COLON INSUFFLATOR REF 6400 Operator`s
Contents
1. 24 SECTION 13 0 CERTIFICATE OF NON CONTAMINATIONN 25 SECTION 14 0 TROUBLESHOOTING GUIDIE 26 SECTION 15 0 EMC TABLES 00 iia AI AAA Ra 35 PROTOCOL Colon Insufflator User Manual Page 2 section 1 0 UNPACKING AND GENERAL INSPECTION CAUTION READ ALL SECTIONS OF THIS MANUAL CAREFULLY BEFORE USING PROTOCO L COLON INSUFFLATOR SUCH THAT OPERATION IS UNDERSTOOD IF YOU SHOULD HAVE ANY QUESTIONS PLEASE CONTACT E Z EM INC CUSTOMER SOLUTIONS AT 1 800 544 4624 516 333 8230 OR YOUR LOCAL E Z EM INC REPRESENTATIVE Proper care and maintenance are critical for safe operation of sophisticated medical equipment We recommend careful inspection of all equipment upon receipt and prior to each use as a safeguard against possible injury to patient or operator To avoid inadvertent damage study this manual thoroughly before handling assembling testing using or cleaning the PROTOCO L Colon Insufflator Examine the shipping carton and instrument for signs of damage Any breakage or other apparent damage should be noted the evidence retained and the carrier or shipping agency notified Verify that the shipping carton contains the items listed below PROTOCO L Colon Insufflator Operator s Manual Quick Reference Guide Power Cord see CAUTION below High Pressure Ho2. 13 SECTION 9 0 ASSEMBLY PRIOR TO COLON INSUFFLATION 14 9 1 INSUFFLATOR PREPARATION iii e goes aou mes aa v s Qu aide cias 14 9 2 ELECTRICAL CONNECTIONS aint sion eseye esaye u SSS 14 9 3 CO HOSE CONNECTION Saa 15 SECTION 10 0 SETTING UP AND PERFORMING THE PROCEDURE 17 10 1 POWER ON AND GAS SUPPLY INDICATONR 17 10 2 PREPARATION TEST ontario ROSITA 17 10 3 SETTING PATIENT PRESSURE a u u u a Ee 18 10 4 RESET COs VOLUME u ects sissorpaccnstongedestecsencsneansapedescdvcesecsecsuansecadeseuesesevesecedesedsseas 18 10 5 PATIENT CONNECTION FOR INSUFFLATIOLNN 18 10 6 ADMINISTRATION SET CONNECTION FOR INITIAL INSUFFLATION 18 10 7 PATIENT INSUFELATION iii u m m SSS u uu uY 19 10 8 OBSERVATIONS DURING INSUFFLATIONN 19 10 9 COs VOEUME DISPLAY i uu nuan ham AIR 21 10 10 TERMINATING GAS FLOW SHUT DOWN PROCEDURES 21 SECTION 11 0 DECONTAMINATION CLEANING AND STORAGE 22 SECTION 12 0 REPAIR oia ia 23 12 1 CUSTOMER SOLUTIONS AND ORDERING INFORMATION 23 12 2 WARRANTY curarlo 23 12 3 CERTIFICATION OF NON CONTAMINATIONN
3. The PROTOCO L 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 PROTOCOL Colon Insufflator is intended for use in the electromagnetic environment specified below The customer or the user of the PROTOCOL Colon Insufflator should assure that it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance CISPR 11 RF Emissions 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 co ven ann RF Emissions Class A Me lami n Harmonic Emissions Class A IEC 61000 3 3 Voltage fluctuations Complies flicker emissions Page 35 PROTOCO L Colon Insufflator User Manual Table 2 Guidance and manufacturer s declaration electromagnetic immunity The PROTOCO L Colon Insufflator is intended for use in the electromagnetic environment specified below The customer or the user of the PROTOCO L Colon Insufflator should assure that it is used in such an environment IEC 60601 Electromagnetic environment Immunity Test test level Compliance level guidance 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
4. COLON INSUFFLATOR 6400 Operator s Manual a s PROTOCOL COLON INSUFFLATOR VOLUME LITERS FLOW STOP RUN PRESSURE mmHg i Tita GAS SUPPLY VOLUME RESET 10 15 wily AN SAL e MA Ox saw co sm rE a ees gt a gt C 0086 Rx Only USA DEHP TABLE OF CONTENTS SECTION 1 0 UNPACKING AND GENERAL INSPECTION 3 SECTION2 0 INTRODUC TION 2221 A a ala lat lk aaa a opa ke 4 2 1 INDICATION AND CONTRAINDICATION S 4 2 2 SAFETY FEATURES sirige aiea osaa daea aeh auae 4 SECTION 3 0 INSUFFLATOR THEORY OF OPERATIONN 5 SECTION 4 0 WARNINGS ANDCAUTION Srs 6 4 1 MEDIO u nu SS DS u uu us 6 4 2 CAUTIONS E E E E E E T E E EE 7 SECTION 5 0 DESCRIPTION OF EQUIPNENT a u u n n u Q u Q Q a abu a 8 5 1 SPE CIFICA LION Soria a ad ias 8 5 2 ELECTRICAL REQUIREMENTS sarrianet recordara cnica 8 5 3 UL EQUIPNIENTCHLASSIPICATIONu u u L iii 9 5 4 ENVIRONMENTAL REQUIREMENTS 9 SECTION 6 0 FRONT PANEL CONTROTLS 5 iii eis yaskoosnossssodakvesosnosesasvkeos bvosessouaskssssans nsvsasoou ke 10 SECTION 7 0 REAR PANEL CONTROLS uuu yibeavasotenasssenaoiasdakpa oasansesaooysasesestonssassssoueosassouse 12 SECTION 8 0 HIGH PRESSURE HOSE AND YOKE ASSEMBLY
