Digital Retinal Camera
Operation Manual
Make sure you read this manual before using the instrument.
Keep this manual in a safe place so that you can use it in the future.
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Contents
1 Introduction................................................................................................. 4
Features...................................................................................................... 4
Indications for Use ..................................................................................... 4
Checking Included Items ........................................................................... 5
Conventions Used in This Manual ............................................................ 6
2 Safety ........................................................................................................... 7
Regulatory Information............................................................................... 7
Safety Precautions..................................................................................... 9
Notes on Using CR-2 ............................................................................... 13
Rating Label Display ................................................................................ 16
3 Names of Parts ......................................................................................... 17
Retinal Camera ........................................................................................ 17
Operation Panel ....................................................................................... 19
Observation Monitor ................................................................................ 20
4 Basic Operations...................................................................................... 21
Flow of Operation .................................................................................... 21
Connecting Cables .................................................................................. 22
Preparing for an Examination................................................................... 22
Patient Setup............................................................................................ 24
Alignment ................................................................................................ 25
Photography............................................................................................. 28
Finishing an Examination ........................................................................ 29
5 Photography Auxiliary Functions ...........................................................30
x2 Photography........................................................................................ 30
Small Pupil Photography Function........................................................... 30
Diopter Compensation............................................................................. 31
Anterior Segment Photography ............................................................... 32
External Monitor....................................................................................... 32
6 Maintenance..............................................................................................34
Daily Inspections ..................................................................................... 34
Cleaning the Objective Lens ................................................................... 35
Cleaning the Image Sensor ..................................................................... 36
Cleaning the Outside of the CR-2 ........................................................... 36
Disinfecting the Forehead Rest................................................................ 37
Refilling Chin Rest Paper ......................................................................... 37
Attaching and Removing the Digital Camera .......................................... 37
7 Troubleshooting........................................................................................40
Appendix....................................................................................................... 42
Specifications .......................................................................................... 42
EMC (Electromagnetic Compatibility)...................................................... 43
Warranty and Repair Service .................................................................. 48
3
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Introduction
1
Features
The Canon Digital Retinal Camera CR-2 takes digital photographic retinal images of patient’s eyes
across an angle of view of 45 degrees, in a naturally dilated state without using mydriatics. The CR-2
has the following features:
Reduced flash intensity
The CR-2 can take images at ISO 800/1600 at the standard flash intensity, and ISO 3200/6400 in low
flash intensity mode. This reduces patient discomfort caused by light glare.
Compact, user-friendly design
The CR-2 is designed to be even smaller, more lightweight and compact than the previous model.
This makes it easier to assist patients and provides significant ease of operation.
An operation lever has the integrated functions: vertical movement of the main unit, switching
between anterior segment and fundus, and manual focusing. This lever significantly improves
alignment operability.
Special digital camera
The CR-2 is equipped with a special digital camera using EOS digital technology. This enables the
CR-2 to fully maximize Canon technology for shooting high-quality, high-resolution diagnostic images.
Small pupil photography function
The CR-2 captures retinal images through pupils of the normal diameters from 4.0 mm. This small
pupil photography function permits image to be captured through pupils from 3.3 mm in diameters.
System optimized for digital photography
With the supplied imaging control software, the photographed images can be browsed, processed,
stored, output to the DICOM storage server, exported in DICOM or JPEG format and output to a
printer.
In this manual, the operation procedure is described with the Retinal imaging control software NM 2
(referred to as “Rics NM 2” ).
Indications for Use
For USA
The device is intended to be used for taking digital images of the retina of the human eye without a
mydriatic.
For European Union
This medical device is intended to observe and record images of retinal fundus through the pupil
without making contact with subject’s eye for the purpose of diagnosis by way of producing fundus
image information.
4
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1 Introduction
Checking Included Items
Digital Retinal Camera CR-2
Digital camera cover
Protects the cable that is
connected to the digital
camera.
Main unit
Digital camera
Chin rest paper
Digital camera specialized for
the CR-2.
100 sheets provided.
Power cord
Objective lens cap
Initially covers the objective
lens.
Connects the CR-2 to an AC
outlet. (3 m)
USA and Canada only:
Plug type: VM0275 Hospital-
Grade
Camera mount cap
Body cap
Initially covers the camera
mount on the retinal camera.
Initially covers the mount on
the digital camera.
Dust cover
Use it to cover the CR-2 when
it's not being used.
Operation Manual for the CR-2—this document
Describes the handling precautions and operating instructions for the CR-2.
CD-ROM—Retinal imaging control software NM 2
Contains the Retinal imaging control software NM 2 (Rics NM 2), which is used to record, view and
store photographed images taken with the CR-2.
Operation Manual for the Retinal imaging control software NM 2
Describes the procedures for operating the Rics NM 2.
DICOM Conformance Statement
DICOM Conformance Statement for the Rics NM 2.
Warranty Card (for USA model only)
WEEE Directive Leaflet (for EU model only)
Installation Report
Optional products
External eye fixation lamp
Chin rest paper—500 sheets
5
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1 Introduction
Conventions Used in This Manual
Symbols to indicate safety precautions
This manual uses the following symbols to indicate safety precautions that are important for using the
CR-2 safely. Always follow the advice in these safety precautions.
A warning that incorrect operation may result in death or serious injury.
WARNING
A caution that incorrect operation may result in serious injury.
CAUTION
CAUTION
A caution that incorrect operation may break the CR-2 or damage other
devices.
This symbol indicates actions that must not be taken (prohibited actions).
This symbol indicates actions that must be taken.
This symbol indicates important advice that we strongly recommend be
followed while operating the CR-2.
This symbol indicates supplementary explanations or advice for operating the
CR-2.
References
This manual uses the following style to indicate reference destination.
Example: (see page 15)
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Safety
2
Regulatory Information
The following sections list the classifications applicable to the CR-2 and the directives and standards
that the CR-2 complies with.
