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
3
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
5
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

RetCam3 User Manual PN 21-100375 Rev. A
Introduction 11
Electromagnetic Emissions
Compliance Level: Group 1, Class A
Test Type Compliance Level Notes
Conducted Emissions
CISPR 11/
EN 55011
Class A The RetCam system uses RF energy for its internal
function. Nearby electronic equipment may be
affected.
Radiated Emissions
CISPR 11/
EN 55011
Class A
Harmonic emissions
IEC 61000-3-2 Complies
Voltage fluctuations/flicker emissions
IEC 61000-3-3 Complies
FCC Part 15B Complies

12 Introduction
RetCam3 User Manual PN 21-100375 Rev. A
Electromagnetic Immunity
Test Type IEC 60601-1-2 test and
compliance level Electromagnetic Environment Guidance
Electrostatic Discharge (ESD)
EN 61000-4-2 ±6 kV contact
±8 kV air Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Electrical Fast Transients
(AC Power)
(I/O Lines)
EN 61000-4-4
±2 kV for power supply lines Mains power quality should be that of a typical
commercial or hospital environment. AC Power
electronic disturbances (transients) may cause
the system's display to scroll continuously. If
this occurs, imaging should not processed until
the disturbance has ceased.
Surge Line to Line
(AC Power)
(I/O Lines)
EN 61000-4-5
±1 kV line(s) to line(s)
±2 kV line(s) to earth Mains power quality should be that of a typical
commercial or hospital environment.

Voltage dips and interruptions
EN 61000-4-11
>95% dip in Ut 0.5 cycle 
60% dip in Ut 5 cycles 
30% dip in Ut 25 cycles
>95% dip in Ut 5 seconds
If the user of the RetCam system requires
continued operation during power mains
interruptions, it is recommended that the
RetCam system be powered from an
uninterruptible power supply or a battery.
Power Frequency (50/60 Hz)
magnetic field
EN 61000-4-8
3 A/m Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Radiated Immunity
EN 61000-4-3 80MHz-2.5GHz 3V/m 80%@1kHz Portable and mobile RF communications
equipment should be used no closer to any
part of the RetCam system, including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
d = 3.5 / E180 MHz to 800 MHz
d = 7 / E1800 MHz to 2.5 GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters
(m). E1is 3 V/m.
Conducted Immunity:
d= (3.5/ V1)where V1is 3 Vrms.
Field strength from fixed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in
each frequency range. Interference may occur
in the vicinity of equipment marked with the
following symbol.
Conducted Immunity
EN 61000-4-6
0.15-80MHz
3 Vrms 80%@1kHz
AC Mains
P
P
P

RetCam3 User Manual PN 21-100375 Rev. A
Introduction 13
WARNING: Interference may occur in the vicinity of
equipment marked with the following symbol.
This equipment/system may cause radio interference or may disrupt the operation
of nearby equipment. It may be necessary to take mitigation measures such as:
• Reorient or relocate the receiving device
• Increase the separation between the equipment
• 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 power the
system back on.
WARNING: This equipment may cause radio interference or may disrupt the
operation of nearby equipment. It may be necessary to take mitigation measures,
such as reorienting or relocating the system or shielding the location.
WARNING: To avoid the risk of electric shock, this equipment must be connected to
a supply mains with protective earth.
WARNING: For continued protection against risk of fire, replace only with same
type and rating fuse.
Important User Safety Notices
1. Never contact the front of the lens piece with hard or sharp objects. This could
damage the precision optics and sealing.
2. DO NOT AUTOCLAVE any part of the device.
3. Appropriately power down and unplug the unit and allow the light source bulb to
cool before replacing it.
4. Always return the handpiece to the holster when not imaging. You can drape the
handpiece cable over the cord wrap post, but do not wrap it tightly or damage to
the fiber optic may result.
5. Do not block access to the holster.
6. The system is not intended to be transported outdoors.
7. Newly acquired data may be lost if power is interrupted during live imaging.
+Note: backup battery power is available for at least 15 minutes after interrupt.

