Zeiss CLARUS 500, Instructions For Use Manual

Page 1: ...CLARUS 500 Instructions for Use ...

Page 2: ...dia Windows Server and Microsoft are ei ther registered trademarks or trademarks of Microsoft Corporation in the United States and or other countries Mac OS iMac iPad and QuickTime are either registered trade marks or trademarks of Apple Inc in the United States and or other countries All other trademarks used in this document are the property of their respective owners Patents http www zeiss com ...

Page 3: ...Electromagnetic Emissions 16 1 6 2 Electromagnetic Immunity 17 1 6 3 Wireless Communications 17 2 Introduction 19 2 1 Scope 19 2 1 1 Intended Use Indications for Use 19 2 2 Usage 19 2 3 Intended Audience 19 2 3 1 Patient Profile 19 2 3 2 Operator Profile 19 2 3 3 Data Analyst Profile 20 2 4 User Documentation 20 2 4 1 Purpose 20 2 4 2 Access 20 2 4 3 Conventions Used in This Document 20 2 5 Questi...

Page 4: ... 60 5 5 2 Blinking the Fixation Target 66 5 5 3 Manually Positioning the Internal Fixation Target 66 5 5 4 Capturing a Widefield Image 67 5 5 5 Capturing an Ultra Widefield Image 2 Image Montage 69 5 5 6 Capturing an AutoMontage Image 4 Image Montage 71 5 5 7 Capturing a Montage Image 2 6 Image Custom Montage 73 5 5 8 Capturing a Stereo Image 75 5 5 9 Capturing an External Eye Image 77 5 5 10 Usin...

Page 5: ... to a LAN 107 6 14 Data Storage 108 7 Cleaning and Disinfection 109 7 1 Safety During Cleaning 109 7 2 Cleaning Agents 109 7 3 Cleaning the Front Lens 109 7 3 1 Removing Fluid Splashes 109 7 3 2 Removing Minor Dust Accumulation 109 7 3 3 Removing Severe Contamination 110 7 3 4 Cleaning the Front Window Lens 111 7 4 Cleaning the Chinrest and Forehead Support 112 7 5 Peripherals and Table 112 7 6 Cl...

Page 6: ... Copyright 123 11 2 End User Software License Agreement 123 11 3 Acknowledgment 123 12 Accessories and User Replaceable Spare Parts 125 12 1 Parts Orders 125 12 1 1 U S Domestic Parts Ordering 125 12 1 2 International Service Operations 125 12 2 Accessory Kit Parts List 126 12 3 Replaceable Parts 127 12 3 1 Covers 127 12 3 2 Cables 127 12 4 Returning Defective Parts 127 12 4 1 Equipment Return Aut...

Page 7: ...r 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 Classification Group 1 Instrument Per ANSI Z80 36 and ISO 15004 2 Group 1 instruments are ophthalmic instruments for which no potential light hazard exists Class 1 Laser Product Per IEC 60825 1 1 1 3 RoHS Compliance The product is RoHS compliant acco...

Page 8: ...lectrical 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 Power On computer Power Off computer Protective Earth Fuse Direct Current Type B Applied Parts Manufacturer Authorized European Community Representative ...

Page 9: ... 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 Fragile Keep Dry This End Up Transport conditions humidity 10 to 95 Transport conditions temperature 40 C to 70 C Transport conditions atmospheric pressure 500 hPa to 1060 hPa ...

Page 10: ...minor or moderate injury u These are actions that can be taken to prevent the hazard 1 3 2 Warnings WARNING Opening the device covers may result in injury u Only ZEISS authorized service technicians may remove device covers WARNING Tipping the device may result in injury u Do not allow the patient to lean on the table or use it as a sup port to stand up WARNING Modifying this device may increase r...

Page 11: ...irements of IEC 60601 1 u You are responsible for ensuring that the system meets the safety requirements of IEC 60601 1 u Only approved equipment to their respective IEC ISO standards such as IEC 60601 1 or IEC 60950 are allowed to be connected to the Signal Input Output parts SIP SOPs u Place any AC powered non medical device peripherals at least 1 5 m away from the instrument and connect them to...

Page 12: ...lified personnel may use this device u This device may be used only for its intended purpose u Only ZEISS authorized personnel may perform maintenance or repair procedures not described in this manual 1 3 3 Cautions CAUTION Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous optical radiation exposure CAUTION Attempting to carry out...

Page 13: ...ecaution requirements and needs to be installed and put into service according to the EMC information provided herein CAUTION Use of the acquisition device a printer or the power table with an extension cord or a power strip multiple portable socket outlet could cause electrical shock to the patient or operator u Do not use extension cords with the instrument u Do not use power strips with the ins...

Page 14: ...ommunications equipment including peripher als such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the device including cables specified by the manufacturer u Otherwise degradation of the performance of this equipment could result CAUTION The CLARUS 500 is intended for use in a professional health care facility environment Using the instrument ...

Page 15: ...European Union only To the compentent authority in the state where the instrument operator is established 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 Since there is are no surgical or treatment decisions m...

Page 16: ...ally WARNING Portable RF communications equipment including peripher als such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the device including cables specified by the manufacturer u Otherwise degradation of the performance of this equipment could result NOTE The emissions characteristics of this equipment make it suitable for use in industri...

Page 17: ...EC 61000 4 4 2 kV 100 kHz repetition fre quency Surges line to line IEC 61000 4 5 0 5 kV 1 kV Surges line to ground IEC 61000 4 5 0 5 kV 1 kV 2 kV Conducted disturbances induced by RF fields IEC 61000 4 6 3 V 0 15 MHz 80 MHz 6 V in ISM bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 0 UT1 0 5 cycle ...

