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Cleaning, Disinfection and Sterilization

F1902142.EN / 05 / 2015 / updated 02/2016

61/74

7.4.5

Sterilization

N°

Operation

Remarks

A

Packaging

Shrink wrap the contra-
angle in sterile barrier 
packages.

Conforming to EN 868-5.

B

Sterilization

Sterilize at a maximum 
sterilization temperature 
of 134°C (274°F).
See 

7.4.5.1 Approved 

Sterilization Procedure

.

Clean and disinfect before sterilization. The 
contra-angle should also be lubricated before 
sterilization.

Make sure you only use dry sterile items.

Use a sterilization temperature with tolerance in 
compliance with ISO 17665.

Please refer to the information provided by the device manufacturer.

Содержание X-SMART IQ

Страница 1: ...User Manual EN...

Страница 2: ...2 74 F1902142 EN 05 2015 updated 02 2016 PAGE INTENTIONALLY LEFT BLANK...

Страница 3: ...setting the Volume 18 6 5 2 Activating the AssistiveTouch 19 6 5 3 Activating the WiFi 21 6 5 4 Activating the Bluetooth 21 6 5 5 Installing and Updating the DENTSPLY ENDO IQ Application 22 6 5 5 1 Fi...

Страница 4: ...ation and Settings 41 6 7 5 2 Start Treatment 42 6 7 5 3 Start and Record Treatment 43 6 7 6 Treatment Reports 44 6 7 6 1 Treatment Details 45 6 7 6 2 Treatment Notes 46 6 7 7 Customize File Sequences...

Страница 5: ...pdated 02 2016 5 74 8 Technical Characteristics 63 9 Motor Handpiece Error Code 65 10 Troubleshooting 67 11 Warranty 69 11 1 Exclusion of Liability 70 12 Disposal of the Product 71 13 Identification o...

Страница 6: ...ou wish to have a printed one we will be happy to send you a copy free of charge within 7 calendar days to any address in the EU To order simply send your request to info dentsplymaillefer com The Use...

Страница 7: ...2142 EN 05 2015 updated 02 2016 7 74 1 Indications for Use X SMART IQ is a cordless motor handpiece with torque control used for driving files in both reciprocating and continuous rotation mode during...

Страница 8: ...r other electrical equipment and has been cautioned against the use of small electrical appliances such as electric shavers hair dryers etc X SMART IQ must not be used Do not use X SMART IQ for implan...

Страница 9: ...eration of equipment in the vicinity If this happens the interference should be reduced by reorienting or repositioning the device or by screening off the immediate environment The electromagnetic rad...

Страница 10: ...f non original chargers jeopardizes the safety of the patient and user If liquid should emerge from the motor handpiece the batteries may be leaking In this event stop using the device immediately and...

Страница 11: ...ndpiece support cover Hygiene measures to prevent cross contamination are absolutely essential Dentsply Maillefer recommends using the iPad protective case as indicated in 6 5 6 Setting up the Complet...

Страница 12: ...NTSPLY ENDO IQ does not replace your Dental Practice Management Software It is strongly recommended that all open applications are closed before launching the DENTSPLY ENDO IQ application Accessories...

Страница 13: ...ctive battery Standards and regulations that apply to the transport of X SMART IQ Air freight Land freight Intact device or defective device with intact battery UN 3481 Lithium batteries in equipment...

Страница 14: ...Read the following precautions before use Please check the compatibility of your DENTSPLY ENDO IQ application before updating the iPad operating system Always install the latest version of the DENTSP...

Страница 15: ...Adverse Reactions F1902142 EN 05 2015 updated 02 2016 15 74 5 Adverse Reactions There are no known adverse reactions Safety and effectiveness have not been established in pregnant women and children...

Страница 16: ...kage See 6 3 Package Contents 6 1 Document Symbols 6 2 DENTSPLY ENDO IQ Application Compatibility Symbol Identification Consult instructions for use If the instructions are not followed properly opera...

