mectron Starlight Pro User manual

USE AND MAINTENANCE MANUAL
starlight pro

starlight pro

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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.

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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
3.1 List of Components 8
4.1 Safety Requirements in the Installation Phase 9
4.2 Connecting the Accessories 10
4.3 Descriptions of Commands and Signalling 11
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
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

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Casing to the Wireless RF Communications Device 33

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starlight pro

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1 https://manuals.mectron.com/
other intervention operations on the device.
Always keep this manual at hand.
paragraphs “Safety Requirements” present in the manual.
indications:
(Always referred to damage to persons)
(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;
•
•

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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
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 - (cycle lasting 10 seconds);
• Gradual intensity of emission - (cycle lasting 20 seconds).
1.2.1
This medical device is designed to be used with the following patient population:
• Children;
• Adolescents;
• Adults;
• Elderly.
and nationality.
1.2.2
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.
Adopt strict safety measures for patients who have undergone cataract surgery
light).

3
person able to decide if and how to treat their patients.
consulted.
1.2.3
The use of the device is indicated for all the intended patients (see
).
1.2.4 Users
1.3
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 ;
• 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
this manual;
• Unauthorized repairs in accordance with the indications contained in
of this manual.

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starlight pro
1.4
No alterations to this device are permitted.
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.
training activities are foreseen for the use of the device. The use of the device does not cause
Intended use.
Use the equipment solely for the purpose for which it is intended (see
). 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.
Do not use the device on patients with Pacemakers or other implantable electronic devices.
This regulation also applies to the operator.
Do not point the beam of light on the gums or other soft tissues (if necessary these parts
cavity to be clinically treated..
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.
Adopt strict safety measures for patients who have undergone cataract surgery and who are
Patients who have a case history of diseases of the retina should consult their optician
concerning a retinal risk from blue light or thermal retinal risk.

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Risk Group 2
CAUTION. Possibly hazardous optical
radia tion emi tte d from this product.
Do not stare at operating lamp. May
be harmf ul to the eye
Product tested against IEC62471
Photobiological safety
strictly.
instructions provided in .
Use only original Mectron accessories and spare parts.
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.
The equipment cannot operate in environments where there are saturated atmospheres of
Do not use the charging unit to recharge other types of batteries or other
equipment with rechargeable batteries.
Recharge the battery only with the Mectron charging unit (
- Ref. A). Do not attempt to recharge the battery using a generic battery charger. This

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starlight pro
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
If an adverse event and/or serious incident attributable to the device occurs
and to the manufacturer indicated on the product label.

2
A correct description of the model and of the serial number of the device will allow the After
2.1
placed to the underside of the equipment. The complete technical data are reported in
.
The complete list of symbols is reported in Chapter 9 on page 23.
2.2
) and the serial
The complete list of symbols is reported in Chapter 9 on page 23.
Data Matrix HIBC 128
SN
YYYY-MM
starlight pro
000000000
03120000

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starlight pro
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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
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.
The content may vary during promotional campaigns.
A
B E
C
D
List of Components

9
4
The device must be installed in a suitable place that is convenient for its use.
The place where the device is installed must meet the requirements found in
the .
4.1
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.
The device cannot operate in environments where there are
Install the device in a safe place protected from impact or accidental water or
liquid spray.
Do not install the device above or near sources of heat. Arrange during
installation for a suitable circulation of air around the device.
the charging unit (Figure 5 at page 10 - Ref. B) when the device is on.
The device can be transported but must be handled with care when moved.
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.

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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
Charging unit.
Make sure that the voltage and frequency of the power-supply line match the
replace it with an original Mectron spare part.
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.

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4.3
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
Dbutton
Starts or stops a
polymerisation cycle.
Descriptions of Commands and Signalling
Action/Button
FAST
polymerisation
button pressed for a
short time
when the light
emission starts.
on completion of
button pressed for at
least 2 sec
when the light
emission starts and 1 beep
after 2 sec.
after 10 sec. of
on completion of
cycle
button pressed for
a short time during the

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starlight pro
Action/Button
Low battery indication. The
remaining battery charge is
of 6 cycles.
on completion of
Battery discharged
indication.
button pressed
polymerisation
- No light emission.
Thermal protection
intervention indication
on completion of
the polymerisation cycle
and interruption of the
cycle.
Description of the acoustic signals of the handpiece.
unit
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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BATTERY
unit
Not inserted
Light emission
suitable for
treatment.
Description of light signals on the charging unit.
5
starlight pro is powered by a rechargeable lithium-ion battery already contained inside the
starlight pro is equipped with two microprocessors that check the battery continuously and
maintain the optimum battery charging parameters. The handpiece may therefore be placed
of the battery.
5.1
The battery of the starlight pro is provided partially charged.
To charge completely the battery:
1. Place the handpiece into its housing in the charging unit (Figure 5 at page 10 - Ref. B).
The green battery LED will light up (Table 1 at page 11 - Ref. B).
2.
5.2
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.
).
Place the starlight pro handpiece back into the charging unit.
5.3
and at the same time an acoustic signal is produced (2 beeps). Recharge the battery:

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starlight pro
1. Place the handpiece into its housing in the charging unit (Figure 5 at page 10 - Ref. B).
The green battery LED will light up (Table 1 at page 11- Ref. B).
2.
5.4
means that there is a fault with the battery.
This failure condition disables operation of the charging unit. To restore proper working
conditions proceed as follows:
1. Remove the handpiece from the charging unit;
2.
3. Reconnect the cable of the charging unit. The green power LED will light up.
5.5
5.6
The battery can cause damage to property and/or personal injuries such as burns if conducting
terminals.
The conducting material could close an electrical circuit (short circuit) and become very hot.
other container in which there are metal objects.
stops and it is necessary to reposition it on the battery charger to resume its operation.
(Figure 6 at page 14 - Ref. A Ref. B).
A
B
Electric contacts of the handpiece.