Olympus Medical Systems RU2020 Endoscope Reprocessor User Manual GT9883 0004 fm10
Olympus Medical Systems Corp. Endoscope Reprocessor GT9883 0004 fm10
Contents
Installation Manual 1
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| Document ID | 3575694 |
| Application ID | 5WVuu3vD2TKx6k5P50iqxA== |
| Document Description | Installation Manual 1 |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | Yes |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 129.1kB (1613793 bits) |
| Date Submitted | 2017-09-22 00:00:00 |
| Date Available | 2018-03-21 00:00:00 |
| Creation Date | 2017-09-14 09:08:41 |
| Producing Software | Acrobat Distiller 9.2.0 (Windows) |
| Document Lastmod | 2017-09-14 09:28:00 |
| Document Title | GT9883_0004_fm10.book |
| Document Creator | FrameMaker 10.0.2 |
| Document Author: | 10014848 |
INSTALLATION MANUAL INSTRUCTIONS ENDOSCOPE REPROCESSOR Labels and Symbols Important Information — Please Read Before Use Chapter 1 Checking the Package Contents 17 Chapter 2 Nomenclature and Functions 21 Chapter 3 Installation of Accessories 37 Chapter 4 Installation of Equipment 49 OER-Elite¥ Installation Work Check Points For information on how to operate this equipment, please refer to “Instructions - Operation Manual”. 191 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 Ensuring the safety of reprocessing personnel .................................................................... 11 Equipment compatibility ....................................................................................................... 12 Signal words ........................................................................................................................ 12 Warnings and cautions ........................................................................................................ 12 Outline of Functions ........................................................................................................ 14 Chapter 1 Checking the Package Contents ....................................... 17 1.1 Checking the package contents ............................................................................ 17 Chapter 2 Nomenclature and Functions ............................................ 21 2.1 Front panel .............................................................................................................. 21 2.2 Top panel ................................................................................................................. 22 2.3 Inside ....................................................................................................................... 23 2.4 Rear panel ............................................................................................................... 24 2.5 Side panel ................................................................................................................ 25 2.6 Reprocessing basin ............................................................................................... 26 2.7 Control panels ........................................................................................................ 28 Touch screen – Menu Screen .............................................................................................. 29 Touch screen – Reprocessing standby screen .................................................................... 30 Touch screen – Reprocessing process screen .................................................................... 32 2.8 Consumable accessories (Optional) .................................................................... 33 Chapter 3 Installation of Accessories ................................................ 37 3.1 Installation of accessories workflow below ......................................................... 37 3.2 Installation of the grommets ................................................................................. 38 3.3 Installation of the buckling guard ......................................................................... 39 3.4 Inspection of the mesh filters ............................................................................... 40 3.5 Inspection of the retaining rack ............................................................................ 41 3.6 Installation of the washing case (MAJ-2121) ....................................................... 42 3.7 Installation of the stylus pen holder ..................................................................... 43 Required items .................................................................................................................... 43 Installing the stylus pen holder ............................................................................................ 43 3.8 Inspecting the accessory holder .......................................................................... 44 OER-Elite INSTALLATION MANUAL Contents 3.9 Storing other accessories ...................................................................................... 44 3.10 Installation of the optional accessories ............................................................... 45 Connection of the bar code reader (MAJ-2130) .................................................................. 45 Installation of the printer set (MAJ-2144) ............................................................................. 46 Chapter 4 Installation of Equipment ................................................... 49 4.1 General flow of installation of the equipment ...................................................... 49 4.2 Installation workflow .............................................................................................. 52 4.3 Installation conditions ............................................................................................ 54 Installation condition ............................................................................................................ 54 Checking the installation position ........................................................................................ 57 4.4 Connection of the water supply hose ................................................................... 58 4.5 Connection of the drain hose ................................................................................ 60 4.6 Connection of the power supply ........................................................................... 64 4.7 Confirmation of the power supply ........................................................................ 66 4.8 Inspection of the RFID function ............................................................................ 69 4.9 Setting the date and time ....................................................................................... 