Sirona SIROLaser Xtend Operating Instructions Manual
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Sirona SIROLaser Xtend Operating Instructions Manual

Sirona SIROLaser Xtend Operating Instructions Manual

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11.2018
New as of:
SIROLaser Xtend
Operating Instructions
English

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Summary of Contents for Sirona SIROLaser Xtend

  • Page 1 11.2018 New as of: SIROLaser Xtend Operating Instructions English...

  • Page 2: Table Of Contents

    Table of contents Sirona Dental Systems GmbH Operating Instructions SIROLaser Xtend Table of contents General information ....................Dear Customer..................... Contact data....................General information on the Operating Instructions ........Intended use ....................Formats and symbols used................Safety information ....................Identification of danger levels ..............
  • Page 3 Sirona Dental Systems GmbH Table of contents Operating Instructions SIROLaser Xtend Initial start-up – procedure for proper assembly........... 4.4.1 Install power supply ............... 4.4.2 Handpiece, single-use tip usage and assembly of optical fiber ..4.4.2.1 Handpiece ..............4.4.2.2 Single-use tip usage .............
  • Page 4 Table of contents Sirona Dental Systems GmbH Operating Instructions SIROLaser Xtend Examples of treatment risk ................Contraindications ..................Cleaning, disinfection and sterilization..............Cleaning....................... Disinfection ....................Sterilization ....................Cleaning the control unit ................Maintenance and service ..................Safety checks....................Maintenance ....................

  • Page 5: General Information

    Please perform maintenance and cleaning based on the corresponding instructions. We wish you much success and pleasure with the SIROLaser Xtend. Your SIROLaser Xtend Team Contact data Customer service center...

  • Page 6: General Information On The Operating Instructions

    If you reach an impasse despite having thoroughly studied the Operating Instructions, please contact your dental depot. Intended use The SIROLaser Xtend is developed as a table top laser device for: ● surgery and coagulating of soft oral tissue ● germ reduction in endodontics ●...

  • Page 7: Safety Information

    Information to make work easier For application information and other useful information. Standards and regulations For the installation and operation of the SIROLaser Xtend, Sirona Dental Systems GmbH requires: ● compliance with IEC 60825-1 and its amendments, ● observance of any supplemental national laws and regulations.

  • Page 8: Operating Personnel

    (wall outlet) the unit may only be used with internal electric power supply (battery). Do not use the SIROLaser Xtend if a visual inspection shows that it has been damaged. 63 18 351 D3576...

  • Page 9: Laser Radiation Hazards

    Observe all labels on the SIROLaser Xtend. Master switch of the practice Note that after switching off the master switch of the practice the SIROLaser Xtend will still remain switched on. It is then energized by the rechargeable battery. Emergency stop In case of an emergency press the "Laser Stop"...

  • Page 10: Laser Protective Goggles

    The optical fiber must not be twisted. There is a risk of breakage. Single-use tips Switch the SIROLaser Xtend off immediately if the optical fiber is broken. Otherwise the single-use tips may become hot. The single-use tips must be checked for sure seating prior to each use.

  • Page 11: Contamination

    Installation 2.11 Location The SIROLaser Xtend is to be protected against the intrusion of liquids. The SIROLaser Xtend must not be used in areas, in which the appearance of liquids is probable. Verify that the line voltage corresponds to the voltage indicated on the rating plate of the power supply or in the technical specifications.

  • Page 12: Modifications

    As manufacturers of dental medical equipment and in the interest of the operational safety of your system, we stress the importance of having maintenance and repair of this product performed only by Sirona Dental Systems GmbH or by agencies expressly authorized by us.

  • Page 13: System Description

    Sirona Dental Systems GmbH 3 System description Operating Instructions SIROLaser Xtend 3.1 System overview System description System overview SIROLaser Xtend (Control unit) LED lights Touch screen Laser Stop key Carry handle Optical fiber Single-use tip Finger switch Handpiece sleeve Handpiece back-sleeve...

  • Page 14: Performance And Equipment Differences

    – Battery: – The SIROLaser Xtend can be upgraded by the customer service. For this purpose the control unit with the handpiece must be returned to Sirona. Please, send the device back only in its original transport packaging to prevent damages.

