Operators Manual
133 Pages
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Page 1
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Please consult with Alcon Technical Support for information on the most recent revision release Operators Manual for this product.
SERIES 20000 ™* LEGACY ® EVEREST ™ SYSTEM CAVITRON®/ KELMAN® • PHACO - EMULSIFIER® ASPIRATOR
Operator's Manual
Manufacturer: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 U.S.A.
Produced By: Alcon Laboratories, Inc. 15800 Alton Parkway Irvine, California 92618-3818 U.S.A. Telephone: FAX:
EU Authorized Representative: Alcon Laboratories (U.K.) Ltd. Boundary Way, Hemel Hempstead Hertfordshire, HP2 7UD England
0123
Directive 93/42/EEC
949/753-1393 800/832-7827 949/753-6614
8065750595 AE, CAT / REF / PART NO. 905-2030-010 B, TEXT ONLY
© 1993-2005 Alcon, Inc.
Legacy ® Everest ™ System
SERIES 20000™* LEGACY® EVEREST™ SYSTEM Operator's Manual 8065750595 MANUAL REVISION RECORD
DATE
REVISION
ECN NUMBER AND DESCRIPTION
May 2005
AD
Initial release of operator's manual with 905-2030-010 text (software version 3.25).
May 2005
AE
20050555 - Add new coagulation function data. i, ii, iii, v, vi, 1.12, 1.18, 4.4, 7.1 thru 7.4. Pages 1.12 thru 1.18 expanded from 1.12 thru 1.20.
* Registered in the U.S. Patent & Trademark Office. ** Mackool is a trademark of Richard J. Mackool, M.D. SmartPhaco is a trademark of MicroMedical Devices, Inc. Instruzyme is a trademark of Peters S.A. ii
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Legacy ® Everest ™ System
TABLE OF CONTENTS
SECTION ONE - GENERAL INFORMATION
PAGE #
Introduction... 1.1 General Information... 1.2 Abbreviation Descriptions... 1.3 Accessory Equipment... 1.3 Environmental Issues... 1.3 Universal Precautions... 1.3 EMC Statement... 1.4 Cautions and Warnings... 1.7 Cautery, Diathermy, Coagulation... 1.15 Product Service... 1.15 Limited Warranty... 1.16 SECTION TWO - DESCRIPTION
PAGE #
Electronic System... 2.1 System Design... 2.2 Front Panel... 2.2 Cassette Housing... 2.7 Connector Panel... 2.7 Rear Panel... 2.8 Other Features... 2.10 Audible Tones... 2.10 Remote Control... 2.11 Modes and Functions... 2.13 Irrigation (Irr) Mode... 2.15 AdvanTec™* Mode... 2.17 Ultrasound (U/S) Mode... 2.22 Irrigation/Aspiration (I/A) Mode... 2.26 Vitrectomy (Vit) Mode... 2.28 Coagulation (Coag) Mode... 2.29 Custom Mode... 2.31 Custom - Program Mode... 2.34 Custom - Sound Mode... 2.41 Custom - Voice Mode... 2.42 Custom - Language Mode... 2.42 Custom - Footswitch Mode... 2.42 Custom - Remote Mode... 2.44 Test Mode... 2.45 Footswitch... 2.47
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Legacy ® Everest ™ System
SECTION TWO - DESCRIPTION
PAGE #
Handpiece and Tip Descriptions... 2.50 Ultraflow™* Irrigation and I/A Handpieces and Tips... 2.50 Reusable I/A Tips... 2.52 Ultrasonic Handpieces... 2.53 ATIOP Handpiece... 2.55 Coagulation Handpieces... 2.56 Kelman® Steerable I/A Handpiece... 2.57 Kelman® Steerable I/A Tip... 2.57 Consumable Pak Configurations... 2.58 TurboSonics® Family of Tips... 2.58 Infusion Sleeves... 2.60 Standard Series Cassette... 2.60 MaxVac® Series Cassette... 2.60 Series 20000™* Legacy® TurboSonics® Family of Paks... 2.61 Remote Control Aseptic Transfer (RCAT) Packaging... 2.61 Error Processing... 2.62 SECTION THREE - OPERATING INSTRUCTIONS
PAGE #
