Home

Instructions for use

1.
2. When the foot control is to be scrapped it must be disposed of if necessary as special electronic waste in accordance with local regulations 20 12 Characteristics Electrical Supply voltage 100 240 VAC Frequency 50 60 Hz Power 30 VA Fuse 2x 250V T1AH Operating mode Continuous Protection class Class II with functional earth connection Applied Part Type BF Degree of Safety in presence of a flammable anesthetic Not suitable Ozone Ozone production 140ppm 2L min Protection again ingress of water Prozone The control unit is classed as conventional equipment closed equipment without protection against the ingress of water Foot control IPX1 Drip Proof Physical Characteristics Weight 1 8 kg Dimensions 24 26 5 6 5 28 18 Electromagnetics compatibility Manufacturer s Declaration WARNING The use of accessories cables other than those specified may result in increased emission and or decreased immunity Cables Length Cables and accessories Handpiece cord Foot control Mains cord Maximum length 1 80 m 3 00 m 2 50 Complies with RF emissions CISPR 11 Class B Group 1 Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emission IEC 61000 3 3 Electrostatic discharge ESD IEC 61000 4 2 Electric fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations o
3. Instructions for use 2 3S3s ss O OZONE Symbols WARNING Risk of injury I Thermo washer disinfectable ATTENTION to prevent damage occurring 135 C Sterilizable up to the stated temperature e General explanations without risk to persons or objects Data Matrix Code for product identification e g in hygienic maintenance process Only for USA Caution Federal law restricts this device to sale by or on the order of a dentist physician or any other practitioner licensed by the law of the state in which he or she practices to use or order the use of the device Contents c0 NPP PP gt gt gt B B 4 5 zorie generatighi ie Eee 6 Equipment Supplied site 53 5022 t ee e eb EAE a dad e a dv hs Deseriptioniof front panel anao et Rad erectae de e RET ERROR 8 Description Of rear panel Ate ette ree i eti e ede eu te iei eapite e erai HRS 9 10 Description of Prozone handpiece with nennen tenente 11 DEScription Of Prozone marking teer tree eee 12 NSEICINUCIMT T 13 14 Starting Operation General eee 15 Starting Operation Control Unit 555 e Ere te erts 16 E 17 20 Disinfection Cleaning St
4. The filter is a key element for the generation of ozone The functions are gt Air drying gt Dust prevention Life time of the filter cartridge will depend on relative humidity conditions and number of treatments average 500 applications The top of the filter cartridge is fitted with a special indicator which will change colour with using yellow good for use blue yellow needs to be replaced blue expired error CF When Prozone is not use for more than 2 days place the black rubber cover over the filter cartridge Changing the filter gt For easy access to the filter remove the foot control connector gt Unscrew the used filter gt Install the new filter gt Reattach the foot control connector If the filter is not attached correctly error 1 will appear on the digital display when the Prozone is put into operation 22 Maintenance Checking the ozone concentration level W amp H recommends sending in the Prozone every 12 months for a safety inspection 23 14 Warnings Warnings only appear Standby Ready mode and never interrupt a treatment Activating any button will erase the warning display and the Prozone will return to Standby mode after a purge of the air circuit Display CF After every hour of ozone generator working time CF will be indicated on the display panel as a reminder to check the filter status Refer to Maintenance Filter section D
5. 42 EEC BA Follow operating instructions O ON and OFF positions marked Separate collection for electrical and electronic equipment waste per Directive 2002 96 EEC in the European Union Lx Equipment of Protective Class II BF appliance not suitable for intracardiac application Foot control connector Year of manufacture REF Catalog number SN Serial Number Fuse Functional Earth 10 6 Description of Prozone handpiece CE symbol refers to Directive 93 42 EEC Serial Number Sterilizable up to 135 C in autoclave Thermo washer disinfectable 11 Description of Prozone tip marking C CE symbol refers to Directive 93 42 EEC Q Single use Lot Batch number EC REP EC European Representative 12 8 Safety notes Please ensure that you carry out the following instructions before operating the unit gt Only operate the Prozone when you have high volume aspiration 50I min and at the point of application gt Never operate unit if any tubing is damaged or worn gt Use only original parts and accessories as recommended by the manufacturer The use of non original parts will invalidate any claims under warranty Inappropriate Use Improper use in addition to assembly installation modifications or repairs of the unit or non compliance with an instruction invalidates all claims under warranty and an
6. applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered if the measured field strength in the location in which the product is used exceeds the applicable RF compliance level above the product should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the product Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 34 Recommended Separations Distances The product is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the product can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the product as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to freq
7. in standby N Only use the Prozone with a yellow filter Humidity inside the ozone generator will reduce the production of ozone gt reduce the life time of the ceramic plate yellow good blue yellow to be exchanged blue expired error CF The device will display an error E2 when there is a low output of ozone In this case the Prozone will have to be re calibrated bu a TTT appointed distributor 3 Equipment supplied REF 12930100 Prozone unit Prozone handpiece tube with connector Prozone handpiece O Prozone filter cartridge Prozone foot control Prozone tips Coro 20 pcs Prozone tips Endo 20 pcs Prozone tips Perio 20 pcs O IFU 50631 Prozone Instruction for use Only one supplied REF 01343200 Mains cord EUR REF 03212200 Mains cord UK REF 04280600 Mains cord CH REF 02909300 Mains cord AUS 7 O REF 02821400 Mains cord USA REF 05901800 Mains cord DK A Handpiece and handpiece tube are not delivered sterile and therefore must be sterilized to prior first use 4 Description of front panel Ozone Generator monitor Time sec Program select Display Handpiece tube connector buttons 6 24 5 Description of rear panel Connecting socket for foot pedal Power switch Power socket Fuse holder Filter chamber ON OFF Description of rear panel C CE symbol refers to Directive 93
8. 5 10 Starting operation Control Unit Immediately after switching the unit ON a purge 30sec 90sec is automatically performed and all four programmes 6 24 will be illuminated by a blue LED accompanied by a single beeping sound Then the unit is Standby mode For all procedures please observe the following Press desired program select button The unit goes to Ready mode O Cycle button illuminated and flashing allowing user 30 seconds preparation time to place aspiration and Prozone tip Pressing the program select button return to Standby mode O Activate foot control briefly After a 3 second warmup 05 LED is ON indicating ozone generator is active Treatment Countdown Fast beeping Pressing program button will interrupt the treatment There is a system flush for 10 seconds at the end of each treatment Keep aspiration and Prozone tip in place until the fast beeping has been replaced by slow beeping Unit returns to Ready mode for 30 seconds during which time treatment may be continued by reactivating foot control After 30 seconds or pressing the program select button the unit return to Standby mode N Before treatment ensure high volume aspiration is used 7 50l min prior to activating foot control 16 11 Clinical applications N Please use high volume aspiration 50l min Place Prozone tip as close as possible to the treatment area 1 2mm A Apply only the prescr
9. act 8 kV air 2 kV for power supply lines 1 KV for input input output lines 1 kV differential mode 1 common mode Electromagnetic Environment Guidance Floor should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial and or hospital environment Mains power quality should be that of a typical commercial and or hospital environment 31 Electromagnetic Immunity Immunity Test Voltage dips short interruptions and voltage Variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 HZ magnetic field IEC 61000 4 8 60601 1 2 lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in for 5 cycles 70 Ur 30 dip in for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec 3 A m Compliance Level 5 gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 20 Ur 30 dip in Ur for 25 cycles 5 4 Ur gt 95 dip in Ur for 5 sec 3 A m Electromagnetic Environment Guidance Mains power quality should be that of a typical commercial or hospital environment If the user of the product requires continued operation during power mains interruptions it is recommended that the product be powered from an uninterruptible power supply Power freque
