EZ EM PROTOCO2L 6400 Operator's Manual
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EZ EM PROTOCO2L 6400 Operator's Manual

Colon insufflator
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COLON INSUFFLATOR
REF 6400
Operator's Manual
0086
Rx Only (USA)

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Summary of Contents for EZ EM PROTOCO2L 6400

  • Page 1 COLON INSUFFLATOR REF 6400 Operator’s Manual 0086 Rx Only (USA)

  • Page 3: Table Of Contents

    TABLE OF CONTENTS SECTION 1.0 UNPACKING AND GENERAL INSPECTION ………………………………… 3 SECTION 2.0 INTRODUCTION..…………………………………………………………………...4 INDICATION AND CONTRAINDICATIONS............... 4 SAFETY FEATURES ........................ 4 SECTION 3.0 INSUFFLATOR THEORY OF OPERATION............5 SECTION 4.0 WARNINGS AND CAUTIONS................. 6 WARNINGS ..........................6 CAUTIONS ..........................7 SECTION 5.0 DESCRIPTION OF EQUIPMENT................

  • Page 4: Unpacking And General Inspection

    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.

  • Page 5: Introduction

    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 is abbreviations of commonly used terms throughout this manual: LPM Liter Per Minute (or Liters Per Minute) mm Hg millimeters of mercury gas CO 2 2.1 INDICATION AND CONTRAINDICATIONS...

  • Page 6: Insufflator Theory Of Operation

    Section 3.0 INSUFFLATOR THEORY OF OPERATION 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 on the front panel.

  • Page 7: Warnings And Cautions

    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 ...

  • Page 8: Cautions

     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™...

  • Page 9: Description Of Equipment

    Section 5.0 DESCRIPTION OF EQUIPMENT The PROTOCO L™ Colon Insufflator is indicated for use as a means of providing colonic distention. 5.1 SPECIFICATIONS Size: 10” wide x 5.50” high x 10” deep. 254 mm x 140 mm x 254 mm Weight: Less than 20 lb.

  • Page 10: Ul Equipment Classification

    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°...

  • Page 11: Front Panel Controls

    Section 6.0 FRONT PANEL CONTROLS 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" supply tank.
  • Page 12 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.

  • Page 13: Rear Panel Controls

    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 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.

  • Page 14: High Pressure Hose And Yoke Assembly

    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).

  • Page 15: Assembly Prior To Colon Insufflation

    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 PROTOCO L™ Colon Insufflator should be inspected upon receipt and before each use.

  • Page 16: Co 2 Hose Connections

    9.3 CO 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.
  • Page 17 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 tanks. Before each use the following procedures or inspections should be performed: Visually inspect the PROTOCO L™...

  • Page 18: Setting-Up And Performing The Procedure

    Section 10.0 SETTING-UP AND PERFORMING THE PROCEDURE 10.1 POWER ON AND GAS SUPPLY INDICATOR 1. Open the valve on the CO supply tank approximately 1 turn. Turn on the Power Switch. Upon turn on, all lights and indicators will be illuminated for a brief period.

  • Page 19: Setting Patient Pressure

    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.

  • Page 20: Patient Insufflation

    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.
  • Page 21 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.

  • Page 22: Co 2 Volume Display

    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 DISPLAY The Digital Volume Display reads the total volume of CO passing from the PROTOCO...

  • Page 23: Decontamination, Cleaning And Storage

    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 intermediate-level disinfectant (corrosive disinfectants, such as bleach, are not recommended since they may damage the equipment) in accordance with the manufacturer’s directions.

  • Page 24: Repair

    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™...

  • Page 25: Certification Of Non-Contamination

    This warranty does not cover routine cosmetic wear and tear on the system, including scratching and marring of this device. This warranty is in lieu of all other warranties, expressed or implied, including without limitation any implied warranty of merchantability or fitness for a particular use, and of all other obligations or liabilities on the part of E-Z-EM, Inc.

  • Page 26: Certificate Of Non-Contamination

    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.

  • Page 27: Troubleshooting Guide

    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™...
  • Page 28 Condition 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: Power Switch...
  • Page 29 Condition Possible Causes Field Checkout My PROTOCO L™ Colon After successfully Powering-up your PROTOCO L™ Colon Empty CO supply tank or Insufflator does not deliver Insufflator, examine the GAS SUPPLY Indicator on the front valve closed panel. Make sure that the tank Valve for the CO supply tank is open.
  • Page 30 Condition 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: incorrect After Powering-up and making sure that your PROTOCO L™...
  • Page 31 Condition Possible Causes Field Checkout “CONTINUED” My PROTOCO L™ Colon PROTOCO L™ Colon Insufflator does not deliver Insufflator flow rate incorrect What could be the problem? At start-up, your PROTOCO L™ Colon Insufflator should normally deliver the flow of CO to the patient incrementally as follows: 1 LPM for 0 to 0.5 Liters of delivered volume, 2 LPM for greater than 0.5 to 1 Liter of delivered volume and...
  • Page 32 Condition 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.
  • Page 33 Condition 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.
  • Page 34 Condition Possible Causes Field Checkout We recommend attaching your PROTOCO L™ Colon My CO supply Tank is Valve on CO supply tank Insufflator accessory to either “D” or “E” size CO supply prematurely emptying. left open all of the time. tank.
  • Page 35 Condition Possible Causes Field Checkout “CONTINUED” High Pressure Hose from My CO supply Tank is Inspect the CO supply tank Yoke and verify that the plastic prematurely emptying. supply tank is not disc that creates the gas seal at the CO supply tank valve is installed properly in-place and free from defect.

  • Page 36: Emc Tables

    Section 15.0 EMC TABLES 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 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.
  • Page 37 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.
  • Page 38 Table 3 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 test Compliance Immunity Test...
  • Page 39 Table 4 Recommended separation distances between Portable and mobile RF communications equipment and the PROTOCO The PROTOCO L Colon Insufflator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the PROTOCO L Colon Insufflator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PROTOCO...
  • Page 40 Manufactured for E-Z-EM, Inc. a subsidiary of Bracco Diagnostics Inc. 107 College Road East Princeton, NJ 08540 Phone: 1-(800) 544-4624 (USA), 1-(516) 333-8230 Bracco UK Ltd. Wooburn Green, Bucks, HP10 0HH, UK +44 (0) 1628 851500 (UK) Distributed in Canada by: E-Z-EM Canada Inc.

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