Gima STERILE SURGICAL SCISSORS sharp/sharp, STERILE METZENBAUM SCISSORS User guide

PROFESSIONAL MEDICAL PRODUCTS

STRUMENTARIO CHIRURGICO STERILE
STERILE SURGICAL INSTRUMENTS
INSTRUMENTS DE CHIRURGIE STÉRILE
INSTRUMENTOS QUIRÚRGICOS ESTÉRIL
STERILE CHIRURGISCHE INSTRUMENTE
INSTRUMENTAL CIRÚRGICO ESTERILIZADO

STERYLNE NARZĘDZIA CHIRURGICZNE

STERIL SEBÉSZETI ESZKÖZÖK
STERIELE CHIRURGISCHE INSTRUMENTEN
STERILA KIRURGISKA INSTRUMENT

ΑΠΟΣΤΕΙΡΩΜΕΝΑ ΧΕΙΡΟΥΡΓΙΚΑ ΕΡΓΑΛΕΙΑ

Manuale d’uso - User manual - Manuel de l’utilisateur
Guía de uso - Gebrauchs- und instandhaltungsanleitung
Guia para utilização - Instrukcja obsługi - Használati
utasítás - Gebruikershandleiding - Användarhandbok
Οδηγίες χρήσης -

Gima S.p.A.

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

www.gimaitaly.com

ENGLISH

Products
Sterile surgical instruments:

• Straight scissors, Lister Bandage Scissors, Magill Catheter
Introducing Forceps, Hartmann Alligator Forceps: Medical de­vice Directive 93/42 EEC and subsequent amendments to, or
revisions of (2007/47 EEC), class I sterile devices, Annex IX.

• Mayo Dissecting Scissors, Metzenbaum Dissecting Scissors,
Iris Scissors, Umbilical Scissors, Dressing Forceps, Hunt­er Splinter Dressing Forceps, Adson Haemostatic
McIndoe Dissecting Forceps, Pean Forceps, Spencer Wells
Forceps, Halstead-Mosquito Haemostatic Forceps, Foerster
Sponge Holding Forceps, Hegar-Mayo Needle Holder, Crile­Wood Needle Holder, Bellucci Otology Surgery Scissors, Su­ture kit: Medical device Directive 93/42 EEC and subsequent
amendments to, or revisions thereof (2007/47 EEC), class IIa,
Annex IX.

Instructions

Sterile surgical instrumentation includes various types of devic­es which have different uses according to their shape and size.
They can be summarised as follows:

1. To cut threads, dressing, hair, etc.

2. To cut tight bandages

3. To grasp and position tracheal cannulas in the patient’s tra-

chea

4. To remove foreign objects from the ear

5. To cut hard tissue

6. To separate the anterior and posterior chambers of the eye

7. To cut the umbilical cord

8. To retract, grasp or dissect tissues during surgical proce-

dures. To maintain and position dressings, pads, to remove
dressings, pads and tissues; to insert/ablate foreign bodies

9. To maintain and position dressings, pads, to remove dress-

ings, pads and tissues; to insert/ablate foreign bodies

10. To hold tissues/arteries/blood vessels in place during surgi-

cal procedures

11. To hold sponges and pads in place

12. To hold and move the needle through the tissue during sutu-

ring

Storage

Store the surgical instruments in a cool, dry place.
Avoid impact which may damage the cutting edges.

Warnings

The disposable components supplied sterile, do not require
further washing and sterilisation operations before use. Should
the packaging be damaged, thereby compromising the sterility
of the devices, or should the sterility expiry date be exceeded,
the packaging including the enclosed components must be dis­posed of according to normal hospital procedures in a dispos­able container for hazardous infectious health waste intended
for the incinerator by order of Presidential Decree 254/03 and
subsequent amendments.
Reuse of the disposable device is prohibited. Reuse of the de­vices may compromise the characteristics of the material, result
in the failure of the device and on different patients may cause
serious infection.

