Operator's Manual Manufacturer: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 U.S.A. EC REP Alcon Laboratories (UK) Ltd. Frimley Business Park Frimley, Camberley Surrey, GU16 7SR, United Kingdom Produced By: Alcon Research, Ltd. 15800 Alton Parkway Irvine, California 92618-3818 U.S.A.
Centurion® Vision System Operator's Manual 8065751772 MANUAL REVISION RECORD DATE REVISION ECN NUMBER AND DESCRIPTION March 2011 P2 2011XXXX - Preliminary release of Centurion® Vision System Operator's Manual with catalog number 8065751772, and 905-2150001 text (applies to Centurion® Vision System consoles with software version X.00). June, 2012 P3 2012XXXX - On page 1.23 changed Maximum Input Current in Table 1-3 from 6A to 10A. On page 1.25 changed amperage on label from 12A to 10A.
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.
GENERAL INFORMATION 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 intra-ocular lens injection. The AutoSert® IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal.
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.
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 (see Table 1-3 for recommended separation distances). Be aware that adding accessories or components, or modifying the medical device or system, may degrade the EMI performance.
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.
Table 1-3 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Centurion® Vision System - The Centurion® Vision System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Equipment Contains Radio Transmitters • ZigBee Radio Modular (Communication link with Footswitch, HUD and Media Center) - Frequency or frequency band of transmission: 2.405 – 2.480 GHz - Type and frequency characteristics of the modulation: OQPSK (Offset quadrature phase-shift keying) - The Effective Radiated Power (ERP): 12.91 dBm (19.54 mW) • Wireless LAN device (Optional) - Frequency or frequency band of transmission: 2.412 – 2.484 GHz and 5.180 - 5.
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.
Europe – R&TTE Directive 99/5/EC This device complies with the requirements of the Council Directive 99/5/EC (R&TTE). 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. NOTE: Combinations of power levels and antennas resulting in a radiated power of above 100 mW equivalent isotropic radiated power (e.i.r.
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! Appropriate use of Centurion® Vision System parameters and accessories is important for successful procedures.
Handpiece Care Phaco handpieces are surgical instruments and must be handled with care. The handpiece tip should not touch any solid object while in operation. Immediately following surgery the handpiece must be thoroughly cleaned. Be sure handpiece connector is completely dry before connecting it to console. For cleaning and sterilization procedures, see the Directions for Use (DFU) supplied with the handpiece.
CAUTIONS Never ultrasonically clean the phaco handpiece; irreparable damage may result. Prior to sterilization, the phaco handpiece should always have the connector end cap secured and placed in the sterilization tray. This will prevent damage to the connectors and handpieces during handling, and especially during autoclaving. The phaco handpiece and INTREPID® AutoSert® IOL Injector must be at room temperature just before use.
Ultraflow® II (I/A) Handpiece Prior to each procedure inspect the two O-rings where the tip screws onto the Ultraflow® II I/A handpiece. If damaged or missing, replace the o-rings. If in doubt, contact Alcon's Technical Services Department. WARNINGS! Use of non-Alcon surgical reusable or disposable I/A handpieces that do not meet Alcon surgical specifications, or use of an Alcon handpiece not specified for use with the Centurion® Vision System, may result in a fluidic imbalance.
INTREPID® AutoSert® IOL Injector • • • • • • CAUTIONS Do not ultrasonically clean the AutoSert® IOL Injector connector. Ultrasonic cleaning will cause irreparable damage. Use care when handling AutoSert® IOL Injector, particularly when cleaning. Always clean handpiece over a surface cushioned with a pad or rubber mat. Be sure handpiece cable connector is dry before connecting it to the console.
Presurgical Check-out Tests Presurgical check-out tests must be performed as outlined in the Operating Instructions section. If an Event message is displayed on the front panel, refer to the Troubleshooting section of this manual. If the problem persists, DO NOT PROCEED. WARNINGS! When filling handpiece test chamber, if stream of fluid is weak or absent, good fluidics response will be jeopardized.
Occlusion Tones Two different occlusion tones (intermittent beeping tones during occlusion) indicate that the vacuum is near or at its preset limit, and aspiration flow is reduced or stopped to avoid exceeding the limit. The first type, the I/A occlusion tone, sounds when occlusion occurs during aspiration only (in the absence of ultrasonic power). The I/A occlusion tone is a lower, intermittent single beep.
Coagulation Function Listed below are general precautions to be followed when using the Coagulation function: • To ensure safe operation of the coagulation function, only approved cables and accessories must be used (See your Alcon representative). Coagulation performance can be guaranteed only when using Alcon components or Alconendorsed components. • To reduce the risk of accidental burns, caution should always be taken when operating high-frequency surgical equipment.
VideOverlay System WARNINGS! Do not remove VideOverlay cover; there are no user-serviceable parts inside. Refer servicing to qualified service personnel. Do not simultaneously touch the VideOverlay enclosure and the patient. CAUTIONS • Do not use multiple portable socket outlets with this system. • Use only the Alcon-supplied serial cable to connect the Centurion® Vision System to the VideOverlay System. 1.
Consumable Packs Consumable items used with the Centurion® Vision System during surgery are designed to be used once and then discarded, unless labeled otherwise. All Centurion® packs contain Directions for Use (DFU). It is important to read and understand the DFU’s prior to use. In all cases, the instrument setup instructions contained in the manual should be thoroughly understood prior to using any of the pack configurations.
PRODUCT SERVICE For product service, please contact Alcon’s Technical Services Department at the number provided below. Operators experiencing problems with the system should refer to the Operating Instructions and Troubleshooting sections of this manual. A problem which persists should be referred to the Alcon Technical Services Department or your local authorized service representative.
LIMITED WARRANTY Alcon will repair or replace at its option, any system or accompanying accessories found to be defective in material and/or workmanship for a period of one (1) year from the date of initial installation. This warranty applies to the original purchaser of the system, when said system is properly installed, maintained, and operated in accordance with published instructions.
Type BF equipment, providing both the attributes of basic insulation and "floated" isolation.
® DANGER: ® RISK OF EXPLOSION IF USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS. DANGER: RISQUE D’EXPLOSION. NE PAS EMPLOYER EN PRESENCE D’ANESTHESIQUES INFLAMMABLES. CAUTION: GROUNDING RELIABILITY CAN ONLY BE ACHIEVED WHEN EQUIPMENT IS CONNECTED TO AN EQUIVALENT RECEPTACLE MARKED HOSPITAL GRADE. CAUTION: 100-120V 50/60 Hz 10A 220-240V 50/60 Hz 6A RISK OF BURNS AND FIRE - DO NOT USE NEAR CONDUCTIVE MATERIALS. RENEW ELECTRODE CABLES UPON EVIDENCE OF DETERIORATION.
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