Page 1
Humphrey FDT
Model 710
User Manual
Page 2
ii
Copyright
©2013 Carl Zeiss Meditec, Inc. All rights reserved.
Trademarks
Humphrey and FDT are either registered trademarks or trademarks of Carl Zeiss Meditec,
Inc. in the United States and/or other countries.
All other trademarks used in this document are the property of their respective owners.
Humphrey FDT User Manual 2660021149532 Rev. B 2015-11
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Contents
(1) Safety Information ........................................................................1-1
Product Safety ...................................................................................................1-1
Symbols and Labels............................................................................................1-3
Protective Packing Symbols........................................................................1-4
Product Labels and Serial Number Location ...............................................1-4
External Device Equipment.................................................................................1-4
Standards ..........................................................................................................1-5
Product Compliance ..................................................................................1-5
Electromagnetic Compatibility (EMC)..................................................................1-5
Guidance and Manufacturer’s Declarations ........................................................1-6
(2) Introduction.................................................................................... 2-1
Intended Use .....................................................................................................2-1
Indications for Use.............................................................................................2-1
Essential Performance ...............................................................................2-1
About the User Manual.....................................................................................2-3
Instrument Overview ..........................................................................................2-3
Controls and Connectors ....................................................................................2-4
Instrument Components, Patient Side ........................................................2-5
Instrument Components, Operator Side .....................................................2-5
Instrument Components.....................................................................................2-6
FDT Overview.....................................................................................................2-6
Patient Video Screen Patterns ....................................................................2-7
iii
(3) Operation ....................................................................................... 3-1
Unpacking.........................................................................................................3-1
Preparation For Use and Power On.....................................................................3-2
Preparing for a Patient Test................................................................................3-6
Enter the Patient’s Age..............................................................................3-7
Prepare the Patient....................................................................................3-7
Patient Refraction......................................................................................3-7
Explain the Test Procedure to the Patient ...................................................3-8
Running a Screening or Threshold Patient Test...........................................3-9
Displaying and Printing the Test Results ...........................................................3-12
Using the RS-232 Serial Computer Interface .....................................................3-12
Understanding the Screening C-20 and N-30 Test Results.................................3-13
Understanding the Threshold C-20 and N-30 Test Results.................................3-15
Screening C-20 Test Result Sample ..........................................................3-18
Threshold C-20 Test Results Sample.........................................................3-19
Threshold N-30 Test Results Sample ........................................................3-20
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iv
(4) Calibration and Set-up ..................................................................4-1
Calibration and Set-up .......................................................................................4-1
Set Date and Time.....................................................................................4-1
Set-up Instrument Options.........................................................................4-2
Calibration ................................................................................................4-3
Software Upgrade .....................................................................................4-4
Maintenance .....................................................................................................4-4
Printer Paper Replacement ........................................................................4-4
Fuse Replacement .....................................................................................4-6
FDT Replacement Parts and Accessories .............................................................4-6
Cleaning, Disinfection, Sterilization and Disposal ................................................4-7
Cleaning ...................................................................................................4-7
Disinfection...............................................................................................4-7
Sterilization...............................................................................................4-7
Instrument Disposition .......................................................................................4-7
Troubleshooting.................................................................................................4-8
(5) Service Information ....................................................................... 5-1
Technical Assistance Information........................................................................5-1
(6) Specifications .................................................................................6-1
Instrument.........................................................................................................6-1
Environmental ...................................................................................................6-1
Operating Conditions ................................................................................6-1
Storage and Shipping Conditions...............................................................6-1
Test ...................................................................................................................6-1
Screening Test Strategies:..........................................................................6-1
Threshold Test Strategies: ..........................................................................6-1
Reliability Indices: .....................................................................................6-2
Stimulus:...................................................................................................6-2
Screening Test Results: ..............................................................................6-2
Threshold Test Results: ..............................................................................6-2
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Safety Information
(1) Safety Information
All operating personnel should be familiar with the general safety information in this
summary. Additional safety information may also be found throughout this manual.
Note: If a serious incident has occurred in relation to this medical device, to the user, or to
another person, then the user (or responsible person) must report the serious incident to
the medical device manufacturer or the distributor. In the European Union, the user (or
responsible person) must also report the serious incident to the Competent Authority in the
state where the user is established.
Summary
CAUTION: Before connecting the power cord to the appliance inlet, verify that the
voltage selector switch is correctly set (115 V or 230 V) to match the power
requirements in your region.
CAUTION: Always replace fuses with the same type and rating (T 0.400 A 250 V).
Refer to Fuse Replacement section for instruction on changing fuses.
CAUTION: Do Not Sterilize the instrument or any of its components.
1-1
CAUTION: After unpacking the instrument, pull down the printer door (below the
LCD display), using the finger cutouts on the sides of the door (near the top), and
remove the foam shipping wedge before using the printer. Close the printer door. Be
sure the paper is sticking out through the slot in the door. Failure to remove the
shipping wedge will result in improper operation of the printer.
CAUTION: Do not use the instrument near other equipment which produces strong
magnetic fields (such as MRI). The video monitor performance may be adversely
affected.
Product Safety
This instrument is classified as follows:
• Class I Equipment – Protection against electrical shock.
• Type BF – Degree of protection against electric shock of applied part (forehead rest
and Patient Response button).
• Ordinary Equipment (IPX0) – Degree of protection against ingress of liquids (none).
• Continuous Operation – Mode of operation.
WARNING: This device contains visual stimuli, including flickering light
and flashing patterns, between 5 and 65 Hz. Medical professionals need to
determine whether this device should be used for patients who may be
photosensitive, including those with epilepsy.
WARNING: To prevent electric shock, the instrument must be plugged into
an earthed ground outlet. Do not remove or disable the ground pin.
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1-2
Safety Information
CAUTION: Do not use the printer or the instrument with an extension cord or a
power strip (multiple portable socket outlet).
WARNING: Do not open the instrument covers. Opening the instrument
covers could expose you to electrical and optical hazards and will VOID
the warranty.
CAUTION: If a table is available, do not reconfigure system components on the table,
nor add non-system devices or components to the table, nor replace original system
components with substitutes not approved by Carl Zeiss Meditec. Such actions could
result in failure of the table height adjustment mechanism, instability of the table,
tipping and damage to the instrument, and injury to operator and patient.
WARNING: This instrument may cause ignition of flammable gases or
vapors. Do NOT use in the presence of flammable anesthetics such as
nitrous oxide, or in the presence of pure oxygen.
WARNING: The instrument itself is transportable and may be moved from
one location to another. However, if the instrument is placed on a power
table provided by CZM, do not move the table to another location while
the instrument and any other peripherals are placed on it. Doing so may
cause the system components to tip over and cause harm to the patient,
the operator, or others in the vicinity.
