Products For Medicine, Inc
Contents
1. 13 Table of Symbols C CE Mark No Alternating Current Type BF Warning refer to user manual A P 77 Na Off 4 Intensity OOB Refer to user documentation a Hl Mark TN Catalog Number iste Serial Number XL 200 LED User Manual September 2010 Rev 2 WEEE mark 124 Manufactured XL 200 LED User Manual September 2010 Rev 2 General Information and Warnings Caution Federal law restricts this device to sale by or on the order of a physician The PFM light source has been engineered with safety as a priority However the user is cautioned to observe the following 1 2 3 10 11 12 13 14 Read and follow all instructions in this manual Never look directly at the light port when the unit is on your eyesight may be compromised Take care removing fiber optic components or handling the light source some surfaces may be hot Do not use this unit near water or in an area with excessive moisture Do not operate the unit without a fiber optic cable inserted in the port the unit is powerful enough to burn skin if within contact of the opening Do not place flammable materials near the unit Do not defeat the safety purpose of the 3 prong grounded plug Use only the approved power cord supplied with the unit Route cord so it will not be pinched severed or walked upon Do2. XL 200 LED User Manual September 2010 Rev 2 9 Product Specifications Improvements may result in specification or feature changes without notice Physical Dimensions Overall Height Overall Width Overall Depth Unit Weight Adapter Receptacle Adapter Power Requirements Power Consumption Fuse Classification Electrical Safety Electromagnetic Compatibility Recommended Conditions e Operating 5 0 121 mm 7 625 205 mm 7 75 219 mm 13 5165 4 8 kg including cord 1 25 4mm OD 5 different types Storz ACMI Wolf Olympus Pilling 100 240 VAC 50 60Hz 65 Watts 65VA 2A Type F Quick Blow Type BF Class II IEC EN 60601 1 2006 UL 60601 1 2003 CSA C22 2 No 601 1 1990 R2005 IEC 60601 1 2 2007 o Temperature 5 C to 40 C o Humidity 1096 to 8596 Relative Humidity Non Condensing e Storage o Temperature 5 C to 50 C o Humidity 1096 to 8596 Relative Humidity Non Condensing XL 200 LED User Manual September 2010 Rev 2 10 Customer Support PFM maintains support services to assist you Please contact your representative for support You may also contact us directly by phone facsimile mail or e mail at PFM Customer Service Department 1201 E BALL RD ANAHEIM CA 92805 USA 800 333 3087 toll free within US and Canada 001 714 991 8222 Monday Friday 8AM 4 PST USA WWW PRODUCTSFORMEDICINE COM Be sure to have your part number and serial number available as well as a com
3. the user s responsibility to verify using the XL 200 LED with or near other equipment will not adversely affect the performance of either unit Use of portable or other Radio Frequency RF telecommunications equipment may affect the performance of the XL 200 LED light source Do not touch any interconnections between electrical components and the patient at the same time These include connections for video data control or power Use only PFM supplied components and or cables with the XL 200 LED light source Use of other components and or cables may adversely affect electrical emissions or immunity XL 200 LED User Manual September 2010 Rev 2 5 Operation The XL 200 LED light source can be used around the world operating with line voltages in the range 100 to 240 V AC and 50 or 60 cycle operation BONES B 9 Make sure the power switch 2 on the front panel is in the off position Plug the power cord into the power connector D in the rear of the light source Plug the other end into a power source Inspect the optical element 5 to verify the element is clean Clean per maintenance instructions if necessary Insert the appropriate adapter into bezel aligning the through hole in the adapter with the thumbscrew in the top of the bezel Tighten the screw to capture the adapter but not too far as to obstruct the opening for the fiber optic component Insert the selected fiber optic component 7 Make sure the
