Whitening Lamp 2 GB Product Information D Produktinformation GB Whitening Lamp 2 High tech in tooth whitening High power LED technology with highly focused light spectrum. High life expectancy of LED s. Emits no harmful UV rays. Covering of the skin is not necessary. Patients must only wear safety goggles. No harmful heat development. Special settings for sensitive teeth and single tooth whitening. Light output can be adjusted; i.e. at 2nd or 3rd cycle the light intensity can be reduced. Intuitive touch screen operation. Optimal together with WHITEsmile LIGHT WHITENING GEL. Page 5 ff LIGHT WHITENING D Whitening Lamp 2 Hightech in der Zahnaufhellung Hochleistungs-LED-Technologie mit einem hochintensiven, fokussierten Lichtspektrum. Ohne schädliche UV-Strahlen. Die Patienten müssen nur eine Schutzbrille tragen, das Abdecken der Haut ist nicht notwendig. Keine schädliche Hitze entwicklung. Verschiedene Zahnaufhellungsprogramme für eine fl exible Behandlungsplanung: z.b. kann die Lichtintensität bei Bedarf beim 2. oder 3. Zyklus reduziert werden. Spezial einstellungen für sensible Zähne und Einzelzahn auf - hellung. Lichtoutput variierbar. Intuitive Touchscreen Steuerung. Optimal zusammen mit WHITEsmile LIGHT WHITENING GEL. ab Seite 15
GB User Instructions for Whitening Lamp 2 Contentsnhalt Technical Information... 6 Physical Specifications... 6 1. Notice... 6 2. Components... 7 3. Installation... 7 4. Operation of user interface... 8 5. Adjusting lamp head in front of patient... 10 6. Power supply control box located under user interface box...11 7. Whitening procedure operation of the lamp...11 8. Troubleshooting...11 9. Cleaning...11 10. Note...11 Signs and Symbols... 12 11. Warranty... 12 Declaration of Conformity... 13 GB Please see instruction video at www.whitesmile.com D Beachten Sie das Anleitungsvideo auf www.whitesmile.de
6 GB User Instructions for WHITENING LAMP 2 WHITENING LAMP 2 is an electronic unit that controls 3 blue LED (Light Emitting Diodes): This unit is used to optimise dental tooth whitening. Technical Information Power supply 100-240 V ~ 50 Hz 60 Hz Max. input power 35W Time-delay fuse 5X20 250V 2A Output power 30 W l = 460nm High-intensity lighting source by blue led 4.000-10.000 mw / cm², 3 LED (12.000-30,000 mw) Protection against electric Class I shock Device working and enviromental conditions Stoarge Temperature -20 C to 45 C Working Temperature 15 C to 30 C IMQ and VDE accepted. Physical Specifications Power cord plug Power cord length Dimensions Total weight SCHUKO 2,50 m 142 166 63 cm (max dimensions of build up lamp) 63 x 149 x 63 cm, folded ca. 9 kg 1. Notice Warning: Please refer to the manual! Medical device CE 93/42: CLASS I WHITEsmile GmbH Weinheimer Strasse 6 69488 Birkenau Germany 100-240 V ~ 50 60 Hz 35 W WHITENING LAMP 2 is suitable to be used with every type of in-office whitening material based on hydrogen peroxide as active ingredient which is CE marked, according to CE directive 93 / 42 Medical Device. Its usage is allowed only in hospital environment, in clinics and in dental studios. It must be used only by experts, qualified for whitening treatments. The manufacturer accepts no responsibility in the event of: actions or repair carried out by persons not authorized by the manufacturer or importer. use on an electrical system not in conformance with the terms of regulation CEI 64 8. a different use from the one specified in this booklet. 2. Components WHITENING LAMP 2 (REF 6910) Tool for build up: 1 allen key (hex tip screw driver) Safety Goggles according DIN EN 166:2002-04 (REF 5050) 4. 2. 3. 3. Installation 1. Attach the pole into the foot of the lamp. Fix with screw from below using the tool delivered with the lamp. 2. Attach lamp head: fully open screw and adjust the inner plastic parts to show a round opening. Insert ball of lamp handle and close the big screw handle again. 3. Plug small cables to connect the power supply on the head and the lift. Make sure to fit the plug into the notch. After fully injecting, turn the screw. 5. 1. Align connector on notch! 2. Fully insert connector 4. The exchangeable, autoclavable silicon part has to be fi xed on the lamp head. 5. Plug power cable in socket under the control box. 3. Close screw WARNING: to avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. 1. 7
4. Operation of user interface CONSTANT PULSE SINGLE Time adjustment 01:00 to 20:00 min Power selection (only for CONSTANT and SINGLE mode) I 25% - II 50% - III 75% - IIII 100% PAUSE START STOP 8 CONSTANT MODE All 3 LED constantly working. Light intensity can be adjusted in 4 levels. PULSE MODE The 3 LED are activated in a sequence. This mode has a high light intensity with low temperature increase. It is recommended as the standard procedure and also for sensitive patients. SINGLE MODE For single tooth whitening. Light intensity can be adjusted in 4 levels. Time adjustment Can be adjusted from 1:00 to 20:00 minutes. Power adjustment For CONSTANT and SINGLE mode the light intensity can be adjusted to 25% /50% /75% /100%. The higher the level the more temperature increase in the gel. Even at level IIII the system is always safe for your patients. START Pressing the START button the procedure begins and the LED's go on. PAUSE Pressing the PAUSE button holds the process and the time stays on the current value. STOP Pressing the STOP button ends the procedure and the lamp jumps back in the original setting. 9