74 4.10 Installation of the gas filters (MAJ-822) ................................................................ 79 Required items .................................................................................................................... 79 Attachment of the gas filter case to the lid ........................................................................... 80 Attachment of the gas filter case to the disinfectant solution tank ....................................... 83 4.11 Installation of the air filter (MAJ-823) .................................................................... 90 Required items .................................................................................................................... 90 Installing the air filter ............................................................................................................ 91 4.12 Inspection of air leakage from the air filter connectors ...................................... 96 4.13 Installation of the water tray .................................................................................. 99 4.14 Installation of the water filter (MAJ-824 or MAJ-2318) ...................................... 100 Required items .................................................................................................................. 101 Attachment of the water filter ............................................................................................. 101 4.15 Correction of equipment tilt ................................................................................ 113 Adjustment if water level is not located within even one of the three ranges ..................... 117 Correcting the tilt ................................................................................................................ 118 4.16 Inspecting the detergent/alcohol inner tray ....................................................... 121 4.17 Inspecting the alcohol tank ................................................................................. 122 4.18 Addition of alcohol ............................................................................................... 123 4.19 Installation of the detergent tank ........................................................................ 126 Required items .................................................................................................................. 127 Installing the detergent tank .............................................................................................. 127 4.20 Setup of the disinfectant solution ....................................................................... 134 Required items .................................................................................................................. 136 Setup of the disinfectant solution ....................................................................................... 136 ii OER-Elite INSTALLATION MANUAL Contents 4.21 Self disinfection and check the operation ......................................................... 145 Self-disinfection and check the operation workflow ........................................................... Required items .................................................................................................................. Checking the MRC level and entering the check result ..................................................... Performing the self disinfection ......................................................................................... When the “Message 093” is displayed .............................................................................. When the “Message 087” is displayed .............................................................................. 146 146 147 154 159 160 4.22 Water line disinfection ......................................................................................... 162 Disinfection of water supply piping workflow ..................................................................... Required items .................................................................................................................. Checking the MRC level and entering the check result ..................................................... Disinfecting the water line .................................................................................................. 164 164 164 172 4.23 Checking the operation of optional accessories .............................................. 180 Checking the operation of the bar code reader (MAJ-2130) ............................................. 180 Checking the operation of the printer (MAJ-1937) ............................................................. 186 Installation Work Check Points ........................................................... 191 Installation work check points ...................................................................................... 191 OER-Elite INSTALLATION MANUAL iii Contents iv OER-Elite INSTALLATION 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 equipment are as follows: Symbol Description Refer to instructions. Endoscope reprocessor Manufacturer Authorized representative in the European Community Lot number Serial number Safety-related labels and symbols are attached to the equipment at the locations shown below. If labels or symbols are missing or illegible, contact Olympus. OER-Elite INSTALLATION 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 INSTALLATION 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 INSTALLATION MANUAL Labels and Symbols Rear panel CSA/UL MARKING OER-Elite INSTALLATION 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 INSTALLATION MANUAL Labels and Symbols Reprocessing basin Fonts displayed on the touch screen Ricoh bitmap fonts designed by RICOH Company, Ltd. are used. OER-Elite INSTALLATION 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 subject to cleaning by the user prior to reprocessing; however, use of the OER-Elite enables the user to perform modified manual cleaning of the endoscope prior to automated cleaning and high-level disinfection in the OER-Elite. Instruction manuals The instructions for this equipment 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 equipment safely and effectively. The “Instructions-Installation Manual” describes how to install the equipment. The “Instructions-Operation Manual” describes how to operate and maintain the equipment 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 equipment 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 INSTALLATION 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 equipment 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 equipment is stopped by the operator or due to an error, it identifies its status and executes the optimum operation automatically. For example, if the device 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 “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 equipment that enable it to perform ultrasonic cleaning and detergent cleaning of endoscopes. OER-Elite INSTALLATION 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 equipment 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 equipment. When an error code is displayed, check the troubleshooting guide. LCG Stands for 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 equipment 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 simplified due to subsequent use of the OER-Elite which automates cleaning steps in the process. MRC Stands for Minimum Recommended Concentration. Patient ID Identify 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” in “Instructions-Operation manual”. 