Canon CR-1 Operation Manual
Before using the instrument, be sure to read this manual thoroughly.
Keep the manual where it is easily accessible.
Digital Retinal Camera
CR-1
Operation Manual
PLEASE NOTE
1. Please contact a Canon representative or distributor to have the instruments installed.
2. Computer, monitor, or other equipment used in the CR-1 fundus imaging system must be conforming to the
IEC60601-1/UL60601-1 or IEC60950/UL60950.
Furthermore all configurations shall comply with the system standard IEC 60601-1-1. If in doubt, consult
the technical services department or your local representative.
Be sure to also use an isolation transformer conforming to IEC60601-1/UL60601-1 when a computer or
monitor conforming to IEC60950/UL60950 is used.
3. To maintain compliance to IEC60601-1-2, it is recommended that the computer, monitor, or other equipment
configured with the CR-1 be evaluated to IEC60601-1-2 or FCC Part.15 Subpart B Class B and CISPR 24.
4. The user is responsible for the use and maintenance of the product.
We suggest that a member of the user’s staff be designated as being in charge of maintenance so as to
ensure that the product is kept in a safe and good condition.
Also, medical products must be used only by a qualified person.
5. This product may malfunction due to electromagnetic waves caused by cellular phones, transceivers, radiocontrolled toys, etc. Be sure to avoid having objects such as these, which affect this product, brought near
the product.
6. In no event will Canon be liable for direct or indirect consequential damage arising out of the use of this
product. Canon will not be liable for loss of image data due to any reason.
7. Reading of image and storage of data must be performed in accordance with the law of the country where
the product is being used. Also, the user is responsible for maintaining the privacy of image data.
8. The power cable supplied is designed to be used solely with this camera. Do not use it for any other
products.
9. Canon reserves the right to change the specifications, configuration and appearance of the product without
prior notice.
© CANON INC. 2008
All rights reserved.
Under copyright laws, this manual may not be copied, in whole or in part, without the written consent
of Canon.
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
.
* EEA : Norway, Iceland and Liechtenstein
(1)
Safety Information
Regulations
This instrument conforms to IEC 60601-1-2:2001.
For U.S.A. and Canada
• When the CR-1 is going to be operated at a voltage of 240V in USA or Canada, be sure to
connect the instrument to a center tapped voltage source.
• This instrument is a CLASS I EQUIPMENT according to UL60601-1.
• Grounding reliability can only be achieved when the equipment is connected to an equiva-
lent receptacle marked “Hospital Only” or “Hospital Grade”.
• The following mark indicates that the instrument is a Type B Applied Parts.
• The degree of protection against ingress of water is IPX0.
• This equipment is not suitable for use in the presence of a flammable anaesthetic mixture
with air or with oxygen or nitrous oxide.
• The mode of operation is Continuous Operation.
For EU Countries
• The following mark shows compliance of the instrument with Directive 93/42/EEC.
• This instrument is a CLASS I EQUIPMENT according to EN 60601-1.
• The following mark indicates that the instrument is a Type B Applied Parts according to EN
60601-1.
Für Deutschland
• Während des Betriebs liegt der Schalldruckpegel dieses Instruments bei 70 dB(A) oder
weniger gemäß ISO 7779.
WITH RESPECT TO ELETRIC SHOCK, FIRE MECHANICAL
AND OTHER SPECIFIED HAZARDS ONLY IN
ACCORDANCE WITH CAN/CSA C22.2 NO. 601.1,
MEDICAL EQUIPMENT CERTIFIED FOR CANADA
MEDICAL EQUIPMENT WITH RESPECT
TO ELETRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH UL60601-1
<CONTROL NUMBER 41C4>
(2)
Safety Information
Guidance and Manufacturer’s Declaration for EMC Directive
Electromagnetic Emissions
The CR-1 is intended for use in the electromagnetic environment specified below.
The user of the CR-1 should assure that it is used in such an environment.
