Zeiss Humphrey FDT User manual

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UMPHREY

FDT Visual Field Instrumen t

PRINTED IN U.S.A. Part No. 112098-1 Rev. D

EISS HUMPHREY SYSTEMS

E-MAIL: INFO@HUMPHREY.COM

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SER’S GUIDE

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ALIFORNIA

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WWW.HUMPHREY.COM

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, USA 94568 • 877-486-7473

Patents

USA 5,065,767, Australia 611,585 Patents Pending in USA and other countries.

Trademarks

Humphrey is a registered trademark of Zeiss Humphrey Systems in the Unit ed States and other countries. Welch Allyn is a registered trademark of Welch Allyn, Inc. in the United States and other countries.

Every effort has been made to ensure that the information contained in this manual is true and correct at the time of printing. Any errors and omissions are unintentional and will be corrected in future revisions.

‹#

PLEASE READ

IMPORTANT SAFETY INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

INTRODUCTION

ABOUT THE USER’S GUIDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

INSTRUMENT OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

INSTRUMENT COMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

FDT OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

OPERATING PROCEDURES

UNPACKING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

PREPARATION FOR USE AND POWER ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

PREPARING FOR A PATIENT TEST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

RUNNING A SCREENING OR THRESHOLD PATIENT TEST . . . . . . . . . . . . . . . . . . . . . . . 14

DISPLAYING & PRINTING THE TEST RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

USING THE RS-232 SERIAL COMPUTER INTERFACE . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

UNDERSTANDING THE SCREENING TEST RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

UNDERSTANDING THE FULL THRESHOLD TEST RESULTS . . . . . . . . . . . . . . . . . . . . . . 19

SCREENING C-20 TEST RESULTS SAMPLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

THRESHOLD C-20 TEST RESULTS SAMPLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

THRESHOLD N-30 TEST RESULTS SAMPLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

CALIBRATION AND SET-UP, MAINTENANCE AND TROUBLESHOOTING

CALIBRATION AND SET-UP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Set Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Set-up Instrument Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Software Upgrade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Printer Paper Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Replacement Parts and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Product Model Numbers (710 SERIES) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Cleaning, Disinfection and Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

WARRANTY AND SERVICE INFORMATION

WARRANTY INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

SERVICE INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Technical Assistance Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

TECHNICAL SPECIFICATIONS

INSTRUMENT SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

ENVIRONMENTAL SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

TEST SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

STANDARDS COMPLIANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

FDT QUICK REFERENCE GUIDE

PLEASE READ

IMPORTANT SAFETY INFORMATION

All operating personnel should be familiarized with the general safety information in this summary. Additional safety information may also be found throughout this manual.

ATTENTION - refer to the operating instructions.

operating personnel to the presence of important operating or maintenance instructions in the documents accompanying the instrument.

OPERATING VOLTAGE SELECTION - select the desired operating voltage range, either 115V or 230V, before connecting the power cord to the applian ce inlet conn ec tion and be fore applying power to the instrument.

setting. Refer to the Preparation for Use and Power On section of this manual for instructions to change the Voltag e Selector position.

FUSE REPLACEMENT-

T .315A 250V.

Refer to the Preparation for Use and Power On section of this manual for instructions to inspect or change the fuses.

SERVICE or REPAIR to be performed by QUALIFIED, AUTHORIZED PERSONNEL ONLY.

There are beyond the extent required to change the PRINTER PAPER, FUSES, or PATIENT RESPONSE BUTTON as described in this manual presents a possible

the warranty.

VOID

REPLACEMENT PARTS and ACCESSORIES-

accessorie s specified in this manual. Refer to the maintenance section of this manual for more information.

For the

NO USER SERVICEABLE PARTS INSIDE

For the

Voltage Selector position, replace the fuses with TYPE

230V

Be sure the proper fuse values are used for each voltage

voltage selector position, replace the fuses with TYPE

115V

This symbol is intended to alert the

T .160A 250V

the instrume nt. Di sassem bly of th e instrument

ELECTRICAL SHOCK

Use only approved replacement parts and

hazard and will

MAINS DISCONNECT-

POWER CORD-

DO NOT STERILIZE the instrument or any of its components.

