Important Operator/User Notes; Trademark Notice; Manufacturer; Indications For Use - Hologic Fluentpro Bedienungsanleitung

1 Introduction to System, Warnings and Precautions

Important Operator/User Notes

1.1
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).

Trademark Notice

1.1.1
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.

Manufacturer

1.1.2
HOLOGIC, INC.
250 Campus Drive,
Marlborough, MA, 01752 USA
1.800.442.9892 (US Toll Free)

Indications For Use

1.1.3
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.

Intended Users

1.1.4
The gynecologist should be trained in diagnostic and therapeutic hysteroscopy, resection, and removal
of gynecological tissue.

Intended Use Environment

1.1.5
The Fluent Pro Fluid Management System is designed to be used in operating rooms, ambulatory
surgical centers, and physician's office environments.

Patient Target Group

1.1.6
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.

Contraindications

1.1.7
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.

Important User Notes

1.1.8
1.1.8.1
1.1.8.2
English
Fluent Pro Fluid Management System
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.
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:
Introduction 1