COLON INSUFFLATOR REF 6400 Operator`s

COLON INSUFFLATOR REF 6400 Operator`s
COLON INSUFFLATOR
REF 6400
Operator’s Manual
0086
Rx Only (USA)
TABLE OF CONTENTS
SECTION 1.0
UNPACKING AND GENERAL INSPECTION ………………………………… 3
SECTION 2.0
INTRODUCTION..…………………………………………………………………...4
2.1
INDICATION AND CONTRAINDICATIONS....................................................................... 4
2.2
SAFETY FEATURES ................................................................................................................ 4
SECTION 3.0
INSUFFLATOR THEORY OF OPERATION........................................................ 5
SECTION 4.0
WARNINGS AND CAUTIONS................................................................................. 6
4.1
WARNINGS ................................................................................................................................ 6
4.2
CAUTIONS ................................................................................................................................. 7
SECTION 5.0
DESCRIPTION OF EQUIPMENT........................................................................... 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 AND YOKE ASSEMBLY .......................................... 13
SECTION 9.0
ASSEMBLY PRIOR TO COLON INSUFFLATION ........................................... 14
9.1
INSUFFLATOR PREPARATION.......................................................................................... 14
9.2
ELECTRICAL CONNECTIONS ........................................................................................... 14
9.3
CO2 HOSE CONNECTIONS .................................................................................................. 15
SECTION 10.0 SETTING-UP AND PERFORMING THE PROCEDURE .................................. 17
10.1 POWER ON AND GAS SUPPLY INDICATOR................................................................... 17
10.2 PREPARATION TEST ............................................................................................................ 17
10.3 SETTING PATIENT PRESSURE .......................................................................................... 18
10.4 RESET CO2 VOLUME ............................................................................................................ 18
10.5 PATIENT CONNECTION FOR INSUFFLATION.............................................................. 18
10.6 ADMINISTRATION SET CONNECTION FOR INITIAL INSUFFLATION.................. 18
10.7 PATIENT INSUFFLATION.................................................................................................... 19
10.8 OBSERVATIONS DURING INSUFFLATION .................................................................... 19
10.9 CO2 VOLUME DISPLAY........................................................................................................ 21
10.10 TERMINATING GAS FLOW & SHUT-DOWN PROCEDURES ..................................... 21
SECTION 11.0 DECONTAMINATION, CLEANING 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-CONTAMINATION ................................................... 25
SECTION 14.0
TROUBLESHOOTING GUIDE ............................................................................. 26
SECTION 15.0
EMC TABLES........................................................................................................... 35
PROTOCO2LTM Colon Insufflator User Manual
Page 2
Section 1.0 UNPACKING AND GENERAL INSPECTION
CAUTION: READ ALL SECTIONS OF THIS MANUAL CAREFULLY BEFORE USING
PROTOCO2L™ 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 possible injury to patient or operator.
To avoid inadvertent damage, study this manual thoroughly before handling,
assembling, testing, using, or cleaning the PROTOCO2L™ 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 items listed below:
PROTOCO2L™ 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: 1-800-544-4624 (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 will supply a line cord that is
approved for use in your country.
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PROTOCO2LTM Colon Insufflator User Manual
Section 2.0 INTRODUCTION
This manual provides information for the operation of the PROTOCO2L™ 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 CO2
2.1 INDICATION AND CONTRAINDICATIONS
Indications for Use: The PROTOCO2L™ Colon Insufflator administers and
regulates carbon dioxide as a distention media to the colon during CT Colonography
(CTC or Virtual Colonoscopy) and conventional Colonoscopy.
Contraindications for Use:
The PROTOCO2L™ 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 insufflation.
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.
The 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 pressure relief occurs at 75 mm Hg.
An audible alarm will sound when the CO2 gas supply tank pressure is low.
Additionally, the Gas Supply Indicator bar graph display will flash.
PROTOCO2LTM Colon Insufflator User Manual
Page 4
Section 3.0 INSUFFLATOR THEORY OF OPERATION
The PROTOCO2L™ Colon Insufflator operates by administering CO2 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 gradually increase and will be
displayed on the Pressure Display on the front panel. The flow of CO2 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 CO2 will stop. While in the RUN mode, the PROTOCO2L™ 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 CO2 to flow until the current pressure is equal again to the user
determined colonic pressure setting.
The PROTOCO2L™ 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 safety devices are active whether
the Gas Flow is on or off.
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PROTOCO2LTM Colon Insufflator User Manual
Section 4.0 WARNINGS AND CAUTIONS
This section describes warning and caution information for safe operation of the
PROTOCO2L™ 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 PROTOCO2L insufflator, immediately
discontinue use and provide appropriate medical treatment.

Prior to use, be sure to read all instructions for use on the PROTOCO2L
Administration Set.

