User Manual
Contents
1. Dear customer Thank you for choosing VDW CONNECT Drive By opting for VDW CONNECT Drive you have acquired a product that was developed and tested with maxi mum care to meet the highest standards in terms of performance and handling Instructions for Use are always kept up to date by VDW to bring them in line with the latest developments You will find the current version on www vdw dental com manuals and in your VDW CONNECT app In countries where the legal situation enables us to do so we have decided not to produce a printed version of these instructions for use for environmental reasons Printed English instructions for use are always enclosed with your product If no printed version in your national language is enclosed and you wish to have a printed version of your in structions for use we will be happy to send you a copy free of charge within 7 calendar days to any address in the EU Simply order your free copy at www vdw dental com manuals These instructions for use are available in other languages upon request The pictures in this user manual in chapter 10 Operation with VDW CONNECT and iPad may vary slightly from the current VDW CONNECT app This manual has been created with the greatest care but even with all our efforts errors can never be entirely excluded Suggestions for improvements are welcome anytime Please contact VDW GmbH directly with any related comments or suggestions VDW GmbH re2. Noe Protibe 19 10 1 4 Control Panel Shortcuts and Favourites Shortcuts and Favourites provide you with fast access to all available instrument systems sequences and instruments r LI Gets a re FO CONNECT Preset Shortcuts blue The following preset shortcuts blue tiles can be found on the control panel Blue Blue Shortcuts Description Suerte Description Access to the RECIPROC system Create My Sequence My Instrument Create new instrument with respective torque and speed values Access to the Mtwo system Access to all the available instrument systems My Favourites white You have the option of creating your own favourites for instrument systems sequences and individual instru ments They are shown as white tiles on the control panel Favourites Favourites example example Description Description Example Example IT Shortcut to Mtwo sequence IT Shortcut to Mtwo instrument 10 04 60 04 10 04 20 10 1 5 Status Bar Bluetooth connection Connected handpiece Handpiece battery charge Connection status Current instrument setting e Scanning e Not Connected e 3 Connecting e Serial number here H1 3 Re connecting e Demo Mode displayed in demo mode only 21 10 2 Connect Disconnect and Customise Handpiece 10 2 1 Connect Handpiece You will find details on app installation and connecting of the han
3. b 2 5 m H f DEBET i 183m l ai Ee 7 N N I 1 83m 4 SSS SS ee Figure 1 Minimum distance between iPad charger iPad with plugged in charger and patient N 4 8 Accessories e Only use original VDW components accessories and spare parts Original VDW accessories VDW REF Handpiece VDW 6 1 contra angle Charger with national adapters Handpiece holder stainless steel Plastic cradle handpiece holder Spray adapter for manual lubrication contra angle Stand for iPad mini Case for iPad mini Sleeve for iPad mini Handpiece sleeve V041185000502 V041185000504 V041185000501 V041185000508 V041185000509 V041185000506 V041185000500 V041185000510 V041185000507 V041185000503 e Using other makes of accessories spare parts can lead to increased emission of electromagnetic interference or to reduced electromagnetic interference immunity 10 4 9 Apex Locator e Only use apex locators approved by VDW 4 10 Repairs and Defects e Do not use the device if you suspect damage or defect e Repairs alterations and modifications to the device are not permitted without the manufacturer s prior consent VDW GmbH declines all responsibility if the device has been altered or modified If a defect should occur contact VDW or your VDW authorised service partner e Before opening the housing the device must be disconnected from the power supply by un plugging the charger from the mains 4 11
4. Do not install an iOS update before VDW has approved it Check the compatibility of an iOS update on the info page of the VDW CONNECT app see Section 10 8 Update of the User Manual VDW reserves the right to change the user manual In that case an update for your user manual will be available The prerequisite for updating is an internet connection You will be informed whenever an update is necessary In addition you can always check under Info whether your user manual is the most current one In case there is a new version available the version number appears in blue Tap the blue version number for updating your user manual 10 9 2 Handpiece The handpiece firmware is updated via the app An update can take a few minutes Before updating make sure the battery in your handpiece is at least 80 charged or connect the handpiece with the charging cable Before updating make sure the battery of your iPad is at least 60 charged or connect the iPad with the charging cable Place the handpiece 1 m from your iPad and only remove it when the update has been completed VDW will inform you of upcoming firmware updates In addition you can check the info screen whether your version of the handpiece firmware is still current If a newer version is available the version number on the info screen appears in blue By tapping the blue version number you can start the update 10 10 Demo Mode In Demo Mode you can test the VDW CONNECT
5. Transport e ntact devices can be transported by land freight or air freight in the original packaging The applicable requirements must be met Table 1 e Defective devices can also be transported by air freight or land freight in the original packaging If the battery is defective the device must not be transported by air freight under any circumstances Leaking liquid can be an indicator of a defective battery Table 1 Standards and regulations that apply to the transport of VDW CONNECT Drive Air freight Land freight Intact device or e UN 3481 Lithium batteries in e UN 3481 Lithium batteries in defective device with equipment equipment intact battery e IATA Packing instruction 967 e ADR Special provisions 188 f Part Il and g e Special regulations issued by airlines and national regulations must be complied with Device with defective e Not possible International multilateral agree battery ments M 228 and M 259 e ADR SV 661 international road e Regulations issued by GRS German Joint Battery Take back System Foundation for the transport of waste lithium batteries FRG road 11 5 Precautions 5 1 VDW CONNECT App BGB X Use of the VDW CONNECT app is optional e VDW CONNECT app updates are binding and serve to enable safe preparation Install them as soon as possible see Section 10 9 e Messages from other apps must be disabled VDW recommends closing all other apps 6 Adverse Reactions None kno
