Olympus Medical Systems RU2020 Endoscope Reprocessor User Manual GT9882 0100 fm10
Olympus Medical Systems Corp. Endoscope Reprocessor GT9882 0100 fm10
Contents
Operation Manual 1
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| Document ID | 3575657 |
| Application ID | 5WVuu3vD2TKx6k5P50iqxA== |
| Document Description | Operation Manual 1 |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | Yes |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 226.6kB (2832518 bits) |
| Date Submitted | 2017-09-22 00:00:00 |
| Date Available | 2018-03-21 00:00:00 |
| Creation Date | 2017-09-13 15:44:28 |
| Producing Software | Acrobat Distiller 9.2.0 (Windows) |
| Document Lastmod | 2017-09-14 09:26:55 |
| Document Title | GT9882_0100_fm10.book |
| Document Creator | FrameMaker 10.0.2 |
| Document Author: | 10014848 |
OPERATION MANUAL INSTRUCTIONS Labels and Symbols Important Information — Please Read Before Use Chapter 1 Checking the Package Contents 19 Chapter 2 Nomenclature and Functions 23 Chapter 3 Basic Operation 35 Chapter 4 Settings 75 Chapter 5 Inspection and Preparation Before Use 127 Chapter 6 Reprocessing Operations 147 Chapter 7 Functions 239 Chapter 8 Replacement of Consumable Items 339 Routine Maintenance 423 ENDOSCOPE REPROCESSOR OER-Elite¥ Chapter 9 Chapter 10 End-of-Day Checks 451 Chapter 11 Log Management 463 Chapter 12 Information Menu Screen 589 Chapter 13 Troubleshooting and Repair 599 Appendix 647 For details on installation and setup, refer to “Instructions - Installation Manual”. Contents Contents Labels and Symbols .......................................................................................................... 1 Important Information — Please Read Before Use ......................................................... 7 Intended use .......................................................................................................................... 7 Instruction manuals ............................................................................................................... 7 Terms used in these manuals ................................................................................................ 8 User qualifications ................................................................................................................ 11 Ensuring the safety of reprocessing personnel ................................................................... 12 Equipment compatibility ....................................................................................................... 13 Care and storage ................................................................................................................. 13 Maintenance and Inspection ................................................................................................ 13 Repair and modification ....................................................................................................... 13 Disposal of disinfectant solution .......................................................................................... 14 Disposal of this reprocessor ................................................................................................ 14 Signal words ........................................................................................................................ 14 Warnings and cautions ........................................................................................................ 14 Outline of Functions ........................................................................................................ 16 Chapter 1 Checking the Package Contents ....................................... 19 1.1 Checking the package contents ............................................................................ 19 Chapter 2 Nomenclature and Functions ............................................ 23 2.1 Front panel .............................................................................................................. 23 2.2 Top panel ................................................................................................................. 24 2.3 Inside ....................................................................................................................... 25 2.4 Rear panel ............................................................................................................... 26 2.5 Side panel ................................................................................................................ 27 2.6 Reprocessing basin ............................................................................................... 28 2.7 Control panels ........................................................................................................ 30 2.8 Consumable accessories (Optional) .................................................................... 31 Chapter 3 Basic Operation .................................................................. 35 3.1 Turning power ON .................................................................................................. 35 3.2 Alarm indicator ....................................................................................................... 37 3.3 Control panel operation ......................................................................................... 40 3.4 Menu screen ........................................................................................................... 41 3.5 LCG Info. screen ..................................................................................................... 42 OER-Elite OPERATION MANUAL Contents 3.6 Entering ID .............................................................................................................. 44 Entering through the RFID reader ....................................................................................... 45 Entering by the software keyboard ...................................................................................... 48 Entering the patient ID by the optional bar code ................................................................. 65 3.7 Checking the MRC level and entering the check result ...................................... 69 Required items .................................................................................................................... 70 Checking the MRC level ...................................................................................................... 70 Chapter 4 Settings ................................................................................ 75 4.1 Setting menu ........................................................................................................... 75 4.2 Auto leak test setting ............................................................................................. 79 4.3 MRC check setting ................................................................................................. 81 4.4 Manual cleaning and leak test setting .................................................................. 82 4.5 User ID Setting ........................................................................................................ 83 User ID setting (reprocessing) ............................................................................................. 84 User ID setting (functions and replacement) ....................................................................... 86 User ID setting (Heat LCG Timer) ....................................................................................... 87 4.6 Physician ID setting ............................................................................................... 88 4.7 Patient ID setting .................................................................................................... 89 4.8 Patient ID security setting ..................................................................................... 90 4.9 Procedure ID setting .............................................................................................. 91 4.10 Detergent replacement indicator .......................................................................... 92 4.11 Detergent lot number and shelf-life management ............................................... 94 4.12 LCG replacement indicator .................................................................................... 95 4.13 LCG lot number and shelf-life management ........................................................ 98 4.14 Filter replacement indicator .................................................................................. 99 4.15 Filter lot number management ............................................................................ 103 4.16 Auxiliary water tube cleaning setting ................................................................. 104 4.17 Print option ........................................................................................................... 106 Print format setting ............................................................................................................ 107 Auto Print Setting ............................................................................................................... 108 4.18 Start screen ........................................................................................................... 109 4.19 Connection guide ................................................................................................. 110 4.20 Volume and brightness ........................................................................................ 111 4.21 Date and time ........................................................................................................ 112 4.22 Temperature scale ................................................................................................ 115 4.23 Network setting ..................................................................................................... 116 4.24 Network security ................................................................................................... 121 ii OER-Elite OPERATION MANUAL Contents Chapter 5 Inspection and Preparation Before Use .......................... 127 5.1 Inspection before use .......................................................................................... 127 5.2 Flow of inspection ................................................................................................ 128 5.3 Inspecting the power activation .......................................................................... 129 5.4 Inspecting for fluid leaks ..................................................................................... 132 5.5 Inspecting the lid and lid packing ....................................................................... 133 5.6 Inspecting the connectors ................................................................................... 134 5.7 Inspecting the connecting tubes and leak test air tube ................................... 137 5.8 Inspecting the remaining detergent ................................................................... 138 5.9 Inspecting and replenishing alcohol .................................................................. 139 Inspection of the amount of alcohol ................................................................................... 140 Replenishing of alcohol ..................................................................................................... 140 5.10 Inspecting the mesh filters .................................................................................. 143 5.11 Inspecting the washing case (MAJ-2121) .......................................................... 144 5.12 Inspecting the labels on the reprocessing basin .............................................. 145 5.13 Inspecting for disinfectant solution odor ........................................................... 145 Chapter 6 Reprocessing Operations ................................................ 147 6.1 General flow of endoscope reprocessing using OER-Elite .............................. 147 6.2 Precleaning, leak testing, and manual cleaning ................................................ 148 Modified manual cleaning process for preparing endoscopes for processing in the OER-Elite ........................................................................................................................... Endoscope precleaning (Procedure performed at bedside immediately after patient examination) ........................ Endoscope precleaning continued (Procedure performed at bedside immediately after patient examination) ........................ Leakage testing ................................................................................................................. Manual cleaning (procedure performed in reprocessing area) .......................................... Loading the endoscope and their accessories into the OER-Elite .................................... 6.3 149 149 150 152 152 154 Reprocessing operation in the OER-Elite .......................................................... 155 Warnings ............................................................................................................................ 155 Outline of reprocessing operation in the OER-Elite ........................................................... 157 6.4 Worst case load condition of endoscopes and accessories ........................... 158 6.5 Basic operation for reprocessing ....................................................................... 160 Reprocessing standby screen ........................................................................................... 160 Reprocessing program ...................................................................................................... 162 OER-Elite OPERATION MANUAL iii Contents 6.6 Loading of endoscopes and accessories .......................................................... 163 Outline of loading operation of endoscopes and accessories ........................................... 163 Input scope ID of first endoscope ...................................................................................... 165 Loading of first endoscopes in the reprocessing basin ...................................................... 166 Loading of the accessories of first endoscope (valves, etc.) ............................................. 173 Attaching the connecting tubes loading to first endoscope ............................................... 177 Loading of auxiliary water tube of first endoscope ............................................................ 186 Attaching the Leak test air tube loading to first endoscope ............................................... 189 Input connection information of first endoscope ................................................................ 194 Input results of manual cleaning and leak test of first endoscope ..................................... 195 Inputs user ID, physician ID, patient ID, and procedure ID of first endoscope .................. 196 Input scope ID of second endoscope ................................................................................ 197 Loading of second endoscopes in the reprocessing basin ................................................ 197 Loading of the accessories of second endoscope (valves, etc.) ....................................... 202 Attaching the connecting tubes loading to second endoscope .......................................... 205 Loading of auxiliary water tube of second endoscope ........................................................ 211 Attaching the Leak test air tube loading to second endoscope ......................................... 213 Input connection information of second endoscope .......................................................... 214 Input results of manual cleaning and leak test of second endoscope ............................... 214 Inputs user ID, physician ID, patient ID, and procedure ID of second endoscope ............ 214 Loading the stylus pen ....................................................................................................... 215 6.7 Inspection before starting reprocessing process ............................................. 216 6.8 Reprocessing ........................................................................................................ 220 Auto leak test ..................................................................................................................... 221 Channel monitoring ........................................................................................................... 223 Reprocessing operation ..................................................................................................... 225 6.9 Removing the endoscopes and accessories ..................................................... 228 6.10 Printing of the reprocessing records ................................................................. 232 Printing reprocessing results after completion of reprocessing ......................................... 234 Printing error code details in case of error ......................................................................... 237 Chapter 7 Functions ........................................................................... 239 7.1 Function menu ...................................................................................................... 239 Function menu ................................................................................................................... 239 7.2 Heat LCG ............................................................................................................... 242 7.3 Heat LCG Timer ..................................................................................................... 244 Flow of Heat LCG Timer .................................................................................................... Starting the Heat LCG Timer ............................................................................................. Standing by and starting the Heat LCG Timer ................................................................... Finishing the Heat LCG Timer ........................................................................................... iv 245 245 253 254 7.4 Mix LCG ................................................................................................................. 255 7.5 Rinse ...................................................................................................................... 258 7.6 Air purge ................................................................................................................ 260 OER-Elite OPERATION MANUAL Contents 7.7 Water line disinfection ......................................................................................... 262 Workflow of water line disinfection ..................................................................................... Required items .................................................................................................................. Checking the MRC level and entering the check result ..................................................... Water line disinfection ........................................................................................................ 7.8 Self-disinfection and water sampling ................................................................. 