DENTSPLY DeTrey SmartLite PS User manual

Table of contents
1Introduction ................................................................................. 3
2SmartLite PS Design ................................................................... 3
2.1 LED-Tip ..........................................................................................................3
2.2 Hand piece.....................................................................................................4
2.3 Charger ..........................................................................................................4
3Intensity and Spectral Output .................................................... 4
4Light output stability................................................................... 6
5Thermal radiation ........................................................................ 7
5.1 In-vitro tooth heating study..........................................................................7
5.2 Temperature of the LED Tip .........................................................................8
6Curing performance .................................................................... 9
6.1 Depth of Cure according to ISO 4049:2000 ................................................9
6.2 Barcol hardness..........................................................................................10
6.3 Compressive strength ................................................................................11
7Clinical data ............................................................................... 12
7.1 Consumer preference evaluation ..............................................................12
7.2 Clinical post-marketing surveillance study, Republic of South Africa ..14
8Conclusion................................................................................. 16
9Indications, contra-indications, warnings, and precautions . 16
10 Directions for use...................................................................... 18
10.1 Installation and charging ...........................................................................18
10.2 Operation.....................................................................................................19
10.3 Maintenance ................................................................................................20
11 Guarantee terms........................................................................ 21
12 Specifications ............................................................................ 22
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SmartLite™ PS Scientific Compendium
1 Introduction
Unlike conventional halogen lamps, light emitting diodes (LED) produce light in the visible
range of the electromagnetic spectrum via quantum mechanical effects using doped
semiconductors. LED lamps emit highly efficient light in a limited wavelength range. The LED
needs less power than a halogen light bulb, in which the light is generated by heating a
tungsten filament in the presence of a halogen gas.
Due to the fact that the emission spectrum of the blue LED closely matches the absorbance
peak of camphorquinone - the most commonly used photo initiator in visible light cured
dental materials -, the LED units represent a considerable improvement over halogen lamps
due to the improved conversion efficiency and longer LED life time.
Thus, this technology is an ideal basis for cordless devices improving the convenience of the
curing procedure in the dental surgery. Noisy and uncomfortable cooling fans, necessary in
traditional Quartz-Tungsten-Halogen (QTH) curing lights, are not needed due to the higher
efficiency of LEDs.
SmartLite PS is an LED curing light that is small and easy to use, yet powerful and swift in
curing. The following information will provide details on the curing performance and
demonstrate the high efficiency and safety of this new curing device. Properties that make it
ideal as replacement of traditional QTH curing units.
2 SmartLite PS Design
2.1 LED-Tip
The black anodized aluminium tip of the SmartLite PS comprises a grip, enabling the
operator to rotate the tip in an easy manner. Furthermore, an easy orientation of the LED-tip
is given even in situations of low brightness and limited space by a crosshair on the backside
of the tip, indicating the direction of the light.
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2.2 Hand piece
Due to the compact design of the hand piece the SmartLite PS is very easy and precise to
handle. Pressing the ON/OFF button activates the 10-sec standard cure. Several visual and
acoustic signals give the operator information on the battery status and/or if the LED-tip is
not properly connected to the hand piece.
The hand piece comprises a rechargeable Nickel-Metal-Hydride (NiMH) battery, which
provides a minimum of 150 curing cycles at 10 seconds with a stable power output even at a
low battery charging status. This is achieved by means of a microprocessor-controlled
technology.
2.3 Charger
Four charger types are available adjusted to the specific plugs and voltage of the respective
countries:
EU-plug: 220 – 240 V
UK-plug: 220 – 240 V
US-plug: 110 – 130 V
Japan-plug: 90 – 110 V
3 Intensity and Spectral Output
By using the Cure Rite™ photometer the intensity of a standardised area is measured and
directly indicated for all lamps.
The SmartLite PS has a powerful 5W LED with an average light output of more than 950
mW/cm2. This value is comparable to most other LED lights and some more powerful
halogen lights (Figure 1).
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SmartLite™ PS Scientific Compendium
0 250 500 750 1000 1250
Light intensity [mW/cm2]
SmartLite PS
Epilar FreeLight 2
Starlight Pro
L.E.Demetron I *
Spectrum800@800
Light intensity determined with CureRite
Figure 1 Light intensity of SmartLite PS compared to other curing lights
The SmartLite PS does not - unlike the widely used Quartz-Tungsten-Halogen (QTH) lamp -
emit light with wavelengths beyond the absorbance range of camphorchinone (CQ). CQ is
the most commonly used photo initiator in almost all visible light cured dental materials. Thus
the light emitted by the SmartLite PS corresponds to the absorbance maximum of CQ, which
ensures a very efficient activation and curing of the restorative material (Figure 2).
350 400 450 500 550
Wavelength [nm]
SmartLite PS
QTH light
Absorbance CQ
Figure 2 Emission spectrum of the SmartLite PS and of a QTH light compared to the
absorbance spectrum of CQ
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4 Light output stability
It is well known from conventional halogen lights (QTH) that the curing performance is
strongly dependent on the bulb. Towards the end of the bulb’s lifetime the output is seen to
drop dramatically. As this can not be checked automatically, it is of outmost importance to
test the QTH curing lamp on a regular basis in order to detect any deterioration in its curing
performance. The LED technology offers the advantage that the LED light source does not
deteriorate over the life time of approximately 10.0000 hours and therefore does not require
maintenance or constant monitoring.
As shown in Figure 3, a fully charged battery provides approx. 150 ten-second cures
(approx. 25 minutes operating time) with constant light output. Therefore, under most
conditions of use, the device only needs to be recharged over night.
When the battery light flashes red (fast), the battery needs to be recharged. Another
2 minutes exposure time is then left for completion of the treatment. Light output is not
reduced during this period. After these 2 minutes, the device switches off automatically and
continues to flash red (slowly) indicating the need to recharge.
600
800
1000
1200
0 20 40 60 80 100 120 140 160 180
Number of 10sec cures
Light output [mW/cm2]
Figure 3 Light output upon repeated cycles.
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5 Thermal radiation
Besides the emission of visible light in the spectral range of approximately 400-500 nm all
curing lamps radiate heat as well. The amount of heat that is radiated towards the tooth
depends on the output power and the exposure time. A balance between high light power
and low heat irradiation is needed to avoid the risk that heat may have on the pulp tissue and
the oral mucosa.
5.1 In-vitro tooth heating study
A tooth heating study was conducted at the Department of Oral Rehabilitation, Medical
College of Georgia (head: Professor F. Rueggeberg, DDS, MS). The purpose of this
investigation was to simulate and determine in vitro the intra-pulpal temperature rise in a
model using extracted human bicuspids (Figure 4) comparing the SmartLite PS to a variety
of commercial light-curing units (Figure 5).
Light tip
water outlet
thermocouple leads
to cold junction
compensator
Inlet for
temperature-controlled water
from infusion pump
thermocouple
j
unction
1 mm
0.75 - 1 mm
Tooth roots
immersed in a
thermostatically
controlled water bath
Figure 4 In-vitro simulation of light curing and measurement of intra-pulpal temperature
rise (Rueggeberg)
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SmartLite™ PS Scientific Compendium
012345
TEMPERATURE (°C)
STARLIGHT Pro
SmartLite PS
Optilux 501
LEDemetron I
Spectrum 800@800
FreeLight 2
CURING CONDITION
PEAK INTRAPULPAL TEMPERATURE RISE
SIMULATING A 10 SEC CURE
012345
TEMPERATURE (°C)
STARLIGHT Pro
SmartLite PS
Optilux 501
LEDemetron I
Spectrum 800@800
FreeLight 2
CURING CONDITION
PEAK INTRAPULPAL TEMPERATURE RISE
SIMULATING A 10 SEC CURE
PEAK INTRAPULPAL TEMPERATURE RISE
SIMULATING A 10 SEC CURE
Elipar Freelight 2
Spectrum 800
L. E. Demetron 1
Figure 5 Intra-pulpal temperature rise after 10s exposure with various curing units
The temperature rise after a 10sec exposure using the SmartLite PS ranged from 2.4 to
2.8° C and was significantly lower than of the following commercially available LED and
halogen units: L. E. Demetron 1, Elipar FreeLight 2, Optilux 501, and Spectrum800.
Moreover, longer exposure times have shown that the SmartLite PS emits and transfers less
heat onto the tooth than other widely used LED and halogen curing lights.
5.2 Temperature of the LED Tip
ISO 60601 requires that equipment parts that may have a brief contact with a patient must
not be warmer than 50 °C. If SmartLite PS is used according to the directions for use, which
request a waiting period of 30 seconds between 10-second curing cycles, the device is in
compliance with the above-mentioned standard.
If, in deviation from the directions for use, the device is used with shorter waiting periods or
for longer curing cycles, the temperature of the LED Tip may rise above 50 °C. However,
experiments for curing cycles up to 30 seconds long have shown that, if typical direct
restorative procedures are simulated, the resulting temperatures do not create any hazard
regarding tissue compatibility and do not negatively affect the lifespan of the LED light. Still,
SmartLite PS must not be used for the luting of indirect restorations as this process is
associated with many consecutive and long curing cycles.
