Piezosurgery flex Use and Maintenance Manual Rev 01 Sept 2021

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 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 TABLE OF CONTENTS

1

Introduction

2

Identification Data

7

3

Delivery

9

4

First Installation

10

5

Use

15

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 1.3 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 9.4.1 9.4.2

II

Intended Use of PIEZOSURGERY® flex Description of the Device 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 Customer Service - Returns and/or Repairs Repairs Returned Goods

1

1 2 2 2 3 5 7 7 8

9

10 11 15 16 17 18 21 24

27 27 28 29 29 31 32 33

34 36 38 39 39 39



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flex

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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 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 as: 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.

1.1

•

Hand and foot surgery;

•

Otolaryngology surgery;

• • •

Oral/Maxillofacial surgery; Plastic/Reconstructive Surgery; Neurosurgery; Spine surgery.

The device may also be used with endoscopic visual assistance to perform the above listed procedures.

1

• •

check for any available updates in the section MANUALS of MECTRON website1; contact Piezosurgery Inc. Customer Service.

Intended Use of PIEZOSURGERY® flex

PIEZOSURGERY® flex is an ultrasonic surgical system consisting of handpieces and associated insert tips for cutting bone, osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to: •

The purpose of this manual is to ensure that operators are aware of the safety requirements, installation procedures, and instructions for correct use and maintenance of the device and its accessories. Using this manual for purposes other than those relating to the installation, use and maintenance of the device, is strictly prohibited. The information and illustrations contained in this manual are updated as of the date of publication specified on the last page. MECTRON is committed to the continuous updating of our products, which may entail changes to components of the device. In case you encounter discrepancies between the descriptions found in this manual and the equipment in your possession you can:

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. 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.

manuals.mectron.com

1

flex WARNING: The device must be used in a hospital environment, such as an operating theatre.

1.2

WARNING: Risk of explosion. The device cannot function in places where there is an atmosphere saturated with flammable gases (anaesthetic mixtures, oxygen, etc.).

Description of the Device

The PIEZOSURGERY® flex device is a piezoelectric ultrasonic bone cutting instrument: the device uses piezoelectric ultrasonic technology to generate mechanical micro-vibrations which allow the cutting of mineralized structures with minimal trauma to soft tissues. The equipment has an automatic tuning circuit

1.2.1

Users

1.3

Disclaimer

that offsets wear of the inserts, thus ensuring work in constant conditions of maximum efficiency. The user interface has been optimized with PIEZOSURGERY® flex making all the functions readily available by integrating them in the touch keyboard.

U.S. Federal law restricts this device to sale by or on the order of a licensed physician.

The manufacturer Mectron and the distributor, Piezosurgery Inc. 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 and the distributor, Piezosurgery Inc. 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.

2

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

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 device is not used in compliance with all the instructions and precautions described in this manual; 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 Piezosurgery Inc.; Improper use, mistreatments, and/or

7. 8.

9.

incorrect interventions;

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

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

Introduction 1.4

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. The user should take whatever steps are necessary to eliminate or reduce the source of interference. Install the PIEZOSURGERY® flex at safety distance from life-support systems. The PIEZOSURGERY® flex must not be used adjacent or stacked with other electrical equipments. If adjacent or stacked use of the device is necessary, normal operation of the equipment and the PIEZOSURGERY® flex, in the configuration in which they will be used, should be verified prior their use. WARNING: Contraindications. Interference by other equipment. An electro-surgical knife of other electro-surgical units near the PIEZOSURGERY® flex device may interfere with its correct operation. 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 make sure that there is no water underneath the device. Before each treatment, always make sure that the device and accessories are in proper working order. If anything unusual is noted during operation, do not carry out the treatment. If the problem concerns the device, contact Piezosurgery Inc. Customer Service. WARNING: The electrical supply network to which the device is connected must comply with all the applicable standards and with electrical safety requirements. WARNING: To avoid risk of electric shock, this device must be grounded. Only connect the console to hospital grade receptacle to ensure electrical grounding reliability. WARNING: Do not operate the foot pedal of the PIEZOSURGERY® flex when the peristaltic pump cover is open. Moving parts might pinch loose clothing or fingers. Personal injuries may result. WARNING: Personal injury. Make sure that power cables do not interfere with free circulation of people in the area. CAUTION: Federal Law (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 operate the device if the handpiece is defective, damaged or broken. Replace the handpiece immediately. WARNING: Only use original Piezosurgery/Mectron inserts, accessories and spare parts. CAUTION: No modification of this equipment is allowed.

