CENTURION VISION System Operators Manual

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Operator's Manual

Manufacturer: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 USA Made in USA with Global Materials Produced By: Alcon Research, LLC. 15800 Alton Parkway Irvine, California 92618-3818 U.S.A. Telephone:

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949/753-1393 800/832-7827

CATALOG NUMBER TEXT ONLY

© 2018, 2020 Alcon Inc. Issued Date: 21 SEP 2020

EC

REP

Alcon Laboratories Belgium Lichterveld 3 2870 Puurs-Sint-Amands Belgium

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Centurion™ Vision System Operator's Manual 8065754021 MANUAL REVISION RECORD DATE

REVISION

ECN NUMBER AND DESCRIPTION

AUG 2018

K

ECN 20180857 - Initial release of Centurion™ Vision System Operator's Manual for systems with 3.02 software.

05 June 2020

L

CN100458ECN - Updated EC REP address, trademarks, logo, accessories, labeling location diagrams, specifications, product certifications, and added hybrid tip information.

Revisions not used: A-J

END USER LICENSE AGREEMENT: This product contains software licensed from Microsoft Corporation. ** Trademarks are property of their respective owners. ii

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TABLE OF CONTENTS SECTION ONE - GENERAL INFORMATION

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General Description of the Centurion™ Vision System... 1.1 Key Features of the Centurion™ Vision System... 1.2 Indication(s) For Use... 1.3 Intended Use(s) Environments... 1.3 Phaco Handpiece Note... 1.3 Trademark Note... 1.3 Abbreviation Descriptions... 1.3 Accessory Equipment... 1.3 User Information – Environmental Considerations... 1.4 Universal Precautions... 1.4 Equipment Contains Radio Transmitters... 1.7 USA – Federal Communications Commission (FCC)... 1.7 Canada – Industry of Canada (IC)... 1.8 Europe – RED Directive 2014/53/EU... 1.8 Summary of Centurion™ System Wireless Certifications... 1.9 Warnings and Cautions... 1.10 Phaco Handpiece Care... 1.12 Phaco Handpiece Tips... 1.13 Ultraflow™ II I/A Handpiece... 1.14 Recommended Vacuum Range for I/A Tips (Metal or Polymer)... 1.14 Centurion™ Vitrectomy Probe... 1.14 INTREPID™ AutoSert™ IOL Injector... 1.15 Aspiration/Vacuum Adjustments... 1.15 Presurgical Check-out Tests... 1.16 IV Pole... 1.16 Footswitch... 1.16 Occlusion Tones... 1.17 Vacuum Tone... 1.17 Cautery, Diathermy, Coagulation Definition... 1.17 Coagulation Function... 1.18 VideOverlay System... 1.19 Consumable Packs and Single-Use Accessories... 1.20 Product Service... 1.21 Limited Warranty... 1.22 SECTION TWO - DESCRIPTION

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Description of Centurion™ Vision System... 2.1 Centurion™ Vision System Console and Accessories... 2.2 Description Of Console... 2.2 Fluidics Module... 2.2 Front Display Panel and Touch Screen... 2.2 Adjustable Instrument Tray... 2.3 Front Panel Connectors... 2.3 Standby Power Switch... 2.4 Accessory Drawer... 2.4 Audio Speakers... 2.4 Locking Caster Wheels... 2.5 Handle Bar... 2.5 8065754021 L