5. If not already connected assemble the High Pressure Hose and Yoke using a 9 16 open end wrench on the hose fitting and a Open Ended wrench on the Yoke s hexagonal shaped surface The complete Hose Yoke assembly is shown in Figure 9 1 Identify the post valve Yoke positioning holes on the CO supply tank Tank not provided with system as shown in Figure 9 2 Figure 9 1 o Figure 9 2 2 Slide the Hose Yoke assembly over the top of the post valve and align the two positioning pins from the Yoke with the two locating holes from the CO 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 CO Input port on back of Insufflator Tighten the other Page 15 end of the High Pressure Hose to the CO 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 PROTOCO L Colon Insufflator User Manual WARNING Do not allow liquid CO to enter the unit This can be prevented by assuring that the CO supply tank is maintained in a vertical upright position at all times USE ONLY MEDICAL GRADE CO SIZE D OR E supply tan
6. TPUT VOLUME RESET m OUTPU m Q ci vi o 25 NOTE The appearance of your PROTOCO L Colon Insufflator may differ slightly from the units shown in the illustrations and photographs Example buttons may be round or square 1 GAS SUPPLY INDICATOR Three colors of LED s to indicate the relative amount of gas available in a D E CO 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 Liter at 2 LPM maximum and delivery volume greater than 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 CO have been delivered Once 4 Liters have been delivered the unit automatically returns to stop mode Thereafter pressing the FLOW STOP RUN button a second time will resume the delivery of CO for an additional 2 Liters of CO Once an additional 2 Liters have been delivered the unit automatically returns to stop mode Subsequent presses of the FLOW STOP RUN button will deliver additional 2 Liter boluses of CO as required by the user The user can always depress the STOP RUN button during any of these volume increments
7. should distend more freely and redistribute the patient s weight on the CT table PROTOCO L Colon Insufflator User Manual Page 32 Possible Causes Field Checkout My CO supply Tank is Valve on CO supply tank prematurely emptying left open all of the time What could be the problem High Pressure Hose from CO supply tank is not installed properly We recommend attaching your PROTOCO L Colon Insufflator accessory to either D or E size CO supply tank Be sure to close the CO supply tank valve whenever the unit is not in use The pneumatic design of the PROTOCO L Colon Insufflator is not intended to provide a full time gas seal from the CO supply tank while the device is not being used or in storage Should the CO supply tank valve inadvertently be left open there is a high likelihood that the CO supply tank contents will gradually empty over several days If after opening and closing the CO supply tank valve with your procedure schedule you still encounter problems with CO supply tank prematurely emptying there is the possibility that the High Pressure Hose from the CO supply tank to the PROTOCO L Colon Insufflator unit is leaking Please inspect the High Pressure Hose in accordance with the following procedure Using an adjustable or Open Ended 3 4 wrench detach the High Pressure Hose from PROTOCO L Colon Insufflator s rear panel Inspect the tapered surface of the free standing
8. L Colon Insufflator User Manual Possible Causes Field Checkout CONTINUED My PROTOCO L Colon PROTOCO L Colon With the pressure holding steady between 35 to 45 mm Hg Insufflator is not distending Insufflator delivery pressure place the inflated Effluent Trap in your hand as shown the colon enough incorrect While in this position use your thumb to gently squeeze it flat What could be the problem As the Effluent Trap 1s 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 CO 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 PROTOCO L 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
9. 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 PROTOCO L Colon Insufflator User Manual Page 24 Z de ENA 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 PROTOCO L Colon Insufflator ensure the power is turned off and the ele
10. nipple on the PROTOCO L 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 Repeat this inspection procedure at the identical tapered gas connection at the CO supply tank valve Yoke Page 33 PROTOCO L Colon Insufflator User Manual Possible Causes Field Checkout CONTINUED My CO supply Tank is High Pressure Hose from prematurely emptying CO supply tank is not installed properly What could be the problem Inspect the CO supply tank Yoke and verify that the plastic disc that creates the gas seal at the CO5 supply tank valve is in place and free from defect After verifying all High Pressure Hose sealing surfaces are clean and free of defect reconnect the High Pressure Hose to the CO supply tank Yoke and PROTOCO L Colon Insufflator Use an adjustable or Opened Ended 4 wrench to tighten securely DO NOT USE ANY TEFLON TAPE OR THREAD SEALING COMPOUNDS Reconnect the Yoke to the CO supply tank valve making sure that the plastic sealing disk is in place Open the CO supply tank valve If CO continues to prematurely empty or should you hear CO escaping from any of these connections or the High Pressure Hose itself contact E Z EM Inc Customer Solutions PROTOCO L Colon Insufflator User Manual Page 34 Section 15 0 EMC TABLES
