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Summary of Contents for Leica Envisu C Series
- Page 1 HARDWARE USER MANUAL Envisu C-Series SDOIS (Spectral Domain Ophthalmic Imaging System) C-Series 9054-10011 Revision N 6.2022 Envisu C-Series SDOIS / 9054-10011 / Revision N...
- Page 2 Thank you for choosing our products. We hope that you will enjoy the quality and performance of your Envisu SDOIS system. For inquiries regarding sales, service, or support contact Leica Mic system by either visiting http://www.leica-microsystems.com/service/ or by calling the One Call support number closest to your facility:...
- Page 3 Medical decision remains the responsibility of the clinician. Leica Microsystems has made every effort to provide a complete and clear user manual highlighting the key areas of product use. Should additional information regarding the use of the product be required, please contact your local Leica representative.
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Page 4: Table Of Contents
Hardware User Manual Table of Contents Contents Product Information ........................5 Symbol Key ..........................5 Intended Use & Contraindications ..................6 System Specifications ......................7 Classification .......................... 8 Warnings and Cautions ......................9 Safety ............................10 Operational Safety ......................10 Environmental Conditions ....................11 Electromagnetic Compatibility (EMC) ................12 General Precautions ......................13 Overview of the Hardware .....................14... -
Page 5: Product Information
Hardware User Manual Product Information Symbol Key The following symbols are displayed throughout the User Manual. Warning Warnings alert about situations that, if not avoided, could result in death or serious injury. Warning Dangerous Voltage Note Notes identify technical requirements to which the user should devote special attention, such as remarks on common errors, unusual situations, and tips for optimized use. -
Page 6: Intended Use & Contraindications
Hardware User Manual Intended Use & Contraindications Leica Envisu Spectral Domain Ophthalmic Imaging system is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SD-OCT). The Envisu SDOIS is indicated for use as an aid in the diagnosis of physiologic and pathologic conditions of the eye through non-contact optical imaging. -
Page 7: System Specifications
Hardware User Manual System Specifications This Document covers the following Model Numbers: Power Supply Internal Light North Europe / System Japan Source America Australia Very High Resolution C2300 9070-10024 9070-10034 9070-10097 (VHR) 31” wide x 24” deep x 37” tall to cart top Physical Dimensions (79 x 61 x 94 cm) 59”... -
Page 8: Classification
Hardware User Manual probe is 750uW. The system is compliant to IEC60825-1, Class 1 Laser. Continuous Mode of Operation Power Requirements North America: 120V, 60 Hz Europe and Australia: 185-240 Single Phase VAC, 50/60Hz, 400W max. (Not evaluated by UL) Japan: 100V, 50 or 60 Hz North America: Hospital grade NEMA 5-15 cord, 20’. -
Page 9: Warnings And Cautions
Caution! To reduce risk of electrical shock, do not open enclosure. There are no serviceable parts inside. Refer service to Leica, Inc. or its authorized agent only. Caution! Do not expose this equipment to rain or moisture. -
Page 10: Safety
Hardware User Manual Caution! Phototoxicity While no acute optical radiation hazards have been identified for direct or indirect ophthalmoscopes, it is recommended that the intensity of light directed into the subject’s eye be limited to the minimum level which is necessary for diagnosis. -
Page 11: Environmental Conditions
For product warranty by the manufacturer the following must be observed: • The device must be used according to this manual, “Leica Spectral Domain Ophthalmic Imaging System. The system should not be used in any manner aside from that specified in the user manual. -
Page 12: Electromagnetic Compatibility (Emc)
Hardware User Manual Electromagnetic Compatibility (EMC) • The Spectral Domain Ophthalmic Imaging System is in compliance with the electromagnetic compatibility requirements in accordance with EN 60601-1-2:2007 Medical Electrical Equipment-collateral standard. • The device is subject to special precautionary measures for electromagnetic compatibility: It must be installed and commissioned in accordance with the guidelines and manufacturer's declarations and recommended safety distances (according to EMC tables based on IEC 60601-1-2). -
Page 13: General Precautions
Hardware User Manual Warning! Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30cm (12 inches) to any part of the Envisu System including cables specified. Otherwise, degradation of the performance of this equipment could results Note: For electromagnetic emissions compliance information please see Appendix 1. -
Page 14: Overview Of The Hardware
< 6 microns axial resolution or better, depending on the specific model. The Leica Spectral Domain Ophthalmic Imaging System is capable of >32,000 A-Scans/second. It is composed of a host computer, SDOIS engine, probe and system cart. - Page 15 Hardware User Manual Battery Status Display Test/Silence Button On/Off Button Uninterruptible Power Supply (UPS) Medical grade PowerVAR UPS systems (UL60601-1/IEC60601-1), available in 100, 120 &230 V, 50/60 Hz, 600 VA (single-phase). Envisu C-Series SDOIS / 9054-10011 / Revision N...
