AMO GEMINI COMBINED EYE-SURGERY SYSTEM Installation and Operating Manual Rev 8 Jan 2005

Title Part number Revision Version Software version Date of print Product Manufacturer Licensee and distributor

AMO® GEMINITM Combined eye-surgery System – Installation and operating Manual 172101u 8 3.0 Jaunuary 14th 2005 AMO® GEMINITM Optikon 2000 S.p.A. via del Casale di Settebagni Roma, Italy Advanced Medical Optics, Inc. 1700 East St. Andrew Place, Santa Ana, CA 92705 U.S.A.

Customer Service

To order accessories, please, call AMO customer service department or your local AMO representative.

Technical service For service assistance, please, call AMO Technical Service or your local AMO representative.

Europe, Africa and Middle East - AMO Surgical Systems Services

Phone +49-7243-729-444 E-mail [email protected]

Canada - Technical Support

Phone +1-800-668-6477 +1-800-449-3060

Japan

Phone +81-3-5402-8930 FAX +81-3-5402-8978

Asia Pacific

Local AMO representative

USA - Equipment/Supplies

Phone +1-800-366-6954 +1-800-449-3060

Local AMO representative

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TABLE OF CONTENTS 1. 2. 3. 4. 5.

6.

7.

8. 9.

Page

DISCLAIMER... 3 LIMITED WARRANTY CONDITIONS... 4 WARNINGS... 5 SYMBOLS ON MARKING ... 9 GENERAL INFORMATION... 10 5.1 INTRODUCTION ... 10 5.2 SYSTEM DESCRIPTION ... 12 5.3 TECHNICAL SPECIFICATIONS ... 13 5.4 CLEANING AND STERILIZATION... 17 INSTALLATION AND MAINTENANCE ... 18 6.1 INTRODUCTION ... 18 6.2 INITIAL INSPECTION... 18 6.3 INSTALLATION ... 19 6.4 MAINTENANCE AND CARE... 20 6.5 SHUT DOWN PROCEDURE ... 21 EQUIPMENT OPERATION ... 22 7.1 EQUIPMENT DESCRIPTION ... 22 7.2 EQUIPMENT LAYOUT ... 26 7.3 USER INTERFACE... 30 7.4 VOICE PROMPTING ... 32 7.5 IRRIGATION / ASPIRATION SYSTEM SET-UP ... 32 7.6 BIPOLAR DIATHERMY ... 33 7.7 I/A (Irrigation/Aspiration) ... 35 7.8 PHACOEMULSIFICATION ... 37 7.9 VITRECTOMY ... 41 7.10 MICROSCISSORS... 43 7.11 ILLUMINATION... 45 7.12 TAMPONADE ... 46 7.13 AUTOMATIC I.V. POLE ... 49 7.14 FOOTSWITCH... 49 7.15 TO RECALL OR STORE A PROGRAM... 53 WARNING AND ERROR MESSAGES ... 56 TROUBLESHOOTING GUIDE ... 57

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1. DISCLAIMER

The OPTIKON S.p.A. manufactures surgical and diagnostical devices for ophthalmology. Our international reputation for product quality and performance is well established. We feel we have the additional obligation to provide product information and WARNINGS to customers to assist them in utilizing our products in a reasonable and safe manner. The user of "AMO® GEMINITM" surgery system is cautioned to review specific warnings found in this manual. In no event shall OPTIKON S.p.A. be liable or responsible to user for any injury, and incidental or consequential damages. It is incumbent upon user to provide its personnel with a thorough understanding of the instrument operation before use. OPTIKON S.p.A. reserves the right to revise this manual without notice, for any reason. This includes but is not limited to, utilization of advance in the state of the art and changes thereof. Liability for difficulties arising from unknown or unforeseen technical limitation is disclaimed.

OPTIKON 2000 S.p.A. Via del Casale di Settebagni, 13 00138 Roma Italy

Teleph. +39 06 8888355 or +39 06 8888366 Fax. +39 06 8888388 e-mail [email protected]

NOTICE:

INFORMATION CONTAINED IN THIS MANUAL IS PROPRIETARY WITH OPTIKON S.p.A. REPRODUCTION OF ANY PART OR WHOLE MAY ONLY BE PERFORMED WITH WRITTEN PERMISSION FROM OPTIKON S.p.A.

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2. LIMITED WARRANTY CONDITIONS OPTIKON instruments and accessories are guaranteed against defective workmanship and faulty parts for ONE YEAR, from the date of the invoice. Warranty on consumable materials is limited to the first use. All items under guarantee will be repaired or replaced free of charge. Warranty includes the research of causes of the faults, reparation of the defect and a final inspection of the unit, or part(s). This warranty does not cover the results of misuse, accident, abuse and tampering or alteration done by anyone other than personnel authorized by OPTIKON S.p.A. OPTIKON reserves the right to ascertain, in case of faults, whether or not the instrument(s) and/or its accessories have been altered, tampered with, in any way, or have been damaged by improper use. The opinion of OPTIKON laboratory is incontestable. OPTIKON also reserves the right to modify the instrument and/or its accessories whenever operating techniques necessitate modification(s). No warranty will be recognized if: 1) Serial number of the instrument and/or accessories attributed by OPTIKON is missing, tampered and/or not clearly readable. 2) Payment has not been effected in accordance with the payment conditions specified in the respective invoice. In case of an expressly requested intervention of our technicians, all travel and hotel expenses will be debited to the client. OPTIKON cannot be held liable for damages caused by transportation. We recommend checking any consignment immediately upon receipt for possible damage that may have occurred during transport. If this is the case, the customer should apply at once to the carrier that handled the consignment (mail, railways or forwarding agents) and have an appropriate certificate established. Without documentary evidence, claim cannot be filed. OPTIKON S.p.A. declares to be liable for safety, reliability and performance only if: o

upgrades, calibrations, repairs are carried out by OPTIKON authorized personnel

and if: o

the mains electric installation to which the console is connected complies with the I.E.C. or UL Safety Regulations.

