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Rx Only

REF 2100279-0012/2022.0

iOptima
iOptima

INT

ENG

INSTRUCTIONS FOR USE.

Other languages available on www.bienair.com/ifu

Содержание 1700544-001

Страница 1: ...Rx Only REF 2100279 0012 2022 03 iOptima iOptimaINT ENG INSTRUCTIONS FOR USE Other languages available on www bienair com ifu...

Страница 2: ...1600926 001 1x REF 1600677 001 1x REF 1600762 001 1x REF 1501938 001 1x REF 1501988 001 Set iOptima REF 1700544 001 1x REF 1600926 001 1x REF 1600677 001 1x REF 1600762 001 1x REF 1501938 001 Set iOpt...

Страница 3: ...1x REF 1600809 001 1x REF 1601074 001 1x REF 1500666 001 1x REF 1502568 001 1x REF 1300067 001 1x REF 3300404 001 1x REF 3300403 001 Set iOptimaINT REF 1700705 001 1x REF 1502475 001 2x REF 1600677 0...

Страница 4: ...076 001 1x REF 1500666 001 1x REF 1502568 001 1x REF 1300067 001 1x REF 3300404 001 1x REF 3300403 001 1x REF 1303711 010 Set iOptimaINT REF 1700730 001 1x REF 1601074 001 1x REF 1500666 001 1x REF 16...

Страница 5: ...T REF 1700732 001 1x REF 1601076 001 1x REF 1500666 001 1x REF 1600809 001 1x REF 1600606 001 1x REF 1502568 001 1x REF 1300067 001 1x REF 1303711 010 Options 1x REF 1502620 001 1x REF 1502621 001 1x...

Страница 6: ...escription 22 7 Symbols 23 7 1 Description of symbols for iOptimaINT 23 7 2 Description of symbols for iOptimaINT accessories 24 8 Identification Intended use and Notation 25 8 1 Identification 25 8 2...

Страница 7: ...re default and delete user defined systems 58 15 7 Create new Brands and Systems 59 15 8 CA ENDO Reciproc option 60 16 Operation Surgery mode 61 16 1 Enter Surgery mode 61 16 2 Operative screen descri...

Страница 8: ...3...

Страница 9: ...Rx Only iOptima description...

Страница 10: ...by an accredited practitioner Sound alerts WARNING hazard that could result in serious injury or damage to the device if the safety instructions are not correctly followed CAUTION hazard that could re...

Страница 11: ...r Catalogue number Electrical safety Applied part type B Medical device Data Matrix code for product information including UDI Unique Device Identification Authorized EC Representative in the European...

Страница 12: ...ch 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...

Страница 13: ...items screen areas values fields when they are named and screen names Tap Settings to open the Settings screen change parameters and tap Done NOTES 1 The technical specifications illustrations and di...

Страница 14: ...To prevent any risk of motor overheating the cautions below must be observed CAUTION Ensure that the micromotor hose is not bent The iPod touch must never be disconnected from the iOptima dental unit...

Страница 15: ...2 Power Supply C 3 iOptima unit 4 iPod touch not provided in set 5 MX2 micromotor hose output A 6 4 way connector input air and water inlet from your pneumatic unit B 7 Power input connector with loc...

Страница 16: ...m Europe length 2 50 m 1x 1300066 001 3P cable system US length 2 00 m 1x 1300067 001 iOptima bracket 1501988 001 Designation REF number iOptima unit 1x 1600926 001 MX2 Micromotor 1x 1600677 001 MX2 M...

Страница 17: ...on class Class I per IEC 60601 1 apparatus protected against electric shocks Degree of protection IP 40 protection against insertion of objects larger than 1 mm Memory Restorative Storage of 20 user d...

Страница 18: ...user must return the unit to its dealer or establish direct contact with an approved body for treatment and recovery of this type of equipment European Directive 2012 19 EU 4 7 Limitation of liability...

Страница 19: ...fied by the manufacturer Otherwise degradation of the performance of this equipment could result CAUTION The use of accessories transducers and cables other than those specified with the exception of...

