Zeiss Humphrey Field Analyzer 3 840, Humphrey Field Analyzer 3 830, Humphrey Field Analyzer 3 850, Humphrey Field Analyzer 3 860 Instructions For Use Manual

2660021166131 Rev. A 2018-112660021166131 Rev. A 2018-11

Humphrey® Field Analyzer 3 (HFA3)

Instructions for Use – Models 830, 840, 850, 860

Trademarks

FastPac, FORUM, Guided Progression Analysis, GPA, Humphrey, HFA, Liquid Trial Lens, SITA, SITA Fast, SITA Faster, SITA Standard, SITA-SWAP, STATPAC, RelEYE, Visual Field Index, and VFI are either registered trademarks or trademarks of Carl Zeiss Meditec, Inc in the United States and/or other countries.

Windows, Windows Vista, and Windows Server are registered trademarks of Microsoft Corporation in the United States and/or other countries.

HP is a registered trademark of Hewlett-Packard Company.

Intel is a registered trademark of Intel Corporation.

Bonjour, the Bonjour logo, and the Bonjour symbol are trademarks of Apple Computer, Inc.

All other trademarks used in this document are the property of their respective owners.

Patents

www.zeiss.com/meditec/en_us/imprint/patents.html

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

Table of Contents

(1) Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Operating Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

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

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

Purpose of This User Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Symbols and Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

Instrument Disposition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

User Changes to Software or Hardware. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Instrument Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

HFA3 Licenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Product Compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Product Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

iii

Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

(2) Software Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1

Contents Software Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Steps to Upgrade Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

(3) Getting Started. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1

Instrument Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Startup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Instrument Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

(4) Setup and Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1

Perform Threshold or Suprathreshold Test. . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Perform Kinetic Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15

Create Custom Test Patterns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22

Set up Test Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24

Delete Test Profiles and Patterns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24

(5) Quick Reference Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Start Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Prepare for Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Preliminary Tests (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Perform the Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

Review and Save Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

(6) Data, Tests & Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1

Save Test Reports and Test Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Print Test Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

Reassign Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

Delete Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

Import Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

View and Generate Test Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

Merging and Deleting Patient Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6

Static Threshold Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6

Report Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12

Suprathreshold Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15

Kinetic Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16

(7) Networking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Network Capabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Configuration to Pre-existing Office Network . . . . . . . . . . . . . . . . . . . . . . . 7-2

Connect to a DICOM/EMR Server. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

Connect to a Printer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8

(8) Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Cleaning the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Replacing the Stimulus Projection Lamp . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

Liquid Trial Lens Care. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4

Accessories and Supplies List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

(9) Data Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1

Set Up a Serial Transfer from an HFA II or HFA II-i . . . . . . . . . . . . . . . . . . . . 9-1

(10) Data Synchronization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1

Installation & Configuration of Data Synchronization Function. . . . . . . . . 10-2

(11) Data Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

Data Backup on Shutdown and Data Restore . . . . . . . . . . . . . . . . . . . . . . 11-1

(12) Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1

HFA3 Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1

(A) Test Patterns & Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-1

Threshold Test Patterns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

Suprathreshold Test Patterns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

Test Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8

(B) Determine Trial Lens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-1

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

Guidelines for Trial Lens Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

How to Calculate the Spherical Equivalent . . . . . . . . . . . . . . . . . . . . . . . . . B-1

Error Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1

Troubleshooting Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3

(D) Legal Notices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1

Software Copyright . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1

End User Software License Agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

Go to Contents Introduction

(1) Introduction

This introductory section covers general information about the Humphrey® Field Analyzer 3

™

(HFA

3).

Operating Principles

A patient's visual field can be assessed by briefly projecting a spot of light (“stimulus”) of known size, brightness, and location on the inside surface of a roughly hemispherical bowl. Bowl illumination is controlled to establish a desired contrast between the stimulus and the area around it. Stimulus location and presentation timing are algorithmically varied to minimize the patient’s ability to anticipate stimulus location and timing. Stimulus brightness is algorithmically varied to determine the dimmest stimulus that can be reliably seen at each location. The resulting visual field map is used by a trained and qualified physician as an aid in diagnosis. Historically, also known as the Humphrey Field Analyzer (HFA), this instrument is the gold standard of perimetry worldwide.

