CENTURION Operators Manual Rev K Ver 3.02 Aug 2018

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

REVISION

AUG 2018

K

ECN NUMBER AND DESCRIPTION ECN 20180857 - Initial release of Centurion* Vision System Operator's Manual for systems with 3.02 software.

Revisions not used: A-J

END USER LICENSE AGREEMENT: This product contains software licensed from Microsoft Corporation.

* A trademark of Novartis. ** Trademarks are property of their respective owners. ii -- 905-2150-006.PDF, TEXT,MANUAL ,OP CENTURION 3.02, A.1 -- State: RELEASED -- Printed on: 8065754021 09-17-18 K

TABLE OF CONTENTS SECTION ONE - GENERAL INFORMATION

PAGE #

Overview of Centurion* Vision System... 1.1 Key Features of the Centurion* Vision System... 1.2 Indications For Use... 1.3 Intended Use 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*6VWHP:LUHOHVV&HUWL¿FDWLRQV... 1.9 Warnings And Cautions... 1.10 Phaco Handpiece Care... 1.12 Phaco Handpiece Tips... 1.13 8OWUDÀRZ* 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 &DXWHU'LDWKHUP&RDJXODWLRQ'H¿QLWLRQ... 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 6SHFL¿FDWLRQV... 1.23 Abbreviations Used With The Centurion* Vision System... 1.23 Icons Used With Centurion* Vision System... 1.24 Labeling on Centurion* Vision System... 1.25 Coagulation Power Outputs... 1.27 Summary of Alcon Default Settings... 1.28

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iii

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 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 8OWUDÀRZ* 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 &RQVXPDEOH3DFN&RQ¿JXUDWLRQV... 2.29 CustomPak 6XUJLFDO3URFHGXUH3DFN&RQ¿JXUDWLRQV... 2.29 Centurion* Fluidic Management System Packs... 2.30 +LJK'H¿QLWLRQ9LGHR2YHUOD 2SWLRQDO,WHP... 2.31 6HW8S+LJK'H¿QLWLRQ9LGHRYHUOD +'92 ,Q:LUHG&RQ¿JXUDWLRQ... 2.36

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SECTION TWO - DESCRIPTION

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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 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 8065754021 K -- 905-2150-006.PDF, TEXT,MANUAL ,OP CENTURION 3.02, A.1 -- State: RELEASED -- Printed on: 09-17-18

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SECTION TWO - DESCRIPTION

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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 3KDFR7LPLQJ&RQ¿JXUDWLRQV... 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 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 vi -- 905-2150-006.PDF, TEXT,MANUAL ,OP CENTURION 3.02, A.1 -- State: RELEASED -- Printed on: 8065754021 09-17-18 K

