Essential Performance; Warnings And Precautions; Definitions; List Of Warnings And Precautions - Hologic Fluentpro Bedienungsanleitung

1.1.8.3

Essential Performance

1.1.9
Essential Performance of the Fluent Pro Fluid Management System is to provide fluid irrigation to
distend the uterus to set pressure levels, and to provide fluid suction while monitoring fluid use to
prevent unacceptable levels of intravasation.

Warnings and Precautions

1.2

Definitions

1.2.1
1.2.1.1
1.2.1.2

List of Warnings and Precautions

1.2.2
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, the console is equipped
with a potential equalization conductor which can be used to bring other equipment into the same
electrical potential as the console.
Note: The following warnings and precautions apply only to the Fluent Pro Fluid Management System.
For details, warnings, and precautions on using the hysteroscope and tissue removal device with the
Fluent Pro fluid Management system, refer to the specific documentation for the device.
1.2.2.1
2
Fluent Pro Fluid Management System
• 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.
•
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.
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 system data.
List of Warnings
WARNING!
• An air embolism can be the result of air contained in the tubing or connected instrument
reaching the patient. Ensure there is always fluid in the Fluid Bag to prevent air from
being pumped into the patient.
To avoid the risk of electric shock, this equipment must only be connected to a supply
•
mains with protective earth.
• Do not prime inside the patient.
• The deficit is the total amount of fluid left in the patient or unaccounted for otherwise.
Estimating the fluid volume remaining in the patient is the physician's responsibility.
There is a risk of distension fluid reaching the circulatory system of the patient's soft
•
tissue by passing through the uterus. This risk can be affected by distention pressure,
flow rate, perforation of the uterine cavity and duration of hysteroscopic surgery.
• If a low viscosity liquid distention medium is used, intrauterine instillation exceeding two
(2) liters should be followed with great care due to the possibility of fluid overload. If a
high viscosity fluid (e. g. Hyskon) is used, the use of more than 500 mL should be
followed with great care. See labeling of specific fluid used (e.g. Hyskon) for additional
information.
In rare cases, idiosyncratic reactions, including intravascular coagulopathy and allergic
•
reaction including anaphylaxis may occur while performing hysteroscopy if a liquid
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