Zeiss Humphrey Field Analyser II i-Series User manual 2

Humphrey Field Analyzer

■ II-

series System Software Version 5.1

User Manual

Trademarks

EasyConnect

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 t

, FastPac, FORUM, GPA, Humphrey, HFA, HFA-NET Pro, SITA, SITA Fast, SITA Standard,

he 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This document applies to the HFA II-i series instrument, System Software Version 5.1 or higher, unless superseded.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 2660021145640 A

Contents

(1) Introduction & Instrument Setup..................................................1-1

•Intended Use ...............................................................................................1-1

•Indications for Use.......................................................................................1-1

•Purpose of This User Manual ...................................................................... 1-4

•Symbols and Labels .................................................................................... 1-5

•Instrument Disposition ............................................................................... 1-8

•Disposal...................................................................................................... 1-8

•User Changes to Software or Hardware...................................................... 1-9

•Instrument Installation ............................................................................... 1-9

•Tips to Avoid Damage................................................................................. 1-9

•HFA II-i Embedded License ........................................................................1-10

•Product Compliance...................................................................................

•Product Safety ...........................................................................................1-11

•Electromagnetic Compatibility

•Accessory Equipment................................................................................. 1-16

•About Visual Fields .................................................................................... 1-17

•The Humphrey Advantage ........................................................................ 1-20

•System Components ................................................................................. 1-23

•Additional Components ............................................................................ 1-25

•System Assembly .......................................................................................1-31

(EMC) ........................................................ 1-12

1-11

(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

•Supplemental Testing ................................................................................. 5-7

Position ............................. 5-3

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

Contents

•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..................................................................................

(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

6-4

(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

(11) Database Management ................................................................11-1

•Introduction to Database Management.................................................... 11-2

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

Contents

•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....................

•Performing Kinetic Perimetry Manually .................................................... 13-3

•Pre-Defined Kinetic Test Patterns.............................................................13-13

•Running Automated Kinetic Tests............................................................13-14

•Social Security Administration Kinetic Disability T

•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 ................................................

.............................................. 13-2

est ............................. 13-24

13-56

iii

(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 S

DICOM Systems using DICOM Gateway 1.0.............................................. 14-45

•Importing Work Lists from DICOM System

•Recall Patients, View, or Print

(DICOM Gateway 2.0 only) ....................................................................... 14-54

•Imported Patient Rules and Conflicts ..................................................... 14-59

Tests from a DICOM Archive 

s using DICOM Gateway 2.0 .14-48

ystems and

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

(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

(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

(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

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

•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.....................................................................

•Licensing GPA, SITA-SWAP, HFA-NET Pro, or DICOM Gateway 2.0...............J-5

J-3

(K) SITA Normative and GPA Databases............................................ K-1

•How SITA Works ......................................................................................... K-1

•Normative and GPA Database Collection and D

•Acknowledgements ....................................................................................K-8

(L) Reference to Older Test Strategies ...............................................L-1

(M) Troubleshooting ............................................................................ M-1

•Accessories and Supplies List ....................................................................M-8

Index ................................................................................................ N-i

emographics.....................K-3

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

Introduction & Instrument Setup

(1) Introduction & Instrument Setup

Intended Use 1-1

Purpose of This User Manual 1- 4

Symbols and Labels 1- 5

Instrument Disposition 1- 8

Disposal 1- 8

Instrument Installation 1- 9

Tips to Avoid Damage 1- 9

Product Compliance 1-1 1

Product Safety 1-1 1

Electromagnetic Compatibility (EMC) 1-12

Accessory Equipment 1-16

About Visual Fields 1-17

The Humphrey Advantage 1- 20

1-1

System Components 1- 23

Additional Components 1- 25

System Assembly 1- 31

You are about to use the most advanced aut Analyzer IIII-

, 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-

• installation and safety precautions

• connecting the printer and optional external devices

series (HFA™ II-

). This introductory section covers general information about the HFA

mated perimeter available, the Humphrey® Field

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.