Страница 17: ...mponents presented below are available in all kits F i l e s F i l e s Getting Started Guide Ju a few images to help you set up your motor easily and get the mo out of it Spray nozzle used for lubrica...

Страница 18: ...lowing components are not included in the kit 6 5 System Setup 6 5 1 Turning on the iPad and setting the Volume iPad with iOS app not part of the kit N Action A Turn on the iPad B Adjust the volume to...

Страница 19: ...e AssistiveTouch feature replaces the actions of the iPad Home button which is not accessible when in the protective case To activate the AssistiveTouch N Key Action A Select Settings B Select General...

Страница 20: ...0 74 F1902142 EN 05 2015 updated 02 2016 To press the Home button with AssistiveTouch N Action A Tap on the virtual home button B Select HOME It is also possible to use the 4 fingers to swipe in and t...

Страница 21: ...6 5 4 Activating the Bluetooth You need to activate Bluetooth to connect the motor handpiece to the iPad N Key Action A Select Settings B Select WiFi C Set WiFi to ON D Select your network and enter y...

Страница 22: ...ularly by synchronizing with iTunes N Key Action A Connect to the App Store B Search and download the DENTSPLY ENDO IQ application To download the DENTSPLY ENDO IQ application you need an Apple ID If...

Страница 23: ...Action A Enclose the iPad in the protective case and fit the rubber plugs Pay attention to the iPad orientation In case of error use the red key to open the protective case B Separate the motor handpi...

Страница 24: ...assembly on a steady surface Multiple configurations are possible D Insert the contra angle on the motor handpiece Turn off the motor before connecting or disconnecting the contra angle E Place the mo...

Страница 25: ...a Bluetooth See 6 7 3 Connecting the Motor Handpiece Awakens the motor handpiece The motor handpiece does not turn off it automatically switches to Stand by mode See 6 6 1 4 Stand by Mode Advance to t...

Страница 26: ...g Motor handpiece turning in reverse Or motor handpiece locked Error detected See 10 Troubleshooting Bluetooth ON motor handpiece ready to be connected See 6 7 3 Connecting the Motor Handpiece When th...

Страница 27: ...r handpiece in stand alone mode See 6 6 3 Stand alone mode operation without the DENTSPLY ENDO IQ Application Reciprocating motion mode active Continuous rotation mode active Device completely charged...

Страница 28: ...ece For acoustic signals see 6 6 1 3 Description of the Sounds Button LED State Description a Mode Explanation AutoRev OFF If the applied torque on the motor handpiece is higher than the maximum defin...

Страница 29: ...ching to forward rotation Battery charge level One short beep when the battery charge level is low Three second beep when the battery charge level is critical Motor START STOP button A short beep when...

Страница 30: ...charging can take up to six hours Continuous operation with the charger connected shortens the lifetime of the battery Dentsply Maillefer recommends working without the charging cable connected 6 6 2...

Страница 31: ...Q application See 6 7 3 Connecting the Motor Handpiece Choose one of the available Stand alone modes See 6 7 5 1 Motor Handpiece Information and Settings N Action A Press the pushbutton 3 and pull out...

Страница 32: ...nces A user management see 6 7 4 Interface Presentation Motor handpiece management via the Bluetooth connection to the device The application is available in the App Store See 6 5 5 Installing and Upd...

Страница 33: ...nected as this user N Key Action A Edit the profile See 6 7 4 Interface Presentation Enter a user name and an email address Email address is optional To add a new user follow the steps below B Log out...

Страница 34: ...n button until the Bluetooth LED blinks Bluetooth LED blinks blue see 6 6 1 1 Description of the LED Colors B Wait until the motor handpiece is visible on the DENTSPLY ENDO IQ application See 10 Troub...

Страница 35: ...4 C Select the corresponding motor handpiece serial number from the pop up The serial number 2 can be found at the back of the motor handpiece When the motor handpiece is connected The icon 3 appears...