274 Workflow of self-disinfection .............................................................................................. Required items .................................................................................................................. Checking the MRC level and entering the check result ..................................................... Performing the self-disinfection ......................................................................................... Microbiological Surveillance .............................................................................................. 7.9 263 264 264 266 274 275 275 277 281 Detergent line disinfection .................................................................................. 282 Required items .................................................................................................................. 283 Detergent line disinfection ................................................................................................. 283 7.10 Alcohol line disinfection ...................................................................................... 293 Required items .................................................................................................................. 294 Alcohol line disinfection ..................................................................................................... 294 7.11 Manual leak test .................................................................................................... 303 Workflow of manual leak test ............................................................................................. 304 Performing manual leak test .............................................................................................. 305 7.12 Auto leak test ........................................................................................................ 310 Workflow of auto leak test .................................................................................................. 312 Performing auto leak test ................................................................................................... 313 7.13 Self-check of auto leak test ................................................................................. 321 7.14 Alcohol flush ......................................................................................................... 323 7.15 Leaking scope decontamination ......................................................................... 326 Workflow of leaking scope decontamination ...................................................................... 328 Required items .................................................................................................................. 328 Performing leaking scope decontamination ....................................................................... 329 Chapter 8 Replacement of Consumable Items ................................ 339 8.1 Replacement of consumable items menu .......................................................... 339 8.2 Replacing the disinfectant solution .................................................................... 340 Workflow of replacement the disinfectant solution ............................................................. Draining the disinfectant solution ....................................................................................... Load the disinfectant solution ............................................................................................ Required items .................................................................................................................. Setting the disinfectant solution ......................................................................................... 8.3 341 342 354 355 356 Replacing the detergent tank .............................................................................. 364 Required item .................................................................................................................... 365 Replacing the detergent tank ............................................................................................. 366 OER-Elite OPERATION MANUAL Contents 8.4 Replacing the water filter (MAJ-824 or MAJ-2318) ............................................ 375 Replacing the water filter workflow (when performing the water line disinfection followed by the replacement of the water filter) .......................................................................................... 377 Required items .................................................................................................................. 377 MRC check, check result input .......................................................................................... 378 Replacing the water filter ................................................................................................... 380 Draining air in the water filter housing ............................................................................... 389 Disinfecting the water line .................................................................................................. 392 8.5 Replacing the air filter (MAJ-823) ........................................................................ 402 Workflow of replacement of the air filter ............................................................................ Required items .................................................................................................................. Replacing the air filter ........................................................................................................ Inspecting air leakage from the air filter connectors .......................................................... 8.6 402 402 403 408 Replacing the gas filter (MAJ-822) ...................................................................... 411 Required items .................................................................................................................. 412 Replacing the gas filter on the lid ...................................................................................... 412 Replacing the gas filter on the disinfectant solution tank ................................................... 416 Chapter 9 Routine Maintenance ........................................................ 423 9.1 Periodic inspection .............................................................................................. 423 9.2 Cleaning the detergent/alcohol drawer .............................................................. 425 9.3 Cleaning the accessories and accessory holder .............................................. 426 Required items .................................................................................................................. 426 Cleaning the accessories and accessory holder ............................................................... 426 9.4 Cleaning the alcohol tank .................................................................................... 428 9.5 Checking cassette cutters ................................................................................... 429 9.6 Cleaning the disinfectant bottle drawer ............................................................. 429 9.7 Cleaning the mesh filter in the water supply hose connector .......................... 430 Required items .................................................................................................................. 430 Cleaning the mesh filter in the water supply hose connector ............................................ 430 9.8 Replacing the fuse ................................................................................................ 434 9.9 Preparing the reprocessor for long-term storage ............................................. 436 Workflow of Preparing the reprocessor for long-term storage ........................................... 437 Required items .................................................................................................................. 437 Preparing the reprocessor for long-term storage ............................................................... 438 9.10 Care and maintenance after long-term storage ................................................. 448 Chapter 10 End-of-Day Checks ........................................................... 451 10.1 Inspection at the end of every working day ....................................................... 451 10.2 Turning the power OFF and closing the water faucet ....................................... 452 10.3 Cleaning the mesh filters ..................................................................................... 453 10.4 Cleaning the float switches ................................................................................. 454 10.5 Cleaning the fluid level sensor ............................................................................ 458 vi OER-Elite OPERATION MANUAL Contents 10.6 Cleaning the stylus pen ....................................................................................... 460 Wiping the stylus pen with alcohol ..................................................................................... 460 Reprocessing together with endoscopes ........................................................................... 460 10.7 Cleaning the outer surface .................................................................................. 461 Chapter 11 Log Management .............................................................. 463 11.1 Log menu .............................................................................................................. 463 11.2 Log display and output ........................................................................................ 464 Information recorded in each record .................................................................................. 470 11.3 Log management with PC ................................................................................... 533 Flow of electronic log management ................................................................................... Required item .................................................................................................................... Output of recorded data to the portable memory ............................................................... Log management on PC .................................................................................................... 534 534 535 541 11.4 Printing records .................................................................................................... 575 Printing .............................................................................................................................. 575 Print format ........................................................................................................................ 579 Chapter 12 Information Menu Screen ................................................. 589 12.1 RFID data check .................................................................................................... 589 12.2 Reprocessor information check ......................................................................... 592 12.3 List management .................................................................................................. 595 Chapter 13 Troubleshooting and Repair ............................................ 599 13.1 Emergency stop and automatic processing after stopping ............................. 599 13.2 Troubleshooting guide ......................................................................................... 600 When the error code [E024] is displayed during the reprocessing process ...................... When any leaks are detected ............................................................................................ When the message screen “Message 087” is displayed ................................................... When the “Message 093” is displayed .............................................................................. Other problems and remedial actions ................................................................................ 614 617 627 635 642 13.3 OER-Elite return ................................................................................................... 645 Appendix ............................................................................................... 647 System chart .................................................................................................................. 647 Specifications ................................................................................................................ 649 Shipping environment ........................................................................................................ 649 Operating environment ...................................................................................................... 649 Specifications ..................................................................................................................... 650 EMC information ............................................................................................................ 653 License information of Open Source Software ........................................................... 658 License information of Open Source Software ........................................................... 670 OER-Elite OPERATION MANUAL vii Contents viii OER-Elite OPERATION MANUAL Labels and Symbols Labels and Symbols The meaning(s) of the symbol(s) shown on the component packaging, the back cover of this instruction manual and/or this reprocessor are as follows: Symbol Description Refer to instructions. Endoscope reprocessor Manufacturer Authorized representative in the European Community Lot number Serial number Non-ionizing electromagnetic radiation Date of manufacture Fuse General prohibition sign For US Customers only For a Symbols Glossary, visit us: http://www.olympus-global.com/en/common/pdf/symbolsglossary.pdf Safety-related labels and symbols are attached to the reprocessor at the locations shown next page. If labels or symbols are missing or illegible, contact Olympus. OER-Elite OPERATION MANUAL Labels and Symbols Front panel UDI label A label required by some countries’ regulations regarding identification of medical device also known as Unique Device Identification (UDI). RFID marking OER-Elite OPERATION MANUAL Labels and Symbols Inner side FRA Rotation direction indicator label Indicates the rotation direction for locking and releasing gas filter case (tank). Rating plate Shows the product model, power rating, and serial number. FRA Date of manufacture OER-Elite OPERATION MANUAL Labels and Symbols Rear panel CSA/UL MARKING OER-Elite OPERATION MANUAL Labels and Symbols Top panel FRA Rotation direction indicator label Indicates the rotation directions for locking and releasing gas filter case (lid). FRA FRA OER-Elite OPERATION MANUAL Labels and Symbols Reprocessing basin Fonts displayed on the touch screen Ricoh bitmap fonts designed by RICOH Company, Ltd. are used. OER-Elite OPERATION MANUAL Important Information — Please Read Before Use Important Information — Please Read Before Use Intended use The OER-Elite is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Safe use requires detergent and an FDA-cleared high-level disinfectant/sterilant that Olympus has validated to be efficacious and compatible with the materials of the OER-Elite and Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Use of a detergent or high-level disinfectant/sterilant that has not been validated by Olympus may be ineffective and can damage the OER-Elite components and the endoscopes being reprocessed. Endoscopes must be cleaned by the user prior to reprocessing; however, use of the OER-Elite enables the user to perform modified manual cleaning of some endoscopes prior to automated cleaning and high-level disinfection in the OER-Elite. Instruction manuals The instructions for this reprocessor are divided into two volumes: “Instructions-Installation Manual”, and “Instructions-Operation Manual”. Instructions regarding the preparation of endoscopes prior to placing them in the OER-Elite are found in “Instructions-Operation Manual”. Each of these manuals contains essential information for using this reprocessor safely and effectively. The “Instructions-Installation Manual” describes how to install the reprocessor. The “Instructions-Operation Manual” describes how to operate and maintain the reprocessor and describes modifications to the manual endoscope cleaning process that can save the user time and inconvenience, if the endoscope is going to be subsequently reprocessed using the OER-Elite. The “List of Compatible Endoscopes/Connecting Tubes” identifies all Olympus model endoscopes that are compatible with the OER-Elite, plus the specific connecting tube(s) required for each of these endoscope models. The descriptions in these manuals assume that all endoscopes are reprocessed in the OER-Elite using both an Olympus-validated detergent and disinfectant. Contact Olympus to obtain the list of both Olympus-validated disinfectant solutions and detergents. Before using this reprocessor, be sure to review all of the above-mentioned manuals, the safety information provided with Olympus-validated detergents and disinfectants, and the manuals for all other equipment used in the process. Always use this reprocessor as instructed. It might cause unexpected danger if you do not follow the installation and operation manual. Keep these and all related instruction manuals and documents in a safe and accessible location. If you have any questions or comments about any information in these manuals, contact Olympus. OER-Elite OPERATION MANUAL Important Information — Please Read Before Use Terms used in these manuals ALT Stands for Auto Leak Test. Air purge In this operation, air is fed into an endoscope channel to blow out residual fluid. This operation is usually performed automatically during a process, but it can also be activated independently. Air purge is also used to drain cleaning fluid or disinfectant solution from inside the reprocessor when the operation has stopped due to an error code, etc. Alcohol 70% ethyl alcohol or 70% isopropyl alcohol. Alcohol flush To assist in drying the channels after reprocessing, alcohol is flushed through the endoscope channels followed by air. This operation can be performed as the last step of the reprocessing program or as an independent operation. Automatic processing When the reprocessor is stopped by the operator or due to an error, it identifies its status and executes the optimum operation automatically. For example, if the reprocessor stops in the middle of the disinfection process, it terminates the disinfection process and removes the disinfectant solution. Channel blockage monitoring This function monitors the channel blockage of endoscope’s suction channel due to a foreign object, etc., during a reprocessing program. Channel connectivity monitoring This function monitors the connection status of the connecting tubes during a reprocessing program. Channel monitoring “Channel monitoring” will be used as a generic term meaning “Channel connectivity monitoring” and “Channel blockage monitoring”. Cleaning fluid Refers to filtered water with detergent that is used during the cleaning process. Cleaning process A series of operations programmed into the reprocessor that enable it to perform ultrasonic cleaning and detergent cleaning of endoscopes. OER-Elite OPERATION MANUAL Important Information — Please Read Before Use Detergent Olympus-validated detergent. Refer to Section 2.8, “Consumable accessories (Optional)” for details. Disinfectant solution Olympus-validated disinfectant