1950

Dénomination commerciale

non renseigné

Code d'IUD-ID

03665930195010

IUD-ID de base

B-03665930195010

Numéro de référence/catalogue

1950

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The O'Bloo reference 1950L is an intensive phototherapy device for the treatment of hyper bilirubinemia (jaundice) in newborns. It is intended for use in maternity wards, intensive care units and neonatal intensive care units. This device is not intended for home use.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• Bilirubin level — 20 MU97

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• Z12080401PAEDIATRIC PHOTOTHERAPY EQUIPMENT

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW011

  It is imperative to equip the newborn with eye protection for infantile phototherapy before any use or exposure to the phototherapy device. Do not look directly at the light source, the blue light emitted by the device can be annoying or dazzling for the users. Never block the ventilation holes of the device to avoid overheating. Never cover the unit while it is in operation. Constantly monitor the patient's temperature. Monitor the bilirubin level of the newborn at regular intervals. Use away from sunlight and other sources of radiation. Do not use in case of fluid disturbance of the newborn and rehydrate the patient after use. Do not use the device, if the actuator is damaged, the cover falls off by its own weight, call MEDIPREMA customer service. Never use alcohol, ether or grease or any other flammable substance. When the unit is stationary, or when an obstacle on the ground blocks the movement, do not push on the unit. It may tip over. Do not dispose of this unit or its components in household waste, but at the nearest authorized disposal center or at a place designated for this purpose in accordance with local regulations.

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.