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Common questions
Common Questions
20 totalWhat should I do if 5 short beeps sound and the operation panel lamps blink when I turn on the power?
Five short beeps with blinking operation panel lamps indicate that a system error has occurred. You should contact your sales representative or local Canon dealer immediately. (Page 45)
What is the minimum pupil diameter required to take images with the CR-2 AF, and what can I do if the pupil is too small?
The CR-2 AF requires a pupil diameter of 4.0 mm or greater under standard conditions. If the patient's pupil does not dilate enough, the small pupil photography function can be used, which allows imaging through pupils as small as 3.3 mm in diameter. (Page 47)
What are the correct environmental conditions for using, storing, and transporting the CR-2 AF?
During use, the CR-2 AF must be kept at a temperature of 10 to 35°C, humidity of 30 to 90% RH (no condensation), and atmospheric pressure of 700 to 1060 hPa. For storage and transportation, the acceptable ranges are –30 to 50°C, 10 to 95% RH (no condensation), and 600 to 1060 hPa. The original packaging should be used when storing or shipping the unit. (Page 14)
What should I do immediately if smoke, an unusual smell, or unusual noise comes from the CR-2 AF?
You must immediately turn off the power to the CR-2 AF and unplug the power plug, then turn off the power to all connected devices. Contact your sales representative or local Canon dealer immediately, as continuing to use the device under such conditions may result in fire or electric shock. (Page 9)
How do I disinfect the forehead rest and chin rest between patients?
The forehead rest must be wiped with disinfectant ethanol for each patient to prevent the risk of infection; no other disinfectant should be used as it may corrode the forehead rest. The chin rest paper should be replaced for each patient, and if chin rest paper is not being used, the chin rest itself must be disinfected in the same manner as the forehead rest. (Page 42)
What does it mean when Err 06 or Err 70 appears on the observation monitor?
Err 06 indicates that sensor cleaning is not possible, and Err 70 indicates that photography is not possible due to an error. Both errors indicate a malfunction detected in the digital camera; you should turn off the power to the retinal camera and then turn it on again. (Page 45)
Show 14 more questions
What is the focus adjustment range of the CR-2 AF, and what options are available for patients outside that range?
How do I prepare the CR-2 AF for long-term storage or when it will not be used for an extended period?
What should I do if the POWER lamp does not light when I turn on the CR-2 AF?
How often should I have the CR-2 AF inspected for maintenance?
What is the proper way to clean the objective lens?
How do I prepare the CR-2 AF for transportation or packing?
What should I do if flare appears in the captured image?
What is the minimum pupil diameter required to take images with the CR-2 AF?
How do I disinfect the forehead rest?
What does it mean when 5 short beeps sound and the operation panel lamps blink when I turn on the power?
How do I refill the chin rest paper?
What should I do if the split lines are not visible on the observation monitor?
Who is authorized to use the Canon CR-2 AF, and can it be purchased by anyone?
How do I clean the objective lens on the CR-2 AF?
Full Manual
55 pages
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.
