ENT-4000/4500
Contents
1. Reprocessing CAUTION Because of the possibility that a sheath could be torn or that the endoscope or sheath could come in contact with contaminated surfaces the user should exercise care when handling the endoscope whether sheathed or unsheathed After removing the Sheath inspect the Insertion Tube and Distal Bending Section and confirm that these areas are dry If moisture is observed there may have been a leak into the Sheath during the procedure providing the endoscope was dry when the Sheath was attached In this case the endoscope must be high level disinfected and or sterilized following the instructions given in this chapter For Cleaning Gently wash all external surfaces of the endoscope with an appropriate instrument grade detergent An ample size basin must be used for cleaning the endoscope If the basin is too small the endoscope may inadvertently be kinked or damaged during cleaning After washing thoroughly rinse the outside of the endoscope with clean lukewarm water and place it on a clean dry surface For Intermediate Level Disinfection Wipe down the entire endoscope with a soft lint free cloth or gauze soaked in 70 ethyl or isopropyl alcohol Ensure that all external surfaces of the endoscope are thoroughly dried prior to attaching another Sheath or storing the endoscope High Level Disinfection and Sterilization In the event that the endoscope is contaminated it should be high level disinfecte2. Return the endoscope to Vision Sciences Inc for repair Refer to Chapter 8 Warranty and Service Clean the Distal Tip with an alcohol prep pad to remove material or stain Excess staining may not be correctable and the lens may require replacement Adjust Light Intensity setting Return the endoscope to Vision Sciences Inc for repair Refer to Chapter 8 Warranty and Service Table 7 1 Troubleshooting 32 ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual PROBLEM PROBABLE CAUSE Wrinkles and or folds in the Insertion Tube Insertion tube is dented Loss of pressure during leak test These may be a result of gt excessive force applied to the Insertion Tube during cleaning or Sheath removal or the long term effects of repeated immersion in chemical disinfecting solutions which could stretch and weaken the outer coverings Dents can be caused by physical trauma to the endoscope e g closing the case on the Insertion Tube The Leak Tester is not connected properly to the Vent Valve The Leak Tester s Pressure Relief Valve is open A hole or crack has broken the endoscope s watertight seal Troubleshooting SUGGESTED ACTION Return the endoscope to Vision Sciences Inc for repair Refer to Chapter 8 Warranty and Service Return the endoscope to Vision Sciences Inc for repair Refer to Chapter 8 Warranty and Service Re connect the Leak Tester and
3. process The Vent Cap must be removed for the STERIS sterilization process CAUTION STERRAD and STERIS sterilization compatibility applies only to endoscopes which feature the S symbol on the Control Body The ENT 4000 4500 Flexible Nasopharyngo Laryngoscope has been validated for material and functional compatibility with the following sterilization systems cycles STERRAD STERRAD STERRAD STERI S 100S NX 100NX System 1E Y Y Y Short and Long Short and Long Flex Cycle Y Cycles Cycles Only Table 5 1 STERRAD and STERI S Validated Systems Cycles 28 ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 6 Care and Storage Follow the instructions in this chapter if you anticipate that the endoscope will not be used for a prolonged period of time Do not leave the endoscope exposed to the elements in such circumstances Storage Follow the instructions below when storing the ENT 4000 4500 Flexible Nasopharyngo Laryngoscope DO NOT store the endoscope with Slide On EndoSheath Technology installed on the Insertion Tube Over time the Sheath material may adhere to the Insertion Tube and become difficult to remove When storing the endoscope be sure to keep the Insertion Tube as straight as possible The equipment should be completely clean and dry before storing The endoscope should be maintained in a clean condition during storage so that it is ready for subsequent use The en
4. Avoid excessive bending or twisting of the endoscope s Insertion Tube Although they are designed to bend excessive bending can damage the fiber bundles and internal components Should the endoscope develop a severe kink or bend do not attempt to straighten the Insertion Tube Contact Vision Sciences Customer Service for assistance DO NOT apply excessive pressure to the Angulation Lever as it could damage the endoscope and lead to patient injury DO NOT look directly at the intense light emitted from the endoscope tip to avoid the possibility of eye injury ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 5 Important Information Reprocessing The endoscope must be properly reprocessed by cleaning disinfection and or sterilization before its first use and after each subsequent use Using an endoscope in a procedure that has not been properly reprocessed presents an acute infection control risk to both the patient and medical personnel performing or assisting in the procedure Always wear appropriate personal protective equipment when reprocessing the endoscope such as a gown gloves and face and eye shields Use extreme care when reprocessing the endoscope Do not forcefully pull push or drag wipes towels or cloths along the Insertion Tube The use of excessive force could damage the endoscope DO NOT immerse the endoscope in disinfectant solution for long periods of time in excess of 1 hour Prolong
5. and Caution statements that must be observed by endoscope users to ensure patient and user safety If you are a first time endoscope user Vision Sciences Inc strongly recommends that you read this manual from beginning to end and become intimately familiar with the endoscope and its use If you are an experienced endoscope user select specific chapters and or sections that pertain to features and procedures that you are using Organization of this Manual Following is a list of the chapters included in this manual Each chapter s title is listed at the top of all pages after the title page so that you can quickly access the information you need Chapter 1 Symbols and Terms This chapter defines the symbols on the endoscope and peripheral equipment There is also a brief list of the terms that are commonly used in the manual Chapter 2 Important Information The information in this chapter is a summary of critical Warning and Caution statements in the manual This information is essential to the safe operation and reprocessing of the endoscope Vision Sciences Inc strongly recommends that this chapter be read thoroughly and completely understood by all users before working with the endoscope Chapter 3 Endoscope and Accessories Introduces the ENT 4000 4500 Flexible Nasopharyngo Laryngoscope and compatible peripheral equipment This chapter includes instrument diagrams identifies components and defines their functions EN
6. covered with a sterile Sheath for every procedure For cleaning and disinfection procedures when using the Slide On EndoSheath Technology see Cleaning After Slide On EndoSheath Technology Use on page 23 The endoscope must be properly reprocessed by cleaning disinfection and or sterilization before its first use and after each subsequent use according to the protocols in this section Using an endoscope in a procedure that has not been properly reprocessed presents an acute infection control risk to both the patient and medical personnel performing or assisting in the procedure CAUTION Some methods of disinfection and sterilization may be harmful to the endoscope and exposure to them could result in extensive equipment damage Please contact Vision Sciences Inc Customer Service to verify the compatibility of a cleaning method not listed in this manual and or a complete list of functionally compatible agents Clean the endoscope immediately after use in a procedure Failure to do so may allow patient debris to harden on the endoscope s external surfaces which can become difficult to remove and could inhibit subsequent disinfection sterilization processes Do not use an endoscope that has been determined to have a leak and do not immerse such an endoscope in any fluids Fluid entry into the endoscope can cause equipment damage and render the endoscope unfit for patient use Always wear appropriate personal protective equipm
