Humphrey Field Analyzer

576 Pages·2010·14.63 MB·English

Humphrey Field Analyzer
■
II-i series System Software Version 5.1
User Manual
Copyright
© 2010 Carl Zeiss Meditec, Inc. All rights reserved.
Trademarks
EasyConnect, FastPac, FORUM, GPA, Humphrey, HFA, HFA-NET Pro, SITA, SITA Fast, SITA Standard,
and SITA-SWAP, are either registered trademarks or trademarks of Carl Zeiss Meditec, Inc. in the
United States and/or other countries.
Windows and Windows Server are registered trademarks of Microsoft Corporation in the United
States and/or other countries.
Bonjour, the Bonjour logo, and the Bonjour symbol are trademarks of Apple Computer, Inc.
HP, LaserJet, PCL, and DeskJet are registered trademarks of Hewlett-Packard Company.
VxWorks is a registered trademark of Wind River Systems, Inc.
All other trademarks used in this document are the property of their respective owners.
Document Applicability
This document applies to the HFA II-i series instrument, System Software Version 5.1 or higher,
unless superseded.
Humphrey Field Analyzer II-i series User Manual 2660021140973 A
Contents
i
Contents
(1) Introduction & Instrument Setup..................................................1-1
•Intended Use...............................................................................................1-1
•Indications for Use.......................................................................................1-1
•Purpose of This User Manual......................................................................1-4
•Symbols......................................................................................................1-5
•Instrument Disposition...............................................................................1-9
•Disposal......................................................................................................1-9
•WARNING: User Changes to Software or Hardware...................................1-9
•Instrument Installation...............................................................................1-9
•Tips to Avoid Damage................................................................................1-10
•HFA II-i Embedded License........................................................................1-10
•Product Compliance...................................................................................1-11
•Product Safety...........................................................................................1-11
•Electromagnetic Compatibility (EMC)........................................................1-12
•Accessory Equipment.................................................................................1-15
•About Visual Fields....................................................................................1-16
•The Humphrey Advantage.........................................................................1-19
•System Components.................................................................................1-22
•Additional Components.............................................................................1-24
•System Assembly......................................................................................1-30
(2) General Operation..........................................................................2-1
•General Information...................................................................................2-1
•Using the File Directory..............................................................................2-8
•The Main Menu Screen...............................................................................2-9
•System Setup............................................................................................2-10
•Additional Setup.......................................................................................2-30
•Help Screens.............................................................................................2-32
(3) Setting-Up Tests.............................................................................3-1
•Selecting the Test Pattern and Test Eye.......................................................3-1
•Entering Patient Data.................................................................................3-7
•Using Trial Lenses.....................................................................................3-20
•Preparing the Patient................................................................................3-24
(4) Test Parameters and Strategies...................................................4-1
•Setting Test Parameters..............................................................................4-1
•Test Strategies............................................................................................4-4
•SITA Testing..............................................................................................4-10
(5) Testing.............................................................................................5-1
•Start Test Options.......................................................................................5-2
•Monitoring and Maintaining the Patient’s Eye Position.............................5-3
•Supplemental Testing.................................................................................5-7
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Contents
ii
•Test in Progress.........................................................................................5-10
•Fixation Monitoring..................................................................................5-11
•Tips for Gaze Tracking and Head Tracking.................................................5-13
•Test Complete Screen Options...................................................................5-13
•Testing: A Step-by-Step Guide...................................................................5-16
(6) Test Reliability................................................................................6-1
•Factors Affecting Reliability........................................................................6-2
•Evaluating Reliability..................................................................................6-4
(7) STATPAC Analysis & Printing.........................................................7-1
•Introduction To STATPAC Analysis...............................................................7-2
•Threshold Test Printout Formats.................................................................7-3
•Printing Current Threshold Test Results.....................................................7-16
•Screening Printout Formats.......................................................................7-16
•Printing Current Screening Test Results.....................................................7-18
•Printing Previously Saved Test Results.......................................................7-19
•Grayscale Symbols....................................................................................7-21
(8) Guided Progression Analysis (GPA).............................................8-1
•Introduction to GPA....................................................................................8-2
•Overview of GPA Reports............................................................................8-4
•Understanding GPA Reports.....................................................................8-10
•Establishing the GPA Baseline...................................................................8-12
•Clinical Interpretation of GPA Results........................................................8-13
•GPA Case Studies.......................................................................................8-15
•How To Print GPA Reports........................................................................8-29
•How to Activate GPA Software on the HFA II-i.........................................8-35
(9) Short-Wavelength Automated Perimetry (SWAP)......................9-1
•Introduction to Short-Wavelength Automated Perimetry...........................9-1
