starlight s x5 Use and Maintenance Manual Rev 11

starlight s x5

 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

starlight s x5 SUMMARY

1

Introduction

2

Identification Data

6

3

Delivery

7

4

Use

8

5

Cleaning, Disinfection and Sterilisation

11

6 7 8

Disposal Procedures and Precautions Symbols Troubleshooting

13 14 15

9

Technical Specifications

17

10

Warranty

26

1.1 1.2 1.2.1 1.2.2 1.2.3 1.2.4 1.3 1.4 2.1 3.1 4.1 4.2 4.3 4.4 4.5 5.1 5.2 5.3 5.4

8.1 8.2 8.3 9.1 9.1.1 9.1.2 9.1.3 9.1.3.1 9.1.3.2 9.1.3.3 9.1.4

II

Intended Use Description of the Device Patient Group Directions Patient Selection Criteria Indications for Use Users Disclaimer Safety Requirements Identification Data of the Handpiece

List of Components Connecting the Accessories Descriptions of Commands and Signalling Safety Requirements During Use Instructions for Use Safety Protection

Cleaning and Disinfecting the Handpiece Sterilisation Procedure Cleaning, Disinfection e Sterilisation of the Optical Fibre Cleaning, Disinfection e Sterilisation of the Optical Protection

Quick Troubleshooting Guide Diagnostic System and Possible Solutions How to Prepare the Device and the Accessories Before Sending them to Repair 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

1 2 2 2 2 3 3 3 4 6

7

8 9 10 10 11 11 12 13 13

15 15 16

18 18 19 20 20 22 23

24



III

starlight s x5

PAGE INTENTIONALLY LEFT BLANK

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 paragraphs “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 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: •

check for any available updates in the section MANUALS of MECTRON website1;

•

contact MECTRON After Sales Service.

•

1

ask clarifications to Your Dealer;

https://manuals.mectron.com/

1

starlight s x5 1.1

Intended Use

Polymerisation of photo-hardening dental materials with a photoinitiator that can be activated in the wavelength band comprised between 440 and 480 nm. Although most composite materials are activated within this wavelength range, in case of uncertainty consult the specifications of the composite material or contact the manufacturer. This equipment may be used only in a dentist’s surgery or out-patient’s department where there are no inflammable gases (anaesthetic mixtures, oxygen, etc.).

1.2

Description of the Device

starlight s x5 is an equipment for polymerising photo-hardening composites. The light source used is a very high-efficiency monochromatic LED with a dominant wavelength between 440 nm and 465 nm. Unlike traditional halogen lamps, therefore, all the light being emitted by starlight s x5 is used to activate the camphorquinone photoinitiator. Furthermore, the light emitted by the diode is focused on the optical fibre by means of an optical elements, the shape of which was designed specifically for this purpose. The starlight s x5 can be used to operate in either of two emission modes: • •

Constant intensity of emission - FAST (cycle lasting 10 seconds);

Gradual intensity of emission - SLOW RISE (cycle lasting 20 seconds).

1.2.1

Patient Group Directions

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

Children;

•

Adults;

• •

Adolescents; Elderly.

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

1.2.2

Patient Selection Criteria

The use of the device is not recommended in the following cases: 1. 2. 3.

Patients with active implantable medical devices (for example: pacemakers, hearing aids and/or other electromagnetic prostheses) without the prior authorization of their doctor; Patients with a history of light stimulation, for example in photoexposure dermatitis and/ or porphyrias, etc. or who are being treated with photosensitizing drugs. In all cases of possible risk, consult a specialist doctor; Patients whose medical history shows pathologies of the retina must first consult the ophthalmologist to receive authorization for treatment with the Mectron curing light.

WARNING: Adopt strict safety measures for patients who have undergone cataract surgery and are therefore particularly sensitive to light (for example, safety glasses that filter out blue light). All models of curing lights are intended for professional use only. Therefore, the user is the only person able to decide if and how to treat their patients.

2

Introduction WARNING: Contraindications. In all cases of potential risk, a specialist doctor must be consulted.