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3. WARNINGS Care in the handling of "AMO® GEMINITM" surgery system is one of the first principles in an operatingroom, and no amount of warnings can take place of such care.

NOTE: THIS INFORMATION IS BELIEVED TO BE CURRENT AT THE TIME OF PUBLICATION, BUT IT IS PROVIDED WITHOUT WARRANTY OF ANY KIND AND WE ASSUME NO RESPONSIBILITY WITH RESPECT THERETO. The following warnings will aid the user to provide adequate safeguards to assure safe, trouble free performance: 1) ALL MEDICAL PERSONNEL SHOULD READ AND UNDERSTAND THE INSTRUCTIONS IN THIS MANUAL PRIOR TO THE SYSTEM BEING USED. DO NOT ATTEMPT TO USE THE SYSTEM IF IT FAILS TO PERFORM AS SET OUT IN THE OPERATION PROCEDURES, IN THIS MANUAL. 2) USE OF THE SYSTEM SHOULD BE RESTRICTED TO QUALIFIED MEDICAL PERSONNEL WHO FULLY UNDERSTAND POTENTIAL RISKS CONNECTED WITH THE USE OF THE INSTRUMENT AND ARE TRAINED ON THE PREVENTION AND MANAGEMENT OF POSSIBLE CLINICAL COMPLICATIONS. 3) USE OF THIS SYSTEM IS A MATTER OF PROFESSIONAL MEDICAL JUDGMENT IN ALL CASES. OPTIKON S.p.A. IS NOT RESPONSIBLE FOR ANY CLINICAL PROBLEM RESULTING FROM MISHANDLING THIS INSTRUMENT AND MAKES NO MEDICAL RECOMMENDATIONS. 4) THE SYSTEM SHOULD NEVER BE USED IN THE PRESENCE OF FLAMMABLE ANAESTHETICS, DISINFECTING AGENTS, CLEANING AGENTS, ETC., DUE TO POSSIBLE FIRES OR EXPLOSION. 5) TO REDUCE THE RISK OF ELECTRIC SHOCK, DO NOT REMOVE COVER REFER SERVICING TO QUALIFIED SERVICE PERSONNEL. ®

TM

6) THE "AMO GEMINI " CONTROL CONSOLE SHOULD BE CONNECTED TO A MAINS SUPPLY ONLY AS MARKED ON THE REAR PANEL. TO GUARANTEE SAFETY, A HOSPITAL GRADE POWER CORD AND PLUG MUST BE USED, THE UNIT MUST BE GROUNDED. 7) FOR OPERATING SAFETY DO NOT INSTALL THE SYSTEM IN A LOCATION WHERE IT WILL BE EXPOSED TO HEATING EQUIPMENT OR RADIATORS, DIRECT SUNLIGHT, OR ANY OTHER SOURCE OF EXTREMELY HIGH TEMPERATURES. 8) DO NOT INSTALL THE "AMO® GEMINITM" SYSTEM IN SUCH A WAY THAT THE VENTILATING OPENINGS ARE BLOCKED. 9) BE SURE THAT THE POWER SWITCH ON THE CONTROL CONSOLE IS OFF WHEN PLUGGING IN, OR REMOVING THE POWER CABLE FROM A WALL OUTLET. Pag. 5 of 62