Excessive absorption of CO2 results from either excessive flow rate and/or excessive
pressure. The colon can be adequately 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 CO2 gas into open vascular channels. Also,
adequate respiration helps avoid problems related to CO2.

Should accidental intravasion of CO2 occur, in rare circumstances, it can result in
embolization.

Infusion of CO2 can result in carbonic acid irritation to directly contacted tissues.

Use only USP “Medical Grade” CO2 available in “D/E” supply tanks

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 electrical 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 device 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 properly wired
grounding receptacle only.

To prevent unit contamination and patient cross-contamination, use only E-Z-EM’s
PROTOCO2L™ Administration Set which includes a 0.1 micron hydrophobic filter.

Idiosyncratic reactions: In patients with sickle cell disease or pulmonary
insufficiency, use of these devices may pose increased risks of metabolic imbalance
related to excessive CO2 absorption.
PROTOCO2LTM Colon Insufflator User Manual
Page 6

Always instruct the patient to immediately notify the operator of any pain
experienced during the procedure.

If an emergency should arise whereby the need to terminate insufflation is required,
operators should stop the gas flow by promptly disconnecting the PROTOCO2L™
Administration Set at the Insufflator Output Port.

The PROTOCO2L™ Colon Insufflator can release CO2 to the surrounding
atmosphere in the event of misuse or a fault condition. Use and store the
PROTOCO2L™ Colon Insufflator in a well ventilated environment. Additionally,
make sure all CO2 supply tank connections are correctly installed and free of visible
damage. Should an unexplained rapid discharge of CO2 occur, evacuate the
immediate area until it has had sufficient time to ventilate.

High Pressure USP CO2 is supplied to the PROTOCO2L™ Colon Insufflator from
commercially available CO2 supply tanks. Please read and carefully follow all
Warnings, Cautions and Handling Instructions provided with, and listed on these
CO2 supply tanks that are used with the PROTOCO2L™ Colon Insufflator. Failure 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 use 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 device is used in children, elderly and
pregnant women.
4.2 CAUTIONS
Page 7

