Gima BSN0316U, 22890, BSN0326U, 22891, BSN0315U User guide

Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]

PROFESSIONAL MEDICAL PRODUCTS

TRUBARB

TM

www.gimaitaly.com

SUTURA CHIRURGICA RIASSORBIBILE CON AGO.
DISPOSITIVO DI CHIUSURA DEI TESSUTI SENZA NODI
(SINTETICO).
MONOFILAMENTO IN POLIDIOSSANONE.

ABSORBABLE SURGICAL NEEDLED-SUTURE (SYNTHETIC).
KNOTLESS TISSUE-CLOSURE DEVICE
MONOFILAMENT POLYDIAXANONE.

SUTURE CHIRURGICALE NON RÉSORBABLE MONTÉE SUR
AIGUILLE (SYNTHÉTIQUE)
DISPOSITIF DE FERMETURE TISSULAIRE SANS NŒUDS.
POLYDIOXANONE MONOFILAMENT.

RESORBIERBARE CHIRURGISCHE NADEL-NAHT
(SYNTHETISCHES).
KNOTENLOSES GEWEBEVERSCHLUSSINSTRUMENT
MONOFILAMENT POLYDIAXANON.

SUTURA QUIRÚRGICA ABSORBIBLE CON AGUJA.
DISPOSITIVO DE CIERRE DE TEJIDO SIN NUDOS
(SINTÉTICO).
POLIDIAXANONA MONOFILAMENTO.

DISPOSITIVO DE FECHO DE TECIDO SEM NÓS (SINTÉTICO).
SUTURA DE AGULHA CIRÚRGICA, ABSORVÍVEL.
MONOFILAMENTO POLIDIOXANONA.

ΑΠΟΡΡΟΦΉΣΙΜΟ ΧΕΙΡΟΥΡΓΙΚΟ ΡΑΜΜΑ ΜΕ ΒΕΛΟΝΑ
(ΣΥΝΘΕΤΙΚΟ).
ΣΥΣΤΉΜΑ ΣΥΓΚΛΙΣΉΣ ΙΣΤΏΝ ΧΏΡΙΣ ΚΟΜΠΟ.
ΜΟΝΟΚΛΏΝΟ ΑΠΟ ΠΟΛΥΔΙΟΞΑΝΟΝΉ.

Manuale d’uso - User manual - Manuel de l’utilisateur
Guía de uso - Gebrauchs- und instandhaltungsanleitung
Guia para utilização - Οδηγίες χρήσης

ENGLISH

DESCRIPTION

The Polydiaxanone Knotless Tissue-Closure Device is comprised
of barbed dyed Polydiaxanone (PDO) suture material, armed with
a surgical needle on one end and end stopper at the other end.
The Polydiaxanone Knotless Tissue-Closure Device barbs are
oriented in one direction to allow for tissue approximation without
the need to tie surgical knots. Polydiaxanone Knotless Tissue-Clo­sure Device is consisting of dyed (violet) polyester, poly(p-dioxa­none). The empirical molecular formula of which is (C4H6O3)X.
The pigment for the violet dye is D&C Violet No. 2. Polydiaxanone
has been found to be nonantigenic, nonpyrogenic and to elicit only
a slight tissue reaction during absorption. While the formation of
barbs in the Polydioxanone Knotless Tissue- Closure Device redu­ces the tensile strength relative to non- barbed suture material of
the same size, tying of knots in non- barbed suture materials also
reduce their effective strength. For this reason, the strength of the
Polydiaxanone Knotless Tissue- Closure Device can be compared
to USP knot strength of non- barbed sutures. Additionally, USP
designations for diameter are used to describe the Polydioxanone
Knotless Tissue-Closure Device prior to barbing, except for minor
variation in suture diameter with a maximum overage of 0.14mm.

Tensile Strength/Size Equivalency

Polydiaxanone
Knotless Tissue­Closure Device size

1 2 1/5.08

0 1 0/3.90

2-0 0 2-0/2.68

3-0 2-0 3-0/1.77

4-0 3-0 4-0/0.95

5-0 4-0 5-0/0.68

ACTIONS

Two important characteristics describe the in vivo performance of
absorbable sutures: rst, tensile strength retention and second,
the absorption rate (loss of mass). Polydiaxanone Knotless Tis­sue-Closure Device has been formulated to minimize the variabi­lity of these characteristics and to provide wound support through
the critical wound healing period and an extended healing period.

