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Zimmer Biomet

BIOMET 3i Slim Kit and Instruments Cleaning and Sterilization Guide

Revision Rev A

ZIMMER BIOMET Dental Systems

3 Pages

CLEANING AND STERILIZATION OF THE BIOMET 3i SLIM KIT AND INSTRUMENTS  Surgical instruments and instrument cases are susceptible to damage for a variety of reasons, including prolonged use, misuse, and rough or improper handling... are must be taken to avoid compromising their performance... o maintain the quality of surgical instruments, a standardized cleaning and sterilization protocol should be adopted... he recommended cleaning and sterilization procedures in this document apply to the BIOMET 3i Slim Kit and the instruments housed within... WARNINGS AND PRECAUTIONS DO NOT place used instruments back into the tray prior to proper cleaning per the following procedure (Steps 1-8)... nless otherwise indicated, instrument kits are NOT sterile and must be thoroughly cleaned and sterilized prior to use... nstruments should NOT be flash-autoclaved inside the instrument case... lash-autoclaving of individual instruments should be avoided... nwrapped instrument cases DO NOT maintain sterility... he following procedures DO NOT apply to powered instrumentation... or the High Torque Indicating Ratchet Wrench (H-TIRW), disassembly is required; please consult disassembly instructions accompanying the product... Recommended Procedures For Cleaning And Sterilization Of Surgical Instruments And Kit MATERIALS REQUIRED FOR PROCEDURES Solutions Neutral-pH detergent, or specialized cleaning solution Proteolytic enzyme detergent Ethyl alcohol (Ethanol); do not use rubbing alcohol (isopropyl alcohol) Tap water Distilled water Tools PPE: Personal Protective Equipment (gloves, goggles, apron, etc... Glass beakers Soft bristled brushes of various sizes Thin wire brush Autoclave-approved paper or bags Equipment Ultrasonic cleaning unit Steam autoclave  STEP-BY-STEP INSTRUCTIONS CLEANING OF INSTRUMENTS Note: Individuals who clean surgical instruments need to wear appropriate personal protective equipment... Following completion of a clinical surgical procedure, gather all instruments, prepare a solution for soaking using tap water (tepid or lukewarm) and a neutral-pH detergent at a dilution recommended by the detergent manufacturer... lace instruments in a single layer at the bottom of a glass beaker containing the dilute solution... oak the instruments for at least ten (10) minutes... ote: It is important to clean instruments as soon as possible; if immediate cleaning is not possible, continue to soak the instruments to prevent blood from drying on the surfaces...  2... Rinse with running tap water for a minimum of two (2) minutes while brushing exteriors of items individually with a soft bristled brush to remove visible debris; clean interior lumens of specified instruments with small brushes... 3... For internally irrigated instruments, ream each lumen with a thin wire to remove any remaining debris... ote: This step should be performed as soon as possible after use to remove any bone fragments or organic material that could clog the canal and prevent the flow of water... 4... Using a clean beaker, prepare a solution for ultrasonic cleaning using distilled water with a specialized enzymatic detergent per the detergent manufacturer’s recommendations... 5... Place all instruments in a single layer into the beaker of solution... lace the beaker containing the instruments into the ultrasonic bath and turn on for five (5) minutes... 6... Remove each instrument and repeat the scrubbing procedure; ream lumens of instruments having interior canals... ote: The performance of a drill’s internal irrigation system may be adversely affected after passing multiple sterilization cycles... 7... Rinse by flushing instruments for one (1) minute with a steady stream of running tap water... ote: This step is important to prevent spotting... 8... Inspect each instrument visually and check for cleanliness, any remaining bone fragments, visible soil or residual debris, and for visible damage and/or wear... epeat the scrubbing procedure as necessary... et aside the instruments specific to BIOMET 3i Slim Kit for packaging... CLEANING OF SURGICAL KIT 9... Detach the insert from the surgical tray... crub all surfaces of the surgical tray and the insert with mild soap using a soft bristled brush... 10... inse both pieces with running tap water for a minimum of two (2) minutes and inspect surfaces for cleanliness... 1... e-assemble the surgical kit by placing the insert back into the tray and replacing the cleansed instruments into specified grommets... ACKAGING KIT FOR STERILIZER 12... our ethyl alcohol over the surgical tray, the lid, and onto the instruments to rinse and remove residual soap and water minerals... llow the instruments to dry before wrapping... 3... lose the surgical kit and wrap it with autoclave paper twice, or place it within two (2) autoclave-approved bags... TEAM STERILIZATION PER ANSI/AAMI ST79 STANDARD * 14... RAVITY DISPLACEMENT STERILIZER (FULL CYCLE) The exposure time is a minimum of fifteen (15) minutes at a temperature of 270 – 275ºF (132-135ºC)...  Or – PRE-VACUUMED STERILIZER (HI-VAC) The exposure time is a minimum of four (4) minutes, four (4) pulses at a temperature of 270 – 275ºF (132-135ºC)... 5... ost-sterilization drying time is a minimum of thirty (30) minutes... TORAGE 16... nstruments should be dried completely and stored in a moisture-free environment... ailure to do so may result in stainless steel corrosion or staining... 7... rior to use, the exterior of each sterilized package should be inspected for integrity... f a package is suspect, it should not be used and should be reprocessed as per the above sterilization procedure... 8... helf life and sterility of wrapped instrument cases are dependent on storage in a manner to avoid extreme temperature, moisture, and/or other contamination... are must be exercised in the handling of wrapped cases to prevent damage to the sterile barrier... he probability of an occurrence of contamination increases over time, with handling, and based on the packaging method...  The recommended sterilization procedures have been validated by BIOMET 3i with its Slim Kit...
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Page 1

