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Summary of Contents for Steris CO2EFFICIENT 710302
- Page 1 Endoscopic Insufflator REF 710302 Operator’s Manual Rx Only US Patent # 7,806,850 and US Patent # 8,157,763...
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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 THEORY OF OPERATION ..................5 SECTION 4.0 WARNINGS AND CAUTIONS................. 6 WARNINGS ..........................6 CAUTIONS .......................... -
Page 4: Unpacking And General Inspection
ENDOSCOPIC INSUFFLATOR, SUCH THAT ® OPERATION IS UNDERSTOOD. IF YOU SHOULD HAVE ANY QUESTIONS, PLEASE CONTACT STERIS CUSTOMER SERVICE AT 1- 800-548-4873 OR YOUR LOCAL STERIS ENDOSCOPY 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 CO EFFICIENT 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: Liter Per Minute (or Liters Per Minute) mm Hg millimeters of Mercury CO 2... -
Page 6: Theory Of Operation
Section 3.0 THEORY OF OPERATION The CO EFFICIENT ENDOSCOPIC INSUFFLATOR operates by administering 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. -
Page 7: Warnings And Cautions
Using unauthorized, non-STERIS Endoscopy brand tubing sets will void the • warranty. STERIS Endoscopy cannot assume any risk related to the use of non- STERIS Endoscopy brand product. Equipment is not suitable for use in the presence of a flammable anesthetic mixture •... -
Page 8: Cautions
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 CO Endoscopic Tubing Set at the unit’s Output Port. -
Page 9: Symbols
4.3 SYMBOLS Symbol and SDO (if Reference Title of Symbol Meaning of Symbol applicable) Number ISO 15223-1 5.1.1 Manufacturer Indicates the device manufacturer. Medical Devices – Symbols to be used with Medical Device 5.1.2 Authorized Representative in the European Community Labels, Labelling, and Information to... - Page 10 Symbol and SDO (if Reference Title of Symbol Meaning of Symbol applicable) Number 5.4.4 Caution Consult instructions for use for cautionary information. IEC 60417 5016 Fuse To identify fuse boxes or their location Graphical Symbols for Use on Equipment (ctd.) 5021 Equipotentiality Indicates the terminals which, when connected...
- Page 11 Symbol and SDO (if Reference Title of Symbol Meaning of Symbol applicable) Number BS EN 15986 Contains or presence of Phthalates Indicates the presence of Phthalates Symbol for use in the labeling medical devices – requirements for labeling of medical devices containing phthalates...
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Page 12: Description Of Equipment
Gas Input Pressure: 75 to 2200 psi, flow to 25 psi. Tubing Set: Available for use with ≤0.1 micron hydrophobic filter. STERIS Endoscopy supplies a Tubing Set that includes this filter. 5.2 ELECTRICAL REQUIREMENTS Input Voltage: 100 to 240 VAC nominal line voltage; 50/60 Hz. -
Page 13: 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 hPascal 20.7 to 31.3 (inches of Mercury) Storage Temperature: 32°... -
Page 14: Front Panel Controls
Section 6.0 FRONT PANEL CONTROLS NOTE: The appearance of your CO EFFICIENT 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”... - Page 15 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.
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Page 16: Rear Panel Controls
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 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 17: 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 18: Assembly Prior To Use
EFFICIENT ENDOSCOPIC INSUFFLATOR should be inspected upon receipt and before each use. Damaged equipment should be removed from service and returned to STERIS Endoscopy 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... -
Page 19: Co Hose Connections
9.3 CO 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. - Page 20 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 CO EFFICIENT ENDOSCOPIC INSUFFLATOR for external...
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Page 21: Setting-Up For The Procedure
Section 10.0 SETTING-UP FOR 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 22: Tubing Set Connection
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 STERIS Endoscopy manufactured high flow tubing labeled as STERIS Endoscopy CO Endoscopic Tubing Set (that includes a ≤0.1 micron hydrophobic filter) designed to provide optimum performance. -
Page 23: System Set-Up
Figure 10.2 Example Olympus Water bottle with CO Connection MAJ-902 ® PENTAX is the registered trademark of Hoya Corporation. ® Olympus is the registered trademark of Olympus Corporation. 10.7 SYSTEM SET-UP The following operational sequence describes the system set-up for both the EFFICIENT ENDOSCOPIC INSUFFLATOR and Tubing Set: Make sure the CO EFFICIENT ENDOSCOPIC INSUFFLATOR is... -
Page 24: Co Volume Display
Connect Tubing Set Luer fitting to the endoscopic system. vii) Connect the Tubing Set fitting to CO EFFICIENT ENDOSCOPIC INSUFFLATOR. viii) Start the endoscopic system by turning on the necessary light and video equipment. Verify that the air supply from the endoscopic system is turned off. Start CO EFFICIENT ENDOSCOPIC INSUFFLATOR by pressing the FLOW STOP/RUN button. -
Page 25: Decontamination, Cleaning And Storage
Warranty repairs will be made without charge. All other repairs will be made on a time and material basis. If requested, STERIS Endoscopy will provide an estimate of the repair cost and the time for the repair before any work is done. Repair items... -
Page 26: Maintenance Checks
EFFICIENT ENDOSCOPIC INSUFFLATOR. If it is worn, frayed, kinked or damaged, call STERIS Endoscopy immediately to obtain a replacement. Confirm hose is firmly attached to unit and a “D” or “E” sized medical grade CO tank. - Page 27 MAINTENANCE CHECKLIST Refer to Section 11.1 of this Operator’s Manual for instructions on how to perform each item in the checklist below: 1. Inspection of line cord (mains lead) Pass Fail 2. High Pressure Hose Inspection Pass Fail 3. Front Panel Rocker Switch Inspection Pass Fail Pass...