4. the unit dry thoroughly before using Periodically dust should be removed from the unit using a vacuum Pay special attention to the air vents at the rear of the unit in the front around the bezel and on the bottom of the main housing The optical element in the front light port should be inspected before use to verify there is no contamination If contaminated clean with soft cloth or swab and alcohol Allow alcohol to dry completely before using light source Use of Filters There is no filter drawer or filter receptacle on the XL 200 LED Troubleshooting If you are unsuccessful at resolving the following conditions contact PFM for a Return Material Authorization RMA Do not attempt to repair the light source Tampering with the electronics will void the warranty Fan operates but unit has low light output Insure the fiber optic component is clean undamaged and fully seated Check the intensity setting Make sure there are no obstructions blocking the cooling vents Verify optical element in light port is clear Verify light guide is correct size The output size of the light source is 5 0mm Smaller diameter light guides will work but will have lower light output Fan operates but output is intermittent every few minutes unit turns off and turns on e The light source is running too hot A thermal cutoff protects the circuitry from heat damage e Possible Causes o Inadequate Air Flow Check air intakes and ex
5. 00 LED light source requires continued operation during power mains interruption the light source should be powered from an lt 5 Ut lt 5 Ut gt 95 dip in gt 95 dip in uninterruptable power for5s for5s supply or battery Power frequency 3 A m 3 A m Power frequency 50 60 Hz magnetic field IEC 61000 4 8 magnetic field should be at levels characteristic of a typical location in a typical commercial or hospital environment Note Ur is the mains voltage before application of the test level XL 200 LED User Manual September 2010 Rev 2 15 Table 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity The XL 200 LED Light Source is intended for use in the electromagnetic environment specified below The user of the XL 200 LED Light Source should ensure that the device is used in such an environment Immunity Test IEC 60601 Test Compliance Electromagnetic Environment Guidance Level Level Portable and mobile RF communications equipment should be used no closer to the XL 200 LED light source than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 1 2N IEC 61000 4 6 150 kHz to 80MHz Radiated RF 3 V m 3 Vrms d 1 2N 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 3V 800 MHz to 2 5 GHz Where
6. DS are bin selected for color temperature and power and should not vary by more than 5 Finally heat plays a critical role in LED power and life Make sure all vents are free from obstruction Make sure the fan is running and the unit is not in a restrictive enclosure If the LED gets too hot you could experience a dramatic decline in output and the unit s temperature monitor may disrupt power to the lamp Maintenance LED Replacement These chip arrays should last on average 50000 hr If a chip requires replacement contact the factory for service Fuse Replacement Under normal use the fuse should not require replacement The purpose of the fuse is to protect the electronics from failure due to inrush Should it become necessary to change the fuse replace with the same type 2amp quick blow to insure long life and best performance Cleaning The housing has a durable finish that should retain its original luster for many years Cleaning the exposed areas with a commercial glass cleaner or common household detergent will help maintain the finish XL 200 LED User Manual September 2010 Rev 2 7 Unplug and remove the power cord from the IEC connector on the back of the unit Wipe the exposed areas of the housing with a soft cloth or paper towel moistened with general purpose cleaner CAUTION Do not use excess water treated cloth harsh cleaning agents or sprays Use cleaning fluid sparingly If fluid spills into the interior let
7. LIGHT SOURCE TO WHICH THIS DECLARATION RELATES ARE IN CONFORMITY WITH THE DIRECTIVE AND STANDARDS LISTED BELOW MEDICAL DEVICE DIRECTIVE 93 42 IEC 60601 1 UL 60601 1 CSA C22 2 NO 601 1 IEC 60601 1 2 XL 200 LED User Manual September 2010 Rev 2 18 Products For Medicine Inc 1201 E Ball Rd H Anaheim CA 92805 USA 800 333 3087 toll free within US and Canada 001 714 991 8222 international Monday Friday 8AM 4PM PST USA www productsformedicine com XL 200 LED OWNERS MANUAL XL 200 LED User Manual September 2010 Rev 2 19
8. P is the maximum output power rating of the transmitter in watts w according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol a Note 1 At 80MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by adsorption and reflection from structures objects and people a While medical equipment is normally compliant with IEC 60601 1 2 emission required field strength from fixed transmitters such as cell phone towers or terrestrial radio and TV transmitters cannot be predicted Therefore an electromagnetic site survey should be considered to verify compliance with the electromagnetic environment required above If the measured environment exceeds that recommended the user should monitor the XL 200 LED for abnormal performance b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m XL 200 LED User Manual September 2010 Rev 2 16 Table 4 Recommended Separation Distances between Portable and Mobile RF Communication Equipment and the XL 200 LED light source The XL 200 LED light source is intended for use i
