Contents Contents System Information User Manual Overview Terms Abbreviations and Acronyms Symbols System Overview System Description Intended Use Indications for Use Contraindications Clinical Benefits Safety Information General Warnings and Precautions General Laser Safety Precautions (Laser Model Only) Serious Incident Reporting Electromagnetic Compatibility (EMC) Compliance Wireless Certification and Compliance Information Label Locations...
Page 6
Console Specifications UNITY Foot Controller Specifications Remote Specifications Performance Specifications System Setup Initial System Setup Move the Console Position the Display Position the Tray Pair or Connect a Foot Controller Connect Inlet Pressure (VCS models only) Prepare for Laser Use (Laser Models Only) Startup Procedure Apply Power to the Console Select a Doctor Profile and Procedure...
Page 7
Irrigating Solution Bag Controls and Indicators IOP Settings Irrigation IOP Setting (Anterior Procedures Only) Infusion IOP Setting (Posterior Procedures Only) Air IOP Setting (Posterior Procedures Only) Fluidic Functions Aspiration Control Vacuum Control Incision Size Bimanual Irrigation Reflux Anterior Segment Procedures Phacoemulsification Dedicated Irrigation and Aspiration Anterior Vitrectomy...
Page 8
Foot Controller Hangers Cable Wraps Alcon Service Expected Service Life Preventive Maintenance for Users or Responsible Organizations Remote Battery Replacement Laser Maintenance (Laser Model Only) Software Updates System Messages Event Logs Troubleshooting Troubleshooting Fluidic Functions Troubleshooting Surgical Functions Troubleshooting Laser Functions...
System Information This section includes basic information about this manual and the UNITY™ Vitreoretinal Cataract System (VCS) and Cataract System (CS). This includes details important to understanding this guide and general safety information. User Manual Overview This user manual contains safety, setup, operation, and maintenance information about the UNITY™ VCS and CS.
Abbreviations and Acronyms The following abbreviations and acronyms appear in this guide or on the console. Abbreviation or Definition Acronym ABS™ Aspiration bypass system Anterior Ant Vit Anterior vitrectomy Active Sentry Amplitude-shift keying Aspiration Body floating Bluetooth Low Energy BPSK Binary phase-shift keying BSS™...
Page 13
Abbreviation or Definition Acronym Effective radiated power Electrostatic discharge Fluid-air exchange FLACS Femtosecond laser-assisted cataract surgery Fluidics management system Foot controller position in message about BSS door open Frag Fragmentation Foot controller (as in footswitch) Frequency shift keying Gauge GFSK Gaussian frequency shift keying High frequency I/A or IA...
Page 14
Abbreviation or Definition Acronym Milliseconds Milliwatts Not Applicable NOHD Nominal ocular hazard distance OFDM Orthogonal frequency-division multiplexing Patient eye level Phaco Phacoemulsification Pounds per square inch. A unit of pressure. Quadrature modulation QPSK Quadrature phase shift keying Quad Quadrant Radio frequency RFID Radio frequency identification Seconds...
Symbols Conformity and Compliance Symbols Symbol Description Medical device Authorized representative in the European Community / European Union Caution: US federal law restricts this device to sale by or on the order of a physician WEEE indicates the product should not be discarded as unsorted waste but must be sent to separate collection facilities for recovery and recycling.
Page 16
Product Information Symbols Symbol Description Date of manufacture: YYYY-MM-DD Country of manufacture: CC Manufacturer Mass Catalog number Global trade item number Serial number Revision Front Panel Indicators Symbol Description Diathermy accessory device Ultrasound accessory device Light probe Viscous fluid control Forceps Scissors Vitrectomy cutter Multi-spot laser accessory device port...
Page 17
Rear Panel Indicators Symbol Description Active laser room indicator External air or nitrogen inlet PurePoint laser foot controller Emergency stop for the laser Ethernet Power on (laser) Power off (laser) SuperSpeed USB 3D visualization system Protective filter Remote interlock Future accessory device connection 8065000402 Rev.
The operator provides inputs using the touchscreen panel, the remote control, and the foot controllers. The UNITY VCS and CS system comes in two configurations: anterior only or UNITY CS and combined or UNITY VCS. An optional, fully integrated laser module is available that can be installed in the base of the combined configuration for vitreoretinal surgery.
Indications for Use The UNITY VCS, consisting of the console and compatible devices, is indicated for use during anterior and posterior segment ophthalmic surgery. The UNITY CS, consisting of the console and compatible devices, is indicated for use during anterior segment ophthalmic surgery.
IEC 60601-1 (as amended), clause 16. Anyone connecting additional equipment or otherwise causing a different system configuration than provided by Alcon is responsible for continued compliance with IEC 60601-1 (as amended), clause 16. If in doubt, contact Alcon Technical Services or a local Alcon representative.
Page 21
(for example, EN 60601-1 or IEC 60601-1). Values must be recorded and, if they are above the limits of the applicable standards or 50% above the initial measurement, do not use the system and call Alcon Technical Services. ...
General Laser Safety Precautions (Laser Model Only) The following precautions relate to safe laser setup and use. Refer to IEC 60825-1, ANSI Z136.1, or EN 207 for more information. Appoint a laser safety officer to supervise the installation and use of the system. ...
Serious Incident Reporting Any serious incident related to the use of this medical device should be reported to Alcon Laboratories, Inc.: In USA – (800) 757-9780 By phone: In EU/International – Contact the local country office or your Alcon distributor.
Page 24
The use of accessories, transducers, and cables other than those specified, with the exception of transducers and cables sold by Alcon as replacement parts for internal components, may result in increased emissions or decreased immunity of the system. ...
Page 25
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The system is intended for use in the electromagnetic environments specified below. The customer or the user of the system should assure it is used in such an environment. Emissions Test Compliance Electromagnetic Environment – Emissions Test Compliance Guidance...
