Instructions
40 Pages
Preview
Page 1
INSTRUCTIONS
WATER CONTAINER
MAJ-902
AUTOCLAVABLE 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 ...
2
User qualifications ...
2
Instrument compatibility ...
2
Reprocessing and storage ...
3
Repair and modification ...
3
Signal words ...
3
Chapter 1
Checking the Package Contents...
4
Chapter 2
Instrument Nomenclature ...
5
Chapter 3
Preparation and Inspection ...
6
3.1
Preparation and inspection ...
8
3.2
Adjusting the gas pressure ...
11
3.3
Connecting to the endoscope ...
12
3.4
Disconnecting from the endoscope...
13
Chapter 4
Operation ...
15
Chapter 5
Reprocessing...
18
5.1
General policy ...
18
5.2
Compatible reprocessing methods and chemical agents ...
20
5.3
Required reprocessing equipment ...
22
5.4
Cleaning...
23
5.5
Disinfection and sterilization ...
26
Storage ...
29
6.1
Inspection before storage ...
29
6.2
Storage ...
30
Appendix ...
31
Operating environment ...
31
Specifications ...
31
Chapter 6
WATER CONTAINER MAJ-902
i
Contents
ii
WATER CONTAINER MAJ-902
Symbols
Symbols The meaning(s) of the symbol(s) shown on the package, the back cover of this instruction manual and/or this instrument are as follows:
Front side
Caution, refer to instructions.
Caution, refer to instructions.
Back cover of this instruction manual Manufacturer Authorized representative in the European Community
For US Customers only For a Symbols Glossary, visit us: http://www.olympus-global.com/en/common/pdf/symbolsglossary.pdf WATER CONTAINER MAJ-902
1
Important Information - Please Read Before Use
Important Information - Please Read Before Use Intended use This instrument has been designed to be used with endoscopes (EVIS EXERA series videoscope, 40 series endoscope) to allow gas insufflation and water feeding from the endoscope. Do not use this instrument for any purpose other than its intended use.
Instruction manual This instruction manual contains essential information on using this instrument 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 equipment 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 operator of this instrument 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.
Instrument compatibility This instrument is compatible with endoscopes (EVIS EXERA series videoscope, 40 series endoscope). Using incompatible equipment can result in patient injury and/or equipment damage.
2
WATER CONTAINER MAJ-902
Important Information - Please Read Before Use
Reprocessing and storage This instrument was not disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions given in Chapter 5, “Reprocessing”. After using this instrument, reprocess and store it according to the instructions given in Chapter 5, “Reprocessing” and Chapter 6, “Storage”. Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance.
Repair and modification This instrument does not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair it; patient or user injury and/or equipment damage can result.
Signal words The following signal words are used throughout this manual:
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.
WATER CONTAINER MAJ-902
3
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 the instrument is damaged, a component is missing or you have any questions, do not use the instrument; immediately contact Olympus. This instrument was not disinfected or sterilized before shipment. Before using the instrument for the first time, reprocess it according to the instructions given in Chapter 5, “Reprocessing”.
Instructions Water container (MAJ-902)
4
WATER CONTAINER MAJ-902
Chapter 2 Instrument Nomenclature
Chapter 2 Instrument Nomenclature Tube
Lid Gas tube connector Lid
CE marking
Tip receptacle
Water tube Hook O-ring
Lot No.
Metal tip Cleaning cap Specified water level marks
Caution tag
Container protector
Container Container Lowest water level line If the sterile water level falls below this line, water feeding may not be possible. Container protector
WATER CONTAINER MAJ-902
5
Chapter 3 Preparation and Inspection
Chapter 3 Preparation and Inspection
6
•
Before each case, prepare and inspect this instrument as instructed below. Inspect other equipment to be used with this instrument as described in the respective instruction manuals. Should the slightest irregularity be suspected, do not use this instrument; contact Olympus. Damage or irregularity may compromise patient or user safety and may result in more severe equipment damage.
•
This instrument was not disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions given in Chapter 5, “Reprocessing”. Failure to do so could pose an infection control risk and cause tissue irritation.
•
Never drop the water container or subject it to impacts. The container could become damaged, which could make air and/or water feeding impossible.
•
The water container is a consumable item. If inspection of the water container reveals any irregularities, use a new water container.
•
Do not bend, twist or pull the tube excessively. The tube could become damaged, which could make air and/or water feeding impossible.
•
The O-ring is subject to wear. Replace it with a new one whenever you detect damaged or deformed areas. Otherwise air and/or water feeding might be impossible.
•
To remove the O-ring, pull out the portion that lies in the notch along the container’s rim (see Figure 3.1). Attempting to pry the O-ring out of its groove could damage the O-ring and/or the container.
WATER CONTAINER MAJ-902
Chapter 3 Preparation and Inspection
Notch Groove
Container
Figure 3.1 •
Do not bend, pull or twist the water tube on the underside of the lid with excessive force (see Figure 3.2). Doing so could damage the water tube, making water feeding impossible.