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 Colon 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 whatso-ever concerning its installation or operation, inform E-Z-EM, Inc. Customer
Solutions at 1-800-544-4624 (USA), 1-516-333-8230.
PROTOCO2LTM Colon Insufflator User Manual
Section 5.0 DESCRIPTION OF EQUIPMENT
The PROTOCO2L™ 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” CO2 supply tank.
WARNING: Do not allow liquid CO2 to enter the unit. This can be prevented by assuring that
the CO2 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 filter.
E-Z-EM, Inc. supplies an Administration Set that
includes this filter.
5.2 ELECTRICAL REQUIREMENTS
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 removable 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.
PROTOCO2LTM Colon Insufflator User Manual
Page 8
5.3 UL EQUIPMENT CLASSIFICATION
Underwriter’s Laboratories/CSA
Class I Type B
5.4 ENVIRONMENTAL REQUIREMENTS
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-condensing
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.
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PROTOCO2LTM Colon Insufflator User Manual
Section 6.0 FRONT PANEL CONTROLS
NOTE: The appearance of your PROTOCO2L™ 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"
CO2 supply 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 delivered 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 procedure, the
unit will remain in run mode until 4 Liters of CO2 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 CO2 for an additional 2 Liters of CO2. 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 CO2 as required by the user.
The user can always depress the STOP/RUN button during any of these volume
increments to stop delivery of CO2.
PROTOCO2LTM Colon Insufflator User Manual
Page 10
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 set 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.
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PROTOCO2LTM Colon Insufflator User Manual
Section 7.0 REAR PANEL CONTROLS
[8] GAS INPUT PORT
For connecting a “D/E” supply tank using the High Pressure Hose and Yoke
assembly provided.
WARNING: Do not allow liquid CO2 to enter the unit. This can be prevented by assuring that
the CO2 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
requirements.
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
that 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.
PROTOCO2LTM Colon Insufflator User Manual
Page 12
Section 8.0 HIGH PRESSURE HOSE AND YOKE ASSEMBLY
The assembly consists of the YOKE as shown in Figure 8.1 and the HIGH
PRESSURE HOSE as shown in Figure 8.2.
Figure 8.1
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
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PROTOCO2LTM Colon Insufflator User Manual
Section 9.0 ASSEMBLY 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 PROTOCO2L™ 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 Sections 9.1, 9.2 and 9.3
9.1 INSUFFLATOR PREPARATION
1. Install the PROTOCO2L™ Colon Insufflator on the Accessory Cart, or on a flat
surface, away from potential sources of spraying or leaking liquids.
2. Visually inspect the PROTOCO2L™ Colon Insufflator for external 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
PROTOCO2L™ Colon Insufflator.
3. Before connecting the power cord to the hospital grade wall outlet, make sure
that the main power switch is off and that the voltage is correct. The
PROTOCO2L™ Colon Insufflator has a universal AC line input device, the
nominal AC line voltage is 100 to 240 VAC and the AC line frequency 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.
PROTOCO2LTM Colon Insufflator User Manual
Page 14
9.3 CO2 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 CO2 supply
tank (Tank not provided with system), as shown in Figure 9.2.
Figure 9.1
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 CO2 supply
tank post valve. Insert the pins 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
Figure 9.3
Figure 9.4
3. Remove cap from the CO2 Input port on back of Insufflator. Tighten the other
end of the High-Pressure Hose to the CO2 Input port on the back of the Unit
using a 9/16″ open-ended wrench (see Figure 9.5).
Figure 9.5
Page 15
NOTE: Do not use any teflon tape or
thread sealing compounds on any
connection.
PROTOCO2LTM Colon Insufflator User Manual
WARNING: Do not allow liquid CO2 to enter the unit. This can be prevented by assuring that
the CO2 supply tank is maintained in a vertical upright position at all times.
USE ONLY MEDICAL GRADE CO2 SIZE “D” OR “E” supply tanks.
Before each use the following procedures or inspections should be performed:
Visually inspect the PROTOCO2L™ 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.
Inspect the connection to the CO2 supply tank, to assure it is intact and tight.
NOTE: To assure maximum life of CO2 supply tank, always close CO2 tank from the
post valve when not in use.
PROTOCO2LTM Colon Insufflator User Manual
Page 16
Section 10.0 SETTING-UP AND PERFORMING THE
PROCEDURE
10.1 POWER ON AND GAS SUPPLY INDICATOR
1. Open the valve on the CO2 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
coding in the bar graph is a guide to determine whether there is sufficient gas in
a “D/E” CO2 supply tank to finish a procedure, as indicated below:
Lights
Green
Yellow
Red
Available CO2 Gas
Tank Pressure is greater than 175 PSI.
Tank Pressure is 75 to 175 PSI.
Tank Pressure is less than 75 PSI. Change Tank!
NOTE: If CO2 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 Display
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
CO2 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 dial 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 CO2 are
delivered and the unit automatically returns to STOP mode. Thereafter,
subsequent presses of the FLOW STOP/RUN button will resume the delivery of
CO2 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 illuminated 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.
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PROTOCO2LTM Colon Insufflator User Manual
10.3 SETTING PATIENT PRESSURE
To set patient pressure, rotate the Pressure Select 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 Hg during the procedure to obtain adequate
distention.
10.4 RESET CO2 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 procedure 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 PROTOCO2L™ 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 sure 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 warranty.
10.6 ADMINISTRATION SET CONNECTION FOR INITIAL
INSUFFLATION
Insert the connector on the Administration Set to the Gas Output connection on the insufflator’s
Front panel.
PROTOCO2LTM Colon Insufflator User Manual
Page 18
10.7 PATIENT INSUFFLATION
1.
Begin insufflation in the lateral decubitus position by pressing 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 reaches 4 Liters at any point during the procedure, the flow of CO2 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 Liters. 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 scan.
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 CO2 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 button again.
