mectron STARLIGHT UNO User manual

Û Use and maintenance manual
02150343 Manuale d‘uso e man. starlight uno Rev. 02 del 11-05-2017
Reseller - Rivenditore - Wiederverkäufer - Revendeur - Revendedor
manufacturer:
Mectron S.p.A.
Via Loreto 15/A
16042 Carasco (Ge) Italy
Tel. [phone]
Fax [phone]
www.mectron.com
e-mail: [email protected] STARLIGHT UNO
STARLIGHT UNO
EN

32 starlight uno - manual of use and maintenance
00.0 Introduction......................................................................................................................33
00.1 Foreword ................................................................................................................33
00.2 Description of the equipment..................................................................................33
00.3 Intended use...........................................................................................................34
00.4 Safety requirements ...............................................................................................34
01.0 Identication data ............................................................................................................36
01.1 Identication data ...................................................................................................36
01.2 Identication plate of the charging unit...................................................................36
01.3 Identication data of the starlight uno handpiece.................................................36
01.4 starlight uno battery module identication data ...............................................37
02.0 Testing.............................................................................................................................37
02.1 Testing of the equipment ........................................................................................37
03.0 Delivery............................................................................................................................37
03.1 Delivery of the equipment.......................................................................................37
03.2 List of material included in the standard supply......................................................38
04.0 Installation .......................................................................................................................39
04.1 Safety requirements at the time of installation........................................................39
04.2 Connecting the equipment......................................................................................40
04.3 Description of the controls and signalling lamps ....................................................41
05.0 Battery .............................................................................................................................42
05.1 New battery - rst charging.....................................................................................42
05.2 Battery low signal ...................................................................................................42
05.3 Battery dead signal.................................................................................................42
05.4 Battery failed signal ................................................................................................43
05.5 Replacing the battery..............................................................................................43
05.6 Safety requirements relating to the battery.............................................................43
06.0 Use..................................................................................................................................44
06.1 Connecting the accessories ...................................................................................44
06.2 Safety requirements during use..............................................................................45
06.3 Instructions for use.................................................................................................45
06.4 Measuring the light intensity...................................................................................46
06.5 Safety protection.....................................................................................................46
07.0 Cleaning, disinfection and sterilisation ............................................................................47
07.1 Cleaning and disinfection of the handpiece and the charging unit.........................47
07.2 Cleaning and sterilisation of the optical protection.................................................48
07.2.1 Manual cleaning ............................................................................................ 48
07.2.2 Check cleaning.............................................................................................. 49
07.2.3 Drying .......................................................................................................... 49
07.2.4 Sterilisation................................................................................................... 49
08.0 Disposal procedures and precautions.............................................................................50
09.0 Symbols...........................................................................................................................51
10.0 Problem-solving ..............................................................................................................52
11.0 Technical specications ...................................................................................................53
11.1 Electromagnetic compatibility IEC/EN 60601-1-2...................................................54
12.0 Warranty ..........................................................................................................................60
Summary

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00.0 Introduction
00.1 Foreword
Before proceeding with the installation, use, maintenance or any other activities on the
equipment please read this manual carefully.
Always keep this manual within easy reach.
Important: To avoid causing personal injuries or damage to property, read all the points concerning
“Safety requirements” contained in this manual with particular attention.
Depending on the level of risk involved, safety requirements are classed under the following
indications:

WARNING (always referred to personal injury)

CAUTION (referred to possible damage to property)
The purpose of this manual is to ensure that operators are aware of the safety requirements, of the
installation procedures and of the instructions for correct use and maintenance of the equipment.
The user is not authorised to tamper with the equipment under any circumstances.
If any problems are encountered, please contact a Mectron Service Centre.
Any attempts on the part of the user or any unauthorised personnel to tamper with or alter the
equipment will invalidate the warranty and release the Manufacturers from any liability in respect of
any harm or damage to persons or property.
The information and illustrations contained in this manual are updated as of the date of publication
indicated on the last page.
MECTRON are committed to continuous up-dating of their products, which may entail changes to
components of the equipment. If there are any discrepancies between the descriptions contained
in this manual and your equipment, please contact your dealer or the MECTRON After-Sale service
for explanations.
Using this manual for purposes other than those relating to the installation, use and maintenance of
the equipment is strictly prohibited.
00.2 Description of the equipment
The starlight uno is an equipment for polymerising photo-hardening composites. The light source
used is a very high-efciency monochromatic LED.
Unlike traditional halogen lamps, therefore, all the light being emitted by the starlight uno is used
to activate the camphorquinone photoinitiator. This means that it is possible to achieve excellent
polymerisation performance levels using decidedly less power and without emitting heat.
The device consists of an induction 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.
The 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).

