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Durr Dental Vector Scaler, Инструкция по установке и эксплуатации

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36 

9000-615-32/02  1808V002 

Usage

Requirements placed on the steam steriliser:

 

– Corresponds to EN 13060 or EN 285 and/or 

ANSI AAMI ST79

 

– Suitable programme for the products listed 

(e g  with hollow bodies, fractionated vacu-
um procedure in three vacuum steps)

 

– Sufficient product drying

 

– Validated process in accordance with DIN EN 

ISO 17665 (valid IQ/OQ and product-specific 
performance appraisal (PQ)

Perform the following steps:

 

i

Sterilise the parts for sterilisation (at least  
20 minutes at 121 °C, at least 4 minutes 
at 132 °C or at least 5 minutes at 134 °C) 

 Do not exceed 138 °C

Marking

 

i

Mark the packaged, treated medical product 
in such a way as to ensure safe application

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

 

i

Document the clearance of the medical prod-
uct after reprocessing

13.12  Storing parts for sterilisation

 

i

Comply with the stated storage conditions:

 

– Store the parts protected against contami-

nation

 

– Dust-protected, eg in a locked cabinet

 

– Protected against moisture

 

– Protected against excessive temperature 

fluctuations

 

– Protected against damage
Packaging for a sterile medical device can 
suffer damage as a result of a particular inci-
dent and the passage of time  
Potential external contamination of the sterile 
barrier system should be taken into account 
in terms of aseptic preparation when estab-
lishing the storage conditions

13.9 Packing

CAUTION
Endangering the sterilisation success

The fitted components are not reached 
by the steam and as such are not steri-
lised

 

i

Do not fit the components before 
packaging

For packaging of the components, use only 
sterile barrier systems made of transparent 
paper film that are approved for use in steam 
sterilisation according to the manufacturer infor-
mation This includes:

 

– Temperature resistance up to 138°C

 

– Standards DIN EN ISO 11607-1/2

 

– The applicable sections of the standard series 

DIN EN 868

The sterile barrier system must be large enough 
Once it is loaded, the sterile barrier system must 
not be under any strain

13.10  Steam sterilising

WARNING
Health risk due to incorrect sterilisa-
tion

If the sterilisation not performed correct-
ly, it may not be effective The use of in-
struments that have not been properly 
sterilised can pose a health risk to the 
patient

 

i

Only steam sterilisation must be used

 

i

Comply with all of the specified proc-
ess parameters

 

i

Comply with the manufacturer‘s in-
structions regarding use of the steam 
steriliser

 

i

Do not use any other methods

NOTICE
Damage to equipment due to incor-
rect sterilisation

If the sterilisation process is not per-
formed correctly, this can cause dam-
age to the product

 

i

Comply with the manufacturer‘s in-
structions regarding use of the steam 
steriliser

 

i

Comply with all of the specified proc-
ess parameters

EN

Содержание Vector Scaler

Страница 1: ...EN 1808V002 9000 615 32 02 0297 Installation and operating instructions Vector Scaler ...

Страница 2: ......

Страница 3: ...outside surfaces 26 12 2 Activating the cleaning process of the device 26 12 3 Cleaning the fluid container 28 12 4 Cleaning the sleeve part and adapter of the handpiece hose 28 EN Contents Important information 1 About this document 3 1 1 Warnings and symbols 3 1 2 Copyright information 4 2 Safety 4 2 1 Intended purpose 4 2 2 Intended use 4 2 3 Improper use 4 2 4 General safety information 5 2 5 ...

Страница 4: ...ate rinsing disinfection final rinse drying 35 13 8 Check for function 35 13 9 Packing 35 13 10 Steam sterilising 36 13 11 Issue clearance for the parts for sterilisation 36 13 12 Storing parts for sterilisation 36 14 Treatment breaks for more than 24 hours 37 14 1 Cleaning and disinfecting the hose system 37 14 2 Initial start up after a break in treatment for more than 24 hours 37 15 Maintenance...

Страница 5: ...it If the instructions and information in these installation and operating instruc tions are not followed Dürr Dental will not be able to offer any warranty or as sume any liability for the safe operation and the safe functioning of the unit 1 1 Warnings and symbols Warnings The warnings in this document are intended to draw your attention to possible risks of personal injury or material damage Th...

Страница 6: ...d for use in peri odontology for the removal of plaque and for the cleaning of tooth surfaces This is done via cavitation polishing grinding and scraping Fur ther assistance for the treatment can be provid ed by using hydroxyl and or fluorapatite as a polishing agent in periodontology Only agents approved by the manufacturer may be used The treatment is gentle on the teeth and almost painless 2 3 ...

