromagnetic Compatibility
19. s 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 25 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 4341 State Street Road Skaneateles Falls NY 13153 0220 Telephone 1 800 535 6663 Fax 1 315 685 4653 Technical Services In Canada Telephone 1 800 561 8797 Fax 1 905 890
20. ser un bloc batterie qui semble fuir ou tre d form corrod ou anormal En cas de contact cutan ou oculaire avec une fuite d lectrolytes de la batterie rincer l eau courante et consulter imm diatement un m decin IPX Non prot g contre l infiltration d eau Ne pas utiliser en pr sence d anesth siques inflammables Equipement de type BF Double isolation 95 Homologations ETL UL 2601 1 CSA C22 2 N 601 1 et IEC 60601 1 200 1 IEC 60601 1 2 WELCH ALLYN AUSTRALIA PTY LTD 18 20 ORION ROAD LANE COVE NSW 2066 AUSTRALIA N344 Obedece la norma australiana EMC Framework N gt C La marque CE appliqu e sur ce dispositif indique qu il a t teste et d clar conforme aux dispositions de la directive 93 42 de la CEE 0050 sur les appareils m dicaux Authorized European Representative Address European Regulatory Manager Welch Allyn Ltd Navan Business Park Dublin Road Navan County Meath Republic of Ireland Telephone 353 46 67700 Fax 353 46 28536 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
21. tions Welch Allyn ou un repr sentant agr par Welch Allyn list dans la section Informations sur les r parations l talonnage et la garantie L ouverture de ce dispositif risque d exposer l utilisateur un rayonnement laser invisible nocif Seul le couvercle de la batterie peut tre ouvert par l utilisateur Remplacement de la batterie Remplacer uniquement par une batterie au lithium Welch Allyn mod le n 72420 EE Ne pas essayer de d monter ou de modifier le bloc batterie contient pas de pieces r parables par l utilisateur Ne pas essayer de souder directement sur le bloc batterie Ne pas essayer de relier les bornes positive et n gative l une a l autre ou a d autres dispositifs Attention Des proc dures de contr le de r glage ou de performance autres que celles qui sont sp cifi es dans cette notice peuvent entrainer une exposition dangereuse au rayonnement Le produit comprend deux ouvertures internes l int rieur 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 un endroit o la temp rature ambiante est inf rieure 0 ou sup rieure 40 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 Ne pas utili
22. utward 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 24 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 i
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