Canon CR-2 AF User manual

Digital Retinal Camera
Instructions for Use
CR-2 AF
CR-2 Plus AF
For Euporean Union
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Important Information
• This product must only be used by a doctor or a legally qualified person.
• The user is responsible for managing the usage and maintenance of medical equipment. We
suggest that a dedicated individual is assigned responsibility for maintenance to ensure that this
product is kept in good condition and can be used safely.
• Connection of a system that uses this product to a network could result risks to patients,
operators, or third parties. A dedicated individual who is assigned responsibility for maintenance
should assess these risks in advance. The responsible person should also assess the risks when
changes to the network (including changes in the network configuration, addition or disconnection
of items to the network, or update or upgrade of equipment connected to the network) occur after
connection.
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Features
The Canon Digital Retinal Camera takes digital photographic retinal images of patient’s eyes across
an angle of view of 45 degrees.
Indications for Use
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.
Composition
• Digital Retinal Camera
• Digital camera
• Control Software
Optional products
External eye fixation lamp unit EL-1
Chin rest paper—500 sheets
1Introduction
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2Safety
Regulatory Information
CE marking
This device complies with the following:
•Regulalation (EU) 2017/745
•Directive 2011/65/EU
For European Union
Notification of Serious Incident
Any serious incident (defined in Article 2(65) of the Regulation (EU) 2017/745) that has occurred in
relation to the device should be reported to the manufacturer and the competent authority of
the Member State in which the user and/or patient is established.
Electronic Instructions for Use
Instructions for use are available on the website for viewing and download by customers.
•https://global.canon/en/ifu/medcom/index.html
For details, please contact your sales representative or local Canon dealer.
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Safety Precautions
To prevent injuries and data loss, operate this product correctly by following the safety precautions.
Do not leave alcohol, thinner, or any flammable chemicals
near the instrument.
Do not place this product 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.
Do not clean this product with flammable solvent.
For safety reasons, before cleaning this product, 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.
Otherwise, fire or electric shock may result.
Do not touch conductive parts of non-medical equipment and
the patient simultaneously.
Otherwise, electric shock may result.
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.
Do not install in locations exposed to water, steam, moisture
or dust.
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 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 this
product.
When carrying this product, be sure to tighten the stage lock, hold the carrying
indentations at the front and rear of the base panel, and keep this product 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.
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2 Safety
Ensure that the entire system conforms to IEC 60601-1-1.
Use the equipment conforming to IEC 60601-1 in the patient
environment.
Use the computer, monitor, and other equipment that conform to the system
standard IEC 60601-1 or IEC 60950-1 for this product. 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.
Make sure that the patient’s name, ID, birth date, and sex
match those that are entered for the patient.
If the entered information is incorrect, patients may be mixed up and misdiagnosed,
which may result in physical injury to the patient.
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.
If the chin rest paper is not being used, be sure to disinfect the chin rest for each
patient.
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 toward 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 this product.
Before using this product, 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 this product
is not being used.
Also, unplug the power plug from the AC outlet and put on the cover when this
product 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 while it is moving.
The main unit moves to the center position when this product main unit is turned on
or an examination is finished with the control software. Do not touch the main unit
while it is moving.
Before packing this product, return the main unit and chin
rest to their lowest 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.
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Do not turn off this product, the digital camera, or the
computer during image capture, data transfer, or backup.
Doing so might damage the computer or corrupt the data.
Do not disconnect the cable between this product and the
computer during image capture or data transfer.
Doing so might damage the computer or corrupt the data.
When you are using this product together with any equipment
that may generate power supply noise, power supply voltage
fluctuation, electromagnetic waves, or other disturbances,
check if this product works properly.
Such equipment may cause malfunctions or other trouble.
Do not change the OS settings (e.g. screen resolution, date
format, date, or language) while the control software is
running.
If changes are made while the control software is running, it may not function
properly.
Do not operate the retinal camera while operating the control
software
Otherwise, the control software may not function properly.
After taking the image of the retina, do not operate the
control software until transferring of the image is completed.
Otherwise, the control software may not function properly.
Do not turn off the computer while the control software is
running.
Be sure to exit the control software before shutting down the computer. Doing so
the measured data is not saved correctly or might corrupt the data.
On the Patient Info Edit screen, use care when editing the
patient information.
Regardless of all the essential data, input-disabled data and input format settings
which were set on the Study Input/Manual Input screen, all the data can be
changed and input.
Be sure to log off the control software when not in use.
To prevent unauthorized operation, be sure to log off the control software when it is
not being used.
Maintain and manage the operating environment of the
control software properly.
If you add, change or update the OS, driver, or other software after installing the
control software, the control software may not function properly. Contact your sales
representative or local Canon dealer beforehand.
Do not change the Windows Update settings.
Otherwise, the updates and upgrades for Windows automatically start. While
updating or upgrading Windows, the control software may operate slowly or may
not be able to operate. The control software also may not function properly after
updating or upgrading Windows.
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2 Safety
Notes on Using This Product
Digital camera
• The attached digital camera is designed for this product. 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 this product may result.
• If any problems occur or repairs are needed with this product’s digital camera, contact your sales
representative or local Canon dealer.
