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Durr Dental 2032-50, Инструкция по установке и эксплуатации

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13.11 Issue clearance for the parts

for sterilisation

The reprocessing of the medical products ends
with the documented clearance for storage and
renewed use.

❯

Document the clearance of the medical prod-
uct after reprocessing.

13.12 Storing parts for sterilisation

❯

Comply with the stated storage conditions:
– Store the parts protected against contami-

nation

– Dust-protected, e.g. in a locked cabinet
– Protected against moisture
– Protected against excessive temperature

fluctuations

– Protected against damage
Packaging for a sterile medical device can suf-
fer damage as a result of a particular incident
and the passage of time.
Potential external contamination of the sterile
barrier system should be taken into account in
terms of aseptic preparation when establishing
the storage conditions.

14 Treatment breaks for more

than 24 hours

If no treatment is carried out for a period of
24 hours or more, reprocessing of the hose sys-
tem must be performed.

14.1 Cleaning and disinfecting the

hose system

The hose system is disinfected using a ready-to-
use, aldehyde-free solution of 

Vector/RinsEndo

Disinfection

.

❯

Pull off the hose connection from the hand-
piece.

❯

Lay the handpiece hose in the sink.

Rinsing with water:

❯

Fill the fluid container to approx. 1/3 with
water.

❯

Touch the RINSE (rinsing/disinfecting) button
for at least 2 seconds.

RINSE

❯

LED flashes – the rinsing process takes
around 30 seconds and ends automatically.

❯

Rinsing with water will flush out any remain-
ing blockage.

Usage

42

9000-615-32/02 2012V003

EN

Содержание 2032-50

Страница 1: ...EN Vector scaler Installation and operating instructions 0297 9000 615 32 02 9000 615 32 02 2012V003 ...

Страница 2: ......

Страница 3: ... 4 Evaluation of conformity 13 5 Operation 14 5 1 Handpiece 14 5 2 Fluid container 14 5 3 Instrument change 14 Assembly 6 Requirements 15 7 Installation 15 7 1 Establishing the electrical con nections 15 7 2 Connecting the flexible foot switch 16 8 Commissioning 17 8 1 Function check 17 8 2 Handover record 17 Usage 9 Components 18 9 1 Scaler handpiece 18 9 2 Instruments and tool kits 19 9 3 Steri ...

Страница 4: ...tion final rinse drying 40 13 8 Check for function 41 13 9 Packing 41 13 10 Steam sterilising 41 13 11 Issue clearance for the parts for sterilisation 42 13 12 Storing parts for sterilisation 42 14 Treatment breaks for more than 24 hours 42 14 1 Cleaning and disinfecting the hose system 42 14 2 Initial start up after a break in treatment for more than 24 hours 43 15 Maintenance 44 15 1 Changing th...

Страница 5: ... persons or damage to machinery The following warning symbols are used General warning symbol The warnings are structured as follows SIGNAL WORD Description of the type and source of danger Here you will find the possible conse quences of ignoring the warning Follow these measures to avoid the danger The signal word differentiates between four levels of danger DANGER Immediate danger of severe inj...

Страница 6: ...mplitude increase Disconnect all power from the unit Wear protective gloves Wear protective goggles Use a face mask Use protective clothing Rinse with water Rinse with instrument cleaner Rinse with instrument disinfectant 1 2 Copyright information All circuits processes names software pro grams and units mentioned in this document are protected by copyright The Installation and Operating Instructi...

Страница 7: ...iodontology Only agents approved by the manufacturer may be used Application with hydroxyapatite and or fluoroapa tite as polishing agent is not intended for Vector Easy Vector Easy Pro or Vector Scaler Scaler handpiece applications Subgingival and supragingival removal of den tal calculus and concrement The piezo ceramic drive of the Vector Scaler allows efficient removal of deposits while provid...

Страница 8: ...effect on the electromagnetic compatibility Mains cable 9000100846 Flexible foot switch cable 9000 119 130E NOTICE Negative effects on the EMC due to non authorised accessories Use only Dürr Dental parts or accesso ries specifically approved by Dürr Den tal Using any other accessories may result in increased electromagnetic interfer ence emissions or the unit having reduced electromagnetic immunit...