  • Page 15: Laser Operation Modes

    10 W and a duty cycle of 20%. The average power is 2 W. NOTE The average power may not exceed 4 W in peak-pulse mode with the SIROLaser Xtend. After the upgrade the average power may not 1 000 2 000 3 000 exceed 6 W.

  • Page 16: Symbols And Abbreviations

    3 System description Sirona Dental Systems GmbH 3.4 Symbols and abbreviations Operating Instructions SIROLaser Xtend Symbols and abbreviations 3.4.1 Symbols Type B applied part according to IEC 60601-1 CE mark in accordance with Council Directive 93/42/EEC, stating the manufacturer's Notified Body. Verifies the compliance of the SIROLaser...
  • Page 17 Sirona Dental Systems GmbH 3 System description Operating Instructions SIROLaser Xtend 3.4 Symbols and abbreviations Specification of laser output power and wavelength of IR and aiming beam, see also chapter "Technical data"  [→ 19]. λ = 970 nm ± 15nm λ = 970 nm ± 15nm...

  • Page 18: Abbreviations

    3 System description Sirona Dental Systems GmbH 3.4 Symbols and abbreviations Operating Instructions SIROLaser Xtend 3.4.2 Abbreviations NOHD Nominal ocular Kilovolt hazard distance Continuous Wave Volt-ampere Pulsed Frequency or Effective voltage Chopped Mode Peak-Pulse Threshold voltage cont. continuous Volt per meter...

  • Page 19: Technical Data

    15 V DC 6.66 A max. 100 VA MPU100-106 Insulation class: Class I, type B (according to IEC 60601-1) Adapter: External, 100 - 240 VAC, 50 - 60 Hz Power supply: The SIROLaser Xtend may only be operated with the Sinpro MPU100-106 power supply. 63 18 351 D3576 D3576.201.01.05.02    11.2018...
  • Page 20 The SIROLaser Xtend comes in a cardboard box that ensures proper and easy transport. CAUTION Do not leave the SIROLaser Xtend in a vehicle parked in the sun. The inside temperature of the car could thus heat up to a point where individual components may be damaged.
  • Page 21 3 System description Operating Instructions SIROLaser Xtend 3.5 Technical Data Operating conditions The SIROLaser Xtend may be operated in the following environmental conditions: ● Temperatures from +10° C to +33° C ● Relative humidity from 10% to 95% ● Atmospheric pressure from 800 hPa to 1060 hPa...

  • Page 22: Installation

    4.1 Scope of supply Operating Instructions SIROLaser Xtend Installation Any national or local regulations stipulating that the SIROLaser Xtend may be installed only by trained personnel must be strictly observed. Scope of supply The following components are included in the scope of supply of the...

  • Page 23: Spare Parts

    Sirona Dental Systems GmbH 4 Installation Operating Instructions SIROLaser Xtend 4.2 Spare parts Spare parts Order-No Handpiece sleeve for alternating operation 62 56 767 Handpiece back-sleeve, stainless steel 62 56 817 Set of 320 µm fibers, 5 pcs. 62 56 759 Set of 200 µm fibers, 5 pcs.

  • Page 24: Initial Start-Up - Procedure For Proper Assembly

    NOTE There will be a warning if the rechargeable battery will reach a low level of capacity. The SIROLaser Xtend is fully functional and can be run while charging the battery. ➢ Charge the battery completely. NOTE The rechargeable battery must be fully charged regularly.

  • Page 25: Handpiece, Single-Use Tip Usage And Assembly Of Optical Fiber

    Do not move the fiber in the tip. Do not resterilize the single use tips. To avoid the risk of damaging optical fibers use only Sirona single- use tips. Also make sure that the single-use tips are only bent with the bending tool when the optical fiber is already mounted.