Page 26
IEC 60601 Test and Immunity Test Electromagnetic Environment – Guidance Compliance Level hospital (including ambulatory surgery centers) 0% 1 cycle environment. If the use of the system requires variations on power continued operation during power mains 70% U for 25/30 cycles supply lines interruptions, it is recommended that the system IEC 61000-4-11...
This device may not cause harmful interference, and (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. FCC Radiation Exposure Statement WARNING:...
Page 28
Europe – RED Directive 2014/53/EU This device complies with the essential requirements of the Radio Equipment Directive 2014/53/ EU. CAUTION: The radio equipment is intended to be used in all EU and AFTA countries. Outdoor use may be restricted to certain frequencies and/or may require a license for operation. Contact local Authority for procedure to follow.
Page 29
Wireless Certification Region Certification and Compliance / label location FCC ID: VMC-NGPVFS FCC ID: VMC-NGPVID (RFID in console) United States Contains FCC ID: VMCBL654 (BLE/802.15.4 in console and foot control) Contains FCC ID: SQGBL654 (BLE in remote control) Contains FCC ID: SQG-SU60SOMC (Wi-Fi/BLE in console) Australia IC: 7345A-NGPVFS...
Label Locations Note the following safety and system label locations. Refer to the system for specific information. VCS Console (Left), Foot Controller (Middle), and Remote (Right) Labels Do not push label – Warns of a potential tip or overbalance hazard if the console is pushed when the casters are locked or the wheels are immobilized.
Contact the Alcon Sales department for in-service information prior to initial use of accessories, accessory devices, or packs. Also, contact the Sales department for additional information regarding parts and approved equipment.
Basic System Example A UNITY VCS with a Large Tray Installed and a 6 button Foot Controller Paired Console – Performs general surgical functions and communicates with connected UNITY devices (see Console Features). – Manages the flow between a fluid or air source, the console, and accessory devices (see FMS Features).
Console Features The console comes in 2 different models: VCS model (8065000296) – Supports posterior segment or anterior segment surgery. This model also supports an optional laser module (laser model). CS model (8065000297) – Supports anterior segment surgery only. Console Front Panel Features VCS Console Front Panel Features ...
Page 34
Console Rear Panel Features VCS Console Rear Panel Features Bag chamber – Secures the irrigating solution bag. Power cable hooks – Stores the power cable. Connectivity panel – Provides ports to attach certain accessories. The available ports depend on the console model.
Page 35
Console Side Panel Features VCS Console Side Panel Features Console power button – Powers the console on or off. Handle – Provides an area to grip the console and move it. Tray – Holds tools for users during setup and operation. ...
Tray Features The console supports either a small or large tray. Tray Features Surgical tray – Provides a surface to place instruments. Handle – Positions the tray when gripped. Cable holders (3) – Secure cables and tubes. ...
Foot Controller Features The system includes a 6 button (8065000298), 4 button (8065000299), and laser (8065000300) foot controller. However, the system also supports Centurion™ (8065751762, wired), Constellation™ (8065750977), and PurePoint™ foot controllers. UNITY Foot Controller Features (6 button, 4 button, and Laser) ...
The remote (8065000246) controls the display interface without physical contact with the console. It can pair with 1 console at a time. To create a sterile barrier around the remote, Alcon recommends an UNITY Remote Control Aseptic Transfer sleeve (see Create a Sterile Barrier around the Remote (Optional)).
Page 39
Motion Tracking The motion method controls the display cursor by moving the remote in the air. The cursor moves relative to the motion of the remote. Motion Tracking Example To use the motion method, press and hold the Motion Cursor button.
Laser Features (Laser Models Only) Laser models include a fully integrated laser module. A protective housing covers the laser source so that no harmful laser radiation will be emitted. Do not remove any part of this protective housing. The laser system must not be used if the protective housing has been damaged or removed.
Page 41
The switch must be reset to the initial position to restore power. – Laser operation is not possible without the key. Alcon recommends limiting access to the key to authorized and knowledgeable personnel. Do not leave the key on or near the console when not in use.
Page 42
Compatible Laser Accessories WARNING: Use only laser delivery accessory devices approved by Alcon. The console is also compatible with the following PurePoint LIO accessories. PurePoint LIO (8065752987) LIO LED (8065753009) LIO battery (8065753010) LIO battery charger (8065753011) ...
FMS Features An FMS is included in a procedure pack, along with other accessory devices and components, that are necessary to perform a particular ophthalmic procedure. The console supports packs for posterior segment, anterior segment, and combined procedures. A pack typically includes the FMS with tubing sets, tray cover, and applicable accessories and small part kits.
Read all packaging and DFUs supplied with consumable packs prior to use. The subsequent sections describe accessory device types and identify compatible models. For ordering information, contact an Alcon sales representative. WARNING: ...
Page 45
Vitrectomy Probe Light Probe Infusion Cannula Entry System 0.9 mm Tip Sleeve Catalog Number 25+ UltraVit 10K 25+ std UNITY Constellation No tip Ultra 8065000366 25+ UltraVit 10K 25+ std UNITY Constellation 30° balanced Ultra 8065000367 25+ UltraVit 10K 25+ std UNITY Constellation 45°...
Page 46
To avoid potential injury, including shock hazards to the patient and user, do not use ultrasonic handpieces not compatible with the console or handpieces repaired without Alcon authorization. The user should not to touch an activated ultrasonic handpiece tip, as injuries could occur.
Page 47
Phacoemulsification Handpieces Alcon phacoemulsification handpieces integrate irrigation, aspiration, and emulsification to simultaneously maintain or inflate the anterior chamber, emulsify the lens, and aspirate the lens material from the eye. Together, with compatible tips and sleeves, they are used for ultrasonic applications. The system supports the following phacoemulsification handpieces: ...