solution. Refer to Section 2.8, “Consumable accessories (Optional)” for details. Disinfection process A series of operations programmed into the reprocessor that enable it to perform disinfection of endoscopes. Error code A code consisting of [E] and a three-digit number. This code is displayed on the touch screen if there is a problem with the reprocessor. When an error code is displayed, check the troubleshooting guide. LCG Liquid Chemical Germicide. It refers to disinfectant solution displayed on GUI. Leak test A test to confirm that an endoscope is free of leaks. This reprocessor is capable of both the auto leak test and the manual leak test. Manual cleaning Cleaning of an endoscope by hand. Modified precleaning and manual cleaning A precleaning and manual cleaning method that is simplified due to subsequent use of the OER-Elite which automates cleaning steps in the process. MRC Minimum Recommended Concentration. Patient ID Identity information specific to each patient. It can be recorded in the histories of reprocessing, etc. For the patient ID input method, refer to Section 3.6, “Entering ID”. Physician ID Identity information specific to each endoscopist. It can be recorded in the histories of reprocessing, etc. For the physician ID input method, refer to Section 3.6, “Entering ID”. Portable memory A digital medium for storage. OER-Elite OPERATION MANUAL Important Information — Please Read Before Use Precleaning Cleaning of an endoscope performed after each procedure at the bedside in the endoscopy room. Procedure ID Identity information specific to each procedure of the patient. It can be recorded in the histories of reprocessing, etc. For the procedure ID input method, refer to Section 3.6, “Entering ID”. Process Generic term for any operation, including cleaning and disinfection that is performed automatically by this reprocessor. Reprocessing process A series of operations for ultrasonic cleaning, detergent cleaning, disinfection, rinse, air purge, and alcohol flush of the outer surface or channels of endoscopes that run in a specified sequence and for a specified time. Reprocessing programs [1] to [4] can be selected by the user. Programs [1] to [4] have a fixed cleaning process time and disinfection process time. They also have different patterns of auto leak test and channel monitoring respectively. Scope ID Identity information specific to each endoscope. It can be recorded in the historical data of reprocessing, etc. For the scope ID input method, refer to Section 3.6, “Entering ID”. Shelf life The date of expiration of the effectiveness of a detergent or disinfectant before it is opened. Test strip Device used to test if the concentration of disinfectant solution is effective for disinfection. Refer to Section 2.8, “Consumable accessories (Optional)” for details. (i.e., the minimum recommended concentration (MRC) specified by the disinfectant manufacturer) User ID Identity information specific to each reprocessing operator. It can be recorded in the histories of reprocessing, etc. For the user ID input method, refer to Section 3.6, “Entering ID”. 10 OER-Elite OPERATION MANUAL Important Information — Please Read Before Use User qualifications The operator of this reprocessor must be sufficiently trained in reprocessing of endoscopes. The medical literature reports cases of infections due to inappropriate cleaning, disinfection, and /or sterilization. Thoroughly review and understand the following items before use: Cleaning, disinfection, and sterilization procedures described in the instruction manuals for the endoscope and ancillary equipment. Professional health and safety standards. Applicable guidelines on cleaning, disinfection, and sterilization of endoscopy equipment. Structure and handling of endoscopic equipment. Personal protective equipment requirements to minimize exposure to chemicals and infectious materials. These manuals do not explain or discuss detailed cleaning, disinfection, and sterilization procedures. For more details, consult your facility’s procedures, professional guidelines, and regulatory requirements for reprocessing endoscopes. OER-Elite OPERATION MANUAL 11 Important Information — Please Read Before Use Ensuring the safety of reprocessing personnel • Disinfectant solution and detergent may irritate the mucous membranes in the eyes and respiratory organs. If disinfectant solution contacts the skin directly and eyes, it may cause irritation or damage. Therefore, before handling high-level disinfectant solution and detergent, carefully read the instructions for use and the safety data sheet. For further details, contact Olympus. • While using chemicals, wear appropriate personal protective gear to prevent contact with or inhalation of chemicals or infectious substances. Personal protective gear includes eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed. All personal protective gear should be inspected before use and replaced periodically before it is damaged. • When using disinfectant solution and alcohol, Olympus recommends the use of gas filters and running this reprocessor in well-ventilated areas. Wear a face mask, gloves, and protective clothes to minimize aspiration and skin contact. Wear goggles for eye protection. Refer to the following association’s guidelines related to ventilation: SGNA (Society of Gastroenterology Nurses and Associates) ASGE (American Society of Gastroenterological Endoscopy) APIC (Association for Professionals of Infection Control and Epidemiology) AORN (Association of Preoperative Registered Nurses) ASTM (American Society for Testing and Materials) OSHA (Occupational Safety and Health Administration) ACGIH (American Conference of Governmental Industrial Hygienists) NIOSH (National Institute for Occupational Safety and Health) AIA (American Institute of Architects) If the person operating the reprocessor exhibits an allergic reaction or symptoms, no matter how slight, they should discontinue the task they are performing and vacate the room. • Before handling the detergent or disinfectant, read the SDS (material safety data sheets) and learn what measures to take in the event of exposure. • Operators who exhibit symptoms of an allergic reaction or sensitivity to the reprocessing chemicals should not operate this reprocessor. • This reprocessor can be set up to use the RFID (Radio Frequency Identification) function. Be aware that the radio waves emitted from the RFID reader of the reprocessor may cause medical devices such as pacemakers to malfunction. If any interference with the equipment is found, immediately move away from the RFID reader or set the power switch to OFF. Contact a medical professional immediately if symptoms persist. 12 OER-Elite OPERATION MANUAL Important Information — Please Read Before Use Equipment compatibility Use the OER-Elite in combination with ancillary equipment listed in “System chart” on page 647. Using incompatible equipment may result in patient or operator injury and equipment damage and/or malfunction. Olympus has not tested the efficacy of reprocessing on the OER-Elite in combination with endoscopes that are not listed on the “List of compatible Endoscopes/Connecting Tubes ”. If using endoscopes that are not listed on the “List of compatible Endoscopes/Connecting Tubes ”, reprocessing of endoscopes may be insufficient. Care and storage After use, reprocess and store this reprocessor referring to the instructions in Chapter 10, “End-of-Day Checks” in this manual. Inappropriate care and storage could present an infection control risk and/or cause reprocessor damage or malfunction. Maintenance and Inspection • The OER-Elite requires routine maintenance and inspection. In addition to checks before use, the person in charge of maintenance and administration of the medical equipment at the facility should periodically check all of the items described in this manual. If any irregularity is found, do not use the reprocessor and inspect it as described in Section 13.2, “Troubleshooting guide”. If the irregularity is still present, the reprocessor must be repaired prior to next use. • If the PERIODIC MAINTENANCE indicator starts to indicate on the touch screen, described in Section 2.7, “Control panels”, the time for regularly scheduled maintenance is near. Contact Olympus to perform the maintenance. Repair and modification Do not disassemble, modify, or attempt to repair this reprocessor and its accessories. Doing so could result in operator or patient injury and/or equipment damage or malfunction. Some problems that appear to be malfunctions may be corrected by referring to Chapter 13, “Troubleshooting and Repair”. If the problem cannot be resolved using the information in Chapter 13, “Troubleshooting and Repair”, contact Olympus. OER-Elite OPERATION MANUAL 13 Important Information — Please Read Before Use Disposal of disinfectant solution Expired disinfectant solution for this reprocessor should be handled as directed in the Olympus-validated disinfectant product label and instructions. Follow all applicable national, state, and local guidelines. Disposal of this reprocessor When disposing of this reprocessor and accessories, follow all applicable national, state, and local regulations and guidelines. Signal words The following signal words are used throughout these manuals: WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage. NOTE Indicates additional helpful information. Warnings and cautions Follow the warnings and cautions given below when handling this reprocessor. This information is supplemented by warnings given in each chapter. WARNING • Do not insert an EndoTherapy accessory or other object through an opening including the air vent of the reprocessor. • Do not allow any liquid (including water or disinfectant solution) to flow into an opening. Contact with an electrical part inside the reprocessor could cause an electric shock or reprocessor failure. • Always remove the tank from the detergent/alcohol drawer before putting detergent or alcohol in the tank. If detergent or alcohol is spilled on the detergent/alcohol drawer, it could get inside the reprocessor and contact an electrical part inside, causing an electric shock or fire hazard. 14 OER-Elite OPERATION MANUAL Important Information — Please Read Before Use WARNING • Do not install this reprocessor in any place where any of the following are present. High oxygen concentration Oxidizing substance such as Nitrous Oxide (N2O) Flammable anesthetic gas This reprocessor is not explosion-proof and may explode or cause a fire under these conditions. • Always use the power cord provided with this reprocessor. Otherwise, reprocessor failure or power cord burnout may result. Also, remember that the provided power cord is for use only with this reprocessor and should not be used with any other equipment. CAUTION • Do not press any of the switches on the control panel of this reprocessor with a pointed or hard object. Otherwise, the switch may be damaged. • Be sure to turn off the water faucet and the power switch of the reprocessor at the end of the day to avoid potential water leaks. • To avoid malfunctions, do not use this reprocessor in a dusty environment. • To avoid electromagnetic interference from other equipment, do not install any other electrical devices in close proximity to this reprocessor (aside from ancillary devices used with this reprocessor). • This equipment enables radio communication by RFID and emits RF (radio frequency: 13.56 MHz) energy to perform the said intended functions. It may cause electromagnetic interference in nearby electronic equipment, and is labeled with the symbol below. If electromagnetic interference occurs, mitigation measures may be necessary, such as moving the electronic equipment away, reorienting or relocating this instrument, or shielding the location. An electromagnetic interference with other devices may shorten the communications distance of the designated ID tag and cause signals to become unreadable. Try to take mitigation measures such as keeping the affecting device away from this equipment. OER-Elite OPERATION MANUAL 15 Outline of Functions Outline of Functions Following functions are available in this reprocessor. Reprocessing A series of operations that enable the reprocessor to perform ultrasonic cleaning, detergent cleaning, disinfection, rinse, air purge, and alcohol flush. A series of operations for ultrasonic cleaning, detergent cleaning, disinfection, rinse, air purge, and alcohol flush of the outer surface and channels of endoscopes in a specified sequence and for a specified time. Reprocessing programs [1] to [4] can be selected by the user. Programs [1] to [4] have a fixed cleaning process time and disinfection process time. They also have different patterns of auto leak test and channel monitoring respectively. For details, refer to Chapter 6, “Reprocessing Operations”. Heat LCG A process for heating disinfectant solution until it reaches the specified temperature (22q, 72qF). This process is performed automatically during the reprocessing program. It can also be performed as an independent operation. For details, refer to Section 7.2, “Heat LCG”. Heat LCG Timer The function for heating the disinfectant solution until the specified temperature (22q, 72qF) by the specified time. For details, refer to Section 7.3, “Heat LCG Timer”. Drain LCG This function drains the disinfectant solution from the disinfectant tank. For details, refer to Section 8.2, “Replacing the disinfectant solution”. Load LCG This function loads the disinfectant solution after inserting a new disinfectant bottle. For details, refer to Section 8.2, “Replacing the disinfectant solution”. Mix LCG This function mixs the disinfectant solution to the appropriate concentration and enables accurate concentration check. 16 OER-Elite OPERATION MANUAL Outline of Functions Water line disinfection This function disinfects the water supply line and other lines inside the reprocessor. For details, refer to Section 7.7, “Water line disinfection”. Self disinfection and water sampling This function disinfects the basin and internal piping of the reprocessor. End of the process, sampling of rinse water can be performed for microbiological surveillance. For details, refer to Section 7.8, “Self-disinfection and water sampling”. Detergent/Alcohol line disinfection This function disinfects the detergent line and alcohol line of the reprocessor. For details, refer to Section 7.9, “Detergent line disinfection” and Section 7.10, “Alcohol line disinfection”. Auto leak test The endoscope leak test can be executed automatically by programming it in a user-configured reprocessing process. It can also be performed as an independent operation. For details, refer to Section 7.12, “Auto leak test”. Manual leak test Manual inspection for endoscope leakage during immersion of water can be performed as an independent operation. For details, refer to Section 7.11, “Manual leak test”. Alcohol flush To assist in drying the channel after reprocessing, alcohol is flushed through the endoscope channels followed by air. This function performs alcohol flush into the endoscope channels. The alcohol flush can be executed automatically in a reprocessing process. It can also be performed as an independent operation. For details, refer to Section 7.14, “Alcohol flush”. Air purge This function drains the remaining fluid from the basin after an irregularity occurs, or if the process is stopped before it completes. Air purge also eliminates residual fluid from the endoscope channels. For details, refer to Section 7.6, “Air purge”. OER-Elite OPERATION MANUAL 17 Outline of Functions Rinse This function performs the rinsing process if the fluid remains in the basin or in the endoscopes after an irregularity occurs or the process is stopped midway. For details, refer to Section 7.5, “Rinse”. Leaking scope decontamination This function decontaminates a leaking endoscope prior to repair. During the decontamination, positive pressure is applied to the leaking endoscope to avoid fluid invasion and damage to the endoscope. For details, refer to Section 7.15, “Leaking scope decontamination”. ALT self-check This function checks the auto leak test function of the reprocessor. It is performed automatically at the end of Load LCG function or as an independent operation. For details, refer to Section 7.13, “Self-check of auto leak test”. 18 OER-Elite OPERATION MANUAL 1.1 Checking the package contents Chapter 1 Checking the Package Contents Ch.1 1.1 Checking the package contents Check that the package contains all the items listed below. Inspect each item for damage. If the device is damaged, a component is missing, or there is any question regarding items, do not use the device and contact Olympus immediately. Endoscope reprocessor Endoscope reprocessor OER-Elite Accessories for use in installation Buckling guard (GT970400) Buckling guard retaining screw (GC783700, 2 pcs) Grommet (GC784100, 4 pcs) Wrench (GC748400) Drain hose (GJ853400) Water supply hose (GC416500) Power cord (RL545000) Water supply plug (GN573800) OER-Elite OPERATION MANUAL 19 1.1 Checking the package contents Accessories for use in reprocessing Ch.1 Connecting tube (MAJ-2110, 2 pcs) Connecting tube (MAJ-2111, 2 pcs) Connecting tube (MAJ-2112, 2 pcs) Connecting tube (MAJ-2113, 2 pcs) Leak test air tube (MAJ-2127, 2 pcs) Accessories to be attached to the reprocessor Gas filter case (GJ460700) Gas filter (2 pcs) (MAJ-822) Gas filter adapter (splash guard) (GC949900) Washing case (MAJ-2121) Air filter (MAJ-823) Water filter (MAJ-824 or MAJ-2318) Stylus pen holder (RA016500) Hex wrench (GT804300) M4 × 10 mm cap bolt (2 pcs) Stylus pen (GT944200) 20 OER-Elite OPERATION MANUAL 1.1 Checking the package contents Accessories preattached to the reprocessor Ch.1 Alcohol tank (RU715000) Circulation port mesh filter (GC574000 and GC693900) Retaining rack (GT943000) Detergent/alcohol inner tray (GT647800) Drain port mesh filter (GC220100) Gas filter case (GJ460700) Water tray (GT949200) Accessories for use in maintenance Syringe (GT173600) Tube (GC651300) Disinfectant collection hose (GJ668000) Disinfectant removal tube (GJ460200) Filter tube (GJ460500, 2 pcs) Water filter wrench (GC601300) Drain connector (GL366300) Connector jig (RU726500) Spare fuse (DB181500, 2 pcs) Water supply piping disinfection hose (RU205800) Card holder (GT271000, 2 pcs) OER-Elite OPERATION MANUAL 21 1.1 Checking the package contents Ch.1 Scope ID master card (GT970700) User ID master card (GT970600) Accessory for use in record management Portable memory (MAJ-1925) Manuals Instructions-Installation Manual Instructions-Operation Manual (this manual) OER-Elite Quick Reference Guide OER-Elite Operation Guide 22 OER-Elite OPERATION MANUAL List of Compatible Endoscopes/Connecting Tubes 2.1 Front panel Chapter 2 2.1 Nomenclature and Functions Front panel Ch.2 11 10 No. Nomenclature Description Power switch Press to turn the reprocessor ON or OFF. Power indicator Lights up when the reprocessor is ON. Disinfectant bottle drawer Accommodates disinfectant cassette bottles. This door can be opened when the load LCG function is started. Disinfectant bottle drawer check windows Check an inside of bottles in the disinfectant bottle drawer. Casters The two front casters have lock mechanisms. The caster heights can be adjusted to level the reprocessor. Foot pedal Step to open the lid. It is locked during the reprocessing process. Front door Push the area marked “PUSH” to open. Alcohol tank check window Checks the amount of alcohol remaining. Detergent tank check window Checks the amount of detergent remaining. 10 Detergent/alcohol drawer Accommodates the specially designed tanks of detergent for cleaning and alcohol for alcohol flush. 