Lamination adapter 4А45

Dénomination commerciale

Lamination adapter 4А45

04820304200540

482030420SOCKETMOD83

Numéro de référence/catalogue

Lamination adapter 4А45

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 4A45 lamination adapter is intended for integration into a prosthetic socket by means of lamination. It provides a secure connection between the residual-limb socket and the 4A31 socket adapter and forms a stable interface for the subsequent modular assembly of the prosthesis. 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 consists of four M6 threaded holes.

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 laminated, installed, aligned, tightened, and inspected only by a qualified prosthetist and used exclusively with compatible prosthetic components, including the 4A31 socket adapter. Incorrect lamination, insufficient structural integration into the socket, improper screw engagement, incompatible components, or inadequate tightening may result in loosening, structural failure, instability, or falls. Do not use the device if the adapter, threaded holes, fastening elements, or surrounding laminate is 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.

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