Zeiss CLARUS 500 Instructions For Use Manual
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Zeiss CLARUS 500 Instructions For Use Manual

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CLARUS 500
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  • Page 1 CLARUS 500 Instructions for Use...
  • Page 2 © 2017, Carl Zeiss Meditec, Dublin, CA Trademarks All Zeiss products mentioned herein are either registered trade- marks or trademarks of Carl Zeiss Meditec, Inc. in the United States and/or other countries. Windows, Windows Media, Windows Server, and Microsoft are ei- ther registered trademarks or trademarks of Microsoft Corporation in the United States and/or other countries.

  • Page 3: Table Of Contents

    Instructions for Use Table of Contents CLARUS 500 Table of Contents Safety and Certifications ................ 7 Compliance........................... 7 1.1.1 Laser Safety and Compliance ...................... 7 1.1.2 Optical Safety ............................ 7 1.1.3 RoHS Compliance .......................... 7 1.1.4 Electrical Safety .......................... 8 Symbols and Labels ...................... 8 Warnings, Cautions, and Notes .................. 10 1.3.1...
  • Page 4 Table of Contents Instructions for Use CLARUS 500 3.2.1 Installing Review Software....................... 34 3.2.2 Upgrading Instrument and Review Software.................. 37 Daily Startup .................... 39 Turn on the Instrument ...................... 39 Logging In .......................... 40 Operation .................... 41 Safety During Operation ..................... 41 Managing Data........................ 41 5.2.1 Manage Patient Records........................ 41...
  • Page 5 Instructions for Use Table of Contents CLARUS 500 Configuring Local Settings.................... 99 Setting All Options ...................... 100 Configuring Report Settings ..................... 100 Configuring Printers ...................... 101 Configuring Acquisition Settings .................. 102 Configuring Security Settings ................... 103 Configure Capture Settings.................... 104 Configuring Import and Export.................. 104 Configure a Stand-Alone Instrument ................ 105 6.10...
  • Page 6 Table of Contents Instructions for Use CLARUS 500 10.1 Electrical Specifications .................... 119 10.2 Instrument Specifications .................... 119 10.2.1 At-Instrument Computer Specifications .................. 119 10.3 Dimensions and Weight.................... 120 10.4 Ambient Requirements for Operation................ 120 10.5 Ambient Requirements for Storage .................. 120 10.6 Ambient Requirements for Transport ................ 120 10.7...

  • Page 7: Safety And Certifications

    1.1 Compliance CLARUS™ 500 is compliant with ISO 10940:2009 and ISO 15004-1:2006. 1.1.1 Laser Safety and Compliance 1.1.2 Optical Safety CLARUS 500 is compliant with the following optical safety stan- dards: • IEC 60825-1 • ANSI Z80.36 • ISO 15004-2 •...

  • Page 8: Electrical Safety

    1 Safety and Certifications Instructions for Use 1.2 Symbols and Labels CLARUS 500 1.1.4 Electrical Safety Electrical Safety Class I Equipment - Protection against electrical shock (per IEC 60601-1). 1.2 Symbols and Labels Symbol Meaning Warning Caution Note Electricity Must follow Instructions for Use...
  • Page 9 Instructions for Use 1 Safety and Certifications CLARUS 500 1.2 Symbols and Labels Symbol Meaning Serial Number Catalog Number/Part Number Model Number Certification mark of CSA – Nationally Recognized Test- ing Laboratory for US and Canada Disposal of the Product within the E.U. Do not dispose via domestic waste disposal system or communal waste disposal facility.

  • Page 10: Warnings, Cautions, And Notes

    These are actions that can be taken to prevent the hazard. 1.3.2 Warnings Opening the device covers WARNING! may result in injury. Only ZEISS authorized service technicians may remove device covers. Tipping the device WARNING! may result in injury. Do not allow the patient to lean on the table or use it as a sup- port to stand up.
  • Page 11 Use only accessories authorized by ZEISS. 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. Class 3B laser radiation WARNING! when open.

  • Page 12: Cautions

    Read the user documentation. Follow directions carefully. Do not make upgrades, or carry out repairs or modifications, without specific guidance and instruction from ZEISS or an au- thorized ZEISS represenative. Improper cleaning CAUTION! may result in inadequately disinfected equipment.
  • Page 13 Device warranty, result in damage to the instrument and/or compromise safety for patients and operators. The CLARUS 500 has special EMC precaution requirements and needs to be installed and put into service according to the EMC information provided herein.

  • Page 14: Notes

    Otherwise, degradation of the performance of this equipment could result. The CLARUS 500 is intended for use in a professional health- CAUTION! care facility environment. Using the instrument in any other environment may void the war- ranty and compromises the safety of the patient and/or operator.

  • Page 15: Report Serious Accidents

    1.5 Essential Performance The main clinical performance of the CLARUS 500 is to capture, dis- play and store images to aid in the diagnosis and monitoring of dis- eases and disorders occurring in the retina, ocular surface and visi- ble adnexa.

  • Page 16: Electromagnetic Emissions

    The user might need to take mitigation measures, such as relo- cating or re-orienting the equipment. 1.6.1 Electromagnetic Emissions The CLARUS 500 complies with the following emission require- ments: Phenomenon Standard Conducted and radiated RF emis-...