11. 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 what so ever concerning its installation or operation inform E Z EM Inc Customer Solutions at 1 800 544 4624 USA 1 516 333 8230 PROTOCO L Colon Insufflator User Manual Section 5 0 DESCRIPTION OF EQUIPMENT The PROTOCO L Colon Insufflator is indicated for use as a means of providing colonic distention 9 1 SPECIFICATIONS Size Weight Control Panel Gas Flow Pressure Adjustment Pressure Relief Valve Operating modes Gas Inlet 10 wide x 5 50 high x 10 deep 254 mm x 140 mm x 254 mm Less than 20 Ib 9 0 kg Push buttons and rotary dial Digital pressure and volume readouts 0 to 3 LPM 0 to 25 mm Hg operating 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 FLOW STOP RUN Single D E CO supply tank WARNING Do not allow liquid CO to enter the unit This can be prevented by assuring that the CO supply tank is maintained in a vertical position at all t
12. DISPLAY The Digital Volume Display reads the total volume of CO passing from the PROTOCO L Colon Insufflator to the patient The digital display indicates the volume of CO 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 Upon completion of the diagnostic procedure disconnect PROTOCO L 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 PROTOCO L M Administration Set Deflate retention cuff clamp administration set to prevent spillage of colonic fluids and remove tip Discard the entire PROTOCO L 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 Turn power off and disconnect the power cord from power outlet It is recommended that the CO supply tank valve be fully closed when not in use PROTOCO L Colon Insufflator User Manual section 11 0 DECONTAMINATION CLEANING AND STORAGE Prior to disinfecting the PROTOCO L Colon Insufflator ensure the power is turned off and the electrical cord is unplugged To disinfect the PROTOCO L Colon Insufflator wipe down with an inte
13. PORTANT If at any time the unit performs erratically or provides otherwise abnormal operation remove the unit from service and have it inspected or repaired The PROTOCO L Colon Insufflator should be inspected upon receipt and before each use Damaged equipment should be removed from service and returned to E Z EM Inc for repair or replacement Before each use perform the procedures and inspections described in Sections 9 1 9 2 and 9 3 9 1 INSUFFLATOR PREPARATION l Install the PROTOCO L Colon Insufflator on the Accessory Cart or on a flat surface away from potential sources of spraying or leaking liquids Visually inspect the PROTOCO L Colon Insufflator for external signs of damage 9 2 ELECTRICAL CONNECTIONS l Inspect the electrical connections Do not use if inspection reveals any damage 2 Connect the Power Cord to the AC Power Connection on the back of the PROTOCO L M Colon Insufflator Before connecting the power cord to the hospital grade wall outlet make sure that the main power switch is off and that the voltage 1s correct The PROTOCO L 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 PROTOCO L Colon Insufflator User Manual Page 14 9 3 CO HOSE CONNECTIONS iif
14. S SUPPLY A A Oo 8 e N y OUTPUT VOLUME RESET 00731G REV 04 10 Copyright 2006 E Z EM Inc All Rights Reserved
15. UN button is illuminated Check the Administration Set tubing for kinks closed clamps excessive colonic fluid or anything that could block the flow of CO into the patient Remind the patient to breathe orally Instruct the patient to relax his her abdominal muscles 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 If necessary additional CO up to 2 Liters may be added by pressing the FLOW STOP RUN button Lower than expected volume of CO A stabilized volume of less than 2 Liters of CO 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 b C Roll the patient onto either side to redistribute the CO in the colon Raise the pressure to 25 mm Hg 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 CO Continue with the rolling maneuver until the volume reaches at least 2 Liters 4 Higher than expected volume of CO If the volume pauses at 4 Liters one of th
