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1. e When soaking flexible endoscopes do not exceed or excessively dilute the disinfectant concentration recommended by disinfectant manufacturers follow manufacturers instructions e When soaking flexible endoscopes do not exceed the soak time recommended by disinfectant manufacturers 12 ENDOSAFE High Love Disinfection Efficacy SE aE Medivators Endoscopy p g Products High Level T Automated Manufacturer Disinfection Active Ingredient Endoscope Endo Bath Soak Solution Reprocessor AER Advanced ipe 0 5596 ortho v v Sterilization Cidex amp OPA Phthalaldehyde mE Not tested Products ENDOSAFE Msi Misit su UG Medivators amp Endoscopy 7 g Products High Level Mania Automated Manufacturer Disinfection Active Ingredient Endoscope Endo Bath i Soak Solution Reprocessor AER Advanced 2 4o Sterilization Cidex Glutaraldehyde Not tested Not tested Products Metrex MetriCide OPA 0 60 ortho V l 2 596 Acidic Not v Medivators Inc Rapicide Glutaraldehyde i sied aa Not tested T 0 575 ortho v v v l 2 Accelerated E TM STERIS nevita OX Hydrogen v Not tested Not tested Corporation Resert Peroxide Automated Endoscope Reprocessors AER and solutions not listed above are not an approved disinfection method for use with any Optim Nasopharyngoscope A WARNING Remove the Vent Cap during immersion in cleaning and disinfecting solutions VENT CAP ATTACH this VENT CAP
2. FDA CGMP 820 CDN MDR CMDCAS MDD 93 42 EEC Annex VII 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 CE PIN ces E s ric m FICE T Intertek Intertek USA TEL 1 800 225 7486 TEL 1 508 347 5100 FAX 1 508 347 2380 Part No NO14793D Rev D DCN No 07215 June 2015 21
3. Leak Tester connection to the endoscope may be loose Repeat procedure to verify e Ifthe needle drops again the endoscope may have a damaged seal and should not be immersed in any liquid DO NOT CONTINUE TO USE THE ENDOSCOPE Please contact Optim LLC s Service Center at 1 800 225 7486 or 1 508 347 5100 to arrange for evaluation and or repair e lf the needle stays in place immerse the entire endoscope in water Observe the endoscope for 30 seconds Articulate the Distal Bending Section up and down during this period holes in the soft covering of the Distal Bending Section may not be evident in a relaxed position e ASTEADY STREAM OF AIR BUBBLES INDICATES A LEAK IN THE ENDOSCOPE Remove the scope immediately from the water while the scope is still pressurized Air escaping the endoscope at the leak site will have prevented fluid invasion e lfaleak is detected the endoscope should not be immersed in solution or used for patient procedures after the leak test DO NOT CONTINUE USE OF THE ENDOSCOPE Reprocess the endoscope by washing all its external surfaces with an enzymatic cleaning solution Do not immerse the endoscope in the enzymatic cleaning solution Do not conduct high level disinfection or sterilization of the endoscope Please contact Optim LLC s Service Center at 1 800 225 7486 or 1 508 347 5100 to arrange for evaluation and or repair CAUTION Do not mistake the release of trapped air from the crevices on the endoscope s outer sur
4. id foetus teresa dass ed uat 12 Methods of Endoscope Reprocessing s cccccccsssseceeeceesseceeceeeeeeceesseeeeeeessseaeeeeessaaeeeeees 12 Il Endoscope Reprocessing Protocol ccccscscccccssececcesseecceeseeeceaseecseeeeeseseeessaseesssaeees 14 IP RCHC IO AINING mec mpm 14 Zi MAK 1 CSUN RE EE 14 3 Enzymatic Cleaning And RINSING ccccccssccccccsssseeeeeceeseeeeeeesaeeeeseeeeeseeeesesegeeeeeseas 14 4 High Level DISINTSCT ON wicca ticrssar E 15 Il EMGOSCODE Storage usted me 15 NOTE TROUTING Male NANICG zmsdusukobts rneeivsa vn ioiivreubyaudetitavanyvaanm E Law Cueva voe VUL YEN Nan aerials 15 5 Tfoublesnoollhig ode o oi e suc aUe tee eee aes eve argue LOO Re oiu Dci le I Ue cpu C 16 6 Emissions and Immunity Information 0 cc cc cccccccseeeeeceeeeeeeeeeeeeeeeeeeeesaaneeeesaneeesnaeees 17 Guidance and Manufacturer s Declaration EMISSIONS cccccccesseeeeeeeeaeeeeeeeseeeeeeesenaeees 17 Guidance and Manufacturer s Declaration IMMUNItY ccccceeeceeeeeeeeeeseeeeeeeseaeeeeeeeaeeees 17 Guidance and Manufacturer s Declaration Emissions Equipment and Systems That Are NOT Life supporting sseeeeeeeeseeeeeennneennn nnn 18 Hecommended Separation Distances between Portable and Mobile RF Communication Equipment and the ENTityXL SDXL NasoView Endoscope Equipment and Systems That Are NOT Life Supporting seeeeeeeesseeeeeeeeee