10) TURN OFF THE MAIN POWER SWITCH WHENEVER THE AMO® GEMINITM UNIT IS NOT IN USE. 11) THE COMPUTER UPLINK CONNECTION IS INTENDED FOR SERVICE PROCEDURES ONLY: DO NOT CONNECT ANY EXTERNAL DEVICE TO THE REAR PANEL “COMPUTER UPLINK” SOCKET DURING THE USE OF THE EQUIPMENT IN SURGERY. 12) RISK OF BURNS OR FIRE; DO NOT USE DIATHERMY NEAR CONDUCTIVE MATERIALS SUCH AS METAL BED PARTS, INNER-SPRING MATTRESSES, AND THE LIKE. RENEW ELECTRODE CABLES UPON EVIDENCE OF DETERIORATION. 13) SEVERE RF BURNS CAN RESULT IF THE DIATHERMY OUTPUT CURRENT IS DIVERTED TO THE OPERATOR BY CARELESS HANDLING. 14) WHEN THE BIPOLAR DIATHERMY HANDPIECE AND A MONITORING SYSTEM ARE USED AT THE SAME TIME, ALL THE ELECTRODES OF THE MONITORING SYSTEM THAT ARE NOT PROTECTED BY RESISTORS OR HIGH FREQUENCY INDUCTORS SHOULD BE PLACED AS FAR AWAY AS POSSIBLE FROM THE DIATHERMY ELECTRODES. 15) THE CABLE OF THE BIPOLAR DIATHERMY HANDPIECE SHOULD NOT TOUCH THE PATIENT OR OTHER CABLES. 16) ALWAYS USE THE LOWEST OUTPUT DIATHERMY POWER LEVEL WHICH IS COMPATIBLE TO THE SURGICAL APPLICATION. 17) AN EVIDENT LOW OUTPUT LEVEL OR A FAULTY OPERATION OF THE BIPOLAR DIATHERMY HANDPIECE, EVEN THOUGH THE INSTRUMENT HAS BEEN SET FOR A NORMAL USE, MAY INDICATE A BAD CONTACT IN THE ELECTRODES CONNECTION. 18) DURING BIPOLAR DIATHERMY HANDPIECE OPERATION, DO NOT USE FLAMMABLE ANAESTHETICS NITROGEN MONOXIDE, OXYGEN, UNLESS THEY ARE VENTED BY A SUITABLE ASPIRATION SYSTEM. 19) FLAMMABLE MATERIALS SUCH AS DISINFECTING AGENTS AND CLEANING AGENTS SHOULD BE EVAPORATED BEFORE USING THE BIPOLAR DIATHERMY HANDPIECE. SOME MATERIALS SUCH AS COTTON WOOL OR GAUZE, IF SOAKED WITH OXYGEN, CAN CATCH FIRE BECAUSE OF THE SPARKS CAUSED BY THE INSTRUMENT IN ITS NORMAL USE. 20) THERE IS A POSSIBLE RISK FOR PATIENTS CARRYING CARDIAC STIMULATOR OR STIMULATING ELECTRODES BECAUSE OF RF INTERFERENCE CAUSED BY DIATHERMY GENERATOR. THE STIMULATOR ITSELF CAN FAIL. SHOULD ANY DOUBT ARISE, APPLY TO THE CARDIOLOGY DIVISION FOR ADVICE. 21) CAUTION: POSSIBLE INTERFERENCE WITH OTHER MEDICAL EQUIPMENT WHEN THE BIPOLAR DIATHERMY HANDPIECE IS IN USE. 22) EXCHANGING FUSES AND HALOGEN LAMPS SHOULD BE DONE A FEW MINUTES AFTER THE MAINS SWITCH HAS BEEN TURNED OFF IN ORDER TO ALLOW TIME FOR COOLING. 23) REPLACE FUSE AS MARKED. 24) NEVER LIFT OR MOVE FOOTSWITCH BY THE CABLE. DAMAGE MAY RESULT. Pag. 6 of 62

25) THE PRESURGICAL SET-UP AND OPERATION PROCEDURES OUTLINED HEREIN SHOULD BE PERFORMED BEFORE EACH SURGICAL PROCEDURE. IF THE SYSTEM IS NOT OPERATING PROPERLY AND THE TROUBLE-SHOOTING SECTION DOES NOT PROVIDE A SATISFACTORY SOLUTION TO THE PROBLEM, DO NOT USE THE SYSTEM. 26) DO NOT ALLOW THE TIP OF THE VITRECTOMY PROBE, DIATHERMY, OR I/A HANDPIECE TO TOUCH METALLIC OBJECTS. 27) DO NOT ATTEMPT TO ALTER THE SHAPE OF ANY PART OF A HANDPIECE. 28) DO NOT ATTEMPT TO SEPARATE THE PLUG FROM THE CABLE. 29) DO NOT SUBJECT THE HANDPIECE TO HOT AIR STERILIZATION OR "CHEMCLAVE". 30) THE RE-USE OF MATERIALS LABELLED AS FOR SINGLE USE MAY BE CAUSE OF MALFUNCTIONS AND/OR INFECTIONS WHICH COULD SEVERELY AFFECT PATIENT’S SAFETY 31) TO AVOID POSSIBLE DAMAGES TO THE CASSETTE, DISENGAGE COMPLETELY THE DUAL PUMP CASSETTE LATCH BY PULLING THE LATCH HANDLE FORWARD WHILE INSTALLING OR REMOVING THE CASSETTE. 32) CORRECT SET-UP OF IRRIGATION AND ASPIRATION LINES IS CRITICAL TO ENSURE PROPER OPERATION OF THE AMO® GEMINITM UNIT. CAREFULLY OBSERVE THE INDICATIONS OF "IRRIGATION/ASPIRATION TUBING SET-UP" PARAGRAPH IN THIS MANUAL. THE FAILURE TO FOLLOW THESE INDICATIONS COULD HAVE SERIOUS CONSEQUENCES. 33) SWITCHING FROM PERISTALTIC MODE TO VENTURI MODE MAY CAUSE ANTERIOR CHAMBER COLLAPSE IF A LOW IMPEDANCE TIP IS USED (I.E. U/S TIP) AND IF THE VACUUM IS SET AT AN HIGH LEVEL. TO ENSURE PATIENT SAFETY, ALWAYS CHECK THAT VACUUM SETTING IS PROPER FOR THE DESIRED TYPE OF PUMP BEFORE RESTARTING ASPIRATION AFTER A PUMP TYPE SWITCH. 34) DO NOT STORE OR USE THE HANDPIECE IF WET OR MOIST. 35) ALTHOUGH THE FIBER OPTIC ENDO-OCULAR ILLUMINATION SYSTEM IS PROVIDED WITH SAFETY FILTERS TO MINIMIZE EMISSION OF INFRA RED AND ULTRA VIOLET RADIATION, TO AVOID POSSIBLE DAMAGE TO THE RETINA, ALWAYS USE THE MINIMUM LIGHT POWER LEVEL WHICH IS COMPATIBLE TO THE SURGICAL APPLICATION. 36) TO REDUCE THE HAZARD OF RETINAL DAMAGE, DO NOT GO WITH THE EDGE OF THE FIBER OPTIC ILLUMINATION PROBE IN THE IMMEDIATE PROXIMITY OF THE RETINA. 37) DO NOT ACTIVATE THE VITRECTOMY HANDPIECE WITH THE TIP IN AIR. THE TIP SHOULD ALWAYS BE TEST RUN IN A BEAKER OF STERILE SOLUTION. TESTING IN AIR WILL CAUSE IRREPARABLE DAMAGE TO THE TIP. 38) HANDPIECES AND OTHER NON DISPOSABLE ACCESSORIES ARE SUPPLIED NON STERILE. THEY MUST BE FIRST CLEANED, THEN STERILIZED IN AUTOCLAVE AS INDICATED ON THE RELATIVE INSTRUCTIONS. THEY COULD BE DAMAGED BY THE USE OF OTHER STERILIZATION METHODS, LIKE HOT AIR OR "CHEMCLAVE" STERILIZATION.

