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User Manual for CLX-T Xenon Light Source
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1. Light Attenuation e _ The CLX T has a manually operated light intensity ring to CLX T Front View control the desired light output level To increase the light output rotate the ring clockwise until the desired level is reached See Figure 5 Turret Operation Rotate the Turret Fig 5 to select the appropriate port for your light guide The turret has ports for Wolf ACMI Storz and Olympus light guides The active port shows a green indicator light when the unit is on The active port is at the 12 o clock position Figure 5 Attenuator ring Each port has a light blocking feature So when a cable is removed no light is emitted Therefore it is important to note the active port so that the proper cable is connected to the correct port Turret XENON LAMP REPLACEMENT Warnings Disconnect the light source from main power and allow the equipment to cool before handling the Xenon lamp Use protective eye face and hand equipment when handling the Xenon lamp Please know that Xenon lamps have been known to explode The chance of this happening when the lamp is handled properly is very low The chance of injury if the lamp should explode are very high if the proper precautions are not taken The chance of a lamp failure while the light source is not in operation is very rare Each lamp is tested thoroughly during manufacture to ensure against failure Figure 6 a Figure 7 Retaining clips locked It is re
2. Source Equipment and Systems that are NOT Life Supportine The CLX T Light Source is intended for use in the electromagnetic environment in which radiated disturbances are controlled The customer or user of the CLX T Light Source can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the CLX T Light Source as recommended below according to the maximum output power of the communications equipment Recommended Separation Distances for the CLX T Light Source meters 150 kHz to 80 80 to 800MHz 800 MHz to 2 5 GHz Maximum AAI MHz Output Power Wats d 1 17VP d 2 334 P d 1 174 P 2 P PRODUCT WARRANTY Luxtec warrants that the CLX T light source except the lamp shall be free from defects in material and workmanship under normal use and service for a period of three 3 years from the date of shipment from Luxtec Luxtec s sole and exclusive liability under the warranty shall be at Luxtec s option either to repair or to replace any component which fails during the warranty period due to any defect in workmanship or material F O B factory if 1 Customer promptly reports such defect to Luxtec in writing 2 If requested by Luxtec customer returns equipment to Luxtec at the customer expense and 3 Upon inspection Luxtec finds the equipment to be defective This warranty is contingent upon normal and proper use of the e
3. Systems The CLX T Light Source is intended for use in the electromagnetic environment specified below The customer or user of the CLX T Light Source should assure that it is used in such an environment Electromagnetic Enforcement guidance RF Emissions Group 1 The CLX T Light Source uses RF energy only for its internal function CISPR 11 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions Class A The CLX T Light Source is suitable for use in all establishments CISPR 11 including domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonics Complies or Complies IEC 61000 3 2 Not applicable Flicker Complies or Complies IEC 61000 3 3 Not applicable Ale Electromagnetic Compatibility EMC User Information Guidance and Manufacturer s Declaration Immunity All Equipment and Systems The CLX T Light Source is intended for use in the electromagnetic environment specified below The customer or user of the CLX T Light Source should assure that it is used in such an environment Immunity Test eae TESI Compliance Level Electromagnetic Environment Guidance Electrostatic Discharge ESD IEC 61000 4 2 Electrical Fast Transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input l
4. 100V to 240V 50 60Hz as appropriate three conductor outlet Grounding reliability is guaranteed only when connected to a hospital grade receptacle me el Controlling Lamp Operation The main power on off switch is used to power the unit on or off See Figure 3 Figure 3 The on standby switch is used to select lamp on or Retaining screw lamp standby See Figure 4 Main power on off switch The light source requires both the main power and the standby switches to be in the on state for the lamp to operate When the lamp starts operating there is a brief clicking sound which is normal If the main power on off switch is used to toggle lamp operation leaving the standby CLX T Back View switch in the on state then there will be a short delay 3 or 4 seconds after turning the main power switch to the on position before the lamp will energize This delay will not occur when the standby switch is used to control the lamp Note that if the light source is left in standby with power Figure 4 Active Port Indicator applied with the main power on off switch in the on position and the on standby switch in the standby state fore zy Cn standby switch the unit will consume a small amount of power and be De slightly warm to the touch This is normal and permits the lamp to quickly energize with the on standby switch When the lamp is operating the active port indicator will illuminate See Figure 5
