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Clarity RetCam Shuttle User Manual Download Page 148

Screening for Retinopathy of Prematurity (ROP)

            

147

RetCam 3 and RetCam Shuttle User Manual

PN 18-000393 Rev. A

Based on a review of the RetCam images, Grader C concluded that 40 sets of images had 
Type 2 pre-threshold ROP or Treatment-requiring ROP including all 26 cases determined 
by BIO to be Type 2 pre-threshold ROP or Treatment-requiring ROP. Grader C was able to 
make a determination for all of the sets of images. Eighty (80) sets of images were 
concluded by Grader C to have no ROP or mild ROP.

Table 13

Statistics and 2x2 Cross-Tabulation Components by Grader

* This counts as false positives the 6 sets of images classified as unknown by Grader A 
and 'mild ROP or less' by the reference standard.

** This counts as false positives the 8 sets of images classified as unknown by Grader B 
and 'mild ROP or less' by the reference standard.

Unknowns in this study were treated as false positives (referral-warranted disease) for 
statistical purposes in 

Table 13

 because in the clinical setting such a result would result in 

examination by BIO. None of the BIO referrals were missed by the RetCam Graders 
resulting in 100% sensitivity results for each Grader. Due to “over referral” by two (2) of the 
Graders and the inclusion of unknowns as referrals, specificity results for the graders 
ranged from 85% to 88%.

Image Quality

Before providing a diagnosis for each image set, the three (3) retinal specialist graders 
assessed the technical quality of the images for “adequate”, “possibly adequate”, or 
“inadequate”. Each of them found that images taken at 35-37 weeks PMA by trained NICU 
nurses were technically “adequate” or “possibly adequate” at a rate of 93.3% to 100%.

Table 12c: Cross-classification from Grader C versus BIO (35-37 Weeks PMA)

Grader C

Reference Standard: BIO

Type 2 pre-threshold ROP or 
treatment-requiring ROP

No ROP or Mild ROP

Type 2 pre-threshold ROP or 
treatment-requiring ROP

26

14

Unknown

0

0

No ROP or Mild ROP

0

80

Total

26

94

Table 13: Performance for Type 2 Threshold ROP or Worse

Grader

Sensitivity

~95% CI for

Sensitivity

Specificity

~95% CI for

Specificity

A

1.0 (26/26)

(0.868, 1.0)

0.883 (83/94)*

(0.802, 0.933)

B

1.0 (26/26)

(0.868, 1.0)

0.851 (80/94)**

(0.765, 0.909)

C

1.0 (26/26)

(0.868, 1.0)

0.851 (80/94)

(0.765, 0.909)

Summary of Contents for RetCam Shuttle

Page 1: ...er A M P N A M Supplier P N A M Supplier P N A M Supplier P N ROHS Compliant Yes No N A Approvals CE UL _ CSA _ TUV IEC Other specify _ Shelf Life Yes No If Yes specify Visual Inspection Yes No Dimensional Inspection Yes No Functional Inspection Yes No Certification of Conformance Yes No If Yes specify type _ Standard Unit of Measure Each Inch Foot Millimeter Meter Ounce Other _ Estimated cost per...

Page 2: ... H PVU LKLYHS SH YLZ YPJ Z OPZ KL PJL V ZHSL I VY VU OL VYKLY VM H WO ZPJPHU VY SPJLUZLK TLKPJHS WYHJ P PVULY User Manual PN 18 000 Rev A For use with software version 6 and Ophthalmic Imaging Systems ...

Page 3: ...Copyright 2013 Clarity Medical Systems Inc All rights reserved MediMark Europe S A R L Images on the cover of this manual are representative only 11 rue Emile Zola 38100 GRENOBLE France Tel 33 0 4 76 86 43 22 Fax 33 0 4 76 17 19 82 e mail info medimark europe com ...

Page 4: ...ort the system to another location 34 Electrical Safety Information 35 Class I Type BF Electrical Equipment 35 Rated for Continuous Operation 35 Important User Safety Notices for All RetCam Systems 39 Labels and Symbols 40 Product Labels 43 2 RetCam System Software Configuration 45 Configuring the RetCam System for Use with Optional RetCam Review Software 45 Functions Managed by RetCam Review Soft...

Page 5: ...ng Existing Patient Records 77 Search Results 79 Working with Domains 80 Performing Exams 81 Capturing Images 86 Image Capture Controls 86 Range 88 Footswitch 89 RetCam 3 Control Panel 89 Keyboard Controls 89 Video Playback 89 Saving a Video 90 Using Helpful Features 90 Locating Still Images From Video 91 Changing Image Capture Options During an Exam 91 Changing Right Eye OD Left Eye OS 92 Changin...

Page 6: ... 112 Exporting Images 112 Select Images for Export 112 Select Export Options 115 Select the File Format 116 Format Options 116 Export Image Formats 117 Export Data Formats 117 Complete Export 117 Importing Images 118 Include Subfolders Check Box 121 Delete Source files and Subfolders After Import Check Box 121 Confirm Images and Media Importation 122 8 Printing Images 123 Printing Images and Repor...

Page 7: ...vents 149 12 Maintenance and Support 151 Recommended General Maintenance Schedule 151 Cleaning Procedures 152 Cleaning the Lens Piece 152 Alternate Cleaning and Disinfection 153 Cleaning the Rest of the System 153 Disposal of Materials 153 Cable and Connections Inspection 154 RetCam 3 Maintenance 154 RetCam 3 Fuse Replacement 154 RetCam 3 Illumination Lamp Replacement 156 RetCam Shuttle Maintenanc...

Page 8: ...0 RetCam Shuttle Technical Specifications 171 RetCam Shuttle Hardware Requirements 171 Physical 171 Electrical 171 Notebook Computer 171 RetCam Shuttle Software Requirements 171 RetCam Shuttle Environmental Conditions 172 14 License Agreements 173 Clarity Software Restricted Rights 173 RetCam Software End User License Agreement 173 ...

Page 9: ...8 RetCam 3 and RetCam Shuttle User Manual PN 18 000393 Rev A This page intentionally blank ...

Page 10: ...able 6 Selected Image Filters 78 Table 7 Selected Image Filters 114 Table 8 Format Options for Exam Images 116 Table 9 Export Image Formats for Exam Images 117 Table 10 Export Data Formats for Patient Records 117 Table 11 Configuration Options 127 Table 12 Cross Classification of Graders 146 Table 13 Statistics and 2x2 Cross Tabulation Components by Grader 147 Table 14 Clinical Risks and Recommend...

Page 11: ...10 RetCam 3 and RetCam Shuttle User Manual PN 18 000393 Rev A This page intentionally blank ...

Page 12: ...ities Menu 46 Figure 16 User Preferences Window 46 Figure 17 Domain Selection Menu 47 Figure 18 Select Domain Dialog Box 48 Figure 19 Create Domain Dialog Box 48 Figure 20 Assign Users Dialog Box 49 Figure 21 Manage Users Menu 50 Figure 22 Create User Dialog Box 50 Figure 23 Assign Domains Dialog Box 51 Figure 24 User Preferences Dialog Box 52 Figure 25 Patient Assignment Dialog Box 52 Figure 26 D...

Page 13: ... 56 Patient Directory 79 Figure 57 Patients and Exams Screen Command Buttons 79 Figure 58 Taskbar Showing Sync Enabled 80 Figure 59 Taskbar Showing Sync Disabled 80 Figure 60 Domain Configuration Window 80 Figure 61 Create Domain Dialog Box 81 Figure 62 New Exam Configuration Screen 82 Figure 63 Edit Imaging Configuration 83 Figure 64 Manual Configuration 84 Figure 65 New Exam Screen 84 Figure 66 ...

