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INSTRUCTIONS
GRASPING FORCEPS
FG-40ST-1 FG-53SX-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 8
Chapter 3 3.1 3.2 3.3
12 13 15
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 3 3 3 4 4
21 25 27 29 29
Storage ... 32
Inspection Before Storage ... Storage ...
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Contents
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GRASPING FORCEPS
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
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Important Information - Please Read Before Use
Important Information - Please Read Before Use Intended Use Do not use these instruments for any purpose other than their intended uses.
FG-40ST-1 This instrument has been designed to be used with an Olympus endoscope for grasping tissue or retrieving foreign bodies or tissue specimens from within the uterine cavity.
FG-53SX-1 This instrument has been designed to be used with an Olympus endoscope for retrieving foreign bodies or tissue specimens from within the digestive tract, upper airways, tracheobronchial tree, female reproductive and urinary organs.
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.
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GRASPING FORCEPS
Important Information - Please Read Before Use
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 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 or storage can present an infection control risk, cause equipment damage or reduce performance.
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Important Information - Please Read Before Use
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 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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GRASPING FORCEPS
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”.
Grasping Forceps
Instruction Manual
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Chapter 2 Instrument Nomenclature and Specifications
Chapter 2
2.1
Instrument Nomenclature and Specifications
Nomenclature and Functions FG-40ST-1
Lot Number (five digits) – Identification Number (four digits) The forceps can be individually recognized by an Identification Number. Model Reference Label Handle Indicates the product Rigid Section Portion number. Covers the tube at the junction of the Insertion Portion and the handle. When the rigid section is inserted into the T-Plug of an endoscope, the Handle can stand upright without being held.
Ring The color of the Ring indicates the minimum instrument channel diameter required for the endoscope to be compatible. Forceps Cap Prevents damage to the distal end of the Insertion Portion during transportation.
Slider Push the Slider to open the Grasping Jaws. Pull to close. A green model reference label indicates that the instrument is autoclavable. Grasping Jaws Insertion Portion /Working Length Made from a metallic coil.
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Used to grasp a foreign body or tissue.
GRASPING FORCEPS
Chapter 2 Instrument Nomenclature and Specifications
Distal End
FG-40ST-1
FG-53SX-1 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
Handle
Hexagonal Part
The color of the Ring indicates the minimum instrument channel diameter required for the endoscope to be compatible. Forceps Cap
Holding the Hexagonal Part and rotating the Insertion Portion clock-wise will rotate the Grasping Jaws clockwise.
Prevents damage to the distal end during transportation.
Model Reference Label Indicates the product number.
Grasping Jaws Used to grasp a foreign body or tissue.
Insertion Portion/Working Length Made from a metallic coil.
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Chapter 2 Instrument Nomenclature and Specifications
Distal End
FG-53SX-1 (Have a sharper tooth than FG-40ST-1)
2.2
Specifications The compatible Olympus endoscopes are listed in the Table on the following page. 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 to 40C (50 to 104F)
Relative Humidity
30 to 85%
Air Pressure
700 to 1060 hPa (0.71 to 1.08 kgf/cm2) (10.1 to 15.4 psia)
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Chapter 2 Instrument Nomenclature and Specifications
Specifications Model
FG-40ST-1
FG-53SX-1
Shape of the
Rat Tooth
Sharp Tooth
ø 1.85
ø 1.8
500
700
3.0
8.0
Grasping Jaws
Maximum Insertion Portion Diameter (mm) Working Length (mm) Opening Width (mm) Compatible
Model and
Olympus
Length
Endoscopes
Working length less than HYF-1T only
400 mm;
(All of these
CHF, ENF,
parameters
CYF, HYF
should be met.)
Channel Inner Diameter
ø 2.2 (Blue)
ø 2, ø 2.2
(mm)
(Blue)
(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
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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, pose an infection control risk, cause tissue irritation, punctures, hemorrhages or mucous membrane 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
•
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 with 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.
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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.
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Chapter 3 Preparation, Inspection and Operation
3.2
Inspection Wear the personal protective equipment as specified in the instructions on page 26. 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. Replace it with a spare.
Appearance Inspection If any of the following steps reveals irregularities, do not use the instrument; use a spare instead.
1. While operating the Slider to open and close the Grasping Jaws, confirm that there is no peeling or looseness at the connecting section.
2. Make sure that the Grasping Jaws close evenly and are properly aligned when the Slider is pulled.
3. Confirm that the Distal End of the instrument appears exactly as shown in the table in Section 2.2, “Specifications” and is not damaged.
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
Inspection of 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 3.1, bend the Insertion Portion into a radius of approximately 10 cm.
Open
Close
Approximately 10 cm
Figure 3.1
2. Operate the Slider and confirm that the Grasping Jaws open and close smoothly.
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Chapter 3 Preparation, Inspection and Operation
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. •
When using the 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 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 pose a risk of punctures, hemorrhages, or mucous membrane damage. It may also damage the endoscope and/or instrument.
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Chapter 3 Preparation, Inspection and Operation
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•
Do not angulate the endoscope’s Bending Section abruptly 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.
•
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.
GRASPING FORCEPS
Chapter 3 Preparation, Inspection and Operation
Insertion Into the Endoscope •
Do not force the instrument if resistance to insertion is encountered. Reduce the angulation of the endoscope until the instrument passes smoothly. Forcing the instrument could damage the instrument and/or endoscope. This could result in puncture, hemorrhage or mucous membrane damage.
•
When inserting the instrument into the endoscope, make sure to hold the Slider firmly. Otherwise, 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 advance or extend the instrument abruptly. This could result in punctures, hemorrhages or mucous membrane damage. It could also damage the endoscope or instrument.
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