Pre-Barbing
Suture Size

Equivalent Non­Barbed Size(USP)/
Tensile Strength(Kgf)

The results of implantation studies in animals using
Polydiaxanone Knotless Tissue-Closure Device
indicate that

Days Implantation Approximate % Original Strength

14 days 75%

28 days 65%

42 days 55%

Absorption of Polydiaxanone Knotless Tissue-Closure Device is
essentially complete between 180 to 220 days.

INTENDED PURPOSE

Polydiaxanone Knotless Tissue-Closure Device is indicated for
use in soft tissue approximation where use of Polydiaxanone
absorbable suture is appropriate.

CONTRAINDICATIONS

Polydioxanone Knotless Tissue-Closure Device is not to be used
where prolonged (beyond six weeks) approximation of tissues un­der stress is required and is not to be used in conjunction with
or for xation of prosthetic devices (e.g. heart valves or synthetic
grafts) that are non-absorbable in nature.

WARNINGS

Do not resterilize. Discard opened, unused Polydioxanone Knot­less Tissue-Closure Device and associated surgical needles.
Users should be familiar with surgical procedure and techniques
involving absorbable sutures before employing Polydioxanone
Knotless Tissue-Closure Device for wound Closure, as risk of
wound dehiscence may vary with the site of application and the
suture material used. Physicians should consider the in vivo per­formance (under ACTIONS section) when selecting a suture for
use in patients. The use of this suture may be inappropriate in el­derly, malnourished or debilitated patients, or in patients suffering
from conditions which may delaywound healing.
The safety and effectiveness of Polydioxanone Knotless Tissue­Closure Device has not been established for use in fascial closu­res (including abdominal wall, thoracic and extremity fascial closu­res), gastrointestinal anastomoses, cardiovascular tissue, neural
tissue, osseous tissue, tendinous tissue, ophthalmic surgery, or
for use in microsurgery, therefore this product should not be used
for these purposes.
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, Poly­dioxanone Knotless Tissue-Closure Device may act transiently as
a foreign body. Acceptable surgical practice should be followed for
the management of contaminated or infected wounds.
As this is an absorbable suture material, the use of supplemental

Remaining

nonabsorbable sutures should be considered by the surgeon in
the Closure of the sites which may undergo expansion, stretching
or distention or which may require additional support.

PRECAUTIONS

Polydioxanone Knotless Tissue-Closure Device contains unidi­rectionally oriented barbs to anchor tissues and does not require
knots to approximate opposing edges of a wound. Tying knots on
the barbed section of the material will damage the barbs and po­tentially reduce the suture tensile strength and barb effectiveness.
Additionally, when completing placement, an additional backstitch
or bite of tissue lateral to the end of the incision is required to lock
the device in place. Avoid contacting the Polydioxanone Knotless
Tissue-Closure Device and associated needles with other ma­terials (e.g. surgical gauze, drapes, etc.) in the surgical eld to
prevent ensnaring on the barbs. If the barbs catch, carefully pull
the material in the opposite direction of the needle to disengage
it from the barbs.
Care should be taken to avoid damage when handling. Avoid
crushing or crimping the suture material with surgical instruments,
such as needle holders and forceps. Do not pull the Polydioxa­none Knotless Tissue-Closure Device out of the package by the
needles as this can cause the barbs to catch on one another. Do
not attempt to remove memory in the polymer.
by running ngers down the suture material as this can damage
the barbs.
Infections, erythema, foreign body reactions, transient inam­matory reactions and in rare instances wound dehiscence are
typical or foreseeable risks associated with any suture and hence
are also potential complications associated with Polydiaxanone
Knotless Tissue-Closure Device.
When using Polydiaxanone Knotless Tissue-Closure Device sub­cutaneously, the device should be placed as deeply as possible
in order to minimize erythema and induration normally associated
with absorption. Acceptable surgical practice should be followed
with respect to drainage and Closure of infected wounds.
To avoid damaging needle points and swage areas, grasp the
needle in an area one-third (1/3) to one-half (1/2) of the distance
from the swaged end to the point. 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 sticks. Discard used needles
in “sharps” containers.

ADVERSE REACTIONS

Adverse effects associated with the use of this device may inclu­de, wound dehiscence, failure to provide adequate wound support
in closure of the site where expansion, stretching or distension
occur, failure to provide adequate wound support in elderly, mal­nourished or debilitated patients or in patients suffering from con­ditions which may delay wound healing, infection, minimal acute
inammatory tissue reaction, localized irritation when skin sutures
are left in place for greater than 7 days, suture extrusion and dela­yed absorption in tissue with poor blood supply, calculi formation
in urinary and biliary tracts when prolonged contact with salt solu­tions such as urine and bile occurs and transitory local infection at
the wound site. Broken needles may result in extended or additio­nal surgeries or residual foreign bodies. Inadvertent needle sticks
with contaminated surgical needles may result in the transmission
of bloodborne pathogens. Due to prolonged suture absorption,
some irritation and bleeding may occur.

