Product user manual
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1. Portable LED Light Source PLS Operator s Manual Manufactured by Optim LLC 64 Technology Park Road Sturbridge MA 01566 1253 USA USA Tel 1 800 225 7486 Tel 1 508 347 5100 Fax 1 508 347 2380 www optim llc com sales optim llc com Table of Contents Page LE aikoo 0 lors 0 a ee ee 3 MACANO eree E E E noe iavansanenectsinusane pend A A A AA S 3 Fe IOS es cae ae na ioscan E E AA E e EA EE E A EE E A 3 2 Light Source Description Specifications amp ACCESSOFICS cccccccseeeeeeeeeeeeeeeeeeeaeeeeees 4 Light Source Control Body Diagram and Descriptions cccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeaaneeeeeeeas 4 BS CINCO INS exeateeedaoceateavsinestefeicabaapaids sete noes iaaah iana aes ARa DEE AA Or aai aaa EADAE 5 ACCESSOLIES TEEPEE 5 3 Light Source Function and Operation cccccccccccccccceceeeeeeeeeeeeeessaeaeeeeeeeeeessaeaaeeeeeeeeeseaas 6 Light Source Preparation cccccececccccececeseeseeeeeeeeeeeeeeeseeeeeeeesseeeeeseeeeeessseeaeeeeeeeesssaeeaeeseeeeseaaas 6 Light Source Operation o criicc oe exe ccdenecensnaienieedeneiieis naeededalnatnncbicenssndennetidcsinapaddyieweneasedeasbactnewerasesees 6 Battery ANd CharQer ccccccccccsssssccceceeeeceeeceeseceeeceeaeeeeeeeeeaeeeessseaeceesseaaeeceesssaaseeeeseegeeeessaas 7 4 Care amp Maintenance ais sce cence snscctssier cnc dnceaeslvbcdasdeceenesis acdtsaviedeusasvdxeevanscasesns acdtsecededtenstaesstaoweds 9 M2. Avoid storing or using the light source in areas of heavy traffic where the light source may sustain physical damage e Avoid immersing the light source for periods of time greater than recommended by the disinfectant manufacturer Prolonged immersion may damage the exterior of the light source and could result in fluid invasion into the light source e Do not attempt to disassemble the light source in any way There are no user serviceable parts and disassembly will void all warranties Avoid looking directly into the light source when it is on e Prior to use check the outer surface of the light source endoscope and any endoscopically used accessories for rough surfaces sharp edges or protrusion that may cause a safety hazard 2 Light Source Description Specifications amp Accessories Light Source Control Body Diagram and Descriptions Light Guide Post Adapter Nut Light Intensity Switch Light Intensity Indicator PORTABLE LE Figure 1 Portable Light Source Diagram Adapter Nut The adapter nut allows the portable light source to attach to the user s endoscope Rotate the nut clockwise to attach the light source to an endoscope and counterclockwise to remove the light source The standard configuration of the Optim PLS is with an Adapter Nut that threads onto the standard universal light guide post s Storz adapter thread Light Intensity Switch The light intensity switch controls the on off and intensity functions
3. by passage through a 0 2 micron filter or otherwise treated by a method documented to improve the microbiological quality of water ASTM F 1518 4 A final rinse using 70 isopropyl alcohol solution can be used to speed the drying process and reduce the numbers of any organisms present as a result of rinsing with potable water 5 Dry the exterior of the light source with a soft clean towel Ill Drying the Light Source If the PLS becomes wet either from reprocessing or cleaning fluids thoroughly dry the exterior immediately Rinsing with isopropyl alcohol followed by drying with a compressed gas such as compressed air or commercial compressed gas canisters is highly recommended to reduce contamination of the glass light guide and reduce the possibility of oxidation of the materials used in the construction of the light source WARNING Do not permit the light source to remain in cleaning or disinfectant solutions longer than the manufacturer s recommended treatment time Do not permit the light source to remain in any liquids for prolonged periods of time In addition if the PLS becomes wet thoroughly dry the battery cap seal around the o ring with compressed gas or by thoroughly wiping any excess liquid from this area prior to removing the battery cap This will prevent any trapped fluid from inadvertently entering the battery compartment and exposing the electronics to fluids WARNING Ensure there is no trapped liquid between
