Olympus Medical Systems GN4215 Endoscope Reprocessor with RFID User Manual Manual P1 P114
Olympus Medical Systems Corp. Endoscope Reprocessor with RFID Manual P1 P114
Contents
- 1. Users Manual 1
- 2. Users Manual 2
- 3. Users Manual 3
- 4. Users Manual 4
Users Manual 1
INSTRUCTIONS ENDOSCOPE REPROCESSOR OER-Pro (For Aldahol III) For details on installation and setup, refer to “Instructions - Installation Manual”. USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician. Contents Contents Labels and Symbols ..................................................................... Important Information — Please Read Before Use.................... Intended use ............................................................................................. Instruction manuals ................................................................................... User qualifications..................................................................................... Ensuring the safety of reprocessing personnel ......................................... Equipment compatibility ............................................................................ 10 Care and storage ...................................................................................... 10 Maintenance and administration ............................................................... 10 Repair and modification ............................................................................ 10 Disposal of waste fluids............................................................................. 11 Disposal of this equipment ........................................................................ 11 Signal words.............................................................................................. 11 Dangers, warnings, and cautions.............................................................. 12 Terms used in these manuals ................................................................... 14 Chapter 1 Checking the Package Contents............................ 16 Chapter 2 Nomenclature and Functions ................................. 20 2.1 Front and top panel......................................................................... 20 2.2 Rear panel ...................................................................................... 22 2.3 Side panel ....................................................................................... 22 2.4 Cleaning tub.................................................................................... 23 2.5 Control panels................................................................................. 24 2.6 Consumable accessories (Optional) ............................................... 29 Inspection Before Use............................................. 32 Inspecting for water leakage from the water supply piping and within the equipment ................................................................ 34 Chapter 3 3.1 3.2 Inspecting the equipment’s connectors........................................... 35 3.3 Inspecting the connecting tubes and leak test air tube ................... 36 3.4 Inspecting the remaining quantity of detergent, and replenishment 37 3.5 Inspecting the remaining quantity of alcohol, and replenishment ... 43 3.6 Inspecting the mesh filters .............................................................. 48 3.7 Inspecting for disinfectant solution odor.......................................... 49 3.8 Inspecting the disinfectant solution’s concentration level ............... 50 3.9 Inspecting the printer paper roll ...................................................... 53 ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Contents Chapter 4 Basic Endoscope Reprocessing Operations ........ 54 4.1 Power activation and opening the faucet ........................................ 57 4.2 Inspection before use...................................................................... 60 4.3 Endoscope precleaning .................................................................. 60 4.4 Recognition of the Scope ID ........................................................... 61 4.5 User ID detection ............................................................................ 64 4.6 Endoscope setup ............................................................................ 66 4.7 Leak test ......................................................................................... 72 4.8 Connecting tube installation ............................................................ 78 4.9 Reprocessing .................................................................................. 80 4.10 Alcohol flushing ............................................................................... 87 4.11 Removing the endoscopes ............................................................. 94 4.12 Printing of the reprocessing results................................................. 95 Chapter 5 5.1 Turning the power OFF, closing the faucet and cleaning the outer surface ............................................................................. 110 5.2 Cleaning the mesh filters................................................................. 111 5.3 Removal or storage of alcohol ........................................................ 113 5.4 Cleaning the fluid level sensor ........................................................ 116 Chapter 6 ii End-of-Day Checks.................................................. 109 Other Functions ....................................................... 119 6.1 Confirming the disinfectant solution temperature............................ 119 6.2 Heating the disinfectant solution ..................................................... 120 6.3 Setting the reprocessing programs ................................................. 122 6.4 Setting the disinfectant solution counter ......................................... 126 6.5 Display of the total number of times the disinfectant solution was supplied........................................................................................... 131 6.6 Display the total operation count of the equipment ......................... 131 6.7 Air purge ......................................................................................... 132 6.8 Rinsing ............................................................................................ 133 6.9 Emergency stop and automatic processing after stopping ............. 