Canon CR-2 PLUS AF User Manual

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.

Page 2

Important

Disclaimers

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.

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.

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.

Installation

Trademarks

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.

t Request your sales representative or local Canon dealer to install the CR-2 Plus AF.

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.

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.

Page 3

Contents

1 Introduction ................................................................................................. 4

2 Safety ........................................................................................................... 7

3 Names of Parts ......................................................................................... 18

4 Basic Operations ...................................................................................... 22

Features ...................................................................................................... 4

Indications for Use ..................................................................................... 4

Checking Included Items .......................................................................... 5

Conventions Used in This Manual ............................................................ 6

Regulatory Information ............................................................................... 7

Safety Precautions ................................................................................... 10

Notes on Using CR-2 Plus AF ................................................................. 14

Labels and Symbols ................................................................................. 17

Retinal Camera ........................................................................................ 18

Operation Panel ....................................................................................... 20

Observation Monitor ................................................................................ 21

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

Appe ndix ....................................................................................................... 45

Specifications ..........................................................................................45

EMC (Electromagnetic Compatibilit y) ...................................................... 46

Warranty and Repair Service .................................................................. 51

Page 4

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.

Page 5

Checking Included Items

1 Introduction

Digital Retinal Camera CR-2 Plus AF

Main unit

Digital camera

Digital camera specialized for the CR-2 Plus AF. Type: BM7-0331

Power cord

Connects the CR-2 Plus AF to an AC outlet. (3 m) USA and Canada only: Plug type: VM0275 Hospital-

Grade

Camera mount cap

Initially covers the camera mount on the retinal camera.

Digital camera cover

Protects the cable that is connected to the digital camera.

Chin rest paper

100 sheets provided.

Objective lens cap

Initially covers the objective lens.

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

Page 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 Plus AF safely. Always follow these precautions.

WARNING

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)

Page 7

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

Degree of protection against ingress of water IPX0

and forehead rest)

Degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide

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+A 2: 199 5

ANSI/AAMI ES 60601-1:2005 CAN/CSA-C22.2 No.60601-1-08

IEC 60601-1: 2005

IEC 60601-1-1: 2000 Medical electrical equipment – Part 1-1: General

Not suitable

Medical electrical equipment – Part 1: General requirements for safety

Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

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

Page 8

2 Safety

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 109 93-10: 2010

IEC 62304: 2006 Medical device software - Software life cycle processes

IEC 62366: 2007 Medical device - Application of usability engineering to

Biological evaluation of medical devices – Evaluation and testing

medical devices

European Union

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

Page 9

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

Page 10

2 Safety

Safety Precautions

To prevent injuries and data loss, operate the CR-2 Plus AF correctly by following the safety precautions.

WARNING

Prohibited

To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

Do not damage the power cord.

t Do not place anything heavy onto the power cord.

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.

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.

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.

Prohibited

Do not leave alcohol, thinner, or any flammable chemicals near the instrument.

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.

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.

Page 11

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.

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.

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.

Prohibited

Turn off the power before inspection.

For safety reasons, before inspecting the instrument or cables, be sure to turn off the power of all the devices. Otherwise, electric shock may result.

Do not play the supplied CD-ROM in any CD player that does not support data CD-ROMs.

Playing the CD-ROM in an audio CD player may damage the speaker. Playing the CD-ROM in an audio CD player may also cause hearing loss if listened to with headphones.

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.

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.

Page 12

2 Safety

CAUTION

Prohibited

Do not install in locations exposed to water, steam, moisture or dust.

Doing so may cause problems or malfunctions.

Do not install in locations exposed to salt, sulfur or corrosive gas.

Doing so may result in corrosion of the instrument, problems or malfunctions.

Do not install in locations that are unstable or exposed to vibration.

The vibration may knock over the instrument or the instrument may become unbalanced and fall, resulting in a malfunction or injury.

Do not place 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.

Do not block the vent holes.

Doing so may cause the internal temperature to rise and result in fire.

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 the CR-2 Plus AF.

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.

Page 13

2 Safety

CAUTION

Keep the forehead rest and chin rest clean.

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.

CAUTION

Prohibited

Do not touch the main unit or the chin rest while they are moving.

The main unit and the chin rest move to the center position when the CR-2 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.

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.

Doing so might damage the computer or corrupt the data.

Page 14

2 Safety

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.

