Gima ETHICON VICRYL PLUS ABSORBABLE SUTURES User guide

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PPE Specification
Labeling Specification
8752635 Vicryl Plus CE-Marked IFU
c/o European Logistics Centre Leonardo Da Vincilaan, 15 BE-1831 Diegem Belgium 1-877-ETHICON +1-513-337-6928
ro FIR DE SUTURĂ
ru ШОВНЫЙ МАТЕРИАЛ
PLUS
SUTURE
VARRÓANYAG
KONAC
hr
hu
– ANTIBACTERIAL –
Coated VICRYL
КОНЕЦ
ŠICÍ MATERIÁL
cs
bg
8752635
CHIRURGICKÁ NIŤ
KIRURŠKA NITsrKONAC
sl
sk
SUTURA
봉합사
it
ko
SUTUR
NAHTMATERIAL
de
da
08/2019 LAB0012862v7
SIŪLAS
lt
PAMMA
el
SUTUR
ĶIRURĢISKAIS DIEGS
en SUTURE
SÜTÜR
缝线
tr
sv
zh-cn
HECHTDRAAD
SUTUR
lv
nl
no
et ÕMBLUSMATERJAL
es SUTURA
縫合線
zh-tw
NICI
pt FIO DE SUTURA
pl
OMMELAINEfrFIL DE SUTURE
enInstructions for use
Coated VICRYL™ PLUS ANTIBACTERIAL
(POLYGLACTIN 910)
STERILE SYNTHETIC ABSORBABLE
DESCRIPTION
Coated VICRYL™PLUS Antibacterial suture is a synthetic absorbable sterile surgical suture composed of a copolymer made from 90 % glycolide and 10 % L-lactide. The empirical formula of the copolymer is (C2H2O2)m(C3H4O2)n. Braided Coated VICRYL™PLUS Antibacterial sutures are coated with a mixture composed of equal parts of copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. Polyglactin 910 copolymer and Polyglactin 370 with calcium stearate have been found to be nonantigenic, nonpyrogenic and elicit only a slight tissue reaction during absorption. Coated VICRYL™PLUS Antibacterial suture contains Irgacare®‡ MP (Triclosan), a broad spectrum antibacterial agent at no more than 275 µg/m. Coated VICRYL™PLUS Antibacterial sutures are dyed by adding D+C violet # 2 (Color Index number: 60725) during polymerization. Sutures are also available in the undyed form. Coated VICRYL™PLUS Antibacterial sutures are available in a range of gauge sizes and lengths, non-needled or attached to stainless steel needles of varying types and sizes. The needles may be attached permanently or as CR-needles (control release), enabling the needles to be pulled o instead of being cut o. Full details are contained in the catalogue. Coated VICRYL™PLUS Antibacterial sutures comply with the requirements of the United States Pharmacopoeia for Absorbable Surgical Suture and the European Phar­macopoeia for Sterile Synthetic Absorbable Braided Sutures (except for an occasional slight oversize in some gauges).
INDICATIONS
Coated VICRYL™PLUS Antibacterial sutures are intended for use in general soft tissue approximation and/or ligation. The safety and eectiveness of Coated VICRYL™ PLUS Antibacterial sutures in cardiovascular tissue, ophthalmic surgery and neurological tissue have not been established.
APPLICATION
Sutures should be selected and implanted depending on patient condition, surgical experience, surgical technique and wound size.
PERFORMANCE
Coated VICRYL™PLUS Antibacterial suture elicits a minimal initial inammatory reac­tion in tissues and ingrowth of brous connective tissue. Progressive loss of tensile strength and eventual absorption of Coated VICRYL™PLUS Antibacterial sutures occurs by means of hydrolysis, where the copolymer degrades to glycolic and lactic acids which are subsequently absorbed and metabolized in the body. Absorption begins as a loss of tensile strength followed by a loss of mass. All of the original tensile strength is lost by five weeks post implantation. Absorption of Coated VICRYL™PLUS Antibacterial suture is essentially complete between 56 and 70 days.
SUTURE
Days Approximate % Original Implantation Strength Remaining
14 days 75% 21 days 50% 28 days 25% Coated VICRYL™PLUS Antibacterial suture has been shown to inhibit colonization of the suture by Staphylococcus aureus, Staphylococcus epidermidis and their Methicillin resistant strains. The clinical signicance of this nding is unknown.
CONTRAINDICATIONS
These sutures, being absorbable should not be used where extended approximation of tissues under stress is required. Coated VICRYL™PLUS Antibacterial suture should not be used in patients with known allergic reactions to Irgacare® MP (Triclosan).
