Vulcan - DMC Equipamentos
Contents
1. Sau ong E l BEE Vulcan User Manual x Vulcan is a device manufactured with the latest technology and all devices is tested individually The device has the INMETRO seal and registration with the Brazilian Health Surveillance Agency thus ensuring compliance with national standards This device also complies with the requirements set by the European Union MDD 93 42 and can be marketed in the European market Vulcan was designed for use by dental and medical professionals The dentist or physician is respon sible for learning the techniques used in this system Improper use may result in irreversible damage The manufacturer recommends reading the entire manual before using the product DEVICE FUNCTION The device Vulcan has the function of rotating electric engines INDICATIONS Indications are many within the areas of dentistry and medicine As an example e Orthopedic Procedures e Wrist and Ankle Arthroscopy e Debridement for procedures in ENT Bone cuts e Drilling Inserts e Bone Thinning in general CLASSIFICATION Standard Policy Classification Device Class Econ and Type B Applied Part MDD 93 42 European Union 185 2001 ANVISA VULCAN Us2. B PUMP HOSE C ROLLER D SMALLER HOSE To be connected to the section 2 and the serum connector LARGER HOSE be connected to the section and the handpiece F SERUM CONNECTOR CLEANING OF MICRO ELECTRIC MOTOR MINI SHAVER CONTROL BOX AND PEDAL e The device should be unplugged before cleaning in order to prevent user exposure to electrical shock e Do not wash the control box the pedal the micro electric motor and the mini shaver it will result in loss of warranty cleaning of the same is to pass a soft cloth moistened with disinfectant solution allowing the liquid to remain on the surface in question for the time recommended by the manufacturer micro electric motor protective cover must be attached at the time of cleaning it Be sure to not drain liquid in the control box as this may damage it VULCAN User Manual SETUP Plug the power cord into the back of the device Connect the control pedal in the front of the device Connect one handpiece in the Micro Electric Motor or a blade in the Mini Shaver Insert the Electric Motor Micro or Mini Shaver connector in front of the control box e Then insert the cable A C in the power grid The potential equalizer must be connected to a potential equalization bus of the electrical installation INSPECTION BEFORE USE Check that all sections listed in SETUP are connected HOW TO USE When pressing t
3. 2006 23 24 VULCAN User Manu al Minimum recommended separation distances between portable and mobile RF communications device and Vulcan Vulcan is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The custo mer or Vulcan user can help prevent electromagnetic interference by maintaining minimum distance between portable or mobile transmitters RF communication device and Vulcan as recommended below according to maximum output power of the communications device Maximum rated output power Separation distance according to transmitter frequency m of the transmitter W 150 kHz to 80 MHz 80MHzup to 800 MHz 800 MHz up to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 12 23 10 3 7 3 7 7 4 100 12 12 23 For transmitters with a maximum ra be determined by an equation applicable to the transmitter frequency ed power output not listed above the recommended separation distance in meters m Note 1 At 80 MHz to 800 MHZ i applies to the separation higher frequency band Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflec tion from structures objects and people Table 4 Recommendations for separation distances between the device and RF emission sources based on the Table 206 60601 1 2 2006 SYMBOLS USED Potentia
4. lt Stopped gt gt Driven in Direct Mode lt lt Driven in Reverse Mode lt gt Driven in Swing Mode D Rotation Changing the rotation and flow To change the rotation and flow of the device press as the panel display Starting the Mini Shaver To start the engine use the pedal as section CONTROL PEDAL In the absence of the pedal you can trigger the Mini shaver with the keys 4 as section FRONT PANEL FUNCTIONS VULCAN User Manual MENU SETUP The device has a configuration menu for the user which is allowed to e Load preset factory programs Select the Micro Electric Motor brake e Calibrate the Micro Electric Motor Mini Shaver e Calibrate the control pedal Osc To access the settings menu press and hold the key during startup of the device Use or Cr scroll through the options and the Key SS to confirm Standard Programming Select Startup Programs then press the button Cres to confirm the restart of the preset factory programs Brake Setting Select Brake Setting then press the key to enter the function and select the desired brake for Osc Micro Electric Motor for example 10 or 100 Press after choosing to confirm the setting The higher the value selected the faster the motor will stop The brake for Mini Shaver is determined in 100 Micro Electric Motor Mini Shaver Calibration The calibration of the
