Piezosurgery Touch / White Line and Reusable Inserts System Cleaning and Sterilisation Manual

CLEANING AND STERILIZATION MANUAL

Touch / White Line and Reusable Inserts

 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

SUMMARY

1 2

Introduction Clean/Flush Function

3 4

Disassembling of Parts Cleaning and Sterilization

2.1 2.2 2.3 2.4 4.1 4.1.1 4.1.2 4.1.3 4.2 4.2.1 4.2.2 4.2.2.1 4.2.2.2 4.2.2.3 4.2.2.4 4.2.2.5 4.2.2.6 4.2.2.7 4.2.2.8 4.2.3 4.2.3.1 4.2.3.2 4.2.3.3 4.2.3.4 4.2.3.5 4.2.3.6 4.2.3.7 4.2.3.8 4.2.4 4.2.4.1 4.2.4.2 4.2.5 4.2.6 4.2.7 4.2.7.1

II

Preparation PIEZOSURGERY® touch PIEZOSURGERY® white Perform the Cleaning Cycle

Cleaning of the Console and of the Foot Pedal Preparation Materials Required Cleaning Method Cleaning of Accessories Preparation Pre-Cleaning Materials Required Preparation Handpiece with Cord Inserts Inserts Torque Wrench Peristaltic Pump Tubes and Mobile Handpiece Support Tube-to-Tube Connector Irrigation Bag Support Rod and Fixed Handpiece Support Manual Cleaning Materials Required Preparation Handpiece with Cord Inserts Inserts Torque Wrench Peristaltic Pump Tubes and Mobile Handpiece Support Tube-to-Tube Connector Irrigation Bag Support Rod and Fixed Handpiece Support Automatic Cleaning Materials Required Automatic Cleaning Procedure Cleaning Check Drying and Lubrication Sterilization Sterilization Method

1 2 2 3 4 5

5 9

10 10 10 11 12 12 13 13 13 14 15 16 17 18 19 20 20 20 20 21 24 26 26 27 27 27 28 29 29 31 32



III

PAGE INTENTIONALLY LEFT BLANK

IV

Introduction

1

INTRODUCTION

Carefully read this manual before proceeding with the cleaning and sterilization operations, and always keep it within reach. IMPORTANT: to prevent harm to persons or damages to objects, read all the “Safety precautions”present in the manual with special care. Depending on their degree of seriousness, the safety precautions are classified with the following indications: WARNING: (always refers to personal injury) CAUTION: (refers to possible damage to property) The purpose of this manual is to make the operator knowledgeable of the safety precautions, the installation procedures, and the instructions for a correct use and maintenance of the device and its accessories. Use of this manual for purposes other than those strictly tied to cleaning and sterilization of the device is forbidden. The information and illustrations in this manual are updated as of the date of issue reported on the last page. Mectron is committed to continuously update its products with possible modifications to device components. In case you uncover discrepancies between what described in this manual and the device in your possession, contact your Retailer or the After-Sales Service of Mectron for clarification and support. LIMITATION ON THE NUMBER OF CLEANING AND STERILIZATION CYCLES: Cleaning and sterilization cycles repeated over time have minimum effects on the instruments examined in this Manual. The life expectancy of the products is usually determined by their consumption and by damages caused from their use. WARNING: The operators who perform the cleaning and sterilization operations must be adequately protected and trained.

WARNING: Infections control. First use: All new and repaired accessories are supplied in NON STERILE conditions. Before use, and after each treatment, they must be cleaned and sterilised in strict compliance with the instructions given in the Cleaning and Sterilization Manual. Subsequent uses: After every treatment, clean and sterilize all the reusable parts and accessories, following the instructions provided in the Cleaning and Sterilization Manual. WARNING: The cleaning processes must be commenced immediately after each use. Do not allow that contaminated instruments dry up before starting the cleaning and sterilization process. To eliminate organic remains such as blood, bone, and other, use an enzymatic detergent with neutral pH (pH7), immediately after use. CAUTION: Do not use metallic brushes or abrasive sponges during the cleaning processes, because they damage the surfaces of the treated parts and the finishes of the inserts. Only use brushes with soft nylon bristles. CAUTION: The detergent solution must be completely removed from the treated parts to prevent accumulation of chemical residues. CAUTION: During cleaning procedures only use detergents with pH 6-9. CAUTION: If you intend to disinfect, we recommend that you use water-based disinfectant solutions with a neutral pH (pH 7). Alcohol-based disinfectant solutions and hydrogen peroxide are contra-indicated, because they can fade the color and/or damage the plastic materials. This also holds true for chemical products such as acetone and alcohol. Always rinse with sterile water to preserve the disinfection. WARNING: Do not use tap water, unless where explicitly indicated.

