Cleaning, Disinfection, and Sterilization Instructions
Contents
1. Caution Do not saturate the rheostat area Excess solution entering the assembly may damageinternal components in the handle 1 Using CaviWipes wipe the surface to remove all gross debris 2 Using a soft bristle brush scrub the handle for a minimum of 5 minutes then repeat wipe with a second CaviWipe 3 Allow the handle surface to dry for a minimum of 10 minutes Intermediate Level Disinfection 1 Follow the Cleaning instructions above 2 Using CaviWipes wipe the handle and keep wet with CaviWipe solution for a minimum of 5 minutes 3 Allow the handle surface to dry for a minimum of 10 minutes 9 10 ENGLISH Cleaning Disinfection and Sterilization Instructions2. Using a 60 cc syringe deliver 60 cc of the cleaning solution to the inside of the bulb through the hose end 5 Lightly agitate the solution inside of the bulb for a minimum of 5 minutes 6 Empty the cleaning solution from the bulb 7 Using a 60 cc syringe deliver 60 cc of sterile water into the bulb through the hose end 8 Lightly agitate the water inside of the bulb for a minimum of 5 minutes 9 Empty the rinse water from the bulb and repeat rinse with sterile water 5 more times 10 The bulb must be dried sufficiently Any moisture inside the device could occlude the insufflation bulb filter if used or dilute disinfection or sterilization agents One way to achieve this is to hang the bulb with the tube down for a minimum of 24 hours Disinfection 1 Follow steps 1 through 9 of the Cleaning instructions 2 Using CIDEX OPA 0 55 OPA 14 day maximum reuse soak the item for a minimum of 12 minutes 3 Perform 3 sequential rinses of the bulb for a minimum of 5 minutes each with sterile water 4 Using aclean 60 cc syringe deliver 60 cc of the CIDEX OPA solution to the inside of the bulb through the hose end 5 Lightly agitate the solution inside of the bulb for a minimum of 12 minutes 6 Empty the solution from the bulb 7 Using a clean 60 cc syringe deliver 60 cc of sterile water into the bulb through the hose end 8 Lightly agitate the water inside of the bulb for a minimum of 5 minutes 9 Empty the rinse water f
3. minute cycle Validate any other sterilization equipment 8 ENGLISH Cleaning Disinfection and Sterilization Instructions Power Supply p Part Numbers 73305 73322 73324 73326 Caution Do not immerse the power supply in any solution or sterilize Doing so may damage the power supply and void the warranty Caution The power supply can only be wiped with a soft dry lint free cloth or scrubbed with a dry brush The following cleaning instructions apply to the Power Cord ONLY 1 Disconnect the power supply cord from the light handle 2 Disconnect the power supply from its wall receptacle Cleaning the Power Cord 1 Prepare an enzymatic detergent formulated for endoscopic instruments according to the manufacturer s instructions These instructions were validated using ENZOL CIDEZYME 2 Wet the cord with the cleaning solution 3 Using a soft bristle brush scrub the cord with the cleaning solution for a minimum of 5 minutes then rinse the cord with sterile water for 5 minutes Intermediate Level Disinfection of the Power Cord 1 Follow the Cleaning instructions above 2 Using CaviWipes wipe the cord and keep wet with CaviWipe solution for a minimum of 5 minutes 3 Allow the cord surface to dry for a minimum of 10 minutes Rigid Reusable amp Single use Sigmoidoscopes Anoscopes and Accessories ENGLISH Rechargeable Handle Rheostat lt Brightness Part Number 71000 A Control Cleaning
4. the Examination of the Hollow Viscera for additional guidance on reprocessing of these devices accessories Although this standard is for flexible endoscopes it contains information that can be applied to rigid endoscopes as well Caution U S federal law restricts this device to sale by or on the order of a physician or licensed healthcare practitioner This device should only be used by trained personnel Caution Perform reprocessing immediately after each use Caution Consult your facility s procedures and the reprocessing agents manufacturer s instructions for the agents reuse recommended Personal Protective Equipment and other safety precautions such as ventilation etc Caution Examine surfaces of all components for wear or damage after cleaning disinfection and or sterilization Caution For cleaning and or disinfection use brushes appropriate for the size of the endoscope channel parts connectors and orifices e g bristles should contact all surfaces Cleaning disinfection tools brushes etc should be single use or thoroughly cleaned disinfected and or sterilized between uses Caution Unless otherwise specified perform all reprocessing procedures at ambient room temperature Caution Clean and disinfect all devices or accessories per these instructions prior to returning to Welch Allyn e g for repair and service Caution Users are responsible to qualify any deviations from these procedures 2 ENGLISH Clean