16. ansportation or storage Therefore it 1s important to verify proper operation of the unit before use Page 17 l After power 1s applied to the unit verify that the front panel lights are enabled NOTE Ifthe output pressure 1s 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 CO supply tank valve is in the open position see Power On and Gas Supply Indicator 1 above 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 When the FLOW RUN STOP button is pressed initially 4 Liters of CO are delivered and the unit automatically returns to STOP mode Thereafter subsequent presses of the FLOW STOP RUN button will resume the delivery of CO 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 If the unit does not perform properly do not use Inspect the unit using the Troubleshooting guide Section 14 0 before returning fo
17. 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 1s 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 CO gas supply tank pressure is low Additionally the Gas Supply Indicator bar graph display will flash PROTOCO L Colon Insufflator User Manual Page 4 section 3 0 INSUFFLATOR THEORY OF OPERATION Page 5 The PROTOCO L Colon Insufflator operates by administering CO 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
18. ctrical cord is unplugged To disinfect the PROTOCO L 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 PROTOCO L 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 PROTOCO L 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 PROTOCO L Colon Insufflator including the warnings and cautions section Before making arrangements with E Z EM Inc Customer Solutions to send your PROTOCO L 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 PROTOCO L 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 comm
19. dips short interruptions and voltage variations on power supply input lines IEC 61000 4 8 Power frequency 50 60 Hz magnetic field 6 KV contact 8 KV air 2 KV for power supply lines 1 KV for input output lines 1 KV differential mode 2 KV common mode lt 5 Ut 295 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycles 70 Yo Ut 30 dip in Uf for 25 cycles lt 5 Ut gt 95 dip in Uf for 5 sec PROTOCO L Colon Insufflator User Manual 6 KV contact 8 KV air 2 KV for power supply lines 1 KV for input output lines 1 KV differential mode 2 KV common mode lt 5 Ut gt 95 dip in Ut for 0 5 cycle 40 Ut 60 Yo dip in Uf for 5 cycles 70 Yo Ut 30 dip in Uf for 25 cycles 5 Yo Ut 295 dip in Ut for 5 sec Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 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 Mains power quality should be that of a typical commercial or hospital environment If the user of the PROTOCOL Colon Insufflator requires continued operation during power mains interruptions it is recommended that the PROTOCOL Colon Insufflator be powered from an u
20. e 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 Small bowel reflux If reflux is evident and distention is acceptable proceed with study If additional CO 1s 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 Leakage around rectal tube If the colon is not fully distended and no small bowel reflux 1s 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 CO is required it may be added by depressing the FLOW STOP RUN button PROTOCO L Colon Insufflator User Manual Page 20 10 10 TERMINATING GAS FLOW amp SHUT DOWN PROCEDURES l Page 21 NOTE If an emergency should arise whereby there is a need to terminate insufflation the operator should stop the CO gas flow by promptly disconnecting the Administration Set at the PROTOCO L Colon Insufflator Output port 10 9 CO VOLUME
21. ed The customer or the user of the PROTOCOL Colon Insufflator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the PROTOCOL Colon Insufflator as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Read maximum output AA n power of transmitter 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 Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people PROTOCO L Colon Insufflator User Manual Page 38 BAA a asum AN Pree MIT Wi 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 OHH UK 44 0 1628 851500 UK Distributed in Canada by E Z EM Canada Inc Anjou Quebec H1J 274 Canada f e PROTOCOL COLON INSUFFLATOR 2 LITERS sal Il PRESSURE mmHg FLOW STOP RUN onn GA
22. ent 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 PROTOCO L Colon Insufflator User Manual Page 30 Possible Causes Field Checkout My PROTOCO L Colon PROTOCO L Colon To Check the PROTOCO L Colon Insufflator s ability to Insufflator is not distending Insufflator delivery pressure deliver CO at a set pressure please follow these verification the colon enough incorrect steps Attach an Administration Set to the Gas OUTPUT of your PROTOCO L Colon Insufflator Engage the tubing clamp What could be the problem oe 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 CO As the flow of CO 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 PROTOCO L Colon Insufflator should reach approximately 35 to 45 mm Hg Page 31 PROTOCO
