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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, 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

PREPARING FOR A PATIENT TEST

Remove the CALIBRATION CAP

Patient Ey epi ece w hen the instrument is not in use to minimize the a ccumul ation o f dust a nd de bris in the Patient Eyepiece.

from the Patient Eyepiece. Replace the calibration cap on the

Select RUN PATIENT TESTS FULL THRESHOLD C-20 TEST

FREQUENCY DOUBLING TECHNOLOGY MAIN MENU RUN PATIENT TESTS

RUN DEMONSTRATION

ADVANCE PAPER

UTILITIES MENU

from the

or a

FDT MAIN MENU

FULL THRESHOLD N-30 TEST.

24 JUN 1997 04:08 PM

to prepare for a

SCREENING C-20 TEST,

OPERATING PROCEDURES

Note

: Once

RUN PA TIENT TES TS

is selected, typical FDT stimu lus presen tations are automa tically

displayed to demonstrate the test to the patient until the test actually starts.

HUMPHREY FDT VISUAL FIELD INSTRUMENT OPERATING PROCEDURES/ 11 REV. D 01/00 PN 112098-1

Enter the Patient’s Age

The unit will start with an

by 10 year increments (e.g. to 60, 70, and so on). Select

AGE the top) top)

and so on). Select

to decrease the

to increase the

ACCEPT SETTING (BOTTOM BLUE Butto n)

AGE

+10 YEARS AGE: 50

- 10 YEARS

+1 YEAR

of 50 years. Select

AGE

by 1 0 year increments. Select

AGE

in 1 year increments to adjust to the exact age of the patient (e.g. 51, 52,

ENTER PATIENT AGE

+10 YEARS (TOP BLUE Button)

-10 YEARS (2nd BLUE Button from

+ 1 YEAR (3rd BLUE But t on fr om the

when the correct

to increase the

is display e d.

AGE

OPERATING PROCEDURES

Slide the

Patient Visor

ACCEPT SETTING

to the

right eye test position

24 JUN 1997 04:08 PM

(this is to your right when looking at the

patient from the operator’s side).

: If you want to

Note

the

left eye test position

and select

SKIP RIGHT EYE

skip

the

right eye

(i.e., only test the left eye), then

slide

the

Patient Visor

now (this is to your left when facing the patient from the operator’s side)

Prepare the Patient

Place the

Patient Response Button

patient to place their forehead on the

video screen

. Adjust the

height

the patient. Confirm that the pa tien t ca n se e the enti re li t vid eo s creen , inc lu din g al l four corners, in the Patient Eyepiece and the black dot in the middle of the screen.

: Be sure the patient is positioned comfortably (not hunched over) by adjusting the height of

Note

the chair or table (or both).

in the patient’s hand and show them how to press it. As k the

Forehead Rest

and look into the

Patient Eyepiece at the

of the chair or table (or both) to obtain a comfortable position for

Patient Refraction

The their refraction). If a patient is wearing glasses, confirm that their glasses frame does not obscure any of the lit po rtion of the di spla y. Ask the patient to remo ve their glasses for the test if their l enses or contact lenses are tinted or change c ontra s t based on lighting conditions (photochromatic). Tests may be taken with bifocal or progressive lenses (unless the progressive lenses have more than 3D equivalent sphere distance correction).

12 / OPERATING PROCEDURES HUMPHREY FDT VISUAL FIELD INSTRUMENT

test may be taken with or without the patient’s correction (if the patient is within 7D of

FDT

REV. D 01/00 PN 112098-1

Explain the Test Procedure to the Patient

“A demonstration of the test is running now. Can you see the black dot in the center and the entire lit video screen? You need to stare at the black dot in the center of the screen during the entire test.”

“From time to time, you will see patterns of briefly appear in different areas of the screen. The patterns will other times be you see the

butto n once

by pressing the Button to respond to the patterns.” “It is OK to blink and a good time to blink is when you press the response Button. If you need to

rest or ask questions during the test, you can pause the test at any time by pressing and holding down the response Button. Do you have any questions? Do you understand how to take the test?”

“I will now start the test. There will be a few brief flashes and then the test will begin. Press the response Button once each time you see the pat terns, e v en if the bars are v ery faint. Ple ase remember to

the screen

very distinct

flickering black and white vertical bars

. Can you see thes e patterns in the demonstration r unnin g no w? You may practice now

during the entire test.”

. You are not expected to see the bar patterns at all times. Each time

flickering black and white vertical bars

sometimes

of one of the patterns,

flicke r ing blac k and whit e ver tical bars

stare at the bl ack dot in the cent er of

press the response

that will

very faint

of one of the

and at

OPERATING PROCEDURES

HUMPHREY FDT VISUAL FIELD INSTRUMENT OPERATING PROCEDURES/ 13 REV. D 01/00 PN 112098-1

: A separate

Note

DEMONSTRATION

the patient’s understanding of the test, if needed. To run a practice test, select

DEMONSTRATION (2nd BLUE Button from the top)

test is available from the

from the

FDT MAIN MENU

RUN

FDT MAIN MENU

to help facilitate

. A demonstration of the test stimulus automatically begins. The patient should use this time to become familiar with the test and practice using the

PA TIEN T RESPON SE BUTTON

(Ask the patient to look into the Patient Eyepiece within the P atien t V isor and th en t est the p rocedu re.) P res s the GREEN Button to cancel the practice test and return to the

FREQUENCY DOUBLING TECHNOLOGY MAIN MENU

RUN PATIENT TESTS

RUN DEMONSTRA TION

ADVANCE PAPER

FDT MAIN MENU.

OPERATING PROCEDURES

UTILITIES MENU

Be sure to prepare the patient as described above before running a practice test

24 JUN 1997 04:08 PM

RUNNING A SCREENING OR THRESHOLD PATIENT TEST

Select either RUN SCREENING TEST C-20, RUN FULL THRESHOLD C-20 TEST or RUN FULL THRESHOLD N-30 TEST

immediately

after a momentary check for proper calibration.

RUN SCREENING C-20 TEST

RUN FULL THRESHOLD C-20 TEST

RUN FULL THRESHOLD N-30 TEST

SKIP RIGHT EYE

GRN BUTTON CANCELS 24 JUN 1997 03:55 PM

from the

RIGHT EYE TEST MENU

RIGHT EYE TEST M ENU

. The right eye test will begin

: To

Note (BOTTOM Operator Button from the top)

: The Operator LCD Display will indicate if there is too much ambient light to perform a reliable

Note

skip

the

right eye

test and proceed directly to the left eye test, select

before

selecting a

SCREENING

SKIP RIGHT EYE

THRESHOLD

test.

test. Lower the room lighting or change the test location until suitable test conditions are achieved.