134 ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Contents Chapter 7 Routine Maintenance .............................................. 136 7.1 Replacing the gas filter (MAJ-822).................................................. 138 7.2 Replacing the water filter (MAJ-824)............................................... 142 7.3 Disinfecting the water supply piping................................................ 152 7.4 Microbiological surveillance ............................................................ 160 7.5 Replacing the air filter (MAJ-823) ................................................... 165 7.6 Cleaning the float switch ................................................................. 168 7.7 Checking the lid and lid packing ..................................................... 170 7.8 Cleaning the detergent/alcohol drawer ........................................... 171 7.9 Cleaning the detergent tank............................................................ 172 7.10 Cleaning the accessories and accessory holders........................... 173 7.11 Cleaning the alcohol tank................................................................ 175 7.12 Replacing the disinfectant solution ................................................. 176 7.13 Cleaning the mesh filter in the water supply adapter connector ..... 193 7.14 Replacing the fuse .......................................................................... 195 7.15 Disinfecting the detergent/alcohol pipe ........................................... 196 7.16 Preparing the reprocessor for long-term storage ............................ 204 7.17 Installing the printer paper roll......................................................... 211 7.18 Care and maintenance after long-term storage .............................. 217 Chapter 8 Troubleshooting and Repair................................... 218 8.1 Troubleshooting guide .................................................................... 218 8.2 Returning the endoscope reprocessor for repair ............................ 227 Appendix ....................................................................................... 228 System chart ............................................................................................. 228 Shipping environment ............................................................................... 230 Operating environment.............................................................................. 230 Specifications ............................................................................................ 230 EMC information ....................................................................................... 233 ENDOSCOPE REPROCESSOR OER-Pro Operation Manual iii Contents iv ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Labels and Symbols Labels and Symbols The meaning(s) of the symbol(s) shown on the package with the components, the back cover of this instruction manual and/or this equipment are as follows: Refer to instructions. Caution, hot surface Endoscope reprocessor Manufacturer Authorized representative in the European Community ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Labels and Symbols Safety-related labels and symbols are attached to the equipment at the locations shown below. If labels or symbols are missing illegible, contact Olympus. Front panel RFID marking ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Labels and Symbols Top panel Rotation direction indicator label Indicates the rotation directions for locking and releasing each gas filter case. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Labels and Symbols Inner side ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Labels and Symbols Rotation direction indicator label Indicates the rotation direction for locking and releasing each gas filter case. Error code table Lists error codes, possible causes, and remedial actions for details, see Section 8.1, “Troubleshooting guide” on page 218 in the “Instructions-Operation Manual”. Rating plate Shows the product model, power rating, and serial number. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Labels and Symbols Rear panel CSA/UL MARKING Option terminal Used for connecting ancillary equipment (for service engineer use only). ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Important Information — Please Read Before Use Important Information — Please Read Before Use Intended use This subject device has been designed to wash and disinfect flexible endoscopes and their accessories utilizing an alkali detergent and an FDA-approved liquid chemical germicide for semi critical medical devices. Both the detergent and the LCG are exclusively used for this subject. Instruction manuals The instructions for this equipment are divided into two volumes: “Instructions-Installation Manual” and “Instructions-Operation Manual”. Each manual contains essential information for using this equipment safely and effectively (“Instructions-Installation Manual” describes how to install the equipment and “Instructions-Operation Manual” describes how to inspect and use the equipment. These manuals will be referred to as “the instruction manuals”.). Before using this reprocessor, be sure to review these manuals thoroughly, as well as the manuals of any other equipment that will be used during reprocessing. Always, use this equipment as instructed. It might cause unexpected danger if you don't follow the installation and operation manual. The descriptions in these manuals assume that all endoscopes are reprocessed using the Olympus-designated detergent (EndoRapid 980 ml pack) and disinfectant solution (Aldahol III). Keep these and all related instruction manuals and documents in a safe, accessible location. If you have any questions or comments about any information in these manuals, please contact Olympus. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Important Information — Please Read Before Use User qualifications The operator of this equipment must be sufficiently trained in reprocessing of endoscopes. 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 the detailed cleaning, disinfection, and sterilization procedures. For more details, please consult your facility's procedures, professional guidelines, and regulatory requirements for reprocessing endoscopes. Ensuring the safety of reprocessing personnel • Before handling the high-level disinfectant solution (Aldahol III), carefully read the instructions for use and the material safety data sheet. • During reprocessing, wear appropriate personal protective equipment to prevent contact with or inhalation of infectious substances or disinfectant. Personal protective equipment includes eye wear, 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. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Important Information — Please Read Before Use • When using the disinfectant solution and alcohol, Olympus recommends the use of gas filters and running this equipment in well-ventilated areas. Wear a facemask, 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) Do not handle the equipment if the operator shows any allergic symptoms even while wearing protective gear. • Before handling the detergent or disinfectant, read the 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 function. Please be aware that the radio waves emitted from the equipment may cause medical devices such as pacemakers to malfunction. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Important Information — Please Read Before Use Equipment compatibility Use this equipment in combination with ancillary equipment listed in “System chart” in Appendix. Using incompatible equipment may result in patient or operator injury and equipment damage and/or malfunction. Care and storage After use, reprocess and store this equipment referring to the instructions in Chapter 5, “End-of-Day Checks” in this manual. Inappropriate care and storage could present an infection control risk and/or cause equipment damage or malfunction. Maintenance and administration • Endoscopes or ancillary devices that have been used many times or for a long time are more likely to fail. In addition to checks before use, the person in charge of maintenance and administration of the medical equipment at the hospital should periodically check all of the items described in this manual. If any irregularity is observed, do not use the equipment and inspect it as described in 8.1, “Troubleshooting guide” on page 218. If the irregularity is still present, the equipment must be repaired prior to next use. • If the lamp of the PERIODICAL MAINTENANCE indicator described in Section 2.5, “Control panels” on page 24 blinks, contact Olympus. Repair and modification Do not disassemble, modify or attempt to repair this equipment 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 8, “Troubleshooting and Repair”. If the problem cannot be resolved using the information in Chapter 8, “Troubleshooting and Repair”, contact Olympus. 10 ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Important Information — Please Read Before Use Disposal of waste fluids The waste fluids of this equipment should be treated as directed in the Aldahol III instruction manuals and follow all applicable national and local guidelines. Disposal of this equipment When disposing of this equipment and accessories, follow all applicable national, state, and local regulations and guidelines. Signal words The following signal words are used throughout these manuals: Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. 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. Indicates additional helpful information. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 11 Important Information — Please Read Before Use Dangers, warnings, and cautions Follow the dangers, warnings, and cautions given below when handling this equipment. This information is supplemented by the dangers and warnings given in each chapter. • 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. • 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 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. 12 • Do not press any of the switches on the main or subcontrol panel of this equipment with a pointed or hard object. Otherwise, the switch may be damaged. • Be sure to turn off the faucet and the power switch of the equipment at the end of the day. Otherwise, water supply hose might slip off the connection when not in use (e.g., nighttime or holidays) because of the unexpected change in water pressure. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Important Information — Please Read Before Use • 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 provides a radio communication function by RFID and emits RF (Radio Frequency) energy to perform the said intended functions. Therefore, it may cause electromagnetic interference in nearby electronic equipment, and is labeled with the following symbol. 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. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 13 Important Information — Please Read Before Use Terms used in these manuals Cleaning fluid Refers to the water treated by the water filter for use by this equipment in reprocessing. When cleaning fluid is used in the detergent cleaning process, detergent is added to it. Detergent Olympus-designated alkaline detergent (EndoRapid). Disinfectant solution Olympus-designated disinfectant solution (Aldahol III). Alcohol 70% ethyl alcohol or isopropyl alcohol. Process Generic term for any operation, including cleaning and disinfection, that is performed automatically by this equipment. Cleaning process A series of operations programmed into the equipment that enable it to perform ultrasonic cleaning and detergent cleaning of an endoscope. Disinfection process A series of operations programmed into the equipment that enable it to perform disinfection of an endoscope. Leak test A test to confirm that an endoscope is waterproof. Air purge In this operation, air is fed into an endoscope channel to blow out any internal moisture. 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. 14 ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Important Information — Please Read Before Use Reprocessing programs A series of operations for ultrasonic cleaning, detergent cleaning, disinfection, and rinsing of the outer surface and channels of endoscopes that run in a specified sequence and for a specified time. Reprocessing programs [1] to [3] can be selected by the user. Program [1] consists of a preset series of processes confirmed as effective at our factory. Programs [2] and [3] can be set up by the user. Alcohol flushing To dry the channel after reprocessing, alcohol is passed through the endoscope channel and then air is fed through. This operation can be performed as the last step after completion of the reprocessing program or as an independent operation. Disinfectant solution heating A process for heating disinfectant solution until it reaches the appropriate temperature. When this process is included in a reprocessing program, it is performed automatically during the program. It can also be performed as an independent operation. Test strip Device used to test if the concentration of disinfectant solution is effective for disinfection. Meets the minimum recommended concentration (MRC) specified by the disinfectant manufacturer. Error code A code consisting of [E] and a two-digit number. This code is displayed on the main control panel if there is a problem with the equipment. When an error code is displayed, check the error code list to find out what corrective measures to take. 