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claros
user manual
claros
ENGLISH V4.8 / 2022-06
claros-Bedienungsanleitung_ENG_V4.8 June_2022
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Summary of Contents for elexxion claros

  • Page 1 ENGLISH V4.8 / 2022-06 claros-Bedienungsanleitung_ENG_V4.8 June_2022 1 / 39...
  • Page 2 Grafik: Release / Date: V4.8 /2022-06 2797 Forwarding and reproduction of this document and communication of its contents are not permitted, unless expressly a2uthorizedby the manufacturer. All rights and utility model protection reserved © elexxion claros-Bedienungsanleitung_ENG_V4.8 June_2022 2 / 39...
  • Page 3: Table Of Contents

    7.6. Settings in the System menu 7.6.1. Settings 7.6.2. Touchscreen calibration 7.6.3. System status 8. Handling of handpieces and fibers 8.1. ergoflex plus 8.1.1. Introducing the application fibers 8.1.2. Adjusting the fiber length 8.2. ergo T claros-Bedienungsanleitung_ENG_V4.8 June_2022 3 / 39...
  • Page 4 9. Accessories 9.1. Installation and handling of elexxion claros comfort 10. Cleaning and sterilisation 10.1.Cleaning 10.2.Packaging 10.3.Sterilisation 11. Maintenance 12. Service life 13. Disposal 13.1.Packaging 13.2. Device 14. Technical data 14.1.Description of the beam guiding system: 14.2.Laser aperture: 14.3.Technical data of claros: 14.4.Precision of displayed operating data:...
  • Page 5: General Information

    1. General information Display / touch-panel Emergency switch Mains connection-/mains switch / fuses Ventilation openings Foot switch Handpiece Interlock connection Key card - insert Type label Fiber connection (laser exit) Open side fiber cover by pivoting forward claros-Bedienungsanleitung_ENG_V4.8 June_2022 5 / 39...
  • Page 6: Labelling And Warning Notices

    Laser warning sign, laser radiation Avoid eye exposure to direct or scattered radiation Avoid skin exposure to direct or scattered radiation Laser transmission part Mains connection / fuses: Film label, on the left-hand side of the housing: claros-Bedienungsanleitung_ENG_V4.8 June_2022 6 / 39...
  • Page 7 At the laser aperture: Laser output opening for visible and invisible laser radiation Laser type: Film label, yellow / black, right-hand side of the housing under the side flap: claros-Bedienungsanleitung_ENG_V4.8 June_2022 7 / 39...
  • Page 8: Labels On Accessories

    2.2.Labels on accessories Foot-switch: Foil label on bottom of device application-fibers: Foil label on bottom of storage-box: claros-Bedienungsanleitung_ENG_V4.8 June_2022 8 / 39...
  • Page 9 Handpieces: Foil label on bottom of the storage box Laser safety glasses: Labeling / Instructions from manufacturer claros-Bedienungsanleitung_ENG_V4.8 June_2022 9 / 39...
  • Page 10: Warning Notices

    To prevent eye damage, the prescribed safety glasses must be worn by all people in the room. CE- designated safety glasses as per EN 207:1998 with scale number 5 or higher are to be used, as supplied by elexxion AG under the name “elexxion claros protect“.
  • Page 11: Warning Notices - System Hazard

    Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the claros, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • Page 12: Electromagnetic Compatibility (Emc)

    4.1.General information claros is a class A device in accordance with CISPR 11 and is intended for use by medical specialists only. claros is intended for use in settings other than residential settings. This equipment with no ESSENTIAL PERFORMANCE is intended used in Professional healthcare facility environment, such as a hospital, clinic or doctor's surgery.
  • Page 13: Guidelines And Manufacturer Declarations

