Canon CR-2 User Manual

Digital Retinal Camera

Operation Manual

Make sure you read this manual before using the instrument.

Keep this manual in a safe place so that you can use it in the future.

Thank you for purchasing the Canon Digital Retinal Camera CR-2 (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.

Important

•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 a dedicated individual is assigned responsibility for maintenance to ensure that the CR-2 is kept in good condition and can be used safely.

•Rx Only (USA) Federal law restricts this device to sale by or on the order of a physician.

Disclaimers

•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.

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

•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.

•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 questions regarding the contents, please contact your sales representative or local Canon dealer.

Installation

• Request your sales representative or local Canon dealer to install the CR-2.

Trademarks

•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.

Copyright

•The copyright of this manual belongs to Canon Inc.

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

2

Contents

1 Introduction.................................................................................................	4
Features......................................................................................................	4
Indications for Use .....................................................................................	4
Checking Included Items ...........................................................................	5
Conventions Used in This Manual ............................................................	6
2 Safety ...........................................................................................................	7
Regulatory Information...............................................................................	7
Safety Precautions .....................................................................................	9
Notes on Using CR-2 ...............................................................................	13
Rating Label Display ................................................................................	16
3 Names of Parts .........................................................................................	17
Retinal Camera ........................................................................................	17
Operation Panel .......................................................................................	19
Observation Monitor ................................................................................	20
4 Basic Operations ......................................................................................	21
Flow of Operation ....................................................................................	21
Connecting Cables ..................................................................................	22
Preparing for an Examination...................................................................	22
Patient Setup............................................................................................	24
Alignment ................................................................................................	25
Photography .............................................................................................	28
Finishing an Examination ........................................................................	29
5 Photography Auxiliary Functions ...........................................................	30
x2 Photography ........................................................................................	30
Small Pupil Photography Function...........................................................	30
Diopter Compensation .............................................................................	31
Anterior Segment Photography ...............................................................	32
External Monitor.......................................................................................	32
6 Maintenance..............................................................................................	34
Daily Inspections .....................................................................................	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 ..................................................................	48

3

1Introduction

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 800/1600 at the standard flash intensity, and ISO 3200/6400 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 than the previous model. This makes it easier to assist patients and provides significant ease of operation.

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.

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 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 output 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 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 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.

4

1 Introduction

Checking Included Items

Digital Retinal Camera CR-2	Digital camera cover
Main unit	Protects the cable that is
	connected to the digital
	camera.
Digital camera	Chin rest paper
Digital camera specialized for	100 sheets provided.
the CR-2.
Power cord	Objective lens cap
Connects the CR-2 to an AC	Initially covers the objective
outlet. (3 m)	lens.
USA and Canada only:
Plug type: VM0275 Hospital-
Grade
Camera mount cap	Body cap
Initially covers the camera	Initially covers the mount on
mount on the retinal camera.	the digital camera.
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.

Warranty Card (for USA model only)

WEEE Directive Leaflet (for EU model only)

Installation Report

Optional products

External eye fixation lamp

Chin rest paper—500 sheets

5

1 Introduction

Conventions Used in This Manual

Symbols to indicate safety precautions

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			A warning that incorrect operation may result in death or serious injury.
	CAUTION			A caution that incorrect operation may result in serious injury.
	CAUTION			A caution that incorrect operation may break the CR-2 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.
				This symbol indicates supplementary explanations or advice for operating the
				CR-2.

References

This manual uses the following style to indicate reference destination.

Example: (see page 15)

6

2Safety

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	Not suitable
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	Medical electrical equipment – Part 1: General
CAN/CSA C22.2 No.601.1	requirements for safety
IEC 60601-1: 1988+A1: 1991+A2: 1995
IEC 60601-1: 2005
IEC 60601-1-1: 2000	Medical electrical equipment – Part 1-1: General
	requirements for safety – Collateral standard: Safety
	requirements for medical electrical systems
IEC60601-1-2: 2001+A1: 2004	Medical electrical equipment – Part 1-2: Collateral
	standard: Electromagnetic compatibility – Requirements
	and tests
IEC 60601-1-4: 1996+A1: 1999	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: 2009	Biological evaluation of medical devices – Evaluation and
ISO 10993-5: 2009	testing
ISO 10993-10: 2009

