Kiwi ProCup VAC-6000S User manual

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

2
KIWI SYSTEM
Contents
One Kiwi ProCup with Palm Pump™.

The Clinical Innovaons’ Kiwi is a disposable vacuum assisted fetal delivery
system. It is a sterile, single-paent-use device designed to provide assistance in
childbirth under the following condions: 1) Term pregnancy, 2) Ruptured amnioc
membranes, 3) Engaged head, 4) Complete cervical dilaon, and 5) Adequately
trained or supervised operator.

Standard Vacuum Assisted Delivery:
Use for vacuum assisted fetal delivery in condions of 1) failure to deliver
spontaneously following an appropriately managed second stage, 2) prolonged
second stage of labor (arrest of descent) where fetopelvic relaonships are
adequate, 3) presumed fetal jeopardy which is not considered to be severe, or 4)
elecve shortening of the second stage for selected maternal or fetal condions.
Trial of Vacuum Assisted Delivery:
Vacuum delivery should be regarded as a “trial” 1) if there is arrest of descent in the
second stage and fetopelvic relaonships are considered to be borderline, or 2) in a
mid-pelvic delivery when the degree of presumed fetal jeopardy is considered to be
more than mild.
Vacuum assisted delivery should be abandoned and birth completed by cesarean
secon 1) if no descent (progress) of the head occurs aer 2 tracons, 2) if delivery
is not achieved or imminent aer 4 tracons, or 3) if the vacuum cup detaches
(“pops-o”) twice.

3

1) Arrest of descent where fetopelvic relaonships are considered to be inadequate,
2) Unengaged presenng part, 3) All non-vertex presentaons 4) Non-ruptured
membranes, 5) Incomplete cervical dilaon and eacement, 6) Extreme
prematurity, 7) Known fetal coagulopathies.

ACOG Technical Bullen #154 Nov. 2015: “As with forceps procedures, there should
be a willingness to abandon aempts at vacuum delivery if sasfactory progress is
not made.”

1) Gestaonal age less than 37 weeks or esmated fetal weight (EFW) less than
2500 grams, 2) Previous scalp sampling, 3) Scalp damage, 4) Failure
of eorts during prolonged period aer properly assessed placement,
5) Delivery requiring unusual amounts of tracon, 6) Suspected macrosomia.
Adverse Events
Fetal Injuries: cephalhematoma, subdural, subgaleal, intraventricular, or
parenchymal hematoma, subconjuncval, intracranial, or renal hemorrhage, nerve
injuries, subjecve jaundice, elevated bilirubin, bruises, contusions, laceraons,
fractures.
Maternal Injuries: So ssue injuries, episiotomy extensions.
Warnings
Limit use to trained, experienced, or supervised operators. Inseron should
be performed carefully, using asepc technique. Forced inseron may result in
malfuncon, paent discomfort, or paent/fetal trauma.



4
The Kiwi vacuum delivery device is an integral unit designed for complete control
without an assistant. The PalmPump provides safe and eecve vacuum control.
The Kiwi system has been designed with the ProCup for outlet and low occiput
anterior positions.
These instrucons are not meant to replace established hospital protocol.
PalmPump™
The PalmPump puts complete control in
the hands of a single operator and frees
up delivery room personnel.
The PalmPump’s integral design provides:
• A simple hand vacuum pump
• Thumb or nger acvated vacuum
release valve
• Vacuum indicator*
• All in an ergonomic handle
Pump
Direcon
Vacuum
Release Buon
Vacuum Indicator
(mm Hg, Hg, kPa bar)
Rotate indicator
to view desired
scale
DEVICE DESCRIPTION
Foam Filter
(not removeable)
Shipping
Cap
ProCup®
The Kiwi ProCup is for use with low occiput anterior
and outlet presentaons. The so exible cup expands
and molds to the fetal head which increases cup
contact area on the fetal scalp.
*The vacuum gauge has demonstrated an accuracy of
+/- 10% of the range.

5

The Kiwi ProCup is suitable for occipitoanterior posions where the exion point
is near the introitus. Maneuverability of the ProCup cup is limited by the rigid cup
stem pressing against the labial ssues and
perineum.
The ProCup cup is maneuvered by pushing the
cup in the direcon of the exion point unl
further movement is inhibited as seen below.
The ProCup is not suitable for use in the
majority of midcavity occipitoposterior or
deexed occipitolateral posions because
the exion point in these cases is usually
located outside the range of movement of the
cup, thus making it dicult or impossible to
achieve a correct (exing median) applicaon.
The Kiwi ProCup is for outlet and low occiput
anterior presentaons.

