AUXILIARY WATER TUBE Instructions

8 Package Contents and Specifications

Instruction manual Total length

Auxiliary water tube MAJ-2021

1150 mm

Medical Devices Directive

This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class II a

9 Preparation and Inspection Before each case, prepare and inspect this instrument as instructed below. Inspect other equipment used with this instrument as instructed in their respective instruction manuals. • • •

9.1

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 11, “Reprocessing”. Should the slightest irregularity be observed, do not use it. If the auxiliary water tube is damaged, replace it with a new one. Note that the luer port on the MAJ-2021 includes a one-way valve to prevent backflow – do not use the MAJ-2021 without this connector in place, otherwise backflow of contaminated material may occur and equipment damage or patient injury may result.

Inspection of the equipment

Confirm that the auxiliary water tube is free from cracks, scratches, flaws, and other damages. Do not disassemble or modify this instrument; patient injury and/or infection may result.

9.2

Preparation and inspection of related equipment

Prepare and inspect the endoscope, water pump and other equipment according to their respective instruction manuals.

9.3

Inspection of auxiliary water feeding function

1. When the auxiliary water inlet is sealed by the auxiliary water inlet cap (MAJ-215), remove the cap (see Figure 1). 2. Connect the auxiliary water tube to the auxiliary water inlet (see Figure 1). 3. Attach a syringe containing sterile water or the water tube on the water pump to the luer port of the auxiliary water tube. Feed water and confirm that water is emitted from the auxiliary water channel at the distal end of the insertion tube (see Figure 2).

4. Make sure that no water leaks at the connection from the auxiliary water tube to the auxiliary water inlet. 5. Make sure that no water leaks at the connection from the auxiliary water tube to the syringe or the water tube on the water pump.

6. Disconnect the syringe or the water tube on the water pump from the luer port of the auxiliary water tube. Make sure that no water leaks at the luer port of the auxiliary water tube and the distal end of the insertion tube. If the auxiliary water channel is used for feeding water, do not detach the auxiliary water tube from the auxiliary water inlet until the endoscope is precleaned. If the auxiliary water tube is detached before precleaning, water remaining in the auxiliary water channel may be spilled on the surrounding equipment. This could cause damage and/or malfunction of the equipment. To prevent channel clogging, use sterile water only.

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Luer port

Auxiliary water tube

Auxiliary water inlet

Syringe or water tube on the water pump

Auxiliary water inlet cap (MAJ-215) Auxiliary water tube

Endoscope connector

Figure 2

Figure 1

10 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 this instrument.

10.1 Auxiliary water feeding • •

Use sterile water only. Using nonsterile water can result in growth of bacteria or channel clogging, and this could pose an infection control risk and tissue irritation. Always use a cleaned and disinfected or sterile auxiliary water tube. Do not detach the auxiliary water tube before precleaning. If the auxiliary water tube is detached before precleaning, water remaining in the auxiliary water channel may be spilled on the surrounding equipment. This could cause damage and/or malfunction of the equipment.

1. Attach a syringe containing sterile water or the water tube on the water pump to the luer port of the auxiliary water tube. Feed water.

2. To disconnect the syringe or the water tube on the water pump from the auxiliary water tube during an exam, remove it from the luer port.

10.2 Transportation of the endoscope Transporting within the hospital If the auxiliary water tube is connected to the auxiliary water inlet, attach the clip of the auxiliary water tube to the universal cord (see Figure 3).

