Olympus OER-Elite Operation Manual
INSTRUCTIONS
ENDOSCOPE REPROCESSOR
OER-Elite¥
Labels and Symbols 1
Important Information — Please Read Before
Use 7
Chapter 1 Checking the Package Contents 19
Chapter 2 Nomenclature and Functions 23
Chapter 3 Basic Operation 35
Chapter 4 Settings 75
Chapter 5 Inspection and Preparation
Before Use 127
Chapter 6 Reprocessing Operations 147
Chapter 7 Functions 239
Chapter 8 Replacement of Consumable
Items 339
Chapter 9 Routine Maintenance 423
Chapter 10 End-of-Day Checks 451
Chapter 11 Log Management 463
Chapter 12 Information Menu Screen 589
Chapter 13 Troubleshooting and Repair 599
Appendix 647
For details on installation and setup, refer to “Instructions - Installation Manual”.
OPERATION MANUAL
Contents
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OER-Elite OPERATION MANUAL
Contents
Labels and Symbols .......................................................................................................... 1
Important Information — Please Read Before Use ......................................................... 7
Intended use .......................................................................................................................... 7
Instruction manuals ............................................................................................................... 7
Terms used in these manuals ................................................................................................ 8
User qualifications ................................................................................................................ 11
Ensuring the safety of reprocessing personnel ................................................................... 12
Equipment compatibility ....................................................................................................... 13
Care and storage ................................................................................................................. 13
Maintenance and Inspection ................................................................................................ 13
Repair and modification ....................................................................................................... 13
Disposal of disinfectant solution .......................................................................................... 14
Disposal of this reprocessor ................................................................................................ 14
Signal words ........................................................................................................................ 14
Warnings and cautions ........................................................................................................ 14
Outline of Functions ........................................................................................................ 16
Chapter 1 Checking the Package Contents ....................................... 19
1.1 Checking the package contents ............................................................................ 19
Chapter 2 Nomenclature and Functions ............................................ 23
2.1 Front panel .............................................................................................................. 23
2.2 Top panel ................................................................................................................. 24
2.3 Inside ....................................................................................................................... 25
2.4 Rear panel ............................................................................................................... 26
2.5 Side panel ................................................................................................................ 27
2.6 Reprocessing basin ............................................................................................... 28
2.7 Control panels ........................................................................................................ 30
2.8 Consumable accessories (Optional) .................................................................... 31
Chapter 3 Basic Operation .................................................................. 35
3.1 Turning power ON .................................................................................................. 35
3.2 Alarm indicator ....................................................................................................... 37
3.3 Control panel operation ......................................................................................... 40
3.4 Menu screen ........................................................................................................... 41
3.5 LCG Info. screen ..................................................................................................... 42
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3.6 Entering ID .............................................................................................................. 44
Entering through the RFID reader ....................................................................................... 45
Entering by the software keyboard ...................................................................................... 48
Entering the patient ID by the optional bar code ................................................................. 65
3.7 Checking the MRC level and entering the check result ...................................... 69
Required items .................................................................................................................... 70
Checking the MRC level ...................................................................................................... 70
Chapter 4 Settings ................................................................................ 75
4.1 Setting menu ........................................................................................................... 75
4.2 Auto leak test setting ............................................................................................. 79
4.3 MRC check setting ................................................................................................. 81
4.4 Manual cleaning and leak test setting .................................................................. 82
4.5 User ID Setting ........................................................................................................ 83
User ID setting (reprocessing) ............................................................................................. 84
User ID setting (functions and replacement) ....................................................................... 86
User ID setting (Heat LCG Timer) ....................................................................................... 87
4.6 Physician ID setting ............................................................................................... 88
4.7 Patient ID setting .................................................................................................... 89
4.8 Patient ID security setting ..................................................................................... 90
4.9 Procedure ID setting .............................................................................................. 91
4.10 Detergent replacement indicator .......................................................................... 92
4.11 Detergent lot number and shelf-life management ............................................... 94
4.12 LCG replacement indicator .................................................................................... 95
4.13 LCG lot number and shelf-life management ........................................................ 98
4.14 Filter replacement indicator .................................................................................. 99
4.15 Filter lot number management ............................................................................ 103
4.16 Auxiliary water tube cleaning setting ................................................................. 104
4.17 Print option ........................................................................................................... 106
Print format setting ............................................................................................................ 107
Auto Print Setting ............................................................................................................... 108
4.18 Start screen ........................................................................................................... 109
4.19 Connection guide ................................................................................................. 110