d. For patients who require more gradual insufflation, the pressure of CO2
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 should be slowly raised to 20-25 mm Hg.
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PROTOCO2LTM Colon Insufflator User Manual
2. Insufficient Distention: It is not uncommon for some colonic segments to
appear inadequately distended in either the prone or supine positions. In
particular, inadequate distention of the transverse colon may occur in heavier
patients in the prone position. To improve distention:
a. Check to make sure that the flow of CO2 has not paused (i.e. that the
FLOW STOP/RUN button is illuminated).
b. Check the Administration Set tubing for kinks, closed clamps, excessive
colonic fluid, or anything that could block the flow of CO2 into the
patient.
c. Remind the patient to breathe orally.
d. Instruct the patient to relax his/her abdominal muscles.
e. It may be necessary, particularly for the heavier patient, to use pillows or
foam positioning blocks underneath a patient’s sternum and/or pelvis to
improve colonic distention while in the prone position. By elevating
these portions of a patient’s anatomy, the abdominal cavity should
distend more freely and redistribute the patient’s weight on the CT table.
f.
If necessary, additional CO2 (up to 2 Liters) may be added by pressing
the FLOW STOP/RUN button.
3. Lower than expected volume of CO2 : A stabilized volume of less than 2 Liters
of CO2 in the initial scanning position is generally an indication of incomplete
distention of one or more colonic segments. If this occurs, perform the following
steps:
a. Roll the patient onto either side to redistribute the CO2 in the colon.
b. Raise the pressure to 25 mm Hg.
c. A drop in the pressure as indicated on the pressure display on the front
panel will indicate the opening of the segment in question, and will be
accompanied by an increase in the volume of CO2.
d. Continue with the rolling maneuver until the volume reaches at least 2
Liters.
4. Higher than expected volume of CO2: If the volume pauses at 4 Liters, one of
the following conditions may be present. A scout image should be taken
immediately to evaluate.
a. Pneumoperitoneum – If free intra-peritoneal air is observed, or if
colonic perforation is suspected, immediately discontinue insufflation by
disconnecting the administration set from the insufflator. Provide
appropriate medical attention.
b. Small bowel reflux – If reflux is evident and distention is acceptable,
proceed with study. If additional CO2 is required, it may be added by
depressing the FLOW STOP/RUN button, under the supervision of a
physician. If small bowel reflux is observed, completing the study as
quickly as possible will help to minimize the reflux.
c. Leakage around rectal tube – If the colon is not fully distended, and no
small bowel reflux is evident, it may be due to leakage around the rectal
tube. If not already inflated, the physician should consider inflating the
rectal balloon on the rectal tube. In addition, ask the patient to squeeze
his/her muscles to retain the rectal tube. If additional CO2 is required, it
may be added by depressing the FLOW STOP/RUN button.
PROTOCO2LTM Colon Insufflator User Manual
Page 20
NOTE: If an emergency should arise whereby there is a need to terminate
insufflation, the operator should stop the CO2 gas flow by promptly disconnecting
the Administration Set at the PROTOCO2L™ Colon Insufflator Output port.
10.9 CO2 VOLUME DISPLAY
The Digital Volume Display reads the total volume of CO2 passing from the
PROTOCO2L™ Colon Insufflator to the patient. The digital display indicates the
volume of CO2 delivered in Liters and tenths of Liters and has a range of 0 to 99.9
Liters.
NOTE: While in the RUN mode, the unit will maintain the set pressure in the colon
even if there is no apparent flow. The unit must be left on until the procedure is
completed.
10.10 TERMINATING GAS FLOW & SHUT-DOWN PROCEDURES
1. Upon completion of the diagnostic procedure, disconnect PROTOCO2L™
Administration Set from the unit at the Output port and press the FLOW
STOP/RUN button if in RUN mode. Allow colon to deflate through the
PROTOCO2L™ Administration Set.
2. Deflate retention cuff, clamp administration set to prevent spillage of colonic
fluids and remove tip. Discard the entire PROTOCO2L™ Administration Set in
accordance with all Federal, State and Local regulations. Administration Sets
are intended for single-use only. Reuse of the administration set carries an
increased risk of cross-contamination.
3. Turn power off and disconnect the power cord from power outlet.
4. It is recommended that the CO2 supply tank valve be fully closed when not in
use.
Page 21
PROTOCO2LTM Colon Insufflator User Manual
Section 11.0 DECONTAMINATION, CLEANING AND STORAGE
Prior to disinfecting the PROTOCO2L™ Colon Insufflator, ensure the power is
turned off and the electrical cord is unplugged. To disinfect the PROTOCO2L™
Colon Insufflator wipe down with an intermediate-level disinfectant (corrosive
disinfectants, such as bleach, are not recommended since they may damage the
equipment) in accordance with the manufacturer’s directions. Do not use abrasive or
sharp-edged devices when disinfecting the PROTOCO2L™ Colon Insufflator. Do
not allow fluids to enter the unit. Dry all components thoroughly. Do not sterilize or
autoclave this unit.
For general cleaning, the PROTOCO2L™ Colon Insufflator can be wiped down with
a damp cloth and mild soap.
The E-Z-EM, Inc. PROTOCO2L™ Colon Insufflator should be covered and stored in
a cool dry location. Care should be taken to avoid rough handling, jarring, or
dropping the unit.
PROTOCO2LTM Colon Insufflator User Manual
Page 22
Section 12.0 REPAIR
There are no user adjustments inside the PROTOCO2L™ Colon Insufflator cabinet.
Repairs and adjustments are to be performed only by E-Z-EM, Inc. or authorized
service or repair facilities. Unauthorized service, repair, or modifications to the
PROTOCO2L™ Colon Insufflator will void your warranty.
As with any precision instrument, periodic calibration of the unit on an annual basis
is recommended, or on a more frequent basis if conditions require.
*If repairs become necessary call E-Z-EM, Inc. prior to returning the device, and
request return authorization.
Warranty repairs will be made without charge. All other repairs will be made on a
time and material basis. If requested, E-Z-EM, Inc. will provide an estimate of the
repair cost and the time for the repair before any work is done. For customers within
the US, repair items, (including power cord, Yoke and High Pressure Hose) should
be carefully repackaged and returned, post paid, to:
E-Z-EM, Inc.
Suite 126
532 Broadhollow Road
Melville, NY 11747
For customers outside of the US, please call Customer Service for instructions on
returning your unit for service.
*PRODUCTS MAY NOT BE RETURNED TO E-Z-EM, INC. WITHOUT
PRE-APPROVAL.
12.1 CUSTOMER SOLUTIONS AND ORDERING INFORMATION
Phone: 1-800-544-4624 (USA), 1-516-333-8230
12.2 WARRANTY
Your new PROTOCO2L Colon Insufflator is warrantied against all defects in
materials and workmanship for 12 months from the date of purchase.
This warranty shall not apply to any PROTOCO2L Colon Insufflator which:
Page 23