Cr-2 Af
2 Thank you for purchasing the Canon Digital Retinal Camera CR-2 AF (referred to as “CR-2 AF” in this manual). The operation manuals for this instrument consist of the “Digital Retinal Camera CR-2 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 Information
3 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 AF .......................................................................... 13 Labels and Symbols.................................................................................. 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 and Photography .................................................................... 25 Finishing an Examination ......................................................................... 30 5 Photography Auxiliary Functions............................................................ 31 Manual Focus Photography...................................................................... 31 x2 Photography......................................................................................... 32 Small Pupil Photography........................................................................... 33 Diopter Compensation Photography........................................................ 34 Anterior Segment Photography................................................................ 35 External Monitor........................................................................................ 37 6 Maintenance...............................................................................................39 Daily Inspections ...................................................................................... 39 Cleaning the Objective Lens .................................................................... 40 Cleaning the Image Sensor ...................................................................... 41 Cleaning the Outside of the CR-2 AF ...................................................... 41 Disinfecting the Forehead Rest................................................................. 42 Refilling Chin Rest Paper.......................................................................... 42 Attaching and Removing the Digital Camera ........................................... 42 7 Troubleshooting.........................................................................................45 Appendix........................................................................................................ 47 Specifications ........................................................................................... 47 Patient Environment.................................................................................. 48 Operating Principle.................................................................................... 48 EMC (Electromagnetic Compatibility)....................................................... 49 Warranty and Repair Service ................................................................... 54 Contents
4 Features The Canon Digital Retinal Camera CR-2 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 AF has the following features: AF (Auto-focus) and AS (Auto-shot) functions CR-2 AF is equipped with Auto-focus and Auto-shot functions. Those provide significantly improved ease-of-operation. Reduced flash intensity The CR-2 AF can take images at ISO 400/800/1600 at the standard flash intensity, and ISO 3200/6400 in low flash intensity mode. This reduces patient discomfort caused by light glare. Special digital camera The CR-2 AF is equipped with a special digital camera using EOS digital technology. The enhanced Canon technology enables the CR-2 AF to fully maximize its capabilities for shooting high-quality, high-resolution diagnostic images. Small pupil photography function The CR-2 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 AF 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. 1 Introduction
1 Introduction 5 Checking Included Items Digital Retinal Camera CR-2
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 AF. Type: BM7-1656 Chin rest paper 100 sheets provided. Power cord Connects the CR-2 AF to an AC outlet. (3 m) USA and Canada only: Plug type: VM0275 Hospital- Grade 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 AF when it's not being used. Operation Manual for the CR-2 AF—this document Describes the handling precautions and operating instructions for the CR-2 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 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.Canon 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
6 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 AF safely. Always follow these safety precautions.
Warning
A warning that incorrect operation may result in death or serious injury.Caution
A caution that incorrect operation may result in serious injury.Caution
A caution that incorrect operation may break the CR-2 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 AF. This symbol indicates supplementary explanations or advice for operating theCr-2 Af.
References This manual uses the following style to indicate reference destination. Example: (see page 15)
7 2 Safety Regulatory Information The following sections list the classifications applicable to the CR-2 AF and the directives and standards that the CR-2 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 CanadaAnsi/Aami Es 60601-1: 2005
CAN/CSA-C22.2 No.60601-1: 08Iec 60601-1: 2005
Medical electrical equipment – Part 1: General requirements for basic safety and essential performanceIec 60601-1-2: 2001+A1: 2004
Iec 60601-1-2: 2007
Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and testsIec 60601-1-6: 2010
CAN/CSA-C22.2 No.60601-1-6: 11 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: UsabilityIso 15004-1: 2006
Ophthalmic instruments – Part 1: General requirements applicable to all ophthalmic instrumentsIso 15004-2: 2007
Ophthalmic instruments – Part 2: Light hazard protection ISO 10993-1: 2009/Cor 1: 2010Iso 10993-5: 2009
Iso 10993-10: 2010
Biological evaluation of medical devicesIec 62304: 2006
Medical device software - Software life cycle processes
8 2 Safety
Iec 62366: 2007
Can/Csa-Iec 62366: 14
Medical devices - Application of usability engineering to medical devicesIso 14971: 2007
Medical devices – Application of risk management to medical devicesIso 10940: 2009
Ophthalmic instruments – Fundus cameras European Union93/42/Eec
Medical Device DirectiveEn 60601-1: 2006+A11: 2011
Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceEn 60601-1-2: 2007
En 60601-1-2: 2001+A1: 2006
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and testsEn 60601-1-6: 2010
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: UsabilityEn 62304: 2006
Medical device software – Software life cycle processesEn 62366: 2008
Medical devices – Application of usability engineering to medical devicesEn Iso 14971: 2012
Medical devices – Application of risk management to medical devicesEn Iso 15004-1: 2009
Ophthalmic instruments – Part 1: General requirements applicable to all ophthalmic instrumentsEn Iso 15004-2: 2007
Ophthalmic instruments – Part 2: Light hazard protectionEn Iso 10993-1: 2009/Ac: 2010
En Iso 10993-5: 2009
En Iso 10993-10: 2010
Biological evaluation of medical devicesEn Iso 10940: 2009
Ophthalmic instruments – Fundus cameras
2 Safety 9 Safety Precautions To prevent injuries and data loss, operate the CR-2 AF correctly by following the safety precautions.