Page 48
Alcon reusable or disposable IA handpieces. Anterior Vitrectomy Probes and Packs Alcon vitrectomy probes are vitreous cutters that provide both aspiration and cutting. They also provide an irrigating cannula for bi-manual irrigation. The system supports the following anterior vitrectomy packs: 23 GA pack (8065753167) and 25+ pack (8065753168).
Page 49
8065000334 Posterior Vitrectomy Probes Alcon posterior vitrectomy probes cut, aspirate, and dissect tissue as well as remove the lens. The system supports the following Hypervit™ (dual cut) and Ultravit™ probes. Use only compatible Alcon vitrectomy probes. The probes are available in TOTAL PLUS procedure packs, but the following catalog numbers represent the standalone probes.
Page 50
Infusion Cannula and Entry Systems After a trocar creates an incision and the entry system provides a port, an Alcon infusion cannulaa infuses liquid or gas into the posterior eye segment to maintain intraocular pressure. Infusion cannulae and entry systems are available in TOTAL PLUS procedure packs, but the following catalog numbers represent the standalone tools.
Page 51
Light Probes Alcon light probes provide intraocular illumination. The system supports the following light probes. Light Probes 23 GA 25 GA 25+™ 27 GA 27+™ Straight 8065750972 8065751441 8065751701 Short 8065751705 Sapphire wide angle...
Page 52
Pneumatic Handpieces Alcon pneumatic probes include a handle (725.03) and either forcep or scissor tips. The console supports 2 handles at a time: 1 with a forcep tip and 1 with a scissors tip. The system supports the following Grieshaber™ Advanced DSP tips.
Page 53
10-4000V Laser Probes (VCS Laser Models Only) Alcon laser probes emit laser for laser photocoagulation in either the anterior or posterior eye segments. The console (laser model only) supports illuminated TetraSpot™ laser probes, including 25 GA (8065000236) and 27 GA (8065000237). However, it also supports the following legacy laser probes.
To avoid possible patient injury or system damage, use only irrigating solution bags approved by Alcon for use in Active Fluidics. Other irrigating solution or infusion bags or containers may rupture or disrupt surgical procedures under certain conditions (for example, when the console is in a pressurized infusion or irrigation mode or with IOP control enabled).
Specifications Console Specifications Category Specification Dimensions (L x W x H) in stowed position 76 cm x 66 cm x 165 cm (30″ x 26″ x 65″) Maximum weight (CS only, includes 4 button foot controller and small tray) Packaged 171 kg (377 lb) Unpacked 135 kg (297 lb)
Performance Specifications Fluidics Performance Category Specification Irrigation IOP control set point (at sea level) 20 mmHg to 120 mmHg IOP set point response time (10% to 90% step change) IOP set point accuracy (at 0 flow) ±(5% of set point + 5 mmHg) Flow rate 0 cc/min to 60 cc/min Usable bag volume...
Page 58
Category Specification Vacuum fall time (from 0 mmHg to -650 mmHg, 10% to 600 ms 90%, flow of 0 cc/min) Reflux (proportional and continuous) Pressure range (at sea level) 0 mmHg to 120 mmHg Pressure accuracy (at sea level) ±(5% of set point + 5 mmHg) Reflux (micro) Pressure range (at sea level) 70 mmHg ±30 mmHg...
Page 59
Category Specification Viscous fluid control (VCS only) Modes Inject, extract, dual Injection pressure 0 psig to 80 psig Injection pressure accuracy ±(2% of set point + 1 psi) Extraction vacuum (with external pressure source) 0 mmHg to 650 mmHg Extraction vacuum (without external pressure source) 0 mmHg to 600 mmHg Extraction vacuum accuracy ±(2% of set point + 5 mmHg)
Page 60
This page is intentionally blank. 50 | System Information 8065000402 Rev. P2...
Messages) cannot be resolved by following directions from the message itself or the troubleshooting section in this manual (see Troubleshooting), do not proceed and contact Alcon Technical Services. Initial System Setup This section includes instructions to prepare the system for use at the beginning of a series of surgical cases (for example, at the beginning of a work day).
Position the Display Once the console is stationary and locked, position the display so it is visible to the user. Adjusting the Display from the Stored Position 1. Lift the display upright. 2. Rotate the display to face the surgeon or user. ...
Position the Tray The optional tray presents instruments and the remote in a convenient location. The tray articulation includes several joints along the arm to rotate the tray to either side of the console, raise or lower it, tilt it to either side, or swivel it around the end.
Pair or Connect a Foot Controller UNITY foot controllers automatically pair with the console when hung on the foot controller hooks. However, the console also supports wired connection to other foot controllers like the Centurion™, Constellation™, and laser models. Place Foot Controllers on the Ground If the desired foot controller is stored on the console, remove it from the hangers.
Page 65
WARNING: To avoid trip hazards, route the cables properly. Select a Foot Controller If the console has multiple foot controllers connected to it, perform the following steps to select the one to use: 1. Select the foot controller icon on the display. ...
The pressure source and regulators support a maximum flow of 100 slpm. WARNING: To avoid trip hazards, route the hose properly. Note: Some Alcon hoses include a right angle fitting. If desired, replace the quick disconnect fitting on the hose with the right angle fitting. 1.
Prepare for Laser Use (Laser Models Only) WARNING: Do not use unapproved laser delivery instruments. Potential hazards may occur when inserting, sharply bending or improperly securing the fiber optics. Not following the recommendations of the manufacturer may lead to damage to the fiber or beam delivery system and/or harm to the patient or laser operator.
After the console is set and physically stable, prepare and start the console. Apply Power to the Console Grounding reliability can only be achieved when equipment is connected to an equivalent receptacle marked hospital grade. Use only Alcon-supplied AC power cords. WARNING: ...