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 disinfection process, it terminates the disinfection process and removes the disinfectant solution. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 15 Chapter 1 Checking the Package Contents Chapter 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. Accessories for use in installation Buckling guard (GT143100) Buckling guard retaining screws (u3) (GC783700) Grommet (u4) (GC784100) Wrench (GC748400) ENDOSCOPE REPROCESSOR OER-Pro Power cord (DW662000) Drain hose (GJ853400) Water supply adapter (GN513000) Accessories for use in reprocessing Gas cap 1 Connecting tubes (u 2) (MAJ-1501) Connecting tubes (u 2) (MAJ-1500) 16 Not used with OER-Pro. Leak test air tubes (u 2) (MAJ-821) ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Chapter 1 Checking the Package Contents Accessories to be attached to the equipment Gas filter cases (u 2) (GJ460700) Gas filters (u 2) (MAJ-822) Adapter (GC949900) Washing case (MAJ-827) Paper roll axle (MAJ-1498) Air filter (MAJ-823) printer paper roll (MAJ-1497) Water filter (MAJ-824) Water tray (GC601400) Accessories pre-attached to the equipment Alcohol tank (GN042300) Detergent tank (GJ457500) Circulation port mesh filters (GC574000, GC693900) Retaining rack (GL830600) Detergent/alcohol inner tray (GT115400) Drain port mesh filter (GC220100) ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 17 Chapter 1 Checking the Package Contents Accessories for use in maintenance Tube (GC651300) Syringe (GT173600) Filter tubes (u 2) (GJ460500) Disinfectant collection hose (GJ668000) Sampling tube (GN513100) Water filter wrench (GC601300) Drain connector (GL366300) Connector jig (GN312400) Spare fuses (u 2) (DB181500) Card holders (u 2) (GT271000) 18 Scope ID master card (GT210400) Disinfectant removal tube (GJ460200) Water supply piping disinfection hose (GL860800) User ID master card (GT210300) ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Chapter 1 Checking the Package Contents Manuals Instructions-Installation Manual OER-Pro Quick Reference Guide Instructions-Operation Manual (this manual) OER-Pro Operation Guide DVD List Of Compatible Endoscopes/Connecting TubesEndoscope Reprocessor Information Card ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 19 Chapter 2 Nomenclature and Functions Chapter 2 Nomenclature and Functions 2.1 Front and top panel Water supply adapter Supplies municipal water for use in cleaning. Water supply adapter connector Connect the water supply adapter here. A mesh filter is built in. ID reader section Reads the user ID and scope ID. Printer Prints information such as the scope ID of the reprocessed scope and the reprocessing time. Detergent/alcohol drawer Accommodates the specially designed tanks of detergent for cleaning and alcohol for alcohol flushing. Main control panel Used mainly to start or stop the reprocessing processes. Power switch Press to switch the power ON/OFF. The green light is lit when the equipment is ON. Subcontrol panel Used for various setups and operations. Detergent indicator Indicates the amount of residual detergent. Alcohol indicator Indicates the amount of residual alcohol. Front door Push the area marked “PUSH” to open. 20 Disinfectant bottle drawer Accommodates disinfectant cassette bottles. This drawer cannot be opened when using Aldahol III. Contact Olympus for information. Casters The two front casters have lock mechanisms. The caster heights can be adjusted to level the equipment. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Chapter 2 Nomenclature and Functions Gas filters (cases) Accommodates the gas filters for removing the odor and vapor of the disinfectant solution. Connector above water filter housing Disinfectant indicator Used to check the amount of remaining disinfectant solution. For use in draining water and air from the water filter housing. Water filter (housing) Accommodates the water filter inside. The water filter is used to remove microorganisms and fine particles in the water. Accessory holder Used to store the connecting tubes, etc. Card holders Hold the scope ID master card and user ID master card. Connector below water filter housing For use in draining water from the water filter housing. Air filter Filters the supply air. Water tray Collects water during maintenance such as the water filter replacement. Maintenance terminal Used for connecting ancillary equipment (for service engineer use only). Disinfectant removal port Used to check the disinfectant manufacturer's recommended concentration or drain the disinfectant solution (Remove the rubber cap and attach the drain connector the disinfectant removal tube). ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 21 Chapter 2 Nomenclature and Functions 2.2 Rear panel Buckling guard attaching holes Screw holes used to attach the buckling guard. Option terminal Used for connecting ancillary equipment (for service engineer use only). Drain hose connector Fuses 2.3 Power cord receptacle Side panel Connector hanger attaching holes (Provided on both left and right side panels) Used to attach the optional connector hanger (MAJ-865). Grommet attaching holes (Provided on both left and right side panels) Used to attach the grommets. 