14 / OPERATING PROCEDURES HUMPHREY FDT VISUAL FIELD INSTRUMENT

REV. D 01/00 PN 112098-1

Also, if the Patient Response Button is not connected or the Patient Visor is in the wrong eye position, this will be indicated on the Operator LCD Display.

FULL THRESHOLD C-20 TEST (RIGHT EYE)

PERCENT COMPLET E:

2% PATIENT RESPONSE : N FIXATION ERRS : 0/0 FALSE POS ERRS : 0/0 FALSE NEG ERRS : 0/0

GRN BUTTON PAUSES 24 JUN 1997 04:05 PM

OPERATING PROCEDURES

The

PERCENT COMPLETE

ERRORS, FALSE POS ERRORS

scale, field location being tested,

and

FALSE NEG ERRORS

are displayed on the Operator LCD

PATIENT RESPONSE, FIXATION

Display during the test. Remind the patient to keep looking at the dot in the middle of the screen and inform them of the approximate percent complete at 3 or 4 times during the test to encourage good patient complia nce. Mo nitor the catch trials

NEG ERRS)

during the test. The catch trial display fields will be highlighted on the Operator LCD

(FIXATION ERRS, FALSE POS ERRS, and F A LSE

Display if 2 or more catch trials have been responded to by the patient. A high ratio on any of the catch trials indicates unreliable results and that the test should be restarted or repeated.

: You can

Note

test. F oll o w t he Ope rator LCD Di sp la y in structions to a down the the

. The patient can also PAUSE the test (for a break, etc.) by simply pressing and holding

pause

Patient Response Button

Patient Response Button.

(GREEN Button)

Note: A SCREENING C-20 TEST THRESHOLD C-20 TEST THRESHOLD N-30 TEST

PAUSE

RE-START

the test by pressi ng th e

GREEN Butt on

CONTINUE TEST

. The test will resume automatically once the patient releases

During patient pause, you may also select

so that the test will remain paused until you restart it.

takes less than

takes approx imately

1 minute

4 minutes

(per eye) to complete, a

(per eye) to complete and a

takes about 4-1/2 minutes .

at any time during the

or to

RE-START TEST

OPERATOR PAUSE

FULL

from

HUMPHREY FDT VISUAL FIELD INSTRUMENT OPERATING PROCEDURES/ 15 REV. D 01/00 PN 112098-1

At the end of the right eye test, the Operator LCD Display will prompt for a left eye test. Slide the

Patient Visor

to the

operator’s side).

left eye test position

Prepare the patient

(this is to your left when facing the patient from the

. Select

RUN SCREENING C-20 TEST (TOP Operator Button), RUN FULL THRESHOLD C-20 TES T (2nd Oper a to r Button from the top), or R UN FULL THRESHOLD N-30 TEST (3r d Oper at or Bu t t on fr om the t op)

begin the left eye test

immediately

RUN FULL THRESHOLD C-20 TEST

SKIP LEFT EYE

GRN BUTTON CANCELS 24 JUN 1997 04:10 PM

after a momentary check for proper calibration.

LEFT EYE TEST MENU

from the

LEFT EYE TEST ME NU

OPERATING PROCEDURES

Note

: To

skip

the

the results menu.

left eye

test, select

SKIP LEFT EYE (BOTTOM Operator Button)

to proceed to

16 / OPERATING PROCEDURES HUMPHREY FDT VISUAL FIELD INSTRUMENT

REV. D 01/00 PN 112098-1

DISPLAYING & PRINTING THE TEST RESULTS

You can both view th e res ul ts on the Ope rat or LCD Dis pl ay and print them out from the tes t res ul ts menu. At the end of a test, the results will be automatically printed (default set-up is automatic printing) and then the test results menu will automatically appear on the Operator LCD Display.

Select either

RESULTS (BOTTOM Operator Button)

on the Operator LCD Display. Use the you to toggle between the eye results or to return to the necessary). Select

VIEW RIGHT EYE RESULTS (3rd Operator But t on fr om the t op) or VIEW LEFT EYE

to view the indiv id ual eye results for the patient just tested

GREEN Button

to back-up to the previous screen to allow

FDT MAIN MENU

PRINT REPORT (TOP Operator Button)

to obtain additional copies of the

results for the patient just tested (you can print as many copies as you’d like).

FULL THRESHOLD C-20

PRINT REPORT TEST DATE/TIME: 24 JUN 1997 04:05 pm PATIENT AGE: 50 ADVANCE PAPER RIGHT EYE: TEST DURATION: 03:40 VIEW RIGHT EYE LEFT EYE: RESULTS TEST DURATION: 04:17

VIEW LEFT EYE RESULTS 24 JUN 1997 04:20 pm

(press it twice if

OPERATING PROCEDURES

: Once the test is completed, you can also select

Note Button from the top)

from the

FDT MAIN MENU

LAST PATIENT RESULTS (3rd Operator

to display or print out the results of the patient

just tested. The results of the most recently tested patient will remain in memory

begin a new test or until the instrument power is turned off.

only until you

HUMPHREY FDT VISUAL FIELD INSTRUMENT OPERATING PROCEDURES/ 17 REV. D 01/00 PN 112098-1

USING THE RS-232 SERIAL COMPUTER INTERFACE

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.

The instrument includes an external serial RS-232 serial computer interface connector located on the bottom of the instrument. This interface provides the user with the ability to upload results from the instrumen t to a compute r when the ac cessory computer in terf ace c able and software are used. For detailed information on using the computer interface, reference the FDT PC operating instructions, available from authorized representatives.

OPERATING PROCEDURES

UNDERSTANDING THE SCREENING C-20 TEST RESULTS

A plot of the 17 visual field locations tested will be pr inte d (see sample s on the following pages) and displayed on the Operator LCD Display for the supra-threshold eye test ed . Each test location will be either

of shading

“WITHIN NORMAL LIMITS”

- The patient

opportunity) when tested at the contrast level that

clear white

responded positively

99% (P > = 1%)

SCREENING C-20 TEST

or will hav e

one of three possib le levels

(on either the first or second

of normal subjects of the same

age would respond to for the test location with this shading.

“MILD RELATIVE LOSS”

normative contrast level

- The patient

(P = 1%)

after being

failed to respond positively

given 2 opportunities

when tested at the 1% age

to do so (the instrument will re-test any point mis s ed a t the 1% age normative level a second time ) for the test location with this shading.