Clip

Figure 3

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11 Reprocessing Refer to the instruction manual for the endoscope to which the auxiliary water tube is connected for compatible reprocessing methods and chemical agents. • •

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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 this chapter. Failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each examination can compromise patient safety. To minimize the risk of transmitting diseases from one patient to another, after each examination this instrument must undergo thorough manual cleaning followed by high-level disinfection or sterilization. If this instrument is not cleaned meticulously, effective disinfection or sterilization may not be possible. Clean this instrument thoroughly before disinfection or sterilization to remove microorganisms or organic material that could reduce the efficacy of disinfection or sterilization. Patient debris and reprocessing chemicals are hazardous. Wear personal protective equipment to guard against dangerous chemicals and potentially infectious material. During cleaning and disinfection or sterilization, wear appropriate personal protective equipment, such as 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. Always remove contaminated personal protective equipment before leaving the reprocessing area. Thoroughly rinse off the disinfectant solution. Rinse the external surface and channel of the instrument thoroughly with rinse water to remove any disinfectant solution residue. The disinfection/sterilization room must be adequately ventilated. Adequate ventilation protects against the buildup of toxic chemical fumes. Store alcohol in an air-tight container. Alcohol stored in an open container is a fire hazard and will lose its efficacy due to evaporation.

11.1 Compatibility summary This instrument is compatible with several methods of reprocessing. However, not all reprocessing methods are compatible with the auxiliary water tube. Reprocessing with incompatible methods can cause equipment damage even if the number of reprocessing cycles is small. For appropriate reprocessing methods, refer to Table 1. Follow the policies at your local institution when choosing which methods listed in Table 1 to employ. For sterilization

Steam sterilization (autoclaving) Ethylene oxide gas sterilization (gas mixture 20% ethylene oxide gas/80% CO2, for countries other than the USA) Ethylene oxide gas sterilization (100% ethylene oxide gas) ACECIDE disinfectant solution1

For disinfection

2 – 3.5% glutaraldehyde For alcohol flush

70% ethyl or 70% isopropyl alcohol

For cleaning

Detergent solution Ultrasonic cleaning

Auxiliary water tube (MAJ-2021)

compatible

not compatible

Table 1 1

ACECIDE disinfectant solution is exclusively for an Olympus-recomended endoscope reprocessor, such as OER-AW and OER-Pro (ACECIDE may not be available in some areas).

Alcohol is not a sterilant or high-level disinfectant.

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Methods listed as “compatible” in Table 1 are compatible for routine use only when used according to manufacturer’s instructions. Repeated use and reprocessing of endoscopes and accessories leads to gradual wear and tear. But reprocessing methods that employ higher temperatures and more caustic/corrosive materials may lead to faster deterioration. In general, sterilization processes are harsher on equipment than disinfection processes. Before each patient procedure, inspect this instrument for damage, according to the instructions described in this manual. Alcohol is flammable. Handle with care.

Water (for reprocessing) Water is used for manual cleaning of the instrument. For this purposes, use either fresh, potable water or water that has been processed (e.g., filtered, deionized or purified) to improve its chemical and/or microbiological quality. Consult with your hospital’s infection control committee. When rinsing the instrument following disinfection, use the water as described in “Rinse water”.

Detergent solution • •

Excessive foaming prevents detergent from properly contacting the surfaces and channel walls of the auxiliary water tube, and may impair effective cleaning. Do not reuse detergent solutions.

Use a medical-grade, low-foaming, pH neutral detergent. Follow the instructions provided by the detergent manufacturer regarding concentration, temperature, contact time, and expiration date.

Disinfectant solution Use a high-level disinfectant declared by your national regulatory agency for use in reprocessing flexible endoscopes. Follow the disinfectant manufacturer’s instructions regarding activation (if required), concentration, temperature, contact time and expiration date. For further information regarding the compatibility of glutaraldehyde-based or non glutaraldehyde-based disinfectant solutions, contact Olympus.

