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Kiwi ProCup VAC-6000S Instructions For Use Manual

Complete vacuum delivery system with palmpump

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Complete Vacuum Delivery System
with PalmPump
TM
INSTRUCTIONS FOR USE
VAC-6000S

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Summary of Contents for Kiwi ProCup VAC-6000S

  • Page 1 Complete Vacuum Delivery System with PalmPump INSTRUCTIONS FOR USE VAC-6000S...
  • Page 2 One Kiwi ProCup 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 Contraindications 1) Arrest of descent where fetopelvic relationships are considered to be inadequate, 2) Unengaged presenting part, 3) All non-vertex presentations 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.”...
  • Page 4: 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 ProCup for outlet and low occiput anterior positions.
  • Page 5 ProCup (occipitoanterior presentations) The Kiwi ProCup is suitable for occipitoanterior positions where the flexion point is near the introitus. Maneuverability of the ProCup cup is limited by the rigid cup stem pressing against the labial tissues and perineum. The ProCup cup is maneuvered by pushing the cup in the direction of the flexion point until further movement is inhibited as seen below.
  • Page 6 CUP INSERTION • Perform vaginal exam to ensure amniotic membranes are ruptured, cervix is completely dilated and effaced and to determine fetal station, position, and flexion point location. • Retract perineum with two fingers of non-pulling hand to form a space into which cup is inserted gently in one movement.
  • Page 7 VAGINAL DELIVERY 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 8 Table 2: Equivalent negative gauge pressures Inches cm 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 0.68 19.7 0.66 0.82 23.6 11.6 0.79 0.95 27.0 13.5 0.92 1.03 29.9 1018 14.7 1.00 From: Vacca A. Handbook of Vacuum Extraction. Progress •...
  • Page 9: Symbols Glossary

    observe for potential complications associated with operative vaginal delivery. • Inspect scalp regularly if difficulty was experienced to exclude bleeding into the subgaleal space. • Reassure parents that chignon should disappear in a matter of hours and that marks from cup should leave no traces after a few days. •...
  • Page 10 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 11 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.