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claros
pico
user manual
claros pico
ENGLISH / V2.1 / December 2017
image subject to model
claros pico user manual V 2.1
page 1 of 34

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Summary of Contents for elexxion claros pico

  • Page 1 ENGLISH / V2.1 / December 2017 image subject to model claros pico user manual V 2.1 page 1 of 34...
  • Page 2 Forwarding and reproduction of this document and communication of its contents are not permitted unless expressly authorised by the manufacturer. All rights and utility model protection reserved. © elexxion AG claros pico user manual V 2.1 page 2 of 34...
  • Page 3: Table Of Contents

    Laser ready mode ........................18 Handling handpieces and fibers ......................19 6.4.1 ergoflex plus ..........................19 6.4.1.1 Introducing the application fibers ..................19 6.4.1.2 Adjusting the fiber length ...................... 21 claros pico user manual V 2.1 page 3 of 34...
  • Page 4 12.5 Technical data base unit: ........................27 12.6 Accuracy of values displayed: ......................27 Error messages ............................28 Calibration .............................. 28 Table of applications /setting ......................... 29 Notes ..............................34 claros pico user manual V 2.1 page 4 of 34...
  • Page 5: Labelling

    FRIWO W7556M/05 On the transmission fiber, below application part type B On side of casing: Please read operating instructions before use. Applications: Foil label on the left side of the unit: claros pico user manual V 2.1 page 5 of 34...
  • Page 6 5 W (peak) 1W (cw) laser class 4 GaAlAs diode pulse frequency: cw – 20.000Hz pulse duration: 26µs/50µs/150µs emitted wavelength: 808 nm pilot laser: 650 nm laser class 2 < 1mW IEC 60825-1:2007 claros pico user manual V 2.1 page 6 of 34...
  • Page 7: Labels On Accessories

    Foot-switch: Foil label on bottom of device application-fibers: Foil label on bottom of storage-box: Handpieces: Foil label on bottom of the storage box Laser safety glasses: Labeling / Instructions from manufacturer claros pico user manual V 2.1 page 7 of 34...
  • Page 8: Warning Notices

    Only accessories specified by elexxion AG may be used. A list of all accessories can be found in Section 6 of these instructions for use. In case of doubt, please consult your medical product consultant.
  • Page 9: Warning Notices - System Hazard

    If the intensity of the pilot beam is visibly reduced, a reduction in power output is to be expected, which will result in the loss of or a reduction in the therapeutic effect. elexxion AG's service centre should be contacted in this event.
  • Page 10: Electromagnetic Compatibility (Emc)

    General information claros pico is a class A device in accordance with CISPR 11 and is intended for use by medical specialists only. claros pico is intended for use in settings other than residential settings; the typical electromagnetic environment is that of a hospital, clinic or doctor's surgery.
  • Page 11 Table 3: Recommended safety distances between portable and mobile telecommunication devices and the claros pico system The claros pico system is designed for use in an electromagnetic environment in which RF interference is controlled. The user of the claros pico system can help to prevent electromagnetic interference by complying with the minimum distance between portable and mobile RF telecommunication devices and the claros pico system, depending on the power output.
  • Page 12: Intended Use

    Intended use claros pico is a class 4 laser device that has been developed for dental use and can be used in the following areas: » Surgery, all applications in the field of surgical incisions. » Endodontics, applications to reduce bacteria by decontaminating root canals.
  • Page 13: Protection And Safety Regulations

    The device may only be commissioned after the operator has received instruction from a laser specialist approved by elexxion, and in accordance with requirements and safety regulations. The separate instructions for use for the laser safety glasses must be observed when using laser safety glasses.
  • Page 14: Mutual Interference Risks

    Vasoconstrictors do not need to be used when administering local anaesthetic for invasive procedures. This is particularly the case when treating pregnant patients or those with pre-existing cardiac problems. claros pico user manual V 2.1 page 14 of 34...
  • Page 15: Contraindications

    Users (laser safety officers) who participate in operation courses as offered by elexxion AG are taught about the risks of laser radiation and trained in how to handle the laser device (see also "Intended use").
  • Page 16: Operation

    The foot switch is brought into service by plugging the foot switch connection lead into the socket provided on the left-hand side of the claros pico casing. Push the foot switch plug in until it reaches the stop of the device socket.
  • Page 17: Display And Display Elements