6. 47 47 1 Symbols Used 1 1 In These Instructions for Use A WARNING Ess NOTE D gt CROSS REFERENCE 1 2 On the Product Packaging QD Z ire Ok MENG Z c Ee If the instructions are not followed properly operation may lead to hazards for the product or the user patient Additional information explanation of operation and performance Points out where additional information on a certain topic can be found Serial number Catalogue number Manufacturer Date of manufacture Safety class II device Type BF applied part CE marking DC current Bluetooth Not for reuse Washer disinfector Tap here when using the VDW CONNECT app ACPEIP China RoHS pO I N ce o CH c ce o CH co e E A a a ea a a ry Cu c sp cs gt E 106 kPa 50 kPa IMPORTANT Refer to Instructions for Use Do not dispose of with normal household waste PC Ghost Symbol Russia Temperature limits Storage humidity range Store in a dry place CAUTION Fragile AC current In EU countries the Instructions for Use are available in electronic form Please consult the Getting Started brochure for more information Can be autoclaved up to a maximum temperature of 135 Celsius Non sterile Swipe here when using the VDW CONNECT app Atmospheric pressure limitation 2 Intended Use A cordless motor for dental root canal tr
7. a spray never spray directly onto the handpiece pes 41 e Wear protective clothing e Only use surface disinfectants that are certified by officially recognised institutes do not contain chlorine and have been declared aldehyde free e Please refer to the manufacturer s information on use of the disinfectant e When subjecting the handpiece to disinfection ensure that the charging cable is not connected and that the charging socket is closed ole D Figure 4 Closed charging socket for handpiece disinfection e Never place the components in a washer disinfector autoclave or ultrasonic bath 12 3 Cleaning Disinfection and Sterilisation The contra angle must be cleaned disinfected and sterilised before the first treatment and after every subsequent treatment Clean and disinfect the contra angle immediately after every treat ment in order to prevent debris from clinging According to a recommendation by the Robert Koch Institute a distinction must be made between device based and manual reprocessing whereby device based reprocessing is always preferable In the following you will find instructions concerning device based and manual reprocessing lubrication and sterilisation a Figure 5 Contra angle Comply with the following instructions before you commence cleaning disinfection and sterilisation e VDW recommends device based cleaning in a washer disinfector Please refer to the manufacturer s information co
8. gt Charge battery Preparation in reciprocating mode RECIPROC REVERSE function 2 step warning signal for details see Section 8 5 in case the instrument is subjected to increased friction Preparation in rotary mode ASR Auto Stop Reverse comfort function Acoustic warning signal e beep if torque exceeds about 75 of the preset value e ntermittent beep in the event of counter clockwise rotation Recommendation Clean the instrument briefly adopt a brushing motion to create more space in the root canal reduce pressure on the instrument possibly recapitulate with a C PILOT FILE ISO size 10 14 8 5 RECIPROC REVERSE Comfort Function The RECIPROC REVERSE comfort function is a 2 step warning signal in reciprocating mode that draws attention to increased friction over the entire length of the instrument This function is enabled by default RECIPROC REVERSE tones Recommendation First signal Deep e Draws attention to increased friction over the entire length of the instrument The tone continues as long as the increased friction continues Therefore it is necessary to perform a lateral brushing motion to enlarge the canal That relieves the inst rument and preparation can continue with the usual motion This indicates that the instrument is being subjected to even higher friction The micromotor switches to clockwise rotation to relieve the instrument That withdraws the instrument from the root canal If the instrumen
9. of the screen Q Tap REV to enable reverse rotation O Tap REV again to disable the function button appears grey button appears white 10 5 3 Difficult Canal When you have selected a rotary instrument in the VDW CONNECT app the Difficult root canal button Ncm appears in the lower third of the screen Tap Ncm to enable the function O Tap Ncm again to disable the function button appears grey button appears white 30 10 5 4 Calibration W Do not insert an instrument for calibration purposes 1 Attach the contra angle 2 Select any rotary instrument 3 Tap CAL to the handpiece via the VDW CONNECT app A X 4 The ON OFF button on the 5 Now press the ON OFF 6 You see a progress bar that handpiece flashes green button note after 30 s the disappears as soon as cali The handpiece is ready for handpiece is no longer ready bration has been completed calibration for calibration successfully P 31 10 6 User Profiles The following settings are assigned to your user profile e Favourites e My Sequences e My Instruments e Customised torque and speed settings for individual instruments In addition the following settings that you make using Settings are also assigned to your profile e Language selection e Indication of units torque and speed e Option Multifunction Button see chapter 10 7 3 10 6 1 Create User Profile 1 Tap the profile symbol on the navigation bar 2 Ta
10. Change the contra angle 2 Start the calibration procedure again The battery is not 10 1 Charge the battery until the battery sufficiently charged to LED is continuously lit green 1 perform an update of the 2 Perform the software update again handpiece firmware General error in the 11 Perform a reset See Section 11 oO handpiece firmware 12 Cleaning Disinfection and Sterilisation Regular maintenance of VDW CONNECT Drive is essential to ensure that work performed is comple tely hygienic and that the device will have a long service life The components of VDW CONNECT Drive have not been disinfected or sterilised upon delivery Please perform the necessary steps before the first treatment In your responsibility for the sterility of the accessories always make sure that only validated me thods of cleaning disinfection and sterilisation are used that the equipment disinfector steriliser is subjected to regular maintenance and inspections and that the validated parameters are maintained in every cycle Comply with your national guidelines standards and requirements for cleaning disinfection and sterilisation 12 1 Single Use The following infection control measures are obligatory when working with VDW CONNECT Drive e the cover for iPad mini and e the handpiece sleeve Both products are designed for single use and have to be disposed of and changed after every treat ment In the event of non compliance the c
