AccuRay 630R

Dénomination commerciale

non renseigné

08800001600191

B-08800001600191

Numéro de référence/catalogue

AccuRay 630R

GS1

Classe IIb

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

AccuRay 630R irradiates through inverter type according to tube voltage, tube current and exposure time selected by operator. X-ray image is acquired by chemical action generated by intensity, which reaches sensitive material, after generated under the set a fixed quantity of X-ray irradiation conditions and penetrates subject. Acceptable area for examinations are head to toe. This device can be taken in any part of head, spine, chest, abdomen and the others. This device can be used in various positions of the patient, for example, sitting or standing or lying on a separate table. It is used to screen orthopedics, respiratory, or vertebral discs for diagnostic purposes commonly used. And It is not used to fluoroscopy, angiography or mammography. This device must be operated by a user who has met or is properly trained in the requirements of the radiologist. It should be used for pregnant women according to the instructions of the physician. Also, operator should wear themselves and clothe infants in protective device to prevent unnecessary exposure. There is no direct contact on the device with the patient’s body, but because it is a radiation-exposed device, it should be used where radiation protection is possible, such as a hospital’s protected room. It does not apply to sterilization or disposable equipment. This unit is not a measuring and monitoring device that has a performance of diagnosis.

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.

• Z110310MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY

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

• CW999

  AccuRay 630R should not be used if any of the following contra-indications exist. · protection of the embryo or fetus during radiological examination or treatment of women known to be or possibly pregnant · sensitive body organ ; lens of eye, gonads · acute skin burns · acute hair loss · chronic radiation injury