1

WARNING: Reusable accessories that must be forwarded to an Authorized Mectron Service Center. All the parts must be cleaned and sterilized in accordance to the procedures described in this Manual, before they are sent to an Authorized Mectron Service Center. Incorrectly treated and bio-contaminated parts will not be accepted by the Authorized Mectron Service Centers.

2

CLEAN/FLUSH FUNCTION

The CLEAN/FLUSH function (according to the device used) enables to run a cleaning cycle on the irrigation circuit of the handpiece used during the treatment, by following the steps described in this chapter. CAUTION: Clean/flush function. The CLEAN/FLUSH function must be used after every treatment, before starting the cleaning and sterilization procedures.

2.1

CAUTION: The handpiece and the cord cannot be separated.

Preparation

Close the flow of the adjuster. Disconnect the flow adjuster from the irrigation bag and from the peristaltic pump tube or from the tube of the bone grafting kit, if used. Dispose of the flow adjuster correctly, following the norms in force locally on the disposal of hospital wastes;

Prepare an enzymatic detergent solution with pH 6-9, as per the instructions of the manufacturer;

2

CAUTION: If the tubes are not cleaned, the crystallization of the salts may seriously damage the device.

1

2

Clean/Flush Function Immerse the end part of the peristaltic pump tube or the tube of the bone grafting kit, if used, in a container containing the enzymatic detergent solution prepared;

Position the handpiece, with or without insert, above a container to contain the liquid that will outflow during the cleaning cycle;

2.2

3

4

PIEZOSURGERY® touch

To enter the cleaning mode, select PUMP/CLEAN on the keyboard: all the other selection options present on the display are disabled, and the PUMP/ CLEAN writing flashes;

1

NOTE: You can exit the cleaning mode by pressing on PUMP/CLEAN again or, alternatively, by waiting for at least 15 seconds. The Clean function is disabled and the keyboard is enabled again, and displays the last setting used;

3

To make the Clean function start while the PUMP/CLEAN writing is flashing, press the foot pedal once and release it: PUMP/CLEAN stops flashing and the cleaning cycle starts;

2

NOTE: The Clean function can be interrupted at any time by pressing the PUMP/CLEAN writing again or, alternatively, by pressing on foot pedal. The keyboard is enabled again, and displays the last setting used; As soon as the peristaltic pump starts, the entire scale of values of the “irrigation” section lights up and during the liquid passage, the value of the irrigation shifts from 6 a 0 . The cycle lasts 20 seconds. Once it has ended, the keyboard is enabled again, and displays the last setting used; Proceed with the procedure described in Chapter 2.4 on page 5.

2.3

3

PIEZOSURGERY® white

To enter the cleaning mode keep the PUMP/FLUSH button on the touch keyboard pressed; the LED of the level 6 of the function Irrigation flashes; all other buttons are disabled. To stop the FLUSH function release the button; Proceed with the procedure described in Chapter 2.4 on page 5.

1

1 0

Blu

R=66 G=124 B=254

4

Disassembling of Parts 2.4

Perform the Cleaning Cycle

To perform a cleaning cycle of every handpiece, tube, or connector used during the same treatment, repeat the operations described in Chapter 2.2 on page 3 or in Chapter 2.3 on page 4 depending on the device;

IMPORTANT: After the cleaning cycle with the enzymatic detergent solution, perform a new cleaning cycle with distilled water to remove detergent residues.

1

2

Once you have finished cleaning the irrigation circuit, move on to the cleaning and sterilization of each single part.

3

DISASSEMBLING OF PARTS

Before proceeding with the cleaning procedures described in Chapter 4 on page 9, disconnect all the accessories and components of the device. WARNING: Switch the device off. Always turn the device off via the switch, and disconnect the power supply cable from the power outlet and from the device console, before performing the cleaning and sterilization interventions.

1

off

WARNING: Supplementary grounding cable. If present, disconnect the supplementary grounding cable before you perform the cleaning and sterilization interventions.