5. Micro Electric Motor should be performed with the respective cover and it should be positioned on the support The calibration of the Mini Shaver should be performed without any blade is connected to the same Select Calibrate Engine following the procedures described in display Control Pedal Calibration Select Calibrate Pedal press the key to confirm Leave the central button of the pedal free and press the key for calibration of the minimum value Then fully press the center button of the pedal and the key gt for calibration of the maximum value Exit the Settings menu Select Exit and press the 22 Important Notes ZA The unit has a display with a user friendly menu Alert messages can be displayed in the same Caution Use of controls or adjustments or performance of procedures other than those speci fied herein may be harmful to the patient the operator or device POST SURGICAL PROCEDURES e Turn off the on off switch located on the rear panel e Disconnect the cable A C in the power grid e Disconnect the Micro Electric Motor Mini Shaver and the control pedal of the front of the device the connector never pull on the cable Micro Electric Motor Mini Shaver the control box and pedal should be cleaned as section MICRO ELECTRIC MOTOR MINI SHAVER CONTROL BOX AND PEDAL CLEANING PROCEDURE OF EXCHANGE AND FUSE CHECK Disconnect the cable A C from the p
6. the Field intensity established by he RF transmitter as determined by an electromagnetic inspection at the sitea is less than the compliance level in each frequencyb range nterference may occur around the device marked with the ollowing symbol Cp NOTE 1 at 80 MHz and 800 MHz it applies the higher frequency band NOTE 2 These g reflection from stru Field strengths es ctures objects and people uidelines may not apply in all situations E ectromagnetic propagation is affected by absorption and ablished by the fixed transmitters such as base radio stations telephone mobile wireless and land mobile radios amateur radio AM and FM radio broadcast and TV transmitters cannot be theoretically predicted with accuracy To assess inspection on site above Vulcan sho the electromagnetic environment due to fixed RF transmitters it is recommended an electromagnetic f the measured field intensity at the location where Vulcan is used exceeds the level of conformity used 4 be observed to see whether the operation is normal If abnormal performance is observed additional measures may be necessary such as reorientation or replacement of Vulcan Over the requency range from 150 kHz to 80 MHz the field strength should be less than 3 V m Table 3 Conformity information to electromagnetic immunity requirements for device not intended to LIFE SUPPORT based on the Table 204 60601 1 2
7. corresponding to the minimum level and FL8 to the maximum level The pump will be triggered only when the LED on the key is lit and the pedal is pressed 10 S By pressing this key the irrigation pump is turned on and the LED on the key will light up To turn it off press the key again VULCAN User Manual BACK PANEL COMPONENTS Vulcan A Micro blower Air output location It should not be obstructed B Cable A C Connector Location where the power cord should be connected to Holder Fuses Location where the fuses are inserted into the device D On Off switch It turns on and off the control box E Potential Equalizer This connector establishes a equipotential connection It is recommended that the connection to ground is made by qualified personnel F Support Serum rod socket location optional G Connecting nipple 1 Docking location of the larger hose irrigation kit optional H Connection nipple 2 Docking location of the smaller tube irrigation kit optional I Peristaltic Pump Serum irrigation system optional J Serum rod Serum support location optional gt 1 gt CONTROL PEDAL 2 9 1 REV e Micro Electric Motor Enables disables the REV function with the function enabled the engine will rotate counter clockwise This function is possible only when a drill handpiece is connected to the engine e Mini Shaver Drives the engine in reverse counterclock