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” in “Instructions-Operation manual”. OER-Elite INSTALLATION MANUAL Important Information — Please Read Before Use Portable memory A digital medium for storage. Precleaning Cleaning of an endoscope performed after each procedure at the bedside of the endoscopy room. Procedure ID Identify 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” in “Instructions-Operation manual”. Process Generic term for any operation, including cleaning and disinfection that is performed automatically by this equipment. 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 histories of reprocessing, etc. For the scope ID input method, refer to Section 3.6, “Entering ID” in “Instructions-Operation manual”. 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” in “Instructions-Operation manual”. 10 OER-Elite INSTALLATION MANUAL Important Information — Please Read Before Use Ensuring the safety of reprocessing personnel • Disinfectant solution may irritate the mucous membranes in the eyes and respiratory organs. If disinfectant solution contacts directly on the skin, it may cause irritation or damage. Therefore, before handling high-level disinfectant solution, and detergent, carefully read the instructions for use and the material safety data sheet. For further details, contact Olympus. • During reprocessing, wear appropriate personal protective equipment to prevent contact with or inhalation of infectious substances or disinfectant. 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 is not exposed. All personal protective equipment 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 equipment 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 performing the inspection or maintenance exhibits an allergic reaction or symptoms no matter how slight they should discontinue the task and vacate the room. • Before handling the detergent or disinfectant, read the MSDS (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 equipment. • This equipment 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 equipment 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. OER-Elite INSTALLATION MANUAL 11 Important Information — Please Read Before Use Equipment compatibility Use this equipment in combination with ancillary equipment listed in “System chart” in “Instructions-Operation Manual”. Using incompatible equipment may interfere with the proper operation of this equipment and could lead to personal injury and/or equipment damage. Olympus has not tested the efficacy of cleaning and high-level disinfection on this equipment in combination with endoscopes that are not listed on the “List of compatible Endoscopes/Connecting Tubes ”. 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 equipment. 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 equipment. Also, do not allow any liquid (including water or disinfectant solution) to flow into an opening. Contact with an electrical part inside the equipment could cause an electric shock or equipment 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 equipment and contact an electrical part inside, causing an electric shock or fire hazard. 12 OER-Elite INSTALLATION MANUAL Important Information — Please Read Before Use WARNING • Do not install this equipment in any place where any of the following are present. High oxygen concentration Oxidizing substance such as Nitrous Oxide (N2O) Flammable anesthetic gas This equipment is not explosion-proof and may explode or cause a fire under these conditions. • Always use the power cord provided with this equipment. Otherwise, equipment failure or power cord burnout may result. Also, remember that the provided power cord is for use only with this equipment and should not be used with any other equipment. CAUTION • Do not press any of the switches on the control panel of this equipment 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 equipment at the end of the day to avoid potential water leaks. • To avoid malfunctions, do not use this equipment in a dusty environment. • To avoid electromagnetic interference from other equipment, do not install any other electrical devices in close proximity to this equipment (aside from ancillary devices used with this equipment). • This equipment enables radio communication by RFID and emits RF (radio frequency:13.56MHz) 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 INSTALLATION MANUAL 13 Outline of Functions Outline of Functions Following functions are available in this device. Reprocessing A series of operations that enable the equipment 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” in “Instructions-Operation manual”. Drain LCG This function drains the disinfectant solution from the disinfectant tank. For details, refer to Section 8.2, “Replacing the disinfectant solution” in “Instructions-Operation manual”. Load LCG This function loads the disinfectant solution by setting a new disinfectant bottle. For details, refer to Section 8.2, “Replacing the disinfectant solution” in “Instructions-Operation manual”. Heat LCG A process for heating disinfectant solution until it reaches the specified temperature. 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” in “Instructions-Operation manual”. Heat LCG Timer The function for heating the disinfectant solution until the specified temperature by the specified time. For details, refer to Section 7.3, “Heat LCG Timer” in “Instructions-Operation manual”. Mix LCG This function is mixing the disinfectant solution to the appropriate concentration concentration and enables accurate concentration check. 14 OER-Elite INSTALLATION MANUAL Outline of Functions Water line disinfection This function disinfects the water supply line and other lines inside the equipment. For details, refer to Section 7.7, “Water line disinfection” in “Instructions-Operation manual”. Self disinfection and water sampling This function disinfects the basin and internal piping of the equipment. At the 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” in “Instructions-Operation manual”. Detergent/Alcohol line disinfection This function disinfects the detergent line and alcohol line of the equipment. For details, refer to Section 7.9, “Detergent line disinfection” in “Instructions-Operation manual” and Section 7.10, “Alcohol line disinfection” in “Instructions-Operation manual”. 