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INSTRUCTIONS
GRASPING FORCEPS
FG-45L/U-1 FG-46L/U-1
AUTOCLAVABLE USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Contents
Contents Symbols...
1
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
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 2 3 3 3 4
21 25 27 30 32
Storage ... 35
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 This instrument has been designed to be used with Olympus endoscopes to retrieve foreign bodies or tissue specimens 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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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.
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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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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”.
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
Lot Number (five digits) – Identification Number (four digits) The forceps can be individually recognized by an Identification Number. Reprocessing Port Attach a syringe here to flush reprocessing chemicals, water and air through the Insertion Portion when reprocessing.
Handle
Model Reference Label Indicate the product number.
Ring The color of the Ring indicates the minimum instrument channel diameter required for the endoscope to be compatible. Slider Push the Slider to open the Grasping Jaws. Pull to close. A green reference label indicates that the instrument is autoclavable. Grasping Jaws Used to grasp foreign body or resected tissue.
Outer Sheath
Insertion Portion/Working Length Made from a metallic coil covered by an Outer Sheath.
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Works as the channel through which reprocessing chemicals, water or air is flushed to the distal end of the Insertion Portion when reprocessing.
Chapter 2 Instrument Nomenclature and Specifications
Distal End
FG-45L/U-1
2.2
FG-46L/U-1
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 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-45L-1
Shape of the
FG-45U-1
Tripod Type
Grasping Jaws
Maximum Insertion
ø 2.6
Portion Diameter (mm) Working Length
1650
(mm) Opening Width
2300 ø 20
(mm) Compatible
Model and
Olympus
Length
Working length
Working length
less than
less than
Endoscopes
1200 mm;
1850 mm;
(All of these
GIF, OGF, CF
GIF, OGF, SIF
parameters
(Exclude I-,
(SIF-10 only),
L-length), OSF
CF, PCF, OSF
ø 2.8, ø 3.2
ø 2.8, ø 3.2
should be met.) Channel Inner Diameter (mm) (Color Code) Other
(Yellow);
(Yellow);
ø 3.7, ø 6
ø 3.7, ø 4.2,
(Orange)
ø 6 (Orange)
Direction of View: 0 (Forward viewing type) only
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Chapter 2 Instrument Nomenclature and Specifications
Model
FG-46L-1
Shape of the
FG-46U-1
Pentapod Type
Grasping Jaws
Maximum Insertion
ø 2.6
Portion Diameter (mm) Working Length
1650
(mm) Opening Width
2300 ø 20
(mm) Compatible
Model and
Olympus
Length
Working length
Working length
less than
less than
Endoscopes
1200 mm;
1850 mm;
(All of these
GIF, OGF, CF
GIF, OGF, SIF
parameters
(Exclude I-,
(SIF-10 only),
L-length), OSF
CF, PCF, OSF
ø 2.8, ø 3.2
ø 2.8, ø 3.2
should be met.) Channel Inner Diameter (mm) (Color Code) Other
(Yellow);
(Yellow);
ø 3.7, ø 6
ø 3.7, ø 4.2,
(Orange)
ø 6 (Orange)
Direction of View: 0 (Forward viewing type) only
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 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.
•
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.
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Chapter 3 Preparation, Inspection and Operation
•
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 protective equipment as specified in the Table 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 has been compromised. Use a spare instead.
Appearance Inspection If any of 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. Confirm that the distal end of the instrument appears exactly as shown in the Tables in Section 2.2, “Specifications” on page 7 and is not damaged.
3. Gently run your fingertips over the entire length of the Insertion Portion to check for any crushed areas, excessive bends, etc.
4. Inspect the entire length of the Outer Sheath for broken areas.
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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, 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 Grasping Jaws open and close smoothly.
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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 force the distal end of the Insertion Portion against body cavity tissue. 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. 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.
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Chapter 3 Preparation, Inspection and Operation
Insertion Into the Endoscope •
Do not insert the instrument while the endoscope’s insertion portion is angulated. The distal end of the Insertion Portion may extend from the endoscope tip 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, 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 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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