ACE Ovum Pickup Needle

Dénomination commerciale

ACE Ovum Pickup Needle

00819374022477

081226101OPN058UV

Numéro de référence/catalogue

A-OVM-SL16/35-M

GS1

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The ACE-M Manual Single Lumen Ovum Pickup Needle is used for laparoscopic or ultrasound-guided transvaginal retrieval of oocytes from follicles, When used with ultrasonic equipment, echo tip enhances visualization, Handle designed for greater control during ovum retrieval, Luer lock connector for connecting a syringe, The amount of suction applied is manually controlled.

URL des informations complémentaires

https://www.allwinmedical.com/e-ifu/

Dimensions cliniques

• 35 MU10
• 16 Gauge

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

• 00819374022477× 1 unitéUnité de base
  • 10819374022474× 10 unités

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

• Z12080202OOCYTE ASPIRATION EQUIPMENT

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

• Ne pas réutiliser
• Ne pas restériliser
• Ne pas utiliser si l’emballage est endommagé
• Ne pas utiliser après la date indiquée
• Contraindications: Ovum pick-up needle should not be used: • In the presence of or after recent pelvic inflammatory disease • For intrafallopian procedures • Active vaginal or intrauterine infection • Sexually transmitted disease • Recent Uterine perforation • Uterine fibroids or other uterine abnormalities • Vaginal bleeding

  AUTRE

• Warning/ Precaution: ● The needle are provided in double sterile pouch packaging, where both pouches serve as sterile barriers. Visually inspect all STERILE barriers before use. Do NOT use the device if any sterile barrier is open, damaged or broken. ● Package Handling: Do not attempt to open the package unless the device is used immediately after opening. Inspect the package before use to ensure it is intact and sterile. If the packaging is damaged or opened prior to intended use, discard the device immediately. ●Compatibility Checks: Before use, ensure the following components are compatible and securely connected: Needle and needle guide of the ultrasound transducer. Vacuum pump and vacuum line hub. Collection tube and silicone bung.Syringe and needle hub. Failure to verify compatibility may result in failure to obtain the required sample and/or tissue damage. Do not use components that are not compatible with this device. • Ultrasound Guidance: Use ultrasound to accurately locate follicles. Failure to do so may result in failure to obtain the required sample and/or tissue damage. In case of difficulty: Manipulate the probe until the follicles appear in close proximity to the needle. If alignment is still not achieved, stop the procedure and assess the positioning of the ultrasound probe and needle. • Malfunction Protocol: In the event of device malfunction or performance issues (e.g., inability to aspirate or visual misalignment): Discontinue the procedure immediately. Check the needle for obstructions, blockages, or visible damage. Reconfirm alignment using ultrasound and reposition the probe as needed. If the issue persists, replace the device with a new sterile unit and restart the procedure. Report any persistent malfunctions to the manufacturer or distributor.