Warning
To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Prohibited Do not damage the power cord.
10 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. Prohibited 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. 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. Prohibited Do not clean the CR-2 AF with flammable solvent. For safety reasons, before cleaning the CR-2 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. Prohibited 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. Be sure to turn off the power before moving the CR-2 AF. Before moving the CR-2 AF, make sure that the power is turned off, the power plug is unplugged from the AC outlet, and any cables that are connected to other devices are disconnected. Prohibited 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.
2 Safety 11
Caution
Prohibited Do not install in locations exposed to water, steam, moisture or dust. Doing so may cause problems or malfunctions. Prohibited Do not install in locations exposed to salt, sulfur or corrosive gas. Doing so may result in corrosion of the instrument, problems or malfunctions. Prohibited 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. Prohibited 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. Fire or electric shock may result if the power plug is not unplugged during an emergency. Prohibited 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. 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. Prohibited Do not hold the head rest or digital camera when moving theCr-2 Af.
When carrying the CR-2 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 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 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 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 the Digital Retinal Camera CR-2 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. For details on the patient environment, see “Patient Environment” (see page 48). Otherwise, electric shock may occur. For details, please contact your sales representative or local Canon dealer.
12 2 Safety
Caution
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. 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 the CR-2 AF. Before using the CR-2 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 AF is not being used. Also, unplug the power plug from the AC outlet and put on the cover when the CR-2 AF is not going to be used for a long time. Otherwise, dust or any foreign matter may accumulate and result in fire.Caution
Prohibited Do not touch the main unit while it is moving. The main unit moves to the center position when the CR-2 AF 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 the CR-2 AF, 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. Inspect daily and periodically. For safety reasons, before using the CR-2 AF, be sure to perform the daily inspection. Have a periodically inspection performed for the CR-2 AF at least once a year by a Canon designated representative to maintain its performance and reliability. Prohibited Do not turn off the CR-2 AF, the digital camera, or the computer during image capture, data transfer, or backup. Doing so might damage the computer or corrupt the data. Prohibited Do not disconnect the cable between the CR-2 AF and the computer during image capture or data transfer. Doing so might damage the computer or corrupt the data.
2 Safety 13 Notes on Using CR-2 AF Digital camera
14 2 Safety Environment of use
2 Safety 15 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.
16 2 Safety Labels and Symbols The position and contents of the label attached on the CR-2 AF are shown below. The following symbols are associated with the CR-2 AF. Alternating current Type B Product that WEEE directive, Directive on Waste Electrical and Electronic Equipment, 2012/19/EU, requires separate collection. The directive is effective in the European Union only. 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. 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 2014 Serial number in six digits Example: 123456
17 Retinal Camera 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 1 Digital camera 2 Power switch for the digital camera 3 Digital camera cover 4 Observation monitor For viewing the anterior segment and the fundus. 5 Operation lever 6 Shutter release button 1st step: Relaunching Auto fundus observation and AF/AS functions 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 Stage lock 11 Indentation for lifting 12 Height adjustment mark 13 Main unit 14 Operation panel 15 USB connector 16 AC power connector 17 Power switch for main unit 18 Stage 3 Names of Parts