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” in “Instructions-Operation manual”. 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” in “Instructions-Operation manual”. 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” in “Instructions-Operation manual”. 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” in “Instructions-Operation manual”. OER-Elite INSTALLATION MANUAL 15 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” in “Instructions-Operation manual”. 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” in “Instructions-Operation manual”. ALT self-check This function diagnoses the auto leak test function of the device. 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” in “Instructions-Operation manual”. 16 OER-Elite INSTALLATION MANUAL 1.1 Checking the package contents Chapter 1 1.1 Checking the Package Contents Ch.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 INSTALLATION MANUAL 17 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 equipment 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) 18 OER-Elite INSTALLATION MANUAL 1.1 Checking the package contents Accessories preattached to the equipment 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) Ch.1 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 INSTALLATION MANUAL 19 1.1 Checking the package contents Scope ID master card (GT970700) User ID master card (GT970600) Accessory for use in record management Ch.1 Portable memory (MAJ-1925) Manuals Instructions-Installation Manual (this manual) Instructions-Operation Manual OER-Elite Quick Reference Guide OER-Elite Operation Guide 20 OER-Elite INSTALLATION 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 equipment ON or OFF. Power indicator Lights up when the equipment 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 equipment. 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 INSTALLATION MANUAL 21 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 for removing the odor and vapor of the disinfectant solution. Ventilation openings on the This is the hole for taking and exhausting air into/from the reprocessing basin. Do gas filter case not block the ventilation openings on the gas filter case. 22 OER-Elite INSTALLATION MANUAL 2.3 Inside 2.3 Inside 11 Ch.2 10 No. Nomenclature Description Gas filter case (tank) Accommodates the gas filter for removing the odor and vapor of the disinfectant solution. Ventilation opening on the gas filter case This is the hole for taking and exhausting 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 INSTALLATION MANUAL 23 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 equipment 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. 24 OER-Elite INSTALLATION 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 INSTALLATION MANUAL 25 2.6 Reprocessing basin 2.6 Reprocessing basin 22 19 21 20 Ch.2 18 17 16 10 11 15 12 14 13 23 26 OER-Elite INSTALLATION 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 equipment is level. OER-Elite INSTALLATION MANUAL Ch.2 27 2.7 Control panels 2.7 Control panels Ch.2 No. Nomenclature Description Touch screen Used to control and set the equipment. Also, the information and state of the equipment 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. 28 OER-Elite INSTALLATION MANUAL 2.7 Control panels Touch screen – Menu Screen The menu consists of six buttons according to the classification of the equipment’s Functions into six categories. Select the desired category here. No. Name Ch.2 Description Reprocessing Press this button to display the Reprocessing Standby screen. oRefer to Section 6.5, “Basic operation for reprocessing” in “Instructions-Operation manual”. Log Press this button to go to Log menu. oRefer to Section 11.1, “Log menu” in “Instructions-Operation manual”. Functions Press this button to go to Function menu. oRefer to Section 7.1, “Function menu” in “Instructions-Operation manual”. Settings Press this button to go to Setting menu. oRefer to Section 4.1, “Setting menu” in “Instructions-Operation manual”. 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” in “Instructions-Operation manual”. Information Press this button to go to Information menu. oRefer to Chapter 12, “Information Menu Screen” in “Instructions-Operation manual”. NOTE The operational buttons are expressed by a box with gradation. Figure 2.1 OER-Elite INSTALLATION MANUAL 29 2.7 Control panels Touch screen – Reprocessing standby screen Select the program by pressing the program selection buttons. Ch.2 10 10 11 12 No. 13 11 14 Nomenclature 12 13 14 Description Scope 1 button Goes to the ID information screen associated with the first endoscope. Model number of scope 1 Displays the model number of the first endoscope. It is blank when the Scope ID is not entered. ID status of scope 1 Displays the input status of patient ID, physician ID, user ID, and procedure ID associated with the first scope. Scope 2 button Goes to the ID information screen associated with the second endoscope. Model number of scope 2 Displays the model number of the second endoscope. It is blank when the Scope ID is not entered. ID status of scope 2 Displays the input status of patient ID, physician ID, user ID, and procedure ID associated with the second scope. Program selection button Press these buttons to select the reprocessing program. Program number display Displays the selected reprocessing program number. For details of the reprocessing program number, refer to “Reprocessing Program” on the next page. Process time Displays the process time of the selected reprocessing program. If the scope ID is inputed with one of the following four methods, the reprocessing time of programs extend 3 minutes. The scope ID of the endoscope with forceps elevator The scope ID master card Input from the software keyboard Recalling the pre-registerd ID 10 Alcohol flush indicator 11 Heat LCG indicator Indicate that the Heat LCG is incorporated in the reprocessing program. Heat LCG cannot be eliminated from the reprocessing process. 12 Menu button Returns to the Menu screen, 13 LCG Info. button Goes to the LCG info. screen. 