Contents 1 Product introduction..................................................................................3 2 Installation ..............................................................................................12 3 Function and operation of product...........................................................15 4 Operation instruction...............................................................................18 5 Troubleshooting..................................................................
1 Product introduction 1.1 Preface Guilin Woodpecker Medical Instrument Co., Ltd is a professional manufacturer researching, developing, and producing dental products. Woodpecker owns a sound quality control system. Guilin Woodpecker Medical Instrument Co., Ltd has two brands, Woodpecker and DTE. Its main products include Ultrasonic Scaler, Curing light, Apex locator, Ultrasurgery, Endo 3 Motor, etc. 1.
traditional pneumatic low-speed handpiece, it enables more stable polishing and better treatment. c) One-button speed control d) Wireless foot control (optional) enables convenient treatment. 1.3 Model and specification i-Polish Please refer to the packing list for device configurations. 1.4 Performance and composition 4 The device is composed of motor component, outer Sheath, charging station, power adapter, foot control (optional), disposable silicon sleeve.
i-Polish 5 1.5 Scope of application 1.5.1 It is mainly used for teeth cleaning and polishing.
1.5.2 The device must be operated in hospital and clinic by the qualified dentists. 1.6 Contraindication a) Doctors with a pacemaker are prohibited from using this device. b) Patients with a pacemaker (or other electrical equipment) who are warned not to use small appliances (such as Electric razors, hair dryers, etc.) are prohibited from using this device. c) Hemophilia patients are prohibited from using this device.
1.7.4 This device requires special precautions regarding electromagnetic compatibility (EMC) and must be in strict accordance with the EMC information for installation and use. Do not use this equipment near the fluorescent lamps, radio transmitting devices, remote control devices, handheld and mobile high-frequency communication devices. 1.7.5 Long term use of equipment may result in overheat of motor handpiece, thus it should be left to cool for next use.
1.7.9 The component, charging base, power adapter, and foot control cannot be autoclaved. Use disinfectant of neutral pH value or ethyl alcohol to wipe its surface. 1.7.10 Before the motor component stop rotating, do not install or remove the outer sheath. Otherwise the motor component may be damaged. 1.7.11 Before the motor component stop rotating, do not remove the disposable prophy angle. Otherwise the disposable prophy angle and the handpiece will be damaged. 8 1.7.
temperature of the charging base and motor handpiece will rise. It is recommended that the time of contacting motor handpiece and charging base during wireless charging should not exceed 10 seconds. 1.7.16 The device not intended to be used in areas where liquids are likely to be present at floor level, such as emergency rooms or operating theatres. 1.7.
1.8.3 Degree of protection against electric shock: B type applied part 1.8.4 Degree of protection against harmful ingress of water: Handpiece Foot control Charging base Power adapter IPX3 IPX1 IPX0 1.8.5 Degree of safety application in the presence of a 10 flammable anesthetic mixture with air, oxygen, or nitrous oxide: Equipment cannot be used in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. 1.8.6 Applied part : Disposable prophy angles. 1.8.
Input: ~100V-240V 50Hz/60Hz 0.5-0.2A Output:DC5V/1A 1.9.3 Speed range: 500rpm~4000rpm 1.9.4 Wireless charging Frequency range: 112-205 KHz Maximum RF output power of the product: 9.46dBuA/ m@3m 1.10 Environment parameters 1.10.1 Environment temperature: +5℃ ~ +40℃ 1.10.2 Relative humidity: 30% ~ 75% 1.10.
2 Installation 2.
2.2 Instructions for Disposable Barrier 2.2.1 Before installing disposable barrier, please make sure that the motor handpiece is fully charged. If it is of low battery level, please first charging the device. 2.2.2 Insert the motor component into the disposable barrier. Warnings: Before installation, please check whether the disposable barrier is intact. If it is damaged, please do not use it. 13 2.3 Instructions for Outer Sheath 2.3.
2.4 Instructions for Disposable Prophy Angle 2.4.1 Install the Disposable Prophy Angle into the cordless handpiece. Warnings: a) Please use the Disposable Prophy Angle fitting this device. Otherwise the Disposable Prophy Angle and the motor handpiece will be damaged. b) Before installing the Disposable Prophy Angle, please 14 ensure the motor handpiece was stopped.
3 Function and operation of product 3.1 Button definition and settings 15 3.1.1 Turn power on Press Main Button to turn on the handpiece. 3.1.2 Turn power off Hold down the Main button to turn off the handpiece. 3.1.3 Handpiece speed setting With the handpiece turned on, press Main button to adjust the speed mode.
