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Humphrey FDT Model 710 User Manual

1. Humphrey FDT Model 710 User Manual 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 Contents 1 2 3 Safety Information sn 1 1 Prod ctSalety a en br eee oce dali e eee ac 1 1 Symbols nd Eabels ceti etit dedicated ned veniet 3 Protective Packing SYMDOIS i2 ttf ec e eg n 4 Product Labels and Serial Number Location 4 External Device EQUIPMENT ireen nen de hieme enero as 4 Standards chiens er t UR ER ue E dae EET 5 Prod ct CoriplidriGe as za nct e a ee e 1 5 Electromagnetic Compatibility EM 5 Guidance and Manufacturer s Declarations cocoa 6 Introduction 2 1 Mende g USC 25 sire PP nd ee Pvt ttr d PU S 2 1 maraton TOF USB aries o NAE pee 2 1 Essential PEO MANE s de tea odo oe peat aient 2 1 About the UserMatiual s rie i e oet 2 3 Instrument OVERVIOW nn 5x ccr reet een Ee teen rr repre 2 3 Controls NU ConnectrS cicer ift fiin ete ten renes 2 4 Instrument Components Patient Side sss 2 5 Instrument Components Operator Side 2 5 Instrument COMPONENTS uarie Pre tere recte ree 2 6 EDO Ward eun B De Hei And den Gaara 2 6 Patient Video Screen Patterns 2 7 Operation m
2. 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 Humphrey FDT User Manual 2660021149532 A IOIO 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 Computer Software Upgrade ee Connector 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 t
3. 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 Humphrey FDT User Manual 2660021149532 A 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
4. 700 hPa to 1060 hPa Altitude Up to 3000 m above sea level Storage and Shipping Conditions Temperature 20 Cto 49 C Humidity 0 to 95 non condensing Pressure 700 hPa to 1060 hPa Test Screening Test Strategies e Supra threshold 20 SCREENING C 20 1 e Contrast values p 1 2 times p 0 5 maximum contrast Supra threshold 20 SCREENING C 20 5 e Contrast values p 5 2 times p 1 maximum contrast Supra threshold 20 SCREENING N 30 1 e Contrast values p 1 2 times p 0 5 maximum contrast Supra threshold 20 SCREENING N 30 5 e Contrast values p 5 2 times p 1 maximum contrast Threshold Test Strategies e Threshold 20 THRESHOLD C 20 e Threshold Nasal 30 THRESHOLD N 30 e MOBS computer automated staircase thresholding procedure e 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 units of each other e MOBS threshold is calculated to be the mean of the last upper and last lower presentations satisfying the staircase completion criteria Humphrey FDT User Manual 2660021149532 A Specifications Reliability Indices Fixation Monitoring Heijl Krakau fixation monitor e Catch trial contrast 6 dB 50 e 3 catch trials in SCREENING C 20 and N 30 TESTS e 6 catch trials in THRESHOLD C 20 and N 30 TEST
5. FALSE POS ERRS 0 6 FALSE NEG ERRS 0 3 MD 2 54dB PSD 275 dB Probability Symbols P gt 5 FIXATION ERRS 0 6 FALSE POS ERRS 0 6 P lt 5 FALSE NEG ERRS 0 3 lt 2 lt 1 lt 0 5 Humphrey FDT User Manual 2660021149532 A Operation Threshold N 30 Test Results Sample FULL THRESHOLD N 30 LEFT EYE NAME Test duration 04 40 min AGE 79 ID 30 JUN 1997 06 45 am Threshold dB RIGHT EYE Test duration 04 07 min 32 36 40 40 32 Threshold dB 36 34 33 34 34 36 33 32 36 36 A1 36 35 30 41 37 40 35 Deviation 37 31 45 40 40 36 36 40 40 36 30 8 Deviation a MD 4 07 dB PSD 4 01 dB FIXATION ERRS 0 6 FALSE POS ERRS 0 8 FALSE NEG ERRS 0 5 es er Probability Symbols P gt 5 FIXATION ERRS 0 6 FALSE POS ERRS 0 8 FALSE NEG ERRS 0 5 44914 P lt 5 P lt 2 P lt 1 P lt 0 5 Humphrey FDT User Manual 2660021149532 A Calibration and Set up PEE 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
6. 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 Separation m Separation m Max Output Power 150kHz to 80MHz 80 to 800MHz 800MHz to 2 5GHz oe d 1 167 P d 1 167 P d 2 3333 JP 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 1 3785 100 11 667 11 667 23 333 Humphrey FDT User Manual 2660021149532 A Introduction 21 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
7. 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 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 e Very low or not measurable visual acuity e Fixation problems Deafness e 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 Humphrey FDT User Ma
