Gima TRUBOND NON ABSORB. SUTURE gauge 4/0 circle 3/8 needle 16 mm User guide

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

PROFESSIONAL MEDICAL PRODUCTS

TRUBOND

FILO DA SUTURA CHIRURGICA NON RIASSORBIBILE USP
(POLIESTERE RIVESTITO)

NONABSORBABLE SURGICAL SUTURE U.S.P
(COATED POLYESTER)

SUTURE CHIRURGICALE NON RÉSORBABLE USP
(POLYESTER ENDUIT)

NICHT-RESORBIERBARES CHIRURGISCHES NAHTMATERIAL U.S.P
(BESCHICHTETES POLYESTER)

SUTURA QUIRÚRGICA NO ABSORBIBLE U.S.P
(POLIÉSTER RECUBIERTO)

SUTURA CIRÚRGICA NÃO ABSORVÍVEL U.S.P
(POLIÉSTER REVESTIDO)

ΜΗ ΑΠΟΡΡΟΦΗΣΙΜΟ ΧΕΙΡΟΥΡΓΙΚΟ ΡΑΜΜΑ U.S.P
(ΕΠΙΚΑΛΥΜΜΕΝΟΣ ΠΟΛΥΕΣΤΕΡΑΣ)

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

TM

www.gimaitaly.com

ENGLISH

DESCRIPTION

Trubond is a nonabsorbable, sterile, surgical suture, composed affine la­ments of Polyester, Poly Ethylene Tere Phthalate. The ne polyesterbres
are braided to produce rm suture that remains soft and pliable. Trubond is
colored green with D&C Green No.5, USFDA.
Approved dye. Trubond is available undyed also. For added lubrication and
smoothness, Trubond is coated with Silicon. Trubond meets ali the require­ments, established by the Uniteci States Pharmacopeia far Nonabsorbable
Surgical suture.

INTENDED PURPOSE

Trubond is indicateci far use in soft tissue approximation and or ligation, inclu­ding use in cardiovascular, ophthalmic and neurological tissues.

ACTION

Trubond being a braided suture, enables far secured knots. Trubond is soft
and pliable. lt is very easy to handle. lt elicits an initial intlammatory reaction
in tissues which is fallowed by graduai encapsulation of the suture by brous
connective tissue. Trubond is not absorbed, nor is it subjected to degradation
or weakening bythe action of tissue enzymes. Due to its total biologica! inert­ness, it is recommended far use where the least possible suture reaction is
desired. Because of its lack of adherence to tissue, Trubond is effective as
a pull out suture.

CONTRA INDICATIONS

NoneKnown.

WARNINGS

Do not reuse. Discard open, unused sutures. Prolonged contact of this sutu­re or anyothersuture with salt solutions such as those found in urinary and
biliary tracts, may result in calculus formation. Users should be familiarwith
surgical procedures and techniques involving no absorbable sutures before
employing Trubond for wound closures, as risk of wound dehiscence may
vary with the site of application and the suture materiai used. As any foreign
materiai in the presence of bacterial contamination may enhance bacterial
infectivity acceptable surgical practice must be followed with respect to drai­nage and closure of infected orcontaminated wounds.

PRECAUTIONS

In handling Trubond suture or any other suture materiai care should be taken
to avoid damage from handling. Avo id crushing or crimping damage due to
application of surgical instruments such as forceps or needle holders. As
with any suture materiai, adequate knot security requires the accepted sur­gical techniques of at 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 effects associateci with the use of Trubond include minimal initial
inammatory tissue reaction and transient locai irritation at the wound site,
calculi formation in urinary and biliary tracts when prolonged contact with salt
solutions such as urine and bile juice etc.
Trubond may patentiate an existing infection.

SUPPLY

Trubond is available in various U.S.P. sizes, The suture is supplied sterile
in pre-cut lengths, both non- needled and attached tovarious needle type,
shape and length. which are packed in a printed box quantity as indicateci
on the box la bel.

STORAGE

Recommended storage conditions: Below 30° C awayfrom moisture and di­rectsunlight. Do not use afterexpiry.

DIPOSAL

Discard used sutures and needles contaminateci with blood in the container
meant infection waste. Unused expired pouches should be incinerateci or
Disposal should be done as per loca I 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:
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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 - Authori-
zed 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

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 -

PT -

Dispositivo médico segun a la Directiva

Dispositivo médico em conformidade com a Di-

GR -

Ιατρική συσκευή σύμφωνα με την οδηγία

z

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

PT -

DE -

Vor

ES -

Con-

- Me-

PT

M22770-Rev.0-11.22