  • Page 26: Optical Fiber Assembly

    The optical fiber is delivered in a special transport and sterilization tube which also assists the mounting of the optical fiber. The optical fibers can be used only with the SIROLaser Xtend in the spectral range of 970 nm ± 15 nm.
  • Page 27 Always wear protective goggles. 7. As soon as the SIROLaser Xtend is ready you can check to make sure that the aiming beam illuminates evenly, i.e. projects a circular light pattern (see adjacent picture).To do this, aim the optical fiber...
  • Page 28 4 Installation Sirona Dental Systems GmbH 4.4 Initial start-up – procedure for proper assembly Operating Instructions SIROLaser Xtend 8. If the aiming beam projects a uniform circular beam pattern, remove the distal seal with the fibercutter, see chapter „Adjusting the optical fiber with the fiber cutter“ ...
  • Page 29 Sirona Dental Systems GmbH 4 Installation Operating Instructions SIROLaser Xtend 4.4 Initial start-up – procedure for proper assembly After treatment Please bend back the single-use tip as straight as possible before moving the fiber within the single-use tip. As soon as you disassemble the optical fiber after treatment make sure to protect the optical fiber socket and the optical fiber with the protective caps provided for this purpose.
  • Page 30 4 Installation Sirona Dental Systems GmbH 4.4 Initial start-up – procedure for proper assembly Operating Instructions SIROLaser Xtend Mounting the optical fiber: 1. Open handpiece by pressing both snap tabs and pull apart the handpiece sleeve from the handpiece body.

  • Page 31: Install Remote Interlock - Optional

    NOTE The installation must be performed by a qualified electrician who is also responsible for the installation and maintenance of the electrical system to which the SIROLaser Xtend is connected. NOTE Additional or different safety precautions required by the applicable national or local regulations for the protection of dentists, assistant personnel, or patients must also be observed.

  • Page 32: Operation

    5 Operation Sirona Dental Systems GmbH 5.1 Start the device for the first time Operating Instructions SIROLaser Xtend Operation Start the device for the first time NOTE Touch screen functionality: When the touch screen is touched by the finger the touch field is highlighted. As soon as the finger leaves the touch screen the action will be started.
  • Page 33 Sirona Dental Systems GmbH 5 Operation Operating Instructions SIROLaser Xtend 5.1 Start the device for the first time C (clear button) User clears letters or digits (going backwards) Cancel User does not want to agree to action. Step back one screen...
  • Page 34 5 Operation Sirona Dental Systems GmbH 5.1 Start the device for the first time Operating Instructions SIROLaser Xtend NOTE Alphabetic and numeric letters, limitation to data input: • Numbers are displayed with English decimals '.' for all languages/ regions. • The power is displayed with one decimal place. Unit is watt (W).

  • Page 35: Switch On Power

    5.2 Switch on power Switch on power After starting the SIROLaser Xtend by switching on the on/off button on the backside of the control unit the yellow LEDs will blinking on. While the SIROLaser Xtend is booting information about the software version and the set language as well as the advice to read the user manual will be displayed.

  • Page 36: Self Test

    Sirona Dental Systems GmbH 5.3 Self Test Operating Instructions SIROLaser Xtend Self Test After booting the SIROLaser Xtend will automatically perform a self test including a status check of the following matters: ● Finger switch ● USB port In addition, you will be informed when the next calibration check or when the next servicing is due.
  • Page 37 If the USB port is marked 'cross' for defective please contact your local dental depot or an authorized Customer Service Department for technical support. The SIROLaser Xtend will remain functional but the download of the history file is not possible. Calibration check...

  • Page 38: Enter Pin Code

    5.4 Enter pin code Operating Instructions SIROLaser Xtend Enter pin code The SIROLaser Xtend may be operated only by authorized personnel and has an electronic key for security purposes. 1. For "User 1" enter the pin code 2 9 7 4, for "User 2" 6 2 5 1.

