Zeiss Humphrey Field Analyser II i-Series User manual 1

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HUMPHREY

FIELD ANALYZER II - i series

USER’S GUIDE

Model 720i • Model 740i • Model 745i • Model 750i

Carl Zeiss Meditec Inc. 5160 Hacienda Drive Dublin, CA 94568

General Inquiries (925) 557-4100

(877) 486-7473

www.meditec.zeiss.com

Customer Service (877) 486-7473

In Europe please contact:

Carl Zeiss Jena GmbH Carl Zeiss Promenade 10 Jena 077405 Germany

Ph: +49-3641-642076 Fax: +49-3641-642155

www.zeiss.de

Trademarks Humphrey Field Analyzer is a registered trademark of Carl Zeiss Meditec Inc., STATPAC, FastPac, and SITA are trademarks of Carl Zeiss Meditec Inc., Hewlett-Packard and LaserJet are registered trademarks of Hewlett-Packard Corporation. IBM is a registered trademark of the International Business Machines Corporation. GoPrint is a trademark of the AeroComm company.

Every effort has been made to ensure that the information contained in this manual is true and correct at the time of printing. Any omissions or errors are unintentional and will be corrected in future releases.

This book may not be reproduced in whole or in part by any means of information storage, retrieval, or reproduction without written permission from Carl Zeiss Meditec Inc.

Humphrey® Field Analyzer II - i series

User’s Manual Revision Control

PART NUMBER REVISION TITLE RELEASE DATE

51680-1 B Humphrey® Field Analyzer II - i series 3-2003

User’s Guide Models 720i, 740i, 745i, 750i

Table of Contents (this manual contains 314 pages)

Introduction/

Instrument Setup

(18 pages)

General

Operation

(24 pages)

Introduction/Instrument Setup 1-1

About Visual Fields 1-2

The Humphrey Advantage 1-5

Using This Guide 1-8

Safety Precautions 1-9

System Components 1-12

Additional Components 1-14

System Assembly 1-17

General Operation 2-1

General Information 2-2

The Main Menu Screen 2-9

System Setup 2-10

Additional Setup 2-21

Setting-up

Tests

(24 pages)

Test Parameters &

Strategies

(16 pages)

Help Screens 2-23

Setting-up Tests 3-1

Selecting the Test Pattern and Test Eye 3-2

Entering Patient Data 3-8

Using Trial Lenses 3-19

Preparing the Patient 3-22

Test Parameters & Strategies 4-1

Setting Test Parameters 4-2

Test Strategies 4-4

SITA™ Testing 4-10

Blue-Yellow (SWAP) Testing 4-11

Alternate Color Testing 4-16

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Testing

(18 pages)

Testing 5-1

Start Test Options 5-2

Monitoring and Maintaining the Patient’s Eye Position 5-4

Supplemental Testing 5-7

Test In Progress 5-10

Test Complete Options 5-14

Testing: A Step-by-Step Guide 5-16

Test

Reliability

(8 pages)

STATPAC Analysis &

Printing Results

(30 pages)

Test Reliability 6-1

Factors Affecting Reliability 6-2

Patient Compliance 6-2

Patient Fixation 6-3

Trial Lenses 6-3

Evaluating Reliability 6-4

Fixation Losses 6-4

False Positive Errors 6-4

False Negative Errors 6-6

Fluctuation Values 6-6

STATPAC Analysis & Printing Results 7-1

Introduction to STATPAC Analysis 7-2

Threshold Test Printout Formats 7-4

SITA Printout Formats 7-21

Blue-Yellow Printout Formats 7-23

Printing Current Threshold Test Results 7-25

Screening Printout Formats 7-26

Printing Current Screening Test Results 7-27

Printing Previously Saved Test Results 7-28

Grayscale Symbols 7-30

Remote Printer Access 7-30

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File

Functions

(20 pages)

File Functions 8-1

File Functions Menu 8-2

Retrieving the File Directory 8-4

Selecting Tests from the Directory 8-6

Performing File Functions 8-11

Organizing Patient Files 8-20

Database

Management

(22 pages)

Custom

(20 pages)

Testing

Database Management 9-1

Introduction to Database Management 9-2

Patient Database Protection Procedures 9-3

Configuration Backup and Restore 9-5

How to Handle Database Failures 9-10

Merge Database 9-20

Cleanup Hard Disk Database 9-21

Practices with Multiple Humphrey Field Analyzers 9-22

Care and Handling of Removable Storage Media

Custom Testing 10-1

Creating Custom Tests 10-2

Deleting Custom Tests 10-15

9-22

Performing Custom Tests 10-17

Printout Format

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10-19

(62 pages)

Kinetic

Testing

Kinetic Testing 11-1

Introduction to Kinetic Testing 11-2

Performing Manual Kinetic Perimetry 11-3

Pre-defined Kinetic Test Patterns 11-14

Running Automated Kinetic Tests 11-15

Social Security Administration Kinetic Disability Test 11-24

Special Mapping 11-27

Viewing Kinetic Tests 11-40

Printing Kinetic Tests 11-43

Designing a Custom Kinetic Test Pattern 11-48

Creating the SSA Aphakic (Size IV) Disability Test 11-57

Care &

(14 pages)

Appendix

(36 pages)

Cleaning

Care & Cleaning 12-1

General Use Principles 12-2

Cleaning the HFA II 12-2

Replacing Parts 12-4

Operating the Printrex Printer 12-10

Touch Screen Calibration 12-12

Using Data Disks 12-13

A HFA II Product Specifications A-1

B Warranty Statement and Notification of Copyright B-1

C Icon Glossary C-1

D Goldmann Conversion Tables D-1

E Test Patterns E-1

F Installing New HFA II Software F-1

G How SITA Works / Acknowledgments G-1

H Troubleshooting / Parts List H-1

Index

(6 pages)

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Introduction/Instrument Setup

About Visual Fields 1-2

The Humphrey Advantage 1-5

Using This Guide 1-8

Safety Precautions 1-9

System Components 1-12

Additional Components 1-14

System Assembly 1-17

You are about to use the most advanced automated perimeter available, the Humphrey Analyzer II (HFA II). This introductory section covers general information about the HFA II, including a brief discussion of visual fields and a summary of important instrument features.

Field

After reading Section 1 you will be familiar with:

• the importance of visual field testing

• general principles of perimetry

• unique features of the Humphrey Field Analyzer II

• installation and safety precautions

• connecting optional external printers.

Welcome

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1-2 INTRODUCTION / INSTRUMENT SETUP

ABOUT VISUAL FIELDS

When asked to assess one’s own vision, the average person often will confidently reply “I see 20/20”, “20/100” or whatever the result of their visual acuity test. Fortunately, doctors appreciate the complexities involved in evaluating visual function and rely on an extensive and varied battery of diagnostic tests and instruments as part of the ocular examination. Without question, one of the most essential tools in the modern ophthalmic office is the computerized perimeter, used to evaluate the visual field.

The purpose of visual field testing, or perimetry, is to provide information critical to:

• diagnosing ocular diseases, especially glaucoma

• evaluating neurological diseases

• monitoring the progress of ocular and neurological diseases.

Visual field testing can lead to early detection and treatment of disease. In the case of glaucoma, visual fields play a major role in identifying visual field defects and evaluating the efficacy of the therapy used to control the disease process.

What visual field When evaluating visual performance, clinicians are primarily interested in two retinal tests measure functions: resolution and contrast sensitivity. Resolution is the ability to identify discrete forms

(letters, numbers, symbols), and is commonly measured with the visual acuity test. Resolution rapidly diminishes with increasing distance from the fovea and is, therefore, a poor indicator of overall visual performance.

A better means of evaluating visual function—especially those areas less sensitive than the fovea—is contrast sensitivity testing. Contrast sensitivity is the ability to detect a stimulus (spot of light or other target) against a darker or brighter background. Standard Humphrey perimetry may be thought of as contrast sensitivity testing applied throughout the peripheral visual field.

In perimetry, the term “threshold” is used to describe a very specific level of stimulus detection. The threshold represents the point at which a stimulus is seen 50% of the time and missed 50% of the time. The assumption is that all stimuli brighter than the threshold value will be seen and all stimuli dimmer will be missed. Reviewing the threshold value at each point tested in the visual field is an important part of the diagnostic process.

Visual field tests can yield information that is general in nature, as with screening tests, or more exacting and quantitative, as with threshold tests. In deciding which test type is most appropriate for a patient the practitioner is influenced by many factors, including the patient’s presenting complaint, family history, age, degree of cooperation, and time available to run the test.

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INTRODUCTION / INSTRUMENT SETUP 1-3

BLIND SPOT

FOVEA

Normal versus The visual field normally extends more than 90° temporally, 60° nasally and superiorly, pathologic fields and about 70° inferiorly. That means a person can potentially perceive stimuli within this

range while staring at a fixed point.

Superior

60°

Temporal

60°

Nasal

70°

Inferior

90°

Figure 1.1: The Boundaries of the Normal Visual Field

A more comprehensive understanding of the normal field takes into account that visual sensitivity is not constant (or equal) throughout the range. As previously stated, vision is most acute at the fovea and decreases toward the periphery of the retina. It is easy to see why the visual field is often expressed as a “hill of vision in a sea of darkness”.

Figure 1.2: The Normal Hill of Vision

Several factors affect the normal hill of vision causing variations in its overall height and shape. Among them are a patient’s age, ambient light, stimulus size, and stimulus duration. In general, deviations from the normal hill are viewed as visual field defects and caused by some pathological change.

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1-4 INTRODUCTION / INSTRUMENT SETUP

A defect (or scotoma) is categorized as either relative or absolute. A relative defect is an area that has depressed vision or less than normal sensitivity; an absolute defect is an area where the perception of light is absent. The point at which the optic nerve enters the retina is referred to as the blind spot, and is an example of an absolute scotoma.

Some defect patterns are characteristic of certain diseases, a fact which makes visual field testing a valuable part of the diagnostic process. Furthermore, by having patients repeat the same tests at later dates, practitioners gain insight into the progression of the disease and the effectiveness of treatment.

Methods of testing Over the years, visual field testing devices have varied in size, complexity, and testing the visual field methodology. The fundamental premise has remained the same, however; patients must

respond when they see a stimulus.

In kinetic testing, a target of fixed stimulus characteristics is moved into the visual field from a non-seeing area, until it is detected by the patient. Typically, the target is brought toward the center from several directions and the operator marks the location at which the patient first detects the target (threshold point).

Kinetic test results can only be reliably related to specific parts of the visual field if points are joined to form an isopter, or ring of equal contrast sensitivity. Targets of varying size and brightness are used during one kinetic test, and for each different target, a different isopter is mapped. When reviewing several isopters, the clinician is visualizing different tiers in the hill of vision.

A second method of evaluating retinal function is known as static threshold testing. The term “static” refers to a stationary (rather than moving) stimulus being used.

In static testing, predefined test locations in the visual field are probed. Through a series of stimulus presentations of varying brightness intensities, the threshold value is determined for each test point. When evaluating static test results, clinicians are looking at the topography or contour of the hill of vision, and whether depressions are evident.

Patient fixation and In order for any visual field test to be clinically useful, it must yield reliable results. One test reliability important factor affecting reliability is the steadiness of patient fixation. Unless the eye being

tested accurately fixates on the target while responding to stimuli, the results are unreliable. Other factors adversely affecting reliability are:

• patient fatigue and anxiety

• poor test instructions

• patient discomfort

• improper near vision correction for central testing.

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INTRODUCTION / INSTRUMENT SETUP 1-5

Reasons for Certainly the advancements in microprocessor technology within the last 20 years have had computerized perimetry a profound effect on perimetry. Perimeters have evolved into a more precise measuring tool

yielding highly repeatable results.

These changes are better appreciated by examining the benefits computerized perimeters bring to both patient and professional:

• Reproducible testing conditions.

• Data storage capability; results can be compared over time and analyzed using expert system software.

• More sensitive testing; many researchers claim static perimetry to be superior to the kinetic method for identifying defects. Performed manually, static testing would be too time-consuming.

• Ease of operation; menu-driven software makes automated perimeters easy to learn and use.

THE HUMPHREY ADVANTAGE

Over 15 years of advancements in research, design and development are reflected in the Humphrey suggested by users from around the world who have generously shared their best ideas with Carl Zeiss Meditec. With over 30,000 Humphrey Field Analyzers in use worldwide, Carl Zeiss Meditec took on the challenge of improving the testing experience for the patient, the operator, and the practitioner. Here are some of the features which differentiate the HFA II from all other autoperimeters available today.

Field Analyzer II. Equally important, the latest models represent improvements

Ergonomic design The HFA II relieves many physical discomforts

associated with visual field testing. The chin rest and bowl shape allow patients to assume a more natural and relaxed sitting position when taking tests.

The special power table and instrument slider improve patient comfort by permitting the HFA II to extend out to the patient instead of the patient stretching toward the instrument. This is especially important for wheelchair bound patients.

The patient response button is easy to operate, especially for patients who have limited use of their hands; for instance, patients with arthritis. The uniquely-shaped button may be placed on a knee, lap or the arm of a chair for better leverage. The cord angles away from the patient for greater comfort. The response button will beep each time it is pressed to give immediate feedback to the patient and to the user.

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Easy operation Sophisticated instrumentation need not be complicated. The HFA II offers a number of features

intended to make the instrument easier to use:

• Touch screen design speeds data input.

• Menu and icon commands simplify operation.

• On-screen video eye monitor is standard on all models.

• Confirmation screens reduce unintentional data loss.

• A keyboard and trackball or mouse can be connected to the HFA II as optional data input devices.

Speedy testing Carl Zeiss Meditec’s SITA™ testing strategies allow precise visual field measurements

with unprecedented speed. With the SITA strategies, users can obtain visual field information in half the time it takes using conventional testing algorithms without compromising accuracy. SITA represents the very latest in autoperimetry technology and it is only available with your Humphrey Field Analyzer II.

Sophisticated data The Humphrey Field Analyzer’s statistical software, STATPAC™, provides immediate expert analysis with STATPAC™ system analysis of visual field test results. With STATPAC you can analyze test results at the time

of examination, store test results and analyze them at your convenience, or recall previously stored tests to analyze for comparative purposes.

STATPAC includes several exclusive features to help you identify visual field change:

• Using results from a single test, STATPAC can point out suspicious areas that otherwise might not be evident until subsequent tests were done.

• STATPAC can identify areas that look suspicious but which, in fact, compare favorably with normals data.

• Using results from a series of tests, STATPAC provides a highly sensitive and informative analysis of changes in the patient’s visual field over time.

