Canon CR-2 User Manual

Digital Retinal Camera

Operation Manual

Make sure you read this manual before using the instrument. Keep this manual safely so that you can use it in the future.

Important

Disclaimers

Thank you for purchasing the Canon Digital Retinal Camera CR-2 (referred to as “CR-2” in this manual). The operation manuals for this instrument consist of the “Digital Retinal Camera CR-2 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.

• The CR-2 must only be used by a doctor or a legally qualified person.

• The user is responsible for managing the usage and maintenance of medical equipment. We

suggest that someone be put in charge of maintenance to ensure that the CR-2 is kept in good condition and can be used safely.

• 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.

• Canon takes no responsibility for direct or consequential damages resulting from the use or the inability to use the CR-2. In addition, no compensation is available for lost image data, regardless of the cause of the loss of the image data.

• 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.

Installation

Trademarks

• Medical examinations are the responsibility of a doctor. Canon takes no responsibility for diagnostic results.

• Follow the laws relating to the production, processing, analysis, and storage of medical images. The user is responsible for maintaining the confidentiality of image data.

• The information in this manual may be changed without prior notice.

• Although we have made every effort to ensure the accuracy of the information in this manual, if you

have any queries regarding the contents, please contact the Canon representative or distributor from whom you purchased the CR-2.

• Ask the Canon representative or distributor from whom you purchased the CR-2 to install it.

• Canon and the Canon logo are trademarks of Canon Inc.

• Other system names and product names that appear in this manual are trademarks of their

respective companies.

• The copyright of this manual belongs to Canon Inc.

• Unauthorized reproduction, duplication, or reprinting of this manual in whole or in part is prohibited.

Contents

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

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

3 Names of Parts ......................................................................................... 17

4 Basic Operations ...................................................................................... 21

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

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

Components .............................................................................................. 5

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

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

Safety Precautions .....................................................................................9

Notes on Using CR-2 .............................................................................. 13

Rating Label Display ................................................................................ 16

Retinal Camera ........................................................................................ 17

Operation Panel ....................................................................................... 19

Observation Monitor ................................................................................ 20

Flow of Operation .................................................................................... 21

Connecting Cables .................................................................................. 22

Preparing for an Examination .................................................................22

Setup for Patient ...................................................................................... 24

Alignment ................................................................................................ 25

Photography ............................................................................................. 28

Finishing an Examination ........................................................................ 29

5 Photography Auxiliary Functions ........................................................... 30

x2 Photography ........................................................................................ 30

Small Pupil Photography Function ........................................................... 30

Diopter Compensation ............................................................................. 31

Anterior Eye Photography ........................................................................32

External Monitor ....................................................................................... 32

6 Maintenance ..............................................................................................34

Maintenance and Inspection ................................................................... 34

Cleaning the Objective Lens ................................................................... 35

Cleaning the Image Sensor ..................................................................... 36

Cleaning the Outside of the CR-2 ........................................................... 36

Disinfecting the Forehead Rest ................................................................ 37

Refilling Chin Rest Paper ......................................................................... 37

Attaching and Removing the Digital Camera .......................................... 37

7 Troubleshooting ........................................................................................ 40

Appendix ....................................................................................................... 42

Specifications .......................................................................................... 42

EMC (Electromagnetic Compatibility) ...................................................... 43

Warranty and Repair Service .................................................................. 47

Introduction

Features

The Canon Digital Retinal Camera CR-2 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 has the following features.

Reduced flash intensity

The CR-2 can take images at ISO 1600 at the standard flash intensity, and ISO 6400 in low flash intensity mode. This reduces patient discomfort caused by light glare.

Compact, user-friendly design

The CR-2 is designed to be even smaller, more lightweight and compact. This makes it easier to assist patients and provides significantly improved ease-of-operation. An integrated operation lever has been adopted for vertical movement of the main unit, switching between anterior eye and retina, and focus operations, which significantly improves alignment operability.

