Kiwi OmniCup VAC-6000M User manual

INSTRUCTIONS FOR USE
VAC-6000M, VAC6000ME
Complete Vacuum Delivery System
with PalmPumpTM

2
Contents
One Kiwi OmniCup®with Palm Pump™.
Descripon
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.
Indicaons
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, 2)
in a mid-pelvic delivery when posion and staon are known, or 3) 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.
Contraindicaons
1) Arrest of descent where fetopelvic relaonships are considered to be inadequate,
KIWI SYSTEM

3
2) Unengaged presenng part, 3) All non-vertex presentaons (breech, face, brow,
transverse lie), 4) Non-ruptured membranes, 5) Incomplete cervical dilaon and
eacement, 6) Extreme prematurity, 7) Known fetal coagulopathies.
Precauons
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.”
Addional condions for close observaons:
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.
Never apply cup to any poron of infant’s face or exceed
recommended vacuum level, me limits, or cup “pop-o”
applicaons.

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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 OmniCup for all posions including
asynclic occiput posterior and transverse fetal malposions.
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
• Vacuum release buon
• Vacuum indicator*
• All in an ergonomic handle
OmniCup®
The Kiwi OmniCup (a universal cup for
all posions) has a low prole for
easy inseron.
This assists with proper placement
in fetal malposions such
as occiput posterior.
*The vacuum gauge has demonstrated an accuracy of +/- 10% of the range.
Pump
Direcon
Vacuum
Release Buon
Vacuum Indicator
(mm Hg, Hg, kPa bar)
Rotate indicator
to view desired
scale
Flexion Point
Distance
Markings
Foam
Filter
(not removeable)
DEVICE DESCRIPTION

5
The OmniCup is not restricted by the so
ssues of the vulva and perineum in its
movements because the sucon tube is
in the same plane as the body of the cup.
This feature allows the cup to be
easily inserted through the introitus,
maneuvered under the caput and can
be directed towards and over the exion
point.
OmniCup (occipitoposterior/transverse posions)
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, exing median applicaons
may be achieved consistently in nearly all malposions of the occiput.
Thus, the OmniCup should, by perming beer applicaons, decrease failure rate
when the occiput is transverse or posterior. The OmniCup can also be used in outlet
and low occiput anterior posions.

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Labor Process Enhancement
• Correct technique should
enhance the normal processes of
labor and should not depend on
tracon alone to eect delivery
of the baby.
• The key is to locate the exion
point and place the vacuum cup
properly over it.
• The exion point is situated on
the sagial suture 3 cm in front
of the posterior fontanelle.
Diameters of Fetal Head
• When a vacuum cup is aached
to the head and tracon is
applied, the cup becomes the
leading part.
• The center of the cup should
correspond to the exion point
so that tracon in the line of the
pelvic axis will promote exion
and synclism.
• This will result in the most
favorable presenng diameters
of the head leading through the
birth canal.
F
F
3 cm
3 cm
FF
F
F
The exion point is situated on the sagial suture 3
cm forward of the posterior fontanelle.
Flexing Median Applicaon
The center of the vacuum cup should be placed
over the exion point with the sagial suture
in the midline.
F
F
3 cm
3 cm
FF
F
F
FLEXION POINT

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Flexion Point Locaon
The exion point may be located during vaginal examinaon by idenfying
the posterior fontanelle and then moving the nger anteriorly a distance of
approximately 3 cm along the sagial suture. The p of the nger will mark the
exion point.
• Observaon of the distance from exion point to posterior fourchee is required.
Distance Measurement
• Place p of examining nger on
exion point.
• Calculate distance from exion point
to fourchee by measuring distance
from p to where nger makes
contact with fourchee.
• The distance from the p of the
middle nger to the proximal
interphalangeal joint is 5 - 6 cm, and
to the metacarpophalangeal joint is
10 - 11 cm.
• OmniCup tubing has markings to
assist the user in the locaon of
these distances as shown in the
gures. These markings also help to
idenfy how much progress is made
during each contracon.

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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 Inseron
3. Perform vaginal exam to ensure amnioc membranes are ruptured, cervix is
completely dilated and to determine fetal staon, posion, and exion point
locaon.
4. Note the distance from the exion point to the posterior fourchee (inseron
distance).
5. Retract perineum with two ngers of non-pulling hand to form a space into
which cup is inserted gently in one movement.
6. Press cup against fetal head and maneuver the cup posteriorly the inseron
distance noted above unl its center lies over exion point.
7. Check that cup is correctly placed by nong that there is a distance of at least
3 cm between anterior fontanelle and nearest part of cup (applicaon distance)
and that sagial suture passes under middle of cup.
8. Check that there is no maternal ssue or a fetal electrode trapped between cup
and scalp in anterior posons by holding cup in posion with one hand and
running index nger of other hand around rim of cup. (With occipitotransverse
and posterior posions, it is usually impossible to reach behind a correctly placed
cup without displacing the cup.)
9. Iniate cup seal by raising vacuum to approximately 100 mm Hg (yellow zone) on
PalmPump vacuum indicator.
10. Re-examine to ensure no maternal ssue has been drawn under cup and reapply
cup if necessary.
DO NOT PLACE CUP ON ANY
PORTION OF FETAL FACE OR EAR.
ONLY PLACE CUP OVER FLEXION
POINT.

