ALCON LuxOR Revalia LX3 LED Operator's Manual

Ophthalmic microscope with q-vue 3d assistant visualization

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LuxOR Revalia™ (LX3 LED) Ophthalmic Microscope

LuxOR Revalia™ (LX3 LED) Ophthalmic Microscope with

NOTES:

1. Inspect per Generic QIP Manual.

2. Safety critical component.

3. This drawing contains a total of 1 Control Dimension Number. 0

4. If only text is ordered, shrink wrap pages with cardboard backing.

Gerard Scortino

CHECKED

Troy Hinzman

APPROVED

Asheesh Sah

TEXT FOR

Q-VUE™ 3D Assistant Visualization

Operator's Manual

DATE

14-Mar-2019

IRVINE, CA 92618-3818

14-Mar-2019

REVISIONS

REV

And

CN/ECN #

CN083418ECN

CN002684ECN

CN097181ECN

CN100243ECN

CN104580ECN

CN105842ECN

SHEET 1 of 137

TITLE

TEXT, MANUAL, OPER,

LUXOR REVALIA

DWG NO.

300027261-001

Date

27-MAR-2019

12-APR-2019

15-NOV-2019

15-MAY-2020

26-APR-2021

28-JUN-2021

REV

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Summary of Contents for ALCON LuxOR Revalia LX3 LED

