Safety Notes
Using the Hysteroscopy Indication
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10 Using the Hysteroscopy Indication
Intended use: HysteroscopyThe devices PG130/PG145 may be used for intrauterine distension, aspiration of
secretory fluids, and monitoring of fluid deficit during endoscopic procedures. It
is used to irrigate the cavum uteri with fluid to prepare for diagnostic and surgi-
cal hysteroscopies. The devices also offer the option of monitoring the volume
difference between the fluid injected into the uterus and the fluid draining from
the uterus (balancing).
The devices PG130/PG145 without fluid balancing may only be used for diagnos-
tic purposes.
ContraindicationsThe devices may not be used to introduce fluids into the cavum uteri when a hys-
teroscopy is contraindicated.
Relative contraindications to endometrial ablation: Surgical skills ("Acute Techni-
cal").
Technical application scope: HysteroscopyThe following characteristics apply to the hysteroscopy indication:
• The nominal pressure can be preset to a range of 15 to 150 mmHg.
• The nominal flow has 2 settings, LO and HI. The nominal flow levels can be pre-
set to the following ranges in the user menu:
– LO = 50-200 ml/min
– HI = 200-500 ml/min
• The pump reacts to pressures greater than the set nominal pressure by emit-
ting warnings. The devices have safety thresholds.
• The pump reacts to reaching and exceeding the deficit threshold by emitting
warnings.
• The pump reacts to perforation (exceeding the deficit threshold) by emitting
warnings.
• The pump reacts to a scale defect by emitting warnings.
10.1 Device-inherent Dangers: Hysteroscopy Indication
WARNING!
When using the scale, follow the operating instructions in this 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 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 is used, the use of more than 500 ml should be followed with
great care.
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