  • Page 17: Electromagnetic Immunity

    Instructions for Use 1 Safety and Certifications CLARUS 500 1.6 Electromagnetic Compatibility (EMC) 1.6.2 Electromagnetic Immunity The CLARUS 500 complies with the following immunity require- ments: Phenomenon Basic EMC standard or test Immunity test levels method Electrostatic Discharge IEC 61000-4-2 ±...
  • Page 18 1 Safety and Certifications Instructions for Use 1.6 Electromagnetic Compatibility (EMC) CLARUS 500 Test Fre- Band (MHz) Service Modulation Maximum Distance (m) Immunity quency (MHz) power (W) Test Level (V/ 704 - 787 LTE Band 13, Pulse 217 Hz 800 - 960...

  • Page 19: Introduction

    2.2 Usage The CLARUS 500 is designed for continuous use in a professional healthcare facility environment. Also see about this 2 Safety and Certifications [} 7] 2.3 Intended Audience...

  • Page 20: Data Analyst Profile

    2 Introduction Instructions for Use 2.4 User Documentation CLARUS 500 • Knowledge of how to capture fundus images • Experience managing patients • Experience with the Microsoft Windows operating system and applications based on it 2.3.3 Data Analyst Profile Operators who analyze the results of patient scans should have the following additional qualifications.

  • Page 21: Questions And Comments

    ZEISS representative. 2.6 System Overview 2.6.1 System Description CLARUS 500 is a non-contact, high-resolution imaging device for in vivo imaging of the human retina. Imaging modes include: • True color reflectance imaging • Infrared reflectance imaging (IR) •...

  • Page 22: Hardware Overview

    – Montaged images: 2-6 widefield images stitched into a single, combined retina image. 2.6.2 Hardware Overview The CLARUS 500 is connected to the All-in-One PC using cables mounted under the table. The operator controls the instrument and software using the instrument joystick, the All-in-One PC touch- screen, wireless keyboard and touchpad.
  • Page 23 Instructions for Use 2 Introduction CLARUS 500 2.6 System Overview 2.6.2.1 System Hardware Figure 1: System Hardware CLARUS 500 Acquisition De- All-in-One PC vice Pivoting Rack Touchpad Keyboard Joystick 2660021165005 Rev. A 2017-08 23 / 144...
  • Page 24 2 Introduction Instructions for Use 2.6 System Overview CLARUS 500 2.6.2.2 Patient View Figure 2: Patient View Forehead rest Helps keep the patient's head steady and in place Front lens Aperture for image acquisition Chin rest Positions the patient's head at the correct...
  • Page 25 Instructions for Use 2 Introduction CLARUS 500 2.6 System Overview 2.6.2.3 Operator Controls Figure 3: Operator Controls Focus knob Manually adjusts the focus Friction knob Tightens or loosens the swivel movement of the acquisition head Cross-table lock Locks the cross-table so that the acquisition...

  • Page 26: Software Overview

    • The operator needs to direct a patient's gaze to a position that cannot be obtained using internal fixation. 2.6.3 Software Overview The CLARUS 500 software includes three distinct areas: Patient, Acquire, and Analyze windows. All windows use the same top toolbar.
  • Page 27 Instructions for Use 2 Introduction CLARUS 500 2.6 System Overview Pos. Symbol Explanation Quickly hides the screen for patient privacy Opens notification volume control Opens the Settings to configure the instrument and set your preferences Minimizes the application on the computer's desktop.
  • Page 28 2 Introduction Instructions for Use 2.6 System Overview CLARUS 500 Pos. Name Explanation Acquire Opens the Acquire window allowing you to acquire new scans for the selected patient Analyze Opens the Analyze window allowing you to analyze scans and pre-...
  • Page 29 Instructions for Use 2 Introduction CLARUS 500 2.6 System Overview Pos. Name Explanation Alignment preview A visual aid for aligning the instrument with the patient's pupil Live IR preview Displays a real-time preview image prior to capture and a quality...
  • Page 30 2 Introduction Instructions for Use 2.6 System Overview CLARUS 500 Figure 8: Analyze Window - Proof Pos. Name Explanation Patient data Displays information about the currently selected patient Favorites Flags selected image(s) with a yellow start for easy identifiication Laterality filter...
  • Page 31 Instructions for Use 2 Introduction CLARUS 500 2.6 System Overview 2.6.3.5 Analyze Window - Review Figure 9: Analyze Window - Review Pos. Name Explanation Number of viewports Controls how many viewports are in the main display area Zoom Opens the zoom slider...

  • Page 32: Networking Overview

    CLARUS 500 2.6.4 Networking Overview CLARUS 500 can run as a standalone instrument storing patient and exam data locally, or it can be connected to a network server or EMR system to share data and worklists in a central location.

  • Page 33: Installation

    • the device's ventilation openings are not blocked • the device is not exposed to water or other liquids Do not modify the instrument or use cables not provided by ZEISS. 3.1.2 Installing the Instrument Refer to the Installation Instructions for complete installation in- structions.

