Clarity RetCam 3 User manual

Ophthalmic Imaging System
International
PN 21-100375 Rev. A
For use with
software version 5.1
User Manual
Caution: Federal law (US) restricts this device to sale
by or on the order of a physician or licensed
medical practitioner.

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RetCam3 User Manual PN 21-100375 Rev. A
Copyright
© 2009 Clarity Medical Systems, Inc. All rights reserved.
MediMark® Europe S.A.R.L.
11 rue Emile Zola
38100 GRENOBLE
France
Tel: [phone]
Fax: [phone]
e-mail: [email protected]m

RetCam3 User Manual PN 21-100375 Rev. A
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Contents
1 Introduction....................................................................................7
•Indications for Use.....................................................................................................7
•Warnings and Cautions................................................................................... 7
•Main Hardware Components.....................................................................................9
•Electrical Safety Information ......................................................................... 10
•Important User Safety Notices...................................................................... 13
•Labels and Symbols...................................................................................... 14
•Product Label ..........................................................................................................18
2 Using the RetCam 3....................................................................19
•Turning the System ON (from Stand-by Mode)............................................. 19
•Installing Lens Pieces ................................................................................... 21
•Turning the System OFF (Stand-by Ready).................................................. 21
•Using Hard Shutdown................................................................................... 22
•Turning OFF the Main Power........................................................................ 23
•Managing Patient Records............................................................................ 23
•Add a New Patient Record......................................................................................24
•Editing a Patient Record..........................................................................................24
•Finding Existing Patient Records.............................................................................25
•Performing Exams......................................................................................... 26
•Capturing Still Images..............................................................................................28
•Capturing Video.......................................................................................................29
•Video Playback........................................................................................................30
•Deleting a Video ......................................................................................................30
•Using Helpful Features.................................................................................. 30
•Shortcut Keys ..........................................................................................................30
•Still Images From Video...........................................................................................30
•Changing Image Capture Options During an Exam ................................................32
•Adding Exam Notes ...................................................................................... 33
3 Image Review and Compare Mode.............................................35
•Image Review Screen................................................................................... 35
•Compare Mode ............................................................................................. 37
•Image Adjustment......................................................................................... 39
•Image Adjustment Parameters...............................................................................40
•Annotation................................................................................................................41
4 Import and Export Images...........................................................43
•Backing Up Images....................................................................................... 43
•Exporting Images.......................................................................................... 43
•Select Images for Export.........................................................................................44
•Select Export Options..............................................................................................45
•Select the File Format .............................................................................................45
•Export Image Formats.............................................................................................46
•Export Data Formats................................................................................................46
•Complete Export......................................................................................................47
•Importing Images .......................................................................................... 47

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RetCam3 User Manual PN 21-100375 Rev. A
5 Printing Images............................................................................51
•Printing Images and Reports......................................................................... 51
•Recommended Supplies............................................................................... 52
6 Fluorescein Angiography Module................................................53
•Theory of Operation...................................................................................... 53
•Using Fluorescein Angiography (FA) Module................................................ 53
•Configuring the FA Module Timer............................................................................56
7 Maintenance and Support ...........................................................57
•Recommended Maintenance Schedule........................................................ 57
•Cleaning Procedures .................................................................................... 57
•Cleaning the Lens Piece..........................................................................................57
•Cleaning the Rest of the System.............................................................................59
•Disposal of Materials ...............................................................................................59
•Fuse Replacement........................................................................................ 59
•Replace Illumination Lamp/Bulb................................................................... 61
•Key Validation ............................................................................................... 65
•Technical Support ......................................................................................... 66
•Technical Support Contact Information....................................................................66
•Service Information....................................................................................... 67
8 User Preferences.........................................................................69
•Institution.................................................................................................................71
•New Exam ...............................................................................................................71
•Printers ....................................................................................................................72
•Windows Configuration............................................................................................72
9 Technical Specifications...............................................................73
•Hardware ...................................................................................................... 73
•Physical ...................................................................................................................73
•Electrical..................................................................................................................73
•Environmental Conditions........................................................................................73
10 License Agreements....................................................................75
•CMS Software Restricted Rights................................................................... 75
•RetCam3 Software End User License Agreement........................................ 75
Index............................................................................................77