34 starlight uno - manual of use and maintenance
00.3 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 specications of the composite material.
This equipment may be used only in a dentist’s surgery or out-patient’s department where there are
no inammable gases (anaesthetic mixtures, oxygen, etc.).
00.4 Safety requirements
Mectron will not accept any liability for direct or incidental personal injury or damage to property in
the following cases:
1 If the equipment is used for purposes other than that for which it is intended.
2 If the equipment is not used in accordance with all the instructions and requirements described
in this manual.
3 If the wiring system in the room where the equipment is used does not comply with the
applicable standards and appropriate requirements.
4 If any assembly operations, extensions, settings, alterations or repairs have been carried out
by personnel not authorised by Mectron.
5 If the environmental conditions in which the device is kept and stored do not comply with the
requirements indicated in the chapter on technical specications.

CAUTION: No alterations to this device are permitted.

CAUTION: The wiring system of the premises on which this device is used must comply with
the applicable standards and requirements.

WARNING: Qualied 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 point “00.3”). 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 this equipment on patients tted with pace-makers or any other implantable electronic
devices. This requirement applies equally to the operator.

WARNING: Point the beam of light directly at the material to be polymerised.
Do not use 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 towards 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.

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
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 lter out blue light).

WARNING: Contraindications.
Patients who have a case history of diseases of the retina should consult their optician beforehand
and be specically 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.
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

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 under point “07.0” 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, cleane and sterilise the optical protection and replace the
protective sheath. Carefully follow the instructions provided in chapter “07.0”.

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 efcient. 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
ammable 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 (Fig.3 - Ref.A). Do
not attempt to recharge the battery using a generic battery charger. This entails a risk of
explosion and re.

CAUTION: In the case that the end user, when operating in his or her own dental facility or
clinic, must subject the electro-medical equipment and systems to periodical inspections in order
to adhere to imposed requirements, test procedures that must be applied to electro-medical
equipment and systems to evaluate safety must be performed in conformance with standard EN
62353 ‘Electro-medical devices - Periodical inspections and tests to be performed after repair
interventions on electro-medical devices’.

36 starlight uno - manual of use and maintenance
01.0 Identication data
01.1 Identication data
An exact description of the model including the serial number of the equipment will make it easier
for our After-Sale Service to respond quickly and efciently to your queries.
Always provide the above information whenever you contact a Mectron Service Centre.
01.2 Identication plate of the charging unit
Each charging unit has an identication plate (Fig.1) on which the technical specications and the
lot number are indicated. The identication plate is xed to the underside of the equipment. The
remaining data are contained in this manual (see point “11.0”).
01.3 Identication data of the starlight uno handpiece
The serial number and some symbols are marked on each starlight uno handpiece (Fig.2).
Fig. 2
starlight uno
YYYY
328R00000
Fig. 1
STARLIGHT UNO
-CHARGER-
100-240 V - 50/60Hz. 15 VA
~
manufacturer
Mectron S.p.A.
Via Loreto 15/A
16042 Carasco - GE - Italy
Rx only
made in Italy
000000000 00000000
YYYY - MM - DD

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01.4 starlight uno battery module identication data
The batch number and the technical specications are marked on each starlight uno battery
module the batch number and the technical specications (Fig.3).
02.0 Testing
02.1 Testing of the equipment
All equipment manufactured by MECTRON is thoroughly checked and tested, including all
components.
During the testing procedure the components are subjected to a number of work cycles.
The tests highlight any malfunctioning due to faulty components.
This procedure ensures proper functioning and reliability of all components.
03.0 Delivery
03.1 Delivery of the equipment
The equipment contains electronic components that may be damaged by impacts even inside the
packaging. Special care must therefore be taken for both transport and storage.
All material shipped by MECTRON is checked at the time of shipment.
The equipment is delivered properly protected and packaged.
At the time of receipt of the equipment check it for possible transport damage. If any damage is
found, make a complaint to the carrier.
Fig. 3
Li-Ion Battery 3,6V 0,8Ah
00000000
00000000
YYYY-MM-DD

