AquaShape LipoCollector™ Instructions for use

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Human Med AG Instructions for use and processing of the LipoCollector TM Table of Contents Page: Vers./Date: 2 of 20 1 / 15.07.2008 Page General description of the AquaShape ® LipoCollector 3 Safety information Explanation of the safety information 3 Explanation of the instructions for use and training of medical personnel 4 Legal disclaimer, disposal 4 Recommendations for delivery; assembly and processing 4 Processing and assembly of the LipoCollector TM 5 Preparation for use as a container to collect patient’s own fat 14 Instructions for extraction of lipocytes 16 Level of fluid above the filter Selection of filters; test run Ensure gradual pressure reduction Careful operation increases the quality of the aspirate Collected quantity / liquid fraction of the aspirate Removal of fat from the container Advice on initial processing after delivery: 18
Human Med AG Instructions for use and processing of the LipoCollector TM Description of the product Page: Vers./Date: 3 of 20 1 / 15.07.2008 The LipoCollector TM collects the cell-liquid mixture suctioned off during liposuction using waterjet-assisted liposuction (WAL) and separates the fat from the remaining liquid, enabling the fat to be used for lipostructure or non-invasive purposes. The LipoCollector TM serves to filter lipocytes and connective tissue from the aspirate which is extracted during waterjet-assisted liposuction. A special filter unit, comprising a stainless steel wire fabric with a mesh/hole size from 0.2 µm to 0.63 µm, captures the appropriate particles in a sterile collecting container so that only the WAL rinsing solution ends up in the waste containers provided. The multi-layered filter unit can be assembled by the surgeon as required using a combination of separate filters. This allows the consistency and particle size of the filtrate to be controlled. This type of lipocyte extraction represents a refinement and makes the procedure easier when extracting larger quantities. Safety information Intended use The LipoCollector TM is intended to be used for lipocyte extraction during waterjet-assisted liposuction. The device can be used in outpatient as well as inpatient surgeries. The prerequisite for optimal use of the product is functioning suction equipment (body-jet®, AquaShape ® mobile) suitable for WAL. Human Med AG does not guarantee the quality of the material collected with the LipoCollector TM and assumes no liability for any surgical procedures undertaken using the collected material or their results. Explanation of the safety information WARNING! The safety information WARNING! denotes a hazard that can cause personal injury. CAUTION! The safety information CAUTION! denotes a hazard that can cause damage to property. ATTENTION! The safety information ATTENTION! denotes a hazard that can cause the device to malfunction. Please pay particular attention to the safety information in each chapter.
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AquaShape LipoCollector™ Instructions for use

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