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claros pico user manual V 2.1 

 

 

 

 

 

 

 

 

page 13 of 34 

 
 

5

 

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. 

 
 
5.1

 

Side-effects 

 
- Carbonisation / necrosis zones: 

High outputs (> 1 W) and/or exposure of one area over a longer period of time can result in irreversible tissue 
damage due to carbonisation and necrosis exceeding the desired level. Measures: move the fiber in a controlled 
manner; select a weaker output program! 

 

- Unpleasant odour formation: 

Vaporisation of tissue caused by intended photothermal effect. Measures: use suction! 

 

- Noise levels (surgery only): 

Cutting noise caused by vaporisation of tissue. Measures: none, noise unavoidable 

 

- Warming of hard tissue, destruction in some cases (surgery only): 

Side-effect that may arise when employing the device outside its intended use caused by harmful warming of hard 
tissue (tooth, bone) at high power outputs and over a long duration. Measures: use surgery programs in accordance 
with intended use and operating instructions; process hard tissue according to the intended program only! 

 

 

Содержание claros pico

Страница 1: ...claros pico user manual V 2 1 page 1 of 34 claros pico user manual claros pico ENGLISH V2 1 December 2017 image subject to model ...

Страница 2: ...0 7731 90733 0 Fax 0049 0 7731 90733 55 E mail info elexxion com Serial no 35 xxxx Version V 2 0 Release date V 2 1 December 2017 0086 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 ...

Страница 3: ... regulations 13 5 1 Side effects 13 5 2 Mutual interference risks 14 5 3 Contraindications 15 5 4 Summary assessment of residual risks 15 5 5 Handling rechargeable batteries 15 5 5 1 Replacing the battery 15 5 5 2 Charging the battery 15 5 5 3 Operating time 15 5 5 4 Disposal 15 6 Operation 16 6 1 Commissioning 16 6 2 Display and display elements 17 6 3 Program selection and laser operation 18 6 3...

Страница 4: ...e life 25 11 Disposal 26 11 1 Packaging 26 11 2 Device 26 12 Technical data 26 12 1 Description of the beam guiding system 26 12 2 Laser aperture 26 12 3 Disconnection from the mains charging mode 26 12 4 Technical data power supply 26 12 5 Technical data base unit 27 12 6 Accuracy of values displayed 27 13 Error messages 28 14 Calibration 28 15 Table of applications setting 29 16 Notes 34 ...

Страница 5: ...cture Serialnumber Partnumber Application Part Type B Do not dispose with household waste Protection class II Protectionisolation Power supply Foil label on side of the unit 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 5 V DC 3A max FRIWO W7556M 05 ...

Страница 6: ... yellow black on back of base unit Visible and invisible laser radiation Avoid irradiating eyes or skin with direct or scattered radiation laser class 4 IEC 60825 1 2007 Visible and invisible laser radiation emitted from this aperture Laser radiation do not stare into bam laser class 2 maximum output 5 W peak 1W cw laser class 4 GaAlAs diode pulse frequency cw 20 000Hz pulse duration 26µs 50µs 150...

Страница 7: ...f 34 1 2 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 ...

Страница 8: ... glasses see item 2 while the laser is being used 7 Use is only permitted in rooms designed for medical purposes and which meet the above requirements Use anywhere else is not allowed 8 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 9 Use of the o...

Страница 9: ...rs is limited Pressing bending stretching or compressing the fibers too heavily can cause them to break 32 Applicators must not be replaced while the device is ready for use and a program activated as the emission switch may be activated by accident 33 The battery may only be replaced by authorised elexxion AG service personnel Replacing the battery yourself may leave the device in a dangerous con...

Страница 10: ...s and how to prevent them The claros pico system uses RF energy for its own operation only The amount of radio frequency interference emitted is therefore very low and is unlikely to disturb other devices being operated in the vicinity Nevertheless it should be noted that simultaneous operation of the claros pico system together with other devices may result in interference in the claros pico syst...

Страница 11: ...c 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 telecommun...

Страница 12: ...grammed and cannot be changed A list of the various application programs can be found in the appendix to these operating instructions Dentists are the designated users of the laser system They must be taught about the risks of laser radiation and trained in how to handle the laser device laser safety officer The laser may be used in a laser protection area only all individuals located in this area...

Страница 13: ...ue to carbonisation and necrosis exceeding the desired level Measures move the fiber in a controlled manner select a weaker output program Unpleasant odour formation Vaporisation of tissue caused by intended photothermal effect Measures use suction Noise levels surgery only Cutting noise caused by vaporisation of tissue Measures none noise unavoidable Warming of hard tissue destruction in some cas...

Страница 14: ...of results and incompatibility with consumables and other products Low risk 1 Hazards due to malfunctions maintenance and ageing caused by insufficient performance features for planned use inadequate maintenance lack of appropriate assessment as to when the device s service life will expire loss of mechanical integrity substandard packaging contamination and unsuitable reuse Low risk 2 1 Definitio...

Страница 15: ... Replacing the battery The battery may only be replaced by authorised elexxion AG service personnel Replacing the battery yourself may leave the device in a dangerous condition Caution risk of fire and explosion 5 5 2 Charging the battery The battery must be fully charged using the charger supplied before being used for the first time A charging cycle takes up to 3 5 hours The battery display will...

Страница 16: ...s displayed in the top right hand corner of the display The indicator will flash during charging The battery charging level is permanently displayed after charging is complete 4 A visual warning is displayed when only a limited amount of battery charge is left The charging level indicator will flash rapidly Active operation of the laser is possible for a maximum of 5 minutes after this time 5 The ...

Страница 17: ...ode should then be entered The code consists of the following key combinations 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 Battery Status Display Application Periodontology Application Endodontics Laser Active Warning Application surgery low Application surgery high Application surgery med LASER STO...

