Mityvac Mystic II MitySoft Guia Del Usuario página 2

9. 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
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traction. Always apply traction in harmony with contractions and along
the pelvic axis.
CAUTION: DO NOT EXCEED RECOMMENDED
VACUUM LEVELS.
10. 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).
11. Recheck for interposed extraneous tissue prior to each tractive effort.
12. 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.
13. 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 TEN CUMULATIVE MINUTES OF
TRACTION OR TOTAL PROCEDURE TIME OF 15 TO 30 MINUTES.
14. Carefully examine infant's head and observe vital signs at regular
intervals to ensure infant's well being.
®
15. Dispose of the Mityvac Mystic
all applicable Federal, State and local Medical/Hazardous waste
practices.
16. Document the use of the Mityvac Mystic II 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. 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.
95 Corporate Drive • Trumbull, CT 06611 USA
Phone: (800) 243-2974 • Fax: (800) 262-0105
www.coopersurgical.com
10058-DFU • Rev. A • 8/13
®
10058 • Mystic II MitySoft
Figure 3 – Vacuum release lever
®
II delivery system in accordance with
®
Bell Cup • Directions for Use • English
3. Enter the uterus routinely and assess fetal head position.
4. 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, 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 CUP TO ANY PORTION OF THE
INFANT'S FACE.
5. 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.
6. Once the head is delivered, release vacuum by 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.
7. Carefully examine infant's head and observe vital signs at regular
intervals to ensure infant's well being.
8. Dispose of the Mityvac Mystic II delivery system in accordance with all
applicable Federal, State and local Medical/Hazardous waste practices.
9. Document the use of the Mityvac Mystic II delivery system and notify
nursery staff per hospital protocol.
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.
EXPLANATION OF SYMBOLS
Reorder
number
Batch
code
Use by date
Latex
free
Do not
reuse
Manufacturer
®
Mityvac , Mystic
CooperSurgical, Inc., its subsidiaries, and/or affiliates.
CooperSurgical is a registered trademark of CooperSurgical, Inc.
© 2013 CooperSurgical, Inc.
International
Phone: (203) 601-9818
Fax: (203) 601-4747
(Continued)
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Keep dry
ATTENTION:
See instructions for use
Product conforms to Medical
Device Directive 93/42/EEC
Sterilized Using Ethylene
Oxide
Authorized Representative
in the European Community.
® ®
II and MitySoft are registered trademarks of
EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
.
CooperSurgical, Inc
95 Corporate Drive
Trumbull CT 06611 USA
Made in the USA