4.20 Volume and brightness ........................................................................................ 111
4.21 Date and time ........................................................................................................ 112
4.22 Temperature scale ................................................................................................ 115
4.23 Network setting ..................................................................................................... 116
4.24 Network security ................................................................................................... 121
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Chapter 5 Inspection and Preparation Before Use .......................... 127
5.1 Inspection before use .......................................................................................... 127
5.2 Flow of inspection ................................................................................................ 128
5.3 Inspecting the power activation .......................................................................... 129
5.4 Inspecting for fluid leaks ..................................................................................... 132
5.5 Inspecting the lid and lid packing ....................................................................... 133
5.6 Inspecting the connectors ................................................................................... 134
5.7 Inspecting the connecting tubes and leak test air tube ................................... 137
5.8 Inspecting the remaining detergent ................................................................... 138
5.9 Inspecting and replenishing alcohol .................................................................. 139
Inspection of the amount of alcohol ................................................................................... 140
Replenishing of alcohol ..................................................................................................... 140
5.10 Inspecting the mesh filters .................................................................................. 143
5.11 Inspecting the washing case (MAJ-2121) .......................................................... 144
5.12 Inspecting the labels on the reprocessing basin .............................................. 145
5.13 Inspecting for disinfectant solution odor ........................................................... 145
Chapter 6 Reprocessing Operations ................................................ 147
6.1 General flow of endoscope reprocessing using OER-Elite .............................. 147
6.2 Precleaning, leak testing, and manual cleaning ................................................ 148
Modified manual cleaning process for preparing endoscopes for processing in the
OER-Elite ........................................................................................................................... 149
Endoscope precleaning
(Procedure performed at bedside immediately after patient examination) ........................ 149
Endoscope precleaning continued
(Procedure performed at bedside immediately after patient examination) ........................ 150
Leakage testing ................................................................................................................. 152
Manual cleaning (procedure performed in reprocessing area) .......................................... 152
Loading the endoscope and their accessories into the OER-Elite .................................... 154
6.3 Reprocessing operation in the OER-Elite .......................................................... 155
Warnings ............................................................................................................................ 155
Outline of reprocessing operation in the OER-Elite ........................................................... 157
6.4 Worst case load condition of endoscopes and accessories ........................... 158
6.5 Basic operation for reprocessing ....................................................................... 160
Reprocessing standby screen ........................................................................................... 160
Reprocessing program ...................................................................................................... 162
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6.6 Loading of endoscopes and accessories .......................................................... 163
Outline of loading operation of endoscopes and accessories ........................................... 163
Input scope ID of first endoscope ...................................................................................... 165
Loading of first endoscopes in the reprocessing basin ...................................................... 166
Loading of the accessories of first endoscope (valves, etc.) ............................................. 173
Attaching the connecting tubes loading to first endoscope ............................................... 177
Loading of auxiliary water tube of first endoscope ............................................................ 186
Attaching the Leak test air tube loading to first endoscope ............................................... 189
Input connection information of first endoscope ................................................................ 194
Input results of manual cleaning and leak test of first endoscope ..................................... 195
Inputs user ID, physician ID, patient ID, and procedure ID of first endoscope .................. 196
Input scope ID of second endoscope ................................................................................ 197
Loading of second endoscopes in the reprocessing basin ................................................ 197
Loading of the accessories of second endoscope (valves, etc.) ....................................... 202
Attaching the connecting tubes loading to second endoscope .......................................... 205
Loading of auxiliary water tube of second endoscope ........................................................ 211
Attaching the Leak test air tube loading to second endoscope ......................................... 213
Input connection information of second endoscope .......................................................... 214
Input results of manual cleaning and leak test of second endoscope ............................... 214
Inputs user ID, physician ID, patient ID, and procedure ID of second endoscope ............ 214
Loading the stylus pen ....................................................................................................... 215
6.7 Inspection before starting reprocessing process ............................................. 216
6.8 Reprocessing ........................................................................................................ 220
Auto leak test ..................................................................................................................... 221
Channel monitoring ........................................................................................................... 223
Reprocessing operation ..................................................................................................... 225
6.9 Removing the endoscopes and accessories ..................................................... 228
6.10 Printing of the reprocessing records ................................................................. 232
Printing reprocessing results after completion of reprocessing ......................................... 234
Printing error code details in case of error ......................................................................... 237
Chapter 7 Functions ........................................................................... 239
7.1 Function menu ...................................................................................................... 239
Function menu ................................................................................................................... 239
7.2 Heat LCG ............................................................................................................... 242
7.3 Heat LCG Timer ..................................................................................................... 244
Flow of Heat LCG Timer .................................................................................................... 245
Starting the Heat LCG Timer ............................................................................................. 245
Standing by and starting the Heat LCG Timer ................................................................... 253