Before use
• Inspect this product 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 this product. 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 this product, turn off the power, cover the objective lens with the objective lens cap to
protect it from dust, and place the dust cover over this product. 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 this product with a lens cleaner. Doing so could damage the outside of
this product.
• Never use alcohol, benzine, thinner, or other solvents to clean the outside of this product. Doing so
damages the outside of this product.
• Never use disinfectant ethanol to clean the outside of this product, with the except of the forehead
rest and the chin rest. Doing so damages the outside of this product.
• 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.
• For information about lens cleaning paper, lens cleaner, and blowers, contact your sales
representative or local Canon dealer.
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Environment of use
•Use, store, and transport this product in an environment that is within the range of the following
conditions. Use the original packaging to store or ship it.
Temperature Humidity Atmospheric pressure
Environment of use 10 to 35°C 30 to 90% RH (no
condensation)
700 to 1060 hPa
Storage and transportation
environment
–30 to 50°C 10 to 95% RH (no
condensation)
600 to 1060 hPa
•Do not install, store, or leave this product in a very hot or humid environment. Also, do not use this
product outside. Doing so may cause a malfunction or misoperation.
•When this product is not being used, attach the objective lens cap and place the dust cover over
this product.
Installation
•Request your sales representative or local Canon dealer to install this product.
•A strong shock to this product 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.
•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 this product, align the stage with the base, and then lock the stage with the
stage lock lever.
•This product needs to be protected from vibration and shocks when it is transported in a vehicle
or over long distances. For details, contact your sales representative or local Canon dealer.
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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.
Only for European Union and EEA (Norway, Iceland and Liechtenstein)
This symbol indicates that this product is not to be disposed of with your
household waste, according to the WEEE Directive (2012/19/EU) and national
legislation. 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.
Symbols on the labels and their meanings.
Alternating current
Type B
Product that WEEE directive, Directive on Waste Electrical and
Electronic Equipment, requires separate collection. The directive is
effective in the European Union only.
Symbol for “Consult instructions for use”.
This symbol indicates medical device which complies with the
Regulation (EU) 2017/745
This mark shows a certification mark in European Economic Area.
Symbol for “Authorised Representative in the European Community”.
Manufacturer’s name and address
Month and year of manufacture Example: November 2014
Serial number in six digits Example: 123456
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Connecting Cables
1 Make sure that the power switch for this product is turned off.
2 Connect the power cord and the USB cable to the retinal camera.
3 Insert the power plug all the way into an AC outlet.
Preparing for an Examination
1 Turn on the computer and start the control software.
2 Remove the objective lens cap and turn the retinal camera's power switch to the ON
position.
Patient Setup
1 Start an examination on the control software.
2 Seat and position the patient.
3 Move the chin rest with the CHIN REST button so that the patient's eye is aligned with
the height adjustment mark.
4 Move the stage toward the eye to be photographed.
Alignment and Photography
1 Align the retinal camera with the eye to be photographed.
2 Tilt the operation lever forward or backward to unify the top and bottom of the image of
the pupil.
3 Have the patient stare at the internal eye fixation lamp to fix the part for the photograph.
4 Perform a preliminary check before taking photos. Control the operation lever and take
the image.
5 Check the photographed image.
Finishing an Examination
1 End the examination on control software.
2 Align the stage with the base and slide the stage lock to LOCK side to lock the stage.
Turn off the power to this product.
3 Exit the control software and turn off the computer.
Manual Focus Photography
Turn the focus ring during fundus observation. AF and AS functions will be released and the system
will switch temporarily to manual focus photography.
1 Turn the focus ring to align the split lines into a single line.
2 Perform a preliminary check before taking photos.
3 Press the shutter release button completely and take the image.
3Basic Operations
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Daily Inspections
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 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.
Checks after turning on the power
Turn on this product and start the control software. 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 adjustment button is
pressed.
3) A flash is emitted.
4) The main unit moves up and down as the main unit vertical movement ring is turned.
5) The chin rest moves up and down 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: Compensation lens released
• Focus ring: Turned clockwise more than 1 rotation.
4Maintenance
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If any of the symptoms listed here occurs or if a warning appears in the control software while using
this product, 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
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.
Err 06 Sensor cleaning is not possible.
Err 70 Photography is not possible due to an error.
5Troubleshooting
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Specifications
CR-2 AF CR-2 Plus AF
Resolution 63 lp/mm (center)
40 lp/mm (periphery)
Field angle 45°
Photographic magnification 1.1 x (image size on the sensor)
Required pupil diameter 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
Range of motion
Stage 100 mm side to side, 70 mm front to back
Main unit vertical
movement
32 mm
Chin rest range of motion 62 mm 60 mm
EMC (Electromagnetic Compatibility)
This product 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.
Warranty and Repair Service
Service life
The service life of this product is eight years if specified inspections and maintenance are performed.
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)
• Xenon lamp (only CR-2 Plus AF)
Technical Description
For the technical description, see the operation manual of the product.
Appendix
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*BT8-1756-EN01*
Manufacturer:
CANON INC.
9-1, Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa 211-8501, Japan
Telephone: [phone]
Revision Date: 2020-04
BT8-1756-EN01 0420P0.001 © CANON INC. 2020
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