Page 14: ...5 Figure 100 Color Adjustments Pane 106 Figure 101 Annotations Pane 106 Figure 102 Insert Ellipse Button 107 Figure 103 Insert Line Button 107 Figure 104 Text Overlays Pane 108 Figure 105 General Options Pane 108 Figure 106 Select Patients and Exams for Export 113 Figure 107 Select Images Toolbar 113 Figure 108 Search Results 114 Figure 109 Export Dialog Box 115 Figure 110 File Format Options 116 ...

Page 15: ...arity Method Five Images 145 Figure 141 Inverted Lens Piece Showing Permissible Immersion Depth 153 Figure 142 Power Entry Module 154 Figure 143 Opening the Fuse Holder Cover 155 Figure 144 Removing the Fuse Holder 155 Figure 145 Fuses Removed 156 Figure 146 Fuse Holder Re Inserted 156 Figure 147 Opening the Front Cover 157 Figure 148 Removing the Camera and Focus Cables 157 Figure 149 Front Panel...

Page 16: ...ding retinal corneal and external imaging Photodocumentation of pediatric ocular diseases including retinopathy of prematurity ROP Screening for Type 2 pre threshold retinopathy of prematurity ROP zone 1 stage 1 or 2 without plus disease or zone 2 stage 3 without plus disease or treatment requiring ROP defined as Type 1 ROP zone 1 any stage with plus disease zone 1 stage 3 without plus disease or ...

Page 17: ...l practitioner RetCam devices are intended for use by individuals knowledgeable and skilled in the use of ophthalmology devices including physicians nurses ophthalmic photographers and ophthalmic technicians Special instructions addressing the use of the device with infants are found in this user manual in Chapter 11 Screening for Retinopathy of Prematurity ROP on page 141 Prior to using the syste...

Page 18: ...Use care when imaging the eye that is use the least amount of pressure and movement necessary Make sure that the lens tip is immersed in coupling gel and does not contact the eye directly Clarity recommends GenTeal Gel which is available in the United States Outside the United States Clarity recommends either Viscotears or Vidisic Ensure the camera is supported held in a manner that does not put d...

Page 19: ...red if the RetCam System is unavailable or if the image detail in the area of interest is unsatisfactory for any reason RetCam 3 System Hardware The RetCam 3 system consists of modules mounted in a stable high quality integrated mobile cart for easy safe transport from one location to another The four casters allow for easy maneuverability and positioning Figure 1 on page 19 and Figure 2 on page 2...

Page 20: ...only Display Handpiece with Interchangeable Holster Handpiece Cable FA Light Connector Storage Drawers Footswitch DVD writer inside drawer Membrane Control Panel Lockable Casters Transport Handle Printer on Footswitch Storage Pocket Extended Shelf Keyboard Mouse Input Shelf extended USB port Cord Wrap Post both sides FA Light Switch FA Intensity Control with Connectors Lens Piece contains 4 USB po...

Page 21: ...on RetCam 3 and RetCam Shuttle User Manual PN 18 000393 Rev A Figure 2 RetCam 3 Ophthalmic Imaging System Rear View1 1 Image shown is representative only Ethernet Port Product Label Main Power Switch and Power Cord Connection ...

Page 22: ...al means to capture videos or still images Storage Drawers All units have two storage drawers for lens pieces tools and supplies Fluorescein Angiography FA Source optional An optional blue exciter light source is available for FA digital photography It comes complete with a yellow barrier filter for the handpiece The only way to adjust FA illumination intensity is by using the intensity control kn...

Page 23: ...cus connector or the Camera Handpiece connector remove the front cover panel The Handpiece Focus connector is a direct insert receptacle for insertion of the white focus motor cable which is part of the handpiece interconnect harness To insert the cable align the red dot on the connector with the red dot on the Focus port and insert To detach pull back on the connector being careful not to pull on...

Page 24: ...en screw to secure To detach unscrew counterclockwise the connector sleeve and pull out Figure 4 Inside Connector Notch Figure 5 CEO Box Notch Figure 6 Handpiece and Lenspiece Handpiece Lens piece Handpiece interconnect harness Lens Model Application Common Field of View D1300 Premature Infant 130 Degrees B1200 Standard Baby 120 Degrees E800 High Contrast Children Adults 80 Degrees C300 High Magni...

Page 25: ...nical Services for instructions on packaging and transporting the system to another location outside the hospital To relocate the system within a building 1 Power down the system through the software by selecting and then Shutdown 2 Switch OFF mains power on the back of the unit Unplug the power cord from the wall outlet and drape it over the transport handle 3 Secure the handpiece in its holster ...

Page 26: ... with protective earth To avoid risk of electric shock inspect cables and electrical cords for damage prior to use IEC 60601 1 2005 Corrigendum 1 Corrigendum 2 Accessories equipment connected to the analog and digital interfaces must be certified to the respective IEC standards i e IEC60950 for data processing equipment and IEC 60601 1 for medical equipment Furthermore all configurations shall com...

Page 27: ...an domestic and may be used in domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes provided the following warning is heeded Warning This equipment system is intended for use by health care professionals only This equipment may cause radio interference or may disrupt the operation of nearby equipment ...

Page 28: ...0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s Mains power quality should be that of a typical commercial or hospital environment If the user of the RetCam device requires continued operation during power mains interruption...

Page 29: ...nt Connect the equipment into an outlet on a circuit different from that to which the other device s are connected Consult the manufacturer or field service technician for help An error message may be displayed which then may require a system reset To perform a system reset press the system power switch on the control panel for 6 seconds until the system powers down then press the switch again to ...

Page 30: ...ility and positioning Figure 8 on page 29 and Figure 9 on page 30 illustrate the system hardware Figure 8 RetCam Shuttle Imaging System1 1 Image shown is representative only Handpiece with Holster Lens storage box Secondary Work surface Lower door Internal handpiece Upper door Electro Optical EO box footswitch storage Notebook Computer open work surface Container for lens piece tools and supplies ...

Page 31: ... damage to the fiber optic cable might result Or store the handpiece with a lens in the internal handpiece storage compartment Electro Optical EO Box Contains the illumination port and the control circuitry See The Electro Optical Box EO Box on page 31 for more details Footswitch Provides the means to control illumination intensity and camera focus The Footswitch provides an optional means to capt...

Page 32: ...reen This section describes its components and their functions Figure 10 Electro Optical EO Box NOTE It is not necessary to remove any of the connectors for storage or transportation Do not remove any connections while the system is powered ON The main power switch must be OFF prior to connecting or disconnecting any cables from the EO box Do not look directly into the Lamp Fiber Optic opening whe...

Page 33: ... back on the connector being careful not to pull on the cable The focus connector is not threaded The Camera Handpiece connector is a receptacle for insertion of the black camera controller cable which is part of the handpiece interconnect harness To insert the camera handpiece connector align the notch on the inside connector Figure 11 on page 32 with the notch on the EO box Figure 12 on page 32 ...

Page 34: ...en hospitals clinics and offices NOTE The system has no internal power supply no battery to support image acquisition when disconnected from a wall outlet The notebook computer can operate using its own battery To relocate the system within a building 1 Power down the system through the software by selecting and then Shutdown 2 Switch OFF mains power on the back of the unit Unplug the power cord f...

Page 35: ...sport handle or store the power cord inside the cart 3 Carefully remove the lens and store it in the lens box Secure the handpiece and footswitch in their storage compartments in the cart 4 Remove the notebook computer from the work surface and carry it separately 5 Close the cart doors Unlock the caster brakes 6 Extend the transport handle upward and use it to tilt the cart and roll it to a vehic...

