Socket adapter 4А47Р

Dénomination commerciale

Socket adapter 4А47Р

04820304200335

482030420SOCKETPYRAC

Numéro de référence/catalogue

Socket adapter 4А47Р

GS1

Classe I

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The 4A47P socket adapter is intended to connect the distal components of a lower-limb prosthesis to the residual-limb socket. The base section is manufactured from an aluminium alloy. The device is intended exclusively for external lower-limb prosthetic applications. It is recommended for mobility level 1 (indoor walking), mobility level 2 (limited outdoor walking), mobility level 3 (unrestricted outdoor walking), and mobility level 4 (unrestricted outdoor walking with particularly high demands). The maximum permitted body weight is 125 kg. The distal connection is designed as an adjustment pyramid.

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.

• Y062499LOWER EXTREMITY PROSTHESES - OTHER

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• Do not use the device for users weighing more than 125 kg or for mobility levels outside those specified by the manufacturer. The adapter must be installed, aligned, tightened, and inspected only by a qualified prosthetist and used exclusively with compatible prosthetic components. Incorrect assembly, incompatible components, improper alignment, or insufficient tightening may result in loosening, instability, component failure, or falls. Do not use the device if the adapter, base section, adjustment pyramid, or connected components are cracked, deformed, corroded, loose, damaged, or excessively worn. Any unusual movement, noise, instability, pain, or change in prosthetic function requires immediate inspection by a qualified healthcare professional. The device must not be modified or used for any purpose other than lower-limb exoprosthetic fitting.

  AUTRE