MECTRON

Piezosurgery System Cleaning and Sterilisation Manual

26 Pages

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File Size: 4.63 MB

File Name: MECTRON - Piezosurgery System Cleaning and Sterilisation Manual.pdf

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Page 1

Cleaning and Sterilisation Manual

Û CONTENTS EN

INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

DISMANTLING OF PARTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

03 REFERENCE TABLE FOR CLEANING AND STERILISATION PROCEDURES. . . . . . . . . . . . . . . . . . . .

CLEANING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 04.1 Cleaning the device console and foot pedal. . . . . . . . . . . . . . . . 8 04.2 Cleaning accessories: manual . . . . . . . . . . . . . . . . . . . . . . . . . 10 04.3 Cleaning accessories: combined manual/automatic. . . . . . . . . 16 04.4 Cleaning accessories: automatic . . . . . . . . . . . . . . . . . . . . . . . 21

CHECKING CLEANING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

DRYING AND LUBRICATION OF ACCESSORIES . . . . . . . .

STERILISATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

introduction

INTRODUCTION

Please read this manual carefully before proceeding to install, use, maintain or carry out any other interventions on the device. Make sure it is available at all times in the reprocessing rooms of the device and its accessories. IMPORTANT: to avoid any injury to people or damage to property, please pay careful attention to all the “Safety requirements” included in this manual. Depending on the level of risk involved, the safety requirements are classified as follows: DANGER (always related to personal injury) WARNING (relating to possible damage to objects) A NOTE identifies special information that may allow for simpler system maintenance or clarify or emphasise important instructions. The main aim of this manual is to protect patients, surgeons and hospital personnel from possible infections caused by contaminated instruments. It is therefore essential to pay careful attention when performing each step of the reprocessing procedure. These instructions provide detailed information to allow hospital personnel to safely manage all operations and carry out effective cleaning of the: - Piezosurgery® device; - Foot pedal; and effective cleaning and sterilisation of: - Handpiece; - Torque wrench. The hospital or site that physically carries out the procedures is responsible for cleaning and sterilising the instruments. The procedures and parameters described in this manual have been validated by laboratory tests carried out by an independent entity. These tests have confirmed that the sterility level (SAL) of 10-6 is only achieved if the instructions described in this manual are followed perfectly. All the stages of sterilisation must be carried out by the operator in accordance with UNI EN ISO 17665-1:2007 and UNI EN ISO 556-1:2002 standards.

WARNING: The instructions given below are intended for qualified personnel able to treat medical devices for their re-use. These instructions have been validated by Mectron S.p.a. The site remains responsible for ensuring that reprocessing is carried out in such a way as to achieve the desired results, by using the instructions, the equipment and the materials described here, and qualified personnel. The process must be regularly monitored and validated. Any deviation applied by the reprocessing site with respect to that specified in these instructions must be validated and the effectiveness and potential adverse consequences assessed.

NOTE: The following PIEZOSURGERY® medical accessories are supplied non-sterile and must be cleaned and sterilised at first use and at each re-use: Handpieces; Torque wrenches. DANGER: The procedures described in this manual do not apply to sterile, singleuse accessories. These accessories cannot be reused. Single-use parts are supplied in sterile packaging and are not intended to be re-used. The cleaning and sterilisation manual must be used together with the “Use and maintenance manual” supplied with the Piezosurgery® unit. 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 and tear and damages suffered through use. Wear and tear of instruments must be determined through visual examination.

DANGER: Cleaning and sterilisation of new or repaired tools. All new and repaired device accessories are supplied in non-sterile conditions. At FIRST USE, and after each treatment, they must be cleaned and sterilised in strict compliance with the instructions given in this manual.

DANGER: 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. DANGER: Handle sharp and pointed instruments carefully.

DISMANTLING OF PARTS

Before moving onto the cleaning procedure described in Chapter 04 - CLEANING, disconnect all device accessories and components. DANGER: Disconnect the device from the power supply using the GENERAL SWITCH on the device console and disconnect it from the electricity supply. Disconnect all leads from the device (handpiece cord and foot pedal).

DANGER: Supplementary equipotential cable. If present, disconnect the supplementary equipotential cable before cleaning or sterilising.

Disconnect the device foot pedal: press the foot pedal connector release sleeve and pull the connector backwards; WARNING: Do not attempt to unscrew or rotate the connector when disconnecting: the connector may become damaged. WARNING: When disconnecting the foot pedal cable, always hold the cord connector only. Never pull the cord.

on off

02 3

dismantling of parts Disconnect the handpiece from the device; WARNING: Grip the connector only when carrying out this operation. Do not carry out this manoeuvre using the cord. Do not attempt to unscrew the connector when disconnecting the handpiece. The connector may become damaged.

