Operation Manual
300 Pages
Preview
Page 1
INSTRUCTIONS
ENDOSCOPE REPROCESSOR
OER-AW
For details on installation and setup, refer to “Instructions - Installation Manual”. for 220, 230, 240 V models only
Contents
Contents Labels and Symbols ...
1
Important Information - Please Read Before Use...
7
Intended use ...
7
Instruction manuals ...
7
User qualifications...
8
Ensuring the safety of reprocessing personnel ...
8
Equipment compatibility ...
10
Care and storage ...
10
Maintenance and administration ...
10
Repair and modification ...
11
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
Reprocessing basin ...
23
2.5
Control panels...
24
2.6
Consumable accessories (Optional) ...
29
Inspection Before Use...
33
Inspecting for water leakage from the water supply piping and within the equipment ...
35
3.2
Inspecting the lid and lid packing ...
36
3.3
Inspecting the equipment’s connectors...
37
3.4
Inspecting the connecting tubes and leak test air tube ...
38
3.5
Inspecting the remaining quantity of detergent, and preparation...
39
3.6
Inspecting the remaining quantity of alcohol, and replenishment ...
48
3.7
Inspecting the mesh filters ...
53
3.8
Inspecting for disinfectant solution odor...
54
3.9
Inspecting the disinfectant solution’s concentration level ...
55
3.10 Inspecting the printer paper roll ...
64
Chapter 3 3.1
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Contents
Chapter 4
Basic Endoscope Reprocessing Operations ...
65
4.1
Power activation and opening the water faucet ...
70
4.2
Inspection before use...
74
4.3
Endoscope precleaning and manual cleaning ...
74
4.4
Scope ID detection...
77
4.5
User ID detection ...
81
4.6
Endoscope setup ...
83
4.7
Leak test ...
96
4.8
Connecting tube installation ...
102
4.9
Reprocessing ...
106
4.10 Alcohol flushing ...
114
4.11 Removing the endoscopes ...
129
4.12 Printing of the reprocessing records ...
131
Chapter 5 5.1
Turning the power OFF, closing the water faucet, and cleaning the outer surface ...
150
5.2
Cleaning the mesh filters...
151
5.3
Cleaning the fluid level sensor ...
152
Chapter 6
ii
End-of-Day Checks... 149
Other Functions ... 155
6.1
Confirming the disinfectant solution temperature...
155
6.2
Heating the disinfectant solution ...
156
6.3
Setting the reprocessing programs ...
158
6.4
Setting the disinfectant solution counter ...
164
6.5
Display of the total number of times the disinfectant solution was supplied ...
169
6.6
Display the total operation count of the equipment ...
169
6.7
Air purge ...
170
6.8
Rinsing ...
171
6.9
Emergency stop and automatic processing after stopping ...
172
6.10 Print function setup ...
174
ENDOSCOPE REPROCESSOR OER-AW Operation Manual
Contents
Chapter 7
Routine Maintenance ... 180
7.1
Replacing the gas filter (MAJ-822)...
182
7.2
Replacing the water filter (MAJ-824)...
186
7.3
Disinfecting the water supply piping...
195
7.4
Microbiological surveillance ...
205
7.5
Replacing the air filter (MAJ-823) ...
210
7.6
Cleaning the float switch ...
212
7.7
Cleaning the detergent/alcohol drawer ...
214
7.8
Cleaning the detergent tank (This procedure is not applied when using disposable tank) ...
215
Cleaning the accessories and accessory holder...
216
7.10 Cleaning the alcohol tank...
218
7.11 Checking cassette cutters (This procedure is applied only when using 875 ml cassette bottles) ...
219
7.12 Cleaning the disinfectant bottle drawer (This procedure is applied only when using 875 ml cassette bottles) ...
219
7.13 Replacing the disinfectant solution ...
219
7.14 Cleaning the mesh filter in the water supply hose connector...
242
7.15 Replacing the fuse ...
243
7.16 Disinfecting the detergent/alcohol pipe ...
244
7.17 Preparing the reprocessor for long-term storage ...
252
7.18 Installing the printer paper roll...
259
7.19 Care and maintenance after long-term storage ...
265
7.9
Chapter 8
Troubleshooting and Repair... 267
8.1
Troubleshooting guide ...
267
8.2
Returning the endoscope reprocessor for repair ...
279
8.3
Printing function for troubleshooting ...
279
Appendix ... 281 System chart ...
281
Structure (Internal piping)...
283
Shipping environment ...
284
Operating environment...
284
Specifications ...
285
EMC information ...
289
ENDOSCOPE REPROCESSOR OER-AW Operation Manual
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Contents
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ENDOSCOPE REPROCESSOR OER-AW Operation Manual
Labels and Symbols
Labels and Symbols The meaning(s) of the symbol(s) shown on the component packaging, the back cover of this instruction manual, and/or this equipment are as follows:
Refer to instructions.
Caution, hot surface
Endoscope reprocessor
Manufacturer
Authorized representative in the European Community
Lot number
Serial number
Date of manufacture
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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
UDI label A label required by some countries’ regulations regarding identification of medical device also known as Unique Device Identification (UDI).
[[[[[[[[[[[[[[ [[[[[[ [[[[[[[
RFID marking
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ENDOSCOPE REPROCESSOR OER-AW Operation Manual
Labels and Symbols
Top panel
Rotation direction indicator label Indicates the rotation directions for locking and releasing each gas filter case.