Device Classification
Protection against electric shock
Class I equipment
Type B applied parts
IPX0
Degree of protection against electric shock
Degree of protection against ingress of water
Degree of safety of application in the presence of a
flammable anaesthetic mixture with air or with oxygen or
nitrous oxide
Not suitable
Mode of operation
Continuous operation
Directives and Standards
USA and Canada
UL 60601-1
Medical electrical equipment – Part 1: General
requirements for safety
CAN/CSA C22.2 No.601.1
IEC 60601-1: 1988+A1: 1991+A2: 1995
IEC 60601-1: 2005
IEC 60601-1-1: 2000
Medical electrical equipment – Part 1-1: General
requirements for safety – Collateral standard: Safety
requirements for medical electrical systems
IEC60601-1-2: 2001+A1: 2004
Medical electrical equipment – Part 1-2: Collateral
standard: Electromagnetic compatibility – Requirements
and tests
IEC 60601-1-4: 1996+A1: 1999
ISO 15004-1: 2006
Medical electrical equipment – Part 1-4: Collateral
standard: Programmable electrical medical systems
Ophthalmic instruments – Part 1: General requirements
applicable to all ophthalmic instruments
ISO 15004-2: 2007
Ophthalmic instruments – Part 2: Light hazard protection
ISO 10993-1: 2009
ISO 10993-5: 2009
ISO 10993-10: 2009
Biological evaluation of medical devices – Evaluation and
testing
7
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2 Safety
European Union
93/42/EEC
Medical Device Directive
EN 60601-1: 1990+A1: 1993+A2: 1995
EN 60601-1: 2006
Medical electrical equipment – Part 1: General
requirements for safety
IEC 60601-1-1: 2001
Medical electrical equipment – Part 1-1: General
requirements for safety – Collateral standard: Safety
requirements for medical electrical systems
EN 60601-1-2: 2007
Medical electrical equipment – Part 1-2: Collateral
standard: Electromagnetic compatibility – Requirements
and tests
IEC60601-1-4: 1996+A1: 1999
EN 60601-1-6: 2004
Medical electrical equipment – Part 1-4: General
requirements for safety – Collateral standard:
Programmable electrical medical systems
Medical electrical equipment – Part 1-6: General
requirements for safety – Collateral standard: Usability
IEC 62304: 2006
EN 62366: 2008
Medical device software – Software life-cycle processes
Medical device – Application of usability engineering to
medical devices
EN ISO 14971: 2009
EN ISO 15004-1: 2009
ISO 15004-2: 2007
Medical device – Application of risk management to
medical devices
Ophthalmic instruments – Part 1: General requirements
applicable to all ophthalmic instruments
Ophthalmic instruments – Part 2: Light hazard protection
EN ISO 10993-1: 2009
EN ISO 10993-5: 2009
EN ISO 10993-10: 2009
Biological evaluation of medical devices – Evaluation and
testing
Deutschland
Während des Betriebs liegt der Schalldruckpegel dieses Instruments bei 70 dB(A) oder weniger
gemäß EN ISO 7779.
8
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2 Safety
Safety Precautions
To prevent injuries and data loss, operate the CR-2 correctly by following the safety precautions.
To avoid the risk of electric shock, this equipment must only
be connected to a supply mains with protective earth.
WARNING
Do not damage the power cord.
• Do not place anything heavy onto the power cord.
Prohibited
• Do not damage or modify the power cord.
• Do not forcibly bend, twist or pull the power cord.
• Do not hold the power cord when removing it from the AC outlet. Be sure to hold
the plug.
Handle the power cord carefully. If the cord is damaged, contact your sales
representative or local Canon dealer. A damaged cord may result in fire or electric
shock.
Do not use a multiple power strip and an extension cable.
Connect the power cord directly to the AC outlet. Do not use a multiple power strip
and an extension cable with it.
Prohibited
Prohibited
Do not disassemble or modify.
A disassembled or modified instrument may result in fire or electric shock. Because
the CR-2 incorporates high-voltage parts that may cause electric shocks, touching
them may cause death or serious injury.
Do not leave alcohol, thinner, or any flammable chemicals
near the instrument.
Do not place the CR-2 near a flammable solvent. Fire may result if the solvent spills
or evaporates and makes contact with the internal electric parts. Some disinfectants
are flammable. Be sure to take precautions when using them.
Prohibited
Stop using immediately if there is an abnormality or problem.
If an abnormality occurs, immediately turn off the power and
disconnect the plugs on all devices.
• Smoke is emitted
• An unusual smell
• An unusual noise
• Foreign matter gets inside
• Devices are damaged.
Fire or electric shock may result if you continue using in such conditions.
Immediately turn off the power of CR-2, unplug the power plug and turn off the
power of all connected devices. Then, contact your sales representative or local
Canon dealer immediately.
Do not place anything on top of the device.
Fire or electric shock may result if water or any other liquid or a needle, paper clip or
any foreign matter gets inside the CR-2.
Prohibited
9
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2 Safety
Do not use a power supply voltage other than that specified
on the rating label.
WARNING
Prohibited
Do not use any power cord other than the one supplied.
Use the power voltage specified on the rating label. Otherwise, fire or electric shock
may result.
The supplied power cord is designed exclusively for this product. Do not use any
other power cord.
Do not plug or unplug the power plug with wet hands.
Do not plug or unplug the power plug or handle any other parts with wet hands.
Otherwise, fire or electric shock may result.
Prohibited
Unplug the plug periodically and remove any dust or dirt
around the plug and the AC outlet.
If the cord is kept plugged in for a long time in a dusty, humid or sooty environment,
dust around the plug will attract moisture, resulting in possible insulation failure that
may result in a fire.
Insert the power plug completely.
Insert the power plug completely into the AC outlet. If a pin of the power plug makes
contact with metal or any conductive object, fire or electric shock may result.
Do not clean the CR-2 with flammable solvent.
For safety reasons, before cleaning the CR-2, be sure to turn off the power of all the
devices and unplug the power cord from the AC outlet. Do not use alcohol, benzine,
thinner or any other flammable solvent.
Prohibited
Otherwise, fire or electric shock may result.
Turn off the power before inspection.
For safety reasons, before inspecting the instrument or cables, be sure to turn off
the power of all the devices.
Otherwise, electric shock may result.
Do not play the supplied CD-ROM in any CD player that does
not support data CD-ROMs.
Playing the CD-ROM in an audio CD player may damage the speaker. Playing the
CD-ROM in an audio CD player may also cause hearing loss if listened to with
headphones.
Prohibited
Be sure to turn off the power before moving the CR-2.
Before moving the CR-2, make sure that the power is turned off, the power
plug is removed from the AC outlet, and any cables that are connected to other
devices are disconnected.
Do not touch conductive parts of non-medical equipment and
the patient simultaneously.
Otherwise, electric shock may result.
Prohibited
Use an isolation transformer when this system is connected
to a network.
Connect an isolation transformer conforming to IEC 60601-1 for networks between
the computer and HUB.
Otherwise, there is a risk of electric shock if the network is faulty.
10
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2 Safety
Do not install in locations exposed to water, steam, moisture
or dust.
CAUTION
Prohibited
Prohibited
Prohibited
Doing so may cause problems or malfunctions.
Do not install in locations exposed to salt, sulfur or corrosive
gas.
Doing so may result in corrosion of the instrument, problems or malfunctions.
Do not install in locations that are unstable or exposed to
vibration.
The vibration may knock over the instrument or the instrument may become
unbalanced and fall, resulting in a malfunction or injury.
Do not place anything near the power plug.
To make it easy to unplug the power plug at any time, avoid putting any obstructions
near the AC outlet.
Prohibited
Fire or electric shock may result if the power plug is not unplugged during an
emergency.
Do not block the vent holes.
Doing so may cause the internal temperature to rise and result in fire.
Prohibited
Prohibited
Do not place your hands or fingers on the base.
Your hand or fingers may be pinched and injured when the stage moves to either
side.
Similarly, instruct the patient not to place his/her hands or fingers on the base.
Do not hold the head rest or digital camera when moving the
CR-2.
When carrying the CR-2, be sure to tighten the stage lock, hold the carrying
indentations at the front and rear of the base panel, and keep the CR-2 level. Do not
hold it by the digital camera or the head rest or any other parts, as they may come
off and result in injury.
Prohibited
Hold the CR-2 when connecting or disconnecting a cable.
For safety reasons, when connecting or disconnecting the power cord or any cable,
be sure to hold the main unit. Otherwise, the main unit may fall over, possibly
causing injury.
Ensure that the entire system conforms to IEC 60601-1-1.