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39) THE USE OF INFLAMMABLE ANAESTHETICS, ( N20 ), ( 02 ), SHOULD BE AVOIDED UNLESS THEY ARE REMOVED BY A GAS ASPIRATION SYSTEM. 40) DO NOT ACTIVATE THE PHACO U/S HANDPIECE WITH THE PHACO TIP IN AIR. THE ULTRASONIC POWER SHOULD BE APPLIED TO THE PHACO HANDPIECE WITH THE PHACO TIP IMMERSED IN A TEST CHAMBER FILLED WITH INFUSION FLUID OR IN A BEAKER OF STERILE FLUID AT AMBIENT TEMPERATURE. OTHERWISE HANDPIECE DAMAGE MAY RESULT. 41) DO NOT CHECK VIBRATION BY PLACING HAND OR FINGER AGAINST HANDPIECE TIP. PROLONGED EXPOSURE TO OR DIRECT CONTACT WITH THE VIBRATING TIP MAY CAUSE DAMAGE TO HEALTHY TISSUE. 42) ALWAYS USE THE LOWEST ULTRASONIC OUTPUT COMPATIBLE TO THE SURGICAL APPLICATION.

POWER LEVEL WHICH IS ®

TM

43) THE PHACO HANDPIECE MUST BE CONNECTED TO THE AMO GEMINI ASPIRATION SYSTEM AND MUST NOT BE USED WITHOUT IT.

IRRIGATION-

44) AN EXTERNAL STERILIZING FILTER MUST BE INSERTED TO THE AIR SOCKET TO PREVENT INFECTIONS. THE FILTER IS INTENDED FOR SINGLE USE AND MUST BE REPLACED AT ANY NEW SURGERY. 45) THE USE OF NON STANDARD AIR SUPPLY TUBING KIT, MAY COMPROMISE THE ACCURACY OF INTRAOCULAR AIR PRESSURE. 46) DURING SILICONE OIL INJECTION, THE INTRA-OCULAR PRESSURE IS NOT CONTROLLED BY THE AMO® GEMINITM UNIT. THEREFORE, THIS IOP CONTROL IS UNDER THE SURGEON’S RESPONSIBILITY. IT' S IMPORTANT TO CHECK SILICONE FLOW (CORRESPONDING TO THE PRESET INJECTION PRESSURE) BEFORE INSERTING THE CANNULA IN THE EYE. FOR A BETTER FLOW CONTROL DO USE 1000 CS SILICONE OIL. 47) TO STOP SILICONE OIL INJECTION RELEASE THE FOOTSWITCH. IN CASE OF EMERGENCY CONDITIONS CLOSE THE INJECTION STOPCOCK OR DETACH THE SILICONE INFUSION LINE FROM THE SILICONE DELIVERY DEVICE. 48) BEFORE USING A SURGICAL OR NON SURGICAL ACCESSORY IN CONNECTION WITH AMO® GEMINITM, VERIFY THE COMPATIBILITY OF THE SAME WITH AMO® GEMINITM EQUIPMENT. COMPATIBILITY IS STATED ON THE ACCESSORY ACCOMPANYING DOCUMENT. 49) DISPOSE WASTE COLLECTION FLUIDS ACCORDING TO THE LOCAL LAWS/REGULATIONS ON DISPOSAL OF ORGANIC MATERIALS. 50) WHEN AIR INJECTION IS ACTIVE, AN INTERMITTENT BEEP (0.9 SEC PERIOD) IS GENERATED BY THE EQUIPMENT AS A WARNING SIGNAL. 51) SOUND EMISSION CAPABILITY OF THE EQUIPMENT IS TESTED AT POWER-ON. VERIFY THAT AN AUDIBLE BEEP IS EMITTED DURING SYSTEM BOOT. 52) A ROTATING LOGO, PLACED AT THE LOWER SIDE OF THE USER INTERFACE SCREEN, SHOWS THAT THE SYSTEM IS RUNNING PROPERLY. IF SUCH SYMBOL STOPS MOVING IT MEANS THAT THE SYSTEM IS IDLE AND EQUIPMENT OPERATION MUST BE STOPPED. 53) THE SILICONE INJECTION STOP VALVE IS TESTED AT POWER ON. VERIFY THAT NO GAS LEAKAGE IS AUDIBLE DURING SYSTEM BOOT.