CAUTION: Avoid tipping. Do not use the instrument on an uneven or sloped surface.
Also, do not roll the instrument table in deep pile carpet or over objects on the floor
such as power cords. Failure to observe these precautions could result in tipping of
the instrument and/or table and resulting injury to operator or patient and damage
to the instrument.
CAUTION: (United States) Federal law restricts this device to sale by or on the order
of a licensed healthcare practitioner.
WARNING: SERVICE or REPAIR to be performed by QUALIFIED,
AUTHORIZED PERSONNEL ONLY. There are NO USER SERVICEABLE PARTS
INSIDE the Humphrey FDT instrument. Disassembly of the instrument
presents a possible ELECTRICAL SHOCK hazard and will VOID the warranty.
If the unit fails, contact CZM for instructions.
WARNING: REPLACEMENT PARTS and ACCESSORIES – Use only approved
replacement parts and accessories.
CAUTION: The appliance coupler is the main disconnect device of the instrument.
Position the instrument in such a way to have easy access to disconnect the
appliance coupler in case of an emergency.
CAUTION: In case of an emergency, disconnect the appliance coupler.
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Safety Information
Symbols and Labels
WARNING
CAUTION
WARNING: Follow instructions for use. Failure to read and follow instructions may result in hazards
that can lead to serious injury. Instructions may also describe potential serious adverse reactions
and safety hazards.
Type BF applied parts: The Patient Forehead Rest and Patient Response button.
1-3
~
O I
Alternating Current
Power: Off On
Manufacturer
Authorized European Community Representative
Serial number
Catalog number / part number
Model number
European Conformity
Disposal of the Product within the EU. Do not dispose via domestic waste disposal system or
communal waste disposal facility.
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1-4
Safety Information
Protective Packing Symbols
The protective packing symbols specify the handling requirements and the transport and
storage conditions.
Handling Requirements Transport and Storage Conditions
Fragile, Handle with Care Relative Humidity (10% to 90%, non-condensing)
Keep Dry
This end up Atmospheric Pressure Limits (700 hPa to 1060 hPa)
Product Labels and Serial Number Location
The Product label is on the side of the instrument. The Serial Number label is located on
the bottom of the instrument.
Temperature (-20 to +49 deg. C)
External Device Equipment
WARNING: To maintain patient safety, if the instrument is externally
connected to non-medical peripheral devices (i.e. printer, storage devices,
etc.), the complete system must continue to meet the applicable medical
requirements of IEC 60601-1 safety standard. This standard requires the
usage of an Isolation Transformer to power the non-medical peripheral
device if located within 1.5 m from the patient. If the peripheral device is
located outside the patient environment (beyond 1.5 m) and is connected
to the FDT 710, a separation device must be used or there shall be no metal
to metal connection between the non-medical peripheral device and the
FDT 710.
The person or the responsible organization connecting additional devices
or reconfiguring the system must evaluate the complete system to ensure
compliance to the applicable IEC 60601-1 requirements. The instrument
operator must not attempt to touch the patient and the peripheral device
simultaneously.
Failure to observe this warning could result in electrical shock to the
patient and/or operator.
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Standards
Product Compliance
Complies with 93/42/EEC Medical Device Directive.
Safety Information
1-5
OR
Complies with US and Canadian medical electrical system safety requirements.
Electromagnetic Compatibility (EMC)
CAUTION: MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding
EMC and needs to be installed and put into service according to the following EMC
information provided.
CAUTION: Portable and mobile RF communications equipment can affect medical
electrical equipment.
CAUTION: The use of accessories, transducers and cables other than those specified
may result in increased emissions or decreased immunity of the equipment.
CAUTION: The FDT should not be used adjacent to or stacked with other equipment.
CAUTION: DO NOT USE the instrument near other equipment that produces strong
magnetic fields (such as MRI). The video monitor performance may be adversely
affected.
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1-6
Safety Information
Guidance and Manufacturer’s Declarations
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The Humphrey FDT is intended for use in the electromagnetic environment specified below. The customer or user of the
Humphrey FDT should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonics
IEC 61000-3-2
Flicker
IEC 61000-3-3
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Humphrey FDT is intended for use in the electromagnetic environment specified below. The customer or user of the
Immunity Test
ESD
IEC 61000-4-2
Group 1 The Humphrey FDT uses RF energy only for its internal function. Therefore, its
RF emissions are very low and are not likely to cause any interference in
nearby electronic equipment.
Class B The Humphrey FDT are suitable for use in all establishments including
domestic and those directly connected to the public low-voltage power sup-
Class A
Complies
Humphrey FDT should assure that it is used in such an environment.
IEC 60601
Test Level
± 6kV Contact
± 8kV Air
ply network that supplies buildings used for domestic purposes.
Compliance Level
± 6kV Contact
± 8kV Air
Electromagnetic Environment -
Guidance
Floors should be wood, concrete, or ceramic
tile. If floors are synthetic material, the relative
humidity should be at least 30%.
EFT
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage Dips, short
interruptions, and
voltage variations on
power supply input
lines.
IEC 61000-4-11
Power Frequency
50/60Hz
Magnetic Field
IEC 61000-4-8
Humphrey FDT User Manual 2660021149532 Rev. B 2015-11
±2kV Mains
±1kV I/O
±1kV Differential
±2kV Common
>95% Dip in 0.5
Cycle
60% Dip in 5 Cycles
30% Dip for 25
Cycles
>95% Dip in
5 Seconds
3 A/m 3 A/m Power frequency magnetic fields should be at
±2kV Mains
Not Applicable
±1kV Differential
±2kV Common
>95% Dip in 0.5
Cycle
60% Dip in 5 Cycles
30% Dip for 25
Cycles
>95% Dip in
5 Seconds
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment. If the
user of the Humphrey FDT requires continued
operation during power mains interruptions, it
is recommended that the Humphrey FDT be
powered from an uninterruptible power supply
or battery.
levels characteristic of a typical location in a
typical commercial or hospital environment.
Page 11
Safety Information
Guidance and Manufacturer’s Declaration – Emissions
The Humphrey FDT is intended for use in the electromagnetic environment specified below. The customer or user of the
Humphrey FDT should assure that it is used in such an environment.
1-7
Immunity Test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601
Test Level
3 Vrms
150 kHz to 80MHz
(outside ISM
bands)
3 V/m
80 MHz to 2.5 GHz
Compliance
Level
V1 = 3 Vrms
E1 = 3 V/m
Electromagnetic Environment - Guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the Humphrey
FDT, including cables, than the recommended separa-
tion distances calculated/listed below:
3.5
d
--------
d
d
Where P is the max power in watts and d is the rec-
ommended separation distance in meters.
