305200001

Dénomination commerciale

non renseigné

Code d'IUD-ID

03663996011855

IUD-ID de base

B-03663996011855

Numéro de référence/catalogue

305200001

Entité d'attribution

GS1

Catégorie de risque

Classe IIb

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

PLACOM is disposable, non-sterile dispersive electrode with or without a pre-attached wire available in a comprehensive range of shapes and sizes (adult and paediatric).

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

• K02010201ELECTROSURGERY SINGLE PATIENT PADS (NEUTRAL ELECTRODES), SINGLE-USE

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

• CW011

  Do not cut or modify the plate. Do not reposition it once applied. Do not add gel. ▪ Avoid all contact between the active cable and the patient's skin. Avoid tangling the cable. ▪ Do not exceed 50W for newborn plates. ▪ Do not use the device if the packaging is damaged or if the expiration date has passed. ▪ Do not use the product if it has been exposed to environmental conditions beyond those specified. ▪ Do not apply the plate over trauma, scars, bony prominences, or in proximity to ECG electrodes. ▪ Do not position the plate over or near metallic implants (e.g., pacemakers or orthopedic prostheses). ▪ Ensure the entire surface of the electrode is properly attached to well-vascularized skin, close to the surgical site. ▪ Do not reuse the product. Reuse may lead to cross-contamination or device failure. ▪ If abnormal operation of the electrosurgical unit is detected (e.g. low output), check the application and connections before increasing power. ▪ The device is not intended for high-current modes. ▪ Stop the procedure if an alarm indicates poor contact or skin injury. ▪ Avoid skin-to-skin contact (e.g. underarms) by inserting dry gauze. ▪ Ensure monitoring and active cables do not contact each other or the patient. ▪ Store unused active electrodes away from the patient. ▪ Regularly inspect accessories and cables for damage.
• CW010

  The device is intended for use on intact skin only. ▪ Prepare the skin by shaving, cleaning and drying the area of application. ▪ Open the pouch and remove the protective film just before use. ▪ Follow the electrosurgical generator’s user manual. ▪ Inspect the cable and device integrity before application. ▪ Apply the electrode firmly from one edge to ensure good adhesion. ▪ Before placing surgical drapes, verify full contact between electrode and skin. ▪ After use, gently remove the electrode from an edge — never pull by the cable. ▪ In case of known allergies to any of the electrode components (see datasheet), do not use the device. ▪ Dispose of the used product in compliance with medical waste regulations. Used products may present microbial hazards.

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

Ce dispositif n'est actuellement lié à aucun autre dispositif.