“MODERATE RELATIVE LOSS”

opportunities

the

0.5%

“SEVERE L OSS”

to do so; t wice at the 1% age normative contrast level

age normative contrast level

- The patient

(P = 0.5%)

failed to respond positively

for the test location with this shading.

failed to respond positively

after b ein g

after being

(P = 1%)

and a third time at

given 4 opportunities

do so for the test locations with this shading; the 3 opportunities listed above and a fourth at the

maximum

contrast level of the instrument.

for each

given 3

18 / OPERATING PROCEDURES HUMPHREY FDT VISUAL FIELD INSTRUMENT

REV. D 01/00 PN 112098-1

When reviewing the results of the visual field test, careful consideration must be given to the

reliability ind ica tors

report and Operator LCD Display for the screening test. They are an important measure of patient reliability in taking the test (and of the reliability of the results). They are indicated as a ratio of the number responded to the number prese nted. For example, to 1 of the 3 catch trials presented.

(catch tria ls). The follo win g tw o test reliability indicators appear on the printe d

indicates that the patient resp onded

1/3

FIXATION ERRS : 0/3 FALSE POS ERRS : 0/3

FIXATION ERRORS

the blind spot versus the total number of times fixation was tested (i.e., total number of targets placed in the blind spot). Three Fixation errors indicate the patient is not maintaining good fixation during the test, is misaligned, or does not understand the test.

FALSE POSITIVE ERRORS

in the testing sequence (i.e., no target presented) versus the total number of “pauses” in the testing sequence. Three False positive errors indicate the patient is pressing the Button even if the patient doesn’t see any patterns or does not understand the test.

- The ratio of the number of times the patient responded to a target placed in

FIXATION catch trials

- The ratio of the number of times the patient responded to a “pause”

FALSE POSITIVE catch trials

will be randomly presented f o r each eye.

will be randomly presented for each eye.

UNDERSTANDING THE FULL THRESHOLD C-20 AND N-30 TEST RESULTS

A plot of the 17 or 19 visual field locations tested will be printed (see samples on the following pages) and a combination pl ot will be displayed on the Operator LCD Display for the

THRESHOLD C-20 and N-30 TEST

numerical contrast th reshold l e v el in units o f dB for each location tested. The second printed results plot is a deviation plot and will be either

shading

combination plot displayed on the Operator LCD Display will indicate both th e numerical cont rast threshold level and the shading for each location tested.

The patient achieved a threshold level in the range that same age achieved for the test locations with this shading.

The probability is less than threshold level that this patient achieved for the test locations with this shading.

corresponding age normative significance levels for each locati on tested. The results

5% (P < 5%)

2% (P < 2%)

for each eye tested. The first printed results plot will contain a

clear white

that a normal subject of the same age would perform at the

or will have

95% (P > = 5%)

one of

four

of normal subjects of the

FULL

possible levels of

OPERATING PROCEDURES

The probability is less than threshold level that this patient achieved for the test locations with this shading.

The probability is less than the threshold level that this patient achieved for the test locations with this shading. This shading will also occur if the patient

will be indicated).

1% (P < 1%)

0.5% (P < 0.5%) failed t o r e spond

that a normal subject of the same age would perform at the

that a normal subject of the same age would perform at

at the

maximum contrast level

of the instrument (

HUMPHREY FDT VISUAL FIELD INSTRUMENT OPERATING PROCEDURES/ 19 REV. D 01/00 PN 112098-1

When reviewing the results of the visual field test, careful consideration must be given to the

reliability indicators

(catch trials). The following three indicators appear on the printed report and on the LCD Display fo r the threshold test. They are an important measure of patient reliability in taking the test (and of the reliability of the results). They are indicated as a ratio of the number responded to the number presented. For example,

indicates that the patient responded to 1 of

1/3

the 3 catch trials presented.

FIXATION ERRS : 0/0 FALSE POS ERRS : 0/0 FALSE NEG ERRS : 0/0

OPERATING PROCEDURES

FIXATION ERRORS

- The ratio of the number of times the patient responded to a target placed in the blind spot versus the total number of times fixation was tested (i.e., total number of targets placed in the blind spot). Six

FIXATION catch trials

will be randomly presented for each eye in the C-20 TEST and N-3 0 TES T. Fixation errors indicate the p atient i s not main taining good fix ation d uring the test, is misaligned, or does not understand the test.

FALSE POSITIVE ERRORS

- The ratio of the number of times the patient responded to a “pause” in the testing sequence (i.e., with no target presented) versus the total number of “pauses” in the testing sequence. Six

FALSE POSITIVE catch trials

will be randomly pres ente d for eac h eye in the C-20 TEST, eight in the N-30 TEST. False positive errors indicate the patient is pressing the Button even if patient does not see any patterns or the patient does not understand the test.

FALSE NEGATIVE ERRORS

- The rati o o f the nu mb er o f ti mes th e p ati ent did n ot re sp ond to a test pattern at the maximum possible contrast level of the instrument versus the total number of times that maximum possible contrast level patterns were tested. Three

FALSE NEGATIVE catch trials

will be randomly presented for each eye in the C-20 TEST, five in the N-30 TEST. False negative errors indicate the pa tie nt is li kely to not be paying a ttention, does not understand the test, or has a severe loss at the location of the FALSE NEGATIVE catch trial(s).

For the threshold tests, the device utilizes a staircase threshold strategy known as a

Binary Search (MOBS)

threshold scores) is between

Minimum Contrast

(2048/c)*10*H where c ranges from 1 (minimum contrast) to 2048 (maximum contrast) and H

log

is approximately 2. Note that inconsistent patient responses which do not meet the

. The range of possible threshold level values for the

0 dB Maximum Contrast

(lowest patient sensitivity) and

highest patient sensitivity). The formula used to calculate the dB values is

will be displa yed, if the threshold c annot be determined due to

XX dB

threshold criteria. The magnitude of

MOBS

Modified

raw data

(patient

56 dB

the threshold level values is directly correlated to the Humphrey Field Analyzer values. The device also provides

MD & PSD

global statistical indices calculated from points over the entire visual field for the threshold test. These indices reduce the individual threshold scores to a single number to provide o v eral l information about the entire visual field. T he magnitude of the values are directly correlated to the Humphrey Field Analyzer

MD & PSD

indices. The actual

MD & PSD

formulas used for the MD & PSD indices calculations can be found in the references (2, 3).

20 / OPERATING PROCEDURES HUMPHREY FDT VISUAL FIELD INSTRUMENT

REV. D 01/00 PN 112098-1

“The MD (Mean Deviation)

index signifies overall severity of field loss. It is affected both by the degree of loss and the number of affected locations. A positive number indicates that the average sensitivity is above the average normal for age, whereas a negative number indicates that the

average sensitivity is below the average normal value.”

When the MD value is

LESS

than that of

of normal FDT fields, the percentile probability is

95%

given (P < 5%, P < 2%, P < 1%, or P < 0.5%) on the Operator LCD Display and on the printed report.

