Dentsply Sirona SiroLaser Blue Instructions For Use Manual
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Dentsply Sirona SiroLaser Blue Instructions For Use Manual

Dentsply Sirona SiroLaser Blue Instructions For Use Manual

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2023-08
New as of:
SiroLaser Blue
Instructions for use
English

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  • Page 1 2023-08 New as of: SiroLaser Blue Instructions for use English...

  • Page 2: Table Of Contents

    Table of contents Dentsply Sirona Instructions for use SiroLaser Blue Table of contents General information..................Dear Customer ......................Contact data ........................ General information on the Instructions for Use............Structure of the document ................... 1.4.1 Identification of danger levels ............... 1.4.2 Formats and symbols used................
  • Page 3 Dentsply Sirona Table of contents Instructions for use SiroLaser Blue Initial start-up – procedure for proper assembly ............4.4.1 Install power supply ..................4.4.2 Handpiece and assembly of single-use fiber tips and glass rods ....4.4.2.1 Handpiece..................4.4.2.2 Assembly of sterile single-use optical fiber tips ......
  • Page 4 Table of contents Dentsply Sirona Instructions for use SiroLaser Blue Replacing the rechargeable battery of the control unit..........Replacement of parts subject to wear and tear............Electromagnetic compatibility................Electromagnetic emission ................... Interference immunity....................Working clearances..................... Disposal......................10.1 Batteries ........................10.2 Accessories .........................

  • Page 5: General Information

    We are pleased that you have equipped your practice with the SiroLaser Blue The SiroLaser Blue features diode laser technology. This device is characterized by a wide range of applications. A number of output settings are preset in the unit. Manual setting changes can be made and custom presets may also be introduced.

  • Page 6: General Information On The Instructions For Use

    General information on the Instructions for Use Observe the Instructions for Use Please familiarize yourself with the SiroLaser Blue by reading through these Instructions for Use before putting it into operation. It is essential that you comply with the specified warning and safety information.

  • Page 7: Formats And Symbols Used

    SiroLaser Blue. For indications for use refer to chapter "Indications, contraindications and medical precautions  [→ 58]". The use of the SiroLaser Blue is not appropriate in an operating theater. The Laser must be used in combination with the sterile EasyTip. The intended use of sterile laser tips is to guide a laser beam.

  • Page 8: Safety Information

    Unauthorized access In order to prevent false or improper use, the SiroLaser Blue must not be used by unauthorized persons. Therefore the SiroLaser Blue equipment must be protected against unauthorized access when not in use.

  • Page 9: Physical Working Principle

    (wall outlet) the unit may only be used with internal electric power supply (battery). Do not use the SiroLaser Blue if a visual inspection shows that it has been damaged. Laser radiation hazards Never direct the laser or aiming beam toward a person's eye! All persons present in the room e.g.

  • Page 10: Nominal Ocular Hazard Distance

    Label removers and flammable solutions used for cleaning and disinfecting the SiroLaser Blue should be allowed to evaporate before using the device. Observe fire hazards caused by flammable gases. Reducing the risk of burns Unintentional exposure to the laser radiation may lead to burns.

  • Page 11: Easytips And Multitips

    The optical fiber must not be twisted inside the tube of the single-use fiber tip (EasyTip). There is a risk of breakage of the tip. Stop the laser activation of the SiroLaser Blue immediately if the EasyTip or MultiTip is broken. Otherwise the tips may become hot.

  • Page 12: Installation

    Location The SiroLaser Blue is to be protected against the intrusion of liquids. The SiroLaser Blue must not be used in areas in which the presence 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 13: Radiotelephones

    Never disconnect the USB stick during data transfer while you perform a software update. The connection of the SiroLaser Blue to other USB devices could result in previously unidentified risks for your patients, yourself or others. 65 40 863 D3648...

  • Page 14: System Description

    3 System description Dentsply Sirona 3.1 System overview Instructions for use SiroLaser Blue System description System overview SiroLaser Blue (Control unit) LED lights Touch screen Laser Stop key Carry handle Single-use fiber tips (EasyTip) Finger switch with exchangeable keypad Metal handpiece sleeve...

