Device-Inherent Dangers - Stryker Fluid safe Instrucciones De Uso

Purpose of the Device
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3.1

Device-inherent Dangers

The volume of the irrigation fluid entering and leaving the patient has to be
strictly monitored. When using an irrigation fluid with a low viscosity, a volume
in excess of 2 liters poses an increased risk of dangerous bacteria entering the
patient's body. The procedure should be continued only with increased vigilance.
When using an irrigation fluid with a high viscosity (e.g. Hyskon), an increased
risk of dangerous bacteria entering the patient's body exists already at only 500
ml. Please consult the user notes and instructions for Hyskon to obtain
additional information.
The pressure should be kept as low as possible to allow for a sufficient
intrauterine distension and to reduce the forces that could allow fluid, ambient
air, and/or gas into the circulatory system.
A intrauterine distention is usually possible with pressure values between 35 to
70 mm Hg. A pressure above 75 to 80 mm Hg is required only in rare cases or if
the patient has an excessively high blood pressure.
In accordance with its design purpose, the pump may be used without balancing
system only for diagnostic purposes. Pay attention to the indications for the
pump unit in the separate handbook.
Fluid Overload (Hypotone Hyperhydration)
By passing through the uterus, irrigation fluid could reach the blood system or
the patient's tissue. This could happen in the cases of overpressure, a lengthy
operation, or a perforation of the uterine cavity. The resulting disruption of the
electrolyte balance could cause TUR syndrome. The doctor bears responsibility
for the monitoring and assessment of the mentioned factors.
The decision to use the instrument detection is at the discretion of the physician.
The irrigation pressure is displayed if the instrument detection function is not
performed or the STOP key is pressed during operation. The status of the
instrument detection function cannot be displayed or loaded during surgery.
The instrument recognition may only be performed outside of the patient and at
a height of ± 10 cm (± 3.94 inches) to the height of the uterus (operation's
height).
Follow the instructions and order required to perform the instrument detection
exactly as described to prevent the display of false actual values.
Stop the device using the Start/Stop switch if replacing the instrument during
surgery.