141364

Nom de l'organisation

AKTORmed GmbH

SRN

DE-MF-000006136

Statut du fabricant

Actif

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

• CW999

  The SOLOASSIST II may not be used for fields other than the application fields named above. The SOLOASSIST II may be used exclusively for holding and moving an endoscope.
• CW999

  Devices that are connected to the analogue and digital interfaces of the SOLOASSIST II must comply with the standards for electromedical devices. All configurations must meet the requirements of the system standard EN 60601-1. The person connecting additional devices is responsible for the compliance with this standard!
• CW999

  Never use the SOLOASSIST II if you detected any damage. Contact the corresponding service.
• CW009

  STERILE COVER - Do not reuse
• CW999

  The device is not intended for the operation in explosive areas. Ensure a sufficient distance to highly flammable gases (e.g. O2, anaesthetic gases).
• CW999

  The SOLOASSIST II or the associated POWER SUPPLY may not be placed directly adjacent to other equipment or stacked with other equipment. If it is necessary to operate the device close to other equipment and stacked with other equipment, the SOLOASSIST II should be monitored in order to check the proper operation with this arrangement.
• CW999

  Use only the original STERILE COVER which you have bought from the manufacturer or an authorised partner
• CW999

  In case of intraoperative complications not due to the use of the SOLOASSIST II, it may still be in order to remove the device as fast as possible from the OR surroundings in order to have better access to the patient.

Marché principal en Autriche ; disponible dans 1 pays au total.

Commercialisé en Autriche ; dates par pays non publiées.

Dénomination commerciale

non renseigné

Code d'UDI-DI

04260463843644

Basic UDI-DI

4260463840018T

Numéro de référence/catalogue

141364

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

incl. POWER SUPPLY, POWER CORD C7 and SUPPLY CABLE

URL des informations complémentaires

https://aktormed.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z1202018001ROBOTIC ARMS FOR VIDEOENDOSCOPY

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