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6 Curing performance
6.1 Depth of Cure according to ISO 4049:2000
The depth of cure of a restorative material correlates directly with the light output of a curing
light. The higher the intensity of a curing light the more efficient the depth of cure. This
usually is the result of a higher degree of conversion, which leads to a stronger material and
an increase in durability of the resulting restoration.
Depth of cure was measured for SmartLite PS, along with other LED lights, and a strong
halogen light according to the method described in the ISO 4049:2000.
It is important to note that this particular method defines the depth of cure as 50 % of the
actual thickness of the cured cylindrical specimen: A sample of the material is exposed to the
light source and the un-polymerised material is scraped away using a spatula. The thickness
of the remaining sample is then divided by 2 resulting in the depth of cure according to ISO.
The results are shown in Figure 6 and Figure 7.
0,0
0,5
1,0
1,5
2,0
2,5
3,0
SmartLite PS Starlight Pro L.E.Demetron I Spectrum 800
@800
Depth of Cure [mm]
Figure 6 Depth of Cure (ISO 4049:2000) of Spectrum TPH A2 after a 10sec cure with
various curing units
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0,0
0,5
1,0
1,5
2,0
2,5
Depth of Cure [mm]
SmartLite PS Starlight Pro L.E.Demetron I Spectrum 800
@800
Figure 7 Depth of Cure (ISO 4049:2000) of Spectrum TPH A4 after a 10sec cure with
various curing units
The above data demonstrate that even for dark shades such as SpectrumTPHA4 a depth of
cure of 2mm thickness can be achieved with SmartLite PS after 10sec exposure .
6.2 Barcol hardness
Another method to determine the curing performance of a curing light is to measure the
hardness of the exposed surface and the hardness at a given depth using Barcol hardness.
By curing a 2mm thick sample of the restorative material (Spectrum TPH A2, A4) the
obtained hardness values for the illuminated (top) and the non-illuminated (bottom) side of
the sample, as well as the bottom/top hardness ratio, were measured. The results
demonstrate again that a 2 mm depth of cure can be achieved by using SmartLite PS for
10 seconds (Figure 8, Figure 9).
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SmartLite™ PS Scientific Compendium
Barcol hardness: Spectrum TPH A2 (10 sec exposure)
50
55
60
65
70
75
80
934-harndess
80
85
90
95
100
105
bottom/top [%]
top hardness 72 72 72 73 72
bottom hardness 70 71 69 69 71
bottom/top [%] 97 99 96 95 98
SmartLite PS Epilar FreeLight 2 Starlight Pro L.E.Demetron I Spectrum 800@800
Figure 8 Barcol hardness of Spectrum TPH A2 after a 10sec cure with various curing
units
Barcol hardness: Spectrum TPH A4 (10 sec exposure)
50
55
60
65
70
75
80
934-harndess
80
85
90
95
100
105
bottom/top [%]
top hardness 72 72 73 73 70
bottom hardness 66 70 64 67 66
bottom/top [%] 92 97 88 92 94
SmartLite PS Epilar FreeLight2 Starlight Pro L.E.Demetron I Spectrum 800@800
Figure 9 Barcol hardness of Spectrum TPH A4 after a 10sec cure with various curing
units
6.3 Compressive strength
Additionally, measurements of the curing performance of the SmartLite PS were
compared to that of the Spectrum800@800 by measuring the compressive strength of
EsthetX A2 and A4 and Spectrum TPH A2 and A4 shades, respectively. Results are
shown in Figure 10. The obtained values for the compressive strength of the cured
materials confirm that there is no difference between the curing performance of the
SmartLite PS and the Spectrum800 at 800 mW/cm2.
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SmartLite™ PS Scientific Compendium
0
100
200
300
400
TPH A2 TPH A4 Esthet.X A2 Esthet.X A4
Compressive Strength [MPa]
Spectrum800@800
SmartLite PS
Figure 10 Compressive strength of Spectrum TPH A2, A4, EsthetX A2, A4 cured with
SmartLite PS and Spectrum 800@800.
7 Clinical data
7.1 Consumer preference evaluation
General dental practitioners were given the opportunity to use SmartLite PS for standard
restorative treatment over a time period of several weeks. They were asked to report on their
experience and to rate their grade of satisfaction with the light by means of a questionnaire.
Results are listed in Tables 1 to 3.