Has been repaired by anyone other than an authorized E-Z-EM, Inc.
representative

Has been altered in any way so as to, in the judgment of E-Z-EM, Inc. affect
its function.

Has been subject to misuse, negligence, or accident, including damage
caused by contact with patient effluent or other substances.
PROTOCO2LTM Colon Insufflator User Manual
This warranty does not cover routine cosmetic wear and tear on the system,
including scratching and marring of this device.
This warranty is in lieu of all other warranties, expressed or implied, including
without limitation any implied warranty of merchantability or fitness for a particular
use, and of all other obligations or liabilities on the part of E-Z-EM, Inc. There are
no warranties that extend beyond the description on the face hereof.
12.3 CERTIFICATION OF NON-CONTAMINATION

All products being returned to E-Z-EM, Inc. must be accompanied by a Certificate of
Non-Contamination.

Products that have become contaminated in any way shall not be returned to
E-Z-EM, Inc., unless special written permission has been granted by E-Z-EM, Inc.
Otherwise, a Certificate of Non-Contamination shall be provided with returned
products that have been reportedly decontaminated.

In other special cases certification of Proper Handling for Bio-Hazardous Material
must be sent to E-Z-EM, Inc. for pre-approval before such material can be returned.
PROTOCO2LTM Colon Insufflator User Manual
Page 24
Section 13.0 CERTIFICATE OF NON-CONTAMINATION
Customer Name:
Address:
City:
State:
Zip Code:
Contact Name:
Authorized Signature:
Telephone # and E-mail:
Product Model No.:
Description:
SERIAL No.:
RA. No.:
The above person hereby certifies that the above described product being returned to E-Z-EM, Inc., has
been inspected and contains no foreign material or fluids and is not contaminated with any bio-hazardous
matter or any other material that may cause or contribute to any illness or personal injury of any kind.
Prior to disinfecting the PROTOCO2L™ Colon Insufflator, ensure the power is turned off and the
electrical cord is unplugged. To disinfect the PROTOCO2L™ Colon Insufflator wipe down with an
intermediate-level disinfectant (corrosive disinfectants, such as bleach, are not recommended since they
may damage the equipment) in accordance with the manufacturer’s directions. Do not use abrasive or
sharp-edged devices when disinfecting the PROTOCO2L™ Colon Insufflator. Do not allow fluids to
enter the unit. Dry all components thoroughly. Do not sterilize or autoclave this unit.
Prior to returning any product to E-Z-EM, Inc. complete this Certificate of Non-Contamination Form, and
send/fax to E-Z-EM, Inc. Quality department at 1-631-847-3904
Page 25
PROTOCO2LTM Colon Insufflator User Manual
Section 14.0 TROUBLESHOOTING GUIDE
Make sure that you have read and understand the prior sections of this operator’s manual that provide
normal operating instructions for your PROTOCO2L™ Colon Insufflator, including the warnings and
cautions section. Before making arrangements with E-Z-EM, Inc. Customer Solutions to send your
PROTOCO2L™ Colon Insufflator unit back to the factory for service, we ask that you take a few minutes
to review the following information in this guide while simultaneously examining your unit.
Please be advised that the appearance of your PROTOCO2L™ Colon Insufflator may differ slightly from
the units shown in the following photographs. (Example: buttons may be round or square).
The Field Checkout steps listed here pertain to common operating conditions and possible malfunctions.
Review this information and refer to it when communicating with your E-Z-EM, Inc. Customer Solutions
Representative. This will enable us to identify the best course of action to meet your service needs.
Should you need further assistance with this guide, see your supervisor, or contact E-Z-EM, Inc.,
Customer Solutions at 1-800-544-4624 (USA), 1-516-333-8230.
Condition
Possible Causes
Field Checkout
My PROTOCO2L™ Colon
Insufflator does not
Power-up at all.
No power at wall outlet
Check PROTOCO2L™ Colon Insufflator in wall outlet known
to be operational.
What should I do?
Blown fuse
Remove power cord from rear panel of PROTOCO2L™
Colon Insufflator and use a small screwdriver to open fuse
holder.
Pull fuse holder down and examine fuses.
If blown, replace with 0.5-Amp 250-Volt Time-Delay Fuses.
PROTOCO2LTM Colon Insufflator User Manual
Page 26
Condition
Possible Causes
Field Checkout
My PROTOCO2L™ Colon
Insufflator does not Powerup at all.
Front panel rocker switch
“off”
With unit plugged into wall outlet, activate Power Switch to
the ON or (1) position.
What should I do?
