AquaShape LipoCollector™ Instructions for use
AquaShape LipoCollector™ Instructions for use
AquaShape LipoCollector™ Instructions for use
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Human Med AG<br />
<strong>Instructions</strong> <strong>for</strong> <strong>use</strong> and processing of the LipoCollector TM<br />
<strong>AquaShape</strong> ® LipoCollector<br />
<strong>Instructions</strong> <strong>for</strong> <strong>use</strong><br />
ISO 13485<br />
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Vers./Date:<br />
<strong>Instructions</strong> <strong>for</strong> <strong>AquaShape</strong> ® LipoCollector Item No. 650000<br />
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All rights reserved, particularly the right to reproduce and distribute as well as<br />
translate these instructions <strong>for</strong> <strong>use</strong>.<br />
No part of these instructions <strong>for</strong> <strong>use</strong> may be reproduced in any <strong>for</strong>m (by<br />
photocopying, microfilm or other procedures) or processed, copied or distributed<br />
using electronic systems without prior written consent of Human Med AG.<br />
The in<strong>for</strong>mation contained in these instructions is subject to change or update without prior notification<br />
and Human Med AG assumes no liability <strong>for</strong> the contents of the in<strong>for</strong>mation.<br />
Printed by: Human Med AG<br />
Printed in Germany<br />
Copyright © Human Med AG; Wilhelm-Hennemann-Straße 9, 19061 Schwerin; 2008
Human Med AG<br />
<strong>Instructions</strong> <strong>for</strong> <strong>use</strong> and processing of the LipoCollector TM<br />
Table of Contents<br />
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Page<br />
General description of the <strong>AquaShape</strong> ® LipoCollector 3<br />
Safety in<strong>for</strong>mation<br />
Explanation of the safety in<strong>for</strong>mation 3<br />
Explanation of the instructions <strong>for</strong> <strong>use</strong> and training of medical personnel 4<br />
Legal disclaimer, disposal 4<br />
Recommendations <strong>for</strong> delivery; assembly and processing 4<br />
Processing and assembly of the LipoCollector TM 5<br />
Preparation <strong>for</strong> <strong>use</strong> as a container to collect patient’s own fat 14<br />
<strong>Instructions</strong> <strong>for</strong> extraction of lipocytes 16<br />
Level of fluid above the filter<br />
Selection of filters; test run<br />
Ensure gradual pressure reduction<br />
Careful operation increases the quality of the aspirate<br />
Collected quantity / liquid fraction of the aspirate<br />
Removal of fat from the container<br />
Advice on initial processing after delivery: 18
Human Med AG<br />
<strong>Instructions</strong> <strong>for</strong> <strong>use</strong> and processing of the LipoCollector TM<br />
Description of the product<br />
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The LipoCollector TM collects the cell-liquid mixture suctioned off during liposuction using<br />
waterjet-assisted liposuction (WAL) and separates the fat from the remaining liquid, enabling<br />
the fat to be <strong>use</strong>d <strong>for</strong> lipostructure or non-invasive purposes.<br />
The LipoCollector TM serves to filter lipocytes and connective tissue from the aspirate which is<br />
extracted during waterjet-assisted liposuction. A special filter unit, comprising a stainless steel<br />
wire fabric with a mesh/hole size from 0.2 µm to 0.63 µm, captures the appropriate particles in a<br />
sterile collecting container so that only the WAL rinsing solution ends up in the waste<br />
containers provided.<br />
The multi-layered filter unit can be assembled by the surgeon as required using a combination of separate<br />
filters. This allows the consistency and particle size of the filtrate to be controlled.<br />
This type of lipocyte extraction represents a refinement and makes the procedure easier when<br />
extracting larger quantities.<br />
Safety in<strong>for</strong>mation<br />
Intended <strong>use</strong><br />
The LipoCollector TM is intended to be <strong>use</strong>d <strong>for</strong> lipocyte extraction during waterjet-assisted<br />
liposuction. The device can be <strong>use</strong>d in outpatient as well as inpatient surgeries.<br />
The prerequisite <strong>for</strong> optimal <strong>use</strong> of the product is functioning suction equipment (body-jet®,<br />
<strong>AquaShape</strong> ® mobile) suitable <strong>for</strong> WAL.<br />
Human Med AG does not guarantee the quality of the material collected with the<br />
LipoCollector TM and assumes no liability <strong>for</strong> any surgical procedures undertaken using the<br />
collected material or their results.<br />
Explanation of the safety in<strong>for</strong>mation<br />
WARNING! The safety in<strong>for</strong>mation WARNING! denotes a hazard that<br />
can ca<strong>use</strong> personal injury.<br />
CAUTION! The safety in<strong>for</strong>mation CAUTION! denotes a hazard that<br />
can ca<strong>use</strong> damage to property.<br />
ATTENTION! The safety in<strong>for</strong>mation ATTENTION! denotes a hazard that<br />
can ca<strong>use</strong> the device to malfunction.<br />
Please pay particular attention to the safety in<strong>for</strong>mation in each chapter.
