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Instructions for Use

1 Safety and Certifications

2660021169042 Rev. A 2018-03

1.5 Operator Training and Equipment Maintenance

2660021169042 Rev. A 2018-03

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1.5 Operator Training and Equipment Maintenance

1.5.1 Operator Training

WARNING!

Incorrect use of equipment

could result in damage to patients or equipment.

Only personnel who have undergone appropriate training and
instruction may use this device.

Operating personnel must be appropriately trained and
instructed.

Operating personnel must read and understand the User
Manual.

The User Manual must be made available to operating
personnel at all times.

To facilitate access for all operating personnel: Request
additional copies of user documentation as required from
ZEISS.

Specify the competencies for handling the device and state
who is authorized for what tasks.

Determine the reporting obligations for instrument error and/or
damage and make them known.

Regularly review the applicable legal regulations regarding
accident prevention, health and safety in the country of use.

1.5.2 Equipment Maintenance

CAUTION!

Lack of regular safety inspections

could result in a decrease in device safety, increase in the possibility
of device damage, and/or inaccurate results.

Regular technical safety inspections must be carried out as
specified for this device by any and all applicable national
regulations.

Equipment inspections may only be performed by Zeiss or Zeiss-
qualified personnel.

Comply with the specified maintenance intervals.

Carry out all inspections fully.

Minimally, local system inspections must include the following:

Availability of the Instructions for Use

Visual inspection of system and accessories for damage and
legibility of labels

Current leakage current test

Содержание PLEX Elite 9000

Страница 1: ...PLEX Elite 9000 Version 1 7 Instructions for Use...

Страница 2: ...ia Windows Server and Microsoft are either registered trademarks or trademarks of Microsoft Corpo ration in the United States and or other countries Mac OS iMac iPad and QuickTime are either registere...

Страница 3: ...5 1 Operator Training 27 1 5 2 Equipment Maintenance 27 1 5 3 Notification of Serious Incident 28 1 6 RoHS Compliance 28 2 Introduction 29 2 1 Scope 29 2 1 1 Intended Use 29 2 1 2 Indications for Use...

Страница 4: ...49 4 3 3 Review Station Performance 50 4 3 4 Installing Review Station Software 50 4 4 Installing User Documentation 53 5 Startup and Shutdown 55 5 1 System Startup 55 5 2 System Shutdown 55 6 Config...

Страница 5: ...82 8 5 2 Acquire HD Spotlight Scans 87 8 5 3 Acquire Montage Angio Data 91 8 5 4 Repeating a Prior Scan Track to Prior 96 8 6 Check Scan Quality 97 8 6 1 Quality Check Screen Angio 98 8 6 2 Quality Ch...

Страница 6: ...tient Data 156 10 3 1 Patient Privacy 156 10 3 2 Merge Patients 156 10 3 3 Move Scan 157 10 3 4 Editing Patient Records 158 10 3 5 Edit Patient Records 158 10 3 6 Print Patient Lists 158 10 3 7 Add a...

Страница 7: ...hin Cup and Forehead Rest 185 12 5 Cleaning Peripherals and Table 185 13 Maintenance and Repair 187 13 1 Safety During Maintenance 187 13 2 Device Access 188 13 2 1 Remove Rear Cover 188 13 2 2 Fan Fi...

Страница 8: ...219 16 3 Acknowledgment 220 17 Accessories and User Replaceable Spare Parts 221 17 1 Accessories and User Replaceable Parts 221 17 2 Parts Orders 221 17 2 1 U S Domestic Parts Ordering 221 17 2 2 Inte...

Страница 9: ...t fully understand potential safety hazards Read the following safety warnings and cautions in their entirety before using the instrument Additional warnings and cautions are found throughout the inst...

Страница 10: ...disposal facility 1 2 Definitions Warnings and Cautions are defined as follows WARNING Indicates hazards that if not avoided could cause the following Severe injury or even death The warning message n...

Страница 11: ...may install the instrument WARNING Installation of devices and systems by persons not autho rized by ZEISS can lead to the injury of patients and operators as well as to property damage Installation...

Страница 12: ...on in the configuration in which it will be used WARNING In case of an emergency disconnect the appliance coupler u For the device the most accessible power cord is the one that plugs into the bottom...

Страница 13: ...n or near the equipment CAUTION Using a non approved or incorrectly connected device could invalidate the system safety approval u Follow all indications in this user document to ensure that all conne...

Страница 14: ...2 Product Safety WARNING An ungrounded Device could lead to electric shock u Do not remove or disable the ground pin u Only an authorized ZEISS service representative may service the instrument u Onl...

Страница 15: ...Exception You may remove the rear cover to access labels and connectors WARNING Using the Device adjacent to or stacked with other equipment could impact device operation u If adjacent or stacked use...

Страница 16: ...t or over objects on the floor such as power cords CAUTION Placing containers of liquid on or near the instrument or using aerosols near it could damage the equipment u The instrument is not designed...

Страница 17: ...care practitioner u Purchasing from an unlicensed healthcare practitioner is against United States Federal law u Purchasing from an unlicensed healthcare could result in a non standard incorrectly ins...

Страница 18: ...ular examination should not be unnec essarily prolonged u While no acute optical radiation hazards have been identified for direct or indirect ophthalmoscopes it is recommended that the exposure time...

Страница 19: ...nally connected to non medical peripheral devices i e printers non system storage devices etc compromises patient safety u If a non medical peripheral device is located within 1 5 m from the patient t...

Страница 20: ...n transformer in the USB configuration u Ensure that patients cannot touch a peripheral device with any part of his or her body while being examined u Ensure the instrument operator does not attempt t...

Страница 21: ...IRS OR UPGRADES NECESSITATED BY THE ATTEMPTED PERFOR MANCE OF THE FOLLOWING ACTIVITIES ZEISS does not support the following network activities although they may be possible Printing with a printer not...

Страница 22: ...rections carefully u Do not make upgrades or carry out repairs or modifications without specific guidance and instruction from ZEISS or an authorized ZEISS represenative The following activities are p...

Страница 23: ...ion Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The PLEX Elite 9000 is suitable for use in all est...

Страница 24: ...ip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec Mains power quality should be that of a typical commercial or hospital environment If the user of the PLEX Elite 9000...

Страница 25: ...eters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vi...