1.2.3

Indications for Use

1.2.4

Users

1.3

Disclaimer

The use of the device is indicated for all the intended patients (see Chapter 1.2.1 on page 2) for whom a polymerization treatment of light-curing dental materials is prescribed, by the treating physician, within the intended use of the device (see Chapter 1.1 on page 2). The device must be used only by specialised and properly trained personnel, such as the dentist and/or assistant, adults of any weight, age, height, gender and nationality, able-bodied. No specific training activities are required for the use of the device.

The manufacturer MECTRON disclaims all responsibility, express or implied, and cannot be held responsible for direct or indirect personal injury and/or property damage, occurring as a result of incorrect procedures linked to the use of the device and its accessories. The manufacturer MECTRON cannot be held responsible, expressly or by implication of any type of injury to persons and/or damage to things, carried out by the user of the product and its accessories and happened by way of example and not of limitation, in the following cases: • • • • • • • • •

Misuse or use during procedures other than those specified in the destination of use of the product; The environmental conditions for preservation and storage of the device are not complying with the requirements indicated in Chapter 9 on page 17;

The device is not used in accordance with all the instructions and requirements described in this manual; The electrical system of the places where the equipment is used do not comply with the laws in force and the related regulations;

Assembly operations, extensions, re-adjustments, upgrades and repairs of the device are carried out by personnel not authorized by MECTRON; Misuse, abuse, abnormal use, negligent use, intentional misconduct or use exceeding the limits of the device indicated and allowed and/or normal wear or deterioration, illtreatment and/or incorrect interventions; Any attempt to tamper with or modification of the device under every circumstance;

Breach of the requirements and the information contained in Chapter 5 on page 11 of this manual;

Unauthorized repairs in accordance with the indications contained in Chapter 10 on page 26 of this manual.

3

starlight s x5 1.4

Safety Requirements

CAUTION: No alterations to this device are permitted. CAUTION: The electrical system of the premises in which the device is installed and used must comply with the rules in force and the relevant requirements of electrical safety. WARNING: Qualified and specialised personnel. The device must be used exclusively by specialized personnel with proper medical culture; no training activities are foreseen for the use of the device. The use of the device does not cause side effects if it is used correctly. WARNING: Intended use. Use the equipment solely for the purpose for which it is intended (see Chapter 1.1 on page 2). Failure to comply with this requirement could lead to serious harm to the patient and/or to the operator and/or damage to/failure of the equipment. WARNING: Contraindications. Do not use the device on patients with Pacemakers or other implantable electronic devices. This regulation also applies to the operator. WARNING: Point the beam of light directly at the material to be polymerised. Do not point the beam of light on the gums or other soft tissues (if necessary these parts should be suitably shielded). The effect of the light should be limited to that part of the oral cavity to be clinically treated.. WARNING: Never point the beam of light on the eyes. The effect of the light should be limited to that part of the oral cavity to be clinically treated. WARNING: Contraindications. Do not use this equipment for patients who have a case history of positive reaction to stimulation by light, e.g. urticaria solaris and/or porphyria, etc. or who are receiving treatment with photosensitising drugs. In all cases of possible risk consult a specialised physician. WARNING: Contraindications. Adopt strict safety measures for patients who have undergone cataract surgery and who are therefore particularly sensitive to light (e.g. protective goggles able to filter out blue light). WARNING: Contraindications. Patients who have a case history of diseases of the retina should consult their optician beforehand and be specifically authorised to receive treatment with the starlight s x5.

4

Introduction CAUTION: Photobiological safety of the curing lights and lamp systems IEC 62471. According to the Standard IEC 62471, the device results in risk class 2 (moderate risk) concerning a retinal risk from blue light or thermal retinal risk. The following CAUTION indications are applied to the device package.