When switching to this mode, it is controlled by wireless foot control by default Low speed mode 500rpm Medium speed mode 1500rpm High speed mode 3000rpm Super high speed mode 4000rpm Foot control mode 16 3.2 Function and operation of foot control 3.2.1 Activate the foot control After the pedal is used for the first time or placed for a long time, you need to press the pedal for 3 seconds to activate the pedal.
When the pedal is stepped on, if the wireless connection indicator flashes, it indicates that the pedal is not connected to the handpiece. When the pedal is stepped on, if the wireless connection indicator light is always on, it indicates that the pedal and the handpiece are connected. When the power indicator shows yellow, it means the pedal has a low battery and needs to be charged. When the power indicator flashes, it means that the battery power is extremely low.
4 Operation instruction 4.1 Power on Quickly press the button on the installed handpiece to start the handpiece. When the power indicator of the handpiece is on, it means the handpiece is turned on. 4.2 Load polishing paste Adjust the handpiece to pedal mode or low speed mode, and then load the polishing paste to the Disposable Prophy Angle. 18 4.3 Treatment Use the handpiece buttons or the foot control to adjust to a proper speed, and then start the treatment. 4.
instructions), and discard the disposable barrier and Disposable Prophy Angle as medical waste. 4.5 Charging instruction 4.5.1 Charging of handpiece Connect the original power adapter to the base, plug it into a suitable socket, and place the handpiece into the base for charging. When charging, the charging indicator of the base will flash regularly, and the indicator light will turn on when it is fully charged. 19 4.5.
5 Troubleshooting Failure Solutions Disposable Prophy 1. Ensure that the outer sheath and the Angle is not rotating Disposable Prophy Angle are snapped together securely. 2. Ensure that the Motor Component and the outer sheath are snapped together securely. 20 3. Ensure the Disposable Prophy Angle is not damaged. 4. Ensure the outer sheath is not damaged.
Excessive noise or 1. Ensure that the outer sheath and the vibration Disposable Prophy Angle are snapped during operation together securely. 2. Ensure that the Motor Component and the outer sheath are snapped together securely. 3. Ensure the Disposable Prophy Angle is not damaged. 4. Ensure the outer sheath is not damaged. 21 Difficult to removing 1. Ensure the outer sheath is not damaged. or installing the 2. Check and clean the outer sheath. outer sheath. Motor Component 1.
6 Cleaning, Disinfection and Sterilization 6.1 Foreword For hygiene and sanitary safety purposes, the outer sheath must be cleaned, disinfected and sterilized before each usage to prevent any contamination. This concerns the first use, as well as all subsequent uses. 6.2 General recommendations 6.2.1 Use only a disinfecting solution which is approved for 22 its efficacy (VAH/DGHM-listing, CE marking, FDA and Health Canada approval) and in accordance with the DFU of the disinfecting solution manufacturer. 6.
6.2.6 The user is responsible for the sterility of the product for the first cycle and each further usage as well as for the usage of damaged or dirty instruments where applicable after sterility. 6.2.7 The water quality has to be convenient to the local regulations especially for the last rinsing step or with a washerdisinfector. 6.
steps are as follows: Warnings: the motor component, power adapter and charging base cannot be cleaned and disinfected with automatic equipment. Manual cleaning and disinfection is required. 6.3.1.1 Manual cleaning steps: 1. Take out the motor component, power adapter and charging base on the workbench. 2. Wet the soft cloth completely with distilled water or deionized 24 water, and then wipe all the surfaces of the components such as the motor component, power adapter and charging base, etc.
1. Soak the dry soft cloth with 75%alcohol. 2. Wipe all surfaces of the motor component, power adapter, charging base and other components with a wet soft cloth for at least 3minutes. 3. Wipe the surface of the component with a dry soft nap-free cloth. Note: a) The cleaning and disinfection must be performed within 10min before use. 25 b) The disinfectant used must be used immediately, no foaming is allowed.
steps, see section 2.*). 6.3.2 Post-Op processing After each use, clean and disinfect the motor component, power adapter and charging base within 30 minutes. The specific steps are as follows: Tools: Nap-free soft cloth, tray 1. Remove the outer sheath from the motor component, place it in a clean tray, and then remove the disposable barrier from the motor component. 26 2.
Note: a) The cleaning and disinfection must be performed within 10min before use. b) The disinfectant used must be used immediately, no foaming is allowed. c) In addition to 75% alcohol, you can use non-residue disinfectants such as Oxytech from Germany, but you must respect the concentration, temperature and time specified by the disinfectant manufacturer. 27 6.4 The cleaning, disinfection and sterilization of Outer Sheath Unless otherwise stated, they will be hereinafter referred to as “products”.