Страница 7: ... from the use of non origi nal wear parts or replacement parts The use of non approved accessories optional accessories or non genuine wear parts replacement parts e g mains cable can have a negative effect in terms of electrical safety and EMC 2 4 General safety information WARNING Contraindication Ultrasound vibrations can interfere with the function of heart pacemakers and defibrillators i i Pa...

Страница 8: ...en 2 9 Disposal Unit The unit must be disposed of properly Within the European Union the unit must be disposed of in accordance with EU Directive 2012 19 EU WEEE i i 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 i i Decontaminate...

Страница 9: ...er 2a Valve 3 Cover for fluid container 4 Mains cable 5 Flexible foot switch cable 6 Scaler handpiece 6a Handpiece 6b Light conductor 6c Cover 7 Handpiece hose 8 Tool kit Scaler P1 P4 9 Scaler steri box 10 Whetstone 11 Vector toolcard 12 Rinsing adapter for scaler instruments 13 Rinsing adapter for handpieces yellow 14 Flexible foot switch Product description EN ...

Страница 10: ...o country spe cific requirements and or import regulations Vector scaler 2032 50 Unit base Scaler handpiece Scaler instrument P1 Power supply unit Flexible foot switch including cable Battery for flexible footswitch 3 V Lithium CR 2032 Scaler steri box Whetstone Combination wrench Vector toolcard Vector cleaner special cleaner Vector RinsEndo disinfection first application 120 ml Vector Scaler Ins...

Страница 11: ...Medical device Class IIa 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 2 Scaler handpiece g approx 56 Dimensions W x H x D Basic unit cm 21 5 x 25 2 x 16 Scaler handpiece cm Ø 2 0 x 9 4 Battery for flexible foot switch Voltage V 3 Type Lithium CR2032 Ambient conditions duri...

Страница 12: ...tage fluctuations flickers in acc with IEC 61000 3 3 Not applicable Electromagnetic compatibility EMC Interference immunity tests Static electricity discharge in accordance with IEC 61000 4 2 Compliant Magnetic field for a supply frequency 50 60 Hz in ac cordance with IEC 61000 4 8 Compliant Emitted HF disturbance variables in accordance with IEC 61000 4 3 Compliant EN ...

Страница 13: ... after the end of the service life The ID number is made up of the following marking MMXXXX MM Date of manufacture year and month XXXX Consecutive alphanumerical ID number Scaler tool kit 4 4 Evaluation of conformity This device has been subjected to conformity acceptance testing in accordance with the cur rent relevant European Union guidelines This equipment conforms to all relevant require ment...

Страница 14: ... via the operating panel 6 LEDs are integrated 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 ...

Страница 15: ...e power supply unit The supply voltage of the power supply unit matches the data on the type plate i i Plug in the connecting plug of the connecting cable into the connecting socket of the unit i i Fit the correct country specific adapter i i Plug the mains plug into the power outlet 6 Requirements The room chosen for installation must satisfy the following requirements Closed dry room Clean level...

Страница 16: ...vice is al ways used i i Make sure they are stored together as well Performing pairing Place the flexible foot switch ready Insert a battery in the flexible foot switch 15 4 Inserting or changing the battery in the flexible foot switch Disconnect the foot pedal cable from the unit and foot switch if previously connected Before carrying out the pairing process make sure that no other Vector device ...

Страница 17: ...ot switch for around 3 sec onds until the orange PEDAL LED goes out Result After successful pairing the unit is immediately ready for operation If nothing happens when the flexible foot switch is operated it is possible that the foot switch being used is paired with a different device In this case cancel the pairing and repeat the process Cancelling a pairing Requirements No foot switch cable must...

Страница 18: ...ht conductor is located under the front cover As soon as the flexible foot switch is operated 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 The LEDs are actuated individually so that if one LED stops working the light source remains lit 9 Components 9 1 Scaler handpiece Overview The Vector Scaler handpiece...

Страница 19: ...s Scaler tool kit P4 120 µm for supragingival removal of coatings on smooth surfaces and for interdental areas Disassembly i i Dismantle the instrument i i Pull off the hose connection from the hand piece i i Unscrew the front cover from the handpiece working anti clockwise i i Disconnect the light conductor Assembly i i Connect the light conductor i i Screw the front cover onto the handpiece work...

