BML-3Q-1 and 4Q-1 MECHANICAL LITHOTRIPTOR Instructions July 2006

Contents

Contents Symbols Important Information–Please Read Before Use Intended Use... Instruction Manual... User Qualifications... Instrument Compatibility... Reprocessing and Storage... Repair and Modification... Signal Words... Warnings and Cautions...

Chapter 1 1.1

Checking the Package Contents

Checking the Package Contents...

Chapter 2

2 2 2 3 3 3 4 4

6

Instrument Nomenclature and Specifications

2.1 2.2

Nomenclature and Functions... Specifications...

Chapter 3

8 14

Preparation, Inspection and Operation

3.1 3.2 3.3

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

Chapter 4 4.1

5.1 5.2 5.3 5.4 5.5 5.6

Emergency Treatment

Emergency Treatment...

Chapter 5

19 20 31

45

Reprocessing

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

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55 59 61 67 69 73

i

Contents

Chapter 6 6.1 6.2

ii

Storage

Inspection Before Storage... Storage...

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77 77

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. Single use only Use by (expiration date) STERILE EO

Sterilized using ethylene oxide

STERILE LOT

Sterilization lot number

LOT

Lot number Manufacturer Authorised representative in the European Community

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Important Information–Please Read Before Use

Important Information–Please Read Before Use Intended Use These instruments have been designed to be used with an Olympus endoscope for crushing calculi inside the bile duct. Do not use these instruments for any purpose other than their 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

MECHANICAL LITHOTRIPTOR

Important Information–Please Read Before Use

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 and/or equipment damage.

Reprocessing and Storage The Basket Wire was shipped in a sterile condition. Store it following the instructions in Chapter 6, “Storage”. Improper storage can present an infection control risk, cause equipment damage or reduce performance. The Basket Wire is a single-use, disposable item that is not to be reprocessed. Do not reuse or attempt to sterilize it. The Coil Sheath, the Tube Sheath and the BML Handle were not sterilized before shipment. Before using the Coil Sheath, the Tube Sheath and the BML Handle for the first time, reprocess them according to the instructions in Chapter 5, “Reprocessing”. After using the Coil Sheath, Tube Sheath and BML Handle, reprocess and store them according to the instructions in Chapter 5, “Reprocessing” and Chapter 6, “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 and BML Handle do not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair them; patient or user injury and/or 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. NOTE

Indicates additional helpful information.

Warnings and Cautions Follow the warning given below when handling this instrument and the BML Handle. This information is to be supplemented by the warnings described in each chapter.

4

S

Before use, thoroughly review the method of use for this instrument and BML-110A-1 in accordance with the instruction manuals.

S

Do not use this instrument for a calculus that is assumed impossible to be crushed by a lithotriptor. The pipe or the basket wire may break and part of this instrument may remain in the body.

S

Use this instrument by having the settings to switch to open surgery and the hospitalization plan ready in case the calculus cannot be crushed by lithotriptor BML-110A-1.

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Important Information–Please Read Before Use

S

A Lithotriptor cannot always crush all calculi captured in the Basket. Operation of this instrument is based on the assumption that open surgery is to be possible as an emergency measure. If the calculus is too hard, there is possibility that the damages shown in Chapter 4 “Emergency Treatment” may occur. Use this instrument by considering that it may lead to damaging the instrument and that open surgery may have to take place.

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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 damage. If the instrument or the BML Handle is damaged, a component is missing or you have any questions, do not use the instrument or the BML Handle; immediately contact Olympus. The Coil Sheath, the Tube Sheath and the BML Handle were not sterilized before shipment. Before using the Coil Sheath, the Tube Sheath and the BML Handle for the first time, reprocess them according to the instructions in Chapter 5, “Reprocessing”.

` A set

Coil Sheath and Tube Sheath (Reusable)

Instruction Manual

Basket Wire (Sterile, Single use only)

6

BML Handle (MAJ-440, Reusable)

MECHANICAL LITHOTRIPTOR

Chapter 1 Checking the Package Contents

` B set Coil Sheath (Reusable, 1 piece) Tube Sheath (Reusable, 1 piece) Basket Wire (Sterile, single use only, 2 pieces) Instruction Manual

` Coil Sheath Coil Sheath (Reusable, 1 piece)

` Tube Sheath Tube Sheath (Reusable, 1 piece)

` Basket Wire Basket Wire (Sterile, single use only, 1 piece)

` BML Handle BML Handle (MAJ-440, reusable, 1 piece)

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Chapter 2 Instrument Nomenclature and Specifications

Chapter 2

2.1

Instrument Nomenclature and Specifications

Nomenclature and Functions This instrument consists of a Coil Sheath, Tube Sheath and Basket Wire. The Tube Sheath is inserted into the Coil Sheath and the Basket Wire is inserted into the Tube Sheath prior to use. This instrument must be used in combination with the BML Handle.

