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GDxPRO - Amedeolucente.it

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1. c cceee 4 2 SCANMING PrOCCG WG asde 4 3 ESOO EX GUN aaa A A ha aces elenadon 4 3 SOE crt ncedaeteteatescmiceced hn sctdtcatcay A E seta 4 3 eSingle Exam Scan Workflow New and Existing Patient 00 4 4 Step ly POSIMOMING THE Patien csr easel a ee eects 4 5 aStei 2s Selecting PANEN FINALION secazct stzeszeenouvensanuguenesnareanusaaaneaseeeaant 4 6 s Stena DET Or UNINC MG FOCUS i uik seriastrtsc lar realtes arta E 4 7 Step A Acounng ihe Mage ssni 4 8 e Checking Image QuAIItYy ce eeece cece eeeeseeeeeeseseeeteeeeeeeeeeeaees 4 13 SQU Parame O 2c e N EA 4 13 e Checking the Corneal Measurement c sccsesssssssssesstsersssseserees 4 14 e Modifying the Macula Ellipse after Corneal Measurement 4 15 Checking the RNFL Measurement c seccssserssssssersseerserseersen 4 17 e Modifying the Macular Ellipse after RNFL I Measurement 0008 4 17 s Moding the ONH EIIDSC ssion 4 18 e Resizing the Calculation Circle c ciarecbeaduuenativedtsasedbenssbeusdnwibsedurertieed 4 21 SVU ENC Nens Imig tesse a O 4 23 sREtaKNO MEM G eena a RR ieee Gard 4 23 e Remeasuring the Corneal Compensation IMaQ cesceeeeees 4 24 Final Step Saving the SCANS ceccceeeseeeceeteeseeeeeeseeeneeeeeeeeees 4 25 s Acquiring Triple SCANS aicun 4 27 eTriple Scan Workflow New and Existing Patient 4 28 Managing Measurements 5 1 e Chapter Overview ssssssssssssrssrssrssresrssrssrsrnsrnsrnssnnrnr
2. Figure D 4 Disk Full Format Option A full format requires 18 29 minutes Figure D 5 Drag to Disc Disc Preparation Needed This disc requires preparation that will take approximately 16 to 29 minutes Do vou want to prepare this disc for use Drag to Disc Drag to Disc The dise in drive E i being prepared This will take 18 to 29 minutes Please wat Time Elapsed 0 Minutes 57 Seconds Figure D 5 Full Format Disc Preparation GDxPRO User Manual Data Transfer Using Optical Disks DME If the CD RW or DVD RW was previously formatted you can perform a quick Figure D 6 or full format Drag to Disc Format Options Volume Label Export 1 Enable compression on this disc Format Types for Rewritable Discs f Quick Format Allows you to begin using the disc quickly C Full Format Format the entire disc before using it Help Cancel Figure D 6 Disk Quick Format Option ga gt Note Both quick and full formatting effectively erase any data currently on the disk Use these options with care to prevent loss of patient data The Advantage of Full Format Full format has this advantage the disk ejects immediately after writing when you eject it If the disk is quick formatted it requires 15 seconds to 4 minutes for the disk to eject after writing to it depending on the amount of data written Rewriteable Disk Use Restrictions GDxPRO will not write export data to a CD RW or DVD RW disk that alr
3. GDxPRO User Manual Setup EM Confirm that the system is unlocked see Unlocking the System above Make sure the power cord is plugged in The power on off switch is located on the underside of the unit by the power cord inlet Power up the system by flipping the switch to the on position I on O off If the power switch is already on press the amber power button on the LCD to power up the instrument Note It is recommended to leave the system running during daily use and to power down at the end of each day At power up GDxPRO will run a warm up test procedure The test usually takes several minutes If the unit is cold e g if the unit was transported trom another office allow it to acclimate to normal room temperature before turning on the power It may take up to 30 minutes for GDxPRO to warm up and pass the system test As the test is being performed there will be a screen indicated that the test is in progress If there are no errors the system will start up normally Once the GDxPRO MAIN screen is displayed the system is ready for operation Powering Down the Instrument Whenever the system will be left idle for more than 6 8 hours it is recommended to turn off the power To do so first turn off the external printer if connected at the printer s power switch You can safely power down the GDxPRO through hardware or software as described below CAUTION You must power down the operating system safely Not d
4. Image quality score of six or lower Fundus images that were blurred too dark or saturated Optic nerve head position that was too low or too high resulting in the edge of the image extending beyond the largest measurement circle Large eye motion during image acquisition resulting in measurement area loss of greater than six percent Presence of floaters in all measurement circles Presence of peripapillary atrophy in all measurement circles Compensation residual gt 12 Note however than no ECC scans showed a compensation residual gt 4 e Typical Scan Score TSS lt 40 ECC In practice clinicians and operators should quantitatively and qualitatively review scans for quality Quantitatively a scan with a image quality score lt 7 a TSS lt 40 or a compensation residual gt 4 should be cautiously evaluated GDxPRO User Manual RNFEL Normative Databases and NFI ECC RNFL Normative Database Development The ECC RNFL normative database was developed utilizing the 251 normal subjects aged 18 82 from the study Co ection of Normative and Glaucoma Data Using GDx VCC Scanning Laser Polarimetry This normative database has an even gender distribution 128 females vs 123 males Ethnicity breakdown of the ECC normative database is as follows 42 Caucasians 36 Asians 14 Hispanics 6 African Americans 2 Indians Note that ECC normative data is not stratified by race the percentile values provided for comparison
5. Note The NFI cannot be used alone to classify patients into normal and glaucoma categories This parameter cannot replace clinical judgement and is intended to be used in conjunction with the multiple clinical tools considered the standard of care for glaucoma diagnosis This device is not intended to be used as the sole basis for diagnosis of eye disease The NFI was developed and validated without using patients who were considered glaucoma suspects but only eyes with a clear cut diagnosis of normal or glaucoma Thus its utility in eyes diagnosed as glaucoma suspects remains to be established However repeated studies have shown the NFI is the best single GDx parameter in differentiating between normal and glaucomatous eyes Because ECC and VCC have separate normative databases their NFIs were trained on different data sets Data analysis of the normal subjects used in the ECC and VCC NFI training reveals the following e 95 of the normal population shows ECC NFI values lt 35 and VCC NFI values lt 30 e 99 of the normal population shows ECC NFI values lt 55 and VCC NFI values lt 37 Please see A RNFL Normative Databases and NFI for additional information on the NFI GDxPRO User Manual Symmetry Analysis Symmetry Analysis Examples Following the framework in How to Read the Symmetry Analysis Report on page 6 4 we can analyze the following Symmetry Analysis examples Example data is
6. GPA Guided Progression Analysis The tracking of statistical significant change over time in parameters associated with glaucoma GDxPRO User Manual Glossary E import Process of copying exams from another location i e Network drive to the hard drive typically used to transfer exams between GDx instruments Infrared Infrared IR radiation is electromagnetic radiation of a wavelength longer than that of visible light but shorter than that of microwaves The name means below red from the Latin infra below red being the color of visible light with the longest wavelength Intrared radiation has wavelengths between about 750 nm and 1 mm spanning five orders of magnitude JPEG A commonly used method of compression for photographic images The compression method is usually lossy compression meaning that some visual quality is lost in the process and cannot be restored Image files that employ JPEG compression are commonly called JPEG files and the most common filename extensions are jog and jpeg The name JPEG stands for Joint Photographic Experts Group the name of the committee that created the standard LAN A local area network LAN is a computer network covering a small geographic area like a home office or group of buildings LCD Liquid Crystal Display An LCD is a thin flat display device made up of any number of color or monochrome pixels arrayed in front of a light source or reflect
7. To delete a measurement from the MEASUREMENTS List window select the More button on the MEASUREMENT List screen to see the Delete button Figure 5 4 Measurement List Full A GPA Progression Analysis report can be generated by selecting three to eight visits of the SAME type and selecting Print Export Review Operator dsanini Patient Joseph Steffani Patient ID 443434 Device 0143FBD70700003A Doctor Clinic Dr Jones Hacienda Clinic P 5 28 2002 11 29 AM 5 28 2002 11 33 AM YCC B2 Dr Jones 5 28 2002 11 37 AM VCC Ref Dr Jones 5 28 2003 11 11 AM VCC Dr Jones 5 28 2003 11 19AM YCC Dr Jones 5 28 2003 11 23 AM YCC Dr Jones 11 17 2003 11 42 VCC Dr Jones 11 17 2003 11 48 VCC Dr Jones 21 17 2003 11 51 YOC Dr Jones Mean Measurements Cancel Set Baseline Set Reference Exclude Select the Delete button to delete the selected measurement s Figure 5 4 Measurement List Screen Additional Buttons Select the measurement s you want to delete and then select the Delete button A Confirm Delete dialog will be displayed Figure 5 5 Contirm Delete 3 4re you sure you want to delete all of the selected measurements cancel Figure 5 5 Confirm Delete Dialog Select OK to delete the measurement s or Cancel to cancel the deletion e Multiple measurements selected for a given patient can be deleted at a time e Reference measurements cannot be deleted You must first deselect a mea
8. Introduction Safety Product Safety This instrument complies with the following standards e IEC 60601 1 e UL 60601 1 e CSA C22 2 No 601 1 M90 This instrument is classified as follows e Class Equipment Protection against electrical shock e Type B Degree of protection against electric shock of applied part chin and forehead rests e Ordinary Equipment IPX0 Degree of protection against ingress of liquids none e Continuous Operation Mode of operation WARNING To prevent electric shock the instrument must be plugged into an earthed ground outlet Do not remove or disable the ground pin Only an authorized Carl Zeiss Meditec service representative may install the instrument WARNING Do not use the printer or the instrument or the optional power table with an extension cord or a power strip multiple portable socket outlet For additional safety do not plug the printer and the instrument or the optional power table into the same wall outlet Failure to observe this warning could result in electrical shock to the patient and or examiner WARNING Do not open the instrument covers Opening the instrument covers could expose you to electrical and optical hazards WARNING To maintain patient safety an isolation transformer is required when connecting externally powered peripheral devices i e printer USB drive etc within 1 5 meters 4 9 feet from the patient In addition an isolation transfor
9. Reference Images Baselines and Excluded Measurements page 7 5 Overview of the GPA Report page 7 8 How to Read the GPA Report page 7 9 Report Contents page 7 10 GPA Examples page 7 16 Introduction to GPA Because glaucoma causes a slow loss of retinal nerve fiber layers identifying this loss and its rate can help diagnose glaucoma early assess which patients are at risk of reduced quality of life trom glaucoma and help measure treatment effectiveness Guided Progression Analysis GPA compares measurements over time and determines if the differences are statistically significant GDxPRO GPA reports Possible progression when a Significant change is detected and Likely progression when a significant change is contirmed Possible progression requires a minimum of three visits and Likely progression requires a minimum of four Note The GDxPRO GPA algorithms are designed to have 95 specificity for Likely progression Not all changes flagged by the software are true changes there could be false positives GPA recognizes when data has been acquired on different instruments or if the instrument s calibration was changed during a repair It can analyze data from two instruments but it requires two measurements from each GPA will automatically include inter instrument variability in the total test retest variability when analyzing data trom multiple instruments While specificity is not affected by the inte
10. Show the Eject dialog before ejecting a disc W This allows you to change the eject settings for the diec being ejected Advanced Eject Settings File Type Handling Administrator Settings Tum on compression x ee Sn show me again OF Cancel Help Figure D 7 CD R and DVD R Drag to Disc Eject Options GDxPRO User Manual Maintenance E14 2 E Maintenance Chapter Overview Carl Zeiss Meditec designed the GDxPRO to require very little user maintenance Most maintenance activities covered here are required only occasionally except for routine cleaning between patients This chapter covers the following topics e Replacing Fuses page E 1 e Removing Hard Disk Drives page E 4 e Transporting page E 9 e Handling Error Messages page E 11 e Hard Disk Defragmentation page E 11 e Routine Cleaning amp Disinfecting page E 12 e Replacing the Face Mask page E 13 e List of User Replacement Accessories page E 18 Note Regarding Warranty Note Except for the main power fuses the GDxPRO has no user replaceable parts The user must not attempt hardware repairs except fuse replacement without consulting Carl Zeiss Meditec service personnel To do so voids the instrument warranty However we may provide software updates that users can install Replacing Fuses Both the instrument and the optional power table have two fuses Instructions to check and replace the fuses in both the instrument and table are incl
11. eD Cole cO iets nahc bho ania ses tentaundbens tae teaantivendeaeack A 3 ECC RNFL Normative Database Development cccccccccsecseceeeeee A 4 SECC NEI DEVelIO OMEN ceea an ec aeataataake A 8 COM CNIS ON arae a a Giada stele Witla tate tees deuetderse use ban A 11 VCC Normative Database and NFI sesser A 12 Selection and Testing Of Subjects cccceccssetestssessseesesseeeeeten A 12 Data Collecion and REVICW ies eo 85io fico a dave can eaaa A 14 YCC RNF Normative Databasessa A 14 SN FIIDOV CIO BIN GIN enasna arne a a A 15 Network Storage Device Configuration B 1 PTTL OC UICL OE ne SA B 1 e NAS Device Safety Warnings cscscsscsssssssssssssrssssersesesersseeeers B 1 e NAS Device Requirements ccccecssseecssteeesssessseessseeeseseeeeeseenss B 2 e NAS Device RecommendationS ccccccccseeeessseeeessseeeesseeeeesseeeeens B 2 e Installing and Configuring the NAS DeVICE ccscecsseeseseeeees B 3 Cleaning the NAS Device ccccscssssstessecsrsssessessrssessessreseeenes B 5 GDxPRO User Manual C D E F G H 1 Printer Configuration ssssssssssssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnna C 1 IMEFOCUCHION stexinciaetaacescnsscen wraldteseeiemiareiaemincineu eter thcenteanaaent C 1 Approved Printers ieocistossccusihadniinetdasacchettadecstenutiaasnanviaetwlsdondaeee C 1 Printer Safety WarningS cccccesesecscsscsesesesseseessesseesseiteaeseeees C 2
12. 1 connected to the GDxPRO using an Unshielded Twisted Pair UTP network cable CZMI recommends using a least a CAT 5 UTP network cable 2 plugged into a different power outlet than the GDxPRO and 3 qualified by CZM for use with the GDx Failure to observe this warning could result in electrical shock to the patient and or examiner GDxPRO User Manual Introduction 9 WARNING To directly connect a printer to the GDxPRO only use a UTP network cable Use of a shielded network cable will ground the printer through the GDxPRO which could result in electrical shock to the patient and or examiner It could also invalidate the system safety approval WARNING Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards e g IEC 60950 for data processing equipment and IEC 60601 1 for medical equipment Furthermore all configurations shall comply with the system Standard IEC 60601 1 1 Any person who connects additional equipment to the signal input part or signal output part configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of the system standard IEC 60601 1 1 If in doubt consult the technical service department or your local representative External Monitor You can connect an external monitor to the DVI I Video port of the GDxPRO instrument e g for presentations larger monitor The DVI I video car
13. Color coded Eye Icons 7 11 2007 12 54 VCC Jay Lawrence 7 11 2007 12 56 VCC Jay Lawrence S 7 11 2007 12 57 VCC Jay Lawrence 7 11 2007 13 01 VCC Jay Lawrence 7 11 2007 13 01 VCC Jay Lawrence 7 11 2007 13 03 VCC Jay Lawrence 7 11 2007 13 03 VCC Jay Lawrence 7 11 2007 13 05 VCC Jay Lawrence vane 7 11 2007 13 06 VCC Jay Lawrence Comment Select Mean Image List i to view only mean measurements previous hares alee ae ES Select Print amp Export Options to print or export Select Review for on screen review Figure 5 1 Measurements List Full Screen The Mode column identifies the image type and whether the image is a baseline image see Setting Baselines on page 7 6 reference image see Setting the Reference Image for Automatic Image Alignment on page 7 5 or mean image see Creating a Mean Measurement Manually on page 5 8 The Exam Doctor column displays the Exam doctor tor the measurement displayed either selected during exam acquisition or mean generation The Exam doctor can be different from the Pymary doctor associated with the patient and defined on the PATIENT INFORMATION screen Figure 3 7 A GDx Device identifier is displayed below the operator name to identify the device on which the selected measurement was acquired Column width can be resized by dragging the borders between columns with your mouse Your changes are saved with the software GDxPRO User Manual Managing Measure
14. License Windows XP License Location 1 12 List of User Replacement Accessories E 18 Log File Event 8 13 Export Error Log 8 12 Log Off 2 3 Low Vision Target 4 6 M Macula Ellipse Moditying 4 15 4 17 Placement 4 16 Proper Positioning 4 16 Main Screen 3 1 Manual F1 Function Key 1 4 Organization 1 3 PDF 1 4 Manual Refraction 4 8 Manual Selection of Measurements 5 5 Mean Image List 5 4 Mean Measurement 4 31 5 8 Measurement Acquisition 4 10 Measurement List Screen 5 1 Additional Buttons 7 5 Index Measurements Deleting 5 7 Excluding trom Auto Selection 7 7 Viewing Mean Images 5 4 Merging Databases 8 4 Merging Patients 3 10 Modity ONH Ellipse 4 18 4 22 Moditying the Macula Ellipse 4 15 4 17 Monitor Connecting External Monitor 1 9 More Button on the Measurement List Screen 7 5 N NAS Device B 1 Installation and Configuration B 3 Navigation in General 1 4 Nerve Fiber Indicator 6 11 Nerve Fiber Indicator NFI 6 11 Nerve Fiber Layer 1 1 Nerve Fiber Layer Map 6 7 Network Storage Device Configuration B 1 New Patient 3 1 NFI Nerve Fiber Indicator 6 11 Normative Databases 4 11 O On Screen Exam Review 5 5 On Screen Report Review 7 4 ONH Ellipse Moditying the Position 4 18 Placement 4 14 Operating System Resources 8 23 Operator Add Modify 2 8 Comments 5 5 Delete 2 8 Information 2 9 Set Up 2 7 Operator Console 1 5 Operator Information Screen 2 9 2 11 Operator List Screen 2 8 Optics Lockdown Screw Hole 1 6 O
15. M identifies which three measurements are used to create the mean Test Retest Variability STD At upper right the screen reports the standard deviation STD of the scans using a plain language description number and background color as follows e Variability OK STD lt 8 5 Green e Variability Marginal 8 5 lt STD lt 11 5 Yellow e Variability Too High STD gt 11 5 Red GDxPRO User Manual Selected Reference Image with asterisk Select Reference button Managing Measurements If there is no reference image for the eye when creating a mean a reference image will be automatically created trom the selected images with the highest Quality Score The REVIEW MEAN screen will display a Select Reference button and will have an asterisk to the right of the M for the reference image Figure 5 9 You can use the Select Image button to navigate to or select another image and then use the Select Reference button to change the reference image to that image Review Mean OD Q 9 1 30 2007 o M Q9 1 90 2007 Cancel E Eza Add Exam select Image Selen Remowe Exam Accept Reference Figure 5 9 Review Mean Screen with Selected Reference Image To add an exam to your exam choices for creating the mean select the Add Exam button to display a list of possible exams to add Figure 5 10 r amp Note When creating a mean during a Triple Scan the Add Exam button will display an ACQUISITION screen to take another exam ra
16. Use the Left Right Up and Down positional buttons one click moves one pixel Shift click moves 5 pixels to adjust the macular ellipse position A dot in the center of the ellipse makes it easier to center the ellipse Figure 4 13 There is no need to change the size of the macular ellipse If the macula bow tie is not well defined press the Irregular Pattern button When Irregular Pattern is selected the software uses an alternative corneal calculation based on the macula area within a dotted square which does not require macular ellipse placement and the position buttons are not available Figure 4 14 Modify Macula Ellipse Measuring Cornea Right OD Dotted Square Indicates Optimal ONH Centering aera na ir ONH located inside cone 930 ai dotted square indicates accurate patient fixation Cancel Macular ellipse centered on macula bow tie pattern Irregular Macula Ellipse Pattern size Figure 4 12 Modify Ellipse Measuring Cornea Screen after Corneal Scan GDxPRO User Manual Scanning Procedures Eye with low Eye with moderate Eye with high corneal birefringence corneal birefringence corneal birefringence Macular bow tie pattern well defined Macular bow tie pattern well defined Macular bow tie pattern well defined macular ellipse well centered macular ellipse well centered macular ellipse well centered Figure 4 13 Proper Positioning of Macula Ellipse Modify
17. according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the higher frequency applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people GDxPRO User Manual E gt i gt m 5 m E lel PATENT S O g m m Introduction Symbols and Labels Caution consult accompanying documents Note There are important operating and maintenance instructions found in the manual Presence of electrical shock hazard Note Indicates risk of electrical shock due to the presence of uninsulated high voltage inside the instrument Do not remove the instrument cover or parts Fuse Type B applied parts Manufacturer Authorized European Community Representative Serial number Catalog number part number European Conformity Model Patent GDxPRO User Manual Introduction 1 21 Protective Packing Symbols The protective packing symbols specify the handling requirements and the transport and storage conditions Handling Requirements Fragile Handle with Care Keep Dry This end up Transport and Storage Conditions Relative Humidity 10 to 75 non condensing 10 75 NON CONDENSING 60C Temperature 20 to 60 deg C Atmospheric Pressure Limits 500 hPa to 1060 hPa 20C 500 hPa to 1060 hPa GDxPRO User Manual Introduction Product Labels and
18. and expressed in units of Polarimetric Micrometers P um Physician Interpretation Physician Signature GDxPRO c afl Za s Meditec n All rights reserved Software Version 1 0 Figure 6 9 Example 1 Severe OD RNFL Loss GDxPRO User Manual Symmetry Analysis Example 2 Physiological Cupping This report Figure 6 10 on page 6 15 can be evaluated as follows 1 Verify data quality For OD the TSS is lower than the recommended limit Ideally the scan would be repeated in an attempt to improve it especially if the scan will be part of a baseline for GPA However the image may still cautiously be used because there is little visible artifact 2 Assess Nerve Fiber Layer Maps and Symmetry between Eyes Both Nerve Fiber Layer Maps display yellow and red patterns which are more pronounced inferiorly This pattern is indicative of a normal RNFL The Inter Eye Symmetry parameter is within normal limits The TSNIT Graph is also within normal limits and highlights split bundles in both the superior and inferior areas though these are more obvious superiorly 3 Evaluate and Compare Deviation Maps Neither Deviation Map has any colored squares meaning all areas of both RNFLs are within normal limits 4 Evaluate the NFI and other RNFL I Summary Parameters The NFI in each eye is 12 and no parameters are outside normal limits This is consistent with what is displayed in the graphic elements 5 Apply Symmetry results in context o
19. described in G Glossary the RNFL I measurement is the phase shift that occurs when polarized light passes through the RNFL A measurement capability unique to GDx RNFL I is derived from both RNFL thickness and RNFL structural organization This mechanism is distinctly different trom other retinal imaging devices that quantity axonal loss by measuring RNFL thickness directly Specifically SLP captures birefringence a tissue property that depends on the integrity of retinal ganglion cell axon microtubules and neurofilaments 4 SLP thus has the capacity not only to corroborate findings of RNFL thinning as determined by other methods but may also provide insight into structural damage due to changes in density and orientation of the RNFL microstructures that may precede or occur in the absence of RNFL thinning A comparison of retinal imaging techniques can yield complementary information on RNFL abnormalities Note The output of previous generation GDx instruments was reported as micrometers um This unit was renamed to polarimetric micrometers P um in the GDxPRO P um reported in the GDxPRO is the same as micrometers um reported in the GDxVCC Note RNFL I expressed as P ym is distinct from thickness measured by other devices and expressed as ym Like the RNEL the anterior segment the cornea and lens is also birefringent However the GDxPRO isolates anterior segment birefringence and compensates for it
20. installation OV rVIOW cccccsessessesseesessesseesseessressreseeseeseeeaes C2 e Network Configuration ssssssssssesssssnersseersrrrnrrennrsrnrnnnsrnennnnrnsrernnas C 3 e1 Connect the Hardware seein ictiet cavesctact avian den sdtentduions race ladestonrsiedea C3 e2 Configure the Printer for Network Use C4 USB CONMNGQUIAU O Marna C 4 Data Transfer Using Optical DisKs 000ssse D 1 SOV CIM OW rengiasi D 1 e Compatible Media Formats cccccsccsesscsssssesessessessesereseesees D 1 e Compatible Data Transfer FUNCTIONS cccccesccseeecssssrseeserseeeeees D 1 e Data Transfer INStructiONnS cccccccsceeeeecsesseserseessesesetenerseeees D 1 PRON ANIC DIS Cunuana etm csena loeuctaugaalictiadeebnamunceeei D 2 Proper DISK CANO sents sacar cheaiad aaa N a a D 2 DISK Formatting sasir tteetnnpetenssborss sestatdacentapeesieennt D 3 e Roxio Drag to Disc Software Configuration cccccccssseseeeees D 5 Maintenance cce E 1 e Chapter Overview scszats cosscictcant ccanesaresals basnabstseaeecascainsyeetttiadeeaasaneniteh E 1 REDIACING FUSES uaaa a O O E 1 e Removing Hard Disk Drives ssssseseseseneseesssrerrererrernrrnrnnnnrrnenennnne E 4 shans pOrINO cce a eanseeipeas meee ne E 9 e Handling Error MeSSaQ S ccccceseceeeeeeceeeeeeseeeeeseeeieeeeeneeeeetaes E 11 e Hard Disk Defragmentation ssssssesseeeenesesrersenersrnernrsrnensrernseereee E 11 e Routine Cleaning amp Disinfecti
21. or excessive eye motion report TSS lt 40 ECC e Image contains significant artifact e If using VCC switch to ECC TSS lt 60 VCC e Interpret with caution Residual gt 4 in ECC or e Significant error in corneal compensation e Repeat RNFL scan if it has suspected flaws Otherwise gt 12 in VCC Symmetry repeat both the corneal and RNFL scans Analysis report Consider switching from VCC to ECC or vice versa GDxPRO User Manual Troubleshooting Table F 1 Image Troubleshooting Guide Issue Message Potential Cause s Recommended Action s Dark band s on edge s Eye movement during scan acquisition e Image may be used if no interference with Calculation of scan Circle Blood vessels appear e Eye movement during scan acquisition e Repeat the RNFL scan blurred GDxPRO User Manual Glossary oa G Glossary Anterior Segment Front third of the eyeball from the surface of the cornea to the start of the vitreous humor As used in this document this is used to refer to those anatomical features that are optically transmissive including the cornea and the lens The birefringence of these structures is dominated by the birefringence of the cornea Archive 1 The process of moving exam images to another computer or 2 the physical media or volume on the computer used to store the images Used for freeing hard drive space and backing up Automatic Image Alignment Retinal blood vessels are
22. the first progression map under Exam 3 is generated by comparing Exam 3 to the baseline images The areas of significant change when first detected are displayed in yellow for Possible progression The next progression map is generated by comparing Exam 4 the current exam to the baseline images and significant change is found in some of the same areas as the previous exam Since this significant change has been seen two consecutive times the areas of change are displayed in red for Likely progression Notice that there are also some yellow areas in the last progression map showing changes not seen in the previous exam GDxPRO User Manual Guided Progression Analysis GPA Ua For each exam displayed on the top row the following is displayed below the exam acquisition date Typical Scan Score TSS TSS provides a measure of the typicality of the RNFL image For more information see Typical Scan Score TSS on page 6 6 Image Quality Score Q For more information refer to Quality Parameters on page 4 13 If Q is below 7 an exclamation icon will be displayed next to the Q value If the image has an alignment problem an alignment icon will be displayed Single is displayed for single measurements The standard deviation SD is displayed if the image is a mean of two or three measurements If the exam is part of a baseline set it is indicated by displaying Old Baseline for the previous bas
23. trained on known normal and glaucomatous eyes and essentially uses pattern recognition to discriminate between these The NFI is an ordinal number that is related to likelihood that the polarimetric retinal nerve fiber layer map is abnormal A high number is more likely to be related to abnormality but is not definitive The NFI is not intended to be used as the sole basis of diagnosis for disease Normative Database A database of SLP imaging results collected under controlled conditions from normal patients of varying age and ancestry The database is structured to allow a patient s results to be compared with normal patients of similar age and ancestry Optic Nerve Head ONH An area of the retina where the optic nerve attaches to the fundus and connects to the retinal nerve fiber layer RNFL This is roughly oval in shape Blood vessels also enter the eye through the ONH also known as the Optic Disc PC Personal Computer A PC may be a home computer or may be found in an office often connected to a local area network The distinguishing characteristics are that the computer is primarily used interactively by one person at a time A PC is the physical part of a computer including the digital circuitry as distinguished trom the computer sottware that executes within the hardware For the purposes of this manual a PC only runs a Microsoft Windows operating system GDxPRO User Manual Glossary A Portable Document Format
24. 127 For 100 120 V and 220 240 V Systems 2660021121819 Cable Ethernet CAT5e 14 2660021116418 Cable USB MA MB 6 2660100057507 Roxio Software on Disk 2660021121363 Face Mask 2660021128537 User Documentation CD To order In the U S call 800 341 6968 Outside the U S contact your local Carl Zeiss Meditec distributor GDxPRO User Manual Troubleshooting iam CF Troubleshooting If you are unable to resolve a problem with your GDxPRO please contact CZM customer service In the U S call 800 341 6968 outside the U S contact your local CZM distributor GDxPRO Will Not Start Up e Make sure the GDxPRO power cord is properly connected to the power outlet e Check for a broken power fuse e Check if a USB flash drive is inserted in a USB port The GDxPRO may not boot if a USB flash drive is inserted in a USB port GDxPRO Locks Up e Write down any error message received including all numbers and codes e Write down the steps that were taken to produce the problem e Power down and then power up the GDxPRO see Powering Down the Instrument on page 2 3 and Powering Up the Instrument on page 2 2 Keyboard or Mouse Does Not Work e Make sure the keyboard mouse is properly connected e Disconnect and reconnect the keyboard mouse while system is powered up e Cycle power External Color Printer Does Not Work e Make sure the printer is properly connected getting power and is turned on e Cycle power e Check owner s ma
25. 17 2006 11 6 Update Measurement 0008 OS GDX_ACCESS THICKNESS 8 17 2006 11 7 21 2005 11 05 33 AM 6 12 2006 8 41 54 AM 6 12 2006 8 45 02 AM 6 12 2006 8 47 02 AM 6 2 2006 11 12 52 am 10 40 21 AM 11 28 19 AM 11 31 45 AM 5 15 2002 6 18 2003 6 18 2003 57197 2004 9 5 19 2004 9 5719 2004 9 13 16 19 ei ouu a l Peay 200k L Pflf2 005 LE 6 2 2006 11 ee 6 2 2006 11 23 31 56 28 744 7 38 aes 54 746 26 oo 04 OF 746 19 STZ OF 40 39 53 58 08 SE 53 50 JA 30 AM dsanini AM dsanini dsanini dsanini dsanini dsanini dsanini dsanini dsanini dsanini dsanini dsanini AM AM AM AM AM AM dsanini dsanini dsanini dsanini dsanini dsanini dsanini dsanini dsanini dsanini dsanini dsanini Figure 8 20 Example Event Log File in Notepad GDxPRO User Manual System Functions System Diagnostics System diagnostic tests verity that your system is operating correctly As a part of the tests the software will verify that the calibration is consistent over time Some system test measurements are classified as critical Failure of these critical tests will cause image acquisition to be disabled Figure 8 21 System Diagnostics Application Space Remaining 10 5 GB Primary Storage Space Remaining 94 8 GB secondary Storage Space Remaining 111 1 GB Polygon Lifetime Galvo Lifetime system Tempera
26. 1768 pm 1861 pm ONH Ellipse Circle Medium Circle Large Figure 4 23 Fundus Image and Nerve Fiber Layer Map 2 Circle Small is the default setting You can select Circle Medium or Circle Large to resize the Calculation Circle beyond the PPA or affected area in the image The button for the currently selected circle size is deactivated Figure 4 24 shows examples of small medium and large Calculation Circles 3 You can see the results superimposed on the image and visually determine whether or not the calculation circle is positioned optimally Small calculation circle Medium calculation circle Large calculation circle intersecting PPA area intersecting PPA area avoiding PPA area Figure 4 24 Examples of Small Medium and Large Calculation Circles GDxPRO User Manual Scanning Procedures 9x3 ga Note When performing a GPA analysis the software overlays the circle size from the reference image onto each subsequent image to calculate change If it becomes necessary to resize the calculation circle for previously imaged patients you must also resize the calculation circle on the reference scans prior to performing a GPA analysis Viewing the Iris Image Select OD Iris Image or OS Iris Image to see the right and left iris image respectively with alignment overlays Figure 4 25 The iris image allows you to see if the scan has been properly aligned When the Q score is low or when variation is high you can use the Iris
27. 2 A gt Iris Image Check _ _ _ Retake Image gt Iris Image Check gt Retake Image Scan 3 OD OS Review Triple Scans 3 OD OS Review Triple Scans 3 me gt Iris Image Check weneneeensnene Retake Image a Iris Image Check SS SSS Retake Image OD OSs OD Os Review Save gt Review Save Review Save Review Save Mean Mean Mean Mean Review _ Preview OD OS Preview lt OD OS 7 Print is aban OD OS Vee m Print F OD OS reenen List xport 4 Review Results poberi Export lt Review Results Screen Not available if reference image has been set Figure 4 30 Triple Scan Workflow New and Existing Patient GDxPRO User Manual Scanning Procedures IEE Follow these steps to acquire a Triple Scan 1 On the PATIENT INFORMATION screen select Triple Scan Figure 4 29 If this is a new patient you must first perform corneal compensation scan s as out lined in Scanning Procedure starting on page 4 3 When corneal compensation scan s are complete for a new patient or when refraction settings have been con firmed for an existing patient the first Triple Scan ACQUISITION screen is displayed Fig ure 4 31 Acquisition ECC Triple Scan 1 Current scan mode Triple Scan ECC Mode Refraction Auto Age Range 40 49 Ancestry Eastern Cancel Reset Restart Low Vision Figure 4 31 Acquisition Screen fo
28. 2 Examine GPA printout e Summary box The Image Progression Map has a red check mark e The Image Progression Map shows focal inferior loss The TSNIT Progression Graph does show a dip in the Inferior quadrant corresponding to this wedge but it was not flagged because the change was too narrow to affect 4 adjacent segments 3 Apply GPA results in context of patient Determine if the changes indicated by GPA are clinically significant The patient is over 70 and developed inferior loss over just two years which is confirmed by the photos below Figure 7 14 Here are the fundus images for this case June 2004 June 2006 Figure 7 14 Defect on Progression Image Map also Visible on Fundus Images GDxPRO User Manual Guided Progression Analysis GPA AA Name ID Exam Date Q6 19 2006 Imported DOB 11 16 1936 Exam Time 14 10 Gender Male Operator zkunczyn Ancestry Black Physician Imported n a IM Fast Mode GDxPRO Guided Progression Analysis GPA arate Gomeat compensation vcc ODright Image Progression Map TSNIT Progression Graph RNFL I Summary maze o T S N l T A Y Image Progression Map Ar TSNIT Progression Graph Summary Parameter Charts A Seek clinical correlates Saiak P um O RNFL I Summary Parameter Charts P um GDx changed TSNIT x Average 5 50 C fi C rPIAnr 100 Perr w Sample courtesy of Average i Robert M Weinreb MD a Felipe A Medeiros M
29. 30 2007 11 21 AM Jones 1 30 2007 11 22 AM Cancel Create Mean button Comment lDr John Gutierrez Create Mean Review Mean Set Baseline Set Reference Delete Exclude Figure 5 6 Create Mean If one of the selected measurements was acquired more than thirty days of another selected measurement an error dialog Figure 5 7 will be displayed and the mean image will not be created Mean Measurement 1956 mean image can only be created with measurements that are acquired within one month of each other The mean image could not be created Figure 5 7 Create Mean Error dialog GDxPRO User Manual Managing Measurements Sa Mean measurements cannot be used to create a mean and a single measurement already used in a mean cannot be used to create another mean As a general rule a mean can only be created with measurements from the same GDxPRO instrument and or calibration The reference image and baseline images can be part of a mean After selecting the Create Mean button the Review MEAN screen is displayed Figure 5 8 Review Mean VCC Q Image Quality Score oD Right Eye M identifies the measurements used in mean creation Selected exam with red border Add Exam select Image Remove Exam Accept Figure 5 8 Review Mean Screen If more than three measurements are present the best three based on lowest variability or STD will be automatically selected for the mean Q represents the Image Quality Score
30. 7 15 Ancestry Screen 3 3 Anti Virus Software 1 13 Approved Software 1 13 Attending Doctor 2 6 Auto Selection of Measurements 5 4 Excluding 7 7 AutoFocus Scan 4 1 4 7 Automated Report Generation 5 1 6 5 Automatic Image Alignment 7 5 B Backup Database 8 9 Baseline Indicator on Progression Analysis Report 7 15 Baselines Resetting 7 14 Setting 7 6 Beep Sound 4 10 Birefringence 4 3 Blue Asterisk on RNFL I Summary Parameter Charts 7 14 Buttons Selecting 1 4 C Calculation Circle 4 21 4 22 6 5 6 8 6 10 7 12 Calibrating Instrument 7 1 Touch Screen 2 4 Calibration Change 7 14 Canthus Mark 1 6 4 5 Care in Handling 1 10 GDxPRO User Manual CE Mark 1 13 CFB Change From Baseline 7 3 Check Fuses E 2 Table Fuses E 1 Cleaning E 12 Comment Field 4 25 5 5 5 12 Component Test 8 22 Computer Specifications H 3 Confidence Interval 7 13 Connecting Devices 1 7 1 8 Connectors 1 7 1 8 Contraindications 1 2 Copyright Software 1 3 Cornea 4 1 Corneal Birefringence 4 16 Corneal Compensation Resetting 4 24 7 7 Corneal Measurement 5 3 Image Check 4 14 Modifying Ellipse 4 16 Resetting 4 24 7 7 Corneal Scan 4 1 Create Association Screen 2 10 CZM Options 8 25 D Data Export 8 7 Import 8 7 Data Storage 1 8 Database Backup 8 9 Merging 8 4 Optimize 8 3 Recalculate Data 8 5 Restore 8 9 Set Database 8 8 Database Options Screen 8 12 Date Setup 2 5 Decrypt Event Log 8 13 Defragmenting Hard Drive E 11 Deleting
31. Cornea Cornea refers to an image acquired without corneal compensation Analysis of the macular region of this image allows the corneal polarization magnitude and axis to be measured Cornea is a corneal measurement exam performed at the patient s first visit The results in the macular region of this exam are analyzed to determine the optimum settings for the variable corneal compensator used to cancel out the effect of the birefringence of the cornea for subsequent ECC and VCC exams Corneal compensation A method to compensate for corneal anterior segment birefringence of an eye Necessary to isolate RNFL birefringence and determine accurate RNFL I measurements CPU Central Processing Unit Also called processor a component of computer hardware where software instructions are processed and executed The CPU performs most of the calculations which enable a computer to function sometimes referred to as the brain of the computer CZM Carl Zeiss Meditec Database A complete record of all patient and exam information in the instrument On the GDxPRO instrument the database is stored on the instrument s hard disks In Review Software the database is stored on the Server computer DVI Digital Visual Interface DVI is a video interface standard designed to maximize the visual quality of digital display devices such as flat panel LCD computer displays and digital projectors DVI I stands for DVI Integrated and sup
32. Documents a F My Computer See OSC Hs Data iD Es DATAZ Es H TOUGHDRIVE Fi ey DYDICO RW Drive Gr Set Local Disk 4 4 Shared Documents E Zeiss s Documents i My Network Places Figure 8 11 Full Backup Browse for Folder Dialog GDxPRO User Manual System Functions After you select the folder select OK to perform the full database backup Select Cancel to cancel the backup Restore The database can be restored trom the full backup replacing the existing system database WARNING The restore operation will replace all data on the master drive Once started there is no way to recover the data to the previous state Select the Restore button to restore a database that you have backed up with the Full Backup function A Browse for Folder dialog Figure 8 12 will be displayed where you can select the folder where the database has been backed up Browse for Folder Enter the Database Folder See Daka Ds See DATAZ Es TOUGHDRIVE Fs DYDICD RvY Drive as See Local Disk 41 H Shared Documents H Zeiss s Documents My Network Places Cancel Figure 8 12 Restore Browse for Folder Dialog Atter you select the folder select OK to perform the database restore Select Cancel to cancel the restore If you select OK a warning message will be displayed Figure 8 13 Warning WARNING The current database and associated images will be deleted during the restore process and re
33. Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the GDxPRO including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 174P d 1 17 P 80 MHz to 800 MHz Conducted RF 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz son d 2 33 P 800 MHz to 2 5 GHz Radiated RF 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electro
34. Figure 8 24 Additional information is indicated by the lightly shaded portion s of the horizontal scroll bar below the list of errors You can cancel the test by pressing the Esc or Cancel button If the test is cancelled before the end of a full test sequence the system may take up to a minute before testing actually stops ga Note Never power down the instrument during a System Test GDxPRO User Manual System Functions Component Test Selecting the System gt System Diagnostics gt Component Test button will display the EXERCISE HARDWARE screen Figure 8 27 which contains instrument hardware component tests For assistance call Carl Zeiss Meditec customer service In the U S call 800 341 6968 Outside the U S contact your local CZM distributor Exercise Hardware Firmware Memory Tests Frame Grabber OPTCON oMMCON Memory Memory Memory stepper Motor Tests Tatie Focus Position pomnea Modulator Position Compensator Aquisition Hardware Tests OK Polygon Cancel Fan Tests Top Fan Off side Fan On Figure 8 27 Exercise Hardware Screen GDxPRO User Manual System Functions FE Operating System Resources Selecting the System gt System Diagnostics gt Operating System Resources button will open the Windows Control Panel folder Figure 8 28 amp Control Panel File Edit View Favorites Tools Help a O Back i O Search Wey Folders EBk Address J amp Name Comments 4 vg Contro
35. Image function to rule out alignment issues Iris Image Cancel Figure 4 25 OS Iris Image Screen Retaking the Image ga Note Once image quality of an image has been accepted it cannot be retaken Upon completion of a scan you can choose to retake an image if the quality is not satisfactory GDxPRO User Manual Scanning Procedures At the IMAGE CHECK screen select Retake Image to display the IMAGE RETAKE SELECTION screen Figure 4 26 You can choose Retake Both Eyes or OK Retake Right OD Eye or Retake Left OS Eye Image Retake Selection Retaking an image overwrites the previous image from this session Press the appropriate retake button to continue or the Cancel Go Back button to return to the Image Check screen Ee EI Retake Both Retake Right Retake Left Eyes OD Eye 05 Eye Figure 4 26 Image Retake Selection Screen After you make your selection the system returns to the previous ACQUISITION screen to obtain the selected new scan s The system will only overwrite the image or images that you retake For example if you only retake the image of the right eye the previous image of the left eye is retained without being overwritten and the right image is replaced When satisfied with the information on the IMAGE CHECK screen select Accept or OK to go to the REVIEW CALCULATIONS screen Figure 4 27 Remeasuring the Corneal Compensation Image During an exam the system may alert you to reset c
36. MEASUREMENT LIST SCREEN See Selecting Measurements on page 5 1 you may print and or export the measurements Select Print amp Export Options to display the PRINT AND EXPORT OPTIONS screen Figure 5 3 Print and Export Options Cancel FI Export Raw a Export Report Data Print Setting Figure 5 3 Print and Export Options Screen Print will print one copy of the generated report s to the current default printer Export Report will export the generated report s to the default export path see Default Import Export Path optional on page 2 10 Select Yes to use the default export folder or select No to display a Browse for Folder dialog where you can select the export folder you want to use Export Raw Data will export the selected measurement s raw data to the default export path see Default Import Export Path optional on page 2 10 Select Yes to use the default export folder or select No to display a Browse for Folder dialog where you can select the export folder you want to use The raw data includes the measurement data calculations patient data and images not formatted into reports This allows you to analyze the data on another GDxPRO store the data in an external drive etc Print Setting will open the GDxPRO s PRINTERS AND FAXES window where you can see your printers view and change printer settings and set the default printer GDxPRO User Manual Managing Measurements AA Deleting Measurements
37. Print amp Export Options button see Printing Exporting Exams on page 5 6 Selecting Measurements At the PATIENT INFORMATION screen see Patient Information Screen on page 3 8 for a selected patient select Review to display the MEASUREMENT LIST screen Figure 5 1 The MEASUREMENT LIST screen allows you to select one or more measurements images or exams for the selected patient For a Symmetry Analysis report select one right OD and one left eye OS of the same image type For a Progression Analysis report GPA select three to eight measurements of the same eye and image type You may select OD and OS measurements simultaneously The software automatically selects measurements to generate a report based on the type and number of measurements in the MEASUREMENT LIST screen see Auto Selection on page 5 4 GDxPRO User Manual Managing Measurements The list of measurements is sorted by Exam Date acquisition time old to new You can review these on screen print reports export or delete GDx Device Identifier Column width can be Measurement List Full changed by dragging 4 GPA Progression Analysis report can be generated by selecting three to eight visits of borders with mouse the SAME type and selecting Print Export Review Operator mwarning Patient Joe Baker Patient ID 91876 Device 014444190A000079 Primary Doctor Clinic Dr Jay Lawrence Lawrence Clinic i Date Mode Exam Doctor
38. Single Single Most sensitive to diffuse change If a significant Rate of Change has been detected it is Baseline WaT Baseline a ire displayed ai N Nerve Fiber Layer Maps Sequence of up to 8 nerve fiber layer maps Physician Interpretation Physician Signature GDxPRO Possible increase is often due to ass measurement variability and is therefore displayed with a warning to check data quality Sample courtesy of Robert M Weinreb MD Felipe A Medeiros MD PhD Hamilton Glaucoma Center University of California San Diego Figure 7 7 Sample Guided Progression Analysis GPA Report Right Eye OD GDxPRO User Manual Guided Progression Analysis GPA a How to Read the GPA Report 1 Verify data quality Cy Verity image quality If there were any quality issues a flag A or is displayed below the Image Progression Map Discard or retake images with poor registration Q lt 7 or TSS ECC lt 40 or TSS VCC lt 60 whenever possible or interpret with caution For example see the Nerve Fiber Layer Maps below S 04 06 2004 09 5 04 11 2006 09 05 04 03 2007 08 45 100 i 100 100 Single Single Single Baseline In the Nerve Fiber Layer Maps above Visit 2 was taken with a dilated eye which may have caused registration issues You should delete it How similar are the baselines Examine the TSNIT Graph RNFL Summary Parameter Charts and Ne
39. Single Single Single Baseline Baseline Nerve Fiber Layer Map 0 70 140 P um Progression Map Physician Interpretation Physician Signature GDxPRO Figure 7 16 Example 2 Inferior Change Identified by All Approaches GDxPRO User Manual Guided Progression Analysis GPA Example 3 Dual Baseline Analysis Simulated Data This report Figure 7 17 on page 7 21 can be evaluated as follows 1 Verify data quality e The Quality Scores of all images are 10 and the TSS scores are 100 There are no registration errors e The baselines look highly consistent Visits 1 and 2 are the first set of baselines Visits 3 and 4 are the second set of baselines e The analysis was done using Extended Mode for greater sensitivity Standard Deviation SD values for the mean images are below 8 6 2 Examine GPA printout e Summary box Likely Progression was found on both the TSNIT Progression Graph and the RNFL Summary Parameter Charts applies to Visits 3 6 e All detected RNFL loss was in the interior bundle The trend for the Interior Average seen for Visits 1 4 was 3 9 1 1 P um year The trend for the Interior Average seen between Visits 3 6 was 1 8 1 1 P um year 3 Apply GPA results in context of patient The dual baseline analysis implies the rate of RNFL loss decreased since Visit 3 presumably as the effect of intervention Combine this information with other clinical observations
40. Statistical Image Mapping 7 3 Single Exam 4 3 ECC or VCC 4 1 Workflow 4 4 Slope 7 13 Software and Storage Media 1 8 Software Copyright 1 3 Software License Agreement 1 3 Sound Moditying 4 10 Specifications H 1 CE Mark 1 13 Computer H 3 Electrical Requirements H 3 Environmental Conditions H 3 Specificity 7 1 Spectacle Refraction 4 8 Standard Deviation SD Displayed on Symmetry Analysis Report 6 6 Standard Deviation STD 5 9 Displayed on Progression Analysis Report 7 15 Standard Target 4 6 Summary Box 7 2 7 10 Summary Parameters Table 6 10 Superior Average 6 10 7 13 Symbols and Labels Defined 1 20 Symmetry Analysis Report 6 2 Examples 6 12 How to Read 6 4 Overview 6 3 System Diagnostics 8 16 GDxPRO User Manual System Tests Automatic System Test 8 16 User Initiated Tests 8 17 Continuous Test 8 19 System Test 8 17 T Test Retest Variability Box 5 9 TFT Flat Panel 1 4 TIFF 2 16 Time and Date Setup 2 5 Tips to Avoid Damage 1 10 Touch Screen 1 4 1 5 Calibration 2 4 Using 2 4 Transport and Storage Conditions 1 21 Transporting E 9 Shut Down for Transport Function 2 4 E 9 Triple Scan 4 3 5 8 ECC or VCC 4 1 Standard Deviation 5 9 Workflow 4 28 Troubleshooting Power Problems E 1 TSNIT Average 6 10 7 13 TSNIT Graph 6 8 TSNIT Progression Graph 7 10 7 12 TSNIT Standard Deviation 6 10 TSS 6 6 7 15 Turning Off 2 3 Turning On 2 2 Typical Scan Score TSS 6 6 7 15 U Unlocking the System 2 2 USB Flash Drives 1
41. System Functions Printer Setup The Printer Setup function System gt Printer Setup is described in the Setup chapter See Setting Up a Printer on page 2 15 Set Time amp Date The Set Time amp Date function System gt Set Time amp Date is described in the Setup chapter See Setting the Time and Date on page 2 5 Software Update You may receive optical disks from CZM that update the System software for the GDxPRO To update the System software select System gt Software Update to display the SOFTWARE UPDATE screen Software Update This operation will update the GDx Software Insert the Software Update CD DVD labeled GDx Software Upgrade into the DVD Drive and Select OK to continue with update or Press Cancel to cancel operation and return to previous screen Cancel a Waiting for user response Figure 8 2 Software Update Screen Insert the optical disk labeled GDxPRO Software Upgrade into the optical drive and select OK to continue with the update Follow the on screen prompts Select Cancel to cancel the update and return to the MAIN screen GDxPRO User Manual System Functions am Database Options The DATABASE OPTIONS screen System gt Database Figure 8 3 allows the user to optimize database performance and merge exam files from another GDx A Full Backup and Restore database function is also available Database Options Optimize As databases are used their perform
42. The GDxPRO is intended for use in the electromagnetic environment specified below The customer or user of the GDxPRO should assure that it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance The GDxPRO uses RF energy only for its RF emissions Group 1 internal function Therefore its RF CISPR 11 emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B CISPR 11 The GDxPRO is suitable for use in all a establishments including domestic Harmonic emissions Complies i establishments and those directly IEC 61000 3 2 connected to the public low voltage Voltage fluctuations Complies power supply network that supplies flicker emissions buildings used for domestic purposes IEC 61000 3 3 Guidance and manufacturer s declaration electromagnetic immunity The GDxPRO is intended for use in the electromagnetic environment specified below The customer or user of the GDxPRO should assure that it is used in such an environment Immunity Test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic Discharge 6 kV contact 6 kV contact Floors should be wood concrete or ceramic ESD IEC 61000 4 2 8 kV air 8 kV air tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for power supply 2 kV for power supply Mains pow
43. Triple Scan acquisition facilitates the creation of means of three measurements used in Extended Mode GPA analysis GDxPRO User Manual Scanning Procedures Adding New Patient or Selecting Existing Patient To scan a new patient with no previous exams stored in the database you must first create a new patient record At the MAIN screen select New Patient To perform an exam on a patient whose data is already stored in the system you must locate and highlight the patient record in the database At the MAIN screen select Existing Patient Please refer to 3 Managing Patient Records for instructions on adding a new patient or searching for an existing patient When the patient of interest is highlighted either on the PATIENTS List screen or on the SEARCH FOR PATIENT screen press OK and you will see the PATIENT INFORMATION screen Figure 4 1 To begin the scan procedure see Scanning Procedure on page 4 3 Patient Information Name Gan lone Patient ID fue Date Of Birth ee March 20 1965 Ancestry jen jes Cancel Primary Doctor Clinic ie Oppenheimer Hacienda Clinic Gender single Exam Triple Scan Rewiew Delete I Figure 4 1 Single Exam Button on Patient Information Screen GDxPRO User Manual Scanning Procedures ay Scanning Procedure IMPORTANT The GDxPRO quantitatively measures the RNFL by first measuring the value of corneal birefringence contribution for each eye im
44. caution due to small sample size It should also be noted that this normative database does not have any subjects younger than 18 years old Selection and Testing of Subjects All individuals in the database normal and glaucoma patients had complete ophthalmic exams Specitically data was captured from Medical history reviews Refraction and Visual Acuity exams Biomicroscopy exams IOP exams Standard Automated Perimetry exams Humphrey 24 2 SITA standard program Ophthalmoscopy exams GDx VCC exams Inclusion and Exclusion Criteria Inclusion Criteria for Normal Subjects e Males or females 18 years of age or older e Best corrected visual acuity of 20 40 or better in each eye Exclusion Criteria for Normal Subjects e Presence of glaucoma or history of ocular hypertension in either eye e Intraocular pressure of 22 mm Hg or greater in either eye e A visual field test showing one or more of the following e An unreliable visual field test result gt 25 false positive or false negative responses or gt 15 fixation losses e Mean Deviation MD or Pattern Standard Deviation PSD of p lt 5 or worse e Glaucoma Hemitield Test GHT result of Borderline or Outside Normal Limits e Optic discs that demonstrate hemorrhage notching peripapillary atrophy extending into the area of analysis rim thinning exudation local RNFL injury and or asymmetry between the eyes of more than 0 2 C D ratio e Concomitant active
45. create a Windows user account A Windows User ACCOUNTS screen will be displayed Figure 2 9 User Accounts Learn About User Accounts B User accounts 2 User account types 2 Switching users Pick a task Change an account Create a new account Change the way users log on or off or pick an account to change dsanini jchin Computer administrator Computer administrator Password protected ped Password protected jgutierr tnguyen Computer administrator Computer administrator Password protected Password protected Guest es Guest account is off Figure 2 9 User Accounts Screen GDxPRO User Manual Setup Enter the following fields as described below e Operator Enter a name for the operator this can be any name e Domain Enter the computer or domain name or select a domain from the drop down menu e User Enter a valid Windows User Account name from this GDxPRO e Default Import Export Path optional Enter the default path to a folder you want to import from and or export to for this GDxPRO This folder is also used for the auto export functions at the end of exam acquisition see Setting the Preview Export Image Type on page 2 16 Note Only one operator can have the same Domain and User name Note Each operator may have a different network default destination for exported imported data The currently selected operator determines the default network destination that will be used if you pe
46. data is acquired for the TSNIT Temporal Superior Nasal Inferior Temporal and NFI parameters By default the Calculation Circle is set to the smallest size It can be resized if necessary in order to obtain more meaningful results for patients with significant parapapillary atrophy PPA and scleral crescent see Figure 4 24 Calculation Circle area between these two circles Figure 4 21 Calculation Circle Use the following procedure to modify the size of the Calculation Circle in order to obtain higher quality measurement data for patients with PPA and scleral crescent See Figure 4 24 Image Check ECC OD RightEye Diameter Left Eye Diameter ff f2008 1024 Sif f2008 Y 2233 H 1024 H 1117 PPA Score Cancel Alignment Fixation Refraction Other Retake Image Modity OD Modify 0S OD Iris Image Momy n Macula OS Iris Image Modity oa Macula ONH Ellipse ONH Ellipse Ellipse Ellipse Figure 4 22 Calculation Circle with Parapapillary Atrophy PPA GDxPRO User Manual Scanning Procedures 1 From the IMAGE CHECK screen select Modify ONH Ellipse for the desired eye The MODIFY CALCULATION CIRCLE AND ONH ELLIPSE screen appears as shown In Figure 4 18 Select Calculation Circle The MODIFY CALCULATION CIRCLE AND ONH ELLIPSE screen appears as shown in Figure 4 23 Modify Calculation Circle and ONH Ellipse Right OD Ellipse Diameter Horizontal H Yertical Y
47. discretion of the user You can attach the NAS device directly to the GDxPRO Ethernet port or you can connect it via your office network local area network or LAN These instructions cover both scenarios Once installed and correctly configured for use with the GDxPRO the NAS device serves the same functions as a network server and the instructions for using a network server apply to the use of the NAS device WARNING We strongly recommend you use peripheral devices supplied or approved by Carl Zeiss Meditec when available because they will have been tested to work with the instrument If you do use a peripheral device that conforms with the requirements in this section but is not supplied by Carl Zeiss Meditec do not install any unapproved third party software on the instrument Installation of any unapproved software including drivers could degrade the performance of the instrument and or lead to corrupted diagnostic or therapeutic information and may void the instrument warranty If you wish to use a third party peripheral device seek technical support trom the device manufacturer Repairs necessitated by the attempt to use a non approved peripheral device are not covered under warranty NAS Device Safety Warnings WARNING To directly connect the NAS device to the GDxPRO use an Unshielded Twisted Pair UTP network cable CZMI recommends using a least a CAT 5 UTP network cable Use of a shielded network cable will ground the NA
48. e Entering a New Patient page 3 1 e Selecting an Existing Patient page 3 5 e Patient Information Screen page 3 8 e Editing Deleting Patient Records page 3 8 e Exporting and Importing Patient s Data page 3 9 e Merging Patients page 3 10 Entering a New Patient To scan a new patient with no previous exams stored in the database you must first create a new patient record At the MAIN screen Figure 3 1 select New Patient to display the PATIENT IDENTIFICATION Screen Figure 3 2 Cancel E Ea GDxPRO V 1 0 1 www meditec zeiss com GDxPRO 15 22 Tuesday December 09 2008 2008 Cari Zeiss Mediet Inc Al nghts reserved Existing set Up shut Down for Patient Operator Transport Figure 3 1 GDxPRO Main Screen GDxPRO User Manual Managing Patient Records Patient Identification Use Tab or ShifttTab to switch items Change months using the arrow keys Type the day and the year Change Doctor Clinic information using arrow keys Patient ID Last Name a First Name as Middle Name Optional Date of Birth Month Day Year January a 4 1950 4 Doctor Clinic Doctor Clinic Figure 3 2 Patient Identification Screen Enter a unique ID number e g medical record number EMR PMS identification number in the Patient ID field The Patient ID field is not case sensitive oa Note If an EMR PMS system will be used either now or in the fut
49. from damage during transportation See Transporting on page E 9 for more information Operating the Touch Screen Operation of the GDxPRO literally is at your fingertips You can perform all functions whether entering data or selecting a test simply by touching a button on the touch screen An audible beep sounds whenever you touch the screen Note While using the touch screen the button is activated when your finger is removed from the button you select Be careful not to pound or press too hard against the touch screen A light touch works best CAUTION Do not use any sharp objects ball point pens etc to operate the touch screen It can be easily scratched Calibrating the Touch Screen Note Touch Screen calibration is the only calibration done by the user All other GDxPRO calibration is done by Carl Zeiss Meditec To calibrate the Touch Screen select System gt System Diagnostics gt Calibrate Touch Screen to display the first calibration screen Figure 2 3 Touch the targets from a position of normal use Figure 2 3 Calibrate Touch Screen 1 GDxPRO User Manual Setup C With your finger touch the target in the upper lett Another target will be displayed on the lower right and then the upper right for you to touch After pressing these targets a screen will be displayed asking you to move your finger across the screen Figure 2 4 Touch the screen Does the cursor follow your finger Vv Figure 2
50. image and low Image Quality Score However the effect of lenticular opacification cataract on image quality has not been established Patients who are unable to fixate on a target with the subject eye These typically are patients with loss of central vision Patients with refractive errors outside the following ranges 8 D to 13 D Patients less than 18 years of age such patients can be imaged but they are not supported by the normative databases Carl Zeiss Meditec does not offer advice in the diagnostic interpretation of GDxPRO scans It is the clinician s responsibility to make diagnostic interpretations of GDxPRO scans GDxPRO Technology The GDxPRO employs patented GDx Scanning Laser Polarimetry SLP technology to provide quantitative information about the retinal nerve fiber layer RNFL A measuring beam passes through the RNFL until it is reflected back by the fundus As it goes through the retina and RNFL the beam is split into two components with a relative phase shift proportional to the RNFL thickness and structural organization of the RNFL microstructures illustrated in Figure 1 1 Retinal Nerve Fiber Polarized Light RNFL I Measurement RNFL Micro Structures Figure 1 1 RNFL Assessment with SLP GDxPRO User Manual Introduction 3 To differentiate GDx RNFL Polarimetric Thickness measurements from RNFL thickness measurements from other devices we introduce the term RNFL Integrity RNFL I As
51. import data records from the specified location into the database Report Export Image Types a cance Select these checkmarks to automatically export Report Auto Export Report After Exam and or Raw Data after exam acquisition to the default M Auto Export Raw Data After Exam export path Recalculate Optimize Data Export Data Import Data Set Database Backup Restore Figure 2 20 Database Options Screen Select the Report Export Image Types drop down menu to select the Preview Export image type The available image types are e PDF recommended e TIFF e JPEG To close the preview report and return to the GDxPRO application select the close box in the top right corner of the preview screen Press Alt Esc on the keyboard to toggle between the GDxPRO application and the preview screen Check the Auto Export Report After Exam checkbox to automatically export the exam s generated report to the default export path see Default Import Export Path optional on page 2 10 Check the Auto Export Raw Data After Exam checkbox to automatically export the exam s measurement raw data to the default export path see Default Import Export Path optional on page 2 10 Select OK to save your settings GDxPRO User Manual Managing Patient Records a 3 Managing Patient Records Chapter Overview This chapter describes how to access and manage patient records on the GDxPRO Topics covered in this chapter include
52. issued with an embedded Windows XP Pro operating system license located on the bottom of the instrument GDxPRO User Manual LA S6a97 A Introduction 113 Product Compliance Complies with 93 42 EEC Medical Device Directive Complies with US and Canadian medical electrical system safety requirements User Changes to Software or Hardware The GDxPRO is a medical device The software and hardware have been designed in accordance with U S European and other international medical device standards designed to protect clinicians users and patients from potential harm caused by mechanical diagnostic or therapeutic failures WARNING Unauthorized modification of GDxPRO software or hardware including peripherals can jeopardize the safety of operators and patients the performance of the instrument and the integrity of patient data it also voids the instrument warranty Approved Software including Anti Virus Please refer to the GDxPRO Home page www meditec zeiss com GDxPRO for a link to the current list of approved hardware and software Note Carl Zeiss Meditec does not provide technical support for the use of unapproved third party software WARNING It is possible that GDxPRO functionality may be adversely affected by the presence installation or use of third party software on the same computer The user and not Carl Zeiss Meditec assumes all risks associated with third party software GDxPRO User Manual A
53. ocular disease GDxPRO User Manual RNFL Normative Databases and NFI A 13 e Congenital ocular abnormalities e Previous intraocular surgery other than cataract e Previous retinal surgery e History of glaucoma among first degree relatives e History of diabetes leukemia AIDS uncontrolled systemic hypertension dementia or multiple sclerosis Inclusion Criteria for Glaucoma Subjects e Males or females 18 years of age or older e Glaucoma as evidenced by optic discs that demonstrate hemorrhage notching rim thinning exudation local RNFL injury observed change in C D from prior examination and or asymmetry between the eyes of more than 0 2 C D ratio assuming no difference in disc size e Best corrected visual acuity of 20 40 or better in each eye Exclusion Criteria for Glaucoma Subjects e Active ocular disease except glaucoma e Previous intraocular surgery except cataract e History of diabetes leukemia AIDS uncontrolled systemic hypertension arteriosclerosis dementia or multiple sclerosis Subjects were detined as Normal if they met the following criteria Best corrected visual acuity of 20 40 or better in both eyes IOP less or equal 21 mm Hg No history of ocular neurological or systemic diseases that might affect the visual field system Normal visual field indicated by a Glaucoma Hemitield Test within normal limits and MD and PSD gt 5 probability level Normal optic disc indicated by the following n
54. or systemic diseases that might affect the visual field system e Normal visual field indicated by a Glaucoma Hemitield Test within normal limits and MD and PSD gt 5 probability level Subjects were defined as Glaucoma Patients if they met the following criteria e Except for glaucoma no history of ocular neurological or systemic diseases that might affect the visual field system e Glaucomatous visual field defined as any two of the following e PSD significant at p lt 5 level e Abnormal Glaucoma Hemitield test result e A cluster of 3 or more non edge points in a location typical for glaucoma depressed at p lt 5 level and one of the points depressed at p lt 1 level Data Collection After undergoing a thorough ophthalmic examination 251 normal and 215 glaucoma subjects had scans of their retinas taken with the GDxVCC device using ECC and VCC scan protocols Both protocols were repeated three times to acquire the RNFL I measurements These three GDx ECC scans were averaged and that average was used in the development of the ECC normative database and the ECC NFI Therefore to be consistent with the development criteria it is recommended that three scans be obtained and averaged for valid utilization of the ECC normative database and the ECC NFI GDx Scan Selection Criteria The scans were reviewed for image quality and the scans having the following characteristics were excluded trom the normative database and NFI development
55. see Patient Information Screen on page 3 8 Figure 3 4 Gender Optional Screen Review the patient information If the information is not accurate select Edit on the PATIENT INFORMATION screen to change any or all of the information for this patient If you select Edit the PATIENT IDENTIFICATION ANCESTRY and GENDER screens will be displayed again for you to edit You will be asked to contirm the patient update changes Select OK to update the patient information GDxPRO User Manual Managing Patient Records tAE Selecting an Existing Patient This section describes how to select existing patient record s stored in the database Once a patient is selected the patient s information may be viewed and changed and exams for that patient can be selected for reviewing printing exporting and deleting as described in 5 Managing Measurements At the MAIN screen select Existing Patient to display the SEARCH FOR PATIENT screen Figure 3 5 Search for Patient search for a patient using the three edit controls As patients are found the remaining fields are automatically filled in Once the patient is found press the OF button Patient ID T Last Name _ First Name Middle Name Date Of Birth Ancestry Gender View Full List Figure 3 5 Search for Patient Screen You can search for patients in two ways e Do a direct patient search see Direct Patient Search on page 3 6 by entering the
56. so that only the RNFL is analyzed There are two types of corneal compensation Enhanced Corneal Compensation ECC and Variable Corneal Compensation VCC ECC is virtually always superior and is therefore the default VCC is provided for continuity with historical scans GDxPRO User Manual Carl Zeiss Meditec designed this User Manual to serve as a detailed usage and reference guide for the GDxPRO instrument The GDxPRO User Manual instructs you in the procedures for imaging the patient creating and managing patient records reviewing measurements and creating reports We assume that users are clinicians or technicians with professional training or experience in the use of ophthalmic imaging equipment and in diagnostic interpretation of the images generated Organization of the Manual This introductory chapter 1 provides a system description and safety information Chapter 2 covers setup information and usage Record management is discussed in chapter 3 Chapter 4 covers exam acquisition Measurement management is discussed in chapter 5 Reports are covered in chapters 6 and 7 Other chapters cover System Functions Data Transfer Using Optical Disks Maintenance Troubleshooting Specifications and Legal Notices GDxPRO User Manual Introduction See A RNFL Normative Databases and NFI for ECC and VCC normative databases and NFI development B Network Storage Device Configuration for NAS drive information and C Prin
57. strip multiple portable socket outlet For additional safety do not plug the printer and the instrument into the same wall outlet Failure to observe this warning could result in electrical shock to the patient and or examiner Installation Overview The following three general steps are common to all configurations These steps are explained further in the specific sections 1 Printer hardware setup and configuration Refer to the instructions provided with the printer to unpack and set up the printer hardware Printer configuration is typically not required 2 Connect hardware to enable communication between instrument and printer The hardware used depends on the type of configuration you select either a network cable or a USB cable 3 Configure the instrument software to communicate with the printer including installation of printer drivers if required If there are no driver installation instructions provided with the printer then driver installation is not required GDxPRO User Manual Printer Configuration am Network Configuration A network connection can be established either 1 directly between the GDxPRO and the printer or 2 by connecting both the GDxPRO and the printer to the local area network or to a network switch or hub connected to the GDxPRO Follow the general instructions below 1 Connect the Hardware For the direct connection between GDxPRO and printer use one UTP network cable to connect the networ
58. the instrument is powered through it Check the following to determine the source of the power problem in order 1 Is there power available everywhere in your office e If not there may be a localized power outage in your office or a general power outage in your neighborhood e Ifso proceed to step 2 2 Does the table have power while the instrument does not You can test the table by trying the lift e If the table has power the power problem is within the instrument First check that the instrument power cord is plugged in at the power table and at the instrument Next check the instrument fuses and replace them if necessary See Check and Replace Instrument Fuses on page E 2 for instructions e If the table does not have power the power problem is likely within the table First check that the table is plugged in at both the wall outlet and at the table Next check the table fuses and replace them if necessary See Replacing Fuses on page E 1 for instructions Check and Replace Instrument Fuses Two fuses are located on the bottom right side of the instrument just to the left of the power cord inlet CAUTION Carefully follow these instructions to safely check and replace fuses Always power down the instrument and unplug the power cord before proceeding At all times use the minimum force necessary to accomplish each step so as to prevent damage or injury 1 Before replacing the main fuse be sure that GDxPRO is powered
59. the previous and next command Pressing Select will update the Selected Doctor Clinic with the Doctor and Clinic highlighted in blue and the systems Doctor Name Clinic Name Hacienda Eye Clinic Dr Oppenheimer Your Best Eye Clinic Imported Imported Cancel EJ Previous Delete Modify Doctor Add Doctor Figure 2 13 Doctor List Screen Use the mouse to select a doctor blue background or select the Previous and Next buttons to move through the list until you select the doctor of interest You may also use the up and down arrow keys on the keyboard GDxPRO User Manual Setup HEN To modity a doctor select a doctor and then select the Modify Doctor button to display the DOCTOR INFORMATION screen Figure 2 14 Doctor Information Doctor Name Dr Oppenheimer Clinic Name Hacienda Clinic Address 6544 Hacienda Drive Dublin CA were Country Zip Code USA 94568 Telephone Number 925 555 0100 OK City State Figure 2 14 Doctor Information Screen To delete a doctor from the Doctor List screen Figure 2 13 select a doctor and then select the Delete button If the doctor is not associated with any patients a CONFIRM DELETE dialog will be displayed Figure 2 15 Contirm Delete Are vou sure you want to permanently delete the currently selected information cancel Figure 2 15 Doctor Confirm Delete Screen Select OK to delete the doctor Select Cancel to cancel the deletio
60. to determine if further changes should be made in the patient s treatment plan GDxPRO User Manual Guided Progression Analysis GPA 77 Name ID Exam Date 02 17 2006 Imported DOB 06 02 1974 Exam Time 10 50 Gender Male Operator mpintsberg Ancestry Asian Physician Imported GDxPRO Guided Progression Analysis GPA Variable Corneal compensation VCC TSNIT Progression Graph RNFL I Summary o 8 N E L Y Image Progression Map Nes i A Aa TSNIT Progression Graph i A Summary Parameter Charts Seek clinical correlates 20 r mA P um O RNFL I Summary Parameter Charts P um 100 TSNIT wt Rate of Change P um yr Average i 01 20 2001 2 0 0 6 p lt 0 1 80 70 60 50 BO EEE Se 30 100 Superior Average Inferior p Rate of Change P um yr Average 01 20 2001 3 9 141 p lt 0 1 G 04 15 2003 1 8 1 1 p 0 4 0 Baseline Reset Age 27 28 29 30 31 32 33 34 35 36 37 Exams 1 2 3 4 5 6 01 20 2001 11 29 10 02 2001 13 00 04 15 2003 08 42 02 14 2004 14 31 03 22 2005 08 20 02 17 2006 10 50 TSS 100 TSS 100 TSS 100 TSS 100 TSS 100 TSS 100 Q10 Q10 Q10 Q10 QQ Q10 SD 4 30 SD 4 31 SD 3 56 SD 4 29 SD 3 52 SD 4 34 Baseline Old Baseline Old Baseline Baseline Nerve Fiber Layer Map 0 70 140 P um Progression Map Physician Interpretation Physician Signature Figure 7 17 Example 3 Baseline Reset Displays Decreased Range of Progression B
61. used as landmarks to align all images for a given eye to a single reference image This step is required for mean image creation and progression analysis Once the images are aligned the ONH and macular ellipses from the reference image are copied to all other images Baseline exams The first two exams in a progression analysis A baseline set is two measurements of the same eye used for GPA Two baselines sets for a given eye refer to 4 individual measurements Two baseline sets are referred to as previous and current baseline exam sets Birefringence A property of optical materials in which the effective index of refraction encountered by an incident light beam varies depending upon polarization of the incident light Uniaxial birefringent materials have two indices of refraction The material has a fast axis associated with the smaller index and a perpendicular slow axis for the larger index An incident beam with a polarization direction parallel to the slow axis encounters the larger index of refraction and thus travels at a slower speed Many optical structures in the eye exhibit birefringence including the cornea the lens and the RNFL Button An object displayed on the computer screen that can be selected with the mouse and activated by clicking Computer GDxPRO instrument component that contains the central processing unit random access memory and disk drive GDxPRO User Manual Glossary
62. very typical Exams with TSS ECC lt 40 or TSS VCC lt 60 should be interpreted with caution the particular scan may not be reliable GDxPRO User Manual Glossary USB Universal Serial Bus USB is serial bus standard to interface devices USB was designed to allow peripherals to be connected using a single standardized interface socket and to improve plug and play capabilities by allowing devices to be connected and disconnected without rebooting the computer hot swapping USB is intended to help retire all legacy varieties of serial and parallel ports USB can connect computer peripherals such as mouse devices keyboards digital cameras printers personal media players and flash drives VCC Variable Corneal Compensation A VCC exam uses the results of the Corneal Scan to set the variable compensator and cancel the effect of the birefringence of the cornea VCC images can be acquired and reviewed on the GDxPRO GDxPRO User Manual Specifications A H Specifications Illumination Laser Source e GaAlAs laser diode 785 nm nominal value 776 nm 800 nm actual 3 mW instantaneous power and lt 1 mW average power at the cornea Fixation Laser Source e Laser diode 635 nm 15 nm 0 5 mW instantaneous power and lt 1 uW average power at the cornea Laser Classification e Class 1 Laser product Maximum Instantaneous Power at Cornea e 3 0 mW Measurement Area e 40 1 2 Horizontal x 20 0 6 Vertica
63. 0 35 40 4 50 amp GO 6 7 0 75 GO 835 100 NFI Incidence Figure A 9 NFI Distribution for Pre Perimetric Patients Incidence _ ho ao So oi Lo oO 0 5 6 11 16 21 26 31 36 41 46 51 56 61 66 71 76 81 86 91 96 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100 NFI Figure A 10 NFI Distribution for Glaucoma Patients with Visual Field Loss Validation of VCC NFI was performed using independent study data collected subsequently for the GDxVCC instrument titled Co ection of Normative and Glaucoma Data Using GDxVCC Scanning Laser Polarimetry 432 subjects 243 normals 189 glaucoma patients were used to validate the NFI A histogram of NFI values from this validation dataset is presented in Figure A 11 D Normal D Glaucoma 0 10 20 30 40 50 FO BO BO 100 NFI Figure A 11 VCC NFI Distribution Validation Dataset GDxPRO User Manual RNFEL Normative Databases and NFI Note that the distribution of normals from the validation dataset is similar to the training dataset However the distribution of glaucoma subjects varies between the two because the training dataset includes both pre perimetric patients and patients with visual field loss while the validation dataset only includes patients with visual field loss Data analysis of the normal subjects used in VCC NFI validation reveals the following e 95 of the normal population shows VCC NFI values under 30 e 99 of the normal popula
64. 2 4 e Setting the Time and Date page 2 5 e Setting Up Operator Doctor page 2 6 e Setting Up a Printer page 2 15 e Setting the Preview Export Image Type page 2 16 Instrument Setup The GDxPRO contains sensitive electronic mechanical and optical components as well as an internal computer Handle it gently Note The GDxPRO weighs approximately 50 pounds 22 5 kg To avoid injury exercise proper lifting techniques when lifting or moving the GDxPRO Note Do not turn power on until all connections are made and all steps are completed 1 Place the GDxPRO on a sturdy table preferably one that is height adjustable 2 Connect the keyboard and mouse to the USB ports on the bottom right side of the GDxPRO Figure 1 6 3 To export reports to a network server or PC connect an Ethernet cable from the network server or PC to the network connector on the bottom right side of the GDxPRO Figure 1 6 4 Optional Connect an external color printer USB or Ethernet cable to the appropriate connector on the bottom left side of the GDxPRO Figure 1 7 Plug the printer power cord into a power outlet Be sure the ink cartridges and paper are installed per the manufacturer s directions See C Printer Configuration 5 Grasp the end of the plastic bag toam objective lens shipping protector and pull it out and away from the face mask Place the protector in a safe place for future transport Remove the lens cap 6 Unlock the GDxPRO optics b
65. 4 Calibrate Touch Screen 2 If the cursor follows your finger press the green check button to complete the Touch Screen calibration Setting the Time and Date At the MAIN screen select System gt Set Time amp Date to display the Windows DATE AND TIME PROPERTIES screen Update the fields as needed When the correct time and date are displayed press OK to close the screen Date and Time Properties Date amp Time Time Zone Internet Time Date Time one PIENE E a a a E 12 3 4 5 6 7 3 6 9 10 11 12 13 14 15 i6 17 18 19 Gy zi 5 7 a a z2 23 24 25 246 27 20 z9 30 ad 2 26 15PM 2 Current time zone Pacific Daylight Time Figure 2 5 Windows Date and Time Properties Screen GDxPRO User Manual Setup Setting Up Operator Doctor To secure patient and exam data only authorized operators which log into the GDxPRO system can access patient data Users logged into the system not assigned to the GDxPRO as an operator will not have access to GDxPRO patient and exam data An operator needs to be added tor each Windows User Account that uses the GDxPRO Note You must be logged into Windows with administrator privileges to create or modify an operator If not logged in as an administrator you will not see the Set Up Operator button on the Main screen By default the GDxPRO will automatically be logged in as an administrator with a User Name of Zeiss and password of November171846 Note If you have more than