Страница 18: ...lication table page 26 Laser stop button Stops radiation emission immediately in any operating status 6 3 3 Laser warning mode After confirming the specific program the device displays a flashing laser warning symbol This mode lasts 2 seconds From this point in time everyone in the laser protection area must wear suitable safety glasses 6 3 4 Laser ready mode Following the laser warning mode the l...

Страница 19: ... 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 Green for 400 µm 600 µm fibers Push application fibers carefully into the handpiece front part from behind as far they will go Cauti...

Страница 20: ...beforehand To remove the handpiece front part the interlock ring must be pulled to the rear The handpiece front part can now be removed Carefully pull the fiber out of the handpiece front part and have it be disinfected The fibers can be changed during operation with the device switched on Fibres must not be replaced during laser emission under any circumstances Fibers have a limited service life ...

Страница 21: ...cable and pull the fiber out of the handpiece Do not adjust the fiber length when the tube is bent 6 4 2 ergo T The ergoT handpiece can be used with the two glass rods T4 optional and T8 The glass rods are used in all therapy programs and for bleaching The application information on the list of applikations shows which glass rod is used in the relevant program To insert the glass rod undo the fixi...

Страница 22: ...go T handpiece for use with glass rod T8 Soft metal tips single use tips for guiding the application fibers in ergoflex plus Bending tool tool used to bend the soft metal tips elexxion longlife 200 300 400 600 µm application fibers Glass rod T8 applicator glass rod 8 mm in diameter claros protect laser safety glasses claros pico step foot switch Table stand Mains adapter charger Wall sign pico Eur...

Страница 23: ...e made entirely or partly of plastic to come into contact with strong acids or bases organic or ammonia containing solvents aromatic and or halogen containing hydrocarbons or oxidising chemicals Do not allow aluminium or materials that contain aluminium to come into contact with any substances that contain mercury Even the slightest trace of mercury can cause considerable corrosion Instruments mad...

Страница 24: ...e a visual inspection using a magnifier is recommended according to the RKI 8 1 1 Packaging Packaging that is suitable for the instrument application fibres glass rod and the sterilisation procedure should be selected Instruments with restrictions in terms of their frequency of use should be labelled accordingly in order to ensure clear allocation for the purpose of the QM system The packaging mus...

Страница 25: ...ranty and liability claims on the part of the manufacturer shall also expire All maintenance work must be performed by providers that have been authorised by elexxion AG to maintain the device type in question Authorised maintenance providers elexxion AG Otto Hahn Straße 7 78224 Singen Germany Tel 49 7731 90733 0 Fax 49 7731 90733 55 E mail info elexxion com Contact information can also be found o...

Страница 26: ...llium aluminium arsenide GaAlAs The divergent beam is focused internally on a defined point in front of the laser aperture by a multiple lens system By inserting an optical fibre with NA numerical aperture 0 22 or 0 37 and an SMA screw connection the focal point is projected onto the fibre input plug and the beam is guided to the application end of the fiber with virtually no losses by means of to...

Страница 27: ...class I application part type B IP 00 Wavelength 808 nm 10 nm Max power output pulse 5 W Max power output CW 1 0 W Pulse frequency CW 20 000 Hz Pulse duration 26 µs 50 µs 150 µs Aiming beam 650 nm 5 nm 1mW Operating conditions Temp 15 C 35 C Rel humidity 20 85 Air pressure 800 1100 hPa Storage transport conditions Temp 5 C 50 C Rel humidity 10 85 Air pressure 800 1100 hPa 12 6 Accuracy of values d...

Страница 28: ...ces or accessories to elexxion AG Contaminated devices and accessories cannot be accepted 14 Calibration Power calibration takes place during the annual technical safety inspection Power calibration is not normally necessary outside these periods However if power calibration is necessary because clear power deviations are observed the following procedure should be used Please note that class 4 las...

Страница 29: ...µm longlife irradiate membrane extensively at short distance max 20 seconds Surgery low Pulse power 5 W Pulse Length 26µs Freq 12 kHz Average Output 1 5 W Decontaminate implants Application fiber 200µm 300µm longlife move around to cover all areas if possible Periimplantitis surgical Application Fiber 400µm 600µm longlife to remove granulation tissue assistant to provide suction Bleaching T8 30 se...

Страница 30: ...claros pico user manual V 2 1 page 30 of 34 ...

Страница 31: ...immediately Sample biopsies Application fiber 400µm longlife stretch tissue wedge excision Retention cysts Application fiber 300µm longlife remove cyst sac undamaged if possible Expose impacted teeth Application fiber 400µm longlife expose impacted teeth soft tissue only perio green Pulse power 1 W Pulse Length 150µs Freq 2 kHz Average Output 0 3 W Periodontitis therapy with perio green Applicatio...

Страница 32: ...ds Herpes labialis Glass rod T8 dry blisters tension eases 2 3 treatments 60 Seconds Temporomandibular joint disorders Glass rod T8 pain relief but does not remedy cause 2 treatments 60 Seconds Relieve lockjaw Glass rod T8 irradiate each side hold directly on joints 60 Seconds Jaw osteitis Glass rod T8 prevention of post extraction pain irradiate entire surgical area 2 treatments 45 Seconds Smooth...

Страница 33: ...T8 rapid reduction in inflammation 5 treatments 60 Seconds Wound healing Glass rod T8 ATP process is accelerated by a factor of around 4 120 Seconds Suppress gag reflex Glass rod T8 irraditate KG24 and LG25 directly helps for around 20 minutes 60 Seconds Root end resection wound treatment Glass rod T8 apply directly in apex area prevents oedema 90 Seconds ...

Страница 34: ...claros pico user manual V 2 1 page 34 of 34 16 Notes ...

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