Piezosurgery flex Use and Maintenance Manual Rev 05 Sept 2021

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USE AND MAINTENANCE MANUAL

flex

flex

 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 SUMMARY

1

Introduction

2

Identification Data

8

3

Delivery

10

4

Installation

11

5

Use

16

6 7 8

Maintenance Disposal Method and Precautions Technical Specifications

25 25 26

9

Troubleshooting

34

10

Warranty

40

1.1 1.2 1.2.1 1.2.2 1.2.3 1.2.4 1.3 1.4 1.5 2.1 2.2 2.3 3.1 4.1 4.2 5.1 5.2 5.3 5.4 5.5 5.6

8.1 8.1.1 8.1.2 8.1.3 8.1.3.1 8.1.3.2 8.1.3.3 8.1.4 9.1 9.2 9.3 9.4

II

Intended Use Description of the Device Patient Group Directions Patient Selection Criteria Indications for Use Users Disclaimer Safety Precautions Symbols Device Identification Label Handpiece Identification Data Inserts Identification Data List of the Components of the PIEZOSURGERY® flex

Safety Requirements in the Installation Phase Connecting the Accessories Switching the Device On and Off Description of the Keyboard Foot Pedal Button Safety Requirements Before and During Use Instructions for Use Important Information on Inserts

Electromagnetic Compatibility IEC/EN 60601-1-2 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions Accessible Parts of the Casing Guidance and Manufacturer’s Declaration - Electromagnetic Immunity Power Connection A.C. Input Points of Contact with the Patient Parts Accessible to the Input / Output Signals Specifications of the tests for the Immunity of the Accessible Parts of the Casing to the Wireless RF Communications Device Diagnostic System and Symbols on Keyboard Troubleshooting Quick Guide Fuses Replacement Sending to an Authorized Mectron Service Centre

1 1 2 2 2 2 3 3 4 6 8 8 9

10

11 12

16 17 18 19 22 24

27 27 28 29 29 31 32 33

34 36 38 39



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IV

Introduction

1

INTRODUCTION

Carefully read this manual before proceeding with installation operations, use, maintenance or other intervention operations on the device. Always keep this manual at hand. Important: To avoid damages to persons or things, read with particular attention all the chapters “Safety Requirements” present in the manual. According to the degree of severity the safety requirements are classified with the following indications: WARNING: (Always referred to damage to persons) CAUTION: (Referring to possible damages to things) The aim of this manual is to make the operators aware of the safety regulations, installation

1.1

•

Otolaryngology;

•

Hand and foot Surgery;

•

Oral/Maxillofacial Surgery; Plastic/Reconstructive Surgery.

It may also be used with endoscopic assistance to perform the above listed procedures. WARNING: Use the device only for the intended use. Failure to meet these requirements may cause serious injuries to the patient, the operator, and damages/ breakdowns of the device.

1

• • •

check for any available updates in the section MANUALS of MECTRON website1; ask clarifications to Your Dealer;

contact MECTRON After Sales Service.

Intended Use

PIEZOSURGERY® flex is a piezoelectric surgical system intended for use in bone cutting, equipped with special insert tips to perform osteotomy, osteoplasty and drilling in a variety of surgical procedures: •

procedures, instructions for proper use and maintenance of the device and its accessories. Use of this manual for aims other than those strictly linked to the installation, use and maintenance of the device is prohibited. The information and illustrations in this manual were updated on the edition date shown on the last page. MECTRON is engaged in continuously updating its products with possible changes to the components of the apparatus. In case you encounter discrepancies between the descriptions found in this manual and the equipment in your possession you can:

WARNING: Carefully read this manual and follow its recommendations in order to avoid to compromise the patient and/ or the user safety. Failure to meet these requirements may cause serious injuries to the patient and/or the operator. WARNING: Qualified and specialized personnel. The device must be used exclusively by specialized personnel such as Surgeon. To use the device no special training is requested. The use of the device does not cause side effects if it is used correctly. An improper use might cause tissues heating. WARNING: The device must be used in a hospital environment, such as an operating theatre. WARNING: Risk of explosion. The device cannot function in places where there is an atmosphere saturated with flammable gases (anaesthetic mixtures, oxygen, etc.).

