Gima TRULENE NON ABSORBABLE MESH 6x11cm User guide

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

PROFESSIONAL MEDICAL PRODUCTS

TRULENE MESH

RETE CHIRURGICA SINTETICA NON RIASSORBIBILE,
IN POLIPROPILENE, STERILE

POLYPROPYLENE NON ABSORBABLE SYNTHETIC
SURGICAL MESH, STERILE

POLYPROPYLÈNE SYNTHÉTIQUE NON RÉSORBABLE
FILET CHIRURGICAL, STÉRILE

POLYPROPYLEN NICHT-RESORBIERBARER
KUNSTSTOFF CHIRURGISCHES NETZ, STERIL

POLIPROPILENO SINTÉTICO NO ABSORBIBLE
MALLA QUIRÚRGICA ESTERILIZADA

POLIPROPILENO NÃO ABSORVÍVEL SINTÉTICO
MALHA CIRÚRGICA, ESTERILIZADA

ΜΗ ΑΠΟΡΡΟΦΗΣΙΜΟ ΣΥΝΘΕΤΙΚΟ ΠΟΛΥΠΡΟΠΥΛΕΝΙΟ
ΧΕΙΡΟΥΡΓΙΚΟ ΠΛΕΓΜΑ, ΑΠΟΣΤΕΙΡΩΜΕΝΟ

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

www.gimaitaly.com

TM

ENGLISH

DESCRIPTION

Trulene mesh is constructed of knitted laments of ex­truded Polypropylene, identical in composition with that
used in Trulene polypropylene suture, Non absorbable
surgical suture U.S.P. Trulene Mesh is available undyed
in a variety of square and rectangular sizes for surgi­cal procedures. This material, when used as sutures
has been reported to be nonreactive and to retain its
strength for an indenite period in clinical use.

Trulene mesh is knitted by a process which interlinks
each ber junction and which provides for elasticity in
both directions. This construction permits the mesh to
be cut into any desired shape or size without unravel­ling. The ber junctions are not subject to the same work
– fatigue exhibited by more rigid metallic meshes. This
bi-directional elastic properly allows adaptation to vari­ous stresses encountered in the body.

ACTIONS

Trulene mesh is a non absorbable mesh used to span
and reinforce traumatic or surgical wounds to provide
extended support during and following wound healing.
This mesh elicits minimum inammatory reaction, which
is transient and is followed by the deposition of a thin
brous layer of tissue which can grow through the inter­stices of the mesh, thus incorporating the mesh into the
adjacent tissue. The mesh remains soft, pliable and the
wound healing is not noticeably impaired. The mesh is
not absorbed nor is subject to degradation or weakening
by the action of tissue enzymes.

INTENDED PURPOSE

Trulene Mesh used for the repair of hernia. Types of
Hernia: Inguinal Hernia and Ventral Hernia.

CONTRAINDICATIONS

When this mesh is used in infants or children with fu­ture growth potential and pregnant women, the surgeon
should be aware that this product will not stretch signif­icantly as the patient grows. Trulene Mesh in contam­inated wounds should be used with the understanding
that subsequent infection may require removal of the
material.

WARNING

Trulene mesh is supplied as a sterile product. Re sterili­zation is not recommended.

RISK OF REUSE

Reprocessing or sterilization of this device may create
the risk of contamination and patient infection. Do not
reuse, reprocess or resterilize the Trulene mesh.

PRECAUTIONS

Users should be familiar with surgical procedures and
techniques involving the use of non-absorbable meshes
before employing Trulene mesh in wound repair or rein­forcement and brief the patients about contraindications
and precautions. A minimum of 6.5 mm inside the edge
mesh extend beyond the suture line.

ADVERSE REACTIONS

Potential adverse reactions with Trulene mesh implanta­tion are those typically associated with surgical implant­able materials which including seroma formation, inam­mation, adhesion formation, stula formation, extrusion
and potentiation of infection.

INSTRUCTIONS FOR USE

Mesh is implanted according to currently accepted sur­gical mesh procedures.
Some surgeons prefer to suture an uncut section of
mesh that is considerably larger than the defect into
position over the wound. The opposite sides are then
sutured to assure proper closure under correct tension.
When the margin sutures have all been placed, the extra
mesh is trimmed away.
Adequate mesh xation is required to minimize post-op­erative complications and recurrence. The xation tech­nique method and products used should follow the cur­rent standard of care. Careful attention to xation and
spacing will help prevent excessive tension or disruption
between the mesh materials and connective tissue.
When xating with non-absorbable sutures or other me­chanical xation devices, a safe from the edge of the
mesh of not less than 6.5mm (¼’’) must be maintained.

