System Introduction
1.3
Introduction to the Fluent Pro Fluid Management System
1.3.1
The Fluent Pro Fluid Management System is designed to provide liquid distension of the uterus during
diagnostic and operative hysteroscopy while monitoring the volume differentials between fluid flowing
into and out of the uterus. Additionally, the Fluent Pro Fluid Management System supports the use of
the MyoSure
1.3.1.1
1.3.1.2
1.3.1.3
Shipping Contents
1.3.2
1.3.2.1
1.3.2.2
System Components
1.3.3
4
Fluent Pro Fluid Management System
®
tissue removal devices for tissue removal.
Technical Application Scope of the System
The Fluent Pro Fluid Management System allows Intrauterine Pressure to be adjusted
between 40 and 150 mmHg. The system inflow rates will automatically adjust to reach and
maintain the preset Intrauterine Pressure setting while the system outflow rates are adjusted
by the user through preset suction settings. The system has been designed to provide both
fluid and vacuum systems that maximize the performance of the MyoSure Tissue Removal
Device. The system provides varying levels of fluid suction.
Suggested Distension Media
The Fluent Pro Fluid Management System should only be used with sterile media. The
Fluent Pro Fluid Management System can be used with hypotonic, electrolyte-free media
(e.g., glycine 1.5% and sorbitol 3.0%) and isotonic, electrolyte containing media (e.g., saline
0.9% and Lactated Ringer's). See "List of Warnings," Section 1.2.2.1, for risks related to
viscosity and the use of a high viscosity media such as Hyskon.
Pressure Measuring and Regulating
The system operates with a non-contact pressure measurement of the distension medium.
The pressure control circuit continuously compares the desired preset Intrauterine Pressure
with the actual Intrauterine Pressure. The function of this algorithm is to maintain the preset
Intrauterine Pressure. Estimated Intrauterine Pressure can be retrieved from the top right
corner of the system display.
The shipping crate contains the Fluent Pro Fluid Management System console and a
shipping box with the Fluent Pro Fluid Management System components.
The following components are contained in the Fluent Pro Fluid Management System
shipping box:
•
Foot Pedal: Controls MyoSure tissue removal device (TRD) operation.
Power Cord: Establishes an electrical connection between the Fluent Pro Fluid
•
Management System and a wall outlet.
•
Fluent Pro Fluid Management System Operator's Manual: Manual that describes how
to use the Fluent Pro Fluid Management System.
Fluent Pro Fluid Management System User Reference Card: One sheet that highlights
•
how to use the Fluent Pro Fluid Management System.
A 500 g weight for completing the Scale Calibration Check.
•
For a list of components not included in the shipping crate, reference Table 9: Disposables
and Accessories.
Introduction
English