Страница 26: ...tput power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GH...

Страница 27: ...ing the device and state who is authorized for what tasks u Determine the reporting obligations for instrument error and or damage and make them known u Regularly review the applicable legal regulatio...

Страница 28: ...tions must meet the normative requirements for medical systems see IEC 60601 1 1 or Clause 16 of the 3rd edition of IEC 60601 1 respectively u Anyone connecting additional equipment to medical electri...

Страница 29: ...as an aid in the visualization of vascular structures of the retina and choroid The PLEX Elite 9000 is indicated as a diagnostic device to aid in the detection and management of ocular diseases includ...

Страница 30: ...t The device may be used on all adults in need of diagnostic evalu ation of the eye This includes but is not limited to patients with the following disabilities or challenges Wheelchair user Very low...

Страница 31: ...nterpret the analysis in the treatment of ophthalmic diseases or other eye related medical issues The data of this device is to be interpreted by clinicians or techni cians with professional training...

Страница 32: ...ssfully Read all user documentation before starting and using the device Keep all user documentation where it is accessible at all times for all users Pass the user documentation on to the next owner...

Страница 33: ...by differences in scattering intensity In low coherence interferometry light is sent along two optical paths one being the sample path into the eye and one being the reference path of the interferomet...

Страница 34: ...educed absorption by melanin in the RPE not only allows light to pass more easily to the tissues beneath but reduces the potential for localized heating due to laser exposure Swept Source OCT has seve...

Страница 35: ...ns Montage Table 3 Montage Angio 15mmx9mm example 2 6 1 3 Segmentation Editing Intermediate Layers PLEX Elite 9000 identifies segmentation layers and estimates the layer boundaries Because some layer...

Страница 36: ...2 Introduction Instructions for Use 2660021169042 Rev A 2018 03 2 6 PLEX Elite 9000 Technology 36 246 2660021169042 Rev A 2018 03...

Страница 37: ...m Overview 3 1 Hardware Overview The PLEX Elite 9000 will be unpacked and installed for you components shown below 1 2 3 4 5 6 8 7 9 10 1 PLEX Elite 9000 Acquisition Device 2 PC Workstation 3 Computer...

Страница 38: ...te 9000 Acquisition Device 1 Port for External Fixation Arm 2 Head Rest 3 Imaging Aperture 4 Dual Chin Rest with Automatic Right Left Sensors 5 Motorized Patient Alignment Unit 3 1 2 PC The PC provide...

Страница 39: ...A 2018 03 39 246 3 1 3 Monitor 1 2 Figure 5 Monitor 1 Function Buttons 2 On Off Button NOTE It is not necessary to turn off the monitor 3 1 4 Network Attached Storage NAS 1 2 3 Figure 6 Network Attac...

Страница 40: ...work Switch Back 1 Ethernet Ports 3 1 6 Power Table NOTE Cables that connect components are routed under the table You do not need to disconnect or reconnect these cables 2 1 3 Figure 8 Power Table 1...

Страница 41: ...ens 2 Work Area Varies depending on mode and function 3 Navigation Bar Status indicator and mode selection common to all screens 3 2 2 Toolbar Each PLEX Elite 9000 screen has context specific menus an...

Страница 42: ...Import Exams Import some or all patient exams from a PLEX Elite 9000 database export Patient ID Mode Operator Export Exams Select and export patient records Patient ID Mode Operator Print Patient Lis...

Страница 43: ...sible Acquire mode Operator Auto Repeat Automatically adjusts the ocular lens and chinrest to the previous settings for the same patient eye and acquisition function Acquire mode Operator Tracking Tur...

Страница 44: ...user privileges All modes Admin Options Select Database Enables you to switch between different instrument databases Review Software Operator Admin 3 2 2 4 Help Menu Figure 13 Help Menu Option Descrip...

Страница 45: ...rent mode and opens the prior mode NOTE This button is only active in Acquire or Analyze modes 3 2 3 2 Navigation Status NOTE Mouse over the status indicator and popup text will explain the current st...

Страница 46: ...ument Only Acquire scans for the selected patient see Acquire Angio Cube and HD 51 Scans Screen 83 Acquire HD Spotlight Screen 88 and Acquire Montage Screen 92 3 Quality Check Screen Instrument Only A...

Страница 47: ...rself u Do not attempt to install any component of the device yourself u Do not attempt to connect any cables in connection with the device yourself u Do not attempt to setup or start the device or an...

Страница 48: ...ured data u Unless otherwise instructed by an authorized ZEISS Represen tative do not attempt to install software on your PLEX Elite 9000 NOTE These instructions are provided only for installing PLEX...

Страница 49: ...Content SW Software to install on review stations UD User Documentation 4 3 2 Review Station Requirements NOTE These instructions are provided for Review Station software installation only If you plan...

Страница 50: ...eview Station Performance NOTE All times are calculated based on an estimated network performance of 50 of theoretical u Actual performance for a typical clinical setting may differ and will depend on...

Страница 51: ...Rev A 2018 03 51 246 2 Navigate to the USB drive 3 Double click Setup exe NOTE Installation takes a few moments to prepare before the installation wizard opens The installation wizard opens prepares...

Страница 52: ...ogress bars indicate the progress of each step When all installation steps are complete the finish prompt opens 6 Click Finish The PLEX Elite 9000 shortcut appears on the computer s desktop The applic...

Страница 53: ...5 4 4 Installing User Documentation The user document is not installed during the software installation or update You can install user documents from documentation flash drive Documents are available...

Страница 54: ...Empty page for your notes...

Страница 55: ...use To turn on the PLEX Elite 9000 press the PC power button It is not necessary to turn on or off the instrument or any other system components or peripherals Action 1 Turn on PC power 2 Turn on NAS...

Страница 56: ...utdown 56 246 2660021169042 Rev A 2018 03 To turn off the PLEX Elite 9000 press the PC power button It is not necessary to turn off the instrument or any other system components or peripherals Action...

Страница 57: ...up the first PLEX Elite 9000 instrument at your institution complete the following settings Task Required Login as administrator Log in as Admin 59 Recommended Set Admin password Log in as Admin 59 Re...

Страница 58: ...allation Checklist 6 1 1 2 Configuring an Additional Instrument or Review Station When you add an instrument or review station at your institution complete the following settings Requirement Task Requ...