Page 1 REVISIONS CN/ECN # Date CN083418ECN 27-MAR-2019 CN002684ECN 12-APR-2019 CN097181ECN 15-NOV-2019 CN100243ECN 15-MAY-2020 CN104580ECN 26-APR-2021 CN105842ECN 28-JUN-2021 TEXT FOR LuxOR Revalia™ (LX3 LED) Ophthalmic Microscope LuxOR Revalia™ (LX3 LED) Ophthalmic Microscope with Q-VUE™ 3D Assistant Visualization Operator’s Manual NOTES: 1. Inspect per Generic QIP Manual. 2.
Page 2 Produced By: Alcon Research, LLC. 15800 Alton Parkway Irvine, California 92618-3818 www.ifu.alcon.com U.S.A. Telephone: 949/753-1393 US Toll Free 800/832-7827 © 2018, 2019, 2020, 2021 Alcon Inc. 300027261-001 Rev. F Text Only 8065000004 Rev F Catalog Number Issued Date: 27 Jul 2021...
Page 3: Front Matter
LuxOR Revalia™ (LX3 LED) Ophthalmic Microscope Operator’s Manual 8065000004 FRONT MATTER Manual Revision Record DATE REVISION CN NUMBER/DESCRIPTION 27-MAR-2019 CN083418ECN - Initial Release 12-APR-2019 CN002684ECN - Updated warnings, removed intended use environments, updated accessory list. 15-NOV-2019 CN097181ECN - Added LED module information, updated product description, and changed the EC REP address.
Page 4: Incident Reporting
Incident Reporting Any serious incident related to the use of this medical device should be report to Alcon Laboratories, Inc. Contact information: By Phone: In USA – (800) 757-9780 International: Contact the local country office or your Alcon distributor. By website –...
Page 5 This page intentionally left blank 8065000004 Rev. F...
Page 6: Table Of Contents
Table of Contents FRONT MATTER ........PAGE # Manual Revision Record .
Page 7 Touch Screens ............2.14 The Main Screen on the Primary Control Panel .
Page 8 SECTION FOUR - CARE AND MAINTENANCE ....PAGE # General Cleaning and Protection ........Transport and Storage .
Page 9: Preface
Preface This operator’s manual is your written guide to the LuxOR Revalia™ (LX3 LED) Ophthalmic Microscope and LuxOR Revalia™ (LX3 LED) Ophthalmic Microscope with Q-VUE™ 3D Assistant Visualization, and considers all options available to the customer; therefore, when reading this manual, ignore the options which do not apply to your specific unit.
Page 10: Product Service
Return Material Authorization (RMA) will be issued with appropriate shipping instructions. Technical Services Department If you have questions, or want additional information, please contact your local Alcon representative or the Alcon Technical Services Department at: Alcon Research, LLC.
Page 11: Limited Warranty
Alcon, and any warranties provided by Alcon with respect to this equipment shall become void and of no further force and effect if this equipment is serviced by anyone other than service personnel authorized by Alcon.
Page 12: Section One - General Information
SECTION ONE - GENERAL INFORMATION Product Description The LuxOR™ Ophthalmic Microscope System is an ophthalmic surgical instrument used for visualization and illumination of the eye during ophthalmic surgery. The microscope system is intended for low magnification visualization during ophthalmic surgical procedures, including: cataract, retinal, and corneal procedures. The Q-VUE™...
Page 13: Intended Use(S)
Intended Use(s) The LuxOR™ Ophthalmic Microscope is designed for use in the operating room during ophthalmic surgeries such as: cataract, refractive, glaucoma, and plastic surgery The LuxOR™ Ophthalmic Microscope is intended to assist the surgeon in viewing the eye during posterior and anterior ophthalmic surgery. This is accomplished by means of providing adjustable illumination, magnification and focus.
Page 14: Safety Notes On Use And Installation
• Modifications and repairs on this equipment may only be performed by service personnel authorized by Alcon. • The manufacturer will not accept any liability for damage caused by unauthorized persons tampering with the equipment; this will also forfeit any rights to warranty claims.
Page 15: Before Every Use Of The Instrument
Before Every Use of the Instrument • Make sure the articulating arm to which the LIBERO-XY™ system is attached is properly balanced in the use position. • Make sure the suspension system (LuxOR Revalia™ (LX3 LED) Floor Stand) to which the LIBERO-XY™ system is attached has no damaged casters (if applicable).
Page 16: Luxor Revalia™ (Lx3 Led) Microscope System Warnings
LuxOR Revalia™ (LX3 LED) Microscope System Warnings • Observe these and all other safety precautions for the LuxOR Revalia™ (LX3 LED) microscope system, as they still apply. WARNINGS! • Prolonged exposure to the microscope light may be harmful to the eye. The maximum safe eye exposure at maximum level of illumination is 32 minutes.
Page 17: Footswitch
Footswitch If required, the footswitch may be wiped with mild soap and water, or any germicidal solution that is compatible with the plastic parts. WARNINGS! • If footswitch is used in wired configuration, route cable properly to avoid tripping. • Footswitch battery can only be serviced or replaced by factory-trained service engineer.
Page 18: Phototoxicity
Phototoxicity During exposure to light from the instrument, do not exceed the hazard reference values. For this instrument operated at 175 mm working distance, an exposure time of over 32 minutes at maximum output power may exceed the hazard reference value. WARNING! Prolonged exposure to the microscope light may be harmful to the eye.
Page 19 Special operating conditions should be applied when performing corneal transplantation. When considering corneal transplantation, different assumptions must be used when determining maximum light exposure limits. These worst case assumptions include: • Completely unmoving eye (continuous radiation of the same region) •...
Page 20: Warnings And Cautions
• A qualified technician must perform a visual inspection of the following components every twelve months: • Warning Labels, • Power Cord, • Fuses. • In case of a deficiency, do not use the system; call Alcon Technical Services. • A qualified technician must check ground continuity and leakage current every twelve months to ensure they are within the limits of the applicable standards (for example: IEC60601-1).
Page 21 • Use of accessories other than those manufactured by Alcon may affect system performance and create potential hazards. If it is determined that...
Page 22: Transport Warning
If you need to transport your unit to an off-site location or have immediate concerns about your unit, contact Alcon Technical Support for assistance. (LX3 LED) Figure 1–1 LuxOR Revalia™...