5. the battery fall to the floor or onto a hard object which could damage the battery 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 scope handle replace the battery compartment cap by screwing the cap clockwise until a tight seal is made Leak test the scope in water to ensure that the battery compartment is sealed Battery Figure 4 ENTityXL SDXL NasoView Endoscope Battery Compartment in Control Body 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 AC Adapter Battery Battery Contacts 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 on the front of the charger 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 e After the battery has been fully charged slide the battery out of the charger and unplug the AC adapter for the charger Charger Status Indicators Pre Charge Charge Complete Solid Green Standby LED off CAUTION e Do not expose the charger to fire w
6. video camera still photography system or teaching attachment the black dot on the Control Body must be aligned with the black dot on the Focus Ring Diopter Adjustment Ring The black lines with varying heights provide reference markers for various users of the same endoscope Articulation Lever The articulation lever controls the angular deflection of the Distal Tip Light Switch Lever The light switch lever controls the on off and intensity of light output Moving the lever towards the wider end of the intensity indicator increases the light intensity moving the lever towards the narrower end of the intensity indicator decreases the light intensity Identification Label The laser marked label includes the identity of the endoscope by model serial number manufacturer manufacturer telephone number and web address It also includes the IPX7 rating and Type BF Part symbols Battery Cap The battery cap seals the battery and electronics within the control body Vent Equalizes the air pressure inside the endoscope during storage and shipping when the Vent Cap is installed It is also the connection to the Leak Tester used to check that the endoscope is fully sealed and can be immersed in liquid or used for patient procedures Vent Cap Cap ON The Vent Cap must be PLACED ON for aeration and shipping The Vent Cap holds the Vent open and prevents damage caused by changes in pressure and temperature Cap OFF The Vent Cap must be REMOVE
7. 0 MHz 800MHz to 2 5GHz D 3 5 E3 Sqrt P Dz 3 5 E3 Sqrt P Dz 7 E3 Sqrt P 18 7 Repair Service Customer Service The Optim ENTityXL SDXL NasoView Nasopharyngoscopes are 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 3 If the scope needs to be sent to Optim a Returned Material Authorization number will be issued 4 The endoscope should then be returned to the address below for repair or replacement 5 Include a copy of the RMA inside package 6 Have RMA visible on package Returning Goods to Optim LLC Ship the endoscope with the Vent cap attached to the Vent 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 endoscope has been used in a clinical setting the endoscope must be reprocessed according to procedures outlined in the Care amp Maintenance section of this manual before shipment to Optim LLC Upon evaluation the customer will be contacted and advised of the findings and estimated repair cost Repairs will not begin until authorization
8. 00 to verify the compatibility of a cleaning method not listed in this manual The Optim Nasopharyngoscope is a semi critical device as defined by the Centers for Disease Control and requires high level disinfection or sterilization CDC Guidelines for the Prevention and Control of Nosocomial Infections Guidelines for Hand washing and Hospital Environmental Control 1985 Section 2 Cleaning disinfecting and sterilizing patient care equipment I The Optim ENTityXL SDXL Nasopharyngoscope is only to be used in the following disinfectants when the manufacturers instructions are properly followed High Level Disinfection Efficacy Optim has conducted validation testing to confirm high level disinfection can be achieved Material Compatible Optim has conducted material compatibility testing to determine that the ENTityXL SDXL still functions as intended after undergoing many cycles of use with the disinfectant Does not mean the disinfectant is validated for high level disinfection efficacy Optim will not cover under warranty any damage caused by use with a disinfectant system not approved by Optim Optim LLC encourages the following e Please refer to the Operator s Manual for detailed instructions on proper endoscope care e Always follow proper cleaning and disinfection methods e Always refer to and follow disinfectant and sterilant system complete manufacturers instructions for proper disinfectant and or sterilization