CAUTION Place the detergent tank in the direction shown in the figure. Otherwise, there may be excessive strain on the tube when opening the detergent drawer. This may result in a damaged tube and subsequently, a detergent leak may occur.
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Labels and Symbols
Inner side
4
ENDOSCOPE REPROCESSOR OER-AW 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, refer to Section 8.1, “Troubleshooting guide” on page 267 in the “Instructions-Operation Manual”.
Rating plate Shows the product model, power rating, and serial number.
Date of manufacture
XXXX-XX-XX
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Labels and Symbols
Rear panel
Manufacturer, manufacturing site label
Crossed-out wheeled bin’s symbol (for 220, 230, 240 V models only)
CE plate (for 220, 230, 240 V models only)
For 220, 230, 240 V models For 110, 120 V models
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ENDOSCOPE REPROCESSOR OER-AW Operation Manual
Important Information - Please Read Before Use
Important Information - Please Read Before Use Intended use The OER-AW Endoscope Reprocessor is intended to clean and high-level disinfect Olympus flexible endoscopes and their accessories. Do not use the OER-AW for any purpose other than its intended use.
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”.) The “List of Compatible Endoscopes/Connecting Tubes <OER-AW>” identifies all Olympus model endoscopes that are compatible with the OER-AW, plus the specific connecting tube(s) required for each of these endoscope models. Before using this reprocessor, be sure to review these manuals thoroughly, as well as the manuals for any other equipment that will be used during reprocessing. Always, use this equipment as instructed. It might cause unexpected danger if you do not follow the installation and operation manual. The descriptions in these manuals assume that all endoscopes are reprocessed using the Olympus-designated detergent and disinfectant solution. 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, contact Olympus.
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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, consult your facility’s procedures, professional guidelines, and regulatory requirements for reprocessing endoscopes.
Ensuring the safety of reprocessing personnel
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•
Concentrated disinfectant solution in the 875 ml cassette bottles has a strong pungent smell that resembles acetic acid and irritates the mucous membranes in the eyes and respiratory organs, etc. if it gets on the skin, it may cause whitening or edema. Before handling this disinfectant, read the provided documentation and follow the instructions carefully.
•
Before handling the ready-to-use general high-level disinfectant solution, 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-AW Operation Manual
Important Information - Please Read Before Use
•
When using the disinfectant solution and alcohol, Olympus recommends the use of gas filters and enhanced protection by observing the following recommended ventilation conditions. Maintain the same conditions specified for glutaraldehyde vapor by the American SGNA (Society of Gastroenterology Nurses and Associates) guidelines.1 Wear a facemask, gloves, and protective clothes to minimize aspiration and skin contact. Wear goggles for eye protection. 1 (1) (2)
Use the disinfectant solution in a large room where the vapor can be diluted sufficiently. Fully replace the air 10 times per hour. In addition, reserve the air flow of 1 – 2 cubic feet (approximately 28,316 – 56,632 cm3) per square foot (approximately 929 cm2) per minute.
(3)
Ideally, the air discharge system should be located at the point where the vapor is produced. The system should be placed on the floor or on a workbench so that the operator does not breathe in the vapor.
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 (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.
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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. 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 <OER-AW>”. If a nonlisted endoscope is reprocessed using this equipment, be sure to validate in advance that entire part of endoscope including internal channels can be effectively cleaned and high-level disinfected, and it can maintain the function of the endoscope without damage or degradation. Furthermore, verify this reprocess method is appropriate for the endoscope.
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
10
•
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 267. If the irregularity is still present, the equipment must be repaired prior to next use.
•
If the lamp of the PERIODICAL MAINTENANCE indicator starts to blink, described in Section 2.5, “Control panels” on page 24, the time for regularly scheduled maintenance is near. When the lamp starts to blink, be sure to contact Olympus immediately and perform the maintenance. If you do not know when the lamp started to blink, do not use the device and contact Olympus. Otherwise, effectiveness of the reprocessing may be compromised.
ENDOSCOPE REPROCESSOR OER-AW Operation Manual
Important Information - Please Read Before Use
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.
Disposal of waste fluids The waste fluids of this equipment should be treated as directed in the instructions of the disinfectant solution 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.
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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 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.
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 water 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-AW 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-AW Operation Manual
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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 detergent. Disinfectant solution Olympus-designated concentrated disinfectant solution (875 ml cassette bottles) or ready-to-use disinfectant solution. Alcohol 70% ethyl or 70% isopropyl alcohol. Process Generic term for any operation, including cleaning and disinfection, which is performed automatically by this equipment. Cleaning process A series of operations programmed into the equipment that enables it to perform ultrasonic cleaning and detergent cleaning of an endoscope. Disinfection process A series of operations programmed into the equipment that enables it to perform disinfection of an endoscope. Leak test A test to confirm that an endoscope is free of leaks. 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.
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ENDOSCOPE REPROCESSOR OER-AW 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 runs in a specified sequence and for a specified time. Reprocessing programs [1] to [5] can be selected and set up by the user. Alcohol flushing To assist in drying 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 equipment stops in the middle of disinfection process, it terminates the disinfection process and removes the disinfectant solution.
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