Cooper Surgical Mityvac 10022 Instrucciones De Uso página 2

10022 • Mityvac
OPERATING INSTRUCTIONS
The physician must assess the delivery situation to evaluate the
appropriateness of using vacuum extraction to aid in delivery based on
training and experience with vacuum extraction and the unique
circumstances of each birth. Always use with caution and professional
judgment. Willingness to abandon this method after three attempts must
be practiced.
These Directions for Use are specific and different for each configuration
®
of Mityvac vacuum extraction cup. Follow the Directions for Use included
in each pre-packaged, sterile, disposable vacuum extraction delivery kit.
Read these instructions thoroughly before operating the unit. We
recommend that the pump and gauge calibration be checked prior to each
use. To check calibration compare the pump gauge against a master
gauge traceable to NIST Standards at three calibration points:
Pump gauge tolerances:
0 in. – 7.5 in. Hg
Calibration
Points (0–19 cm Hg)
± 0.9 in. Hg
Tolerances
(± 2.3 cm Hg)
VACUUM CONVERSION CHART
2
Kg/cm 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
CLEANING
1. After completing the delivery procedure, the pump should be wiped
off using a disinfectant (i.e. HI-TOR or other anti-microbial solution)
and a damp cloth. When cleaning the pump, do not immerse
the gauge.
2. AVOID DRAWING FLUIDS INTO THE PUMP DURING THE
PROCEDURE. However, if blood or mucus is inadvertently pulled
into the pump during the procedure, remove the exhaust port
cover, submerse the vacuum nozzle in warm water and flush the
pump thoroughly with clean water immediately. Do not allow the
body fluids to dry inside the pump. Aim the pump so that liquid
shooting from the exhaust port is safely directed back into the
water receptacle. Replace the cover and continually draw air into
the pump until water is no longer present.
CLEAN AS SOON AS POSSIBLE AFTER USE. This includes
separation of the pump handle assembly, piston rod assembly, junction
assembly, and gauge. See exploded view of pump on the following
page. Soak the piston rod assembly and junction assembly (to include
all internal surfaces) in a solution of protein solubilizing soap and
lukewarm tap water following manufacturer's instructions. Do not use
hot water as it will alter organic materials making them difficult to
remove. Scrub with a soft brush or sponge to loosen and remove debris
and lubricant. Inspect parts, including areas near gauge, exhaust valve
and trigger ports to verify that no visible signs of debris or lubricant are
present. Rinse all components thoroughly in tap water. Towel dry or
blow dry with air jet.
NOTE: Water left in the pump may lead to mechanism or gauge failure.
Perform a final wipe down of all parts using 70% isopropyl alcohol.
Lightly lubricate pump body (inside barrel) with medical grade silicone
oil (non-petroleum based). Reassemble pump.
STERILIZE THE PUMP BEFORE REUSE.
®
Reusable Obstetrical Vacuum Pump • Directions for Use • English
7.5 in. – 22.5 in. Hg 22.5 in. – 30 in. Hg
(19–57 cm Hg) (57–76 cm Hg)
± 0.6 in. Hg ± 0.9 in. Hg
(± 1.5 cm Hg) (± 2.3 cm Hg)
cm Hg In. Hg cm H O lb/in.
2
10 3.9 134 1.9
20 7.9 268 3.9
30 11.8 402 5.8
36 14 478 6.9
38 15 512 7.4
40 15.7 538 7.7
46 18 615 8.9
50 19.7 670 9.7
60 23.6 804 11.6
STERILIZATION INSTRUCTIONS
The Mityvac Reusable Obstetrical Vacuum Pump is supplied Non-
Sterile and may be sterilized before use within the sterile field.
STEAM STERILIZATION/AUTOCLAVE: The Mityvac reusable
obstetrical vacuum pump may be autoclaved. Follow the directions of
your autoclave equipment manufacturer regarding length of time and
temperature. Sterilize pump at 270 °F (132 °C) at 30 psi (2.1 Kg/cm
for 20 minutes.
ETHYLENE OXIDE STERILIZATION RECOMMENDATION
Temperature........... 40 °F (4.4 °C) (maximum)
Precondition ........... 60 minutes -0/+10 minutes
Prevacuum ............. 24 in. Hg ± 2 in. Hg (61 cm Hg ± 5 cm Hg)
Pressure/Gas ......... 6-8 psig (550-660 mg/L)
Exposure ................ 4 hours (minimum)
Post Vacuum .......... 4 in. Hg 2x ± 2 in. Hg (61 cm Hg 2x ± 5 cm Hg)
Aeration .................. 12 hours -0/+1 hour at 120 °F (49 °C)
The particular EO cycle must be validated per the equipment
manufacturer's requirements.
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bar
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SUGGESTED PUMP TROUBLESHOOTING GUIDELINES
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The following troubleshooting guidelines include possible diagnosis. If
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after attempting to repair the pump it still is not fully functional, call
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your CooperSurgical representative.
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NOTE: Refer to the exploded view of the pump as needed. Remove
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all accessories that may be attached to the Mityvac pump.
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1. Cannot pull enough vacuum.
Diagnosis: Exhaust valve is not functioning properly.
Action: Clean valve seat and replace valve.
Diagnosis: Contamination.
Action: Inspect pump and components for particulates or foreign
matter. Clean as directed in these directions.
Replace pump or parts as necessary.
Diagnosis: Defective gauge.
Action: Remove and check the gauge; pump could be functioning,
but the gauge is not registering properly.
Replace if defective; see gauge replacement guidelines on following
page.
Diagnosis: Not enough lubrication.
Action: Lubricate by applying a thin coating of medical grade silicone
inside of pump body.
Diagnosis: Bent/fatigued body spring.
Action: Replace spring.
Diagnosis: Loose screws on exhaust fitting.
Action: Carefully tighten screws. DO NOT OVER TIGHTEN. Over
tightening may result in stripping of the plastic threads.
Diagnosis: Distorted piston.
Action: Replace piston rod assembly.
We recommend that the pump and gauge calibration be checked
before each use.
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10022-DFU • Rev. A • 9/13
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