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 QRWDSSOWRRXUVSHFLÀFXQLW 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 OVERVIEW OF CENTURION* VISION SYSTEM Alcon’s 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 ,Q¿QLWL* 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 DVSLUDWHWKHOHQVLQWKHHHZKLOHUHSODFLQJDVSLUDWHGÀXLGDQGOHQVPDWHULDOZLWKEDODQFHG VDOWVROXWLRQ7KLVSURFHVVPDLQWDLQVDVWDEOH LQÀDWHG HHFKDPEHUYROXPH8VLQJVVWHP controls, the surgeon regulates the amount of energy applied to the handpiece tip, the rate of DVSLUDWLRQYDFXXPDQGWKHÀRZRIBSS* irrigating solution. The system includes a footswitch WRHQDEOHWKHVXUJHRQWRFRQWUROÀRZRIÀXLGLFVDVSLUDWLRQUDWHSKDFRSRZHUYLWUHFWRP 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 DFWLRQÁXLGLFVFRQWURO. - High performance Centurion* OZil* handpiece with ultrasonic torsional oscillations which can be used exclusively, combined, or alternated with traditional phaco. - High performance ,QÀQLWL* OZil* handpiece with ultrasonic torsional oscillations which can be used exclusively, combined, or alternated with traditional phaco. $GYDQFHGÀXLGLFVZLWKTXLFNVPRRWKFRQWURORIDVSLUDWLRQDQGYDFXXP Advanced Active Fluidics WHFKQRORJZLWKTXLFNVPRRWKFRQWURORILUULJDWLRQÀRZ controlled via the front panel, footswitch, or remote control. $XWRPDWHG ,9 SROH IRU WUDGLWLRQDO JUDYLW ÀXLGLFV FRQWUROOHG YLD WKH IURQW SDQHO footswitch, or remote control. 3URJUDPPDEOH,23WDUJHWVHWWLQJ )XOOSURJUDPPDEOHPXOWLPLFURSURFHVVRUFRQWURO 0RGXODUL]HGÀXLGLFFRQQHFWLRQVZLWKGLVSRVDEOH)OXLGLF0DQDJHPHQW6VWHP )06  (PXODWLRQRIYHQWXULOLNHÀXLGLFSHUIRUPDQFH 3RZHUDVVLVWHG,2/LQVHUWLRQEZDRIOLJKWZHLJKWDXWRFODYDEOHAutoSert* handpiece. $ELOLWWRGULYHDKLJKSHUIRUPDQFHCenturion*8OWUD9LW* vitrectomy guillotine cutter. %LSRODUFRDJXODWLRQFDSDELOLW Several traditional modalities of ultrasonic power control including continuous, pulsed, DQGEXUVWDSSOLFDWLRQRIXOWUDVRQLFSRZHUDVZHOODVGXWFFOHPDQDJHPHQW :LUHOHVV OLQHDU IRRWVZLWFK FRQWURO RI XOWUDVRQLF SRZHU LQ SKDFR VWHSV VRSKLVWLFDWHG FRQWUROORRSRIIHUVORZHQGFRQWURO  :LUHOHVVOLQHDUIRRWVZLWFKFRQWURORIDVSLUDWLRQÀRZUDWHLQ,$YLWDQGOHQVUHPRYDO steps. :LUHOHVVOLQHDUIRRWVZLWFKFRQWURORIYDFXXPLQ,$YLWDQGOHQVUHPRYDOVWHSV Wireless linear footswitch control of IOL insertion. 2QGHPDQGFRQWLQXRXVLUULJDWLRQ 3URJUDPPDEOHSUHVVXUL]HGUHÀX[YLDWKHIRRWVZLWFK $ELOLWWRVHW,23YDFXXPOHYHOVDQGDVSLUDWLRQÀRZUDWHVWRGHVLUHGOHYHOVLQSKDFR ,$DQGYLWVWHSV $ELOLWWRVZLWFKEHWZHHQVXUJLFDOVWHSVXVLQJWRXFKVFUHHQUHPRWHFRQWURORUIRRWVZLWFK (PLVVLRQRIYDULDEOHWRQHVIRUFRQ¿UPDWLRQRIVVWHPRSHUDWLRQDOVWDWXV 9RLFHFRQ¿UPDWLRQGXULQJVXUJLFDOVWHSRUPRGHFKDQJHV $UWLFXODWLQJÀDWVFUHHQDFWLYHPDWUL[FRORU/&'ZLWKWRXFKVFUHHQ +LJKWHFKJUDSKLFDOXVHULQWHUIDFH 0XOWLFKDQQHO,5UHPRWHFRQWURO

