starlight Use and Maintenance Manual Rev 04

USE AND MAINTENANCE MANUAL

starlight uno

starlight uno

 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 uno SUMMARY

1

Introduction

2

Identification Data

6

3

Delivery

8

4

Installation

9

5

Battery

13

6

Use

15

7

Cleaning, Disinfection and Sterilisation

18

8 9 10 11

Disposal Procedures and Precautions Symbols Troubleshooting Technical Specifications

22 23 24 25

1.1 1.2 1.2.1 1.2.2 1.2.3 1.2.4 1.3 1.4 2.1 2.2 2.3 3.1 4.1 4.2 4.3 5.1 5.2 5.3 5.4 5.5 5.6 6.1 6.2 6.3 6.4 6.5 7.1 7.1.1 7.1.2 7.1.3 7.2 7.2.1 7.2.1.1 7.2.1.2 7.2.2 7.2.3 7.2.4 7.2.4.1

11.1

II

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

List of Components Safety Requirements in the Installation Phase Connecting the Accessories Descriptions of Commands and Signalling New Battery - First Charging Low Battery Indication Battery Discharged Indication Battery Failure Indication Battery Replacement Battery Safety Requirements Connecting the Accessories Safety Requirements During Use Instructions for Use Light Intensity Measurement Safety Protection

Cleaning and Disinfection of the Handpiece and the Charging Unit Preparation Necessary Material Cleaning Method Cleaning and Sterilisation of the Optical Protection Manual Cleaning Necessary Material Cleaning Method Cleaning Control Drying Sterilisation Sterilisation Method

Electromagnetic Compatibility IEC/EN 60601-1-2

1 2 2 2 2 3 3 3 4 6 7 7

8

9 10 11 13 13 13 14 14 14 15 16 16 17 17 18 18 19 19 20 20 20 20 21 21 21 21

26

 11.1.1 11.1.2 11.1.3 11.1.3.1 11.1.3.2 11.1.3.3 11.1.4

12

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

Warranty

26 27 28 28 30 31 32

34

III

starlight uno

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;

http://mectron.it/en/technical-support/users-manuals/

1

starlight uno 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 with a narrow peak at 460 nm. Although most composite materials are activated within this wavelength range, in case of uncertainty consult the specifications of the composite material. 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 uno is an equipment for polymerising photo-hardening composites. The light source used is a very high-efficiency monochromatic LED. Unlike traditional halogen lamps, therefore, all the light being emitted by starlight uno is used to activate the camphorquinone photoinitiator. The device consists of a charging unit with a brightness meter and a handpiece powered by a rechargeable lithium-ion battery that can be removed and replaced directly by the user. starlight uno 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. WARNING: Contraindications. In all cases of potential risk, a specialist doctor must be consulted.

2

Introduction 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 11 on page 25;

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 7 on page 18 of this manual;

Unauthorized repairs in accordance with the indications contained in Chapter 12 on page 34 of this manual.

3

starlight uno 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 uno. 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.

4

Introduction

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 7 on page 18 strictly. WARNING: Infection control. For maximum safety of the patient and of the operator, before each treatment, clean and disinfect the charging unit and the handpiece, clean and sterilise the optical protection and replace the protective sheath. Carefully follow the instructions provided Chapter 7 on page 18. 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.). WARNING: Do not use the charging unit to recharge other types of batteries or other equipment with rechargeable batteries. CAUTION: Recharge the battery only with the Mectron charging unit (Figure 5 at page 8 - Ref. A). Do not attempt to recharge the battery using a generic battery charger. This entails a risk of explosion and fire.

5

starlight uno 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. 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 Label of the Charging Unit

Each charging unit is provided with an identification label (see Figure 2 at page 6) on which the main technical specifications and the lot number are reported. The identification label is placed to the underside of the equipment. The complete technical data are reported in Chapter 11 on page 25. NOTE: The complete list of symbols is reported in Chapter 9 on page 23.

starlight uno -CHARGER100-240 V - 50/60Hz. 15 VA

~

000000000

00000000

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

YYYY - MM - DD Rx only Electrical Safety ES 60601-1

made in Italy

Data Matrix HIBC 128

Figure 2 – Identification Label of the Charging Unit

6

Identification Data 2.2

Identification Data of the Handpiece

On the handpiece are reported some symbols (see Chapter 9 on page 23) and the serial number (see Figure 3 at page 7). NOTE: The complete list of symbols is reported in Chapter 9 on page 23.

Data Matrix HIBC 128

03120228 328000000

YYYY-MM

starlight uno

Figure 3 – Identification Data of the Handpiece

2.3

Identification Data of the Battery Module

On each battery module are reported the technical specifications and the batch number (see Figure 4 at page 7). NOTE: The complete list of symbols is reported in Chapter 9 on page 23.

Figure 4 – Identification Data of the Battery Module

7

starlight uno

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 5 at page 8: A.

1 starlight uno charging unit;

C.

1 Rechargeable lithium-ion battery module;

B.

D. E. F.

1 starlight uno handpiece; 1 Optical protection;

50 Single use protective sheaths;

1 Power supply cable for the charging unit.

These components can also be ordered separately. NOTE: The content may vary during promotional campaigns.

D

B

F

C E

Figure 5 – List of Components

8

A

Installation

4

INSTALLATION

The device must be installed in a suitable place that is convenient for its use. WARNING: The place where the device is installed must meet the requirements found in the Chapter 4.1 on page 9.