CLEANING AND STERILIZATION OF THE

BIOMET 3i

SLIM KIT AND INSTRUMENTS

Surgical instruments and instrument cases are susceptible to damage for a variety of reasons, including prolonged use, misuse,

and rough or improper handling. Care must be taken to avoid compromising their performance. To maintain the quality of

surgical instruments, a standardized cleaning and sterilization protocol should be adopted.

The recommended cleaning and sterilization procedures in this document apply to the BIOMET 3i Slim Kit and the instruments

housed within.

WARNINGS AND PRECAUTIONS

DO NOT place used instruments back into the tray prior to proper cleaning per the following procedure (Steps 1-8).

Unless otherwise indicated, instrument kits are NOT sterile and must be thoroughly cleaned and sterilized prior to use.

Instruments should NOT be flash-autoclaved inside the instrument case. Flash-autoclaving of individual instruments

should be avoided.

Unwrapped instrument cases DO NOT maintain sterility.

The following procedures DO NOT apply to powered instrumentation.

For the High Torque Indicating Ratchet Wrench (H-TIRW), disassembly is required; please consult disassembly

instructions accompanying the product.

Recommended Procedures For Cleaning And Sterilization Of Surgical Instruments And Kit

MATERIALS REQUIRED FOR PROCEDURES

Solutions

Neutral-pH detergent, or specialized cleaning solution

Proteolytic enzyme detergent

Ethyl alcohol (Ethanol); do not use rubbing alcohol (isopropyl alcohol)

Tap water

Distilled water

Tools

PPE: Personal Protective Equipment (gloves, goggles, apron, etc.)

Glass beakers

Soft bristled brushes of various sizes

Thin wire brush

Autoclave-approved paper or bags

Equipment

Ultrasonic cleaning unit

Steam autoclave

STEP-BY-STEP INSTRUCTIONS

CLEANING OF INSTRUMENTS

Note: Individuals who clean surgical instruments need to wear appropriate personal protective equipment.

1.

Following completion of a clinical surgical procedure, gather all instruments, prepare a solution for soaking using tap

water (tepid or lukewarm) and a neutral-pH detergent at a dilution recommended by the detergent manufacturer. Place

instruments in a single layer at the bottom of a glass beaker containing the dilute solution. Soak the instruments for at

least ten (10) minutes. Note: It is important to clean instruments as soon as possible; if immediate cleaning is not

possible, continue to soak the instruments to prevent blood from drying on the surfaces.

Page 2

2.

Rinse with running tap water for a minimum of two (2) minutes while brushing exteriors of items individually with a

soft bristled brush to remove visible debris; clean interior lumens of specified instruments with small brushes.

3.

For internally irrigated instruments, ream each lumen with a thin wire to remove any remaining debris. Note: This

step should be performed as soon as possible after use to remove any bone fragments or organic material that could

clog the canal and prevent the flow of water.