Страница 20: ...rt inter ruptions and voltage variations on power sup ply input lines IEC 61000 4 11 0 UT for 0 5 cycle at 0 45 90 135 180 225 270 and 315 0 UT for 1 cycle and 70 UT for 25 30 cycles at 0 0 UT for 0 5...

Страница 21: ...ios AM and FM radio broadcasts and TV broadcasts cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey s...

Страница 22: ...IG 2 B Connect the power cord 2 to the power supply 1 and plug to the mains Note 3 CAUTION The power plug is the device used for disconnection in case of problems it must be easily accessible at all t...

Страница 23: ...t is powered by your mains power supply 100 240 VAC FIG 5 FIG 6 FIG 7 1 2 1 2 1 3 2 4 FIG 5 E Connect the MX2 cable 2 to the MX2 micromotor 1 by guiding the connector and plug with the index pin on th...

Страница 24: ...tion is compatible with iPod touch from 6th generation 6 1 2 Notation In order to simplify the notation in this manual iOptima application is referred to as iOptima app Restorative and Endodontics mod...

Страница 25: ...e displayed The micromotor will not start to run until the footpedal is released and pressed again 6 3 3 iOptima unit switched ON If the iOptima app is running and the iPod touch plugged to the iOptim...

Страница 26: ......

Страница 27: ...Rx Only iOptimaINT description...

Страница 28: ...on recom mendation by an accredited practitioner Sound alerts WARNING hazard that could result in serious injury or damage to the device if the safety instructions are not correctly followed CAUTION h...

Страница 29: ...ber Catalogue number Electrical safety Applied part type B Medical device Data Matrix code for product information including UDI Unique Device Identification Authorized EC Representative in the Europe...

Страница 30: ...nergy of the iPod touch iPad mini The iOptimaINT unit charges the iPod touch iPad mini battery when connected The restorative endodontics and surgery parameters are defined before operation using the...

Страница 31: ...ntal hospital to receive treatment in line with the intended medical condition There is no restriction concerning subject age race or culture The intended user is responsible to select the adequate de...

Страница 32: ...acted or not needs to be removed Non salvageable decayed teeth extraction when a tooth with a decay at an advanced status must be sacrificed because it cannot be restored anymore Guided and not guided...

Страница 33: ...med and screen names Tap Settings to open the Settings screen change parameters and tap Done CAUTION All illustrations and screenshots shown in this manual refer to the iPod touch and may differ from...

Страница 34: ...ways refer to the accessories IFU for dedicated maintenance procedure To prevent any risk of bone overheating the caution below must be observed CAUTION If the irrigation pump is used and regulated by...

Страница 35: ...facturer specifications to set up the console settings Always verify that the configured parameters correspond to your medical application The predefined parameters may be subject to modification with...

Страница 36: ...on pump and communicate with the interface through the Lightning connector A dental micromotor and the related hose MX2 MX i LED A power supply 100 240 VAC Instrument holders which are connected to th...

Страница 37: ...chapter 18 List of errors Troubleshooting on page 71 Voltage 100 240 VAC Frequency 47 63 Hz Nominal power 90 W Max input power 160 W Max input pneumatic pressure 5 bar 72 5 psi Min input pneumatic pr...

Страница 38: ...liable for any non compliant use of the iPod touch iPad mini The conditions for and restrictions on use set by Apple must be respected jailbreak hardware modification etc To ensure optimum operation o...

Страница 39: ...nd other similar devices to ensure that HF cables are not routed above or near the device If in doubt please contact a qualified technician or Bien Air Portable RF communications equipment including p...

Страница 40: ...er supply lines 1 kV for lines no input output Mains power quality should be that of a com mercial or hospital environment Surge IEC 61000 4 5 0 5 kV line to line 1 kV line to line 0 5 kV line to eart...

Страница 41: ...1 1 The essential perfor mance is to maintain the visual luminous intensity of the LED and the motor speed The maximum speed deviation is 5 IEC 61000 4 6 motor rotation slightly perturbed between 950...