9. D for patient use leak testing and disinfection Removing the cap allows the Vent to close preventing fluid invasion Insertion Tube Depth Markers Depth marks are located at 10cm and 20cm from the Distal Tip of the Insertion Tube Bending Section The bending section deflects up and down when the Articulation Lever is rotated Distal Tip The termination of the Image fiber bundle at the Objective Lens and the Illumination fiber bundles Light Guides Battery Cap Focus Ring Control Body Insertion Tube Strain Relief VA Articulation Lever Eyepiece Vent Light Intensity Control 1 20cm Depth Marking 10cm Depth Marki uf ap ee arang EAE E un LI rus Figure 2 ENTityXL SDXL NasoView Control Body and Insertion Tube Specifications amp Accessories 3 6V 7OOMAHr minimum Safe Operating Storage and Transport Relative 0 95 RH Humidity Range Eyepiece Diopter Correction Range 4 to 8 Diopter Battery Charge Time Battery Type Lithium lon NP 700 3 6V 680mAHr minimum Battery Life at Full LED Power oafe Operating Temperature Range 18 26 C R Safe Storage and Transport Temperature Range 25 50 C H 12 o clock position oafe Operating Storage and Transport Relative 0 95 Humidity Range Eyepiece Magnification 30X or 45X available Scope amp Accessories Listing Part Number ENTityXL NasoView Nasopharyngoscope ENTitySDXL NasoView Nasopharyngos
10. L L C ENTityXL amp ENTitySDXL NasoView LED Illuminated Flexible Nasopharyngoscope 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 lic com sales optim llc com Table of Contents Page 1 TEAC CUUI CULO IR ME E n 4 MGIC AU ONS asn a a a A 4 ProCaUNONS soria ieo a E aa A 4 2 Endoscope Description us de cea d ica Pesca beue Sena detnuendialcuk dua sias Deva detwnunnchcyina MEE i 5 Endoscope Control Body Diagram and Descriptions esses 5 Insertion Tube Diagram and DeSCTIDtiONnS cccccseeeeceeceeeeeeeeceaeeeceeesseaeeceessaeaeeeeeeseeeeeeeeas 6 DDS CIC AUC Br M NEN ERREUR TEE Tr 7 Accessories Listing csccccceeseecceseeccceeeecceuseeecsaeeecsaeceeseuseeessaseeessauecessauseeessgeessseneeessaaeees 7 3 Endoscope Function and Operation cccccccccccccecceseeeeeeeeeeeeeeeesseeeeeeeeeseeeseeseesaaeseeeessaaess 8 EIndoscope PrepataltOLkgssuseisdu det ditt icsdtauspn a andes ia a put ed oque dedans 8 mipleiecieee udin tines 8 Bater and ON Me e T P G 9 Use of the Endoscope with Video ccccccccsseeeececceeeeeeeeeeceeeeseeeesseeseceeseseaaeeeeessaaeeeeeessageeeess 11 4 Cane Be MaintenaliGe oie i taceo aed esa
11. act Optim for evaluation Contact Optim or evaluation Contact Optim for evaluation Rotate focus ring until fiber pattern is in clear focus Clean lens with alcohol prepped pad to remove material or stain If material stains remain contact Optim Contact Optim for evaluation Contact Optim for evaluation Align dots of body and ring Clean objective end and light guide lens with 70 isopropyl alcohol 30 water to remove material or stains It is important to avoid touching the end tip of the endoscope and the end of the light guide as oils from one s fingers can stain lenses If staining remains contact Optim Replace battery with a freshly charged battery Change battery for a freshly charged battery Reduce the light intensity and continue using the current battery Recharge the battery as soon as possible Contact Optim for evaluation Contact Optim for evaluation Contact Optim for evaluation Reconnect Leak Tester and perform leak test again Contact Optim for repair 16 6 Emission and Immunity Information Guidance and Manufacturer s Declaration Emissions The ENTityXL SDXL NasoView endoscope is intended for use in the electromagnetic environment specified below The customer or user of the ENTityXL SDXL NasoView endoscope should ensure that it is used in such an environment RF Emissions The ENTityXL SDXL NasoView endoscope uses RF energy only for CISPR 11 its internal functio
