Related Manuals for Kiwi OmniCup VAC-6000M
Summary of Contents for Kiwi OmniCup VAC-6000M
- Page 1 Complete Vacuum Delivery System with PalmPump INSTRUCTIONS FOR USE VAC-6000M, VAC6000ME...
- Page 2 One Kiwi OmniCup with Palm Pump™. Description 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.
- Page 3 2) Unengaged presenting part, 3) All non-vertex presentations (breech, face, brow, transverse lie), 4) Non-ruptured membranes, 5) Incomplete cervical dilation and effacement, 6) Extreme prematurity, 7) Known fetal coagulopathies. Precautions ACOG Technical Bulletin #154 Nov. 2015: “As with forceps procedures, there should be a willingness to abandon attempts at vacuum delivery if satisfactory progress is not made.”...
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Page 4: Device Description
DEVICE DESCRIPTION The Kiwi vacuum delivery device is an integral unit designed for complete control without an assistant. The PalmPump provides safe and effective vacuum control. The Kiwi system has been designed with the OmniCup for all positions including asynclitic occiput posterior and transverse fetal malpositions. - Page 5 OmniCup (occipitoposterior/transverse positions) Movement of the OmniCup in the birth canal is limited only by the amount of space between the fetal head and mother’s sacrum posteriorly and the side walls of the pelvis laterally. Provided the operator is skilled in the use of this cup, flexing median applications may be achieved consistently in nearly all malpositions of the occiput.
- Page 6 FLEXION POINT Labor Process Enhancement • Correct technique should enhance the normal processes of labor and should not depend on 3 cm traction alone to effect delivery of the baby. • The key is to locate the flexion 3 cm The flexion point is situated on the sagittal suture 3 point and place the vacuum cup cm forward of the posterior fontanelle.
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Page 7: Distance Measurement
Flexion Point Location The flexion point may be located during vaginal examination by identifying the posterior fontanelle and then moving the finger anteriorly a distance of approximately 3 cm along the sagittal suture. The tip of the finger will mark the flexion point. - Page 8 INSTRUCTIONS FOR VAGINAL DELIVERY 1. Open Package 2. Check vacuum by pumping with cup pressed to gloved hand and watching for stable vacuum indicator reading. (One only needs test to 100-200 mm Hg) Cup Insertion 3. Perform vaginal exam to ensure amniotic membranes are ruptured, cervix is completely dilated and to determine fetal station, position, and flexion point location.
- Page 9 Positioning of the Operator The operator should sit on a stool until the head has descended to the level of the pelvic outlet so that traction will be exerted in a downward direction and assist descent of presenting part by maintaining the flexion point on or just behind axis of pelvis.
- Page 10 Kg/cm² kPa mm Hg lb/in² 0.13 0.13 0.27 0.26 0.41 11.8 0.39 0.54 15.7 0.53 9. Discontinue traction between contractions or if an audible hiss is heard, 0.68 19.7 0.66 0.82 23.6 11.6 0.79 signaling loss of vacuum. 0.95 27.0 13.5 0.92 1.03...
- Page 11 Progress The first pull should cause flexion of the head and some descent. By the end of the second pull the head should be on the pelvic floor and with the third pull, delivery of the head should be complete or imminent.
- Page 12 Delivery 1. Release vacuum with release button after delivery of head. 2. Ease cup off the scalp. 3. Complete birth in normal manner. After Delivery 1. Examine baby’s head immediately after birth for scalp injury and note cup application site. 2.
- Page 13 INSTRUCTION FOR CESAREAN DELIVERY OmniCup (Cesarean Section) The Kiwi OmniCup is suitable for cesarean section deliveries. It’s low profile cup is ideal for easy insertion and maneuverability in the confined abdominal space. Preparation 1. Prepare the mother for C-Section according to hospital protocol.
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Page 14: Symbols Glossary
After Delivery • Examine baby’s head immediately after birth for scalp injury and note cup application site. • Inspect scalp regularly if difficulty was experienced to exclude bleeding into the subgaleal space. • Reassure parents that chignon should disappear in a matter of Vacuum hours and that marks from cup Release... - Page 15 Symbol Symbol Description Lot Code Authorized EC Representative Catalog Number Do Not Reuse Sterilized by Irradiation. Sterility Guaranteed Unless STERILE R Package Opened or Damaged. Do Not Resterilize. Consult Instructions For Use Do not use if the product sterile barrier system or its packaging is compromised Caution: Federal (USA) law restricts this device to sale by or on the order of a physician Warning or caution...
- Page 16 Clinical Innovations 747 West 4170 South Murray, Utah USA 84123 P. 801-268-8200 forMOM. forBABY. forLIFE. Clinical Innovations Europe, Ltd. Toll Free: 888-268-6222 6-9 The Square | Stockley Park, Heathrow UB11 1FW | United Kingdom Copyright 2018, Clinical Innovations, LLC. Tel +44 (0) 333 370 4408 clinicalinnovations.com All rights reserved.
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