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13, CAUTION Swallowing or aspiration of the SonicFill Unidose tip by the patient. ▶ Before each treatment involving the SonicFill handpiece, insert 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 up according to the methods described in the Kerr instructions for use, and the care products and methods des…
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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
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53, (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. ▪ • 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 °F) Drying time for us…
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35, KERR SonicFill 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. ▶ Remove all residual cement, composite or blood without delay. Preparation methods according to ISO 17664 33
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33, ▶ 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 ▶ Unscrew the SonicFill Unidose tips by hand from the SonicFill handpiece through a counter‐ clockwise rotation. Operation 31
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20, Frequency 5 – 6 kHz Ejection force 0 to 170 N Note that the values above apply to the pressure within the handpiece and not to the dental unit itself. If the dental 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 measurement and calibration of the handpiece pressure on page 25 of this manual. The SonicFill handpiece can…
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24, 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. First use 22
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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
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17, 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 15
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19, 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 – 4.2 bar (43 – 61 psi) Air consumption 20 – 40 NL/min Product description 17
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50, 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. Preparation methods according to ISO 17664 48
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44, KERR SonicFill ▶ 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. 6.5 Drying Manual Drying ▶ Blow off the outside and inside with compressed air until water drops are no longer visible. Automatic Drying The drying procedure is normally part of the disinfection program o…
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38, 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. Preparation methods according to ISO 17664 36
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42, KERR SonicFill 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. Preparation methods according to ISO 17664 40
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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
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7, KERR SonicFill 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. Safety 5
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9, KERR SonicFill 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
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54, KERR SonicFill 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. Preparation methods according to ISO 17664 52
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18, KERR SonicFill 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. Product description 16
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43, KERR SonicFill 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" 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…
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51, 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. Preparation methods according to ISO 17664 49
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56, 8 Terms and conditions of warranty Kerr’s technical advice, whether verbal or in writing, is designed to assist dentists in using Kerr’s product. The dentist assumes all risk and liability for damages arising out of the improper use of Kerr’s product. In the event of a defect in material or workmanship, Kerr’s liability is limited, at Kerr’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 w…
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11, KERR SonicFill 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. Safety 9
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21, 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). Product description 19
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47, 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‐ piece Lubrication Spray Kerr recommends servicing the product after each use after each automatic cleaning and before each sterilization. Preparation methods according to ISO 17664 45
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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
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34, 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 case, it is recommended to set the regulating ring on the handpiece to 5. Operation 32
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