3.6V PRACT / FO DIAGNOSTIC SET

Dénomination commerciale

3.6V PRACT / FO DIAGNOSTIC SET

05055272719988

5055272745084XR

Numéro de référence/catalogue

1729-P-1024-500

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.

• Z12120199OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER

13 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. • Backwards compatibility of the LED module has not been tested. • The product has been designed to function safely when at an ambient temperature between +10°C and +35°C. • Do not use Keeler Retinoscopes or Ophtalmoscopes in ambient temperatures above 35°C. • There are no user serviceable parts inside. Contact authorised service representative for further information. • Ensure device is securely held in docking station to minimise risk of injury or damage to equipment. • Follow guidance on cleaning / routine maintenance to prevent personal injury / damage to equipment. • At product end of life dispose of in accordance with local environmental guidelines (WEEE). • Care should be taken when handling halogen bulbs. Halogen bulbs can shatter if scratched or damaged. • Care should be taken when fitting heads to handles not to trap skin between parts. • Please ensure that the control is in the off position when the examination has been completed. • The product and the ear specula are supplied non-sterile. Do not use on injured tissue. • Use new or sanitised specula to limit the risk of cross-contamination. • If the plastic tip of the Otoscope is not replaced or cleaned properly, infection can spread from one ear to the other. • The disposal of used ear specula must occur in accordance with current medical practices or local regulations regarding the disposal of infectious, biological medical waste.

• Prudence, risque de choc électrique

  • Do not fit mains power adapter into a damaged mains outlet socket. • 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. • To isolate the equipment, disconnect from the mains or switch off at the mains. • Do not position the equipment so that is difficult to press the power switch or remove the mains plug from the wall socket. • Do not touch the terminal contacts of the charging dock or hand unit, or the terminal contacts and the patient simultaneously. • Switch off the electrical supply and disconnect from the mains electrical supply before cleaning and inspection. • After removal of the bulb / LED do not touch the bulb / LED contacts and the patient simultaneously. • After removal of the battery do not touch the battery contacts and the patient simultaneously. • Always ensure that the handle rheostat is turned off before fitting an instrument head or changing a bulb. • When replacing rechargeable cell, turn handle off and insert new cell. Replace bottom cap, and place handle into charging well.