Page 23 CAUTIONS • Modification of the equipment is NOT allowed without prior authorization from the manufacturer. If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment. • Do not push or pull unit by the display, optical carrier, or binoculars. The unit should be pulled and not pushed using the handles on the floor stand, especially over elevator and door thresholds.
Page 24: User Information - Environmental Considerations
Operator’s Manual. Please use the appropriate take-back systems. Such take-back systems reuse or recycle many of the materials in your end-of-life equipment in a beneficial way. Please contact your local Alcon office for assistance in take-back options through Alcon or other providers.
Page 25: Accessory Equipment Warnings
IEC Standard (e.g., IEC 60950-1 for data processing equipment, and IEC_60601-1 for medical equipment). Anyone connecting additional equipment or otherwise causing a different system configuration than provided by Alcon is responsible for continued compliance to the requirements of System Standard IEC 60601-1. If in doubt, consult the Technical Services department or your local Alcon representative.
Page 26: Electromagnetic Compatibility (Emc) Compliance
• Connect this equipment into an outlet on a circuit different from that to which the other device(s) is connected. • Consult the manufacturer or your Alcon field service engineer for help. Table 1–3 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The LuxOR Revalia™...
Page 27 Table 1–4 Guidance and Manufacturer's Declaration - Electromagnetic Immunity The LuxOR Revalia™ (LX3 LED) Microscope is Intended for use in the Electromagnetic Environment Specified Below. The Customer or the User of the System Should Assure That it is Used in Such an Environment. Immunity IEC 60601 test level Compliance level...
Page 28 Immunity IEC 60601 test level Compliance level Electromagnetic test environment – guidance Radiated RF 3 V/m 3V/m The dwell time should be at least 1 s and should be no less than the response time of the IEC 61000-4-3 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz slowest responding function plus the setting time of the...
Page 29: Equipment Contains Radio Transmitters
(2) this device must accept any interference received, including interference that may cause undesired operation. CAUTION Change or modifications made to this equipment (including antenna) not expressly approved by Alcon may void the FCC authorization to operate this equipment. 8065000004 Rev. F 1.18...
Page 30 FCC Radiation Exposure Statement WARNING! To ensure that the radio transmitter complies with current FCC regulations limiting both maximum output RF power and human exposure to radio frequency radiation, a separate distance of at least 20 cm must be maintained between the unit’s antenna and the body of the user and any nearby persons at all times, and unit’s antenna must not be co-located or operating in conjunction with any other antenna or transmitter.
Page 31 Canada – Industry of Canada (IC) This device complies with Industry Canada license-exempt RSS standards. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.
Page 32: Summary Of Luxor Revalia™ (Lx3 Led) Wireless Certifications
Summary of LuxOR Revalia™ (LX3 LED) Wireless Certifications United States Canada FCC ID: VMCNGPFSW1 IC: 7345A-NGPFSW1 Contains FCC ID: RI7XE61 Contains IC: 5131A-XE61 Korea Taiwan CCAB15LP4060T3 MSIP-CRI-TCS-XE61-24 CCAB15LP4050T0 R-R-Alc-LX3 Europe Australia CE Mark to MD and RED Directives Brazil Japan 209-J00129 8065000004 Rev.
Page 33: Specifications
Specifications Table 1–5 Specifications Height: No greater than 183 cm (72 inches) Width Across Base: • No greater than 92 cm (36 inches) Dimensions - • No greater than 83.5 cm (33 inches) with casters turned inside base Microscope with Stand Depth: No greater than 125 cm (50 inches) with the arm folded and overall reach of minimum 125 cm (50 inches) from the center of the...
Page 34 ˚ ˚ ˚ 35.5” (903 mm) 16.2” (412 mm) ˚ A+B+C = 360 71.42” (1814 mm) 62.2” (1580 mm) 36.1” (917 mm) Figure 1–2 Dimensions and Swivel 81.5” (2070 mm) Figure 1–3 Height Dimensions 8065000004 Rev. F 1.23...
Page 35 49.98” (1270 mm) 81.5” (2070 mm) Figure 1–4 Dimensions in Folded Position 34.8” DIA (883.92 mm) 32.5” (825.5 mm) ˚ ˚ to -90 Nominal Figure 1–5 Base Foot Print and Microscope Tilt 8065000004 Rev. F 1.24...
Page 36: Icons
Icons Table 1–6 Icon Definitions Icons That are Used on the System are Identified in This Chart. The Icons Shown on This Page are for Reference Only. Follow Instructions For Use Catalog Number (White Figure On Blue Background) Warning, Electricity Global Trade (Black Symbols On Yellow Identification Number...
Page 37 Earth Ground CE Mark Use Appropriate Take- Back System (See Environmental Equipotential Ground Considerations In This Connection Manual) Pb Notation, If Present, Indicates Lead Content Greater Than 0.004%. Warning: For Continued Protection Against Risk Of Certification Mark For Fire, Replace Only With Japanese Radio Law Same Type And Rating Of Fuse.
Page 38: Labels
Labels Unique Device Identifier label Identification label FCC Wireless label Footswith label located on bottom of footswitch (LX3 LED) Figure 1–6 Labeling on LuxOR Revalia™ System and Footswitch Refer to the labels on your system for applicable system information. 8065000004 Rev. F 1.27...
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Page 40: Section Two - Description
SECTION TWO - DESCRIPTION System Description The LuxOR Revalia™ (LX3 LED) Ophthalmic Microscope System is comprised of the following components: Articulating Arm Primary Control Panel and User Interface LIBERO-XY Communication System LuxOR Revalia™ (LX3 LED) Q-Vue Ophthalmic Microscope 3D Assistant Visualization System ILLUMIN-i Technology...
Page 41 The LuxOR Revalia™ (LX3 LED) Ophthalmic Microscope System provides an X-Y coupling and control unit with a limited range of motion. A foot control is used in conjunction with the microscope system as a convenience to the surgeon. Users are provided options to control X-Y motion, focus, and magnification of the optical head, as well as the illumination functions of an illuminator module in LED light options.
Page 42: Turning On The Luxor Revalia™ (Lx3 Led)
Head Rotation Friction Adjustment Knob Primary Control Panel and User Interface LIBERO-XY Connector Panel LuxOR Revalia (LX3 LED) Ophthalmic Microscope Standby Power Switch Hanger for Footswitch Power Cable Wrap LX3 Footswitch Charging Station for LX3 Footswitch LX3 Power Module and Connector Panel Figure 2–3 LuxOR Revalia™...