66. 7 Txt Yes Mo Figure 8 19 Decrypt Event Log Path Dialog Select Yes to proceed The Event Log text file will be opened in Windows Notepad see Figure 8 20 for an example The date and time for each event is recorded The operator GDxPRO User Manual e your computer network or removable drive File Edit Format wiew Help GDXEVENTLOG1 2007 Txt Notepad System Functions AE is recorded at the end of each event You can save the Event Log File to any location on 1 3 2007 1 4 2007 1 4 2007 1 4 2007 1 4 2007 1 4 2007 1 4 2007 1 4 2007 1 4 2007 1 4 2007 1 4 2007 1 4 2007 1 4 2007 1 4 2007 1 4 2007 lt 258 742 743 743 743 743 743 743 43 743 743 743 743 50 49 gt 54 16 22 t2 232 25 30 35 40 47 52 23 38 10 14 18 24 27 31 36 41 46 52 56 32 update update update update update update update update update update update update Measurement Measurement Measurement Measurement Measurement Measurement Measurement Measurement Measurement Measurement Measurement Measurement 0008 0008 0008 0008 0008 0008 0008 0008 0008 0008 0008 0008 Login 0001 000 000 000 Update Update Update Update Update Update Update Update Update Update Update Update Logout Measurement Measurement Measurement Measurement Measurement Measurement Measurement Measu
67. 8 SDO O e en ee eer eet ene een ere re ener 1 8 e External Device EQuipMent ccccescsscsscstsstssessessessessresseeeees 1 8 eInstrument Installation ccccccccssesssseesssseeeeseseeeeesseeeeessseeeeessanens 1 10 TIPS to Avoid DaMage cscscsssescessesessessessseeseeesensaeesessaesseesaeeas 1 10 e GDxPRO Embedded Windows License naseer 1 12 Product Compliance nessa canta giesbedetenaessiondeasees 1 13 e User Changes to Software or Hardwate cccccscsssssssssseseenrees 1 13 SAE uprana eonneeaie numa 1 14 e Electromagnetic Compatibility EMC cccscsscssessessesseeseeees 1 16 SYMNOIS and Lapelsssssiriesisia 1 20 e Product Labels and Serial Number Location 1 22 e Instrument Disposition sssssssssssesseesnessrensnensnsrrnsrnsrnnsernennnnnnnenen eas 1 23 GDxPRO User Manual 2 SOC iaai aahi i 2 1 Chapter OVEIVICW visi cdsitarcchadesdterteneesindivataseasidaacestcanctadccaaivelinacunstedaces 2 1 SNS Ume INU SCUD eaten eee aunt itetoaetiea as raauene ste 2 1 locking tne 5 VS LU sci cocasencsiaraue sean ec panscasonshenaunosasaaaatuase ooniessanoet 2 2 e Powering Up the Instrument acsiccakvcesisncumis dotecswseneisedstasdelsadssendcanemnanats 2 2 e Powering Down the InstruUment s ssssnsseisisisesnsissrrrsirisisrsrsrrererresen 2 3 e Operating the Touch SCr M cssesccseessessessessecsseesecsseeseeseeneseaes 2 4 e Calibrating the Touch SCre N ecccssesssssssssssessssssseerss
68. 9 USB Ports 1 7 1 8 User Account 2 9 User Manual F1 Function Key 1 4 vV VCC 4 1 4 11 VCC Exam 5 3 Video Port 1 9 View Full List Button 3 6 GDxPRO User Manual wW Warranty E 1 Defined 1 White Ball 4 9 Windows XP License Location 1 12 Workflow Single Exam 4 4 Triple Scan 4 28 Index J 7 o J8 Index GDxPRO User Manual ttal 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 WWww meditec zeiss com EC REP Carl Zeiss Meditec AG Goeschwitzer Strasse 51 52 07745 Jena Germany Phone 49 36 41 22 03 33 Fax 49 36 41 22 02 82 info meditec zeiss com WWW meditec zeiss com CE 2660021 128483 C GDxPRO User Manual System Software Version 1 0 Specifications subject to change Carl Zeiss Meditec is the manufacturer of medical devices and associated stand alone software Product safety certification refers to the medical device
69. Accept or OK to create the mean and go to the REVIEW CALCULATIONS screen see Final Step Saving the Scans on page 4 25 r amp Note The Triple Scan images reside on the GDxPRO as single nerve fiber layer maps sorted by exam time GDxPRO User Manual Scanning Procedures GDxPRO User Manual Managing Measurements aa 5 Managing Measurements Chapter Overview This chapter describes how to select measurements and generate different types of reports Topics covered in this chapter include e Automated Report Generation Summary page 5 1 e Selecting Measurements page 5 1 e On Screen Exam Review page 5 5 e Printing Exporting Exams page 5 6 e Deleting Measurements page 5 7 e Creating a Mean Measurement Manually page 5 8 Automated Report Generation Summary GDxPRO offers automated report selection for ease in generating reports Follow these steps to generate a report 1 Select the patient you want a report for see Selecting an Existing Patient on page 3 5 2 On the PATIENT INFORMATION screen select Review to display the MEASUREMENT LIST screen 3 On the MEASUREMENT LIST screen the software automatically selects measurements for the report see Auto Selection on page 5 4 4 On the MEASUREMENT LIST screen select Review or OK to display an on screen report The report depends on the type and number of measurements selected see On Screen Exam Review on page 5 5 To print the report without review select the
70. Browse Example server share e Reconnect at logon Connect using a different user name Sign up For online storage or connect to a network server Cancel Figure B 2 Map Network Drive Dialog 5 In the Drive field select any available network drive letter using the down arrow on the right You may for example choose N for network storage device e In the Folder field note that the folder name is already selected and unavailable to be changed e Do not clear the Reconnect at logon check box 6 Click Finish You have now completed configuration Cleaning the NAS Device Regular periodic cleaning of the NAS device is not required However if the device becomes dusty you may clean it using a soft bristle brush such as a keyboard brush Do not use liquid cleaners unless specifically directed by the manufacturer since they may drip into the device and cause it to malfunction GDxPRO User Manual Network Storage Device Configuration GDxPRO User Manual Printer Configuration am C Printer Configuration Introduction This appendix instructs you how to configure a printer for use with the GDxPRO These instructions provide requirements and recommendations for the printer but are generic with respect to brand although one may be supplied with the instrument Specific configuration instructions vary by printer and users are advised to closely follow the instructions supplied These instructions cover two config
71. CC B1 Dr Jones 5 28 2002 11 33AM VCC B2 Dr Jones Recall MEASUTEWENIG 5 28 2002 11 37 AM Ref Dr Jones Reference Image identified 5 28 2003 11 11 AM Jones with Ref in Mode column 5 28 2003 11 19 AM Jones 5 28 2003 11 23 AM _ Jones 11 17 2003 11 42 _ Jones 11 17 2003 11 48 Jones iii ERG IAE 2003 14 5t Jones Comment Set Baseline Set Reference Delete Exclude Figure 7 3 Measurement List Screen Additional Buttons Setting the Reference Image for Automatic Image Alignment Retinal blood vessels are used as landmarks to align all images for a given eye to a single reference image This step is required for mean image creation and progression analysis Once the images are aligned the ONH and macular ellipses from the reference image are copied to all other images If using Triple Scan mode the first image is selected as the reference For Single Exam mode the image with the highest Quality Score Q out of the first three is automatically selected when first needed The operator can override the automatic selection The operator is asked to verify the ONH ellipse and the macular circle placement in the reference image Only one reference can be set per eye It is identified by Ref in the Mode column of the MEASUREMENT LIsT screen Figure 7 3 ms Note SCC FCC and excluded images cannot be automatically or manually selected as the reference image oa Note The size of the ONH ellipse is i
72. CHECK screen for the selected image s See Checking Image Quality on page 4 13 for information on this screen Note Carl Zeiss Meditec does not offer advice in the diagnostic interpretation of GDxPRO scans It is the clinician s responsibility to make diagnostic interpretations of GDxPRO scans GDxPRO User Manual Quality Indicators Q gt 7 recommended Residual ECC lt 4 Residual VCC lt 12 TSS ECC gt 40 TSS VCC gt 60 Fundus Image Reflectance image showing the optic nerve head ONH RNFL I Summary Parameters Table Color coded parameters indicating comparison to normative limits All except the NFI are calculated only from the Calculation Circle Nerve Fiber Layer Map An hourglass shape of yellow and red colors around the ONH is typical of normal eyes NFI Nerve Fiber Indicator is related to the likelihood that the nerve fiber layer map is abnormal Deviation Map Color coded indicating comparison to normative limits TSNIT Graph Displays normal range shaded area and patient s RNFL I values along the Calculation Circle Symmetry Analysis Overview of the Symmetry Analysis Report Name Symmetry Example1 ID S1 DOB 12 31 1955 Gender Male Ancestry Black GDxPRO Symmetry Analysis Q 9 TSS 100 Residual 4nm Single Scan 02 12 2008 09 43 Exam Date Exam Time Operator Physician 02 12 2008 09 44 zkunezyn Imported Im
73. D PhD C G i Hamilton Glaucoma Center a University of California San Diego Inferior Average a 7 D Age 68 7 71 72 7 4 7 7 7 78 Exams 1 2 3 4 5 06 17 2004 16 02 06 17 2004 16 05 06 19 2006 14 02 06 19 2006 14 08 06 19 2006 14 10 TSS 98 TSS 96 TSS 95 TSS 98 TSS 99 Q 8 Q 8 Q8 Q8 Q8 Single Single Single Single Single Baseline Baseline A ka e p p p ko S N Nerve Fiber Layer Map Pa K A A f i Pg 0 af 0 140 NS p Pa Shag Pa S a um Ded gt lt gt lt a wwe Mei wee NS yr Si ge S ar gt lt lt a N i i ys Progression Map i Physician Interpretation Physician Signature GDxPRO All rights reserved Software Version 1 Figure 7 15 Example 1 Focal Change with Data Acquired from Two Instruments GDxPRO User Manual Guided Progression Analysis GPA Example 2 Inferior Change Identified by All Approaches This report Figure 7 16 on page 7 19 can be evaluated as follows 1 Verify data quality e The Quality Scores of all images are gt 7 and the TSS scores are gt 40 for ECC or gt 60 for VCC There are no alignment errors e The baselines are consistent 2 Examine GPA printout e Summary box All three analysis tools have red check marks all corresponding to an inferior change e The Interior Average RNFL Summary Parameter Chart reports the rate of change is 10 8 9 P um year The analysis was performed with only 1 year of data and more f
74. D RW rewriteable CD e DVD R writable DVD e DVD RW rewriteable DVD Note The optical disks you use must first be formatted as explained in the section Disk Formatting on page D 3 Compatible Data Transfer Functions Optical disks can be used for all export and import functions Export and Import You can burn an GDxPRO export database to an optical disk for transfer to another GDxPRO instrument Note On a PC it may be possible to view and analyze GDx data using third party software Beyond the instructions here Carl Zeiss Meditec does not support the import of GDx data to a PC neither do we specify third party software you can use on a PC to view and analyze GDx data nor support its use Data Transfer Instructions The actual data transfer functions export and import are done using the GDxPRO software in the usual way except that you select the optical drive as the target or source drive for data transfer and you insert a compatible formatted disk in the optical drive The Export Data function exports all information required to regenerate the database To perform the Export Data operation at the MAIN screen select System gt Database gt Export Data A Browse for Folder dialog will open where you can select the folder for the data export Selecting the optical disk drive will initialize burning of a CD DVD GDxPRO User Manual Show Drag bo Disc keep In Front Settings View Disc Contents Disc Proper
75. Deviation TSNIT Plot Position 14 Table A 3 ECC Repeatability and Reproducibility Glaucoma Study Eyes Age Coefficient Analysis of subject demographics determined that expected RNFL I was dependent upon age Thus age correction is incorporated into the calculated results Subject ethnicity race was self reported by the subjects in the population comprising the normative database but was not used as a variable in constructing the RNFL normative database As shown in Figure A 1 Figure A 2 Figure A 3 the data for TSNIT Average Superior Average and Inferior Average comprises multiple data points Linear regression analysis was used to determine the age coefficient The three figures present RNFL measurements versus age and suggest that RNFL decreases with increasing age RNFL4 P um MEE EN EPAR AAN AE gel om a 9 Age Figure A 1 TSNIT Average RNFL I for Small Calculation Circle Versus Age GDxPRO User Manual RNFL Normative Databases and NFI A 7 RNFL I P um Age RNFL4 P um Figure A 3 Inferior Average RNFL I for Small Calculation Circle Versus Age GDxPRO User Manual RNFEL Normative Databases and NFI ECC NFI Development The NFI is a global parameter that uses a machine learning classifier to analyze the entire RNFL profile It is expressed as an ordinal number from 1 to 100 related to the likelinood that the polarimetric retinal nerve fiber layer map is abnormal A higher number is more likel
76. Doctor 2 6 Refraction 4 29 Changing 4 7 Manual 4 8 Registration see Automatic Image Alignment Regression Line 7 13 Color 7 14 Remote Support 8 24 Removing Hard Disk Drives E 4 Replacement Accessories E 18 Replacing the Main Fuse E 4 Report Export Image Type 2 16 Report Generation Automated 5 1 6 5 GDxPRO User Manual Index J 5 Reports Automatic Export 2 16 Content 6 5 Exporting 5 6 6 2 7 4 Printing 5 4 6 2 7 4 Reviewing 7 4 Reset Compensation 4 24 4 29 Reset Settings 8 8 Resetting Baselines 7 14 Residual 6 6 Restart Alignment 4 9 Restore Database 8 9 Retake Image 4 13 4 17 Review Button On Measurements List Screen 5 4 5 5 On Patient Information Screen 3 8 5 1 Review Calculations Screen 4 25 5 6 6 1 7 4 Reviewing Reports 7 4 RNFL 1 1 4 1 4 3 RNFL I Measurement Image Check 4 17 RNFL I Summary Parameter Charts 7 10 7 13 Exams Taken by Different Instruments 7 14 RNFL I Summary Parameters Table 6 10 Routine Maintenance E 1 S Safety 1 14 Printers C 2 Scan Procedure 4 3 4 12 Scan Workflow Single Exam 4 4 Triple Scan 4 28 Scanning Modes 4 1 SCC Exam 5 3 SD Standard Deviation 6 6 Selecting Patients 3 7 Selection Automatic 5 4 Manual 5 5 Serial Number Location 1 22 Service Contract l 2 Set Database 8 8 Index Setting Baselines 7 6 Setting the Reference Image 7 5 Setup 2 1 Instrument 2 1 Printer 8 2 Time and Date 2 5 Shut Down 2 3 Shut Down For Transport Function 2 2 2 4 E 9 SIM
77. Ellipse Measuring Cornea Left 08 Ellipse Diameter Horizontal H Yertical Dotted square indicates that Irregular Pattern is selected the macula pattern is not well defined Cancel Dotted Square Indicates Optimal ONH Centering Irregular Macula Ellipse Pattern Size L Right Figure 4 14 Modify Ellipse Measuring Cornea Screen Irregular Pattern When you have optimized the placement of the corneal measurement ellipse press OK to go to the Mobiry ELLIPSE MEASURING CORNEA screen for the next eye and optimize the placement of the corneal measurement ellipse in the same manner as for the first eye GDxPRO User Manual Scanning Procedures IA When finished press OK and then Accept to go to the IMAGE CHECK MEASURING CORNEA screen Image Check Measuring Cornea OD Right Eye OSs Left Eye Dotted square indicates that Irregular Pattern is selected the macula pattern is not well defined Alignment Fixation Refraction Other Retake Image Modify OD Modify 0S OD Iris Image Macula OS Iris Image Macula Ellipse Ellipse Figure 4 15 Image Check Measuring Cornea Screen oa Note A normal macula is necessary for best results in assessment of the individual corneal compensation ECC and VCC Checking the RNFL I Measurement Upon completion of the RNFL scans as described in Scanning Procedure on page 4 3 review the scan Quality Scores and messages for both eyes on the IMAGE CHEC
78. GDx is a confocal polarimetric scanning laser ophthalmoscope that is intended for imaging and three dimensional analysis of the fundus and retinal nerve fiber layer RNFL in vivo Indications for Use The GDx is a confocal polarimetric scanning laser ophthalmoscope that is intended for imaging and three dimensional analysis of the fundus and retinal nerve fiber layer RNFL in vivo The GDx and its GDx Variable Corneal Compensation VCC and GDx Enhanced Corneal Compensation ECC RNFL Normative Databases aid in the diagnosis and monitoring of diseases and disorders of the eye that may cause changes in the polarimetric GDxPRO User Manual Introduction retinal nerve fiber layer thickness The GDx is to be used in patients who may have an optic neuropathy Note The full range of device settings and anatomical measurement functions of this device has not been validated and the clinical utility of these measurements has not been fully characterized This device is not intended to be used as the sole basis for the diagnosis of disease as the device has not been evaluated clinically for the diagnosis of specific ocular pathologies Note The GDxPRO may not produce reliable results for patients in the following categories e Patients with corneal phase shift greater than 140 nm The system will provide an error message when such a phase shift measurement is detected Patients with dense cataracts Patients with cataracts may have a dark fundus
79. GDxPRO Scanning Laser Polarimeter GDxPRO D User Manual Copyright Carl Zeiss Meditec Inc All rights reserved Trademarks GDxPRO GDx GDxVCC GPA Polarimetric Thickness ECC RNFL Integrity and RNFL I are either registered trademarks or trademarks of Carl Zeiss Meditec Inc in the United States and or other countries Windows is either a registered trademark or trademark of Microsoft Corporation in the United States and or other countries All other trademarks used in this document are the property of their respective owners Document Applicability This document applies to GDxPRO System Software Version 1 0 or higher unless Superseded GDxPRO User Manual Contents i Contents 1 Introductio siani aa aaa 1 1 Chapter OVervi o Wacon a a 1 1 introduction to the GDXPRO sisii a 1 1 SONE a n e ve Rt tT ee nee E O T 1 1 PINCIGAU ONS Tr USO a A 1 1 SNO oroe a ahead A E T 1 2 GDXPRO TECHNOlOJY sin nassscatinie tivigeuieddndddhonndtoriedassindiomedeniebncnelinedhildesatl 1 2 s GDXPRO User Manual cccccccccssssssesseeessseeeesseeeeeseeeeeesesseneeseeeeeeens 1 3 System HardWa e aiscin eaaa ae oa 1 4 Oper OFCON O een a a A T 1 5 TOUSEN Oper Ol a cetncse eds ten tieeh a 1 5 BF CE OO E riea a alten denote eee 1 6 DINE ACESS DOOM Gacuisecara cha tie eee dae teach td aN ees 1 7 SIC SIGS CONNECTOR 17 slet Sae Cned OS es a iii 1 8 EEO T N 1 8 sODXPRO Instrument SOM ANG a ae a 1
80. GDxPRO will default to the patient s last scan mode The scan mode can be changed VCC to ECC or ECC to VCC on the RNFL I Acquisition screen by selecting the ECC or VCC toggle button Figure 4 10 and Figure 4 11 You cannot compare ECC measurements and VCC measurements since they use different normative databases If you select an ECC or VCC button an acquisition message will be displayed Figure 4 9 Select OK to change the scan mode Acquisition You have selected to use a different normative database than for past examinations If you proceed the results will not be comparable to past analyses Figure 4 9 ECC VCC Acquistion Image Mode Change Message nucu If a patient has a corneal pathology or procedure since their last exam it is recommended Compensation to repeat the corneal measurement by selecting Reset Compensation GDxPRO User Manual Scanning Procedures The ACQuisition VCC screen is used to acquire the VCC RNFL measurement __ LERLE T IEL Current scan mode RIEnTOD Single Exam VCC Scan Refraction Auto Age Range 40 49 Ancestry Eastern Select ECC to change the measurement type to ECC Enhanced Corneal Compensation Select Reset Compensation to repeat the corneal measurement Reset Restart Low Vision Figure 4 10 Acquisition VCC Screen The ACQUISITION ECC screen is used to acquire the ECC RNFL measurement _ dM quisition ECC Current scan mod
81. IN screen Editing Deleting Patient Records At the PATIENT INFORMATION screen Figure 3 7 select Edit to edit the patient information Select Delete to delete the patient and all measurements associated with the patient Selecting Cancel will return you to the opening MAIN screen GDxPRO User Manual Managing Patient Records 2 Exporting and Importing Patient s Data ON the PATIENTS List screen Figure 3 6 select Export to export the selected patient s information and measurement data to an export folder You will be asked if you want to use the currently defined default export folder for the current operator see Default Import Export Path optional on page 2 10 Select Yes to use the default export folder or select No to display a Browse for Folder dialog where you can select the export folder you want to use GDxPRO User Manual Managing Patient Records Merging Patients If by mistake you have two patients that should really be the same patient you can merge them into one patient ON the PATIENTS List screen Figure 3 6 select the two patients and then select Merge to merge the measurements of the two patients into one patient A dialog is displayed to confirm the patient merge Figure 3 8 The patient merge option will combine records from both patients selected into one patient Once completed this option cannot be undone are you sure you want to proceed with the patient merge ces Figure 3 8 Confirm
82. K screen Figure 4 17 If they are not satisfactory select Retake Image Press OK and the system will return to ACQUISITION to obtain new scans To obtain a new scan of only the right eye press OK To obtain a new scan of only the left eye select Other Eye The system automatically replaces previous scan s with the new scan s Modifying the Macular Ellipse after RNFL Measurement After completion of the RNFL scans or when reviewing measurements on the IMAGE CHECK screen Figure 4 17 select Modify OD Macula Ellipse or Modify OS Macula Ellipse to see the MobiFy MACULAR ELLIPSE screen Figure 4 16 This screen is somewhat different than the MODIFY ELLIPSE MEASURING CORNEA screen displayed right after taking the corneal measurement The image displays only the macular ellipse region and there is no Irregular Pattern button GDxPRO User Manual Scanning Procedures Modify Macula Ellipse ECC Right OD Ellipse Diameter Horizontal H Yertical Y 930 pm 930 pm Figure 4 16 Modify Macular Ellipse Screen ECC Modifying the ONH Ellipse At the IMAGE CHECK screen Figure 4 17 to change ellipse size or placement select Modify OD ONH Ellipse or Modify OS ONH Ellipse The MoDIFY CALCULATION CIRCLE AND ONH ELLIPSE screen appears as shown in Figure 4 18 The screen displays how the system automatically placed the ONH ellipse It should be placed such that the ellipse is centered over the ONH oa Note If a referen
83. Manual RNFL Normative Databases and NFI A 11 Conclusion The GDx ECC RNFL Normative Database was based upon GDx ECC scans collected trom subjects whom per protocol were deemed representative of a normal population The GDx ECC RNFL Normative Database establishes reference values for GDx ECC scans which the physician can use to compare individual patient measurements to those acquired in a normal population The ECC NFI is a global parameter that uses a machine learning classifier to analyze the entire RNFL profile It was trained using ECC images obtained trom normal and glaucoma subjects GDxPRO User Manual RNFEL Normative Databases and NFI VCC Normative Database and NFI The GDx VCC database was collected based on a study which contained 300 normal subjects and 120 glaucoma subjects The objective of the study was to establish normative limits for GDx VCC RNFL I measurements and to train the Nerve Fiber Indicator NFI Seven centers in the United States participated in the prospective non comparative study using the commercially available GDXVCC device under external Institutional Review Board IRB approval Seven age groupings were categorized for normal and glaucoma subjects 18 29 30 39 40 49 50 59 60 69 70 79 and 80 and older Overall the age distribution in normal subjects was fairly even among all age groups except the 80 years or older group The normative limits for subjects 80 years or older should be used with
84. Measurements 5 7 Index J1 Deleting Patients 3 8 Deviation Map 6 9 Device Connections 1 8 Device Identifier 5 2 Diagnostics 8 16 Different Instruments 7 14 Disk Backup Options 8 11 Display 1 4 Disposition 1 23 Doctor Add or Modity 2 12 Adding 2 11 Assign Patients to Another Doctor 2 13 Attending Doctor 2 6 Create Association 2 10 Delete Association 2 11 2 13 Exam Doctor 2 6 4 25 5 2 Imported Doctor 2 10 Primary Doctor 2 6 Referring Doctor 2 6 Doctor Information Screen 2 14 Doctor List Screen 2 12 Drives Access Door 1 6 DVI I Port 1 8 1 9 E ECC 4 11 Editing Patient Information 3 8 Electrical Requirements H 3 Electromagnetic Compatibility EMC 1 16 Ellipse Corneal Measurement 4 16 Moditying 4 15 4 17 Moditying ONH ellipse 4 20 ONH 4 14 Embedded Windows License 1 12 Environmental Conditions H 3 Equipment External 1 8 Error Messages Handling E 11 Ethernet Ports 1 7 1 8 Event Log File 8 12 8 13 Exam Doctor 2 6 4 25 5 2 GDxPRO User Manual Index Examples GPA Report 7 16 Symmetry Analysis Report 6 3 Exams Save Only 6 2 Excluding Measurements 7 7 Export Data 8 7 DVD Disk Use Restrictions D 5 Export Error Log 8 12 Export Image Type 2 16 Export Raw Data 5 6 Export Report s 5 6 6 2 7 4 External Equipment 1 8 External Monitor 1 9 Eye Alignment 4 9 Eye Level Indicators 1 6 4 5 4 6 F F1 Function Key User Manual PDF 1 4 Face Mask 1 6 4 5 Cleaning E 12 Replacing E 13 FCC Exam 5 3 6 9 Fix
85. Patient ID Last Name or First Name e Select the View Full List button see Scrolling the Full List of Patients on page 3 6 to display all patients currently stored in the database GDxPRO User Manual Patients List Managing Patient Records Direct Patient Search If you know the patient name or ID the quickest way to select the patient is to enter this information into fields on the SEARCH FOR PATIENT screen The currently selected field is shaded reddish brown As each character is entered the database will sort to and display the first of all the patients that meet the criteria detined by the input so far As each additional character is entered the database will be sorted more specitically until sufficient characters have been entered to display the specific patient of choice If the information on the SEARCH FOR PATIENT screen is not what is desired select Clear to begin the selection process again While entering characters in any of the fields the View Full List button may be selected at any time The system will automatically display the PATIENTS List screen Figure 3 6 starting with the first patient meeting the criteria of the characters entered up to that point Patients List Screen The PATIENTS LIST screen Figure 3 6 is displayed with the first patient selected by default The selected patient is shown with a blue background Navigate the patient list by using the previous next page up and page down commands T
86. Patient Merge Dialog oa Note Once completed merging cannot be undone Select OK to continue with the merge of two patients Select Cancel to cancel the merge A RESOLVE PATIENT ID CONFLICT dialog will be displayed Figure 3 9 Resolve Patient ID Conflict Main Database Backup Database Patient ID 12345 Patient ID 415307762 Group ID 133867456 Group ID 13537576 Yersion 0 Yersion 0 Last Modified nja Last Modified nja First Name Dave First Name David Middle Name Middle Name Last Name Sanini Last Name Santini Date of Birth 1 1 1950 Date of Birth 7 31 1948 Gender Male Gender Male Ancestry Yrhite Ancestry White Macular 0D Disable Macular 0D Disable Macular O3 Disable Macular 05 Disable Use Main hange Patient Use Backup Record Record Figure 3 9 Resolve Patient ID Conflict Dialog Select Use Main Record to use the patient information name gender etc from the Main Database shown above for the merged patient and merge the patients Select Use Backup Record to use the patient information trom the Backup Database for the merged patient and merge the patients Select Cancel to cancel the merge GDxPRO User Manual Scanning Procedures a 4 Scanning Procedures Chapter Overview This chapter describes the GDxPRO scanning procedure Topics include e Scanning Modes page 4 1 e Adding New Patient or Selecting Existing Patient page 4 2 e Scanning Procedure page 4 3 e Checking Ima
87. Purchaser s records and it is Your responsibility to preserve the integrity of these files ZEISS is not responsible for the loss of patient files stored on the hard disk floppy discs backup magneto optical discs or backup floppy discs You bear the entire risk as to the quality and performance of the software ZEISS does not warrant that the software will meet Your requirements that the operation of the software will be uninterrupted or error free or that all software errors will be corrected You assume the responsibility for the installation use and results obtained trom the GDxPRO and programs The Warranty does NOT extend to any diskette that has been damaged as a result of accident misuse abuse or as a result of service or modification by anyone other than GDxPRO User Manual Legal Notices ZEISS Should such software prove defective following its purchase You and not ZEISS assume the entire cost of all necessary service repair or correction ZEISS has no liability or responsibility to any person or entity with respect to any claim loss liability or damage caused or alleged to be caused directly or indirectly by any software supplied with the GDxPRO or by ZEISS Every reasonable effort has been made to ensure that the product manuals and promotional materials accurately describe the GDxPRO specifications and capabilities at the time of publication However because of on going improvements and product updates We canno
88. RO c afl AR Meditec Inc All rights reserved Software Version 1 0 Figure 6 10 Example 2 Physiological Cupping GDxPRO User Manual Symmetry Analysis Example 3 Suspected Early RNFL Loss This report Figure 6 11 on page 6 17 can be evaluated as follows 1 Verify data quality e Image quality is acceptable Q TSS and Residual values are within the recommended limits for both images e The Calculation Circles are centered on the optic nerve e The fundus images are evenly illuminated and in focus 2 Assess Nerve Fiber Layer Maps and Symmetry between Eyes Superiorly the OD RNFL is noticeably different than the OS RNFL as seen in the Nerve Fiber Layer Maps and the TSNIT Graph Infero temporally the RNFL is noticeably depressed in the OS compared to the OD Although the Inter Eye Symmetry parameter is within normal limits such local asymmetries are often indicative of early loss 3 Evaluate and Compare Deviation Maps The OS has red yellow and blue squares infero temporally that suggest a wedge defect especially since this pattern is not reflected in the OD 4 Evaluate the NFI and other RNFL I Summary Parameters The NFI values are 32 and 34 which for VCC are outside the range of values found in 95 of the normal population but inside the range of values found in 99 of the normal population None of the global parameters are flagged However if there is wedge defect in the inferior OS it may be too subtle to be fl
89. S SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF IMPLIED WARRANTIES OR CONSEQUENTIAL OR INCIDENTAL DAMAGES SO THE ABOVE LIMITATIONS OR EXCLUSIONS MAY NOT APPLY TO YOU Service Contract In the U S A a Warranty Extension Agreement Service Contract is available after the one year new GDxPRO warranty expires For information call the Customer Service Department at 800 341 6968 GDxPRO User Manual Legal Notices Fm Software Copyright The software program Software included with your GDxPRO is a proprietary product of ZEISS and in certain instances contains material proprietary to Microsoft Corporation These proprietary products are protected by copyright laws and international treaty You must treat the software like any other copyrighted material Copyright Carl Zeiss Meditec Inc All rights reserved Software License Agreement This Software license agreement License is a legal contract between the Purchaser You Your Licensee and ZEISS governing Your use of the Software Opening the sealed package indicates Your acceptance of the terms and conditions of this License If You have any questions concerning this License contact Carl Zeiss Meditec Attention Customer Service 5160 Hacienda Drive Dublin CA 94568 Telephone 800 341 6968 License Terms and Conditions 1 In consideration of payment of the License fee which is part of the price You paid for Your GDxPRO and Your agreement to abid
90. S device through the GDxPRO which could result in electrical shock to the patient and or examiner WARNING Do not use the NAS device or the instrument with an extension cord or a power strip multiple portable socket outlet For additional safety do not plug the NAS device and the instrument into the same wall outlet Failure to observe this warning could result in electrical shock to the patient and or examiner GDxPRO User Manual Network Storage Device Configuration NAS Device Requirements For safety and minimally acceptable performance when used with GDxPRO the user must select a NAS device with the following characteristics e Ethernet cable for direct connection to GDxPRO Unshielded Twisted Pair UTP network cable CZMI recommends using a least a CAT 5 UTP network cable e Drive media formatted using NTFS GDxPRO data is compatible only with NTFS e Approvals The NAS device you select must conform with local agency requirements In Europe CE approval is required In North America UL CSA or equivalent approval is required and FCC approval is required NAS Device Recommendations e Recommended storage capacity At least as large as the GDxPRO hard drive currently 80 GB e Backup solution To maintain redundancy of data backup we strongly recommend you use the backup solution of your choice for the NAS device e You can use multiple NAS devices as a backup solution but when you use two or more NAS devices concur
91. Serial Number Location On the lower left of the right side of the instrument is the product label and serial number sais a mo 3000 60453 B Oe AG 100 240V LR 96697 i 50 60Hz Tm ennn 7 200VA EI 8000 ___ A N 0297 US 5303709 US 5787890 US 6356036 US 6704106 US 6112114 US 7286227 US 7287855 t l Carl Zeiss Meditec Inc Dublin Ca 94568 USA ec reP Carl Zeiss Meditec AG 07745 Jena Germany Figure 1 8 Product Label on Exterior Right Side On the right side a power and fuse label is above the power and fuse connectors Figure 1 9 Power and Fuse Label A small Manufactured month and year label is on the bottom left side of the instrument Manufactured Figure 1 10 Manufactured Month and Year Label A small laser classification label is on the bottom of the instrument Figure 1 11 Class 1 Laser Label A small FDA laser notice label is on the bottom of the instrument Complies with FDA performance standards for laser products except for deviations pursuant to Laser Notice No 50 dated June 24 2007 8937 A Figure 1 12 Laser Notice No 50 Label GDxPRO User Manual Introduction 1 233 Instrument Disposition When it comes time to upgrade the GDxPRO 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 e
92. Typical Scan Score TSS provides a measure of the typicality of the RNFL image In an atypical scan the phase shift profile does not match the known anatomical RNFL distribution and can be characterized by a variable phase shift pattern Atypical scans are more common in pale fundi high myopes and elderly eyes TSS ranges from 0 very atypical to 100 very typical Exams with TSS ECC lt 40 or TSS VCC lt 60 should be interpreted with caution The following figure Figure 6 4 show examples of an atypical and typical scan Figure 6 4 Atypical and Typical Scan Examples Residual Single Images Only Residual represents the error of corneal compensation Exams with a Residual Compensation value gt 4 nm for ECC or gt 12 nm for VCC should be interpreted with caution The normative database study protocols for both ECC and VCC stated that scans with residual compensation gt 12 would be excluded from the study No scans with residual compensation gt 4 were found during acquisition of the ECC normative database therefore such scans should be interpreted with caution in a clinical setting Single Scan Single Images Only Identities a scan as a Single Image as opposed to a Mean Image Mean Image Mean Images Onl Identifies a scan as a Mean Image as opposed to a Single Image SD Standard Deviation Mean Images Onl The standard deviation SD is displayed if the image is a mean of two or three measurements Exam D
93. age at this point 4 In the GDxPRO optical drive install the CD that accompanies the NAS device which will install and run the NAS device configuration program Follow the on screen instructions using the default settings While running the NAS device configuration observe the following recommendations A Installation Type If you are presented with an option to choose a type of installation for example a choice between typical minimal and or custom installation we recommend you choose typical or minimal Do not perform a custom installation unless you have reason to do so and the knowledge and experience required which would be equivalent to that of a network or system administrator B Record Storage Drive Name If you are presented with the option to change the name of the NAS device you can either use the default name or change it at your discretion but in either case you must write it down because you may need it to complete configuration on the GDxPRO You can use the space below NAS Device Name also known as Network ID C Workgroup Name Must Match GDxPRO Workgroup Name If you are presented with the option to change the workgroup name of the NAS device you must make it match the workgroup name of the GDxPRO which is WORKGROUP by default this name is not case sensitive on GDxPRO If the GDxPRO is connected to an office network as part of a different workgroup name then you must u
94. aged The corneal contribution only needs to be measured once per eye and only on the first exam performed on each eye The corneal compensation value for each eye is stored in a database and will then be used for all subsequent exams for that eye However you may choose to remeasure the corneal contribution to reestablish or update its value for example following patients with corneal procedures or pathology prior to a new RNFL exam The scan procedure described in this section applies to the AutoFocus Scan Corneal Scan and the Single and Triple compensated RNFL scans ECC or VCC The procedure is the same for all scans The scan procedure is detailed in the following Step sections e Step 1 Positioning the Patient on page 4 5 e Step 2 Selecting Patient Fixation on page 4 6 e Step 3 Determining the Focus on page 4 7 e Step 4 Acquiring the Image on page 4 8 For image quality procedures see the following section e Checking Image Quality on page 4 13 At the end of exam acquisition see the following section e Final Step Saving the Scans on page 4 25 Depending on the scanning mode the subject and operator the typical exam time is between 2 and 5 minutes Single Exam To perform a Single Exam select Single Exam or OK on the PATIENT INFORMATION screen Figure 4 1 See Figure 4 2 for the Single Exam workflow for new and existing patients Triple Scan To perform a Triple Scan select Triple Scan on the PATIENT INFORMATION scree
95. agged in the RNFL Summary Parameters Table 5 Apply Symmetry results in context of the patient The results are suspicious especially because of the interior asymmetry and warrant a careful evaluation of other data GDxPRO User Manual Name Symmetry Example3 ID S3 Exam Date 09 21 2004 DOB 11 03 1959 Exam Time 11 36 Gender Male Operator zkunczyn Ancestry Black Physician Imported GDxPRO Symmetry Analysis Right Fundus Image Q 9 TSS 100 Residual 4 nm 11 36 Nerve Fiber Layer Map Sample courtesy of Joseph Sowka OD FAAO Professor and Director of Glaucoma Services Nova Southeastern University College of Optometry Ft Lauderdale Single Scan 09 21 2004 RNFL I Summary Parameters TSNIT Average 51 9 Superior Average 58 5 Inferior Average TSNIT Std Dev Inter Eye Symmetry NFI TSNIT Graph T S N T The NFI is not intended to be used as the sole basis of diagnosis for disease Symmetry Analysis yaa Imported Variable Corneal Compensation VCC Left Fundus Image Q 9 TSS 85 Residual 4nm Single Scan 09 21 2004 11 36 Nerve Fiber Layer Map GDx technology assesses RNFL health by measuring RNFL Integrity RNFL l derived from RNFL thickness and structural organization and expressed in units of Polarimetric Micrometers P um Physician Interpretation Physician Signature Figure 6 11 Example 3 GDxPRO User Manual GDxPRO C
96. al Guided Progression Analysis GPA AX Image Progression Map best for focal change The Image Progression Map Figure 7 8 displays a fundus image with color coded areas showing significant changes in RNFL measurements compared to the two individual baselines Possible progression areas are shown in yellow Likely progression areas in red and Possible increase areas in purple In order to be reported on the summary box an area of at least 750 adjacent pixels must show significant change GPA could theoretically report a change covering an area as small as 2 of the map area Image Progression Map may Figure 7 8 Image Progression Map A warning Figure 7 9 will be displayed if any image in the progression analysis has a Q lt 7 or an alignment problem The exam s causing this warning will display a warning icon in the Nerve Fiber Layer Maps see Nerve Fiber Layer Maps and Progression Maps on page 7 14 Image Progression Map A Warning Check data quality Figure 7 9 Image Progression Map Check Data Quality Warning GDxPRO User Manual Sample courtesy of Robert M Weinreb MD Felipe A Medeiros MD PhD Hamilton Glaucoma Center University of California San Diego Guided Progression Analysis GPA TSNIT Progression Graph best for broader focal change The TSNIT Progression Graph Figure 7 10 plots RNFL values around the GDxPRO calculation circle and shows three curves two
97. alysis Fovea A central pit in the macula that provides the sharpest vision Frame A two dimensional set of data points representing the amount of laser light reflected back from the retina for each point in a given set of scan lines The returning light is split into orthogonally polarized beams and each is directed to a light detector For each detector 32 frames are acquired in a scan each with different modulator position and thus different incident light polarization angles Fundus The posterior interior surface of the eyeball This portion of the retina is visible through the pupil A fundus image is an intensity image generated from the first 8 of the 32 scans acquired during an exam The fundus image excludes all results of birefringence GDx Glaucoma Diagnostics GB Gigabyte A unit of computer storage meaning either exactly 1 billion bytes or approximately 1 07 billion bytes 1 000 megabytes MB is equal to 1 gigabyte GDx Access A legacy instrument that preceded the current CZMI GDxVCC and GDxPRO instrument The GDx Access provided fixed rather than variable corneal compensation The GDx Access performed scans consisting of 16 frames rather than the 32 frames acquired for each ECC or VCC scan on latter instruments GDxVCC Second generation CZMI Glaucoma Diagnostics instrument with Variable Corneal Compensator Glaucoma A group of diseases that result in damage to the optic nerve and retinal nerve fiber layer