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SECTION TWO - DESCRIPTION

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Equipotential Ground Connector... 2.5 AC Power Cord Hanger... 2.5 Primary AC Power Switch... 2.5 Footswitch Hanger / Charging Station... 2.5 Input/Output (I/O) Connector Panel... 2.5 Rotating Work Surface... 2.6 Fluidics Administration... 2.7 Power IV Pole and Hanger for Gravity Fluidics... 2.7 Bag Bay for Active Fluidics™ Technology... 2.7 Description of Footswitch... 2.8 Footpedal Control... 2.9 Toe Switch Control... 2.10 Footswitch Status LEDs... 2.13 Charging Footswitch Battery... 2.13 Pairing Footswitch with Centurion™ System... 2.14 Ship Mode... 2.14 Footswitch Floor Security... 2.15 Description of IR Remote Control... 2.16 Remote Control Keys and Buttons... 2.16 Remote Control Batteries... 2.18 Select Remote Control Channel... 2.19 Handpieces, Tips, and Infusion Sleeves... 2.20 Phaco Handpieces... 2.20 TurboSonics™ Family of Tips... 2.22 Infusion Sleeves... 2.23 Ultraflow™ II I/A Handpiece... 2.24 INTREPID™ AutoSert™ IOL Injector... 2.25 Centurion™ UltraVit™ Probe... 2.27 Fluidic Management System... 2.28 Description... 2.28 Consumable Pack Configurations... 2.29 CustomPak™ Surgical Procedure Pack Configurations... 2.29 Centurion™ Fluidic Management System Packs... 2.30 High Definition Video Overlay (optional item)... 2.31 Set Up High Definition Videoverlay (HDVO) In Wired Configuration... 2.36 Centurion™ Vision System Operator Interface... 2.38 Front Display Panel And Touch Screen... 2.38 Setup Screen and Its Functions... 2.39 1. Status Panel... 2.39 1.1 Doctor Name Button... 2.40 Manage Doctors…. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.41 1.2 Procedure Type Button... 2.43 1.3 Remote Control Button... 2.45 1.4 Front Panel Button... 2.45 1.5 Footswitch Button... 2.46 1.6 Cumulative Dissipated Energy (CDE)... 2.47 1.7 Wireless Device Pairing Indicator... 2.47 2. Setup Status Window... 2.49 Custom Button... 2.50 2.1 Custom / Doctor Settings... 2.51 Custom / Doctor Settings / General Tab... 2.51 Custom / Doctor Settings / Fluidics Tab... 2.53 iv

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SECTION TWO - DESCRIPTION

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Custom / Doctor Settings / Footswitch Tab... 2.54 Custom / Doctor Settings / Sounds Tab... 2.55 Custom / Doctor Settings / SGS Tab... 2.56 Custom / Doctor Settings / Advanced Tab... 2.56 2.2 Custom / Save... 2.57 2.3 Custom / Save As... 2.57 2.4 Custom / System Settings... 2.58 Custom / System Settings / General Tab... 2.58 Custom / System Settings / Wireless Tab... 2.60 Custom / System Settings / Pairing Tab... 2.62 Custom / System Settings / Upload Tab... 2.66 2.5 Custom / Backup/Restore... 2.68 Custom / Backup/Restore / Backup Tab... 2.68 Custom / Backup/Restore / Restore Tab... 2.68 2.6 Custom / Export... 2.69 2.7 Custom / Procedure Builder... 2.70 2.8 Custom / About... 2.73 2.9 Custom / View Events... 2.73 2.10 Custom / Shutdown System... 2.74 3. Setup Steps... 2.74 Prime FMS / Prime Bag Button... 2.74 Fill Button... 2.75 Test Handpiece Button... 2.76 PEL Button... 2.76 Surgery Button... 2.76 Surgery Screen and Its Functions... 2.77 1. Status Panel... 2.77 2. Surgery Window... 2.77 2.1 Surgery Controls... 2.79 2.2 Fluidics Controls... 2.82 2.3 Surgery Window with Phaco Steps... 2.87 2.4 Surgery Window with I/A Steps... 2.87 2.5 Surgery Window with AutoSert™ Injector Step... 2.88 2.6 Surgery Window with Coagulation Step... 2.88 2.7 Surgery Window with Anterior Vitrectomy Step... 2.89 3. Surgery Steps... 2.90 3.1 Setup Button... 2.91 3.2 Procedural Step Buttons... 2.91 3.3 Stationary Step Buttons... 2.91 Surgery Modes... 2.92 Phaco Mode of Operation... 2.92 Power/Amplitude... 2.92 Phaco Timing Configurations... 2.93 Irrigation/Aspiration Mode of Operation... 2.96 Vacuum Control... 2.97 Aspiration Control... 2.97 Using Fill Step for Irrigation/Aspiration... 2.97 AutoSert™ Mode of Operation... 2.98 Coagulation Mode of Operation... 2.101 Anterior Vitrectomy (Ant Vit) Mode of Operation... 2.103

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SECTION THREE - OPERATING INSTRUCTIONS

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Introduction... 3.1 Power Up Sequence... 3.1 Shut Down Sequence... 3.1 Initial System Setup... 3.2 Centurion™ FMS Pack Setup Procedure... 3.3 Phaco Handpiece Setup and Test... 3.5 Irrigation/Aspiration Handpiece Setup... 3.9 Intrepid™ Autosert™ IOL Injector Setup... 3.10 Centurion™ UltraVit™ Probe Setup (Using Vitrectomy Setup Dialog)... 3.13 Centurion™ Ultravit™ Probe Setup (Without Using Vitrectomy Setup Dialog)... 3.16 Coagulation Handpiece Setup... 3.17 SECTION FOUR - CARE AND MAINTENANCE