7. days from the date of the invoice Upon receipt of the ENT 4000 4500 Flexible Nasopharyngo Laryngoscope for repair Vision Sciences Inc will evaluate the instrument and make the final decision as to the warranty status The above warranties are in lieu of all other warranties either expressed or implied including warranties of fitness or merchantability Vision Sciences Service Information ENT 4000 4500 Flexible Nasopharyngo Laryngoscopes are serviced at the Vision Sciences facility in Orangeburg New York Use the following procedure to expedite returned goods for repair or replacement 1 Telephone your Regional Distributor Territory Manager or Vision Sciences Customer Service Monday through Friday from 8 00 AM to 5 00 PM EST USA customers call 1 800 874 9975 International customers call 1 845 359 0276 2 Provide a detailed description of the problem ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 35 Warranty and Service 3 If troubleshooting cannot solve the problem a Returned Goods Authorization RGA number will be issued 4 Complete an Incident Report Form and send it to Vision Sciences Inc along with the returned goods Returned merchandise will only be accepted with an RGA number Shipping to Vision Sciences Inc If the ENT 4000 4500 Flexible Nasopharyngo Laryngoscope WARNING has been used in a Clinical setting disinfect all system components before shipping as descr
8. for the period of time recommended by the disinfectant manufacturer Following disinfection remove the endoscope from the solution Rinsing 1 2 26 Immerse the endoscope in a container of clean lukewarm water Thoroughly rinse the outside of the endoscope with clean lukewarm water and place it on a clean dry surface Wipe all external surfaces of the endoscope with a soft lint free cloth or gauze 4x4 until it is completely dry Confirm that the Lens at the endoscope s Distal Tip is free of disinfectant residue ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual Reprocessing Ethylene Oxide EtO Gas Sterilization The ENT 4000 4500 Nasopharyngo Laryngoscope may be sterilized using a validated ethylene oxide EtO gas sterilization protocol following the processing parameters given below CAUTION If the Vent Valve is not opened during gas sterilization the increased heat and pressure from the sterilization process will cause pressure to build up inside the endoscope and could rupture the watertight seals and softer materials of the endoscope EtO Gas Sterilization Parameters Temperature 125 5 F 52 C 3 C Humidity 50 10 Exposure Time 3 hours 1 0 hour EtO Concentration 600 mg liter Post Sterilization Aeration 12 hours at 130 F 55 C or 72 hours at 75 F 24 C L NOTE EtO gas sterilization at the above parameters has been validated by Vision Sciences Inc and wi
9. may be immersed in a glutaraldehyde solution for the amount of time recommended by the disinfectant manufacturer to achieve high level disinfection CAUTION ML is imperative that the endoscope be leak tested and cleaned prior to immersion in high level disinfectant Failure to do so may not detect leaks that could allow fluid ingress and damage the endoscope Failure to clean the endoscope may allow gross debris to remain on external surfaces which could impair proper disinfection If the endoscope fails the Leak Test do not immerse it in fluids and do not use the endoscope in a procedure Contact Vision Sciences Customer Service to arrange for repair and or service of the endoscope Cleaning 1 Gently pat down the Insertion Tube and wipe the Distal Bending Section with a soft lint free cloth or gauze 4x4 to remove visible debris 2 Perform the Leak Test procedure 3 Gently wash down all external surfaces with an enzymatic cleaning solution and soak the endoscope in the enzymatic cleaning solution for the time recommended by the enzymatic solution s manufacturer 4 Remove the endoscope from the cleaning solution and rinse it thoroughly with clean lukewarm water 5 Dry all external surfaces of the endoscope High Level Disinfection 1 3 Immerse the endoscope in the disinfectant solution at the temperature recommended by the disinfectant manufacturer Allow the endoscope to remain immersed in the disinfectant solution
10. nnn nana 7 Inspect the Standard Securities semet li uro hus et qd da ead ciao 8 Equipment Diagrams idee eorr tts da das ki 9 ENT 4000 4500 Flexible Nasopharyngo Laryngoscope ssm m 9 A COADA 12 Eight SOUf CBS o cene RO UA 12 BLS 1000 Battery Powered Light Source ree treten te eee 12 bight Guide Cables tina A kleben 12 Add On Gamera System na Sea Rep one e ena ER mat s coll stil al 12 Leak Testing ar ae een 12 REPO A e 12 Light Source Adapters Light Guide Sleeves unnnssnnnnnennnnnnnnnnnnnnnnn anne nennen nenn 13 4 Preparation Inspection and Operation nne 15 Preparation and risDection iue ee ee 16 Endoscope Operation with BLS 1000 Battery Powered Light Source 16 Endoscope Operation Other Light Source ssssseemee 18 5 Reprocessing iunc A dox Ode ae CE di da 19 ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual iii Table of Contents Reprocessing EPS A EL 20 CORTESIA td A DAS A A 20 Attach the Leak Tester to the Endoscope usseeseesennnnnnennnnnnnnnnnnnnnnnnnnennnne nenne nennen 21 Leak Test Connection Components cinc il 21 Pr ssurize tAe ENd SCO Pe A Na ie ce De waht 21 Cleaning Disirifection SterilizatiOn sea a AS 23 Cleaning and Intermediate Level Disinfection After Slide On Endo Sheath A DoD OD ns arr tok 23 High Level Disinfection and Sterilizatio
11. of the estimated repair costs Repairs will not begin on any equipment until authorization or a purchase order has been issued indicating approval of the charges 36 ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual Appendix Specifications ENT 4000 4500 Distal Tip Diameter ENT 4000 3 35 mm ENT 4500 2 40 mm Insertion Tube Diameter ENT 4000 3 45 mm ENT 4500 2 4 mm Insertion Tube Working Length Field of View ENT 4000 90 ENT 4500 80 Environmental Effects on Optical Performance Maximum Angulation 140 up down Operating Environment Temperature 50 to 104 F 10 to 40 C Relative Humidity 30 to 85 Air Pressure 700 to 1060 hPa Storage Environment Temperature 14 to 140 F 10 to 60 C Relative Humidity 0 to 95 Air Pressure 700 to 1060 hPa EC 60601 2 18 Degree of Protection Against Fluid Invasion IPX7 Fully Immersible per Reprocessing Instructions Table A 1 Specifications ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 37 Appendix Infection Control Information The ENT 4000 4500 Flexible Nasopharyngo Laryngoscopes are validated for use with the Slide On EndoSheath Technology This equipment is designed to offer practitioners the ability to perform safe efficient endoscopy The Slide On EndoSheath Technology has been proven to be an effective barrier to micro organisms as small as 27 nanometers Efficacy testing for barrier qualities has been
12. perform the test again Close the Pressure Relief Valve Return the endoscope to Vision Sciences Inc for repair Refer to Chapter 8 Warranty and Service ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 33 8 Warranty and Service Warranty nformation A NOTE Alterations or repairs done by persons not authorized by Vision Sciences Inc will void this warranty Vision Sciences Inc is not liable for any damages to the ENT 4000 4500 Flexible Nasopharyngo Laryngoscope resulting from misuse negligence or improper cleaning or storage The warranty defined herein Shall apply only to the original buyer In no event shall Vision Sciences Inc be liable for anticipated profits consequential damages or loss of time incurred by the buyer with the purchase or use of this equipment NOTE Vision Sciences Inc sells many of its products through regional distributors Before sending equipment to Vision Sciences Inc contact your regional distributor for repair return procedures Vision Sciences Inc warrants that the ENT 4000 4500 Flexible Nasopharyngo Laryngoscope and its accessories will be free from defects in materials and workmanship for a period of one year from the date of the invoice Replacement parts are warranted for a period of ninety 90 days from the date of the invoice All non warranty repairs will be warranted to be free from defects in materials and workmanship for a period of ninety 90