  • Page 15: Laser Operation Modes

    Dentsply Sirona 3 System description Instructions for use SiroLaser Blue 3.2 Laser operation modes ON/OFF switch Power supply socket Interlock connector USB port Laser operation modes Continuous wave mode (CW) CW implies a continuous, uninterrupted laser beam as long as the laser is activated (and determined by a time set).

  • Page 16: Symbols And Abbreviations

    3 System description Dentsply Sirona 3.3 Symbols and abbreviations Instructions for use SiroLaser Blue Symbols and abbreviations 3.3.1 Symbols Type B applied part according to IEC 60601-1 This product is compliant with EU Medical Device Regulation 2017/745 including all amendments.  This label stands for device compliance with FDA laser product...
  • Page 17 Dentsply Sirona 3 System description Instructions for use SiroLaser Blue 3.3 Symbols and abbreviations Do not use when packaging is damaged Temperature limitations, transport and storage Protect against moisture, keep dry Fragile, Handle with care Please refer to manual first (IEC 60601-1 3rd ed.)
  • Page 18 3 System description Dentsply Sirona 3.3 Symbols and abbreviations Instructions for use SiroLaser Blue Warns of Class 4 laser radiation hazards when using the unit. CAUTION VISIBLE AND INVISIBLE LASER RADIATION. AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION CLASS 4 LASER PRODUCT Warns of potential laser radiation hazards when opening the laser unit.

  • Page 19: Abbreviations

    Dentsply Sirona 3 System description Instructions for use SiroLaser Blue 3.3 Symbols and abbreviations 3.3.2 Abbreviations NOHD Nominal ocular haz- Volt-ampere ard distance Continuous Wave Effective voltage Pulsed Frequency or Threshold voltage Chopped Mode cont. continuous Volt per meter approximately Milliampere prox.

  • Page 20: Technical Data

    3 System description Dentsply Sirona 3.4 Technical Data Instructions for use SiroLaser Blue Technical Data General Beam guide: Flexible quartz glass fiber Display: Full color, graphical LCD touch screen Cooling: Internal air cooling controlled by output Temperature switch: Software temperature switch at 48° C Door contact connec- Potential-free contact 5 VDC/20 mA (TTL)
  • Page 21 Type of protection SiroLaser handpiece applied part type B against electric shock: Power supply: The SiroLaser Blue may only be operated with the Sinpro MPU101-106 power sup- ply. Input voltage: 100 - 240 VAC Input current: 1.25 - 0.5 A...
  • Page 22 NOTICE Overheating Do not leave the SiroLaser Blue 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. To ensure appropriate protective storage, the device must always be kept in the box supplied by Dentsply Sirona.
  • Page 23 Dentsply Sirona 3 System description Instructions for use SiroLaser Blue 3.4 Technical Data Sterile delivered single-use fiber tips Labeling Each tip is sterilized with gas (ethylene oxide). A label on the outer packing of each set of 25 single-use fiber tips indicates the sterilization procedure (see 3.3.1 symbols).

  • Page 24: Installation

    4.1 Scope of supply Instructions for use SiroLaser Blue Installation Any national or local regulations stipulating that the SiroLaser Blue 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 25: Spare Parts

    Dentsply Sirona 4 Installation Instructions for use SiroLaser Blue 4.2 Spare parts SiroLaser Blue Order-No for the following countries: Order-No Germany, Austria 65 40 491 Switzerland 65 40 632 Netherlands, Belgium 65 40 509 France 65 40 640 England 65 40 624...

  • Page 26: Labels

    There will be a warning if the rechargeable battery reaches a low level of capacity. This is indicated by the red LED bar on the top of the control unit. The SiroLaser Blue is fully functional and can be run while charging the battery. ➢ Charge the battery completely.

  • Page 27: Handpiece And Assembly Of Single-Use Fiber Tips And Glass Rods

    The handpiece can simply be clipped out of the handpiece holder. The cable is unwound in a clockwise direction. Accordingly, it is essential to wind the cable back up counterclockwise in the gap on the base of the SiroLaser Blue and clip the handpiece into the handpiece holder. CAUTION Incorrect winding Incorrect winding of the cable can cause the fiber optics inside the cable to break.

