Socket adapter КРВ-16

Dénomination commerciale

Socket adapter КРВ-16

04820304200359

482030420HIPADAPTERFD

Numéro de référence/catalogue

Socket adapter КРВ-16

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 KPV-16 socket adapter is used as a structural component in modular lower-limb prostheses. It is intended for connections used in the installation of a prosthetic hip joint and has a 10° inclination angle. 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 device connections consist of a pyramid receiver and a clamp for a 30 mm tube.

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

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• 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, including an appropriate prosthetic hip joint and a 30 mm tube. Incorrect assembly, improper alignment, insufficient tightening, or the use of incompatible components may result in instability, component failure, or falls. Do not use the device if the adapter, pyramid receiver, tube clamp, 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.

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