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.

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
5
Section 3.0
INSUFFLATOR THEORY OF OPERATION
The PROTOCO
2
L™Colon Insufflator operates by
administering CO
2
at a maximum
flow rate of 3 LPM, and then monitoring the current colonic pressure. A value for
colonic pressure is selected by the operator, turning the Pressure Adjust Dial on the
front panel. Once started, the colonic pressure will grad
ually increase and will be
displayed on the Pressure Display on the front panel. The flow of CO
2
will gradually
decrease when the current pressure approaches the user determined value (on the
Pressure Adjust Dial). The colonic pressure has stabilized when
the pressure shown
on the Pressure Display equals the pressure set on the Pressure Adjust Dial and the
flow of CO
2
will stop. While in the RUN mode, the PROTOCO
2
L™Colon
Insufflator will maintain the selected colonic pressure by continuously monitoring
the current colonic pressure and will compensate for a loss in the colonic pressure by
allowing additional CO
2
to flow until the current pressure is equal again to
the user
determined colonic pressure setting.
The PROTOCO
2
L™Colon Insufflator has an electronically controlled Pressure
Relief Valve at 50 mm Hg and an independent redundant mechanical Pressure Relief
Valve pre
-
set to 75 mm Hg. Both pressure relief safet
y devices are active whether
the Gas Flow is on or off.

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
6
Section 4.0
WARNINGS AND CAUTIONS
This section describes warning and caution information for safe operation of the
PROTOCO
2
L™Colon Insufflator. All information in this manual, and particularly
in this section,
should be read thoroughly and understood before using the device.
4.1
WARNINGS

If pneumoperitoneum (free intra
-
peritoneal air) is observed, or if colonic perforation
is suspected at any time during the use of PROTOCO
2
L insufflator, immediately
discontinue use
and provide appropriate medical treatment.

Prior to use, be sure to read all instructions for use on the PROTOCO
2
L
Administration Set.

Excessive absorption of CO
2
results from either excessive flow rate and/or excessive
pressure. The colon can be adequat
ely distended by pressure in the range of 15 to
25
mm Hg. Use of pressure less than or equal to 25 mm Hg will dramatically reduce
the likelihood of intravasation of CO
2
gas into open vascular channels. Also,
adequate respiration helps avoid problems relat
ed to CO
2
.

Should accidental intravasion of CO
2
occur, in rare circumstances, it can result in
embolization.

Infusion of CO
2
can result in carbonic acid irritation to directly contacted tissues.

Use only USP “Medical Grade” CO
2
available in “D/E” supply ta
nks

Equipment is not suitable for use in the presence of a flammable anesthetic mixture
with air, oxygen, or nitrous oxide.

Never attempt to service the device when it is connected to a power source.
Hazardous voltages inside the device can cause severe e
lectrical shock. Disconnect
the power cord before servicing.

Ensure that all high
-
pressure gas line connections are secure before opening the gas
source(s). Loose connections could separate unexpectedly with great force, causing
personal injury.

This devic
e should be operated only by or under the direct supervision of a licensed
physician experienced in colon insufflation. The user should be thoroughly familiar
with the operation of this device prior to use. Additionally, individuals using this
device must
be alert and attentive to the operation of the system while it is connected
to the patient. Diligence on the part of the operator is an essential requirement of
overall device safety.

To avoid the risk of electrical shock, connect the power cord to a prop
erly wired
grounding receptacle only.

To prevent unit contamination and patient cross
-
contamination, use only E
-
Z
-
EM’s
PROTOCO
2
L™Administration Set which includes a 0.1 micron hydrophobic filter.

Idiosyncratic reactions: In patients with sickle cell dise
ase or pulmonary
insufficiency, use of these devices may pose increased risks of metabolic imbalance
related to excessive CO
2
absorption.

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
7

Always instruct the patient to immediately notify the operator of any pain
experienced during the procedure.

If an eme
rgency should arise whereby the need to terminate insufflation is required,
operators should stop the gas flow by promptly disconnecting the PROTOCO
2
L™
Administration Set at the Insufflator Output Port.

The PROTOCO
2
L™Colon Insufflator can release CO
2
to the surrounding
atmosphere in the event of misuse or a fault condition. Use and store the
PROTOCO
2
L™Colon Insufflator in a well ventilated environmen
t. Additionally,
make sure all CO
2
supply tank connections are correctly installed and free of visible
damage. Should an unexplained rapid discharge of CO
2
occur, evacuate the
immediate area until it has had sufficient time to ventilate.