In addition to static perimetry, the HFA3 allows you to perform kinetic perimet manual standard Goldmann perimetry. You can manually select kinetic isopters, or perform custom scans automatically or step by step.

Intended Use

ry that emulates

1-1

The Humphrey Field Analyzer 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 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: The HFA3 is not intended to be used as the sole diagnostic method for disease.

Patient Population

The HFA3 may be used on all adults and children over the evaluation of the eye. This includes (but is not limited to) patients with the following disabilities or challenges:

• Wheelchair user

• Very low or not measur

• Postural problems

• Fixation problems

• Deafness

• Large body, but not those above 99th p

There is a general requirement that the patient be able face on the chin and forehead rest of the instrument (with or without supplemental human or mechanical support).

able visual acuity

ercentile based on anthropomorphic data

to sit upright and be able to place his or her

age of six in need of diagnostic

Part of the Body

The HFA3 physically interacts with the patient’s forehead and chin. The patien (or similar ability) are also required to press the patient response button.

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

t's hand and fingers

1-2

Introduction Go to Contents

Application

The HFA3 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 should have clean air free of soot, vapors from adhesives, grease, or volatile organic chemicals. Other Operating Environment specifications are given in Application related warnings are given in this chapter and elsewhere throughout the manual.

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.

Instrument Operation

Demographic

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

• Ophthalmologist

•Optometrist

•Nurse

• Certified Medical Technician

• Ophthalmic Photographer

• Non-certified Assistant

Chapter (12), "Specifications".

Occupational Skills (Frequently used functions)

The user should have appropriate training in order 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 patient, the instrument, the table 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

Data Interpretation

Demographic

The user should be one of the following:

• Ophthalmologist or other Medical Doctor

• Optometrist or equivalent

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

Go to Contents Introduction

Occupational Skills

The user should have the following skills:

•See Instrument Operation on page 1- 2.

• Ability to work with elderly patients and those with disabilities

Job Requirements

The user should have training and certification in the analysis and treatment of ophthalmic diseases or other eye-related medical issues as required by governing bodies.

Purpose of This User Manual

The HFA3 Instructions for Use instructs the user in the procedures for operating the instrument, testing the patient, and reviewing and printing test reports. The screens presented by the instrument are designed to be intuitive.

Note: Trademarked terms, terms related to DICOM usage, and some networking terms are not translated from English on the user interface and

Models

This guide contains instructions for Models 830, 84 hardware upgrades differentiate models. See Model Features on page 3-5.

in the instructions for use.

0, 850, and 860. Licensed software and various

1-3

Text Conventions

The terms “select,” “choose,” “touch,” “pr using the touch screen, external keyboard, or mouse.

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

Electronic User Manual Access

The HFA3 User Manual, created in Acrobat PDF format for use on a computer HFA3 User Documentation USB included in the instrument accessory kit. If necessary, go to

www.adobe.com to download and install the free Adobe Reader.

ess,” and “tap” each mean to initiate an operator action

where “right-click” is specified.

, is provided on the

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

1-4

Introduction Go to Contents

Symbols and Labels

WARNING

CAUTION

Must Follow Instructions For Use.

DisplayPort

USB Port

Network Port

Power Switch

Type B applied parts

Patient Response Button

Headphones

Direct Current

Alternating Current

CAUTION: Hot Surface

Manufacturer

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

Go to Contents Introduction

Date of Manufacture

Authorized European Community Representative

Serial number

Catalog number / part number

Model number

Patent

European Conformity

1-5

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

Safety Information

Warning: Indicates a hazardous situation which may appropriate safety precautions are not heeded.

Caution: Indicates a hazardous situation which may result the device if the appropriate safety precautions are not heeded.

Protective Packing Symbols

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

ransport and storage conditions for the HFA3 as it is shipped from the factory. Note these symbols

in the event that the HFA3 must be stored for a period of time prior to its setup and use.

Handling Requirements Transport (Packaged)

Fragile, Handle with Care Humidity (10% to 95%)

Keep Dry Temperat ure (–40 to +70 deg. C)

result in death or serious injury if the

in minor or moderate injury or damage to

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

1-6

Introduction Go to Contents

This end up

Atmospheric Pressure Limits (500 hPa to 1060 hPa)

Instrument Disposition

When it comes time to upgrade the HFA3, please contact ZEISS 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)

Packaging materials should be retained for

If you wish to dispose of the packaging material, con recycling.