Page 18: ...17 Pulse 217 Hz 0 2 0 3 9 810 870 930 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse 18 Hz 2 0 3 28 1720 1845 1970 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse 217 Hz 2 0 3 28 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse 217 Hz 2 0 3 28 5240 5500 5785 5100 5800 WLAN 802 11 a n Pulse 217 Hz 0 2 0 3 9 Table 1 Test specifications f...

Page 19: ...age fields of view 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 2 3 1 Patient Profile This device may be used on any patient who is able to sit upright with his or her face in the instrument s chin and forehead rest in dependently or with assistance 2 3 2 Operator Pr...

Page 20: ...to know how to evaluate fundus im ages 2 4 User Documentation 2 4 1 Purpose The user documentation that comes with your device is provided to ensure that all users operate and maintain it safely and successfully Read all user documentation before starting and using the de vice Keep all user documentation where it is accessible at all times for all users Pass the user documentation on to the next o...

Page 21: ...xcitation FAF G and FAF B Stereo imaging External eye imaging 2 6 1 1 Principles of Operation Using a monochromatic camera a broad line of illumination scans across and detects the retina Red green and blue LEDs light emitting diodes sequentially illumi nate to generate true color images The broad bandwidth of LEDs gives a true color rendering Blue and green LED illumination for FAF fundus auto fl...

Page 22: ... center of the eye FOV of 90 when measured as described in ISO 10940 Ultra widefield Two images stitched together into a mon tage with a 200 FOV when measured from the center of the eye 135 when measured as described in ISO 10940 AutoMontage a 4 scan montage using preset fixation tar gets Montaged images 2 6 widefield images stitched into a single combined retina image 2 6 2 Hardware Overview The ...

Page 23: ...uction CLARUS 500 2 6 System Overview 2660021165005 Rev A 2017 08 23 144 2 6 2 1 System Hardware 1 2 3 4 5 6 Figure 1 System Hardware 1 CLARUS 500 Acquisition De vice 2 All in One PC 3 Pivoting Rack 4 Touchpad 5 Keyboard 6 Joystick ...

Page 24: ... 2017 08 2 6 2 2 Patient View 1 2 3 4 Figure 2 Patient View 1 Forehead rest Helps keep the patient s head steady and in place 2 Front lens Aperture for image acquisition 3 Chin rest Positions the patient s head at the correct height 4 Chin rest ad juster Manually raises and lowers the chin rest ...

Page 25: ...ure 3 Operator Controls 1 Focus knob Manually adjusts the focus 2 Friction knob Tightens or loosens the swivel movement of the acquisition head 3 Cross table lock Locks the cross table so that the acquisition head cannot move 4 Joystick Moves the acquisition head side to side and for ward and back The joystick button triggers image capture ...

Page 26: ... directs the patient s gaze when A patient has difficulty fixating on internal fixation target 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 2 6 3 1 Main Toolbar Figure 5 Main Toolbar Pos...

Page 27: ...e application on the computer s desktop 7 Allows you to select whether to log off or shut down 2 6 3 2 Patient Window Use the Patient window to find edit and add patient records 1 2 3 4 5 6 7 8 9 Figure 6 Patient Window Pos Name Explanation 1 Search field Searches for a patient record by patient name ID or date of birth 2 Advanced Opens the Advanced search which allows a more detailed search 3 Add...

Page 28: ... pre pare reports 7 History Lists the selected patient s scans from prior visits 8 All Lists patient records available on the local database 9 Today Lists patient records for the patients scheduled today 2 6 3 3 Acquire Window Use the Acquire window to set image capture options and capture images 1 2 3 4 5 6 7 8 9 10 11 13 12 Figure 7 Acquire Window Pos Name Explanation 1 Patient data Information ...

Page 29: ...hat have already been captured along with the capture settings 7 Analyze Opens the Analyze window 8 Focus Displays the current focus and allows for manual focus adjustments 9 Blink internal fixation tar get Blinks the internal fixation target for a configurable amount of time 10 Capture Captures the image 11 Pupil Size Toggles between mydriatic and non mydriatic acquisition mode 12 Fixation Type T...

Page 30: ...o filter the images to show only those taken between the start date and end date you set 5 Scan type filter Allows you to select which type s of scans to show 6 View Allows you to select what size to display the images in preview 7 Sort Allows you to group the images by scan type or laterality or show im ages in the order they were taken Date Time 8 Clear Remove all thumbnails from the Selection b...

Page 31: ...4 Adjust image Opens the brightness contrast saturation and sharpness sliders 5 Adjust Color Opens the color adjustment tool 6 Rotate Rotates the image 180 clockwise 7 Save Saves the edited image 8 Print Report Opens a preview of the report to print 9 Montage Allows you to select scans and create a montage image from them 10 Stereo Provides a stereo view of the image 11 Sort Selection Allows you t...

Page 32: ...requirements of IEC60601 1 u Place any AC powered non medical device peripherals at least 1 5 m away from the device and connect them to a separation device or else use an isolation transformer WARNING Connection to It Networks including other equipment could result in previously unidentified risks related to patients oper ators or third parties Changes to the IT networks could introduce new risks...

Page 33: ...onnector on the other end This cable is included in the accessory kit shipped with the instrument 3 1 Hardware Installation 3 1 1 Installation Requirements Install the CLARUS 500 instrument in an environment that meets the following requirements no direct sunlight properly grounded dedicated 15 A power source that meets all local electrical codes not connected to a power strip the device s ventila...

Page 34: ...mark benchmark score of at least 5675 Has at least 8 GB of memory Has at least 100 GB of disk space available Has a monitor with resolution set to at least 1920 x 1080 Review software does not support the following functions Adding Editing or Deleting the equipment data Deleting a Scan Adding users or user accounts Prerequisite þ The computer and monitor meet the minimum requirements listed above ...