Страница 20: ... can be connected with a ca ble to the unit so that the treatment can be con tinued The battery can then be inserted later on Changing the battery 15 4 Inserting or chang ing the battery in the flexible foot switch 9 5 Fluid container The fluid container can hold up to approx 600 ml of water or water based fluids 9 3 Steri box Scaler steri box cover blue All parts which can be sterilised are optim...

Страница 21: ...at ments additional active ingredients can be add ed to the water Possible active ingredients include e g chlo rhexidine digluconate solutions up to a total concentration of 0 2 other solutions may damage the system and can lead to unsuccess ful treatment i i After using a water based active ingredient the unit should be thoroughly rinsed using warm water 9 6 Cleaning components Vector RinsEndo Di...

Страница 22: ... minute 16 PEDAL flexible foot switch LED on low battery power change the battery of the flexible foot switch LED flashing no flexible foot switch connected cable operation or as signed wireless operation 17 FUNCTION LED lights up The operation has been interrupted Clean the instru ment chuck with the air and water syringe and dry it then continue the treatment 10 Operation 10 1 Display handling S...

Страница 23: ... 30 2 approx 37 3 approx 45 RINSE After every treatment the system must be rinsed with water The rinsing process is started by touching the RINSE button it ends automatically after ap prox 30 seconds If a rinsing process is running it can be interrupt ed at any time by touching the RINSE button LED flashing the vibration behaviour of the instrument is impaired Contact pressure of the instru ment i...

Страница 24: ...D on the operating panel lights up to show that cleaning needs to be performed The blue LED goes out when the cleaning proc ess is completely finished If the cleaning process is not properly complet ed the blue LED will light up every time the unit is switched on PEDAL flexible foot switch Operating the flexible foot switch will activate the handpiece If the orange LED lights up the battery power ...

Страница 25: ... kit cover of the instrument is used as a torque wrench for tightening the union nut of the instrument chuck i i 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 i i Always use the torque wrench to screw the in strument on and off When screwin...

Страница 26: ...11 1 Preparation Perform the following steps before every treat ment i i Make sure that only handpieces and instru ments are used that have been reprocessed since the last treatment i i Check that the instrument is correctly seated and in perfect condition see Inserting chang ing instruments on page 23 i i Check the fill level of the fluid container i i Adjust the power on the operating panel as r...

Страница 27: ...tantly in motion in the longitudinal direction of the tooth or trans versely across the approximal surface lingually or buccally away from the tooth i i Guide the instrument with minimal pressure in such a way that the movements of the tip are always parallel to the tooth surface i i Make sure that only the side surfaces of the instruments are used Never use the front or rear surface of the instru...

Страница 28: ...l FD 366 sensitive rapid surface disinfectant NOTICE Liquid can cause damage to the unit i i Do not spray the unit with cleaning and disinfectant agents i i Make sure that liquid does not get in side the unit i i For pre cleaning remove coarse organic soil ing with a paper towel i i Clean the surfaces with a moist soft lint free cloth Scaler instrument P4 120 mm for the removal of supragingival co...

Страница 29: ... cleaning agent could cause irritation in the patient i i Top up the fluid container to the upper mark ing with water 12 2 Activating the cleaning process of the device We recommend that cleaning is per formed every 4 weeks The cleaning process can be started at any time as re quired After approx 30 operating the CLEAN LED will light up on the operating panel to show that cleaning is required A cl...

Страница 30: ...RINSE rinsing disinfecting button for at least 2 seconds LED RINSE flashes RINSE The device is rinsed with water for 30 sec onds The process ends automatically After the end of the complete cleaning proc ess CLEAN RINSE the CLEAN LED goes out again and an acoustic signal sounds 3x high pitched audible signal If the cleaning process is not performed in full or it is stopped prematurely then the blu...

Страница 31: ...zymatic instrument cleaner Dürr Dental Cleaning brush Manual disinfection ID 213 Instrument disinfection Dürr Dental Automatic cleaning and disinfection Was performed in accordance with EN ISO 15883 with tested efficacy Cleaning agent Neodisher MediClean Forte Washer disinfector PG 8535 Miele Programmes Cleaning without neutralisa tion and THERMAL DES Rinsing adapter Miele 68551101 D Cleaning brus...

Страница 32: ...rush heads 2 Brush material nylon Brush head length 25 and 35 mm Brush length 5 and 10 mm Example Interlock cleaning brush double sided green REF 09098 General information NOTICE Equipment damage due to unsuitable products Oils and care products containing oil will damage the device i i The handpiece must not be main tained with oil or with a care system that contains oil i i Comply with all natio...

