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INSTRUCTIONS Forceps/Irrigation Plug (Isolated Type)
MAJ-891
Contents
Contents Symbols...
1
Important Information - Please Read Before Use...
2
Intended purpose ... Contraindication ... Clinical benefit ... Instruction manual ... User qualifications ... Instrument compatibility ... Reprocessing and storage ... Repair and modification ... Signal words ...
2 2 2 3 3 4 4 4 5
Chapter 1
Checking the Package Contents...
6
Chapter 2
Instrument Nomenclature and Specifications ...
7
Nomenclature and functions ... Specifications...
7 8
2.1 2.2
Chapter 3 3.1 3.2 3.3 3.4 3.5
Preparation and Inspection ...
9
Preparation and inspection ... Assembly ... Attaching the forceps/irrigation plug to the endoscope ... Inspection of the irrigation function ... Inspection of the combination with the endo-therapy accessory ...
10 11
Chapter 4 4.1 4.2 4.3
12 14 15
Operation ... 17
Irrigation... Insertion of the endo-therapy accessory... Withdrawal of the endo-therapy accessory...
Forceps/Irrigation Plug (Isolated Type) MAJ-891
18 18 19
i
Contents
Chapter 5 5.1 5.2
Instructions ... Precautions...
Chapter 6 6.1 6.2 6.3 6.4 6.5 6.6
24 25 26 27 27 29
Cleaning, Disinfection and Sterilization Procedures ... 31
Required reprocessing equipment... Disconnect the forceps/irrigation plug... Disassembling the forceps/irrigation plug ... Cleaning... Disinfection/sterilization ...
31 32 32 34 35
Chapter 8
Storage ... 40
Chapter 9
Troubleshooting ... 41
9.1
ii
20 21
Compatible Reprocessing Methods and Chemical Agents ... 24
Compatibility summary ... Detergent solution... Disinfectant solution... Rinsing water ... ETO gas sterilization... Steam sterilization (autoclaving)...
Chapter 7 7.1 7.2 7.3 7.4 7.5
Reprocessing: General Policy... 20
Troubleshooting guide ...
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Symbols
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 instrument are as follows:
Refer to instructions.
Manufacturer
Authorized representative in the European Community
Lot number
Serial number
Date of Manufacture
Medical device
Translation
Importer (into European Union)
Forceps/Irrigation Plug (Isolated Type) MAJ-891
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Important Information - Please Read Before Use
Important Information - Please Read Before Use Intended purpose This instrument has been designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories. Electrosurgical accessories can be used only with Olympus endoscopes that are compatible with electrosurgery. Do not use this instrument for any purpose other than its intended use.
Contraindication None known.
Clinical benefit Supports to achieve the clinical benefit of the compatible Olympus endoscopes by providing functions that enable both irrigation and the use of EndoTherapy accessories.
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Forceps/Irrigation Plug (Isolated Type) MAJ-891
Important Information - Please Read Before 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 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 If there are official standards for user qualifications to perform endoscopy and endoscopic treatment that are defined by the healthcare facility’s medical administrators or other official institutions, such as academic societies on endoscopy, follow those standards. If there are no official qualification standards, the operator of this instrument must be a physician approved by the medical safety manager of the healthcare facility or person in charge of the department. The physician should be qualified to operate and perform safety the planned endoscopy and endoscopic treatment following guidelines set by the academic societies on endoscopy, etc., and considering the difficulty of endoscopy and endoscopic treatment.
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Important Information - Please Read Before Use
Instrument compatibility This instrument is compatible with Olympus endoscopes that have an instrument channel port. Only use electrosurgical accessories with Olympus endoscopes that are compatible with electrosurgery. Failure to do so can result in patient injury and/or equipment damage.
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: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures”. After using this instrument, 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 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. 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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Forceps/Irrigation Plug (Isolated Type) MAJ-891
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.
Precautions In case any serious incident happens to User or Patient while operating the device, the incident should be reported to Olympus and the competent authority of the respective member state or country.