Page 35: ...llation 2660021165005 Rev A 2017 08 35 144 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 and browse to the desired folder ...

Page 36: ...structions for Use CLARUS 500 3 2 Software Installation 36 144 2660021165005 Rev A 2017 08 8 Click Next 9 If this review software will use Remote Destop Services check Remote Desktop services will be used 10 Click Next ...

Page 37: ...r system prompts you to confirm changes on the com puter click Yes ð Review software installation begins Installation takes sev eral mintues to complete 13 When installation is complete click Finish 3 2 2 Upgrading Instrument and Review Software Action 1 Select the Maintenance tab on the Settings screen Under Update click Start Update ...

Page 38: ...n 38 144 2660021165005 Rev A 2017 08 2 Confirm that you would like to continue Result ü The software installs and the system reboots When you upgrade instrument or review software CLARUS 500 re tains stored information including Logins and Passwords Patient Data Exam Data ...

Page 39: ...rly If the di agnosic check detects any problems an error or alert message dis plays For more information about startup errors and alerts refer to Troubleshooting 115 NOTE If a critical system test fails take the device out of service u Contact your ZEISS representative u If a non critical test fails or a warning appears the device can still be used Contact your ZEISS representative See Mainte nan...

Page 40: ...passes the system check upon startup and when a user logs off the login screen opens NOTE An Administrator must add a user s name and password be fore that user can log in Adding a New User 48 NOTE Passwords are case sensitive Action 1 Double click on the Ziess application icon ð The login screen opens 2 Select your user name 3 Type your password ...

Page 41: ...ribed in the chapter Maintenance 113 5 2 Managing Data 5 2 1 Manage Patient Records When patient records are imported from an EMR they are recon ciled with local records as follows Same ID and Issuer of ID different name date of birth or gen der The local record is updated to match the EMR record Different ID or Issuer of ID A new patient record is generated Some EMR systems allow records that are...

Page 42: ...ds If two records are inadvertently created for the same patient they can be merged to store all the patient data in one record Action 1 In the Patient window select the patient name and click on the down arrow 2 Select Merge 3 Type the name or ID for the duplicate patient record in the search field and click Search 4 Select the duplicate patient record s You can merge up to 20 patient records 5 T...

Page 43: ...Patient window search for the patient record that was incorrectly associated with the data See Search for a Patient Record 2 Select the patient record then open the drop down menu by clicking on the down arrow Select Exam 3 Select the data to reassign then select Reassign 4 In the search field type a few letters of the name ID number or DOB of the patient record the data should be assigned to then...

Page 44: ... Laterality change feature does not work under the following condi tions After the data is exported In connected mode FORUM On imported data Prerequisite þ Acquire Review or Proof Sheet is open Action 1 Select the image you want to change 2 Click the existing laterality indicator OD or OS 3 Click the desired laterality OD or OS ð The laterality indicator changes for the image 4 Click Save 5 2 1 6 ...

Page 45: ...ntegrity of Imported Records 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 a patient that was already imported the device does the following imports all scan data exams not previously imported but never deletes nor overwrites any scan data already ...

Page 46: ...mages and right click Export all of a patient s data select Settings Specific Set tings Export Set automatic export Configuring Import and Export 104 Action 1 If you are exporting to removable media insert the media into the USB port 2 Click Settings Specific Settings ð The Specific Settings window opens 3 Click Export ð A list of all patients opens 4 Check the patients you want to export and clic...

Page 47: ...is instrument or review software NOTE Unsecured Logins may result in unauthorized access or inaccurate record keeping u Create individual user accounts for each staff member u Staff members should log out after every use 5 2 2 1 About User Access Not all users have access to all features The table below list some of the key differences for different types of users Operator Doctor Administrator Acq...

Page 48: ...ss words X Add or delete Operators or Doctors X Export log files X Add or delete Administrators X Table 2 Permissions Levels 5 2 2 2 Adding a New User NOTE Only Administrators can complete this task Action 1 Click Settings User Management 2 Click Add User 3 Type the information for the new user and select the user s role 4 Click Add User Result ü The new user can now log in ...

Page 49: ... Management 2 Select the Login name for the user you want to delete 3 Click Delete User Result ü The user s Login is now disabled 5 2 2 4 Changing a User s Password NOTE Only Administrators can complete this task Prerequisite þ Settings are open Action 1 Select User Management 2 Select the Login name for the user who needs a new pass word and click Change Password ð The password reset panel opens ...

Page 50: ...wn Password Action 1 Click Settings User Management 2 Click Change Password 3 For Old password type your existing password 4 For New password type a new password 5 For Repeat new password retype the new password Result ü Your password is now changed to the new password 5 2 3 Manage Backups On the CLARUS 500 you can enable data backup each time the system shuts down Configuring Automatic Backups 51...

Page 51: ...tions Action 1 Insert the removable media into the USB port 2 Click Settings Maintenance ð The Maintenance window opens 3 Slide Data backup on Shutdown to Backup Enabled 4 Click Browse 5 Navigate to the folder where you want to store the backups and click Select Result ü Each time the system shuts down a backup will be saved in the selected folder 5 2 3 2 Backing Up Data Manually Action 1 Insert t...

Page 52: ...ee Configuring Automatic Back ups 51 5 2 3 3 Restoring Data from a Backup NOTE Only Administrators can complete this task 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 Action 1 5 2 4 Log Files CLARUS 500 records the following events and identifies them by date time and User ID Log on log off Create...

Page 53: ...ice Action 1 Wipe the chinrest and forehead rest with an alcohol pad and allow the assembly to dry See Cleaning the Chinrest and Fore head Support 112 2 Carefully read and understand any instructions provided by the officiating physician or researcher 5 4 Preparing the Patient NOTE Keep the front of the lens clean The quality of image capture is greatly affected by the cleanliness of the front len...