  • Page 34: Installing Review Software

    þ You know whether this installation will use Remote Desktop Services. Action 1. Insert the software media into the review station computer's USB drive. 2. In the CLARUS 500 software folder, double-click on setup.exe. ð A confirmation opens. 3. Click Next. 4. Accept the license agreement, then click Next.
  • Page 35 Instructions for Use 3 Installation CLARUS 500 3.2 Software Installation 5. Type the user name and organization name and click Next. 6. Select Review Software, then click Next. 7. If you want to choose a different destination folder for the re- view software, click Change...
  • Page 36 3 Installation Instructions for Use 3.2 Software Installation CLARUS 500 8. Click Next. 9. If this review software will use Remote Destop Services, check Remote Desktop services will be used. 10. Click Next. 36 / 144 2660021165005 Rev. A 2017-08...

  • Page 37: Upgrading Instrument And Review Software

    Instructions for Use 3 Installation CLARUS 500 3.2 Software Installation 11. Click Install. 12. If your system prompts you to confirm changes on the com- puter, click Yes. ð Review software installation begins. Installation takes sev- eral mintues to complete.
  • Page 38 CLARUS 500 2. Confirm that you would like to continue. ü The software installs and the system reboots. Result When you upgrade instrument or review software,CLARUS 500 re- tains stored information including: • Logins and Passwords • Patient Data • Exam Data 38 / 144 2660021165005 Rev.

  • Page 39: Daily Startup

    Make sure the instrument has completed its system checks be- fore you unplug or remove power. Each time you turn on the CLARUS 500, system diagnostics checks that the system initialzed correctly and is running properly. If the di- agnosic check detects any problems, an error or alert message dis- plays.

  • Page 40: Logging In

    4 Daily Startup Instructions for Use 4.2 Logging In CLARUS 500 4.2 Logging In After the system boots up and the passes the system check upon startup and when a user logs off, the login screen opens. An Administrator must add a user's name and password be- NOTE fore that user can log in.

  • Page 41: Operation

    • Different ID or Issuer of ID: A new patient record is generated. Some EMR systems allow records that are missing key identifying information. The CLARUS 500 automatically adds the default "Un- known" if the name is missing, but rejects records that do not have a Patient ID or date of birth.
  • Page 42 5 Operation Instructions for Use 5.2 Managing Data CLARUS 500 2. Type the patient's name, gender and date of birth. 3. Type the patient's Refractive Error information (optional). 4. Select the patient's Eye Color (optional). 5. To acquire a scan, click Acquire.
  • Page 43 Instructions for Use 5 Operation CLARUS 500 5.2 Managing Data 7. Enter a reason for the merge, then select Merge again. ð The exam data from the duplicate patient record is added to the original patient record. 5.2.1.3 Reassigning Test Data...
  • Page 44 5 Operation Instructions for Use 5.2 Managing Data CLARUS 500 Action 1. In the Patient window, select the patient name and click on the down arrow and select Delete. ð A confirmation opens. 2. Click Delete. 5.2.1.5 Manually Correcting Laterality You can change the laterality of an image after it is saved using the Acquire, Review, or Proof Sheet screen.
  • Page 45 Instructions for Use 5 Operation CLARUS 500 5.2 Managing Data 1. Insert the removable media into the USB port. 2. Click Settings > Specific Settings. Action ð The Specific Settings window opens. 3. Click Import. 4. Click Import... and navigate to the file stored on the external removable media device.
  • Page 46 5 Operation Instructions for Use 5.2 Managing Data CLARUS 500 • In the Proofsheet or Review screen, select an image and right-click. • In the Proofsheet screen, select multiple images and right- click. • Export all of a patient's data; select Settings > Specific Set- tings >...

  • Page 47: Manage Users

    Instructions for Use 5 Operation CLARUS 500 5.2 Managing Data 5. Navigate to the folder you want to use for export and click Se- lect. ð A progress bar appears until export is complete. 6. Click OK. ð The data exports and a confirmation opens.
  • Page 48 5 Operation Instructions for Use 5.2 Managing Data CLARUS 500 Delete a local patient record Change Settings Reset other user's pass- words Add or delete Operators or Doctors Export log files Add or delete Administrators Table 2: Permissions Levels 5.2.2.2 Adding a New User Only Administrators can complete this task.
  • Page 49 Instructions for Use 5 Operation CLARUS 500 5.2 Managing Data 5.2.2.3 Deleting a User Only Administrators can complete this task. NOTE 1. Click Settings > User Management. Action 2. Select the Login name for the user you want to delete.

  • Page 50: Manage Backups

    ü Your password is now changed to the new password. Result 5.2.3 Manage Backups On the CLARUS 500, you can enable data backup each time the system shuts down (Configuring Automatic Backups [} 51]). You can also back up data manually at any time (Backing Up Data Man- ually [} 51]).
  • Page 51 Instructions for Use 5 Operation CLARUS 500 5.2 Managing Data 5.2.3.1 Configuring Automatic Backups You can save a backup copy of selected data at any time. You can save this data on removable media for import into other applica- tions.

  • Page 52: Log Files

    5.2.3.3 Restoring Data from a Backup Only Administrators can complete this task. NOTE If the CLARUS 500 has automatic backups enabled or if there is a saved manual backup, you can restore the system with the data from the backup file.

  • Page 53: Preparing The Device

    For complete instructions on cleaning the lens, refer to: Cleaning and Disinfection [} 109] 5.4.1 Dilating the Patient’s Eyes (Optional) The minimum pupil size for the CLARUS 500 is 2.5 mm, which is typically achieved without dilation. 5.4.2 Selecting the Patient Finding a patient's name can vary depending on the systems you use.