“The

PSD (Pattern Standard Deviation)

index is the standard deviation of the difference of each sensitivity value from an expected value (based on the normal value at that location and the mean deviation index), each difference weighted according to the variance of the normal values at that point. The becomes large as some points are more affected than others, and thus the

localized change in the field.” When the

is small in a no rmal fi eld, or in a fiel d wher e all points are eq ually abno rmal. T he

PSD

is an index of

PSD

value is

GREATER

than that of

of normal FDT fields, the percentile probability

95%

PSD

is given (P < 5%, P < 2%, P < 1%, or P < 0.5%) on the Operator LCD Display and on the printed report.

OPERATING PROCEDURES

1 Tyrrell RA, Owens DA: A New Technique to Rapidly Assess the Resting States of the Eyes and Other

Threshold Phenomena: the Modified Binary Search (MOBS) Whitely Psychology Laboratories ,

Pennsylvania State University. 2 Anderson, DR: Automated Static Perimetry Mosby Year Book, St. Louis, 1992; p. 84. 3 Anderson, DR: Automated Static Perimetry Mosby Year Book, St. Louis, 1992; p. 86.

HUMPHREY FDT VISUAL FIELD INSTRUMENT OPERATING PROCEDURES/ 21 REV. D 01/00 PN 112098-1

SCREENING C-20 TEST RESULTS SAMPLE

SCREENING C-20 NAME _________________

AGE 67 ID ___________ 30 JUN 1997 03:02 pm

RIGHT EYE

Test duration : 00:43 min

Deviation

FIXATION ERRS 0/3 FALSE POS ERRS 0/3

LEFT EYE

Test duration : 00:40 min

OPERATING PROCEDURES

Deviation

FIXATION ERRS 0/3 FALSE POS ERRS 0/3

WITHIN NORMAL LIMITS MILD RELATIVE LOSS MODERATE RELATIVE LOSS SEVERE LOSS

22 / OPERATING PROCEDURES HUMPHREY FDT VISUAL FIELD INSTRUMENT

REV. D 01/00 PN 112098-1

THRESHOLD C-20 TEST RESULTS SAMPLE

FULL THRESHOLD C-20 NAME _________ ___ _____

AGE 55 ID ___________ 01 JUL 1997 12:1 3 a m

RIGHT EYE

Test duration : 03:28 min

Threshold (dB)

3531

Deviation

LEFT EYE

Test duration : 04:13 min

Threshold (dB)

Deviation

MD +0.88 dB PSD +2.97 dB

OPERATING PROCEDURES

MD +2.54 dB PSD +2.75 dB

FIXATION ERRS 0/6 FALSE POS ERRS 0/6 FALSE NEG ERRS 0/3

Probability Symbols

P >= 5% P < 5% P < 2%

P < 1% P < 0.5%

HUMPHREY FDT VISUAL FIELD INSTRUMENT OPERATING PROCEDURES/ 23 REV. D 01/00 PN 112098-1

THRESHOLD N-30 TEST RESULTS SAMPLE

OPERATING PROCEDURES

FULL THRESHOLD N-30 NAME _________ ___ _____

AGE 79 ID ___________ 30 JUN 1997 06:45 am

RIGHT EYE

Test duration : 04:07 min

Threshold (dB)

4045

Deviation

LEFT EYE

Test duration : 04:40 min

Threshold (dB)

Deviation

MD +4.07 dB PSD +4.01 dB

40 32

34 34

MD +6.10 dB PSD +4.36 dB

FIXATION ERRS 0/6 FALSE POS ERRS 0/8 FALSE NEG ERRS 0/5

Probability Symbols

P >= 5% P < 5% P < 2%

P < 1% P < 0.5%

24 / OPERATING PROCEDURES HUMPHREY FDT VISUAL FIELD INSTRUMENT

REV. D 01/00 PN 112098-1

CALIBRATION AND SET-UP,

FREQUENCY DOUBLING TECHNOLOGY MAIN MENU RUN PATIENT TESTS

RUN DEMONSTRATION

ADVANCE PAPER

UTILITIES MENU

MAINTENANCE AND TROUBLESHOOTING

24 JUN 1997 04:00 pm

CALIBRATION AND SET-UP

The

UTILITIES MENU

unless calibration or a change of the instrument set-up defaults is needed (set-ups are set to defaults and date and time (EST) have been pre-set).

on the

FDT MAIN MENU

should not be needed

Set Date and Time

To set the date and time, select

Button) MENU (TOP Operator Button) CLOCK MENU (TOP Operator Button) MENU

from the

FDT MAIN MENU

SET-UP INSTRUMENT MENU

RUN SELF-CALIBRATION

INSTRUMENT TESTS MENU

UTILITIES MENU (BOTTOM Operator

then select

in the

UTILITIES MENU

in the

UTILITIES MENU

SET-UP INSTRUMENT

and select

SET-UP INSTRUMENT

SET

ABOUT FREQUENCY DOUBLING TECHNOLOGY

24 JUN 1997 04:01 pm

SET-UP INSTRUMENT MENU

SET CLOCK MENU

SET-UP OPTIONS MENU

PRINT SET-UP REPORT

24 JUN 1997 04:01 pm

TROUBLESHOOTING

CALIBRATION AND SET-UP,

MAINTENANCE AND

HUMPHREY FDT VISUAL FIELD INSTRUMENT SET UP & MAINTENANCE / 25 REV. D 01/00 PN 112098-1

Set-up Instrument Options

Select

NEXT CHOICE (3rd Operator Button from the top)

clock setting you want to change. (V) and (W) setting. Select

correct CLOCK

return to the

DECREASE (2nd Operator Button from the top)

ACCEPT SETTINGS (BOTTOM Operator Button)

settings are displayed. Press the

FDT MAIN MENU

INCREASE YEAR: 1997

MONTH: JUN

DECREASE DAY: 24

HOUR: 4 pm NEXT CHOICE MINUTE: 2

12 HOUR FORMAT ACCEPT SETTINGS

INCREASE (TOP Operator Button)

SET CLOCK MENU

to select the

to change the

GREEN Button

24 JUN 1997 04:02 pm

when the

twice to

CALIBRATION AND SET-UP,

MAINTENANCE AND

TROUBLESHOOTING

SELECT LANGUAGE (2nd Operator Button from the top) Operator But ton)

from the

OPTIONS

, select

. Select

SET-UP OPTIONS MENU

SELECT LANGUAGE (top

SET-UP OPTIONS MENU

to c hoo se th e d es ired

language for the Operator LCD Display and results printout. Use

CHOICE (3rd Opera tor But t on from the top)

to select the desired language

from the list. Select

ACCEPT SETTINGS (Bottom Operator Button)

language choice is highlighted. Press the return to the

Select

OPTIONS MENU

FDT main menu

OPTIONS (2nd Operator Button from the top)

to change instrument default settings.