Страница 9: ... of in accordance with EU Directive 2012 19 EU WEEE If you have any questions about the correct disposal of parts please contact your dental trade supplier The unit may be contaminated Instruct the company disposing of the waste to take the relevant safety precautions Decontaminate potentially contaminated parts before disposing of them Uncontaminated parts e g electronics plastic and metal parts ...

Страница 10: ...t switch cable 6 Scaler handpiece 6a Handpiece 6b Light conductor 6c Cover 7 Handpiece hose 8 Scaler tool kit torque wrench with integra ted PREMIUMLINE instrument P1 P4 8a Torque wrench for PREMIUMLINE instru ments P1 P4 9 Scaler steri box 10 Vector Toolcard 11 Rinsing adapter for scaler instruments 12 Rinsing adapter for handpieces yellow 13 Flexible foot switch Product description 8 9000 615 32...

Страница 11: ...bles The following materials are consumed during operation of the device and must be ordered separately Vector RinsEndo Disinfection CDZ501C6150 Vector cleaner special cleaner for hose system 4 x 2 5 l CCA531A6150 FD 322 rapid surface disinfection CDF322C6150 FD 350 Classic disinfection wipes CDF35CA0140 FD 370 cleaner for medical practices CCF370C6150 FD 366 sensitive rapid surface disinfection C...

Страница 12: ...s Operating frequency kHz approx 27 32 Amplitude of Scaler handpiece μm 20 120 Duty cycle 100 Fluid container fill capacity ml 600 Scaler handpiece water consumption ml min approx 30 45 Max surface temperature of instruments C 58 Weight Basic unit kg 1 4 Scaler handpiece g approx 56 Dimensions W x H x D Basic unit cm 15 3 x 25 2 x 16 Scaler handpiece cm Ø 2 1 x 9 4 Battery for flexible foot switch...

Страница 13: ...kV AD 15 kV AD evaluation criterion B Compliant Immunity to high frequency electromagnetic fields IEC 61000 4 3 2006 A1 2007 A2 2010 80 MHz 2 7 GHz 3 V m 80 AM 1 kHz sine evaluation criterion A Compliant Immunity to near fields of wireless HF communication devices IEC 61000 4 3 2006 A1 2007 A2 2010 Refer to the table with immunity to interference levels for near fields of wireless HF communication...

Страница 14: ...voltage variations IEC 61000 4 11 2004 Compliant Immunity to interference table near fields of wireless HF communication devices Radio service Frequency band MHz Test level V m TETRA 400 380 390 27 GMRS 460 FRS 460 430 470 28 LTE band 13 17 704 787 9 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE band 5 800 960 28 GSM 1800 CDMA 1900 GSM 1900 DECT LTE band 1 3 4 25 UMTS 1700 1990 28 Bluetooth WLAN 802...

Страница 15: ...r for tool kits There is an ID number on the Scaler tool kits The ID number serves to document the reproc essing These parts may no longer be used after a cer tain number of reprocessing cycles or after the end of the service life The ID number is made up of the following mark ing MMXXXX MM Date of manufacture year and month XXXX Consecutive alphanumerical ID number Scaler tool kit 4 4 Evaluation ...

Страница 16: ...into the front section of the handpiece As soon as the flexible foot switch is switched on and Power is selected on the operating panel the LEDs light up The LEDs go out approx 4 seconds after the flexible foot switch is released 5 2 Fluid container The fluid level is monitored via a sensor When the level drops to a minimum level the LEDs in the area of the fluid container flash and a warning sign...

Страница 17: ...ted in the recess on the rear of the unit Requirements ü Correctly installed power outlet in the vicinity of the unit max length of mains cable 3 m ü The plug connection of the power supply is freely accessible so that it can be quickly dis connected in the event of danger ü Mains voltage must match the information shown on the type plate of the power supply unit ü The supply voltage of the power ...

Страница 18: ...ry If interference does occur during wireless operation we recommend using the flexi ble foot switch with foot switch cables Wireless operation is not possible if the foot switch cable is connected to either the unit or the flexible foot switch CAUTION Risk of injury Mixing up flexible foot switches can cause malfunctions such as the acci dental operation of a different hand piece This can cause i...

