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INSTRUCTIONS SUCTION VALVE
MAJ-1443 AIR/WATER VALVE
MAJ-1444
USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Contents
Contents Symbols...
1
Important Information - Please Read Before Use 2 Intended use ... 2 Instruction manual ... 3 User qualifications ... 3 Instrument compatibility ... 3 Reprocessing before the first use and/or reprocessing and storage after use ... 4 Repair and modification ... 4 Signal words ... 5 Warnings and cautions ... 5
Chapter 1
Checking the Package Contents...
6
Chapter 2
Instrument Nomenclature...
8
Chapter 3
Preparation and Inspection ...
9
Preparation and inspection ... Inspection of the valve ... Attaching the valve ... Inspection of the functionality ...
10 10 12 14
3.1 3.2 3.3 3.4
Chapter 4 4.1 4.2
Suction and aspiration form the balloon (Suction valve) ... 19 Air feeding, water feeding the lens and water feeding into the balloon (Air/water valve) ... 21
Chapter 5 5.1 5.2 5.3 5.4 5.5 5.6 5.7
Operation ... 18
Reprocessing: General Policy ... 23
Instructions ... 23 Notes for cleaning, disinfection and sterilization personnel ... 24 Precautions... 25 Compatibility summary ... 27 Detergent solution... 28 Disinfectant solution... 28 Rinse water... 29
SUCTION VALVE MAJ-1443 AIR/WATER VALVE MAJ-1444
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Contents
5.8 5.9
Alcohol ... Steam sterilization (autoclaving)...
Chapter 6 6.1 6.2 6.3 6.4 6.5
29 30
Cleaning, Disinfection and Sterilization Procedures ... 31
Preparation of the equipment ... Cleaning... High-level disinfection... Rinsing after high-level disinfection ... Sterilization ...
31 32 35 36 38
Chapter 7
Cleaning and Disinfection Equipment ... 40
Chapter 8
Storage ... 42
Chapter 9
Troubleshooting ... 43
9.1
Troubleshooting Guide ...
43
Appendix... 47 System Chart ... Appendix... Operating Environment...
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Symbols
Symbols The meaning(s) of the symbol(s) shown on the back cover of this instruction manual or the component packaging are as follows:
Manufacturer
Authorized representative in the European Community Lot number For US Customers only For a Symbols Glossary, visit us: http://www.olympus-global.com/en/common/pdf/symbolsglossary.pdf
SUCTION VALVE MAJ-1443 AIR/WATER VALVE MAJ-1444
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Important Information - Please Read Before Use
Important Information - Please Read Before Use Intended use This valve has been designed for use with an Olympus ultrasonic endoscope for the gastrointestinal (GI) tract, as follows.
Suction valve (MAJ-1443) •
To remove any fluid or debris adhering to the objective lens.
•
To remove the water from the balloon.
Air/water valve (MAJ-1444)
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•
To feed air to remove any fluid or debris adhering to the objective lens.
•
To feed water for lens washing.
•
To fill the balloon with sterile water.
SUCTION VALVE MAJ-1443 AIR/WATER VALVE MAJ-1444
Important Information - Please Read Before Use
Instruction manual This instruction manual contains essential information on using this valve safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment which will be used during the procedure and use the instruments as instructed. Keep this and all related instruction manuals in a safe, accessible location. If you have any questions or comments about any information in this manual, please contact Olympus.
User qualifications The operators of this valve must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique. This manual, therefore, does not explain or discuss clinical endoscopic procedures. For details on clinical endoscopic procedures, it is recommended that the physician and operator make judgments from their viewpoints as specialists.
Instrument compatibility This valve is compatible with the following instruments: OLYMPUS Ultrasonic endoscope for the gastrointestinal (GI) tract. Do not use this valve in other combinations. Using incompatible equipment can result in patient injury and/or equipment damage.
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Important Information - Please Read Before Use
Reprocessing before the first use and/or reprocessing and storage after use This valve was not cleaned, disinfected or sterilized before shipment. Before using a valve for the first time, reprocess it according to the instructions in Chapter 5, “Reprocessing: General Policy”. After using a valve, reprocess and store it according to the instructions given in Chapter 5, “Reprocessing: General Policy” through Chapter 8, “Storage”. Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance.