8. 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 Humphrey FDT User Manual 2660021149532 A Lx Calibration and Set up TEAN Cleaning Disinfection Sterilization and Disposal Cleaning Clean the instrument as necessary by wiping the housing surfaces with a soft dry cloth ora 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 Note Do not allow any cleaning or disinfection solutions or other
9. ii ii e tla AE AR ee 4 8 5 Service Information 5 1 Technical Assistance Information cnc 5 1 6 Specifications anni 6 1 Instrumenten ee o cda bm HR ene 6 Environmental seed t e tt tas tan ten UE el trt ipt d 6 Operating Conditions coccion 6 1 Storage and Shipping Conditions 6 1 i H H 6 Screening Test Strat gies ste ee toe ertet eb een 6 Threshold Test Strategies 6 Reliability INDICES crt rette tede e ote p s 6 2 Sur sese ar En 6 2 Screening Test Results eh eode eoe dp bn 6 2 Threshold Test RESUS svenn RR n Ue ted 6 2 Humphrey FDT User Manual 2660021149532 A Pr p gt Safety Information EMI 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 requiremen
10. 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 Humphrey FDT User Manual 2660021149532 A 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 d
11. location in a typical commercial or hospital environment Humphrey FDT User Manual 2660021149532 A Safety Information a Guidance and Manufacturer s Declaration Emissions The Humphrey FDT is intended for use in the electromagnetic envi Humphrey FDT s hould assure that it is u ronment specified below The customer or user of the sed in such an environment Immunity Test E Compliance Electromagnetic Environment Guidance Test Level Level 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 Conducted RF 3 Vrms V1 3 Vrms d 3 5 JP IEC 61000 4 6 150 kHz to B0MHz 3 outside ISM bands d 33 JP 8010800 MHz 3 Radiated RF 3 Vim El 3 Vim dis 2 JP 800 Mhzto 2 5 Ghz IEC 61000 4 3 80 MHz to 2 5 GHz 3 Where Pis 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 containing a transmitter Humphrey FDT User Manual 2660021149532 A Safety Information Guidance and Manufacturer s Declaration Recommended Separations Distances between portable and mobile RF Communications equipment and the Humphrey
12. 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 Humphrey FDT User Manual 2660021149532 A Operation EXT False Negative and False Positive catch trial presentations are indicated by the symbols amp 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 r
13. 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 Humphrey FDT User Manual 2660021 149532 A 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 equivalen
14. 1 P lt 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 gt 5 P lt 5 P lt 2 P lt 1 P lt 0 5 based on age related normative references Reliability Indices Fixation False Positive and False Negative Catch Trials ratios Humphrey FDT User Manual 2660021149532 A ml 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 EC REP Carl Zeiss Meditec AG Goeschwitzer Strasse 51 52 07745 Jena Germany Phone 449 36 41 22 03 33 Fax 49 36 41 22 01 12 info meditec zeiss com www meditec zeiss com CE 2660021149532 A Humphrey FDT User Manual Specifications subject to change without notice
15. 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 Humphrey FDT User Manual 2660021149532 A Safety Information IR Standards Product Compliance C Complies with 93 42 EEC Medical Device Directive ATERT LR 96697 El OR SP Complies with US and Canadian medical electrical system safety requirements c US LISTES C US Electromagnetic Compatibility EMC l 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 A 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
16. 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 RUN SELF CALIBRATION INSTRUMENT TESTS MENU ABOUT FREQUENCY DOUBLING TECHNOLOGY 24 JUN 1997 04 01 pm OVA SET UP INSTRUMENT MENU SET CLOCK MENU SET UP OPTIONS MENU PRINT SET UP REPORT 24 JUN 1997 04 01 pm OVA Humphrey FDT User Manual 2660021149532 A 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 4pm 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 w
17. S e Presentation Order Pseudo Random e Pattern 1 diameter circular FDT stimulus False Positive Catch Trials e Catch trials contrast 56 dB 0 e 3catch trials in SCREENING C 20 and N 30 TESTS e 6 catch trials in THRESHOLD C 20 TEST e 8catch trials in THRESHOLD N 30 TEST e Presentation Order Pseudo Random False Negative Catch Trials e Catch trial contrast 0 dB 100 e 3 Catch trials in THRESHOLD C 20 TEST e 5 Catch trials in THRESHOLD N 30 TEST e Presentation Order Pseudo Random e 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 m nominal Contrast Range 56 dB 0 to 0 dB 100 in logy 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 gt 596 P lt 5 P lt 2 P lt