Introduction... 3.1 Power Up Sequence... 3.1 Standard Phacoemulsification Setup Procedure... 3.2 System Fluidics Test... 3.5 Irrigation/Aspiration Handpiece Setup... 3.6 Kelman® Steerable I/A Handpiece and Tip Setup... 3.8 NeoSoniX®, 375/40 U/S, or Mackool** Handpiece Setup... 3.10 Anterior Vitrectomy Setup Procedure... 3.14 Primary Anterior Vitrectomy Setup Procedure... 3.15 SECTION FOUR - CARE AND MAINTENANCE
PAGE #
Immediately After Each Surgical Procedure... 4.1 Upon Completion of the Day's Surgery Schedule, Clean Externally... 4.4 Periodic Fan Filter Cleaning Procedure... 4.4 Sterilization Instructions... 4.5 Fuse Replacement... 4.6 SECTION FIVE - TROUBLESHOOTING
PAGE #
Introduction... 5.1 Legacy® System Troubleshooting Instructions... 5.2 SECTION SIX - ACCESSORIES AND PARTS
PAGE #
Items and Catalog Numbers... 6.1 SECTION SEVEN - INDEX
PAGE #
Alphabetical Listing of Topics... 7.1
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LIST OF FIGURES FIGURE#
TITLE
PAGE #
Figure 1-1 Figure 1-2 Figure 1-3 Figure 1-4 Figure 1-5 Figure 1-6
The Legacy® Everest™ System... 1.1 Icons Used with the Legacy® Everest™ System... 1.18 Labeling Used on the Legacy® Everest™ System... 1.19 Coagulation Power Through 75 Ohm Load... 1.20 Coagulation Power vs. Load Impedance... 1.20 Coagulation Output Peak Voltage vs. Output Control Setting... 1.20
Figure 2-1 Figure 2-2 Figure 2-3 Figure 2-4 Figure 2-5 Figure 2-6 Figure 2-7 Figure 2-8 Figure 2-9 Figure 2-10 Figure 2-11 Figure 2-12 Figure 2-13 Figure 2-14 Figure 2-15 Figure 2-16 Figure 2-17 Figure 2-18 Figure 2-19 Figure 2-20 Figure 2-21 Figure 2-22 Figure 2-23 Figure 2-24 Figure 2-25 Figure 2-26 Figure 2-27 Figure 2-28 Figure 2-29 Figure 2-30 Figure 2-31 Figure 2-32 Figure 2-33 Figure 2-34 Figure 2-35 Figure 2-36 Figure 2-37 Figure 2-38 Figure 2-39 Figure 2-40
Front Control Panel... 2.2 Graphics Display and Touch Screen... 2.4 Cassette Housing and Connector Panel... 2.7 Rear Connector Panel... 2.8 Legacy® Everest™ System Rear View... 2.9 Remote Control... 2.11 Remote Control Switches... 2.12 Legacy® Everest™ System Modes and Submodes... 2.13 Irrigation Mode... 2.15 AdvanTec™* Visco Mode... 2.17 Footswitch Functions - AdvanTec™* Mode... 2.18 AdvanTec™* Pulse Mode... 2.20 Footswitch Functions -U/S Mode... 2.22 Footswitch Functions - I/A Mode... 2.26 Footswitch Functions - Vitrectomy Mode... 2.28 Footswitch Functions - Coag Mode... 2.29 Priming is in Progress... 2.30 Custom Mode... 2.31 Custom: Program... 2.32 Metrics Screen... 2.33 Special IV Pole Setup... 2.35 Special Functions: Aspiration... 2.36 Custom: Sound... 2.41 Custom: Footswitch... 2.42 Custom: Footswitch: Procedure... 2.43 Accurus®/Legacy® Footswitch... 2.47 Footpedal Travel by Mode of Operation... 2.48 Ultraflow™* Handpiece and .3 mm Tips... 2.51 Ultraflow™* O-Ring Tool... 2.51 Ultraflow™* SP Handpiece... 2.51 Reusable I/A Tips and Threaded Tip Adaptor... 2.52 375/40 U/S Handpiece with Infusion Sleeve and Bubble Suppression Insert... 2.53 NeoSoniX® Handpiece... 2.54 ATIOP Handpiece... 2.55 4 Inch Nadler Coaptation, 0.4 mm Tip... 2.56 Disposable Bipolar Brush... 2.56 Coagulation Cord... 2.56 Kelman® Steerable I/A Handpiece... 2.57 Kelman® Steerable I/A Tip... 2.57 Mackool** Tips... 2.59
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FIGURE#
TITLE
PAGE #
