Double-ended adapter 4А72=32

Dénomination commerciale

Double-ended adapter 4А72=32

04820304200366

482030420DOUBLEALUZ5

Numéro de référence/catalogue

Double-ended adapter 4А72=32

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 4A72=32 double adapter is used to connect two pyramid adapters. The pyramid receivers allow distal and proximal angular adjustments in the frontal and sagittal planes. The adapter has an overall height of 32 mm and a system height of 68 mm and 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 proximal and distal connections are designed as pyramid receivers.

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, adjusted, tightened, and inspected only by a qualified prosthetist and used exclusively with compatible pyramid adapters and prosthetic components. Incorrect angular adjustment, insufficient tightening, or the use of incompatible components may result in loosening, instability, component failure, or falls. Do not use the device if the adapter, pyramid receivers, 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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