Alcon centurion manual

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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:.

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 aspiratethelensintheeye,whilereplacingaspiratedfluidandlensmaterialwithbalancedsaltsolution. Thisprocessmaintainsastable inflated eyechambervolume. Usingsystemcontrols, the surgeon regulates the amount of power applied to the handpiece tip, the rate ofaspiration,vacuum,and theflowofBSS irrigating solution.

The system includes a footswitch to enable the surgeon to controlflowoffluidics, aspirationrate, phaco power, vitrectomy cut rate, IOL injection rate, anterior capsulotomy, and coagulation power.

AdvancedActive Fluidics technologywithquick,smoothcontrolofirrigationflow,. Wirelesslinearfootswitchcontrolofultrasonicpowerinphacosteps sophisticated. Ability to switch between surgical steps using touch screen, remote control, or footswitch. 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 theirsurgicalteams.

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 fromnewborntogeriatric,althoughtherehavebeenstudiesthathaveidentifiedthemeanageof patients that underwent cataract surgery was Intended Use Environments The Centurion Vision System is intended for use in hospitals and ambulatory surgery centers. OZil handpiece will be referred to as phaco handpieces, unless one or the other must be referred to exclusively.

Abbreviation Descriptions Many of the abbreviations used in this manual and on the Centurion Vision System are. Furthermore,allconfigurationsshallcomplywithclause16of IEC as amended. Anyone connecting additional equipment or otherwise. Beatty, MD. Journal of Cataract Refractive Surgery ; If in doubt, consult the Technical Services department or your local Alcon representative. 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. 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 reuseorrecyclemanyofthematerialsinyourend-of-lifeequipmentinabeneficialway. PleasecontactyourlocalAlconofficeforassistanceintake-backoptionsthroughAlconor other providers. 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. 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 Alconofficeformoreinformation. Universal Precautions Universal precautions shall be observed by all people who come in contact with the.

EMC Statements It is important to install and use the equipment in accordance with the instructions in. 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:. Reorientorrelocatetheotherdevice s.

Table 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. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The Centurion Vision System is suitable for use in all establishments other than domestic and those directly connected to a low voltage power supply network that supplies buildings used for domestic purposes.

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 for recommended separation distances.

Be aware that adding accessories or components, or modifying the medical device or system,maydegradetheEMIperformance. 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.

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 Table Guidance and Manufacturer's Declaration - Electromagnetic Immunity - The Centurion Vision System is intended for use in the electromagnetic environment specified below. Note: UT is the a. Note 2: These guidelines may not apply in all situations.

Electromagnetic propagation is affected by absorption and reflection from. FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To access the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the equipment or system is used exceeds the applicable RF compliance level above, the equipment or system should be observed to verify normal operation.

If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Centurion Vision System. Voltage dips, short interruptions, and voltage variations on power supply input linesIEC Floors should be wood, concrete, or ceramic tile.

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.

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 VA. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical hospital including ambulatory surgery center environment.

Portable and mobile RF communications equipment should be used no closer to any part of the Centurion Vision System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency to the transmitter.

Field strength from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. The customer or the user of the Centurion Vision System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Centurion Vision System as recommended below, according to the maximum output power of the communications equipment.

For transmitters rates at a maximum output power not listed above, the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer. Note 2 - These guidelines may not apply in all situations.

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.

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. CAUTIONTo 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 units antenna and the body of the user and any nearby persons at all times, and units antenna must not be co-located or operating in conjunction with any other antenna or transmitter.

Son fonctionnement est soumis aux deux conditions suivantes: 1 Cet appareil ne doit pas provoquer dinterfrences nuisibles, et 2 cet appareil doit accepter toute interfrence, y compris les interfrences pouvant provoquer un fonctionnement indsirable de lappareil. Transmitter Antenna: Under Industry Canada regulations, this radio transmitter may only operate using an. 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.

