Clarity RetCam3 User manual

QS Form QF-42-01f
COMPONENT SPECIFICATION
Issued by: QA Date: 07/01/13 Rev. C ECO-4242 Pg. 1of 1
THIS DOCUMENT AND THE DATA CONTAINED HEREWITH IS THE PROPRIETARY PROPERTY OF CLARITY MEDICAL SYSTEMS, INC AND IS NOT TO BE REPRODUCED,
USED, OR DISCLOSED IN WHOLE OR PART TO ANYONE WITHOUT THE WRITTEN PERMISSION OF CLARITY MEDICAL SYSTEMS, INC.
Uncontrolled Copy unless stamped “CONTROLLED COPY” in red.
Originator: P. Thompson Date: 8/15/2013
Clarity Part Number:
18-000393 Part Description:
UM, V6.3, RC3/RCS Rev
A
Purchased off the Shelf, Without Modifications Custom Part Per Clarity Spec. (Control Drawing Req.)
Manufacturer: Clarity P/N: 18-000393 REV A
Supplier: P/N:
Supplier: P/N:
Supplier: P/N:
Alternate Manufacturer (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 standard unit of measure): $0.00
Purchase Unit of Measure: Each Inch Foot Millimeter Meter Ounce Pack Roll Box
Bottle Tube Other: _ Qty/Per: _
Special Packaging and/or Marking: Yes No If Yes, specify: _
Special Handling: Yes No If Yes, specify: _
Notes:
1. Electronic (PDF) version to be copied onto a CD per 800175.
2. Source file format is FrameMaker v8.0.
3.
See Attachments:
1. Manual text from PDF file; 176 pages including back page.
2.
3.
Rev Component Revision History Date ECO
A Initial Release 8/22/2013 4281

*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

2
RetCam 3 and RetCam Shuttle User Manual PN 18-000393 Rev. A
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: [phone]
Fax: [phone]
e-mail: [e-mail]

RetCam 3 and RetCam Shuttle User Manual PN 18-000393 Rev. A
Contents
List of Tables................................................................................................................9
List of Figures............................................................................................................ 11
1 Introduction................................................................................................................15
Indications for Use ......................................................................................................15
Contraindications ........................................................................................................16
Warnings and Cautions...............................................................................................16
RetCam 3 System Hardware ......................................................................................18
Main Hardware Components.......................................................................................21
The Computer Electro-Optical Box (CEO).............................................................21
Storage...................................................................................................................24
Transport................................................................................................................24
To relocate the system within a building: ..........................................................24
Electrical Safety Information .......................................................................................25
System Hardware (RetCam Shuttle)...........................................................................29
Hardware Components..........................................................................................30
The Electro-Optical Box (EO Box) .........................................................................31
Storage...................................................................................................................33
Transport................................................................................................................33
To relocate the system within a building: ..........................................................33
To transport 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 Software.................................................47
Creating Domains ..................................................................................................47
Creating Domains Without RetCam Review Software......................................48
Creating User Login Accounts ...............................................................................50
Assigning Patients to Domains ..............................................................................51
3 Synchronization with RetCam Review Software (RCRS).........................55
Determining if RetCam is Configured for RCRS .........................................................55
Synchronization with RCRS........................................................................................56
Reconciling Data Mismatches.....................................................................................58
Removing Videos and Images from the RetCam System...........................................60

4
RetCam 3 and RetCam Shuttle User Manual PN 18-000393 Rev. A
4 Preparing the System for Use.............................................................................63
Preparing the RetCam 3 System for Use....................................................................64
Turning the System ON..........................................................................................64
Installing Lens Pieces ............................................................................................65
Handpiece Connection...........................................................................................65
Printer Setup..........................................................................................................66
System Software....................................................................................................66
Fluorescein Angiography .......................................................................................67
Illumination Lamp...................................................................................................67
Preparing the RetCam Shuttle System for Use...........................................................68
Turning the System ON..........................................................................................68
Power Cord and Power Connector...................................................................68
Installing Lens Pieces ............................................................................................71
System Software....................................................................................................72
5 Using the RetCam System....................................................................................73
Managing Patient Records..........................................................................................73
Command Button Colors...................................................................................75
Add a New Patient Record.....................................................................................75
Editing a Patient Record ........................................................................................76
Finding 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
Changing Image Type............................................................................................92
Changing Lens.......................................................................................................92
Adding Exam Notes ....................................................................................................92
Adding Exam Notes During an Exam ....................................................................93
Adding Exam Notes After an Exam........................................................................94
Turning OFF the RetCam 3 System............................................................................96
Using Hard Shutdown............................................................................................98
Turning OFF the RetCam Shuttle System...................................................................98
Using Hard Shutdown............................................................................................98
6 Review and Compare Images..............................................................................99
Exam Review Screen..................................................................................................99
Configure Options...........................................................................................101
Flag Image......................................................................................................102
Full Screen......................................................................................................102
Normal Screen................................................................................................102
Hide Thumbnails.............................................................................................102