Страница 59: ...dministrator Prerequisite System Startup 55 completed successfully system login displayed Action 1 For User Name type admin 2 If this is the initial administrator login create a new password 3 If the...

Страница 60: ...Options Institution Edit 2 For Name type the name of your institution NOTE Institution name cannot be blank Type an insti tution name consisting of 1 64 characters 3 For Issuer of Patient ID type you...

Страница 61: ...mation displays including Model Number Sequence Number Serial Number Software Version Action 1 Select Tools Options Equipment Edit 2 For Station Name type an instrument identifier that is meaningful t...

Страница 62: ...Accounts NOTE Only Administrators can complete this task Prerequisite Log in as Admin 59 Action 1 Select Tools Options Users The Staff Registration dialog opens listing the users already added to the...

Страница 63: ...e the user s last name 4 For First Name type the user s first name 5 If available complete Middle Name Suffix Prefix and ID 6 For Password type a temporary password for the user 7 For Verify Password...

Страница 64: ...Click Edit The Edit Staff dialog opens 4 Update the user s Last Name First Name Middle Name Suffix Prefix and ID user type as required 5 To reset their password for Password type a temporary password...

Страница 65: ...Search 75 6 2 1 About Patient Categories Some institutions create patient categories to apply to their patients Your institution can create custom categories that are helpful to your clinicians Your...

Страница 66: ...etical order 2 Click New The Category Edit dialog opens 3 For Name type a name for the category up to 64 characters 4 Click Save 5 Optional For Description type a description up to 64 characters 6 2 3...

Страница 67: ...categories in alphabetical order 2 Select a category and click Delete A confirmation opens 3 Click OK 6 3 Setting Preferences 6 3 1 Setting Archive Synchronize Alerts PLEX Elite 9000 allows you to se...

Страница 68: ...6 3 2 Setting the Default Patient Screen To set the default patient screen Prerequisite Logging In as Operator or Data Analyst 73 Action 1 Select Records Preferences 2 Select the Display Options tab 3...

Страница 69: ...LEX Elite 9000 instruments and PLEX Elite 9000 Review Software work on networks that support Internet Protocol version 6 and version 4 The default setting is IPv4 NOTE Choosing the Incorrect Network P...

Страница 70: ...ce The frequency of this maintenance depends on how much your insti tution uses the instrument To set the maintenance schedule Prerequisite Logging In as Operator or Data Analyst 73 Action 1 Select Re...

Страница 71: ...intenance has been properly carried out in conformance with the Maintenance Schedules described in the Maintenance chapter CAUTION Neglecting to prompt the patient to move their head away from the chi...

Страница 72: ...ction 1 Wipe the chinrest and forehead rest with an alcohol pad and allow it to dry 2 Turn on the instrument System Startup 55 3 Select the Patient 74 7 3 Read and Understand Physician Instructions Fo...

Страница 73: ...inistrator created your user account Adding a New User 62 Action 1 Open the PLEX Elite 9000 application 2 Select your user name from the list NOTE Passwords are case sensitive 3 Type your password and...

Страница 74: ...ing Patient 8 2 1 1 Find Existing Patient Screen 1 2 3 4 5 6 Figure 17 Find Existing Patient Tab Pos Symbol Name Explanation 1 Find Existing Patient Tab Finds an existing patient by last name ID or ad...

Страница 75: ...instrument or a review station and the Patient screen is open Logging In as Operator or Data Analyst 73 Action 1 Select the Find Existing Patient tab 2 Type the patient s Last Name or Patient ID 3 Cl...

Страница 76: ...pecify the Date of Birth as xx xx xxxx and or their age Exam Date Specify an exam date or range You can also search for the patient by import date To search an archive or database for a patient using...

Страница 77: ...electronic medical record system 2 Refresh List Synchronizes with the electronic medical record system and updates the list 8 2 2 2 Viewing Today s Patients The View Today s Patients tab lists Patien...

Страница 78: ...the PLEX Elite 9000 is 2 mm which can usually be achieved without dilation For optimal repeata bility image the patient the same way at every visit Pupil size can influence Repeat scan results Images...

Страница 79: ...se a patient s prior scan select the scan with the setting you want to repeat The instrument applies the same settings as the prior scan and the chinrest moves into the position used in the prior scan...

Страница 80: ...re provides a variety of scan types for in depth analysis of ocular features and possible abnormalities Type Selection AngioPLEX Scans Angio 3mmx3mm Angio 6mmx6mm Angio 9mmx9mm Angio 12mmx12mm Angio 1...

Страница 81: ...n Scan Name Area Angio 3mmx3mm 3 x 3 mm Angio 6mmx6mm 6 x 6 mm Angio 9mmx9mm 9 x 9 mm Angio 12mmx12mm 12 x 12 mm Angio 15mmx9mm 15 x 9 mm Table 10 Angio Scans HiRes Tracking is available and turned on...

Страница 82: ...Montage Angio 12mmx12mm allows you to select different FOV options to accommodate patients with various retinal curvature Scan Name Grid Size of Composite Scans FOV Options Montage Angio 12mmx12mm 12x...

Страница 83: ...Acquire Screen Pos Symbol Name Explanation 1 Select one Scan Selection Selection list of scans available for OD right eye and OS left eye 2 Live Iris Viewport Iris Viewport Displays the live image of...

Страница 84: ...cation of the fixation target Reset Scan Pattern Returns to the default scan pattern position Reset Fixation Target Returns the fixation target to the center EDI Check Enhanced Depth Imaging to improv...

Страница 85: ...ine adjustment panel 8 5 1 2 Acquiring Angio Cube and HD51 Scans NOTE Artifacts that appear in a single cube scan can cause data misinterpretation u Always acquire cube scans with FastTrac retinal tra...

Страница 86: ...est settings 4 to position the image in the viewport 3 5 Click Auto Focus 5 and ensure that the pupil target 2 remains centered NOTE If the fundus image becomes dark after you click Auto Focus recente...

Страница 87: ...I 13 NOTE Do not disable EDI for cube scans 13 To reset the scan pattern click Reset 14 14 To recenter the fixation target click Recenter 15 15 Click Capture 16 NOTE If the capture button is outlined...

Страница 88: ...uire Angio Cube and HD 51 Scans Screen 83 1 2 3 4 Figure 20 HD Spotlight 1 Acquire Screen Pos Symbol Name Explanation 1 Frames Select the number of frames scan repeti tions Choose one 10 20 30 40 50 6...