Special digital camera

The CR-2 is equipped with a special digital camera using EOS digital technology. This enables the CR-2 to fully maximize Canon technology for shooting high-quality, high-resolution diagnostic images.

Small pupil photography function

The CR-2 take retinal images through pupils of the normal diameters from 4.0 mm. When using the small pupil photography function, it can take through pupils of the diameters from 3.3 mm.

System optimized for digital photography

With the Retinal imaging control software, the photographed images can be browsed, processed, stored, output to the DICOM storage server, exported in DICOM or JPEG format and output to a printer.

Indications for Use

For U.S.A.

The device 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 image and record retinal fundus through the pupil without contact with subject’s eye for the purpose of diagnosis by way of producing fundus image information.

Components

1 Introduction

Digital Retinal Camera CR-2

Main unit

Digital camera

Digital camera specialized for the CR-2.

Power cord

Connects the CR-2 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.

Video cable

Use to connect an external monitor.

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.

Dust cover

Use it to cover the CR-2 when it's not being used.

Operation Manual for the CR-2—this document

Describes the handling precautions and operating instructions for the CR-2.

CD-ROM—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.

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.

Body cap

Initially covers the mount on the digital camera.

Optional products

External eye fixation lamp Chin rest paper—500 sheets

1 Introduction

Conventions Used in This Manual

This manual uses the following symbols to indicate safety precautions that are important for using the CR-2 safely. Always follow the advice in these safety 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 or damage other devices.

This symbol indicates things that must not be done (prohibited actions).

This symbol indicates things that must be done.

This symbol indicates important advice that we strongly recommend be followed while operating the CR-2.

This symbol indicates supplementary explanations or advice for operating the CR-2.

Safety

Regulatory Information

The following sections list the classifications applicable to the CR-2 and the directives and standards that the CR-2 complies with.

Device Classification

Protection against electric shock Class I equipment

Degree of protection against electric shock Type B applied parts

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

Mode of operation Continuous operation

Directives and Standards

USA and Canada

UL 60601-1 CAN/CSA C22.2 No.601.1 IEC 60601-1: 1988/A1: 1991/A2: 1995

IEC 60601-1-1 Ed. 2.0: 2000 Medical electrical equipment – Part 1-1: General

IEC 60601-1-2: Ed. 2.1: 2004 Medical electrical equipment – Part 1-2: Collateral standard:

Not suitable

Medical electrical equipment – Part 1: General requirements for safety

requirements for safety – Collateral standard: Safety requirements for medical electrical systems

Electromagnetic compatibility – Requirements and tests

IEC 60601-1-4: Ed. 1.1: 2000 Medical electrical equipment – Part 1-4: Collateral standard:

Programmable electrical medical systems

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: 2003 ISO 10993-5: 1999 ISO 10993-10: 2002/A1: 2006

Biological evaluation of medical devices – Evaluation and testing

2 Safety

European Union

93/42/EEC Medical Device Directive

EN 60601-1 Ed. 3.0: 2006 Medical electrical equipment – Part 1: General requirements

for safety

EN 60601-1-2: 2007 Medical electrical equipment – Part 1-2: Collateral standard:

Electromagnetic compatibility – Requirements and tests

EN 60601-1-6: 2004 Medical electrical equipment – Part 1-6: General

requirements for safety – Collateral standard: Usability

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

EN 62366: 2008 Medical device – Application of usability engineering to

medical devices

EN ISO 14971: 2007 Medical device – Application of risk management to

medical devices

EN ISO 15004-1: 2006 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: 2003 EN ISO 10993-5: 1999 EN ISO 10993-10: 2002/A1: 2006

Biological evaluation of medical devices – Evaluation and testing

Deutschland

Während des Betriebs liegt der Schalldruckpegel dieses Instruments bei 70 dB(A) oder weniger gemäß EN ISO 7779.

Safety Precautions

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

2 Safety

WARNING

Prohibi ted

Do not damage the power cord

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

• Do not damage or modify the power cord.