• The Glaucoma Hemifield Test (GHT) compares points in the superior and inferior hemifields to provide a plain language analysis of test results.

• The HFA II provides separate databases for STATPAC analysis. These include databases for SITA and Blue-Yellow perimetry, in addition to the well-established databases for Full Threshold and FastPac test results.

• Another database consisting of stable glaucoma patients is used with the Glaucoma Change Probability Analysis for following change in the progress of the disease. This analysis is only available with Full Threshold testing.

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INTRODUCTION / INSTRUMENT SETUP 1-7

Blue-Yellow (SWAP) testing Blue-Yellow perimetry, also known as Short Wavelength Automated Perimetry, or SWAP, (model 745i and 750i) has performed better than standard computerized perimetry according to published

longitudinal studies. Working independently, researchers from U.C. Davis and U.C. San Diego have found that Blue-Yellow perimetry identified early glaucomatous visual field defects years before they could be detected using standard white-on-white perimetry.

Blue-Yellow perimetry differs from standard static White-on-White perimetry only in that a carefully chosen wavelength of blue light is used as the stimulus, and a specific color and brightness of yellow light is used for the background illumination. For more information on Blue-Yellow perimetry, see Section 4 and Section 7.

Automatic fixation monitoring The HFA II employs several methods for ensuring that patients maintain proper fixation of the

target during testing. All models are equipped with a video eye monitor which presents a view of the patient’s eye on-screen so that users can ensure proper patient fixation. Every HFA II also offers standard Heijl-Krakau blind spot monitoring.

Models 740i, 745i and 750i also offer Gaze Tracking: a patented, high precision system which uses real-time image analysis to verify the patient is looking at the fixation target and not looking around. The gaze tracking device is unaffected by the patient’s head position. A continuous record of fixation is available for monitoring on the test screen throughout the test. The gaze track graph is included on the printout to provide a permanent record of the patient’s fixation.

For patients who require a trial lens, the model 750i uses Head Tracking and Vertex Monitoring to help ensure that the patient’s eye is both centered behind the lens and is held at the proper distance from the lens. These features help to eliminate the trial lens as a possible source of unreliable visual field results.

Data protection features Visual field results need to be saved and protected for future use. The HFA II offers you a

number of data storage methods to file the results. Floppy disk data storage is available with all models of the HFA II. Magneto-optical disk backup is available on the model 750i of the HFA II and is optional with other models. There are a number of additional data protection features that work internally to safeguard your data from serious loss or damage. This User’s Guide describes in great detail the procedures for creating extra copies of your data.

Information on the internet New information about your HFA II may be found on the Carl Zeiss Meditec web site. The

internet address is : www.meditec.zeiss.com

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1-8 INTRODUCTION / INSTRUMENT SETUP

USING THIS GUIDE

To fully appreciate the capability of the HFA II and develop good testing techniques, we recommend that you rely on the User’s Guide as your training and reference manual. It has been designed to make learning easy. The concise step-by-step instructions and accompanying illustrations help you get started quickly and with more confidence.

We think you will enjoy working with the HFA II. The friendly touch control makes it inviting to learn and easy to operate. For optimum results:

• Read your guide in the order written.

• Read it while sitting at the instrument.

• Practice using the HFA II by first testing staff members before using it with patients.

Model differentiation This guide contains instructions for Models 720i, 740i, 745i and 750i. Although much of the

information is relevant to all models, some information only applies to particular models.

When a feature or function applies to specific models, this guide specifies the model number(s), often in parentheses, in a prominent location. An example of this is found in the previous discussion of Blue-Yellow testing (previous page). Conversely, model numbers are not specified when information is standard or optional on all models.

You can find the model number of your instrument on the rear panel of the HFA II or you may access this information via the “i ” button located in the upper, left-hand corner of the screen (see Section 2: “The Information “i ” Button”). If you are unsure about the particular capabilities of your instrument, refer to Appendix A: “HFA II Product Specifications”.

Text conventions The terms “select,” “choose,” and “press” are used interchangeably. Each term means to

initiate an operator action using the touch screen, external keyboard, trackball, or mouse. The terms “hard disk” and “hard drive” are used interchangeably in reference to the data storage device standard on all HFA II models.

UPPER CASE LETTERS are reserved for references to specific command buttons found on the touch screen. The exceptions to this are messages on test printouts, the words STATPAC, SITA, SWAP, HFA II, and headings.

Italicized words are used to identify the icon buttons on the right border of the screen, the titles of figures, pictures, tables, and special notes in this manual.

Bold words are used to highlight warnings and section headings.

Additional references The User Guide cannot possibly cover every situation you may encounter with the HFA II,

especially interpretation questions. Your HFA II comes with a copy of The Field Analyzer

Primer which provides an overview of visual field results. Automated Static Perimetry, Second Edition, by Douglas R. Anderson and Vincent Michael Patella (Mosby, Inc., St. Louis),

is recommended for in-depth information and analysis of visual fields.

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SAFETY PRECAUTIONS

The Humphrey Field Analyzer II complies with UL, CSA, EN and IEC safety requirements. Follow all warnings and precautions to ensure the safe installation and operation of the Humphrey Field Analyzer.

CAUTION: This instrument is NOT anesthetic-proof. Do NOT use it in the of a flammable anesthetic since this creates a risk of explosion!

General safety requirements • Although the Humphrey Field Analyzer II is designed for continuous operation, it should

be turned off and covered with the dust cover when not used for an extended period of time. The HFA II should be used in a cool, dry and dust-free setting.

• The HFA II is classified as Type B, class I protection equipment. To prevent electric shock, the instrument must be plugged into an earth grounded outlet.

• Do NOT connect or disconnect cables while power is on.

• Do NOT place any objects on top of the instrument.

• Do NOT place any container holding liquid near the instrument.

• Do NOT place the dust cover on the instrument while the instrument is powered on.

• Do NOT attempt to open the front or rear covers on the HFA II. Only authorized Carl Zeiss Meditec Service personnel should perform repairs on your instrument.

Installation safety • The Humphrey Field Analyzer II is equipped with a three-prong plug. The instrument precautions should be plugged into a correctly wired outlet with a ground receptacle. If the plug

does not fit the outlet, contact an electrician. Do NOT disable or remove the ground pin.

presence

• Do NOT overload your AC outlet.

• If the cord or plug is damaged, do NOT continue to use the instrument. Electrical shock or fire hazard may result. Call Carl Zeiss Meditec Customer Service for replacement.

• Do not block the ventilation openings. These allow for the release of heat generated during operation. A buildup of heat due to blockage can cause failures which may result in a fire hazard.

• Use only a stand or table recommended by Carl Zeiss Meditec.

• If the stand or table has casters, do NOT try to roll it in deep pile carpet or over objects on the floor such as cables and power cords. Lock the casters to secure the table.

• Do NOT place the instrument on an uneven or sloped surface.

• Do NOT use accessories that are not designed for this instrument. Use only those parts recommended by Carl Zeiss Meditec to achieve optimum performance and safety. Accessories must meet UL, CSA, EN, and IEC safety standards.

• Do NOT use the instrument in or near wet or moist environments.

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CAUTION: Always replace fuses with same type or rating. Failure to do so may create a fire risk. Refer to fuse ratings listed on the label on the rear panel of the instrument

or on the table near the fuse holder. See Section 12.

Peripheral Placement NOTE: To maintain patient safety, peripheral devices such as printers must be placed at least Instructions 1.5 meters (4.9 feet) away from the patient, such that the patient cannot touch a peripheral

device with any part of his or her body while being examined. In addition, the instument operator must not attempt to touch the patient and a peripheral device at the same time while examining the patient.

Radio and TV interference The Humphrey Field Analyzer II has passed all domestic and international electromagnetic

emission/suppression standards. However, it still generates small amounts of radio frequency energy and may cause interference to radio, television or other instruments. If the HFA II does cause interference to radio or television reception, the following measures may be necessary:

• Plug the Humphrey Field Analyzer II into a different outlet so that the instrument and the receiving device are on different branch circuits.

• Reorient the HFA II with respect to the TV or the radio antenna.

• Move the receiving device and the HFA II away from each other.

• Use only shielded communication cables.

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Symbol definitions The following symbols appear on the HFA II:

Power On Power Off

Projector Bulb

Air Intake Filter

Serial RS-232 Communication Port

Printer

Floppy Disk Drive

Important Instructions Found in Manual

Uninsulated High Voltage Inside the Instrument Risk of Electric Shock

Type B Class I

Brightness

USB Port

VGA Monitor

Keyboard

Mouse

Network

Fuse

Patient Response Button

Data

Figure 1.3: HFA II Symbol Definitions

Power on The power switch is located on the rear panel of the instrument. The room lights should be

dimmed or off when turning on the HFA II. Once engaged, the HFA II begins performing a selfdiagnostic checkup. In the event the computer detects a problem, a message will appear on the start-up screen. Call Carl Zeiss Meditec Customer Service if necessary.

Should you need to unplug any component from the HFA II, remember to first turn off the power to the HFA II. Disconnection procedures are the opposite of the sequence listed in this Section. Whenever there is a question as to whether the HFA II is running properly or if there is any question about electrical or fire safety: UNPLUG THE INSTRUMENT and call Carl Zeiss Meditec Customer Service as soon as possible: 1-877-486-7473.

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1-12 INTRODUCTION / INSTRUMENT SETUP

SYSTEM COMPONENTS

Touch screen

Chin rest control

Patient response button

Touch screen brightness control

Hard drive

Floppy drive

Magneto-Optical Drive

Figure 1.4: The HFA II – Side View

Location of Model

and Serial Number

Air filter

Power switch Power cord outlet

Cables emerge through

Finger divot for

opening rear

panel

opening here

Figure 1.5: The HFA II – Rear View – See Figure 1.7 for View Without Rear Panel

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INTRODUCTION / INSTRUMENT SETUP 1-13

Forehead rest

Testing bowl

Chin rest

Optional instrument

slider

Blue-Yellow visor handle (model 745i and 750i)

Trial lens holder

Slider handle

Table height switch

Table with mounted Printrex printer

Caster

Lock

Figure 1.6: The HFA II – Front View with Instrument Table

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1-14 INTRODUCTION / INSTRUMENT SETUP

ADDITIONAL COMPONENTS

Many external devices are available to help operate your HFA II. The following is a description of these devices and how to properly attach them to the HFA II.

Printers Several printers are currently supported by the HFA II:

• Printrex Thermal Line Printers Table-Mounted Model (standard with HFA II) Stand-Alone Model (optional)

• Hewlett-Packard LaserJet Printers (optional): 1100 SE, 1200 Series and 3200 SE

• Lexmark Optra E312L Printer

• AeroComm Go Print XL wireless printing accessory

These specific models of the printers were tested for functionality and leakage current requirements. Other printers may also work with the HFA II i series instrument.

Printrex: Table-Mounted and Stand-Alone Model

1. With power off to the table and HFA II, connect the printer interface cable to the Printer

port on the HFA II. Attach the power cord to the special outlet below the table for the tablemounted Printrex printer. Refer to Figures 1.7, 1.8 and 1.9. The power cord for the standalone model plugs into the wall outlet.

2. Insert paper supply. Refer to Section 12: “Loading Paper”.

3. Turn on power to the table. Turn on power to the Printrex printer.

4. Turn on power to the HFA II.

5. From the System Setup screen, select PRINTREX. See Section 2: “Selecting the Printer Type.”

Hewlett-Packard LaserJet

Before you start, check that you have the following supplies:

• HP LaserJet printer • HP printer manual • Printer paper

• Interface cable • Toner cartridge

1. With power off to the HFA II, connect the interface cable to the Printer port on the HFA II

(refer to Figures 1.7 and 1.8) and the printer (refer to Hewlett-Packard printer manual).

2. Install the toner cartridge.

3. Insert paper supply.

4. Connect the printer power cord to the wall outlet.

5. Turn on power to the printer and the HFA II.

6. At the System Setup menu, select HP LASERJET. See Section 2: “Selecting the Printer Type”.

External keyboard The HFA II supports an external keyboard. The keyboard plugs into the back of the HFA II

(refer to Figure 1.7 and 1.8 for the location of the plug).

1. Power off the HFA II (keyboard will not work if connected with power on).

2. Plug in the keyboard.

3. Power on the HFA II.

While many standard PC-type keyboards (must have PS/2-style plug) may be plugged into the HFA II and should work, we can only guarantee compatibility if we shipped a keyboard to you. See Section 2: “Using the External Keyboard” for more details.

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INTRODUCTION / INSTRUMENT SETUP 1-15

Trackball, mouse, It is usually possible to use a Microsoft™-compatible serial trackball, mouse, or other external or other input device input device with your HFA II. These devices may be used as an alternative to pressing the

touch screen. They may be used in conjunction with the optional external keyboard. The keyboard is not necessary to utilize these devices. For simplicity in describing the feature, the term “trackball” will be used to represent any compatible input device. The serial trackball is connected to the Mouse port on the back of the HFA II. The HFA II must be turned off when attaching or removing any input device. See Section 2 for use of the trackball.

External VGA monitor Your HFA II allows you to connect an external VGA monitor. Commands issued with the

keyboard and trackball / mouse can be seen on the external screen. Touch screen capability is not available on the external monitor. The HFA II touch screen remains available for use when using the external monitor. Output to the external monitor will display in black & white, even when using a color monitor. Connection of the VGA monitor is made to the port found on the back of the HFA II. See Figures 1.7 and 1.8. Use the VGA connection.

Surge protectors Carl Zeiss Meditec recommends the use of surge protectors or UPS (Uninterruptable

Power Supply) systems to help isolate the HFA II from power surges or fluctuations. The HFA II is very sensitive to line voltage changes and may experience database problems if subjected to brownouts, power outages or surges of voltage. Hospitals, surgery centers, and offices with instruments which consume large amounts of power, such as lasers, should be especially careful to plug the HFA II directly into a UPS or adequate surge protector. Plugging the power table into the UPS may not be adequate protection. Carl Zeiss Meditec recommends a system with a rating of 450 volt amps or greater.

Connection of External devices connect to the HFA II at the rear of the instrument and are hidden from view external devices behind a panel. Figures 1.7 and 1.8 show the location and identification of many of the

connectors previously mentioned. A diagram next to the panel helps to identify each port.

External input devices such as the glidepad, trackball, mouse and the keyboard need a PS/2 style plug for connection to the HFA II. Use the Data Transfer connection to plug in an HFA I for serial transfer of data. Also use the Data Transfer port for connection of PC-based communications (Ex: Ensemble). Use the VGA for connection of any external VGA monitor.

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1-16 INTRODUCTION / INSTRUMENT SETUP

Network

Data Transfer

Mouse

Printer

Aux.