GREEN Button

when the desired

three times to

from the

Select

NEXT CHOICE (3rd Operator Button from the top)

setting to change. Select

TOGGLE ON/OFF (Top Operator Button)

change the highlighted setting. The settings include:

AT EACH BUTTON PRESS

and

AUTO PRINT REPORT AFTER TEST

MAKE CLICK SOUND

to select the

are selected as defaults. Select

ACCEPT SETTINGS (BOTTOM Operator Button)

options are set. Press the

MAIN MENU

Select

RESET TO DEFAULTS (3rd Operator button from the top)

SET-UP OPTIONS MENU

GREEN Button

and

ACCEPT SETTINGS

three times to return to the

to restore th e options to factory defaults. Press the times to return to the

FDP MAIN MENU

when the desired

in the

OPTIONS MENU

GREEN Button

SET-UP

. Both

FDT

in the

three

26 / SET UP & MAINTENANCE HUMPHREY FDT VISUAL FIELD INSTRUMENT

REV. D 01/00 PN 112098-1

FREQUENCY DOUBLING TECHNOLOGY MAIN MENU RUN PATIENT TESTS

RUN DEMONSTRATION

ADVANCE PAPER

UTILITIES MENU

24 JUN 1997 04:00 pm

Calibration

This instrument does not require scheduled calibration. The instrument calibration is 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. If not calibrated when the needs calibration warning is displayed, the unit will continue to operate normally until the unit reac hes the ca libra tion li mits. Once the c alibra tion l imits are rea ched, the unit will not operate normally until a calibration is completed successfully. Calibration may be performed at any ti me, not only when requested by the instrument.

To calibrate the instrument, select

Button)

from the

FDT MAIN MENU

(2nd Operator Button from the top)

UTILITIES MENU (BOTTOM Operator

and then

in the

RUN SELF-CALIBRATION

UTILITIES MENU

. Follow the Operator LCD Display instructions to start the calibration. The calibration will take several minutes and requires no operator interaction during calibration. If the calibration cannot be completed successfully, repeat the

CALIBRATION

sequence again (up to 3 times). If SELF-CALIBRATION cannot

RUN SELF-

be completed after 3 attempts, record the information on Operator LCD Display and contact an authorized customer service representative for assistance.

UTILITIES MENU

SET-UP INSTRUMENT MENU

RUN SELF-CALIBRATION

INSTRUMENT TESTS MENU

ABOUT FREQUENCY DOUBLING TECHNOLOGY

24 JUN 1997 04:01 pm

CALIBRATION AND SET-UP,

MAINTENANCE AND

TROUBLESHOOTING

Note

: Be sure to

cover

the

Patient Eyepiece

with the Calibration Cap shipped with each unit. If the Calibration Cap is not available, substitute something that will temporaril y block light from entering the Pati ent Ey epiece or perform the calibration in a completely darkened room (black cloth over Patient Visor, etc.). The Operator LCD Display will indicate if there is too much ambient light to complete the calibration.

HUMPHREY FDT VISUAL FIELD INSTRUMENT SET UP & MAINTENANCE / 27 REV. D 01/00 PN 112098-1

Softw are Upgrade

This instrument is designed with the ability to upgrade the operating software. For detailed software upgrade information, reference the software upgrade instructions available from authorized representatives.

The cur r en t s oftware version is available in the the bottom of the each

RESULTS PRINT-OUT.

ABOUT FDT SCREEN

and on

MAINTENANCE

This instrument requires no preventive inspection or maintenance. The only user maintenance re quired is replacing th e printer pa per and s urfa ce cleanin g as necessary.

Printer Paper Replacement

REF 11260

To load a new roll of paper, pull down the Operator LCD Display) using the Finger Tabs on the sides of the door (near the top). Remove the empty paper spool from the paper well.

Unwrap the paper from its bag, loosen the leading edge of the paper from the roll, and place the new roll of paper into the paper well with the

edge of the paper facing toward the outside

the diagram on the inside of the printer door).

Paper Access Door

of the unit (toward you – see

(below the

leading

CALIBRATION AND SET-UP,

MAINTENANCE AND

TROUBLESHOOTING

Place the leading edge of the paper onto the metal bar and push it into the unit under the roller bar. The instrument will automatically feed the paper through once you have inserted it far enough.

28 / SET UP & MAINTENANCE HUMPHREY FDT VISUAL FIELD INSTRUMENT

REV. D 01/00 PN 112098-1

Close the P aper A ccess Door, being sure the paper is sti c ki ng out thro ugh the slot in the door. Tear off any excess paper if desired.

: The printer paper can be advanced by selecting

Note Operator Button from the top)

in the results menu or by selecting

FEED (3rd Operator Button from the top)

FREQUENCY DOUBLING TECHNOLOGY MAIN MENU

RUN PATIENT T ESTS

RUN DEMONSTRATION

ADVANCE PAPER

in the

PAPER FEED (2nd

FDT MAIN MENU

PAPER

UTILITIES MENU

: Use only an appropriate heat-sensitive printer paper designed to be

Note

24 JUN 1997 04:08 pm

used with the Seiko Instruments 5000 series printer inside the instrument (reverse wound rolls only) or the print quality may be degraded, the printer life may be shortened, and the instrument warranty voided. Appropriate paper may be ordered through any authorized representative. Refer to the Replacement Parts and Accessories section of this manual for part number and ordering information.

: Because the printer pa per is thermally ac tivated , no printing will appe ar

Note

on the paper if it is inserted backwards.

: The printer paper is thermally activated, so it must be stored in a cool,

Note

dry, dark location to prevent exposure and degraded performance over time. Note: Do not use transparent adhesive tape on printed portions of the

printout, as those portio ns of the printo ut will then fade.

: Do not store the printed side of the printout in contact with plastic

Note

folders or sheets, as those portions of the printout will then fade.

: Do not allow any cleaning or disinfection solutions or other liquids to

Note

come into contact with the printer paper. Degraded print quality or printer damage may occur for new printouts and degraded printouts of previously printed results may occur (especially with Isopropyl alcohol).