Upon completing its Power-up sequence, the front panel
should appear as follows:
Power Switch
The power switch should be illuminated with the VOLUME
LITERS and PRESSURE displays both Indicating “0”.
Additionally, the GAS SUPPLY Indicator should also be
illuminated and indicate the current amount of CO2 in the
supply tank. The above display indicates that the unit has
correctly Powered-up.
Should the unit continue to fail to Power-up, or if the front
panel does not appear as shown above after Power-up, you
will need to contact E-Z-EM, Inc. Customer Solutions.
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PROTOCO2LTM Colon Insufflator User Manual
Condition
Possible Causes
Field Checkout
My PROTOCO2L™ Colon
Insufflator does not deliver
CO2.
Empty CO2 supply tank or
valve closed
After successfully Powering-up your PROTOCO2L™ Colon
Insufflator, examine the GAS SUPPLY Indicator on the front
panel.
What could be the problem?
Make sure that the tank Valve for the CO2 supply tank is
open. Your PROTOCO2L™ Colon Insufflator should sense
the pressure from the CO2 supply tank and the GAS
SUPPLY Indicator should illuminate as follows: 3 red, 4
yellow and 3 green.
If during Power-up or operation of the PROTOCO2L™
Colon Insufflator, the CO2 in the supply tank is depleted, the
illuminated GAS SUPPLY Indicator segments extinguish
themselves from the full reading. Once the GAS SUPPLY
Indicator shows 3 red segments, the unit will periodically
beep and no longer deliver CO2. Additionally the 3 red
segments will also blink.
If this occurs, reconnect the PROTOCO2L™ Colon
Insufflator to a full CO2 supply tank to continue operation.
Should the PROTOCO2L™ Colon Insufflator’s CO2 Supply
display fail to indicate full after verifying the CO2 supply
tank is full and the tank valve is open, you will need to
contact E-Z-EM, Inc. Customer Solutions.
PROTOCO2LTM Colon Insufflator User Manual
Page 28
Condition
Possible Causes
Field Checkout
My PROTOCO2L™ Colon
Insufflator does not deliver
CO2.
PROTOCO2L™ Colon
Insufflator flow rate
incorrect
To check the PROTOCO2L™ Colon Insufflator’s ability to
deliver CO2 to the patient, follow these verification steps:
What could be the problem?
After Powering-up and making sure that your
PROTOCO2L™ Colon Insufflator is connected to the CO2
supply tank, depress the VOLUME RESET button, zero will
appear in the VOLUME LITERS display.
Rotate the Pressure Adjustment Dial to 25 mm Hg.
Disconnect the Administration Set if connected.
Press the FLOW STOP/RUN button to start.
Using a wrist watch with a second hand or a stop watch,
allow the unit to deliver 4.0 liters of CO2. The unit should
reach this volume and automatically return to stop between
90 and 120 seconds. During this time interval, place your
finger near the Gas OUTPUT. You should feel gentle pulses
of CO2 exiting from the PROTOCO2L™ Colon Insufflator.
Page 29
PROTOCO2LTM Colon Insufflator User Manual
Condition
Possible Causes
Field Checkout
“CONTINUED”
My PROTOCO2L™ Colon
Insufflator does not deliver
CO2.
PROTOCO2L™ Colon
Insufflator flow rate
incorrect
What could be the problem?
At start-up, your PROTOCO2L™ Colon Insufflator should
normally deliver the flow of CO2 to the patient incrementally
as follows: 1 LPM for 0 to 0.5 Liters of delivered volume, 2
LPM for greater than 0.5 to 1 Liter of delivered volume and
a maximum of 3 LPM for delivered volumes greater than 1
Liter. This procedure verifies this performance parameter. If
you are unable to successfully replicate these steps, contact
E-Z-EM, Inc. Customer Solutions or check the routing of
patient Administration Set to make sure that it is not kinked,
occluded or leaking.
PROTOCO2LTM Colon Insufflator User Manual
Page 30
Condition
Possible Causes
Field Checkout
My PROTOCO2L™ Colon
Insufflator is not distending
the colon enough.
PROTOCO2L™ Colon
Insufflator delivery pressure
incorrect.
To Check the PROTOCO2L™ Colon Insufflator’s ability to
deliver CO2 at a set pressure please follow these verification
steps:
What could be the problem?
Attach an Administration Set to the Gas OUTPUT of your
PROTOCO2L™ Colon Insufflator. Engage the tubing clamp
at the distal end of the Administration Set.
Using the Pressure Adjustment Dial, set the delivery pressure
to 25 mm Hg.
Press the FLOW STOP/RUN button to start the delivery of
CO2. As the flow of CO2 starts, the Effluent Trap belonging
to the Administration Set should start to inflate. Additionally,
the PRESSURE Display should start to increase.
Once the Effluent Trap is full, the PRESSURE displayed
by the PROTOCO2L™ Colon Insufflator should reach
approximately 35 to 45 mm Hg.
Page 31
PROTOCO2LTM Colon Insufflator User Manual
Condition
Possible Causes