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Introduction... 4.1 Care and Cleaning... 4.4 Sterilization Instructions... 4.5 Fuse Replacement... 4.6 Packing the Centurion™ System for Transit... 4.7 Setting Up the Reconstitution Rack... 4.8 SECTION FIVE - TROUBLESHOOTING

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Introduction... 5.1 System Messages... 5.1 SECTION SIX - ACCESSORIES AND PARTS

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Introduction... 6.1 Catalog Items... 6.2 SECTION SEVEN - INDEX

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Alphabetized Listing of Topics... 7.1

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PREFACE This operator's manual is your written guide to the Centurion™ Vision System and considers all options available to the customer; therefore, when reading this manual, ignore the options which do not apply to your specific unit. Please read the entire manual carefully before operating the instrument. Recommended settings are given only as guidelines, and are not meant to restrict the surgeon; however, before trying other settings, the surgeon and support personnel should be experienced with the system and familiar with the new settings. NOTE: If an inconsistency exists between the instructions in the operator's manual and the Directions For Use (DFU) supplied with a consumable pack or accessory, follow the DFU. Equipment improvement is an on-going process and, as such, changes may be made to the equipment after this manual is printed. Pay close attention to Warnings, Precautions, Cautions, and Notes in this manual. A Warning statement is written to protect individuals from bodily harm. A Precautionary statement is action taken in advance to protect against possible danger, failure, or injury; a safeguard. A Caution statement is written to protect the instrument from damage. A Note is written to bring attention to highlighted information. If you have questions, or want additional information, please contact your local Alcon representative or the Alcon Technical Services Department at: Alcon Research, Ltd. 15800 Alton Parkway Irvine, California 92618 (949) 753-1393 FAX (949) 505-6614 CAUTION U.S. Federal Law restricts this device to sale by or on the order of a physician.

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SECTION ONE - GENERAL INFORMATION GENERAL DESCRIPTION OF THE CENTURION™ VISION SYSTEM The Centurion™ Vision System is an ophthalmic surgical instrument designed to provide for cataract lens extraction using the Centurion™ OZil™ handpiece, Centurion™ Active Sentry™ handpiece, and the Infiniti™ OZil™ handpiece. The Centurion™ Vision System is intended for use in small incision cataract lens extraction and IOL injection surgical procedures. This system allows the surgeon to emulsify and aspirate the lens in the eye, while replacing aspirated fluid and lens material with balanced salt solution. This process maintains a stable (inflated) eye chamber volume. Using system controls, the surgeon regulates the amount of energy applied to the handpiece tip, the rate of aspiration, vacuum, and the flow of BSS™ irrigating solution. The system includes a footswitch to enable the surgeon to control flow of fluidics, aspiration rate, phaco power, vitrectomy cut rate, IOL injection rate, and coagulation power.

Figure 1-1 The Centurion™ Vision System

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Key Features of the Centurion™ Vision System •

• • • • • • • • • • • • • • • • • • • • • • • •

Customized cataract lens removal options: - High performance Centurion™ Active Sentry™ handpiece with precise point of action fluidics control. - High performance Centurion™ OZil™ handpiece with ultrasonic torsional oscillations which can be used exclusively, combined, or alternated with traditional phaco. - High performance Infiniti™ OZil™ handpiece with ultrasonic torsional oscillations which can be used exclusively, combined, or alternated with traditional phaco. Advanced fluidics with quick, smooth control of aspiration and vacuum. Advanced Active Fluidics™ technology with quick, smooth control of irrigation flow, controlled via the front panel, footswitch, or remote control. Automated IV pole for traditional gravity fluidics, controlled via the front panel, footswitch, or remote control. Programmable IOP target setting. Fully programmable, multi-microprocessor control. Modularized fluidic connections with disposable Fluidic Management System (FMS). Emulation of venturi-like fluidic performance. Power assisted IOL insertion by way of lightweight, autoclavable AutoSert™ handpiece. Ability to drive a high performance Centurion™ UltraVit™ vitrectomy guillotine cutter. Bipolar coagulation capability. Several traditional modalities of ultrasonic power control including continuous, pulsed, and burst application of ultrasonic power, as well as duty cycle management. Wireless linear footswitch control of ultrasonic power in phaco steps (sophisticated control loop offers low-end control). Wireless linear footswitch control of aspiration flow rate in I/A, vit, and lens removal steps. Wireless linear footswitch control of vacuum in I/A, vit, and lens removal steps. Wireless linear footswitch control of IOL insertion. On-demand continuous irrigation. Programmable, pressurized reflux via the footswitch. Ability to set IOP, vacuum levels, and aspiration flow rates to desired levels in phaco, I/A, and vit steps. Ability to switch between surgical steps using touch screen, remote control, or footswitch. Emission of variable tones for confirmation of system operational status. Voice confirmation during surgical step or mode changes. Articulating flat screen: active matrix color LCD with touch screen. High-tech graphical user interface. Multi-channel IR remote control.

