Piezosurgery flex Cleaning and Sterilisation Manual Rev 02 Sept 2021

 Copyright © Mectron S.p.A. 2021. All rights reserved. No part of this document can be reproduced in any form without the written consent of the copyright owner.

I

flex 1 2 3

3.1 3.1.1 3.1.2 3.1.3 3.2 3.2.1 3.2.1.1 3.2.1.2 3.2.1.3 3.2.1.4 3.2.1.5 3.2.2 3.2.2.1 3.2.2.2 3.2.2.3 3.2.2.4 3.3 3.4 3.5 3.5.1 3.5.2 3.5.3

II

TABLE OF CONTENTS

Introduction Disassembly of Parts Cleaning and Sterilisation

Cleaning of the Device Console and the Foot Pedal Preparation Materials Required Cleaning and Disinfection Method Cleaning and Sterilization of the Accessories Manual Cleaning Preparation Materials Required Immersion in Enzymatic Detergent Immersion in Mild Detergent Ultrasonic Bath Combined Manual/Automatic Cleaning Preparation Materials Required Immersion in Enzymatic Detergent Thermodisinfection Cleaning Check Drying and Lubrication of the Accessories Sterilisation Preparation Materials Required Sterilisation Method

1 2 5

6 6 6 6 7 7 7 8 8 11 13 14 14 14 15 18 20 20 21 21 22 22



III

flex

PAGE INTENTIONALLY LEFT BLANK

IV

Introduction

1

INTRODUCTION

Carefully read this manual before proceeding with the installation, use, maintenance operations or other interventions on the device. Keep it always within reach in the re-processing areas of the device and of its accessories.

to ensure that the reprocessing as actually performed, using equipment, materials and personnel in the reprocessing facility, achieves the desired result. This normally requires validation and routine monitoring of the process.

IMPORTANT: to avoid potential serious injury to the user and the patient and/ or this device or other equipments, read all the “Safety precautions” present in the manual with particular attention. The words WARNING, CAUTION and NOTE contained in this document, carry special meaning and must be carefully reviewed. Depending on their degree of seriousness, the safety precautions are classified:

NOTE: The following PIEZOSURGERY® flex accessories are supplied non-sterile and must be cleaned and sterilised at first use and at each re-use:

WARNING: (Identifies conditions or practices that present a risk of serious injury or death to the patient and/or the user) CAUTION: (Identifies conditions or practices that could result in minor injury or device damage) NOTE: Identifies special information to clarify or emphasize important instructions. The main purpose of this manual is to protect patients, surgeons and healthcare personnel from possible infections caused by contamined instruments. It is therefore essential to perform every single step of the re-processing procedure with the utmost care. These instructions supply detailed information in order to assist healthcare personnel in safe handling practices and effective cleaning procedure for: • •

PIEZOSURGERY® flex device; Foot pedal;

and an effective cleaning and sterilisation procedure for: • •

Handpiece;

Torque wrench.

The instructions provided in this manual have been validated by the manufacturer as being CAPABLE of preparing the product for re-use. It remains the responsibility of the processor

• •

handpieces,

torque wrenches.

WARNING: The procedures described in this manual do not apply to single use accessories, which are delivered in sterile condition. These accessories cannot be reused. Do not attempt to re-use or re-sterilized any single-use item. Single-use items must be discarded following each surgical procedure according to hospital protocol for disposal of biocontaminated wastes. The cleaning and maintenance manual must be used together with the “Manual of Use and Maintenance” supplied with the unit PIEZOSURGERY® flex. LIMITATIONS TO REPEATED PROCESSES: Repetition of processes has a minimal effect on these instruments. The end of the life is generally a result of the wear, tear and damages suffered through use. Wear and tear of instruments must be determined through visual examination. WARNING: Cleaning and sterilisation of reusable instruments, brand new or returned by service. All reusable accessories (brand new or returned by service) are not sterile. AT FIRST USE and after each treatment they must be cleaned and sterilized applying the procedures thoroughly described in this manual. WARNING: Infection control. Special care must be taken in handling contaminated inserts as they are a cause of a potential danger of infection. Hospital personnel must wear suitable personal protection equipment.

