Device Purpose
7
EN
3
Device Purpose
Intended use
The SurgiQuest AirSeal® iFS System is intended for use in diagnostic and/or ther-
apeutic endoscopic procedures to distend a cavity by filling it with gas, to estab-
lish and maintain a path of entry for endoscopic instruments and to evacuate
surgical smoke. It is indicated to facilitate the use of various laparoscopic instru-
ments by filling the abdominal cavity with gas to distend it, by creating and
maintaining a gas sealed obstruction-free instrument path and by evacuating
surgical smoke. This instrument is used to insufflate the rectum and colon to fa-
cilitate endoscopic observation, diagnosis and treatment. The trocar of the
AirSeal® iFS System is indicated for use with or without visualization.
Essential performance
The device measures the actual pressure in the cavity and compares it with the
set nominal pressure. The function of this device is to maintain the nominal pres-
sure. Any overpressure within the cavity is lowered to the preset nominal pres-
sure by the automatic venting system.
Contraindications
The device should not be used to fill a cavity with CO
2
if an endoscopy is contra-
indicated. Please consult the manual of your laparoscope for absolute and rela-
tive contraindications. The device is not suitable for hysteroscopic insufflations,
i.e., it may not be used to distend the uterus.
3.1
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.
Содержание AirSeal iFS
Страница 1: ...EN Instructions for use...
Страница 4: ......
Страница 6: ...2 EN 15 AirSeal iFS Warranty 52 16 Test Log 53 16 1 Test Log 53 16 2 Return Form 54 Index 55...
Страница 20: ...16 Initial Device Startup EN House gas supply pressure OK House gas supply pressure too low...
Страница 57: ...Test Log 53 EN 16 Test Log 16 1 Test Log Date Results Comment Signature...
Страница 60: ...W55 186 EN AA...