EndoTherapy Grasping Forceps Instructions

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

17 18 21

Reprocessing... 29

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

29 33 35 36 37

Storage ... 40

Inspection Before Storage ... Storage ...

GRASPING FORCEPS

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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 instrument for any purpose other than their intended use.

 FG-4L-1, FG-14P-1, FG-38SX-1 This instrument has been designed to be used with Olympus endoscopes in retrieving foreign bodies or tissue specimens from within the digestive tract, upper airways, tracheobronchial tree, female reproductive and urinary organs.

 FG-25C-1, FG-26C-1, FG-32C/L-1 This instrument has been designed to be used with Olympus endoscopes in retrieving foreign bodies or tissue specimens from within the digestive tract and respiratory organs.

 FG-20P-1 This instrument has been designed to be used with Olympus endoscopes in retrieving foreign bodies from within the digestive tract, upper airways, tracheobronchial tree, female reproductive and urinary organs.

 FG-21L-1 This instrument has been designed to be used with Olympus endoscopes in retrieving foreign bodies from within the digestive tract. 2

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 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.

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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 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.

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 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. 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. Handle Model Reference Label Indicate the product number.

Insertion Portion /Working Length Made from a metallic coil.

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GRASPING FORCEPS

Forceps Cap Prevents damage to the distal end of during transportation. (Exclude FG-4L-1)

Grasping Jaws Used to grasp foreign body or tissue.

Chapter 2 Instrument Nomenclature and Specifications

Distal End

FG-4L-1, FG-25C-1

Rubber (Non latex) Prevents a grasped object from slipping.

FG-14P-1, FG-26C-1

Sheet Prevents the rubber chips from fastening when the instrument is transported.

FG-20P-1, FG-21L-1

2.2

FG-32C/L-1, FG-38SX-1 (Have a sharper tooth than FG-14P-1, FG-26C-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. GRASPING FORCEPS

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Chapter 2 Instrument Nomenclature and Specifications

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)

Specifications Model

FG-14P-1

Shape of the

Rat Tooth

Grasping Jaws

Maximum Insertion Portion

ø 1.85

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

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1900 3.0

Chapter 2 Instrument Nomenclature and Specifications

Compatible

Model and

Working length

Olympus

Length

less than 1450 mm;

Endoscopes

EF, GIF, OGF, GF, GTF, JF, TJF,

(All of these

CHF, CF (Exclude L-length),

parameters

PCF (Exclude L-length), OSF, BF,

should be met.)

ENF, CYF, HYF Channel

ø 2, ø 2.2 (Blue);

Inner

ø 2.6 (Green);

Diameter

ø 2.8 (Green or Yellow);

(mm)

ø 3.2 (Yellow);

(Color Code)

ø 3.7, ø 4.2, ø 6 (Orange); ø 5.5 (Pink)

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Chapter 2 Instrument Nomenclature and Specifications

Model

FG-26C-1

Shape of the

Rat Tooth

Grasping Jaws

Maximum Insertion

ø 2.2

Portion Diameter (mm) Working Length

1050

(mm) Opening Width

3.5

(mm) Compatible

Model and

Working length

Olympus

Length

less than 600 mm;

Endoscopes

CHF, OSF, BF

(All of these

Channel

ø 2.6 (Green);

parameters

Inner

ø 2.8 (Green or Yellow)

should be met.)

Diameter (mm) (Color Code) Other

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Exclude BF-XT20/30

Chapter 2 Instrument Nomenclature and Specifications

Model

FG-20P-1

FG-21L-1

Shape of the

Rubber Tips (Non latex)

Grasping Jaws

Maximum Insertion Portion

ø 1.85

ø 2.4

1900

1650

4.8

7.3

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

Model and

Working length

Working length

Olympus

Length

less than

less than

Endoscopes

1450 mm;

1200 mm;

(All of these

EF, GIF, OGF,

EF, GIF, OGF,

parameters

GF, GTF, JF,

GF, GTF, CF

should be met.)

TJF, CHF, CF

(Exclude I-,

(Exclude

L-length), OSF

L-length), PCF (Exclude L-length), OSF, BF, ENF, CYF, HYF Channel

ø 2,ø 2.2

ø 2.8, ø 3.2

Inner

(Blue);

(Yellow);

Diameter

ø 2.6 (Green);

ø 3.7, ø 4.2,

(mm)

ø 2.8 (Green or

ø 6 (Orange)

(Color Code)

Yellow); ø 3.2 (Yellow); ø 3.7, ø 4.2, ø 6 (Orange); ø 5.5 (Pink)

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Chapter 2 Instrument Nomenclature and Specifications

Model

FG-32C-1

Shape of the

FG-32L-1

Sharp Tooth

Grasping Jaws

Maximum Insertion

ø 2.6

Portion Diameter (mm) Working Length

1050

(mm) Opening Width

1650 4.7

(mm) Compatible

Model and

Working length

Working length

Olympus

Length

less than

less than

Endoscopes

600 mm;

1200 mm;

(All of these

OSF, BF

EF, GIF, OGF,

parameters

GF, GTF, CF

should be met.)

(Exclude I-, L-length), OSF, BF Channel

ø 2.8,ø 3.2

ø 2.8, ø 3.2

Inner

(Yellow)

(Yellow);

Diameter

ø 3.7, ø 4.2,

(mm)

ø 6 (Orange)

(Color Code)

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Chapter 2 Instrument Nomenclature and Specifications

Model

FG-4L-1

FG-38SX-1

Shape of the

W Shape

Sharp Tooth

Grasping Jaws

Maximum Insertion

ø 1.85

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

1650

700

13.0

5.0

Compatible

Model and

Working length

Working length

Olympus

Length

less than

less than

Endoscopes

1200 mm;

400 mm;

(All of these

GIF, OGF,

CHF, ENF,

parameters

CHF, CF

CYF, HYF

should be met.)

(Exclude I-, L-length), OSF, ENF, CYF, HYF Channel

ø 2, ø 2.2

ø 2, ø 2.2

Inner

(Blue);

(Blue);

Diameter

ø 2.6 (Green);

ø 2.6 (Green)

(mm)

ø 2.8, ø 3.2

(Color Code)

(Yellow); ø 3.7, ø 6 (Orange)

Other

Direction of View: 0 (Forward

–

viewing) only.

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Chapter 2 Instrument Nomenclature and Specifications

Model

FG-25C-1

Shape of the

W Shape

Grasping Jaws

Maximum Insertion

ø 2.2

Portion Diameter (mm) Working Length

1050

(mm) Opening Width

13.0

(mm) Compatible

Model and

Working length less than

Olympus

Length

600 mm;

Endoscopes

CHF, OSF, BF

(All of these

Channel

ø 2.6 (Green); ø 2.8 (Green or

parameters

Inner

Yellow); ø 3.2 (Yellow);

should be met.)

Diameter (mm) (Color Code) Other

Direction of View: 0 (Forward viewing) 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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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 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.

GRASPING FORCEPS

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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