22 ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Chapter 2 Nomenclature and Functions 2.4 Cleaning tub Lid Step the foot pedal to open the cover. Foot pedal Press to open the lid. It is locked during the reprocessing process. Circulation port Aspirates the cleaning fluid or disinfectant solution for circulation during cleaning or disinfection. Water supply/circulation nozzle Supplies water for cleaning and washing. Also supplies the cleaning fluid or disinfectant solution aspirated through the circulation port for circulation. Air/water/instrument channel connector (Gray) Connect a connecting tube that is connected to the endoscope here. Water supply piping disinfection connector Connect the water supply piping disinfection hose here. Auxiliary water/forceps elevator connector (Yellow) Connect a connecting tube that is connected to the endoscope here. Disinfectant solution nozzle Leak test connector (Black) Supplies disinfectant solution to the cleaning tub. Connect the leak test air tube that is connected to the endoscope. Float switch Detects abnormal fluid levels in the cleaning tub. Drain port Drains liquid from the cleaning tub and supplies disinfectant solution. Detergent nozzle Supplies detergent to the cleaning tub. Water level scales (u 3) Markings for confirming that the equipment is level. Fluid level sensor Detects the fluid level in the cleaning tub to control it. Temperature sensor Washing case mount For use in detergent heating. Attach the Washing case that is used to hold the endoscope accessories including valves for reprocessing. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 23 Chapter 2 Nomenclature and Functions 2.5 Control panels Main control panel Main control panel User ID recognition indicator The lamp lights when the user ID is recognized. Add detergent indicator The lamp blinks when the detergent tank becomes empty. The error code [E95] is also displayed. Scope ID recognition indicators The lamp lights when the scope ID is recognized. Disinfectant replacement indicator The lamp blinks when the number of times or days of disinfectant usage reaches the set value. Periodical maintenance indicator This lamp blinks when it is time for regularly scheduled maintenance. When the lamp blinks, contact Olympus. TIME/CODE display Displays the remaining time and execution time of the process, etc. An error code is displayed in case of an error. Process step indicators The lamps included in the program being selected light up. Each lamp blinks when its corresponding process is being executed. Program No. display Displays the program number being selected. “E” is displayed in case of an error. Disinfectant solution heating indicator This lamp lights when the disinfectant solution heating operation is set for the program being selected. The lamp blinks during the disinfection process and goes out after completion. PROG button LEAK TEST button Press this button to select a reprocessing program. Press the button to add the leak test process. ALC FLUSH button Press this button to add the alcohol flushing process. This function cannot be added once the reprocessing process has started. 24 STOP/RESET button Press this button to stop a process or clear an error code. START button Press this button to start the program. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Chapter 2 Nomenclature and Functions Subcontrol panel Subcontrol panel INFO FUNCTION The lamp corresponding to the selected function lights. For details, see “FUNCTION” on page 26. The lamp corresponding to the selected information lights and the details are displayed. For details, see “INFO” on page 27. INFO SEL button Press this button to select the information to be displayed. FUNC SEL button Press this button to select a function. Set “ ”/“ ” buttons Press these buttons to set the program details, date, and time. FUNC START button Press this button to start the selected function. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 25 Chapter 2 Nomenclature and Functions FUNCTION PRINT LAST Prints information about the previous reprocessing operation, such as the scope ID and cleaning time. For details, see Section 4.12, “Printing of the reprocessing results” on page 95. PRINT TODAY Prints details on all reprocessing operations carried out during the day, including scope IDs and cleaning time. For details, see Section 4.12, “Printing of the reprocessing results” on page 95. PRINT ALL Prints details on up to the last 60 reprocessing operations, including scope IDs and cleaning time. For details, see Section 4.12, “Printing of the reprocessing results” on page 95. HEAT LCG Heats the disinfectant solution before starting the disinfection process. For details, see Section 6.2, “Heating the disinfectant solution” on page 120. DRAIN LCG Drains the disinfectant solution from the disinfectant solution tank. For details, see Section 7.12, “Replacing the disinfectant solution” on page 176. LOAD LCG Supplies the disinfectant solution from the cleaning tub. For details, see Section 7.12, “Replacing the disinfectant solution” on page 176. DIS LINES Disinfects the water supply piping as well as the inside of the equipment. For details, see Section 7.3, “Disinfecting the water supply piping” on page 152. LEAK TEST Performs a leak test on the endoscope. For details, see Section 4.7, “Leak test” on page 72. 26 ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Chapter 2 Nomenclature and Functions ALC FLUSH Performs alcohol flushing of the endoscope channel. For details, see Section 4.10, “Alcohol flushing” on page 87. AIR PURGE Feeds air into the equipment and endoscope channels to drain residual water. For details, see Section 6.7, “Air purge” on page 132. RINSE Rinses the inside of the equipment and endoscope. For details, see Section 6.8, “Rinsing” on page 133. INFO WASH/CYCLE display Pressing the information select button changes the information displayed on the subcontrol panel as shown in Table 2.1. DIS/DAY display Pressing the information select button changes the information displayed on the subcontrol panel as shown in Table 2.1. TEMP qC display Pressing the information select button changes the information displayed on the subcontrol panel as shown in Table 2.1. PROGRAM INFO LCG USAGE WASH/CYCLE display DIS/DAY display TEMP qC display Cleaning time Disinfection time Temperature 1 Cycles Days –– TOTAL LCG 6-digit display LOADS TOTAL CYCLES 6-digit display YY/MM/DD Year Month Day H:MIN:SEC Hour Minute Second 1 Any temperature equal to or higher than 20qC (68qF) is displayed as “20qC” (68qF). “[- -]” is displayed there is not enough disinfectant solution in the disinfectant tank to measure the temperature. Table 2.1 ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 27 Chapter 2 Nomenclature and Functions PROGRAM INFO Displays the actual measured values for cleaning time, disinfection time, and temperature. LCG USAGE Displays the number of times or days the disinfectant solution has been used. TOTAL LCG LOADS Displays the total number of times that disinfectant solution has been loaded (6 digits). TOTAL CYCLES Displays the total number of times that the equipment was used (6 digits). YY/MM/DD Displays the year, month, and day. H:MIN:SEC Displays the hour (24 hour system), minute, and second. 