Страница 19: ...ents ü No foot switch cable must be connected to the device or to the flexible foot switch ü The orange PEDAL LED is not on or is not flashing Switch off the device Touch the LIQUID operating panel keep touch ing it and switch on the device Result When the orange PEDAL LED flashes this shows that the current pairing has now been cancelled 8 Commissioning 8 1 Function check To finish the initial st...

Страница 20: ...d is applied as a constant stream Settings POWER RINSE CLEAN LIQUID PEDAL FUNCTION POWER The power is adjusted in the POWER operating panel The Vector Scaler handpiece enables optimum adjustment of the ultrasonic power according to the medical indication in conjunction with the cor responding instrument The power can be adjusted between 5 settings on the Scaler handpiece POWER Operating frequency ...

Страница 21: ...ction at the hand piece 9 2 Instruments and tool kits Overview Instruments of various shapes lengths and mate rials are available These are grouped according to their different applications and arranged in the tool kits These instruments are specially designed for use with the Vector Scaler device No other instruments must be used P1 P2 P3 P4 14 15 14 Scaler tool kit torque wrench with integra ted...

Страница 22: ...lisation packaging in accordance with DIN11607 1 and seal The rubber clips on the carrier plate can be replaced if necessary 9 4 Flexible foot switch The handpieces are operated with the flexible foot switch In wireless operation the flexible foot switch is supplied with voltage from a battery If the battery power starts to fail the orange PEDAL LED on the unit lights up Interference can occur in ...

Страница 23: ...ater based active ingredient the unit should be thoroughly rinsed using warm water 9 6 Cleaning components Vector RinsEndo Disinfection Ready to use aldehyde free solutions for fast action disinfection and cleaning of Vector hose systems The undiluted solution is poured into the fluid container These measure must be car ried out before breaks in treatment of more than 24 hours 12 2 Activating the ...

Страница 24: ... RINSE rinsing disinfecting To start the rinsing process touch the button for at least 2 seconds The blue LED flashes during the rinsing process 14 CLEAN After approx 30 operating hours the blue LED will light up continuously this shows that it is time for clean ing To start the cleaning process touch the button for at least 2 seconds The blue LED flashes during the cleaning process Recommendation...

Страница 25: ...e The LEDs for POWER and LIQUID are only active and light up when a handpiece is inserted If no handpiece is inserted the settings for POWER and LIQUID cannot be adjus ted ON Standby The unit can be switched on or into standby mode via the operating panel ON Standby The unit is equipped with an automatic standby mode in order to save electricity When the unit is left unused for 30 minutes it switc...

Страница 26: ... lights up the battery power must be checked 15 4 Inserting or changing the battery in the flexible foot switch If the orange LED flashes then no flexible foot switch is connected or paired FUNCTION If the orange LED lights up the contact pressure of the instrument is too high or the handpiece needs to be checked 10 3 Preparing the device for treat ment Switch on the unit WARNING Risk of cross con...

Страница 27: ...The tool kit cover of the instrument is used as a torque wrench for tightening the union nut of the instrument chuck Select a suitable instrument for the corre sponding treatment To prevent the instrument from being overtightened the torque wrench slips when the required torque is reached No ratcheting sound can be heard Always use the torque wrench to screw the instrument on and off When screwing...

Страница 28: ...burns During operation some of the compo nents inside the handpiece heat up Contact with hot parts can cause burns Only operate the Scaler handpiece with the cover fitted and intact During treatment using the Scaler handpiece fluid is applied as a constant stream 11 3 Use of the Scaler instruments b a a Contact angle approx 10 b Working area 2 mm The active working area of the instrument is in the...

Страница 29: ...ction to pro vide good visibility of the field of treatment Application areas CAUTION Risk of injury Accidental activation or uncontrolled activities of the handpiece can cause injuries Insert the handpiece in the handpiece holder when it is not in use Dismantle the instrument or push on the torque wrench Scaler instrument P1 30 mm straight for the removal of subgingival deposits in deep gingi val...

