Purpose; Warnings And Precautions; Warnings - Hologic Aquilex Instrucciones De Uso

3

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 Warnings

WARNING!
Distension media
When performing monopolar hysteroscopic electrosurgery, the distension medium
must be electrically non-conductive. Examples include glycine, sorbitol and man-
nitol. Isotonic saline irrigation fluids may only be used when performing bipolar
electrosurgical resective procedures.
WARNING!
Pressure
The pressure should be kept as low as possible to allow for a sufficient intrauterine
distention and to reduce the forces that could allow fluid, ambient air, and/or gas
to enter the circulatory system.
WARNING!
Intrauterine distention
Intrauterine distention is usually possible with pressure values between 35 to
70 mmHg. A pressure above 75 mmHg is required only in rare cases or if the pa-
tient has an excessively high blood pressure.
WARNING!
Fluid overload
There is a risk of irrigation fluid reaching the circulatory system of the patient's soft
tissue by passing through the uterus. This can be affected by distention pressure,
flow rate, perforation of the uterine cavity and duration of the hysteroscopic sur-
gery. It is critical to closely monitor the input and outflow of the distending liquid
at all times.
Intended Use
Contraindications
Purpose
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