Page 54: ...he patient is not in the database add the patient s infor mation See Adding a Patient 41 Action 1 Find the patient s name using the list or search and select the patient s name 2 Click Acquire 5 4 2 1 Finding a Patient Action 1 To find a patient using Search type the first name last name patient ID or a scan date of the person you want to find 2 Click the Search icon 3 To refine your search criter...

Page 55: ... 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 Rest their forehead against the forehead rest 3 Adjust the chin rest up or down as needed until align the pa tient s canthus to the canthus marker on the patient support ...

Page 56: ...n Instructions for Use CLARUS 500 5 4 Preparing the Patient 56 144 2660021165005 Rev A 2017 08 4 Swing the acquisition head left to align with the patient s right eye or right to align with the patient s left eye ...

Page 57: ...ansparent band you can change the pupil setting to Non Myd or dilate the patient s pupils Action u Push the acquisition head closer to the patient u Twist the joystick to move the acquisition head up or down un til the patient s pupil is aligned with the transparent band u If the patient s pupil is smaller than the transparent band change the setting to Non Myd or dilate the patient s pupil Dilati...

Page 58: ...live view of the fundus appears in the live IR preview window u Ensure that the image is in focus If needed manually focus the image Manually Focusing the Image 59 u Make fine adjustments as needed to eliminiate any shadows showing in the IR preview window u If either alignment is not centered repeat these steps until they are centered ...

Page 59: ...site þ You reached the focus step in a Scan Acquisition task þ You want to manually focus the image Action u Uncheck Autofocus u 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 1 2 3 4 u Use the focusing guides 4 in the upper left corner of the IR Preview panel to aid in focus ...

Page 60: ...or Use CLARUS 500 5 5 Acquire Images 60 144 2660021165005 Rev A 2017 08 5 5 Acquire Images 5 5 1 Acquisition Options 5 5 1 1 Field of View Options 3 4 1 2 Pos Description Example 1 Widefield WF Single image 133 wide by 133 high ...

Page 61: ...se 5 Operation CLARUS 500 5 5 Acquire Images 2660021165005 Rev A 2017 08 61 144 Pos Description Example 2 Ultra Widefield UWF Two image montage 200 wide by 133 high 3 Auto Montage Four image montage 200 wide by 200 high ...

Page 62: ...5 Operation Instructions for Use CLARUS 500 5 5 Acquire Images 62 144 2660021165005 Rev A 2017 08 Pos Description Example 4 Montage Up to six images montaged in an opera tor selected configuration ...

Page 63: ... Example images shown below are taken from scans acquired from multiple subjects 1 2 3 4 Pos Description Explanation Example 1 Color Color High resolution color images of the fundus appear similar in color to direct observation ophthalmoscopy You can also view a monochrome image of each composite color red green and blue ...

Page 64: ...5 Operation Instructions for Use CLARUS 500 5 5 Acquire Images 64 144 2660021165005 Rev A 2017 08 Pos Description Explanation Example Blue Channel Red Channel Green Channel ...

Page 65: ... FAF Green Fundus autofluores cence with green exci tation The eye is illu minated with light at a wavelength that stimu lates the natural fluo rescence of lipofuscin A monochrome image is generated 4 FAF Blue Fundus autofluores cence with blue excita tion The eye is illumi nated with light at a wavelength that stimu lates the natural fluo rescence of lipofuscin A monochrome image is generated 5 5...

Page 66: ... the 90 degree circular FOV 5 5 2 Blinking the Fixation Target If the patient is having trouble seeing the internal fixation target you can blink the target to make it easier for them to see To can change the blink settings refer to Configure Capture Settings 104 Prerequisite þ A patient is being prepared for Scan Acquisition and cannot see the fixation target 1 Action 1 Click the blink buttion 1 ...

Page 67: ...the Preview panel and the patient s FOV 5 5 4 Capturing a Widefield Image Figure 11 Widefield Fixation Tar get 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 Blink the fixation target Blinking the Fixation Target 66 Change the fixation target Manually...

Page 68: ...Myd if the patient s pupil is dilated and Non Myd if the patient s pupil is not dilated u Instruct the patient to look inside the imaging aperture focus on the green fixation target and blink naturally u The instrument automatically focuses the image To manually adjust focus refer to Manually Focusing the Image 59 u Instruct the patient to blink and then open their eyes wide u Click the joystick b...

Page 69: ...Use the external fixation target Using the External Fixation Tar get 77 Prerequisite þ The device is prepared See Preparing the Device 53 þ The patient is prepared See Preparing the Patient 53 Action u Under Scans select UWF u Select the Scan Type Color IR FAF Green or FAF Blue For more information about Scan Types refer to Scan Types 63 u For Pupil Size select Myd if the patient s pupil is dilate...

Page 70: ...delete and retake the image See Deleting or Replacing an Im age 78 ð The internal fixation target advances to the next position in the sequece u Recheck adjustments and focus for the second scan in the se ries and click Capture ð A preview of the captured image appears for several sec onds and is added to the capture bin ð If the image can be included in a montage it will have a green checkmark u ...

Page 71: ...complete all four scans CLARUS 500 saves the com pleted scans as individual wide field scans Prerequisite þ The device is prepared See Preparing the Device 53 þ The patient is prepared See Preparing the Patient 53 Action u Under Scans select AutoMontage u Select the Scan Type Color IR FAF Green or FAF Blue For more information about Scan Types refer to Scan Types 63 u For Pupil Size select Myd if ...

Page 72: ...review the scan ð The internal fixation target advances to the next position in the sequece u Next Scan confirm alignment and focus for the next scan in the series and click Capture ð A preview of the captured image appears for several sec onds and is added to the capture bin ð If the image in the selection bin has a yellow exclamation point delete and retake the image See Deleting or Replac ing a...