Страница 36: ...NTSPLY ENDO IQ application The second motor handpiece can be recognized by the green Bluetooth LED and the following icon on the DENTSPLY ENDO IQ application It is not possible to connect more than tw...

Страница 37: ...ons F1902142 EN 05 2015 updated 02 2016 37 74 6 7 3 2 Disconnecting the Motor Handpiece N Action A Click on the icon 1 B Select Disconnect 2 and confirm the operation The motor handpiece disappears fr...

Страница 38: ...up menu that contains Parameters Statistics and About To edit the user profile User Manual To log out and change user See 6 7 5 2 Start Treatment See 6 7 5 3 Start and Record Treatment See 6 7 6 Trea...

Страница 39: ...omize File Sequences Torque recording graph see 6 7 5 2 Start Treatment Calibration see 6 7 5 2 Start Treatment Create and send a PDF report by email see 6 7 6 Treatment Reports Edit a file a sequence...

Страница 40: ...6 6 3 Stand alone mode operation without the DENTSPLY ENDO IQ Application 1 Log in as a user 2 Connect the motor handpiece 3 Select Start Treatment 4 Select a file sequence See 6 7 5 2 Start Treatment...

Страница 41: ...or the motor handpiece reciprocating motion mode and continuous rotation modes To share system status with a Technical support centre To disconnect the motor handpiece See 6 7 3 2 Disconnecting the Mo...

Страница 42: ...bration is recommended before each treatment Follow the procedure on the screen To set auto reverse function See 6 6 1 2 The Auto Reverse AutoRev Functionality Click or swipe to move to next file or p...

Страница 43: ...Treatment are also applicable to Start and Record Treatment To assign the current treatment to a patient To select the tooth on which the treatment is being carried out and add treatment notes See 6...

Страница 44: ...sort patients by treatment date To search for a patient by name Click on a patient to display additional functions To display additional information on the treatment See 6 7 6 1 Treatment Details To d...

Страница 45: ...c information for the patient and specific information for the associated treatment To delete the treatment To create and send a PDF report by email To review your treatment notes See 6 7 6 2 Treatmen...

Страница 46: ...2015 updated 02 2016 6 7 6 2 Treatment Notes Treated tooth To save the treatments Information related to the treatments Canal type Length Obturation Method File and Note To delete the treatment Takes...

Страница 47: ...used sequences Sequences created by the user Standard file sequences provided by Dentsply Maillefer Standard file sequences provided by VDW The Customize File Sequences screen allows you to Review all...

Страница 48: ...is is of the utmost importance in order to avoid misusing reciprocating files and continuous rotary files Torque and speed values are liable to modification by the file manufacturers without notice Th...

Страница 49: ...6 1 2 The Auto Reverse AutoRev Functionality File name Name of the file system Name of the manufacturer File purpose No File Type Shaping Glide Path Cavity Access or Retreatment Maximum torque Indicat...

Страница 50: ...edited A custom file can only be deleted if not used in any sequence Click on the arrow to add the file in your sequence Name of the file sequence Save your sequence Delete the selected file from the...

Страница 51: ...05 2015 updated 02 2016 51 74 6 8 Storing and charging the Motor Handpiece N Action A Store the motor handpiece in the motor handpiece holder B Plug in the motor charger C Fit the motor handpiece cove...

Страница 52: ...inspections are performed on the equipment disinfector sterilizer and that the validated parameters are maintained in every cycle Comply with your national guidelines standards and requirements for cl...

Страница 53: ...andpiece to wipe down disinfection ensure that the charging cable is not connected and that the charging socket is closed Please refer to the manufacturer s information on use of the disinfectant N Ac...

Страница 54: ...Cleaning Disinfection and Sterilization 54 74 F1902142 EN 05 2015 updated 02 2016 Spray nozzle Charging cable iPad protective case Motor handpiece Motor handpiece cover Motor handpiece support...

Страница 55: ...processing being the preferable measure Below you will find instructions concerning device based and manual reprocessing lubrication and sterilization Always start with preparation at the point of use...

