INSTRUCTIONS FOR USE
c-tec ALFATEC BRAIDED
Braided synthetic resorbable sterile coated surgical suture composed of polyglycolic acid.
PRODUCT DESCRIPTION
c-tec ALFATEC is a synthetic resorbable braided surgical suture composed of a polymer of glycolic acid. It is coated hydrophobically. The fibers are dyed purple with a FDA approved colour or undyed natural. The substances contained in the coating and suture are nonantigenic and noncollagenous. The product elicits a minimal acute inflammatory reaction in tissues. Progressive loss of tensile strength and resorption of c-tec ALFATEC occurs by hydrolysis, where the polymer degrades to glycolic acid, which is subsequently resorbed and metabolized by the body. Resorption begins as a loss of tensile strength without appreciable loss of mass. Implantation studies in animals indicate that sterile c-tec ALFATEC retains approximately 75 % of its original tensile strength at two weeks post implantation, with approximately 50 % remaining at three weeks. Resorption of c-tec ALFATEC is completed within 80–90 days.
INDICATION
c-tec ALFATEC is designed for use in general soft tissue approximation and/or ligation, for the surgical adaptation of muscles and fasciae, for suturing of parenchymal organs, peripheral nerves, for ligatures of small vessels and for intradermal suturing.
REACTION IN TISSUE
Slight inflammatory reaction in tissue.
CONTRA-INDICATIONS
c-tec ALFATEC should not be used in the tissues which may undergo expansion, which are under tension or which may require a long-term mechanical support.
WARNINGS
This suture may be inappropriate in elderly, malnourished or debilitated patients, or in patients whose bad conditions may delay wound healing. The use of supplemental non-resorbable sutures should be considered by the surgeon. Skin sutures, which are not removed after 7 days may cause local irritation and so the part of the suture, which is visible, should be snipped off and removed. Subcutaneous sutures should be placed as profound as possible to minimize erythema and induration that often accompany the resorption process. Prolonged contact of this suture (as any other foreign body) with salt solution, such as those found in urinary or biliary tracts, may result in calculus formation.
HANDLING INSTRUCTION
The material must not be damaged with instruments (needle holders, forceps,…). It shall be used by the surgeon's experience according to the usual surgical suturing methods.
Product is intended for single usage!
Do not use if package is opened or damaged!
Check the expiry date printed on the packing before use!
Do not use the product after the expiry date!
Do not resterilize!
Discard open and unused products!
Only trained staff (physicians, nurses, veterinarians,…) may handle surgical sutures.
HANDLING
Do not bend the bag with the suture. Take the bag out of the box and take it in both hands, open the bag by pulling the two loose ends of the package – without affecting the sterility of the surgical suture – so that the sterile inner support becomes visible, the latter may only be handled with sterile gloves . The inner support is torn open at the side, the suture can be taken out.
Sutures in atraumatic needles: after having opened the inner support, the needle becomes visible. Grasp the needle with the needle holder on its posterior side and pull it out of the bag. Make sure that the needle and thread do not come into contact with unsterile objects while pulling out. When removing the material from the bag, always use a needle holder.
The suture is sterile. Use the suture taken out of the bag immediately. Dispose remaining material into a separate waste container to prevent injuries of the medical staff. Upon correct and sterile handling, the producer guarantees absolute quality of the product.
STERILIZATION
c-tec ALFATEC is sterilized by ethylene oxide.
STORAGE
The sutures have to be stored in their original packaging in a clean, dry room at a temperature not above 25° C, protected from direct light or heat and all kinds of moisture. It should not be exposed to chemical influences.
SYMBOLS ON LABELING
Do not reuse/for single use only
Use by Month/year
Batch number
Sterilization by Ethylene Oxide. Sterile unless the package is damaged or opened.
Catalog number
Storage conditions
Attention, See Instructions for Use
CE mark and identification number of the notified body. Product conforms to the essential requirements of the Medical Device Directive 93/42/EEC.
CONDITIONING
| USP |
EP |
needle |
lenght(m) |
|
c-tec ALFATEC cassettes
|
|
USP 2
|
EP 5
|
|
50 m
|
|
USP 3+4
|
EP 6
|
|
50 m
|
|
c-tec ALFATEC foil packs
|
|
USP 2
|
EP 5
|
|
20 x 2,5 m
|
|
USP 3+4
|
EP 6
|
|
20 x 2,5 m
|
|
c-tec ALFATEC foil packs with needle
|
|
USP 5/0
|
EP 1
|
DS 12 3/8 ▼
HR 13 1/2 ●
|
3 x 0,7 m / 12 x 0,7 m
3 x 0,7 m / 12 x 0,7 m
|
|
USP 4/0
|
EP 1,5
|
DS 12 3/8 ▼
DS 25 3/8 ▼
HR 13 1/2 ●
|
3 x 0,7 m / 12 x 0,7 m
3 x 0,7 m / 12 x 0,7 m
3 x 0,7 m / 12 x 0,7 m
|
|
USP 3/0
|
EP 2
|
DS 25 3/8 ▼
|
12 x 0,7 m
|
|
USP 2/0
|
EP 3
|
DS 25 3/8 ▼
HS 40 1/2 ▼
|
12 x 0,7 m
12 x 0,7 m
|
|
USP 0
|
EP 3,5
|
DS 25 3/8 ▼
HS 40 1/2 ▼
|
12 x 0,7 m
12 x 0,7 m
|
|
USP 1
|
EP 4
|
DS 25 3/8 ▼
HS 40 1/2 ▼
|
12 x 0,7 m
12 x 0,7 m
|
|
USP 2
|
EP 5
|
HS 40 1/2 ▼
|
12 x 0,7 m
|
c-tec by Prodivet pharmaceuticals s.a./n.v.
Hagbenden 39c, 4731 B – Eynatten / BELGIUM
e-mail: info@prodivet.com
Tel: +32 (0) 87852025
mde emploi-GB- Alfatec-V2-2014