KaVo HealOzone 2130 C Instructions For Use Manual Download Page 15

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Instructions for use HealOzone 2130 C
2 Safety

2.2 Intended purpose

2.2.3 Product-specific

CAUTION

Risks from electromagnetic fields.

The functions of implanted systems (such as pacemakers) can be influenced by

electromagnetic fields.

▶ Ask patients before treatment.

HealOzone is intended for the treatment of tooth substance. HealOzone treatment

disables bacteria on teeth, inside dentine and in the root canal.

Indications:

▪ Fissure caries

▪ Root caries, smooth caries, hypersensitive cervical areas

▪ Open, carious lesions in connection with additional conservative measures

▪ Prophylactic measures for fissures and smooth surfaces

▪ Endodontic treatments

See also: Application manual for Healozone.

For up-to-date information about research and clinical use, please visit

www.kavo.com.

Note

According to the EC Directive 2002/96 concerning electrical and electronic used

devices, this product is subject to the cited directive and must be disposed accor‐

dingly within Europe.

Before disassembling and disposing of the product, it must be completely proces‐

sed (disinfected, sterilised) according to the section "Preparation methods".

Additional information can be obtained from KaVo (www.kavo.com) or your dental

supplier.

Electromagnetic compatibility

Note

Based on EN 60601-1-2:2001 concerning the electromagnetic compatibility of

electromedical devices, we need to point out that:

• Medical electrical devices are subject to special measures regarding electroma‐

gnetic compatibility and must be operated in accordance with KaVo assembly

instructions.

• Portable and mobile high-frequency communications devices can influence me‐

dical electronics.

• More information on the technical description of EMC can be obtained upon re‐

quest.

13/57

Summary of Contents for HealOzone 2130 C

Page 1: ...Instructions for use HealOzone 2130 C Always be on the safe side ...

Page 2: ...Sales KaVo Dental GmbH Bismarckring 39 D 88400 Biberach Tel 49 7351 56 0 Fax 49 7351 56 1488 Manufacturer Kaltenbach Voigt GmbH Bismarckring 39 D 88400 Biberach www kavo com ...

Page 3: ...nsmissions 9 2 2 2 General 12 2 2 3 Product specific 13 2 3 Safety instructions 15 2 3 1 Product specific 15 3 Product description 16 3 1 HealOzone 2130 C 16 3 2 Straight handpiece 2131 C plus 17 3 3 Rating plate 18 3 4 Technical data 19 3 5 Purpose and Applications 21 3 5 1 pH balancer 22 3 5 2 Patient Kit 22 4 Commissioning 23 4 1 Preparations 23 4 1 1 Install air dryer 23 4 1 2 Install moisture...

Page 4: ...ean tubing 41 6 2 Disinfection 42 6 2 1 Unit disinfection 42 6 2 2 Handpiece disinfection 42 6 2 3 Tubing disinfection 43 6 3 Sterilisation 44 6 3 1 Handpiece sterilisation 44 6 3 2 Tubing sterilisation 44 7 Maintenance 45 7 1 Care and maintenance 45 7 1 1 Handpiece care and maintenance 45 7 1 2 Tubing care and maintenance 45 7 2 Maintenance 46 7 2 1 Replace O ring 46 7 2 2 Sensor counter mode 47 ...

Page 5: ...0 C 1 User notes 1 1 Service 1 User notes 1 1 Service Service hotline 49 0 7351 56 2500 Service Einrichtungen kavo com Please indicate the product serial number in all requests Additional information can be obtained at www kavo com 3 57 ...

Page 6: ...event misuse and damage 1 2 1 Abbreviations Short form Explanation GA Instructions for use PA Care instructions MA Assembly instructions TA Technician s instructions STK Safety check IEC International Electrotechnical Commission RA Repair instructions EMC Electromagnetic compatibility 1 2 2 Target group This document is for dentists and office personnel 4 57 ...

Page 7: ...ly only if there are no compelling legal regulations to the contrary KaVo is not liable for defects and their consequences that arise from natural wear improper cleaning or servicing the non observance of instructions for use servicing or connection scale formation or corrosion impurities in the air and water supply or chemical or electrical influences that are unusual or impermissible according t...

Page 8: ...ide of Germany Note KaVo is not liable for damage arising from transportation Immediately inspect the delivery after receipt If external damage to the packaging is visible upon delivery follow the procedure below 1 The recipient must record the loss or damage in the notice of delivery The re cipient and employee of the transportation firm must sign the notice of delivery The recipient can only ass...