CALIBRATION AND SET-UP,

MAINTENANCE AND

TROUBLESHOOTING

HUMPHREY FDT VISUAL FIELD INSTRUMENT SET UP & MAINTENANCE / 29 REV. D 01/00 PN 112098-1

FDT Replacement Parts and Accessories DESCRIPTION REF

FDT - Printer Paper (box of 5) . . . . . . . . . . . . . . . . . . . .11260

FDT - Calibration Cap . . . . . . . . . . . . . . . . . . . . . . . . . .112078-1

FDT - Computer Interface Cable . . . . . . . . . . . . . . . . . .11228

FDT - Patient Response Button. . . . . . . . . . . . . . . . . . .11229

Fuse - Type T .315A 250V(115V, 2 required). . . . . . . . . .236706-3112

Fuse - Type T .160A 250V (230V, 2 required). . . . . . . . .236706-3109

Power Cord - USA, Japan, Canada. . . . . . . . . . . . . . . . .76400

Power Cord - Europe . . . . . . . . . . . . . . . . . . . . . . . . . .76402

Power Cord - United Kingdom . . . . . . . . . . . . . . . . . . .76404

Power Cord - Australia. . . . . . . . . . . . . . . . . . . . . . . . . .76406

FDT - User’s Guide - English . . . . . . . . . . . . . . . . . . . . .112098-1

FDT - User’s Guide - French. . . . . . . . . . . . . . . . . . . . . .112098FR-1

FDT - User’s Guide - German . . . . . . . . . . . . . . . . . . . .112098GR-1

FDT - User Guide - Italian . . . . . . . . . . . . . . . . . . . . . . .112098IT-1

FDT - User’s Guide - Spanish. . . . . . . . . . . . . . . . . . . . .112098SP-1

FDT - Quick Reference Guide - English . . . . . . . . . . . . .112136

FDT - Quick Reference Guide - French . . . . . . . . . . . . .112136FR

FDT - Quick Reference Guide - German . . . . . . . . . . . .112136GR

FDT - Quick Reference Guide - Italian . . . . . . . . . . . . . .112136IT

FDT - Quick Reference Guide - Spanish . . . . . . . . . . . .112136SP

FDT - Service Manual . . . . . . . . . . . . . . . . . . . . . . . . . .112120

CALIBRATION AND SET-UP,

MAINTENANCE AND

TROUBLESHOOTING

FDT Product Model Numbers (710 SERIES)

DESCRIPTION REF

FDT - Domestic (115V) . . . . . . . . . . . . . . . . . . . . . . . . . 00710-11

FDT - Canada (115) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00710-21

FDT - Europe (230V) . . . . . . . . . . . . . . . . . . . . . . . . . . . 00710-31

FDT - France (230V) . . . . . . . . . . . . . . . . . . . . . . . . . . . 00710-41

FDT - Germany (230V). . . . . . . . . . . . . . . . . . . . . . . . . . 00710-51

FDT - Italy (230V) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00710-61

FDT - Spain (230V) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00710-71

FDT - United Kingdom (230V) . . . . . . . . . . . . . . . . . . . . 00710-81

FDT - Australia (230V) . . . . . . . . . . . . . . . . . . . . . . . . . . 00710-91

30 / SET UP & MAINTENANCE HUMPHREY FDT VISUAL FIELD INSTRUMENT

REV. D 01/00 PN 112098-1

Cleaning, Disinfection and Sterilization Cleaning

Clean the instrument as necessary by wiping the housing surfaces with a soft dry cloth or a soft cloth that has been water, 10% Clorox ™/water solution, or 70% Isopropyl alcohol. Clean the Patient Eyepiece window and Operator LCD Display window with a soft, lintfree cloth (do not use soap) or 70% Isopropyl alcohol.

dampened with commercially available window cleaners

lightly

dampened with soapy

lightly

Disinfection

Patient contact surfaces (the Forehead Rest and Patient Response Button) may be disin fected as necessary by wiping the surf ac es wi th a s oft cloth that has been lightly dampened with 10% Clorox™/water solution or 70% Isopropyl alcohol. Be sure to allow the surface to dry thoroughly before patient contact.

: Do not allow cleaning or disinfection solutions or other liquids to seep

Note

into the seams in the housings or along the LCD display or into the user Buttons. Do not spray cleaning or disinfection solutions or other liquids directly onto the instrument. Damage to internal components may occur.

: Do not allow any cleaning or disinfection solutions or other liquids to

Note

Sterilization

CALIBRATION AND SET-UP,

MAINTENANCE AND

TROUBLESHOOTING

Do not sterilize the instrument or any of its components.

TROUBLESHOOTING

The

INSTRUMENT TESTS MENU

ability to test the instrument’s inputs, outputs, serial port and A/D circuitry, if needed, for troubleshooting. Follow the menu choices to test the area of concern.

If the unit fails to power on confirm

Note

for instr uct ions to se lect the pro per opera ting v oltage or to ins pect or change the fuses.

If the instrument does not print out the results, confirm the foam shipping wedge has been removed

below the Op erator LCD Displa y) usin g the Finge r Tabs on the sides (near the top) and the printer door. Be sure the paper is sti cking out through the slot in the door.

• Approved power cord is connected to a power outlet and to The instrument Power Cord Inlet

• Power Switch is on

• Operator LCD Display contrast is set to allow the display to be visible (use the triangular Up/Down Contrast Adjustment Buttons)

• Proper operati ng v ol tage selec tion

• Power outlet is live

• Fuses condition

: Refer to the Preparation for Use and Power On section of this manual

remove the foam shipping wedge

(from the

(Operator LCD Display is off, no double beep),

(I)

. Pull down the

UTILITIES MENU

Paper Access Door

if not already removed. Close

provides the

HUMPHREY FDT VISUAL FIELD INSTRUMENT SET UP & MAINTENANCE / 31 REV. D 01/00 PN 112098-1

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

If the results pr int out is blank

printouts will occur if the printer paper is inserted backwards. Also, confirm the correct type printer paper is bei ng u sed. Imp rope r pap er type may cause blank or faint printouts. Refer to the Printer Paper Replacement section of this manual for instructions.

If you have an instrument problem that you cannot resolve, refer to the Service Information section of this manua l for Technical Assistance information

, confirm the paper is i nserted cor rectly. Blank

CALIBRATION AND SET-UP,

MAINTENANCE AND

TROUBLESHOOTING

32 / SET UP & MAINTENANCE HUMPHREY FDT VISUAL FIELD INSTRUMENT

REV. D 01/00 PN 112098-1

WARRANTY AND SE RVICE INFORMATION

WARRANTY INFORMATION

Zeiss Humphrey Systems warrants the Humphrey FDT Visual Field Instrument, when new, to be free from defects in materials and workmanship and to perform in accordance with manufacturer’s specifications for a period of one year from the date of purchase from Zeiss Humphrey Systems or its authorized distributors or agents.

Zeiss Humphre y S y stems w ill eithe r repair or replac e an y compone nts f ound d ef ectiv e or at v ariance from manufacturer’s sp ecifications wit hin this time at no cost to the customer. It shall be the purcha ser’s responsibility to ret urn th e inst r umen t direc tly to the regi onal authori ze d Service Center. This warranty does not include breakage or failure due to tampering, misuse, neglect, accidents, modifications or shi pping. T his w ar ran ty is also v oi d if the i nst r umen t is not us ed in a ccordan ce wi th manufacturer’s recommendations or if it is repaired by other than Zeiss Humphrey Systems or an authorized agent. Purchase date determines warranty.No other express warranty is given.