8. ed above are exclusive use of Vulcan device VULCAN User Manual FRONT PANEL FUNCTIONS A Control Pedal Footswitch connection location B M1 and M2 The unit has two output connectors for connecting Electric Motor Micro or Mini Shaver 1 By pressing this button you can select the output connector to the motor 1 or 2 section The motor selection will be indicated by green LEDs or II located above this button 2 Rotation Increases or decreases the engine rotation 3 C amp S By pressing this key you can select the model of micro saw The key or changes the selection 4 amp This button allows to e Trigger the Mini Shaver in reverse mode e Browse among the options of the language and settings selection menu Choose the drill model e Choose the model of micro saw 5 994 This button allows to e Trigger the Mini Shaver in oscillating mode The speed limit for this mode is 3000 rpm e Access to the language and settings selection menu e Acts as selection button of on screen adjusted parameter 6 9 This button allows to e Trigger the Mini Shaver in direct mode Browse through the options of the language and settings selection menu e Choose the drill model e Choose the model of micro saw 7 Graver Access to Shaver mode 8 Coa Provides access to Drill mode and choosing a model 9 Flow 9 Allow adjustment of the pump irrigation level FL1
9. er Manual SPECIFICATIONS Micro Electric Motor Features Specifications Handpiece associated Parts with Power plug Speed Min 2000 rpm and Max 45000 rpm Cycle Time 1 minute on 2 minutes off Mini Shaver Features Specifications Handpiece associated Razek Mini Blades Speed Min 500 rpm and Max 10000 rpm General Features Features Specifications Power supply 90 240 V nput Power 200 VA Power Frequency 50 60 Hz Protection to water penetration cabinet and IPX3 pedal Peristaltic Pump aximum Flow 50 mL min Minimum Flow 8 mL min ominal Current 2 A Type T Fuse Voltage 250 V Break Capacity 35 A or L Size 25 W x 16 cm D x 21 5 cm Control Box Weight 2 000 kg Wired Pedal Weight 0 560 kg Micro Electric Motor Weight 0 390 kg Part of Mini Shaver 0 420 kg Current type Alternating current Manufactured and tested according to IEC 60601 1 IEC 60601 1 2 and IEC 60601 1 4 SAFETY IMPORTANT PRECAUTIONS Avoid working with the overheated engine If this occurs stop using and start using it alternately Do not use any component that has not been mentioned in this manual The use of different components could damage the device A If any component present damage it must not be used The use of any part accessory or unspecified material is the user s respon
10. f the manufac turer Handpieces should not contain oil residues at the time of fitting the micro electric motor as this will cause damage to the engine ZA Whenever the surgical procedure request a higher torque to the torque limit of the control box or selected by the user the device will beep the micro electric motor will stop its operation and a message appears on the display If necessary the user can acquire the micro electric motor separately at DMC Equipamentos MINI SHAVER A B A Lever It adjusts the suction flow between high and low To increase the level turn the lever toward the end of the engine and decrease turn the same towards the body B Connector for Suction System Location where will be inserted the suction tube Before using Razek mini blades check the cleaning and sterilization recommendations of the manu facturer They shall not contain oil residues at the time of fitting the Mini Shaver as this will cause damage to the engine ZA Whenever the surgical procedure request a higher torque to the torque limit of the control box or selected by the user the device will beep the engine will stop its operation and a message appears on the display If necessary the user can acquire a new Mini Shaver separately at DMC Equipamentos IRRIGATION PUMP The peristaltic pump is located at the rear of the device This consists of two nipples a roller and a pump hose A1 and A2 CONNECTION NIPPLES
11. he on off switch located on the rear panel screens will be presented with information such as product name version serial number and usage time Osc To select the language press in the corresponding screen and then or to cycle through the available options MICRO ELECTRIC MOTOR The operation screen for the use of Micro Electric Motor is represented below A Handpiece model selected micro saws or drills B Rotation C Pump Flow B Micro saw selection When you select the function press the buttons or to cycle through the avai lable options For each micro saw model there is a maximum limit of rotation stored in the device s memory It is important that the user properly select the model of micro saw to be used SmO Drill selection When you select the function Con press the buttons or to cycle through the available options For each drill model there is a maximum limit of rotation stored in the device s memory It is important that the user properly select the drill model to be used Changing the rotation and flow To change the rotation and flow of the device press as the panel display Starting the Micro Electric Motor To start the engine press the center button of the pedal as section CONTROL PEDAL MINI SHAVER The operation screen for using the Mini Shaver is shown below A Indication of Shaver Mode B Pump Flow C Engine status gt
