Bien Air iOptima Instructions For Use Manual
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Bien Air iOptima Instructions For Use Manual

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iOptima
INT
iOptima
ENG INSTRUCTIONS FOR USE.
other languages available on www.bienair.com/ifu
REF 2100279-0004/2018.06

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Summary of Contents for Bien Air iOptima

  • Page 1 ENG INSTRUCTIONS FOR USE. other languages available on www.bienair.com/ifu REF 2100279-0004/2018.06...
  • Page 2 Set iOptima REF 1700544-001 REF 1600926-001 REF 1600677-001 REF 1600762-001 REF 1501938-001 Set iOptima REF 1700547-001 REF 1600926-001 REF 1600762-001 REF 1501938-001 Options REF 1600036-006 REF 2100279-0004/2018.06 © Bien-Air Dental...
  • Page 3 REF 2100279-0004/2018.06 © Bien-Air Dental...
  • Page 4 Set iOptima REF 1700704-001 REF 1502475-001 REF 1600677-001 REF 1600809-001 REF 1601074-001 REF 1500666-001 REF 1502568-001 REF 1300067-001 Set iOptima REF 1700705-001 REF 1502475-001 REF 1600677-001 REF 1600809-001 REF 1601075-001 REF 1500666-001 REF 1502568-001 REF 1300067-001 REF 2100279-0004/2018.06 © Bien-Air Dental...
  • Page 5 Set iOptima REF 1700730-001 REF 1601074-001 REF 1500666-001 REF 1600809-001 REF 1502568-001 REF 1300067-001 Set iOptima REF 1700731-001 REF 1601075-001 REF 1500666-001 REF 1600809-001 REF 1502568-001 REF 1300067-001 Options REF 1502620-001 REF 1502621-001 REF 1502622-001 REF 1502623-001 REF 1502567-001 REF 2100279-0004/2018.06 © Bien-Air Dental...

  • Page 6: Table Of Contents

    Interface overview......... 19 12 Interface overview......... 35 iOptima application................19 12.1 iOptima application................35 Sound alerts ..................19 12.2 Sound alerts ..................35 iPod and iOptima connection / disconnection conditions..20 12.3 iPod/iPad and iOptima connection / disconnection conditions .................... 36...
  • Page 7 ..38 13 Getting started ..........39 13.1 Back up data..................39 13.2 Use of the Touch screen..............39 13.3 Launch iOptima app ................. 40 13.4 Welcome screen and disclaimer ..........41 13.5 Information ..................42 13.6 Settings ....................43 13.7 iOptima app update ................

  • Page 9: Ioptima Description

    Rx Only...

  • Page 10: Symbols

    1 Symbols 1.1 Description of symbols for iOptima unit Symbol Description Symbol Description RF emitting device (Interference may occur in the CE Marking with number of the notified body. vicinity of equipment marked with this symbol). Manufacturer. Alternating current. Reference number.

  • Page 11: Description Of Symbols For Ioptima Accessories

    1.2 Description of symbols for iOptima accessories Symbol Description Symbol Description Separate collection of electric and electronic equip- CE Marking with number of the notified body. ment. Manufacturer. Serial number. Electrical safety. Reference number. Applied part type B.

  • Page 12: Identification, Intended Use And Notation

    FIG. 1 lightning connector. iOptima system connected to an iPod that controls a MX2 motor. The unit provides power to the iPod device as soon as it is Any use other than that for which this product is intended is connected.

  • Page 13: Notation

    2.3 Notation • A, B, C, etc. NOTES Text preceded by a letter indicates a procedure to be carried out step-by-step.  • The technical specifications, illustrations and dimensions Indicates a procedure result. contained in these instructions are given only as a guide. They •...

  • Page 14: Warnings & Precautions Of Use

    (anesthetic gas). NOTES  CAUTION To prevent any risk of electric shock, the iOptima unit must be The predefined parameters may be subject to modification connected only to a power supply network provided with a without notice. protective earth.

