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ese Strumenti Oftalmologici Instructions for Use and Maintenance Mod. VEGA LED-based UV Emitter CSO Srl - Costruzione Strumenti Oftalmici Escaneado con CamScanner i ‘IMO Via degli Stagnace, 12/6 -frazione BADIA A SETT! ° 50018, ‘SCANDICCI (FIRENZE) - ITALIA CONTENTS DESCRIPTION AND USE. STANDARD COMPONENTS... AMBIENT CONDITIONS FOR SHIPPING, WAREHOUSING, AND USE DATA PLATES AND LABELS COMMANDS AND SIGNALS. INSTALLATION AND COMMISSIONING. ASSEMBLY. CONNECTIONS on ELECTRICAL SAFETY: GENERAL PRECAUTIONS AND SAFETY WARNING: USE CONDITIONS, WARNINGS, AND PRECAUTIONS DISPLAY SETTINGS... EMISSION POWER CHECK. INSTRUCTIONS FOR USE. DISPLAY FUNCTIONS.. TREATMENT PROCEDURE TECHNICAL FEATURES.. REGULATORY COMPLIANCE INFORMATION... EQUIPMENT CLASSIFICATION, EQUIPMENT LIFECYCLE ROUTINE MAINTENANCE... CLEANING THE OUTER SURFACES PROTECTION FROM DUST REPLACING THE LINE FUSES ., PERIODIC SAFETY CHECKS... END-OF-LIFE DISPOSAL INFORMATION . LIABILITY... Escaneado con CamScanner (Ti) READ THIS MANUAL CAREFULLY DESCRIPTION AND USE VEGA is a medical electrical device designed and built by CSO Srl. It consists of a LED light source that radiates in the ultraviolet spectrum (UV-A). The instrument is designed to be used exclusively for treatment of disorders of the cornea, in an ophthalmologic clinical setting and only by expert specialized physicians. The VEGA emitter is especially useful in treatment of keratoconus by corneal collagen cross-linking. This technique consists in photo-polymerization of the stromal fibers through the combined action of a photo- sensitizing substance (riboflavin — Vitamin B2) and the UV radiation generated by the instrument in question. CSO Srl does not suggest any specific clinical use techniques or therapeutic procedures. The way the instrument is used and therefore, its association with particular pharmaceuticals and/or chemical agents, are left to the discretion of the specialized user physicians on the basis of their scientific knowledge and professional skills. ‘This manual provides all necessary instructions for practical use of the instrument and points out safety precautions and measures that operators should observe/take to minimize the risks directly connected with the technical characteristics of the instrument and in particular with emission of UV radiation. CSO Srl assumes no responsibility for damages or injury to patients, operators, and/or other persons attributable to improper or imprudent use of the instrument in manners different from those described in this manual, and in particular in case of failure to observe the safety precautions and measures outlined herein, Mod. VEGA + Instructions for Use and Maintenance - rev, 4= Page 3 of 26 Escaneado con CamScanner STANDARD COMPONENTS ‘The devise is composed of the following principal units: 1- OPTICAL HEAD 2- BALANCE ARM 3- CONTROL BOX 4- STAND. 5- FOOT SWITCH Standard accessories: ~ Power cord = Wrenches for assembly - UV light meter - This use and maintenance manual, Mod. VEGA « Instructions for Use and Maintenance - rev. 4+ Page 4 of 26 Escaneado con CamScanner AMBIENT CONDITIONS FOR SHIPPING, WAREHOUSING, AND USE As long as the instrument remains in its original packing it may be exposed to the environmental conditions listed below, for a maximum of 15 weeks during shipping and warchousing, without suffering damage: fion Attention! ‘Temperature between -10 T and +60 T, atmospheric pressure between 500 hPa and 1060 hPa, and relative humidity between 10% and 90%. Ambient conditions for operation are, instead: Temperature between +15 T © +30 T; atmospheric pressure between 700 hPa and 1060 hPa, and relative humidity between 30% and 75%. DATA PLATES AND LABELS CSO. stl Via degli Stagnecei, 12 '30010 SCANDICCI INVISIBLE LED RADIATION DoNor view pmEcTLY "WITMOFRCAL ISTRUAGNTS CLASS IM LED LED LASER APERTURE PRODUCT! exsou2s.12000) OPTICAL HEAD data plate ‘Mod. VEGA + Instructions for Use and Maintenance - rev. 4- Escaneado con CamScanner C.S.0. stl - Via degli Stagnacci, 12/B 50010 SCANDICCI (FIRENZE) - ITALY wwo1n0V~W18VA ourrut CONTROL BOX |ruses2315ma-520-Type dec 12) | Emission power: 4 mW (max) Mod. VEGA 230200 -~V 18VA Wavelength: 370 nm fuses 2x 160 mA $120-T ype (EC 127) Banwidas dam FREQ, £60 le . SERIAL NUMBER ” ace AN Cc € . i — 0051 SER USER MANUAL CONTROL BOX data plate FRONT PANEL UV.