18. SCREENING TEST MENU from the C 20 5 amp N 30 5 5 level programs to the C 20 1 amp N 30 1 1 level programs follow these keystrokes gt UTILITIES MENU gt SET UP INSTRUMENT MENU gt SET UP OPTIONS MENU gt SET DEFAULT SCREENING LEVEL and use NEXT CHOICE and ACCEPT SETTINGS to select SCREENING 1 FREQUENCY DOUBLING TECHNOLOGY MAIN MENU C RUN PATIENT TESTS o RUN DEMONSTRATION C ADVANCE PAPER UTILITIES MENU 24 JUN 1997 04 08 PM m 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 Humphrey FDT User Manual 2660021149532 A Operation ANR 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 ENTER PATIENT AGE 10 YEARS AGE 50 10 YEARS 1 YEAR ACCEPT SETTING 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
19. adverse reactions and safety hazards Type BF applied parts The Patient Forehead Rest and Patient Response button Alternating Current Power Off On Manufacturer E OEP Authorized European Community Representative m 8 Serial number e m mn Catalog number part number MODEL Model number European Conformity oN ZIN Disposal of the Product within the EU Do not dispose via domestic waste disposal system or communal waste disposal facility 154 Humphrey FDT User Manual 2660021149532 A Y 1 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 9096 non condensing 49C Keep Dry Temperature 20 to 49 deg C 20C 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 External Device Equipment A 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
20. als presented FIXATION ERRS 0 0 l FALSE POS ERRS 0 0 FIXATION ERRORS The ratio of the number of times the patient responded to a target FALSE NEG ERRS 0 0 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 Humphrey FDT User Manual 2660021149532 A 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 t
21. customer or user of the Humphrey FDT should assure that it is used in such an environment IEC 60601 Electromagnetic Environment Immunity Test Compliance Level Test Level Guidance ESD 6kV Contact 6kV Contact Floors should be wood concrete or ceramic IEC 61000 4 2 8kV Air 8kV Air tile If floors are synthetic material the relative humidity should be at least 3096 EFT 2kV Mains 2kV Mains ains power quality should be that of a typical IEC 61000 4 4 1kV 1 0 Not Applicable commercial or hospital environment Surge 1KV Differential 1KV Differential ains power quality should be that of a typical IEC 61000 4 5 2kV Common 2kV Common commercial or hospital environment Voltage Dips short gt 95 Dip in 0 5 gt 95 Dip in 0 5 ains power quality should be that of a typical interruptions and Cycle Cycle commercial or hospital environment If the voltage variations on user of the Humphrey FDT requires continued power supply input 60 Dip in 5 Cycles 60 Dip in 5 Cycles operation during power mains interruptions it lines is recommended that the Humphrey FDT be IEC 61000 4 11 30 Dip for 25 30 Dip for 25 powered from an uninterruptible power supply Cycles Cycles or battery gt 95 Dip in gt 95 Dip in 5 Seconds 5 Seconds Power Frequency 3 A m 3 Am Power frequency magnetic fields should be at 50 60Hz Magnetic Field IEC 61000 4 8 levels characteristic of a typical
22. ed 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 Carl Zeiss Meditec Inc Carl Zeiss Meditec AG 5160 Hacienda Drive Goeschwitzer Strasse 51 52 Dublin California 94568 07745 Jena Germany 1 800 341 6968 Phone 49 36 41 22 03 33 Fax 925 557 4101 Fax 49 36 41 22 01 12 Humphrey FDT User Manual 2660021149532 A Service Information Humphrey FDT User Manual 2660021149532 A Specifications IR 6 Specifications Instrument Dimensions 25 cm 10 wide x 48 cm 19 deep x 43 cm 17 high Weight Less than 9 kg 20 Ibs 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 Cto 35 C Humidity 10 to 90 non condensing Pressure
23. eleases 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 E LEFT EYE TEST MENU e RUN FULL THRESHOLD C 20 TEST Q 2 SKIP LEFT EYE GRN BUTTON CANCELS 24 JUN 1997 04 10 PM OVA Note To skip the left eye test select SKIP LEFT EYE Bottom Operator Button to proceed to the results menu Humphrey FDT User Manual 2660021149532 A 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 t