Page 15

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.

Environment of use 10 to 35°C 30 to 90% RH (no

Storage and transportation environment

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.

2 Safety

Temperature Humidity Atmospheric pressure

600 to 1060 hPa

condensation)

–30 to 50°C 10 to 95% RH (no

condensation)

600 to 1060 hPa

Transportation

t A strong shock to the CR-2 Plus AF may put it out of alignment. Please handle the unit carefully.

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.

Page 16

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

Page 17

Labels and Symbols

The position and contents of the label attached on the CR-2 Plus AF are shown below.

2 Safety

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

Page 18

Names of Parts

Retinal Camera

1 2

3 4

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

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

Page 19

3 Names of Parts

19 Connector for external eye fixation lamp

(with cap)

Connector for the external eye fixation lamp (sold separately).

20 Forehead rest 21 Objective lens 22 Objective lens cap 23 Head rest 24 Chin re st 25 Indentation for lifting

26 Base

Page 20

3 Names of Parts

Operation Panel

1 Flash intensity button/lamp

+: Flash intensity increases.

–: Flash intensity decreases.

2 Observation light brightness button/lamp

+: Observation light brightness increases.

–: Observation light brightness decreases.

3 x2 photography button/lamp

Enables x2 photography function. (See 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 Photography mode button

Switches between COLOR and FAF photography.

7 Photography mode lamp 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 NEMU sections.

10 POWER lamp

Lights when power is turned on.

11 Anterior segment photography button/lamp

Switches to anterior segment photography.

Page 21

Observation Monitor

During anterior segment observation (with x1.3 magnification)

3 Names of Parts

1 Auto fundus observation indicator 2 Photography mode indicator

COLOR: Color photography mode

FAF: Fundus autofluorescence photography mode

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)

3 4

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 position 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.

8 9

Page 22

Basic Operations

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 23).

Preparing for an Examination (page 23)

Patient Setup (page 25)

Alignment and Photography (page 25)

Manual Focus Photography (page 31)

x2 Photography (page 32)

Small Pupil Photography Function (page 33)

Diopter Compensation (page 34)

FAF (Fundus Autofluorescence) Photography (page 34)

Anterior Segment Photography (page 35)

Finishing an Examination (page 30)

Page 23

Connecting Cables

Connect the CR-2 Plus AF to a computer in which the supplied software, Rics NM 2 has been installed.

4 Basic Operations

WARNING

t Do not plug or unplug the power plug with wet hands.

t Do not use any power cord other than the one supplied.

Otherwise, fire or electric shock may result.

Make sure that the power switch for the CR-2 Plus AF is turned off.

Connect the power cord and the USB cable to the

retinal camera.

Insert the power plug all the way into an AC outlet.

Connect the other end of the USB cable to the computer’s USB port.

Use a high-speed AB type USB cable that is shorter than three meters. For details, contact your sales representative or local Canon dealer.

Preparing for an Examination

CAUTION

t To prevent the risk of infection, wipe the forehead rest with an ethanol solution for each patient.

For details on how to disinfect, consult a specialist.

t To ensure cleanliness, replace the chin rest paper for each patient.

Turn on the computer and start the Rics NM 2.

If the digital camera is off, turn the switch to the ON.

If the Mode Dial is set to anything other than , an image cannot be taken. While holding down the button at the center of the Mode Dial, turn the dial to

Page 24

4 Basic Operations

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 Plus AF automatically does an initialization sequence (internal check and initialization of driving parts). After the initialization the parts of the main unit stop in their center positions.

CAUTION

The main unit and the chin rest move to the center position when the CR-2 Plus AF is turned on. Do not touch the main unit or the chin rest while they are moving. Keep the patient’s chin away from the main unit and chin rest when they are moving.

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.

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.

Move the stage towards you with the operation lever.

CAUTION

Disinfect the forehead rest and replace the chin rest paper.

If chin rest paper is not being used, disinfect the chin rest also.

t To prevent the risk of infection, wipe the forehead rest with an ethanol solution for each patient.

For details on how to disinfect, consult a specialist.

t To ensure cleanliness, replace the chin rest paper for each patient.

Page 25

Patient Setup

4 Basic Operations

Start an examination on the Rics NM 2.

Enter the patient’s information. The set lamp lights and the observation monitor turns on.

