DispoBag, Infant w/Pop-Off, Mask

Dénomination commerciale

DispoBag, Infant w/Pop-Off, Mask

04710810080456

471081008NNL17U

Numéro de référence/catalogue

AR0079

GS1

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Disposable Resuscitator is designed to provide or assist ventilation in patients whose breathing is inadequate.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• infant

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

• 04710810080456× 1 unitéUnité de base
  • 44710810080454× 12 unités

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

• R03020201MANUALLY OPERATED PULMONARY RESUSCITATORS

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• Consulter la notice d’utilisation

  " Intended for use by qualified personnel trained in advanced pulmonary ventilation.  Always test this product for proper function before use on a patient.  Proficiency in the use of this product must be demonstrated before use on a patient. Unfollow the direction of testing before use, common case as below:  Duckbill Valve bonding-The Resuscitation bag can't be pressed and ventilated to the patient.  Duckbill valve damage- the patient does not receive effective treatment.  Intake valve seat hole blocked- the patient does not receive effective treatment.  Oxygen tubing kinked- Unable to deliver oxygen.  Unstable pressure of spring valve or relief valve failure- Higher output pressure to patients- Barotrauma  Damage to the air cushion mask result in air leakage patient cannot receive effective treatment  The Single Patient Use product does not contain any items that can be reprocessed. Not intended to reprocess since it may result in harmful substances entering the human body through the airway.  Without or locked pop-off (pressure relief valve) configuration should be noticed by barotrauma and volutrauma(~5%)  Pressure monitored by attaching the manometer to the resuscitator ensures a safe range if applicable.  Do not administer supplemental oxygen in the presence of fire, spark, or open flame.  Do not use oil, grease, or any hydrocarbon-based substance on any part of the product.  Do not use it in a toxic environment.  If obvious damage or dirt is found on the product inside the package, DO NOT use the device.  The valve plate has noise when using  Mask sealing extent with the face affects the treatment for the patients."