12. ater 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 A WARNING The battery should be removed if the equipment is not likely to be used for some E time When the end user wishes to discard this product it must be sent to separate collection facilities for recovery and recycling 10 Use of the Endoscope with Video The endoscope may be used with video camera or still photography systems The endoscope s B style eyepiece will accommodate most video adapters for connection to a camera system and video chain When using a video camera be sure to align the black dot on the Control Body of the scope with the black dot on the Focus Ring This setting will optimize the focusing capabilities of your camera system Call Optim LLC at 1 508 347 5100 to order video adapters cameras monitors and accessories for Optim s Nasopharyngoscopes Align Dots Figure 6 Alignment of Black Focus Ring Marks 11 4 Care and Maintenance Method of Endoscope Reprocessing WARNING Failure to comply with the following may result in damage to the endoscope and will void the product warranty The ENTityXL SDXL NasoView endoscope is rated IPX7 for protection against ingres
13. cope 30X ENTitySDXL NasoView Nasopharyngoscope 45X Leak Tester Carrying Case Rechargeable Battery Battery Charger Cradle Battery Charger AC DC Adapter US Plug Battery Charger AC DC Adapter European Plug Battery Charger AC DC Adapter UK Plug Operator s Manual Vent Cap Greased O ring Kit Qty 3 3 Endoscope Function and Operation Endoscope Preparation Before use the endoscope should be reprocessed Please refer to the Care amp Maintenance Section of this manual for proper reprocessing protocol Before each procedure visually inspect the Insertion Tube for holes cuts or abrasions Run one s fingertips down the length of the Insertion Tube feeling for the above defects Do not squeeze the outer coverings tightly Check the Distal Tip deflection by rotating the Articulation Lever clockwise and counterclockwise Do not apply excessive force rotating the Articulation Lever Clean the Eyepiece and lens on the Distal Tip with an alcohol prep pad Do not use abrasive cleaners on the lens surfaces Endoscope Operation Hold the endoscope so that the control body fits comfortably in one hand allowing easy manipulation of the articulation lever with the thumb Use the other hand to manipulate the Insertion Tube of the endoscope CAUTION Avoid excessive bending or twisting of the endoscope insertion shaft While designed to bend excessive pressure can damage the fibers and internal components Do not manually bend the d
14. e in areas of heavy traffic where the endoscope may sustain physical damage e The endoscope should not be stored in the Carrying Case but in a well ventilated environment Avoid extreme temperatures direct sunlight and high humidity e Avoid immersing the endoscope for periods of time greater than recommended by the disinfectant manufacturer Prolonged immersion may damage the outer coverings of the endoscope and could result in fluid invasion into the endoscope e Do not attempt to disassemble the endoscope in any way There are no user serviceable parts and disassembly will void all warranties 2 Endoscope Description ee FP hye plete e DA Battery Cap pre Intensit Articulation Lever identification Label Figure 1 ENTityXL SDXL NasoView Endoscope Control Body Handle Control Body Eyepiece The eyepiece allows the user to visualize the image directly or to connect a standard video camera still photography system or teaching attachment to the endoscope The eyepiece is compatible with most C mount adapters and video camera systems Call Optim LLC at 1 508 347 5100 or 800 225 7486 for information on video adapters cameras processors and monitors Focus Ring The focus ring adjusts the image to the user s eyesight Adjust the focus by rotating the Focus Ring also known as the Diopter Adjustment Ring clockwise or counterclockwise until the fiber pattern is in clear focus Diopter Markings If using a
15. eeee 18 Ta or devo a teet T E 19 s Warani Yon econ pees cat RUN TP TP 20 9 SYMDO DSSCHIDUOINS seccta reas e 20 TO PAO VANS cwn a a a 21 T1 MendorJnforimiallOi e oos bro ta Det erede obtinet ast Ceo aan a burad edes a 21 WARNING The device is not supplied sterile Clean and disinfect the device prior to use employing the procedure listed in this manual WARNING The equipment is not suitable for use in the presence of flammable mixtures 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 The instrument is a TYPE BF Applied Part gt gt PE IPX7 The equipment is rated IPX7 WARNING the following methods of sterilization and disinfection will result in damage to the endoscope and should not be used Ethylene Oxide autoclave ultrasonic chlorides formaldehyde and hydrogen peroxide The device is covered under US Patent s For a complete listing visit our website at www optim llc com patents 1 Introduction Indications The Optim ENTityXL amp ENTitySDXL NasoView Nasopharyngoscopes are intended to be used for oral or nasal introduction for the examination of the upper airway from the nasal passage to the vocal cords Please be sure to handle the fiber optic instrument with care at all times The fiber optics are comprised of t
