Zeiss Humphrey Field Analyzer 3 User manual

2660021166131 Rev. A 2018-112660021166131 Rev. A 2018-11
Humphrey®Field Analyzer 3 (HFA3)
Instructions for Use – Models 830, 840, 850, 860

HFA3 Instructions for Use 2660021166131 Rev. A 2018-11
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Copyright
©2018 Carl Zeiss Meditec, Inc. All rights reserved.
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

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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
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

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(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

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Guidelines for Trial Lens Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
How to Calculate the Spherical Equivalent . . . . . . . . . . . . . . . . . . . . . . . . . B-1
(C) Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-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

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HFA3 Instructions for Use 2660021166131 Rev. A 2018-11
Go to Contents Introduction 1-1
(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 perimetry that emulates
manual standard Goldmann perimetry. You can manually select kinetic isopters, or perform custom
scans automatically or step by step.
Intended Use
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 age of six in need of diagnostic
evaluation of the eye. This includes (but is not limited to) patients with the following disabilities or
challenges:
• Wheelchair user
• Very low or not measurable visual acuity
• Postural problems
• Fixation problems
• Deafness
• Large body, but not those above 99th percentile based on anthropomorphic data
There is a general requirement that the patient be able to sit upright and be able to place his or her
face on the chin and forehead rest of the instrument (with or without supplemental human or
mechanical support).
Part of the Body
The HFA3 physically interacts with the patient’s forehead and chin. The patient's hand and fingers
(or similar ability) are also required to press the patient response button.

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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 Chapter (12), "Specifications".
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
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
•Archivedata
• Power off the instrument
Data Interpretation
Demographic
The user should be one of the following:
• Ophthalmologist or other Medical Doctor
• Optometrist or equivalent

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Go to Contents Introduction 1-3
Occupational Skills
The user should have the following skills:
•SeeInstrument 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 in the instructions for use.
Models
This guide contains instructions for Models 830, 840, 850, and 860. Licensed software and various
hardware upgrades differentiate models. See Model Features on page 3-5.
Text Conventions
The terms “select,” “choose,” “touch,” “press,” and “tap” each mean to initiate an operator action
using the touch screen, external keyboard, or mouse.
This manual means “left-click” when it says “click,” except where “right-click” is specified.
Electronic User Manual Access
The HFA3 User Manual, created in Acrobat PDF format for use on a computer, is provided on the
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.

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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

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Go to Contents Introduction 1-5
Safety Information
Warning: Indicates a hazardous situation which may result in death or serious injury if the
appropriate safety precautions are not heeded.
Caution: Indicates a hazardous situation which may result in minor or moderate injury or damage to
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
transport 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.
Date of Manufacture
Authorized European Community Representative
Serial number
Catalog number / part number
Model number
Patent
European Conformity
Disposal of the Product within the EU. Do not dispose via domestic waste disposal
system or communal waste disposal facility.
Handling Requirements Transport (Packaged)
Fragile, Handle with Care Humidity (10% to 95%)
Keep Dry Temperature (–40 to +70 deg. C)

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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 future relocation or repair.
If you wish to dispose of the packaging material, contact a recognized collection system for
recycling.
The device contains electronic components. At the end of its lifetime, the product and its integrated
batteries should be disposed of in accordance with the relevant national regulations.
In accordance with applicable EU guidelines and national regulations at the time at which the
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 contact your local dealer or the
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 is
to be disposed of in accordance with the currently applicable national regulations.
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 the 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 HFA3 is authorized. For the current list of
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.
This end up Atmospheric Pressure Limits (500 hPa to
1060 hPa)

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Go to Contents Introduction 1-7
Instrument Installation
An authorized ZEISS service representative or the owner/operator can install the HFA3 . In consultation
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
contains fragile optics that have been precisely aligned at the factory.
Installation Requirements
• The HFA3 should be connected to a dedicated power outlet. The HFA3 will operate within its
specifications when connected to any AC main supply in the range 90 to 264Vac, 47Hz to
63Hz.
• An isolation transformer is required when connecting peripheral devices that are not Medical
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.
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 according 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).
•Ordinary Equipment (IPX0) – Degree of protection against ingress of liquids (none).
•Continuous 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
service technician. Failure to do so
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
liquids (classified IPXO—ordinary equipment). Do not place containers of liquid on or near the
instrument, nor use aerosols on or near it.