4.

Using a clean beaker, prepare a solution for ultrasonic cleaning using distilled water with a specialized enzymatic

detergent per the detergent manufacturer’s recommendations.

5.

Place all instruments in a single layer into the beaker of solution. Place the beaker containing the instruments into the

ultrasonic bath and turn on for five (5) minutes.

6.

Remove each instrument and repeat the scrubbing procedure; ream lumens of instruments having interior canals. Note:

The performance of a drill’s internal irrigation system may be adversely affected after passing multiple sterilization

cycles.

7.

Rinse by flushing instruments for one (1) minute with a steady stream of running tap water. Note: This step is

important to prevent spotting.

8.

Inspect each instrument visually and check for cleanliness, any remaining bone fragments, visible soil or residual

debris, and for visible damage and/or wear. Repeat the scrubbing procedure as necessary. Set aside the instruments

specific to BIOMET 3i Slim Kit for packaging.

CLEANING OF SURGICAL KIT

9.

Detach the insert from the surgical tray. Scrub all surfaces of the surgical tray and the insert with mild soap using a soft

bristled brush.

10. Rinse both pieces with running tap water for a minimum of two (2) minutes and inspect surfaces for cleanliness.

11. Re-assemble the surgical kit by placing the insert back into the tray and replacing the cleansed instruments into

specified grommets.

PACKAGING KIT FOR STERILIZER

12. Pour ethyl alcohol over the surgical tray, the lid, and onto the instruments to rinse and remove residual soap and water

minerals. Allow the instruments to dry before wrapping.

13. Close the surgical kit and wrap it with autoclave paper twice, or place it within two (2) autoclave-approved bags.

STEAM STERILIZATION PER ANSI/AAMI ST79 STANDARD *

14. GRAVITY DISPLACEMENT STERILIZER (FULL CYCLE)

The exposure time is a minimum of fifteen (15) minutes at a temperature of 270 – 275ºF (132-135ºC).

– Or –

PRE-VACUUMED STERILIZER (HI-VAC)

The exposure time is a minimum of four (4) minutes, four (4) pulses at a temperature of 270 – 275ºF (132-135ºC).

15. Post-sterilization drying time is a minimum of thirty (30) minutes.

STORAGE

16. Instruments should be dried completely and stored in a moisture-free environment. Failure to do so may result in

stainless steel corrosion or staining.

17. Prior to use, the exterior of each sterilized package should be inspected for integrity. If a package is suspect, it should

not be used and should be reprocessed as per the above sterilization procedure.

18. Shelf life and sterility of wrapped instrument cases are dependent on storage in a manner to avoid extreme temperature,

moisture, and/or other contamination. Care must be exercised in the handling of wrapped cases to prevent damage to

the sterile barrier. The probability of an occurrence of contamination increases over time, with handling, and based on

the packaging method.

* The recommended sterilization procedures have been validated by BIOMET 3i with its Slim Kit.

Page 3

BIOMET 3i cannot control individual clinic handling procedures, cleaning methods, bioburden levels, and other conditions, and

therefore assumes no responsibility for sterilization of product by the user, even when the recommended guidelines above are

followed.

This material is intended for clinicians and the BIOMET 3i Sales Force only. The distribution to any other recipient is

prohibited. This publication must not be used, copied or reproduced in whole or in part without the express written consent of

BIOMET 3i or its authorized representatives.

Providing Solutions – One Patient At A Time and design are trademarks of BIOMET 3i LLC.

©2013 BIOMET 3i LLC. All rights reserved.

BIOMET 3i, LLC

4555 Riverside Drive

: Batch Code

Palm Beach Gardens, FL 33410

1-800-342-5454

Outside The U.S.: +1-561-776-6700

Fax: +1-561-776-1272

www.biomet3i.com

:

Catalogue

number

: Do

BIOMET 3i Dental Iberica, S.L.

WTC Almeda Park, Ed. 1, Planta 1a

not use if

package is

damaged

: Consult

Instructions for

use

:

Caution: Law

prohibits

dispensing

without

prescription

Pl. de la Pau s/n

08940 – Cornellà de Llobregat

(Barcelona) Spain

Phone: +34 934 705 500

: Date of

Manufacture

Fax: +34 933 717 849

P-IISKI79 REV. A 10/13

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