Page 73: ... 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 age you can choose any internal fixation target location or have the patient focus on the external fixation target Using the External Fixation Target 77 Prerequisite þ The device is prepared See Preparing the Device 53 þ The patient is prepared See P...

Page 74: ... focuses the image To manually adjust focus refer to Manually Focusing the Image 59 u Instruct the patient to blink and then open their eyes wide u 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 ð If the image can be included in a montage it will have a green checkmark u If the image in the selection bin h...

Page 75: ...Prerequisite þ The device is prepared See Preparing the Device 53 þ The patient is prepared See Preparing the Patient 53 Action u Under Scans check Stereo u Select the Scan Type Color IR FAF Green or FAF Blue For more information about Scan Types refer to Scan Types 63 u Under Settings select Myd if the patient s pupil is dilated and Non Myd if the patient s pupil is not dilated u Adjust the align...

Page 76: ...cluded in a montage it will have a green checkmark u If the image in the selection bin has a yellow exclamation point delete and retake the image See Deleting or Replacing an Im age 78 u Adjust the alignment for the second stereo image 2 offset to the other side of the pupil 1 2 ð A preview of the captured image appears for several sec onds and is added to the selection bin ð If the image can be i...

Page 77: ... the way back u Slowly move the instrument forward until the patient s eye ap pears in the Preview screen as you want it to appear in the im age u Use the joystick to manually focus the image u Instruct the patient to look straight ahead The fixation target may not be visible and it is not necessary for the patient to fo cus on the fixation target for this scan u Instruct the patient to blink u Cl...

Page 78: ...be reviewed for ac ceptance prior to being released for analysis Reivew all scans carefully If possible retake scans that do not pass the acceptance criteria Deleting or Replacing an Image 78 Action 1 Check that the focus is sharp and clear 2 Ensure that the image is illuminated uniformly 3 Ensure that there are few to no artifacts that cast shadows on the image 5 5 12 Deleting or Replacing an Ima...

Page 79: ...ge you want to recapture 1 2 Click on the X 1 to delete the image ð A confirmation opens 3 To delete and recapture the image click Delete Recapture 4 To delete the image click Delete 5 6 Analyze Images There are two Analyze modes Proof and Review Proof allows you to sort and select images Review allows you to view compare and annotate images ...

Page 80: ...mages by scan type date of acquisition laterality and favorite status Figure 18 Analyze Proof Screen 5 6 2 Review Review shows the images selected in Proof Review allows you annotate and edite scans save them and print a report Figure 19 Analyze Review Screen 5 6 3 Opening the Analyze Window You can analyze that patient s images by clicking Analyze Action 1 Select the patient Selecting the Patient...

Page 81: ...es to include in the Review you can sort and filter in the following ways Laterality Scan type Date and time acquired Prerequisite þ The selected patient has saved scans þ The Review screen is open 1 2 3 4 5 6 7 8 9 10 11 12 Action 1 In the View panel 11 click on the image s you want to in clude in review Use the sorting and filtering options to help lo cate the images ð Thumbnails of the selected...

Page 82: ... laterality choose Sort Laterality 7 9 To sort selected scans by scan type choose Sort Scan Type 7 10 Once all scans for review are in the selection bin 10 click Re view 9 5 6 5 Editing Scanned Images To edit images select one or more images in the viewport and use the editing toolbar To apply the same edits to multiple images select multiple images before you begin to edit 5 6 5 1 Choosing How Ma...

Page 83: ...ð The zoom adjustment panel opens 3 Zoom and pan the image until you see the area of the image you want to save 4 Close the zoom adjustment panel 5 6 5 3 Annotating Images Most annotations must be inside the image or field of view to save them on an image The caliper tool for indicating measurement can stretch beyond the image borders Figure 20 Symbol Name Explanation Text Adds text annotations to...

Page 84: ...arrows on the image to identify something specific on the image You can add text to ar rows to label what you are identifying on the image After you place arrows on the image you can resize move or delete them Prerequisite þ The Analyze window is open Opening the Analyze Window 80 Action 1 Select the Annotations tool ð The annotations tools panel opens 5 6 5 3 2 Adding Text to Images You can add t...

Page 85: ...s You can draw any length arrow or mulitple arrows on the image to identify something specific on the image You can add text to ar rows to label what you are identifying on the image After you place arrows on the image you can resize move or delete them Prerequisite þ The Analyze window is open Opening the Analyze Window 80 þ The Annotation tool is selected Selecting the Annotation Tool 84 Action ...

Page 86: ...ge 5 6 5 3 4 Adding Measurements to Images When you draw caliper lines on an image the review software cal culates the measurement After you draw caliper lines you can edit move or delete them Prerequisite þ The Analyze window is open Opening the Analyze Window 80 þ The Annotation tool is selected Selecting the Annotation Tool 84 Action 1 Select the Caliper tool 2 Touch or right click at the appro...

Page 87: ...line the review soft ware calculates its length 5 6 5 3 5 Circling an Area of an Image Prerequisite þ The Analyze window is open Opening the Analyze Window 80 þ The Annotation tool is selected Selecting the Annotation Tool 84 Action 1 Select the Circle tool 2 Touch or right click at the appropriate starting point and drag around the area of the image you want to emphasize ...

Page 88: ...age The Freehand tool allows you to draw any shapes around findings you want to emphasize After you place shapes on the image you can move or delete them Prerequisite þ The Analyze window is open Opening the Analyze Window 80 þ The Annotation tool is selected Selecting the Annotation Tool 84 Action 1 Select the Freehand tool 2 Touch or right click at the appropriate starting point on the im age an...