• Do not forcibly bend, twist or pull the power cord.

• Do not hold the power cord when removing it from the AC outlet. Be sure to hold

the plug.

• Do not use an extension cable with the power cord. Connect it directly to the AC outlet.

Handle the power cord carefully. If the cord is damaged, contact a Canon representative or distributor for a replacement. Damaged cord may result in fire or electric shock.

Do not disassemble or modify

Disassembled or modified instrument may result in fire or electric shock. Since the CR-2 incorporates high-voltage parts that may cause electric shocks, touching them may cause death or serious injury.

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

Do not place near to a flammable solvent. Fire may result if the solvent spills or evaporates and makes contact with internal electric parts. Some disinfectants are flammable. Be sure to take care when using them.

Prohibi ted

Stop using immediately if there is an abnormality or problem If an abnormality occurs, immediately unplug the power plug

and turn off the power of all the devices

• Smoke is emitted

• An unusual smell

• An unusual noise

• Foreign matter gets inside

• Damaged

Fire or electric shock may result if you keep using in such condition. Immediately turn off the power of CR-2, unplug the power plug and turn off the power of all connected devices. Then, contact a Canon representative or distributor.

Do not place anything on top

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.

Do not use a power supply voltage other than that specified on the rating label

Do not use any power cord other than the 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.

2 Safety

WARNING

Prohibi ted

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 place, dust around the plug will attract moisture, and this may cause insulation failure which 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 with flammable solvent

Before cleaning the CR-2, for safety reasons, 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

Before inspecting the instrument or cables, for safety reasons, be sure to turn off the power of all the devices. Otherwise, it may result in electric shock.

CAUTION

Prohibi ted

Do not play the supplied CD-ROM in any CD Player unsupporting data CD-ROMs

Playing the CD-ROM in an audio CD player may damage the speaker. It is also possible to suffer hearing loss from listening with headphones to the loud sounds of the CD-ROM on an audio CD player.

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 lose its balance 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 you want, avoid putting any obstructions near the AC outlet. The power plug left plugged in an emergency may result in fire or electric shock.

Do not block the vent holes

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

Prohibi ted

2 Safety

CAUTION

Prohibi ted

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 the patient’s hands and fingers there.

Be sure to turn off the power before moving the CR-2

Before moving the CR-2, 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.

Do not hold the face rest or digital camera when moving the CR-2

When carrying the CR-2, 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 level. Do not hold it by the digital camera or the face rest or any other parts, as they may come off and result in injury.

Hold the CR-2 when connecting or disconnecting a cable

When connecting or disconnecting the power cord or any cable, for safety reasons, 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. Be sure that the entire system conform 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, it may result in electric shock. For details, please contact a Canon representative or distributor.

Keep the forehead rest and chin rest clean

To prevent the risk of infection, wipe the forehead rest with ethanol solution or any other disinfectant whenever changing patients. To ensure cleanliness, replace the chin rest paper whenever the patient is changed. If the chin rest paper is not being used, be sure to disinfect the chin rest whenever the patient is changed. For details on how to disinfect, consult a specialist. The forehead rest may be corroded if a disinfectant other than those above is used or if another disinfectant is added to ethanol. Consult a specialist in this case as well.

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

Before using the CR-2, be sure to take a test image to ensure that there is no foreign matter present that can affect image readings or diagnosis.

2 Safety

CAUTION

Prohibi ted

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 is not being used. Also, unplug the power plug from the AC outlet and put on the cover when the CR-2 is not going to be used for a long time. Otherwise, dust or any foreign matter may accumulate and result in fire.

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

The main unit and the chin rest move to the center position when the CR-2 main unit is turned on or a study is finished with the control software. Do not touch the main unit and the chin rest while they are moving. At the same time, keep the patient’s chin away from the chin rest.