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Posioning of the Operator
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.
For rotaonal deliveries from the midpelvis, the operator may nd it easier to direct
tracon towards the oor by geng down on one knee for the inial pull.
Tracon
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. However, with midpelvic rotaonal procedures, oblique tracon is oen
necessary and cauon must be exercised because oblique traconal forces may
increase predisposion to cup detachments.
7. Pendulum or rocking movements from side to side may also increase
predisposion to cup detachment.
8. Maintain constant tracon for duraon of contracon.

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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
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
From: Vacca A. Handbook of Vacuum Delivery: In Obstetric Pracce, 3rd Edion
9. Disconnue tracon between contracons or if an audible hiss is heard,
signaling loss of vacuum.
10. Reduce vacuum (yellow zone) between contracons (oponal)
per hospital protocol.
11. Repeat steps unl delivery of head is complete or unl maximum
recommended me or re-applicaon limits are met.

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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 as
follows:
• 1 or 2 pulls for outlet vacuum deliveries,
• 2 or 3 pulls for low vacuum deliveries,
• 3 or 4 pulls for mid pelvic procedures.
Note: If tracon is misdirected
or too forceful, vacuum may be
broken. Before replacing cup,
examine fetal scalp for trauma and
re-assess posion.
DO NOT TWIST, TORQUE,
OR USE EXCESSIVE FORCE.
DO NOT REAPPLY IF CUP HAS
BEEN DISENGAGED TWO TIMES

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Delivery
1. Release vacuum with release
buon aer delivery of head.
2. Ease cup o the scalp.
3. Complete birth in normal
manner.
Aer Delivery
1. Examine baby’s head
immediately aer birth for scalp
injury and note cup applicaon site.
2. Neonatal care providers should be made aware of the mode of delivery in order
to observe for potenal complicaons associated with operave vaginal delivery.
3. Inspect scalp regularly if diculty was experienced to exclude bleeding into the
subgaleal space.
4. 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.
5. Reexamine baby within 24 hours to check the applicaon site of vacuum cup.
Disposal
• Discard device using established procedure.
Vacuum
Release
Buon

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INSTRUCTION FOR CESAREAN DELIVERY
OmniCup (Cesarean Secon)
The Kiwi OmniCup is suitable for cesarean secon deliveries. It’s low prole cup is
ideal for easy inseron and maneuverability in the conned abdominal space.
Preparaon
1. Prepare the mother for C-Secon according to hospital protocol.
2. Use established protocol for abdominal and uterine incisions.
3. Assess fetal head posion, locang the exion point 3 cm in front of the posterior
fontanelle along the sagial suture.
Cup Inseron
1. Insert cup into the incision.
2. If the fetal head is high, place cup over occiput on exion point.
3. If the fetal head is low, gently ex the head upward into the uterine incision with
ngers and place the cup over the exion point.
DO NOT PLACE CUP ON ANY PORTION OF FETAL FACE OR EAR
4. Check the edges of the cup to ensure that no maternal, placental, or other
ssues have been drawn underneath the cup.
5. Raise vacuum level to 100 mmHg (yellow zone) and recheck the cup edges.
Delivery
1. Raise vacuum to 450-600 mm Hg (green zone).
2. Gently draw fetal head upward through incision.
3. When fetal head is delivered, release vacuum with release valve buon and
remove cup before connuing delivery of shoulders and body.
Note: If tracon is misdirected or too forceful, vacuum may be broken.
Before replacing cup, examine fetal scalp for trauma and re-assess posion.
DO NOT TWIST, TORQUE, OR USE EXCESSIVE FORCE.
DO NOT REAPPLY IF CUP HAS BEEN DISENGAGED TWO TIMES

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Aer Delivery
• Examine baby’s head immediately aer birth for scalp injury and note cup
applicaon site.
• 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.
Vacuum
Release
Buon
Disposal
• Discard device using established procedure.
Symbols Glossary
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

15
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-0080 Rev 02
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Murray, Utah USA 84123
P. 801-268-8200
Toll Free: 888-268-6222 Clinical Innovaons Europe, Ltd.
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