Note: These perimetry results are an aid to interpre is still the most important element in determining the clinical significance of the results, including considering the limitations of the statistical package.

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

tation, not a diagnosis. The doctor’s judgment

1-2

Introduction & Instrument Setup

Essential Performance

The Essential Performance of the instrument is to p

Patient Population

The Humphrey Field Analyzer IIof 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 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 IIpatient's hand and fingers (or similar ability) are also required to press the Patient Response button.

may be used on all adults and children over the age of six in need

physically interacts with the patient’s forehead and chin. The

rovide accurate visual field measurements.

sit upright and be able to place their face

Application

The Humphrey Field Analyzer IIsites 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 pr 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.

Instrument Operation

Demographic The user should be adult, and at least one of the following:

• Ophthalmologist

•Optometrist

•Nurse

is designed for continuous use, although it is expected that most

ofessional training or experience in the use of

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

Introduction & Instrument Setup

• Certified Medical Technician

• Ophthalmic Photographer

• Non-certified Assistant

Occupational Skills The user should be able to perform all of the following tasks:

• Power on the instrument

• Enter, find, and modify patient identifying data

• Clean surfaces that contact patient

• Position patient with the instrument, including moving the pat height, and the patient’s chair

• Select and initiate a test

• Review and save a test or try again

• Generate an analysis report

• Review the analysis report for completeness

• Save, print, or export an analysis report

•Archive data

• Power off the instrument

1-3

ient, the instrument, the table

Data Interpretation

Demographic The user should be one of the following:

• Ophthalmologist or other Medical Doctor

• Optometrist or equivalent

Occupational Skills The user should have the following skills:

• See Instrument Operation above

• Ability to work with elderly patien

Job Requirements The user should have training and certification in the analysis and tr

or other eye-related medical issues as required by governing bodies.

ts and those with disabilities

eatment of ophthalmic diseases

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

1-4

Introduction & Instrument Setup

Purpose of This User Manual

Carl Zeiss Meditec designed this User Manual to serve as a training, usage and reference guide. While we offer training in the use of the HFA IIinterpretation. This manual does not attempt to do so.

To fully appreciate the capabilities of the HFA IIrecommend that you rely on this User Manual as your training and reference guide. 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 IIlearn and easy to operate. For optimum results:

• Read your User Manual 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.

, we do not offer instruction in diagnostic

and to develop good testing techniques, we

. The friendly touch control makes it inviting to

Note: HFA IIaltering the button locations, functions, and text from the prior software version. This manual depicts the screens in the prior software style. Regardless of style, text and buttons on screen images depicted in this manual are identical to those in the Ver. 5.x software screen images.

Model Differentiation

This guide contains instructions for Models information is relevant to all models, some information applies only to particular models. When a feature or function applies only 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 discussion of “SWAP

(Blue-Yellow) Testing (Models 745i and 750i),” on page 1- 2 1. Conversely, model numbers are not

specified when information is standard or optional on all models. Y your instrument on the rear panel of the HFA IIbutton located in the upper, left-hand corner of the screen (see “The Information Button,” on

page 2-3). Refer to Appendix (B), "Product Features,", if you ar

capabilities of your instrument.

Text Conventions

The terms “select,” “choose,” “touch,” and “press” a initiate an operator action using the touch screen, external keyboard, glidepad, 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-

series system software Ver. 5.x has updated the style of the user interface without

720i, 740i, 745i and 750i. Although much of the

ou can find the model number of

or you may access this information via the “i”

e unsure about the particular

re used interchangeably. Each term means to

models.

UPPER CASE LETTERS are reserved for references to specific command buttons found on the touch

een. The exceptions to this are messages on test printouts, the words STATPAC, SITA™, SWAP,

scr HFA II-

, and headings.

Italicized words

figures, pictures, tables, and special notes in this manual.

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

are used to identify the icon buttons on the right border of the screen, the titles of

Introduction & Instrument Setup

Bold words are used to highlight warnings and section headings.