Materials

All components have been manufactured using materials which
comply with the current national or international regulations ap­plicable to such devices.
In particular, the materials which come into contact with the pa­tient are made of AISI 420 steel compliant with ASTM F899-09.
Sterilisation
The surgical instruments are supplied sterile (gamma ray sterili­sation) as indicated by the symbol on the label, which also indi­cates the expiry date and that it is disposable.
Disclaimer: GIMA S.P.A. is not responsible for any direct, indirect
and/or incidental damage resulting from the use of the device,
whether this derives from the lack of control of its functionality,
sterilisation or validity, from the surgery or from the non-compli-

ance with the above-mentioned Instructions for Use.

Forceps,

IT - Codice prodotto
GB - Product code
FR - Code produit
ES - Código producto
DE - Erzeugniscode
PT - Código produto
PL - Numer katalogowy
HU - Termékszám / cikkszám
NL - Productcode/Art. nr.
SE - Produktreferens/Art. Nr.
GR - Κωδικός προϊόντος

IT - Numero di lotto
GB - Lot Number
FR - Numéro de lot
ES - Número de lote
DE - Chargennummer
PT - Número de lote
PL - Kod partii
HU - Tételszám / gyártási szám
NL - Partijnummer/Batchnummer
SE - Partinummer/batchnummer
GR - Αριθμός παρτίδας

IT - Data di scadenza
GB - Expiration date
FR - Date d’échéance
ES - Fecha de caducidad
DE - Ablaufdatum
PT - Data de validade
PL - Użyć przed / data ważności
HU - Felhasználhatósági / lejárati idő
NL - Te gebruiken voor / Vervaldatum
SE - Sista förbrukningsdag/utgångsdatum
GR - Ημερομηνία λήξεως (βλέπε συσκευασία/

σακουλάκι) Ημερομηνία λήξεως

IT - Fabbricante
GB - Manufacturer
FR - Fabricant
ES - Fabricante
DE - Hersteller
PT - Fabricante
PL - Producent
HU - Gyártó
NL - Geproduceerd door
SE - Tillverkad av
GR - Παραγωγός

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)
ES - Precaución: lea las instrucciones (advertencias)
cuidadosamente

DE - Achtung: Anweisungen (Warings) sorgfältig lesen
PT - Cuidado: leia as instruções (avisos) cuidadosa-

mente

PL - Ostrzeżenie ─ Zobacz instrukcję obsługi
HU - Figyelem / gyelmeztetés (Használat előtt olvassa

el az útmutatót!)

NL - Opgelet / Waarschuwing (Lees IFU voorafgaand

aan gebruik)
înainte de utilizare)
SE - Viktigt/Varning (läs bruksanvisningen före
användning)

GR - Προσοχή: διαβάστε προσεκτικά τις οδηγίες
(ενστάσεις)

- SA

- SA

- SA

- SA

- SA

IT - Leggere le istruzioni per lʼuso
GB - Please read instructions carefully
FR - Consulter les instructions d’utilisation
ES - Consultar las instrucciones de uso
DE - Gebrauchsanweisung beachten
PT - Consulte as instruções de uso
PL - Przeczytaj instrukcje użytkowania
HU - Nézzen utána az útmutatóban
NL - Raadpleeg de IFU
SE - Konsultera bruksanvisningen
GR - Διαβάστε προσεχτικά τις οδηγίες χρήσης

IT - Non utilizzare se l’imballaggio è danneggiato
GB - Don’t use if package is damaged
FR - Ne pas utiliser si le colis est endommagé
ES - No usar si el paquete está dañado
DE - Nicht verwenden, wenn das Paket beschädigt ist
PT - Não use se o pacote estiver danicado
PL - Nie używać, jeśli opakowanie jest uszkodzone
HU - Ne használja, ha a csomagolás sérült.
NL - Gebruik het product niet als de verpakking

beschadigd is

SE - Använd inte om förpackningen är skadad
GR - Μην το χρησιμοποιείτε αν η συσκευασία είναι