Figure 2-41 Figure 2-42 Figure 2-43 Figure 2-44 Figure 2-45 Figure 2-46 Figure 2-47
ABS® Tips... 2.59 Standard Series U/S Tips... 2.59 Mackool** Series U/S Tips... 2.59 The Aspiration Bypass System... 2.59 Kelman® High Efficiency Tips... 2.59 Epsilon™* TurboSonics® Tips... 2.59 Flared ABS® Tips... 2.59
Figure 3-1 Figure 3-2 Figure 3-3 Figure 3-4 Figure 3-5 Figure 3-6 Figure 3-7 Figure 3-8 Figure 3-9 Figure 3-10 Figure 3-11 Figure 3-12
Closing of Remote Control Aseptic Transfer Package... 3.3 Drape Pushed Down Through Open Wire Loop to Form Pouch... 3.3 Tubing Orientation... 3.4 Cassette Installation... 3.4 Squeeze Drip Chamber to Introduce BSS® Fluid Into Bottle... 3.4 Attaching Infusion Sleeve... 3.6 Cap Removal... 3.10 U/S Tip/Wrench Assembly... 3.10 Mackool** Tips... 3.11 Preparing the Test Chamber... 3.12 Place Handpiece Vertically in Pouch Formed with Drape... 3.12 Footswitch Functions - ATIOP... 3.14
Figure 5-1
Legacy® Troubleshooting Guide... 5.1
TABLE#
TITLE
Table 1-1 Table 1-2 Table 1-3 Table 1-4 Table 1-5 Table 1-6 Table 1-7
Guidance and Manufacturer's Declaration - Electromagnetic Emissions... 1.4 Guidance and Manufacturer's Declaration - Electromagnetic Immunity... 1.5 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Infiniti™* Vision System... 1.6 Recommended Vacuum Range for Various I/A Tips... 1.9 Occlusion Tones and Functions... 1.10 Specifications... 1.17 Abbreviations Used with the Legacy® Everest™ System... 1.17
Table 2-1 Table 2-2 Table 2-3 Table 2-4 Table 2-5 Table 2-6 Table 2-7 Table 2-8 Table 2-9
Audible Tones... 2.10 Preset (Default) Values for Selectable Modes & Functions... 2.14 Vacuum Limits and Aspiration Rates... 2.14 PPS and % On Time... 2.20 PPS and % On Time... 2.23 Various Memory Settings... 2.34 Footpedal Travel in Enhanced Modes... 2.44 Heel Switch Duration Table... 2.48 Operation by Mode and Footpedal Position... 2.49
Table 4-1
Sterilization Temperature and Time Settings... 4.5
Table 5-1
Legacy® System Problem Conditions... 5.2
LIST OF TABLES
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PAGE #
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Legacy ® Everest ™ System
PREFACE This operator's manual is your written guide to the Series 20000™* Legacy® (STTL) Everest™ ophthalmic surgical 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. This operator's manual covers the CE certified Legacy® Everest™ System (part number 203-0000-503, and any STTL upgraded to an Everest™ System). The Series 20000™* Legacy® Everest™ System will be referred to as the Legacy® Everest™ System throughout this manual. 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 pak 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 LABORATORIES 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. END USER LICENSE AGREEMENT: This product contains software licensed from Microsoft Corporation.
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viii
LAST PAGE OF THIS SECTION
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SECTION ONE GENERAL INFORMATION Introduction Alcon’s Legacy® Everest™ System is manufactured to be durable, reliable, safe and easy to operate. This state-of-the-art instrument has been developed to be user friendly, combining hardware that is easy to install and maintain along with computer software that increases the effectivity of the user.
