GK0351 EndoTherapy Instructions Grasping Forceps July 2016

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

16 17 19

Reprocessing... 27

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

Chapter 5 5.1 5.2

Preparation, Inspection and Operation... 15

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

Chapter 4 4.1 4.2 4.3 4.4 4.5

2 3 3 3 4 4 4

27 30 32 36 37

Storage ... 40

Inspection Before Storage ... Storage ...

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40 41

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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 70C –40C

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-6L/U-1 These instruments have been designed to be used with an Olympus endoscope to grasp tissue within the digestive tract and retrieve foreign bodies or tissue specimens from the digestive tract and respiratory organs.

 FG-7L/U-1, FG-8L/U-1, FG-9L/U-1, FG-42L-1, FG-47L-1, FG-48L-1, FG-49L-1, FG-50L-1 These instruments have been designed to be used with an Olympus endoscope to grasp tissue within the digestive tract and retrieve foreign bodies or tissue specimens from the digestive tract.

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GRASPING FORCEPS

Important Information - Please Read Before 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.

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.

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Important Information - Please Read Before Use

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.

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. 4

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

Lot Number (five digits) – Identification Number (four digits) Ring The forceps can be individually recognized by an The color of the Ring Identification Number. indicates the minimum instrument channel Reprocessing Port diameter required for Attach a syringe here to the endoscope to be Handle flush reprocessing compatible. chemicals, water and air Slider through the Insertion Portion Push the Slider to when reprocessing. open the Grasping Jaws. Pull to close. Model Reference Label A green reference Indicates the label indicates that product number. the instrument is autoclavable. Forceps Cap Prevents damage to the Grasping Jaws during transportation.

Grasping Jaws Used to grasp foreign body or tissue.

Insertion Portion/ Working Length Made from a metallic coil covered by an Outer Sheath.

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Outer Sheath Works as the channel through which reprocessing chemicals, water or air is flushed to the distal end of the Insertion Portion when reprocessing. When used in combination with electrosurgical accessories, the outer sheath isolates high-frequency current.

GRASPING FORCEPS

Chapter 2 Instrument Nomenclature and Specifications

Distal End

FG-6L/U-1, FG-7L/U-1

2.2

FG-8L/U-1, FG-9L/U-1, FG-48L-1, FG-50L-1

FG-42L-1, FG-47L-1, FG-49L-1

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 – 40C (50 – 104F)

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-6L-1

Shape of the

FG-6U-1

Alligator Jaws

Grasping Jaws

Maximum Insertion

ø 2.65

Portion Diameter (mm) Working Length

1650

(mm) Opening Width

2300 7.5

(mm) Compatible

Model and

Working

Working

Olympus

Length

Length less

Length less

Endoscopes

than 1200 mm;

than 1850 mm;

(All of these

EF, GIF, OGF,

EF, GIF, OGF,

parameters

GF, GTF, CF

GF, GTF, JF,

should be met.)

(Exclude I-,

TJF, SIF

L-length), OSF,

(SIF-10 only),

BF

CF, PCF, OSF, BF

Channel

ø 2.8, ø 3.2

ø 2.8, ø 3.2

Inner

(Yellow);

(Yellow);

Diameter

ø 3.7, ø 6

ø 3.7, ø 4.2,

(mm)

(Orange)

ø 6 (Orange);

(Color Code) Other

ø 5.5 (Pink) Can be used with electrosurgical accessories.

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GRASPING FORCEPS

Chapter 2 Instrument Nomenclature and Specifications

Model

FG-7L-1

Shape of the

FG-7U-1

Alligator Jaws

Grasping Jaws

Maximum Insertion

ø 3.4

Portion Diameter (mm) Working Length

1650

(mm) Opening Width

2300 11.3

(mm) Compatible

Model and

Working

Working

Olympus

Length

Length less

Length less

Endoscopes

than 1200 mm;

than 1850 mm;

(All of these

GIF

GIF, TJF, CF

parameters

Channel

ø 3.7, ø 6

ø 3.7, ø 4.2,

should be met.)

Inner

(Orange)

ø 6 (Orange);

Diameter

ø 5.5 (Pink)

(mm) (Color Code) Other

Can be used with electrosurgical accessories.