After unpacking the instrument

the finger cutouts on the sides of the door (near the top), and

BEFORE using the pr inter

in the door.

printer.

fields (such as MRI).

Failure to remove the shipping wedge will result in improper operation of the

DO NOT USE the instrument near other equipment which produces strong magnetic

Disconnect from the mains via the appliance inlet.

Use an approved hospital-grade power inlet cord only.

, pull down the

. Close the printer door. Be sure the paper is sticking out through the slot

The video monitor performance may be adversely affected.

printer door

(below the LCD display), using

remove the foam shipping wedge

HUMPHREY FDT VISUAL FIELD INSTRUMENT PLEASE READ/ 1 REV. D 01/00 PN 112098-1

PLEASE READ

LCD DISPLAY CONTRAST -

Use the UP and DOWN arrows adjacent to the contrast symbol bel ow

the LCD display to adjust the LCD contrast for optimum viewing, based on lighting conditions.

TYPE BF

- Indicates this is a Type B product with Type BF applied parts; the patient forehead rest

and patient response Button.

SHIPPING and STORAGE TEMPERATURE range

exposed to betwee n

-20° C (-4° F) and +49° C (+120° F)

- Limit the temperatures the instrument is to avoid possible damage to the

instrument. Refer to the environmental specifications section of the manual for more information.

Patient Response Button Connector

Softwa re Upgrade Connector

RE F 710 SE RIE S

115V/230V 50/60 Hz 315mA/160mA

UL 2601 IEC 601-1

CSA C22.2

NO. 601-1

74227

PAT. PEND.

MADE IN U.S.A.

Computer Interface Connector

PATIENT RESPONSE BUTTON CONNECTOR

- Connect ONLY the patient response button supplied with the instrument or an approved replacement to the patient response button connector on the bottom of the instrument. Connection of any other device to the patient response button connector may damage the instrument or create an unsafe condition and will void the warranty.

COMPUTER INTERFACE CONNECTOR

- Connect ONLY

RS-232 serial compatible

computer ports to the computer interface connector on the bottom of the instrument. Use the null-modem configuration computer interface cable supplied with the instrument or an approved replacement cable. Connection of any other computer port or device to the computer interface connector may damage the instrument. Refer to the computer interface instructions for additional information.

SOFTWARE UPGRADE CONNECTOR

- The blank label on the bottom of the unit adjacent to this symbol covers the SOFTWARE UPGRADE CONNECTOR. The blank label should only be removed during a software upgrade and should be replaced when the upgrade is complete. Refer to the software upgrade instructions to update the instrument software.

2 / PLEASE READ HUMPHREY FDT VISUAL FIELD INSTRUMENT

REV. D 01/00 PN 112098-1

INTRODUCTION

ABOUT THE USER’S GUIDE

The USER’S GUIDE is designed to help you understand the capabilities and operation of the Humphrey FDT Visual Field Instrument with Welc h Allyn ’s FREQUENCY DOUBLING TECHNOLOGY. To achieve satisfactory results, the operator should read this manual thoroughly before using the instrument. An FDT Quick Reference Guide is provided for the convenience of experienced operators.

INTRODUCTION

INSTRUMENT OVERVIEW

The FDT Vis ual Fi eld Ins tr um ent is an inno v ati v e, efficient, compact and affordable automated visual field testing instrument. Years of research and clinical trials of Welch Allyn’s patented FREQUENCY DOUBLING TECHNOLOGY have resulted in an instrument which provides rapid, clinically validated and user-friendly visual field testing.

Key features of the FDT Visual Field Instrument include:

• Supra-threshold screening tests in less than 1 minute per eye

• Full-threshold tests in approximately 4 minutes per eye

• Easy to use; no special training is needed/minimal operator instruction

• No corrective (trial) lens needed; patients can wear their own correction or none at all (must only be within 7D of patient’s refraction

• No eye patch needed for the opposite (untested) eye - it’s automatically occluded

• Not affected by ambient lighting - can be used in normal room lighting

• Not affected by pupil size (as small as 2 mm)