6
CUP INSERTION
• Perform vaginal exam to ensure amnioc membranes are ruptured, cervix is
completely dilated and eaced and to determine fetal staon, posion, and
exion point locaon.
• Retract perineum with two ngers of non-pulling hand to form a space into
which cup is inserted gently in one movement.
• Slightly rotate to ensure cup edges unfold.
• Press cup against fetal head and maneuver unl its center lies over exion point.
• Check that there is no maternal ssue, or a fetal electrode trapped between cup
and scalp by holding cup in posion with one hand and running index nger of
other hand around rim of cup.
• Iniate cup seal by raising vacuum to approximately 100 mm Hg (yellow zone) on
PalmPump vacuum indicator.
• Re-examine to ensure no maternal ssue has been drawn under cup and reapply
cup if necessary.



7
VAGINAL DELIVERY

The operator should sit on a stool unl the head has descended to the level of the
pelvic outlet so that tracon will be exerted in a downward direcon and assist
descent of presenng part by maintaining the exion point on or just behind axis of
pelvis.
The operator should change the direcon of tracon progressively upwards for low
deliveries or as the fetal head descends to the outlet. As this is done, the standing
posion becomes more appropriate.

1. Once contracon begins, rapidly raise vacuum to 450-600 mm Hg (green zone)
according to hospital protocol. DO NOT EXCEED 620 mm Hg (RED ZONE)
2. Press against dome of cup with thumb of non-pulling hand to help prevent cup
detachment from scalp and detect early signs of detachment. Reduce tracon
force accordingly.
3. Rest index nger of same hand on scalp in front of cup and monitor descent of
head.
4. Apply tracon in line with pelvic axis and draw fetal head down over perineum
with each contracon.
5. For maximum eciency and best results, direct pull perpendicular to cup.
6. Pendulum or rocking movements from side to side may also increase
predisposion to cup detachment.
7. Disconnue tracon between contracons or if an audible hiss is heard, signaling
loss of vacuum.

8
Inches cm
Kg/cm² kPa mm Hg Hg H O lb/in² bar
2
0.13 13 100 3.9 134 1.9 0.13
0.27 27 200 7.9 268 3.9 0.26
0.41 40 300 11.8 402 5.8 0.39
0.54 53 400 15.7 536 7.7 0.53
0.68 67 500 19.7 670 9.7 0.66
0.82 80 600 23.6 804 11.6 0.79
0.95 93 700 27.0 938 13.5 0.92
1.03 101 760 29.9 1018 14.7 1.00
Axis of pelvis
From: Vacca A. Handbook of Vacuum Extraction.
Table 2: Equivalent negative gauge pressures
Progress
• The rst pull should cause exion of the head and some descent. By the end of the
second pull the head should be on the pelvic oor and with the third pull, delivery of the
head should be complete or imminent.
• With strong contracons and eecve maternal expulsive eort, delivery should be
achieved.

DO NOT REAPPLY IF CUP HAS  TWO TIMES
Delivery
• Release vacuum with release buon aer delivery of head.
• Ease cup o the scalp.
• Complete birth in normal manner.

• Examine baby’s head immediately aer birth for scalp injury and note cup applicaon
site.
• Neonatal care providers should be made aware of the mode of delivery in order to

9
observe for potenal complicaons associated with operave vaginal delivery.
• Inspect scalp regularly if diculty was experienced to exclude bleeding into the
subgaleal space.
• Reassure parents that chignon should disappear in a maer of hours and that
marks from cup should leave no traces aer a few days.
• Reexamine baby within 24 hours to check the applicaon site of vacuum cup.

Symbol Symbol Descripon
Indicates Device Manufacturer
Includes name and address of the manufacturer
Manufacturer Build Date
Use By Date YYYY-MM-DD is generic placeholder for specied Use By Date
Vacuum
Release
Buon
Disposal
• Discard device using appropriate procedure.

10
Symbol Symbol Descripon
Lot Code
Authorized EC Representave
Catalog Number
Do Not Reuse
STERILE R Sterilized by Irradiation. Sterility Guaranteed Unless
Package Opened or Damaged. Do Not Resterilize.
Consult Instrucons For Use
Do not use if the product sterile barrier system or its packaging is compromised
Cauon: Federal (USA) law restricts this device to sale by or on the order of a
physician
Warning or cauon
Do not

forMOM.forBABY.forLIFE.
Copyright 2018, Clinical Innovaons, LLC.
All rights reserved. ART-0089 REV 1
Clinical Innovaons
747 West 4170 South
Murray, Utah USA 84123
P. 801-268-8200
Toll Free: 888-268-6222 Clinical Innovaons Europe, Ltd.
6-9 The Square | Stockley Park,
Heathrow UB11 1FW | United Kingdom
Tel [phone]
clinicalinnovaons.com