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Indications For Use The Centurion* 9LVLRQ 6VWHP LV LQGLFDWHG IRU HPXOVL¿FDWLRQ VHSDUDWLRQ LUULJDWLRQ DQG aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration DQG FXWWLQJ DVVRFLDWHG ZLWK DQWHULRU YLWUHFWRP ELSRODU FRDJXODWLRQ DQG LQWUDRFXODU OHQV injection. The AutoSert* ,2/ ,QMHFWRU +DQGSLHFH LV LQWHQGHG WR GHOLYHU TXDOL¿HG 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, 61$'61$7WKURXJK61$7DVZHOODVDSSURYHGAcrySof*OHQVHVWKDWDUHVSHFL¿FDOO LQGLFDWHGIRUXVHZLWKWKLVLQVHUWHUDVLQGLFDWHGLQWKHDSSURYHGODEHOLQJRIWKRVHOHQVHV The Centurion* Vision SystemLQFOXGLQJDFFHVVRULHVDSSURYHGE$OFRQFRQVWLWXWHVDFRPSOHWH VXUJLFDOVVWHPDQGLVLQWHQGHGH[FOXVLYHOIRUXVHEOLFHQVHGRSKWKDOPLFVXUJHRQVDQG WKHLUVXUJLFDOWHDPV7KHVHVXUJLFDOWHDPVDUHH[SHULHQFHGDWFRQGXFWLQJSKDFRHPXOVL¿FDWLRQ SURFHGXUHVLQDSURSHUOPDLQWDLQHGVXUJLFDOHQYLURQPHQW TXDOL¿HGSHUVRQQHODYDLODELOLW RIEDFNXSHTXLSPHQW DQGDUHIDPLOLDUZLWKWKHRSHUDWLRQRIWKHHTXLSPHQWXVHGDVRXWOLQHG LQRSHUDWRU VPDQXDOVDQGGLUHFWLRQVIRUXVH VHWXSFKHFNRXWSURFHGXUHVWREHFRPSOHWHG EHIRUHWKHVXUJLFDOSURFHGXUHSURFHVVLQJRIUHXVDEOHGHYLFHVPDLQWHQDQFHHWF  Patient selection for use with the Centurion* Vision System VXFKDVDJHRSKWKDOPLFSDWKRORJ DQGRWKHUIDFWRUV LVGHWHUPLQHGEWKHVXUJHRQ7KHJHQHUDOSDWLHQWDJHFDQUDQJHIURP QHZERUQWRJHULDWULFDOWKRXJKWKHUHKDYHEHHQVWXGLHVWKDWKDYHLGHQWL¿HGWKHPHDQDJH RISDWLHQWVWKDWXQGHUZHQWFDWDUDFWVXUJHUZDVUVPHQDQGUVZRPHQ Intended Use Environments The Centurion* 9LVLRQ 6VWHP LV LQWHQGHG IRU XVH LQ KRVSLWDOV FOLQLFV DQG DPEXODWRU surgery centers. Phaco Handpiece Note Throughout the rest of this manual the Centurion* OZil* handpiece, Centurion* Active Sentry* handpiece, and the ,Q¿QLWL* OZil*KDQGSLHFHZLOOEHUHIHUUHGWRDVSKDFRKDQGSLHFHVXQOHVV RQHRUWKHRWKHUPXVWEHUHIHUUHGWRH[FOXVLYHO Trademark Note $EXWWRQPRGHRUVWHSODEHOHGOZil* or AutoSert* refers to a display screen control used with a phaco handpiece or Intrepid* AutoSert* IOL injector, respectively. Abbreviation Descriptions 0DQRIWKHDEEUHYLDWLRQVXVHGLQWKLVPDQXDODQGRQWKHCenturion* Vision System are GHVFULEHGLQTable 1-5,FRQVDUHLGHQWL¿HGLQFigure 1-2. Accessory Equipment $FFHVVRUHTXLSPHQWFRQQHFWHGWRRUXVHGZLWKWKLVHTXLSPHQWPXVWEHFHUWL¿HGDFFRUGLQJ WRWKHUHVSHFWLYH,(&6WDQGDUG HJ,(&IRUGDWDSURFHVVLQJHTXLSPHQWDQG,(& IRUPHGLFDOHTXLSPHQW )XUWKHUPRUHDOOFRQ¿JXUDWLRQVVKDOOFRPSOZLWKFODXVH RI,(& DVDPHQGHG $QRQHFRQQHFWLQJDGGLWLRQDOHTXLSPHQWRURWKHUZLVH 1

