www.glwoodpecker.com W Dre. =X ULTRASONIC SCALER INSTRUCTION MANUAL FDA CE (Please read this manual before operating) GUILIN WOODPECKER MEDICAL INSTRUMENT CO.,LTD.Contents 1 The installation and components of equipment 1 1.1 Lasteaetiox—_i@ ——#@——__!_H__—_—_———]1 1.2. Components $$ 1,3 The main technical specifications 4-H} 1.4 Installation of the main components 3 2, Product function and operation-—H4H4HH-+_5 2.1 Operation-@$@ —@ AAA 5 2.2 Instruction for main components of detachable handpiece 7 2.3 Torque wrench instruction --— 444447 3. Sterilization and maintenance HWY —_8 3.1 Sterilization of detachable handpiece ———________________8 3.2 Sterilization of scaling tips HH _—_4H4#—8 3.3 Sterilization of torque wrench— ——H4H4H-H+—_9 3.4 Cleaning of tips, and torque wreach——H-+—_____-_9 3.5 Sterilization and cleaning of LED lamp and Light pipe —————____9 3.6 Troubleshooting and notes 9 4, Precautions £@ —-@—-___—Y__—_ 12 4.1 Notice when using equipment—H4H4HH-—-——__—12 4,2 Contraindication—@4@£ cc 13 4.3 Storage and maintenance 14 4.4 Transportation @@ $2 WH 14 4.5 Working condition OO @$ OO ——____—_14 $8. AB er. sery§¢—@—£O+$$@$@ i 4 6. Symbol instruction $15 7. Environmental protection ———______________16 8. Manufacturer’s right——______________16 9. For technical data, please contact 16 10. Declaration of conformity HHH ____ 16 10.1 Product conformity the following standards 16 10.2 EMC - Declaration of conformity 2 2 tHt———————_17 1, Statement-£@@-—-——WHHWH———20The installation and components of equipment 1.1 Instruction Guilin Woodpecker Medical Instrument Co., Ltd. is a professional manufacturer in researching, developing and producing ultrasonic scalers. The product is mainly used for teeth cleaning and is also an indispensable equipment for teeth disease prevention and treatment. The product D3 LED ultrasonic scaler has scaling, perio functions. It contains the following features: 1.1.1 Optical handpiece, more convenient for clinical operation. 1.1.2 Automatic frequency tracking ensures that the machine always works on the best frequency and performs more steadily. 1.1.3 The handpiece is detachable and can be autoclaved to the high temperature of 135°Cand the pressure of 0.22MPa. 1.1.4 Digitally controlled, easy operation and more efficient for scaling. These features make D3 LED become a new generation product in the world dental market, 41.2 Components 1.2.1 The components of the machine are listed in the packing list. 1.2.2 Product performance and structure Ultrasonic scaler is composed of clectrocircuit, water way and ultrasonic transducer. 1.2.3 Scope of application Ultrasonic scaler D3 LED is used for the dental calculus climination. “ 2 ificati 1.3.1 Power supply Input: 220-240V~ 50Hz/60Hz 150mA. 1.3.2 Main unit input: 24V~ 50Hz/60Hz 13A 1.3.3 Output primary tip Vibration excursion: <100um_ 1.3.4 Output half-excursion force: <2N 1.3.5 Output tip Vibration frequency: 28kHz!3kHz1.3.6 Output power: 3W to 20W 1.3.7 Main unit fuse: TI6AL 250V 1.3.8 Power supply fuse: TO.5AL 250V 1.3.9 Water pressure: 0.Ibar to Sbar (0.01MPa to 0.5MPa) 1.3.10 Weight of main unit: 0.66kg 1.3.11 Weight of power supply:1 kg 1.3.12 Main unit volume: 198mm*134mmx80mm 1.3.13 Operating mode: Continuous operation 1.3.14 Type of protection against electric shock: Class II equipment 1.3.15 Degree of protection against electric shock: Type BF applied part 1.3.16 Degree of protection against harmful ingress of water: Ordinary equipment (IPX0). Protection degree against water (used on foot switch); IPX1 1.3.17 Applied part of the equipment: handpiece and tip 1.3.18 Degree of safety of application in the presence of a Flammable Anesthetic Mixture with air or with Oxygen or Nitrous Oxide: Equipment not suitable for being used in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide14 Installati in. nts 1.4.1 Sketch map for installation and connection a) The components of the equipment Scaling indicator ore] se Option switch 4 a = Power indicator erin indicator Increasing power switch Decreasing power switch Water control knob Socket for 3 foot switch =~ oS Power switch Water entrance Socket for power supply Picture 1b) Sketch map for connection of foot switch, power supply and main unit Plug of foot mit ‘Foot switch Sate ) = CZ y Plug of C }* a foot switch /Foot switch socket supply Input voltage 220-240V~ Power cord plug Wy + —& Power cord plug/ Socket for power supply Picture 2 6) Sketch map for connection of water supply system Connect pure water ip of connector 2 eS Water pipe => ‘ ey ( 5 ee © ‘ wer _, Water entrance Picture 3d) Sketch map for connection of dctnchable handpiece [ DTE. wr & Céou -| [_ LED lamp Handpiece Cable @o @ oe-q==p bio Nipple Light pipe Hane eo point The connector of cable Picture 4 e) Sketch map for how to install tip with wrench 2, Product function and operation 21 ion 2.1.1 Open the packing box, make sure that all the parts and accessories are complete according to the packing list. Take the main unit out of the box and put it ona stable plane. 2.1.2 Tum the water control switch to the max based on symbol as shown as 3.5.2 [note I]. 2.1.3 Insert the plug of the foot switch to its socket (picture 2). 2.1.4 Connect one end of the water pipe to the water entrance, and the other endto the pure water source (picture 3). 2.1.5 Screw the scaling tip tightly to handpiece by torque wrench, then connect the handpiece and the connector of cable correctly. 2.1.6 Insert the plug of the power supply to its socket, then get through to the power (picture 2). 2.1.7 Switch on the main unit, then the scaling indicator and the first five lights of power regulator shine. 2.1.8 Step on the foot switch, the tip begins to vibrate, and the LED lamp on the top of the handpiece shines. Release the foot switch, the LED lamp keep shining for 10 seconds. 2.1.9 Select a suitable scaling tip as you need, screw it on the handpiece tightly by the torque wrench (picture 5). 2.1.10 The normal frequency is extremely high. Under the normal working state of scaling tips, a light touch and a certain to-and-fro motion will eliminate the tartar without heating, Overexertion and long-time lingering are forbidden. 2.1.11 Vibrating intensity: Adjust the vibration intensity as you need, generally tum the knob to the middle grade. According to paticnts different sensitivity and the rigidity of the gingival tartar, adjust the vibration intensity during the clinical treatment. 2.1.12 Water volume adjustment: Step on the foot switch, and the tip begins to vibrate, then turn the water control switch to fine spray to cool down the handpiece and clean the teeth. 2.1.13 The handpiece can be handled in the same gesture as a pen in hand. 2.1.14 During the clinical treatment, be sure not to make the end of tip touch the tecth vertically and not to make the tip overexert on the surface of the teeth in case of hurting the teeth and damaging the tip. 2.1.15 After finishing operation, keep the machine working for 30 seconds on the water supply condition in order to clean the handpiece and the scaling tip. 2.1.16 Unscrew the scaling tip and pull out handpiece, then sterilize them. Notice: Don't pull out the handpiece when the foot switch is stepped on and the machine is working.2.2 Instruction for main components of detachable handpiece (showed in picture 4) a) Nipple: The nipple can be removed. You can screw off the nipple and clean the pole with alcohol termly. b) Decorative ring: can be disassembled and cleaned with alcohol regularly, can be autoclaved under the high temperature and pressure. c) Handpiece: The main part of the whole handpiece, can be autoclaved under the high temperature and pressure. d) The comnector of the cable: Comnect the handpiece with the water source and power supply of the main unit. ©) LED lamp, Light pipe: Clean them with purified water and sterilize them under the high temperature of 135°C and high pressure of 0.22Mpa. Notice: Keep connector dry. 2.3 Torque wrench instruction (showed in picture 5) 2.3.1 The torque wrench's structure is designed in special way which can control the strength of the scaling tip's installation properly and correctly. It also can guarantee the operator screw or unscrew the scaling tip effectively and keep their hands away from being scratched. 