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1-8
• 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™, patient response button, external
keyboard, and fan filter are all user-replaceable parts. For the replacement of any other
instrument component, accessory, or peripheral, call ZEISS
Customer Care: In the U.S., call
800-341-6968. Outside the U.S., contact your local ZEISS distributor.
• Although this instrument is designed for continuous operation, it should be turned off when
not in use for an extended period.
• This instrument operates according to specifications under standard indoor office (fluorescent)
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
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 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 socket 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.
WARNING: If the instrument is externally connected to AC powered, non-medical
peripheral devices (for example; printers, storage devices), 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 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 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 touch the patient and the peripheral device
simultaneously.

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Go to Contents Introduction 1-9
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 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
external 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 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 or oxidizers such as nitrous
oxide or pure oxygen.
WARNING: Avoid tipping. Do not use the instrument on an uneven or sloped
surface. Do not roll the table from one location to another while the instrument is
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.
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 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 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 to verify normal operation in the configuration in which it will
be used.

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. Therefore, its RF emissions are very
low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11
Class A The HFA3 is suitable for use in all
establishments other than domestic
establishments and those connected to a low
voltage power supply network which supplies
buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Complies
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
± 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
transient/burst
IEC 61000-4-4
± 2 kV for power supply
lines
± 1 kV for input/output
lines
± 2 kV for power supply
lines
± 1 kV for input/output
lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge IEC 61000-4-5 ± 1 kV differential mode
± 2 kV common mode
± 1 kV differential mode
± 2 kV common mode
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions, and voltage
variations on power supply
input lines. IEC 61000-4-11
<5% UT(>95% dip in UT)
for 0.5 cycle
40% UT(60% dip in UT) for
5 cycles
70% UT(30% dip in UT) for
25 cycles
<5% UT(95% dip in UT)
for 5 sec.
<5% UT(>95% dip in UT)
for 0.5 cycle
40% UT(60% dip in UT) for
5 cycles
70% UT(30% dip in UT) for
25 cycles
<5% UT(95% dip in UT)
for 5 sec.
Mains power quality should be that of a typical
commercial 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.
Power Frequency 
(50/60 Hz) magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
Note: UTis the a.c. mains voltage prior to application of the test level.
Introduction Go to Contents
HFA3 Instructions for Use 2660021166131 Rev. A 2018-11
1-10

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
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:
d1.17 P=
150 kHz to 80 MHz
d1.17 P=
80 MHz to 800 MHz
d2.33 P=
800 MHz to 2,5 GHz
Recommended separation distance where P is the
maximum output power rating 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 by an electromagnetic site survey,a
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of equipment
marked with the following symbol:
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2,5 GHz
3 V/m
Note 1: At 80 MHz and 800 MHz, the higher frequency applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
aField 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.
bOver 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
Go to Contents Introduction 1-11

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 radiated RF disturbances are controlled. The customer or the user of
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.
Rated maximum output power of
transmitter W
Separation distance according to frequency of transmitter m
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
d = 1.17
P
d = 1.17
P
d = 2.33
P
0,01 0.117 0.117 0.233
0,1 0.370 0.370 0.737
11.170 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 power not listed above, the recommended separation distance d in meters (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. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
Introduction Go to Contents
HFA3 Instructions for Use 2660021166131 Rev. A 2018-11
1-12
Risks of Internet Connectivity
CAUTION: When connected to the Internet, the HFA3instrument may be vulnerable to
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.

HFA3 Installation Instructions 2660021166131 Rev. A 2018-11
Software Installation 2-1
(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 update and is used for loading
the software onto the HFA3.
• The blue USB drive with the “UD” label is the user documentation, including the installation
instructions and the Instructions for Use. This content is for your reference and is not required
for software 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.
2. Select the Settings icon located in the Toolbar at the top of the screen. The Settings
screen will appear.
3. Record the software version number you are currently running.

Software Installation
HFA3 Installation Instructions 2660021166131 Rev. A 2018-11
2-2
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 Maintenance screen and select Perform update... A confirmation
screen will appear. Select Yes to start.
6. Select Yes to start the Update Wizard.
7. A popup screen appears with the update. Highlight the update and select Run.