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INSTRUCTIONS

MECHANICAL LITHOTRIPTOR

BML-3Q-1BML-4Q-1

Contents

iMECHANICAL LITHOTRIPTOR

Contents

Symbols

Important Information–Please Read Before UseIntended Use 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Instruction Manual 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . User Qualifications 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Instrument Compatibility 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . Reprocessing and Storage 3. . . . . . . . . . . . . . . . . . . . . . . . . . Repair and Modification 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signal Words 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Warnings and Cautions 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 1 Checking the Package Contents1.1 Checking the Package Contents 6. . . . . . . . . . . . . . . .

Chapter 2 Instrument

Nomenclature and Specifications2.1 Nomenclature and Functions 8. . . . . . . . . . . . . . . . . . . 2.2 Specifications 14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 3 Preparation,

Inspection and Operation3.1 Preparation 19. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2 Inspection 20. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3 Operation 31. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 4 Emergency Treatment4.1 Emergency Treatment 45. . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 5 Reprocessing5.1 General Policy 55. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2 Required Reprocessing Equipment 59. . . . . . . . . . . . . . 5.3 Cleaning 61. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.4 Lubrication 67. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5 Assembly 69. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.6 Sterilization 73. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Contents

ii MECHANICAL LITHOTRIPTOR

Chapter 6 Storage6.1 Inspection Before Storage 77. . . . . . . . . . . . . . . . . . . . . . 6.2 Storage 77. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Symbols

1MECHANICAL LITHOTRIPTOR

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

�� Sterilization lot number

�� Lot number

Manufacturer

Authorised representative in the

European Community

Important Information–Please Read Before Use

2 MECHANICAL LITHOTRIPTOR

Important Information–PleaseRead Before Use

Intended Use

These instruments have been designed to be used with anOlympus endoscope for crushing calculi inside the bileduct. Do not use these instruments for any purpose otherthan their intended use.

Instruction Manual

This instruction manual contains essential information onusing this instrument safely and effectively. Before use,thoroughly review this manual and the manuals of allequipment which will be used during the procedure anduse the instruments as instructed.Keep this and all related instruction manuals in a safe,accessible location.If you have any questions or comments about anyinformation in this manual, please contact Olympus.

User Qualifications

The operator of this instrument must be a physician ormedical personnel under the supervision of a physicianand must have received sufficient training in clinicalendoscopic technique. This manual, therefore, does notexplain or discuss clinical endoscopic procedures.



Instrument Compatibility

Refer to the Table in Section 2.2, “Specifications” toconfirm that this instrument is compatible with the ancillaryequipment being used. Using incompatible equipment canresult in patient injury and/or equipment damage.

Reprocessing and Storage

The Basket Wire was shipped in a sterile condition. Storeit 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 notto be reprocessed. Do not reuse or attempt to sterilize it.The Coil Sheath, the Tube Sheath and the BML Handlewere not sterilized before shipment. Before using the CoilSheath, the Tube Sheath and the BML Handle for the firsttime, reprocess them according to the instructions inChapter 5, “Reprocessing”.

After using the Coil Sheath, Tube Sheath and BML Handle,reprocess and store them according to the instructions inChapter 5, “Reprocessing” and Chapter 6, “Storage”.Improper and/or incomplete reprocessing or storage canpresent an infection control risk, cause equipment damageor reduce performance.

Repair and Modification

This instrument and BML Handle do not contain anyuser-serviceable parts. Do not disassemble, modify orattempt to repair them; patient or user injury and/orequipment damage can result.



Signal Words

The following signal words are used throughout thismanual:

Indicates a potentially hazardoussituation which, if not avoided, couldresult in death or serious injury.

Indicates a potentially hazardoussituation which, if not avoided, may resultin minor or moderate injury. It may also beused to alert against unsafe practices orpotential equipment damage.

NOTE Indicates additional helpful information.

Warnings and Cautions

Follow the warning given below when handling thisinstrument and the BML Handle. This information is to besupplemented by the warnings described in each chapter.

� Before use, thoroughly review themethod of use for this instrument andBML-110A-1 in accordance with theinstruction manuals.

� Do not use this instrument for acalculus that is assumed impossible tobe crushed by a lithotriptor. The pipeor the basket wire may break and partof this instrument may remain in thebody.

� Use this instrument by having thesettings to switch to open surgery andthe hospitalization plan ready in casethe calculus cannot be crushed bylithotriptor BML-110A-1.



� A Lithotriptor cannot always crush allcalculi captured in the Basket.Operation of this instrument is basedon the assumption that open surgery isto be possible as an emergencymeasure. If the calculus is too hard,there is possibility that the damagesshown in Chapter 4 “EmergencyTreatment” may occur. Use thisinstrument by considering that it maylead to damaging the instrument andthat open surgery may have to takeplace.

Chapter 1 Checking the Package Contents


Chapter 1 Checking the PackageContents

1.1 Checking the Package Contents

Match all items in the package with the components shownbelow. Inspect each item for damage. If the instrument orthe BML Handle is damaged, a component is missing oryou have any questions, do not use the instrument or theBML Handle; immediately contact Olympus.The Coil Sheath, the Tube Sheath and the BML Handlewere not sterilized before shipment. Before using the CoilSheath, the Tube Sheath and the BML Handle for the firsttime, reprocess them according to the instructions inChapter 5, “Reprocessing”.

� A set

Coil Sheath and Tube Sheath(Reusable)

Instruction Manual

Basket Wire (Sterile, Single use only) BML Handle (MAJ-440, Reusable)

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)

Chapter 2 Instrument Nomenclature and Specifications


Chapter 2 InstrumentNomenclature andSpecifications

2.1 Nomenclature and Functions

This instrument consists of a Coil Sheath, Tube Sheathand Basket Wire. The Tube Sheath is inserted into the CoilSheath and the Basket Wire is inserted into the TubeSheath prior to use.This instrument must be used in combination with the BMLHandle.

