PROFESSIONAL MEDICAL PRODUCTS
SPECULUM MONOUSO
DISPOSABLE SPECULUM
SPÉCULUM À USAGE UNIQUE
ESPÉCULO DESECHABLE
ESPÉCULA DESCARTÁVEL
SPECULUM ΜĺΑΣ ΧΡΉΣΕΩΣ
È necessario segnalare qualsiasi incidente grave vericatosi in relazione al dispositivo medico da noi fornito al fabbricante e all’autorità competente dello Stato membro in cui si ha
sede.
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 ofce is
located.
Il est nécessaire de signaler tout accident grave survenu et lié au dispositif médical que
nous avons livré au fabricant et à l’autorité compétente de l’état membre où on a le siège
social.
Es necesario informar al fabricante y a la autoridad competente del Estado miembro en el
que se encuentra la sede sobre cualquier incidente grave que haya ocurrido en relación con
el producto sanitario que le hemos suministrado.
É necessário noticar ao fabricante e às autoridades competentes do Estado-membro onde
ele está sediado qualquer acidente grave vericado em relação ao dispositivo médico fornecido por nós.
Σε περίπτωση που διαπιστώσετε οποιοδήποτε σοβαρό περιστατικό σε σχέση με την ιατρική
συσκευή που σας παρέχουμε θα πρέπει να το αναφέρετε στον κατασκευαστή και στην
αρμόδια αρχή του κράτους μέλους στο οποίο βρίσκεστε.
M31485-M-Rev.5-02.20
31485 - 31486 - 31487 - 31488 - 31491- 31492
31495 - 31496 - 31497 - 31498 - 31499
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
Made in China
Compatibili con / Compatible with / Compatible avec /
Compatibles con / Compatíveis com / Συμβατά με:
- GIMA: Gimalux, Sigma, Sigma C, Visio2000, Visio5
- Heine: Mini 2000, Mini 3000, K180, Beta 200, Beta 400
- Riester: Ri-Mini, Ri-scope L1, Ri-scope L2, E-scope, Pen-scope
- Kawe: Picolight, Combilight F030, Eurolight F030
- Holtex
- Colson
- Luxamed
Montaggio con connettore 31493 / Assembly with connector 31493 /
Monter avec connecteur 31493 / Ensamblaje con conector 31493 /
Montagem com conector 31493 / Συναρμολόγηση με συνδετήρα 31493:
- GIMA: Parker
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The disposable speculum is an accessory for otoscopes for direct examination of the external acoustic
duct and the tympanic membrane.
The product or parts of it cannot be used for purposes different from the one specied in the intended use of the present manual. The product must be used by qualied medical personnel only
in out-patients department. The product is not intended for use in operating rooms.
Use: Choose the size of speculum suitable to the acoustic duct to examine. Insert the speculum into the
otoscope head group and clockwise rotate it. After examining the patient, counter clockwise rotate the
speculum, remove it from it seat and dispose it according to the law in force on the subject of disposal.
Keep out of children’s reach!
Do not reuse the specula!
Do not sterile the specula in autoclave or with disinfectants! After the use, remove the specula
from the otoscope head and throw them away!
ENGLISH
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IT - Numero di lotto GB - Lot number
FR - Numéro de lot ES - Número de lote
PT - Número de lote GR - Αριθμός παρτίδας
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
GR - Ιατρική συσκευή σύμφωνα με την ΚΑΝΟΝΙΣΜΌΣ (ΕΕ) 2017/745
IT - Dispositivo monouso, non riutilizzare
GB - Disposable device, do not re-use
FR - Dispositif pour usage unique, ne pas réutiliser
ES - Dispositivo monouso, no reutilizable
PT - Dispositivo descartável, não reutilizar
GR - Προϊόν μιας χρήσεως. Μην το χρησιμοποιείται εκ νέου
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 GR -
IT - Codice prodotto GB - Product code
FR - Code produit ES - Código producto
PT - Código produto GR - Κωδικός προϊόντος
IT - Fabbricante GB - Manufacturer
FR - Fabricant ES - Fabricante
PT - Fabricante GR - Παραγωγός
IT - Non sterile GB - Non-sterile
FR - Pas stérile ES - No estéril
PT - Não estéril GR -
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
GR - Προσοχή: διαβάστε προσεκτικά τις οδηγίες (ενστάσεις)
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
GR - Διατηρείται σε δροσερό και στεγνό περιβάλλον
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 GR - Διαβάστε προσεχτικά τις οδηγίες χρήσης
IT Dispositivo medico GB Medical Device
FR Dispositif médical ES Producto sanitario
PT - Dispositivo médico GR - Іατροτεχνολογικό προϊόν
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