I-ON CXL

Nom de l'organisation

Fidia Farmaceutici S.p.A.

SRN

IT-MF-000026988

Statut du fabricant

Actif

D-SOOFT101YW

La génération de DataMatrix prend en charge les IUD émis par GS1. La prise en charge HIBCC / ICCBBA arrive bientôt.

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• Check the location and meaning of all labels on the equipment

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• Do not damage the connecting cable to the electrodes, and avoid wrapping the cable around the device

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• Do not use the device if the device or its accessories is (are) damaged in any way: contact the manufacturer as described in the "Technical support" section

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• Avoid use in humid environments

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• The user is advised not to wear metal objects during therapy

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• It is forbidden for use on patients with injuries, skin lacerations, dermatitis in the frontal/occipital area

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• Do not use the device on patients with an implanted electronic device without consulting a doctor

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• Simultaneous connection of a patient to an HF surgical device may lead to burns at the stimulator electrodes and the stimulator may be damaged

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• Operating in close proximity (e.g. 1 m) of a short-wave or microwave therapy device can cause instability in the stimulator output

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• Use only electrodes code 4848LE supplied by the manufacturer: different and inadequately sized electrodes may cause skin reactions or burns and compromise the success of the therapy

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• The use of accessories, transducers and cables other than those specified, except for transducers and cables sold by the manufacturer as spare parts for internal components, may result in increased emissions and decreased immunity of the device

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• Do not use the disposable electrode if it is damaged, even if it sticks well on the skin. The electrode is intended for single use only; please refer to the instructions for use in the electrode package

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• It is forbidden to apply the Iontophoresis program in the vicinity of subcutaneous metal synthesis systems (e.g. in the frontal/occipital area)

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• Only use accessories supplied by the manufacturer

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• The manufacturer shall be held responsible for the performance, reliability and safety of the device only if: • any additions, modifications and/or repairs are carried out by authorized personnel; • the device is used in strict compliance with the operating instructions in this manual.

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• It is forbidden to use the device with electrodes placed on parts of the body other than those prescribed in this manual

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• During the iontophoresis procedure, it is advisable to monitor the percentage of the delivered current dose on the display, in case the therapy has to be resumed after switching the device off and on again

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• If the display malfunctions during use, switch off the device and disconnect the patient cable. Repeat the steps in the paragraph “Starting the Iontophoresis Program” and resume the therapy with the remaining current dose. At the end of the procedure, contact the manufacturer in accordance with the “Technical support” section

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• Ne pas utiliser si l’emballage est endommagé
• Consulter la notice d’utilisation

Marché principal en Italie ; disponible dans 10 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.

• Z120604IONTOPHORESIS EQUIPMENT

• Dispositifs médicaux de Classe IIb dans EUDAMED

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

Santé des certificats sur le portefeuille de ce fabricant.