18 3 Names of Parts 19 20 21 23 22 25 24 26 19 Connector for external eye fixation lamp (with cap) The external eye fixation lamp is sold separately. 20 Forehead rest 21 Objective lens 22 Objective lens cap 23 Head rest 24 Chin rest 25 Indentation for lifting 26 Base
3 Names of Parts 19 Operation Panel 7 3 1 5 4 2 10 9 8 6 11 1 Flash intensity adjustment button/lamp +: Flash intensity increases. –: Flash intensity decreases. 2 Observation light brightness adjustment button/lamp +: Observation light brightness increases. –: Observation light brightness decreases. 3 x2 photography button/lamp Enables x2 photography function. (See page 32) 4 Small pupil photography button/lamp Enables small pupil photography function. (See page 33) 5 CHIN REST button Top: Raises chin rest. Bottom: Lowers chin rest. 6 Diopter compensation button Enables diopter compensation photography function. (See page 34) 7 Diopter compensation mode lamp No lamp lights: No diopter compensation + lamp lights: Positive compensation – lamp lights: Negative compensation 8 FIX TARGET/MENU button Move up, down, right, and left to move internal eye fixation lamp (in fundus observation)/to move MENU sections. 9 SET button/lamp Internal eye fixation lamp blinks (in fundus observation) / to select MENU sections. 10 POWER lamp Lights when power is turned on. 11 Anterior segment photography button/lamp Enables anterior segment photography function. (See page 35)
20 3 Names of Parts Observation Monitor During anterior segment observation (with x1.3 magnification)
On
On
1 2 3 4 5 6 7 8 1 Auto fundus observation indicator 2 Photography mode indicator COLOR: Color photography mode ANT.IR: Infrared photography mode for anterior segment 3 Pupil alignment circles 4 Observation light brightness indicator 5 Photography ready lamp Green: Ready to shoot Red: Not ready to shoot 6 Left/right eye indicator R: Right eye L: Left eye 7 Anterior segment photography indicator 8 Flash intensity indicator During fundus observation (with x1.3 magnification) 1 3 4 5 6 7 8 9 10 11 12 2 13 1 Indicator for top limit of position of main unit Appears when main unit has reached top limit. 2 Focus indicator 3 Continuous photography indicator Fundus observation does not return to anterior segment after photography. 4 AS (Auto-shot) guide (green) 5 Internal eye fixation lamp position indicator 6 x2 photography indicator 7 Small pupil photography indicator 8 AF (Auto-focus) indicator 9 AS (Auto-shot) indicator 10 Diopter compensation indicator None: No diopter compensation +: Positive compensation –: Negative compensation 11 Small pupil photography range 12 x2 photography range 13 Indicator for bottom limit of position of main unit Appears when main unit has reached bottom limit.
21 Flow of Operation The flow of operation 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 and Photography (page 25) x2 Photography (page 32) Small Pupil Photography (page 33) Diopter Compensation Photography (page 34) Anterior Segment Photography (page 35) Finishing an Examination (page 30) Manual Focus Photography (page 31) 4 Basic Operations
22 4 Basic Operations Connecting Cables Connect the CR-2 AF to a computer in which the supplied software, Rics NM 2 has been installed.
Warning
Caution
4 Basic Operations 23 3 Remove the objective lens cap and turn the retinal camera's power switch to the ON position. The POWER lamp lights and the SET lamp blinks. The CR-2 AF automatically starts an initialization sequence (internal check and initialization of driving parts). After the initialization, the parts of the main unit stop in their center positions.
Caution
The main unit moves to the center position when the CR-2 AF is turned on. Do not touch the main unit while it is moving. 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 or move the stage right or left. 4 Press and hold the unlock button and slide the stage lock to the UNLOCK side. Align the mark on the stage lock and the mark on the left side of the base. The stage lock is released. 5 Move the stage toward you with the operation lever. 6 Disinfect the forehead rest and replace the chin rest paper. If chin rest paper is not being used, disinfect the chin rest also.Caution
24 4 Basic Operations Patient Setup 1 Start an examination on the Rics NM 2. Enter the patient’s information. The SET lamp lights and the observation monitor turns on. 2 Seat and position the patient.
Caution
4 Basic Operations 25 Alignment and Photography This section describes the standard procedures for taking images using Auto fundus observation, AF (Auto-focus), and AS (Auto-shot) functions. 1 Align the retinal camera with the eye to be photographed.
Caution
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.