9. Products For Medicine Inc XL 200 LED Features Specification and Operation Instructions Fiber Optic LED Light Source Table of Contents Table of cn ees ene d onto ek 2 General Information and Warnings rrnnnnnnnnnnnvnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnen 4 Product e 4 Installation Guidelines cerent nentn tran summa suu cnra auae 4 Indications for emer rr 5 Use with other equipment uoces ded rd dius ene Qnid Qa idi Qoncdi di dex cv duh 5 Operation M n 6 Lamp Intensity 7 prp e 7 LED Replacement sestara 7 Fuse Beplacement tp Gre teet ette AS AE S A eee 7 61 1111 EE EE E E E E 7 Of PINMCES eieo S EE els eens et ES 8 Troubleshooting E sen Se se esate sete eats ened eo ened a iaa anade 8 Product Specifications cure natant tu tuna ttn aka nhi du a benkene anna ing GE 10 Customer SUpport X 11 Service RNA Pl idsccicoikdu nido ode dann Conr fa ou lw ux it aASES 11 Warranty seen 12 EET MC
10. c Immunity The XL 200 LED Light Source is intended for use in the electromagnetic environment specified below The user of the XL 200 LED Light Source should ensure that the device is used in such an environment Immunity Test 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 The XL 200 LED Light Source is suitable for use in a dry environment Electrical fast 2 kV for power 2 kV for power supply lines Mains power quality should be that of a transient burst supply lines 1 kV for input output lines typical commercial or IEC 61000 4 4 1 kV for hospital environment input output lines Surge 1 kV differential 1 kV differential mode Mains power quality mode should be that of a IEC 61000 4 5 2 kV common mode typical commercial or 2 kV common mode hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 Ut gt 95 dip in for 0 5 cycle 40 60 dip for 5 cycles 70 Ur 30 dip for 25 cycles lt 5 Ut gt 95 dip in Ur for 0 5 cycle 40 U1 60 dip in for 5 cycles 70 U1 30 dip in for 25 cycles Mains power quality should be that of a typical commercial or hospital environment If the user of the XL 2
11. captive thumbscrew on the bezel goes through the adapter and locks the input of the fiber optic component in place Depress the power switch 2 to the ON position Adjust the light intensity with the intensity control knob 3 to desired setting 10 To turn the unit off press the power switch to the off position High temperature indicator Power Switch Intensity control Bezel Accepts adapter not shown Optical Element ZS lt lt 4 DN 8 A Power rating G AI z Ct TES B Fan C Fuse D Power connector XL 200 LED User Manual September 2010 Rev 2 6 Intensity regulation The intensity control must be turned to the 9 o clock position before you will notice any output This is normal and does not affect performance Lamp Intensity Just like halogen lamps LEDs degrade over their lifetime most by an average of 15 However the difference between the two types is lifetime Instead of degrading 1596 over 200 hrs LED will degrade 15 over 50 000 hours with the change of intensity over time barely noticeable Furthermore LED arrays are not created equal As proven by independent research LED arrays like their Halogen counterpart may vary 20 in maximum intensity depending on the batch Additionally color temperature can vary from unit to unit This is considered normal and is the result of the manufacturing process for LED chips PFM LE
12. g by an officer of PFM or separate published warranty is cited for specific product groups The warranty is void if e We determine the product has been subjected to neglect or misuse or has been installed following procedures not in accordance with our instruction manual e Unauthorized repairs or modifications have occurred e The warranty seal has been broken or the serial number label has been altered Our obligation is limited to repair or replacement FOB ANAHEIM CA We will not be held responsible for consequential damages transportation installation adjustment or other expenses arising in connection with our products or parts This warranty is in lieu of all other statements or guaranties written or implied by PFM or our authorized representatives XL 200 LED User Manual September 2010 Rev 2 12 Liability Any warranty implied under State Law shall be limited to one year from original delivery to original purchaser Specifically excluded from PFM liability is damage resulting from acts of any deity malicious mischief vandalism riots wars improper installation or neglect in the operation or maintenance of the unit or misunderstanding of the properties of the unit Under no circumstances shall PFM be obligated for consequential or other damages of any kind or description losses or expenses in connection with or by reason of the use of or inability to use this unit for any reason The stated warranty provides the purchaser w