Emission Test Compliance Electromagnetic Environment – Guidance
RF emissions
CISPR 11
GROUP 1
The CR-1 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
CISPR 11
Class B
The CR-1 is suitable for use in all establishments other
than domestic and those directly connected to the public
low-voltage power supply network that supplies buildings
used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Compliances
Safety Information
(3)
Electromagnetic Immunity
The CR-1 is intended for use in the electromagnetic environment specified below.
The user of the CR-1 should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment –
Guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
±(2, 4, 6) kV
contact
±(2, 4, 8) kV air
±(2, 4, 6) kV
contact
±(2, 4, 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 transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
±2 kV for power
supply lines
±1 kV for input/
output lines
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV differential mode
±2 kV common
mode
±1 kV differential mode
±2 kV common
mode
Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5% U
T
(>95% dip in
U
T
) for 0.5 cycle
40% U
T
(60% dip in UT)
for 5 cycles
70% U
T
(30% dip in UT)
for 25 cycles
<5% U
T
(>95% dip in
U
T
) for 5 sec
<5% U
T
(>95% dip in
U
T
) for 0.5 cycle
40% U
T
(60% dip in UT)
for 5 cycles
70% U
T
(30% dip in UT)
for 25 cycles
<5% U
T
(>95% dip in
U
T
) for 5 sec
Mains power quality should be that of a
typical commercial or hospital environment. If the user of the CR-1 requires
continued operation during power
mains interruptions, it is recommended
that the CR-1 be powered from an
uninterruptible power supply.
Power frequency
(50/60Hz) magnetic
field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
(4)
Safety Information
Immunity Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment – Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
3 Vrms
3 V/m
Portable and mobile RF communications
equipment should be used no closer to
any part of the CR-1, including cables,
than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separations distance
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).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey
a
, should be less than the compli-
ance level in each frequency range
b
.
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 reflections from structures, object 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 where the CR-1 is used exceeds the applicable RF compliance level
above, the CR-1 should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the CR-1.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
d1.2P=
d 1.2 P 80 MHz to 800 MHz=
d 2.3 P 800 MHz to 2.5 GHz=
Safety Information
(5)
Recommended Separation Distances
The CR-1 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the CR-1 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the CR-1 as recommended below, according to the maximum output power
of the communications equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz ~ 80 MHz 80 MHz ~ 800 MHz 800 MHz ~ 2.5 GHz
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100121223
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.
d 1.2 P = d 1.2 P = d 2.3 P =
(6)
Safety Information
General Safety Information
Follow the safety instructions in this manual and all warnings and cautions printed on the warning
labels. Ignoring such cautions or warnings while handling the product may result in injury or accident.
Be sure to read and fully understand the manual before using this product.
Keep this manual for future reference.
Meaning of Caution Signs
WARNING
This indicates a potentially hazardous situation which, if not heeded, could
result in death or serious injury to you or others.
CAUTION
This indicates hazardous situation which, if not heeded, may result in minor or
moderate injury to you or others, or may result in machine damage.
NOTE
This is used to emphasize essential information.
Be sure to read this information to avoid incorrect operation.
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Safety Information
(7)
Installation and Environment of Use
WARNING
Do not use or store the instrument near any flammable chemicals such as
alcohol, thinner, benzine, etc. If chemicals are spilled or evaporate, it may
result in fire or electric shock through contact with electric parts inside the
instruments. Also, some disinfectants are flammable.
Be sure to take care when using them.
CAUTION
Do not use or store the instrument in a location with the conditions listed
below. Otherwise, it may result in failure or malfunction, fall or cause fire or
injury.
• Close to facilities where water is used.
• Where it will be exposed to direct sunlight.
• Close to air-conditioner or ventilation equipment.
• Close to heat source such as a heater.
• Prone to vibration.
• Insecure place.
• Dusty environment.
• Saline or sulfurous environment.
• High temperature or humidity.
• Freezing or condensation.
CAUTION
Do not cover the vent holes on the cover.
Otherwise, the temperature in the instrument may rise and cause fire.
CAUTION
Place the instrument on a firm table.
Do not place it extremely near the edge of the table in order to avoid damage
or injury due to falling.
Installation Operation
WARNING
Do not connect the instrument with anything other than specified.
Otherwise, it may result in fire or electric shock.