Rinse water Some national or professional guidelines recommend using sterile water for rinsing the instrument. If sterile water is not available, these guidelines recommend using potable tap water and flushing the channels of the instrument with alcohol. If these guidelines are applicable to your institution, use sterile water for rinsing the instrument following disinfection. If sterile water is not available, use either fresh, potable water or water that has been processed (e.g., filtered, deionized, or purified) to improve its chemical and/or microbiological quality, and flush the channels of the instrument with the alcohol as described in “Alcohol” after rinsing. Consult with your hospital’s infection control committee regarding local policies on water quality. Some other national or professional guidelines recommend using water of at least drinking quality to remove disinfectant solution, and preferably sterile water for the final rinse. These guidelines also recommend drying the channels of the instrument with compressed filtered air at each reprocessing procedure and with alcohol at the end of the day. In case these guidelines are applicable to your institution, use sterile water and/or either fresh, potable tap water or water that has been processed (e.g., filtered, deionized, or purified) to improve its chemical and/or microbiological quality. Consult with your hospital’s infection control committee regarding local policies on water quality and the use of alcohol.

Alcohol Use medical-grade 70% ethyl or 70% isopropyl alcohol.

Steam sterilization (autoclaving) This instrument can be sterilized by steam within the parameters given in Table 2. When steam sterilizing, follow all national, professional and institutional reprocessing protocols as well as the instructions provided by the manufacturer of your sterilization equipment. Exceeding the recommended parameters may damage this instrument (see Table 2). Process Prevacuum

Parameters

Temperature

132 – 134C (270 – 274C)

Exposure time

5 minutes

Table 2

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11.2 Required reprocessing equipment • • • • • • • • •

Personal protective equipment Soft brush Clean, lint-free cloths Basins Detergent solution Clean water Disinfectant solution Sterile water (or nonsterile water) 70% ethyl or isopropyl alcohol

11.3 Precleaning of the endoscope Preclean the auxiliary water channel according to the procedures given below. Refer to the instruction manual for the endoscope to which the auxiliary water tube is connected for all other instructions on endoscope reprocessing.

Flush the auxiliary water channel Make sure to reprocess the auxiliary water tube MAJ-2021, even if not used. The auxiliary water channel must be flushed either manually or using an Olympus flushing pump (Endoscopic Flushing Pump OFP). The auxiliary water inlet cap (MAJ-215) should remain attached to the endoscope at all times, including during reprocessing of the endoscope. The cap of the auxiliary water inlet is required to remain open during reprocessing.

Auxiliary water inlet Auxiliary water inlet cap

Figure 4

 Manual flushing 1. Confirm the auxiliary water tube (MAJ-2021) is attached to the auxiliary water inlet of the endoscope. (If an auxiliary water tube was not used during the prior patient procedure, attach a clean auxiliary water tube to the endoscope.)

2. Immerse the distal end of the insertion section in the water. 3. Fill and attach a clean 30 ml syringe to the luer port of the auxiliary water tube and flush the auxiliary water channel with 30 ml of the water.

4. Detach the syringe from the luer port. Leave the auxiliary water tube attached to the endoscope.

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 Flushing using the flushing pump (OFP or OFP-2) 1. Confirm the auxiliary water tube (MAJ-2021) is attached to the auxiliary water inlet of the endoscope. Confirm the filter and the irrigation tube of the flushing pump are attached to the luer port of the auxiliary water tube. (If these items are not used during the patient procedure, attach them according to the instructions of the pump.)

Auxiliary water tube (MAJ-2021)

Luer port

OFP or OFP-2 (Filter and irrigation tube)

Auxiliary water inlet cap Auxiliary water inlet

Figure 5

2. Immerse the distal end of the insertion section in the water. 3. Activate the pump and set it to maximize the water flow according to the OFP or OFP-2 instructions, and flush the auxiliary water channel with water from the OFP or OFP-2 fluid container for 10 seconds.

4. Detach the filter and the irrigation tube from the auxiliary water tube. Leave the auxiliary water tube attached to the endoscope.

11.4 Cleaning, disinfection, and sterilization Cleaning 1. Fill a basin with water and detergent solution at the temperature and concentration recommended by the detergent manufacturer. Use a basin which is deep enough to allow the auxiliary water tube to be completely immersed.