Page 69
To turn on the console, supply power and initiate the startup process. 1. Connect the power cable to a power supply. 2. Connect the power cable to the console rear panel. WARNING: To avoid trip hazards, route the cable properly. ...
Select a Doctor Profile and Procedure When the console powers on, select a doctor profile and procedure. Doctor profiles save preferences and frequent actions taken by users. Procedures include preset steps for common system uses. For more information about doctor profiles and procedures, see Additional Information. Initial Selection Profile and Procedure Selection To select a profile and a procedure, perform the following steps:...
Review the Setup Interface With a profile and procedure selected, the console proceeds to the setup screen. The setup screen provides instructions for connecting and preparing instruments before surgery. When accessory devices are connected to the console, select the corresponding boxes that appear on the screen and follow the instructions on the screen.
Select the Active Foot Controller If the console has multiple foot controllers connected to it, perform the following steps to select the one to use: 1. Select the foot controller icon on the display. 2. Select Change Footswitch. ...
DFU for specific information. WARNING: Notify Alcon immediately if any item in a procedure pack is received in a defective condition. Do not use any of the items if the sterile package is damaged or the seal is broken. In these cases, contact...
Create a Sterile Barrier around the Display and Tray Create a sterile barrier around the display (optional) and tray. 1. If needed, retrieve the sterile drapes from the Alcon procedure pack. 2. If intending to use the display touchscreen, cover the display with the display drape.
Set Up the FMS The console includes a receptacle for a UNITY FMS. The following instructions are basic procedures for preparing an FMS for use with the console. The specific requirements needed to set up and prepare the FMS depends on the FMS type and planned procedure. WARNING: ...
Page 76
Prime the FMS with Optional Two Step Prime (Anterior or Combined FMS Only) The console supports a 2-step prime process (similar to the Alcon Centurion), but the One Step Prime feature must be disabled (see Profile Surgical Preferences). This process primes the FMS separately from the accessory device.
Accessory Device Setup This section describes how to connect the compatible Alcon accessory devices to the console front panel (depending on console model). Refer to the DFU accompanying the accessory devices for more information. For all accessory devices, clean inspect, and sterilize all relevant parts according to the DFU and hospital...
Each ultrasonic tip is intended to be used only once per case, and then disposed of according to local governing ordinances. CAUTION: To avoid damage to the ultrasound handpiece or tip, use a compatible Alcon tip wrench. Prepare Phacoemulsification Handpieces Alcon phacoemulsification handpieces include the handheld device, disposable tubing, an ultrasonic tip, and an irrigation sleeve.
Page 79
Connect the Phaco Handpiece to the Console and FMS To connect phaco handpieces to the console, perform the following steps: Phaco Handpiece Connected to the Console 1. Connect the handpiece to the FMS aspiration and irrigation lines. 2. Connect the handpiece to either ultrasound port on the console and ensure the connector is fully inserted.
Page 80
Attach the Ultrasonic Tip to the Phaco Handpiece WARNING: The ultrasonic tips supplied in UNITY procedure packs are to be used only on an UNITY, ActiveSentry, or OZil fragmentation handpiece. Each ultrasonic tip is intended to be used only once per case, and then disposed of according to local governing ordinances.
Page 81
Attach the Irrigation Sleeve to the Tip 1. Slide the sleeve onto the tip. The sleeve should clear the tip bevel by 1.0 mm to 2.0 mm. 2. Align the infusion holes in the sleeve and tip. WARNING: To avoid potentially hazardous fluidic imbalances, do not mismatch ultrasonic tips and irrigation sleeves.
Page 82
Prime and Test for Phacoemulsification Procedures with Two Step Prime WARNING: To avoid a potential patient hazard or equipment damage, do not touch the accessory device tip with any solid object while active. However, during any ultrasonic procedure, metal particles may result from inadvertent touching of the tip with a second accessory device or ultrasonic energy causing micro abrasion of the tip.
Page 83
Test. Select Prepare IA Handpieces Alcon IA handpieces include the handheld device, disposable tubing, IA tip, and irrigation sleeve. If they are damaged or missing, replace them. If in doubt, contact Alcon Technical services. Note: IA handpieces require PEL setup. Parts of IA Handpieces (Irrigation Sleeve, Tip, and Handpiece) Connect the IA Handpiece to the FMS ...
Page 84
1. If necessary, thread the tip through the tip wrench opening. CAUTION: Use of a tool other than Alcon tip wrench may cause damage to the IA tip and handpiece. 2. Attach the tip base to the handpiece.
Page 85
4. Remove the tip wrench and retain it for future tip removal. Attach the Irrigation Sleeve to the IA TIp Attach the sleeve to the tip. Thread the sleeve so the tip extends as specified by the applicable DFU (around 1 mm to 2 mm).
Page 86
Note: Alcon recommends adding the Fill step before the first IA step to facilitate removal of air from the IA handpiece. Alcon also recommends adding the Fill step after the last IA step to clean the IA tip and handpiece.
Page 87
Prepare Anterior Vitrectomy Probes Each Alcon vitrectomy probe comes assembled. An irrigating cannula is provided in each pack to allow for bimanual irrigation. WARNING: Do not use unapproved vitrectomy probes with the system. Connect the Anterior Vitrectomy Probe and Irrigating Cannula to the Console and FMS To connect a vitrectomy probe to the console, perform the following steps.
Page 88
Do not operate vitrectomy probes unless the tip is immersed in sterile irrigation solution, in distilled water, or in surgical use. Vitrectomy cutting performance may vary at high altitudes. Contact Alcon Technical Services for additional information. 1.
Page 89
5. Verify the accessory device properly actuates and aspirates. If necessary, lower the cut rate until the actions are visible. The port should remain open in treadle position 1. WARNING: If the following behaviors are observed, replace the vitrectomy probe: ...