24. emes 3 1 UNDAGKING E E E E A 3 1 Preparation For Use and Power On 3 2 Pr paring fon a Patient Tests Ete Pe teen 3 6 Enter thiePatients Aqe iu e ete rede a e Ru Rs 3 7 Prepare the Patients coca cn teinte trente trate trente reete 3 7 Patent Reira Nony las 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 nennen eneen 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 nennen ennen eneen 3 20 Humphrey FDT User Manual 2660021149532 A 4 Calibration and Set up nn 4 1 Galibration and Setzup serment amants titt 4 1 A nn le E tices 4 1 Set up Instrument OPTIONS rca anand 4 2 Calibration ii a oe ted od 4 3 Software Upgrade a ici ta rede rece dere retainer it 4 4 MINO a eie io e dad 4 4 Printer Paper Replacement eseuen 4 4 FUSE Replace ME aida ERR 4 6 FDT Replacement Parts and Accessories 4 6 Cleaning Disinfection Sterilization and Disposal 4 7 CLEANING Et a e Bee pr eda quem e ten 4 7 DiSInfeCtlohr sete tege oce bt nec OR RR 4 7 St riliZatiOl c cic trt rt te ttg red a ate 4 7 Instrument DISDOSITIOTI c i ccn re ettet tenter rend 4 7 Troubleshooting iv
25. esponse 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 e Humphrey FDT Visual Field Instrument e Calibration Cap covering the Patient s Eyepiece inside the Patient Visor e Patient Response Button e Power Cord appropriate for local operating voltage e 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 before 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 Humphrey FDT User Manual 2660021149532 A Operation Paper Access Door Paper Access Door Finger Tab Finger Tab Preparation For Use and Power On Patient Side Serial N
26. he 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 The range of possible threshold level values for the raw 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 10g 49 2048 c 10 H where c ranges from 1 minimum contrast to 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 The device also provides MD amp 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 amp PSD values are directly correlated to the Humphrey Field Analyzer MD amp PSD indices The actual formulas used for the MD amp PSD indices calculations can be found in the references 2 3 The MD Mean Deviation index signifies overall severity of field lo
27. he 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 Humphrey FDT User Manual 2660021149532 A 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 PERCENT COMPLETE 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 OVA 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
28. hen 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 Humphrey FDT User Manual 2660021149532 A Calibration and Set up ES 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 ca
29. hen 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 FULL THRESHOLD C 20 C PRINT REPORT TEST DATE TIME 24 JUN 1997 04 05 pm PATIENT AGE 50 C ADVANCE PAPER RIGHT EYE TEST DURATION 03 40 VIEW RIGHT EYE LEFT EYE RESULTS TEST DURATION 04 17 e VIEW LEFT EYE RESULTS 24 JUN 1997 04 20 pm O OVA 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 on y until you begin a new test or until the instrument power is turned oft Using the RS 232 Serial Computer Interface O O The instrument includes an external serial RS 232 serial computer interface connector located on the bottom of the instrument This i
30. hould be one of the following Ophthalmologist or other Medical Doctor Optometrist or equivalent Humphrey FDT User Manual 2660021 149532 A Introduction 2 3 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 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
31. in increased emissions or decreased immunity of the equipment M 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 Humphrey FDT User Manual 2660021149532 A 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 Group 1 The Humphrey FDT uses RF energy only for its internal function Therefore its CISPR 11 RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions Class B The Humphrey FDT are suitable for use in all establishments including CISPR 11 domestic and those directly connected to the public low voltage power sup ply network that supplies buildings used for domestic purposes Harmonics Class A IEC 61000 3 2 Flicker Complies 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
