Hologic AQL-100, Instructions For Use And Operator'S Manual

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Purpose of the System
5
EN
3 Purpose of the System
Indication for use Aquilex™ Fluid Control System is intended to provide liquid distension of the
uterus during diagnostic and operative hysteroscopy, and to monitor the volume
differential between the irrigation fluid flowing into and out of the uterus.
Contraindications 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!
When using the cart/scale, follow the exact operating instructions in this manu-
al.