5

Remove the handpiece fixed holder and the irrigation bag support rod from the device console;

Disconnect the foot pedal from the device: Grab the connector of the foot pedal, press the release flap, and pull the connector back;

2

3

CAUTION: Do not attempt to unscrew or turn the connector during the disconnection: the connector could get damaged. CAUTION: When disconnecting the foot pedal, always and only hold the connector of the cord. Never actually pull on the cord itself. Disconnect the handpiece from the device; CAUTION: To avoid damaging the handpiece, disconnect it by always holding onto the connector only. Never pull the cord.

6

4

Disassembling of Parts CAUTION: Do not attempt to unscrew or turn the connector when disconnecting the handpiece. The connector could get damaged.

CAUTION: The handpiece and cord cannot be separated.

Completely open the peristaltic pump and remove the peristaltic pump tube or the tube of the bone grafting kit (if present). Close the pump again;

Disconnect the peristaltic pump tube from the connector of the handpiece;

5

6

7

If the bone grafting kit has been used, disconnect the tube-to-tube connector from the peristaltic pump tube and from the tube of the bone grafting kit;

If present, unscrew the insert from the handpiece by using the torque wrench;

7

8

WARNING: During the tightening and removing operations, the user must pay particular attention to avoiding injury from inserts with sharp points and cutting edges.

Unscrew the front cone of the handpiece;

9

NOTE: USE OF THE HANDPIECE WITH LIGHT: on the cone with LED light the metal ring cannot be separated from the cone in plastic;

Remove the protective foil from the keyboard, if present.

8

10

Cleaning and Sterilization

4

CLEANING AND STERILIZATION

This table is purely indicative. For the complete cleaning and sterilization procedures of the individual parts, refer to the

Step I

Ref.

4.1

chapters indicated in the table. CAUTION: Methods not included in the table below must not be used.

Device surface and Pedal Manual cleaning with detergent

Procedure

Accessories (Handpiece, Inserts, Torque Wrench, Peristaltic Pump Tubes, Handpiece Mobile Support, Tube-to-Tube Connector, Irrigation Bag Support Rod and Handpiece Fixed Support) Step

Ref.

II

4.2.2

Procedure

Pre-Cleaning a)

Handpiece / Rod / Handpiece Fixed Support

Pump Tubes / Handpiece Mobile Support

Inserts

Manual cleanManual clean- ing with enzying matic detergent

4.2.4

Automatic cleaning

Thermal disinfector with detergent

IV

4.2.5

Cleaning Check

Visual inspection with 2,5x lens

V

4.2.6

Drying and luDrying brication

VI

4.2.7

Sterilisation

a)

Torque Wrench

Manual cleaning with enzyImmersion into enzymatic detergent matic detergent

4.2.3

III

Tubeto-Tube Connector

Immersion Immersion into enzymatic deinto enzytergent and ultrasonic washmatic detering gent

Drying and Lubrication

Packaging, Sterilisation and Storage

Optional.

9

4.1

Cleaning of the Console and of the Foot Pedal

4.1.1

Preparation

Make sure that all the following accessories have been removed/disconnected from the device console (see Chapter 3 on page 5): •

electrical power supply cable;

•

peristaltic pump tube;

• • • • • •

foot pedal;

handpiece;

handpiece fixed support;

irrigation bag support rod; protective foil (if present);

supplementary grounding connector (if present).

WARNING: Do not sterilize the device console and the foot pedal: it could stop working and cause harm to person and/or damages to things.

4.1.2 • •

Materials Required

Clean, soft cloths with low fiber-release; Detergent solution (pH 6-9).

CAUTION: If you wish to disinfect, we recommend that you use water-based disinfectant solutions with neutral pH (pH7). Alcohol-based disinfectant solutions and hydrogen peroxide are contra-indicated, because they can fade the color and/or damage the plastic materials. This also holds true for chemical products such as acetone and alcohol.

10

WARNING: Always turn the device off via the switch and disconnect it from the electrical network before performing the cleaning and disinfection interventions. WARNING: The device is not protected against penetration of liquids. Do not spray liquids directly onto the surface of the device. CAUTION: Do not clean the device console and the foot pedal under running tap water. CAUTION: Do not immerse the device console and the foot pedal in liquids and/or solutions of various nature.

Cleaning and Sterilization 4.1.3

Cleaning Method

Clean the surface of the device with a clean, soft cloth with low fiber-release, dampened with a detergent solution (pH 6-9);

1

pH 6

-9

Dry the device console and the foot pedal with a clean, non-abrasive cloth with low fiber-release.

