Temporary socket adapter РТА01

Dénomination commerciale

Temporary socket adapter РТА01

04820304200571

482030420PANTHERTEMPND

Numéro de référence/catalogue

Temporary socket adapter РТА01

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 PTA01 temporary socket adapter is intended for the preliminary fitting, marking, and alignment of the PANTHER prosthetic foot for strength sports during the manufacture of a lower-limb prosthesis. The adapter is used to determine the optimal spatial position of the prosthetic foot relative to the residual-limb socket and to perform static and dynamic alignment. The device is intended exclusively for external lower-limb prosthetic applications. It is recommended for 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 proximal connection consists of M6 threaded holes, while the distal connection consists of four M6 screws.

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.

• The PTA01 is a temporary fitting and alignment component and must not be used as a permanent structural component of the finished prosthesis unless explicitly approved by the manufacturer. 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 the compatible PANTHER prosthetic foot and approved components. Incorrect assembly, insufficient thread engagement, inadequate tightening, or improper alignment may result in loosening, instability, component failure, or falls. Do not use the device if the adapter, M6 threaded holes, screws, 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.

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