13. practice prior to endoscope insertion 9 Lubricate the outside of the endoscope or Sheath if used before inserting the endoscope into the patient Vision Sciences Inc recommends that the endoscope or Sheath if used be lubricated with water or a water based lubricant just prior to insertion 10 Introduce the endoscope into the patient using normally acceptable clinical practice Operate the Angulation Lever as necessary for advancement and observation 11 Upon completion of the procedure withdraw the endoscope under direct visualization without holding the Angulation Lever This will allow the Distal Bending Section to move freely during withdrawal 12 When the procedure is finished rotate the outer body of the BLS 1000 to the OFF position and confirm that the light is off ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 17 Preparation Inspection and Operation Endoscope Operation Other Light Source 18 Te IIS ae 10 Connect the Light Guide Cable to the endoscope Secure the appropriate Light Guide Sleeve to the cable Connect Light Guide Cable to the Light Source Hold the endoscope so that the Control Body fits comfortably in your hand allowing you to manipulate the Angulation Lever The other hand is free to manipulate the Insertion Tube Turn the light source on Adjust the brightness to the desired level using the light source s brightness adjustment controls Prepare the pati
14. the disposable ENT Slide On EndoSheath Technology for the ENT 4000 4500 Nasopharyngo Laryngoscope ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 1 2 Important Information The information in this chapter is essential for the correct and safe operation of the ENT 4000 4500 Flexible Nasopharyngo Laryngoscope Please read and understand this information before preparing or using the endoscope or any peripheral equipment with which it will be used Intended Use The Vision Sciences ENT 4000 4500 Flexible Nasopharyngo Laryngoscope is intended to be used for flexible endoscopic examination of the upper airway vocal cords and or nasal passages NOTE The ENT 4000 4500 is not intended for electrosurgical procedures Do not use the endoscope for any purpose other than these intended uses User Qualifications This equipment should only be used in a medical facility by or under the supervision of a physician trained in laryngoscopy Only use the endoscope and peripheral equipment according to the instructions and under the operating conditions described in this manual Failure to do so could result in compromised safety equipment malfunction and or instrument damage For preparation of the device before use and disassembly and proper cleaning after use users should be adequately trained in the proper procedures Failure to thoroughly understand these details such as but not limited to EndoSheath T
15. 1 07 6162 07 6010 See List on Page 13 07 3053 07 3050 07 3058 07 3059 Installation Stand Floor Model Installation Stand Clamp Model Installation Stand Wall Mount Endoscope Leak Tester Light Guide Sleeve Adapter BLS 1000 Battery Powered Light Source Set with Batteries and Battery Charger BLS 1000 Battery Powered Light Source Replacement BLS 1000 Battery Charger Replacement BLS 1000 Batteries 2 Batteries Replacement Table 3 1 ENT 4000 4500 Nasopharyngo Laryngoscope Standard Sets Contact distributor for region specific configuration ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual Endoscope and Accessories Equipment Diagrams ENT 4000 4500 Flexible Nasopharyngo Laryngoscope N Pa Set A Sn IN NS NY es Ne d j AN BN PU pod Ne e A u Figure 3 1 ENT 4000 4500 Nasopharyngo Laryngoscope ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 9 Endoscope and Accessories ENT 4000 4500 Flexible Nasopharyngo Laryngoscope Figure 3 2 ENT 4000 4500 Nasopharyngo Laryngoscope Control Body Endoscope and Control Body 1 Angulation Lever This integral component of the Control Body controls the endoscope s Distal Tip deflection 2 Light Guide Cable Connector Light Post One end of the Detachable Light Guide Cable is inserted into the external Light Source to allow light to be projecte
16. S 1000 onto the endoscope Light Post Verify that the Light Source is OFF until needed 16 ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual Preparation Inspection and Operation 5 Just prior to the procedure rotate the outer body of the BLS 1000 to the ON position CAUTION Point the light emitting area of the Light Source away from eyes before turning on the light 6 Verify light emission by viewing through the eyepiece While viewing through the eyepiece rotate the Diopter Adjustment Ring clockwise or counter clockwise until the fiber pattern in the image field is clearly focused Do not handle the BLS 1000 with contaminated gloves If the BLS 1000 becomes contaminated it must be reprocessed per the protocols in the BLS 1000 Battery Powered Light Source User s Manual CAUTION Avoid excessive bending or twisting of the endoscope s insertion tube particularly at the distal end While the tube is designed to bend excessive pressure can damage the fiber bundles and internal components 7 Hold the endoscope so that the control body fits comfortably in your hand allowing easy manipulation of the Angulation Lever The other hand is free to manipulate the Insertion Tube of the endoscope CAUTION Excessive angulation or excessive pressure on the Angulation lever may cause equipment damage Do not exert force to move the lever beyond its natural limits 8 Prepare the patient using normally acceptable clinical
17. T 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual i How to Use This Manual Chapter 4 Preparation Inspection and Operation This chapter describes how to prepare the endoscope and peripheral equipment for use and the assembly of the equipment into a system The chapter also leads you through a detailed inspection procedure to confirm that the equipment is undamaged and working properly before it is used in a procedure Chapter 5 Reprocessing This chapter contains important instructions on the proper cleaning disinfection and sterilization of the endoscope before its first use and after each subsequent use Strict adherence to the instructions in this chapter will render the endoscope patient ready for each procedure Chapter 6 Care and Storage f the equipment will not be used for a prolonged period refer to this chapter for instructions on safe secure storage Chapter 7 Troubleshooting Describes possible problems that may be encountered with the endoscopic system and suggests corrective actions to take towards resolving minor problems Chapter 8 Warranty and Service This chapter contains the terms of the Vision Sciences warranty on the endoscope any restrictions that apply and user actions that may void the warranty if taken This chapter also includes shipping instructions in case the endoscope must be returned to Vision Sciences Inc for repair or service The Appendix contains the technical specifi
18. VISION sciences USER S MANUAL VISION SCIENCES Flexible Nasopharyngo Laryngoscope ENT 4000 4500 NOTE Federal USA law restricts this device to sale by or on the order of a physician or other appropriately licensed medical professional www visionsciences com 02009 2012 Vision Sciences Inc All rights reserved Printed in the United States of America The information contained herein is the exclusive and confidential property of Vision Sciences Inc No part of this manual may be disclosed or reproduced in whole or in part without permission from Vision Sciences Inc How to Use This Manual This User s Manual contains the recommended procedures for preparing and using the Vision Sciences ENT 4000 4500 Flexible Nasopharyngo Laryngoscope It is intended for physicians and other medical personnel who will come in contact with the endoscope before during and after any patient procedures performed with it The manual also contains pertinent information on the proper care and handling of the endoscope Please read and become familiar with this entire manual before using the endoscope This manual contains the following information e Description of the endoscope e The endoscope s intended use e Components and features of the endoscope and peripheral equipment used in conjunction with the endoscope e Complete instructions on endoscope preparation inspection operation reprocessing and storage e Warning
