Mityvac Mystic II MitySoft Guia Del Usuario

10058 • Mystic
Vacuum-Assist Delivery System
Directions for Use (English)
DEVICE DESCRIPTION
® ®
The Mityvac Mystic II MitySoft
Cup is designed to assist a practitioner
in the delivery of an infant during
childbirth. The Mityvac Mystic II is an integrated pump and cup system,
packaged, and sterilized for immediate use.
WARNINGS

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.
CAUTION: U.S. Federal law restricts this device to sale by or on the order
of a physician.
INDICATIONS FOR VACUUM-ASSISTED VAGINAL DELIVERY
No indication is absolute.
Fetal:

Non-reassuring 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.
®
II MitySoft
®
Bell
®
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 Mityvac Mystic II 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 Mystic II 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.
Figure 1 – MitySoft Bell Cup
Posterior
Fontanelle
3 cm
Flexion Point
6 cm
Sagittal Suture
Anterior Fontanelle
Figure 2 - Infant head
10058-DFU • Rev. A • 8/13