The data show a high degree of customer satisfaction:
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SmartLite™ PS Scientific Compendium
Consumer Preference Evaluation
---20%80%
Overall rating of design
and function
---40%60%
Battery capacity
---40%60%
Ergonomics of hand
piece with LED tip
attached
---20%80%
Functionality of charging
unit
Very
Poor
PoorSatis-
factor
y
GoodVery
good
Table 1 Consumer Preferences
Consumer Preference Evaluation:
What practitioners liked about SmartLite PS
• Small size
• Easy to use
• Light in weight
• Well balanced
• Excellent access
anywhere in the mouth
•Notclumsy
• Efficient
•Powerful
• Excellent charging
mechanism
• Directness of light
source
•Protectivesleeve
• Shield system
Table 2 Advantageous Properties of SmartLite PS
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Consumer Preference Evaluation:
If presently in need for an additional curing light,
would practitioners purchase SmartLite PS?
Not at all likely0
Not very likely0
Somewhat likely0
Very likely60%
Extremely likely40%
Table 3 Preference for additional curing light
7.2 Clinical post-marketing surveillance study, Republic of South Africa
Main Investigator
Dr. Paul D. Brandt, University of Pretoria (ZA)
Objective
The objective of this investigation is to prove that the performance of posterior composite
restorations is the same when cured with
a) a conventional halogen curing light with 20-second curing cycles.
b) SmartLite PS with 10-second curing cycles.
Design
Prospective controlled postmarketing surveillance investigation.
Under the conditions of general daily practice, each of up to 10 investigators places eighty
Class I and II posterior composite restorations and monitors the performance of these
restorations for up to 16 months.
Half of the restorations are cured with a halogen curing light (with an output of more than 300
mW/cm², measured with a CureRite device) which is routinely used in the surgery. The
curing time for each 2mm-increment of composite is 20 seconds.
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SmartLite™ PS Scientific Compendium
The other half of the restorations is light-cured with SmartLite PS. The curing time for each
2mm increment of composite is 10 seconds.
The investigators monitor the performance of the restorations with regard to any report of
post-operative sensitivity or other side effects received from the patient and/or when the
respective restorations become available for inspection during routine examinations.
Patient/Case Selection
Routine patients in need for direct tooth-coloured posterior restorations (Class I and II
cavities in molars and premolars). Tooth to be vital on the day of treatment, with no
symptoms of pulp inflammation/irritation, and not in need of direct pulp capping or endodontic
treatment. There should be no hypersensitivity or sensitivity to percussion.
For inclusion into the study, the following additional requirements have to be met:
Successful cavity isolation (no contamination)
Patient was expressly asked to report back if any sensitivity occurs
Light output was measured immediately after treatment and exceeded 300mW/cm²
for the halogen curing light and 720 mW/cm² for SmartLite PS.
Reporting
Reports to DENTSPLY are provided by the investigators by means of a set of forms for each
restoration to be monitored.
Interim report August 2003:
First data from 4 investigators were analysed and prove that for all criteria measured there is
no difference in safety and efficacy between a standard halogen light with a curing time of 20
seconds per increment and SmartLite PS with a curing time of 10 seconds per increment for
the curing of posterior composite restorations. Data on post-operative sensitivity are provided
in Figure 11.
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SmartLite™ PS Scientific Compendium
Figure 11 Postmarketing Surveillance Study – Interim Report as of August 2003
8 Conclusion
The information that is provided in this document represents a small excerpt of all
investigations performed internally and externally, proving that the SmartLite PS fully equals
strong QTH curing lights like the Spectrum 800 with regard to curing performance.
The convenient size, the ease of use and the device’s lightness makes it an ideal curing light
for all-day usage within direct restorative treatment.
9 Indications, contra-indications, warnings, and precautions
Indications
Intra-oral light curing of direct restorative materials, adhesives, and sealants which cure at a
wavelength of 450 - 490 nm.
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SmartLite™ PS Scientific Compendium
Contra-indications
Use for indirect restorations:
SmartLite PS should not be used for curing of luting cements for indirect restorations (e. g.
ceramic inlays) as continuous curing cycles will result in heat build-up of the LED tip which
may cause discomfort or burns.
Use in patients prone to photobiological reactions:
Do not use the SmartLite PS on patients with a history of photobiological reactions (including
patients with Urticaria solaris or erythropoietic protoporphyrie) or those currently undergoing
treatment with photosensitising pharmaceuticals.
Warnings
SmartLite PS should not be used as a tissue retractor, as this may damage the connection
between LED tip and hand piece.
Do not use a damaged device, e. g. if among others the glass cover of the LED Tip is
scratched, broken or missing.
Do not use for voltages different to the range indicated on the charging unit.
Note: To disrupt the power supply, the charging device has to be plugged out.
