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PROFESSIONAL MEDICAL PRODUCTS
GB -
USER MANUAL FOR REUSABLE SURGICAL INSTRUMENTS
instruments are intended to be used by medical practitioners who are
specially trained on how to use and care of them. The incorrect use, poor or
inappropriate 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 cleaning use only washing equipment with approved and certified detergents. For manual 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 complete-
These
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ly demineralised water in the nal 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 acids or
other aggressive disinfectants that could corrode it. The recommended method
of sterilisation is that of autoclave steam, the temperature of the cycle must not
exceed 135°C (275°F) for a maximum of 15 minutes, to avoid damage to the
product. 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 specic measures for drying. The humidity in the container can
cause the instruments to rust. Often bad, and insufcient drying, is due to the incorrect positioning of the load and the use of unsuitable types of cloths for drying.
For hot air sterilisation, it is recommended to have a temperature ranging between 180° and 200°C. The instruments can also be disinfected in washer
disinfectors up to a temperature of 121°C. 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.
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.
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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
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)
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
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 alla Direttiva 93/42/CEE; in accordo alla
MDCG 2020-2, sarà reso conforme al Regolamento (UE) 2017/745, per
cambio classe, entro maggio 2024.
GB Medical Device complies with Directive 93/42/EEC; in accordance
with MDCG 2020-2, they shall be made compliant with Regulation (EU)
2017/745, for change of class, by May 2024.
FR Dispositif médical conforme à la directive 93/42 / CEE; conformément
au MDCG 2020-2, ils seront mis en conformité avec le règlement (UE)
2017/745, par changement de classe, d’ici mai 2024.
ES Dispositivo médico segun a la Directiva 93/42 / CEE; en conformidad
con la MDCG 2020-2, se adecuarán al Reglamento (UE) 2017/745 para
el cambio de clase antes del mes de mayo de 2024.
PT Dispositivo médico em conformidade com a Diretiva 93/42/CEE, de
acordo com a MDCG 2020-2, deverão estar em conformidade com o Regulamento (UE) 2017/745 devido a mudança de classe até maio de 2024.
DE Medizinprodukt gemäß Richtlinie 93/42/CEE; sie werden bis Mai 2024
in Übereinstimmung mit der MDCG 2020-2 konform mit der Verordnung
(EU) 2017/745 für den Wechsel der Klasse gestaltet.
GR Ιατρική συσκευή σύμφωνα με την οδηγία 93/42 / CEE; Σύμφωνα
με το MDCG 2020-2, θα έχουν συμμορφωθεί με τον Κανονισμό (ΕΕ)
2017/745, λόγω αλλαγής κατηγορίας, μέχρι το Μάιο του 2024
93/42/CEE
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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
M26703-M-Rev.7.09.21
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