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INSTRUCTIONS
ROTATABLE GRASPING FORCEPS
FG-44NR-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...
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Checking the Package Contents ...
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Chapter 2 2.1 2.2
Instrument Nomenclature and Specifications ...
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Nomenclature and Functions... Specifications...
6 7
Chapter 3 3.1 3.2 3.3
Preparation, Inspection and Operation ...
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Preparation ... Inspection ... Operation ...
11 12 15
Chapter 4 4.1 4.2 4.3 4.4 4.5
Reprocessing... 22
General Policy ... Required Reprocessing Equipment ... Cleaning... Lubrication ... Sterilization ...
Chapter 5 5.1 5.2
2 2 2 3 3 3 4
22 26 28 30 31
Storage ... 34
Inspection Before Storage ... Storage ...
ROTATABLE GRASPING FORCEPS FG-44NR-1
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Contents
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ROTATABLE GRASPING FORCEPS FG-44NR-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
Not Made with Natural Rubber Latex 70C -40C
Temperature limitation
ROTATABLE GRASPING FORCEPS FG-44NR-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 Olympus endoscopes in retrieving drainage tube or foreign bodies from the digestive tract. 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 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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ROTATABLE GRASPING FORCEPS FG-44NR-1
Important Information - Please Read Before Use
Instrument Compatibility Refer to the tables in Section 2.2, “Specifications” on page 7 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.
ROTATABLE GRASPING FORCEPS FG-44NR-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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ROTATABLE GRASPING FORCEPS FG-44NR-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 damages. 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”.
Rotatable Grasping Forceps
Instruction Manual
ROTATABLE GRASPING FORCEPS FG-44NR-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 forceps can be individually recognized by an Identification Number. Slider Push the Slider to open the Grasping Jaws. Pull to close. A green reference label indicates that the instrument is autoclavable.
Ring The color of the Ring indicates the minimum instrument channel diameter required for the endoscope to be compatible.
Handle
Hexagonal Part Holding the Hexagonal Part and rotating the Insertion Portion clockwise will rotate the Grasping Jaws clockwise.
Forceps Cap Prevents damage to the distal end during transportation.
Model Reference Label Indicate the product number.
Grasping Jaws Used to grasp drainage tube or foreign body.
Insertion Portion/Working Length Made from a metallic coil. Distal End
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ROTATABLE GRASPING FORCEPS FG-44NR-1
Chapter 2 Instrument Nomenclature and Specifications
2.2
Specifications The compatible Olympus endoscopes are listed in the following table. 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, 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
FG-44NR-1
Shape of the
Rat Tooth with
Grasping Jaws
Alligator Jaws
Maximum Insertion Portion
ø 2.6
Diameter (mm) Working Length
1800
(mm) Opening Width
6.9
(mm) Compatible
Model and
Working length less than
Olympus
Length
1350 mm;
Endoscopes
EF, GIF, OGF, GF, GTF, JF, TJF,
(All of these
CF (Exclude L-length), PCF
parameters
(Exclude L-length), OSF
should be met.)
Channel Inner Diameter (mm)
ø 2.8, ø 3.2 (Yellow); ø 3.7, ø 4.2, ø 6 (Orange); ø 5.5 (Pink);
(Color Code)
Medical Devices
This device complies with the
Directive
requirements of Directive 93/42/EEC concerning medical devices. Classification: Class I
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Chapter 3 Preparation, Inspection and Operation
Chapter 3
Preparation, Inspection and Operation •
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. Should the slightest irregularity be suspected, do not use the instrument; contact Olympus. Damage or irregularity may compromise patient or user safety as well 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 cleaned and sterilized. This poses an infection control risk and can cause tissue irritation.
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Chapter 3 Preparation, Inspection and Operation
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•
Before use, confirm that the instrument is not corroded, dented or discolored; do not use it if any of these conditions are observed. If the instrument is damaged, part of it could fall off inside the patient, or it could become impossible to open or close.
•
If the instrument does not operate properly during the procedure, or if it becomes difficult to open or close the grasping jaws, stop the procedure immediately and withdraw the instrument into the endoscope’s channel. If this is not possible, carefully remove it together with the endoscope to avoid causing patient injury.
•
If a part of the instrument falls off inside the patient, use a spare instrument to retrieve it.