Setup for Posterior and Combined Procedures (VCS Models Only) When assembling accessory devices with detachable tips, ensure the tip is fully tightened to the handpiece or probe. If it is not secure, the console may generate a message or the tuning may be inadequate. However, do not tighten the tip so that it cannot be removed after use.
Page 91
Prepare Posterior Vitrectomy Probes Connect the Vitrectomy Probe to the Console and FMS for Posterior Procedures 1. Align the indicators on the probe connector and console vitrectomy port and push the probe connector into the port. 2. Connect the probe aspiration line to the FMS suction port. Prime the Posterior Vitrectomy Probe Before priming vitrectomy probes or using the vitrectomy function with the system, ensure all pneumatic tubing is connected.
Page 92
Prepare Fragmentation Handpieces Connect the Fragmentation Handpiece to the Console and FMS 1. For a posterior FMS, connect the female-to-female adapter to the FMS aspiration line and fragmentation handpiece. 2. Connect the handpiece to either ultrasound port on the console. Attach the Tip to the Fragmentation Handpiece WARNING: The ultrasonic tips supplied in UNITY procedure packs are to be used only on an UNITY or OZil...
Page 93
Prepare VFC Syringes Always use compatible Alcon VFC kits and follow all DFU instructions. WARNING: Do not use without a syringe stopper installed in the syringe barrel or when a stream of air bubbles is observed in the silicone oil. Actuation pressure will be delivered to the eye without the syringe stopper properly positioned and may cause ischemia and tissue damage.
Page 94
4. If no other connected accessory devices require priming or testing, select Surgery and adjust the injection pressure in accordance with the fluid viscosity (see Viscous Fluid Control). Prepare VFC syringes for Extraction To set up a VFC syringe for extraction, perform the following steps: ...
Page 95
Attach the Appropriate Tip to the Handpiece 1. Align pin in tip with groove in HP (indicator dot) and connect tip to HP 2. Twist counter-clockwise until dot on tip aligns with marking on HP. Verify and Calibrate Scissor Tips ...
Page 96
Incorrectly identifying the light probe can result in erroneous illumination levels and light hazard toxicity calculations Alcon recommends using only Alcon-validated light probes with the system, and is not responsible for the performance of light probes not identified by the system. 3.
Page 97
Prepare Laser Probes To set up laser probes and the laser module, perform the following steps: 1. Remove the dust cap from the connector. 2. Connect the protective filters to the console rear panel. 3. Verify laser type on touchscreen. ...
Adjust PEL Patient eye level influences IOP compensation based on the height of the patient relative to the console fluidics sensor. Horizontal bars along the side of the fluidics module on the console front panel illuminate to estimate the location of the eye. However, values below -20 cm are not highlighted. Instead, the console lights the bottom 3 pairs simultaneously to indicate the PEL value is below the lowest available panel light.
If the aiming beam is not present at the distal end of the beam delivery system, its intensity is reduced, or it looks diffused, this is a possible indication of a damaged or malfunctioning beam delivery system. If there is any doubt, contact Alcon Technical Services. Note: ...
Surgical Step Interface In surgery mode, the screen presents controls, limits, and settings available for selected surgical step. When not operating, the values displayed represent feature selections or defined limits of a feature. Layout Overview for Surgical Steps Surgery Screen Example ...
Interface Control Types The console uses several different types of graphical interfaces to solicit user feedback. These control interfaces are used to make selections or set values to various parameters. In general, the console uses the following types of controls. Buttons Buttons trigger some action after selection.
Toggles or Switches Toggles are buttons that change a setting between 2 states (often on or off). The console uses several different styles of toggles (see the following table for some examples). To use the toggles, select them to change the state to the opposite one. ...
Page 103
The foot controller activates system surgical operation based on the current surgical step parameters and provides limited hands-free control of console navigation. The treadle controls the surgical functions while the toe switches and buttons are configured to switch between steps or modes (see Button Preferences).
Prolonged exposure to the light emitted from this accessory device increases the risk of ocular damage. However, insufficient light intensity may result in inadequate visualization and adverse effects more serious than retinal photic damage or photoretinitis. Alcon recommends setting illumination levels to the minimum level necessary to perform the function.
Light Projection and Intensity Each light probe port can be set to a different level of brightness or intensity. However, Alcon recommends lowering the intensity settings of disabled probes to avoid sudden changes in light output (for instance, going from low output to high output) when switching between probes.
Page 106
Spectrally-Weighted Aphakic Irradiance Aphakic irradiance was determined using fiber optic light probes approved for use with the console. The value for spectrally-weighted aphakic irradiance (SWAI) was determined with an effective 3 mm diameter aperture at a distance of 5 mm in a plane perpendicular to the radiating light probe tip. Output Limits To avoid potentially unsafe operation of the system, the console warns users or prevents operation when certain thresholds are exceeded.
Color Mode Color Presets The Illuminator Color Mode Presets (3 Shown, Warm White Selected) The console provides preset output colors to apply to all illuminators. To select a preset, perform the following steps: 1. Select the color drop-down menu. Note: The drop-down menu displays the current selection.
Page 108
Custom Color Presets In addition to the provided color presets, the console also supports custom presets. To create or edit custom color presets, open the Advanced Color Mode dialog box. Advanced Color Mode Dialog Box with 2 Custom Presets 1. Select the Illuminators menu.
Irrigating Solution Bag Controls and Indicators The irrigating solution bag icon displays the estimated remaining irrigating solution. The icon changes color when the estimated volume nears empty. Irrigation Solution Bag Icon States: Full (Left) and Low (Right) To replace the irrigating solution bag during surgery, perform the following steps: ...