  • Page 15: Description

    4 Description 4.1 iOptima system overview The iOptima system consists of: • iOptima unit (3) with docking station for iPod (4); • A MX2 micromotor (12) and MX2 hose (10, A); • A pneumatic 4-way connection input (6, B); • A power supply (2) and plug cord (C).

  • Page 16: Ioptima System Table

    4.2 iOptima system table Summary of the iOptima functions and technological features. CA ENDO Product Device Technology Motor Restorative Endodontics Surgery option iOptima iPod DMX2 4.3 Set supplied 4.4 Options 4.3.1 iOptima system Designation REF number Spraynet, cleaning spray 500 ml, box of 6 cans...

  • Page 17: Technical Data

    500 hPa to 1060 hPa pressure 1060 hPa 0 to 3'048 m Altitude (0 to 10'000 ft)  CAUTION Do not use iOptima outside the range of operating temperature. Classification Class IIa in accordance with European Directive 93/42/EEC concerning medical devices.

  • Page 18: Environmental Protection And Information For Disposal

    Bien-Air Dental SA. The conditions for and restrictions on use set by Apple must be iOptima should not be used adjacent to or stacked with other respected (jailbreak, hardware modification, etc.). equipment. If adjacent or stacked use is necessary, iOptima...
  • Page 19 Guidance and manufacturer’s declaration - electromagnetic emissions iOptima is intended for use in the electromagnetic environment specified below. The customer or the user of iOptima should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance iOptima uses RF energy only for its internal function.
  • Page 20 TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an elec- tromagnetic site survey should be considered. If the measured field strength in the location in which the iOptima is used exceeds the applicable RF compliance level above, the iOptima should be observed to verify normal operation.
  • Page 21 Recommended separation distances between portable and mobile RF communications equipment and the iOptima The iOptima is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the iOptima can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the iOptima as recommended below, according to the maximum output power of the communications equipment.

  • Page 22: Installation

    Note 2  CAUTION FIG. 1 Ensure that the power switch (3) is off «O». A. Place the iOptima on a flat surface capable of bearing its  weight. CAUTION  Before connecting the MX2 cable ensure that all o-rings are CAUTION correctly fitted and connectors are clean of dust.
  • Page 23 10 and only use the power supply provided with the hose sleeve, by matching the connector and the coupling; iOptima. In order to maintain warranty, this unit must be installed • Tighten (CW). with the greatest care. Follow all the necessary instructions. Pro- tect the unit from direct sunlight and dust.

  • Page 24: Interface Overview

    FIG. 1 (iPod Touch®) 6 Interface overview 6.1 iOptima application 6.2 Sound alerts The iOptima application allows to carry out endodontics and restorative dentistry operations. 6.1.1 Compatibility Sound alert Description Entering in endodontics or restorative The iOptima application is compatible with iPod from 6th mode generation.

  • Page 25: Ipod And Ioptima Connection / Disconnection Conditions

    6.3 iPod and iOptima connection / 6.3.3 iOptima unit switched ON disconnection conditions If the iOptima app is running and the iPod plugged to the iOptima (switch ON): 6.3.1 Disconnection • The iPod will charge up (even if the app is not running);...

  • Page 27: Ioptima Description

    description...

  • Page 28: Symbols

    7 Symbols 7.1 Description of symbols for iOptima Symbol Description Symbol Description RF emitting device (Interference may occur in the CE Marking with number of the notified body. vicinity of equipment marked with this symbol). Manufacturer. Alternating current. Reference number.

  • Page 29: Accessories

    7.2 Description of symbols for iOptima accessories Symbol Description Symbol Description Separate collection of electric and electronic equip- CE Marking with number of the notified body. ment. Manufacturer. Serial number. Electrical safety. Reference number. Applied part type B.

  • Page 30: Identification, Intended Use And Notation

    The restorative and endodontics parameters are defined before operation using the iOptima application installed on the iPod/ iPad. The iOptima application indicates the operation steps, the ratio of the handpiece, tool speed, torque value, light intensity, footpedal mode and the micromotor rotation direction. iOptima application is compatible with Apple iOS operating system.

