O2 EFFICIENT Operators Manual Model REF 6600 April July 2014

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 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 USE ... 14 9.1 PREPARATION ... 14 9.2 ELECTRICAL CONNECTIONS ... 14 9.3 CO2 HOSE CONNECTIONS ... 15 SECTION 10.0 SETTING-UP FOR THE PROCEDURE ... 17 10.1 POWER ON AND GAS SUPPLY INDICATOR... 17 10.2 PREPARATION TEST ... 17 10.3 TUBING SET CONNECTION ... 18 10.4 SETTING MODE OF OPERATION... 18 10.5 RESET CO2 VOLUME ... 18 10.6 CONNECTION TO ENDOSCOPIC SYSTEM... 18 10.7 SYSTEM SET-UP ... 19 10.8 CO2 VOLUME DISPLAY ... 20 10.9 TERMINATING GAS FLOW & SHUT-DOWN PROCEDURES... 20 SECTION 11.0 DECONTAMINATION, CLEANING AND STORAGE ... 21 11.1 MAINTENANCE CHECKS... 22 11.2 PROFESSIONAL SERVICES AND ORDERING INFORMATION ... 24 11.3 WARRANTY ... 24 11.4 CERTIFICATION OF NON-CONTAMINATION ... 24 SECTION 12.0 CERTIFICATE OF NON-CONTAMINATION ... 25 SECTION 13.0

TROUBLESHOOTING GUIDE ... 26

SECTION 14.0

EMC TABLES... 33

CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual

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Section 1.0 UNPACKING AND GENERAL INSPECTION CAUTION: READ ALL SECTIONS OF THIS MANUAL CAREFULLY BEFORE USING THE CO2EFFICIENT ENDOSCOPIC INSUFFLATOR, SUCH THAT OPERATION IS UNDERSTOOD. IF YOU SHOULD HAVE ANY QUESTIONS, PLEASE CONTACT E-Z-EM, INC. CUSTOMER SERVICE AT 1-800-631-5245 (USA), 1-609-514-2200 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 CO2EFFICIENT ENDOSCOPIC 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: CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual (English Only) Quick Reference Guide Line Cord (mains lead) (see CAUTION below) High Pressure Hose & Yoke Foreign Language Disc Notify Professional Services immediately if any damage or discrepancies are noted. Phone: 1-800-631-5245 (USA), 1-609-514-2200

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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CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual

Section 2.0 INTRODUCTION This manual provides information for the operation of the CO2EFFICIENT ENDOSCOPIC 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

hPa

Hundred Pascal

2.1 INDICATION AND CONTRAINDICATIONS Indications for Use: The CO2EFFICIENT ENDOSCOPIC INSUFFLATOR is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. Contraindications for Use: The CO2EFFICIENT ENDOSCOPIC INSUFFLATOR should be used only for an endoscopic procedure when insufflation of the gastrointestinal tract is necessary to support navigation of the endoscope and perform any evaluation procedures through the endoscope, and should therefore not be used for any other treatments. It should only be used under the direct guidance of a physician experienced in Gastrointestinal Endoscopy procedures. This device is contraindicated for hysteroscopic or laparoscopic insufflation, i.e., it must not be used for intrauterine distension. This device is contraindicated for CT Colonography.

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. An initial pressure relief will occur at 375 mm Hg and a redundant pressure relief will occur at 400 mm Hg. An audible alert will sound when the CO2 gas supply tank pressure is low. An audible alert (a single chirp) will sound when the flow of CO2 is automatically stopped by the device.

