AquaShape LipoCollector™ Instructions for use

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Human Med AG Instructions for use and processing of the LipoCollector TM Instructions for extraction of lipocytes Page: Vers./Date: 16 of 20 1 / 15.07.2008 ATTENTION: The following recommendations are based on users’ experience for other users. No guarantee can be given of successfully carrying out fat extraction during liposuction due to various biological and methodological factors. We are grateful for any information that would improve these recommendations. Level of fluid above the filter The principle of the LipoCollector TM is that there is an initial separation of liquid and lipocytes due to the physical buoyancy. The less dense fat floats on the liquid which is concurrently and continuously suctioned off. In doing so the filter is constantly rinsed with liquid which prevents the filter mesh becoming blocked. Only near the end of lipocyte extraction, when the minimal remnant liquid beneath the fat mixture is being suctioned off, does the full function of the filter come into play. ATTENTION! In order to achieve optimal filtration there should always be liquid above the filter. Therefore: • Fill the collection container before the liposuction with sterile isotonic saline up to the 400 ml mark on the container scale. • Only switch the suction on when you begin with the liposuction itself (no ‘empty run’) • Do not shake or swing the LipoCollector TM . Selection of filters NOTE: The correct filter size depends on a variety of factors and must therefore first be roughly determined in a test run (see also safety information, p. 4). In the test run a fine filter with a 250 µm mesh size should first be used. Filtration is optimal when no significant amount of liquid backs up above the filter and simultaneously no lipocytes are sucked past the filter. A filter of the appropriate size is selected based on necessity. Ensure gradual pressure reduction During operation of the LipoCollector TM an abrupt reduction in pressure in the system should be avoided. If the system is opened on the patient's side, the atmospheric pressure causes a large drop in pressure, which can lead to knocking of the suction hose and powerful injection of the aspirate with great force, which can damage the filter mechanism. Therefore please note the following points: • Release the bypass hole of the cannula slowly (rolling movement of the thumb) • Do not pull the cannula abruptly from the incision (with existing vacuum) • Only use the original reducer (connector “Patient” on the container lid) ATTENTION! If, during extraction of the patient's own fat, the fat suction is interrupted for more than 15 seconds, switch off the suction pump or reduce the negative pressure to 0. If no liquid flows too much cell material can be suctioned off, causing blockage of the fine filters.
Human Med AG Instructions for use and processing of the LipoCollector TM Careful operation increases the quality of the aspirate Page: Vers./Date: 17 of 20 1 / 15.07.2008 The vacuum should only be as high as necessary to achieve a good suction result. The recommendation is max. -0.5 bar. On one hand this reduces excessive suction of the aspirate above and through the filter which can also cause blockages. On the other hand the mechanical load on the lipocytes is reduced, which should also be advantageous for the quality of the lipocyte concentrate. To ensure trouble-free collection of the fat component of the aspirate it is advantageous to operate with steady cannula movements. The surgeon should 'allow the water to do the work' and not extract the fat by dissection using force on the suction opening of the cannula. The fat should rather be 'rinsed free' so that connective tissue components can be avoided in the aspirate as far as possible. It is recommended to work with a 3.5 mm cannula or 3.8 mm at the most so that loosened fat particles or cell islets remain as small as possible. The water pressure should generally be Range 2 or 3 (body-jet® and AquaShape ® mobile). Collected quantity / liquid fraction of the aspirate Filtration of the aspirate with the LipoCollector TM takes place – intentionally – almost exclusively using buoyancy and gravity, as the suction of the system during liposuction is directed through the bypass hole on the container insert adjacent to the previously collected aspirate. This means the lipocytes that have been suctioned off are treated as gently as possible. NOTE: Pay attention during liposuction to the level of liquid in the container. If the liquid/fat concentrate level in the container has reached the height of the bypass tube in the container, it can overflow, causing loss of subsequent incoming aspirate. The portion of liquid remaining in the aspirate after completely passing through is about 20%- 25%, which is also necessary to be able to re-inject the fat later through thin cannulae if necessary. The means that centrifugation can generally be omitted. The quantity of collected fat-liquid mixture can be approximated using the scale on the side of the container. Subtract 200 ml from the value read from the scale (for the container volume beneath the filter unit and the volume of the insert). To calculate the quantity of solid components, a liquid fraction of about 20%-25% must be subtracted. Example calculation: Drain volume, read from container scale: 800 ml - 200 ml void volume = 600 ml fat-liquid mixture - 25% liquid fraction = approx. 450 ml fraction of solid components ('pure' fat) Removal of fat from the container Before removing fat from the LipoCollector TM the liquid fraction in the aspirate should be reduced by allowing the suction pump to run for a short time (approx. 2 minutes) after completion of the liposuction. The flow of the liquid can be easily seen through the transparent container. The filtered aspirate can also be withdrawn using a cannula while keeping the lid closed to avoid further contact with air as much as possible. To do this, the reducer is simply removed from the lid and the opening used for removal of the aspirate.
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AquaShape LipoCollector™ Instructions for use

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