CO
2
MPACT ENDOSCOPIC INSUFFLATOR
®
SYSTEM Operator’s Manual
Page 4
Section 2.0
INTRODUCTION
This manual provides information for the operation of the CO
2
MPACT
ENDOSCOPIC INSUFFLATOR
®
SYSTEM.
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
Hectapascal
2.1 INDICATION AND CONTRAINDICATIONS
Indications for Use:
The CO
2
MPACT ENDOSCOPIC INSUFFLATOR
®
SYSTEM
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
MPACT ENDOSCOPIC INSUFFLATOR
®
SYSTEM 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:
START/STOP button: Upon turning power on, gas flow is not initiated until the
START/STOP
button is pressed.
If the outlet pressure exceeds 375 mmHg, a fixed mechanical pressure relief valve
will open.
An audible indicator will sound when the CO
2
gas supply tank pressure is low.
Additionally, the Gas Supply Indicator LED light will turn red.
A user-adjustable automatic gas shutoff timer is present, which prevents the device
from running continuously. The shutoff timer can be set to 30, 60, or 120 minutes.