Figure 1-1
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THE LEGACY® EVEREST™ SYSTEM
1.1
Legacy ® Everest ™ System
General Information The Legacy® Everest™ System is designed for use in anterior segment procedures that require simultaneous lens fragmentation, irrigation, and aspiration, as well as associated procedures such as vitrectomy and coagulation. It was developed with a dual purpose: to make it simple to operate, and to allow the surgeon tremendous control and flexibility. Following are key features of the Legacy® Everest™ System: • • • • • • • • •
•
• • • • • • • • • • • • •
1.2
Fully programmable, multi-microprocessor control. Advanced fluidics with quick, smooth control and safety of peristaltic aspiration. Modularized fluidic connections in the form of a disposable cassette. High-performance 375/40 U/S phaco handpiece: 40 kHz, piezoelectric, slim, lightweight, autoclavable. NeoSoniX® handpiece combining the features of a phaco handpiece with mechanical oscillations. Ability to drive a steerable irrigation/aspiration tip. Automated IV pole, controlled via the front panel, footswitch, or remote control. Linear footswitch control of ultrasonic power in U/S and AdvanTec™* modes (sophisticated control loop offers low-end control). Several modalities of ultrasonic power control including continuous, pulsed, and "burst" application of ultrasonic power, as well as automatic power reduction during low flow conditions. Linear footswitch control of aspiration flow rate (AFR) or vacuum limit in I/A, VIT, and U/S BiModal modes. Linear footswitch control of AFR whenever Linear Flow control is enabled in the AdvanTec™* mode. Ability to set vacuum levels and aspiration flow rates in U/S, I/A, and VIT modes to desired levels. Ability to switch between surgical modes using touch screen, remote, or footpedal. Ability to drive a disposable guillotine cutter - Advanced Technology Irrigating Ocutome™* Probe (ATIOP). 4-channel wireless remote control. Voice confirmation during mode changes. Flat screen, active matrix color LCD display with touch screen and tiltable, rotatable screen. Variable tones. Reflux via the footswitch or the reflux bulb on the cassette manifold (if installed). Bipolar coagulation capability. High-tech graphical user interface. On demand continuous irrigation. Coagulation during priming. This product uses SMARTPHACO technology.
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Abbreviation Descriptions Many of the abbreviations used in this manual and on the Legacy® Everest™ System are described in Table 1-4. Icons are identified in Figure 1-2. Accessory Equipment Accessory equipment connected to or used with this equipment must be certified according to the respective IEC Standard (e.g., IEC 60950 for data processing equipment, and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with System Standard IEC 60601-1-1. Anyone connecting additional equipment or otherwise causing a different system configuration than provided by Alcon is responsible for continued compliance to the requirements of System Standard IEC 60601-1-1. If in doubt, consult the Technical Services department or your local Alcon representative. Environmental Issues Follow local governing ordinances and recycling plans regarding disposal or recycling of device components and packaging. Universal Precautions Universal precautions shall be observed by all people who come in contact with the instrument and/or accessories to help prevent their exposure to blood-borne pathogens and/or other potentially infectious materials. In any circumstance, wherein the exact status of blood or body fluids/tissues encountered are unknown, it shall be uniformly considered potentially infectious and handled in accordance with OSHA guidelines.
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Legacy ® Everest ™ System
EMC Statement It is important to install and use the equipment in accordance with the instructions in order to prevent harmful interference with other devices in the vicinity. If this equipment causes harmful interference to other devices (determined by turning the equipment off and on), the user is encouraged to try to correct the interference by one or more of the following measures: • • • • Table 1-1
Reorient or relocate the other device(s). Increase the distance between the equipment. Connect this equipment into an outlet on a circuit different from that to which the other device(s) is connected. Consult the manufacturer or your Alcon field service engineer for help.
Guidance and Manufacturer's Declaration - Electromagnetic Emissions - The Series 20000™* Legacy® Everest™ System is intended for use in the electromagnetic environment specified below. The customer or the user of the Legacy® System should assure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment-Guidance
RF emissions CISPR 11
Group 1
The Legacy® 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.
RF emissions CISPR 11
Class A
Harmonic emissions IEC 61000-3-2
Class A
Based on extensive field experience the Legacy® System is suitable for use in all establishments including domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.