4. environments specified below The customer or user of the PLS should ensure that it is used in such an environment Guidance and Manufacturer s Declaration Emissions The PLS uses RF energy only for its internal function Therefore its RF RF Emissions Group 1 emissions are very low and are not likely to cause any interference in nearby CISPR 11 electronic equipment RF Emissions Class B CISPR 11 The PLS is suitable for use in all establishments including domestic and those Harmonics directly connected to the public low voltage power supply network that supplies IEC 61000 3 2 buildings used for domestic purposes Flicker IEC 61000 3 3 Guidance and Manufacturer s Declaration Immunity Immunity Test EN IEC 60601 Compliance Level Electromagnetic Test Level Environment Guidance ESD 6kV Contact 6kV Contact Floors should be wood concrete EN IEC 61000 4 2 8kV Air 8kV Air or ceramic tile If floors are synthetic the RH should be at least 30 EN IEC 61000 4 4 1kV I Os battery and has no I Os EN IEC 61000 4 5 2kV Common battery and has no I Os Voltage gt 95 Dip for 0 5 cycle N A PLS is powered by internal Dips Dropout 60 Dip for 5 Cycles battery and has no I Os EN IEC 61000 4 11 30 Dip for 25 Cycles gt 95 Dip for 5 Seconds Power Frequency Power frequency magnetic fields 50 60Hz should be that of a typical Magnetic Field commercial or hospital EN IEC 61000 4 8 environment 12 Guidance and M
5. of the portable light source Moving the lever towards the wider end of the intensity indicator will turn the light source on and increases the light intensity moving the lever towards the narrower end of the intensity indicator decreases the light intensity and turns the light source off Battery Cap The battery cap seals the battery and electronics within the control body Specifications Parameter Body Diameter Overall Length Weight with battery Battery Life at Full LED Power Battery Charge Time Battery Type Lithium lon 3 6V 7OOMAHr minimum Power Source Mode of Operation Continuous Safe Operating Ambient Temperature Range Safe Storage and Transport Temperature Range Safe Operating Storage and Transport Relative 0 95 RH Humidity Range Accessories Portable Light Source Kit 3 Light Source Function and Operation Light Source Preparation e Before use the light source should be reprocessed Please refer to the Care amp Maintenance Section of this manual for proper reprocessing protocol Light Source Operation Figure 2 Attaching the Portable Light Source to a rigid scope e Hold the light source so that the main body fits comfortably in one hand allowing easy manipulation of the adapter nut with the thumb and forefinger e Tighten the adapter nut onto the endoscope light post by turning clockwise Do not thread the light source by turning the light source body only rotate the adapter nut
6. EEC Annex VII USA TEL 1 800 225 7486 TEL 1 508 347 5100 FAX 1 508 347 2380 Part No NO014784D DCN No 10514 January 2015 16
7. NOTE The endoscope may have included adapters that are supplied attached to the light post prior to shipping unthread adapters prior to attaching the PLS Light Intensity ____ gt _ gt Switch Intensity Indicator Figure 3 Intensity Control Switch e Turn on the light source by rotating the light intensity switch towards the wider end of the intensity indicator Adjust the brightness to the desired level by rotating the intensity switch further e Atthe completion of use turn the light source off by rotating the light intensity switch towards the narrower end of the intensity indicator e Remove the light source from the endoscope by rotating the adapter nut counterclockwise e Avoid leaving the light source on for extended periods of time when not in use as this will drain the battery unnecessarily Battery and Charger A Li ion Battery Battery Cap O Ring Figure 4 Removing the battery cap and inserting and removing the Li lon Battery The PLS s internal LED light source operates on a single Lithium ion battery and provides approximately 45 minutes of continuous operation when a new battery is fully charged To insert a new battery align the battery with the cutout in the battery compartment making sure the end of the battery with the two gold electrical contacts is inserted into the battery compartment first Once a charged battery is inserted into the light source body replace the batter cap by screwing the cap cl