Use the computer, monitor, and other equipment that conform to the system
standard IEC 60601-1 or IEC 60950-1 for the Digital Retinal Camera CR-2. Be sure
that the entire system conforms to IEC 60601-1-1. Be sure to also use an isolation
transformer conforming to IEC 60601-1 when a computer or monitor conforming to
IEC 60950-1 is used.
Otherwise, electric shock may occur. For details, please contact your sales
representative or local Canon dealer.
11
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2 Safety
Keep the forehead rest and chin rest clean.
To prevent the risk of infection, wipe the forehead rest with disinfectant ethanol for
each patient. To ensure cleanliness, replace the chin rest paper for each patient.
If the chin rest paper is not being used, be sure to disinfect the chin rest for each
patient.
CAUTION
For details on how to disinfect, consult a specialist. The forehead rest may be
corroded if a disinfectant other than those above is used.
Slowly move the main unit towards the patient’s eye when
taking an image.
When adjusting the position of the main unit in the front-back direction, slowly bring
the main unit closer to the patient while looking at the patient’s eye from the side.
The patient’s eye may be injured if the objective lens makes contact with it.
Check the image before using the CR-2.
Before using the CR-2, be sure to take a test image to ensure that there is no foreign
matter present that can affect image readings or diagnosis.
Be sure to turn off the power when not in use.
For safety reasons, be sure to turn off the power of all the devices when the CR-2 is
not being used.
Also, remove the power plug from the AC outlet and put on the cover when the
CR-2 is not going to be used for a long time.
Otherwise, dust or any foreign matter may accumulate and result in fire.
Do not touch the main unit or the chin rest while they are
moving.
The main unit and the chin rest move to the center position when the CR-2 main
unit is turned on or a study is finished with the control software. Do not touch the
main unit or the chin rest while they are moving. Keep the patient’s chin away from
the chin rest.
CAUTION
Prohibited
Before packing the CR-2, return the main unit and chin rest to
their initial positions.
Lower the main unit and chin rest to the bottom. To automatically lower them, turn
on the power while holding down the set button.
Inspect daily and periodically.
For safety reasons, before using the CR-2, be sure to perform the daily inspection.
Have a periodically inspection performed for the CR-2 at least once a year by a
Canon designated representative to maintain its performance and reliability.
Do not turn off the CR-2 or the computer during image
capture, data transfer, or backup.
Doing so might damage the computer or corrupt the data.
Prohibited
Prohibited
Do not disconnect the cable between the CR-2 and the
computer during image capture or data transfer.
Doing so might damage the computer or corrupt the data.
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2 Safety
Notes on Using CR-2
Digital camera
• The attached digital camera is designed for the CR-2. The specifications differ from commercially
available Canon digital cameras. Use only for observing and taking photographs of peoples’ eyes.
Do not detach the digital camera from the main unit to use separately. Otherwise, failure of the
CR-2 may result.
• If any problems occur or repairs are needed with the CR-2’s digital camera, contact your sales
representative or local Canon dealer.
Before use
• Inspect the CR-2 daily. Make sure that no foreign matter is present that can affect image readings
or diagnoses.
• Check and clean the objective lens before taking an image. Any stains or scratches on the
objective lens will appear as white spots.
• Sudden heating of a room during winter or in cold regions may cause condensation to form on the
objective lens or on optical parts inside the CR-2. In this case, wait until condensation disappears
before taking images.
• Do not touch the lens of the retinal camera or the mirror of the digital camera when attaching and
detaching the digital camera from the retinal camera. If any dirt, fingerprints, dust, or other foreign
objects are on the lens or mirror, you will not be able to take a good image.
After use
• After using the CR-2, turn off the power, cover the objective lens with the objective lens cover to
protect it from dust, and place the dust cover over the CR-2. You cannot take good images if the
objective lens is dusty.
• If the digital camera is detached and left unattached, dirt and dust may enter the retinal camera
and the digital camera. Be sure to always attach the caps to their respective mounts.
Cleaning and disinfection
• Do not allow the blower to touch the lens.
• Do not wipe or rub the lens if there is dirt or dust on it. Doing so could scratch the lens.
• Do not wipe the lens with disinfectant ethanol, eyeglass cleaner, or silicone-coated paper. Doing
so could corrode the surface of the lens or leave streaks.
• Do not clean the outside of the CR-2 with a lens cleaner. Doing so could damage the outside of
the CR-2.
• Never use alcohol, benzine, thinner, or other solvents to clean the outside of the CR-2. Doing so
damages the outside of the CR-2.
• Never use disinfectant ethanol to clean the outside of the CR-2, with the except of the forehead
rest and the chin rest. Doing so damages the outside of the CR-2.
• If the chin rest paper is not being used, disinfect the chin rest for each patient in the same manner
as you do for the forehead rest.
• Carry out all cleaning, sterilization and disinfection procedures specified in the instruction manual
for each peripheral device in the system.
13
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2 Safety
Environment of use
• Use, store, and transport the CR-2 in an environment that is within the range of the following
conditions. Use the original packaging to store or ship it.
Temperature Humidity
10 to 35°C
Atmospheric pressure
700 to 1060 hPa
Environment of use
30 to 90% RH (no
condensation)
Storage and transportation –30 to 50°C
environment
10 to 95% RH (no
condensation)
700 to 1060 hPa
• Do not install, store, or leave the CR-2 in a very hot or humid environment. Also, do not use the
CR-2 outside. Doing so may cause a malfunction or misoperation.
• Always try to keep the room as clean as possible. After many years of usage, airborne dust in the
room may get on the objective lens as well as the optical parts in the main unit. You cannot take
good images if dust is on the equipment.
• When the CR-2 is not being used, attach the objective lens cap and place the dust cover over the
CR-2.
Installation
• Request your sales representative or local Canon dealer to install the CR-2.
• A strong shock to the CR-2 may put it out of alignment. Please handle the unit carefully.
Transportation
• Lower the main unit and chin rest to the bottom. To automatically lower them, turn on the power
while holding down the set button.
• Be sure to turn off the CR-2’s power switch, remove the AC plug from the outlet, and disconnect
any cables connected to other equipment.
• When lifting the main unit, do not hold the head rest or digital camera. Hold the main unit by the
indentations for lifting at its front and rear, and keep it level.
• When transporting the CR-2, align the stage with the base, and then lock the stage with the stage
lock lever.
• The CR-2 needs to be protected from vibration and shocks when it is transported in a vehicle or
over long distances. For details, contact your representative or local Canon dealer.
14
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2 Safety
Disposal
Disposal of this product in an unlawful manner may have a negative impact on human health and
on the environment. Therefore, when disposing of this product, be absolutely certain to follow the
procedure which conforms with the laws and regulations applicable to your area.
European Union (and EEA*) only
This symbol indicates that this product is not to be disposed of with your
household waste, according to the WEEE Directive (2002/96/EC) and your national
law. This product should be handed over to a designated collection point, e.g.,
on an authorized one-for-one basis when you buy a new similar product or to an
authorized collection site for recycling waste electrical and electronic equipment
(EEE). Improper handling of this type of waste could have a possible negative
impact on the environment and human health due to potentially hazardous
substances that are generally associated with EEE. At the same time, your
cooperation in the correct disposal of this product will contribute to the effective
usage of natural resources. For more information about where you can drop off
your waste equipment for recycling, please contact your local city office, waste
authority, approved WEEE scheme or your household waste disposal service.