Page 43: Power Module
• Primary AC Power Switch - Connects AC power to power supply. • Fuse Door - Open the fuse door to gain access to the fuse holder. Contact Alcon Technical Services for the correct rating and size. Figure 2–4 LuxOR Revalia™ (LX3 LED) Power Module and Connector Panel Table 2–1...
Page 44: Libero-Xy™ Connector Panel
LIBERO-XY™ Connector Panel This connector panel is located behind the LIBERO -XY™ The two connectors identified on the right are outputs to the ILLUMIN-i™ lamp and motor drivers. The first connector on the left is used for the optional BIOM** feature. Figure 2–5 LIBERO-XY™...
Page 45: Theory Of Operation
Theory of Operation LuxOR Revalia™ (LX3 LED) Ophthalmic Microscope Designed as a fully-integrated ophthalmologic microscope system, the LuxOR Revalia™ (LX3 LED) System synchronizes with the precision optics of the LuxOR Revalia™ microscope. The microscope features a motorized zoom barrel (4:1 with automatic reset) and focus drive (30 mm travel with automatic reset) which is controlled via the footswitch.
Page 46: Luxor Revalia™ (Lx3 Led) Microscope With Q-Vue™ 3D Assistant Visualization
LuxOR Revalia™ (LX3 LED) Microscope with Q-VUE™ 3D Assistant Visualization The Q-VUE™ microscope is a true stereo co-observation system with independent 5-step magnification control (Figure 2–7). This feature allows a co-observer to view the procedure from either side of the primary surgeon in true stereoscopic vision without light loss to the primary surgeon’s view.
Page 47: Optics Accessories
Optics Accessories Accessory components can be added onto the LuxOR Revalia™ (LX3 LED) microscope, and after stacking what can be many components, the articulating arm must be re- balanced in the use position to compensate for the added weight. Then, to avoid inadvertent patient contact during surgery, the lower limit safety stop must be adjusted.
Page 48: The Footswitch
The Footswitch The LuxOR Revalia™ (LX3 LED) system operates with the LX3 Footswitch (Figure 2–10). All functions of the microscope can be controlled with the footswitch (see, ”Menu / Doctor Settings / Footswitch Tab” on page 2.33 of this manual for programming instructions).
Page 49: Footswitch Hanger / Charging Station
Footswitch Hanger / Charging Station When out of use, the footswitch hangs on the back of the floor stand. If used wirelessly, its internal battery is charged through the surface of the charging station. If wired to the LuxOR Revalia™ microscope, and system power is turned on, the footswitch battery is charged through the cable.
Page 50 To successfully charge wireless footswitch on cradle: • Ensure the footswitch skin is flush with the console skin when cradled. • There are no battery-related alerts. • If footswitch is cabled and placed on the cradle, it will wirelessly charge when console is OFF.
Page 51: Footswitch Battery Charge Status Indicator
Footswitch Battery Charge Status Indicator One of the following is displayed to the right of the footswitch button: • If the footswitch battery is not low and not charging, a bar graph with 3 green segments. • If the footswitch battery is low and not charging, a bar graph with 2 yellow segments.
Page 52: The Electromechanical Clutches
The Electromechanical Clutches The LuxOR Revalia™ (LX3 LED) floor stand is equipped with three electromechanical clutches designed to lock the microscope in the doctor’s preferred position. One is between the rolling base and floor stand, one is between the floor stand and articulating arm, and the third locks the articulating arm’s vertical movement (Figure 2–1).
Page 53: Touch Screens
Touch Screens The main user interface is the LuxOR Revalia™ (LX3 LED) Primary Control Panel (Figure 2–14); doctor selection and system controls through the MENU function are performed on this touchscreen. The LIBERO-XY™ Remote Communication System is driven by the LuxOR Revalia™ (LX3 LED) Primary Control Panel. Both screens allow the user to turn the light ON/OFF and adjust Light Intensity.
Page 54: The Main Screen On The Primary Control Panel
Figure 2–16 Startup Screen System power-up is initiated when the Standby Switch is pressed. After some delay (during which the BIOS displays its splash screen) the Startup Screen is displayed. During power-up the following are displayed on the Startup Screen: •...
Page 55: Surgery Screen - Led Illuminator Module
Surgery Screen - LED Illuminator Module Figure 2–17 Surgery Screen {LED Illuminator Module} Table 2–6 Surgery Screen Illuminator Module Functions Item Description Doctor Button Light Intensity Pupillary Distance Focus Reset Focus Position MAG Reset Wireless Connection to Centurion™ Vision System Light Preset RESET All (Focus, MAG, X-Y Target, LIGHT Intensity) X-Y Target and Reset...
Page 56 The LED Illuminator Module provides two sources of illumination supplied by light emitting diodes (LEDs): Coaxial and Oblique. The Coaxial and Oblique illumination can be controlled separately or in tandem. Figure 2–18 Coaxial Only Illumination, Balance is Greyed out (not Available) Figure 2–19 Oblique Only Illumination, Balance is Greyed out (not Available) The light intensity value is displayed as a percentage 0-100%.
Page 57 Figure 2–20 Coax and Oblique in Tandem, (“Light” Mode) Balance set to 100% Oblique Figure 2–21 Coax and Oblique in Tandem, (“Light” Mode) Balance set to 100% Coax 8065000004 Rev. F 2.18...
Page 58 Table 2–8 Surgery Screen – LED Illuminator Module Display Object Description Displays the Current Doctor or Alcon Settings if there are Doctor Button no user-defined doctors. When pressed, displays the Select Doctor Dialog. Displayed upon a general alert. When pressed, opens the Alert Information Dialog.
Page 59 (Table 2-8 Continued) Display Object Description Cycles through each of the illumination control modes with button text changing to reflect the current illumination control mode as follows: Illumination Control Mode “COAX”= Coaxial Illumination Control Mode Button “OBLIQ”= Oblique Illumination Control Mode “LIGHT”= Concurrent Coaxial/Oblique Illumination Control Mode Increases illumination intensity in 5% increments.
Page 60 (Table 2-8 Continued) Display Object Description Decreases illumination intensity in 5% increments. Illumination Control Mode Button Illumination decrease is dependent on the Illumination Control Mode Button selection: COAX = Coaxial Illumination Control Mode Decrease Coaxial illumination whether Coaxial LED is on or off.
