Cooper Surgical MityOne M-Style Mushroom Cup 10067 Instructions For Use Manual

Vacuum-Assist Delivery System • Instructions for Use (English)
CAUTION: U.S. Federal law restricts this device to sale by or on the
order of a physician.
DEVICE DESCRIPTION
The MityOne ® M-Style ® Mushroom
is designed to assist a practitioner in the
delivery of an infant during childbirth. The
MityOne is an integrated pump and cup system, packaged, and
sterilized for immediate use.
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
10067 • MityOne
®
® Cup
M-Style Mushroom
®
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.
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. Check the integrity of the MityOne 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.)
CAUTION: DO NOT USE DEVICE IF GAUGE NEEDLE DOES
NOT INDICATE ZERO IN THE ABSENCE OF A VACUUM.
2. 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.
3. Wipe the scalp as clean as
possible.
4. To insert the M-Style Mushroom
Cup, fold the cup against the stem
at a 90° angle (see Figure 1).
5. With the stem in the bent
position, grasp the mushroom
shaped portion of the cup
with the fingers. The stem
should be parallel to palm
and wrist. Separate the labia
with the other hand.
Continuing with the stem in
the bent position, 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.
1
Cup
®
Figure 1 - M-Style Mushroom Cup
3 cm
6 cm
Figure 2 - Infant head
Hintere Fontanelle
Flexion Point
Sagittal Suture
Anterior
Fontanelle