Use Instructions
36
Using the Hysteroscopy Indication
EN
9 Using the Hysteroscopy Indication
Intended use: Hysteroscopy Uterine distention, fluid aspiration and monitoring of fluid deficit during diag-
nostic and operative procedures.
Contraindications The device may not be used to introduce fluids into the cavum uteri when a hys-
teroscopy is contraindicated.
Technical application scope: Hysteroscopy The following characteristics apply to the hysteroscopy indication:
• The nominal pressure can be set within a range of 15 to 150 mmHg.
•The
maximum flow range (max. flow) can be set in the range of 50 to 800 ml/min
.
• The device features an optional instrument recognition function.
• The pump reacts to pressures greater than the set nominal pressure by emit-
ting warnings. The device features safety thresholds.
• The pump reacts by emitting warnings when the deficit limit is reached or ex-
ceed.
• The pump reacts to perforation or high fluid loss (exceeding the deficit thresh-
old) by emitting warnings.
9.1 Device-Inherent Dangers: Hysteroscopy Indication
WARNING!
When using the fluid monitoring unit, follow the operating instructions in this
user manual.
WARNING!
The deficit and inflow values are lost in case of a power loss or "brownout".
WARNING!
Intrauterine distention is usually possible with pressure values between 35 to
70 mmHg. A pressure above 75 to 80 mmHg is required only in rare cases or if the
patient has an excessively high blood pressure.
WARNING!
Fluid intake and output surveillance
Strict fluid intake and output surveillance should be maintained. If a low viscos-
ity fluid distention medium is used, intrauterine instillation exceeding 2 liters
should be followed 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-
tor the input and outflow of the distending liquid at all times.
WARNING!
Pulmonary edema
A surgical procedure has the risk of pulmonary edema, which is formed due a
"fluid overload" with isotonic fluid. It is critical to closely monitor the input and
outflow of the distending liquid at all times.