    1. Periodontology key 2. "Med" surgery key 3. Endodontics key 4. "High" surgery key The 5 program keys will turn off after a program has been activated. claros pico user manual V 2.1 page 17 of 34...
  • Page 18: Program Selection And Laser Operation

    Laser emission is activated by pressing the foot switch. The laser warning symbol on the device flashes while the foot switch is activated. A periodic warning sound beeps and laser radiation is emitted. The device switches off automatically after 10 minutes without activity claros pico user manual V 2.1 page 18 of 34...
  • Page 19: Handling Handpieces And Fibers

    6.4.1 ergoflex plus 6.4.1.1 Introducing the application fibers The claros pico 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: Purple for 200 µm/300 µm fibers...
  • Page 20 Fibers have a limited service life depending on the power output used and the fibre diameter. Fibres can typically be used up to 15 times. Disinfected fibers can be disposed of in household waste. claros pico user manual V 2.1 page 20 of 34...
  • Page 21: Adjusting The Fiber Length

    To undo the handpiece, the interlock ring must be pulled back. claros pico user manual V 2.1 page 21 of 34...
  • Page 22: Accessories

    Accessories claros pico is a diode laser system developed for dental use. It consists of a base unit, which generates the laser radiation, and a range of accessories: » claros pico: base unit including transmission fiber » ergoflex plus: handpiece for use with application fibers »...
  • Page 23: Cleaning And Sterilisation

    Lumina should be cleaned with a long, thin brush with soft bristles (i.e. a pipe-cleaner). 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. claros pico user manual V 2.1 page 23 of 34...
  • Page 24: Packaging

    Pressure: 2,1 bar Pressure: 1,1 bar Time: 5 minutes Time: 20 minutes ! PLEASE NOTE We recommend that after repeated sterilisations a suitable optical inspection is carried out (for visual damage etc.). claros pico user manual V 2.1 page 24 of 34...
  • Page 25: Maintenance

    10 Service life The claros pico 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 26: Disposal

    11.1 Packaging elexxion AG recommends retaining the unit's packaging so that it can be sent off correctly in the event of servicing. In order to dispose of packaging, please contact your elexxion AG representative or dispose of the packaging in accordance with applicable legal regulations.
  • Page 27: Technical Data Base Unit

    Storage/transport conditions: Temp. 5°C – 50 °C Rel. humidity 10 – 85 % Air pressure: 800 – 1100 hPa 12.6 Accuracy of values displayed: output: +/- 20 % from value specified claros pico user manual V 2.1 page 27 of 34...
  • Page 28: Error Messages

    Charge the battery. If the error is still present after taking this action, please contact elexxion AG service center If you send the device or accessories to elexxion AG, please go to our website at Important note: easc.elexxion.com (RMA) to register that they have been sent.
  • Page 29: Table Of Applications /Setting

    Periimplantitis, surgical Application Fiber 400µm/600µm longlife, to remove granulation tissue, assistant to provide suction Bleaching T8, 30 seconds per tooth. Use elexxion „odo bleach®“ bleaching gel. Pulse-power: 5 W / Pulse-Length: 26µs / Freq: 16 kHz surgery „med“ Average-Output: 2,0 W Curettage Application fiber 400 µm longlife, remove granulation tissue...
  • Page 30 V 2.1 page 30 of 34...
  • Page 31 Periodontitis therapy with perio green® Application fiber 300µm longlife 2 x 40 Seconds For details of treatment procedure, please see information on how to use elexxion perio green® Periimplantitis therapy with perio green® Application fiber 300µm longlife 2 x 40 Seconds For details of treatment procedure, please see informationon how to use elexxion perio green®...
  • Page 32 Glass rod T8, irradiate gingiva on both sides, 90 Seconds complete relief from pain Abrasion trauma Glass rod T8, after 2 min. haemostasis, immediate 90 Seconds improvement Sinusitis Glass rod T8, early application prevents outbreaks 60 Seconds claros pico user manual V 2.1 page 32 of 34...
  • Page 33 Glass rod T8, irraditate KG24 and LG25 directly, 60 Seconds helps for around 20 minutes Root end resection wound treatment Glass rod T8, apply directly in apex area, prevents 90 Seconds oedema claros pico user manual V 2.1 page 33 of 34...
  • Page 34: Notes

    16 Notes claros pico user manual V 2.1 page 34 of 34...

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