VMCNGPFSW1Centurion Vision System Footswitch

Operator's Manual Manufacturer: Alcon Laboratories, Inc. Alcon Laboratories (UK) Ltd. 6201 South Freeway Frimley Business Park Fort Worth, Texas 76134-2099 Frimley, Camberley U.S.A. Surrey, GU16 7SR, United Kingdom Produced By: Alcon Research, Ltd. 15800 Alton Parkway Irvine, California 92618-3818 U.S.A. Telephone: 949/753-1393 800/832-7827 FAX: 949/753-6614 8065751772, CATALOG NUMBER 905-2150-001 P4, TEXT ONLY © 2012 Novartis Directive 93/42/EEC EC REP ii 8065751772 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 905-2150- 001 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. Text Cover Sheet and pages i & ii also updated. June, 2012 P4 2012XXXX - On page 1.25 added IPX1 to remote control label. Text Cover Sheet and pages i & ii also updated. END USER LICENSE AGREEMENT: This product contains software licensed from Microsoft Corporation. * Registered in the U.S. Patent & Trademark Office. ** Mackool is a trademark of Richard J. Mackool, M.D. Cycoloy and Lexan are registered trademarks of Sabic Innovative Plastics IP vi 8065751772 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, Cautions, and Notes in this manual. A WARNING! statement is written to protect individuals from bodily harm. A Caution statement, with the CAUTION heading centered above the text, 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) 753-6614 CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a physician. 8065751772 1.3 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. 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. 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.). 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 Intended Use Environments The Centurion ® Vision System is intended for use in hospitals and ambulatory surgery centers. Phaco Handpiece Note Throughout the rest of this manual the CENTURION ® OZil ® 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 ® , AutoSert ® , or UltraChop refers to a display screen control used with a phaco handpiece, INTREPID ® AutoSert ® IOL injector, or ALCON ® UltraChopper ® tip, respectively. Abbreviation Descriptions Many of the abbreviations used in this manual and on the Centurion ® Vision System are described in Table 1-x. Icons are identified in Figure 1-x. 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 c…

Text truncated - open the document above for the full version.

WTD 12.7.3 FCC Compliance Opinion ALCO0149 Information about the Applicant Grantee (Company Name) Alcon Research Ltd. FCC Contact Person Sergey Marker Address 15800 Alton Parkway City, State, Zip Irvine, CA 92618-3818 Job Number ALCO0149 Model Cernturion Vision System Footswitch FCC ID VMCNGPFSW1 Agent Approval Type Original Equipment Class DCD - Part 15 Low Power Transmitter Below 1705 kHz Rule Part 15C Overview Centurion Vision System is an ophthalmic surgical instrument designed for cataract lens extraction and IOL injection using various hand pieces. The system includes a footswitch, FCC ID VMCNGPFSW1, to enable the surgeon to control multiple parameters during surgery. The footswitch includes an inductive charging system which also communicates with the console sending charging status data. The communications frequency is 115 kHz. This approval covers the 115 kHz communications inductive transmitter. The 50 kHz charger has been verified to FCC part 18. Confidentiality requested for allowed files. Request is properly addressed and referenced. Short term confidentiality requested. Recommendation All items have been resolved and completed to my satisfaction; therefore I recommend this application for approval. Signature Dave Tolman, TCB Committee 2/4/2013

FCC & IC label location

Internal Photo Console Rear Panel Charger Board Mounting (Console Side) Charger Coil (Console Side) Receiver Coil (Footswitch Side)

Antenna Description – Inductive Charging Loop Standard Applicable: For intentional device, according to FCC 47 CFR Section 15.203, “an intentional radiator shall be designed to ensure that no antenna other than that furnished by the responsible party shall be used with the device”. Antenna Connected Construction : RF transmitter antenna (internal) consists of two 11.4 cm diameter air-core coils that completely mounted onto the PWB with usable RF range of approximate 6 – 8 mm.