Страница 89: ...een opens 1 2 3 4 5 6 2 Select HD Spotlight 1 1 under OD or OS The chinrest moves into place for the selected scan 3 Left click on the center of the pupil 2 in the viewport 3 The pupil target appears...

Страница 90: ...of the line to adjust the slice length 10 to spotlight in HD 11 Turn the rotation icons to adjust the slice angle 11 to spotlight in HD 12 To adjust B scan 12 image quality fine tune Enhance 13 polar...

Страница 91: ...gle scan Montage Angio 12mmx12mm 5 scan composite Montage Angio 15mmx9mm 2 scan composite 12mm x 12mm scan order 15mm x 9mm scan order Center C Superior Nasal SN Superior Temporal ST Inferior Temporal...

Страница 92: ...his section describes the unique elements of the montage acquire screen For information about the common elements of acquire screens refer to Acquire Angio Cube and HD 51 Scans Screen 83 1 2 3 4 Figur...

Страница 93: ...erior I Inferior Selected Scan Position Indicates which scan will be acquired next outlined in blue Acquired Scan Indicates which scans were already acquired Scan Not Yet Acquired Indicates scans they...

Страница 94: ...propriate for the patient 4 Left click on the center of the pupil 3 in the viewport 4 The pupil target appears in the viewport 5 If needed move the chinrest settings 5 to position the image in the vie...

Страница 95: ...Trac 12 NOTE If the capture button is outlined in red Capture is disabled If Capture is disabled turn off FastTrac and ensure that the Capture is enabled outlined in green The FastTrac icon turns gree...

Страница 96: ...epeat PLEX Elite 9000 automatically uses all of the prior scan s settings and adjustments for the new scan PLEX Elite 9000 allows you to repeat a patient s earlier scan using the same scan settings Wh...

Страница 97: ...ck Scan Quality NOTE Quality Check displays captured scans not live data Quality Check allows the operator to view captured scans to ensure that they meet acceptance criteria before saving them for an...

Страница 98: ...screen is the same for all sizes of Angio Scans 1 2 6 7 8 9 10 11 3 4 5 Figure 22 Angio 3mmx3mm Quality Check Screen Pos Symbol Name Explanation 1 Iris Image Iris image captured not live 2 Retina Stru...

Страница 99: ...g the scan ON OFF Tracked to Prior Indicates whether the scan is set to track to a prior exam Play Previous Next Scrolls through the cube as a movie Transparency Slider Indicates the transparency leve...

Страница 100: ...reen features refer to Quality Check Screen Angio 98 1 2 3 4 Figure 23 Angio Montage Quality Check Screen Pos Symbol Name Explanation 1 Navigation Aids Navigational aids C Select to view the Center sc...

Страница 101: ...s rescan images if there are any question regarding its quality Each individual scan must pass all checks listed in this procedure Retake scans that do not pass these checks To check scan quality ensu...

Страница 102: ...tance Criteria 104 Scan shows accurate motion no decorrelation tails no vascu lature in the RPE layer and superficial and deep retinal layers look appropriately different 11 Scan passes Segmentation A...

Страница 103: ...uses poor scan quality and can affect interpre tation of the images Shadows Shadows exhibit floaters or disease Floater dark area appears in different locations in multiple scans compare the flow en f...

Страница 104: ...ect is correlated with the brightness of the reflecting layer decorrelation tails may seem to disappear within the outer nuclear layer but appear strongly in the brightly reflecting RPE Table 16 Decor...

Страница 105: ...area not associated with pathological flow Bright area in the B scan shows that segmentation pushed down into the hyper reflective retinal pigment epithelium Any signal detected here is likely due to...

Страница 106: ...Empty page for your notes...

Страница 107: ...rt Name AngioPLEX Angio 3mmx3mm Angio 6mmx6mm Angio 9mmx9mm Angio 12mmx12mm Angio 15mmx9mm Angiography Analysis Enface Report Cube Cube 12mmx12mm 1024x1024 Cube 12mmx12mm 800x800 Cube 12mmx12mm 512x51...

Страница 108: ...sis and Report Screen Elements Screen elements common to the analysis and report screens are described below 1 2 4 5 6 7 8 3 Figure 24 Analysis and Report Screens Pos Symbol Name Explanation 1 Select...

Страница 109: ...ndus Overlay Displays the Fundus image over the selected scan Export all Images Exports all the presets the B scan and all displayed images with review edits and annotations as jpg files 4 Finish Repo...

Страница 110: ...to explore the retinal vasculature in the AngioPLEX Image You can manually adjust the depth and cross sectional of these layers using the Segmentation Lines on the B Scan and the Slice Navigators on t...

Страница 111: ...arency of the Thickness Map to reveal more vascu lature 4 Reversed Grey Scale Flow Data Flow displays or hides the flow data on B Scan Visualization Style 1 Color or 2 Color Transparency allows you to...

Страница 112: ...w and provide greater insight in the vascular components of the retina Algorithms provide guidance for estimating retinal layers and provides ten Presets based on these algorithms You can further adju...

Страница 113: ...ely slowly one per line of horizontal A scan 3 Magenta Scan Line1 Slow B Scan Navigation Moves to correspond to the position of the image in the cube of scan data 4 Fast B Scan Plane Front of cube The...

Страница 114: ...Predefined views that reflect specific layers within the retina See Using Presets 142 3 Custom Presets allow you to save your own layer settings 4 En Face image 5 The B Scan showing the location indic...

Страница 115: ...t management Zoom etc are accessed by hovering over either of the OCT Images or the B Scans Presets are an excellent starting point for exploring retinal topog raphy Presets are described in depth in...

Страница 116: ...data from both eyes The OD image appears on the left while the OS image appears on the right If the scans have been tracked the icon shows among the Option Buttons The horizontal blue Slice Navigator...

Страница 117: ...e retina See Using Presets 142 2 Viewports 9 2 5 Spotlight Report High Definition HD Spotlight Reports help you to observe changes in retinal abnormalities The Spotlight report shows a very high resol...