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Chapter 2 Instrument Nomenclature and Specifications

Model

FG-8L-1

Shape of the

FG-8U-1

Rat Tooth

Grasping Jaws

Maximum Insertion

ø 2.65

Portion Diameter (mm) Working Length

1650

(mm) Opening Width

2300 4.7

(mm) Compatible

Model and

Working

Working

Olympus

Length

Length less

Length less

Endoscopes

than 1200 mm;

than 1850 mm;

(All of these

EF, GIF, OGF,

EF, GIF, OGF,

parameters

GTF, GF, CF

GTF, GF, JF,

should be met.)

(Exclude I-,

TJF, SIF

L-length), OSF

(SIF-10 only), CF, PCF, OSF

Channel

ø 2.8, ø 3.2

ø 2.8, ø 3.2

Inner

(Yellow);

(Yellow);

Diameter

ø 3.7, ø 4.2,

ø 3.7, ø 4.2,

(mm)

ø 6 (Orange)

ø 6 (Orange);

(Color Code) Other

ø 5.5 (Pink) Can be used with electrosurgical accessories.

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GRASPING FORCEPS

Chapter 2 Instrument Nomenclature and Specifications

Model

FG-9L-1

Shape of the

FG-9U-1

Rat Tooth

Grasping Jaws

Maximum Insertion

ø 3.4

Portion Diameter (mm) Working Length

1650

(mm) Opening Width

2300 8.3

(mm) Compatible

Model and

Working

Working

Olympus

Length

Length less

Length less

Endoscopes

than 1200 mm;

than 1850 mm;

(All of these

GIF

GIF, TJF, CF

parameters

Channel

ø 3.7, ø 6

ø 3.7, ø 4.2,

should be met.)

Inner

(Orange)

ø 6 (Orange);

Diameter

ø 5.5 (Pink)

(mm) (Color Code) Other

Can be used with electrosurgical accessories.

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Chapter 2 Instrument Nomenclature and Specifications

Model

FG-42L-1

FG-47L-1

Shape of the

Rat Tooth with

Grasping Jaws

Alligator Jaws

Maximum Insertion

ø 2.65

Portion Diameter (mm) Working Length (mm) Opening Width (mm)

1650

1650

11.3

14.9

Compatible

Model and

Working Length less than

Olympus

Length

1200 mm;

Endoscopes

EF, GIF, OGF, CF (Exclude I-,

(All of these

L-length), OSF

parameters

Channel

should be met.)

Inner Diameter (mm)

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

(Color Code) Other

Direction of View: 0– 30 (Forward viewing and Forward-oblique viewing) only.

Other

Can be used with electrosurgical accessories.

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GRASPING FORCEPS

Chapter 2 Instrument Nomenclature and Specifications

Model

FG-48L-1

Shape of the

FG-49L-1 Rat Tooth with

Rat Tooth

Grasping Jaws

Alligator Jaws

Maximum Insertion

ø 2.65

Portion Diameter (mm) Working Length (mm) Opening Width (mm)

1650

1650

19.4

19.4

Compatible

Model and

Working Length less than

Olympus

Length

1200 mm;

Endoscopes

EF, GIF, OGF, CF (Exclude I-,

(All of these

L-length), OSF

parameters

Channel

should be met.)

Inner Diameter (mm)

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

(Color Code) Other

Direction of View: 0 – 30 (Forward viewing and Forward-oblique viewing) only.

Other

Can be used with electrosurgical accessories.

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Chapter 2 Instrument Nomenclature and Specifications

Model

FG-50L-1

Shape of the

Rat Tooth

Grasping Jaws

Maximum Insertion

ø 2.65

Portion Diameter (mm) Working Length

1650

(mm) Opening Width

15.5

(mm) Compatible

Model and

Working Length less than

Olympus

Length

1200 mm;

Endoscopes

EF, GIF, OGF, CF (Exclude I-,

(All of these

L-length), OSF

parameters

Channel

should be met.)

Inner Diameter (mm)

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

(Color Code) Other

Direction of View: 0– 30 (Forward viewing and Forward-oblique viewing) only.

Other

Can be used with electrosurgical accessories.

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 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 infection control risk, tissue irritation 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 or can cause tissue irritation.

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Chapter 3 Preparation, Inspection and Operation

3.1

•

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.

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.

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GRASPING FORCEPS

Chapter 3 Preparation, Inspection and Operation

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.

3.2

Inspection Wear the personal protective equipment as specified in the Table on page 31. 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.

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