SmartLite PS Directions for Use Feb 2004

CONTRAINDICATIONS Use for indirect restorations: The SmartLite PS LED curing light should not be used for the curing of luting cements for indirect restorations (e.g. ceramic inlays), as no data exist to support the use of SmartLite PS with indirect restorations. Use in patients prone to photobiological reactions: Do not use the SmartLite PS LED curing light 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 The SmartLite PS LED curing light should not be used as a tissue retractor, as this may damage the connection between LED tip and handpiece. 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 LED curing light 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 LED curing light unless adequate safety precautions are taken such as wearing suitable, light filtering safety glasses. 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. Light reflected from the tooth surface may also injure eyes. Use the protective shield supplied with the unit or suitable, light filtering safety glasses. If time intervals between curing cycles are too short, this will result in heat build-up of the LED tip which may cause discomfort or tissue irritation. For continuous operation, wait for at least 30 seconds between curing cycles. Limit the action of the light to the area being treated. INSTALLATION AND CHARGING 1. Plug in charging unit. 2. Insert the handpiece 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.

5

4. The completely charged device allows approx.150 ten-second cures (total operating time approximately 25 minutes). Thus, under most conditions of use, the device will normally need recharging at the end of each practice day. OPERATION 1. Attach the LED Tip 2 to the handpiece 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 suitable, light filtering safety glasses. 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 curing cycle is indicated by an acoustic signal. The end of 10-second curing 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. For continuous operation, wait for at least 30 seconds between curing cycles. If time intervals between curing cycles are too short, this will result in heat build-up of the LED tip which may cause discomfort or tissue irritation. MAINTENANCE 1. 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 handpiece 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, handpiece and LED Tip against moisture as this may cause electrical short-circuit or dangerous malfunction. 2. 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™ light intensity testing device). The light intensity measured by CureRite testing device should exceed 730 mW/cm2. 3. Battery maintenance The battery needs approximately 10 hours to be fully re-charged. During the battery’s being re-charged, the battery light is flashing green. Upon complete recharging, the battery light remains continuously green. Fully charged, the battery has a capacity of approximately 150 ten-second cures (approximately 25 minutes operating time). 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 curing 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.

6

The maximum capacity of the rechargeable battery will be reached after initial charging cycles. To maintain the maximum capacity of the rechargeable battery, discharge the device by regular use at least every 6 months and recharge the battery immediately thereafter. If the SmartLite PS LED curing light is not used during an extended period (e.g. holidays) leave the handpiece in the operable charger. Otherwise the batteries may become deeply discharged, which may cause irreversible damage to the battery. 4. High voltages are present inside the charger. Do not open charger or the handpiece. Use only under dry conditions. Do not use if the charger is wet. Store dry. Only authorised technicians should repair the SmartLite PS LED Tip, handpiece or charger. SERIAL NUMBER The serial number should be quoted in all correspondence, which requires identification of the product. ACCESSORIES SmartLite PS LED Tip SmartLite PS Eye Protection Shield SmartLite PS (230 V, EU, Model no. 100EU) Charger SmartLIte PS (120 V, US, Model no. 101US) Charger SmartLite PS (230 V, UK, Model no. 102UK) Charger SmartLite PS (100 V, JPN, Model no. 103JPN) Charger DENTSPLY Disposa-Shield

Reorder no. Reorder no. Reorder no. Reorder no. Reorder no. Reorder no. Reorder no.

644.40.050 644.40.051 644.40.015 644.40.025 644.40.035 644.40.045 A880065

ENVIRONMENTAL NOTE Battery recycling: This device is provided with a nickel metal hydride battery. For environmental reasons, please dispose of the device according to local environmental guidelines or regulations. GUARANTEE TERMS DENTSPLY grants a 1-year guarantee on handpiece and charger and a 6-month guarantee on the LED Tip commencing on the date of purchase. Within the guarantee period, DENTSPLY will eliminate free of charge any defects in the appliance resulting from faults in material or workmanship either by repairing or exchanging parts or exchanging the whole device at DENTSPLY’s discretion. Not covered by this guarantee: Damage arising from improper use (operation with incorrect current/voltage, unsuitable power point, breakage, cleaning by other than the recommended methods), normal wear and defects which have a negligible effect on the value or operation of the appliance. The guarantee becomes void if repairs are undertaken by unauthorised persons. This guarantee extends to every country where this device is supplied by DENTSPLY or its appointed distributor and where no import restrictions or legal regulations hinder or prevent service being given under guarantee.

7

Service under guarantee does not affect the expiry date of the guarantee. The guarantee on parts or entire devices which are exchanged ends when the guarantee on this device expires. In the event of a claim of this device, return the complete device (charging unit and the LED curing light) together with the invoice to your dealer or send it to your nearest DENTSPLY Service Center. All other claims including those for damages resulting from this guarantee are excluded unless our liability is legally mandatory. SPECIFICATIONS AND EQUIPMENT CLASS AC Supply connection

EU charger (Model no. 100EU): 220...240 V ~ 50...60 Hz 2.5 W US charger (Model no. 101US): 110...130 V ~ 50...60 Hz 2.5 W UK charger (Model no. 102UK): 220...240 V ~ 50...60 Hz 2.5 W JPN charger (Model no. 103JPN): 90...110 V ~ 50...60 Hz 2.5 W

Power input

2.5 W

Equipment class

Class II

Protection from electric shock

Type BF

Protection from ingress of liquids

IP X4

Operation

Continuous operation with intermittent loading, duty cycle of 10 seconds ON / 30 seconds OFF Ambient temperature: 10 - 32 °C Relative humidity: 30 - 100% Atmospheric pressure: 500 hPa to 1060 hPa

Storage

Ambient temperature: -10 - +35 °C / 14 - 95 °F Relative humidity: 30% - 80% (non-condensing) Atmospheric pressure: 500 hPa to 1060 hPa

Transport

Ambient temperature: -10 - +60 °C / 14 - 140 °F Relative humidity: 30% - 80% (non-condensing) Atmospheric pressure: 500 hPa to 1060 hPa

Battery performance

Handpiece will operate approximately 25 minutes time starting upon complete recharging. Time to battery recharge: approximately 10 hours

Battery over current protection

Resetable fuse

Battery life

Minimum 400 full recharge cycles

Light emitting diode

5 W LED

8

Average light intensity

950 mW/cm2 (CureRite output)

Output peak wavelength range

450 - 490 nm (intensity maximum at 460 nm)

Unit handpiece dimensions

Length: 159 mm Width: 28 mm

Tip dimensions

Length: 93 mm Width: 14 mm

Unit weight

Handpiece and tip: 100 grams Charger: 45 grams

Additional symbols

Consult accompanying documents Battery recycling

If you have any questions, please contact: Manufacturer: DENTSPLY DeTrey GmbH De-Trey-Str. 1 78467 Konstanz GERMANY Phone +49 (0) 75 31 5 83-0

Distributor: DENTSPLY Limited Hamm Moor Lane Addlestone, Weybridge Surrey KT15 2SE Phone (0 19 32) 85 34 22

© DENTSPLY DeTrey 2004-02-03

9