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 8065751131 Rev. P3.5, CATALOG NUMBER 905-5620-001 Rev. P3.5, TEXT ONLY © 2007 Alcon, Inc.
PurePoint™ Operator's 8065751131 MANUAL REVISION RECORD DATE REVISION ECN NUMBER AND DESCRIPTION CSO is a registered trademark of Costruzione Strumenti Oftalmici S.R.L. Nikon is a registered trademark of Nikon Inc. Corporation. Topcon is a registered trademark of Kabushiki Kaisha Topcon Corporation. Meditec is a registered trademark of Meditec Reinhardt Thysel GMBH. Ellex is a registered trademark of Taracan Pty. Ltd. Zeiss is a registered trademark of Carl-Zeiss-Stiflung.
TOPIC TABLE OF CONTENTS PAGE # Manual Revision Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi Important Notice. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 2-10 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 3-1 Figure 3-2 Figure 3-3 Figure 3-4 Figure 3-5 Figure 3-6 Figure 3-7 Figure 3-8 Figure 4-1 Figure 4-2 Figure 5-1 Figure 6-1 Figure 6-2 Fig
FIGURE # Figure 6-9 Figure 6-10 Figure 6-11 Figure 6-12 Figure 6-13 Figure 6-14 TABLE # Table 1-1 Table 1-2 Table 1-3 Table 1-4 Table 1-5 Table 2-1 Table 4-1 Table 6-1 Table 6-2 Table 6-3 8065751131 TITLE LIST OF ILLUSTRATIONS PAGE # Alcon LIO-AT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.10 Alcon LIO-AT Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
FOREWORD This Operator's Manual is designed to acquaint the operator and operating room personnel with the Next Generation Laser. 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.
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.
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SECTION ONE GENERAL INFORMATION INTRODUCTION The Alcon PurePoint™ Laser provides an exceptional combination of performance, solid-state reliability, versatility, and portability all in one system. It is a diodepumped solid-state type laser designed for ophthalmic use. This laser delivers a visible 532 nm green treatment beam, and a visible 635 nm Diode Laser aiming beam (635 nm is an approximate value between 630-640 nm).
Table 1-1 Technical Specifications CATEGORY Approximate Dimensions Approximate Weight Electrical Characteristics Environmental Limitations SPECIFICATION Width: 0.23 m (9.00 inches) Depth: 0.34 m (13.50 inches) Height: 0.18 m (7.00 inches) 10.4 kg (23 lbs) Voltage: 100-120 VAC@ 5 A (max current) 220-240 VAC @ 2.
WARNINGS! There are potential hazards when inserting, steeply bending, or improperly securing the fiber optic. Not following the recommendations of the manufacturer may lead to damage to the fiber or delivery system and/or harm to the patient or user. Since the aiming beam passes down the same delivery system as the treatment beam, it provides a good method of checking the integrity of the delivery 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.
Table 1-4 Guidance and Manufacturer's Declaration - Electromagnetic Immunity - The PurePoint™ Laser is intended for use in the electromagnetic environment specified below. The customer or the user of the Next Generation Laser should assure that it is used in such an environment.
Table 1-5 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the PurePoint™ Laser - The PurePoint™ Laser is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
FCC and IC Compliance Statement Equipment contains Radio Frequency Identification (RFID) device. Operating Frequency: 13.56 MHz Type of modulation: Amplitude Shift Keying (ASK) Output power (e.i.r.p): 703 nW This device complies with Part 15 of the FCC Rules and with Industry Canada Radio Standards Specification RS-210.
LABELING Figure 1-2 shows the labeling found on the PurePoint™ Laser. Alternating Current Off Aiming Beam On Dangerous Voltage ! Equipotentiality Consult Operator's Manual, or System Error or Advisory Ready Footswitch Standby State Fuse SYSTEM FAULT System Fault Illumination System Information Keyswitch Type BF Equipment Laser Connection Laser Emergency Stop Switch 1 Laser Port Figure 1-2 1.8 USB Connector Use appropriate take-back system (see Environmental Considerations in this manual).
Carrying Case The carrying case shown in Figure 1-4 is included with the system and intended to be used as an aid to carrying the system. CAUTION The carrying case should not be used for shipping the system. Figure 1-4 8065751131 The PurePoint™ Carrying Case 1.
PREPARING FOR INSTALLATION The PurePoint™ Laser system was thoroughly inspected and carefully packaged for shipping. If the container is damaged, leave system in original container with packaging and request inspection by the carrier within 3 days of delivery. Included as part of the packaging is the carry box for the PurePoint™ Laser. This container is intended to protect the system when moving it from one location to another. Use the carry box whenever the system must be moved.
NOTE: The accessory equipment connected to or used with this equipment must be certified according to the respective IEC standard; e.g., IEC 950 for data processing equipment (data processing equipment must not be used during patient treatment) and IEC 601-1 for medical equipment. Additionally, all configurations shall comply with the system standard IEC 601-1-1.
REMOTE CONNECT 1 CUSTOMER SUPPLIED DOOR SWITCH (OPTIONAL) 6 9-PIN D-CONNECTOR 1 COM NC 9 NO TO DRIVE DOOR LAMP (OPTIONAL) 3 Figure 1-5 Remote Connector/Door Lamp Circuit Diagram Utility Requirements Electrical requirement: The PurePoint™ Laser has a power supply that operates at 100-120 V and 220-240 V input ranges at 50/60 Hz. A properly grounded, standard plug is the only requirement.
PUREPOINT™ LASER SAFETY FEATURES The PurePoint™ Laser is designed for the highest degree of reliability and maximum safety for both the operator and the patient. Any misuse of this laser system may be dangerous. Before using the laser system, the operator must be familiar with the commands and the manipulation of this type of instrument.
PROFESSIONAL OPERATOR’S INFORMATION The following information is given to provide the operator with specific information regarding the PurePoint™ Laser ophthalmic laser. Indications The PurePoint™ Laser is indicated for use in photocoagulation of both anterior and posterior segments of the eye including: 1.
Effects The laser beam is primarily absorbed by pigmented tissues within the eye. These primary pigments are hemoglobin/oxy-hemoglobin and melanin. In the case of macular treatment, xanthophyll pigment is involved. The surgeon controls the power, spot size, and exposure time of the delivered laser beam to the targeted tissue. It is the combination of these effects that results in the thermal action of the laser beam upon tissue. One or all of the adjustable parameters can be changed.
Delivery of Laser Energy The laser beam is delivered to tissue via a Slit Lamp, Endoprobe, Illuminated Endoprobe, aspirating Endoprobe or Laser Indirect Ophthalmoscope (LIO). When using a Slit Lamp, the laser beam is often used in combination with various contact lenses to aid in treatment of particular targets such as the fundus. These contact lenses enable the laser beam to be directed to different sections of the eye.
message clears. If using a non-tethered fixed filter, and the system is switched from Standby to Ready mode, the message "Verify appropriate Dr. Filters are installed in all viewing devices" appears and the user must verify before the laser can switch to Ready mode. If two tethered filters are in place (see rear panel description), both filters must be switched into the beam path before the laser will operate.
Side Effects Corneal burns, inflammation, loss of best-corrected visual acuity, loss of visual field, and transient elevations in intraocular pressure can occur as a result of ophthalmic laser treatment. Unintentional retinal burns can occur if excessive treatment beam power or duration is used. Laser Safety Back scattered radiation is of low intensity and is not harmful when viewed through a protective filter.
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.
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.