Keyboard

VGA

Figure 1.7: Rear View of the HFA II with panel removed

USB

Data Transfer

Network

Printer

Unused

Mouse

Aux.

Keyboard

VGA

Figure 1.8: Enlarged view of cable connections panel on rear of HFA II

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INTRODUCTION / INSTRUMENT SETUP 1-17

SYSTEM ASSEMBLY

Open rear panel on back of HFA II.

Connect printer cable to Printrex

printer and HFA II at rear of unit (see

close-up Figure 1.8).

Attach Printrex power cord to

special outlet on underside of

table.

Connect power cord from back

of HFA II to power outlet on

underside of table.

Attach keyboard and glidepad or

trackball / mouse if desired.

Replace rear panel, being careful to run cables out through slot at bottom (see Figure 1.5)

Attach power cord at base of table

and connect to wall outlet.

Turn on power to the

Printrex printer.

Turn on power to the HFA II.

Figure 1.9: The HFA II – Rear View on Instrument Table

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General Operation

General Information 2-2

The Main Menu Screen 2-9

System Setup 2-10

Additional Setup 2-21

Help Screens 2-23

This section covers general operation of the HFA II. It describes how to execute commands, input information, and customize the HFA II to suit your needs.

After reading Section 2 you will be familiar with:

• command buttons and icons on the HFA II screen

• using the Main Menu screen to select tests

• personalizing printouts with the name of your practice

• setting the internal clock and calendar

• customizing the test buttons displayed on Main Menu screen

• using the optional keyboard.

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GENERAL OPERATION

GENERAL INFORMATION

Screen simplicity Almost every screen is divided into three areas: the Title Bar, the Screen Body, and the

Icon Buttons.

Title Bar

Floppy disk drive with padlock

Command

Buttons

Screen Body

Figure 2.1: Main Areas of the HFA II Screen

The Title Bar

This area is the top portion of every screen. The middle of the title bar displays the name of the screen in bold type. The left side shows the system software version and the “i” button. More information about the “i” button appears later in this section. The right side displays the current date, time, and a picture that shows if the floppy disk in the drive is in use. Do not

insert or remove a floppy disk when the padlock is displayed on the screen as shown above.

Operator messages may appear in the top right corner of the Title Bar or the center of the Screen Body to inform you of a condition or alert you to a problem. “Printer is not connected or Off Line” and “Uninitialized Disk” are examples of operator messages. Multiple messages may appear stacked and overlapping in the upper right corner. Touching the top message collapses it, revealing the previous message.

Icon Buttons

The Screen Body

The Screen Body comprises the largest part of every screen. This is where most of the commands are issued via command buttons. The contents of the Screen Body changes after every command. The Screen Body is referred to as the “screen” throughout the User’s Guide.

Frequently, a button will appear dimmed or “ghosted.” This indicates either that the button function cannot be activated from that screen or that the button represents a feature that is not available on the HFA II model being used. For example, the CUSTOM TESTS button on the model 720i HFA II has been ghosted because this option is not available on the model 720i and is, therefore, nonfunctional.

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GENERAL OPERATION

Icon buttons These buttons occupy the right side of most screens. Each has a unique function that can be

accessed at any time unless there is a pop-up window present or the icon buttons are ghosted. See “Pop-up Windows” later in this section for details. The HFA II’s icon buttons are shown below along with a brief description of their function.

MAIN MENU

The MAIN MENU icon allows you to return to the Main Menu screen from other system screens.

HELP

The HELP icon gives brief explanations of certain features and procedures available on the HFA II. You should always consult this Guide for further information.

PATIENT DATA

PATIENT DATA leads you to the Patient Data screen where you may enter or recall the patient’s name, date of birth, I. D. number, trial lens information, and diagnostic data prior to testing. Main Menu test buttons also automatically lead you to the Patient Data screens.

FILE FUNCTIONS

Through FILE FUNCTIONS you can access the patient test results that have been saved as well as perform various database management procedures.

2-3

PRINT FUNCTIONS

PRINT FUNCTIONS allows you to print out hard copies of test results in various formats.

SYSTEM SETUP

SYSTEM SETUP lets you define certain user settings. Examples of these are time and date, printer type, visual acuity format, and practice name and address on printouts. Access to the SYSTEM SETUP icon is only available from the Main Menu screen.

UNDO

The UNDO icon takes you back to the previous screen. In some cases pressing the UNDO icon will appear to take you back two screens. This occurs when the previous screen is a pop-up window. The UNDO icon is not available on the Main Menu screen.

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GENERAL OPERATION

The information The “i ” button is present on most screens and can be found in the upper left corner of the

“i”

button screen. Pressing this button brings you to the Unit Configuration screen which contains

information useful when contacting Humphrey Customer Service. If the video eye monitor is displayed, you will need to turn the monitor OFF to access the “i ” button.

The following information is displayed when the “i ” button is pressed:

Model Number Serial Number Operating System-Revision Number Language Hardware Options Software Options Personalized Information such as user’s name, address, and telephone number.

The Unit Configuration information may be printed by pressing the PRINT button. To return to the previous screen, touch CANCEL.

Figure 2.2: The Unit Configuration Screen.

Touch screen Operating the HFA II is literally at your fingertips. You can perform all functions, whether

entering data or selecting a test, by simply touching a command button on the touch screen.

While using the touch screen, the HFA II is activated when your finger is removed from the button you select. Be careful not to pound or press too hard against the touch screen. A light touch works best. An audible beep will alert you of successful button

activation.

If you have difficulty activating the touch screen, consider re-calibrating it. Details on calibrating the touch screen are found in “Additional Setup” later in this section as well as in Section 12: “Touch Screen Calibration”.

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Pop-up windows Frequently, when you select an option from a screen, a smaller screen opens and is

superimposed over the original screen. This additional screen is called a “pop-up” window. It may provide information or require data input. In either case, only command choices (buttons) appearing within the pop-up window are active at that time. You cannot select an icon button when a pop-up window is open.

Figure 2.3: Example of a Pop-Up Window

2-5

Drop-down menus A “drop-down” menu reveals settings for you to choose from. You can easily identify a drop-

down menu by its characteristic arrow positioned within the command button. The current selection is visible to the left of the arrow. To open the menu and reveal the options, touch the current selection. To change the selection, touch any item on the drop-down menu. The menu will collapse. To keep the original selection, simply touch the top selection.

Examples of HFA II drop-down menus are found on the Screening Parameter Setup screen shown below. A closer look at the Test Speed drop-down menu reveals the two available selections, NORMAL and SLOW.

Figure 2.4: Example of a Drop-Down Menu

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GENERAL OPERATION

Using the external keyboard The external keyboard will operate many of the buttons on the HFA II screen. An outline

(or highlight) surrounding the active button indicates the action to be performed. The example below shows the highlight around the PATIENT NAME button. Pressing the ENTER key or SPACE BAR will activate the highlighted button. The TAB key allows you to move the highlight from button to button in a forward direction. Holding the SHIFT key down while pressing the TAB key will cause the highlight to move in the opposite direction.

The arrow keys, in most cases, can be used to move the highlight from button to button. They mimic the action of the TAB and SHIFT-TAB keys for moving the highlight. Like the TAB key, both the DOWN and RIGHT arrows move the highlight forward. The UP and LEFT arrows reverse the direction of the highlight as the SHIFT-TAB combination does.

The arrow keys will not advance the highlight on screens having drop-down menus (for example, the Parameter Setup and System Setup screens). Instead, use the TAB or SHIFT-TAB keys to move the highlight around the screen. The arrow keys are used to select the choice within the window as described below.

The PAGE DOWN key on the external keyboard must be pressed if you wish to change the setting on a drop-down list with the external keyboard. This applies to all of the fields on the Parameter Setup screens, the drop-down lists at the top of the System Setup screen, and the Disk Options windows. For example, if you wish to change the fixation target from CENTRAL to LARGE DIAMOND by using the external keyboard, you would first use the TAB key to move the highlight to the FIXATION TARGET drop-down menu. Press PAGE DOWN to activate the selection feature. The UP and DOWN arrow keys will scroll the highlight through the choices on the selection menu. Choose the highlighted selection by pressing the ENTER key.

The keyboard may be used to enter patient data. Both upper and lower case letters may be entered with the keyboard. You may find that it is more efficient to use the keyboard in combination with the touch screen, especially for applications such as entering trial lens data.

After data (such as PATIENT NAME) is entered, the highlight will remain around the button just activated. To advance to the next button, you simply press the TAB key.

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2-7

You may also opt to navigate through the system with the help of the keyboard function keys. F1 through F6 serve as keyboard equivalents of the icon buttons. The function keys and the associated icon buttons they activate are listed below:

F1 HELP F2 MAIN MENU F3 PATIENT DATA F4 FILE FUNCTIONS F5 PRINT FUNCTIONS F6 SYSTEM SETUP / UNDO

Using the trackball, mouse, It is possible to use any Microsoft

™

-compatible serial trackball, mouse, or other external

or other input device input device on your HFA II. These devices may be used as an alternative to pressing the

touch screen. They may be used in conjunction with the optional external keyboard, although the keyboard is not necessary to utilize these devices. For simplicity in describing the feature, the term “trackball” will be used to represent any compatible input device. See Section 1: “Optional Components” for directions on connecting the trackball or mouse.

Using a trackball with the HFA II is very similar to using this device with a business or personal computer. Trackballs vary, so experiment with your trackball to determine which button may be used. If using a mouse, only the left-most button is active. Other buttons do not function with the HFA II.

The trackball is used in conjunction with a cursor, which appears as a small, movable square on the video screen of the HFA II. The cursor moves as you move the trackball. Items are selected by moving the cursor to the desired item and pressing (or clicking) the left-most button on the trackball (or appropriate mouse button). To ensure that the appropriate item is selected, make sure that the cursor is completely within the boundary of the desired item.

To select an item on a drop-down menu, move the cursor to the desired drop-down box. Click the trackball button. The drop-down menu will appear. Drag the cursor down to the desired item until that item is highlighted. Press the trackball button again. The drop-down menu will disappear and the selected item will appear in the drop-down box, indicating that it has been selected. This procedure is identical to selecting menu items on many popular computer programs.

Note: The cursor may not always be visible. To locate the cursor, either move the trackball or press a keyboard button. It is not recommended to press the SPACE BAR or RETURN key, as these will activate the highlighted screen button.

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GENERAL OPERATION

File directory

A file directory appears whenever the user wants to perform a specific function with previously saved tests. Buttons such as VIEW TESTS, COPY TESTS, and CHANGE PATIENT DATA will bring up directories. To select specific items on a directory, move the cursor to the desired item. Click the trackball button to highlight this item. If more than one item can be selected, such as with the COPY TESTS feature, a check mark (✓) will appear next to the item to indicate that it has been selected.

Several items in a row can be selected at one time by holding down the trackball button, dragging the cursor to highlight and check (✓) several items, and then letting go of the button. After dragging, only the last item will remain highlighted; however, each item selected will have a check mark next to it.

To deselect a chosen item, move the cursor to a highlighted or checked (✓) item and click the trackball button. The check mark next to the item will disappear.

Screen saver The HFA II features a screen saver to extend the life of the video screen. It activates after the

HFA II has been idle for 10 minutes. The screen saver will disappear when the touch screen is pressed, a key on the external keyboard is pressed, or the trackball is moved.

Figure 2.5: The Screen Saver

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THE MAIN MENU

SCREEN

2-9

When the HFA II is turned on, the first screen displayed, after the start-up sequence, is the Main Menu screen. Its primary functions are to display a series of test buttons (from which you initiate the testing procedure), allow recall of the last test performed, and provide access to the System Setup screen. A further explanation of Main Menu functions follows Figure 2.6 below.

Command buttons

Figure 2.6: The Main Menu Screen

A Test Button

Each test button displays the name of a test. Pressing the test button allows you to choose the eye to be tested. See Section 3: “Using Test Buttons” for more information.

Recall Last Test

This button accesses the results from the last right and left eye tests performed. When the HFA II is first powered on, this button appears ghosted. It will remain inaccessible until a test has been run. The memory is cleared when the instrument is turned off.

Show Test Library

This button leads to a list of all available test patterns, including Screening, Threshold, Specialty, Custom, and Kinetic tests. When you want to select a test not found on the Main Menu screen, choose the SHOW TEST LIBRARY button. See Section 3: “The Test Library” for details.

The Main Menu test buttons may be customized to reflect your needs. Any test in the Test Library may be placed on the Main Menu screen. Buttons which are not used very often may be removed. A second line of text can be added to test buttons to differentiate tests with the same name but having different parameters. See “Altering the Main Menu Screen” for additional information.

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SYSTEM SETUP

GENERAL OPERATION

The System Setup screen is accessed by pressing the SYSTEM SETUP icon located on the Main Menu screen. You may choose from a variety of selections on the two System Setup screens: the main System Setup screen shown in Figure 2.7 and the Additional Setup screen illustrated in Figure 2.8. Your selections will determine the mode in which your HFA II will power-up. An explanation of the System Setup functions and procedures to alter the settings are described on the following pages.

Figure 2.7: The Main System Setup Screen

Language

The HFA II allows you to choose among English, German, Spanish, French, Italian, Japanese, Portuguese, and Swedish languages. If you select a different language from the current language set, the HFA II will automatically reboot in that language. The original language must be re-selected in order to be reactivated.

Head Tracking (model 750i only) When Head Tracking is turned ON, the instrument moves the chin rest during a test to keep the patient’s eye centered behind the trial lens holder. This action helps to reduce trial lens artifacts (test points being blocked from the patient's view by the edge of the trial lens). This feature only works if Gaze Tracking has been successfully initialized and the trial lens holder is in the Up position. For more information see Section 5: “Head Tracking”.

Vertex Monitor (model 750i only) When the Vertex Monitor is turned ON, a beep is sounded and a message is displayed if the patient’s head is too far back from the trial lens during a test. This helps to eliminate the trial lens as a source of visual field defects. This feature only works if Gaze Tracking has been successfully initialized and the trial lens holder is in the Up position. For tips on using this feature, see Section 5: “Vertex Monitor”.

Set Time and Date

This allows you to reset the instrument’s internal clock and calendar in a format appropriate for your geographic region. Accurate date information is critical for correct STATPAC analysis, age-corrected screening tests, and proper trial lens calculations.

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Print System Log

The system log prints the instrument serial number and configuration options along with messages occurring in the HFA II. This feature is designed to be used by Carl Zeiss Meditec field software representatives. Should you experience a problem with your instrument, it is a good idea to print the system log before calling Carl Zeiss Meditec customer service.

