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Instruction manual LB41/11P 0123 1 Explanation of symbols See chapter 2. Safety Important information for the user Product can be sterilized in a steam sterilizer (Autoclave) Can be used in thermal disinfectors CE-mark – Confirms that this product fulfills all requirements for medical products Reference number Serial number 2 Safety...
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→ Before storage, clean, maintain and dry the instrument according to the norm. Store in the original packing, dry and dust- CAUTION proof. We recommend an annual check-up and maintenance of the entire spindle system by MK-dent or by MK-dent authorized personnel. 3 Product description This manual can be used for the following MK-dent products:...
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4 Putting into service and operation WARNING Risk of infection for patients and operator due to non-sterile instruments → Before the first and after each further use the instrument must be processed and sterilized as defined in chapter 5 Processing WARNING according to ISO 17664.
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5.3.2 Mechanical cleaning and disinfection of the interior and the exterior MK-dent recommends thermal disinfectors that fulfill the EN ISO 15883-1 requirements and are approved by the manufacturer for the straight- and contra angle, as well as for high speed handpieces. The cleaning should be carried out at a minimum of 55°C (131°F) and for at least 5 minutes, the disinfection at a minimum of 90°C (194°F) and for at least 5 minutes (for an A0-value >...
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The sterilization was validated with the device Tuttnauer® EHS 3870 in a fractional pre-vacuum process at 134°C (273°F) for 5 minutes. Please note, that the reprocessing procedure performed in your dental office must be validated also. For more information on the entire preparation process download our MK-dent Processing Guide for High- & Low Speed Handpieces from our website www.mk-dent.com/downloadcenter.
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MK-dent is not liable for defects and their consequences that have arisen whose arising may be due to natural wear, improper handling, improper cleaning, or maintenance, non-compliance with operating or manual instructions, calcination or corrosion, contaminated air and water supply or chemical or electrical influences that are unusual or after MK-dent’s instruction for use or other manufacturer‘s instructions are not permitted.
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