30 Indicate that the Alcohol Flush is incorporated in the reprocessing program. Alcohol flush cannot be eliminated from the reprocessing process. OER-Elite INSTALLATION MANUAL 2.7 Control panels No. 14 Nomenclature Description MRC Check Result Goes to the MRC Check Result entry screen. button Ch.2 No. Nomenclature Program information Description Displays information about the selected reprocessing program. Cln. Displays the cleaning time Dis. Displays the disinfecting time. Channel Monitor indicator If “PCM” is displayed, channel monitor is executed in the cleaning and disinfection process. If “FCM” is displayed, channel monitor is executed in the cleaning, disinfection and rinsing process. Auto Leak Test indicator If “ALT ON” is displayed, auto leak test is incorporated in the reprocessing process. If “ALT OFF” is displayed, auto leak test is not incorporated in the reprocessing process. Display LCG Info. Button Press to display the disinfectant solution information on the area of No.1. Refer to No.3. LCG information Displays information about the current disinfectant solution. LCG Cycle Count Usage count of the disinfectant solution. LCG Usage Number of days that have elapsed since preparation of the disinfectant solution. LCG Temp Temperature of disinfectant solution during reprocessing process. MRC Check Result Input result of MRC check. Display Program Info. button Press to display the information of the selected reprocessing program on the area of No.3. Refer to No.1. OER-Elite INSTALLATION MANUAL 31 2.7 Control panels Touch screen – Reprocessing process screen 10 11 Ch.2 12 No. 13 14 Nomenclature 15 Description Scope 1 button Press this button to display the ID information associated with first endoscope. Model number of scope 1 type Displays the model number of the first endoscope. It is blank when the scope ID is not entered. ID status of scope 1 Displays the input status of patient ID, physician ID, user ID, and procedure ID associated with the first endoscope. Scope 2 button Press this button to display the ID information associated with the second endoscope. Model number of scope 2 Displays the model number of the second endoscope. It is blank when the scope ID is not entered. ID status of scope 2 Displays the input status of patient ID, physician ID, user ID, and procedure ID associated with the second endoscope. Program number Displays the selected reprocessing program number. Remaining time Displays the remaining time of a reprocessing process. Process progress bar Displays progress of the reprocessing process. 10 Current process name Displays the process being executed. 11 Temperature Displays the temperature of fluid in the reprocessing basin. 12 Menu button During the reprocessing process, it cannot be operated with this button. 13 LCG Info. button Press this button to display the LCG Info. screen. 14 MRC Check Result button During the reprocessing process, it cannot be operated with this button. 15 LCG Info./Program information button Press this button to display the reprocessing program information about the selected reprocessing program. 32 OER-Elite INSTALLATION MANUAL 2.8 Consumable accessories (Optional) 2.8 Consumable accessories (Optional) Water filter (MAJ-824 or MAJ-2318) WARNING Before using consumable items, be sure to check its expiration date instructed in the labeling of consumable items. If these items are expired, effectiveness of items may be compromised. Internal 0.2 micron water filter. Figure 2.2 Gas filters (MAJ-822) Incorporated in the gas filter cases to absorb disinfectant odors and vapors. Figure 2.3 OER-Elite INSTALLATION MANUAL 33 Ch.2 2.8 Consumable accessories (Optional) Air filter (MAJ-823) Filters microorganisms and fine particles in the air fed into the equipment. Ch.2 Figure 2.4 Olympus-validated detergent Figure 2.5 Name Type Manufacturer Remarks EndoQuick Alkaline detergent Best Sanitizers, Inc (154 Mullen Drive, Walton, KY) 2.8 L disposable tank for use in OER-Elite Table 2.1 NOTE EndoQuick is distributed by Olympus America, Inc. To obtain EndoQuick listed above, contact Olympus. 34 OER-Elite INSTALLATION MANUAL 2.8 Consumable accessories (Optional) Olympus-validated concentrated disinfectant solution (1,065 ml cassette bottles) Ch.2 Figure 2.6 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 INSTALLATION MANUAL 35 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 2.7 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. 36 OER-Elite INSTALLATION MANUAL 3.1 Installation of accessories workflow below Chapter 3 Installation of Accessories Set up the equipment and ancillary equipment as required while referring to the “System chart” in the “Instructions-Operation Manual”. Also, refer to the instruction manual for the ancillary equipment and follow the instructions below to install and connect the equipment and ancillary equipment. 3.1 Installation of accessories workflow below See the installation of accessories workflow below. Install the grommets. Install the bucking guard. Inspect the mesh filter. Inspect the retaining rack. Install the washing case (MAJ-2121). Install the stylus pen holder. Inspect the accessory holder. Ch.3 Section 3.2 on page 38 Section 3.3 on page 39 Section 3.4 on page 40 Section 3.5 on page 41 Section 3.6 on page 42 Section 3.7 on page 43 Section 3.8 on page 44 OER-Elite INSTALLATION MANUAL 37 3.2 Installation of the grommets Store other accessories. Section 3.9 on page 44 Connect the optional accessories. • Install the optional bar code reader (MAJ-2130)on page 45 • Install the optional printer set (MAJ-2144)on page 46 3.2 Ch.3 Installation of the grommets Insert two grommets into the grommet attaching holes on each sides of the reprocessor (four grommets in total). CAUTION Be sure to attach the grommets. Otherwise, fluid may penetrate the grommet attaching holes and cause equipment damage. Figure 3.1 38 OER-Elite INSTALLATION MANUAL 3.3 Installation of the buckling guard 3.3 Installation of the buckling guard The buckling guard helps maintain proper drainage by preventing the drain hose from being crushed if the instrument is pushed too close to a wall, etc. CAUTION Be sure to securely attach the buckling guard using the buckling guard retaining screws. If the screws are not properly attached, the buckling guard may become detached, allowing the drain hose and power cord to be pinched against the wall and causing problems such as water discharge failure. Ch.3 Align the holes on the buckling guard with the screw holes threaded on the rear panel and attach using the three buckling guard retaining screws. Bucking guard Figure 3.2 OER-Elite INSTALLATION MANUAL 39 3.4 Inspection of the mesh filters 3.4 Inspection of the mesh filters The mesh filters are used to prevent the penetration of debris into the equipment and endoscope channels. CAUTION • If the mesh filters have been removed, be sure to put them back in their original positions before using the equipment. If you forget to attach the mesh filters, the pump may malfunction and/or foreign objects may clog the endoscope channels including the nozzle. • After removing any of the mesh filters, be sure