Processing limit The products have been designed for a large number of sterilization cycles. The materials used in manufacture were selected accordingly. However with every renewed preparation for use, thermal and chemical stresses will result in ageing of the products. The maximum number of sterilizations for products is 250 times. 6.4.1 Initial processing 6.4.1.1 Processing principles 28 It is only possible to carry out effective sterilization after the completion of effective cleaning and disinfection.
clinic, especially with regard to the additional requirements for the inactivation of prions. 6.4.1.2 Post-operative treatment The post-operative treatment must be carried out immediately, no later than 30 minutes after the completion of the operation. The steps are as follows: 1. Remove the products from the base, and rinse away the dirt on the surfaceofhandpiecewithpurewater(ordistilledwater/ deionizedwater); 29 2. Dry the products with a clean, soft cloth and place it in a clean tray.
them into a clean tray; 2. Use a clean soft brush to carefully brush outer sheath, head and back cover of the outer sheath until the dirt on surface is not visible. Then use soft cloth to dry the products and put them into a clean tray. The cleaning agent can be pure water, distilled water or deionized water. 3. Disassembling steps a) Remove the disposable prophy angle. b) Remove the outer sheath from the handpiece. 30 6.4.
• There should be a flushing connector connected to the inner cavity of the product. • The cleaning procedure is suitable for the product, and the irrigating period is sufficient. It is recommended to use a washer-disinfector in accordance with EN ISO 15883. For the specific procedure, please refer to the automated disinfection section in the next section "Disinfection". Notes: a) The cleaning agent does not have to be pure water. It can be distilled water, deionized water or multi-enzyme.
6.4.4 Disinfection Disinfection must be performed no later than 2 hours after the cleaning phase. Automated disinfection is preferred if conditions permit. 6.4.4.1 Automated disinfection-Washer-disinfector • The washer-disinfector is proved to be valid by CE certification in accordance with EN ISO 15883. • Use high temperature disinfection function. The temperature does not exceed 134℃ , and the disinfection under the 32 temperature cannot exceed 20 minutes.
water lines to the rinsing connection of the washer-disinfector. 3. Start the program. 4. After the program is finished, remove the product from the washer- disinfector, inspect (refer to section "Inspection and Maintenance") and packaging (refer to chapter "Packaging"). Dry the product repeatedly if necessary (refer to section "Drying").
is difficult to remove. (c3) The solution used can be pure water, distilled water, deionized water or multi-enzyme solution, etc., and only freshly prepared solutions can be used. (c4) During the use of cleaner, the concentration and time provided by manufacturer shall be obeyed. The used cleaner is neodisher MediZym (Dr. Weigert).
h) Regularly repair and inspect the disinfector. 6.4.5 Drying If your cleaning and disinfection process does not have an automatic drying function, dry it after cleaning and disinfection. Methods: 1. Spread a clean white paper (white cloth) on the flat table, point the product against the white paper (white cloth), and then dry the product with filtered dry compressed air (maximum pressure 3 bar). Until no liquid is sprayed onto the white paper 35 (white cloth), the product drying is completed. 2.
6.4.6 Inspection and maintenance 6.4.6.1 Inspection In this chapter, we only check the appearance of the product. 1. Check the product. If there is still visible stain on the product after cleaning/disinfection, the entire cleaning/disinfection process must be repeated. 2. Check the product. If it is obviously damaged, smashed, detached, corroded or bent, it must be scrapped and not allowed to continue to be used. 36 3. Check the product.
Notes: a) The package used conforms to ISO11607; b) It can withstand high temperature of 138℃ and has sufficient steam permeability; c) The packaging environment and related tools must be cleaned regularly to ensure cleanliness and prevent the introduction of contaminants; d) Avoid contact with parts of different metals when packaging. 6.4.
Verificationofthefundamentalsuitabilityoftheproductsforeffective steam sterilization was provided by a verified testing laboratory. Notes: a) Only products that have been effectively cleaned and disinfected are allowed to be sterilized. b) Before using the sterilizer for sterilization, read the Instruction Manual provided by the equipment manufacturer and follow the instructions. c) Do not use hot air sterilization and radiation sterilization as 38 this may result in damage to the product.
* Fractional pre-vacuum procedure = steam sterilization with repetitive pre-vacuum. The procedure used here is to perform steam sterilization through three pre-vacuums. 6.4.9 Storage 1. Store in a clean, dry, ventilated, non-corrosive atmosphere with a relative humidity of 10% to 93%, an atmospheric pressure of 70KPa to 106KPa, and a temperature of -20℃ to +55℃ ; 2.