5. LUNTEC j User Manual for CLX T Xenon Light Source Fabler oFSYMbBOS esaa EE 1 General Warnings cccccec cece cece eee eneeeeeeneteeeneteeesaeeeeneeees 2 OS OV EET enon A nen nnse A 3 COC atl OM encase E E E EE AE A EE T ATE N 4 Xenon Lamp Replacement cccccccecccccceceeeeeeeeessuugaaees 5 6 Optional Floor Stand Installation ccc cece cence eee eaten eeeneees 7 EOUIDIMEN Cc FANS LIST wees scene to E EAEE EOS 8 TF FOUDIE SOONG annen EE Eee Dee lens 9 Maintenance and Cleaning ccccccee cence ee eeeeeeeeeeeeeeegeenes 10 DS CHICA TONS serierna EE Ea Aa deaenamunennee 10 Electromagnetic Compatibility EMC User Information 11 14 Proouct Warahi essensen ent n rense rele KER TEET 15 Repair and Return onannnannnannnnnnnnnnnnnnrrnnrnrnnrrnnrrnnnnnnrrrnnn 15 TABLE OF SYMBOLS Found on Light Source A Reiser Bb mente W rece eaupmen CD sane JN High Voltage F sse D ee High Temperature ON power C CE marking of conformity b Equipotentiality O OFF power FIRE HAZARD Do Not drape or cover the light source while it is operating EXPLOSION HAZARD Do Not use in the presence of flammable anesthetics ELECTRIC SHOCK HAZARD Do Not Open the light source if it is not functioning properly or if damage is apparent such as case damage or loose screws Refer to the Repair and Return Section of this Manual e The User of this equipment should car
6. ce Model Name CLX T Light Source Council Directive Medical Device Directive 93 42 EEC Classification Class I rule 1 Annex IX Self Declaration of Conformity Annex VII EU Classification Class I according to Rule 12 Annex IX CE Mark first applied June 2007 Authorized EU Representative Medical Products International Europe B V Schutweg 13 a 5145 NP Waalwijk The Netherlands Telephone 31 0 416563 754 FAX 31 0 416 563 926 I the undersigned hereby declare that the medical device specified above complies with the Essential Requirements of EC Directive 93 42 EEC for a Class medical device Signature L Rita Wadleih Quality and Regulatory Manager Date of original Declaration June 2007 Date of this revision June 2007 P N 850411 Rev C
7. column Seat firmly 2 Insert assembled column into base Seat firmly 3 With the handle screw positioned at the top of the handle slide the handle onto the upper column so there is about 5 inches 13 cm of space between the handle and the top of the column Tighten handle screw to hold in place 4 Fully insert post of the CLX T base plate into plastic bushing on top of upper column 5 Loosen handle screw and position handle opposite power cord hanger Adjust height as preferred by user and firmly secure handle screw 6 Secure CLX T to base plate by aligning mounting screws to screws holes on bottom surface of CLX T and tighten See Figure 9 EQUIPMENT amp PARTS LIST To place an order contact your local Luxtec distributor or call Luxtec Customer Service at 800 325 8966 USA or 1 508 835 9700 International Light Source 00 CLX T CLX T Xenon light source 85041 1 User Manual for the CLX T Lamp 00 1187 CLX T Lamp replacement module Power Cords 601949 AUSTL6M Australian Power Cord 6m 601949 EUR6M European Power Cord 6m 601949 UK6M UK Power Cord 6m 601949 US6 1M Hospital Grade USA Power Cord 20 Other parts 005418 CLX T floorstand bracket top base only 601915 screw 6 32 x 0 5 601919 Fuse 3 15A 250VAC 5x20mm Slo Blo IEC Standard Front View Rear View No light output Cable not installed Install cable to open light blocking feature Both switches are not on Turn main power switch o
8. commended that the Xenon lamp part no 00 1187 be replaced at 500 hours of usage Lamp usage is monitored by the hour meter on the rear panel of the CLX T When replacing the lamp the date and number of hours should be recorded to track the aging of the new lamp To remove the lamp 1 Make sure the main power on off switch is turned off Disconnect the power cord 2 Allow the unit to cool down for a minimum of 15 minutes before replacing the lamp The lamp may represent a burn hazard if not allowed to cool sufficiently prior to servicing the unit 3 Remove the retaining screw located at the back of the at the CLX T See Figure 3 The retaining screw also acts as a power interlock switch Once the screw is removed the unit cannot be turned on The screw must be replaced prior to turning the unit on 4 Slide the top cover of the CLX T towards the back of the unit See Figure 6 5 Unlock the lamp retaining clips holding the lamp in the CLX T Grasp and pull the lamp straight up See Figure 7 XENON LAMP REPLACEMENT To replace the lamp 1 Orient lamp to face forward See Figure 8 Lower lamp into the CLX T with lamp against fan See figure 9 The lamp receptacles must engage with lamp base plugs Press firmly into place to seat lamp Note Do not touch lamp glass window 2 Snap the lamp retainer clips located on each side of the lamp onto the top of the lamp The lamp is now ina locked position See Figure 6 3 Fully slide the t