2

11

4.2

Cleaning of Accessories

4.2.1

Preparation

1.

If present, disconnect the insert from the handpiece with the torque wrench;

NOTE: Choose between the following cleaning methods. In case the practice is not equipped with a thermodisinfector, the cleaning process can begin with the manual cleaning (Chapter 4.2.3 on page 20) and proceed with the sterilization (Chapter 4.2.7 on page 31). In case the practice is equipped with a thermodisinfector the cleaning process can be performed with automatic cleaning (Chapter 4.2.4 on page 27). The final step is always the sterilization (Chapter 4.2.7 on page 31).

Unscrew the front terminal of the handpiece;

Disconnect the irrigation bag support rod from the device console.

CAUTION: The cleaning and sterilizing operations described in the following paragraphs are to be performed upon initial use and prior to all successive uses.

Refer to Chapter 3 on page 5 for the disconnection of all accessories.

CAUTION: The following instructions have been validated by the medical device manufacturer as ABLE to reprocess a medical device for being reused. It is up to the process responsible to assure that the repeated processes are actually performed by means of equipment, materials and personnel structured as repeated processes in order to obtain the desired result. Generally this requires the validation and the systematic monitoring of the process. Similarly, in case the person in charge of the process deviates from the supplied instructions, he shall properly evaluate any action and their efficiency and the possible undesired consequences.

2. 3. 4.

5. 6. 7.

Perform the CLEAN/FLUSH function (see Chapter 2 on page 2); Disconnect the handpiece from the device console;

Disconnect the peristaltic pump tube from the connector of the handpiece;

Remove the tube from the peristaltic pump. If the bone grafting kit has been used, disconnect the tube-to-tube connector from both tubes;

CAUTION: The handpiece and the cord cannot be separated. CAUTION: Disconnect the handpiece from the device exclusively acting on the connector. CAUTION: Always disconnect the insert from the handpiece before proceeding to its cleaning and sterilization. CAUTION: Do not immerse the handpiece in disinfectant solutions or other liquids, because it could get damaged. CAUTION: Do not immerse the handpiece in an ultrasonic tank.

12

Cleaning and Sterilization 4.2.2

Pre-Cleaning

The "pre-cleaning" cycle is optional and preparatory to the chosen cleaning method (manual or automatic) and is recommended in the following cases: • •

if the accessories to be cleaned are particularly contaminated and/or dirty;

if a considerable time has passed since last use and pre-cleaning.

4.2.2.1 • • • • • • •

The person in charge of reprocessing activities will assess the need for a possible pre-cleaning cycle according to the conditions of the accessories, tools and specific requirements.

Materials Required

Enzymatic detergent (Mectron ENZYMEC, 0.8% v/v);

CAUTION: If you wish to disinfect, we recommend that you use water-based disinfectant solutions with a neutral pH (pH7). Alcohol-based disinfectant solutions and hydrogen peroxide are contra-indicated, because they can fade the color and/or damage the plastic materials. This also holds true for chemical products such as acetone and alcohol. Always rinse with sterile water to preserve the disinfection.

Water;

Container for immersion in the enzymatic liquid;

Clean, soft cloths with low fiber-release; Brush with soft nylon bristles; Syringe;

Demineralised water.

4.2.2.2

CAUTION: Do not use hydrogen peroxide. If you wish to disinfect the accessories, do not use hydrogen peroxide, but only disinfectants with neutral pH (pH7); always rinse with sterile water to preserve the disinfection.

Preparation

Prepare an enzymatic detergent solution b) with pH 6-9, as per the instructions of the manufacturer;

1

CAUTION: Once used, dispose of the enzymatic detergent correctly, do not recycle it. b) Process validated by independent body with enzymatic detergent Enzymec (Mectron).

13

4.2.2.3

Handpiece with Cord

Clean the surface of the scaler handpiece and of its connector with a clean, soft cloth with low fiber-release, dampened with a detergent solution (pH 6-9) c) ; c)

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

Delicately clean the surface of the handpiece using the enzymatic detergent solution with the aid of a brush with soft nylon bristles, placing special care to the following areas: •

threading of the handpiece;

•

front terminal in its external and internal parts.

•

3

titanium stem;

Completely rinse with tap water to eliminate any detergent residues and perform the last rinse with distilled water;

14

2

4