13-30-101

Nom de l'organisation

Ganshorn Medizin Electronic GmbH

SRN

DE-MF-000006566

Statut du fabricant

Actif

4 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW273

  Serious injury caused by an electrical shock: –Do not use the device if the protective earth is suspect or if the mains lead/power supply unit isdamaged or suspected of be-ing damaged. –This device may only be connected to a mains supply with protective earth. –Prior to initial operation and daily use, the device has to be inspected for external damage. Danger of electric shock due to ingress of liquid
• CW999

  Danger of ventricular fibrillation triggered by equalising currents between different device potentials. This may be the case if the device is used together with medical devices for direct cardiac application: –Connect both devices to the building's joint potential equalisation.
• CW999

  The device may only be opened by the manufacturer's customer service. If any ambiguities should arise, promptly contact the manufacturer's customer service.
• CW999

  To change fuses, the device must first be disconnected from the power supply voltage. Fuses must only be replaced by trained electricians. Only replace with fuses with the same electrical specifications (250 V T 1.25 A)

Marché principal en Allemagne ; disponible dans 32 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

07613365500738

Basic UDI-DI

7613365SANABYL

Numéro de référence/catalogue

13-30-101

Entité d'attribution

GS1

Catégorie de risque

Classe I

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

A device intended to be used to provide a quantitative measurement of the rate at which work (energy) is performed by a muscle or group of muscles under controlled conditions. It is operated by a person using their legs, usually the patient, undergoing assessment, treatment, training and measures this related muscle activity at defined workloads. The Ergometer could be used in exercise testing in combination with stress electrocardiography and/or stress echocardiography device.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z129003CYCLES FOR PHYSIOTHERAPY AND/OR DIAGNOSTIC USES

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel