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INSTRUCTIONS
LOOP CUTTER
FS-5L/Q/U-1
AUTOCLAVABLE USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Contents
Contents Symbols...
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Important Information - Please Read Before Use 2 Intended Use ... Instruction Manual ... User Qualifications... Instrument Compatibility ... Reprocessing and Storage ... Repair and Modification ... Signal Words ...
Chapter 1 1.1
Checking the Package Contents...
5
Checking the Package Contents ...
5
Chapter 2 2.1 2.2
Instrument Nomenclature and Specifications ...
6
Nomenclature and Functions... Specifications...
6 7
Chapter 3 3.1 3.2 3.3
11 12 13
Reprocessing... 21
General Policy ... Required Reprocessing Equipment ... Cleaning... Lubrication ... Sterilization ...
Chapter 5 5.1 5.2
Preparation, Inspection and Operation ... 10
Preparation ... Inspection ... Operation ...
Chapter 4 4.1 4.2 4.3 4.4 4.5
2 2 2 3 3 3 4
21 24 26 28 29
Storage ... 32
Inspection Before Storage ... Storage ...
LOOP CUTTER FS-5L/Q/U-1
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Contents
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LOOP CUTTER FS-5L/Q/U-1
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:
Refer to instructions.
Manufacturer
Authorized representative in the European Community Lot number Keep away from sunlight
Keep dry This Product Contains No Natural Rubber Latex.
LOOP CUTTER FS-5L/Q/U-1
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Important Information - Please Read Before Use
Important Information - Please Read Before Use Intended Use This instrument has been designed to be used with an Olympus endoscope. It is used to cut the residual end of the Olympus Loop used for ligating tissue within the digestive tract. Do not use this instrument for any other purpose.
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 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.
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LOOP CUTTER FS-5L/Q/U-1
Important Information - Please Read Before Use
Instrument Compatibility Refer to the Table in Section 2.2, “Specifications” to confirm that this instrument is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury or equipment damage.
Reprocessing and Storage This instrument was not sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions in Chapter 4, “Reprocessing”. After using this instrument, reprocess and store it according to the instructions in Chapter 4, “Reprocessing” and Chapter 5, “Storage”. Improper and/or incomplete reprocessing can present an infection control risk, cause equipment damage or reduce performance.
Repair and Modification This instrument contains no user-serviceable parts. Do not disassemble, modify or attempt to repair; patient or user injury and equipment damage can result.
LOOP CUTTER FS-5L/Q/U-1
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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.
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LOOP CUTTER FS-5L/Q/U-1
Chapter 1 Checking the Package Contents
Chapter 1 1.1
Checking the Package Contents
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 sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions in Chapter 4, “Reprocessing”.
Loop Cutter
Instruction Manual
LOOP CUTTER FS-5L/Q/U-1
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Chapter 2 Instrument Nomenclature and Specifications
Chapter 2
2.1
Instrument Nomenclature and Specifications
Nomenclature and Functions
Lot Number (five digits) – Identification Number (four digits) The cutter can be individually recognized by an Identification Number. Ring
Slider Push the Slider to open the Cutter. Pull to close. A green reference label indicates that the instrument is autoclavable.
The color of the Ring indicates the minimum instrument channel diameter required for the endoscope to be compatible.
Handle Model Reference Label Indicates the product number.
Forceps Cap Prevents damage to the Distal End during transportation.
Cutter Cuts the Loop.
Insertion Portion/Working Length Made from a metallic coil.
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LOOP CUTTER FS-5L/Q/U-1
Chapter 2 Instrument Nomenclature and Specifications
Distal End
Loop Hanger
Cutter Cuts the Loop.
Holds the Loop when cutting.
Cutter Storage part
Blade
The Cutter is stored when pulled the slider.
2.2
Specifications The compatible Olympus endoscopes are listed in the Table on the following pages. New endoscopes released after the introduction of this instrument may also be compatible for use in combination with this instrument. For further details, contact Olympus. Use this instrument only in combination with products recommended by Olympus. If combined with products not recommended by Olympus, patient or operator injury, malfunction or equipment damage may result.