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Section 3.0 THEORY OF OPERATION The CO2EFFICIENT ENDOSCOPIC INSUFFLATOR operates by administering CO2 at a maximum flow rate of 3 LPM, and then monitoring the endoscopic pressure. A mode of operation is selected by the operator, by using a switch found on the front panel to select from Free Flow Mode and Managed Flow Mode. It is used to change the rate that the flow is delivered to the endoscopic system. When the switch is set to Free Flow Mode, the unit will deliver CO2 at a flow rate of 3 liters per minute continuous. The clinician will use the air/water valve on the endoscope and visual feedback of the endoscopic system to manually distend the gastrointestinal tract with CO2. When the switch is set to Managed Flow Mode, the system will be delivering CO2 in a more efficient manner. This mode reduces the amount of CO2 that is lost through the air/water valve which is normally lost at a rate of 3 liters per minute. When gas is not used in the endoscopic system to insufflate, the unit will operate at the Managed Flow rate of 0.25 to 1.0 liter per minute. This transition to the Managed Flow rate will occur if the unit senses no need for insufflation in a 2 second time period. When gas is needed to insufflate, the unit will deliver CO2 at a flow rate of 3 liters per minute. The user will need to place the system into RUN mode in order for it to deliver the CO2 to the endoscopic system. The CO2EFFICIENT ENDOSCOPIC INSUFFLATOR has a Pressure Relief Valve set at 375 mm Hg and an independent redundant Pressure Relief Valve pre-set to 400 mm Hg. Both pressure relief safety devices are active whether the FLOW STOP/RUN is on or off.

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CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual

Section 4.0 WARNINGS AND CAUTIONS This section describes warning and caution information for safe operation of the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR. All information in this manual, and particularly in this section, should be read thoroughly and understood before using the device.

4.1 WARNINGS 

Excessive absorption of CO2 results from over insufflation. The GI Tract can be adequately distended by the physician’s modulation of the air/water valve.



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.



Idiosyncratic reactions: In patients with sickle cell disease or pulmonary insufficiency, use of these devices may pose increased risks of respiratory acidosis related to excessive CO2 absorption.



Use only USP “Medical Grade” CO2 available in “D” or “E” supply tanks.



Tubing set is to be changed following standards and guidelines set forth by SGNA and APIC for reprocessing of water bottles used during Gastrointestinal Endoscopy.



Using unauthorized, non-Bracco brand tubing sets will void the warranty. Bracco cannot assume any risk related to the use of non-Bracco brand product.



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 Gastrointestinal Endoscopy. 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 endoscopic system. 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, use only CO2 Endoscopic Tubing Set which includes a ≤0.1 micron hydrophobic filter.



Always instruct the patient to immediately notify the operator of any pain experienced during the procedure. CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual

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

If an emergency should arise whereby the need to terminate the procedure is required, operators should stop the gas flow by turning off the power to the insufflator and promptly disconnecting the CO2 Endoscopic Tubing Set at the unit’s Output Port.



The CO2EFFICIENT ENDOSCOPIC INSUFFLATOR can release CO2 to the surrounding atmosphere in the event of misuse or a fault condition. Use and store the CO2EFFICIENT ENDOSCOPIC 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 CO2EFFICIENT ENDOSCOPIC 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 CO2EFFICIENT ENDOSCOPIC 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 unit 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 (Magnetic Resonance) compatibility, and should not be introduced into the MR scanner room.



Do Not attempt to use this system until you have completed all the steps in “Assembly Prior to Use” 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 Professional Services at 1-800-631-5245 (USA), 1-609-514-2200.

CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual

Section 5.0 DESCRIPTION OF EQUIPMENT The CO2EFFICIENT ENDOSCOPIC INSUFFLATOR is indicated for use as a means to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope under direct observation of a physician.

5.1 SPECIFICATIONS Size:

10” wide x 5.5” high x 10.5” deep. 254 mm x 140 mm x 254 mm

Weight:

Less than 20 lb. (9.0 kg).

Control Panel:

Push-buttons and rocker switch. Digital pressure and volume readouts.

Gas Flow:

0 to 3 LPM.

Operating Pressure:

0 to 350 mm Hg operating.

Pressure Relief Valve:

Relief of pressure at 375 mm Hg A redundant relief of pressure at 400 mm Hg. Both reliefs are active whether gas flow is on or off for added protection.

Operating modes:

Managed Flow, Free Flow, and FLOW STOP/RUN.