³$JHDQGVH[SUR¿OHRISDWLHQWVKDYLQJFDWDUDFWVXUJHUEHWZHHQDQG´ 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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FDXVLQJDGLIIHUHQWVVWHPFRQ¿JXUDWLRQWKDQSURYLGHGE$OFRQLVUHVSRQVLEOHIRUFRQWLQXHG FRPSOLDQFHWRWKHUHTXLUHPHQWVRIFODXVHRI,(& DVDPHQGHG ,ILQGRXEW consult the Technical Services department or your local Alcon representative. Follow local governing ordinances and recycling plans regarding disposal or recycling of GHYLFHFRPSRQHQWVDQGSDFNDJLQJ User Information – Environmental Considerations 7KHHTXLSPHQWWKDWRXKDYHSXUFKDVHGUHTXLUHVWKHXVHRIQDWXUDOUHVRXUFHVIRULWVSURGXFWLRQ DQGRSHUDWLRQ7KLVHTXLSPHQWPDDOVRFRQWDLQKD]DUGRXVVXEVWDQFHVZKLFKFRXOGKDYH potential effect on the environment and human health if disposed of improperly. ,QRUGHUWRDYRLGWKHHQWURIDQVXFKVXEVWDQFHVLQWRRXUHQYLURQPHQWDQGWRSURPRWHQDWXUDO UHVRXUFHFRQVHUYDWLRQSOHDVHLQVWDOOPDLQWDLQDQGRSHUDWHWKHHTXLSPHQWLQDFFRUGDQFHZLWK WKHLQVWUXFWLRQV,QIRUPDWLRQRQWKHORFDWLRQRIKD]DUGRXVVXEVWDQFHVUHVRXUFHFRQVXPSWLRQ DQGHPLVVLRQVRIWKHHTXLSPHQWFDQEHIRXQGWKURXJKRXWWKLV2SHUDWRU V0DQXDO3OHDVHXVH WKHDSSURSULDWHWDNHEDFNVVWHPV6XFKWDNHEDFNVVWHPVUHXVHRUUHFFOHPDQRIWKH PDWHULDOVLQRXUHQGRIOLIHHTXLSPHQWLQDEHQH¿FLDOZD3OHDVHFRQWDFWRXUORFDO$OFRQ RI¿FHIRUDVVLVWDQFHLQWDNHEDFNRSWLRQVWKURXJK$OFRQRURWKHUSURYLGHUV 7KHFURVVHGELQVPEROORFDWHGRQWKLVHTXLSPHQWUHPLQGVRXWRXVHWDNHEDFNVVWHPV ZKLOH DOVR HPSKDVL]LQJ WKH UHTXLUHPHQW WR FROOHFW ZDVWH HTXLSPHQW VHSDUDWHO DQG QRW GLVSRVHRILWDVXQVRUWHGPXQLFLSDOZDVWH7KH3EQRWDWLRQLISUHVHQWLQGLFDWHVWKDWWKH ODEHOHGGHYLFHFRQWDLQVJUHDWHUWKDQOHDG Pb

,IRXQHHGPRUHLQIRUPDWLRQRQWKHFROOHFWLRQUHXVHRUUHFFOHVVWHPVDYDLODEOHWRRX SOHDVHFRQWDFWRXUORFDORUUHJLRQDOZDVWHDGPLQLVWUDWLRQRUFRQWDFWRXUORFDO$OFRQRI¿FH for more information. Universal Precautions 8QLYHUVDOSUHFDXWLRQVVKDOOEHREVHUYHGEDOOSHRSOHZKRFRPHLQFRQWDFWZLWKWKHLQVWUXPHQW DQGRUDFFHVVRULHVWRKHOSSUHYHQWWKHLUH[SRVXUHWREORRGERUQHSDWKRJHQVDQGRURWKHU SRWHQWLDOOLQIHFWLRXVPDWHULDOV,QDQFLUFXPVWDQFHZKHUHLQWKHH[DFWVWDWXVRIEORRGRU ERGÀXLGVWLVVXHVHQFRXQWHUHGDUHXQNQRZQLWVKDOOEHXQLIRUPOFRQVLGHUHGSRWHQWLDOO infectious and handled in accordance with OSHA or your own national guidelines. EMC Statements ,WLVLPSRUWDQWWRLQVWDOODQGXVHWKHHTXLSPHQWLQDFFRUGDQFHZLWKWKHLQVWUXFWLRQVLQRUGHU WRSUHYHQWKDUPIXOLQWHUIHUHQFHZLWKRWKHUGHYLFHVLQWKHYLFLQLW,IWKLVHTXLSPHQWFDXVHV KDUPIXOLQWHUIHUHQFHWRRWKHUGHYLFHV GHWHUPLQHGEWXUQLQJHTXLSPHQWRIIDQGRQ WKH XVHULVHQFRXUDJHGWRWUWRFRUUHFWLQWHUIHUHQFHERQHRUPRUHRIWKHIROORZLQJPHDVXUHV •