Page 9: ...g for returning the product for service or repairs The symbols printed on the outside are for transportation and storage and have the following meaning Transport upright with the arrows pointing upwards Fragile protect against knocks Keep dry Maximum permitted stacking load Temperature range Humidity Air pressure 7 57 ...

Page 10: ...optional step contains necessary measures for avoiding hazards 2 1 3 Description of hazardous steps Safety instructions with three hazard levels are used in this document for avoiding personal and property damage CAUTION CAUTION indicates a hazardous situation that can lead to property damage or minor to mo derate injury WARNING WARNING indicates a hazardous situation that can lead to serious inju...

Page 11: ...ccording to CISPR 11 Group 1 The HealOzone 2130 C uses HF energy only for its internal operati on Its HF transmission is therefore very low and it is improbable that neighbouring electronic devices will be disturbed HF transmissions according to CISPR 11 Class B Die HealOzone 2130 C is for use in all facilities included residential ones and facilities that are directly connected to a public power ...

Page 12: ... kV push pull voltage 2 kV common mode volta ge The quality of the supply voltage should correspond to that of a typical business or hospital environment Voltage interruptions short term interruptions and fluctuations of the supply voltage according to IEC 61000 4 11 5 V 95 drop in the VT for period 40 V 60 drop in the VT for 5 periods 70 V 30 drop in the VT for 25 periods 5 V 95 drop in the VT fo...

Page 13: ...uency bands for industrial scientific and medical applications bet ween 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHZ to 27 283 MHz and 40 66 MHz to 40 70 MHz b The conformance levels in the ISM frequency bands between 150 kHz and 80 MHz and the frequency range of 80 MHz and 2 5 GHz are intended to reduce the pro bability that mobile and portable communications ...

Page 14: ...applicable accident prevention regulations Apply and meet the overarching guidelines and or national laws national regulati ons and the rules of technology for medical devices applicable for startup and use of the KaVo product for the intended purpose Note The waste that arises must be recycled or disposed of in a manner safe for humans and the environment Observe the applicable national regulatio...

Page 15: ...sit www kavo com Note According to the EC Directive 2002 96 concerning electrical and electronic used devices this product is subject to the cited directive and must be disposed accor dingly within Europe Before disassembling and disposing of the product it must be completely proces sed disinfected sterilised according to the section Preparation methods Additional information can be obtained from ...

Page 16: ...l components can increase transmission or reduce the electromagnetic immu nity of the product Only use accessories recommended by KaVo Note KaVo cannot guarantee that accessories lines and transformers not delivered by KaVo will correspond with EMC requirements of EN 60601 1 2 2001 Contraindications The treatment of open wounds in soft tissue with exposed pulp has not been clini cally investigated...

Page 17: ... when the housing is not damaged Proper maintenance and servicing of the HealOzone unit will ensure that the respi ratory tracts are not exposed to ozone Proper use of the unit will ensure that neither the dentist nor the patient is exposed to an excessive concentration of ozone If a strong ozone smell arises from the device the treatment must be stopped im mediately and the device must be checked...

Page 18: ... 2 3 4 5 HealOzone unit Mat no 1 000 0100 Instrument tubing Mat no 1 002 7070 Straight handpiece 2131 C plus Mat no 1 002 5320 Mains cable country specific Footswitch Mat no 1 000 2356 Note Starting with software version 3 10 the KaVo HealOzone can be used for endo dontic treatment See also 5 2 1 Start sequence Page 33 16 57 ...

Page 19: ...Instructions for use HealOzone 2130 C 3 Product description 3 2 Straight handpiece 2131 C plus 3 2 Straight handpiece 2131 C plus 2 1 Handpiece Endodontics cannula 17 57 ...

Page 20: ...ve accompanying documents and safety instructions Application part type B Nemko mark of conformity Mode exposure mode Operating time 3 minutes Pause time 7 minutes Fuse rated value 30VA Degree of protection IP 20 115V 100 120V 50 60Hz 230V 230V 50 60Hz Device supply voltages REF 1 000 0100 Mat number SN XXXXXX Serial number Type 2130 C Device type Date of manufacture 18 57 ...

Page 21: ...100 120 V 230 V Power rating 30 VA Frequency 50 60 Hz Ambient conditions during treatment Permissible for interior use Ambient temperature range 10 40 C Max relative humidity 80 Operating mode Operating time 3 min Interval 7 min Classification Protection class I Application part Type B Protection category IP 20 Fuse Rated voltage 250 V Rated current 0 63 A Trigger characteristics T Breaking capaci...