Gas Inlet:

“D” or “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.

Tubing Set:

Available for use with ≤0.1 micron hydrophobic filter. E-Z-EM, Inc. supplies a Tubing 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-60601-1; IEC-60601-1-2; 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 hPascal 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 hPascal 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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CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual

Section 6.0 FRONT PANEL CONTROLS

NOTE: The appearance of your CO2EFFICIENT ENDOSCOPIC 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” or “E” CO2 supply tank. [2] VOLUME LITERS DISPLAY Indicates the total amount of gas used since last reset. [3] VOLUME RESET Clears the volume display to zero. [4] FLOW STOP/RUN Depression starts flow and button will illuminate. CO2 will flow in one of two modes set by the switch. The pressure response characteristics at which CO2 is delivered to distend the gastrointestinal tract is a function of the clinician and how this clinician uses CO2 to distend the gastrointestinal tract during a procedure. In Managed Flow Mode, the control system will automatically transition between the high flow rate and low flow rate as required during the procedure to compensate for external variables. To prevent wasting gas in the Free Flow mode, when the FLOW STOP/RUN button is pressed initially and after 150 Liters of CO2 is continuously delivered, the unit automatically returns to STOP mode. An audible alert, in the form of a single chirp, will sound when the unit automatically returns to STOP mode. Thereafter, subsequent presses of the FLOW STOP/RUN button will resume the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual

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delivery of CO2 for an additional 150 Liters before automatically returning to STOP mode. To prevent wasting gas in the Managed Flow mode, when the FLOW STOP/RUN button is pressed initially and no changes in pressure have been detected for 10 minutes, the unit automatically returns to STOP mode. An audible alert, in the form of a single chirp, will sound when the unit automatically returns 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. The user can always depress the FLOW STOP/RUN button during any of these volume increments to stop delivery of CO2.

NOTE: Flow cannot be initiated if gas bottle pressure is less than 25 psi.

[5] FLOW MODE SELECTION SWITCH The unit operates in one of two modes. When the switch is set Free Flow Mode, the unit will deliver CO2 at a flow rate of 3 liters per minute continuous. The clinician will use the air/water valve on the endoscope and visual feedback of the endoscopic system to manually distend the gastrointestinal tract with CO2. When the switch is set to Managed Flow Mode, the system will be delivering CO2 in an more efficient manner. This mode reduces the amount of CO2 that is lost through the air/water valve which is normally lost at a rate of 3 liters per minute. When gas is not used in the endoscopic system to insufflate, the unit will operate at the Managed Flow rate of 0.25 to 1.0 liter per minute. This transition to the Managed Flow rate will occur if the unit senses no need for insufflation in a 2 second time period. When gas is needed to insufflate, the unit will deliver CO2 at a flow rate of 3 liters per minute. [6] GAS OUTPUT CONNECTION TO ENDOSCOPE Connector for Tubing Set. [7] POWER SWITCH Turns the power on and off to the unit.

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CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual

Section 7.0 REAR PANEL CONTROLS

[8] GAS INPUT PORT For connecting a “D” or “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 line cord (mains lead). 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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CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual

Section 9.0 ASSEMBLY PRIOR TO USE 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 CO2EFFICIENT ENDOSCOPIC 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 PREPARATION 1. Install the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR on the Accessory Cart that can be purchased separately, or on a flat surface, away from potential sources of spraying or leaking liquids. 2. Visually inspect the CO2EFFICIENT ENDOSCOPIC 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 line cord (mains lead) to the AC Power Connection on the back of the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR. 3. Before connecting the line cord (mains lead) to the hospital grade wall outlet, make sure that the main power switch is off and that the voltage is correct. The CO2EFFICIENT ENDOSCOPIC 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-ended 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-ended 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 the unit. 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).

NOTE: Do not use any teflon tape or thread sealing compounds on any connection. Figure 9.5 Page 15

CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s 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 CO2EFFICIENT ENDOSCOPIC 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.