3

flex 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.

CAUTION: Allow reusable, autoclavable accessories to gradually return to room temperature after steam sterilization and prior to usage. The cooling process must not be accelerated.

CAUTION: Contraindications. Do not carry out any treatments on metal or ceramic prosthetic artifacts. The ultrasonic vibrations could cause decementation of such artifacts.

WARNING: Breakage and wear-out of the inserts. In rare cases, high frequency oscillations and wear-out may lead to breakage of an insert. 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. Unremoved fragments may cause tissue damage to the patient. Do not modify the insert in any way, otherwise its performance could be diminished. Bending, prying or deforming the insert may cause it to fracture. These inserts must never be used. Re-sharpening the insert damages it and is therefore forbidden. Always inspect the insert before and during the operation especially in its apical part for any damage. If damaged is observed replace with a new insert. During surgery, avoid prolonged contact with retractors or other metal objects being used, otherwise the insert may break. Do not exert excessive pressure on the inserts during their use, otherwise it may fracture resulting in harm to the patient or users.

WARNING: Single-use accessories. Inserts and irrrigation kit are provided for single-use only and must be used on an individual patient during a single surgical procedure and then discarded.Do not attempt to reuse or re-sterilize these singleuse items. WARNING: Control of infections Reusable Accessories First Use The reusable accessories (brand new or returned by service) are delivered in NON-STERILE condition and must be cleaned and sterilized prior to use by applying the procedures described in the Cleaning and Sterilization manual provided with the device. Every use Once used, each reusable accessory must be thoroughly reprocessed prior to reuse, according to the procedures described in the Cleaning and Sterilization manual provided with the device.

4

Introduction 1.5

Symbols Symbol

0051

I

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

5

flex Symbol

IPX8

QTY.1

Description

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.

6

Symbol

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

Identification Data

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 Piezosurgery Inc. Customer Service.

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

made in Italy

Rx Only

2.1

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 5.

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 8): •

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 5.

7

03120127

0051

flex

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);

•

•

8

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

Delivery

3

DELIVERY

3.1

List of the Components of the PIEZOSURGERY® flex

Refer to the front endpaper. The PIEZOSURGERY® flex device is supplied as of a set of equipment, as follows: A. B. C. D. E. • •

Console with an integrated peristaltic pump; Drip stands for supporting the saline bags;

Power supply cable with hospital grade plug; Foot Pedal with bracket, cord and connector; Case;

1 x Instructions for Use manual;

1 x Instructions for cleaning and sterilizing manual.

The following accessories are sold separately from the PIEZOSURGERY® flex device: F.

G. H.

PIEZOSURGERY® medical single-use inserts (supplied sterile); PIEZOSURGERY® medical single use irrigation kit (supplied sterile);

PIEZOSURGERY® medical handpiece complete with cord and the connector protective cap (supplied NON sterile and reusable);

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 Piezosurgery Inc. have been inspected upon they delivery. 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 Piezosurgery Inc. Customer Service 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, irrigation kit) available to use in case the device stops due to a fault or of inconveniences.

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

PIEZOSURGERY® medical torque wrench (supplied NON sterile and reusable).

9

4

flex

FIRST INSTALLATION

To ensure correct operation of the device, it must be installed by a person authorized by Piezosurgery Inc. The device must be installed in a suitable place that is handy for its use. The device must be installed in a comfortable place suitable for its use.