19. actuating the Angulation Lever up and down MAIRENA Avoid applying excessive pressure when using the Angulation Lever Doing so could damage the angulation mechanism 4 Clean the Lens on the endoscope s Distal Tip with an alcohol prep pad IM YE REIN Po not use abrasive materials to clean the Lens Doing so could damage the Lens and impair the endoscope s imaging capability 5 Ensure that the proper Light Guide Adapter is securely connected to the Light Guide Cable 6 Securely insert the Light Guide Cable into the light source 7 Look through the Eyepiece and rotate the Diopter Adjustment Ring until the fiber pattern is clearly focused 8 When using a video camera still photography system or teaching attachment with the endoscope make sure that the white dot on the Control Body is aligned with the white dot on the Diopter Adjustment Ring Endoscope Operation with BLS 1000 Battery Powered Light Source l Prior to use the BLS 1000 should be reprocessed Please refer to the BLS 1000 Battery Powered Light Source User s Manual for proper Reprocessing procedures and compatibilities 2 f necessary insert charged or new batteries into the BLS 1000 3 Verify the BLS 1000 is in proper working condition before attaching to the endoscope by examining the outer cover for damage secure cover fit and with Light Source powered OFF verify that the window over the bulb is clear and not obstructed 4 Thread the BL
20. cations for the ENT 4000 4500 Nasopharyngo Laryngoscope and infection control information Additional Information The information in this User s Manual is subject to change without notice If you have any questions regarding any of the material contained in this manual or wish to confirm that this is the most comprehensive information available for these products please contact your local distributor or Vision Sciences Customer Service Department at 800 874 9975 or 1 845 359 0276 International ii ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual Table of Contents How to Use This Manual coi ada ade i Organization of this Manual Aa DA EREA REED eR dla hacen i Additional ONO edd dues ne ai dad a deat ita ii 1 Symbols and Terms ein 1 VITUS and fre tan P areas ad toni Puta Pa Vande len fecil ol aet aceon ki ntl Edda 1 TPS MPa MET UE EE HTTP I 2 Important I nformation enses DURA UNA A DUN enn A AAA RRA una GUNDA DUN AU UU nennen 3 A De Aa E TETEA A FRCHER ERENDETESLUPGEENRERSUSEE FERAREEBED 3 User QualifiCatiotiS sc ete dede e ED eni A 3 REPROCESSING ME DOMI CR 3 Maintenance and Repair e Sepe dev pde A 4 Stabia WOES uae caca ish cie EE ens Rid secant one AE 4 Important Safety Precautions dace a 4 Preparation Inspection and Assembly 4 During UE UL 5 REPROCESSING ie Eee dp amc poc d MU Ue fun Sd ME 6 3 Endoscope and Accessories eeeeesiee sies DUB RAN nennen annua
21. ction in this chapter Endoscope must feature the S symbol for STERRAD STERIS compatibility Leak Testing The ENT 4000 4500 Flexible Nasopharyngo Laryngoscope must be evaluated for possible leaks in the Control Body and or the Insertion Tube before immersion in any fluids The Leak Tester accessory should be used for this test Vision Sciences Leak Tester is required Follow the steps given in this chapter 20 ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual Reprocessing It is essential that gloves be worn when performing the leak test procedure in case the endoscope s Insertion Tube has been contaminated and requires further disinfection or sterilization An endoscope in this condition can present an infection control risk to the person s reprocessing the endoscope Attach the Leak Tester to the Endoscope Connect the Leak Tester to the endoscope s Vent Valve see Figure 5 1 Align the slot on the Leak Tester s connector with the pin on the Vent Valve then push down and rotate the connector clockwise until it locks Figure 5 1 Leak Tester Connection Leak Test Connection Components 1 Connector 2 Vent Valve 3 Alignment Pin align with slot in Connector Pressurize the Endoscope 1 Make sure that the Leak Tester s Pressure Relief Valve is closed by moving the button to the out position 2 Pump the hand bulb of the Leak Tester until the pressure gauge s needle reaches th
22. d or sterilized after cleaning Use caution when cleaning and then high level disinfecting or sterilizing the endoscope Recommended High Level Disinfection and Sterilization Procedures The following procedures have been determined by Vision Sciences Inc to be compatible with the ENT 4000 4500 Flexible Nasopharyngo Laryngoscope 24 High Level Disinfection in Glutaraldehyde All Vision Sciences endoscopes are validated for high level disinfection in 2 4 glutaraldehyde solutions Perform the High Level Disinfection Protocol described in this chapter Sterilization by Ethylene Oxide EtO Gas The endoscope may be Sterilized using a validated EtO protocol The acceptable processing parameters and procedures are given in the Ethylene Oxide EtO Gas Sterilization section on page 27 Sterilization by STERRAD The endoscope may be sterilized using a validated STERRAD protocol Refer to Table 5 1 on page 28 for the approved systems cycles suitable for use with this endoscope Sterilization by STERIS The endoscope may be sterilized using a validated STERIS protocol Refer to Table 5 1 on page 28 for the approved system suitable for use with this endoscope ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual Reprocessing Disinfection and sterilization methods not listed here may be harmful to the endoscope and exposure could result in extensive damage Please contact Vision Sciences Customer Service to determin
23. d to the endoscope s Distal Tip The other end of the Cable is attached to this Connector on the Control Body 3 Eyepiece Ocular Located at the top of the Control Body this feature allows the user to view the image directly Alternatively a standard video camera still photography system or teaching attachment can be connected to the eyepiece allowing the image to be displayed on a video monitor and or photographed 10 ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual Endoscope and Accessories 4 EndoSheath Interface Located at the base of the Control Body this component secures the disposable Slide On EndoSheath Technology to the endoscope 5 Identification Ring Includes the Serial Number which is a unique number identifying the endoscope and the S symbol which indicates the endoscope can be sterilized using a validated STERIS or STERRAD system The endoscope must feature this symbol on the ID ring in order for STERIS or STERRAD compatibility to apply Also includes a UL symbol Underwriters Laboratories which indicates the fiberscope is recognized as a component that can be used in tandem with add on components such as light sources and camera attachments 6 Vent Valve When the Vent Cap is connected here this Valve allows access to the interior of the endoscope for EtO or STERRAD Gas Sterilization and should be connected during transport The Vent Cap must be attached to this Valve prior