Finishing the Heat LCG Timer ........................................................................................... 254
7.4 Mix LCG ................................................................................................................. 255
7.5 Rinse ...................................................................................................................... 258
7.6 Air purge ................................................................................................................ 260
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7.7 Water line disinfection ......................................................................................... 262
Workflow of water line disinfection ..................................................................................... 263
Required items .................................................................................................................. 264
Checking the MRC level and entering the check result ..................................................... 264
Water line disinfection ........................................................................................................ 266
7.8 Self-disinfection and water sampling ................................................................. 274
Workflow of self-disinfection .............................................................................................. 274
Required items .................................................................................................................. 275
Checking the MRC level and entering the check result ..................................................... 275
Performing the self-disinfection ......................................................................................... 277
Microbiological Surveillance .............................................................................................. 281
7.9 Detergent line disinfection .................................................................................. 282
Required items .................................................................................................................. 283
Detergent line disinfection ................................................................................................. 283
7.10 Alcohol line disinfection ...................................................................................... 293
Required items .................................................................................................................. 294
Alcohol line disinfection ..................................................................................................... 294
7.11 Manual leak test .................................................................................................... 303
Workflow of manual leak test ............................................................................................. 304
Performing manual leak test .............................................................................................. 305
7.12 Auto leak test ........................................................................................................ 310
Workflow of auto leak test .................................................................................................. 312
Performing auto leak test ................................................................................................... 313
7.13 Self-check of auto leak test ................................................................................. 321
7.14 Alcohol flush ......................................................................................................... 323
7.15 Leaking scope decontamination ......................................................................... 326
Workflow of leaking scope decontamination ...................................................................... 328
Required items .................................................................................................................. 328
Performing leaking scope decontamination ....................................................................... 329
Chapter 8 Replacement of Consumable Items ................................ 339
8.1 Replacement of consumable items menu .......................................................... 339
8.2 Replacing the disinfectant solution .................................................................... 340
Workflow of replacement the disinfectant solution ............................................................. 341
Draining the disinfectant solution ....................................................................................... 342
Load the disinfectant solution ............................................................................................ 354
Required items .................................................................................................................. 355
Setting the disinfectant solution ......................................................................................... 356
8.3 Replacing the detergent tank .............................................................................. 364
Required item .................................................................................................................... 365
Replacing the detergent tank ............................................................................................. 366
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8.4 Replacing the water filter (MAJ-824 or MAJ-2318) ............................................ 375
Replacing the water filter workflow (when performing the water line disinfection followed by the
replacement of the water filter) .......................................................................................... 377
Required items .................................................................................................................. 377
MRC check, check result input .......................................................................................... 378
Replacing the water filter ................................................................................................... 380
Draining air in the water filter housing ............................................................................... 389
Disinfecting the water line .................................................................................................. 392
8.5 Replacing the air filter (MAJ-823) ........................................................................ 402
Workflow of replacement of the air filter ............................................................................ 402
Required items .................................................................................................................. 402
Replacing the air filter ........................................................................................................ 403
Inspecting air leakage from the air filter connectors .......................................................... 408
8.6 Replacing the gas filter (MAJ-822) ...................................................................... 411
Required items .................................................................................................................. 412
Replacing the gas filter on the lid ...................................................................................... 412
Replacing the gas filter on the disinfectant solution tank ................................................... 416
Chapter 9 Routine Maintenance ........................................................ 423
9.1 Periodic inspection .............................................................................................. 423
9.2 Cleaning the detergent/alcohol drawer .............................................................. 425
9.3 Cleaning the accessories and accessory holder .............................................. 426
Required items .................................................................................................................. 426
Cleaning the accessories and accessory holder ............................................................... 426
9.4 Cleaning the alcohol tank .................................................................................... 428
9.5 Checking cassette cutters ................................................................................... 429
9.6 Cleaning the disinfectant bottle drawer ............................................................. 429
9.7 Cleaning the mesh filter in the water supply hose connector .......................... 430
Required items .................................................................................................................. 430