Page 22: ...nstructions for use HealOzone 2130 C 3 Product description 3 4 Technical data Transportation and storage conditions Temperature min 30 max 80 Humidity min 5 max 95 Air pressure min 700 max 1060 hPa 20 57 ...

Page 23: ...ferential pressure sensor Hose Air dryer cartridge Handpiece Vacuum pump Silicone cap Ozone neutraliser The HealOzone treatment system is a medical electronic device It consists of an ozone generator and a handpiece with a disposable sealing cap that is connected via an instrument hose to the device It was developed to apply ozone via the handpiece to the surface of the carious tooth to treat the ...

Page 24: ...ts the ozone into oxygen A liquid pH balancer is subsequently applied 3 5 1 pH balancer Cut off the tip of the pH balancer ampoule Mat no 1 002 3718 apply a few drops on the site treated with ozone and then let it act for 10 seconds The pH balancer contains citric acid for conditioning the surface and creating the optimum pH This prepares the surface for applying the fluoride that is another ingre...

Page 25: ...create ozone Desiccant is used to dry the ambient intake air An air dryer is supplied with the system as standard Note Desiccant is available from dental suppliers Remove stopper from the air dryer and dispose of it Note The arrow must be pointing in the direction of flow towards air dryer Pour the supplied desiccant into the air drier See also 7 2 3 Replace desiccant Page 48 Snap air dryer into h...

Page 26: ...system vacuum into the handpiece The prevents the ozone neutraliser from soiling Note Ten moisture traps are supplied with the system as standard Extra moisture traps are available from dental suppliers Remove moisture trap from packaging and fasten the screw cap on the end of the tubing onto the thread marked Fit the other tubing end on the connection piece marked 1 2 24 57 ...

Page 27: ... with a quick coupling Note The coupling at the end of the tubing is identical and can be connected in both directions Make sure there is an O ring on the coupling and that it is undamaged Grease the coupling O ring with silicone grease Mat no 1 000 6403 Fit handpiece onto coupling making sure that it snaps in place Give the handpiece a gentle tug to check it is securely in place 25 57 ...

Page 28: ...2 Connect the instrument tubing to the unit Note Make sure there is an O ring on the coupling and that it is undamaged Push the tubing connector into the quick coupling of the console until it snaps in place Give the tubing a gentle tug to check it is securely in place 26 57 ...

Page 29: ...ning 4 2 Connections 4 2 3 Attach silicone cup Note The silicone cap must be seated precisely in the groove to provide the seal required for treatment Before commencing treatment fit the silicone cap over the groove on the head of the handpiece 27 57 ...

Page 30: ...Ozone 2130 C 4 Commissioning 4 2 Connections 4 2 4 Connect footswitch Note The footswitch is optional The unit can be operated without it Insert the footswitch flex into the plug fit connection on the reverse of the unit 28 57 ...

Page 31: ...tor are 115 V and 230 V The device is set in the factory to a mains voltage of 230 VAC 50 60 Hz Check this setting and change it to the existing supply voltage if necessary Plug in inlet connector at the reverse of the HealOzone unit Plug end of cable into a socket Note The socket outlet must be properly grounded and meet the respective national guidelines For North America a hospital grade socket...

Page 32: ...Instructions for use HealOzone 2130 C 4 Commissioning 4 2 Connections 4 2 6 Service interface Use of the service interface is permitted for KaVo trained personnel only 1 30 57 ...

Page 33: ... start has been triggered the pump is turned on In this state the system waits until the flow sensor is active i e until the air circuit is closed and the actual treatment can start If a seal cannot be established the process is terminated after a set period A warning is emitted The warning can be acknowledged by pressing any button or the footswitch so that the system can be restarted If a closed...

Page 34: ...splay and reported acoustically with a double buzzer tone If ozone cannot be generated within 60 seconds the warning Ozone generation not successful is output The message can be acknowledged with any button and the treatment process can be restarted If the ozone is successfully generated treatment is started The treatment time is counted backwards in se conds and shown on the display A buzzer soun...

Page 35: ...monitoring C counter monitoring 5 2 2 Main menu The treatment time can be changed in incremental steps within the set thresholds using the plus or minus button Increments 10 seconds Minimum 20 seconds Maximum 60 seconds To start treatment press the Start button or the footswitch Screen information Treatment time Ready to start 5 2 3 Choose operating mode In the main menu press the Set button Opera...