Conformment la rglementation de lindustrie du Canada, cet metteur de radio ne peut tre utilis quavec un type dantenne approuv pour lmetteur par Industrie Canada et seulement avec une valeur de gain inferieur ou gale au gain maximum approuv par Industrie Canada.

Pour rduire les risques potentiels dinterfrence autrui, le type dantenne et son gain doivent tre choisis de sorte que la puissance isotrope rayonne quivalente p. Cet appareil est conforme aux limites dexposition RF pour les tres humains comme elles le sont notifies dans la norme RSS Table Information on the Location of Hazardous Substances in the Centurion Vision System - The Centurion Vision System contains hazardous substances which could have potential effect on the environment and human health if disposed of improperly.

Contact local Authority for procedure to follow. 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. To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth ground. The Centurion Vision System battery can only be serviced by a factory-trained Alcon service engineer. Access by untrained personnel can lead to injury. A qualified technician must perform a visual inspection of the following components every twelve months: Warning Labels see Figure Power Cord FusesIn case of a deficiency, do not use the system; call Alcon Technical Services.

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

Inadvertent actuation of Prime or Tune while a handpiece is in the eye can create a hazardous condition that may result in patient injury. Place the instrument tray in the stored position prior to transportation to avoid a situation that could cause the system to tip. Route the footswitch cable, power cord and any other cables connected to the Centurion Vision System to avoid tripping.

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.

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

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. 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. Improper handling or removal of dual irrigation handpiece tip from eye may cause draining of the fluidics system. 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. Avoid spilling BSS irrigating solution, or moisture of any kind, around the electrical handpiece connectors. 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.

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.

If in the medical opinion of the physician a patient with a prion related disease undergoes a high risk procedure, the instrument should be destroyed or be processed according to local requirements. 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. Allow the handpiece to air cool for at least 15 minutes after autoclaving; never immerse the handpiece in liquid when hot.

Do not operate the phaco handpiece unless the tip is immersed in BSS sterile irrigating solution or distilled water or is in surgical use. Irreparable damage to the handpiece and tip can result if run dry.

Ensure that test chamber is filled with BSS sterile irrigating solution before tuning the phaco handpiece. Tuning a handpiece dry may result in premature tip failure and breakage.

Be sure handpiece is completely dry before connecting it to console. Damage to handpiece and console may result if plugged in when wet. Ensure that handpiece tip is fully tightened to the handpiece.

Ensure that the tip is not too tight so that it can be removed after use. During any ultrasonic procedure, metal particles may result from inadvertent touching of the ultrasonic tip with a second instrument.

Another potential source of metal particles resulting from any ultrasonic handpiece may be the result of ultrasonic energy causing micro abrasion of the ultrasonic tip. If damaged or missing, replace the o-rings. If in doubt, contact Alcon's Technical Services Department. Exceeding the recommended level of mmHg hPa with a 0. Only 0. Vitrectomy cutting performance may vary at high altitudes.

Consult Alcon Technical Service for additional information. Do not test or operate vitrectomy probe unless tip of probe is immersed in BSS sterile irrigating solution or distilled water or is in surgical use. Irreparable damage to the probe and tip can result if run dry. Connect pneumatic tubing connectors from vitrectomy probe to console prior to initiating prime of probe. Initiating prime of the vitrectomy probe, or running the vitrectomy system, with one or both pneumatic connectors disconnected may cause the flow of non-sterile air over the sterile field for a brief moment.

After filling and testing, and before surgical use, verify that the probe is properly actuating and aspirating. This may require lowering cut rate to achieve good visualization. The port should always remain in open position in footpedal position 1. If cutting port is partially closed while in position 1, replace the probe. 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.

Do not spray any liquid i. 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. Memory Backup and Restore operations as this may interfere with the system software and can result in the system not functioning as intended.

