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.

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
10
Section 6.0
FRONT P
ANEL CONTROLS
NOTE
: The appearance of your
PROTOCO
2
L™Colon Insufflator may differ slightly from the units
shown in the illustrations and photographs. (Example: buttons may be round or square).
[1]
GAS SUPPLY INDICATOR
Three colors of LED’s to indicate the relative amount of gas available in a "D/E"
CO
2
s
upply tank.
[2]
VOLUME LITERS DISPLAY
Indicates the total amount of gas used.
[3]
VOLUME RESET
Clears the volume display to zero.
[4]
FLOW STOP/RUN
Depression starts flow. Unit will flow at 1 to 3 LPM based on volume delivered.
Flow is incrementally delive
red during first Liter: delivery volume from 0 to 0.5
Liter at 1 LPM maximum, delivery volume greater than 0.5 to 1 Liter at 2 LPM
maximum and delivery volume greater than 1 Liter at 3 LPM.
Upon pressing the FLOW STOP/RUN button at the start of the proce
dure, the
unit will remain in run mode until 4 Liters of CO
2
have been delivered. Once 4
Liters have been delivered, the unit automatically returns to stop mode.
Thereafter pressing the FLOW STOP/RUN button a second time will resume the
delivery of CO
2
for
an additional 2 Liters of CO
2
. Once an additional 2 Liters
have been delivered, the unit automatically returns to stop mode.
Subsequent presses of the FLOW STOP/RUN button will deliver additional
2 Liter boluses of CO
2
as required by the user.
The user
can always depress the STOP/RUN button during any of these volume
increments to stop delivery of CO
2
.

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
11
NOTE:
Flow cannot be initiated if gas bottle pressure is less than 25 PSI.
[5]
PRESSURE ADJUST AND DISPLAY
270° rotary control. Dial shows pressure se
t point. Allows the user to select
between 0 to 25 mm Hg. Display shows pressure.
[6]
GAS OUTPUT CONNECTION TO PATIENT
Connector for patient tubing set.
[7]
POWER SWITCH
Turns the power on and off to the machine.

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
12
Section 7.0
REAR PANEL CONTROLS
[8]
G
AS INPUT PORT
For connecting a “D/E” supply tank using the High Pressure Hose and Yoke
assembly provided.
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.
[9]
AC POWER CONNECTION
Universal AC line input device
–
nominal AC line voltage 100 to 240 VAC
frequency 50/60 Hz. The AC line voltage should not drop below 90 VAC or
exceed 264 VAC. There are no switches or other AC line configuration
r
equirements.
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 will supply a line cord
tha
t is approved for use in your country.
AC input is with a standard hospital grade power cord. Connection should be to
hospital grade receptacles only.

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
13
Section 8.0
HIGH PRESSURE HOSE AND YOKE ASSEMBLY
The assembly consists of the YOKE as shown in Figure 8.1 and the H
IGH
PRESSURE HOSE as shown in Figure 8.2.
NOTE:
Before proceeding to the next step, check for the presence of the plastic
gasket on the inside of the yoke (arrow on Figure 8.1).
Figure 8.2
Figure 8.1

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
14
Section 9.0
A
SSEMBLY PRIOR TO COLON INSUFFLATION
IMPORTANT
If at any time the unit performs erratically or provides otherwise abnormal operation,
remove the unit from service and have it inspected or repaired.
The PROTOCO
2
L™Colon Insufflator should be inspected upon receipt and before
each use. Damaged equipment should be removed from service and returned to
E
-
Z
-
EM, Inc. for repair or replacement. Before each use, perform the procedures and
inspections described in Sectio
ns 9.1, 9.2 and 9.3
9.1
INSUFFLATOR PREPARATION
1.
Install the PROTOCO
2
L™Colon Insufflator on the Accessory Cart, or on a flat
surface, away from potential sources of spraying or leaking liquids.
2.
Visually inspect the PROTOCO
2
L™Colon Insufflator for exter
nal signs of
damage.
9.2
ELECTRICAL CONNECTIONS
1.
Inspect the electrical connections. Do not use if inspection reveals any damage.
2.
Connect the Power Cord to the AC Power Connection on the back of the
PROTOCO
2
L™Colon Insufflator.
3.
Before connecting the p
ower cord to the hospital grade wall outlet, make sure
that the main power switch is off and that the voltage is correct. The
PROTOCO
2
L™Colon Insufflator has a universal AC line input device, the
nominal AC line voltage is 100 to 240 VAC and the AC line f
requency is
50/60
Hz. The AC line voltage should not drop below 90 VAC or exceed
264 VAC. There are no switches or other AC line configuration requirements.

