Sirona Dental Systems GmbH Table of contents Operating Instructions SIROLaser Blue 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................
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Table of contents Sirona Dental Systems GmbH Operating Instructions 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 therapy rods . 4.4.2.1 Handpiece ................. 4.4.2.2 Assembly of sterile single-use optical fiber tips....
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Sirona Dental Systems GmbH Table of contents Operating Instructions SIROLaser Blue Troubleshooting of simple defects..............Technical support, repair and testing ............Replacing the rechargeable battery of the control unit......... Replacing the batteries of the wireless foot control........Replacement of parts subject to wear and tear..........
Please perform maintenance and cleaning based on the corresponding instructions. We wish you much success and pleasure with the SIROLaser Blue. Your SIROLaser Blue Team Contact data Customer service center...
SIROLaser Blue. For indications for use refer to chapter "Indications, contraindications and medical precautions [ → 57]". The use of the SIROLaser Blue is not appropriate in an operating theater. 65 40 863 D3648 D3648.201.01.02.02 10.2015...
1 General information Sirona Dental Systems GmbH 1.5 Formats and symbols used Operating Instructions SIROLaser Blue Formats and symbols used The symbols and character formats used in the present manual have the following meaning: Instructions for action ✔ Prompts you to do something.
Information to make work easier For application information and other useful information. Standards and regulations For the installation and operation of the SIROLaser Blue, Sirona Dental Requirements address, Sirona Systems GmbH requires: ● compliance with IEC 60825-1 and its amendments, Requirements SIROLaser Blue ●...
The SIROLaser Blue may only be used and maintained by thoroughly trained personnel. Physical working principle The 445 nm, 970 nm and 660 nm laser radiation of the SIROLaser Blue SIROLaser Blue is generated via different laser diodes inside the control unit and guided to the treatment region via quartz fibers.
1.5 m. Laser protective goggles All persons present in the room e.g. patient, dentist, assistent must Laser protective goggles SIROLaser Blue always wear the appropriate laser protective goggles delivered along with the SIROLaser Blue. Check before use...
The optical fiber must not be twisted inside the tube of the single-use fiber tip (EasyTip). There is a risk of breakage. Stop the laser activation of the SIROLaser Blue immediately if the EasyTip or MultiTip is broken. Otherwise the tips may become hot.
(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. 65 40 863 D3648...
Product safety, Sirona 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. Furthermore components must always be replaced with original Sirona spare parts upon failure.
Sirona Dental Systems GmbH 3 System description Operating Instructions SIROLaser Blue 3.1 System overview 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...
3 System description Sirona Dental Systems GmbH 3.1 System overview Operating Instructions SIROLaser Blue ON/OFF switch Power supply socket Interlock connector including interlock connector bridge USB port Wireless foot control Wireless foot control – optional Foot switch Registration key Safety and positioning bar 65 40 863 D3648 D3648.201.01.02.02 10.2015...
Sirona Dental Systems GmbH 3 System description Operating Instructions SIROLaser Blue 3.2 Laser operation modes 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). This means a very good power control since the maximum power equals the average power.
3 System description Sirona Dental Systems GmbH 3.3 Symbols and abbreviations Operating Instructions SIROLaser Blue Symbols and abbreviations 3.3.1 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...
Operating Instructions SIROLaser Blue 3.3 Symbols and abbreviations Fragile, Handle with care refer to manuals 3rd edition SIROLaser Blue Please refer to manual first (IEC 60601-1 3rd ed.) Power switch (on the backside of the control unit) Connection socket for DC input from Sinpro MPU101-106 power supply...
3 System description Sirona Dental Systems GmbH 3.3 Symbols and abbreviations Operating Instructions SIROLaser Blue Warns of laser radiation hazards when the fiber connector is unscrewed. FINGER SWITCH "Laser Stop" key: press this button in case of an emergency Operate the unit exclusively with the Sinpro MPU101-106 power supply 3.3.2...
Sirona Dental Systems GmbH 3 System description Operating Instructions SIROLaser Blue 3.4 Technical Data Technical Data General Technical Data SIROLaser Advance Blue 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°...
Sirona Dental Systems GmbH 3.4 Technical Data Operating Instructions SIROLaser Blue Power supply: The SIROLaser Blue may only be operated with the Sinpro MPU101-106 power supply. Input voltage: 100 - 240 VAC Input current: 1.25 - 0.5 A Input frequence: 47 - 63 Hz...
The SIROLaser Blue comes in a cardboard box that ensures proper and easy transport. CAUTION 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.
3 System description Sirona Dental Systems GmbH 3.4 Technical Data Operating Instructions SIROLaser Blue 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).
Operating Instructions SIROLaser Blue 4.1 Scope of supply 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...
NOTICE There will be a warning if the rechargeable battery will reach a low level of capacity. The SIROLaser Blue is fully functional and can be run while charging the battery. ➢ Charge the battery completely. NOTICE The rechargeable battery must be fully charged regularly.
