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KERR SonicFill Instructions For Use Manual

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Instructions for use
SonicFill Handpiece

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Summary of Contents for KERR SonicFill

  • Page 1 Instructions for use SonicFill Handpiece...
  • Page 2 Manufactured for: Kerr Corporation 1717 W. Collins Ave Orange CA 92867 U.S.A.
  • Page 3 User instructions 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.
  • Page 4 User instructions Symbols Refer to the Chapter on Safety/Warning symbols Important information for users and service technicians Thermodisinfectable...

  • Page 5: Target Group

    User instructions Can be sterilized with 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.
  • Page 6 Safety 2 Safety 2.1.1 Description of safety instructions: Warning symbol Warning symbol...
  • Page 7 Safety 2.1.2 Description of safety instructions: 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 for hazard prevention.
  • Page 8 Safety 2.1.3 Description of safety instructions: Description 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 to property or mild to moderate injuries.
  • Page 9 Safety 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.

  • Page 10: Safety Instructions

    Hazard to the care provider and patient. Stop working in 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 must be cleaned, serviced and stored...
  • Page 11 Safety CAUTION Premature wear and 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 periods of nonuse.
  • Page 12 Safety CAUTION 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.
  • Page 13 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 up according to the methods described in the Kerr instructions for use, and the care products and methods described therein must be...
  • Page 14 This service interval should take into account the frequency of use. Service may only be provided by repair shops that have undergone training by Kerr and that use original Kerr replacement parts.

  • Page 15: Product Description

    3 Product description SonicFill handpiece SonicFill handpiece is a dental handpiece in accordance 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 transforms into the more viscous...
  • Page 16 Product description 3.1 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.
  • Page 17 ▪ 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.

  • Page 18: Proper Use

    Product description Proper use: According to these 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 use.

  • Page 19: Technical Specifications

    Product description According to these regulations, the user is required to: ▪ only use properly 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 3 –...
  • Page 20 If adjustment is required, please see the directions for proper measurement and calibration of the handpiece pressure on page 25 of this manual. The SonicFill handpiece can be mounted on all MULTIflex couplings.

  • Page 21: Transportation And Storage Conditions

    Product description 3.3 Transportation and storage conditions CAUTION It 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 of 20 °C to 25 °C (68 °F to 77 °F).
  • Page 22 Product description 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...

  • Page 23: First Use

    First use 4 First use Mediated by a MULTIflex coupling, the 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 use, sterilise the medical device.

  • Page 24: Connection To Devices

    First use 4.1 Connection to devices WARNING Damage 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 uncontaminated according to ISO 7494-2.

  • Page 25: Installing The Multiflex Coupling

    First use 4.2 Installing the MULTIflex coupling ▶ Screw the MULTIflex LUX/MULTIflex LED coupling onto the turbine hose and tighten with the wrench.

  • Page 26: Check The O-Rings

    First use 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...

  • Page 27: Check The Pressure Using A Test Manometer

    3.5 bar (50 psi) is ideal . Between 3.5 - 4.2 bar (51 - 62 psi) the drive air will SonicFill handpiece. be automatically reduced within the SonicFill handpiece. The air consumption is approximately 20 - 40 NI/min. Insert the test manometer between the MULTIflex coupling and the SonicFill hand‐ piece. Adjust regulating ring on level 5. Pressure displayed: ▪...
  • Page 28 Operation 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.
  • Page 29 SonicFill handpiece to prevent damage 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 coupling during the treatment. ▶...

  • Page 30: Detaching The Sonicfill Handpiece

    Operation 5.2 Detaching the SonicFill handpiece ▶ Hold the MULTIflex (LUX) / MULTIflex LED coupling tight, and pull the SonicFill handpiece forward while twisting slightly.

  • Page 31: Inserting The Sonicfill Unidose Tips

    If the SonicFill Unidose tip is difficult to screw-on, this is due to a defect and the SonicFill Unidose tip must not be used since it may become de‐ tached during use. Check if the SonicFill Unidose tips are firmly connected by briefly starting-up...
  • Page 32 Operation...

  • Page 33: Removing The Sonicfill Unidose Tips

    Operation ▶ Push the SonicFill Unidose tips by hand into the corresponding opening of the SonicFill 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 ▶...

  • Page 34: Power Setting

    Operation 5.5 Power setting Use the regulating ring of the SonicFill handpiece to adjust the 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...
  • Page 35 Preparation methods according to ISO 17664 6 Preparation methods according to ISO 17664 6.1 Preparations at the site of use WARNING Hazard from nonsterile products. There is a risk of infection from contaminated medical devices. ▶ Take suitable personal protective measures. ▶...

