Summit Medical TISSU-TRANS FILTRON 500cc Instructions D'utilisation

TISSU-TRANS FILTRON
®
Sterile Fat Collection and Filtration
3-TT-FILTRON 500, 1000 and 2000
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:
•
Universal Bracket on tall canister stand or IV pole clamp
•
Sterile mayo-stand drape or equivalent to cover canister stand
•
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 source.
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. Drape canister stand with sterile Mayo stand cover (or equivalent).
2. Remove sterile components and place on sterile surface. Remove and discard protective
packaging.
3. Secure FILTRON to canister stand by inserting mounting bracket on canister into
universal slots on stand - being careful to maintain sterility.
4. Connect standard suction tubing to the VAC port on the canister lid. Connect the other end to
waste canister and suction.
5. Connect L-Connector end of included harvest tubing to PATIENT port on the cannister lid.
Connect other end of tubing to cannula.
6. 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.
7. 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
500cc, 1000cc, and 2000cc
®
Filtron
Waste
Canister
The FILTRON is placed
inline between the
cannula handle and
waste canister.
Figure 1
Figure 2
500cc
Figure 3
←
Waste
Suction
Source
Suctioned
Out
Figure 4
Mounting
Bracket
2000cc
1000cc
Fat
Harvested
Quality Fat
Retained in Filter
←
VAC Port
Patient
Port
45890 | RevC | OCT2021