2. It should not be mixed with dangerous goods during transportation. 3. Avoid exposure to sun or rain or snow during transportation. 7 Storage, maintenance and transportation 7.1 Storage 7.1.1 This equipment should be stored in a room where the relative humidity is 10% ~ 93%, atmospheric pressure is 70kPa 40 to106kPa, and the temperature is -20℃ ~ +55℃ . 7.1.2 Avoid the storage in a too hot condition.
authorized after service center. 7.2.2 Keep the equipment in a dry storage condition. 7.2.3 Do not throw, beat or shock the equipment. 7.2.4 Do not smear the equipment with pigments. 7.2.5 Calibration is recommended when using a new/other contra angle or after an extend period of operation, as the running properties can change with usage, cleaning and sterilization. 7.2.6 Replace the battery if it seems to be running out of power 41 sooner than it should. 7.3 Transportation 7.3.
8 Environmental protection Please dispose according to the local laws. 9 After-sales service 42 From the date this equipment has been sold, based on the warranty card, we will repair this equipment free of charge if there are quality problems. Please refer to the warranty card for the warranty period.
Date of manufacture Type B applied part Manufacturer Class II equipment Used indoor only Recovery Handle with care Keep dry CE marked product Humidity limitation Appliance compliance WEEE directive Protection Class IPX0 - IPX0 Classification of ingress of water for Charging Station – not protected Protection Class IPX1 - IPX0 Classification of ingress of water for foot control.
Protection Class IPX3 - IPX3 Classification of ingress of water for Motor Component - Protected against falling spray. Temperature limitation Atmospheric pressure for storage 44 Authorized Representative in the EUROPEAN COMMUNITY 12 Statement All rights of modifying the product are reserved to the manufacturer without further notice. The pictures are only for reference. The final interpretation rights belong to GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
13 EMC-Declaration of conformity The device has been tested and homologated in accordance with EN 60601-1-2 for EMC. This does not guarantee in any way that this device will not be affected by electromagnetic interference Avoid using the device in high electromagnetic environment.
RF emissions CISPR 11 Group 1 RF emissions Class B CISPR11 Harmonic emissions Class A 46 lEC 61000-3-2 Voltage fluctuations/ flicker Complies emissions lEC 61000-3-3 The model i-Polish uses RF energy Only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
The model i-Polish is intended for use in the electromagnetic environment specified below. The customer or the user of the model i-Polish should assure that It is used in such an environment. Electromagnetic Immunity IEC 60601 Compliance level environment test test level guidance Floors should be wood, concrete or ceramic tile.
Electrical fast transient/ burst IEC 61000-4-4 Surge IEC 6100048 4-5 ±2kV for power supply lines ±1kV for Input/ output lines ±2kV for power supply lines ±0.5, ±1kV line to line ±0.5, ±1, ±2kV line to earth ±0.5, ±1kV line to line ±0.5, ±1, ±2kV line to earth Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 610004-11 <5 % UT (>95% dip in UT.) for 0.5 cycle <5 % UT (>95% dip in UT.) for 1 cycle 70% UT (30% dip in UT) for 25 cycles <5% UT (>95 % dip in UT) for 250 cycles <5 % UT (>95% dip in UT.) for 0.5 cycle <5 % UT (>95% dip in UT.) for 1 cycle 70% UT (30% dip in UT) for 25 cycles <5% UT (>95 % dip in UT) for 250 cycles Mains power quality should be that of a typical commercial or hospital environment.
Power frequency magnetic fields should be at levels characteristic of a 30A/m 30A/m typical location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level.
Conducted RF lEC610004-6 Conducted RF lEC610004-6 Radiated RF lEC610004-3 3 Vrms 150 kHz to 80 MHz 6 Vrms ISM 3V frequency 6V band 3V/m 3 V/m 80 MHz to2.7 GHz Portable and mobile RF communications equipment should be used no closer to any part of the models i-Polish, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d=1.2×P1/2 d=2×P1/2 d=1.2×P1/2 80 MHz to 800MHz d=2.3×P1/2 800 MHz to 2.
NOTE 1 At 80 MHz and 800 MHz. the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Fieldstrengthsfromfixedtransmitters,suchasbasebasesforradio(cellul ar/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
Recommended separation distances between portable and mobile RF communications equipment and the model i-Polish The model i-Polish is intended for use in electromagnetic environment in which radiated RF disturbances is controlled.
10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) accordable to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz. the separation distance for the higher frequency range applies. 54 NOTE 2 These guidelines may not apply in all situations.
undesired operation. This device has been tested and found to comply with the limits for a WPC device, pursuant to Part 18 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: -- Reorient or relocate the receiving antenna.
ZMN-SM-295 V1.