The Centurion™ Vision System, including accessories approved by Alcon, constitutes a complete surgical system and is intended exclusively for use by licensed ophthalmic surgeons and their surgical teams. These surgical teams are experienced at conducting phacoemulsification procedures in a properly maintained surgical environment (qualified personnel, availability of backup equipment) and are familiar with the operation of the equipment used as outlined in operator's manuals and directions for use (setup/checkout procedures to be completed before the surgical procedure; processing of reusable devices; maintenance; etc.). 1.2

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Patient selection for use with the Centurion™ Vision System (such as age, ophthalmic pathology, and other factors) is determined by the surgeon. The general patient age can range from newborn to geriatric, although there have been studies that have identified the mean age of patients that underwent cataract surgery was 72.32 yrs - men and 74.89 yrs - women.1 Indication(s) For Use The Centurion™ Vision System is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection. If used, the AutoSert™ IOL Injector Handpiece is intended to deliver qualified AcrySof ™ intraocular lenses into the eye following cataract removal. The AutoSert™ IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert™ IOL Injector Handpiece is indicated for use with AcrySof ™ lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof ™ lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses. Intended Use(s) Environments The Centurion™ Vision System is intended for extracapsular cataract extraction, as well as associated procedures such as anterior vitrectomy, coagulation, and intraocular lens insertion. The system is intended for use in hospitals and ambulatory surgery centers. The system is intended to be used by licensed ophthalmic surgeons and their surgical teams in an operating room. Phaco Handpiece Note Throughout the rest of this manual the Centurion™ OZil™ handpiece, Centurion™ Active Sentry™ handpiece, and the Infiniti™ OZil™ handpiece will be referred to as phaco handpieces, unless one or the other must be referred to exclusively. Trademark Note A button, mode, or step labeled OZil™ or AutoSert™ refers to a display screen control used with a phaco handpiece or INTREPID™ AutoSert™ IOL injector, respectively. Abbreviation Descriptions Many of the abbreviations used in this manual and on the Centurion™ Vision System are described in Table 1-4. Icons are identified in Figure 1-2. Accessory Equipment Accessory equipment connected to or used with this equipment must be certified according to the respective IEC Standard (e.g., IEC 60950-1 for data processing equipment, and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with clause 16 of IEC 60601-1:2005 (as amended). Anyone connecting additional equipment or otherwise causing a different system configuration than provided by Alcon is responsible for continued compliance to the requirements of clause 16 of IEC 60601-1:2005 (as amended). If in doubt, consult the Technical Services department or your local Alcon representative. 1

“Age and sex profile of patients having cataract surgery between 1986 and 2003” Philip O'Reilly, FRCSI (Ophth), U. Mahmound, FRCOphth, P. Hayes, FRCOphth, P. Tormey, FRCOphth, S. Beatty, MD. Journal of Cataract Refractive Surgery 2005; 31:2162-2166

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Follow local governing ordinances and recycling plans regarding disposal or recycling of device components and packaging. User Information – Environmental Considerations The equipment that you have purchased requires the use of natural resources for its production and operation. This equipment may also contain hazardous substances which could have potential effect on the environment and human health if disposed of improperly. In order to avoid the entry of any such substances into our environment, and to promote natural resource conservation, please install, maintain, and operate the equipment in accordance with the instructions. Information on the location of hazardous substances, resource consumption and emissions of the equipment can be found throughout this 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.