Seat and position the patient.

t Instruct the patient to remove his/her contact lenses or glasses, if he/she is wearing them.

t Have the patient place his/her chin on the chin rest and his/her forehead against the forehead rest.

Adjust the heights of the optical bench and chair so the patient is comfortable.

Move the chin rest with the CHIN REST button so that the patient's eye is aligned with the height adjustment mark.

Height adjustment mark

Chin rest rises

Chin rest lowers

Move the stage toward the eye to be photographed.

CAUTION

t Do not place your hands or fingers on the base.

t Instruct the patient not to place his/her hands or fingers on the base.

Otherwise, your or the patient’s hands or fingers may be pinched, possibly resulting in injury.

Hold the operation lever, pull it toward you, and then move the stage.

Alignment and Photography

This section describes the standard procedures for taking images using Auto-fundus observation, AF (Auto-focus), and AS (Auto-shot) functions.

CAUTION

Align the retinal camera with the eye to be photographed.

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.

Page 26

4 Basic Operations

1. Move the stage until the eye to be photographed appears on the observation monitor.

2. Adjust the center of the patient's pupil and the pupil alignment circles.

3. Have the patient stare at the green blinking internal eye fixation lamp.

Pupil alignment circles

During examination of the anterior segment of a patient who is extremely near- or far-sighted, the patient may not be able to see the internal eye fixation lamp.

t To move the main unit slightly to the left or right, tilt the

operation lever to the left or right.

t To move the main unit slightly to the front or back, tilt the

operation lever to the front or back.

t To move the main unit up or down, turn the main unit

vertical movement ring.

When the ver tical position cannot be fully adjusted by using the operation lever

Adjust the height of the chin rest with the CHIN REST button to raise or lower the patient's face.

Tilt the operation lever forward or backward to unify the top and bottom of the image of

the pupil.

Page 27

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.

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.

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 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.

Page 28

4 Basic Operations

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.

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.

㻭㻲

Photography ready lamp

t Green: Ready to shoot.

t Red: Preparing to shoot. Wait until the lamp lights green.

Flash intensity adjustment

The flash intensity is set JOBEWBODFto the standard level. Every time the flash intensity button is pressed the flash intensity increases by 0.3 stop.

Appearance of flare

Even if the working distance dots are adjusted to be extremely clear, flare may appear around the retinal image depending on the patient’s eye.

Page 29

4 Basic Operations

Control the operation lever and take the image.

The Auto-focus 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.

㻭㻲

The flash fires and an image is taken.

AF (Auto-focus) Indicator

Displayed when AF (Auto-focus) 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 (Auto-shot) 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 and manual focus shooting can be done. AS function is not available for manual focus shooting.

If AF or AS does not work, please refer to “7 Troubleshooting” (see page 43) and follow the instructions.

Page 30

4 Basic Operations

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 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).

button to activate “Retake” and press the SET button. The

FIX TARGET

/MENU

SET

This preview screen is displayed in approximately 3 seconds. Use the Rics NM2 to change display time.

Auto-fundus observation function will be temporarily unavailable after photography. To relaunch the function, press the shutter release button halfway until a beep sounds.

If flare appears

See “7 Troubleshooting” (see page 43) and follow the instructions.

Finishing an Examination

End the examination on Rics NM 2.

The set lamp starts blinking and the observation monitor turns off.

Retake

CAUTION

The main unit and the chin rest move to the center position when a study is finished with the Rics NM 2. Do not touch the main unit or chin rest while they are moving.

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.

Turn off the power to the CR-2 Plus AF.

Exit the Rics NM 2 and turn off the computer.

Page 31

Photography Auxiliary Functions

The section describes how to use manual focus photography, x2 photography, small pupil photography, diopter compensation, FAF (Fundus Autofluorescence) 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. Auto-focus (AF) and Auto-shot (AS) functions will be suspended 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 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.

Turn the focus ring to align the split lines into a single line.

The image enlarges while the focus ring is being turned.

Split line

Correct

Incorrect

Focus ring

When the split lines do not align

If the patient’s diopter range is outside the –10 to +15 D, it is not possible to focus with the focus indicator. In this case, use the diopter compensation function (see page 34), and focus the image until it is sharp.

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.

b,c

Page 32

5 Photography Auxiliary Functions

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.

Press the x2 photography button.

