WAW Software V1

Nom de l'organisation

Devroye Instruments SRL

SRN

BE-MF-000034423

Statut du fabricant

Actif

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

• CW999

  Any manipulation of the medical device must be done only after a complete reading of this user manual. The device may only be operated and used by qualified personnel. The device is only intended for the specific use described in this manual. Any unauthorized modification of the medical device is prohibited and will void the manufacturer’s liability. No loss of essential performance due to EMC interference is to be expected with this device. Portable RF communications, including antennas, can affect medical electrical devices. These must not be used closer than 30 cm (12 inches) to any part of the medical device, including cables specified by the manufacturer. The motor blocks supplied with the system must never be sterilized, opened, soaked in alcohol or clean with compressed air. The device should only be used in a dedicated location such as private specialist centers and clinics, hospitals, doctors’ offices. This device has been tested according to the immunity test levels described in EN60601-1-2 for professional environment. For emission CISPR11 Group 1 class A was selected. Pictograms and warning signs on the devices must not be removed! If these signs are removed, the liability of Devroye Instruments is void. Use of this device adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this device and the other equipment sould be observed to verify that they are operating normally. This device must be used with accessories compatible with WAW Duo FUE System. Failure of the device/any part of the device caused by the use of a non-compatible accessory will void the warranty of the complete WAW Duo FUE System.
• CW999

  The following profiles are contraindicated: Patients with soft cranial tissues. Patients with alopecia areata. Patients with frontal fibrosis alopecia.

Marché principal en Belgique ; disponible dans 18 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

05430003362280

Basic UDI-DI

54300033620WDFSystem69

Numéro de référence/catalogue

WAW Software V1

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

The WAW Software, responsible for defining the parameters of functioning (rotation and oscillation movement) of the handpieces and mode (manual, semi-auto, auto or continuous) of the pedal (the Samsung tablet is supplied).

URL des informations complémentaires

https://devroyeinstruments.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• L0318INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE

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