User Manual - Welch Allyn
Contents
1. Before any attempt is made to sterilize the fiberscope the complete cleaning procedure as described elsewhere in this manual must be completed Only the user can assure that sterilization techniques like those described here will accomplish the desired clinical effect IMPORTANT WARNING Never place the fiberscope in a steam autoclave Never subject the fiberscope to ultrasonic cleaning methods Ethylene Oxide ETO Gas Sterilization can be performed on the RL 150 Rhinolaryngoscope provided the following special instructions which differ from other endoscopes are followed to ensure proper performance of the instrument 1 The endoscope must first have been properly cleaned and thoroughly dried according to the instructions in this manual a The Red ETO Gas Sterilization Venting Cap MUST be on securely b Temperature must not exceed 55 C 131 F c Pressure must not exceed 24 PSI d Humidity must not exceed 50 e Sterilization procedure must not exceed 4 hours 12 Sterilization And Aeration continued 2 Following ETO Gas Sterilization aeration time of 72 hours at room temperature is required 3 Aeration Chamber To shorten the aeration time to 12 hours an aeration chamber may be used provided the temperature does not exceed 55 C 131 F NOTE Prior to placing the RL 150 Rhinolaryngoscope in an aeration chamber the Red ETO Gas Sterilization Vent Cap MUST be on securely Cold Sterilization For tho2. RL 150 Rhinolarvngoscope and LX 150 Light Source Operating Instructions i rN WA Welch Allyn WA Welch Allyn Thank you for purchasing the Welch Allyn RL 150 Rhino laryngoscope The operating and maintenance instructions found in this manual should be followed to ensure many years of accurate and reliable service Please read these instructions thoroughly before attempting to use your new RL 150 Rhinolaryngoscope Warning The user of the RL 150 Rhinolaryngoscope should be thoroughly trained in the medical procedures appropriate to the equipment Furthermore time should be taken to read and understand these instructions before perform ing any procedures Failure to do so may result in injury to the patient and or damage to the instrument While this manual describes the recommended protocol for inspecting and operating the equipment it does not outline procedure techniques Only physicians trained and versed in the procedure of nasopharynlaryngoscopy should use this equipment Table of Contents Specia iS eniinn aan aE EE EN K bi iebijit 1 Component lied see 1 Nomencla ti i A 2 Pror to minal US siris ika A 3 Systemet UP seare A E E 3 System MSS COU ibidu ikkastigat e d 4 i cn ee ecto astern ice cache EAA ELERE 6 Cl anih A 7 Di in COME moria 10 Sienlizanon and Aeration gasinscinssncrsnsntsanintedediaesiinadiannataotientecrmmennanane 12 SMTA aba de ki l aa 13 Specifications Angle of View esseere 75 D
3. ce the outer cover of the bending section may be excessively stretched Dry the ocular lens with a cotton tip swab Using the Disinfection Tray 1 Fill the clear tube of the disinfection tray with disinfectant up to the black indicator dot 2 Slide insertion tube into the disinfection solution and position the instruments control section securely in the space provided on the disinfection center 3 Carefully wind the umbilical cord and place next to the tray as illustrated 4 After soaking for the disinfec tion solution manufacturer s recommended time remove the instrument from disinfec tion tray 5 Immerse the insertion tube in clean water to rinse 6 Remove instrument from water and dry surfaces of the instrument thoroughly 7 Hang scope with insertion tube straight to dry 11 Disinfection continued Disinfecting Solutions Specific reference to brand names is not an endorsement of their efficacy as a disinfecting solution Tests have shown these solutions to be compati ble with the RL 150 Rhinolaryngoscope providing the manufacturer s direc tions are followed Solution Brand Name Source Usage Glutaraldehvde Cidex 14 Dav J amp J Follow manufacturers 290 Medical instructions Glutaraldehvde Wavicide 01 Wave Energy Follow 2 Systems manufacturer s instructions Glutaraldehyde Metricide Metrex Follow manufacturer s 14 Day 2 Research Corp instructions Sterilization and Aeration