•
Do not coil the Insertion Portion in a diameter of less than 15 cm. This could damage the Insertion Portion.
•
Never use excessive force to open or close the Grasping Jaws. This could damage the instrument.
ROTATABLE GRASPING FORCEPS FG-44NR-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, etc.
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.
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Chapter 3 Preparation, Inspection and Operation
3.2
Inspection Wear the protective equipment as specified in the instructions on page 27. 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 has been compromised. Replace with a spare.
Appearance Inspection If any of following steps reveals irregularities, do not use the instrument; use a spare instead.
1. If the Insertion Portion’s coil is unevenly wound (see Figure 3.1), pull both ends of the uneven section away from each other as shown in Figure 3.2 until the coil is smooth.
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Chapter 3 Preparation, Inspection and Operation
Uneven Insertion Portion coil
Figure 3.1
How to remove unevenness from the Insertion Portion’s coil
Figure 3.2
2. While operating the Slider to open and close the Grasping Jaws, confirm that there is no peeling or looseness at the connecting section.
3. Make sure the Grasping Jaws close evenly when the Slider is pulled.
4. Gently run your fingertips over the entire length of the Insertion Portion to check for any crushed areas, excessive bends, etc.
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Chapter 3 Preparation, Inspection and Operation
5. Confirm that the distal end of the instrument appears exactly as shown in the table in Section 2.2, “Specifications” on page 7 and is not damaged.
Inspection of the Operation If the Grasping Jaws do not operate smoothly and as intended, do not use the instrument; use a spare instead.
1. Holding the instrument as shown in Figure 3.3, form a loop in the Insertion Portion approximately 20 cm in diameter.
Open
Close
Approximately 20 cm
Figure 3.3
2. Operate the Slider and confirm that the Grasping Jaws open and close smoothly. The Grasping Jaws will not operate smoothly if the coil is unevenly wound, as shown in Figure 3.1.
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Chapter 3 Preparation, Inspection and Operation
3.3
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. •
When using this instrument, always wear appropriate personal protective equipment. Otherwise, blood, mucous and other potentially infectious 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, etc.
•
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 a risk of punctures, hemorrhages or mucous membrane damage. It may also damage the endoscope or instrument.
•
Do not angulate the Insertion Portion of the endoscope while the distal end of the Insertion Portion is extended from the distal end of the endoscope. This could result in punctures, hemorrhages or mucous membrane damage.
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Chapter 3 Preparation, Inspection and Operation
•
Do not grasp objects or tissue with excessive force. The grasping jaws may become damaged and could fall off inside the patient. Continuously monitor the endoscopic image during the procedure, and make sure that the instrument appears and operates properly. If a part of the instrument falls off inside the patient, stop using it immediately. Use a spare instrument to retrieve the part. When using the instrument with a two channel endoscope, never use electrosurgical accessories at the same time. This could result in burns to the patient, operator or assistant.
Insertion Into the Endoscope
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•
When inserting the instrument into the endoscope, make sure to hold the Slider firmly. If the Slider is not held still, the Grasping Jaws may open and extend from the endoscope tip abruptly. This could result in punctures, hemorrhages or mucous membrane damage. It could also damage the endoscope or instrument.
•
Do not force the instrument if resistance to insertion is encountered. Reduce the angulation or lower the Forceps Elevator of the endoscope until the instrument passes smoothly. Forcing the instrument could result in punctures, hemorrhages or mucous membrane damage. It could also damage the endoscope and/or instrument.
ROTATABLE GRASPING FORCEPS FG-44NR-1
Chapter 3 Preparation, Inspection and Operation
•
Do not advance or extend the instrument abruptly. This could result in punctures, hemorrhages or mucous membrane damage. It could also damage the endoscope 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 could be damaged.
Combined With non-GF, non-GTF, non-JF or non-TJF Endoscopes 1. Pull the Slider to close the Grasping Jaws. 2. With the Grasping Jaws closed, carefully insert the instrument into the Biopsy Valve (see Figure 3.4). Keep as straight as possible. Hold the Insertion Portion close to the Biopsy Valve.
Biopsy Valve
Figure 3.4
3. Advance the instrument until the distal end of the Insertion Portion appears within the endoscopic field of view.
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