  • Page 31: Notation

    8.3 Notation • A, B, C, etc. NOTES Text preceded by a letter indicates a procedure to be carried out step-by-step.  • The technical specifications, illustrations and dimensions Indicates a procedure result. contained in these instructions are given only as a guide. They •...

  • Page 32: Warnings & Precautions Of Use

    NOTES atmosphere (anesthetic gas).  CAUTION The predefined parameters may be subject to modification To prevent any risk of electric shock, the iOptima unit must be without notice. connected only to a power supply network provided with a protective earth.

  • Page 33: Description

    • A unit as a docking station (2) for iPod/iPad device. • The iPod/iPad provide the user interface to the iOptima system, except speed reference input. • The electronic board (1), integrated in the dental unit system, is in charge to drive the micromotor (MX2) and communicate with the interface through the Lightning connector.

  • Page 34: Set Supplied

    10.3 Set supplied iOptima set REF 1700730-001 10.3.1 iOptima system Designation REF number MX2 Micromotor hose (1x) 1600809-001 iOptima set REF 1700704-001 Power supply reset switch 1502568-001 Designation REF number Power supply PMP90 (1x) 1500666-001 1502475-001 iOptima iDevice fixation (1x) 3P cable system, US/Asia, length 2.00 m (1x)

  • Page 35: Technical Data

    1060 hPa 0 to 3'000 m Altitude (0 to 9842 ft)  CAUTION Do not use iOptima outside the range of operating temperature. Classification Class IIa in accordance with European Directive 93/42/EEC concerning medical devices. Electric insulation class Class I per IEC 60601-1 (apparatus protected against electric...

  • Page 36: Environmental Protection And Information For Disposal

    Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the iOptima , including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • Page 37 Guidance and manufacturer’s declaration – Electromagnetic immunity The iOptima INT is intended for use in the electromagnetic environment specified below. The customer or the user of the iOptima INT must ensure that it is actually used in such an environment.
  • Page 38 TV broadcasts cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an elec- tromagnetic site survey should be considered. If the measured field strength in the location in which the iOptima INT is used exceeds the RF compliance level mentioned above, the iOptima INT should be observed to verify that it is operating normally.

  • Page 39: Installation

    11 Installation 11.1 Install the iOptima app A. Open the "App Store". B. Search the iOptima application. C. Install the iOptima application designed by Bien-Air Dental. Note 1 11.2 Install the iOptima system Refer to the iOptima installation manual. Note 2...

  • Page 40: Interface Overview

    FIG. 1 (iPod Touch®) 12 Interface overview 12.1 iOptima application 12.2 Sound alerts The iOptima application allows to carry out endodontics and restorative dentistry operations. 12.1.1 Compatibility Sound alert Description Entering in endodontics or restorative The iOptima application is compatible with iPod from 6th mode generation and iPad from 4th generation.

  • Page 41: Ipod/Ipad And Ioptima Int Connection / Disconnection Conditions

    12.3 iPod/iPad and iOptima connection / 12.3.3 iOptima unit switched ON disconnection conditions If the iOptima app is running and the iPod/iPad plugged to the iOptima (switch ON): 12.3.1 Disconnection • The iPod/iPad will charge up (even if the app is not running);...

  • Page 43: Ioptima/Ioptima Operation

    operation...

  • Page 44: Getting Started

    FIG. 5 13 Getting started 13.1 Back up data 13.2.1 Display onscreen keyboard Use iTunes or iCloud to automatically back up your iOptima FIG. 5 application user-defined settings. • Tap a text field to display the onscreen keyboard; Refer to Apple's user guide for appropriate use of the iPod/iPad, •...

  • Page 45: Launch Ioptima App

    C. Deactivate all alerts. Refer to Apple's user guide for appropriate use of the iPod/iPad. D. Ensure that the latest application updates have been installed (see chapter “13.7 iOptima app update” on page 43). E. Tap the app icon (5) to launch the iOptima application. Note 2...