WARNING: The handpiece and its cord cannot be separated. 4

Remove the irrigation kit as follows: Remove the spike from the irrigation bag; NOTE - Close the irrigation kit clamps before disconnecting it from the irrigation bag.

Open the peristaltic pump fully and remove the tube; Re-close the peristaltic pump;

Remove the tube and clips from the handpiece cord;

Disconnect the tube from the nozzle on the back of the handpiece; Dispose of the irrigation kit in accordance with 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;

WARNING: 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 insert cover or metallic front cone of the handpiece by twisting in an anticlockwise direction; Dispose of the insert cover in accordance with current national regulations governing hospital waste;

WARNING: The metallic cone should not be disposed of; rather it should be reprocessed with the other Piezosurgery® medical instruments.

FOR INSERTS WITH EXTENSION Remove the extension from the handpiece using the torque wrench supplied; Dispose of the extension in accordance with current national regulations governing hospital waste;

Connect the protection cap to the end part of the cord, at the connector cable gland; Insert the cap into the handpiece cord connector.

WARNING: Always install the protection cap before cleaning. WARNING: Before starting cleaning, always visually inspect the protection cap for any damage. Replace if any anomalies are seen.

reference table for procedures

REFERENCE TABLE FOR CLEANING AND STERILISATION PROCEDURES

This table is approximate only. For the complete procedures for cleaning and sterilising the individual parts, please refer to the paragraphs specified in the table.

WARNING: Do not use any methods not specified in the table below.

DANGER: 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.

Device Console and Foot Pedal

Phase

Paragraph

04.1

Step Manual cleaning with detergent

Accessories (Handpiece and Torque Wrench)

Phase

Paragraph

Step

Handpiece

Torque Wrench

04.2

Manual cleaning

04.3

Combined cleaning manual/automatic

04.4

Automatic cleaning

Washer/disinfector with detergent

III.

Checking cleaning

Visual inspection

IV.

Drying and lubrication

Sterilisation

Soaking in enzymatic detergent

II.

Soaking in detergent

Ultrasound cleaning

Soaking in enzymatic detergent Washer/disinfector with detergent

Drying

Drying + Lubrication

Packaging, sterilisation and stocking

CLEANING

Device console and foot pedal: The only cleaning method applicable is the manual method.

04.1

Accessories (Handpiece and torque wrench): The operator needs to choose from the following cleaning procedures: - Manual cleaning; - Combined manual/automatic cleaning; - Automatic cleaning. The procedures applicable to the Piezosurgery® medical accessories described in the following manual have been validated by an independent entity.

CLEANING THE device console AND FOOT PEDAL

PREPARATION - Check that all the following accessories have been removed/disconnected from the device (see Chapter 02): • electric power supply lead • irrigation kit • handpiece • irrigation bag support rod • supplementary equipotential cable connector (if present) • foot pedal

DANGER: Always turn the device off by means of the switch and disconnect it from the electric grid before cleaning or disinfecting. DANGER: The device console is not protected against the penetration of liquids. Do not spray liquids directly onto the surface of the device. WARNING: Do not soak the device console or foot pedal in liquids and/or solutions of other types. WARNING: Do not sterilise the device console or pedal. WARNING: Do not use machinery/ devices to clean the device console or foot pedal. WARNING: Do not rinse the electric contacts of the foot pedal under running water.

MATERIALS REQUIRED - Clean, soft lint-free cloths - Detergent (pH 6-9) and, if necessary, a non-aggressive neutral pH (pH 7) disinfectant solution

WARNING: If intending to disinfect, we recommend using water-based disinfectants with neutral pH (pH 7). Alcohol- and oxygenated waterbased disinfectant solutions are not recommended as they may discolour and/ or otherwise damage plastic materials. This also applies for chemical products such as acetone and alcohol.

cleaning

CLEANING AND DISINFECTING 1

Clean the device and foot pedal surfaces with a clean, soft lint-free cloth, imbued with a detergent solution (pH 6-9), following the manufacturer’s instructions;

If intending to use a disinfectant, use a non-aggressive neutral pH (pH7) solution prepared according to the manufacturer’s instructions; pH 6

-9

Dry the device body using a clean, non-abrasive, soft lint-free cloth;

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

04.2

CLEANING ACCESSORIES: MANUAL

PREPARATION

The process applies to the following accessories: - Handpiece; - Metallic front cone; - Torque wrench; After having disconnected the accessories, following the instructions given in chapter 02 of this manual, implement the cleaning procedure as described below.

WARNING: Before cleaning the handpiece, remove the insert. WARNING: Always install the protection cap before cleaning. WARNING: Before starting cleaning, always visually inspect the protection cap for any damage. Replace if any anomalies are seen. WARNING: Do not soak the handpiece in ultrasound tank.