Repair and modification This valve does not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair; this may result in patient or user injury and/or equipment damage. Problems that appear to be malfunctions may be correctable by referring to Chapter 9, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 9, contact Olympus.
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SUCTION VALVE MAJ-1443 AIR/WATER VALVE MAJ-1444
Important Information - Please Read Before Use
Signal words The following signal words are used throughout this manual: 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.
Warnings and cautions After using this valve, reprocess and store it according to the instructions given in Chapter 5, “Reprocessing: General Policy”, through Chapter 8, “Storage”. Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection.
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Chapter 1 Checking the Package Contents
Chapter 1
Checking the Package Contents
Match all items in the package with the components shown below. Inspect each item for damage. If a valve is damaged, a component is missing or you have any questions, do not use the valve; immediately contact Olympus. This valve was not disinfected or sterilized before shipment. Before using this valve for the first time, reprocess it according to the instructions in Chapter 5, “Reprocessing: General Policy”.
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SUCTION VALVE MAJ-1443 AIR/WATER VALVE MAJ-1444
Chapter 1 Checking the Package Contents
Suction valve (MAJ-1443)
Suction valve (MAJ-1443)
Instruction manual
Air/water valve (MAJ-1444)
Air/water valve (MAJ-1444)
Instruction manual
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Chapter 2 Instrument Nomenclature
Chapter 2
Instrument Nomenclature
Nomenclature Suction valve (MAJ-1443) Cap Spring Skirt
Packing Hole
Air/water valve (MAJ-1444) Cap
Hole
Spring Skirt Top view Packings
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SUCTION VALVE MAJ-1443 AIR/WATER VALVE MAJ-1444
Seal
Chapter 3 Preparation and Inspection
Chapter 3
Preparation and Inspection
Before each case, prepare and inspect this valve as instructed below. Inspect other equipment to be used with this valve as instructed in their respective instruction manuals. Should the slightest irregularity be suspected do not use the valve and see Chapter 9, “Troubleshooting”. If the irregularity is still suspected after consulting Chapter 9, do not use the valve and use a new one. •
Using a valve that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.
•
The valve was not cleaned, disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions in Chapter 5, “Reprocessing: General Policy”. Otherwise, an infection control risk and/or tissue irritation may result.
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Chapter 3 Preparation and Inspection
3.1
Preparation and inspection Prepare the valve and the equipment (for compatibility, see the “System Chart” in the Appendix) and personal protective equipment, such as eye wear, face mask, moisture-resistant clothing and chemical-resistant gloves, before each use. Refer to the respective instruction manuals for each piece of equipment. The valves are consumables. If the inspection of the valve reveals any irregularities, use new valves.
3.2
Inspection of the valve 1. While referring to Chapter 2, “Instrument Nomenclature”, visually inspect the valve and all of its components visually as follows:
10
•
Confirm the hole is not blocked.
•
Confirm that the valve is not deformed or cracked.
•
Check for excessive scratching or tears in the seal and packings.
•
Confirm that the seal or packing is not peeled off.
SUCTION VALVE MAJ-1443 AIR/WATER VALVE MAJ-1444
Chapter 3 Preparation and Inspection
Suction valve (MAJ-1443) Holding the suction valve’s skirt push the valve down all the way and confirm that it moves smoothly (see Figure 3.1).
Figure 3.1
Air/water valve (MAJ-1444) Holding the air/water valve’s skirt push the valve down all the way and confirm that it moves smoothly (see Figure 3.2).
Figure 3.2
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Chapter 3 Preparation and Inspection
3.3
Attaching the valve •
Do not apply lubricant to the valve, as this may affect its functionality.
•
Do not rotate the valve or excessively push/pull it when attaching or removing it. Also do not apply an excessive force to the endoscope’s cylinder when attaching or removing the valve. Otherwise, the valve mechanism may be damaged.