Grounding reliability can only be achieved when equipment is connected to an equivalent receptacle marked hospital grade. If in the medical opinion of the physician a patient with a prion related disease undergoes a high risk procedure, the instrument should be destroyed or be processed according to local requirements.

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. Allow the handpiece to air cool for at least 15 minutes after autoclaving; never immerse the handpiece in liquid when hot. Irreparable damage to the handpiece and tip can result if run dry. Tuning a handpiece dry may result in premature tip failure and breakage.

Be sure handpiece is completely dry before connecting it to console. Damage to handpiece and console may result if plugged in when wet. Phaco Handpiece Tips Ensure that handpiece tip is fully tightened to the handpiece. Poor clinical performance will result if tip is not secured tightly to the handpiece. During any ultrasonic procedure, metal particles may result from inadvertent touching of the ultrasonic tip with a second instrument. Another potential source of metal particles resulting from any ultrasonic handpiece may be the result of ultrasonic energy causing micro abrasion of the ultrasonic tip.

Exceeding the recommended level of mmHg hPa with a 0. Consult Alcon Technical Service for additional information. Irreparable damage to the probe and tip can result if run dry. Connect pneumatic tubing connectors from vitrectomy probe to console prior to initiating prime of probe. This may require lowering cut rate to achieve good visualization. The port should always remain in open position in footpedal position 1. If cutting port is partially closed while in position 1, replace the probe.

If air bubbles are observed in the aspiration line or exiting the probe tip during priming, replace the probe. If a reduction of cutting capability or vacuum is observed during the surgical procedure, stop immediately and replace the probe. Ultrasonic cleaning will cause irreparable damage. Always clean handpiece over a surface cushioned with a pad or rubber mat. Never immerse the IOL injector in liquid after autoclaving; allow it to air cool for at least 15 minutes.

Quenching could result in a potentially hazardous condition for the patient. Appropriate use of injector handpiece settings is important for successful IOL implantation. Inappropriate use of settings may lead to a potentially hazardous condition for the patient.

The metal reusable plunger must be sterilized after each use. The reusable plunger is to be installed onto the handpiece or into the wrench prior to sterilization. Adjusting aspiration rates or vacuum limits above the preset values, or lowering the IOP or IV pole below the preset values, may cause chamber shallowing or collapse which may result in patient injury. IV pole rises automatically. To avoid stretching drip chamber tubing, and possibly pulling drip chamber out of bottle, tubing must hang freely with no interference.

Empirical numbers for bottle heights are not a replacement for competent surgical technique. The surgeon should visually and physically monitor intraocular pressure. Route the footswitch cable properly to avoid tripping. Damage may result. Never pick up or move the footswitch by the cable. Dropping or kicking the footswitch can cause irreparable damage. In the event of a persistent loss of aspiration during the application of phaco power, remove phaco power via footswitch control. Vacuum Tone A vacuum tone is provided.

The pitch will vary relative to the amount of vacuum. Excessive pressure in drain bag can result from exceeding its maximum capacity and potentially result in a hazardous condition for the patient. Failure of the HF surgical equipment coagulation circuitry could result in an unintended increase of output power.

Do not remove VideOverlay cover; there are no user-serviceable parts inside. Mismatch of consumable components and use of settings not specially adjusted for a particular combination of consumable components may create a patient hazard. Sterile disposable medical devices should not be reused! These components have been designed for one time use only; do not reuse. Potential risk from reuse or reprocessing the following products labeled for single use include: -.

Bipolar Coagulation Instruments - Thermal injury or electrical shock caused by a damaged bipolar instrument, and foreign particle introduction into the eye. The equipment used in conjunction with the Alcon disposables constitutes a complete surgical system.

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Web if you have questions, or want additional information, please contact your local alcon representative or the alcon technical services department at: Web site for international healthcare professionals only. Web if you have questions, or want additional information, please contact your local alcon representative or the alcon technical services department at:.

