elexxion claros nano Manual

Dental laser

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Device/type:

claros nano dental laser

Manufacturer:

elexxion AG

Otto-Hahn-Str. 7

78224 Singen,

Germany

Tel. +49 7731 907330

Fax +49 7731 9073355

E-mail:

info@elexxion.com

Serial no:

04-

Software version:

V 1.06

Release/date:

V 3.3 / 2022-06

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.

nano-Bedienungsanleitung_ENG_V3.3_June_2022

Page 1 of 40

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Summary of Contents for elexxion claros nano

Page 1 Device/type: claros nano dental laser Manufacturer: elexxion AG Otto-Hahn-Str. 7 78224 Singen, Germany Tel. +49 7731 907330 Fax +49 7731 9073355 E-mail: info@elexxion.com Serial no: Software version: V 1.06 Release/date: V 3.3 / 2022-06 Forwarding and reproduction of this document and communication of its contents are not permitted unless expressly authorised by the manufacturer.
Page 2: Table Of Contents
Contents Overview ............................. 4 Labelling and warning notices ......................5 2.1. Labels on the device ........................5 2.2. Labels on the accessories ......................7 2.3. Warning notices - danger to persons ..................9 2.4. Warning notices - system hazard .................... 10 2.5.
Page 3 6.7. Device reset (default settings) ....................27 Accessories ............................28 Cleaning and sterilisation ........................28 8.1. Cleaning ............................. 28 8.1.1. Packaging ........................... 30 8.2. Sterilisation ..........................31 Maintenance ............................31 10. Service life............................32 11. Disposal.............................. 32 11.1. Packaging ..........................32 11.2.
Page 4: Overview
1. Overview 1. User interface 6. Transmission fiber reel 2. Handpiece holder 7. Foot switch connection 3. Fiber connection (laser aperture) 8. Power supply 4. Ventilation opening 9. Interlock connection 5. Laser stop button nano-Bedienungsanleitung_ENG_V3.3_June_2022 Page 4 of 40...
Page 5: Labelling And Warning Notices
2. Labelling and warning notices 2.1. Labels on the device type label: foil label on bottom of device YYYY-MM Symbol Description Manufacturer Date of Manufacture Serialnumber Partnumber Application Part Type B Do not dispose with household waste General waning sign Follow instruction for use Laser warning sign, laser radiation Avoid eye exposure to direct or...
Page 6 Power supply: foil label on back of device Fuses: foil label on back of device Foot switch connection: foil label on back of device Interlock connection: foil label on back of device Laser type: foil label, yellow/black, on back of device: Maximum output: 15W (peak), 7W (CW) Laser class 4 GaAlAs diode...
Page 7: Labels On The Accessories
2.2. Labels on the accessories Foot switch: foil label on bottom of foot switch Application fibers: foil label on bottom of packaging: nano-Bedienungsanleitung_ENG_V3.3_June_2022 Page 7 of 40...
Page 8 Handpieces: Foil label on bottom of the storage box Laser safety glasses: Labeling / Instructions from manufacturer nano-Bedienungsanleitung_ENG_V3.3_June_2022 Page 8 of 40...
Page 9: Warning Notices - Danger To Persons
- Visible and invisible laser radiation Laser class 4. Irradiation of eyes and skin by direct or stray radiation! - Only accessories specified by elexxion AG may be used. A list of all accessories can be found in Section 7 Accessories of these instructions for use. In case of doubt, please consult your medical product consultant.
Page 10: Warning Notices - System Hazard
such as those contained in adhesives and flammable solutions that are used for cleaning or disinfection purposes, should be given time to evaporate before the laser device is operated. - Gases produced by the body can also be flammable! - Applicators and handpieces must be decontaminated using an autoclave or by spraying/wiping with disinfectant before they are first brought into service and before and after each use.
Page 11: Warning Emc
and handpieces. The display can be treated in the same way. 2.5. Warning EMC - Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally”.
Page 12: Electromagnetic Compatibility (Emc)