Page 89: ...h other in order to copy to the appropriate location This process will only work well for good quality images where the images are of the same eye over the same portion of the eye If the registration between images is poor the annotations may be copied to the wrong part of the image u You can select the annotation and move it to the correct loca tion Prerequisite þ The Analyze window is open Openi...

Page 90: ...cted images The thumbnails in the panel are in the same configuration as the larger images in Pre view 2 Inside the copy paste panel click on the source icon and drag it to the thumbnail that represents the image with annota tions to copy 3 Inside the copy paste panel click on the desintaion icon and drag it to the thumbnail that represents the image to paste an notations onto ...

Page 91: ...an Image Hide All temporarily hides all annotations on the image allowing you to see the original image only Prerequisite þ The Analyze window is open Opening the Analyze Window 80 þ The Annotation tool is selected Selecting the Annotation Tool 84 Action 1 Select the image you want to view without annotations ð The selected image is outlined in blue 2 Check Hide All ð Annotations are temporarily h...

Page 92: ... them together Prerequisite þ The Analyze window is open Opening the Analyze Window 80 þ The Annotation tool is selected Selecting the Annotation Tool 84 Action 1 Select 5 6 5 4 Adjusting Image Brightness Prerequisite þ The Analyze window is open Opening the Analyze Window 80 þ Image s are selected Selecting and Sorting Images 81 Action 1 Select the image you want to adjust ð The selected image is...

Page 93: ...l 5 6 5 5 Adjusting Image Color Tones Prerequisite þ The Analyze window is open Opening the Analyze Window 80 Action 1 Select the image you want to adjust ð The selected image is outlined in blue 2 Click the color adjustment icon ð The color adjustment panel opens 3 Adjust the settings until the image color is the way you want to save it 4 Close the color adjustment panel 5 6 5 6 Rotating Images A...

Page 94: ...he same eye are selected Selecting and Sorting Images 81 Action 1 Click Montage ð The montage bin opens 2 Drag each thumbnail image want to include in the montage into a slot in the Montage bin 3 Click Create ð A progress bar appears as the montage image forms 4 When the montage image completes click Save 5 6 7 Viewing Stereo Images Stereo image pairs can be viewed in stereo mode When you view ima...

Page 95: ...ge The thumbnail identifies images that were edited If you did not make any changes to an image you select to save no changes or copies of the image are made Prerequisite þ Analyze Review window is open þ Editing and annotations were made as required on image s Action 1 Click the Save icon ð Images that you edited or annotated are automatically se lected and identified to Save 2 To deselect an ima...

Page 96: ...ck Add Comment 6 Select Print Save or Save Print 4 5 7 Shutdown The windows password must be updated every 60 days Shut down and restart the instrument regularly On startup the in strument prompts you when it is time to update the windows pass word 5 7 1 Logging Off Action 1 Select the X in the upper right corner 2 Select Log off 5 7 2 Shutting Down Each time you shut down the system all shutdown ...

Page 97: ...eration CLARUS 500 5 7 Shutdown 2660021165005 Rev A 2017 08 97 144 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 ...

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Page 99: ...ction 1 Select General Settings 2 For Institution Information complete the form for your clinic 3 For Alert display time select the number of seconds you want system or instrument alerts to display 4 For Locale Settings select the language and date formats 5 Scroll to set additional general settings 6 For System Date and Time select the appropriate settings 7 To display the onscreen keyboard slide...

Page 100: ...RUS 500 has an options wizard for initial settings that you can also use for checking or resetting options NOTE Only Administrators can complete this task Action 1 Click on the Settings icon 2 Select Maintenance and click Run Wizard ð The initial settings wizard opens and steps you through set tings 6 3 Configuring Report Settings You can add your logo and a signature field to reports You can also...

Page 101: ...t logo and navigate to the logo file and select it 5 To set a path to store reports click Browse next to Report storage path 6 4 Configuring Printers You can add your logo and a signature field to reports You can also set the path for storing reports and manage printers Prerequisite þ Settings are open Action 1 Select General Settings 2 Scoll to the bottom of the General Settings panel 3 Click Man...

Page 102: ...and click Delete 7 To set a default printer select the printer and click Set as De fault 8 To change the properties for a printer select the printer and click Properties 9 To print a test page select the printer and click Print test page 10 Click Close 6 5 Configuring Acquisition Settings You can add your logo and a signature field to reports You can also set the path for storing reports and manag...

Page 103: ... user login is required This setting must be deactivated in order to make changes to network maintenance or user management settings Automatic logoff time Sets the amount of system idle time before the user is automatically logged off Password strength Sets the requirements for passwords Simple no requirements Complex password must have at least six characters and be either a mix of upper and lowe...

Page 104: ...Show last captured image for x seconds Sets how long in seconds an image is dis played after capture Blink Fixation target for x seconds Sets how long in seconds the fixation target blinks when the operator selects the Blink but ton on the Acquire screen Autofocus Turns autofocus on by default Reset to Factory De fault Returns all acquisition settings to the default settings 6 8 Configuring Import...

Page 105: ...Auto import file If this setting is on files in the configured folder are automatically imported Select auto import folder path Sets the location where the CLARUS 500 soft ware will automatically look for files to import 6 9 Configure a Stand Alone Instrument Action u On the Networking tab of the Settings window under DICOM Configuration set DICOM network to Disabled 6 10 Clearing Alert History Pr...

Page 106: ...ts whether CLARUS 500 automatically issues patient IDs for new patients Show patient names in different ways Sets whether names can include a combination of character types for example Latin alphabet and ideographic 6 12 Connecting to a Wireless Printer NOTE Connect only to wireless printers recommended NOTE Only Administratorsand Doctors can complete this task Prerequisite þ The CLARUS 500 and pr...