11 Portable memory port Insert the portable memory into this port. OER-Elite OPERATION MANUAL 23 2.2 Top panel 2.2 Top panel Ch.2 No. Nomenclature Description Water supply hose Supplies water for use in cleaning. Water supply hose connector Connect the water supply hose. A mesh filter is built in this connector. Lid Step on the foot pedal to open the lid. Control panel Used for various setup and operation. Refer to Section 2.7, “Control panel”. RFID reader Reads RFID tag for user ID, scope ID, and physician ID. Gas filter case (lid) Accommodates the gas filter which removes the odor and vapor of the disinfectant solution. Ventilation openings on the These are the slots for intake and exhaust of air into/from the reprocessing basin. gas filter case Do not block the ventilation openings on the gas filter case. 24 OER-Elite OPERATION MANUAL 2.3 Inside 2.3 Inside Ch.2 11 10 No. Nomenclature Description Gas filter case (tank) Accommodates the gas filter which removes the odor and vapor of the disinfectant solution. Ventilation opening on the gas filter case These are the slots for intake and exhaust of air into/from the disinfectant solution tank. Do not block the ventilation openings on the gas filter cases. Disinfectant solution tank window Used to check the amount of remaining disinfectant solution. Accessory holder Used to store the connecting tubes, etc. Disinfectant removal port Used to remove the residual disinfectant solution in the tank by using the disinfectant removal tube. It is also used to withdraw the amount of disinfectant solution by using the drain connector for detergent/alcohol piping disinfection. (Remove the rubber cap and attach the drain connector or the disinfectant removal tube.) Maintenance terminal Used for connecting ancillary equipment (for trained service personnel only). Water tray Collects water during maintenance such as the water filter replacement. Air filter Accommodates the 0.2-micron air filter. Connector below water filter housing For use in draining water from the water filter housing. 10 Water filter (housing) Accommodates the 0.2-micron internal water filter. 11 Connector above water filter housing For use in draining water and air from the water filter housing. OER-Elite OPERATION MANUAL 25 2.4 Rear panel 2.4 Rear panel Ch.2 No. Nomenclature Description Printer outlet Connect the power cord of the printer (MAJ-1937) provided with the optional printer set (MAJ-2144) to feed power to it. Do not connect any devices other than the specified printer. Bar code reader port Connect the optional bar code reader (MAJ-2130). Do not connect any devices other than the specified bar code reader. Fuse (BOX) Protects the reprocessor from an over-current. Power cord receptacle Connect the power cord. 100BASE-TX terminal Used to access the Olympus-designated external devices (for trained service personnel only). Printer communication port Connects the printer (MAJ-1937) provided with the optional printer set (MAJ-2144). Do not connect any devices other than the specified printer. Buckling guard attaching holes Screw holes used to attach the buckling guard. Drain hose connector Connect the drain hose. 26 OER-Elite OPERATION MANUAL 2.5 Side panel 2.5 Side panel Ch.2 Left Right No. Nomenclature Description Bar code reader attaching holes Used to attach the optional bar code reader (MAJ-2130). Printer set attaching holes Used to attach the optional printer set (MAJ-2144). The connector hanger cannot be attached if the printer set is already attached. Stylus pen holder attaching Used to attach the provided stylus pen holder. holes Connector hanger attaching holes Used to attach the optional connector hanger (MAJ-865). The printer set cannot be attached if the connector hanger is already attached. Grommet attaching holes (×4) Used to attach the grommets. OER-Elite OPERATION MANUAL 27 2.6 Reprocessing basin 2.6 Reprocessing basin Ch.2 22 19 21 20 18 17 16 10 11 15 12 14 13 23 28 OER-Elite OPERATION MANUAL 2.6 Reprocessing basin No. Nomenclature Description Connector A2 (Light blue) Connect a connecting tube colored light blue. This connector is mainly used for second endoscope. Connector B2 (Blue) Connect a connecting tube colored blue. This connector is mainly used for second endoscope. Connector B1 (Blue) Connect a connecting tube colored blue. This connector is mainly used for first endoscope. Connector A1 (Light blue) Connect a connecting tube colored light blue. This connector is mainly used for first endoscope. Connector D2 (Orange) Connect a connecting tube colored orange. This connector is mainly used for second endoscope. Connector C2 (Green) Connect a connecting tube colored green. This connector is mainly used for second endoscope. Connector C1 (Green) Connect a connecting tube colored green. This connector is mainly used for first endoscope. Connector D1 (Orange) Connect a connecting tube colored orange. This connector is mainly used for first endoscope. Circulation port Aspirates the cleaning fluid or disinfectant solution for circulation during cleaning or disinfection. 10 Drain port Drains liquid from the reprocessing basin. 11 Leak test connector E2 (Purple) Connect the leak test air tube that is connected to the second endoscope here. 12 Leak test connector E1 (Purple) Connect the leak test air tube that is connected to the first endoscope here. 13 Washing case mount Mount for the Washing case that is used to hold the endoscope accessories including valves for reprocessing. 14 Temperature sensor Monitor the temperature of the fluid in the reprocessing basin. 15 Water supply piping disinfection connector Connect the water supply piping disinfection hose here. 16 Fluid level sensor Detects abnormal fluid level in the reprocessing basin. 17 Disinfectant solution nozzle Supplies disinfectant solution to the reprocessing basin. Also, used to check if the disinfectant concentration meets the recommended level by the disinfectant manufacturer. (Open the cap and insert the chemical indicator (test strip).) 18 Float switch (long) Detects the fluid level in the reprocessing basin to control it. 19 Detergent nozzle Supplies detergent to the reprocessing basin. 20 Float switch (short) Detects the fluid level in the reprocessing basin to control it. 21 Circulation nozzle Supplies the cleaning fluid or disinfectant solution aspirated through the circulation port for circulation. 22 Water supply/circulation nozzle Supplies water for cleaning. Also, supplies the cleaning fluid or disinfectant solution aspirated through the circulation port for circulation. 23 Water level scale (× 3) Marks for confirming that the reprocessor is level. OER-Elite OPERATION MANUAL Ch.2 29 2.7 Control panels 2.7 Control panels Ch.2 No. Nomenclature Description Touch screen Used to control and set the reprocessor. Also, the information and state of the reprocessor can be displayed. Heat LCG Timer indicator The indicator lights when the Heat LCG Timer is in progress. Heat LCG Timer button Press this button to active the Heat LCG Timer. Stop button Press this button to stop process. Start button Press this button to start process. 30 OER-Elite OPERATION MANUAL 2.8 Consumable accessories (Optional) 2.8 Consumable accessories (Optional) WARNING Before using consumable items, be sure to check its shelf-life and expiration date items. If these items are expired, effectiveness of items may be compromised. Water filter (MAJ-824 or MAJ-2318) Internal 0.2 micron water filter. Internal 0.2 micron water filter. Figure 2.1 Gas filters (MAJ-822) Inserted in the gas filter cases to absorb disinfectant odors and vapors. Figure 2.2 OER-Elite OPERATION MANUAL 31 Ch.2 2.8 Consumable accessories (Optional) Air filter (MAJ-823) Ch.2 Filters microorganisms and fine particles in the air fed into the reprocessor. Figure 2.3 Olympus-validated detergent Figure 2.4 Name Type Manufacturer Remarks EndoQuick Alkaline detergent Best Sanitizers, Inc. (154 Mullen Drive, Walton, KY) 2.8 L disposable tank Table 2.1 NOTE EndoQuick is distributed by Olympus America, Inc. To obtain EndoQuick listed above, contact Olympus. 32 OER-Elite OPERATION MANUAL 2.8 Consumable accessories (Optional) Olympus-validated concentrated disinfectant solution (1,065 ml cassette bottles) Ch.2 Figure 2.5 Name Type Manufacturer Remarks 510(k) number Acecide-C Peracetic Acid (PAA) Best Sanitizers, Inc. (154 Mullen Drive, Walton, KY) 1,065 ml cassette bottles For use in OER-Elite K091210 Table 2.2 NOTE Acecide-C is distributed by Olympus America, Inc. To obtain Acecide-C listed above, contact Olympus. OER-Elite OPERATION MANUAL 33 2.8 Consumable accessories (Optional) Chemical indicator (test strip) FDA-cleared Chemical indicator (test strip) used to determine if Olympus-validated disinfectant meets the minimum recommended concentration. Ch.2 Figure 2.6 Name Manufacturer 510(k) number ACECIDE test strips Best Sanitizers, Inc. (154 Mullen Drive, Walton, KY) K091210 Table 2.3 NOTE ACECIDE test strips is distributed by Olympus America, Inc. To obtain ACECIDE test strips listed above, contact Olympus. 34 OER-Elite OPERATION MANUAL 3.1 Turning power ON Chapter 3 3.1 Basic Operation Turning power ON Press the power switch of the reprocessor. Ch.3 Figure 3.1 CAUTION Connect the connection ring on the reprocessor end of the water supply hose to the water supply hose connection port by tightening securely. An insecure connection may lead to a risk of a water leak. For detail, refer to Section 4.4 “Connection of the water supply hose” in “Instructions-Installation Manual”. NOTE Lighting of Heat LCG Timer indicator means that Heat LCG Timer is being activated. For the operation during running of the Heat LCG Timer, refer to Section 7.3, “Heat LCG Timer”. Heat LCG Timer indicator Figure 3.2 OER-Elite OPERATION MANUAL 35 3.1 Turning power ON The power indicator lights up and the touch screen displays the initial screen for few seconds. Initial screen Ch.3 Figure 3.3 The Start screen appears. Start screen will display the Menu screen or Reprocess standby screen. Menu screen Reprocessing Standby screen Figure 3.4 NOTE • The Start Screen is set to “Menu screen” at the factory. For how to set the Reprocessing Standby screen, refer to Section 4.18, “Start screen”. • Before using the reprocessor, always show the confirmation information. Refer to Figure 3.5. Figure 3.5 36 OER-Elite OPERATION MANUAL 3.2 Alarm indicator 3.2 Alarm indicator When the timing of periodical maintenance comes, the number of usage days or cycles of a consumable item reaches the set value, shelf-life of the item expires or the network setting is activated, the alarm indicator displays on the top right of the touch screen. Alarm indicator information button Ch.3 Communication status indicator Filter replacement indicator Detergent replacement indicator Disinfectant solution replacement indicator Periodic maintenance indicator Figure 3.6 Periodic maintenance indicator If the PERIODIC MAINTENANCE indicator starts to indicate on the touch screen, “Control panels”, the time for regularly scheduled maintenance is near. Contact Olympus to perform the maintenance. If you do not know when the indicator started to light, do not use the reprocessor and contact Olympus. Otherwise, the reprocessing may be insufficient. OER-Elite OPERATION MANUAL 37 3.2 Alarm indicator Disinfectant replacement indicator The indicator lights when the following reaches set value. • The number of days of disinfectant usage • The number of cycle count of disinfectant usage • The number of day of shelf-life reaches For how to set the disinfectant solution counter, refer to Section 4.12, “LCG replacement indicator”. For how to set the shelf-life, refer to Section 4.13, “LCG lot number and shelf-life management”. Ch.3 WARNING Be sure to check the concentration of the disinfectant solution by using the separately available test strips. The disinfectant replacement indicator does not determine the effectiveness of the disinfectant solution. The expiration of the disinfectant solution varies depending on many factors including the time since activation, the temperature of the environment where the reprocessor is installed, and the number and types of endoscopes that have been reprocessed. The disinfectant replacement indicator does not take these and other factors into consideration. Detergent replacement indicator The indicator lights when the following reaches set value. • The number of days of detergent usage • The number of day of shelf-life reaches For details on the setting change, refer to Section 4.10, “Detergent replacement indicator”. For how to set the shelf-life, refer to Section 4.11, “Detergent lot number and shelf-life management”. Filter replacement indicator The lamp light when the number of days of filter usage reaches set value. The number of days of water filter usage. The number of days of air filter usage. The number of days of gas filter (lid) usage. The number of days of gas filter (tank) usage. For details on the setting change, refer to Section 4.14, “Filter replacement indicator”. 38 OER-Elite OPERATION MANUAL 3.2 Alarm indicator Communication status indicator This indicator shows the network status of the reprocessor. The network function setting and connection status can be confirmed depending on the type of indicator. When the non-connected status is displayed (yellow indicator), the reprocessor is not connected to a network. Check the power supply to the external devices and the connection between the external devices and the OER-Elite. If the problem cannot be resolved, contact Olympus. Indicator Description green Communication is established. yellow Communication is interrupted. Not displayed Communication setting is OFF. Ch.3 Table 3.1 Alarm indicator information button Press the button to view the information about the displayed alarm indicator. When no alarm indicator is displayed When alarm indicators are displayed Figure 3.7 NOTE • If the network function is disabled, the information screen does not show information on the network. • The information screen shows only the explanations of the warnings indicated by the displayed alarm indicator. OER-Elite OPERATION MANUAL 39 3.3 Control panel operation 3.3 Control panel operation This reprocessor employs a touch screen control panel. The touch screen should be manipulated by pressing with a finger of the operator or touching with the provided stylus pen. Ch.3 Pressing with a finger of the operator. Figure 3.8 40 OER-Elite OPERATION MANUAL Touching with the provided stylus pen. 3.4 Menu screen 3.4 Menu screen In the menu screen, there are six buttons. Select the desired category here. No. Button Ch.3 Description Reprocessing Press this button to display the Reprocessing Standby screen. oRefer to Section 6.5, “Basic operation for reprocessing”. Functions Press this button to go to Functions menu. oRefer to Section 7.1, “Function menu”. Replacement of Consumable Items Press this button to go to Replacement of Consumable Items menu. oRefer to Section 8.1, “Replacement of consumable items menu”. Log Press this button to go to Log menu. oRefer to Section 11.1, “Log menu”. Settings Press this button to go to Setting menu. oRefer to Section 4.1, “Setting menu”. Information Press this button to go to Information menu. oRefer to Chapter 12, “Information Menu Screen”. NOTE The operational buttons are expressed by a box with gradation. Figure 3.9 OER-Elite OPERATION MANUAL 41 3.5 LCG Info. screen 3.5 LCG Info. screen This reprocessor can display the information on the disinfectant solution including the temperature and usage count. Press the “Reprocessing” button on the touch screen. Ch.3 Figure 3.10 Press the “LCG Info.” button on the touch screen. Figure 3.11 42 The LCG Info. screen pops up. OER-Elite OPERATION MANUAL 3.5 LCG Info. screen Ch.3 No. Item/Button Description Latest MRC Check Result Information on the latest MRC check result. LCG Cycle Count Usage count of the current disinfectant solution. When this setting is activated, the reprocessor counts the number after each process that uses the disinfectant solution (e.g. reprocessing, water line disinfection or leaking scope decontamination) is performed. LCG Usage Number of days the current disinfectant solution has been used. LCG Temp. Current temperature of the disinfectant solution. MRC Check Result Opens the MRC check result input screen. OK Closes the LCG Info. screen. OER-Elite OPERATION MANUAL 43 3.6 Entering ID 3.6 Entering ID Five kinds of IDs can be input, including the scope ID, user ID, physician ID, patient ID and procedure ID. The IDs can be input with one of the following four methods. The input methods are variable depending on the types of IDs. Input through the RFID reader built into the reprocessor. Input from the software keyboard displayed on the touch screen. Ch.3 Recalling ID information registered in advance (Recalling the pre-registered ID). Input using the optional MAJ-2130 bar code reader. RFID reader Software keyboard Recalling the pre-registered ID Optional bar code reader Scope ID – User ID – Physician ID – Patient ID – Procedure ID – Possible – – – Impossible NOTE • If the scope ID is input by using the scope ID master card, input by the software keyboard or input by recalling the pre-registered ID, the “Auto leak test” and “Channel Monitoring” are disabled. • When reprocessing endoscope and accessories with no ID tag such as ultrasonic probes, enter the master ID as the scope ID. If the master ID is entered as the scope ID, “N/A” is entered as physician, patient and procedure IDs. • Do not use anything other than the designated ID tag/chip. Otherwise correct data will not be inputted. 