- Page 16 Hardware User Manual UPM LED Display UPS Status UPM output on Battery charge status in 20% increments UPM load status in 20% increments UPM in battery operation due to improper incoming AC UPM overloaded Battery fault or battery disconnected High incoming AC: UPS has to reduce the output compared to the incoming power level Low incoming AC: UPS has to increase the output compared to the incoming power level...
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Page 17: Labeling
Hardware User Manual Labeling SDOIS Scan Engine Front Panel Reference Arm Reference Arm Position Adjust Power Adjust Power Indicator Scanning Indicator Note: The Scan Engine and Interface Box rear panels are not visible with system back panel in place. Hand Held Probe Interface Box Front Panel Power Indicator Probe Cable Envisu C-Series SDOIS / 9054-10011 / Revision N... -
Page 18: Sdois System Rear Panel Label
Cautions System Connections The Leica Spectral Domain Ophthalmic Imaging System is installed on site by authorized Leica service personnel. All electrical and optical signal connections will be secured at the time of installation. The operator will only be required to connect the system input power cord to an appropriate electrical outlet. -
Page 19: System Power Up And Power Down
System Power Up and Power Down Powering Up the System To power up the Leica Spectral Domain Ophthalmic Imaging System, use the following steps: Power on the system switch located on the front of the UPS. Check to insure the SDOIS Scan engine and Hand Held Probe interface box are powered on. -
Page 20: Troubleshooting
Plug is loose. on position. Verify plugs are installed. Fuse is blown. Contact Leica system s for support Computer does not turn on. Note: Computer will not Remove back panel; turn on automatically when reconnect the plug. - Page 21 Stop then restart the scan. delayed at the front of the software issues. Close and reopen software engine. if necessary. Contact Leica if this occurs more than once. Failsafe has disabled the Check with a wider scan. If scan because scan size is...
- Page 22 Image quality issues: There are many causes for this, some equipment, and some imaging technique. This section identifies the equipment issues only. For tips on imaging technique, contact Leica for support. To check the line spectrum, see software user’s manual, page 12.
- Page 23 Check the scan parameters to make sure that “inactive too small on the scan scans” is set to at least 50. parameters. Damage to scanning Contact Leica mirrors. system s for support Scan only works in one Cables between SDOIS Contact Leica direction.
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Page 24: Maintenance
If any problems are observed, please call customer service for further assistance. Expected Service Life The Expected Service Life of the system is 10 years. After 10 years, please contact Leica to arrange for further servicing. Envisu C-Series SDOIS / 9054-10011 / Revision N... -
Page 25: Cleaning And Disinfecting Lenses
Hardware User Manual Cleaning and Disinfecting Lenses: To clean the handheld probe lenses, obtain the following supplies: • Powder free latex or nitrile gloves • lint-free lens tissue (a nonwoven rayon blend is recommended) • Reagent-grade methanol or isopropyl alcohol Follow these steps to clean the lens: 1. -
Page 26: Disposal
Disposal Several actions must be done before the device may be disposed of. 1. Notify Leica that the device will be disposed. 2. Remove all personal files, videos, e-mails, and pictures from the computer. 3. Format the hard drive by using the system restore disc to return the system to its original state. - Page 27 Appendix 1 Appendix 1: Guidance and Manufacturers Declaration Table 1 - Electromagnetic Emissions The Envisu 2300 Model is intended for use in the electromagnetic environment specified below. The customer or the user of the Envisu 2300 Model should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance...
- Page 28 Appendix 1 Table 2 - Electromagnetic Immunity The Models Envisu 2300 is intended for use in the electromagnetic environment specified below. The customer or the user of the Envisu 2300 Model should assure that it is used in such an environment. IEC 60601-1-2 Electromagnetic environment IMMUNITY test...
- Page 29 Appendix 1 The Models Envisu 2300 is intended for use in the electromagnetic environment specified below. The customer or the user of the Envisu 2300 Model should assure that it is used in such an environment. IEC 60601-1-2 Electromagnetic environment IMMUNITY test test level guidance...
- Page 30 Appendix 1 Table 3 - Electromagnetic Immunity The Envisu 2300 Model is intended for use in the electromagnetic environment specified below. The customer or the user of the Envisu 2300 Model should assure that it is used in such an environment. IMMUNITY test IEC 60601-1-2 TEST Electromagnetic environment guidance...
- Page 31 Appendix 1 Table 4 – Test Specifications for Enclosure Port Immunity to RF wireless communication equipment Test frequency Band Maximum Distance Immunity Service Modulation (MHz) (MHz) Power (W) Test Level Pulse 380-390 TETRA 400 Modulation 18Hz FM +/- 5kHz GMRS 460, 430-470 deviation FRS 460...
- Page 32 Appendix 1 Table 5 - Recommended separation distances between portable and mobile RF communications equipment and the Envisu 2300 Model The Envisu 2300 Model is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Envisu 2300 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Envisu 2300 as recommended below, according to the maximum output power of the communications equipment.
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