OPERATOR'S MANUAL Manufacturer: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 U.S.A. EU Authorized Representative: Alcon Laboratories (U.K.) Ltd. Boundary Way, Hemel Hempstead Hertfordshire, HP2 7UD England Produced By: Alcon Laboratories, Inc. 15800 Alton Parkway Irvine, California 92618-3818 U.S.A. Telephone: FAX: 949/753-1393 800/832-7827 949/753-6614 8065751025 Rev. P3, CATALOG NUMBER 905-2120-001 Rev. P3.1, TEXT ONLY © 2007 Alcon, Inc.
Constellation® Vision System Constellation® Operator's 8065751025 MANUAL REVISION RECORD DATE REVISION 9/15/06 P1 7/2/07 P2 (no PECN) 9/1807 P3 ECN NUMBER AND DESCRIPTION * Registered U.S.
Constellation® Vision System TOPIC TABLE OF CONTENTS PAGE # Manual Revision Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi Important Notice. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
TOPIC TABLE OF CONTENTS Constellation® Vision System PAGE # Fiber Optic Illuminator Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.12 Diathermy Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.12 Pneumatic Handpiece Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.
Constellation® Vision System FIGURE # Figure 1-1 Figure 1-2 Figure 1-3 Figure 1-4 Figure 1-5 Figure 1-6 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 2-9a Figure 2-10 Figure 2-10a Figure 2-10b Figure 2-10c 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 Figur
Constellation® Vision System vi Figure 2-41a Figure 2-42 Figure 2-43 Figure 2-44 Figure 2-45 Figure 2-46 Figure 2-47 Figure 2-48 Figure 2-49 Figure 2-50 Figure 2-51 Figure 2-51a Figure 2-52 Figure 2-53 Figure 2-54 Figure 2-55 Figure 2-56 Figure 2-57 Figure 2-58 Figure 2-59 Figure 2-60 Figure 2-61 Figure 2-62 Figure 2-63 Figure 2-64 Figure 2-65 Figure 2-66 Figure 2-67 Figure 2-68 Figure 2-69 Figure 2-70 Figure 2-71 Figure 2-72 Figure 2-73 Figure 2-74 Figure 2-75 Figure 2-76 Figure 2-77 Figure 2-78 Figure 2
Constellation® Vision System TABLE # Table 1-1 Table 1-2 Table 1-3 Table 1-4 Table 2-1. Table 6-1. 8065751025 TITLE LIST OF TABLES PAGE # Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.2 Terms and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.4 Guidance and Manufacturer's Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Constellation® Vision System FOREWORD This Operator's Manual is designed to acquaint the operator and operating room personnel with the Constellation® Vision System. The manual presents an organized summary of the operating principles, main components, safety features, and instructions for care and use of the instrument. The information in this manual should be supplemented with reference works on laser theory and the interaction of laser energy with biologic tissues.
Constellation® Vision System IMPORTANT NOTICE 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 and CAUTIONS in this manual. WARNINGS are written to protect individuals from bodily harm. CAUTIONS are written to protect the instrument from damage. Illustrations contained in this manual are for reference only. It is recommended that maintenance be performed by a qualified Alcon Field Engineer.
Constellation® Vision System Comments or corrections concerning this manual should be addressed to: Alcon Technical Services Group PO BOX 19587 Irvine, CA, USA 92623 All rights reserved. No part of this manual may be reproduced, transmitted, or stored in a retrieval system, in any form or by any means; photocopying, electronic, mechanical, recording, or otherwise; without prior written permission from Alcon Laboratories, Inc.
Constellation® Vision System SECTION ONE GENERAL INFORMATION Introduction The Constellation® Vision System is a multifunctional surgical tool for use in anterior and posterior segment ophthalmic surgeries. The product’s capabilities include driving a variety of handpieces that provide the ability to cut vitreous and tissues, emulsify the lens, illuminate the posterior segment of the eye, and apply diathermy to stop bleeding.
Constellation® Vision System Table 1-1 CONSTELLATION® VISION SYSTEM SPECIFICATIONS - This table is a quick reference point to identify system specifications, system requirements, and performance figures. CONSOLE PERFORMANCE SPECIFICATIONS DIMENSIONS: Tabletop: Height: Width: Depth: PRESSURIZED INFUSION/IRRIGATION @SEA LEVEL: Range: 0 to 120 mmHg Accuracy: ±(2% of setpoint +5 mmHg) Flow Rate: 0 - 20 cc/min. for infusion (20 Ga) 0 - 60 cc/min. for irrigation Setpoint Transient: 500 ms maximum 160.
Constellation® Vision System Table 1-1 CONSTELLATION® VISION SYSTEM SPECIFICATIONS...continued PERFORMANCE SPECIFICATIONS...continued LOW PRESSURE AIR SOURCE (LPAS) @SEA LEVEL: Pressure Range: 0 – 120 mmHg at rated flow Pressure Accuracy: ±3% of Setpoint +3 mmHg Flow Rate: 1.2 slpm minimum at 120 mmHg VITRECTOMY: Submodes: Cut Rate: UltraVit™ 5000 Probe: UltraVit™ 2500 Probe: DIATHERMY: Frequency: Waveshape: Output power Power range 3D, Momentary, PropVac, VitWet 100 to 5000 cpm 100 to 2500 cpm 1.
Constellation® Vision System Table 1-2 Term or Abbreviation 1.4 Terms and Abbreviations Description BSS PLUS® Balanced Salt Solution enriched with bicarbonate, dextrose, and glutathione. cmH2O Centimeters of water. cpm Cuts Per Minute. Detent A discrete footpedal position at which more force is required to depress the footpedal to the next position. Diathermy The production of heat in body tissues by electric current for therapeutic purposes.