12. is properly connected to the control panel Reset the device Contact the manufacturer 1 Writing error on the engine memory Check that the engine cable is properly connected to the control panel Reboot the device and repeat the engine calibration procedur Contact the manufacturer m Error12 Memory read failure Reset the device Contact the manufacturer Error13 Memory written failure Reset the device Contact the manufacturer Error14 Read error of the temperature sensor Reset the device Contact the manufacturer 19 20 VULCAN User Manual Error Code Error Type Possible Solutions Error15 Engine disconnected error Do not disconnect the engine with the same operating Connect engine again Contact the manufacturer Error 16 Operation error of the irrigation pump Check the fitting of the hose in the roller Contact the manufacturer 8 Engine release speed Reset the device Conduct engine calibration as section Calibration of the Micro Electric Motor Mini Shaver Contact the manufacturer Error19 Engine speed below the selected speed Reset the device Conduct engine calibration as section Calibration of the Micro Electric Motor Mini Shaver Contact the manufacturer ER A Device does
13. l equalization tetmindl Applied part Type B Caution Consult Accompanying Documents v gt Protected against spraying Unshielded Ey 4 7 Do not over On with electric power supply y el 2 SN without electric power supply Made by EO Pedal connection Alternating Current Serial number Temperature limits 10 C 40 C Indicates the position Fragile of transport p _ 7 t should not be exposed Protect against radiation aN to sunlight Maximum stacking Keep it dry may 25 26 VULCAN User Manual WARRANTY A The device manufactured and or marketed by DMC are warranted for 24 twenty four months from the date of purchase against defects in workmanship B The warranty covers only manufacturing defects or materials used in the manufacture of the pro ducts The warranty does NOT cover shipping expenses C The warranty is automatically canceled if occurs electrical physical abuse if the parts are changed or if there are different applications other than those for which the device was developed D In the case of device repaired outside the warranty period it will only cover the replaced compo nents E The most common causes of defects come from physical shock applied to the unit where the warranty is canceled DMC is not liable for personal injury or property damage resulting from misuse of the device i
14. mer or user should ensure that it is used in such an environment Test Test level of Level of Electromagnetic Environment y ABNT NBR IEC60601 conformity Guideline Floors should be wood concrete or cera Electrostatic discharge 6 kV by contact mic If floors are covered with synthetic ESD IEC 61000 4 2 8 kV by air material the relative humidity should be at least 30 fast electrical 2 kV on power supply lines Quality of power supply should be transient pulse train 2 Burst 1kVon the input Complies that of a typical commercial or hos IEC 610004 4 output lines pital environment Suges 24 line t0 ground compes of atypical commercial or hosp IEC 61000 4 5 1 KV line s to line P a P environment lt 5 U gt 95 voltage drop in Ut for 0 3 cycles Quality power supply should be that 4 40 U f Voltage dips short in of a typical commercial or hospital 60 voltage drop in Ut terruptions and voltage avs il environment If the Vulcan user variations on power 1255 requires continued operation during supply input lines vee Complies power interruption it is recommen i IEC 61000 4 11 Oe aropin Uy ded that Vulcan be powered from for 25 cycles lt 50 U an uninterruptible power supply or gt 95 voltage drop in Ut battery for 5 seconds Magnetic field at Magnetic fields in the frequency of apok eaten the supply sh
15. ndards and electromagnetic immunity Guideline and manufacturer s declaration Electromagnetic Emissions for all Device and System IEC 60601 1 2 2006 subcl 6 8 3 201 a 3 Vulcan is intended for use in the electromagnetic environment specified below The Vulcan user or customer should ensure that it is used in such Electromagnetic Environment Guideline Vulcan uses RF energy only for its internal functions Therefore its RF emissions are very low and not likely to cause any interference in nearby electroni device an environment Immunity Test Conformity RF emissions noe ABNT NBR IEC CISPR 11 p Meets RF emissions Class ABNT NBR CISPR 11 Harmonic emissions Class B IEC 61000 3 2 Emissions due to voltage flicker fluctuation Complies IEC 61000 3 3 Vulcan is suitab including dome e for use in all establishments stic establishments and those directly connec bution of low voltage that feeds buildings for residential use ed to public electricity distri Table 1 Conformity information to electromagnetic emissions requirements based on the Table 201 6060 1 2 2006 21 22 VULCAN User Manual Guideline and manufacturer s declaration Electromagnetic Emissions for all Vulcan IEC 60601 1 2 2006 subcl 6 8 3 201 a 6 Vulcan is intended for use in the electromagnetic environment specified below The Vulcan custo