7

2 Safety

European Union

93/42/EEC	Medical Device Directive
EN 60601-1: 1990+A1: 1993+A2: 1995	Medical electrical equipment – Part 1: General
EN 60601-1: 2006	requirements for safety
IEC 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: 2007	Medical electrical equipment – Part 1-2: Collateral
	standard: Electromagnetic compatibility – Requirements
	and tests
IEC60601-1-4: 1996+A1: 1999	Medical electrical equipment – Part 1-4: General
	requirements for safety – Collateral standard:
	Programmable electrical medical systems
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: 2009	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
ISO 15004-2: 2007	Ophthalmic instruments – Part 2: Light hazard protection
EN ISO 10993-1: 2009	Biological evaluation of medical devices – Evaluation and
EN ISO 10993-5: 2009	testing
EN ISO 10993-10: 2009

Deutschland

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

8

2 Safety

Safety Precautions

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

WARNING		To avoid the risk of electric shock, this equipment must only
		be connected to a supply mains with protective earth.
		Do not damage the power cord.
	Prohibited	• 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.
		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 power strip and an extension cable.
	Prohibited	Connect the power cord directly to the AC outlet. Do not use a multiple power strip
		and an extension cable with it.
		Do not disassemble or modify.
	Prohibited	A disassembled or modified instrument may result in fire or electric shock. Because
		the CR-2 incorporates high-voltage parts that may cause electric shocks, touching
		them may cause death or serious injury.
		Do not leave alcohol, thinner, or any flammable chemicals
		near the instrument.
	Prohibited	Do not place the CR-2 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.
		• Smoke is emitted
		• An unusual smell
		• An unusual noise
		• Foreign matter gets inside
		• Devices are damaged.
		Fire or electric shock may result if you continue using in such conditions.
		Immediately turn off the power of CR-2, unplug the power plug and turn off the
		power of all connected devices. Then, contact your sales representative or local
		Canon dealer immediately.
		Do not place anything on top of the device.
	Prohibited	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.

9

2 Safety

WARNING		Do not use a power supply voltage other than that specified
		on the rating label.
	Prohibited	Do not use any power cord other than the one supplied.
		Use the power voltage specified on the rating label. Otherwise, fire or electric shock
		may result.
		The supplied power cord is designed exclusively for this product. Do not use any
		other power cord.
		Do not plug or unplug the power plug with wet hands.
	Prohibited	Do not plug or unplug the power plug or handle any other parts with wet hands.
		Otherwise, fire or electric shock may result.
		Unplug the plug periodically and remove any dust or dirt
		around the plug and the AC outlet.
		If the cord is kept plugged in for a long time in a dusty, humid or sooty environment,
		dust around the plug will attract moisture, resulting in possible insulation failure that
		may result in a fire.
		Insert the power plug completely.
		Insert the power plug completely into the AC outlet. If a pin of the power plug makes
		contact with metal or any conductive object, fire or electric shock may result.
		Do not clean the CR-2 with flammable solvent.
	Prohibited	For safety reasons, before cleaning the CR-2, be sure to turn off the power of all the
		devices and unplug the power cord from the AC outlet. Do not use alcohol, benzine,
		thinner or any other flammable solvent.
		Otherwise, fire or electric shock may result.
		Turn off the power before inspection.
		For safety reasons, before inspecting the instrument or cables, be sure to turn off
		the power of all the devices.
		Otherwise, electric shock may result.
		Do not play the supplied CD-ROM in any CD player that does
		not support data CD-ROMs.
	Prohibited	Playing the CD-ROM in an audio CD player may damage the speaker. Playing the
		CD-ROM in an audio CD player may also cause hearing loss if listened to with
		headphones.
		Be sure to turn off the power before moving the CR-2.
		Before moving the CR-2, make sure that the power is turned off, the power
		plug is removed from the AC outlet, and any cables that are connected to other
		devices are disconnected.
		Do not touch conductive parts of non-medical equipment and
		the patient simultaneously.
	Prohibited	Otherwise, electric shock may result.

Use an isolation transformer when this system is connected to a network.

Connect an isolation transformer conforming to IEC 60601-1 for networks between the computer and HUB.

Otherwise, there is a risk of electric shock if the network is faulty.