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)
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Chapter 2 Instrument Nomenclature and Specifications
Specifications Model
FS-5L-1
FS-5Q-1
Shape
Maximum Insertion
ø 2.4
Portion Diameter (mm) Working Length (mm)
1650
1950
Compatible
Model and
Working length
Working length
Olympus
Length
less than
less than
Endoscopes
1200 mm;
1500 mm;
(All of these
GIF, CF
GIF, CF
parameters
(Exclude I,
(Exclude
should be met.)
L-length), OGF,
L-length), PCF
OSF
(Only I-length), OGF, OSF
Channel Inner Diameter (mm) (Color Code)
8
ø 2.8, ø 3.2
ø 2.8, ø 3.2
(Yellow)
(Yellow)
ø 3.7, ø 6
ø 3.7, ø 4.2,
(Orange)
ø 6 (Orange)
LOOP CUTTER FS-5L/Q/U-1
Chapter 2 Instrument Nomenclature and Specifications
Model
FS-5U-1
Shape
Maximum Insertion
ø 2.4
Portion Diameter (mm) Working
2300
Length (mm) Compatible
Model and
Working length less than
Olympus
Length
1850 mm;
Endoscopes
GIF, CF, SIF (SIF-10 Only), OGF,
(All of these
OSF
parameters
Channel
should be met.)
Inner
ø 2.8, ø 3.2 (Yellow)
Diameter
ø 3.7, ø 4.2,
(mm)
ø 6 (Orange)
(Color Code)
Medical
This device complies with the
Devices
requirements of Directive
Directive
93/42/EEC concerning medical devices. Classification: Class I
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Chapter 3 Preparation, Inspection and Operation
Chapter 3
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Preparation, Inspection and Operation •
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 may compromise patient or user safety, such as punctures, hemorrhages or mucous membrane damage and may result in more severe equipment damage.
•
This instrument was not sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions in Chapter 4, “Reprocessing”. Do not use an instrument that has not been clean and sterilized. This poses an infection control risk and can cause tissue irritation.
•
Do not coil the Insertion Portion with a diameter of less than 15 cm. This could damage the Insertion Portion.
•
Never use excessive force to open or close the Cutter. This could damage the instrument.
LOOP CUTTER FS-5L/Q/U-1
Chapter 3 Preparation, Inspection and Operation
3.1
Preparation Equipment and Personal Protective Equipment Prepare all equipment and personal protective equipment which will be used with the instrument in accordance with their respective instruction manuals. Appropriate personal protective equipment may include: Eye wear, a face mask, moisture-resistant clothing and chemical-resistant gloves.
Spare Instrument Always have a spare instrument available.
Reprocessing Equipment Prepare reprocessing equipment as described in Section 4.2, “Required Reprocessing Equipment” for immediate reprocessing after use.
Emergency Equipment Always have sharp pliers on hand, to cut the loop cutter when it cannot be withdrawn from the patient.
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Chapter 3 Preparation, Inspection and Operation
3.2
Inspection Wear the personal protective equipment as specified in the Table on page 25. Before each case, always inspect the instrument according to the following procedures. If an abnormality in the instrument is detected, use a spare instrument, inspecting it thoroughly before use.
Inspection of the Sterile Package Inspect the sterile package for tears, inadequate sealing or water damage. If the sterile package shows any irregularities, the sterile condition of the instrument may have been compromised. Use a spare instead.
Appearance Inspection If any of following steps revels irregularities, do not use the instrument; use a spare instead.
1. While operating the Slider to open and close the Cutter, confirm that the instrument is free from disconnection or looseness.
2. Pull the Slider to make sure that the Cutter closes smoothly and that it is properly aligned with the Cutter Storage part.
3. Confirm that the Distal End of the instrument appears exactly as shown in the Tables in Section 2.2, “Specifications” and is not damage.