4.1

Safety Requirements in the Installation Phase

 WARNING: 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: Risk of explosion. The device cannot operate in environments where there are saturated atmospheres of flammable gases (aesthetic mixtures, oxygen, etc.).  WARNING: Install the device in a safe place protected from impact or accidental water or liquid spray.  WARNING: Do not install the device above or near sources of heat. Arrange during installation for a suitable circulation of air around the device.  WARNING: Do not introduce metal objects into the handpiece housing in the charging unit (Figure 6 at page 10 - Ref. B) when the device is on.

CAUTION: The device can be transported but must be handled with care when moved. CAUTION: Do not expose the device to direct sunlight or sources of UV light. CAUTION: Place the device in such a way as to always have the power plug easily accessible as it is considered to be a disconnection device. CAUTION: The handpiece is intended for use within the patient environment whereas the charger unit is not intended for use within the patient environment. NOTA: The patient environment is defined as an area 1.5 m from the patient (as per IEC 606011, third edition).  WARNING: The operator must not come simultaneously into contact with the elements outside the patient environment (charger units and switching power supply adapter) and the patient. Do not connect other external components to the medical system.

9

starlight uno 4.2

Connecting the Accessories

In order to make the equipment operational it is necessary to proceed as follows: 1.

Place the charging unit on a flat surface;

3.

Connect the battery module to the handpiece by tightening the nut of the battery module to the handpiece as shown in Figure 7 at page 10.

2.

Plug the power cable (Figure 5 at page 8 - Ref. F) into the connector on the back side of the charging unit (Figure 6 at page 10 - Ref. A) and then into the power outlet. The green power LED should light up (Table 1 at page 11 - Ref. A).

B

A

Figure 6 – Charging unit.

Figure 7 – Battery module insertion. CAUTION: Make sure that the voltage and frequency of the power-supply line match the values indicated on the identification label under the charging unit.  WARNING: Check the condition of the power cable regularly. If it is found to be damaged, replace it with an original Mectron spare part.

CAUTION: Place the device in such a way as to always have the power plug easily accessible as it is considered to be a disconnection device.

10

Installation 4.3

Descriptions of Commands and Signalling

For the descriptions of commands and signalling, refer to Table 1 at page 11. Ref. A

B

C

D

Name

Description

Power LED green

Indicates that the charging unit is powered up.

Battery LED green

Indicates that the battery is fully charged (charging completed).

Battery LED yellow

Indicates that the battery is being charged.

Test LED green

Indicates that the light intensity is suitable for effective therapy.

Test LED yellow

Indicates that the light intensity is insufficient.

on/off button

Starts or stops a polymerisation cycle.

D

A

C

B

Table 1 – Descriptions of Commands and Signalling Function FAST polymerisation

SLOW RISE polymerisation

Action/Button

Acoustic signal

Light signal

on/off button pressed for a short time

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

Green LED steady on.

on/off button 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.

Yellow LED steady on.

11

starlight uno Function

Action/Button

Acoustic signal

Interruption of exposure cycle

on/off button pressed for a short time during the exposure

1 beep

Low battery indication. The remaining battery charge is sufficient for the execution of 6 cycles.

2 beep on completion of the exposure cycle. on/off button pressed for FAST or SLOW RISE polymerisation

Battery discharged indication.

Light signal

Thermal protection intervention indication

2 beep - No light emission.

Green and Yellow LEDs flashing.

3 beep on completion of the FAST polymerisation cycle or halfway through the SLOW RISE polymerisation cycle and interruption of the cycle.

Green and Yellow LEDs flashing.

Table 2 – Description of the acoustic and light signals of the handpiece.

Power LED

Battery LED

Test LED

Position of the handpiece in the charging unit

ON

OFF

OFF

Not inserted

Charging unit powered.

ON

Yellow ON

OFF

Inserted

Battery being recharged.

ON

Green ON

OFF

Inserted

Recharging completed. Battery charged.

ON

OFF

OFF

Not inserted

No light emission.

12

Function

Battery Power LED

Battery LED

Test LED

Position of the handpiece in the charging unit

Function

ON

OFF

Yellow ON

Not inserted

Low light emission.

Not inserted

Light emission suitable for an effective treatment.

ON

OFF

Green ON

Table 3 – Description of light signals on the charging unit.

5

BATTERY

starlight uno is powered by a rechargeable lithium-ion battery already contained inside the handpiece, with no memory effect. starlight uno is equipped with two microprocessors that check the battery continuously and maintain the optimum battery charging parameters. The handpiece may therefore be placed back into the charging unit at the end of each treatment and left there, regardless of the charge of the battery.

5.1

New Battery - First Charging

NOTE: The battery of the starlight uno is provided partially charged. To charge completely the battery: 1. 2.

5.2

Place the handpiece into its housing in the charging unit (Figure 6 at page 10 - Ref. B). The yellow battery LED will light up (Table 1 at page 11 - Ref. B). The charging phase has been completed when the battery LED turns to green.

Low Battery Indication

When the charge of the battery becomes low, after frequent use of starlight uno, the microprocessor will allow 6 more exposures to be carried out (FAST or SLOW RISE) without any need to recharge the battery. A battery low state is signalled at the end of each of these 6 cycles by means of 2 beeps. Once the 6 cycles have been completed, the handpiece enters a battery discharged state (see Chapter 5.3 on page 13). Place the starlight uno handpiece back into the charging unit.

5.3

Battery Discharged Indication

The battery of starlight uno is discharged if no light is emitted when pressing the on/off button and at the same time an acoustic signal is produced (2 beeps). Recharge the battery: 1.

Place the handpiece into its housing in the charging unit (Figure 6 at page 10 - Ref. B). The yellow battery LED will light up (Table 1 at page 11- Ref. B).

13