Risk Group 2 CAUTION. Possibly hazardous optical radiation emitted from this product. Do not stare at operating lamp. May be harmful to the eye Product tested against IEC62471

Figure 1 – Photobiological safety WARNING: Cleaning, disinfection and sterilisation of new or repaired products. Before treatment, all new or repaired products should be cleaned and disinfected and, if suitable for this treatment, autoclave sterilised following the instructions provided in Chapter 5 on page 11 strictly. WARNING: Infection control. In order to ensure maximum safety for both the patient and the operator, clean, disinfect and sterilise the optical fibre and the optical protection before each treatment. Follow the instructions provided in Chapter 5 on page 11. WARNING: Use only original Mectron accessories and spare parts. WARNING: Checking the condition of the device before treatment. Before each treatment always check that the equipment is in proper working order and that the accessories are efficient. Do not carry out the treatment if any problems are encountered in operating the equipment. If the problems concern the equipment contact an authorised technical service centre. WARNING: Risk of explosions. The equipment cannot operate in environments where there are saturated atmospheres of flammable gases (anaesthetic mixtures, oxygen, etc.). CAUTION: In case the final user, operating in their own medical room or surgery, in order to comply with mandatory requirements, must periodically inspect the equipment present in the surgery, the test procedures to apply to medical electrical equipment and medical electrical systems for the safety assessment must be carried out following the standard EN 62353 ‘Medical electrical equipment - Periodic inspections and tests to be carried out after repair of medical electrical equipment’. The interval for periodic checks, in the intended operating conditions and described in this “Use and Maintenance” manual, is one year or 2000 hours of use, depending on which of these two conditions occurs first.

5

starlight s x5 WARNING: If an adverse event and/or serious incident 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.

2

IDENTIFICATION DATA

A correct description of the model and of the serial number of the device will allow the After Sales Service to provide fast and effective answers. Always provide this information every time that you contact MECTRON After Sales Service.

2.1

Identification Data of the Handpiece

On the handpiece are reported some symbols (see Chapter 7 on page 14) and the serial number (see Figure 2 at page 6 - Ref. A).

03120143

056000000

Data Matrix HIBC 128

starlight s x5

YYYY-MM

A

Figure 2 – Identification Data of the Handpiece

6

Delivery

3

DELIVERY

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 the 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.

3.1

List of Components

Refer to Figure 3 at page 7: A.

1 starlight s x5 handpiece;

C.

1 Optical protection.

B.

1 Optical fibre;

These components can also be ordered separately. NOTE: The components included in the package may vary in occasion of promotional campaigns.

C

B

A

Figure 3 – List of Components

7

starlight s x5

4

USE

4.1

Connecting the Accessories

 WARNING: Check the condition of the device before the treatment. Before each treatment, always make sure that the equipment is working properly and check the efficiency of the accessories. If any improper functioning is noted, do not proceed with the treatment. If the problem concerns the equipment contact an authorised technical assistance centre.  WARNING: Infections control. For maximum safety of the patient and of the operator, before each treatment, clean, disinfect and sterilise the optical fibre and the optical protection. Carefully follow the instructions provided in Chapter 5 on page 11.

Before using the starlight s x5 proceed as follows (see Figure 4 at page 8): 1. 2. 3.

Manually insert the optic fibre onto the handpiece, applying gentle pressure. If necessary, rotate until it clicks into place; Fit the optical protection onto the optical fibre by hand.

Correctly insert starlight s x5 onto the cord, checking that the electrical contacts of both parts are completely dry. Dry with an air syringe if necessary.

1

2

3

Figure 4 – Connecting the Accessories

8

Use 4.2

Descriptions of Commands and Signalling

For the description of commands and signalling, refer to Figure 5 at page 9, Table 1 at page 9 and to the Table 2 at page 9.

A

Figure 5 – Handpiece push button Ref.

Symbol

Description Push-button for activating and cutting off the emission of light.

A Table 1 – Commands description Function/Event

Command

Signalling

FAST polymerisation

Push button pressed for a short time

1 beep when the light emission starts. 1 beep on completion of the 10 sec exposure.

SLOW RISE polymerisation

Push button keep pressed for at least 2 sec.