  • Page 54: Positioning The Patient

    5 Operation Instructions for Use 5.4 Preparing the Patient CLARUS 500 • If you use an EMR system: – The patient's name might be listed under Today – If the patient is not listed under Today, click All to scroll through the list or Search for their name or ID (See Finding a Patient [} 54]).
  • Page 55 Instructions for Use 5 Operation CLARUS 500 5.4 Preparing the Patient 2. Ask the patient to: Sit comfortably with feet flat on the ground. Lean forward slightly, grasping the table handles if needed for stability. Rest their chin in the chinrest.
  • Page 56 5 Operation Instructions for Use 5.4 Preparing the Patient CLARUS 500 4. Swing the acquisition head left to align with the patient's right eye or right to align with the patient's left eye. 56 / 144 2660021165005 Rev. A 2017-08...

  • Page 57: Aligning And Focusing On The Patient's Eye

    Instructions for Use 5 Operation CLARUS 500 5.4 Preparing the Patient 5.4.4 Aligning and Focusing on the Patient's Eye In addition to the preview image, two images of the iris help to align the eye. The top iris image is used for vertical alignment. The height of the band is the minimum pupil size required.
  • Page 58 5 Operation Instructions for Use 5.4 Preparing the Patient CLARUS 500 ð When the pupil is aligned, a live view of the fundus appears in the live IR preview window. Ensure that the image is in focus. If needed, manually focus the image (Manually Focusing the Image [} 59]).
  • Page 59 Instructions for Use 5 Operation CLARUS 500 5.4 Preparing the Patient 5.4.4.1 Manually Focusing the Image þ You reached the focus step in a Scan Acquisition task. Prerequisite þ You want to manually focus the image. Action Uncheck Autofocus. Turn the focus knob on the acquisition head (1) or use (+ and - ) (2) or the focus slider (3) on the screen to manually adjust fo- cus.

  • Page 60: Acquire Images

    5 Operation Instructions for Use 5.5 Acquire Images CLARUS 500 5.5 Acquire Images 5.5.1 Acquisition Options 5.5.1.1 Field of View Options Pos. Description Example Widefield (WF) Single image, 133° wide by 133° high 60 / 144 2660021165005 Rev. A 2017-08...
  • Page 61 Instructions for Use 5 Operation CLARUS 500 5.5 Acquire Images Pos. Description Example Ultra-Widefield (UWF) Two image montage, 200° wide by 133° high Auto Montage Four image montage, 200° wide by 200° high 2660021165005 Rev. A 2017-08 61 / 144...
  • Page 62 5 Operation Instructions for Use 5.5 Acquire Images CLARUS 500 Pos. Description Example Montage Up to six images montaged in an opera- tor-selected configuration 62 / 144 2660021165005 Rev. A 2017-08...
  • Page 63 Instructions for Use 5 Operation CLARUS 500 5.5 Acquire Images 5.5.1.2 Scan Types NOTE! Example images shown below are taken from scans acquired from multiple subjects. Pos. Description Explanation Example Color Color High resolution, color images of the fundus appear similar in color to direct observation (ophthalmoscopy).
  • Page 64 5 Operation Instructions for Use 5.5 Acquire Images CLARUS 500 Pos. Description Explanation Example Blue Channel Red Channel Green Channel 64 / 144 2660021165005 Rev. A 2017-08...
  • Page 65 Instructions for Use 5 Operation CLARUS 500 5.5 Acquire Images Pos. Description Explanation Example Infrared reflectance Infrared light is used to capture these images, with the unique prop- erty of increased pene- tration through tissue, providing improved vi- sualization of choroidal structures.

  • Page 66: Blinking The Fixation Target

    5 Operation Instructions for Use 5.5 Acquire Images CLARUS 500 • Superior • Inferior • Superotemporal • Superonasal • Inferonasal • Inferotemporal You can override the preset fixation targets and choose any loca- tion within the patient's field of view (See Manually Positioning the Internal Fixation Target [} 66].)

  • Page 67: Capturing A Widefield Image

    5.5.4 Capturing a Widefield Image Figure 11: Widefield Fixation Tar- Figure 12: WF Image Example When you capture a widefield (WF) image, CLARUS 500 takes one image and with a fixation target preset near the center. If the patient cannot see the fixation target, you can: •...
  • Page 68 5 Operation Instructions for Use 5.5 Acquire Images CLARUS 500 Prerequisite þ The device is prepared. (See Preparing the Device [} 53].) þ The patient is prepared. (See Preparing the Patient [} 53].) Action Under Scans, select WF. Select the Scan Type (Color, IR, FAF-Green, or FAF-Blue). For more information about Scan Types, refer to: Scan Types [} 63].

  • Page 69: Capturing An Ultra Widefield Image (2-Image Montage)

    Figure 13: UWF Fixation Targets Figure 14: UWF Image Example When you capture an Ultra Widefield (UWF) image, CLARUS 500 takes two widefield images and stiches them together for a wider view of the retina. The fixation targets for these images are preset at temoral and nasal.
  • Page 70 5 Operation Instructions for Use 5.5 Acquire Images CLARUS 500 Instruct the patient to blink and then open their eyes wide. Click the joystick button or click Capture. ð A preview of the captured image appears for several sec- onds and is added to the selection bin.

