KERR SonicFill Скачать руководство пользователя страница 17 | Manualshive

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This medical device is

▪ intended for dental treatment only. Any other type of use or alteration to the product is im‐

permissible and can be hazardous.

The SonicFill handpiece must be used exclusively in combination with the SonicFill Unidose

tip for filling dental cavities with composite materials.

▪ A medical device according to relevant national statutory regulations.

Product description

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Содержание SonicFill

Страница 1: ...Instructions for use SonicFill Handpiece...

Страница 2: ...Manufactured for Kerr Corporation 1717 W Collins Ave Orange CA 92867 U S A...

Страница 3: ...1 User instructions Dear user Congratulations on purchasing this Kerr quality product Following the instructions below will allow you to work smoothly economically and safely User instructions 1...

Страница 4: ...Symbols Refer to the Chapter on Safety Warning symbols Important information for users and service technicians Thermodisinfectable User instructions 2...

Страница 5: ...th steam at 134 C 1 C 1 C 273 F 1 6 F 1 6 F Action request Target group This document is intended for dentists and their assistants The section on starting up is also intended for service technicians...

Страница 6: ...2 Safety 2 1 1 Description of safety instructions Warning symbol Warning symbol Safety 4...

Страница 7: ...ructions Structure DANGER The introduction describes the type and source of the hazard This section describes the potential consequences of non observance The optional step includes necessary measures...

Страница 8: ...n of danger levels The safety instructions cited herein with the three levels of danger will help avert property damage and injury CAUTION CAUTION indicates a hazardous situation that can cause damage...

Страница 9: ...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 Safety 7...

Страница 10: ...case of damage irregular noise during operation excessive vibration unusual build up of heat or if the SonicFill Unidose tip cannot be firmly held Before extended periods of non use the instrument mus...

Страница 11: ...malfunctioning from improper storage during long periods of nonuse Reduced product life The medical device should be cleaned serviced and stored in a dry location according to instructions before long...

Страница 12: ...ON Injury or damage due to wear If you notice uneven operating noises excessive or unexpectedly low vibrations or the SonicFill Unidose tip coming undone Stop working and contact service support Safet...

Страница 13: ...a rubber dam for safety reasons The following persons are authorized to repair and service Kerr products Technicians specially trained by Kerr To ensure proper function the medical device must be set...

Страница 14: ...ensed shop to clean service and check the functioning of the medical device This service interval should take into account the frequency of use Service may only be provided by repair shops that have u...

Страница 15: ...cordance with ISO 15606 The handpiece is de signed for sound activated dispensation of a composite material that has a greatly reduced vis cosity during the dispensing process and subsequently quickly...

Страница 16: ...1 Purpose Proper use Purpose The SonicFill handpiece is a dental delivery system intended to be used to dispense SonicFill a dental restorative resin directly into dental cavities Product description...

Страница 17: ...to the product is im permissible and can be hazardous The SonicFill handpiece must be used exclusively in combination with the SonicFill Unidose tip for filling dental cavities with composite material...

Страница 18: ...e provisions the medical device is only for the described use in conformance with the applicable health and safety regulations the applicable accident prevention regulations and these instructions for...

Страница 19: ...operating equipment use the equipment for the proper purpose to protect himself the patient and third parties from danger to avoid contamination from the product 3 2 Technical Specifications Drive air...

Страница 20: ...l unit is set between 2 1 3 5 bar 30 50 psi which is normally the case when a turbine is used no adjustment should be necessary If adjustment is required please see the directions for proper measureme...

Страница 21: ...is hazardous to start up the medical device after it has been stored refrigerated This can cause the medical device to malfunction Prior to start up very cold products must be heated to a temperature...

Страница 22: ...Temperature 20 C to 70 C 4 F to 158 F Relative humidity 5 RH to 95 RH absence of condensation Air pressure 700 hPa to 1060 hPa 10 psi to 15 psi Protect from moisture Product description 20...

Страница 23: ...he SonicFill handpiece can be connected to any turbine hose of a treatment unit WARNING Hazard from non sterile products Infection hazard for care provider and patient Before first use and after each...

Страница 24: ...e from soiled and moist drive air Contaminated and moist drive air can cause malfunctions and lead to premature bearing wear Always make sure that the supply of drive air is dry clean and uncontaminat...

Страница 25: ...4 2 Installing the MULTIflex coupling Screw the MULTIflex LUX MULTIflex LED coupling onto the turbine hose and tighten with the wrench First use 23...

Страница 26: ...4 3 Check the O rings CAUTION Missing or damaged O rings Malfunctions and premature failure Make sure that all O rings are on the coupling and undamaged Number of available O rings 5 First use 24...

Страница 27: ...2 bar 51 62 psi the drive air will be automatically reduced within the SonicFill handpiece The air consumption is approximately 20 40 NI min Insert the test manometer between the MULTIflex coupling a...

Страница 28: ...5 Operation 5 1 Attaching the SonicFill handpiece Place the SonicFill handpiece exactly on the MULTIflex LUX MULTIflex LED coupling and push it to the rear until it audibly locks Operation 26...

Страница 29: ...to the light source CAUTION Ensure that the SonicFill handpiece is firmly seated on the coupling The SonicFill handpiece can be a hazard for patient and user if it inadvertently comes undone on the co...