38 starlight uno - manual of use and maintenance
03.2 List of material included in the standard supply
1 starlight uno charging unit (Fig.4 - Ref.A).
1 starlight uno handpiece (Fig.4 - Ref.B).
1 Rechargeable lithium-ion battery module (Fig.4 - Ref.C).
1 Optical protection (Fig.4 - Ref.D).
50 Single use protective sheaths (Fig.4 - Ref.E).
1 Power supply cable for the charging unit (Fig.4 - Ref.F).
This equipment may vary at the time of promotional campaigns.
Fig. 4
D
B
A
E
C
F

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04.0 Installation
04.1 Safety requirements at the time of installation

WARNING: The wiring system of the premises where the equipment is installed and used must
comply with the applicable standards and the relevant electrical safety requirements.

WARNING: Risk of explosion. The equipment cannot operate in environments where there
are saturated atmospheres of ammable gases (anaesthetic mixtures, oxygen, etc.).

WARNING: Install the equipment in a place where it will be protected from shocks and from
accidental sprays of water or other liquids.

WARNING: Do not install the equipment above or in the vicinity of sources of heat. Make sure
that there is sufcient air circulating around the equipment.

WARNING: Do not insert metal objects into the handpiece of the charging unit (Fig.5 - Ref.B)
when the device is on.

CAUTION: The equipment is transportable, however it must be handled with care when it is
moved.

CAUTION: Do not expose the equipment to direct sunlight or to sources of UV light.

CAUTION: Always position the device in a way that the power plug is easily accessible at all
times; this is considered a insulation means.
Fig. 5
A
B

40 starlight uno - manual of use and maintenance
04.2 Connecting the equipment
In order to make the equipment operational it is necessary to proceed as follows:
1 Place the charging unit on a at surface.
2 Plug the power cable (Fig.4 - Ref.D) into the connector on the rear of the equipment (Fig.5 -
Ref.A) and then into the power outlet. The green power LED should light up (Fig.7 - Ref.A).
3 Connect the battery module to the handpiece by tightening the nut of the battery module to the
handpiece as shown in Fig.6.

CAUTION: Make sure that the voltage and frequency of the power-supply line match the values
indicated on the identication 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 parts.

CAUTION: Always position the device in a way that the power plug is easily accessible at all
times; this is considered a insulation means.
Fig. 6

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04.3 Description of the controls and
signalling lamps
Description of the controls (Fig. 4):
Ref. A - Green power LED.
Function: This indicates that the charging unit is
powered up.
Ref. B - Green battery LED.
Function This indicate that the starlight uno battery is
being charged.
Ref. C - test LED.
Function Green: Indicates that the light intensity is
suitable for effective therapy.
Yellow: Indicates that the light intensity is
insufcient.
Ref. D - on/off button
Function: This starts or stops a polymerisation cycle.
Fig. 7
D
BA C
Description of the acoustic and light signals of the handpiece (Table 1):
Function Button control Acoustic signal Light signal
FAST
polymerisation Brief pressure of on/off button 1 beep on starting exposure 1 beep on completing exposure 10 sec. Green LED steady on
SLOW RISE
polymerisation
Pressure of on/off
button for at least 2
seconds
1 beep when starting and 1 beep after
2 sec.
1 beep after 10 sec. of exposure
1 beep on completing exposure 20 sec.
Yellow LED
steady on
Interruption of
exposure cycle Brief pressure of on/off button during exposure 1 beep
Battery low signal.
The residual
charge is sufcient
for 6 cycles.
2 beeps on completing the exposure
cycle
Battery dead
signal
Pressure of on/off but-
ton for FAST or SLOW
RISE polymerisation 2 beeps - No light emission Green and yellow
LEDs ashing
Thermal protection
signal
3 beeps at the end of FAST exposure
cycle or in the middle of SLOW RISE
exposure cycle and functioning
interruption
Green and yellow
LEDs ashing

