CooperSurgical Mityvac Pearl Edge Bell Cup Instructions For Use Manual

CAUTION
U.S. Federal law restricts this device to sale
by or on the order of a physician.
DEVICE DESCRIPTION
The Mityvac Pearl Edge Bell Cup is designed
® ®
to assist a practitioner in the delivery of an infant during childbirth.
This Mityvac delivery kit is preassembled, packaged and sterilized for
immediate use with the Mityvac Handheld Vacuum Pump (10022). When
used with an approved electrical vacuum source with a vacuum release
mechanism, insert the connector (order P/N 910000-310064) into the
tubing and connect to electric unit's collection jar.
INDICATIONS FOR VACUUM-ASSISTED VAGINAL DELIVERY
No Indication is absolute.
Fetal:
• Nonreassuring fetal status
• Failure to deliver spontaneously following an appropriately managed
second stage of labor
Maternal:
• Need to avoid voluntary expulsive efforts
• Inadequate expulsive efforts
CONTRAINDICATIONS
Do not initiate vacuum if any of the following conditions exist:
• Non-vertex positions (breech or transverse lie/position) or face
or brow presentation
• Suspected cephalopelvic disproportion
• Previous scalp sampling
• Suspected macrosomia, or risk of shoulder dystocia
• Failed vacuum or forceps attempt
• Less than 34 weeks gestation
• Unengaged vertex
• Incompletely dilated cervix
• Need for active device rotation
• Suspected fetal bleeding abnormalities
ADVERSE EVENTS
Fetal Injuries:
Head trauma, bruises, contusions, lacerations, scalp edema, skull
fracture, cephalhematoma, subgaleal hematoma, subdural hemorrhage,
parenchymal hemorrhage, intracranial hemorrhage, retinal hemorrhage
Maternal Injuries:
Vaginal, cervical, uterine, bladder, rectal tissue tears
WARNINGS
• This product is for single use and not to be reused, reprocessed
or resterilized due to risk of contamination and/or cause patient/
fetal infection or cross-infection, including, but not limited to, the
transmission of infectious disease(s) from one patient/fetus to another.
• DO NOT exceed recommended vacuum levels.
• Never apply the vacuum cup to any portion of the infant's face.
• Vacuum-assisted delivery should only be performed or supervised by
a trained and experienced operator.
• "There should be a willingness to abandon attempts at vacuum
extraction if satisfactory progress is not made." (ACOG Technical
Bulletin #196, Aug. 1994)
• Abandon vacuum-assisted delivery if:
a. Vacuum cup becomes disengaged (pops off) three times.
b. Vertex has not advanced substantially with each traction attempt.
c. There is evidence of fetal scalp trauma.
d. Cumulative traction time exceeds 10 minutes or total vacuum
procedure time exceeds 15 to 30 minutes.
• If the extractor cup becomes disengaged, check for trauma to the fetal
scalp before reapplying.
10004 • Pearl Edge
Vacuum-Assist Delivery System • Instructions for Use
Bell Cup
®
(English)
PREREQUISITES FOR VACUUM-ASSISTED VAGINAL DELIVERY
• Term infant
• Ruptured membranes
• Empty bladder and nondistended rectum
• Engaged vertex position
• Complete cervical dilation and effacement
• Willingness to abandon procedure and plan for alternate delivery route
These instructions are intended as general guidelines. Practitioners
should refer to current institutional and recognized guidelines that
address vacuum-assisted delivery.
VACUUM-ASSISTED VAGINAL DELIVERY GUIDELINES
1. Remove the protective lid from the cup before use. Connect cup to
pump using sterile suction tubing.
2. For Electric Vacuum Source: Connect sterile cup, tubing and
connector (order P/N 910000-310064) to the electric vacuum pump
by placing the tapered end of the connector securely into the hole
of the collection jar lid. Preset the desired vacuum levels at the
vacuum source. Refer to the Vacuum Conversion Chart as
necessary.
CAUTION: DO NOT USE DEVICE IF GAUGE NEEDLE DOES NOT
INDICATE ZERO IN THE ABSENCE OF A VACUUM.
3. Check the integrity of the Mityvac Obstetrical Vacuum-Assist Delivery
System by pressing the cup to the palm of your gloved hand and
applying vacuum. The gauge needle should remain steady.
(NOTE: The gauge needle should rest in the "ZERO" box when
vacuum is not applied.)
4. Carefully examine fetal presentation and position prior to positioning
the cup over the flexion point.
CAUTION: DO NOT USE PRODUCT IF FLEXION POINT IS NOT
ACCESSIBLE.
5. Wipe the scalp as clean as possible.
6. To insert the Pearl Edge Bell Cup, grasp cup with the fingers and fold
edges inward to facilitate insertion (see Figure 1). Separate the labia
with the other hand. Press the cup portion downward and inward over
the fourchette to make contact with the fetal scalp.
Apply the center of the cup over the flexion point (see Figure 2).
The flexion point can be located by identifying the posterior fontanelle
and then moving the finger anteriorly along the sagittal suture
approximately 1.2 in. (3 cm). The sagittal suture should pass under
the middle of the cup.
CAUTION: NEVER APPLY THE CUP TO ANY PORTION OF THE
INFANT'S FACE.
7. Gently move a finger around the rim of the cup to remove intrusion
of extraneous tissues and to ensure proper cup placement.
8. With the cup placed over the flexion point, raise the vacuum level to
approximately 3.9 in. Hg (10 cm Hg) (yellow shaded area on gauge
face of the 10022 Handheld Vacuum Pump) to initiate vacuum.
Recheck the rim of the cup for interposed extraneous tissue. For an
electric vacuum source, refer to the Vacuum Conversion Chart.
CAUTION: BEFORE RAISING VACUUM TO TRACTIVE LEVELS,
MAKE CERTAIN THAT NO EXTRANEOUS TISSUE IS DRAWN
INTO THE VACUUM CUP.
Figure 1 - Bell Cup
Figure 1 - Bell Cup
1
®
-
Figure 2 - Infant head