Device Purpose; Device-Inherent Dangers - Surgiquest AirSeal i.F.S. Gebrauchsanweisung

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Device Purpose

The SurgiQuest AirSeal® i.F.S. Intelligent Flow System (hereafter referred to as
AirSeal® i.F.S.) is intended for use in diagnostic and/or therapeutic endoscopic
procedures to distend the peritoneal cavity by filling it with gas, to establish and
maintain a path of entry for endoscopic instruments and to evacuate surgical
smoke. The cannula of the AirSeal® i.F.S. is indicated for use with or without visu-
alization.
The device should not be used to fill an abdomen with CO
traindicated. Please consult the manual of your laparoscope for absolute and rel-
ative contraindications. The device is not suitable for hysteroscopic insufflations,
i.e., it may not be used to distend the uterus.
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Device-inherent Dangers

WARNING!
Positioning the patient
Positioning the patient lower than the device can prevent body fluids from leak-
ing into the tube set. Actual pressure may increase and fluid may penetrate the
insufflation tube if the patient is repositioned during surgery.
WARNING!
Removing the insufflation tube
When insufflation is no longer required, press "stop" and disconnect the insuffla-
tion tubing when appropriate.
WARNING!
Backflow
Body secretions or contaminated gas may backflow into the device through the
insufflation tube set if
• a filter is not used,
• the actual pressure is higher than the nominal pressure or
• the automatic venting valve is activated.
WARNING!
Gas flow
A high gas flow can occur due to large leaks within the surgical system or instru-
ment. This can result in a false actual pressure reading, which in turn may endan-
ger the patient. In case of a disrupted gas flow, you should therefore inspect
device, tube, and instruments immediately. Surgical procedures should be per-
formed with a gas flow of 4 to 10 l/min. An even lower gas flow is recommended
for diagnostic purposes.
WARNING!
Gas supply
Maintain adequate gas supply at all times.
WARNING!
Contamination
Do not use device and/or accessories if signs of contamination are detected.
Make sure the device or/and accessories can no longer be operated until a qual-
ified service technician conducts the appropriate tests and repairs.
Intended use
if a laparoscopy is con- Contraindications
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Device Purpose
EN
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