manuals.mectron.com

1

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1.2

Description of the Device

The user interface has been optimized with the PIEZOSURGERY® flex making all the functions readily available by integrating them in the touch keyboard. The PIEZOSURGERY® flex is a device that uses ultrasonic piezoelectric technology to generate mechanical microvibrations of the inserts, to effectively cut mineralized tissues. This allows an efficient and safe cutting which preserves the integrity of the osteotomized surfaces. The micrometric, ultrasonic vibrations of the inserts provide greater precision and a selective cutting action compared to

1.2.1

traditional methods such as drills or oscillating saws (which act with macrovibrations), therefore minimizing traumatic effect on soft tissues. The cavitation effect of the irrigating solution helps to keep the operatory field blood-free. This provides an optimal intra-operatory visual control thus increasing safety, even in areas that are anatomically most difficult to access. This medical device can be used on any patient of any age, weight, height, gender and nationality.

Patient Group Directions

This medical device is designed to be used with the following patient population: •

Infants;

•

Adolescents;

• • •

Children;

This medical device can be used on any patient of any age, weight, height, gender and nationality.

Adults;

Elderly.

1.2.2

Patient Selection Criteria

The use of the device is not recommended in the following cases: 1.

2.

3. 4.

Patients with active implantable medical devices (for example: pacemakers, hearing aids and/or other electromagnetic prostheses) without the prior authorization of their doctor; Women who are pregnant or breastfeeding, due to the restrictions associated with the possible use of medical solutions such as anaesthetics Patients with allergies;

Patients with pathologies or clinical conditions for which it is not recommended to perform surgery

1.2.3

Indications for Use

5.

or for which it may represent a contraindication according to the treating physician. These conditions may include, but are not limited to: heart disease, diabetes, cirrhosis, HIV infection, pregnancy or breastfeeding, radiation therapy, chemotherapy, immuno-suppressive therapy, allergies and psychiatric disorders;

Patients with unsuitable treatment sites.

All models of “Piezosurgery” bone surgery devices are intended for professional use only. Therefore, the user is the only person able to decide if and how to treat their patients.

The use of the device is suitable for all the appropriate patients (see chapter above) for whom a bone surgery treatment is prescribed, by the treating physician, within the intended use of the device (see Chapter 1.1 on page 1).

2

Introduction 1.2.4

Users

1.3

Disclaimer

The device must be used only by specialised and properly trained personnel, such as a surgeon physician, able-bodied adults of any weight, age, height, gender and nationality.

The manufacturer Mectron disclaim any liability, expressed or implied, and shall have no responsibility for any direct, indirect or other damages and personal injury arising out in connection with any improper practice in the use of the device and its accessories. The manufacturer Mectron shall be under no liability, expressed or implied, with respect to any damages (personal injury and/or damage to property) which might arise or be caused, whether by the customer or by any of the users of the product and its accessories, as result of: 1. 2.

3. 4.

5.

6.

Procedures different than those specified in the intended use of the product;

7.

The device is not used in compliance with all the instructions and precautions described in this manual;

9.

The environmental conditions for the preservation and storage of the device are not compliant with the precautions indicated in the Chapter 8 on page 26;

The electrical system of the relevant operating room is not compliant with the applicable regulations and with electrical safety requirements;

The assembly operations, extensions, adjustments, updates, and repairs on the device are performed by personnel not authorized by Mectron;

8.

Any and all attempts to tamper with or modify the device, under any circumstance;

Use of non-original Mectron inserts that damage the threading of the handpiece, thus compromising correct operation and causing risk of harm to the patient;

Use of non-original Mectron inserts, even if they are used in accordance to designed and tested settings of Mectron original inserts. The correct use of the settings is guaranteed only with original Mectron inserts;

10. Lack of stock materials (handpiece, inserts, wrenches) to be used in the event of device stop due to fault or of inconveniences.

