Kiwi® OmniCup® Fetal Vacuum Extractor
Regulatory Class: Medical Device
Introduction: The Clinical Innovations’ Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator.
Indications for Use: Standard Vacuum Assisted Delivery– Use for vacuum assisted fetal delivery in conditions of 1) prolonged second stage of labor (arrest of descent) where fetopelvic relationships are adequate, 2) presumed fetal jeopardy which is not considered to be severe, or 3) elective shortening of the second stage for selected maternal or fetal conditions. Abandonment of a vacuum delivery should be considered1) if no descent (progress) of the head occurs after 2 tractions, 2) if delivery is not achieved or imminent after 4 tractions, or 3) if the vacuum cup detaches (“pops-off”) twice
Contraindication:
Standard Vacuum Assisted Delivery:
1) Arrest of descent where fetopelvic relationships are considered to be inadequate,
2) unengaged presenting part
3) All non-vertex presentations (breech, face, brow, transverse lie)
4) Nonruptured membranes
5) Incomplete cervical dilation and effacement
6) Extreme prematurity
7) Known fetal coagulopathies or bone demineralization disorders.
Special Precautions:
1) Gestational age less than 36 weeks or estimated fetal weight (EFW) less than 2500 grams
2) Previous scalp sampling
3) Scalp damage
4) Failure of efforts after 20 minutes
5) Delivery requiring unusual amounts of traction force (>25 lbs/12kgs)
6) Suspected macrosomia
Adverse Events:
Fetal Injuries: cephalohematoma, subdural, subgaleal hemorrhage, intraventricular, or parenchymal hematoma, subconjunctival, intracranial, or retinal hemorrhage, nerve injuries, subjective jaundice, elevated bilirubin, bruises, contusions, lacerations, fractures. Maternal Injuries: Vaginal, cervical, uterine, bladder, rectal.
Presentation/ Packaging: 1 each per pouch and 5 pouches per box
For more information, please see full product information.