26 4 Basic Operations When the top and the bottom of the image of the pupil are unified, the anterior segment automatically switches to the fundus on the observation monitor.
On
On
Auto Fundus Observation Indicator Displayed when Auto fundus observation function is available. Icon colors indicate the status of the detecting pupil. Total color of icon is dark gray: Error in the detecting pupil.Indication bar is totally dark gray: The detecting pupil is impossible.
The left side of indication bar is green: The position of the detecting pupil is not effective.
Indication bar is totally green: The position of the detecting pupil is effective. Anterior segment observation can be switched to fundus observation manually by pressing the alignment button. 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 33). Adjustment of observation light brightness Adjust the observation light brightness with the observation light brightness adjustment 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.
4 Basic Operations 27 3 Have the patient stare at the internal eye fixation lamp to fix the part for the photograph. 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. 4 Perform a preliminary check before taking photos. a. The photography ready lamp lights green. b. The working distance dots appear. c. The focus indicator appears.
On
On
Af
a b c Photography ready lamp
28 4 Basic Operations 5 Control the operation lever and take the image. AF function aligns split lines into a single line. Adjust the operation lever to make the working distance dots sharp and put both dots into the Auto-shot guide square.
On
On
Af
The flash fires and an image is taken. AF (Auto-focus) Indicator Displayed when AF function is available. Icon colors indicate AF status.The right side of indication bar is red: AF error
The left side of indication bar is green: AF in operation
Indication bar is totally green: AF completed AS (Auto-shot) Indicator Displayed when AS function is available. Icon colors indicate AS status.
Indication bar is totally dark gray: Error in detecting WD.
The right side of indication bar is red/orange: The position or the shape of WD is not effective.
The left side of indication bar is green: AS is in preparation.
Indication bar is totally green: AS is ready. Although the AS icon indicates the preparation status, it may be possible to take an image. Turn the focus ring to release AF function and manual focus photography can be performed (see page 31). AS function is not available for manual focus photography. If AF or AS function does not work, please refer to “7 Troubleshooting” (see page 45) and follow the instructions. If the diopter of the patient’s eye is outside the focus adjustment range, the photography mode is automatically switched to the diopter compensation photography (see page 34).
4 Basic Operations 29 6 Check the photographed image. The preview is displayed on the observation monitor. Press the SET button to save the image. The image is saved and the preview is closed. If any selection is made on this screen, the image taken is saved automatically and the preview is closed. If the image will be retaken, press the button to activate “Retake” and press the SET button. The preview is closed and returns to the anterior segment observation. To take images of the other eye, repeat procedures from step 1 of “Alignment and Photography” (see page 25).
Ok
RetakeFix Target
/Menu
SET button This preview screen is displayed in approximately 3 seconds. Use the Rics NM2 to change display time. Auto fundus observation function will be temporarily released after photography. To relaunch the function, press the shutter release button halfway until a beep sounds. 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. See “7 Troubleshooting” (see page 45) and follow the instructions.
30 4 Basic Operations Finishing an Examination 1 End the examination on Rics NM 2. The SET lamp starts blinking and the observation monitor turns off.
Caution
The main unit moves to the center position when an examination is finished with the Rics NM 2. Do not touch the main unit while it is moving. 2 Align the stage with the base and slide the stage lock to LOCK side to lock the stage. Align the mark on the stage lock and the mark on the right side of the base. 3 Turn off the power to the CR-2 AF. 4 Exit the Rics NM 2 and turn off the computer.
31 The section describes how to use manual focus photography, x2 photography, small pupil photography, diopter compensation photography, and anterior segment photography. Instructions are also included for connecting an optional external monitor. 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. Press the shutter release button halfway until a beep sounds: this indicates that AF and AS functions are available. Shutter Release Button The shutter release button has two steps. The first step is to press the button halfway down; the second step is to press the button all the way down. 1 Turn the focus ring to align the split lines into a single line. The image enlarges while the focus ring is being turned.