IOP settings compensate for potential drops in pressure due to fluid or material naturally traveling through tubes or connectors. However, Alcon recommends the surgeon continuously monitor IOP throughout the procedure. For example, common informal practices may include the following tactics: ...
To set a default setting for new procedures, see (Fluidics tab). Irrigation Pressure To set the pressure based on Alcon preset values, perform the following steps: 1. Select the current pressure value. 2. Select a pressure value button from the Preset panel.
Power toggle in the Air panel. If infusion pressure is active, enabling air disables infusion pressure. Air Pressure To set the pressure based on Alcon preset values, perform the following steps: 1. Select the current pressure value. 2.
Fluidic Functions Fluidic functions include various console functions related to the flow of fluid. The available functions depend on the selected procedure and active step. WARNING: Test for adequate irrigation and aspiration flow, reflux, and operation of each accessory device prior to entering the eye.
Incision Size The Incision Size setting helps the console compensate for potential pressure losses along the irrigation path depending on the intended length of the cut made during phacoemulsification. See the following table for recommended incision sizes for certain tip and irrigation sleeve combinations. WARNING: To avoid severe thermal eye tissue damage during lens removal, do not use a smaller incision than recommended.
Bimanual Irrigation Bimanual irrigation replaces the incision size control on the bottom right sidebar with bimanual steps. Like the incision size setting, it helps the console compensate for potential pressure losses along the irrigation path. To access bimanual irrigation, ensure a bimanual step is included in the procedure and select the step. WARNING: When using a bimanual procedure, ensure the irrigation handpiece and settings have sufficient flow characteristics.
Anterior Segment Procedures The console includes surgical steps for anterior vitrectomy, phacoemulsification, irrigation and aspiration, and other anterior segment procedures. Only use settings appropriate for the intended techniques used to achieve the desired surgical effect. Also, consider individual technique and experience level. WARNING: ...
Page 117
Phacoemulsification Settings (PrePhaco Step Example) Occlusion and Vacuum Tones The console emits different tones or sounds to indicate an occlusion or vacuum activity during operation. To control the volume or preview the sounds, see Audio Indicator Preferences. Note: Occlusion tones can be turned off, but the vacuum tone cannot be turned off. ...
Page 118
Phacoemulsification Step Controls The following controls are for surgical functions. However, the phacoemulsification steps also include fluidic controls such as aspiration flow, incision size, reflux, and vacuum (see Fluidic Functions). WARNING: To avoid the risk of thermal eye tissue damage, ensure the appropriate profile (see User Preferences) and system settings (see...
Page 119
Timing Patterns The console provides 3 different patterns for how and when the handpiece delivers power or energy to the eye while the treadle is in range 3. To set the timing pattern, select one of the following options: Note: Both burst and pulse cycles perform torsional movement before longitudinal movement. ...
Page 120
Intelligent Phaco The Intelligent Phaco feature temporarily delivers pulses of longitudinal power in proportion to torsional power for a defined pulse duration once a vacuum threshold has been surpassed. Once the vacuum drops below the threshold the longitudinal pulses cease. The feature settings apply to all phacoemulsification steps, but can be enabled or disabled for individual steps.
Page 121
Thermal Sentry The thermal Sentry feature helps to decrease wound heating effects by temporarily decreasing ultrasound power level by monitoring power level and flow conditions. The sensitivity of this feature is adjustable to tailor the feature to individual technique and conditions. To activate and set this feature, perform the following steps: ...
Page 122
Phacoemulsification Operation All phacoemulsification steps use the same foot controller treadle behavior. Press the treadle to activate the following functions in the specified ranges. WARNING: To avoid a risk of patient injury, do not inadvertently activate prime or tune accessory devices while the device is in the eye.
Dedicated Irrigation and Aspiration For dedicated irrigation and aspiration, the console provides different steps for irrigation and simultaneous peristaltic aspiration for use with independent I/A handpieces. However, half of the steps are bimanual versions of other steps. See Procedure Customization for more details on including IA steps in procedures.
Anterior Vitrectomy For anterior vitrectomy, the console provides different steps to facilitate vitreous removal (see Procedure Customization). Each step includes a control to set the cut rate of the vitrectomy probe as well as aspiration flow, bimanual irrigation, reflux, and vacuum controls. WARNING: To avoid potential performance degradation or hazard, do not operate vitreous probes in air.
When it is deactivated, fluidic functions behave as normal. Image Guidance For image guidance, the console provides different steps to align with the Alcon Verion Image Guided System (see Procedure Customization).
Posterior Segment Procedures (VCS Models Only) The console includes surgical steps for posterior vitrectomy, fragmentation, laser photocoagulation, and control of other accessory devices (such as forceps and scissors). Only use settings appropriate for the intended techniques used to achieve the desired surgical effect. Also, consider individual technique and experience level.
Fluidics Controls The fluidics controls behave the same way as with other procedures (see Fluidic Functions). However, aspiration and vacuum must be enabled. To enable or disable them, select the toggle between the Vacuum Aspiration Flow panels. Posterior Vitrectomy Operation Cut rate must be activated manually.
Fragmentation For ultrasonic fragmentation, the console provides a dedicated step to fragment and aspirate tissue. The step provides infusion through the infusion cannula, aspiration, longitudinal power, and torsional amplitude control. Together, with a fragmentation handpiece, longitudinal power and torsional amplitude alternate on and off.
Page 129
Timing Patterns The console provides 3 different patterns for how and when the handpiece delivers power or energy to the eye while the treadle is in range 2. To set the timing pattern, select the mode name and select one of the following options: Note: Both burst and pulse cycles perform torsional movement before longitudinal movement.
Forceps The console provides a dedicated step for grasping material with a pneumatically powered forceps tip. The step includes grasping pressure. Forceps Step Example Forceps Step Controls The Forceps step provides a single control over forceps pressure. Select Forceps to open the control dialog box and adjust the start and end values accordingly.