Cleaning the mesh filter in the water supply hose connector ............................................ 430
9.8 Replacing the fuse ................................................................................................ 434
9.9 Preparing the reprocessor for long-term storage ............................................. 436
Workflow of Preparing the reprocessor for long-term storage ........................................... 437
Required items .................................................................................................................. 437
Preparing the reprocessor for long-term storage ............................................................... 438
9.10 Care and maintenance after long-term storage ................................................. 448
Chapter 10 End-of-Day Checks ........................................................... 451
10.1 Inspection at the end of every working day ....................................................... 451
10.2 Turning the power OFF and closing the water faucet ....................................... 452
10.3 Cleaning the mesh filters ..................................................................................... 453
10.4 Cleaning the float switches ................................................................................. 454
10.5 Cleaning the fluid level sensor ............................................................................ 458
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10.6 Cleaning the stylus pen ....................................................................................... 460
Wiping the stylus pen with alcohol ..................................................................................... 460
Reprocessing together with endoscopes ........................................................................... 460
10.7 Cleaning the outer surface .................................................................................. 461
Chapter 11 Log Management .............................................................. 463
11.1 Log menu .............................................................................................................. 463
11.2 Log display and output ........................................................................................ 464
Information recorded in each record .................................................................................. 470
11.3 Log management with PC ................................................................................... 533
Flow of electronic log management ................................................................................... 534
Required item .................................................................................................................... 534
Output of recorded data to the portable memory ............................................................... 535
Log management on PC .................................................................................................... 541
11.4 Printing records .................................................................................................... 575
Printing .............................................................................................................................. 575
Print format ........................................................................................................................ 579
Chapter 12 Information Menu Screen ................................................. 589
12.1 RFID data check .................................................................................................... 589
12.2 Reprocessor information check ......................................................................... 592
12.3 List management .................................................................................................. 595
Chapter 13 Troubleshooting and Repair ............................................ 599
13.1 Emergency stop and automatic processing after stopping ............................. 599
13.2 Troubleshooting guide ......................................................................................... 600
When the error code [E024] is displayed during the reprocessing process ...................... 614
When any leaks are detected ............................................................................................ 617
When the message screen “Message 087” is displayed ................................................... 627
When the “Message 093” is displayed .............................................................................. 635
Other problems and remedial actions ................................................................................ 642
13.3 OER-Elite return ................................................................................................... 645
Appendix ............................................................................................... 647
System chart .................................................................................................................. 647
Specifications ................................................................................................................ 649
Shipping environment ........................................................................................................ 649
Operating environment ...................................................................................................... 649
Specifications ..................................................................................................................... 650
EMC information ............................................................................................................ 653
License information of Open Source Software ........................................................... 658
License information of Open Source Software ........................................................... 670
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OER-Elite OPERATION MANUAL
Labels and Symbols
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OER-Elite OPERATION MANUAL
The meaning(s) of the symbol(s) shown on the component packaging, the back cover of this instruction
manual and/or this reprocessor are as follows:
For US Customers only
For a Symbols Glossary, visit us:
http://www.olympus-global.com/en/common/pdf/symbolsglossary.pdf
Safety-related labels and symbols are attached to the reprocessor at the locations shown next page. If
labels or symbols are missing or illegible, contact Olympus.
Labels and Symbols
Symbol Description
Refer to instructions.
Endoscope reprocessor
Manufacturer
Authorized representative in the European Community
Lot number
Serial number
Non-ionizing electromagnetic radiation
Date of manufacture
Fuse
General prohibition sign
2
Labels and Symbols
OER-Elite OPERATION MANUAL
Front panel
RFID marking
UDI label
A label required by some countries’
regulations regarding identification of
medical device also known as Unique
Device Identification (UDI).
Labels and Symbols
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OER-Elite OPERATION MANUAL
Inner side
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
FRA
Date of manufacture
4
Labels and Symbols
OER-Elite OPERATION MANUAL
Rear panel
CSA/UL MARKING
Labels and Symbols
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OER-Elite OPERATION MANUAL
Top panel
Rotation direction
indicator label
Indicates the rotation
directions for locking
and releasing gas filter
case (lid).
FRA
FRA
FRA
6
Labels and Symbols
OER-Elite OPERATION MANUAL
Reprocessing basin
Fonts displayed on the touch screen
Ricoh bitmap fonts designed by RICOH Company, Ltd. are used.
Important Information — Please Read Before Use
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OER-Elite OPERATION MANUAL
Intended use
The OER-Elite is intended for use in cleaning and high-level disinfection of heat sensitive Olympus
flexible endoscopes, their accessories, and endoscope reprocessor accessories. Safe use requires
detergent and an FDA-cleared high-level disinfectant/sterilant that Olympus has validated to be
efficacious and compatible with the materials of the OER-Elite and Olympus flexible endoscopes, their
accessories, and endoscope reprocessor accessories. Use of a detergent or high-level
disinfectant/sterilant that has not been validated by Olympus may be ineffective and can damage the
OER-Elite components and the endoscopes being reprocessed. Endoscopes must be cleaned by the
user prior to reprocessing; however, use of the OER-Elite enables the user to perform modified manual
cleaning of some endoscopes prior to automated cleaning and high-level disinfection in the OER-Elite.
