Operation Manual
54 Pages
Preview
Page 1
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.
Thank you for purchasing the Canon Digital Retinal Camera CR-2 Plus AF (referred to as “CR-2 Plus AF” in this manual). The operation manuals for this instrument consist of the “Digital Retinal Camera CR-2 Plus AF Operation Manual” and the “Retinal imaging control software NM 2 Operation Manual.” Be sure to read these manuals thoroughly before using the instrument, and apply the information that you learn.
Important t The CR-2 Plus AF must only be used by a doctor or a legally qualified person. t 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 the CR-2 Plus AF is kept in good condition and can be used safely. t Rx Only (USA) Federal law restricts this device to sale by or on the order of a physician.
Disclaimers t Canon takes no responsibility for damage that occurs due to fires, earthquakes, third-party actions, other accidents, the user's deliberate misuse, negligence, experimentation, or use under other abnormal conditions. t Canon takes no responsibility for direct or consequential damages resulting from the use or the inability to use the CR-2 Plus AF. In addition, no compensation is available for lost image data, regardless of the cause of the loss of the image data. t Canon takes no responsibility for injuries or property damage that may occur if safety precautions are not followed or the instrument is used for something other than its intended purpose. t Medical examinations are the responsibility of a doctor. Canon takes no responsibility for diagnostic results. t The user is responsible for maintaining the confidentiality of image data and must follow the laws relating to the production, processing, analysis, and storage of medical images. t The information in this manual may be changed without prior notice. t Although we have made every effort to ensure the accuracy of the information in this manual, if you have any questions regarding the contents, please contact your sales representative or local Canon dealer.
Installation t Request your sales representative or local Canon dealer to install the CR-2 Plus AF.
Trademarks t Canon and the Canon logo are trademarks of Canon Inc. t Other system names and product names that appear in this manual are trademarks of their respective companies.
Copyright t The copyright of this manual belongs to Canon Inc. t Unauthorized reproduction, duplication, or reprinting of this manual in whole or in part is prohibited.
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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 ... 10 Notes on Using CR-2 Plus AF ... 14 Labels and Symbols ... 17 3 Names of Parts ... 18 Retinal Camera ... 18 Operation Panel ... 20 Observation Monitor ... 21 4 Basic Operations ... 22 Flow of Operation ... 22 Connecting Cables ... 23 Preparing for an Examination... 23 Patient Setup ... 25 Alignment and Photography ... 25 Finishing an Examination ... 30 5 Photography Auxiliary Functions ... 31 Manual Focus Photography ... 31 x2 Photography ... 32 Small Pupil Photography Function ... 33 Diopter Compensation ... 34 FAF (Fundus Autofluorescence) Photography ... 34 Anterior Segment Photography ... 35 External Monitor ... 35 6 Maintenance ... 37 Daily Inspections ... 37 Cleaning the Objective Lens ... 38 Cleaning the Image Sensor ... 39 Cleaning the Outside of the CR-2 Plus AF ... 39 Disinfecting the Forehead Rest ... 40 Refilling Chin Rest Paper ... 40 Attaching and Removing the Digital Camera ... 40 7 Troubleshooting ... 43 Appendix ... 45 Specifications ... 45 EMC (Electromagnetic Compatibility) ... 46 Warranty and Repair Service ... 51
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Introduction
Features The Canon Digital Retinal Camera CR-2 Plus AF 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 Plus AF has the following features:
AF (Auto-focus) and AS (Auto-shot) functions CR-2 Plus AF is equipped with Auto-focus and Auto-shot functions. Those provide significantly improved ease-of-operation.
A wide range of ISO speed settings The CR-2 Plus AF can take color images at a wide range of ISO speed settings from ISO 200 up to ISO 1600 as the standard flash intensity. In photography at ISO 3200/6400, applying low flash intensity mode can reduce patient discomfort caused by light glare.
Compact, user-friendly design The CR-2 Plus AF is designed to be small, lightweight, and compact. This makes it easier to assist patients. 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.
Fundus Autofluorescence Photography (FAF) photography can be performed in non-mydriatic.
Special digital camera The CR-2 Plus AF is equipped with a special digital camera using EOS digital technology. The enhanced Canon technology enables the CR-2 Plus AF to fully maximize its capabilities for shooting high-quality, high-resolution diagnostic images.