    Test Immunity test levels frequ Band Professional healthcare facility environment ency (MHz) (MHz) 380-390 Pulse modulation 18Hz, 27V/m 430-470 FM, ±5kHz deviation, 1kHz sine, 28V/m 704-787 Pulse modulation 217Hz, 9V/m 800-960 Pulse modulation 18Hz, 28V/m claros-Bedienungsanleitung_ENG_V4.8 June_2022 13 / 39...
  • Page 14 Professional healthcare facility environment Electrical fast IEC 61000-4- ±1 kV transient 100kHz repetition frequency s/burst Conducted disturban 3V, 0.15MHz-80MHz IEC 61000-4- 6V in ISM bands between 0.15MHz and 80MHz induced 80%AM at 1kHz by RF fields claros-Bedienungsanleitung_ENG_V4.8 June_2022 14 / 39...
  • Page 15 Max calbe length Cable Number Cable classification Shielded/ unshielded AC power 2.5m Shielded 1 set AC- Power line SIGNAL Foot switch Unshielded 1 set INPUT/OUTPUT line PORT Hand piece -Coupled PATIENT 1.7m Unshielded 1 set line Cable claros-Bedienungsanleitung_ENG_V4.8 June_2022 15 / 39...
  • Page 16: Intended Use

    5. Intended use Elexxion Claros is a class 4 diode laser system for use in dental medicine and that can be used in the following fields: Surgery and Haemostasis • Applications in the field of surgical incision to cut soft tissue in the mouth and stop bleeding Endodontology •...
  • Page 17: Protection And Safety Regulations

    Low risk 1 claros-Bedienungsanleitung_ENG_V4.8 June_2022 17 / 39...
  • Page 18: Contraindications

    Users (laser protection officers) who intended ongoing education events, as offered by elexxion AG, are instructed on the dangers of laser radiation and trained in how to handle the laser device (see also “Intended Use“).
  • Page 19: Operation

    Insert the interlock plug into the “Interlock“ connection socket behind the side housing cover and secure it by turning the union nut clockwise. Insert the “All Applications“- or “Therapy“-key-card into the insertion slot behind the side housing cover. claros-Bedienungsanleitung_ENG_V4.8 June_2022 19 / 39...
  • Page 20 If this is the case, the system may no longer be used. The claros system is delivered with two different key-cards: “All Programs“: key-card for highly qualified, trained; medical or dental personnel. All applications and settings in the system menu.
  • Page 21: Selection Of Application Programs

    In the middle of the main windows, a flashing warning symbol appears during laser emission. An alert signal also sounds. The parameters of the selected application program are shown in the lower part of the main window. The output of the claros-Bedienungsanleitung_ENG_V4.8 June_2022 21 / 39...
  • Page 22: Modifying The Application Programs

    To modify the parameters, mark the desired parameter using the arrow keys. Actuating the “Edit“ key activates Edit mode. The selected parameter can be varied using the arrow keys. Actuating the “Save“key saves the modified parameter. If claros-Bedienungsanleitung_ENG_V4.8 June_2022 22 / 39...
  • Page 23: Settings In The System Menu

    “Surgery“ key and then the “System“ key. If not all 4 points were touched, wait 10 seconds. The old settings are then automatically retained. 7.6.3. System status claros-Bedienungsanleitung_ENG_V4.8 June_2022 23 / 39...
  • Page 24: Handling Of Handpieces And Fibers

    8.1.ergoflex plus 8.1.1. Introducing the application fibers The claros system is fitted with an innovative application system, which keeps subsequent costs as low as possible and ensures a high level of hygiene capability at the same time. Depending on the diameter of the application fibers, various soft metal tips must be attached before introducing the application fibers: Pink for 200 µm/300 µm fibers...
  • Page 25: Adjusting The Fiber Length

    Straighten the tube after use. Then separate the handpiece from the fiber cable and pull the fiber out of the handpiece. Do not adjust the fiber length when the tube is bent! claros-Bedienungsanleitung_ENG_V4.8 June_2022 25 / 39...
  • Page 26: Ergo T

    Remove the safety cap from transmission fiber, pull the interlock ring to the rear and press the handpiece into the handpiece holder until it can be heard to engage. To undo the handpiece, the interlock ring must be pulled back. claros-Bedienungsanleitung_ENG_V4.8 June_2022 26 / 39...
  • Page 27: Accessories

