Carl Zeiss Meditec Humphrey Field Analyzer II-i series User Manual Sw ver 5.1 Rev A

Copyright © 2010 Carl Zeiss Meditec, Inc. All rights reserved.

Trademarks EasyConnect, FastPac, FORUM, GPA, Humphrey, HFA, HFA-NET Pro, SITA, SITA Fast, SITA Standard, and SITA-SWAP, are either registered trademarks or trademarks of Carl Zeiss Meditec, Inc. in the United States and/or other countries. Windows and Windows Server are registered trademarks of Microsoft Corporation in the United States and/or other countries. Bonjour, the Bonjour logo, and the Bonjour symbol are trademarks of Apple Computer, Inc. HP, LaserJet, PCL, and DeskJet are registered trademarks of Hewlett-Packard Company. VxWorks is a registered trademark of Wind River Systems, Inc. All other trademarks used in this document are the property of their respective owners.

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Applicability This document applies to the HFA II-i series instrument, System Software Version 5.1 or higher, unless superseded.

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Contents i Contents (1) Introduction & Instrument Setup...1-1 •Intended Use ...1-1 •Indications for Use...1-1 •Purpose of This User Manual... 1-4 •Symbols ... 1-5 •Instrument Disposition ... 1-9 •Disposal... 1-9 •WARNING: User Changes to Software or Hardware ... 1-9 •Instrument Installation ... 1-9 •Tips to Avoid Damage...1-10 •HFA II-i Embedded License ...1-10 •Product Compliance...1-11 •Product Safety ...1-11 •Electromagnetic Compatibility (EMC) ... 1-12 •Accessory Equipment... 1-15 •About Visual Fields ... 1-16 •The Humphrey Advantage ... 1-19 •System Components ... 1-22 •Additional Components ...1-24 •System Assembly ... 1-30 (2) General Operation... 2-1 •General Information ... 2-1 •Using the File Directory ...2-8 •The Main Menu Screen ...2-9 •System Setup ... 2-10 •Additional Setup...2-30 •Help Screens ...2-32 (3) Setting-Up Tests ... 3-1 •Selecting the Test Pattern and Test Eye... 3-1 •Entering Patient Data ... 3-7 •Using Trial Lenses ...3-20 •Preparing the Patient... 3-24 (4) Test Parameters and Strategies ... 4-1 •Setting Test Parameters ... 4-1 •Test Strategies ...4-4 •SITA Testing ... 4-10 (5) Testing ... 5-1 •Start Test Options ...5-2 •Monitoring and Maintaining the Patient’s Eye Position ...5-3 •Supplemental Testing ... 5-7

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Contents •Test in Progress... 5-10 •Fixation Monitoring... 5-11 •Tips for Gaze Tracking and Head Tracking ...5-13 •Test Complete Screen Options ...5-13 •Testing: A Step-by-Step Guide ...5-16 (6) Test Reliability... 6-1 •Factors Affecting Reliability...6-2 •Evaluating Reliability...6-4 (7) STATPAC Analysis & Printing... 7-1 •Introduction To STATPAC Analysis ... 7-2 •Threshold Test Printout Formats ... 7-3 •Printing Current Threshold Test Results ...7-16 •Screening Printout Formats ...7-16 •Printing Current Screening Test Results ...7-18 •Printing Previously Saved Test Results ...7-19 •Grayscale Symbols ... 7-21 (8) Guided Progression Analysis (GPA) ... 8-1 •Introduction to GPA ...8-2 •Overview of GPA Reports...8-4 •Understanding GPA Reports ... 8-10 •Establishing the GPA Baseline ...8-12 •Clinical Interpretation of GPA Results...8-13 •GPA Case Studies...8-15 •How To Print GPA Reports ...8-29 •How to Activate GPA Software on the HFA II-i ...8-35 (9) Short-Wavelength Automated Perimetry (SWAP)... 9-1 •Introduction to Short-Wavelength Automated Perimetry ... 9-1 •SITA-SWAP Testing ...9-3 •Printing Out SITA-SWAP Results ...9-8 •SITA-SWAP Case Studies ... 9-10 •Licensing SITA-SWAP on Your HFA ...9-14 (10) File Functions...10-1 •File Functions Menu ... 10-2 •Retrieving the File Directory ... 10-4 •Selecting Tests from the File Directory ... 10-9 •Performing File Functions...10-13 •Serial Transfer of Tests Between HFA I, HFA II or HFA II-i Instruments...10-19 •Organizing Patient Files... 10-24