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8VHUVVKRXOGEHDZDUHRINQRZQ5)VRXUFHVVXFKDVUDGLRRU79VWDWLRQVDQGKDQGKHOG RUPRELOHWZRZDUDGLRVDQGFRQVLGHUWKHPZKHQLQVWDOOLQJDPHGLFDOGHYLFHRUVVWHP 3RUWDEOHDQGPRELOH5)FRPPXQLFDWLRQVHTXLSPHQWVXFKDVFHOOXODUWHOHSKRQHVFDQDIIHFW PHGLFDOHOHFWULFDOHTXLSPHQW Be aware that adding accessories or components, or modifying the medical device or system, PDGHJUDGHWKH(0,SHUIRUPDQFH&RQVXOWZLWKTXDOL¿HGSHUVRQQHOUHJDUGLQJFKDQJHVWR WKHVVWHPFRQ¿JXUDWLRQ WARNINGS! •

7KHXVHRIDFFHVVRULHVWUDQVGXFHUVDQGFDEOHVRWKHUWKDQWKRVHVSHFL¿HGZLWK 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 YHULIQRUPDORSHUDWLRQLQWKHFRQ¿JXUDWLRQLQZKLFKLWZLOOEHXVHG

•

0$*1(7,&$1'(/(&75,&$/,17(5)(5(1&(0DJQHWLFDQGHOHFWULFDO¿HOGVDUH 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* 9LVLRQ 6VWHP LV GHVLJQHG WR ZRUN LQ 3URIHVVLRQDO +HDOWKFDUH IDFLOLW environment. Table 1-1

Guidance and Manufacturer's Declaration - Electromagnetic Emissions 7KH&HQWXULRQ 9LVLRQ6VWHPLVLQWHQGHGIRUXVHLQWKHHOHFWURPDJQHWLFHQYLURQPHQWVSHFL¿HGEHORZ 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

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

9ROWDJHÀXFWXDWLRQV Flicker emissions IEC 61000-3-3

Complies

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. 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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1.5

Table 1-2

Guidance and Manufacturer's Declaration - Electromagnetic Immunity The Centurion 9LVLRQ6VWHPLVLQWHQGHGIRUXVHLQWKHHOHFWURPDJQHWLFHQYLURQPHQWVSHFL¿HGEHORZ7KH 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

)ORRUVVKRXOGEHZRRGFRQFUHWHRUFHUDPLFWLOH,IÀRRUV 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 ĭDQJOHV

0% Ut for 0.5 cycle at 8 ĭDQJOHV

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

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

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.

0% for 250/300 cycles

0% for 250/300 cycles

Power frequency (50/60 Hz) PDJQHWLF¿HOG IEC 61000-4-8

3 A/m, 50/60 Hz

3 A/m, 50/60 Hz

3RZHU IUHTXHQF PDJQHWLF ¿HOGV VKRXOG EH DW OHYHOV characteristic of a typical location in a typical hospital (including ambulatory surgery center) environment.

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

7KH,60 LQGXVWULDOVFLHQWL¿FDQGPHGLFDO 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)

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

7KH,0081,7<7(67/(9(/6VSHFL¿HGLQWKHWDEOHZHUH FDOFXODWHGXVLQJWKHIROORZLQJHTXDWLRQ( ¥3 G 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* 9LVLRQ 6VWHP LQFOXGLQJ FDEOHV VSHFL¿HG E WKH PDQXIDFWXUHU 2WKHUZLVH GHJUDGDWLRQ RI WKH performance of this equipment could result.