APPLICATION

Polydiaxanone Knotless Tissue-Closure Device is designed to be
used in continuous suture patterns and intended to be used wi­thout anchoring knots to begin or terminate the device line

Use as required per surgical procedure.

Secure the xation end stopper portion to robust tissue by taking
a bite in the designated tissue, passing the needle and pulling
tautly around the anchoring tissue.
After Polydiaxanone Knotless Tissue-Closure Device is anchored
into the tissue, grasp the strand and approximate tissue to the
desired tension. Bites, or passes through the tissue, can be taken
in a continuous suturing technique to approximate the wound.
Care should be taken to utilize the Polydioxanone Knotless Tis­sue-Closure Device on the barbed segments only. Do not attempt
to approximate wounds using the non-barbed segment near the

needle, as the barbs are required for successful wound approxi­mation with the Polydioxanone Knotless Tissue-Closure Device.
To complete the closure in subcuticular closure, take at least one
pass in the reverse direction. Then pass the needle across the in­cision and take a split thickness bite perpendicular to the incision
and exit the skin.
To complete the closure in all other tissue layers, take at least
two passes in the reverse direction to complete the closure. Then
gently pull on the free end of the device and cut ush with the
surface of the tissue.

STERILITY

Polydiaxanone Knotless Tissue-Closure Device is sterilized by
ethylene oxide gas. Do not resterilize. Do not use if package is
opened or damaged. Discard opened unused sutures. Do not use
after expiration date.

HOW SUPPLIED

Polydiaxanone Knotless Tissue-Closure Device is available steri­le, in various sizes in unidirectional barb congurations attached
with various needle type, shape and length which are packed in a
printed box, quantity as indicated on the label.

STORAGE

Recommended storage conditions: Below 30° C away from mois­ture and direct sunlight. Do not use after expiry.

DISPOSAL

Discard used sutures and needles contaminated with blood in
the container meant for infection waste. Unused expired pouches
should be Incinerated or Disposal should be done as per local
regulation.

IT -

Identicatore univoco del dispositivo

FR -

Identiant unique de l’appareil

tier
spositivo único
exclusivo do dispositivo

IT - Attenzione: Leggere e seguire attentamente le istruzioni (avver­tenze) per l’uso GB - Caution: read instructions (warnings) careful­ly FR - Attention: lisez attentivement les instructions (avertissements)
DE - Achtung: Anweisungen (Warings) sorgfältig lesen ES - Precau­ción: lea las instrucciones (advertencias) cuidadosamente PT - Cu­idado: leia as instruções (avisos) cuidadosamente GR - Προσοχή:
διαβάστε προσεκτικά τις οδηγίες (ενστάσεις)

BSN0316U (GIMA 22890)
BSN0326U (GIMA 22891)
BSN0315U (GIMA 22892)
BSN0325U (GIMA 22893)
BSN0615U (GIMA 22894)
BSN0624U (GIMA 22895)
BSN110 0U (GIMA 22896)

MED DEVICES LIFESCIENCES B.V.

Kraijenhoffstraat 137 A, 1018RG Amsterdam, Netherlands
Email: [e-mail] Phone: [phone]

Gima S.p.A.

Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]

www.gimaitaly.com

DE -

Eindeutige Gerätekennung

GR -

GB

- Unique device iden-

ES -

Identicador de di-

Μοναδικό αναγνωριστικό συσκευής

PT -

Identicador

IT -

Codice prodotto
Erzeugniscode
Κωδικός προϊόντος

IT -

Dispositivo monouso, non riutilizzare
do not re-use
nicht wiederverwenden

Dispositivo descartável, não reutilizar

-

Μην το χρησιμοποιείται εκ νέου

IT -

Numero di lotto
Chargennummer
Αριθμός παρτίδας

IT -

Data di fabbricazione
fabrication
Data de fabrico

IT -

Data di scadenza

DE -

Ablaufdatum

GR -

Ημερομηνία λήξεως

IT -

Sterilizzato con ossido di etilene

FR -

oxide

ES -

noxid
óxido de etileno

IT - Rappresentante autorizzato nella Comunità europea GB - Authori­zed representative in the European community FR - Représentant au­torisé dans la Communauté européenne DE - Autorisierter Vertreter in
der EG ES - Representante autorizado en la Comunidad Europea PT -
Representante autorizado na União Europeia GR - Εξουσιοδοτημένος
αντιπρόσωπος στην Ευρωπαϊκή Ένωση