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Contents iii (11) Database Management ...11-1 •Introduction to Database Management... 11-2 •Patient Database Protection Procedures... 11-3 •Configuration Back Up and Restore... 11-5 •How to Handle Database Failures ...11-10 •Merging Databases ... 11-22 •Cleanup Hard Disk Database ... 11-23 •Care and Handling of Removable Storage Media ... 11-24 (12) Custom Testing ...12-1 •Creating Custom Tests ...12-1 •Deleting Custom Tests ...12-13 •Performing Custom Tests ...12-16 •Printout Formats... 12-17 (13) Kinetic Testing ...13-1 •Introduction to Kinetic Testing... 13-2 •Performing Kinetic Perimetry Manually ... 13-3 •Pre-Defined Kinetic Test Patterns...13-13 •Running Automated Kinetic Tests...13-14 •Social Security Administration Kinetic Disability Test ... 13-24 •Special Mapping... 13-27 •Viewing Kinetic Tests ... 13-39 •Printing Kinetic Tests ... 13-43 •Designing a Custom Kinetic Test Pattern ... 13-48 •Creating the Aphakic SSA Disability Test ... 13-56 (14) Networking ...14-1 •Chapter Organization ... 14-2 •Network Configurations ... 14-3 •An Overview of HFA-NET Pro ... 14-5 •How to Use the HFA’s Networking Features ...14-13 •Backing Up Data to the Server...14-14 •Restoring Data from the Server ...14-16 •Synchronizing Databases on Two or More HFA II-i Perimeters...14-18 •Using Patient Folders... 14-25 •Transferring Tests... 14-30 •Using the Save/Transmit Option... 14-33 •Printing To a File... 14-36 •Using an EMR/PMS/DICOM System ... 14-38 •Exporting to EMR/PMS/DICOM Systems ... 14-41 •Importing Work Lists from Non-DICOM EMR/PMS Systems and DICOM Systems using DICOM Gateway 1.0... 14-45 •Importing Work Lists from DICOM Systems using DICOM Gateway 2.0 . 14-48 •Recall Patients, View, or Print Tests from a DICOM Archive  (DICOM Gateway 2.0 only) ... 14-53

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iv •Imported Patient Rules and Conflicts ... 14-58 (15) Care and Cleaning ...15-1 •General Use Principles ... 15-2 •Cleaning the HFA II-i... 15-2 •Replacing Parts... 15-4 •Operating the Printrex Printer ... 15-9 •Touch Screen Calibration ...15-11 •Using Removable USB Storage Devices and Floppy Disks...15-12 (A) Product Specifications... A-1 (B) Product Features ... B-1 (C) Legal Notices... C-1 (D) Icon Glossary ...D-1 (E) Goldmann Conversion Tables... E-1 •Conversion Table for Blue-Yellow ... E-5 •Blue-Yellow Specifications ... E-6 (F) Test Patterns... F-1 •Screening Test Patterns... F-1 •Threshold Test Patterns... F-4 •Specialty Tests Patterns ... F-6 (G) EasyConnect RCT 1.0 ...G-1 •Overview...G-1 •Before You Run the RCT ... G-2 •Enable the RCT and Name HFA II-i Instruments... G-3 •Launch the RCT... G-4 •Easy Mode (default)... G-6 •Copy Mode ... G-14 •Custom Mode ... G-20 •Report Mode...G-31 •Test Mode ... G-35 •Troubleshooting... G-43 (H) DICOM Gateway 2.0 (Optional) ...H-1 •Overview...H-1 •DICOM Gateway 2.0 Configuration Overview... H-2 •HFA II-i Configuration... H-2

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Networking Reference... I-1 •Licensing HFA-NET Pro and DICOM Gateway 2.0... I-1 •Connecting Your Network Components ...I-3 •Setting Up Your HFA Network...I-4 •File Server Access Protocol for FTP or Shared Folder ...I-8 •Archiving Data... I-14 •Setting Up Save & Transmit to a Network File Server... I-21 •Setting Up Exporting to Non-DICOM EMR/PMS Systems and DICOM Systems using DICOM Gateway 1.0...I-22 •Setting Up Work Lists for Non-DICOM EMR/PMS Systems and DICOM Systems using DICOM Gateway 1.0...I-23 •Setting Up Save & Transmit for EMR/PMS/DICOM Systems... I-24 •Setting Up Printing To a File ...I-25 •Backing Up and Restoring Your HFA Network Configuration... I-27 •Network Diagnostics ...I-28 •Network Troubleshooting Error Messages ... I-31 •DICOM Networking Error Messages ... I-37 •Networking Terminology ...I-38 •Serial Communications Protocols Used by HFAs ...I-40

