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Canon CR-2 2Safety, Regulatory Information, USA and Canada, Device Classification, Directives and Standards

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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

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Contents

Digital Retinal Camera Operation Manual Important Disclaimers Installation Trademarks Copyright Contents 1Introduction Features Indications for Use Checking Included Items Conventions Used in This Manual 2Safety Regulatory Information European Union Deutschland Safety Precautions 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 Do not plug or unplug the power plug with wet hands Unplug the plug periodically and remove any dust or dirt Do not install in locations exposed to water, steam, moisture or dust Do not install in locations exposed to salt, sulfur or corrosive gas Do not install in locations that are unstable or exposed to Keep the forehead rest and chin rest clean Slowly move the main unit towards the patient’s eye when taking an image Check the image before using the CR-2 Be sure to turn off the power when not in use Do not touch the main unit or the chin rest while they are moving Notes on Using CR-2 Environment of use Transportation Disposal European Union (and EEA*) only Rating Label Display 3Names of Parts Retinal Camera Page Operation Panel Observation Monitor 4Basic Operations Flow of Operation Connecting Cables Preparing for an Examination Page Patient Setup Alignment Page Page Photography Finishing an Examination 5Photography Auxiliary Functions x2 Photography Small Pupil Photography Function Diopter Compensation Anterior Segment Photography External Monitor Page 6Maintenance Daily Inspections Cleaning the Objective Lens Cleaning the Image Sensor Cleaning the Outside of the CR-2 Disinfecting the Forehead Rest Refilling Chin Rest Paper Attaching and Removing the Digital Camera Removing the digital camera Installing the digital camera 7Troubleshooting Page Appendix Specifications EMC (Electromagnetic Compatibility) Guidance and Manufacturer’s Declaration for Electromagnetic Emission Guidance and Manufacturer’s Declaration for Electromagnetic Immunity Page Recommended Separation Distances between Portable and Mobile RF Communications Equipment and Devices or the CR-2 Warranty and Repair Service