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...

Chapter 1 1.1

Checking the Package Contents...

6

Checking the Package Contents ...

6

Chapter 2 2.1 2.2

Instrument Nomenclature and Specifications ...

8

Nomenclature and Functions... Specifications...

8 11

Chapter 3 3.1 3.2 3.3

16 17 23

Reprocessing... 31

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 5

31 34 36 40 41

Storage ... 44

Inspection Before Storage ... Storage ...

GRASPING FORCEPS

44 45

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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 use.

 FG-16L/U-1 This instrument has been designed to be used with Olympus endoscopes to retrieve foreign bodies, calculi or resected tissue from within the digestive tract and respiratory organs.

 FG-17K-1/FG-18Q-1 This instrument has been designed to be used with Olympus endoscopes to retrieve foreign bodies, calculi or resected tissue from within the digestive tract, respiratory organs, female reproductive organs and urinary organs.

 FG-19SX-1 This instrument has been designed to be used with Olympus endoscopes to retrieve foreign bodies, calculi or resected tissue from within the digestive tract.

 FG-24SX-1 This instrument has been designed to be used with Olympus endoscopes to retrieve foreign bodies, calculi or resected tissue from within the digestive tract and urinary organs.

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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 Tables in Section 2.2, “Specifications” on page 11 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 and FG Handle were not sterilized before shipment. Before using this instrument and FG Handle for the first time, reprocess them according to the instructions in Chapter 4, “Reprocessing”. After using this instrument and FG Handle, reprocess and store them 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 and FG Handle contain 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

Important Information - Please Read Before Use

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. •

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.

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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 or FG Handle is damaged, a component is missing or you have any questions, do not use the instrument or FG Handle; immediately contact Olympus. This instrument and FG Handle were not sterilized before shipment. Before using this instrument and FG Handle for the first time, reprocess them according to the instructions in Chapter 4, “Reprocessing”.

 A set

Grasping Forceps

Instruction Manual

FG Handle

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GRASPING FORCEPS

Chapter 1 Checking the Package Contents

 B set Grasping Forceps (1 piece) Instruction Manual

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Chapter 2 Instrument Nomenclature and Specifications

Chapter 2

Instrument Nomenclature and Specifications

This instrument must be used in combination with the FG Handle.

2.1

Nomenclature and Functions  Grasping Forceps 5. Operating Pipe 1. Wings 4. Stopper 2. Injection Port Handle

3. Model Reference Lot Number

6. Protection Cap

7. Grasping Basket Insertion Portion /Working Length 8. Tube

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GRASPING FORCEPS

Chapter 2 Instrument Nomenclature and Specifications

 FG Handle

9. Red Mark 11. Slider Lot Number 12. Locking Knob 13. Clamping Ring 10. Groove

1. Wings When the instrument is inserted into the Groove of the FG Handle, the Wings prevent the instrument from rotating with respect to the FG Handle. 2. 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. 3. Model Reference Indicates the product number. A green reference label indicates the instrument is autoclavable. 4. Stopper Fixed into the Clamping Ring of the FG Handle. 5. Operating Pipe Fixed into the Slider of the FG Handle. 6. Protection Cap Prevents damage to the distal end during transportation. 7. Grasping Basket Used to grasp foreign body, calculi or resected tissue. GRASPING FORCEPS

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Chapter 2 Instrument Nomenclature and Specifications

8. Tube 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. 9. Red Mark When this mark is visible in the notch of the Clamping Ring, the Stopper of the instrument can be connected or disconnected. 10. Groove Holds the Wings of the instrument in place. 11. Slider Push the Slider to open the Grasping Basket. Pull to close. 12. Locking Knob The Operating Pipe of the instrument can be fixed or released by rotating the Locking Knob. 13. Clamping Ring Holds or releases the Stopper of the instrument when rotated. A green Clamping Ring indicates that the FG Handle is autoclavable.

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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 and FG Handle may also be compatible for use in combination with this instrument and FG Handle. For further details, contact Olympus. Use this instrument and FG Handle 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 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-16L-1

FG-16U-1

Shape of the Grasping Basket

Maximum Insertion

ø 2.5

Portion Diameter (mm) Working Length

1650

(mm) Opening Width

35

(mm) Compatible

Length and

Working

Working

Olympus

Model

length less

length less

Endoscopes

than

than

(All of these

1200 mm;

1850 mm;

parameters

EF, GIF, GF,

EF, GIF, GF,

should be met.)

