T2

Dénomination commerciale

T2

08800000995618

B-08800000995618

Numéro de référence/catalogue

T2-CS

GS1

Classe IIb

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

“T2-CS”, a dental radiographic imaging system, consists of three image acquisition modes; panoramic, cephalometric and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, “T2-CS” are a complete dental X-ray system equipped with X-ray tube, generator and dedicated detector for dental panoramic, cephalometric and cone beam computed tomographic radiography. The dental CBCT system is based on digital X-ray detector. CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic and cephalometric dental X-ray system based on X-ray detector.

URL des informations complémentaires

https://ifu.osstem.com/ifu/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

• Z11030607COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE

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

• CW999

  [Warning]Laser Beam ① This equipment features a Class 1 laser device. The laser beam should not be used for any purposes other than aligning the patient. ② Make sure the patient does not look directly into the laser beam. ③ Be careful not to expose the patient’s eyes to the laser beam. ④ Even minimal exposure to the laser beam could cause permanent damage to optic nerve.
• CW999

  [Warning] Cleaning ① Do not use a wet towel or spray when cleaning this equipment. Electric shock or equipment damage may occur. ② Do not sterilize using sprays. Spray-type disinfectants may ignite fire.
• CW999

  [Warning] When using the equipment ① Keep flammable materials away from this equipment. Combustion may occur should flammable materials be present. ② Do not use the PC while the equipment is in operation. Equipment malfunction may occur.
• CW999

  [Warning] Radiation ① The equipment must be installed in an X-Ray shielded room that meets radiation safety regulations. ② The user should perform imaging outside of the shielded room and must maintain visual contact with the patient at all times during imaging. The user should be able to recognize and immediately address an emergency situation. ③ If the equipment shows signs of abnormal operation, the user should turn OFF the power or press the emergency button to stop the imaging. ④ Children and pregnant Woman must consult with a doctor before X-Ray exposure. ⑤ When imaging a patient, a lead apron is mandatory for radiation protection purposes. In particular, children and pregnant Woman must wear a lead apron when being imaged. ⑥ The amount of X-Ray radiation is reversely proportional to the distance of equipment and human. So do not allow anyone other than the patient to enter the shielded room without radiation protection.