Zeiss Humphrey matrix User Manual

Zeiss Humphrey matrix User Manual

Visual field instrument

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Summary of Contents for Zeiss Humphrey matrix

  • Page 1 Visual Field Instrument with USER’S GUIDE . • 5160 H , USA 94568 • 877-486-7473 EISS EDITEC ACIENDA RIVE UBLIN ALIFORNIA • MAIL INFO MEDITEC ZEISS HTTP MEDITEC ZEISS . 701692 R PRINTED IN U...
  • Page 2 AUS. Pat. 611,585; 701,075 Others Pending Trademarks ® Humphrey is a registered trademark of Carl Zeiss Meditec Inc. in the United States and other countries. ® Welch Allyn is a registered trademark of Welch Allyn, Inc. in the United States and other countries.
  • Page 3: Table Of Contents

    The information in this User’s Guide is based on Humphrey Matrix SBC Software V04.04.XX. Table of Contents USER’S GUIDE ............. 1 IMPORTANT SAFETY INFORMATION - PLEASE READ FIRST .
  • Page 4 7 DATABASE MANAGEMENT ..........31 DATABASE BACKUP .
  • Page 5: User's Guide

    SERVICE or REPAIR to be performed by QUALIFIED, AUTHORIZED PERSONNEL ONLY. There are NO USER SERVICEABLE PARTS INSIDE the Humphrey Matrix instrument. Disassembly of the instrument presents a possible ELECTRICAL SHOCK hazard and will VOID the warranty. REPLACEMENT PARTS and ACCESSORIES- Use only approved replacement parts and accessories specified in this manual.
  • Page 6 Connection of any other computer port or device to the computer interface connector may damage the instrument. This computer interface is reserved for future use Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 7: Introduction

    1 INTRODUCTION Thank you for purchasing the Humphrey Matrix Visual Field Instrument, featuring Welch Allyn’s Frequency Doubling Technology. This revolutionary new instrument represents the latest breakthrough in visual field testing, providing early detection of glaucoma and management of visual field loss.
  • Page 8: Instrument Components

    USB printer cable are included with the instrument. Detachable Patient Response Button with holder, two Power Cords (one for the instrument and one for the printer), Calibration Cap and dust cover are also provided. Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 9: Frequency Doubling Technology (Fdt) Overview

    (M-cell) pathway. These M-cells have large diameter fibers and comprise only 3% to 5% of all retinal ganglion cells. The damage to these cells in the disease process is detected effectively and efficiently by FDT. Refer to the Clinical Examples Reference Guide for more information. Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 10: Instrument Set Up

    2 INSTRUMENT SET UP Because of its light weight and small size, you can set up your Humphrey Matrix virtually anywhere in your office. Please refer to the information provided in the printer box for printer set-up, use, maintenance and service information. Refer also to the Training video on CD for instrument set-up instructions.
  • Page 11: Preparation For Use

    PRINTER (USB) CONNECTION Plug the Universal Serial Bus (USB) printer cable supplied with the printer into the USB jack located underneath the base, adjacent to the keyboard and mouse connections. Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 12 (Figure B). PRINTER- Use only the printer and printer cables provided (or approved alternate) with this device to meet medical safety requirements. The Humphrey Matrix instrument must provide the printer power or there is a risk of comprised patient isolation.
  • Page 13: General Operation