Save/Transmit Option

This option allows the user to change the SAVE button functionality on the End of Test screen. Choices are Transmit Only, Save Only, or Save and Transmit. Transmit allows the user to send (transmit) data via a serial interface cable to an outside computer system at the end of every test. Additional transfer methods may be available.

Printer

This option allows you to designate the printer type to be used with your instrument. The choices are HP LaserJet and Printrex. The HFA II supports the following HP LaserJet Models: 1100 SE, 1200 and 3200 SE printers. The Lexmark Optra E312L printer is also supported. These specific models of the printers were tested for functionality and leakage current requirements. Other printers may also work with the HFA II - i series instrument.

Note: It is the owner’s responsibility to ensure that any printer used in a medical environment meets the appropriate medical directives and International Safety Standards.

VA (Visual Acuity) Format

Select 20/20 Snellen, 6/6 Metric, or 1.0 Decimal as the visual acuity format used when entering patient data.

Auto Pupil (model 750i only) If Auto Pupil is set to ON, the HFA II will automatically take a measurement of the patient’s pupil diameter and enter the finding on the Patient Data 2 screen. An asterisk (*) is added whenever the measurement was made automatically. The measured pupil size will also appear on the display screen. Manual pupil measurement input is displayed without an asterisk. The pupil diameter will also appear on the printout. This feature only works if Gaze Tracking has been successfully initialized. For more information on Gaze Tracking, see Section 5: “Gaze Tracking”.

Personalized I.D.

This allows you to customize hard copy printouts with 5 lines of text (e.g. practice name, address, and telephone number).

Alter Main Menu

This allows you to customize the Main Menu screen by adding test buttons which normally are only accessible through the test library, by deleting test buttons which are not often used, or by altering test buttons to power-up with your preferred testing parameters. Additional text may be added to further describe the parameters or usage of customized buttons. See “Altering the Main Menu Screen” for details.

Additional Setup

This allows you to use additional System Setup functions found on the Additional Setup screen.

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GENERAL OPERATION

Accessing the system setup screen

Start at the Main Menu.

Select the SYSTEM SETUP

icon.

Choose the desired

function.

Altering the language

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Start at the System Setup

screen. Select the

language drop-down menu.

Choose from English,

German, Spanish, French, Italian, Japanese, Portuguese, or Swedish. Once a language has been selected, the instrument will restart in order to change parameters.

If a foreign language is selected inadvertently, select the SYSTEM SETUP icon (bottom righthand corner of the Main Menu). When the System Setup menu appears, select the top left-hand drop-down menu and select the first option item to return to English.

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GENERAL OPERATION

2-13

Accessing head tracking (model 750i)

Start at the System Setup screen.

Select the Head Tracking drop-down menu.

Choose between ON and

OFF.

Note: If Head Tracking is turned on during testing and the patient moves, the instrument will adjust the chin rest in small, 0.3 mm increments until the patient returns to the original position. This feature only works if Gaze Tracking has been successfully initialized and the trial lens holder is in the Up position. For additional information, see Section 5: “ Head Tracking”.

Accessing the vertex monitor (model 750i)

Start at the System Setup screen.

Select the Vertex Monitor drop-down menu.

Choose between ON and

OFF.

Note: When the Vertex Monitor is turned on, a beep will sound if the patient has backed away from the trial lens during testing. Although the test will not pause, a message will remain on the screen until cleared by the operator. This feature only works if Gaze Tracking has been successfully initialized and the trial lens holder is in the Up position. For additional information, see Section 5: “Vertex Monitor”.

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GENERAL OPERATION

Setting the time and date

Start at the System Setup screen. Select SET TIME AND DATE.

Select the Time Format

drop-down menu.

Choose 24 HOURS or AM/PM from the drop-down menu.

Press TIME ENTRY. Input the correct time on the keypad, then press ENTER.

Printing the system log

Note: If you have selected AM/PM format, you must enter either AM or PM with the time entry.

Select Date Format. Choose MM-DD-YYYY, DD-MM-YYYY or YYYY-MM-DD from the

drop-down menu.

Note: MM= Month, DD=Day and YYYY=Year.

Select DATE ENTRY. Input the correct date from the keypad, then press ENTER.

Note: The time and date display appears in the upper right-hand corner of the screen in the format determined above.

Start at the System Setup screen. Select PRINT SYSTEM LOG.

The instrument will automatically start to print the System Log.

Note: Length of time to print log will vary depending on system log size.

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Accessing the save/transmit option - serial connection VIA button to toggle between Serial and Network connection settings. Network

Start at the System Setup screen. Select the SAVE / TRANSMIT OPTION. Press the TRANSMIT

connections are described on the next page.

The drop-down menu at

the right allows you to choose from SAVE ONLY, SAVE AND TRANSMIT, or TRANSMIT ONLY.

After choosing SAVE AND

TRANSMIT or TRANSMIT ONLY, press SERIAL TRANSMIT SETTINGS. The Transmit RS-232 Setup screen will appear.

At the Transmit RS-232

screen select the Baud Rate, Parity, Data Bits and Stop Bits as required for transmission.

The following choices are available:

Baud Rate 300, 600, 1200, 2400, 4800, 9600, 19200 Parity none odd even Data Bits 7 8 Stop Bits 1 2

For compatibility with other Carl Zeiss Meditec products (Ensemble, HFA 600 series instruments), transmit serial data using 9600 Baud at Even parity with 7 data bits and 1 stop bit.

Select PROCEED to save the changes or CANCEL to restore the previous values. Press

PROCEED on the first screen to save the settings and return to the System Setup screen.

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GENERAL OPERATION

Accessing the save/transmit option - network connection screen. Select the Save /

Start at the System Setup

Transmit option. Press TRANSMIT VIA to display “Network.” Press NETWORK TRANSMIT SETTINGS.

Selecting any of the

network address buttons will display the keypad. Specify the instrument IP address, the remote host IP address and (destination) port number, the default gateway and the subnet mask. Enter the addresses where appropriate, remembering to include the dots if needed. If an entry is invalid, an alert will be displayed. Press PROCEED when all the addresses have been entered.

Make sure the network

connections are secure

and the proper addressing has been established at the other networked unit. Press TEST NETWORK CONNECTION to verify a connection was made at the destination instrument.

Selecting the printer type

If successful, a message will indicate “A connection was successfully established with the remote host.” If the connection fails, the message will read “Unable to establish connection with the remote host. Verify the instrument and host network setup and try again.”

Start at the System Setup

screen. Select the Printer drop-down menu.

Choose between

HP LASERJET and

PRINTREX.

Note: Choose HP LASERJET if using the optional GoPrint device.

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Selecting a visual acuity format screen. Select the VA

Selecting auto pupil (model 750i only) screen. Select the Auto

Start at the System Setup

Format drop-down menu.

Choose from

20/20 SNELLEN,

6/6 METRIC, or 1.0 DECIMAL.

Start at the System Setup

Pupil drop-down menu.

Personalizing hard copy printouts

Choose between ON and

OFF.

Note: Auto Pupil only works if Gaze Tracking has been initialized. For information on Gaze Tracking, see Section 5: “Gaze Tracking”.

Start at the System Setup screen. Select PERSONALIZED ID.

Select the line button

where you wish to enter

text.

Enter the desired text

(maximum of 40

characters per line).

Repeat steps 2-3 for other

lines.

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GENERAL OPERATION

Altering the Main Menu screen

Start at the System Setup screen. Select ALTER MAIN MENU.

Press ADD/CHANGE

A BUTTON.

Select the button position

where the change is to take

place.

Choose from any test type, including SCREENING, THRESHOLD, SPECIALTY, CUSTOM, and

KINETIC tests. After selecting, the same Test Library screens normally accessed through

the Main Menu screen will appear.

Select the test pattern that you wish to add or change. The Parameter Setup screen will

appear. All test buttons start with standard parameters.

Change the existing parameters to fit your needs. Finalize your choices by pressing

SELECTION COMPLETE.

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GENERAL OPERATION

You may add a second line

of text to the button to differentiate it from other buttons. This line will appear below the name of the test.

If you want to add a second line of text, press YES when prompted. Use the pop-up or external keyboard to type the additional information. The external keyboard allows for the use of lower-case letters.

Examples of identifying remarks are “Blue-Yellow,” “FastPac,” or “Dr. Brown’s Test.” See Section 9: “Configuration Backup and Restore” for an example of a Main Menu screen displaying personalized test buttons with additional text.

Note: The Humphrey test pattern name (Central 24-2, C-40 Screening, etc.) cannot be altered.

2-19

Deleting a button

Repeat this process for each button you wish to change.

Note: Buttons which have not been altered through the Alter Main Menu sequence will continue to use standard testing parameters. Testing parameters which are changed via the CHANGE PARAMETERS button during a particular test revert back to the parameters assigned to that button once that visual field test is completed, unless you select TEST OTHER EYE.

Start at the System Setup screen. Select ALTER MAIN MENU.

Select DELETE A BUTTON.

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Choose the button you

wish to remove.

If you want to delete a

button, press DELETE

when prompted.

GENERAL OPERATION

Deleted buttons will be

marked “Test Position Now Blank” on the Alter Main Menu screen. They will appear blank on the Main Menu screen.

Note: Any test removed from the Main Menu screen can still be accessed through SHOW TEST LIBRARY. Standard parameters will be in effect when using a test from the test library unless CHANGE PARAMETERS is selected before testing is begun.

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GENERAL OPERATION

2-21

Adding text to an There is no direct method for adding text to an existing button without going through the existing button “Altering the Main Menu Screen” sequence described previously. Be sure to note the test type

and parameters used on the existing button before selecting ADD/CHANGE A BUTTON. Designate the same test along with the same testing parameters. When the “Do you want to add text to this button?” dialog box appears, press YES.

ADDITIONAL SETUP

The Additional Setup screen is accessed by pressing the ADDITIONAL SETUP button located on the lower right of the System Setup screen. Brief descriptions of the functions available on this screen are cited below.

Figure 2.8: Additional Setup Screen

Simulation

This button is used to demonstrate and verify software function. Press the button to change between ON and OFF. If a test runs while simulation is ON, sample threshold data will appear on the screen in a matter of seconds. Turn simulation OFF before running any tests on patients. Simulation automatically turns OFF when the instrument is powered off.

Switch Beep

The patient response button is designed to give audio feedback every time the button is pressed. Press the SWITCH BEEP button to change between ON and OFF.

SWITCH BEEP may be

turned OFF prior to a test by pressing this button.

Touch Screen Calibration

Occasionally, pressing the touch screen will activate the button next to the one you intended to press. The touch screen alignment can be reset by pressing this button and following the instructions on the screen. See Section 12: “Touch Screen Calibration”.

Custom Test

This button brings you the Custom Test Options pop-up window. It allows you to create or delete a Custom test pattern. For more information see Section 10: “Custom Testing” for more details.

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2-22

GENERAL OPERATION

Backup Configuration

You may save your customized Main Menu buttons (created with the “Altering the Main Menu” feature) and Custom test patterns on a floppy disk. This function protects the information

case of a hard disk problem. See Section 9: “To Backup Configurations”.

Restore Configuration

This function allows you to restore the information that was saved using the BACKUP CONFIGURATION button.

See Section 9: “To Restore Configurations” for details.

Caution: Restoring from a floppy disk will change the original Main Menu configuration. It also replaces all custom tests in the Custom and Kinetic test libraries.

Cleanup Hard Disk Database

This feature deletes files containing patient data with no associated test data. This can occur when patient data is entered, but the test is not saved. This can also happen when patient data is entered early in the day for convenience, but the patient does not take the visual field test. Pressing the CLEANUP HARD DISK DATABASE button will remove all the “unassociated” data from the database. See Section 9: “Cleanup Hard Disk Database” to utilize this feature.

Rebuild Hard Disk Database

The rebuild function is used in the event of a database failure. Rebuilding the patient database may take several hours to complete, depending upon the number of files present. It is best to perform this function at the end of a day or over a weekend. See Section 9: “Rebuild Hard Disk Database” for more information.

Rebuild Floppy Database

This allows the user to rebuild the database on a floppy disk. A full floppy disk may take several minutes to rebuild. See Section 9: “Rebuild Floppy Disk Database” for details.

Install Software

This feature allows supplemental software to be loaded on the HFA II without requiring the instrument to be turned off and on (rebooted). See the Appendix: “Installing New HFA II Software” for details.

Diagnostics

This feature is only accessed by Carl Zeiss Meditec Engineers. It leads to a variety of tests used for system calibration and repair.

Return to System Setup

This button returns you to the main System Setup screen.

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GENERAL OPERATION

HELP SCREENS

2-23

The HFA II is equipped with help screens to assist you with a number of topics concerning the instrument’s operation. The HELP icon may be pressed at almost any time to access the onscreen Help menu. The HELP icon is not available when a pop-up window is displayed. You must complete the action within the pop-up window or cancel the action to access the Help menu. When pressing the HELP icon, the following Help Topics screen is displayed:

Figure 2.9: Help Topics Screen

Make your selection from a list of 12 topics. Topics that require more than one screen of information will have buttons at the bottom of the screen for advancing to the next screen (or for returning to the previous screen).

Each topic displayed may be printed by pressing the PRINT button at the bottom of the Help screen. The entire text of the subject being viewed will be printed. Topics requiring more than one screen, such as “Printing Test Results”, will have the complete text printed, not just the screen being viewed.

Figure 2.10: Example of a Help Screen

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GENERAL OPERATION

When you have finished with the help topic, press RETURN to return to the Help Topics screen. Pressing DONE on the Help Topics screen will return you to the screen where you first pressed the HELP icon. For example, if you were at the “End of Test” screen when you originally pressed the HELP icon, you will return to the same “End of Test” screen when you press DONE on the Help Topics screen.

Consult the User’s Guide for additional information on the subject of interest. The following is the list of on-screen Help topics and the main areas within this User’s Guide to find additional information:

• Entering Patient Data – Section 3

• Getting Ready to Test – Section 3

• Patient Instructions – Section 3

• Trial Lens Selection – Section 3

• Changing Parameters – Section 4

• Using Gaze Tracking – Section 5

• Saving Test Results – Section 5

• Printing Test Results – Section 7

• Recalling Patient Data – Section 3

• Head Tracking/Vertex Monitor – Section 5

• Database Help – Section 9

• Routine Maintenance – Section 12

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Setting-Up Tests

Selecting the Test Pattern and Test Eye 3-2

Entering Patient Data 3-8

Using Trial Lenses 3-19

Preparing the Patient 3-22

Pre-test activities are broken down into the steps listed above. This section covers each step in detail so that you can perform them all competently and efficiently.

