PROSTAR

Dénomination commerciale

non renseigné

08800001611302

B-08800001611302

Numéro de référence/catalogue

PROSTAR

GS1

Classe IIb

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The PROSTAR is the equipment which intended to be used as diagnosis purpose by using radiography and fluoroscopy with image intensifier and CCD, and it provides digital image to end user. It usually used in a general hospital, small scale of hospital, and local clinic. As mentioned from above, this unit primarily used for diagnosis of diseases in internal physics and skeletal orthopedic system such as skull, spinal column, chest, abdomen, extremities, and other body parts. Especially it is intended for usage of normal radiography and fluoroscopy, and AEC mode in DR. To define a set of system reliability/maintainability of performance, and specifications that will provide the basis for PROSTAR configuration and the design verification. It cannot use for Angiography, Radio-frequency cardiac catheter ablations, Transjugular intrahepatic portosystemic shunt (TIPS), Embolizations, Cardiac and non-cardiac vascular reconstructions due to its characteristics of output (2.2kW). This device is not intended to use for paediatric applications. PROSTAR is controlled with microprocessors, and then it is very easy to operate.

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.

• Z11039009FLUOROSCOPY DEVICES

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

• CW999

  The contraindication of this device are as follows. When diagnosing the following patients, operator should consult with doctor before proceeding. - Pregnant woman - Patient using implantable cardiac pacemaker - Infants and Toddlers (Radiologist uses irradiation conditions according to clinical conditions when diagnosing infants.)