16. not turn on ake sure the cable A C is well connected ease check with the cable A C unplugged if the fuse is blown as section PROCEDURE OF EXCHANGE AND FUSE CHECK Make sure the outlet is working properly 1 ER B The device turns on but the engine does not turn Check if the engine cable is properly connected to the control panel Check if the control pedal is properly connected Send the device for the Manufacturer s technical as sistance ER C The Peristaltic Pump is not irrigating Make sure that the hose pump is properly fitted Check if any of the hoses is broken or clogged Check that the roller pump is spinning Send the device for the Manufacturer s technical assistance The set does not perform as expected Check the wear of drills saws and blades Replace the blade Replace the micro saw Replace the drill Replace the engine Send the device for the Manufacturer s technical assistance DISPOSAL After the end of lifetime of the product and its accessories it may cause environmental contamination or may be misused To minimize these risks the customer must dispose of the device as required by local law BIOCOMPATIBILITY No part of the device touches the patient so the ISO 10993 standards do not apply DEVICE ELECTROMAGNETIC SAFETY STANDARDS Below are described tables representing the adjustment to emission sta
17. ould be at levels cha pae y 3 A m Complies racteristic of a typical location in a IEC 61000 4 8 typical commercial or hospital envi ronment NOTE Ut is the supply voltage a c before application of the test level Table 2 Conformity information to electromagnetic immunity requirements based on the Table 202 60601 1 2 2006 Guideline and manufacturer s declaration Electromagnetic Immunity device that is not LIFE SUPPORT IEC 60601 1 2 2006 subcl 6 8 Vulcan is intended for use in the electromagnetic environment specified below The Vulcan customer or user should ensure that it is used in such an environment Immunity Test Test level of ABNT NBR IEC 60601 Level of conformity Electromagnetic Environment Guideline RF Conducted IEC 61000 4 6 RF Radiated IEC 61000 4 3 3 Vrms 150 kHz up to 80 MHz 3 V m 80 MHz up to 2 5 GHz 3 V m Portable and mobile RF communication device should not be used near any part of Vulcan including cables with sepa ration distance less than the recommended calculated from he equation applicable to the frequency of the transmitter Recommended separation distance D 10 10 m D 10 10 m 80 MHz up to 800 MHz D 20 20 m 800 MHz up to 2 5 GHz Where P is the maximum output power of the transmitter in watts W according to the transmitter manufacturer and D is the recommended separation distance in meters m t is recommended that
18. ower grid and device With the aid of a small screwdriver pry both ends of the fuse holder cover see gure until you can remove it by hand Remove each fuse and check if they are burned see if the fuse is dark or with a broken filament e If necessary replace the blown fuse using the spare fuse supplied or another of qual value and characteristics see section SPECIFICATIONS e Insert the fuse holder into the receptacle until it locks e PREVENTIVE MAINTENANCE The device must be calibrated at least every two years by the manufacturer If this maintenance is not performed the manufacturer assumes no responsibility for security in the operation thereof All support services such as alterations repairs calibration etc can only be performed by the manufacturer The circuit diagrams lists of components descriptions instructions for calibration and testing are not available to persons not qualified by the manufacturer maintenance or other assistance service is carried out by non authorized personnel the manufac turer assumes no responsibility for security in the operation of the device VULCAN User Manual Never open the control box Call the technical assistance of DMC Equipamentos in case of ope rating problems CONDITIONS OF USE STORAGE AND TRANSPORT e Following are the conditions of use storage and transport of the device Protect against dust expos