1 beep when the light emission starts and 1 beep after 2 sec. 1 beep after 10 sec. of exposure. 1 beep on completion of the 20 sec exposure.

Interruption of exposure cycle

Push button pressed for a short time during the exposure

1 beep

Thermal protection intervention indication

3 beep during the polymerisation cycle and interruption of the cycle.

Table 2 – Signalling

9

starlight s x5 4.3

Safety Requirements During Use

 WARNING: Never point the beam of light in the direction of the eyes.  WARNING: Before each cycle of exposure make sure that the optical fibre is correctly and fully fitted into the handpiece.  WARNING: Before each cycle of exposure always make sure that the optical protection has been fitted onto the end of the optical fibre.  WARNING: Point the beam of light directly onto the material to be polymerised. Do not subject the gum or other soft tissues to the beam of light (shield these parts suitably if necessary). The effect of the light should be limited to the oral cavity and in particular to the sector requiring clinical treatment..

CAUTION: During the first few seconds of exposure avoid contact of the tip with the material to be polymerised. Deposits of composite material adhering to and polymerised to the tip terminal surface lower the amount of light transmitted and will therefore prejudice subsequent polymerisation operations. CAUTION: If the optical fibre is damaged or not efficient, this will reduce the intensity of the light being emitted considerably. In such cases it should therefore be replaced.  WARNING: During the intervention on the patient, do not perform any maintenance tasks on the system.

4.4

Instructions for Use

starlight s x5 allows performing 3 types of exposures: • •

FAST : exposure time of 10 seconds at the maximum light intensity;

SLOW RISE: exposure time 20 seconds with a gradual increase of the light intensity during the first 3 seconds up to the maximum intensity.

NOTE: Refer to Chapter 4.2 on page 9 for the descriptions of commands. Selecting the FAST exposure: 1. 2.

Press the push button on the handpiece (Table 1 at page 9 - Ref. A) for a short time to start the cycle. An acoustic signal will be emitted (1 beep). After 10 seconds, an acoustic signal will be produced (1 beep). The cycle has been completed.

Selecting the SLOW RISE exposure: 1. 2. 3.

10

Keep pressed the push button on the handpiece (Table 1 at page 9 - Ref. A) for 2 seconds. An acoustic signal is emitted when the cycle starts and after 2 seconds. After 10 seconds an acoustic signal will be emitted (1 beep).

After 20 seconds an acoustic signal will be emitted (1 beep). The cycle has been completed.

Cleaning, Disinfection and Sterilisation NOTE: Cycle interruption. In all modes, the exposure cycle can be interrupted at any time by pressing the button on the handpiece (Table 1 at page 9 - Ref. A). NOTE: Additional exposures. At the end of any exposure cycle, it is possible to carry out one or more additional cycles by pressing the button on the handpiece again each time (Table 1 at page 9 - Ref. A).

4.5

Safety Protection

In the event of extremely heady duty use, with long and repeated exposure cycles, a thermal protection device is triggered automatically. An acoustic signal (3 beeps) will be emitted. This protection device will temporarily prevent use of the lamp for a few minutes.

5

CLEANING, DISINFECTION AND STERILISATION

5.1

Cleaning and Disinfecting the Handpiece

 WARNING: The handpiece is not protected against the entry of liquids.  WARNING: The handpiece should not be sterilised.  WARNING: Do not spray liquids directly onto its surface and onto the electrical contacts of the charging unit.

After each treatment, proceed as follows: 1. 2.

Remove the optical fibre and the optical protection from the handpiece;

Clean and disinfect the handpiece surface using a cloth dampened with a nonaggressive, pH-neutral (pH7) detergent/disinfectant solution. Carefully follow the instructions given by the manufacturer of the disinfectant solution. Allow the disinfectant solution to air dry prior to using the handpiece. Above all, ensure that electrical contacts are properly dry.