Страница 30: ...oiled Surface of the device Handpiece hose Fluid container Tool kit for Scaler without instruments As the surface disinfectant we recommend using a disinfectant that is compatible with the materi als and meets the general dental hygiene stand ards e g Dürr Dental FD 322 rapid surface disinfectant Dürr Dental FD 350 disinfection wipes Dürr Dental FD 366 sensitive rapid surface dis infectant NOTICE ...

Страница 31: ...pty fluid con tainer 2x Touch the CLEAN button for at least 2 sec onds CLEAN 1x LED CLEAN and the LED in the fluid container flash and a clicking sound is heard The device is cleaned for approx 10 minutes with Vector cleaner until the fluid container is empty The process ends automatically LED RINSE lights up and a cyclically repeating warning signal sounds as an indication that the device must be...

Страница 32: ... will come on every time the device is switched on 12 3 Cleaning the fluid container The fluid container should regularly cleaned and descaled How soon descaling is required depends primar ily on the hardness of the water used However at the latest descaling must be performed when first signs of limescale become apparent Cleaning Fill up the fluid container to the upper mark ing with cleaning solu...

Страница 33: ...ece hose from the hand piece Unscrew and remove the sleeve part Clean the sleeve part and the adapter of the handpiece hose with a hygienic soft brush and a moist lint free cloth Screw sleeve back in place Push the handpiece hose onto the handpiece Usage 9000 615 32 02 2012V003 31 EN ...

Страница 34: ...n accordance with the prepara tion process set out in ISO 17664 Important information The reprocessing notes in accordance with ISO 17664 have been independently tested by Dürr Dental for the preparation of the device and its components for their reuse The person conducing the reprocessing is responsible for ensuring the reprocessing performed using the equipment materials and personnel achieves t...

Страница 35: ...l Comply with all national directives standards and specifications for the cleaning disinfection and sterilisation of medical products as well as the specific specifications for dental practices and clinics Comply with the specifications see 13 6 Man ual cleaning intermediate rinsing disinfection final rinse drying in ultrasonic bath and 13 7 Automatic cleaning intermediate rinsing disin fection f...

Страница 36: ...nds automatically Pre cleaning Do pre cleaning of handpiece and acces sories no more than 15 minutes after the unit has been used Clean the exterior surfaces completely with two cleaning cloths Make sure that the surfa ces are sufficiently moistened Note the action time of the cleaning agent Perform the procedure twice Draw 3 x 20 ml cold water temperature 20 C into a conventional sterile 20 ml di...

Страница 37: ...of the tool kits without instruments and the disassembled handpiece in the cleaning bath for the required reaction time so that all parts are covered Clean all accessible external surfaces and inter nal surfaces below the surface for 5 minutes with a hygienic cleaning brush until all visible soiling has been removed Place instruments in small parts baskets into the cleaning bath Rinse handpiece th...

Страница 38: ... water using a 20 ml disposable pipette 20 ml Disinfection Place the removable parts of the handpiece Scaler cover light conductor instrument hold ers of the tool kits without instruments and the disassembled handpiece in the cleaning bath for the required reaction time so that all parts are covered Clean all accessible external surfaces and inter nal surfaces below the surface for 5 minutes with ...

Страница 39: ...ed for manual cleaning and disinfection It must have the following properties certified possibly virucidal efficacy DVV RKI VAH or European Standards without chlorine without solvent no strong alkaline solutions pH 11 no strong oxidis ing agents For further information see General informa tion Cleaning in an ultrasonic bath NOTICE Malfunctions in the handpiece due to improper handling during clean...

Страница 40: ... Screw Scaler instruments onto the rinsing adapter one after another and rinse through each of the instruments at least 3 times using a 20 ml disposable syringe 20 ml Comply with the cleaning agents action times specified by the manufacturer Intermediate rinsing After the action time prescribed by the manufac turer Rinse all components under running water for at least 1 minute temperature 20 C Rin...

Страница 41: ...ll parts baskets into the ultrasonic bath Place the handpiece without covers in a con tainer with fluid The drive mechanism of the handpiece must not lie in the fluid malfunc tion Therefore observe instructions concern ing maximum fluid level for the Scaler hand piece max Place container with the handpieces in the ultrasonic bath with a suitable carrier Rinse handpieces through at least 3 times us...