1-5

This manual means “left-click” when it says, “click,” except

Chains of menu items are indicated with the use of the “>” “

File>Exit

Access Menu Options

To access the options offered through each menu, click on the menu headings. Then click on an op

Electronic User Manual Access

The HFA IIDocumentation CD included in the instrument accessory kit. If you do not have Adobe Reader installed, go to www.adobe.com to download and install the free Adobe Reader.

Additional References

The User Manual cannot possibly cover every situatio especially interpretation questions. Your HFA IIprovides an overview of visual field results. R. Anderson and Vincent Michael Patella (Mosby, Inc., St. Louis), is recommended for in-depth information and analysis of visual fields.

” directs you to select Exit in the File menu.

tion to select it. Click outside all menu options to make the options disappear.

• Some menus are fields tagged with a down-arrow ( options, click on the down-arrow.

• Grayed-out menu options or

User Manual in Acrobat PDF format for use on a computer is on the HFA II-i User

buttons are not available.

comes with a copy of

Automated Static Perimetry, Second Edition,

where “right-click” is specified.

symbol between items. For example,

drop-down lists). To access these menu

n you may encounter with the HFA II-i,

Essential Perimetry

, which

by Douglas

Symbols and Labels

WARNING

CAUTION

Must follow Instruction for Use

Type B applied parts

Alternating Current Fuse

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

1-6

Introduction & Instrument Setup

CAUTION: Hot Surface

Manufacturer

Date of Manufacture

Authorized European Community Representative

Serial number

Catalog number / part number

Model number

Patent

System Software USB Flash Drive

Calibration Software USB Flash Drive

GPA Sample Data USB Flash Drive

European Conformity

Disposal of the Product within the EU. Do not dispose via domestic waste disposal system or communal waste disposal facility.

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

Introduction & Instrument Setup

Power On

Power Off

Projector Lamp

Brightness

Air Intake Filter

Serial RS-232 Communication Port

VGA Video Port

Printer

Keyboard/Mouse

USB Port

Network Port

Patient Response Button

Port

DO NOT USE

Additional symbols appearing on the HFA II-i:

1-7

Figure 1.1 : Additional HFA II-i Symbol Definitions

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

1-8

Introduction & Instrument Setup

Protective Packing Symbols

The protective packing symbols on the shipping carton specify the handling requirements and the tran

sport and storage conditions for the HFA IIsymbols in the event that your HFA IIuse.

must be stored for a period of time, prior to its set up and

Handling Requirements Transport and Storage Conditions

as it is shipped from the factory. Note these

Fragile, Handle with Care

Keep Dry

This end up Atmospheric Pressure Limits (500 hPa

Relative Humidity (10% to 100%, including condensation

Tem

per atur e (-40 to +70 deg. C)

to 1060 hPa)

Instrument Disposition

When it comes time to upgrade the HFA, please contact Carl Zeiss Meditec to inquire about trade-in or upgrade values we may offer. Should you not wish to trade in the instrument, please see the Disposal section below.

Disposal

CAUTION: This product contains electronic components. At the end of its lifetime, the product should be disposed of in accordance with the relevant national regulations.

Disposal of the Product within the European Union (EU)

In accordance with applicable EU guidelines at the time at market, the product specified on the consignment note is not to be disposed of via the domestic waste disposal system or communal waste disposal facilities.

For further information on disposal of this product, please cont manufacturer or its legal successor company. Please read the latest internet information provided by the manufacturer.

Where the product or its components are resold, the seller must inform the buyer that the product must be disposed of in accor

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

dance with the currently applicable national regulations.

which the pr

oduct was brought onto the

act your local dealer or the

Introduction & Instrument Setup

User Changes to Software or Hardware

The HFA II-i is a medical device. The software and hardware have been designed in accordance with U.S., European and other international medical device standards designed to protect clinicians, users and patients from potential harm caused by mechanical, diagnostic or therapeutic failures.

