Related Manuals for Leica Envisu C2300
Summarization of Contents
Product Information
Symbol Key
Explains common symbols used throughout the User Manual, detailing their meanings and applications.
Intended Use and Contraindications
Intended Use of the System
Describes the Leica Envisu™ Spectral Domain Ophthalmic Imaging system's purpose and application.
Contraindications for Use
Details specific conditions or practices that contraindicate the use of the device, emphasizing safety.
System Specifications
Model Numbers
Lists the model numbers covered by this document.
Physical Dimensions and Weight
Provides the physical dimensions and weight of the Envisu system.
Operating and Storage Environment
Outlines the environmental conditions, including temperature and humidity, for operation and storage.
Standards Compliance
Lists the various safety and performance standards the device conforms to.
Optical Source Description
Details the type of light source used in the system and its operational wavelength.
Operational Parameters
Details the system's mode of operation, power requirements, and power cord specifications.
Electrical and Water Protection
Specifies the type of protection against electrical shock and water ingress for the foot pedal.
Regulatory Classification
Provides regulatory classifications for the device, including medical device and laser product status.
Warnings and Cautions
Hazard Warnings
Covers explosion hazards, electrical shock risks, and optical radiation hazards.
Environmental and Health Precautions
Details cautions regarding moisture, material allergies, and phototoxicity.
Grounding Reliability Note
Provides important notes on grounding reliability for specific regions (Canada, Europe, Australia).
Phototoxicity and ISO Compliance Notes
Further details on phototoxicity and compliance with ISO 15004-2:2007 for light emission.
Safety
Operational Safety and High Voltage
Covers operational safety, high voltage dangers, and proper disconnection procedures.
Environmental Conditions
Environmental Requirements and Hazards
Details product warranty conditions, environmental requirements like humidity, and explosion hazards.
Electromagnetic Compatibility (EMC)
EMC Compliance, Precautions, and Effects
States EMC compliance and outlines precautionary measures, installation guidelines, and effects of radio equipment.
EMC Warnings and Placement Guidance
Warns about unauthorized accessories, equipment placement, and proximity to HF equipment.
EMC Equipment Interaction Warnings
Warns about unspecified accessories/cables and equipment stacking to prevent improper operation.
General Precautions
Patient Contact and Procedure Safety
Advises operator care to prevent patient contact and warns against non-specified procedures.
System Transport Safety
Instructs to push the system cart forward and avoid pulling to prevent tipping.
EMC RF Communications Distance
Recommends maintaining a minimum distance from RF communications equipment.
Overview of the Hardware
Device Description
Describes the Leica Envisu™ Spectral Domain Ophthalmic Imaging system's function and components.
Hardware Component Identification
Identifies key hardware components of the Envisu system, including the computer, engine, and probe.
Uninterruptible Power Supply (UPS)
UPS Details and Specifications
Details the Uninterruptible Power Supply (UPS) system, including its model and specifications.
UPS Status Indicators and Warnings
Explains UPS status indicators and provides critical warnings regarding grounding and power sources.
Labeling
Scan Engine and Interface Box Front Panel Labeling
Identifies and labels the controls and indicators on the front panels of the Scan Engine and Interface Box.
System Connections
Rear Panel Label Information
Details the information presented on the rear panel label, including warnings and regulatory marks.
Installation and Cable Information
Explains that connections are made by authorized personnel and lists standard system cables.
System Power Up and Power Down
System Power Up Procedure
Provides step-by-step instructions for powering up the Leica Spectral Domain Ophthalmic Imaging System.
System Power Down Procedure and Considerations
Details powering down the system, including important pre-shutdown considerations.
Troubleshooting
Resolving Hardware Problems
Provides a table to diagnose and resolve common hardware problems encountered with the system.
Troubleshooting Light Source Issues
Guides users through troubleshooting issues related to the system's light source and scanning indicators.
Troubleshooting Image Quality Issues
Helps diagnose and resolve problems related to image brightness, dimness, and overall quality.
Troubleshooting Scanning Issues
Provides solutions for common scanning problems, such as probe sounds and unidirectional scanning.
Maintenance
Maintenance Overview and Safety Checks
States no user-serviceable parts and outlines periodic safety inspections required for device integrity.
Expected Service Life and Servicing
Informs users about the expected service life of the system and when to contact for servicing.
Cleaning and Disinfecting Lenses
Cleaning Supplies and Procedure
Lists necessary supplies and provides step-by-step instructions for cleaning the handheld probe lenses.
Lens Cleaning Technique and Disposal
Details the lens wiping technique and outlines necessary actions for device disposal.
Appendix 1: Guidance and Manufacturers Declaration
Table 1: Electromagnetic Emissions
Presents a table detailing electromagnetic emissions compliance and guidance for the Envisu 2300 Model.
Table 2: Electromagnetic Immunity
Details electromagnetic immunity test levels and guidance for the Envisu 2300 Model according to IEC 60601-1-2.
Table 2: Rated Power Frequency Magnetic Field Immunity
Specifies test levels and guidance for rated power frequency magnetic field immunity.
Table 3: Conducted Disturbances and RF Fields
Provides guidance on conducted disturbances induced by RF fields and recommended separation distances.
Table 4: RF Wireless Communication Equipment Immunity
Lists test specifications for enclosure port immunity to RF wireless communication equipment.
Table 5: Recommended Separation Distances for RF Equipment
Recommends separation distances between portable/mobile RF equipment and the Envisu 2300 Model.
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