N1

Dénomination commerciale

N1

08800000995809

B-08800000995809

Numéro de référence/catalogue

N1

GS1

Classe IIb

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

N1 is a dental portable X-ray imaging system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use N1 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children. - N1 is a portable dental X-ray imaging device powered by a rechargeable lithium polymer battery pack. It generates X-rays optimized for dental examinations (on teeth, etc.). N1 is a product designed to diagnose the conditions of teeth through X-irradiation using its intraoral imaging sensors. The N1's X-ray generator equipped with an X-ray tube consists of control unit, user interface, X-ray aperture (collimator), a back-scatter shielding glass, remote irradiation switch, mount block kit and tripod. This device is used by fixing it to a mount block kit and tripod.

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.

• Z1103040102EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY

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

• CW999

  Caution ① If the safety rules and instructions for use are not complied with, the X-ray device can be very harmful to the human body. Make sure to understand and follow the guidelines in the warnings and cautions contained in the user manual. ② To avoid a risk of electric shock, make sure to connect a protective earth to the X-ray tube assembly device.
• CW999

  [Warning] For using the device ① This device can be very dangerous when used in an explosive atmosphere. Be careful not to place flammable materials around. ② Be careful not to make it come into contact with water, moisture, or foreign objects. Contact with water or moisture may cause an electric shock or device damage. ③ Do not touch the patient while touching the signal input/output connector. ④ The occupied area is a floor area of 60 cm x 60 cm and a height of 200 cm or more.
• CW999

  [Warning] Cleaning ① Always turn off the power before cleaning the device. ② Never use a wet towel or spray liquid for cleaning the device. Applying liquid may cause an electric shock or equipment damage. ③ Do not sterilize the device using a spray. Sprayed disinfectant may cause an ignition.