Pb

The crossed-bin symbol located on this equipment reminds you to use take-back systems, while also emphasizing the requirement to collect waste equipment separately, and not dispose of it as unsorted municipal waste. The Pb notation, if present, indicates that the labeled device contains greater than 0.004% lead. If you need more information on the collection, reuse or recycle systems available to you, please contact your local or regional waste administration, or contact your local Alcon office for more information. Universal Precautions Universal precautions shall be observed by all people who come in contact with the instrument and/or accessories to help prevent their exposure to blood-borne pathogens and/or other potentially infectious materials. In any circumstance, wherein the exact status of blood or body fluids/tissues encountered are unknown, it shall be uniformly considered potentially infectious and handled in accordance with OSHA or your own national guidelines. Electromagnetic Compatibility (EMC) Compliance It is important to install and use the equipment in accordance with the instructions in order to prevent harmful interference with other devices in the vicinity. If this equipment causes harmful interference to other devices (determined by turning equipment off and on), the user is encouraged to try to correct interference by one or more of the following measures:

1.4

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Reorient or relocate the other device(s).

•

Increase the distance between the equipment.

•

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.

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Users should be aware of known RF sources, such as radio or TV stations and hand-held or mobile two-way radios, and consider them when installing a medical device or system. Portable and mobile RF communications equipment such as cellular telephones can affect medical electrical equipment. Be aware that adding accessories or components, or modifying the medical device or system, may degrade the EMI performance. Consult with qualified personnel regarding changes to the system configuration. WARNINGS! •

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.

•

The system should not be used adjacent to, or stacked with, other equipment; and that if adjacent to or stacked use is necessary, the system should be observed to verify normal operation in the configuration in which it will be used.

•

MAGNETIC AND ELECTRICAL INTERFERENCE - Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all external devices operated in the vicinity of the device comply with the relevant EMC requirements. X-ray equipment, magnetic resonance tomography (MRT), nuclear magnetic resonance (NMR), or magnetic resonance imaging (MRI) devices are possible sources of interference as they may emit higher levels of electromagnetic radiation. See the Magnetic Resonance Unsafe icon in Figure 1-2.

The Centurion™ Vision System is designed to work in Professional Healthcare facility environment. Table 1-1

Guidance and Manufacturer's Declaration - Electromagnetic Emissions

The Centurion™ Vision System is intended for use in the electromagnetic environment specified below. The customer or the user of the Centurion™ Vision System should assure that it is used in such an environment.

Emissions Test

Compliance

Electromagnetic Environment-Guidance

RF emissions CISPR 11

Group 1

The Centurion Vision System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ Flicker emissions IEC 61000-3-3

Complies

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The emissions characteristics of Centurion™ Vision System make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it used in residential environment (for which CISPR 11 class B is normally required) Centurion™ Vision System might not offer adequate protection to radiofrequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

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Table 1-2

Guidance and Manufacturer's Declaration - Electromagnetic Immunity

The Centurion™ Vision System is intended for use in the electromagnetic environment specified below. The customer or the user of the Centurion™ Vision System should assure that it is used in such an environment.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment-Guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±8 kV contact ±15 kV air

±8 kV contact ±15 kV air

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst IEC 61000-4-4

±2 kV for power supply lines ±1 kV for input/output lines

±2 kV for power supply lines ±1 kV for input/output lines

Mains power quality should be that of a typical hospital (including ambulatory surgery center) environment. To avoid pre-mature shutdown due to fast transients avoid powering the Centurion™ Vision System on the same branch circuit with sources that can generate fast transients (inductive switching; e.g., high current motors).

Surge IEC 61000-4-5

±1 kV differential mode ±2 kV common mode

±1 kV differential mode ±2 kV common mode

Mains power quality should be that of a typical hospital (including ambulatory surgery center) environment.

Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11

0% Ut for 0.5 cycle at 8 Φ angles

0% Ut for 0.5 cycle at 8 Φ angles

0% 1 cycle 70% Ut for 25/30 cycles

0% 1 cycle 70% Ut for 25/30 cycles

0% for 250/300 cycles

0% for 250/300 cycles

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

30 A/m, 50/60 Hz

30 A/m, 50/60 Hz

Conducted RF IEC 61000-4-6

3 Vrms 150 KHz to 80 MHz 6 Vrms at ISM Frequencies

3 Vrms 150 KHz to 80 MHz 6 Vrms at ISM Frequencies

The ISM (industrial, scientific and medical) bands between 150 KHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.7 GHz

3 V/m 80 MHz to 2.7 GHz

The dwell time should be at least 1 s and should be no less than the response time of the slowest responding function plus the settling time of the IMMUNITY test system.