SERVICE INFORMATION

SERVICE or REPAIR to be PERFORMED by QUALIFIED, A UTHORIZED

PERSONNEL ONLY.

Disassembly of the instrument beyond the extent required to change the PRINTER PAPER, FUSES, or PATIENT RESPONSE BUTTON as described in this manual presents a possible electrical shock hazard and will void the warranty.

There are

NO USER SERVICEABLE PARTS INSIDE

the instrument.

All repairs on products under warranty must be performed or approved by an authorized service location. repaired by an authorized service location or other qualified electronics personnel.

Unauthorized repairs will void the warranty.

Products out of warranty should be

Technical Assistance Information

If you have an instrument problem that you cannot resolve, call the authorized service center listed below f or as si stance. Technical service support is a vailable during normal business hours on normal business days at the authorized service location phone numbers listed below.

Zeiss Humphrey Systems

5160 Hacienda Drive Dublin, California 94568

• 877-486-7473 • Fax: 925-557-4101

For custome rs outside of the US A, contact yo ur nearest Humphre y/Zeiss au thorize d service location or distributor for assistance .

WARRANTY AND SER VICE

INFORMA TION

HUMPHREY FDT VISUAL FIELD INSTRUMENT WARRANTY & SERVICE INFORMATION / 33 REV. D 01/00 PN 112098-1

WARRANTY AND SERVICE

INFORMATION

34 / WARRANTY & SERVICE INFORMATION HUMPHREY FDT VISUAL FIELD INSTRUMENT

REV. D 01/00 PN 112098-1

TECHNICAL SPECIFICATIONS

This instrument is manufactured exclusively for ZEISS HUMPHREY SYSTEMS by:

Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, New York 13153-0220 USA

INSTRUMENT SPECIFICATIONS

Dimensions Weight Patient display size Power requirements Power Connection Power Cord Computer Interface Printer

ENVIRONMENTAL SPECIFICATIONS Operating Conditions

Operating Temperature: +15° C to +35° C [+59° F to +95° F] Operating Humidity: 10% to 90% non-condensing Operating Altit ude : 500 hPa to 1060 hPa

: 25 cm [10''] wide x 48 cm [19''] deep x 43 cm [17''] high

: less than 9 kg [20 lbs.]

: 40° horizontal by 40° vertical square

: 100-120 VAC/220-240 VAC, 50/60 Hz, 50 Watts maximum

: IEC-320 standard power inlet connector for worldwide use

: Approved hospital grade detachable power cord

: RS-232 Serial, 9-pin D male connector, null-modem cable

: High-speed, high-resolution internal thermal printe r

Storage and Shipping Conditions

Storage Temperature: -20° C to +49° C [-4° F to +120° F] Storage Humidity: 0% to 95% non-condensing Storage Altitude: 500 hPa to 1060 hPa

SPECIFICATIONS

TECHNICAL

HUMPHREY FDT VISUAL FIELD INSTRUMENT TECHNICAL SPECIFICATIONS / 35 REV. D 01/00 PN 112098-1

TEST SPECIFICATIONS Screening Test Strategy:

• Supra-threshold 20°

•• Contrast values: p = 1% (2 times), p = 0.5%, maximum contrast

(SCREENING C-20)

Threshold Test Strategies:

• Full Threshold 20°

• Full Threshold Nasal 30°

• MOBS computer automated staircase thres ho ldi ng procedure

•• Initial Contrast: p = 0.5% contrast level

•• Staircase completion consists of at least four staircase reversals as well as upper and lower staircase boundaries within 0.3 log

•• MOBS threshold is calculated to be the mean of the last upper and last lower presentations satisfying the staircase completion criteria.

(FULL THRESHOLD C-20)

(FULL THRESHOLD N-30)

units of each other.

Reliability In d i ce s :

• Fixation Monitoring: Heijl-Krakau fixation monitor

•• Catch trial contrast: 6 dB (~ 50%)

•• 3 catch trials in

•• 6 catch trials in

•• Presentation Order: Pseudo-Random

•• Pattern: 1° diameter circular FDT stimulus

• False Positive Catch Trials:

•• Catch trials contrast: 56 dB (~ 0%)

•• 3 catch trials in

•• 6 catch trials in

•• 8 catch trials in

•• Presentation Order: Pseudo-Random

• False Negative Catch Trials:

•• Catch trial contrast 0 dB (~ 100%)

•• 3 Catch trials in

•• 5 Catch trials in

•• Presentation Order: Pseudo-Random

•• Pattern: 1 of 17 FDT Patterns, Random

SCREENING C-20 TEST FULL THRESHOLD C-20

SCREENING C-20 TEST FULL THRESHOLD C-20 TEST FULL THRESHOLD N-30 TEST

FULL THRESHOLD C-20 TEST FULL THRESHOLD N-30 TEST

and

N-30 TESTS

TECHNICAL

SPECIFICATIONS

Stimulus:

• 17 FDT patterns plus OD and O S fixat ion ca tch trial patterns (4 patterns per visual field quadrant plus a centr a l 5° radius pattern)

• Presentation Order: Random

• Spatial Frequency: 0.25 cycles/degree, cosinusoidal modulation

• Temporal Frequency: 25 Hz counter-phase flicker

• Duration: 200 to 400 ms

• Color: black and white

• Mean Background Illumination: 100 cd/m

• Contrast Range: 56 dB (~ 0%) to 0 dB (~ 100%) in log

• Interstimulus Internal: 0 to 500 ms, Random

nominal

steps

Screening Test Results:

• Deviation Plot with 4 qualitative loss classifications (Within Normal Limits, Mild Relative Loss, Moderate Relative Loss, Severe Loss) based on age-related normative references

• reliability Indices: Fixation and False Positive Catch Trials ratios

Threshold Test Results:

• Threshold (dB) Plot

• Deviation Plot with 5 probability level classifications (P> = 5%, P < 5%, P<2%, P<1%, P<0.5%) based on age-related normative references

• MD (Mean Deviation) and PSD (Pattern Standard Deviation) statistical Global Indices values with 5 probability level classifications (P> = 5%, P<5%, P<2%, P<1%, P<0.5%) based on agerelated normative references

• Reliability Indices: Fixation, False Positive, and False Negative Catch Trials ratios

36 / TECHNICAL SPECIFICATIONS HUMPHREY FDT VISUAL FIELD INSTRUMENT

REV. D 01/00 PN 112098-1

STANDARDS COMPLIANCE Product Safety

Class 1 IXPO- ordinary equipment Continuous operation equ ipm ent

TYPE BF

patient response Button.

