Rigid reusable and Single Use sigimodoscopes, anoscopes and acc Cleaning, disinfection and sterilization Instructions Ver A April 2021

Welch Allyn® rigid reusable and single-use sigmoidoscopes, anoscopes, and accessories Cleaning, disinfection, and sterilization instructions 773583, DIR 80028025 Ver. A, Revision date: 2021-04

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.

Rigid sigmoidoscopes, anoscopes, and light carrier

Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA hillrom.com

Welch Allyn, Inc. is a subsidiary of Hill-Rom Holdings, Inc. Authorized Australian Sponsor Welch Allyn Australia Pty. Ltd. Unit 4.01, 2-4 Lyonpark Road Macquarie Park, NSW 2113 Phone 1800 650 083 PATENTS / PATENT hillrom.com/patents May be covered by one or more patents. See above Internet address. The Hill-Rom companies are the proprietors of European, US, and other patents and pending patent applications. © 2021 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 Johnson Company.

ENGLISH

37023

32820

36019

Anoscope

Sigmoidoscope

Light carrier

part numbers

part numbers

part numbers

37019

38614

32010

32820

36019

37023

38619

32020

32830

38700

37027

38622

32410

33220

38108

38900

32420

33620

Suction tube* part numbers

38114

39614

32810

33830

38119

39619

38122

39622

30130 30140

*Suction tubes not illustrated NOTE For all steps, remove obturator for separate cleaning and open viewing window. 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.

Intended use

Cleaning

The Welch Allyn rigid reusable & 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.

1. 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.

Endoscopes and the insufflation system are categorized as semicritical 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. Refer to ASTM F1518-00, “Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in 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.

High Level Disinfection 1. Follow the Cleaning instructions above. 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 item for a minimum of 5 minutes each with sterile water. 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

Insufflation system

Single-use sigmoidoscopes and anoscopes Do not disassemble this connection

Part Numbers 73210 and 73211

Part Number 73500

(including 07800-U lamp)

(including 03100-U lamp)

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

Rectal Light Handle Outer Sleeve

CCW

CW

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. After performing a reprocessing procedure, wipe the lamp with a soft, dry, lint free cloth. 5. Re-attach the clean sleeve to the handle by screwing in a clockwise direction. 6. 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. 2. Submerge the rectal light handle outer sleeve 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. Wet the rectal light handle body and cord with the cleaning solution. 5. 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) 1. Follow the Cleaning instructions above. 2. Using CaviWipes™, wipe all item surfaces and keep wet with CaviWipe solution for a minimum of 5 minutes. 3. Allow the item surface to dry for a minimum of 10 minutes.

Sterilization (73211 ONLY) CAUTION Autoclaving the light handle may reduce the product’s functional life. 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.

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.

Cleaning

1. 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. 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.

High level 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 a clean 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 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.

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.

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. 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 minute cycle. Validate any other sterilization equipment.

Power supply 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.