  • Page 28: Assembly Of Sterile Single-Use Optical Fiber Tips

    EasyTips are delivered sterile in a special packaging tube, which also assists the mounting of the fiber tips.The optical single-use fiber tips can be used only with the SiroLaser Blue in the spectral range of 445 nm -10/+15 nm and 970 nm -10/+15 nm.
  • Page 29 Dentsply Sirona 4 Installation Instructions for use SiroLaser Blue 4.4 Initial start-up – procedure for proper assembly 4.4.2.2.2 Preparation for clinical application 1. The EasyTips are delivered sterile. The metal handpiece sleeve can be sterilized in the autoclave (high-pressure sterilizer), see chapter "Cleaning, disinfection and sterilization ...
  • Page 30 Always wear protective goggles. 8. As soon as the SiroLaser Blue 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 EasyTip vertically...
  • Page 31 Make sure that no dust or dirt enters the optical system. Otherwise the unit may be permanently damaged. Wind the cable up counterclockwise in the gap on the base of the SiroLaser Blue and clip the handpiece into the handpiece holder. 65 40 863 D3648 D3648.201.01.07.02    2023-08...

  • Page 32: Assembly Of Therapy Light Guide

    = week year e.g. 0215 for calendar week 2, 2015). Please replace the light guide accordingly. The optical output can be reduced. The MultiTips can be used only with the SiroLaser Blue in the spectral range of 445 nm -10/+15 nm, 660 nm ± 5 nm and 970 nm -10/+15 nm.
  • Page 33 Make sure that no dust or dirt enters the optical system. Otherwise the unit may be permanently damaged. Wind the cable up counterclockwise in the gap on the base of the SiroLaser Blue and clip the handpiece into the handpiece holder. 65 40 863 D3648 D3648.201.01.07.02    2023-08...

  • Page 34: Install Remote Interlock - Optional

    NOTICE 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 Blue is connected. IMPORTANT Additional or different safety precautions 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 35: Operation

    Dentsply Sirona 5 Operation Instructions for use SiroLaser Blue 5.1 Start the device for the first time Operation Start the device for the first time IMPORTANT Touch screen functionality When the touch screen is touched by the finger, the touch field is highlighted.
  • Page 36 5 Operation Dentsply Sirona 5.1 Start the device for the first time Instructions for use SiroLaser Blue Settings User is able to do all the necessary settings, e.g. language settings All applications User is able to select an application from all applications or to define a...

  • Page 37: Switch On/Off Power

    Switch on/off power Switch on the laser device The LEDs will blink after starting the SiroLaser Blue by switching on the on/off button on the backside of the control unit. While the SiroLaser Blue is booting, information about the software version and the set language as well as the note to read the user manual will be displayed.

  • Page 38: Enter Pin Code

    Miscellaneous, and My Applications. All submenus are structured the same way. ● Settings Within this submenu you will be able to configure the SiroLaser Blue to your needs as well as you will find all necessary settings and service programs.

  • Page 39: Self Test

    If the USB port error is displayed on the home screen as defective, please contact your local dental dealer or an authorized Customer Service Department for technical support. ➢ The SiroLaser Blue will remain functional but the download of the history file / software updates are not possible. 65 40 863 D3648...
  • Page 40 IMPORTANT Regular safety test Legal regulations require a regular safety test of the performance of a laser device. The SiroLaser Blue needs to be tested once every two years. ➢ Please contact your local dental dealer or an authorized Customer Service Department for technical support.

  • Page 41: Favorites

    Dentsply Sirona 5 Operation Instructions for use SiroLaser Blue 5.5 Main home screen 5.5.2 Favorites Six applications from pre-set applications within the preset submenus Surgery, Periodontology, Endodontics, Miscellaneous and Soft Laser Therapy or self-defined applications from My Applications can be defined as favorite applications directly accessible from the home screen.

