SLH 3XC LED - REF

Dénomination commerciale

SLH 3XC LED - REF

05055272717113

50552727SLITLAMPSRG

Numéro de référence/catalogue

3020-P-2089

GS1

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.

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

• Z12120108SLIT LAMPS

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

• Avertissement

  • Use only genuine Keeler approved parts and accessories or device safety and performance may be compromised. • It is vital that the binoculars are optimised for the user’s optical correction in order to obtain focused binocular images. • Parts of the slit lamp coming in to contact with the patient should be cleaned in accordance with these instructions prior to the examination. Keeler recommends the use of disposable hygienic chinrest tissues on the chinrest before the patients place their chin on it.

• Prudence, risque de choc électrique

  • The power switch and mains plug are the means of isolating the device from the mains supply - ensure both the power switch and mains plug are accessible at all times. • Do not position the equipment so that is diffi cult to press the power switch or remove the mains plug from the wall socket. • The refraction stand, combi unit or table leg must be IEC 60601-1 compliant • Only a hospital grade 3-conductor electrical power supply cable must be used. For USA and Canada: Detachable power supply cord set, UL listed, type SJE, SJT or SJO, 3-conductor, not smaller than 18 AWG. Plug, cable and ground lead connection of the socket have to be in perfect condition. • Do not touch accessible connectors and the patient simultaneously. • After removal of the LED, do not touch the Slit Lamp LED electrical contacts and patient simultaneously. • Before any cleaning of the instrument or the base unit, ensure the power lead is disconnected.

• Avertissement; Rayonnement optique

  • CAUTION: The light emitted from this instrument is potentially hazardous. The longer the duration of exposure, the greater the risk of ocular damage. Exposure to light from this instrument when operated at maximum intensity will exceed the safety guideline after 171 seconds. • While no acute optical radiation hazards have been identified for slit lamps, we recommend keeping the intensity of the light reaching the patient’s retina to the minimum possible for the respective diagnosis. • Children, people with aphakia and people suffering from eye conditions are most at risk. An increased risk may also occur if the retina is exposed to the same or a similar device with a visible light source within 24 hours. This applies, in particular, if the retina has been photographed with a flashbulb in advance. • Keeler Ltd shall on request, provide the user with a graph showing the relative spectral output of the instrument.