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Instructions for use PROPHYflex 4

7 Reprocessing steps in accordance with ISO 17664 | 7.3 Manual Reprocessing

7.3.2 Manual internal cleaning

Manual internal cleaning of the PROPHYflex 4 is not applicable. For effective re-
processing, the inside of the device must be subjected to automated cleaning in
a cleaning and disinfection unit in accordance with ISO 15883-1.

7.3.3 Manual external disinfection

WARNING

Incomplete disinfection.

Infection hazard.

▶

Only use disinfection procedures that are verified to be bactericidal, fungi-
cidal and virucidal.

▶

If the disinfectants used do not meet these requirements, the process must
be concluded by disinfection of the unit(s) without packaging using a steam
steriliser.

NOTICE

Never disinfect the handpiece with chloride-containing products.

Malfunction and material damage.

▶

Only disinfect in a washer disinfector or manually.

KaVo recommends the following products based on compatibility of the materi-
als. The microbiological efficacy must be ensured by the disinfectant manufac-
turer and proven by an expert opinion.

Approved disinfectants:

▪ Mikrozid AF made by Schülke & Mayr (liquid or cloths)

▪ FD 322 made by Dürr

▪ CaviCide made by Metrex

Consumables required:

▪ Cloths for wiping the medical device.

▶

Spray the disinfectant on a cloth, then wipe down the medical device and
allow the disinfectant to act according to the instructions of the
disinfectant manufacturer.

▶

Follow the instructions for use of the disinfectant.

7.3.4 Manual internal disinfection

Manual internal disinfection of the PROPHYflex 4 is not applicable. For effective
reprocessing, the inside of the device must be subjected to automated cleaning
in a cleaning and disinfection unit in accordance with ISO 15883-1.

7.3.5 Manual drying

Manual drying of the PROPHYflex 4 is not applicable. For effective reprocessing,
the inside of the device must be subjected to automated cleaning in a cleaning
and disinfection unit in accordance with ISO 15883-1.

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Содержание PROPHYflex 4

Страница 1: ...Instructions for use PROPHYflex 4 ...

Страница 2: ...Distributed by KaVo Dental GmbH Bismarckring 39 D 88400 Biberach Phone 49 7351 56 0 Fax 49 7351 56 1488 Manufacturer Kaltenbach Voigt GmbH Bismarckring 39 D 88400 Biberach www kavo com ...

Страница 3: ...7 5 5 Screwing in the cannula 17 5 6 Unscrewing the cannula 17 5 7 Instructions for use for PROPHYflex Powder PROPHYpearls PROPHYflex Perio Powder 18 6 Troubleshooting 19 6 1 Cleaning a blocked cannula 19 6 2 Cleaning a clogged main body 20 7 Reprocessing steps in accordance with ISO 17664 22 7 1 Preparation at the site of use 22 7 2 Disassembly 22 7 3 Manual Reprocessing 22 7 3 1 Manual external ...

Страница 4: ...ng 27 7 5 Care products and systems Servicing 27 7 6 Packaging 27 7 7 Sterilisation 28 7 8 Storage 28 8 Auxiliary equipment 29 9 Terms and conditions of warranty 31 Instructions for use PROPHYflex 4 Table of contents 4 34 ...

Страница 5: ... KaVo Repair Service directly 49 0 7351 56 1900 service reparatur kavokerr com Target group This document is intended for dentists and their assistants The startup section is also intended for service technicians General marks and symbols Refer to the chapter on Safety Warning symbol Important information for users and service technicians Action request CE mark European Community A product bearing...

Страница 6: ...tions Humidity Protect from moisture Protect from impact HIBC Code Hazard levels The warning and safety notes in this document must be observed to prevent personal injury and material damage The warning notes are designated as shown below DANGER In cases which if not prevented directly lead to death or severe in jury WARNING In cases which if not prevented could lead to death or severe in jury CAU...

Страница 7: ...e Reprocess the product and accessories appropriately before disposal In the case of injury to soft tissue do not continue treatment in the oral cavity with compressed air driven instruments 2 2 Air embolism and skin emphysema There is a danger that the insufflation of spray can cause air embolisms and skin emphysema Avoid the insufflation of spray in open wounds The improper use of the product mi...

Страница 8: ...proved for combination with the product by the manufacturer Only use accessories that are equipped with standardised interfaces Only use consumables that have been approved for combination with the product by the manufacturer Do not make any modifications to the device unless these have been ap proved by the manufacturer of the product 2 5 Qualification of personnel Application of the product by u...