6.5 mm to 12.5mm (¼’’ to ½’’) should be left between
xation points.

SUPPLY

Trulene mesh is available in various sizes which are
packed in a printed box quantity as indicated on the box
label.

STORAGE

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

Healthium Medtech Private Limited

No. 472/D, 13th Cross, 4th Phase
Peenya Industrial Area,
Bangalore 560 058, India
Email : [e-mail]
Mfg. Lic. No.: MFG/MD/2019/000139

MED DEVICES LIFESCIENCES B.V.

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

IT - Attenzione: Leggere e seguire attentamente le istruzioni (avver­tenze) per l’uso GB - Caution: read instructions (warnings) careful-

ly FR - Attention: lisez attentivement les instructions (avertissements)
DE - Achtung: Anweisungen (Warings) sorgfältig lesen ES - Precau-

ción: lea las instrucciones (advertencias) cuidadosamente PT - Cu-
idado: leia as instruções (avisos) cuidadosamente GR - Προσοχή:
διαβάστε προσεκτικά τις οδηγίες (ενστάσεις)

IT -

Codice prodotto
Erzeugniscode
Κωδικός προϊόντος

IT -

Dispositivo monouso, non riutilizzare

do not re-use

nicht wiederverwenden

Dispositivo descartável, não reutilizar GR -

-

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

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 Tem-
peratur ES - Limitaciones superiorde temperatura PT - Limitação su-

perior de temperatura

IT -

Non utilizzare se l’imballaggio è danneggiato
package is damaged

DE- Nicht verwenden, wenn das Paket beschädigt ist

gé
usar si el paquete está dañado
danicado
κατεστραμμένη

IT -

Leggere le istruzioni per lʼuso

FR -

Consulter les instructions d’utilisation DE ­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
tiva 93/42/CEE
93/42 / CEE

GB

- Product code

ES -

Código producto

FR -

Ne pas réutiliser DE -

ES -

Dispositivo monouso, no reutilizable

GB

- Lot Number

ES -

Número de lote

DE- Herstellungsdatum

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

GR

Á conserver dans un endroit frais et sec

Armazenar em local fresco e seco GR -

PT -

GR -Μην το χρησιμοποιείτε αν η συσκευασία είναι

PT -

GB

GR - Ημερομηνία παραγωγής

GB

- Expiration date

ES -

Fecha de Caducidad

GR - Αποστειρωμένο με αιθυλενοξείδιο

GB

- Manufacturer

PT -

Fabricante GR -

GB

- Do not resterilize

-

Μην αποστειρώνετε

DE- An einem kühlen und trockenen Ort

Á conserver à l’abri de la lumière du soleil DE -

Guardar ao abrigo da luz solar GR -

GR

-

Ανώτερο

FR -

Ne pas utiliser si le colis est endomma-

ES -

Consultar las instrucciones de uso

GR - Διαβάστε προσεχτικά τις οδηγίες

ES -

Dispositivo médico segun a la Directiva

Dispositivo médico em conformidade com a Dire-

GR-Ιατρική συσκευή σύμφωνα με την οδηγία

z

FR -

Code produit DE -

PT -

Código produto GR -

GB

- Disposable device,

Für einmaligen Gebrauch,

Προϊόν μιας χρήσεως.

FR -

Numéro de lot DE -

PT -

Número de lote GR -

- Date of Manufacturing
ES -

Fecha de fabricación

FR -

PT -

GB

- Sterilized using ethylene

Sterilisiert mit Ethyle-

PT -

FR -

Fabricant

Παραγωγός

ES -

FR -

No reesterilizar -

GB

- Keep in a cool, dry

GB

ES -

Conservar al amparo de

όριο θερμοκρασίας

PT -

Não use se o pacote estiver

GB

- Consult instructions for use

FR -

DE -Medizinprodukt gemäß

PT

FR -

Date de

PT -

Date d’échéance
Data de validade

Esterilizado com

DE -

Hersteller

Ne pas restérilis-

PT - Não re-

ES -

Conservar

Διατηρείται σε

- Keep away from

GB

Gebrauchsanwei-

Vor

Κρατήστε το

- Don’t use if

ES -

No

PT -

Con-

GB

- Me-

Dispositif méd-

2265

30°C

M23012-Rev.0-09.19