Page 107: ...sing a network cable Be gentle with the connector when plugging it into the CLARUS 500 ethernet port þ Settings are open Action 1 Select Networking 2 To automatically assign an IP address to the instrument set DHCP to Enabled For a network with static IP addresses set DHCP to Disabled and enter the relevant network informa tion 3 Under Network Drive Configuration select Map 4 Enter the network pat...

Page 108: ...r enter the username and password Otherwise leave these fields blank 7 Select Map ð Successfully mapped drives are indicated with a check mark in a green circle 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: ...cotton ball sticks front lens Microfiber cloth front lens 7 3 Cleaning the Front Lens NOTE Using harsh cleaning agents may damage the device u Use only the recommended cleaning materials 7 3 1 Removing Fluid Splashes The most common cause of minor fluid contamination is from the patient s tears splashing onto the lens when the patient blinks These drops show up in images as light spots Action 1 St...

Page 110: ...rom patients sneezing or touching the lens with their nose or fingers This causes distinct bright areas on the image Figure 22 Fundus Image with Fingerprint Contamination Action 1 Using moist disposable cloths or microfiber cloths cotton ball sticks or Safebuds sprayed with cleaning fluid start in the cen ter of the lens surface and wipe in widening circles Do not al low your fingers to touch the ...

Page 111: ...orming Action 1 Blow off dust 2 Using a soap saturated lens tissue placed around a swab wipe the optic gently in a figure eight motion 3 Repeat as necessary 4 Repeat this procedure with distilled water 5 Repeat again with alcohol 6 Repeat once more with acetone 7 3 4 2 Brush Cleaning Method This technique is ideal for cleaning smaller optics including lenses and involves holding a folded lens tiss...

Page 112: ...new lens tissue is exposed with each wipe 7 3 4 4 Dust Cleaning Dust on optics can be very tightly bound by static electricity Blow ing removes some dirt the remainder can be collected by the sur face tension of a wet alcohol swab Acetone helps promote rapid drying of the optic to eliminate streaks Action 1 Blow off dust 2 If any dust remains twist lens tissue around a swab soak in al cohol and wi...

Page 113: ...e 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 Component Task Interval External fixation lamp diode Replace As needed Illumination source Check brightness As needed 8 3 Offline Teleservice If an internet connection is not available you can use offline Tele service to create a ...

Page 114: ...stance 8 4 Data Storage Backup Action 1 All data stored on the hard disk and any external media are the Purchaser s records and it is his or her responsibility to pre serve the integrity of these files Carl Zeiss Meditec is not re sponsible for the loss of patient files stored on the hard disk or external media The Purchaser assumes the responsibility for the installation use and results obtained ...

Page 115: ...ed by ZEISS CAUTION Attempting to carry out activities not specifically endorsed by ZEISS may void your warranty and could result in damage to the instru ment u Read the user documentation u Follow directions carefully u Do not make upgrades or carry out repairs or modifications without specific guidance and instruction from ZEISS or an au thorized ZEISS represenative CAUTION Using a non approved ...

Page 116: ... encountered an er 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 System Malfunction Call for Service Mapper not found error occurred while importing exam data System Malfunction Call for Service Montage could not be created with selected images System Malfunction ...

Page 117: ...ave or discard ed its Suggests optional action N A De identify patient data Confirms to hide patient infor mation such as name date of birth ID Click OK Delete context menu item in proof sheet Confirms that you want to re move an item from the proof sheet Click OK Delete selected annotations Confirms that you want to delete the annotations Click Yes to delete the selected annotations Click No to r...

Page 118: ... Session Daily or other choice Source and destination images are both required in order to copy an notations When copying annotations informs you when either or both a source and destination for the annotations is missing Click OK and select a source image and a destination image for copying annotations Tests will be merged with current database Confirms that you want to save the scans in the data...

Page 119: ...e Imaging Modes Reflectance images true color IR Live IR preview image Fundus autofluorescence with blue or green excitation FAF B FAF G Stereo images External eye images Mode of Operation Continuous Working Distance 25 mm cornea to glass Device Group ANSI Z80 36 ISO 15004 2 Group 1 Service Life 7 years 10 2 1 At Instrument Computer Specifications Parameter Value Data Ports 2 network 4 USB3 2 USB2...

Page 120: ...rameter Value Temperature 10 C to 35 C Relative Humidity 30 to 90 non condensing Atmospheric Pressure 800 hPa to 1060 hPa 10 5 Ambient Requirements for Storage Parameter Value Temperature 10 C to 55 C Relative Humidity 10 to 95 non condensing Atmospheric Pressure 700 hPa to 1060 hPa 10 6 Ambient Requirements for Transport Parameter Value Temperature 40 C to 70 C Relative Humidity 10 to 95 non cond...

Page 121: ... A 2017 08 121 144 Parameter Value Resolution zones defined in ISO 10940 Center Middle Periphery 60 lp mm at central field 0 40 lp mm at 23 FOV 25 lp mm at 95 FOV Sensor Color Imaging Fluorescence Imaging 3 x 12 megapixels 12 megapixels monochrome 10 8 Laser Classification Class 1 laser product ...

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Page 123: ...oftware License Agreement Upon initial configuration of your CLARUS 500 you will be pre sented with an End User Software License Agreement the EULA which you must accept in order to use the Software The EULA is a legal contract between You and Carl Zeiss Meditec Inc which governs Your use of the Software If you do not agree with the terms and conditions of the EULA and do not agree to be bound by ...

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Page 125: ...differences are noted in the instructions u Please follow the instructions carefully NOTE Part numbers are subject to change u When ordering confirm all part numbers with your ZEISS Rep resentative 12 1 Parts Orders 12 1 1 U S Domestic Parts Ordering Spare parts may be ordered as needed following established parts ordering procedures Parts needed overnight may be ordered by phone from the Parts De...