32. ing 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 FREQUENCY DOUBLING TECHNOLOGY MAIN RUN PATIENT TESTS RUN DEMONSTRATION ADVANCE PAPER UTILITIES MENU OVA 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 D
33. isposed 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 e 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 e 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 Ope
34. l 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 User Manual 2660021 149532 A Operation Screening C 20 Test Result Sample SCREENING C 20 NAME AGE 67 ID 30 JUN 1997 03 02 pm RIGHT EYE Test duration 00 43 min Deviation 30 V e FIXATION ERRS 0 3 FALSE POS ERRS 0 3 LEFT EYE Test duration 00 40 min Deviation 30 FIXATION ERRS 0 3 FALSE POS ERRS 0 3 WITHIN NORMAL LIMITS MILD RELATIVE LOSS B MODERATE RELATIVE LOSS SEVERE LOSS Humphrey FDT User Manual 2660021149532 A Operation EXT Threshold C 20 Test Results Sample FULL THRESHOLD C 20 LEFT EYE NAME Test duration 04 13 min AGE 55 ID 01 JUL 1997 12 13 am Threshold dB 34 30 33 31 RIGHT EYE Test duration 03 28 min 31 30 31 33 29 Threshold dB 30 33 3 29 32 29 28 28 34 35 31 31 32 35 31 30 Deviation 32 31 35 35 30 30 31 31 34 N 35b wu e Deviation x ca MD 0 88 dB E PSD 42 97 dB FIXATION ERRS 0 6
35. libration 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 E UTILITIES MENU C SET UP INSTRUMENT MENU e RUN SELF CALIBRATION INSTRUMENT TESTS MENU C ABOUT FREQUENCY DOUBLING TECHNOLOGY 24 JUN 1997 04 01 pm OVA 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 t
36. lity is less than 5 P lt 5 that a normal subject of the same age eee 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 lt 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 OOOO D The probability is less than 1 P lt 1 that a normal subject of the same age mmAmAmAmAm Amm would perform at the threshold level that this patient achieved for the test ME Ra Huy RR CC locations with this shading E The probability is less than 0 5 P lt 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 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 tri
37. nity 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 N CAUTION In case of an emergency disconnect the appliance coupler Humphrey FDT User Manual 2660021149532 A Safety Information ENS 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
38. nterface 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 Humphrey FDT User Manual 2660021149532 A Operation FRE 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 first or second opportunity when tested at the contrast level that 99 P gt 1 of normal subjects of the same age would respond to for the test location with this shading LARA ALARMA AA MER CR C CR y B MILD RELATIVE LOSS The patient a ed to respond positively when tested at the 1 age normative contrast level P 1 after being given 2 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 A MODERATE RELATIVE LOSS The patient failed to respond
39. nual 2660021149532 A 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 e Nurse e Certified Medical Technician Ophthalmic Photographer e 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 s
40. o complete the calibration Humphrey FDT User Manual 2660021149532 A 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 Humphrey FDT User Manual 2660021149532 A Calibration and Set up PERS 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 be
41. o 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 Humphrey FDT User Manual 2660021149532 A 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 e 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
42. o 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 Humphrey FDT User Manual 2660021149532 A Introduction 25 Instrument Components Patient Side Forehead Rest Patient Visor Calibration Cap Patient Eyepiece Power Cord Voltage Selector Indicator Power Switch Patient Response Button Power Cord Inlet Operator Control Panel Operator Buttons Operator LCD Blue Cancel Backup Button Green Operator LCD Display Contrast Adjustment Buttons Printer Paper Paper Access Door Finger Tab Paper Access Door Finger Tab Paper Access Door Paper Printout Slot Paper Release Lever Humphrey FDT User Manual 2660021149532 A 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 e Four BLUE Operator Buttons along the left side of the Operator LCD Display A GREEN Cancel Backup Button below the four BLUE Buttons e Two Operator LCD Display Contrast Adjustmen