42 starlight uno - manual of use and maintenance
Description of light signals of the charging unit (Table 2):
Power LED Battery LED Test LED Position of the handpiece in the
charging unit Function
ON OFF Not in place Charging unit powered
ON ON In place Battery being recharged
ON OFF In place Recharging completed.
Battery charged.
ON OFF OFF Not in place Luminous ux absent.
ON OFF Yellow ON Not in place Luminous ux insufcient.
ON OFF Green ON Not in place Luminous ux suitable for ef-
fective treatment.
05.0 Battery
The starlight uno is powered by a rechargeable lithium-ion battery already contained inside the
handpiece, with no memory effect.
The 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.
05.1 New battery - rst charging
NOTE: The battery of the starlight uno is supplied in a partly charged condition.
To charge the battery completely:
1 Insert the handpiece into its housing in the charging unit (Fig.5 - Ref.B). The green battery LED
will light up (Fig.7 - Ref.B).
2 The charging phase has been completed when the green battery LED extinguishes.
05.2 Battery low signal
When the charge of the battery becomes low, after frequent use of the 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 dead state (see point
“05.3”).
Place the starlight uno back into the charging unit.
05.3 Battery dead signal
The battery of the starlight uno is dead if no light is emitted when the on/off button is pressed and
at the same time an acoustic signal is heard (2 beeps). Recharge the battery:
1 Place the handpiece in its housing in the charging unit (Fig.5 - Ref.B). The green battery LED
will light up (Fig.7 - Ref.B).
2 When the green battery LED extinguishes the recharging phase has been completed.

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05.4 Battery failed signal
When the low battery handpiece is placed in the charging unit and the battery green LED on the
charging unit remains off this means that there is a fault with the battery (Fig.7 - Ref.B).
NOTE: 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 Cut off the power supply to the charging unit for a few seconds (disconnect the power cable) -
All the LEDs will extinguish.
3 Reconnect the cable of the charging unit. The green power LED will light up.
05.5 Replacing the battery
To replace the faulty battery, unscrew the nut of the battery module, remove it and replace it with a
new one (Fig.6).
05.6 Safety requirements relating to the battery
The battery can cause damage to property and/or personal injuries such as burns if conducting
materials such as jewellery, keys or beaded necklaces come into contact with the exposed
terminals. The conducting material could close an electrical circuit (short circuit) and become very
hot. Make a habit of handling the device with care, particularly if it is placed inside a pocket, bag or
other container in which there are metal objects.
In the case of contact of the terminals with metal objects and consequent short circuit, the lamp
stops and it is necessary to reposition it on the battery charger to resume its operation.

WARNING: Do not insert metal objects into the handpiece of the charging unit (Fig.5 -
Ref.B) when the device is on.

WARNING: Keep the battery out of the reach of children.

CAUTION: Use only original Mectron batteries.

CAUTION: Recharge the battery only with the Mectron charging unit (Fig.3 - Ref.A). Do
not attempt to recharge the battery using a generic battery charger. This entails a risk of
explosion and re.

CAUTION: The battery should be recycled or disposed of in the appropriate manner in
accordance with the law. The battery should not be thrown away with normal waste. The
user will be liable for any damages caused by improper disposal of the battery.

CAUTION: Do not use the battery for purposes other than those for which it is intended.

CAUTION: Do not open, pierce or crush the battery. It contains toxic substances.

CAUTION: Do not burn the battery or expose it to a high temperature. There is a risk of
explosion.

CAUTION: Do not short-circuit the battery terminals. This could cause burns and re.

44 starlight uno - manual of use and maintenance
06.0 Use
06.1 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 efciency 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 and disinfect
the charging unit and the handpiece, cleanse and sterilise the optical protection and replace the
protective sheath. Carefully follow the instructions provided in chapter “07.0”.

WARNING: The protective sheaths are single use. Each protective sheath must be used for
one application only on a single patient.
Before using the starlight uno, the following are necessary:
1 Ensure the battery module is correctly connected to the handpiece;
2 Insert the single use protective sheath onto the handpiece (Fig.8 - Ref.A);
3 Fix the optical protection onto the handpiece (Fig.8 - Ref.B).
Fig. 8
A
B

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06.2 Safety requirements during use

WARNING: Never point the beam of light in the direction of the eyes.

WARNING: Before each cycle of exposure always make sure that the optical protection
has been tted onto the handpiece.

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.

WARNING: Do not insert metal objects into the handpiece of the charging unit (Fig.5 - Ref.B)
when the device is on.

