Safety Notes

Using the Urology Indication
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11.1 Device-inherent Dangers: Urology Indication
WARNING!
Instrument replacement
Stop the device using the START/STOP switch if replacing the instrument during
surgery.
WARNING!
Fluid volume/sodium concentration
The fluid left in the patient and the concentration of sodium in the blood serum
must both be monitored. The deficit amount is the entire amount of fluid lost by
or to the system. Take note of the measurement tolerance of the system. Esti-
mating the fluid volume remaining in the patient is the physician’s responsibili-
ty.
WARNING!
If a stone is in the surgical field, it can be moved by the flow of irrigation fluid
settable via the pressure and flow rate values and possibly flushed into the kid-
neys.
WARNING!
Idiosyncratic reactions
In rare cases, idiosyncratic reactions such as
• intravascular coagulopathy
• allergic reaction including anaphylaxis
may occur during a surgical procedure if a liquid distention medium is used.
WARNING!
Pulmonary edema
A surgical procedure has the risk of pulmonary edema, which is formed due a
"fluid overload" with isotonic fluids. It is critical to closely monitor the input and
outflow of the distending liquid at all times.
WARNING!
Cerebral edema
A surgical procedure has the risk of cerebral edema resulting 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!
Fluid intake and output surveillance
Strict fluid intake and output surveillance should be maintained. If a low viscos-
ity liquid is used, a transurethral instillation exceeding 2 liters must be moni-
tored with great care due to the possibility of fluid overload.
WARNING!
Hyponatremia
Some distension fluids may lead to fluid overload and, consequently, hyponatre-
mia with its attending sequelae. This can be affected by the distending pressure,
flow rate, and duration of hysteroscopic procedure. It is critical to closely moni-
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