• Extensive age-normative reference database incorporated

• World-class clinical validation by leading researchers in the field

• Statist ically signific ant correlation to the Humphrey Field Analyzer

• Software upgrade capability for future enhancements

HUMPHREY FDT VISUAL FIELD INSTRUMENT INTRODUCTION/ 3 REV. D 01/00 PN 112098-1

PATIENT’S SIDE INSTRUMENT COMPONENTS

Forehead Rest

INTRODUCTION

Patient Eyepiece

Power Cord

Voltage Selector Indicator

Patient Visor

Power Switch

4489

Po wer Cord Inlet

Patient Response Button

OPERATOR’S SIDE INSTRUMENT COMPONENTS

Calibration Cap

Operator Control Panel

Operator Buttons (Blue)

Cancel/Backup Button (Green)

Paper Access Door Finger Tab

Paper Access Door

Paper Release Lever

Operator LCD

Operator LCD Display Contrast Adjustment Buttons

Printer Paper

Paper Access Door Finger Tab

Paper Printout Slot

4 / INTRODUCTION HUMPHREY FDT VISUAL FIELD INSTRUMENT

REV. D 01/00 PN 112098-1

INSTRUMENT COMPONENTS

The instrument has seven Buttons to control the operation of the instrument, located adjacent to the Operator’s Liquid Crystal Display (LCD).

• Four BLUE Operator Buttons along the left side of the Operator LCD Display

• A GREEN Cancel/Backup Button below the four BLUE Buttons

• Two Operator LCD Display Contrast Adjustment Buttons (Down Arrow and Up Arrow) adjacent to the Contrast Symbol and directly below the LCD Operator Display

Further below the Operator LCD Display is a Paper Access Door which opens to provide access to the internal thermal printer for replacement of paper, when needed. The instrument has a sliding Patient Visor which aids in the selection of the eye to be tested and automatically occludes the opposite (untested) eye. Detachable Patient Response Button, Power Cord, and Calibration Cap are also provided.

FDT OVERVIEW

isolates a subset of retinal ganglion cell mechanisms in the magnocellular (M-cell) pathway.

FDT

These M-cells have large diameter fibers and comprise only 3% to 5% of all retinal ganglion cells. The damage of these cells in the disease process makes FDT efficient and effective for the detection of visual field loss.

INTRODUCTION

HUMPHREY FDT VISUAL FIELD INSTRUMENT INTRODUCTION/ 5 REV. D 01/00 PN 112098-1

PATIENT’S VIDEO SCREEN PATTERNS

INTRODUCTION

6 / INTRODUCTION HUMPHREY FDT VISUAL FIELD INSTRUMENT

REV. D 01/00 PN 112098-1

OPERATING PROCEDURES

UNPACKING

This instrument is designed for use by anyone familiar with the operation as described in this manual; no special qualif ications are required. Anyone using this instrument shou ld read and understand the operating instructions manual before using t he instrument. Interpretation of the results should be performed only by appropriately trained eyecare professionals.

Open the shipping box by carefully cutting the pac king tape securing the top flaps of the box. Lift out the foam insert containing the Patient Response Button, Power Cord and extra roll of paper. Lift the instrument ou t of the remaini ng f oam ins ert b y graspi ng the ins tr umen t at the two cu touts pro v ided and set the instrument on a flat, stable surface. Remove the plastic bag from the FDT Visual Field Instrument. Use of an adjustable height chair and/or table is recommended when performing testing.

After you have unpacked the instrument and its components, confirm that you have received the following items in good condition:

• Humphrey FDT Visual Field Instrument

• Calibration Cap (covering the Patient’s Eyepiece inside the Patient Visor)

• Patient Response Button

• Power Cord (appropriate for local operating voltage)

• Extra roll of paper

RETAIN THE SHIPPING MATERIALS (BOX AND PACKAGING) IN THE EVENT OF SHIPPING DAMAGE OR FOR RETURN, IF NECESSARY, TO AN AUTHORIZED SERVICE OR DISTRIBUTION LOCATION AT ANY TIME IN THE FUTURE.

After unpacking the instrument,

using the Finger Tabs on the sides of the door.

the printer.

door.

