CooperSurgical Mityvac 10022 Gebrauchsanweisung Seite 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 Instructions for Use are specific and different for each configuration
of Mityvac vacuum extraction cup. Follow the Instructions 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:
Calibration
0 in. – 7.5 in. Hg
Points (0–19 cm Hg)
Tolerances ± 0.9 in. Hg
(± 2.3 cm Hg)
VACUUM CONVERSION CHART
Kg/cm kPa mm Hg cm Hg
2
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.
The Reusable Silicone Vacuum Extraction Cup must be separated
from the vacuum tubing and the MityVac pump. Both the cup and the
pump must be cleaned separately.
2. Remove the pump gauge by turning the
gauge counterclockwise while supporting
the pump junction
3. Prepare a solution with protein solubilizing soap and lukewarm tap
water following the detergent manufacturer's recommendation.
Note: Prolystica Enzymatic 2X detergent should be used at the
concentration of 2 mL / 1L of warm utility (tap) water at 25-30 °C
per manufacturer's recommendation.
4. Submerge and soak the MityVac Pump.
5. Ensure the device remains completely submerged in the
detergent solution. *
*Do not submerge the gauge
6. Actuate pump by squeezing handle at least five (5) times to draw
detergent solution through pump.
7. Soak for a minimum of 15 minutes.
8. Using a soft brush or sponge, help loosen and remove debris.
9. Use a channel brush to scrub the lumens of the MityVac pump (pump
vacuum nozzle and exhaust port).
Reusable Obstetrical Vacuum Pump • Instructions for Use • English (continued)
®
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)
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
10. After soaking and cleaning, rinse the device with cool utility (tap)
water at 18-22 °C for a minimum of 30 seconds.
11. Actuate pump by squeezing handle at least five (5) times to draw
rinse water solution through the vacuum nozzle into the pump.
DRYING
12. Towel dry or blow dry with air jet.
13. If water remains on the device, wipe with 70% isopropyl alcohol.
14. Lubricate pump body with medical grade silicone oil.
15. Assemble the pump gauge by turning the gauge clockwise while
supporting the pump junction.
16. Once the device is clean and dry it should be stored in a clean,
dry and free from particulate environment.
STERILIZATION INSTRUCTIONS
The Mityvac Reusable Obstetrical Vacuum Pump is supplied
Non-Sterile and may be sterilized before use within the sterile field.
Moist Heat Sterilization Process:
1.
Remove the pump handle by
using a screw driver while
supporting the pump junction
bar
2
1.9 0.13
3.9 0.26
5.8 0.39
6.9 0.46
7.4 0.50
2. Sterilize the pump using one of the two Moist Heat Sterilization
7.7 0.53
validation processes with the cycle parameters listed below.
8.9 0.60
9.7 0.66
STERILIZATION
11.6 0.79
PROCESS
Pre-Vacuum
Gravity
SUGGESTED PUMP TROUBLESHOOTING GUIDELINES
The following troubleshooting guidelines include possible diagnosis.
If after attempting to repair the pump it still is not fully functional, call
your CooperSurgical representative.
NOTE: Refer to the exploded view of the pump as needed. Remove
all accessories that may be attached to the Mityvac pump.
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 instructions. 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.
2 2
EXPOSURE EXPOSURE
TEMPERATURE TIME
275°F/135°C 3 minutes
250°F/121°C 30 minutes
DRY
TIME
30 minutes
30 minutes