Instruction manuals
The instructions for this reprocessor are divided into two volumes: “Instructions-Installation Manual”,
and “Instructions-Operation Manual”.
Instructions regarding the preparation of endoscopes prior to placing them in the OER-Elite are found
in “Instructions-Operation Manual”.
Each of these manuals contains essential information for using this reprocessor safely and effectively.
The “Instructions-Installation Manual” describes how to install the reprocessor. The
“Instructions-Operation Manual” describes how to operate and maintain the reprocessor and describes
modifications to the manual endoscope cleaning process that can save the user time and
inconvenience, if the endoscope is going to be subsequently reprocessed using the OER-Elite.
The “List of Compatible Endoscopes/Connecting Tubes <OER-Elite>” identifies all Olympus model
endoscopes that are compatible with the OER-Elite, plus the specific connecting tube(s) required for
each of these endoscope models.
The descriptions in these manuals assume that all endoscopes are reprocessed in the OER-Elite using
both an Olympus-validated detergent and disinfectant. Contact Olympus to obtain the list of both
Olympus-validated disinfectant solutions and detergents.
Before using this reprocessor, be sure to review all of the above-mentioned manuals, the safety
information provided with Olympus-validated detergents and disinfectants, and the manuals for all
other equipment used in the process. Always use this reprocessor as instructed. It might cause
unexpected danger if you do not follow the installation and operation manual. Keep these and all
related instruction manuals and documents in a safe and accessible location.
If you have any questions or comments about any information in these manuals, contact Olympus.
Important Information — Please Read Before Use
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Important Information — Please Read Before Use
OER-Elite OPERATION MANUAL
Terms used in these manuals
ALT
Stands for Auto Leak Test.
Air purge
In this operation, air is fed into an endoscope channel to blow out residual fluid. This
operation is usually performed automatically during a process, but it can also be activated
independently. Air purge is also used to drain cleaning fluid or disinfectant solution from
inside the reprocessor when the operation has stopped due to an error code, etc.
Alcohol
70% ethyl alcohol or 70% isopropyl alcohol.
Alcohol flush
To assist in drying the channels after reprocessing, alcohol is flushed through the
endoscope channels followed by air. This operation can be performed as the last step of
the reprocessing program or as an independent operation.
Automatic processing
When the reprocessor is stopped by the operator or due to an error, it identifies its status
and executes the optimum operation automatically. For example, if the reprocessor stops
in the middle of the disinfection process, it terminates the disinfection process and
removes the disinfectant solution.
Channel blockage monitoring
This function monitors the channel blockage of endoscope’s suction channel due to a
foreign object, etc., during a reprocessing program.
Channel connectivity monitoring
This function monitors the connection status of the connecting tubes during a
reprocessing program.
Channel monitoring
“Channel monitoring” will be used as a generic term meaning “Channel connectivity
monitoring” and “Channel blockage monitoring”.
Cleaning fluid
Refers to filtered water with detergent that is used during the cleaning process.
Cleaning process
A series of operations programmed into the reprocessor that enable it to perform
ultrasonic cleaning and detergent cleaning of endoscopes.
Important Information — Please Read Before Use
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OER-Elite OPERATION MANUAL
Detergent
Olympus-validated detergent. Refer to Section 2.8, “Consumable accessories (Optional)”
for details.
Disinfectant solution
Olympus-validated disinfectant solution. Refer to Section 2.8, “Consumable accessories
(Optional)” for details.
Disinfection process
A series of operations programmed into the reprocessor that enable it to perform
disinfection of endoscopes.
Error code
A code consisting of [E] and a three-digit number. This code is displayed on the touch
screen if there is a problem with the reprocessor. When an error code is displayed, check
the troubleshooting guide.
LCG
Liquid Chemical Germicide. It refers to disinfectant solution displayed on GUI.
Leak test
A test to confirm that an endoscope is free of leaks. This reprocessor is capable of both
the auto leak test and the manual leak test.
Manual cleaning
Cleaning of an endoscope by hand.
Modified precleaning and manual cleaning
A precleaning and manual cleaning method that is simplified due to subsequent use of the
OER-Elite which automates cleaning steps in the process.
MRC
Minimum Recommended Concentration.
Patient ID
Identity information specific to each patient. It can be recorded in the histories of
reprocessing, etc. For the patient ID input method, refer to Section 3.6, “Entering ID”.
Physician ID
Identity information specific to each endoscopist. It can be recorded in the histories of
reprocessing, etc. For the physician ID input method, refer to Section 3.6, “Entering ID”.