4. e while drying since the outer cover of the bending section may be excessively stretched Dry the ocular lens with a cotton tip swab Disinfection Before any attempt is made to disinfect the fiberscope the complete clean ing procedure as previously described in this manual must be completed Complete Immersion Before complete immersion in any disinfecting solution the instrument should be LEAK TESTED as described elsewhere in this manual Before immersion the Red ETO vent cap MUST be removed 1 Immerse the instrument in a basin filled with a compatible disinfection solution WARNING Using a disinfectant other than those tested for compati bility with the instrument may result in severe damage to the instru ment Contact Welch Allyn Customer Service with any questions regarding solution compatibility 10 Disinfection continued 2 The instrument should remain in contact with the disinfecting solution for the time period recommended by the manufacturer of the solution and accepted by the user as appropriate 3 After the instrument has been in contact with the disinfecting solution for an appropriate time remove the instrument from the solution 4 Place in a basin filled with clean water to rinse all residual disinfecting solution from the instrument Remove instrument from water 5 Gently dry all external surfaces of the instrument with soft gauze or towel Do not put tension on the insertion tube while drying sin
5. e spot a leak is indi cated Immediately remove the scope from the water DO NOT use the scope Contact Welch Allyn Customer Service immediately 3 After removing the instrument from water release the air pressure by opening the pressure release valve on the handle of the leakage tester After the gauge indicates zero disconnect the leakage tester from the scope Cleaning continued NOTE Never connect or disconnect the leakage tester under water This will allow water into the instrument and leakage tester 4 If leakage was discovered during stage two thoroughly dry the instru ment and contact Welch Allyn Customer Service 5 If no leakage was discovered during stage two you may proceed with cleaning and disinfection of the instrument as outlined in the following pages Cleaning Procedure 1 Prepare a basin with warm water and a mild detergent Immerse the instrument in the solution 2 Thoroughly but gently wash the entire outer surface of the instrument with a soft brush or guaze pad Remove the instrument from the basin NOTE Do not squeeze or severely bend the insertion tube Do not use any abrasive materials Be careful to avoid damage to the ocular and distal lenses 3 Place in basin of clean water Thoroughly rinse the outside of the instrument 4 Gently dry all external surfaces of the fiberscope with soft gauze ora towel DO NOT put tension on the insertion tube of the endoscop
6. ent O pin and clockwise rotation R OS 2 Tum the gauge faceplate to zero on the pressure indicator Cleaning continued 3 Pressurize the scope by pumping the hand bulb until the indicator on the gauge is in the green zone DO NOT pressurize into the red zone it may cause serious damage to the scope 4 Observe the gauge pressure to determine if the indicator remains in the green zone If the indicator drops from the green zone rapidly a major leak may be indicated NOTE Be certain that the pressure release valve on the handle of the leakage tester has been tightened DO NOT IMMERSE the entire instrument if the gauge indicator does not remain in the green zone Instead contact Welch Allyn Customer Service Stage Iwo Test After determining the absence of any major leak in stage one testing the instrument may be immersed in clean water to test for loss of integrity in the watertight construction 1 With the leakage tester securely attached to the instrument and the scope pressurized with the gauge indicator in the green zone the entire scope may be immersed in clean water NOTE Only the leakage tester connector and a small portion of its tubing should be immersed Never immerse the entire leakage tester 2 Observe the instrument carefully A few bubbles may initially rise from recessed areas of the scope This is normal If a continuous stream of bubbles is observed from the sam
7. epth of Field 3 50 mm Diopter eee 42 to 8 diopter Tip Deflection LD vascesasucssohedbapunabazavipeenatined 130 DOWD ives ssissstestivssversxasescten 130 Components Distal Rigid Portion Diameter 008 3 4 mm Insertion Tube Diameter 3 5 mm Insertion Tube lt r 65050 RL 150 Rhinolaryngoscope 65015 LX 150 Adaptor 65008 Eyepiece Cap 65012 ETO Vent Cap Nomenclature RL 150 Rhinolaryngoscope Diopter Adjustment fE EZ z Ring Switch Air Output Connector Illumination Control Water Bottle Endoscope Bracket Connector Port Light ETO Guides Vent Objective Connector Lens Distal Tip Bending Section Light Guide Terminal Prior to Initial Use Before set up and inspection of the equipment check all components received against the list of components see Components section pg 1 to verify complete set If parts are missing please notify Welch Allyn Review the Nomenclature Set Up Operation and Cleaning Disinfection sections to become familiar with the equipment Specifically Inspect Rhinolaryngoscope Insertion Tube For tears cuts dents bubbles bumps Control Section Test angulation lever bending section deflection to assure smooth articulation Light Source Cabinet For any dents scratches or other surface abnormalities System Set Up Rhinolaryngoscope The No 65015 adaptor is coupled to your RL 150 Rhinolary
