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PROFESSIONAL MEDICAL PRODUCTS
GB - USER’S GUIDE FOR REUSABLE NON-SURGICAL INSTRUMENTS
Read safe use instructions carefully before use. These 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 in general before and after every
use, it is rec-ommended to clean, dry and sterilise, if required, the instruments. The
device must be cleaned with warm water, disinfected and rinsed if possible with
distilled water. For au-tomated cleaning no particular requirement is requested. For
manual cleaning remove visible dust/spots with disposable cloth/paper, use approved
and certified detergents. Always follow instructions on how to use the detergent. Also
make sure that the product
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does not come into contact with acids or other aggressive disinfectants that could cor-
rode it. Disinfectants must conform the applicable national regulation for disinfectants
(such as FDA Approval, and CE Mark).
Instruments that are not dried could suffer damage by corrosion. Always dry the instruments with lint-free disposable cloths (do not use recycled cloths). If sterilization is required, European Standard ISO 17665 i.e. Steam Sterilization for Medical Devices is to
be followed. Sterilization is achieved by exposing products to saturated steam at high
temperatures (121°C to 134°C). Product(s) are placed in device called the autoclave
and heated through pressurized steam to kill all microorganisms including spores. The
device’s exposure time to steam would be anywhere between 3 to 15 minutes.
Examples of minimum temperatures and times established for adequate level of microbial lethality in sterilization processes (refer table – 1 of ISO/TS 17665-2).
Temperature °C Time Minutes
121 15
126 10
134 03
ilisation cycles, this depends largely on the state of the product. Repeated processing
has minimal effect on the devices; instruments that show signs of corrosion, damage
or crack must be immediately replaced and not to be used. Always perform a visual
inspection for damage or signs of wear; check for smooth functioning of medical device.
It is recommended to store the device in clean and dry condition. 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.
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.
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.
There is no advice about maximum number of ster-
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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 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
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
SA
SA
SA
SA
SA
SA
SA
SA
SA
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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
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
Limite di temperatura
ES
Límite de temperatura
DE
Temperaturgrenzwert
IT
Limite di umidità
ES
Límite de humedad
DE
Feuchtigkeitsgrenzwert
GB
PT
GR
GB
Humidity limit
PT
Limite de humididade
GR
Temperature limit
Limite de temperatura
Όριο θερμοκρασίας
Όριο υγρασίας
FR
FR
Limite d’humidité
Limite de température
SA
SA
SA
SA
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
Made in India
M26581-M-Rev.3-10.21
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