24. doscope should be stored in a dry well ventilated environment avoid high humidity direct sunlight and temperatures below 10 C or above 60 C Do not store the endoscope in its carrying case This case is only intended for endoscope transport it is not properly ventilated for storage Avoid storing the endoscope in heavily trafficked areas where there is a chance that it may sustain physical damage IM YEN The endoscope should NEVER be stored in areas where it could be exposed to liquids or environmental conditions such as high temperature humidity direct sunlight dust salt etc which could adversely affect its operation The endoscope should NEVER be stored in the presence of flammable or explosive gases or chemicals Disposal The equipment should be returned to Vision Sciences Inc for disposal Contact your local Vision Sciences representative or service facility for further information ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 29 7 Troubleshooting The information in this chapter is intended to help users diagnose problems that may occur during operation of the endoscope The following tables include some of the problems that could arise during operation possible causes for those problems and suggested corrective actions CAUTION If the problem persists even after the corrective action has been taken or a problem occurs that is not covered in the tables do not use the endoscope Co
25. e green zone Due to the size of the internal space of the endoscope 2 3 pumps of the hand bulb may be required to pressurize the entire chamber After the first pump the needle may drop out of the green zone and reach a stable position in the white zone Continue with additional pumps until the needle no longer falls back into the white zone ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 21 Reprocessing CAUTION Do not over pressurize the interior of the endoscope do not allow the needle to go above the green area on the gauge Over pressurizing the interior of the endoscope can lead to damage to the endoscope 3 Maintain the pressure for ten 10 seconds observing the position of the needle on the pressure gauge If the pressure decreases the Leak Tester endoscope connection may be loose or the Pressure Relief Valve on the Leak Tester may still be open and should be closed In this case remove and reattach the Leak Tester and repeat Steps 1 3 e f the pressure decreases after the connections are restored the endoscope has a damaged seal Do not continue to use the endoscope or immerse it in fluids in this condition Contact your regional distributor or the Vision Sciences Customer Service Center to arrange for evaluation and or repair When returning the endoscope follow the instructions given in Chapter 8 Warranty and Service 4 If the needle s position remains steady on the Leak Tester immerse the entire
26. e the compatibility of a disinfection or sterilization method not listed in this manual and or a complete list of functionally compatible agents Acceptable Reprocessing Materials Cleaning e e Intermediate Level Disinfection e High Level Disinfection e Sterilization Soft Material Lint Free Gauze 4x4 Enzymatic Cleaner Instrument Grade Detergent 70 Isopropyl Alcohol or 70 Ethyl Alcohol 2 4 Glutaraldehyde based solution EtO Gas Sterilization STERRAD 1005 NX 100NX STERIS System 1E Endoscope must feature the S symbol for STERRAD STERIS compatibility I ncompatible Methods The high level disinfection and sterilization chemicals and methods shown below are NOT compatible with the ENT 4000 4500 Nasopharyngo Laryngoscope DO NOT USE THEM as they could cause extensive damage to the endoscope If you have any questions regarding the compatibility of a given disinfection or sterilization method please contact your local distributor representative or the Vision Sciences Customer Service Center igh Level Disinfection and Sterilization Methods Chemical High Level Disinfection Chemicals Sterilization Methods DO Chlorines NOT Formaldehyde USE lodophors DO NOT Autoclave USE Ultrasonic ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 25 Reprocessing High Level Disinfection Protocol If the endoscope was determined to be free of leaks it
27. echnology installation and authorized disinfection protocols may pose an infection control risk and or cause equipment damage If training assistance is desired from either the manufacturer or a local distributor please contact Vision Sciences Customer Service at 800 874 9975 or 1 845 359 0276 Reprocessing The endoscope must be thoroughly cleaned disinfected and or sterilized before its first use and after each subsequent use This is the only way to ensure that a patient ready endoscope is used in every procedure See Chapter 5 Reprocessing for information on reprocessing equipment and procedures ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 3 Important Information Maintenance and Repair The endoscope contains no user serviceable parts never attempt to modify or repair it Doing so may cause further equipment damage and or compromise patient safety if the endoscope is subsequently used in a procedure The endoscope may only be serviced repaired at an authorized Vision Sciences Inc facility The endoscope should be thoroughly inspected before each procedure and should be periodically inspected to determine if there is damage or wear that requires attention Signal Words Information included in this manual to warn users of the possibility of patient injury and or equipment damage is signified by the Warning and Caution symbols below Warnings Cautions and Notes will appear thro
28. ed immersions may damage the outer coverings of the endoscope and allow fluid infiltration DO NOT place the endoscope in or near contaminated areas after it has been reprocessed Doing so can re contaminate the endoscope and require reprocessing to be repeated DO NOT place the endoscope in awkward or confining areas between procedures as this could result in equipment damage 6 ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 3 Endoscope and Accessories The Vision Sciences ENT 4000 4500 Flexible Nasopharyngo Laryngoscopes are designed to perform safe sterile and efficient endoscopy This equipment has been designed for the examination of the upper airway from the nasal passages to the vocal cords including the larynx With proper use the endoscope provides a thorough examination for more accurate diagnoses with minimal patient discomfort The ENT 4000 4500 Flexible Nasopharyngo Laryngoscope is shown in Figures 3 1 and 3 2 on pages 9 and 10 The endoscope does not have a working channel it contains three fiberoptic light bundles and a fiberoptic image bundle The ENT 4000 4500 Flexible Nasopharyngo Laryngoscopes are validated for use with the Slide On EndoSheath Technology The ENT 4000 4500 endoscopes can be used with or without the Slide On EndoSheath Technology The sterile disposable Sheaths are installed over the endoscope s Insertion Tube acting as a protective barrier to protect patients and use
29. endoscope in water and observe it for thirty 30 seconds Angulate the Distal Bending Section up and down while the endoscope is immersed as holes in the soft covering of the Distal Bending Section may not be evident while it is in a neutral position 5 A steady stream of air bubbles at a given location indicates a small leak in the endoscope that was not detected by the pressure gauge If a leak is detected the air pressure in the endoscope will prevent water from entering through the leak However immediately remove the endoscope from the water and do not immerse it in any more fluids L AUTION Do not continue to use an endoscope if leaks are detected Contact your local distributor or the Vision Sciences Customer Service Center to arrange for evaluation and or repair When returning the endoscope follow the instructions given in Chapter 8 Warranty and Service L NOTE Do not mistake the release of trapped air from the crevices on the endoscope s outer surface for a leak Trapped air can be released by tapping the endoscope gently after immersing it in water 6 The absence of air bubbles confirms that the endoscope is watertight Remove it from the water and open the Leak Tester s Valve 7 Make sure that the needle on the pressure gauge falls to zero 0 and disconnect the Leak Tester from the endoscope The endoscope can now be safely immersed in cleaning solutions CAUTION Failure to discharge depressurize the endoscope aft
