INSTRUCTIONS FOR USE
c-tec CYNADOX MONOFILAMENT
Sterile monofilament synthetic resorbable surgical suture composed of the polyester poly p-dioxanone
PRODUCT DESCRIPTION
c-tec CYNADOX is a sterile monofilament synthetic resorbable surgical suture made from the polyester poly p-dioxanone. Poly p-dioxanone polymer has been found to be non-antigenic, non-pyrogenic and elicits a minimal acute inflammatory reaction in tissues. Progressive loss of tensile strength and resorption of c-tec CYNADOX occurs by hydrolysis, where the polymer degrades to the 2-hydroxyethoacetic 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 poly (p-dioxanone) suture retains approximately 50 % of its original tensile strength at six weeks post implantation. The resorption of sterile suture is completed between 180 and 210 days.
INDICATION
c-tec CYNADOX is designed for use in general soft tissue approximation and/or ligation, including use in paediatric cardiovascular tissue and in ophtalmic surgery. These sutures are particularly suitable where a resorbable thread as well as a wound support extended over a longer period (up to six weeks) are desirable (fasciae, orthopedics, vascular anastomosis). c-tec CYNADOX can be used in almost all areas of surgery.
REACTION IN TISSUE
Slight inflammatory reaction in tissue.
CONTRAINDICATIONS
c-tec CYNADOX should not be used where prolonged approximation of tissues under stress is required or for implantation of prosthesis (for example, heart valves or synthetic grafts).
WARNINGS
The safety and effectiveness of c-tec CYNADOX sutures have not been established in contact with the central nervous system, in adult cardiac tissue or in large vessels 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. Cutaneous and vaginal epithelium sutures which are not removed after 10 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.
Users should be familiar with surgical procedures and techniques involving resorbable sutures for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used. Acceptable surgical practice should be followed for the management of contaminated or infected wounds. Consideration should be taken in the use of resorbable sutures in tissues with poor blood supply as suture extrusion and delayed resorption may occur.
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 re-sterilize!
Discard open and unused products!
Only trained staff (physicians, nurses, veterinarians,…) may handle surgical sutures.
ADVERSE REACTIONS
Adverse reactions associated with the use of c-tec CYNADOX include: transient local irritation at the wound site, transient inflammatory tissue reaction on the applied foreign body and erythema and induration during resorption of intracutaneous sutures. Like all foreign bodies c-tec CYNADOX 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 and sterile handling, the producer guarantees absolute quality of the product.
STERILIZATION
c-tec CYNADOX 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 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 CYNADOX cassettes
|
|
USP 1
|
EP 4
|
|
50 m
|
|
USP 2
|
EP 5
|
|
50 m
|
|
c-tec CYNADOX foil packs with needle
|
|
USP 5/0
|
EP 1
|
DS12 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 15 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 3/0
|
EP 2
|
DS 25 3/8 ▼
HR 27 1/2 ●
|
12 x 0,7 m
12 x 0,7 m
|
|
USP 2/0
|
EP 3
|
DS 25 3/8 ▼
HR 27 1/2 ●
|
12 x 0,7 m
12 x 0,7 m
|
|
USP 0
|
EP 3,5
|
DS 25 3/8 ▼
HR 30 1/2 ●
|
12 x 0,7 m
12 x 0,7 m
|
|
USP 1
|
EP 4
|
HRX 40 1/2 ●
|
12 x 0,7 m
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- Cynadox-V2-2014