Field strengths from fixed transmitters, as determined
by an electromagnetic site survey, should be less than
the compliance levels (3 Vrms and 3 V/m).
Interference may occur in the vicinity of equipment
P=
3
3.5
--------
P=
3
7
---
800 Mhz to 2.5 GHz
P=
3
containing a transmitter.
80 to 800 MHz
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1-8
Safety Information
Guidance and Manufacturer’s Declaration – Recommended Separations Distances between portable
and mobile RF Communications equipment and the Humphrey FDT
The Humphrey FDT is intended for use in the electromagnetic environment in which radiated disturbances are controlled.
The customer or user of the Humphrey FDT can help prevent electromagnetic interference by maintaining a minimum dis-
tance between portable and mobile RF Communications Equipment (transmitters)and the Humphrey FDT as recommended
below, according to the maximum output power of the communications equipment.
Separation (m)
Max Output Power
(watts)
150kHz to 80MHz
d 1.167P=
0.01 0.11667 0.11667 0.23333
0.1 0.36894 0.36894 0.73785
1 1.1667 1.1667 2.3333
10 3.6894 3.6894 7.3785
100 11.667 11.667 23.333
Separation (m)
80 to 800MHz
d 1.167P=
Separation (m)
800MHz to 2.5GHz
d 2.3333P=
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Introduction
(2) Introduction
Intended Use
Humphrey FDT is an AC-powered device intended to determine the extent of the peripheral
visual field of a patient. The device is intended to determine the amount of visual field loss
in a patient, which can then be used to diagnose/track the progression of glaucoma and
other eye diseases.
Indications for Use
Humphrey FDT is an AC-powered device intended to determine the extent of the peripheral
visual field of a patient. The device is intended to determine the amount of visual field loss
in a patient, which can then be used to diagnose/track the progression of glaucoma and
other eye diseases.
Note: These perimetry results are an aid to interpretation, not a diagnosis. The doctor’s
judgment is still the most important element in determining the clinical significance of
the results, including considering the limitations of the statistical package.
2-1
Essential Performance
The main essential performance of the instrument is to provide accurate visual field
mapping.
Patient Population
The Humphrey FDT may be used on all adults in need of diagnostic evaluation of the eye.
This includes (but is not limited to) patients with the following disabilities or challenges:
• Wheelchair user
• Very low or not measurable visual acuity
• Fixation problems
• Deafness
• Large body, but not those above 99th percentile based on anthropomorphic data
There is a general requirement that the patient be able to sit upright and be able to place
their face in the forehead rest of the instrument (with or without supplemental human or
mechanical support).
Part of the Body
The Humphrey FDT physically interacts with the patient’s forehead and chin. The patient's
hand and fingers (or similar ability) are also required to press the Patient Response button.
Application
The Humphrey FDT is designed for continuous use, although it is expected that most sites
operate the instrument for 10 hours or less per day, indoors, within a medical office or
hospital setting. This setting shall have clean air free of soot, vapors from adhesives,
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2-2
Introduction
grease, or volatile organic chemicals. Other Operating Environment specifications are given
in Chapters 1 and 6, Safety and Specifications. Application related warnings are given in
this chapter and elsewhere.
User Profile
We assume that users are clinicians with professional training or experience in the use of
ophthalmic equipment, and in diagnostic interpretation of the tests. Specific assumptions
regarding the profiles of individuals performing instrument operation or data interpretation
are given below. This manual contains information that will aid in the proper instrument
operation and interpretation of the resultant data.
Instrument Operation
Demographic
The user should be adult, and at least one of the following:
• Ophthalmologist or other Medical Doctor
• Optometrist or equivalent
• Nurse
• Certified Medical Technician
• Ophthalmic Photographer
• Non-certified Assistant
Occupational Skills
The user should be able to perform all of the following tasks:
• Power on the instrument
• Enter, find, and modify patient identifying data
• Clean surfaces that contact patient
• Instruct the patient
• Align the patient with the instrument
• Select and initiate a test
• Review and save a test or try again
• Generate an analysis report
• Review the analysis report for completeness
• Save, print, or export the analysis report
• Archive data
• Power off the instrument
Data Interpretation
Demographic
The user should be one of the following:
• Ophthalmologist or other Medical Doctor
• Optometrist or equivalent
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Introduction
Job Requirements
The user should have training and certification in the analysis and treatment of ophthalmic
diseases or other eye-related medical issues as required by governing bodies.
About the User Manual
The User Manual is designed to help you understand the capabilities and operation of the
Humphrey FDT Visual Field Instrument with 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.
2-3
Instrument Overview
The FDT Visual Field Instrument is an innovative, efficient, compact and affordable
automated visual field testing instrument. Years of research and clinical trials of 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
• 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 6D 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
• Software upgrade capability for future enhancements
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2-4
Introduction
Controls and Connectors
LCD Display Contrast – Use the UP and DOWN arrows adjacent to the contrast symbol
below the LCD display to adjust the LCD contrast for optimum viewing, based on lighting
conditions.
Patient Response
Button Connector
Software Upgrade
Connector
Computer
Interface
Connector
Serial Number
Location
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.
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Instrument Components, Patient Side
Forehead Rest
Introduction
2-5
Patient Eyepiece
Power Cord
Voltage Selector
Indicator
Patient Visor
Power Switch
Power Cord Inlet
Patient Response Button
Instrument Components, Operator Side
Calibration Cap
Operator Control
Panel
Operator Buttons
(Blue)
Cancel/Backup
Button (Green)
Paper Access Door
Finger Tab
Paper Access Door
Operator LCD
Operator LCD Display
Contrast Adjustment
Buttons
Printer Paper
Paper Access Door
Finger Tab
Paper Printout Slot
Paper Release Lever
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2-6
Introduction
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
FDT isolates a subset of retinal ganglion cell mechanisms in the magnocellular (M-cell)
pathway. 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.
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Patient Video Screen Patterns
Introduction
2-7
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2-8
Introduction
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Operation
(3) Operation
Unpacking
Personnel using this instrument should read and understand the operating instructions
manual before using the instrument. Interpretation of the results should be performed only
by appropriately trained eyecare professionals.
Open the shipping box by carefully cutting the packing 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 out of the remaining foam insert by grasping the
instrument at the two cutouts provided 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)
3-1
• Patient Response Button
• Power Cord (appropriate for local operating voltage)
• Extra roll of paper
Note: 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, pull down the Paper Access Door (below the LCD display)
using the Finger Tabs on the sides of the door. Remove the foam shipping wedge
using the printer. Close the Paper Access door while guiding Printer Paper through the
Paper Slot in the door. Failure to remove the shipping wedge will result in improper
operation of the printer.
before
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3-2
Operation
Paper Access Door
Finger Tab
Preparation For Use and Power On
Patient Side
Tip
Paper Access Door
Finger Tab
Serial Number
Location
Operator Side
While facing the Patient Side of the FDT instrument, tilt the instrument to plug the Patient
Response Button connector into the small round connector jack. The jack is located
underneath the base of the unit (at the center) and near the patient response button
symbol.