9. efully read the Users Manual and be familiar with the set up use and care of the light source before using it The instructions in the Users Manual should be followed carefully with special attention to warnings and control features on the light source The Users Manual should be readily available to users and other appropriate personnel e Before each use ensure that the light source is not damaged and is operating properly Ensure that cooling vents and fans are free of obstruction e The light source generates high intensity light that can heat objects in its path This light can cause flammable materials to burn or cause burns to skin Prevent flammable materials from coming into close proximity with the output of the light source and light cable e The light emitted from the light source and the light cable can cause eye damage if viewed directly for more than momentary periods of time Do not look directly into the light source or the cable Do not point the light cable at another person s eyes For this reason this product must not be used in ocular surgery or in any surgical procedure requiring direct illumination of the eye e Avoid extreme heat or jarring of the light source to maintain the integrity of the Xenon lamp Refer to the Xenon Lamp Replacement Section of this Manual when replacing the lamp or removing it for any reason e Follow the instructions of other manufacturers equipment when using them in conjunction with this light so
10. es of the ESG were at a distance of 6 from the CLX T and the ESG was energized in the cut and coagulate modes The functioning of the CLX T was not effected by exposure to this energy The results of this testing are available from Luxtec Guidance and Manufacturer s Declaration Emissions Equipment and Systems that are NOT Life Supporting The CLX T Light Source is intended for use in the electromagnetic environment specified below The customer or user of the CLX T Light Source should ensure that it is used in such an environment Immunity IEC 60601 Compliance Electromagnetic Environment Guidance Test Test Level Level Conducted RF 3 Vrms from V1 3 Vrms Portable and mobile RF communications equipment should be separated from the CLX T Light Source by no less than IEC 61000 4 6 a ing the recommended separation distances calculated listed below D 1 17VP IEC 61000 4 3 80 MHz to 2 5 GHz D 2 33VP 800 MHz to 2 5 GHz Where P is the maximum power rating in watts and D is the recommended separation distance in meters Field strengths from fixed transmitters as determined by an electromagnetic site survey should be less that the compliance levels V1 and E1 Interference may occur in the vicinity of equipment containing a transmitter 243 2 Electromagnetic Compatibility EMC User Information Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the CLX T Light
11. ines IEC 61000 4 11 Power Frequency 50 60Hz Magnetic Field IEC 61000 4 8 6kV contact Floors should be wood concrete or ceramic tile If floors are synthetic the relative humidity should be at least 30 6kV contact 8kV air 8kV air 2kV on AC Mains 2kV on AC Mains Mains power quality should be that of a typical commercial or hospital environment 1kV Differential 1kV Differential Mains power quality should be that of a typical 2kV Common 2kV Common commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the CLX T Light Source requires continued operation during power mains interruptions it is recommended that the CLX T Light Source be powered from an uninterruptible power supply or battery gt 95 Dip for 0 5 Cycle gt 95 Dip for 0 5 Cycle 60 Dip for 5 Cycles 60 Dip for 5 Cycles 30 Dip for 25 Cycles 30 Dip for 25 Cycles gt 95 Dip for 5 Seconds gt 95 Dip for 5 Seconds Power frequency magnetic fields should be that of a typical location in a typical commercial or hospital environment 12 Electromagnetic Compatibility EMC User Information Please note The CLX T light source has been successfully tested to IEC 60601 2 25 The CLX T was in the presence of an electrical surgical generator ESG generating a field strength of between 18 and 23 V m During the testing the energized prob