Improper use, mistreatments, and/or incorrect interventions;

3

1.4

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Safety Precautions

WARNING: Risk of explosion. The device cannot operate in environments where the atmosphere is saturated with flammable gases (anaesthetic mixtures, oxygen, etc.). WARNING: Contraindications. Interference with other equipment. The PIEZOSURGERY® flex device complies with the standard IEC 60601-1-2. However, it may interfere with other devices in its vicinity. Install PIEZOSURGERY® flex at safety distance from life-support systems. If adjacent or stacked use of the device is necessary, normal operation of the equipment and PIEZOSURGERY® flex, in the configuration in which they will be used, should be verified prior their use. WARNING: Contraindications. Interference by other equipment. An electrosurgical knife of other electrosurgical units placed in the vicinity of the PIEZOSURGERY® flex device may interfere with its correct functioning. CAUTION: In the case the hospital must subject the electro-medical equipment and systems to periodical inspections in order to adhere to imposed requirements in its own structure, the test procedures that must be applied to electro-medical equipment and systems to evaluate safety must be performed in line with norm EN 62353 ‘Electro-medical devices - Periodical inspections and tests to be performed after repair interventions on electro-medical devices’. The interval for periodic checks, in the intended operating conditions and described in this “Use and Maintenance” manual, is one year.

WARNING: Checking device status before the treatment. Always check that there is no water underneath the device. Before every treatment, always check that the device works perfectly and that the accessories are efficient. If anything unusual is noted during operation, do not perform the treatment. If the problem concerns the device, contact an Authorized Mectron Service Center. CAUTION: The electrical system of the relevant operating room, where the device is installed and used, must comply with the applicable regulations and with electrical safety requirements. CAUTION: To avoid risk of electric shock, this device must be grounded. WARNING: Do not operate the foot pedal of the PIEZOSURGERY® flex when the peristaltic pump cover is open. Moving parts could injure the operator. WARNING: Personal injury. Take care to ensure that cables do not hinder the free movement of personnel. CAUTION: US Federal Law (of the United States of America) restricts this device to sale by or on the order of a physician. WARNING: Prior to any use, system components should be inspected for damage. Do not use if damage is apparent. WARNING: Do not activate the device if the handpiece is faulty, damaged or broken. Replace the handpiece immediately. WARNING: Only use original Mectron accessories and spare parts. CAUTION: No modification of this equipment is allowed. WARNING: Contraindications. Do not use PIEZOSURGERY® flex on patients with heart stimulators (Pace-makers) or other implantable electronic devices. This precaution also applies to the operator.

4

Introduction CAUTION: Contraindications. Do not perform treatments on prosthetic artifacts made of metal or ceramics. The ultrasonic vibrations could lead to the de-cementing of the artifacts. WARNING: Infection control. To ensure maximum safety of the patient and the operator, verify the reusable parts and accessories has been cleaned and sterilized prior to use, following the instructions of the Cleaning and Sterilization Manual. WARNING: Cleaning and sterilisation of new or repaired tools. All new and repaired reusable device accessories are supplied non-sterile. Before first use, and after each treatment, they must be cleaned and sterilised in strict compliance with the instructions given in the Cleaning and Sterilisation Manual. CAUTION: Contraindications. When the reusable items (the handpiece, the torque wrench, and any other accessory that can be sterilized ) have been autoclave sterilized, wait for them to cool down to room temperature prior to usage. The cooling process must not be accelerated.

WARNING: Breakage and wear-out of the inserts. In rare cases, high frequency oscillations and wear-out may lead to breakage of an insert. Deformed or otherwise damaged inserts are susceptible to breakage during their use. These inserts must never be used. Should an insert fracture during use, extreme care must be exercised to ensure that all the fragments of the insert are retrieved and removed from the surgical site and, at the same time, that an effective suction is applied. During surgery, frequently check that the insert is intact, especially in its apical part. During surgery, avoid prolonged contact with retractors or other metal objects being used. During surgery, do not apply excessive pressure on the inserts. WARNING: If an adverse event and/or serious accident attributable to the device occurs during correct and intended use, it is recommended to report it to the Competent Authority and to the manufacturer indicated on the product label.

5

1.5

Symbols Symbol

0051

I

6

flex

Description

Symbol

Description

Device compliant with Regulation (EU) 2017/745. Notified body: IMQ S.p.A.