8. lumination intensity control Clockwise rotation will increase illumination output Counter clockwise will decrease illumination NOTE If your light source has an air pump built in the air pump is not used for Rhinopharynlaryngoscopy WARNING The risk of thermal injury exists whenever fiber optic instruments are used with high intensity light sources The risk of injury is greatest A During close stationary observation and or prolonged close contact with mucosa B When the fiberscope is advanced slowly through a narrow lumen Close stationary viewing should be avoided and the level of illumination should be limited to the level necessary for adequate visualization Operation Procedure The methods and techniques of rhinopharynlaryngoscopy are well defined and documented Endoscopy training seminars and programs are also in existence No attempt is made in this manual to outline the medical procedure or techniques of rhinopharynlaryngoscopy The physician should always take care to understand the clinical background of each patient and the contraindications of the procedure Preparation Before Insertion Note The endoscope should be properly cleaned and disinfected or sterilized prior to the first use and all subsequent uses Only by adhering strictly to the steps outlined elsewhere in this manual can the user be assured of the effectiveness of the processes 1 Gently clean the objective lens wi
9. lyn 4341 State Street Road Skaneateles Falls NY 13153 315 685 4560 800 535 6663 Printed in U S A Part No 650033 Rev C
10. ngoscope endoscope connector terminal when shipped from Welch Allyn In the event that the adaptor should become uncoupled Steps 1 2 below should be undertaken Otherwise proceed to Step 3 1 Place the No 65015 adaptor over the light guide terminal 2 Thread the adaptor on until snug against endoscope connector terminal Endoscope Connector Terminal SIAL O et RL 150 Umbilical LX 150 Cord Light 0 Adaptor Endoscope 65015 Connector Port 3 Insert the male end of the adaptor into the Light Source endoscope connector port Push until the ball detent in the light source clicks into place to ensure a secure fit System Set Up continued Light Source See Light Source Manual for complete instructions 1 Plug power cord into the receptacle on the back of the cabinet 2 Plug the remaining end into a properly grounded hospital grade AC outlet 3 Activate power and air switches to verify functionality of the lamp and pump NOTE The air pump that is built in to some light boxes is not used for Rhinolaryngoscopy System Inspection The following steps in addition to leak testing cleaning and disinfection should be repeated prior to every procedure to verify that the system is working If any problem is encountered immediately contact Welch Allyn Customer Service for assistance Insertion Tube Check the entire surface of the insertion tube for abnormalities such as dents wrinkles or cut
11. s Any indentation in a flexible shaft of the endoscope can cause damage to the internal mechanisms CAUTION To avoid further damage to the endoscope or the possibil ity of malfunction during a procedure do not use any instrument with outward signs of damage NOTE The distal end of the fiberscope must be protected against damage from impact Never apply excessive force by twisting or severely bending the insertion tube or bending section of the instrument System Inspection continued Inspection of Light Guides and Optics 1 With the light source lamp on hold distal tip approximately 40 mm from any printed surface Verifv light is being emitted from light guides dO 2 Hold eyepiece to your eye and rotate diopter ring until print is in focus Verify focus from 10 40 mm from surface Inspection of Umbilical Cord 1 Check the umbilical cord for cracks dents crushed and twisted areas 2 Verify that the endoscope connector terminal s light guide terminal fitting is tight and does not move when light pressure is applied NOTE Instrument should be cleaned and disinfected or sterilized prior to every use Follow steps starting on pages 7 and 10 Inspection of Light Source 1 Activate power switch This will start the lamp and cooling fan CAUTION Do not look directly into the endoscope connector port when activating the light source 2 The output of the light source is con trolled by the il