— Yellow light. Indicates UV-A emission from optical head. — Red light. Malfunction indicator. ‘Mod. VEGA + Instructions for Use and Maintenance - rev, 4~ Page 6 of 26 Escaneado con CamScanner REAR PANEL Explanation of Graphics Symbols on Data Plates C € asi “CE mark" attesting to product compliance with Buropean Union Diectve 93/42/EEC (Medical ‘Type B. Even though the instrument has no applied Devices"). The cde umber identifies the notified standards parts as such, the leakage cureat values are wikia type B inis ganization (IMO) charged with verifying compliance of the {EN 6060 safety standard fr eecricl medical devices). reduc andthe maufsctre's quality systems, LN svccnus cones ent erry jnsrocton manual care — separately collect and dispose of ead- en mate aeflly before installing, commissioning, Fr eecrical and elecwonie equipment (sce section on this sing the instrument. a Ou ‘Mod. VEGA + Instructions for Use and Maintenance - rev, 4- Page 7 of 26 Escaneado con CamScanner SS COMMANDS AND SIGNALS 13- UV SPOT APERTURE CONTROL 2.1- ARM LOCK 3.1- UV EMISSION INDICATOR (yellow light) 32+ MALFUNCTION INDICATOR (red light) 3.6- MAIN SWITCH 3.9- CONTROL BOX ROTATION LOCK S-FOOT SWITCH Mod. VEGA + Instructions for Use and Maintenance - rev. 4- Page 8 of 26 Escaneado con CamScanner Attention! Bofore switching on and using the Instrument, read this manual, and this ehapterIn particular, carefully. INSTALLATION AND COMMISSIONING Our instruments are always supplied packed in such a manner as to best withstand standard shipping and warehousing conditions. Should you notice defects attributable to shipping when unpacking the instrument, contact your installation service or the manufacturer. Check that your mains voltage is compatible with the specifications on the data plate of the instrument. If not, contact the technical assistance center or the manufacturer. = Your entire electrical system must comply with the CEI 64-4 standard or the more recent CEI 64-8 sect. 710 (Electrical Systems for Medical Use). In case of doubt, contact your electrical system installation and maintenance service. = Never use multiple plugs, adapters, or extension cords to connect the instrument plug to the mains socket. - When unplugging the instrument from mains power supply, even in an emergency, grasp the plug only; never pull the cord to disconnect the plug. - In order to avoid interruptions during treatment, we suggest connecting the instrument through an emergency power supply. Mod. VEGA - Instructions for Use and Maintenance - rev. 4- Page 9 of 26 Escaneado con CamScanner ASSEMBLY ‘© Assemble the arm (2) on the column, inserting the plate (2.2) inthe channel (4.1). Tighten the knob (2.1) to lock in place at correct height. ‘© Insert the optical head (3) onto the column (4). ‘© Adjust rotation friction by tightening the screw (4.2) with the wrench supplied for that Purpose. Mod. VEGA + Instructions for Use and Maintenance - rev. 4- Page 10 of 26 Escaneado con CamScanner © Assemble the optical head (1) on the arm attachment (2.2). '* Lock in place with the wrench supplied for that purpose. (1.1) CONNECTIONS 1.3- INSERT THE CONNECTOR, 3.4- INSERT THE CONNECTOR (foot switch) 3.5- INSERT THE CONNECTOR FROM THE ARM. 3.7- INSERT THE SOCKET CONNECTOR IN THE PLUG 3.7 (mains) 3.10- VIDEO OUT GI WG ‘Mod. VEGA + Instructions for Use and Maintenance - rev. 4- Page 11 of 26 Escaneado con CamScanner Attention! ELECTRICAL SAFETY: GENERAL PRECAUTIONS AND SAFETY WARNINGS = Never touch the power cord with wet hands. Check frequently that the cord is so