Olympus BML-110 Instructions

0 (0)

INSTRUCTIONS

MECHANICAL LITHOTRIPTOR

BML-110A-1

AUTOCLAVABLE

USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.

			Contents
Contents
Symbols..................................................................			1
Important Information — Please Read Before Use 2
Intended Use .....................................................................			2
Instruction Manual .............................................................			2
User Qualifications.............................................................			2
Instrument Compatibility ....................................................			3
Reprocessing and Storage ................................................			3
Repair and Modification .....................................................			3
Signal Words .....................................................................			4
Warnings............................................................................			4
Chapter 1 Checking the Package Contents.....			6
1.1	Checking the Package Contents ..............................		6
Chapter 2 Instrument Nomenclature and
		Specifications ...................................	7
2.1	Nomenclature and Functions....................................		7
2.2	Specifications............................................................		9
Chapter 3 Preparation, Inspection and
		Operation ..........................................	12
3.1	Preparation ...............................................................		13
3.2	Inspection .................................................................		13
3.3	Operation ..................................................................		18
Chapter 4		Emergency Treatment......................	29
4.1	Emergency Treatment ..............................................		29
Chapter 5		Reprocessing....................................	34
5.1	General Policy ..........................................................		34
5.2	Required Reprocessing Equipment ..........................		37
5.3	Cleaning....................................................................		39
5.4	Lubrication ................................................................		41
5.5	Sterilization ...............................................................		42
MECHANICAL LITHOTRIPTOR BML-110A-1			i

Contents

Chapter 6 Storage ..............................................		44
6.1	Inspection Before Storage ........................................	44
6.2	Storage .....................................................................	45

ii	MECHANICAL LITHOTRIPTOR BML-110A-1

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

MECHANICAL LITHOTRIPTOR BML-110A-1

Important Information — Please Read Before Use

Important Information — Please

Read Before Use

Intended Use

This instrument has been designed to be used with an Olympus lithotriptor and basket type Grasping Forceps for crushing biliary calculi in the bile duct and removing the basket from the patient. This instrument should be used when the basket cannot be removed from the patient through normal procedures. 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	MECHANICAL LITHOTRIPTOR BML-110A-1

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 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 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.

MECHANICAL LITHOTRIPTOR BML-110A-1

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 warning described below when handling this instrument. This information is to be supplemented by the warnings described in each chapter.

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

•Do not use this lithotriptor BML-110A-1 for a calculus that is assumed impossible to be crushed by this lithotriptor. The basket wire etc. may break and part of this lithotriptor may remain in the body.

4	MECHANICAL LITHOTRIPTOR BML-110A-1

Important Information — Please Read Before Use

•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.

•Operation of this instrument is based on the assumption that open surgery is possible as an emergency measure. If the calculus is too hard, it is possible that the damages shown in Chapter 4, “Emergency Treatment” may occur. Use this instrument by considering that it may lead to damaging the Grasping Forceps and that open surgery may have to take place.

MECHANICAL LITHOTRIPTOR BML-110A-1

Chapter 1 Checking the Package Contents

Chapter 1 Checking the Package

Contents

1.1Checking 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 5, “Reprocessing”.

Set

Handle

Coil Sheath (MAJ-403)

Instruction Manual

Coil Sheath (MAJ-403)

Coil Sheath (1 piece)

6	MECHANICAL LITHOTRIPTOR BML-110A-1

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument

Nomenclature and

Specifications

2.1Nomenclature and Functions

This instrument consists of a Coil Sheath and a Handle. This instrument must be used in combination with the wire of the Mechanical Lithotriptor or basket type Grasping Forceps.

Coil Sheath

1. Stopper

Lot Number

2. Model Reference Label

Insertion Portion/

Working Length

Distal End

MECHANICAL LITHOTRIPTOR BML-110A-1

Chapter 2 Instrument Nomenclature and Specifications

Handle

4. Clamping Screw

3. Sheath Insertion Hole

Center Rod

Ratchet Wheel

5. Wire Insertion Hole

Grip

6. Rotatable Bar

7.Ratchet Stopper

8.Model Reference Label

Lot Number

8	MECHANICAL LITHOTRIPTOR BML-110A-1

Chapter 2 Instrument Nomenclature and Specifications

1.Stopper

Fits into the Handle’s Sheath Insertion Hole to prevent separation of the Coil Sheath from the Handle.

2.Model Reference Label

Indicates the product number.

A green reference label indicates that the instrument is autoclavable.

3.Sheath Insertion Hole

Holds the Stopper of the Coil Sheath to prevent separation of the Coil Sheath from the Handle.

4.Clamping Screw

Tightened to fix the Stopper of the Coil Sheath.

5.Wire Insertion Hole

Insert the wire here to coil it onto the Center Rod.

6.Rotatable Bar

When turned, this coils the wire onto the Center Rod.

7.Ratchet Stopper

Engages the Ratchet Wheel to prevent the Center Rod from reversing.

8.Model Reference Label

Indicates the product number.

A green reference label indicates that the instrument is autoclavable.

2.2Specifications

The compatible Olympus Endo-Therapy Accessories are listed in the Table on the following page. New Endo-Therapy Accessories released after the introduction of this instrument may also be compatible for use in combination with this instrument. For further details, contact Olympus.

MECHANICAL LITHOTRIPTOR BML-110A-1

Chapter 2 Instrument Nomenclature and Specifications

•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)

Specifications

Model	BML-110A-1

Shape of the Distal End

Maximum Insertion

ø 3.9

Portion Diameter (mm)

10	MECHANICAL LITHOTRIPTOR BML-110A-1

Chapter 2 Instrument Nomenclature and Specifications

Working Length (mm)	900

Compatible Olympus Basket Type	FG-22Q-1, FG-23Q-1,
Grasping Forceps and	FG-301Q, FG-401Q,
Mechanical Lithotriptors	FG-402Q, FG-403Q,
	FG-V401QR, FG-V402QR,
	FG-V411Q, FG-V412Q,
	BML-1Q-1, BML-2Q-1,
	BML-3Q-1, BML-4Q-1,
	BML-201Q, BML-202Q,
	BML-203Q, BML-204Q,
	BML-V232QR-26,
	BML-V232QR-30,
	BML-V237QR-30,
	BML-V242QR-30,
	BML-V437QR-30,
	BML-V442QR-30


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

MECHANICAL LITHOTRIPTOR BML-110A-1

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 an infection control risk, tissue irritation, punctures, hemorrhages or mucous membrane damage and may result in more-severe equipment damage.

•The instrument was not sterilized before shipment. Before using the 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.

12	MECHANICAL LITHOTRIPTOR BML-110A-1

+ 36 hidden pages