Contraindications - CooperSurgical Kronner Manipujector 6003 Mode D'emploi

6003 • Kronner Manipujector
Instructions for Use • English (continued)

CONTRAINDICATIONS

The Kronner Manipujector (Uterine Manipulator-Injector) should not be used in patients
who are pregnant or in patients suspected of being pregnant or with active pelvic
infections.
WARNINGS
The Kronner Manipujector (Uterine Manipulator-Injector) should be inserted along
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the correct axis (which depends upon the position of the uterus) to reduce the
possibility of uterine trauma. Sound the uterus prior to using the Kronner
Manipujector (Uterine Manipulator-Injector) to determine both the direction and
depth of the uterus.
Always preset the sliding handle cervical stop at the uterine sounded depth, e.g.,
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if sounded depth is 7 cm, set cervical stop at 7 cm. The cervical stop should be
set using the cm markings on the catheter. Adjust further after retracting the
balloon to the internal os. See Step 9.
NEVER use the device with the intrauterine balloon deflated.
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DO NOT underinflate the intrauterine balloon. Underinflation will defeat the
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purpose of the balloon; that is to provide a gentle "air cushion" against the uterine
wall for safer manipulator control. Underinflation may also result in spontaneous
expulsion of the devices as intrauterine pressure builds during its use as a fluid or
gas injector. The use of 10 cc of air is recommended since approximately 2 cc will
be consumed in the pilot balloon and inflation tube.
NEVER use fluid to inflate the distal balloon. Use of fluid will not effectively inflate the
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distal balloon due to the small diameter of the inflation channel lumen and failure of
the device may occur. Moreover, the use of fluid could potentially cause the balloon
to burst since fluid is not compressible and the balloon will over-distend.
The Kronner Manipujector
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Diameter) of 5 mm. Its use in hysterosalpingography and Rubin's Test should be
reserved for the patient with a large uterus (multiparous, post-abortal, etc.) that
will accept this size comfortably without anesthesia. Otherwise it is recommended
that the Kronner Manipujector's (Uterine Manipulator-Injector) companion
instruments, HUI
Uterine Injector), be used (see separate package insert for HUI or HUI Mini-Flex
instructions).
As with any occlusive balloon device when used as an injector, the Kronner
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Manipujector (Uterine Manipulator-Injector) can create high intrauterine pressures
which could be accompanied by vascular extravasation. DO NOT inject fluid or
gas rapidly.
Contents supplied sterile. Do not use if sterile barrier is damaged.
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For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or
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resterilization may compromise the structural integrity of the device and/or lead to
device failure which, in turn, may result in patient injury, illness or death. Reuse,
reprocessing or resterilization may also create a risk of contamination of the
device and/or cause patient infection or cross-infection, including, but not limited
to, the transmission of infectious disease(s) from one patient to another.
Contamination of the device may lead to injury, illness or death of the patient.
Dispose of in accordance with all applicable Federal, State and local
Medical/Hazardous waste practices.
(Uterine Manipulator-Injector) has an OD (Outside
®
(Harris Uterine Injector) or HUI
®
Uterine Manipulator-Injector
®
Mini-Flex™ (Flexible Harris
®
2