  • Page 46: Welcome Screen And Disclaimer

    13.4 Welcome screen and disclaimer FIG. 9 The Welcome screen differs whether using the iOptima or A. To ensure the appropriate working of the iOptima Dental unit, iOptima system and depends on which type of micromotor is make sure to only use your iOptima application with the iOS connected.

  • Page 47: Information

    • Catalogue (4) (opens online catalogue (pdf file)); • Web TV (5) (opens Bien-Air web TV); • About (6) (displays About screen (FIG. 12, 8) with iOptima system and Bien-Air factory information); • Contact us (opens email application with predefined email address iOptima@bienair.com).

  • Page 48: Settings

    FIG. 14 FIG. 15 FIG. 16 FIG. 17 FIG. 18 13.6 Settings 13.7 iOptima app update FIG. 14 FIG. 18 When the application is launched, it will check whether a new A. Tap (1) to access iOptima/iOptima system Settings version is available on the App Store.
  • Page 49 NOTES To modify service engineer settings, please contact a service engineer certified by Bien-Air Dental SA. This function is active only when the iPod/iPad is connected to a Wi-Fi network.

  • Page 50: Operation - Restorative Mode

    . In this Micromotor rotation mode: FORWARD and REVERSE case the iOptima unit automatically lowers the torque in order to Save (customize settings) avoid overheating of the micromotor. Footpedal mode: PROGRESSIVE or ON/OFF mode...
  • Page 51 14.2.3 Light intensity In restorative mode, the air spray is always switched ON by the help of the electro-valve integrated in the iOptima unit. FIG. 7 Slide or tap the appropriate dot to set up the light intensity of the...

  • Page 52: Standard Use - Operating Mode (Start)

    FIG. 10 FIG. 11 FIG. 12 FIG. 13 FIG. 14 14.3 Standard Use - Operating mode (Start) E. Tap the operation type above (3) or below (4) the selected operation type to navigate to the operation respectively preceding or FIG. 10 following the current one in the predefined operation list.
  • Page 53 FIG. 17 Swipe left to restore or delete. Note 16 - 17 If using iOptima system, each time you pull a motor from a holder, the operative mode previously used with that motor is dis- played by default (only from Home page).

  • Page 54: Create New Operations (User-Defined)

    FIG. 20 FIG. 21 FIG. 22 FIG. 23 14.5 Create new operations (user-defined) FIG. 20 A. From the operative screen, tap Settings to open the Operations screen. FIG. 21 B. Tap to create a new operation type.  The Operations screen opens. Note 19 FIG.
  • Page 55 NOTES Maximum storage of 20 user-defined operations, if reached icon disappears.

  • Page 56: Operation - Endodontics Mode

    AUTO-FORWARD operative screen displays the overheating symbol . In this Save (to customize settings) case the iOptima unit lowers the torque automatically in order to Footpedal mode: PROGRESSIVE or ON/OFF mode avoid overheating of the micromotor. Light intensity To restore 100% torque, allow the motor to idle or stop for a few Handpiece ratio seconds.
  • Page 57 Note 7 - 8 «IMPORTANT WARNING: If instruments other than the 8:1 Bien-Air or the 1:1 Bien-Air Dental are used with the iOptima, please note that the 15.2.4 Footpedal mode displayed torque values cannot be guaranteed any longer (they repre- sent a purely indicative information).

  • Page 58: Standard Use - Operating Mode (Start)

    FIG. 9 FIG. 10 FIG. 11 FIG. 12 FIG. 13  15.2.5 Micromotor rotation direction The app navigates back to the operative screen, FIG. 14. E. Press the dental unit pedal to switch on the micromotor. FIG. 9  Tap to select the rotation mode of the micromotor: CAUTION •...
  • Page 59 (alternate medium beeps). FIG. 18 D. Customize the file system settings: If using iOptima system, each time you pull a motor from a holder, the operative mode previously used with that motor is dis- • tap any file (4) to open the File screen and modify motor played by default (only from Home page).

