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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 of the 10022
Handheld Vacuum Pump) and begin applying traction.
traction in harmony with contractions and along the pelvic axis. For an
electric vacuum source, refer to the Vacuum Conversion Chart.
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 of the 10022 Handheld Vacuum
Pump) while awaiting the next contraction or maintain vacuum at
current level. For the Mityvac® Handheld Vacuum Pump, the vacuum
release lever can be slowly pulled back with the index finger to lower
or release vacuum level. For an electric vacuum source, refer to the
Vacuum Conversion Chart.
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 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 THE 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 cup and tubing in accordance with all applicable
Federal, State and local Medical/Hazardous waste practices.
16. Document the use of the Mityvac 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. Connect cup to
pump using sterile suction tubing.
2. For Electric Vacuum Source: Connect sterile cup, tubing and
connector (order P/N 910000-310064) to the electric vacuum pump by
placing the tapered end of the connector securely into the hole of the
collection jar lid. Preset the desired vacuum levels at the vacuum
source. Refer to the Vacuum Conversion Chart as necessary.
CAUTION: DO NOT USE DEVICE IF GAUGE NEEDLE DOES NOT
INDICATE ZERO IN THE ABSENCE OF A VACUUM.
3. Check the integrity of the Mityvac 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.)
4. Enter the uterus routinely and assess fetal head position.
5. 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 THE CUP TO ANY PORTION OF THE
INFANT'S FACE.
6. Raise the vacuum to 15-22.8 in. Hg (38-58 cm Hg) (green shaded
area on gauge face of the 10022 Handheld Vacuum Pump) and
begin applying traction to gently bring the head upward through the
1, 2
incision.
For an electric vacuum source, refer to the Vacuum
Conversion Chart.
®
10020 • MItySoft
Bell Cup • Instructions for Use • English (continued)
1, 2
Always apply
7. Once the head is delivered, release vacuum 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.
8. Carefully examine infant's head and observe vital signs at regular
intervals to ensure infant's well-being.
9. Dispose of the cup and tubing in accordance with all applicable
Federal, State and local Medical/Hazardous waste practices.
10. Document the use of the Mityvac Delivery System and notify nursery
staff per hospital protocol.
Bofill, James A., MD, et al., "The Mississippi Operative Vaginal Delivery Trial: Lessons
1
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.
VACUUM CONVERSION CHART
Kg/cm
2
kPa
mm Hg
0.13
13
100
0.27
27
200
0.41
40
300
0.47
47
356
0.51
51
382
0.54
53
400
0.61
61
459
0.68
67
500
0.82
80
600
EXPLANATION OF SYMBOLS
Reorder
REF
number
LOT
Batch
code
Use-by date
Not made
LATEX
with natural
rubber latex
2
Do not re-use
Do not use if
package is
damaged
R
Only
Caution: U.S. Federal law restricts this device to sale by
x
or on the order of a physician.
© 2018 CooperSurgical, Inc.
2
cm Hg
in. Hg
cm H
O
lb/in.
2
10
3.9
134
20
7.9
268
30
11.8
402
36
14
478
38
15
512
40
15.7
538
46
18
615
50
19.7
670
60
23.6
804
Consult
instructions
for use
!
Caution
Sterilized using
STERILE EO
ethylene oxide
Authorized
Representative
EC REP
in the European
Community
Keep dry
Manufacturer
2
bar
1.9
0.13
3.9
0.26
5.8
0.39
6.9
0.46
7.4
0.50
7.7
0.53
8.9
0.60
9.7
0.66
11.6
0.79
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