2.3.2 Operation a) Take the scaling tip into the torque wrench; operate as showed in picture 5. b) Tip installation: Hold the handpiece, turn the tip toward direction as showed in picture 5 with the torque wrench. Turn two more circles when the tip stops, then the tip is installed. c) Tip uninstallation: Hold the handpiece, turn the wrench toward anti-clockwise direction. d) Sterilize it in sterilizer after each treatment. ¢) The torque wrench must be cooled naturally after sterilization to avoid scalding when using next time. f) Keep the torque wrench in a cool, dry and ventilated place and keep it clean. 2.3.3 Precaution The following sterilizing methods are forbidden. a) Braise in liquor;b) Dip in iodine, alcohol or glutaraldehyde; ©) Torrefy in oven or microwave oven. Notice: we are not responsible for any damage of the torque wrench directly or indirectly made by any way in the above items. 3. Sterilization and maintenance 4,1 Sterilization of detachabl dpi 3.1.1 Autoclaved to high temperature/pressure: a) 121°C/1 bar (0.IMPa). b) 135°C/2.2bar (0.22MPa). ¢) Pull out the handpiece and unscrew the scaling tip after each operation. d) Pack the handpiece with sterile gauze or sterile bag before sterilizing. €) Reuse handpiece after it cools naturally in case of scalding hand. 3.1.2 Notice a) Clear the cleaning liquid on the handpicce with compressed air before sterilization. ‘b) Be sure that the scaling tip has been unscrewed from the handpiece and it can not be sterilized with others, c) Please notice whether the outer of the handpiece is damaged during the treatment or sterilization, don't smear any protective oil on the surface of handpiece. d) There are two waterproof "O" rings at the end of handpiece. Please lubricate them with dental lube frequently, as sterilization and repeated pulling and inserting will reduce their life-span. Change a new onc once it is damaged or worn excessively. ¢) The following sterilizing methods are forbidden: @ Put handpiece into any liquid for boiling. @ Put handpiece into disinfectors such as iodine, alcohol and glutaraldehyde. @ Put handpiece into oven or microwave oven for baking. ilization of scaling tij All the scaling tips can be autoclaved to 135°C. 83.3 Sterilization of torque wrench 3.3.1 The torque wrench can be sterilized under high temperature and pressure. 3.3.2 The following sterilization ways for torque wrench are forbidden: a) Braise in liquor. b) Dip in iodine, alcohol or glutaraldehyde. ¢) Torrefy in oven or microwave oven. Notice: We are not responsible for any damage of the torque wrench directly or indirectly made by any way in the above items. 3.4 Cleaning of ti i 4 The scaling tip, torque wrench can be cleaned by ultrasonic cleaner. Steri ED and Light pipe Clean the LED lamp and Light pipe with purified water and sterilize them under high temperature and high pressure after every operation. 3.6 Troubleshooting and notes 3.6.1 TroubleshootingFault Possible causes Solutions [The power pipe plug isin |Connect the power plug IThe scaling tip doesn’t |1oose contact. well. vibrate and there isno |The foot switch is in loose [Insert the foot switch to its [water flowing out when |contact. socket ti I. stepping on the foot The fuse of transformer is |Contact our dealers or us. switch. |broken. The fuse in the main unit is |Contact our dealers or us. lbroken. |The scaling tip doesn’t |The tip is in loose contact. |Screw the tip on the |vibrate but there is jiece tightly, (pictures |water flowing out when |The connect plug between |Contact our dealers or us. stepping on the foot _|the handpiece and the switch. circuit board is in loose contact. Something wrong with the |Scnd it to our company to |handpiece. repair. Something wrong with the |Contact our dealers or us. cable, The water control switch is |Turn on the water control [not on. switch. [note 1] |The scaling tip vibrates |There is impurity in the |Contact our dealers or us. but there is no spay jelectric-magnetic valve. [when stepping on the | The water system is (Clean the water line by switch. blocked. multi-function syringe. [note 2] |There is still water There is impurity in the |Contact our dealers or us. lowing out after the _|electric-magnetic valve. 