13. haust areas for dust or dirt accumulation Make sure minimum clearances are maintained See installation guidelines for clearance information Move the light source to a cooler ventilated location NEVER enclose the light source without adequate ventilation o Fan failure Fan will be visible through rear vent Verify fan is rotating If fan is not rotating return unit to manufacturer for servicing XL 200 LED User Manual September 2010 Rev 2 8 Fan operates light is not on e The chip may have failed Contact the factory Fan does not operate light is on e Return unit to manufacturer for servicing Fan and light are not working Make sure the power cord is inserted completely into the IEC connector and also into the power source e Check the power cord for damage e Check the fuse e Check the outlet Fiber input is burning e Check the fiber type it may be plastic and susceptible to burning All standard PFM fiber optic light guides are made with glass fibers e Contamination on fiber o Verify fiber face is clean e Contamination on light source optical element o Verify optical element is clean e Light guide is damaged o Replace light guide PFM offers a repair service and replacement light guides Contact PFM for more information Ask your light guide supplier about the epoxy used to manufacture the fiber optic input some epoxy types cannot withstand the high photonic energy developed by this light source
14. ith specific legal rights and there may be additional rights which vary from State to State Some states for example do not allow exclusion of consequential damage XL 200 LED User Manual September 2010 Rev 2 13 Table 1 Guidance and Manufacturer s Declaration Electromagnetic Emissions The XL 200 LED Light Source is intended for use in the electromagnetic environment specified below The user of the XL 200 LED Light Source should ensure that the device is used in such an environment IEC 61000 3 3 Emission Test Compliance Electromagnetic Environment Guidance RF emissions The XL 200 LED Light Source uses RF energy only for its internal CISPR 11 Group 1 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 B TA The XL 200 LED Light Source is suitable for use in all Harmonic emission Class A establishments including domestic establishments and those IEC 61000 3 2 4 directly connected to public low voltage power supply network that supplies buildings used for domestic purposes Voltage fluctuations Flicker emissions Complies Essential Performance The XL 200 LED Light Source is safe and effective when used in the electromagnetic environment specified in Tables 2 through 4 XL 200 LED User Manual September 2010 Rev 2 14 Table 2 Guidance and Manufacturer s Declaration Electromagneti
15. m Do not block any air vents 2 Proper ventilation must be provided at all times Failure to do so may cause intermittent operation and or failure of the electronics 3 A Avoid areas of excessive vibration 4 Operate the light source only in an environment where people do not require protective equipment 5 CAUTION Dust accumulation will restrict air flow which can damage the unit See Cleaning Section for recommendations Indications for Use The XL 200 LED light source is intended to provide white light to an accessory fiber optic light guide to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy orthopedic surgery and for use with a surgical headlight for general surgical or examination procedures Use with other equipment Any equipment connected to the XL 200 LED light source must be certified to IEC60601 1 or other IEC ISO standards appropriate to the equipment and application The user must not compromise the performance and safety requirements of the XL 200 LED light source when used with or near other equipment The light source shall not be immediately adjacent to beneath or above other electrical equipment All medical electrical equipment generates and receives electromagnetic and radio frequency interference RFI from other equipment Use of the XL 200 LED near other equipment may adversely affect the function the light source or other equipment It is
16. n an electromagnetic environment in which radiated RF disturbances are controlled The user of the XL 200 LED light source can help prevent interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the XL 200 LED light source as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum m output power of aa 150 kHz to 80 MHz 80MHz to 800 MHz 800 MHz to 2 5 GHz d 12N P d 1 2N P d 1 2N 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 reflection from structures objects and people For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined 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 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by adsorption and XL 200 LED User Manual September 2010 Rev 2 17 DECLARATION OF CONFORMITY WE PRODUCTS FOR MEDICINE DECLARE UNDER OUR SOLE RESPONSIBILITY THAT THE FOLLOWING PRODUCT NUMBERS LISTED XL 200 LED LED
