3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT TRITON

Nom de l'organisation

SRN

JP-MF-000003928

Statut du fabricant

Actif

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

• This instrument must not be used for the following patients: - Patients who are hypersensitive to light. - Patients who recently underwent photodynamic therapy (PDT). - Patients taking medication that causes photosensitivity

  AUTRE

• - Be careful not to hit the patient's eyes or nose with the instrument during operation. The patient may be injured. - Modification of this instrument is not permitted. Modifying the instrument may cause people to be injured, make the burden on the human body, lower the reliability of the measurement results, or cause the devices to malfunction.

  AUTRE

• Avertissement; Électricité

  To avoid fire and electric shock, install the instrument in a place free of water and other liquids. To avoid fire and electric shock, do not put cups or vessels containing liquids near the instrument. To avoid fire in the event of an instrument malfunction, immediately turn OFF (○) the Power switch and unplug the cable if you see smoke coming from the instrument or if you detect other problems. Don't install the instrument where it is difficult to unplug the cable from the instrument body. Ask your dealer for repairs. To avoid electric shock and fire, do not disassemble. Modify or repair the equipment. Ask your dealer for repairs. To avoid electric shock, do not open the instrument. Request service from an authorized Topcon distributor. To avoid fire and electric shock in case of leakage, be sure to use a power supply equipped with a 3-pin plug AC receptacle for proper grounding. To avoid damage to the instrument or injury due to an electric shock, turn off the power switch and remove the power cord before cleaning the instrument. To avoid electric shock, do not attempt disassembling, rebuilding and/ or repairs on your own. Ask your dealer for repairs. Do not remove the covers from the main unit, chinrest unit or power supply unit except for the lamp house cover. You may receive an electric shock. Do not remove the covers from the main unit except for the lamp house cover. Your eye or skin may be exposed to the laser radiation.

Marché principal en Pays-Bas ; disponible dans 2 pays au total.

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

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

• Z12120121OPTICAL CONSISTENCY TOMOGRAPHS

• Dispositifs médicaux de Classe IIa dans EUDAMED

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