Portable memory
A digital medium for storage.
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Important Information — Please Read Before Use
OER-Elite OPERATION MANUAL
Precleaning
Cleaning of an endoscope performed after each procedure at the bedside in the
endoscopy room.
Procedure ID
Identity information specific to each procedure of the patient. It can be recorded in the
histories of reprocessing, etc. For the procedure ID input method, refer to Section 3.6,
“Entering ID”.
Process
Generic term for any operation, including cleaning and disinfection that is performed
automatically by this reprocessor.
Reprocessing process
A series of operations for ultrasonic cleaning, detergent cleaning, disinfection, rinse, air
purge, and alcohol flush of the outer surface or channels of endoscopes that run in a
specified sequence and for a specified time. Reprocessing programs [1] to [4] can be
selected by the user. Programs [1] to [4] have a fixed cleaning process time and
disinfection process time. They also have different patterns of auto leak test and channel
monitoring respectively.
Scope ID
Identity information specific to each endoscope. It can be recorded in the historical data of
reprocessing, etc. For the scope ID input method, refer to Section 3.6, “Entering ID”.
Shelf life
The date of expiration of the effectiveness of a detergent or disinfectant before it is
opened.
Test strip
Device used to test if the concentration of disinfectant solution is effective for disinfection.
Refer to Section 2.8, “Consumable accessories (Optional)” for details. (i.e., the minimum
recommended concentration (MRC) specified by the disinfectant manufacturer)
User ID
Identity information specific to each reprocessing operator. It can be recorded in the
histories of reprocessing, etc. For the user ID input method, refer to Section 3.6, “Entering
ID”.
Important Information — Please Read Before Use
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OER-Elite OPERATION MANUAL
User qualifications
The operator of this reprocessor must be sufficiently trained in reprocessing of endoscopes. The
medical literature reports cases of infections due to inappropriate cleaning, disinfection, and /or
sterilization. Thoroughly review and understand the following items before use:
Cleaning, disinfection, and sterilization procedures described in the instruction manuals for
the endoscope and ancillary equipment.
Professional health and safety standards.
Applicable guidelines on cleaning, disinfection, and sterilization of endoscopy equipment.
Structure and handling of endoscopic equipment.
Personal protective equipment requirements to minimize exposure to chemicals and
infectious materials.
These manuals do not explain or discuss detailed cleaning, disinfection, and sterilization procedures.
For more details, consult your facility’s procedures, professional guidelines, and regulatory
requirements for reprocessing endoscopes.
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Important Information — Please Read Before Use
OER-Elite OPERATION MANUAL
Ensuring the safety of reprocessing personnel
• Disinfectant solution and detergent may irritate the mucous membranes in the eyes and
respiratory organs. If disinfectant solution contacts the skin directly and eyes, it may cause
irritation or damage. Therefore, before handling high-level disinfectant solution and detergent,
carefully read the instructions for use and the safety data sheet. For further details, contact
Olympus.
• While using chemicals, wear appropriate personal protective gear to prevent contact with or
inhalation of chemicals or infectious substances. Personal protective gear includes eyewear,
face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are
long enough so that your skin and eyes is not exposed. All personal protective gear should be
inspected before use and replaced periodically before it is damaged.
• When using disinfectant solution and alcohol, Olympus recommends the use of gas filters and
running this reprocessor in well-ventilated areas.
Wear a face mask, gloves, and protective clothes to minimize aspiration and skin contact.
Wear goggles for eye protection.
Refer to the following association’s guidelines related to ventilation:
If the person operating the reprocessor exhibits an allergic reaction or symptoms, no matter
how slight, they should discontinue the task they are performing and vacate the room.
• Before handling the detergent or disinfectant, read the SDS (material safety data sheets) and
learn what measures to take in the event of exposure.
• Operators who exhibit symptoms of an allergic reaction or sensitivity to the reprocessing
chemicals should not operate this reprocessor.
• This reprocessor can be set up to use the RFID (Radio Frequency Identification) function. Be
aware that the radio waves emitted from the RFID reader of the reprocessor may cause
medical devices such as pacemakers to malfunction. If any interference with the equipment is
found, immediately move away from the RFID reader or set the power switch to OFF. Contact
a medical professional immediately if symptoms persist.
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)
Important Information — Please Read Before Use
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OER-Elite OPERATION MANUAL
Equipment compatibility
Use the OER-Elite in combination with ancillary equipment listed in “System chart” on page 647. Using
incompatible equipment may result in patient or operator injury and equipment damage and/or
malfunction.
