Stryker FLUID SAFE - Device Purpose and Functionality; Intended Use and Indications for Hysteroscopy; Contraindications and Technical Application Scope; Pressure Measuring and Regulation Mechanism

Purpose of the Device
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3 Purpose of the Device
Intended useThe device is an irrigation pump with a balancing system for hysteroscopies. It is
used to introduce fluids into the uterine cavity. The device may not be used for
other endoscopic procedures. The stand and balancing system may only be used
with the accompanying pump.
IndicationsThe device is indicated for liquid distension of the uterus for diagnostic and
operative hysteroscopic procedures, and monitoring the volume differential
between the irrigation fluid flowing into and out of the uterus. Please comply
with the specific indications and instructions provided in the manual of your
endoscope.
ContraindicationsThe device may not be used to introduce fluids into the uterine cavity when a
hysteroscopy is contraindicated. See the operators manual of your hysteroscope
for absolute and relative contraindications. Relative contraindications to
endometrial ablation:
Surgical skill („Acute Technical“).
Hysteroscopic endometrial ablation, whether by laser or electrosurgery, should
not be undertaken before adequate training, preceptorship, and clinical
experience. Additionally, tissue sampling is required prior to destruction of the
endometrium. The following are clinical conditions that can significantly
complicate hysteroscopic endometrial ablation:
• Adenomatous endometrial hyperplasia
• Uterine leiomyoma
• Severe adenomyosis
• Pelvic pain (subtle PID)
• Uterine anomalies
Relative contraindications to hysteroscopic myomectomy:
• Surgical skill (see above)
• Severe anemia
• Inability to circumnavigate the myoma (re: myoma size)- predominantly
intramural myomas with small submucous components.
Technical application scope of the device The nominal pressure can be preset to ranges between 15 to 100 mm Hg and 100
to 150 mm Hg. The nominal flow can be preset to between 30 and 500 ml/min.
Pressure measuring and regulatingThis device features non-contact pressure readings of the irrigation medium. The
non-contact pressure reading is taken by integrating the pressure chamber into
the tube system. The pressure chamber transfers the tube pressure to the
device’s processing unit via two pressure sensors. The pressure control circuit
continuously compares the actual pressure with the nominal pressure. The
function of the device is to maintain the nominal pressure. If the nominal flow is
set too low, the nominal pressure cannot be reached. Check for possible leaks.