Voltage fluctuations/ Flicker emissions IEC 61000-3-3
Complies
The EMC Statement provides guidance on steps to take in case of electromagnetic interference.
1.4
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Table 1-2 Guidance and Manufacturer's Declaration - Electromagnetic Immunity - The Series 20000™* Legacy® Everest™ System is intended for use in the electromagnetic environment specified below. The customer or the user of the Legacy® System should assure that it is used in such an environment. IEC 60601 Test Level
Compliance Level
Electromagnetic Environment-Guidance
Electrostatic discharge (ESD) IEC 61000-4-2
• ±6 kV contact • ±8 kV air
• ±6 kV contact • ±8 kV air
Floors should be wood, concrete, or ceramic tile. If floors 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 commercial or hospital environment.
Surge IEC 61000-4-5
• ±1 kV differential mode • ±2 kV common mode
At 115 V: Mains power quality should be that of a typical • ±1 kV differential mode commercial or hospital environment. • ±1 kV common mode When powered at 100-120V, to avoid system shut down due to power-line surges consider powering At 230/240 V: • +1 kV differential mode the Legacy® System through branch circuit that has • ±2 kV common mode surge suppressor for protection against lightning surges (e.g. at power panel to surgical/office suite).
Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11
• <5% UT (>95% dip • <5% UT (>95% dip Mains power quality should be that of a typical commercial or hospital environment. If the use of in UT) for 0.5 cycle in UT) for 0.5 cycle • 40% UT (60% dip in • 40% UT (60% dip in the Legacy® System requires continued operation during power mains interruptions, it is recommended UT) for 5 cycles UT) for 5 cycles • 70% (30% dip in UT) • 70% (30% dip in UT) that the Legacy® System be powered from an for 25 cycles for 25 cycles uninterruptible power supply or a battery. • <5% (>95% dip in • <5% (>95% dip in UT) for 5 sec UT) for 5 sec
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8
3 A/m
Immunity Test
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
3 Vrms 150 kHz to 80 MHz
3 V/m 80 MHz to 2.5 GHz
3 A/m
3 Vrms
3V/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Portable and mobile RF communications equipment should be used no closer to any part of the Legacy® System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency to the transmitter. Recommended separation distance: d = 1.2÷P d = 1.2÷P 80 MHz to 800 MHz d = 2.3÷P 800 MHz to 2.5 GHz where P is the maximum output power rating to the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strength from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with following symbol.
UT is the a.c. mains voltage prior to application of the test level. At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To access the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the (equipment or system) is used exceeds the applicable RF compliance level above, the (equipment or system) should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Legacy® Vision System. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Note: Note 1: Note 2: a
b
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Legacy ® Everest ™ System
Table 1-3 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Series 20000™* Legacy® Everest™ System - The Legacy® System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Legacy® System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Legacy ® System as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter (W)
Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.2÷P d = 1.2÷P d = 2.3÷P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rates at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1 - At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2 - These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
1.6
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Cautions and Warnings Most of these warnings are stated elsewhere in this manual; however, for easy reference they are repeated in greater detail here. If additional information is required, please contact your local Alcon service representative, or the Technical Services Department. NOTE: If an inconsistency exists between the instructions in the operator's manual and the Directions For Use (DFU) supplied with a consumable pak or accessory, follow the DFU.
WARNING! Good clinical practice dictates testing for adequate irrigation, aspiration flow, and operation as applicable for each handpiece prior to entering eye.
WARNING! Inadvertent actuation of Test Mode while a handpiece is in the eye can create a hazardous condition that may result in patient injury.
WARNING! If the Legacy® Everest™ System is used at the 240V setting in the United States or Canada, it should be used on a center-tapped, 240V single phase circuit.
WARNING! Keep clear of the IV pole when it is in motion to prevent skin, hair, and/or clothing from being trapped in the IV pole mechanism. The IV pole moves during power on/off, priming, and bottle height adjustment.
WARNING! Use of accessories and cables other than those provided may result in increased emissions or decreased immunity of the system. Portable and mobile RF communications equipment can affect this medical electrical equipment.