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Operation
3-3
CAUTION: VERIFY OPERATING VOLTAGE SELECTION — The FDT voltage
selector switch is normally set to the appropriate operating voltage before
shipment (115 V or 230 V). Before applying power to the FDT, verify that the
Voltage Selector Indicator adjacent to the O/I Power Switch displays the
appropriate operating voltage (115 V or 230 V) in your region.
Voltage Selector Indicator
In case you need to change the operating voltage, make sure that the Power Cord is NOT
connected and use a flat screwdriver to pry open the Fuse Drawer Cover. Remove the Fuse
Carrier/Voltage Selector, by again using a flat screwdriver. Rotate the Fuse Carrier/Voltage
Selector so the proper voltage will be visible when the Fuse Drawer Cover 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.
In case you need to replace the fuses, remove the fuse carrier/voltage selector as described
above. Replace both fuses on the two sides of the fuse carrier with new fuses (Type T 0.400
A 250 V). Reinstall the fuse carrier making sure the voltage selection is correct.
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3-4
Operation
Power Switch
Fuse Carrier/Voltage Selector
Make sure that the two fuses are inserted so that they are closest to the protruding metal flanges.
Selected Voltage
Fuse Drawer Cover
Plug the appropriate approved Power Cord into the Power Cord Inlet on the operator’s
right-hand side and plug the opposite end into a standard power outlet.
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Operation
3-5
Power Switch
Power Cord Inlet
To turn the instrument ON, switch the Power Switch (O/I), adjacent to the power connector,
to the ON (I) position. The instrument will perform internal self-diagnostic checks and after
approximately 15 seconds, two double beeps will sound and the FDT MAIN MENU will
appear on the Operator LCD Display. Refer to the troubleshooting section of this manual if
the FDT MAIN MENU does not appear.
Note: You may need to adjust the LCD contrast in order to read the Operator LCD
Display; use the triangle shaped buttons below the Operator LCD Display to increase
(up-arrow) or decrease (down-arrow) the LCD contrast.
FREQUENCY DOUBLING TECHNOLOGY MAIN MENU
RUN PATIENT TEST
RUN DEMONSTRATION
ADVANCE PAPER
UTILITIES MENU
24 JUN 1997 04:08 PM
Increase Contrast
Return to Main Menu Decrease Contrast
Note: the GREEN Button may be used at any time to back-up to the previous menu and
to return to the FDT MAIN MENU (it may need to be pressed several times to reach the
FDT MAIN MENU.
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3-6
Operation
Preparing for a Patient Test
Remove the CALIBRATION CAP from the Patient Eyepiece. Replace the calibration cap on
the Patient Eyepiece when the instrument is not in use to minimize the accumulation of
dust and debris in the Patient Eyepiece.
Select RUN PATIENT TESTS from the FDT MAIN MENU to prepare for a SCREENING C-20
TEST, SCREENING N-30 TEST, THRESHOLD C-20 TEST or a THRESHOLD N-30 TEST.
There are two screening test programs. The N-30 Screening program adds two additional
test locations presented above and below the horizontal midline between 20 and 30
degrees eccentricity in the nasal visual field, like with the N-30 Threshold test. Also, there
are two screening level options for each screening program: the -5 (default) and -1. The
Screening C-20-5 and N-30-5 programs utilize the P=5% significance limit as the baseline
normal contrast level, whereas the Screening C-20-1 and N-30-1 programs utilize the
P=1% significance limit as the baseline normal contrast level. See the clinical example
and refer to the Primer for Frequency Doubling Technology for a further explanation of the
-5 and -1 screening level options.
To change the default screening level found in the SCREENING TEST MENU from the
C-20-5 & N-30-5 (5% level) programs to the C-20-1 & N-30-1 (1% level) programs,
follow these keystrokes:
==> UTILITIES MENU ==> SET-UP INSTRUMENT MENU
==> SET-UP OPTIONS MENU ==> SET DEFAULT SCREENING LEVEL
and use NEXT CHOICE and ACCEPT SETTINGS to select SCREENING - 1%
FREQUENCY DOUBLING TECHNOLOGY MAIN MENU
RUN PATIENT TESTS
RUN DEMONSTRATION
ADVANCE PAPER
UTILITIES MENU
24 JUN 1997 04:08 PM
Note: Once RUN PATIENT TESTS is selected, typical FDT stimulus presentations are
automatically displayed to demonstrate the test to the patient until the test actually
starts.
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Operation
Enter the Patient’s Age
The unit will start with an AGE of 50 years. Select +10 YEARS (TOP BLUE Button) to
increase the AGE by 10 year increments (e.g. to 60, 70, and so on). Select -10 YEARS (2nd
BLUE Button from the top) to decrease the AGE by 10 year increments. Select + 1 YEAR
(3rd BLUE Button from the top) to increase the AGE in 1 year increments to adjust to the
exact age of the patient (e.g. 51, 52, and so on). Select ACCEPT SETTING (BOTTOM BLUE
Button) when the correct AGE is displayed.
3-7
+10 YEARS
AGE: 50
- 10 YEARS
+1 YEAR
ACCEPT SETTING
ENTER PATIENT AGE
24 JUN 1997 04:08 PM
Slide the Patient Visor to the right eye test position (this is to your right when looking at the
patient from the operator’s side).
Note: If you want to skip the right eye (i.e., only test the left eye), then slide the Patient
Visor to the left eye test position now (this is to your left when facing the patient
from the operator’s side) and select SKIP RIGHT EYE.
Prepare the Patient
Place the Patient Response Button in the patient’s hand and show them how to press it.
Ask the patient to place their forehead on the Forehead Rest and look into the Patient
Eyepiece at the video screen. Adjust the height of the chair or table (or both) to obtain a
comfortable position for the patient. Confirm that the patient can see the entire lit video
screen, including all four corners, in the Patient Eyepiece and the black dot in the middle of
the screen.
Note: Be sure the patient is positioned comfortably (not hunched over) by adjusting the
height of the chair or table (or both).
Patient Refraction
The FDT test may be taken with or without the patient’s correction (if the patient is within
6D of their refraction). If a patient is wearing glasses, confirm that their glasses frame does
not obscure any of the lit portion of the display. Ask the patient to remove their glasses for
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3-8
Operation
the test if their lenses or contact lenses are tinted or change contrast 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).
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 flickering black and white vertical bars that will
briefly appear in different areas of the screen. The patterns will sometimes be very faint 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 of one of the patterns, press
the response button once. Can you see these patterns in the demonstration running now?