For more information regarding return and recycling of WEEE products, please visit
www.canon-europe.com/WEEE.
* EEA: Norway, Iceland and Liechtenstein
15
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2 Safety
Rating Label Display
The position and contents of the label attached on the CR-2 is shown below.
Follow the information on the label to use the CR-2 appropriately.
The following table describes the marks and indications on the rating label.
Alternating current
Type B
Class I device indicating manufacturer’s declaration of conformance
with the Annex VII of the Medical Device Directive, 93/42/EEC
Certification mark that shows the product has passed the tests by
TUV Rheinland of conformity with the medical device regulations in the
European Union.
Product that WEEE directive, Directive on Waste Electrical and
Electronic Equipment, 2002/96/EC, requires separate collection. The
directive is effective in the European Union only.
Certification mark that indicates the product complies with UL 60601-
1 and CAN/CSA 22.2 No. 601.1, that specifies protection against fire,
electric shock, and mechanical hazards
Caution: Check the documentation provided.
Caution: Federal law (USA) restricts this device to sale by or on the
order of a physician.
Year and month of manufacture
Example: October 2011
Serial number in six digits
Example: 123456
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Names of Parts
3
Retinal Camera
1
2
3
4
12
13
5
6
7
8
14
15
16
17
9
10
11
18
1
2
3
4
Digital camera
12 Height adjustment mark
13 Main unit
Power switch for the digital camera
Digital camera cover
14 Operation panel
15 USB connector
16 AC power connector
17 Power switch for main unit
18 Stage
Observation monitor
For viewing the anterior segment and retina.
5
6
7
Operation lever
Shutter release button
Alignment button
Switches between a view of the anterior segment
and the retina.
8
9
Main unit vertical movement ring
Turn right: Main unit moves up.
Turn left: Main unit moves down.
Focus ring
Turn to focus the image.
10 Stage lock
11
Indentation for lifting
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3 Names of Parts
19
20
21
26
22
23
a
b
c
d
24
27
25
19 Connector for external eye fixation lamp
26 Diopter compensation knob
a No diopter compensation
(with cap)
Connector for the external eye fixation lamp (sold
b Negative compensation
c Positive compensation
separately).
20 Forehead rest
21 Objective lens
22 Objective lens cap
23 Head rest
d Anterior segment photography
27 Base
24 Chin rest
25 Indentation for lifting
18
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3 Names of Parts
Operation Panel
1
2
6
7
3
4
5
8
1
2
Flash intensity button/lamp
+: Flash intensity increases.
6
FIX TARGET button
Move up, down, right, and left to move internal eye
fixation lamp.
–: Flash intensity decreases.
7
8
Set button/lamp
Internal eye fixation lamp blinks.
Observation light brightness button/lamp
+: Observation light brightness increases.
POWER lamp
–: Observation light brightness decreases.
Lights when power is turned on.
3
4
x2 photography button/lamp
Enables x2 photography function. (See page 30)
Small pupil photography button/lamp
Enables small pupil photography function. (See
page 30)
5
CHIN REST button
Top: Raises chin rest.
Bottom: Lowers chin rest.
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3 Names of Parts
Observation Monitor
During anterior segment observation
4
5
1
2
3
6
1
Photography ready lamp
Green: Ready to shoot
4
5
6
Left/right eye indicator
R: Right eye
Red: Not ready to shoot
L: Left eye
2
3
Pupil alignment circles
Diopter compensation knob position
indicator
Observation light brightness indicator
: Anterior segment photography
Flash intensity indicator
During retinal observation (with x1.3 magnification)
1
7
8
9
2
3
4
5
10
6
11
1
Indicator for top limit of position of main
7
8
x2 photography range
unit
Diopter compensation knob position
indicator
Appears when main unit has reached top limit.
None: No diopter compensation
2
3
4
Focus indicator
+: Positive compensation
–: Negative compensation
WD guide (green)
Indicator for bottom limit of position of
main unit
9
Small pupil photography range
Appears when main unit has reached bottom limit.
10 Internal eye fixation lamp position indicator
11 Focus lens position indicator
5
6
x2 photography indicator
Small pupil photography indicator
20
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Basic Operations
4
Flow of Operation
The flow of operations for retinal photography is as follows.
Connect the cables if necessary as described in “Connecting Cables” (see page 22).
Preparing for an Examination (page 22)
Patient Setup (page 24)
Alignment (page 25)
Small Pupil Photography Function (page 30)
x2 Photography (page 30)
Diopter Compensation (page 31)
Anterior Segment Photography (page 32)
Photography (page 28)
Finishing an Examination (page 29)
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4 Basic Operations
Connecting Cables
Connect the CR-2 to a computer in which the supplied software, the Rics NM 2, has been installed.
• Do not plug or unplug the power plug with wet hands.
• Do not use any power cord other than the one supplied.
Otherwise, fire or electric shock may result.
WARNING
Make sure that the power switch for the CR-2 is turned off.
1
2
Connect the power cord and the USB cable to the
retinal camera.
Insert the power plug all the way into an AC outlet.
3
4
Connect the other end of the USB cable to the USB connector of the PC.
Use a high-speed AB type USB cable that is shorter than three meters. For details, contact your
sales representative or local Canon dealer.
Preparing for an Examination
• To prevent the risk of infection, wipe the forehead rest with disinfectant ethanol for each patient.
CAUTION
For details on how to disinfect, consult a specialist.
• To ensure cleanliness, replace the chin rest paper for each patient.
Turn on the computer and start the Rics NM 2.
1
2
If the digital camera is off, turn the switch to the ON.
If the Mode Dial is set to anything other than , an image cannot be taken.
While holding down the button at the center of the Mode Dial, turn the dial to
.
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4 Basic Operations
Remove the objective lens cap and turn the retinal
camera's power switch to the ON position.
3
The POWER lamp lights and the set lamp blinks.
The CR-2 automatically does an initialization sequence (internal
check and initialization of driving parts). After the initialization
the parts of the main unit stop in their center positions.
The main unit and the chin rest move to the center position when the CR-2 is turned on. Do not
touch the main unit or the chin rest while they are moving. Keep the patient’s chin away from the
main unit and chin rest when they are moving.
CAUTION
Power-saving function
If the power is on and the buttons on the operation panel are not operated for over 10 minutes, the
power-saving function is activated. The POWER lamp blinks while in power saving mode.
To return to normal mode, press any button on the operation panel, move the stage right or left, or
turn the diopter compensation knob.
Make sure the diopter compensation knob is in the 0
position.
4
You can also check the position of the diopter compensation knob on the observation monitor.
Press and hold the unlock button and slide the stage
lock to the UNLOCK side.
5
6
Align the mark on the stage lock and the mark on the left side
of the base.
The stage lock is released.
Move the stage towards you with the operation lever.
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4 Basic Operations
Disinfect the forehead rest and replace the chin rest paper.
7
If chin rest paper is not being used, disinfect the chin rest also.
• To prevent the risk of infection, wipe the forehead rest with disinfectant ethanol for each patient.
CAUTION
For details on how to disinfect, consult a specialist.
• To ensure cleanliness, replace the chin rest paper for each patient.