    Operator LCD Display. Once the Power Switch on the Matrix is turned ON, press the Printer Power Button to turn the Printer ON. Note that the Printer will only operate when the Humphrey Matrix power is ON. TO TURN THE INSTRUMENT OFF First, press the Printer Power Button to turn the Printer OFF .
  • Page 14 F5 System Settings Screen. All Humphrey Matrix data stored on the hard disk, CD, and/or floppy discs are your records, and it is your responsibility to preserve the integrity of these data / files. Welch Allyn and Carl Zeiss Meditec are not responsible for the loss of patient data / files stored on the hard disk, CD and/or floppy disks.
  • Page 15 To delete a patient, it is necessary to delete all of his or her field tests in the Recall Tests (F3) Screen first. Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 16 Once the desired individual tests are selected, you can then recall, delete, print, or save to floppy or CD-R (as JPEG image, Humphrey Matrix database backup, or CSV text format) the test results. In addition, operator entered test information is available for editing. Note that deleting a test from the database is permanent.
  • Page 17 The File Functions Screen is where the patient test database is backed up or imported / merged / restored. The File Functions Screen is also where available software upgrades of the Humphrey Matrix system software are performed. Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 18 F5: SYSTEM SETTINGS The System Settings Screen provides the operator with the ability to customize the configuration of the Humphrey Matrix Visual Field Instrument by changing default system settings. Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 19 The Help Screen is where the user may view the instrument’s system information and the User’s Guide. When needed, the Calibration, Diagnostics, and Logging Functions are also accessed from the Help Screen. Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 20: Test Results And Reliability Measures

    The N-30-5 (or N-30-1) FDT screening test is essentially the same 19-point rapid screening test performed on the Humphrey FDT Visual Field Instrument, except that moving the fixation target is not required with the Humphrey Matrix. The same normative database is used for the N-30 Humphrey Matrix Visual Field Instrument...
  • Page 21: Threshold Tests

    Humphrey FDT and Humphrey Matrix Visual Field Instruments so the tests are comparable between the two instruments. Each test location is assigned one of four probability levels, depending on the test selected. Each visual field location is tested until the patient responds, or until all three probability levels are tested.
  • Page 22 The magnitude of the MD & PSD values are directly correlated to the Humphrey Field Analyzer indices. Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 23: Probability Level Classifications

    False negative errors indicate the patient is likely not paying attention, does not understand the test, or has a severe loss at the location of the false negative catch trial(s). Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 24: Patient Testing

    YYYY is the system default (i.e. 12 25 1919 for December 25, 1919). Once the required patient information is entered, select the Add Patient Button to open the Testing Screen (see Figure D). Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 25 Figure (C) Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 26: Administering The Test

    Folder, Test Speed, and Fixation Target. Refer to the System Settings section of this User’s Guide for more information. You can change each of these by using the pull down menu (click on the arrow to change if necessary). Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 27 The markings on the cross hair are in 1mm increments. Press the Unfreeze Button to return to live video. Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 28: Patient Correction

    Unless the tested eye accurately fixates on the target while responding to stimuli, there is a possibility of unreliable results. A comfortable patient position with good fixation is more important than obtaining or keeping exactly centered alignment. Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 29: Testing

    MAIN MENU (F1) or the FILE FUNCTIONS (F4) Screen. As most CD-R disks are limited to about 48 separate writes, you can back up almost a year’s worth of tests on a single CD-R media. Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 30: Explaining The Test Procedure To The Patient

    Please remember to keep looking at the black spot in the center of the screen at all times during the test. ” It is a good idea to encourage the patient throughout the testing to help ensure proper patient alignment, fixation, and attention. Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 31: Viewing And Printing Test Results

    Gray Scale Total Deviation Probability Plot Total Deviation (dB) Pattern Deviation Probability Plot Pattern Deviation (dB) Note: Only the Total deviation probability plot is available for screening tests. Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 32: Printing Test Results

    Save As... to save the test to a floppy or CD-R in any of three formats: • Database Backup format, which will save the test in Humphrey Matrix database format, which is only read by a Humphrey Matrix instrument;...
  • Page 33: Printer Control Panel

    It is normal for a delay of up to 30 seconds from when the printing is requested until the printing actually begins. For other questions regarding the operation of the printer, please refer to the Printer information supplied with the printer. Figure (H) Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 34: Analysis

    Destination. Count is the number of available tests for each of the Test Selections. A sample Overview Plot is included at the end of this User’s Guide for your reference. Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 35: Database Management

    CD-R media. It is also a good idea to alternate between two CD-R media with each backup in case a problem develops with one of the media. Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 36: Database Restore