•SITA-SWAP Testing......................................................................................9-3
•Printing Out SITA-SWAP Results.................................................................9-8
•SITA-SWAP Case Studies...........................................................................9-10
•Licensing SITA-SWAP on Your HFA.............................................................9-14
(10) File Functions.................................................................................10-1
•File Functions Menu.................................................................................10-2
•Retrieving the File Directory.....................................................................10-4
•Selecting Tests from the File Directory......................................................10-9
•Performing File Functions........................................................................10-13
•Serial Transfer of Tests Between HFA I, HFA II or HFA II-i Instruments.....10-19
•Organizing Patient Files..........................................................................10-24
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Contents
iii
(11) Database Management................................................................11-1
•Introduction to Database Management....................................................11-2
•Patient Database Protection Procedures...................................................11-3
•Configuration Back Up and Restore..........................................................11-5
•How to Handle Database Failures...........................................................11-10
•Merging Databases................................................................................11-22
•Cleanup Hard Disk Database..................................................................11-23
•Care and Handling of Removable Storage Media...................................11-24
(12) Custom Testing..............................................................................12-1
•Creating Custom Tests...............................................................................12-1
•Deleting Custom Tests.............................................................................12-13
•Performing Custom Tests.........................................................................12-16
•Printout Formats......................................................................................12-17
(13) Kinetic Testing...............................................................................13-1
•Introduction to Kinetic Testing..................................................................13-2
•Performing Kinetic Perimetry Manually....................................................13-3
•Pre-Defined Kinetic Test Patterns.............................................................13-13
•Running Automated Kinetic Tests............................................................13-14
•Social Security Administration Kinetic Disability Test.............................13-24
•Special Mapping.....................................................................................13-27
•Viewing Kinetic Tests..............................................................................13-39
•Printing Kinetic Tests..............................................................................13-43
•Designing a Custom Kinetic Test Pattern................................................13-48
•Creating the Aphakic SSA Disability Test................................................13-56
(14) Networking....................................................................................14-1
•Chapter Organization...............................................................................14-2
•Network Configurations...........................................................................14-3
•An Overview of HFA-NET Pro....................................................................14-5
•How to Use the HFA’s Networking Features............................................14-13
•Backing Up Data to the Server.................................................................14-14
•Restoring Data from the Server...............................................................14-16
•Synchronizing Databases on Two or More HFA II-i Perimeters.................14-18
•Using Patient Folders..............................................................................14-25
•Transferring Tests....................................................................................14-30
•Using the Save/Transmit Option..............................................................14-33
•Printing To a File.....................................................................................14-36
•Using an EMR/PMS/DICOM System........................................................14-38
•Exporting to EMR/PMS/DICOM Systems.................................................14-41
•Importing Work Lists from Non-DICOM EMR/PMS Systems and
DICOM Systems using DICOM Gateway 1.0............................................14-45
•Importing Work Lists from DICOM Systems using DICOM Gateway 2.0.14-48
•Recall Patients, View, or Print Tests from a DICOM Archive 
(DICOM Gateway 2.0 only).....................................................................14-53
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•Imported Patient Rules and Conflicts.....................................................14-58
(15) Care and Cleaning.........................................................................15-1
•General Use Principles..............................................................................15-2
•Cleaning the HFA II-i.................................................................................15-2
•Replacing Parts.........................................................................................15-4
•Operating the Printrex Printer..................................................................15-9
•Touch Screen Calibration.........................................................................15-11
•Using Removable USB Storage Devices and Floppy Disks........................15-12
(A) Product Specifications...................................................................A-1
(B) Product Features............................................................................B-1
(C) Legal Notices...................................................................................C-1
(D) Icon Glossary..................................................................................D-1
(E) Goldmann Conversion Tables........................................................E-1
•Conversion Table for Blue-Yellow................................................................E-5
•Blue-Yellow Specifications..........................................................................E-6
(F) Test Patterns...................................................................................F-1
•Screening Test Patterns...............................................................................F-1
•Threshold Test Patterns...............................................................................F-4
•Specialty Tests Patterns..............................................................................F-6
(G) EasyConnect RCT 1.0......................................................................G-1
•Overview.....................................................................................................G-1
•Before You Run the RCT.............................................................................G-2
•Enable the RCT and Name HFA II-i Instruments.........................................G-3
•Launch the RCT..........................................................................................G-4
•Easy Mode (default)...................................................................................G-6
•Copy Mode...............................................................................................G-14