Attaching the suction valve (MAJ-1443) 1. Attach the suction valve to the suction cylinder of the endoscope (see Figure 3.3).
2. Confirm that the valve fits properly without any bulging of the skirt. Suction valve
Skirt
Suction cylinder
Figure 3.3
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Chapter 3 Preparation and Inspection
Attaching the air/water valve (MAJ-1444) 1. Attach the air/water valve to the air/water cylinder of the endoscope (see Figure 3.4).
2. Confirm that the valve fits properly without any bulging of the skirt.
Air/water valve
Skirt
Air/water cylinder
Figure 3.4
The air/water valve may stick at first, but it should operate smoothly after it is depressed a few times.
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Chapter 3 Preparation and Inspection
3.4
Inspection of the functionality Inspection of the suction function (Suction valve) 1. Immerse the distal end of the insertion tube in sterile water and depress the suction valve till the first stop position. Confirm that water is continuously aspirated into the suction bottle on the suction pump.
2. Release the suction valve. Confirm that suction stops and the valve returns to its original position.
3. Remove the distal end from the water. Depress the suction valve till the first stop position and aspirate air for a few seconds to remove any water from the instrument channel.
Inspection of aspiration from the balloon (Suction valve) 1. Immerse the distal end of the insertion tube in sterile water and completely depress the suction valve. Confirm that water is continuously aspirated.
2. Release the suction valve. Confirm that suction stops and the valve returns to its original position.
3. Remove the distal end from the water.
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Chapter 3 Preparation and Inspection
Inspection of the air feeding function (Air/water valve) 1. Switch the airflow regulator of the light source to “High”, as described in the light source’s instruction manual.
2. Immerse the distal end of the insertion tube in sterile water to a depth of 10 cm. Confirm that no air bubbles are emitted when the air/water valve is not operated.
3. With the distal end immersed to a depth of 10 cm, cover the air/water valve hole with your finger and confirm that air bubbles are continuously emitted from the air/water nozzle.
4. Uncover the air/water valve hole and confirm that no air bubbles are emitted from the air/water nozzle. Immerse the distal end of endoscope more than 10 cm below the surface of sterile water. If a stream of bubbles is continuously emitted from the air/water nozzle even though the air/water valve hole is not covered, an irregularity in the air feeding function may be suspected. If such an endoscope is used for examination, excessive insufflation in the body cavity may cause patient pains or perforation. If air bubbles are continuously emitted from the air/water nozzle, remove and reattach the air/water valve correctly or replace it with another one. If this fails to stop air bubbles from being emitted, there may be a malfunction with the endoscope. Do not use it and contact Olympus to have it serviced.
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Chapter 3 Preparation and Inspection
•
When the distal end of the insertion tube is immersed less than 10 cm below the surface of the sterile water, a small amount of air bubbles may be emitted from the air/water nozzle even when the air/water valve is not operated. This does not indicate a malfunction.
•
If no air bubbles are emitted after correctly inserting or exchanging the air/ water valve, the endoscope is operating correctly.
Inspection of the objective lens cleaning function (Air/water valve) 1. Keep the air/water valve’s hole covered with your finger and depress the valve till the first stop postion. Observe the endoscopic image and confirm that water is emitted from the air/water nozzle.
2. Release the valve. Observe the endoscopic image and confirm that the emission of water stops and the valve returns smoothly to its original position.
3. While observing the endoscopic image, feed air after feeding water by covering the hole in the air/water valve with your finger. Confirm that the emitted air dries the objective lens and clears the endoscopic image.
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Chapter 3 Preparation and Inspection
•
If the air/water valve returns to its original position slowly after water feeding, remove the air/water valve and moisten the seals with sterile water.
•
When the air/water valve is depressed for the first time, it may take a few seconds before water is emitted.
•
During the inspection, place the distal end of the endoscope in a beaker or other container so that the floor does not get wet.
Inspection of the water feeding function into the balloon (Air/water valve) Cover the air/water valve hole and completely depress the valve. Confirm that water is emitted through the balloon water supply port. It may take a few seconds to emit water when the air/water valve is depressed for the first time.
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