AquaShape LipoCollector™ Instructions for use

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Human Med AG Instructions for use and processing of the LipoCollector TM Page: Vers./Date: Explanation of the instructions for use and training of medical personnel 4 of 20 1 / 15.07.2008 Who should read the instructions for use? An important component of the safety concept of the product is the instructions for use. Therefore all those who will • prepare, • set up, • operate, • dismantle, • clean and disinfect the device and the instruments should read the instructions for use and usage recommendations. WARNING! The LipoCollector TM may only be used by medical specialists trained in this procedure in compliance with the accompanying operating recommendations. Human Med AG assumes no liability for any damage resulting from improper use. ATTENTION! Before the first proper use a test run should be carried out with normal liposuction, for which the aspirate can be discarded, as the surgeon’s technique may also have an effect on the fat extraction and this may have to be adapted to optimise future results. Recommendations for delivery; assembly and processing The LipoCollector TM is supplied as a non-sterile product and must be assembled and processed prior to the first use according to the following recommendations. The recommendations for initial processing after delivery (from page 16) must also be followed. The instructions for processing and assembly of the LipoCollector TM (from page 5) are also applicable. Disposal The LipoCollector TM can be disposed of at the end of its life according to the valid EU guidelines for the disposal of medical waste.
Human Med AG Instructions for use and processing of the LipoCollector TM Processing and assembly of the LipoCollector TM Special Note: ATTENTION! Page: Vers./Date: 5 of 20 1 / 15.07.2008 Plastics can be damaged by highly alkaline (pH > 10) cleaning and disinfecting agents. Only those cleaning agents should be used which are recommended for the cleaning of plastics. Please refer to the manufacturer of the instrument cleaning or disinfecting agent. Do not use cleaning or disinfection agents that contain phenol. We recommend the use of a combined cleaning and disinfecting agent. Agents tested by us are listed on page 10. Validation was carried out with Gigasept Instru AF. Cleaning and sterilisation must be carried out only by trained personnel in designated rooms. Limit to re -use: The end of the product lifetime is usually determined by wear and tear resulting from use. All components of the LipoCollector TM have safely tested for 50 processing cycles. Any additional processing cycles become the responsibility of the user. Necessary tools Ultrasound cleaning bath, rinsing bath, cleaning bath, cleaning brushes as follows Instructions: At location of use: Remove surface soiling with a disposable cloth / paper towel. Storage and transport: It is recommended to prepare the parts of the containers for the next use immediately after use. Dismantling and pre-cleaning: 1. 10 mm 5 mm Remove the reducer (A) on the “PATIENT” connection from the lid of the container. A
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AquaShape LipoCollector™ Instructions for use

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