43. positively after being given 3 opportunities to do so twice at the 1 age normative contrast level P 2 196 and a third time at the 0 596 age normative contrast level P 0 5 for the test location with this shading D SEVERE LOSS The patient a ed 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 ERRORS The ratio of the number of times the patient responded to a target FIXATION ERRS 0 3 vr i FALSE POS ERRS 0 3 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 unders
44. rator 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 Humphrey FDT User Manual 2660021149532 A Service Information LE 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 authoriz
45. reening N 30 1 NAME AGE 64 ID 04 MAR 2001 2 35pm RIGHT EYE Test Duration 01 12 min Deviation Fixation Errs 0 3 False Pos Errs 0 3 Screening N 30 5 NAME AGE 64 ID 04 Mar 2001 02 40 pm RIGHT EYE Test Duration 01 42 min Deviation Fixation Errs 0 3 False Pos Errs 0 3 Probability Symb ols a rs ols P gt 1 0 P lt 1 P lt 5 BAA P lt 0 5 P lt 2 EN NOT SEEN AT MAXIMUM P lt 1 Humphrey FDT User Manual 2660021149532 A Operation EXA Understanding the Threshold C 20 and N 30 Test Results 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 gt 5 of normal subjects of the same age achieved for the test locations with this shading B The probabi
46. shock the instrument must be plugged into an earthed ground outlet Do not remove or disable the ground pin Humphrey FDT User Manual 2660021149532 A gt gt gt gt 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 vici
47. ss 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 lt 5 P lt 2 P lt 1 or P lt 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 Humphrey FDT User Manual 2660021 149532 A Operation EXT When the PSD value is GREATER than that of 95 of normal FDT fields the percentile probability is given P lt 5 P lt 2 P lt 1 or P lt 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 Tyrrel
48. t 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 Humphrey FDT User Manual 2660021 149532 A Introduction 27 Patient Video Screen Patterns Humphrey FDT User Manual 2660021149532 A Introduction Humphrey FDT User Manual 2660021149532 A Operation EER 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 R
49. t 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 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 separa
50. tand 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 Humphrey FDT User Manual 2660021149532 A 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 lt 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 lt 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 Sc
51. te 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 Humphrey FDT User Manual 2660021149532 A Operation EX FREQUENCY DOUBLING TECHNOLOGY MAIN MENU RUN PATIENT TESTS RUN DEMONSTRATION ADVANCE PAPER UTILITIES MENU 24 JUN 1997 04 08 PM DVA 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 RIGHT EYE TEST MENU RUN THRESHOLD C 20 RUN THRESHOLD N 30 SKIP RIGHT EYE GRN BUTTON CANCELS 24 JUN 1997 03 55 PM AAA Note To skip t
52. ts 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 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 Equipment Protection against electrical shock Type BF Degree of protection against electric shock of applied part forehead rest and Patient Response button e 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
53. 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 Humphrey FDT User Manual 2660021149532 A Operation Power Switch Fuse Drawer Cover Make sure that the two fuses are inserted so that they are closest to the protruding metal flanges Selected Voltage 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 Humphrey FDT User Manual 2660021149532 A Operation EMI RN E gt AS s Power Switch Power Cord Inlet To turn the instrument ON switch the Power Switch 0 1 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 EE FREQUENCY DOUBLING TECHNOLOGY MAIN MENU RUN PATIENT TEST RUN DEMONSTRATION ADVANCE PAPER UTILITIES MENU 24 JUN 1997 04 08 PM OVA Increase Contrast
54. umber Tip 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 Humphrey FDT User Manual 2660021149532 A Operation FX 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 115V T400L 230V T400L 115V A IE 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

Humphrey FDT Model 710 User Manual

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