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Purpose
The Aquilex® Fluid Control System is intended to provide fluid distension of the
uterus during diagnostic and operative hysteroscopies and to monitor the volume
differential between the irrigation fluid flowing into and out of the uterus.
The system may not be used to introduce fluids into the uterus when hysteroscopy
is contraindicated. See the operator's manual of your hysteroscope for absolute
and relative contraindications.
Relative contraindications to endometrial ablation:
Hysteroscopic endometrial ablation, whether by laser or electrosurgery, should not
be undertaken before adequate training, preceptorship, and clinical experience.
Additionally, tissue sampling is required prior to destruction of the endometrium.
The following are clinical conditions that can significantly complicate hysteroscopic
endometrial ablation:
• Adenomatous endometrial hyperplasia
• Uterine leiomyoma
• Severe adenomyosis
• Pelvic pain (subtle PID)
• Uterine anomalies
• Surgical skill (see above)
• Severe anemia
• Inability to circumnavigate the myoma (re: myoma size) - predominantly intra-
mural myomas with small submucous components.
3.1
Warnings and Precautions
3.1.1 General Warnings
WARNING!
Failure of scale connection
If the message "Check Scale Connection" appears, the deficit must be calculated
manually. The pump keeps displaying the last known deficit value determined prior
to the failure of the scale connection.
WARNING!
Scale error
Make sure that screw connections at cable and pump are fixed hand-tight to avoid
loosening of connection during move or use.
WARNING!
Scale error
Ensure that nothing weighs down the scale during system start-up. Doing so may
result in an inaccurate deficit value.
WARNING!
Instrument replacement
Stop the device using the Pause/Resume and Prime button if replacing the instru-
ment during surgery.
Intended Use
Contraindications
Purpose
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