Explanation Of Symbols - CooperSurgical MityOne M-Style Mushroom Instrucciones De Uso

10067 • MityOne
6. Gently move a finger around the rim of the cup to remove
intrusion of extraneous tissues and to ensure proper cup
placement.
7. With the cup placed over the flexion point, raise the vacuum level
to approximately 3.9 in. (10 cm Hg) (yellow shaded area on
gauge face) to initiate vacuum. Recheck the rim of the cup for
interposed extraneous tissue.
8. With the onset of contraction, rapidly raise the vacuum to
15-22.8 in. Hg (38-58 cm Hg) (green shaded area on gauge face)
and begin applying traction along pelvic axis.
CAUTION: DO NOT EXCEED RECOMMENDED VACUUM
LEVELS.
9. When the contraction is no longer
effective, discontinue traction. You
may reduce the vacuum to
approximately 3.9 in. Hg
(10 cm HG) (yellow shaded area
on gauge face) while awaiting the
next contraction or maintain
vacuum at current level. Reduce
vacuum by slowly pushing or
pulling on the vacuum release lever located directly beneath the
gauge (see Figure 3).
10. Recheck for interposed extraneous tissue prior to each tractive
effort.
11. If traction is misaligned or too forceful, the vacuum cup may
disengage (pop off). In case of pop off, check fetal scalp for
trauma before reapplying vacuum cup.
CAUTION: ABANDON VACUUM-ASSISTED DELIVERY IF THE
VACUUM CUP DISENGAGES (POPS OFF) THREE TIMES.
12. With each successive contraction, draw the head gently over the
perineum. Once the head is delivered, release vacuum (see
Figure 3) and remove the cup. Continue delivery in the usual
manner. In the unlikely event that vacuum does not release,
with caution, use scissors and cut the stem, being careful to
avoid the fetal scalp.
CAUTION: DO NOT OPERATE VACUUM PUMP AT TRACTIVE
LEVELS FOR MORE THAN 10 CUMULATIVE MINUTES
OF TRACTION OR TOTAL PROCEDURE TIME OF 15 TO
30 MINUTES.
13. Carefully examine infant's head and observe vital signs at regular
intervals to ensure infant's well-being.
14. Dispose of the MityOne Delivery System in accordance with all
applicable Federal, State and local Medical/Hazardous
waste practices.
15. Document the use of the MityOne Delivery System and notify
nursery staff per hospital protocol.
PREREQUISITES FOR VACUUM-ASSISTED CESAREAN
DELIVERY

Proper indication for operative delivery

Proper indication for use of the vacuum-assisted delivery device
VACUUM-ASSISTED CESAREAN 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. Enter the uterus routinely and assess fetal head position.
3. If the fetal head is high and accessible beneath the uterine
incision, wipe the scalp as clean as possible and place vacuum
cup over the flexion point. If the head is low and inaccessible,
® M-Style ® Mushroom ® Cup • Instructions for Use • English
Figure 3 – Vacuum release lever
2
place gloved fingers under the head and flex upward to bring the
scalp under the uterine incision. Wipe scalp as clean as possible
and apply the vacuum cup to the flexion point.
CAUTION: NEVER APPLY THE CUP TO ANY PORTION OF
THE INFANT'S FACE.
4. Raise the vacuum to 15 - 22.8 in. Hg (38 - 58 cm Hg) (green
shaded area on gauge face) and begin applying traction to gently
bring the head upward through the incision.
5. Once the head is delivered, release vacuum by slowly pushing or
pulling on the vacuum release lever (see Figure 3) and remove
the cup. Continue delivery in the usual manner. In the unlikely
event that vacuum does not release, with caution, use
scissors and cut the stem, being careful to avoid the fetal
scalp.
6. Carefully examine infant's head and observe vital signs at regular
intervals to ensure infant's well-being.
7. Dispose of the MityOne Delivery System in accordance with all
applicable Federal, State and local Medical/Hazardous waste
practices.
8. Document the use of the MityOne Delivery System and notify
nursery staff per hospital protocol.

EXPLANATION OF SYMBOLS

Reorder
number
Batch
code
Use-by date
Not made with natural
rubber latex
Do not
re-use
Manufacturer
Caution
© 2018 CooperSurgical, Inc.
1. Bofill, James A., MD, et al., "The Mississippi Operative Vaginal Delivery Trial: Lessons
Learned", Contemporary OB/GYN, October 1998.
2. Schifrin, Barry S., MD, et al., "Cutting Your Legal Risks with Vacuum Assisted
Delivery", OBG Management, June 1994.
(Continued)
1, 2
Keep dry
Consult
instructions for use.
Sterilized using
ethylene oxide
Authorized
Representative
in the European
Community
Caution: U.S. Federal
law restricts this device
to sale by or on the
order of a physician
Do not use if package is
damaged