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Section 10.0 SETTING-UP FOR 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” or “E” CO2 supply tank to finish a procedure, as indicated below: Lights Green Yellow Red

Available CO2 Gas Tank is Full. Tank is Getting Low. Tank is Low. Change Tank!

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. 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 section 10.1, Power On and Gas Supply Indicator). 3. To prevent wasting gas in the Free Flow mode, when the FLOW STOP/RUN button is pressed initially and after 150 Liters of CO2 is continuously delivered, 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 150 Liters before automatically returning to STOP mode. To prevent wasting gas in the Managed Flow mode, when the FLOW STOP/RUN button is pressed initially and no changes in pressure have been detected for 10 minutes, the unit automatically returns 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. 4. If the unit does not perform properly, do not use. Inspect the unit using the Troubleshooting Guide (Section 13.0) before returning for service.

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CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual

10.3 TUBING SET CONNECTION Insert the connector on the Tubing Set to the Gas Output connection on the unit’s front panel. It is important to use only Bracco manufactured high flow tubing labeled as Bracco CO2 Endoscopic Tubing Set (that includes a ≤0.1 micron hydrophobic filter) designed to provide optimum performance. Always inspect every Tubing Set to make sure there are no signs of damage. If such a condition exists, do not use the Tubing Set. See Tubing Set instructions for use.

10.4 SETTING MODE OF OPERATION To set the mode of operation, use the rocker switch on the front panel to select between Managed Flow and Free Flow.

10.5 RESET CO2 VOLUME Assure that the Volume Liters Display reads zero prior to starting the procedure. To reset the Volume Liters Display, press the Volume Reset button. NOTE: Do not press Volume Reset button once procedure has started.

10.6 CONNECTION TO ENDOSCOPIC SYSTEM The Tubing Set connects into the air/water line of the endoscopic system. Depending on the Endoscope manufacturer there are different connections to the air/water supply line. Each connection has a Luer adaptor and some examples are provided below.

Figure 10.1 CO2 Adaptor for Pentax Endoscope

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Figure 10.2 Example Olympus Water bottle with CO2 Connection MAJ-902

Pentax Medical Group is a Division of Pentax of America, Inc. Olympus America is a Division of Olympus Corporation.

10.7 SYSTEM SET-UP The following operational sequence describes the system set-up for both the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR and Tubing Set:

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i)

Make sure the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR is powered up with no Tubing Set in place.

ii)

Make sure the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR is in STOP mode.

iii)

Use the Flow Mode Selection Switch to set the desired mode for the system.

iv)

As required, zero the volume display using the Volume Reset button.

v)

Remove the Tubing Set from its packaging.

CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual

vi)

Connect Tubing Set Luer fitting to the endoscopic system.

vii)

Connect the Tubing Set fitting to CO2EFFICIENT ENDOSCOPIC INSUFFLATOR.

viii)

Start the endoscopic system by turning on the necessary light and video equipment.

ix)

Verify that the air supply from the endoscopic system is turned off.

x)

Start CO2EFFICIENT ENDOSCOPIC INSUFFLATOR by pressing the FLOW STOP/RUN button.

xi)

Monitor the unit’s volume indicator during procedure

xii)

Stop the unit at conclusion of procedure.

NOTE: If an emergency should arise whereby there is a need to terminate the procedure, the operator should stop the CO2 gas flow by turning off the power to the insufflator and promptly disconnecting the Tubing Set at the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Output port.

10.8 CO2 VOLUME DISPLAY The Digital Volume Display reads the total volume of CO2 passing from the CO2EFFICIENT ENDOSCOPIC 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 999 Liters.

10.9 TERMINATING GAS FLOW & SHUT-DOWN PROCEDURES 1. Upon completion of the diagnostic procedure, press the FLOW STOP/RUN button if in RUN mode. 2. Discard the entire CO2 Endoscopic Tubing Set according to standards and guidelines set forth by SGNA and APIC for reprocessing of water bottles used during Gastrointestinal Endoscopy. 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.

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