placed as not to be stepped on or crushed by ‘weights, Never knot the cord. = A damaged power cord can cause fires or electrical shocks. Check frequently that the instrument power cord is in good condition. If it becomes necessary to replace the power cord supplied with the instrument, contact your supplier. = Do not perform any repairs or maintenance work on the instrument or the electrical system beyond what is explained in this manual. = Do not use the instrument near water and be careful not to spill liquids on any part of it. Avoid damp and dusty locations and locations subject to brusque changes in temperature and humidity. - Disconnect the instrument from the mains supply socket before cleaning and/or disinfecting. = The instrument neither generates nor receives electromagnetic interference when used in proximity o other devices; no preventive or corrective measures need therefore be taken. = The standard-configuration instrument is tested in accordance with international standards EN 60601-1 “Medical Electrical Equipment. PART I: General Requirements for Safety” and EN 60601-1 “Collateral Standard: Safety Requirements for Medical Electrical Systems” and is fully compliant with these standards. \Note that the standard version unit can be connected to other instruments, medical electrical and not; CSO cannot test the compliance of al possible system configurations. Any additional accessories (video recorder, monitor, or similar equipment) connected to the analog or digital interfaces must each be certified in accordance with the respective pertinent standards. ‘All such devices must in any case be located outside of the patient ‘area. = Once all the equipment making up the system has been connected ‘and assembled, check that the resulting medical electrical system complies with the requirements set by EN 60601-I-1 “Collateral Standard: Safety Requirements for Medical Electrical Systems.” - Should the leakage current values exceed the limits set by the pertinent standards, additional safety measures must be adopted as laid down by the EN 60601-I-1 standard. In this case, the entire sem mus sd through a safety insula = Attention! Do not connect devices not forming part of the system to the instrument, Mod. VEGA + Instructions for Use and Maintenance - rev. 4- Page 12 0f 26. Escaneado con CamScanner Attention! Although the VEGA emitter is not a true LASER, the risks of ‘damage to patients’ and operators’ skin and eyes are ‘analogous. LED RADIATION AVOID EXPOSURE TO BEAM DONOT OBSERVE WITH ‘OPTICAL INSTRUMENTS CLASS 1M LED DEVICE (EN 60825-1:2003) USE CONDITIONS, WARNINGS, AND PRECAUTIONS The VEGA emitter requires no warm-up period. Emission begins at the moment the instrument is switched on. ‘The user/operator must be aware of the general safety precautions to be taken when using devices of this type and of those set forth herein and on the safety labels on the VEGA emitter. The instrument is intended for use only by correctly and thoroughly trained personnel (specialized ophthalmologists) for appropriate therapeutic purposes, based on clinical observation of the tissues of the patients being treated. E skin may be seriously damaged by the UV radi emitted by the instrument, as pointed out herein and reported in specialized international literature. Only the portion of the patient's body that is to be treated should be exposed to the UV radiation. Do not interrupt the UV path with hands or objects. Do not look at the light source. The UV radiation emitted by the source is invisible. The operators’ eyes must be protected with suitable goggles, as must the eye of the patient that is not being treated. Do not use the device if there is any damage to the casing, the optical components, or the power cord. Medical and surgical instruments and other objects made of plastics present in the working environment may be damaged and/or emit noxious gases if irradiated by the UV radiation emitted by the device. The radiation (UV light) may reflect off smooth surfaces in the working environment, even if they are dark in color. Keep the instrument on only for the time strictly necessary for treatment. WARNING - Using commands and/or settings or running procedures different from those described in this manual may cause exposure to dangerous levels of radiation. ‘Mod. VEGA + Instructions for Use and Maintenance - rev. 4- Page 13 of 26 Escaneado con CamScanner DISPLAY SETTINGS DISPLAY CONTROLS: Attention! g Cod Do not alter the original MN Bunn Gf oon ae Gor nero Only adjust the “color” and “light” settings to obtain optimal display. If the display does not operate correctly, check that the “mirror image,” “v1/v2,” and “on/off display” selectors are set as shown in the figure above. Mod. VEGA + Instructions for Use and Maintenance - rev. 4- Page 14 of 26 Escaneado con CamScanner EMISSION POWER CHECK ‘We recommend checking the intensity of the radiation emitted by the] instrument priot to each treatment. The system is equipped with a UV meter (6) for checking emission power. The accessory is composed of a detector head (6.2) and a| display (6.1). The UV meter is an extremely delicate measurement instrument and! ‘must therefore be stored and handled with all due precautions. > When not in use, store the instrument, with its protective cover, ina safe place not exposed to humidity or sources of} heat. > Do not expose the instrument to extremes of temperature. Do not expose to strong vibrations. > Do not use near sources of magnetic fields (motors transformers, e.). > Before taking any reading, allow a few minutes’ time on-site for instrument temperature to stabilize. > Replace the batteries immediately whenever the “BAT") symbol is displayed. > If the instrument is unused for a long period of time, remove the batteries. Do not open the instrument or tamper with its parts. Control and calibration may be performed only at CSO. > For further information regarding the UV meter, refer to the original instruction manual. v vv The UV meter is an instrument that has been modified and is certified] by CSO. It may not be used for purposes other than those described herein. ‘Mod. VEGA + Instructions for Use and Maintenance «rev. 4- Page 15 of 26 Escaneado con CamScanner EEO “i @ @ fae Attention! To take a UV reading, proceed as outlined below: at ey The optimal measured value should be 3 mW/cm*, or in any case within a tolerance range of 2.7 to 3.3 mW/cm? otherwise waiting for 15’ in “POWER ON CHECK” mode after that repeat the! measurement. Should the measured value not meet tolerance, check whether or| 3. Switch on the main switch (3.6) of the power supply (3). 4, Position the optical head over the aperture (Fig. 6.3) of the UV not: a) The mains voltage is correct. b) The cables are connected correctly. ©) The power supply fuses are good. d) The head of the UV emitter is clean. ¢) The UV meter batteries are charged. Place the UV instrument on a flat horizontal surface. Check that in the absence of emissions and interference, the| reading on the display (6.1) is “0” with a tolerance of +/-0,05 mW/cm? (zero reference reading). meter and move it toward the plane inside the aperture until the image on that surface comes into focus (the two flashing! iridescent projections overlap). Switch on the UV emitter with the foot switch (5); in the| “POWER ON CHECK” mode, move the UV meter over the plane until the UV emission intercepts the detector aperture] (Fig. 6.4) in the center. The diaphragm (1.3) must be at the! maximum open “I1 On the display (6.1), read the power density value expressed| in mW/em. | Press the foot switch again to move ahead to the treatment] phases. f) The procedure described above has been carried out| correctly. If it be the case, repeat the entire procedure from the beginning. If the problem persists despite the above checks, contact your retailer or CSO. Mod. VEGA + Instructions for Use and Maintenance - rev. 4- Page 16 of 26 Escaneado con