1

flex WARNING: Handle sharp-edge and pointed instruments with care.

2

DISASSEMBLY OF PARTS

Before proceeding with the cleaning procedures described in Chapter 3 on page 5, disconnect all the accessories and components of the PIEZOSURGERY® flex. If there is any doubt in carrying out the disassembling procedures described below, make reference to the ‘Manual of Use and Maintenance’. WARNING: Turn the console off by means of the MAIN SWITCH on the device body and disconnect it from the electrical power source. Unplug all cords from the device console (handpiece cord and foot pedal cord).

1

on off

WARNING: Supplementary equipotential cable. If present, disconnect the supplementary equipotential cable before the cleaning and sterilisation procedures. Unplug the foot pedal from the console: grab the connector of the foot pedal, press the release sleeve and pull the connector back to remove;

2

CAUTION: Do not attempt to unscrew or rotate the connector when disconnecting: the connector may become damaged. CAUTION: Hold always and only the connector when disconnecting the foot pedal. Never pull on the cord itself. Disconnect the handpiece from the console; CAUTION: Perform this operation only by holding the connector. Never pull on the cord itself.

2

3

Disassembly of Parts CAUTION: Do not attempt to unscrew or twist the connector when disconnecting the handpiece. The connector could get damaged. CAUTION: The handpiece and its cord cannot be separated.

Remove the irrigation kit as follows: •

4

Remove the spike from the irrigation bag;

NOTE: Close the irrigation kit clamps before disconnecting it from the irrigation bag.

• •

•

Open the peristaltic pump cover completely and remove the tube;

5

Close the peristaltic pump cover;

Remove the tube and the clips from the handpiece cord;

6

3

flex • •

Disconnect the tube from the nozzle placed on the back of the handpiece;

7

Dispose of the irrigation kit in accordance with the current regulations governing hospital waste;

Remove the insert from the handpiece using the torque wrench supplied with the device; Dispose of the insert in accordance with current regulations governing hospital waste;

8

CAUTION: Only use the PIEZOSURGERY® medical torque wrench to tighten and remove the insert on/ from the handpiece. Do not use any other tools, such as pliers, scissors, etc. Unscrew the front metal cone from the handpiece, rotating it counter-clockwise;

Connect the protection cap to the ending section of the cable, in correspondence of the cord fairlead; Insert the cap onto the handpiece cord connector. CAUTION: Always install the protection cap before cleaning. CAUTION: Before starting the cleaning process, always visually inspect the protection cap for any damage. Replace it if any anomalies are detected.

4

9

10

Cleaning and Sterilisation

3

CLEANING AND STERILISATION

Table 1 and Table 2 are indicative, only. For the complete cleaning and sterilization procedures of the individual parts, refer to the chapters indicated in the tables. CAUTION: Methods not reported in the tables below must not be used.

WARNING: Sterile single-use. Sterile single-use objects must only be used in one surgical procedure and on one patient. Single-use objects must not be reused. Separate and dispose of each single-use object in accordance with current regulations governing hospital waste. WARNING: Before using any Piezosurgery® Medical insert inspect the sterile package and the product for any damage. Insert loses sterility in case of broken or damaged packaging.

Phase Chapter I

3.1

Device Console and Foot Pedal Procedure

Manual cleaning with detergent

Table 1 – Cleaning of the Device Console and the Foot Pedal Phase Chapter

Accessories (Handpiece and Torque Wrench) Procedure

Handpiece

Torque Wrench

Immersion into detergent

Ultrasonic washing

Immersion into enzymatic detergent

3.2.1

Manual cleaning

3.2.2

Combined manual/automatic cleaning

III

3.3

Cleaning check

IV

3.4

Drying and lubrication

Drying

V

3.5

Sterilisation

Packaging, Sterilization and Storage

II

Immersion into enzymatic detergent Washer - disinfector with detergent Visual inspection Drying and Lubrication

Table 2 – Cleaning and Sterilization of the Accessories (Handpiece and Torque Wrench)

5

flex

3.1

Cleaning of the Device Console and the Foot Pedal

3.1.1

Preparation

Make sure that all the following accessories have been removed/disconnected from the device console (see Chapter 2 on page 2):

WARNING: The device console is not protected against the penetration of liquids. Do not spray liquids directly onto the surface of the console.