30. ent using normally acceptable clinical practice prior to endoscope insertion If the endoscope will be inserted into the patient s mouth first place a bite block into the patient s mouth to prevent bite damage Lubricate the outside of the endoscope or Sheath if used before inserting the endoscope into the patient Vision Sciences Inc recommends that the endoscope or Sheath if used be lubricated with water or a water based lubricant just prior to insertion Introduce the endoscope into the patient using normally acceptable clinical practice Operate the Angulation Lever as necessary for advancement and observation When the procedure is completed withdraw the endoscope under direct visualization without holding the Angulation Lever This will allow the Distal Bending Section to move freely during withdrawal ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 5 Reprocessing The ENT 4000 4500 Flexible Nasopharyngo Laryngoscope can be used either with or without the Slide On EndoSheath Technology Vision Sciences Inc recommends the use of the Slide On EndoSheath Technology a sterile disposable protective covering which limits the need for elaborate chemical disinfection or sterilization procedures after every endoscopy procedure The complete system enables the user to implement a fast and effective method of reprocessing an endoscope and benefits both user and patient by providing an Insertion Tube
31. ent when reprocessing the endoscope or any of its components Appropriate protective equipment includes items such as a gown gloves and face and eye shields Complete and thorough reprocessing of the endoscope is the only way to ensure that a patient ready endoscope is used in all patient procedures Closely adhere to the reprocessing instructions given in this chapter Vision Sciences Slide On EndoSheath products for ENT endoscopes are covered by the following U S patents 6 350 231 6 530 881 6 733 440 These products may be covered by other U S or international patents ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 19 Reprocessing Reprocessing Steps The endoscope reprocessing procedure is made up of a series of steps each of which is essential to successful reprocessing Note The ENT 4000 4500 endoscope may only be leak tested with a Vision Sciences Endoscope Leak Tester Leak Testing The reprocessing procedure requires exposing the endoscope s surface to and immersing the endoscope itself in fluids If there is a leak in any part of the endoscope the internal components of the endoscope are vulnerable and will likely be damaged by fluid invasion Before cleaning disinfecting and or sterilizing the endoscope it is essential to perform a leak test to ensure the interior of the endoscope is resistant to fluid invasion e Cleaning Visible debris is removed from the surface of the endosco
32. er leak testing may place stress on the soft covering of the Insertion Tube potentially producing a rolling over of the rubber 22 ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual Reprocessing Cleaning Disinfection Sterilization Use of the Vent Cap CAUTION The Vent Cap is to be attached to the endoscope prior to all of the following procedures in order to prevent damage caused by changes in pressure and temperature 1 Gas Sterilization 2 Aeration 3 Shipping Remove the Vent Cap from the endoscope before the following 1 Patient Use 2 Immersion in Fluids FAI LURE TO COMPLY WITH THE ABOVE MAY RESULT IN DAMAGE TO THE ENDOSCOPE AND MAY VOI D THE PRODUCT WARRANTY Figure 5 2 Opening the Vent Valve Cleaning and Intermediate Level Disinfection After Slide On Endo Sheath Technology Use The Slide On EndoSheath Technology is intended for a single use only do not reuse it When the procedure is complete remove the Sheath from the endoscope and dispose of it Reusing the Sheath can present an acute infection control risk to the user and the next patient on whom the endoscope is used After a procedure in which the Slide On EndoSheath Technology was used Vision Sciences Inc recommends performing the following prophylactic cleaning and intermediate disinfection routine between endoscopic procedures ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 23
33. fiber bundles and internal components Excessive angulation or excessive pressure placed on the Angulation Lever may cause equipment damage Do not exert force to move the lever beyond its natural limits During the procedure the temperature at the distal end of the endoscope may exceed 41 C 106 F due to intense endoscopic illumination Surface temperatures over 41 C 106 F may cause mucosal burns Always use the minimum level of illumination necessary for adequate viewing Whenever possible avoid close stationary viewing and do not leave the distal end of the endoscope in close proximity to mucous membranes for a long period of time If using the Slide On EndoSheath Technology and image glare is present lower light source intensity until glare disappears ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 15 Preparation Inspection and Operation Preparation and nspection Follow the inspection steps listed below before connecting any equipment or using the system Do not use the equipment if abnormalities are present 1 Check the Insertion Tube for holes superficial cuts or abrasions 2 Lightly run your fingertips over the entire length of the Insertion Tube to confirm that it is smooth and does not exhibit looseness or bagging CAUTION Do not apply excessive pressure to the endoscope s Insertion Tube Doing so can damage the internal components 3 Check for full Distal Tip deflection by
34. go Laryngoscope User s Manual 13 4 Preparation Inspection and Operation If an abnormality is detected during endoscope preparation do not use the endoscope Refer to the tables in Chapter 7 Troubleshooting f the problem cannot be solved using the information in that chapter contact your regional distributor or Vision Sciences Customer Service Refer to Vision Sciences Service Information Chapter 8 Warranty and Service in this manual When using the Slide On EndoSheath Technology with the endoscope refer to the Instructions for Use that are shipped with the system These instructions will provide complete details on preparing installing and removing the disposable Sheath The Slide On EndoSheath Technology is shipped sterile and intended for a single use only Do not reuse it When the procedure is complete remove the sheath from the endoscope and dispose of it Reusing the sheath can damage it and in turn cause endoscope damage In addition a reused sheath presents a marked infection control risk to the next patient If you are not using the Slide On EndoSheath Technology ensure that the endoscope has undergone the appropriate disinfection process Refer to Chapter 5 Reprocessing for compatible reprocessing methods and procedures IM YE E EIE Avoid excessive bending or twisting of the endoscope s insertion tube particularly at the distal end While the tube is designed to bend excessive pressure can damage the
35. ibed in Chapter 5 Reprocessing Shipping contaminated equipment could present an acute infection control risk for those handling the endoscope both during shipping and at Vision Sciences Inc If the ENT 4000 4500 Flexible Nasopharyngo Laryngoscope has been used in a Clinical setting but cannot be disinfected before shipping place a red biohazard label on the shipping container to indicate that the contents are contaminated in accordance with OSHA standards 29 CFR 1910 1030 Observe the following precautions before shipping the endoscope to Vision Sciences Inc 1 Attach the Vent Cap to the endoscope s Vent Valve in preparation for shipping 2 If the endoscope has a leak or tear or fails the leak test or for some other reason cannot be disinfected properly as described in Chapter 5 Reprocessing wipe the endoscope down with 70 alcohol to remove debris Indicate on the outer package that the contents are contaminated 3 Ship the endoscope to Vision Sciences Inc in its carrying case Place the carrying case inside a corrugated box containing protective shipping material to prevent damage during shipment Regardless of warranty status all shipping charges to and from an authorized Vision Sciences Inc facility are the responsibility of the customer Ship the endoscope to the following address Vision Sciences Inc 40 Ramland Road South Orangeburg NY 10962 USA RGA L NOTE The customer will be contacted and advised