Страница 118: ...42 Rev A 2018 03 9 2 5 1 Spotlight Report Screen 1 2 3 Figure 30 HD Spotlight Report 12 mm 10 100X Pos Explanation 1 HD Spotlight Option Buttons 2 OCT Image and HD Spotlight Tomogram 3 Prior Scan OCT...

Страница 119: ...119 246 9 2 6 1 High Definition Images Report Screen 1 2 3 4 5 6 8 7 9 10 11 12 Figure 31 High Definition Images Report Screen Pos Name Explanation 1 Hides or displays the fundus image 2 Selects the...

Страница 120: ...atomically accurate image 11 OCT Image 12 HD Tomogram 9 3 Opening a Report or Analysis To open a report or analysis Prerequisite Patient is selected Select the Patient 74 Action 1 Click Analyze 1 2 4...

Страница 121: ...ft is the earlier scan and the right is the current scan NOTE The previous scan must be from a previous visit on a previous day not for scans taken the same day To compare scans Prerequisite Logged in...

Страница 122: ...ly include bright areas that could contain decorrelation tails or even actual vasculature The brightness and contrast of the avascular layer is enhanced in order to assist in visualizing any potential...

Страница 123: ...in to review station or instrument Logging In as Operator or Data Analyst 73 The scan report or analysis is open Opening a Report or Analysis 120 The fundus overlay is showing Hide or Show a Fundus O...

Страница 124: ...a slider appears to the right of the fundus image Move the slider up or down to display the angle slices To create a custom slice Prerequisite Logged in to review station or instrument Logging In as O...

Страница 125: ...ch between fast and slow B scans Prerequisite Logged in to review station or instrument Logging In as Operator or Data Analyst 73 The scan report or analysis is open Opening a Report or Analysis 120 A...

Страница 126: ...yst 73 The scan report or analysis is open Opening a Report or Analysis 120 The image editing toolbar for the image is open Opening Image Editing Tools 125 Action 1 Click the zoom icon A slider opens...

Страница 127: ...brightness move the slider marker down 9 4 6 5 Adjusting Image Contrast To adjust image contrast Prerequisite Logged in to review station or instrument Logging In as Operator or Data Analyst 73 The sc...

Страница 128: ...icon 2 Click on the image where you want to add text The annotation tool opens where you clicked 3 Type your annotation 4 To start a new line in an annotation click the Enter key and click OK 5 To mo...

Страница 129: ...Images You can add up to ten calipers on an image or B Scans Calipers add a line that measures microns m To add calipers to images Prerequisite Logged in to review station or instrument Logging In as...

Страница 130: ...o the measurement line The icon changes to 3 To move the caliper click on the middle of the caliper and drag it to a new location 4 To change the direction of the caliper click on an end of the calipe...

Страница 131: ...ools 125 Action 1 Click the movie icon The movie controls open 1 2 3 4 5 6 2 To start the movie click the play button 1 3 To stop the movie click the pause button 2 4 To move backward one frame click...

Страница 132: ...ysis 120 The image editing toolbar for the image is open Opening Image Editing Tools 125 Action 1 Click the export icon The export buttons appear 2 Click Save Movie A browse dialog opens 3 Navigate to...

Страница 133: ...ogged in to review station or instrument Logging In as Operator or Data Analyst 73 The scan report or analysis is open Opening a Report or Analysis 120 Logged in to review station or instrument Loggin...

Страница 134: ...ports PLEX Elite 9000 provides tools to generate reports After you review edit overlay fundus annotate and adjust the scanned images you can save and print the report or save the PDF file The options...

Страница 135: ...the report click the print icon 2 3 To export the report click the export icon 3 4 To delete the report click the trash can icon 4 9 4 7 5 1 The Print Preview Screen Reports are accessed when you sel...

Страница 136: ...dow with scan data 3 Footer containing any comments by the technician or doctor the signature of the reviewing doctor insti tution name and other report identifiers 4 Mini Toolbar NOTE Hovering over t...

Страница 137: ...cture Review screens have both vertical and horizontal slice navigators Cube Reports have only a horizontal slice navigator The horizontal blue line corresponds to the location of the fast B scan and...

Страница 138: ...ice data in planes parallel to the front of the cube or the side of the cube The X slice parallel to the front of the image is also known as the fast B scan because this is the direction in which each...

Страница 139: ...to orient you to the B scan Figure 35 Fundus Image with Overlay in Review Screen To hide or display slice navigators Prerequisite Logged in to review station or instrument Logging In as Operator or Da...

Страница 140: ...he B Scan select a triangle at the end of a segmentation line and drag the layer boundary up or down 2 To move the entire slab within the B scan click outside the B scan press SHIFT and scroll the mou...

Страница 141: ...18 03 9 4 Working with Viewport Images 2660021169042 Rev A 2018 03 141 246 2 Select and drag the blue segmentation line ILM layer or the red segmentation line RPE to adjust a boundary as shown below 3...

Страница 142: ...en you are finished press Close 9 5 Using Presets 9 5 1 About Presets Ten Presets on the left side of the Angiography Analysis screen show calculated retinal layers Presets provide a starting point fo...

Страница 143: ...Action 1 To show or hide the Presets click on the presets tab 1 9 5 3 Angiography Analysis Presets 1 2 3 4 5 6 7 8 9 10 Figure 36 Angiogrphy Analysis Presets and Boundaries Pos Name Inner Boundary Out...

Страница 144: ...of the entire retina Inner Limiting Membrane ILM Offset above the RPE fit by 70 m to minimize the contribution of the hyper reflective Retinal Pigment Epithelium RPE ZILM ZRPE ZRPE fit 70 m 3 VRI Hig...

Страница 145: ...location of the estimated IPL ZILM is the boundary location of the ILM TILM OPL is the thickness between ILM and the outer plexiform layer OPL 5 Deep IPL Outer Plexiform Layer OPL ZIPL ZOPL min RPE fi...

Страница 146: ...IB ZRPE fit 64 m ZChOB ZRPE fit 115 m 10 Whole Eye From the start position to the end position of each A scan 3 mm in depth The vasculature of entire posterior segment including retina and choroid 9 5...

Страница 147: ...iew of the retina The colors of the ILM RPE color bar represent the depth in micrometers m ranging from 0 blue to 500 white in increments of 25 m for each bar 3 VRI Highlights disorders of the VRI suc...