  • Page 42: Submenu: All Applications

    5 Operation Dentsply Sirona 5.5 Main home screen Instructions for use SiroLaser Blue 5.5.3 Submenu: All applications The submenus of the surgery, periodontology, endodontics, soft laser therapy and miscellaneous areas as well as the area of own applications are arranged in the same way. After opening the submenus, you can select among different indications with preset treatment parameters.
  • Page 43 When you actuate the finger switch, the laser output is activated. At the same time, two yellow LEDs at the upper right and left end of the SiroLaser Blue control unit light up, as does the ’laser active’ bar on the touch screen and the audible alarm sounds. When you release the finger switch to interrupt treatment, the laser output is deactivated, but the laser remains ready for operation.
  • Page 44 5 Operation Dentsply Sirona 5.5 Main home screen Instructions for use SiroLaser Blue 1. Selected program In this example: Frenectomy 2. Laser power In this example, the power output setting is 2.0 W. 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 0.2 W and 3.0 W in...
  • Page 45 Dentsply Sirona 5 Operation Instructions for use SiroLaser Blue 5.5 Main home screen 5. Frequency In our example, the frequency is set to CW (continuous wave) mode. This is the modulation frequency of the laser unit. By pushing ‘frequency‘ touch screen you will be transferred to another screen where you will be able to enter the laser operation mode.

  • Page 46: My Applications

    5 Operation Dentsply Sirona 5.5 Main home screen Instructions for use SiroLaser Blue 5.5.3.1 My Applications Up to 24 applications can be generated and saved to My Applications. IMPORTANT Remove an application from list If My Applications are full and the addition of another application is attempted, a warning screen will signal that remove an application must be removed or the chosen application will not be saved.
  • Page 47 (e.g. SMITH instead key user) and to change the default PIN code 2 9 7 4. The key user is the administrator of the SiroLaser Blue and has all rights to create and configure up to five adittional users as well as to remove users.
  • Page 48 5 Operation Dentsply Sirona 5.5 Main home screen Instructions for use SiroLaser Blue The key user decides if this user will be allowed to change preset applications. IMPORTANT No My Applications screen If 'no' is entered, there will be no My Applications screen for this user.
  • Page 49 Detect USB stick The system requires approx. 5 seconds to detect the USB stick. 5.5.3.2.5 Software update If a software update of the SiroLaser Blue is needed, please proceed as follows: NOTICE USB stick requirements Use a USB class 2.0 (or above) memory stick.
  • Page 50 5 Operation Dentsply Sirona 5.5 Main home screen Instructions for use SiroLaser Blue 5.5.3.2.6 History file After having finished a treatment, all parameters will be saved and documented in the history file - i.e. user name, application, date & time, as well as power, laser activation time, energy, and average power of the treatment.
  • Page 51 ● 1 W (445 nm) ● 1 W (970 nm) ● 100 mW (660 nm) The SiroLaser Blue performs a self-calibration. During this procedure, the system checks that the laser emission parameters are correct. We recommend that you check these values using a suitable external measuring instrument at least every twelve months. If the measurement readings indicate the following values, the calibration is correct: ●...
  • Page 52 5 Operation Dentsply Sirona 5.5 Main home screen Instructions for use SiroLaser Blue 5.5.3.2.8.1 Calibration check without an external power meter ➢ Select "w/o power meter". Please read the Instructions for Use and wear protective goggles before proceeding to the calibration check.
  • Page 53 Dentsply Sirona 5 Operation Instructions for use SiroLaser Blue 5.5 Main home screen 1. For each value, the device asks to perform a measurement and indicate if the measured value is within the tolerance (value -20% / value +20%). 2. Press the finger switch for at least 3 seconds while directing the laser to the head of the power meter.

  • Page 54: Error Messages, Warnings And Instructions

    5 Operation Dentsply Sirona 5.5 Main home screen Instructions for use SiroLaser Blue 5.5.4 Error messages, warnings and instructions 5.5.4.1 Error messages and warnings Before battery calibration, The screen is displayed in Pin not correct Warns the user that USB this screen is displayed.
  • Page 55 Dentsply Sirona 5 Operation Instructions for use SiroLaser Blue 5.5 Main home screen Displayed when the diode Displayed when an error Displayed when there is a Displayed when the inter- current differs by more of the fan occurs (for ex- finger switch error.