High Pressure USP
CO
2
is supplied to the PROTOCO
2
L™Colon Insufflator from
commercially available CO
2
supply tanks. Please read and carefully follow all
Warnings, Cautions and Handling Instructions provided with, and listed on these
CO
2
supply tanks that are used with the PROTOCO
2
L™Colon Insufflator. Fa
ilure to
do so can result in Serious Injury or Death.

This product contains phthalates which have been perceived as having possible
carcinogenic, mutagenic and reproductive risks. However, based on all existing
scientific data, the long history of safe u
se of medical device products containing
phthalates, as well as the short duration of contact with this device, there are no
known cancer or reproductive risks to humans. Physician discretion is required to
ensure that benefits outweigh risks when this dev
ice is used in children, elderly and
pregnant women.
4.2
CAUTIONS

Do not allow fluids to enter the device.

The cabinet should not be opened except by a qualified service person. Tampering
by unqualified persons can damage the unit and void the warranty.

Verify
proper connection of tubing before using the unit.

This device has not been tested for MR compatibility, and should not be introduced
into the MR exam room.

Do
Not
attempt to use this system until you have completed all the steps in
“Assembly Prior to Col
on Insufflation” Section 9.0 and “Setting
-
Up for the
Procedure” Section 10.0. If the equipment differs significantly in appearance or
operation from the way it is presented in this manual, or you have any doubts what
-
so
-
ever concerning its installation or
operation, inform E
-
Z
-
EM, Inc. Customer
Solutions at 1
-
800
-
544
-
4624 (USA), 1
-
516
-
333
-
8230.

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
8
Section 5.0
DESCRIPTION OF EQUIPMENT
The PROTOCO
2
L™Colon Insufflator is indicated for use as a means of providing
colonic distention.
5.1
SPECIFICATIONS
Size:
10” wide x 5.50” high x 10” deep.
254 mm x 140 mm x 254 mm
Weight:
Less than 20 lb. (9.0 kg)
Control Panel:
Push
-
buttons and rotary dial. Digital
pressure and
volume readouts.
Gas Flow
:
0 to 3 LPM
Pressure Adjustment:
0 to 25 mm Hg operating.
Pressure Relief Valve:
Electronic controlled relief of pressure at 50 mm Hg
for 5 seconds. Fixed mechanical pressure relief at
75 mm Hg. Both reliefs are
active whether gas flow is
on or off for added protection. Audible alarm will
sound at the time of actuation of the electronic pressure
relief at 50 mm Hg.
Operating modes:
FLOW STOP/RUN
Gas Inlet:
Single “D/E”
CO
2
supply
tank.
WARNING:
Do not allow
liquid CO
2
to enter the unit. This can be prevented by assuring that
the CO
2
supply tank is maintained in a vertical position at all times.
Gas Input Pressure
:
75 to 2200 PSI, flow to 25 PSI.
Patient Set:
Available for use with 0.1 micron hydrophobic fil
ter.
E
-
Z
-
EM, Inc. supplies an Administration Set that
includes this filter.
5.2
ELECTRICAL REQUIREME
NTS
Input Voltage:
100 to 240 VAC nominal line voltage; 50/60 Hz.
(line voltage can vary by ±10% from nominal)
Power:
25 watts, double fusing with removabl
e power cord
Standards:
UL
-
2601
-
1; IEC
-
601
-
1; IEC
-
601
-
1
-
2; EN55011;
EN60601
-
1
-
2; EN50082
-
1; EN61000
-
4
-
2
-
3
-
4
-
5
-
6
-
8
-
11,
EN61000
-
3
-
2
-
3.

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
9
5.3
UL
EQUIPMENT CLASSIFICA
TION
Underwriter’s Laboratories/CSA
Class I Type B
5.4
ENVIRONMENTAL REQUIR
EMENTS
Operating Temperature
:
50° to 104° F (10° to 40° C)
Operating Relative Humidity:
30 to 70% non
-
condensing
Operating Pressure:
700 to 1060 hPa
20.7
to 31.3 (inches of Mercury)
Storage Temperature:
32° to 160° F (0° to 70° C)
Storage Relative Humidity:
20 to 90% non
-
c
ondensing
Storage Pressure:
500 to 1060 hPa
14.8
to 31.3 (inches of Mercury)
Not to be used in the presence of flammable gases.
NOTE:
This unit has not been tested for MR compatibility and should not be
introduced into the MR exam room.