CamScanner Attention! INSTRUCTIONS FOR USE ‘Switch on the main switch of the instrument (9). Bring the optical head (1) toward the patient and center the image o hishher eye at the center of the monitor screen. For best results, the emitter must be correctly focused; the focus point is located about $4 mm from the apex ofthe optical head. For quick] focus search, tse the collimating light beams (1.2): two flashing iridescent lines projected at a certain angle which when their paths meet ata single point, permit finding the correct focus position (see figure below). Correct focusing ensures correct UV emission power density for! meeting medical procedure guidelines (3mW/em*) only at this, focus point. OPTICAL HEAD | Mod. VEGA + Instructions for Use and Maintenance - rev. 4~ Page 17 of 26 Escaneado con CamScanner — DISPLAY FUNCTIONS ‘The instrument is equipped with a display (3.8) that supplies all the information relative to the treatment procedure to be followed. The text line displays the TIME (3.8.3, minutes and seconds) for each phase, the STATUS (3.8.2), and the single STEP (3.8.1) on which we are working. STATUS (.8.2)- © WAIT- The instrument is waiting for a command to begin a phase or the entire procedure. RUN- One of the operative phases is running. PAUSE: The foot switch has been pressed during a phase of the procedure and the instrument is waiting for new input, Press the foot switch again to resume work from the point of interruption. # RESET- The foot switch has been held down for 10 seconds and the instrument is, consequently resetting to the top of the first phase. Mod. VEGA ~ Instructions for Use and Maintenance - rev. 4- Page 18 of 26 Escaneado con CamScanner e steps in memory are 7 in number and follow the procedure dictated by medical The first phase (STEP 0) is the only step that may be modified by the physician. This phase lasts 30° but mat be interrupted to go on to step 1. Steps 1 through 6 cach have a duration of 5’ for a total 30°. TIME (3.8.3)- The elapsed time for each step is displayed in minutes and seconds. STATUS (3.8.4)- * POWER ON CHECK- The first phase of operation: the power check to be conducted with the aid of the UV meter. RESUMED- The system has resummed operation from the phase and time at which power supply was interrupted. STEP (3. If treatment is interrupted due to failure of the external power supply, the system memorizes the lapsed treatment time. When the instrument is repowered, treatment can be resumed from the point in time stored in memory. TREATMENT PROCEDURE Position the optical head above the patient and align it, finding the focus point as described above. ‘© Press the foot switch to start step 0. After 30’, at the physician’s discretion, press the footswitch again to return to WAIT status. Press the foot switch to start step 1, which will last 5’. The system will then automatically shift to WAIT status awaiting the next step. Proceed with the remaining steps until the entire procedure is concluded. Upon termination of step 6, the system will automatically return to WAITing for step 0. ‘Mod. VEGA - Instructions for Use and Maintenance = rev. 4- Page 19 of 26 Escaneado con CamScanner TECHNICAL FEATURES Power supply Single phase AC mains supply 100, 120, 230, 240 V, 50/60 Ha Rated power 18 VA (max) | UV source LED emitting in the UV-A spectrum Emission Peak wavelength: 370 nm | characteristics Spectrum width: & nm (at half amplitude) | aw i2 3 1 5 08 4a | £08 2 G 04 #02 é ° 300 350 400 450 500 Wavelength[nm] Emission spectrum Radiated power 4 mW (max) Radiated power 3 mW/em’ (max) density Diameter of Variable inradiated area Min @.4mm Max O11 mm Collimation 1 pair red LEDs Work distance = $4mm Fixation Fixation LED green color Video camera In optical head Minicamera, 1", color, model ECH-3030ST Monitor Display monitor, 5.6", color, model SJD-56S Video out 75-Ohm PAL video-composite output Dimensions 1260 ~ 545 - 1360 mm Weight Wkg ‘Mod. VEGA + Instructions for Use