Patient Setup
Start an examination on the Rics NM 2.
1
Enter the patient’s information.
The set lamp lights and the observation monitor turns on.
Seat and position the patient.
2
3
• Instruct the patient to remove his/her contact lenses or glasses, if he/she is wearing them.
• Have the patient place his/her chin on the chin rest and his/her forehead against the forehead rest.
Adjust the heights of the optical bench and chair so the patient is comfortable.
Move the chin rest with the CHIN REST button so that the patient's eye is aligned with
the height adjustment mark.
Height adjustment
mark
Chin rest rises
Chin rest lowers
Move the stage toward the eye to be photographed.
4
• Do not place your hands or fingers on the base.
CAUTION
• Instruct the patient not to place the patient’s hands and fingers there.
Otherwise, your or the patient’s hands or fingers may be pinched, possibly resulting in injury.
Hold the operation lever, pull it toward you, and then move the
stage.
24
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4 Basic Operations
Alignment
Align the retinal camera with the eye to be photographed.
1
When adjusting the position of the retinal camera in the front-back direction, slowly bring the main
unit closer to the patient while looking at the patient’s eye from the side. The patient’s eye may be
injured if the objective lens makes contact with it.
CAUTION
1. Move the stage until the eye to be photographed appears in the observation monitor.
2. Adjust the center of the patient's pupil and the pupil alignment circles.
3. Have the patient stare at the green blinking internal eye fixation lamp.
Pupil alignment circles
During examination of the anterior segment of a patient who is extremely near- or far-sighted, the
patient may not be able to see the internal eye fixation lamp.
• To move the main unit slightly to the left or right, tilt the
operation lever to the left or right.
• To move the main unit slightly to the front or back, tilt the
operation lever to the front or back.
• To move the main unit up or down, turn the main unit
vertical movement ring.
When the vertical position cannot be fully adjusted by using the operation lever
Adjust the height of the chin rest with the CHIN REST button to raise or lower the patient's face.
25
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4 Basic Operations
Tilt the operation lever forward or backward to unify the top and bottom of the image of
the pupil.
2
When the pupil is smaller than the inner pupil alignment circle, images cannot be taken
properly.
Darken the room further to dilate the patient's pupil more. If the patient's pupil does not dilate
enough, use the small pupil photography function (see page 30).
Press the alignment button.
3
4
The retina appears in the observation monitor and the internal
eye fixation lamp blinks for three seconds.
Adjust the observation light brightness with the
observation light brightness button.
Guidelines for observation light brightness
Adjust to the lowest possible brightness level to reduce the strain on the patient's eye.
Observation monitor brightness adjustment
Use the Rics NM 2 to adjust the brightness of the observation monitor. See the Rics NM 2 manual
for details.
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4 Basic Operations
Have the patient stare at the internal eye fixation lamp to fix the part for the photograph.
5
Take the following steps to guide the patient’s eye: Press the FIX TARGET buttons up, down, left, and
right to move the internal eye fixation lamp to your desired position and then press the set button
to make it blink. If the eye cannot be guided by the internal eye fixation lamp, use the external eye
fixation lamp (sold separately).
Set button
Press the set button for at least two seconds to reset the position of the internal eye fixation lamp.
See the Rics NM 2 manual for details.
Turn the focus ring to align the split lines into a single line.
6
The image enlarges while the focus ring is being turned.
Split line
Correct
Incorrect
Incorrect
Focus ring
When the split lines do not align
If the patient's diopter range is outside the –10 to +15 D, it is not possible to focus with the focus
indicator. If this happens, use the diopter compensation function (see page 31), and focus the image
until it is sharp.
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4 Basic Operations
Photography
Do a preliminary check before taking photos.
1
a. The photography ready lamp lights green.
b. The working distance dots appear sharpest.
c. The working distance dots are on the extension line of the WD guides.
d. The split lines form a single line.
a
b,c
d
Photography ready lamp
• Green: Ready to shoot.
• Red: Preparing to shoot. Wait until the lamp lights green.
Flash intensity adjustment
The flash intensity is set in advance to the standard level.
Every time the flash intensity button is pressed the flash
intensity increases by 0.3 stop.
Appearance of flare
Even if the working distance dots are adjusted to be extremely clear, flare may appear around the
retinal image depending on the patient’s eye.
Press the shutter release button.
2
3
The image of the retina and the examination information appear on the Rics NM 2 screen.
Check the photographed image.
Check that the image is normal and there are no errors in the examination information.
To take images of the other eye, repeat beginning with step 1 of Alignment (see page 25).
If flare appears
See “7 Troubleshooting” (see page 40) and follow the procedure.
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4 Basic Operations
Finishing an Examination
Save the images on the Rics NM 2 and end the examination.
1
The set lamp starts blinking and the observation monitor turns off.
The main unit and the chin rest move to the center position when a study is finished with the
control software. Do not touch the main unit and the chin rest while they are moving.
CAUTION
Align the stage with the base and slide the stage lock
to LOCK side to lock the stage.
2
Align the mark on the stage lock and the mark on the right side
of the base.
Turn off the power to the CR-2.
3
4
Exit the Rics NM 2 and turn off the computer.
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Photography Auxiliary Functions
5
The section describes how to use x2 photography, small pupil photography function, diopter
compensation, and anterior segment photography. Instructions are also included for connecting an
optional external monitor.
x2 Photography
You can take and save images that are within the x2 photography range on the observation monitor.
Press the x2 photography button.
1
The lamp on the x2 photography button lights, and the x2 photography indicator and x2 photography
range marks appear on the observation monitor.
x2 photography range mark
x2 photography indicator
Take the image.
2
The image in the x2 photography range appears on the Rics NM 2 screen.
Small Pupil Photography Function
If the patient’s pupil does not dilate enough, use the small pupil photography function. When the
function is used, pupil diameters 3.3 mm or larger can be photographed.
Press the small pupil photography button.
1
The lamp on the small pupil photography button lights, and the small pupil photography indicator and
a dotted circle appear on the observation monitor.
Effective range of photography
Small pupil photography indicator
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5 Photography Auxiliary Functions
Take the image.
2
Press the small pupil photography button again to finish the small pupil photography.
• Do not use the small pupil photography function if the patient's pupil is large enough. The image
will be overexposed.
• The image may contain flare around the edges of the image outside the photography range.
Diopter Compensation
If because of the patient's diopter the image cannot be brought into focus by turning the focus ring,
use the diopter compensation knob to change the position. Insert the diopter compensation lens into
the CR-2 and take the photograph.
Diopter compensation mark
0
Negative
Positive
The CR-2 can provide appropriate images if the diopter of the patient’s eye is within the respective
ranges below.
• 0 position: –10 to +15 D
• – position: –31 to –7 D
• + position: +11 to +33 D
Note that when the diopter compensation knob is set to the – or + position, the focus indicator does
not appear. Turn the focus ring to focus the retinal image in a position that brings the image clear on
the observation monitor.
When operating the diopter compensation knob, set it precisely to the 0, –, or + position. If the
knob is not aligned with the position noted above, the retinal image is not captured correctly.
31
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5 Photography Auxiliary Functions
Anterior Segment Photography
This function makes it possible to photograph the anterior segment. It is also possible to use the x2
photography function at the same time.
Do not allow external light that contains infrared to enter the position being photographed.