28 ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Chapter 2 Nomenclature and Functions 2.6 Consumable accessories (Optional) Water filter (MAJ-824) Filters microorganisms and fine particles in the water. Gas filters (MAJ-822) Incorporated in the gas filter cases to remove the odor of disinfectant solution. Air filter (MAJ-823) Filters microorganisms and fine particles in the air fed into the equipment. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 29 Chapter 2 Nomenclature and Functions EndoRapid 980 ml pack (Olympus-designated detergent) The OER-Pro exclusive alkaline detergent. Available as a 980 mL pack. Aldahol III (Olympus-designated disinfectant solution) Test strip Test paper for use in checking the effective concentration of the Aldahol III High-level Disinfectant. 30 ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Chapter 2 Nomenclature and Functions Printer paper roll (MAJ-1497) Exclusive print sheet for the OER-Pro ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 31 Chapter 3 Inspection Before Use Chapter 3 Inspection Before Use To ensure that this equipment operates safely and reliably, inspect and clean all parts before use. Also, check all consumables and replace or replenish as necessary. Check Inspection items before the first use of the day 3.1 Inspecting for water leakage from the water supply piping and within the equipment 3.2 Inspecting the equipment’s connectors 3.3 Inspecting the connecting tubes and leak test air tube 3.4 Inspecting the remaining quantity of detergent, and replenishment 3.5 Inspecting the remaining quantity of alcohol, and replenishment 3.6 Inspecting the mesh filters 3.7 Inspecting for disinfectant solution odor Table 3.1 Check Inspection items before each reprocessing 3.8 Inspecting the disinfectant solution’s concentration level 3.9 Inspecting the printer paper roll Table 3.2 32 ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Chapter 3 Inspection Before Use • When using the disinfectant solution and alcohol, Olympus recommends the use of gas filters and running this equipment in well-ventilated areas. Wear a facemask, 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) Do not handle the equipment if the operator shows any allergic symptoms even while wearing protective gear. • Be sure to perform all inspections and replenish consumables as described in this chapter. Otherwise, the equipment may not work properly. • If any irregularity is observed during the inspections, do not use the equipment and contact Olympus. Using the equipment when an irregularity has been detected may impair operation of the equipment and could cause leakage, electric shock, burns, and/or fire. • During inspection, always wear appropriate personal protective equipment, such as eye wear, 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. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 33 Chapter 3 Inspection Before Use 3.1 Inspecting for water leakage from the water supply piping and within the equipment Confirm that water or fluid does not leak from the water supply piping, inside the equipment, Drain hose connector, etc. Do not continue using the equipment if it is leaking water. Doing so may result in an electric shock or malfunction. If water or fluid leaks from inside the equipment, close the faucet, set the power switch to OFF, unplug the power cord, and contact Olympus. 1. Slowly open the water supply faucet. 2. Confirm that water is not leaking from the connections on the water supply devices to the equipment: the faucet, the water supply hose, and the water supply adapter. 3. Confirm that water or fluid is not leaking from inside the equipment. If water leaks from the connections on the water supply devices to the equipment: the faucet, the water supply hose, and the water supply adapter 1. Close the faucet. 2. Check the installation of the water supply devices by referring to Section 4.2, “Connection of the water supply adapter” in “Instructions-Installation Manual”. If water leaks from the water filter housing 1. Close the faucet. 2. Check the installation of the water filter housing by referring to Section 3.9, “Installation of water filter (MAJ-824)” in “Instructions-Installation Manual”. If water or fluid leaks from inside the equipment 34 1. Close the faucet. 2. Set the power switch of the equipment to OFF. 3. Unplug the power cord from the power outlet. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Chapter 3 Inspection Before Use If water leaks from the Drain hose connector 3.2 1. Close the faucet. 2. Check the drain hose installation by referring to Section 4.3, “Connection of drain hose” in “Instructions-Installation Manual”. Inspecting the equipment’s connectors Check the following for each connector. The connector should be connected firmly. The O-rings should be free of abnormalities such as cracks, tears, or dents. If any irregularity is found, do not use the equipment and contact Olympus. Check Connectors in the cleaning tub Air/water/instrument channel connectors Auxiliary water/forceps elevator connectors Leak test connector Water supply piping disinfecting connector Table 3.3 Check Other connectors Connector above water filter housing Connector below water filter housing Disinfectant removal port Tube connector on detergent tank Tube connector on alcohol tank Table 3.4 Do not use the equipment if any connector seems to be damaged or defective. Using the equipment when an irregularity has been detected may interfere with reprocessing. Furthermore, fluid leakage may damage peripheral devices or facilities near the equipment. Connect each connector firmly by pushing until the connector clicks into place. After connection, pull the connector gently to confirm that it cannot be disconnected easily. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 35 Chapter 3 Inspection Before Use 3.3 Inspecting the connecting tubes and leak test air tube Before using the equipment, always check that there is no abnormality regarding the following points on the cleaning tubes and leak test air tube. All tubes should be free of cracks, breaks, fissures, scratches, or stains. There should be no cracks in the lock levers of connecting tube connectors. The tube should not be easy to disconnect once connected. Lock lever Figure 3.1 If a tube has any irregularities, do not use it and replace with a new one. Do not use the connecting tubes or leak test air tubes if they have any irregularities. Doing so could prevent effective reprocessing or damage the endoscope. 