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4. SYMBOLS ON MARKING Table shown below reports some symbols approved by I.E.C. and their meaning. When there is not enough room, they are frequently used on medical instruments to enable an easy and fast communication of information and warnings. Sometimes two or more symbols may be assembled to obtain a special meaning. ® TM These symbols are used in the AMO GEMINI tag. Before starting to use the unit, you should familiarize yourself with them and their definitions shown in the table. SYMBOLS PUBLISHED BY THE IEC SYMBOL

DESCRIPTION ALTERNATING CURRENT

DIRECT CURRENT

PROTECTIVE EARTH (GROUND) ATTENTION, CONSULT ACCOMPANYING DOCUMENTS OFF (POWER: CONNECTION FROM THE MAINS) ON (POWER: CONNECTION TO THE MAINS) TYPE B

TYPE BF

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5. GENERAL INFORMATION 5.1

INTRODUCTION

OPTIKON S.p.A. electro-medical product line has earned an international reputation for being technically sophisticated, while remaining highly reliable and easy-to-use. Our "Research and Development" department prides itself on being able to produce innovative products to meet demanding needs of the hospitals, clinics, and surgeons. One of the factors that enable OPTIKON to produce such reliable products is our manufacturing and quality assurance programs. OPTIKON precision products are meticulously manufactured in our own facilities by highly skilled technicians. We utilize special production processes that optimize the reliability of our equipment. And we undertake life cycle testing of every piece of OPTIKON equipment prior to shipping. The result is equipment that is rarely returned for repair, and which we back with a comprehensive one-year warranty. This installation and operating manual is designed to give all needed information and instructions ® TM required for successful operation of your AMO GEMINI surgery system. Please read through these Installation and Operating Instructions carefully and then you ® TM will know how to operate your AMO GEMINI surgery system properly. After you have finished reading this instruction manual, put it away in a safe place for future reference. A handy indexing system at the beginning of this manual gives you quick and direct access to desired paragraphs. Included in the last pages of this manual are engineering illustrations and other reference ® TM information useful to the user of the AMO GEMINI surgery system. COMPANY PROFILE OPTIKON S.p.A. is proud to continue the work that OPTIKON OFTALMOLOGIA began in 1966 by putting themselves at the forefront of innovation, in the ophthalmic surgery and diagnostic instrumentation field. We are recognized by the most demanding hospitals, clinics and surgeons as being a cut above the rest of the industry. This kind of widespread acceptance didn' t just happen. It' s the result of nearly three decades of inventive engineering, manufacturing expertise, uncompromising quality control procedures and dedicated management. Today, OPTIKON pioneering research has produced state-of-the-art products that address almost every conceivable application of ocular surgery and diagnostics. We constantly strive to maintain our position as the market leader in ocular surgery and allied systems. Understanding our customer' s ophthalmic needs is important, however more important is our ability and commitment to convert that understanding to practical results.

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WORKING WITH YOU OPTIKON S.p.A. is geared for customer support. We strive to develop a close working relationship with our customers and if we cannot meet your requirements with a standard product, we will be pleased to develop a customized design specifically suited to your application. Whether your needs are straightforward or complex, we will find the appropriate solution for your application.

OPTIONS AND ACCESSORIES ®

TM

The AMO GEMINI unit can be equipped with a number of options to enhance its versatility. For information regarding options and accessories Contact AMO and ask for an accessories list catalogue or visit our website.

Q.C./TESTING OPTIKON maintains an ISO9001 fully approved instrument test department capable of testing to all electrical and mechanical requirements. Life cycle testing of production devices is conducted on a continuing basis, monitoring overall quality of the end product. Each equipment is fully tested and burned-in to ensure that it meets or exceeds all performance requirements.

HOW TO ORDER Every AMO product is available through a worldwide network of authorized distributors. Whether you have a technical question, desire a product demonstration, or require after sales service, every distributor has been trained to serve your needs. Please, contact the AMO representative in your area.

DESIGN AND SPECIFICATIONS Due to improvements in design and/or specifications, some products may differ slightly from the instruction manual representation/description.

IMPORTANT a) CUSTOM OPTION AND VARIETY OF ACCESSORIES PERMIT ® TM TAILORING AMO GEMINI TO YOUR SPECIFIC NEEDS. b) OPTIKON S.p.A. IS AN ISO9001 CERTIFIED COMPANY, THE AMO TM GEMINI SYSTEM IS MANUFACTURED TO SATISFY THE STRINGENT REQUIREMENTS OF CE 9342 DIRECTIVE BOTH IN CONTROL SYSTEM DESIGN AND ALL COMPONENTS OF BASIC PACKAGE AND MICROSURGICAL ACCESSORIES.