1-9

WARNING: Unauthorized modification of HF peripherals) can jeopardize the safety of operators and patients, the performance of the instrument, and the integrity of patient data; it also voids the instrument warranty.

Approved Software

Use of software supplied or approved by Carl Zeiss Meditec for the HFA IIcurrent list of approved software call Carl Zeiss Meditec Customer Care: In the U.S., call 800-341-6968. Outside the U.S., contact your local Carl Zeiss Meditec distributor.

Note: Carl Zeiss Meditec does not provide technical support for the use of unappr software.

A II-i software or hardware (including

is authorized. For the

oved third party

Instrument Installation

Only an authorized Carl Zeiss Meditec service representative should install the with the buyer, Carl Zeiss Meditec schedules one free on-site installation appointment after instrument delivery. System installation and operator training require approximately one-half business day.

Care in Handling

Use extreme care when handling and transporting the HFA IIcontains fragile optics that have been precisely aligned at the factory.

shipping boxes. The instrument

HFA II-i. In consultation

Installation Requirements

• The HFA IIconfigure your HFA II-

• An isolation transformer is required when connecting peripher Device approved (i.e., printer, USB drive, etc.) within 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.

should operate on a dedicated power outlet. Based on your specification, we

at the factory to use either 100V, 115V, or 230V line voltage.

al devices that are not Medical

Tips to Avoid Damage

Note: Users are not authorized to dismantle or modify the HFA II-i hardware. To transport the instrument outside the office, you must consult with a Carl Zeiss Meditec service technician. Failure

to do so voids all warranties offered with the HFA II-

• Only Carl Z In the case of malfunction, error messages or operational problems, call Carl Zeiss Meditec Customer Care: In the U.S., call 800-341-6968. Outside the U.S., contact your local Carl Zeiss Meditec distributor.

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

eiss Meditec authorized technicians should disassemble or service this instrument.

1-10

Introduction & Instrument Setup

• This instrument has no special measures to protect against harmful ingress of water or other liquids (classified IPXO—ordinary equipment). Do not place containers of liquid on or near the instrument, nor use aerosols on or near it.

• In case of emergency related to the instrument, unplug the power cor call for service immediately.

• With the exception of the main power fuses and k in the instrument. For the replacement of any component, accessory, or peripheral, except fuses or the keyboard, call Carl Zeiss Meditec Customer Care: In the U.S., call 800-341-6968. Outside the U.S., contact your local Carl Zeiss Meditec distributor.

• Although this instrument is designed for con not in use for an extended period.

• This instrument operates according to specifications under standar lighting conditions, without exposure to any direct sunlight.

eyboard, there are no user-replaceable parts

tinuous operation, it should be turned off when

HFA II-i Embedded License

Each HFA II-i is issued with an embedded VxWorks® operating system license.

d from the wall outlet and

d indoor office (fluorescent)

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

Introduction & Instrument Setup

0297

Product Compliance

Complies with 93/42/EEC Medical Device Directive.

Complies with US and Canadian medical electrical system safety requirements.

Product Safety

This instrument is classified as follows:

• Class I Equipment

•

Type B – Degree of protection against electric shock of applied part (chinand forehead rests, and patient button).

• Ordinary Equipment (IPX0)–

• Continuous Oper

General Safety Requirements

• Although the HFA II-i is designed for continuous operation, it should be turned off when not used for an extended period of time. The HFA II-

• Use the instrument cover to protect the HFA II-i at all times when it is not in use.

• Do NOT place the cover over the instrument when the HFA IIairflow can cause overheating and damage to sensitive components.

• 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.

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

– Protection against electrical shock.

Degree of protection against ingress of liquids (none).

ation – Mode of operation.

should be used in a cool, dry dust-free setting.

is turned on, as loss of proper

1-11

Warnings and Cautions

WARNING: Do NOT block the ventilation openings. These allo heat generated during operation. A buildup of heat due to ventilation opening blockage can cause failures which may result in a fire hazard.

