EZ EM PROTOCO2L 6400 - INTRODUCTION; Indications and Contraindications; Safety Features

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
4
Section 2.0
INTRODUCTION
This manual provides information for the operation of the PROTOCO
2
L™ Colon
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
CO
2
2.1
INDICATION AND CONTR
AINDICATIONS
Indications for Use:
The PROTOCO
2
L™ Colon Insufflator administers and
regulates carbon dioxide as a distention media to the colon during CT Colonography
(CTC or Virtual Colonoscopy) and conventional Colonoscopy.
Contrain
dications for Use:
The PROTOCO
2
L™ Colon Insufflator should be used only when colon insufflation
is indicated, and should therefore not be used for any other treatments. It should only
be used under the direct guidance of a physician experienced in colon in
sufflation.
This device is
contraindicated
for hysteroscopic
insufflation, i.e., it must not be
used for intrauterine distention.
This product should not be used in patients with known or suspected colonic
perforation or toxic megacolon, It should not be
used within 6 days of large forceps
or “hot” biopsy, or snare polypectomy.
Do not use this product in a colostomy stoma.
Do not use this product following recent rectal surgery or low rectal anastomosis, or
when proctitis or other rectal conditions such as
inflammatory or neoplastic diseases
are suspected.
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.
T
he electrical pressure relief will occur when 50 mm Hg is reached and sustained for
5 seconds. An audible alarm will sound during actuation of the electronic pressure
relief at 50 mm Hg. Additionally, the PRESSURE display will flash.
A fixed mechanical pr
essure relief occurs at 75 mm Hg.
An audible alarm will sound when the CO
2
gas supply tank pressure is low.
Additionally, the Gas Supply Indicator bar graph display will flash.