CAUTION: During the rst 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.
06.3 Instructions for use
The starlight uno can be used in two different modes:
- 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
rst 3 seconds up to the maximum intensity.
Selecting the FAST exposure mode.
- To start the FAST exposure cycle press the on/off button on the handpiece briey (Fig.7 -
Ref.D). An acoustic signal will be heard (1 beep) and the green LED on the handpiece will light
up.
- After 10 seconds an acoustic signal will be heard (1 beep) and the green LED on the
handpiece will go out. The FAST cycle has been completed.
Selecting the SLOW RISE exposure mode.
- To start the SLOW RISE exposure cycle hold the on/off button on the handpiece down for
2 seconds (Fig.7 - Ref.D). At the start an acoustic signal will be heard and after 2 seconds
another acoustic signal to conrm the SLOW RISE cycle beginning. The yellow LED on the
handpiece will light up.
- After 10 seconds an acoustic signal will be heard (1 beep).
- After 20 seconds an acoustic signal will be heard (1 beep) ) and the yellow LED on the
handpiece will go out. The SLOW RISE cycle has been completed.
After the end of the treatment, remove the protective sheath used and place the starlight uno
handpiece back into the charging unit (Fig.5 - Ref.B).
NOTE: Interrupting the cycle.
Both in the FAST and in the SLOW RISE mode, the exposure cycle can be broken off at any time
by pressing the on/off button on the handpiece (Fig.7 - Ref.D).
NOTE: Additional exposure cycles.
At the end of any exposure cycle, it is possible to carry out one or more additional cycles by
pressing the on/off button on the handpiece again each time (Fig.7 - Ref.D).
For a quick guide to the signalling, see Tables 1 and 2.

46 starlight uno - manual of use and maintenance
06.4 Measuring the light intensity
To determine whether the light intensity is sufcient:
1 Place the tip (Fig.7 - Ref.A) at on the surface of the light-intensity sensor without pressing it
(Fig.7 - Ref.B);
2 Press the on/off button (Fig.7 - Ref.C) to switch on the lamp.
The test LED (Fig.7 - Ref.D) will indicate the working luminous ux measured:
- Green = luminous ux suitable for effective treatment;
- Yellow = luminous ux insufcient.

CAUTION: If the working luminous ux is not sufcient, do not proceed with the treatment on
the patient and carry out the following checks:
1 Check that the tip is not dirty;
2 Clean the tip (see point 7.1 - Cleaning and disinfecting the handpiece and the charging unit);
If these measures do not lead to improved performance, place the device out of commission (by
disconnecting it from the mains) and make sure that it cannot be started by unauthorised persons.
Any repair work on the device should be carried out by an authorised Mectron service centre.
06.5 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 heard. This
protection device will temporarily prevent use of the lamp for a few minutes. The yellow and green
LEDs ash.

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07.0 Cleaning, disinfection and sterilisation
This table is purely indicative.
For the complete cleaning, disinfecting and sterilization procedures of the individual parts, refer to
the paragraphs indicated in the table.

CAUTION: All the phases indicated in the following table must be performed, avoiding using
methods not referred to in that table.

WARNING: The protective sheaths are single use. Each protective sheath must be used for
one application only on a single patient.
Phase Paragraph Procedure Handpiece Charging
unit
Optical
protection
I07.1
Manual cleaning with
detergent solution and
disinfecting agent
X X
II 07.2.1 Immersion into enzymatic
detergent X
III 07.2.2 Check cleaning X
IV 07.2.3 Drying X
V07.2.4 Sterilisation X
07.1 Cleaning and disinfection of the handpiece and the charging unit

WARNING: Switch off the charging unit.
Before carrying out any cleaning and disinfection, disconnect the charging unit from the mains
power supply.
PREPARATION
- Remove the handpiece from the charging unit;
- Remove the optical protection from the handpiece;
- Remove the protective sheath from the handpiece.
MATERIALS NECESSARY
- Clean, soft cloths with low ber-release;
- Detergent solution (pH 6-9);
- Demineralised water;
- Disinfectant agent (Glutaraldehyde, Ghlorhexidine gluconate or Isopropyl alcohol 70%).
CLEANING METHOD
1 Clean the surface of the charging unit and the handpiece with a clean, soft and low bre
release cloth, dampened with a cleaning solution (pH 6-9) prepared according to the
manufacturer’s instructions;
2 Clean the surface of the charging unit and the handpiece with a clean, soft and low bre
release cloth, dampened with demineralised water to remove all residues of the cleaning
solution;

48 starlight uno - manual of use and maintenance
3 Dry the surface of the charging unit and the handpiece with a clean, soft and low bre release
cloth;
4 If you intend to disinfect, spray the disinfecting agent onto a clean, soft and low bre release
cloth and clean the surface of the charging unit and of the handpiece.