to reinstall them in their original locations before using the equipment. Otherwise, debris may clog the endoscope channels and nozzles or the pumps may fail. Ch.3 • If a mesh filter is dropped or impacted in any way, ensure that it is not damaged. Damaged mesh filters may not perform adequately. • Two-type mesh filters are installed on the outer and inner sides of the circulation port. Be sure to remove, inspect, and clean both of them. Step on the foot pedal to open the lid. Check that the drain port mesh filter and two circulation port mesh filters are attached inside the reprocessing basin. Circulation port mesh filters Drain port mesh filter Figure 3.3 40 OER-Elite INSTALLATION MANUAL 3.5 Inspection of the retaining rack 3.5 Inspection of the retaining rack The retaining rack is used to hold the endoscopes in the specified position for reprocessing. WARNING Attach the retaining rack correctly. If the retaining rack is not attached properly, the washing case and endoscopes cannot be set properly and the endoscopes may not be adequately reprocessed. Make sure the retaining rack is attached properly to the reprocessing basin and that the ring of the retaining rack fits onto the projection on the temperature sensor. Ch.3 Temperature sensor Ring of retaining rack Figure 3.4 OER-Elite INSTALLATION MANUAL 41 3.6 Installation of the washing case (MAJ-2121) 3.6 Installation of the washing case (MAJ-2121) The washing case is used to hold the endoscope valves in the specified position for reprocessing. WARNING • Do not use the washing case if any abnormality is found with it. If an abnormal washing case is used, the reprocessing may become insufficient. • Be sure to attach the washing case properly. Otherwise, endoscope reprocessing may not be effective. • Place the washing case in the washing case holder of the retaining rack, washing case protrusion to fit on the cutout of washing case holder and ensure that it is centered on the washing case mount of the reprocessing basin. Otherwise the reprocessing may become insufficient. Ch.3 Cutout of Washing case holder Washing case holder Washing case mount Figure 3.5 42 OER-Elite INSTALLATION MANUAL Washing case mount Washing case protrusion 3.7 Installation of the stylus pen holder 3.7 Installation of the stylus pen holder The stylus pen offered is used to operate the touch screen of the OER-Elite. Required items Check Required items M4 × 10 mm cap bolt Hex wrench (GT804300) Ch.3 Stylus pen holder (RA016500) Stylus pen (GT944200) Table 3.1 Installing the stylus pen holder Align the two holes on the stylus pen holder with the screw holes on the right side panel of the equipment and secure it with two M4 × 10 mm cap bolts using the provided hex wrench. Figure 3.6 Place the stylus pen in to the stylus holder. OER-Elite INSTALLATION MANUAL 43 3.8 Inspecting the accessory holder 3.8 Inspecting the accessory holder Check if the accessory holder is attached securely with two screws to the inner side of the front door as shown in Figure 3.7. Check by turning the screws clockwise with your hands, and tighten them if they are loose. 3.9 Ch.3 Storing other accessories Accessories such as the connecting tubes can be hung on the accessory holder on the inner side of the front door. After reprocessing the accessories ensure that they are completely dry before storing them. Accessory holder Figure 3.7 44 Put the scope ID master card and user ID master card in the card holders and attach the card holder below the accessory holder on the inner side of the front door. Less frequently used accessories should be dried completely and then stored together in a place not exposed to dust or direct sunlight. OER-Elite INSTALLATION MANUAL 3.10 Installation of the optional accessories 3.10 Installation of the optional accessories Connection of the bar code reader (MAJ-2130) If the optional bar code reader (MAJ-2130) is connected to the equipment, the patient ID can be entered by the bar code reader. For details, refer to “ Entering the patient ID by the optional bar code” in Section 3.6, “Entering ID” in “Instructions-Operation Manual”. To install the bar code reader (MAJ-2130), refer to Chapter 3, “Installation and Connection” in “MAJ-2130 Instruction Manual”. WARNING Ch.3 • Do not stare into beam. It may cause damage to the eyes. • Do not irradiate people’s eyes with beam. It may cause damage to the eyes. CAUTION • Do not connect any other equipment with the bar code reader port except the bar code reader itself (MAJ-2130). Otherwise, the bar codes may not be scanned correctly. Also, equipment failure or burnout may result. • The communication cable should not be sharply bent, pulled, twisted, or crushed. Cable damage can result, and bar codes may not be properly scanned. Connecting diagram Bar code reader port Communication cable Bar code reader Figure 3.8 OER-Elite INSTALLATION MANUAL 45 3.10 Installation of the optional accessories Installation of the printer set (MAJ-2144) If the optional printer set (MAJ-2144) is connected to the equipment, the history of each process can printed. For details, refer to the instruction manual Section 6.10, “Printing of the reprocessing records” in “Instructions-Operation Manual”. To install the printer set (MAJ-2144), refer to Chapter 3, “Installation of the printer” in “MAJ-2144 Instruction Manual”. WARNING Do not bend the AC power cord forcibly, or place heavy objectives on the AC power cord. Doing so may damage the AC power cord and cause a fire or an electric shock. If the AC power cord is damaged, discontinue using it and contact Olympus. Ch.3 CAUTION • Do not connect any other power cord and any equipment the printer power outlet except the printer (MAJ-1937) AC power cord. Connecting anything other than the specified power cord may result in failure or burnout of the equipment. • Do not connect any other cable to the printer communication port except the interface cable intended to be used with printer (MAJ-1937). Connecting except the specified cable may result in failure or burnout of the equipment. • The interface cable should not be sharply bent, pulled, twisted, or crushed. Cable damage can result, and printer may not be properly communicated. 