Page 61 (Table 2-8 Continued) Display Object Description The number of bars illuminated is indicative of the illumination intensity setting at approximately 5% per bar. When illumination is off none of the bars are illuminated. Illumination Control Mode Button Illumination readout is dependent on the Illumination Control Mode Button selection: COAX = Coaxial Illumination Control Mode Illumination Intensity Bar...
Page 62 (Table 2-8 Continued) Display Object Description The Illumination Balance Control comprises the Coaxial Balance Button, the Oblique Balance Button, Balance Slider, Balance Track Bar, and Balance Value Readout. Balance and Illumination • The center of the position setting of the Illumination Balance Control provides equal values of Coaxial and Oblique illumination and is set to equalize to the largest of either...
Page 63 (Table 2-8 Continued) Display Object Description The position of the Balance Slider reflects the Balance value: Center = 0 Balance Slider Left Limit = -100 Right Limit = +100 The Balance Slider can be dragged to adjust the Balance value in increments of 5. The Balance Track Bar represents the selection range of the Balance values between -100 and +100 with 0 at the center.
Page 64 (Table 2-8 Continued) Display Object Description After pressing the Light Preset Button, displays the name Light Preset Readout of the selected preset for 5 seconds: “Default” “Preset 1” “Preset 2” Resets the illumination intensity, zoom (magnification), and focus to the Current Doctor’s default programmed settings in the Doctor Settings Dialog –...
Page 65: Fault Screen
(Table 2-8 Continued) Display Object Description Panel PC Brightness Bar The number of bars illuminated is indicative of the Panel PC Readout display brightness. Fault Screen Figure 2–22 Fault Screen The Fault Screen Title displays the System Fault Code. The Body of the Fault Screen displays the name of the fault and the recommended actions.
Page 66: Current Doctor
Current Doctor To select a Surgeon with all of his preferences, press the Current Doctor button at the top of the screen. A list of Doctors appears (Figure 2–23) Select a doctor name on the list and press its button. The Main screen reappears with all the doctor’s preferred settings. Doctors can be added and removed via the MENU/Manage Doctors feature.
Page 67: General Warning
General Warning This yellow triangular button appears on the left side of the main screen and Libero when an issue occurs that can affect the performance of the microscope. Press the button on the main screen to read an explanatory message. Press the red X button to return to the main screen.
Page 68: Focus
Focus Pressing this button resets focus to the doctor’s programmed settings. Reset Pressing the RESET button restores LuxOR Revalia™ (LX3 LED) microscope settings to the doctor’s programmed settings (Light Intensity, X-Y, Focus, Zoom magnification). X-Y Target Through the course of a surgery the microscope may be moved in the X-Y horizontal plane with the footswitch joystick or MENU/Controls dialog.
Page 69: Custom Menu
• Doctor Settings - This is where the user can set all of the user preferences for the current doctor (General, Optics, Footswitch, Display and Reset). The settings cannot be changed when the current doctor is Alcon Settings. Attempting to save changes made in Alcon Settings prompts user to create a new doctor; otherwise, select or create a new doctor by pressing Manage Doctors and make changes to the new doctor.
Page 70: Menu / Doctor Settings
• XY Speed - Motor speed setting when adjusting XY position. Figure 2–26 Doctor Settings - General Tab If Alcon Settings is the selected doctor, pressing the green check button causes the Save Doctor As dialog to appear; the user can save the new default settings with a new doctor name.
Page 71: Menu/Doctor Settings Optics Tab
Menu/Doctor Settings Optics Tab Selecting the Optics tab opens a screen where the user identifies the type of Eye Piece, Binocular, Lens Objective, and Camera Scene used in the microscope. These settings, along with the Magnification Coefficient, are used to calculate true magnification (for reference only).
Page 72: Menu / Doctor Settings / Footswitch Tab
Menu / Doctor Settings / Footswitch Tab The footswitch contains twelve control switches. The current doctor can change the function of each switch for personal preference by pressing the number of the switch to be changed and selecting the desired function from a dialog that appears; press the green check button to accept the change.
Page 73: Menu / Doctor Settings / Reset Tab
Menu / Doctor Settings / Reset Tab On this tab, the user can configure whether the Light turns OFF or not when RESET is executed. • Yes – Light turns off when RESET is executed. • No – Light does not turn off and the light intensity is reset to the default value when RESET is executed.
Page 74: Menu / System Settings / General Tab
Menu / System Settings / General Tab The second selection in the Custom menu is System Settings. Pressing the System Settings button brings up the System Settings/General tab dialog (Figure 2–32). The user can set the local Date and Time by pressing the Change button. A dialog appears where the settings can be changed to the local date and time.
Page 75: Menu / Manage Doctors
Menu / Manage Doctors The user can add, rename, remove, back up, and restore doctors on the Manage Doctors dialog screen, accessed by pressing the MENU button and selecting Manage Doctors. When done with any of these procedures, press the red X button to return the main screen. To create a new doctor name, press the New Doctor button.
Page 76: Menu/Wireless Settings
Figure 2–34 Manage Doctors Dialog Screen Menu/Wireless Settings The Wireless Settings dialog is used to select settings that allow the LX3 wireless footswitch to communicate to the microscope, and the microscope to communicate wirelessly with the Centurion™ system. Note that after settings are changed, the wireless footswitch must be paired again.
Page 77 This dialog appears when the Mode selection is turned Off. The Channel and Region selections appear when Standalone is pressed (Figure 2–36). When Paired is selected, the Pair with Centurion™ button occupies that space. • Mode - These three Mode selections determine whether or not the microscope will be operated wirelessly.