The device contains electronic components. At the end of its lifetime, the pr batteries should be disposed of in accordance with the relevant national regulations.

In accordance with applicable EU guidelines and national r product was brought onto the 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 con 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 in to be disposed of in accordance with the currently applicable national regulations.

future relocation or repair.

tact a recognized collection system for

oduct and its integrated

egulations at the time at which the

tact your local dealer or the

form the buyer that the product is

User Changes to Software or Hardware

The HFA3 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.

WARNING: Unauthorized modification of HFA3 software or hardware (including peripherals) can jeopardize the safety of operators and patients, the performance of t

he instrument, and the integrity of patient data; it also voids the instrument

warranty.

Approved Software

Only use of software supplied or approved by ZEISS for the HF approved software call ZEISS Customer Care: In the U.S., call 800-341-6968. Outside the U.S., contact your local ZEISS distributor.

Note: ZEISS does not provide technical support for the use of unapproved third party software.

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

A3 is authorized. For the current list of

Go to Contents Introduction

Instrument Installation

1-7

An authorized with the buyer, ZEISS schedules one free on-site installation appointment after instrument delivery. The owner/operator receives training by Zeiss prior to using the HFA3 instrument for the first time. System installation and operator training require approximately one-half business day.

Care in Handling

Use extreme care when handling and transporting the HFA3 shipping boxes. The instrument con

tains fragile optics that have been precisely aligned at the factory.

Installation Requirements

• The HFA3 should be connected to a dedicated power outlet. The HF specifications when connected to any AC main supply in the range 90 to 264Vac, 47Hz to 63Hz.

• An isolation transformer is required when connecting peripher Device approved (for example; printer, USB drive) 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.

ZEISS

service representative or the owner/operator can install the

HFA3. In consultation

A3 will operate within its

al devices that are not Medical

HFA3 Licenses

Each HFA3 is issued with two Windows® operating system licenses: an embedded version and a consumer version.

Product Compliance

Complies with 93/42/EEC Medical Device Directive.

The product is RoHS-compliant accor

ding to Directive 2011/65/EU.

Product Safety

This instrument is classified as follows:

•

Class I Equipment – Protection against electrical shock.

•

Type B – Degree of protection against electric shock of applied part (chin and forehead rests,

and patient response button).

• Or

dinary Equipment (IPX0) – Degree of protection against ingress of liquids (none).

• Co

ntinuous Operation – Mode of operation.

General Safety Guidelines

Note: Users are not authorized to dismantle or modify the HFA3 hardware. To transport the instrument outside the office, you must consult with a ZEISS voids all warranties provided with the HFA3.

•

Only ZEISS authorized technicians should disassemble or service this instrument. In the

case of malfunction, error messages or operational problems, call ZEISS Customer Care: In the U.S., call 800-341-6968. Outside the U.S., contact your local ZEISS distributor.

• This instrument has no special measures to protect against harmful ingress of water or other liq

uids (classified IPXO—ordinary equipment). Do not place containers of liquid on or near the

instrument, nor use aerosols on or near it.

service technician. Failure to do so

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

1-8

Introduction Go to Contents

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

• The projection lamp, Trial Lens holder and Liquid Trial Lens keyboard, and fan filter are all user-replaceable parts. For the replacement of any other instrument component, accessory, or peripheral, call ZEISS 800-341-6968. Outside the U.S., contact your local ZEISS distributor.

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

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

• Do NOT place the cover over the instrument when the HFA3 is turned on, as loss of proper airflow

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.

Warnings and Cautions

WARNING: Do not block the ventilation openings. These allow for the release of heat generated during operation. A buildup of heat due to ventilation opening block

age can cause failures which may result in a fire hazard.

tinuous operation, it should be turned off when

™

, patient response button, external

Customer Care: In the U.S., call

standard indoor office (fluorescent)

WARNING: To prevent electric shock, the instrument must be plugged into an earthed ground outlet. Do not remove or disa authorized ZEISS service representative may install the instrument.