Small pupil photography function The CR-2 Plus AF 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 sent 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 CR-2 Plus AF is intended to be used for taking digital images of the retina of the human eye without a mydriatic. The CR-2 Plus AF has the following photography modes: color, red free and cobalt digital filter, and fundus autofluorecence (FAF).
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.
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1 Introduction
Checking Included Items Digital Retinal Camera CR-2 Plus AF Main unit
Digital camera cover Protects the cable that is connected to the digital camera.
Digital camera Digital camera specialized for the CR-2 Plus AF. Type: BM7-0331
Chin rest paper 100 sheets provided.
Power cord Connects the CR-2 Plus AF to an AC outlet. (3 m) USA and Canada only: Plug type: VM0275 HospitalGrade
Objective lens cap Initially covers the objective lens.
Camera mount cap Initially covers the camera mount on the retinal camera.
Body cap Initially covers the mount on the digital camera.
Dust cover Use it to cover the CR-2 Plus AF when it's not being used.
Operation Manual for the CR-2 Plus AF-this document Describes the handling precautions and operating instructions for the CR-2 Plus AF. CD-ROM-the 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 Plus AF. 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. Software License Agreement License agreement 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 unit EL-1 Chin rest paper-500 sheets
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1 Introduction
Conventions Used in This Manual Symbols to indicate safety precautions This manual uses the following symbols to indicate precautions that are important for using the CR-2 Plus AF safely. Always follow these precautions.
WARNING CAUTION CAUTION
A warning that incorrect operation may result in death or serious injury. A caution that incorrect operation may result in serious injury. A caution that incorrect operation may break the CR-2 Plus AF 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 Plus AF. This symbol indicates supplementary explanations or advice for operating the CR-2 Plus AF.
References This manual uses the following style to indicate reference destination. Example: (see page 15)
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Safety
Regulatory Information The following sections list the classifications applicable to the CR-2 Plus AF and the directives and standards that the CR-2 Plus AF complies with.
Device Classification Protection against electric shock
Class I equipment
Degree of protection against electric shock
Type B applied parts (Chin rest and forehead rest)
Degree of protection against ingress of water
IPX0
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: 2003 CAN/CSA C22.2 No.601.1-M90 IEC 60601-1: 1988+A1: 1991+A2: 1995
Medical electrical equipment – Part 1: General requirements for safety
ANSI/AAMI ES 60601-1:2005 CAN/CSA-C22.2 No.60601-1-08
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
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
IEC 60601-1-2: 2001+A1: 2004
Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-1-2: 2007
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-1-4: 1996+A1: 1999
Medical electrical equipment – Part 1-4: General requirements for safety – Collateral standard: Programmable electrical medical systems
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IEC 60601-1-6: 2010
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability
ISO 15004-1: 2006
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: 2010
Biological evaluation of medical devices – Evaluation and testing
IEC 62304: 2006
Medical device software - Software life cycle processes
IEC 62366: 2007
Medical device - Application of usability engineering to medical devices
European Union
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93/42/EEC
Medical Device Directive
EN 60601-1: 2006
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60601-1: 1990+A1: 1993+A2:1995
Medical electrical equipment – Part 1: General requirements for safety
EN 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: 2001+A1: 2006
Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests
EN 60601-1-2: 2007
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
EN 60601-1-4: 1996+A1: 1999
Medical electrical equipment – Part 1-4: General requirements for safety – Collateral standard: Programmable electrical medical systems
2 Safety EN 60601-1-6: 2010
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
EN 62304: 2006
Medical device software – Software life-cycle processes
EN 62366: 2008
Medical device – Application of usability engineering to medical devices
EN ISO 14971: 2012
Medical device – Application of risk management to medical devices
EN ISO 15004-1: 2009
Ophthalmic instruments – Part 1: General requirements applicable to all ophthalmic instruments
EN ISO 15004-2: 2007
Ophthalmic instruments – Part 2: Light hazard protection
EN ISO 10993-1: 2009 EN ISO 10993-5: 2009 EN ISO 10993-10: 2010
Biological evaluation of medical devices – Evaluation and testing
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Safety Precautions To prevent injuries and data loss, operate the CR-2 Plus AF 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. t Do not place anything heavy onto the power cord. Prohibited
t Do not damage or modify the power cord. t Do not forcibly bend, twist or pull the power cord. t Do not hold the power cord when removing it from the AC outlet. Be sure to hold the plug. t Do not use an extension cable with the power cord. Connect the power cord directly into the AC outlet. 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 socket outlet and an extension cable. Prohibited
Connect the power cord directly into the AC outlet. Do not use a multiple socket outlet and an extension cable with it.
