INSTRUCTIONS FOR USE
c-tec CELON MONOFILAMENT
Synthetic, sterile non-resorbable monofilament surgical suture composed of polyamide
PRODUCT DESCRIPTION
c-tec CELON is a synthetic monofilament suture composed of polyamide with a smooth surface. For better visibility during the operation, the filaments are dyed with a FDA approved non-irritating colour. The thread has good handling properties and a high tensile strength. c-tec CELON monofilament thread loses its mechanical strength after approximately 1 year in the tissue.
INDICATIONS
c-tec CELON is particularly suitable for plastic and general surgery and is often used in skin suture.
REACTION IN TISSUE
Slight inflammatory reaction in tissue.
CONTRA-INDICATIONS
c-tec CELON should not be used in the tissues which may require a long-term mechanical support.
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 CELON is sterilized by Gamma rays.
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, 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 irradiation. 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.
PACKAGING
| USP |
EP |
needle |
lenght (m) |
|
c-tec CELON foil packs with needle
|
|
USP 4/0
|
EP 1,5
|
DS 25 3/8 ▼
|
12 x 0,75 m
|
|
USP 3/0
|
EP 2
|
DS 25 3/8 ▼
|
12 x 0,75 m
12 x 0,45 m
|
|
USP 2/0
|
EP 3
|
DS 25 3/8 ▼
|
12 x 0,75 m
12 x 0,45 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- Celon-V2-2014