Field Checkout
PROTOCO2L™ Colon
Insufflator delivery pressure
incorrect.
With the pressure holding steady between 35 to 45 mm Hg,
place the inflated Effluent Trap in your hand as shown.
While in this position, use your thumb to gently squeeze it
flat.
“CONTINUED”
My PROTOCO2L™ Colon
Insufflator is not distending
the colon enough.
What could be the problem?
As the Effluent Trap is squeezed, the pressure on the display
will rise. Maintain a uniform pressure on the Effluent Trap
such that the pressure displayed remains between 55 and 65
mm Hg for 5 seconds. At the end of the 5 second time, an
audible click should be heard from the unit and the CO2 in
the Effluent Trap should freely vent from the system. During
venting, the PRESSURE display should blink and the unit
should beep.
Remove finger pressure from the Effluent Trap. Verify
reinflation to 35 to 45 mm Hg.
Your PROTOCO2L™ Colon Insufflator should also vent in
accordance with the checkout steps prescribed above. If you
are unable to replicate unit operation as prescribed here
contact E-Z-EM, Inc. Customer Solutions.
Depending upon the particular patient and clinical set-up, it
may be necessary to use pillows or foam positioning blocks
underneath a patient’s sternum and/or pelvis to improve
colonic distention while in the prone position. By elevating
these portions of a patient’s anatomy, the abdominal cavity
should distend more freely and redistribute the patient’s
weight on the CT table.
PROTOCO2LTM Colon Insufflator User Manual
Page 32
Condition
Possible Causes
Field Checkout
My CO2 supply Tank is
prematurely emptying.
Valve on CO2 supply tank
left open all of the time.
We recommend attaching your PROTOCO2L™ Colon
Insufflator accessory to either “D” or “E” size CO2 supply
tank. Be sure to close the CO2 supply tank valve whenever
the unit is not in use.
What could be the problem?
The pneumatic design of the PROTOCO2L™ Colon
Insufflator is not intended to provide a full time gas seal from
the CO2 supply tank while the device is not being used or in
storage. Should the CO2 supply tank valve inadvertently be
left open, there is a high likelihood that the CO2 supply tank
contents will gradually empty over several days.
High Pressure Hose from
CO2 supply tank is not
installed properly
If after opening and closing the CO2 supply tank valve with
your procedure schedule, you still encounter problems with
CO2 supply tank prematurely emptying, there is the
possibility that the High Pressure Hose from the CO2 supply
tank to the PROTOCO2L™ Colon Insufflator unit is leaking.
Please inspect the High Pressure Hose in accordance with the
following procedure: Using an adjustable or Open Ended ¾"
wrench, detach the High Pressure Hose from
PROTOCO2L™ Colon Insufflator’s rear panel. Inspect the
tapered surface of the free standing nipple on the
PROTOCO2L™ Colon Insufflator and the interior of the
High Pressure Hose. This is the sealing surface. Verify that it
is free of any debris or contaminant. Also, verify that the
surface is smooth and free of any nicks or distortion.
Taper
Taper
Repeat this inspection procedure at the identical tapered gas
connection at the CO2 supply tank valve Yoke.
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PROTOCO2LTM Colon Insufflator User Manual
Condition
Possible Causes
Field Checkout
High Pressure Hose from
CO2 supply tank is not
installed properly
Inspect the CO2 supply tank Yoke and verify that the plastic
disc that creates the gas seal at the CO2 supply tank valve is
in-place and free from defect.
“CONTINUED”
My CO2 supply Tank is
prematurely emptying.
What could be the problem?
Disc
After verifying all High Pressure Hose sealing surfaces are
clean and free of defect; reconnect the High Pressure Hose to
the CO2 supply tank Yoke and PROTOCO2L™ Colon
Insufflator. Use an adjustable or Opened Ended ¾" wrench
to tighten securely. DO NOT USE ANY TEFLON TAPE
OR THREAD SEALING COMPOUNDS.
Reconnect the Yoke to the CO2 supply tank valve making
sure that the plastic sealing disk is in place.
Open the CO2 supply tank valve. If CO2 continues to
prematurely empty or should you hear CO2 escaping from
any of these connections or the High Pressure Hose itself,
contact E-Z-EM, Inc. Customer Solutions.
PROTOCO2LTM Colon Insufflator User Manual
Page 34
Section 15.0 EMC TABLES
The PROTOCO2L™ Colon Insufflator has been tested by Underwriters Laboratory to the
following electro-magnetic compatibility standards:
Table 1
Guidance and manufacturer’s declaration – electromagnetic emissions
The PROTOCO2L Colon Insufflator is intended for use in the electromagnetic environment specified below. The
