CooperSurgical mityvac M-Style Mushroom 10015LP Instrucciones De Uso página 2

10007 LP and 10015LP • M-Style
7. Gently move a finger around the rim of the cup to remove intrusion of
extraneous tissues and to ensure proper cup placement.
8. With the cup placed over the flexion point, raise the vacuum level to
approximately 3.9 in. Hg (10 cm Hg) (yellow shaded area on gauge
face of the 10022 Handheld Vacuum Pump) to initiate vacuum.
Recheck the rim of the cup for interposed extraneous tissue. For an
electric vacuum source, refer to the Vacuum Conversion Chart.
CAUTION: BEFORE RAISING VACUUM TO TRACTIVE LEVELS,
MAKE CERTAIN THAT NO EXTRANEOUS TISSUE IS DRAWN INTO
THE VACUUM CUP.
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.
If using the 10015LP, release the vacuum by depressing the UVR tab.
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. 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.
Mushroom Cup • Instructions for Use • English (continued)
® ®
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
incision.
Conversion Chart.
Always apply
1, 2
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:
1.
Lessons Learned", Contemporary OB/GYN, October 1998.
Schifrin, Barry S., MD, et al., "Cutting Your Legal Risks with Vacuum Assisted
2.
Delivery", OBG Management, June 1994.
Kg/cm
2
0.13
0.27
0.41
0.47
0.51
0.54
0.61
0.68
0.82
EXPLANATION OF SYMBOLS
REF
LOT
LATEX
2
R Only
x
© 2018 CooperSurgical, Inc.
2
For an electric vacuum source, refer to the Vacuum
1, 2
VACUUM CONVERSION CHART
kPa mm Hg cm Hg in. Hg
13 100 10 3.9
27 200 20 7.9
40 300 30 11.8
47 356 36 14
51 382 38 15
53 400 40 15.7
61 459 46 18
67 500 50 19.7
80 600 60 23.6
Reorder
number
!
Batch code
Use-by date
STERILE EO
Not made with
EC REP
natural rubber
latex
Do not re-use
Do not use if
package is
damaged
Caution: U.S. Federal law restricts this device to sale by
or on the order of a physician.
cm H O lb/in. bar
2
2
134 1.9 0.13
268 3.9 0.26
402 5.8 0.39
478 6.9 0.46
512 7.4 0.50
538 7.7 0.53
615 8.9
0.60
670 9.7 0.66
804 11.6 0.79
Consult
instructions for use
Caution
Sterilized Using
Ethylene Oxide
Authorized
Representative
in the European
Community
Keep dry
Manufacturer