Page 36: ...with protective earth To avoid risk of electric shock inspect cables and electrical cords for damage prior to use IEC 60601 1 2005 Corrigendum 1 Corrigendum 2 Accessories equipment connected to the analog and digital interfaces must be certified to the respective IEC standards i e IEC 60950 for data processing equipment and IEC 60601 1 for medical equipment Furthermore all configurations shall com...

Page 37: ... than domestic and may be used in domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes provided the following warning is heeded Warning This equipment system is intended for use by health care professionals only This equipment may cause radio interference or may disrupt the operation of nearby equipme...

Page 38: ... in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 Mains power quality should be that of a typical commercial or hospital environment If the user of the RetCam device requires continued operation during power mains interruptions it is recommended that the RetCam device be powered from an uninterruptible power supply or a battery Power Frequency 50 60 Hz magnetic field EN ...

Page 39: ...a system reset To perform a system reset press the system power switch on the Notebook for 6 seconds until the system powers down then press the switch again to power the system back on Do not use the hard shutdown method unless necessary because it can cause data corruption For continued protection against risk of fire replace only with same type and rating fuse NOTE The notebook computer provide...

Page 40: ...The RetCam 3 system is not intended to be transported outdoors 8 Newly acquired data can be lost if power is interrupted during live imaging NOTE Backup battery power on the RetCam 3 system is available for at least 15 minutes after interrupt 9 The system comes protected from viruses worms and spyware with Microsoft s anti malware Please refer to the warranty or contact Clarity Technical Services ...

Page 41: ...to light source Intensity Controls light or illumination Snap capture still images and start or pause video capture switch Read instructions Warning Electrical hazard High voltage in the FA unit RetCam 3 Chassis ground RetCam 3 AC DC Power Indicator RetCam 3 The light is solid green when the system is plugged into AC power and flashing green when the system is powered by the battery Protective ear...

Page 42: ...indicated type Do not use any other type RetCam Shuttle Backup battery Computer network RetCam 3 Non ionizing radiation FA Fluorescein Angiography RetCam 3 FA Intensity increase clockwise RetCam 3 FA light OFF RetCam 3 FA light ON RetCam 3 Light source fiber optic connector Handpiece connector USB connector Fragile contents Shipping Label This side of carton up Shipping Label ...

Page 43: ...d part is handpiece To prevent damage to lens piece carefully store handpiece in holster when not in use Clean lens piece after use Separate collection of waste at end of life as required by European directives Contact Clarity for equipment disposal instructions European conformity North American compliance certification Serial number Date of Manufacture Footswitch Degrees of Protection Provided b...

Page 44: ...Introduction 43 RetCam 3 and RetCam Shuttle User Manual PN 18 000393 Rev A Product Labels RetCam 3 RetCam Shuttle ...

Page 45: ...44 Chapter 1 Introduction RetCam 3 and RetCam Shuttle User Manual PN 18 000393 Rev A This page intentionally blank ...

Page 46: ...uire RetCam Administrator privileges Configuring the RetCam System for Use with the Optional RetCam Review Software RetCam Review Software RCRS is a separate Clarity product RCRS provides a facility to store and access patient data and images over the Internet RCRS is designed to communicate with RetCam 3 or RetCam Shuttle Ophthalmic Imaging Systems running software version 6 0 or above If your in...

Page 47: ... configure the RetCam 3 or RetCam Shuttle for use with RCRS select the gear icon on the bottom right of the screen to display the Utilities menu and then select User Preferences Figure 15 Utilities Menu When the User Preferences window appears select Synchronization to display the options for RCRS Figure 16 User Preferences Window Check the Enable Synchronization checkbox and enter the name or IP ...

Page 48: ...ystem is configured for use with RCRS the following functions are disabled on the RetCam System Create Domain Delete Domain Create User Modify User These functions are managed on the RCRS application and those settings are applied to the RetCam system via the synchronization process Creating Domains A domain is a collection of patients Domains can be structured to suit your institution s preferenc...

Page 49: ...ended to be connected to RCRS complete steps 1 through 6 on pages 48 49 to create domains At least one domain is required on the RetCam System The first time that the RetCam Administrator logs in to the RetCam System the system displays the Select Domain dialog box Figure 18 Select Domain Dialog Box 1 Click to display the Create Domain dialog box Figure 19 Create Domain Dialog Box 2 Enter data in ...

Page 50: ...on Institution Department Group Study 3 Click to display the Assign Users dialog box Figure 20 Assign Users Dialog Box 4 Use the Assign Users dialog box to assign users to domains The Available Users pane displays all users who were created on the RetCam System The Assigned Users pane displays all users who were assigned to this domain 5 Click to return to the Create Domain dialog box 6 Click in t...

Page 51: ...ts and Exams screen appears To create a user ID click the Utilities menu located on the right side of the task bar then select Manage Users followed by Create User Figure 21 on page 50 Figure 21 Manage Users Menu The Create User dialog box appears Figure 22 Create User Dialog Box The required fields are indicated with a yellow asterisk Complete the First Name Last Name Log In ID Password Re enter ...

Page 52: ...omatically added to the domain in which the patient is created See Add a New Patient Record on page 75 To add an existing patient to additional domain s first determine if the patient belongs to a domain that you can access by searching all available domains for that patient If you can access the patient you can assign the patient to other domains that you can access If you can not access the pati...

Page 53: ...ead to patients becoming inaccessible The Domain List pane displays all domains that the current user can access You can select only one domain at a time The Patient List pane displays all patients in all domains that the current user can access You can select multiple patients by holding down the Shift key on the keyboard and at the same time selecting the desired patients Click to assign the sel...

Page 54: ...st pane displays all patients in all domains that the current user can access You can select only one patient at a time The Domain List pane displays all domains that the current user can access You can select multiple domains by holding down the Shift key on the keyboard and at the same time selecting the desired domains Click to assign the selected patient to the selected domain s Click to retur...

Page 55: ...54 Chapter 2 RetCam System Software Configuration RetCam 3 and RetCam Shuttle User Manual PN 18 000393 Rev A This page intentionally blank ...

Page 56: ...s configured for use with RCRS look in the upper right corner of the Patients and Exams screen and find If the Sync button is blue as shown the system is configured for use with RCRS To determine if the RetCam system is currently connected to RCRS look in the bottom right corner of the Patients and Exams screen and observe the Server Connection status Figure 27 on page 55 Figure 27 Server Connecti...

Page 57: ... the RetCam system before removal of image or video files from the RetCam system Synchronization with RCRS You can synchronize your RetCam System to RCRS when the Server Connection status indicates the RetCam system is connected To synchronize with RCRS follow these steps 1 Select the desired domain from the domain selection list Figure 28 Domain Selection List 2 Click The Sync button is enabled l...

Page 58: ... Clarity recommends that each institution develop consistent data entry processes to minimize the creation of duplicate patients or users NOTE Data that requires synchronization with RCRS is identified by the Sync Required value in the Sync Status column The Sync Required status also appears in the Domain Selection screen displayed during user login and in the Domain menu on the Patients and Exams...

Page 59: ...data is edited on both the RetCam System and RCRS In this case you must determine which data is correct and then update it on both the RetCam System and RCRS The Reconciliation Form displays two columns one column for each data source the RetCam Server and the local device Each row in the form contains an un reconciled data element for example classification Clicking on the cell with the desired d...