customer or the user of the PROTOCO 2L Colon Insufflator should assure that it is used in such an environment.
Emissions Test
Compliance
CISPR 11
RF Emissions
Group 1
CISPR 11
RF Emissions
Class A
IEC 61000-3-2
Harmonic Emissions
Class A
IEC 61000-3-3
Voltage fluctuations /
flicker emissions
Page 35
Electromagnetic environment - guidance
The Colon Insufflator uses RF energy only for its
internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in
nearby electronic equipment.
Complies
PROTOCO2LTM Colon Insufflator User Manual
Table 2
Guidance and manufacturer’s declaration – electromagnetic immunity
The PROTOCO2L Colon Insufflator is intended for use in the electromagnetic environment specified below.
The customer or the user of the PROTOCO2L Colon Insufflator should assure that it is used in such an
environment.
IEC 60601
test level
Immunity Test
IEC 61000-4-2
Electrostatic
discharge (ESD)
IEC 61000-4-4
Electrical fast
transient burst
IEC 61000-4-5
Surge
IEC 61000-4-11
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-8
Power frequency
(50/60 Hz)
magnetic field
Compliance level
Electromagnetic environment –
guidance
+/-6 KV contact
+/-6 KV contact
+/-8 KV air
+/-8 KV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
+/-2 KV for power
supply lines
+/-2 KV for power
supply lines
Mains power quality should be that of a
typical commercial or hospital
environment.
+/-1 KV for
input/output
lines
+/-1 KV for
input/output
lines
+/-1 KV differential
mode
+/-1 KV differential
mode
+/-2 KV common
mode
+/-2 KV common
mode
<5 % Ut
(>95 % dip in Ut)
for 0.5 cycle
<5 % Ut
(>95 % dip in Ut)
for 0.5 cycle
40 % Ut
(60 % dip in Ut)
for 5 cycles
40 % Ut
(60 % dip in Ut)
for 5 cycles
70 % Ut
(30% dip in Ut)
for 25 cycles
70 % Ut
(30% dip in Ut)
for 25 cycles
<5 % Ut
(>95 % dip in Ut)
for 5 sec
<5 % Ut
(>95 % dip in Ut)
for 5 sec
3 A/m
3 A/m
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the
PROTOCO2L Colon Insufflator requires
continued operation during power mains
interruptions, it is recommended that the
PROTOCO2L Colon Insufflator be
powered from an uninterruptible power
supply or battery.
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or hospital
environment.
Note: Ut is the A.C. mains voltage prior to application of the test level.
PROTOCO2LTM Colon Insufflator User Manual
Page 36
Table 3
Guidance and manufacturer’s declaration – electromagnetic immunity
The PROTOCO2L Colon Insufflator is intended for use in the electromagnetic environment specified below. The
customer or the user of the PROTOCO 2L Colon Insufflator should assure that it is used in such an environment.
IEC 60601 test
Compliance
Immunity Test
level
level
Electromagnetic environment –guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the
PROTOCO2L Colon Insufflator, including cables, than
the recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
IEC 61000-4-6
Conducted RF
IEC 61000-4-3
Radiated RF
3 Vrms
150 kHz to 80 MHz
3 Vrms
d = 1,2  P
3 V/m
80 MHz to 2.5 GHz
3 V/m
d = 1,2  P
d = 2,3  P
80 MHz to 800 MHz
800 MHz to 2.5 GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
a
determined by an electromagnetic site survey , should
be less than the compliance level in each frequency
b
range .
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
PROTOCO2L Colon Insufflator is used exceeds the applicable RF compliance level above, the PROTOCO 2L
Colon Insufflator should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the PROTOCO2L Colon Insufflator.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m
Page 37
PROTOCO2LTM Colon Insufflator User Manual
Table 4
Recommended separation distances between Portable and mobile RF communications
equipment and the PROTOCO2L
The PROTOCO2L Colon Insufflator is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the PROTOCO 2L Colon Insufflator
can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the PROTOCO 2L Colon Insufflator as
recommended below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
m
Read maximum output
power of transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5 GHz
W
d = 1,2  P
d = 1,2  P
d = 2,3  P
0,01
0,12
0,12
0,23
0,1
0,38
0,38
0,73
1
1,2
1,2
2,3
10
3,8
3,8
7,3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
PROTOCO2LTM Colon Insufflator User Manual
Page 38
Manufactured for E-Z-EM, Inc.
a subsidiary of Bracco Diagnostics Inc.
107 College Road East
Princeton, NJ 08540
Phone: 1-(800) 544-4624 (USA), 1-(516) 333-8230
Bracco UK Ltd.
Wooburn Green, Bucks, HP10 0HH, UK
+44 (0) 1628 851500 (UK)
Distributed in Canada by:
E-Z-EM Canada Inc.
Anjou, Quebec H1J 2Z4, Canada
00731G REV. 04/10
©Copyright 2006 E-Z-EM, Inc All Rights Reserved
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