36. lassified Medical Equipment Before using any additional equipment confirm that it complies with the appropriate end product safety standard such as IEC 60950 1 and the Standards for Medical Electrical Equipment UL 60601 1 or IEC 60601 1 Never drop the equipment or subject it to severe impact as it could compromise the functionality and or safety of the equipment or system Should the equipment be mishandled or dropped do not use it Immediately return it to an authorized Vision Sciences service facility for inspection and repair NOTE The Vision Sciences ENT 4000 and ENT 4500 Flexible Nasopharyngo Laryngoscopes and Slide On EndoSheath Technology are latex free products Do not use this equipment in the presence of a flammable anesthetic mixture containing air oxygen or nitrous oxide There is a possibility of fire or explosion The ENT 4000 4500 is not intended to be used with electrosurgical devices If any of the component of the endoscopic system malfunction during the procedure or if the endoscopic image is lost or compromised immediately move the endoscope s Distal Bending Section into the neutral position and slowly withdraw the endoscope from the patient Using an endoscope that is not functioning properly could cause patient injury and or further damage to the equipment Always wear appropriate personal protective equipment when using the endoscope and or sheath such as a gown gloves and face and eye shields
37. ll sterilize the device to a sterility assurance level SAL of 10 Prior to EtO Gas Sterilization the endoscope must be leak tested and completely cleaned and dried according to the High Level Disinfection Protocol IM YEN Failure to properly clean the endoscope may inhibit the EtO Gas Sterilization process Prior to Gas Sterilization the Vent Valve must be opened as shown in Figure 5 2 on page 23 to accommodate the heat and pressure changes of the sterilization process To open the Valve press the red Vent cap onto the Vent Valve of the endoscope and rotate it clockwise until it is seated and locked After EtO Gas Sterilization Effective aeration must be completed after EtO gas sterilization Vision Sciences Inc recommends following the instructions for use supplied by the manufacturer of the gas sterilizer and that a biological indicator be used to confirm effective sterilization ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 27 Reprocessing STERRAD and STERI S Sterilization Prior to STERRAD and STERIS Sterilization the endoscope must be leak tested cleaned and dried as described in this chapter Refer to the STERRAD or STERIS Sterilization User s Manual for complete details on instructions for use IM YER E E E Failure to properly clean the endoscope may inhibit the STERRAD or STERIS sterilization process MANDAN The Vent Cap must be attached for the STERRAD sterilization
38. n eee 24 Recommended High Level Disinfection and Sterilization Procedures 24 incompatible Methods ea d e be RR e EMEN RA RHENUM SEU EAR BIS RUN 25 High Level Disinfection Protocol 26 A ee ANA on ere LN Eau 26 High Level DISII C OT oe e cte aereo Ae 26 bie 26 Ethylene Oxide EtO Gas Sterilization sese 27 STERRAD and STERIS Sterilization e ee rod aco dodo eine 28 6 Care and Storage site e UU DA O 29 poc 29 Disposal sr a 29 7 Kae pesi MP 31 8 Warranty and Service eio cc esos as 35 Watranty LITO MALO n recor tito ebore iip e rose aat A n o ico det tec d 35 Vision Sciences Service Information esssseeeen nnn 35 Shipping to Vision Sciences ING aro e Ero id t eee 36 PPP O 37 Specification S sans 37 Infection Control Information ss line 38 iv ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual Table of Contents Index of Figures Figure 3 1 ENT 4000 4500 Nasopharyngo Laryngoscope essneesnsenennnenenennnnnnn 9 Figure 3 2 ENT 4000 4500 Nasopharyngo Laryngoscope Control Body 10 Figure 3 3 Light Source Adapters Light Guide Sleeves sss 13 Figure 5 1 Leak Tester Connection ns 21 Figure 5 2 Opening the Vent Van it 23 Index of Tables Table 3 1 ENT 4000 4500 Nasopha
39. ng so 12 may reduce the operational safety of the system and could cause patient and or user injury For all accessories confirm that the safety certifications have been performed in accordance with the appropriate standard IEC 60601 1 and or IEC 60601 1 1 Use of accessories not specified in this manual or sold by Vision Sciences Inc may result in increased electromagnetic emissions or decreased immunity of the equipment or system Light Sources BLS 1000 Battery Powered Light Source An LED light source that allows for endoscopic illumination without a light guide cable Refer to Chapter 4 Preparation Inspection and Operation for proper set up and operation information The ENT 4000 4500 Endoscope is designed to be used with the BLS 1000 Battery Powered Light Source Light Guide Cables Additionally the ENT 4000 4500 Endoscope is designed to be compatible with various light sources when using the detachable Light Guide Cable To ensure proper mating with the selected light source be sure that the appropriate Light Guide Sleeve is securely threaded onto the Light Guide Cable Refer to Figure 3 3 for a complete list and diagrams of the available Light Guide Sleeves Add On Camera System The ENT 4000 4500 Endoscope features a rigid style eyepiece compatible with most manufacturers Add On Camera Systems Ensure that the Camera System s coupler is designed for a rigid style eyepiece If it is not please co
40. ntact Vision Sciences Inc for compatibility assistance Leak Testing The ENT 4000 4500 Endoscope may only be leak tested with a Vision Sciences Endoscope Leak Tester Reprocessing The ENT 4000 4500 Endoscope may be reprocessed by a variety of methods Refer to Chapter 5 Reprocessing for the accessories that will be used when reprocessing the endoscope Contact Vision Sciences Customer Service for advice on compatibility issues ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual Endoscope and Accessories Light Source Adapters Light Guide Sleeves The following Light Guide Sleeves are available to adapt Vision Sciences endoscopes for use with other manufacturers light sources when using a Detachable Light Guide Cable INIA MINA Using an incorrect or incompatible adapter could result in impaired operation and viewing and could cause damage to the endoscope light guide cable and or light source LIGHT GUI DE SLEEVE DI AGRAM CATALOG NUMBER amp COMPATIBLE LIGHT SOURCES 06 6019 Vision Sciences HLS 1500 XLS 3000 Circon and ACMI Light Sources 06 6009 Vision Sciences LS 150 and Pentax Light Sources 06 6044 Olympus Light Sources 06 6020 Smith Nephew Gyrus and Richard Wolf Light Sources 06 6029 Machida Light Sources 06 6023 Karl Storz Light Sources Figure 3 3 Light Source Adapters Light Guide Sleeves ENT 4000 4500 Flexible Nasopharyn
41. ntact Vision Sciences Inc for repair and or service using the information given in Chapter 8 Warranty and Service ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 31 Troubleshooting PROBLEM PROBABLE CAUSE SUGGESTED ACTION Angulation feels stiff Angulation alignment is no longer up down Loss of angulation Cloudy or foggy images when the endoscope is unsheathed Loss of illumination Damaged Distal Bending Section causing impaired angulation Insertion Tube has become twisted Angulation wires have been stretched or broken during use Patient debris or other material on the Objective Lens Fluid incursion into the endoscope s optical system The Lens at the Distal Tip has become damaged Patient material or other substance on the Light Guides Light Intensity is set too low Damaged light guide fiber bundles Return the endoscope to Vision Sciences Inc for repair Refer to Chapter 8 Warranty and Service Return the endoscope to Vision Sciences Inc for repair Refer to Chapter 8 Warranty and Service Return the endoscope to Vision Sciences Inc for repair Refer to Chapter 8 Warranty and Service Clean the Objective Lens with an alcohol prep pad to remove material or stain Excess staining may not be correctable and the lens may require replacement Return the endoscope to Vision Sciences Inc for repair Refer to Chapter 8 Warranty and Service