EasyTips are delivered sterile in a special packaging tube, which also SIROLaser Blue 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 ± 5 nm and 970 nm -10/+15 nm. WARNING...
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Sirona Dental Systems GmbH 4 Installation Operating Instructions 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 cleaned in the autoclave (high-pressure sterilizer), see chapter "Cleaning, disinfection and sterilization [ →...
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 at...
Sirona Dental Systems GmbH 4 Installation Operating Instructions SIROLaser Blue 4.4 Initial start-up – procedure for proper assembly Adjusting the position of the endo stopper The single-use fiber tip for endodontic applications (EasyTip Endo) is provided with an already mounted endo stopper, which serves as a stop collar for the length of the root canal.
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 SIROLaser Blue range of 445 nm ± 5 nm, 660 nm ± 5 nm and 970 nm -10/+15 nm.
Sirona Dental Systems GmbH 4 Installation Operating Instructions SIROLaser Blue 4.4 Initial start-up – procedure for proper assembly 4.4.2.3.2 Preparation for clinical application WARNING For safety reason it is necessary to use the 4 mm or the 8 mm light guide (MultiTip) if wavelength of 660 nm is chosen 1.
Technical data of the wireless foot control, see chapter Technical Data, "Wireless foot control". The wireless foot control must be assigned to the SIROLaser Blue via a registration. This prevents malfunctions caused by neighboring wireless controls.
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. NOTICE 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.
5 Operation Sirona Dental Systems GmbH 5.1 Start the device for the first time Operating Instructions SIROLaser Blue Operation Start the device for the first time NOTICE 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.
Sirona Dental Systems GmbH 5 Operation Operating Instructions SIROLaser Blue 5.1 Start the device for the first time All applications User is able to select an application from all applications or to define an own application NOTICE Up to 10 kHz Blue Alphabetic and numeric letters, limitation to data input: •...
Switch on/off power Switch on the laser device After starting the SIROLaser Blue by switching on the on/off button on the backside of the control unit the LEDs will blink. While the SIROLaser Blue is booting information about the software version and the set language as well as the advice to read the user manual will be displayed.
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.
5.5 Main home screen Operating Instructions SIROLaser Blue 5.5.1 Self Test After booting the SIROLaser Blue will automatically perform a self test including a status check of the following matters: ● Wireless foot control vs. finger switch Self Test screen with foot control ●...
NOTICE 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.
5 Operation Sirona Dental Systems GmbH 5.5 Main home screen Operating Instructions SIROLaser Blue 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.
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Sirona Dental Systems GmbH 5 Operation Operating Instructions SIROLaser Blue 5.5 Main home screen Soft Laser Therapy ● Burning mouth-syndrome ● Dentin hypersensitivity ● Wound healing Miscellaneous ● Haemostasis ● Aphthous Ulcers ● Desensitization ● Herpes My applications ● for 24 own applications...
At the same time, two yellow LEDs at the upper right and left end of the SIROLaser Blue 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 or wireless foot control to interrupt treatment, the laser is deactivated, but remains ready for operation.
Sirona Dental Systems GmbH 5 Operation Operating Instructions SIROLaser Blue 5.5 Main home screen 4. Duty cycle in our example, CW (continuous wave mode). The duty cycle is defined as the ratio between the pulse duration (when the laser beam is actually activated) and the total period of time (which is the time from the beginning of a pulse to the beginning of the next pulse).
5.5.3.2.1 Activation device In case you have purchased your SIROLaser Blue with the optional wireless foot control you have the choice to use either the finger switch or the wireless foot control. Select one and confirm by pressing 'OK'.
(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 Blue and has all rights to create and configurate five new users as well as to remove them from the list of users.
The non-usable applications due to the direct selection or the power limit appear shaded and are disabled. 5.5.3.2.5 Software update If a software update of the SIROLaser Blue is needed please proceed as follows: CAUTION Use a USB class 2.0 (or above) memory stick.
Sirona Dental Systems GmbH 5 Operation Operating Instructions SIROLaser Blue 5.5 Main home screen 4. Enter the pin code. The software update was successfully performed. The USB stick can be removed. 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.
● 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.
Sirona Dental Systems GmbH 5 Operation Operating Instructions SIROLaser Blue 5.5 Main home screen The menu asks you to press the finger switch for 3 seconds. 1. Press the finger switch for at least 3 seconds, the laser will stop Up to 7W emission automatically.
5 Operation Sirona Dental Systems GmbH 5.5 Main home screen Operating Instructions SIROLaser Blue If the calibration check is passed successfully, the message "Calibration Test passed" will appear. ➢ Acknowledge with 'OK'. If the laser shows an error message, please contact your local service.
Sirona Dental Systems GmbH 5 Operation Operating Instructions SIROLaser Blue 5.5 Main home screen 5.5.4 Error messages, warnings and instructions Error messages and warnings 5.5.4.1 SIROLaser Blue The screen is displayed in Before battery calibration Pin not correct A message warns the user case of anomaly.