Olympus has not tested the efficacy of reprocessing on the OER-Elite in combination with endoscopes
that are not listed on the “List of compatible Endoscopes/Connecting Tubes <OER-Elite>”.
If using endoscopes that are not listed on the “List of compatible Endoscopes/Connecting Tubes
<OER-Elite>”, reprocessing of endoscopes may be insufficient.
Care and storage
After use, reprocess and store this reprocessor referring to the instructions in Chapter 10, “End-of-Day
Checks” in this manual. Inappropriate care and storage could present an infection control risk and/or
cause reprocessor damage or malfunction.
Maintenance and Inspection
• The OER-Elite requires routine maintenance and inspection. In addition to checks before use,
the person in charge of maintenance and administration of the medical equipment at the
facility should periodically check all of the items described in this manual. If any irregularity is
found, do not use the reprocessor and inspect it as described in Section 13.2,
“Troubleshooting guide”. If the irregularity is still present, the reprocessor must be repaired
prior to next use.
• If the PERIODIC MAINTENANCE indicator starts to indicate on the touch screen, described
in Section 2.7, “Control panels”, the time for regularly scheduled maintenance is near. Contact
Olympus to perform the maintenance.
Repair and modification
Do not disassemble, modify, or attempt to repair this reprocessor and its accessories. Doing so could
result in operator or patient injury and/or equipment damage or malfunction. Some problems that
appear to be malfunctions may be corrected by referring to Chapter 13, “Troubleshooting and Repair”.
If the problem cannot be resolved using the information in Chapter 13, “Troubleshooting and Repair”,
contact Olympus.
14
Important Information — Please Read Before Use
OER-Elite OPERATION MANUAL
Disposal of disinfectant solution
Expired disinfectant solution for this reprocessor should be handled as directed in the
Olympus-validated disinfectant product label and instructions. Follow all applicable national, state, and
local guidelines.
Disposal of this reprocessor
When disposing of this reprocessor and accessories, follow all applicable national, state, and local
regulations and guidelines.
Signal words
The following signal words are used throughout these manuals:
Warnings and cautions
Follow the warnings and cautions given below when handling this reprocessor. This information is
supplemented by warnings given in each chapter.
WARNING
• Do not insert an EndoTherapy accessory or other object through an opening
including the air vent of the reprocessor.
• Do not allow any liquid (including water or disinfectant solution) to flow into an
opening. Contact with an electrical part inside the reprocessor could cause an
electric shock or reprocessor failure.
• Always remove the tank from the detergent/alcohol drawer before putting detergent
or alcohol in the tank. If detergent or alcohol is spilled on the detergent/alcohol
drawer, it could get inside the reprocessor and contact an electrical part inside,
causing an electric shock or fire hazard.
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.
WARNING
CAUTION
NOTE
Important Information — Please Read Before Use
15
OER-Elite OPERATION MANUAL
WARNING
• Do not install this reprocessor in any place where any of the following are present.
High oxygen concentration
Oxidizing substance such as Nitrous Oxide (N
2
O)
Flammable anesthetic gas
This reprocessor is not explosion-proof and may explode or cause a fire under
these conditions.
• Always use the power cord provided with this reprocessor. Otherwise, reprocessor
failure or power cord burnout may result. Also, remember that the provided power
cord is for use only with this reprocessor and should not be used with any other
equipment.
CAUTION
• Do not press any of the switches on the control panel of this reprocessor with a
pointed or hard object. Otherwise, the switch may be damaged.
• Be sure to turn off the water faucet and the power switch of the reprocessor at the
end of the day to avoid potential water leaks.
• To avoid malfunctions, do not use this reprocessor in a dusty environment.
• To avoid electromagnetic interference from other equipment, do not install any
other electrical devices in close proximity to this reprocessor (aside from ancillary
devices used with this reprocessor).
• This equipment enables radio communication by RFID and emits RF (radio
frequency: 13.56 MHz) energy to perform the said intended functions. It may cause
electromagnetic interference in nearby electronic equipment, and is labeled with
the symbol below. If electromagnetic interference occurs, mitigation measures may
be necessary, such as moving the electronic equipment away, reorienting or
relocating this instrument, or shielding the location. An electromagnetic
interference with other devices may shorten the communications distance of the
designated ID tag and cause signals to become unreadable. Try to take mitigation
measures such as keeping the affecting device away from this equipment.
16
Outline of Functions
OER-Elite OPERATION MANUAL
Following functions are available in this reprocessor.
