Introduction - Hologic FLUENT FLT-100 Manual Del Operador

This manual is written for medical personnel who will be responsible for operating the Fluent
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.) Federal law restricts this device to sale by or on the order of a physician pursuant to 21 CFR 801.109(b)(1).
Copyright/Trademark Information
Hologic and Fluent 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
HOLOGIC, INC.
250 Campus Drive,
Marlborough, MA 01752 USA
1.800.442.9892 (US Toll Free)
Indications For Use
The Fluent 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 fluid flowing into and out of the uterus while providing drive, control and suction for
hysteroscopic morcellators.
Intended Use
The Fluent Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to
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monitor the volume differential between the irrigation fluid flowing into and out of the uterus.
The Fluent Fluid Management System is designed to be used in operating room, ambulatory surgical center, and physician's office environments.
The gynecologist should be trained in diagnostic and therapeutic hysteroscopy, resection, and removal of gynecological tissue.
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 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.
Relative contraindications to endometrial ablation:
Hysteroscopic endometrial ablation, whether by laser or electrosurgery, should not be undertaken before adequate training, preceptorship, and
clinical experience. Additionally, tissue sampling is required prior to destruction of the endometrium. 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 intramural myomas with small submucous components.
Important User Notes
Read this manual carefully and become familiar with the operation and function of the Fluent 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
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Fluent Fluid Management System

Introduction

Introduction
Fluid Management System. It is extremely
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