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®

5.2

SYSTEM DESCRIPTION ®

TM

AMO GEMINI is an advanced microprocessor based unit for anterior and posterior segment surgical procedures. Reliability, versatility, mobility and adaptability combined with sound engineering design, make the AMO® GEMINITM unique among similar devices currently available on the world market. It is designed to perform irrigation, irrigation/aspiration, phacoemulsification, anterior and posterior vitrectomy, tamponade (silicone and air), bipolar diathermy coagulation procedures and intraocular illumination. AMO® GEMINITM operates with time saving simplicity and is extremely easy to use thanks to the LCD (liquid Crystal Display) touch-screen user interface. It can be operated with factory set parameters, or user defined set up parameters (user programs). All functions and operational parameters are independently set up by pressing the appropriate “soft” keys on the touch-screen. A complete system of visual and audible signals aids in set up, indicates operating mode and situations requiring attention to ensure patient safety. Once the selected function has been set up, it may be executed in real-time by simply depressing the footswitch. The aspiration is equipped with an unique dual pump system in a single disposable cassette: the Surgeon can switch between Venturi and peristaltic pump during surgery. The anticollapse system eliminates pulsation and increases fluid suction precision. Vacuum is programmable from 5 to 500 mmHg, step 5 mmHg. Irrigation flow and Intra Ocular Pressure are regulated by the height of the irrigation source. Gravity fed reflux from BSS irrigation source provides reverse flow in a perfectly sterile environment. Versatility is assured by the wide range of available accessories, which provide the surgeon with the facility to undertake most ophthalmic procedures. All microsurgical handpieces are ergonomically designed for comfort in use and maximum manual dexterity. Clear audio/visual alerts aid in set up and indicate situations requiring attention thus ensuring patient safety. ®

TM

The AMO GEMINI unit is optimally safeguarded and built according to the latest INTERNATIONAL SECURITY STANDARDS. All possible safeguards are built-in so that the instrument will not react on inappropriate manipulations. IMPORTANT a) CUSTOM OPTION AND VARIETY OF ACCESSORIES PERMIT ® TM TAILORING "AMO GEMINI " TO YOUR SPECIFIC NEEDS. b) OPTIKON S.p.A. IS AN ISO9001 CERTIFIED COMPANY, THE AMO® GEMINITM SYSTEM IS MANUFACTURED TO SATISFY THE STRINGENT REQUIREMENTS OF CE 93/42 EEC DIRECTIVE BOTH IN CONTROL SYSTEM DESIGN AND ALL MICROSURGICAL ACCESSORIES.

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5.3

TECHNICAL SPECIFICATIONS

PARAMETER

SPECIFICATION

MANUFACTURER: ...

OPTIKON 2000 S.p.A. VIA DEL CASALE DI SETTEBAGNI, 13 00138 ROMA ITALY

MODEL: ...

AMO® GEMINITM

CLASSIFICATION (IEC 601-1): ...

CLASS I

CLASSIFICATION (UL 544): ...

PATIENT CARE EQUIPMENT

ENVIRONMENTAL SPECS: STORAGE ... OPERATION ...

temp range –10°C to +70°C, humidity 10-100% (non condensing) temp range +10°C to +40°C, humidity 30-75%.

ELECTRICAL SPECS: INPUT VOLTAGE: ...

100-120-220-230-240 VOLT A.C. SELECT.

FREQUENCY: ... ..

50/60 Hz

POWER CONSUMPTION: ...

260 WATTS

LINE FUSES: ...

220/240 VOLT: 2.5 A T 100/120 VOLT: 5 A T

COMPRESSED AIR SPECS: INPUT AIR PRESSURE: ...

from 5 to 8 bars

AIR CONSUMPTION: ...

30 Normal litre/minute

IRRIGATION: FLUID DELIVERY: ...

Gravity fed. Eye pressure determined by the height of irrigation source.

VALVING ELEMENT: ...

Solenoid driven valve

CONTROL: ...

System footswitch

ASPIRATION ASPIRATION PUMP TYPES: ...

Venturi and peristaltic

ACTUATING MEDIUM: ...

Pressurized air from external source. Pressure: 5÷8 bars. Flow: at least 30 Normal litre/minute @ 500mmHg.

DEFAULT VACUUM LEVEL: ...

User programmable

AVAILABLE VACUUM RANGE: ...

5 to 500 mmHg

DEFAULT FLOW RATE: ...

User programmable

AVAILABLE FLOW RATE RANGE: ...

2 to 50cc/min (peristaltic only)

AVAILABLE ASPIRATION RISE TIME: ...

Three levels, SLOW, MED, FAST

SURGEON MODE (Linear ASPIRATION): ...

Linear aspiration (Vacuum and/or flow rate) from zero to preset linearly controlled via system footswitch.

Pag. 13 of 62

SAFETY DEVICE: ... CONTROL: ...

Vacuum sensor; monitors the vacuum in the aspiration line. System footswitch

VIT (VITRECTOMY) HANDPIECE TYPE: ...

Pneumatically powered guillotine cutter (VIT), pneumatically powered micro-scissors (SCISS).

CUTTING MODE: ...

Reciprocating motion

DEFAULT CUT RATE: ...

User programmable

AVAILABLE CUTTING RATE: ...

(VIT) From 60 to 2000 cuts per minute, (SCISS) From 60 to 320 cuts per minute

SINGLE CUT: ...

Single cut mode available.

PORT SIZE: ...

0.7mm

ACTUATING MEDIUM: ...

Pressurized air from external source.

OPERATING PRESSURE: ...

2.0 +0/- 0.1 bars (29 +0/-1.5 PSI)

SURGEON MODE (Linear cut): ...