Page 60: ... List for that patient exam or image must be addressed After making selections for all un reconciled data elements the RetCam System signals potential reconciliation resolution by displaying all data cells in a different color Figure 31 on page 59 Figure 31 Reconciliation Form Reconciled To complete reconciliation of the synchronization click This action results in a confirmation window requesting...

Page 61: ...current domain is displayed in the Reconciliation Form as long as it remains un reconciled NOTE During synchronization and reconciliation other RetCam systems connected to the same RCRS Server cannot begin the synchronization process Only one RetCam system connected to the same server can synchronize at any one time Data that is not reconciled during synchronization displays the Sync Required stat...

Page 62: ...tCam A thumbnail image remains on the RetCam for reference after the full size image or video is removed NOTE On the Patients and Exams screen the thumbnail of the removed image displays Not on Device to indicate that the full size image has been removed NOTE The Exam Review screen displays Image Not Available if the thumbnail is selected to indicate that the full size image has been removed To re...

Page 63: ...62 Chapter 3 Synchronization with RetCam Review Software RCRS RetCam 3 and RetCam Shuttle User Manual PN 18 000393 Rev A This page intentionally blank ...

Page 64: ... for using an installed system which has the main power printer RetCam 3 and monitor turned ON the monitor height adjusted RetCam 3 and software installed and configured for the site It might also be necessary for the RetCam Administrator to grant domain access for individual users before clinically trained users can begin patient imaging NOTE The software is preinstalled on the system and a recov...

Page 65: ...of system status Figure 34 on page 64 3 Depress the System Power button located on the Control Panel to turn ON system power This action illuminates the System Power indicator light solid green and initializes the software Figure 34 Control Panel Figure 35 Footswitch Controls Illumination ON Lamp Illumination System Power System Power button Relative intensity indicator Intensity Controls Focus Co...

Page 66: ...ndpiece as shown in Figure 36 on page 65 Fit the lens piece on the handpiece aligning the 3 radial pins on the front of the handpiece with the spaces between the tabs of the spring ring on the lens piece Twist the lens piece clockwise as shown in Figure 36 on page 65 until you hear a click indicating that the lens piece is locked in place Handpiece Connection Verify that the handpiece is connected...

Page 67: ... do not wrap it tightly because damage to the fiber optic cable might result Printer Setup Extend the printer shelf fully and verify that sufficient paper is installed in the printer Lift printer lid to ensure ink cartridges are installed Push the shelf back in System Software When the software is ready the User Login screen appears Figure 38 on page 66 Figure 38 User Login Screen Enter the userna...

Page 68: ... Screen The Select Domain screen displays the domains available to you Click the desired domain to complete the login process Fluorescein Angiography For FA operation if available see Chapter 10 Fluorescein Angiography RetCam 3 System on page 135 for instructions Illumination Lamp If the illumination lamp is OFF press the Lamp Illumination button located on the right side of the Control Panel to t...

Page 69: ...Cord and Power Connector The main power switch is located above the power cord inlet It must be in the ON position to operate the system NOTE Place components and cabling in a manner to prevent hazards to users or equipment NOTE Do not switch OFF or disconnect main power during imaging doing so might cause data corruption Figure 41 Main Power Switch On Switch shown off Off ...

Page 70: ...ect the notebook computer to the notebook power supply cable and the USB video input cable unless already connected Figure 43 Computer Power and USB Video Cables Focus Controls Snap toggle switch single image Snap or start or pause video capture Illumination intensity controls Notebook power supply cable USB 1 Cable USB 2 Cable ...

Page 71: ...lamp indicator illuminates and you hear the internal fan Power ON the notebook computer The system is ready when you see the User Login screen Figure 46 on page 72 Connect this equipment using the power cord supplied by Clarity or agency listed power cord for the country of use To avoid the risk of electric shock this equipment must be connected to a supply main with protective earth NOTE The syst...

Page 72: ... on the front of the handpiece with the spaces between the tabs of the spring ring on the lens piece Twist the lens piece clockwise as shown in Figure 45 on page 71 until you hear a click indicating that the lens piece is locked in place To mitigate the potential for excess light exposure to the patient during imaging always start at the lowest light intensity level and increase if necessary Use o...

Page 73: ...er Login Screen Enter the username and password assigned by your RetCam Administrator Figure 47 Change Password Dialog Box The first time that you log in to the RetCam system you must change the password that was assigned by the RetCam Administrator Figure 48 Select Domain Screen The Select Domain screen displays the domains available to your Log In ID Click the desired domain to complete the logi...

Page 74: ...ge 90 Changing Image Capture Options During an Exam on page 91 Adding Exam Notes on page 92 Turning OFF the RetCam 3 System on page 96 Turning OFF the RetCam Shuttle System on page 98 Managing Patient Records This section describes how to add a new patient and locate the records for an existing patient The software is ready to use when you see the Patients and Exams screen shown in Figure 49 on pa...

Page 75: ...r imaging session Look at images for a selected patient and date Add a new patient record to the database Edit an existing patient record Add notes to an existing patient record Notes are date stamped with the date they are created You cannot edit notes after they are saved Add notes to an existing patient exam Notes are date stamped with the date they are created You cannot edit notes after they ...

Page 76: ...e or printing Dark grey buttons represent creation of patient notes or exam notes Light grey buttons indicate functions that are disabled Add a New Patient Record Click to display the New Patient screen Figure 50 Add New Patient Screen Import patient data from CD USB drive network etc Only mlx or dcm formatted images can be imported Export patient data Synchronize patient and exam data with the Re...

Page 77: ...cord Figure 51 Patient Information Required patient information First Name Given Name Last Name Family Name Patient ID Figure 52 Birth Information The date of birth is required Enter it manually or select it from the drop down calendar Editing a Patient Record To edit a patient record either select the patient record and click or double click the patient s record from the Patients and Exams screen...

Page 78: ...ou can search for specific patient records by name with or with a date filter and with or without additional filters As in the manual search the first step is to select the appropriate domain from the drop down menu in the Domain field on the Patients and Exams screen Remember that your Log In ID profile determines which domains are available to you The following are optional filters within the Si...

Page 79: ...al patient or a group of patients using one or more of the advanced search options shown in Figure 55 on page 78 Click to clear all search fields Filter Name Filter Hover Text Filter Description All Selects all records None Clears all selected records Flagged Selects all of the flagged images Today s Selects all of the images captured today on the current date This Week s Selects all of the images...

Page 80: ...age Ethnicity and Salutation Click next to a patient name to start a new exam for that patient Click next to an exam to show thumbnails Eye identifier Lens used and Image type Click next to an exam to view additional exam information Exam weight Number of stills Number of videos and Location From the Patients and Exams screen use the buttons shown in Figure 57 on page 79 to work with patient and e...

Page 81: ...ot enabled the taskbar displays the message Server connection not enabled The Space Used graphic indicates the space available on the RetCam system Working with Domains Click in the task bar at the bottom of the Patients and Exams screen and select User Preferences to access the Domain Configuration window Figure 60 on page 80 Figure 60 Domain Configuration Window To create a domain on the RetCam ...

Page 82: ...erforming Exams You can use the RetCam system to capture still images or video after selecting a patient Never connect the RetCam system to a network or any externally powered devices or peripherals during imaging RetCam 3 system power from a fully charged battery is available for a minimum of 15 minutes after an AC main power loss In the event of an AC power loss we strongly suggest that you comp...

Page 83: ... Weight field shown in Figure 62 on page 82 appears only when the patient is less than one year old NOTE The New Exam Configuration screen displays the storage capacity of the system hard drive Figure 62 on page 82 The total number of images that can be saved is affected by saving a combination of videos and stills and by saving images with annotations To edit any of the Preset Configurations 4 Se...