-1.25D
Focus ring Split line Correct Incorrect Incorrect When the split lines do not align If the diopter of the patient’s eye is outside the range of -10 to +15 D, it is not possible to focus with the focus indicator. In this case, use the diopter compensation photography function (see page 34). 2 Perform a preliminary check before taking photos. a. The photography ready lamp lights green. b. The working distance dots appear sharpest. c. The working distance dots are inside the AS guide. d. The split lines form a single line.On
On
b,c d a 5 Photography Auxiliary Functions
32 5 Photography Auxiliary Functions 3 Press the shutter release button completely and take the image. The flash fires and an image is taken. The preview is displayed on the observation monitor. x2 Photography You can take and save images that are within the x2 photography range on the observation monitor. 1 Press the x2 photography button. The lamp on the x2 photography button lights, and the x2 photography indicator and the x2 photography range marks appear on the observation monitor. x2 photography indicator x2 photography range mark
On
On
2 Perform “Alignment and Photography” in the same manner as for basic operations. x2 photography can be performed in the same manner as for “Alignment and Photography” (see page 25). The image in the x2 photography range appears on the Rics NM 2 screen.
5 Photography Auxiliary Functions 33 Small Pupil Photography 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. 1 Press the small pupil photography button. The lamp on the small pupil photography button lights, and the small pupil photography indicator and the small pupil photography range mark appear on the observation monitor.
On
On
Small pupil photography indicator Small pupil photography range mark 2 Perform “Alignment and Photography” in the same manner as for basic operations. Small pupil photography can be performed in the same manner as for “Alignment and Photography” (see page 25). Press the small pupil photography button again to finish the small pupil photography.
34 5 Photography Auxiliary Functions Diopter Compensation Photography If the diopter of the patient’s eye is outside the range which is able to be adjusted by the focus indicator, the photography mode is automatically switched to the diopter compensation photography. The CR-2 AF can provide appropriate images if the diopter of the patient’s eye is within the respective ranges below.
On
On
Diopter compensation indicator 1 Turn the focus ring to focus on the retinal image. Once the diopter compensation mode is enabled, one of the diopter compensation mode lamps lights and the diopter compensation indicator appears on the observation monitor. The focus indicator is not available in the diopter compensation mode. Turn the focus ring and focus on the retinal image until you can see it sharply on the observation monitor.On
On
Diopter compensation indicator Diopter compensation mode lamp
5 Photography Auxiliary Functions 35 2 Perform a preliminary check before taking photos. a. The photography ready lamp lights green. b. The working distance dots are inside the AS guide.
On
On
b a 3 Press the shutter release button completely and take the image. The flash fires and an image is taken. The preview is displayed on the observation monitor. Anterior Segment Photography This function enables you to photograph the anterior segment in color and infrared. It is also possible to use the x2 photography function at the same time. The settings on the Rics NM 2 are required before you photograph the anterior segment in infrared. For details, contact your sales representative or local Canon dealer. Do not allow external light in the infrared spectrum to enter the position being photographed. AF and AS functions are not available in the anterior segment photography. 1 Press the anterior segment photography button. The lamp on the anterior segment photography button lights, and the anterior segment photography indicator appears on the observation monitor. Anterior segment photography indicator Photography mode indicator
36 5 Photography Auxiliary Functions The photography mode can be switched in the following order by pressing the anterior segment photography button. Photography mode Color retinal: Color anterior segment: Infrared anterior segment: Observation monitor 2 Move the stage toward you to the position where it stops. 3 Slide the stage from side to side to align the area to be photographed in the center of the observation monitor. 4 Tilt the operation lever to the front or back to focus on the area to be photographed. 5 Perform a preliminary check before taking photos. a. The photography ready lamp lights green. a 6 Press the shutter release button completely and take the image. The flash fires and an image is taken. The preview is displayed on the observation monitor.
5 Photography Auxiliary Functions 37 External Monitor The image on the observation monitor can be viewed on an external monitor. Contact your sales representative or local Canon dealer about external monitors and mini HDMI cables that can be used.