  • Page 71: Capturing An Automontage Image (4-Image Montage)

    • Use the external fixation target: Using the External Fixation Tar- get [} 77] If you do not complete all four scans, CLARUS 500 saves the com- pleted scans as individual wide field scans. þ The device is prepared. (See Preparing the Device [} 53].) Prerequisite þ...
  • Page 72 5 Operation Instructions for Use 5.5 Acquire Images CLARUS 500 Instruct the patient to blink and then open their eyes wide. Click the joystick button or click Capture. ð A preview of the captured image appears for several sec- onds and is added to the selection bin.

  • Page 73: Capturing A Montage Image (2-6 Image Custom Montage)

    Figure 16: Custom Montage Example Figure 17: Custom Montage Example When you capture a custom Montage image, CLARUS 500 takes a series of widefield images and stiches them together. You can de- cided how many images to include in the montage. For each im-...
  • Page 74 5 Operation Instructions for Use 5.5 Acquire Images CLARUS 500 Select the Scan Type (Color, IR, FAF-Green, or FAF-Blue). For more information about Scan Types, refer to: Scan Types [} 63]. Under Settings, select Myd if the patient's pupil is dilated and Non Myd if the patient's pupil is not dilated.

  • Page 75: Capturing A Stereo Image

    Instructions for Use 5 Operation CLARUS 500 5.5 Acquire Images Repeat Next scan steps for each scan in the series (2-6 total). 5.5.8 Capturing a Stereo Image A stereo image is comprised of two separate images of the same eye, offset to produce a stereoscopic pair.
  • Page 76 5 Operation Instructions for Use 5.5 Acquire Images CLARUS 500 The instrument automatically focuses the image. To manually adjust focus, refer to: Manually Focusing the Image [} 59]. Instruct the patient to blink and then open their eyes wide. Click the joystick button or click Capture.

  • Page 77: Capturing An External Eye Image

    Instructions for Use 5 Operation CLARUS 500 5.5 Acquire Images 5.5.9 Capturing an External Eye Image Capturing external eye images allows you to store a photograph of the eye along with the retinal images. You do not need to align the pupil or select a scan type for external image scans.

  • Page 78: Checking Scan Quality

    5 Operation Instructions for Use 5.5 Acquire Images CLARUS 500 2. Install the external fixation target (1) onto mount (2) on the pa- tient support (3). 3. Position the target where you want the patient to focus. 5.5.11 Checking Scan Quality Once data acquisition is complete, scans must be reviewed for ac- ceptance prior to being released for analysis.

  • Page 79: Analyze Images

    Instructions for Use 5 Operation CLARUS 500 5.6 Analyze Images Action 1. In the selection bin, locate the image you want to recapture. 2. Click on the X (1) to delete the image. ð A confirmation opens. 3. To delete and recapture the image, click Delete & Recapture.

  • Page 80: Proof

    5 Operation Instructions for Use 5.6 Analyze Images CLARUS 500 5.6.1 Proof Proof shows an overview of all images for the patient. Using the Proof Sheet, you can filter images by scan type, date of acquisition, laterality and favorite status.

  • Page 81: Selecting And Sorting Images

    Instructions for Use 5 Operation CLARUS 500 5.6 Analyze Images 2. Click Analyze. 5.6.4 Selecting and Sorting Images Proof allows you to find and select images you want to include in Review. To find the images to include in the Review, you can sort and filter in the following ways: •...

  • Page 82: Editing Scanned Images

    5 Operation Instructions for Use 5.6 Analyze Images CLARUS 500 2. To mark an image as a favorite, click on the image's star in the view panel. ð The star turns yellow. 3. To view only images marked as favorites, click Favorites (2).
  • Page 83 Instructions for Use 5 Operation CLARUS 500 5.6 Analyze Images 5.6.5.2 Zooming In or Out þ The Analyze window is open (Opening the Analyze Window Prerequisite [} 80]). 1. Select the image you want to adjust. ð The selected image is outlined in blue.
  • Page 84 5 Operation Instructions for Use 5.6 Analyze Images CLARUS 500 Symbol Name Explanation Freehand Draws a freehand shape and adds the area enclosed by the shape (in ) to the image Circle Adds a circle and its area (in mm...
  • Page 85 Instructions for Use 5 Operation CLARUS 500 5.6 Analyze Images 3. Type your text annotation. 4. If you want an arrow to appear with the text, click Show Ar- row. 5. Click OK. 6. Close the annotations panel. ü The text annotation appears on the image.
  • Page 86 5 Operation Instructions for Use 5.6 Analyze Images CLARUS 500 3. Touch or right-click at the appropriate starting point and drag to the area you want the arrow to point. 4. Close the annotations panel. ü The arrow appears on the image.
  • Page 87 Instructions for Use 5 Operation CLARUS 500 5.6 Analyze Images 3. Close the annotations panel. ü When you finish drawing the caliper line, the review soft- Result ware calculates its length. 5.6.5.3.5 Circling an Area of an Image þ The Analyze window is open (Opening the Analyze Window Prerequisite [} 80]).
  • Page 88 5 Operation Instructions for Use 5.6 Analyze Images CLARUS 500 3. Close the annotations panel. ü When you finish drawing the circle, the review software cal- Result culates the area. 5.6.5.3.6 Drawing a Freehand Shape in an Image The Freehand tool allows you to draw any shapes around findings you want to emphasize.
  • Page 89 Instructions for Use 5 Operation CLARUS 500 5.6 Analyze Images ð When you connect to the starting point, the review soft- ware calculates the area of your shape. 3. Close the annotations panel. 5.6.5.3.7 Copying and Pasting Annotations Copy Annotation registers the images to each other in order NOTE to copy to the appropriate location.
  • Page 90 5 Operation Instructions for Use 5.6 Analyze Images CLARUS 500 ð The copy & paste annotations panel opens showing thumb- Action nails of the selected images. The thumbnails in the panel are in the same configuration as the larger images in Pre- view.
  • Page 91 Instructions for Use 5 Operation CLARUS 500 5.6 Analyze Images 4. Click Copy. ð The annotations appear on both images. 5. Close the annotations panel. 5.6.5.3.8 Hiding Annotations in an Image Hide All temporarily hides all annotations on the image allowing you to see the original image only.
  • Page 92 5 Operation Instructions for Use 5.6 Analyze Images CLARUS 500 3. To view the annotations again, uncheck Hide All. 4. Close the annotations panel. 5.6.5.3.9 Deleting Annotations You can select any annotation from the image or select multiple annotations and delete them together.
  • Page 93 Instructions for Use 5 Operation CLARUS 500 5.6 Analyze Images 3. Adjust the settings until the image enhanced as you want to save it. 4. Close the brightness adjustment panel. 5.6.5.5 Adjusting Image Color Tones þ The Analyze window is open (Opening the Analyze Window Prerequisite [} 80]).

