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

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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 vol-
ume 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 hysterosco-
py is contraindicated. See the operators manual of your hysteroscope for abso-
lute 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 experi-
ence. Additionally, tissue sampling is required prior to destruction of the endo-
metrium. 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!
When performing monopolar hysteroscopic electrosurgery, the distension medi-
um must be electrically non-conductive. Examples include glycine, sorbitol and
mannitol. Isotonic saline irrigation fluids may only be used when performing bi-
polar electrosurgical resective procedures.
WARNING!
The pressure should be kept as low as possible to allow for a sufficient intrauter-
ine distension and to reduce the forces that could allow fluid, ambient air, and/
or gas to enter the circulatory system.
WARNING!
Intrauterine distention is usually possible with pressure values between 35 to
70 mmHg. A pressure above 75 to 80 mmHg is required only in rare cases or if the
patient 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 pres-
sure, flow rate, perforation of the uterine cavity and duration of the hystero-
scopic surgery. 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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