Nom de l'organisation

TOPCON CORPORATION

SRN

JP-MF-000003928

Statut du fabricant

Actif

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

• [Ensuring the Safety of Patients and Operators] Because prolonged intense light exposure can damage the retina, the use of the device for ocular examination should not be unnecessarily prolonged, and the brightness setting should not exceed what is needed to provide clear visualization of the target structures. The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time. If the value of radiance were reduced in half, twice the time would be needed to reach the maximum exposure limit. While no acute optical radiation hazards have been identified for direct or indirect ophthalmoscopes, it is recommended that the intensity of light directed into the patient's eye be limited to the minimum level which is necessary for diagnosis. Infants, aphakes and persons with diseased eyes will be at greater risk. The risk may also be increased if the person being examined has had any exposure to the same instrument or any other ophthalmic instrument using a visible light source during the previous 24 hours. This will apply particularly if the eye has been exposed to retinal photography. Equipment is not suitable for use in the presence of a Flammable Anesthetic Mixture with Air, Oxygen or Nitrous Oxide. The Topcon SL-D301 has no special protection against harmful ingress of water or other liquids (classified IPX0). To avoid damage to the instrument and cause a safety hazard, the cleaning solutions, including water, should not be directly applied to the device. Using a dampened cloth (without dripping), is a good method to clean the exterior surface of the enclosure.

  AUTRE

• Avertissement; Électricité

  [Preventing Electric Shock and Fire] To avoid electric shock and fire, do not disassemble, modify or repair the equipment. Ask your dealer for repairs. To avoid fire in the event of an instrument malfunction, immediately turn off the power switch and remove the power plug from the outlet if you see smoke coming from the instrument or if you detect other problems. Don't install the instrument where it is difficult to disconnect the power plug from the outlet. Ask your dealer for repairs. Be sure to connect the power plug to an AC 3-pin receptacle equipped with grounding. Connection to a receptacle without grounding may cause fire and electric shock in the case of shortcircuiting

• [Ensuring the Safety of Patients and Operators] Use this instrument carefully on the following patients. • Patients who have epidemic corneitis, conjunctivitis or any other infectious disease. • Patients who are taking medications that cause light hypersensitivity. To avoid injury to the patient’s eye and nose, pay particular attention while operating the instrument body. (The patient may be injured.) The Topcon SL-D301 is a medical device. The software and hardware has been designed in accordance with U.S., European and other international medical device design and manufacturing standards. Unauthorized modification of the Topcon SL-D301 software or hardware, or any addition or deletion of any application in any way can jeopardize the safety of operators and patients, the performance of the instrument, and the integrity of patient data.

  AUTRE

Marché principal en Pays-Bas ; disponible dans 32 pays au total.

Dénomination commerciale

SLIT LAMP SL-D301

Code d'IUD-ID

ID primaire

L'ID primaire est l'IUD-ID principal qu'un fabricant désigne comme identifiant de référence d'un dispositif dans EUDAMED.

04562123289572

IUD-ID de base

IUD-ID de base

L'IUD-ID de base est l'identifiant principal qui regroupe toutes les variantes d'un même modèle de dispositif — la clé de la « famille » réglementaire.

4560126260100TU

Numéro de référence/catalogue

SL-D301

Entité d'attribution

Entités d'attribution IUD

Les entités d'attribution sont les organismes que la Commission européenne a désignés pour attribuer les identifiants uniques des dispositifs au titre du système IUD de l'UE.

GS1

Catégorie de risque

Classes de risque RDM

Les classes de risque du RDM classent les dispositifs médicaux du risque le plus faible (classe I) au plus élevé (classe III), ce qui détermine le niveau de contrôle réglementaire.

Classe I

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

—

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• 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.

• Z12120108SLIT LAMPS

• Dispositifs médicaux de Classe I dans EUDAMED

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