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Explanation of the instructions <strong>for</strong> <strong>use</strong> and training of medical personnel<br />
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Who should read the instructions <strong>for</strong> <strong>use</strong>?<br />
An important component of the safety concept of the product is the instructions <strong>for</strong> <strong>use</strong>.<br />
There<strong>for</strong>e all those who will<br />
• prepare,<br />
• set up,<br />
• operate,<br />
• dismantle,<br />
• clean and disinfect<br />
the device and the instruments should read the instructions <strong>for</strong> <strong>use</strong> and usage recommendations.<br />
WARNING!<br />
The LipoCollector TM may only be <strong>use</strong>d by medical specialists trained in this procedure in<br />
compliance with the accompanying operating recommendations. Human Med AG assumes no<br />
liability <strong>for</strong> any damage resulting from improper <strong>use</strong>.<br />
ATTENTION! Be<strong>for</strong>e the first proper <strong>use</strong> a test run should be carried out with normal<br />
liposuction, <strong>for</strong> which the aspirate can be discarded, as the surgeon’s technique may also have<br />
an effect on the fat extraction and this may have to be adapted to optimise future results.<br />
Recommendations <strong>for</strong> delivery; assembly and processing<br />
The LipoCollector TM is supplied as a non-sterile product and must be assembled and processed<br />
prior to the first <strong>use</strong> according to the following recommendations.<br />
The recommendations <strong>for</strong> initial processing after delivery (from page 16) must also be<br />
followed.<br />
The instructions <strong>for</strong> processing and assembly of the LipoCollector TM (from page 5) are also<br />
applicable.<br />
Disposal<br />
The LipoCollector TM can be disposed of at the end of its life according to the valid EU<br />
guidelines <strong>for</strong> the disposal of medical waste.
Human Med AG<br />
<strong>Instructions</strong> <strong>for</strong> <strong>use</strong> and processing of the LipoCollector TM<br />
Processing and assembly of the LipoCollector TM<br />
Special Note:<br />
ATTENTION!<br />
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Plastics can be damaged by highly alkaline (pH > 10) cleaning and disinfecting<br />
agents.<br />
Only those cleaning agents should be <strong>use</strong>d which are recommended <strong>for</strong> the cleaning<br />
of plastics. Please refer to the manufacturer of the instrument cleaning or disinfecting<br />
agent.<br />
Do not <strong>use</strong> cleaning or disinfection agents that contain phenol.<br />
We recommend the <strong>use</strong> of a combined cleaning and disinfecting agent.<br />
Agents tested by us are listed on page 10.<br />
Validation was carried out with Gigasept Instru AF.<br />
Cleaning and sterilisation must be carried out only by trained personnel in designated<br />
rooms.<br />
Limit to re -<strong>use</strong>: The end of the product lifetime is usually determined by wear and tear resulting from<br />
<strong>use</strong>.<br />
All components of the LipoCollector TM have safely tested <strong>for</strong> 50 processing cycles.<br />
Any additional processing cycles become the responsibility of the <strong>use</strong>r.<br />
Necessary tools Ultrasound cleaning bath, rinsing bath, cleaning bath, cleaning brushes as follows<br />
<strong>Instructions</strong>:<br />
At location of <strong>use</strong>: Remove surface soiling with a disposable cloth / paper towel.<br />
Storage and transport: It is recommended to prepare the parts of the containers <strong>for</strong> the next <strong>use</strong> immediately<br />
after <strong>use</strong>.<br />
Dismantling and<br />
pre-cleaning:<br />
1.<br />
10 mm<br />
5 mm<br />
Remove the reducer (A) on the “PATIENT” connection from the lid of the container.<br />
A
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2. Remove the lid (A) from the collection container (B):<br />
B<br />
3. Pull the silicon hose out from the underside of the lid.<br />
A<br />
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4. The seal is made of single-<strong>use</strong> material and must be removed from the lid and<br />
disposed of.