44 OER-Elite OPERATION MANUAL 3.6 Entering ID Entering through the RFID reader WARNING Be aware that the radio waves emitted from the RFID reader of the reprocessor may cause medical devices such as pacemakers to malfunction. If any interference with the equipment is observed, immediately move away from the RFID reader or set the power switch to OFF. Call your doctor if you do not begin to feel better. Ch.3 CAUTION Electromagnetic interference with other devices may reduce the communication distance of the designated ID tag and cause signals to become unreadable. Try to take mitigation measures such as keeping other radio frequency emitting or other energy emitting devices, such as electrosurgical units, away from this reprocessor. Perform the following operations on a screen that requests an ID input such as the Reprocessing Standby screen. OER-Elite OPERATION MANUAL 45 3.6 Entering ID Scope ID entry Press the “Reprocessing” button on the Menu Screen. Hold the internal ID endoscope connector or the external ID tag near the RFID reader on the OER-Elite. A short beep will indicate the tag was read successfully. Ch.3 For internal ID endoscope (For example 180 series endoscope) For external ID tag Scope ID mark For internal ID endoscope (190 series endoscope 1) 1 190 series endoscopes may not be available in some areas. Figure 3.12 If the connection guide display setting is activated, when the ID has been read, the following screen appears. Figure 3.13 46 OER-Elite OPERATION MANUAL 3.6 Entering ID User or physician ID entry Press the “Reprocessing” button on the Menu screen. Hold the user or physician ID card parallel with the ID reader section and approach it until a short beep is generated. Ch.3 Figure 3.14 When the ID has been read, the following screen appears. The information on the input ID is displayed. Figure 3.15 NOTE The user ID (load) and physician ID of second endoscope can be read after reading the ID of second endoscope. OER-Elite OPERATION MANUAL 47 3.6 Entering ID Entering by the software keyboard An ID can be entered by the software keyboard (on-screen) on the touch screen as described below. If it is during the reprocessing process, press or button on the Reprocessing Standby screen. If it is during the leaking scope decontamination, press button on the ID input screen. Ch.3 Reprocessing Leaking scope decontamination Figure 3.16 Then, the ID select screen is displayed. No. Button Note “Edit” button of scope ID Opens the scope ID list. “Edit” button of patient ID Opens the patient ID list. “Edit” button of physician ID Opens the physician ID list. “Edit” button of user ID (load) Opens the user ID (load) list. “Edit” button of procedure ID Opens the procedure ID list. 48 OER-Elite OPERATION MANUAL 3.6 Entering ID NOTE • When scope ID is entered using the software keyboard, the auto leak test and channel blockage monitoring functions will not be available. In the manual leak test function, the scope ID can be entered by the software keyboard. To enter the scope ID, Press the “Edit” button during the manual leak test. Then, refer to step 2 in “ Scope ID entry” on page 49. • In the auto leak test function, the scope ID cannot be entered by the software keyboard (on-screen). RFID of the endoscope is necessary to perform the auto leak test. • When User ID setting of Reprocessing (end of reprocessing) is activated, the user ID can be entered by the software keyboard (on-screen) at the end of reprocessing. To enter the user ID, press the “Edit” button at the end of reprocessing. Then, refer to Step 2 in “ Physician ID, user ID, or procedure ID entry” on page 59. For details of User ID setting, refer to Section 4.5, “User ID Setting”. • When user ID setting of “Functions & Replacement of Consumable Items” is activated, the user ID can be entered by the software keyboard (on-screen) before starting each function or replacement. To enter the user ID, Press the “Edit” button during each function or replacement. Then, refer to Step 2 in “ Physician ID, user ID, or procedure ID entry” on page 59. For details of User ID setting, refer to Section 4.5, “User ID Setting”. Scope ID entry Press the “Edit” button of scope ID on the ID select screen. Figure 3.17 OER-Elite OPERATION MANUAL 49 Ch.3 3.6 Entering ID Then the scope ID list is displayed. When the Scope ID is not listed on the ID list, go to “(a) Select a Scope ID that is not listed” on page 51. When the Scope ID is listed on the ID list, go to “(b) Recalling the pre-registered ID” on page 54. Ch.3 No. Item/Button Note ID type Type of the currently edited ID. Model # Registered model number of the endoscope. These areas are blank if no ID has been registered. Serial # Registered serial number of the endoscope. These areas are blank if no ID has been registered. Edit Press one of the buttons to open the ID information edit screen. Set Press one of the buttons to set a registered ID. Previous page button Press to return to the previous page. When there is no further page to turn back to, the button turns gray and becomes unavailable. Next page button Press to go to the next page. When there is no further page to go forward to, the button turns gray and becomes unavailable. Back Press to close the ID select screen. 50 OER-Elite OPERATION MANUAL 3.6 Entering ID (a) Select a Scope ID that is not listed To set a new scope ID, press the “Edit” button that no ID has been registered. To change the registered Scope ID, press the “Edit” button of the Scope ID. Ch.3 Figure 3.18 The software keyboard (on-screen) is opened. Enter the model number of the endoscope on the software keyboard. Alphabet input Numeral input No. Button Note Alphabet/ Numeral key Enter an alphabet or a numeral. Uppercase/ Lowercase Press “Uppercase/lowercase” button to switch alphabet character on the software keyboard (on-screen) between uppercase characters and lowercase characters. Numeric/ Alphabetic Press “Numeric or Alphabetic” button to switch the input mode between a numeral and the alphabet. Backspace Press the “Backspace” button to delete the left character of a cursor. When a cursor is on the left edge, this button turns gray and becomes unavailable. Space Press the “Space” button to insert a space character. Cursor move Press the “Cursor move” button to move the cursor left or right. Delete Press the “Delete” button to delete about all information. Cancel Return to the previous screen without saving the setting value. Save Return to the previous screen and save the entered value. OER-Elite OPERATION MANUAL 51 3.6 Entering ID Press the “Serial #” button on the software keyboard. Ch.3 Figure 3.19 Enter the serial number of the endoscope. Press the “Save” button, then the scope ID was set to the reprocessing process. Figure 3.20 The connection information screen is displayed on the touch screen. Connect the suitable connecting tubes according to the “List of Compatible Endoscopes/Connecting Tubes ”, then press the “No Connection” buttons corresponding to the reprocessing basin connectors to which the connecting tubes are connected. The “No Connection” indicator will now change to “Connection”. Figure 3.21 52 OER-Elite OPERATION MANUAL 3.6 Entering ID Press the “OK” button. Ch.3 Figure 3.22 The following message is displayed. After reading the message, Press the “OK” button again. Figure 3.23 NOTE When the “Manual Cleaning and Leak Test Setting” is activated, select the manual cleaning and leak testing results after Step 7. For detail, refer to “ Input results of manual cleaning and leak test of second endoscope” on page 214. Once the scope ID is entered, the ID select screen appears. To go back to the reprocessing standby screen, press “OK” button. Figure 3.24 OER-Elite OPERATION MANUAL 53 3.6 Entering ID (b) Recalling the pre-registered ID NOTE • The ID edited on “(a) Select a Scope ID that is not listed” on page 51 is registered to the ID list. • The ID list can be edited on the list management function. For detail, refer to Section 12.3, “List management”. Ch.3 Press the “Set” button for the ID to be recalled. Figure 3.25 On the Connection information screen, Press the “No Connection” buttons corresponding to the reprocessing basin connectors to which the connecting tubes are connected. The “No Connection” indicator will now change to “Connection”. Figure 3.26 54 OER-Elite OPERATION MANUAL 3.6 Entering ID Press the “OK” button. Ch.3 Figure 3.27 The following message is displayed. After reading the message, Press the “OK” button again. Figure 3.28 NOTE When the “Manual Cleaning and Leak Test Setting” is activated, select the manual cleaning and leak testing results after Step 4. For detail, refer to “ Input results of manual cleaning and leak test of second endoscope” on page 214. When the scope ID is completed to enter, the ID select screen appears. Figure 3.29 OER-Elite OPERATION MANUAL 55 3.6 Entering ID Patient ID entry NOTE When the patient ID setting is not activated, patient ID cannot be entered. Press the “Edit” button of the patient ID on the ID select screen. Ch.3 Figure 3.30 56 OER-Elite OPERATION MANUAL 3.6 Entering ID The software keyboard (on-screen) is opened. Enter the ID number of the patient on the software keyboard (on-screen). Alphabet input Numeral input Ch.3 No. Button Note Alphabet/ Numeral key Enter an alphabet or a numeral. Uppercase/ Lowercase Press “Uppercase/lowercase” button to switch alphabet character on the soft keyboard between uppercase characters and lowercase characters. Numeric/ Alphabetic Press “Numeric or Alphabetic” button to switch the input mode between a numeral and the alphabet. Backspace Press the “Backspace” button to delete the left character of a cursor. When a cursor is on the left edge, this button turns gray and becomes unavailable. Space button Press the “Space” button to insert a space character. Cursor move Press the cursor move button to move the cursor left or right. Name Press “Name or ID” button to switch the input mode between a Name and an ID. Cancel Return to the previous screen without saving the setting value. Save Return to the previous screen and save the entered value. Press the “Name” button. Figure 3.31 OER-Elite OPERATION MANUAL 57 3.6 Entering ID Enter the patient name. Ch.3 Figure 3.32 Press the “Save” button. Figure 3.33 When the patient ID is completed to enter, the following screen appears. Figure 3.34 58 OER-Elite OPERATION MANUAL 3.6 Entering ID Physician ID, user ID, or procedure ID entry Press the “Edit” button to enter each ID on the ID select screen. Ch.3 No. Button Note Edit physician ID button Opens the physician ID list. When the physician ID setting is not activated, item of the physician ID is not displayed. For physician ID setting, refer to Section 4.6, “Physician ID setting”. Edit user ID button Opens the user ID list. When the user ID setting is not activated, item of the user ID is not displayed. For user ID setting, refer to Section 4.5, “User ID Setting”. Edit procedure ID button Opens the procedure ID list. When the procedure ID setting is not activated, item of the procedure ID is not displayed. For procedure ID setting, refer to Section 4.9, “Procedure ID setting”. OER-Elite OPERATION MANUAL 59 3.6 Entering ID Then the ID list is displayed. When the ID is not listed on the ID list, go to “(a) Select each ID that is not listed” on page 61. When the Scope ID is listed on the ID list, go to “(b) Recalling the pre-registered ID” on page 63. Ch.3 No. Item/Button Note ID type Type of the currently edited ID. Name Name of the registered IDs. These areas are blank if no ID has been registered. ID ID number of registered IDs. These areas are blank if no ID has been registered. Edit buttons Press one of the buttons to open the ID information edit screen. Set buttons Press one of the buttons to set a registered ID. Previous page button Press to return to the previous page. When there is no further page to turn back to, the button turns gray and becomes unavailable. Next page button Press to go to the next page. When there is no further page to go forward to, the button turns gray and becomes unavailable. Back Press to close the ID select screen. 60 OER-Elite OPERATION MANUAL 3.6 Entering ID (a) Select each ID that is not listed Press the “Edit” button that no ID has been registered. Ch.3 Figure 3.35 The software keyboard (on-screen) is opened. Enter the ID number of the physician, user, or procedure on the software keyboard (on-screen). Alphabet input Numeral input No. Button Note Alphabet/ Numeral key Enter an alphabet or a numeral. Uppercase/ Lowercase Press “Uppercase/lowercase” button to switch alphabet character on the soft keyboard between uppercase characters and lowercase characters. Numeric/ Alphabetic Press “Numeric or Alphabetic” button to switch the input mode between a numeral and the alphabet. Backspace Press the “Backspace” button to delete the left character of a cursor. When a cursor is on the left edge, this button turns gray and becomes unavailable. Space Press the “Space” button to insert a space character. Cursor move Press the “Cursor move” button to move the cursor left or right. Delete Press the “Delete” button to delete about all information. Cancel Return to the previous screen without saving the setting value. Save Return to the previous screen and save the entered value. OER-Elite OPERATION MANUAL 61 3.6 Entering ID Press the “Name” button. Ch.3 Figure 3.36 Enter the physician, user, or procedure name. Figure 3.37 Press the “Save” button. Figure 3.38 62 OER-Elite OPERATION MANUAL 3.6 Entering ID When the ID is completed to enter, the following screen appears. Ch.3 Figure 3.39 (b) Recalling the pre-registered ID NOTE • The ID edited on “(a) Select each ID that is not listed” is registered to the ID list. • The ID list can be edited on the list management function. For detail, refer to Section 12.3 “List management”. Press the “Set” button for the ID to be recalled. Figure 3.40 When the ID is completed to enter, the following screen appears. Figure 3.41 OER-Elite OPERATION MANUAL 63 3.6 Entering ID Confirmation of the input ID Open the ID select screen. Confirm each ID information. 10 11 12 13 14 15 Ch.3 16 No. Item/Button Note View Scope ID information Displays the scope ID information (endoscope type and serial number). This area is blank when no scope ID has been input. Edit Scope ID button Opens the scope ID list to modify. Delete Scope ID button Deletes the input scope ID information. View Patient ID information Displays the patient ID information (patient name and ID number). This area is blank when no patient ID has been input. Edit Patient ID button Opens the patient ID list to modify. Delete Patient ID button Deletes the input patient ID information. View Physician ID information Displays the physician ID information (physician name and ID number). This area is blank when no physician ID has been input. Edit Physician ID button Opens the physician ID list to modify. Delete Physician ID button Deletes the input physician ID information. 10 View user ID information Displays the user ID (load) information (user name and ID number). This area is blank when no user ID has been input. 11 Edit user ID button Opens the user ID list to modify. 12 Delete user ID button Deletes the input user ID information. 13 View procedure ID information Displays the procedure ID information (procedure name and ID number). This area is blank when no procedure ID has been input. 14 Edit procedure ID button Opens the procedure ID list to modify. 15 Delete procedure ID button Deletes the input procedure ID information. 16 OK button 64 Returns to the Reprocessing standby screen. OER-Elite OPERATION MANUAL 3.6 Entering ID Entering the patient ID by the optional bar code To input the patient ID from a bar code, it is required to connect the optional MAJ-2130 bar code reader. For the installation of the bar code reader, refer to the Instructions - Installation Manual for this reprocessor and the Instructions for the MAJ-2130 bar code reader. CAUTION Do not connect anything other than the designated bar code reader to the bar code port. Otherwise, the IDs may not be read out correctly or the instrument may malfunction. NOTE • A patient ID can be input by either bar cord reader or software keyboard (on-screen), but a patient name can be input only by the software keyboard. It is possible to input the patient name by software keyboard (on-screen) after entering the patient ID by the bar code reader. • The OER-Elite can read the top 23 characters of each bar code. When the bar code contains data other than patient data, the reprocessor reads all of 23 characters including data other than the patient data that a bar code has. • Do not alter the settings of the bar code reader. It has been set to the optimum settings for combined use with this reprocessor. If the Settings are altered, it may be impossible to read the bar code, contact Olympus. OER-Elite OPERATION MANUAL 65 Ch.3 3.6 Entering ID Readable bar code standards The optional MAJ-2130 bar code reader can read below as a bar cord standards. UPC/EAN Code 128 GS1-128 Code 39 Trioptic Code 39 Code 93 Code 11 Interleaved 2 of 5 Discrete 2 of 5 Codabar MSI Chinese 2 of 5 Matrix 2 of 5 Korean 3 of 5 Inverse 1D GS1 DataBar Composite Codes Ch.3 66 OER-Elite OPERATION MANUAL 3.6 Entering ID Scanning area of the bar code reader When the bar code reader scans a bar code, the bar code reader projects a green aiming pattern. The scanning pattern of the bar code reader is formed by the aiming pattern. When the entire bar code does not cross the scanning pattern, the bar code reader cannot scan the entire bar code. For how to install the bar code reader (for example setting), refer to Figure 3.43. Bar code Aiming pattern Ch.3 Suitable examples Unsuitable examples Figure 3.42 Figure 3.43 OER-Elite OPERATION MANUAL 67 3.6 Entering ID Reading a bar code Press the “Reprocessing” button on the touch screen. Place the bar code under the bar code reader to read the bar code and adjust the distance between them so that the entire bar code is within the scanning area of the bar code reader. When the bar code reader succeeds in scanning of the bar code, the bar code reader sounds a short beep. If the bar code reader does not sound a short beep, correct problems in reference to the instruction manual for the bar code reader MAJ-2130 or Section 13.2, “Troubleshooting guide”. Ch.3 NOTE If the bar code reader does not sound a short beep, correct problems in reference to the instruction manual for the bar code reader MAJ-2130 and Section 13.2, “Troubleshooting guide”. The touch screen displays data scanning form bar code as shown in the following figure. Check if the patient ID matches the actual patient information. Screen of information on the input ID Figure 3.44 68 OER-Elite OPERATION MANUAL 3.7 Checking the MRC level and entering the check result 3.7 Checking the MRC level and entering the check result Before starting any of the following processes, be sure to check that the concentration of the disinfectant solution is no less than the Minimum Recommended Concentration (MRC). If the concentration is below the recommended minimum concentration or the shelf life of the disinfectant solution has expired, replace the disinfectant solution. The result of MRC can be recorded with the reprocessor. Ch.3 Reprocessing Leaking scope decontamination Water line disinfection Self-disinfection & Water sampling Detergent line disinfection Alcohol line disinfection WARNING • The use life of the disinfectant solution may vary depending on many factors, including storage conditions, and the temperature of the environment where the reprocessor is installed. Routinely check the concentration of the disinfectant solution with the test strip before performing endoscope disinfection. If this check is not performed, the disinfection process may be ineffective. Replace the disinfectant solution when it fails to meet the minimum recommended concentration or beyond the specified use life. • Before handling the disinfectant solution, read the SDS and instructions for use of the disinfectant solution carefully, get fully accustomed to the contents, and use the disinfectant solution as instructed. Be sure to fully understand what to do if the disinfectant solution comes in contact with your skin and eyes. • When handling the disinfectant solution, wear appropriate personal protective equipment. Avoid direct physical contact and inhalation of vapors. If any disinfectant solution gets in your eyes, immediately rinse with a large amount of fresh water and then consult a medical specialist. Personal protective equipment includes eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed. All personal protective equipment should be inspected before use and replaced periodically. If personal protective gear is damaged or defective in anyway, do not handle hazardous chemicals and refer to the facility policies. OER-Elite OPERATION MANUAL 69 3.7 Checking the MRC level and entering the check result Required items Check Required Items Chemical indicator (Test strip) Clean cloth Table 3.2 NOTE Ch.3 For the usable test strips, refer to Section 2.8, “Consumable accessories (Optional)”. Checking the MRC level WARNING Since the period of validity of the disinfectant solution varies depending on multiple factors including the storage condition and the environmental temperature of the reprocessor’s installation location, be sure to check the concentration of the disinfectant solution before reprocessing endoscopes. If the concentration is below the recommended minimum concentration or the validity date specified for the disinfectant solution has expired, replace the disinfectant solution. Otherwise, the endoscope reprocessing would become insufficient. NOTE If you collect the disinfectant solution from the drain port, the reduction of the solution inside the disinfectant solution tank may make it impossible to start reprocessing. 