10. eclaration does not apply to non specified fittings mountings etc Introduction Responsibility of the manufacturer Tip Top Tips TTT can only accept responsibility for the safety reliability and performance of the Prozone when there is compliance with the following directions gt The Prozone must be used in accordance with these Instructions for use gt The Prozone has no components which can be repaired by the user Assembly modifications or repairs must only be undertaken by skilled personnel authorized by TTT gt The electrical installation at the premises must comply with the regulations of VE EN 7 Installation of electrical equipment in rooms used for medical purposes or with the regulations applicable in your country Unauthorized opening of the Prozone invalidate all claims under warranty and any other claims 2 Ozone generation Generation of ozone is created with a high voltage applied on a ceramic plate principle called corona discharge To produce ozone with the Corona effect it is very important that the air inside the ozone generator chamber is dry The device will purge for 30 secs each time it is turned on up to 90 sec if the air flow is reduced for example with an Prozone tip Endo connected This purge will ensure that the humidity that could remain in the Prozone while the device is not in use will be evacuated The purge can also be performed manually by depressing the 05 button while the device is
11. ect Complete obturation procedure Should bleeding from the pulp chamber occur utilize ozone gas to coagulate bleeding V M M M VM 19 Clinical applications Which tips to use Prozone tips are specifically designed and manufactured for use with the Prozone We suggest you use the following tips for each specific treatment Prozone tip Coro general use cavity preparation surgical disinfection etc Prozone tip Endo endodontics needle tip for endodontics Prozone tip Perio fine capillary tip for periodontal pockets 20 12 Disinfection Cleaning Sterilization Wear protective gloves Disinfect and clean the handpiece immediately after every treatment Control unit foot control The front panel of the control unit is sealed and may be wiped clean Disinfect using surface disinfectants Use certified surface disinfectants e g DGHM tested Handpiece Handpiece tube Wrap handpiece in sterilization bag according to EN 868 5 TTT recommends sterilization according to EN 13060 class B Vacuum sterilization Steam vacuum sterilization according to EN 13060 using a sterilization holding time of a minimum of 3 minutes at 134 3 C 273 2 5 4 F Gravity sterilization Steam gravity sterilization using a sterilization holding time of a minimum of 4 minutes at 134 3 C 273 2 5 4 F Before starting operation again wait until the handpiece is completely dru 21 13 Maintenance Filter Cartridge
12. ed out by third parties not authorized to do so by TTT Parts subject to normal wear such as bulbs are excluded from the warranty Claims under warranty accompanied by proof of purchase must be sent to the vendor or to an authorized TTT service point The provision of service under warranty extends neither the warranty period nor any other guarantee period 37 CERTIFICATION OF TRAINING Name of the customer user Adress Distributor p 4 Prozone Serial Number E The user customer have been trained in all functions of the unit in accordance with current Instructions for Use Particular attention was shown to Safety notes Disinfecting Cleaning Sterilization and Servicing ere Name of the instructor Address p l 4 L J c D gt e oa 5 D gt Prozone follow User Control Prozone Date Drager 10 a Visa OK Note 39 Distribution W amp H Dentalwerk B rmoos GmbH Ignaz Glaser Strafle 53 5111 B rmoos Austria 43 6274 6236 0 f 43 6274 6236 55 office wh com wh com Manufacturer TIP TOP TIPS Sarl Ch de la Navigation 4 Box 122 CH 1180 Rolle Switzerland C Form Nr 50631 AEN 41 21 801 20 00 f 41 21 826 20 01 1254 180 13485 Rev 00 09 06 2009 ttt ttt swiss com Subject to alterations