36 ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Chapter 3 Inspection Before Use 3.4 Inspecting the remaining quantity of detergent, and replenishment Check Required items EndoRapid 980 ml pack (Olympus-designated detergent) Table 3.5 Contact Olympus to obtain EndoRapid 980 ml packs (Olympus-designated detergent). Inspection of the amount of detergent Check the DETERGENT indicator on the detergent/alcohol drawer of the device to confirm that detergent is present. Add detergent as described in “Addition of detergent” before the level reaches “MIN.” or if the Add Detergent indicator lights up. Figure 3.2 • The detergent tank can hold about 2 L of detergent (which can be used for about 30 reprocessing operations). • If the reprocessing process is initiated without detergent, the error code [E95] is displayed and the reprocessing is stopped. The Add Detergent indicator on the main panel blinks. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 37 Chapter 3 Inspection Before Use Addition of detergent 38 • Before handling the detergent, read the precautions and instructions for use carefully, get fully accustomed to the content, and use the detergent as instructed. Make sure that you fully understand what measures need to be taken if you get any detergent on your skin. • Always use the EndoRapid 980 ml pack (Olympus-designated detergent). If a nondesignated detergent is used, the endoscope may not be properly cleaned or the predetermined sterilization effect may not be achieved. • When handling the detergent, always wear appropriate personal protective equipment, such as eye wear, 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. • To prevent the detergent from leaking, do not tilt the detergent tank when there is detergent inside. • If the reprocessing process is initiated without detergent, the error code [E95] is displayed and the reprocessing is stopped. The Add Detergent indicator on the main panel blinks. • Contact Olympus to obtain EndoRapid 980 ml packs (Olympus-designated detergent). • The detergent tank can hold about 2 L (67 ounces) of detergent (which can be used for about 30 reprocessing operations). ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Chapter 3 Inspection Before Use 1. Hold the section marked “PULL” of the detergent/alcohol drawer and pull it out. Figure 3.3 2. Push the lock lever on the connector of the tube connected to the detergent tank to detach the tube. Lock lever Detergent tank Figure 3.4 If a few drops of detergent drip from the connector, wipe it with a piece of clean gauze or similar cloth. 3. Remove the detergent tank and place it in a sink or other tub. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 39 Chapter 3 Inspection Before Use 4. Remove the rubber cap from the detergent inlet of the detergent tank. Detergent inlet Rubber cap Figure 3.5 5. Remove the cap from the EndoRapid 980 ml pack (Olympus-designated detergent) and attach the provided nozzle to it by turning the nozzle all the way in the direction shown in Figure 3.6. Nozzle Detergent pack Figure 3.6 40 ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Chapter 3 Inspection Before Use 6. • Do not add detergent when the tank is on the detergent/alcohol drawer. If detergent is spilled on the tray, this equipment may be damaged. • Do not push the center of the detergent pack with too much force while adding detergent. Otherwise, the detergent may spill out of the tank. • Do not tilt the detergent tank while there is still detergent inside. Otherwise, the detergent may spill. • Make sure that the nozzle provided with the detergent pack is connected firmly to the pack. Otherwise, the nozzle may get disconnected from the pack and detergent may leak as a result. Insert the end of the nozzle into the detergent inlet and add detergent. If any detergent spills out of the detergent tank, wash the outside of the tank, while taking care not to allow water to get in the tank. Wipe the tank dry with a clean cloth. Nozzle Detergent pack Detergent inlet Figure 3.7 ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 41 Chapter 3 Inspection Before Use 7. Attach the rubber cap to the detergent inlet of the detergent tank and ensure that detergent is not leaking from the detergent tank. 8. Place the detergent tank on the equipment’s detergent/alcohol drawer and connect the connector. Figure 3.8 9. Turn the connector to correct the tube orientation as shown below. Confirm that the tube is not bent. Connector Figure 3.9 10. 42 Close the detergent/alcohol drawer. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Chapter 3 Inspection Before Use 3.5 Inspecting the remaining quantity of alcohol, and replenishment Check how much alcohol is in the alcohol tank and add more as required. Check Required items 70% ethyl alcohol or isopropyl alcohol Table 3.6 • The alcohol used with the equipment should be 70% ethyl alcohol or isopropyl alcohol. Using any other kind of alcohol may result in malfunction of the equipment or the endoscope, difficulty drying the endoscope, or a hazard due to toxic vapor emitted from the alcohol. • Alcohol is flammable and should be handled with extra care. At the end of work, be sure to drain the alcohol from the tank or to remove the tank from the equipment and store it at a safe distance from the equipment. For more information on draining the alcohol or removing the alcohol tank, refer to Section 5.3, “Removal or storage of alcohol” on page 113 Leaving alcohol in the tank could pose a fire hazard. • Remove the alcohol in the alcohol tank and replace it with new alcohol at least once a week. Otherwise, the alcohol in the alcohol tank may degrade. • Before handling the alcohol, carefully read the precautions for use carefully, get fully accustomed to the content, and use the alcohol as instructed. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 43 Chapter 3 Inspection Before Use Inspection of the amount of alcohol Check the ALCOHOL indicator on the detergent/alcohol drawer of the equipment to confirm that alcohol is present. If the amount of alcohol has decreased, add alcohol as described in “Addition of alcohol” before the level reaches “MIN.”. Figure 3.10 If alcohol flushing is executed when no alcohol is present, the equipment will stop and display an error code [E93]. 44 ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Chapter 3 Inspection Before Use Addition of alcohol 1. Hold the section on the detergent/alcohol drawer marked “PULL” and pull it out. Figure 3.11 If the alcohol runs out, the equipment will stop and display an error code [E93]. 