10

2 Safety

CAUTION		Do not install in locations exposed to water, steam, moisture
		or dust.
	Prohibited	Doing so may cause problems or malfunctions.
		Do not install in locations exposed to salt, sulfur or corrosive
		gas.
	Prohibited	Doing so may result in corrosion of the instrument, problems or malfunctions.
		Do not install in locations that are unstable or exposed to
		vibration.
	Prohibited	The vibration may knock over the instrument or the instrument may become
		unbalanced and fall, resulting in a malfunction or injury.
		Do not place anything near the power plug.
	Prohibited	To make it easy to unplug the power plug at any time, avoid putting any obstructions
		near the AC outlet.
		Fire or electric shock may result if the power plug is not unplugged during an
		emergency.
		Do not block the vent holes.
	Prohibited	Doing so may cause the internal temperature to rise and result in fire.
		Do not place your hands or fingers on the base.
	Prohibited	Your hand or fingers may be pinched and injured when the stage moves to either
		side.
		Similarly, instruct the patient not to place his/her hands or fingers on the base.
		Do not hold the head rest or digital camera when moving the
		CR-2.
	Prohibited	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 head rest or any other parts, as they may come
		off and result in injury.
		Hold the CR-2 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. 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.

11

2 Safety

CAUTION

CAUTION

Keep the forehead rest and chin rest clean.

To prevent the risk of infection, wipe the forehead rest with disinfectant ethanol for each patient. To ensure cleanliness, replace the chin rest paper for each patient. If the chin rest paper is not being used, be sure to disinfect the chin rest for each patient.

For details on how to disinfect, consult a specialist. The forehead rest may be corroded if a disinfectant other than those above is used.

Slowly move the main unit 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.

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, remove 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 or the chin rest while they are moving.

Prohibited	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 or the chin rest while they are moving. 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 periodically.

For safety reasons, before using the CR-2, be sure to perform the daily inspection. Have a periodically inspection performed for the CR-2 at least once a year by a Canon designated representative to maintain its performance and reliability.

Do not turn off the CR-2 or the computer during image capture, data transfer, or backup.

Prohibited	Doing so might damage the computer or corrupt the data.

Do not disconnect the cable between the CR-2 and the computer during image capture or data transfer.

Prohibited	Doing so might damage the computer or corrupt the data.

12

2 Safety

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. 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 may result.

•If any problems occur or repairs are needed with the CR-2’s digital camera, contact your sales representative or local Canon dealer.

Before use

•Inspect the CR-2 daily. Make sure that no foreign matter is present that can affect image readings or diagnoses.

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

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

•Do not touch the lens of the retinal camera or the mirror of the digital camera when attaching and detaching the digital camera from the retinal camera. If any dirt, fingerprints, dust, or other foreign objects are on the lens or mirror, you will not be able to take a good image.

After use

•After using 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 their respective mounts.

Cleaning and disinfection

•Do not allow the blower to touch the lens.

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

•Do not wipe the lens with disinfectant ethanol, eyeglass cleaner, or silicone-coated paper. Doing so could corrode the surface of the lens or leave streaks.

•Do not clean the outside of the CR-2 with a 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 disinfectant ethanol to clean the outside of the CR-2, with the except of 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 manner as you do for the forehead rest.

•Carry out all cleaning, sterilization and disinfection procedures specified in the instruction manual for each peripheral device in the system.

13

2 Safety

Environment of use

•Use, store, and transport the CR-2 in an environment that is within the range of the following conditions. Use the original packaging to store or ship it.

	Temperature	Humidity	Atmospheric pressure
Environment of use	10 to 35°C	30 to 90% RH (no	700 to 1060 hPa
		condensation)
Storage and transportation	–30 to 50°C	10 to 95% RH (no	700 to 1060 hPa
environment		condensation)

•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

•Request your sales representative or local Canon dealer to install the CR-2.

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

Transportation

•Lower the main unit and chin rest to the bottom. To automatically lower them, turn on the power while holding down the set button.

•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.

•When lifting the main unit, do not hold the head rest or digital camera. Hold the main unit by the indentations for lifting at its front and rear, and keep it level.

•When transporting the CR-2, align the stage with the base, and then lock the stage with the stage lock lever.

•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 your representative or local Canon dealer.

14

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

15

2 Safety

Rating Label Display

The position and contents of the label attached on the CR-2 is shown below.

Follow the information on the label to use the CR-2 appropriately.

The following table describes the marks and indications on the rating label.

Alternating current

Type B

Class I device indicating manufacturer’s declaration of conformance with the Annex VII of the Medical Device Directive, 93/42/EEC

Certification mark that shows the product has passed the tests by

TUV Rheinland of conformity with the medical device regulations in the

European Union.

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.

Certification mark that indicates the product complies with UL 60601- 1 and CAN/CSA 22.2 No. 601.1, that specifies protection against fire, electric shock, and mechanical hazards

Caution: Check the documentation provided.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Year and month of manufacture	Example: October 2011
Serial number in six digits	Example: 123456

16