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5. We recommend tapping against the edge of the container to loosen the container<br />
insert.<br />
The container insert can then be removed.<br />
6.<br />
7.<br />
The silicon hose is a single-<strong>use</strong> material<br />
and must be pulled out and disposed of.<br />
The inner workings (stainless steel retaining ring, fine filters and per<strong>for</strong>ated metal<br />
plates) must be pushed out.
Human Med AG<br />
<strong>Instructions</strong> <strong>for</strong> <strong>use</strong> and processing of the LipoCollector TM<br />
The parts are now as shown below:<br />
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8. The fine filters (A) are single-<strong>use</strong> material and must be disposed of.<br />
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9. All individual parts required <strong>for</strong> re-<strong>use</strong>, collection container, per<strong>for</strong>ated metal<br />
plate, container unit, lid, reducer and retaining ring, must be immersed in the<br />
cleaning and disinfecting solution (Gigasept Instru AF, 1.5%, made up with lukewarm<br />
water, demineralised water if possible) <strong>for</strong> at least 10 minutes or longer if necessary<br />
<strong>for</strong> stubborn or dried soiling.<br />
A<br />
10. Then the cavities must be cleaned out:<br />
Both tubes of the container<br />
insert must be cleaned<br />
with the 5 mm brush.
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The internal spaces in the lid must be cleaned with the 5 mm and the 10 mm brushes.<br />
11. The O-ring (A) must be removed from the reducer.<br />
A<br />
The reducer must then be cleaned with a 5 mm brush.
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12. All other surfaces must then be cleaned with the 10 mm brush.<br />
Pre-cleaning with the brushes must be carried out using the cleaning and disinfecting<br />
solution (Gigasept Instru AF, 1.5%, made up with lukewarm water, demineralised<br />
water if possible).<br />
These steps must be repeated until the brushes and the surfaces and cavities to be<br />
cleaned are free of visible contamination.<br />
The instrument cleaning solution must be renewed at least daily or if there is visible<br />
contamination.<br />
13. Cleaning and<br />
disinfection:<br />
ATTENTION!<br />
14. Drying:<br />
15. Maintenance:<br />
16. Packing:<br />
17. Sterilisation:<br />
18. Storage:<br />
All parts must now be completely immersed in an ultrasound bath with cleaning and<br />
disinfecting solution (Gigasept Instru AF, 3%, made up with lukewarm water,<br />
demineralised water if possible). The cleaning process in the ultrasound bath must be<br />
at least 5 minutes long.<br />
Cleaning <strong>for</strong> 15 minutes in an immersion bath is also possible. In this case the same<br />
cleaning solution and the same temperature are required.<br />
Do not mix with other cleaners.<br />
After cleaning in the solution the parts must be thoroughly rinsed with running water<br />
(preferably demineralised) or in a rinsing bath <strong>for</strong> at least 1 minute.<br />
Repeat rinse step again.<br />
Dry all parts inside and out with sterile compressed air.<br />
Maintenance of the individual parts is not intended.<br />
The dried individual parts of the LipoCollector TM must be packed as follows in<br />
suitable sterile packaging suitable <strong>for</strong> steam sterilisation as per ISO 11607. The<br />
package must be large enough that the seal is not under tension.<br />
1. Container insert separately<br />
2. Lid separately<br />
3. Retaining ring, per<strong>for</strong>ated metal plates and reducer together<br />
4. Collection container separately<br />
Steam sterilisation using a fractionated vacuum procedure at 121°C <strong>for</strong> at least 15<br />
minutes and at 134°C <strong>for</strong> 3 minutes is validated.<br />
Sterilisation at 134°C <strong>for</strong> at least 10 minutes was tested with no negative effects on<br />
the material detected.<br />
For every sterilisation check the pressure protocol <strong>for</strong> the particular steriliser to ensure<br />
compliance with the necessary parameters.<br />
The individual sterile foil bags must be stored in a closed cupboard protected from<br />
dust, moisture and large temperature fluctuations.<br />
The shelf life is determined by the specifications <strong>for</strong> the sterile packaging <strong>use</strong>d.