WARNING: Do not use the instrument or the optional power table with an extension cord or a power strip (multiple portable sock 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.

WARNING: If the instrument is externally connected to AC powered, non-medical peripheral devices (for example; printers, storage devices), the complete system m

ust 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 electrical connection between the non-medical peripheral device and the HFA. The HFA3 Ethernet port already has the required separation integrated within the HFA3 instrument, and therefore can be directly connected to peripherals located beyond 1.5 meters.

The person or the responsible or reconfiguring the system must evaluate the complete system to ensure compliance to the applicable IEC 60601-1 requirements.

ganization connecting additional devices or

ble the ground pin. Only an

et outlet). Failure to

The instrument operator must not touch the patient and the peripheral device simultaneousl

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

Go to Contents Introduction

WARNING: Do not reconfigure system components on the table, nor add non-system devices or components to the table, nor components with substitutes not approved by ZEISS. 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.

If the power table or any part of the system is reconfigured or replaced or if any e

xternal devices are connected to the instrument, the operator must ensure that the complete system continues to comply with the requirements defined in IEC 60601-1.

CAUTION: The appliance coupler (power cord) is the main disconnect device of the instrument. Position the instrument in such a wa 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 or oxidizers such as nitrous oxide

or pure oxygen.

y to have easy access to disconnect the

replace original system

1-9

WARNING: Avoid tipping. Do not use the instrument on an uneven or sloped surface. Do not roll the table from one locati on the table. Move the table alone to the new location and then move and place the instrument on top of the table. 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.

CAUTION: Make sure your USB devices are secured against malware/viruses. Patient data on USB devices can become corrupted when inserting into computers for backup or transfer. The

use of anti-virus software on computers is recommended and is the responsibility of the

user.

on to another while the instrument is

Electromagnetic Compatibility (EMC)

Note: The HFA3 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 equipmen

WARNING: The use of accessories, transducers, and cables other than those specified may result in in equipment.

WARNING: The HFA3 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 t be used.

o verify normal operation in the configuration in which it will

creased emissions or decreased immunity of the

t can affect medical electrical equipment.

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

1-10

Introduction Go to Contents

Guidance and manufacturer’s declaration - electromagnetic emissions

The HFA3 is intended for use in the electromagnetic environment specified below

. The customer or user of the HFA3 should ensure that it is

used in such an environment.

Emissions Test Compliance Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1 The HFA3 uses RF energy only for its internal

function. Ther

efore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Harmonic emissions IEC 61000-3-2

Voltage fluctuations/flicker emissions

Class A The HFA3 is suitable for use in all

ts other than domestic

Class A

establishmen establishments and those connected to a low voltage power supply network which supplies buildings used for domestic purposes.

Complies

IEC 61000-3-3

Guidance and manufacturer’s declaration - electromagnetic immunity

The HFA3 is intended for use in the electromagnetic environment specified below

. The customer or user of the HFA3 should ensure that it is

used in such an environment

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

Electrostatic Discharge (ESD

) IEC 61000-4-2

± 6 kV contact ± 8 kV air

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

Electrical fast

ansient/burst

tr 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

± 2 kV common mode

Voltage dips, short in

terruptions, and voltage variations on power supply input lines. IEC 61000-4-11

(>95% dip in UT)

<5% U

for 0.5 cycle

(60% dip in UT) for

40% U

5 cycles

(30% dip in UT) for

70% U

25 cycles

(95% dip in UT)

<5% U

for 5 sec.

Power Frequency 

3 A/m 3 A/m Power frequency magnetic fields should be at levels (50/60 Hz) magnetic field IEC 61000-4-8

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

Note: U

± 2 kV for power supply lines ± 1 kV for input/output lines

± 1 kV differential mode ± 2 kV common mode

<5% U

(>95% dip in UT)

for 0.5 cycle

(60% dip in UT) for

40% U

5 cycles

(30% dip in UT) for

70% U

25 cycles

(95% dip in UT)

<5% U

for 5 sec.

