Users Manual

General Information
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3 General Information
3.1 Device Description
The device
PNEUMOCLEAR™
is an insufflator and serves to create a cavity through
the insufflation of CO
2
with a preset flow rate and pressure. The gas will be trans-
ported to the patient via a tube connected with a trocar. The insufflator limits the
pressure to a maximum of 30mmHg and the flow rate to a maximum of 50l/min.
The device can be operated in different operating modes which are intended to suit
different surgical procedures and/or different patient’s physical characteristics.
The following table describes the different operating modes.
Operating mode Description Patients Population
Standard operating mode
used to distend the peritoneal
cavity during laparoscopic pro-
cedures by insufflating CO
2
.
designed for laparoscopies per-
formed on normal weight and
slightly obese (BMI < 30 kg/m
2
)
patients over the age of 14.
High Flow/Bariatric operating
mode
used to distend the peritoneal
cavity during laparoscopic pro-
cedures by insufflating CO
2
.
designed for laparoscopies per-
formed on normal weight and
obese patients (BMI>30kg/m
2
)
over the age of 14.
Pediatric operating mode
used to distend the peritoneal
cavity during laparoscopic pro-
cedures by insufflating CO
2
.
designed specifically for use on
newborns, infants, and children
under the age of 14.
Advanced Flow operating mode
used to distend the peritoneal
cavity during laparoscopic pro-
cedures, including but not lim-
ited to robotic-assisted laparo-
scopies by insufflating CO
2
.
designed for laparoscopies per-
formed on normal weight and
obese patients over the age of
14.
Vessel Harvest operating mode
used to distend the cavity along
the vena saphena magna and ra-
dial artery during an endoscopic
vessel harvesting procedure.
designed for patients over the
age of 14.
TAMIS operating mode
used to dilate and fill the rectum
and colon by insufflating CO
2
during transanal minimally in-
vasive surgery.
designed for patients over the
age of 14.
Essential performanceThe device measures the actual pressure in the cavity and compares it to the set
nominal pressure. The function of this device is to maintain the nominal pressure.
Overpressure within the cavity is lowered to the preset nominal pressure by the
automatic venting system.
Additional optional features are available to increase user and patient comfort:
1. Integrated gas heater to heat the insufflation gas.
2. Suction function to evacuate surgical smoke from the cavity.
3. Humidification of the insufflation gas.
These features become available by use of the appropriate tube sets, see Chapter
Insufflation Tube Sets [
}28].
The insufflator is a pneumatic device that works through the port on the back, with
central gas as well as bottled gas. It is operated via buttons and indicators or dis-
plays on the front of the device. Optionally, the device can be operated via remote
access and a central device control, either by voice control or a remote touch panel.
3.2 Intended Use and Contraindications
3.2.1 Intended Use
The device
PNEUMOCLEAR™
is a CO
2
- insufflator intended for use during diagnostic
and/or therapeutic endoscopic procedures to distend a cavity by filling it with CO
2
gas. The operating modes
Standard
,
High Flow/Bariatric
,
Pediatric
and
Advanced
Flow
of the device are indicated to fill and distend a peritoneal cavity with gas dur-
ing a laparoscopic procedure. The
Pediatric
operating mode is indicated for pediat-
ric laparoscopic procedures. The
Vessel Harvest
operating mode is indicated for use
en
DRAFT