Linear cut rate from 0 to preset controlled via system footswitch

CONTROL: ...

System footswitch

DIATH (DIATHERMY) TYPE: ...

Bipolar generator. Generator stops when RF power is not needed.

OPERATING FREQUENCY: ...

2 MHz

NOMINAL POWER: ...

7W (450 Ohm LOAD)

NO LOAD MAX. VOLTAGE: ...

100 V

DEFAULT BIPOLAR POWER: ...

User programmable

AVAILABLE BIPOLAR POWER: ...

5 to 100% (percent).SURGEON MODE (linear power): Allows linear control of the DIATHERMY power via system footswitch depression.

HANDPIECE TYPE: ...

Bipolar microforceps, slim stat pencil eraser, intraocular diathermy pencils.

DIATHERMY CABLE: ...

two poles, 26 gauges, 75 ohm, steam autoclavable. Use only original OPTIKON diathermy cable.

CONTROL: ...

System footswitch

ILLUM (ILLUMINATION) SOURCE TYPE: ...

Halogen lamp

POWER: ...

150 watt

INTENSITY ADJUSTMENT: ...

Mechanical diaphragm, four levels + green filter

AIR INJECTION SECTION : NOMINAL PRESSURE: ...

from 5 to 80 mm/Hg

Pag. 14 of 62

ACTUAL IOP: ...

Nominal pressure +/- 3 mm/Hg

SAFETY DEVICES: ...

Air activation sound

SILICONE INJECTION SECTION : NOMINAL PRESSURE: ...

from 0.4 to 5 bars

SIGNALS: ...

Silicone injection activation sound, Low pressure at air inlet

PHACOEMULSIFIER HANDPIECE TYPE: ...

Piezoelectric

FREQUENCY: ...

approx. 40KHz

TIP STROKE: ...

from 0 to 100µm

POWER: ...

Panel or linear control of the U/S power via system footswitch depression.

U/S MODE: ...

Linear or panel; Continuous, Short Pulse, Single Burst, Multi-Burst, Continuous Burst

U/S TIMER: ...

From 0.00 minutes to 9.59 minutes – Equivalent Phaco Time display

COMPLIANCE TO STANDARD FOR SAFETY

INSTRUMENT CLASSIFICATION ACCORDING TO I.E.C. 601-1

TYPE OF PROTECTION AGAINST ELECTRIC SHOCK: ... CLASS 1 equipment DEGREE OF PROTECTION AGAINST ELECTRIC SHOCK: -DIATHERMY: ... -U/S: ... -AIR and SILICONE: ...

TYPE BF, floating both at high and low frequencies TYPE B TYPE BF

DEGREE OF PROTECTION AGAINST HARMFUL INGRESS OF WATER: ...

ORDINARY equipment

DEGREE OF SAFETY OF APPLICATION IN THE PRESENCE OF A FLAMMABLE ANAESTHETIC MIXTURE: ...

NOT SUITABLE

MODE OF OPERATION: -DIATHERMY: ...

INTERMITTENT OPERATION 60sec / 120sec

UL 544 INSTRUMENT CLASSIFICATION: ... -DIATHERMY: ...

Patient Care Equipment Isolated connection, floating both at high and low frequencies.

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IMPORTANT NOTICE: 1) ALL REUSABLE HANDPIECES AND MICROSURGICAL ACCESSORIES ARE AUTOCLAVABLE (REFER TO ACCESSORIES ACCOMPANYING INSTRUCTION SHEET). 2) THE FOOTSWITCH AND THE DISPOSABLE ITEMS ARE NOT AUTOCLAVABLE. 3) "CHEMCLAVE" AND HOT AIR STERILIZATION MUST BE AVOIDED TO PREVENT IRREPARABLE DAMAGE TO THE HANDPIECE. 4) ALL DEFAULT PARAMETERS ARE INDEPENDENTLY ADJUSTABLE TO MEET INDIVIDUAL REQUIREMENTS, THEY CAN BE PROGRAMMED BY THE USER IN THE SYSTEM MEMORY, UP TO 1000 PROGRAMS CAN BE STORED, THEY ARE RETAINED FOR APPROXIMATELY TEN YEARS.

DIMENSIONS HEIGHT: ...

26 cm (10.2 inches)

WIDTH: ...

36.5 cm (14.4 inches)

DEPTH: ...

41.5 cm (16.3 inches)

WEIGHT: ...

28 Kg (62 lbs)

NOTE:

1) Weight and dimensions shown are approximate. 2) Specifications are subject to change without notice.

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5.4

CLEANING AND STERILIZATION

For cleaning, decontamination and sterilization of the reusable surgical instruments of the AMO® GEMINITM system, refer to the relevant instructions for use. The console, the footswitch and the cart with electric pole cannot be sterilized, they can be cleaned according to the indications given in the “MAINTENANCE AND CARE" paragraph.