Scissors The console provides a dedicated step for cutting with a pneumatically powered scissor tip. The step includes cut behavior and rate, and forcep pressure control (for bimanual forceps). Scissors Step Scissors Step Controls The Scissors step includes a single surgical control (cut rate or cut pressure), depending on the selected mode.
Viscous Fluid Control For VFC, the console provides a dedicated step to control pressure for fluid injection (for example, silicone oil) or vacuum extraction. The vacuum also provides a means of extruding fluid through the VFC syringe. VFC Step Example VFC Step Controls The VFC step provides different controls depending on the selected mode: Inject or Extract.
Laser Photocoagulation For laser photocoagulation, the console provides a dedicated step to control the behavior and limits of a laser and an aspirating accessory device. The step includes controls for laser selection, number of spots, power for each spot, duration, interval, and aiming beam intensity. WARNING: ...
Page 134
Spots With multispot laser probes, the console provides controls to generate multiple spots at once at different power ratings. Spots – Sets the number of spots (1, 2, or 4) emitted from the laser. The 4 spot option emits the spots in a square pattern.
Press the treadle to fire the laser according to the settings. Note: Depending on the thermal load of the console, the laser may shut down prior to the treadle being released. Alcon recommends using exposure times less than 2 seconds in Continuous mode. Diathermy For diathermy, the console provides a dedicated step for either anterior or posterior segment procedures.
Page 136
To ensure safe operation of the diathermy function, note the following general precautions: Only approved cables and accessories must be used (see Alcon representative). Diathermy performance can be guaranteed only when using Alcon components or Alcon-endorsed components. Interference produced by the operation of high-frequency surgical equipment may adversely influence the operation of other electronic equipment.
Page 137
Diathermy Step Control The step provides control over diathermy power through a percentage of approximately 1.5 MHz of bipolar coagulation. Select the toggle in the treadle diagram to set either fixed or linear behavior. To adjust either the start value or the end value, select to increase the value or to decrease the value.
Page 138
This page is intentionally blank. 128 | Operation 8065000402 Rev. P2...
Service and Maintenance This section contains basic preventive maintenance information and troubleshooting ideas. There are no user serviceable components inside the console or foot controller. See Alcon Service for service information. WARNING: For all people in contact with the console and accessories, practice universal precautions to help prevent exposure to blood-borne pathogens and other potentially infectious materials.
Cleaning Wherever possible, use non-flammable agents for cleaning and disinfection. Alcon recommends the following cleaning methods and tools for the console, foot controller, and remote: Compatible Incompatible Ethyl alcohol: 70% maximum concentration Ultraviolet Radiation (UV) Isopropyl alcohol: 70% maximum ...
Clean the bottom of the foot controller and under the treadle with water or water with mild soap. Storage and Transportation If the system will not be used for an extended period, Alcon recommends the following practices to preserve the backup battery life: ...
Foot Controller Hangers CAUTION: To minimize battery degradation during long-term storage, keep UNITY foot controllers at room temperature with low humidity. 3 Stored Foot Controllers Cable Wraps Wrap the power cord around the hooks as shown above. The label between the hooks should be visible. 132 | Service and Maintenance 8065000402 Rev.
Alcon Service For product service, contact Alcon Technical Services or an authorized local service representative. For optimal performance, schedule preventive maintenance for the system and relevant accessories at least once a year. However, systems may require additional service depending on use or other circumstances.
Alcon personnel or an approved service center in accordance with published preventive maintenance schedules. For these products, the expected service life is defined by the end of service life: a minimum of 7 years after the last date of manufacture.
WARNING: If a deficiency persists, do not use the system and call Alcon Technical Services. In addition to the Alcon service recommendations (see Alcon Service), Alcon also recommends a qualified technician perform a safety inspection at least twice a year to help ensure system performance.
Laser Power Verification Contact Alcon Technical Services before conducting calibration verification. WARNING: Laser light emitted from the fiber and laser head is powerful enough to cause serious eye or skin damage.
If any of the calculated energy results are not within the specified limits, the terminal efficiencies will need to be adjusted. Contact Alcon Technical Services. Setting the Calibration Factor (Terminal Efficiencies) If unable to successfully complete the energy matrix table, use the following procedure to adjust the calibration factor, and retest.
The console may display messages when a process is interrupted or cannot be completed. When a system message is encountered, follow the provided instructions. If the instructions do not resolve the issue, do not proceed and contact Alcon Technical Services with the message identification number. WARNING: If the console displays a system error during operation, release the treadle to the up position.
Troubleshooting If the system exhibits any of the following symptoms, attempt the corresponding troubleshooting practices. However, if the mentioned troubleshooting does not resolve the issue, note the message number and contact Alcon Technical Services (see Alcon Service). WARNING: If the console displays a system error during operation, release the treadle to the up position.
Troubleshooting Fluidic Functions Symptom Troubleshooting 1. Remove kinks or occlusions from the irrigation line. 2. Inspect the instrument and tip for damage. Insufficient irrigation 3. Ensure the irrigation sleeve hole aligns with the tip flare. 4. Replace the FMS cassette.
Backup and Restore Data The console stores profile settings and system logs locally, but this data can be uploaded to an external storage device. From the storage device, the data can be used to transfer settings to another console or recover lost settings on the same console.
Additional Information Accessory Setup The console also supports additional Alcon devices through wired or wireless connectivity (for example, the video overlay, 3D visualization system, or image guided system). To connect these devices, enable the feature on the console and refer the accessory DFU.
Connect a Video Overlay Device The video overlay combines data from the console with video output from a microscope to display elsewhere. The console connects to the video overlay over wireless communication. To connect to a video overlay, perform the following steps: ...