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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 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: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures”.
Forceps/irrigation plug (isolated type, MAJ-891)
Biopsy valve (MAJ-579), 10 pieces
Forceps/irrigation plug (isolated type, MAJ-891) Instruction manual
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Forceps/Irrigation Plug (Isolated Type) MAJ-891
Chapter 2 Instrument Nomenclature and Specifications
Chapter 2
2.1
Instrument Nomenclature and Specifications
Nomenclature and functions Forceps/irrigation plug (isolated type, MAJ-891)
Irrigation port Lever Stopper Stopcock
Biopsy valve (MAJ-579)
Open
Forceps port
Close Covering
Side view Disconnect Tightening ring Tightening this ring prevents irrigation fluid from leaking. Turn towards “” to loosen, “” to tighten.
Connect
Locking ring Turning this ring connects/disconnects the forceps/irrigation plug to/from the endoscope.
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Chapter 2 Instrument Nomenclature and Specifications
2.2
Specifications Operating environment Ambient temperature
10 – 40C (50 – 104F)
Relative humidity
30 – 85%
Air pressure
700 – 1060 hPa (0.71 – 1.08 kgf/cm2) (10.1 – 15.4 psia)
Specifications Compatible Olympus
Endo-therapy accessories for ø
endo-therapy accessories
1.2 to 2.6 mm channels
The compatible endo-therapy accessories vary depending on the endoscope in use. Refer to the instruction manual of your endoscope to determine the endo-therapy accessories that are compatible with it. Medical Devices
This device complies with the
Regulation
requirements of regulation (EU) 2017/745 concerning medical devices. Classification: Class I
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Forceps/Irrigation Plug (Isolated Type) MAJ-891
Chapter 3 Preparation and Inspection
Chapter 3
Preparation and Inspection •
Before each case, prepare and inspect the instrument as instructed below. Inspect other equipment to be used with the instrument as instructed in their respective instruction manuals. Should the slightest irregularity be suspected, do not use the instrument; contact Olympus. Damage or irregularity of the forceps/irrigation plug may compromise patient or user safety and may result in more severe equipment damage.
•
The forceps/irrigation plug 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: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures”. Failure to do so could pose an infection control risk and/or cause tissue irritation.
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Chapter 3 Preparation and Inspection
3.1
Preparation and inspection Clean, disinfect and sterilize the forceps/irrigation plug as described in Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures”. A damaged or deformed biopsy valve can reduce the efficacy of the endoscope’s irrigation system and may cause patient debris to leak from the endoscope. The biopsy valve (MAJ-579) is a consumable item. If the biopsy valve is damaged or deformed, replace it with a new one.
1. Confirm that there is no damage, deformation or cracks on the plastic parts (black) and metallic parts of the forceps/irrigation plug and that it is free of debris.
2. Confirm that there are no breaks or deformation on the biopsy valve.
3. Confirm that there are no breaks or deformation on the covering of the locking ring. Do not use the forceps/irrigation plug if any damage, deformation or cracks are observed. Otherwise, operator and/or patient injury may result when using electrosurgical accessories.
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Forceps/Irrigation Plug (Isolated Type) MAJ-891
Chapter 3 Preparation and Inspection
3.2
Assembly 1. Attach the biopsy valve to the housing (see Figure 3.1).
2. Position the tightening ring over the biopsy valve and thread the tightening ring onto the housing so that the ends of the tightening ring and biopsy valve are aligned (see Figure 3.2).
3. Insert the stopcock into the main body until it stops (see Figure 3.1). Using the forceps/irrigation plug with the stopcock improperly inserted can reduce the efficacy of the endoscope’s irrigation system and may cause patient debris to leak from the endoscope.