8. anufacturer s Declaration Emissions Immunity Test EN IEC 60601 Compliance Level Electromagnetic Environment Test Level Guidance Conducted RF 3Vrms N A PLS powered by internal Portable and mobile EN IEC 61000 4 6 150kHz to 80MHz battery no I Os communications equipment should be separated from the PLS by no Radiated RF 3Vrms E1 3V m less than the distances calculated EN IEC 61000 4 3 80MHz to 2 5GHz or listed below D 3 5 E1 VP 80 to 800MHz D 7 E1 VP 800MHz to 2 5GHz Where P is the max power 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 than the compliance levels E1 Interference may occur in the vicinity of equipment containing a transmitter Recommended Separation Distances between portable and mobile RF Communications Equipment and the PLS Equipment and Systems that are NOT Life supporting The PLS is intended for use in the electromagnetic environment in which radiated disturbances are controlled The customer or user of the PLS can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the PLS as recommended below according to the maximum output power of the communications equipment Max Output Separation m Separation m Separation m Power 150kHz to 80MHz 80 to 800MHz 800MHz to 2 5GHz W
9. atts D 3 5 V1 VP D 3 5 V1 VP D 3 5 V1 VP Note 1 The PLS is internally battery powered and has no I Os Conducted RF Immunity testing does not apply resulting in no separation data from 150kHz to 80MHz 13 7 Repair Service Customer Service The PLS is serviced at Optim LLC s manufacturing facilities in Sturbridge MA USA Use the following procedure to expedite returned goods for evaluation repair or replacement 1 Telephone Optim LLC at 1 800 225 7486 or 1 508 347 5100 or complete the online RMA Request Form on our website www optim llc com rma request 2 Provide a detailed description of the problem and include the serial number 3 If the light source needs to be sent to Optim a Returned Material Authorization number will be issued 4 The light source should then be returned to the address below for repair or replacement 5 Include a copy of the RMA inside the package 6 Have RMA number visible on the outside of the package Returning Goods to Optim LLC Ship the PLS in the carrying case and within a corrugated box to prevent damage during shipment Ship to Optim LLC 64 Technology Park Road Sturbridge MA 01566 1253 USA Attention Customer Service RMA ATTENTION If the light source has been used in a clinical setting the light source must be reprocessed according to procedures outlined in the Care amp Maintenance section of this manual before shipment to Optim LLC Upon evaluation the cust
10. commends the light source be pre cleaned immediately after the device has become contaminated This will prevent patient material from adhering to the light source Dried material is difficult to remove and can render the disinfection or sterilization process ineffective Gently wipe all debris from the exterior surfaces using a soft lint free cloth and water to which you have added a low sudsing detergent diluted in accordance with the detergent manufacturer s instructions Enzymatic Cleaning and Rinsing 1 Filla basin with a freshly made solution of water and a low sudsing detergent diluted in accordance with the detergent manufacturer s instructions 2 Immerse the light source Wash all debris from the exterior of the light source by gently brushing and wiping the instrument while submerged in the detergent solution 3 Rinse the light source in clean water 4 Wipe dry the exterior of the light source with a soft clean cloth High Level Disinfection with CIDEX OPA 0 55 ortho Phthalaldehyde Solution 1 Prepare the disinfectant solution in accordance with the solution manufacturer s label 2 Completely immerse the light source in the disinfectant solution for the recommended time and temperature as indicated on the label of the disinfectant 3 Thoroughly rinse the exterior of the light source with large amounts of clean water NOTE It is suggested that all rinsing after disinfection should be done with water that has been filtered