Page 126: ... List Image Part Number Quantity Description Accessory Kit Box 2660021166736 1 Accessory Kit Box 2660021166733 1 DUST COVER CLARUS 2660100007672 1 LENS CLEANER 2660100007673 1 LENS WIPES 2660021121819 1 CABLE NETWORK CAT5E SNAGLESS BOOT 2660021165915 2 SCR M6X1 X16 THUMB 2660021167011 1 BRACKET ACCESSORY BAG 2660100022511 1 POWER CORD 120V 2660021147390 1 WIRELESS MOUSE ...

Page 127: ...e External 3197519005000 Occluding Sleeve for Fixation De vice 3013509052000 Fixation Lamp Red 2660021161185 Keyboard 12 3 1 Covers Designation Specification Part Number Dust Cover Instrument 2660021166733 Ocular Lens Cover 2660021165748 12 3 2 Cables Designation Length Part Number Ethernet CAT5E Shielded 1 5 m 59 in 2660021158754 Display Port Cable 2 m 79 in 2660021140192 12 4 Returning Defective...

Page 128: ...cedure for obtaining an RMA number varies depending on your area of operation Use the procedure that has been estab lished by Carl Zeiss Meditec for your area of operations 12 4 2 Packing for Shipment Defective instrument subassemblies parts should be packed in the shipping container received with the replacement subassembly or part If necessary contact the Carl Zeiss Meditec Parts Department for ...

Page 129: ...mmissioning 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 field service representatives are qualified to safely decommission your system u Contact your ZEISS Representative to set up an appointment for system device decommissioning ...

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Page 131: ... 1 Safety During 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 ZEISS certified personnel to prepare the instrument and associated components for transport u Allow only ZEISS approved personnel to transport the instru ment and associated components ...

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Page 133: ...by sending it for recycling through an ac knowledged collection system The device contains electronic components with integrated batter ies u Dispose of the device and integrated batteries correctly in ac cordance with national legislation The device specified on the delivery note must not be disposed off via household waste or communal disposal companies according to the applicable EU guidelines ...

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Page 135: ...ates the natural fluorescence of lipofuscin FAF Blue Fundus autofluorescence with blue excita tion FOV Field of View The measure that indicates how much of the eye can be imaged in a capture Field of view can be measured from the pupil as described in ISO 10940 or it can be measured from the center of the eye IOD Information Object Definitions Proofsheet A screen that presents thumbnails of all im...

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Page 137: ... Image Color 93 Arrows 85 Caliper Measurement 86 Circle 87 Deleting 92 Exporting 45 Freehand Shape 88 Hiding 91 Image Brightness 92 Importing 44 Text 84 Tool Panel 84 Zoom In Out 83 ANSI Z80 36 7 Application Upgrade 37 Arrow Annotations 85 Arrow Annotate Image 83 Assign Patient IDs 100 Atmospheric pressure requirements 120 Authorization to Return Parts 128 Auto logoff 103 Autoflourescence 21 Autof...

Page 138: ... 99 Language 99 Local area network setup 107 Patient ID 106 Patient record management 105 Preview duration 104 Printers 101 102 Printouts 100 Reports 100 Reset to defaults 104 Security 103 Standalone instrument 105 Time zone 99 Configuring Data Backups 51 Copy Annotation 84 Copyright Software 123 D Data Automatic Backup 51 Importing 45 Manual Backup 51 Data analysts Intended demographic 20 Require...

Page 139: ... Annotations 88 Freehand Shape Annotate Image 84 Front lens cleaning the 109 Front Lents 24 Fundus autofluorescence 21 H Help 26 Hide Annotation 84 Hide Annotations 91 Hide Screen 27 Humidity requirements 120 I ID Patient Identifier 99 IEC 60825 1 7 Image brightness 31 Image Brightness Adjustment 92 Image capture 28 Image Color Adjustment 93 Image contrast 31 Image saturation 31 Image sharpness 31...

Page 140: ... Monitor 23 Montage Creating from Saved Images 94 Editing 31 Multi component names 106 Multi Component Names Setting 100 N Name Patient Identifier 99 Network LAN 107 Network drives 107 Network File Server Requirements 108 Networking 32 Notifications Change Volume 27 O OD Changing Laterality 44 Online Help 26 On Screen Keyboard Enable Disable 99 Operation Principles 21 Operator Add New 48 Change Pa...

Page 141: ...t Preparation Optional dilation of the eyes 53 Patient profile 19 Patient window 27 Patients Optional dilation of the eyes 53 Preparation 53 PC 23 Peripherals 23 Permissions Doctor 47 Permissions About 47 Permissions Administrator 47 Power Off 97 Powering down 97 Powering up 39 Preparing the Patient 53 Principles of Operation 21 Print Report 31 Printers Configuring 101 102 Printing Reports 96 Proo...

Page 142: ...tion 31 Specific settings 104 Standalone instrument 105 Startup 39 Static IP address 107 Stereo Image 31 Stereo Images 95 Symbols and Labels 8 System date and time 99 System Startup 39 T Temperature requirements 120 Test Page Printers 102 Text Annotations 84 Theory of operation 21 Time System Setting 99 Toolbar 26 Tools Annotation 84 Arrow 85 Brightness Adjustment 92 Caliper 86 Circle 87 Color Adj...

Page 143: ...Instructions for Use Index CLARUS 500 2660021165005 Rev A 2017 08 143 144 Z Zoom 31 Zoom In Out Annotations 83 ...

Page 144: ... Dublin CA 94568 07745 Jena User Manual USA Germany Specifications subject to change without notice Toll Free 1 800 341 6968 Fax 49 0 7364 20 4823 Phone 1 925 557 4100 Email info meditec meditec zeiss com Fax 1 925 557 4101 Internet www zeiss com med Internet www zeiss com med 2660021165005 Rev A 2017 08 info meditec us zeiss com ...