Page 84: ...1300 1200 800 300 Unspecified Eye Right OD Left OS Unspecified Footswitch Video Rec Save Still Figure 63 Edit Imaging Configuration 6 Click to save the configuration and close the window To edit the Manual Configuration 7 Click to open the Manual Configuration menu Note that the menu appears above the Manual Configuration bar in the New Exam Configuration screen ...

Page 85: ...capture controls patient information thumbnails of the captured images and buttons to control the screen display and other functions If change is required from what was previously selected as a preset or manual configuration then toggle or to use the green button on the footswitch either to capture and pause video or to save stills Click to display configuration options Figures 67 69 on page 85 Cl...

Page 86: ...Dialog Box Figure 67 Configure Playback Click the arrow to expand the menu and then select the desired video playback speed Click Done to close the dialog box Figure 68 Configure Color Mode Color Mode refers to normal image capture mode which is always in full color Select a button to position the timer on the image Select or deselect the check boxes to include or exclude detailed information elap...

Page 87: ...xam and then capturing still images from the video particularly in imaging awake patients You can delete the video prior to exiting the exam capture session after the exam is finished and you have extracted and saved still images The maximum video file size is configurable By default approximately 2 minutes can be recorded per video To change the file size see Configuring Live Imaging on page 129 ...

Page 88: ... any timer button to display the menu of timer options Figure 71 on page 87 Figure 71 Timer Menu Options Click or to turn fluorescein angiography imaging on or off in the software see Chapter 10 Fluorescein Angiography RetCam 3 System on page 135 Images are monochromatic in FA mode A progress bar appears below the Image Capture Controls each time that you start Record Video to capture video It sho...

Page 89: ... of the image The Range function adjusts the black level to ensure that the black areas display as truly black when using gamma correction Click to set range level Click to turn off range Figure 73 Range Levels Range has five 5 different levels of image correction available for user selection 0 off 25 50 default 75 and 100 Each of these settings corresponds to a unique combination of adjustment se...

Page 90: ...ntrols Toggle or to or Next use the footswitch Snap button or the S key to record pause and restart video recording or capture a still image RetCam 3 Control Panel Select one or more options from the onscreen image capture controls Figure 70 on page 86 adjust the focus and intensity using the control panel Figure 34 on page 64 then press the green Snap button on the control panel to start or pause...

Page 91: ... on page 85 NOTE The space bar plays and pauses video The left and right arrow keys on the keyboard move the video back or forward one frame at a time Click to return to the live capture screen Saving a Video By default exiting the exam deletes all videos recorded To save a video display the thumbnail view and uncheck the delete icon on the thumbnail view The delete icon toggles so clicking it aga...

Page 92: ...Snap button on the control panel or the footswitch NOTE To capture still images from video ensure the is configured for capturing still images 2 Use the playback controls at the top of the screen to locate a still image Start playback by clicking Play or Forward one frame To move the video one frame back click Click Pause when you see an image you want to save Click or press S on the keyboard or p...

Page 93: ...maging session When you exit the session all images and videos not marked for deletion are automatically saved By default videos are marked for deletion when you exit an imaging session For instructions on saving videos see Saving a Video on page 90 Changing Image Type Expand the Type menu to label images as Retina Anterior or Unspecified during an imaging session All selections record the images ...

Page 94: ...m Notes During Exam Screen There is a notes field for each eye To add notes 1 Click to activate the notes fields 2 Expand the Creator menu to select the note author This list is populated with the clinician information stored in the RetCam Figure 78 Creator Menu 3 Click to display the Edit Clinician dialog box Figure 79 Edit Clinician Dialog Box 4 Click to add new clinician information ...

Page 95: ...een Click to exit exam and go to patient exam review screen Click to cancel the edits to the note The following message appears Click to lose all changes You can also add notes from the Image Review screen Once saved the text cannot be modified You can append text to notes from the Review Compare and Image Process screens by clicking Notes are identified by date time and person who created the not...

Page 96: ...ield for each eye To add notes 1 Click to activate the notes fields 2 Expand the Creator menu to select the note author This list is populated with the information stored in the RetCam Figure 82 Creator Menu 3 Click to display the Edit Clinician dialog box Figure 83 Edit Clinician Dialog Box 4 Click to add new clinician information ...

Page 97: ...when you add notes NOTE You cannot change a note after you click Other options Click to clear all fields Click to cancel any notes The following message appears Click to lose all changes Click to proceed with changes A screen appears confirming changes Figure 85 Save Confirming Changes Turning OFF the RetCam 3 System NOTE We strongly suggest that you backup and store your data prior to turning OFF...

Page 98: ...5 If the FA module is installed verify that the FA power switch is OFF 6 Carefully inspect and clean the lens piece Store the lens in the cart storage drawer or attach it to the handpiece If you store the lens in the cart storage drawer place protective caps on the handpiece and lens 7 Return the handpiece to the holster 8 To turn off the main power move the main power switch located on the rear o...

Page 99: ...to turning OFF the system Figure 88 Shutdown Icon 1 Select the red shutdown icon at the bottom right corner of the screen Figure 89 Shutdown Options Select the Shutdown option NOTE If the computer stops responding wait at least one minute to make sure that the system is not busy If the system is still not responding press the power ON button on the Notebook computer for 6 seconds until the system ...

Page 100: ...re available for review and comparison This section covers the following topics Exam Review Screen on page 99 Compare Mode on page 103 Image Adjustment on page 105 Exam Review Screen The Exam Review screen appears optionally when you exit live imaging You can also access it by clicking on the Patients and Exams screen Figure 90 Exam Review Screen ...

Page 101: ...name and exam date are highlighted in the Exam Selector Figure 91 Exam Selector Select a different exam to review by clicking the arrows next to Exam Date By default thumbnails for all images acquired in the selected session appear along the bottom of the screen The currently selected image the first one by default appears full size Click on a thumbnail to display the full resolution image Use the...

Page 102: ...o Figure 94 Video Playback Controls These buttons have the same functions for playback as for live imaging Click Play to start playing video The following options are available on the Exam Review screen Configure Options Click to display two option tabs in either the single patient review screen or compare mode Figure 95 Configure Playback From the Playback tab you can select a video playback rate...

Page 103: ...nt image as an image of special interest To unflag an image click the icon again The icon toggles between flagged and unflagged A flagged image is one you might want to review at a later date or select for batch export Full Screen Click to display a full screen view of the current image with no thumbnails visible Normal Screen Click to return to normal screen view with thumbnails visible and curre...

Page 104: ...ssion and return to the Patients and Exams screen Compare Mode The Compare screen appears when you click Use the Compare screen to compare any two images You can compare images from one or more exams for a single patient or from two different patients Figure 97 Compare Images One Patient The last image displayed on the Exam Review screen appears on the left side of the Compare screen On the right ...

Page 105: ...are videos Figure 98 Compare Images Two Patients When you compare images from two patients the patient and exam information appears above each image and thumbnails are below the default image The options available for a single patient image review are available for each image The following functions and controls available on the image display screen are not available on the Compare screen Flag Ima...

Page 106: ... hidden pane click at the top left of the pane To exit the Image Adjustment window click in the upper right corner of the window Use the slider bars in the Color Adjustments pane to adjust the brightness contrast and color of the image display Use the buttons in the Annotations pane to add a note or graphic elements to an image Use the scroll slider to zoom in or out Select fields in the Text Over...