•

electric power supply lead;

•

handpiece;

CAUTION: Do not immerse the device console or foot pedal in liquids and/or solutions of other types.

supplementary equipotential cable connector (if present);

CAUTION: Do not sterilise the device console or the foot pedal.

WARNING: Always turn off the console using the ON/OFF switch and disconnect it from the electrical power source before performing the cleaning and disinfection interventions.

CAUTION: Do not rinse the electric contacts of the foot pedal under running water.

• • • •

irrigation kit;

irrigation bag support rod;

foot pedal.

3.1.2 • •

CAUTION: Do not use machinery/devices to clean the device console or foot pedal.

Materials Required

Clean, soft lint-free cloths;

CAUTION: For disinfection, if required, it is recommended to use water-based disinfectant solutions, with neutral pH (pH7). Alcohol-based disinfectant solutions and hydrogen peroxide are contraindicated as they can discolour and/or damage plastic materials. This also applies to chemicals such as acetone and alcohol.

Detergent (pH 6-9) and, if necessary, a non-aggressive neutral pH (pH 7) disinfectant solution.

3.1.3

Cleaning and Disinfection Method

Clean the surface of the console and of the foot pedal with a clean, soft lintfree cloth, dampened with a detergent solution (pH 6-9) and, if necessary, disinfect with a non-aggressive neutral pH (pH 7) disinfectant solution, following the instructions provided by the manufacturer of the solution;

1

pH 6

-9

6

Cleaning and Sterilisation Dry the device console using a clean, non-abrasive, soft lint-free cloth;

Dry the foot pedal using a clean, non-abrasive, soft lint-free cloth.

3.2

•

Manual cleaning;

Combined manual/automated cleaning.

The procedures applicable to the Piezosurgery® Medical accessories have been validated by an indipendent body.

3.2.1

Manual Cleaning

3.2.1.1

Preparation

The process accessories:

applies

•

Handpiece;

•

Torque wrench.

•

3

Cleaning and Sterilization of the Accessories

The Operator can choose between the following cleaning procedures: •

2

to

the

following

Front metal cone;

After having disconnected the accessories, following the instructions provided in Chapter 2 on page 2 proceed with the cleaning procedure described in the following.

WARNING: The automated cleaning must not be used as the sole cleaning method for surgical instruments. The automated cleaning cycle must always be preceded by a manual cleaning procedure.

CAUTION: Always remove the insert from the handpiece before proceeding to its cleaning. CAUTION: Always install the protection cap before cleaning. CAUTION: Before proceeding with the cleaning, always visually inspect the protection cap for any damage. Replace it if any anomalies are detected. CAUTION: Do not immerse the handpiece in ultrasonic tank.

7

flex 3.2.1.2

Materials Required

•

Enzymatic detergent with pH 6-9;

•

Suitably-sized container;

• • • • • •

CAUTION: For disinfection, if required, it is recommended to use water-based disinfectant solutions, with neutral pH (pH7). Alcohol-based disinfectant solutions and hydrogen peroxide are contraindicated as they can discolour and/or damage plastic materials. This also applies to chemicals such as acetone and alcohol. Always rinse with sterile water to preserve the disinfection.

Tap water;

Clean soft bristled, nylon brush; Ultrasonic tank; Distilled water; Syringe;

Water jet pistol.

CAUTION: Cleaning instruments. Use appropriated cleaning instruments, as specified in this Manual. Never use metal brushes, scouring pads, abrasive instrumens or pointed objects for the residues removal during the manual cleaning procedures. These materials may damage in a permanent and defintive way the surface and finish of instruments. Use exclusively soft-bristled, nylon brushes and pipe cleaners.