  • Page 36: Preparations Before Cleaning

    The medical device must be dry when transporting it to the site of reprocessing. (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 from the SonicFill handpiece.
  • Page 37 Preparation methods according to ISO 17664 6.3 Cleaning CAUTION Malfunctions from cleaning in the ultrasonic unit. Defects in the product. ▶ Only clean manually or in a thermodisinfector.

  • Page 38: Cleaning: Manual Cleaning - External

    Preparation methods according to ISO 17664 6.3.1 Cleaning: Manual 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.

  • Page 39: Cleaning: Automated External Cleaning

    Preparation methods according to ISO 17664 6.3.2 Cleaning: Automated external cleaning Kerr recommends thermodisinfectors in accordance with EN ISO 15883 that are operated with al‐ kaline cleaning agents at a pH of max. 10 (e.g. Miele G 7781 / G 7881 – validation was performed with the ""VARIO-TD"...
  • Page 40 Preparation methods according to ISO 17664 ▶ In order to prevent negative effects on the medical device made by Kerr, make sure that the interior and the exterior of the medical device are dry, and then lubricate immediately with care agents from the Kerr care system.

  • Page 41: Disinfection: Manual Disinfection - External

    Preparation methods according to ISO 17664 6.4.1 Disinfection: Manual disinfection - external Kerr recommends the following products based on material compatibility. ▪ CaviCide made by Metrex...
  • Page 42 Preparation methods according to ISO 17664 Consumables required: Cloths for wiping off the medical device. Spray the disinfectant 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 for use of the disinfectant.

  • Page 43: Disinfection: Machine Disinfection - External And Internal

    6.4.2 Disinfection: Machine disinfection - external and internal Kerr recommends thermodisinfectors in accordance with EN ISO 15883 that are operated with al‐ kaline cleaning agents at a pH of max. 10 (e.g. Miele G 7781 / G 7881 – validation was performed with the ""VARIO-TD"...

  • Page 44: Automatic Drying

    Preparation methods according to ISO 17664 ▶ In order to prevent negative effects on the medical device made by Kerr, make sure that the interior and the exterior of the medical device are dry, and then lubricate immediately with care agents from the Kerr care system.
  • Page 45 Preparation methods according to ISO 17664 Note Please follow the instructions for use of the thermodisinfector (compressed air quality - see the Warning under "Start-up").

  • Page 46: Care Products And Systems - Servicing

    Preparation methods according to ISO 17664 6.6 Care products and systems - Servicing CAUTION Premature wear and malfunctions from improper servicing and care. Reduced product life. ▶ Perform proper care regularly!
  • Page 47 Preparation methods according to ISO 17664 Note Kerr guarantees the proper function of Kerr products only if the care products listed by Kerr un‐ der accessories are used, as these have been tested for proper use on our products. 6.6.1 Care products and systems - Servicing: Servicing involving SonicFill Hand‐...
  • Page 48 Preparation methods according to ISO 17664 Note If the oil leakage is bothersome, once weekly servicing is sufficient. ▶ Remove the SonicFill Unidose Tips. ▶ Cover the product with the cellulose bag.
  • Page 49 Preparation methods according to ISO 17664 ▶ Place the product on the SonicFill MULTIflex coupling, and press 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.
  • Page 50 Preparation methods according to ISO 17664 6.8 Sterilization Sterilization in a steam sterilizer (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 cycle.
  • Page 51 Preparation methods according to ISO 17664 CAUTION Contact corrosion due to moisture. Damage to 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‐ able.
  • Page 52 Preparation methods according to ISO 17664 The medical device has a maximum temperature resistance up to 138 ℃ (280.4 °F).
  • Page 53 Preparation methods according to ISO 17664 (Depending on the available autoclave,) select a suitable procedure from the following sterilisation processes: ▪ Autoclave with pre-vacuum: – at least 3 minutes at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F) Drying time: 20 min.
  • Page 54 Preparation methods according to ISO 17664 6.9 Storage 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.
  • Page 55 Tools 7 Tools Obtainable from an authorized Kerr distributor. Material summary Mat. no. SonicFill Handpiece Lubrication Spray 35207 SonicFill MULTIflex coupling 35134...

  • Page 56: Terms And Conditions Of Warranty

    In order to take advantage of this limited warranty, the defective product must be returned to Kerr. In no event shall Kerr be liable for any indirect, incidental, or consequential damages. EXCEPT AS EXPRESSLY PROVIDED ABOVE, THERE ARE NO WAR‐...

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