13. erilization seoesesoesssesessossesosesoncosessssesosossoseseesseesersoseseseososossssosesevsesoseeseseressesesesessesessesesesererssssess ssesse 21 Maintenant sissies M 22 23 3 A e e E UM T A LE Te TU 24 una EE 25 26 Environmental COMAItIONS E 22 CharacteristlCS anioia tr AEAN T ROTG UID 28 Electromagnetics Compatibility ronianer r a E entente tete nne 29 35 ACCESSOMIES AEAN EE E OE CE A he 36 3 1 Introduction For your safety and the safety of your patients These Instructions for Use explain how to use your product However we must also warn against possible hazardous situations Your safety the safety of your team and of course the safety of your patients are of paramount importance to us It is therefore essential to read the safety notes Intended use The Prozone is an electrical device which produces ozone for use in various dental applications Qualifications of the user The Prozone has been designed and developed for the dental profession Only suitably qualified medical technical and specialist staff may use the Prozone unit after specific training Production according to EU Directives EU Directive 93 42 EEC has been used as a basis in the design and manufacture of this medical product and this applies to the Prozone unit This d
14. ibed time of application Do not over ozonate tissues PROGRAM 6 seconds Cavity disinfection technique Prozone tip Coro Prepare cavity as per standard procedure Select 6 on display panel Follow steps 2 5 to disinfect cavity Placerestoration Program 6 can also be utilized directly for the following conditions Herpes Gingivitis Stomatitis 1 Clinical applications PROGRAM 6 seconds Acid etch bonding technique for composite restoration inlays onlays veneers Prozone tip Coro Prepare tooth surface as per standard procedure Apply and rinse etching gel Select 6 on display panel Follow steps 2 5 injecting 03 directly into the cavity to disinfect Apply bonding agent and restoration as normal V M PROGRAM 12 seconds Surgical disinfection Prozone tip Coro Extraction implant placement Disinfection of crowns posts inlays onlays veneers Dental hypersensitivity V M M M 18 Clinical applications PROGRAM 18 seconds Periodontal treatment gt Prozone tip Perio gt Debride and irrigate pocket as usual gt Select 18 on display panel gt Follow steps 2 5 applying to disinfect PROGRAM 24 seconds Endodontic treatment Prozone tip Endo Prepare and clean the canal system as per standard procedure When the canals are ready for obturation dry with paper points Select 24 on display panel Follow steps 2 5 injecting gas directly into canal to disinf
15. isplay CO After up to 100 hours of ozone generator working time CO will be indicated on the display panel as a remainder to check the ozone generation values Contact your distributor to arrange an inspection of the ozone concentration levels Display OU The device will limit the amount of ozone produced in case it runs continuously Over Used The allowed continuous running time is 15 minutes then the device allow to run as many time as the time it stay in standby 24 15 When error is detected the Prozone immediately returns to Standby mode error will interrupt a running treatment Activating any button will erase the error display and the Prozone will return to Standby mode Display E1 Air leakage detected Check for correct connection of gt Filter cartridge gt Handpiece tube gt Handpiece gt Prozone tip If the error remains refer to your Prozone dealer Display E2 Ozone detection No presence of ozone detected by the internal ozone sensor Check the filter status refer to Maintenance Filter and purge the air circuit with dry air by manually by pushing the 03 switch while the device is in standby If the error remains a re calibration of the device could be necessary due to the ageing of the Corona ceramic plate Refer to your Prozone dealer to proceed with re calibration Display E3 Hardware fault Hardware problem detected during the automatic self testing of the u
16. n power supply input lines IEC 61000 4 11 Power frequency 50 60Hz magnetic field IEC 61000 4 8 Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 29 Electromagnetics compatibility Electromagnetic Emissions The Prozone is suitable for use in the specified electromagnetic environment The customer and or user of the Prozone should assure that it is used in an electromagnetic environment as described below Emissions Test Compliance Electromagnetic Environment Guidance RF emission CISPR 11 Group 1 The product uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emission CISPR 11 Class B The product is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions Class A IEC 61000 3 2 Voltage fluctuations Complies flicker emission IEC 61000 3 3 30 Electromagnetic Immunity Immunity Test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 60601 1 2 6 kV contact 8 kV air 2 KV for power supply lines 1 for input output lines 1 kV differential mode 1 kV common mode Compliance Level 6 kV cont
