Cooper Surgical MityOne MitySoft 10068 Instrucciones De Uso

CAUTION: U.S. Federal law restricts this device to sale by or on the order
DEVICE DESCRIPTION
® ®
The MityOne MitySoft Bell Cup 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

Less than 34 weeks gestation

Unengaged vertex

Incompletely dilated cervix

Previous scalp sampling

Suspected macrosomia, or risk of shoulder dystocia

Failed vacuum or forceps attempt

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.
10068 • MityOne
Vacuum-Assist Delivery System • Instructions for Use (English)
® MitySoft ® Bell Cup
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.
2. 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.
3. 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.
4. Wipe the scalp as clean as possible.
5. To insert the MityOne MitySoft Bell
Cup, grasp the cup with the fingers
and fold edges inward to facilitate
insertion (see Figure 1).
6. 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) to initiate vacuum. Recheck the rim of the cup for interposed
extraneous tissue.
1
Figure 1 – MitySoft Bell Cup
Posterior
Fontanelle
3 cm
Flexion Point
6 cm Sagittal Suture
Anterior Fontanelle
Figure 2 - Infant head