You may practice now 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 flickering black and white vertical bars of
one of the patterns, even if the bars are very faint. Please remember to stare at the black
dot in the center of the screen during the entire test.”
Note: A separate demonstration test is available from the FDT MAIN MENU to help
facilitate the patient’s understanding of the test, if needed. To run a practice test, select
RUN DEMONSTRATION (2nd BLUE Button from the top) from the FDT MAIN
MENU. A demonstration of the test stimulus automatically begins. The patient should
use this time to become familiar with the test and practice using the PATIENT
RESPONSE BUTTON (Ask the patient to look into the Patient Eyepiece within the
Patient Visor and then test the procedure.) Press the GREEN Button to cancel the
practice test and return to the FDT MAIN MENU.
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FREQUENCY DOUBLING TECHNOLOGY MAIN MENU
RUN PATIENT TESTS
RUN DEMONSTRATION
ADVANCE PAPER
Operation
3-9
UTILITIES MENU
24 JUN 1997 04:08 PM
Be sure to prepare the patient as described above before running a practice test.
Running a Screening or Threshold Patient Test
Select either SCREENING TEST MENU or THRESHOLD TEST MENU from the RIGHT EYE TEST
MENU. If running a screening test, choose either RUN SCREENING C-20-1 (or -5) or RUN
SCREENING N-30-1 (or -5). If running a threshold test, choose either RUN THRESHOLD
C-20 or RUN THRESHOLD N-30. The right eye test will begin immediately after a
momentary check of the proper calibration..
Note: To skip the right eye test and proceed directly to the left eye test, select SKIP
RIGHT EYE (BOTTOM Operator Button from the top) before selecting a
SCREENING or THRESHOLD test.
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Operation
Note: The Operator LCD Display will indicate if there is too much ambient light to
perform a reliable test. Lower the room lighting or change the test location until suitable
test conditions are achieved. 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)
GRN BUTTON PAUSES 24 JUN 1997 04:05 PM
PERCENT COMPLETE:
2%
PATIENT RESPONSE : N
FIXATION ERRS : 0/0
FALSE POS ERRS : 0/0
FALSE NEG ERRS : 0/0
The PERCENT COMPLETE scale, field location being tested, PATIENT RESPONSE, FIXATION
ERRORS, FALSE POS ERRORS and FALSE NEG ERRORS are displayed on the Operator LCD
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 3 or 4 times during the test
to encourage good patient compliance. Monitor the catch trials (FIXATION ERRS, FALSE
POS ERRS, and FALSE NEG ERRS) during the test. The catch trial display fields will be
highlighted on the Operator LCD 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.
For the right eye, near the end of a SCREENING N-30 TEST or a THRESHOLD N-30 TEST, the
FDT will pause for approximately 15 seconds. The internal fixation target will move to the
right on the screen. This allows two extra nasal points to be tested. At the same time the
following instructions will appear on the screen: “Inform Patient Fixation Moved Right.”
Advise the patient to re-fixate on the black spot in its new position and continue to press
the Button until the test completes. The instruction will note fixation moved to the left
when testing the left eye.
Patient reliability (Fixation, False Positive, and False Negative) errors that exceed 1 are
highlighted on the operator LCD and marked with an asterisk (*) on the results printout.
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Operation
False Negative and False Positive catch trial presentations are indicated by the symbols (+)
& (-) on the operator LCD so they can be distinguished from regular teststimulus
presentations.
Note: You can PAUSE or RE-START the test by pressing the GREEN Button at any time
during the test. Follow the Operator LCD Display instructions to CONTINUE TEST or to
RE-START TEST from a pause. The patient can also PAUSE the test (for a break, etc.) by
simply pressing and holding down the Patient Response Button. The test will resume
automatically once the patient releases the Patient Response Button. During patient
pause, you may also select OPERATOR PAUSE (GREEN Button) so that the test will
remain paused until you restart it.
Note: A SCREENING C-20 TEST takes less than 1 minute (per eye) to complete, a
THRESHOLD C-20 TEST takes approximately 4 minutes (per eye) to complete and a
THRESHOLD N-30 TEST takes about 4-1/2 minutes.
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 left eye test position (this is to your left when facing the
patient from the operator’s side). Prepare the patient. Select RUN SCREENING C-20 TEST
(TOP Operator Button), RUN THRESHOLD C-20 TEST (2nd Operator Button from the top), or
RUN THRESHOLD N-30 TEST (3rd Operator Button from the top) from the LEFT EYE TEST
MENU to begin the left eye test immediately after a momentary check for proper
calibration.
3-11
LEFT EYE TEST MENU
RUN FULL THRESHOLD C-20 TEST
SKIP LEFT EYE
GRN BUTTON CANCELS 24 JUN 1997 04:10 PM
Note: To skip the left eye test, select SKIP LEFT EYE (Bottom Operator Button) to
proceed to the results menu.
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Operation
Displaying and Printing the Test Results
You can both view the results on the Operator LCD Display and print them out from the test
results 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 VIEW RIGHT EYE RESULTS (3rd Operator Button from the top) or VIEW LEFT
EYE RESULTS (Bottom Operator Button) to view the individual eye results for the patient just
tested on the Operator LCD Display. Use the GREEN Button to back-up to the previous
screen to allow you to toggle between the eye results or to return to the FDT MAIN MENU
(press it twice if necessary). Select 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).
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
FULL THRESHOLD C-20
Note: Once the test is completed, you can also select LAST PATIENT RESULTS (3rd
Operator Button from the top) from the FDT MAIN MENU to display or print out the
results of the patient just tested. The results of the most recently tested patient will
remain in memory only until you begin a new test or until the instrument power is turned
off.
Using the RS-232 Serial Computer Interface
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 instrument to a computer when the accessory computer interface
cable and software are used. For detailed information on using the computer interface,
reference the FDT PC operating instructions, available from authorized representatives.
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Operation
3-13
Understanding the Screening C-20 and N-30 Test Results
A plot of the 17 visual field locations tested will be printed (see samples on the following
pages) and displayed on the Operator LCD Display for the supra-threshold SCREENING
C-20 TEST for each eye tested. There are 19 visual field locations tested with the
SCREENING N-30 TEST. Each test location will be either clear white or will have one of
three possisble levels of shading.
A
“WITHIN NORMAL LIMITS” — The patient responded positively (on either the
A
first or second opportunity) when tested at the contrast level that 99% (P > =
1%) of normal subjects of the same age would respond to for the test location
with this shading.
B
B
“MILD RELATIVE LOSS” — The patient failed to respond positively when tested
at the 1% age normative contrast level (P = 1%) after being given 2
C
opportunities to do so (the instrument will re-test any point missed at the 1%
age normative level a second time) for the test location with this shading.