Страница 42: ...of the machine cleaning agents and disinfectants The following properties are required Material compatibility with the product Corresponds with the manufacturer s specifi cations of the CD For further information see General informa tion Automatic cleaning and disinfecting When arranging the parts in the washer disinfector make sure there are no areas missed by rinsing Attach the handpiece to the ...

Страница 43: ...effective The use of instruments that have not been properly sterilised can pose a health risk to the patient Only steam sterilisation must be used Comply with all of the specified proc ess parameters Comply with the manufacturer s instructions regarding use of the steam steriliser Do not use any other methods NOTICE Damage to equipment due to incor rect sterilisation If the sterilisation process ...

Страница 44: ...ion of the sterile barrier system should be taken into account in terms of aseptic preparation when establishing the storage conditions 14 Treatment breaks for more than 24 hours If no treatment is carried out for a period of 24 hours or more reprocessing of the hose sys tem must be performed 14 1 Cleaning and disinfecting the hose system The hose system is disinfected using a ready to use aldehyd...

Страница 45: ...n 24 hours The initial start up process will depend upon whether the hose system was reprocessed before the break in treatment Proceed as follows depending on the situation 1 Reprocessing performed before the treat ment break Rinse the system with water Thorough rinsing with water will flush out any disinfectant remaining in the hoses and any irritation to the patient caused by the taste of residu...

Страница 46: ...nt of leaks loose seating or visible damage the O ring must be replaced Insert the valve in the holder and tighten it clockwise as far as it will go 15 2 Checking instrument wear Instrument wear can be checked using the Vec tor toolcard Place the handpiece against the toolcard If the instrument tip extends beyond the red marking then the instrument can still be used If the instrument tip just reac...

Страница 47: ... can be sterilised sev eral times As soon as it starts to become opaque or take on a milky colour light transmission begins to decrease Unscrew the cover Disconnect the light conductor Connect a new light conductor Screw on the cover 15 4 Inserting or changing the bat tery in the flexible foot switch A new battery should be inserted in the flexible foot switch prior to initial start up in wireless...

Страница 48: ...vi ronmentally friendly disposal Do not throw batteries away with domestic waste Take out the battery from the holder and dis pose of it in an environmentally friendly way Inserting the battery Insert the battery in the holder Make sure that the battery is inserted with the correct polarity Closing the cover Make sure that the two pedal return springs are present and correctly positioned If they a...

Страница 49: ...ble foot switch is empty Check battery performance and insert a new battery if necessary Interference caused by external wireless signals Operate the flexible foot switch using the foot switch cable The wireless module in the flexi ble foot switch is defective Operate the flexible foot switch using the foot switch cable or call a Service Techni cian The wireless module in the basic unit is defecti...

Страница 50: ...om the handpiece hose Replacing the sealing screw Fluid leaks out between Scaler handpiece and instru ment Scaler instrument was not screwed on with the full torque Screw on the Scaler instru ment correctly Scaler instrument has become loose Screw the Scaler instrument in place correctly If there are signs of wear replace the instrument Fluid leaks between hand piece and handpiece hose during oper...

Страница 51: ...ed cable operation or paired wireless operation Connect a flexible foot switch cable operation or perform pairing wireless operation Blue CLEAN LED continues to light up after a cleaning program has been carried out The CLEAN function of the cleaning process was not fully completed or it was stopped early Carry out the cleaning proc ess CLEAN in full The blue POWER and LIQ UID LEDs fail to light u...

Страница 52: ...ame Order number REF Serial number SN o Visual inspection of the packaging for any damage o Unpacking the medical device and checking for damage o Confirmation of the completeness of the delivery o Instruction in the proper handling and operation of the medical device based on the operating instructions Notes Name of person receiving instruction Signature Name and address of the qualified adviser ...

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Страница 56: ...Hersteller Manufacturer DÜRR DENTAL SE Höpfigheimer Str 17 74321 Bietigheim Bissingen Germany Fon 49 7142 705 0 www duerrdental com info duerrdental com ...

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