Gima 98602, 25662 User guide

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ITALIANO
PROFESSIONAL MEDICAL PRODUCTS
ISTRUZIONI D'USO INSTRUCTION FOR USE MODE D’EMPLOI INSTRUCCIONES DE USO INSTRUÇÕES DE UTILIZAÇÃO GEBRAUCHSANWEISUNG
ΟΔΗΓΊΕΣ ΧΡΗΣΗΣ INSTRUKCJA UŻYTKOWANIA INSTRUCȚIUNI DE UTILIZARE
INGLESE
Description
The anti-fog face shield. is composed of a piece of PET lm with a piece of protection lm, a foam support and an elastic band. Indication for U e: The anti-fog face shield is used to help protect the who e face against potential contamination from blood pathogens, body uids, or harmful chen1ical splash during inspection or treatment.
Contraindications:
None.
Product side effects:
This product has no side effects.
Warning:
1. Exposing m high humid envirom11ent may cause losing efficacy of anti-fog effect
2. Suspension of use in case of damage or slackness during use.
3. During use, please try not to touch the center of the lens.
4. Materials that may come into contact with the wea1er1s skin could cause allergic reactions in sensitive individuals.
Operation:
Step l: Remove the inner protective lm. Step 2: Pull the elastic band and put on the head
Storage:
store product in a dry p1ace at 0 - 30°C. Keep away from sunlight
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies
Expiration date
Lot number
Date of manufacture
Medical Device compliant with Regulation (EU) 2016/425
Manufacturer
Product code
Disposable device, do not re-use
Don’t use if package is damaged
Keep away from sunlight
Keep in a cool, dry place
Authorized representative in the European community
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98602 (Gima 25662)
Zhejiang Wellong Medical Technology Co., Ltd. Lvshan Industrial area, Changxing Country, Huzhou City, Zhejiang Province, R.P.C. MADE IN CHINA
DPI CE di Cat. II rilasciato da:
DIN CERTCO Gesellschaft ftir Konformitätsbewertung mbH (Organismo Noticato 0196) Alboinstraße 56, 12103 BERLINO, GERMANIA ai sensi dell'Allegato II del Regolamento (UE) 2016/425 - Standard armonizzato EN 166:2001
CE PPE Cat.II issued by:
DIN CERTCO Gesellschaft für Konformitätsbewertung mbH (notied body
0196) Alboinstraße 56, 12103 BERLIN, GERMANY according to the Annex II of regulation (EU) 2016/425 - Harmonized EN 166:2001
CE EPI Cat.II délivrée par:
DIN CERTCO Gesellschaft ftir Konformitätsbewertung mbH (organisme Notié 0196) Alboinstraße 56, 12103 BERLIN, ALLEMAGNE conformément à l’Annexe II du règlement (UE) 2016/425 - la norme harmonisée EN 166:2001
CE PPE Cat.II emitido por:
DIN CERTCO Gesellschaft ftir Konformitätsbewertung mbH (Organismo Noticado 0196) Alboinstraße 56, 12103 BERLÍN, ALEMANIA según el Anexo II del Reglamento (UE) 2016/425 - Armonizado EN 166:2001
EPI CE Cat. II emitido por:
DIN CERTCO Gesellschaft ftir Konformitätsbewertung mbH (Organismo Noticado 0196) Alboinstraße 56, 12103 BERLIM, ALEMANHA de acordo com o Anexo II do Regulamento (UE) 2016/425 - Diretiva 2001/95/CE EN 166:2001 harmonizada
CE PPE Kat.II ausgestellt von:
DIN CERTCO Gesellschaft ftir Konformitätsbewertung mbH (Notied Body
0196) Alboinstraße 56, 12103 BERLIN, DEUTSCHLAND gemäß Anhang II der Verordnung (EU) 2016/425 - harmonisierte EN 166:2001
Έκδοση CE ΜΑΠ Κατ.II από:
DIN CERTCO Gesellschaft ftir Konformitätsbewertung mbH (Notified Body 0196) Alboinstraße 56, 12103 BERLIN, GERMANY σύμφωνα με το Παράρτημα II του Κανονισμού (ΕΕ) 2016/425 - Εναρμονισμένο πρότυπο EN 166:2001
CE PPE Kat.II wystawiony przez:
DIN CERTCO Gesellschaft ftir Konformitätsbewertung mbH (Jednostka notyfikowana 0196) Alboinstraße 56, 12103 BERLIN, NIEMCY zgodnie z załącznikiem II Rozporządzenia (UE) 2016/425 - Zharmonizowanego z EN 166:2001
CE PPE Cat.II eliberat de către:
DIN CERTCO Gesellschaft ftir Konformitätsbewertung mbH (Notified Body
0196) Alboinstraße 56, 12103 BERLIN, GERMANY în conformitate cu anexa II la Regulamentul (UE) 2016/425 - armonizat EN 166:2001
Importato da/Imported by/Importé par/Importado por/Importado por/ Eingeführt von/Importowane przez/Εισαγωγή από/Importat de:
Gima S.p.A. Via Marconi, 1 - 20060 Gessate (Mi) - Italy gima@gimaitaly.com - export@gimaitaly.com www.gimaitaly.com
Dichiarazione di conformità scaricabile al seguente link/Declaration of conformity downloadable at the following link:/Déclaration de conformité téléchargeable au lien suivant/Declaración de conformidad descargable en el siguiente enlace/Declaração de conformidade disponível para download no seguinte link/ Konformitätserklärung unter folgendem Link herunterladbar/ Deklaracja zgodności do pobrania pod poniższym linkiem/Δήλωση συμμόρφωσης με δυνατότητα λήψης στον παρακάτω σύνδεσμο/ Declarația de conformitate poate fi descărcată de la următorul lin https://www.gimaitaly.com/
M25662-M-Rev.0-05.22
Shanghai International Trading Corp. GmbH (Europa) Eiffestrasse 80, 20537, Amburgo, Germania
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