WARNING: To prevent electric shock, the instrument must be plugged into an earthed ground outlet. Do not remove or disable the ground pin. Only an authorized Carl Zeiss Meditec service representative may install the instrument.

WARNING: Do not use the printer or the instrument or the optional power table with an extension cord or a power strip (multiple portable socket outlet). For additional safety, do not plug the printer and the instrument (or the optional power table) into the same wall outlet. Failure to observe this warning could result in electrical shock to the patient and/or examiner.

WARNING: Do not open the instrument covers. Opening the instrument covers could expose you to electrical and optical hazards.

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

for the release of

1-12

Appliance Coupler (input power plug)

HFA Instrument

Introduction & Instrument Setup

WARNING: If the instrument is externally connected to non-medical peripheral devices (i.e. printer, storage devices, etc.), the complete system must comply with the system requirements in standard IEC 60601-1. This standard requires the usage of an Isolation Transformer to power the non-medical peripheral device(s) if located within

1.5 m from the patient. If the peripheral device is located outside the patient environment (beyond 1.5 m) and is connected to the HFA, a separation device must be used or there shall be no metal to metal connection between the non-medical peripheral device and the HFA.

The person or the responsible organization connecting additional devices or reconfiguring the system must evaluate the complete system to ensure compliance to the applicable IEC 60601-1 requirements. The instrument operator must not attempt to touch the patient and the peripheral device simultaneously.

WARNING: Do not reconfigure system components on the table, nor add non-system devices or components to the table, nor replace original system components with substitutes not approved by Carl Zeiss Meditec. Such actions could result in failure of the table height adjustment mechanism, instability of the table, tipping and damage to the instrument, and injury to operator and patient.

CAUTION: The appliance coupler (shown on the left) is the main disconnect device of the instrument. Position the instrument in such a way to have easy access to disconnect the appliance coupler in case of an emergency.

CAUTION: In case of an emergency, disconnect the appliance coupler.

WARNING: This instrument may cause ignition of flammable gases or vapors. Do NOT use in the presence of flammable anesthetics such as nitrous oxide, or in the presence of pure oxygen.

WARNING: Avoid tipping. Do not use the instrument on an uneven or sloped surface. Do not roll the table in deep pile carpet or over objects on the floor such as power cords. Failure to observe these precautions could result in tipping of the instrument and/or table and resulting injury to operator or patient and damage to the instrument.

Electromagnetic Compatibility (EMC)

Note: The HFA II-i needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided herein.

Note: Portable and mobile RF communications equipment can affect medical electrical equipment.

WARNING: The use of accessories, transducers and cables other than those specified may result in increased emissions or decreased immunity of the equipment.

WARNING: The HFA II-i should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used.

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

Introduction & Instrument Setup

Guidance and manufacturer’s declaration - electromagnetic emissions

The HFA II-i is intended for use in the electromagnetic environment specified below. The customer or user of the HFA II-i should ensure that it is used in such an environment

Emissions Test Compliance Electromagnetic environment - guidance

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RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic emissions

IEC 61000-3-2

Voltage fluctuations/

ick

er emissions

Group 1

Class A

Complies

The HFA II-i uses R its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The HFA II-i is suit establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

F energy only for

able for

use in all

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Introduction & Instrument Setup

Guidance and manufacturer’s declaration - electromagnetic immunity

The HFA II-i is intended for use in the electromagnetic environment specified below. The customer or user of the HFA II-i should ensure that it is used in such an environment

Immunity Test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Electrostatic

Discharg

e (ESD)

± 6 kV contact

± 8 kV air

IEC 61000-4-2

Electrical fast

ient/burst

trans

IEC 61000-4-4

± 2 kV for power

supply lines

± 1 kV for

input/output lines

Surge IEC 61000-4-5 ± 1 kV differential

mode V common

± 2 k

mode

Voltage dips, short

interruptions, and

oltage variations on

power supply input

lines. IEC 61000-4-11

Power Frequency

Hz)

0/60

<5% U

40% U

70% U

<5% U

(>95% dip in

) for 0.5 cycle

(60% dip in

) for 5 cycles

(30% dip in

) for 25 cycles

(95% dip in

) for 5 sec.