3. Electromagnetic compatibility (EMC) 3.1. 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 Table 1: Emission Phenomenon Compliance Electromagnetic environment CISPR 11 RF emissions Professional healthcare facility environment Group 1, Class A IEC 61000-3-2 Harmonic distortion Professional healthcare facility environment Class A Voltage fluctuations IEC 61000-3-3 Professional healthcare facility environment and flicker Compliance Table 2: Enclosure port Immunity test levels Phenomenon...
Page 14 Table 4: Input a.c. power Port Immunity test levels Phenomenon Basic EMC standard Professional healthcare facility environment Electrical fast ±2 kV IEC 61000-4-4 transients/burst 100kHz repetition frequency Surges IEC 61000-4-5 ±0.5 kV, ±1 kV Line-to-line Surges IEC 61000-4-5 ±0.5 kV, ±1 kV, ±2 kV Line-to-ground Conducted 3V, 0.15MHz-80MHz...
Page 15: Intended Use
4. Intended use Elexxion Claros nano 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 •...
Page 16: Protection And Safety Regulations
5. Protection and safety regulations The device may be commissioned only after the operator has received instruction, 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 17: Contraindications
failure to follow manufacturer’s recommendations may lead to damage to the fiber or delivery system and/or harm to the patient or laser operator Minimal risk - Biological hazards: minor risk (caused by bio-burden, bio-incompatibility, incorrect supply (substance, energy), toxicity, infection, pyrogenicity and decomposition of material) - Environmental hazards: minor risk [caused by electromagnetic interference, inadequate energy supply (excess voltage or undervoltage), limited cooling, operation outside prescribed environmental conditions,...
Page 18: Summary Assessment Of Residual Risks
With due regard to the potential side-effects, the resulting residual risks in terms of hazards are deemed acceptable in due consideration of the intended application and use of the laser system and accessories. As a result, no restrictions have been specified for use of the claros nano system in accordance with its intended use.
Page 19 The foot switch and interlock connection may be removed and reconnected during operation. The emission of laser radiation is not possible without the foot switch or interlock. nano-Bedienungsanleitung_ENG_V3.3_June_2022 Page 19 of 40...
Page 20: Display Test
6.2. Display test A display test is performed at each system start (power supply connected). All symbols/segments are displayed simultaneously for 3 seconds. 6.3. Display elements 1 – PIN; parameter display 2 – Program selection/application areas 3 – Pulse mode display 4 –...
Page 21: Program Selection And Laser Operation
6.4. Program selection and laser operation 6.4.1. Standby mode After connecting the device to the power supply with the power cord, a display test (all symbols on for 3 seconds) is performed. Next, the firmware version is indicated in the display. After this, the system changes automatically into standby mode.(ON/OFF button turns orange).
Page 22: Laser Warning Mode
6.4.4. Laser warning mode After confirming the specific program, the device displays a flashing laser warning symbol along with a flashing laser safety glasses symbol. This serves as a reminder that suitable laser safety glasses must be worn. A warning tone sounds simultaneously. This mode lasts 2 seconds. Attention! From this point in time, activating the foot switch will result in emission of laser radiation.
Page 23: Changing Program Parameters
6.4.6. Changing program parameters Select program whose parameters are to be changed and confirm with the OK button (laser ready mode Press program symbol button for more than 2 seconds. The program parameter setting mode is activated and the 'Pulse output' parameter begins to flash.
Page 24: Handling The Handpieces
6.6.1. ergoflex plus 6.6.1.1. Introducing the application fibers The claros nano 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
together in the handpiece longitudinal direction until the interlock ring can be heard to engage. The fiber can be removed after use. (To do so, ensure that the soft metal tip has been bent straight again or removed beforehand.) To remove the handpiece front part, the interlock ring must be pulled to the rear.
Page 26: Ergo T
part 2 and twist part 3 to adjust the fiber length. Turning clockwise => increases the fiber length; Turning anticlockwise => shortens the fiber length. When you have reached the desired fiber length, lock the handpiece by twisting parts 1 and 2 clockwise.