(J) Installing & Licensing HFA II-i Software ...J-1 •System Software Installation ...J-2 •Installing Additional Software ...J-3 •Licensing GPA, SITA-SWAP, HFA-NET Pro, or DICOM Gateway 2.0 ...J-5 (K) SITA Normative and GPA Databases... K-1 •How SITA Works ... K-1 •Normative and GPA Database Collection and Demographics ...K-3 •Acknowledgements ...K-8 (L) Reference to Older Test Strategies ...L-1 (M) Troubleshooting ... M-1 •Accessories and Supplies List ...M-8 Index ... N-i

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Introduction & Instrument Setup 1-1 (1) Introduction & Instrument Setup Intended Use

1-1

Purpose of This User Manual

1-4

Symbols

1-5

Instrument Disposition

1-9

Disposal

1-9

Instrument Installation

1-9

Tips to Avoid Damage

1-10

Product Compliance

1-11

Product Safety

1-11

Electromagnetic Compatibility (EMC)

1-12

Accessory Equipment

1-15

About Visual Fields

1-16

The Humphrey Advantage

1-19

System Components

1-22

Additional Components

1-24

System Assembly

1-30

You are about to use the most advanced automated perimeter available, the Humphrey® Field Analyzer II-i series (HFA™ II-i ). This introductory section covers general information about the HFA II-i, including a brief discussion of visual fields and a summary of important instrument features. After reading this chapter you will be familiar with: • the importance of visual field testing • general principles of perimetry • unique features of the HFA II-i • installation and safety precautions • connecting the printer and optional external devices

Intended Use The Carl Zeiss Meditec, Inc. Humphrey Field Analyzer II-i is an automatic perimeter which is intended to be used to measure the visual field of the eye.

Indications for Use The Humphrey Field Analyzer II-i is an automated perimeter intended to identify visual field defects for the purposes of screening, monitoring and assisting in the diagnosis and management of ocular diseases such as glaucoma, and related neurological disorders.

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Note: These perimetry results are an aid to interpretation, not a diagnosis. The doctor’s judgment is still the most important element in determining the clinical significance of the results, including considering the limitations of the statistical package.

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Introduction & Instrument Setup Patient Population The Humphrey Field Analyzer II-i may be used on all adults and children over the age of six in need of diagnostic evaluation of the eye. This includes (but is not limited to) patients with the following disabilities or challenges: • Wheelchair user • Very low or not measurable visual acuity • Postural problems • Fixation problems • Deafness • Large body, but not those above 99th percentile based on anthropomorphic data There is a general requirement that the patient be able to sit upright and be able to place their face in the chin and forehead rest of the instrument (with or without supplemental human or mechanical support). Part of the Body The Humphrey Field Analyzer II-i physically interacts with the patient’s forehead and chin. The patient's hand and fingers (or similar ability) are also required to press the Patient Response button. Application The Humphrey Field Analyzer II-i is designed for continuous use, although it is expected that most sites operate the instrument for 10 hours or less per day, indoors, within a medical office or hospital setting. This setting shall have clean air free of soot, vapors from adhesives, grease, or volatile organic chemicals. Other Operating Environment specifications are given in Appendix (A), "Product Specifications,". Application related warnings are given in Chapter (1), "Introduction & Instrument Setup," and elsewhere. User Profile We assume that users are clinicians with professional training or experience in the use of ophthalmic equipment, and in diagnostic interpretation of the test results. Specific assumptions regarding the profiles of individuals performing instrument operation or data interpretation are given below. This manual contains information that will aid in the proper instrument operation and interpretation of the resultant data. Instrument Operation Demographic The user should be adult, and at least one of the following: • Ophthalmologist • Optometrist • Nurse • Certified Medical Technician • Ophthalmic Photographer • Non-certified Assistant

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Introduction & Instrument Setup 1-3 Occupational Skills The user should be able to perform all of the following tasks: • Power on the instrument • Enter, find, and modify patient identifying data • Clean surfaces that contact patient • Position patient with the instrument, including moving the 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: • See Instrument Operation above • 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.

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Purpose of This User Manual Carl Zeiss Meditec designed this User Manual to serve as a training, usage and reference guide. While we offer training in the use of the HFA II-i, we do not offer instruction in diagnostic interpretation. This manual does not attempt to do so. To fully appreciate the capabilities of the HFA II-i and to develop good testing techniques, we recommend that you rely on this User Manual as your training and reference guide. It has been designed to make learning easy. The concise step-by-step instructions and accompanying illustrations help you get started quickly and with more confidence. We think you will enjoy working with the HFA II-i. The friendly touch control makes it inviting to learn and easy to operate. For optimum results: • Read your User Manual in the order written. • Read it while sitting at the instrument. • Practice using the HFA II-i by first testing staff members, before using it with patients.