8. Select Save. Pair a Remote The console supports 1 remote at a time. To pair a remote to the console, initiate the pairing feature to have the console and remote search for each other: 1. Select Menu > System Settings > Connections.
Profile Management Profile List – Displays the list of available doctor profiles on the console. Add Profile button – Adds a new profile based on default values. Rename Profile button – Edits the name of the selected profile. ...
Page 157
Create New Profiles with Default Settings 1. Select under Doctors: 2. Enter a profile name. 3. Select OK. Duplicate Profiles 1. Select a profile to copy. 2. Copy Select the icon. 3. Enter a new profile name. ...
User Preferences User preferences are set through the profile doctor settings. The settings include display brightness, foot controller behavior, laser preferences (laser model only), and audio volume. To change these settings, select Manage Doctors and Preferences > Doctor Settings. When all changes are made, the current profile >...
Page 159
Verify PEL toggle – Determines whether the console automatically displays the Verify PEL dialog box after priming and testing. Default PEL slider – Starts the PEL offset at the specified value. Fluidics tab The Fluidics tab in the Surgical category includes default settings for various fluidics behavior. The Fluidics tab includes the following controls ...
Page 160
Reflux tab The Reflux tab in the Surgical category allows the user to change certain preferences related to the reflux during surgery. The Reflux tab includes the following controls: Default Anterior Reflux Mode drop-down menu – Determines which reflux mode is default for anterior steps.
Page 161
Profile Foot Controller Preferences The foot controller preferences include options to define foot controller behavior and treadle ranges for different surgery types. To change the settings, select the applicable tab. General Preferences The General tab defines treadle detents and heel click numbers. The General tab includes the following controls: ...
Page 162
Anterior Range Preferences The Anterior Range tab determines how far users have to push the treadle to enter ranges 2 and 3 during anterior procedures. The ranges are represented as a percentage of the total range of motion of the treadle. For example, 0% is the treadle at rest and 100% is the treadle fully depressed.
Page 163
Posterior Range Preferences The Posterior Range tab determines how far users have to push the treadle to enter certain ranges during posterior procedures. The ranges are represented as a percentage of the total range of motion of the treadle. For example, 0% is the treadle at rest and 100% is the treadle fully depressed. The Posterior Ranges tab in the Footswitch category includes the following controls: ...
Page 164
Button Preferences The Buttons tab determines the actions the foot controllers or buttons take when activated. Actions are assigned to the foot controller switches according to procedure step. The Buttons tab in the Footswitch category includes the following controls: Preferred Mapping toggle –...
Page 165
Laser Preferences The Laser preferences determine laser foot controller settings and behavior. To make changes, select the appropriate tab. General Laser Preferences The General tab sets laser foot controller timing settings and treadle ranges. The General tab includes the following controls: ...
Page 166
Laser Foot Controller Button Preferences The Buttons tab determines the actions taken when the foot controller buttons are pressed. The Buttons tab includes the Button drop-down menus which set the side button actions. Remote Configuration The Remote option configures the remote backlighting and programmable buttons. The Remote option includes the following controls: ...
Page 167
NGENUITY Foot Controller Mapping The Ngenuity settings assign an action from a connected 3D visualization system actions to the foot controller buttons. To enable button assignment in this dialog box, navigate to Footswitch > Buttons assign NGenuity Toggle to a button. Audio Indicator Preferences The Sounds tab sets the volume level for tones and voice confirmations.
To adjust the volume for individual audio indicators, perform the following steps: 1. Individual Sound. Select 2. Select a trigger. 3. Select On/Off. 4. Either drag a slider handle or press to increase or – to decrease the volume. To test the volume, perform the following steps: ...
Page 169
Create New Procedures from Default Procedures 1. Select under Procedures: 2. In the drop-down menu, select how the console audibly announces the procedure. 3. To enter a different name, turn on the toggle under Enter new name. Note: Entering a new name changes the audio announcement to Custom.
Procedure Customization To customize or create unique sequences of surgical steps, use the Procedure Builder feature. It is available only from the Setup screen. To access the feature, perform the following steps: 1. Select the current profile or procedures. ...
Page 171
Copy or Repeat Steps Procedure Builder provides 2 ways to copy or repeat steps within a procedure: add the step again or copy the step. To add the step again, see Add Steps to the Procedure. However, the following steps describe how to copy steps already in the procedure.
Save Current Settings The console does not automatically save changes made to surgery step controls or parameters. If changes are made and they are intended to be retained for future use, save the settings before changing them again or shutting down the console. The console adds an asterisk to the end of the profile name if it has unsaved changes.
System Settings System settings apply to the entire console. They are not specific to the current profile or procedure. To Save apply changes to the system settings, select when finished with all settings. General System Settings The General System Settings tab adjusts the way things are displayed. To make changes, adjust the following controls.
Wireless Communication The Connections tab defines how the console communicates wirelessly. To enable various wireless communication methods or sync foot controllers or remote, change the following controls. Connections Dialog Box Footswitch Network toggle – Allows the console to communicate with UNITY foot controllers. ...
Device System Settings The Devices tab establishes connections with other accessories. Devices Dialog Box Ngenuity toggle – Allows an Alcon 3D visualization system to connect to the console with a wired connection (see Connect a Visualization System). Unity Video Overlay toggle –...
Page 176
For firewall packet filter rules, Alcon recommends implementing a deny by default policy (deny any/any). This policy denies all traffic unless explicitly allowed. It can extend for both ingress (inbound) or egress (outbound) traffic. In addition, review and monitor all firewall logs.
Page 177
Note: The WEEE symbol indicates waste electric and electronic equipment require separate collection. Contact Alcon Technical Services to service the batteries in the console and 6 button and 4 button foot controllers. To remove the batteries from the remote, see Remote Battery Replacement.
Need help?
Do you have a question about the UNITY VCS and is the answer not in the manual?
Questions and answers