mectron Starlight Pro User manual
USE AND MAINTENANCE MANUAL
GEBRAUCHS- UND WARTUNGSANLEITUNG
MANUALE D’USO E MANUTENZIONE
MODE D’EMPLOI ET D’ENTRETIEN
MANUAL DE USO Y MANTENIMIENTO
starlight pro
USE AND MAINTENANCE MANUAL
starlight pro
starlight pro
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.
II
starlight pro
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 7
3 Delivery 8
3.1 List of Components 8
4 Installation 9
4.1 Safety Requirements in the Installation Phase 9
4.2 Connecting the Accessories 10
4.3 Descriptions of Commands and Signalling 11
5 Battery 13
5.1 New Battery - First Charging 13
5.2 Low Battery Indication 13
5.3 Battery Discharged Indication 13
5.4 Battery Failure Indication 14
5.5 Battery Replacement 14
5.6 Battery Safety Requirements 14
6 Use 16
6.1 Connecting the Accessories 16
6.2 Safety Requirements During Use 16
6.4 Light Intensity Measurement 18
6.5 Safety Protection 19
6.6 Yellow Battery LED on the Charging Unit 19
7 Cleaning,DisinfectionandSterilisation 19
8 DisposalProceduresandPrecautions 22
9 Symbols 23
10 Troubleshooting 24
11 TechnicalSpecications 25
11.1.2 Accessible Parts of the Casing 28
11.1.3 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity 29
11.1.3.1 Power Connection A.C. Input 29
11.1.3.2 Points of Contact with the Patient 31
III
Casing to the Wireless RF Communications Device 33
12 Warranty 35
IV
starlight pro
PAGEINTENTIONALLYLEFTBLANK
1
1 INTRODUCTION
1 https://manuals.mectron.com/
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.
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
1;
•
•
2
starlight pro
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.
This equipment may be used only in a dentist’s surgery or out-patient’s department where there
1.2 DescriptionoftheDevice
starlight pro is an equipment for polymerising photo-hardening composites.
between 440 nm
and 465 nm.
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.
starlight pro can be used to operate in either of two emission modes:
• Constant intensity of emission - FAST (cycle lasting 10 seconds);
• Gradual intensity of emission - SLOWRISE (cycle lasting 20 seconds).
1.2.1 PatientGroupDirections
This medical device is designed to be used with the following patient population:
• Children;
• Adolescents;
• Adults;
• Elderly.
and nationality.
1.2.2 PatientSelectionCriteria
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).
3
person able to decide if and how to treat their patients.
WARNING:Contraindications.
consulted.
1.2.3 IndicationsforUse
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 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;
•
•
treatment and/or incorrect interventions;
•
• Breach of the requirements and the information contained in
19 of
this manual;
• Unauthorized repairs in accordance with the indications contained in
Chapter 12 on page
35
of this manual.
4
starlight pro
1.4 SafetyRequirements
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.
5
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
Figure1 – Photobiological safety
WARNING: Cleaning,disinfectionandsterilisationofneworrepairedproducts.
on page 19
strictly.
WARNING:Infectioncontrol.
instructions provided in
19
.
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: Riskofexplosions.
The equipment cannot operate in environments where there are saturated atmospheres of
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 4 at page
8
- Ref. A). Do not attempt to recharge the battery using a generic battery charger. This
6
starlight pro
CAUTION:
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
WARNING: If an adverse event and/or serious incident attributable to the device occurs
and to the manufacturer indicated on the product label.
2 IDENTIFICATIONDATA
A correct description of the model and of the serial number of the device will allow the After
2.1 IdenticationLabeloftheChargingUnit
) on which
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.
Data Matrix HIBC 128
manufacturer
Mectron S.p.A.
via Loreto 15/a
Carasco -GE- Italy
YY000000 made in Italy
starlight pro
-CHARGER-
100-230 V~ 50/60 Hz 15 VA
00000000
YYYY-MM
Figure2 –
2.2 IdenticationDataoftheHandpiece
Chapter 9 on page 23
) and the serial
number (see ).
NOTE: The complete list of symbols is reported in Chapter 9 on page 23.
Data Matrix HIBC 128
SN
YYYY-MM
starlight pro
000000000
03120000
Figure3 –
8
starlight pro
3 DELIVERY
therefore the transport and the storage must be carried out with particular care.
The device is shipped appropriately protected and packaged.
Service Centre and to store the device during long periods of inactivity.
3.1 ListofComponents
Refer to Figure 4 at page 8:
A. 1 starlight pro charging unit;
B. 1 starlight pro handpiece with rechargeable lithium-ion battery;
C.
D.
E. 1 Power supply cable for the charging unit.
These components can also be ordered separately.
NOTE:The content may vary during promotional campaigns.
A
B E
C
D
Figure4 – List of Components
9
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 SafetyRequirementsintheInstallationPhase
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: Riskofexplosion. 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.
WARNING:
the charging unit (Figure 5 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:
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
starlight pro
4.2 Connecting the Accessories
In order to make the equipment operational it is necessary to proceed as follows:
1.
2. Plug the power cable (Figure 4 at page 8 - Ref. F) into the connector on the back side
of the charging unit (Figure 5 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).
A
B
Figure5 – Charging unit.
CAUTION:Make sure that the voltage and frequency of the power-supply line match the
WARNING:
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.
11
4.3 DescriptionsofCommandsandSignalling
Table 1 at page 11.
Ref. Name Description
C
D
A B
APower LED
green
Indicates that the charging
unit is powered up.
B
Battery LED
green
Indicates that the battery is
being charged.
Battery LED
yellow
Indicates that the battery of
the has failed.
C
Test LED
green
Indicates that the light
intensity is suitable for
Test LED
yellow
Indicates that the light
D
button
Starts or stops a
polymerisation cycle.
Table1 – Descriptions of Commands and Signalling
Function Action/Button Acousticsignal
FAST
polymerisation
on/o button pressed for a
short time
1beep when the light
emission starts.
1beep on completion of
on/o button pressed for at
least 2 sec
1beep when the light
emission starts and 1 beep
after 2 sec.
1beep after 10 sec. of
1beep on completion of
cycle
on/o button pressed for
a short time during the
1beep
12
starlight pro
Function Action/Button Acousticsignal
Low battery indication. The
remaining battery charge is
of 6 cycles.
2beep on completion of
Battery discharged
indication.
on/o button pressed
polymerisation
2beep - No light emission.
Thermal protection
intervention indication
3beep on completion of
the polymerisation cycle
and interruption of the
cycle.
Table2 – Description of the acoustic signals of the handpiece.
PowerLED BatteryLED TestLED
Positionofthe
handpiecein
thecharging
unit
Function
Not inserted Charging unit
powered.
Inserted Battery being
recharged.
Inserted
Recharging
completed.
Battery
charged.
Inserted Battery failed.
Not inserted
Electric
contacts of the
charging unit
short-circuited.
Not inserted No light
emission.
Not inserted Low light
emission.
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