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
15
9.3
CO
2
HOSE CONNECTIONS
1.
If not already connected, assemble the High Pressure Hose and Yoke using
a
9/16
″ open
-
end wrench on the hose fitting and a ¾
″ Open Ended wrench on the
Yoke’s hexagonal shaped surface. The complete Hose
-
Yoke assembly is shown
in Figure 9.1. Identify the post valve Yoke positioning holes on the CO
2
supply
tank (Tank not provided with s
ystem), as shown in Figure 9.2.
2.
Slide the Hose
-
Yoke assembly over the top of the post valve and align the two
positioning pins from the Yoke with the two locating holes from the CO
2
supply
tank post valve. Insert the pi
ns into the locating holes and tighten the Yoke on
the post valve with the T
-
handle provided with the Yoke. Place the valve wrench
included with cart (see Figure 9.3), or equivalent open
-
end/adjustable wrench, on
the valve stem as shown in Figure 9.4
3.
Remove cap from the CO
2
Input port on back of Insufflator. Tighten the other
end of the High
-
Pressure Hose to the CO
2
Input port on the back of the Unit
using a 9/16
″ open
-
ended
wrench
(see Figure 9.5).
Figure
9
.4
Figure
9
.3
Figure
9
.1
Figure
9
.2
Figure
9
.5
NOTE:
Do not use any teflon tape or
thread sealing compounds on any
connection
.

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
16
WARNIN
G:
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 upright position at all times.
USE ONLY MEDICAL GRADE CO
2
SIZE “D” OR “E” supply tanks.
Before each use the following pro
cedures or inspections should be performed:
Visually inspect the PROTOCO
2
L™Colon Insufflator for external signs of damage.
Inspect the electrical connections. Do not use if inspection reveals damage.
Before connecting the power cord to the wall outlet, make sure the main power
switch is off and that the voltage is correct.
In
spect the connection to the CO
2
supply tank, to assure it is intact and tight.
NOTE: To assure maximum life of CO
2
supply tank, always close CO
2
tank from the
post valve when not in use.

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
17
Section 10.0
SETTING
-
UP AND PERFORMING THE
PROCEDURE
10.1
POWER ON AND GAS SU
PPLY
INDICATOR
1.
Open the valve on the CO
2
supply tank approximately 1 turn. Turn on the Power
Switch. Upon turn on, all lights and indicators will be illuminated for a brief
period.
2.
The Gas Supply indicator should display red
-
yellow
-
green bars. The color
c
oding in the bar graph is a guide to determine whether there is sufficient gas in
a “D/E”
CO
2
supply tank to finish a procedure, as indicated below:
Lights
Available CO
2
Gas
Green
Tank Pressure is greater than 175 PSI.
Yellow
Tank Pressure is 75 to 17
5 PSI.
Red
Tank Pressure is less than 75 PSI. Change Tank!
NOTE:
If CO
2
supply tank pressure is less than 25 PSI (red), flow cannot be
initiated.
10.2
PREPARATION TEST
There is always the possibility that delicate equipment can be damaged in
transportation
or storage. Therefore it is important to verify proper operation of the
unit before use.
1.
After power is applied to the unit, verify that the front panel lights are enabled.
NOTE:
If the output pressure is negative or in an alarm state, the Pressure Dis
play
will indicate the actual pressure.
2.
To verify that flow control is functioning properly, depress the FLOW
STOP/RUN button. When pressed, the light in the switch should light, and gas
may be heard exiting from the unit. If gas does not begin flowing,
verify that the
CO
2
supply tank valve is in the open position (see
Power On and Gas Supply
Indicator
, #1, above).
3.
To verify that the Pressure Adjust and Display are functioning properly, block
off the Output connector, and rotate the Pressure select di
al through the entire
range of 0 to 25 mm Hg. Verify a pressure increase on the Pressure Display.
4.
When the FLOW RUN/STOP button is pressed initially, 4 Liters of CO
2
are
delivered and the unit automatically returns to STOP mode. Thereafter,
subsequent p
resses of the FLOW STOP/RUN button will resume the delivery of
CO
2
for an additional 2 Liters before automatically returning to STOP mode.
However, you can stop the flow using the FLOW STOP/RUN button while the
unit is in RUN mode, as evidenced by the illu
minated FLOW STOP /RUN
button.
5.
If the unit does not perform properly, do not use. Inspect the unit using the
Troubleshooting guide (Section 14.0) before returning for service.