Human Med AG<br />
<strong>Instructions</strong> <strong>for</strong> <strong>use</strong> and processing of the LipoCollector TM<br />
19. Assembly prior to<br />
clinical <strong>use</strong><br />
Checking and testing:<br />
WARNING!<br />
ATTENTION!<br />
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Carry out a visual inspection <strong>for</strong> damage and wear. Assembly must not be carried out<br />
if there is visible damage to individual parts and Human Med AG must be in<strong>for</strong>med.<br />
The assembly of the complete LipoCollector TM must be carried out under sterile<br />
conditions using the supplied sterile single-<strong>use</strong> components (inner silicon hose, seals<br />
<strong>for</strong> the lid and reducer and fine filters).<br />
The assembly is done in the reverse order to the dismantling:<br />
The per<strong>for</strong>ated metal plate (A) is placed in the container insert (B).<br />
Then one or more new fine filters (C) are inserted.<br />
The retaining ring (D) is then placed on top.<br />
A<br />
B<br />
C<br />
A new seal is placed in the groove of the lid.<br />
A new silicon hose must be fitted onto the tube (A) of the container insert.<br />
A<br />
D
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The completed container insert must be fitted into the collection container.<br />
The other end of the silicon hose must be fitted onto the connection nozzle of the<br />
container lid.<br />
The lid with its seal must be fitted onto the collection container.
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The small O-ring (A) must be fitted onto the reducer.<br />
A<br />
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The completed reducer <strong>for</strong> the suction hose must then be fitted into the opening<br />
“PATIENT” on the lid.<br />
The container is now ready <strong>for</strong> <strong>use</strong>.<br />
The connecting hose <strong>for</strong> the suction device and the suction hose to the fat<br />
extraction cannula can be connected.
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Preparation <strong>for</strong> <strong>use</strong> as a container to collect patient’s own fat<br />
The end of the connecting hose Art. No. 653300 must be fitted onto the connector SUCTION<br />
CONTAINER (A).<br />
B<br />
A<br />
The suction hose <strong>for</strong> the cannula <strong>for</strong> fat extraction<br />
must be fitted onto the reducer PATIENT (C).<br />
The normal suction container of the body-jet ®<br />
– or the particular suction pump supplied with<br />
the <strong>AquaShape</strong> ® mobile – must be connected.<br />
To do this the funnel of the connecting hose<br />
must be fitted onto the patient connector of the<br />
normal suction container (B).<br />
The suction container must be connected to<br />
the particular suction device.<br />
C
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The instructions detailed above <strong>for</strong> re-<strong>use</strong> of the LipoCollector TM have been validated as suitable<br />
by Human Med AG.<br />
The person carrying out reprocessing is responsible <strong>for</strong> ensuring that the processing actually<br />
carried out with the equipment, material and personnel in the processing set-up achieves the<br />
desired results. For this purpose validation and routine monitoring of the procedure is usually<br />
necessary. Likewise any deviation from the instructions provided by the person carrying out<br />
reprocessing should be analysed carefully <strong>for</strong> its effect and possible adverse consequences.<br />
Table 1: List of instrument cleaning and disinfecting agents tested by Human Med AG <strong>for</strong><br />