98. alysis Chapter Overview This chapter describes the REVIEW CALCULATIONS screen and its corresponding report the Symmetry Analysis report Topics covered in this chapter include e Reviewing Measurements page 6 1 e Overview of the Symmetry Analysis Report page 6 1 e How to Read the Symmetry Analysis Report page 6 4 e Report Contents page 6 5 e Symmetry Analysis Examples page 6 12 Note The GDxPRO and GDxVCC are clinically equivalent and use the same normative databases However some variations may occur whenever the same eye is measured by two different instruments There may also be variances if images are re aligned to a reference image which adjusts the Calculation Circle position Reviewing Measurements The REVIEW CALCULATIONS screen Figure 6 1 is displayed e At the end of exam acquisition when you select Accept on the IMAGE CHECK screen e On the MEASUREMENTS LIST screen when selecting one or two RNFL measurements and selecting OK or Review The REVIEW CALCULATIONS screen displays the measurement results where you can save print preview export a Symmetry Analysis report Figure 6 2 or review image quality Review Calculations VCC OD _ 28 2008 31512008 OS AY ETZ Right Eye AT y A TSNIT Parameters OD Yalue TSNIT Average Superior Average Cancel Inferior Average TSNIT Standard Deviation Inter Eye Symmetry Nerve Fiber Indicator The NFI
99. ameters All of the summary parameters contirm the asymmetry seen in the graphic elements In particular the NFI for OD is 94 but only 10 for OS 5 Apply Symmetry results in context of the patient The results of this Symmetry Analysis suggest extensive RNFL damage in the OD To confirm this damage is due to glaucoma it should correlate with other data such as IOP measurements visual fields and a dilated examination of the optic nerve GDxPRO User Manual Symmetry Analysis E Name Symmetry Example ID S1 Exam Date 02 12 2008 Imported DOB 12 31 1955 Exam Time 09 44 Gender Male Operator zkunczyn Ancestry Black Physician Imported GDxP RO Symmetry Analysis Variable Corneal Compensation VCC OD Sample courtesy of 08 Joseph Sowka OD FAAO Professor Right Fundus Image and Director of Glaucoma Services Left Fundus Image Nova Southeastern University College of Optometry Ft Lauderdale Tawa Residual Residual 4nm 8 nm Single Scan Single Scan 02 12 2008 02 12 2008 i 09 43 09 44 5 Nerve Fiber Layer Map Nerve Fiber Layer Map RNFL I Summary Parameters TSNIT Average Superior Average Inferior Average TRE TSNIT Std Dev 28 6 Inter Eye Symmetry TSNIT Graph T S N I T The NFI is not intended to be used as the sole basis of diagnosis for disease GDx technology assesses RNFL health by measuring RNFL Integrity RNFL I derived from RNFL thickness and structural organization
100. ance can degrade To improve database performance itis recommended that the databases be optimized every month Activate the Optimize command to do this Merge The merge function will merge the database files from a user specified location to the main drive All records are consolidated from the two databases into one database Recalculate The Recalculate Data function will recalculate ALL old data records contained in the databases Export import The Export Data function will export ALL data records contained in the databases The Import Data function will import data records from the specified location into the database Report Export Image Types O oom Auto Export Report After Exam Auto Export Raw Data After Exam Recalculate Optimize Data Export Data Import Data set Database Backup Restore Figure 8 3 Database Options Screen Optimize As with any computer based system the more reading and writing to and from a database the more the data becomes fragmented on the hard disk Therefore the performance of these operations will slow over time The Optimize function packs and re indexes the database for efficiency The system is routinely optimized during the system warm up Only run the Optimize function at the recommendation of the CZM Service department GDxPRO User Manual System Functions At the MAIN screen select System gt Database gt Optimize Figure 8 4 GDxPRO will optimize the database and
101. anty claims shall be as follows when You believe the GDxPRO is defective promptly report the defect to ZEISS Whenever possible We will provide in the customer s office service to repair Your GDxPRO However at Our discretion repairs may be made in Our repair department In this case We will pay all shipping costs unless Your GDxPRO is found upon inspection not to be eligible for repair under this Warranty in which case You will be responsible for one half the shipping costs If Your GDxPRO is ineligible for repair under Warranty We will notify You and any repairs You authorize will be performed at Our normal rates All replaced parts will become the property of ZEISS This Warranty specifically covers the GDxPRO including the instrument table This Warranty does NOT cover consumable items such as operating supplies paper or storage media or the servicing of any external printer Those items will be covered by their manufacturer s warranty and arrangement for service must be made through that manufacturer This Warranty will NOT apply if repair or parts replacement is required because of accident neglect misuse acts of God transportation or causes other than Ordinary use or supplies or accessories that do not meet the proper operating specifications of ZEISS This Warranty does NOT apply to any articles that have been repaired or altered except by ZEISS All data stored on the hard disk magneto optical and or floppy discs are the
102. arl Zeiss Meditec Inc All rights reserved Software Version 1 0 Suspected Early RNFL Loss Symmetry Analysis References 1 Reus NJ Lemij HG Diagnostic Accuracy of the GDxVCC for Glaucoma Ophthalmology 2004 111 1860 1865 2 Da Pozzo S lacono P Marchesan R Fantin A Ravalico G Scanning Laser Polarimetry with Variable Corneal Compensation and Detection of Glaucomatous Optic Neuropathy Grates Arch Clin Exo Ophthalmology 2005 243 774 779 3 lester M Perdicchi A De Feo F Fiesoletti E Amodeo S Sanna G Leonardi A Calabria G Comparison between GDxVCC Parameter and Achromatic Perimetry in Glaucoma Patients Glaucoma 2006 15 281 285 4 Borque E Ferreras A Polo V Larrosa JM Pablo LE Honrubia FM Diagnostic Ability of GDxVCC for Glaucoma Diagnosis Arch Soc Esp Oftalmo 2008 83 357 364 5 Medeiros FA Vizzeri G Zangwill LM Alencar LM Sample PA Weinreb RN Comparison of Retinal Nerve Fiber Layer and Optic Disc Imaging for Diagnosing Glaucoma in Patients Suspected of Having the Disease Ophthalmology 2008 115 1340 1346 GDxPRO User Manual Guided Progression Analysis GPA AE C7 Guided Progression Analysis GPA Chapter Overview This chapter discusses the Guided Progression Analysis GPA Report and related functions Topics covered in this chapter include e Introduction to GPA page 7 1 Fast and Extended GPA Modes page 7 2 Statistical Significance page 7 3 Generating a GPA Report page 7 4
103. ary box e Image Progression Map best for focal change see page 7 11 e TSNIT Progression Graph best for broader focal change see page 7 12 e RNFL I Summary Parameter Charts best for diffuse change see page 7 13 The summary box reports progressive loss as either Possible shown in yellow or Likely shown in red Possible means progression has been detected once Likely means it has been confirmed by consecutive follow up examinations Shown below are examples of summary box displays X Image Progression Map Avy TSNIT Progression Graph Summary Parameter Charts Confirm with additional GDx exams The yellow summary box above shows Possible progression detected by the Image Progression Map Note the message to contirm with additional exams RNFL I Summary OD X Image Progression Map a A TSNIT Progression Graph Summary Parameter Charts Seek clinical correlates A Check data quality The red summary box above shows Likely progression detected by the TSNIT Progression Graph Also Possible increase was detected by the Image Progression Map Possible increase is often due to measurement variability and is therefore displayed with a warning to check data quality The grey summary box below means that no progression has been detected RNFL I Summary OD X Image Progression Map Ay TSNIT Progression Graph Summary Parameter Charts GDxPRO User Manu
104. assing the image quality review only one image per study eye was flagged for inclusion in the calculation data set as meeting the image quality review criteria From this flagged set scans with the following characteristics were excluded e Compensation residual 12 nm or e Typical Scan Score lt 60 Scans remaining after this exclusion process were included in the normative database and the database for NFI training Note that the image quality score was not used as a criterion for exclusion of scans While the GDxVCC does provide the Image Quality Score to assist users in flagging potentially problematic scans this image quality score cannot replace the training experience and judgement of a clinician or operator in deciding whether to discard or accept a particular scan Additional information on the Image Quality Score can be found in Q Quality Score on page 6 4 In practice clinicians and operators should quantitatively and qualitatively review scans for quality Quantitatively a scan with a TSS lt 60 or a compensation residual gt 12 should be cautiously evaluated VCC RNFL Normative Database The following sections describe the makeup of the VCC Normative Database For your information Table A 6 provides data on the overall number of normal study eyes and Table A 7 provides data on the gender race and age of the normal subjects whose scans were included in the normative database Table A 6 VCC Normative Database Nor
105. ate and Time The exam date and time are displayed GDxPRO User Manual Symmetry Analysis am Nerve Fiber Layer Map The Nerve Fiber Layer Map Figure 6 5 is a color map depicting the different RNFL I levels in the 20 x 20 area surrounding the optic nerve head ONH This image presents the unique results provided by scanning laser polarimetry measurements of the phase shift generated by RNFL thickness and structural organization RNFL is represented using a color scale with dark blue representing smaller RNFL I values smaller phase shift and generally bright red representing larger RNFL I values greater phase shift Figure 6 5 Nerve Fiber Layer Map Note GDx technology assesses RNFL health by measuring RNFL Integrity RNFL 1 derived from RNFL thickness and structural organization and expressed in units of Polarimetric Micrometers P um RNFL I is distinct from thickness measured by other devices and expressed as micrometers um A typical normal pattern is characterized by bright yellows and reds thicker in the superior and inferior sectors and greens and blues thinner in the nasal and temporal sectors Deviations from normal may reflect e Lack of the typical RNFL I distribution e Diffuse loss of RNFL resulting in blue areas where you would normally expect yellow or red e Focal defects or areas of concentrated dark colors e Asymmetry between the superior and inferior quadrants e Asymmetry between right a
106. ation Important The GDxPRO Server computer should never be turned off while transferring data In addition hibernation mode and turning off hard drives should be disabled GDxPRO User Manual System Functions E Full Backup Restore The GDxPRO database can be stored in a backup location in addition to the default location by using the Full Backup function For backing up data the user should use this function Just copying the directory will not back up the files in a format the database can recover To perform a full database backup or restore select the System button from the MAIN screen select the Database button from the SysTEMs OPTIONS screen and then the Backup Restore button to display the DATABASE FULL BACKUP AND RESTORE screen Figure 8 10 Database Full Backup and Restore You may fully backup current database to a specified location You may also restore the GDx database from a specified location WARNING The current database and associated images will be deleted during the restore process and replaced with the specified backup database Please contact CZMI service for further instructions OK Cancel Full Backup Restore Figure 8 10 Database Full Backup and Restore Screen Full Backup To perform a full database backup select the Full Backup button to display a Browse for Folder dialog Figure 8 11 where you can select the folder for the backup Browse for Folder Enter the Database Folder B My
107. ation Target 4 6 Flash Drives 1 9 Formatting Optical Disks D 3 Full Backup 8 9 Full List button 5 4 Fundus Image 6 5 7 16 Fuse Holder 1 7 Fuses Check and Replace E 2 Replacement E 1 G GDx Device Identifier 5 2 GDxPRO Contraindications 1 2 Hardware 1 4 Turning Off 2 3 Turning On 2 2 Gender Screen 3 4 Glaucoma 7 1 GPA 7 1 GPA Algorithms 7 1 7 2 7 3 GPA Modes 7 2 GPA Report Examples 7 16 How to Read 7 9 Overview 7 8 Summary Box 7 2 Guided Progression Analysis 7 1 H Handling Requirements 1 21 Hard Disk Drives Access Door 1 6 1 7 Defragmentation E 11 Removing E 4 I Image Check Cornea Measurement Image Check 4 14 RNFL Measurement Image Check 4 17 Image Check Measuring Cornea Screen 5 5 Image Progression Map 7 10 Image Quality 4 13 4 20 Checking 4 13 Messages 4 14 F 3 Image Quality Score Q 4 31 5 9 6 5 7 15 Image Registration see Automatic Image Alignment Image Types 5 3 Import Data 8 7 Import Export Path 2 10 2 16 3 9 5 6 6 2 7 4 Imported Doctor Associating 2 10 Interior Average 6 10 7 13 Installation Requirements 1 10 Instrument Change 7 14 Disposition 1 23 Installation 1 10 Setup 2 1 GDxPRO User Manual Index J 3 Inter Eye Symmetry 6 11 Iris Image 4 23 Irregular Pattern 4 15 4 16 Isolation Transtormer 1 9 J JPEG 2 16 K Keyboard 1 4 1 5 1 7 L Labels 1 22 Laser Safety 1 22 Legal Notices l 1 License Agreement Software 1 3 License Terms and Conditions Software 1 3
108. ay with the hard drive drawer when fully loosened Master Hard Drive Hard Drive drawer l aan Locking screws Back up Hard Drive Hard Drive drawer 130 Eaa A T nh j f j f ip i Bef ii i i iz E r i fii ERN GDxPRO User Manual Maintenance E7 7 When inserting the hard drive drawer make sure to guide the hard drive drawer into the rails on each side Rails 8 Push the hard drive drawer all the way in Push past the initial resistance until you can feel the connector in the back of the hard drive drawer engage 9 The front screw tab should be flush with the mount and the locking screw can now be tightened clockwise till snug with a flat blade screw driver WARNING ie een L Foes PL ieee mi rad Ge LROCALL IOS HARE Flush with mount saat GDxPRO User Manual Maintenance 10 Re install the drive access door at an angle by inserting the alignment tabs to the right of the drive door into the slots in the housing Alignment Tabs 11 Once the drive door is completely installed turn the drive access door locking screw about 3 4 of a turn clockwise using a flat bladed screw driver to lock the drive door 12 The power cord can now be re inserted and the power switch next to it can be turned back on GDxPRO User Manual Maintenance E 9 Transporting Note The optics of the GDXPRO may be damaged if the system is jar
109. be due to e If a reference image has been selected preview the anatomical variation which makes the ONH printout to check for alignment flag If there is a flag position too low or high in the scan field retake RNFL scan or change reference image If due to anatomical variation no action is required e If no reference image selected adjust ellipse placements as necessary Possible refraction e Possible improper focus e Perform AutoFocus scan and retake image setting error Analysis confidence low e Excessive atypical scan artifact e Switch to ECC if applicable or interpret results with Results could be e Error in corneal compensation caution unreliable e Repeat RNFL scan If necessary repeat both the corneal and RNFL scans Ellipse may be too big e Refers to Calculation Circle which may be too e Reduce Calculation Circle size if applicable or interpret Exam comparisons may close to the edge of the image results with caution be affected Recommend resetting e Errors in corneal compensation e Repeat RNFL scan if it has suspected flaws Otherwise compensation repeat both the corneal and RNFL scans STD SD gt 8 5 e Significant variability between images composing Obtain additional images to generate a new mean the mean image Alignment Warning Icon Image not well aligned to reference inconsistent e Retake RNFL scan or change reference image Symmetry Analysis patient fixation
110. bined AutoFocus measurement indicator Imaging to Cancel A T X pir 3 a7 ia i Es 7 eee 7a a Roker aie ie Te ae kis es 8 a aro H aa a z E Set AutoFocus Restart Low Vision Figure 4 6 Acquisition AutoFocus Screen The system will initially be in position to scan the right eye first Aight OD will be displayed on the top left of the screen If you want to skip to the other eye wait for the Please Wait message to disappear and select Other Eye Ask the patient to remain still and focus on the fixation target see Step 2 Selecting Patient Fixation on page 4 6 GDxPRO User Manual Scanning Procedures a Eye Alignment Center pupil in yellow crosshairs by touching or left clicking the mouse on center of pupil and using Pupil Alignment Controls shown below or keyboard arrow keys Center white ball on the horizontal red line using the scroll wheel on the mouse Vertical Controls shown below or keyboard PgUp PgDn keys Figure 4 7 Correct Eye Alignment on Acquisition Screen Live Image Align pupil Center the patient s pupil in the yellow crosshairs using the touch screen touch center of pupil and Pupil Alignment Controls Figure 4 7 Note You can also left click the mouse on the center of pupil or use the keyboard arrow keys See Figure 4 7 for an example of correct alignment Align white ball Center the white ball on the horizontal red line using the scroll wheel on the mou
111. c Rename Disc dialog is displayed Figure D 2 Drag to Disc Rename Disc Use this tool to rename the disc Name For Disc in G11 RoxI02 cancel Hep Figure D 2 Rename Disc 3 Enter a new name and select OK to save the name Proper Disk Care We do not recommend that you use optical disks for long term data storage Use should be limited to data transfer between systems Take care to protect these media from damage We recommend you use hard plastic cases when transporting and shipping these media Optical disks are very susceptible to scratches that could render them unreadable GDxPRO User Manual Data Transfer Using Optical Disks Dy Disk Formatting This section explains how to format optical disks using Roxio Drag to Disc as it is installed on the GDxPRO instrument To backup or export requires an optical disk formatted in the Universal Disk Format UDF1 5 Warning Formatting permanently erases any data currently on the disk Application Window Alk 1 Hide Drag to Disc Alk D Keep In Front Alt K General Steps cone Mie 1 Install the optical disk into the GDxPRO optical drive Wait approximately 30 seconds RUC OS aS for the drive to recognize the media type If you attempt the next step before the drive Disc Properties Alk O y o Eject Disc Alt J is ready you will get an error message There is no disk Format Disc 2 To access the Drag to Disc software you do not have to close the GDxPRO software e
112. ce image is already set for the patient then the image is aligned to the reference image and the ONH and macula ellipses are copied from the reference image In this case the Modify ONH Ellipse and Modify Macula Ellipse buttons on the IMAGE CHECK screen will not be shown for all images except the reference image see Setting the Reference Image for Automatic Image Alignment on page 7 5 GDxPRO User Manual Scanning Procedures XON Image Check ECC OD RightEye Diameter Left Eye Diameter 6 12 2008 Y 1489 6 12 2008 Y 1675 H 930 1210 Score Alignment Cancel Fixation Refraction Other Retake Image Modify OD Macula OS Iris Image Ellipse Modify OS Macula Ellipse Modity OD ONH Ellipse Modify 0S OD Iris Image ONH Ellipse Figure 4 17 Image Check Screen RNFL I Measurement Modify Calculation Circle and ONH Ellipse Right OD Ellipse Diameter Horizontal H 1768 pm Vertical 1861 pm Cancel Calculation ONH Ellipse Circle size Figure 4 18 Modify Calculation Circle and ONH Ellipse Screen Position Buttons GDxPRO User Manual Scanning Procedures Positioning the ONH Ellipse To modify the ONH ellipse position ellipse shown in green select the ONH Ellipse Position toggle button The ONH Ellipse Size button is displayed along with the Left Right Up and Down positional buttons as shown in Figure 4 18 Select the proper positioning buttons to cen
113. cess However only the best three based on lowest variability or STD will be selected for the mean GDxPRO User Manual Scanning Procedures yay 3 Acquire the second and third RNFL scans After you accept the images acquired trom the third scan the Review MEAN screen is displayed Figure 4 33 Review Mean OD Right Eye M Q 10 1 30 2007 M Q9 1 90 2007 o M Q9 1 90 2007 Add Exam select Image Seleni Remowe Exam Accept Reference Figure 4 33 Review Mean Screen The Review MEAN screen enables you to evaluate the first three scans quality to accept the scans or to acquire one or two more scans as needed Select Add Exam to go to an ACQUISITION screen to acquire a fourth or fifth Triple Scan ga Note When creating a mean from the MEASUREMENTS List screen the Add Exam button will display a list of previously acquired exams to select rather than an ACQUISITION screen during a Triple Scan If there is no reference image for the eye when performing a Triple Scan a reference image will be automatically created trom the first acquired image See Creating a Mean Measurement Manually on page 5 8 for more information on the REVIEW MEAN screen The Quality Score Q is given for each image and can range trom 1 to 10 with 10 indicating highest quality If the Test Retest Variability is Too High or Marginal for an image the software will prompt you for additional images until five scans have been accepted 4 Select
114. courtesy of Joseph Sowka OD FAAO Professor and Director of Glaucoma Services Nova Southeastern University College of Optometry Ft Lauderdale Example 1 Severe OD RNFL Loss This report Figure 6 9 on page 6 13 can be evaluated as follows 1 Verify data quality e Image quality is acceptable Q TSS and Residual values are within the recommended limits for both images e The Calculation Circles are centered on the optic nerve e The fundus images are evenly illuminated and in focus 2 Assess Nerve Fiber Layer Maps and Symmetry between Eyes In this case there is marked asymmetry between OD and OS The Nerve Fiber Layer Map for the right eye OD is dark blue indicating loss of the RNFL both superiorly and inferiorly The map for the left eye OS reveals the hot colors of red and yellow indicating a more robust and typical RNFL pattern This asymmetry is also displayed in the Deviation Maps and the TSNIT curves The Inter Eye Symmetry parameter is flagged light blue indicating less than 2 of normal patients have such asymmetry 3 Evaluate and Compare Deviation Maps The OD has a very large group of red squares adjacent to the ONH superiorly There is also a large group of light and dark blue squares inferiorly The OS has only small groups of dark blue squares which are quite nasal and temporal and are not adjacent to the ONH and therefore not likely to be clinically significant 4 Evaluate the NFI and other RNFL I Summary Par
115. ction Excluded measurements are also excluded from mean reference image and baseline automatic selection An excluded measurement cannot be included in a baseline set A reference or baseline measurement cannot be excluded os Note Excluded measurements can be manually selected to be reviewed in GPA Symmetry Analysis reports To exclude a measurement select it and then select the Exclude button Figure 7 6 Select the More button it you cannot see the Exclude button You will see a red X through the Eye icon To unmark for exclusion select the Exclude button again The red X on the Eye icon will be removed Measurement List Full GPA Progression Analysis report can be generated by selecting three to eight visits of the SAME type and selecting PrintfExporn Review Operator mwarning Patient Susan Smith Patient ID 7654 Device 014444190A4000079 Primary Doctor Clinic Dr Sullivan Sullivan Divine Clinic Exam Doctor 11 6 2006 12 6 2006 12 6 2006 12 6 2006 12 6 2006 12 6 2006 12 6 2006 Comment WEC TS 09 07 08 50 08 51 06 54 08 54 08 55 08 56 1 6 2007 08 39 1 6 2007 08 40 VCC VEC VEC VEC VEC VEC VEC VEC VCC Dr Sullivan Mera Klean Measurements Dr Sullivan Dr Sullivan Dr Sullivan Dr Sullivan Dr Sullivan OK Dr Sullivan eee Cancel Dr Sullivan Dr Sullivan Set Baseline Set Reference Hore Figure 7 6 Excluded Measurement Remeasuring Corneal Measurements Ove
116. cusses development of the RNFL Normative Databases and NFIs for ECC and VCC e ECC Normative Database and NFI page A 1 e VCC Normative Database and NFI page A 12 ECC is virtually always superior and is therefore the detault VCC is provided for continuity with historical scans While many of the steps in development are similar for ECC and VCC there are some noteworthy differences And recall that ECC and VCC measurements cannot be compared as they use different normative databases ECC Normative Database and NFI The Collection of Normative and Glaucoma Data Using GDx VCC Scanning Laser Polarimetry study was performed to collect data for the development of the ECC RNFL Normative Database and the ECC NFI This study was carried out at ten sites under an Institutional Review Board and Ethics Committee approved protocol Both normal and glaucoma subject data was collected in this study Normal data was grouped into seven categories by subject age 18 29 30 39 40 49 50 59 60 69 70 79 and 80 and older Overall the age distribution in normal subjects was fairly even among all age groups except the 80 years or older group The normative limits for subjects 80 years or older should be used with caution as there are only two subjects in this group It should also be noted that this normative database does not have any subjects younger than 18 years old Glaucoma subjects were categorized into the following three visual field defect
117. d by Patient ID The selected patient s date of birth gender ancestry and middle name are shown at the bottom of the list The total number of patients is also displayed Once the desired patient is selected press OK or double click the selected patient to display the PATIENT INFORMATION screen see Patient Information Screen on page 3 8 Select Cancel if you want to return to the SEARCH FOR PATIENT screen Printing the Patients List Select Print Full Listing to print the complete list of patients displayed on the PATIENTS LIST screen to the currently selected Windows default printer GDxPRO User Manual Managing Patient Records Patient Information Screen The PATIENT INFORMATION screen Figure 3 7 displays the patient information for the selected patient stored in the database Patient Information Name pan lobe Patient ID ioe Date Of Birth jee March 20 1965 Ancestry E Gender Cancel Primary Doctor Clinic je Oppenheimer Hacienda Clinic single Exam Triple Scan Review Delete Figure 3 7 Patient Information Screen At the PATIENT INFORMATION screen select Review to display the MEASUREMENT LIST screen and generate reports see 5 Managing Measurements Select Single Exam or OK to take a Single Exam see Scanning Procedure on page 4 3 or Triple Scan to take a Triple Scan see Acquiring Triple Scans on page 4 27 Selecting Cancel will return you to the opening MA
118. d reference image and select the new reference image Ref will be removed from the measurement s Mode column of the old reference image and Ref will be added to the measurement s Mode column for the newly selected reference Note If the reference image is changed all images aligned to the reference will be realigned Depending on the number of measurements this may take some time Setting Baselines The software automatically establishes the first two qualifying exams as the baselines which are labeled B1 and B2 A second set of baselines can also be established to compare progression before and after an intervention see Dual Baselines on page 7 14 Note There is no limitation for the time difference between baselines although a separation of two to three months is ideal To select different baselines select the measurement you want as B1 and then select the Set Baseline button The selected and next qualifying measurement will then be labeled B1 and B2 in the Mode column Figure 7 3 To remove the baseline select either measurement marked as B1 or B2 and then select the Set Baseline button The B1 and B2 identifiers will be removed trom the Mode column GDxPRO User Manual Excluded measurement Exclude button Guided Progression Analysis GPA AA Excluding Measurements Measurements that are of poor quality or outside of the time period being analyzed can be excluded from automatic sele
119. d supports analog and digital monitors with a resolution of 800 x 600 and 24 bit color the GDxPRO touch screen is only 18 bit color However live eye video is unsupported for analog monitors USB Drives Flash and Hard Drives Do not install any optional software NAS Drives See B Network Storage Device Configuration for more information Printers See C Printer Configuration for more information Isolation Transformer Any isolation transformer used must be approved for medical use and must have a minimum rating that is sufficient for the device s being powered CZM highly recommends contacting your CZM representative for an isolation transformer that has been formally qualified for the GDxPRO Note Technical support is not provided for accessory devices that have not been qualified by CZM GDxPRO User Manual Introduction Instrument Installation Only an authorized Carl Zeiss Meditec service representative should install the GDxPRO Care in Handling Use extreme care when handling and transporting the GDxPRO shipping boxes The instrument contains fragile optics that have been precisely aligned at the factory Installation Requirements The GDxPRO should operate on a dedicated power outlet Based on your specification we configure your GDxPRO at the factory to use either 100V 115V or 230V line voltage An isolation transformer is required when connecting peripheral devices i e printer USB drive monitor e
120. d system performance over time Note Since hard disk defragmentation usually requires several hours to complete we recommend that you start defragmentation at the end of the day and let the process run overnight If defragmentation is not complete in the morning it does no harm to stop defragmentation and continue using the instrument To defragment the hard drive follow these steps 1 Select the Windows key a on the keyboard to see the Windows Start menu e Click Start gt All Programs gt Accessories gt System Tools gt Disk Defragmenter The Disk Defragmenter appears 2 Select the C drive and click Analyze to determine whether the drive requires defragmentation When analysis completes a dialog will appear to inform you whether or not the drive requires defragmentation If it does click Defragment It it does not click Close Disk Defragmenter Analysis is complete For Cs You do not need to defragment this volume view Report Defragment Figure E 5 Sample Disk Defragmenter Analysis Outcome GDxPRO User Manual Maintenance Routine Cleaning amp Disinfecting The face mask and to a lesser extent the imaging aperture lens and LCD screen are the only parts that require routine cleaning and disinfecting Instructions are included below for occasional cleaning and disintecting of the instrument covers and optional power table WARNING The instrument has no special measures to protect against harmful in
121. device to sale by or on the order of a Physician or Practitioner Optical Safety This instrument complies with the following standards and regulations e 21 CFR 1040 10 e 21 CFR 1040 11 e IEC 60825 1 e EN ISO 15004 2 This instrument is classified as follows e Group 1 Instrument Per EN ISO 15004 2 Group 1 instruments are ophthalmic instruments for which no potential light hazard exists e Class 1 Laser Product Complies with 21 CFR 1040 10 and 1040 11 except for deviations pursuant to Laser Notice No 50 dated June 24 2007 The GDxPRO is equipped with two different low power laser devices e The Imaging laser a laser diode 785 nm wavelength with 3 mW instantaneous power and lt 1 mW average power at the cornea that emits directionally variable radiation e The Fixation laser a laser diode 635 nm wavelength with 0 5 mW instantaneous power and lt 1 uW average power at the cornea The GDxPRO is equipped with electronic safety circuitry that constantly monitors the function of the scanning mirrors In the case of a malfunction of any of the scanning mirrors the laser beam is shut off automatically The laser and its associated optics are enclosed in modules within the system s protective housing There are no user serviceable parts inside the protective housing If the unit fails contact CZM for instructions WARNING Do not attempt to open the protective housing of the GDxPRO for any reason Radiation inside
122. down see Powering Down the Instrument on page 2 3 and that the power cord is disconnected from the unit Gently place the GDxPRO on its left side GDxPRO User Manual Maintenance E 3 2 2 Using a narrow bladed screwdriver gently pry open the fuse holder from the side to expose and remove the fuse holder With screwdriver pry open fuse holder from the side Remove fuse holder with fingers Figure E 1 Opening instrument fuse assembly and removing fuse holder Information about the proper replacement fuses is found adjacent to the fuse holder re Fuse type and rating for both fuses Fuse Metric 5A 250 V Slow Blow IEC 127 WARNING Always replace fuses with the same type and rating Failure to do SO may create a risk of fire 3 Slide out the fuse holder and check the filament for breakage Dispose of any defective fuses 4 Insert the new fuse in the holder Slide the holder back into the housing until it snaps closed 5 Gently return the GDxPRO to its upright operating position 6 Plug in the power cord at both ends 7 Your instrument is now ready to be powered on GDxPRO User Manual Maintenance Removing Hard Disk Drives The two hard disk drives in GDxPRO should not be removed without contacting your CZM service representative r amp Note Improper removal of one or both Hard Disk Drives may result in loss of valuable data Do not attempt to remove the Hard Disk Drives in GDxPRO without specific instructio
123. e CETTE Single Exam ECC Scan Refraction Auto Age Range 40 49 Ancestry Eastern Select VCC to change the measurement type to VCC Variable Corneal Compensation i Acquire Select Reset Compensation to repeat the corneal a measurement F i x 3 ssf Reset Restart Low Vision Compensation ee Alignment Tete ae Target Figure 4 11 Acquisition ECC Screen GDxPRO User Manual Scanning Procedures RE Checking Image Quality When image acquisition corneal or RNFL is completed the IMAGE CHECK screen see Figure 4 15 for corneal and Figure 4 17 for RNFL is displayed and should be reviewed before accepting the scan The IMAGE CHECK screen provides the following e Quality Parameters on page 4 13 e Checking the Corneal Measurement on page 4 14 e Modifying the Macula Ellipse after Corneal Measurement on page 4 15 e Checking the RNFL Measurement on page 4 17 e Modifying the ONH Ellipse on page 4 18 e Resizing the Calculation Circle on page 4 21 e Viewing the Iris Image on page 4 23 e Retaking the Image on page 4 23 Quality Parameters Quality parameters listed in Table 4 1 for each image are displayed on the IMAGE CHECK screen Review the scan Quality Scores and messages for both eyes A good quality image can be characterized as follows a scan Quality Score of 7 or above OK s tor Alignment Fixation Retraction and Other parameters well focused well aligned even illumination e min
124. e Import Data operation at the MAIN screen select System gt Database gt Import Data A Browse for Folder dialog will open where you can select the data import folder GDxPRO User Manual System Functions Set Database The Set Database function allows the GDxPRO database to be located on a remote network computer rather than on the instrument To set the remote database on the GDxPRO follow these steps 1 Select System gt Database gt Set Database to display the DATABASE CONNECTION SETTINGS screen Figure 8 9 Database Connection Settings Database Options serverf Computer Name FileServer sQLServer Instance CZM EXPRESS SOLServer password AE AE aE AE 2K oF OK Name Cancel Primary Data Folder Main F Secondary Data Folder Backup A Test Database Change cS Figure 8 9 Database Connection Settings Screen 2 Enter the Server Computer Name for the network location 3 Enter the SQLServerlnstance name SQLServer password 4 Enter the location of the Primary Data Folder which resides on the database server in the Primary Data Folder edit box 5 Enter the location of the Secondary Data Folders which resides on the database server in the Secondary Data Folder edit box 6 Select Test Connection to ensure a successful connection to the central database 7 If needed select Reset Settings to reset the settings to those automatically entered at installation 8 Select OK to test and save the configur
125. e Types and Eye Icon Colors The Exam Doctor field will display the doctor selected on the OPERATOR INFORMATION screen Select the Review Mean button to edit review the exams used to create the mean measurement The REVIEW MEAN screen Figure 5 8 will be displayed Measurement List Full 4 GPA Progression Analysis report can be generated by selecting three to eight visits of the SAME type and selecting PrintfExporn Review Operator dsanini Patient Dave Sanini Patient ID 123 i Bool ear Sen TNERRUNS Primary Doctor Clinic Dr Jones Hacienda Clinic See Exam Date Mode Exam Doctor VCC measurements 1 30 2007 11 10 AM Cornea Dr Jones used in mean ns Mean Measurements 1 30 2007 11 10 AM Cornea Dr Jones 1 30 2007 11 16 AM 1 30 2007 11 16 AM YCC Bi Dr Jones 130 2007 11 20 AM 130 2007 11 21 AM 1 30 2007 11 17 AM YCC B1 Ref Dr Jones 1 30 2007 11 20AM Y CC B2 Ref Dr Jones 1 30 2007 11 20 AM VCC B2 Dr Jones OK Generated mean 1 30 2007 11 21 AM YCC Dr Jones created with 3 es Cancel measurements WE 1 30 2007 11 21 AM YCC Mean Dr Jones Blue Color Icon 1 30 2007 11 22AM VCC Dr Jones Comment Comments are entered here Comments are displayed here Review Mean Set Baseline l List of exams used to generate mean Review Mean button listed by acquisition time Figure 5 13 Generated Mean Measurement GDxPRO User Manual Managing Measurements GDxPRO User Manual Symmetry Analysis Sa 6 Symmetry An
126. e by the terms and conditions of this License and the Limited Warranty ZEISS grants to You a non exclusive non transferable and non assignable license to use and display this Software on a single GDxPRO under the terms of this License If the GDxPRO on which You use the Software is a multi user system this License covers all users on that single system The license is granted solely for the use of Your own internal computing requirements and does not grant You any right title or ownership in the licensed software or its documentation You own the physical media GDxPRO on which the Software is Originally or subsequently recorded or fixed but You understand and agree that ZEISS retains title and ownership to the Software recorded on the original disk copies and all subsequent copies of the Software This Software is copyrighted Unauthorized copying of the Software including Software that has been modified merged or included with other software is expressly forbidden You may not nor may You permit others to a disassemble decompile or otherwise derive source code trom the Software b reverse engineer the Software c modify or prepare derivative works of the Software d provide on line or similar uses to third parties or e use the Software in any manner that infringes the intellectual property or other rights of another party You may be held legally responsible for any copyright infringement that is caused or encouraged by Your fai
127. e the screen sharing session Step 2 You are prompted to download a small virus free plug in Step 3 With your permission your support representative can view your screen and share control of your mouse and keyboard Step 4 You are in full control of your computer at all times You always have overriding control of your mouse and keyboard and you can end the screen sharing session at any time Your Name Company Name Instrument Serial Number Please fill out the fields above type the code you received from your Representative and click the button to proceed Click Here POWERED BY GoToAssist Figure 8 29 Remote Support Web Page GDxPRO User Manual System Functions E CZM Options The CZM Options function System gt CZM Options is used by Carl Zeiss Meditec to set up the GDxPRO system This function is password protected so that only qualified Carl Zeiss Meditec personnel can access it Figure 8 30 CAM Options Password This section of the program is used by Carl Zeiss Meditec to set up the system This includes operations such as calibration This section is password protected so that only qualified personnel at Carl eiss Meditec may use it Cancel Password Figure 8 30 CZM Options Password Screen GDxPRO User Manual System Functions GDxPRO User Manual RNFL Normative Databases and NFI A1 O CA RNEL Normative Databases and NFI Introduction This appendix dis
128. e two bottom hooks engaged in the patient bezel while pushing the top of the face mask towards the bezel GDxPRO User Manual Maintenance 3 Guide the top two snap hooks of the face mask into the two openings of the patient bezel keeping the bottom hooks still engaged 4 Firmly push the top portion of the face mask into the patient bezel to engage the snap hooks GDxPRO User Manual Maintenance E 17 5 om vt B 5 Lightly pull out on the top of the face mask to confirm engagement Contirm that the face mask is flush against the patient bezel on both sides indicating correct face mask installation GDxPRO User Manual Maintenance List of User Replacement Accessories Part Number Description 2660100022511 Power Cord 120 V 2660100022581 Power Cord 220 V 2660021121801 Power Cord China 2660021 121716 USB Keyboard Mini Black 2660021 121631 Keyboard Tray 2660021128483 User Manual 2660021128777 GDxPRO Primer Book subject to availability 2660021128776 GDxPRO Report Analysis Quick Reference Guide 2660021128775 GDxPRO Scanning Quick Reference Guide 2660021114161 Objective Lens Cap 2660021128536 Screwdriver for unlocking the optics box Phillips 2 Variable Optional USB Network Printer Variable Optional Instrument Power Table 2660021128531 Dust Cover Instrument 2660021102326 Antiseptic Wipes Box of 200 0000001345415 USB Mouse Optical 2660100022513 Fuse Metric 5A 250 V SB IEC