2. Push the lock lever on the connector of the tube connected to the cap on the alcohol tank to detach the tube. Lock lever Cap Alcohol tank Figure 3.12 3. Remove the alcohol tank and put it in a sink or other tub. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 45 Chapter 3 Inspection Before Use 4. Turn the cap on the alcohol inlet in the direction shown to remove the cap. Cap Alcohol inlet Figure 3.13 5. • Do not add alcohol while the tank is on the detergent/alcohol drawer. If alcohol is spilled on the tray, it could damage the equipment. • Do not tilt the alcohol tank while there is still alcohol inside. Otherwise, the alcohol may spill. Pour alcohol until it is level with the line inside the alcohol tank. Be careful not to spill any. If any alcohol spills from the tank, wipe it off with a clean cloth. After adding the alcohol, replace the cap on the alcohol tank. Line Figure 3.14 The amount of alcohol required to fill the tank up to the level of the line is about 500 mL (approximately 16 ounces, enough for about 10 alcohol flushes). 46 ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Chapter 3 Inspection Before Use 6. Place the alcohol tank in the detergent/alcohol drawer so that the ventilation tube of the alcohol tank sits on the front of the tray. Placing the alcohol tank so that the ventilation tube sits on the deeper side of the tray could damage the alcohol tank. 7. Connect the tube that was originally connected to the cap. Alcohol tank Ventilation tube Figure 3.15 8. Turn the connector to correct the tube orientation as shown below. Confirm that the tube is not bent. Connector Figure 3.16 9. Close the detergent/alcohol drawer. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 47 Chapter 3 Inspection Before Use 3.6 Inspecting the mesh filters Make sure that the circulation port mesh filters (two types) and the drain port mesh filter are not clogged. A clogged mesh filter not only prevents the equipment from functioning properly, but may also cause the endoscopes to malfunction or prevent effective reprocessing. • 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 enter the endoscope channels including the nozzle and clog them. • When cleaning the mesh filters, take care not to leave brush hair or cotton swab fiber in the meshes. Otherwise, their filtering effectiveness may be reduced. • If a mesh filter is dropped or subjected to an impact, make sure that the mesh shape is not deformed. Otherwise, the filtering effect may degrade. • 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. 1. Step the foot pedal to open the lid. 2. Remove the mesh filters from the cleaning tub. Drain port mesh filter Circulation port mesh filters Figure 3.17 3. 48 Check that the mesh filters are not clogged by a foreign object. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Chapter 3 Inspection Before Use 4. If any foreign object is found to be clogging the filter, clean the mesh filter in running water using a brush or cotton swab. Figure 3.18 5. 3.7 Attach the mesh filters in their original positions. Inspecting for disinfectant solution odor Check that the disinfectant solution is not producing an abnormal odor. Before handling the disinfectant solution, carefully read the precautions attached to the Aldahol III bottle and use as instructed. 1. Activate the room’s ventilation system. 2. Check that there is no abnormal disinfectant solution odor coming from the equipment or its surroundings. If the odor increases after replacement of the gas filters, contact Olympus. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 49 Chapter 3 Inspection Before Use 3.8 Inspecting the disinfectant solution’s concentration level Check the concentration of the disinfectant solution before reprocessing an endoscope, always check that the concentration of disinfectant solution is effective using the test strip. Be sure to replace the disinfectant solution before the disinfecting effect is lost. Check Required items Test strip (For Aldahol III) Drain connector (should be dry) Cup-shape container with a capacity of about 200 ml, such as a beaker (should be dry) Clean cloth Table 3.7 50 • The expiration of the disinfectant solution varies depending on many factors including the drain condition, the temperature of the environment where the equipment is installed. Routinely check the concentration of the disinfectant solution with the test strip before performing endoscope disinfection. If this check is not applied, disinfection may be insufficient. Also, be sure to replace the disinfectant solution before it becomes ineffective. • The container used in the following check, such as a beaker, and the drain connector should be completely dry. Residual moisture will affect the results. • Before handling the disinfectant solution, read the attached document for the disinfectant solution carefully, get fully accustomed to the content, and use the solution as instructed. Be sure to fully understand what to do if the disinfectant solution comes in contact with your skin. ENDOSCOPE REPROCESSOR OER-Pro Operation Manual Chapter 3 Inspection Before Use • When handling the disinfectant solution, wear appropriate personal protective equipment. To avoid adverse physical effects, be careful not to touch the disinfectant solution directly or to inhale too much vapor. 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 eye wear, 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. • Do not block the disinfectant removal port with a finger or other objects when the rubber cap is not attached. Otherwise, the disinfectant solution may flow out. • To prevent peripheral devices and facilities near the equipment from being damaged by leaked disinfectant solution, do not remove the rubber cap from the disinfectant removal port except when connecting the drain connector to the disinfectant removal port. • If disinfectant solution leaks out of the disinfectant removal port when the rubber cap has been removed, immediately reattach the rubber cap and follow the procedure in Section 8.1, “Troubleshooting guide” on page 218. If leaking does not stop, contact Olympus. To obtain test strip, contact Olympus. 1. Push [PUSH] on the front door to open the front door and remove the rubber cap from the disinfectant removal port. disinfectant removal port Rubber cap Figure 3.19 ENDOSCOPE REPROCESSOR OER-Pro Operation Manual 51
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