EndoTherapy Instructions Grasping Forceps

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 ... Warnings...

2 2 2 3 3 3 4 4

Chapter 1 1.1

Checking the Package Contents...

6

Checking the Package Contents ...

6

Chapter 2 2.1 2.2

Instrument Nomenclature and Specifications ...

7

Nomenclature and Functions... Specifications...

7 8

Chapter 3 3.1 3.2 3.3

Preparation ... Inspection ... Operation ...

Chapter 4 4.1

12 13 16

Emergency Treatment... 24

Emergency Treatment ...

Chapter 5 5.1 5.2 5.3 5.4 5.5

Preparation, Inspection and Operation ... 11

24

Reprocessing... 28

General Policy ... Required Reprocessing Equipment ... Cleaning... Lubrication ... Sterilization ...

GRASPING FORCEPS

28 31 33 37 38

i

Contents

Chapter 6 6.1 6.2

ii

Storage ... 41

Inspection Before Storage ... Storage ...

GRASPING FORCEPS

41 42

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

Authorised representative in the European Community Lot Number Keep away from sunlight

Keep dry

Not Made with Natural Rubber Latex 70C -40C

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, calculus 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.

2

GRASPING FORCEPS

Important Information - Please Read Before Use

Instrument Compatibility Refer to the Tables in Section 2.2, “Specifications” on page 8 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 5, “Reprocessing”. After using this instrument, reprocess and store it according to the instructions in Chapter 5, “Reprocessing” and Chapter 6, “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.

Warnings Follow the warnings given below when handling the instrument. This information is to be supplemented by the warnings and cautions described in each section. •

4

Before use, thoroughly review the method of use for this instrument and lithotriptor BML-110A-1 in accordance with the instruction manuals. Using the instrument without learning such information could cause patient injury.

GRASPING FORCEPS

Important Information - Please Read Before Use

•

Do not use this instrument for a calculus that is assumed impossible to be retrieved by this instrument in preoperative diagnosis, intraoperative contrast enhancing or after papillotomy/ papillary dilation. Do not use this instrument when it is inevitable to grasp many calculus at a time. The basket with calculus engaged may not be removed from the body.

•

Use this instrument by having the settings to switch to open surgery and the hospitalization plan ready in case this instrument with calculus engaged may not be removed from the body, or in case the calculus cannot be crushed even the lithotriptor BML-110A-1 is used in combination.

•

When the basket may not be removed from the body, refer to Section4.1, “Emergency Treatment”, and perform open surgery etc. or possible treatments such as crush the calculus by using lithotriptor BML-110A-1 in combination, as appropriate.

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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 5, “Reprocessing”.

Grasping Forceps

Instruction Manual

6

GRASPING FORCEPS

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2

2.1

Instrument Nomenclature and Specifications

Nomenclature and Functions Grip Push the Grip to open the Grasping Basket. Pull to close.

Injection Port Attach a syringe here to inject contrast medium. Attach a syringe here to flush reprocessing chemicals, water and air through the Insertion Portion when reprocessing. Model Reference This indicates the product number. A green reference label indicates that the instrument is autoclavable.

Handle

Protection Cap Lot Number

This cap prevents damage to the distal end during transportation. Grasping Basket This Basket is used to grasp a foreign body, calculus or resected tissue. Tube

Insertion Portion /Working Length

Works as the channel through which contrast medium is injected, during use. It also works as the channel through which reprocessing chemicals, water or air is flushed to the distal end when reprocessing.

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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.

•

Operation of Mechanical Lithotriptor BML-110A-1 is based on the assumption that open surgery is possible as an emergency measure. If the Grasping Forceps are used in combination with the BML-110A-1, there is the possibility of damages shown in Chapter 4, “Emergency Treatment” may occur. Use the BML-110A-1 by considering that it may lead to damaging the Grasping Forceps and that open surgery may have to take place.