material compatibility from the list of the Deutsche Gesellschaft für Hygiene und<br />
Mikrobiologie (DGHM, German Society of Hygiene and Microbiology)<br />
Marketing name Manufacturer Note<br />
Instrument cleaning<br />
SCHÜLKE &<br />
Thermosept RKN-zym<br />
MAYR<br />
Instrument disinfection<br />
neodisher Septo 3000 DR. WEIGERT<br />
Disinfecting cleaner<br />
SCHÜLKE &<br />
Gigasept Instru AF<br />
MAYR<br />
enzymatic cleaner<br />
aldehyde-free
Human Med AG<br />
<strong>Instructions</strong> <strong>for</strong> <strong>use</strong> and processing of the LipoCollector TM<br />
<strong>Instructions</strong> <strong>for</strong> extraction of lipocytes<br />
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ATTENTION: The following recommendations are based on <strong>use</strong>rs’ experience <strong>for</strong> other <strong>use</strong>rs.<br />
No guarantee can be given of successfully carrying out fat extraction during liposuction due to<br />
various biological and methodological factors.<br />
We are grateful <strong>for</strong> any in<strong>for</strong>mation that would improve these recommendations.<br />
Level of fluid above the filter<br />
The principle of the LipoCollector TM is that there is an initial separation of liquid and lipocytes<br />
due to the physical buoyancy. The less dense fat floats on the liquid which is concurrently and<br />
continuously suctioned off. In doing so the filter is constantly rinsed with liquid which prevents<br />
the filter mesh becoming blocked. Only near the end of lipocyte extraction, when the minimal<br />
remnant liquid beneath the fat mixture is being suctioned off, does the full function of the filter<br />
come into play.<br />
ATTENTION! In order to achieve optimal filtration there should always be liquid above the<br />
filter. There<strong>for</strong>e:<br />
• Fill the collection container be<strong>for</strong>e the liposuction with sterile isotonic saline up to the<br />
400 ml mark on the container scale.<br />
• Only switch the suction on when you begin with the liposuction itself (no ‘empty run’)<br />
• Do not shake or swing the LipoCollector TM .<br />
Selection of filters<br />
NOTE: The correct filter size depends on a variety of factors and must there<strong>for</strong>e first be roughly<br />
determined in a test run (see also safety in<strong>for</strong>mation, p. 4).<br />
In the test run a fine filter with a 250 µm mesh size should first be <strong>use</strong>d.<br />
Filtration is optimal when no significant amount of liquid backs up above the filter and<br />
simultaneously no lipocytes are sucked past the filter. A filter of the appropriate size is selected<br />
based on necessity.<br />
Ensure gradual pressure reduction<br />
During operation of the LipoCollector TM an abrupt reduction in pressure in the system should be<br />
avoided. If the system is opened on the patient's side, the atmospheric pressure ca<strong>use</strong>s a large<br />
drop in pressure, which can lead to knocking of the suction hose and powerful injection of the<br />
aspirate with great <strong>for</strong>ce, which can damage the filter mechanism.<br />
There<strong>for</strong>e please note the following points:<br />
• Release the bypass hole of the cannula slowly (rolling movement of the thumb)<br />
• Do not pull the cannula abruptly from the incision (with existing vacuum)<br />
• Only <strong>use</strong> the original reducer (connector “Patient” on the container lid)<br />
ATTENTION! If, during extraction of the patient's own fat, the fat suction is interrupted <strong>for</strong><br />
more than 15 seconds, switch off the suction pump or reduce the negative pressure to 0. If no<br />
liquid flows too much cell material can be suctioned off, causing blockage of the fine filters.