C
D
“MODERATE RELATIVE LOSS” — The patient failed to respond positively after
being given 3 opportunities to do so; twice at the 1% age normative contrast
level (P = 1%) and a third time at the 0.5% age normative contrast level (P =
0.5%) for the test location with this shading.
D
“SEVERE LOSS” — The patient failed to respond positively after being given 4
opportunities to 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.
When reviewing the results of the visual field test, careful consideration must be given to
the reliability indicators (catch trials). The following two test reliability indicators appear on
the printed 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 presented. For example, 1/3
indicates that the patient responded to 1 of the 3 catch trials presented.
FIXATION ERRS: 0/3
FALSE POS ERRS: 0/3
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). Three FIXATION catch trials will be randomly
presented for each eye. Fixation errors indicate the patient is not maintaining good fixation
during 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., no target presented) versus the total number of
“pauses” in the testing sequence. Three FALSE POSITIVE catch trials will be randomly
presented for each eye. 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.
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3-14
Operation
Because the FDT Screening N-30-1 (or C-20-1) and N-30-5 (or C-20-5) programs utilize
different baseline normal contrast levels, they also differ in how they flag (shade) test
locations as being outside normal limits. With the N-30-1 (or C-20-1) test, points are
initially flagged when they reach the P<1% probability significance level (i.e. the sensitivity
level which is found less than 1% of the time in the normal population). With the N-30-5
(or C-20-5) test, points are initially flagged when they reach the P<5% probability
significance level (i.e. the sensitivity level which is found less than 5% of the time in the
normal population), and thus there is a greater chance that any point may be deemed
outside normal limits. Therefore, the N-30-5 (or C-20-5) test is slightly more sensitive,
readily identifying more extensive loss. Below is a clinical example that demonstrates this
difference with a comparison between the Screening N-30-1 and N-30-5 programs.
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Operation
3-15
Understanding the 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 plot will be displayed on the Operator LCD Display for
the THRESHOLD C-20 and N-30 TEST for each eye tested. The first printed results plot will
contain a numerical contrast threshold level in units of dB for each location tested. The
second printed results plot is a deviation plot and will be either clear white or will have one
of four possible levels of shading corresponding age normative significance levels for each
location tested. The results combination plot displayed on the Operator LCD Display will
indicate both the numerical contrast threshold level and the shading for each location
tested.
A
The patient achieved a threshold level in the range that 95% (P > = 5%) of
A
B
C
D
E
normal subjects of the same age achieved for the test locations with this
shading.
B
The probability is less than 5% (P < 5%) that a normal subject of the same age
would perform at the threshold level that this patient achieved for the test
locations with this shading.
C
The probability is less than 2% (P < 2%) that a normal subject of the same age
would perform at the threshold level that this patient achieved for the test
locations with this shading.
D
The probability is less than 1% (P < 1%) that a normal subject of the same age
would perform at the threshold level that this patient achieved for the test
locations with this shading.
E
The probability is less than 0.5% (P < 0.5%) that a normal subject of the same
age would perform at the threshold level that this patient achieved for the test
locations with this shading. This shading will also occur if the patient failed to
respond at the maximum contrast level of the instrument (0 dB will be
indicated).
FIXATION ERRS: 0/0
FALSE POS ERRS: 0/0
FALSE NEG ERRS: 0/0
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 for 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, 1/3 indicates
that the patient responded to 1 of the 3 catch trials presented.
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-30 TEST. Fixation errors indicate the patient
is not maintaining good fixation during the test, is misaligned, or does not understand the
test.
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Operation
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
presented for each 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 ratio of the number of times the patient did not respond 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 patient is likely to not be paying attention,
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
Modified Binary Search (MOBS)
data (patient threshold scores) is between 0 dB Maximum Contrast (lowest patient
sensitivity) and 56 dB Minimum Contrast highest patient sensitivity). The formula used to
calculate the dB values is log
2048 (maximum contrast) and H is approximately 2. Note that XX dB will be displayed, if
the threshold cannot be determined due to inconsistent patient responses which do not
meet the MOBS threshold criteria. The magnitude of the threshold level values is directly
correlated to the Humphrey Field Analyzer values.
1
. The range of possible threshold level values for the raw
(2048/c)*10*H where c ranges from 1 (minimum contrast) to
10
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 overall information about the entire visual field. The
magnitude of the MD & PSD values are directly correlated to the Humphrey Field Analyzer
MD & PSD indices. The actual formulas used for the MD & PSD indices calculations can be
found in the references (2, 3).
“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.”
2
When the MD value is LESS than that of 95% of normal FDT fields, the percentile
probability is 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 PSD is small in a normal field, or in a field where all points
are equally abnormal. The PSD becomes large as some points are more affected than
others, and thus the PSD is an index of localized change in the field.”
3
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Operation
When the PSD value is GREATER than that of 95% of normal FDT fields, the percentile
probability is given (P < 5%, P < 2%, P < 1%, or P < 0.5%) on the Operator LCD Display
and on the printed report.
Pattern Deviation plots are displayed and printed with Threshold test results. Refer to the
Primer for Frequency Doubling Technology for information on Pattern Deviation plots.
3-17
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.
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3-18
Operation
Screening C-20 Test Result Sample
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Threshold C-20 Test Results Sample
Operation
3-19
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3-20
Operation
Threshold N-30 Test Results Sample
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Calibration and Set-up
(4) Calibration and Set-up
Calibration and Set-up
The UTILITIES MENU on the FDT MAIN MENU should not be needed 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).
Set Date and Time
To set the date and time, select UTILITIES MENU (BOTTOM Operator Button) from the FDT
MAIN MENU then select SET-UP INSTRUMENT MENU (TOP Operator Button) in the
UTILITIES MENU and select SET CLOCK MENU (TOP Operator Button) in the SET-UP
INSTRUMENT MENU.
UTILITIES MENU
SET-UP INSTRUMENT MENU
4-1
RUN SELF-CALIBRATION
INSTRUMENT TESTS MENU
ABOUT FREQUENCY DOUBLING TECHNOLOGY
SET-UP INSTRUMENT MENU
SET CLOCK MENU
SET-UP OPTIONS MENU
PRINT SET-UP REPORT
24 JUN 1997 04:01 pm
24 JUN 1997 04:01 pm
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4-2
Calibration and Set-up
Select NEXT CHOICE (3rd Operator Button from the top) to select the clock setting you
want to change. (s) INCREASE (TOP Operator Button) and (t) DECREASE (2nd Operator
Button from the top) to change the setting. Select ACCEPT SETTINGS (BOTTOM Operator
Button) when the correct CLOCK settings are displayed. Press the GREEN Button twice to
return to the FDT MAIN MENU.