The lamp on the x2 photography button lights, and the x2 photography indicator and x2 photography range marks appear on the observation monitor.

x2 photography range mark

x2 photography indicator

Perform alignment and photography in the same manner as for basic operations.

x2 photography can be performed in the same manner as for color photography (see page 25). The image in the x2 photography range appears on the Rics NM 2 screen.

Page 33

Small Pupil Photography Function

If the patient’s pupil does not dilate enough, use the small pupil photography function. When the function is used, pupil diameters 3.3 mm or larger can be photographed.

Press the small pupil photography button.

The lamp on the small pupil photography button lights, and the small pupil photography indicator and a dotted circle appear on the observation monitor.

5 Photography Auxiliary Functions

Effective range of photography

Small pupil photography indicator

Perform alignment and photography in the same manner as for basic operations.

Small pupil photography can be performed in the same manner as for color photography (see page 25). Press the small pupil photography button again to finish the small pupil photography.

t When Auto-fundus observation does not work, tilt the operation lever forward or backward to

unify the top and bottom of the image of the pupil. Then press the alignment button. The retina appears on the observation monitor.

t When the split lines do not appear clearly, Auto-focus will not work. Turn the focus ring and take

images using manual focus photography (see page 31).

t Do not use the small pupil photography function if the patient’s pupil is large enough. The image

will be overexposed.

t The image may contain flare around the edges of the image outside the photography range.

Page 34

5 Photography Auxiliary Functions

Diopter Compensation

Insert the diopter compensation lens into the CR-2 Plus AF and take the photograph. Note that when the diopter compensation is set to the – or + position, the focus indicator does not appear. Turn the focus ring to focus the retinal image in a position that renders the image sharp on the observation monitor.

Diopter compensation mark

t – compensation:

t + compensation: Turn the focus ring clockwise until the end of + position. Then stop and turn

t No compensation: T

The CR-2 Plus AF can provide appropriate images if the diopter of the patient’s eye is within the respective ranges below.

t No compensation: –10 to +15 D

t – compensation: –31 to –7 D

t + compensation: +11 to +33 D

Note Auto-focus is not available when the diopter compensation is set to the – or + position. Take images using Manual Focus Photography (see page 31).

Turn the focus ring counterclockwise until the end of – position. Then stop and turn further; compensation lens is inserted.

further; compensation lens is inserted.

urn the focus ring clockwise (counterclockwise) until the end of + (-) position.

Then stop and turn further; compensation lens is released.

FAF (Fundus Autofluorescence) Photography

This function makes it possible to take fundus autofluorescence images.

Press the photography mode button.

The FAF mode lamp lights and the FAF mark appears on the observation monitor.

Photography mode button

Perform alignment and photography in the same manner as for basic operations.

Fundus autofluorescence photography can be performed in the same manner as for color photography (see page 25).

㻭㻿

㻭㻲

Page 35

Anterior Segment Photography

This function makes it possible to photograph the anterior segment. It is also possible to use the x2 photography function at the same time.

Do not allow external light in the infrared spectrum to enter the position being photographed.

Press the anterior segment photography button.

The anterior segment photography mark appears on the observation monitor.

Anterior segment photography

5 Photography Auxiliary Functions

Anterior segment photography mark

Move the operation lever to align the area to be photographed in the center of the

observation monitor.

Tilt the operation lever to the front or back to focus on the area to be photographed.

t Focus the image so that the area to be photographed can be seen as clearly as possible.

t Make sure that the photography ready lamp light is green.

Press the shutter release button completely.

The flash fires and an image is taken. The preview is displayed on the observation monitor.

Note: Auto-focus and Auto-shot functions are not available on this mode.

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.

t Before connecting or disconnecting the HDMI cable, be sure to turn off the retinal camera and

all other devices.

t Use an external monitor that conforms to IEC 60601-1 or IEC 60950-1. If you use a monitor that

conforms to IEC 60950-1, be sure to also use the isolation transformer that is designated by Canon. For details, contact your sales representative or local Canon dealer.

Page 36

5 Photography Auxiliary Functions

Remove the digital camera cover.

Connect the HDMI cable to the digital camera.

1. Securely insert the HDMI cable into the mini HDMI output terminal on the digital camera.

2. Fit the HDMI cable into the space in the cover, and place the video cable in the notch.

Attach the digital camera cover.