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Page 28: Customer Services And Ordering Information
INSUFFLATOR which: Has been repaired by anyone other than an authorized STERIS Endoscopy • representative. Has been altered in any way so as to, in the judgment of STERIS Endoscopy, • affect its function. • Has been subject to misuse, negligence, or accident, including damage caused by contact with patient effluent or other substances. -
Page 29: Certificate Of Non-Contamination
SERIAL No.: RA. No.: The above person hereby certifies that the above described product being returned to STERIS Endoscopy 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 30: Troubleshooting Guide
The Field Checkout steps listed here pertain to common operating conditions and possible malfunctions. Review this information and refer to it when communicating with your STERIS Customer Service Representative. This will enable us to identify the best course of action to meet your service needs. - Page 31 Condition Possible Causes Field Checkout My CO EFFICIENT ENDOSCOPIC No power at wall outlet. Check CO EFFICIENT ENDOSCOPIC INSUFFLATOR in INSUFFLATOR does not wall outlet known to be operational. power-up at all. Remove power cord from rear panel of CO EFFICIENT What should I do? Blown fuse.
- Page 32 Condition Possible Causes Field Checkout My CO EFFICIENT ENDOSCOPIC Front panel rocker power With unit plugged into wall outlet, activate Power Switch to INSUFFLATOR does not switch is “off”. the ON or (1) position. power-up at all. Upon completing its Power-up sequence, the front panel What should I do? should appear as follows: Power Switch...
- Page 33 Condition Possible Causes Field Checkout My CO EFFICIENT After successfully powering-up your CO EFFICIENT Empty CO supply tank or ENDOSCOPIC ENDOSCOPIC INSUFFLATOR, examine the GAS valve closed. INSUFFLATOR does not SUPPLY Indicator on the front panel. deliver CO Make sure that the tank valve for the CO supply tank is open.
- Page 34 Condition Possible Causes Field Checkout My CO EFFICIENT EFFICIENT To check the CO EFFICIENT ENDOSCOPIC ENDOSCOPIC ENDOSCOPIC INSUFFLATOR’s ability to deliver CO to the patient, INSUFFLATOR does not INSUFFLATOR flow rate follow these verification steps: incorrect. deliver CO After powering-up and making sure that your EFFICIENT ENDOSCOPIC INSUFFLATOR is connected to the CO supply tank, depress the VOLUME...
- Page 35 Condition Possible Causes Field Checkout We recommend attaching your CO EFFICIENT My CO supply tank is Valve on CO supply tank ENDOSCOPIC INSUFFLATOR accessory to either “D” or prematurely emptying. left open all of the time. “E” size CO supply tank. For days when the EFFICIENT ENDOSCOPIC INSUFFLATOR is What could be the problem? scheduled for continuous use, the CO...
- Page 36 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 supply tank is not prematurely emptying. disc that creates the gas seal at the CO supply tank valve is installed properly.
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Page 37: Emc Tables
Section 14.0 EMC TABLES The CO EFFICIENT ENDOSCOPIC INSUFFLATOR has been tested by Underwriters Laboratory to the following electromagnetic compatibility standards: Table 1 Guidance and manufacturer’s declaration – electromagnetic emissions The CO EFFICIENT ENDOSCOPIC INSUFFLATOR is intended for use in the electromagnetic environment specified below. - Page 38 Table 2 Guidance and manufacturer’s declaration – electromagnetic immunity The CO EFFICIENT ENDOSCOPIC INSUFFLATOR is intended for use in the electromagnetic environment specified below. The customer or the user of the CO EFFICIENT ENDOSCOPIC INSUFFLATOR should assure that it is used in such an environment. IEC 60601 Electromagnetic environment –...
- Page 39 Table 3 Guidance and manufacturer’s declaration – electromagnetic immunity The CO EFFICIENT ENDOSCOPIC INSUFFLATOR is intended for use in the electromagnetic environment specified below. The customer or the user of the CO EFFICIENT ENDOSCOPIC INSUFFLATOR should assure that it is used in such an environment.
- Page 40 Table 4 Recommended separation distances between Portable and mobile RF communications equipment and the EFFICIENT ENDOSCOPIC INSUFFLATOR The CO EFFICIENT ENDOSCOPIC INSUFFLATOR is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CO EFFICIENT ENDOSCOPIC INSUFFLATOR can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CO...
- Page 41 Unless otherwise indicated, all marks denoted with ® or ™ are registered with the U.S. Patent and Trademark Office, or are trademarks owned by STERIS Corporation. Serious incidents that have occurred in relation to this medical device should be reported to the manufacturer and competent authority in the country where the incident occurred.
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