16. face with a leak Trapped air can be released by tapping the endoscope genily after immersing the endoscope in water e Absence of a steady stream of air bubbles confirms that the endoscope is watertight Remove the endoscope from the water and disconnect the Leak Tester from the endoscope It is now safe to immerse the endoscope in solution Enzymatic Cleaning and Rinsing 1 Fill a 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 endoscope Wash all debris from the exterior of the endoscope by gently brushing and wiping the instrument while submerged in the detergent solution 3 Rinse the endoscope in clean water 4 Wipe dry the exterior of the endoscope with a soft clean cloth 14 High Level Disinfection HLD with Cidex OPA 0 55 ortho Phthalaldehyde Solution Confirm HLD is approved by Optim prior to reprocessing refer to chart on Page 13 1 2 3 Verify that the Vent Cap is removed Prepare the disinfectant solution in accordance with the solution manufacturer s label Completely immerse the endoscope in the disinfectant solution for the recommended time and temperature as indicated on the label of the disinfectant Thoroughly rinse the exterior of the endoscope with large amounts of clean water NOTE It is suggested that all rinsing after disinfection should be done with water that has been filtered by pa
17. g PROBLEM POSSIBLE CAUSE Articulation feels stiff Damaged distal bending section causing impairment of articulation Articulation alignment is no longer up down Insertion tube rotated from excessive twisting Control wires are stretched or broken from use Loss of articulation up and or down Cloudy or Foggy Image Focus ring not adjusted properly Eyepiece lens or objective lens is obscured by material or is stained Fluid invasion of the image bundle Damaged lens at the distal tip If using a video system still photography or teaching attachment White dot on control body not aligned with white dot on focus ring Loss of Illumination Light guides obscured by material or are stained Battery power is low Battery cannot supply sufficient current at this power setting Illumination light blinks on and off Insertion tube has developed folds and or wrinkles Long term effects of disinfecting the endoscope in a chemical solution Wiping the endoscope with excessive pressure may cause the material to stretch and buckle Insertion tube has dent s Dents can be caused by physical damage to the endoscope i e closing the case on the insertion tube Rainbow glare seen in the image field Fluid invasion of the endoscope Leak Tester not connected to EO vent properly Hole or crack in the endoscope has broken the watertight seal of the endoscope Loss of pressure during leak testing ACTION Cont
18. hin glass fibers that can be damaged by physical trauma extreme temperatures or fluid invasion into the endoscope IMPORTANT The instrument is intended for use by persons thoroughly trained in the techniques of nasopharyngoscopy This manual describes the proper procedures for preparing and using the endoscope This manual also contains pertinent information on the proper care and handling of the endoscope during use reprocessing and storage Please read this entire manual carefully before using the endoscope For 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 endoscope if used improperly Read this Owner s Manual thoroughly before attempting to use the endoscope 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 endoscope by contacting Optim LLC at 1 800 225 7486 or 1 508 347 5100 e Avoid excessive bending or twisting of the endoscope Insertion Tube While designed to bend too much force can damage the fiber bundles and internal components e Do not use excessive force when wiping the endoscope Insertion Tube Hold the endoscope by the Control Body and genily wipe back and forth along the Insertion Tube with a soft material such as 4x4 gauze e Avoid storing or using the endoscop