MATERIALS REQUIRED - Enzymatic detergent; - Neutral pH cleaner; - Tap water; - Suitably-sized container; - Clean soft bristled, nylon brush; - Ultrasound tank; - Demineralised/distilled water; - Syringe; - Water jet pistol.

DANGER: Start the reprocessing procedures at the end of the intervention. Do not allow contaminated instruments to dry before reprocessing.

04 WARNING: 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.

cleaning

recommended as they may discolour and/or otherwise damage plastic materials. This also applies for chemical products such as acetone and alcohol. WARNING: Cleaning instruments. Use appropriate cleaning instruments as specified in this manual. Never use brushes, metallic sponges, abrasive instruments or sharp objects to remove residues during manual cleaning. These may ruin the product surface and permanently and definitively damage the instruments. Only use brushes with soft, nylon bristles.

WARNING: Use either tap water or demineralised water, as indicated by this manual.

WARNING: If intending to disinfect, we recommend using water-based disinfectants with neutral pH (pH 7). Alcohol- and oxygenated waterbased disinfectant solutions are not

WARNING: Dispose of the enzymatic detergent correctly once used. Do not recycle.

SOAKING IN ENZYMATIC DETERGENT HANDPIECE, FRONT CONE, TORQUE WRENCH 1

Prepare an enzymatic detergent solution* according to the manufacturer’s instructions;

* Process validated by independent body with enzymatic detergent Cidezime® (Enzol®).

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

WARNING: Do not soak the handpiece if warm.

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

Use a clean soft bristled, nylon brush under running water to clean thoroughly but without damaging the surfaces of the handpiece, front cone and torque wrench. Do this until all visible traces of soil have been removed. Also rinse the handpiece cord; DANGER: 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 threaded parts; Metallic front cone - The internal threaded part; Torque wrench - External metallic ring; - Internal channels and cavities; NOTE: Rinse the cavities, grooves and fissures and critical parts thoroughly. WARNING: To prevent the accumulation of enzymatic detergent residues, rinse the instrument surfaces thoroughly.

10 min

40°C

04 5

cleaning

Handpiece: Use a single-use syringe (min. 50 ml) to inject the enzymatic detergent solution into the cavities and internal channels of the handpiece three times in order to effectively remove the residues from the internal channel surfaces;

Rinse the internal channels, injecting cold distilled/demineralised water at a pressure of 3.8 bars for 10 seconds, to eliminate all enzymatic detergent residues; NOTE: Rinse the channel within the handpiece by injecting the liquid from the back, taking care to use a waste water container to avoid sprays. Leave the water to drain through the internal channel. Repeat the procedure until the rinsing water is free from residues.

SOAKING IN MILD DETERGENT - HANDPIECE, FRONT CONE 7

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

* Process validated by independent body with RenuKlenz® (Steris®) detergent

Place the handpiece and metallic front cone in a container. Add sufficient neutral pH cleaner solution to the container to completely cover the handpiece and front cone;

Use a clean soft bristled, nylon brush under running water to clean thoroughly but without damaging the surfaces of the handpiece and cone. Do this to remove all visible traces of contamination. Also rinse the handpiece cord;

Rinse the internal channels, injecting cold distilled/demineralised water at a pressure of 3.8 bars, to eliminate all detergent residues; NOTE: Rinse the channel within the handpiece by injecting the liquid from the back, taking care to use a waste water container to avoid sprays. Leave the water to drain through the internal channel. Repeat the procedure until the rinsing water is free from residues.

cleaning

ULTRASOUND CLEANING - TORQUE WRENCH 11

Prepare an enzymatic detergent solution* according to the manufacturer’s instructions and place it into an ultrasound bath;

* Process validated by independent body with enzymatic detergent Cidezime® (Enzol®)

10 min

Place the wrench into a suitable container (stainless steel washing machine tray with partitions). Place the tray in an ultrasound cleaner for 10 minutes at 40°C;

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

40°C

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;

04.3

CLEANING ACCESSORIES: COMBINED MANUAL/AUTOMATIC

The combined manual/automatic cleaning cycle must always be preceded by the manual cleaning stage described below.

PREPARATION The process applies to the following accessories: - Handpiece; - Metallic front cone; - Torque wrench; After having disconnected the accessories, following the instructions given in chapter 02 of this manual, implement the cleaning procedure as described below.

MATERIALS REQUIRED - Washer/disinfector; - Enzymatic detergent or alkaline solution and neutralising solution; - Tap water; - Suitably-sized container; - Clean soft bristled, nylon brush; - Demineralized/distilled water; - Syringe. WARNING: Alcohol-based disinfectant solutions and hydrogen peroxide are contra-indicated as they may discolour and/or otherwise damage plastic materials. This also applies for chemical products such as acetone and alcohol. Always rinse with sterile water to keep disinfection. WARNING: Cleaning instruments. Use appropriate cleaning instruments as specified in this manual. Never use brushes, metallic sponges, abrasive instruments or sharp objects to remove residues during manual cleaning. These may ruin the product surface and permanently and definitively damage the instruments. Only use brushes with soft, nylon bristles.

