Fluent Fluid Management System
• Patient and operators are exposed to plastic (tube set, TRD), metal (console, TRD) and fluid (saline).
• Do not prime inside the patient.
Fluid overload:
There is a risk of irrigation fluid reaching the circulatory system of the patient's soft tissue by passing through the uterus. This can be affected by
distention pressure, flow rate, perforation of the uterine cavity and duration of the hysteroscopic surgery. It is critical to closely monitor the input
and outflow of the distending liquid at all times.
Fluid deficit:
The fluid left in the patient must be monitored. The deficit is the total amount of fluid left in the patient or unaccounted for otherwise. Take notice
of the measurement tolerance of the system. Estimating the fluid volume remaining in the patient is the physician's responsibility.
Fluid intake and output surveillance:
Strict fluid intake and output surveillance should be maintained. If a low viscosity liquid distention medium is used, intrauterine instillation
exceeding 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 for Hyskon for additional information.
Hyponatremia:
Some distension fluids may lead to fluid overload and, consequently, hyponatremia with its attending sequelae. This can be affected by the
distending pressure, flow rate, and duration of hysteroscopic procedure. It is critical to closely monitor the input volume and outflow volume of
the distending liquid at all times.
Pulmonary edema:
Hysteroscopic surgery is associated with a risk of developing pulmonary edema resulting from fluid overload with isotonic fluids. It is critical to
closely monitor the input and outflow of the distending liquid at all times.
Cerebral edema:
Hysteroscopic surgery is associated with a risk of developing cerebral edema resulting from fluid overload and electrolyte disturbances with
hyperosmolar (nonionic) fluids such as glycine 1.5% and sorbitol 3.0%. It is critical to closely monitor the input and outflow of the distending
liquid at all times.
Idiosyncratic reactions
In rare cases, idiosyncratic reactions, including intravascular coagulopathy and allergic reaction including anaphylaxis may occur while
performing hysteroscopy if a liquid distention medium is used. Specifically, idiosynatric anaphylactoid reactions have been reported when using
Hyskon as an irrigation fluid during hysteroscopy. These should be managed like any allergic reaction.
Hypothermia (monitoring body temperature)
Continuous flow of distention fluids can lead to a lowering of the patient's body temperature during hysteroscopic surgery. Lower body
temperatures can cause coronary and cardiovascular problems. Always monitor the patient's body temperature during the entire surgery. Make
especially sure that the following, hypothermia promoting, operation conditions are avoided as best as possible: longer operating times and use
of cold irrigation fluid.
Rupture of the fallopian tube secondary to tubal obstruction
Distention of the uterus may lead to a tear of the fallopian tube should there be an obstruction or permanent occlusion. The rupture could lead to
irrigation fluid flowing into the patient's peritoneal cavity, resulting in a fluid overload. It is critical to closely monitor the input and outflow of the
distending liquid at all times.
Original accessories
For your own safety and that of your patient, use only Fluent accessories.
Danger: explosion hazard
Do not use in the presence of a flammable anesthetic mixture. Do not use in the presence of flammable gases or liquids.
Professional qualification
This manual does not include descriptions or instructions for surgical procedures/ techniques. It is also not suitable for training physicians in
the use of surgical techniques. Medical instruments and systems may be used only by physicians or medical assistants with the appropriate
technical/medical qualification working under the direction and supervision of a physician.
Sterile media and accessories
Always work exclusively with sterile substances and media, sterile fluids, and sterile accessories, if so indicated.
8
Introduction
English