Страница 33: ...of the handpiece Scaler cover light conductor instrument holders of the tool kits without instruments and the disassembled handpiece in the clean ing bath for the required reaction time so that all parts are covered i i Clean all accessible external surfaces and in ternal surfaces below the surface for 5 min utes with a sterile cleaning brush until all visi ble contaminants have been removed Rinsi...

Страница 34: ...een removed i i Place instruments in small parts baskets into the cleaning bath i i Rinse handpiece through at least 3 times using a 20 ml disposable syringe 20 ml i i Place instruments in small parts baskets into the cleaning bath i i Rinse handpiece through at least 3 times using a 20 ml disposable syringe 20 ml i i Screw Scaler instruments onto the rinsing adapter one after another and rinse th...

Страница 35: ...uments at least 3 times using a 20 ml disposable syringe 20 ml i i Remove all rinse adapters i i Comply with the cleaning agents action times specified by the manufacturer Final rinse After the action time prescribed by the manufac turer i i Rinse all components under running water for at least 1 minute temperature 20 C Drying i i If necessary re dry at a clean location using a hygienic lint free ...

Страница 36: ... one after another and rinse through each of the instruments at least 3 times using a 20 ml disposable syringe 20 ml i i Comply with the cleaning agents action times specified by the manufacturer Intermediate rinsing After the action time prescribed by the manufac turer i i Rinse all components under running water for at least 1 minute temperature 20 C i i Rinse handpiece through at least 3 times ...

Страница 37: ... of the instruments at least 3 times using a 20 ml disposable syringe 20 ml i i Comply with the cleaning agents action times specified by the manufacturer Final rinse After the action time prescribed by the manufac turer i i Rinse all components under running water for at least 1 minute temperature 20 C Drying i i If necessary re dry at a clean location using a hygienic lint free cloth i i Blow dr...

Страница 38: ... sterile barrier system should be taken into account in terms of aseptic preparation when estab lishing the storage conditions 13 9 Packing CAUTION Endangering the sterilisation success The fitted components are not reached by the steam and as such are not steri lised i i Do not fit the components before packaging For packaging of the components use only sterile barrier systems made of transparent...

Страница 39: ...in the hoses and any irritation to the patient caused by the taste of residual disinfectant will be avoided i i Pull off the hose connection from the hand piece i i Lay the handpiece hose in the sink i i Fill the fluid container with water i i Touch the RINSE rinsing disinfecting button for at least 2 seconds LED flashes the rinsing process takes around 30 seconds and ends automatically 14 Treatme...

Страница 40: ...i clockwise i i Clean the valve If cleaning is not possible e g if the filter in the valve is blocked then the valve needs to be replaced i i Check the O ring In the event of leaks loose seating or visible damage the O ring must be replaced i i Insert the valve in the holder and tighten it clockwise as far as it will go 2 Decontamination process was not carried out before surgery break i i Perform...

Страница 41: ...take on a milky colour light transmission begins to decrease i i Unscrew the cover i i Disconnect the light conductor i i Connect a new light conductor i i Screw on the cover 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 th...

Страница 42: ...the cover 15 4 Inserting or changing the battery in the flexible foot switch A new battery should be inserted in the flexible foot switch prior to initial start up in wireless op eration or if the power of the existing battery is low Opening the cover i i Press both pins on the flexible foot switch to gether at the same time and lift the cover off Checking the battery i i Press the button to the l...

Страница 43: ...e The battery in the flexible foot switch is empty i i Check battery performance and insert a new battery if neces sary Interference caused by external wireless signals i i Operate the flexible foot switch using the foot switch cable The wireless module in the flexible foot switch is defective i i Operate the flexible foot switch using the foot switch cable or call a Service Technician The wireles...

Страница 44: ... hose leaks i i Pull off the handpiece from the handpiece hose i i Replacing the sealing screw Fluid leaks out between Scaler handpiece and instrument Scaler instrument was not screwed on with the full torque i i Screw on the Scaler instrument correctly Scaler instrument has become loose i i Screw the Scaler instrument in place correctly i i If there are signs of wear re place the instrument Fluid...

Страница 45: ... LED flashes No flexible foot switch connected cable operation or paired wire less operation i i Connect a flexible foot switch cable operation or perform pairing wireless operation Blue CLEAN LED con tinues to light up after a cleaning program has been carried out The CLEAN function of the clean ing process was not fully com pleted or it was stopped early i i Carry out the cleaning process CLEAN ...

Страница 46: ......

Страница 47: ......

Страница 48: ...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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