  • Page 56: Instructions

    5 Operation Dentsply Sirona 5.5 Main home screen Instructions for use SiroLaser Blue 5.5.4.2 Instructions To perform any calibration Prior to starting battery The device asks to insert The device asks to use the check it is advised to read...

  • Page 57: Information Messages

    Dentsply Sirona 5 Operation Instructions for use SiroLaser Blue 5.5 Main home screen The unit asks that the -fin- ger switch is pressed for three seconds. This screen is displayed during laser calibration for the calibration process (without power meter) Confirmation via ‘OK’...

  • Page 58: Indications, Contraindications And Medical Precautions

    Blue offers the following advantages: less invasive, minimum cell destruction, less bleeding, better coagulation, and negligible post- operative edema. Treatment with the laser is low-pain and not pain-free. We recommend using anesthetics if necessary. The SiroLaser Blue may be operated only by trained and qualified personnel. IMPORTANT...
  • Page 59 Dentsply Sirona 6 Indications, contraindications and medical precautions Instructions for use SiroLaser Blue 6.2 List of preset indications Application Used Power Mo- Duty Fre- Time Fiber Help Menu wave- Cycle quenz length [nm] [Hz] Gingivectomy 2,0W 320µm Gently remove the gingival tissue in contact with the fiber.
  • Page 60 6 Indications, contraindications and medical precautions Dentsply Sirona 6.2 List of preset indications Instructions for use SiroLaser Blue Application Used Power Mo- Duty Fre- Time Fiber Help Menu wave- Cycle quenz length [nm] [Hz] Pulpotomy 2,0W 200µm After conventional pulp removal,...

  • Page 61: Further Non-Preset Indications

    Dentsply Sirona 6 Indications, contraindications and medical precautions Instructions for use SiroLaser Blue 6.3 Further non-preset indications Application Used Power Mo- Duty Fre- Time Fiber Help Menu wave- Cycle quenz length [nm] [Hz] Desensitiza- 1,0W 320µm Apply tin fluoride solution as de-...

  • Page 62: Examples Of Treatment Risk

    Contraindications All clinical procedures performed with the SiroLaser Blue 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 63: Cleaning, Disinfection And Sterilization

    Manual cleaning must always be combined with disinfection. All tissue residues must be removed from the optical fiber before it is detached from the handpiece. Following treatment, switch off the SiroLaser Blue and disconnect the power cable from the power supply. IMPORTANT Gloves Wear gloves during these procedures.

  • Page 64: Cleaning

    ➢ Before cleaning the laser protective goggles, please read and observe the instructions for use provided by the manufacturer. Control unit Use a dry, soft cloth to remove dust from the SiroLaser Blue. More stubborn spots can be removed with a damp cloth. NOTICE Please proceed carefully not to scratch and damage the foil on the touch screen.

  • Page 65: Disinfection

    MinuteWipes, Caviwipes. NOTICE Only wiping Spray disinfection may allow liquids to penetrate into the SiroLaser Blue! The SiroLaser Blue may be disinfected only by wiping it. Do not spray disinfect the SiroLaser Blue laser unit. 65 40 863 D3648 D3648.201.01.07.02    2023-08...

  • Page 66: Sterilization

    EN 13060 class B or validated steam sterilizer (EN 13060 class S) which are employing three, separate initial vacuum air-purges being suitable for the sterilization of dental handpieces. "For example Dentsply Sirona DAC PROFESSIONAL or DAC PREMIUM." IMPORTANT...

  • Page 67: Maintenance And Service

    Dentsply Sirona 8 Maintenance and service Instructions for use SiroLaser Blue 8.1 Safety checks Maintenance and service Safety checks The following safety checks must be performed every 24 months by a qualified service engineer: ● Visual inspection of the unit and its accessories for mechanical damage that might impair operation ●...

  • Page 68: Cleaning The Handpiece Optics

    8 Maintenance and service Dentsply Sirona 8.2 Cleaning the handpiece optics Instructions for use SiroLaser Blue Cleaning the handpiece optics NOTICE Cleaning Cycle From time to time the cleaning of the handpiece optics can be required because of soiled optics, for example due to a missing optic protection cap.