5 Operation Sirona Dental Systems GmbH 5.5 Main home screen Operating Instructions SIROLaser Blue Displayed in case of an Displayed in case when an Displayed in case when the Displayed in case when the error of the finger switch. error of the fan occurs (for currents of the diode differ interlock contact is open.
Sirona Dental Systems GmbH 5 Operation Operating Instructions SIROLaser Blue 5.5 Main home screen Instructions 5.5.4.2 SIROLaser Blue The screen describes how The device asks to remove The device asks to insert The device asks to use the to perform the pairing...
5 Operation Sirona Dental Systems GmbH 5.5 Main home screen Operating Instructions SIROLaser Blue The unit asks to press finger The unit asks to direct the switch for three seconds. laser beam to the power This screen is displayed meter and to press the...
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. List of preset indications...
6 Indications, contraindications and medical precautions Sirona Dental Systems GmbH 6.2 List of preset indications Operating Instructions SIROLaser Blue Application Used Power Mo- Duty Fre- Time Fiber Help Menu wavel Cycle quenz ength [nm] [Hz] Gingival 2,0W 320µm Gently shape the gingival tissue in contact Troughing with the fiber.
Sirona Dental Systems GmbH 6 Indications, contraindications and medical precautions Operating Instructions SIROLaser Blue 6.3 Further non-preset indications Application Used Power Mo- Duty Fre- Time Fiber Help Menu wavel Cycle quenz ength [nm] [Hz] Miscellaneous Haemostasis 2,0W 320µm Stop the blood flow by moving the tip of the laser over the affected tissue surface with opened blood vessels.
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.
7 Cleaning, disinfection and sterilization Operating Instructions SIROLaser Blue 7.1 Cleaning Cleaning, disinfection and sterilization Following treatment, switch off the SIROLaser Blue and disconnect the power cable from the power supply. NOTICE When following these instructions wear gloves. Control unit, handpiece body, handpiece tube and foot control are With foot control supposed to be cleaned and wipe-disinfected.
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.
Store all components so that they are protected against contamination.Sterilize again once the storage period has elapsed. Cleaning the 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.
● Laser power measurement with a calibrated measuring instrument in the range between 0.2 W and 3 W Maintenance The SIROLaser Blue does not require special maintenance. In case of Maintenance table, Sirona malfunctioning, see chapter Technical support, repair and testing.
● 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 the present manual.
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.
Sirona Dental Systems GmbH 8 Maintenance and service Operating Instructions SIROLaser Blue 8.5 Replacing the rechargeable battery of the control unit Replacing the rechargeable battery of the control unit If the rechargeable battery does not load more than 30% even by charging it overnight, the battery should be replaced.
Touch a grounded metal part before opening the housing to prevent damage to the PC board due to electrostatic discharge. CAUTION Prior to changing the batteries, switch the SIROLaser Blue off at the main switch. This prevents accidental triggering. Removing and replacing the batteries 1.
● Batteries in wireless foot control (change after 1 year) For further informations, see chapter "Cleaning, disinfection and sterilization [ → 61]". Only original spare parts, Sirona CAUTION Only use parts from Sirona Dental Systems, see "Spare parts [ → 26]". 65 40 863 D3648 D3648.201.01.02.02 10.2015...
Sirona Dental Systems GmbH 9.1 Electromagnetic emission Operating Instructions SIROLaser Blue Electromagnetic compatibility NOTICE The SIROLaser Blue 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.
Sirona Dental Systems GmbH 9 Electromagnetic compatibility Operating Instructions 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.
Sirona Dental Systems GmbH 9 Electromagnetic compatibility Operating Instructions 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 HF where radiated RF interference is checked. The customer or the user of...
10 Disposal Sirona Dental Systems GmbH Operating Instructions SIROLaser Blue Disposal Based on Directive 2012/19/EU and country-specific disposal directives for waste electrical and electronic equipment, we would like to point out that these must be disposed of in a special way within the European Union (EU).
Prior to disposal, remove the following batteries: With foot control ● Batteries in the wireless foot control ● 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.
11 Appendix Sirona Dental Systems GmbH 11.1 Appendix A – Certification Operating Instructions SIROLaser Blue Appendix 11.1 Appendix A – Certification The unit is manufactured in compliance with the provisions of Council Directive 93/42/EEC concerning medical devices. 11.2 Appendix B -Label positions 11.2.1...
Sirona Dental Systems GmbH 11 Appendix Operating Instructions SIROLaser Blue 11.2 Appendix B -Label positions Bottom side Rear side SIROLaser Advance+ Bottom side SIROLaser Blue Under the battery cover With battery 11.2.2 Wireless foot control – optional sirona. Wireless Footswitch ADVANCE REF 6256841...
Operating Instructions 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)
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