11. O ban o idi OH es Delete favourites Remain on the white tile until the Delete cross appears Tap the Delete cross to delete 27 10 4 Working with Reciprocating Instruments Taking RECIPROC as an Example 10 4 1 Select RECIPROC Instrument Tap the blue shortcut RECIPROC on the control panel of your home screen No further settings are required You can start with RECIPROC preparation immediately Please follow the RECIPROC Instructions for Use which can be found at www reciproc com 10 4 2 Enable Disable RECIPROC REVERSE Comfort Function The RECIPROC REVERSE comfort function is a 2 step warning signal in reciprocating mode that draws attention to increased friction over the entire length of the instrument e The RECIPROC REVERSE comfort function is enabled by default For this purpose refer to Section 8 5 e For optimal work with RECIPROC VDW recommends having the RECIPROC REVERSE comfort function enabled at all times If you nevertheless wish to disable the function proceed as de scribed below When you have selected a reciprocating instrument in the VDW CONNECT app the RECIPROC REVERSE button appears in the lower third of the screen Tap the RECIPROC REVERSE button to O Tap the RECIPROC REVERSE button again disable the RECIPROC REVERSE function to enable the RECIPROC REVERSE function button appears white again button appears grey VOW CONNECT 28 10 5 Working wit
12. achment of the instrument or cause the pushbutton to overheat e Never remove the contra angle from the handpiece during operation e Only use undamaged root canal instruments Please refer to the information provided by the ma nufacturer e Only insert the instrument when the contra angle is stationary e Never place your fingers on the moving parts of the instrument while it is running or coming to a Stop e Before treatment check the contra angle for any damage or loose parts e Only use the original VDW contra angle 4 6 Root Canal Instruments e Before use make sure the instrument is securely locked in place e Never use continuous rotary instruments in reciprocating mode e Never use reciprocating instruments in rotary mode e Use the torque and speed settings recommended by the instrument manufacturer 4 7 iPad e Use of the iPad is optional e Apple the Apple logo and iPad are trademarks of Apple Inc registered in the U S and other countries App Store is a service mark of Apple Inc A H e Hygiene measures to prevent cross contamination are absolutely essential Use of the Sleeve for iPad mini is therefore compulsory see Section 12 1 e The operating conditions and limitations specified by Apple must be complied with e When charging the iPad maintain the minimum distances from the patient defined in Figure 1 as the iPad does not have a medical charger EDITORS IN d A 7 N l x 7 N a
13. an ultrasonic bath 12 3 2 Manual Reprocessing If you clean and disinfect the contra angle manually heed the instructions below and proceed as follows Manual cleaning e Equipment Cleaning tool brush e For 5 minutes rinse and brush under running deionised water DI water or water that has this degree of purity 38 C e Remove any liquid residues ultra absorbent cloth particle free compressed air Manual disinfection e For disinfection purposes VDW recommends the use of mikrozid AF wipes manufactured by Sch lke e Thoroughly disinfect surfaces with a soaked wipe min 30 seconds making sure the entire sur face is wetted and allow to act exposure time gt 30 minutes If large surfaces have to be treated use more than one wipe where necessary e Make sure the surface is completely dry after disinfection e Only use surface disinfectants that are certified by officially recognised institutes do not contain chlorine and have been declared aldehyde free Please refer to the manufacturer s information on use of the disinfectant Ux 43 12 3 3 Device based Reprocessing If you clean and disinfect the contra angle in a reprocessing device heed the instructions below and proceed as follows Automatic cleaning disinfection e Equipment Washer disinfector conforming to ISO 15883 e g Belimed WD programme neutral e Cleaning solution e g 0 596 v v deconex 24 LIQ Borer Chemie e Neutralising soluti
14. app and view all the setting options in the app To do so load the VDW CONNECT app onto your iPad from the Apple App Store start the app and tap Demo Mode Press multi function button on VDW CONNECT Drive or continue in demo mode 36 NI C Settings with the VDW CONNECT app can only be made when you connect the app to a handpiece e Demo Mode is indicated on the status bar e When you connect a handpiece the app automatically quits demo mode 11 Troubleshooting If the device is not operating properly read the following checklist If you are unable to solve the problem by referring to the checklist contact VDW GmbH or a VDW authorised service partner Beg 10 remedy certain problems it is necessary to perform a reset reboot or a factory reset to restore factory settings on the handpiece In such cases proceed as described below Reset reboot 1 Hold the multifunction button for approx 10 seconds While holding it down all LEDs on the hand piece will extinguish first and then flash white briefly 2 Let go of the multifunction button Factory reset restore factory settings 1 Hold the multifunction button for approx 20 seconds While holding it down all LEDs on the handpiece will extinguish first and then flash white briefly After another 10 seconds all LEDs will briefly light up blue 2 Let go of the multifunction button 11 1 Checklist Problem Possible error Remedy Running motor cannot be sto
15. bar of your home profile and then enable disable the Screen option Next File 34 10 8 Info VDW CONNECT App and Handpiece 1 Tap Info on the navigation bar 2 You are given the following information aver Tete ind pos maa whee coi See vedere commence D i eee Ke VU WO COHH LT Leg T 010580908 No Information Manufacturer 2 Email Tap the email address to contact us directly via email Homenpaae Tap the web address to find out more about VDW CONNECT Drive and pag our products 3 Versions VDW CONNECT App Version of the VDW CONNECT app File library Version of pre set values under All Systems Instructions for Use Version of the Instructions for Use Instrument statistics can be sent to VDW This is voluntary and statistics statistics will never be sent out without your permission Devices that can be operated with the app as well as compatible iPads E Fills and iOS versions 5 Connected ts On the list tap the appropriate device and you will be given more information 6 Handpiece firmware Version of the handpiece firmware 35 10 9 Updates To ensure safe use of VDW CONNECT Drive make sure you are always working with the latest ver sion of the app and the latest handpiece firmware 10 9 1 App iPad Operating System When installing the VDW CONNECT app the version of your iOS operating system should not be lower than 8 0 VDW checks the compatibility of new iOS versions with the VDW CONNECT app