129. eady contains export data Only one export database can be present on a CD RW or DVD RW at a time If you attempt to export to a rewriteable disk that already has an export database you will overwrite the previous database Note and Warning It is possible to reuse a CD RW or DVD RW disk for AN export but you must overwrite and in the process delete the current export database You can also re purpose any dedicated CD RW or DVD RW disk but only if you first delete all files on the disk or reformat the disk and thereby permanently erase all data on the disk Roxio Drag to Disc Software Configuration CD R or DVD R Optical Disks To successfully import GDx data trom a CD R or DVD R optical disk to the GDxPRO the Roxio Drag to Disc Eject Options must be contigured to finalize the disk upon ejection enable the disk to be read on any computer as shown in Figure D 7 Do not change the GDxPRO User Manual Data Transfer Using Optical Disks contiguration of the Roxio Drag to Disc software particularly the eject settings The correct eject settings are seen in Figure D 7 below Drag to Disc Settings Drag to Disc 2J Display Settings i Show an icon in the system tray Display the desktop ican when disc is inserted Keep in front of other windows Move to lower right corner on startup Show Drag to Dise on startup Eject Settings C Use the diac in this computer only f Use the disc on other computers or devices
130. ecsadeantccnacesiexaatantcs 7 16 Example 1 Focal Change with Data Acquired from Two Instruments 7 16 Example 2 Inferior Change Identified by All Approaches cccc8 7 18 Example 3 Dual Baseline Analysis Simulated Data 0 c cee 7 20 GDxPRO User Manual 8 A B System Functions 000 innnan anainua 8 1 Chapter OVEN Vi W onran a 8 1 S SV SUC OPION S rursairmcie aie aa 8 1 PMINLEN SEUD orn N 8 2 Set ME T Dale ina i 8 2 SoftWare Update sinandi eiid 8 2 Database ODON sannana aa teneetien 8 3 SODI a a sede ne dne aac ad ines deiod aaoocedesnc homer 8 3 Mer Eaa nore ee rcs aOR TOY ree reenter eee eee ee eee ee 8 4 Be Cal GU a le Da oeer A sda mecneets 8 5 SI FINIORUM GaN EX ONIN GD aU cles cr tore tace E R 8 7 Ser DAS Gennana ean TA e a Pe ohio Pi aerial 8 8 s FUI ACK UI Re SOC derka a E Rieadl ea taacacagcantet 8 9 e Disk Backup ODPtiOns ccccsccsccsessesteccessesseesteesseeseeseeseeeaees 8 11 s EXPOrCEMOT LOO anina A 8 12 PEVENE LOO FING ecirar aN N 8 13 a SVStem DIAGNOSUCS sirien sanna a a aR 8 16 Calibrate Touch Screen sirien 8 23 REMOS SUDDOT isda a a 8 24 CANFODUO NS ornin e acute memacenae seaadeds 8 25 RNFL Normative Databases and NFU ssscccsssssccssessccessseees A 1 LTO UCT eorn R A 1 e ECC Normative Database and NFI esseere A 1 eSelection and Testing of Subjects ccsscescssesetseecssessesesseessseeseees A 1 e nclusion and Exclusion Criteria A 2
131. ee your printers view and change printer settings and set the default printer Figure 2 19 gt Printers and Faxes File Edit View Favorites Tools Help Back gt a pe Search n Folders Hab Address ta Printers and Faxes Documents Printer Tasks R a 1 lal Add a printer ig nagik 6 Sea Set up Faxing See Also 2 Troubleshoot printing g Get help with printing Other Places Control Panel 3 Scanners and Cameras Figure 2 19 Printer Setup Screen GDxPRO User Manual Belg a JLE Status Comments Ready Offline Ready Setup Setting the Preview Export Image Type From the Main Screen select System gt Database to display the DATABASE OPTIONS screen Figure 2 20 Database Options Optimize As databases are used their performance can degrade To improve database performance it is recommended that the databases be optimized every month Activate the Optimize command to do this Merge The merge function will merge the database files from a user specified Select the Report Export Image Types location to the main drive All records are consolidated from the two drop down menu to select the databases into one database Preview Export image type Recalculate The Recalculate Data function will recalculate ALL old data records contained in the databases Export Import The Export Data function will export ALL data records contained in the databases The Import Data function will
132. eessersseeesssersetes 2 4 Setting the Time and Date ccscssescecsescsseesecsseesesssesseesseesereaes 2 5 Setting Up Operator DOCtOM eececeeeeeteseeeesseesseeeseeeeseesseeeaas 2 6 SAGGING MOCIU ZOD OTA OF ennaa a eas ots 2 8 eAssociating Dissociating DOCOM ceeececeeteeeeeeeeeeeeteeeeeereneeeneeeteees 2 10 sAdding Moding DOTON xi aciahactedh cecesncedsn tact Salta dds dade ded atadcaramvads 2 12 SOTENG Up a Prn Or eeiam 2 15 eSetting the Preview Export Image Type eeeseeeeeseteeeeeeeeeeees 2 16 3 Managing Patient Records ssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 3 1 Chapter OVervioW nosnice i ei 3 1 E ntering a New Patientinnen 3 1 Selecting an Existing Patient lt cacisiewtstuctwstacialecnieetivenkiannhetecetins 3 5 DIE CTP AUC SANG ices ceil steals T oeuedge sp uuanee 3 6 SFr PONIES BIST SCL O Osise 3 6 e Patient Information SCrO N cccccesssessscscssscsssssssrsssessesseesersseeeers 3 8 e Editing Deleting Patient Records ccccscsccesscssesccecsscssesesseeeseeseeaees 3 8 e Exporting and Importing Patient s Data cceesseeeessesteeteeeees 3 9 Merging Patile MS cainnean Renata cece asta cus 3 10 GDxPRO User Manual 4 5 Scanning Procedures 0c 4 1 Chapter OVENI OW cni T tidaadescenctsccadiadinednastadaces 4 1 SCAMMIMG Modos ces etseractavsbotstceeciut vec dhatedetins oped talelateentaptadeunteeeds 4 1 e Adding New Patient or Selecting Existing Patient
133. eginning with Visit 3 Simulated Data GDxPRO User Manual Guided Progression Analysis GPA GDxPRO User Manual System Functions a 8 System Functions Chapter Overview Topics covered in this chapter include e System Options page 8 1 e Printer Setup page 8 2 e Set Time amp Date page 8 2 e Software Update page 8 2 e Software Update page 8 2 e Database Options page 8 3 e Disk Backup Options page 8 11 e Export Error Log page 8 12 e Event Log File page 8 13 e System Diagnostics page 8 16 e Remote Support page 8 24 e CZM Options page 8 25 System Options The SYSTEM OPTIONS screen from the MAIN screen select the System button displays software and system information and contains system related functions System Options software and System Information Windows OS Version 5 1 SMMCON Version 001 000 0007 DB Version 4 8 2 1 2 2 2 1 2 1 OPTCON Version 001 000 0012 Sw Version 6 1 1 0 Frame Grabber Version 2 3 2 1 system Serial faJ008013e800d10 Frame Grabber Driver Version 1 0 3 Wednesday July 30 2008 12 55 19 PM Frame Grabber Serial 1600000ebc6c1101 Normative Database Version 1 01 01 OPTCON BootLoader B001 000 0000 SMMCON BootLoader B001 000 0000 a OK Printer Setup en a Tees Cancel Backup Export Error Decrypt Database Options Log EventLog system Diagnostics Remote Support CAH Options Figure 8 1 System Options Screen GDxPRO User Manual
134. eline and Baseline with a icon for the current baseline GDxPRO User Manual Sample data courtesy of Robert M Weinreb MD Felipe A Medeiros MD PhD Hamilton Glaucoma Center University of California San Diego Guided Progression Analysis GPA GPA Examples Following the framework in How to Read the GPA Report on page 7 9 we can analyze the following GPA Report examples Samples courtesy of Robert M Weinreb MD and Felipe A Medeiros MD PhD Hamilton Glaucoma Center University of California San Diego Example 1 Focal Change with Data Acquired from Two Instruments This report Figure 7 15 on page 7 17 can be evaluated as follows e The Quality Scores of all images are within the recommended limits for both images There are no alignment errors The baselines were taken on the same day and the RNFL I Summary Parameter Charts the TSNIT Progression Graph and the Nerve Fiber Layer Maps all indicate the baselines are highly consistent Visits 3 to 5 were taken with a different instrument than visits 1 to 2 as indicated by the blue asterisk on the RNFL I Summary Parameter Charts When exams are taken by different instruments or the same instrument with different calibrations GPA requires at least two readings on each in order to account for inter machine variability This is why although the Nerve Fiber Layer Map for Visit 3 shows inferior loss this loss is not flagged on the Progression Map until Visit 4
135. ep to another sound During the AutoFocus scan the patient may notice the screen briefly going out of focus After completion of an AutoFocus scan the system will remain on the same eye so that the corneal or RNFL scans can be acquired next Corneal and RNFL scan acquisition takes less than one second After completion of a corneal or RNFL scan acquisition of the right eye the system will pause for a few seconds then move to position for the left eye scan The Please Wait indicator will remain red from the time of selecting the Acquire button or the mouse right clicked until the system is in position for the left eye scan If you do not want to scan the left eye press OK to proceed See Checking Image Quality on page 4 13 GDxPRO User Manual Scanning Procedures XIE Acquire Corneal Measurement The ACQUISITION MEASURING CORNEA screen is used to acquire the corneal measurement Figure 4 8 Acquisition Measuring Cornea Current scan mode RIGHT OD Corneal Scan Refraction Age Range 40 49 Ancestry Eastern Auto indicates refraction was set to AutoFocus Corneal measuremen indicator a 7 q amp gt A Restart Low Vision Figure 4 8 Acquisition Measuring Cornea Screen Acquire RNFL Measurements The GDxPRO supports the acquisition of ECC and VCC measurements see Scanning Modes on page 4 1 ECC is the recommended and default scan mode for new patients For existing patients the
136. er quality should be that of a transient burst lines lines typical commercial or hospital environment IEC 61000 4 4 1 kV for input output 1 kV for input output lines lines Surge IEC 61000 4 5 1 kV differential mode 1 kV differential mode Mains power quality should be that of a 2 kV common mode 2 kV common mode typical commercial or hospital environment Voltage dips short lt 5 Uy gt 95 dip in lt 5 U gt 95 dip in Mains power quality should be that of a interruptions and U for 0 5 cycle U for 0 5 cycle typical commercial or hospital environment If voltage variations on 40 U 60 dip in Uz 40 Uy 60 dip in Uy the user of the GDxPRO requires continued operation during power mains interruptions it is recommended that the GDxPRO be powered from an uninterruptible source power supply input lines IEC 61000 4 11 for 5 cycles for 5 cycles 70 U 30 dip in Uz 70 U 30 dip in U for 25 cycles for 25 cycles lt 5 U 95 dip in Uy lt 5 Uy 95 dip in U7 for 5 sec for 5 sec Note U is the a c mains voltage prior to application of the test level GDxPRO User Manual Introduction Guidance and manufacturer s declaration electromagnetic immunity The GDxPRO is intended for use in the electromagnetic environment specified below The customer or user of the GDxPRO should assure that it is used in such an environment Immunity Test IEC 60601 test level Compliance level
137. f 7 or above is desired excellent Alignment Focus dot not centered on The red horizontal line may not evenly bisect the See View Iris Image to red line or pupil not focus dot The pupil may not be centered in the confirm alignment retake centered crosshairs image Fixation Eye movement Patient may have lost fixation or moved Retake image May also cause black border to appear in the image Poor fixation or ellipse Patient may not have fixated on the target Retake image consider Low movement Vision Target Refraction Possible refraction setting Refraction setting entered may not have been Perform AutoFocus scan error accurate and retake image Ellipse may be too big Ellipse may be set too large or too close to the edge Modify calculation circle Exam comparisons may be of the image If the ellipse is improperly placed affected future comparisons may be affected Recommend resetting Corneal compensation incomplete May be due to Reset Corneal Scan compensation poor alignment poor circle placement on Cornea Scan or change in cornea from refractive surgery or other causes Other Analysis contidence low Due to atypical corneal characteristics RNFL Results could be measurements can be affected and the results may be unreliable incompatible with the normative database Image too dark or too Factors could include image out of focus partial For small pupil slight light blinking cataract and small pupil dilatio
138. f the patient Although this patient clearly has large optic nerves and large cups based on the examination the RNFL appears to be healthy in both eyes To contirm this is a case of physiological cupping these findings should correlate with other data such as IOP measurements visual fields and a dilated examination of the optic nerve GDxPRO User Manual Symmetry Analysis QE Name Symmetry Example2 ID S2 Exam Date 03 05 2008 Imported DOB 09 12 1973 Exam Time 14 27 Gender Female Operator zkunczyn Ancestry Black Physician Imported GDxP RO Symmetry Analysis Variable Corneal Compensation VCC Right Fundus Image Sample courtesy of Joseph Sowka OD FAAO Professor and Director of Glaucoma Services Nova Southeastern University College Q 8 7 TSS 40 TSS 70 aria of Optometry Ft Lauderdale saci 11 nm 8nm Single Scan Single Scan 03 05 2008 03 05 2008 14 27 14 27 Nerve Fiber Layer Map RNFL I Summary Parameters TSNIT Average 54 4 Superior Average 60 4 63 6 Inferior Average 70 8 TSNIT Std Dev 27 3 Inter Eye Symmetry 0 89 TSNIT Graph T S N T 20 0 P um The NFI is not intended to be used as the sole basis of diagnosis for disease GDx technology assesses RNFL health by measuring RNFL Integrity RNFL I derived from RNFL thickness and structural organization and expressed in units of Polarimetric Micrometers P um Physician Interpretation Physician Signature GDxP
139. ffers an optional motorized power table which accommodates elevation adjustment to each patient s height The illustrations below label hardware elements System specifications are in H Specifications GDxPRO User Manual Introduction 1 5 Operator Console Power button Integrated Flat Panel Touch Screen Display Mouse Keyboard Figure 1 2 Operator Console Touch Screen Operation Operation of the GDxPRO literally is at your fingertips You can perform all functions whether entering data or selecting a test simply by touching a button on the touch screen An audible beep sounds whenever you touch the screen CAUTION Do not use any sharp objects ball point pens etc to operate the AN touch screen It can be easily scratched GDxPRO User Manual Introduction Patient Console Patient face mask Eye level indicator canthus mark Patient lens Objective lt GDxPRO rrr Figure 1 3 Patient Console Front S Patient face mask Optical and Hard Disk drives access door Optics Lockdown screw hole Figure 1 4 Right Side GDxPRO User Manual Introduction 7 Drive Access Door The Drive Access door provides access to the optical and hard drives See Removing Hard Disk Drives on page E 4 for information on accessing the drives Main Hard Disk Drive Back up Hard Disk Drive Optical Drive Figure 1 5 Drive Access Door Opened Right Side Connec
140. for the current baseline set shown in grey and one for the most recent examination shown in red TSNIT stands for the regions around the optic disc Temporal Superior Nasal Interior and Temporal The GDxPRO calculation circle is divided into 64 segments For Likely progression to be reported on the summary box at least four adjacent segments must show significant change Areas between the current baseline set and the current exam that report significant change are displayed with Likely progression shown in red Possible progression shown in yellow and Possible increase shown in purple TSNIT Progression Graph Sees Baseline Current Figure 7 10 TSNIT Progression Graph The TSNIT Progression Map to the upper right of the TSNIT Progression Graph is displayed to help the user orient the locations of change In this example it illustrates that change was found inferiorly fa Cay Figure 7 11 TSNIT Progression Map GDxPRO User Manual Guided Progression Analysis GPA AE RNFL I Summary Parameter Charts best for diffuse change RNFL I Summary Parameter Charts Figure 7 12 plot three parameter values the TSNIT average Superior Average and Inferior Average Each chart displays parameter data trom 3 to 8 exams plotted in chronological order The vertical axis represents parameter values ranging trom 20 100 P um and the horizontal axis represents patient age spanning 10 years The charts use
141. from Adobe PDF is fixed layout document format used for representing documents in a manner independent of the application software hardware and operating system Each PDF file can encapsulate a complete description of the document that includes the text fonts images and vector graphics that compose the document Phase Shift The magnitude of the delay between two orthogonal components of polarized light PMS Patient Management System PMS is a category of software that deals with the day to day operations of a medical practice Such software frequently allows users to capture patient demographics schedule appointments maintain lists of insurance payers perform billing tasks and generate reports PMS is often connected to electronic medical records EMR systems While some information in a PMS and an EMR overlaps tor example patient and provider data in general the EMR system is used for the assisting the practice with clinical matters while PMS is used for administrative and financial matters Polarimetric Thickness Unique to GDx technology Polarimetric Thickness also expressed as RNFL I is the RNFL measurement of both RNFL thickness and structural organization obtained trom a GDx Units are measured in P um Possible increase RNFL increase that has been detected once Possible Increase is often due to measurement variability Possible progression RNFL I decrease that has been detected once P value A p
142. fuses with the same type and rating Failure to do so may create a risk of fire Environmental Conditions Transport and Storage Temperature 20 to 60 deg C Relative Humidity 10 to 75 non condensing Atmospheric Pressure 50 to 106 kPa Operation Temperature 50 F 95 F 10 C 35 C Humidity 10 75 Atmospheric Pressure 70 to 106 kPa GDxPRO User Manual Specifications GDxPRO User Manual Legal Notices Em Cl Legal Notices Limited Warranty This Warranty gives you specitic legal rights and you may have other rights which vary from state to state For one year from the date of delivery the Warranty Period to the Original purchaser You Your Purchaser Carl Zeiss Meditec Inc ZEISS Seller We Our Us warrants its GDXPRO instrument excluding components and software as stated below the GDxPRO to be free trom defects in material or workmanship In the event of failure Seller s obligation is limited to repairing or replacing on an exchange basis the parts that have been promptly reported as detective by Purchaser during the Warranty Period and are confirmed as defective by Seller upon inspection This Warranty covers all parts labor travel and expenses for the Warranty Period except as otherwise stated herein This Warranty only applies to the original Purchaser and shall not in any way be transferable or assignable The procedure for warr
143. g asking if you are sure you want to turn backups off Figure 8 15 Warning Warning The backup Feature is intended to protect against data loss primarily For the patients and measurements databases IF you turn off backups there will be no protection against Failure of the primary hard drive Are you sure you want to turn backups off Cancel Figure 8 15 Backup Options Warning Dialog Press OK to turn backups off and return to the MAIN screen Press Cancel to keep backups turned on and return to the BACKUP OPTIONS screen If data was saved when the system contained only one functioning hard drive the system will update the replaced hard drive with the data acquired while it was absent When the system is powered up after replacing the hard drive the system will automatically copy the Master top drive contents to the Backup bottom drive GDxPRO User Manual System Functions Export Error Log The Export Error Log function exports all the system s error log files to a user specified folder e g removable media Error log files include the following e Application user displayed errors e g duplicate Patient ID e Hardware hardware specific failures e g laser safety e Database database errors e g creation merge e Focus Stage exercise focus stage step count e Compensators exercise compensator step count e XYZ Table exercise XYZ table axis step count e Modulator exercise modulat
144. ge Quality page 4 13 e Final Step Saving the Scans page 4 25 e Acquiring Triple Scans page 4 27 Scanning Modes The GDxPRO supports five types of scanning modes as described below AutoFocus Scan An AutoFocus Scan is a scan performed at the patient s first visit and is used to determine the optimal focus position Corneal Scan The Corneal Scan measures the anterior segment birefringence using the unique properties of the macular region The results in the macular region of this exam are analyzed to determine the optimum settings for the variable corneal compensator used to cancel out the effect of the birefringence of the cornea for subsequent VCC and ECC exams Single Exam ECC or VCC A Single Exam performs one scan of one or both eyes ECC refers to Enhanced Corneal Compensation ECC measures the retinal phase shift through a mathematical removal of the anterior segment contribution and significantly enhances the signal to noise ratio of RNFL measurements without hardware modification ECC is the recommended and default imaging mode for new patients VCC refers to Variable Corneal Compensation VCC measures the retinal phase shift with direct optical cancellation of the anterior segment birefringence Triple Scan ECC or VCC Triple Scan acquisition allows you to perform trom 3 to 5 consecutive ECC or VCC scans of one or both eyes At the end of the Triple Scan acquisition a mean image from the acquired images is created
145. get Instruct the patient to hold as Steady as possible and to blink normally until told to not blink Standard Target default for new patient When Standard Target fixation is enabled the patient will see the fixation target as two small bright fast blinking red horizontal lights similar to a small equal sign Click the image on the left to see a simulated Standard Target animation Low Vision Target The Low Vision Target is an alternate option for patients that have difficulty seeing the Standard Target When Low Vision Target fixation is enabled the patient will see the fixation target as a bright red dashed rectangle zooming in continuously The center of this rectangle is the fixation target the same small red equal sign of the Standard Target Remind the patient to focus on the center of the box Click the image on the left to see a simulated Low Vision Target animation Selecting the Fixation Target On the Acquisition screen Figure 4 6 select the Low Vision Target button to enable Low Vision fixation Select the Standard Target button to enable Standard fixation On subsequent exams the fixation will default to the last selected target for a given patient GDxPRO User Manual Scanning Procedures HA Step 3 Determining the Focus To correct for the patient s refraction error two options are available manually enter retraction or use the AutoFocus function The GDxPRO uses the refraction information to set the bes
146. gress of water or other liquids classified IPXO ordinary equipment To avoid damage to the instrument and a safety hazard cleaning solutions including water must be applied sparingly with a non linting cloth that is dampened only not dripping wet You must not use aerosols on or near the instrument Face Mask IMPORTANT The instrument parts that routinely contact the patient the face mask should be cleaned with water and disinfected between each examination with an alcohol wipe 70 Isopropyl The Imaging Aperture Lens The imaging aperture should not contact the patient s eye Still you should clean it occasionally or as necessary to remove dust and oily smudges ensuring true images You can use an alcohol prep swab or cotton swab dipped in isopropyl alcohol to disintect you may use the Volk Precision Optical Lens Cleaner Wipe dry with a soft non linting cloth or tissue If the lens inadvertently contacts the patient s eye clean it before proceeding with the examination Note Wipe gently and carefully to avoid scratching the lens Rub gently in a circular motion to remove dirt or foreign matter Do not use harsh materials or chemicals Keep the lens covered with the dust cap when the GDxPRO Is not in use The LCD Monitor Screen Clean the LCD screen when necessary to remove dust and oily smudges that impair viewing Turn off the monitor first We recommend that you use a soft cotton cloth if a dry cloth does not co
147. groups e Early visual field detect The mean deviation MD index is less than 6 dB e Moderate visual field defect MD is equal to or greater than 6 and less than 12 dB e Advanced severe visual field defect MD is equal to or greater than 12 dB Selection and Testing of Subjects All subjects had complete ophthalmic exams of both eyes These exams included Refraction and visual acuity Perimetry using the Humphrey 24 2 SITA Standard threshold test Any defects found were verified with a second test Goldmann applanation tonometry Keratometry Central corneal thickness measurement by ultrasound pachymetry Axial length measurement using an IOL Master Slit lamp examination Gonioscopy GDxPRO User Manual RNFEL Normative Databases and NFI Dilated opthalmoscopic examination Fundus photography and optic disc stereophotography Inclusion and Exclusion Criteria Inclusion Criteria for Normal Subjects Males or females 18 years of age or older Normal Visual Field in both eyes Exclusion Criteria for Normal Subjects Best corrected visual acuity less than 20 40 Refractive error outside 10 00D to 5 00D range Presence of glaucoma or ocular hypertension History of angle closure glaucoma or occludable angles Presence of disc hemorrhage Previous laser and incisional surgery Evidence of diabetic retinopathy macular degeneration or other vitreo retinal disease History of diabetes leukemia AIDS uncontrolled systemic hy
148. he following parameters TSNIT Average This parameter evaluates the average RNFL I P um in the Calculation Circle Superior Average This is the average of all pixels P um in the superior 120 degrees of the Calculation Circle Inferior Average This is the average of all pixels P um in the interior 120 degrees of the Calculation Circle TSNIT Std Dev Standard Deviation This number represents the standard deviation of the values contained in the Calculation Circle The higher the number the greater the modulation of the double hump pattern GDxPRO User Manual Symmetry Analysis HE Inter Eye Symmetry This is the correlation of corresponding points in the TSNIT data for right and left eyes The closer the ratio is to 1 0 the more symmetric the nerve fiber layer Because this is a right lett eye comparison there is only one resulting value rather than one for each eye as in the other parameters If only one eye is evaluated this value is not shown NFI Nerve Fiber Indicator The Nerve Fiber Indicator NFI for GDx is an artificial intelligence algorithm that analyzes the entire RNFL profile It is trained on known normal and glaucomatous eyes and essentially uses pattern recognition to discriminate between them The NFI is an ordinal number that is related to the likelihood that the polarimetric retinal nerve fiber layer map is abnormal A higher number is more likely to be related to abnormality but is not definitive
149. he sort order and filter can be updated by selecting the column header of the field you wish to sort by Last Name First Name Patient ID Exam Date Doctor Steffani Mann Rivastani Ropers Tavers sanders santini ganini Stephanson Susan 9422 3 6 2007 OK Johnson Kelly 1211 3 7 2007 Joseph 443434 11 17 2003 Jones Claus 5322 3 22 2005 Pierre 999971212 6 2 2006 Robbie 6772268 6 12 2006 Leonid 443228 6 19 2006 Allen 992274 8 17 2006 David 415307762 1 16 2007 Dave 12345 3 16 2007 Cancel DOB 07703 1941 GENDER Male ANCESTRY White Number of Middle Name Dawid Patients Listing Figure 3 6 Patients List Screen Scrolling the Full List of Patients If you wish to scroll through the entire list of patients stored in the GDxPRO database select the View Full List button to display the PATIENTS List screen Figure 3 6 GDxPRO User Manual Managing Patient Records tAE Selecting Patients Use the mouse to select a patient or select Previous Next Page Up Page Down to move through the list until you select the patient of interest You may also use the up and down arrow keys and Page Up and Page Down keys on the keyboard You may change the field by which the list is ordered Patient Last Name Patient First Name Patient ID Exam Date or Doctor by clicking on the column header of the field The PATIENTS List screen will remain in this sort order until a new sort is performed The default full list is sorte
150. her number is more likely to be related to abnormality but is not definitive The VCC NFI was trained with the entire GDx VCC database of 480 known normal eyes both eyes of normal subjects included and 215 known glaucoma eyes Gender race and age make ups of the normal subjects and glaucoma subjects in the NFI training dataset are provided in Table A 7 normal subjects and Table A 8 glaucoma subjects respectively GDxPRO User Manual RNFEL Normative Databases and NFI eee pan DDR Eastern n Hispanic n 8 6 7 White n 62 52 1 Median Table A 8 GDx VCC Database Gender Ethnicity and Age Groupings Glaucoma Subjects A histogram of the NFI values from the training dataset 480 normal eyes and 215 glaucoma eyes is shown in Figure A 8 E ona EE aucona m 10 2O z0 40 S0 B0 ra BO Si 100 MFI Figure A 8 VCC NFI Histogram Small Calculation Circle Training Dataset While glaucoma patients were not stratified for disease severity for informational purposes only NFI distributions were generated during data analysis in which the glaucoma GDxPRO User Manual RNFL Normative Databases and NFI A 17 subjects were separated into two categories pre perimetric no glaucomatous visual field damage and glaucoma patients with visual field loss Figure A 9 and Figure A 10 20 15 10 0 a __ O C 0 5 6 11 16 21 26 31 36 41 46 51 56 61 66 71 76 81 86 10 15 20 25 3
151. hin normal test retest variability Figure 7 1 Distribution of Test Retest Variability GDxPRO User Manual Guided Progression Analysis GPA Generating a GPA Report To generate a GPA Report select three to eight ECC VCC RNFL measurements per eye on the MEASUREMENT LIST screen see Selecting Measurements on page 5 1 Fast and Extended Mode GPA reports are created the same way except that Extended Mode reports only include means of three re Note GPA can analyze data from two different instruments but there must be at least two visits from each Factory calibration changes may be treated as a measurement change If you then select Review the system will display a summary of the analyses on the PROGRESSION ANALYSIS REPORT screen Figure 7 2 Progression Analysis Report Ti pi Image Progression Map Report Menu eo AA TSNIT Progression Graph vV Progression Analysis OD Summary Parameter Charts v Progression Analysis OS Symmetry Analysis Image Progression Map Til AA TSNIT Progression Graph Summary Parameter Charts Preview Comparison to Normative DO Pepp e Limits Cancel TSNIT Average Superior Average 4 Preview Inferior Average Nerve Fiber Indicator s i Eaa The NFI is not intended to be used as the sole basis of diagnosis for A ddl da 2 i Sdra disease Analysis yet epes Report s Figure 7 2 Progression Analysis Report Screen Select a Preview button to display the corres
152. hree measurements will be selected up to the first mean of three measurements baseline or the oldest acquired image if a baseline mean of three measurements does not exist GDxPRO User Manual Managing Measurements E If the current measurement is a single or mean created trom fwo measurements then all previous measurements will be selected up to the first single baseline or the oldest acquired image if a baseline set does not exist If the current measurement is the only measurement of the same type from the same instrument only the current measurement will be selected Baselines and reference images may also be automatically set Measurements may be marked for exclusion trom automatic selection See Excluding Measurements on page 7 7 Manual Selection To select measurements first A gh ight one by using the Previous or Next buttons to scroll up and down the list A highlighted measurement is indicated by a surrounding dotted box and a selected measurement has a blue background Only one measurement is highlighted at a time Use Select Deselect to select or deselect the highlighted measurement You can use the mouse by clicking to select one measurement Ctrl click to select multiple measurements or Shitt click on two measurements to select all intervening measurements You may also use the up and down arrow keys and Page Up and Page Down keys on the keyboard to move through the list As a measurement is highlighted or selected a
153. ics from shock and vibration There is no need to insert the screw itis already inside Ea Instructions Insert a Phillips head screwdriver through the larger hole as shown above Pushing against the spring pressure turn clockwise until the screw is engaged Tighten firmly then power down the instrument using the Power button located on the Operator Console IMPORTANT RELEASE THE LOCKING SCREW before powering on the instrument Figure E 4 Shut Down for Transport Screen GDxPRO User Manual Maintenance The PREPARE FOR TRANSPORT Screen provides pictures and instructions for inserting the Phillips screwdriver provided with the GDxPRO accessory kit into the optics lock down screw hole larger of the air vent holes on the right side of the system when facing the LCD Display You are instructed to insert the screwdriver head through the hole engage the spring loaded screw and tighten the screw firmly with a clockwise rotation of the screwdriver Then press the green Power button on the Operator Console Figure 1 2 After the LCD turns off the Power button changes color to amber Turn off the power by flipping the power switch on the bottom right of the instrument to the off position I on O off After transporting the GDxPRO and placing it in a secure position release the locking screw by placing the Phillips screwdriver in the optics lock down screw hole on the right side of the system engaging the spring loaded scre
154. igure 8 22 System Test Screen Single System Test If you feel your system is not operating properly it is recommended that you run the System Test prior to calling CZM customer service in the U S call 800 341 6968 outside the U S contact your local CZM distributor Information on whether or not the system passed the System Test will be helpful to your CZM service representative GDxPRO User Manual System Functions To run the System Test at the MAIN screen select System gt System Diagnostics gt System Test gt Single System Test Figure 8 21 System Test 00 00 02 Please Wait Running System Test t o G 2 Figure 8 23 Single System Test Screen The System Test will run one time and progress during the test is displayed on the LCD display The System Test may be stopped at any time by pressing Esc If the test is cancelled before the end of the test the system may take up to a minute before testing actually stops ga Note Never power down the instrument during a System Test On completion if there were no errors a dialog will display that the test is complete press OK to close the dialog If there were errors or if the test was terminated before completion GDxPRO User Manual System Functions AO errors will be displayed on the SYSTEM ERROR List screen Figure 8 24 Additional information to display is indicated by the scroll bar below the list of errors System Error List system e
155. imal eye movement Potential causes of image quality problems include e improper ellipse placement e image out of focus indicating an incorrect refraction setting e ONH ellipse not centered too close to edge indicating improper fixation e uneven illumination indicating incorrect alignment e an overexposed or black image indicating that the patient blinked during acquisition e black borders along one or more sides of the image indicating patient eye movement during acquisition If the images are not satisfactory select Retake Image see Retaking the Image on page 4 23 In some cases and for some eyes it will not be possible to achieve the recommended score value and avoid all quality messages See Table 4 1 Image Quality Messages on page 4 14 for more information on image quality messages See Table F 1 Image Troubleshooting Guide on page F 3 for additional troubleshooting information Accept the best scan that can be obtained GDxPRO User Manual Scanning Procedures ga __ IMPORTANT Proper ellipse placement influences image Quality Score and messages Verify ellipse placement is correct before deciding to retake an image ga Note Canceling on the IMAGE CHECK screen will discard newly acquired images Table 4 1 Image Quality Messages Quality Message Cause of Message Recommended Action Score Overall score on a scale of Score will always be displayed after scan Retake image 1 to 10 with 10 being A score o
156. indows User Accounts Start gt Settings Classic Start menu only gt Control Panel gt User Accounts GDxPRO User Manual Troubleshooting Zea Table F 1 Image Troubleshooting Guide Issue Message Potential Cause s Recommended Action s e Unclear media patient blink during scan dry e Repeat RNFL scan Make sure patient blinks before eyes improper alignment on the eye scan or use artificial tears e Errors in corneal compensation e Repeat RNFL scan if it has suspected flaws Otherwise e In some patients Q is low because anatomical repeat both the corneal and RNFL scans variation makes the ONH position too low or high The image may be used if the calculation circle is in the scan field entirely contained within the image Image too dark or too e Unclear media e Check for cataract light e Patient blinked improper alignment Repeat scan with more careful alignment on the eye e Improper focus e Perform AutoFocus scan and retake image e Small pupil lt 2 mm diameter e Mild dilation e Retinal curvature or tilted disk e No action required Focus dot not centered e Possible misalignment on the eye during image e See View Iris Image to check alignment retake image on red line or pupil not acquisition if needed centered Poor fixation or ellipse e Possible incorrect fixation or ONH ellipse e If patient cannot fixate properly use Low Vision Target placement placement In some patients could also
157. ing Modifying Operator To add or modify an operator select the Add Modify Operator button from the SET UP OPERATOR screen Figure 2 6 to display the OPERATOR List screen Figure 2 7 Operator List User Domain Default Path C Patient_Data Jack jchin CARL 10636 Cancel ay Previous Delete Modify Figure 2 7 Operator List Screen Use the mouse to select an operator blue background or select the Previous and Next buttons to move through the list until you select the operator of interest You may also use the up and down arrow keys on the keyboard To modity an operator select an operator and then select the Modify button To delete an operator select an operator and then select the Delete button GDxPRO User Manual Setup A To add a new operator select the Add button to display the OPERATOR INFORMATION screen Figure 2 8 Operator Information A valid system user account must be added to the system prior to adding Operator information To view or add system account information select View Create System User Accounts View Create System User Account Operator Domain Cancel Ea Default Import Export Path optional To be associated with Doctor OoOo Associate Dissociate Doctor Save Update Operator Add Doctor Figure 2 8 Operator Information Screen A valid Windows User Account is needed to create an operator Select View Create System User Account to view or
158. ini Cancel Default Import Export Path optional C Patient_Data To be associated with Doctor Dr Oppenheimer k Associate Dissociate Doctor Save Update Operator Add Doctor Figure 2 11 Operator Information Screen with Associated Doctor If you need to add a new doctor select the Add Doctor button to display the Doctor INFORMATION screen Figure 2 18 To dissociate a doctor from an operator select the doctor from the To be associated with Doctor drop down menu and then select the Associate Dissociate Doctor button to display the DELETE ASSOCIATION screen Figure 2 12 Delete association There exists an association between Operator GDXPROBETA103 dsanini and Doctor Dr Oppenheimer Select Yes if you want to remove this association Yes No Figure 2 12 Delete Association Screen Select Yes to delete the association between the operator and doctor The OPERATOR INFORMATION screen will be updated to reflect the dissociation the doctor will be removed from the Associated with field Select No if you do not want to delete the association Select the Save Update Operator or OK button to save the operator information you have entered GDxPRO User Manual Setup Adding Modifying Doctor To add modify or delete a doctor select the Add Modify Doctor button from the SET UP OPERATOR Screen Figure 2 6 to display the Doctor List screen Figure 2 13 Doctor List Navigate the doctor clinic list by using
159. is not intended to be used as the sole basis of diagnosis for disease Preview Export Oe oe Image Check ptions Figure 6 1 Review Calculations Screen Reviewed Measurements GDxPRO User Manual Symmetry Analysis Select Print to print the Symmetry Analysis report to the current default printer At the end of exam acquisition selecting Print also saves the exams Select Preview to display the Symmetry Analysis report in PDF format or a TIFF or JPEG image format See Setting the Preview Export Image Type on page 2 16 to set the image type At the end of exam acquisition selecting Preview does orsave the exams Select Export to export the Symmetry Analysis report to the default export path see Default Import Export Path optional on page 2 10 See Setting the Preview Export Image Type on page 2 16 to set the export image type Select Yes to use the default export folder or select No to display a Browse for Folder dialog where you can select the export folder you want to use At the end of exam acquisition selecting Export also saves the exams Select Print amp Export Options to display the PRINT AND EXPORT OPTIONS screen See Printing Exporting Exams on page 5 6 for information on this screen At the end of exam acquisition selecting Print amp Export Options also saves the exams At the end of exam acquisition select Save Only to save the exams During measurement review select Image Check to display the IMAGE
160. ive Database Section Characteristics of the glaucoma subjects are presented in Table A 5 ora oem oSA Severity of Visual Field VF defect Early VF defects 76 35 Moderate VF defects 72 34 Severe VF defects 67 31 Table A 5 Make Up of Glaucoma Subjects Histograms further detailing the NFI values by visual field loss are presented in Figure A 5 through Figure A 7 This information is provided for your information only no statistical analysis has been conducted to determine if a relationship exists between NFI and varying degrees of visual field defect attributable to glaucoma ECC Database ECC NFI Histogram M 25 E Early m O a J 0 10 20 30 4 A 7 z oo 90 100 MFI Figure A 5 ECC NFI Distribution for Glaucoma Subjects with Early Visual Field Defects Validation Dataset GDxPRO User Manual RNFEL Normative Databases and NFI ECC Database ECC NFI Histogram M 25 0 10 20 30 4 4 7 oo 90 100 MFI Figure A 6 ECC NFI Distribution for Glaucoma Subjects with Moderate Visual Field Defects Validation Dataset ECC Database ECC NFI Histogram M 19 0 10 20 30 4 0 7 z o0 90 100 MFI Figure A 7 ECC NFI Distribution for Glaucoma Subjects with Severe Visual Field Defects Validation Dataset Note that ECC NFI values were created for all three calculation circles The small calculation circle is presented as the default in the current GDx unit GDxPRO User