Page 78 NOTE: The Region setting establishes the transmit power level associated with a particular region and should not be changed once established for the region of use. Please contact your Alcon Technical Service Representative for information regarding applicable restrictions. 8065000004 Rev. F...
Page 79: Menu / Controls
The View Events dialog lists the date/time of events that may have compromised the performance of the LuxOR Revalia™ (LX3 LED) microscope. This list of events can be helpful when speaking with an Alcon support representative. This dialog appears when the Menu/View Events button is pressed.
Page 80: Menu / About
Menu / About System software and hardware used in the microscope, along with its serial number and date of manufacture, are listed here. Press the Patents button to see Alcon patents on this product. Figure 2–39 About Dialog Menu / Shutdown Open this window to safely turn system power OFF.
Page 81: Light On/Off And Light Intensity
Light ON/OFF and Light Intensity In the center of the main screen is the Light ON/OFF button (Figure 2–41). When the illuminator light on the ILLUMIN-i™ Technology is ON, the blue LIGHT Intensity bars are illuminated and the light intensity % readout is white. The number of blue bars illuminated is indicative of the light intensity setting.
Page 82: Focus Setting
Focus Setting In the center of the main screen is the FOCUS button (Figure 2–42). Focus can be set using the footswitch or pressing the buttons in the MENU/Controls dialog. The blue bars displayed indicate the relative position of focus; there is no percentage readout for the setting.
Page 83: External Monitor
(Alcon logo on a black background). In this scenario the console should be powered OFF using the Standby button and the user should wait for the monitor to stop scanning inputs (most monitors enter a power saving mode or turn OFF after a few scans).
Page 84: Recommended Power Up Sequence For External Monitor
The following power up sequence for the external monitor must be followed. If not powered up as written, the LuxOR Revalia™ (LX3 LED) console may not power up correctly, or the monitor may not function as expected. Recommended Power up Sequence for External Monitor 1.
Page 85: Internal And External Cameras And Monitors
Internal and External Cameras and Monitors The internal camera is an upgrade installed by Alcon tech service. There are two options: 1MOS and 3MOS. The same camera with a different catalog number can be installed as an external video system by the user.
Page 86: Section Three - Operating Instructions
SECTION THREE - OPERATING INSTRUCTIONS This section gives instructions to set up the LuxOR Revalia™ (LX3 LED) system for use. In this section you will learn to set up each user’s preferences and prepare for surgery. Instructions are also included to set up the articulating arm. Setting Up the LuxOR Revalia™...
Page 87 After the boot up routine the system enters its last-used settings on the Main screen of the LX3 Primary Control Panel (Figure 3–2). An abbreviated Main screen appears on the LIBERO-XY™ Communication System (Figure 3–3). The system is now ready for use. Figure 3–2 Main Screen on LX3 Primary Control Panel Figure 3–3 Main Screen on LIBERO-XY™...
Page 88: Using The Menu Button
Using The Menu Button 1. Menu - On the LX3 Primary Control Panel, press the MENU button (Figure 3–2).The Custom menu appears in the lower-left corner (Figure 3–4). Figure 3–4 The Custom Menu 2. Doctor Settings - To access the current doctor’s preferred settings, press the Doctor Settings button on the Custom menu (Figure 3–4).
Page 89 Figure 3–6 Doctor Settings - Optics Tab Figure 3–7 Doctor Settings - Footswitch Tab Figure 3–8 Doctor Settings - Display Tab 8065000004 Rev. F...
Page 90 Figure 3–9 Doctor Settings - Reset Tab 3. System Settings - Use the MENU button, to access the System Settings button. The System Settings screen appears (Figure 3–10). The user can set the local Date and Time by pressing the Change button. A dialog appears where the settings can be changed to the local date and time.
Page 91 Figure 3–11 System Settings - General Tab/Camera Settings. Pressing the Camera/Installed button brings up the Camera Model dialog where the installed camera can be selected with the up/down buttons. 4. Manage Doctors - Press Manage Doctors. The Manage Doctors dialog appears (Figure 3–12).
Page 92 Figure 3–13 Keyboard - New Doctor Name is Typed Into Text box Figure 3–14 The Main Screen - Dr. Robert Obo Replaces Dr. Maurice Dedo 8065000004 Rev. F...
Page 93: Video Overview
Video Overview Alcon’s LuxOR Revalia™ (LX3 LED) Microscope is capable of several video functions. It can display live video from an internal or external camera with video overlay from a Centurion™ surgical system. The surgery can be recorded onto a USB NTFS memory stick, and then the recorded video can be played back on the Primary Control Panel.
Page 94 3. To view live video in a large format filling the screen, press the Expand button in the lower-right corner of the small display; the live video expands to fill the whole display (Figure 3–16). Playback button Video Camera button Minimize button Start Recording button (REC) Progress bar...
Page 95 9. Playback Recorded Video -From the large video window press the Playback icon button to open the Playback screen (Figure 3–17). Videos recorded onto the memory stick are displayed in the right column. Select a video and press the Start button; the video is displayed on the screen and the Playback button icon turns blue.
Page 96 10. Controls - Press the MENU button, then the Controls button. The Controls dialog appears (Figure 3–18). The user can use this control panel to make real-time adjustments to the microscope’s viewing settings. These controls are also available through the footswitch’s joystick and button switches.
Page 97: Set White Balance
The View Events dialog lists the date/time of events that may have compromised the performance of the LX3 microscope. This list of events can be helpful when speaking with an Alcon support representative. Figure 3–19 View Events Dialog This dialog appears when the MENU/View Events button is pressed.
Page 98: About
About Access the About screen by, pressing the MENU button, then the About button. The About dialog appears (Figure 3–20) System software and hardware used in the microscope, along with its serial number and date of manufacture, are listed here. Press the red X button to exit the dialog and return to the Main screen.
