Instructions for use
For SONICflex tips paro - REF 0.571.0371,
paro A - REF 1.006.2020
Always be on the safe side.
Page 1: ...Instructions for use For SONICflex tips paro REF 0 571 0371 paro A REF 1 006 2020 Always be on the safe side ...
Page 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 ...
Page 3: ...Cflex 9 5 2 Instructions for use 9 6 Preparation methods according to ISO 17664 12 6 1 Preparation at the site of use 12 6 2 Preparation before cleaning 12 6 3 Cleaning 12 6 3 1 Manual cleaning of the exterior 13 6 3 2 Manual cleaning of the interior 13 6 3 3 Mechanical cleaning of the exterior and interior 13 6 4 Disinfection 13 6 4 1 Manual disinfection of the the exterior 14 6 4 2 Manual disinf...
Page 4: ... service technicians Action request CE mark European Community A product bearing this mark meets the requirements of the applicable EC directive Can be steam sterilised at 134 C 1 C 4 C 273 F 1 6 F 7 4 F Thermodisinfectable Target group This document is intended for dentists and their assistants The section on start ing up is also intended for service technicians Instructions for use For SONICflex...
Page 5: ... to property or mild to moderate injuries WARNING WARNING indicates a hazardous situation that can cause death or serious injury DANGER DANGER indicates a hazardous situation that can directly cause death or serious injury 2 2 Purpose Proper use This medical device is only intended for dental treatment Any other type of use or alteration to the product is impermissible and can be hazardous The SON...
Page 6: ...ods of nonuse Reduced product life The medical device should be cleaned serviced and stored in a dry location according to instructions before long periods of nonuse WARNING Hazards for the care provider and the patient In the case of damage irregular running noise excessive vibration un typical warming or when the cutter or grinder cannot be held Do not use further and notify Service CAUTION Haza...
Page 7: ...anging the SONICflex para tips every 9 12 monthsSONICflex paro Spitzen auszutauschen CAUTION Risk of injury and infection when changing the SONICflex tips This can substantially endanger the user Use gloves or finger stalls whenever you check insert or remove the SONICflex tips CAUTION The SONICflex tips may break if the wrong or excessive output is used This can endanger the user and patient Do n...
Page 8: ... 2000 NM LM 2004 LM 2003 2003 L xx Tip identification by 2 digit number Tips with short thread for use with KaVo SONICflex quick 2008 xxA Tip identification by 2 digit number and capital letter A 3 2 Transportation and storage conditions CAUTION It is hazardous to start up the medical device after it has been stored strongly refrigerated This can cause the medical device to malfunction Prior to st...
Page 9: ... RH to 95 RH absence of condensation Air pressure 700 hPa to 1060 hPa 10 psi to 15 psi Protect from moisture Instructions for use For SONICflex tips paro REF 0 571 0371 paro A REF 1 006 2020 3 Product description 3 2 Transportation and storage conditions 7 17 ...
Page 10: ... sure that the tip s end always faces into the opening of the torque spanner The torque wrench is for changing the working tips of the SONICflex and to pro tect against injury The torque wrench can be screwed in more quickly by holding it at the rear thin grip area The large diameter is used for tightening and removal Note The tip is properly gripped when the torque wrench slips Note When the SONI...
Page 11: ...e This tip set can be used for initial treatment and regular recall Regular recall treatments are very important for successful periodontal treatment to remove pathogenic plaque and to clean the root surface This should reduce the formation of plaque Previously the dentist only had sharp edged tips or hand instruments available for this purpose With this new set of tips subgingival plaque and endo...
Page 12: ...tip is held in the hand with the thread visible the angle to the right or left is easy to identify The SONICflex paro tips are designed for use in the following areas 60 60 A SONICflex paro straight no 60 60 A all quadrants 61 61 A SONICflex paro left angled no 61 61 A mandible left vestibular mandible right lingual maxilla right vestibular maxilla left lingual 62 62 A SONICflex paro right angled ...
Page 13: ...working end of the SONICflex paro tip should not be placed on the root surface Only the side surfaces of the SONICflex paro tips should be used for working You can receive information at www kavo com Instructions for use For SONICflex tips paro REF 0 571 0371 paro A REF 1 006 2020 5 Operation 5 2 Instructions for use 11 17 ...
Page 14: ...e If a sterile coolant is used the SONICflex tips must be rinsed with spray water after each use to prevent crystallisation in the tips Remove all residual cement composite or blood without delay The medical device must be dry when transported for reconditioning Do not place it in a solution or similar Reprocess the medical device as soon as possible after treatment Prepare the SONICflex instrumen...
Page 15: ...ru ment KaVo recommends thermodisinfectors in accordance with ISO 15883 1 e g Miele G 7781 G 7881 Validation was performed with the program VARIO TD the cleaner neodisher mediclean the neutraliser neodisher Z and rinse neodisher mielclear and only refers to the material compatibility with KaVo products Note Insert the instrument with tip screwed on into the adapter for interior cleaning in the the...
Page 16: ...5883 1 The interior of this product is not designed for manual disinfection 6 4 3 Mechanical disinfection of the exterior and interior Note Before setting up screw the SONICflex tips clockwise onto the SONICflex instru ment KaVo recommends thermodisinfectors in accordance with ISO 15883 1 e g Miele G 7781 G 7881 Validation was performed with the program VARIO TD the cleaner neodisher mediclean the...
Page 17: ...rilisation procedure Note The SONICflex can also be sterilised in the sterilisation tray Individually weld the medical device in the sterilised item packaging such as KaVo STERIclave bags Mat no 0 411 9912 Tips with short thread and marked A only fit in green mounts Tips with long thread fit in blue and green mounts 6 7 Sterilisation Sterilisation in a steam steriliser Autoclave EN 13060 ISO 17665...
Page 18: ...inutes at 134 C 1 C 273 F 1 8 F Drying time 20 min Autoclave with the gravitation method for at least 10 minutes at 134 1 C 1 C 273 F 1 8 F Drying time 30 min Autoclave with the gravitation method for at least 60 minutes at 121 1 C 250 F 1 8 F Drying time 30 min Follow the manufacturer s instructions for use 6 8 Storage Prepared products must be stored protected from germs as far as possible and d...
Page 19: ...cialist supplier Material summary Mat no Torque wrench 1 000 4887 Nozzle needle 0 410 0911 Sterilisation tray 0 411 9101 STERIclave bags 0 411 9912 Instructions for use For SONICflex tips paro REF 0 571 0371 paro A REF 1 006 2020 7 Tools 17 17 ...
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