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OER-Pro
Operation Manual
57 pgs2.86 Mb0

Olympus OER-Pro Operation Manual

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 ..................................................................... 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 ............................................................................ 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
Chapter 3 Inspection Before Use............................................. 32
3.1 Inspecting for water leakage from the water supply piping
and within the equipment ................................................................ 34
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
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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 End-of-Day Checks .................................................. 109
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 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
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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
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Contents
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ENDOSCOPE REPROCESSOR OER-Pro Operation Manual
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
Labels and Symbols
Manufacturer
Authorized representative in the European Community
1
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
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ENDOSCOPE REPROCESSOR OER-Pro Operation Manual
Labels and Symbols
Rotation direction indicator label
Indicates the rotation directions for locking and releasing each gas filter case.
Top panel
3
Labels and Symbols
Inner side
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ENDOSCOPE REPROCESSOR OER-Pro Operation Manual
Rotation direction indicator label
Indicates the rotation direction for locking and releasing each gas filter case.
Labels and Symbols
Rating plate
Shows the product model, power rating, and serial number.
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”.
5
Labels and Symbols
CSA/UL MARKING
Rear panel
Option terminal
Used for connecting ancillary equipment (for service engineer use only).
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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.
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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, 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.
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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.
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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.
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.
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ENDOSCOPE REPROCESSOR OER-Pro Operation Manual
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:
Important Information — Please Read Before Use
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 (N
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.
• 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.
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ENDOSCOPE REPROCESSOR OER-Pro Operation Manual
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