10Possible causes |The amount of spouting water is too little. |The water control switch is |Turn the water control |The vibration of the tip [becomes weak. The coupling between the [Dry it by the hot air. handpiece and the cable ‘isn’t dry. The tip is damaged . [ note3 } |There is water seeping |The waterproof “O” ring is |Change a new "O" ring. from the coupling damaged. [between the handpiece jand the cable. If the problem still can't be solved, please contact with local dealer or manufacturer. 3.6.2 Notes a)[Note I] The water control knob can adjust the water volume according to the symbol b)[Note 2] Clean the water pipe with the multi-function syringe of the dental unit (as showed in picture 6): alMulti-function syringe Picture 6 @ Cut the water pipe at a distance of 10cm to 20cm from the water entrance @ Tum on the electricity and get through to the electricity. © Connect the Multi-function syringe of dental unit to the water pipe. @Disassemble the tip or handpiece. @®Step on the foot switch. @©Turn on the switch of the Multi-function syringe, press the water into the machine and the impurity blocked in the water pipe can be eliminated. c)[Note 3] If the scaling tip has been screwed on tightly and there is fine spray too, the following phenomena show that the scaling tip is damaged: ©The vibrating intensity and the water atomization degree become weak obviously. @®During treatment, it produces the sound like "buzz" from the scaling tip 4. Precaution LNotice wh : . 4.1.1 Keep the scaler clean before and after operation. 4.1.2 The handpiece, scaling tip, torque wrench, must be. sterilized before every treatment. 4.1.3 Don't screw the handpiece, scaling tip when stepping on the foot switch. 4.1.4 The scaling tip must be fastened and there must be fine spray or drip coming out from the tip when operating. 4.1.5 Change a new one when the tip and ultrasonic file are damaged or worn 12excessively. 4.1.6 While scaler working ,the heat of scaling tip will become higher if there is no water flowing out.Please keep the water flow smoothly. 4.1.7 Don't twist or rub the tip. 4.1.8 Don't use impure water source and be sure not use normal brine instead of pure water source. 4.1.9 If use the water source without pressure, the water surface should be one meter higher than the head of the patient. 4.1.10 Keep the connector of handpiece and the socket of the cable dry before installing the handpiece. 4.1.11 Don't pull the cable forcibly in case of the handpiece falling off from the cable. 4.1.12 Don't knock or rub the handpiece. 4.1.13 Please put the power plug into the socket easy to pull out, to make sure it can be pull out in emergency. 4.1.14 The power supply is considered as a part of ME equipment. This device can only be equipped with the special power supply of Guilin Woodpecker Medical Instrument Co., Lid. 4.1.15 The power supply is NOT waterproof. Please keep it dry and away from the water. 4.1.16 After operating, turn off power, then pull out the plug. 4.1.17 We are only responsible for the safety on the following conditions: a) The maintenance, repair and modification are made by the manufacturer of the authorized dealer. b) The changed components are original of ‘DTE” and operated according to instruction manual. 4.1.18 The internal screw thread of the scaling tips produced by some manuf- acturers maybe coarse, rusty and collapsed. This will damage the external screw thread of the handpiece irretrievably. Please use "DTE" brand scaling tips. 4.1.19 Please select a suitable power when using different type of tips (refer to “TABLE OF OPERATING POWER OF THE TIPS"). 4.2 Contraindication 134.2.1 The hemophilia disease patient is not allowed to use this equipment. 4,2.2 The patients or doctors with heart pacemaker are forbidden to use this equipment. 4.2.3 The heart disease patient, pregnant woman and children should be cautious to use the equipment. 