19. istal tip always use the articulation lever to articulate the tip up or down Pere A S Figure 3 Suggested Method for Holding the ENTityXL SDXL NasoView Endoscope During Use While viewing through the Eyepiece rotate the Focus Ring clockwise or counterclockwise until the fiber pattern is in clear focus When using a video camera still photography system or teaching attachment with the endoscope be sure the black dot on the Control Body is aligned with the black dot on the Focus Ring Turn on the light by rotating the lever on the side of the Control Body near the Articulation Lever Adjust the brightness to the desired level by the rotating lever Introduce the endoscope into the patient and operate the Articulation Lever as necessary to guide the Distal Tip amp Insertion Tube for advancement and observation At the completion of the exam remove the endoscope under direct visualization and with the Articulation Lever in the neutral position Battery and Charger The ENTityXL SDXL NasoView s internal LED light source operates on a single Lithium ion battery and provides approximately 40 minutes of continuous operation when a new battery is fully charged When the battery is drained the light will flicker on and off indicating it is time to recharge the battery To remove the battery simply unscrew the stainless steel battery cap and turn the scope handle over so the battery drops out into your other hand Please take care not to let
20. lectric shock This instrument is rated a TYPE BF Applied Part PX7 The equipment is rated IPX7 and is protected against the effect of immersion between 15cm and 1m S N This symbol indicates the product s Serial Number TF These symbols found on the light intensity lever indicate that the switch is to be used to Q turn the light source on and off Moving the light intensity lever towards the wider end of UN this symbol increases the light intensity Moving towards the narrower end decreases the light 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 20 10 Approvals UL 60601 1 2003 Part 1 CAN CSA C22 2 601 1 1990 Part 1 IEC 60601 2 18 1996 Part 2 2 18 IEC 60601 1 2 2001 A1 2004 CISPR 11 2004 Group 1 Class B CENELEC EN 60601 1 Part 1 A1 93 A2 95 The CE mark on this product indicates that it has been tested to and conforms with the provisions noted within the Medical Device Directive 93 42 EEC 2007 47 EC 21 09 2007 Authorized Representative Scanlan Group B V Postbus 75664 1118 ZS Schiphol Triport The Netherlands Telephone 31 0 20 653 0553 ISO 9001 2008 ISO 13485 2003
21. mpliance Electromagnetic Environment Guidance Test Level EXT Radiated RF 3 V m Portable and mobile communications EN IEC 61000 4 3 80 MHz to 2 5 GHz equipment should be separated from the endoscope by no less than the distances calculated listed below D 3 5 E3 Saqrt P 80 to 800 MHz D 7 E3 Sqrt P 800 MHz to 2 5 GHz 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 E3 Interference may occur in the vicinity of equipment containing a transmitter Recommended Separation Distances Between Portable and Mobile RF Communication Equipment and the ENTityXL SDXL NasoView Endoscope Equipment and Systems That Are NOT Life Supporting Hecommended Separation Distances for the ENTityXL SDXL NasoView Endoscope The ENTityXL SDXL NasoView Endoscope is intended for use in the electromagnetic environment in which radiated disturbances are controlled The customer or user of the ENTityXL SDXL NasoView Endoscope can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the ENTityXL SDXL NasoView Endoscope as recommended below according to the maximum output power of the communication equipment Max Output Power Separation m Separation m Separation m watts 150KHz to 80MHz 80 to 80
22. n Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Harmonics N A IEC 61000 3 2 IEC 61000 3 3 The ENTityXL SDXL NasoView endoscope is suitable for use in all establishments including domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Guidance and Manufacturer s Declaration Immunity The ENTityXL SDXL NasoView endoscope is intended for use in the electromagnetic environment specified below The customer or user of the ENTityXL SDXL NasoView endoscope should ensure that it is used in such an environment Immunity Test EN IEC 60601 Compliance Electromagnetic Environment Test Level Level Guidance ESD Floors should be wood concrete or EN IEC 61000 4 2 6KV Contact ceramic tile If floors are synthetic the 8KV Air relative humidity should be at least 3096 Power Frequency Power frequency magnetic fields should 50 60 Hz 3 A m be that of a typical commercial or Magnetic Field hospital environment EN IEC 61000 4 8 17 Guidance and Manufacturer s Declaration Emissions Equipment and Systems That Are NOT Life supporting The ENTityXL SDXL NasoView endoscope is intended for use in the electromagnetic environment specified below The customer or user of the ENTityXL SDXL NasoView endoscope should ensure that it is used in such an environment Immunity EN IEC 60601 Co