  • Page 39: Favorites

    5.5 Main home screen 5.5.1 Favorites With the SIROLaser Xtend the submenu 'Favorites' is not available. The touch field 'Favorites' and the buttons are grayed-out. After the upgrade you may use this function. Twelve applications from pre-set applications within the preset submenus Endodontics, Periodontology, Surgery and Miscellaneous or self-defined applications from My Settings can be entered to Favorites.
  • Page 40 LEDs at the upper right and left end of the SIROLaser Xtend control unit light up as well as the laser active bar on the touch screen and the audible alarm sounds. When you release the finger switch to interrupt treatment, the laser is deactivated, but remains ready for operation.
  • Page 41 Sirona Dental Systems GmbH 5 Operation Operating Instructions SIROLaser Xtend 5.5 Main home screen The following is a typical example of a treatment submenu. 1. Selected program in this example Frenectomy 2. Laser power in our example, 3.0 W power. By pushing on the power touch field you will be transferred to another screen where you will be able to adjust the emitted power between 0.5 W and 5 W in 0.1 W increments either by...
  • Page 42 With the SIROLaser Xtend the duty cycle is fixed on 50%. After the upgrade you will be able to push on the duty cycle touch field. Then you will be...
  • Page 43 Sirona Dental Systems GmbH 5 Operation Operating Instructions SIROLaser Xtend 5.5 Main home screen Peak-pulse When pushing the ’PP’ button the peak-pulse mode is set and in the control field appears "PP". Via ’OK’ you will be proceeded back to the treatment submenu in which you can further adjust the time and average power.
  • Page 44 5 Operation Sirona Dental Systems GmbH 5.5 Main home screen Operating Instructions SIROLaser Xtend NOTE Between 1 kHz -10 kHz the duty cycle cannot be below 10% and above 90% due to physical limits. So at 1 kHz -10 kHz any input below 10% will result in an error message. Values below 10% have to be increased to at least 10% and values above 90% have to be decreased to at most 90%.

  • Page 45: My Settings

    Sirona Dental Systems GmbH 5 Operation Operating Instructions SIROLaser Xtend 5.5 Main home screen 11. Laser button By pushing the 'Activate Laser' button the laser will be made ready for operation. 5.5.3 My Settings Up to 24 applications can be generated and saved to My Settings.

  • Page 46: Set-Up

    We recommend performing this check at least once a week. In order to enable exact inspection of the performance and flawless functioning of your SIROLaser Xtend, we recommend performing calibration check at three or rather four different power levels: ● 1 W ●...
  • Page 47 Sirona Dental Systems GmbH 5 Operation Operating Instructions SIROLaser Xtend 5.5 Main home screen 5.5.4.2.1 Calibration check without an external power meter ➢ Select "w/o power meter". Please read the operating instructions and wear protective goggles before proceeding to the calibration check.

  • Page 48: Sound Volume

    (e.g. SMITH instead key user) and to change the pin code 2 9 7 4. The key user is the administrator of the SIROLaser Xtend and has all rights to create and configurate five new users as well as to remove them from the list of users.

  • Page 49: Software Update

    5.5.4.6 Software update If a software update of the SIROLaser Xtend is needed please proceed as follows: 1. Choose in main menu the item "Set-up". 2. Choose there the item "Software update" (these can be found on the second sheet).

  • Page 50: Language

    Ä Now you will have access to the full range of pre-set indications. 5.5.4.11 Battery calibration After the upgrade the SIROLaser Xtend is equipped with a rechargeable battery. For perfect battery performance a battery calibration must be proceeded in any case of having removed and again mounted or completely replaced the battery pack, see chapter „Replacing the rechargeable...

  • Page 51: Error Messages, Warnings And Instructions

    Sirona Dental Systems GmbH 5 Operation Operating Instructions SIROLaser Xtend 5.5 Main home screen 5.5.5 Error messages, warnings and instructions 5.5.5.1 Error messages and warnings There occurred an error There occurred an error Software update or history The battery is malfunction-...
  • Page 52 5 Operation Sirona Dental Systems GmbH 5.5 Main home screen Operating Instructions SIROLaser Xtend There occurred an error Cooling fan is not working. There occurred an error There occurred an error to about the EEPROM com- To avoid damage please...

  • Page 53: Instructions

    Sirona Dental Systems GmbH 5 Operation Operating Instructions SIROLaser Xtend 5.5 Main home screen 5.5.5.2 Instructions Internal calibration check: Internal calibration check: Internal calibration check: External calibration check: 3 Watts level is being 5 Watts level is being 1 Watt level is being 1 Watt level is being...
  • Page 54 5 Operation Sirona Dental Systems GmbH 5.5 Main home screen Operating Instructions SIROLaser Xtend Confirmation if link shall Wrong pin code was en- Before proceeding it is ad- Software update proce- be deleted from 'My Set- tered. Please try again af-...