  • Page 94: Manually Creating A Montage

    5 Operation Instructions for Use 5.6 Analyze Images CLARUS 500 5.6.6 Manually Creating a Montage You can select from two to six images of the same eye to create a montage image. þ The Analyze > Review screen is open.

  • Page 95: Saving Edited Images

    Instructions for Use 5 Operation CLARUS 500 5.6 Analyze Images When Stereo Mode is selected, all non-stereo images are filtered out of the selection bin and only 2-up and 4-up viewing options are available for viewing the selected Stereo pairs.

  • Page 96: Shutdown

    5.7.2 Shutting Down Each time you shut down the system, all shutdown activity com- pletes (if set) and CLARUS 500 retains a log of the actions com- pleted. Activities that can be set to run each time the system shuts down include: •...
  • Page 97 Instructions for Use 5 Operation CLARUS 500 5.7 Shutdown Action 1. To exit the application, click on the X in the upper right corner. 2. Turn off the power switch on the instrument. 3. Press the power button on the computer.
  • Page 98 Empty page, for your notes...

  • Page 99: Configuration

    Instructions for Use 6 Configuration CLARUS 500 6.1 Configuring Local Settings 6 Configuration 6.1 Configuring Local Settings Local settings include information about your clinic such as address, local language and local time zone. þ Settings are open. Prerequisite Action 1. Select General Settings.

  • Page 100: Setting All Options

    10. If your language requires Multi-Component Names, Enable Multi component names and select the appropriate type. 6.2 Setting All Options CLARUS 500 has an options wizard for initial settings that you can also use for checking or resetting options. Only Administrators can complete this task.

  • Page 101: Configuring Printers

    Instructions for Use 6 Configuration CLARUS 500 6.4 Configuring Printers 3. To enable a signature field on reports, slide Signature field on reports to Show. 4. To add a logo to reports, click Browse... next to Report logo and navigate to the logo file and select it.

  • Page 102: Configuring Acquisition Settings

    6 Configuration Instructions for Use 6.5 Configuring Acquisition Settings CLARUS 500 4. To add a printer, click Add printer and select the printer. 5. To edit a printer, select the printer and click Edit. 6. To delete a printer, select the printer and click Delete.

  • Page 103: Configuring Security Settings

    Instructions for Use 6 Configuration CLARUS 500 6.6 Configuring Security Settings 2. Click Acquisition. 6.6 Configuring Security Settings The User management screen offers the following security set- tings: Setting Explanation Login without specify- Sets whether user login is required. This setting...

  • Page 104: Configure Capture Settings

    6 Configuration Instructions for Use 6.7 Configure Capture Settings CLARUS 500 Unprotected devices NOTE may be at risk from unauthorized individuals. Select and set the Password strength setting in the User man- agement screen. 6.7 Configure Capture Settings Select the Acquisition button on the Specific Settings tab to con- figure acquisition settings.

  • Page 105: Configure A Stand-Alone Instrument

    Auto import file If this setting is on, files in the configured folder are automatically imported Select auto import Sets the location where the CLARUS 500 soft- folder path ware will automatically look for files to import 6.9 Configure a Stand-Alone Instrument...

  • Page 106: Connecting To A Wireless Printer

    6.12 Connecting to a Wireless Printer Connect only to wireless printers recommended). NOTE Only Administratorsand Doctors can complete this task. NOTE þ The CLARUS 500 and printer are on. Prerequisite þ The printer is configured correctly. þ Settings are open. Action 1.

  • Page 107: Connecting To A Lan

    5. To view the properites of the printer, click Properties. 6.13 Connecting to a LAN þ The CLARUS 500 must be connected to the local network using Prerequisite a network cable. Be gentle with the connector when plugging it into the CLARUS 500 ethernet port.