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Note: HFA II-i series system software Ver. 5.x has updated the style of the user interface without altering the button locations, functions, and text from the prior software version. This manual depicts the screens in the prior software style. Regardless of style, text and buttons on screen images depicted in this manual are identical to those in the Ver. 5.x software screen images. Model Differentiation This guide contains instructions for Models 720i, 740i, 745i and 750i. Although much of the information is relevant to all models, some information applies only to particular models. When a feature or function applies only to specific models, this guide specifies the model number(s), often in parentheses, in a prominent location. An example of this is found in the discussion of “SWAP (Blue-Yellow) Testing (Models 745i and 750i),” on page 1-20. Conversely, model numbers are not specified when information is standard or optional on all models. You can find the model number of your instrument on the rear panel of the HFA II-i or you may access this information via the “i” button located in the upper, left-hand corner of the screen (see “The Information Button,” on page 2-3). Refer to Appendix (B), "Product Features,", if you are unsure about the particular capabilities of your instrument. Text Conventions The terms “select,” “choose,” “touch,” and “press” are used interchangeably. Each term means to initiate an operator action using the touch screen, external keyboard, glidepad, trackball, or mouse. The terms “hard disk” and “hard drive” are used interchangeably, in reference to the data storage device standard on all HFA II-i models. UPPER CASE LETTERS are reserved for references to specific command buttons found on the touch screen. The exceptions to this are messages on test printouts, the words STATPAC, SITA™, SWAP, HFA II-i, and headings.

Italicized words are used to identify the icon buttons on the right border of the screen, the titles of figures, pictures, tables, and special notes in this manual.

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Introduction & Instrument Setup 1-5 Bold words are used to highlight warnings and section headings. This manual means “left-click” when it says, “click,” except where “right-click” is specified. Chains of menu items are indicated with the use of the “>” symbol between items. For example, “File>Exit” directs you to select Exit in the File menu. Access Menu Options To access the options offered through each menu, click on the menu headings. Then click on an option to select it. Click outside all menu options to make the options disappear. • Some menus are fields tagged with a down-arrow (drop-down lists). To access these menu options, click on the down-arrow. • Grayed-out menu options or buttons are not available. Electronic User Manual Access The HFA II-i User Manual in Acrobat PDF format for use on a computer is on the HFA II-i User Documentation CD included in the instrument accessory kit. If you do not have Adobe Reader installed, go to www.adobe.com to download and install the free Adobe Reader. Additional References The User Manual cannot possibly cover every situation you may encounter with the HFA II-i, especially interpretation questions. Your HFA II-i comes with a copy of Essential Perimetry, which provides an overview of visual field results. Automated Static Perimetry, Second Edition, by Douglas R. Anderson and Vincent Michael Patella (Mosby, Inc., St. Louis), is recommended for in-depth information and analysis of visual fields.

Symbols Caution, consult accompanying documents. Note: There are important operating and maintenance instructions found in the manual.

Presence of electrical shock hazard. Note: Indicates risk of electrical shock due to the presence of uninsulated high voltage inside the instrument. Do not remove the instrument cover or parts.

Fuse

Type B applied parts

Manufacturer

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Date of Manufacture

Authorized European Community Representative

Serial number

Catalog number / part number

European Conformity 0297 Model

Patent

System Software USB Flash Drive

Calibration Software USB Flash Drive GPA Sample Data USB Flash Drive

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Introduction & Instrument Setup 1-7 Additional symbols appearing on the HFA II-i: Power On Projector Lamp

Power Off

Brightness VGA Video Port

Air Intake Filter

Serial RS-232 Communication Port

Printer

USB Port

Keyboard/Mouse Port

Network Port

Patient Response Button

DO NOT USE

Figure 1.1 : Additional HFA II-i Symbol Definitions

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Introduction & Instrument Setup Protective Packing Symbols The protective packing symbols on the shipping carton specify the handling requirements and the transport and storage conditions for the HFA II-i as it is shipped from the factory. Note these symbols in the event that your HFA II-i must be stored for a period of time, prior to its set up and use. Handling Requirements Fragile

Keep Dry

This end up

Transportation and Storage Conditions Relative Humidity: 10% to 100%, including condensation

Temperature: -40 to +70 deg. C Atmospheric Pressure: 500 hPa to 1060 hPa

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Introduction & Instrument Setup 1-9 Instrument Disposition When it comes time to upgrade the HFA, please contact Carl Zeiss Meditec to inquire about trade-in or upgrade values we may offer. Should you not wish to trade in the instrument, please see the Disposal section below.