38 5 Photography Auxiliary Functions 4 Connect the HDMI cable to the external monitor. Connect the HDMI cable to the HDMI input terminal on the external monitor. Turn on the external monitor, and select the input using the monitor’s input switch. 5 Start the Rics NM 2 and configure the settings to output to the external monitor. See the Rics NM 2 manual for details about the settings. 6 Turn on the power to the retinal camera. The image is displayed on the external observation monitor. No image is displayed on the observation monitor of the retinal camera.
39 This section outlines the maintenance instructions for the CR-2 AF: daily inspection, cleaning, disinfecting, refilling chin rest paper, and removing/installing the digital camera.
Caution
Standard
Compensation lens released
Turned clockwise more than 1 rotation. 6 Maintenance
40 6 Maintenance Cleaning the Objective Lens
6 Maintenance 41 Cleaning the Image Sensor The digital camera has a self-cleaning sensor unit. 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. 1 When the CR-2 AF is in operation, end the examination on Rics NM 2. 2 Turn off the power to the CR-2 AF, then turn on the power again. The self-cleaning sensor unit operates to remove the dust on the image sensor during initialization of the retinal camera. 3 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 AF
Warning
42 6 Maintenance Disinfecting the Forehead Rest
Caution
Caution
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, see the Disinfecting Forehead Rest section above. 1 Pull out the right and left chin rest holding pins. 2 Insert the holding pins into the holes on the right and left of the chin rest paper. 3 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 AF 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. Although not recommended, if you need to remove and attach the digital camera, take the following precautions.
6 Maintenance 43 Removing the digital camera 1 Turn off the power to the retinal camera and unplug the plug from the AC outlet. 2 Loosen the cover screw and remove the digital camera cover. 3 Remove the cables from the digital terminal and the remote control terminal. 4 Remove the DC coupler.
44 6 Maintenance Installing the digital camera 1 Be sure to check the following items:
45 If any of the symptoms listed here occurs or if a warning appears in the Rics NM 2 while using the CR-2 AF, 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 lamp does not light when the power is turned on. The power cord has been disconnected. Turn off the power to the retinal camera and reconnect the power cord. 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. Nothing appears on the observation monitor. Turn on the digital camera. The retinal camera is connected to the external monitor. The observation monitor is not available in this case. 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 Sensor cleaning is not possible. Err 70 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 visible. The retinal camera and the eye are not aligned. Align them correctly. AF or AS function does not work. The patient has an abnormal cornea or cataract or other diseases. Take images using manual focus photography (see page 31). The patient has a small pupil. Take images using small pupil photography (see page 33). Flare appears in the image. 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. 1) White flare appears around the edges of the image. The retinal camera and the patient’s eye are separated. Move the objective lens closer to the patient’s eye. 2) Orange flare appears around the edges of the image. The retinal camera and the patient’s eye are too close. Move the objective lens away from the patient’s eye. 3) 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. 4) 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. 7 Troubleshooting
46 7 Troubleshooting Symptom Cause and remedy The split lines are not visible. 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 (see page 33). Eyebrows or eyelashes are blocking the pupil. Instruct the patient to open his/her eye wider. The patient's eye is opacity. Focusing cannot be performed with the split lines. The diopter compensation lens is inserted. Press the diopter compensation button to be no diopter compensation. The split line lamps are not lit. The split lines do not align. The diopter of the patient’s eye is outside the range of –10 to
+15D.
Use the diopter compensation function, turn the focus ring, and focus on the position where the images of the retina look clear. Cannot capture good images. 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 (see page 33). 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. The patient's eye is opacity. Clear images cannot be captured if this is the case. Adjust the flash intensity, the diopter compensation, or the small pupil photography function. The objective lens is dirty. Clean the objective lens (see page 40). The patient is wearing contact lenses. Instruct the patient to remove his/her contact lenses. Black spots or any artifacts appear in the same place in every captured image. There is dirt or dust on the objective lens. Clean the objective lens (see page 40). Dirt or dust is stuck to the image sensor of the digital camera. Use the self-cleaning sensor unit to clean it (see page 41). White spots are visible on the captured image. The objective lens is dirty. Clean the objective lens (see page 40). The patient's eyelashes are interfering with the image. Instruct the patient to open his/her eye wider, then capture another image. No observed or previewed images are displayed properly on the external monitor. Configure the settings to output to the external monitor on the Rics NM 2. Use a monitor having a full high definition (1920 x 1080) resolution. For details, please contact your sales representative or local Canon dealer.