Страница 148: ...the IS OS Ellipsoid Zone 128 m below the RPE Fit layer 5 IS OS Ellipsoid Highlights disruptions to the IS OS Ellipsoid Zone 44 m above the RPE layer 22 m above the RPE layer Follows the RPE contour a...

Страница 149: ...putes the summation of all flow pixel values for each A line axial direction between the layers Max computes the average of the highest 5 flow pixel values for each A line axial direction between laye...

Страница 150: ...x 8 Click OK 9 6 Show or Hide the Fundus Image To hide or display the fundus image Prerequisite Logged in to review station or instrument Logging In as Operator or Data Analyst 73 The scan report or a...

Страница 151: ...or B Scan select 1 color on 7 To show a 2 color B Scan select 2 color on 8 To increase the transparency level of the B Scan move the Transparency slider right 9 To decrease the transparency level of t...

Страница 152: ...entation Results 152 246 2660021169042 Rev A 2018 03 2 Click Edit Segmentation Results The segment editor opens 3 To view a full screen image click Click again to exit full screen mode 4 Select the to...

Страница 153: ...ap slide RNFL Thickness Map to off 10 Click Save 9 9 Changing Viewport Layout To change the viewport layout Prerequisite Logged in to review station or instrument Logging In as Operator or Data Analys...

Страница 154: ...ing a Report or Analysis 154 246 2660021169042 Rev A 2018 03 2 To show a watermark on the exported images slide Show Device Watermark on 3 To omit a watermark on the exported images slide Show Device...

Страница 155: ...ments Review Stations typically have a designated primary database When data is imported it is placed into this database The option Database Selection is available on Review Stations for this purpose...

Страница 156: ...the originating clinic The device gives you the choice to export exam data without infor mation that could identify the patient Upon import anonymous or obscured patient records appear in the patient...

Страница 157: ...erge Patients The patient records are now combined for the patient under the identifier selected 10 3 3 Move Scan If a scan was acquired using an incorrect patient record you can move the scan data to...

Страница 158: ...rned 19 would now belong to the category Adult 5 Select Add to add a category to the patient s record Select Remove to remove it 6 On completion click Update and Close 10 3 5 Edit Patient Records The...

Страница 159: ...patient by last name ID or advanced search criteria 2 Add New Patient Tab Adds a new patient record 3 View Today s Patients Tab Lists patients scheduled for a scan today patients added today and patie...

Страница 160: ...Elite 9000 uses this information to determine the scan focus Each patient must have a unique patient ID for PLEX Elite 9000 to save acquired images in their record Your institution can use its own pa...

Страница 161: ...s 65 11 Click Save 12 To add another new patient click New Patient 13 Click Close 10 3 8 Finding a Worklist Patient Record DICOM NOTE Edit patient records in your EMR system if used Changes made direc...

Страница 162: ...You can set a preference that automatically searches the DICOM archive for patients scheduled for a scan today see Enabling Automatic Worklist Search DICOM 68 Prerequisite Logging In as Operator or D...

Страница 163: ...sult The patients you added are now listed in the View Today s Patients tab 10 4 Data Archiving and Retrieval Data archival is the storage backup for PLEX Elite 9000 Whenever the instrument is powered...

Страница 164: ...ollow the format ID Unique to the Instrument A YEAR MONTH DAY HOUR MINUTE SEC Thus the following archive name 123456789 A 20161130154623 would mean that the archive A had been made on machine 12345678...

Страница 165: ...n XML format Export in Native and XML format Export in IMG Export to ARI Network Hub 10 5 1 Data Export Options Export Exam Option Description Native Exports patient data in its existing format XML Ex...

Страница 166: ...img Contains the voxels of the flow scan after it has been z motion corrected Angio scans only fixation txt Contains the position of the scan relative to the fundus image LSO iris bin Contains an ima...

Страница 167: ...e 20070609081320226 Omit Patient Name Day of birthday In addition Replaces the day of birth with 1 For example the birthday 10 22 1995 becomes 10 1 1995 NOTE For patients over 80 years old the year of...

Страница 168: ...ID mode is selected Action u Select Records Export Exams The Export Exams dialog opens showing the last export path On first export Path is empty u To change the export destination click Browse and n...

Страница 169: ...the form of native files such as jpg 10 6 1 Exporting to Montage Editor Prerequisite The Analysis screen is open Action 1 Choose any one of the 5 Angio 12 x 12 scans from the Scan Selection list 2 Sel...

Страница 170: ...ions checkRemove Projections 5 Click Montage The montage is generated and displayed on the screen 6 To view the montage in full screen mode double click the montage image 7 To return to normal preview...

Страница 171: ...s For all imported patient records it is possible to import new scan data and update patient data including obscured patient records If during import the device encounters information associated with...

Страница 172: ...drive Target system login is successful If the target system requires a password for access Patient ID mode is selected Action u Select Records Import Exams The Import dialog opens u Navigate to the...

Страница 173: ...ansmission of data from to an external connection network for example Remote service activity The events are automatically recorded in up to 5 audit files of 5 Mb each When the maximum limit for files...

Страница 174: ...Empty page for your notes...

Страница 175: ...automatically or intentionally u Do not download or install any unapproved software or drivers NOTE Do not perform a virus scan while acquiring exam data NOTE These instructions assume that a TCP IP...

Страница 176: ...rom a network file server 11 2 Configuring Windows Automatic Updates CAUTION Installing non high priority updates could lead to security risks u Do not install non high priority updates driver hardwar...

Страница 177: ...u Under Important updates select Check for updates but let me choose whether to download and install them u Click OK u Click Check for updates u Deselect all non high priority driver and hardware upda...

Страница 178: ...or can view compare annotate edit them from their computer on the same network This procedure describes how map a network drive using the Windows control panel When you map a network drive from the re...

Страница 179: ...t troubleshoot or repair problems with network connectivity u Observe all guidelines in this document regarding instrument networking The PLEX Elite 9000 includes a 24TB NAS device for storing exam da...

Страница 180: ...e user s responsibility to protect their exam data from loss by frequent backup of the network server Backup media should be of archival quality and the media should be stored in a secure remote locat...

Страница 181: ...a Network Storage Device 2660021169042 Rev A 2018 03 181 246 u On the instrument select Records Archive Management Archive Locations New Archive Location u Type the path of the Network File Server For...

Страница 182: ...Empty page for your notes...