23. ent to the prone position Immediately take the scout image Begin prone CT scan 10 8 OBSERVATIONS DURING INSUFFLATION Page 19 l 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 Ifthe unit is in RUN mode the flow of CO may be paused by pressing the FLOW STOP RUN button to allow time for the colon to relax Once the patient 1s 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 CO 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 PROTOCO L Colon Insufflator User Manual Ze 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 CO has not paused 1 e that the FLOW STOP R
24. 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 Page 23 Your new PROTOCO L 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 PROTOCO L Colon Insufflator which e Has been repaired by anyone other than an authorized E Z EM Inc representative e Has been altered in any way so as to in the judgment of E Z EM Inc affect its function e Has been subject to misuse negligence or accident including damage caused by contact with patient effluent or other substances PROTOCO L 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
25. imes Gas Input Pressure Patient Set 75 to 2200 PSI flow to 25 PSI Available for use with 0 1 micron hydrophobic filter E Z EM Inc supplies an Administration Set that includes this filter 9 2 ELECTRICAL REQUIREMENTS Input Voltage Power Standards 100 to 240 VAC nominal line voltage 50 60 Hz line voltage can vary by 10 from nominal 25 watts double fusing with removable power cord UL 2601 1 IEC 601 1 IEC 601 1 2 EN55011 EN60601 1 2 EN50082 1 EN61000 4 2 3 4 5 6 8 11 EN61000 3 2 3 PROTOCO L 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 Page 9 PROTOCO L Colon Insufflator User Manual Section 6 0 FRONT PANEL CONTROLS PROTOCGL COLON INSUFFLATOR S l o 00 oot a a a FLOW STOP RUN PRESSURE ON On nm GAS SUPPLY Ode o 5 py NY
26. ks Before each use the following procedures or inspections should be performed Visually inspect the PROTOCO L Colon Insufflator for external signs of damage Inspect the electrical connections Do not use if inspection reveals damage Before connecting the power cord to the wall outlet make sure the main power switch is off and that the voltage is correct Inspect the connection to the CO supply tank to assure it is intact and tight NOTE To assure maximum life of CO supply tank always close CO tank from the post valve when not in use PROTOCO L Colon Insufflator User Manual Page 16 Section 10 0 SETTING UP AND PERFORMING THE PROCEDURE 10 1 POWER ON AND GAS SUPPLY INDICATOR l Open the valve on the CO supply tank approximately turn Turn on the Power Switch Upon turn on all lights and indicators will be illuminated for a brief period 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 CO supply tank to finish a procedure as indicated below Lights Available CO Gas Green Tank Pressure is greater than 175 PSI Yellow Tank Pressure 1s 75 to 175 PSI Red Tank Pressure is less than 75 PSI Change Tank NOTE If CO 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 tr
27. n each frequency range a 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 PROTOCOL Colon Insufflator is used exceeds the applicable RF compliance level above the PROTOCO gt L 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 PROTOCOL Colon Insufflator Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Page 37 PROTOCO L Colon Insufflator User Manual Table 4 Recommended separation distances between Portable and mobile RF communications equipment and the PROTOCOL The PROTOCOL Colon Insufflator is intended for use in an electromagnetic environment in which radiated RF disturbances are controll
28. ninterruptible 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 Page 36 Table 3 Guidance and manufacturer s declaration electromagnetic immunity The PROTOCOL Colon Insufflator is intended for use in the electromagnetic environment specified below The customer or the user of the PROTOCO gt L 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 PROTOCOLL 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 3 Vrms 3 Vrms d 1 2VP 150 kHz to 80 MHz IEC 61000 4 3 Radiated RF 3 Vim 3 Vim d 12 P 80 MHz to 800 MHz 80 MHz to 2 5 GHz d 2 3NP 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 determined by an electromagnetic site survey should be less than the compliance level i
29. nnections are correctly installed and free of visible damage Should an unexplained rapid discharge of CO occur evacuate the immediate area until it has had sufficient time to ventilate High Pressure USP CO is supplied to the PROTOCO L Colon Insufflator from commercially available CO supply tanks Please read and carefully follow all Warnings Cautions and Handling Instructions provided with and listed on these CO supply tanks that are used with the PROTOCO L 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 1s required to ensure that benefits outweigh risks when this device 1s 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