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Equipment Contains Radio Transmitters The Centurion* 9LVLRQ 6VWHP LV D PHGLFDO GHYLFH GHVLJQHG IRU ,QGRRU 8VH 2QO WKDW LQFRUSRUDWHVVKRUWUDQJHIUHTXHQFUDGLRWUDQVPLWWHUVIRUXVHVROHOEWKHCenturion* system IRUFRPPXQLFDWLRQZLWKVVWHPFRPSRQHQWV7KHVHVKRUWUDQJHIUHTXHQFUDGLRWUDQVPLWWHUV PHHWWKH(8DQG$)7$FRXQWULHVUHTXLUHPHQWV7KHDUHDOVR)&&,&5('DQG-DSDQHVH 5DGLR/DZFRPSOLDQW •

•

•

=LJ%HH5DGLR0RGXODU &RPPXQLFDWLRQOLQNZLWK)RRWVZLWFK6*6DQG0HGLD&HQWHU -

Frequency or frequency band of transmission and reception: 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)

:LUHOHVV/$1GHYLFH 2SWLRQDO -

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

-

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

-

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

Wireless Footswitch Charger -

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

-

Frequency or frequency band communication transmission: 115 kHz

-

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

-

7KH(IIHFWLYH5DGLDWHG3RZHU (53 G%P ƫ:

USA – Federal Communications Commission (FCC) 7KLVGHYLFHFRPSOLHVZLWKSDUWRIWKH)&&5XOHV2SHUDWLRQLVVXEMHFWWRWKHIROORZLQJ WZRFRQGLWLRQV  7KLVGHYLFHPDQRWFDXVHKDUPIXOLQWHUIHUHQFHDQG  WKLVGHYLFHPXVW accept any interference received, including interference that may cause undesired operation. CAUTION &KDQJHRUPRGL¿FDWLRQVPDGHWRWKLVHTXLSPHQW LQFOXGLQJDQWHQQD QRWH[SUHVVO approved by Alcon may void the FCC authorization to operate this equipment.

)&&5DGLDWLRQ([SRVXUH6WDWHPHQW 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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Summary of Centurion*6VWHP:LUHOHVV&HUWLÀFDWLRQV United States FCC ID: VMCNGPFSW1 Contains FCC ID: RI7XE61 Contains FCC ID: N6C-SDMAN

Canada IC: 7345A-NGPFSW1 Contains IC: 5131A-XE61 Contains IC: 4908B-SDMAN

Korea

Taiwan

MSIP-CRI-TCS-XE61-24 MSIP-CRM-Alc-8065751763

CCAJ14LP1010T6 CCAJ14LP2610T9 Japan 209-J00082

Europe

209-J00083 007-AA0098 Australia

Table 1-3 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. Material Location

Hazardous Substances Contained

Printed Circuit Board Assembly

Lead, Polybrominated Biphenyls (PBB)

Other Electrical / Electronic Device

Lead, Polybrominated Biphenyls (PBB)

Cable Assembly

Lead

Power Supply

Lead, Polybrominated Biphenyls (PBB)

Host PC Module

Lead, Polybrominated Biphenyls (PBB)

Liquid Crystal Display

Lead

Battery

Lead, Lithium, Zn/MnO2

IV Pole Assembly

Lead, Polybrominated Biphenyls (PBB)

Remote Control

Lead

Fluidics Assembly

Lead

Pneumatic Assembly

Lead

8065754021 K -- 905-2150-006.PDF, TEXT,MANUAL ,OP CENTURION 3.02, A.1 -- State: RELEASED -- Printed on: 09-17-18

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WARNINGS AND CAUTIONS 0DQRIWKHVHZDUQLQJVDUHVWDWHGHOVHZKHUHLQWKLVPDQXDOKRZHYHUIRUHDVUHIHUHQFH they DUHUHSHDWHGLQJUHDWHUGHWDLOKHUH,IDGGLWLRQDOLQIRUPDWLRQLVUHTXLUHGSOHDVHcontact your ORFDO$OFRQVHUYLFHUHSUHVHQWDWLYHRUWKH7HFKQLFDO6HUYLFHV'HSDUWPHQW 7KHUHDUHQRXVHUVHUYLFHDEOHFRPSRQHQWVLQVLGHWKHCenturion* Vision System console or IRRWVZLWFK5HIHUDOOVHUYLFHLVVXHVWRRXUIDFWRUWUDLQHG$OFRQVHUYLFHHQJLQHHU WARNINGS! •

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.