5
RetCam 3 and RetCam Shuttle User Manual PN 18-000393 Rev. A
Show Thumbnails ...........................................................................................102
Print Image .....................................................................................................102
Edit Image.......................................................................................................102
Compare.........................................................................................................103
Exam Notes ....................................................................................................103
Exit Review.....................................................................................................103
Compare Mode..........................................................................................................103
Configure ........................................................................................................104
Print Image .....................................................................................................104
Edit Image.......................................................................................................105
End Compare..................................................................................................105
Exit Review.....................................................................................................105
Image Adjustment .....................................................................................................105
Image Display Color Adjustments........................................................................106
Annotating an Image............................................................................................106
Adding Text Notes to an Image............................................................................108
Additional Options................................................................................................108
Reset Button...................................................................................................109
Save As... Button............................................................................................109
7 Import and Export Images...................................................................................111
Backing Up Images....................................................................................................111
Backup Recommendation: Network or Removable USB Storage Device ............111
Compatible Removable Media........................................................................ 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 Reports.....................................................................................123
Recommended Supplies...........................................................................................124
Locations Within the United States ......................................................................124
Locations Outside the United States....................................................................124
9 User Preferences....................................................................................................125
About RetCam Software............................................................................................125
User Preferences......................................................................................................126
Device Identification.............................................................................................127
Domain Configuration ..........................................................................................128
Image Audit..........................................................................................................128
Imaging Adjustment .............................................................................................129
Configuring Live Imaging .....................................................................................129
Configuring New Exam Defaults..........................................................................130
Configuring Notification Options ..........................................................................131

6
RetCam 3 and RetCam Shuttle User Manual PN 18-000393 Rev. A
Configuring Printers .............................................................................................131
Enabling Synchronization ....................................................................................132
Configuring Windows® Preferences....................................................................132
10 Fluorescein Angiography (RetCam 3 System)...........................................135
Theory of Operation ..................................................................................................135
Using Fluorescein Angiography (FA) Mode ..............................................................135
Using Video Controls in FA Mode........................................................................140
11 Screening for Retinopathy of Prematurity (ROP)......................................141
RetCam Physician Information..................................................................................141
Indications for Use ...............................................................................................141
Contraindications .................................................................................................142
Warnings.........................................................................................................142
Preparation...........................................................................................................143
Using the RetCam...........................................................................................143
Screening for Retinopathy of Prematurity .................................................................144
Performance Data.....................................................................................................146
Image Quality............................................................................................................147
Reference..................................................................................................................148
Training .....................................................................................................................148
Photo Documentation................................................................................................148
Adverse Events.........................................................................................................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 Maintenance ...................................................................................160
RetCam Shuttle Fuse Replacement ....................................................................160
RetCam Shuttle Illumination Lamp Replacement ................................................161
General Support Issues ............................................................................................165
Key Validation ......................................................................................................165
Technical Support......................................................................................................167
Technical Support Contact Information................................................................167
Telephone .......................................................................................................167
E-mail..............................................................................................................167
Mailing Address ..............................................................................................167
Service Information..............................................................................................167
13 Technical Specifications .....................................................................................169
RetCam 3 Technical Specifications...........................................................................169
RetCam 3 Hardware Requirements.....................................................................169
Physical ..........................................................................................................169
Electrical .........................................................................................................169
Computer (CEO Module)................................................................................169

7
RetCam 3 and RetCam Shuttle User Manual PN 18-000393 Rev. A
RetCam 3 Software Requirements ......................................................................170
RetCam 3 Environmental Conditions...................................................................170
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

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

RetCam 3 and RetCam Shuttle User Manual PN 18-000393 Rev. A
List of Tables
Table 1 RetCam 3 Electromagnetic Emissions................................................................ 26
Table 2 RetCam 3 Electromagnetic Immunity.................................................................. 27
Table 3 RetCam Shuttle Electromagnetic Emissions....................................................... 36
Table 4 RetCam Shuttle Electromagnetic Immunity ........................................................ 37
Table 5 Patients and Exams Screen Command Buttons................................................. 74
Table 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 Recommended Mitigation Steps.......................................... 149
Table 15 RetCam 3 Environmental Conditions................................................................ 170
Table 16 RetCam Shuttle Environmental Conditions....................................................... 172