3 A/m 3 A/m Power frequency magnetic fields should

magnetic field IEC 61000-4-8

± 6 kV contact

± 8 kV air

± 2 kV for power

supply lines

V for

± 1 k

input/output lines

± 1 kV differential

mode V common

± 2 k

mode

<5% U

40% U

70% U

<5% U

(>95% dip in

) for 0.5 cycle

(60% dip in

) for 5 cycles

(30% dip in

) for 25 cycles

(95% dip in

) for 5 sec.

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a

cal commercial or hospital

typi environment.

Mains power quality should be that of a

cal commercial or hospital

typi environment.

Mains power quality should be that of a typical com

mercial or hospital environment. If the user of the HFA II-i requires continued operation during power mains interruptions, it is recommended that the HFA II-i be powered from an uninterruptible source.

be at levels char

acteristic of a typical location in a typical commercial or hospital envrionment.

Note: U

is the a.c. mains voltage prior to application of the test level.

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

d 1.17 P=

d 2.33 P=

Introduction & Instrument Setup

Guidance and manufacturer’s declaration - electromagnetic immunity

The HFA II-i is intended for use in the electromagnetic environment specified below. The customer or user of the HFA II-i should ensure that it is used in such an environment

Immunity Test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Portable and mobile RF communications equipmen any part of the HFA II-i, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

t should be used no closer to

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Conducted RF IEC 6

1000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 8 0 M H z

3 V/m

80 MHz to 2,5 GHz

3 V

3 V/m

80 MHz to 800 MHz

800 MHz to 2,5 GHz

where P is the maximum output power rat

ing of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters,

as determined b

survey,

should be less than the

an electromagnetic site

compliance level in each frequency

range.

Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency applies. Note 2: These guidelines may not apply in all situations. Electromag

netic propagation is affected by absorption

and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the HFA II-i is used exceeds the applicable RF compliance level above, the HFA II-i should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the HFA II-i.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Introduction & Instrument Setup

Recommended separation distances between portable and mobile RF communications equipment and the

-i

HFA II

The HFA II-i is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the HFA II-i can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the HFA II-i as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmit

For transmitters rated at a maximum output power not listed above, the r metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the higher frequency applies. Note 2: These guidelines may not apply in all situations. Electr and reflection from structures, objects and people.

ter

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz

0,01 0.117 0.117 0.233

0,1 0.370 0.370 0.737

1 1.170 1.170 2.330

10 3.700 3.700 7. 368

100 11.700 11.700 23.300

Separation distance according to frequency of transmitter

d = 1.17

commended separation distance d in

omag

netic propagation is affected by absorption

d = 2.33

Accessory Equipment

WARNING: Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (e.g., IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore, all configurations shall continue to comply with the applicable system requirements of IEC 60601-1 standard. Any person who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible for ensuring that the complete system complies with the applicable system requirement of IEC 60601-1 standard. If in doubt, consult the technical service department or your local representative.

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

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 automated perimeter, used to evaluate the visual field.

1-17

The purpose of visual field testing, or perimet

• diagnosing ocular diseases, especiall

• evaluating neurological diseases

• monitoring the progress of ocular and neurological diseases

Visual field testing can lead to early detection and tr 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 Tests Measure

When evaluating visual performance, clinicians ar 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 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. 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 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.

ry, is to provide information critical to:

y glaucoma

eatment of disease. In the case of glaucoma,

e primarily interested in two retinal functions:

those areas less sensitive than the fovea—

a very specific level of stimulus detection. The

Visual field tests can yield information that is gener 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.

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

al in nature, as with screening tests, or more

1-18

60º

90º

60º

70º

Superior

Inferior

Nasal

Tem po ra l

Blind Spot

Fovea

Introduction & Instrument Setup

Normal Versus Pathologic Fields

The visual field normally extends more than 90 70

º inferiorly. That means a person can potentially perceive stimuli within this range while staring at

º temporally, 60º nasally and superiorly, and about

a fixed point.