Page 107: ...mages Click to apply saved values to the current image Image display adjustments are applied to all images in the current image processing session until you save new settings or click in the General Options pane which resets all parameters to zero Image adjustments apply only to the display To save a copy of an image with image adjustments see Additional Options on page 108 When you leave the curr...

Page 108: ...t the text associated with an annotation double click the text box labeled Type Here to select it and type the desired text Figures 102 and 103 on page 107 Figure 102 Insert Ellipse Button To move an ellipse click the center handle and drag it to the desired location To re size an ellipse click a handle on the perimeter of the ellipse and drag it to the desired size Figure 103 Insert Line Button T...

Page 109: ...on stored in the database To display that information as a text overlay on the image select one or more of the available fields Name Patient Initials Patient ID Date of Birth Exam Date Image Number Image Type Eye Lens Pathology Classification Department Institution Click a location option to choose where the information appears on the image Additional Options The General Options pane offers some a...

Page 110: ...tton Click to save a copy of the current image with all the changes you have made NOTE You can save processed images only outside the RetCam database and in a non proprietary format such as PNG or JPG Images you save from the Image Adjustment window reflect image display adjustments and all other changes you make but the original images in the database are not changed ...

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Page 112: ...e local hard drive It is highly recommended to create a central repository on a network of all data in the MLX format from the RetCam device for long term data backup NOTE Recommended Backup Frequency Each day that you acquire new images Backup Recommendation Network or Removable USB Storage Device For long term backup when not using RCRS we recommend backing up to another computer on your office ...

Page 113: ...age devices require special formatting before use with RetCam systems and we recommend purchasing pre formatted USB devices directly from Clarity Call 1 800 215 6005 toll free in the US and ask for part number 03 12 025 If you experience problems with your USB storage device contact Clarity Technical Services See complete Clarity Technical Services Contact Information on page 167 Exporting Images ...

Page 114: ...white boxes on the right side of the display to select files for Export To select all patients records and exams click All in the Select Images toolbar Figure 107 Select Images Toolbar You can select patients exams and images within the current domain by using the predefined options from the Select Images toolbar Selected Image Filters on page 114 ...

Page 115: ...tem software version 6 x can be imported into legacy RetCam system software versions 4 x and 5 x only 4 The Export dialog box appears Filter Name Filter Hover Text Filter Description All Selects all records None Clears all selected records Flagged Selects all of the flagged images Today s Selects all of the images captured today on the current date This Week s Selects all of the images captured th...

Page 116: ...ure by using User Preferences Figure 124 on page 128 NOTE The Minimum Required Space for Export is displayed Verify that the export destination has sufficient free space to accept the exported files We recommend that you do not export more than 2000 images in one batch because the export takes a long time We recommend that multiple smaller transfers be executed Select Export Options To change the ...

Page 117: ... system Figure 111 Select Image and Data Format Table 8 Format Options for Exam Images MLX Clarity s proprietary encrypted data format DICOM DCM DCM is the filename extension for patient data files that are compatible with the DICOM Digital Imaging and Communications in Medicine standards for ophthalmology Split File Format If you select this format you have additional options for the Export Image...

Page 118: ...ully copied Figure 112 Export Progress Dialog Box Table 9 Export Image Formats for Exam Images PNG Portable Network Graphic uses compression to reduce file size about half the size of a bitmap file but without loss in quality or resolution It can be viewed in a standard web browser and used in image processing or viewing applications JPG or JPEG This format uses compression to reduce file size whi...

Page 119: ...single batch is 2000 images It is strongly recommended that you limit batch size by importing images from one patient at a time and by selecting only the images required for your immediate needs NOTE Files imported to RetCam Review Station version 4 1 or RetCam 5 x can be exported as MLX files and then imported into RetCam system software version 6 x To import legacy pre version 4 x RetCam still i...

Page 120: ...ck Figure 113 Start Screen 2 The Removable Drives dialog box appears Figure 114 Importing from Removable Drives Select if a removable drive local hard drive or network drive is connected If no drive is connected select or to exit The Please connect your removable drive before importing message appears Figure 115 Please Connect Your Removable Drive Message Connect a removable drive ...

Page 121: ...ce location select to expand the path list or click to access the Windows system desktop The Windows system desktop can also be accessed using the source location window Use either interface to navigate to the desired source folder see Figure 117 on page 120 Click to reset the source location to the default setting Figure 117 Import Review Show Details Dialog Box 5 When the desired Source location...

Page 122: ... after import is complete NOTE Do not select this check box if you or others want to import the same data to another RetCam station which would be the case especially if you are importing from the backup repository 6 Click to initiate importing or to cancel the import A window opens to show import progress Figure 118 Importing in Progress 7 Clicking during the import process halts the process and ...

Page 123: ...18 000393 Rev A Figure 119 Import Report Confirm Images and Media Importation 1 Click to close the Import Report window Figure 119 on page 122 2 From the Patients and Exams screen click 3 Confirm the patient and exams are present by selecting and expanding the desired patient record ...

Page 124: ...am System to a network or any externally powered devices or peripherals during imaging You can Print Images from the following screens Exam Review screen Compare screen Patients and Exams screen Print images reports or both NOTE The default image size is 5 inches x 7 inches For optimal resolution Clarity recommends printing images at 5 inches x 7 inches or smaller This size also conserves printer ...

Page 125: ... Purchase replacement photo paper and ink cartridges from Clarity or from a local supplier Locations Outside the United States The RetCam 3 system ships with photo paper only The RetCam 3 device does not ship with an ink cartridge Photo paper and ink cartridges must be purchased locally NOTE Network printers used with the system must have a printer driver supported by Windows 7 Be aware that you m...

Page 126: ...iguring Windows Preferences on page 132 Select the Utilities menu located in the lower right hand corner of the task bar see Figure 15 on page 46 or Figure 121 on page 125 It provides access to information about RetCam software and user preferences as well as other system related information Figure 121 Accessing User Preferences About RetCam Software Click About to identify the RetCam software ver...

Page 127: ... from the Utilities menu see Figure 121 on page 125 For all windows in the User Preferences section click to save any changes that you made and keep the window open Click to save changes and close the window Click to close the window without saving any changes that you made since the window was opened or since the last time you clicked After opening a window if you are unsure of any change that yo...

Page 128: ...software version 5 x and earlier Table 11 Configuration Options Configuration Configuration Description Device Contains the Device name and Serial Number Domain Configuration Manage Domain details and Patient Domain assignments Image Audit Not available Imaging Adjustment Not available Live Imaging Configure Camera Device and Live Imaging File Size New Exams Set the Pre set Imaging Configurations ...

Page 129: ... enable or disable the use of Advanced Encryption Domain Configuration Manage domain details along with patient and domain assignments Figure 125 User Preferences Domain Configuration After making any changes click to save the changes or to close the window Click to exit the window Image Audit The Image Audit options are not available in this release ...

Page 130: ...erences Image Audit Click to exit the window Imaging Adjustment The Imaging Adjustment options are not available in this release Figure 127 User Preferences Image Adjustment Click to exit the window Configuring Live Imaging This window allows you to configure the video file size used for live imaging ...

Page 131: ...to close the window without saving changes Click to save changes and exit the window Configuring New Exam Defaults Use this window to set the defaults for up to three 3 preset exam configurations Figure 129 User Preferences New Exam After setting up one or more exam configurations click to save the changes or to close the window without saving the changes Click to save changes and exit the window ...

Page 132: ...files Figure 130 User Preferences Notification After configuring the message and log file options click to save the changes or to close the window without saving changes Click to save changes and exit the window Configuring Printers This window allows the default printer identification along with default paper size to be set for both the Imaging Printer and the Report Printer Figure 131 User Prefe...