  • Page 55: Information Messages

    Sirona Dental Systems GmbH 5 Operation Operating Instructions SIROLaser Xtend 5.5 Main home screen To avoid damage of the Please wait until the inter- laser source please wait lock is open. See chapter and let the SIROLaser "Troubleshooting ..."  Xtend cool down. Confir- [→ 65].

  • Page 56: Switching Off The Laser Device

    5 Operation Sirona Dental Systems GmbH 5.6 Switching off the laser device Operating Instructions SIROLaser Xtend Switching off the laser device Laser stop In case of emergency press the laser stop button. Note, that the laser is interrupted and deactivated, but not switched off. If you want to continue, enter the pin code.

  • Page 57: Indications, Contraindications And Medical Precautions

    Treatment with the laser is low-pain and not pain-free. We recommend using anesthetics if necessary. The SIROLaser Xtend may be operated only by trained and qualified personnel. NOTE In terms of their power settings, all presets for surgical indications are defined in a way to enable fast and efficient cutting performance.
  • Page 58 6 Indications, contraindications and medical precautions Sirona Dental Systems GmbH 6.2 List of preset indications Operating Instructions SIROLaser Xtend Application Power Modus Duty Fre- Fiber Help Menu Cycle quenzy [µm] [Hz] Desensitiza- Apply tin fluoride solution as described in tion...

  • Page 59: Further Non-Preset Indications

    Sirona Dental Systems GmbH 6 Indications, contraindications and medical precautions Operating Instructions SIROLaser Xtend 6.3 Further non-preset indications Application Power Modus Duty Fre- Fiber Help Menu Cycle quenzy [µm] [Hz] Frenectomy Stretch the frenulum and stay in contact with the fiber. Use brush stroke at the base to cut through fibrous attachment.

  • Page 60: Examples Of Treatment Risk

    Contraindications All clinical procedures performed with the SIROLaser Xtend must be subjected to the same clinical judgment and care as with traditional techniques. Patient risk must always be considered and fully understood before clinical treatment.

  • Page 61: Cleaning, Disinfection And Sterilization

    7 Cleaning, disinfection and sterilization Operating Instructions SIROLaser Xtend 7.1 Cleaning Cleaning, disinfection and sterilization Following treatment, switch off the SIROLaser Xtend and disconnect the power cable from the power supply. NOTE When following these instructions wear gloves. Control unit, handpiece body and handpiece tube are supposed to be cleaned and wipe-disinfected.

  • Page 62: Disinfection

    Use only disinfectants that comply with the requirements of your national authorities and whose bactericidal, fungicidal and virucidal properties have been tested and properly certified. Sirona recommends the use of MinuteWipes from Alpro. In the USA: ™ Caviwipes Observe the instructions provided by the manufacturers of these disinfectants.

  • Page 63: Sterilization

    4.5 cm (diameter: 9 cm). Be careful not to pinch or tear the optical fiber when inserting or cleaning it. Cleaning the control unit Use a dry, soft cloth to remove dust from the SIROLaser Xtend. More stubborn spots can be removed with a damp cloth. NOTE Please proceed carefully not to scratch and damage the foil on the touch screen.

  • Page 64: Maintenance And Service

    ● NC and SFC housing leakage current acc. to IEC 60601 ● NC and SFC patient leakage current acc. to IEC 60601 ● Laser power measurement with a calibrated measuring instrument in the range between 0.5 W and 5 W with the SIROLaser Xtend or rather up to 7 W after the upgrade. Maintenance The SIROLaser Xtend does not require special maintenance.

  • Page 65: Troubleshooting Of Simple Defects

    ● Modifications of the laser unit or repair work may be performed only by authorized personnel. ● The electrical installations in the rooms where the SIROLaser Xtend is used must fulfill the applicable legal requirements. ● The unit must be used in compliance with the instructions provided in the present manual.

  • Page 66: Technical Support, Repair And Testing

    Customer Service Department for technical support. The SIROLaser Xtend may be sent in for repair or for safety inspection only in its original packaging, including all accessories. Disinfect the SIROLaser Xtend and sterilize the accessories according to the relevant instructions for use before shipping them.

  • Page 67: Replacing The Rechargeable Battery Of The Control Unit

    8.5 Replacing the rechargeable battery of the control unit Replacing the rechargeable battery of the control unit After the upgrade the SIROLaser Xtend is equipped with a rechargeable battery. If the rechargeable battery does not load more than 30% even by charging it overnight, the battery should be replaced.