Always unplug the charger before disinfecting.
Precautions
Anyone with a history of retinopathy should consult their eye specialist before operating this
unit. Use the SmartLite PS extremely carefully and comply with all the necessary safety
precautions (including wearing suitable, light filtering safety glasses).
Anyone who has had a cataract operation may be especially sensitive to light and should be
advised against undergoing treatment with a SmartLite PS unless adequate safety
precautions are taken such as wearing safety glasses which filter out blue/violet and ultra-
violet light.
Do not use a device which has not been properly disinfected (see Chapter Maintenance).
Protect LED Tip from contamination by applying a disposable, single patient use sleeve
(DENTSPLY Disposa-Shield®).
Never aim the light directly at unprotected soft tissues, as this may cause injury or irritation.
Do not aim the light at eyes.
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SmartLite™ PS Scientific Compendium
Light reflected from the tooth surface may also injure eyes. Use the protective shield supplied
with the unit or suitable safety glasses, which shield effectively against blue spectrum light.
If time intervals between exposures are too short, the LED tip may overheat and potentially
cause soft tissue injury. Therefore, wait for at least 30 seconds between exposures.
Limit the action of the light to the area being treated.
10 Directions for use
10.1 Installation and charging
1 Plug in charging unit.
2 Insert the hand piece [1]into the charging unit [3].
The battery light will be flashing green, indicating ongoing charging of the battery.
3 Charge the device for at least 10 hours prior to first use. Complete charge of the curing
light is indicated by a continuously green light.
4 The completely charged device allows approx.150 ten-second cures (total operating
time approx. 25 minutes). Thus, under most conditions of use, the device will normally
need recharging at the end of each practice day.
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SmartLite™ PS Scientific Compendium
10.2 Operation
Operation at a glance
1.1) ON/OFF KEY
Activates device and starts or disrupts the
10-second exposure cycle.
1.2) BATTERY LIGHT
Continuously green
(only indicated when SmartLite PS hand
piece is inserted into the charger):
SmartLite PS is fully re-charged and ready
for operation
Flashing green
(only indicated when SmartLite PS hand
piece is inserted into the charger):
SmartLite PS is still being re-charged.
Fast flashing red:
2 minutes exposure time left - SmartLite PS
needs re-charging.
Slowly flashing red:
Battery is fully discharged (no exposure time
left) and needs re-charging.
1. Attach the LED Tip [2]to the hand piece [1]. The device is now ready for operation.
2. Protect LED Tip from contamination by applying a disposable, single patient use sleeve
(DENTSPLY Disposa-Shield®)
3. Attach the eye protecting shield to the tip or use safety glasses which shield effectively
against blue spectrum light.
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SmartLite™ PS Scientific Compendium
4. Adjust the LED Tip: The LED Tip rotates by 360°, thus the position of light emission
may be freely adjusted. The tip must be adjusted to an angle that most optimal curing of
the restoration is possible. The tip must not touch the restoration material but should be
positioned as close as possible to the restoration.
5. Polymerisation: Shortly press the ON/OFF key [1.1]. The start of the 10-second
exposure cycle is indicated by an acoustic signal. The end of 10-second exposure cycle
is likewise indicated by an acoustic signal.
For detailed information on curing times for DENTSPLY light cured products, please see
the Curing Guide supplied. For products other than those from DENTSPLY, please refer
to the curing times given by the respective manufacturer.
Wait for at least 30 seconds between exposures. If time intervals between exposures are
too short, this may lead to a potentially tissue injurious overheating of the LED Tip.
10.3 Maintenance
Prevention of cross infection, cleaning, disinfection, and storage
The use of the sleeve is an additional precautionary measure against contamination and
does not substitute disinfection of the device.
After use, remove sleeve. Clean and disinfect LED Tip and hand piece with commercial
alcohol based surface disinfecting solution (Dürr FD 322, Henkel Incidin Liquid, S&M
Mikrozid Liquid, B.Braun Meliseptol rapid). Keep other solvents or flammable liquids as well
as intense sources of heat away from the unit as they may damage its plastic housing.
Always safeguard charger, hand piece, and LED Tip against moisture as this may cause
electrical short-circuit or dangerous malfunction.
Light output control
Make sure that the LED aperture is clean and scratch-free, otherwise light output will be
reduced and may be insufficient for proper curing of the material.
Control of light efficiency is recommended (e. g. by using CureRite™). The CureRite output
should exceed 730 mW/cm².
Battery maintenance
The battery needs a total of 10 hours to be fully re-charged.
When the battery is charging, the battery light flashes green.
Upon complete recharging, the battery light remains continuously green.
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