12. ly consists of Wolf ACMI Storz and Olympus light guide ports The turret assembly should be rotated to the 12 o clock position to select the proper port for your light guide A green indicator shows which port is active when the unit is on CLX T Rear View Figure 1 CLX T Front View Figure 2 On standby switch Turret Main power on off switch Power cord receptacle Attenuator rin Hour meter J Inspection Before Use The CLX T light source comes with a hospital grade power cord Please verify that both the light source and the power cord have been received undamaged All fiber optic light guides should be properly cleaned and sterilized prior to first time use See light guide manufacturer s manual for information Warnings FIRE HAZARD DO NOT DRAPE OR COVER THE LIGHT SOURCE WHILE IT IS OPERATING Explosion Hazard Do not use in the presence of flammable anesthetics liquids vapors gases or dusts Electric shock hazard If unit is not functioning properly DO NOT OPEN Please refer to the Repair and Return Section of this Manual Use care not to point any light guide directly at the eye while operating the Light Source Keep cooling and fan vents free of obstructions Do not use or store liquids on or above the Light Source When Light Source is not in use turn off the power switches on both the front and the back of the CLX T Setting Up Before turning power on make sure the unit is plugged into any standard
13. mps Classification Type CF Class 1 IEC 60601 1 Conducted and radiated emissions Class B IEC 60601 1 2 PFC Conformance Harmonics and Flicker IEC1000 3 2 and IEC61000 3 3 Environment Storage 0 C 50 C 32 122 F 10 85 Relative Humidity Non Condensing Operating 5 C 40 C 41 104 F 10 85 Relative Humidity Non Condensing Electromagnetic Compatibility EMC User Information WARNING Medical Electrical Equipment such as the CLX T Light Source needs special precautions regarding Electromagnetic Compatibility EMC and needs to be installed and put into service according to the EMC information provided in the following tables WARNING Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment WARNING The CLX T Light Source should not be used adjacent to or stacked with other equipment If this becomes necessary the CLX T should be observed to verify normal operation in the configuration in which it will be used NOTE The EMC tables and other guidelines below provide information to the customer or user that is essential in determining the suitability of the CLX T Light Source for the Electromagnetic Environment of use and in managing the Electromagnetic Environment of use to permit the CLX T Light Source to perform its intended use without disturbing other Equipment and Systems or non medical electrical equipment Guidance and Manufacturer s Declaration Emissions All Equipment and
14. n off and on standby switch on Power not applied to the unit Ensure the power cord is connected to a live hospital grade receptacle Attenuator closed Rotate attenuator clockwise Blown fuse Replace fuse as indicated in maintenance section No light output and unit Lamp is too old or is defective Replace Install lamp See lamp is making clicking A lamp is not installed replacement section of this user manual sound Reduced light output Attenuator mis positioned Rotate attenuator Aged or defective lamp Replace lamp Headlight or fiber optic light Check or replace faulty component guide is damaged Unit feels warm when Main power switch is on This is normal when main power switch not on Figure 3 is on and stand by switch is off CLX T enclosure is Possible fan failure Return the unit See Return and Repair overheated section of this user manual MAINTENANCE AND CLEANING Maintenance lf the Light Source does not operate properly when connected to a grounded receptacle disconnect the power cord and check the fuse see below Do not attempt to repair the unit if the lamp fails in use Turn off the unit and allow it to cool for at least 15 minutes then try to restart the unit If the lamp Still fails to illuminate it may need to be replaced If you still experience difficulties return the unit to Luxtec or an authorized distributor for evaluation To replace the fuse The fuses for the Light Source are located in the power entry m
15. odule in the rear of the unit Remove the power cord from the unit Using a small flat head screwdriver open fuse access cover then pry out the red plastic fuse holder from the power entry module Check to see if the fuses are blown If necessary replace the fuse s with a new one of the same rating Fuse 3 15A 250VAC 5x20 mm Slo Blo IEC Standard Luxtec part number 601919 After replacing fuse s push the red plastic fuse holder back into the power entry module and snap access cover close Plug the cord back into Light Source and re test the unit Cleaning Allow unit to cool for at least 15 minutes prior to cleaning The Light Source exterior can be cleaned and disinfected using 70 isopropyl alcohol Unplug the power cord before cleaning Allow 5 minutes for alcohol to evaporate before reconnecting to power Use a vacuum cleaner and a soft brush to remove visible dust accumulation from fan and vent holes whenever necessary and always when replacing the lamp sO Lamp Type Xenon Short Arc Lamp Wattage 150 Watts Lamp life 500 Hours Light Source Dimensions 14 6 L x 6 2 W x 5 9 H 370mm L x 157mm W x 150mm H Weight 9 2 lbs 4 2kg Power Input 100 240VAC 50 60 Hz 10 Fuses 2 3 15A 250VAC 5x20 mm Slo Blo IEC Standard Power Consumption 225 Watt nominal AC Power Leakage Leakage current to chassis with ground wire intact less than 100 micro amps Leakage current to chassis with ground wire interrupted less than 500 micro a