IT -

Fabbricante

ES -

Fabricante

IT -

Non ri-sterilizzare

DE -

Nicht erneut sterilisieren

er

z

esterilize GR -

IT -

Conservare in luogo fresco ed asciutto

FR -

place
en un lugar fresco y seco

PT -

lagern
δροσερό και στεγνό περιβάλλον

IT -

Conservare al riparo dalla luce solare

FR -

sunlight
Sonneneinstrahlung geschützt lagern
la luz solar
μακριά από ηλιακή ακτινοβολία

IT - Limite superiore di temperatura GB - Upper limit of temperature

30°C

FR - Limites supérieure de température DE - Obergrenze der Tem­peratur ES - Limitaciones superiorde temperatura PT - Limitação su­perior de temperatura

IT -

Non utilizzare se l’imballaggio è danneggiato

if package is damaged

DE -

magé
No usar si el paquete está dañado
ver danicado
κατεστραμμένη

IT -

Leggere le istruzioni per lʼuso

FR -

Consulter les instructions d’utilisation
sung beachten
sulte as instruções de uso
χρήσης

IT -

Dispositivo medico conforme alla Direttiva 93/42/CEE
dical Device complies with Directive 93/42/EEC
ical conforme à la directive 93/42 / CEE
Richtlinie 93/42/CEE
93/42 / CEE
retiva 93/42/CEE
93/42 / CEE

Healthium Medtech Private Limited

Plot No.1600, R-6 West, Sri City (SEZ),
Chervi Village, Irrugulam Post, Satyavedu Mandal, Chittoor District,
Andhra Pradesh- 517588, India
Email : [e-mail]
Mfg. Lic. No.: 42/CT/AP/2012/S/R

z

GB

- Product code

ES -

Código producto

FR -

Ne pas réutiliser

ES -

Dispositivo monouso, no reutilizable

GB

- Lot Number

ES -

Número de lote

DE -

Stérilisé à l’oxyde d’éthylène
Esterilizado con óxido de etileno

Á conserver dans un endroit frais et sec

Armazenar em local fresco e seco

PT -

Nicht verwenden, wenn das Paket beschädigt ist

GB

Herstellungsdatum

GR -

Ημερομηνία παραγωγής

GB

- Expiration date

ES -

Fecha de Caducidad

GR -

Αποστειρωμένο με αιθυλενοξείδιο

GB

- Manufacturer

PT -

Fabricante

GB

- Do not resterilize

Μην αποστειρώνετε

DE -

Á conserver à l’abri de la lumière du soleil

Guardar ao abrigo da luz solar

GR - Ανώτερο

FR -

Ne pas utiliser si le colis est endom-

GR -

Μην το χρησιμοποιείτε αν η συσκευασία είναι

ES -

Consultar las instrucciones de uso

GR -

ES -

Dispositivo médico segun a la Directiva

PT -

Dispositivo médico em conformidade com a Di-

GR -

Ιατρική συσκευή σύμφωνα με την οδηγία

FR -

Code produit

PT -

Código produto

GB

- Disposable device,

DE -

Für einmaligen Gebrauch,

GR -

Προϊόν μιας χρήσεως.

FR -

Numéro de lot

PT -

Número de lote

- Date of Manufacturing

ES -

Fecha de fabricación

GB

DE -

FR -

GR -

Παραγωγός

ES -

No reesterilizar -

An einem kühlen und trockenen Ort

ES -

όριο θερμοκρασίας

PT -

Não use se o pacote esti-

GB

- Consult instructions for use

Διαβάστε προσεχτικά τις οδηγίες

DE -

FR -

FR -

Date d’échéance

PT -

Data de validade

- Sterilized using ethylene
Sterilisiert mit Ethyle-

PT -

Esterilizado com

Fabricant

DE -

Hersteller

FR -

Ne pas restérilis-

PT - Não re-

GB

- Keep in a cool, dry

ES -

Conservar

GR -

Διατηρείται σε

GB

- Keep away from

Conservar al amparo de

GR -

Κρατήστε το

GB

- Don’t use

DE -

Gebrauchsanwei-

PT -

GB

FR -

Dispositif méd-

Medizinprodukt gemäß

2265

30°C

DE -

GR -

DE -

GR -

Date de

DE -

ES -

Con-

- Me-

PT

PT -

Vor

M22890-Rev.0-11.22