Before packing the CR-2, 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 regularly

Before using the CR-2, for safety reasons, be sure to perform the daily inspection. Have a regular inspection performed for the CR-2 at least once a year at the representative designated by Canon.

Notes on Using CR-2

Digital camera

• The attached digital camera is designed for the CR-2. The specifications differ from commercially available Canon digital cameras, so it can be used only for observing and taking photographs of peoples' eyes. Do not use the digital camera separately detaching from the main unit or it may cause failure on the CR-2.

• If any problems with the CR-2's digital camera occur or repairs are needed, contact the Canon representative or distributor from whom you purchased the CR-2.

Before use

• Inspect the CR-2 every day, make sure that no foreign matter is present that can affect image readings or diagnoses.

• Check and clean the objective lens before taking an image. Any stains or scratches on the objective lens will appear as white spots.

• Sudden heating of a room during winter or in cold regions may cause condensation to form on the objective lens or on optical parts inside the CR-2. In this case, wait until condensation disappears before taking images.

2 Safety

• Do not touch the lens part of the retinal camera or the mirror part of the digital camera when attaching and detaching the digital camera from the retinal camera. If any dirt, fingerprints, dust, or other foreign object is on the lens or mirror, you cannot take a good image.

After use

• After using the CR-2, 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. You cannot take good images if the objective lens is dusty.

• If the digital camera is detached and left unattached, dirt and dust may enter the retinal camera and the digital camera. Be sure to always attach the caps to the respective mounts.

Cleaning and disinfection

• Do not allow the blower to touch the lens.

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

• Do not wipe the lens with ethanol solution, eyeglass cleaner, or silicone-coated paper. Doing so

could corrode the surface of the lens or leave streaks.

• Do not clean the outside of the CR-2 with lens cleaner. Doing so could damage the outside of the CR-2.

• Never use alcohol, benzine, thinner, or other solvents to clean the outside of the CR-2. Doing so damages the outside of the CR-2.

• Never use ethanol solution to clean the outside of the CR-2, except the forehead rest and the chin rest. Doing so damages the outside of the CR-2.

• If the chin rest paper is not being used, disinfect the chin rest for each patient in the same way as the forehead rest.

2 Safety

Environment of use

• Use, store, and transport the CR-2 in an environment that is within the range of the following conditions.

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

Storage and transportation environment

• Do not install, store, or leave the CR-2 in a very hot or humid environment. Also, do not use the CR-2 outside. Doing so may cause a malfunction or misoperation.

• 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.

• When the CR-2 is not being used, attach the objective lens cap and place the dust cover over the CR-2.

Installation

• Ask the Canon representative or distributor from whom you purchased the CR-2 to install it.

Temperature Humidity Atmospheric pressure

800 to 1060 hPa

condensation)

–30 to 60°C 10 to 60% RH (no

condensation)

700 to 1060 hPa

Transportation

• A strong shock to the CR-2 may put it out of alignment. Please handle it carefully.

• Lower the main unit and chin rest to the bottom. To automatically lower them, turn on the power

while holding down the set button.

• Be sure to turn off the CR-2's power switch, remove the AC plug from the outlet, and disconnect any cables connected to other equipment.

• Align the stage with the base, and then lock the stage with the stage lock lever.

• Carry the CR-2 by the indentations for lifting at its front and rear, and keep it level.

• Do not hold the face rest or digital camera when lifting the main unit.

• The CR-2 needs to be protected from vibration and shocks when it is transported in a vehicle or

over long distances. For details, contact the Canon representative or distributor from whom you purchased the CR-2.

Disposal

2 Safety

Disposal of this product in an unlawful manner may have a negative impact on health and on the environment. When disposing of this product, therefore, be absolutely sure to follow the procedure which is in conformity with the laws and regulations applicable in 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/environment. * EEA: Norway, Iceland and Liechtenstein

For California, USA Only

Included battery contains Perchlorate Material—Special handling may apply. See http://www.dtsc.ca.gov/hazardouswaste/perchlorate/ for details.

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