Cooper Surgical MityOne MitySoft 10068 Instrucciones De Uso 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
1, 2
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, 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.
14. Carefully examine infant's head and observe vital signs at regular
intervals to ensure infant's well-being.
15. Dispose of the MityOne Delivery System in accordance with all
applicable Federal, State and local Medical/Hazardous waste
practices.
16. 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. 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.
®
10068 • MityOne MitySoft
Figure 3 – Vacuum release lever
®
Bell Cup • Instructions 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,
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 MityOne Delivery System in accordance with all applicable
Federal, State and local Medical/Hazardous waste practices.
9. Document the use of the MityOne Delivery System and notify nursery
staff per hospital protocol.
EXPLANATION OF SYMBOLS
© 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.
2
(Continued)
1, 2
Reorder
number
Batch
code
Use-by date
Not made with natural
rubber latex
Do not
re-use
Manufacturer
Caution
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