Gima SUPER CUT, ENT KIT User guide

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PROFESSIONAL MEDICAL PRODUCTS
I GB - SURGICAL INSTRUMENTS
These instruments are intended to be used by medical practitioners who are spe-cially trained inappropri-ate maintenance can rapidly lead to deterioration of the instruments. The first time, and after every use it is recommended to clean, dry and sterilise the instruments. The instruments must always be cleaned prior to sterilisation. For automated clean-ing use only washing equipment with approved and certified detergents. For manu-al cleaning use approved and certified detergents, brush and running water. Always follow instructions on how to use the detergent; clean the instruments both when open and closed; rinse for 3 minutes and check that water also enters and exits the blind holes several times. Use completely demineralised water in the final rinse phase. Instruments that are not dried could suffer damage by corrosion. Always dry the instruments. After cleaning, and before sterilisation it is recommended that you treat the instruments with physiologically safe oil, especially the tips, connectors, terminals and all moving parts. Also make sure that the product does not come
into contact with instruments must be sterilized in autoclave by moist heat sterilization method at 132°C for 15 minutes prior to use in surgery. It is recommended that sterilization temperatures should not exceed 137°C. The process of steam sterilisation must take place in accordance with EN ISO 17664. In the context of validating the ster­ilisation process, check the suitability of the specic measures for drying. The hu­midity in the container can cause the instruments to rust. Often bad, and insufcient drying, is due to the incorrect positioning of the load and the use of unsuitable types of cloths for drying. There is no advice about maximum number of sterilisation cycles, this depends largely on the state of the product. Instruments that show signs of corrosion must be discarded immediately. Always perform a visual inspection for damage or signs of wear: sharp edges must be free of dents and with continuous edges; there should be no distortion of instruments with long parts; the instruments that are part of a larger assembly, must be checked together with other assembly components; always check the rotating movement of hinges, which must not have excessive play; always check that the locking systems are working. Whilst the instruments are under warranty, repairs and/or replacement of all defective parts, for reasons that are accepted by the manufacturer, are free, with the exception of costs for labour, travel, transport, packing, etc. Damage caused by improper use of the product is not covered by the warranty.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
WARNINGS All serious accidents concerning the medical device supplied by us must be re­ported to the manufacturer and competent authority of the member state where
your registered office is located.
on how to use and care of them. The incorrect use, poor or
acids or other aggressive disinfectants that could corrode it. The
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Simboli / Symbols / Symboles / Symbole / Simbolos / Simbolos / Σύμβολα /
IT Fabbricante GB Manufacturer FR Fabricant ES Fabricante PT Fabricante DE Hersteller GR Παραγωγός
IT Data di fabbricazione GB Date of manufacture FR Date de fabrication ES Fecha de fabricación PT Data de fabrico DE Herstellungsdatum GR Ημερομηνία παραγωγής
IT Non sterile GB Non-sterile FR Pas stérile ES No estéril PT Não estéril DE Nicht steril GR Οχι αποστειρωμένο
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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 PT Cuidado: leia as instruções (avisos) cuidadosamente DE Achtung: Anweisungen (Warnungen) sorgfältig lesen GR Προσοχή: διαβάστε προσεκτικά τις οδηγίες (ενστάσεις)
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IT Leggere le istruzioni per lʼuso GB Consult instructions for use FR Consulter les instructions d’utilisation ES Consultar las instrucciones de uso PT Consulte as instruções de uso DE Gebrauchsanweisung beachten GR Διαβάστε προσεχτικά τις οδηγίες χρήσης
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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 PT Guardar ao abrigo da luz solar DE Vor Sonneneinstrahlung geschützt lagern GR Κρατήστε το μακριά από ηλιακή ακτινοβολία
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 PT Armazenar em local fresco e seco DE An einem kühlen und trockenen Ort lagern GR Διατηρείται σε δροσερό και στεγνό περιβάλλον
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IT Codice prodotto GB Product code FR Code produit ES Código producto PT Código produto DE Erzeugniscode GR Κωδικός προϊόντος
IT Numero di lotto GB Lot number FR Numéro de lot ES Número de lote PT Número de lote DE Chargennummer GR Αριθμός παρτίδας
IT Dispositivo medico GB Medical Device FR Dispositif médical ES Producto sanitario PT Dispositivo médico DE Medizinprodukt GR Іατροτεχνολογικό προϊόν
IT Dispositivo medico conforme al regolamento (UE) 2017/745 GB Medical Device compliant with Regulation (EU) 2017/745 FR Dispositif médical conforme au règlement (UE) 2017/745 ES Producto sanitario conforme con el reglamento (UE) 2017/745 PT Dispositivo médico em conformidade com a regulamento (UE)
2017/745
DE Medizinprodukt im Sinne der Verordnung (EU) 2017/745 GR Ιατρική συσκευή σύμφωνα με την ΚΑΝΟΝΙΣΜΌΣ (ΕΕ) 2017/745
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Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
Made in Pakistan
M26544-M-Rev.7-09.21
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