•Custom Mode..........................................................................................G-20
•Report Mode.............................................................................................G-31
•Test Mode................................................................................................G-35
•Troubleshooting.......................................................................................G-43
(H) DICOM Gateway 2.0 (Optional).....................................................H-1
•Overview.....................................................................................................H-1
•DICOM Gateway 2.0 Configuration Overview............................................H-2
•HFA II-i Configuration................................................................................H-2
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v
(I) Networking Reference....................................................................I-1
•Licensing HFA-NET Pro and DICOM Gateway 2.0.........................................I-1
•Connecting Your Network Components.......................................................I-3
•Setting Up Your HFA Network......................................................................I-4
•File Server Access Protocol for FTP or Shared Folder...................................I-8
•Archiving Data...........................................................................................I-14
•Setting Up Save & Transmit to a Network File Server.................................I-21
•Setting Up Exporting to Non-DICOM EMR/PMS Systems and
DICOM Systems using DICOM Gateway 1.0...............................................I-22
•Setting Up Work Lists for Non-DICOM EMR/PMS Systems and
DICOM Systems using DICOM Gateway 1.0...............................................I-23
•Setting Up Save & Transmit for EMR/PMS/DICOM Systems........................I-24
•Setting Up Printing To a File......................................................................I-25
•Backing Up and Restoring Your HFA Network Configuration.....................I-27
•Network Diagnostics.................................................................................I-28
•Network Troubleshooting Error Messages.................................................I-31
•DICOM Networking Error Messages..........................................................I-37
•Networking Terminology...........................................................................I-38
•Serial Communications Protocols Used by HFAs........................................I-40
(J) Installing & Licensing HFA II-i Software......................................J-1
•System Software Installation.......................................................................J-2
•Installing Additional Software.....................................................................J-3
•Licensing GPA, SITA-SWAP, HFA-NET Pro, or DICOM Gateway 2.0...............J-5
(K) SITA Normative and GPA Databases............................................K-1
•How SITA Works.........................................................................................K-1
•Normative and GPA Database Collection and Demographics.....................K-3
•Acknowledgements....................................................................................K-8
(L) Reference to Older Test Strategies...............................................L-1
(M) Troubleshooting............................................................................M-1
•Accessories and Supplies List....................................................................M-8
Index................................................................................................N-i
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Humphrey Field Analyzer II-i series User Manual 2660021140973 A
Introduction & Instrument Setup 1-1
(1) Introduction & Instrument Setup
Intended Use 1-1
Purpose of This User Manual 1-4
Symbols 1-5
Instrument Disposition 1-9
Disposal 1-9
Instrument Installation 1-9
Tips to Avoid Damage 1-10
Product Compliance 1-11
Product Safety 1-11
Electromagnetic Compatibility (EMC) 1-12
Accessory Equipment 1-15
About Visual Fields 1-16
The Humphrey Advantage 1-19
System Components 1-22
Additional Components 1-24
System Assembly 1-30
You are about to use the most advanced automated perimeter available, the Humphrey® Field
Analyzer II-i series (HFA™ II-i ). This introductory section covers general information about the HFA
II-i, including a brief discussion of visual fields and a summary of important instrument features.
After reading this chapter you will be familiar with:
• the importance of visual field testing
• general principles of perimetry
• unique features of the HFA II-i
• installation and safety precautions
• connecting the printer and optional external devices
Intended Use
The Carl Zeiss Meditec, Inc. Humphrey Field Analyzer II-i is an automatic perimeter which is
intended to be used to measure the visual field of the eye.
Indications for Use
The Humphrey Field Analyzer II-i is an automated perimeter intended to identify visual field defects
for the purposes of screening, monitoring and assisting in the diagnosis and management of ocular
diseases such as glaucoma, and related neurological disorders.
The Carl Zeiss Meditec, Inc. Guided Progression Analysis is a software analysis module for the
Humphrey Field Analyzer II (HFA II) and Humphrey Field Analyzer II-i series (HFA II–i ) that assists
practitioners with the detection, measurement, and management of progression of visual field loss.
Humphrey Field Analyzer II-i series User Manual 2660021140973 A
1-2 Introduction & Instrument Setup
It aids in assessing change over time, including change from baseline and rate of change. It is
intended for use as a diagnostic device to aid in the detection and management of ocular diseases
including, but not limited to, glaucoma.
☞ Note: These perimetry results are an aid to interpretation, not a diagnosis. The doctor’s judgment
is still the most important element in determining the clinical significance of the results, including
considering the limitations of the statistical package.
Patient Population
The Humphrey Field Analyzer II-i may be used on all adults and children over the age of six in need
of diagnostic evaluation of the eye. This includes (but is not limited to) patients with the following
disabilities or challenges:
• Wheelchair user
• Very low or not measurable visual acuity
• Postural problems
• Fixation problems
• Deafness
• Large body, but not those above 99th percentile based on anthropomorphic data
There is a general requirement that the patient be able to sit upright and be able to place their face
in the chin and forehead rest of the instrument (with or without supplemental human or mechanical
support).
Part of the Body
The Humphrey Field Analyzer II-i physically interacts with the patient’s forehead and chin. The
patient's hand and fingers (or similar ability) are also required to press the Patient Response button.
Application
The Humphrey Field Analyzer II-i is designed for continuous use, although it is expected that most
sites operate the instrument for 10 hours or less per day, indoors, within a medical office or hospital
setting. This setting shall have clean air free of soot, vapors from adhesives, grease, or volatile
organic chemicals. Other Operating Environment specifications are given in Appendix (A), "Product
Specifications,". Application related warnings are given in Chapter (1), "Introduction & Instrument
Setup," and elsewhere.
User Profile
We assume that users are clinicians with professional training or experience in the use of
ophthalmic equipment, and in diagnostic interpretation of the test results. Specific assumptions
regarding the profiles of individuals performing instrument operation or data interpretation are
given below. This manual contains information that will aid in the proper instrument operation and
interpretation of the resultant data.
Humphrey Field Analyzer II-i series User Manual 2660021140973 A