mectron starlight s + User manual
INSTALLATION MANUAL
starlight s +
STARLIGHT S +
I
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.
Disclaimer
does not guarantees the completeness of the contents in this document and consequently
cannot assume any responsibility for any error or damages of any kind arising out of or in any
way connected to the information issued on the product and on the use of the same.
It is understood that it is the responsibility of the user to control the updates that Mectron S.p.A.
will make available in a special section of its website.
II
STARLIGHT S +
SUMMARY
1 Introduction 1
1.1 Intended Use 2
1.2 Description of the Device 2
1.2.1 Patient Group Directions 2
1.2.2 Patient Selection Criteria 2
1.2.3 Indications for Use 3
1.2.4 Users 3
1.3 Disclaimer 3
1.4 Safety Requirements 4
2 IdenticationData 6
3 Delivery 7
3.1 List of Components 7
4 Installation 8
4.1 Safety Requirements in the Installation Phase 8
4.2 Device Connection 9
4.3 Descriptions of Commands and Signalling 10
5 Disposal Procedures and Precautions 11
6 Symbols 12
7 Troubleshooting 13
7.1 Quick Troubleshooting Guide 13
7.2 Diagnostic System and Possible Solutions 14
7.3 How to Prepare the Device and the Accessories Before Sending them to Repair 14
8 TechnicalSpecications 15
8.1.2 Accessible Parts of the Casing 17
8.1.3.1 Power Connection A.C. Input 18
8.1.3.2 Points of Contact with the Patient 20
8.1.3.3 Parts Accessible to the Input / Output Signals 21
Casing to the Wireless RF Communications Device 22
9 Warranty 23
III
IV
STARLIGHT S +
PAGE INTENTIONALLY LEFT BLANK
1
INTRODUCTION
1 INTRODUCTION
other intervention operations on the device.
Always keep this manual at hand.
Important
paragraphs “Safety Requirements” present in the manual.
indications:
WARNING: (Always referred to damage to persons)
CAUTION: (Referring to possible damages to things)
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 s
ection MANUALS of MECTRON website
1;
•
• contact MECTRON After Sales Service.
2
STARLIGHT S +
1.1 Intended Use
in the wavelength band comprised between 440 and 480 nm.
1.2 Description of the Device
starlight s +
is used to
activate the camphorquinone photoinitiator.
1.2.1 Patient Group Directions
This medical device is designed to be used with the following patient population:
• Children;
• Adolescents;
• Adults;
• Elderly.
and nationality.
1.2.2 Patient Selection Criteria
The use of the device is not recommended in the following cases:
1.
and/or other electromagnetic prostheses) without the prior authorization of their doctor;
2.
3.
ophthalmologist to receive authorization for treatment with the Mectron curing light.
WARNING: Adopt strict safety measures for patients who have undergone cataract surgery
light).
person able to decide if and how to treat their patients.
WARNING: Contraindications.
consulted.
3
INTRODUCTION
1.2.3 Indications for Use
The use of the device is indicated for all the intended patients (see
Chapter 1.2.1 on page
2
Chapter 1.1 on page 2
).
1.2.4 Users
1.3 Disclaimer
of incorrect procedures linked to the use of the device and its accessories.
•
the product;
• The environmental conditions for preservation and storage of the device are not
complying with the requirements indicated in
Chapter 8 on page
;
• 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;
•
carried out by personnel not authorized by MECTRON;
•
treatment and/or incorrect interventions;
•
• Breach of the requirements and the information contained in
10
of
the Use and Maintenance manual;
• Unauthorized repairs in accordance with the indications contained in
Chapter 9 on page
23
of this manual.
4
STARLIGHT S +
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: Qualiedandspecialisedpersonnel.
training activities are foreseen for the use of the device. The use of the device does not cause
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: Pointthebeamoflightdirectlyatthematerialtobepolymerised.
Do not point the beam of light on the gums or other soft tissues (if necessary these parts
cavity to be clinically treated..
WARNING: Neverpointthebeamoflightontheeyes.
WARNING: Contraindications.
Do not use this equipment for patients who have a case history of positive reaction to
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
WARNING: Contraindications.
Patients who have a case history of diseases of the retina should consult their optician
.
CAUTION: PhotobiologicalsafetyofthecuringlightsandlampsystemsIEC62471.
concerning a retinal risk from blue light or thermal retinal risk.
The following CAUTION indications are applied to the device package.
INTRODUCTION
Risk Group 2
CAUTION. Possibly hazardous optical
radiation emitted from this product.
Do not stare at operating lamp. May
be harmful tothe eye
Product tested against IEC62471
Figure 1 – Photobiological safety
WARNING: Cleaning, disinfection and sterilisation of new or repaired products.
on page 10
of the Use and Maintenance manual strictly.
WARNING: Infection control.
instructions provided in
10
of the Use and Maintenance manual.
WARNING: Use only original Mectron accessories and spare parts.
WARNING: Checkingtheconditionofthedevicebeforetreatment.
Before each treatment always check that the equipment is in proper working order and that
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
CAUTION:
electrical systems for the safety assessment must be carried out following the standard EN
WARNING: If an adverse event and/or serious incident attributable to the device occurs
and to the manufacturer indicated on the product label.
STARLIGHT S +
2 IDENTIFICATION DATA
A correct description of the model and of the serial number of the device will allow the After
Always provide this information every time that you contact MECTRON After Sales Service.
2.1 IdenticationDataoftheHandpiece
and a series of symbols (see ).
NOTE: The complete list of symbols is shown in
12
.