17. ncy magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment 32 Electromagnetic Immunity RF portable equipment The product is intended for use in the electromagnetic environment specified below The customer or the user of the product should assure that it is used in such environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the product including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Conducted RF 3 Vrms 3 Vrms Recommended separation distance IEC 61000 4 6 150 kHz to 80 MHz d 1 2 P Radiated RF 3 V m 3 V m d 1 2 P 80 MHz to 800 MHz IEC 61000 4 3 0 MHz to 2 5 GHz d 2 3 P 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watt W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths form fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 33 Electromagnetic Immunity RF portable equipment NOTE 1 At 80 MHz and 800 MHz the higher frequency range
18. nit Switch ON OFF the unit and re start a treatment If the error remains refer to your Prozone dealer 25 Errors Display E4 Ozone sensor fault Hardware problem detected during the automatic self testing of the unit Switch ON OFF the unit and re start a treatment If the error remains refer to your Prozone dealer Display E5 Over pressure fault Over pressure inside the ozone chamber detected during the automatic self testing of the unit Re start the device with the handpiece cord removed If the error is cleared check if the air is blocked inside the tube handpiece or the tip If the error remains refer to your Prozone dealer 26 16 Environmental Conditions Operation Temperature Altitude Atmospheric Pressure Relative Humidity Transport and Storage Temperature Altitude Atmospheric Pressure Relative Humidity Recycling Prozone Foot control 5 C to 40 C 41 F to 104 F 390 m to 3 012 m 1 254 ft to 9 882 ft 20 kPa to 106 kPa 20 6 in Hg to 31 3 in Hg 15 95 non condensing to be compliant with IEC 60601 1 sub clause 44 5 20 C to 60 C 2 F to 140 F 390 m to 5 524 m 1 280 ft to 18 288 ft 50 kPa to 106 kPa 14 in Hg to 31 3 in Hg 15 to 95 non condensing The equipment contains many valuable materials Therefore return your equipment for material recycling via the relevant public collection system Main unit must be disposed as special electronic waste
19. uency of transmitter M 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 1 2 VP d 1 2 VP d 2 3 VP 0 01 0 12 m 0 12 0 23 0 1 0 38 0 38 0 23 1 1 2m 1 2m 2 3m 10 3 8m 3 8 7 3m 100 12m 12m 23m For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 35 Use only original approved by TTT accessories and spare parts REF 05864100 Prozone handpiece tube with connector REF 05875200 Prozone handpiece REF 05863400 Prozone filter cartridge REF 05863500 Prozone foot control REF 05863700 Prozone tips Coro 20 pcs REF 05863800 Prozone tips Endo 20 pcs REF 05863900 Prozone tips Perio 20 pcs V M M VV 19 Accessories 36 20 Warranty As manufacturer is liable for material or manufacturing defects within a warranty period of 24 months from the date of purchase TTT accepts no responsibility for damage caused by incorrect handling or by repairs carri
20. y other claims Patients at risk Do not use the Prozone on patients with respiratory conditions Cardiac Pacemaker Patients The use of the Prozone involves generation of magnetic fields which are below the interference threshold limit according to EN 60601 1 2 We do however advise that the Prozone is not used on such patients Pregnant Women and Infants Do not use the Prozone on these patients as the VME value is not available 13 Safety notes Mains The power supply should be connected to a hospital grade power outlet as applicable in your country Only connect to an earthed socket outlet Power Failure In the event of a power failure while the Prozone is in use the unit will reset itself once the mains power has been restored Safety in presence of a flammable substance In accordance with EN 60601 1 the control unit is not suitable for use in potentially explosive atmospheres or with potentially explosive mixtures of anaesthetic substances containing oxygen or nitrous oxide 14 9 Starting operation General Connect the end of the handpiece tube to the unit by sliding it over the connector until it is fully inserted Install the filter cartridge by screwing in clockwise Connect the mains cord Connect the foot control and secure it by turning the locking sleeve clockwise Fit the handpiece holder It can also be used on a mobile basis 1

Instructions for use

Contents

Download Pdf Manuals

Related Search

Related Contents