RetCam3 User Manual PN 21-100375 Rev. A
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List of Figures
Figure 1 RetCam3 Ophthalmic Imaging System front view*................................................... 8
Figure 2 RetCam3 Ophthalmic Imaging System rear view..................................................... 9
Figure 3 Handpiece and Lens piece..................................................................................... 10
Figure 4 Control panel .......................................................................................................... 20
Figure 5 Installing a lens piece on the handpiece................................................................. 20
Figure 6 Handpiece connections .......................................................................................... 21
Figure 7 Shutdown button..................................................................................................... 22
Figure 8 Footswitch pocket................................................................................................... 22
Figure 9 Start screen ............................................................................................................ 23
Figure 10 Add new patient screen.......................................................................................... 24
Figure 11 Edit Patient record screen ...................................................................................... 25
Figure 12 Search buttons ....................................................................................................... 25
Figure 13 Patient search options............................................................................................ 25
Figure 14 Patients and Exams Screen (Patient Directory) ..................................................... 26
Figure 15 Patients and Exams screen navigation buttons...................................................... 26
Figure 16 New Exam configuration screen............................................................................. 27
Figure 17 Show Thumbnails button........................................................................................ 27
Figure 18 New Exam screen .................................................................................................. 28
Figure 19 Onscreen capture controls ..................................................................................... 28
Figure 20 Video and image capture controls.......................................................................... 29
Figure 21 Video thumbnails.................................................................................................... 31
Figure 22 Video scrollbar control............................................................................................ 31
Figure 23 Select options for image capture............................................................................ 32
Figure 24 Enable mouse-over ................................................................................................ 33
Figure 25 Exam Notes dialog ................................................................................................. 33
Figure 26 Image Review screen............................................................................................. 35
Figure 27 Compare [Images] screen ...................................................................................... 38
Figure 28 Select patients and exams for export ..................................................................... 44
Figure 29 Export dialog........................................................................................................... 44
Figure 30 Export destination options ...................................................................................... 45
Figure 31 Select file format..................................................................................................... 45
Figure 32 Select image and data format................................................................................. 46
Figure 33 Export progress dialog............................................................................................ 47
Figure 34 Start screen ............................................................................................................ 48
Figure 35 Import Folder dialog................................................................................................ 48
Figure 36 Import successful.................................................................................................... 50
Figure 37 Print dialog.............................................................................................................. 51
Figure 38 Front panel of FA Module....................................................................................... 53
Figure 39 Barrier filter installation........................................................................................... 54
Figure 40 FA timer controls .................................................................................................... 55

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RetCam3 User Manual PN 21-100375 Rev. A
Figure 41 Inverted lens piece showing permissible depth of immersion................................. 58
Figure 42 Power Entry Module ............................................................................................... 59
Figure 43 Opening the fuse holder cover ............................................................................... 59
Figure 44 Removing the fuse holder....................................................................................... 60
Figure 45 Fuses removed....................................................................................................... 60
Figure 46 Fuse holder re-inserted .......................................................................................... 61
Figure 47 Front panel showing the lamp assembly drawer .................................................... 62
Figure 48 Open the drawer..................................................................................................... 62
Figure 49 Removing the bulb.................................................................................................. 63
Figure 50 Catch the bulb ........................................................................................................ 63
Figure 51 Place new bulb in socket........................................................................................ 64
Figure 52 Close drawer and replace connections .................................................................. 65
Figure 53 Key Validation dialog.............................................................................................. 66
Figure 54 Access User Preferences....................................................................................... 69
Figure 55 About Clarity software ............................................................................................ 69
Figure 56 User Preferences screen........................................................................................ 70
Figure 57 User Preferences: Institution .................................................................................. 71
Figure 58 User Preferences: New Exam ................................................................................ 71
Figure 59 User Preferences: Printers ..................................................................................... 72
Figure 60 User Preferences: Windows Configuration............................................................. 72