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
18
10.3
SETTING PATIENT PRE
SSURE
To set patient pressure, rotate the Pressure Se
lect dial to the desired pre
-
set pressure.
Once flow has been initiated, the pressure display will indicate the current pressure
value.
An initial insufflation pressure of 20 mm Hg is recommended. If necessary, the
pressure may be increased up to 25 mm H
g during the procedure to obtain adequate
distention.
10.4
RESET CO
2
VOLUME
Assure that the Volume Display reads zero prior to beginning insufflation. To reset
the Volume Liters Display, press the Volume Reset.
NOTE: Do not press Volume Reset button once pr
ocedure has started.
10.5
PATIENT CONNECTION
FOR INSUFFLATION
Place the patient in the lateral decubitus position, and insert the Administration Set into the patient,
following the instructions included with the Administration Set.
It is important to use only
E
-
Z
-
EM, Inc. manufactured high flow tubing with a 0.1 micron
hydrophobic filter to prevent cross contamination of the patient or PROTOCO
2
L™Colon
Insufflator. E
-
Z
-
EM, Inc. manufactures an Administration Set (that includes the filter) designed
to provide optimum insufflator performance. It is recommended that this Administration Set be
used. Always inspect every Administration Set to make su
re there are no signs of damage. If such
a condition exists, do not use the Administration Set. See Administration Set instructions for use.
The use of unauthorized administration sets may cause damage of your insufflator, and result in
voiding your warr
anty.
10.6
ADMINISTRATION SET
CONNECTION FOR INITI
AL
INSUFFLATION
Insert the connector on the Administration Set to the Gas Output connection on the insufflator’s
Front panel.

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
19
10.7
PATIENT INSUFFLATION
1.
Begin insufflation in the lateral decubitus position by p
ressing the FLOW STOP/RUN button
to initiate gas flow. Gently roll the patient into the supine position. Allow the pressure and
volume to stabilize.
2.
Within approximately 1 to 3 minutes, the volume will stabilize between 2 and 3 L, and the
pressure will
stabilize at the set
-
point. If after 3 to 5 minutes, the actual volume stabilizes at
less than 2 Liters, the pressure remains less than the set
-
point, or the volume fails to stabilize,
see OBSERVATIONS DURING INSUFFLATION below.
Note: If the volume reac
hes 4 Liters at any point during the procedure, the flow of CO
2
will
automatically pause. This will be evident by the light on the FLOW STOP/RUN button
going out. Pressing the FLOW STOP/RUN button again will reinitiate the flow for an
additional 2 Liter
s. Each subsequent restarting of the flow will reinstate the flow for an
additional 2 Liters.
3.
Take the scout image. Evaluate the quality of insufflation. If insufflation is insufficient, see
OBSERVATIONS DURING INSUFFLATION below.
4.
Begin supine CT sc
an.
5.
Following the supine scan, roll the patient to the prone position. Immediately take the scout
image.
6.
Begin prone CT scan.
10.8
OBSERVATIONS DURING
INSUFFLATION
1.
Patient Discomfort:
Occasionally, the patient may feel some abdominal
discomfort during the
initial stages of insufflation, which is primarily due to the
distention of the colon. To minimize patient discomfort, the following steps may
be taken:
a.
Instruct the patient to breathe through his/her mouth.
b.
Instruct the patient to relax his/her abdominal
muscles during the
procedure.
c.
If the unit is in RUN mode, the flow of CO
2
may be paused by pressing
the FLOW STOP/RUN button to allow time for the colon to relax. Once
the patient is comfortable, the flow can be re
-
started by pressing the
FLOW STOP/RUN bu
tton again.
d.
For patients who require more gradual insufflation, the pressure of CO
2
may be lowered (15 to 20 mm Hg) by using the Pressure Adjust Dial, to
allow for a more gradual distention of the colon. When the patient is
comfortable, the pressure shoul
d be slowly raised to 20
-
25 mm Hg.