70 OER-Elite OPERATION MANUAL 3.7 Checking the MRC level and entering the check result Checking the MRC level Press the foot pedal to open the lid. Uncap the disinfectant solution nozzle of the reprocessing basin by turning the disinfectant solution nozzle cap in the direction shown right. Disinfectant solution nozzle cap Ch.3 Figure 3.45 Insert the test strip all the way into the disinfectant solution nozzle and check the MRC as described in the test strip instruction manual. If the concentration is lower than the effective level, replace the disinfectant solution by following the instructions in Section 8.2, “Replacing the disinfectant solution”. Figure 3.46 NOTE • Under high temperature and extreme temperature fluctuations, test strip may result in fail. In such cases, Olympus recommends performing mix LCG and check the MRC level again. • Depending on conditions of internal valve, there is a possibility that no disinfectant solution exist in the disinfectant solution nozzle. In the following cases, perform the mix LCG, then check the MRC level again. No reaction is observed on the chemical indicator after checking the MRC level. Reaction is observed only from the edge parts of the chemical indicator after checking the MRC level. If the disinfectant solution in the disinfectant solution nozzle is found insufficient for checking the MRC level on a regular basis, contact Olympus. OER-Elite OPERATION MANUAL 71 3.7 Checking the MRC level and entering the check result Attach the disinfectant solution nozzle cap to the original position on the disinfectant solution nozzle. Make sure that the pin returns to the original position, and the projection of the disinfectant solution nozzle cap is aligned to the projection of the disinfectant solution nozzle. Ch.3 Pin projection Figure 3.47 NOTE Be sure to return the disinfectant solution nozzle cap to the original position. Otherwise, the disinfectant solution inside the nozzle may be diluted in the next process and next MRC check will be failed even if the concentration of LCG in the tank is above its MRC. In this case, perform mix LCG, then check MRC again. Entering the check result Display the Reprocessing Standby screen and Press the “MRC Check” button. Figure 3.48 72 OER-Elite OPERATION MANUAL 3.7 Checking the MRC level and entering the check result NOTE If the touch screen displays a screen as shown in following figure, perform the LCG Mixing. If not completed Mix LCG, cannot see the MRC check result. For detailed on “Mix LCG”, refer to Section 7.4, “Mix LCG”. Ch.3 Figure 3.49 Select the button that corresponds with the result of the MRC check. The button turns white. Select the result of the MRC check using the test strip. Figure 3.50 OER-Elite OPERATION MANUAL 73 3.7 Checking the MRC level and entering the check result NOTE • Input the user ID by following the instructions in Section 3.6, “Entering ID” (If applicable). Hold the user ID card in parallel with the ID reader section of the reprocessor or press the “Edit” button for software keyboard input. Ch.3 Figure 3.51 • The user ID input can be omitted according to the user ID input setting. For details, refer to Section 4.5, “User ID Setting”. Press the “Save” button. Figure 3.52 NOTE If the “Save” button is pressed after “Fail” has been selected, the processes that use the disinfectant solution cannot be started. 74 OER-Elite OPERATION MANUAL 4.1 Setting menu Chapter 4 4.1 Settings Setting menu To change the settings of the reprocessor, press “Settings” on the Menu Screen. This menu is composed of three pages. To go between the pages, press the next page button or the previous page button. Ch.4 OER-Elite OPERATION MANUAL 75 4.1 Setting menu Ch.4 No. Button Description Setting item button Press to display the buttons for starting various Functions. Press the button for the desired function. Page 1 This setting sets the timing of auto leak test when it is included in the reprocessing process. oRefer to Section 4.2, “Auto leak test setting”. Auto Leak Test Setting MRC Check Setting When this setting is activated and the MRC check result is not input before start of the following process, the reprocessor inhibits the start of the following process and message screen is displayed. oRefer to Section 4.3, “MRC check setting”. Manual Cleaning and Leak Test Setting When this setting is activated, the confirmation results of a manual cleaning and the leak test before manual cleaning can be selected after the scope ID input. oRefer to Section 4.4, “Manual cleaning and leak test setting”. Patient ID Security Setting When the setting is activated, patient data will not be exported or printed from the OER-Elite. Even this setting is activated, data except the patient data can be exported to the portable memory or printed. oRefer to Section 4.8, “Patient ID security setting”. User ID Setting When this setting is activated, the user ID can be input in each process. oRefer to Section 4.5, “User ID Setting”. Physician ID Setting When this setting is activated, the physician ID of the endoscope performing the examination can be input before starting reprocessing process and leaking scope decontamination and recorded in the reprocessing record. oRefer to Section 4.6, “Physician ID setting”. Patient ID Setting When this setting is activated, the ID of the patient receiving the endoscopic examination can be input and recorded in the reprocessing records. oRefer to Section 4.7, “Patient ID setting”. Procedure ID Setting When this setting is activated, the procedure ID can be entered before starting “Reprocessing”. oRefer to Section 4.9, “Procedure ID setting”. Menu button Press to go to the Menu. Next page button Press to go to the next page. When there is no further page to go forward to, the button turns gray and becomes unavailable. 76 OER-Elite OPERATION MANUAL 4.1 Setting menu No. Button Page 2 Ch.4 Description Detergent Replacement Indicator When this setting is activated, the reprocessor counts the day count (number of days the detergent is effective after replacement) after each replacement of detergent and displays the detergent replacement indicator when the day counts reach to the set value. After reaching to the set value, a pop-up message screen opens prior to the start of reprocessing and inhibit starting the process. oRefer to Section 4.10, “Detergent replacement indicator”. Detergent Lot # & Shelf-Life Management This setting sets the shelf life and lot number that are input when replacing the detergent. oRefer to Section 4.11, “Detergent lot number and shelf-life management”. LCG Replacement Indicator This setting sets the display of the disinfectant solution replacement indicator. oRefer to Section 4.12, “LCG replacement indicator”. LCG Lot # & Shelf-Life Management This setting sets the shelf life and lot number that are input when replacing the disinfectant solution. oRefer to Section 4.13, “LCG lot number and shelf-life management”. Filter Replacement Indicator This setting sets the display of the Filter Replacement Indicator. oRefer to Section 4.14, “Filter replacement indicator”. Filter Lot # Management This setting sets the lot number that is input when replacing the filters. oRefer to Section 4.15, “Filter lot number management”. Auxiliary Water Tube Cleaning Setting This setting sets the reprocessing of the auxiliary water tube together with endoscopes. oRefer to Section 4.16, “Auxiliary water tube cleaning setting”. Print Option This setting sets the auto printing of the result of reprocessing, auto leak test, manual leak test or leaking scope decontamination. To activate this setting, an optional MAJ-2144 printer set is necessary. oRefer to Section 4.17, “Print option”. Menu button Press to go to the Menu. LCG Info. button Press to open the LCG Info. display. oRefer to Section 3.5, “LCG Info. screen”. Previous page button Press to return to the previous. When there is no further page to turn back to, the button turns gray and becomes unavailable. Next page button Press to go to the next page. When there is no further page to go forward to, the button turns gray and becomes unavailable. OER-Elite OPERATION MANUAL 77 4.1 Setting menu Ch.4 No. Button Page 3 Description Start Screen This setting sets the display that appears after the startup display at power ON. oRefer to Section 4.18, “Start screen”. Connection Guide This setting sets the automatic display of the Connection Guide screen after the Scope ID reading in the reprocessing program. oRefer to Section 4.19, “Connection guide”. Volume and Brightness This setting sets the volume of buzzer sound, etc., the brightness of the touch screen and the panel press tone. oRefer to Section 4.20, “Volume and brightness”. Date and Time This setting sets the date display format and the clock of the reprocessor. oRefer to Section 4.21, “Date and time”. Temperature Scale This setting sets the scale used in the disinfectant solution temperature display. oRefer to Section 4.22, “Temperature scale”. Network This setting sets the information required for connecting the reprocessor to a Network. oRefer to Section 4.23, “Network setting”. Network Security This setting sets the security of the Network-related Settings. oRefer to Section 4.24, “Network security”. Menu button Press to go to the Menu. LCG Info. button Press to open the LCG Info. display. oRefer to Section 3.5, “LCG Info. screen”. Previous page button Press to return to the previous. When there is no further page to turn back to, the button turns gray and becomes unavailable. 78 OER-Elite OPERATION MANUAL 4.2 Auto leak test setting 4.2 Auto leak test setting This setting is to set the timing of the auto leak test when this function is included in the reprocessing process. For the auto leak test in the reprocessing process, refer to “ Auto leak test” on page 221. CAUTION Always perform leak test in a sink before manual cleaning. If the endoscope has a water leaking point, water may penetrate the scope during manual cleaning, in which case the scope may break down. Ch.4 Select the “Auto Leak Test Setting” on the settings menu. OER-Elite OPERATION MANUAL 79 4.2 Auto leak test setting Select setting from options. Ch.4 No. Item/Button Setting options ALT setting Description Beginning of the process Auto leak test is performed at the starting of “Reprocessing”. The reprocessing process time is extended by about 2 minutes. If “Beginning of the process” is selected and hot water is used for manual cleaning, the ALT result may be “Leaked” even though the endoscope has no leakage. The leak test result may become “Leaked” depending on the temperature of the endoscope. To perform auto leak test with the ultrasonic endoscope, wait for more than 30 minutes. To perform it with the other type of endoscope, wait for more than 15 minutes. End of the process (default) Auto leak test is performed at the end of “Reprocessing”. The reprocessing process time is extended by about 2 – 7 minutes. When “End of the process” was chosen and there is a leak with an endoscope, water may enter the endoscope from the leakage point. Cancel – Returns to the Setting menu without saving the selected setting. Save – Returns to the Setting menu after saving the selected setting. NOTE The selected settings are displayed with white buttons. 80 Press the “Save” button to save the selected setting. OER-Elite OPERATION MANUAL 4.3 MRC check setting 4.3 MRC check setting When this setting is activated and the MRC check result is not input before start of the following process, the reprocessor inhibits the start of the following process and message screen is displayed. Reprocessing Leaking Scope Decontamination Water Line Disinfection Self-disinfection & Water sampling Detergent Line Disinfection Ch.4 Alcohol Line Disinfection NOTE This setting is provided to prevent forgetting of the input of the MRC check result. The MRC check result can be input even when this setting is disabled. Select “MRC Check Setting” on the settings menu. Select setting from options. No. Item/Button Setting options MRC Check Setting OFF Description The reprocessing process starts even if the disinfectant solution concentration check result is not input. ON (default) If the disinfectant solution concentration check result is not input before start of the process, the reprocessor inhibits start of the process and notifies that the check result is not input. Cancel – Returns to the Setting menu without saving the selected setting. Save – Returns to the Setting menu after saving the selected setting. OER-Elite OPERATION MANUAL 81 4.4 Manual cleaning and leak test setting NOTE The selected settings are displayed with white buttons. 4.4 Press the “Save” button to save the selected setting. Manual cleaning and leak test setting When this setting is activated, users can confirm if a manual cleaning and leak test have been performed based on the scope ID. When the setting is On, those inputs are necessary. The manual cleaning and leak test confirmations are linked to the scope ID's reprocessing records or leaking scope decontamination records. Ch.4 Select “Manual Cleaning and leak test Setting” on the settings menu. Select setting from options. No. Item/Button Setting options Description Manual Cleaning and leak test Setting OFF Disables the data entry for result of manual cleaning and leak test. ON (default) Before starting “Reprocessing” and “Leaking Scope Decontamination” are entered for each endoscope's result about manual cleaning and leak test. Cancel – Returns to the Setting menu without saving the selected setting. Save – Returns to the Setting menu after saving the selected setting. NOTE The selected settings are displayed with white buttons. 82 OER-Elite OPERATION MANUAL 4.5 User ID Setting 4.5 Press the “Save” button to save the selected setting. User ID Setting When this setting is activated, the user ID can be inputted in each process and the process cannot be started without inputting User ID. Select “User ID setting” on the Settings menu. Select the function to change the user ID setting. Ch.4 No. Button Description Reprocessing Goes to the user ID Setting for “Reprocessing”. oRefer to “ User ID setting (reprocessing)” on page 84. Functions & Replacement of Consumable Items Goes to the user ID Setting for “Functions” and “Replacement of Consumable Items”. oRefer to “ User ID setting (functions and replacement)” on page 86. Heat LCG Timer Goes to the user ID Setting for “Heat LCG Timer”. oRefer to “ User ID setting (Heat LCG Timer)” on page 87. Menu Returns to the Menu screen. LCG Info. Open the disinfectant information screen. Cancel Returns to the Setting menu. OER-Elite OPERATION MANUAL 83 4.5 User ID Setting User ID setting (reprocessing) When this setting is activated, User ID can be entered before and/or after starting reprocessing process and recorded in the reprocessing record. Select the setting for user ID entry before beginning of reprocessing process. Ch.4 No. Setting Options Description OFF Disables the user ID entry before starting reprocessing process. (A) ON One User ID can be input for two endoscopes before starting reprocessing process. (B) ON (default) User ID can be input for each endoscope before starting reprocessing process. Cancel Returns to the previous screen. Next Goes to the next setting. NOTE • The selected settings are displayed with white buttons. • Only one User ID can be input at the end of reprocessing process. • If the setting is activated, User ID input before beginning reprocessing process cannot be skipped. 84 Press the “Next” button. OER-Elite OPERATION MANUAL 4.5 User ID Setting Select the setting for User ID entry at the end of reprocessing process. No. Setting Options Ch.4 Description OFF Disable the user ID entry at the end of reprocessing process. ON (default) User ID can be input at the end of reprocessing process. The lid is locked until user ID entry is completed. Back Returns to the previous screen. Save Returns to two previous menu after saving the selected setting. NOTE • The selected settings are displayed with white buttons. • If the setting is activated, user ID input at the end of reprocessing process cannot be skipped. Press the “Save” button to save the selected settings. OER-Elite OPERATION MANUAL 85 4.5 User ID Setting User ID setting (functions and replacement) When this setting is activated, user ID can be entered before starting each process of “Functions” and “Replacement of Consumable Items” and recorded in the reprocessing record. Select setting from options. Ch.4 No. Item/Button Setting options Description User ID Setting OFF (Functions & Replacement of ON (default) Consumable Items) User ID can be input before starting each process of “Functions” and “Replacement of Consumable Items”. Cancel – Returns to the Setting menu without saving the selected setting. Save – Returns to the Setting menu after saving the selected setting. Disable the user ID entry for “Functions” and “Replacement of Consumable Items”. NOTE The selected settings are displayed with white buttons. 86 Press the “Save” button to save the selected setting. OER-Elite OPERATION MANUAL 4.5 User ID Setting User ID setting (Heat LCG Timer) When this setting is activated, user ID can be entered before starting “Heat LCG Timer” and recorded in the reprocessing record. Select setting from options. Ch.4 No. Item/Button Setting options Description User ID Setting (Heat LCG Timer) OFF Disable the user ID entry for “Heat LCG Timer”. ON (default) Before starting “Heat LCG Timer” are entered the user ID. Cancel – Returns to the Setting menu without saving the selected setting. Save – Returns to the Setting menu after saving the selected setting. NOTE The selected settings are displayed with white buttons. Press the “Save” button to save the selected setting. OER-Elite OPERATION MANUAL 87 4.6 Physician ID setting 4.6 Physician ID setting When this setting is activated, the physician ID of the endoscopist can be input before starting reprocessing process and leaking scope decontamination and recorded in the reprocessing record. Select “Physician ID Setting” on the settings menu. Select setting from options. Ch.4 No. Item/Button Setting options Physician ID Setting Description OFF Disable the physician ID entry for “Reprocessing” and “Leaking Scope Decontamination”. ON (default) User can enter the physician ID before starting “Reprocessing” and “Leaking Scope Decontamination”. Cancel – Returns to the Setting menu without saving the selected setting. Save – Returns to the Setting menu after saving the selected setting. NOTE The selected settings are displayed with white buttons. 88 Press the “Save” button to save the selected setting. OER-Elite OPERATION MANUAL 4.7 Patient ID setting 4.7 Patient ID setting When this setting is activated, the ID of the patient receiving the endoscopic examination can be input and recorded in the reprocessing records and recorded in the reprocessing record. Select “Patient ID Setting” on the settings menu. Select setting from options. Ch.4 No. Item/Button Setting options Patient ID Setting Description OFF Disable the patient ID entry for “Reprocessing” and “Leaking Scope Decontamination”. ON (default) User can enter the patient ID before starting “Reprocessing” and “Leaking Scope Decontamination”. Cancel – Returns to the Setting menu without saving the selected setting. Save – Returns to the Setting menu after saving the selected setting. NOTE The selected settings are displayed with white buttons. Press the “Save” button to save the selected setting. OER-Elite OPERATION MANUAL 89 4.8 Patient ID security setting 4.8 Patient ID security setting When the setting is activated, patient data will not be exported or printed from the OER-Elite. Even this setting is activated, all data, with exception of patient data can be exported to the portable memory or printed and recorded in the reprocessing record. Select “Patient ID Security Setting” on the settings menu. Select setting from options. Ch.4 No. Item/Button Patient ID Security Setting Setting options Description OFF (default) The patient ID is printed on the printer and output to a portable memory. ON The printout of the patient ID and its output to a portable memory are inhibited. Cancel – Returns to the Setting menu without saving the selected setting. Save – Returns to the Setting menu after saving the selected setting. NOTE The selected settings are displayed with white buttons. 