RetCam3 User Manual PN 21-100375 Rev. A
Introduction 7
1 Introduction
The RetCam3 Ophthalmic Imaging System (system) is designed to allow the
quick and easy capture of wide field, high resolution, fully digital images and videos
of the eye.
Indications for Use
For general ophthalmic imaging, including retinal, corneal, and external.
Warnings and Cautions
CAUTION: Federal law (US) restricts this device to sale by or on the order of a
physician or licensed medical practitioner.
WARNING: Prior to using the system, read all user safety information.
WARNING: Before using this equipment to acquire images from patient eyes, users
must be trained in proper clinical technique by personnel authorized by Clarity.
WARNING: The RetCam system is designed and tested as a system. Omission or
substitution of RetCam components may adversely affect system performance and
is strongly not recommended.
WARNING: Unauthorized modifications or additions to the RetCam system
(including hardware and software, etc.) could adversely affect system function and
will void the warranty.
WARNING: Carefully inspect and clean the lens piece before each use. DO NOT
USE if the lens piece has nicks, breaks, scratches, or rough surfaces that may
damage the eye.
WARNING: To mitigate the potential for excess light exposure, always 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.
WARNING: Use care when contacting the eye; i.e., use the least amount of
pressure and/or movement necessary.
WARNING: A risk/benefit ratio must be assessed before confirming a patient for
RetCam imaging if they are: photosensitive, concomitantly exposed to
photosensitizing agents, or aphakic.
WARNING: To avoid the risk of electric shock, the equipment must be connected to
a supply mains with protective earth.
WARNING: To mitigate the potential for excess light exposure, the user should
avoid looking directly at the illuminated light source.

8 Introduction
RetCam3 User Manual PN 21-100375 Rev. A
Figure 1 RetCam3 Ophthalmic Imaging System front view*
*Shown with optional FA (Fluorescein Angiography) feature
Display
Handpiece with
Interchangeable
Holster
Handpiece Cable
FA Light Connector
Storage
Drawers
Footswitch
DVD writer
(inside drawer)
Control
Panel
Lockable
Front 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 ports)

RetCam3 User Manual PN 21-100375 Rev. A
Introduction 9
Figure 2 RetCam3 Ophthalmic Imaging System rear view
Main Hardware Components
•Display: A flat panel display is standard with the system.
•Control Panel: A membrane control panel turns the system on with one button,
and has controls for illumination intensity, camera focus and snap (capture an
image or start/stop video recording).
•Handpiece: Contains the camera. Lightweight and easy to position, it has a
long cable for easy reach. Use with changeable lens pieces.
Ethernet Port
Product Label
Main Power Switch and
Power Cord Connection

10 Introduction
RetCam3 User Manual PN 21-100375 Rev. A
•Chassis: Contains the control systems and connections.
•Footswitch: Provides optional means to control illumination intensity, camera
focus and snap.
•Storage Drawers: All units have two storage drawers for lens pieces, tools and
supplies.
•Fluorescein Angiography Module or FA (optional): An optional blue exciter
light source is available for FA digital photography. It comes complete with a
yellow barrier filter for the handpiece. You can adjust illumination intensity only
through the FA intensity control.
•Printer: Color images and reports can be printed.
Figure 3 Handpiece and Lens piece
Electrical Safety Information
The system has been designed, inspected and tested to comply with the safety
requirements of IEC60601-1 with respect to fire, shock and mechanical hazards
only if used as intended.
Class IType BF Electrical Equipment
Rated for Continuous Operation
Handpiece
Lens piece
Lens Model Application Common Field of View
D1300 Premature Infant 130 Degrees
B1200 Standard Baby 120 Degrees
E800 High Contrast Children’s & Adults 80 Degrees
C300 High Magnification 30 Degrees
PL200 Portrait Lens N/A