Fluent Pro Fluid Management System
English Introduction 1
1 Introduction to System, Warnings and Precautions
1.1 Important Operator/User Notes
This manual is written for medical personnel who will be responsible for operating the Fluent® Pro Fluid Management System. It is
extremely important that the operator read and thoroughly understand the contents of this manual, and follow the instructions
contained herein for reliable, safe, and efficient operation of the product.
Rx ONLY (U.S.) - Caution: Federal law restricts this device to sale by or on the order of a physician pursuant to 21 CFR 801.109(b)(1).
1.1.1
Trademark Notice
Hologic, Fluent, MyoSure, and associated logos are registered trademarks of Hologic, Inc. and its subsidiaries in the United
States and other countries. All other trademarks, registered trademarks, and product names are the property of their
respective owners.
1.1.2
Manufacturer
HOLOGIC, INC.
250 Campus Drive,
Marlborough, MA, 01752 USA
1.800.442.9892 (US Toll Free)
1.1.3
Indications For Use
The Fluent Pro Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and
operative hysteroscopy, and to monitor the volume differential between the irrigation liquid flowing into and out of the
uterus while providing drive, control, and suction for hysteroscopic morcellators.
1.1.4
Intended Users
The gynecologist should be trained in diagnostic and therapeutic hysteroscopy, resection, and removal of gynecological
tissue.
1.1.5
Intended Use Environment
The Fluent Pro Fluid Management System is designed to be used in operating rooms, ambulatory surgical centers, and
physician’s office environments.
1.1.6
Patient Target Group
The intended patient population for the Fluent Pro Fluid Management System is dependent on the Indications for Use and
Contraindications; it is not limited by age, weight, or other health conditions unrelated to hysteroscopic contraindications.
1.1.7
Contraindications
• 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.
• The Fluent Pro Fluid Management System should not be used to remove pathologies from pregnant patients or
patients exhibiting pelvic infection, cervical malignancies, or previously diagnosed endometrial cancer.
1.1.8
Important User Notes
1.1.8.1 No modification of this equipment is allowed unless by a Hologic trained professional. Service mode is
password protected and is intended for Hologic Trained professionals only.
1.1.8.2 Read this manual carefully and become familiar with the operation and function of the Fluent Pro Fluid
Management System and the accessories before use during surgical procedures. Non-observance of the
instructions listed in this manual can lead to:
• Life-threatening injuries to the patient.
• Severe injuries of the surgical team, nursing staff, or service personnel.
• Damage or malfunction of the system and/or accessories.
1.1.8.3 Intrauterine distension can usually be accomplished with pressures in the range of 35-75 mmHg. Unless the
systemic blood pressure is excessive, it is seldom necessary to use pressures greater than 75-80 mmHg.
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