5. Follow the Cleaning instructions above Perform one autoclave cycle that includes 6 minutes at 270 F 132 C and a cool down period of at least 15 minutes These instructions were validated using a gravity autoclave Validate any other sterilization equipment and load configurations Rigid Reusable amp Single use Sigmoidoscopes Anoscopes and Accessories ENGLISH 5 Insufflation System Do not disassemble this connection Part Number 30200 Caution Welch Allyn recommends the use of the Single Use Insufflation Bulb Filter 30210 for all applicable endoscopic procedures The filter does not eliminate the need to properly process the insufflation bulb with each use but restricts internal contamination and aspiration of fluids Caution Do not disassemble the insufflation bulb Caution The insufflation bulb may discolor after disinfection or sterilization without effecting performance Caution Do not autoclave insufflation system Damage will occur 6 ENGLISH Cleaning High Level Cleaning Disinfection and Sterilization Instructions Prepare an enzymatic detergent formulated for endoscopic instruments according to the manufacturer s instructions These instructions were validated using ENZOL CIDEZYME 2 Submerge the item in the cleaning solution 3 Using a soft bristle brush scrub the item submerged in the cleaning solution for a minimum of 5 minutes then rinse with sterile water for 5 minutes 4
6. WelchAllyn Advancing Frontline Care Rigid Reusable amp Singl Accessories Cleaning Disinfection e use Sigmoidoscopes Anoscopes and and Sterilization Instructions Mat i 103251 Ver B This document is made from 713512 Version B Welch Allyn Inc 4341 State Street Road Skaneateles Falls NY 13153 Tel 1 800 535 6663 or 1 315 685 4560 Fax 1 315 685 3361 www welchallyn com The CE mark on these products indicates that they are in conformity with the provisions of Council Directive 93 42 EEC European Regulatory Manager Medical Division Welch Allyn Ltd EC i KAL Navan Business Park Dublin Road Navan County Meath Republic of Ireland Tel 353 46 90 67700 Fax 353 46 90 67755 2009 Welch Allyn Inc All rights reserved No one is permitted to reproduce or duplicate in any form this manual or any part thereof without permission from Welch Allyn Welch Allyn assumes no responsibility for any injury to anyone or for any illegal or improper use of the product that may result from failure to properly use the product in accordance with the instructions cautions warnings or statement of intended use published in this manual Welch Allyn is a trademark of Welch Allyn Inc Metricide is a registered trademark of Metrex CaviWipes is a trademark of Metrex CIDEX OPA Sterrad CIDEZYME and ENZOL are registered trademarks of Advanced Sterilization Products a division of Johnson and Joh
7. a reprocessing procedure wipe the lamp with a soft dry lint free cloth Re attach the clean sleeve to the handle by screwing in a clockwise direction Re connect the power supply cord to the light handle and verify that the unit works by plugging it in If the lamp fails to illuminate follow the troubleshooting instructions located in light handle manual 700791 supplied with your handle Cleaning 73210 73211 and 73500 1 Prepare an enzymatic detergent formulated for endoscopic instruments according to the manufacturer s instructions These instructions were validated using ENZOL CIDEZYME Submerge the rectal light handle outer sleeve in the cleaning solution Using a soft bristle brush scrub the item submerged in the cleaning solution for a minimum of 5 minutes then rinse with sterile water for 5 minutes Wet the rectal light handle body and cord with the cleaning solution Using a soft bristle brush scrub the cord with the cleaning solution for a minimum of 5 minutes then rinse the cord with sterile water for 5 minutes Intermediate Level Disinfection 73210 73211 and 73500 Follow the Cleaning instructions above Using CaviWipes wipe all item surfaces and keep wet with CaviWipe solution for a minimum of 5 minutes Allow the item surface to dry for a minimum of 10 minutes Sterilization 73211 ONLY A Caution Autoclaving the light handle may reduce the product s functional life 1 2
8. ing Disinfection and Sterilization Instructions Rigid Sigmoidoscopes Anoscopes and Light Carrier 37023 Anoscope Sigmoidoscope Light Carrier Part Numbers Part Numbers Part Numbers 37019 38614 32010 32820 36019 37023 38619 32020 32830 38700 37027 38622 32410 33220 Suction Tube Part Numbers 38108 38900 32420 33620 38114 39614 32810 33830 30130 38119 39619 30140 38122 39622 Suction Tubes not illustrated Note For all steps remove obturator for separate cleaning and open viewing window Cleaning Caution Welch Allyn recommends the use of the Single Use Insufflation Bulb Filter Re 30210 for all applicable endoscopic procedures The filter does not eliminate the need to properly process the insufflation bulb with each use but restricts internal contamination and aspiration of fluids Prepare an enzymatic detergent formulated for endoscopic instruments according to the manufacturer s instructions These instructions were validated using ENZOL CIDEZYME Submerge the item in the cleaning solution Using a soft bristle brush scrub the item submerged in the cleaning solution for a minimum of 5 minutes then rinse with sterile water for 5 minutes High Level Disinfection 1 2 Follow the Cleaning instructions above Using CIDEX OPA 0 55 OPA 14 day maximum reuse soak the item for a minimum of 12 minutes Perform 3 sequential rinses of the item for a minimum of 5 minutes each with steri