IEC 61000-4-3 Proximity Fields from RF wireless communication equipment

Frequency (MHz)

Level (V/m)

Frequency (MHz)

Mains power quality should be that of a typical hospital (including ambulatory surgery center) environment. If the use of the Centurion™ Vision System requires continued operation during power mains interruptions, it is recommended that the Centurion™ Vision System be powered from an uninterruptible power supply with a minimum rating of 1200VA. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical hospital (including ambulatory surgery center) environment.

Level (V/m)

385

27

385

27

450

28

450

28

710,745,780

9

710,745,780

9

810,870,930

28

810,870,930

28

1720,1845,1970

28

1720,1845,1970

28

2450

28

2450

28

5240,5500,5785

9

5240,5500,5785

9

The IMMUNITY TEST LEVELS specified in the table were calculated using the following equation: E=(6√P)/d Where P is the maximum power in W, d is the minimum separation distance in m, and E is the Immunity Test Level in V/m. The factor of 6 is a compromise for a range of antenna factors to simplify the test.

WARNING! Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Centurion™ Vision System including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

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Equipment Contains Radio Transmitters The Centurion™ Vision System is a medical device designed for Indoor Use Only, that incorporates short-range frequency radio transmitters for use solely by the Centurion™ system for communication with system components. These short-range frequency radio transmitters meet the EU and AFTA countries requirements. They are also FCC; IC; RED and Japanese Radio Law compliant. •

ZigBee Radio Modular (Communication link with Footswitch, SGS and Media Center) -

Frequency or frequency band of transmission and reception: 2.405 – 2.480 GHz

-

The Effective Radiated Power (ERP): 12.91 dBm (19.54 mW)

-

•

Wireless LAN device (Optional) -

Frequency or frequency band of transmission and reception: 2.412 – 2.484 GHz

-

The Effective Radiated Power (ERP): 17.09 dBm (51.17 mW)

-

•

Type and frequency characteristics of the modulation: OQPSK (Offset quadrature phase-shift keying)

Type and frequency characteristics of the modulation: OFDM, DSSS, CCK, DQPSK, DBPSK, 64 QAM, 16 QAM

Wireless Footswitch Charger -

Frequency or frequency band of charging transmission and reception: 50 kHz

-

Type and frequency characteristics of the modulation: FSK (Frequency Shift Keying)

-

-

Frequency or frequency band communication transmission: 115 kHz

The Effective Radiated Power (ERP): -14.89 dBm (53.18 μW)

USA – Federal Communications Commission (FCC) This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) 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 CAUTION 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.

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Canada – Industry of Canada (IC) This device complies with Industry Canada licence-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. Cet appareil est conforme aux normes d’Industrie Canada RSS exemptes de licence. Son fonctionnement est soumis aux deux conditions suivantes: (1) Cet appareil ne doit pas provoquer d’interférences nuisibles, et (2) cet appareil doit accepter toute interférence, y compris les interférences pouvant provoquer un fonctionnement indésirable de l’appareil. Transmitter Antenna: Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication. Conformément à la réglementation de l’industrie du Canada, cet émetteur de radio ne peut être utilisé qu’avec un type d’antenne approuvé pour l’émetteur par Industrie Canada et seulement avec une valeur de gain inferieur ou égale au gain maximum approuvé par Industrie Canada. Pour réduire les risques potentiels d’interférence à autrui, le type d’antenne et son gain doivent être choisis de sorte que la puissance isotrope rayonnée équivalente (p.i.r.e.) ne dépasse pas la valeur qui est nécessaire pour une communication réussi. Exposure of Humans to RF Fields: This device complies with the RF exposure limits for humans as called out in RSS-102. Cet appareil est conforme aux limites d’exposition RF pour les êtres humains comme elles le sont notifiées dans la norme RSS-102. 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.

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Summary of Centurion™ System Wireless Certifications United States Contains FCC ID: RI7XE61 Contains FCC ID: N6C-SDMAC

Canada Contains IC: 5131A-XE61 Contains IC: 4908B-SDMAC

Korea

Taiwan

MSIP-CRI-TCS-XE61-24 R-R-Alc-Centurion

CCAL18LP1810T2 CCAJ14LP2610T9 Japan

Europe

209-J00082 209-J00083 007-AE0069

Australia

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Brazil

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WARNINGS AND CAUTIONS Many of these warnings are stated elsewhere in this manual; however, for easy reference they are repeated in greater detail here. If additional information is required, please contact your local Alcon service representative, or the Technical Services Department. There are no user serviceable components inside the Centurion™ Vision System console or footswitch. Refer all service issues to your factory-trained Alcon service engineer. WARNINGS!