Also, when other equipment is going to be connected to the instrument using
the connector for interface, be sure to check after the connection that leakage
current is within the tolerable value. For details, please contact a Canon representative or distributor.
Power Supply
WARNING
Only operate the instrument with the type of power supply indicated on the
rating label. Otherwise, it may result in fire or electric shock.
WARNING
Be sure to turn OFF the power before plugging or unplugging the cables as
indicated in this manual. Also, do not handle it with wet hands. Otherwise, you
may get an electric shock that may result in death or serious injury.
WARNING
Securely plug in the power cable into the AC outlet.
If contact failure occurs, or if dust or metal object comes in contact with the
exposed metal prong of the plug, fire or electric shock may result.
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(8)
Safety Information
WARNING
Be sure to hold the plug to disconnect the power cable.
If you pull the cable, the core wire may be damaged, resulting in fire or electric
shock.
WARNING
Do not cut or process the cables. Also, do not place anything heavy, including
the instrument on it, step on it, pull it, bend it, or bundle it.
Otherwise, the cable may be damaged, which may result in fire or electric
shock.
WARNING
Do not get the power for more than one instrument from the same AC outlet.
Otherwise, it may result in fire or electric shock.
CAUTION
Before connecting or disconnecting the cables, be sure to hold the instrument
firmly in order to ensure safety.
Otherwise, the main unit may fall over, possibly causing injury.
CAUTION
The instrument is shipped with a grounding type (three-core) power cable.
To reduce the risk of electric shock, always plug the cable into a grounded
power outlet.
CAUTION
To make it easy to disconnect the plug at any time, avoid putting any obstacles near the outlet.
Handling
WARNING
Never disassemble or modify the product as it may result in fire or electric
shock. Also, since the instrument incorporates high-voltage parts that may
cause electric shocks and other hazardous parts, touching them may cause
death or serious injury.
WARNING
Do not place anything on top of the instrument.
Otherwise, the object may fall and cause injury.
Also, if metal objects such as needle or clip falls into the instrument, or if liquid
is spilled, it may result in fire or electric shock.
WARNING
When the instrument is going to be moved, be sure to turn OFF the power,
unplug the power cable from the AC outlet, and disconnect other cables.
Otherwise, the cable may be damaged, which may result in fire or electric
shock.
Also, when the instrument is going to be carried, be sure to tighten the stage
unit lock button, grip the lift handles at the left and right of the bottom panel
and hold it horizontally.
Do not hold it by the digital camera (sold separately) or the face rest poles or
other parts, as they may come off and result in injury.
WARNING
Do not hit or drop the instrument. The instrument may be damaged if it
receives a strong jolt, which may result in fire or electric shock if the instrument is used without it being repaired.
CAUTION
Wipe the forehead rest and chin rest with ethanol or glutaraldehyde solution to
disinfect them each time a different patient uses the instrument in order to prevent infection.
Please consult a specialist for the procedure for disinfection.
Power Supply
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Safety Information
(9)
CAUTION
To ensure cleanliness, replace the chin rest paper whenever changing
patients.
CAUTION
When adjusting the forward position of the main unit, be sure to move the
main unit slowly toward the patient while looking from the side of the patient,
so as to prevent accidental contact of the objective lens with patient.
CAUTION
Do not place your hand or fingers between the stage and base. Also, ensure
that the patient does not place his/her hand or fingers there either. Otherwise,
fingers may be hurt.
CAUTION
When the instrument is not going to be used, turn OFF the power.
Also, unplug the power cable from the AC outlet when it is not going to be
used for a long time.
When Problem Occurs
WARNING
Should any of the following occur, immediately turn OFF the power of each
instrument, unplug the power cable from the AC outlet, and contact a Canon
representative or distributor.
• When there is smoke, odd smell or abnormal sound.
• When liquid has been spilled into the instrument or a metal object has
entered through an opening.
• When the instrument has been dropped and it is damaged.
Maintenance and Inspection
WARNING
For safety reasons, be sure to turn OFF the power when the inspections indicated in this manual are going to be performed. Otherwise, it may result in
electric shock.