WARNING: Start the reprocessing procedures at the end of each intervention. Do not allow contaminated tools to dry prior to reprocessing. CAUTION: During cleaning, do not use detergents with a pH outside the range of 6-9. Do not use organic solvents such as acetone or isopropyl alcohol to clean the instruments. Saline cleaning agents containing aldehydes, mercury, active chlorine, chloride, bromine or bromide, iodine or iodide or fixing or corrosive proteins must never be used. Do not place or soak instruments in a rinsing solution. Do not use solvents, lubricants or other products with chemical characteristics that differ from those specified. Use of these products can cause the instruments to malfunction or the release of undesired substances at the operating site. 3.2.1.3

CAUTION: Use either tap water or demineralised water, as indicated by this manual. CAUTION: Dispose of the enzymatic detergent correctly once used. Do not recycle.

Immersion in Enzymatic Detergent

This procedure applies to the following accessories: • •

Handpiece;

Prepare a mild pH (6-9) enzymatic detergent solution a) according to the manufacturer’s instructions; a)

8

•

Front metal cone;

Process validated by independent , accredited testing laboratory with enzymatic detergent Cidezyme® (Enzol®).

1

Torque wrench.

Cleaning and Sterilisation Place the handpiece, front metal cone and torque wrench in a container. Add sufficient enzymatic detergent solution to completely cover the accessories;

2

CAUTION: Do not immerse the handpiece if warm.

Leave the handpiece, front metal cone and torque wrench soaking for 10 minutes at 40 °C ±2; This will reduce the organic residues on the instruments;

Under running tap water use a clean soft-bristled nylon brush to deeply clean, without damaging it, the surfaces of the handpiece, of the front metal cone and of the torque wrench. Perform this operation until all visible soils have been removed. Rinse the handpiece cord as well;

3 10 min

40°C

4

9

flex WARNING: The following parts must be brushed carefully: Handpiece • • •

Threaded part onto which the inserts are screwed;

Threaded part onto which the front metal cone is screwed; Parts adjacent to the threads;

Front metal cone •

The internal threaded part;

Torque wrench • •

External metallic ring;

Internal channels and cavities.

NOTE: Rinse the cavities, the grooves, the crevices and the critical parts thoroughly. CAUTION: To prevent the accumulation of enzymatic detergent residues, rinse the instrument surfaces thoroughly. HANDPIECE: By using a disposable syringe (min. 50 ml) inject for 3 times the enzymatic detergent solution inside the internal cavities and channels of the handpiece for effective removal of soil from the inner lumen surface;

10

5

Cleaning and Sterilisation Rinse the internal channels by injecting cold distilled/demineralized water with a pressure of 3,8 bar for 10 seconds to eliminate any enzymatic detergent residue;

6

NOTE: Always perform the rinsing procedure of the handpiece internal channel. Inject the liquid from the back part, taking care of using a water bath to avoid splashing. A free drain of water through the internal channel is required. All the above procedures must be repeated until rinse water runs without residues. 3.2.1.4

Immersion in Mild Detergent

This procedure applies to the following accessories: •

Handpiece;

Prepare a neutral pH cleaner solution b) according to the manufacturer’s instructions;

•

Front metal cone.

7

b) Process validated by independent body with enzymatic detergent Enzymec (Mectron).

Place the handpiece and the front metal cone in a container. Add sufficient neutral pH cleaning solution into the container to completely cover the handpiece and front metal cone;

8

11

flex Under running tap water use a softbristled nylon brush to deeply clean, without damaging it, the handpiece and the cone surfaces. Perform this operation to remove all visible contamination soils. Rinse the handpiece cord as well;

9

WARNING: The following parts must be brushed carefully: Handpiece • • •

Threaded part onto which the inserts are screwed;

Threaded part onto which the metallic front cone is screwed; Parts adjacent to the threads

Front metal cone •

The internal threaded part.

Rinse the internal channels, injecting cold distilled/demineralised water at a pressure of 3.8 bars, to eliminate all detergent residues. NOTE: Always perform the rinsing procedure of the handpiece internal channel. Inject the liquid from the back part, taking care of using a water bath to avoid splashing. A free drain of water through the internal channel is required. All the above procedures must be repeated until rinse water runs without residues.