16. d sterilisation e Steam sterilisation with fractionated pre vacuum method B in accordance with EN 13060 or EN 285 e Sterilisation holding time at least 4 minutes at 132 C or at least 30 minutes at 121 C e The fast sterilisation procedure and the sterilisation procedure with non packaged accessories are not permissible In addition do not use hot air sterilisation radiation sterilisation or sterilisa tion with formaldehyde ethylene oxide or plasma Storage Store sterile items in a dry dust free place at room temperature Additional information e Before resuming operation wait until the contra angle attachment has cooled down and is com pletely dry e Contra angles must be checked for damage before they are reused Damaged products must be replaced 45 13 Disposal Comply with your national regulations guidelines and requirements for the disposal of end of life electrical equipment and batteries Specialised dental dealers will be pleased to provide you with country specific infor mation concerning disposal Make sure the product or battery is not mixed with other types of waste when it is being disposed of Prior to disassembly and disposal your device must not be contaminated and must have been completely reprocessed Cleaning Disinfection Sterilisation 14 Warranty VDW GmbH certifies that the device has been properly designed that top quality materials have been used that all the necessary test
17. dpiece to the iPad in the Getting Started brochure e Make sure Bluetooth is enabled on your handpiece multifunction button The pairing LED starts flashing When the handpiece and the iPad are connected the pairing LED is continuously lit in the selected colour e Make sure Bluetooth is enabled on your iPad e Once you have connected to your handpiece that handpiece will be automatically connected next time you start the app 10 2 2 Disconnect Handpiece from the iPad With the VDW CONNECT app you can disconnect a connected handpiece from the iPad That is useful if you e only want to work with RECIPROC e want to connect a new handpiece 1 Tap Drive on the status bar 2 Tap the menu item 3 The handpiece is Disconnect from iPad disconnected from the iPad the pairing LED is off Disconnedsfrom iPad Ign Change Colour 22 10 2 3 Ignore Handpiece With the VDW CONNECT app you can have a connected handpiece ignored by the iPad That is useful if you do not want a certain handpiece to be automatically connected to the iPad If you want to reconnect the ignored handpiece perform the connection steps pairing again as described in the Getting Started brochure 1 Tap Drive on the status bar 2 Tap the menu item Ignore Disconnect from iPad 10 2 4 Change the Colour of the Pairing LED You have the option of changing the colour of the Pairing LED on your handpiece This can help you if multiple ha
18. eatment using endodontic instruments in torque controlled continuous rotation and in reciprocating movement FOR DENTAL USE ONLY 3 Contraindications None known Safety and effectiveness have not been established in pregnant women and children 4 Warnings Read the following warnings before use N 4 1 User The handpiece is intended for endodontic treatment and may only be used by trained and qualified professionals such as dentists A 4 2 Ambient Conditions e The device must not be placed in humid surroundings or anywhere where it can come into contact with any type of liquids Do not expose the device to direct or indirect heat sources The device must be operated and stored in a safe environment The device may be operated up to a maximum temperature of 35 C and up to an altitude of 2 000 m above sea level Do not use the device in the presence of free oxygen anaesthetics or flammable substances The device must be operated and stored in a safe environment The device can cause radio interference or interfere with the operation of equipment in the vicinity If this happens the interfering influence should be reduced by reorienting or repositioning the device or by screening off the immediate environment The electromagnetic radiation emitted by this device is below the recommended limits specified by the applicable relevant provisions EN 60601 1 2 2007 amp EN 60601 1 2006 The device requires special precaution
19. ece connected to iPad If you have selected a different colour scheme using the VDW CONNECT app the pairing LED is continuously lit in the colour selected a LED reciprocating mode Reciprocating mode activated Rotary mode activated LED rotary mode Fully charged or still sufficiently charged to be A amp A LED battery status able to perform treatment Connect with charging cable for simultaneous acoustic signals see Section 8 4 DO a a a 13 gt LED flashes red charge critically low charge immediately N 7 LED flashes green handpiece is charging 8 3 Standby Mode To save energy the handpiece switches to standby mode after a brief period There are two different steps that can be indicated by the various colour statuses of the handpiece Status of LED button Action to wake up Standby mode 1 i i HEEN Pick up handpiece or press multifunction button after 5 min of non use 38 1 Press multifunction button if battery charge is Standby mode 2 low connect with charging cable as required after 30 min of non use 2 Press multifunction button again to reactivate Bluetooth 8 4 Acoustic Signals Situation Signal Multifunction button has been Short confirmation tone beep pressed Battery status One time warning signal beep if battery status is weak motor running gt Charge battery Dominant alarm signal beep lasting 3 s as soon as battery charge is critical motor running
20. en caused by negligence on the part of the user with regard to normal maintenance as indicated in the Instructions for Use especially when subjecting the battery to charging discharging and maintenance in accordance with the Instructions for Use and with regard to careful and regular maintenance of the contra angle The warranty explicitly excludes defects that have been caused by damage in transit to VDW GmbH to a service partner authorised by VDW for the purpose of repair have been caused by atmospheric events such as lightning strike fire and moisture This warranty is automatically rendered void if the product has been improperly repaired modified or otherwise tampered with by the user or unauthorised third parties The warranty is only valid if the device sent in for repair is accompanied by the invoice confirming the date of delivery of the product Legal claims resulting from product liability law for example and claims filed with the person from whom the customer purchased the product especially ones filed with the dental dealer shall remain unaffected 46 15 Exclusion of Liability In the following cases the manufacturer declines all responsibility 1 Use of VDW CONNECT Drive for purposes and applications that differ from the specific requirements made in these Instructions for Use 2 Cleaning disinfection and sterilisation methods contrary to the directions in these Instructions for Use 3 Contra angle mai
