PROTOCO2L Operators Manual Model REF 6400 April 2010

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

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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.

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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

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

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

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

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.

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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

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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.

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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.

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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

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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.

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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.

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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. Page 19

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

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