Figure 1.2 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 1.3 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 of vision are viewed as visual field defects and caused by some pathological change.

A visual field defect, or scotoma, is categorized as either re 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

lative or absolute. A relative defect is an

the blind spot, and is an example of an absolute scotoma.

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

Introduction & Instrument Setup

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 the Visual Field

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Over the years, visual field testing devices have varied in size, complexity The fundamental premise has remained the same, however; patients must respond when they see a stimulus.

Static threshold testing evaluates retinal function. The te 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.

In a second type of retinal evaluation, called kinetic testing, a is moved into the visual field from a non-seeing area, until it is detected by the patient. Typically, the stimulus is brought toward the center from several directions and the operator marks the location at which the patient first detects the stimulus (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 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.

Patient Fixation and Test Reliability

In order for any visual field test to be useful clinically factor affecting reliability is the steadiness of patient fixation. Unless the eye being tested fixates accurately on the target while responding to stimuli, the results are unreliable.

, or ring of equal contrast sensitivity. Targets of varying size and brightness are

rm “static” refers to a stationary stimulus

light stimulus of fixed characteristics

, it must yield reliable results. One important

, and testing methodology.

Other factors adversely affecting reliability are:

• patient fatigue and anxiety

• poor test instructions

• patient discomfort

• improper near vision correction for central testing

Benefits of Computerized Perimetry

Certainly the advancements in microprocessor technology within the last 20 years have profound effect on perimetry. Perimeters have evolved into a more precise measuring tool yielding highly repeatable results.

These changes are better appreciated by examining t both patient and professional:

• Reproducible testing conditions

• Data storage capability; results can be compared over time and software

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

he benefits computerized perimeters bring to

analyzed using expert-system

had a

1-20

Introduction & Instrument Setup

• More sensitive testing; advances in algorithm development has made static perimetry superior to the kinetic method for identifying defects

• Ease of operation; menu-driven software makes au

The Humphrey Advantage

Over 25 years of advancements in research, design and development are reflected in the Humphrey Field Analyzer IIfrom around the world who generously have shared their best ideas with Carl Zeiss Meditec. With tens of thousands of 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 IIavailable.

Ergonomic Design

The HFA II-i relieves many physical discomforts associated with visual field testing. The chin rest and bowl shape allow patients to assume a more natural and re The power table improves patient comfort by permitting the HFA IIof the patient adjusting to the instrument. This especially is important for wheelchair bound patients.

. Equally important, the latest models represent improvements suggested by users

tomated perimeters easy to learn and use

from other autoperimeters that are

laxed sitting position when taking tests.

to adjust to the patient instead

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 beeps each time it is pressed to give immediate feedback to the patient and to the operator.

Easy Operation

Sophisticated instrumentation need not be complicated. The HFA IIintended 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

• Confirmation screens reduce unintentional data loss.

• A keyboard, glidepad, trackball or mouse can be connected to the HFA IIinput devices.

• An optional keyboard with built-in glidepad is available for HFA models that were not delivered with one.

Rapid Testing

Carl Zeiss Meditec’s SITA (Swedish Interactive Thre precise visual field measurements with unprecedented speed. SITA is a rapid, reliable, state-of-the-art autoperimetric technology that is available only with the Humphrey Field Analyzer. With the SITA strategies, users can obtain visual field information in half the time it takes using conventional testing algorithms without compromising accuracy. For further explanation of the SITA testing strategy, refer to Appendix (K).

on all models.

sholding Algorithm) testing strategies allow

offers a number of features

as optional data

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

Sophisticated Data

Introduction & Instrument Setup

1-21

The Humphrey Field Analyzer’s statistical software, ST 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

• Using results from a single test, STATPAC can poin not be evident until subsequent tests were done.

