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. 
						

							2
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 someone be put in charge of maintenance to ensure that the CR-2 is kept in good 
condition and can be used safely. 
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. 
•	 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. 
Installation 
•	Ask the Canon representative or distributor from whom you purchased the CR-2 to install it. 
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.  
						

							3
1 Introduction ........................................................................\
......................... 4
Features  ........................................................................\
.............................. 4
Indications for Use  ........................................................................\
............. 4
Components   ........................................................................\
...................... 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
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
Contents  
						

							4
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.
1
 Introduction  
						

							1 Introduction
5
Components 
Digital Retinal Camera CR-2 
Main unit Video cable 
Use to connect an external 
monitor. 
Digital camera 
Digital camera specialized for 
the CR-2. Digital camera cover 
Protects the cable that is 
connected to the digital 
camera. 
Power cord 
Connects the CR-2 to an AC 
outlet. (3 m) 
USA and Canada only:  
   Plug type: VM0275 Hospital-
GradeChin rest paper
100 sheets provided. 
Camera mount cap 
Initially covers the camera 
mount on the retinal camera. Objective lens cap
Initially covers the objective 
lens. 
Dust cover
Use it to cover the CR-2 when 
it's not being used. Body cap 
Initially covers the mount on 
the digital camera. 
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. 
Optional products 
External eye fixation lamp
Chin rest paper—500 sheets   
						

							6
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. 
 WARNINGA warning that incorrect operation may result in death or serious injury. 
 CAUTIONA caution that incorrect operation may result in serious injury. 
CAUTIONA 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.   
						

							7
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 shockClass 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 Not suitable
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
Medical electrical equipment – Part 1: General requirements 
for safety
IEC 60601-1-1 Ed. 2.0: 2000 Medical electrical equipment – Part 1-1: General 
requirements for safety – Collateral standard: Safety 
requirements for medical electrical systems
IEC 60601-1-2: Ed. 2.1: 2004 Medical electrical equipment – Part 1-2: Collateral standard: 
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  
						

							8
2 Safety
European Union
93/42/EECMedical 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.  
						

							2 Safety
9
Safety Precautions
To prevent injuries and data loss, operate the CR-2 correctly by following the safety precautions.
 WARNING
Prohibited
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.
Prohibited
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.
Prohibited
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.
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.
Prohibited
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.
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 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.  
						

							10
2 Safety
 WARNING
Prohibited
Do not plug or unplug the power plug with wet hands
Do not plug or unplug the power plug or handle any other parts with wet hands. 
Otherwise, fire or electric shock may result.
Unplug the plug periodically and remove any dust or dirt 
around the plug and the AC outlet
If the cord is kept plugged in for a long time in a dusty, humid or sooty 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.
Prohibited
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.
Prohibited
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.
 CAUTION
Prohibited
Do not install in locations exposed to water, steam, moisture 
or dust
Doing so may cause problems or malfunctions.
Prohibited
Do not install in locations exposed to salt, sulfur or corrosive 
gas
Doing so may result in corrosion of the instrument, problems or malfunctions.
Prohibited
Do not install in locations that are unstable or exposed to 
vibration
The vibration may knock over the instrument or the instrument may lose its balance 
and fall, resulting in a malfunction or injury.
Prohibited
Do not place anything near the power plug
To make it easy to unplug the power plug at any time 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.
Prohibited
Do not block the vent holes
Doing so may cause the internal temperature to rise and result in fire.