Essential Performance; Warnings And Precautions - Hologic FLUENT Anwenderhandbuch

Essential Performance

Essential Performance of the Fluent Fluid Management System is to provide fluid irrigation and monitor fluid use to prevent unacceptable levels of
intravasation.
Warnings, Cautions, and Notes Defined
The words WARNING, Caution, and
WARNING!
Warnings indicate risks to the safety of the patient or user. Failure to follow warnings may result in injury to the patient or user.
Caution!
Cautions indicate risks to the equipment. Failure to follow cautions may result in damage to the system or the potential loss of patient data or
system data.
Note:
Notes provide special information to clarify instructions or present additional information.

Warnings and Precautions

The operating instructions in this guide make the system easier to use, while the recommended maintenance procedures help to ensure optimal
performance over years of reliable use. As with any surgical instrument, there are important health and safety considerations. These are listed
below and highlighted within the text. In order to meet the IEC 60601 safety standard, this console is equipped with an potential equalization
conductor which can be used to bring other equipment into the same case potential as the console.
Note:
The following warnings and cautions apply only to the Fluent Fluid Management System. For details, warnings, and cautions on using the
hysteroscope and tissue removal device with the Fluent Fluid Management System, refer to the specific documentation for the device.
WARNING!
• Check all factory settings.
• Before using the Fluent Fluid Management System for the first time, please review all available product information.
• Before using the Fluent Fluid Management System, you should be experienced in hysteroscopic surgery with powered instruments. Healthy
uterine tissue can be injured by improper use of the tissue removal device. Use every available means to avoid such injury.
• Use only the Fluent Fluid Management System to connect to the MyoSure
result in failure of the device to operate or lead to patient or physician injury.
• The use of accessory equipment in the patient vicinity not complying with the equivalent medical safety requirements of this equipment
may lead to a reduced level of safety of the resulting system. The use of accessory equipment outside the patient vicinity not complying with
medical or otherwise appropriate safety requirements may lead to a reduced level of safety of the resulting system.
• The use of an accessory, transducer, or cable, other than those specified by Hologic may result in increased emissions or decreased immunity
of the Fluent Fluid Management System.
• 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.
• An air embolism can be the result of air contained in the tube set or connected instrument reaching the patient. Ensure there is always fluid in
the bag to prevent air from being pumped into the patient.
• Place the system in such a way as to allow for easy visualization of the display values, system functions, and access to the control elements.
• Pressing the ON/OFF switch does not disconnect the system from the wall power outlet. This requires pulling the power cord located in the
rear of the system.
• No modification of this equipment is allowed.
• To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
• To avoid risk to patient and operators, do not use this equipment in the presence of intentional magnetic sources, intentional ultrasound
sources, or intentional heat sources.
• Consult an expert on electromedicine safety before using this equipment near an RF generator to ensure proper setup and use. If you detect
or suspect any interference between the Fluent system and any other medical system, discontinue use of the Fluent system and contact
customer support.
English
Fluent Fluid Management System
Note carry special meanings.
Tissue Removal Device. Use of any other drive mechanism may
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Introduction
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