11. ethods of Light Source REProCeSSIN ccccccsseseeeeceeeeeeeeeeseeseceeeeeseeeeeeessaeeeeeeeeaeeeeeeeeeas 9 Il Light Source Reprocessing Protocoll cccccccccseescceeeeeeeeeeeeeeeeeceeeseaeeeeeeesseeeeeeeeeeegeeeeeeeas 9 1 Pre Cleaning eee eee ees 9 2 Enzymatic Cleaning ANd RINSING ccccccccccesseseceeeceeeeeeeeeeeeaeeeeeeeeeeeeeeessaaeeeesensaees 9 3 High Level Disinfection cccccseseecccesececceeseeecseeeeceeuseecseaseeessageeeeseseesssaseeessageees 10 Il Drying the Light SOUlCC seicccccencvesseucsuasnsencdenne panndnce2sdansanecdacnstdeiensbhocdedewsbedeneseaidanestdedesents 10 5 TOUDI SOO WIN nanen E E A i 11 6 Agency Compliance Statements and Guidance Tables cccccccccececeeeeeeeeeeeeeeeeees 12 Guidance and Manufacturer s Declaration EMISSIONS ccccsesceeceeeeeeeeeeeeeeeeeseeeeaeeeeeens 12 Guidance and Manufacturer s Declaration Immunity cccseeeeeeeeceeeeeeeeeeaeeeeeeeeesaeeeeees 12 Guidance and Manufacturer s Declaration EMISSIONS ccccseeeeeceeeeeeeeeeeeeeeeeeeeeeaeeeeens 13 Recommended Separation Distance between Portable and Mobile RF Communications EgUPMEN ieee ceciecacee ste us anaie a a e ii 13 Fo Ca SCIVO o E E vateanaeene 14 8 Waray ee a E E E E i sets sua sctisaten i alenantiansios 15 9 Symbol Descriptions 5 sassisccd tacdcesindeisnasnadiewsiecsadetinenitd dined aditeidenmasiiesniseaseie cid naiasdda
12. ndsecivadinienecaaibenhadieddsncetidentes 15 10 RegulaloTy eese E E E E E ai 16 11 Vendor Information 0 cece cece ce eeeeeeeeeaeeeeeeeeeaseeceeesseeeseeeesseaaeeeeesseaeeeeessaaseeeeessaaeeees 16 WARNING This device is not supplied sterile Clean and disinfect the device prior to use employing the procedure listed in this manual WARNING This equipment is not suitable for use in the presence of flammable mixtures WARNING the following methods of sterilization and disinfection will result in damage to the light source and should not be used Ethylene Oxide autoclave ultrasonic chlorides formaldehyde and hydrogen peroxide WARNING In order to avoid potential safety hazards the user of this device should consult the manuals of all Medical Electrical Equipment used in conjunction with this device If this device is used with High Frequency Equipment the attached endoscope should be medically approved for use with High Frequency Equipment and the user should consult the manuals of all devices for safe operating voltage levels This device is a TYPE BF Applied Part It should only be connected to medically approved Type BF endoscopes that conform to IEC60601 1 and IEC60601 2 18 IPX7 This equipment is rated IPX7 This device is covered under US Patents For a complete listing visit our website at www optim llc com patents 1 Introduction Indications The Optim Portable Light Source PLS is intended to pro
13. ntinue past 30 minutes Or turn the light source off for a few minutes to permit adequate cool down of the light source body ACMI Snap Ring Groove Wolf Adapter Thread NN Storz Adapter Thread SS Figure 7 Standard Universal Light Guide Post The standard light guide post consists of a snap ring groove for an ACMI fitting connection a Wolf adapter thread and a Storz adapter thread The PLS attaches to the Storz adapter thread Wolf ACMI providing a secure connection between the light source and light guide within the scope If an adapter sleeve see Figure 7 below is on the light guide post it must be removed prior to connecting the PLS to the Storz adapter thread Figure 8 Standard Universal Light Guide Post left Post with Wolf Adapter center and Post with Storz Adapter right 11 6 Agency Compliance Statements and Guidance Tables Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this section Portable and Mobile RF communications Equipment can affect Medical Electrical Equipment WARNING The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the equipment or system should be observed to verify normal operation in the configuration in which it will be used The PLS is intended for use in the electromagnetic
14. ockwise until a tight seal is made To remove the battery simply unscrew the battery cap and turn the light source upright until the battery falls out Please take care not to let the battery fall to the floor or onto a hard object which could damage the battery CAUTION e Do not incinerate the battery e Do not expose the battery to high temperatures above 122 F 50 C e Do not disassemble the battery e Do not short circuit the battery WARNING The battery should be removed if the equipment is not likely to be used for some time DC in Jack eS AC Adapter N Battery Contacts Status Indicator Charger Indicator Figure 5 Battery Charger and End Views of Battery To charge a battery e First plug the AC adapter into a wall outlet e Connect the AC power adapter to the DC IN jack located at the back of the charger The STATUS indicator will be solid RED when the charger is ready and the CHARGE indicator will be flashing GREEN when the charger is waiting for a battery to charge e Slide the battery into the charger making sure the end of the battery with the two gold electrical contacts is inserted into the charger first The CHARGE indicator will turn RED when the battery is charging e The CHARGE indicator will alternately flash RED and GREEN when the battery has been charged to over 90 e When the battery is fully charged the CHARGE indicator will turn solid green e After the batte