1. Hook the digital camera cover hook onto the strap mount of the digital camera.

2. While taking care to avoid pinching the HDMI cable, insert the cover screw to secure the digital camera cover.

Notch

Cover screw

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.

Turn on the power to the external monitor and the retinal camera.

The image is displayed on the external observation monitor. No image is displayed on the observation monitor of the retinal camera.

Page 37

Maintenance

This section outlines the maintenance instructions for the CR-2 Plus AF: daily inspection, cleaning, disinfecting, refilling chin rest paper, and removing/installing the digital camera.

CAUTION

t For safety reasons, before using the CR-2 Plus AF, be sure to perform the daily inspection.

t Have the CR-2 Plus AF inspected at least once a year by a Canon designated representative to

maintain its performance and reliability.

Daily Inspections

Perform the following inspections before using the CR-2 Plus AF to ensure that it is used safely and correctly. If a problem is found during the inspection and you are unable to correct the problem, please contact your sales representative or local Canon dealer.

Checks before turning on the power

Check the following items before turning on the power.

Cables

1) The power cord and connection cable are not damaged and their insulation is not torn.

2) The power cord is fully and securely inserted into the AC connector on the main unit and the AC outlet.

Main unit

1) The digital camera cover and parts are not damaged or loose.

2) The stage moves when the operation lever is tilted back and forth and right to left.

3) The digital camera is securely installed.

4) The stage lock operates properly.

5) There are no scratches or dirt on the objective lens. Clean the objective lens if it is dirty (see page 38).

Checks after turning on the power

Turn on the CR-2 Plus AF and start the Rics NM 2. Check the following items after starting an examination.

Main unit

1) The power lamp lights.

2) The observation light brightness changes as the observation light brightness button is pressed.

3) A flash is emitted.

4) The main unit moves up and down as the main unit vertical movement ring is turned.

5) The chin rest moves up and down as the CHIN REST button is pressed.

Photographed image

1) Foreign objects that affect the reading of the images or diagnosis do not appear in the photographed image. Place a piece of white paper in front of the objective lens and photograph an image under the following conditions:

 t'MBTIJOUFOTJUZ   4UBOEBSE  t%JPQUFSDPNQFOTBUJPO  $PNQFOTBUJPOMFOTSFMFBTFE  t'PDVTSJOH   5VSOFEDMPDLXJTFNPSFUIBOSPUBUJPO

Page 38

6 Maintenance

Cleaning the Objective Lens

t Do not wipe or rub the objective lens if there is dirt or dust on it. Doing so could scratch the

surface of the lens.

t Do not wipe the objective lens with disinfectant ethanol, eyeglass cleaner, or silicone-coated

paper. Doing so could corrode the surface of the lens or leave streaks.

For information about lens cleaning paper, lens cleaner, and blowers, contact your sales representative or local Canon dealer.

If the objective lens is dirty, clean it according to the procedure below.

Check for any dirt.

Illuminate the objective lens with a penlight to check for dirt.

Blow away any dust or dirt.

Use a blower to blow away any dust or dirt on the lens. Do not use a brush to dust off.

Do not allow the blower to touch the objective lens.

Wipe the objective lens.

1. Slightly dampen a lens cleaning paper with lens cleaner and lightly wipe the objective lens.

2. Starting from the center of the lens, wipe the lens in spirals toward the circumference.

3. Change the lens cleaning paper and wipe the objective lens until the dirt is gone and there are no streaks.

Use lens cleaning paper and lens cleaner designated by Canon.

Page 39

Cleaning the Image Sensor

The digital camera has a self-cleaning sensor unit. Dirt and dust on the front surface of the imaging sensor are automatically removed when the power is turned on or off. This function makes it possible to remove the majority of dirt and dust that may interfere with images. It is not necessary to be aware of this function during normal usage.

To use the self-cleaning sensor unit for cleaning, follow the procedure below.

Make sure that the power switch for the retinal camera is turned off.

Switch the digital camera's power switch from on to off.

The self-cleaning sensor unit starts and the imaging sensor is cleaned.

Check that the dirt and dust have been removed.

Switch the digital camera's power switch to on, photograph an image and check the

image.

6 Maintenance

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 Plus AF

WARNING

t Before cleaning the CR-2 Plus AF, be sure to turn off the power of all connected devices and

unplug the power cord from the AC outlet.

t Do not use alcohol, benzine, thinner or any other flammable cleaning solvent.