RF Exposure Compliance Per KDB 680106, the applicant made a KDB inquiry to obtain FCC guidance concerning the RF exposure requirements for their inductive charger. The guidance was followed; therefore the exposure condition documented herein is compliant with FCC rules. The following are the relevant excerpts and attachments from the KDB Inquiry FCC KDB Inquiry submitted 11/07/2011 “We are developing the contactless charger for a footswicth that is used in surgical instrument (ophthalmic). Charging frequency is 50kHz, and data transfer at frequency 125kHz - 134 KHz. Data tranfer at a very low rates to monitor battery status. Power transfer to charging battery 7 - 10 watts Max. OET Bulletin 56 - FCC limits for MPE starts from 300 kHz and above. But our application utilized 50 kHz. Does this contactless charging require MPE calculation? Can we test this system under Part 15 (instead of Part 15 and Part 18)? Please advice - thanks.” Reply from Customer 02/15/2012 Thank you for the response. Per requested , please see the attached detailed explanation of charging process. Please note that system is classified as mobile device (the charging process only occurred when the system is not in use, and is considered greater than 20cm distance from the user or bystander). The magnetic field strength calculated at distance 5 cm is 74 A/m (see attachment for details). What is MPE or SAR limits applicable for this application at the stated frequencies? Please advise Reply from Customer 04/23/2012 Sam, Thank you for speaking with me on Friday. This is Greg Kiemel of Northwest EMC. Alcon Labs has authorized me to contact the FCC to help them with this KDB Inquiry (please see attached authorization). Initially, Alcon submitted the inquiry on their own to seek guidance on their inductive charging circuit (per KDB 680106). Now, they've asked me to help them complete the inquiry process. Attached are two photos of their device. The doctor (user) and patient are on the side opposite of the charging loop which is located on the backside of the console (pedestal) near the floor. Several feet separate the user and patient from the charging loop. Alcon has specified previously that users and nearby persons will be greater than 20 cm from the loop. To charge the foot switch, it is removed from the floor on the user side of the console and placed in the vertical charging cradle (that contains the loop) on the rear of the console. It is not possible to use the foot switch while it is being charged. When the foot switch is in use, it is taken from the charging cradle and place on the floor on the user side. The charging loop is powered off when the foot switch is removed from the charging cradle. Per our conversation, Alcon has provided excerpts from the user manual that show the dimensions of the unit and provide insight into it's intended use. (Please see attachment). Based upon the distance from the user and nearby persons, and the inability to use the foot switch while it is being charged, we believe the RF exposure potential to users and bystanders is low. Any requested measurements should be 20 cm or greater away. We look forward to your updated compliance requirements for this device. Best regards, Greg Kiemel, Director of Engineering Northwest EMC, Inc. ph. 503-809-9854 email: [email protected] FCC Response 05/09/2012 General Information: Wireless battery chargers /wireless power pads operating at frequencies above 9 kHz are intentional radiators and are subject to either Part 15 and/or Part 18 of the FCC rules. The specific applicable rule part depends on how the device operates, and if there is communication between the charger and device being charged. It is possible for the device to be approved under Part 18 for the charging mode and Part 15 for the communications mode, if it can be shown that (1) the device complies with the relevant rule parts and (2) the functions are independent. Part 18 consumer devices can be either certified or approved under DoC, only after the required SAR guidance has been given ( . . by submitting an inquiry at www.fcc.gov/labhelp" . . ) and the necessary test requirements have been completed. Finally, it is possible that the power charging function could be approved under Part 15 rather than Part 18 if the device meets all of the requirements of the appropriate Part 15 rule. Now concerning your device, if Part 15 is applied to the charging, the rationale and analysis should be included in the RF exposure exhibit. If Part 18 is applied, TCB/manufacurere should keep a copy of the rationale and analysis in their equipment verification record (that is, update the descriptions and calculations etc). For Part 15, test lab can go to the TCB without a PBA to ensure that all rule are applied as mentioned above. 2.Please include proper instructions in the user manuals etc. to alert users to park the system in locations that can provide 20 cm between the outer surface of the charging foot switch and lingering bystanders to maintain RF exposure compliance. There is an error in the equation used to estimate the H-field strength; it should be a ?+? sign instead of ?x?. The numbers are OK, just the symbol is incorrect. Please correct. Please submit to TCB for approval upon review if all the above have been corrected. Analysis Submitted with KDB Inquiry Operational Parameters: Optical Sensor Range: approximately 10cm. Nominal Coil Separation: 7mm +/‐ 1 mm Charging Efficiency (Power into battery/transmitted power): 60% @ nominal separation Charging Frequency: 50 kHz Charge Rate: 10W Charging Current I: 5 A p‐p = 1.8 rms Number of turns in transmitting coil n: 11 Communication Frequency: 115 kHz Communicati on Charge Rate: 3W Communication Rate: ~200 bits per second (5ms/bit) Communication Payload: ~100 bits (duration ~0.5 sec) Charge Query Rate: 10sec‐30 sec. Recharge Time: approximately 10 hours for 2000 mAh 7.2V battery pack. Magnetic Field Calculation: At distance of z = 5 cm from the cent…

Text truncated - open the document above for the full version.