47 Specifications 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)
Observation light source Infrared LED
Flash source White LED, Infrared 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
Main unit vertical movement 32 mm Chin rest range of motion 62 mm Power supply rating AC 100 to 240 V, 50/60 Hz, 1 to 0.4 A Dimensions 305 (W) × 500 (D) × 473 (H) mm Weight Approximately 15 kg (including 0.8 kg digital camera)
Appendix
48 Appendix Patient Environment The patient environment where the patient/examiner may contact the equipment (including the connected devices) or where the patient/examiner may contact the person who touches the equipment (including the connected devices) is illustrated below. Radius 1.5 m 1.5 m 1.5 m 2.5 m Operating Principle The CR-2 AF takes a retinal image without making contact with the patient’s eye. Other devices, such as printers, are needed to output the image.
Appendix 49 EMC (Electromagnetic Compatibility) The CR-2 AF 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 AF 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:
50 Appendix Guidance and Manufacturer’s Declaration for Electromagnetic Emission The CR-2 AF is intended for use in the electromagnetic environment specified below. The customer or the user of the CR-2 AF should assure that it is used in such an environment. Emission Test Compliance Electromagnetic Environment – Guidance RF emissions
En 55011
Cispr11
Group 1 The CR-2 AF 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 emissionsEn 55011
Cispr11
Class B The CR-2 AF 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 emissionsEn Iec 61000-3-2
Class A Voltage fluctuations/flicker emissionsEn Iec 61000-3-3*
Complies
Appendix 51 Guidance and Manufacturer’s Declaration for Electromagnetic Immunity The CR-2 AF is intended for use in the electromagnetic environment specified below. The customer or the user of the CR-2 AF should assure that it is used in such an environment. Immunity Test
Iec 60601
Test Level Compliance Level Electromagnetic Environment – Guidance Electrostatic discharge(Esd)
En 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/ burstEn 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. SurgeEn 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 linesEn Iec 61000-4-11
<5% UT (>95% dip in UT) for 0.5 cycles 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec <5% UT (>95% dip in UT) for 0.5 cycles 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec Mains power quality should be that of a typical commercial or hospital environment. If the user of the CR-2 AF requires continued operation during power mains interruptions, it is recommended that the CR-2 AF be powered from an uninterruptible power supply. Power frequency (50/60 Hz) magnetic fieldEn 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:
UT is the a.c. mains voltage prior to application of the test level.
52 Appendix Guidance and Manufacturer’s Declaration for Electromagnetic Immunity The CR-2 AF is intended for use in the electromagnetic environment specified below. The customer or the user of the CR-2 AF should assure that it is used in such an environment. Immunity Test
Iec 60601
Test Level Compliance Level Electromagnetic Environment – Guidance Conducted RFEn Iec 61000-4-6
Radiated RFEn 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-2 AF, 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 Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). 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 AF is used exceeds the applicable RF compliance level above, the CR-2 AF 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 AF. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Appendix 53 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and Devices or the CR-2 AF The CR-2 AF is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CR-2 AF can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CR-2 AF 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 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 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 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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.
54 Appendix Warranty and Repair Service Service life The service life of this product is eight years if specified inspections and maintenance are performed. About repairs If a problem cannot be solved even after taking the measures indicated in “7 Troubleshooting” (see page 45), 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 AF 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 AF 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.
Manufacturer: 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. Canon Specialised Imaging Division Building A, The Park Estate, 5 Talavera Road, Macquarie Park, N.S.W. 2113, Australia Telephone: (61)-2-9805-2000