Page 27: Device Reset (Default Settings)
To undo the handpiece, the interlock ring must be pulled back. 6.7. Device reset (default settings) The procedure below can be followed to reset the customer PIN to 000 and the output parameters to the default settings: In standby mode, keep the buttons (not shown) "Endodontics" and "LLLT" (first and fourth rows) pressed and activate the foot switch at the same time.
Page 28: Accessories
7. Accessories claros nano 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: Article No. Article 11199 nano: base unit including transmission fiber 11317-01...
Page 29 • Thoroughly clean and dry re-usable instruments immediately after use to minimise corrosion and possible cross-contamination. • Validation of the cleaning, sterilisation and re-sterilisation processes and the correct setup of the corresponding devices must be checked regularly. • Do not allow instruments to come into contact with any substances that contain chlorine or fluorine.
Page 30: Packaging
Rinsing 1: at least two minutes with water Rinsing 2: at least one minute with water Disinfection: 5 minutes, 15,5 l water (≤ 3µS / cm), 90° C Drying: 15 minutes, 95° C air inlet temperature The automated reprocessing of cannulated parts or hollow bodys (e.g. handpieces) is done by the specifications and with the tools of the manufacturer of the cleaning unit (e.g.
Page 31: Sterilisation
Safety concept test in accordance with 'nano testing' operating instructions in force 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.
Page 32: Service Life
10. Service life The claros nano 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 33: Technical Data
Laser emission may be started only when the handpiece and inserted fiber or glass rod are connected. Glass rods T4 and T8 may not be used for applications other than those that are described (therapy). claros nano technical data: Dimensions: 22x18.5x21 cm (HxWxD)
Page 34 Accuracy of values displayed: - Power output: +/- 20% of display value - Frequency: +/- 3% of display value - Time: +/- 3% of display value - Temperatures: +/- 5% of display value nano-Bedienungsanleitung_ENG_V3.3_June_2022 Page 34 of 40...
Page 35: Error Messages
Close door 'Check interlock' interlock plug Insert interlock connector Fault in beam attenuator Contact elexxion Service if this occurs 'Shutter does not open' more than once. Fault in beam attenuator Contact elexxion Service if this occurs 'Shutter does not close' more than once.
Page 36: Calibration
If the device or accessories are to be sent to elexxion, please clarify the packaging and shipping modalities with elexxion beforehand. Please send only disinfected devices and accessories to elexxion. Contaminated devices and accessories cannot be accepted. 14. Calibration Power calibration takes place during the annual technical safety inspection. A power calibration is not normally necessary outside these periods.
Page 37: Application Table/Default Settings
15. Application table/default settings Pulse Pulse Endodontology Applicator Average output output frequency 200 μm, open canal minim. ISO 30, dry it with paper tip Bacterial 1.5 W and move from apex under circulating motion out of canal 1.5 W reduction in canal with 30 sec.
Page 38 Pulse Pulse Surgery Applicator Average output output frequency Surgery, general 15.0 W 20 kHz 400/600 μm tighten the tissue 5.10 W Gingivectomy 15.0 W 15 kHz 400/600 μm 3.83 W before impression Frenectomy 15.0 W 12 kHz 400/600 μm, tighten frenulum 3.06 W 300/400 μm, from center of screw outward, impression can Expose implant...
Page 39 Dentitio difficilis, 20 kHz Application fiber 300µm/400µm longlife 2.5 W surgical S07- 1W (cw) Pulse Pulse LLLT Applicator Average output output frequency Healing of wounds 8 kHz glass rod under contact for 120 sec. 0.08 W Pain in general 9 kHz glass rod under contact for 100 sec.
Page 40 Glass rod T8, after 2 min. haemostasis, immediate Abrasion trauma improvement, 90 Seconds Glass rod T8, rapid reduction in inflammation, 5 Stomatitis treatments, 60 Seconds Root end resection Glass rod T8, apply directly in apex area, prevents wound treatment oedema, 90 Seconds L04- 1W(cw) nano-Bedienungsanleitung_ENG_V3.3_June_2022...

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