CO
2
EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual
Page 4
Section 2.0 INTRODUCTION
This manual provides information for the operation of the CO
2
EFFICIENT
ENDOSCOPIC INSUFFLATOR, (also referred to in this manual as "unit" or
"device").
DEFINITIONS
The following list is abbreviations of commonly used terms throughout this manual:
LPM
Liter Per Minute (or Liters Per Minute)
mm Hg
millimeters of Mercury
gas
CO2
hPa
Hundred Pascal
2.1 INDICATION AND CONTRAINDICATIONS
Indications for Use:
The CO
2
EFFICIENT ENDOSCOPIC INSUFFLATOR is
designed to use CO
2
as a distention media in the gastrointestinal tract when used in
conjunction with a gastrointestinal endoscope.
Contraindications for Use:
The CO
2
EFFICIENT ENDOSCOPIC INSUFFLATOR should be used only for an
endoscopic procedure when insufflation of the gastrointestinal tract is necessary to
support navigation of the endoscope and perform any evaluation procedures through
the endoscope, and should therefore not be used for any other treatments. It should
only be used under the direct guidance of a physician experienced in Gastrointestinal
Endoscopy procedures.
This device is
contraindicated
for hysteroscopic
or laparoscopic
insufflation, i.e., it
must not be used for intrauterine distension.
This device is
contraindicated
for CT Colonography.
2.2 SAFETY FEATURES
The following features help to ensure safe operation of the machine:
FLOW STOP/RUN button: Upon turning power on, gas flow is not initiated until the
FLOW STOP/RUN
button is pressed.
An initial pressure relief will occur at 375 mm Hg and a redundant pressure relief
will occur at 400 mm Hg.
An audible alert will sound when the CO
2
gas supply tank pressure is low.
An audible alert (a single chirp) will sound when the flow of CO
2
is automatically
stopped by the device.