16. op cover of the CLX T forward Install the retaining screw Figure 3 using a screwdriver 4 Connect power cord to the back of the CLX T Set main power on off switch to the on position then press on standby switch to turn the unit on 5 Connect a fiber optic cable to verify the unit emits light Forward Lamp module Lamp disposal No disposal restrictions are known for the Xenon lamp User should check and follow any applicable federal state and or local regulations To dispose of Luxtec Xenon lamps simply break the fill tab to release any remaining gas and then dispose of the lamp with no environmental concerns Luxtec lamps are constructed entirely of metal sapphire and ceramic No organic carbon based materials mercury rare earth elements or any other materials with disposal problems are used in the construction of our lamps The Xenon fill gas is an inert gas and is non toxic OPTIONAL FLOOR STAND INSTALLATION Figure 8 CLX T Mounting screws base plate Power cord r i JET map 1 am i lt Handle screw Upper column Lower column Caster base There are four 4 parts to the floor stand assembly See Figure 8 1 Caster base 2 Two piece column 3 Light source base with cable hangers 4 Handle Floor stand assembly instructions 1 Assemble the column Note arrow on the lower column must point up Slide the upper column over the arrow end of the lower
17. quipment It does not cover equipment modified without the written approval of Luxtec subjected to unusual physical or electrical stress altered with non Luxtec parts or damaged during shipment back to Luxtec This warranty is non transferable unless authorized in writing by Luxtec Luxtec reserves the right to make design changes on its products without liability to incorporate said change in Luxtec products previously designed or sold Upon receipt of the product it should be carefully inspected If any defect is discovered Luxtec must be notified immediately This device must be clean of all blood or other organic material prior to returning to Luxtec Luxtec reserves the right to return unrepaired any equipment that is contaminated with blood or other organic material Warranty Service and Repair To obtain service under warranty or return product for repair the customer should contact your local Luxtec distributor or call Luxtec Customer Service at 800 325 8966 US only or 1 508 835 9700 Information contained in this manual is subject to change without notice 15 Luxtec Corporation declares that this product meets the Essential Requirements specified in Annex 1 of the Medical Device Directive MDD LUMTEC Declaration of Conformity Manufacturer Luxtec 99 Hartwell Street West Boylston MA 01583 USA 800 325 8966 USA only 508 835 9700 FAX 308 835 9976 infotajluxtec com Type of Equipment Medical Devi
18. urce e Before any service disconnect the power cord from the main outlet Medical Electrical Equipment such as the CLX T Light Source require special precautions regarding electromagnetic compatibility or EMC These precautions are defined on pages 11 thru 14 of this Users Manual The CLX T must be installed and put into service according to the EMC information provided The leakage current of medical electrical devices can be additive When using the CLX T in combination with other medical electrical devices such as endoscopes and or endoscopy accessories the leakage current should be verified to ensure it continues to meet requirements OVERVIEW Indication for Use This device is designed to supply high intensity white light to a fiber optic cable for illumination of a surgical field or other area of examination or operation The Light Source should never be used in ocular surgery or in a surgical procedure requiring direct illumination of the eye The CLX T delivers white Xenon light The lamp can be easily replaced by the user without special tools The rear panel main power on off rocker switch is located on the back of the CLX T See Figure 1 The front panel push button on standby switch is used to select lamp on or lamp standby See Figure 2 The intensity of the light output is controlled manually by rotating the attenuator ring clockwise to increase intensity counter clockwise to decrease intensity The turret assemb
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