Web Learn more at myalcon today! Dmca Contact Privacy Policy Copyright. Web if you have questions, or want additional information, please contact your local alcon representative or the alcon technical services department at: Effect Of Iop Based Infusion System. Sign up or login below. Lehmann R.

Automated Patient Eye Level by Sensor based handpiece. Crandall AS. Brooks et al. Clinical Ophthalmology. Effect of IOP based infusion system with and without balanced phacotip on cumulative dissipated energy and estimated fluid usage in comparison to gravity fed infusion in torsional phacoemulsification.

Eye Vis Lond. Zacharias J. Laboratory assessment of thermal characteristics of three phacoemulsification tip designs operated using torsional ultrasound. Clin Ophthalmol. Vasavada AR, et al. Comparison of torsional and microburst longitudinal phacoemulsification: A prospective, randomized, masked clinical trial. Ophthalmic Surg Lasers Imaging. Mechanical model of human eye compliance for volumetric occlusion break surge measurements.

May 20, Narendran N, et al. The Cataract National Dataset electronic multicentre audit of 55 operations: Risk stratification for posterior capsule rupture and vitreous loss. Salowi MA, et al. Br J Ophthalmol. Please refer to relevant product directions for use or operator's manuals for list of indications, contraindications and warnings. Check if a local MyAlcon page for your country to access country product information.

This platform is intended to provide general product information for education and illustration purposes. It is not intended to provide information to the general public or medical advice. As product information, availability, indication and trade names may vary from country to country, the content of this site may not be fully in line with the approved or cleared product information in the country you are accessing from. Unless stated otherwise for specific product or event pages, the content on this site is based on the regulatory and legal principles applicable to the United Kingdom.

By clicking Yes. I confirm that: - I understand that this platform Is directed to Healthcare Professionals only and that I am a licensed Healthcare Professional.

Request An Evaluation. See More. Alcon Experience Academy For relevant training content from industry thought leaders.

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Web view and download alcon instruction manual online. Check if a local myalcon page for your country to access country product information. Web site for international healthcare professionals only.

Aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous. Web if you have questions, or want additional information, please contact your local alcon representative or the alcon technical services department at: Web site for international healthcare professionals only.

Web if you have questions, or want additional information, please contact your local alcon representative or the alcon technical services department at:. Web Crandall AS. Brooks et al. Clinical Ophthalmology. Effect of IOP based infusion system with and without balanced phacotip on cumulative dissipated energy and estimated fluid usage in comparison to gravity fed infusion in torsional phacoemulsification.

Eye Vis Lond. Zacharias J. Laboratory assessment of thermal characteristics of three phacoemulsification tip designs operated using torsional ultrasound. Clin Ophthalmol. Vasavada AR, et al. Comparison of torsional and microburst longitudinal phacoemulsification: A prospective, randomized, masked clinical trial. Ophthalmic Surg Lasers Imaging. Mechanical model of human eye compliance for volumetric occlusion break surge measurements.

May 20, Narendran N, et al. The Cataract National Dataset electronic multicentre audit of 55 operations: Risk stratification for posterior capsule rupture and vitreous loss. Salowi MA, et al. Br J Ophthalmol. Please refer to relevant product directions for use or operator's manuals for list of indications, contraindications and warnings.

Check if a local MyAlcon page for your country to access country product information. This platform is intended to provide general product information for education and illustration purposes. It is not intended to provide information to the general public or medical advice. As product information, availability, indication and trade names may vary from country to country, the content of this site may not be fully in line with the approved or cleared product information in the country you are accessing from.

Unless stated otherwise for specific product or event pages, the content on this site is based on the regulatory and legal principles applicable to the United Kingdom. By clicking Yes. I confirm that: - I understand that this platform Is directed to Healthcare Professionals only and that I am a licensed Healthcare Professional. Request An Evaluation. See More.

Alcon Experience Academy For relevant training content from industry thought leaders. Visit AEA Portal. References 1.