Do not disassemble or modify. Prohibited
A disassembled or modified instrument may result in fire or electric shock. Because the CR-2 Plus AF 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. Prohibited
Do not place the CR-2 Plus AF 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.
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. t Smoke is emitted t An unusual smell t An unusual noise t Foreign matter gets inside t Devices are damaged. Fire or electric shock may result if you continue using in such condition. Immediately turn off the power of CR-2 Plus AF, 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. Prohibited
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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 Plus AF.
2 Safety
WARNING Prohibited
Do not use a power supply voltage other than that specified on the rating label. 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. Prohibited
Do not plug or unplug the power plug or handle any other parts with wet hands. Otherwise, fire or electric shock may result.
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 Plus AF with flammable solvent. Prohibited
For safety reasons, before cleaning the CR-2 Plus AF, 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.
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. Prohibited
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.
Be sure to turn off the power before moving the CR-2 Plus AF. Before moving the CR-2 Plus AF, 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. Prohibited
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.
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2 Safety
Do not install in locations exposed to water, steam, moisture or dust.
CAUTION Prohibited
Doing so may cause problems or malfunctions.
Do not install in locations exposed to salt, sulfur or corrosive gas. Prohibited
Doing so may result in corrosion of the instrument, problems or malfunctions.
Do not install in locations that are unstable or exposed to vibration. Prohibited
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. Prohibited
To make it easy to unplug the power plug at any time, avoid putting any obstructions near the AC outlet. 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
Do not place your hands or fingers on the base. Prohibited
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 Plus AF. Prohibited
When carrying the CR-2 Plus AF, 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 Plus AF 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.
Hold the CR-2 Plus AF 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 Plus AF. 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.
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2 Safety
Keep the forehead rest and chin rest clean.
CAUTION
To prevent the risk of infection, wipe the forehead rest with an ethanol solution 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. 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 Plus AF. Before using the CR-2 Plus AF, 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 Plus AF is not being used. Also, remove the power plug from the AC outlet and put on the cover when the CR-2 Plus AF 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.
CAUTION Prohibited
The main unit and the chin rest move to the center position when the CR-2 Plus AF 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.
Before packing the CR-2 Plus AF, 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 Plus AF, be sure to perform the daily inspection. Have a periodically inspection performed for the CR-2 Plus AF at least once a year by a Canon designated representative to maintain its performance and reliability.
Do not turn off the CR-2 Plus AF or the computer during image capture, data transfer, or backup. Prohibited
Doing so might damage the computer or corrupt the data.
Do not disconnect the cable between the CR-2 Plus AF and the computer during image capture or data transfer. Prohibited
Doing so might damage the computer or corrupt the data.
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Notes on Using CR-2 Plus AF Digital camera t The attached digital camera is designed for the CR-2 Plus AF. 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 Plus AF may result. t If any problems occur or repairs are needed with the CR-2 Plus AF’s digital camera, contact your sales representative or local Canon dealer.
Before use t Inspect the CR-2 Plus AF daily. Make sure that no foreign matter is present that can affect image readings or diagnoses. t Check and clean the objective lens before taking an image. Any stains or scratches on the objective lens will appear as white spots. t 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 Plus AF. In this case, wait until condensation disappears before taking images. t 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 t After using the CR-2 Plus AF, 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 Plus AF. You cannot take good images if the objective lens is dusty. t 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 t Do not allow the blower to touch the lens. t Do not wipe or rub the lens if there is dirt or dust on it. Doing so could scratch the lens. t Do not wipe the lens with an ethanol solution, eyeglass cleaner, or silicone-coated paper. Doing so could corrode the surface of the lens or leave streaks. t Do not clean the outside of the CR-2 Plus AF with a lens cleaner. Doing so could damage the outside of the CR-2 Plus AF. t Never use alcohol, benzine, thinner, or other solvents to clean the outside of the CR-2 Plus AF. Doing so damages the outside of the CR-2 Plus AF. t Never use an ethanol solution to clean the outside of the CR-2 Plus AF, with the except of the forehead rest and the chin rest. Doing so damages the outside of the CR-2 Plus AF. t 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. t Carry out all cleaning, sterilization and disinfection procedures specified in the instruction manual for each peripheral device in the system.