Mains power quality should be that of a typical

cial or hospital environment.

commer

Mains power quality should be that of a typical

cial or hospital environment.

commer

Mains power quality should be that of a typical commer

cial or hospital environment. If the user of the HFA3 requires continued operation during power mains interruptions, it is recommended that the HFA3 be powered from an uninterruptible source.

acteristic of a typical location in a typical

char commercial or hospital environment.

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

d 1.17 P=

d 2.33 P=

Go to Contents Introduction

Guidance and manufacturer’s declaration - electromagnetic immunity

1-11

The HFA3 is intended for use in the electromagnetic environment specified below

. The customer or user of the HFA3 should ensure that it is

used in such an environment

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

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 V Portable and mobile RF communications equipment

should

be used no closer to any part of the HFA3, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2,5 GHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2,5 GHz

3 V/m

Recommended separation distance where P is the

ximum output power rating of the transmitter in

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

ermined by an electromagnetic site survey,

det should be less than the compliance level in each frequency range.

Interference may occur in the vicinity of equipment

ked with the following symbol:

mar

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

omagnetic 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 HFA3 is used exceeds the applicable RF compliance level above, the HFA3 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the HFA3.

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

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

1-12

Introduction Go to Contents

Recommended separation distances between portable and mobile RF communications equipment and the HFA3

The HFA3 is intended for use in an electromagnetic environment in which r the HFA3 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the HFA3 as recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter m

Rated maximum output power of

ansmitter W

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

For transmitters rated at a maximum output 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 objects and people.

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

d = 1.17

power not listed above, the recommended separation distance d in meters (m) can be estimated

omagnetic propagation is affected by absorption and reflection from structures,

adiated RF disturbances are controlled. The customer or the user of

d = 1.17

d = 2.33

Risks of Internet Connectivity

CAUTION: When connected to the Internet, the HFA3 instrument may be vulnerable to serious security risks, including viruses and worms that co 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.

uld disable your system or

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

Software Installation

(2) Software Installation

This section covers the installation instructions for the Humphrey® Field Analyzer 3 (HFA™3).

Contents Software Kit

The software kit contains two USB drives:

• The white USB drive with the “SW” label contains the software onto the HFA3.

• The blue USB drive with the “UD” instructions and the Instructions for Use. This content is for your reference and is not required for software installation.

label is the user documentation, including the installation

Steps to Upgrade Software

For all existing versions of HFA3 software, start with the following steps to upgrade the software:

1. Start the instrument and log in as a user with Administrator privileges.

the software update and is used for loading

2-1

2. Select the Settings icon located in the Tool bar at the top of the screen. The Settings screen will appear.

3. Record the software version number you are currently running.

HFA3 Installation Instructions 2660021166131 Rev. A 2018-11

2-2

Software Installation

4. Insert the white USB drive with the SW label, which contains the software update, in one of the HFA3 USB connections. Note:

If you get an error message during installation, please take a screenshot (Print Screen and save in a graphics application, such as Microsoft Paint) of the information, then call your local ZEISS customer service number, shown on the back of this manual.

5. Navigate to the Main screen will appear. Select Yes to start.

tenance screen and select Perform update... A confirmation

6. Select Yes to start the Update Wizard.

7. A popup screen appears with the update. Highlight the update and select Run.

HFA3 Installation Instructions 2660021166131 Rev. A 2018-11

Software Installation

CAUTION: From this point forward, please do not click on, or touch, the screen anywhere other than as instructed. Otherwise, you risk aborting installation pr

8. Follow the on-screen instructions through the rest of the software upgrade process. Note:

ogress.

2-3

• There may be brief sequences when the scree

for the next on-screen prompt.

• Do not touch the screen or type on the keyboard during the installation process

xcept as directed by the on-screen prompts.

• There may be screens that show a progress bar. Occasionally, the progress bar will

for several seconds, but the installation is still in progress.

stop

• There will be several prompts for going to th

Respond to these prompts by using the touchscreen or the cursor driven by the keyboard or external mouse.

9. Select Finish fr

om the InstallShield Wizard Complete screen.

n goes black for several seconds. Wait

e next step or confirming a step.

10.The background screen turns black. A message appears: You are about to be logged off. Please start the instrument after shutdown.

11.Click Close and wait for the instrument to shutdown.