Otherwise, fire or electric shock may result.

Do not clean the outside of the CR-2 Plus AF with lens cleaner. It may corrode the surface.

If the outside of the CR-2 Plus AF is dirty, wipe it twice with a soft cloth. First use a cloth that has been soaked in diluted neutral cleanser and well wrung out. Then use a cloth that has been soaked in water and well wrung out.

Page 40

6 Maintenance

Disinfecting the Forehead Rest

CAUTION

t To prevent the risk of infection, wipe the forehead rest with an ethanol solution for each patient.

t The forehead rest may be corroded if a disinfectant other than ethanol is used.

For details on how to disinfect, consult a specialist.

Use a sanitized gauze or wipe that includes disinfectant to clean the forehead rest for each patient.

Refilling Chin Rest Paper

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.

Pull out the right and left chin rest holding pins.

Insert the holding pins into the holes on the right and left of the chin rest paper.

Attach the chin rest paper to the chin rest with the pins pressing into the holes on the

chin rest.

Chin rest paper is a consumable product (sold separately). To purchase chin rest paper, contact your sales representative or local Canon dealer.

Attaching and Removing the Digital Camera

The CR-2 Plus 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.

t Work quickly in a location where there is little dust.

t When removing the digital camera for storage, be sure to attach the supplied camera mount cap

to the retinal camera and the body cap to the digital camera.

t Wipe off any dust from the camera mount cap and the body cap before attaching them.

t Do not touch the lens in the main unit or the mirror in the digital camera. It is not possible to take

good images if dirt, fingerprints, or dust are on these parts.

Page 41

Removing the digital camera

Turn off the power to the retinal camera and remove the plug from the AC outlet.

Loosen the cover screw and remove the digital camera

cover.

Remove the cables from the digital terminal and the

remote control terminal.

6 Maintenance

Remove the DC coupler.

1. Open the battery compartment cover on the digital camera, and then slide the battery lock lever to remove the DC coupler.

2. Close the battery compartment cover.

While holding down the lens release button

on the digital camera, turn the digital camera counterclockwise to remove it.

Attach the caps to the retinal camera and the digital camera mount.

Page 42

6 Maintenance

Installing the digital camera

Be sure to check the following items:

t The power to the retinal camera is off.

t The power plug of the retinal camera is not plugged into an electric outlet.

Attach the digital camera to the retinal camera.

1. Align the positions of the mounting alignment marks on the retinal camera and the digital camera.

2. Fit the digital camera's lens mount to the retinal camera's mount.

3. Turn the digital camera clockwise until it clicks.

Attach the DC coupler to the digital camera.

1. Open the battery compartment cover of the digital camera, and attach the DC coupler.

2. Pass the cord for the DC coupler through the DC coupler cord hole and then close the battery compartment cover.

Mounting alignment mark

Open the terminal cover of the digital camera and attach

the cables to the digital terminal and the remote control terminal.

Attach the digital camera cover to the digital camera.

1. Hook the digital camera cover hook onto the strap mount of the digital camera.

2. Insert the cover screw to secure the digital camera cover.

Page 43

Troubleshooting

If any of the symptoms listed here occurs or if a warning appears in the Rics NM 2 while using the CR-2 Plus 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.

5 short beeps sound and the operation panel lamps blink when the power is turned on.

The observation monitor is dim and hard to see.

The observation monitor does not turn on.

An error appears on the observation monitor.

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 split lines are hard to see. The working distance dots are not

visible.

AF / AS does not work.

Flare appears in the image.

1) White flare appears around the edges of the image.

2) Orange flare appears around the edges of the image.

3) White flare appears on the left side of the image.

4) White flare appears on the right side of the image.

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.

A system error has occurred. Contact your sales representative or local Canon dealer.

Adjust the brightness of the observation monitor. See the Rics NM 2 manual.

Turn on the digital camera.

A malfunction has been detected in the digital camera. Turn off the power to the retinal camera and then turn it on again.

The observation light is too bright. Reduce the observation light brightness.

The retinal camera and the eye are not aligned. Align them correctly.

The patient has an abnormal cornea or cataract or other diseases. Take images using manual focus photography.

The patient has a small pupil. Take images using small pupil photography.

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.

The retinal camera and the patient’s eye are separated. Move the objective lens closer to the patient’s eye.