  • Page 68: Replacement Of Parts Subject To Wear And Tear

    Make sure that the small metal cylinder of the cable is properly placed in the anti-pull protection. Fiber in cable may break if not correctly mounted resulting in high repair costs. Only use the Sirona Dental Systems battery pack, see "Spare parts"  [→ 23]. Replacement of parts subject to wear and tear...

  • Page 69: Electromagnetic Compatibility

    Sirona Dental Systems GmbH 9 Electromagnetic compatibility Operating Instructions SIROLaser Xtend 9.1 Electromagnetic emission Electromagnetic compatibility NOTE The SIROLaser Xtend complies with all requirements for electromagnetic compatibility according to IEC 60601-1-2: 2007 Definitions: Emission (electromagnetic) When electromagnetic energy is emitted by a source. Interference immunity The ability of a device or system to work without errors even if there is electromagnetic interference.

  • Page 70: Interference Immunity

    9 Electromagnetic compatibility Sirona Dental Systems GmbH 9.2 Interference immunity Operating Instructions SIROLaser Xtend Interference immunity The UNIT is intended for operation in the electromagnetic environment specified below. The customer or user of the UNIT should make sure that it is used in such an environment.
  • Page 71 Sirona Dental Systems GmbH 9 Electromagnetic compatibility Operating Instructions SIROLaser Xtend 9.2 Interference immunity Interference IEC 60601-1-2 test level Compliance level Electromagnetic environment – immunity tests guidance Conducted RF d= [1.2] √P interference 150 kHz to 80 MHz IEC 61000-4-6...

  • Page 72: Working Clearances

    9 Electromagnetic compatibility Sirona Dental Systems GmbH 9.3 Working clearances Operating Instructions SIROLaser Xtend Working clearances The UNIT is intended for operation in an electromagnetic environment, where radiated RF interference is checked. The customer or the user of the UNIT can help prevent electromagnetic interference by maintaining...

  • Page 73: Disposal

    Sirona Dental Systems GmbH 10 Disposal Operating Instructions SIROLaser Xtend 9.3 Working clearances Disposal In accordance with Directive 2012/19/EU and national disposal regulations regarding old electrical and electronic devices, please be advised that such items must be disposed of in a special way within the European Union (EU).

  • Page 74: Batteries

    10.1 Please dispose the batteries according to the disposal regulations and legal requirements applicable in your country. Prior to disposal, remove the Lithium battery in the SIROLaser Xtend. Accessories 10.2 Optical fibers, single-use tips, handpiece sleeve incl. plastic body and silicone switch coat, bending tool for single-use tips and fiber cutter may be disposed in the domestic refuse.

  • Page 75: Appendix

    Sirona Dental Systems GmbH 11 Appendix Operating Instructions SIROLaser Xtend 11.1 Appendix A – Certification Appendix Appendix A – Certification 11.1 The unit is manufactured in compliance with the provisions of Council Directive 93/42/EEC concerning medical devices. Appendix B – Label positions 11.2...
  • Page 76 11 Appendix Sirona Dental Systems GmbH 11.2 Appendix B – Label positions Operating Instructions SIROLaser Xtend Bottom side Use only with power supply Sinpro MPU 100-106 CAUTION CLASS 4 VISIBLE AND INVISIBLE LASER RADIATION WHEN OPEN. AVOID EYE OR SKIN EXPOSURE TO DIRECT...

  • Page 77: Appendix C - Safety Circuit (Interlock)

    11.3 Appendix C – Safety circuit (interlock) Appendix C – Safety circuit (interlock) 11.3 Interlock connection supplied with the SIROLaser Xtend (Insulate the jumper between pins 1 and 2; connect both of these pins to relay K1 with a two-core cable).
  • Page 78 We reserve the right to make any alterations which may be required due to technical improvements. © Sirona Dental Systems GmbH Sprache: englisch Printed in Germany D3576.201.01.05.02      11.2018 Ä.-Nr.:  126 130 Sirona Dental Systems GmbH 63 18 351 D3576 Fabrikstr. 31 Order No   ...

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