12

10

Cleaning and Sterilisation 3.2.1.5

Ultrasonic Bath

This procedure applies to the following accessories: •

Torque wrench.

Prepare an enzymatic detergent solution with pH 6-9 c) according to the manufacturer’s instructions and pour it into an ultrasonic tank; c)

11

Process validated by independent, accredited testing laboratory with enzymatic detergent Cidezyme® (Enzol®)

Place the torque wrench into a suitable tray (stainless steel washing machine tray with partitions). Place the tray in the ultrasonic tank for 10 minutes at 40 °C;

Remove the torque wrench from the ultrasonic cleaner and rinse it with cold demineralised water;

12 10 min

40°C

13

NOTE: Rinse the cavities, grooves and crevices and all difficult-to-reach areas thoroughly.

Brush the torque wrench surface gently with a clean soft bristled, nylon brush.

14

13

flex 3.2.2

Combined Manual/Automatic Cleaning

3.2.2.1

Preparation

The automated cleaning must not be used as the sole cleaning method for surgical instruments. The automated cleaning cycle The process accessories:

applies

•

Handpiece;

•

Torque wrench.

•

to

the

following

Front metal cone;

After having disconnected the accessories, following the instructions provided in Chapter 2 on page 2 proceed with the cleaning procedure described in the following.

must always be preceeded by a manual cleaning procedure as described below.

CAUTION: Always remove the insert from the handpiece before proceeding to its cleaning. CAUTION: Always install the protection cap before cleaning. CAUTION: Before proceeding with the cleaning, always visually inspect the protection cap for any damage. Replace it if any anomalies are detected. CAUTION: Do not immerse the handpiece in ultrasonic tank.

3.2.2.2

Materials Required

•

Enzymatic detergent with pH 6-9;

•

Suitably-sized container;

• • • • • • •

Tap water;

Clean soft bristled, nylon brush; Distilled water; Syringe;

Washer - Disinfector; Alkaline detergent;

Neutralising solution.

WARNING: Start the reprocessing procedures at the end of each intervention. Do not allow contaminated tools to dry prior to reprocessing.

CAUTION: During cleaning, do not use detergents with a pH outside the range of 6-9. Do not use organic solvents such as acetone or isopropyl alcohol to clean the instruments. Saline cleaning agents containing aldehydes, mercury, active chlorine, chloride, bromine or bromide, iodine or iodide or fixing or corrosive proteins must never be used. Do not place or soak instruments in a rinsing solution. Do not use solvents, lubricants or other products with chemical characteristics that differ from those specified. Use of these products can cause the instruments to malfunction or the release of undesired substances at the operating site. CAUTION: For disinfection, if required, it is recommended to use water-based disinfectant solutions, with neutral pH (pH7). Alcohol-based disinfectant solutions and hydrogen peroxide are contraindicated as they can discolour and/or damage plastic materials. This also applies to chemicals such as acetone and alcohol. Always rinse with sterile water to preserve the disinfection.

14

Cleaning and Sterilisation CAUTION: Cleaning instruments. Use appropriated cleaning instruments, as specified in this Manual. Never use metal brushes, scouring pads, abrasive instrumens or pointed objects for the residues removal during the manual cleaning procedures. These materials may damage in a permanent and defintive way the surface and finish of instruments. Use exclusively soft-bristled, nylon brushes and pipe cleaners. 3.2.2.3

CAUTION: Use either tap water or demineralised water, as indicated by this manual. CAUTION: Dispose of the enzymatic detergent correctly once used. Do not recycle.

Immersion in Enzymatic Detergent

This procedure applies to the following accessories: • •

Handpiece;

•

Front metal cone;

Prepare a mild pH (6-9) enzymatic detergent solution d) according to the manufacturer’s instructions;

Torque wrench.

1

d) Enzymatic detergent Enzymec (Mectron), process validated by independent, accredited testing laboratory.

Place the handpiece, metallic front cone and torque wrench in a container. Add sufficient enzymatic detergent solution to completely cover the accessories;

2

CAUTION: Do not immerse the handpiece if warm.

15