161. k ports on both devices For the connection to a local area network use two shielded or unshielded network cables Connect the network ports on each device to the corresponding ports on the local area network Connect the power supply output to the printer Connect a UTP network cable to the printer and to the network port on the bottom right side of the GDxPRO Figure C 1 Use one cable to connect the printer and computer directly or two network cables to connect printer and computer separately to a network switch or hub Network Port Figure C 1 GDxPRO Network Connector on Side of Instrument oa Note Use the same kind of UTP network cable in all cases If you connect instrument and printer to the network rather than to each other you will need two UTP network cables Do not use an RJ 45 crossover cable for direct connection between instrument and printer GDxPRO User Manual Printer Configuration 2 Configure the Printer for Network Use Power on the printer and then start the GDxPRO Select the Windows key amp on the keyboard to see the Windows Start menu and Task Bar See the instructions that came with your printer to configure it for network use If available use a Network Wizard program for the printer configuration Install the required drivers only Do not install any optional software Please refer to the GDxPRO Home page www meditec zeiss com GDxPRO for a link to the current list of qualified
162. l Digital Resolution e 256 x 128 pixels x 8 bit Video Camera CMOS e Video FOV Field of View gt 13 3 mm horizontally gt 10 mm vertically e Depth of Focus gt 4 mm e Camera pixel resolution 320 x 240 pixels e Video image pixel resolution 640 x 480 pixels NTSC e Video frame rate 30 frames sec e Camera 0 5 Lux sensitivity e Video image resolution gt 3 p mm Ametropia Correction e 10 to 5 diopters original VCC Systems 13 to 8 diopters for GDxPRO Systems Data Acquisition Time e lt 1 second GDxPRO User Manual Specifications Measurement Repeatability and Reproducibility Table H 1 RNFL I Measurements Repeatability Reproducibility standard deviation P um standard deviation P um AutoFocus Reproducibility e lt 0 25 D standard deviation Measurement Accuracy Retardation measurement e 5 nm measuring uniform linear retarder with retardance in the range of 20 nm to 120 nm Measurement Reliability Image Quality Score Q e Image Quality Score summarizes the overall quality of a SLP measurement Q ranges from 1 poor to 10 excellent A scan with Q lt 7 should be interpreted with caution Typical Scan Score TSS e Typical Scan Score provides an assessment of noise in the RNFL phase shift measurement TSS ranges trom 0 poor signal noise to 100 very good signal noise A scan with TSS ECC lt 40 or TSS VCC lt 60 should be interpreted with caution Corneal c
163. l Panel amp Me Accessibility Options Adjust your comput TE Add Hardware g Switch to Category View T Add or Remove Programs 428 Administrative Tools ty Automatic Updates See Also Date and Time Set the date time om a tends SA Display Change the appear eee Mele Touchscreen Customizes touch s Ci rep ana Suppan cZ Folder Options Customize the displ et Fonts Add change and Game Controllers interr Extreme Graphics internet Options Oy Power Options eS Printers and Faxes Sy Scanners and Cameras W Sounds and Audio Devices Calibrate Touch Screen a Regional and Language Op Installs and trouble Install or remove pr Configure administr Set up Windows to Add remove and c Control the graphic Configure your Inte Sa kevboard Customize your key W Mouse Customize your mo Network Connections Connects to other c bc Network Setup Wizard Launch the Network B Fhone and Modem Options Configure your tele Configure energy s Shows installed prin Customize settings Add remove and c E Scheduled Tasks Schedule computer Security Center View your current 5 Dlsoundmax Control Panel For 50 Change the sounds Figure 8 28 Windows Control Panel Folder The Calibrate Touch Screen function System gt System Diagnostics gt Calibrate Touch Screen is described in the Setup chapter See Calibrating the Touch Screen on
164. layed in the Symmetry Analysis Report as well as in the Progression Analysis Report and on the REVIEW CALCULATIONS Screen Results are based on data extracted from the area defined by the Calculation Circle Calculation Circle The Calculation Circle defines the area where data is acquired for the TSNIT parameters The data acquired in this area also affects the NFI calculation The Calculation Circle appears on reports and is described in Resizing the Calculation Circle on page 4 21 Fundus Image The Fundus Image Figure 6 3 is a reflectance image depicting a 20 x 20 image of the posterior pole of the eye The GDxPRO utilizes more than 16 000 data points from the scan area to produce and display the Fundus Image showing the optic nerve head This image allows the initial quality evaluation of the scan to determine if it is adequate for further analysis and is used for centering the ONH ellipse Q 8 TS3 100 Residual 9nm ra Single Scan 06 05 2007 14 28 Figure 6 3 Fundus Image To the right of the Fundus Image are image parameters described below Image Quality Score Q Q is the Image Quality Score For more information refer to Quality Parameters on page 4 13 e If Q is below 7 an exclamation icon will be displayed next to the Q value GDxPRO User Manual Symmetry Analysis e If the image has an alignment problem an alignment icon will be displayed ll Typical Scan Score TSS TSS is the
165. le population FCC Fixed Corneal Compensation The FCC exam was produced by earlier GDx Access systems which had compensators that were not adjustable The same compensation is used for all patients FCC images can be reviewed and printed but not modified on the GDxPRO Field A portion of a screen display that contains information such as a patient s name or date of examination Fixation Target A point of light that the patient fixates on looks at during the laser scanning process The GDxPRO provides an internal fixation target Standard and Low Vision that is visible while the patient is in the scanning position Flash Drive A flash drive also known as a thumb drive jump drive pen drive or keychain drive is a small portable storage device which unlike a hard drive or optical drive has no moving parts Most connect to a computer via a built in USB port Storage capacity ranges trom as small as 16MB to as much as 64GB and more A flash drive can be used in place of a floppy disk Zip drive disk or an optical disk When the user plugs the drive into the USB port the computer s operating system recognizes the device as a removable drive and assigns it a drive letter Unlike most removable drives a flash drive does not require rebooting after it s attached and does not require batteries or an external power supply GDxPRO User Manual Glossary Follow up exam An exam taken after the baseline exams in a progression an
166. lure to abide by the terms of the License 4 ZEISS may create updated versions of the Software which You may purchase separately NO UJ GDxPRO User Manual Legal Notices 5 This license does not include the right to make copies of software nor to transter the software or copies from the Product s to third parties nor to extract modify or incorporate any part of the software or source code without prior written consent from ZEISS and payment of licensing fees Further sales of GDxPRO instruments may not include any software or software licensee transfers You may not sublicense rent or lease the Software 6 ZEISS warrants the operation of the Software only with the operating system for which it was designed Use of the Software with an operating system other than that for which it was designed will not be supported by ZEISS ZEISS does not claim that the software provided is tree from defects and shall have no obligation to supply software upgrades i e new versions or new or in line releases Acknowledgment You acknowledge that you have read all the provisions in this Chapter including this License and Limited Warranty understand them and agree to be bound by their terms and conditions GDxPRO User Manual Index A Accessories E 18 Acquisition AutoFocus Scan 4 7 Corneal Measurement 4 11 ECC Measurement 4 12 RNFL Measurement 4 11 Suspended F 1 VCC Measurement 4 12 Algorithms GPA 7 2 Alignment Icon 6 6
167. ly to protect data from power failures e Always place the lens cap over the patient lens when not in use e Use the CZM carrying case if transporting the GDxPRO purchased separately e Wrap the GDxPRO in a plastic bag while the unit is in the carrying case to protect the optics from dust What Not to Do to the GDxPRO Never litt the GDxPRO by the face mask Never transport the GDxPRO without locking down the optics head Never subject the GDxPRO to temperatures below 32 F 0 C for more than 15 minutes Prolonged exposure to freezing temperatures may require excessive time to warm up System warm up will fail after 30 minutes Never position the GDxPRO in direct sunlight or near a direct source of heat Never position the GDxPRO in a dusty location Never install any software or utilities on this GDxPRO without prior approval from CZM Any unauthorized modification to the system will void the warranty and any repair costs for damage to the GDxPRO may be billed to the customer Never remove any panels except the optical and hard disk drives access door trom the GDxPRO Never clean with harsh chemicals or detergents Never use fluids or aerosol on or near the GDxPRO These products can damage the GDxPRO surface and affect the delicate optics Never attempt to change any of the batteries in the system Attempting to change a battery can cause damage and loss of data GDxPRO Embedded Windows License Each GDxPRO instrument is
168. m Acquisition The Print Export Print amp Export Options and Save Only or OK buttons will save the exams and display the OPERATOR INFORMATION screen Figure 4 28 where you can change the Doctor Clinic field with any doctor that is associated with the current operator This doctor is called the Exam or Attending doctor and is displayed on the MEASUREMENT LIST screen Figure 5 1 The Exam doctor can be different trom the Primary doctor associated with the patient and defined on the PATIENT INFORMATION screen Figure 3 7 You may also add any comments in reference to the exam in the Comment field Text entered in the Comment field is displayed below the measurements list on the MEASUREMENT LIST screen when the measurement is selected but is not displayed in any report GDxPRO User Manual Scanning Procedures The Operator will default to the currently logged in user You can edit the Operator field if desired Operator Information Operator Doctor Clinic Dr Oppenheimer Hacienda Clinic Comment Optional OF Cancel Figure 4 28 Operator Information Screen Your exam is now complete The system will automatically go to the MEASUREMENT LIST screen see Figure 5 1 on page 5 2 GDxPRO User Manual Scanning Procedures 973m Acquiring Triple Scans The Triple Scan option can be selected from the PATIENT INFORMATION screen Figure 4 29 Patient Information Name fucose Patient ID fie Da
169. magnetic site survey should be considered If the measured field strength in the location in which the GDxPRO is used exceeds the applicable RF compliance level above the GDxPRO should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the GDxPRO Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m GDxPRO User Manual Introduction 1 19 Recommended separation distances between portable and mobile RF communications equipment and the GDxPRO The GDxPRO is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the GDxPRO can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the GDxPRO as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation distance according to frequency of transmitter power of transmitter m wW 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 17 JP d 1 17 P d 2 33 JP For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W
170. mal Eyes GDxPRO User Manual RNFL Normative Databases and NFI A 15 S poma _ Hispanic n 15 6 0 White n 157 62 5 Median Table A 7 GDx VCC Database Gender Ethnicity and Age Groupings Normal Subjects While gender and racial make up of the database is provided above please note that the VCC normative data is not stratified by either gender or race the percentile values provided for comparisons of individual data to the normative database do not take into account differences that may be present due to gender or race ethnicity The table above simply provides this data for your information The GDx VCC normative limits are age corrected The normal RNFL loss with age is small but significant making age matched comparisons an important aspect of the analysis It is estimated that a healthy eye loses roughly 5 000 ganglion cells per year as part of the normal aging process Several studies have used scanning laser polarimetry to document RNFL thinning with age In order to accurately differentiate RNFL changes due to the aging process from loss due to disease the relationship of the RNFL profile with age in the normative database was evaluated NFI Development The NFI is a global parameter that uses a machine learning classifier to analyze the entire RNFL profile It is expressed as an ordinal number from 1 to 100 related to the likelinood that the polarimetric retinal nerve fiber layer map is abnormal A hig
171. ments SE Image types are identified by a small icon at the left of the screen under the Eye column see Figure 5 1 This eye icon is color coded based on the image type and contains the text OD or OS for Right or Left eye respectively Table 5 1 Image Types and Eye Icon Colors Cornea Single ECC VCC Single ECC VCC used in mean Mean of two measurements Mean of three measurements GDxPRO User Manual Cornea is a corneal measurement image performed at the patient s first visit ECC refers to Enhanced Corneal Compensation VCC refers to Variable Corneal Compensation Single ECC VCC used in mean creation A mean of two measurements created by averaging two single ECC VCC measurements A mean of three measurements created by averaging three single ECC VCC measurements SCC refers to Software Corneal Compensation SCC images were produced by earlier GDx systems and can be reviewed and printed but not modified or acquired on the GDxPRO FCC refers to Fixed Corneal Compensation The FCC exam was produced by earlier GDx Access systems FCC images can be reviewed and printed but not moditied or acquired on the GDxPRO Managing Measurements You can view the entire list of measurements or only a list of mean measurements by selecting the Mean Image List button The screen title will change to MEASUREMENT LIST MEAN when you select the Mean Image List button Figure 5 2 Return to the full measurement list by selec
172. mer is required for all externally powered peripheral devices outside this distance unless these devices are 1 connected to the GDxPRO using an Unshielded Twisted Pair UTP network cable CZMI recommends using a least a CAT 5 UTP network cable 2 plugged into a different power outlet than the GDxPRO and 3 qualified by CZM for use with the GDx Failure to observe this warning could result in electrical shock to the patient and or examiner WARNING 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 GDxPRO User Manual gt gt gt gt Introduction 15 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 Avoid tipping Do not use the instrument on an uneven or sloped surface Also do not roll the 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 Federal law restricts this
173. mpletely clean the screen you can dampen the cloth with water only and wipe the screen with the damp cloth Instrument Covers and Power Table Note When dusting of the instrument or table is necessary use a dry non linting soft cloth Do not use aerosols as these can penetrate the instrument covers and damage the instrument Note When the instrument covers or table require cleaning wipe with a non linting cloth or swab dampened only not dripping wet with water Disinfect with an alcohol wipe 70 Isopropyl Wipe dry with a clean and soft non linting cloth GDxPRO User Manual Maintenance E 13 Replacing the Face Mask Follow the instructions below to remove and install the face mask Removing the Face Mask The face mask is captured in the patient bezel with two bottom hooks and two top snap features Indented areas Face mask Patient bezel 1 To remove the face mask from the patient bezel grab the top portion of the face mask with both hands as shown below and push with both index fingers down at the indented areas Push down GDxPRO User Manual Maintenance 2 While pushing down grab the face mask and pull the top portion towards you as shown below Pull out GDxPRO User Manual Maintenance E 15 Installing the Face Mask 1 To install the face mask hold the face mask at an angle and push the two bottom hooks into the bottom openings of the patient bezel as shown below 2 Keep th
174. mportant for the reference image because it is used to mask the ONH area which is not included in GPA The ONH ellipse should be carefully placed to outline the optic disk margin GDxPRO User Manual Guided Progression Analysis GPA To set a reference image select the measurement you want as a reference image and then select the Set Reference button A dialog will be displayed Figure 7 4 Reference Image Please verify accurate fovea and ONH ellipse placement in the reference image The system will duplicate the placement on all subsequent images Figure 7 4 Reference Image Setting Select OK to display the IMAGE CHECK screen where you can verity change the macular fovea and ONH ellipse placements and the calculation circle After verification change select the OK or Accept button to set the reference image The selected measurement is set as the reference image with Ref shown in its Mode column see Figure 7 3 Once a reference image is set the reference image cannot be changed without first selecting another reference image Select another measurement as a reference image and then select the Set Reference button A dialog will be displayed Figure 7 5 Reference Image A reference image is already selected changing the reference will cause existing images to be realigned Are you sure you want to change the reference No Figure 7 5 Reference Image Changing Select Yes to deselect the ol
175. n If a doctor is currently associated with at least one patient you cannot delete the doctor if you do not assign the doctor s patients to another doctor In this case you will be given the option to assign the patient s to another doctor Figure 2 16 There may be patients associated with the doctor Press Yes iF you want to assign the patients to other doctor Yes Mo Figure 2 16 Assign Patients to Another Doctor Screen GDxPRO User Manual Setup Select Yes to assign all the doctor s patients to another doctor and display the SELECT Doctor screen Figure 2 17 If you select No the doctor will not be deleted and you will return to the Doctor LIST screen Select Doctor Select a doctor to assign the patients to Cancel EJ Figure 2 17 Select Doctor Screen Select a doctor from the drop down menu then select Select or OK to assign the doctor To add a new doctor select the Add Doctor button to display the DOCTOR INFORMATION screen Figure 2 18 The Doctor Name and Clinic Name cannot be empty The Doctor Name and Clinic Name combination must be unique Doctor Information Doctor Name Clinic Name E Address C Country zip Code E Telephone Number Figure 2 18 Doctor Information Screen GDxPRO User Manual Setting Up a Printer Setup AE The Printer Setup function System gt Printer Setup will open your computer s PRINTERS AND FAXES window where you can s
176. n Figure 4 1 See Acquiring Triple Scans on page 4 27 for information on Triple Scan exams See Figure 4 30 for the Triple Scan workflow for new and existing patients GDxPRO User Manual Preview lt D OD OS Print lt OD OS ee ne Sa WVE Beisa List Export lt Save Scans Screen Screen Scanning Procedures Single Exam Scan Workflow New and Existing Patient Select Existing Patient Create New Patient Select Single Exam Select Single Exam AutoFocus Corneal measurement and macular ellipse check OD OS gt Iris Image Check Review Corneal P Retake Image Scans Modify Ellipse Scan 0 pue eee gt Retake Image Review RNFL Scans gt Modify Ellipse s Calculation Circle 20 paue gt Retake Image Review RNFL Scans Modify Ellipse s Calculation Circle OD OS Iris Image Check OD Os gt Iris Image Check Not available if reference image has been set Figure 4 2 Single Exam Scan Workflow New and Existing Patient GDxPRO User Manual Scanning Procedures a Step 1 Positioning the Patient IMPORTANT The face mask should be cleaned with water and disinfected AN between each examination with an alcohol wipe 70 Isopropyl Clean all patient contact surfaces of the face mask with an alcohol pad before each patient Allow the alcohol to evaporate before
177. n retake image or lt 2 mm diameter retake AutoFocus scan Checking the Corneal Measurement Atter acquiring the Corneal Scan two macular images a fundus image and a thickness polarization image appear at the top of the IMAGE CHECK MEASURING CORNEA screen Figure 4 15 for each eye scanned The center two images are fundus images The outer two images are the corresponding uncompensated thickness phase shift images that are used to determine the amount of corneal compensation required for each eye The colors appearing on these images will vary greatly across the patient population The refractive correction settings and corneal measurements are saved and used for subsequent VCC ECC RNFL examinations The system will return to the ACQUISITION screen so you Can proceed to obtain compensated RNFL images GDxPRO User Manual Scanning Procedures XH Modifying the Macula Ellipse after Corneal Measurement Following a corneal measurement the MODIFY ELLIPSE MEASURING CORNEA screen appears Figure 4 12 showing how the system automatically placed the corneal measurement ellipse for each imaged eye A dotted square shows the optimal optic nerve head ONH centering which allows you to verity correct patient fixation r amp Note For accurate patient fixation ensure that the ONH is within the dotted square To ensure accurate corneal measurement the macular ellipse should be centered directly over the macula bow tie pattern
178. n Images Onl Standard deviation of the images in the mean image Should be below 8 6 2 Assess Nerve Fiber Layer Maps and Symmetry between Eyes Use the graphic elements and the Inter Eye Symmetry parameter to determine if the RNFL in one eye appears noticeably different than in the other 3 Evaluate and Compare Deviation Maps Look for groups of pixels in the inferior or superior RNFL adjacent to the optic nerve especially yellow and red squares Scattered pixels away from the ONH or located nasally or temporally often are not significant Especially look for narrow wedge defects since these may not be flagged by the summary parameters 4 Look at the NFI and RNFL I Summary Parameters If any abnormality is observed in the images check if these are confirmed by any flagged parameters While 95 of the normal population shows ECC NFI lt 35 or VCC NFI lt 30 the NFI is not always sensitive to narrow wedge defects Note The NFI is not intended to be used as the sole basis for the diagnosis of disease 5 Apply Symmetry results in context of the patient Correlate findings with those of other clinical tests or observations If determined that glaucoma or a risk of glaucoma is present follow patient with Guided Progression Analysis See Table F 1 Image Troubleshooting Guide on page F 3 for additional guidance GDxPRO User Manual Symmetry Analysis So Report Contents The following sections describe components disp
179. nd its rate of change is shown below the previous baseline s rate of change in a darker color In a simulated example see Figure 7 17 the Interior Average was progressing at 3 8 P um per year and then treated in 2003 The two data points closest to the time of treatment were selected as new baselines and the before and after regression lines were compared Instrument or Calibration Change Instrument or calibration change is indicated on the RNFL I Summary Parameter Charts by a blue asterisk at the top of the charts where a GDx instrument has changed The software only supports data across two distinct instruments each of which must have at least two visits a mean is considered one visit See Example 1 Focal Change with Data Acquired from Two Instruments on page 7 16 for an example of instrument change Nerve Fiber Layer Maps and Progression Maps The bottom of the Progression Analysis report displays maps from 3 to 8 exams chronologically trom left to right the upper row displays Nerve Fiber Layer Maps and the lower row displays image progression maps Figure 7 13 Sample courtesy of Norman S Levy MD PhD 04 13 2004 14 26 03 29 2005 12 23 04 25 2006 10 00 06 19 2007 09 55 TSS 83 TSS 63 TSS 73 TSS 76 Florida Ophthalmic Institute Q 9 QQ Q9 Q 8 Single Single Single Single B 4 _ r F J Ve De aseline Progression Map Figure 7 13 Nerve Fiber Layer Maps and Progression Maps In Figure 7 13
180. nd left eye GDxPRO User Manual Symmetry Analysis TSNIT Graph On the Symmetry Analysis report the TSNIT Temporal Superior Nasal Inferior Temporal nerve fiber layer graph Figure 6 6 displays the normal range shaded area and patient s values of RNFL developed from the measurement data obtained along the Calculation Circle The green plot displays the right eye OD and the purple plot displays the left eye OS TSNIT Graph T S N T Figure 6 6 TSNIT Graph The left side of the graph starts the plot from the Calculation Circle beginning at the temporal side of the retina As the map progresses to the right it plots the RNFL I values obtained by tracing around the Calculation Circle passing through the Temporal Superior Nasal Inferior and then back to the Temporal positions On the REVIEW CALCULATIONS screen separate left and right eye TSNIT graphs are displayed ga Note The TSNIT Graph is based only on the data points within the Calculation Circle GDxPRO User Manual Symmetry Analysis SE Deviation Map The Deviation Map Figure 6 7 shows how the patient s RNFL measurements compare with values derived from the normative database Small color coded squares indicate the amount of deviation from normal at each given location and are presented over a black and white fundus image to provide a visual frame of reference A color legend displays the comparison to normative limits see Table 6 1 Color Coding f
181. nd or lead to corrupted diagnostic or therapeutic information and may void the instrument warranty Prior to installing any printer other than one qualified by CZM please perform an external data backup Many printers come with optional software Install the required drivers only Do not install any optional software GDxPRO User Manual gt gt Printer Configuration Printer Safety Warnings WARNING To maintain patient safety an isolation transformer is required when connecting externally powered peripheral devices i e printer USB drive etc within 1 5 meters 4 9 feet from the patient In addition an isolation transformer is required for all externally powered peripheral devices outside this distance unless these devices are 1 connected to the GDxPRO using an Unshielded Twisted Pair UTP network cable CZMI recommends using a least a CAT 5 UTP network cable 2 plugged into a different power outlet than the GDxPRO and 3 qualified by CZM for use with the GDx Failure to observe this warning could result in electrical shock to the patient and or examiner WARNING To directly connect a printer to the GDxPRO only use a UTP network cable Use of a shielded network cable will ground the printer through the GDxPRO which could result in electrical shock to the patient and or examiner It could also invalidate the system safety approval WARNING Do not use the printer or the instrument with an extension cord or a power
182. ng cccecsesseecseeeseesesesseeeeees E 12 e Replacing the Face Mask ccsssscsseseccssssecsessessessessensaessensaeeas E 13 e List of User Replacement Accessories ccscceccssssessesseessrssreserees E 18 Troubleshooting F 1 Glossary uw ee G 1 SPECITICATION S iisisssssistecstepssnsnnstesssensteivisissndssnsnndsedssnnnunceaannuis H 1 Legal Notices isossa inanan anaiona ananda aidaa anaana l 1 IMOEN oisinn aaa aaa aaa J 1 GDxPRO User Manual Introduction La C1 Introduction Chapter Overview Topics covered in this chapter include Introduction to the GDxPRO page 1 1 GDxPRO User Manual page 1 3 System Hardware page 1 4 External Device Equipment page 1 8 Instrument Installation page 1 10 Tips to Avoid Damage page 1 10 GDxPRO Embedded Windows License page 1 12 Product Compliance page 1 13 User Changes to Software or Hardware page 1 13 Safety page 1 14 Electromagnetic Compatibility EMC page 1 16 Symbols and Labels page 1 20 Instrument Disposition page 1 23 Introduction to the GDxPRO The GDxPRO employs patented GDx Scanning Laser Polarimetry SLP technology to provide quantitative information about the retinal nerve fiber layer RNFL This information can be used in two levels of analysis Symmetry Analysis for comparing the right and left eye to each other and to normative data and Guided Progression Analysis for comparing the eye to itself over time Intended Use The
183. nrrnrnnensrnsrnsnnnna 5 1 e Automated Report Generation SUMMAry s sssessesseseeesrerrerrrerereen 5 1 eSelecting MeaSUureMents c ccecceseceecteceeseeeeeeeeeseeeseeeiesseeeeseeeeaes 5 1 SARO leco EN 5 4 s Manual Sele eaae r E 559 sOn Screen Exam REVIEW cess sove Unsvacethacesnesiap yea rseendasateeessrcevgnes 5 5 e Printing Exporting EXAINS siiecircess cess co sass Galeden cate eatin amenities 5 6 e Deleting MeaSureMment ccccsescsseseessesecsseesecsseeseessesseeseenereaes 5 7 Creating a Mean Measurement Manually 5 8 GDxPRO User Manual 6 Symmetry Analysis 0 se 6 1 s Chapter OVE VCW onia a 6 1 e Reviewing Measurements sessssessessresrssireriesrsrinsrnsrnnernernsrnsrenens 6 1 e Overview of the Symmetry Analysis Report s sssesseseeeseeeeeensrenn 6 3 e How to Read the Symmetry Analysis Report ccccceseeeseeeeees 6 4 SRE PONE CONTENT Sialidae a eaa is 6 5 SH CANCUN ATOM O E xen ceancrt eacptociteesn E dataadenentonencetends 6 5 AE EVN NS ear crane cate ace A E ae vd eo em rates ceo A 6 5 Nene ADETE Ma essed oi cad dea A dm dacentat aataa ty 6 7 STONIE GaP Niesen E NS 6 8 DMI el MMM d edesten e A 6 9 lt RNF ISummary Parameters Table reunirse an 6 10 e Symmetry Analysis EXAMpleS ccceceeeceeeeeeeeseeeeeeseeseieeeeeeeeees 6 12 Example 1 Severe OD RNFL KOSS 2 tes cnsescasceapiecsicdets Weeacauat ieewseastsanuars 6 12 SEXAIMPIE 2 Physiologica CUD DING eee 6 14 Example 3 S
184. ns from CZM customer service in the U S call 800 341 6968 outside the U S contact your local CZM distributor gs Note The Hard Disk Drives have a warning label Figure E 2 to guard against removal without first removing the GDxPRO from any power source Figure E 2 Hard Disk Drive Warning Label Hard Drive Replacement Procedure The following procedure describes how to remove and replace the hard drives on the GDxPRO instrument Make sure the system is powered down and the power cord is unplugged 1 If the system is running save all necessary data 2 Verify that you are on the MAIN screen and then push the power button on the Operator Console Power button on Operator Console MEDITEC a GDxPRO witnecc 6 1 OK Cancel ap i i Meditec All rights reserved WAA Mmeditec zeiss convGDePRo GDxPRO User Manual Maintenance E5 3 After the LCD turns off and the Power button changes color to amber turn off the power switch on the bottom right of the instrument and unplug the power cord next to it Power Cord Power Switch 4 Turn the drive door locking screw about 34 of a turn counter clockwise using a flat bladed screw driver to open the drive access door Drive Access Door Drive Door Locking Screw GDxPRO User Manual Maintenance 5 Turn the hard drive drawer locking screw several turns counter clockwise using a flat bladed screw driver The screw is captive and will st
185. nual for printer e Make sure that the printer settings are correct See the printer manual for information e Perform a test print What to do when an Error Message is displayed e Write down the error message received including all numbers and codes e Write down the steps that were taken to produce the error message e Follow any instructions given in the dialogue box Acquisition Mode is Suspended e f the GDxPRO is idle for an extended period of time while in any acquisition mode approximately 16 minutes the ACQUISITION SUSPENDED SCREEN Figure F 1 will be GDxPRO User Manual Troubleshooting displayed Return to where your system was prior to the suspension of acquisition by selecting OK Select Cancel to cancel the acquisition and return to the MAIN screen Acquisition Suspended Acquisition has been suspended Close this dialog box to resume acquisition OK Cancel Figure F 1 Acquisition Suspended Screen want to make sure my GDxPRO data is backed up Where is it located on the GDxPRO e For backing up data the user should use the Full Backup function System gt Database gt Full Backup Restore gt Full Backup Copying the directory will not back up the files in a format the database can recover The default data directory on the server is in ClProgram Files Carl Zeiss MeaiteclGDxPRO Databases Main Lam unable to launch the GDxPRO application e Ensure you are an Administrator or Power User in the W
186. o evidence of hemorrhage notching rim thinning exudation local RNFL injury and or asymmetry between the eyes of more than 0 2 C D ratio indicative of glaucoma or other ocular abnormalities Subjects were defined as Glaucoma Patients if they met the following criteria e Glaucomatous optic neuropathy as evidenced by optic discs that demonstrate hemorrhage notching rim thinning exudation local RNFL injury observed change in C D from prior examination and or asymmetry between the eyes of more than 0 2 C D ratio assuming no difference in disc size e Except for glaucoma no history of ocular neurological or systemic diseases that might affect the visual field GDxPRO User Manual RNFEL Normative Databases and NFI Data Collection and Review GDx Scan Selection Criteria The following scan review criteria applies to both normal and glaucoma subjects Three VCC scans were obtained per study eye The scans were then reviewed for image quality and scans having the following characteristics were excluded e Fundus images that were blurred too dark or saturated e Optic nerve head position that was too low or too high resulting in the edge of the image extending beyond the largest measurement circle radius of 59 pixels e Large eye motion during image acquisition resulting in measurement area loss of greater than 6 e Presence of floaters in the measurement area e Peripapillary atrophy in the measurement area Of the scans p
187. og button to display the DECRYPT EVENT Loc screen Figure 8 17 Decrypt Event Log To make the Event Log file readable you need to DECRYPT it You may select any Event Log file to decrypt The Event Log file must be initially created on this instrument Event Log File to Decrypt Cancel Figure 8 17 Decrypt Event Log Screen Select the Browse button in the EVENT LOG FILE TO DECRYPT field to display an OPEN dialog Figure 8 18 where you can select the Event Log File for the month you want For example the Event Log for January 2007 will be named GDxEventLog1200 7 and the file GDxPRO User Manual System Functions for December 2006 will be named GDxEventLog 122006 The current month Event Log File is selected as default Look ir B EventLog ses ey EJ GDxEventLogiZ007 log GOxEventLog122006 loq My Recent Documents m Desktop Moh File name GOsE ventLagl 2007 lo Places ere Files of type CAM Event Log Log Figure 8 18 Open Decrypt Event Log Dialog Select the Decrypt button to decrypt the file A dialog Figure 8 19 will be displayed showing the path where the decrypted text file will be located C Documents and Settings dsaniniWesktop EventLoe G0xEventLoel 200 7 log The Event Log file C Documents and Settings dsaniniiDesktop EventLog GDxEventLog1 2007 log will be decrypted into a readable text File CABDOCUMENTS ANC SETTINGS DS4NINT DESKTOP EVENTLOGGDXEVENTLOG1200
188. oing so may damage the hard drive causing it to boot into safe mode display random errors or cause the GDxPRO application to fail to launch If the software or operating system is busy you may have to wait for it to complete Hardware Power button on Operator Console 1 Press the green Power button on the Operator Console Figure 1 2 2 After the LCD turns off the Power button changes color to amber 3 Turn off the power by flipping the power switch on the bottom right of the instrument to the off position I on O off Software Log Oft Shutdown 1 To log off or shutdown through software select the Log Off button on the MAIN screen to close the application and log off the current user 2 A dialog will be displayed to confirm your intention Figure 2 2 re you sure you want bo log out the current GDx user cancel Figure 2 2 Log Out Dialog 3 Select OK to log out A Winpows Loc IN screen will be displayed GDxPRO User Manual Target Setup 4 Select Shut Down and then OK to shut down Windows 5 Atter the LCD turns off the Power button on the Operator Console changes color to amber 6 Turn off the power by flipping the power switch on the bottom right of the instrument to the off position I on O off Shut Down for Transport The Shut Down For Transport button on the MAIN Screen moves the optics to the docked position This enables the locking screw to be manually engaged and protects the optics
189. ollow up over time is needed to narrow the confidence interval 3 Apply GPA results in context of patient Combine with other clinical observations to determine if the changes indicated by GPA are clinically significant Note The three images taken on 6 12 06 could be a baseline for future analyses in Extended Mode GDxPRO User Manual Guided Progression Analysis GPA AU Name ID Exam Date Q6 12 2006 Imported DOB 08 22 1934 Exam Time 08 47 Gender Female Operator Zzkunczyn Ancestry White Physician Imported n a IM Fast Mode GDxPRO Guided Progression Analysis GPA Taune Gomeat compensation vcc ODright Image Progression Map TSNIT Progression Graph p 1 40 5 RNFL I Summary 7 T S N l T A Y Image Progression Map z i A Aj TSNIT Progression Graph y Summary Parameter Charts A Seek clinical correlates pasee P um O RNFL I Summary Parameter Charts P um TSNIT se Rate of Change P um yr Average s 07 21 2005 4 7 35 p 2 3 o ae 100 PENRI wy Sample courtesy of Average 7 Robert M Weinreb MD 60 Felipe A Medeiros MD PhD i H Hamilton Glaucoma Center i University of California San Diego Inferior Rate of Change P ym yr Average 07 21 2005 10 8 90 p 3 2 Age 7 72 7 74 75 7 TT 8 7s 80 8 Exams 1 2 3 4 5 07 21 2005 11 03 07 21 2005 11 05 06 12 2006 08 41 06 12 2006 08 45 06 12 2006 08 47 TSS 94 TSS 90 TSS 90 TSS 87 TSS 87 Q 8 ag ag ag ag Single Single
190. ompensation e VCC Method Scans with compensation residual magnitude gt 12 nm were not included in the normative database A VCC scan with a residual gt 12 nm should be interpreted with caution e ECC Method Corneal compensation residual magnitude usually does not exceed 4 nm A scan with a residual gt 4 nm should be interpreted with caution RNFL Analysis Tools e Age adjusted normals with diverse ancestry e Machine learning classifier known as the NFI for SLP RNFL measurement e GPA GDxPRO User Manual Specifications am Computer Windows XP Professional Operating System Service Pack 3 Pentium IV or equivalent 2 2 Ghz RAM gt 512 MB Two hard disk drives to support data redundancy gt 80 GB each Internal exam storage Up to 35 000 exams Writable Optical Drive 1 Ethernet ports 4 USB 2 0 ports Integrated 8 4 TFT LCD color flat panel touch screen display 18 bit color 800 x 600 resolution brightness gt 220 nits DVI I Video port Supports 24 bit color at 800 x 600 resolution Printer support Standard printers and wireless printers via USB and or Ethernet port Physical e Dimensions instrument only 63 5 L x 30 5 W x 40 6 H cm e Dimensions in crate 77 Lx 55 W x 80 H cm e Weight instrument only 22 5 kg 50 Ibs e Weight in crate 31 kg 69 Ibs Electrical Requirements Electrical Rating e 100 240 V 50 60 Hz Power Rating e 200 VA Fuse Rating e T5A 250V WARNING Always replace
191. ompensation obtain a new measurement for the corneal contribution or you may choose to remeasure the corneal contribution to reestablish or update its value for example following cataract or refractive surgery prior to a new RNFL exam Select Reset Compensation on an RNFL Acquisition screen Figure 4 10 or Figure 4 11 and the ACQUISITION MEASURING CORNEA screen appears Refer to the Scanning Procedure section on page 4 3 to remeasure the cornea When satisfied with the image quality on the IMAGE CHECK screen select Accept or OK to go to the REVIEW CALCULATIONS screen Figure 4 27 GDxPRO User Manual Scanning Procedures EEE Final Step Saving the Scans At the end of exam acquisition the REviEw CALCULATIONS screen Figure 4 27 provides an abbreviated summary of the exam results including the TSNIT Graph nerve fiber layer map and parameter table See 6 Symmetry Analysis for a discussion of the REVIEW CALCULATIONS screen and the Symmetry Analysis report Review Calculations ECC OD 172072009 17207 2009 os Right Eye TSNIT Parameters OD Yalue OS Yalue TSNIT Average s i Comparison to Normative Limits Superior Average Cancel Inferior Average TSNIT Standard Deviation Inter Eye Symmetry o Nerve Fiber Indicator 21 The NFI is not intended to be used as the sole basis of diagnosis for disease Print amp Export Preview Export Options save Only Figure 4 27 Review Calculations Screen End of Exa
192. on at the MAIN screen select System gt Database gt Recalculate Data Select OK on the Recalculate Data dialog Figure 8 6 A Press OK to recalculate all data in the database cane Figure 8 6 Recalculate Data Dialog GDxPRO User Manual System Functions A PROGRESS STATUS screen will be displayed Figure 8 7 Progress Status Please Wait Until Data Processing Ils Complete Number of Items Recalculated 0 Number of Items Processed 0 Cancel Figure 8 7 Recalculate Data Progress Status Screen When the Recalculate Data function is complete a dialog will be displayed Figure 8 8 A Recalculate Complete Number of Items Processed 0 Number of Items in Database Figure 8 8 Recalculate Data Complete Dialog GDxPRO User Manual System Functions oa Importing and Exporting Data You can connect a GDxPRO directly to a Windows PC or network server via the Ethernet network card in your PC Alternatively if you have a local area network LAN in your office you can attach a GDxPRO to the LAN allowing it to communicate with any of the networked Windows PCs or printers within your clinic Using either of these methods you can import and export raw measurement data without formatting There are several reasons that you might want to perform data imports and exports For example you can export measurement data to a PC in order to back up the data Later the data can be imported again possibly to a diffe
193. one Windows User Account do not use Fast User Switching an option of the Windows operating system to switch between User Accounts while GDxPRO application is active When the GDxPRO is first started while logged in as an administrator a default operator will automatically be created from your logged in administrator account The GDxPRO database contains operators doctors patients and exams measurements or images Only an operator will be able to view exams and access patient records for those patients that are assigned to a doctor associated with the operator Operators can be associated with one or more doctors Doctors associated with patients defined on the PATIENT INFORMATION screen are called Primary or Referring Doctors see Patient Information Screen on page 3 8 Doctors associated with exams at exam acquisition time or mean creation are called Exam or Attenaing Doctors see Figure 4 28 and are displayed on the MEASUREMENT LIST SCREEN Figure 5 1 GDxPRO User Manual Setup 77m To create an operator select the Set Up Operator button on the MAIN screen The SET UP OPERATOR screen Figure 2 6 is displayed Setup Operator The Current Log On User Domain CARL 10636 User dsanini A valid operator must be added to the system to enable log on and maintain doctor and patient security Cancel Add Modify Add Modify Operator Doctor Figure 2 6 Set Up Operator Screen GDxPRO User Manual Setup Add