Ultrasonic Handpiece Care The 375/40 U/S, the Mackool**, and the NeoSoniX® handpieces are surgical instruments and must be handled with care. Be sure the cord plug is completely dry before connecting it to the console. Immediately following surgery the handpiece must be thoroughly cleaned. DO NOT CLEAN ULTRASONICALLY. Ultrasonic cleaning of these handpieces will cause irreparable damage. For cleaning procedures, see the Disassembly and Cleaning section of this manual. The handpiece tip should not touch any solid object while in operation. The 375/40 U/S, the Mackool**, and the NeoSoniX® handpieces 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.
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Legacy ® Everest ™ System
CAUTION Prior to sterilization, the 375/40 U/S, the Mackool**, and the NeoSoniX® handpieces 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. WARNINGS! Use of the 375/40 U/S, the Mackool**, or the NeoSoniX® handpiece in the absence of irrigation flow and/or in the presence of reduced or lost aspiration flow can cause excessive heating and potential thermal injury to adjacent eye tissues. Verify that the test chamber is filled with BSS® sterile irrigating solution before tuning the phaco handpiece. Tuning the handpiece in presence of air or air bubbles may generate error and/or will result in premature tip failure and breakage. Use of an ultrasonic handpiece other than the 375/40, the Mackool**, or NeoSoniX®, 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 Series 20000™* Legacy® Turbosonics® pak are only to be used on the 375/40 ultrasonic or NeoSoniX® handpieces.
ATIOP Handpiece Do not operate the ATIOP handpiece outside of the eye unless the tip is immersed in sterile fluid. Damage to the handpiece will result immediately. Ultraflow™* (I/A) Handpiece Prior to each procedure inspect the O-ring at the end of the tip section of the Ultraflow™* handpiece. If damaged, replace the O-ring. If in doubt, contact the Alcon Technical Services Department. WARNING! Use of non-Alcon reusable or disposable I/A handpieces that do not meet Alcon specifications, or use of an Alcon handpiece not specified for use with the Legacy® Everest™ System, may result in a fluidic imbalance. This, in turn, may cause a shallowing or collapsing of the anterior chamber.
U/S and AdvanTec™* Modes Appropriate use of Legacy® Everest™ System parameters and accessories is important for successful procedures. Use of low vacuum limits, low flow rates, low bottle heights, high ultrasonic power settings, extended ultrasound usage, ultrasound usage during occlusion conditions (beeping tones), failure to sufficiently aspirate viscoelastic prior to using ultrasound, excessively tight incisions, and combinations of the above actions may result in significant temperature increases at the incision site and inside eye and lead to severe thermal eye tissue damage. WARNING! I/A tips are not to be used in any Series 20000™* Legacy® AdvanTec™* or U/S submodes.
1.8
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Cautions and Warnings U/S and I/A Handpiece Tips Ensure that handpiece tip is fully tightened to the handpiece. If not securely attached, error may be generated and/or inadequate tuning will occur. Ensure that the tip is not too tight so that it can be removed after use. Use of a tool other than tip wrenches supplied by Alcon may cause damage to the tip and/or handpiece. WARNING! Use 0.9 mm Series 20000™* Legacy® Turbosonics® MicroTip™ U/S tips exclusively with purple Series 20000™* Legacy® Turbosonics® MicroTip™ infusion sleeves. Use 1.1 mm U/S tips exclusively with blue Turbosonics® infusion sleeves. Mismatching U/S tips and infusion sleeves may create potentially hazardous fluidic imbalances.
•
The Mackool** tips are designed for use with the gold Mackool** handpiece only. Do not attempt to thread onto a non-Mackool** handpiece. WARNING! Check for the presence and correct position of the polymer tubing on the Mackool** tips. Never attempt to remove the tubing. Use of the Mackool** tips without the polymer tubing may result in a hazardous condition for the patient.
Recommended Vacuum Range for I/A Tips It is important that only the proper size I/A tip be used when operating in the maximum vacuum level. Only the 0.2 mm or 0.3 mm I/A tips should be used with vacuum limits above 100 mmHg (see Table 1-1). I/A Min and I/A Max adjustable vacuum range is 0-500+.