  • Page 69: Maintenance

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

  • Page 70: Troubleshooting Of Simple Defects

    ● Be sure that all operational steps have been carried out correctly. ● Check the functioning of the finger switch by pressing several times. If the touch screen of the SiroLaser Blue remains dark after switching it ● Check the connection of the power cable and/or check the rechargeable battery.

  • Page 71: Technical Support, Repair And Testing

    Please contact your local dental dealer or an authorized Customer Service Department for technical support. The SiroLaser Blue may be sent in for repair or for safety inspection only in its original packaging, including all accessories. Disinfect the SiroLaser Blue and sterilize the accessories according to the relevant instructions for use before shipping them.

  • Page 72: Replacing The Rechargeable Battery Of The Control Unit

    Make sure that the small metal cylinder of the cable is properly placed in the anti-pull clamp. Fiber in the cable may break if not correctly mounted, resulting in high repair costs. Only use the Dentsply Sirona battery pack, see "Spare parts  [→ 25]". 65 40 863 D3648 D3648.201.01.07.02    2023-08...

  • Page 73: Replacement Of Parts Subject To Wear And Tear

    ● Rechargeable battery (change after 1000 charging cycles or every two years) For further information, see chapter "Cleaning, disinfection and sterilization  [→ 63]". NOTICE Spare parts Only use parts from Dentsply Sirona, see "Spare parts  [→ 25]". 65 40 863 D3648 D3648.201.01.07.02    2023-08...

  • Page 74: Electromagnetic Compatibility

    9.1 Electromagnetic emission Instructions for use SiroLaser Blue Electromagnetic compatibility IMPORTANT Requirements for electromagnetic compatibility The SiroLaser Blue complies with all requirements for electromagnetic compatibility according to IEC 60601-1-2. 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 75: Interference Immunity

    Dentsply Sirona 9 Electromagnetic compatibility Instructions for use SiroLaser Blue 9.2 Interference immunity 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 76 9 Electromagnetic compatibility Dentsply Sirona 9.2 Interference immunity Instructions for use SiroLaser Blue 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 Radiated RF 3 V/m d= [1.2] √P...

  • Page 77: Working Clearances

    Dentsply Sirona 9 Electromagnetic compatibility Instructions for use SiroLaser Blue 9.3 Working clearances Working clearances Recommended working clearances The UNIT is intended for operation in an electromagnetic environment, between portable and mobile RF where radiated RF interference is checked. The customer or the user of...

  • Page 78: Disposal

    10 Disposal Dentsply Sirona Instructions for use SiroLaser Blue 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 79: Batteries

    Batteries 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 Blue. 10.2 Accessories MultiTips, handpiece sleeve incl. keypad for finger switch, bending tool for EasyTips and fiber cutter may be disposed in the domestic refuse.

  • Page 80: Appendix

    11 Appendix Dentsply Sirona 11.1 Appendix A – Certification Instructions for use SiroLaser Blue Appendix The labels are shown only for illustration. For further information see chapter "Symbols and abbreviations  [→ 16]". 11.1 Appendix A – Certification The unit is manufactured in compliance with the provisions of Medical Device Regulation 2017/745 concerning medical devices.
  • Page 81 Dentsply Sirona 11 Appendix Instructions for use SiroLaser Blue 11.2 Appendix B - Label positions Bottom side Under the battery cover 65 40 863 D3648 D3648.201.01.07.02    2023-08...

  • Page 82: Appendix C - Safety Circuit (Interlock)

    Instructions for use SiroLaser Blue 11.3 Appendix C – Safety circuit (interlock) Interlock connection supplied with the SiroLaser Blue (Insulate the jumper between pins 1 and 2; connect both of these pins to relay K1 with a two-core cable). Low-level relay (AC)
  • Page 84 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 D3648.201.01.07.02      2023-08 Ä.-Nr.:  131 140 SIRONA Dental Systems GmbH 65 40 863 D3648 Fabrikstraße 31 Order No   ...

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