Page 99: Prepare For Surgery
• In case of any deficiency or concern with the microscope system or function, do NOT use the system. Contact the Alcon Technical Services Department at (949) 753-1393 or (800) 832-7827.
Page 100: Balance The Articulating Arm
Balance the Articulating Arm After adding or removing optics and component accessories (BIOM**, ORA, video camera, assistant’s scope) onto or from the articulating arm, it must be balanced in the use position for ease of vertical movement. WARNINGS! • All optical components must be connected to the microscope (BIOM**, ORA, video camera, assistant’s scope) prior to balancing the articulating arm.
Page 101 Figure 3–22 Arm Balance - Use hex Wrench to Balance the Articulating arm. 8065000004 Rev. F 3.16...
Page 102: Set The Lower Limit Safety Stop
Set the Lower Limit Safety Stop To avoid inadvertent patient contact during surgery, adjust the articulating arm’s lower limit safety stop adjustment knob so that the bottom of the microscope/accessories cannot contact the patient when the arm is lowered to its minimum height. 1.
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Page 104: Section Four - Care And Maintenance
SECTION FOUR - CARE AND MAINTENANCE General Cleaning and Protection External microscope lens surfaces of optical components (eyepieces, objectives) should be cleaned on a regular basis: • Remove dust with a squeeze blower, pressurized air, or a grease-free brush. • Low Profile Eye cup shall withstand wiping with a dry or damp cloth with a mild detergent solution, and/or a germicidal wipe solution, and/or alcohol.
Page 105: Transport And Storage
If you need to transport your unit to an off-site location or have immediate concerns about your unit, contact Alcon Technical Services for assistance. Figure 4–1 LuxOR Revalia™ (LX3 LED) System in Folded Transport Position...
Page 106: Cleaning/Sterilization Of Reusable Knob Covers
Both manual cleaning and automated wash procedures are presented. WARNINGS! • If a knob cover is received in a defective condition, do not use. Notify Alcon immediately. • Knob covers are provided as non-sterile units and must be cleaned and sterilized prior to use.
Page 107: Manual Cleaning Procedure
Manual Cleaning Procedure 2. Remove knob covers from module immediately after use. 3. Promptly clean any visible debris using sterile lint-free wipes moistened with 70% IPA. Alternately, distilled water may be used initially with lint-free wipes, and then followed by sterile lint-free wipes moistened with 70% IPA. 4.
Page 108 4. Program washer to have the following automated cycle: • Main wash at 55 °C for 10 minutes (dispense detergent as recommended by detergent and washer manufacturer) • Set neutralizer for a minimum of 1.5 minutes (dispense neutralizer as recommended by detergent and washer manufacturer) •...
Page 109: Sterilization Procedure
Sterilize the knob covers using a steam sterilization cycle. The sterilization settings provided in (Table 4–1) have been validated by Alcon Laboratories, Inc. as being capable of sterilizing the instruments for re-use. It remains the responsibility of the processor to ensure that the processing as actually performed using equipment, materials, and personnel in the facility will provide clean sterile covers.
Page 110: Removing And Replacing Led Illuminator Modules
Removing and Replacing LED Illuminator Modules NOTE: Pay close attention to these instruction to avoid damage to the connector or other parts of the system. The LED modules are available in various color temperature options (“Table 6–1 Accessories and parts” on page 6.2 Figure 4–3 LED Module Color Temperature Options LED module (sticker identifies LED color as warm white)
Page 111 CAUTION Do not touch the LEDs or printed circuit board with bare hands as it will negatively impact system performance. 3. When installing or replacing, the LED module onto the Illumin-I, ensure the module engages the Illumin-I with mounting faces parallel; avoid tilting the module in any direction.
Page 112 5. Once properly aligned, seat the module by pushing all the way in against the Illumin-I. 6. Once fully engaged, lock the module in place with the two thumbscrews, tightening in equal increments, a little at a time until both thumbscrews are tight, so the lamp properly engages flush to the Illumin-I.
Page 113: Fuse Replacement
The fuse door must be pressed gently to ensure it does not break. 3. With fuse door open, grasp the fuse holder and pull it out from the power module. 4. Gently remove and replace fuses. Contact Alcon Technical Services for the correct rating and size.
Page 114: Section Five - Troubleshooting
LuxOR Revalia™ microscope. In all cases, should the corrective actions not provide the desired result, call Alcon Technical Services. NOTE: The microscope can be powered off at any time by pressing and holding the Standby power button on the side of the LX3 floor stand for at least ten seconds.
Page 115: Fault
Fault: XXX Unit displays an event code and Follow the advisories troubleshooting message.
Page 116 When an Event is encountered, refer to Table 5-1 first. Table 5–1 Observed Conditions Listed in this table are observed conditions that may be presented to the user. The observed Symptom is followed by the Probable Cause and its Corrective Action.(s). OBSERVED CONDITIONS SYMPTOM PROBABLE CAUSE...
Page 117 2) Cradle the footswitch after surgical cases have been completed. 3) If condition persists, note advisory number and contact alcon technical services. See the about dialog for alcon technical services contact information." Alert Incompatible software version Footswitch version not supported...
Page 118 (Table 5-2 Continued) ADVISORIES Event Event Detail Message to User Code Type Footswitch Mechanism Alert Battery failure (during wireless operation) Footswitch failure detected Alert Pairing failed (pairing handshake over Footswitch pairing failed. Please re-cradle wireless failed) the footswitch to try again. Alert Footswitch recovered from critical error.
Page 119 (Table 5-2 Continued) ADVISORIES Event Event Detail Message to User Code Type Alert Libero error Libero communication error. Alert Camera version error The firmware installed on the camera is incorrect. Some camera functions may not operate correctly. Alert Camera communications error Camera communication error.