Page 36: ... 5 2 6 Treatment start The treatment process has been activated The unit waits until a vacuum has been created The Seal cup line starts flashing You can press the stop button or the footswitch to stop the process Treatment time can be changed at any point up to the start of treatment If an airtight seal is not created within 60 seconds treatment is cancelled A warning message appears on screen Scr...

Page 37: ...s directly to rinse mode Screen information Remaining treatment time Ozone application 5 2 9 Ozone generation If it takes a while to generate ozone Generate ozone is shown on the display and reported acoustically with a double buzzer tone Screen information Treatment time Ozone is being generated Once the ozone starts being generated the device switches immediately to treat ment status If ozone ca...

Page 38: ...menu Screen information Treatment stopped Please repeat 5 2 12 Rinse When ozone production has come to an end or when treatment is cancelled by pressing the stop button or footswitch the unit switches directly to rinse mode Air is sprayed through the ozone ducts for a period of 10 seconds in order to clear them Screen information Remaining rinsing time Rinsing 5 2 13 End of treatment Following suc...

Page 39: ...cone cup onto the handpiece head See also 4 2 3 Attach silicone cup Page 27 After the root canal has been conventionally prepared you can continue treatment with the KaVo HealOzone A sterile cannula is inserted into the root canal The cannula is made of a very flexible and yielding material so that it can follow the course of the root canal The cannula penetrates as far as possible toward the apex...

Page 40: ...0 1 Removal of surface caries with a round burr 2 Disinfection in the zone of bacteria with the HealOzone no cannula 40 seconds 3 Complete removal of caries with a round burr and cleaning with PROPHYflex and PROPHYpearls 4 Extripation rinsing NaOCl 3 5 Electrical measurement of length and x ray measurement forensics 6 Preparation mechanical manual for example with ProTaperm ProFile RaCe EDTA 17 lu...

Page 41: ...s essential for any spilled substances to be wiped away immediately using a damp cloth The following cleansers may not be used Strongly alkaline washing solutions Acids Ammonia containing cleaning agents Abrasives of any kind Solvents on plastic parts CAUTION Damage from liquids Malfunctions of electrical components Cover openings in the product to prevent the penetration of liquids Remove liquids...

Page 42: ...g of the exterior Clean the exterior of the product by brushing it off under flowing water until there is no more visible soiling Interior cleaning by hand Connect up the handpiece and instrument tubing Place handpiece in a drip pan or basin Fit adapter onto quick coupling and rinse for 15 seconds using a water gun with cold tap water or Attach a standard 50ml infusion syringe and perform ten 50ml...

Page 43: ... malfunction Disinfect tubing before cleaning Disinfect again after cleaning if necessary Manual cleaning of the exterior Clean the exterior of the product by brushing it off under flowing water until there is no more visible soiling Interior cleaning by hand Connect up the handpiece and instrument tubing Place handpiece in a drip pan or basin Fit adapter onto quick coupling and rinse for 15 secon...

Page 44: ... corresponding to manufacturer s instructions for use such as with KaVo ELASTOclean 2 or Ecolab Incidin Liquid Interior disinfection by hand Connect the handpiece and instrument sleeve or Place the adapter on the quick coupling and rinse for 5 seconds with Spiriclens Ecolab or 3 times with 70 isopropanol 0 2 µm sterile filtered from the infu sion syringe or Fill with Ecolab Sekusept Plus 0 5 and l...

Page 45: ...eaning units Manual external disinfection Clean the exterior of the hose with chemical disinfectants wipe disinfection corresponding to manufacturer s instructions for use such as with KaVo ELAS TOclean 2 or Ecolab Incidin Liquid Mechanical external disinfection Using a Miele thermodisinfector for instance Use in accordance with manufacturer s user instructions Dry immediately afterwards to ensure...

Page 46: ...ilise the product in vapour permeable paper or material Stericlav bag KaVo Triple prevacuum at least 3 min 134 1ºC Gravity at least 10 min 134 1ºC Gravity at least 60 min 121 1ºC Drying time 10 min Spray the endodontics cannula an O ring after sterilisation with KaVo spray Mat no 0 411 9630 6 3 2 Tubing sterilisation CAUTION Damage caused by improper sterilisation Danger from contact corrosion Rem...

Page 47: ...are and maintenance 7 1 1 Handpiece care and maintenance Clear the air duct using compressed air then wipe Detach the handpiece from the instrument tubing and grease the coupling O rings with silicone grease 7 1 2 Tubing care and maintenance Clear the air duct using compressed air then wipe 45 57 ...

