Sinapi Chest Drain

Dénomination commerciale

Sinapi Chest Drain

06009900390215

60099003867SCDW5

Numéro de référence/catalogue

XL2000SD

GS1

Classe I

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The SINAPI Chest Drain (SCD) is a non-invasive medical device that is connected to any inserted chest catheter. It is a sterile, single use device, intended to drain fluid from the thoracic cavity.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

1 niveau de conditionnement enregistré — chaque niveau porte son propre IUD-ID.

• 06009900390215× 1 unitéUnité de base
  • 16009900390212× 1 unité

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

• A060203PLEURAL DRAINAGES WITH VALVE AND KITS

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

• Ne pas restériliser

  Do not resterilize

• Ne pas réutiliser

  Single use only

• Ne pas utiliser si l’emballage est endommagé

  Do not use if package is damaged

• Avertissement

  1.This device is only intended for use by appropriately trained personnel. 2. Do NOT remove the connector - it contains the high negativity vent. 3. The tube roller must ONLY be used in conjunction with a high negativity vent, fitted in the connector. 4.Compatibility of the Sinapi Chest Drain with thoracic catheters needs to be established by the user. 5. Assess the thoracic catheter connections for signs of an air leak. 6. Thoracic catheter dressings should be occlusive. 7. Ensure that there are no dependent loops or kinks in the patient drainage tube. 8. Little or no drainage may indicate a blockage in the drainage system 9. Do not keep the tube clamped during chest drainage or patient transport, this will inhibit drain operation and may compromise respiratory function of patient. 10. Samples of the drained fluid can be taken directly from the needle-free sampling port located on the front of the device. 11. When using suction control, keep device upright to prevent fluids entering suction regulator. 12. Discontinue use and replace with a new unit if body fluids entered the suction regulator. 13. Observing Universal Precautions, discard the SCD in a medical waste container, in accordance with the Waste Management policy of the health care facility. 14. NOTE: Any serious incident that occurs in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.