  • Page 108: Data Storage

    To disconnect a network drive, select the drive, then click Unmap. 6.14 Data Storage The CLARUS 500 includes a some storage space on its PC. If you need additional data storage capacity, add external networked storage devices as requried.

  • Page 109: Cleaning And Disinfection

    Instructions for Use 7 Cleaning and Disinfection CLARUS 500 7.1 Safety During Cleaning 7 Cleaning and Disinfection 7.1 Safety During Cleaning Cleaning lenses too frequently CAUTION! can damage optic surfaces. Clean optics only when necessary. Keep the protective cover on the instrument when not in use.

  • Page 110: Removing Severe Contamination

    7 Cleaning and Disinfection Instructions for Use 7.3 Cleaning the Front Lens CLARUS 500 2. If dust remains, start in the center of the lens surface and wipe in widening circles with the felt end of the LensPen, applying gentle pressure.

  • Page 111: Cleaning The Front Window Lens

    Instructions for Use 7 Cleaning and Disinfection CLARUS 500 7.3 Cleaning the Front Lens 5. To verify that cleaning has been successful, take a photograph in a darkened room. Check the resulting image for bright spots. Figure 23: Residual Bright Spots after Cleaning 7.3.4 Cleaning the Front Window Lens...

  • Page 112: Cleaning The Chinrest And Forehead Support

    7 Cleaning and Disinfection Instructions for Use 7.4 Cleaning the Chinrest and Forehead Support CLARUS 500 4. Soak the tissue with acetone. 5. Brush the fold in the tissue across the surface of the optic using light pressure. 6. Repeat as necessary until the optic is clean, making sure new lens tissue is exposed with each wipe.

  • Page 113: Maintenance

    Complete patient exam with instrument before starting service. 8.2 Maintenance Schedule Periodically inspect the CLARUS 500 to ensure that the instrument is free of dust and the optics are cleaned as instructed. Frequency of inspections depends on the frequency of use and the environ- mental conditions.

  • Page 114: Data Storage - Backup

    8. Select the network drive or USB flash drive to export the file to, then select Continue. 9. A confirmation is displayed and the file “ServicePackage.svp” is saved to the selected drive. Send the file to ZEISS service for further assistance. 8.4 Data Storage - Backup Action 1.

  • Page 115: Troubleshooting

    Read the user documentation. Follow directions carefully. Do not make upgrades, or carry out repairs or modifications, without specific guidance and instruction from ZEISS or an au- thorized ZEISS represenative. Using a non-approved or incorrectly connected device CAUTION! could invalidate the system safety approval.

  • Page 116: Error Messages

    System Malfunction Call for Service ror and must be rebooted before acquiring additional scans. All work has been saved. If this problem per- sists, please contact ZEISS customer support. Continue in review mode or Re- boot. Mapper not found error occurred...

  • Page 117: Information Messages

    Instructions for Use 9 Troubleshooting CLARUS 500 9.3 Information Messages Message / Fault Cause Solutions You have exceeded the maximum System Malfunction Call for Service thumbnails limit of {0} in selection bin. Please remove existing thumb- nails from selection bin to add new thumbnails.
  • Page 118 9 Troubleshooting Instructions for Use 9.3 Information Messages CLARUS 500 Message / Fault Cause Solutions Importing exams in progress... Indicates the progress of an imported exam. Log file saved successfully. Indicates that the log file Click OK. saved successfully Number of exams selected for ex- Indicates the number of exams port.

  • Page 119: Specifications

    Instructions for Use 10 Specifications CLARUS 500 10.1 Electrical Specifications 10 Specifications 10.1 Electrical Specifications Parameter Value External Power Supply 100 - 240 V~, 50 / 60 Hz, 4 A max Fuse T 4.0 A, L 250 V Electrical Class per IEC 60601-1 Class I 10.2 Instrument Specifications...

  • Page 120: Dimensions And Weight

    10 Specifications Instructions for Use 10.3 Dimensions and Weight CLARUS 500 10.3 Dimensions and Weight Parameters Value Dimensions (W x D x H) 362 mm by 546 mm by 676 mm Instrument Table Dimensions (W x 916 mm by 615 mm by 711 - 925...

  • Page 121: Laser Classification

    Instructions for Use 10 Specifications CLARUS 500 10.8 Laser Classification Parameter Value Resolution (zones defined in ISO 10940): • 60 lp/mm at central field (0°) • Center • 40 lp/mm at 23° FOV • Middle • 25 lp/mm at 95° FOV •...
  • Page 122 Empty page, for your notes...

  • Page 123: Legal Notices

    11.1 Software Copyright The software program (“Software”) included with your CLARUS™ 500 is a proprietary product of Zeiss and in certain instances con- tains material proprietary to Microsoft Corporation and other third party licensors, suppliers and vendors. These proprietary products are protected by copyright laws and international treaty.
  • Page 124 Empty page, for your notes...

  • Page 125: Accessories And User Replaceable Spare Parts

    Use only accessories authorized by ZEISS. 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. The procedure for returning defective parts from Interna- NOTE tional operations differs somewhat from that for U.S.