    9. Accessories claros is a diode laser system for dental use. It comprises a base unit in which laser radiation is generated, and a set of accessory parts: Article Article 14584 claros: base unit including transmission fiber 11317- ergoflex plus: handpiece for use with application fibers includes...
  • Page 28: Cleaning And Sterilisation

    Note: Using a syringe or water jet can make it easier to rinse out areas that are difficult to access, as well as small fitting • surfaces. Remove instruments from the cleaning solution and rinse them with clean water for at least a minute. Thoroughly rinse lumina, • blind holes and other difficult-to-reach areas. claros-Bedienungsanleitung_ENG_V4.8 June_2022 28 / 39...
  • Page 29: Packaging

    3x200 – Vacuum 1500mbar Hold time 5 min 134°C Saturated steam 134°C Drying 5 min <100mbar ! PLEASE NOTE We recommend that after repeated sterilisations a suitable optical inspection is carried out (for visual damage etc.). claros-Bedienungsanleitung_ENG_V4.8 June_2022 29 / 39...
  • Page 30: Maintenance

    ! PLEASE NOTE If the device does not undergo this inspection on schedule, elexxion AG cannot guarantee unrestricted operating safety. Any warranty and liability claims on the part of the manufacturer shall also expire. All maintenance work must be performed by providers that have been authorized by elexxion AG to maintain the device type in question.
  • Page 31: Service Life

    12. Service life The claros system and accessories have a service life of at least 10 years when used in accordance with their intended use, when subject to proper care and maintenance and when requirements with regard to technical safety inspections are observed.
  • Page 32: Technical Data Of Claros

    14.3. Technical data of claros: Mains: 220-240 V, 50/60 Hz Hz Power consumption: 1,5 A Fuses: 1,6 A T as per IEC 60127-2/III (2 x) Operating type: short-term operation: laser emission 2 min ON / 1 min OFF Protection class: I application part type B, IP X0...
  • Page 33: Error Messages

    Fiber not connected to device Screw fiber finger-tight to stop “Shutter does not open“ Malfunction of the beam attenuator If this recurs, contact elexxion service “Shutter does not close“ Malfunction of the beam attenuator If this recurs, contact elexxion service “Check interlock“...
  • Page 34 “Maximum permitted output Further output increase not possible reached“ “Minimum permitted output Further output reduction not possible reached“ “Selection blocked“ Wrong key-card Insert “All Programs“ key-card claros-Bedienungsanleitung_ENG_V4.8 June_2022 34 / 39...
  • Page 35: Repair Service

    16. Repair service If the device or a accessory part needs to be sent to elexxion AG to repair, please visit our web site at easc.elexxion.com (RMA) to announce shipping. Please send only disinfected devices or accessory parts to elexxion AG. Contaminated devices or accessory parts cannot be accepted! For transportation (carrying), lift the device on both sides by the handles and carry in an upright position.
  • Page 36: Application Tables

    16000 2,00 (special) After using fibers the dentist has to use glass rod to improve the healing. Dentitio difficilis, surgical 5W 20000 Application fiber 300µm/400µm longlife 2,50 claros-Bedienungsanleitung_ENG_V4.8 June_2022 36 / 39...
  • Page 37: Implantology

    Removal of granulation 20000 0,20 from inside the rootcanal tissue 300 um if the dentist will perform the 200 or 300 depends on the space between Retraction of gingiva 12000 0,12 the gingiva and tooth surface claros-Bedienungsanleitung_ENG_V4.8 June_2022 37 / 39...
  • Page 38: Hard Tissue

    Glass rod, ATP process is accelerated by a factor of around 4 times Suppress gag relfex 1800 Glass rod, irradiate KG24 and LG25 directly, helps for around 20 min. Root end resect./ wnd. 2000 Glass rod T8, apply directly in apex area, prevents oedema Treat. claros-Bedienungsanleitung_ENG_V4.8 June_2022 38 / 39...
  • Page 39: Notes

    Notes elexxion AG Telefon: +49 7731 90733-0 Fax: +49 7731 90733-55 Otto-Hahn-Straße 7 E-Mail: info@elexxion.com 78224 Singen www.elexxion.com claros-Bedienungsanleitung_ENG_V4.8 June_2022 39 / 39...

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