Switch the diopter compensation knob to the anterior segment photography position.
The anterior segment photography mark appears on the observation monitor.
Anterior segment photography mark
1
Anterior segment
photography
Move the operation lever to align the area to be photographed in the center of the
observation monitor.
2
3
Tilt the operation lever to the front or back to focus on the area to be photographed.
• Focus the image so that the area to be photographed can be seen as clearly as possible.
• Make sure that the photography ready lamp light is green.
Press the shutter release button.
4
The image of the retina appears on the Rics NM 2 screen.
To take images of another position, repeat steps from step 2.
External Monitor
The image on the observation monitor can be viewed on an external monitor.
Contact your sales representative or local Canon dealer about which external monitors and HDMI
mini cable can be used.
• Before connecting or disconnecting the HDMI cable, be sure to turn off the retinal camera and
all other devices.
• Use an external monitor that conforms to IEC60601-1 or IEC60950-1. If you use a monitor that
conforms to IEC60950-1, be sure to also use the isolation transformer that is designated by
Canon. For details, contact your sales representative or local Canon dealer.
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5 Photography Auxiliary Functions
Remove the digital camera cover.
1
2
Connect the HDMI cable to the digital camera.
1. Securely insert the HDMI cable into the HDMI mini output terminal on the digital camera.
2. Fit the HDMI cable into the space in the cover, and place the cable in the notch.
Notch
Attach the digital camera cover.
3
1. Hook the digital camera cover hook onto the strap mount of the digital camera.
2. While taking care to avoid pinching the HDMI cable, insert the cover screw to secure the digital
camera cover.
Cover screw
Connect the HDMI cable to the external monitor.
4
5
Connect the HDMI cable to the HDMI input terminal on the external monitor.
Turn on the power to the retinal camera and the digital camera.
The image is displayed on the external observation monitor. No image is displayed on the observation
monitor of the retinal camera.
33
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Maintenance
6
This section outlines the maintenance instructions for the CR-2: daily inspection, cleaning,
disinfecting, refilling chin rest paper, and removing/installing the digital camera.
• For safety reasons, before using the CR-2, be sure to perform the daily inspection.
CAUTION
• Have a periodically inspection performed for the CR-2 at least once a year by a Canon
designated representative to maintain its performance and reliability.
Daily Inspections
Perform the following inspections before using the CR-2 to insure that it is used safely and correctly.
If a problem is found during the inspection and you are unable to correct the problem, please contact
your sales representative or local Canon dealer.
Checks before turning on the power
Check the following items before turning on the power.
Cables
1) The power cord and connection cable are not damaged and their insulation is not torn.
2) The power cord is fully and securely inserted into the AC connector on the main unit and the AC
outlet.
Main unit
1) The digital camera cover and parts are not damaged or loose.
2) The stage moves smoothly when the operation lever is tilted back and forth and right to left.
3) The digital camera is securely installed.
4) The stage lock operates properly.
5) There are no scratches or dirt on the objective lens. Clean the objective lens if it is dirty (see page 35).
Checks after turning on the power
Turn on the CR-2 and start the Rics NM 2. Check the following items after starting an examination.
Main unit
1) The power lamp lights.
2) The observation light brightness changes as the observation light brightness button is pressed.
3) A flash is emitted.
4) The main unit moves up and down smoothly as the main unit vertical movement ring is turned.
5) The chin rest moves up and down smoothly as the CHIN REST button is pressed.
Photographed image
1) Foreign objects that affect the reading of the images or diagnosis do not appear in the
photographed image. Place a piece of white paper in front of the objective lens and photograph
an image under the following conditions:
• Flash intensity:
Standard
• Diopter compensation knob:
• Focus ring:
0
Turned clockwise more than 1 rotation.
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6 Maintenance
Cleaning the Objective Lens
• Do not wipe or rub the objective lens if there is dirt or dust on it. Doing so could scratch the
surface of the lens.
• Do not wipe the objective lens with disinfectant ethanol, eyeglass cleaner, or silicone-coated
paper. Doing so could corrode the surface of the lens or leave streaks.
For information about lens cleaning paper, lens cleaner, and blowers, contact your sales
representative or local Canon dealer.
If the objective lens is dirty, clean it according to the procedure below.
Check for any dirt.
1
2
Illuminate the objective lens with a penlight to check for dirt.
Blow away any dust or dirt.
Use a blower to blow away any dust or dirt on the lens. Do not
use a brush to dust off.
Do not allow the blower to touch the objective lens.
Wipe the objective lens.
3
1. Slightly dampen a lens cleaning paper with lens cleaner
and lightly wipe the objective lens.
2. Starting from the center of the lens, wipe the lens in spirals
toward the circumference.
3. Change the lens cleaning paper and wipe the objective
lens until the dirt is gone and there are no streaks.
Use lens cleaning paper and lens cleaner designated by Canon.
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6 Maintenance
Cleaning the Image Sensor
The digital camera has a self-cleaning sensor unit. Dirt and dust on the front surface of the imaging
sensor are automatically removed when the power is turned on or off. This function makes it possible
to remove the majority of dirt and dust that may interfere with images. It is not necessary to be aware
of this function during normal usage.
To use the self-cleaning sensor unit for cleaning, follow the procedure below.
Make sure that the power switch for the retinal camera is turned off.
1
2
Switch the digital camera's power switch from on to off.
The self-cleaning sensor unit starts and the imaging sensor is cleaned.
Check that the dirt and dust have been removed.
3
4
Switch the digital camera's power switch to on, photograph an image and check the
image.
If the above procedure does not remove the foreign object, the cause may not be dirt or dust.
Contact your sales representative or local Canon dealer.
Cleaning the Outside of the CR-2
• Before cleaning the CR-2, be sure to turn off the power of all connected devices and unplug the
WARNING
power cord from the AC outlet.
• Do not use alcohol, benzine, thinner or any other flammable cleaning solvent.
Otherwise, fire or electric shock may result.
Do not clean the outside of the CR-2 with lens cleaner. It may corrode the material of the outside
of the CR-2.
If the outside of the CR-2 is dirty, wipe it twice with a soft cloth. First use a cloth that has been soaked
in diluted neutral cleanser and well wrung out. Then use a cloth that has been soaked in water and
well wrung out.
36
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6 Maintenance
Disinfecting the Forehead Rest
• To prevent the risk of infection, wipe the forehead rest with disinfectant ethanol for each patient.
• The forehead rest may be corroded if a disinfectant other than ethanol is used.
For details on how to disinfect, consult a specialist.
CAUTION
Use a sanitized gauze or wipe that includes disinfectant to clean the forehead rest for each patient.
Refilling Chin Rest Paper
If the chin rest paper is not being used, be sure to disinfect the chin rest for each patient. For
CAUTION
details on how to disinfect, see the Disinfecting Forehead Rest section above.
Pull out the right and left chin rest holding pins.
1
2
3
Insert the holding pins into the holes on the right and left of the chin rest paper.
Attach the chin rest paper to the chin rest with the pins pressing into the holes on the
chin rest.
Chin rest paper is a consumable product (sold separately). To purchase chin rest paper, contact
your sales representative or local Canon dealer.
Attaching and Removing the Digital Camera
The CR-2 is equipped with a specialized digital camera. It is not necessary to attach or remove the
digital camera during normal usage.