    Upgrade System section of the File Functions Screen to upgrade the instrument software. Reference the software upgrade instructions provided with the upgrade for details. The Help (F6) Screen will identify which versions of the Humphrey Matrix software are installed. Humphrey Matrix Visual Field Instrument...
  • Page 37: Set-Up, Calibration And Maintenance

    Cancel. SYSTEM SETTINGS (F5) System Settings are provided to allow you to customize the operation of the Humphrey Matrix instrument to meet your preferences and practice needs (see Figure K). * indicates factory default system settings that probably meet most of your needs already. Select Reset Settings to return the instrument to the factory default system settings.
  • Page 38 Contact Information: Enter text information for printing on the visual field printouts in the lower right corner. Typical use is to enter information for the practice or doctor. Select Update to accept a change to the Contact Information. Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 39: Calibration

    CALIBRATION The Humphrey Matrix Visual Field Instrument does not require scheduled calibration. The instrument calibration is automatically checked each time the instrument is powered ON and at the start of each test to be sure the unit is properly calibrated. If the instrument detects the need for calibration, the Operator LCD Display will display a needs calibration warning.
  • Page 40: Cleaning, Disinfection, And Sterilization

    Damage to internal components may occur and are not covered by the instrument warranty. Sterilization Do not sterilize the instrument or any of its components Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 41: Warranty And Service Information

    9 WARRANTY AND SERVICE INFORMATION WARRANTY INFORMATION Carl Zeiss Meditec warrants the Humphrey Matrix Visual Field Instrument, when new, to be free from defects in materials and workmanship and to perform in accordance with the manufacturer’s specifications for a period of one year from the date of purchase from Carl Zeiss Meditec or its authorized distributors or agents.
  • Page 42: Replacement Parts And Accessories

    Power Cord - UK 76404 Power Cord - Australia 76406 Humphrey Matrix User’s Guide - English 701692* Humphrey Matrix Quick Reference Guide - English* 112753-1 Humphrey Matrix Training Video - CD (English) 112755 Humphrey Matrix Training Video - VHS (English) SM2519...
  • Page 43: Troubleshooting Guide

    Replace power cord if power up power cable connections. Ensure defective. that the power cord is inserted firmly in the Humphrey Matrix Connect instrument power power input receptacle. The cord to a working outlet. receptacle is located underneath the base of the instrument.
  • Page 44 Check the USB cable on a known Replace the printer USB working USB peripheral if cable if defective. available. Replace the printer if No paper in the printer. defective. Missing or empty ink cartridges. Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 45: Help (Including Diagnostics)

    Figure (M) The User’s Guide Button displays a PDF version of the Humphrey Matrix User’s Guide. The Quick Ref. Button displays a PDF version of the Humphrey Matrix Quick Reference Guide (also included at the end of this User’s Guide).
  • Page 46 Diagnostics The Diagnostics Screen (see Figure N) provides basic information regarding the operational status of the Humphrey Matrix instrument. This screen is useful if you are experiencing problems with your Humphrey Matrix Instrument. Problem areas are indicated by different color text.
  • Page 47 Show LCD Pattern test, Play Scale and MCU Beep sound tests CRT tests: View Pattern, Ambient Light test, Calibration Status check, Monitor Brightness check. Camera: Camera Display check Figure (O) Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 48 The internal computer provides a variety of logging functions during the operation of the Humphrey Matrix instrument that are reserved for Technical Service use in troubleshooting any problems. Export the logs individually or all at once to a floppy, CD-R, or printer. Printing these logs is generally not recommended due to formatting issues and extended printing time for large logs.
  • Page 49: Technical Specifications

    10 TECHNICAL SPECIFICATIONS This instrument is manufactured exclusively for CARL ZEISS MEDITEC by: Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, New York 13153-0220 USA INSTRUMENT SPECIFICATIONS Dimensions: 30 cm [12''] wide x 56 cm [22''] deep x 43 cm [17''] high...
  • Page 50: Visual Field Test Specifications