Reprocessing
A series of operations that enable the reprocessor to perform ultrasonic cleaning, detergent
cleaning, disinfection, rinse, air purge, and alcohol flush. A series of operations for ultrasonic
cleaning, detergent cleaning, disinfection, rinse, air purge, and alcohol flush of the outer surface
and channels of endoscopes in a specified sequence and for a specified time. Reprocessing
programs [1] to [4] can be selected by the user. Programs [1] to [4] have a fixed cleaning
process time and disinfection process time. They also have different patterns of auto leak test
and channel monitoring respectively. For details, refer to Chapter 6, “Reprocessing Operations”.
Heat LCG
A process for heating disinfectant solution until it reaches the specified temperature (22q, 72qF).
This process is performed automatically during the reprocessing program. It can also be
performed as an independent operation. For details, refer to Section 7.2, “Heat LCG”.
Heat LCG Timer
The function for heating the disinfectant solution until the specified temperature (22q, 72qF) by
the specified time. For details, refer to Section 7.3, “Heat LCG Timer”.
Drain LCG
This function drains the disinfectant solution from the disinfectant tank. For details, refer to
Section 8.2, “Replacing the disinfectant solution”.
Load LCG
This function loads the disinfectant solution after inserting a new disinfectant bottle. For details,
refer to Section 8.2, “Replacing the disinfectant solution”.
Mix LCG
This function mixs the disinfectant solution to the appropriate concentration and enables
accurate concentration check.
Outline of Functions
Outline of Functions
17
OER-Elite OPERATION MANUAL
Water line disinfection
This function disinfects the water supply line and other lines inside the reprocessor. For details,
refer to Section 7.7, “Water line disinfection”.
Self disinfection and water sampling
This function disinfects the basin and internal piping of the reprocessor. End of the process,
sampling of rinse water can be performed for microbiological surveillance. For details, refer to
Section 7.8, “Self-disinfection and water sampling”.
Detergent/Alcohol line disinfection
This function disinfects the detergent line and alcohol line of the reprocessor. For details, refer to
Section 7.9, “Detergent line disinfection” and Section 7.10, “Alcohol line disinfection”.
Auto leak test
The endoscope leak test can be executed automatically by programming it in a user-configured
reprocessing process. It can also be performed as an independent operation. For details, refer
to Section 7.12, “Auto leak test”.
Manual leak test
Manual inspection for endoscope leakage during immersion of water can be performed as an
independent operation. For details, refer to Section 7.11, “Manual leak test”.
Alcohol flush
To assist in drying the channel after reprocessing, alcohol is flushed through the endoscope
channels followed by air. This function performs alcohol flush into the endoscope channels. The
alcohol flush can be executed automatically in a reprocessing process. It can also be performed
as an independent operation. For details, refer to Section 7.14, “Alcohol flush”.
Air purge
This function drains the remaining fluid from the basin after an irregularity occurs, or if the
process is stopped before it completes. Air purge also eliminates residual fluid from the
endoscope channels. For details, refer to Section 7.6, “Air purge”.
18
Outline of Functions
OER-Elite OPERATION MANUAL
Rinse
This function performs the rinsing process if the fluid remains in the basin or in the endoscopes
after an irregularity occurs or the process is stopped midway. For details, refer to Section 7.5,
“Rinse”.
Leaking scope decontamination
This function decontaminates a leaking endoscope prior to repair. During the decontamination,
positive pressure is applied to the leaking endoscope to avoid fluid invasion and damage to the
endoscope. For details, refer to Section 7.15, “Leaking scope decontamination”.
ALT self-check
This function checks the auto leak test function of the reprocessor. It is performed automatically
at the end of Load LCG function or as an independent operation. For details, refer to
Section 7.13, “Self-check of auto leak test”.
1.1 Checking the package contents
19
OER-Elite OPERATION MANUAL
Ch.1
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.
1.1 Checking the package contents
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)
20
1.1 Checking the package contents
OER-Elite OPERATION MANUAL
Ch.1
Accessories for use in reprocessing
Connecting tube (MAJ-2110, 2 pcs) Connecting tube (MAJ-2111, 2 pcs) Connecting tube (MAJ-2112, 2 pcs)
Connecting tube (MAJ-2113, 2 pcs) Leak test air tube
(MAJ-2127, 2 pcs)
Accessories to be attached to the reprocessor
Gas filter case (GJ460700) Gas filter (2 pcs) (MAJ-822) Gas filter adapter (splash guard)
(GC949900)
Washing case (MAJ-2121) Air filter (MAJ-823) Water filter (MAJ-824 or MAJ-2318)
Stylus pen holder (RA016500) Hex wrench (GT804300) M4 × 10 mm cap bolt (2 pcs)
Stylus pen (GT944200)
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