To replace the digital camera, follow the procedure below to remove and attach the digital camera.
Although it is not recommended, if you need to remove and attach the digital camera, take the
following precautions.
• Work quickly in a location where there is little dust.
• When removing the digital camera for storage, be sure to attach the supplied camera mount cap
to the retinal camera and the body cap to the digital camera.
• Wipe off any dust from the camera mount cap and the body cap before attaching them.
• Do not touch the lens in the main unit or the mirror in the digital camera. It is not possible to take
good images if dirt, fingerprints, or dust are on these parts.
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6 Maintenance
Removing the digital camera
Turn off the power to the retinal camera and remove the plug from the AC outlet.
1
2
Loosen the cover screw and remove the digital camera
cover.
Remove the cables from the digital terminal and the
remote control terminal.
3
4
5
6
Remove the DC coupler.
1. Open the battery compartment cover on the digital
camera, and then slide the battery lock lever to remove the
DC coupler.
2. Close the battery compartment cover.
While holding down the lens release button
on the digital camera, turn the digital camera
counterclockwise to remove it.
Attach the caps to the retinal camera and the digital camera mount.
38
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6 Maintenance
Installing the digital camera
First be sure to check the following items.
1
• The power to the retinal camera is off.
• The power plug of the retinal camera is not plugged into an electric outlet.
Attach the digital camera to the retinal camera.
2
1. Align the positions of the mounting alignment marks on the retinal camera and the digital camera.
2. Fit the digital camera's lens mount to the retinal camera's mount.
3. Turn the digital camera clockwise until it clicks.
Mounting alignment mark
Attach the DC coupler to the digital camera.
3
4
5
1. Open the battery compartment cover of the digital camera,
and attach the DC coupler.
2. Pass the cord for the DC coupler through the DC coupler
cord hole and then close the battery compartment cover.
Open the terminal cover of the digital camera and
attach the cables to the digital terminal and the remote
control terminal.
Attach the digital camera cover to the digital camera.
1. Hook the digital camera cover hook onto the strap mount
of the digital camera.
2. Insert the cover screw to secure the digital camera cover.
39
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Troubleshooting
7
If any of the symptoms listed here occurs or if a warning appears in the Rics NM 2 while using the
CR-2, try the relevant remedy described below.
If these remedies do not eliminate the symptoms or the warning, turn off the power and contact
your sales representative or local Canon dealer. Be ready to provide a detailed description of the
symptoms and message.
Symptom
Cause and remedy
The power cord has been disconnected. Turn off the power to
the retinal camera and reconnect the power cord.
The power lamp does not light
when the power is turned on.
The power cord has been cut. Contact your sales
representative or local Canon dealer.
5 short beeps sound and the
operation panel lamps blink when
the power is turned on.
A system error has occurred. Contact your sales representative
or local Canon dealer.
The observation monitor is dim
and hard to see.
Adjust the brightness of the observation monitor. See the Rics
NM 2 manual.
The observation monitor does not
turn on.
Turn on the digital camera.
An error appears on the
observation monitor.
A malfunction has been detected in the digital camera. Turn off
the power to the retinal camera and then turn it on again.
Err 06
Err 70
Sensor cleaning is not possible.
Photography is not possible due to an error.
The working distance dots are
hard to see.
The observation light is too bright. Reduce the observation light
brightness.
The split lines are hard to see.
The working distance dots are not The retinal camera and the eye are not aligned. Align them
visible.
correctly.
The retinal camera and the eye are not aligned. Align them
correctly. If flare still appears, refer to items 1 through 4 below
and try taking the photo again.
Flare appears in the image.
1)
2)
3)
4)
White flare appears around The retinal camera and the patient’s eye are separated. Move
the edges of the image. the objective lens closer to the patient’s eye.
Orange flare appears around The retinal camera and the patient’s eye are too close. Move
the edges of the image.
the objective lens away from the patient’s eye.
White flare appears on the
left side of the image.
The retinal camera is too close to the left side of the patient’s
eye. Move the objective lens to the right.
White flare appears on the
right side of the image.
The retinal camera is too close to the right side of the patient’s
eye. Move the objective lens to the left.
The patient's pupil is not dilated enough. Dilate the patient’s
pupil. If the pupil is still too small, enable the small pupil
photography function.
Eyebrows or eyelashes are blocking the pupil. Instruct the
patient to open his/her eye wider.
The split lines are not visible.
The patient's eye is cloudy. Focusing cannot be performed with
the split lines.
The diopter compensation knob is set to either negative or
positive. Set it to the 0 position.
The split line lamps are not lit.
40
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7 Troubleshooting
Symptom
Cause and remedy
The diopter patient's eye is outside the range of –10 to +15 D.
Use the diopter compensation function, turn the focus ring, and
focus on the position where the images of the retina look clear
at the same time.
The split lines do not align.
The patient's pupil is not dilated enough. Dilate the patient’s
pupil. If the pupil is still too small, enable the small pupil
photography function.
The retinal camera and the eye are not aligned. Align them
correctly.
Focus the image.
Eyebrows or eyelashes are blocking the pupil. Instruct the
patient to open his/her eye wider.
Cannot capture good images.
The patient's eye is cloudy. Clear images cannot be captured if
this is the case.
Adjust the flash intensity, patient's diopter, and small pupil
photography function.
The objective lens is dirty. Clean the objective lens (see page 35).
The patient is wearing contact lenses. Instruct the patient to
remove his/her contact lenses.
There is dirt or dust on the objective lens. Clean the objective
lens (see page 35).
Black spots or any artifacts
appear in the same place in every
captured image.
Dirt or dust is stuck to the imaging sensor of the digital camera.
Use the self-cleaning sensor unit to clean it. (see page 36).
The objective lens is dirty. Clean the objective lens (see page 35).
White spots are visible on the
captured image.
The patient's eyelashes are interfering with the image. Instruct
the patient to open his/her eye wider, and capture another
image.
41
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Appendix
Specifications
Field angle
45°
Photographic magnification
Required pupil diameter
1.1 x (image size on the sensor)
4.0 mm or greater (3.3 mm when using small pupil photography
function)
Working distance
35 mm
Focus adjustment range
–10 to +15 D (without compensation lens)
–31 to –7 D (when using negative compensation lens)
+11 to +33 D (when using positive compensation lens)
(Split-line alignment type focusing)
* 1 D = 1 m–1
Flash intensity
Linked to the photography mode
Can be set manually
Light source
Observation light source
Flash source
Infrared LED
White LED
Camera
Digital camera
Eye fixation lamp
Internal eye fixation lamp (LED)
External eye fixation lamp (sold separately)
Range of motion
Stage
100 mm side to side, 70 mm front to back
32 mm
Main unit vertical
movement
Chin rest range of motion
Power supply rating
Dimensions
60 mm
AC 100 V to 240 V, 50/60 Hz, 1 A to 0.4 A
305 (W) × 500 (D) × 473 (H) mm
Approximately 15 kg (including 0.8 kg digital camera)
Weight
42
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Appendix
EMC (Electromagnetic Compatibility)
The CR-2 is designed and tested to comply with IEC 60601-1-2 (EN 60601-1-2), the applicable regulations regarding EMC
for medical devices. The CR-2 needs to be installed and put into service according to the EMC information stated as
follows.