19. sibility Never use worn drills or saws Never lubricate the Micro Electric Motor Mini Shaver Never connect or remove a drill or micro saw or mini blade with the Micro Electric Motor Mini Shaver connected Only trained people can operate the device Improper use may result in irreversible damage ZA Only the components covered in this manual can be used together with the device The device should not be used with cables and accessories that are not supplied by DMC which could result in emissions increase or decrease the immunity of the device The device should not be used close to or stacked with other device If necessary the device is recommended to be observed to verify normal operation in the configuration in which it will be used VULCAN User Manual COMPONENTS LIST Vulcan consists of the following parts and accessories Vulcan PARTS Control Box Cabinet Micro Electric Motor Mini Shaver Peristaltic Pump Optional Control Pedal Micro Electric Motor Support 00 Micro Electric Motor Cover Serum Rod Optional gt Cab e AIC Larger Hose Optional 02 Fuses ACCESSORIES USER MANUAL User Manua WARRANTY TERM Warranty Term 2 Serum Connector Optional Ss Smaller Hose Optional Case for Transport All accessories and parts describ
20. t produced and or marketed getting to the user to provide security measures in order to prevent such occurrences G Responsibility for the DMC regarding the use of the device and its consequences limited to the replacement value of the same The device will only be warranted by the manufacturer if Assembly extensions adjustments modifications or repairs operations are carried out by persons authorized by it e The electrical installation of the environment in question is in accordance with the appropriate requirements device is used according to instructions LIIITE TTE ALITTLE TTI ALIETTE TET ALITTLE TLE TTI PMC IMPORTAGAO EXPORTAGAO DE EQUIPAMENTOS LTDA Rua Sebasti o de Moraes 831 Jardim Alvorada S o Carlos SP CEP 13562 030 CNPJ 02 827 605 0001 86 Tech Manager Renaldo Massini Jr CREA 0601706815 ANVISA Registration 80030810125 Technical Name Electric Engine Technical Assistance DMC EQUIPAMENTOS LTDA Tel 55 16 2107 2323 Fax 2107 2320 21 MAN 89 2 Rev 01 Data de Revis o 20 03 2012
21. ure to direct sunlight away from chemicals and cleaning agents Temperature 10 C 40 Humidity 30 to 75 Atmospheric pressure 700 hPa to 1060 hPa Avoid dropping the device Keep the device a safe place preventing submit it to blows and vibrations MAIN PROBLEMS AND POSSIBLE SOLUTIONS Error Code Error Type Possible Solutions Error01 Micro blower blocked Check obstruction in micro blower Reset the device Contact the manufacturer Error02 High internal temperature error in the control box Clearing the air outlet Check the operation of the micro blower Contact the manufacturer Error04 Exceeded torque limit Do not block the engine Contact the manufacturer Error06 Error during engine calibration Check that the motor cable is properly connected to the control panel Conduct engine calibration as section Calibration of the Micro Electric Motor Mini Shaver Contact the manufacturer Error08 Read error of Pump calibration Reset the device Contact the manufacturer Error09 Non calibrated engine Check that the engine cable is properly connected to the control panel Conduct engine calibration as section Calibration of the Micro Electric Motor Mini Shaver Contact the manufacturer Error10 Engine calibration reading error Check that the engine cable
22. wise 2 CENTRAL BUTTON e Micro Electric Motor Drives the engine the maximum speed is selected on the control panel and the same varies with the pressure held on the pedal e Mini Shaver Drives the engine in oscillating mode The speed limit for this mode is 3000 rpm 3 DIR PUMP e Micro Electric Motor It allows you to enable disable the pump irrigation function By pressing the button the LED on the key light up in the Command Mini Shaver Drives the engine in direct mode clockwise MICRO ELECTRIC MOTOR The Micro Electric Motor has a Power plug The handpiece should perfectly fit into Micro Electric Motor thus preventing shaft wear Speed limits depend on the attached handpiece micro saws or drills The user must correctly select the handpiece attached to the Micro Electric Motor If the user selects a handpiece on the control panel and fits a different model to the one selected the device will not present the expected results and may be damaged 12 VULCAN User Manual Micro Electric Motor Support This support serves as the Micro Electric Motor rest support Micro Electric Motor Cover This cover should be used during calibration and cleaning of the micro electric motor Handpieces Micro saws and drills are to be used in conjunction with Vulcan These should have Power plug Before using the micro saw or drill check the cleaning and sterilization recommendations o
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