Summit Medical TISSU-TRANS FILTRON 100cc Instructions D'utilisation

TISSU-TRANS FILTRON
®
Sterile Fat Collection and Filtration
3-TT-FILTRON 100 and 250
Product is packaged in clear pouches and are provided sterile. DO NOT re-sterilize. Product part
number is provided on pouch label and indicates size.
Shelf Life
Use this product before the expiration date indicated on the label.
Intended Use
The Tissu-Trans Filtron is intended to be used with vacuum and/or cleared pumps, tubing and
® ®
cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may
be re-injected via a cleared injection apparatus.
Tissu-Trans Filtron is used in the aspiration, harvesting, filtering and transferring of autologous tissue.
Tissu-Trans Filtron is intended for use in the following surgical specialties when the aspiration of soft
tissue is desired:
• Plastic and Reconstructive Surgery
• Neurosurgery
• Gastrointestinal and Affiliated Organ Surgery
• Urological Surgery
• General Surgery
• Orthopedic Surgery
• Gynecological Surgery
• Thoracic Surgery
• Laparoscopic Surgery
Indication for Use
The Tissu-Trans Filtron is intended to be used with vacuum and/or cleared pumps, tubing and
cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated,
it may be re-injected via a cleared injection apparatus.
Sterile Items Included:
•
Harvest Canister with Filter and Waste Extraction Port
•
Harvest Tubing 6 feet
•
Transfer Tube 6 inches with Luer Lock tip
Standard Items Also Needed:
•
Standard suction tubing (1/4" or 5/16" ID)
•
Waste canister
•
Suction source (set at approx. 15" Hg. (380mm) or 50% power)
•
Cannula
•
Luer Lock syringes for transfer and re-injection
Notes before use:
1. The Tissu-Trans Filtron is sterile and disposable. One patient use.
Do Not Re-sterilize or Re-use.
2. Product is ready for use. Do not open canister or lid.
3. Be certain that the tissue is well hydrated — as in superwet tumescent anesthesia.
4. Must use a standard waste canister between the FILTRON and suction machine.
During harvest, waste is filtered out to waste canister.
5. Recommended to use a 3mm Harvest Cannula.
6. Recommended to use the medical grade tubing provided to assure non-toxic pathway.
7. Do not use if sterile pouch is torn or punctured.
8. If Filtron does not hold a vacuum, use a new device and call Customer Service.
Instructions:
1. Remove sterile components and place on sterile surface. Remove and discard protection
packaging.
2. Place FILTRON upright in sterile field. Must be kept vertical. A - See Figure 3.
3. Locate Harvest Tubing with L connector:
Connect L connector end of tubing to PATIENT Port on the canister lid. B - See Figure 4.
Connect other end of tubing to cannula.
4. Connect standard suction tubing to the VAC port on the canister lid. C - See Figure 4.
Connect the other end of tubing to waste canister and suction.
5. Turn on suction. Check all connections.
Adjust vacuum pressure to 15" or 380mm Hg. System may be tested with sterile saline to
ensure proper flow.
6. Harvest desired volume of fat. Quality fat will remain in filter and waste will be suctioned out to
waste canister. Fat remaining in filter will be ready for re-injection (if applicable).
Filtered fat may still have some liquid, which is necessary to ensure proper flow during transfer.
After fat is transferred to syringes, it may be decanted further and excess liquid expelled.
Instructions for Use
100cc and 250cc
®
Figure 1
Fat Harvested
Quality Fat
Retained in
Filter
Figure 2
Filtron
Waste
Cannister
Figure 3
A
Figure 4
Waste
Filtered and
Suctioned
Out
Suction Source
C
B
45885 | RevC | OCT2021