90 Press the “Save” button to save the selected setting. OER-Elite OPERATION MANUAL 4.9 Procedure ID setting 4.9 Procedure ID setting When this setting is activated, the procedure ID can be entered before starting reprocessing process and recorded in the reprocessing record. Select “Procedure ID” on the Settings menu. Select setting from options. Ch.4 No. Item/Button Setting options Procedure ID Settings Description OFF Disable the procedure ID entry for “Reprocessing” and “Leaking scope decontamination”. ON (default) User can enter the procedure ID before starting “Reprocessing” and “Leaking scope decontamination”. Cancel – Returns to the Setting menu without saving the edited information. Save – Returns to the Setting menu after saving the edited information. NOTE The selected settings are displayed with white buttons. Press the “Save” button to save the selected settings. OER-Elite OPERATION MANUAL 91 4.10 Detergent replacement indicator 4.10 Detergent replacement indicator When this setting is activated, the reprocessor counts the day count (number of days the detergent is effective after replacement) after each replacement of detergent and displays the detergent replacement indicator when the day counts reach to the set value. After reaching to the set value, a pop-up message screen opens prior to the start of reprocessing. NOTE • For details of the indicator, refer to Section 3.2, “Alarm indicator”. • When replace the consumable item after changing date and time, the Detergent replacement indicator might not be displayed incorrectly. Ch.4 Select “Detergent Replacement Indicator” on the settings menu. Select setting from options of the Detergent replacement indicator. To change the setting value, press “Edit” button. No. Item/Button Setting options Description Detergent replacement indicator OFF Disables the detergent replacement indicator. ON (default) The reprocessor counts the day count (number of days the detergent is effective after replacement) after each replacement of detergent. And the detergent replacement indicator is displayed when the day count is reached to the set value. Edit – Goes to the screen for editing set value of day count. Cancel – Returns to the Setting menu without saving the edited information. Save – Returns to the Setting menu after saving the edited information. NOTE The selected settings are displayed with white buttons. 92 OER-Elite OPERATION MANUAL 4.10 Detergent replacement indicator If “Edit” button is pressed in the previous screen, following screen is displayed. Edit the number of days, and press “OK” button. Ch.4 No. Item/Button Setting options Description Days 1 – 30 [days] (default: 30) Sets the set value of days for the detergent replacement indicator. Pressing the “+” button increments the setting and pressing the “–” button decrements it. Cancel – Returns to the previous screen without saving the edited information. OK – Returns to the previous menu after saving the edited information. Press the “Save” button to return to the Setting menu after saving the edited information. Figure 4.1 NOTE For details of the indicator, refer to Section 3.2, “Alarm indicator”. OER-Elite OPERATION MANUAL 93 4.11 Detergent lot number and shelf-life management 4.11 Detergent lot number and shelf-life management When this setting is activated, the detergent lot number and shelf life can be input during a detergent replacement. For details on replacement of each information, both information is referred to Section 8.2, “Replacing the disinfectant solution” and Section 8.3, “Replacing the detergent tank”. The reprocessor displays the detergent replacement indicator when the shelf life is reached. After reaching the shelf life, a pop-up message screen opens prior to the start of reprocessing and inhibits starting the process. The lot number and shelf life are linked with the detergent replacement record. Ch.4 Select “Detergent Lot #& shelf life management” on the Setting menu. Select each setting from options. No. Item/Button Lot # Management (Detergent) OFF (default) Disables the lot number entry for detergent. ON User can enter lot number of detergent. Shelf-life Management (Detergent) OFF (default) Disables the shelf-life entry for detergent. ON User can enter shelf-life of detergent. Cancel – Returns to the Setting menu without saving the selected settings. Save – Returns to the Setting menu after saving the selected settings. Setting options Description NOTE The selected settings are displayed with white buttons. 94 Press the “Save” button to return to the Setting menu after saving the selected settings. OER-Elite OPERATION MANUAL 4.12 LCG replacement indicator 4.12 LCG replacement indicator When this setting is activated, the reprocessor counts a LCG day count (number of days the disinfectant solution is effective after replacement) and a LCG usage count (number of cycles the disinfectant solution is effective after replacement) after Loading LCG process. In addition, the reprocessor displays the disinfectant replacement indicator when the day counts or the usage counts reach each set value. You can set the number of days and the maximum number of disinfection cycles prior to replacement of the disinfectant solution. The reprocessor indicates the replacement timing when the set value for the elapsed days or operations is reached as a reference or reminder for disinfectant solution replacement. Note that this reprocessor does not determine the degradation of the disinfectant concentration. It is recommended to update the set value according to changes in the operating environment, etc. WARNING Be sure to check a concentration of the disinfectant solution by using a separately available test strips. The LCG replacement indicator does not determine the effectiveness of the disinfectant solution. The expiration of the disinfectant solution varies depending on many factors including the time after activation, the temperature of the environment where the reprocessor is installed, and the number and types of endoscopes that have been reprocessed. The LCG replacement indicator does not take these and other factors into consideration. NOTE • For details of indicator, refer to Section 3.2, “Alarm indicator”. • When replace the consumable item after changing date and time, the disinfectant solution replacement indicator might not be displayed incorrectly. OER-Elite OPERATION MANUAL 95 Ch.4 4.12 LCG replacement indicator Select “LCG Replacement Indicator” on the Setting menu. Select setting from options. To change the setting value, press “Edit” button. Ch.4 No. Item/Button Setting options Description LCG Replacement Indicator OFF Disables the LCG replacement indicator. ON (default) The LCG replacement indicator is displayed when a day count or usage count is reached to the set value. Edit – Edit the setting value. Cancel – Returns to the Setting menu without saving the edited information. Save – Returns to the Setting menu after saving the edited information. NOTE The selected settings are displayed with white buttons. 96 OER-Elite OPERATION MANUAL 4.12 LCG replacement indicator If “Edit” button is pressed in the previous screen, following screen is displayed. Edit the number of days and cycles, and press “OK” button. No. Item/Button Ch.4 Setting options Description Days 1 – 5 [days] (default: 3) Sets the set value of days for the LCG replacement indicator. Pressing the “+” button increments the setting and pressing the “–” button decrements it. Cycles 1 – 35 [usages] (default: 15) Sets the set value of cycles for the LCG replacement indicator. Pressing the “+” button increments the setting and pressing the “–” button decrements it. Cancel – Returns to the Setting menu without saving the edited information. OK – Returns to the Setting menu after saving the edited information. Press the “Save” button to return to the Setting menu after saving the edited information. Figure 4.2 NOTE For details of the indicator, refer to Section 3.2, “Alarm indicator”. OER-Elite OPERATION MANUAL 97 4.13 LCG lot number and shelf-life management 4.13 LCG lot number and shelf-life management When this setting is activated, the disinfectant solution lot number and shelf life can be input during Loading LCG process. If the shelf life is reached, both the message and disinfectant replacement indicator are displayed on the screen and the reprocessor inhibits starting the process automatically. For details how to do setting the Lot number and shelf-life, refer to Section 8.2, “Replacing the disinfectant solution”. Select “LCG Lot # & Shelf-Life Management” on the Setting menu. Select each setting from options. Ch.4 No. Item/Button Lot # Management (Disinfectant) OFF (default) Disables the lot number entry for disinfectant solution. ON Enables the lot number is entered for disinfectant solution. Shelf-life Management (Disinfectant) OFF (default) Disables the shelf-life entry for disinfectant solution. ON User can enter shelf-life of disinfectant solution. Cancel – Returns to the Setting menu without saving the selected settings. Save – Returns to the Setting menu after saving the selected settings. Setting options Description NOTE The selected settings are displayed with white buttons. 98 Press the “Save” button to return to the Setting menu after saving the selected settings. OER-Elite OPERATION MANUAL 4.14 Filter replacement indicator 4.14 Filter replacement indicator When this setting is activated, the reprocessor displays the filter replacement indicator when day counts of each filter reach the set value. After reaching the set value, a pop-up message screen opens soon after powering ON the reprocessor. When this setting is activated, the reprocessor counts the day count (number of days of the each filter is effective after replacement) after each replacement of filters. If the day counts reach the set value, both the message and the filter replacement indicator are displayed on the touch screen. NOTE • For details of indicator, refer to Section 3.2, “Alarm indicator”. Ch.4 • When replace the consumable item after changing date and time, the filter replacement indicator might not be displayed incorrectly. Select “Filter Replacement Indicator” on the Setting menu. Select each setting from options. To change the setting value, press “Edit” button. OER-Elite OPERATION MANUAL 99 4.14 Filter replacement indicator Ch.4 No. Item/Button Setting options Description Water filter replacement indicator OFF Disables the filter replacement indicator of water filter. ON (default) The water filter replacement indicator is displayed when the day count is reached the set value. Edit – To change the day count of water filter, press the “Edit” button to open the Water Filter Indicator screen. oRefer to “ Editing the set value for water filter” on page 101. Air filter replacement indicator OFF Disables the filter replacement indicator of air filter. ON (default) The air filter replacement indicator is displayed when the set day count is reached. Edit – To change the day count of the air filter, press the “Edit” button to open the Air Filter Indicator screen. oRefer to “ Editing the setting value for air filter” on page 102. Gas filter replacement indicator OFF Disables the filter replacement indicator of gas filter. ON (default) The gas filter replacement indicator is displayed when the set day count is reached. Edit – To change the day count of the gas filters on lid and tank, press the “Edit” button to open the Gas Filter Indicator screen. oRefer to “ Editing the set value for gas filter” on page 102. Cancel – Returns to the Setting menu without saving the edited information. Save – Returns to the Setting menu after saving the edited information. NOTE The selected settings are displayed with white buttons. 100 Press the “Save” button to save the edited information. OER-Elite OPERATION MANUAL 4.14 Filter replacement indicator Editing the set value for water filter Ch.4 No. Item/Button Setting options Pre-filtering Description With the pre-filter When the pre-filter is used, select this option to expand the setting range of day count up 180 days. Without the pre-filter (default) When the pre-filter is not used, select this option to restrict the setting range of day count 30 days. Days 1 – 180 [days] or 1 – 30 [days] (default: 30) Sets the set value of days for the filter replacement indicator of water filter. Pressing the “+” button increments the setting and pressing the “–” button decrements it. The setting range varies depending on the usage of pre-filter. Cancel – Returns to the previous screen without saving the edited information. OK – Returns to the previous screen after saving the edited information. NOTE The selected settings are displayed with white buttons. OER-Elite OPERATION MANUAL 101 4.14 Filter replacement indicator Editing the setting value for air filter Ch.4 No. Item/Button Setting options Description Days 1 – 30 [days] (default: 30) Sets the set value of days for the filter replacement indicator of air filter. Pressing the “+” button increments the setting and pressing the “–” button decrements it. Cancel – Returns to the previous screen without saving the edited information. Save – Returns to the previous screen after saving the edited information. Editing the set value for gas filter No. Item/Button Setting options Description Days 1 – 30 [days] (default: 30) Sets the set value of days for the filter replacement indicator of gas filter. Pressing the “+” button increments the setting and pressing the “–” button decrements it. Cancel – Returns to the Setting menu without saving the edited information. Save – Returns to the Setting menu after saving the edited information. 102 OER-Elite OPERATION MANUAL 4.15 Filter lot number management 4.15 Filter lot number management When this setting is activated, filter lot number can be input during replacement of a water, air, or gas filter. For details on replacement of each filters, water filter is referred to Section 8.4, “Replacing the water filter (MAJ-824 or MAJ-2318)”, air filter is referred to Section 8.5, “Replacing the air filter (MAJ-823)”, and gas filter is referred to Section 8.6, “Replacing the gas filter (MAJ-822)”. Select “Filter Lot # Management” on the Setting menu. Press “ON” or “OFF” button for each setting. Ch.4 No. Item/Button Setting options Water Filter Air Filter Gas Filter (Lid) Gas Filter (Tank) Description OFF (default) Disables the lot number entry for water filter. ON Enables the lot number is entered for water filter. OFF (default) Disables the lot number entry for air filter. ON User can enter the lot number of air filter. OFF (default) Disables the lot number entry for gas filter on the lid. ON User can enter the lot number of gas filter on the lid. OFF (default) Disables the lot number entry for gas filter on the tank. ON User can enter the lot number of gas filter on the tank. Cancel – Returns to the Setting menu without saving the edited information. Save – Returns to the Setting menu after saving the edited information. NOTE The selected settings are displayed with white buttons. Press the “Save” button to save the selected settings. OER-Elite OPERATION MANUAL 103 4.16 Auxiliary water tube cleaning setting 4.16 Auxiliary water tube cleaning setting When this setting is activated, an auxiliary water tube (MAJ-855) can be reprocessed simultaneously with an endoscope with water jet function by using dedicated connecting tube MAJ-2138. In this case, two endoscopes with two auxiliary water tubes can be reprocessed in one reprocessing process. To obtain optional connecting tube MAJ-2138, contact Olympus. WARNING If the setting is activated, always use connecting tube MAJ-2138 for an endoscope with water jet function. Otherwise, channel connectivity monitoring may not be able to detect improper connection of the connecting tubes. Ch.4 NOTE • If the setting is activated, the Connection guide screen which appears after reading the scope ID displays MAJ-2138 as the connecting tube to be connected to the water jet function. • If the setting is activated, an endoscope with water jet function cannot be reprocessed without an auxiliary water tube (MAJ-855). • If this setting is disabled, either 2 endoscopes or 1 endoscope and 1 auxiliary water tube (MAJ-855) can be simultaneously reprocessed. • For details how to install endoscopes and auxiliary water tubes simultaneously, refer to Section 6.6, “Loading of endoscopes and accessories”. 104 Select “Auxiliary Water Tube Cleaning Setting” on the Setting menu. Select setting from options. Then press “OK” or “Save” button. OER-Elite OPERATION MANUAL 4.16 Auxiliary water tube cleaning setting Ch.4 No. Item/Button Setting options Description Auxiliary Water Tube Cleaning Setting OFF (default) Disables the auxiliary water tube cleaning setting. ON Auxiliary water tubes (MAJ-855 or MAJ-2021) can be reprocessed simultaneously with endoscopes with water jet function by using dedicated connecting tube MAJ-2138. Cancel – Returns to the Setting menu without saving the selected setting. Save/OK – When the “OFF” is selected, “Save” button is displayed here. Press this button to return to the setting menu after saving the selected setting. When the “ON” is selected, “OK” button is displayed here. Press this button to go to the confirmation screen about activating this setting. NOTE The selected settings are displayed with white buttons. When “ON” was selected in the setting, this confirmation screen is displayed. Read the description and press the “Save” button to save the setting. Figure 4.3 OER-Elite OPERATION MANUAL 105 4.17 Print option 4.17 Print option This step is to make the settings for the auto printing function and the print format for auto printing function. NOTE To print a record, an optional MAJ-2144 printer set is necessary. Ch.4 Select “Print Option” on the Setting menu. Select the item that you want to change the print option settings. No. Item/Button Description Print Format Goes to the “Print Format Setting”. oRefer to “ Print format setting” on page 107. Auto Print Goes to the “Auto Print”. oRefer to “ Auto Print Setting” on page 108. Menu Returns to the Menu. LCG Info Press to open the LCG Info display. oRefer to Section 3.5. “LCG Info. Screen” Cancel Returns to the Setting menu. 106 OER-Elite OPERATION MANUAL 4.17 Print option Print format setting Select “Print Format” on the Print option menu. Select setting from options. Ch.4 No. Item/Button Print Format Setting Setting options Description (A) Separate (default) The results of two endoscopes in a process are printed out one after the other. (B) Combine The results of two endoscopes in a process are combined in one result and printed out. Cancel – Returns to the previous screen without saving the selected setting. Save – Returns to the previous screen after saving the selected setting. NOTE • For details of the print format, refer to Section 6.10, “Printing of the reprocessing records”. • The selected settings are displayed with white buttons. Press the “Save” button to save the selected setting. OER-Elite OPERATION MANUAL 107 4.17 Print option Auto Print Setting If this setting is activated, Reprocessing result and Leak Testing result will print automatically after the process is complete. NOTE • To print a record, an optional MAJ-2144 printer set is necessary. • If the printer is not connected to the reprocessor although “Auto Print” is selected, [E094] error occurs at the completion of reprocessing process, leak test, and leaking scope decontamination. Ch.4 Select “Auto Print” on the Print option menu. Select setting from options. No. Item/Button Setting options Auto Print Setting Description OFF (default) Disable the auto printing for “Reprocessing”. ON Enable the auto printing for “Reprocessing”. Cancel – Returns to the previous screen without saving the selected setting. Save – Returns to the previous screen after saving the selected setting. NOTE The selected settings are displayed with white buttons. 