46 OER-Elite INSTALLATION MANUAL 3.10 Installation of the optional accessories Connecting diagram AC power cord (RU6517) attached to printer Printer outlet Printer communication port Ch.3 AC adapter (RU6518) attached to printer Printer MAJ-1937 Interface cable Figure 3.9 OER-Elite INSTALLATION MANUAL 47 3.10 Installation of the optional accessories Ch.3 48 OER-Elite INSTALLATION MANUAL 4.1 General flow of installation of the equipment Chapter 4 4.1 Installation of Equipment General flow of installation of the equipment Connect the water supply hose, drain hose and power cord to the equipment, and set up the required chemicals (disinfectant, detergent etc.). Be sure to clean the reprocessor before installation, since dust could accumulate on or in the machine under certain storage or transport conditions. Check that the external surface, bottom surface, and casters of the equipment are clean before installation. WARNING • Make sure to connect the power cord plug to the hospital-grade wall mains power outlet of your medical facility. Plug the power cord directly into a hospital-grade, wall mains power outlet and do not use a multiple outlet. This equipment must be grounded; otherwise, an electric shock or a fire may result. • Do not allow the power cord plug to get wet. A wet plug could cause an electric shock. • To prevent an electric shock, do not touch the power cord plug or directly touch the power source with wet hands. • When using disinfectant solution and alcohol, Olympus recommends the use of gas filters and running this equipment 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 equipment exhibits an allergic reaction or symptoms no matter how slight they should discontinue the task they are performing and vacate the room. OER-Elite INSTALLATION MANUAL 49 Ch.4 4.1 General flow of installation of the equipment WARNING • Do not push the rear end of equipment against a wall after connecting the power cord plug. The power cord may break and result in an electric shock or a fire. • Make sure that the hospital-grade, wall mains power outlet of your medical facility meets the power specifications required by this unit. Insufficient capacity could result in a fire or activation of the facility’s circuit breakers, which will turn off the power to all other equipment connected to the same power source. • Use the power cord plug supplied with the equipment. Using a different power cord plug may result in equipment malfunction or power cord burnout. Additionally, do not use the supplied power cord plug on any other equipment as it is specified to be used only with this equipment. CAUTION • To prevent fluid leakage, do not attempt to extend the water supply hose and drain hoses. Ch.4 • To prevent fluid leakage or damage, do not bend the water supply hose and drain hose or apply external force to them. • To prevent discharge failure, cut off any excess drain hose and coil in such a manner as to prevent it from bending or kinking. • To prevent discharge failure, always leave the drain hose tip open to the air inside the floor drain (the hose tip should not be immersed in liquid and the inside of the floor drain should be open to the air). • If the water supply capacity drops below the minimum required flow rate and pressure levels, the equipment may stop with an error, the process time may be prolonged. When the water supply capacity pressure and flow rate is low, improve the water supply by installing a booster pump, etc. • If the water supply pressure (shut-off pressure) exceeds 0.5 MPa, contact Olympus to request pressure reducing materials. • Do not supply water with a temperature over 28qC (82qF), as this can cause the equipment or endoscope to deteriorate. • Although the reprocessor incorporates a water filter, it may still fail or the water filter use life may be reduced if the water contains a large amount of debris and sediment. If this is the case, contact Olympus to have a strainer installed in the water supply piping. 50 OER-Elite INSTALLATION MANUAL 4.1 General flow of installation of the equipment CAUTION • The disinfectant solution’s waste fluid should be treated in accordance with the instructions supplied with the disinfectant solution. It is recommended the waste fluid be treated and drained or disposed of according to local wastewater standards defined by law, or to temporarily collect and store the waste fluid and have it treated by a waste disposal firm. • Do not install the equipment in a place exposed to direct sunlight or where the temperature exceeds 40qC (104qF). Otherwise, the equipment may malfunction or the disinfectant solution may not last as long. • Do not place objects on or apply excessive force to the equipment. Doing so could damage or deform the lid. • Before installing the equipment, ventilate the room. Otherwise, the ancillary equipment may malfunction. • Do not install equipment in a way that would make it difficult to disconnect the power cord plug from the wall mains power outlet. Otherwise, power shutdown by disconnecting the power cord plug cannot be performed in case of malfunction or failure of the equipment. • Before installing the equipment, be sure to check that the installation meets the conditions provided in Section 4.3, “Installation conditions”. If not, water leaks, malfunction, or failure of the equipment may result. OER-Elite INSTALLATION MANUAL 51 Ch.4 4.2 Installation workflow 4.2 Installation workflow See the installation workflow below. Install the equipment. Connect the water supply hose. Connect the drain hose. Connect the power supply cord. Confirm the power supply. Inspect the RFID function. Set the date and the time. Install the gas filters. Install the air filter. Section 4.3 on page 54 Section 4.4 on page 58 Section 4.5 on page 60 Ch.4 10 52 Section 4.6 on page 64 Section 4.7 on page 66 Section 4.8 on page 69 Section 4.9 on page 74 Section 4.10 on page 79 Section 4.11 on page 90 Inspect air leakage from the air filter connectors. Section 4.12 on page 96 OER-Elite INSTALLATION MANUAL 4.2 Installation workflow 11 Install the water filter. 12 Correct equipment tilt. 13 Inspect the detergent/alcohol inner tray. 14 Inspect the alcohol tank. 15 Addition of alcohol. 16 Install of the detergent tank. 17 Set up the disinfectant solution. 18 Check the functions. 19 Disinfect the water supply piping. 20 Check the functions of the optional accessories. Section 4.14 on page 100 Section 4.15 on page 113 Section 4.16 on page 121 Section 4.17 on page 122 Ch.4 Section 4.18 on page 123 Section 4.19 on page 126 Section 4.20 on page 134 Section 4.21 on page 145 Section 4.22 on page 162 Section 4.23 on page 180 OER-Elite INSTALLATION MANUAL 53 4.3 Installation conditions 4.3 Installation conditions To ensure safe use of this equipment, be sure to observe the following conditions. Installation condition Installation location conditions • The floor should be able to support a weight of 200 kg (440 lb) (50 kg per caster). • The provided water supply hose (3 m/9.8 ft) and drain hose (3 m/9.8 ft) should be able to reach the water faucet and floor drain. • The power cord (3.5 m/11.5 ft) should be able to reach the power outlet. Ch.4 • The equipment should not be exposed to direct sunlight. • The location should be clean and free of dirt or dust. • The ambient temperature should be between 10qC (50qF) and 40qC (104qF). • The elevation above sea level should not exceed 3,000 m (9,842 ft) • The equipment should be used indoors. • When using the disinfectant solution, and alcohol, Olympus recommends the use of gas filters and running this equipment 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 performing the inspection or maintenance exhibits an allergic reaction or symptoms no matter how slight they should discontinue the task and vacate the room. 54 OER-Elite INSTALLATION MANUAL 4.3 Installation conditions Water supply conditions • Potable water, softened water, or pure water can be used. • The water hardness should not exceed 400 ppm. The recommended water hardness is 150 ppm 1 or lower. • The water supply quantity at water supply/circulation nozzle on the reprocessing basin should be 6 liters per minute (1.6 gallon per minute) or more when the water faucet is fully open. The recommended water supply quantity is 18 liters per minute (4.8 gallons per minute) or more. NOTE The process time is extended if the water supply amount is lower than 18 liters per minute. • The water supply pressure should be between 0.1 and 0.5 MPa (Include water hammer). • The water temperature should be between 5qC (41qF) and 28qC (82qF). Ch.4 • The water should not contain rust, dirt, or other foreign matter. *1 The recommended value is in reference to AAMI TIR34: 2014 “Water for the reprocessing of medical devices”. Drain conditions • The top of the drain hose should be no higher than 60 cm. A floor drain is recommended. • The diameter of the drain piping of the facility should be 36 mm (1.4 in) or more (a 100 mm (3.9 in) pipe is desirable). • The drain capacity of the floor drain should be 50 liters per minute (13.3 gallons per minute) or more (this capacity should be maintained until all of the fluids in the reprocessing basin are drained). • The floor drain should be connected to a waste fluid treatment or pooling facility. • The specification of drain above is for one unit of the equipment. When using more than one unit in your facility, a larger size of floor drain will be required. Power supply conditions • Power supply capacity should be enough for the equipment rating (120 V AC, 5.5 A, 60 Hz, voltage fluctuations within ±10%, frequency fluctuations within ±1 Hz). • The power outlet should be a hospital-grade, wall mains power outlet (3-conductor, grounded). OER-Elite INSTALLATION MANUAL 55 4.3 Installation conditions Equipment dimensions and minimum wall clearances Buckling guard 500 mm (19.7 in) Min. rear clearance 50 mm (1.9 in) (Projection of buckling guard) Bar code reader Connector hanger Top Printer set Drain hose (3 m) (9.8 ft) 800 mm (31.5 in) Max. projection 774 mm (30.5 in) Power cord (3.5 m) (11.5 ft) Water supply hose (3 m) (9.8 ft) Top 42 mm (1.6 in) 88 mm (3.5 in) 156 mm (6.2 in) 28 mm (1.1 in) Ch.4 273 mm (10.7 in) 1423 to 1723 mm (56.0 to 67.8 in) Connector hanger Min. side clearances 30 mm (1.2 in) (50 mm (1.9 in) when connector hanger is installed 120 mm (4.7 in) when bar code reader is installed 190 mm (7.1 in) when printer set is installed) Lid Bar code reader 1582 mm (62.2 in) Buckling guard 1172 mm (46.1 in) Right side Front 945 mm (37.2 in) Rear Power cord connector 165 mm (6.4 in) 92 mm (3.6 in) Figure 4.1 56 OER-Elite INSTALLATION MANUAL Drain hose connector 180 mm (7.0 in) 67 mm (2.6 in) 4.3 Installation conditions Checking the installation position Place the equipment on a flat, level floor surface. NOTE The tilt of the equipment will be corrected in Section 4.15, “Correction of equipment tilt”. Open the front door and press the foot pedal to open the lid. Make sure that the door and the cover do not come into contact with other equipment or with the walls. Ch.4 OER-Elite INSTALLATION MANUAL 57 4.4 Connection of the water supply hose 4.4 Connection of the water supply hose The water supply plug of this equipment is designed to be connected to an ordinary tap water faucet with 3/4” GHT (garden hose thread), or the Olympus Pre-Filter Assembly (MF01-0033PL). If a different type of the water faucet is used, have a plumber enable a safe and secure connection. Make sure that there is a packing inside of the water supply plug. Packing Ch.4 Figure 4.2 Fit the water supply plug onto the water faucet and turn it clockwise to tighten with the provided wrench. The pitch of the thread of the water supply plug is “3/4” garden hose thread (GHT). Figure 4.3 While pushing a finger against the lock lever on the water supply socket, pull the sleeve down toward the hose and fit the socket onto the water supply plug. Release the lock lever ensuring that it hooks onto the outer ring of the plug as pictured in Figure 4.4. (2) (1) (3) Figure 4.4 58 OER-Elite INSTALLATION MANUAL 4.4 Connection of the water supply hose After confirming that the lock lever is engaged, pull the hose lightly to make sure the connection is tight. Figure 4.5 CAUTION Connect the connection ring on the equipment 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. Align the connection ring on the equipment end of the water supply hose with the water supply hose connector on the rear right of the reprocessing basin so the hose does not hinder the opening and shutting of the lid, and turn the connection ring clockwise to tighten. Connection ring on the equipment end Figure 4.6 Open the water faucet slowly while checking to make sure that water does not leak from the hose connection area. If water leaks, close the water faucet and reconnect the water supply hose. OER-Elite INSTALLATION MANUAL 59 Ch.4 4.5 Connection of the drain hose 4.5 Connection of the drain hose WARNING • Do not bend the drain hose or position it in such a way that it kinks and obstructs access to the floor drain hole. Otherwise, discharge will be incomplete and the endoscope may not be properly cleaned and disinfected. • Connect the connection ring of the drain hose to the drain hose connection port on the rear (bottom right) of the equipment by tightening securely. An insecure connection may lead to a risk of a solution leak. CAUTION • Fix the other end of the drain hose firmly inside the facility’s floor drain hole. Otherwise, the drain hose may come out of the hole due to the discharge pressure resulting in fluid overflow. Ch.4 • Install the drain hose so that its maximum height is 60 cm (23 in) or less. Otherwise, discharge failure may cause the equipment to malfunction. Align the connection ring of the drain hose with the drain hose connector on the rear (bottom right) of the equipment and turn the ring clockwise to tighten it. Figure 4.7 Insert the other end of the drain hose into the drain hole on the floor and secure it so that it does not come out of the drain hole during discharge. NOTE If the drain hose is too long, cut it to an appropriate length. 60 OER-Elite INSTALLATION MANUAL
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