ETL listed to comply with UL 2601-1 (1994) (USA) ETL listed to comply with CSA C22.2 No. 601.1-M90 (Canada) ETL listed to comply with IEC 601-1(1988 & 1990, including A1 & A2; Part 1) CB certified to Medical Electrical Equipment EN60601-1 Amendment 2 by ETL

Indicates this is a Type B product with Type BF applied parts; the patient f orehead rest an d

Electromagnetic Compatibility (EMC)

FCC Part 15, Class A (USA) This device complies with CFR 47 Part 15 Class A of the FCC rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may

cause undesired operati on .

EN60601-1-2 (1993), IEC 601-1-2 (1993)

• EN55011 ISM Level B (Industrial/Scientific/Medical)

• EN61000-3-2 Harmonics

• EN61000-3-3 Fluctuations, Flicker

• EN61000-4-2 ESD, Criteria B

• EN61000-4-3 Radiated RF, Criteria A

• EN61000-4-4 EFT, Criteria B

• EN61000-4-5 Surge, Criteria B

SPECIFICATIONS

TECHNICAL

Regulatory Approvals

FDA 510(k) The CE mark on this device indicates it has been tested to and conforms with the provisions noted

within the 93/42/EEC Medical Device Directive. Authorized European Representativ e A d dre ss :

European Regulatory Manager Carl Zeiss Jena GmbH D-07740 Jena, Germany Tel: 49-3641-642567 • Fax: 49-3641-642815

HUMPHREY FDT VISUAL FIELD INSTRUMENT TECHNICAL SPECIFICATIONS / 37 REV. D 01/00 PN 112098-1

TECHNICAL

SPECIFICATIONS

38 / TECHNICAL SPECIFICATIONS HUMPHREY FDT VISUAL FIELD INSTRUMENT

REV. D 01/00 PN 112098-1

FDT QUICK REFERENCE GUIDE

Start Patient Test

FREQUENCY DOUBLING TECHNOLOGY MAIN MENU RUN PATIENT TESTS

RUN DEMONSTRATION

ADVANCE PAPER

UTILITIES MENU

24 JUN 1997 03:55 pm

Enter Patient’s Age

+10 YEARS AGE: 50

-10 YEARS

+1 YEAR

ACCEPT SETTING

ENTER PATIENT AGE

24 JUN 1997 03:55 pm

Video Screen Patterns

•Select

RUN PATIENT TESTS

• Enter the patient’s

AGE

from the

select

ACCEPT SETTING

FDT MAIN MENU

when correct AGE is

displayed

• Slide the

Note: Slide

•Place the

Patient Visor

the

right eye

Response Button

to the

the

Patient Visor

right eye test position

to the

left ey e test position

(this is to your right)

test

in the patient’s hand and show them how to

now to

press it

• Ask the patient to place their forehead on the

Patient Eyepiece

• Adjust the

at the

Video Screen

of the chair or table (or both) to obtain a comfortable

height

Forehead Rest

and look into

position for the patient

• Explain the Test Procedure to the Patient

“A demonstration of the test is running no w. Can you see the blac k dot in the center and the entire lit video screen? You need to stare at the black dot in the center of the screen during the entire test.”

“From time to time, you will see patterns of

vertical bars

patterns will

that will briefly appear in different areas of the screen. The

sometimes

very faint

flickering black and white

and at other times be

very distinct

You are not expected to see the bar patterns at all times. Each time you see the

flickering black and white vertical bars

the response button once

. Can you see these patterns in the

of one of the patterns,

demonstration r unn ing no w? You may practice now b y press ing the button to respond to the patterns.”

skip

press

RUN RIGHT EYE TEST

RUN SCREENING C-20 TEST

RUN FULL THRESHOLD C-20 TEST

RUN FULL THRESHOLD N-30 TEST

SKIP RIGHT EYE

GRN BUTTON CANCELS 24 JUN 1997 03:55 pm

RIGHT EYE TEST MENU

RUN LEFT EYE TEST

RUN SCREENING C-20 TEST

RUN FULL THRESHOLD C-20 TEST

RUN FULL THRESHOLD N-30 TEST

SKIP LEFT EYE

GRN BUTTON CANCELS 24 JUN 1997 03:55 pm

LEFT EYE TEST MENU

It is OK to blink and a good time to blink is when you press the response button. If you need to rest or ask questions during the test, you can pause the test at any time by pressing and holding down the response button. Do you have any questions? Do you understand how to take the test?”

“I will now start the test. There will be a few brief flashes and then the test will begin. Press the response button once each time you see the

black and white vertical bars

very faint. Please remember to

during the entire test.”

screen

• Select either or

TEST

RUN SCREENING C-20 TEST, RUN FULL THRESHOLD C-20

RUN FULLTHRESHOLD N-30 TEST

of one of the patterns, even if the bars are

stare at the black dot in the center of the

from the

RIGHT EYE TEST

MENU.

Note

• Slide the

: Select

: You can press the

SKIP RIGHT EYE before

test.

eye

GREEN Button

any time or to return to the

Patient Visor

to the

left eye test position

selecting a test to

Pause

FDT MAIN MENU

at the end of the right

skip

Cancel

the test at

eye test

•Select

RUN SCREENING C-20 TEST, RUN FULL THRESHOLD C-20 TEST

RUN FULL THRESHOLD N-30 TEST

: Select

Note

VIEW RIGHT

on the

Operator LCD Display

SKIP LEFT EYE

test and proceed to the

eye

LEFT EYE RESULTS

from the

LEFT EYE TEST MENU

, before selecting a test, to

results menu

to see the individual eye results

skip

flickering

the

right

the

left

HUMPHREY FDT VISUAL FIELD INSTRUMENT FDT QUICK REFERENCE GUIDE / 39 REV. D 01/00 PN 112098-1

PATIENT’S VIDEO SCREEN PATTERNS

40 / FDT QUICK REFERENCE GUIDE HUMPHREY FDT VISUAL FIELD INSTRUMENT

REV. D 01/00 PN 112098-1

5160 Hacienda Drive

Dublin, CA 94568

Tel: 877-Humphrey

(877-486-7473)

Printed in U.S.A. HUMPHREY FDT VISUAL FIELD INSTRUMENT

REV. D 01/00 PN 112098-1

Zeiss Humphrey FDT User manual

Specifications and Main Features

Frequently Asked Questions

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

SCREENING C-20 TEST RESULTS SAMPLE

CALIBRATION AND SET-UP,

CALIBRATION AND SET-UP

Set-up Instrument Options

Calibration

Softw are Upgrade

MAINTENANCE

Printer Paper Replacement

TROUBLESHOOTING

WARRANTY INFORMATION

SERVICE INFORMATION

Technical Assistance Information

WARRANTY AND SER VICE

TECHNICAL SPECIFICATIONS

INSTRUMENT SPECIFICATIONS

TECHNICAL