12. se situations where Ethylene Oxide ETO Gas Sterilization capa bility is not available Welch Allyn endoscopes have been designed to withstand immersion in Glutaraldehyde solution for a maximum of 10 hours to achieve cold sterilization Never fully immerse the instrument without first conducting the leakage test procedure as described else where in this manual to verify the watertight integrity of the scope WARNING Never exceed 10 hour maximum immersion After 10 hour immersion the instrument must be thoroughly rinsed to remove all residual Glutaraldehyde solution After being thoroughly rinsed the instrument must be allowed to breathe balancing internal and external humidity by attaching the Red ETO Venting Cap Storage Thoroughly dry the instrument and accessories Place in the wall hanger 1 During storage the insertion tube of the scope and the light guide should be kept as straight as possible 2 The storage area should be dry and airy Avoid high humidity high temperature and areas exposed to direct sunlight 3 The Red ETO Venting Cap should be placed on the scope to allow the scope to breathe balancing internal and external humidity while it is in storage Service Customer Service Telephone Assistance 315 685 4560 For repairs on the PAE RL 150 Rhinolaryngoscope ship to AN Welch Allyn Technical Service 4 4341 State Street Road Skaneateles NV 13153 Welch Allyn 13 WA Welch Al
13. th a cotton tip applicator moistened with alcohol 2 Gently wipe the insertion tube with gauze dampened with clean water 3 The individual user should adjust the diopter adjustment ring to make sure that a clear view can be obtained No further adjustment should be necessary during a procedure 4 If desired apply a water soluble lubricant to the insertion tube The objective lens must be kept free of the lubricant which would obstruct your view NOTE Do not use lubricants that are petroleum based as these will deteriorate the rubber covering the bending section Insertion and Operation 1 Always insert the instrument slowly under direct vision 2 Once lumen is visible adjust the light intensity control on the light source to desired setting Note The distal tip of the rhinolaryngoscope may become warm if in continuous operation with the illumination set too high this can damage the mucosa Use the lowest light setting possible 3 Tip deflection must be performed under direct observation Deflect the bending section gently using minimal force 4 When withdrawing the instrument pull back slowly under direct obser vation Do not remove the instrument blindly Cleaning Endoscopic instruments should be cleaned immediately after each use Endoscopes are delicate and will degrade if not cleaned promptly due to the effects of blood mucous etc The steps outlined on the following pages have been tested and verified
14. to have no damaging effects Therefore these procedures should be adhered to Supplies Needed For Cleaning Large basin of water Disposable gloves a Cleaning solution soap solution Leakage tester 65009 O Gauze pads Soft scrub brush af Immediately After Procedure TA 1 Immediately after removing the instrument from the patient gently wipe all blood mucous and debris from the insertion tube with a gauze pad moistened in clean water 2 Tum off the power switch on the light source sien Disconnect endoscope from light source by grasping endoscope con nector terminal adaptor and pulling back gently Cleaning continued Perform Leak Test Procedure The leakage test allows for a simple two stage test of the water tight integrity of the instrument Air pressure is introduced into the interior of the instrument by means of a hand pump The instrument is then checked for pressure decay via a gauge and then visually Scope Connector Leakage Tester Stage One Test BEFO RE IMMERSION the instrument should be tested for any major loss of integrity in its watertight construction example major tear in the bending section 1 Secure the Leakage Tester to the ETO vent connector on the instrument s endoscope connector D terminal The Leakage Tester connector and the ETO vent connector MUST be dry before l securing Proper connection will require alignment of the air v
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