Table 1-4
TIP SIZE
VACUUM RANGE (mmHg)
0.2 mm
0 - 500+
0.3 mm
0 - 500+
0.5 mm
0 - 100
RECOMMENDED VACUUM RANGE FOR VARIOUS I/A TIPS
Aspiration/Vacuum Adjustments Adjusting aspiration rates or vacuum limits above the preset values may result in aspiration levels (volumes) exceeding irrigation inflow. This may cause chamber shallowing or collapse which may result in patient injury.
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Legacy ® Everest ™ System
Occlusion Tones Two different occlusion tones (intermittent beeping tones during occlusion) indicate that the vacuum is near or at the limit, and aspiration flow is reduced or stopped to avoid exceeding the vacuum limit. The first type, the Aspiration Occlusion tone, sounds when occlusion occurs during aspiration only (in the absence of ultrasonic power). The Aspiration Occlusion tone is a lower, intermittent single beep. The second type of occlusion tone, the U/S Occlusion tone, is a higher, intermittent double beep, and sounds when occlusion occurs during application of ultrasonic power. The Aspiration Occlusion and U/S Occlusion tones indicate that the vacuum has reached maximum allowed value. In addition, both sounds can be enabled to indicate that the vacuum is approaching maximum allowed value and that the pump has slowed down. This event is defined as pre-occlusion. Volumes indicating pre-occlusion or occlusion events for both Aspiration and U/S tones can be adjusted individually or turned off (the only exception is that U/S Occlusion tone cannot be turned off). The table below summarizes functions of the occlusion tones. FOOTPEDAL POSITION OCCLUSION TONES
2 (Irrigation and Aspiration)
Aspiration Occlusion Tone
Lower, intermittent single beep. Disabled. Sounds when vacuum has achieved vacuum limit. Indicates that pump has stopped. Volume can be adjusted or turned off, default is on.
3 (Irrigation, Aspiration, Ultrasound, and NeoSoniX® if applicable)
Disabled. Aspiration Pre-Occlusion Tone Lower, intermittent single beep. Sounds when vacuum is approaching vacuum limit (equal approximately 90% of maximum value). Indicates that pump has slowed down. Volume can be adjusted or turned off, default is off. U/S Occlusion Tone
Disabled.
Higher, intermittent double beep. Sounds when vacuum has achieved vacuum limit. Indicates that the pump has stopped, volume can be adjusted but cannot be completely turned off.
U/S Pre-Occlusion Tone
Disabled.
Higher, intermittent double beep. Sounds when vacuum is approaching vacuum limit (equal approximately 90% of the maximum value). Volume can be adjusted or turned off, default is off.
Table 1-5
1.10
OCCLUSION TONES AND FUNCTIONS
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Legacy ® Everest ™ System
Cautions and Warnings Aspiration Flow Rates Actual aspiration flow rates when using small port tips may be less than the flow rate displayed on the front panel. Footswitch Never pick up or move the footswitch by the cable. Damage may result. High Altitudes Vitrectomy cutting performance may vary at high altitudes. Consult Alcon Technical Service for additional information. The Steerable I/A system is limited to use in altitudes under 6,000 feet (1,828 meters). The Steerable I/A system will not perform properly at an altitude over 6,000 feet (1,828 meters). Presurgical Check-out Tests Presurgical check-out tests must be performed as outlined in the Setup and Checkout section. If an error message or advisory message is displayed on the front panel, refer to the Troubleshooting section of this manual. If the problem persists, DO NOT PROCEED. Consumable Paks Do not use consumable paks beyond the expiration date on the outer packaging. Sterile disposable medical devices should not be reused! (Accreditation Manual for Hospitals, 1982). The equipment used in conjunction with the Alcon Series 20000™* Legacy® consumables constitutes a complete system. Use of consumables other than the Alcon Series 20000™* Legacy® consumables may affect system performance and create potential hazards, and if it is determined to have contributed to the malfunction of the equipment under contract, could result in the voidance of the contract and/or invoicing at prevailing hourly rates. In all cases, the instrument setup instructions contained in this manual, and all label instructions in the package, should be thoroughly understood prior to using any of the Series 20000™* Legacy® pak configurations. Ensure that the tubings are not occluded during any phase of operation.
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1.11