2. Detach the auxiliary water tube from the endoscope. 3. Immerse the auxiliary water tube in the detergent solution. Using a clean, soft brush or lint-free cloth, meticulously clean all external surfaces in the detergent solution.

4. Attach a 30 cm3 (30 ml) syringe to the luer port of the auxiliary water tube and flush the tube thoroughly with detergent solution.

5. Soak the auxiliary water tube for the amount of time and at the temperature recommended by the detergent manufacturer.

6. Remove the auxiliary water tube from the detergent solution and place it in clean water. 7. Inspect the auxiliary water tube. If debris remains, ultrasonically clean at 38 – 47 kHz for 5 minutes. 8. Attach a 30 cm3 (30 ml) syringe to the luer port of the auxiliary water tube and flush the tube with water. 9. Remove the auxiliary water tube from the clean water. 10. Attach a 30 cm3 (30 ml) syringe to the luer port of the auxiliary water tube and flush air to remove the water. 11. Use a clean, lint-free cloth to thoroughly wipe and dry the external surfaces of the auxiliary water tube.

High-level disinfection 1. Fill a basin with disinfectant solution at the temperature and concentration recommended by the disinfectant manufacturer. Use a basin which is deep enough to allow the auxiliary water tube to be completely immersed.

2. Immerse the auxiliary water tube in the disinfectant solution. 3. Attach a 30 cm3 (30 ml) syringe to the luer port of the auxiliary water tube and flush the tube with disinfectant solution. Ensure that all air bubbles are expelled.

4. Using a lint-free cloth or 30 cm3 (30 ml) syringe, wipe and/or flush all surfaces with disinfectant solution to remove all air bubbles.

5. Soak the auxiliary water tube for the amount of time and at the temperature recommended by the disinfectant manufacturer.

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Rinsing after high-level disinfection  Sterile water rinse 1. Fill a basin with sterile water. Use a basin which is deep enough to allow the auxiliary water tube to be completely immersed.

2. Remove the auxiliary water tube from the disinfectant solution and attach a 30 cm3 (30 ml) syringe. Flush air to expel all disinfectant solution. Immerse the auxiliary water tube in the sterile water.

3. Attach a 30 cm3 (30 ml) syringe to the luer port of the auxiliary water tube and flush the tube with sterile water. 4. Gently agitate the auxiliary water tube to thoroughly rinse it. 5. Remove the auxiliary water tube from the sterile water. 6. Attach a 30 cm3 (30 ml) syringe to the luer port of the auxiliary water tube and flush air to dry the inside of the tube. 7. Use a sterile, lint-free cloth to thoroughly wipe and dry all external surfaces. Flushing the channels with 70% ethyl or isopropyl alcohol after rinsing with sterile water facilitates drying the inside of the channels.

 Nonsterile water rinse and alcohol flush 1. Fill a small container with 70% ethyl or isopropyl alcohol. 2. Inject nonsterile water and air following the procedures given in “Sterile water rinse” above. 3. Attach a 30 cm3 (30 ml) syringe to the luer port of the auxiliary water tube and flush the tube with alcohol. 4. Immerse the auxiliary water tube in the alcohol and gently agitate it. 5. Remove the auxiliary water tube from the alcohol. 6. Attach a 30 cm3 (30 ml) syringe to the luer port of the auxiliary water tube and flush air to dry the inside of the tube. 7. Use a sterile, lint-free cloth to thoroughly wipe and dry all external surfaces.

Sterilization Sterilize this instrument using the same methods used for the sterilization of the reusable parts and reprocessing equipment of the endoscope. Refer to the instruction manual for the endoscope to which the auxiliary water tube is connected for sterilization.

