INSTRUCTIONS FOR USE
c-tec CAPROTEC MONOFILAMENT
Sterile monofilament synthetic resorbable surgical suture made from a copolymer of glycolide and ε‑caprolactone
PRODUCT DESCRIPTION:
c-tec CAPROTEC is a sterile synthetic resorbable monofilament composed of a copolymer of glycolide and ε-caprolactone. The Suture is nonantigenic and noncollagenous. Sterile c-tec CAPROTEC is available in dyed D&C Violet No. 2 (Color Index Nr. 60725). The product elicits a minimal acute inflammatory reaction in tissues. Progressive loss of tensile strength and resorption of c-tec CAPROTEC occurs by hydrolysis, where the polymer degrades to adipic acid, which is subsequently absorbed and metabolized by the body. Resorption begins as a loss of tensile strength followed by a loss of mass. Implantation studies in animals indicate that sterile c-tec CAPROTEC retains approximately 60% of its original tensile strength at seven days post implantation, with approximately 30% remaining at 14 days post implantation. The resorption of sterile c-tec CAPROTEC is completed within 90 and 120 days.
INDICATION
c-tec CAPROTEC is designed for use in general soft tissue approximation and/or ligation where a resorbable material is indicated.
REACTION IN TISSUE
Slight initial inflammatory reaction in tissue.
CONTRAINDICATIONS
c-tec CAPROTEC should not be used in the tissues which may undergo expansion, stretching or distension 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 must remain in place longer than 7 days may cause local irritation and so the part of the suture, which is showing, should be snipped off or removed as indicated. Subcutaneous sutures should be placed as profound as possible to minimize the 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 apply surgical sutures.
ADVERSE REACTIONS
Adverse effects associated with the use of c-tec CAPROTEC include: transient local irritation at the wound site, transient inflammatory foreign body response, erythema and induration during resorption with subcuticular sutures. Like all foreign bodies c-tec CAPROTEC may potentiate an existing infection.
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 handling the producer guarantees the absolute quality of the product.
STERILIZATION
c-tec CAPROTEC is sterilized by ethylene oxide.
STORAGE
The sutures have to be stored in their original packaging in a clean, dry room at a temperature of
10° C to 25°C, protected from direct light or heat and all kinds of moisture. It should not be exposed to chemical influences.
SYMBOLS USED 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 CAPROTEC foil packs
|
|
USP 1
|
EP 4
|
|
12 x 1,5 m
|
|
USP 2
|
EP 5
|
|
12 x 1,5 m
|
|
c-tec CAPROTEC foil packs with needle
|
|
USP 5/0
|
EP 1
|
DS12 3/8 ▼
|
12 x 0,75 m
|
|
USP 4/0
|
EP 1,5
|
DS 15 3/8 ▼
|
12 x 0,75 m
|
|
USP 3/0
|
EP 2
|
DS 25 3/8 ▼
HR 22 1/2 ●
|
12 x 0,75 m
12 x 0,75 m
|
|
USP 2/0
|
EP 3
|
DS 25 3/8 ▼
HR 27 1/2 ●
|
12 x 0,75 m
12 x 0,75 m
|
|
USP 0
|
EP 3,5
|
DS 25 3/8 ▼
|
12 x 0,75 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- Caprotec –V1-2015