Страница 9: ...inance KaVo recommends specifying in house service intervals where the medical device is brought to a professional shop for cleaning servicing and a func tion check Defined the service interval depending on the frequency of use Cleansers and disinfectants that have not been approved can damage the plastic housing leading to hairline cracks and other damage which can ulti mately lead to hazards 2 8...

Страница 10: ...zardous The medical device is intended for the following applications Removal of discolouration and bac terial plaque orthodontics cleaning prior to fissure sealing prosthetics con servative and aesthetic dentistry Please refer also to the Instructions for Use A medical device according to relevant national statutory regulations Proper use According to these provisions this medical device may only...

Страница 11: ... patient and third parties from hazards and to prevent contamination from the product 3 2 Technical data Drive pressure 3 2 5 bar 46 73 psi Air consumption 10 13 Nl min Water pressure 1 0 2 5 bar 15 36 psi Spray water flow approx 35 80 cm3 Spray air pressure 1 0 2 5 bar 15 36 psi Attachable to all MULTIflex LUX MULTIflex LED couplings 11 34 ...

Страница 12: ... Cannula Powder container 3 003 0520 3 003 1138 3 002 8136 1 x Short gripping sleeve Cannula 3 003 2607 3 003 1138 1 x Powder container Rubber cover supra 3 002 8136 3 004 4708 1 x Cleaning drill 0 573 0321 1 x Nozzle pin 0 573 6052 1 x Wrench for cannula 3 004 6351 1 x O rings for powder container and coupling in terface to the gripping sleeve can be ordered individually See also 2 8 Tools and co...

Страница 13: ...ditions NOTICE Startup after refrigerated storage Malfunction Prior to startup very cold products must be heated up to a temperature of 20 C to 25 C 68 F to 77 F Temperature 20 C to 70 C 4 F to 158 F Relative humidity 5 RH to 85 RH absence of condensation Air pressure 700 hPa to 1060 hPa 10 psi to 15 psi Protect from moisture 13 34 ...

Страница 14: ...ing air can cause malfunctions Make sure that the supply of cooling air is dry clean and uncontaminated according to EN ISO 7494 2 4 1 Installing the MULTIflex coupling WARNING Detachment of the medical device during treatment A medical device that is not properly locked can release from the MULTIflex coupling during treatment Before each use check if the medical device is securely locked onto the...

Страница 15: ...treatment Before each use check if the medical device is securely locked onto the MULTIflex coupling Mount the medical device accurately on the MULTIflex LUX MULTIflex LED coupling and push it backward until the coupling audibly locks in the medical device Check if the medical device is securely seated on the coupling by pulling on it 5 2 Remove the medical device Grasping the coupling twist the m...

Страница 16: ...before use To screw on the powder container and to tighten it keep the container up right and turn to the right Adjusting the powder volume The powder quantity can be controlled at 3 levels using the adjusting ring The highest level is suitable for supragingival treatment and offers full cleaning power The medium level is suitable for sub and supragingival treatment and en ables gentle cleaning at...

Страница 17: ...UTION Cannula falls off during the treatment Detachment of the cannula is a hazard for patient and user Visual inspection after each time the cannula is inserted with the wrench for the cannula Before commencing the treatment check that there is no gap between the cannula and the gripping sleeve Insert the cannula in the gripping sleeve with the wrench for the cannula and screw it in clockwise whi...

Страница 18: ...etic dentistry Cleaning of tooth sur faces Removal of stains and plaque Orthodontics and prosthetics pre and after treatment of ad hesive surfaces When Subgingival treatment Removal of period ontal biofilm For follow up treat ment after the initial use in periodontal therapy Preservation of dental implants including titanium polish PROPHYflex powder PROPHYpearls PROPHYflex Perio Powder from red to...

Страница 19: ...the PROPHYflex on the MULTIflex coupling and blow through the air and water channels Switch the water off and blow through the air and water channels again 6 1 Cleaning a blocked cannula Unscrew the cannula in anticlockwise direction using the wrench Slide the nozzle needle into the cannula from the front while rotating it Then slide the nozzle needle into the cannula from the back while rotating ...

Страница 20: ...crew the powder container anticlockwise Push the nozzle needle through the aperture of the nozzle Use the cleaning drill to clean or remove obstructions from the media tube Then blow through with compressed air If the clogging persists Use the wrench for cannula to unscrew the nozzle by placing the lateral re cess of the wrench on the nozzle and unscrewing the nozzle ...