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To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth (ground).

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The Centurion™ Vision System battery can only be serviced by a factory-trained Alcon service engineer. Access by untrained personnel can lead to injury.

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For continued protection against risk of fire, replace only with same type and rating of fuse.

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A qualified technician must perform a visual inspection of the following components every twelve months: - Warning Labels (see Figure 1-3) - Power Cord - Fuses

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In case of a deficiency, do not use the system; call Alcon Technical Services.

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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: EN60601-1/IEC60601-1). Values must be recorded, and if they are above the limits of the applicable standards, or 50 % above initial measurement, do not use the system; call Alcon Technical Services.

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If the Centurion™ Vision System is used at the 220 V - 240 V range in the United States or Canada, it should be used on a center-tapped, 240 V single phase circuit.

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Console isolation from mains is achieved through a two pole power switch. Turn OFF power switch or unplug the power cord from wall outlet to achieve isolation from mains.

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Do not use the Centurion™ Vision System near flammable anesthetics.

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Do not exceed maximum capacity of drain bag (500 ml). Excessive pressure can result from exceeding drain bag maximum capacity and potentially result in a hazardous condition for the patient.

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Inadvertent actuation of Prime or Tune while a handpiece is in the eye can create a hazardous condition that may result in patient injury.

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Keep clear of display base when raising display from stored position to prevent skin, hair, and /or clothing from being trapped at the base.

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The maximum allowable load on the instrument tray is 20 lb. (9 kg).

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Place the instrument tray in the stored position prior to transportation to avoid a situation that could cause the system to tip.

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Console might overbalance when it is pushed and its wheels are immobilized (blocked).

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Route the footswitch cable, power cord and any other cables connected to the Centurion™ Vision System to avoid tripping. 8065754021 L

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WARNINGS! •

Appropriate use of Centurion™ Vision System parameters and accessories is important for successful procedures. Use of low vacuum limits, low flow rates, low bottle heights, high power settings, extended power usage, power usage during occlusion conditions (beeping tones), failure to sufficiently aspirate viscoelastic prior to using power, excessively tight incisions, and combinations of the above actions may result in significant temperature increases at incision site and inside the eye, and lead to severe thermal eye tissue damage.

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Good clinical practice dictates testing for adequate irrigation, aspiration flow, reflux, and operation as applicable for each handpiece prior to entering eye.

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Ensure that the tubings are not occluded during any phase of operation.

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If the handpiece test chamber is collapsed after tuning, there is a potential of low irrigation flow through the handpiece and may result in a fluidic imbalance. This, in turn, may cause a shallowing or collapsing of the anterior chamber.

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Avoid setting the patient above the FMS unless PEL is used. Operating with the patient above the FMS without PEL adjustment will result in a lower irrigation pressure than indicated on the display, and possible underventing.

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Use of BSS™ irrigating fluid bags other than those approved by Alcon for use in the Active Fluidics™ system can result in patient injury or system damage.

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Use of appropriate technique and settings is important to minimize fragments and turbulence.

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Do not remove the FMS during the surgical procedure.

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In the event of a system error release footswitch to the up position.

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Improper handling or removal of dual irrigation handpiece tip from eye may cause draining of the fluidics system.

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In the event the system will not be in use for an extended period, it is recommended to take the following precautions to preserve the backup battery life: - Leave the system connected to facility power with the main power switch on. - Power the system on each week and leave it on at least 7 hours each time.

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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.

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Avoid spilling BSS™ irrigating solution, or moisture of any kind, around the electrical handpiece connectors.

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Do not spray any liquid (i.e. cleaning solution or water) upward into the console vents.

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Do not push or pull the unit by the display, the instrument tray, or the IV pole. Wrapping around the rear and sides of the system is a handle provided for moving the instrument. The unit should be pulled and not pushed, especially over elevator and door thresholds.

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Do not plug any USB device into Centurion™ Vision System except for approved devices for Dr. Memory Backup and Restore operations as this may interfere with the system software and can result in the system not functioning as intended.

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