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Safety Information

Humphrey FDT User Manual

2660021149532 Rev. B  2015-11

1-2

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.

Содержание Humphrey FDT 710

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 53: ......

Страница 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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