DENTSPLY DeTrey SmartLite PS Bedienungsanleitung

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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SmartLite™ PS Scientific Compendium

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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SmartLite™ PS Scientific Compendium

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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SmartLite™ PS Scientific Compendium

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

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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SmartLite™ PS Scientific Compendium

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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SmartLite™ PS Scientific Compendium

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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