κατεστραμμένη

IT - Conservare in luogo fresco ed asciutto
GB - Keep in a cool, dry place
FR - Á conserver dans un endroit frais et sec
ES - Conservar en un lugar fresco y seco
DE - An einem kühlen und trockenen Ort lagern
PT - Armazenar em local fresco e seco
PL - Przechowywać w suchym miejscu
HU - Tartsa szárazon!
NL - Droog bewaren
SE - Förvaras torrt
GR - Διατηρείται σε δροσερό και στεγνό

περιβάλλον

IT - Conservare al riparo dalla luce solare
GB - Keep away from sunlight
FR - Á conserver à l’abri de la lumière du soleil
ES - Conservar al amparo de la luz solar
DE - Vor Sonneneinstrahlung geschützt lagern
PT - Guardar ao abrigo da luz solar
PL - Przechowywać z dala od światła słonecznego
HU - Napfénytől tartsa távol.
NL - Bescherm tegen zonlicht
SE - Skyddas från solljus
GR - Κρατήστε το μακριά από ηλιακή ακτινοβολία

IT - Non ri-sterilizzare GB - Do not resterilize
FR - Ne pas restériliser ES - No reesterilizar

z

DE - Nicht resterilisieren PT - Não reesterilize
PL - Nie sterylizuj ponownie HU - Újra sterilizálni tilos!
NL - Niet hersteriliseren SE - Återsterilisera inte
GR - Μην αποστειρώνετε

IT - Dispositivo monouso, non riutilizzare
GB - Dispositif pour usage unique, ne pas réutiliser
FR - Ne pas réutiliser ES - Dispositivo monouso,

no reutilizable DE - Für einmaligen Gebrauch, nicht
wiederverwenden PT - Dispositivo descartável, não
reutilizar PL - Jedno urządzenie, nie używaj ponownie

HU - Újrahasználni tilos! NL - Niet hergebruiken
SE - Återanvänd ej GR - Προϊόν μιας χρήσεως. Μην

το χρησιμοποιείται εκ νέου

IT - Dispositivo medico conforme alla
Direttiva 93/42/CEE

GB - Medical Device complies with Directive 93/42/EEC
FR - Dispositif médical conforme à la directive

93/42 / CEE

ES - Dispositivo médico segun a la Directiva

93/42 / CEE

DE - Medizinprodukt gemäß Richtlinie 93/42/CEE
PT - Dispositivo médico em conformidade

com a Diretiva 93/42/CEE

PL - Wyrób medyczny zgodny z dyrektywą 93/42 / CEE
HU - Orvosi eszköz a 93/42 / EGK irányelvnek

megfelelően

NL - Medisch hulpmiddel in overeenstemming
met Richtlijn 93/42 / EEG
RO - Dispozitiv medical în conformitate
cu Directiva 93/42 / CEE

SE - Medicinsk utrustning enligt direktiv 93/42 / EEG
GR - Ιατρική συσκευή σύμφωνα με την οδηγία

93/42 / CEE

IT - Sterilizzato per irradiazione
GB - Sterilized using irradiation
FR - Stérilisé par irradiation
ES - Esterilizado por irradiación
DE - Durch Bestrahlung steril gemacht
PT - Esterilizado por irradiação
PL - Sterylizowane przez napromieniowanie
HU - Gamma-sugárzással sterilizált
NL - Gesteriliseerd met gammastraling
SE - Steriliserad med gammastrålning
GR - Αποστειρωμένο μέσω ακτινοβολίας

- SA

- SA

- SA

- SA

- SA

- SA

- SA

- SA

Gima S.p.A.

Via Marconi, 1
20060 Gessate (MI) Italy
Made in Pakistan

0476

z

M38800-M-Rev.0-04.19