WARNINGS/PRECAUTIONS/INTERACTIONS
Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing Coated VICRYL™ PLUS Antibacterial suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used. Surgeons should consider the in vivo performance (under PERFORMANCE section) when selecting a suture. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation. As an absorbable suture Coated VICRYL™PLUS Antibacterial suture may act transiently as a foreign body. Acceptable surgical practice should be followed for the management of contaminated or infected wounds. The use of Coated VICRYL™PLUS Antibacterial suture does not substitute normal observance of hygiene and/or otherwise needed antibiotic treatment. As this is an absorbable suture material, the use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of the sites which may undergo expansion, stretching or distension, or which may require additional support. Skin sutures which must remain in place longer than 7 days may cause localised irrita­tion and should be snipped o or removed as indicated. Under some circumstances, notably orthopaedic procedures, immobilisation of joints by external support may be employed at the discretion of the surgeon. Consideration should be taken in the use of absorbable sutures in tissues with poor blood supply as suture extrusion and delayed absorption may occur. Subcuticular sutures should be placed as deeply as possible to minimize the erythema and indura­tion normally associated with the absorption process. This suture may be inappropriate in elderly, malnourished or debilitated patients, or in patients suering from conditions which may delay wound healing. When handling this or any other suture material, care should be taken to avoid damage. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. Care should be taken to avoid damage when handling surgical needles. Grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point. Grasping in the point area could impair the penetration performance and cause fracture of the needle. Grasping at the butt or attachment end could cause
bending or breakage. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking. Users should exercise caution when handling surgical needles to avoid inadvertent needle stick injury. Discard used needles in ’Sharps’ containers. Adequate knot security requires the standard surgical technique of at and square ties with additional throws as indicated by surgical circumstances and the experience of the surgeon. Do not resterilize/reuse. Reuse of this device (or portions of this device) may create a risk of product degradation and cross-contamination, which may lead to infection or transmission of bloodborne pathogens to patients and users.
ADVERSE REACTIONS
Adverse reactions associated with the use of this device include transitory local irritation at the wound site, transitory inflammatory foreign body re­sponse, erythema and induration during the absorption process of subcu­ticular sutures. Like all foreign bodies Coated VICRYL™PLUS Antibacterial suture may potentiate an existing infection.
STERILITY
Coated VICRYL™PLUS Antibacterial sutures are sterilized by ethylene oxide gas. Do not resterilize. Do not use if package is opened or damaged. Discard opened, unused sutures.
STORAGE
Recommended storage conditions: Store at or below 25°C. Do not use after expiry date.
SYMBOLS USED ON LABELING
Do not reuse Use by – year and
Sterile unless package is damaged or opened. Method of sterilization: Ethylene Oxide
CE-mark and Identication Number of Notied Body. The product meets the essential requirements of Medical Device Directive 93/42/EEC
Upper limit of temperature Batch number
Caution: See instructions for use
‡ = Registered Trademark of BASF Group
month Manufacturer
Sachets
Catalogue Number
LAB-0012862 | Rev:7
Released: 29 Oct 2019
CO: 100749100
Release Level: 4. Production
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Folded Size
PPE Specification
Labeling Specification
8752635 Vicryl Plus CE-Marked IFU
LAB-0012862 | Rev:7
Released: 29 Oct 2019
CO: 100749100
Release Level: 4. Production
IFU PRINTING SPECIFICATION SHEET
PAGE LAYOUT
27.56" (700 mm)
Flat Size
BC FC
17.01"
(432 mm)
BC FC
BC FC
FOLD PATTERN
BC FC
FC
2.30" (58.33 mm)
4.25"
(108 mm)
TITLE DESCRIPTION LAB NUMBER SPECIAL INSTRUCTIONS/COMMENTS BINDING COLORS
VICRYL™ PLUS Map IFU LAB0012862v7
FLAT SIZE FOLDED SIZE RMC NUMBER PAGE COUNT LANGUAGES
27.56" x 17.01" 700 mm x 432 mm
BLEED SIZE .5" (12.7 mm) .125" (3.175 mm) NONE BLEED ALL SIDES BLEED TOP BLEED RIGHT BLEED LEFT BLEED BOTTOM
STOCK
2
45 g/m
2.30" x 4.25"
58.33 mm x 108 mm
X X X
8752635
2 bg, cs, da, de, el, en, es, et, , fr, hr, hu, it, ko, lt, lv, nl, no, pl, pt, ro, ru, sk, sl, sr, sv,
See Norderstedt RMS VPP833AUE and VPP833A for Tolerance and packaging requirements.
tr, zh-cn, zh-tw
DRAWING IS NOT TO SCALE: DRAWINGS REFLECT INFORMATION FOR PRODUCTION OF PRINTED PIECES AND DO NOT CONTAIN ACTUAL ARTWORK.
This document or data herein or herewith is not to be reproduced, used or disclosed in whole or part without the permission of Ethicon, Inc.
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SELF COVER PLUS COVER SEALING METHOD WAFER SEAL
X N/A
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