Alcon Laboratories, Inc. Centurion ® Vision System ® Report #: ALCO0149.1 Rev 01 Report Prepared By Northwest EMC Inc. NORTHWEST EMC – (888) 364-2378 – www.nwemc.com California – Minnesota – Oregon – New York – Washington 22975 NW Evergreen Parkway Suite 400 Hillsboro, Oregon 97124 Certificate of Test Last Date of Test: April 17, 2012 Alcon Laboratories, Inc. Model: Centurion ® Vision System ® Emissions Test Description Specification Test Method Pass/Fail Radiated Emissions FCC 15.109:2012 Class A ANSI C63.4:2009 Pass Radiated Spurious Emissions FCC 15.209:2012 ANSI C63.10:2009 Pass Conducted Emissions FCC 15.107:2012 Class A ANSI C63.4:2009 Pass Conducted Emissions FCC 15.207:2012 ANSI C63.10:2009 Pass Field Strength of Fundamental FCC 15.209:2012 ANSI C63.10:2009 Pass Deviations From Test Standards None Approved By: Don Facteau, IS Manager NVLAP Lab Code: 200676-0 Test Facility The measurement facility used to collect the data is located at: Northwest EMC, Inc. 41 Tesla Ave. Irvine, CA 92618 Phone: (503) 844-4066 Fax: 844-3826 This site has been fully described in a report filed with and accepted by the FCC (Federal Communications Commission) and Industry Canada (Site filing #2834B-1). This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government of the United States of America. Product compliance is the responsibility of the client, therefore the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. This Report may only be duplicated in its entirety. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. Revision History Revision 09/01/11 Revision Number Description Date Page Number 01 Revised Radiated Spurious Emissions data to only include results for the communication carrier frequency of 115 kHz. 1/31/13 12 01 Revised Field Strength of Fundamental data to only include results for the communication carrier frequency of 115 kHz. 1/31/13 19 Accreditations and Authorizations Revision 02/21/2012 United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Accredited by A2LA to ISO / IEC Guide 65 as a product certifier. This allows Northwest EMC to certify transmitters to FCC and IC specifications. NVLAP - Each laboratory is accredited by NVLAP to ISO 17025. The scope includes radio, ITE, and medical standards from around the world. See: http://www.nwemc.com/accreditations/ Canada IC - Recognized by Industry Canada as a Certification Body (CB). Certification chambers and Open Area Test Sites are filed with IC. European Union European Commission – Validated by the European Commission as a Conformity Assessment Body (CAB) under the EMC directive and as a Notified Body under the R&TTE Directive. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea KCC / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Hong Kong OFTA – Recognized by OFTA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. Russia GOST – Accredited by Certinform VNIINMASH, CERTINFO, SAMTES, and Federal CHEC to perform EMC and Hygienic testing for Information Technology products to GOST standards. Locations Revision 2/23/12 Oregon Labs EV01-EV12 22975 NW Evergreen Pkwy, #400 Hillsboro, OR 97124 (503) 844-4066 California Labs OC01-OC13 41 Tesla Irvine, CA 92618 (949) 861-8918 New York Labs WA01-WA04 4939 Jordan Rd. Elbridge, NY 13060 (315) 685-0796 Minnesota Labs MN01-MN08 9349 W Broadway Ave. Brooklyn Park, MN 55445 (763) 425-2281 Washington Labs SU01-SU07 14128 339 th Ave. SE Sultan, WA 98294 (360) 793-8675 VCCI C-1071, R-1025, G-84, C-2687, T-1658, R-2318 R-1943, G-85, C-2766, T-1659, G-548 R-3125, G-86, G-141, C-3464, T-1634 R-871, G-83, C-3265, T-1511 Industry Canada 2834D-1, 2834D-2 2834B-1, 2834B-2, 2834B-3 2834E-1 2834C-1 Product Description Revision 09/01/11 Client and Equipment Under Test (EUT) Information Company Name: Alcon Laboratories, Inc. Address: 15800 Alton Parkway City, State, Zip: Irvine, CA 92618-3818 Test Requested By: Sergey Marker Model: Centurion ® Vision System ® First Date of Test: April 11, 2012 Last Date of Test: April 17, 2012 Receipt Date of Samples: April 11, 2012 Equipment Design Stage: Production Equipment Condition: No Damage Information Provided by the Party Requesting the Test Functional Description of the EUT (Equipment Under Test): Centurion ® Vision System ® is an ophthalmic surgical instrument, a Phacoemulsification Aspiration (P.E.A.) platform. The NGP is used for irrigation/aspiration, Phaco-Fragmentation, capsulorhexis, intraocular lens injection, vitreous aspiration, cutting, and Bipolar. Testing Objective: To comply requirements for contactless battery charger (inductive power transmission). Configurations Revision 09/01/11 Configuration 1 ALCO0149 EUT Description Manufacturer Model/Part Number Serial Number Centurion ® Vision System ® Alcon Laboratories, Inc. 8065751763 1103473803X3 Centurion ® Footswitch Alcon Laboratories, Inc. 8065751762 1201677806X Cables Cable Type Shield Length (m) FerriteConnection 1 Connection 2 AC Cable Yes 4.7m No Centurion ® Vision System ® AC Mains Footswitch Cable Yes 3.7m No Centurion ® Footswitch Centurion ® Vision System ® PA = Cable is permanently attached to the device. Shielding and/or pres…

Text truncated - open the document above for the full version.

photo SAM_0184.JPG SAM_0185.JPG RADIATED EMISSIONS PSA-ESCI 2012.03.23 photo SAM_0194.JPG SAM_0195.JPG RADIATED EMISSIONS PSA-ESCI 2012.03.23 photo SAM_0196.JPG RADIATED EMISSIONS PSA-ESCI 2012.03.23 photo SAM_0199.JPG SAM_0197.JPG CONDUCTED EMISSIONS PSA-ESCI 2012.03.23 photo SAM_0198.JPG CONDUCTED EMISSIONS PSA-ESCI 2012.03.23