2.5 x 42CM GALILEAN MINI-LOUPE

Nom de l'organisation

SRN

GB-MF-000009031

Statut du fabricant

Actif

6 avertissements enregistrés — faire défiler le panneau pour tout voir.

• P232 - Protéger de l’humidité.

  • To prevent condensation from forming, allow instrument to come to room temperature before use. • For indoor use only (protect from moisture). • This product should not be immersed in fluids. • Under no circumstances should the telescopes be autoclaved or immersed in any form of cleaning fluid.

• P102 - Tenir hors de portée des enfants.

  • Keep out of the reach of children.

• • Please note that the proper and safe functioning of our instruments is only guaranteed if both the instruments and their accessories are exclusively from Keeler Ltd. • Do not use if the product if visibly damaged and periodically inspect it for signs of damage or misuse. • US Federal Law restricts this device to sale by or on the order of a physician or practitioner. • This device is intended to be used only by suitably trained and authorised healthcare professionals. • The manufacturer declines any and all responsibility and warranty coverage should the instrument be tampered with in any manner or should routine maintenance be omitted or performed in manners not in accordance with these manufacturer’s instructions.

  AUTRE

• Ne pas utiliser si l’emballage est endommagé

  • Check your Keeler product for signs of transport / storage damage prior to use.

• Ne pas réutiliser

  • Re-useable flip lever, protective and 1D caps should not be re-used if visibly contaminated with fluids or blood.

• Avertissement

  • Use only genuine Keeler approved parts and accessories or device safety and performance may be compromised. • The product has been designed to function safely when at an ambient temperature between +10°C and +35°C. • The Keeler Loupe and Frame restrict the user’s field and depth of view, forcing them to adopt awkward head-neck postures in order to see clearly. • Failure to carry out recommended routine maintenance as per the instructions in this IFU may reduce the operational lifetime of the product. • There are no user serviceable parts in this instrument. Any servicing or repairs should only be carried out by Keeler Ltd. or by suitably trained and authorised distributors. Service manuals will be available to authorised Keeler service centres and Keeler trained service personnel. • Correctly fitted Loupe can help reduce back and neck pain. Spend a few moments ensuring your Loupes are at the optimal angle to suit you. • Following cleaning and/or sterilisation processes inspect the device to ensure all visible soil has been removed and the device operates as intended and is suitable for its intended use. Do not use if damaged. • The useful life of the device is determined by the wear and damage during use. • Dispose of safely. • At product end of life dispose of in accordance with local environmental guidelines (WEEE).

Marché principal en France ; disponible dans 5 pays au total.

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• Q0299OPHTHALMIC DEVICES - OTHER

• Dispositifs médicaux de Classe I dans EUDAMED

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.