If this equipment causes harmful interference to other devices, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving device.
• Increase the separation between the equipment.
• Connect this device into an outlet on a circuit different from that to which the other devices are connected.
If the problem cannot be solved with the above measures, stop using this equipment and consult your sales representative
or local Canon dealer.
Precautions on EMC
1. Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in the manual.
2. Portable and mobile RF communications equipment can affect medical electrical equipment.
3. Information regarding the cable affecting EMC is as follows.
To maintain the optimum EMC performance, use only the designated cables.
Name
AC Power Cord
Type
Non-Shielded
Length
3.0 m fixed-length
Max. 3.0 m
Remarks
Supplied
USB Cable
HDMI Cable
Shielded
Shielded
Not supplied
Not supplied
Max. 2.7 m
4. The use of accessories, transducers and cables other than those specified, with the exception of transducers and
cables sold by Canon sales representative or local Canon dealer as replacement parts for internal components, may
result in increased emissions or decreased immunity of the CR-2.
5. The CR-2 should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary,
the CR-2 should be observed to verify normal operation in the configuration in which it will be used.
43
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Appendix
Guidance and Manufacturer’s Declaration for Electromagnetic Emission
The CR-2 is intended for use in the electromagnetic environment specified below.
The customer or the user of the CR-2 should assure that it is used in such an environment.
Emission Test
Compliance
Group 1
Electromagnetic Environment – Guidance
The CR-2 uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electromagnetic equipment.
RF emissions
EN 55011
CISPR11
RF emissions
EN 55011
CISPR11
Class B
Class A
The CR-2 is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
Harmonic emissions
EN IEC 61000-3-2
Voltage fluctuations/flicker
emissions
Complies
EN IEC 61000-3-3*
* Not applicable to regions where the rated voltage is less than 220 V.
44
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Appendix
Guidance and Manufacturer’s Declaration for Electromagnetic Immunity
The CR-2 is intended for use in the electromagnetic environment specified below.
The customer or the user of the CR-2 should assure that it is used in such an environment.
IEC 60601
Immunity Test
Compliance Level
Electromagnetic Environment – Guidance
Test Level
Floors should be wood, concrete or ceramic
tile.
Electrostatic discharge
(ESD)
(2, 4, 6) kV contact
(2, 4, 8) kV air
(2, 4, 6) kV contact
(2, 4, 8) kV air
If floors are covered with synthetic material,
the relative humidity should be at least 30%.
IEC 61000-4-2
2 kV for power supply
2 kV for power supply
Electrical fast transient/
burst
lines
1 kV for input/output
lines
lines
1 kV for input/output
lines
Mains power quality should be that of a
typical commercial or hospital environment.
IEC 61000-4-4
1 kV differential mode
1 kV differential mode
Surge
Mains power quality should be that of a
IEC 61000-4-5
typical commercial or hospital environment.
2 kV common mode
2 kV common mode
<5% UT (>95% dip in
UT) for 0.5 cycles
<5% UT (>95% dip in
UT) for 0.5 cycles
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the CR-2 requires continued
operation during power mains interruptions,
it is recommended that the CR-2 be powered
from an uninterruptible power supply.
40% UT (60% dip in UT) 40% UT (60% dip in UT)
for 5 cycles for 5 cycles
70% UT (30% dip in UT) 70% UT (30% dip in UT)
for 25 cycles
for 25 cycles
IEC 61000-4-11
<5% UT (>95% dip in
UT) for 5 sec
<5% UT (>95% dip in
UT) for 5 sec
Power frequency
(50/60Hz) magnetic
field
Power frequency magnetic fields should be
at levels characteristic of a typical location in
a typical commercial or hospital environment.
3 A/m
3 A/m
IEC 61000-4-8
NOTE: UT is the a.c. mains voltage prior to application of the test level.
45
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Appendix
Guidance and Manufacturer’s Declaration for Electromagnetic Immunity
The CR-2 is intended for use in the electromagnetic environment specified below.
The customer or the user of the CR-2 should assure that it is used in such an environment.
IEC 60601
Immunity Test
Compliance Level
Electromagnetic Environment – Guidance
Test Level
Portable and mobile RF communications
equipment should be used no closer to any
part of the CR-2, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter
Recommended Separation Distances
d = 1.2 √P
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.5 GHz
Conducted RF
3 Vrms
3 Vrms
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 metres
(m).
IEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
3 V/m
3 V/m
IEC 61000-4-3
80 MHz to 2.5 GHz
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
surveya, should be less than the compliance
level in each frequency rangeb.
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered.
If the measured field strength in the location in which the CR-2 is used exceeds the applicable RF compliance level
above, the CR-2 should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the CR-2.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
46
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Appendix
Recommended Separation Distances between Portable and Mobile RF
Communications Equipment and Devices or the CR-2
The CR-2 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the CR-2 can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the CR-2 as recommended below,
according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum output
m
power of transmitter
150 kHz to 80 MHz
d = 1.2 √P
80 MHz to 800 MHz
d = 1.2 √P
800 MHz to 2.5 GHz
d = 2.3 √P
W
0.01
0.1
1
0.12
0.38
1.2
0.12
0.38
1.2
0.23
0.73
2.3
10
3.8
12
3.8
12
7.3
100
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m)
can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
47
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Appendix
Warranty and Repair Service
Service life
The service life of this product is eight years if specified inspections and maintenance are done.
About repairs
If a problem cannot be solved even after taking the measures indicated in “7 Troubleshooting” (see
page 40), contact your sales representative or local Canon dealer for repairs.
When requesting repair, please provide us with the following information.
Name of the instrument: CR-2
Serial number: 6-digit number on the rating label
Description of malfunction: Report as much detail as possible.
Time limit for supplying performance parts for repair
Performance parts (parts for repairs to maintain performance) will be stocked for eight years after
production of the CR-2 is discontinued.
Expendable parts replaced by service personnel
The following parts are consumable or may deteriorate because of characteristics of their material or
construction.
These parts cannot be replaced by the user. If these parts are found to be worn out or to have
deteriorated during daily or regular inspection, contact your sales representative or local Canon
dealer for repairs.
• Baseboard (USB connector)
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*L-IE-5176C*
CANON INC. Medical Equipment Group
30-2, Shimomaruko 3-chome, Ohta-ku, Tokyo 146-8501, Japan
Telephone: (81)-3-3758-2111
Distributed by:
CANON U.S.A., INC. Healthcare Solutions Division
15955 Alton Parkway, Irvine, CA 92618, U.S.A.
Telephone: (1)-949-753-4160
CANON EUROPA N.V. Medical Products Division
Bovenkerkerweg 59, 1185 XB Amstelveen, The Netherlands
Telephone: (31)-20-545-8926
CANON SINGAPORE PTE. LTD. Medical Equipment Products Division
1 HarbourFront Avenue, #04-01 Keppel Bay Tower, Singapore 098632
Telephone: (65)-6799-8888
CANON AUSTRALIA PTY. LTD. Optical Products Division
1 Thomas Holt Drive, North Ryde, Sydney N.S.W. 2113, Australia
Telephone: (61)-2-9805-2000
L-IE-5176C
0613P0.001
© CANON INC. 2012
Printed in Japan
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