ES 60601-1
326000000
yyyy
IP44
starlight s+
Data Matrix HIBC 128
Figure 2 –
7
3 DELIVERY
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.
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 + handpiece;
B.
C. 1 Optical protection;
D. Cord and connector.
These components can also be ordered separately.
NOTE: The components included in the package may vary in occasion of promotional
campaigns.
A
B D
C
Figure 3 – List of Components
8
STARLIGHT S +
4 INSTALLATION
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
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.
CAUTION:
WARNING: The device electricity supply voltage must comply with the plate characteristics.
CAUTION:
9
INSTALLATION
4.2 Device Connection
The device shall be installed on a dental chair. We recommend to apply the wiring scheme as
shown in Figure 4 at page 9
protecting the line by a fuse.
fuse
T 315 mAL
250 V
tool-holder
Starlight s + Cord
Clamps
Black
Red White
Fusebox, fuse, tool-holder
and clamps are not provided
by Mectron
Power Supply
24 V~ 50/60 Hz
o 32 V
Tearing-resistant
line
Figure 4 – Device connection
NOTE: The device is not equipped with a disconnection device from the power network
and the manufacturer of the dental chair shall take care of assuring the compliance to this
requirement.
10
STARLIGHT S +
4.3 Descriptions of Commands and Signalling
Table 1 at page 10.
Ref. Name Description
A
B
C
AStart button Starts or stops a
polymerisation cycle.
BMode
button
type. By repeatedly pressing
selected:
SOFT
CGreen Mode
LED
Indicates the selected
Table1 – Descriptions of Commands and Signalling
Selected function
viaModebutton Signalling Exposure Type Exposure Time
FAST Polymerisation Left LED ON
emitted.
10 sec.
20 sec.
SLOW RISE
Polymerisation Middle LED ON
Increased emission
emission power
10 sec.
20 sec.
SOFT Polymerisation Right LED ON
Emission 70% of
whole cycle
10 sec.
20 sec.
Table2 – Mode signalling.
11
DISPOSAL PROCEDURES AND PRECAUTIONS
5 DISPOSAL PROCEDURES AND
PRECAUTIONS
CAUTION: ThisdevicecontainsaLITHIUM-IONbattery. The battery must be disposed
of and treated as waste requiring separate collection;
• This equipment must be disposed of and treated as waste requiring separate collection;
•
equipment to the dealer supplying new equipment. Instructions for disposal are available
from Mectron S.p.A.;
• Failure to comply with the foregoing points may entail punishment in accordance with
Directive about waste of electrical and electronic equipment WEEE.
WARNING:Hospitalwaste.
Treat the following items as hospital waste:
•
•
12
STARLIGHT S +
6 SYMBOLS
Symbol Description Symbol Description
Device compliant with
Regulation EU MDR
Nemko Mark
compliance
Medical Device
instructions for use.
Consult instructions
for use Manufacturer
YYYY
manufacture included
Date of manufacture
Serial number Lot Number
Product Number Non sterile
Can be sterilised in
autoclave up to a
Type “B” applied part
in conformity with
technical norm IEC/EN
Direct current Alternate current
Starts or stops a
polymerisation cycle
The device and its
accessories must not be
disposed of or treated
as solid urban waste
Temperature limitation
conditions
transport and storage
conditions
Atmospheric pressure
and storage conditions
General warning a)
IP 44
Protection degree
provided by the casing
Table3 – Symbols
a) The symbol is represented by a yellow warning triangle and a black graphical symbol.
13
TROUBLESHOOTING
7 TROUBLESHOOTING
7.1 QuickTroubleshootingGuide
the Table 4 at page 13.
Problem PossibleCause Solution
An acoustic signal (3 beeps)
is produced during the
end of the cycle starlight s +
will not allow any further
treatment to be carried out.
The selected function LED
The thermal protection has
been activated.
It will be possible to use
the equipment only after
it has cooled down. Wait
warning sounds (4 beeps)
and the device does not
emit light.
The temperature control
circuit reports a failure.
Contact a Mectron service
centre.
the intensity of the light
emitted is unsuitable.
The control circuit reports an
LED failure.
Contact a Mectron service
centre.
The polymerisation is
The terminal surface of the
soiled.
See
10
of
the Use and Maintenance
manual
.
Table4 – Quick Troubleshooting Guide
14
STARLIGHT S +
7.2 DiagnosticSystemandPossibleSolutions
The device is provided with a diagnostic circuit that allows identifying the main operating issues.
Signalling Type Description Solution
4 Beep
The temperature control
circuit is failed.
The device does not emit
any light.
Contact a Mectron service
centre.
3 Beep
The control circuit indicates
temperature has been
reached.
The device does not emit
any light.
Place the device back in
its housing and wait about
10 minutes before using it
again.
The control circuit reports an
LED failure.
The device does not emit any
emitted light is very low.
Contact a Mectron service
centre.
Table5 – Diagnostic System and Possible Solutions
7.3 HowtoPreparetheDeviceandtheAccessories
Before Sending them to Repair
conduct reported in the following:
1.
10 of
the Use and Maintenance manual;
2. Sterilse the sterilisable parts according to the instructions reported in the
page 10 of
the Use and Maintenance manual:
•
• Optical protection.
3. Leave the sterilised parts in their sterilization pouches that certify the sterilization
completion;
4.
The above requirements (points 1 and 2) are in compliance with the current requirements
81/08 and subsequent amendments.
reserves the right to charge him/her for cleaning and sterilization costs or to reject the items for
repair received in unsuitable conditions.
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