21. ence a name 7 Your sequence is shown on and tap Save the home screen as a white tile Change and Delete My Sequence Remain on the white tile until the Edit pen and the Delete cross appear To edit tap the Edit pen and proceed as described above To delete tap the Delete cross 25 10 3 3 Create My Instrument You have the option of creating a new instrument that is not stored under All Systems Comply with the instrument manufacturer s recommendations concerning torque and speed 1 Tap the blue shortcut My 2 Enter the manufacturer 3 Your instrument is shown Instrument on the control system and instrument as a white tile on the control panel on the home screen Select torque and speed panel settings and then tap Save Please note that not every combination of torque and speed setting is possible 26 10 3 4 Save and Delete Favourites You have the option of saving an instrument system instrument sequence or instrument as a favourite white tile Save favourites 1 Select the desired instrument 2 Example Selecting a 3 The instrument is now sequence an instrument favourite instrument shown as a white tile on system or instrument using Tap the empty star opposite the control panel All Systems as described in the desired instrument The the previous sections star now appears filled in colour The instrument has been saved as a favourite gt en A we O ma Q o 6 nm Oo Fue o
22. gle trial run after lubrication 1 Attach the contra angle to the handpiece 2 Hold the handpiece upside down 3 Run the handpiece for 30 seconds to remove any excess oil 4 If dirt emerges repeat the entire hygiene and lubrication process 5 Wipe the contra angle with a paper tissue or a soft cloth Calibration of the contra angle e Always calibrate when the contra angle has been subjected to lubrication or has been exchanged after sterilisation For this purpose use the calibration function in the VDW CONNECT app Section 10 5 e Calibrate without any instrument attached If you only use the handpiece in reciprocating mode without the app no calibration is required 12 3 5 Sterilisation Packaging Shrink wrap the contra angle in sterile barrier packages conforming to EN 868 5 Sterilisation e Please refer to the information provided by the device manufacturer e Clean and disinfect before sterilisation The contra angle should also be lubricated before steri lisation e Make sure you only remove dry sterile items e Maximum sterilisation temperature 135 C 275 F e The sterilisation validation procedure must be performed in compliance with ISO 17665 valid Installation Qualification and Operational Qualification IQ and OQ and product specific Perfor mance Qualification PQ Approved Sterilisation Procedure e Comply with your national guidelines standards and requirements for cleaning disinfection an
23. h Rotary Instruments e Please refer to the instrument manufacturer s Instructions for Use e VDW CONNECT Drive has an Auto Stop Reverse function ASR If 75 of the preset torque threshold is reached a warning signal bleep sounds If the preset torque is reached the ASR function prevents the instrument from being overloaded beyond the preset torque value e The ASR function cannot be disabled 10 5 1 Change Instrument Settings You have the option of customising the default instrument settings in rotary mode e For safe use VDW recommends not changing the default torque and speed values set by the instrument manufacturer Those values are marked with a symbol e f you nevertheless wish to change the instrument settings proceed as described below 1 Select the desired rotary 2 Tap the settings wheel icon 3 Select the desired torque and instrument speed Bear in mind that not all combi nations are possible At any time you can access the Restore default settings field to restore the settings recommen ded by the instrument manufac turer 4 Tap Save to save the entry 5 Your customised settings are displayed under the instrument name The handpiece is adjusted to your settings once a appears opposite the instrument name on the status bar 29 10 5 2 Reverse Rotation When you have selected a rotary instrument in the VDW CONNECT app the REV Reverse Rotation button appears in the lower third
24. in rotary mode Class Il BF contra angle Not suitable for use in the presence of flammable anaesthetic gas mixtures or oxygen Rotary and reciprocating Use in enclosed spaces Ambient temperature 15 C 35 C Relative humidity 8096 non condensing at 0 Operating altitude 2000 m above sea level Maximum housing temperature according to IEC 60601 1 2005 Class lla MDD 93 42 ANNEX IX Rule 9 e Ambient temperature 20 C 50 C e Relative humidity 20 8096 non condensing at gt 40 C e Atmospheric pressure 50 kPa 106 kPa Bluetooth 4 0 low energy Device contains transmitter with FCC ID RFRMSR IC ID 4957A MSR See http www vdw dental com emc C C asal Manufacturer VDW GmbH Bayerwaldstr 15 81737 Munich Germany 0123 Phone 49 89 62734 0 Fax 49 89 62734 304 service vdw dental com www vdw dental com Rev 2 02 06 15
25. ncerning equipment cleaning agents and rinsing agents e Sterilise the contra angle after you have performed manual or device based cleaning and disinfection as well as lubricate e Always start with the following steps see Section 12 3 1 preparation at the point of use and manual pre cleaning e Always wear protective clothing Reprocessing limitation e Frequent reprocessing has only minimal effects on the service life of contra angles The end of the product service life is normally dependent on wear and damage caused by use 42 12 3 1 Pre Treatment Pre treatment at the place of use e Remove the root canal instrument and separate the contra angle from the handpiece e Transport No special transport container is required for the contra angle Transport is not subject to any special requirements e Wear protective gloves when processing and transporting the contra angle Manual pre cleaning e Manual pre cleaning is required for an efficient cleaning procedure Machine based reprocessing of medical devices also begins with manual cleaning e n the event of heavy soiling pre clean with disinfection wipes immediately after use Only use cleaning agents that do not have a protein binding effect Rinse the products under running water if necessary in order to remove any coarse soiling e t is not necessary to dismantle the contra angle for this purpose e Do not place the contra angle in a disinfectant solution or in