12 Reprocessing using an Automated Endoscope Reprocessor The instrument is compatible with an endoscope reprocessor (OER-AW, OER-Pro). Refer to the instruction manual for the endoscope reprocessor for details on operation. •

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If using an endoscope reprocessor (OER-AW, OER-Pro), the instrument can be reprocessed only with the OLYMPUS ultrasound endoscope (OER-AW and OER-Pro may not be available in some areas). Otherwise, insufficient cleaning and/or disinfection of the instrument may pose an infection control risk to the patient and/or operators performing the next procedure. Thoroughly clean the endoscope as described in Chapter 11, “Reprocessing” before reprocessing the endoscope in an endoscope reprocessor. If a MAJ-2021 that has not been thoroughly manually cleaned is placed into the endoscope reprocessor, debris attached to the MAJ-2021 may impair the cleaning and disinfection capabilities of the reprocessor, and the MAJ-2021 can pose an infection control risk to the patient and/or operators who perform the next procedure with it. Note that if the instrument is not precleaned immediately after the procedure, patient debris may solidify, which could impair proper cleaning and disinfection of the MAJ-2021. Olympus only confirms validation of endoscope reprocessors it recommends. When using an endoscope reprocessor that is not recommended by Olympus, the endoscope reprocessor’s manufacturer is responsible for validation of the reprocessor with the endoscope models listed in this instruction manual. When cleaning and disinfecting an MAJ-2021 in an endoscope reprocessor, use connectors/adaptors that are specifically compatible with the MAJ-2021. Otherwise, insufficient cleaning and disinfection or sterilization of the MAJ-2021 may occur, which could pose an infection control risk to the patient and/or operators performing the next procedure with the MAJ-2021. The applicable connectors for MAJ-2021 should be listed in the instruction manual for the endoscope reprocessor. If using the endoscope reprocessor (OER-AW, OER-Pro), the MAJ-2021 can not be reprocessed with any other endoscopes except TGF-UC180J. Only one unit of the MAJ-2021 can be reprocessed with one unit of TGF-UC180J. Otherwise, insufficient cleaning and/or disinfection of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the MAJ-2021.

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If using the endoscope reprocessor recommended by Olympus, be sure to attach the appropriate cleaning/connecting tube (see Table 3). Otherwise, insufficient cleaning and disinfection of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the MAJ-2021. The applicable connectors for the MAJ-2021 should be listed in the instruction manual for the endoscope reprocessor or in Table 3. If the endoscope and endoscope reprocessor is not listed in the instruction manual or in Table 3, please contact Olympus. OER-AW

MAJ-1515

OER-Pro

MAJ-1515

Table 3 Be sure to attach all required connectors to MAJ-2021. For details concerning appropriate connectors, refer to the instructions of the AER manufacturer. Manually clean and disinfect or sterilize MAJ-2021 which is not compatible with the AER.

13 Storage and Disposal 13.1 Storage The storage cabinet must be clean, dry, well ventilated and maintained at ambient temperature. Storing the auxiliary water tube in direct sunlight, at high temperatures, in high humidity, or exposed to X-rays may damage the auxiliary water tube or present an infection control risk. Before storing a high-level disinfected or sterilized auxiliary water tube, thoroughly dry the auxiliary water tube.

13.2 Disposal When disposing of this instrument, handle it in a manner which will prevent the spread of contamination from the reprocessing area, and follow all applicable national and local laws regarding disposal.

14 Appendix System chart

Flushing pump (OFP-2, OFP)

Auxiliary water tube (MAJ-2021)

Ultrasound endoscope (TGF-UC180J)

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Environment Operating environment

Standard storage environment (e.g. within the hospital)

Transportation and storage environment

Ambient temperature

10 – 40C (50 – 104F)

Relative humidity

30 – 85%

Atmospheric pressure

700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)

Ambient temperature

5 – 40C (41 – 104F)

Relative humidity

10 – 95% (without condensation)

Atmospheric pressure

700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)

Ambient temperature

–47 to +70C (–52.6 to +158F)

Relative humidity

10 – 95%

Atmospheric pressure

700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)

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Manufactured by 2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan Fax: (042)646-2429 Telephone: (042)642-2111

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RC0321 07

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