instructions for use - tecnología médica del caribe for use and processing of the lipocollector...

Human Med AG Instructions for use and processing of the LipoCollectorTM

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AquaShape® LipoCollector™

Instructions for use

ISO 13485 Instructions for AquaShape® LipoCollector™ Item No. 650000

All rights reserved, particularly the right to reproduce and distribute as well as translate these instructions for use. No part of these instructions for use may be reproduced in any form (by photocopying, microfilm or other procedures) or processed, copied or distributed using electronic systems without prior written consent of Human Med AG. The information contained in these instructions is subject to change or update without prior notification and Human Med AG assumes no liability for the contents of the information. Printed by: Human Med AG Printed in Germany Copyright © Human Med AG; Wilhelm-Hennemann-Straße 9, 19061 Schwerin; 2008


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Table of Contents 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 LipoCollectorTM 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


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Description of the product The LipoCollectorTM 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 LipoCollectorTM 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 LipoCollectorTM 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 LipoCollectorTM 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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Explanation of the instructions for use and training of medical personnel 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 LipoCollectorTM 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 LipoCollectorTM 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 LipoCollectorTM (from page 5) are also applicable. Disposal The LipoCollectorTM can be disposed of at the end of its life according to the valid EU guidelines for the disposal of medical waste.


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Processing and assembly of the LipoCollectorTM

Special Note:

ATTENTION!

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 LipoCollectorTM 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.

Remove the reducer (A) on the “PATIENT” connection from the lid of the container.

10 mm

5 mm

A


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2. Remove the lid (A) from the collection container (B):

3. Pull the silicon hose out from the underside of the lid.

4. The seal is made of single-use material and must be removed from the lid and disposed of.

A

B


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5. We recommend tapping against the edge of the container to loosen the container insert. The container insert can then be removed.

6. 7.

The silicon hose is a single-use material and must be pulled out and disposed of.

The inner workings (stainless steel retaining ring, fine filters and perforated metal plates) must be pushed out.


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The parts are now as shown below:

8. The fine filters (A) are single -use material and must be disposed of.

9. All individua l parts required for re-use, collection container, perforated metal plate, container unit, lid, reducer and retaining ring, must be immersed in the cleaning and disinfecting solution (Gigasept Instru AF, 1.5%, made up with lukewarm water, demineralised water if possible) for at least 10 minutes or longer if necessary for stubborn or dried soiling.

10. Then the cavities must be cleaned out:

Both tubes of the container insert must be cleaned with the 5 mm brush.

A


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The internal spaces in the lid must be cleaned with the 5 mm and the 10 mm brushes.

11. The O-ring (A) must be removed from the reducer. The reducer must then be cleaned with a 5 mm brush.

A


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12. All other surfaces must then be cleaned with the 10 mm brush. Pre-cleaning with the brushes must be carried out using the cleaning and disinfecting solution (Gigasept Instru AF, 1.5%, made up with lukewarm water, demineralised water if possible). These steps must be repeated until the brushes and the surfaces and cavities to be cleaned are free of visible contamination. The instrument cleaning solution must be renewed at least daily or if there is visible contamination.

13. Cleaning and disinfection:

ATTENTION!

All parts must now be completely immersed in an ultrasound bath with cleaning and disinfecting solution (Gigasept Instru AF, 3%, made up with lukewarm water, demineralised water if possible). The cleaning process in the ultrasound bath must be at least 5 minutes long. Cleaning for 15 minutes in an immersion bath is also possible. In this case the same cleaning solution and the same temperature are required. Do not mix with other cleaners. After cleaning in the solution the parts must be thoroughly rinsed with running water (preferably demineralised) or in a rinsing bath for at least 1 minute. Repeat rinse step again.

14. Drying:

Dry all parts inside and out with sterile compressed air.

15. Maintenance:

Maintenance of the individual parts is not intended.

16. Packing:

The dried individual parts of the LipoCollectorTM must be packed as follows in suitable sterile packaging suitable for steam sterilisation as per ISO 11607. The package must be large enough that the seal is not under tension. 1. Container insert separately 2. Lid separately 3. Retaining ring, perforated metal plates and reducer together 4. Collection container separately

17. Sterilisation:

Steam sterilisation using a fractionated vacuum procedure at 121°C for at least 15 minutes and at 134°C for 3 minutes is validated. Sterilisation at 134°C for at least 10 minutes was tested with no negative effects on the material detected.