108 Press the “Save” button to save the selected setting. OER-Elite OPERATION MANUAL 4.18 Start screen 4.18 Start screen The start screen, which is displayed after turning on the reprocessor, can be chosen from Reprocess standby screen or Menu screen. Select “Start Screen” on the Setting menu. Select setting from options. Ch.4 No. Item/Button Setting options Start Screen setting Reprocessing standby Description The menu screen does not appear automatically the reprocessing standby screen. Menu (default) The menu screen appears as the start screen. Cancel – Returns to the Setting menu without saving the selected setting. Save – Returns to the Setting menu after saving the selected setting. NOTE The selected settings are displayed with white buttons. Press the “Save” button to save the selected setting. OER-Elite OPERATION MANUAL 109 4.19 Connection guide 4.19 Connection guide When this setting is activated, the connection guide screen is displayed after inputting scope ID with RFID. For details, refer to “ Connection guide of first endoscope” on page 179, or “ Connection guide of second endoscope” on page 206. Select “Connection Guide” on the Setting menu. Select setting from options. Ch.4 No. Item/Button Setting options Connection Guide Description OFF Disable the Connection Guide screen. ON (default) The Connection Guide screen appears automatically when scope ID is entered. Cancel – Returns to the Setting menu without saving the selected setting. Save – Returns to the Setting menu after saving the selected setting. NOTE The selected settings are displayed with white buttons. 110 Press the “Save” button to save the selected setting. OER-Elite OPERATION MANUAL 4.20 Volume and brightness 4.20 Volume and brightness The buzzer volumes and touch screen brightness can be adjusted. Also, when the panel click sound setting is activated, a click sound can be generated when a button on the touch screen is pressed. Select “Volume and Brightness” on the Setting menu. Edit the settings. Ch.4 No. Item/Button Setting options Description Volume 5 steps (default: 3) Sets the volume of the buzzer in 5 steps. Pressing the “+” button increments the setting and pressing the “–” button decrements it. Brightness 5 steps (default: 3) Sets the brightness of the touch screen in 5 steps. Pressing the “+” button increases the brightness and pressing the “–” button decreases it. Click Sound ON (default) The click sound is generated when a button on the touch screen is pressed. OFF The click sound is not generated even when a button on the touch screen is pressed. Cancel – Returns to the Setting menu without saving the edited information. Save – Returns to the Setting menu after saving the edited information. Press the “Save” button to save the edited information. OER-Elite OPERATION MANUAL 111 4.21 Date and time 4.21 Date and time This setting can not only select date format and time format (either 12 or 24 hour clock), but also adjust date and time. NOTE When replace the consumable item after changing date and time, the alarm indicator might not be displayed incorrectly. Ch.4 Select “Date and Time” on the Setting menu. Select date format and time format. No. Item/Button Setting options Date Format Year/Month/Day Description Sets the format of the date display on the touch screen. Month/Day/Year (default) Day/Month/Year Time Format 12-hour clock (default) The hour is displayed in the 12-hour system, with “AM” for before noon or “PM” for the afternoon. 24-hour clock The hour is displayed in the 24-hour system. Cancel – Returns to the Setting menu without saving the edited information. Next – Goes to the next setting. NOTE The selected settings are displayed with white buttons. 112 OER-Elite OPERATION MANUAL 4.21 Date and time Press the “Next” button. Check and correct the date, and then press the “Next” button. Ch.4 No. Item/Button Setting options Description Month 1 – 12 Edit the figure of the current month. Pressing the “+” button increments the setting and pressing the “–” button decrements it. Day 1 – 31 Edit the figure of the current day. Pressing the “+” button increments the setting and pressing the “–” button decrements it. Year 2012 – 2087 Edit the figure of the current year. Pressing the “+” button increments the setting and pressing the “–” button decrements it. Cancel – Returns to the Setting menu without saving the edited information. Back – Returns to the previous screen. Next – Goes to the next setting. NOTE The order of year, month, and day displayed on the screen depends on the date format setting. OER-Elite OPERATION MANUAL 113 4.21 Date and time Check and correct the time, and then press the “Next” button. Ch.4 No. Item/Button Setting options Description Hour 0 – 11 (12-hour clock) 0 – 23 (24-hour clock) Edit the figure of the current hour. Pressing the “+” button increments the setting and pressing the “–” button decrements it. Minute 0 – 59 Edit the figure of the current minute. Pressing the “+” button increments the setting and pressing the “–” button decrements it. Cancel – Returns to the Setting menu without saving the edited information. Back – Returns to the previous screen. Next – Goes to the confirmation screen. Confirm the edited information and press the “Save” button. No. Item/Button Setting options Description Cancel – Returns to the Setting menu without saving the edited information. Back – Returns to the previous screen. Save – Returns to the Setting menu after saving the edited information. 114 OER-Elite OPERATION MANUAL 4.22 Temperature scale 4.22 Temperature scale The temperature scale displayed on the touch screen can be selected in this setting. Select “Temperature Scale” from the Settings menu. Select setting from options. Ch.4 No. Item/Button Setting options Description Fahrenheit (default) The temperature is displayed in the Fahrenheit scale (unit: qF). Setting Celsius The temperature is displayed in the Celsius scale (unit: qC). Cancel – Returns to the Setting menu without saving the edited information. Save – Returns to the Setting menu after saving the edited information. NOTE The selected settings are displayed with white buttons. Press the “Save” button to save the selected setting. OER-Elite OPERATION MANUAL 115 4.23 Network setting 4.23 Network setting The communication parameters with external equipment can be set. On the Setting menu, select “Network”. If the “Network Security” setting is not activated, go to Step 3 below. For details of “Network Security”, refer to Section 4.24, “Network security”. If the “Network Security” setting is activated, the password authentication screen appears. Enter the password and press the “OK” button. If a wrong password is entered, the entire password is cleared. In this case, re-enter the correct password. Ch.4 No. Button Description Numeric buttons Press to enter the value. Delete Deletes one character. Cancel Returns to the Setting menu without saving the edited information. OK The input password will be checked. When the password is correct, the network setting screen appears. If the password is erroneous, the entire input password is cleared. NOTE If you forget the password, contact Olympus. 116 This setting consists of three pages. Switch the page using the next page button or the previous page button, and edit the settings in each page. OER-Elite OPERATION MANUAL 4.23 Network setting Page 1 Ch.4 No. Item/Button Setting options Communication Description OFF (default) The network communication function is disabled. ON The network communication function is enabled. Previous page button – This button is unavailable on this page. Next page button – Press to go to the next page. When there is no further page to go forward to, the button turns gray and becomes unavailable. Cancel – Returns to the Setting menu without saving the edited information. Save – Returns to the Setting menu after saving the edited information. NOTE Turning ON the “Communication” setting without connecting the OLYMPUS KE to the OER-Elite may lead to slower communications when connecting the OLYMPUS KE afterward. OER-Elite OPERATION MANUAL 117 4.23 Network setting Page 2 Ch.4 No. Item/Button Setting options Description IP address > OER-Elite Conforming to the IPV4 address setting. (default: 127.000.000.001) The IP address of the OER-Elite is displayed. Press the “Edit” button to open the screen for use in input. The following addresses are invalid: x.x.x.0 x.x.x.255 Net mask > OER-Elite Conforming to the IPV4 address setting. (default: 255.255.255.0) The subnet address of the OER-Elite is displayed. Press the “Edit” button to open the screen for use in input. Gateway > OER-Elite Conforming to the IPV4 address setting. (default: 127.000.000.001) The gateway of the OER-Elite is displayed. Press the “Edit” button to open the screen for use in input. Port No. > OER-Elite 0 – 65535 (default: 51900) The port No. of the OER-Elite is displayed. Press the “Edit” button to open the screen for use in input. Mac address > OER-Elite – The MAC address of the OER-Elite is displayed. The MAC address cannot be modified. Previous page button – Press to return to the previous page. When there is no further page to turn back to, the button turns gray and becomes unavailable. Next page button – Press to go to the next page. When there is no further page to go forward to, the button turns gray and becomes unavailable. Cancel – Returns to the Setting menu without saving the edited information. Save – Returns to the Setting menu after saving the edited information. 118 OER-Elite OPERATION MANUAL 4.23 Network setting Page 3 Ch.4 No. Item/Button Setting options Description Auto negotiation ON (default), OFF COMM Settings 100 Mbps full duplex (default), The communication method is displayed. 100 Mbps half duplex, Each press of the “Edit” button switches the 10 Mbps full duplex, communication method. 10 Mbps half duplex Timeout 1 – 255 seconds (default: 120 seconds) The time-out time is displayed. Press the “Edit” button to open the screen for use in input. Previous page button – Press to return to the previous page. When there is no further page to turn back to, the button turns gray and becomes unavailable. Next page button – This button is unavailable on this page Cancel – Returns to the Setting menu without saving the edited information. Save – Returns to the Setting menu after saving the edited information. The status of auto negotiation is displayed. Each press of the “Edit” button switches the setting values alternately. OFF: The auto negotiation is disabled. ON: The auto negotiation is enabled. Press the “Save” button to save the edited information. OER-Elite OPERATION MANUAL 119 4.23 Network setting Editing the setting of each item The settings of the following items can be edited: Reprocessor IP address Reprocessor net mask Reprocessor gateway Reprocessor port number Auto negotiation COMM Settings Timeout Ch.4 Press the “Edit” button for the IP address, etc. to open the screen for use in input. Enter the figures using the numeric buttons. No. Button Description Numeric buttons Press to enter the value. Moves the cursor to the right. Moves the cursor to the left. Cancel Returns to the previous screen by disabling the edited settings. OK Returns to the previous screen by enabling the edited settings. While the settings are not changed, the “OK” button turns gray. 120 Confirm the edited information and press the “OK” button to return to the previous screen. OER-Elite OPERATION MANUAL 4.24 Network security 4.24 Network security When this setting is activated, the network setting is protected with a password lock. The password can be changed by editing the network security password in this setting. When this setting is performed, the Network Settings are password-protected, and the screen of password authentication is displayed as Section 4.23, “Network setting”. Select “Network Security” on the Setting menu. Edit the settings. Ch.4 No. Item/Button Setting options Description Network Security Lock OFF (default) Password is unnecessary to open the network setting. ON Password is necessary to open the network setting. oRefer to Section 4.23, “Network setting”. “Edit” button (Network Security Lock) – If the network security lock is OFF, press to activate it and edit the new network security password. If the network security lock is ON, press to inactivate it. In this case, to input the network security password is necessary. “Edit” button (Network Security Password) – Press to change the password. If the network security lock is OFF, the button turns gray and becomes unavailable. Cancel – Returns to the Setting menu without saving the edited information Save – Returns to the Setting menu after saving the edited information. To change the “Network Security Lock”, refer to the following sections: “ Enabling the “Network Security Lock”” on page 122. “ Disabling the “Network Security Lock”” on page 123. To set a password, refer to “ Changing the password” on page 124. After completing the editing, press the “Save” button to save the edited information. OER-Elite OPERATION MANUAL 121 4.24 Network security Enabling the “Network Security Lock” Press the “Edit” button for the network security lock on the Network Security setting screen. Ch.4 Figure 4.4 Enter the new password up to 10 numbers and press the “OK” button. The password re-input screen appears. No. Button Description Numeric buttons Press to enter the value. Delete Deletes one character entered immediately before. Cancel Returns to the Setting menu without saving the edited information. OK Returns to the previous screen if the entered password is correct. All of the entered characters are cleared if the entered password is erroneous. 122 Enter the new password again and press the “OK” button. When the input password is correct, the password is changed and the screen returns to the Network Security setting screen. OER-Elite OPERATION MANUAL 4.24 Network security Disabling the “Network Security Lock” Press the “Edit” button for the network security lock on the Network Security setting screen. Ch.4 Figure 4.5 Enter the current password. When the entered password is correct, the password input screen closes and the security setting is disabled. No. Button Description Numeric buttons Press to enter the value. Delete Deletes one character entered immediately before. Cancel Returns to the previous screen by disabling the edited settings. OK Returns to the previous screen if the entered password is correct. All of the entered characters are cleared if the entered password is erroneous. OER-Elite OPERATION MANUAL 123 4.24 Network security Changing the password Press the “Edit” button for the network security password on the Network Security setting screen. Enter the current password. The password input screen appears when the entered password is correct. Ch.4 No. Button Description Numeric buttons Press to enter the value. Delete Deletes one character entered immediately before. Cancel Returns to the previous screen by disabling the edited settings. OK Returns to the previous screen if the entered password is correct. All of the entered characters are cleared if the entered password is erroneous. 124 OER-Elite OPERATION MANUAL 4.24 Network security On the password input screen, enter the new password and press the “OK” button. When the entered password is correct, the password re-input screen appears. Ch.4 No. Button Description Numeric buttons Press to enter the value. Delete Deletes one character entered immediately before. Cancel Returns to the previous screen by disabling the edited settings. OK Returns to the previous screen if the entered password is correct. All of the entered characters are cleared if the entered password is erroneous. On the password re-input screen, enter the new password again and press the “OK” button. When the input password is correct, the password is changed and the screen returns to the Network Security setting screen. OER-Elite OPERATION MANUAL 125 4.24 Network security Ch.4 126 OER-Elite OPERATION MANUAL 5.1 Inspection before use Chapter 5 5.1 Inspection and Preparation Before Use Inspection before use To ensure that this reprocessor operates safely and reliably, inspect and clean all parts before first use of the day. Also, check all consumables and replace or replenish as necessary. WARNING • When using the disinfectant solution and alcohol, Olympus recommends the use of gas filters and running this reprocessor in well-ventilated areas. Wear a face mask, gloves, and protective clothes to minimize aspiration and skin contact. Wear goggles for eye protection. Refer to the following association’s guidelines related to ventilation: SGNA (Society of Gastroenterology Nurses and Associates) ASGE (American Society of Gastroenterological Endoscopy) APIC (Association for Professionals of Infection Control and Epidemiology) AORN (Association of Preoperative Registered Nurses) ASTM (American Society for Testing and Materials) OSHA (Occupational Safety and Health Administration) ACGIH (American Conference of Governmental Industrial Hygienists) NIOSH (National Institute for Occupational Safety and Health) AIA (American Institute of Architects) If the person operating the reprocessor exhibits an allergic reaction or symptoms, no matter how slight, they should discontinue the task they are performing and vacate the room. • Be sure to perform all inspections and replenish consumables as described in this chapter. Otherwise, the reprocessor may not work properly. • If any irregularity is found during the inspections, do not use the reprocessor and contact Olympus. Using the reprocessor when an irregularity has been detected may impair operation of the reprocessor and could cause leakage, an electric shock, burns, and/or a fire and create an infection control risk. OER-Elite OPERATION MANUAL 127 Ch.5 5.2 Flow of inspection WARNING • During inspection, always wear appropriate personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged. 5.2 Flow of inspection On the first day you use the reprocessor, inspect it by following the procedure below. Ch.5 Check that the reprocessor can be turned ON. Section 5.3 on page 129 Check that no fluid leaks from the water supply line and inside the reprocessor. Section 5.4 on page 132 Check that the lid and its packing are free of irregularity. Check that the connectors of reprocessor are free of irregularity. Section 5.5 on page 133 Section 5.6 on page 134 Check that the connecting tubes and leak test air tube are free of irregularity. Section 5.7 on page 137 128 Check the remaining amount of detergent. Check the remaining amount of alcohol. Section 5.8 on page 138 Section 5.9 on page 139 OER-Elite OPERATION MANUAL
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