Page 133: ...sable the synchronization functionality If you enable synchronization you must also configure the synchronization server The synchronization feature works only with the RetCam Review Software RCRS Figure 132 User Preferences Synchronization After making any changes click to save the changes or to close the window without saving the changes Click to save changes and exit the window Configuring Wind...

Page 134: ...er Manual PN 18 000393 Rev A Figure 133 User Preferences Windows Configuration After making any changes click to save the changes or to close the window Click to exit the window NOTE Use Printer window Figure 131 on page 131 to configure printer options ...

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Page 136: ...meters The barrier filter inserted in the handpiece has a cutoff wavelength at 510 nanometers or shorter The FA dye absorbs the blue light and emits green light longer than 510 nanometers so the RetCam 3 camera can image the green fluorescence without being overwhelmed by the blue excitation light Using Fluorescein Angiography FA Mode NOTE The internal backup battery never powers the FA module The...

Page 137: ...ize Figure 136 on page 138 4 Click Confirm the button label has changed to Capture a red free image recommended NOTE Certain FA models include a warning LED between the Fiber Optic connector and the intensity adjustment knob 5 Carefully install the barrier filter into the handpiece Figure 135 on page 137 a Remove the lens piece if present b Insert the barrier filter into the cavity of the handpiec...

Page 138: ... 000393 Rev A Figure 135 Barrier Filter Installation NOTE If lenses are exchanged during an FA session hold the camera upright to prevent the barrier filter from falling out during the exchange Lens piece Handpiece Barrier filter Rubber O ring toward lens piece Beveled edge toward handpiece ...

Page 139: ...n in Figure 136 on page 138 NOTE You cannot adjust the FA lamp light intensity by using the footswitch or control panel controls 9 You can take still photos or video during the FA session and you can save still photos during video replay 10 When the FA session is completed a Move the fiber optic cable back to the white fiber optic lamp connector and switch OFF the FA power b Remove and store the b...

Page 140: ... failure Do not attempt to override the interlock switches or to operate in FA mode with the cover off The FA contains internal sources of high voltage high current heat and moving parts Only authorized technicians can attempt any service or repairs to the FA Failure to observe this warning could result in injury to operator or patient Certain FA models include a warning LED located between the FA...

Page 141: ...ate Display the frame number video mode only Display the elapsed time video mode only NOTE The timer display is moveable to any quadrant on the image capture window The timer is available for use outside of FA mode Using Video Controls in FA Mode In FA mode the timer is controlled separately from the video For example when you pause or stop the video video capture is interrupted but the timer cont...

Page 142: ...se Events on page 149 Indications for Use General ophthalmic imaging including retinal corneal and external imaging Photodocumentation of pediatric ocular diseases including retinopathy of prematurity ROP Screening for Type 2 pre threshold retinopathy of prematurity ROP zone 1 stage 1 or 2 without plus disease or zone 2 stage 3 without plus disease or treatment requiring ROP defined as Type 1 ROP ...

Page 143: ...ways start at the lowest light intensity level and increase if necessary Use only the shortest amount of exposure time necessary no greater than 5 minutes per eye Use care when imaging the eye that is the lens tip is immersed in coupling gel and does not contact the eye directly Ensure the camera is supported held in a manner that does not put direct pressure on the cornea Clarity recommends pract...

Page 144: ...For retinal imaging dilate the pupils to at least 6mm Hold the infant s head gently but securely in a face up position Instill ophthalmic coupling gel into the first eye to be imaged or apply a bolus of gel to the camera lens tip Clarity recommends GenTeal Gel which is available in the United States Outside the United States Clarity recommends either Viscotears or Vidisic Using the RetCam When usi...

Page 145: ... RetCam wide field digital retinal imaging by trained neonatal nurses using a standard protocol of three 3 images per eye and the 130 degree lens The infants were 31 to 33 weeks or 35 to 37 weeks postmenstrual age PMA The protocol for this study required that a minimum of three 3 images posterior temporal and nasal photographs be consistently captured for each of the patients Each image set includ...

Page 146: ...equiring ROP are found below Mild ROP was defined as ROP less than Type 2 disease A diagnosis of Unknown meant the grader was uncomfortable making a diagnosis from the data provided Findings were compared with a reference standard of binocular indirect ophthalmoscopy BIO by experienced pediatric ophthalmologists The target conditions referral warranted disease the presence of Type 2 pre threshold ...

Page 147: ... was unable to make a determination for 6 sets of images Eighty three 83 sets of images were concluded by Grader A to have no ROP or mild ROP Based on a review of the RetCam images Grader B concluded that 32 sets of images had Type 2 pre threshold ROP or treatment requiring ROP including all 26 cases determined by BIO to be Type 2 pre threshold ROP or treatment requiring ROP Grader B was unable to...

Page 148: ...sult would result in examination by BIO None of the BIO referrals were missed by the RetCam Graders resulting in 100 sensitivity results for each Grader Due to over referral by two 2 of the Graders and the inclusion of unknowns as referrals specificity results for the graders ranged from 85 to 88 Image Quality Before providing a diagnosis for each image set the three 3 retinal specialist graders a...

Page 149: ...t the training session The newly trained user takes the images using the Clarity practice head and eye first moving on to a patient if available and appropriate New users must demonstrate that they can successfully capture the images as well as perform all data entry processing storage review and export functions attendant to digital documentation systems Comprehensive Training Modules are readily...

Page 150: ... wear gloves The RetCam lens must always be cleaned according to Clarity s instructions before and after each patient Physiological Stress NICU infants are particularly subject to the risk of physiological stress from any procedure One highly effective way to avoid undue stress as a result of a RetCam evaluation is to assure that the user is qualified by education and experience to perform the eva...

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Page 152: ...tle Fuse Replacement on page 160 RetCam Shuttle Illumination Lamp Replacement on page 161 General Support Issues on page 165 Key Validation on page 165 Technical Support on page 167 Technical Support Contact Information on page 167 Service Information on page 167 Unauthorized modifications or additions to the RetCam System including hardware and software etc void the warranty and could adversely a...

Page 153: ...o the concave contact lens area to remove coupling gel and any remaining debris You must wipe the lens piece at least 11 times using a fresh and clean wiping surface for each wipe You can use pre packaged 70 IPA swabs such as ReliOn Alcohol swabs or BD Alcohol Swabs 3 Rinse the lens surface thoroughly using sterile water 4 Air dry the lens 5 Visually verify that the lens surface is free of debris ...

Page 154: ... H8 30 minutes minimum no longer than 2 hours Please refer to the specific FrankLab instruction on double cleaning and disinfection Figure 141 Inverted Lens Piece Showing Permissible Immersion Depth Cleaning the Rest of the System As with any medical device use good public health practices when handling the equipment based on CDC guidelines In addition as with typical office equipment a gentle wip...

Page 155: ...tions that show damage to eliminate the potential for electric shock RetCam 3 Maintenance This section describes the specific recommended process for fuse replacement and illumination lamp replacement for the RetCam 3 system These activities are appropriate under the following conditions Blown fuse Replace system fuses Burned out bulb Replace the illumination bulb RetCam 3 Fuse Replacement Do not ...

Page 156: ...r of the fuse holder at the top of the power entry module See Figure 143 on page 155 Figure 143 Opening the Fuse Holder Cover 2 Remove the fuse holder See Figure 144 on page 155 Figure 144 Removing the Fuse Holder 3 Remove the blown fuse or fuses from the fuse holder and replace it with a new fuse of same type and rating See Figure 145 on page 156 Re insert the fuse holder ...