26. ndpiece from the iPad Ignore Handpiece Change the Colour of the Pairing LED Working with Instruments All Systems Create and Control My Sequence Create My Instrument Create and Delete Favourites 11 12 13 13 14 15 15 10 4 10 4 1 10 4 2 10 5 10 5 1 10 5 2 10 5 3 Working with Reciprocating Instruments Taking RECIPROC as an Example Select RECIPROC Instrument Enable Disable RECIPROC REVERSE Comfort Function Working with Rotary Instruments Change Instrument Settings Reverse Rotation Difficult Canal 10 5 4 Calibration 10 6 10 6 1 10 6 2 10 7 10 7 1 10 7 2 10 7 3 10 8 10 9 10 9 1 10 9 2 10 10 11 11 1 11 2 User Profiles Create User Profile Delete User Profile and Change Profile Name Settings Language Units Option Multifunction Button Info VDW CONNECT App and Handpiece Updates App Handpiece Demo Mode Troubleshooting Checklist Error Messages 32 32 32 33 33 35 35 35 35 36 36 38 12 12 1 12 2 12 3 12 9 1 12 3 2 ESCH 12 3 4 12 9 0 13 14 15 16 17 Cleaning Disinfection and Sterilisation Single Use Disinfection Cleaning Disinfection and Sterilisation Pre Treatment Manual Reprocessing Device based Reprocessing Lubrication Sterilisation Disposal Warranty Exclusion of Liability Technical Data EMC Tables 39 39 40 42 42 43 43 44 45 45 46
27. ndpieces are being used in your practice and you would like to visually distinguish them from one another handpiece must be charged and connected to the iPad 1 Tap Drive on the status bar 2 Tap the menu item Change Colour Ignore Change Colour 3 Select the desired colour and 4 The Pairing LED of the handpiece and the tap Save icon on the status bar of the VDW CONNECT app are now lit in the selected colour Drive B 23 10 3 Working with Instruments 10 3 1 All Systems With All Systems you can select all instrument systems sequences and individual instruments Example selection of Mtwo instrument 15 05 W VDW reserves the right to update the instruments under All Systems Therefore keep the VDW CONNECT app up to date for the latest amendments 24 10 3 2 Create and Control My Sequence With My Sequence you have the option of compiling your custom instrument sequence Your custom ised sequence will then be shown as a favourite white tile on the control panel Create My Sequence 1 Tap the blue shortcut My 2 First select the instrument 3 You can alter the order of Sequence on the control system Then select the instruments by moving the panel on the home screen instrument that you wish to file entries Drag amp Drop add to your sequence The 4 You can delete instruments selected instruments appear py clicking the Delete on the bottom bar symbol 5 Tap Save 6 Give your sequ
28. ntenance contrary to the directions in these Instructions for Use 4 Work or repairs performed by unauthorised persons 5 VDW accepts no liability for damage caused to or by the iPad 6 Rights under the warranty or statutory guarantee are rendered void if the device is opened without permission T Electrical installations in the room must meet the provisions of IEC 60364 7 710 Installation of electrical equipment in rooms used for medical purposes and the regulations applicable in your country 8 If you have any questions contact your dealer or VDW GmbH 16 Technical Data Manufacturer Model Dimensions Material Weight Contra angle Power supply Charger power supply Frequency Charger nominal power input Torque range Speed range of the micromotor shaft Electrical safety class Applied part Safety level in the presence of flammable anaesthetic gas mixtures or oxygen Operating mode Ambient conditions Medical device classification Transport and storage conditions Bluetooth 17 EMC Tables 47 VDW GmbH Bayerwaldstr 15 81737 Munich Germany VDW CONNECT Drive 206 mm x 24 6 mm x 24 8 mm PBT PET Stainless steel 316L Silicone 180 g Contra angle compatible with rotary and reciprocating instruments equipped with a 2 35 mm shaft conforming to ISO 1797 1 2011 Type 1 Lithium ion battery 3 6 V 2000 mAh 100 240 V 50 60 Hz 5 5 VA 5 mNm 50 mNm 0 5 Ncm 5 Ncm 1200 5100 rpm
29. on e g 0 25 v v deconex 26 plus Borer Chemie e Cleaning at 65 C holding time 5 minutes e Disinfection at 90 C holding time 5 minutes e The water quality to be recommended for cleaning is deionised DI water or water that has this degree of purity e Drying is performed automatically during the drying cycle in the washer disinfector Make sure the contra angle attachment is completely dry after thermal disinfection Remove any liquid residues with particle free compressed air 12 3 4 Lubrication It is essential to subject the contra angle to lubrication after every internal cleaning procedure be fore every sterilisation or after 30 minutes of use but at least once a day Lubrication Lubricate the contra angle immediately after thermal disinfection e When performing contra angle lubrication ensure that no oil penetrates the handpiece Contamina tion of the handpiece with oil can damage it and have a negative impact on safety when it is being operated e Use the spray adapter included for manual lubrication e VDW recommends the use of a fully automatic reprocessing device for the contra angle e g the Assistina from W amp H Please perform the following steps for manual lubrication Remove spray adapter cap O Attach spray adapter to oil can e g W amp H Service Oil MD 400 Perform contra angle lubrication according to the information in the Instructions for Use of the oil spray can 44 Contra an
30. ontamination risk increases 40 12 2 Disinfection In addition to using the handpiece sleeve clean and disinfect the handpiece regularly The handpiece is NOT approved for device based cleaning washer disinfector and sterilisation a e D Handpiece The following components must be cleaned and subjected to disinfection before the first treat ment and immediately after every subsequent treatment They are not approved for device based cleaning washer disinfector and sterilisation J A Charging cable a CRAP RD Stand for iPad mini Handpiece holder c Case for iPad mini accessory accessory Spray adapter for manual lubrication aintenance Figure 3 Overview disinfection Disinfection 1 Separate the plastic cradle from the stainless steel base of the handpiece holder and take the case off the iPad mini 2 In the event of heavy soiling pre clean with disinfection wipes 3 After any pre cleaning lightly soak a paper tissue or soft cloth in a mild aldehyde free disinfection and cleaning solution bactericidal and fungicidal and use it to clean disinfect components VDW recommends mikrozid AF wipes manufactured by Sch lke 4 Thoroughly disinfect surfaces with a soaked wipe min 30 seconds making sure the entire surface is wetted and allow to act contact time gt 30 minutes If large surfaces have to be treated use more than one wipe where necessary If you use a disinfectant in the form of