15. omer will be contacted and advised of the findings and estimated repair cost Repairs will not begin until authorization or a purchase order is issued indicating the approval of charges 14 8 Warranty The Optim LLC Portable Light Source PLS is warranted to be free from defects in materials and workmanship for a period of one 1 year from the date of purchase All non warranty repairs will be warranted to be free from defects in materials and workmanship for a period of ninety 90 days from the date of the invoice Accidental damage and damage resulting from misuse abuse excessive sterilization disinfection and sterilization methods not approved by Optim LLC as well as fluid invasion and normal wear and tear will be subject to prevailing repair charges Disassembly alteration or repair performed by any person not authorized by Optim LLC will result in immediate loss of warranty THE ABOVE WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES EITHER EXPRESS OR IMPLIED INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE Suitability for use of the medical device for any surgical procedure shall be determined by the user Optim LLC shall not be liable for incidental or consequential damages of any kind All shipping charges to and from Optim s facility is the responsibility of the customer 9 Symbol Descriptions Attention Read Operating Manual for Warnings Cautions and Instructions for Use This equi
16. oval of all adherent visible soil i e blood protein substances and other debris from the surface crevices and joints of the light source Use caution when cleaning and disinfecting your light source some methods may be harmful to the light source and could result in extensive damage Manual cleaning is the recommended method for cleaning your precision light source To be effective cleaning agents must assist in the removal of residual organic debris without damaging the device No single cleaning agent removes all types of debris or is safe to use with every type of reusable device Certain cleaning agents may damage the device s materials Cleaning agents should be used in the correct dilution concentration and at the correct temperature in accordance with the cleaning agent manufacturer s directions Please contact Optim LLC s Service Center at 1 800 225 7486 or 1 508 347 5100 to verify the compatibility of a cleaning method not listed below under Section II Light Source Reprocessing Protocol WARNING Ensure that the battery cap is fully tightened on the o ring seal to prevent liquid intrusion into the battery compartment WARNING Remove the battery prior to immersing into solutions Il Light Source Reprocessing Protocol 1 Pre Cleaning 2 Enzymatic Cleaning and Rinsing Enzol Fast Acting Enzymatic Cleaner or equivalent 3 High Level Disinfection with CIDEX OPA 0 55 ortho Phthalaldehyde Solution Pre Cleaning Optim re
17. pment is rated IPX7 and is protected against the effect of immersion between 15cm and 1m S N This symbol indicates the products Serial Number This symbol indicates that this product is a Type BF applied part Light intensity indicator A Light intensity switch a In the European Union this symbol indicates that when the end user wishes to discard this product it must be sent to separate collection facilities for recovery and recycling By separating this product from other household type waste the volume of waste sent to incinerators or land fills will be reduced and natural resources will thus be conserved 15 10 Regulatory The PLS has been tested to and found in conformance with the following standards IEC 60601 1 IEC 60601 1 1 IEC 60601 2 18 CSA C22 2 601 1 1 European Medical Device Directive 93 42 EEC 2007 47 EC 21 09 2007 The CE mark on this product indicates that it conforms with the requirements of the Authorized Representative Scanlan Group B V Postbus 75664 1118 ZS Schiphol Triport The Netherlands Telephone 31 0 20 653 0553 5 209 P PIN EA Twm F Cr nde Intertek tertek 11 Vendor Information Manufactured and Serviced by Optim LLC 64 Technology Park Road Sturbridge MA 01566 1253 USA Website www optim llc com Sales amp Service Email sales optim llc com ISO 9001 2008 ISO 13485 2003 IS014971 2007 FDA CGMP 820 CDN MDR CMDCAS MDD 93 42