• STATPAC can identify areas that look suspicious normals data.

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

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

• The HFA IIanalysis. These include databases for SITA and databases for Full Threshold and FastPac™ test results.

• Another database consisting of stab Analysis (GPA™) for following change in the progress of the disease. Refer to Chapter (8),

"Guided Progression Analysis (GPA)," for further details.

provides separate, clinically validated, age-normative databases for STATPAC

to help you identify visual field change:

le glaucoma patients is used with the Guided Progression

ATPAC, provides immediate expert analysis of

t out suspicious areas that otherwise might

but which, in fact, compare favorably with

highly sensitive and informative analysis

superior and inferior hemifields to

SITA-SWAP™, in addition to the original

SWAP (Blue-Yellow) Testing (M

Blue-Yellow perimetry is also known as Short-Wavelength Automated P with Models 745 early detection of glaucomatous changes, according to published longitudinal studies.

Blue-Yellow perimetry differs from standar 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. The ability to use SITA for SWAP testing greatly reduces the time involved. See Chapter (9), "Short-Wavelength Automated Perimetry (SWAP)," for more information on SWAP and SITA-SWAP.

Automatic Fixation Monitoring

The HFA IItarget 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 IIstandard Heijl-Krakau blind spot monitoring.

Models 740 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 on the test screen for monitoring during the test. The Gaze Track graph is included on the printout to provide a permanent record of the patient’s fixation.

and 750

employs several methods for ensuring that patients maintain proper fixation of the

, 745i and 750i also offer Gaze Tracking: a patented, high precision system which uses

). It has performed better than standard computerized perimetry for the

odels 745i and 750i)

erimetry, or SWAP, (available

d static white-on-white perimetry only in that a carefully

also offers

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

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Introduction & Instrument Setup

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 b from the lens. These features help to eliminate the trial lens as a possible sour field results.

Data Protection Features

ehind the lens and is held at the proper distance

ce of unreliable visual

Visual field results need to be saved a of data storage methods to file the results. Five USB ports are provided for connection to USB devices, two of which may be used simultaneously with USB storage devices. Floppy disk data storage is available with an optional USB floppy disk drive. Using HFA-NET Pro, you can either archive or back up vital test results to a network file server in your office. There are a number of additional data protection features that work internally to safeguard your data from loss or serious damage. This manual describes in great detail the procedures for creating extra copies of your data. Refer to Chapter (11), "Database Management," for further information on database security. Refer to Chapter (14), "Networking," for further information about connecting your HFA IIoffice computer network.

Risks of Internet Connectivity

CAUTION: When connected to the Internet, th serious security risks, including viruses and worms that could disable your system or adversely affect its performance. Internet connectivity enables third party software drivers and updates to be downloaded to your system, either automatically or intentionally. Installation of any unapproved software, including drivers, could degrade the performance of the instrument and/or lead to corrupted diagnostics or therapeutic information and may void the instrument warranty.

Networking Features

nd protected for future use. The HFA II-i offers you a number

into your

e HFA instrument may be vulnerable to

HFA II-

series perimeters offer many useful networking capabilities for patient data, test data, and

image files. These include:

• export patient data, test results, and image files (PDF and

• synchronize databases on two or more HFA II-

• back up patient data and test results to a

• restore patient data and test results from a

• import work lists from non-DICOM and DICOM EMR/PMS systems

• import patient information and exam data from a DICOM system (DICOM Gateway 2.0 only)

• export patient data, image files, and test r

• export raw exam data and reports to a DICOM system (DICOM Gateway 2.0 only)

Information on the Internet

New information about your HFA IIaddress is: www.meditec.zeiss.com/hfa.

Humphrey Field Analyzer II-i series User Manual 2660021145640 A

may be found on the Carl Zeiss Meditec web site. The internet

perimeters via archiving and retrieval

file server for safe external storage

network file server to an HFA II-

esults to non-DICOM and DICOM EMR/PMS systems

TIFF format) to a file server

+ 550 hidden pages