Страница 183: ...r device when not in use 12 2 Cleaning Agents Item Explanation Latex Finger Cots and Gloves Solvents are harsh to the skin wear protection Optics Cleaning Tissue Soft absorbent lint free lens tissue i...

Страница 184: ...with the optic The fold should be about as wide as the optic 2 Hold the tissue with hemostats parallel to and near the fold 3 While holding the optic using tweezers if necessary blow off any dust 4 So...

Страница 185: ...e lifted from an optical surface with soap or other wetting agent The optic is then rinsed in water and the water removed with alcohol Acetone helps speed drying and helps eliminate streaks from formi...

Страница 186: ...12 Cleaning and Disinfection Instructions for Use 2660021169042 Rev A 2018 03 12 5 Cleaning Peripherals and Table 186 246 2660021169042 Rev A 2018 03 2 Regularly dust or wipe down the System table...

Страница 187: ...u Keep the protective cover on the instrument when not in use CAUTION Improper care and cleaning of optical components could lead to coating failure Contaminants on the optical surfaces increase scat...

Страница 188: ...odule power cord and cooling fan Figure 41 Acquisition Unit Back View To remove the rear cover Action 1 Press rear cover tabs down 2 Swing the top of the cover away from the instrument 13 2 2 Fan Filt...

Страница 189: ...placed where it appears to be placed based on the fundus image 13 3 1 Installing the Verification Test Tool NOTE If the Performance Verification Check fails data acquired since the last successful che...

Страница 190: ...urn the screws clockwise on the top and bottom to secure the tool in place 13 3 1 1 Run The Performance Verification To run the Performance Check Action 1 NOTE You cannot edit or delete the Performanc...

Страница 191: ...re and then select OD or OS in the Select Eye dialog that appears The Review screen appears automatically 9 NOTE Image appearance or signal strength have no bearing on the co alignment of the scan and...

Страница 192: ...OCT Fundus is selected 14 NOTE When the blue and magenta lines are correctly centered you may find it difficult to see where they cross because the scan lines are nearly as thick as the lines that co...

Страница 193: ...he vertical and horizontal navigators to align with the cross hair target Figure 45 Align the navigators with the cross hair target 16 Click X at upper right or double click anywhere on the image to e...

Страница 194: ...ge Pass If both scan line indicators pass partially or wholly through the center of the cross hairs on both LSO and OCT Fundus images the Test passes Some examples of pass conditions are shown to the...

Страница 195: ...r 2660021169042 Rev A 2018 03 13 3 Performance Verification Check 2660021169042 Rev A 2018 03 195 246 13 3 1 3 Performance Verification Examples Examples of FAIL conditions Figure 46 OCT Fundus Fail F...

Страница 196: ...ification Check 196 246 2660021169042 Rev A 2018 03 NOTE Because no fine adjustments are required during scanning for the Performance Verification Test the slice image might be very poor This makes no...

Страница 197: ...ocus to get a clearer image of the cross hair test pattern Use the focus arrows if your system does not have Auto Focus activated Besides focus other adjustments usually are not necessary although pos...

Страница 198: ...d 14 NOTE When the blue and magenta lines are correctly centered you may find it difficult to see where they cross because the scan lines are nearly as thick as the lines that comprise the central cro...

Страница 199: ...vertical and horizontal navigators to align with the cross hair target 16 Click X at upper right or double click anywhere on the image to exit full screen mode 17 Select the Show LSO icon to the upper...

Страница 200: ...scan line indicators pass partially or wholly through the center of the cross hairs on both LSO and OCT Fundus images the Test passes Both lines centered Horizontal line marginal but OK Vertical line...

Страница 201: ...ir 2660021169042 Rev A 2018 03 13 3 Performance Verification Check 2660021169042 Rev A 2018 03 201 246 13 3 4 Performance Verification Examples Examples of FAIL conditions Figure 50 OCT Fundus Fail Fi...

Страница 202: ...ification Check 202 246 2660021169042 Rev A 2018 03 NOTE Because no fine adjustments are required during scanning for the Performance Verification Test the slice image might be very poor This makes no...

Страница 203: ...injury to personnel u Always power down the table and unplug the power cord before proceeding u At all times use the minimum force necessary to accomplish each step so as to prevent damage or injury...

Страница 204: ...ld cause damage to the table or injury to personnel u Always power down the table and unplug the power cord before proceeding u At all times use the minimum force necessary to accomplish each step so...

Страница 205: ...Maintenance and Repair 2660021169042 Rev A 2018 03 13 5 Power Table Fuse Replacement 2660021169042 Rev A 2018 03 205 246 Figure 55 Table Power Entry Module Fuse Holder Assembly Figure 56 Table Fuse H...

Страница 206: ...recommended that periodic inspection be carried out to ensure that the PLEX Elite 9000 system is well maintained and free of dust that wiring is inspected and optics are cleaned as discussed in Clean...

Страница 207: ...mponents on the table nor add non system devices or components to the table nor replace original system components with substitutes not approved by ZEISS CAUTION Improper care and cleaning of optical...

Страница 208: ...dent to the Competent Authority in the state where the user is established 14 2 Status Messages Status Compon ent Message Fault Cause Rectification Qualifi cation Hard Drive Adequate free data storage...

Страница 209: ...patient data You cannot Acquire or Analyze data u Create additional hard disk space by deleting unused saved exams u Save the exams to an external storage unit or an additional NAS u Shut down and res...

Страница 210: ...Empty page for your notes...

Страница 211: ...e Tunable Laser Center Wavelength Centered between 1040 nm 1060 nm Sweep range 980 nm 1120 nm Scan Angle 10 minimum Scan Speed 100 000 A Scans sec Operating Beam Power nominal 4 5 mW at cornea A Scan...

Страница 212: ...During OCT Scan Optical Source Super luminescent diode SLD 750 nm Optical Power 1 1 mW at the cornea nominal Field of View 36 W x 30 H Frame Rate 20 Hz Transverse Resolution 25 m in tissue Transverse...

Страница 213: ...A 2018 03 15 3 Electrical 2660021169042 Rev A 2018 03 213 246 15 3 Electrical Overall Ratings 100 V 60 Hz 8 0 A 100 V 8 0 A 50 60 Hz 120 V 8 0 A 50 60 Hz 220 V 4 0 A 50 60 Hz 240 V 4 0 A 50 60 Hz Fus...