SET CLOCK MENU
s INCREASE YEAR: 1997
MONTH: JUN
t DECREASE DAY: 24
HOUR: 4 pm
NEXT CHOICE MINUTE: 2
12 HOUR FORMAT
ACCEPT SETTINGS
24 JUN 1997 04:02 pm
Set-up Instrument Options
To SELECT LANGUAGE or OPTIONS, select SET-UP OPTIONS MENU (2nd Operator Button
from the top). Select SELECT LANGUAGE (top Operator Button) from the SET-UP OPTIONS
MENU to choose the desired language for the Operator LCD Display and results printout.
Use NEXT CHOICE (3rd Operator Button from the top) to select the desired language from
the list.
Select ACCEPT SETTINGS (Bottom Operator Button) when the desired language choice is
highlighted. Press the GREEN Button three times to return to the FDT main menu.
Select OPTIONS (2nd Operator Button from the top) from the SET-UP OPTIONS MENU to
change instrument default settings.
Select NEXT CHOICE (3rd Operator Button from the top) to select the setting to change.
Select TOGGLE ON/OFF (Top Operator Button) to change the highlighted setting. The
settings include: MAKE CLICK SOUND AT EACH BUTTON PRESS and AUTO PRINT REPORT
AFTER TEST. Both are selected as defaults.
Select ACCEPT SETTINGS (BOTTOM Operator Button) when the desired options are set.
Press the GREEN Button three times to return to the FDT MAIN MENU.
Select RESET TO DEFAULTS (3rd Operator button from the top) in the SET-UP OPTIONS
MENU and ACCEPT SETTINGS in the OPTIONS MENU to restore the options to factory
defaults. Press the GREEN Button three times to return to the FDP MAIN MENU.
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Calibration and Set-up
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 reaches the calibration limits. Once the calibration limits are reached, the unit will not
operate normally until a calibration is completed successfully. Calibration may be
performed at any time, not only when requested by the instrument.
To calibrate the instrument, select UTILITIES MENU (BOTTOM Operator Button) from the
FDT MAIN MENU and then RUN SELF-CALIBRATION (2nd Operator Button from the top) in
the 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 RUN
SELF-CALIBRATION sequence again (up to 3 times). If SELF-CALIBRATION cannot be
completed after 3 attempts, record the information on Operator LCD Display and contact
an authorized customer service representative for assistance.
4-3
UTILITIES MENU
SET-UP INSTRUMENT MENU
RUN SELF-CALIBRATION
INSTRUMENT TESTS MENU
ABOUT FREQUENCY DOUBLING TECHNOLOGY
24 JUN 1997 04:01 pm
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 temporarily
block light from entering the Patient Eyepiece 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.
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4-4
Calibration and Set-up
Software 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 current software version is available in the ABOUT FDT SCREEN and on the bottom of
the each RESULTS PRINT-OUT.
Maintenance
This instrument requires no preventive inspection or maintenance. The only user
maintenance required is replacing the printer paper and surface cleaning as necessary.
Printer Paper Replacement
To load a new roll of paper, pull down the Paper Access Door (below 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 leading edge of the paper facing
toward the outside of the unit (toward you – see the diagram on the inside of the printer
door).
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Calibration and Set-up
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.
Close the Paper Access Door, being sure the paper is sticking out through the slot in the
door. Tear off any excess paper if desired.
Note: The printer paper can be advanced by selecting ADVANCE PAPER (2nd Operator
Button from the top) in the results menu or by selecting ADVANCE PAPER (3rd
Operator Button from the top) in the FDT MAIN MENU.
4-5
FREQUENCY DOUBLING TECHNOLOGY MAIN
RUN PATIENT TESTS
RUN DEMONSTRATION
ADVANCE PAPER
UTILITIES MENU
MENU
Note: Use only an appropriate heat-sensitive printer paper designed to be 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.
Note: Because the printer paper is thermally activated, no printing will appear on the
paper if it is inserted backwards.
Note: The printer paper is thermally activated, so it must be stored in a cool, 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
portions of the printout will then fade.
Note: Do not store the printed side of the printout in contact with plastic folders or
sheets, as those portions of the printout will then fade.
Note: Do not allow any cleaning or disinfection solutions or other liquids to 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).
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4-6
Calibration and Set-up
Fuse Replacement
For fuse replacement, see page 3-4.
FDT Replacement Parts and Accessories
DESCRIPTION PART NUMBER
FDT - Printer Paper (box of 5) 2660021101300
FDT - Dust Cover 0000001096628
FDT - Calibration Cap 0000001034279
FDT - ViewFinder™ Software Kit* 0000001272153
FDT - Computer Interface Cable 0000001272743
FDT - Patient Response Button 0000001045678
FDT - Patient Response Button Holder 0000001054028
Fuse - Type T .400A 250V (2 required) 2660021131921
Power Cord - USA, Japan, Canada 2660100022511
Power Cord - Europe 0000001145999
Power Cord - United Kingdom 2660021133168
Power Cord - Australia 2660021131890
FDT - User Documentation Disk** 2660021134021
**Included on the Document Disk are the following FDT documents:
• User Manuals: EN, FR, IT, DE, ES
• Quick Reference Guides: EN, FR, IT, DE, ES
• Primer, English only
Note: Item part numbers and descriptions are subject to change.
To order: In the U.S., call 800-341-6968. Outside the U.S., contact your local Carl Zeiss
affiliate or distributor.
* ViewFinder Software is a PC-based application that enables the FDT exam to be serially
transferred to a local computer running the ViewFinder software. ViewFinder Software is
available as a kit and includes the software on CD, a serial cable, and instructions.
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Calibration and Set-up
Cleaning, Disinfection, Sterilization and Disposal
Cleaning
Clean the instrument as necessary by wiping the housing surfaces with a soft dry cloth or a
soft cloth that has been lightly dampened with soapy water, 10% Clorox™/water solution,
or 70% Isopropyl alcohol. Clean the Patient Eyepiece window and Operator LCD Display
window with a soft, lint-free cloth lightly dampened with commercially available window
cleaners (do not use soap) or 70% Isopropyl alcohol.
Disinfection
Patient contact surfaces (the Forehead Rest and Patient Response Button) may be
disinfected as necessary by wiping the surfaces with a soft 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.
Note: Do not allow cleaning or disinfection solutions or other liquids to seep 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.
4-7
Note: Do not allow any cleaning or disinfection solutions or other liquids to 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).
Sterilization
CAUTION: Do not sterilize the instrument or any of its components.
Instrument Disposition
When it comes time to upgrade the FDT, please contact Carl Zeiss Meditec to inquire about
trade-in or upgrade values we may offer. Should you not wish to trade in the instrument,
please dispose of it in accordance with local and national electrical and electronic
equipment recycling requirements.
Disposal
This product contains electronic components. At the end of its lifetime, the product should
be disposed of in accordance with the relevant national regulations.
