GIMA Trusilk IFU Non Absorbable Surgical Sture U.P.S User Manual
- June 9, 2024
- GIMA
Table of Contents
GIMA Trusilk IFU Non Absorbable Surgical Sture U.P.S
Gima S.p.A.
Via Marconi, 1 – 20060 Gessate (Ml) Italy
gima@gimaitaly.com –
export@gimaitaly.com
NON-ABSORBABLE SURGICAL SUTURE U.S.P (BLACK BRAIDED SILK)
DESCRIPTION
Trusilk is a nonabsorbable, sterile, surgical suture, composed of an organic protein, called fibroin. This protein is derived from the domesticated species Bombyx mori (B mori) of the family Bombycidae. Natural Silk contains approximately 30% extraneous material or gum which is removed by specially developed “Degumming” process. This process is essential for a compact braid while ensuring that the filaments retain their natural body and elasticity. Trusilk dyed with black Hematoxylin and coated with wax/ silicon. Trusilk meets all the requirements as per United States Pharmacopeia for Nonabsorbable Surgical suture.
INTENDED PURPOSE
Trusilk is indicated for use in soft tissue approximation and or ligation, including use in cardiovascular, ophthalmic and neurological tissues.
ACTION
Trusilk elicits an initial inflammatory reaction in tissues which is followed
by gradual encapsulation of the suture by fibrous connective tissue. While
Trusilk is not absorbed, progressive degradation of the proteinous silk fibres
in vivo may result in gradual loss of the sutures over a period of time.
CONTRA INDICATIONS
Use of this suture is contra indicated in patients with known sensitivities or
allergies to Silk. Due to the gradual loss of tensile strength which may occur
over prolonged periods in vivo, Trusilk sutures should not be used where
permanent retention of tensile strength is required as in fixation of vascular
prostheses.
WARNINGS
Do not reuse. Discard open, unused sutures. Prolonged contact of this suture
or any other suture with salt solutions such as those found in urinary and
biliary tracts, may result in calculus formation. Users should be familiar
with surgical procedures and techniques involving nonabsorbable sutures before
employing Trusilk for wound closures, as risk of wound dehiscence may vary
with the site of application and the suture material used. As any foreign
material in the presence of bacterial contamination may enhance bacterial
infectivity, acceptable surgical practice must be followed with respect to
drainage and closure of infected or contaminated wounds.
PRECAUTIONS
In handling this suture or any other suture material care should be taken to
avoid damage from handling. Avoid crushing or crimping damage due to
application of surgical instruments such as forceps or needle holders. As with
any suture material, adequate knot security requires the accepted surgical
techniques of flat and square ties, with additional throws as warranted by
surgical circumstances and the experience of the surgeon. Discard used needles
in ‘Sharps’ containers.
ADVERSE REACTIONS
Adverse reactions associated with the use of the device, Trusilk include wound
dehiscence, gradual loss of all tensile strength over time, allergic response
in patients who are known to be sensitive to silk, calculi formation in
urinary & biliary tracts when prolonged contact with salt solutions such as
urine and bile juice, enhanced bacterial infectivity, acute inflammatory
tissue reaction, pain, edema and erythema at the wound site.
SUPPLY
Trusilk is available in various U.S.P. sizes, The suture is supplied sterile
in pre-cut lengths, both non- needled and attached to various needle type,
shape and length. which are packed in a printed box quantity as indicated on
the box label. Non sterile reels are packed in 25 metres, six reels packed in
a box.
STORAGE
Recommended storage conditions: Below 30°C away from moisture and di-
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Mfg. Lic. No.: MFG/MD/2021/000435
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