Nemko Mark UL CSA compliance

Medical Device

Caution, read the Instructions For Use

Operating Instructions

Manufacturer

Date of manufacture

Serial Number

Lot Number

Product Number

Single-Use

Do not resterilize

Use-by date

Sterilized with Ethylene Oxide (EO)

Non-sterile

Can be sterilized in autoclave up to a maximum temperature of 135° C

Type “B” applied part as per EN 60601-1 recommendation

Equi-potentiality

Alternating Current

Connection of the foot pedal

Activation switch “on”

0

Activation switch “off”

Functional earth

Caution, risk of electric shock

Biohazard

The device and its accessories must not be disposed of or treated as solid urban wastes

Introduction Symbol

IPX8

QTY.1

Description

Symbol

Description

General warning a)

Do not touch moving parts b)

Temperature limitation for transport and storage

Humidity limitation for transport and storage

Atmospheric pressure limitation for transport and storage

Do not use if package is damaged

International Protection Code of the mechanical casing. Liquid ingress protection.

IP20

International Protection Code of the mechanical casing.

Quantity of items in the package: 1

Rx Only

For US market, only. CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed physician

Table 1 – Symbols a) The symbol is represented by a yellow warning triangle and a black graphical symbol.

b) The symbol is represented by a red circle-with-slash and a black graphical symbol.

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2

IDENTIFICATION DATA

A precise description of the model and device serial number will facilitate the After-Sales Service to answer the inquiries quickly and effectively. Always provide this information when contacting an Authorised Mectron Service Centre.

Device Identification Label

Every device has an identification label that reports the main technical characteristics and the serial number. The identification label is located under the device. The complete technical specifications are reported in Chapter 8 on page 26.

manufacturer Mectron S.p.A. Via Loreto 15/A 16042 Carasco -GE- Italy

PIEZOSURGERY flex 100-240 V~ 120 VA - 50/60 Hz.

00000000

413000000

0051

YYYY-MM-DD

HIBC 128 Bar Code

A separate label shows further symbols and characteristics of the device. This identification label is placed under the device. NOTE: The complete list of symbols and their description are shown in Chapter 1.5 on page 6.

2.2

PIEZOSURGERY flex Device for intermittent operation: 60 s ON - 30 s OFF with irrigation

Handpiece Identification Data

Each handpiece is laser-marked with (refer to Figure 1 at page 9): •

its serial number (SN);

•

its date of manufacturing;

• • • • •

its product number (REF);

the device name (PIEZOSURGERY® medical); the Mectron logo;

HIBC 128 Data Matrix;

CE, MD, Applied Part and Sterilizable symbols.

NOTE: The complete list of symbols and their description are shown in Chapter 1.5 on page 6.

8

made in Italy

Rx Only

2.1

03120127

0051

Identification Data

YYYY-MM

408000000

HIBC 128 Data Matrix

medical

PIEZOSURGERY® medical Figure 1 – Handpiece Identification Data

2.3

Inserts Identification Data

the name of the insert (Ref. 1);

•

the lot number to which the insert belongs (Ref. 3);

•

•

the Mectron logo (Ref. 2);

the symbols “Single-use” and “CAUTION: read the instructions for use” (Ref. 4)

1

A A/XXXXX

•

MT1-10

The following data are laser-marked on each insert:

2

3

4

9

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3

DELIVERY

3.1

List of the Components of the PIEZOSURGERY® flex

Refer to the front endpaper. PIEZOSURGERY® flex consists of: A.

Device core system;

C.

Stand for Solution Bag;

B.

D. E. F.

G.

Peristaltic pump;

Use and Maintenance Manual, Cleaning and Sterilization Manual; Power Cord;

Foot Pedal with bracket, cable and connector; Case.

Available accessories: H.

PIEZOSURGERY® medical handpiece complete with cord and the connector protective cap (produced by Mectron);

CAUTION: The handpiece and the cord cannot be separated. I. J. K.

10

PIEZOSURGERY® medical single-use inserts (produced by Mectron);

PIEZOSURGERY® medical single use irrigation kit (distributed by Mectron); PIEZOSURGERY® medical torque wrench (produced by Mectron).