Disposal of the Product within the EU
Packaging materials should be retained for future relocation or repair. If you wish to
dispose of the packaging material, contact a recognized collection system for recycling.
The device contains electronic components. At the end of its lifetime, the product and its
integrated batteries should be disposed of in accordance with the relevant national
regulations.
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4-8
Calibration and Set-up
In accordance with applicable EU guidelines and national regulations at the time at which
the product was brought onto the market, the product specified on the consignment note
is not to be disposed of via the domestic waste disposal system or communal waste
disposal facilities.
For further information on disposal of this product, please contact your local dealer or the
manufacturer or its legal successor company. Please read the latest Internet information
provided by the manufacturer.
Where the product or its components are resold, the seller must inform the buyer that the
product is to be disposed of in accordance with the currently applicable national
regulations.
Troubleshooting
The INSTRUMENT TESTS MENU (from the UTILITIES MENU) provides the 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 (Operator LCD Display is off, no double beep), confirm:
• Approved power cord is connected to a power outlet and to the instrument Power
Cord Inlet
• Power Switch is on (I)
• Operator LCD Display contrast is set to allow the display to be visible (use the
triangular Up/Down Contrast Adjustment Buttons)
• Proper operating voltage selection
• Power outlet is live
• Fuses condition
Note: Refer to the Preparation for Use and Power On section of this manual for
instructions to select the proper operating voltage or to inspect or change the fuses.
If the instrument does not print out the results, confirm the foam shipping wedge has been
removed. Pull down the Paper Access Door below the Operator LCD Display) using the
Finger Tabs on the sides (near the top) and remove the foam shipping wedge if not already
removed. Close the printer door. Be sure the paper is sticking out through the slot in the
door. Failure to remove the shipping wedge will result in improper operation of the printer.
If the results printout is blank, confirm the paper is inserted correctly. Blank printouts will
occur if the printer paper is inserted backwards. Also, confirm the correct type printer paper
is being used. Improper paper 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 manual for Technical Assistance information.
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Service Information
(5) Service Information
WARNING: Service or repair to be performed by qualified, authorized
CZMI-personnel only. There are no user serviceable parts inside the
instrument. 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.
All repairs on products under warranty must be performed or approved by an authorized
service location. Unauthorized repairs will void the warranty. Products out of warranty
should be repaired by an authorized service location or other qualified electronics
personnel.
Technical Assistance Information
If you have an instrument problem that you cannot resolve, call the authorized service
center listed below for assistance. Technical service support is available during normal
business hours on normal business days at the authorized service location listed below. For
customers outside of the USA, contact your nearest Carl Zeiss Meditec authorized service
location or distributor for assistance.
5-1
Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin, California 94568
1-800-341-6968
Fax: 925-557-4101
Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
07745 Jena, Germany
Phone: +49 36 41 22 03 33
Fax: +49 36 41 22 01 12
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5-2
Service Information
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Specifications
(6) Specifications
Instrument
Dimensions: 25 cm [10''] wide x 48 cm [19''] deep x 43 cm [17''] high
Weight: Less than 9 kg [20 lbs.]
Patient display size: 40° horizontal by 40° vertical square
Power requirements: 115/230 V~, 50/60 Hz, 0.4/0.2 A,
Power Connection: IEC-320 standard power inlet connector for worldwide use
Power Cord: Approved power cord
Computer Interface: RS-232 Serial, 9-pin D male connector, null-modem cable
Printer: High-speed, high-resolution internal thermal printer
Environmental
Operating Conditions
Temperature: +15° C to +35° C
Humidity: 10% to 90% non-condensing
Pressure: 700 hPa to 1060 hPa
Altitude: Up to 3000 m above sea level
6-1
Storage and Shipping Conditions
Temperature: -20° C to +49° C
Humidity: 0% to 95% non-condensing
Pressure: 700 hPa to 1060 hPa
Test
Screening Test Strategies:
• Supra-threshold 20° (SCREENING C-20 - 1)
• Contrast values: p = 1% (2 times), p = 0.5%, maximum contrast
• Supra-threshold 20° (SCREENING C-20 - 5)
• Contrast values: p = 5% (2 times), p = 1%, maximum contrast
• Supra-threshold 20° (SCREENING N-30 - 1)
• Contrast values: p = 1% (2 times), p = 0.5%, maximum contrast
• Supra-threshold 20° (SCREENING N-30 - 5)
• Contrast values: p = 5% (2 times), p = 1%, maximum contrast
Threshold Test Strategies:
• Threshold 20° ( THRESHOLD C-20)
• Threshold Nasal 30° ( THRESHOLD N-30)
• MOBS computer automated staircase thresholding 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 log10 units of each other.
• MOBS threshold is calculated to be the mean of the last upper and last lower presentations
satisfying the staircase completion criteria.
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6-2
Specifications
Reliability Indices:
• Fixation Monitoring: Heijl-Krakau fixation monitor
• Catch trial contrast: 6 dB (~ 50%)
• 3 catch trials in SCREENING C-20 and N-30 TESTS
• 6 catch trials in THRESHOLD C-20 and N-30 TESTS
• Presentation Order: Pseudo-Random
• Pattern: 1° diameter circular FDT stimulus
• False Positive Catch Trials:
• Catch trials contrast: 56 dB (~ 0%)
• 3 catch trials in SCREENING C-20 and N-30 TESTS
• 6 catch trials in THRESHOLD C-20 TEST
• 8 catch trials in THRESHOLD N-30 TEST
• Presentation Order: Pseudo-Random
• False Negative Catch Trials:
• Catch trial contrast 0 dB (~ 100%)
• 3 Catch trials in THRESHOLD C-20 TEST
• 5 Catch trials in THRESHOLD N-30 TEST
• Presentation Order: Pseudo-Random
• Pattern: 1 of 17 FDT Patterns, Random
Stimulus:
• 17 or 19 FDT patterns plus OD and OS fixation catch trial patterns (4 patterns per visual field
quadrant plus a central 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/m2 nominal
• Contrast Range: 56 dB (~ 0%) to 0 dB (~ 100%) in log10 steps
• Interstimulus Internal: 0 to 500 ms, Random
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
age-related normative references
• Reliability Indices: Fixation, False Positive, and False Negative Catch Trials ratios
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Page 54
Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin, CA 94568
USA
Toll Free: 1 800 341 6968
Phone: +1 925 557 4100
Fax: +1 925 557 4101
info@meditec.zeiss.com
www.meditec.zeiss.com
Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
07745 Jena
Germany
Phone: +49 36 41 22 03 33
Fax: +49 36 41 22 01 12
info@meditec.zeiss.com
www.meditec.zeiss.com
2660021149532 Rev. B 2015-11
Humphrey FDT User Manual
Specifications subject to change without notice
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