The retinal camera and the patient’s eye are too close. Move the objective lens away from the patient’s eye.

The retinal camera is too close to the left side of the patient’s eye. Move the objective lens to the right.

The retinal camera is too close to the right side of the patient’s eye. Move the objective lens to the left.

Page 44

7 Troubleshooting

Symptom Cause and remedy

The split lines are not visible.

The split lines do not align.

Cannot capture good images.

Black spots or any artifacts appear in the same place in every captured image.

White spots are visible on the captured image.

The patient's pupil is not dilated enough. Dilate the patient’s pupil. If the pupil is still too small, enable the small pupil photography function.

Eyebrows or eyelashes are blocking the pupil. Instruct the patient to open his/her eye wider.

The patient's eye is cloudy. Focusing cannot be done with the split lines.

The diopter compensation is set to either negative or positive. Set it to the 0 position.

The split line lamps are not lit.

The diopter patient's eye is outside the range of –10 to +15 D. Use the diopter compensation function, turn the focus ring, and focus on the position where the images of the retina look clear at the same time.

The patient's pupil is not dilated enough. Dilate the patient’s pupil. If the pupil is still too small, enable the small pupil photography function.

The retinal camera and the eye are not aligned. Align them correctly.

Focus the image.

Eyebrows or eyelashes are blocking the pupil. Instruct the patient to open his/her eye wider.

The patient's eye is cloudy. Clear images cannot be captured if this is the case.

Adjust the flash intensity, patient's diopter, and small pupil photography function.

The objective lens is dirty. Clean the objective lens (see page 38).

The patient is wearing contact lenses. Instruct the patient to remove his/her contact lenses.

There is dirt or dust on the objective lens. Clean the objective lens (see page 38).

Dirt or dust is stuck to the imaging sensor of the digital camera. Use the self-cleaning sensor unit to clean it. (see page 39).

The objective lens is dirty. Clean the objective lens (see page 38).

The patient's eyelashes are interfering with the image. Instruct the patient to open his/her eye wider, then capture another image.

Page 45

Appendix

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) * 1 D = 1 m

Flash intensity Linked to the photography mode

Can be set manually

Light source Observation light source Infrared LED Flash source Xenon lamp

–1

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

Chin rest range of motion 60 mm

Power supply rating AC 100 V to 240 V, 50/60 Hz, 1.8A to 0.8A

Dimensions 305 (W) × 500 (D) × 513 (H) mm

Weight Approximately 19.9 kg (including 0.8 kg digital camera)

30 mm

Page 46

Appendix

EMC (Electromagnetic Compatibility)

The CR-2 Plus 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 Plus 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:

t3FPSJFOUPSSFMPDBUFUIFSFDFJWJOHEFWJDF t*ODSFBTFUIFTFQBSBUJPOCFUXFFOUIFFRVJQNFOU t$POOFDUUIJTEFWJDFJOUPBOPVUMFUPOBDJSDVJUEJGGFSFOUGSPNUIBUUPXIJDIUIFPUIFSEFWJDFTBSFDPOOFDUFE

If the problem cannot be solved with the above measures, stop using this equipment and consult your sales representative or local Canon dealer.

Precautions on EMC

1. Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the manual.

2. Portable and mobile RF communications equipment can affect medical electrical equipment.

3. Information regarding the cable affecting EMC is as follows. To maintain the optimum EMC performance, use only the designated cables.

Name Type Length Remarks AC Power Cord Non-Shielded 3.0 m fixed-length Supplied USB Cable Shielded Max. 3.0 m Not supplied HDMI Cable Shielded Max. 2.7 m Not supplied

4. The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by Canon sales representative or local Canon dealer as replacement parts for internal components, may result in increased emissions or decreased immunity of the CR-2 Plus AF.

5. The CR-2 Plus AF should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary, the CR-2 Plus AF should be observed to verify normal operation in the configuration in which it will be used.

Page 47

Guidance and Manufacturer’s Declaration for Electromagnetic Emission

The CR-2 Plus AF is intended for use in the electromagnetic environment specified below. The customer or the user of the CR-2 Plus AF should assure that it is used in such an environment.

Emission Test Compliance Electromagnetic Environment – Guidance

RF emissions

EN 55011

CISPR11

RF emissions

EN 55011

CISPR11

Harmonic emissions

EN IEC 61000-3-2

Voltage fluctuations/flicker

emissions

EN IEC 61000-3-3*

* Not applicable to regions where the rated voltage is less than 220 V.

