ZEISS Humphrey Field Analyzer 3 (HFA3) Models 800 series Instructions for Use

Copyright ©2014 Carl Zeiss Meditec, Inc. All rights reserved.

Trademarks FastPac, FORUM, Guided Progression Analysis, GPA, Humphrey, HFA, SITA, SITA Fast, 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.meditec.zeiss.com/patents

i 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 Instrument Disposition... 1-5 Disposal... 1-5 User Changes to Software or Hardware... 1-5 Instrument Installation... 1-6 HFA3 Licenses... 1-6 Product Compliance... 1-6 Product Safety... 1-6 Electromagnetic Compatibility (EMC)... 1-9 (2) Operation... 2-1 Instrument features... 2-1 External Instrument Components... 2-4 General Operation... 2-5 Settings... 2-7 (3) Setup and Testing... 3-1 Perform Threshold or Suprathreshold Test... 3-1 Perform Kinetic Test... 3-11 Create Custom Test Patterns... 3-18 Set up Test Profiles... 3-20 Delete Test Profiles and Patterns... 3-20 (4) Managing Data, Tests, and Reports... 4-1 Manage Data and Tests... 4-1 Static Threshold Reports... 4-4 Report Features... 4-9 Suprathreshold Reports... 4-12 Kinetic Reports... 4-13 (5) Networking... 5-1 Network Capabilities... 5-1 Configuration to a Pre-existing Office Network... 5-1

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ii Connect to a DICOM Server... 5-2 Connect to a Printer... 5-4 (6) Maintenance... 6-1 Cleaning the instrument... 6-1 Replacing the Stimulus Projection Lamp... 6-2 Calibrate AutoTLC using a Lens Analyzer... 6-4 Accessories and Supplies List... 6-5 (7) Data Transfer from an HFA II or HFA II-i... 7-1 Set up a Data Transfer... 7-1 (8) Specifications... 8-1 HFA3 Instrument... 8-1 (A) Test Patterns and Parameter Settings...A-1 Threshold Test Patterns... A-1 Suprathreshold Test Patterns... A-3 Test Parameters... A-8 (B) Determine the Trial Lens...B-1 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 Software License Agreement... D-1

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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.

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. The Carl Zeiss Meditec, Inc. Guided Progression Analysis™ (GPA™) is a software analysis module for the Humphrey Field Analyzer that assists practitioners with the detection, measurement, and management of progression of visual field loss. It aids in assessing change over time, including change from baseline and rate of change. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, glaucoma. Note: 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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1-2

Introduction 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 (8), "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 • 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

Occupational Skills The user should have the following skills:

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Introduction 1-3 • 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. Models This guide contains instructions for Models 830, 840, and 850, and 860. Licensed software and various hardware upgrades differentiate models. See Model Features on page 2-3. 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 CD included in the instrument accessory kit. If necessary, go to www.adobe.com to download and install the free Adobe Reader.

Symbols and Labels WARNING

CAUTION

Must Follow Instructions For Use.

DisplayPort®

USB Port

Network Port

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1-4

Introduction

Power Switch

Type B applied parts

Patient Response Button

Headphones Direct Current Alternating Current CAUTION: Hot Surface

Manufacturer

Date of Manufacture

Serial number

Catalog number / part number Model number Patent

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

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.

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Introduction 1-5 Handling Requirements

Transport (Packaged)

Fragile, Handle with Care

Humidity (10% to 95%)

Keep Dry

Temperature (–40 to +70 deg. C)

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 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.

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1-6

Introduction 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.

Instrument Installation Only an authorized ZEISS service representative should install the HFA3. In consultation with the buyer, ZEISS 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 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 (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.

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

Product Compliance

Complies with US and Canadian medical electrical system safety requirements.

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.

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Introduction 1-7 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. • 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 AutoTLC, 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.

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1-8

Introduction WARNING: If the instrument is externally connected to AC powered, 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 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. 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 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 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.

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Introduction 1-9 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

RF emissions CISPR 11

Group 1

RF emissions CISPR 11

Class B

The HFA3 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions

Complies

The HFA3 is suitable for use in all establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

HFA3 Instructions for Use

Electromagnetic environment - guidance 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.

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Introduction

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

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

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Introduction 1-11 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 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 d = 1.17 P 150 kHz to 80 MHz d = 1.17 P 80 MHz to 800 MHz d = 2.33 P 800 MHz to 2,5 GHz

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3V

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2,5 GHz

3 V/m

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:

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

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Introduction

1-12

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

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

1

1.170

1.170

2.330

10

3.700

3.700

7.368

100

11.700

11.700

23.300

W

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.

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 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.

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Operation 2-1 (2) Operation This chapter describes instrument features, general operation, and settings of the HFA3.

Instrument features

4

3 5 6 7 8

2

1 cáÖìêÉ=OJN=qÜÉ=ec^PÓ=léÉê~íçê=páÇÉ=sáÉï 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)

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2-2

Operation

3

4

2 5

1

cáÖìêÉ=OJO=qÜÉ=ec^P=Ó=oÉ~ê=sáÉï 1 – Cable routing access

3 – Service access

2 – Model and serial number

4 – Air filter access

5 – External device connections

3 2

4

1

5 6

cáÖìêÉ=OJP=bñíÉêå~ä=ÇÉîáÅÉ=ÅçååÉÅíáçåë=~åÇ=éçïÉê=áåéìí= 1 – 12V

power outlet

2 – Display port

HFA3 Instructions for Use

3 – Power input

5 – Ethernet port

4 – USB ports (4)

6 – Startup codes display

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Operation 2-3

4 3

2 1

cáÖìêÉ=OJQ=qÜÉ=ec^P=Ó=cêçåí=sáÉï= 1 – Chin rest

3 – Visor handle

2 – Testing bowl

4 – Forehead rest

Model Features Model Feature

830

840

850

860

Manual Kinetic

No

Standard

Standard

Standard

Custom Kinetic Patterns

No

Standard

Standard

Standard

Custom Static Patterns

Standard

Standard

Standard

Standard

DICOM OPV IODa

License

License

License

License

Remote Diagnostics and Software Loading

Standard

Standard

Standard

Standard

SITA™, STATPAC™

Standard

Standard

Standard

Standard

SITA-SWAP™

No

No

Standard

Standard

Stimulus Size

I–V

I–V

I–V

I–V

Auto Pupil Measurement

No

No

Standard

Standard

Stimulus Color

White

White, Blue, Red

White, Blue, Red

White, Blue, Red

Foveal Threshold

No

Standard

Standard

Standard

Table 2-1

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Operation

2-4

Model Feature

830

840

850

860

Gaze Tracking

No

Standard

Standard

Standard

Head Tracking

No

No

Standard

Standard

Vertex Monitor

No

No

Standard

Standard

Custom Static Tests

No

Standard

Standard

Standard

GPA™

Standard

Standard

Standard

Standard

Auto-Trial Lens Correction (AutoTLC)

No

No

No

Standard

RelEYE™ Monitor

No

No

Standard

Standard

Table 2-1 a. Available by license only except in Germany, Austria, Switzerland and Japan.

External Instrument Components 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

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. Surge Protectors ZEISS recommends the use of surge protectors or UPS (Uninterruptible Power Supply) systems to help isolate the HFA3 from power surges or fluctuations. Hospitals, surgery centers, and offices with 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 shared network printers and wireless printers using a wireless USB adapter. If your printer supports a USB connection you may also directly connect your PostScript printer to the instrument using the appropriate port. WARNING: 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.

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