    Central 30 5 x 5 0.50 30-2 Threshold Central 30 5 x 5 0.50 10-2 Threshold Central 10 2 x 2 0.50 Macula Threshold Central 5 2 x 2 0.50 Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 51 (~40 dB is the maximum human visual field sensitivity) • Contrast range 24-2, 30-2, 10-2 & Macula tests: 38 dB (~ 0%) to 0 dB (~ 100%) • Optical system: Badal type Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 52 Horizontal axis offest +/- 1 degree Vertical axis offest +/- 3 degrees (~1 degree square stationary central fixation target) Right Eye HFAll 24-2 (54 pts) HFAll 30-2 (76 pts) N-30 (19 pts) Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 53 Horizontal axis offest +/- 1 degree Vertical axis offest +/- 3 degrees (~1 degree square stationary central fixation target) Right Eye HFall 24-2 (54 pts) HFAll 30-2 (76 pts) 24-2 (55 pts) 30-2 (69 pts) Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 54 +/- 1 degree axis offests outside central 4 degrees Right Eye (~1 degree square stationary central fixation target) HFall Macula (16 pts) HFAll 10-2 (68 pts) Macula (16 pts) 10-2 (44 pts) Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 55: Standards Compliance

    TYPE BF Indicates this equipment contains Type BF applied parts; the patient forehead rest and patient response button. TUV listed to comply with UL 2601-1:1997 CSA C22.2 No. 601.1-M90 IEC 60601-1:1990+A1+A2+A13 IEC 60601-1-2:2001 CB certified to Medical Electrical Equipment IEC60601-1 Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 56 Complies with: IEC 60065 IEC 60601-1-4 ANSI/ESNA RP27 .1:1996, RP27 .2:2000, RP27 .3:1996 IEC 60825-1:1994+A1+A2 IEC 60825-9 IEC 60950-1 Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
  • Page 57 Guidance and manufacturer’s declaration - electromagnetic emissions The Humphrey Matrix is intended for use in the electromagnetic environment specified below. The customer or the user of the Humphrey Matrix should assure that it is used in such an environment. Emissions Test...
  • Page 58 Guidance and manufacturer’s declaration - electromagnetic immunity The Humphrey Matrix is intended for use in the electromagnetic environment specified below. The customer or the user of the Humphrey Matrix should assure that is used in such an environment. IEC 60601 test...
  • Page 59 Guidance and manufacturer’s declaration - electromagnetic immunity The Humphrey Matrix is intended for use in the electromagnetic environment specified below. The customer or the user of the Humphrey Matrix should assure that is used in such an environment. IEC 60601 test...
  • Page 60 Recommended separation distances between portable and mobile RF communications equipment and the Humphrey Matrix The Humphrey Matrix is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Humphrey Matrix can help prevent...
  • Page 61: Software Licenses

    SOFTWARE LICENSES The software provided with the Humphrey Matrix visual field instrument consists of software written by Welch Allyn, Inc. (the Matrix Software), as well as software written by third parties (the Third-Party Software). Matrix Software is governed by this license and the other Third-Party...
  • Page 62 WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. 6. 6. Limitation of Liability. The cumulative liability of Welch Allyn or Carl Zeiss Meditec to you or any other party for any loss or damages resulting from any claims, demands, or actions arising out of or relating to this License Agreement shall not exceed the price you paid to Carl Zeiss Meditec for the Matrix instrument.
  • Page 63: Sample Tests

    Humphrey Matrix Visual Field Instrument Rev. D 08/21/06 PN 701692...
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  • Page 73: Quick Reference Guide

    ® Humphrey Matrix Quick Reference Guide Select Test Type From the Main Menu Screen (F1), select one of the Test Type Buttons or the Select Patient Button with the mouse pad or Hot Key (Alt+ underlined letter). Both selections proceed to the View Patients (F2) Screen. Select Existing Patient or Add New Patient From the View Patient Screen (F2), select an existing patient from the patient listing displayed on the screen by...
  • Page 74 When testing both eyes: If the system settings are set for Automatic Printing then the test results will automatically print once the tests for both eyes are complete or when either Done Testing or New Test is selected. Carl Zeiss Meditec, Inc. Dublin, CA 94568 877-486-7473 with www.meditec.zeiss.com...

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