30. on 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 Possible Causes Field Checkout My PROTOCO L Colon No power at wall outlet Check PROTOCO L Colon Insufflator in wall outlet known Insufflator does not to be operational Power up at all Blown fuse Remove power cord from rear panel of PROTOCO L What should I do Colon Insufflator and use a small screwdriver to open fuse holder If blown replace with 0 5 Amp 250 Volt Time Delay Fuses PROTOCO L Colon Insufflator User Manual Page 26 Possible Causes Field Checkout My PROTOCO L Colon Front panel rocker switch With unit plugged into wall outlet activate Power Switch to Insufflator does not Power off the ON or 1 position up at all Upon completing its Power up sequence the front panel What should I do should appear as follows 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 CO gt in the supply tank The above display indicates that the
31. 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 CO will gradually decrease when the current pressure approaches the user determined value on the Pressure Adjust Dial The colonic pressure has stabilized when the pressure shown on the Pressure Display equals the pressure set on the Pressure Adjust Dial and the flow of CO will stop While in the RUN mode the PROTOCO L Colon Insufflator will maintain the selected colonic pressure by continuously monitoring the current colonic pressure and will compensate for a loss in the colonic pressure by allowing additional CO to flow until the current pressure is equal again to the user determined colonic pressure setting The PROTOCO L Colon Insufflator has an electronically controlled Pressure Relief Valve at 50 mm Hg and an independent redundant mechanical Pressure Relief Valve pre set to 75 mm Hg Both pressure relief safety devices are active whether the Gas Flow is on or off PROTOCOL Colon Insufflator User Manual Section 4 0 WARNINGS AND CAUTIONS This section describes warning and caution information for safe operation of the PROTOCO L Colon Insufflator All information in this manual and particularly in this section should be read thoroughly and understood before using the device 4 1 WARNINGS If pneumoperitoneum free intra peritoneal air is observed or if colonic perfora
32. r service PROTOCOL 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 CO 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 PROTOCO L Colon Insufflator E Z EM Inc manufactures an Administration Set that includes the filter designed to provide optimum insufflator performance It is recommended that this Administration Set be used Always inspect every Administration Set to make 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 unauthori
33. rmediate 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 PROTOCO L 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 PROTOCO L Colon Insufflator can be wiped down with a damp cloth and mild soap The E Z EM Inc PROTOCO L 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 PROTOCO L Colon Insufflator User Manual Page 22 Section 12 0 REPAIR There are no user adjustments inside the PROTOCO L 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 PROTOCO L 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
34. se amp 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 Page 3 PROTOCO L Colon Insufflator User Manual Section 2 0 INTRODUCTION This manual provides information for the operation of the PROTOCO L Colon Insufflator also referred to in this manual as unit or device DEFINITIONS The following list 1s 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 PROTOCO L M 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 PROTOCO L Colon Insufflator should be used only when colon insufflation is indicated and should therefore not be used for any other treatments It should only be used under the direct guidance of a physician experienced in colon insufflation This device is contraindicated for hysteroscopic insufflation 1 e it must not
35. se 1 B ou Qualit H pital gt gt 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 CO to enter the unit This can be prevented by assuring that the CO 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 1s approved for use in your country AC input is with a standard hospital grade power cord Connection should be to hospital grade receptacles only PROTOCO L 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 Page 13 PROTOCO L Colon Insufflator User Manual Section 9 0 ASSEMBLY PRIOR TO COLON INSUFFLATION IM