•
Never detach the water tube from the lid (see Figure 3.2). Doing so could damage the water tube, making water feeding impossible.
Water tube
Figure 3.2
WATER CONTAINER MAJ-902
7
Chapter 3 Preparation and Inspection
3.1
Preparation and inspection 1. Referring to Chapter 2, “Instrument Nomenclature”, inspect the water container and all of its components. Confirm that all components free of damage or irregularities.
Securely fasten the gas cylinder and other equipment as instructed by the manufacturer. Equipment that has not been securely fastened may fall and cause disconnections and damage.
•
The gas cylinder, valve, regulator, relief valve, pressure gauge, flow meter, gas tube connector and tubes are not shipped with this product, and are generally delivered non-sterile. Clean, disinfect and/or sterileze these items as required before use.
•
Install a bactericidal filter between the flow meter and gas tube connector, if necessary.
•
Always prepare a spare gas cylinder for quick replacement in case the primary cylinder becomes empty during the procedure.
2. Prepare the gas cylinder, valve, regulator, relief valve, pressure gauge, flow meter, gas tube connector and tubes for connecting equipment. Connect all equipment as shown in Figure 3.3 and in accordance with their respective instruction manuals. Valve
Gas tube
Relief valve Valve
Flow meter
Regulator Pressure gauge Gas tube connector Gas cylinder
Figure 3.3
8
WATER CONTAINER MAJ-902
Chapter 3 Preparation and Inspection
3. Adjust the gas pressure as described in Section 3.2, “Adjusting the gas pressure”.
•
Never fill in the container with sterile water while holding it over electrical equipment. If water is spilled on or into the equipment, electrical shock or damage can result.
•
Use sterile water only. Using non-sterile water can result in growth of bacteria or channels clogging, and this could pose an infection control risk and tissue irritation.
Fill the container with sterile water to within the specified water level marks. If the container is not filled between these marks, water feeding will be inadequate.
4. Fill the container with sterile water until the water level is within the water level marks (see Figure 3.4) specified on the outside of the container.
Specified water level marks
Figure 3.4
WATER CONTAINER MAJ-902
9
Chapter 3 Preparation and Inspection
If the O-ring is not correctly attached and the lid is not closed properly, gas insufflation and water feeding may not be possible (see Figure 3.5).
5. Attach the lid to the container. Screwing the lid onto the container, the torque for screwing may grow. After that, screw the lid 180° clockwise.
O-ring
Container
Figure 3.5
6. Attach the container protector to the bottom of the container. Hang the hook of the water container on the water container holder of the light source or mobile workstation. Otherwise, the water container may fall and sterile water could be spilled on surrounding equipment. This could result in equipment damage and/or malfunction.
7. Hang the hook of the water container on the water container holder of the light source or mobile workstation.
8. Securely connect the gas tube to the gas tube connector on the lid of the water container.
9. Connect the metal tip of the water container to the endoscope as described in Section 3.3, “Connecting to the endoscope”.
10. Turn the light source ON and set the air flow regulator switch on the light source to “0” or “OFF”. Confirm that no air is being fed from the light source.
10
WATER CONTAINER MAJ-902
Chapter 3 Preparation and Inspection
11. Cover the small hole in the endoscope’s air/water valve with a finger wearing sterile gloves. Gradually open the regulator until the gas flow rate reaches 1000 cm3/min (1 l/min).
12. Inspect gas insufflation and water feeding as described in the endoscopic instruction manuals.
13. Close the regulator. To disconnect the metal tip of the water container from the endoscope, perform the procedure as described in Section 3.4, “Disconnecting from the endoscope”.
3.2
Adjusting the gas pressure Do not allow the pressure to exceed the preselected value of 50 kPa at any time during the procedure, and always monitor the pressure during the procedure. Otherwise, excess pressure can build up within the patient’s body cavity and cause injury. It can also damage the water container and/or the endoscope. Adjust the gas pressure in accordance with the following procedure.
1. After confirming that the regulator and relief valve are closed, open the gas cylinder’s valve.
2. Cover the gas tube connector opening with your fingers wearing sterile gloves. Gradually open the regulator until a pressure between 60 and 70 kPa is reached.
3. Keeping the gas tube connector opening covered, gradually open the relief valve until the pressure of 50 kPa is reached.
4. Turn the valve off at the regulator, but leave the gas tube connector open.
WATER CONTAINER MAJ-902
11
Chapter 3 Preparation and Inspection
3.3
Connecting to the endoscope •
Never drop the water container or subject it to impacts. The container could become damaged, which could make gas insufflation and water feeding impossible.
•
Do not bend, twist or pull the tube excessively. The tube could become damaged, which could make gas insufflation and water feeding impossible.
•
Connect the metal tip slowly and carefully. Otherwise, the metal tip could become damaged, which could make gas insufflation and water feeding impossible.
•
Push the metal tip straight onto the water supply connector on the endoscope. If connection to the endoscope is excessively angled, the metal tip may be damaged.
Connect the metal tip of the water container to the endoscope connector as described below (see Figure 3.6).