9. le water Rigid Reusable amp Single use Sigmoidoscopes Anoscopes and Accessories ENGLISH 3 4 Allow the item to dry for 24 hours or until no moisture remains in the device Any moisture in the device could occlude the insufflation bulb filter Sterilization 1 Follow the Cleaning instructions above 2 Perform one autoclave cycle that includes 6 minutes at 270 F 132 C and a cool down period of at least 15 minutes These instructions were validated using a gravity autoclave Validate any other sterilization equipment and load configurations Light Handle Assembly and Handle Adapter e S Y Part Numbers 73210 and 73211 Part Number 73500 including 07800 U lamp including 03100 U lamp A WARNING Allow the lamp to cool for at least 5 minutes before handling Note Leave the lamp installed while reprocessing 73210 73211 and 73500 Assembly and Disassembly Instructions for 73210 and 73211 1 Disconnect the light handle from the power supply cord and the device 2 Unscrew the outer sleeve of the handle by turning it counterclockwise Rectal Light Handle Body and Cord CCW S i a Handle puter Sleeve 3 Follow one of the reprocessing methods described below Caution Do not immerse the rectal light handle body and cord in any solution Doing so may damage the rectal light handle body and cord and void the warranty 4 ENGLISH Cleaning Disinfection and Sterilization Instructions After performing
10. nson Company USA 1 800 535 6663 Australia 61 2 9638 3000 1 315 685 4560 Canada 1 800 561 8797 China 86 21 6327 9631 European Call Center 353 46 90 67790 France 33 1 60 09 33 66 Germany 49 7477 9271 70 Japan 81 3 3219 0071 Latin America 1 305 669 9003 Netherlans 31 157 505 000 Singapore 65 6419 8100 South Africa 27 11 777 7555 United Kingdom 44 207 365 6780 Sweden 46 85 853 6551 Cleaning Disinfection and Sterilization Instructions Rigid Reusable amp Single use Sigmoidoscopes Anoscopes and Accessories ENGLISH 1 ENGLISH Intended Use The Welch Allyn Rigid Reusable amp Single Use Sigmoidoscopes and Anoscopes are used to illuminate and facilitate the examination of the rectal and anal cavity The instrument also provides a means of entry for surgical instruments into the rectal and anal cavity Endoscopes and the insufflation system are categorized as semi critical devices requiring high level disinfection and the illumination system is categorized as a non critical device requiring low level disinfection according to the Multi society guideline for reprocessing flexible gastrointestinal endoscopes published by Gastrointestinal Endoscopy volume 58 No 1 2003 and simultaneously in Infection Control and Hospital Epidemiology Optional higher level processes have been included in these instructions Refer to ASTM F1518 00 Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in
11. rom the bulb and repeat rinse with sterile water 5 more times 10 The bulb must be dried sufficiently Any moisture inside the device could occlude the insufflation bulb filter if used or dilute disinfection or sterilization agents One way to achieve this is to hang the bulb with the tube down for a minimum of 24 hours Rigid Reusable amp Single use Sigmoidoscopes Anoscopes and Accessories ENGLISH 7 Sterilization 1 Follow steps 1 through 10 of the Cleaning instructions 2 Sterilize using a STERRAD 100S for one 55 minute cycle Validate any other sterilization equipment and load configurations Single Use Sigmoidoscopes and Anoscopes 53110 53130 Single Use Anoscope Single Use Sigmoidoscope Part Numbers Part Numbers 53110 53130 53110 B 53130 B 53110 JP 53130 F 53130 JP Caution Welch Allyn recommends the use of the Single Use Insufflation Bulb Filter 30210 for all applicable endoscopic procedures The filter does not eliminate the need to properly process the insufflation bulb with each use but restricts internal contamination and aspiration of fluids Q Caution Sterilization process is not valid for 53130 L and 53130 LF These single use devices are lubricated and cannot be sterilized Caution These devices are not reusable but can be sterilized one time prior to single use Sterilization 1 Remove the device from the plastic bag before sterilizing 2 Sterilize using a STERRAD 100S for one 55
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