Page 48: ...Instructions for use HealOzone 2130 C 7 Maintenance 7 2 Maintenance 7 2 Maintenance 7 2 1 Replace O ring Using a probe replace the O ring 46 57 ...

Page 49: ...treatments 1000 treatments are programmed If one of the programmed values is exceeded the warning message Desiccant used up appears With this setting the user can be sure that the device is fully functional without exchanging the desiccant too early After the maximum operating hours or treatments are reached the warning mes sage Desiccant used up appears Change desiccant See also 7 2 3 Replace des...

Page 50: ...has been changed Pull the end of the tubing out of the lower connection piece and remove the air dryer Remove stopper from the air dryer Take out the used desiccant and dispose of in accordance with local and national waste disposal regulations Place funnel over air dryer and pour in the new desiccant to fill the air dryer Seal the air drier with a plug and snap it into the holder Fit the end of t...

Page 51: ...th an 10 moisture traps Additional moisture traps can be ob tained from the authorised dealer Pull the end of the hose off of the connector Unfasten the screw cap on the other end tubing end from the thread Dispose of the moisture trap in accordance with local and national regulations governing the disposal of contaminated waste Remove new moisture trap from packaging and fasten the screw cap on t...

Page 52: ...e exposure The ozone neutraliser is exchanged at each service interval A warning is generated for premature consumption The device needs to be sent in for servicing 7 2 6 Service intervals The unit must be sent away once a year for servicing Service Technicians are re quired to record all servicing activities on a servicing record located on the interior of the door Safety checks SFC are completed...

Page 53: ...ed up Threshold almost reached Continue with button After switching on self test Average humidity is the 7 thres hold that was set Desiccant is used up Change desiccant Continue with any button See also 7 2 3 Replace desiccant Page 48 Counter mode Warning 3 Desiccant used up Please replace Press SET After switching on self test Counter shows that the program med threshold of 600 hours opera ting t...

Page 54: ...pears after the next use See also 7 2 2 Sensor counter mo de Page 47 Desiccant is not connected Check whether desiccant is connected Sensor mode Warning 7 Desiccant used up Please replace Continue with button After the current treatment Average humidity is the 7 thres hold that was set Desiccant is used up Confirm the change of desiccant with the SET button or Continue with any button Counter mode...

Page 55: ...eck Sum CS program code er ror Inform technical service 09 ERROR_DATA Data error in SRAM Inform technical service 10 ERROR_FLUSS_MIN_ABGLEICH Flow sensor error minimum flow le vel not reached during calibration Inform technical service 11 ERROR_FLUSS_MAX_BETRIEB Flow sensor error maximum flow level exceeded during operation Inform technical service 12 ERROR_FLUSS_RICHTUNG Flow sensor error flow di...

Page 56: ...umption below minimum level Inform technical service 28 ERROR_LUEFTER_SW Ventilator switch function faulty Inform technical service 29 ERROR_LUEFTER_I_MAX Max ventilator power consumption level exceeded Inform technical service 30 ERROR_LUEFTER_I_MIN Ventilator power consumption be low minimum level Inform technical service 31 ERROR_EE_READ EEPROM data read error Inform technical service 32 ERROR_...

Page 57: ...edical device record in which you make an inventory listing and record the main master data of the medical device www kavo com De produkte praxis_einrichtungen The following readings and measurements must be documented Visual inspection of medical device and accessories Nominal data checks on externally accessible fuses Earthed conductor checks in accordance with VDE 0751 Leakage current measureme...

Page 58: ...1 Earth wire impedance measurement The following thresholds must not be exceeded 0 3 Ω with mains cable and 0 2 Ω without Using a test probe sample the rear panel of the casing 9 2 2 Replacement device leakage current measurement Must not fall below the 1 mA threshold L N MD 56 57 ...

Page 59: ...mm Mat no 1 002 1637 25 Silicone cap double length 4 mm Mat no 1 004 2053 25 Silicone cap double length 6 mm Mat no 1 004 2055 25 Silicone cap double length 8 mm Mat no 1 004 2056 1 Desiccant pearls Mat no 1 002 7782 1 Funnel Mat no 1 002 7184 10 Moisture trap Mat no 1 002 1638 6 Patient kit Mat no 1 002 1547 6 Cannulas with O rings long 20 mm Mat no 1 003 7388 6 Cannulas with O rings medium 13 mm...

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