Also included:

• a complete listing of available tests and their applications

• the proper use of trial lenses

• patient testing instructions

• hints on positioning the patient comfortably.

ChecklistChecklist

Checklist

ChecklistChecklist

Selecting the test pattern

and test eye

✔

Entering patient data

✔

Using trial lenses

✔

Preparing the patient

✔

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3-2 SETTING-UP TESTS

SELECTING THE TEST PATTERN AND TEST EYE

The Main Menu screen is the starting point for performing all tests. From here tests are selected using one of two methods:

• Using test buttons.

• Using the test library.

For details on each test, see “The Test Library”. After a test is chosen, the user enters patient data, as described in “Entering Patient Data” later in this section.

Test Buttons

Test Library

Figure 3.1: Selecting Tests from the Main Menu Screen

Using test buttons Using Test Buttons is the most convenient method of selecting tests. Your new HFA II has test

buttons that are preset with the most commonly used tests. They can be changed, however, to suit your clinical needs. See Section 2: “Altering the Main Menu Screen”.

From the Main Menu

screen, choose a test

by pressing the test button.

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Select the test eye. Choose

RIGHT or LEFT to proceed, or CANCEL to go back to the Main Menu screen.

Refer to “Entering Patient Data,” later in this section, to continue test setup.

Using the test library Use this method to select a test that does not appear on one of the test buttons.

From the Main Menu

screen, choose SHOW TEST

LIBRARY.

Select the test type. Choose

from KINETIC, SCREENING, CUSTOM, THRESHOLD, or SPECIALTY.

In this example, SCREENING is chosen.

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Select the test pattern.

Choose from among several

test patterns.

Refer to “Test Library” below for information on each pattern.

Select the test eye. Choose

RIGHT or LEFT to proceed, or CANCEL to go back to the test library.

Refer to “Entering Patient Data,” later in this section, to continue test setup.

Test library The HFA II offers a variety of screening and threshold test patterns that meet most clinical

needs. Tables 3.1, 3.2, and 3.3 describe each pattern in order to assist the professional in choosing the one best suited to the patient’s needs. Appendix E contains diagrams of the available test patterns.

Screening tests serve an important clinical function by quickly surveying the visual field and flagging areas that are highly suspect. They answer the question, “Is there a problem?”. Abnormal test results warrant further investigation with threshold testing. See Table 3.1 for details about the available Screening tests.

Threshold tests more precisely define the problem by calculating the actual sensitivity level at each test point. They uncover early depressions and subtle changes in retinal sensitivity. See Table 3.2 for details about the various Threshold tests.

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Specialty tests are specially designed screening tests for specific purposes. See Table 3.3 for details about the Specialty tests.

Models 740i, 745i and 750i allow you to create and store your own Custom test patterns. In addition, the HFA II model 750i offers Kinetic testing (optional on 745i and 740i). See Section 10 (Custom) and Section 11 (Kinetic) for more information these testing options.

Table 3.1: The Screening Test Library

Screening Test Extent of Visual Application Library Field Tested/Number

of Points Tested

Central 40 30 degrees/40 points General screening

Central 64* 30 degrees/64 points General, glaucoma,

neurological

Central 76 30 degrees/76 points General, glaucoma,

neurological

Central 80 30 degrees/ 80 points General Screening

Central Armaly* 30 degrees/84 points Glaucoma

Peripheral 60 30 to 60 degrees/ General, neurological with

60 points central exam, retinal,

glaucoma

Nasal Step* 50 degrees/14 points Glaucoma

Armaly Full Field* 50 degrees/98 points Glaucoma

Full Field 81 55 degrees/81 points General, retinal, glaucoma,

neurological

Full Field 120 55 degrees/120 points General, retinal, glaucoma,

neurological

Full Field 135 87 degrees/135 points Full Field Screening,

87 degrees temporally

Full Field 246* 60 degrees/246 points Full Field Screening

* not available on model 720i

Note: Test point patterns are illustrated in Appendix E.

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Table 3.2: The Threshold Test Library

Threshold Test Extent of Visual Field Application Library Tested/Number of

Points Tested

10-2 10 degrees/68 point grid Macula, retinal, neurological,

advanced glaucoma

24-2 24 degrees/54 point grid Glaucoma, general, neurological

30-2 30 degrees/76 point grid Glaucoma, retinal, neurological,

general

60-4 30 to 60 degrees/60 points Retinal, glaucoma

Nasal Step* 50 degrees/14 points Glaucoma

Macula 5 degrees/16 points, Macula

2 degree spacing

* not available on Model 720i

Table 3.3: The Specialty Test Library

Specialty Test Extent of Visual Field Application Library Tested/Number of

Points Tested

Esterman Monocular 75 degrees temporal Functional disability

60 degrees nasal/100 points

Esterman Binocular 150 degrees bitemporal/ Functional disability

120 points

Superior 36** 60 degrees, superior Superior Field Screening

hemifield/36 points

Superior 64** 60 degrees, superior Superior Field Screening

hemifield/64 points

** uses the Bottom LED fixation target.

Note: Test point patterns are illustrated in Appendix E.

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SETTING-UP TESTS 3-7

Test library notes There are a number of different uses for the tests included with your HFA II. Some have special

settings or conditions that are important to understand to correctly perform the test.

• The Bottom LED fixation target is automatically used by the HFA II in order to test all points of the Superior 36 or Superior 64 point Screening Test. Remember to direct the patient’s fixation to this lower target. If you manually set the Central target to be used with either Superior Field test, some of the most superior points will be omitted from the test pattern. These tests should be run in the Single Intensity mode with the stimulus set to 10 dB. If you use these tests often, refer to “Altering the Main Menu screen” in Section 2 for information on how to put the test on the Main Menu with the 10 dB stimulus permanently set.

• The Full Field 135 Screening Test will not display all tested points on the screen. However, all points will be tested and may be viewed on the printout.

• To better view the central portion of any completed Full Field test, use the ZOOM button located on the End of Test or View Test screen.

• Any Full Field test whose central 30 degrees have been tested, may be saved, printed and later recalled from disk without completing the peripheral portion of the test.

• The Central 76 point test grid is identical to that of the 30-2 Central threshold test. This allows the practitioner to follow up screening tests with threshold testing at the same points. Similarly, the Peripheral 60 screening test has the same test pattern as the 60-4 threshold test.

Esterman functional tests

• The Macula Threshold Test will test all 16 points twice if the Fluctuation feature is turned ON. If it is turned OFF, the Macula Threshold Test will determine the threshold once. With Fluctuation OFF, the instrument will determine the macular threshold twice only if there is a discrepancy with expected values. The Fluctuation function may be accessed through the Change Parameters menu screen. See Section 6: “Fluctuation Values” or Section 7: “Global Indices” for further information.

Much like the Snellen scale for central acuity, the Esterman scale is especially useful for evaluating visual capability or disability in industry, law, and government (workers’ compensation, motor vehicle, aviation, military). The Esterman test is listed as an option for many disability screenings. Carl Zeiss Meditec is grateful to the American Academy of Ophthalmology for providing the rights to offer the Esterman test for your use.

The Esterman test scores are based on a relative value scale, which is divided into unequal units of 100 for monocular tests and 120 for binocular tests. Each unit is equated to one test point and is given a value of 1% in the monocular field and .83% in the binocular field. The inequality in the size and distribution of the units, with greater unit density in more important areas, makes the scale functional. The HFA II yields the functional score automatically as a percentage and prints it in the lower corner of the printout.

Monocular tests incorporate 100 points and extend 75 degrees temporally and 60 degrees nasally. Binocular tests incorporate 120 points and extend 150 degrees bitemporally. Each stimulus duration is 400 milliseconds with a single intensity Goldmann stimulus of III 4 E (10 dB). These settings have been standardized by international agreement and may not be altered by the user. You may only change the test speed. Testing instructions are provided in Section 5.

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3-8 SETTING-UP TESTS

ENTERING PATIENT DATA

Once you have selected the test and test eye, you will be ready to input patient data. You can input a variety of information about your patient each time he or she takes a visual field test. You need not enter all information requested; however, always enter a name and date of birth since they are required for trial lens calculations, data analysis, and saving the test to the hard drive or to floppy disk.

The patient data section is divided into two main screens: Patient Data 1 displays demographic and trial lens information; Patient Data 2 displays diagnostic information.

Inputting patient ID, patient name, date of birth, screen, choose PATIENT ID. & comments

From the Patient Data 1

This Patient ID option allows the user to create a custom method of cataloging patients.

Input up to 11 characters

from the pop-up keyboard.

Press ENTER.

You will automatically be returned to the Patient Data 1 screen.

From the Patient Data 1 screen, choose PATIENT NAME.

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SETTING-UP TESTS 3-9

Input up to 23 characters

from the pop-up keyboard.

Press ENTER.

Note: The HFA II will recognize two tests as belonging to the same patient as long as the first and last names have identical spelling and the dates of birth match. The addition of spaces and/or commas to the names, even if different between entries, does not prevent the HFA II from recognizing these names as identical.

For example, these entries are all handled the same way:

“Kennedy, Robin” is the same as “Kennedy, Robin” or “Kennedy Robin”.

Choose DATE OF BIRTH.

Input the Month, Day,

and Year from the pop-up keypad, including dashes (-) between entries.

You may enter the year as either two digits or all 4 numbers. The year will be displayed in the 4 digit format.

Press ENTER.

Note: September 22, 1943 should be entered as 9-22-43. The patient is assumed to be less than 100 years old if you enter the year as a two digit number.

Choose RIGHT EYE COMMENTS.

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3-10 SETTING-UP TESTS

Input up to 2 lines of

text from the keyboard.

Press ENTER.

Repeat Steps 7-8 for LEFT EYE COMMENTS. Comments appear on the test results printout.

Note: Comments may be entered before testing or after test is completed. If adding comments after a test is completed, be sure to save the test results so the new comments will be saved.

Inputting trial lens data Many people with a refractive error will need to use trial lenses in order to accurately perform

central field tests or the central portion of Full Field tests. The HFA II will automatically calculate the proper trial lens prescriptions for the patient, or you can manually input any other trial lens selection. For whichever method chosen, the trial lens data will be stored on the Patient Data 1 screen.

Refer to the appropriate section below:

• Automatic Trial Lens Calculation

• Manual Trial Lens Input

AUTOMATIC TRIAL LENS CALCULATION:

From the Patient Data 1

screen, select TRIAL LENS.

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Choose CALCULATE

TRIAL LENS.

For the right eye, select

SPHERE.

If you have not entered the patient’s date of birth, enter it at this screen by pressing DATE OF BIRTH. The trial lens cannot be calculated without this patient information.

Input the patient’s distance

sphere correction. Always remember to enter a plus (+) or minus (-) as the first character. Press ENTER.

If the patient has no sphere correction (plano), you must enter zero (0) for the proper trial lens calculation to be made.

Enter correction for cylinder and axis, if needed.

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3-12 SETTING-UP TESTS

Repeat Steps 4-5 for the

left eye.

Note: SPHERE, CYLINDER, and AXIS may be chosen in any sequence. To correct entries, reselect the command button and then enter the correct data.

Select CALCULATE TRIAL LENS.

The trial lens data is

automatically entered on the

Patient Data 1 screen.

FOR MANUAL TRIAL LENS INPUT:

1. From the Patient Data 1 screen, select TRIAL LENS.

2. Choose MANUAL TRIAL LENS INPUT.

3. Repeat Steps 3-6 above.

4. Choose ENTRY COMPLETE. The manually entered trial lens data is automatically entered on

Patient Data 1.

Note: For guidelines on selecting the proper trial lens (for manual input), refer to “Using Trial Lenses” and Table 3.4.

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SETTING-UP TESTS 3-13

Clearing patient data Often you will want to enter information for a new patient on a blank Patient Data screen.

To remove all information on the Patient Data 1 and Patient Data 2 screens, use CLEAR PATIENT DATA.

From the Patient Data 1 screen, choose CLEAR PATIENT DATA.

Read the confirmation

question and answer

appropriately.

Note: Clearing Patient Data only deletes information from the screen. It does not delete information from the database if the patient data was previously saved.

Recalling patient data When patients return for follow-up testing, you save time and ensure consistency by recalling

previously entered patient data from stored files.

From the Patient Data 1 screen, choose RECALL PATIENT DATA to automatically transfer

patient information from memory to the patient data screen(s).

Select the Source

(HARD DRIVE or FLOPPY).

Choose PROCEED.

The keyboard appears. Type

a few letters of the name you wish to find.

Press ENTER.

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Choose the patient file

you want to retrieve. Use scroll arrow buttons, if necessary, to locate the file (see below). Press PROCEED.

If you see two files that belong to the same patient and you wish to combine them, you may use the MERGE PATIENTS button. See Section 8: “Merging Patient Files” for details.

The “Page Up Arrow” scrolls up a full screen of patients.

The “One Up Arrow” scrolls up one patient.

The “One Down Arrow” scrolls down one patient.

The “Page Down Arrow” scrolls down a full screen of patients.

To quickly locate a patient’s test, access the PATIENT SEARCH button below the File Directory box. Enter the patient’s name in the ENTER NAME TO FIND screen and press PROCEED. The HFA II will search the database for that patient’s tests. If the name cannot be found, the name which follows alphabetically will appear. The PATIENT SEARCH command regards names with multiple spaces or different punctuation as identical.

Edit patient information,

as necessary.

Choose MORE PATIENT DATA to verify, change or add data on the Patient Data 2 screen.

Choose PROCEED to go to the test screen.

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SETTING-UP TESTS 3-15

Patient data 2 screen The Patient Data 2 screen contains diagnostic data fields. When using the external keyboard to

enter data, press the TAB key to move to the next data field. The values entered for visual acuity and pupil diameter will also appear on the printout with the test results.

Figure 3.2: The Patient Data 2 Screen

Inputting diagnostic and procedure codes

From the Patient Data 2 screen, choose DIAGNOSTIC CODE.

Input up to 14 characters

from the pop-up keyboard,

then ENTER.

Repeat Steps 1-2 for the other eye.

From the Patient Data 2 screen, choose PROCEDURE CODE.

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Enter up to 14 charac-

ters from the pop-up

keyboard, then ENTER.

Repeat Steps 4-5 for the other eye.

Inputting pupil diameter and visual acuity

From the Patient Data 2 screen, choose PUPIL DIAMETER.

Enter up to 4

characters (0-14.5; decimal point counts as one character) from the pop-up keypad, then ENTER.

Repeat Steps 1-2 for the other eye. The pupil diameter value will also appear on the

printout.

Note: If the Autopupil feature (model 750i only) is being used, you need not enter a pupil diameter. The automatic pupil measurement will be entered and noted with an asterisk (*) on the Patient Data 2 screen. Gaze Tracking must be initialized for Autopupil to work.