12.Restart depending on the version:

• If you are upgrading from version 1.3.x.x or

pressing the Power button.

HFA3 Installation Instructions 2660021166131 Rev. A 2018-11

older- Turn the instrument ON by

2-4

Software Installation

• If you are upgrading from version 1.4.1.x - Installer signals the controller to restart

itself.

13.The instrument boots up and the screen may be black for sever the InstallShield Wizard screen appears again. Allow the installer to complete the software update.

14.T he In

stallShield Wizard Complete screen appears. Click Finish to exit to the Wizard.

al minutes. Wait until

15.Remove the USB drive from the HFA3 instrument. You may now safely run the updated HFA3 software.

HFA3 Installation Instructions 2660021166131 Rev. A 2018-11

Go to Contents Getting Started

(3) Getting Started

This chapter describes instrument features, general operation, and settings of the HFA3.

Instrument Overview

3-1

cбЦмкЙ=PJN=qЬЙ=ec^PУ=lйЙк~нзк=sбЙп

1 – Patient response button connection 4 – Touch screen 7 – Audio output

2 – Patient response button 5 – On/Off button 8 – Speaker

3 – Chin rest control 6 – USB connections (2)

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

3-2

Getting Started Go to Contents

cбЦмкЙ=PJO=qЬЙ=ec^PУ=pбЗЙ=m~еЙд=`дзлЙЗ

1 – Location Side Panel

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

12 3 4

Go to Contents Getting Started

3-3

cбЦмкЙ=PJP=qЬЙ=ec^PУ=pбЗЙ=m~еЙд=lйЙеЙЗ

1 – 12V Power Outlet 2 – Display Port 3 – USB Port

4 – Ethernet Port

cбЦмкЙ=PJQ=_~Ев=m~еЙд=pугДздл

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

3-4

Getting Started Go to Contents

cбЦмкЙ=PJR=qЬЙ=ec^P=У=cкзен=sбЙп

1 – Chin rest 3 – Visor handle

2 – Testing bowl 4 – Forehead rest

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

Go to Contents Getting Started

Model Features

For a full list of available test

Parameters".

Feature

830 840 850 860

Manual Kinetic No License

Custom Kinetic Patterns No License

Custom Static Patterns No Standard Standard Standard

patterns and strategies see Appendix (A), "Test Patterns &

Model

Standard Standard

3-5

DICOM OPV (Ophthalmic Visual Field)

Standard Standard Standard Standard

IOD (Information Object Definition)

OPV IOD Advanced Indices

License License License License

Remote Diagnostics and Software Loading Standard Standard Standard Standard

™

SITA

, STATPAC

SITA-SWAP

™

No No Standard Standard

Standard Standard Standard Standard

Stimulus Size I–V I–V I–V I–V

Auto Pupil Measurement No Standard Standard Standard

Stimulus Color White White, Red White, Blue, Red White, Blue, Red

Foveal Threshold No Standard Standard Standard

Gaze Tracking No Standard Standard Standard

Head Tracking No Standard Standard Standard

Vertex Monitor No No Standard Standard

™

GPA

Standard Standard Standard Standard

Liquid Trial Lens No No No Standard

™

RelEYE

Monitor No No Standard Standard

a. Available by license only in the U.S., but standard in the rest of the world. b. Available without license in Germany, Austria, Switzerland, and Japan.

External Keyboard

The HFA3 comes with a standard external keyboard and

trackpad combination. Plug input devices

into USB ports located on the operator and opposite sides of the instrument.

USB Devices

Use only NTFS formatted USB stor

age devices for backup.

CAUTION: Make sure your USB devices are secured against malware/viruses. Patient data on USB devices can become corrupted when

inserting into computers for backup or transfer. The use of anti-virus software on computers is recommended and is the responsibility of the user.

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

3-6

Getting Started Go to Contents

Surge Protectors

ZEISS recommends the use of surge protectors or UPS (Unin help isolate the HFA3 from power surges or fluctuations. Hospitals, instruments which consume large amounts of power, such as surgical lasers, especially should be careful to plug the HFA3 directly into a UPS or adequate surge protector.

Printers

The HFA3 is compatible with PostScript printers, including printers using a wireless USB adapter, or directly connected using the Ethernet port. Direct USB connection is not supported.