THE FOLLOWING POINTS MUST BE OBSERVED: A) DO NOT REUSE MICROSURGICAL INSTRUMENTS WHICH ARE LABELLED FOR SINGLE USE. B) DO NOT SUBJECT ANY OF THE MICROSURGICAL INSTRUMENTS TO "CHEMCLAVE" OR TO HOT AIR STERILIZATION. C) CONTAMINATED REUSABLE MICROSURGICAL INSTRUMENTS MUST BE THOROUGHLY CLEANSED BEFORE THE STEAM STERILIZATION. WHEN PROCEEDING OTHERWISE, RESIDUES CAN BAKE DURING STEAM STERILIZATION PROVIDING A PROTECTIVE LAYER PREVENTING MICRO ORGANISMS BEING DESTROYED EFFECTIVELY. FURTHERMORE, ANY ADHERING CONTAMINANTS MIGHT DAMAGE PLASTIC ITEMS IN PARTICULAR, DUE TO THE HIGH TEMPERATURES. D) FOR FURTHER INFORMATION REGARDING CLEANING PLEASE SEE PARAGRAPH "MAINTENANCE AND CARE".

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6. INSTALLATION AND MAINTENANCE 6.1

INTRODUCTION

This section details a recommended installation and operational checkout procedure for the AMO® TM GEMINI surgery system. The operational checks, however, which are performed after the system installation to verify instrument operation, must be performed exactly as indicated and should not be regarded as recommended practice or as encouragement for surgical operating room procedures. ®

TM

To bring your AMO GEMINI surgery system in operation, a series of cable and tubing connections for control console, footswitch, handpieces and I/A system must be made. Follow the installation and operating instructions carefully in a step by step manner and, within a ® short time, you will have gained all the knowledge needed for successful operation of your AMO TM GEMINI surgery system.

IMPORTANT NOTICE:

INCLUDED IN THE LAST PAGES OF THIS MANUAL ARE ENGINEERING ILLUSTRATIONS AND OTHER REFERENCE INFORMATION USEFUL TO THE USER OF "AMO® GEMINITM" SURGERY SYSTEM. EVERY EFFORT HAS BEEN MADE TO HAVE ALL THE ILLUSTRATIONS AND INFORMATION ACCURATELY REPRESENT THE PRODUCT AND ITS OPERATION AS IT ACTUALLY WAS AT THE TIME THIS OPERATION MANUAL WAS PRINTED. OBVIOUSLY, HOWEVER, SO THAT WE MAY EFFECTIVELY CONTINUE TO MEET THE REQUIREMENTS OF USERS, CHANGES IN SOME ITEMS MAY BE MADE DURING THE LIFE OF THIS MANUAL, WHICH, ON OCCASION, MAY BE MADE WITHOUT NOTICE.

6.2

INITIAL INSPECTION

This instrument was carefully inspected, mechanically and electrically, prior to shipment. ®

TM

Before unpacking the AMO GEMINI surgery system, inspect the carton for damage. If it is damaged, be especially careful when inspecting the contents for any mechanical damage which may have occurred during shipment, and test the electrical performance. If physical damage is found, you should apply at once to the carrier that handled the consignment (mail, railways or forwarding agents) and have an appropriate certificate established. Without documentary evidence, claim cannot be filed.

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6.3

INSTALLATION

The following procedure should be observed to install the system: 1) Unpack the equipment and its accessories. ®

2) Place the AMO GEMINI

TM

unit on a secure surface.

3) Unwrap the handpieces and microsurgical instruments, place them in a secure location to prevent accidental dropping.

NOTE:

IT IS THE RESPONSIBILITY OF THE USER TO CLEAN AND STERILIZE THE HANDPIECES, TIPS, I/A TUBINGS AND OTHER MICROSURGICAL REUSABLE INSTRUMENTS.

4) Connect the "GAS FILTER" supplied with the unit (Fig.3, No.4) to the rear panel. 5) Connect the tube supplied with the unit between "FILTER OUTLET" (Fig.3, No.5) and "AIR INPUT" (Fig.3, No.10). 6) Check that the pressure level of the compressed air supply corresponds to the value indicated on the rear panel (from 5 to 8 bars). 8) Using the tube for compressed air supply (122001) connect the "GAS INLET" (Fig.3, No.3) input of the gas filter to the compressed air supply line. 9) Connect the linear footswitch cable (Fig.4A and 4B) to the "FOOTSWITCH CONTROL" socket (Fig.3, No.9). Turn the retaining ring clockwise to secure the plug. 10) If the OPTIKON AUTOMATIC I.V. POLE is available, connect it to the I.V. POLE connector (Fig.3, No.12). 11) Check that the available A.C. supply voltage corresponds to the one selected on the rear panel. 12) Connect the A.C. power cord to the A.C. power input (Fig.3, No.8) and then plug it into an earthed (grounded) electricity wall outlet. Do not turn power on. NOTE: ® TM THE AMO GEMINI TESTS IF THE AUTOMATIC I.V. POLE IS PRESENT WHEN THE UNIT IS SWITCHED ON; THEREFORE BE SURE THAT THE POLE IS CONNECTED AND POWERED.

CAUTION:

®

TM

IT IS IMPORTANT THAT THE AMO GEMINI " SURGERY SYSTEM BE OPERATED WITHIN THE SPECIFICATIONS STATED IN THIS MANUAL. ALL THE APPLICABLE ELECTRICAL, MECHANICAL AND OTHER WARNINGS SHOULD BE ADHERED TO IN THE OPERATION OF "AMO® GEMINITM". FAILURE TO OBSERVE EITHER OF THE AFOREMENTIONED MAY CREATE A HAZARDOUS CONDITION OR CAN ADVERSELY AFFECT THE PROPER SYSTEM OPERATION.

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