Страница 42: ...Pod touch iPad mini 2 The iOptimaINT system must be installed by a service engi neer certified by Bien Air Dental SA 11 Installation 11 1 Install the iOptima app A Open the App Store B Search the iOpt...

Страница 43: ...m 4th generation 12 1 2 Notation In order to simplify the notation in this manual iOptima application is referred to as iOptima app Restorative Endodontics Surgery and Piezo scaling modes are referred...

Страница 44: ...ched ON If the iOptima app is running and the iPod touch iPad mini plugged to the iOptimaINT switch ON The iPod touch iPad mini will charge up even if the app is not running The sleep mode is deactiva...

Страница 45: ...iOptima iOptimaINT operation...

Страница 46: ...ation is operated with the iPod touch iPad mini screen with a few simple gestures FIG 1 Tap to click FIG 2 Slide to scroll and adjust parameters FIG 3 Swipe to restore or remove parameters Note 1 FIG...

Страница 47: ...E Tap the app icon 5 to launch the iOptima application Note 2 FIG 8 CAUTION When used on an iPad mini before starting the app always check that the screen s rotation lock 1 is off by using the screen...

Страница 48: ...Launch iOptima app on page 42 for details The Welcome screen is displayed FIG 11 The Welcome screen differs whether using the iOptima or iOptimaINT system and depends on which type of micromotor is c...

Страница 49: ...nd Bien Air factory information Contact us 7 opens email application with predefined email address iOptima bienair com Troubleshooting 8 opens troubleshooting guide FIG 15 follow the guide in case of...

Страница 50: ...Important if Lock settings is set it is not possible to save any user defined data Note 5 13 8 iOptima app update FIG 21 When the application is launched it will check whether a new version is availab...

Страница 51: ...from the iOptima iOptimaINT dental unit during installation The iOptima application must not be closed during installation The iOptima iOptimaINT power supply must not be disconnected during installa...

Страница 52: ...icromotor torque in Ncm indicative percentage of maximum torque that can be delivered is also displayed or according to settings see chapter 13 7 Settings on page 45 9 Maximum micromotor speed in rpm...

Страница 53: ...value 9 The operative screen always displays the selected footpedal mode 10 In reverse mode CCW the symbol flashes and there is a sound alert alternate medium beeps 11 The operative screen always disp...

Страница 54: ...ght intensity footpedal mode or rotation direction of the selected operation Tap Save 3 to validate the new settings Note 16 E Tap the operation type above 1 or below 2 the selected operation type to...

Страница 55: ...16 Modifications are discarded when leaving the operative screen without saving 17 Predefined RESTO operations can not be deleted But it is pos sible to restore the default values if modified Only use...

Страница 56: ...defined FIG 21 A From the operative screen tap Settings to open the Operations screen FIG 22 B Tap to create a new operation type The Operations screen opens Note 21 FIG 23 C Tap in the Operation name...

Страница 57: ...When an operation is hidden it doesn t show anymore in the operative screen so the user can show only the operation that he wants to use 21 Maximum storage of 20 user defined operations if reached the...

Страница 58: ...Footpedal mode PROGRESSIVE or ON OFF mode 6 Light intensity 7 Handpiece ratio 8 Maximum micromotor torque in Ncm indicative percentage of maximum torque that can be delivered is also displayed or acc...

Страница 59: ...tro valve integrated in the iOptima iOptimaINT unit 2 Save and create buttons are disabled if a lock is set see chapter 13 7 Settings on page 45 3 All parameters can be changed and saved directly in t...

Страница 60: ...C Tap to choose a brand the Systems screen opens FIG 13 D Tap to select a file system Note 14 The app navigates back to the operative screen FIG 14 E Press the dental unit pedal to switch ON the micro...

Страница 61: ...and there is a sound alert alternate medium beeps 13 If using iOptimaINT system each time you pull a motor from a holder the operative mode previously used with that motor is dis played by default on...

Страница 62: ...designation screen select a color for the new file and tap back 6 color designation of file is according to ISO 3630 1 standard D Adjust the micromotor speed and torque values 7 FIG 20 See 15 2 Operat...