Страница 30: ...5 2 Detaching the SonicFill handpiece Hold the MULTIflex LUX MULTIflex LED coupling tight and pull the SonicFill handpiece forward while twisting slightly Operation 28...

Страница 31: ...d to the SonicFill handpiece Before each treatment pull on the SonicFill Unidose tip to see if it is securely attached to the instrument If the SonicFill Unidose tip is difficult to screw on this is d...

Страница 32: ...Operation 30...

Страница 33: ...Fill handpiece using moderate pressure and turn the handpiece in a clockwise direction screw ing it into the SonicFill tip 5 4 Removing the SonicFill Unidose Tips Unscrew the SonicFill Unidose tips by...

Страница 34: ...e dispensed quantity Level 1 low level 5 high Dispensing with a variable foot control positions Variable foot controls allow the dispensing rate to be controlled with different foot pedals In this cas...

Страница 35: ...he site of use WARNING Hazard from nonsterile products There is a risk of infection from contaminated medical devices Take suitable personal protective measures Remove all residual cement composite or...

Страница 36: ...sing do not place in any type of solution The medical device should be reprocessed as quickly as possible after the treatment 6 2 Preparations before cleaning Remove the SonicFill Unidose tips by hand...

Страница 37: ...6 3 Cleaning CAUTION Malfunctions from cleaning in the ultrasonic unit Defects in the product Only clean manually or in a thermodisinfector Preparation methods according to ISO 17664 35...

Страница 38: ...al cleaning external Accessories required Tap water 30 C 5 C 86 F 10 F Brush e g medium hard toothbrush Brush under running tap water using e g a medium hardness toothbrush Preparation methods accordi...

Страница 39: ...h the VARIO TD programme neodisher mediclean cleaning agent neodisher Z neutral isation agent and neodisher mielclear rinsing agent and extends only to the compatibility of materials with respect to K...

Страница 40: ...medical device are dry and then lubricate immediately with care agents from the Kerr care system 6 4 Disinfection CAUTION Malfunctioning from using a disinfectant bath or disinfectant containing chlo...

Страница 41: ...6 4 1 Disinfection Manual disinfection external Kerr recommends the following products based on material compatibility CaviCide made by Metrex Preparation methods according to ISO 17664 39...

Страница 42: ...isinfectant on a cloth then thoroughly wipe down the medical device and leave the disinfectant to soak in according to the instructions from the disinfectant manufacturer Note Follow the instructions...

Страница 43: ...ormed with the VARIO TD programme neodisher mediclean cleaning agent neodisher Z neutral isation agent and neodisher mielclear rinsing agent and extends only to the compatibility of materials with res...

Страница 44: ...y and then lubricate immediately with care agents from the Kerr care system 6 5 Drying Manual Drying Blow off the outside and inside with compressed air until water drops are no longer visible Automat...

Страница 45: ...Note Please follow the instructions for use of the thermodisinfector compressed air quality see the Warning under Start up Preparation methods according to ISO 17664 43...

Страница 46: ...are products and systems Servicing CAUTION Premature wear and malfunctions from improper servicing and care Reduced product life Perform proper care regularly Preparation methods according to ISO 1766...

Страница 47: ...used as these have been tested for proper use on our products 6 6 1 Care products and systems Servicing Servicing involving SonicFill Hand piece Lubrication Spray Kerr recommends servicing the product...

Страница 48: ...Note If the oil leakage is bothersome once weekly servicing is sufficient Remove the SonicFill Unidose Tips Cover the product with the cellulose bag Preparation methods according to ISO 17664 46...

Страница 49: ...ss the spray button for one second 6 7 Packaging Note The sterilization bag must be large enough for the instrument so that the bag is not stretched Seal each medical device individually in a sterilis...

Страница 50: ...er autoclave in accordance with EN 13060 ISO 17665 1 CAUTION Premature wear and malfunctions from improper servicing and care Reduced product life Service the medical device before each sterilization...

Страница 51: ...o product Immediately remove the product from the steam steriliser after the sterilisation cycle Note Remove the SonicFill Unidose tip before sterilization The SonicFill Unidose tips are non steriliz...

Страница 52: ...The medical device has a maximum temperature resistance up to 138 280 4 F Preparation methods according to ISO 17664 50...

Страница 53: ...C 273 F 1 6 F 7 4 F Drying time 20 min Autoclave using the gravity method at least 10 minutes at 134 C 1 C 4 C 273 F 1 6 F 7 4 F or alternatively at least 60 minutes at 121 C 1 C 4 C 250 F 1 6 F 7 4...

Страница 54: ...e Prepared products must be stored protected from germs as far as possible and dust in a dry dark cool room Note Comply with the expiry date of the sterilised items Preparation methods according to IS...

Страница 55: ...7 Tools Obtainable from an authorized Kerr distributor Material summary Mat no SonicFill Handpiece Lubrication Spray 35207 SonicFill MULTIflex coupling 35134 Tools 53...

Страница 56: ...err s option to replacement of the defective product or part thereof or reimbursement of the ac tual cost of the defective product In order to take advantage of this limited warranty the defective pro...

Страница 57: ......

Страница 58: ...1 007 6793 kb 20120619 05 en...

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