31. ory reset see Section 11 1 If calibration has been inter rupted calibrate the handpiece again to rule out the possibility of a motor fault 2 Clean and lubricate the contra angle 3 Start the calibration procedure again The device switches off automatically if it overheats Allow the device to cool down until it is cool enough to touch Remove the RECIPROC instru ment with pliers by rotating clockwise carefully Select reverse rotation start the handpiece and rotate the instrument out of the root canal carefully 38 11 2 Error Messages LED Zustand Possible error Remedy Total system failure 1 Perform a factory reset see Section 11 The battery is flat 2 Charge the battery The motor has 9 1 Wait a few minutes overheated 2 Press the multifunction button 5 9 D BO BE E OC to reactivate the motor Motor hardware failure 4 Perform reset see Section 11 The battery is faulty 5 Send the device to a VDW authorised service partner General hardware failure 6 Perform reset see Section 11 gt The sensor of the 1 Perform reset see Section 11 ON OFF button is not working properly 5 The Bluetooth 8 Perform reset see Section 11 connection is not working correctly 5 It was not possible to 9 First remedy complete the calibration 1 Lubricate and clean the contra I procedure angle 2 Start the calibration procedure again 39 Second remedy 1
32. p New Profile of your home screen VDW CONNECT 3 Enter a name for your profile and tap Save 4 Your user profile has been created and appears on the navigation bar All the settings that you proceed to make in the VDW CONNECT app are automatically assigned to that profile 32 10 6 2 Delete User Profile and Change Profile Name Before you delete a user profile or change the profile name switch to any other user profile 1 Tap Settings on the navi 2 Tap and hold the desired 3 Perform the desired action gation bar of your home profile until the Edit pen screen change profile name and the Garbage bin symbol delete appear 10 7 Settings In Settings you have the option of selecting the language of the app defining the units of torque and speed and the option Multifunction Button 10 7 1 Language 1 Tap Settings on the navi 2 Select the desired user 3 Select Language and then gation bar of your home profile the desired language screen 33 10 7 2 Units 1 Tap Settings on the navi 2 Select the desired user 3 Select Unit and then the gation bar of your home profile desired unit screen 10 7 3 Option Multifunction Button The option Multifunction Button enables you to switch to the next file within a sequence by pressing the multifunction button without having to operate the iPad 1 Tap Settings on the navi 2 Select the desired user 3 Select Multifunction Button gation
33. pped The ON OFF button is blocked Briefly press the handpiece mul during preparation or faulty tifunction button once to stop the motor Start and stop the motor again If the error has not been re medied contact VDW GmbH or an VDW authorised service partner The handpiece cannot be e The battery is completely flat e Connect handpiece to charger switched on all LEDs off e The handpiece no longer res e Perform reset see Section ponds the LEDs are lit but the 11 The motor automatically motor does not respond when switches to ready mode the button is pressed e The multifunction button is e Send the device to VDW GmbH faulty or an authorised service partner Problem The handpiece cannot be connec ted to the iPad The contra angle cannot be calibrated Handpiece is getting hot A RECIPROC instrument has become jammed in the root canal A rotary instrument has become jammed in the root canal 37 Possible error The Bluetooth connection has failed The calibration procedure may have been interrupted by increased resistance in the contra angle Overheating Treatment was not performed properly Treatment was not performed properly Remedy iPad 1 Activate Bluetooth on your iPad under Settings 2 Sign off the connected VDW CONNECT devices 3 Perform a reboot on your iPad 4 Re connect your VDW CONNECT devices again by use of the VDW CONNECT app Handpiece Perform a fact
34. s have been performed and that the device complies with the relevant laws and regulations Full performance capability of VDW CONNECT Drive is covered by a 12 month warranty and that of the contra angle is covered by a 24 month warranty that commences on the date of delivery to the customer as indicated on the delivery documents bearing the serial number of the product issued by the seller upon sale Only within the term of the warranty is the customer entitled to warranty services and only on condition that he informs VDW GmbH of the defect in writing within two months after the date when the defect was discovered In the event of a substantiated claim the repair will be performed as soon as possible by VDW s Technical Service or a VDW authorised service partner This warranty only covers the exchange or repair of individual components or parts that are affected by manufacturing defects The costs incurred by the dental dealer s technical personnel for visiting the customer and the customer s cost of packaging will not be reimbursed by VDW GmbH The customer is not entitled to file claims with VDW GmbH that go beyond repair e g indemnity claims This warranty does not cover any compensation for direct or indirect personal injury or damage to property of whatever nature The customer is not entitled to demand compensation for device outage times The warranty does not cover losses where VDW GmbH produces evidence that they have be
35. s with regard to electromagnetic compatibility EMC and must be installed and operated in strict compliance with the EMC information In particular do not use the device in the vicinity of fluorescent lamps radio transmitters remote controls portable or mobile RF communication devices even if they meet CISPR 8 requirements Do not charge operate or store at high temperatures Comply with the specified operating and storage conditions Do not position VDW CONNECT Drive in such a way as to make it difficult to disconnect the charge adapter A 4 3 During Treatment e Gloves and a rubber dam are compulsory during treatment e f irregularities should occur in the device during treatment switch it off Contact VDW or your VDW authorised service partner 4 4 Battery e For charging purposes always use the original charger with the charging cable Use of non original chargers jeopardises the safety of both patient and user e f liquid should emerge from the handpiece the batteries may be leaking In such a case stop using the device immediately and contact VDW or your VDW authorised service partner e Never open the device yourself Opening the device voids the warranty Contact VDW or your VDW authorised service partner e A device with a faulty battery must not be sent by air freight see Section 4 11 4 5 Contra angle e Never press the contra angle pushbutton during use or if it is coming to a stop This will lead to det