Страница 63: ...moved in default and user defined files 20 Predefined ENDO systems can not be deleted But it is possi ble to restore the default values if modified Only user defined systems can be deleted 21 Custom a...

Страница 64: ...chapter 15 5 1 Add new files on page 57 F Tap the icons 6 to set the iOptima unit parameters Handpiece ratio Light intensity Footpedal mode PROGRESSIVE or ON OFF mode Micromotor rotation mode FORWARD...

Страница 65: ...ien Air CA ENDO CA ENDO must be used only with specific tools License not Activated License Activated FIG 34 FIG 35 FIG 36 FIG 37 FIG 38 2 1 3 4 5 6 NOTES 24 New systems and brands can also be created...

Страница 66: ...perative screen displays the selected operation type and settings 1 Settings access to operation types and settings 2 Selected operation type 3 MX i LED micromotor rotation mode FORWARD and REVERSE 4...

Страница 67: ...for each operation The default val ue of the irrigation level is irrigation OFF for Implant operation 8 The operative screen always displays the selected irrigation level value For exemple correspond...

Страница 68: ...to open the Operations screen Note 14 FIG 12 C Tap to select an operation type The App navigates back to the operative screen D Press the dental unit pedal to switch ON the MX i LED micromotor CAUTIO...

Страница 69: ...and torque values displayed toggle back to maximum predefined values 16 All parameters can be directly modified in the operative screen only when the footpedal is released 17 Modifications are discard...

Страница 70: ...ion and display the icons 2 B Tap the icon to drag and drop the operations C Tap Done 1 to validate 16 4 4 Hide show operations FIG 20 A Do a long tap on an operation which is not hidden to activate t...

Страница 71: ...1 2 3 4 NOTES 18 Predefined SURG operations can not be deleted But it is pos sible to restore the default values if modified Only user defined operations can be deleted 19 Custom and user defined ope...

Страница 72: ...le to create and delete User defined operations Note 1 17 2 Operative screen description FIG 2 The operative screen displays the selected operation type and settings 1 Settings access to operation typ...

Страница 73: ...d The piezo scaler will not start to run until the footpedal is released and pressed again If a micromotor else than piezo scaler is unhooked the previous operative mode used with that motor is displa...

Страница 74: ...ters contained in the dental procedures are given for information ONLY Bien Air Dental cannot be held liable for them Note 8 17 4 3 Sort operations FIG 12 A Do a long tap on an operation to activate t...

Страница 75: ...user defined operations if exceeded the icon disappears 17 5 Create new operations user defined FIG 14 A From the operative screen tap Settings to open the Operations screen FIG 15 B Tap to create a...

Страница 76: ...Turn iPod touch iPad mini speaker ON and set sound volume to an appropriate level Non verified iOS version in use iOS version installed on the iPod touch iPad mini has not been verified according to...

Страница 77: ...ystem overheating Please wait until cool Motor drive over temperature failure 1 Wait for system cooling 2 If problem persists contact Bien Air Dental SA GEN ERROR FailCode System electrical failure El...

Страница 78: ...y installed iOS x y z text sec tion is displayed in orange color User must be aware that the configu ration he is using is slightly different from the recommended configura tion Configuration in use i...

Страница 79: ...perative 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 cont...

Страница 80: ...ce was tested by simulating more than 6 000 clinical procedures corresponding to a service period of 4 to 6 years Note 1 19 2 Cleaning Clean the surfaces of the iOptima unit iOptimaINT dock in and foo...

Страница 81: ...VL 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 19 5 iOptimaINT Refer to the iOptimaINT inst...

Страница 82: ...r the power supply 12months for integrable electronic boards 24 months for the iOptima iOptimaINT unit 36 months for series MX2 LED electric micromotors from the date of invoicing In case of justified...

Страница 83: ......

Страница 84: ...ntal Bien Air Dental SA L nggasse 60 Case postale 2500 Bienne 6 Switzerland Tel 41 0 32 344 64 64 Fax 41 0 32 344 64 91 dental bienair com Other adresses available at www bienair com EC REP Bien Air F...

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