18. ry has been fully charged slide the battery out of the charger and unplug the AC adapter for the charger CAUTION e Do not expose the charger to fire water or moisture e To avoid electrical shock do not disassemble the charger e No user serviceable parts inside the charger e Follow local regulations for disposal of electrical components or batteries WARNING The battery charger is not a medical device and should not be used in a room where a patient may be present When the end user wishes to discard this product it must be sent to separate collection facilities for recovery and recycling e e 4 Care and Maintenance Method of Light Source Reprocessing WARNING Failure to comply with the following may result in damage to the light source and will void the product warranty The PLS is rated IPX7 for protection against ingress of water The entire light source is submersible in water and disinfectant solutions However the light source should not remain immersed in water or cleaning solutions for prolonged periods of time After the disinfection cycle has concluded remove the light source from the disinfection solution dry the light source and store the device in a clean and dry environment Thorough cleaning and rinsing are the first and most important steps in the reprocessing of your light source Without thorough cleaning and rinsing it might not be possible to achieve high level disinfection Cleaning is the rem
19. the battery cap and light source body prior to removing the battery cap Note Preventative Maintenance Over time the O ring on your PLS battery cap may become dry To prevent the O ring from cracking and falling off we recommend replacing the O ring with the provided greased O ring every 6 months or 300 disinfectant cycles Battery Cap O ring Figure 6 Replacing the O ring 10 5 Troubleshooting PROBLEM POSSIBLE CAUSE ACTION Loss of Illumination Battery power is low Replace battery with a freshly charged battery Battery cannot supply sufficient current at Change battery for a freshly charged this power setting battery Reduce the light intensity and continue using the current battery Recharge the battery as soon as possible Light Guide does not attach properly to the The endoscope has an adapter on it s light Refer to the guide below and remove endoscope post the adapter The endoscope and light source do not Contact Optim s Customer Service have a compatible coupling system Department 800 225 7486 Light intensity is low Foreign material or film on LED output Clean the taper with a cotton swab wet taper with isopropyl alcohol until the debris or film is cleared off Dry with compressed air or gas Light source becomes hot after prolonged use Light source has been left on for more than Turn the light source to a lower intensity at full power 30 minutes at full power setting if the examination must co
20. vide illumination for examination diagnostic and therapeutic applications particularly in endoscopy Please be sure to handle this optical instrument with care at all times The electrical and optical components can be damaged by physical trauma extreme temperatures or fluid invasion into the light source IMPORTANT This instrument is intended for use by persons thoroughly trained in the techniques that employ this light source such as endoscopy WARNING Avoid direct viewing of the high intensity light at the front of the Portable Light Source Always connect and disconnect the light source with the light turned off This manual describes the proper procedures for using the light source The manual also contains pertinent information on the proper care and handling of the light source during use reprocessing and storage Please read this entire manual carefully before using the light source If you have any questions concerning the material contained in this manual or the operation or safety of the equipment please contact our customer service department Precautions e Damage may occur to the light source if used improperly Read this Owner s Manual thoroughly before attempting to use the light source e Check all items upon receipt to assure damage has not occurred during shipment e Verify compatibility of all components and accessories used with the light source by contacting Optim LLC at 1 800 225 7486 or 1 508 347 5100 e
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