GTF, OGF, CF

GTF, OGF, JF,

(Exclude I-,

TJF, SIF (Only

Channel Inner Diameter (mm) (Color Code) Compatible FG Handle

12

2300

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L-length),

SIF-10), CF,

OSF, BF

PCF, OSF, BF

ø 2.8, ø 3.2

ø 2.8, ø 3.2

(Yellow);

(Yellow);

ø 3.7, ø 6

ø 3.7, ø 4.2,

(Orange)

ø 6 (Orange)

FG Handle: MA-479

Chapter 2 Instrument Nomenclature and Specifications

Model

FG-17K-1

FG-18Q-1

Shape of the Grasping Basket

Maximum Insertion

ø 1.8

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

Length and

Olympus

Model

1550

1950

32

22

Working

length less

Working

Endoscopes

length less

than

(All of these

than

1400 mm;

parameters

1100 mm;

EF, GIF, GF,

should be met.)

EF, GIF, GF,

GTF, OGF, JF,

GTF, OGF, CF

TJF, CF

(Exclude I-,

(Exclude

L-length),

L-length),

OSF, ENF

PCF, OSF,

CYF, HYF, BF

ENF, CYF, HYF, BF

Channel Inner Diameter

ø 2, ø 2.2 ø 2 (Blue);

(Blue);

ø 2.6 (Green);

ø 2.6 (Green);

(mm)

ø 2.8, ø 3,

ø 2.8, ø 3,

(Color Code)

ø 3.2 (Green,

ø 3.2 (Green,

Yellow); ø 3.7,

Yellow); ø 3.7,

ø 6 (Orange)

ø 4.2, ø 6 (Orange)

Compatible FG Handle

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FG Handle: MA-479

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Chapter 2 Instrument Nomenclature and Specifications

Model

FG-19SX-1

FG-24SX-1

ø 2.5

ø 1.8

Shape of the Grasping Basket

Maximum Insertion Portion Diameter (mm) Working Length

700

(mm) Opening Width

22

(mm) Compatible

Length and

Working

Working

Olympus

Model

length less

length less

Endoscopes

than 400 mm;

than 400 mm;

(All of these

CHF

CHF, CYF

parameters

Channel

should be met.)

Inner Diameter

ø 2, ø 2.2 ø 2.6 (Green)

(mm)

(Blue); ø 2.6 (Green)

(Color Code) Compatible FG Handle

FG Handle: MA-479

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 this instrument and FG Handle as instructed below. Inspect other equipment used with this instrument and FG Handle as instructed in their respective instruction manuals. Should the slightest irregularity be suspected, do not use the instrument or FG Handle; 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 and FG Handle were not sterilized before shipment. Before using this instrument and FG Handle for the first time, reprocess them according to the instructions in Chapter 4, “Reprocessing”. Do not use an instrument or FG Handle 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

3.1

•

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 and FG Handle.

Preparation Equipment and Personal Protective Equipment Prepare all equipment and personal protective equipment which will be used with the instrument and FG Handle 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, FG Handle Always have a spare instrument and FG Handle available.

Reprocessing Equipment Prepare reprocessing equipment as described in Section 4.2, “Required Reprocessing Equipment” for immediate reprocessing after use.

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

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Chapter 3 Preparation, Inspection and Operation

Equipment to be Used in Emergency In case this instrument damages, prepare sharp pliers to cut the insertion portion of this instrument.

3.2

Inspection Wear the protective equipment as specified in the Table on page 35. Before each case, always inspect the instrument and FG Handle according to the following procedures. If an abnormality in the instrument or FG Handle is detected, use a spare instrument or FG Handle, 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 or FG Handle has been compromised. Use a spare instead.

Appearance Inspection If any of following steps reveals irregularities, do not use the instrument or FG Handle; use a spare instead.

 Inspecting the Instrument 1. While operating the Operating Pipe to open and close the Grasping Basket, confirm that there is no peeling or looseness at connecting section.

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