Constellation® Vision System Off Power Extrusion On Save Forceps Air Pressure Input ! Auto Gas Filling (AGF) Opens Operator's Manual Alternating Current Fragmentation Video Recorder Coagulation Connector Scissors Connector Connection Indicator Irrigation/ Aspiration Serial In/Out Dangerous Voltage Laser Phaco Footswitch Scissors Viscous Fluid Control (VFC) 1 Figure 1-2 8065751025 System Fault System Information Type BF Equipment Fuse Type B Equipment Hot U/S Handpiece Connector U
Constellation® Vision System Visible laser radiation. Avoid eye or skin exposure to direct or scattered radiation.
Constellation® Vision System System Installation In the USA contact the Alcon Technical Services Department for uncrating and installation at (800) 832-7827. Outside the USA contact your local Alcon affiliate. Source Air Pressure Requirements The Constellation® Vision System is designed to operate using different levels of source air pressure. The system operates automatically with pressures of 58 (4 bar) to 120 psi (8.3 bar). Between 4 bar and 5 bar, vacuum performance is reduced. Between 4 bar and 5.
Constellation® Vision System Environmental Issues Follow local governing ordinances and recycling plans regarding disposal or recycling of device components. WARNINGS! Laser: There are potential hazards when inserting, steeply bending, or improperly securing the fiberoptic. Not following the recommendations of the manufacturer may lead to damage of the fiber or delivery system and/or harm to the patient or user.
Constellation® Vision System 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.
Constellation® Vision System Table 1-3 Guidance and Manufacturer's Declaration - Electromagnetic Immunity - The Constellation® Vision System is intended for use in the electromagnetic environment specified below. The customer or the user of the Constellation® Vision System should assure that it is used in such an environment.
Constellation® Vision System Table 1-4 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Constellation® Vision System - The Constellation® Vision System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Constellation® Vision System USA – Federal Communications Commission (FCC) Compliance Statement This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference. 2. This device must accept any interference received, including interference that may cause undesired operation. Caution Change or modifications made to this equipment not expressly approved by Alcon may void the FCC authorization to operate this equipment.
Constellation® Vision System Europe – R&TTE Directive 99/5/EC This device complies with the requirements of the Council Directive 99/5/EC (R&TTE). Caution The radio equipment is intended to be used in all EU and AFTA countries. Outdoor use may be restricted to certain frequencies and/or may require a license for operation. Contact local Authority for procedure to follow. Note: Combinations of power levels and antennas resulting in a radiated power of above 100mW equivalent isotropic radiated power (e.i.r.
Constellation® Vision System Cautions and Warnings Please contact Alcon for instrument setup and in-service training. If you have any questions or require additional information, please contact your local Alcon representative or the Technical Services Department. For locations outside the USA, please contact your local authorized Alcon Service/Sales office.
Constellation® Vision System Cautions and Warnings Ultrasonic Handpieces Power loss may occur if handpiece tip is not securely tightened into Fragmentation and Phaco handpieces. WARNING! Use of a Phaco handpiece at power settings greater than 80% continuously for over 4 minutes can result in ultrasonic system failure. Allow the system to cool for 8 minutes between heavy usage of this type.
Constellation® Vision System Diathermy Function To ensure safe operation of the Diathermy function, use only Alcon cables and accessories. Diathermy performance can be guaranteed only when using Alcon Surgical components or Alcon-endorsed components. Cables should always be positioned in such a way that contact with the patient is prevented. See Figures 1-4 through 1-6 for diathermy power specifications.
Constellation® Vision System • The use of flammable anaesthetics or oxidizing gases such as nitrous oxide (N2O) and oxygen should be avoided if a surgical procedure is carried out in the region of the thorax or the head, unless these agents are sucked away. • Non-flammable agents should be used for cleaning and disinfection wherever possible. • Flammable agents used for cleaning or disinfecting, or as solvents of adhesives, should be allowed to evaporate before the application of HF surgery.
Constellation® Vision System Cautions and Warnings Footswitch Never pick up or move the footswitch by holding the cable. Damage may result. Cassette During initialization the drain pump is rotated to the home position; therefore, keep hands and fingers clear of cassette well during power-on initialization. Manually rotating the hub roller in the cassette well when power is on and a cassette is not installed can cause incorrect cassette loading and/or can cause injury to fingers.
Constellation® Vision System Cautions and Warnings Consumable Paks If any item in a consumable pak is received in a defective condition, Alcon is to be notified immediately. Do not use any of the contents if the sterile package is damaged or the seal is broken in any way. Paks are identified by lot number that provides traceability and should be given to the Customer Service Department.
Constellation® Vision System Figure 1-4 DIATHERMY POWER THROUGH 75 OHM LOAD Figure 1-5 DIATHERMY POWER VS. LOAD IMPEDANCE Figure 1-6 DIATHERMY OUTPUT VOLTAGE VS. OUTPUT CONTROL SETTING Note: Maximum output peak-to-peak voltage is about 140V without resistive load. 1.
Constellation® Vision System PRODUCT SERVICE For product service, please contact Alcon’s Technical Services Department at the number provided below. Operators experiencing problems with the system should refer to the Operating Instructions and Troubleshooting sections of this manual. A problem which persists should be referred to the Alcon Technical Services Department or your local authorized service representative.
Constellation® Vision System LIMITED WARRANTY Alcon Laboratories, Inc., will repair or replace at its option, any system or accompanying accessories (excluding the optical fiber) found to be defective in material and/or workmanship for a period of one (1) year from the date of initial installation. This warranty applies to the original purchaser of the system, when said system is properly installed, maintained, and operated in accordance with published instructions.
