SureSight AutoRefractor User Guide

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

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. 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. Battery replacement: Replace with Welch Allyn model # 72420 Lithium Ion battery only.

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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. 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. 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. IPXØ: Not protected against the ingress of water. Not for use in the presence of flammable anesthetics.

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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

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.

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Authorized European Representative Address: European Regulatory Manager Welch Allyn, Ltd. Kells Road, Navan County Meath, Republic of Ireland Telephone: 353-46-28122

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 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.

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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

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”

Class II equipment:

Continuous operation.

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

Measurement Range:

Sphere: +6.0 to -5.0 Diopters Cylinder: ( 3 Diopters

Battery voltage:

7.2v nominal (Lithium Ion)

Battery life:

More than 3 hours of continuous usage

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Low-Battery warning:

Indicates 10 - 15 minutes usage remains

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 825-1 (1996) pending and EN60825-1 (1996) pending

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.

Electromagnetic Compatibility:

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.

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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.

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SureSight Display, Controls, and Features

Peephole with crosshair target for aiming

“Right” eye field

Reliability measure Sphere

“Left” eye field

Cylinder Axis Print and left/ right toggle Start Button

Clear results and Child/adult calibration

Self-adjusting hand strap

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Charging Jack Receptacle

Battery Compartment

Fixation LEDs

Distance Sensor

IR link to printer

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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.

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.

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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.

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Controls The buttons on the back of the instrument function as follows:

Child/Adult Calibration Left/Right Toggle & Print •

Clears readings

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Changes child/adult Calibration by holding it down

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Selects single eye to re-test or switches back to regular test.

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Prints results (hold button down while aiming patient side of SureSight at printer until you hear “tah-dah”)

“GO” Button •

Unit on: starts test

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Unit off: recalls old readings

The instrument will turn off when unused for one minute. Any button pressed on the SureSight will bring up results.

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Operating Instructions •

Push any button to turn on the unit.

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Position the patient so that eye levels can be adjusted for unit use.

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Press the child/adult button until you hear a beep to choose the appropriate calibration. (Child/Adult Calibration cut over age is 8 - see Adult/Child Calibration Section, Page 20 for more information).

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Explain the test procedure to the patient:

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“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.

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Push the “GO” button on the unit and check that the patient is fixated correctly during the test.

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Position the unit at the correct distance from the patient: • •

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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. ° ° ° ° °

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When the test of the right eye is complete, you will hear the “tah-dah” sound.

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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.)

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At the end of the test, you will hear the “tah-dah” sound again.

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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.

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If you are at the correct distance and not acquiring data:

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• 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.

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When the unit is off, any button wakes the unit and displays the previous results.

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To Print: Press the print button until beep sounds. Keep unit aimed at printer during beep.

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Do not send 2nd printout to printer before 1st printout has completed printing

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Important Operating Tips To insure accurate results and quick tests:

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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.

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Entry Angle - Position unit straight and level with patient - Rotate unit to test left eye

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Fixation: “Look at the red light” - Remind patient and monitor fixation

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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.”

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Helpful tips to keeping a child still while administering the test - Have child sit in his/her parent’s lap - Have child lie down

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Reliablity Number Sphere

Axis

Cylinder

Child/Adult Mode

Results 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

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5 is marginal / repeat the test if possible

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<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 sphere in diopters.

•

C is the cylinder power in diopters.

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.

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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 •

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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.

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