Zeiss HUMPHREY 720i User manual

HUMPHREY®
FIELD ANALYZER II - iseries
USER’S GUIDE
Model 720i• Model 740i• Model 745i• Model 750i
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Carl Zeiss Meditec Inc.
5160 Hacienda Drive
Dublin, CA 94568
General Inquiries [phone]
[phone]
www.meditec.zeiss.com
Customer Service [phone]
In Europe please contact:
Carl Zeiss Jena GmbH
Carl Zeiss Promenade 10
Jena 077405
Germany
Ph: [phone]
Fax: [phone]
www.zeiss.de
Copyright
© 2003 Carl Zeiss Meditec Inc. All rights reserved.
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.
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Humphrey®Field Analyzer II - iseries
User’s Manual Revision Control
PART NUMBER REVISION TITLE RELEASE DATE
51680-1 B Humphrey® Field Analyzer II - iseries 3-2003
User’s Guide
Models 720i, 740i, 745i, 750i
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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
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
Table of Contents (this manual contains 314 pages)
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1Introduction/
Instrument Setup
(18 pages)
2General Operation
(24 pages)
3Setting-up Tests
(24 pages)
4Test Parameters & Strategies
(16 pages)
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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 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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5Testing
(18 pages)
6Test
Reliability
(8 pages)
7STATPAC Analysis &
Printing Results
(30 pages)
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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 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 9-22
Custom Testing 10-1
Creating Custom Tests 10-2
Deleting Custom Tests 10-15
Performing Custom Tests 10-17
Printout Format 10-19
10Custom Testing
(20 pages)
9Database
Management
(22 pages)
8File
Functions
(20 pages)
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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 & 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
AHFA II Product Specifications A-1
BWarranty Statement and Notification of Copyright B-1
CIcon Glossary C-1
DGoldmann Conversion Tables D-1
ETest Patterns E-1
FInstalling New HFA II Software F-1
GHow SITA Works / Acknowledgments G-1
HTroubleshooting / Parts List H-1
Appendix
(36 pages)
12Care &
Cleaning
(14 pages)
11Kinetic
Testing
(62 pages)
Index
(6 pages)
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Introduction/Instrument Setup
1
Welcome
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®Field
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.
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.
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1-2 INTRODUCTION / INSTRUMENT SETUP
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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 glau-
coma, 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 detec-
tion. 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
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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
Inferior
60°
Nasal
60°
Temporal
90°
70°
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”.
BLIND
SPOT
FOVEA
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 patho-
logical change.
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1-4 INTRODUCTION / INSTRUMENT SETUP
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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
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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®Field Analyzer II. Equally important, the latest models represent improvements
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.
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 espe-
cially 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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1-6 INTRODUCTION / INSTRUMENT SETUP
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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
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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 Monitor-
ing 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
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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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INTRODUCTION / INSTRUMENT SETUP 1-9
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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
presence
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.
• 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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1-10 INTRODUCTION / INSTRUMENT SETUP
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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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INTRODUCTION / INSTRUMENT SETUP 1-11
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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 self-
diagnostic 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.
Symbol definitions The following symbols appear on the HFA II:
Power On Power Off
Projector Bulb Brightness
Air Intake Filter USB Port
Serial RS-232
Communication Port
VGA Monitor
Keyboard
Printer
Mouse
Floppy Disk Drive Network
Important Instructions
Found in Manual
Fuse
Uninsulated High Voltage
Inside the Instrument
Risk of Electric Shock
Type B Class I
Figure 1.3: HFA II Symbol Definitions
Data
Patient Response
Button
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1-12 INTRODUCTION / INSTRUMENT SETUP
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Power cord outlet
Power switch
Air filter
Touch screen
brightness control
Finger divot for
opening rear
panel
Touch screen
Hard drive
Floppy drive
Magneto-Optical Drive
Chin rest control
Figure 1.4: The HFA II – Side View
Patient response button
Figure 1.5: The HFA II – Rear View – See Figure 1.7 for View Without Rear Panel
SYSTEM COMPONENTS
Location of Model
and Serial Number
Cables emerge through
opening here
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