From the Patient Data 2 screen, choose VISUAL ACUITY.

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SETTING-UP TESTS 3-17

Select the appropriate

acuity level from the

pop-up menu.

Press ENTER.

Repeat Steps 4-5 for the other eye. The visual acuity measurement will also appear on the

printout.

Inputting intraocular pressure (IOP)

From the Patient Data 2 screen, choose IOP (intraocular pressure).

Enter up to 2 characters

(0-75) from the pop-up

keypad, then ENTER.

Repeat Steps 1-2 for the other eye.

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Entering Cup/Disk (C/D) ratios

From the Patient Data 2 screen, choose HORIZONTAL C/D (cup/disk ratio).

Enter a decimal point

and up to 2 characters (.00-.99) from the pop-up keypad, then ENTER.

Repeat for the other eye.

Repeat Steps 1-3 to enter a VERTICAL C/D.

When you have finished entering data on the Patient Data 2 screen and are ready to test, choose PROCEED. This takes you to the test screen where you can set test parameters, if desired, before beginning the test (see Section 4).

Here is an example of a Patient Data 2 screen with a number of completed data fields. Remember, completing every field is not required for each patient. Refer to “Entering Patient Data”.

Figure 3.3: A Completed Patient Data 2 Screen

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SETTING-UP TESTS 3-19

USING TRIAL LENSES

All patients requiring near vision correction should use trial lenses while taking central field tests and the central portion of full field tests. For your convenience, the HFA II automati-

cally calculates the proper trial lens for your patient, if you know the patient’s distance prescription and date of birth (refer to “Entering Patient Data” earlier in this section).

If you are not using the automatic trial lens calculation, refer to the following guidelines for selecting trial lenses.

GUIDELINES FOR TRIAL LENS SELECTION:

1. Ignore cylinders of 0.25 D or less.

2. For cylinder errors up to 1.25 D use the spherical equivalent. Use the full

cylinder correction for cylinder errors of 1.50 D or more.

3. Refer to Table 3.4 to determine the spherical power to be used.

Table 3.4: Spherical Trial Lens Correction for Central Visual Field Testing

Distance Distance Distance Distance Distance Distance Distance Distance Distance

Rx Greater Rx Equals Rx is: Rx is: Rx is: Rx is: Rx is: Rx is: Rx is: than Zero Zero (Plano) -0.50 -1.00 -1.50 -2.00 -2.50 -3.00 > -3.00

Age Spherical Trial Lens to Be Used

Use Hyperopic Myopic

Under 30 Distance Rx ••••••• Dist. Rx + 3.25

30 to 39 Dist. Rx + 1.00 +1.00 +0.50 ••••• Dist. Rx + 3.25

40 to 44 Dist. Rx + 1.50 +1.50 +1.00 +0.50 •••• Dist. Rx + 3.25

45 to 49 Dist. Rx + 2.00 +2.00 +1.50 +1.00 +0.50 • • • Dist. Rx + 3.25

50 to 54 Dist. Rx + 2.50 +2.50 +2.00 +1.50 +1.00 +0.50 • • Dist. Rx + 3.25

55 to 59 Dist. Rx + 3.00 +3.00 +2.50 +2.00 +1.50 +1.00 +0.50 • Dist. Rx + 3.25

60 and over Dist. Rx + 3.25 +3.25 +2.75 +2.25 +1.75 +1.25 +0.75 • Dist. Rx + 3.25

• means no spherical trial lens needed

The following are examples of trial lens corrections using Table 3.4:

Example A.

For an emmetropic (plano) 70 year-old patient, follow the Distance Rx Equals Zero (Plano) column to the 60 & Over row. The trial lens correction for this patient is +3.25 D.

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Example B.

For the 61 year-old patient with a distance refraction of +1.50 +0.50 X 60, first calculate the spherical equivalent (+1.75). Then follow the Distance Rx Greater than Zero column to the 60 & Over row where you are instructed to add +3.25 to the distance Rx of +1.75. The trial lens correction for this patient is +5.00 D.

Example C.

For the 35 year-old patient with a distance refraction of +2.00 +1.50 X 90, use a +1.50 D cylinder lens and rotate the axis to 90 in the trial lens holder. Follow the Distance Rx Greater than Zero column to the 30-39 row where you are instructed to add +1.00 to the distance Rx of +2.00. The trial lens correction for this patient is +3.00 +1.50 X 90.

Example D.

For the 30 year-old patient with a distance refraction of -3.00 +0.25 X 90, the 0.25 cylinder is ignored. Follow the -3.00 column to the Age 30-39 row. The • signifies that this patient does not need a trial lens correction, as the bowl will be in focus with no correction whatsoever.

Example E.

For the 63 year-old patient with a distance refraction of -3.00 +2.00 X 75, use a +2.00 cylinder lens and rotate the axis to 75 in the trial lens holder. Follow the -3.00 sphere column to the 60 & Over row. The • indicates that the patient does not require a spherical correction. Use only the cylinder trial lens correction.

Example F.

A 25 year-old patient with a distance refraction of -4.00. Follow the > -3.00 column to the Under 30 row where you are instructed to add +3.25 to the distance Rx. The correct trial lens is -0.75.

Remember, you only need to use a trial lens when testing the central part of the patient’s visual field. The trial lens must be removed for the peripheral portion of any Full Field test. A trial lens is not used for either Superior Field screening test or any Peripheral threshold or screening test.

Note: If your patient is aphakic or needs a high refractive power such as +8.00 D, contact lenses may provide the best visual field testing conditions.

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SETTING-UP TESTS 3-21

Inserting trial lenses into the holder into an upright position

Move the trial lens holder

from its storage position in the bottom of the bowl.

Place the cylinder lens in the

slot farthest away from the

patient and align the axis.

Place the sphere lens in

the slot closest to the patient.

Note: Use only the narrowrimmed type of trial lenses. The wide-rimmed variety will interfere with the patient’s peripheral vision and affect test results. It is helpful to move the lens handle towards the patient’s temporal side so it does not interfere with the patient’s eye brow or nose.

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PREPARING THE PATIENT

Patient instructions for Explain the test procedure clearly and completely. Answer all patient questions before starting. static testing Use the following patient instructions as a guide, but remember to tailor your instructions to

How well your patient understands the test procedure and how comfortable he or she is while taking the test directly influence the reliability of the test results.

the patient’s individual needs.

“This test will measure your central and side vision. It is important that you always look straight ahead at the steady yellow light (Point to yellow fixation light). Other lights will flash one at a time off to the side. Some will be bright, some dim. Press the button whenever you see one of these lights (Give patient the response button). You are not expected to see all of them.” (For threshold tests: “The test is designed so that you may see fewer than half of them.”)

“If you want to rest, hold down on the button (demonstrate to patient). The test will resume when you release the button. We test one eye at a time. Blink normally so your eye does not get dry. A good time to blink is whenever you push the response button.”

Note: Instructions for Kinetic Testing differ slightly. See Section 11 for details.

Occluding the Position the eye patch over the non-test non-test eye eye so that it completely blocks vision, as

shown in the illustration. Make sure nothing interferes with the vision of the test eye. For example, if the patch is secured with an elastic band, position the band above the eyebrow of the test eye as shown.

Seating the patient To increase test reliability, take all steps

necessary to ensure patient comfort:

• Adjust the table height.

• Adjust the seat height.

• Slide the instrument towards the patient.

• Check that the patient is relaxed and holding the response button.

Dimming the room lights Testing with the HFA II should be performed in a dimly lit room. Enough light should be

present for the safety of the user and patient. Any light present during testing should be directed away from the patient and the HFA II bowl opening. Positioning the HFA II away from light sources is suggested. Light from doorways or external light sources should be avoided. Should the room lighting be very bright, the HFA II will post a warning and not allow testing to continue without the lights being lowered.

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SETTING-UP TESTS 3-23

Positioning the patient To facilitate patient positioning, the chin rest is divided into two cups, one designated for at the instrument right eye testing the other for left eye testing.

Place patient’s chin here when

testing the right eye

Instruct the patient to

place his or her chin on the appropriate side of the chin rest, then assist with bringing the forehead against the forehead rest.

Adjust the table height to be as high as necessary to keep the patient sitting comfortably erect, rather than bent over or leaning forward.

If available, pull the slider handle out to release the slider. Slide the HFA II toward the patient to allow improved posture for the test. Release the handle to lock the slider in place.

Place patient’s chin here when testing the left eye

Align the patient on

the video eye monitor so that the pupil is centered in the target. Press the chin rest control in the direction you want the patient’s eye to move in the video eye monitor.

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3-24 SETTING-UP TESTS

Move the trial lens as

close to the patient’s eye as possible without touching the lashes.

If you are running a BlueYellow test, the visor beneath the forehead rest must be extended. You should also allow the patient to adapt to the yellow bowl for about 3 minutes before testing. See Section 4: Blue-Yellow Testing” for details.

Review the patient’s

position in the video eye monitor. The cross (+) should be in the center of the pupil. Adjust as necessary.

When the patient has been properly instructed and comfortably positioned, you are ready to begin testing.

No trial lenses for Esterman This test is used to assess the level of a patient’s functional visual disability. The Esterman monocular/binocular tests tests are designed to be done using a patient’s everyday correction. If the patient does not

require glasses to function normally, perform the test without correction. If the patient does wear glasses to function normally, perform the monocular or binocular test using the patient’s glasses. Do not use trial lenses. You still must use the eye patch when testing with the Monocular version of the Esterman test. Testing instructions are provided in Section 5.

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Test Parameters and Strategies

Setting Test Parameters 4-2

Test Strategies 4-4

SITA™ Testing 4-10

Blue-Yellow (SWAP) Perimetry 4-11

Alternate Color Testing 4-16

Your Humphrey Field Analyzer II has a number of options for using different parameters and testing strategies. The first part of this section discusses standard and non-standard testing parameters as well as the procedure to modify the parameters for specific patients.

The second portion of this section discusses Blue-Yellow perimetry or SWAP (Short-Wavelength Automated Perimetry) and SITA (Swedish Interactive Thresholding Algorithm), two testing methods developed by Carl Zeiss Meditec in cooperation with leading authorities.

This section answers these and other questions:

• What test parameters can I change during the test?

• Can I slow down the test for an elderly patient?

• What are SWAP and SITA?

• Why is the Size V stimulus used for Blue-Yellow testing?

• When can the SITA testing strategy be used?

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4-2 TEST PARAMETERS AND STRATEGIES

SETTING TEST PARAMETERS

Test parameters are the testing conditions used during a test, e.g. stimulus size, test strategy, test speed, etc. While the majority of patients are best examined using “standard” parameters (or default parameters), you can alter the parameter settings for purposes of tailoring the test to meet particular patient needs.

An example of a test parameter is the fixation target which has four settings: central, small diamond, large diamond, and bottom LED. The central fixation light is the default target. It is suitable for most patients, but you can change it if the patient requires a larger target.

Figure 4.1: The Screening Test Parameter Setup Screen

To change test parameters You can access the parameter setup screens two ways:

• From the Start Test screen via CHANGE PARAMETERS.

• From the Test in Progress and Pause screens; during testing only test speed and fixation monitoring can be changed.

Start at the Parameter

Setup screen (Screening or Threshold). Select the parameter you wish to change.

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TEST PARAMETERS AND STRATEGIES 4-3

Select the parameter

setting. The current

setting is highlighted.

Repeat steps 1-2 for other parameters, then press SELECTION COMPLETE.

Standard parameters One setting for each parameter has been designated as the “standard” setting. It is

distinguished from the others by the appearance of an asterisk (*) on the parameter button. If you want to return all settings to the standard mode, select RESET TO STANDARD.

Note: For the purpose of valid comparison, it is important to keep test parameters consistent among different test visits for the same patient. This will maintain proper comparability when evaluating test results from many visits. Other than test speed and fixation monitoring, test parameters cannot be changed once testing has begun.

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4-4 TEST PARAMETERS AND STRATEGIES

TEST STRATEGIES

One of the most important test parameter settings is strategy. For both screening and threshold testing, the strategy can affect the total test time and the precision to which the measurements are made. The strategy also dictates whether screening test results are displayed as qualitative (symbols) or quantitative (decibels) information. All threshold strategies yield quantitative results. Each measures the threshold at every test point. They differ only in the method used. Refer to Tables 4.1 and 4.2 for a more detailed explanation of screening and threshold parameters, respectively.

Table 4.1: Screening Test Parameters

(Standard parameter settings appear in bold print)

Screening Parameter Description Parameters Settings

Test Strategy Two Zone For each point in the test pattern, a stimulus is

presented 6 dB brighter than the expected hill of vision. Printouts display circles (O) for seen stimuli and boxes ( is done with an intensity 6 dB brighter than the expected threshold, missed points are known to be at least 6 dB deep.

■) for missed stimuli. Since screening

Three Zone Same as Two Zone, except each missed point is

measured again at maximum intensity of 10,000 apostilbs (0 decibels) to determine if the defect is absolute. Printouts display circles (O) for seen stimuli, “X’s” for relative defects, and boxes ( absolute defects.

Quantify Defects Same as Two Zone, except the sensitivity at each

missed point is measured relative to the expected threshold. Printouts display circles (O) for seen stimuli, and numbers (in decibels) to indicate the depth of any defects. The greater the number, the lower the retinal sensitivity (deeper the defect).

Test Speed Normal Two stimulus presentation speeds are available.

Slow The test speed may be changed while a test is in

progress. The Normal setting automatically adjusts test speed for a slow responding patient.

Fixation Target Central Yellow light in the center of the bowl.

■) for

Small Diamond The Small Diamond is located below the Central tar-

get, and should be used when a patient cannot see the central fixation light (e.g. macular degeneration). The patient should look in the center of the diamond formed by the four lights.

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Screening Parameter Description Parameters Settings

Large Diamond The Large Diamond is located below the Central

target and is useful for patients with central scotoma who cannot see either the Central fixation light or the Small Diamond.

Bottom LED Some tests have points in the superior visual field

that require a lower fixation light than the central target. The target used is the Bottom LED of the Large Diamond. When testing with the Superior 64 or Superior 36 Screening Speciality tests, the Bottom LED is the default fixation target. It is automatically illuminated at the start of a test.

Fixation Gaze/Blind Spot The Blind Spot and Gaze Monitoring system Monitoring (model 740i - 750i) are both activated.

Gaze Track The Gaze Track system automatically measures gaze (model 740i - 750i) direction at the time of stimulus presentation. Refer

to Section 5: “Gaze Tracking” for more information.