Forceps/irrigation plug (isolated type) Tightening ring
Stopcock
Biopsy valve Main body Housing Locking ring
Instrument channel port
Figure 3.1
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Chapter 3 Preparation and Inspection
Tightening ring
Biopsy valve
Ends
Figure 3.2
3.3
Attaching the forceps/irrigation plug to the endoscope 1. Align the locking ring with the instrument channel port of the endoscope and turn it in the “Connect” direction until it stops, while gently pressing it against the instrument channel port of the endoscope (see Figure 3.3).
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Forceps/Irrigation Plug (Isolated Type) MAJ-891
Chapter 3 Preparation and Inspection
Instrument channel port
Instrument channel port cannot be seen. (Except for CHF-BP30)
Figure 3.3
Be sure to attach the forceps/irrigation plug securely. Incomplete attachment can reduce the efficacy of the endoscope’s irrigation system and may cause patient debris to leak from the endoscope.
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Chapter 3 Preparation and Inspection
3.4
Inspection of the irrigation function Do not connect a metal connector to the irrigation port on the forceps/irrigation plug. If the metal connector is connected, irrigation port damage, operator and/or patient injury may occur when using electrosurgical accessories.
1. Connect the irrigation tube from the irrigation system to the irrigation port on the forceps/irrigation plug.
2. Fully open the stopcock by turning the lever 90 degrees, so that it is perpendicular to the housing of the forceps/irrigation plug. Confirm that the lever moves smoothly and that irrigation fluid is emitted from the instrument channel opening at the distal end of the endoscope.
3. Fully close the stopcock by turning the lever 90 degrees in the opposite direction, so that it is parallel to the housing of the forceps/irrigation plug. Confirm that irrigation stops and that there is no water leakage from any part of the forceps/irrigation plug.
4. Fully open the stopcock, cover the instrument channel opening at the distal end of the endoscope with your finger, and confirm that there is no water leakage from any part of the forceps/irrigation plug.
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Forceps/Irrigation Plug (Isolated Type) MAJ-891
Chapter 3 Preparation and Inspection
If irrigation fluid leaks from the forceps port when an endo-therapy accessory is not used, turn the tightening ring so that the ends of the tightening ring and biopsy valve are aligned (see Figure 3.2). If fluid still leaks from the forceps port, the biopsy valve is worn out. Replace it with a new one.
3.5
Inspection of the combination with the endo-therapy accessory •
Keep your eyes away from the distal end when inserting endo-therapy accessories.
•
Confirm that the tip of the endo-therapy accessory is closed or retracted into its sheath and slowly insert it into the forceps port. Do not open the tip of the endo-therapy accessory or extend its tip from its sheath while inserting it into the channel. The endoscope and/or the endo-therapy accessory may become damaged.
•
Hold the endo-therapy accessory close to the forceps port and insert it straight into the forceps port using slow, short strokes. Otherwise, its sheath could bend or break.
1. Turn the tightening ring so that the ends of the tightening ring and biopsy valve are aligned (see Figure 3.2).
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Chapter 3 Preparation and Inspection
•
The endo-therapy accessory cannot be inserted if the end of the biopsy valve is projecting from that of the tightening ring.
•
If the tightening ring is loosened excessively, it may fall off of the housing.
2. Insert the distal end of the endo-therapy accessory into the forceps port and confirm that it passes smoothly.
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Forceps/Irrigation Plug (Isolated Type) MAJ-891
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 this instrument. •
Wear personal protective equipment to guard against dangerous chemicals and potentially infectious material. During operation, wear appropriate protective equipment, such as eye wear, a face mask, moisture-resistant clothing and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed.
•
Only use electrosurgical accessories with Olympus endoscopes that are compatible with electrosurgery. Failure to do so can result in patient injury or equipment damage.
•
Don’t turn the housing when the forceps/irrigation plug is attached to the instrument channel port of the endoscope. Failure to do so can result in the forceps/irrigation plug’s locking.
•
To disconnect the forceps/irrigation plug, hold only the locking ring, and loosen it until it comes off the endoscope. Do not turn the plug’s housing, as it may damage the plug and the endoscope.
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