36. serves the right to change the information and data contained in these instructions for use without prior notice asal VDW GmbH Bayerwaldstr 15 81737 Munich Germany Phone 49 89 62734 0 Fax 49 89 62734 304 www vdw dental com e service vdw dental com Table of Contents 1 1 1 1 2 4 1 4 2 4 3 4 4 4 5 4 6 4 7 4 8 4 9 4 10 4 11 Symbols Used In These Instructions for Use On the Product Packaging Intended Use Contraindications Warnings User Ambient Conditions During Treatment Battery Contra angle Root Canal Instruments iPad Accessories Apex Locator Repairs and Defects Transport Precautions VDW CONNECT App Adverse Reactions Step by Step Instructions c co oo co Oo NNN N h ch vch O O o 11 11 11 8 1 8 2 8 3 8 4 8 5 8 6 10 10 1 10 1 1 JE 10 1 3 10 1 4 10 1 9 10 2 10 2 1 10 2 2 10 23 10 2 4 10 3 10 341 10 9 2 10 5 3 10 3 4 VDW CONNECT Drive at a Glance 11 LEDs and Buttons LED Colour Statuses Standby Mode Acoustic Signals RECIPROC REVERSE Comfort Function Battery Care Operation without VDW CONNECT App Operation with VDW CONNECT App and iPad User Navigation of the VDW CONNECT App at a Glance Symbols in the VDW CONNECT App Home Screen Navigation Bar Control Panel Shortcuts and Favourites Status Bar Connect Disconnect and Customise Handpiece Connect Handpiece Disconnect Ha
37. stem instrument sequence or Instructions for i i structions for Use instrument has not been selected as a favourite Information about the manufacturer Reverse rotation in rotary mode 3I EDEN and the app Settings Difficult canal Ncm User profile e Contra angle Calibration Edit RECIPROC REVERSE Comfort function Bluetooth connected Bluetooth not connected Delete profile 17 10 1 2 Home Screen When you start the VDW CONNECT app on your iPad the following home screen opens It is divided into three navigation areas E 20 D Info User Manual Tj TS VDW CONNECT e ChECIPROC o Drie B Navigation bar Status bar nfo about app connected devices etc Connected handpieces User profiles Connection status Instructions for Use Current instrument setting Settings Handpiece battery charge status O Control panel Shortcuts and favourites for instrument systems sequences and instruments 18 10 1 3 Navigation Bar Pad E D Info User Manual T me VDW CONNECT Settings Q Info Instructions for Use a Manufacturer s contact data version of the Ci Instructions for Use in your selected app and all connected devices language wai Sidi wii Po ee oss Ua ke gea yo Cte far oleh E uet ere User profile Settings O Select user profiles and create new ones OG Select units language and option Multifunction Button Deltaun Prolia J Dr Smith
38. t is no longer subjected to friction the motor comes to a stop Perform steps 1 3 described below If you press the ON OFF switch again the motor runs in reciprocating mode again Perform steps 4 and 5 described below Second signal interrupted beep Clean the instrument in the interim stand Irrigate the canal Check for accessibility with a C PILOT FILE ISO size 10 4 Use a lateral brushing motion towards the coronal end in order to enlarge the canal 5 Then continue with a picking motion wW N 15 8 6 Battery Care Please also follow the charging instructions in the Getting Started brochure and heed the warnings e in Section 4 4 The following instructions will help you to ensure that the battery has a long service life BOE e ifthe battery LED on the handpiece lights up red charge the battery You can continue treatment during the charging process e Charge the battery no more than once a day the battery as soon as the battery LED turns red at the latest when the LED starts flashing red the battery until it is completely charged every time i e until the battery LED turns green e f the battery was completely flat charging can take up to three hours e Continuous operation with the charger connected shortens the life of the battery VDW recommends working without the charging cable connected 9 Operation without VDW CONNECT App WD You will find details on getting s
39. tarted without the app in the Getting Started brochure W e Reciprocating mode is preset by default e The settings for operation without the VDW CONNECT app are solely designed for original RECIPROC instruments In the event of non compliance misuse can occur For working with instrument systems other than RECIPROC the VDW CONNECT app is required e f later on you should decide to work with the free VDW CONNECT app it can be installed at any time All you require is a compatible device e g Apple iPad mini The VDW CONNECT app is available as free download in the App Store 10 Operation with VDW CONNECT App and iPad In this section you will be quickly familiarised with all the setting options of the VDW CONNECT app You can download the VDW CONNECT app free of charge in the App Store Download on the Ki App Store Bep Apple the Apple logo and iPad are trademarks of Apple Inc registered in the U S and other countries App Store is a service mark of Apple Inc 10 1 User Navigation of the VDW CONNECT App at a Glance To enable you to quickly familiarise yourself with the VDW CONNECT app here is a brief overview of the app navigation 16 10 1 1 Symbols in the VDW CONNECT App Symbol Explanation Symbol Explanation A CH o D O WW Close window or delete entry One step back Back to home screen Instrument system instrument sequence or instrument added as a favourite Instrument sy
40. wn Safety and effectiveness have not been established in pregnant women and children T Step by Step Instructions WD You will find practical step by step instructions on getting started in the Getting Started brochure 8 VDW CONNECT Drive at a Glance 8 1 LEDs and Buttons ON OFF button 1 Starts the instrument LED iPad Pairing gt Pairing only possible with VDW CONNECT app and iPad a LED reciprocating mode LED rotary mode Rotary file systems only possible LED battery status with VDW CONNECT app and iPad Multifunction button e Handpiece activation e Connect handpiece to iPad e Reset 10 s Figure 2 Your handpiece at a glance e Reset to default settings 20 s W The handpiece switches into standby mode automatically see chapter 8 3 You do not need a classic ON OFF switch 12 8 2 LED Colour Statuses The various LEDs buttons indicate the specific status of the handpiece by changing colours Symbol Button LED Status Meaning ON OFF button for starting 1 the instrument Handpiece ready for operation NIZ 1 Flashes every 3s Handpiece in energy saving mode Calibration when using the VDW CONNECT app with iPad 1 Flashes ready for calibration Continuously lit contra angle is being calibrated Possible error see Section 11 2 Handpiece is connecting to the iPad fc LED iPad Pairing 9 Flashes LED continuously lit handpi
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