WARNING: If any external devices are connected to the instrument, the operator must ensure that the complete system con defined in IEC 60601-1.

Touch Screen

All functions can be performed by touching a command to press too hard against the screen. To deselect an item, touch on another area of the screen. To return to a previous screen, if applicable, select the Back button on the lower left side.

tinues to comply with the requirements

Screen Keyboard

The screen keyboard is used to fill out the text boxes. It appears automatically as soon as the cursor is inserted into a text box. Touch and hold a character to bring up a menu with all the special characters (umlauts, etc.) belonging to this character. Select the desired special character by tapping it. Not all characters on the keyboard will be associated with special characters.

Keyboard icons:

terruptible Power Supply) systems to

surgery centers, and offices with

shared network printers and wireless

button on the touch screen. Be careful not

Switches the keyboard layout from letters to numerals and special characters.

Switches the keyboard layout from numerals and special characters to letters.

Hides the screen keyboard.

Select a flag to switch the language of the keyboard.

Note: The right click key available on some external keyboards will enable or disable the screen keyboard, overriding the instrument setting. Moving the k the right click key again on the external keyboard will reverse the effect

Access Menu Options

To access the options offered through each screen, touch click on menu options again to make the options disappear.

eyboard slider back and forth or pressing

or click on an option to select it. Touch or

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

Go to Contents Getting Started

3-7

• Some menus are fields tagged with a down arrow (drop-down lists). To access menu options, touch or click on the bar. Select the bar again to close the menu.

• Grayed-out menu options or buttons are not available.

Using the External Keyboard and Mouse

You may also use the external keyboard to move from one selection to the next on the HFA3 screen

nd enter data.

Select the intended data field with the touch screen or a mouse:

•Use the Ta

• Hold the Shift k

• Arrow keys may be used to move the cursor within a data field.

Note: Selecting Ctrl + Alt + Delete on your keyboard will take you to the Windows lock screen. Select Cancel, or pr off in this screen, restart the instrument.

b key to move the highlight from one data field to another in a forward direction.

ey down while pressing the Tab key to move in the opposite direction.

ess the Esc button on the keyboard to return to the instrument screen. If you log

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

3-8

Getting Started Go to Contents

Title Bar

Title bar icons:

This icon appears if the Liquid Trial Lens is installed (Model 860 only) and flashes red during lens adjustment. Do not touch the Liquid Trial Lens when the icon is blinking.

Select the Private button to hide the screen from anyone who does not need to view patient data. Click the Continue button to return to the patient data.

Tap the Help button to open the on-screen user manual.

The Brightness button displays a control for adjusting the brightness.

Tap the Volume button to display a slide control for adjusting the volume.

The Settings button opens the Settings dialog window. See “Instrument Settings,” on

page 3-10. 

When there is a new alert, an exclamation point appears with the Settin Clicking on the exclamation point opens the Message history.

The Close button opens a menu with options for logging out the current user or switching off the device.

gs button.

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11

+ 126 hidden pages

Zeiss Humphrey Field Analyzer 3 840, Humphrey Field Analyzer 3 830, Humphrey Field Analyzer 3 850, Humphrey Field Analyzer 3 860 Instructions For Use Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

(1) Introduction

Operating Principles

Intended Use

Indications for Use

Patient Population

Part of the Body

Application

User Profile

Instrument Operation

Data Interpretation

Purpose of This User Manual

Models

Text Conventions

Electronic User Manual Access

Symbols and Labels

Safety Information

Protective Packing Symbols

Instrument Disposition

Disposal

Disposal of the Product within the European Union (EU)

User Changes to Software or Hardware

Approved Software

Instrument Installation

Care in Handling

Installation Requirements

HFA3 Licenses

Product Compliance

Product Safety

General Safety Guidelines

Warnings and Cautions

Electromagnetic Compatibility (EMC)

Risks of Internet Connectivity

(2) Software Installation

Contents Software Kit

Steps to Upgrade Software

(3) Getting Started

Instrument Overview

Model Features

External Keyboard

USB Devices

Surge Protectors

Printers

Touch Screen

Access Menu Options

Using the External Keyboard and Mouse

Title Bar