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2 Safety
Environment of use t Use, store, and transport the CR-2 Plus AF in an environment that is within the range of the following conditions. Use the original packaging to store or ship it. Temperature Environment of use
Humidity
Atmospheric pressure
10 to 35°C
30 to 90% RH (no condensation)
600 to 1060 hPa
Storage and transportation –30 to 50°C environment
10 to 95% RH (no condensation)
600 to 1060 hPa
t Do not install, store, or leave the CR-2 Plus AF in a very hot or humid environment. Also, do not use the CR-2 Plus AF outside. Doing so may cause a malfunction or misoperation. t 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. t When the CR-2 Plus AF is not being used, attach the objective lens cap and place the dust cover over the CR-2 Plus AF.
Installation t Request your sales representative or local Canon dealer to install the CR-2 Plus AF. t A strong shock to the CR-2 Plus AF may put it out of alignment. Please handle the unit carefully.
Transportation t Lower the main unit and chin rest to the bottom. To automatically lower them, turn on the power while holding down the set button. t Be sure to turn off the CR-2 Plus AF's power switch, remove the AC plug from the outlet, and disconnect any cables connected to other equipment. t 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. t When transporting the CR-2 Plus AF, align the stage with the base, and then lock the stage with the stage lock lever. t The CR-2 Plus AF 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.
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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
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2 Safety
Labels and Symbols The position and contents of the label attached on the CR-2 Plus AF are shown below.
The following symbols are associated with the CR-2 Plus AF. Alternating current Type B Symbol for “Consult instructions for use”.
Caution: Check the documentation provided.
Class I device indicating manufacturer’s declaration of conformance with the Annex VII of the Medical Device Directive, 93/42/EEC Certification mark that indicates the product complies with US and Canadian medical electrical system safety requirements. 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. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Manufacturer’s name and address
Month and year of manufacture
Example: November 2012
Serial number in six digits
Example: 123456
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3
Names of Parts
Retinal Camera 1 2 3 4
12
5
13
6 7 8 14
9
15 16 10
17 18
11
1 2 3 4
Digital camera Power switch for the digital camera Digital camera cover Observation monitor For viewing the anterior segment and the fundus.
5 6
Operation lever Shutter release button 1st step: Relaunching Auto fundus observation and AF 2nd step: Taking the image
7
Alignment button Switches between a view of the anterior segment and the fundus.
8
Main unit vertical movement ring Turn right: Main unit moves up. Turn left: Main unit moves down.
9
Focus ring Turn to focus the image.
10 11
18
Stage lock Indentation for lifting
12 13 14 15 16 17 18
Height adjustment mark Main unit Operation panel USB connector AC power connector Power switch for main unit Stage
3 Names of Parts
19 20 21 22 23 24
26 25
19
Connector for external eye fixation lamp (with cap)
26
Base
Connector for the external eye fixation lamp (sold separately).
20 21 22 23 24 25
Forehead rest Objective lens Objective lens cap Head rest Chin rest Indentation for lifting
19
3 Names of Parts
Operation Panel 1 6 7
2
8
3 4
9
5 10 11 1
Flash intensity button/lamp
6
+: Flash intensity increases. –: Flash intensity decreases.
2
Observation light brightness button/lamp
7 8
–: Observation light brightness decreases.
x2 photography button/lamp Enables x2 photography function. (See 32)
4
9
10
page 33)
5
CHIN REST button Top: Raises chin rest. Bottom: Lowers chin rest.
20
Set button/lamp Internal eye fixation lamp blinks (in fundus observation) / to select NEMU sections.
Small pupil photography button/lamp Enables small pupil photography function. (See
Photography mode lamp FIX TARGET/MENU Button Move up, down, right, and left to move internal eye fixation lamp (in fundus observation) / to move MENU sections.
+: Observation light brightness increases.
3
Photography mode button Switches between COLOR and FAF photography.
POWER lamp Lights when power is turned on.
11
Anterior segment photography button/lamp Switches to anterior segment photography.