Blind Spot The test program periodically presents a stimulus (Heijl-Krakau) in the patient’s blind spot. If the patient is fixating

well, he or she should not see the blind spot check stimulus. The Blind Spot check stimulus always matches the test stimulus size. Refer to Section 6: “Fixation Losses” for additional information.

Off Disables Gaze Track and Blind Spot fixation moni-

toring. The operator should monitor fixation with the video eye monitor.

Blue-Yellow OFF/ON Model 750i and model 745i (optional on model

740i) can perform Blue-Yellow testing. Blue-Yellow testing uses a Size V blue stimulus presented on a yellow background. Selecting the Blue-Yellow option will cause the system to default to these parameters. See “Blue-Yellow Testing” later in this section for more information.

Because screening strategies have been designed and optimized for White-on-White testing, it is not recommended that screening tests be performed with the Blue-Yellow testing strategy.

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4-6 TEST PARAMETERS AND STRATEGIES

Screening Parameter Description Parameters Settings

Test Mode Age Corrected A hill of vision is assigned to the patient based

on the patient’s age. The expected threshold at the hill’s peak, the fovea, is called the central reference level. This central decibel value is indicated on the test screen and the printout.

The patient’s date of birth must be entered prior to beginning the test. Age corrected mode may only be used with standard stimulus size and color (Size III, White). If non-standard size and color parameters are selected with Age Corrected Screening, the instrument will default back to Threshold Related Strategy upon leaving the Change Parameter Screen.

Threshold A hill of vision is assigned only after threshold Related values for 4 primary points are determined. The cal-

culated threshold at the hill’s peak, or fovea, is called the central reference level. This value appears on the test screen and the printout.

Single Intensity The HFA uses a default intensity level of 10 dB to test

the entire visual field. If a different intensity is desired, press CLEAR and enter the desired value on the keypad which appears. Press ENTER. The single intensity value will appear on the test screen (as Stim:) and on the printout as “Stimulus Intensity”.

Single Intensity levels may be set only in even increments.

Stimulus Size I, II, III, Five stimulus sizes (diameters) are available on

IV, V most instrument models. They range from Size I

(smallest) to Size V (largest). Model 720i has only the Size III stimulus available for testing.

Stimulus Color White White stimulus projected onto bowl.

Red Red stimulus projected onto bowl.

Blue Blue stimulus projected onto bowl.

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Figure 4.2: The Threshold Parameter Setup Screen

Table 4.2: Threshold Test Parameters

(Standard parameter settings appear in bold print)

Threshold Parameter Description Parameters Settings

Test Strategy SITA Standard

™

This is the standard testing strategy for the Swedish Interactive Thresholding Algorithm (SITA). SITA Standard cuts testing time in half relative to the Full Threshold strategy without compromising test reproducibility. See Appendix G for more details.

SITA Fast

™

This is a faster version of SITA. SITA Fast cuts testing time in half relative to the FastPac testing strategy without compromising test reproducibility. See Appendix G for more details.

Full Threshold A “bracketing” technique is used to threshold

each test point. An initial stimulus is presented at a level the patient is expected to see. If seen, the stimulus intensity is decreased in 4 decibel steps (0.4 log units) until the patient no longer sees the stimulus; if not seen, it is increased in 4 dB steps until seen. The instrument then changes direction, moving in 2 dB steps until a change in patient response is made. The last stimulus seen by the patient is recognized as the threshold for that point.

The bracketing process described above begins with 4 primary points whose threshold values are determined at the beginning of the test. The results at these points then influence the starting levels for neighboring points in the pattern.

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4-8 TEST PARAMETERS AND STRATEGIES

Threshold Parameter Description Parameters Settings

™

FastPac

FastPac decreases Full Threshold test time by about 40%. It follows a similar stair-stepping technique as in Full Threshold, but uses 3 dB increments instead of 4 dB and crosses the threshold only once.

Test Speed Normal Same as Screening Parameters

Slow Same as Screening Parameters

Fixation Target Central Same as Screening Parameters

Small Diamond Same as Screening Parameters

Large Diamond Same as Screening Parameters

Bottom LED Some tests have points in the superior visual field

which require a different fixation light than the Central target in order to expand the superior field range. The target used is the Bottom LED of the Large Diamond.

Fixation Gaze/Blind Spot Same as Screening Parameters Monitoring (model 740i - 750i)

Gaze Track Same as Screening Parameters (model 740i - 750i)

Blind Spot Same as Screening Parameters

Off Same as Screening Parameters

Blue-Yellow OFF/ON Model 750i and model 745i (optional on model

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TEST PARAMETERS AND STRATEGIES 4-9

Threshold Parameter Description Parameters Settings

Foveal Threshold Off A threshold value for the fovea will not be

measured.

On A threshold value for the fovea will be determined at

the beginning of the test. The foveal threshold test presents stimuli inside the Small Diamond fixation target; the Small Diamond will automatically be illuminated.

Refer to Section 5: “Foveal Threshold” for details on performing this supplemental test.

Stimulus Size I, II, III, Same as Screening Parameters. Model 720i has only

IV, V the Size III stimulus available for testing.

Stimulus Color White Same as Screening Parameters

Red Same as Screening Parameters

Blue Same as Screening Parameters

Fluctuation On Threshold values for ten (10) pre-selected points

are retested to determine the variability of the patient’s responses.

Threshold values for the retested points are printed on the numeric printout and appear in parentheses directly below the first test result.

Fluctuation values which differ significantly from normal are flagged with appropriate “p” (probability) values.

Off Threshold values for pre-selected points will not be

determined twice. Some points may be retested even if fluctuation is off. Off is the default setting when Blue-Yellow is turned on.

Note: Short-term Fluctuation (SF) and Corrected Pattern Standard Deviation (CPSD) values will not be available if fluctuation is turned off. Neither SF or CPSD are displayed with SITA Standard or SITA Fast tests.

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4-10 TEST PARAMETERS AND STRATEGIES

SITA™ TESTING

Perimetry results are critical in the management of glaucoma and other eye diseases. Yet, obtaining useful results with existing protocols is often difficult to manage. Conventional threshold tests are often long and uncomfortable for patients. They tie-up staff and tire out patients, thus decreasing test reliability. The SITA testing strategy represents a major advance over the methods currently in use.

Carl Zeiss Meditec has developed two separate SITA testing strategies with two separate goals:

1. SITA Standard: The goal was to design a perimetric thresholding method which

collects twice as much information per unit time as the Humphrey Full Threshold standard algorithm. SITA Standard cuts the test time in half without compromising test reproducibility relative to the current international standard.

2. SITA Fast: The goal was to design a thresholding method which collects twice as

much information per unit time as FastPac. SITA Fast cuts the test time in half relative to FastPac, without compromising test reproducibility.

Tests available with SITA Both SITA Standard and SITA Fast are designed to run with these threshold tests:

• Central 10-2

• Central 24-2

• Central 30-2

• Peripheral 60-4

SITA cannot be used with Blue-Yellow (SWAP) testing or for Custom tests.

All SITA tests must use a White, Size III stimulus. Any time a SITA strategy is used, these two parameters will be automatically set by your HFA II.

File directory indication On the File Directory screens, the SITA Standard tests will be indicated by the letters

“SS” and SITA Fast tests will be indicated by the letters “SF”. Example: SF-30-2.

Floppy disk storage SITA generates and utilizes significantly more data. Therefore, SITA tests use more disk

space than is required when storing Full Threshold or FastPac tests. Floppy disks with SITA tests stored on them may hold as few as 100 tests. The maximum number is 500 tests.

Note: Additional information on SITA can be found in Section 7: “SITA Printout Formats” and Appendix G: “How SITA Works”.

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BLUE -YELLOW (SWAP) PERIMETRY

Blue-Yellow perimetry, also known as Short Wavelength Automated Perimetry, or SWAP, differs from standard automated static perimetry only in that a carefully chosen wavelength of blue light is used as the stimulus, and a specific color and brightness of yellow light is used for the background illumination. Except for these differences, SWAP is still a basic static threshold perimetry test in which standard Goldmann stimuli are presented in the standard way.

Advantages of testing Blue-Yellow perimetry has performed much better than standard computerized perimetry in with blue-yellow perimetry several published longitudinal studies. Working independently, researchers from U.C.

Davis

, and U.C. San Diego2 have found that Blue-Yellow perimetry identified early glaucomatous visual field defects years before they could be detected using standard white-onwhite perimetry. In separate work, the Davis and San Diego teams also found that Blue-Yellow perimetry detected progression in glaucomatous field loss significantly earlier than did whiteon-white perimetry managing ocular hypertensives and in detecting neurological disease

How blue-yellow perimetry Blue-Yellow perimetry isolates and measures Blue-Yellow ganglion cell function. The carefully works chosen bright yellow background desensitizes the green and red cones, while having little

effect on blue cone function. The narrow band 440 nanometer blue stimulus falls right on the peak sensitivity of blue cones. Thus, Blue-Yellow perimetry tests the blue cones and their ganglion cell connections.

3,4

. Other papers have found Blue-Yellow perimetry to be superior in

5,6

There are at least two theories as to why Blue-Yellow perimetry provides earlier diagnosis. One theory suggests that the Blue-Yellow ganglion cells are selectively damaged in early glaucoma, and thus earlier Blue-Yellow perimetry diagnosis is just a function of testing the part of the visual system which is damaged first. A second theory suggests that early diagnosis is achieved simply because Blue-Yellow perimetry tests one of several pathways of the visual system; if only a small part of the system is tested, then there is less redundancy, and loss will be discovered earlier.

Established standards for In the beginning of Blue-Yellow perimetry development, there was little agreement on exactly blue-yellow testing how testing should best be done. The wavelength of the blue stimulus, the wavelength and

brightness of the yellow background, and what stimulus size should be used were all considered. Teams at U.C. Davis, U.C. Berkeley, and U.C. San Diego began working together under the sponsorship of Carl Zeiss Meditec to resolve the differences in their approaches and to define an optimized common standard. They presented their recommendations to a larger group from North America and Europe for peer review, criticism, and finally, acceptance. Out of this process has come an internationally accepted standard for Short Wavelength Automated Perimetry

. The Blue-Yellow perimetry system now being offered on the Humphrey perimeter

adheres to this standard.

Note: References are listed in Appendix D along with a Blue-Yellow conversion table and Blue -Yellow specifications. Additional information on Blue-Yellow test interpretation can be found in Section 7.

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4-12 TEST PARAMETERS AND STRATEGIES

Patient selection for blue-yellow perimetry

Blue-Yellow perimetry has been found to be appropriate for early glaucoma detection in:

• ocular hypertensives

• glaucoma suspects

• glaucoma patients with mild to moderate field loss.

1-5

While Blue-Yellow perimetry has the potential of becoming the primary perimetry method used in glaucoma management, we recommend that it be done as a complement to standard Humphrey white-on-white testing until more clinical experience has been gained.

For Neurological Disease:

At least one study has demonstrated that Blue-Yellow testing may be an appropriate and useful test in neurological disease

. With greater clinical experience, Blue-Yellow testing may become the primary perimetric testing method in neurological disease; initially, however, it should be used as an adjunct to standard perimetry.

Patients who may not be candidates:

There are some patients who may not respond well to Blue-Yellow perimetry. This includes patients with:

Blue-yellow testing

• significant cataracts

• advanced White-on-White field loss.

The procedure for testing with Blue-Yellow perimetry is identical to the procedure for testing with white-on-white. One important, additional step is to explain to the patient what to look for. The stimulus may appear as a localized color change (from yellow to violet) or sometimes as an achromatic spot. Users might find it helpful to use the Demo feature or a foveal threshold test to show patients what the new stimulus looks like before testing.

Many patients prefer the standard white-on-white perimetry, even though SWAP testing conditions are no brighter than standard indoor lighting levels. If patients understand what to expect they are much more accepting of new technologies — especially if they also understand that they will benefit in the process. We believe that when your patients have been properly informed about the benefits of Blue-Yellow perimetry, they will adapt to the new test quite well.

When Blue-Yellow testing is activated:

• the bowl illumination changes to yellow

• the stimulus color changes to blue

• the stimulus is changed to Size V (Blind spot check size also changes to Size V)

• Short-term Fluctuation (SF) is turned OFF.

These are the standard settings for performing Humphrey Blue-Yellow perimetry.

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Room illumination should be off or at a very low level in order to preclude significant amounts of stray light from falling on the bowl and affecting Blue-Yellow test conditions.

From the Start of Test screen select CHANGE PARAMETERS. Switch Blue-Yellow from Off to

On and press SELECTION COMPLETE.

Move the visor handle

located under the forehead rest towards the bowl (away from the patient). See Figure 4.3. This helps to shield the patient’s eye from the glare produced by the yellow bowl light. Press OK on the reminder message after you have extended the visor.

Push visor away from the patient

Figure 4.3: Extending the Visor Away From the Patient

Follow the standard testing procedures normally used for white-on-white perimetry for

setting up and explaining the test. The patient’s test eye should adapt to the yellow bowl illumination for about three (3) minutes before beginning the test. Having the patient look into the bowl while you enter patient data and explain the test will help to save time. Repeat the 3 minute adaptation period for the second eye.

Note: The Size V Blind Spot check may cause artificially high fixation losses on certain patients. You may wish to turn off the blind spot monitor and utilize only Gaze Tracking to monitor fixation when testing these patients.

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4-14 TEST PARAMETERS AND STRATEGIES

At the conclusion of

Blue-Yellow testing,

slide the visor back into the forehead rest. See Figure 4.4.

A message will remind you to replace the visor beneath the forehead rest. Move the visor toward you (away from the test bowl). If the visor is not retracted, stimuli in the superior visual field may not be seen beyond 35 degrees during White-on-White testing.

Move visor toward you

Figure 4.4: Returning the Visor to the Retracted Position

Additional Notes on Blue-Yellow Perimetry:

1. Be careful to check the instrument before starting the first test of the day to see that the visor is placed in the retracted position. The visor reminder is not displayed at start up.

2. When beginning the first Blue-Yellow test of the day, the HFA II will go through an extensive diagnostic cycle before you can begin the test. This delay may last up to two minutes and is normal. It is suggested that you set up the first Blue-Yellow test before you seat the patient. Many offices do this when they first turn on the instrument for the day. Be sure to have the room lights very low or off during the initial Blue-Yellow warm-up.

3. If you intend to perform Blue-Yellow testing often, using the Alter Main Menu feature (Section 2) to customize a Main Menu button will make SWAP testing more convenient.