  • Page 60: Add, Sort Or Remove Files

    FIG. 19 FIG. 20 FIG. 21 FIG. 22 FIG. 23 15.5 Add, sort or remove files Note 18 15.5.1 Add new files FIG. 19 A. Tap in the Add new file field to open the File screen. FIG. 20 - FIG. 21 B.

  • Page 61: Restore (Default) And Delete (User-Defined) Systems

    Default manufacturer files are represented by the symbol FIG. 26 Predefined endo file systems foreseeing the reciprocating Dentsply Sirona movement need activation on the iOptima system. In case the Note 21 movement wasn’t previosuly activated, taping it leads to the acti- vation page.

  • Page 62: Create New Brands And Systems

    E. Tap Add new file (4), refer to chapter “15.5.1 Add new files” on FIG. 33 page 55. F. Tap the icons (6) to set the iOptima unit parameters: A. Swipe left on a user-defined brand. • Handpiece ratio ...

  • Page 63: Ca Endo / Reciproq Option

    FIG. 36 15.8 CA ENDO / Reciproq option Predefined endo file systems foreseeing the reciprocating NOTES movement need activation on the iOptima system. In case the movement wasn’t previously activated, tapping it leads to the activation page. New systems and brands can also be created directly from the system screen.

  • Page 64: List Of Errors & Troubleshooting

    16 List of errors & Troubleshooting 16.1 Safety warning (operating) Warning description Message Cause of warning Action Pedal is pressed when accessing operative page. Pedal remains pressed when Footpedal to be released Please release pedal … acknowledging any system Release footpedal and press it again. notification.

  • Page 65: Device Operating Error

    1. Switch OFF unit drive communication failure 2. Disconnect iPod/iPad device from unit [FailCode] = EC101 : Motor Electrical system fault ! 3. Close iOptima application drive under voltage failure System electrical failure. Please contact 4. Switch unit back ON [FailCode] = EC102 : Motor Bien-Air Dental SA.

  • Page 66: Ios Compatibility Errors (Disclaimer Screen)

    16.3 iOS compatibility errors (disclaimer screen), Color iOS version (identifier digit change) Text version Restriction (recommendations) • None. Currently installed iOS x.y.z text sec- Green • Currently installed iOS is identical to No restrictions tion is displayed in green color. iOS verified during app validation.
  • Page 67 NOTES It is imperative to read and understand this IFU before carry- ing out any troubleshooting on the iOptima. In case of unclear information or for any error message that is not listed in the following tables contact Bien-Air Dental SA.

  • Page 68: Maintenance

    SA directly at the address indicated on the back cover. Note 1 17.2 Cleaning-disinfection • Disinfect the surfaces of the iOptima unit / iOptima dock- in and footpedal by gently rubbing for about 15 seconds with a clean cloth soaked in a suitable product (i.e. Bien-Air Dental Spraynet or isopropyl alcohol) or with an appropriate disinfectant wipe.

  • Page 69: Replace 4Vl Seal

    D. Remove the damaged 4VL seal (2). E. Replace with a new 4VL seal (REF 1302403-010).  Refit hose, switch ON units and water. See chapter “5.1 Install the iOptima app” on page 17 for details. 17.5 iOptima Refer to the iOptima installation manual ...

  • Page 70: General Information And Guarantee

    • 12 months for the hose • 12 months for the power supply • 12months for integrable electronic boards • 24 months for the iOptima/iOptima unit • 36 months for series MX2 LED electric micromotors from the date of invoicing.
  • Page 72 Fax +34 934 23 98 60 20122 Milano, Italy Tel. +81 (3) 5954-7661 Tel. +39 (02) 58 32 12 51 Fax +81 (3) 5954-7660 ba-e@bienair.com Fax +39 (02) 58 32 12 53 ba-asia@bienair.com ba-i@bienair.com REF 2100279-0004/2018.06 iOptima/iOptima © Bien-Air Dental...

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