OER-Pro (For Aldahol III) ENDOSCOPE REPROCESSOR Operation Manual

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

Inspection Before Use...

32

Inspecting for water leakage from the water supply piping and within the equipment ...

34

Chapter 3 3.1 3.2

Inspecting the equipment’s connectors...

35

3.3

Inspecting the connecting tubes and leak test air tube ...

36

3.4

Inspecting the remaining quantity of detergent, and replenishment

37

3.5

Inspecting the remaining quantity of alcohol, and replenishment ...

43

3.6

Inspecting the mesh filters ...

48

3.7

Inspecting for disinfectant solution odor...

49

3.8

Inspecting the disinfectant solution’s concentration level ...

50

3.9

Inspecting the printer paper roll ...

53

ENDOSCOPE REPROCESSOR OER-Pro Operation Manual

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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 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

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End-of-Day Checks... 109

Other Functions ... 119

6.1

Confirming the disinfectant solution temperature...

119

6.2

Heating the disinfectant solution ...

120

6.3

Setting the reprocessing programs ...

122

6.4

Setting the disinfectant solution counter ...

126

6.5

Display of the total number of times the disinfectant solution was supplied...

131

6.6

Display the total operation count of the equipment ...

131

6.7

Air purge ...

132

6.8

Rinsing ...

133

6.9

Emergency stop and automatic processing after stopping ...

134

ENDOSCOPE REPROCESSOR OER-Pro Operation Manual

Contents

Chapter 7

Routine Maintenance ... 136

7.1

Replacing the gas filter (MAJ-822)...

138

7.2

Replacing the water filter (MAJ-824)...

142

7.3

Disinfecting the water supply piping...

152

7.4

Microbiological surveillance ...

160

7.5

Replacing the air filter (MAJ-823) ...

165

7.6

Cleaning the float switch ...

168

7.7

Checking the lid and lid packing ...

170

7.8

Cleaning the detergent/alcohol drawer ...

171

7.9

Cleaning the detergent tank...

172

7.10 Cleaning the accessories and accessory holders...

173

7.11 Cleaning the alcohol tank...

175

7.12 Replacing the disinfectant solution ...

176

7.13 Cleaning the mesh filter in the water supply adapter connector ...

193

7.14 Replacing the fuse ...

195

7.15 Disinfecting the detergent/alcohol pipe ...

196

7.16 Preparing the reprocessor for long-term storage ...

204

7.17 Installing the printer paper roll...

211

7.18 Care and maintenance after long-term storage ...

217

Chapter 8

Troubleshooting and Repair... 218

8.1

Troubleshooting guide ...

218

8.2

Returning the endoscope reprocessor for repair ...

227

Appendix ... 228 System chart ...

228

Shipping environment ...

230

Operating environment...

230

Specifications ...

230

EMC information ...

233

ENDOSCOPE REPROCESSOR OER-Pro Operation Manual

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Contents

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ENDOSCOPE REPROCESSOR OER-Pro Operation Manual

Labels and Symbols

Labels and Symbols The meaning(s) of the symbol(s) shown on the package with the components, the back cover of this instruction manual and/or this equipment are as follows:

Refer to instructions.

Caution, hot surface

Endoscope reprocessor

Manufacturer

Authorized representative in the European Community

ENDOSCOPE REPROCESSOR OER-Pro Operation Manual

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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

RFID marking

2

ENDOSCOPE REPROCESSOR OER-Pro Operation Manual

Labels and Symbols

 Top panel

Rotation direction indicator label Indicates the rotation directions for locking and releasing each gas filter case.

ENDOSCOPE REPROCESSOR OER-Pro Operation Manual

3

Labels and Symbols

 Inner side

4

ENDOSCOPE REPROCESSOR OER-Pro Operation Manual

Labels and Symbols

Rotation direction indicator label Indicates the rotation direction for locking and releasing each gas filter case.

Error code table Lists error codes, possible causes, and remedial actions for details, see Section 8.1, “Troubleshooting guide” on page 218 in the “Instructions-Operation Manual”.

Rating plate Shows the product model, power rating, and serial number.

ENDOSCOPE REPROCESSOR OER-Pro Operation Manual

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Labels and Symbols

 Rear panel

CSA/UL MARKING

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

8

•

Before handling the high-level disinfectant solution (Aldahol III), carefully read the instructions for use and the material safety data sheet.

•

During reprocessing, wear appropriate personal protective equipment to prevent contact with or inhalation of infectious substances or disinfectant. Personal protective equipment includes eye wear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed. All personal protective equipment should be inspected before use and replaced periodically before it is damaged.