42. pe in this procedure which uses water and an instrument grade detergent When the Slide On EndoSheath Technology is used and inspection after the procedure confirms that the Sheath was not compromised surface cleaning and intermediate level disinfection of the endoscope is sufficient to prepare it for the next procedure e Intermediate Level Disinfection After use with EndoSheath Technology and proper cleaning the endoscope should undergo intermediate level disinfection For the complete routine see Cleaning After Slide On EndoSheath Technology Use on page 23 For procedures without utilizing the EndoSheath Technology intermediate level disinfection is not an adequate level of reprocessing e High Level Disinfection For procedures where the endoscope comes in direct contact with the patient or following any procedure during which the user suspects the endoscope became contaminated it is necessary to immerse the endoscope in a high level disinfectant Sterilization is also recommended See the High Level Disinfection Protocol and Sterilization section in this chapter e Sterilization In addition to high level disinfection the endoscope may be sterilized using ethylene oxide EtO gas Following sterilization the endoscope must be thoroughly aerated to ensure that all EtO gas residues have been removed The endoscope may also be sterilized using a validated STERRAD or STERIS system Refer to the STERRAD STERIS se
43. performed by an independent laboratory per FDA required guidelines All Slide On EndoSheath units undergo a rigorous Quality Assurance process to ensure the utmost in product quality and efficacy Please contact Vision Sciences Customer Service for a detailed information packet regarding Infection Control and the Slide On EndoSheath Technology 1 Viral challenge testing performed with bacteriophage 27 nanometers in size per FDA guidance 38 per FDA Clearance requirements barriers must be tested by the guidelines set within the FDA Guidance for Manufacturers Seeking Marketing Clearance of Endoscope Sheaths Used as Protective Barriers ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual VISION SCIENCES Vision Sciences I nc 40 Ramland Road South Orangeburg NY 10962 USA Phone 845 359 0276 or 800 874 9975 International 1 845 359 0276 Fax 845 365 0620 E Mail info visionsciences com www visionsciences com For additional product information or questions pertaining to sales and service please contact the local distributor or the manufacturer MedPass I nternational Ltd Windsor House Barnett Way Barnwood Gloucester GL43RT United Kingdom C 0843 2009 2012 Vision Sciences Inc Vision Sciences EndoSheath and Slide On are registered trademarks of Vision Sciences Inc 12 12 11759 EN Rev E 22412
44. rs from the spread of potentially pathogenic materials Be sure to handle the endoscope with care during use reprocessing and storage The fiberoptics are comprised of thin glass fibers which can be damaged by physical trauma extreme temperatures high humidity or fluid invasion of the endoscope ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 7 Endoscope and Accessories Inspect the Standard Set Do not use any equipment that is observed to be damaged or WARNING excessively worn Doing so could lead to patient injury and or further damage to the equipment When the endoscope is received from Vision Sciences Inc immediately confirm that the items listed in Table 3 1 below have been shipped and inspect them for damage If any item is missing or damaged do not use the endoscope Contact Vision Sciences Inc to obtain a replacement part ENT 4000 NASOPHARYNGO LARYNGOSCOPE STANDARD SET CATALOG NO 02 4202 07 3060 07 6015 07 6180 DESCRIPTION ENT 4000 Endoscope Light Guide Cable 1 8m Vent Cap Vision Sciences ENT 4000 4500 Carrying Case ENT 4000 4500 User s Manual this document ENT 4500 NASOPHARYNGO LARYNGOSCOPE STANDARD SET 02 4502 07 3060 07 6015 07 6180 ENT 4500 Endoscope Light Guide Cable 1 8m Vent Cap Vision Sciences ENT 4000 4500 Carrying Case ENT 4000 4500 User s Manual this document OPTIONAL ITEMS AND ACCESSORIES NOT SHI PPED WITH ENDOSCOPE 07 6160 07 616
45. ryngo Laryngoscope Standard Sets 8 Table 5 1 STERRAD and STERIS Validated Systems Cycles eees 28 Table 7 1 Troubleshooting ss ass ine 32 TO 31 ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual v 1 Symbols and Terms Symbols The symbols listed below can be found on the ENT 4000 4500 Flexible Nasopharyngo Laryngoscope and on other components of the endoscopic system A _SN CE va U D E Type BF applied part 1 Safety degree specified by IEC 60601 1 Alerts the user to the presence of important operating maintenance and service instructions Refer to and become familiar with the user s manuals for all equipment used in the procedure Serial number of the endoscope Equipment bearing this mark has been designed tested and certified as essentially compliant with all applicable European Union EU regulations and recommendations Up position for the angulation lever Down position for the angulation lever Underwriters Laboratories Component Recognition Mark STERIS and STERRAD Reprocessing Compatibility Refer to Chapter 5 Reprocessing Endoscope must feature the S symbol for compatibility to apply Terms The following terms are used throughout this User s Manual a Laryngoscope Endoscope or ENT Scope Refers to the Vision Sciences ENT 4000 4500 Nasopharyngo Laryngoscope o Sheath Refers to
46. to EtO or STERRAD Gas Sterilization and prior to shipping The valve is also used as a Leak Tester Connector for Leak Testing 7 Distal Bending Section Deflects up and down when the Angulation Lever is actuated by the user 8 Distal Tip The terminating point of the image fiber bundle Objective Lens and the light guide fiber bundles Light Guides 9 Control Body This segment allows physician control over endoscopic functions 10 Insertion Tube This component along with the Distal Tip is the part of the endoscope that is inserted into the patient 11 Diopter Adjustment Ring Located on the Control Body this ring turns clockwise or counterclockwise to adjust the image until the image is clear When a video camera still photography systems or teaching attachment is used the white dot on the control body should be aligned with the white dot on the Diopter Adjustment Ring When using an add on camera use the Focus Ring on the camera to adjust focus instead of the Diopter Adjustment Ring Not Shown in Diagram Detachable Light Guide Cable Standard 1 8m cable shipped with endoscope Light Guide Sleeve Adapts the Light Guide Cable to make it compatible with different light sources ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual 11 Endoscope and Accessories Accessories Do not use any accessories that are not in compliance with the WARNING equivalent safety requirements of this equipment Doi
47. ughout this manual carefully read and follow all statements WARNING Alerts the user to situations which if not avoided could result in death or serious injury CAUTION Alerts the user to situations which if not avoided could result in moderate or minor injury to the user or patient It is also used to alert the user to conditions and actions that could cause equipment damage L NOTE Indicates additional helpful information Important Safety Precautions The following precautions should always be exercised when using the endoscope and all medical equipment to ensure safety to all involved parties user s patient s etc They are summarized here in the order of the stages of the endoscope s use Preparation Inspection and Assembly WARNING Carefully inspect all equipment before using it in a procedure and do not use any equipment that is damaged or excessively worn Doing so could lead to patient injury and or further damage to the equipment If inspection reveals difficulty in articulation of the endoscope s Distal Bending Section the endoscope may be damaged Do not use the endoscope in this case Contact your local distributor or call the Vision Sciences Customer Service Department 4 ENT 4000 4500 Flexible Nasopharyngo Laryngoscope User s Manual CAUTION 4 During Use Important I nformation All devices that are connected to the ENT 4000 4500 Flexible Nasopharyngo Laryngoscope must be C
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