Mityvac 10057 Gebrauchsanleitung

10057 • Mystic
Vacuum-Assist Delivery System
Directions for Use (English)
DEVICE DESCRIPTION
® ®
The Mityvac Mystic II M-Style
®
Mushroom 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 effort
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.
® ®
II M-Style Mushroom
®
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. 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.
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.
6. Gently move a finger around the rim of the cup to remove
intrusion of extraneous tissues and to ensure proper
cup placement.
Figure 1 - M-Style Mushroom Cup
Posterior
Fontanelle
3 cm
Flexion Point
6 cm Sagittal Suture
Anterior Fontanelle
Figure 2 - Infant head
10057-DFU• Rev. A • 8/13