Page 157: ...amp Replacement Appropriately power down and unplug the unit and allow the illumination lamp to cool before replacing it Replacement illumination lamps are available from Clarity Follow these steps to replace the illumination lamp 1 If it is not already turned OFF turn OFF the instrument according to the instructions found in theTurning OFF the RetCam 3 System section on page 96 2 Disconnect the m...

Page 158: ...being careful not to pull on the cable to remove the focus cable Figure 148 on page 157 5 Turn the camera handpiece connector counterclockwise and remove the camera cable Figure 148 on page 157 Figure 148 Removing the Camera and Focus Cables 6 Remove the two screws from the lamp assembly drawer the smaller panel with the black handle on the front Pull the front cover out Camera Handpiece connector...

Page 159: ...b is fully exposed 8 Just behind the socket and extending from the rear of the illumination lamp is a thick grey lever the lamp ejector shown in Figure 150 on page 158 Be prepared to grab or catch the illumination lamp unit as you gently rotate this lever toward you rotate it up or counterclockwise to eject the lamp Remove the old illumination lamp Figure 150 Removing the Illumination Lamp Lamp as...

Page 160: ...ge 159 replace it in the assembly aligning the two pins in the rear with the corresponding tracks in the socket ensuring the alignment bumps on the lamp is aligned with the notch in the lamp bracket and pushing it gently and evenly into place 10 Check the position of the new bulb to make sure that the reflector of the bulb is located in the center of the lamp socket s opening 11 Push the lamp asse...

Page 161: ...e the illumination bulb RetCam Shuttle Fuse Replacement Do not replace the fuse until the system is completely shut down Locate the power entry module on the lower right side of the rear of the cart Figure 152 on page 160 Make sure to remove the power cord before proceeding any further Figure 152 Power Entry Module To replace the RetCam Shuttle fuse 1 Using a flat blade screwdriver gently pry open...

Page 162: ...e fuse holder Figure 155 Blown Fuse Removed For continued protection against risk of fire replace only with same type and rating fuse Replacement fuses are available from Clarity Technical Services RetCam Shuttle Illumination Lamp Replacement Appropriately shutdown and unplug the unit to allow the bulb to cool before replacing it NOTE Replacement bulbs are available from Clarity Technical Services...

Page 163: ...cable from the front panel 4 Remove the two screws from the lamp assembly drawer Figure 156 Front Panel Showing Lamp Assembly Drawer 5 Grip the handle on the lamp assembly drawer Pull the drawer out slowly Stop when the bulb is fully exposed Figure 157 Open Lamp Assembly Drawer 6 Just behind the socket and extending from the rear of the illumination lamp is a thick grey lever the lamp ejector show...

Page 164: ...exterior surface of the illumination lamp Do not touch the bulb which is located in the center of the reflector nor the inner concave surface of the reflector Skin oils adhere to the bulb and reflector which reduces the cooling efficiency of the bulb and thereby creates a hot spot that leads to premature burnout Handle the outside of the lamp only as shown in Figure 159 on page 164 and Figure 160 ...

Page 165: ...lignment bumps on the lamp is aligned with the notch in the lamp bracket and push it gently and evenly into place Figure 160 Insert New Bulb 10 Check the position of the new bulb to make sure that the reflector of the bulb is located in the center of the lamp socket opening 11 Carefully push the lamp assembly drawer back Use caution to avoid pinching wires in the area 12 Replace the two screws on ...

Page 166: ...rity to use the revamped system and you cannot request this key until after installation is complete Since it can take up to two 2 business days to obtain a license key after submitting a request we recommend that you effect system or software upgrades when you can manage two business days without use of the system NOTE To ensure the preservation of your patient data and images we strongly recomme...

Page 167: ...for your system Be prepared to provide the model and serial number of your RetCam device The Clarity representative then provides you with a unique authorization key NOTE You might also send the license key along with the model and serial number of your RetCam device via email to service retcam com and receive the authorization key by return email You must enter the authorization key in the field ...

Page 168: ...2093 Telephone support is available Monday through Friday from 8 a m to 5 p m Pacific Time If necessary please leave a message Clarity Technical Services returns calls promptly E mail service retcam com Clarity s U S Technical Services responds to e mails promptly Our goal is to respond within 24 hours of receipt Mailing Address Send correspondence to Clarity Medical Systems Inc 5775 West Las Posi...

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Page 170: ...on page 171 RetCam Shuttle Software Requirements on page 171 RetCam Shuttle Environmental Conditions on page 172 RetCam 3 Technical Specifications RetCam 3 Hardware Requirements Physical 26 660 mm wide x 24 610 mm deep x 54 1372 mm minimum height Approximately 200 lbs 91 Kg fully loaded Electrical Ratings 100 240 V 50 60 Hz 700 VA Fuses 3AG 10A 250V slo blo 5 x 20 mm Power consumption 700W maximum...

Page 171: ...ble 15 RetCam 3 Environmental Conditions Condition Operating Storage unboxed Transport in original shipping material Temperature 50º F to 95º F 10º C to 35º C 14º F to 131º F 10º C to 55º C 20º F to 122º F 29º C to 50º C Relative Humidity 30 to 90 non condensing 30 to 90 non condensing 10 to 85 non condensing Atmospheric Pressure 20 7 to 31 3 inches Hg 70 to 106 kPa 20 7 to 31 3 inches Hg 70 to 10...

Page 172: ...rical Ratings 100 240V_ 50 60 Hz 250VA Input Power 100 240 V 50 60 Hz Fuse T 3A 250V Power consumption 250W maximum Detachable hospital grade power cord Notebook Computer Intel Core 2 Duo 4GB Random Access Memory 500 GB hard drive DVD R RW drive 4 USB connections 2 USB available Audio 10 100 Ethernet Adapter Intel 512 MB Video Adapter NOTE Specifications subject to change without notice RetCam Shu...

Page 173: ...ntal Conditions Condition Operating Storage unboxed Transport in original shipping material Temperature 59º F to 95º F 15º C to 35º C 14º F to 131º F 10º C to 55º C 20º F to 122º F 29º C to 50º C Relative Humidity 30 to 90 non condensing 30 to 90 non condensing 10 to 85 non condensing Atmospheric Pressure 20 7 to 31 3 inches Hg 70 to 106 kPa 20 7 to 31 3 inches Hg 70 to 106 kPa 20 7 to 31 3 inches...

Page 174: ...ecifically granted in this statement Any attempt to decompile reverse engineer or otherwise copy this software shall be considered a breach of this agreement Do not install non resident or third party software on the RetCam system RetCam Software End User License Agreement You have acquired a RetCam DEVICE that includes software licensed by Clarity Medical Systems Inc from Microsoft Licensing Inc ...

Page 175: ...systems in which the failure of Java technology could lead directly to death personal injury or severe physical or environmental damage Sun Microsystems Inc has contractually obligated MS to make this disclaimer No Liability for Certain Damages EXCEPT AS PROHIBITED BY LAW MS SHALL HAVE NO LIABILITY FOR ANY INDIRECT SPECIAL CONSEQUENTIAL OR INCIDENTAL DAMAGES ARISING FROM OR IN CONNECTION WITH THE ...

Page 176: ...175 RetCam 3 and RetCam Shuttle User Manual PN 18 000393 Rev A ...

Page 177: ...Medical Systems Inc 5775 W Las Positas Blvd Pleasanton CA 94588 USA Phone 1 925 463 7984 Fax 1 925 251 0078 Toll free 1 800 215 6005 www claritymsi com RetCam 3 and RetCam Shuttle User Manual PN 18 000393 Rev A ...

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