ENDOSCOPE REPROCESSOR OER-Pro Operation Manual

Important Information - Please Read Before Use

•

When using the disinfectant solution and alcohol, Olympus recommends the use of gas filters and running this equipment in well-ventilated areas.  Wear a facemask, gloves, and protective clothes to minimize aspiration and skin contact.  Wear goggles for eye protection. Refer to the following association's guidelines related to ventilation: SGNA

(Society of Gastroenterology Nurses and Associates)

ASGE

(American Society of Gastroenterological Endoscopy)

APIC

(Association for Professionals of Infection Control and Epidemiology)

AORN

(Association of Preoperative Registered Nurses)

ASTM

(American Society for Testing and Materials)

OSHA

(Occupational Safety and Health Administration)

ACGIH

(American Conference of Governmental Industrial Hygienists)

NIOSH

(National Institute for Occupational Safety and Health)

AIA

(American Institute of Architects)

Do not handle the equipment if the operator shows any allergic symptoms even while wearing protective gear. •

Before handling the detergent or disinfectant, read the material safety data sheets and learn what measures to take in the event of exposure.

•

Operators who exhibit symptoms of an allergic reaction or sensitivity to the reprocessing chemicals should not operate this equipment.

•

This equipment can be set up to use the RFID function. Please be aware that the radio waves emitted from the equipment may cause medical devices such as pacemakers to malfunction.

ENDOSCOPE REPROCESSOR OER-Pro Operation Manual

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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

Important Information - Please Read Before Use

Disposal of waste fluids The waste fluids of this equipment should be treated as directed in the Aldahol III instruction manuals and follow all applicable national and local guidelines.

Disposal of this equipment When disposing of this equipment and accessories, follow all applicable national, state, and local regulations and guidelines.

Signal words The following signal words are used throughout these manuals:

Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage.

Indicates additional helpful information.

ENDOSCOPE REPROCESSOR OER-Pro Operation Manual

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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 fire under these conditions.

Always use the power cord provided with this equipment. Otherwise, equipment failure or power cord burnout may result. Also, remember that the provided power cord is for use only with this equipment and should not be used with any other equipment.

12

•

Do not press any of the switches on the main or subcontrol panel of this equipment with a pointed or hard object. Otherwise, the switch may be damaged.

•

Be sure to turn off the faucet and the power switch of the equipment at the end of the day. Otherwise, water supply hose might slip off the connection when not in use (e.g., nighttime or holidays) because of the unexpected change in water pressure.

ENDOSCOPE REPROCESSOR OER-Pro Operation Manual

Important Information - Please Read Before Use

•

To avoid malfunctions, do not use this equipment in a dusty environment.

•

To avoid electromagnetic interference from other equipment, do not install any other electrical devices in close proximity to this equipment (aside from ancillary devices used with this equipment).

•

This equipment provides a radio communication function by RFID and emits RF (Radio Frequency) energy to perform the said intended functions. Therefore, it may cause electromagnetic interference in nearby electronic equipment, and is labeled with the following symbol. If electromagnetic interference occurs, mitigation measures may be necessary, such as moving the electronic equipment away, reorienting or relocating this instrument, or shielding the location. An electromagnetic interference with other devices may shorten the communications distance of the designated ID tag and cause signals to become unreadable. Try to take mitigation measures such as keeping the affecting device away from this equipment.

ENDOSCOPE REPROCESSOR OER-Pro Operation Manual

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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 alkaline detergent (EndoRapid). Disinfectant solution Olympus-designated disinfectant solution (Aldahol III). Alcohol 70% ethyl alcohol or isopropyl alcohol. Process Generic term for any operation, including cleaning and disinfection, that is performed automatically by this equipment. Cleaning process A series of operations programmed into the equipment that enable it to perform ultrasonic cleaning and detergent cleaning of an endoscope. Disinfection process A series of operations programmed into the equipment that enable it to perform disinfection of an endoscope. Leak test A test to confirm that an endoscope is waterproof. Air purge In this operation, air is fed into an endoscope channel to blow out any internal moisture. This operation is usually performed automatically during a process, but it can also be activated independently. Air purge is also used to drain cleaning fluid or disinfectant solution from inside the equipment when the operation has stopped due to an error code, etc.

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ENDOSCOPE REPROCESSOR OER-Pro Operation Manual

Important Information - Please Read Before Use

Reprocessing programs A series of operations for ultrasonic cleaning, detergent cleaning, disinfection, and rinsing of the outer surface and channels of endoscopes that run in a specified sequence and for a specified time. Reprocessing programs [1] to [3] can be selected by the user. Program [1] consists of a preset series of processes confirmed as effective at our factory. Programs [2] and [3] can be set up by the user. Alcohol flushing To dry the channel after reprocessing, alcohol is passed through the endoscope channel and then air is fed through. This operation can be performed as the last step after completion of the reprocessing program or as an independent operation. Disinfectant solution heating A process for heating disinfectant solution until it reaches the appropriate temperature. When this process is included in a reprocessing program, it is performed automatically during the program. It can also be performed as an independent operation. Test strip Device used to test if the concentration of disinfectant solution is effective for disinfection. Meets the minimum recommended concentration (MRC) specified by the disinfectant manufacturer. Error code A code consisting of [E] and a two-digit number. This code is displayed on the main control panel if there is a problem with the equipment. When an error code is displayed, check the error code list to find out what corrective measures to take. Automatic Processing When the equipment is stopped by the operator or due to an error, it identifies its status and executes the optimum operation automatically. For example, if the device stops in the middle of disinfection process, it terminates the disinfection process and removes the disinfectant solution.

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