Page 120 (Table 5-2 Continued) ADVISORIES Event Event Detail Message to User Code Type Power Control Mechanism 1101 Alert "Mechanism time out error. Note: this alert Power control mechanism error. is generated by the host based on 1) absence of communication." 1103 Alert Mechanism software error.
Page 121 (Table 5-2 Continued) ADVISORIES Event Event Detail Message to User Code Type Malfunction Subsystem 2201 Alert "Subsystem time out error. Note: this alert Microscope not available. is generated by the host based on absence of communication." 2202 Alert Subsystem fault Microscope not available.
Page 122 (Table 5-2 Continued) ADVISORIES Event Event Detail Message to User Code Type 2354 Alert Lamp bulb or LED module failure Lamp bulb failed. Replace the bulb or LED module. 2355 Alert Lamp fan failure Lamp fan failed. 2360 Alert Enhanced libero x actuator calibration "X actuator failure detected, x positioning failure.
Page 123 (Table 5-2 Continued) ADVISORIES Event Event Detail Message to User Code Type 2385 Alert Led driver 2.048V reference voltage range Led not available. error 2386 Alert Led temperature is critically high. Led temperature is critically high. 2387 Alert Led driver board temperature is critically Led driver board temperature is critically high.
Page 124: Section Six - Accessories And Parts
This section of the operator’s manual contains references for Alcon-approved accessories and replacement parts. The lists are not comprehensive of all accessories; please contact your local Alcon representative for the latest accessories. Use of non-approved accessories is not recommended. For additional information, please contact the Alcon Sales Department.
Page 125 Table 6–1 Accessories and Parts Catalog Number Description LX3 Catalog Items 8065753073 LED Luxor™ 175 mm, LX3 8065753072 LED Q-Vue™ 175 mm, LX3 8065753071 LED Q-Vue™, 200 mm, LX3 8065753095 Stand, LX3 LED 8065752566 Footswitch, LX3 8065753082 Luxor™/Q-Vue, LED, Small Parts Kit 8065000004 Manual, Oper, Revalia (LX3 LED) Other Items...
Page 126 Catalog Number Description 8065752389 WD=175 mm Objective For Luxor™ Microscope 8065752391 WD=200 mm Objective For Luxor™ Microscope 8065752546 Medicapture Video Recording System 8065752549 Video Cable 4M, 1Mos/Ccd HD, Ul & Ce 8065752550 Video Cable 10M, 3Mos/Ccd HD, Ul & Ce 8065752551 Video Cable 15M, 1Mos/Ccd HD, Ul &...
Page 127: Video Camera Installation (External Video Package Installation Only)
Video Camera Installation (External Video Package Installation Only) 1. Remove the binoculars from the LuxOR Revalia™ (LX3 LED) microscope, by first unscrewing the locking thumbscrew and lifting the binocular upward, (Figure 6–1). Lift binocular up and off microscope Thumbscrew Figure 6–1 Removing the Binoculars 2.
Page 128 3. Place the binocular on top of the beam splitter and tighten beam splitter locking thumbscrew securely (Figure 6–3). Binocular Thumbscrew Figure 6–3 Replacing the Binoculars 4. Remove the port cover on the doctor’s preferred side of the beam splitter by unscrewing the lock ring.
Page 129 Video Recorder Video Camera Figure 6–5 Installing the Video Camera and Recorder 6. Select your configuration from Figures 6-6 through 6-9, and make the required connections to the peripheral devices. Panasonic 1MOS/CCD HD Video Camera Controller Supplied Power Supply HD Cable male/male 6’...
Page 130 Panasonic 1MOS/CCD HD Video Camera Controller Supplied Power Supply HD to DVI Cable male/male 6’ - 20’ length as needed MediCapture Video Recording Device HD to DVI Cable male/male 6’ - 20’ length as needed Monitor of choice with HD Input Figure 6–7 Panasonic 1MOS/CCD HD Camera Controller to MediCapture Video Recording Device to Monitor.
Page 131: Fine Tune The Image
Panasonic 3MOS/CCD HD Video Camera Controller Supplied Power Supply HD to DVI Cable male/male 6’ - 20’ length as needed MediCapture Video Recording Device HD to DVI Cable male/male 6’ - 20’ length as needed Monitor of choice with HD Input Figure 6–9 Panasonic 3MOS/CCD HD Camera Controller to MediCapture Video Recording Device to Monitor Fine tune the image...
Page 132: Focus The Camera
Focus the Camera 8. Set microscope eyepieces at 0 diopters or to your visual correction if spectacles are not worn. 9. Set microscope to high magnification and, looking at a fixed target, focus microscope on target. 10. Open iris control and turn fine focus control until video image is in sharp focus. Verify that microscope is still in focus.
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Page 134: Section Seven - Index
SECTION SEVEN - INDEX Accessories and Parts .......................6.1 Accessory Equipment Warnings ....................1.14 Advisories ..........................5.1 Alert ............................5.1 AMP Control ..........................2.7 Automated Wash Procedure .....................4.4 Balance the Articulating Arm ....................3.15 Balance Value Examples for LED Illumination ..............2.19 Before Every Use of the Instrument ..................1.4 CAUTION ..................1.9, 1.18, 1.19, 4.1, 4.8, 4.10 CAUTIONS ....................1.6–1.28, 1.12–1.28 Charging Footswitch Battery ....................2.10...
Page 135 Icons ............................1.25 Indication(s) For Use .......................1.2 Intended Use ..........................1.2 Introduction ..........................5.1 Labels .............................1.27 LIBERO-XY™ Connector Panel.....................2.5 Light ON/OFF and Light Intensity ..................2.42 LIMITED WARRANTY ......................x LuxOR Revalia™ (LX3 LED) Microscope with Q-VUE™ 3D Assistant Visualization ..2.7 LuxOR Revalia™ (LX3 LED) Ophthalmic Microscope ............2.6 MAG (Magnification) ......................2.28 Manual Cleaning Procedure .....................4.4 Menu / Doctor Settings ......................2.31...
Page 136 Safety Notes On Use and Installation ..................1.3 Safety performance ........................ix Screen Brightness ........................2.29 Set the Lower Limit Safety Stop ....................3.17 Setting Up the LuxOR Revalia™ (LX3 LED) Ophthalmic Microscope .........3.1 Set White Balance ........................3.12 Shutdown ..........................3.13 Specifications .........................1.22 Standby Switch ........................2.3 Sterilization Procedure ......................4.6 Surgery Screen - LED Illuminator Module................2.16 System Description ........................2.1...
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