WARNING: Dispose of the detergent correctly once used. Do not recycle.

WARNING: When cleaning, 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.

cleaning

SOAKING IN ENZYMATIC DETERGENT HANDPIECE, FRONT CONE, TORQUE WRENCH 1

Prepare an enzymatic detergent solution* according to the manufacturer’s instructions;

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

Place the handpiece, metallic front cone and torque wrench in a container. Add sufficient enzymatic detergent solution to the container to completely cover the accessories; WARNING: Do not soak the handpiece if warm.

10 min

40°C

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

HANDPIECE: Use a single-use syringe (min. 20 ml) to inject the enzymatic detergent solution into the cavities and internal channels of the handpiece three times in order to effectively remove the residues from the internal channel surfaces;

Whilst soaking in the enzymatic detergent solution, gently brush the surface of the metallic front cone and wrench, using a clean soft bristled, nylon brush to eliminate all visible traces of soil;

Use a clean soft bristled, nylon brush under running water (minimum quality: tap water, temperature 20°C ± 2°C) to clean thoroughly but without damaging the surfaces of the handpiece, front cone and torque wrench. Do this for at least 30 seconds, until all visible traces of soil have been removed. Also rinse the handpiece cord;

DANGER: 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 threaded parts; Metallic front cone - The internal threaded part; Torque wrench - External metallic ring; - Internal grooves and cavities; NOTE: Rinse the cavities, grooves and fissures and critical parts thoroughly. WARNING: To prevent the accumulation of enzymatic detergent residues, rinse the instrument surfaces thoroughly.

Rinse the internal channels, injecting cold distilled/demineralised water from a disposable 20 ml syringe three times, to eliminate all enzymatic detergent residues; NOTE: Rinse the channel within the handpiece by injecting the liquid from the back, taking care to use a waste water container to avoid sprays. Leave the water to drain through the internal channel. Repeat the procedure until the rinsing water is free from residues.

cleaning

WASHER/DISINFECTOR HANDPIECE, FRONT CONE, TORQUE WRENCH 8

Lay the handpiece, metallic front cone and torque wrench in a metallic tray. Arrange the material in a washer/ disinfector into which the detergent solution and/or neutralising solution have been previously loaded, in accordance with the manufacturer’s instructions;

NOTE: Place the instruments in the washer/disinfector so that dead zones do not arise and the water can properly drain. Also, make sure that the handpiece and the metal front cone are properly held in place in the washing tray and cannot move during the washing process, as shocks could damage them. DANGER: Avoid overloading the washer/disinfector as this may compromise cleaning effectiveness. WARNING: Do not kink the handpiece cord; this may damage it.

9 __

It is possible to choose between two different cleaning cycles: neutral pH detergent cycle or alkaline detergent cycle.

NEUTRAL PH DETERGENT CYCLE* Sequence and parameters applicable to the cycle: - 3 mins., Pre-wash with cold water; - 5 mins., Washing with 0,5% neutral pH detergent at 45°C; - 2 mins., Rinsing with tap water; - 2 mins., Rinsing with cold demineralised water; - 5 mins., Thermodisinfection at 93°C with demineralised water. The automated thermodisinfection was not experimentally tested. According to standard ISO 15883-1, Table 2.1 [4] the thermodisinfection at a temperature of 90°C for 5 mins. determines an A0 value of 3000);

* Validated in compliance with standard ISO 15883-1 with Miele G 7735 CD Miscellaneous Programme TD; Detergent: Renu-Klenz® (Steris®).

WARNING: The automatic cleaning cycle, as described above, must always be preceded by the manual cleaning steps.

ALKALINE DETERGENT CYCLE* - 1 min, Pre-washing with cold water; - 5 min, Washing with alkaline detergent at 55°C ±2°C; - 1 min, Neutralization with proper solution (1/3 cold water, 2/3 warm water); - 1 min, Rinsing with water (1/3 cold water, 2/3 warm water); - 5 min, Thermodisinfection at 93°C with demineralized water. The automated thermodisinfection was not experimentally tested. According to standard ISO 15883-1, Table B.1 [4] the thermodisinfection at a temperature of 90°C for 5min determines an A0 value of 3000. WARNING: The automatic cleaning cycle, as described above, must always be preceded by the manual cleaning steps.

9 __

* Validated in compliance with standard ISO 15883-1 with Miele PG8535 Miscellaneous Programme TD: Detergent: Neodisher FA (0.2% v/v cleaning solution) and Neodisher Z (0.1% v/v neutralising solution).

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