23. or a purchase order is issued indicating the approval of charges 19 8 Warranty I The Optim LLC Models ENTityXL and ENTitySDXL Flexible LED Nasopharyngoscopes are warranted to be free from defects in materials and workmanship for a period of two 2 years from the date of invoice 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 MERCHANT ABILITY 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 e This symbol indicates that this device provides a certain level of protection against e
24. prior to Figure 7 Control Body with Vent Cap Attached 13 Il Endoscope Reprocessing Protocol 1 Pre Cleaning 2 Leak Testing 3 Enzymatic Cleaning and Rinsing 4 High Level Disinfection with Cidex OPA 0 5596 ortho Phthalaldehyde Solution Pre Cleaning Optim recommends the endoscope be pre cleaned immediately after every patient procedure This will prevent patient material from adhering to the endoscope Dried material is difficult to remove and can render the disinfection or sterilization process ineffective Gently wipe all debris from the Insertion Tube and Distal Tip 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 Leak Testing After every procedure in preparation for high level disinfection or sterilization the endoscope should first be tested to ensure that it is watertight This is accomplished using the Leak Tester Gloves should be worn when performing the Leak Test procedure as the endoscope has not yet been reprocessed e Remove Vent Cap Connect the Leak Tester to the Vent by aligning the pin in the Leak Tester connecior with the groove on the Vent pushing down and rotating the Leak Tester connector clockwise 1 4 turn e Pump the hand bulb of the Leak Tester until the needle is within the 140 180mmHg or the green gauge area Do not exceed 180mmHg Observe the needle for 10 seconds If the needle drops the
25. s of water The entire endoscope is submersible in water and disinfectant solutions However the endoscope should not remain immersed in water or cleaning solutions for prolonged periods of time After the disinfection cycle has concluded remove the endoscope from the disinfection solution dry the endoscope 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 the endoscope Without thorough cleaning and rinsing it might not be possible to achieve high level disinfection Cleaning is the removal of all adherent visible soil i e blood protein substances and other debris from the surface crevices and joints of the endoscope Use caution when cleaning and disinfecting the endoscope some methods may be harmful to the endoscope and could result in extensive damage Manual cleaning is the recommended method for cleaning your precision endoscope 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 51
26. ssage through a 0 2 micron filter or otherwise treated by a method documented to improve the microbiological quality of water ASTM F 1518 A final rinse using 7096 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 Dry the exterior of the endoscope with a soft clean towel Ensure the Eyepiece and Distal Tip lenses are free from solution residue Ill Endoscope Storage The endoscope should be stored in a dry well ventilated environment Avoid extreme temperatures direct sunlight and high humidity Avoid storing the endoscope in areas of heavy traffic where the endoscope may sustain physical damage Do not store the endoscope in the carrying case The carrying case is not sufficiently ventilated for storage of the endoscope The carrying case is intended only for transport of the endoscope The endoscope should be completely clean and dry before storing When storing the endoscope be sure to keep the Insertion Tube straight Note Routine Maintenance Over time the O ring on your endoscope battery compartment 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 O ring Control poe Opened Battery Compartment Battery Figure 8 Battery compartment open for replacing O ring 15 5 Troubleshootin

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