CAUTION: Water-based disinfectants with a neutral pH are strongly recommended. Some alcohol based disinfectant solutions may be harmful and cause damage to plastic materials. Do not use as disinfecting agents: •

Very alkaline products (pH > 9);

•

Products containing hydrogen peroxide;

• • • •

Products containing sodium hypochlorite; Products containing abrasive substances; Acetone;

Methylethylketone.

as they can discolour and/or damage the plastic materials.

11

starlight s x5 5.2

Sterilisation Procedure

 WARNING: Once clearing operations have been completed, before sterilisation check all objects under a suitable light source. Pay particular attention to parts that may hide residue dirt (threading, cavities, channelling). If necessary, repeat the cleaning cycle.

CAUTION: Carry out sterilisation only in a steam autoclave at a maximum temperature of 135° for 20 minutes. Do not use any other sterilisation procedures (dry heat, radiation, ethylene oxide, gas, low-temperature plasma, etc.).  WARNING: The handpiece should not be sterilised.  WARNING: Infections control - Sterilisable parts. To avoid infection caused by bacteria or viruses, always clean the following components after each treatment:

• •

Optical fibre;

Optical protection.

These components are made of materials able to withstand a maximum temperature of 135 °C for a maximum of 20 minutes. The sterilization process, in a steam autoclave, guarantees SAL 10-6 by setting the parameters indicated below: •

Type of cycle: 3 times Pre-vacum (pressure min. 60 mBar).

•

Minimum sterilisation time: 4 minutes.

• •

Minimum sterilisation temperature: 132 °C (interval 0 °C ÷ +3 °C). Minimum drying time: 20 minutes.

All stages of sterilisation must be performed by the operator in compliance with the current revision standards: UNI EN ISO 17665-1, UNI EN ISO 556-1 and ANSI/AAMI ST:46.

12

Disposal Procedures and Precautions 5.3

Cleaning, Disinfection e Sterilisation of the Optical Fibre

CAUTION: Do not use sharp-edged objects to clean the optical fibre. Carry out the following operations: 1.

Eliminate any residues of polymerised composites from the surface of the optical fibre with alcohol.

2.

Disinfect the surface using a cloth moistened with a solution of mild detergent/ disinfectant having a neutral pH (pH 7).

3.

Dry.

4.

Seal the optical fibre in a disposable bag on its own.

5.

Autoclave sterilise the optical fibre.

5.4

Cleaning, Disinfection e Sterilisation of the Optical Protection

CAUTION: Do not use sharp-edged objects to clean the optical protection. Carry out the following operations: 1. 2. 3. 4.

6

Clean and disinfect the surface using a cloth moistened with a solution of mild detergent/ disinfectant having a neutral pH (pH 7). Dry.

Seal the optical protection in a disposable bag on its own. Autoclave sterilise the optical protection.

DISPOSAL PROCEDURES AND PRECAUTIONS

•

This equipment must be disposed of and treated as waste requiring separate collection;

•

Failure to comply with the foregoing points may entail punishment in accordance with Directive about waste of electrical and electronic equipment WEEE.

•

At the end of the life-cycle of this equipment, the purchaser is entitled to return the equipment to the dealer supplying new equipment. Instructions for disposal are available from Mectron S.p.A.;

 WARNING: Hospital waste. Treat the following items as hospital waste:

• •

Optical fibre, when worn or broken;

Optical protection, when worn or broken.

13

starlight s x5

7

SYMBOLS Symbol

Description Device compliant with EU MDR  Regulation 2017/745.

Symbol

Medical Device

CAUTION, See instructions for use.

Consult instructions for use

Manufacturer

Date of manufacture

Serial number

Lot Number

Product Number

Non sterile

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

Type “BF” applied part in conformity with technical norm IEC/EN 60601-1

Starts or stops a polymerisation cycle

Direct current

Alternate current

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

Temperature limitation - transport and storage conditions

Humidity limitation transport and storage conditions

Atmospheric pressure limitation - transport and storage conditions

General warning a)

Table 3 – Symbols a) The symbol is represented by a yellow warning triangle and a black graphical symbol.

14

Description