4.3 Storage and maintenance 4.3.1 The equipment should be handled carefully and lightly. Be sure that it is far from the vibration, and is installed or kept in a cool, dry and ventilated place. 4.3.2 Don't store the machine together with the articles that are combustible, caustic, or explosive. 4.3.3 This equipment should be stored in a room where the relative humidity is 80%, atmospheric pressure is 50kPa to 106kPa, and the temperature is 10°C to +50. 4.3.4 If the machine is not used for a long time, please make it get through the power and water once per month for five minutes, 4.4 Transportation 4.4.1 Excessive impact and shake should be prevented in transportation. Lay it carefully and lightly and don't invert it. 4.4.2 Don't put it together with dangerous goods during transportation. 4.4.3 Avoid solarization and getting wet in rain or snow during transportation. 5 Worki dit a) Environment temperature: 5’Cto 40°C b) Relative humidity: <80% c) Atmosphere pressure: 70kPa to 106kPa 5. After service We offer one year's free repair to the equipment according to the warranty card. The repair of the equipment should be carried out by our professional technician. We are not responsible for any irretrievable damage caused by the non- professional person. 146. Symbol instruction DTE. 0.01MPa-0.5MPa. Trademark (tT Used indoor only Date of manufacture a“ Alternating current Manufacturer ~24V — 24VAC power supply socket Class II equipment >» Connection for the foot switch Type BF applied part q@—H:0 Adjustment for the water flow Temperature limitation Can be autoclaved Humidity limitation Cc € 0197 CE marked product Atmospheric: pressure | Pg YAQ FDA marked product for storage o4 e Handle with care ctu i eal Recovery Consult the accompanying documents Appliance compliance WEEE directive ‘Water entrance pressure 0.01MPa-0.5MPa Authorised Representative in the EUROPEAN COMMUNITY 7. Environmental protection There are no harmful factors in our product, You can deal with it based on the local law. 158. Manufacturer’s right We reserve the right to change the design of the equipment, the technique, fittings, the instruction mamual and the content of the original packing list at any time without notice. If there are some differences between blueprint and real equipment, take the real equipment as the norm. 9. For technical data , please contact Wellkang Ltd (www.CE-Marking.eu) 29 Harley St. LONDON,W1G 9QR,UK 10. Declaration of conformity EN 60601-1:2006 EN 60601-1-2:2007 EN 60601-1-6:2010 EN 62366:2008 EN 61205:1994 EN ISO 22374:2005 EN 62304:2006 EN 980:2008 EN ISO 9687:1995 EN 1041:2008 ISO 15223-1-2012 EN ISO 14971:2012 EN ISO 7405:2008 +A1:2003 EN ISO 17664:2004 EN ISO 17665-1:2006 EN ISO 10993-1:2009 EN ISO 10993-5:2009 EN ISO 10993-10:2010 10.2 EMC - Declaration of conformity 16Guidance and manufacturers declaration - electromagnetic emissions: ‘The model UDS-~J, UDS-K, UDS-K LED, UDS-, UDS-L LED, UDS-A, UDS-ALED, UDS-P, UDS-E, UDS-P LED, UDS-E LED, 1, D3, D5, 07, 03 LED, DS LED, D7 LED are Intended for use In the electromagnetic environment specified below. The customer or the user of the model UDS-J, UDS-, UDS-K LED, UDS-L, UDS-L LED, UDS.A, UDS-ALED, UDS-P, UDS-£, UDS-P LED, UDS-E LED, D1 D3, DS, D7, Da LED, D6 LED, Emissions test__[ Compliance LED should assure th: in such an nent Electromagnetic environment - guidance RF emissions ‘The models UDS-J, UDS-K, UDS-K LED, UDS1L, UDS-L LED, UDS-A, UDS-A LED, UDS-P, UDS-E, UDS-P LED, UDS-E LED, Group | D1, D3, D5, D7, DSLED, DS LED, D7 LED use RF energy only for ‘CISPR 11 its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment ciseatt Clase 8 | The modes! UDS-, UDS-K, UDS-K LED, UDS4, UDG LED, ‘Harmonic emissions: UDS-A, UDS-A LED, UDS-P, UDS-E, UDS-P LED, UDS-E LED, IEC 61000-3-2 Class A D1, D3, D5, D7, D3 LED, DS LED, D7 LED are suitable for used in domestic establishment and in establishment directly connected to a low voltage power supply network which supplies buildings used ‘Clagett for domestic purposes, ‘ fioker emiesions ‘Complies IEC 61000-3-3 17