Страница 56: ...he contra angle Transport is not subject to any special requirements B Manual pre cleaning In the event of heavy soiling pre clean with disinfection wipes immediately after use Manual pre cleaning is...

Страница 57: ...Use a cleaning tool brush B Manual disinfection Thoroughly disinfect surfaces with a soaked wipe making sure the entire surface is wet and allow to act exposure time 30 minutes For disinfection purpo...

Страница 58: ...holding time 5 min Use washer disinfector conforming to EN ISO 15883 e g Belimed WD programme neutral Use cleaning solution e g 0 5 v v deconex 24 LIQ Borer Chemie Use neutralizing solution e g 0 25 v...

Страница 59: ...o the motor handpiece Contamination of the motor handpiece with oil can damage it and have a negative impact on safety when it is being operated Lubricate the contra angle immediately after thermal di...

Страница 60: ...ing and disinfection process and start the lubrication process again E Wipe the contra angle with a paper tissue or a soft cloth Always calibrate the motor handpiece when the contra angle has been lub...

Страница 61: ...B Sterilization Sterilize at a maximum sterilization temperature of 134 C 274 F See 7 4 5 1 Approved Sterilization Procedure Clean and disinfect before sterilization The contra angle should also be lu...

Страница 62: ...sterilization Steam sterilization in accordance with EN 13060 or EN 285 The fast sterilization procedure and the sterilization procedure with non packaged accessories are not permissible In addition...

Страница 63: ...with rotary and reciprocating files with a 2 35 mm shaft conforming to ISO 1797 1 2011 Type 1 Power supply Lithium ion battery 3 6 V 2 000 mAh Charger power supply 100 240 VAC Frequency 50 60 Hz Charg...

Страница 64: ...ccording to MDD 93 42 EEC Annex IX Conditions for transport and storage Ambient temperature 20 C 50 C 4 F 122 F Relative humidity 20 80 non condensing at 40 C 104 F Atmospheric pressure 50 kPa 106 kPa...

Страница 65: ...handpiece with a Factory Reset see 6 6 1 Description of the Motor Handpiece Battery empty Charge the battery see 6 8 Storing and charging the Motor Handpiece Motor overheating Wait for a few minutes...

Страница 66: ...andpiece Calibration failed Lubricate the contra angle see 7 4 4 Lubrication of the Contra Angle and perform the calibration again If the error persists try to replace the contra angle and perform the...

Страница 67: ...ce center The handpiece cannot be switched on The battery is completely flat all LEDs off Connect the motor handpiece to charger see 6 8 Storing and charging the Motor Handpiece The handpiece no longe...

Страница 68: ...upted by increased resistance in the contra angle 1 If calibration has been interrupted calibrate the motor handpiece again to rule out the possibility of a motor fault 2 Clean and lubricate the contr...

Страница 69: ...sible by the Technical Equipment Service of Dentsply Maillefer or a service partner authorized by Dentsply Maillefer This warranty only covers the exchange or repair of individual components or parts...

Страница 70: ...ustomer purchased the product especially ones filed with the dental dealer shall remain unaffected 11 1 Exclusion of Liability In the following cases the manufacturer declines all liability Use of X S...

Страница 71: ...ectrical equipment and batteries Specialist dental dealers will be pleased to provide you with country specific information concerning disposal Make sure the product or battery is not mixed with other...

Страница 72: ...er to instruction manual booklet Electronic instruction for use Date of manufacture Manufacturer Class II equipment Type BF applied part Recycling PLEASE DO NOT THROW AWAY This product and all its com...

Страница 73: ...not replaced CE Mark Alternate current Temperature limit Humidity limitation Atmospheric pressure limitation Keep away from rain Fragile handle with care Accessory Use by date Do not sterilize Do not...

Страница 74: ...F1902142 EN 05 2015 updated 02 2016 www dentsplymaillefer com Maillefer Instruments Holding S rl Chemin du Verger 3 CH 1338 Ballaigues Switzerland email info dentsplymaillefer com...

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