Close the Paper Access door while guiding Printer Paper through the Paper Slot in the

Failure to remove the shipping wedge will result in improper operation of the printer.

pull down the

Paper Access Door

Remove the foam shipping wedge

(below the LCD display)

before

using

OPERATING PROCEDURES

Paper Access Door Paper Access Door Finger Tab

Finger Tab

HUMPHREY FDT VISUAL FIELD INSTRUMENT OPERATING PROCEDURES / 7 REV. D 01/00 PN 112098-1

PREPARATION FOR USE AND POWER ON

Patient Side

Tip

Operator Side

RE F 710 SE RIE S

115V/230V 50/60 Hz 315mA/160mA

UL 2601 IEC 601-1

CSA C22.2

NO. 601-1

74227

PAT. PEND .

MADE I N U. S.A.

OPERATING PROCEDURES

While facing the Patient Side of the FDT instrument, tilt the instrument to plug the

Response Butt on

connector into the small roun d connecto r jack. The jack is loca ted underne ath the

Patient

base of the unit (at the center) and near the patient response button symbol .

connecting the Power Cord and

Before

Voltage Selector Indicator

adjacent to the

applying power to the instrument, be sure the

before

O/I Power Switc h

displays the app r op ria te opera t in g

voltage (115V or 230V).

115V

Voltage Selector Indicator

To chang e the F us e Carrier/Voltage Selector to the proper operating voltage

be sure the Power

Cord is NOT connected and use a flat screwdriver to pry open the Fuse Drawer Cover. Remove the

8 / OPERATING PROCEDURES HUMPHREY FDT VISUAL FIELD INSTRUMENT

REV. D 01/00 PN 112098-1

Fuse Carrier/Volta ge Selector, by again using a flat screwdriver, noting the placement of the fuses before removing them. Remove and replace them with the value indicated on the fu se rep la cemen t la be l (for 115V use TY PE and for

230V

fuse TYPE

T .160A 250V

fuse). Rotate the Fuse Carrier/Voltage Selec tor so the prop er

uses, by carefully prying them out and replacing

both

T .315A 250V

fuse

voltage will be visible when the Voltage Selection Door is closed. Re-install the Fuse Carrier. Close the Fuse Drawer Cover and check to be sure the proper voltage appears in the Voltage Selection Window. Refer to the Replacement Parts and Accessories section of this manual for fuse part numbers and ordering information.

Power Switch

4 4

563

OPERATING PROCEDURES

Fuse Carrier/Voltage Selector

5639

4489

Selected Voltage

Fuse Drawer Cover

HUMPHREY FDT VISUAL FIELD INSTRUMENT OPERATING PROCEDURES/ 9 REV. D 01/00 PN 112098-1

Plug the appropriate approved hospital grade detachable Power Cord into the Power Cord Inlet on the operator’s right-hand side and plug the opposite end into a standard power outlet.

448 9

OPERATING PROCEDURES

Power Switch

To turn the instrument ON

the ON

(I) position

. The instrument will perform internal self-diagnostic checks and after

, switch the

Power Switch (O/I)

approximately 15 seconds, two double beeps will sound and the the Operator LCD Display. Refer to the troubleshooting section of this manual if the

does not appear.

: You may need to adjust the

Note

LCD contrast

Power Cord Inlet

, adjacent to the power connector, to

FDT MAIN MENU

will appear on

FDT MAIN

in order to read the Operator LC D Displ ay; use the triangle shaped buttons below the Operator LCD Display to increase (up-arrow) or decrease (downarrow) the LCD contrast.

FREQUENCY DOUBLING TECHNOLOGY MAIN MENU RUN PATIENT TEST

RUN DEMONSTRATION

ADVANCE PAPER

Return to Main Menu Decrease Contrast

: the

Note

the

GREEN Button

FDT MAIN MENU

UTILITIES MENU

may be used at any tim e to back-up to the previous menu and to return to

(it may need to be pressed several times to reach the

24 JUN 1997 04:08 PM

Increase Contrast

FDT MAIN MENU

10 / OPERATING PROCEDURES HUMPHREY FDT VISUAL FIELD INSTRUMENT

REV. D 01/00 PN 112098-1

+ 32 hidden pages

Zeiss Humphrey FDT User manual

TABLE OF CONTENTS

PLEASE READ

IMPORTANT SAFETY INFORMATION

INTRODUCTION

ABOUT THE USER’S GUIDE

INSTRUMENT OVERVIEW

INSTRUMENT COMPONENTS

FDT OVERVIEW

OPERATING PROCEDURES

UNPACKING