  • Page 126: Accessory Kit Parts List

    12 Accessories and User Replaceable Spare Parts Instructions for Use 12.2 Accessory Kit Parts List CLARUS 500 12.2 Accessory Kit Parts List Image Part Number Quantity Description Accessory Kit Box 2660021166736 Accessory Kit Box 2660021166733 DUST COVER CLARUS 2660100007672 LENS CLEANER...

  • Page 127: Replaceable Parts

    Instructions for Use 12 Accessories and User Replaceable Spare Parts CLARUS 500 12.3 Replaceable Parts 12.3 Replaceable Parts Part Number Description 2660021107501 Accessory bag 2660021167244 Fixation Device(External) 3197519005000 Occluding Sleeve for Fixation De- vice 3013509052000 Fixation Lamp (Red) 2660021161185 Keyboard 12.3.1 Covers...

  • Page 128: Equipment Return Authorization

    Authorization must be obtained from Carl Zeiss Meditec before equipment is returned for repair. A Return Material Authorization (RMA) number is required on each return shipment to Carl Zeiss Meditec. The procedure for obtaining an RMA number varies, depending on your area of operation.

  • Page 129: Decommissioning

    Attempting to decommission your system CAUTION! may result in damaged equipment and danger to personnel. Never attempt to decommission a ZEISS system or device. Only ZEISS approved field service representatives are qualified to safely decommission your system. Contact your ZEISS Representative to set up an appointment for system/device decommissioning.
  • Page 130 Empty page, for your notes...

  • Page 131: Packaging And Transport

    Packaging and transport by non-ZEISS personnel CAUTION! could result in damage, loss, or non-compliance within the country of transit. Allow only ZEISS-certified personnel to prepare the instrument and associated components for transport. Allow only ZEISS-approved personnel to transport the instru- ment and associated components.
  • Page 132 Empty page, for your notes...

  • Page 133: Disposal

    For more information about the disposal of the device, please contact the ZEISS contact partner in your country. If you want to sell on the device or its components: Inform the purchaser that they must dispose of the device according to the regulations valid at that time.
  • Page 134 Empty page, for your notes...

  • Page 135: Glossary

    Instructions for Use Glossary CLARUS 500 Glossary Electronic Medical Records. Any electronic medical records system, in- cluding FORUM, whether DICOM-compati- ble or not Fundus Autofluorescence. A type of fundus imaging in which the eye is illuminated with light at a wavelength that stimulates the natural fluorescence of lipofuscin.
  • Page 136 Empty page, for your notes...

  • Page 137: Index

    Instructions for Use Index CLARUS 500 Index Accessories .......... 125 Backing up Data Automatically .... 51 Acquire window ..........  28 Backing up Data Manually ...... 51 Acquisition .......... 28 Bright spots on images, removing.... 110 Acquisition settings........ 104 Bulk Export, Exam Data .......  45 Add a Printer ..........
  • Page 138 Index Instructions for Use CLARUS 500 Data Backups..........  51 Copy Caliper ............ 83 Annotation .......... 84 Caliper, Annotations ........ 86 Copyright Caution Software.......... 123 Definition.......... 10 Cautions Disregarding EMC Information .... 15 Change Laterality.........  44 Data Change Password ........ 49, 50 Automatic Backup........
  • Page 139 Instructions for Use Index CLARUS 500 Edit a Printer.......... 102 ID, Patient, Identifier........ 99 Electromagnetic Compatibility (EMC) ...  15 IEC 60825-1 .......... 7 Precautions .......... 15 Image brightness .........  31 Electromagnetic Immunity Image Brightness Adjustment ......  92 IEC 61000–4–11 ........ 17 Image capture ..........
  • Page 140 Index Instructions for Use CLARUS 500 LAN ............ 107 Language settings........ 99 Changing Laterality .........  44 Laser Online Help .......... 26 Classification.........  121 On-Screen Keyboard, Enable / Disable .. 99 Laser Safety and Compliance ...... 7 Operation Laterality Principles .......... 21 Chaning ..........
  • Page 141 Instructions for Use Index CLARUS 500 Properties, Printer, Setting ...... 102 Packing Parts for Shipment ...... 128 Parts Ordering, US .........  125 Reflectance imaging ...... 21, 63 Ording, International...... 125 Repair............ 113 Packing for shipment ...... 128 Safety ...........  113 Replaceable ..........
  • Page 142 Index Instructions for Use CLARUS 500 Safety Temperature requirements...... 120 Cleaning .......... 109 Test Page, Printers ........ 102 Decommissioning........ 129 Text Annotations .........  84 Definitions .......... 10 Theory of operation ........ 21 Maintenance.........  113 Time, System, Setting ........ 99 Repair ...........  113 Toolbar............
  • Page 143 Instructions for Use Index CLARUS 500 Zoom............ 31 Zoom In/Out Annotations ...... 83 2660021165005 Rev. A 2017-08 143 / 144...
  • Page 144 Carl Zeiss Meditec, Inc Carl Zeiss Meditec AG 2660021165005 Rev. A 2017-08 5160 Hacienda Drive Goeschwitzer Strasse 51-52 CLARUS™ 500 Dublin, CA 94568 07745 Jena User Manual Germany Specifications subject to change without notice Toll Free: 1-800-341-6968 Fax: + 49 (0) 7364 -20 4823 Phone: 1–925–557–4100...

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