Zeiss Humphrey FDT 710 User Manual Download Page 7

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Humphrey FDT User Manual

2660021149532 Rev. B 2015-11

Safety Information

1-3

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.

Alternating Current

O I

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.

Summary of Contents for Humphrey FDT 710

Page 1: ...Humphrey FDT Model 710 User Manual...

Page 2: ...rl 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 trad...

Page 3: ...nts Patient Side 2 5 Instrument Components Operator Side 2 5 Instrument Components 2 6 FDT Overview 2 6 Patient Video Screen Patterns 2 7 3 Operation 3 1 Unpacking 3 1 Preparation For Use and Power On...

Page 4: ...ssories 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 Assi...

Page 5: ...fter 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 printe...

Page 6: ...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 CAUT...

Page 7: ...tions may also describe potential serious adverse reactions and safety hazards Type BF applied parts The Patient Forehead Rest and Patient Response button Alternating Current O I Power Off On Manufact...

Page 8: ...cal 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...

Page 9: ...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...

Page 10: ...at it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance ESD IEC 61000 4 2 6kV Contact 8kV Air 6kV Contact 8kV Air Floors should be...

Page 11: ...3 Vrms 150 kHz to 80MHz outside ISM bands 3 V m 80 MHz to 2 5 GHz V1 3 Vrms E1 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the Humphrey FDT including...

Page 12: ...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 a...

Page 13: ...e 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...

Page 14: ...tation 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 Certifi...

Page 15: ...eld 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...

Page 16: ...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 ins...

Page 17: ...Response Button Calibration Cap Forehead Rest Patient Visor Patient Eyepiece Power Cord Voltage Selector Indicator Paper Printout Slot Paper Access Door Finger Tab Printer Paper Operator LCD Operator...

Page 18: ...urther 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 Vis...

Page 19: ...Humphrey FDT User Manual 2660021149532 Rev B 2015 11 Introduction 2 7 Patient Video Screen Patterns...

Page 20: ...Introduction Humphrey FDT User Manual 2660021149532 Rev B 2015 11 2 8...

Page 21: ...ht 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...

Page 22: ...DT 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 patie...

Page 23: ...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 pr...

Page 24: ...er Cord into the Power Cord Inlet on the operator s right hand side and plug the opposite end into a standard power outlet Power Switch Fuse Carrier Voltage Selector Fuse Drawer Cover Selected Voltage...

Page 25: ...N 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 dec...

Page 26: ...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...

Page 27: ...ient 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 forehea...

Page 28: ...ng 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...

Page 29: ...REENING 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...

Page 30: ...l 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 shou...

Page 31: ...sed 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...

Page 32: ...ou can print as many copies as you d like 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 r...

Page 33: ...aintaining 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...

Page 34: ...nsitivity 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 t...

Page 35: ...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...

Page 36: ...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 d...

Page 37: ...ted with Threshold test results Refer to the Primer for Frequency Doubling Technology for information on Pattern Deviation plots 1 Tyrrell RA Owens DA A New Technique to Rapidly Assess the Resting Sta...

Page 38: ...Operation Humphrey FDT User Manual 2660021149532 Rev B 2015 11 3 18 Screening C 20 Test Result Sample...

Page 39: ...Humphrey FDT User Manual 2660021149532 Rev B 2015 11 Operation 3 19 Threshold C 20 Test Results Sample...

Page 40: ...Operation Humphrey FDT User Manual 2660021149532 Rev B 2015 11 3 20 Threshold N 30 Test Results Sample...

Page 41: ...ve 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 M...

Page 42: ...on 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 cha...

Page 43: ...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...

Page 44: ...t 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 p...

Page 45: ...e 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 pap...

Page 46: ...es the software on CD a serial cable and instructions DESCRIPTION PART NUMBER FDT Printer Paper box of 5 2660021101300 FDT Dust Cover 0000001096628 FDT Calibration Cap 0000001034279 FDT ViewFinder Sof...

Page 47: ...trument Damage to internal components may occur 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...

Page 48: ...strument 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 s...

Page 49: ...s 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 instrume...

Page 50: ...Service Information Humphrey FDT User Manual 2660021149532 Rev B 2015 11 5 2...

Page 51: ...rature 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 S...

Page 52: ...ld 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...

Page 53: ......

Page 54: ...25 557 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 me...

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