For every sterilisation check the pressure protocol for the particular steriliser to ensure compliance with the necessary parameters.

18. Storage:

The individual sterile foil bags must be stored in a closed cupboard protected from dust, moisture and large temperature fluctuations. The shelf life is determined by the specifications for the sterile packaging used.


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19. Assembly prior to clinical use Checking and testing:

WARNING!

ATTENTION!

Carry out a visual inspection for damage and wear. Assembly must not be carried out if there is visible damage to individual parts and Human Med AG must be informed. The assembly of the complete LipoCollectorTM must be carried out under sterile conditions using the supplied sterile single -use components (inner silicon hose, seals for the lid and reducer and fine filters).

The assembly is done in the reverse order to the dismantling:

The perforated metal plate (A) is placed in the container insert (B). Then one or more new fine filters (C) are inserted.

The retaining ring (D) is then placed on top.

A new seal is placed in the groove of the lid.

A new silicon hose must be fitted onto the tube (A) of the container insert.

C A

B D

A


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The completed container insert must be fitted into the collection container.

The other end of the silicon hose must be fitted onto the connection nozzle of the container lid.

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.

The completed reducer for the suction hose must then be fitted into the opening “PATIENT” on the lid.

The container is now ready for use.

The connecting hose for the suction device and the suction hose to the fat extraction cannula can be connected.

A


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Preparation for use as a container to collect patient’s own fat

The end of the connecting hose Art. No. 653300 must be fitted onto the connector SUCTION CONTAINER (A).

The normal suction container of the body-jet® – or the particular suction pump supplied with the AquaShape® mobile – must be connected.

To do this the funnel of the connecting hose must be fitted onto the patient connector of the normal suction container (B).

The suction container must be connected to the particular suction device.

The suction hose for the cannula for fat extraction must be fitted onto the reducer PATIENT (C).

A B

C


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The instructions detailed above for re-use of the LipoCollectorTM have been validated as suitable by Human Med AG. The person carrying out reprocessing is responsible for ensuring that the processing actually carried out with the equipment, material and personnel in the processing set-up achieves the desired results. For this purpose validation and routine monitoring of the procedure is usually necessary. Likewise any deviation from the instructions provided by the person carrying out reprocessing should be analysed carefully for its effect and possible adverse consequences.

Table 1: List of instrument cleaning and disinfecting agents tested by Human Med AG for material compatibility from the list of the Deutsche Gesellschaft für Hygiene und Mikrobiologie (DGHM, German Society of Hygiene and Microbiology) Marketing name Manufacturer Note

Instrument cleaning

Thermosept RKN-zym SCHÜLKE & MAYR

enzymatic cleaner

Instrument disinfection

neodisher Septo 3000 DR. WEIGERT Disinfecting cleaner

Gigasept Instru AF SCHÜLKE & MAYR

aldehyde-free


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Instructions for extraction of lipocytes

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 LipoCollectorTM 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 LipoCollectorTM.

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 LipoCollectorTM 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.


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Careful operation increases the quality of the aspirate

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 LipoCollectorTM 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 LipoCollectorTM 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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Advice on initial processing after delivery The LipoCollectorTM is supplied non-sterile and the individual pieces are disassembled. The sterile connecting hose is first removed and stored.

The single-use articles Art. No. 650022 (seals and inner hose) are removed and stored.

Then the sterile articles Art. No. 651200, 651250, 651315, 651415, and 651630 (various fine filters) are removed and stored.


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The top of the inner package is then removed.

Now the non-sterile parts of the LipoCollectorTM can be removed and set up for processing.

The lid is first removed and can be readied for processing, then the bubble wrap is removed from the collection container. The plastic bag with the reducer, 1 to 3 perforated metal plates and the retaining ring can then be removed.

These articles can then be readied for processing.


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The container insert is removed from the collection container.

Now the collection container and the container insert can be readied for processing.

The LipoCollectorTM must be cleaned and disinfected as shown in point 8 onwards of the processing instructions, except that no individual parts need to be separated. Then the parts are sterilised. Assembly is done using the sterile accessories provided. WARNING! Processing of the single-use parts is not authorised and can lead to unforeseeable risks for the patient.

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