HBH

Dénomination commerciale

HBH

06924464103708

69244641004TE

Numéro de référence/catalogue

EU-PRP(G)-05

GS1

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

3

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.

• B030101APHERESIS PLASMA COLLECTION DEVICES

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

• Ne pas réutiliser

  【Reuse Precautions Statement】 For single patient use only. Do not reuse , reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which ,in turn ,may result in patient injury, illness, or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, transmission of infectious disease(s) from one patient to another .Contamination of the device may lead to injury, illness or death of the patient.

• Ne pas restériliser

  3. This product cannot be repeatedly sterilized and should be used within the validity period of the product.

• Ne pas utiliser si l’emballage est endommagé

  2. This product has been sterilized, and it is prohibited to use it if the package is damaged. 9. Before use, please check the tightness of the preparation tube to ensure that there is no visible damage. If there is damage, the tube may not be in a vacuum state, and the expected blood draw volume will not be achieved. It is recommended not to use it and use a new tube.

• 【General Warnings and Precautions】 1. Please read the product manual carefully before using it. The product should be used by professional medical personnel. 4. This product is disposable and should be disposed of after use according to relevant regulations on medical waste. 5. The prepared PRP is applied to the same patient whose blood is collected. 6. PRP must be prepared from freshly collected blood and used within 2 hours and it needs to be gently and continuously oscillated at a temperature of 20℃~24 ℃ during storage. 7.PRP treatment must be performed by a qualified medical practitioner. Do not give intravenous PRP. Patients must be informed of the general risks and possible adverse effects associated with treatment. The safety and efficacy of PRP in combination with other therapies should be evaluated by a physician. 8. When using a centrifuge, follow the centrifuge manufacturer's instructions. The test tube should be centrifuged as recommended in the instructions for use, with a relative centrifugal force (RCF) of 1500 g. Excess RCF (more than 2200g) can cause a rupture of the pipe, resulting in blood exposure and potentially injury. RCF below 1500 g may result in incorrect blood separation and PRP contamination. The size of the centrifuge carrier and insert should be appropriate to the test tube. Using a carrier that is too large or too small can cause the tube to break. Care should be taken to ensure that the tube is properly secured to the centrifuge carrier. The test tube must be balanced in the centrifuge. 10. Do not use the sodium citrate solution contained in the PRP tube alone or other tube components separately.