194. or Likely progression RNFL decrease that has been confirmed by a consecutive follow up examination Macula A small approximately 3 area of the retina that provides a patient s central vision This area surrounds and includes the fovea Megabyte A unit of computer storage equal to either 1 000 000 bytes or 1 048 576 bytes depending on context 1 000 kilobytes is equal to 1 megabyte A mean is an image created by averaging two to three ECC or VCC measurements of the same eye acquired on the same instrument within thirty days of each other GDxPRO User Manual Glossary Measurement The set of results obtained as a result of performing a scan of a patient s eye There is one eye per measurement The set includes the Nerve Fiber Layer Map the fundus image and ellipse position and the diagnostic parameters derived from the Nerve Fiber Layer Map Micrometer A micrometer symbol um is a unit of length in the metric system equal to one millionth of a meter i e 10 m or one thousandth of a millimeter Nanometer A nanometer symbol nm is a unit of length in the metric system equal to one billionth of a meter i e 10 m or one thousandth of a micrometer Nerve Fiber Layer Map An image presenting color coded RNFL measurements generated from the 32 scans acquired during an exam The Nerve Fiber Indicator NFI for GDx is an artificial intelligence algorithm that analyzes the entire RNFL profile It is
195. or calibration values Select System gt Export Error Log to display a Browse for Folder dialog Figure 8 16 Browse for Folder Select Export folder Desktop E3 GB My Documents F My Computer H OS Cs See Daka De fae DAT AZ Es GJ DYDICO RW Drive Gs Sg Local Disk i E Shared Documents E Zeiss s Documents t3 My Network Places Cancel Figure 8 16 Export Error Log Dialog Select the export folder you want and then select OK The error log files will be saved to this folder GDxPRO User Manual System Functions CAEN Event Log File A log records user events tor GDxPRO for all operators such as deleting adding merging or modifying patient data and the operator performing the event The Event Log File can be used for security troubleshooting or as an audit trail The following events are logged Log in Log out New Update Delete Patient New Update Delete Measurement Export Import Data Optimize Database Merge from MSDE GDxPRO Fox Pro GDxVCC Backup Database Merge Single Patients An encrypted Event Log File is created each month To make the file readable you need to decrypt it into a readable text file Only a user logged in as an administrator can decrypt the Event Log Also to decrypt the selected Event Log must have been created on the current instrument or computer To select an Event Log File select the System button trom the MAIN screen and then select the Decrypt EventL
196. or Deviation Map on page 6 9 Figure 6 7 Deviation Map Table 6 1 Color Coding for Deviation Map Color Comparison to Description Normative Limits Red lt 0 5 Indicates a value less than the lower 0 5 limit of the normal study population Dark Blue lt 5 Indicates a value less than the lower 5 limit of the normal study population No Square gt 5 Indicates a value greater than or equal to the lower 5 limit of the normal study population GDxPRO User Manual Symmetry Analysis RNFL Summary Parameters Table The RNFL I Summary Parameters table Figure 6 8 presents parameters computed from the Calculation Circle the NFI also includes data outside the Calculation Circle and compared to similarly computed values trom the normative database Values are color coded to indicate deviation from normal as in the Deviation Map Table 6 1 Color Coding for Deviation Map O 5 go Actual Val TSNIT Average 63 0 Superior Average 73 0 Inferior Average 11 6 TSNIT Std Dev 286 Inter Eye Symmetry NFI Figure 6 8 RNFL I Summary Parameters Table ga Note The RNFL I Summary Parameters especially NFI were determined to be the most effective in helping doctors differentiate glaucoma patients from normal patients These values should be evaluated together and in conjunction with all other clinical information for the patient The RNFL Summary Parameters table is populated by t
197. ou to change the Doctor Clinic field with any doctor that is associated with the current operator This doctor is called the Exam or Attending doctorand is displayed on the MEASUREMENT LIST SCREEN The Exam doctor called the Primary or Referring doctor can be different trom the doctor associated with the patient and defined on the PATIENT INFORMATION screen Figure 3 7 You may also add any comments in reference to the mean in the Comment field Text entered in the Comment field is displayed below the measurements list on the MEASUREMENT LIST SCREEN when the mean measurement is selected see Figure 5 13 but is not displayed in any report The Operator will default to the currently logged in user You can edit the Operator field if desired Operator Information Operator dsanini Doctor Clinic Dr Oppenheimer Hacienda Clinic Comment Optional Cancel Figure 5 12 Operator Information Screen GDxPRO User Manual Managing Measurements ENNE Select OK to continue to save the mean measurement The MEASUREMENT LIST screen will now display the mean measurement Figure 5 13 The Mode field for the mean will indicate that the measurement is a mean The Eye icon for a mean created from two or three measurements will be colored blue however means created trom two measurements will have a small 2 subscript in the icon The measurements used to create the mean will have a small M in the green Eye icon see Table 5 1 Imag
198. ox using the screwdriver and instructions provided in the accessory kit See Unlocking the System on page 2 2 Note Be sure to remove the objective lens foam block protector and unlock the scan head optics before applying power to GDxPRO System warm up and self tests will fail if the scan head optics are not unlocked with power applied 7 Read and remove the Caution label from the LCD Display GDxPRO User Manual Setup 8 Connect the female end of the power cord into the power cord connector on the bottom right side of the GDxPRO Figure 1 6 Plug the power cord male end into a power outlet Unlocking the System If the Shut Down For Transport procedure see Transporting on page E 9 was performed the last time the system was powered down or if it is unknown the procedure for unlocking the optics box should be performed as a precaution before powering up the system Insert the Phillips screwdriver included in the GDxPRO accessory kit into the optics lock down screw hole the large hole on the right side of the unit Figure 2 1 engage the spring loaded screw and turn the screw counterclockwise to ensure that it is loosened and moves freely This will ensure that the optics box is unlocked and it is safe to power up the system Figure 2 1 Unlocking the Optics Box Powering Up the Instrument Note If the optics box is locked and the instrument is turned on a message will be displayed to unlock it before you can power up
199. page 2 4 GDxPRO User Manual System Functions Remote Support Selecting the System gt Remote Support button will open the Carl Zeiss Meditec Live Remote Assistance web page Figure 8 29 if your GDxPRO is connected to the internet through a network connection With Live Remote Assistance a Carl Zeiss Meditec Technical Support technician can view your GDxPRO Windows desktop and share control of your mouse and keyboard to help solve a technical problem For assistance call Carl Zeiss Meditec customer service In the U S call 800 341 6968 Outside the U S contact your local CZM distributor FAAKWY CARL ZEISS MEDITEC Live Remote Assistance Do you need a quick solution to a technical problem With our live remote assistance tool a member of our support team can view your desktop and share control of your mouse and keyboard to get you on your way to a solution How to Get Support A member of our support team will talk with you first to determine the nature of the problem You will find the answers to security questions and system configuration requirements on our FAQ page You can also view a demonstration of a screen sharing session How It Works Step 1 Once you are on the phone with a member of our support team you will be directed back to this page after your support representative provides you with a unique connection code You will then enter the code in the field below and click the Click Here button to initiat
200. pertension dementia or multiple sclerosis Life threatening or debilitating disease Inclusion Criteria for Glaucoma Subjects Males or females 18 years of age or older Glaucomatous Visual Field abnormality in either eye Diagnosis of glaucoma Exclusion Criteria for Glaucoma Subjects Best corrected visual acuity less than 20 40 Refractive error outside 10 00D to 5 00D range Previous laser and incisional surgery Evidence of a visual field abnormality consistent with disease other than glaucoma Evidence of diabetic retinopathy macular degeneration or other vitreo retinal disease History of diabetes leukemia AIDS uncontrolled systemic hypertension dementia or multiple sclerosis Life threatening or debilitating disease Normal and glaucoma subjects were defined by Principal Investigators at each site by reviewing clinical and visual field data considering inclusion and exclusion criteria The GDx instrument was not used in the diagnosis of subjects Furthermore GDx data was not used to include or exclude any subjects from either normal or glaucoma groups 1 Previous uncomplicated cataract surgery in the study eye more than one year prior to enrollment is acceptable GDxPRO User Manual RNFL Normative Databases and NFI ae The subjects were defined as Normal if they met the following criteria e Best corrected visual acuity of 20 40 or better in both eyes e IOP less or equal 21 mm Hg e No history of ocular neurological
201. placed with the specified backup database After the restore process is complete you will be prompted to reboot GDx Do you want to continue with the restore process No Figure 8 13 Restore Database Warning Select Yes to begin the database restore or No to cancel If you select Yes the GDxPRO application will close Restart the GDxPRO application or reboot the GDxPRO instrument to use the restored database GDxPRO User Manual System Functions AEE Disk Backup Options The system saves data to both a primary and a backup hard disk drive for data safety If one of the hard drives fails it will need to be replaced WARNING Only disable disk backups when instructed by CZMI This option may cause adverse side effects To turn the Backup Options off at the MAIN screen select System gt Backup Options gt Turn Backups Off to display the BACKUP OPTIONS screen Figure 8 14 Backup Options The System must save patient data for it to be used later for review comparisons etc The System saves data to two hard drives to make sure the data is saved If one of the hard drives fails itis necessary to replace it If this is the case the system can still be used but backups must be turned off Then once the drive is replaced backups should be turned on again Contact CZM Service if you have questions Cancel EE a Turn Backups Off Figure 8 14 Backup Options Screen The system will display a warning dialo
202. ponding report in PDF format or a TIFF or JPEG image format See Setting the Preview Export Image Type on page 2 16 to set the image type Use the Report Menu to select which reports to print then select Print Report s to print them to the current default printer You can also select Export Report s to export these selected report s to the default export path see Default Import Export Path optional on page 2 10 See Setting the Preview Export Image Type on page 2 16 to set the export image type Select Yes to use the default export folder or select No to display a Browse for Folder dialog where you can select the export folder you want to use Select Symmetry Analysis to display the REVIEW CALCULATIONS screen see 6 Symmetry Analysis GDxPRO User Manual Guided Progression Analysis GPA A Reference Images Baselines and Excluded Measurements To set baselines and reference images and to exclude measurements select the More button on the MEASUREMENT LIST screen The MEASUREMENT List screen Figure 7 3 with additional buttons is displayed Measurement List Full A GPA Progression Analysis report can be generated by selecting three to eight visits of Baseline measurements the SAME type and selecting Print Export Review Operator dsanini identified as B2 and B1 Patient Joseph Steffani Patient ID 443434 Device 0143FBD70700003A Primary Doctor Clinic Dr Jones Hacienda Clinic RS 5 28 2002 11 90AM V
203. ported Variable Corneal Compensation VCC TSNIT Average Superior Average Q 9 TSS 76 Residual 8nm Single Scan 02 12 2008 09 44 Inferior Average TSNIT Std Dev T TSNIT Graph eTrded to be used as the sole basis of diagnosis for disease 0 P um GDx technology assesses RNFL health by measuring RNFL Integrity RNFL I derived from RNFL thickness and structural organization and expressed in units of Polarimetric Micrometers P um Physician Interpretation Physician Signature GDxPRO Sample courtesy of Joseph Sowka OD FAAO Professor and Director of Glaucoma Services Nova Southeastern University College of Optometry Ft Lauderdale Figure 6 2 Sample Symmetry Analysis Report Abnormal OD and Normal OS GDxPRO User Manual Symmetry Analysis How to Read the Symmetry Analysis Report 1 Verify data quality The Calculation Circles should be centered on the optic nerve The image should be evenly illuminated and in focus Q Quality Score Indication of image quality Scores of 7 or higher are considered to be of good quality while scores less than 7 should be interpreted with caution TSS Typical Scan Score Measures the amount of artifact in the image Using ECC scores should be gt 40 and using VCC scores should be gt 60 Residual Measures the error in corneal compensation Scores should be lt 4 ECC and lt 12 VCC SD Mea
204. ports both digital and analog transfers so it works with both digital and traditional monitors DVI D stands for DVI Digital and supports digital transfers only ECC Enhanced Corneal Compensation The use of a variable retarder and software compensation to cancel a particular patient s corneal birefringence In this mode a special corneal measurement exam is performed at the patient s first visit similar to the one in VCC The results in the macular region of this exam are analyzed to determine the optimal bias birefringence that is superimposed onto the RNFL birefringence This total birefringence form the bias and corneal birefringence which is then removed mathematically by the software to yield the RNFL measurement ECC images can be acquired and reviewed on the GDxPRO GDxPRO User Manual Glossary a EMR Electronic Medical Records See PMS Ethernet Ethernet is a family of standard computer networking technologies for local area networks LANs Allows you to network your GDxPRO instrument with different computers printers or office management systems to share information and exams Export Process of copying exams from the GDxPRO instrument s hard drive Extended Mode Progression Analysis mode using na vidua measurement variability This mode requires means of three measurements Fast Mode Progression Analysis mode which compares change to the pre determined average measurement variability derived trom a samp
205. positioning the patient Seat the patient in front of the system as shown in Figure 4 3 Adjust the table or patient chair to allow the patient to lean forward and place his her face comfortably into the face mask Make sure that the patient s forehead and cheeks are centered gently and evenly touching the mask and the patient is comfortable To help find proper eye positioning align the eyes the corner of the eye or the canthus with the eye level indicators on the face mask see Figure 4 4 The patient should be comfortably seated so that their head remains stationary head movement interferes with the quality of the acquired image Face mask Eye level indicator canthus mark Figure 4 3 Positioning the Patient GDxPRO User Manual Eye level indicator canthus mark Click images above to see animation Standard Low Vision Target Target Scanning Procedures Eye level indicator canthus mark Figure 4 4 Eye Level Indicators on Face Mask Step 2 Selecting Patient Fixation With the patient in position instruct him her that he she will see a field of thin red horizontal lines A fixation target is located on one side of the field For the right eye the target will be on the left side of the red field for the lett eye it will be on the right side The GDxPRO features two different fixation targets Standard and Low Vision as described below Ask the patient to keep his her gaze fixed at the fixation tar
206. printers and downloads of printer drivers or call Carl Zeiss Meditec customer service In the U S call 800 341 6968 Outside the U S contact your local CZM distributor Note Consult your network administrator or information technology IT professional to make sure you install and configure the print driver correctly Specific characteristics of individual network configurations can vary greatly USB Configuration No printer configuration is required for the USB configuration Three general steps are required for configuration install printer drivers on the GDxPRO if required connect the printer to the GDxPRO via USB and power on the printer GDxPRO User Manual Data Transfer Using Optical Disks 3 cD Data Transfer Using Optical Disks Overview You can transfer data between GDxPRO instruments with an optical drive and Roxio Drag to Disc software installed This appendix explains the features and limitations of GDx data transfer using optical disks and provides instructions for data transfer Important Note The Roxio Drag to Disc software is pre installed on the GDxPRO instrument and specially configured for use with it Do not re install Roxio Drag to Disc on the instrument The Roxio Easy Media Creator CD included with your instrument is provided to satisfy licensing requirements only Compatible Media Formats The GDxPRO instrument can use the following types of disks to transfer data e CD R writable CD e C
207. ptimize Database 8 3 GDxPRO User Manual P Patient Console 1 6 Patient Fixation 4 6 Patient ID 3 2 Patient Identification 3 1 3 4 Patient Information Screen 3 8 4 2 Patient Lens 1 6 Patients Deleting 3 8 Editing Patient Information 3 8 Entering New Patient 3 1 Merging 3 10 Patient ID 3 2 Searching 3 6 Selecting 3 7 Selecting Existing Patients 3 5 Patients List 4 2 PDF 2 16 PDF Manual 1 4 Phototoxicity Statement 1 16 Physical Characteristics H 3 Polarimetric Thickness 1 3 Ports 1 7 1 8 Positioning the Patient 4 5 Power Button 1 5 Power Cord Connector 1 7 Power Problem E 1 Power Switch 1 7 Powering Down 2 3 Powering Up 2 2 Preview Button 7 4 Primary Doctors 2 6 Print amp Export Options 5 1 5 6 6 2 Printer Configuration C Printer Setup 8 2 Printers Configuration C 1 Network Configuration C 3 Safety Warnings C 2 USB Configuration C 4 Printing Exams 5 6 Printing Reports 5 4 6 2 7 4 Product Compliance 1 13 Product Labels 1 22 Product Safety 1 14 Progression Analysis 7 2 Progression Analysis Report 7 1 Screen 5 5 7 4 Progression Maps 7 14 Protective Packing Symbols 1 21 Pupil Dilation 4 9 P Value 7 13 Q Q Value 4 31 5 9 6 5 7 15 Quality Parameters 4 13 Quality Score 4 31 5 9 6 5 7 15 R Rate of Change 7 13 Raw Data Automatic Export 2 16 Exporting 5 6 Recalculate Data 8 5 Recommendations 1 12 Record Management 3 1 5 1 6 1 Reference Image 7 5 Changing 7 6 Setting 7 5 Referring
208. quipment recycling requirements References Huang XR Knighton RW Microtubules contribute to the birefringence of the retinal nerve fiber layer nvest Ophthalmol Vis Sc 2005 46 12 4588 4593 Fortune B Wang L Cull G Cioffi GA Intravitreal colchicine causes decreased RNFL birefringence without altering RNFL thickness nvest Ophthalmol Vis Sc 2008 49 1 255 261 Dreher AW Reiter K and Weinreb RN Spatially resolved birefringence of the retinal nerve fiber layer assessed with a retinal laser elliosometer Aoo Opt 1992 31 3730 3735 4 Huang X R Bagga H Greenfield DS and Knighton RW Variation of peripapillary retinal nerve fiber layer birefringence in normal human subjects nvest Ophthalmol Vis Sci 2004 45 3073 3080 Fortune B Cull GA and Burgoyne CF Relative course of retinal nerve fiber layer RNFL birefringence RNFL thickness and retinal function changes after optic nerve transaction nvest Ophthalmol Vis Sc 2008 49 4444 4452 6 Zaveri MS Conger A Salter A Fronman TC et al Retinal imaging by laser polarimetry and optical coherence tomography evidence of axonal degeneration in multiple sclerosis Arch Neurol 2008 Jul 65 7 924 8 NO UJ On GDxPRO User Manual Introduction GDxPRO User Manual 2 Setup Chapter Overview This chapter explains how to set up and use the GDxPRO instrument Topics include e Instrument Setup page 2 1 e Operating the Touch Screen page
209. r Triple Scan 1 You can select Refraction to change the patient s refraction Reset Compensation to reset corneal compensation and Other Eye to scan the other eye Refraction and Reset Compensation are not available for subsequent scans in the Triple Scan process oa Note The imaging mode ECC or VCC cannot be switched once the first RNFL exam of the Triple Scan sequence is acquired o gt Note Triple Scan acquisition may be cancelled during any part of the acquisition process Images acquired are saved once the user accepts the image quality on the IMAGE CHECK screen during the Triple Scan sequence even if the triple scanning is cancelled ga Note Patients whose last exam was acquired on a different instrument will be prompted to acquire one additional Triple Scan image GDxPRO User Manual Scanning Procedures 2 Acquire the first RNFL scan as outlined in Scanning Procedure starting on page 4 3 The IMAGE CHECK screen is displayed giving you the opportunity to modify the image retake image s or accept the scan s When you select Accept or OK the second Triple Scan ACQUISITION screen is displayed Figure 4 32 Acquisition ECC Triple Scan 2 icity ower FART peu Retraction Auto Age Range 40 49 Ancestry Eastern Restart Low Vision Figure 4 32 Acquisition Screen for Triple Scan 2 This same process is used to acquire subsequent scans You can acquire up to five scans in one Triple Scan acquisition pro
210. r diagnosis Infants aphakes and persons with diseased eyes will be at greater risk The risk may also be increased if the person being examined has had any exposure with the same instrument or any other ophthalmic instrument using a visible light source during the previous 24 hours This will apply particularly if the eye has been exposed to retinal photography Note The fundus illumination brightness of the GDxPRO is not adjustable It is factory set to a level that optimizes the exam efficacy and minimizes light exposure to the subject Note The GDxPRO uses visible and infrared light to measure properties of the retinal nerve fiber layer and uses no ultraviolet light lt 400 nm Ultraviolet protection by the use of filters or other optical apparatus is neither required or approved Electromagnetic Compatibility EMC e EN 60601 1 2 2001 Note The GDxPRO needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided herein Note Portable and mobile RF communications equipment can affect medical electrical equipment WARNING The use of accessories transducers and cables other than those specified may result in increased emissions or decreased immunity of the equipment WARNING The GDxPRO should not be used adjacent to or stacked with other equipment GDxPRO User Manual Introduction 117 Guidance and manufacturer s declaration electromagnetic emissions
211. r instrument variability the sensitivity of GPA may be lower due to increased total test retest variability GDxPRO User Manual Guided Progression Analysis GPA Fast and Extended GPA Modes Progression Analysis has two modes as compared in Table 7 1 Fast and Extended Modes shown below Table 7 1 Fast and Extended Modes Fast Mode Extended Mode Includes Single measurements Requires Means of three measurements facilitated with Triple Scan Compares change to the pre determined Calculates the na vidua measurement average measurement variability derived variability of each eye for a selected from a sample population patient Supports both ECC and VCC images Supports both ECC and VCC images Can be used for follow ups of non critical Requires more time but is more patients when there is no time to acquire sensitive Highly recommended for Triple Scans critical patients Note For optimal performance use of Extended Mode is encouraged Note We recommend acquiring baselines spaced 2 to 3 months apart for best results Acquiring Triple Scan baselines provide the option of using Fast Mode or Extended Mode for follow ups There could be patients for whom Fast Mode reports change but Extended Mode does not This may occur if a patient s individual measurement variability is higher than the test retest variability that GPA assumes for the general population However in such a case there would be an increa
212. r time some patients require new corneal measurements in order to maintain image quality This should be done whenever the need arises see Remeasuring the Corneal Compensation Image on page 4 24 GDxPRO User Manual Guided Progression Analysis GPA Overview of the GPA Report Name ID Exam Date 06 12 2006 Imported DOB 08 22 1934 Exam Time 08 47 Gender Female Operator zkunezyn Ancestry White Physician Imported m m MW Fast Mod GDxPRO Guided Progression Analysis GPA variable Comeat compensation VCC ODright Color Coded RNFL Summary Box S N r Indicates evidence of v __ tls abi gaat ate NN sA bs Ay ie rv Na TSNIT Progression Graph i A Statistically significa nt change i Summary Parameter Charts 9 e No Progression FM as E Possible Progression TSIT 4 j Rate of Change P um yr Average i 07 21 2005 4 7 35 p 2 3 D Likely Progression S SS ee Possible Increase TSNIT Progression Graph Superior Image Proaression Ma Most sensitive to narrow focal change Rate of Change P um yr Inferior A 07 21 2005 10 8 9 0 p 3 2 verage TSNIT Progression Graph Most sensitive to broader focal ee change aa RNFL I Summary Parameter Exams 1 2 3 a 5 o 07 21 2005 11 03 07 21 2005 11 05 06 12 2006 08 41 06 12 2006 08 45 06 12 2006 08 47 TSS 94 TSS 90 TSS 90 TSS 87 TSS 87 Charts T Q 8 Q 9 29 Q 9 Q 9 Single Single Single
213. re of the spread of its values It is defined as the square root of the variance Variance is the average of the squared differences between data points and the mean Variance is tabulated in units squared Standard deviation being the square root of that quantity therefore measures the spread of data about the mean measured in the same units as the data Stated more formally the standard deviation is the root mean square RMS deviation of values from their arithmetic mean TFT Thin Film Transistor TFT is a special kind of field effect transistor whose primary application is in liquid crystal displays LCDs Transistors are embedded within the panel itself reducing crosstalk between pixels and improving image stability TIFF Tagged Image File Format an image file format for storing images Unlike standard JPEG TIFF files using lossless compression or no compression at all can be edited and resaved without suffering a compression loss or image quality degradation Storing a sequence of images in a single TIFF file is also possible Triple Scan An option on the Patient Information Screen which allows you to acquire three images of the same eye or both eyes at one time This facilitates mean creation tor Extended Mode TSNIT The regions around the optic disc Temporal Superior Nasal Inferior Temporal TSS Typical Scan Score TSS is a measure of the typicality of the RNFL image TSS ranges from O very atypical to 100
214. red during transportation either in office or out of office moves If there is any chance of the GDxPRO being bumped or jarred perform the Shut Down for Transport procedure It is mandatory for out of office transportation This Shut Down For Transport procedure moves the optics to the docked position This enables the locking screw to be engaged and protects the optics from damage during transportation At the MAIN screen select Shut Down for Transport The GDxPRO will display a message asking you to contirm that you wish to shut the system down Figure E 3 Prepare for Transport dd Attention This function will prepare the instrument for transport To resume normal operation following this process you will need to power down the instrument using the Power button located on the Operator Console Are you sure you want to proceed with the transport process cnet Figure E 3 Shut Down for Transport Dialog Press Cancel if you do not want to shut the system down Press OK if you do want to shut down the system If you select OK the GDxPRO internal optics will start moving towards its home position and the PREPARE FOR TRANSPORT screen will be displayed Figure E 4 es lt lt lt The optics have been moved to the docked position gt gt gt Prepare for Transport If you plan to transport the instrument the locking screw should be Cancel engaged as shown above This process when performed properly helps protect the opt
215. rement Measurement Measurement Measurement Measurement 0008 0008 0008 0008 0008 0008 0008 0008 0008 0008 0008 0008 26 0 Login 0001 000 000 000 dsanini Pas saf 28 25 28 28 eal 31 sal 4c l e he fl 730 30 43 30 Update Measurement 0008 OD GDX_ACCESS 43 34 Update Measurement 0008 OD GDX_ACCESS 43 38 Update Measurement 0008 OD GDX_ACCESS 743 43 Update Measurement 0008 OD GDX_ACCESS 3 5 Logout 0002 000 000 000 dsanini dsanini GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS GDX_ACCESS 0002 000 000 000 dsanini HH THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS THICKNESS 28 2002 11 33 05 AM 5 28 2002 11 37 26 Am 28 2003 11 11 13 AM 5 28 2003 11 19 42 AM 5 28 2003 11 23 08 AM dsanini dsanini dsanini dsanini dsanini 11 17 2003 11 42 49 am dsanini 6 1 2004 11 6 1 2004 11 6 1 2004 11 6 29 2005 8 6 29 2005 8 6 29 2005 8 1 Update Measurement 0008 OS GDX_ACCESS THICKNESS 8
216. rent GDxPRO instrument This might be useful in a practice where doctors perform exams on multiple instruments since this allows patient data to be easily transterred trom one GDxPRO to another as needed You can even place the exported data on removable media such as USB flash disk or optical disk see D Data Transfer Using Optical Disks and transport it to another clinic where it can be imported trom a networked PC to any GDxPRO instrument at that clinic In this way doctors who see the same patients at different clinics can easily transfer data from clinic to clinic Note For GPA analysis it is not recommended to perform scans for the same patient on different instruments For exporting and individual patient information see Printing Exporting Exams on page 5 6 To use the database importing and exporting features see Export Data and Import Data below Export Data The Export Data function exports all information required to regenerate the database To perform the Export Data operation at the MAIN screen select System gt Database gt Export Data A Browse for Folder dialog will open where you can select the folder for the data export Selecting the optical disk drive will initialize burning of a CD DVD Import Data Selecting Import Data imports data into the current systems database Importing only imports updated or new database records All calculation records are recalculated prior to saving into the database To perform th
217. rently you must use a switch The switch may be directly connected to the instrument or elsewhere on the local area network Contiguration in this scenario is the user s responsibility GDxPRO User Manual Network Storage Device Configuration 23 Installing and Configuring the NAS Device You can attach the NAS device directly to the GDxPRO Ethernet port or you can connect it via your office network local area network or LAN These instructions apply to both scenarios 1 With the GDxPRO and the NAS device turned off use a network patch cord to connect the NAS device either directly to the GDxPRO or to the office network local area network or LAN on which the GDxPRO resides Refer to the manufacturer s instructions for details regarding installation of the NAS device r amp Note For safety observe the warnings and requirements on page B 2 that relate to the type and length of cord 2 Turn on the NAS device and wait for initialization to complete before you turn on the GDxPRO Often a color change in a light on the front of the NAS device indicates initialization is complete but see the manufacturer s instructions for details on initialization Turn on the GDxPRO After you complete the startup process select the Windows key amp on the keyboard to see the Windows Task Bar UI In the system tray at lower right you may observe a Local Area Connection notice resulting from attachment of the NAS device Ignore the mess
218. return to the MAIN screen automatically Database The databases were optimized successfully Cancel Figure 8 4 Database Optimize Screen Merge The Merge function is used to transfer data trom a GDxVCC or GDxPRO to another system Merge will merge the database files from a user specified location source to the main drive destination All records are consolidated from the two databases into one database This operation is available to any user with administrative privileges The merge can support any database version as long as the data on the master drive is newer or the same version than the database being merged to GDxPRO User Manual System Functions oa To perform the Merge operation at the MAIN screen select System gt Database gt Merge Browse to the location where the database to be merged is located and then select the OK button Merge database To merge a GDx CC Access FoxPro database into the existing GDxData SQL databsse specify the folder where the FoxPro DBF CDX data files are located Database Folder Cancel Figure 8 5 Database Merge Screen Recalculate Data Performing the Recalculate Data function will update all records in the database with the most current version of calculations This function may be performed after a software update and may take a while depending on the number of records in the database This process can be cancelled at anytime To pertorm the Recalculate Data operati
219. rform an import or export operation See the Set Up Operator Screen on page 2 7 for the current operator Note We strongly recommend that operators routinely log out to secure the instrument and protect patient data privacy Associating Dissociating Doctor Note After importing data from a GDx instrument all imported doctors will be automatically associated with the current operator In the To be associated with Doctor field select a doctor or All Doctors to assign all doctors from the GDxPRO database from the drop down menu and then select the Associate Dissociate Doctor button to display the Create Association dialog Figure 2 10 Create Association Operator C4RL 10636 dsanini will be associated with Doctor Dr Oppenheimer Figure 2 10 Create Association Screen Select OK to associate the doctor s with the operator The OPERATOR INFORMATION screen will be updated to reflect the association the doctor s will be displayed in the GDxPRO User Manual Associated doctors Setup 73m Associated with field as shown in the following OPERATOR INFORMATION screen Figure 2 11 Operator Information A valid system user account must be added to the system prior to adding Operator information To view or add system account information select View Create System User Accounts View Create System User Account Operator Associated with dsanini Dr Dublin Dr Oppenheimer Domain CARL 10636 l User dsan
220. robability value widely used to indicate where a particular value lies in a normal distribution It is expressed as a percent Quality Score Image Quality Score Q is measure of image quality ranging from 1 low to 10 high A good image has a score of 7 or higher RAM Random Access Memory Fast access memory that is cleared when the computer is powered down GDxPRO User Manual Glossary Reference image A single measurement used as the reference to which all other measurements of the same eye are aligned Required for mean creation and progression analysis Refraction setting The refraction setting entered for each eye is actually the spherical equivalent of the patient s residual refractive error Residual means that if the patient is wearing contacts the correction provided by the contact lens should not be included in the entered retraction Further if the prescription is for bifocals the far correction should be used Retina The part of the eye that converts optical images into nerve pulses that are sent to the brain Composed of a thin layer of tissue that lines the interior surface of the rear two thirds of the eyeball Contains the rods and cones and the interconnecting nerve fibers RNFL I The measurement of the phase shift that occurs when polarized light passes through the RNFL Light polarized parallel to RNFL micro structures travels more slowly than light polarized perpendicular to them The
221. rrors have been detected in your system Acquisition will be disabled Call Carl Zeiss Meditec s Service Department for further instruction Description 18053 Image acquisition failed an image was not acquired We Cancel Export Test Previous scroll Left scroll Right Results Figure 8 24 System Error List screen Continuous Test If you suspect that your system is intermittently demonstrating a problem it is recommended to run the Continuous System Test for a period commensurate with the period between suspected problem occurrences Continuously passing the system test over that suspect period indicates that the system operation is stable GDxPRO User Manual System Functions To run the System Test continuously at the System Test screen select Continuous Figure 8 25 Test Iterations Enter the number of iterations to run the system test continuously T Figure 8 25 Continuous Test Screen GDxPRO User Manual System Functions 97 Enter the number of iterations you want to run the system test Entering 0 will run the system test continuously until the user cancels the test Select OK to begin the test A test progress screen will be displayed Figure 8 26 Progress Of System Test Test Status Test Count 1 Image Taking Test Error Count Progress ona Cancel Figure 8 26 Continuous Test Progress Screen Once the test ends errors will be displayed on the SYSTEM ERROR LIST screen
222. rve Fiber Layer Maps If the baselines are not consistent GPA will be less able to tlag progression 2 Examine GPA printout Review the color code RNFL I summary box A yellow Possible progression summary box indicates additional follow up visits are recommended to confirm change A red Likely progression summary box indicates statistically significant change is detected in measurements A grey Possible increase summary box could indicate high measurement variability especially when increase and progression are flagged simultaneously 3 Apply GPA results in context of the patient GPA reports statistically significant change for one eye which may or may not be clinically significant Correlate results with other clinical tests to detect glaucomatous progression Rate of progression locations of the detected progression age of the patient stage of the disease and other clinical factors should be evaluated for clinical decision Note The NFI is not analyzed in GPA It is a key component of the Symmetry Analysis report to help classify patients but is not an optimal parameter to track change over time GDxPRO User Manual Guided Progression Analysis GPA Report Contents Summary Box The GPA Report displays a color coded summary box that tells you immediately if significant change has been detected GPA has three different indicators for detecting different shapes of RNFL change each with a check box in the summ
223. s without exposure to any direct sunlight Use of controls or adjustments or performance of procedures other than those specitied herein may result in hazardous radiation exposure Always clean the patient contact surfaces of the face mask with alcohol pads prior to each use The GDxPRO weighs approximately 50 pounds 22 5 kg To avoid injury exercise proper lifting techniques when lifting or moving the GDxPRO Allow the system to acclimate to room temperature before turning on the power GDxPRO User Manual Introduction 111 Be sure not to apply power to the GDxPRO until all connections are secure and the instructions specifically advise you to apply power System lockup may occur and require a power down power up sequence if all connections are not made as described in this manual Remove the foam protector from in front of the objective lens and unlock the scan head before turning on the power see Instrument Setup on page 2 1 Confirm that the objective lens is clean before imaging patients see Routine Cleaning amp Disinfecting on page E 12 Do not use any sharp objects ball point pens etc to operate the touch screen It can be easily scratched WARNING Do not insert a lens mirror or other optically active device between the system and the patient the patient may wear prescription contact lenses Doing so may result in a higher than normal energy density in the eye that could injure the patient What to Do for the GD
224. s of individual data to the normative database do not take into account differences that may be present due to race ethnicity This data is provided for your information only Data Analysis For each calculation circle the ECC readings of the same parameter trom different images of an eye were averaged and the average readings were treated as the measurement of the parameter at that region of the eye The regression model analyses were used to estimate the normative limit of the GDx parameters adjusted by age Since the gender differences were not statistically significant the gender was not included in the regression model The site effect was not considered in the normative limits calculation since the objective was to establish the normative limits for the general population For each titted regression model the residuals were derived for each eye by subtracting the estimated mean GDx reading ET age from the measured or observed reading rt age In other words residual rt age ET age The goal was to estimate the 100xa percentiles NL normative limit of the residuals so that 100xa of normal subjects would have a value of the GDx parameter less than the following limit ET age NL 100xa A For each GDx parameter the percentiles NL 100xa of its regression residuals were estimated by the empirical distribution of the residuals Hence the age specific normative limit of each GDx parameter was estimated by limit A abo