Страница 214: ...here are three approved storage devices for PLEX Elite 9000 Storage Capacity 24 TB Number of Bays 4 Interface USB 3 0 ports 2 USB 2 0 port 1 eSATA port 1 Network connectivity Gigabit Ethernet 10 100 E...

Страница 215: ...tructions for Use 15 Specifications 2660021169042 Rev A 2018 03 15 4 Mechanical 2660021169042 Rev A 2018 03 215 246 15 4 3 DLink DGS 1008 Switch Number of Ports Gb Ethernet 8 Data Transfer Rate 2000 M...

Страница 216: ...t Unit Value Weight kg Ib Complete System Total Weight 105 1 209 6 incl Power Table Total Load 45 1 99 6 comprises Patient Module 22 7 50 Computer 14 5 32 Monitor 5 4 12 NAS 2 03 4 5 Switch 5 1 1 Dime...

Страница 217: ...ions Unit Value Temperature C 10 to 55 Relative humidity non condensing 10 to 95 Atmospheric pressure hPa 700 to 1060 15 5 3 Transport Conditions Unit Value Temperature C 40 to 70 Relative humidity no...

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Страница 219: ...e License fee which is part of the price You paid for Your PLEX Elite 9000 and Your agreement to abide by the terms and conditions of this License ZEISS grants to You a non exclusive non transferable...

Страница 220: ...hat 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 failure to abide by the...

Страница 221: ...ories authorized by ZEISS u In the U S call 800 341 6968 Outside the U S contact your local Zeiss distributor You can find the ZEISS contact partner for your country on our website www zeiss com 17 2...

Страница 222: ...umber varies depending on your area of operation Use the procedure that has been established by Carl Zeiss Meditec for your area of operations 17 5 International Service Operations Customers are bille...

Страница 223: ...es 2660100006566 Camera Lens Cleaner 2660100007672 Camera Lens Wipes 2660100007673 17 6 4 Kit Test Eye Designation Specification Part Number The Kit includes Verification Test Tool Fixation Device Occ...

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Страница 225: ...ing Decommissioning CAUTION Attempting to decommission your system may result in damaged equipment and danger to personnel u Never attempt to decommission a ZEISS system or device Only ZEISS approved...

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Страница 227: ...9 1 Safety During Packaging and Transport CAUTION Packaging and transport by non ZEISS personnel could result in damage loss or non compliance within the country of transit u Allow only change to Zeis...

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Страница 229: ...tronic components with integrated batteries Dispose of the device and integrated batteries correctly in accordance with national legislation The device specified on the delivery note must not be dispo...

Страница 230: ...Empty page for your notes...

Страница 231: ...m fundus image with twice the resolution of our standard tracker The increased resolution allows for more precise motion correction helping reduce magnitude of artifacts present on the en face angiogr...

Страница 232: ...t data and images from the instrument for analysis RPE Retinal Pigment Epithelium the pigmented cell layer just outside the neurosensory retina that nourishes retinal visual cells and is firmly attach...

Страница 233: ...Instructions for Use Index 2660021169042 Rev A 2018 03 2660021169042 Rev A 2018 03 233 246 Index...

Страница 234: ...Acquire 85 Angiography Anlaysis Report 110 En Face Report 114 Quality Check 98 Repeat Prior Scan 96 15 x 9 Montage Angio About 82 Acquire 91 Angiography Anlaysis Report 110 En Face Report 114 Quality...

Страница 235: ...yst Profile Demographic 31 Occupational Skills 31 Analyze Button 45 Angio Images Show or Hide 153 Angio Scans Analysis and Reports 107 Methodology 81 Angle Spotlight 88 Annotations Adding Calipers 129...

Страница 236: ...B Scans Edit 150 Comparison Button 109 Computer 37 Configuration Settings Initial Configuration Required 57 Instrument Identifeir 61 Contrast Resetting 131 Contrast Adjusting 127 Copyright Software 21...

Страница 237: ...23 Voltage fluctuations flicker emissions IEC 61000 3 3 23 Electromagnetic Immunity Electrical fast transient burst IEC 61000 4 4 23 Guidance and manufacturer s declaration 23 25 IEC 61000 4 11 24 IEC...

Страница 238: ...ndus Image B Scan Image 153 OU Cube Scans 116 Show or Hide 150 151 Fundus Image Button 119 Fundus Viewport 84 G Global Presets Creating 149 Gray Scale B Scans Edit 150 H Hardware 214 Hardware Overview...

Страница 239: ...ponents 37 Head Rest 38 Imaging Aperture 38 Motorized Patient Alignment Unit 38 Port for External Fixation Arm 38 Instrument ID Editing 61 Instrument Information Model Sequence Serial Number 61 Intend...

Страница 240: ...twork File Server Requirements 179 Networking 175 Guidelines 21 Prohibited Activity 22 Notes Add to Image 128 Notification of Serious Incident 28 O Obscured Patient Records 156 Obsuring Patient Identi...

Страница 241: ...134 Performance Verification Check 189 Failure 189 Pass Fail Conditions 194 200 Procedure 190 197 Test Tool 189 Peripherals Monitor Mouse Keyboard 37 Physician Delete 64 Edit 64 Instructions 72 Pixel...

Страница 242: ...structions 50 Review Station System Requirements 49 Review Types 107 Review Results Screen Save to csv 133 Rotate Caliper 130 RPE 144 S Safety Cleaning the Instrument 183 Electrical 19 Installation 47...

Страница 243: ...9 Angle and Length 88 Report 117 Reports 107 SS OCT Technology 33 Staff Delete 64 Standard Button 120 Startup Power On Off 55 Sequence 55 Status 45 Green 45 Red 45 Yellow 45 Structure Images Show or H...

Страница 244: ...44 246 2660021169042 Rev A 2018 03 W Warnings Definition 10 Hardware Installation and Setup 47 Watermark On Off 153 Whole Eye Preset 146 Windows automatic updates 176 Workstation PC 37 X XML Export 16...

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Страница 246: ...ermany Toll Free 1 800 341 6968 Phone 49 36 41 22 03 33 Phone 1 925 557 4100 Fax 49 36 41 22 01 12 PLEX Elite 9000 User Manual Fax 1 925 557 4101 info meditec zeiss com Specifications subject to chang...

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