Purpose of the System
EN
WARNING!
Cerebral edema
Hysteroscopic surgery is associated with a risk of developing cerebral edema re-
sulting from fluid overload and electrolyte disturbances with hypoosmolar (non-
ionic) 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.
WARNING!
Idiosyncratic reactions
In rare cases, idiosyncratic reactions, including:
• intravascular coagulopathy
• allergic reaction including anaphylaxis
may occur while performing hysteroscopy if a liquid distention medium is used.
Specifically, idiosynatric anaphylactoid reactions have been reported when us-
ing Hyskon as an irrigation fluid during hysteroscopy. These should be managed
like any allergic reaction.
WARNING!
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 tem-
perature during the entire surgery. Make especially sure that the following, hy-
pothermia promoting, operation conditions are avoided as best as possible:
• longer operating times
• use of cold irrigation fluid.
WARNING!
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 crit-
ical to closely monitor the input and outflow of the distending liquid at all times.
WARNING!
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 pre-
vent air from being pumped into the patient.
WARNING!
The system is only intended for use with flexible fluid containers. Do not use
glass containers as they might break. With rigid containers, fluid cannot flow
quickly enough due to the vacuum being generated inside of the containers. Risk
of implosion with rigid containers.
WARNING!
Filling the tubing with irrigation fluid and resetting the deficit display to zero are
to be done at the physician's discretion.
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