4. Blue-Yellow testing cannot be used with SITA.

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5. Corrected Pattern Standard Deviation (CPSD) values are not available when Short-term Fluctuation is turned OFF. Fluctuation may be turned ON at the Parameter Setup screen without altering any other test parameters. The test will run longer as the HFA II retests additional points when fluctuation is turned ON. If you wish to run most Blue-Yellow tests with fluctuation ON, refer to Section 2: “Altering the Main Menu Screen”.

6. Blue-Yellow perimetry tests take only about 15% longer than conventional perimetry. The most likely explanation for this is simply that current testing algorithms are not fully optimized for Blue-Yellow. In any case, 15% is only about 1 additional minute in a 6 minute test, and does not appear to be a serious drawback. SWAP and STATPAC for BlueYellow both fully support the use of FastPac. Using FastPac will greatly improve patient acceptance simply because it significantly shortens test time.

Specificity of blue-yellow testing

Specificity is the ability of a diagnostic technique to correctly identify actual normals as being normal. Humphrey’s STATPAC for Blue-Yellow was designed to provide the same level of specificity for SWAP as currently enjoyed in standard white-on-white Humphrey perimetry.

The original Blue-Yellow research protocols called for laborious determination of the yellowness of the crystalline lens. One conclusion of these protocols was that such measurements added little if anything to the diagnostic power of the procedure

. Measurement of the crystalline lens does add information about the overall height of the hill of vision, but most of the visual field information used in glaucoma diagnosis has to do with localized sensitivity loss, not with general sensitivity. From a practical point of view, crystalline lens measurements do not appear to be worth the clinical time consumed.

Although Humphrey’s Blue-Yellow Perimetry is available for screening tests in addition to threshold tests, research studies dealing with Blue-Yellow have involved threshold testing exclusively. Because screening strategies have been optimized for white testing, you may find an increased number of screening fields to appear abnormal. We suggest for now you use Blue-Yellow testing only with the threshold testing strategies.

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ALTERNATE COLOR TESTING

(models 740i -750i)

In addition to the standard white stimulus, all central field tests may be performed using a blue or red stimulus on a white background. The filters to create the colored stimuli are listed and characterized below.

Color Filter

Blue 440 nm Blue (model 745i, 750i)

OCLI Dichroic Blue (model 740i)

Red Hoya R62

Note: This is not the same as Blue-Yellow Testing. See previous discussion for details.

Note: STATPAC analysis is not available for tests using either the red or blue stimulus.

Performing a color test

1. From the start test screen, select CHANGE PARAMETERS.

2. Open the stimulus color drop-down menu and choose either BLUE or RED.

3. Proceed as you would for any white stimulus test.

Note: The decibel to apostilb comparison chart in the Appendix is different in color testing than it is in white testing. In color testing, zero decibels still represents the maximum instrument brightness although that maximum brightness is less than 10,000 asb. Decibel values are still valid for comparison of relative brightness for a given color filter.

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Testing

Start Test Options 5-2

Monitoring and Maintaining the Patient's Eye Position 5-4

Supplemental Testing 5-7

Test In Progress 5-10

Test Complete Options 5-14

Testing: A Step-by-Step Guide 5-16

During the testing phase, your responsibility shifts to monitoring the patient’s progress to ensure a successful outcome and reliable results. This section explores your options available during the test. It helps to answer the following questions, and others:

• How do I pause the test to allow the patient to rest?

• If I’ve chosen the wrong eye to begin testing, how do I switch?

• Can I restart a test once it has begun?

• How do Head Tracking and Vertex Monitoring help when trial lenses are used?

• Must I print the test results immediately following a test?

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5-2

START TEST OPTIONS

TESTING

After you have chosen a test, specified which eye is to be tested, and entered the patient data, you will arrive at the Start of Test screen. From this screen you can start the test, display a list of all current parameters, change the parameter settings, and change the test eye.

Figure 5.1: The Start of Test Screen

START

This button initiates the testing sequence, starting with supplemental testing, if chosen. Supplemental tests include foveal threshold measurement or initialization of the Gaze Tracking fixation monitoring system (models 740i, 745i and 750i). Refer to “Supplemental Testing” in this section for additional information.

DISPLAY STATUS

This choice presents a display of all current test parameter settings. Select OK to collapse the pop-up window. You cannot change any settings through DISPLAY STATUS. These settings must be changed by pressing CHANGE PARAMETERS as described in Section 4. The test continues to run when DISPLAY STATUS is selected during a test.

CHANGE PARAMETERS

This function allows you to alter any testing parameter (e.g. test speed, stimulus color) prior to starting the test. Once the test begins, only two parameters may be changed: fixation monitoring and test speed. See previous discussion in Section 4: “Setting Test Parameters” for details.

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TESTING 5-3

DEMO

This feature runs a short practice test. Demo allows the patient to preview what is required during a visual field test. It also allows you to evaluate whether the patient understands your instructions and the use of the patient response button. Patient responses are not recorded during the Demo test. The Demo test starts immediately after you press DEMO.

The Demo test will run for one minute unless you choose to end the Demo test sooner. Once the patient demonstrates competency, press END DEMO to begin the actual test. If END DEMO is not pressed, the pop-up window will disappear after one minute. The test will immediately begin.

Note: The Demo test runs only after the Foveal Threshold is determined and the Gaze Tracking initialization is complete (if utilizing either of these features).

TEST OTHER EYE

This button allows you to switch to the Start of Test screen for the other eye. You will be allowed to add or change patient data at this time.

INTERNAL DIAGNOSTIC ALERT

Frequently, after selecting START or TEST OTHER EYE, the message “Please Wait... Preparing Instrument For Test” appears on the screen. This is a normal function of your instrument. The HFA II is performing a short, self-diagnostic check prior to beginning the test.

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5-4

TESTING

MONITORING AND MAINTAINING THE PATIENT’S EYE

POSITION

Video Eye Monitor All HFA II models feature a video eye monitor. This monitor, which is automatically visible on

the Start of Test screen, enables you to view the patient’s test eye. Accurate placement of the eye is important. When the cross-hatches are seen over the pupil, the eye is centered.

Use the video eye monitor to:

• position the test eye in the center of the trial lens holder

• monitor the patient during testing.

The three controls on the video eye monitor are: a plus sign (+) to brighten the image, a minus sign (-) to dim the image, and an OFF button to turn off the monitor display. To redisplay the monitor, press the upper-left EYE button.

Figure 5.2: The Video Eye Monitor

Gaze Tracking Gaze Tracking is a unique fixation tracking system that records whether the patient is (model 740i - 750i) properly fixating while stimuli are being presented. A brief initialization procedure is required

at the start of each test to calibrate and adjust the gaze tracker to the patient’s eye. It is imperative, therefore, that the patient maintain the same position during gaze initialization and testing. Deviations are recorded and displayed on the test screen and on the printout.

Note: Some patients with small pupils, ptotic lids, interfering lashes, or strong prescriptions may not be good candidates for gaze monitoring.

At the Start of Test screen, you can make changes to the fixation monitoring system or turn the monitoring system off entirely by pressing CHANGE PARAMETERS and selecting the desired option. Gaze monitoring may only be selected at the start of a test, although it may be turned off at any time during the test.

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TESTING 5-5

The gaze graph The gaze graph is a useful method for documenting movement of the patient’s test eye. A test

starts with no markings on the gaze graph. As time progresses, the graph expands from the right, marking eye movement and blinks.

Upward markings indicate that the test eye deviated from the fixation target at the time of stimulus presentation. The higher the marking, the greater the deviation. The direction of deviation from the fixation target is not indicated. Only the magnitude is recorded.

Downward markings indicate that the gaze system could not locate the patient’s gaze: small downward markings indicate that the system was unable to detect gaze direction; large markings indicate that the patient blinked while the stimulus was being presented. Minimal deviation of the markings (depicted as a horizontal line) indicates excellent fixation. Refer to Figure 5.3 for an example of a gaze graph that displays an example of good fixation. An example of poor fixation is shown in Figure 5.4.

Large eye deviation

+10˚

0˚

Good, steady fixation

blinks

Figure 5.3: Example of a Gaze Graph: Good Fixation with a Large Number of Blinks

+10˚

0˚

Figure 5.4: Example of a Gaze Graph Indicating Poor Fixation

Head tracking The Head Tracking feature helps maintain proper alignment of the head and eye relative to the (model 750i) trial lens holder. As part of the gaze initialization process, the HFA II analyzes and records the

patient’s eye position. When Head Tracking is turned ON, the instrument will move the chin rest in increments of 0.3 mm, readjusting the patient to the original Gaze Track initialization position. Maintaining proper alignment during testing reduces trial lens scotoma and increases the reliability and accuracy of test results.

Note: Head Tracking only works when the trial lens holder is in use and Gaze Tracking has been successfully initialized. Head Tracking is only necessary when a trial lens is used. To turn Head Tracking off during a test, press FIXATION to access the Change Fixation Monitoring screen. Head

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tracking is only turned off for the length of the current test.

5-6

TESTING

It is possible in certain situations for the Head Tracking feature to “lose its place”. The most common reason for this is a sudden shift of the eye or repositioning of the head. A patient whose head does not move with the chin rest will cause Head Tracking to beep. A pop-up window will appear giving you the opportunity to continue or discontinue using Head Tracking. The HFA II continues testing while the message is on the screen. You should re-instruct your patient at this point. Make sure that the chin rest supports the patient’s head. This will ensure that the head moves with the chin rest.

Vertex monitor The Vertex Monitor will beep and display a message on the touch screen if the patient backs (model 750i) away more than 7 mm from his or her original position. This helps to eliminate the trial lens as

a source of visual field defects. Refer to Section 2: “System Setup – Vertex Monitor” for instructions on turning on the Vertex Monitor.

The vertex reading is based on the initial patient position in front of the trial lens. To set:

1. Make sure that the trial lens holder is in the up position in front of the eye

2. Properly align and instruct the patient

3. Initialize the Gaze Tracking feature

he Vertex Monitor alarm will beep if the patient has backed away from the trial lens. Testing will continue uninterrupted and a message will remain on the screen until cleared by the operator. Check the position of the patient’s forehead and reposition if necessary. If the Vertex Monitor continues to sound, press RE-INITIALIZE VERTEX. The test will pause as the screen displays the Gaze Track initialization sequence. This will reset the Vertex Monitor. The Vertex Monitor may also be turned off from this screen or by pressing FIXATION from the Test in Progress screen. The Vertex Monitor is turned off only for the length of the current test.

Note: The Vertex Monitor only works when the trial lens holder is in use and Gaze Tracking has been successfully initialized. The Vertex Monitor is only necessary when a trial lens is used.

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TESTING 5-7

SUPPLEMENTAL TESTING

Foveal Threshold and Gaze Track Initialization are performed before a test begins. They are called “supplemental tests”.

Foveal Threshold The Foveal Threshold test measures the sensitivity of the central part of the macula, the fovea.

Foveal threshold testing is the only available with threshold visual field tests. Whenever the Foveal Threshold parameter is turned ON, the Foveal Threshold test is the first supplemental test procedure. Press CHANGE PARAMETERS to turn Foveal Threshold ON.

After pressing START, the Foveal Threshold test will be initiated.

Test Bowl

The small diamond fixation

target will light up below the central fixation target. Instruct the patient to look at the center of the lower fixation lights (in the center of the diamond).

Central Fixation Target

Fixation Diamonds

Tell the patient to press the response button whenever a light is seen inside of

the fixation diamond.

Press START to begin the Foveal Threshold test.

When completed, a second

pop-up window will appear. The yellow light will return to the Central fixation target.

Direct the patient to look at the central fixation light. Press START to begin Gaze Tracking initialization (or begin the test if Gaze Tracking is inactive).

Note: The Foveal Threshold value will be displayed in the center of the visual field on the test screen. It is recorded below the reliability indices on the printout.

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5-8

Gaze tracking initialization The advantages of Gaze Tracking were previously explained in this section. If gaze monitoring

is active, the Gaze Tracking initialization will occur before the testing begins.

From the appropriate

testing screen, press

the START button.

When gaze monitoring

is engaged, you will

automatically get an operator message.

TESTING

Position

the patient so that

the patient’s test eye is located in the center of the video eye monitor (within the small, central box). Use the chin rest control to adjust the patient. The cross-hatch sign should be in the middle of the pupil, as shown.

Instruct the patient to look at the fixation target and try not to blink. Ask the patient to

open his or her eyes wide for about a count of twenty, or until you say the process is over.

Press START to initiate gaze setup. Pressing CANCEL returns you to the Start of Test screen.

Notes:

1. Patients with droopy eyelids should keep their eyes open as wide as possible. Do not adjust the chin rest during Gaze Tracking Initialization.

2. To be effective, Gaze Tracking needs the patient to be looking at the Central fixation target. Do not attempt to use gaze tracking if using one of the lower fixation targets (Small diamond, Large diamond, Bottom LED). Use Blind Spot instead. The blind spot monitor is off-set the appropriate amount to compensate for the different angle of fixation when using the lower fixation targets.

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TESTING 5-9

If Gaze Track Initialization

is successful, press

CONTINUE to begin testing.

Note: It is important that the patient maintain the same position during gaze initialization and testing.

If Gaze Track Initialization

is unsuccessful, press RETRY TO INITIALIZE GAZE. Refer to “Fixation Monitoring” in this section if you are faced with repeated unsuccessful attempts.

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5-10

TESTING

TEST IN PROGRESS

You have several options while a test is in progress.

PAUSE

This button halts the test and allows the patient to rest. The patient can also pause the test by continuously holding down on the response button.

Once in the pause mode, you may choose to resume the test, display the current test parameter settings, change the fixation monitoring system, change the test speed, or cancel the test.

If you cancel the test while in the Pause mode, all data collected up to that point will be deleted and the program will return to the Start of Test screen. Non-standard parameters will be retained, if originally chosen. Before the instrument deletes the data, you will be asked to confirm your request.

DISPLAY STATUS

his feature is available to you during testing so that you can verify the current parameter

settings.

FIXATION

This button gives you the option of changing the fixation monitoring during the test. Gaze monitoring cannot be initiated once the test has begun.

TEST SPEED

During testing, the instrument automatically adjusts the test speed based on how quickly or slowly the patient responds to the stimuli. Nevertheless, if you observe that the pace is too fast, the TEST SPEED button will allow you to slow the test manually. Press the SLOW button to change the pace of the test program. The test speed will reset to normal at the completion of the test.

CANCEL TEST

This choice will discontinue the test, delete all results, and return you to the Start of Test screen. Non-standard parameters will be retained, if originally chosen. Before the instrument deletes the data you will be asked to confirm your request.

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Zeiss Humphrey Field Analyser II i-Series User manual 1

Specifications and Main Features

Frequently Asked Questions

User Manual