` Coil Sheath (Reusable) 4. Fixing Screw Notch 3. Knob

Slide Region

2. Identification Mark 1. Model Reference Label

Lot Number

Insertion Portion/Working Length

8

MECHANICAL LITHOTRIPTOR

Chapter 2 Instrument Nomenclature and Specifications

` Tube Sheath (Reusable)

7. Stopper 1. Model Reference Label 6. Port 2. Identification Mark 5. Guide Pin

Guide Pipe

8. Tube

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Chapter 2 Instrument Nomenclature and Specifications

` Basket Wire (Sterile, Single use only) 9. Wire Joint Protective Tube 2. Identification Mark Basket Tip

Pipe

Basket Protective Tube

Lot Number

Wire

10

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Chapter 2 Instrument Nomenclature and Specifications

` BML Handle (MAJ-440, Reusable) Lot Number 16. Clamping Screw

15. Insertion Hole

14. Outlet Grip 13. Rotatable Knob

12. Screw 11. Button

Rack 10. Checking Window

14. Outlet

17. Holder 11. Button 12. Screw

Button Unlocked

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Button Locked

11

Chapter 2 Instrument Nomenclature and Specifications

1. Model Reference Label Indicates the product number. A green reference label indicates that the instrument is autoclavable. 2. Identification Mark The Coil Sheath, Tube Sheath and Basket Wire are marked as follows for each model. Model

BML-3Q-1

BML-4Q-1

Side Region 3 black stripes

Side Region 4 black stripes

Guide Pipe 3 black stripes

Guide Pipe 4 black stripes

Pipe 3 black stripes

Pipe 4 black stripes

Coil Sheath

Tube Sheath

Basket Wire

3. Knob Used to slide the Coil Sheath. Locks the position of the Slider Region when tightened. 4. Fixing Screw Secures the Tube Sheath when tightened. 5. Guide Pin Aligned with the Notch at the proximal end of the Coil Sheath to properly align the Coil Sheath with the Tube Sheath. 6. Port Attach a syringe here to inject contrast medium (BML-3Q-1 only) or flush reprocessing chemicals, water and air through the Tube Sheath when reprocessing (BML-3Q-1 and BML-4Q-1). 12

MECHANICAL LITHOTRIPTOR

Chapter 2 Instrument Nomenclature and Specifications

7. Stopper Attached to the BML Handle. 8. Tube On the BML-3Q-1, 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 are flushed to the distal end when reprocessing. 9. Wire Joint Attached to the Holder of the BML Handle. If the Wire Joint has groove on it, the handling, operating and maintenance procedures described in this manual are applicable. 10. Checking Window Allows user to view the Wire Joint when attaching it to the Holder of the BML Handle. 11. Button Secures and releases the Wire Joint of the Basket Wire. 12. Screw Turn the Screw to lock and unlock the Button. 13. Rotatable Knob When turned, the Basket is gradually retracted in order to crush the calculi. 14. Outlet Discharge the remaining lubricant from here when reprocessing. 15. Insertion Hole The Basket Wire’s Pipe and the Tube Sheath’s Stopper are inserted here. 16. Clamping Screw Tightened to secure the Stopper of the Tube Sheath. 17. Holder Moved back and forth to open and close the Basket when the BML Handle is connected to the instrument.

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Chapter 2 Instrument Nomenclature and Specifications

2.2

Specifications The compatible Olympus endoscopes are listed in the Table on the following page. New endoscopes released after the introduction of this instrument and BML Handle may also be compatible for use in combination with this instrument and BML Handle. For further details, contact Olympus. Use this instrument and BML Handle only in combination with products recommended by Olympus. If combined with products not recommended by Olympus, patient or operator injury, malfunction and/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)

Specifications The recommended Coil Sheath, Tube Sheath and Basket Wire combinations for each instrument are as follows: Do not use the Coil Sheath, Tube Sheath or Basket Wire in combinations other than those listed below. An incorrect combination could cause patient injury and/or equipment damage.

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MECHANICAL LITHOTRIPTOR

Chapter 2 Instrument Nomenclature and Specifications

Product Name

BML-3Q-1

BML-4Q-1

Coil Sheath

MAJ-242

MAJ-245

Tube Sheath

MAJ-243

MAJ-246

Basket Wire

MAJ-244

MAJ-247

Model

BML-3Q-1

BML-4Q-1

ø 3.7

ø 2.9

Shape of the Grasping Basket

Maximum Insertion Portion Diameter (mm) Working Length (mm)

1950

Opening Length (mm)

30

Compatible Olympus Endoscopes (All of the parameters should be met.)

Model and Length

Channel Inner Diameter (mm) (Color Code)

Working Length less than 1400 mm; TJF

Working Length less than 1400 mm; JF, TJF

ø 4.2 (Orange); ø 5.5 (Pink)

ø 3.2 (Yellow); ø 4.2 (Orange); ø 5.5 (Pink)

Compatible Olympus Handle

BML Handle: MAJ-440

Compatible Olympus Lithotriptor for Emergency Use

BML-110A-1

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Chapter 2 Instrument Nomenclature and Specifications

Medical Device Directive

16

0197

This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class I

MECHANICAL LITHOTRIPTOR

Chapter 3 Preparation, Inspection and Operation

Chapter 3

Preparation, Inspection and Operation

The Basket Wire was shipped in a sterile condition. The Coil Sheath, the Tube Sheath and the BML Handle were not sterilized before shipment. S

Do not use the Basket Wire after the expiration date displayed on the sterile package. Doing so may pose an infection control risk and/or cause tissue irritation.

S

When using the instrument and the BML Handle, 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, that fit properly and are long enough so that your skin is not exposed.

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