Disposal This product contains electronic components. At the end of its lifetime, the product should be disposed of in accordance with the relevant national regulations. Disposal of the Product within the European Union (EU) In accordance with applicable EU guidelines at the time at 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 must be disposed of in accordance with the currently applicable national regulations.

WARNING: User Changes to Software or Hardware The HFA II-i is a medical device. The software and hardware have been designed in accordance with U.S., European and other international medical device standards designed to protect clinicians, users and patients from potential harm caused by mechanical, diagnostic or therapeutic failures. Unauthorized modification of HFA II-i 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 Use of software supplied or approved by Carl Zeiss Meditec for the HFA II-i is authorized. For the current list of approved software call Carl Zeiss Meditec Customer Care: In the U.S., call 800-341-6968. Outside the U.S., contact your local Carl Zeiss Meditec distributor.

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

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

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Care in Handling Use extreme care when handling and transporting the HFA II-i shipping boxes. The instrument contains fragile optics that have been precisely aligned at the factory. Installation Requirements • The HFA II-i should operate on a dedicated power outlet. Based on your specification, we configure your HFA II-i at the factory to use either 100V, 115V, or 230V line voltage. • 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.

Tips to Avoid Damage

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Note: Users are not authorized to dismantle or modify the HFA II-i hardware. To transport the instrument outside the office, you must consult with a Carl Zeiss Meditec service technician. Failure to do so voids all warranties offered with the HFA II-i. • Only Carl Zeiss Meditec authorized technicians should disassemble or service this instrument. In the case of malfunction, error messages or operational problems, call Carl Zeiss Meditec Customer Care: In the U.S., call 800-341-6968. Outside the U.S., contact your local Carl Zeiss Meditec distributor. • 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 wall outlet and call for service immediately. • With the exception of the main power fuses and keyboard, there are no user-replaceable parts in the instrument. For the replacement of any component, accessory, or peripheral, except fuses or the keyboard, call Carl Zeiss Meditec Customer Care: In the U.S., call 800-341-6968. Outside the U.S., contact your local Carl Zeiss Meditec distributor. • Although this instrument is designed for 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.

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

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Introduction & Instrument Setup 1-11 Product Compliance Complies with 93/42/EEC Medical Device Directive. 0297 Complies with US and Canadian medical electrical system safety requirements.

Product Safety • IEC 60601-1 • UL 60601-1 • CSA C22.2 No. 601.1-M90 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). • Ordinary Equipment (IPX0)– Degree of protection against ingress of liquids (none). • Continuous Operation – Mode of operation. General Safety Requirements • Although the HFA II-i is designed for continuous operation, it should be turned off when not used for an extended period of time. The HFA II-i should be used in a cool, dry dust-free setting. • Use the instrument cover to protect the HFA II-i at all times when it is not in use. • Do NOT place the cover over the instrument when the HFA II-i 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. • Use only a stand or table recommended by Carl Zeiss Meditec. Warnings 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 Carl Zeiss Meditec service representative may install the instrument. WARNING: Do not use the printer or the instrument or the optional power table with an extension cord or a power strip (multiple portable socket outlet). For additional safety, do not plug the printer and the instrument (or the optional power table) into the same wall outlet. Failure to observe this warning could result in electrical shock to the patient and/or examiner. WARNING: Do not open the instrument covers. Opening the instrument covers could expose you to electrical and optical hazards.

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WARNING: Unless connected to an isolation transformer, to maintain patient safety, peripheral devices that are not Medical Device approved (i.e., printer, USB drive, etc.) must be placed at least 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. In addition, the instrument operator must not touch the patient and a peripheral device at the same time while examining the patient. WARNING: Do not reconfigure system components on the table, nor add non-system devices or components to the table, nor replace original system components with substitutes not approved by Carl Zeiss Meditec. Such actions could result in failure of the table height adjustment mechanism, instability of the table, tipping and damage to the instrument, and injury to operator and patient. WARNING: This instrument may cause ignition of flammable gases or vapors. Do NOT use in the presence of flammable anesthetics such as nitrous oxide, or in the presence of pure oxygen. WARNING: Avoid tipping. Do not use the instrument on an uneven or sloped surface. Do not roll the table in deep pile carpet or over objects on the floor such as power cords. Failure to observe these precautions could result in tipping of the instrument and/or table and resulting injury to operator or patient and damage to the instrument.

Electromagnetic Compatibility (EMC) • EN 60601-1-2

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

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Note: Portable and mobile RF communications equipment can affect medical electrical equipment. WARNING: The use of accessories, transducers and cables other than those specified may result in increased emissions or decreased immunity of the equipment. WARNING: The HFA II-i should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used.

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