and Maintenance - rev, 4- Page 20 of 26 Escaneado con CamScanner According to EN 60601-1 ‘safety standard According to CEIEN 60825-1 safety standard According to Annex IX of Directive 93/A2/EEC REGULATORY COMPLIANCE INFORMATION ‘The VEGA jis designed and built in compliance with BU Directive 93/42/EEC and the following harmonized standards: = CEL EN 60601-1:1991 "Medical Electrical Equipment ~ Part General Requirements for Safety” as amended. = CEI EN 60825-1:2003 ~ “Safety of Laser Products - Part 1: Equipment Classification, Requirements, and User Guide. = CEL EN 60601-1-2:2001 - “Medical Electrical Equipment ~ Collateral Standard: Electromagnetic Compatibility.” EQUIPMENT CLASSIFICATION Portable device (movable from one location to another). Protection against direct and indirect electrical shock: Class I Type B Compliance level for protection against humidity: ‘Common devices (IP20) (no protection against infiltration of water) ‘Method of sterilization or disinfection: Disinfectable device Compliance level for protection in the presence of inflammable anesthetic mixtures: No protection Use conditions: continuous service LED RADIATION in the UV-A range, class IM, for medical use. Class II b (Rule 9, Annex IX) Mod. VEGA + Instructions for Use and Maintenance - rev. 4- Page 21 of 26 Escaneado con CamScanner EQUIPMENT LIFECYCLE Regular maintenance, as specified in the use and maintenance ‘manual, permits maintaining the basic characteristics of the ‘equipment unaltered for many years, even when it is subjected to intense use. It is nevertheless normal for the device to gradually age; aging is in strict relation to the manner and frequency of use (wear of mechanical parts, drift of electricaVelectronic components, deterioration of insulation), For reasons of prudence, the working life of the device is therefore set at fen vears from the date of commissioning (re: Annex I Directive 93/42/EEC). Mod. VEGA + structions for Use and Maintenance = rev, 4- Page 22 of 25 eer ciate ian Escaneado con CamScanner Attention! Unplug the power cord from ‘mains supply before performing any of the ‘routine maintenance ‘operations illustrated in this section. ROUTINE MAINTENANCE ‘The device requires no particular routine maintenance by the user. CLEANING THE OUTER SURFACES Clean the extemal surfaces of the instrument with a cloth slightly dampened with water. Do not use thinners or solvents. PROTECTION FROM DUST When the instrument is not in use, protect it from dust by covering it with the protective cover. Periodically remove any dust that has accumulated on the instrument with a very soft cloth or a hand-operated pump. REPLACING THE LINE FUSES Extract the fuse-holder box (3.7.1) and replace the blown fuses with new fuses of the same rating. To replace the line fuses, proceed as described below. = Before beginning any work, unplug the instrument to isolate power supply. - Extract the fuse-holder box (3.7.1) and remove the blown fuses. = Replace the old fuses with new ones compatible with mains power supply, as indicated on the data plates. Cheek that the voltage changer on the fuse-holder box (3.7.1) Attention! : is set tothe correct voltage value for your mains supply. Ifnot, Special maintenance extract the box (3.7.2) and turn until the correct voltage value (repairs, replacement of appears in the window. components, internal parts ~ Replace the voltage-changer/fuse-holder box. checks, periodic safety ~ Plug inthe instrument. checks, etc) is the exclusive ‘competence of the CSO a technical assistance service. 