PIEZOSURGERY® flex consists of accessories that can be ordered separately. The packaging of the device cannot undergo strong impacts as contains electronic components, therefore the transport and the storage must be carried out with particular care. All material shipped by Mectron is controlled at the time of dispatch. The device is shipped appropriately protected and packaged. Upon receipt of the device, check for any possible damage caused during transport and in case any damage and/or defects is found, complain to the transporter. Keep the packaging in case there is a necessity to send any item to a MECTRON Authorized Service Centre and to store the device during long periods of inactivity. WARNING: Before starting to operate with the device, make sure that you have stock material (handpiece, inserts, wrenches) available to use in case the device stops due to a fault or of inconveniences.

Installation

4

INSTALLATION

To guarantee proper device functionality, it must be installed by an authorised Mectron technician. The device must be installed in a suitable and convenient place for its use. The technician will need to carry out the following 6 steps: 1. 2.

4.1

Unpack the device;

Explain to the user what precautions need to be taken to ensure correct installation;

3. 4. 5. 6.

Explain to the user all the possible device configurations; Explain how to clean, sterilise and maintain the system;

Fill in the installation and hospital personnel training forms;

Send Mectron the completed forms to guarantee traceability of the device and the activation of the warranty.

Safety Requirements in the Installation Phase

WARNING: Contraindications. Interference with other equipment. The PIEZOSURGERY® flex device complies with the standard IEC 60601-1-2. However, it may interfere with other devices in its vicinity. Install PIEZOSURGERY® flex at safety distance from life-support systems. If adjacent or stacked use of the device is necessary, normal operation of the equipment and PIEZOSURGERY® flex, in the configuration in which they will be used, should be verified prior their use. WARNING: Contraindications. Interference by other equipment. An electrosurgical knife of other electrosurgical units placed in the vicinity of the PIEZOSURGERY® flex device may interfere with its correct functioning. WARNING: Risk of explosion. The device cannot operate in environments where the atmosphere is saturated with flammable gases (anesthetic mixtures, oxigen, etc.). CAUTION: The electrical system of the relevant operating room, where the device is installed and used, must comply with the applicable regulations and with electrical safety requirements. CAUTION: To avoid risk of electric shock, this device must be grounded.

WARNING: Do not operate the foot pedal of the PIEZOSURGERY® flex when the peristaltic pump lid is open. Moving parts could injure the operator. WARNING: Install the device in a place protected against impacts or accidental splashes of water or other liquids. WARNING: Do not install the device on top of or close to sources of heat. When installing, make sure that adequate air circulates around the device. Leave sufficient room around it, with particular reference to the fan on the rear. CAUTION: Do not expose the device to direct sunlight or sources of UV light. CAUTION: The device is transportable but must be handled with care when moved. Position the footswitch on the floor in such a way that it can only be activated intentionally by the operator. CAUTION: Before connecting the handpiece cord to the device, make sure that the electrical contacts are perfectly dry. If necessary, dry them with compressed air. CAUTION: Do not allow the device console and the foot pedal to get wet. If liquid enters the console or footswitch, damage could occur. CAUTION: No modification of this equipment is allowed.

11

flex WARNING: Before using the PIEZOSURGERY® Medical irrigation kit, check the integrity of the sterile packaging and inspect the product to exclude the presence of any damage. Do not use the irrigation kit if the packaging is open or damaged. The irrigation set loses sterility if the packaging is broken or damaged. If the packaging is damaged or unintentionally opened before the use, proceed with the disposal of the set. The product cannot be re-sterilized or reused.

CAUTION: Position the device in way so that the power plug is always, easily reachable, since this plug is considered as a disconnecting means.

4.2

Connecting the Accessories

Equipotential plug: The device is equipped with an additional equipotential plug located on the rear of the console. This plug is in accordance with DIN 42801. Insert the connector of the equipotential cord (optional) to the plug on the rear of the device’s console. The purpose of additional potential equalization is to reduce differences of potential which can occur during operation between the device’s body and conductive parts of other objects within the medical environment; Plug the power supply cord into the power socket on the back of the device and then into the mains power outlet;

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1

2