WARNING
When the instrument is going to be cleaned, be sure to turn OFF the power,
and unplug the power cable from the AC outlet.
Never use alcohol, benzine, thinner or any other flammable cleaning agents.
Otherwise, fire or electric shock may result.
WARNING
Clean the plug of the power cable periodically by unplugging it from the AC
outlet and removing dust or dirt from the plug, its periphery and AC outlet with
a dry cloth. If the cable is kept plugged in for a long time in a dusty, humid or
sooty place, dust around the plug will attract moisture, and this could cause
insulation failure which could result in a fire.
WARNING
The instrument must be repaired by a qualified engineer only.
If it is not repaired properly, it may cause fire, electric shock, or accident.
CAUTION
For safety reasons, be sure to inspect the instrument before using it.
Handling
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Safety Information
Labels and Markings on the Instrument
The CR-1 has a label on it.
The label contents and its position are indicated below.
Contents
Safety Information..........................................................................................(1)
Regulations ............................................................................................(1)
Guidance and Manufacturer’s Declaration for EMC Directive ...............(2)
General Safety Information ....................................................................(6)
Labels and Markings on the Instrument ..............................................(10)
1. Features...................................................................................................... 1
2. Notes for Using the Instrument ................................................................... 2
3. Description .................................................................................................. 4
3.1 Main Unit ........................................................................................... 4
3.2 Operation Panel ................................................................................. 6
3.3 Monitor Display Screens .................................................................... 7
4. Operation .................................................................................................... 9
4.1 Preparation ........................................................................................ 9
4.2 Adjusting the Position and Focusing ............................................... 11
4.3 Photography .................................................................................... 18
5. Settings ..................................................................................................... 21
6. Daily Inspection and Maintenance ............................................................ 23
6.1 Inspection ........................................................................................ 23
6.1.1 Before Turning ON the Power ............................................... 23
6.1.2 Turning ON the Power ........................................................... 25
6.2 Before Calling a Service Technician ................................................ 26
6.2.1 Troubleshooting .....................................................................26
6.2.2 What to Do when These Displays Appear .............................28
6.3 Cleaning and Disinfection ................................................................ 29
6.3.1 Objective Lens ....................................................................... 29
6.3.2 Forehead Rest .......................................................................30
6.3.3 Cover and Monitor ................................................................. 30
6.4 Refilling the Chin Rest Paper .......................................................... 31
6.5 Power Cable Connections ............................................................... 32
Contents
6.6 Attaching and Removing the EOS Digital Camera .......................... 33
6.6.1 Attaching the EOS Digital Camera ........................................ 33
6.6.2 Removing the EOS Digital Camera ....................................... 34
6.7 Connecting the USB Cable .............................................................. 36
6.8 Carrying the Instrument ................................................................... 37
7. Service Information ................................................................................... 39
8. Main Specifications ................................................................................... 40
9. Components..............................................................................................41
-1-
1. Features
The Canon CR-1 digital retinal camera is used to take digital photographic retinal images of patient’s eyes
across a wide range (photographic angle of view of 45 degrees) in a naturally dilated state without the use
of mydriatics. It has the following features.
Compact size and superior operability
Compact dimensions and a light weight.
Since the main unit can be raised and lowered by the operation lever, and the chin rest became motor-
driven, the alignment procedure has dramatically improved.
Function for photographing small pupils supported
The camera can photograph small pupils when their field angle is 45° and the diameter is ø4 mm or more.
If it is hard to dilate the pupil of a patient’s eye, the small pupil photography function enables photographs
to be taken of pupils with a diameter of ø3.7 mm or more.
Optimum system for digital photography
By using the Retinal imaging control software NM system that is optimized for digital photography
(hereinafter called “control software”), the images photographed by the CR-1 can be browsed, processed,
stored, output to the DICOM storage server, exported to DICOM files and output to an inkjet printer.
High-speed image transfer is enabled using the USB 2.0 interface. In addition, depending on the
photograph condition, flash intensity and EOS digital camera are automatically set and other steps are
taken so as to optimize the photography work flow.