36. tion is suspected at any time during the use of PROTOCO L insufflator immediately discontinue use and provide appropriate medical treatment Prior to use be sure to read all instructions for use on the PROTOCOL Administration Set Excessive absorption of CO 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 CO gas into open vascular channels Also adequate respiration helps avoid problems related to CO Should accidental intravasion of CO occur in rare circumstances it can result in embolization Infusion of CO can result in carbonic acid irritation to directly contacted tissues Use only USP Medical Grade CO 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 1s 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 ph
37. to stop delivery of CO PROTOCO L 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 Page 11 PROTOCO L Colon Insufflator User Manual section 7 0 REAR PANEL CONTROLS DANGER Equipment not suitable for use in presence of a flammable anesthetic mixture with air or T YAN oxygen or nitrous oxide 0 5A 250V DANGER NE Replace with Time Delay Ne jamais utiliser en pr scence d un m lange anesth siques Fuse As Marked CO INPUT inflammables contenant de l air de Utiliser un fusible de 2 l oxyg ne ou de l oxyde nitreux rechange du meme type 2200 PSI 150 Bar Max Use Only 100 240 V 75 VA 50 60 Hz Pre Filtered Medical Grade Gas WARNING See Instructions Grounding Reliability Can Only Be Utiliser exclusivement du gas Achieved When Connected To An medical pre filtre a une pression Equivalent Receptacle Marked maximum de 150 bar 2200 PSI Hospital Only Or Hospital Grade DANGER e ATTENTION K Une mise a la terre conforme ne peut tre obtenue que par la connexion a un r ceptacle Class 1 Type B IP31 quivalent marqu lt lt H pital Exclusivement gt gt Clas
38. 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 Page27 pRoTOCOJ MColonInsufflatorUserManual f Possible Causes Field Checkout My PROTOCO L Colon Empty CO supply tank or Insufflator does not deliver valve closed CO gt What could be the problem After successfully Powering up your PROTOCO L Colon Insufflator examine the GAS SUPPLY Indicator on the front panel Make sure that the tank Valve for the CO supply tank is open Your PROTOCO L Colon Insufflator should sense the pressure from the CO supply tank and the GAS SUPPLY Indicator should illuminate as follows 3 red 4 yellow and 3 green GAS SUPPLY If during Power up or operation of the PROTOCO L Colon Insufflator the CO 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 AS SUPPLY If this occurs reconnect the PROTOCO L M Colon Insufflator to a full CO supply tank to continue operation Should the PROTOCO L Colon Insufflator s CO Supply display fail to indicate full after verifying the CO supply tank 1s full and the tank
39. valve 1s open you will need to contact E Z EM Inc Customer Solutions PROTOCO L Colon Insufflator User Manual Page 28 Possible Causes Field Checkout My PROTOCO L Colon PROTOCO L Colon To check the PROTOCO L Colon Insufflator s ability to Insufflator does not deliver Insufflator flow rate deliver CO to the patient follow these verification steps CO2 incorrect After Powering up and making sure that your PROTOCO L Colon Insufflator is connected to the CO What could be the problem 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 CO 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 CO exiting from the PROTOCO L Colon Insufflator Page 29 PROTOCO L Colon Insufflator User Manual Possible Causes Field Checkout CONTINUED My PROTOCO L Colon Insufflator does not deliver CO gt What could be the problem PROTOCO L Colon Insufflator flow rate incorrect gt At start up your PROTOCO L Colon Insufflator should normally deliver the flow of CO to the pati
40. ysician 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 1s 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 PROTOCO L 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 CO absorption PROTOCO L Colon Insufflator User Manual Page 6 DEHP 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 PROTOCO L Administration Set at the Insufflator Output Port The PROTOCO L Colon Insufflator can release CO to the surrounding atmosphere in the event of misuse or a fault condition Use and store the PROTOCO L Colon Insufflator in a well ventilated environment Additionally make sure all CO supply tank co
41. zed 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 PROTOCO L Colon Insufflator User Manual Page 18 10 7 PATIENT INSUFFLATION 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 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 CO 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 Take the scout image Evaluate the quality of insufflation If insufflation is insufficient see OBSERVATIONS DURING INSUFFLATION below Begin supine CT scan Following the supine scan roll the pati
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