14 Introduction
RetCam3 User Manual PN 21-100375 Rev. A
8. The system comes protected from viruses, worms, and spyware with
Microsoft’s anti-malware. Please refer to your warranty prior to adding any
additional software or contact Clarity Service.
Labels and Symbols

System Power button

Focus

Focus Controls

Lamp Illumination button

Intensity Controls

SNAP (capture) switch or button

Warning or Caution
Warning:
Do not look directly into light source
Warning: Dangerous Voltage
(used in FA)

Chassis ground

RetCam3 User Manual PN 21-100375 Rev. A
Introduction 15

Protective earth (ground)

Alternating current (AC)
System contains 2 fuses of indicated type. 
Do not use any other type.

Backup battery

Computer network

Non-ionizing electromagnetic radiation

FA = Fluorescein Angiography

FA light Intensity, increase clockwise

FA light OFF

FA light ON

Light source (fiber optic) connector

Handpiece connector

16 Introduction
RetCam3 User Manual PN 21-100375 Rev. A

USB connector

Read accompanying user documentation

Fragile contents


This side of carton up


Temperature limits


Authorized representative in the EU

Type BF equipment (applied 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

RetCam3 User Manual PN 21-100375 Rev. A
Introduction 17

North American compliance certification

Serial number

Date of Manufacture
Keep away from the rain
Go to next screen
Hide image
Delete image
Flag or select item
Reset
View patient directory
Utilities

18 Introduction
RetCam3 User Manual PN 21-100375 Rev. A
Product Label

RetCam3 User Manual PN 21-100375 Rev. A
Using the RetCam 3 19
2 Using the RetCam 3
This chapter explains how to use the RetCam 3 system, after it is properly installed
at your site. The activities described include:
•Turning the System ON (from Stand-by Mode) on page 19
•Turning the System OFF (Stand-by Ready) on page 21
•Using Hard Shutdown on page 22
•Turning OFF the Main Power on page 23
•Managing Patient Records on page 23
•Performing Exams on page 26
•Using Helpful Features on page 30
•Adding Exam Notes on page 33
Turning the System ON (from Stand-by Mode)
+New systems are installed by Clarity trained personnel. The installation
includes installing main power, attaching the handpiece, and adjusting the
monitor. Upon request, full installation instructions are available from the
Clarity Service Department. The instructions in this chapter are for using an
installed system, which has the main power, printer, and monitor turned ON,
the monitor height adjusted, and software installed and configured for the
site.
+Note: After software is installed, the system requires an Authorization key to
initiate the system. The key is available through Clarity MSI service.
CAUTION: Never block any RetCam 3 System vents.
CAUTION: Never block access to the handpiece holster.
To turn the system ON from the Stand-by mode:
1. Carefully pull out the input shelf until it is fully extended.
2. Depress the System Power (Stand-by) button (located on the Control Panel) to
turn ON system power. The System Power (Stand-by) indicator light (solid
green) should be illuminated. The software should initialize.

20 Using the RetCam 3
RetCam3 User Manual PN 21-100375 Rev. A
The membrane control panel is located at the front edge of the keyboard tray. It
provides controls and indicators of system status.
Figure 4 Control panel
3. Attach the desired lens piece to the Handpiece, as shown in Figure 5 and
Installing Lens Pieces on page 21.
Figure 5 Installing a lens piece on the handpiece
Illumination ON
Lamp Illumination
System Power
System power
Stand-by button
Relative intensity
indicator
Intensity Controls
Focus Controls
AC/DC
indicator
SNAP
button
(capture)
(green) indicator (amber)
indicator
(green) Focus
ON/OFF button
alignment pins
on handpiece
Align lens piece
to fit over pins
Carefully tighten clockwise
until it clicks in place. Do
not overtorque.