High-picture-quality, high-definition diagnostic images
Diagnostic images with a high picture quality and high definition can be obtained by using an EOS digital
camera which incorporates a large, high-definition CMOS sensor.
-2-
2. Notes for Using the Instrument
Before Use
• Check and clean the objective lens before taking an image, as any stains or scratches on it will appear
as white spots.
• Sudden heating of the room in cold areas will cause condensation to form on the objective lens or on
optical parts inside the instrument. In this case, wait until condensation disappears before performing
photography.
• Do not touch the lens part of the main unit and the mirror part of the digital camera when attaching and
detaching the digital camera from the main unit.
If any dirt, fingerprints, dust, and other foreign objects attaches to the lens or mirror part, you cannot
take a good image.
When Images are Taken
• Do not use the digital camera’s built-in flash.
After Use
• Turn OFF the power of the instrument. Place the cap over the objective lens, and place the dust cover
over the instrument.
You cannot take a good picture when the objective lens is dirty.
• If the EOS digital camera is removed and left unattached, dust and other foreign objects can enter the
main unit and the EOS digital camera. Be sure to always attach the caps to the respective mounts.
Cleaning and disinfection
• Do not let the tip of a blower touch the objective lens.
• Do not wipe off or rub the objective lens when there is dust or other substances on it.
This could scratch the lens surface.
• Never wipe the objective lens with disinfecting ethanol, eyeglass lens cleaner, or cleaning paper
containing silicon.
The lens surface could be damaged or the surface may not be completely wiped off.
• Do not clean the cover of the instrument with lens cleaner. The cover of the instrument could be
damaged.
• Never use alcohol, benzine, thinner, or other solvents to clean the cover of the instrument. This could
damage the cover of the instrument.
• Never use disinfecting ethanol, glutaraldehyde or other solvents to clean the cover of the instrument,
except the forehead rest and the chin rest. This could damage the cover of the instrument.
• If the chin rest paper will not be used, be sure to disinfect the chin rest whenever the patient is changed
in the same way as the forehead rest.
2. Notes for Using the Instrument
-3-
Environment of Use
• Do not install or store the camera or leave it standing in an adverse environment such as where the
temperature and humidity levels are high. Doing so may cause trouble and/or malfunction. Be sure to
observe the points on page (7) when selecting the installation location.
• Dust in the air will not only attach to the objective lens, but will also attach onto the optical parts inside
the instrument. You cannot take a good image when dust is on them. Please keep the room clean.
Installation
• Please ask a Canon representative or distributor to perform installation of this product.
• Please handle this product carefully. The adjustment can be altered if it is subjected to a strong shock or
jolt.
• If this product will be transported in an automobile or shipped a long distance, protective measures need
to be taken for vibrations and shocks. Ask a Canon representative or distributor for more information.
Others
For U.S.A.
Rx only-Caution:
Federal law restricts this device to sale by or on the order of a licensed practitioner.
Intended Use:
CR-1 is intended to be used for taking digital images of retina of human eye without a mydriatic.
For European Union
Intended Use:
This medical device is intended to observe image and record retinal fundus through the pupil without
contact with subject’s eye for the purpose of diagnosis by way of producing fundus image information.
-4-
3. Description
3.1 Main Unit
Symbol Name Function
a
Diopter compensation
lever
Used when the target is not brought into focus by turning the
focus knob.
b Height adjustment mark
Adjust so that the height of the patient’s eye is aligned with this
mark. This is used for adjusting the height of the chin rest.
c Focus knob Used for focusing on patient’s eye.
d Panel lighting Illuminates the operation panel (see page 6) area.
e Lift handles
To carry the camera, hold these parts at the left and right of the
main unit’s bottom panel.
fLCD monitor
Displays the anterior eye and retina observation screens as well
as various setting screen.
g Digital Camera Take fundus images (sold separately)
h Digital camera cover Covers the terminal of the digital camera.
i Shutter release button Press this button to take an image.
j Operation lever Aligns the camera with the patient’s eye.
k Operation panel 3.2 Operation Panel (see page 6)
a
b
c
d
e
k
j
i
h
g
f
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