17. not defeat the purpose of the fuse Replace only with the fuse type described in the manual and as marked on the unit Do not remove the cover High voltage is present internally Keep all safety and operating instructions for future reference Do not block ventilation openings on this unit Do not impede airflow If you wish to clean the unit disconnect the power and use only standard detergent type cleaners do not use solvents or petroleum distillates Never spill liquid on the unit Allow the unit to cool before cleaning Do not service the unit beyond what is described in this manual Attempting repair of electronic or logic circuits without prior written approval of PFM will void the warranty Should the light source fail at any time return it to an authorized PFM service center For a Return Material Authorization contact the Customer Service department 800 333 3087 Product Description The PFM light source family was designed to be backward compatible with previous PFM fiber optic accessories Furthermore with the proper adapter the light source can accept all major brands of fiber optic component Please note The XL 200 LED uses a unique adapter configuration Use only PFM supplied adapters Installation Guidelines To insure proper operation of the light source the following conditions must be met XL 200 LED User Manual September 2010 Rev 2 4 Minimum Clearance Rear Sides and Top 1 5 37 mm 5 12 5 m
18. plete description of the problem or situation for the quickest most accurate assistance Service RMA Policy There are no user serviceable parts in this product Service required for any reason must be performed by PFM or an authorized service representative All service outside warranty will be performed with purchaser s approval and charged according to normal service charges in effect at the time To return any item whether for warranty repair or chargeable servicing an RMA number Return Material Authorization must be obtained from PFM This number must be clearly visible on the shipping label All shipping must be prepaid If the light source was used in a biohazard environment you may also be asked to supply a certification stipulating the conditions of service including a list of materials the light source may have been exposed to This unit must be clean and decontaminated before shipment PFM reserves the right to return any product contaminated with blood or other organic material without repair PFM guarantees all warranty repairs will be completed within two weeks of receipt All units will ship prepaid using our shipping method of choice Alternate shipping methods will be shipped freight collect XL 200 LED User Manual September 2010 Rev 2 11 Warranty PFM warrants its family of light sources to be free from defects in material and workmanship for a period of two years from date of shipment unless stated otherwise in a
19. specific separate published warranty If any PFM product is found to have defects in material or workmanship the purchaser should notify PFM promptly and request an RMA number After an RMA number is assigned purchaser may return defective products prepaid to the originating PFM facility PFM at its sole discretion will repair or replace PFM products found to be defective and return said products prepaid PFM s correction of any defects by the grant of credit repair or replacement shall constitute fulfillment of all obligations and liability to the purchaser hereunder PFM is not responsible for damage to product caused by abuse or neglect unauthorized installation maintenance use repair or adjustment Any of the aforementioned actions shall make this warranty null and void and shall relieve PFM from any further responsibility hereunder PFM shall not be liable for any incidental special or consequential damages in any claim action suit or preceding arising under this warranty or any other part of the agreement of sale between PFM and the purchaser nor shall there be any liability hereunder for labor claims loss of profits or good will repairs or other expenses incidental to replacement The foregoing warranty is in lieu of all other representations and warranties expressed or implied written or oral including warranties of merchantability or fitness of the goods for a particular purpose unless exception is offered in writin
Download Pdf Manuals
Related Search