•

)RUFRQWLQXHGSURWHFWLRQDJDLQVWULVNRI¿UHUHSODFHRQOZLWKVDPHWSHDQGUDWLQJ of fuse.

•

$TXDOL¿HGWHFKQLFLDQPXVWSHUIRUPDYLVXDOLQVSHFWLRQRIWKHIROORZLQJFRPSRQHQWV every twelve months: - Warning Labels (see Figure 1-3) - Power Cord - Fuses

•

,QFDVHRIDGH¿FLHQFGRQRWXVHWKHVVWHPFDOO$OFRQ7HFKQLFDO6HUYLFHV

•

$ TXDOL¿HG WHFKQLFLDQ PXVW FKHFN JURXQG FRQWLQXLW DQG OHDNDJH FXUUHQW HYHU 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.

•

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.

•

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 use the Centurion*9LVLRQ6VWHPQHDUÀDPPDEOHDQHVWKHWLFV

•

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.

•

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

•

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

•

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

•

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

•

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

•

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

1.10 -- 905-2150-006.PDF, TEXT,MANUAL ,OP CENTURION 3.02, A.1 -- State: RELEASED -- Printed on: 8065754021 09-17-18 K

WARNINGS! •

Appropriate use of Centurion* Vision System parameters and accessories is LPSRUWDQWIRUVXFFHVVIXOSURFHGXUHV8VHRIORZYDFXXPOLPLWVORZÀRZUDWHVORZ bottle heights, high power settings, extended power usage, power usage during RFFOXVLRQ FRQGLWLRQV EHHSLQJ WRQHV  IDLOXUH WR VXI¿FLHQWO DVSLUDWH YLVFRHODVWLF prior to using power, excessively tight incisions, and combinations of the above DFWLRQVPDUHVXOWLQVLJQL¿FDQWWHPSHUDWXUHLQFUHDVHVDWLQFLVLRQVLWHDQGLQVLGH the eye, and lead to severe thermal eye tissue damage.

•

*RRG FOLQLFDO SUDFWLFH GLFWDWHV WHVWLQJ IRU DGHTXDWH LUULJDWLRQ DVSLUDWLRQ ÀRZ UHÀX[DQGRSHUDWLRQDVDSSOLFDEOHIRUHDFKKDQGSLHFHSULRUWRHQWHULQJHH

•

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

•

If the handpiece test chamber is collapsed after tuning, there is a potential of low LUULJDWLRQÀRZWKURXJKWKHKDQGSLHFHDQGPDUHVXOWLQDÀXLGLFLPEDODQFH7KLVLQ turn, may cause a shallowing or collapsing of the anterior chamber.

•

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.

•

8VHRI%66 LUULJDWLQJÀXLGEDJVRWKHUWKDQWKRVHDSSURYHGE$OFRQIRUXVHLQWKH Active Fluidics* system can result in patient injury or system damage.

•

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

•

Do not remove the FMS during the surgical procedure.

•

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

•

Improper handling or removal of dual irrigation handpiece tip from eye may cause GUDLQLQJRIWKHÀXLGLFVVVWHP

CAUTIONS •

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.

•

0RGL¿FDWLRQRIWKHHTXLSPHQWLV127DOORZHGZLWKRXWSULRUDXWKRUL]DWLRQIURPWKH PDQXIDFWXUHU,IWKLVHTXLSPHQWLVPRGL¿HGDSSURSULDWHLQVSHFWLRQDQGWHVWLQJPXVW 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 spray any liquid (i.e. cleaning solution or water) upward into the console vents.

•

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.

•

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.

8065754021 K -- 905-2150-006.PDF, TEXT,MANUAL ,OP CENTURION 3.02, A.1 -- State: RELEASED -- Printed on: 09-17-18

1.11

CAUTIONS •

Grounding reliability can only be achieved when equipment is connected to an equivalent receptacle marked hospital grade.