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<strong>Instructions</strong> <strong>for</strong> <strong>use</strong> and processing of the LipoCollector TM<br />
Careful operation increases the quality of the aspirate<br />
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The vacuum should only be as high as necessary to achieve a good suction result. The<br />
recommendation is max. -0.5 bar. On one hand this reduces excessive suction of the aspirate<br />
above and through the filter which can also ca<strong>use</strong> blockages. On the other hand the mechanical<br />
load on the lipocytes is reduced, which should also be advantageous <strong>for</strong> the quality of the<br />
lipocyte concentrate.<br />
To ensure trouble-free collection of the fat component of the aspirate it is advantageous to<br />
operate with steady cannula movements. The surgeon should 'allow the water to do the work'<br />
and not extract the fat by dissection using <strong>for</strong>ce on the suction opening of the cannula. The fat<br />
should rather be 'rinsed free' so that connective tissue components can be avoided in the aspirate<br />
as far as possible.<br />
It is recommended to work with a 3.5 mm cannula or 3.8 mm at the most so that loosened fat<br />
particles or cell islets remain as small as possible.<br />
The water pressure should generally be Range 2 or 3 (body-jet® and <strong>AquaShape</strong> ® mobile).<br />
Collected quantity / liquid fraction of the aspirate<br />
Filtration of the aspirate with the LipoCollector TM takes place – intentionally – almost<br />
exclusively using buoyancy and gravity, as the suction of the system during liposuction is<br />
directed through the bypass hole on the container insert adjacent to the previously collected<br />
aspirate. This means the lipocytes that have been suctioned off are treated as gently as possible.<br />
NOTE: Pay attention during liposuction to the level of liquid in the container. If the liquid/fat<br />
concentrate level in the container has reached the height of the bypass tube in the container, it<br />
can overflow, causing loss of subsequent incoming aspirate.<br />
The portion of liquid remaining in the aspirate after completely passing through is about 20%-<br />
25%, which is also necessary to be able to re-inject the fat later through thin cannulae if<br />
necessary. The means that centrifugation can generally be omitted.<br />
The quantity of collected fat-liquid mixture can be approximated using the scale on the side of<br />
the container. Subtract 200 ml from the value read from the scale (<strong>for</strong> the container volume<br />
beneath the filter unit and the volume of the insert). To calculate the quantity of solid<br />
components, a liquid fraction of about 20%-25% must be subtracted.<br />
Example calculation: Drain volume, read from container scale: 800 ml<br />
- 200 ml void volume<br />
= 600 ml fat-liquid mixture<br />
- 25% liquid fraction<br />
= approx. 450 ml fraction of solid components ('pure' fat)<br />
Removal of fat from the container<br />
Be<strong>for</strong>e removing fat from the LipoCollector TM the liquid fraction in the aspirate should be<br />
reduced by allowing the suction pump to run <strong>for</strong> a short time (approx. 2 minutes) after<br />
completion of the liposuction. The flow of the liquid can be easily seen through the transparent<br />
container.<br />
The filtered aspirate can also be withdrawn using a cannula while keeping the lid closed to avoid<br />
further contact with air as much as possible. To do this, the reducer is simply removed from the<br />
lid and the opening <strong>use</strong>d <strong>for</strong> removal of the aspirate.
Human Med AG<br />
<strong>Instructions</strong> <strong>for</strong> <strong>use</strong> and processing of the LipoCollector TM<br />
Advice on initial processing after delivery<br />
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The LipoCollector TM is supplied non-sterile and the individual pieces are disassembled.<br />
The sterile connecting hose is first removed and stored.<br />
The single-<strong>use</strong> articles Art. No. 650022 (seals and inner hose) are removed and stored.<br />
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Then the sterile articles Art. No. 651200, 651250, 651315, 651415, and 651630 (various fine<br />
filters) are removed and stored.
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The top of the inner package is then removed.<br />
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Now the non-sterile parts of the LipoCollector TM can be removed and set up <strong>for</strong> processing.<br />
These articles can then be readied <strong>for</strong><br />
processing.<br />
The lid is first removed and can be readied <strong>for</strong> processing,<br />
then the bubble wrap is removed from the collection<br />
container.<br />
The plastic bag with the reducer, 1 to 3 per<strong>for</strong>ated metal<br />
plates and the retaining ring can then be removed.
Human Med AG<br />
<strong>Instructions</strong> <strong>for</strong> <strong>use</strong> and processing of the LipoCollector TM<br />
The container insert is removed from the collection container.<br />
Page:<br />
Vers./Date:<br />
Now the collection container and the container insert can be readied <strong>for</strong> processing.<br />
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The LipoCollector TM must be cleaned and disinfected as shown in point 8 onwards of the<br />
processing instructions, except that no individual parts need to be separated.<br />
Then the parts are sterilised.<br />
Assembly is done using the sterile accessories provided.<br />
WARNING! Processing of the single-<strong>use</strong> parts is not authorised and can lead to un<strong>for</strong>eseeable<br />
risks <strong>for</strong> the patient.