Страница 21: ...x 4 6 Troubleshooting 6 2 Cleaning a clogged main body Use the cleaning drill to clean or remove obstructions from the media tube from the front and the back Tighten the nozzle with the wrench again Blow compressed air through 21 34 ...

Страница 22: ...ng always wear protect ive gloves Remove all residual cement composite or blood immediately Do not place in solutions or similar substance 7 2 Disassembly WARNING Incomplete reprocessing Infection hazard To ensure complete reprocessing of all parts the medical device needs to be disassembled before reprocessing Unscrew the powder container Pull the gripping sleeve off Remove the cannula from the g...

Страница 23: ...ends the following products based on compatibility of the materi als The microbiological efficacy must be ensured by the disinfectant manufac turer and proven by an expert opinion Approved disinfectants Mikrozid AF made by Schülke Mayr liquid or cloths FD 322 made by Dürr CaviCide made by Metrex Consumables required Cloths for wiping the medical device Spray the disinfectant on a cloth then wipe d...

Страница 24: ...l and virucidal If the disinfectants used do not meet these requirements the process must be concluded by disinfection of the unit s without packaging using a steam steriliser NOTICE Never disinfect the handpiece with chloride containing products Malfunction and material damage Only disinfect in a washer disinfector or manually NOTICE Never reprocess this medical device in an ultrasonic device Mal...

Страница 25: ...nal cleaning Automated internal and ex ternal dis infection Sterilisa tion Main body Gripping sleeve Cannula Adapter Perio Tip Gripping sleeve and cannula Adapter Perio Tip Powder container not applicable Cover for powder con tainer not applicable Wrench for cannulas not applicable possible Note Adapters are needed for automated cleaning Order adapter separately See also 2 8 Tools and consumables ...

Страница 26: ... internal and external cleaning as well as internal and external disinfection Miele Series G 7881 7891 Main body required material Cleaning cover PROPHYflex 4 3 004 6658 Reprocessing with Miele AUF Ad apter Gripping sleeve required material Cleaning in Miele sieve basket Cannula Adapter Perio Tip required material Cleaning adapter PROPHYflex 4 long 3 004 6640 Reprocessing with Miele AUF Ad apter G...

Страница 27: ... rinsing agent For programme settings as well as cleansers and disinfectants to be used please refer to the Instructions for Use of the washer disinfector 7 4 5 Automated drying The drying procedure is normally part of the cleaning program of the thermod isinfector Note Please observe the instructions for use of the thermodisinfector In order to prevent impairment of the KaVo medical device make s...

Страница 28: ...y in the cold state The KaVo medical device has a maximum temperature resistance up to 138 280 4 F Select a suitable procedure depending on the available autoclave from the fol lowing sterilisation processes Steriliser with triple pre vacuum at least 3 minutes at 134 C 1 C 4 C 273 F 1 6 F 7 4 F Steriliser using the gravity method at least 10 minutes at 134 C 1 C 4 C 273 F 1 6 F 7 4 F or alternativ...

Страница 29: ...3 004 2324 Long gripping sleeve Mat no 3 003 0520 Short gripping sleeve Mat no 3 003 2607 Cleaning adapter PROPHYflex 4 long Mat no 3 004 6640 Cleaning cover PROPHYflex 4 Mat no 3 004 6658 Cleaning adapter PROPHYflex 4 Mat no 3 004 8509 Cleaning adapter PROPHYflex 4 S Mat no 3 004 8523 PROPHYflex 4 Perio Kit Mat no 1 011 9403 O ring for powder container Mat no 3 003 0608 O ring for coupling interf...

Страница 30: ...15 Mat no 1 007 0016 Mat no 1 007 0017 PROPHYpearls neutral Pack of 80 sticks Mat no 1 010 1826 PROPHYpearls mint Pack of 80 sticks PROPHYpearls peach Pack of 80 sticks PROPHYpearls orange Pack of 80 sticks PROPHYpearls black currant Pack of 80 sticks Mat no 1 010 1828 Mat no 1 010 1829 Mat no 1 010 1830 Mat no 1 010 1831 PROPHYpearls neutral 4 bottles containing 250g each Mat no 1 010 1798 PROPHY...

Страница 31: ...r consequences that have arisen or may arise from natural wear improper handling cleaning or maintenance non compliance with operating maintenance or connection instructions calcination or corrosion contaminated air or water supplies or chemical or electrical factors deemed abnormal or impermissible in accordance with KaVo s instructions for use or other manufacturer s instructions The warranty gr...

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