7.2 7A Mod. VEGA Instruction for Use and Malatenance «rev. 4 Page 23 0f 26 Escaneado con CamScanner Attention! The periodic safety checks are the exclusive competence of the CSO technical assistance service. PERIODIC SAFETY CHECKS We recommend having the Mod. VEGA checked periodically, as recommended by the CEI Guide 62-122:2002 concerning acceptance testing and periodic checkouts of the performance and/or safety of| medical devices powered by particular power sources, by a technical service center authorized by CSO stl. The Mod. VEGA instrument is designed and built in full compliance with applicable laws and standards and must pass rigorous safety testing before leaving the factory. We nevertheless recommend (as the above-mentioned standard suggests for all medical electrical equipment) conducting a safety checkout once every two years in ~ accordance with applicable procedures, in order to limit the possibility of breakdowns and/or fallofis in performance levels. Please contact CSO stl for further information. Letteratura tecnico-scientifica di riferimento NP | Treaine ‘lineal evidence Contra Side feds is indications ations T | Medical | Selena Scteifc erature “Tote exchdadim exes of | -Transtory treatmen | “Terapia medica del heratocono | atin with reduced corel | comeal edema tof | mediante croselinking del collagene | thicknesses (<400 ym) | ~ Sensation of Keratoco_ | corneale con eboflavina- feign body for mus | ultravioltto” 2005) 2448 hours (Medical Therapy of kerstoconus by Burning ‘comeal collagen erossnking with sensation in eye ‘boflavinultravolet radiation) snd lackzyrnstion ‘Authors: Caporosi, Mazzi, Travers Baiocchi etal Depart of Ophthalmological and ‘Neurosurgical Sciences ~ Opithalmciogy Complex ~Siena University, Eye Clinic “Cars” Technical University -Dresden Further Bibliography: for the treatment of kerat IWOLLENSAK, SPOERI IWOLLENSAK, SPOERL et al. “Riboflavin/Ultraviolet-A-induced collagen cross-linking) {treatment in the rabbit.” J Cataract Refract Surg, 2003. WOLLENSAK, SPOERL et al. “Keratocyte apoptosis after comeal collagen cross-linking using Riboflavin/UV-A treatment.” Cornea, 2004. toconus.” American Journal Ophtalmol — 2003. Let al. “Endothelial cell damage after Rriboflavin-Ultraviolet-A\ /See also: expertise document by Caporossi, Mazzotta, Balochi, August 2006. ‘Mod. VEGA = Instructions for Use and Maintenance -rev.4- Page 24 of 26 Escaneado con CamScanner The symbol (barred waste can) shown in the figure and found on the exterior of the Instrument indicates that the electrical and electronic parts of the end-of-life instrument must be separated and disposed of as special waste. END-OF-LIFE DISPOSAL INFORMATION in accordance with Art. 13 of the Italian Leg. Decree No. 151 ‘of 25 July 2005 Implementing Directives 2002/98/EC, 2002/96/E.C, and 2003/108/EC concerning reduction of use of dangerous substances In electrical and electronic equipment and disposal of electrical and electronic waste, cular materials and ‘The instrument you have purchased is made using particular material substances. It may also contain substances having potentially dangerous fffects on the environment nd hurnan health if released into the environment bby improper disposal ‘To avoid releasing dangerous substances into the environment and in order to promote conservation of natural resources, should the user decide to dispose fof an end-ofilife instrument the manufacturer will facilitate reuse and recovery and recyeling of the materials it contains. , Government agencies have adopted measures obliging users, distributors, and manufacturers to conttibute to collection of waste electrical and electronic equipment (WEEE) and prescribes that such equipment be reused or be recovered oF recycled, ‘When disposing of the instrument, remember that disposal is regulated by precise European and national Taws and regulations that prescribe the following: = Do not dispose of the instrument 2s ordinary municipal waste. For separate collection contact a company specialized in disposal of waste clectical and electronic equipment or your local waste disposal agency for information. = Ifa new instrument is purchased from the same manufacturer to replace an end-ofife instrument put on the market before 13 August 2005, of an equivalent type and performing the same functions as the new device, the

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