4.1

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. The user should take whatever steps are necessary to eliminate or reduce the source of interference. Install the PIEZOSURGERY® flex at safety distance from life-support systems. The PIEZOSURGERY® flex must not be used adjacent or stacked with other electrical equipments. 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 electro-surgical knife of other electro-surgical units near 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.). WARNING: The electrical supply network to which the device is connected must comply with all the applicable standards and with electrical safety requirements. WARNING: To avoid any risk of electric shock this device must be grounded. Only connect the console to hospital grade receptacle to ensure electrical grounding reliability.

10

Position the device in way so that the power plug is always, easily reachable, since this plug is considered as a disconnecting means. The installation form has to be filled and sent to Mectron S.p.A. to ensure traceability and the warranty activation.

WARNING: Do not operate the foot pedal of the PIEZOSURGERY® flex when the peristaltic pump cover is open. Moving parts might pinch loose clothing or fingers. Personal injuries may result. 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. Adequate air circulation is needed to cool electronic components inside of the unit. Do not block the cooling fans at the console area and at the console bottom. Do not place the unit on a towel, foam or other soft surface since the material might block the air vent on the console bottom. 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: The electrical contacts inside the cord connector must be dry. Upon completion of the sterilisation cycle and before connecting the handpiece cord to the console, make sure that the electrical contacts of the connector are perfectly dry. If necessary, dry the contacts by blowing air onto them with medical 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.

First Installation CAUTION: No modification of this equipment is allowed.

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;

NOTE: The foot pedal comes equipped with a bracket that allows it to be moved to the place most suitable for the operation, without the need to use your hands to move it.

1

2

3

The bracket can also be positioned horizontally if it is not used;

11

flex Connect the foot pedal to the back of the device in the socket marked with the symbol , by means of the plug of the pedal cable, until you hear a “click” sound. In order to disconnect the foot pedal from the device grab the connector of the foot pedal, press the release flap and pull the connector back;

4

NOTE: MANUAL START STOP BUTTON In the case of foot-pedal failure intraoperatively, the button allows the operative staff to manually turn handpiece operation on and off. The button is located on the back of the device’s console, next to the peristaltic pump case, above the symbol marked . Refer to Chapter 5.3 on page 17. Fit the drip stand for supporting the solution bag into the dedicated hole;

STEPS TO BE CARRIED OUT IN THE “STERILE AREA”: Open the sterile package of the handpiece and of the irrigation kit, remove the tube and the clips; Connect the end of the irrigation tubing onto the dedicated handpiece irrigation nozzle; Use the 6 clips provided in order to clip together the irrigation tubing and handpiece cable;

12

5

6

First Installation STEPS TO BE CARRIED OUT IN THE “NOT STERILE AREA”: •

Open the pump cover completely;

•

Insert the part of the irrigation tube with a bigger diameter and with length of 15 cm into the peristaltic pump;

7

8

WARNING: Use only original Piezosurgery/Mectron accessories. Do not use irrigation tubings other than those supplied by Piezosurgery/Mectron. •

Close the pump cover completely;

WARNING: Do not operate the foot pedal of the PIEZOSURGERY® flex when the peristaltic pump cover is open. Moving parts might pinch loose clothing or fingers. Personal injuries may result. Hang the saline bag to its specific drip stand; Remove the protective cap from the spike and connect it to the irrigation bag;

9

WARNING: The irrigation bag support rod must be used with bags of up to a maximum of 1000 ml. WARNING: The PIEZOSURGERY® Medical irrigation kit is provided in sterile packaging. Inspect the packaging to check its integrity. Whether it results damaged, DO NOT use the product and proceed with the proper disposal.

13

flex Open the air inlet on the tube before operating. Release the irrigation tube clamp, if this is closed;

With the marked dot facing upward, insert the connector of the handpiece cord into the handpiece socket on the console. Gently push the handpiece-cord connector until it bottoms out. CAUTION: To avoid damaging the handpiece-cord, hold only the connector when disconneting the cord. Always hold the cord by its connector. Never pull on the cord itself.

14

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11