Operating Environment Ambient Temperature

10 to 40C (50 to 104F)

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-22Q-1

FG-23Q-1

Shape of the Grasping Basket

Maximum Insertion Portion

ø 2.5

in Diameter (mm) Working Length

1950

(mm) Opening Width

22

(mm) Type of the

Hard

Basket Wire Compatible

Length and

Olympus

Model

Endoscopes

Soft

Working length less than 1400 mm; EF, GIF, GF, GTF, OGF, JF, TJF,

(All of these

CF (Exclude L-length),

parameters

PCF (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)

(Color Code) Compatible Olympus Lithotriptor for

BML-110A-1

Emergency Use

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Chapter 2 Instrument Nomenclature and Specifications

Model

FG-301Q

Shape of the Grasping Basket

Maximum Insertion Portion

ø 2.5

in Diameter (mm) Working Length

1950

(mm) Opening Width

20

(mm) Type of the

Soft

Basket Wire Compatible

Length and

Olympus

Model

Endoscopes

Working length less than 1400 mm; EF, GIF, GF, GTF, OGF, JF, TJF,

(All of these

CF (Exclude L-length),

parameters

PCF (Exclude L-length), OSF

should ne met.)

Channel Inner Diameter (mm)

ø 2.8, ø 3.2 (Yellow); ø 3.7, ø 4.2, ø 6 (Orange)

(Color Code) Compatible Olympus

BML-110A-1

Lithotriptor for Emergency Use

Medical Devices

This device complies with the

Directive

requirements of Directive 93/42/EEC concerning medical devices. Classification: Class I

10

GRASPING FORCEPS

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 5, “Reprocessing”. Do not use an instrument that has not been cleaned 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 Grasping Basket. 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 5.2, “Required Reprocessing Equipment” for immediate reprocessing after use.

Sterile Syringe and Contrast Medium for Inspection Prepare a sterile syringe and contrast medium for inspection.

Equipment to be Used in Emergency In case this instrument damages, prepare an Olympus lithotriptor BML-110A-1 and sharp pliers to cut the insertion portion of this instrument.

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GRASPING FORCEPS

Chapter 3 Preparation, Inspection and Operation

3.2

Inspection Wear the protective equipment as specified in the instructions on page 32. Before each case, always inspect the instrument according to the following procedures. If an abnormality in the instrument is detected, use a spare instrument. Inspect 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 compromissed. 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 Grip to open and close the Grasping Basket, confirm that there is no peeling or looseness at the connecting section.

2. Open the Grasping Basket. Make sure that there are no unraveled wires, disconnections, sharp protrusions, sharp edges or any other apparent abnormalities. Confirm that the distal end of the instrument appears exactly as shown in the Table in Section 2.2, “Specifications” on page 8 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.

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Chapter 3 Preparation, Inspection and Operation

Inspection of Operation Check that no abnormality is detected in the action of the handle. If there is any abnormality, the calculus may not be retrieved and/or the basket with calculus engaged may not be removed from the body. If the Grasping Basket 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 Grip and confirm that the Grasping Basket opens and closes smoothly.

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GRASPING FORCEPS

Chapter 3 Preparation, Inspection and Operation

Inspecting Irrigation Be sure to use a contrast medium intended for patient use when inspecting irrigation. If other fluids are used, the fluids may remain. This could pose an infection control risk or tissue irritation. Do not use the instrument if the contrast medium cannot be injected or if it leaks from any areas other than the distal end. In this case, use a spare instead.

1. Open the Grasping Basket and inject a contrast medium into the instrument’s Injection Port using a sterile syringe. Confirm that the contrast medium comes out of the distal end (see Figure 3.2).

Syringe Injection Port

Figure 3.2

2. Make sure that the contrast medium does not leak from any areas other than the distal end of the instrument.

3. Connect a sterile syringe to the instrument’s Injection Port. Inject air into the Insertion Portion to discharge the contrast medium.

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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.

16

•

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.

•

Do not insert the instrument into the endoscope unless having a clear endoscopic field of view. If not being able to see the distal end of the Insertion Portion in the endoscopic field of view or in x-ray images, do not use it. This could pose 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 or operate the Forceps Elevator 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.

GRASPING FORCEPS

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.

•

If the grasping basket cannot be withdrawn from the bile duct or pancreatic duct while holding a calculus, do not pull it with excessive force. This could damage the operation wire and/or the basket wires such that a part of the instrument could fall off inside the patient. If a calculus cannot be removed from the grasping basket while the calculus is in the bile duct, use Olympus mechanical lithotriptor BML-110A-1 to crush the calculus and withdraw the grasping forceps. For further details, refer to Section 4.1, “Emergency Treatment”.

•

Use of the BML-110A-1 could damage the grasping forceps and require open surgery as an emergency measure. It may be difficult to remove calculus from FG-301Q when compared to FG-22Q-1 and FG-23Q-1 due to the construction of the basket. Select and use a Grasping Forceps by comprehending the characteristics of the Grasping Forceps.

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