CAUTION: Do not use as disinfecting agents:
• Very alkaline products (pH > 9);
• Products containing sodium hypochlorite;
• Products containing hydrogen peroxide;
• Products containing abrasive substances;
• Acetone;
• Methylethylketone.
as they can discolour and/or damage the plastic materials.

CAUTION: Contact of liquid with the lamp terminals can cause damage and therefore voids the
warranty.

CAUTION: Contact of liquid with the LED causes damage and therefore voids the warranty.

CAUTION: Do not spray liquid directly onto the surface of the charging unit and/or of the
handpiece.

CAUTION: The casing of the charging unit and/or the handpiece are not protected against the
entry of liquids.

CAUTION: The charging unit and the handpiece should not be sterilised.
07.2 Cleaning and sterilisation of the optical protection
07.2.1 Manual cleaning

CAUTION: The only part of the device that can be sterilised is the optical protection.
MATERIALS NECESSARY
- Clean, soft cloths with low ber-release;
- Enzymatic detergent at pH 6-9;
- Water;
- Container for immersion in the enzymatic liquid;
- Brush with soft nylon bristles.

CAUTION: Do not use sharp-edged objects to clean the optical protection.
CLEANING METHOD
1 Prepare an enzymatic detergent solution with pH 6-9, as per the instructions of the
manufacturer;
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CAUTION: Once used, dispose of the enzymatic detergent correctly, do not recycle it.
2 Place the optical protection horizontally in a clean container and add enzymatic detergent
solution until the optical protection is covered completely;
3 Let the optical protection soak for 10 minutes at 40°C ±2°C;
4 During immersion in the enzymatic solution, delicately brush the surface of the optical
protection using the brush with soft nylon bristles to eliminate all traces of visible dirt;
5 Delicately brush the surface of the optical protection under running water using the brush with
soft nylon bristles;

49
starlight uno - manual of use and maintenance
EN

CAUTION: Do not use as disinfecting agents:
• Very alkaline products (pH > 9);
• Products containing sodium hypochlorite;
• Products containing hydrogen peroxide;
• Products containing abrasive substances;
•Acetone;
• Methylethylketone.
as they can discolour and/or damage the plastic materials
07.2.2 Check cleaning
Once the cleaning operations have been completed, visually inspect the optical protection under an
adequate source of light, if necessary using a magnifying glass 2.5X, paying attention to the details
that could conceal dirt residue (threading, cavities, grooves) and, if necessary, repeat the cleaning
cycle if dirt is still visible. Finally, check the integrity of those parts and those elements that could
have deteriorated during use.
07.2.3 Drying
Thoroughly dry all parts of the optical protection with a soft low bre release cloth, possibly blowing
with compressed air.
07.2.4 Sterilisation

CAUTION: Carry out sterilisation only in a steam autoclave. Do not use any other
sterilisation procedures (dry heat, radiation, ethylene oxide, gas, low-temperature plasma, etc.).

CAUTION: The optical protections are made from materials able to withstand a maximum
temperature of 135°C for a maximum period of 20 minutes.

WARNING: Infections control - Sterilisable parts.
To avoid infection by bacteria or viruses, carefully remove any remaining organic dirt prior to
sterilisation.
STERILISATION PROCEDURE
Seal the optical protection individually in a disposable bag for sterilisation and proceed with the
process of sterilisation in a steam autoclave.
The sterilization process, in a steam autoclave, guarantees SAL 10-6 by setting the parameters
indicated below:
- Type of cycle: 3 times Pre-vacum (pressione min. 60 mBar).
- Minimum sterilisation temperature: 132 °C (interval 0 °C ÷ +3 °C).
- Minimum sterilisation time: 4 minutes.
- Minimum drying time: 10 minutes.
All the stages of sterilisation must be carried out by the operator in accordance with UNI EN ISO
17665-1:2007, UNI EN ISO 556-1:2002 and ANSI/AAMI ST 46:2002.

50 starlight uno - manual of use and maintenance
08.0 Disposal procedures and precautions
-

CAUTION: This device contains a LITHIUM-ION battery. 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;
- 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.;
- Failure to comply with the foregoing points may entail punishment in accordance with Directive
about waste of electrical and electronic equipment WEEE.

WARNING: Hospital waste.
Treat the following items as hospital waste:
- Optical protection, when worn or broken;
- Protective sheath, at the end of each application.