225. se that workgroup name 5 When you complete NAS device configuration exit the configuration program and remove the CD from the GDxPRO optical drive GDxPRO User Manual Vsiteo4 File Edit View Favorites Tools Help a P T Search Back Address E Vsitel4 Folders Ej Desktop Network Storage Device Configuration On the GDxPRO Map a Network Drive to the NAS Device In some cases the configuration software of the NAS device automatically maps the correct folder of the NAS device to a drive letter on the GDxPRO When this is the case configuration is complete and the NAS device is ready to use In other cases you must map a drive on the GDxPRO to the proper folder of the NAS device using Windows Explorer 1 Select the Windows key z on the keyboard to see the Windows Start menu Right click on Start and select Explore 2 In the Explorer Address field type two backlashes and then the NAS device name you recorded in step 4 B above and press Enter Note If you failed to record it properly note that you can often find the NAS device name on a label on the back of the NAS device The device name for this purpose may be presented as the Network ID Enter the entire network ID device name after the two backslashes with no spaces If you have typed the device name correctly and the NAS device is correctly config ured and turned on when you press Enter Explorer should find the NAS device on the left and display i
226. se or the Vertical Controls Figure 4 7 for optimal working distance Note You can also use the keyboard PgUp PgDn keys The white ball may not be visible or in focus until you scroll the mouse or use the Vertical Controls See Figure 4 7 for an example of correct alignment r amp IMPORTANT The mouse cursor must be in the live video image in order to use the scroll wheel for centering the white ball Refined adjustments of both the ball and pupil are often needed as the image approaches optimal alignment feat It needed select Restart Alignment to bring the alignment back to the default setting ga Note You may notice two or three additional smaller white balls within the area of the patient s pupil These are reflections from the eye that have no bearing on the image and working distance and should be disregarded os Note Pupil dilation is not recommended and may make white ball alignment difficult since the white ball is a reflection from the iris For a partially dilated eye follow the steps below to catch the edge of the iris Measurements on fully dilated eyes are not recommended 1 Align pupil slightly off the center of the yellow crosshairs until the white ball becomes visible 2 Align the white ball until it is centered on the horizontal red line 3 Center the partially dilated pupil on the yellow crosshairs GDxPRO User Manual Right Click iS Scanning Procedures Measurement Acquisition Instruct
227. sed chance that the Fast Mode result be a false positive Using Pre existing Data Until you have enough data to use Extended Mode you can make mean images from Triple Scans and use them with your existing single scans in Fast Mode GDxPRO User Manual Guided Progression Analysis GPA il GDxPRO GPA Algorithms GDxPRO GPA implements two different algorithmic approaches to determine significant change based on GPA mode Table 7 2 Both algorithms require a minimum of 3 visits e CFB Change From Baseline Based on changes from two baseline exams compared to measurement variability CFB is most sensitive when there is little variability between the baselines Mean readings are treated as single data points e SIM Statistical Image Mapping Based on trend analysis All visits contribute to change detection as opposed to CFB in which only the first two and last two visits are used to determine if change occurred therefore SIM is able to detect progression between the first two visits better than CFB Table 7 2 GPA Algorithms mage Progression Map RNFL I Summary Parameter Charts Statistical Significance Progression Analysis compares an observed change with its expected test retest variability as illustrated in Figure 7 1 Cutoff Point for Flagging Possible Increase i e a 2 98 Cutoff Point for Flagging Possible or Likely Progression i e a 2 2 0 Measured RNFL I Change Changes considered wit
228. sis til Select the Windows key z on the keyboard This will cause the Windows Task Erase Disc Alt E Bar to appear along the bottom Notice the icons in the System Tray at bottom right When you mouse over an icon its name appears Drag to Disc Help Center 4lt H a n About Drag to Disc lta 3 Right click the Roxio Drag to Disc icon a and select Format Disc from the pop up Exit Drag to Disc menu as shown on the left The Drag to Disc Format Options dialog appears Launch Scandisc See Disk Format Options below Disk Format Options CD R and DVD R disks No format options are available for CD R or DVD R disks Figure D 3 Drag to Disc Format Options volume label Export 1 Enable compression on this disc Figure D 3 CD R Format Options It desired type a name in the Volume Label field Click OK to begin formatting A Drag to Disc Preparation dialog appears during formatting Formatting is brief The dialog disappears when it is complete Once formatted you cannot format CD R or DVD R disks again nor can you erase them GDxPRO User Manual Data Transfer Using Optical Disks CD RW and DVD RW Format Options For a new blank CD RW or DVD RW you have only the option to perform a full format Figure D 4 Drag to Disc Format Options Volume Label Export 1l Enable compression on this disc Format Types for Rewritable Discs f Full Format Format the entire disc before using it Help Cancel
229. size of this shift depends upon both the RNFL thickness and the cumulative level of organization of its microstructures The greater the phase shift the higher the RNFL I measurement Scan The process of acquiring a measurement During a scan a projected laser dot is scanned across the retina and the reflected light is collected This is performed 32 times with different polarization settings and a frame of data is collected each time Scanning Laser Polarimeter Scanning laser polarimetry SLP a technology for glaucoma diagnosis uses imaging polarimetry to detect the birefringence of the retinal nerve fiber layer All GDx instruments use Scanning laser polarimetry technology SCC Software Corneal Compensation SCC is determined by analyzing the tixed compensation Nerve Fiber Layer Map in the macular region which is then applied to the same image to generate a compensated result SCC images can be reviewed and printed but not modified on the GDxPRO Selection List A list of choices such as patient names or exams that appear on the screen choices can be made by positioning the arrow over a selection and clicking the mouse button GDxPRO User Manual Glossary aa SLP Scanning Laser Polarimeter Polarimetry See Scanning Laser Polarimeter Statistically Significant Change Change that exceeds the expected measurement variability STD or SD Standard Deviation The standard deviation of a multiset of values is a measu
230. surement as the reference image to delete it e Measurements that are used as part of a mean cannot be deleted To delete measurements used in a mean first remove the measurement from the mean and then delete it or delete the mean e Deleting a mean will NOT delete images associated with that mean e Once deleted the measurement information cannot be recovered GDxPRO User Manual Managing Measurements Creating a Mean Measurement Manually To create a mean image select two to five measurements of the same type ECC or VCC and the same eye acquired on the same instrument within thirty days of each other and then select the Create Mean button Figure 5 6 Select the More button if you cannot see the Create Mean button The Create Mean button is only active if you have two to five ECC or VCC measurements selected of the same eye ga Note Although GPA allows the creation of means from two scans Extended Mode requires means of three Measurement List Full 4 GPA Progression Analysis report can be generated by selecting three to eight visits of the SAME type and selecting PrintfExporn Review Operator dsanini Patient Dave Sanini Patient ID 123 Pater Prima ee Clinic Dr Jones Hacienda Clinic Peribe M BETEADUROUNADA 1 1 30 2007 11 10 AM Cornea 1 30 2007 11 10 AM Cornea 1 30 2007 11 16 AM i Jones 1 30 2007 11 17 AM VCC B1 Ref 1 30 2007 11 20 AM YVCC B2 Ref Dr Jones 1 30 2007 11 20 AM OK Hean ERGENE 1
231. t focus for scanning the eye The refractive correction settings are stored in a database and are used for subsequent exams The refractive range is 13 to 8 diopters For existing patients with previous exams the SELECT REFRACTION screen Figure 4 5 is displayed at the beginning of a new exam Auto indicates the AutoFocus settings from the last AutoFocus scan will be used For new patients AutoFocus is enabled by default and the SELECT REFRACTION screen will be bypassed To change patient refraction during image acquisition select the Refraction button on an ACQUISITION screen Figure 4 6 to display the SELECT REFRACTION screen Figure 4 5 Select Refraction Please enter the patients refraction for each eye in quarter diopters 13 00D 8 00D using the keyboard or the up and down arrow buttons below Right OD Left OS et Cancel Up Down Up Down Right OD Right OD Left OS Left OS Figure 4 5 Select Refraction Screen AutoFocus Button Select AutoFocus to allow the system to determine the optimal focus position using the AutoFocus AutoFocus Scan or enter patient retraction manually Manual Refraction on page 4 8 Select OK to keep the current or new retraction settings and return to the ACQUISITION screen Selecting Cancel will exit the SELECT REFRACTION screen and return to the MAIN screen for existing patient exams or back to the ACQUISITION screen for new patients AutoFocus Scan The GDxPRO performs
232. t guarantee the accuracy of printed materials after the date of publication and disclaim liability for changes errors or omissions All instrument specifications are subject to change without notice Limitation Of Liability THE WARRANTIES CONTAINED HEREIN ARE IN LIEU OF AND EXCLUDE ALL OTHER WARRANTIES EXPRESS OR IMPLIED BY OPERATION OF LAW OR OTHERWISE INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR PARTICULAR USE NEITHER ZEISS MICROSOFT CORPORATION NOR ANY OTHER PARTY INVOLVED IN THE CREATION PRODUCTION OR DELIVERY OF THIS INSTRUMENT OR SOFTWARE COLLECTIVELY REFERRED TO AS CONTRIBUTOR S SHALL BE LIABLE FOR ANY DAMAGE LOSS OF USE OR LOSS OF ANY KIND ARISING OR RESULTING FROM ACTS OF GOD YOUR PURCHASE POSSESSION FAILURE TO FULFILL YOUR RESPONSIBILITIES AS TO PROPER INSTALLATION MANAGEMENT SUPERVISION OR USE OF THE GDxPRO OR SOFTWARE WHETHER SUCH LIABILITY IS BASED IN TORT CONTRACT OR OTHERWISE IF THE FOREGOING LIMITATION IS HELD TO BE UNENFORCEABLE ZEISS S AND CONTRIBUTOR S MAXIMUM LIABILITY TO YOU SHALL NOT EXCEED THE COST PAID BY YOU FOR THE INSTRUMENT ZEISS AND OR CONTRIBUTOR S SHALL IN NO EVENT BE LIABLE FOR DIRECT INDIRECT CONSEQUENTIAL OR INCIDENTAL DAMAGES INCLUDING DAMAGE FOR LOSS OF BUSINESS OR ANTICIPATORY PROFITS BUSINESS INTERRUPTION LOSS OF BUSINESS INFORMATION AND THE LIKE EVEN IF ZEISS OR ANY CONTRIBUTOR S HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE
233. tc to the USB and DVI I port that are plugged into electrical outlets Tips to Avoid Damage Note Users are not authorized to dismantle or modify the GDxPRO hardware Only Carl Zeiss Meditec authorized technicians should disassemble or service this instrument In the case of malfunction error messages or operational problems call Carl Zeiss Meditec customer service In the U S call 800 341 6968 Outside the U S contact your local CZM distributor This instrument has no special measures to protect against harmful ingress of water or other liquids classified IPKO ordinary equipment Do not place containers of liquid on or near the instrument nor use aerosols on or near it In case of emergency related to the instrument unplug the power cord from the wall outlet and call for service immediately Do not attempt to open the protective housing of the GDxPRO for any reason With the exception of the main power fuses and keyboard there are no user replaceable parts in the instrument For the replacement of any component accessory or peripheral except fuses or the keyboard call Carl Zeiss Meditec customer service In the U S call 800 341 6968 Outside the U S contact your local CZM distributor Although this instrument is designed for continuous operation it should be turned off when not in use for an extended period This instrument operates according to specifications under standard indoor office fluorescent lighting condition
234. te Of Birth joe March 20 1965 Ancestry Gender ie Cancel Primary Doctor Clinic ie Oppenheimer Hacienda Clinic Single Exam Triple Scan Review Delete b Figure 4 29 Triple Scan Button on Patient Information Screen Triple Scan acquisition allows you to acquire from 3 to 5 scans of one or both eyes At the end of the Triple Scan acquisition the Review MEAN screen will be displayed to create a mean image from the acquired images Triple Scan acquisition facilitates the creation of means of three measurements used in Extended Mode GPA analysis see Fast and Extended GPA Modes on page 7 2 See Figure 4 30 for the Triple Scan workflow for new and existing patients GDxPRO User Manual Scanning Procedures Triple Scan Workflow New and Existing Patient Create New Select Existing Patient Patient Select Select Triple Scan Triple Scan AutoFocus Corneal measurement and macular ellipse check OD OS gt Iris Image Check Review Corneal P Retake Image oo lalla Modify Ellipse Scan 1 OD OS eee gt Iris Image Check OD OS gt Iris Image Check _ F an Retake Image Review Triple gt Retake Image Review Triple gt Retal Scans 1 mennase Modify Ellipse s Gear Dg Modify Ellipse s Calculation Circle Calculation Circle Scan 2 OD OS Review Triple Scans 2 OD OS Review Triple Scans
235. ter Configuration for printer information A Glossary and Index is included Text Conventions e Click means left click except where right click is specified e Chains of menu items are indicated with the use of the gt symbol between items For example File gt Exit directs you to select Exit in the File menu Selecting buttons Select buttons and text fields by using your fingers and touching the touch screen You can also use your mouse over a button or text field and press click the left mouse button The OK button accepts the current screen and any data entered and moves to the next screen if applicable The Cancel button will cancel current activity on the current screen and return the display to the previous screen if applicable Electronic User Manual Access The GDxPRO User Manual in PDF format version 8 or later is provided electronically 1 In the GDxPRO application press the F1 function key 2 On the GDxPRO CD included in the instrument accessory kit You can view the User Manual PDF using any computer Note Once the GDxPRO User Manual is opened you can switch between the user manual and the GDxPRO application by pressing Alt Esc or Alt Tab System Hardware With the exception of the keyboard mouse and printer the GDxPRO System integrates all hardware components in a unit which includes the image acquisition optics the system computer and touch screen display Carl Zeiss Meditec o
236. ter the ONH ellipse one click moves one pixel Shift click moves 5 pixels Proper placement of the ellipse over the ONH should appear as shown in Figure 4 19 so T Le z F i k Ma 1 h s iy ks e i Th r 4 2 G a E j ps te E 4 h g a Y r t i ai d d k M a ie a a 1 4 1 i ES a i i hoa t k gt J E ho s i 7 i m i ONH ellipse well centered ONH ellipse not centered Figure 4 19 Proper Positioning of the ONH Ellipse Resizing the ONH Ellipse To modify the ONH ellipse size ellipse shown in green select the OHN Ellipse Size toggle button The ONH Ellipse Position button is displayed along with the Width Width Height and Height ellipse resize buttons as shown in Figure 4 20 Select the proper resizing buttons to resize the ONH ellipse one click moves one pixel Shift click moves 5 pixels The ellipse position will remain unchanged Modify Calculation Circle and ONH Ellipse Left 08 Ellipse Diameter Horizontal H 1210 pm Vertical 1675 pm Calculation ONH Ellipse Circle Position Width l Height Figure 4 20 Modify Calculation Circle and ONH Ellipse Screen Size Buttons GDxPRO User Manual Scanning Procedures E Resizing the Calculation Circle The Calculation Circle is the area between the two outer concentric circles on the IMAGE CHECK and other screens Figure 4 21 This area is where measurement
237. the AutoFocus function as an additional scan performed before the corneal or RNFL scans Figure 4 6 os Note You should repeat AutoFocus if patient refraction has changed from the last visit e g due to a corneal procedure or pathology Using AutoFocus each time has no adverse impact on GPA analysis AutoFocus is recommended for every new exam GDxPRO User Manual eS Acq uisition Current scan mode AutoFocus Scan Refraction nia Scanning Procedures Manual Refraction Use the Up Right OD Down Right OD Up Left OS Down Left OS buttons to select the correct spherical equivalent retraction for the appropriate eye Alternatively you may use the Tab key to highlight a retraction value box and then use the up and down arrow keys on the keyboard to select or use the keyboard to enter the correct value Select OK to save your settings The spherical equivalent SE is calculated by algebraically adding 2 the cylinder value to the sphere value from the spectacle refraction Examples If patient s spectacle refraction is 1 00 D sph 1 00 D cyl x 90 SE 1 00 D 1 00 D 1 00 D 0 50 D 0 50 D If patient s spectacle refraction is 1 00 D sph 1 00 D cyl x 120 SE 1 00 D 1 00 D 1 00 D 0 50 D 1 50 D Step 4 Acquiring the Image The ACQUISITION screen provides a live image of the patient s eye Figure 4 6 AutoFocus Age Range Laser ON indicator 50 59 Ancestry Com
238. the patient to blink once Promptly check the pupil and white ball alignment make necessary fine adjustments and then Right Click the mouse or select the Acquire button to acquire the scan making sure the P ease Wait indicator is not displayed Note The pupil must be centered on the yellow crosshairs and the red line must be centered on the white ball Otherwise the scan may not pass the image quality check and will need to be repeated Note Instruct the patient to blink just before selecting the Acquire button then not to blink during acquisition between the first and second beeps less than 1 second WARNING If using the touch screen to select the Acquire button touch gently so as to not make the instrument move Using the mouse is recommended Note While scan acquisition is in progress a Please Wait indicator at the top center of the display will turn red Do not move or push any controls buttons during the image acquisition period while the Please Wait indicator is red The system will beep once when the Acquire button is selected or the mouse right clicked and again as soon as it has completed At the sound of the second beep instruct the patient to remain in position and blink normally Note The volume of the beep and the beep sound itself can be changed in the Windows XP Control Panel Start gt Control Panel gt Sounds and Audio Devices To change the beep sound select the Sounds tab and then change the Default Be
239. the protective housing is hazardous Class IIIb Laser and could cause personal injury No user maintenance is required or allowed WARNING Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure GDxPRO User Manual gt e Introduction WARNING Do not use any additional mechanical or optical devices lenses in conjunction with use of the GDxPRO Prescription contact lenses may be used Phototoxicity Statement FDA Opthalmoscope Guidance Direct and Indirect issued July 8 1998 Because prolonged intense light exposure can damage the retina the use of the device for ocular examination should not be unnecessarily prolonged and the brightness setting should not exceed what is needed to provide clear visualization of the target structures This device should be used with filters that eliminate UV radiation lt 400 nm and whenever possible filters that eliminate short wavelength blue light lt 420 nm The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time If the value of radiance were reduced in half twice the time would be needed to reach the maximum exposure limit While no acute optical radiation hazards have been identified for direct or indirect ophthalmoscopes it is recommended that the intensity of light directed into the patient s eye be limited to the minimum level which is necessary fo
240. the same color code as the rest of the report Possible Progression Likely Progression and Possible Increase are shown as yellow red and purple dots respectively Baseline images are shown as a circle with a black dot A regression line is only drawn if there is Likely progression and there is a significant linear trend p lt 5 Rate of Change P m yr 07 21 2005 4 7 3 5 p 2 3 me Tees m s an m a a Sample courtesy of Robert M Weinreb MD Felipe A Medeiros MD PhD Hamilton Glaucoma Center University of California San Diego Rate of Change P um yr 07 21 2005 10 8 9 0 p 3 2 Figure 7 12 RNFL I Summary Parameter Charts The slope rate of change is displayed in P um year with 95 confidence interval values For example with a slope of 3 9 1 1 we can be 95 confident that the slope is between 2 8 and 5 0 P um year This is shown graphically in the shaded gray area r amp Note 20 P um is the lowest value on the charts because this is typically the lowest measurement re Note GPA analysis does not perform any age related corrections GDxPRO User Manual Guided Progression Analysis GPA Dual Baselines A useful feature of GPA is that the user can add a second pair of baselines Two baseline sets can generate two regression lines and prediction intervals The new prediction interval is shown on the chart with a darker grey color its regression line is shown in red a
241. ther than a list of previously acquired exams to select GDxPRO User Manual Managing Measurements AKE Select an exam by using the mouse or the Previous Next and Select Deselect buttons You may also use the up and down arrow keys on the keyboard Measurement List Full oD 7 11 2007 09 47 VCC Dr Jay Lawrence 7 11 2007 12 53 VCC Dr Jay Lawrence oD 7 11 2007 12 56 VCC Dr Jay Lawrence oD 7 11 2007 13 01 VCC Dr Jay Lawrence oD 7 11 2007 13 03 VCC Dr Jay Lawrence oD 7 11 2007 13 05 VCC Dr Jay Lawrence Cancel eS EA Comment Operator mwarning j YCC full exam r Select f Figure 5 10 Add Exam to Mean Manual Mean Creation Select the Add Exam button to add the selected exam to your list on the REVIEW MEAN screen To remove an exam from your exam choices select an exam on the Review MEAN screen by clicking on the Select Image button until the exam you want to remove is selected with red border and then select the Remove Exam button A dialog Figure 5 11 will be displayed confirming that you want to remove the exam Select OK to remove the exam and regenerate the mean Select OK to remove the selected measurement from the mean Selecting OK will regenerate the mean Figure 5 11 Remove Exam from Mean GDxPRO User Manual Managing Measurements Select Accept or OK to accept and save the mean created trom the selected images An OPERATOR INFORMATION screen Figure 5 12 will be displayed allowing y
242. thumbnail image of the measurement is displayed in the upper right of the display Operator comments entered at exam acquisition or mean generation are displayed below the list for the currently highlighted measurement see Figure 5 13 On Screen Exam Review The review screens displayed when you select the Review or OK button on the MEASUREMENT List screen depend on the type and number of measurements selected e The IMAGE CHECK MEASURING CORNEA screen will be displayed for corneal measurements See Checking the Corneal Measurement on page 4 14 for a discussion of the IMAGE CHECK MEASURING CORNEA screen e The REVIEW CALCULATIONS screen will be displayed if there are only enough measurements for the Symmetry Analysis report See 6 Symmetry Analysis for a discussion of the REVIEW CALCULATIONS screen and the Symmetry Analysis report Examples of Symmetry Analysis reports are shown in Symmetry Analysis Examples beginning on page 6 12 e The PROGRESSION ANALYSIS REPORT screen will be displayed if enough measurements were selected for GPA See 7 Guided Progression Analysis GPA for a discussion of the Progression Analysis report Examples of GPA reports are shown in GPA Examples beginning on page 7 16 GDxPRO User Manual Managing Measurements Printing Exporting Exams GDxPRO provides multiple report formats for printing and exporting On the REVIEW CALCULATIONS screen Figure 6 1 or with the desired measurements selected on the
243. ties Eject Disc Choose Recorder Format Disc Rename Disc Erase Disc Drag to Disc Help Center About Orag bo Disc Exit Drag to Disc Launch Scandisc Alt K Alt 5 Alt Alk O Alt Alki AlL F Alt E Alt H Alt A Data Transfer Using Optical Disks Upon completion of the data transfer press the CD DVD eject button A Drag to Disc Eject Options dialog box is displayed Figure D 1 Select Eject to eject the disk Drag to Disc Eject Options Drag to Disc How would you like Drag to Disc to prepare this disc for future use C This disc will be used on this computer only f This disc will be used on other computers or devices Protect disc so that it cannot be written to again i Always show this dialog when ejecting a disc Advanced Cancel Help Figure D 1 Drag to Disc Eject Options Dialog Box Note You must first format the disk as described in Disk Formatting on page D 3 See Importing and Exporting Data on page 8 7 for more information Rename Disc After export is complete to rename the disc follow these steps 1 Select the Windows key a on the keyboard This will cause the Windows Task Bar to appear along the bottom Notice the icons in the System Tray at bottom right When you mouse over an icon its name appears 2 Right click the Roxio Drag to Disc icon and select Rename Disc from the pop up menu as shown on the left or press Alt R from the keyboard The Drag to Dis
244. ting the now named Full List button instead of Mean Image List Measurement List Mean 4 GPA Progression Analysis report can be generated by selecting three to eight visits of the SAME type and selecting PrintfExporn Review Operator dsanini Patient yg K Patient ID 234 a Primary Doctor Clinic Dr Oppenheimer Hacienda Clinic ke ena E Eye Exam Date Mode Exam Doctor 7 21 2008 11 00 ECC Mean Dr Oppenheimer os 7 21 2008 11 01 ECC Mean Dr Oppenheimer Mean Measurements 7 21 2008 10 55 T 21 2008 10 59 F 21 2008 11 01 Cancel Comment Previous select Full List Print amp Export Review Deselect Options Select the Full List button to return to the full list of measurements Figure 5 2 Measurements List Mean Screen If you wish to review the exam s or preview the reports on screen before printing and or exporting select Review If you wish to print and or export exam s or reports without review select Print amp Export Options see Printing Exporting Exams on page 5 6 Auto Selection When you select Review on the PATIENT INFORMATION screen GPA automatically selects the exams to be analyzed Auto selection is based on the current measurement last acquired for both OD and OS and the baseline exams The measurements automatically selected are of the same type as the current measurement If the current measurement is a mean created from ree measurements only previously acquired means of t
245. tion shows VCC NFI values under 37 Please see Table A 9 below for confidence intervals for these values 95th percentile 29 0 33 5 99th percentile 33 5001 Table A 9 Confidence Intervals Note that the NFI was developed and validated without using patients who were considered glaucoma suspects but only eyes with a clear cut diagnosis of normal or glaucoma Thus its utility in eyes diagnosed as glaucoma suspects remains to be established Note The NFI cannot be used alone to classify patients into normal and glaucoma categories This parameter cannot replace clinical judgement and is intended to be used in conjunction with the multiple clinical tools considered the standard of care for glaucoma diagnosis This device is not intended to be used as the sole basis for diagnosis of eye disease In summary a high NFI value usually indicates increased likelihood that the polarimetric retinal nerve fiber layer is abnormal but is not definitive It should not be used in isolation to diagnose glaucoma GDxPRO User Manual Network Storage Device Configuration AE B Network Storage Device Configuration Introduction This appendix instructs you how to configure a network attached storage device NAS device also known as a network drive for use with the GDxPRO These instructions provide requirements and recommendations for the NAS device but are generic with respect to brand the choice of which is at the
246. tors On the bottom right side of the GDxPRO are computer connectors as shown below Power Cord Connector Power Switch Fuse Holder Ethernet Port 2 USB Ports Figure 1 6 Bottom Right Side Connectors GDxPRO User Manual Introduction Left Side Connectors On the bottom left side of the GDxPRO are computer connectors as shown below Recessed USB Port USB Port DVI I Port Figure 1 7 Bottom Left Side Connectors Keyboard The keyboard is used to type in patient information such as names birth dates and examination remarks GDxPRO Instrument Software Carl Zeiss Meditec pre installs all software necessary to operate the GDxPRO System instrument Software updates with installation instructions may be provided on CD or on our website Data Storage We recommend archiving data to a network file server or a network attached storage device also known as a network hard drive which operates just as a network file server For more information see B Network Storage Device Configuration For non networked environments an external USB hard drive can be used External Device Equipment WARNING To maintain patient safety an isolation transformer is required when connecting externally powered peripheral devices i e printer USB drive etc within 1 5 meters 4 9 feet from the patient In addition an isolation transformer is required for all externally powered peripheral devices outside this distance unless these devices are
247. ts contents on the right as in the Windows XP example below ea Folders Ei x Name Comments k config E My Documents og Public i P My Computer Ta Printers and Faxes Shows installed printers and Fax E amp 4 My Network Places at Novell Connections E Entire Network Microsoft Terminal Services E Microsoft Windows Network E fy Mshome 4 Workgroup FM Siten sitet NetWare Services amp Web Client Network a Recycle Bin Figure B 1 Explorer Finds NAS Device and Displays Its Contents GDxPRO User Manual Network Storage Device Configuration AE 3 Now you must map a drive on the GDxPRO to the NAS device folder that is accessible to all users for storage In the example above the folder named Public is the correct folder The folder name for your NAS device may be similarly indicative that it is intended for use as the storage folder Consult the manufacturer s instructions to determine which folder is intended for this purpose 4 Click to select the correct storage folder Click Tools gt Map Network Drive The Map Network Drive dialog appears Map Network Drive Windows can help you connect to a shared network Folder and assign a drive letter to the connection so that you can access the Folder using My Computer Specify the drive letter For the connection and the Folder that you wank to connect to Drive z hoa Folder imss 017ad1 Public
248. ture Calibration Status Operating system Resources Calibrate Touch Screen Component Test system Test Figure 8 21 System Diagnostics Screen Automatic System Test The automatic system warm up is set to run each day when the unit is first turned on If your system is left on overnight not recommended it will run at 2 00 am each day The test usually takes several minutes If the unit is cold i e if the unit was transported from another office it may take up to 30 minutes for the system to warm up and pass the system test During the test the clock in the upper left of the Warm UP screen counts up the time from the start of the test and the light blue dot continuously repeats moving across the screen left to right indicating the test is in progress If there are no errors the GDxPRO will start up normally If there are any errors the startup procedure will stop and a screen will be displayed with a list of the errors If any of the errors are critical and affect scan acquisition acquisition mode will be disabled If this happens you will be directed to the next step through the SYSTEM ERROR LIsT screen Figure 8 24 GDxPRO User Manual System Functions AA User Initiated Tests User Initiated Tests can be run by selecting System gt System Diagnostics gt System Test Figure 8 21 System Test Cancel Ea Ea Choose the Desired Test single System Continuous View Test Test Results F
249. uded below First we offer help in determining the source of power problems Note Except for fuse replacement only authorized Carl Zeiss Meditec service engineers may disassemble the instrument and replace parts If fuse replacement does not repair the problem or if another sort of problem prevents normal operation contact Carl Zeiss Meditec customer service In the U S call 800 341 6968 Outside the U S contact your local Carl Zeiss Meditec distributor Determine the Source of the Power Problem This section assumes that the instrument will not power on Troubleshooting your power problem depends on whether or not you power the instrument through the optional power table GDxPRO User Manual Maintenance If Not Using the Optional Power Table If you power the instrument directly trom a wall outlet not through the optional power table check the following to determine the source of the power problem in order 1 Is there power available everywhere in your office e If not there may be a localized power outage in your office or a general power outage in your neighborhood e If so proceed to step 2 2 Is the instrument power cord plugged in at both ends e If not plug in the cord and try to power up the instrument e If so check the instrument fuses and replace them if necessary See Check and Replace Instrument Fuses on page E 2 for instructions If Using the Optional Power Table If you are using the optional power table
250. urations for communication between instrument and printer 1 Network Configuration page C 3 either via direct connection between instrument and printer or via connection of instrument and printer to a local area network 2 USB Configuration page C 4 via direct USB connection between instrument and printer Approved Printers CZM recommends using a printer that has been specifically qualified for the GDxPRO because untested drivers could interfere with instrument operation Please contact your CZM representative for qualitied printers in your geography Many printers are available that are compatible with Microsoft Windows XP Please note if you use an unqualified printer with the GDxPRO CZM cannot guarantee technical support Repairs necessitated by the attempt to use a non qualified device are not covered under warranty Any printer considered must meet the following criteria e Windows XP compatible e Network port or USB port the network port must be 100 10 100 or 10 100 1000 Base T If a USB port is used an isolation transformer is required e Color printing e Ability to print on 8 5 x 11 paper in the US or appropriate paper size outside the US WARNINGS We strongly recommend you use printers supplied or approved by Carl Zeiss Meditec when available because they will have been tested to work with the instrument Installation of any unapproved software including drivers could degrade the performance of the instrument a
251. ure it is recommended to use a unique patient identifier generated from an EMR PMS system for ease of integration Patient ID Last Name First Name Date of Birth and Doctor Clinic fields are required data If the desired doctor is not listed in the Doctor Clinic field you must exit the New Patient function and first associate the desired doctor with the current Operator or add a new doctor see Setting Up Operator Doctor on page 2 6 GDxPRO User Manual Managing Patient Records tE Select OK to continue to the ANCESTRY screen Figure 3 3 Ancestry Navigate the ancestry list by using the previous and next commands Once the ancestry is selected press the OK button Choose an ancestry Com bined Cancel EA Combined Previous Select the appropriate ancestry trom the drop down list The default is Combined no specific ancestry is selected Figure 3 3 Ancestry Screen os Note Neither ancestry nor gender selections have any bearing on calculations the normative databases are a mixture of ancestry and stratified only by age Ancestry selection is included in the event ethnic specific normative databases are developed GDxPRO User Manual Managing Patient Records Click OK to continue to the GENDER OPTIONAL screen Figure 3 4 Gender Optional Cancel E Choose a gender Female At the GENDER OPTIONAL screen select Female or Male to continue to the PATIENT INFORMATION screen
252. uspected Early RNFL LOSS oo cccccccseceseeteeseeseteteeseesees 6 16 7 Guided Progression Analysis GPA ssssssnnnnnnnnnnnnnnnnnnnnnnn 7 1 Chapter Oveni eW asians cexinutscsaielenited a a 7 1 I MULOGUCTION to GPA nee e a 7 1 e Fast and Extended GPA MOdeS cccecccscesseseeeeeseeseeseeeeeeseeeaeeaes 7 2 Statistical Significance es sisted sion ele eens 7 3 e Generating a GPA RQDOMt sccacccsccszesceccussceesasnncennvezdeacnnadesseneeveneatentsens 7 4 e Reference Images Baselines and Excluded Measurements 7 5 eSetting the Reference Image for Automatic Image Alignment ies SOUIMG BAS CINE en a aE 7 6 SEXGIUCING Meas UCTS aan hans eauebinuadacgutanentinentness FI eRemeasuring Corneal Measurements ceccceeceeseceeseseeseteetesteteeeeees Fl e Overview of the GPA Report c csccsscssssessssessrsssssrsssssrsseeeaes 7 8 e How to Read the GPA Report sssssesssssssesseesnernsresneersnnrnssnsrnsrrsrnsnas 7 9 SREDOM CONTENTS sinetron crease tenendesenctes at cnshascceursteneesitenca 7 10 SUMMA BON aise ke sos aes as E 7 10 Image Progression Map best for focal Change s s 7 11 eTSNIT Progression Graph best for broader focal change 06 142 eRNFL I Summary Parameter Charts best for diffuse change 13 e Nerve Fiber Layer Maps and Progression Ma 5S cccccccsecseeseneteeen 7 14 e GPA EXAM DIOS scesocsscecacscannsezestadarctemassnssaessetestd
253. ve The levels a of the normative limits were presented as 0 5 1 2 5 The normative limits were estimated for the Nerve Fiber Layer Map based on the same regression analysis approach The following is an example taken from actual database values For the TSNIT Average at age 50 5 Normal Limit 45 2 2 Normal limit 43 1 Thus 5 of healthy individuals have TSNIT Average measurements below 45 2 and 2 of healthy individuals have TSNIT Average measurements below 43 1 Therefore a person with a TSNIT average of 45 would be flagged at the 5 level The widths of confidence interval for the residual percentiles of ECC TSNIT Average Superior Average Interior Average TSNIT Standard Deviation and Inter Eye Symmetry are presented in Table A 1 GDxPRO User Manual RNFL Normative Databases and NFI A 5 a ae oa ooo f w 3 1 a o f awe faa D et fa ooo y w f o Ct fo et fo sr Table A 1 Width of Confidence Intervals of Percentiles For reference the repeatability and reproducibility of the GDx ECC measurements are presented in Table A 2 and Table A 3 below Repeatability Reproducibility Repeatability Reproducibility Parameter SD SD Limit Table A 2 ECC Repeatability and Reproducibility Normal Study Eyes GDxPRO User Manual RNFEL Normative Databases and NFI Repeatability SEPSA Ey Repeatability Reproducibility Parameter SD Limit Limit srw ses wane a Inferior Average TSNIT Standard
254. w and turning the screw counterclockwise until it is loose and turns freely see Unlocking the System on page 2 2 Then perform the power up procedure see Powering Up the Instrument on page 2 2 Note Carl Zeiss Meditec offers an optional transport case for your convenience to safely transport your GDxPRO We recommend that you use it whenever the need arises to transport the GDxPRO from one location to another Contact CZM sales department to order a transport case in the U S call 877 486 7473 outside the U S contact your local CZM distributor GDxPRO User Manual Maintenance E 11 Handling Error Messages If the system fails to start or if some other error prevents the system s normal function document the circumstances and any associated error messages and report it to Carl Zeiss Meditec customer service In the U S call 800 341 6968 Outside the U S contact your local Carl Zeiss Meditec distributor Often error messages can be resolved with solutions provided over the telephone Please be prepared to provide CZM the serial number of your instrument It is located on the label on the lower left of the right side of the instrument see Product Labels and Serial Number Location on page 1 22 Hard Disk Defragmentation Defragmentation of the GDxPRO computer hard disk may become necessary after some time The process of deleting data and then writing again to the hard disk fragments the hard drive which degrades database an
255. xPRO Always handle the GDxPRO with care Always select a location for your GDxPRO that allows easy access for both patient and technician Always operate the GDxPRO from a power source as specified This source should be a dedicated line Use of a power source other than indicated on the unit will shorten the life of the unit and may cause damage in addition to improper operation Always operate the GDxPRO with the power cord inserted into a standard three prong power outlet that is correctly grounded through normal wiring Always route electrical cables with safety as the first concern Always unplug the GDxPRO before moving the GDxPRO opening the panels or inserting and replacing the removable hard drive Always let the GDxPRO reach room temperature before it is powered up This is particularly important if the GDxPRO was exposed to temperature extremes Always operate the GDxPRO within the following working ranges of temperature and humidity e Ambient Temperature 50 F 95 F 10 C 35 C e Ambient Humidity 10 75 Always unplug the GDxPRO before cleaning the plastic body panels or LCD screen If the LCD or other body panels require more than a dusting apply a mild household cleaner to a soft cloth to clean them Always clean the patient contact surfaces of the face mask with alcohol pads prior to each use GDxPRO User Manual Introduction Other Recommendations e Use a UPS Uninterrupted Power Supp
256. y to be related to abnormality but is not definitive It is calculated using an advanced form of neural network called Support Vector Machine SVM The NFI is trained on known normal and glaucomatous eyes and essentially uses pattern recognition to establish an outcome Specifically the ECC NFI was developed utilizing 251 normal subjects aged 18 82 and 215 glaucoma subjects aged 28 89 from the clinical study Collection of Normative and Glaucoma Data Using GDx VCCIM Scanning Laser Polarimetry Of the 466 subjects in the study 314 were in the model building dataset on which the NFI was trained The remaining 152 subjects were in the validation dataset Data analysis from this validation dataset is presented below Figure A 4 shows the ECC NFI distribution of normals and glaucoma subjects in the validation data set N 152 ECC NFI N 152 15 g Normal B Glaucoma Number of Eyes o i 2 30 40 50 60 70 B80 0 100 NFI Figure A 4 ECC NFI Distribution Validation Dataset Data analysis of the normal subjects used in ECC NFI validation reveals the following Table A 4 e 95 of the normal population shows ECC NFI values under 35 e 99 of the normal population shows ECC NFI values under 55 Po ECC NFI 95 Confidence Interval ma Table A 4 NFI Guidelines for Likelihood for Normal GDxPRO User Manual RNFL Normative Databases and NFI A 9 The characteristics of the normal subjects were explained in the ECC RNFL Normat

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