1. Push the metal tip’s water supply channel gently onto the water supply connector on the endoscope at an angle of 90° to the connector (see Figure 3.6).
2. Turn the metal tip 90° clockwise to align the air supply channel with the air supply connector of the endoscope (see Figure 3.6).
3. Gently press the metal tip to confirm that it is securely connected to the endoscope. Endoscope 1.
2.
3.
Turn 90° clockwise Air supply connector Water supply connector
Air supply channel Water supply channel
Figure 3.6
12
WATER CONTAINER MAJ-902
Metal tip
Chapter 3 Preparation and Inspection
3.4
Disconnecting from the endoscope •
Never drop the water container or subject it to impacts. The container could become damaged, which could make gas insufflation and water feeding impossible.
•
Do not bend, twist or pull the tube excessively. Otherwise, the tube could become damaged, which could make gas insufflation and water feeding impossible.
•
Disconnect the metal tip slowly and carefully. The metal tip could become damaged, which could make gas insufflation and water feeding impossible.
•
Pull the metal tip straight out. If connection to the endoscope is excessively angled, the metal tip may be damaged.
When disconnecting the metal tip of the water container from the endoscope, perform the following procedure slowly and carefully (see Figure 3.7).
1. Close the gas cylinder’s valve, then disconnect the gas tube connector from the gas tube connector on the lid of the water container.
2. Gently pull the metal tip off the air supply connector of the endoscope. 3. Turn the metal tip counterclockwise (90°). 4. Pull the metal tip straight off to completely disconnect it from the endoscope connector.
Endoscope 2.
3.
4.
Turn 90° counterclockwise
Figure 3.7
WATER CONTAINER MAJ-902
13
Chapter 3 Preparation and Inspection
Always keep disconnected metal tip above the water level in the container. Otherwise, water may drip or spill from the metal tip onto surrounding equipment, which may cause damage and malfunction.
5. Lift the disconnected metal tip upwards (see Figure 3.8). Metal tip Light source
Endoscope
Figure 3.8
6. Attach it to the tip receptacle on the lid (see Figure 3.9).
Tip receptacle
Light source
Figure 3.9
14
WATER CONTAINER MAJ-902
Chapter 4 Operation
Chapter 4 Operation The operator of this instrument 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. It only describes basic operation and precautions related to the operation of the instrument.
Maintain the water container daily. The water container should be emptied, cleaned and disinfected or sterilized at least once per day. Failure to do so could pose an infection control risk and/or cause tissue irritation.
•
Never drop the water container or subject it to impacts. The container could become damaged, which could make gas insufflation and water feeding impossible.
•
Do not bend, twist or pull the tube excessively. The tube could become damaged, which could make gas insufflation and water feeding impossible.
•
Before insufflating gas, set the light source’s air flow regulator switch to “0” or “OFF” to disable air feeding. Otherwise, a mixture of air and gas will be insufflated into the patient’s body cavity.
WATER CONTAINER MAJ-902
15
Chapter 4 Operation
1. Turn the light source ON and confirm that the air feed from the light source is stopped.
The gas is normally emitted through the small hole in the endoscope’s air/water valve. To prevent oxygen deficiency, ensure adequate ventilation.
2. While covering the small hole in the endoscope’s air/water valve with a finger wearing sterile gloves, gradually open the regulator until the gas flow rate reaches 1000 cm3/min (1 l/min).
3. Perform gas insufflation and water feeding as described in the endoscopic instruction manuals.
Never insufflate at a flow rate higher than 1000 cm3/min (1 l/min). This could not only damage the endoscope and the water container but could also result in over insufflating the patient.
4. While making sure that the gas flow rate does not exceed 1000 cm3/min (1 l/min), adjust the flow rate as necessary.
16
•
Monitor the water level carefully during the procedure and fill the water container with sterile water as necessary. Water feeding will stop when the water level falls below the lowest water level line.
•
The gas is normally emitted through the small hole in the endoscope’s air/water valve. When exchanging the air/water valve for the gas/water valve (MAJ-521), no gas will be emitted. When using the gas/water valve, please refer to its instruction manuals.
WATER CONTAINER MAJ-902
Chapter 4 Operation
5. Perform gas insufflation and water feeding as described in the instruction manuals for the gas/water valve and endoscope being used together with this water container. If the water level falls below the lowest water level line during use, disconnect the metal tip of the water container from the endoscope as described in Section 3.4, “Disconnecting from the endoscope” (see Figure 4.1). Then refill the water container with sterile water as described in Section 3.1, “Preparation and inspection”.
Lowest water level line
Figure 4.1
6. After each case, disconnect the metal tip of the water container from the endoscope as described in Section 3.4, “Disconnecting from the endoscope”. Then refill the water container with sterile water as described in Section 3.1, “Preparation and inspection”.
7. When the procedure is complete, close the gas cylinder’s valve if gas insufflation and water feeding are not necessary. When gas insufflation and water feeding required again, adjust the gas pressure as described in Section 3.2, “Adjusting the gas pressure”.
WATER CONTAINER MAJ-902
17