BD

10-5/8 in. (27 cm) Cobb Gouge, Bayonet

General Surgical Instrument Cleaning and Prevacuum Sterilization Guide

2 Pages

V.Mueller ® Products and Services General Surgical Instrument Cleaning and Prevacuum Sterilization Guide Reusable Devices Instructions for Use  Pre-processing Instructions  These instructions for use are intended for reusable surgical instruments labeled with the CareFusion, V. Mueller® name. This cleaning and sterilization guide does not replace device-specific instructions for use already included with the device.  Initiate cleaning of device within 2 hours of use. Transport devices via the institutions established transport procedure. Remove excess gross soil as soon as possible after use by rinsing or wiping the device. All devices must be processed in the completely open position (i.e. flushports, jaws, etc.) to allow solution contact of all surfaces. Note: that applicable device disassembly should not require any mechanical tooling (i.e. screwdriver, pliers etc.) unless otherwise indicated.  How Supplied Devices are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.  Limitations on Reprocessing Repeated processing has minimal effect on these devices. End of life is normally determined by wear and damage due to use.  Warnings Devices shall be used in accordance with these Instructions for Use. Read all sections of this IFU prior to use. Improper use of these devices may cause serious injury. In addition, improper care and maintenance of the devices may render the devices non-sterile prior to patient use and may cause serious injury to the health care provider or the patient.  Cautions If there are any variations between these Instructions for Use and either your facility’s policies and/or your cleaning/sterilizing equipment manufacturer’s instructions, those variations should be brought to the attention of the appropriate responsible hospital personnel for resolution before proceeding with cleaning and sterilizing your devices. Use of a device for a task other than what it is intended for will usually result in a damaged or broken device. Prior to use, inspect devices to ensure proper function and condition. Do not use devices if they do not satisfactorily perform their intended function or if they have physical damage. Avoid mechanical shock or overstressing the devices. Close distal ends prior to insertion or removal through cannulas. Always use caution when inserting or removing devices through the cannula. Lateral pressure on the device during removal can damage the working tip, and/or shaft of the device. Be sure the tips are closed and the device is pulled straight out until completely clear of the cannula to avoid catching the valve assemblies in cannulas or dislodging the cannula. Fading of anodized aluminum devices may be accelerated if cleaning and sterilization instructions are not followed. Only the cleaning and sterilization processes which are defined within these Instructions for Use have been validated. Use only neutral pH (6-8) detergent solutions.  USA Rx Only © 2017 CareFusion Corporation or one of its affiliates. All rights reserved.  CareFusion 75 North Fairway Drive Vernon Hills, IL 60061 USA 36-6298 • 2017-04  © 2017 CareFusion Corporation or one of its affiliates. All rights reserved.  CareFusion 75 North Fairway Drive Vernon Hills, IL 60061 USA 36-6298 • 2017-04  36-6298 06-01-17 David Knuth Vernon Hills, IL  Proofed by: Dimensions checked:  Manual Cleaning Manual Cleaning Process - Enzymatic/neutral pH Detergent Note: Steps 5, 6, 7, 9, and 11 pertain to only devices with lumens. 1. Ensure all pre-processing instructions are followed prior to cleaning. 2. Prepare the enzymatic/neutral pH detergent solution, utilizing drinking water with a temperature range of 27°C to 44°C (81°F to 111°F), per manufacturer’s instructions. 3. Place the device in the open/relaxed position with flush port open. Completely immerse the device in the detergent solution and allow it to soak for a minimum of 5 minutes. Actuate all movable parts during the initiation of the soak time. 4. Using a soft bristled brush, remove all visible soil from the device. Actuate the device while brushing, paying particular attention to hinges, crevices and other difficult to clean areas. Note: It is recommended that the detergent solution be changed when it becomes grossly contaminated (bloody and/or turbid). 5. For lumen devices, use a soft bristled brush with a brush diameter and length that is equivalent to lumen diameter and length. Scrub the lumen (i.e. angulated/nonangulated positions) until no visible soil is detected in the lumen rinsing step below. 6. For lumen devices, place the device into the open/relaxed position with the distal tip pointed down. Flush the device with a minimum of 50 ml of detergent solution utilizing a temperature range of 27°C to 44°C (81°F to 111°F), by using the flushing port located on the handle/shaft. Repeat the flush process a minimum of 2 times (i.e. total of 3 times), ensuring all fluid exiting the lumen is clear of soil. 7. For lumen devices, if visible soil is detected during the final lumen flush, re-perform brushing and flushing of the lumen. Note: the final rinse steps (8 and 9) below should be performed with treated water: deionized, distilled or reverse osmosis. If drinking water is used as part of the final rinse, ensure corrosion does not occur. 8. Rinse the device by completely immersing it in treated water with a temperature range of 27°C to 44°C (81°F to 111°F), for a minimum of 30 seconds to remove any residual detergent or debris. 9. For lumen devices, following the rinsing step, place the device into the open/relaxed position with the distal tip pointed down. Flush the device with a minimum of 50 ml of treated water utilizing a temperature range of 27°C to 44°C (81°F to 111°F), by using the flushing port located on the handle/shaft. Repeat the flush process a minimum of 2 times (i.e. total of 3 times). 10. Dry the device with a clean, lint-free towel. 11. For lumen devices, manipulate the device to allow rinse water to drain from the lumen. 12. Visually examine each device for cleanliness. 13. If visible soil remains, repeat cleaning procedure until the device is thoroughly clean.  Date: Copy checked:
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File Name: BD - V.Mueller - 36-6298 - General Surgical Instrument Cleaning and Prevacuum Sterilization Guide - 2017-04.pdf

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