Group 1

Class B

Class A

Complies

The CR-2 Plus 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.

The CR-2 Plus 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.

Appendix

Page 48

Appendix

Guidance and Manufacturer’s Declaration for Electromagnetic Immunity

The CR-2 Plus AF is intended for use in the electromagnetic environment specified below. The customer or the user of the CR-2 Plus AF should assure that it is used in such an environment.

Immunity Test

Electrostatic discharge (ESD) EN IEC 61000-4-2

Electrical fast transient/ burst EN IEC 61000-4-4

Surge EN IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines EN IEC 61000-4-11

Power frequency (50/60Hz) magnetic field EN IEC 61000-4-8

IEC 60601

Test Level

±(2, 4, 6) kV contact

±(2, 4, 8) kV air

±2 kV for power supply lines

±1 kV for input/output lines

±1 kV differential mode

±2 kV common mode <5% U

40% U

(>95% dip in

) for 0.5 cycles

(60% dip in UT)

for 5 cycles

70% U

(30% dip in UT)

for 25 cycles

<5% U U

(>95% dip in

) for 5 sec

Compliance Level Electromagnetic Environment – Guidance

±(2, 4, 6) kV contact

±(2, 4, 8) kV air

±2 kV for power supply lines

±1 kV for input/output lines

±1 kV differential mode

±2 kV common mode <5% U

) for 0.5 cycles

40% U for 5 cycles

70% U for 25 cycles

<5% U U

) for 5 sec

3 A/m 3 A/m

(>95% dip in

(60% dip in UT)

(30% dip in UT)

(>95% dip in

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the CR-2 Plus AF requires continued operation during power mains interruptions, it is recommended that the CR-2 Plus AF be powered from an uninterruptible power supply.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE: U

is the a.c. mains voltage prior to application of the test level.

Page 49

Guidance and Manufacturer’s Declaration for Electromagnetic Immunity

The CR-2 Plus AF is intended for use in the electromagnetic environment specified below. The customer or the user of the CR-2 Plus AF should assure that it is used in such an environment.

Appendix

Immunity Test

Conducted RF EN IEC 61000-4-6

Radiated RF EN IEC 61000-4-3

IEC 60601

Test Level

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

Compliance Level Electromagnetic Environment – Guidance

Portable and mobile RF communications equipment should be used no closer to any part of the CR-2 Plus 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

3 Vrms

3 V/m

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site

survey

, should be less than the compliance

level in each frequency range

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 Plus AF is used exceeds the applicable RF compliance

level above, the CR-2 Plus 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 Plus AF.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Page 50

Appendix

Recommended Separation Distances between Portable and Mobile RF

Communications Equipment and Devices or the CR-2 Plus AF

The CR-2 Plus 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 Plus AF can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CR-2 Plus AF as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output

power of transmitter

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

11.2 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 metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

reflection from structures, objects and people.

150 kHz to 80 MHz

d = 1.2 √P

Separation distance according to frequency of transmitter

80 MHz to 800 MHz

d = 1.2 √P

800 MHz to 2.5 GHz

d = 2.3 √P

Page 51

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 43), 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 Plus 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 Plus 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.

t Baseboard (USB connector)

t Xenon lamp

Page 52

Page 53

Page 54

*L-IE-5198B*

CANON INC. Medical Equipment Group

30-2, Shimomaruko 3-chome, Ohta-ku, Tokyo, Japan Telephone: (81)-3-3758-2111

Distributed by:

CANON U.S.A., INC. Healthcare Solutions Division

15955 Alton Parkway Irvine, CA 92618, U.S.A. Telephone: (1)-949-753-4160

CANON EUROPA N.V. Medical Products Division

Bovenkerkerweg 59, 1185 XB Amstelveen, The Netherlands Telephone: (31)-20-545-8926

CANON SINGAPORE PTE. LTD. Medical Equipment Products Division

1 HarbourFront Avenue, #04-01 Keppel Bay Tower, Singapore 098632 Telephone: (65)-6799-8888

CANON AUSTRALIA PTY. LTD. Optical Products Division

1 Thomas Holt Drive, North Ryde, Sydney N.S.W. 2113, Australia Telephone: (61)-2-9805-2000