•

5LVNRIEXUQVDQG¿UH'R1RWXVHQHDUFRQGXFWLYHPDWHULDOV5HQHZHOHFWURGHFDEOHV upon evidence of deterioration.

Phaco Handpiece Care 3KDFRKDQGSLHFHVDUHVXUJLFDOLQVWUXPHQWVDQGPXVWEHKDQGOHGZLWKFDUH7KHKDQGSLHFH WLSVKRXOGQRWWRXFKDQVROLGREMHFWZKLOHLQRSHUDWLRQ,PPHGLDWHOIROORZLQJVXUJHU WKHKDQGSLHFHPXVWEHWKRURXJKOFOHDQHG%HVXUHKDQGSLHFHFRQQHFWRULVFRPSOHWHOGU EHIRUHFRQQHFWLQJLWWRFRQVROH)RUFOHDQLQJDQGVWHULOL]DWLRQSURFHGXUHVVHHWKH'LUHFWLRQV IRU8VH ')8 VXSSOLHGZLWKWKHKDQGSLHFH WARNINGS! •

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.

•

8VHRIDSKDFRKDQGSLHFHLQWKHDEVHQFHRILUULJDWLRQÀRZDQGRULQWKHSUHVHQFH RIUHGXFHGRUORVWDVSLUDWLRQÀRZDQGRUVLGHZDVRULHQWDWLRQRIWKH.HOPDQ DQG OZil* 12 tips can cause excessive heating and potential thermal injury to adjacent eye tissues.

•

Appropriate use of Centurion* Vision System parameters and accessories is LPSRUWDQWIRUVXFFHVVIXOSURFHGXUHV8VHRIORZYDFXXPOLPLWVORZÀRZUDWHVORZ bottle heights, high power settings, extended power usage, power usage during RFFOXVLRQ FRQGLWLRQV EHHSLQJ WRQHV  IDLOXUH WR VXI¿FLHQWO DVSLUDWH YLVFRHODVWLF prior to using power, excessively tight incisions, and combinations of the above DFWLRQVPDUHVXOWLQVLJQL¿FDQWWHPSHUDWXUHLQFUHDVHVDWLQFLVLRQVLWHDQGLQVLGH the eye, and lead to severe thermal eye tissue damage.

•

Use of an ultrasonic handpiece other than an OZil* torsional or Active Sentry* handpiece, or use of a handpiece repaired without Alcon authorization, is not permitted, and may result in patient injury, including potential shock hazard to patient and/or operator.

•

The U/S tips supplied in the Centurion* Vision System pack are only to be used on an OZil* torsional handpiece. Each U/S tip is intended to be used only once per case, and then disposed of according to local governing ordinances.

•

0LVPDWFKLQJ86WLSVDQGLQIXVLRQVOHHYHVPDFUHDWHSRWHQWLDOOKD]DUGRXVÀXLGLF imbalances.

•

Directing energy toward non-lens material, such as iris or capsule, may cause mechanical and/or thermal tissue damage.

•

Perform visual inspection of accessories for burs or bent tips prior to use.

•

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

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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. 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.

•

(QVXUHWKDWWHVWFKDPEHULV¿OOHGZLWKBSS* sterile irrigating solution before tuning the phaco handpiece. Tuning a handpiece dry may result in premature tip failure and breakage.

•

Quenching a hot handpiece in water can cause damage and will void warranty.

•

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. If not securely attached, an HUURUPDEHJHQHUDWHGDQGRULQDGHTXDWHWXQLQJZLOORFFXU(QVXUHWKDWWKHWLSLVQRWWRR WLJKWVRWKDWLWFDQEHUHPRYHGDIWHUXVH 8VHRIDWRRORWKHUWKDQWLSZUHQFKHVVXSSOLHGE$OFRQPDFDXVHGDPDJHWRWKHWLSDQG or handpiece. WARNINGS! •

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.

8065754021 K -- 905-2150-006.PDF, TEXT,MANUAL ,OP CENTURION 3.02, A.1 -- State: RELEASED -- Printed on: 09-17-18

1.13