EZ EM PROTOCO2L 6400 User manual

Rx Only (USA)
COLON INSUFFLATOR
REF
6400
Operator’s Manual
0086

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
2
TABLE OF CONTENTS
SECTION 1.0
UNPACKING AND GENERA
L INSPECTION …………………
………………
3
SECTION 2.0
INTRODUCTION..………………
………………………………………………….
..
4
2.1
INDICATION AND CONTRAINDICATIONS
................................
................................
.......
4
2.2
SAFETY FEATURES
................................
................................
................................
................
4
SECTION 3.0
INSUFFLATOR THEORY O
F OPERATION
................................
........................
5
SECTION 4.0
WARNINGS AND CAUTION
S
................................
................................
.................
6
4.1
WARNINGS
................................
................................
................................
................................
6
4.2
CAUTIONS
................................
................................
................................
................................
.
7
SECTION 5.0
DESCRIPTION OF EQUIP
MENT
................................
................................
...........
8
5.1
SPECIFICATIONS
................................
................................
................................
....................
8
5.2
ELECTRICAL REQUIREMENTS
................................
................................
..........................
8
5.3
UL
EQUIPMENT CLASSIFICATION
................................
................................
....................
9
5.4
ENVIRONMENTAL REQUIREMENTS
................................
................................
................
9
SECTION 6.0
FRONT PANEL CONTROLS
................................
................................
.................
10
SECTION 7.0
REAR PANEL CONTROLS
................................
................................
...................
12
SECTION 8.0
HIGH PRESSURE HOSE A
ND YOKE ASSEMBLY
................................
..........
13
SECTION 9.0
ASSEMBLY PRIOR TO CO
LON IN
SUFFLATION
................................
...........
14
9.1
INSUFFLATOR PREPARATION
................................
................................
..........................
14
9.2
ELECTRICAL CONNECTIONS
................................
................................
...........................
14
9.3
CO
2
HOSE CONNECTIONS
................................
................................
................................
..
15
SECTION 10.0
SETTING
-
UP AND PERFORMING TH
E PROCEDURE
................................
..
17
10.1
POWER ON AND GAS SUPPLY INDI
CATOR
................................
................................
...
17
10.2
PREPARATION TEST
................................
................................
................................
............
17
10.3
SETTING PATIENT PRESSURE
................................
................................
..........................
18
10.4
RESET CO
2
VOLUME
................................
................................
................................
............
18
10.5
PATIENT CONNECTION FOR INSUFFLATION
................................
..............................
18
10.6
ADMINISTRATION SET CONNECTION FOR INITIAL INSUFFLAT
ION
..................
18
10.7
PATIENT INSUFFLATION
................................
................................
................................
....
19
10.8
OBSERVATIONS DURING INSUFFLATION
................................
................................
....
19
10.9
CO
2
VOLUME DISPLAY
................................
................................
................................
........
21
10.10
TERMINATING GAS FLOW & SHUT
-
DOWN PROCEDURES
................................
.....
21
SECTION 11.0
DECONTAMINATION, CLE
ANING AND STORAGE
................................
......
22
SECTION 12.0
REPAIR
................................
................................
................................
....................
23
12.1
CUSTOMER SOLUTIONS AND ORDERING INFORMATION
................................
......
23
12.2
WARRANTY
................................
................................
................................
.............................
23
12.3
CERTIFICATION OF NON
-
CONTAMINATION
................................
..............................
24
SECTION 13.0
CERTIFICATE OF NON
-
CON
TAMINATION
................................
...................
25
SECTION 14.0
TROUBLESHOOTING GUID
E
................................
................................
.............
26
SECTION 15.0
EMC TABLES
................................
................................
................................
...........
35

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
3
Section 1.0
UNPACKING AND GE
NERAL INSPECTION
CAUTION:
READ ALL SECTIONS OF THIS MANUAL CAREFULLY BEFORE USING
PROTOCO
2
L™COLON INSUFFLATOR, SUCH THAT OPERATION IS
UNDERSTOOD. IF YOU SHOULD HAVE ANY QUESTIONS, PLEASE
CONTACT E
-
Z
-
EM, INC. CUSTOMER SOLUTIONS AT 1
-
800
-
544
-
4624,
516
-
333
-
8230 OR YOUR LOCAL E
-
Z
-
EM, INC. REPRESENTATIVE.
Proper care and maintenance are critical for safe operation of sophisticated medical
equipment. We recommend careful inspection of all equipment upon receipt and
prior to each use as a safeguard against poss
ible injury to patient or operator.
To avoid inadvertent damage, study this manual thoroughly before handling,
assembling, testing, using, or cleaning the PROTOCO
2
L™Colon Insufflator.
Examine the shipping carton and instrument for signs of damage. Any breakage or
other apparent damage should be noted, the evidence retained, and the carrier or
shipping agency notified.
Verify that the shipping carton contains the it
ems listed below:
PROTOCO
2
L™Colon Insufflator
Operator’s Manual
Quick Reference Guide
Power Cord (see CAUTION below)
High Pressure Hose &
Yoke
Notify E
-
Z
-
EM, Inc. Customer Solutions immediately if any damage or
discrepancies are noted.
Phone: 1
-
800
-
544
-
4
624 (USA), 1
-
516
-
333
-
8230
CAUTION:
The line cord (mains lead) supplied with this unit is designed and approved for use in
the USA and Canada only, and should not be used outside these countries. For use
outside of the USA and Canada, your Distributor w
ill supply a line cord that is
approved for use in your country.

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.