4. Make sure that the Blade is not broken or nicked. 5. Gently run your fingertips over the entire length of the Insertion Portion to check for any crushed areas, excessive bends or other damages.
6. Make sure that there are no cracks in the Handle. 12
LOOP CUTTER FS-5L/Q/U-1
Chapter 3 Preparation, Inspection and Operation
Inspection of Operation If the Cutter does not operate smoothly and as intended, do not use the instrument; use a spare instead.
1. Holding the instrument as shown in Figure 3.1, form a loop in the Insertion Portion approximately 20 cm in diameter. Open
Close
Approximately 20 cm
Figure 3.1
2. Operate the Slider and confirm that the Cutter opens and closes smoothly.
3.3
Operation The operator of the 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.
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Chapter 3 Preparation, Inspection and Operation
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•
When using the instrument, always wear appropriate personal protective equipment. Otherwise, blood, mucous and other potentially infections material from the patient could pose an infection control risk. Appropriate personal protective equipment may include: 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.
•
Do not insert the instrument into the endoscope unless you have a clear endoscopic field of view. If you cannot see the distal end of the Insertion Portion in the endoscopic field of view, do not use it. This could cause patient injury, such as punctures, hemorrhages or mucous membrane damage. It may also damage the endoscope and/or instrument.
•
Do not angulate the Bending Section of the endoscope while the Distal End of the Insertion Portion is extended from the distal end of the endoscope. This could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.
LOOP CUTTER FS-5L/Q/U-1
Chapter 3 Preparation, Inspection and Operation
•
Do not try to cut the Loop that is not positioned on both edges of the Loop Hanger as plumb as possible for the Blade. It may make cutting the Loop impossible, or result in the Loop getting caught in the Distal End of the instrument, which could make it difficult or impossible to remove from the patient. In this case, use pliers to cut the insertion portion of the instrument where it extends from the biopsy valve of the endoscope. Remove the endoscope from the body, then reinsert the endoscope and cut the Loop with a spare Loop Cutter.
•
Do not use the instrument to cut any objects other than the surplus of Olympus loop (e.g., MAJ-254, MAJ-340). If anything other than the surplus of the loop is cut, the blades may be damaged and unable to perform properly, the cut object may be caught in the tip of the instrument, and it may become difficult to safety remove the instrument from the body. Such objects other than the surplus of loop may include, stent wire, sewing threads, and loop stoppers. When using the instrument together with a two channel endoscope, never use electrosurgical accessories at the same time. This could result in thermal injury to the patient, operator or assistant.
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Chapter 3 Preparation, Inspection and Operation
Inserting Into the Endoscope
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•
Do not force the instrument if resistance to insertion is encountered. Reduce the angulation until the instrument passes smoothly. This could cause patient injury, such as punctures, hemorrhages or mucous membrane damage. It could also damage the endoscope and/or instrument.
•
When inserting the instrument into the endoscope, hold the Slider firmly. Otherwise, the Cutter may open and extend from the endoscope tip abruptly. This could cause patient injury, such as punctures, hemorrhages or mucous membrane damage. It could also damage the endoscope and/or instrument.
•
Do not advance or extend the instrument abruptly. This could cause patient injury, such as punctures, hemorrhages or mucous membrane damage. It could also damage the endoscope and/or instrument.
•
When inserting the instrument into the endoscope, hold it close to the Biopsy Valve and keep it as straight as possible relative to the Biopsy Valve. Otherwise, the Insertion Portion of the instrument could be damaged.
•
Insert the Loop Cutter slowly. Abrupt insertion could damage the endoscope and/or instrument.
LOOP CUTTER FS-5L/Q/U-1
Chapter 3 Preparation, Inspection and Operation
1. Pull the Slider to close the Cutter. 2. With the Cutter closed, carefully insert the instrument into the Biopsy Valve (see Figure 3.2). Keep as straight as possible.
Hold the Insertion Portion close to the Biopsy Valve.
Biopsy Valve
Figure 3.2
3. Advance the instrument until the Distal End of the Insertion Portion appears within the endoscopic field of view.
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