5. Adjusting lamp head in front of patient The WHITENING LAMP 2 offers a lot of possibilities to adjust the head of the lamp in front of the patient mouth. The head can be moved in 3 dimensions. Additionally the angle of the holding arm of the head can be adjusted. As shown aside the lamp can be arranged in front of the patient s position, from the side and even from the back. WARNING: use light only if patient and operator wear PBX Safety Goggles. 166 cm 63 cm 142 cm 149 cm 10 6. Power supply control box located under user interface box 1. Double power supply switch with signals I for ON and 0 for OFF. 2. 100-240 V ~ 50 Hz 60 Hz VDE type fl oat socket). 3. Fuse located in power supply control box. Exchange fuse inside the box. Fuse specification are given on device identification sticker. 8. Troubleshooting In case of any unusual malfunction please contact your local dealer for help. 1. Lamp does not start Like any other electrical equipment the lamp has a fuse to protect from power peaks. In the power supply control box is a second fuse as back-up. In case that the lamp does not show anything on the screen, please exchange the fuse. 7. Whitening procedure operation of the lamp 1. Plug power cable in electrical outlet 100-240 V. 2. Switch on power. 3. Follow the instruction of the Whitening Gel manufacturer to apply the gel and for time per treatment cycle. 4. Bring lamp in a position that the blue part of the lamp head can be placed very close to the patients mouth. Special protection of lips or soft tissue is not necessary. 5. Make sure that patient and operator are wearing orange safety goggles according DIN EN 166:2002-04. 6. Adjust time following the instruction of the whitening gel manufacturer (usually about 10 15 minutes) and press start. Repeat for the recommended number of cycles. 2. Arm positioning is not accurate The screw on the joint of the lamp might be loose. Please close the screw slightly tighter. Do not close with pressure. 9. Cleaning Before cleaning the device, switch it off. The device can be cleaned with a soft cloth slightly moistened with nontoxic and non-flammable solvents: tested solvents available on the market are recommended. Avoid the entry of liquid into device components. Do not use strong solvents or sharp instruments. 10. Note Keep out of children s reach. To be used exclusively for oral cavities, as described in this explanatory sheet. The product may only be used in keeping with the specifi c instructions for use. WHITEsmile does not accept any responsibility for damage resulting from failure 11
WHITEsmile GmbH Weinheimer Strasse 6 69488 Birkenau Germany Signs and Symbols to comply with the instructions for use or for uses other than those foreseen by the field of application for the product. The user is responsible for experimenting with the material for uses not explicitly described in the instructions for use. The descriptions and date reported herein are approximate and not binding. The content of this user s manual is subject to variations. CE-Symbol 11. Warranty Serial Number See the user manual! Manufacturer Type B IPX 1 WHITEsmile or your local dealer will repair or at its option replace, without charge, your product which proves to be defective in material or workmanship under normal use, during the warranty period of 2 years from invoice date. Freight cost and compensation for absent device are not covered by the warranty. The above warranty does not cover damages or problems which result from misuse, abuse, accident, alteration, or incorrect use not in accordance with the manufacturer s instructions. WHITEsmile authorises the repairing of its devices to those laboratories with qualified personnel (electrical engineers) who shall receive the necessary information for repairing and testing the product. The testing equipment and spare parts shall be sent by request. Note: the repairing operation must follow the actual required standards. In case of breakdown of the apparatus contact your local dealer or: Switching on/off Special recycling (WEEE) WHITEsmile GmbH Weinheimer Strasse 6 69488 Birkenau Germany Phone: +49 6201 / 8 43 21-90 12 REF Article number No compensation could be demanded from the purchaser for the detention of the equipment. Declaration of Conformity Hersteller: WHITEsmile GmbH Weinheimer Straße 6 69488 Birkenau / Germany Product: Whitening Lamp 2, REF 6910 Classifi cation: Class I We hereby assure and declare that the products above are complying with the MDD 93 / 42 / EEC for Medical Devices. Start of labeling the CE-Mark: Lot-Nr. 01005 This declaration is valid until April 18th, 2014. City, Date: Birkenau, 19-04-2011 Signature: Benno Walter, Managing Director 13
Developed for / Entwickelt für: Ideal for Aftercare / Ideal zur Nachpflege: Light Whitening Gel Whitening Pen Whitening Toothpaste WHITEsmile 2011 Subject to technical changes and errors in the text. / Technische Änderungen und Irrtümer vorbehalten. Order No / Bestellnummer 145 Version 2.0 06/2011 MADE IN FRANCE WHITEsmile GmbH Weinheimer Straße 6 69488 Birkenau Germany Fon +49 (0)62 01 / 8 43 21 90 Fax +49 (0)62 01 / 8 43 21 99 E-Mail: info@whitesmile.com Internet: www.whitesmile.com