� Coil Sheath (Reusable)

3. Knob

2. Identification Mark

1. Model ReferenceLabel

Lot Number

4. Fixing Screw

Slide Region

Insertion Portion/Working Length

Notch



� Tube Sheath (Reusable)

6. Port


1. Model Reference Label

5. Guide Pin

7. Stopper

8. Tube

Guide Pipe



� Basket Wire (Sterile, Single use only)

9. Wire Joint


Pipe

Lot Number

Wire

Basket

Basket Tip

Protective Tube

Protective Tube



� BML Handle (MAJ-440, Reusable)

Rack

17. Holder

Grip

10. Checking Window14. Outlet

16. Clamping Screw

15. Insertion Hole

14. Outlet

13. Rotatable Knob

11. Button

Lot Number

12. Screw

11. Button

Button Unlocked Button Locked

12. Screw



1. Model Reference LabelIndicates the product number.A green reference label indicates that the instrumentis autoclavable.

2. Identification MarkThe Coil Sheath, Tube Sheath and Basket Wire aremarked as follows for each model.

Model BML-3Q-1 BML-4Q-1

Coil Sheath

Side Region

3 black stripes

Side Region

4 black stripes

Tube Sheath

Guide Pipe

3 black stripes

Guide Pipe

4 black stripes

Basket Wire

Pipe

3 black stripes

Pipe

4 black stripes

3. KnobUsed to slide the Coil Sheath. Locks the position ofthe Slider Region when tightened.

4. Fixing ScrewSecures the Tube Sheath when tightened.

5. Guide PinAligned with the Notch at the proximal end of the CoilSheath to properly align the Coil Sheath with the TubeSheath.

6. PortAttach a syringe here to inject contrast medium(BML-3Q-1 only) or flush reprocessing chemicals,water and air through the Tube Sheath whenreprocessing (BML-3Q-1 and BML-4Q-1).



7. StopperAttached to the BML Handle.

8. TubeOn the BML-3Q-1, works as the channel throughwhich contrast medium is injected during use. It alsoworks as the channel through which reprocessingchemicals, water or air are flushed to the distal endwhen reprocessing.

9. Wire JointAttached to the Holder of the BML Handle. If the WireJoint has groove on it, the handling, operating andmaintenance procedures described in this manual areapplicable.

10. Checking WindowAllows user to view the Wire Joint when attaching it tothe Holder of the BML Handle.

11. ButtonSecures and releases the Wire Joint of the BasketWire.

12. ScrewTurn the Screw to lock and unlock the Button.

13. Rotatable KnobWhen turned, the Basket is gradually retracted inorder to crush the calculi.

14. OutletDischarge the remaining lubricant from here whenreprocessing.

15. Insertion HoleThe Basket Wire’s Pipe and the Tube Sheath’sStopper are inserted here.

16. Clamping ScrewTightened to secure the Stopper of the Tube Sheath.

17. HolderMoved back and forth to open and close the Basketwhen the BML Handle is connected to the instrument.



2.2 Specifications

The compatible Olympus endoscopes are listed in theTable on the following page. New endoscopes releasedafter the introduction of this instrument and BML Handlemay also be compatible for use in combination with thisinstrument and BML Handle. For further details, contactOlympus.

Use this instrument and BML Handle onlyin combination with productsrecommended by Olympus. If combinedwith products not recommended byOlympus, patient or operator injury,malfunction and/or equipment damagemay 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 BasketWire combinations for each instrument are as follows:

Do not use the Coil Sheath, Tube Sheathor Basket Wire in combinations other thanthose listed below. An incorrectcombination could cause patient injuryand/or equipment damage.



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

Shape of theGrasping Basket

Maximum Insertion Portion Diameter (mm)

ø 3.7 ø 2.9

Working Length (mm) 1950

Opening Length (mm) 30

Compatible Olympus

Model and Length

Working

Length less

than 1400

mm;

TJF

Working

Length less

than 1400

mm;

JF, TJF

Endoscopes(All of the parameters

should be met.)

Channel Inner Diameter(mm) (Color Code)

ø 4.2

(Orange);

ø 5.5

(Pink)

ø 3.2

(Yellow);

ø 4.2

(Orange);

ø 5.5

(Pink)

Compatible

Olympus HandleBML Handle: MAJ-440

Compatible

Olympus

Lithotriptor for

Emergency Use

BML-110A-1



Medical Device

Directive 0197

This device complies with the

requirements of Directive

93/42/EEC concerning medical

devices.

Classification: Class I

Chapter 3 Preparation, Inspection and Operation


Chapter 3 Preparation,Inspection andOperation

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

� Do not use the Basket Wire after theexpiration date displayed on the sterilepackage. Doing so may pose aninfection control risk and/or causetissue irritation.

� When using the instrument and theBML Handle, always wear appropriatepersonal protective equipment,Otherwise, blood, mucous and otherpotentially infectious material from thepatient could pose an infection controlrisk. Appropriate personal protectiveequipment may include: Eye wear, aface mask, moisture-resistant clothingand chemical-resistant gloves, that fitproperly and are long enough so thatyour skin is not exposed.



� Before each case, prepare and inspectthe instrument and the BML Handle asinstructed below. Inspect otherequipment to be used with theinstrument and the BML Handle asinstructed in their respectiveinstruction manuals.Should the slightest irregularity besuspected, do not use the instrumentor the BML Handle; contact Olympus.Damage or irregularity maycompromise patient or user safety,since it may pose an infection controlrisk, cause tissue irritation, punctures,hemorrhages or mucous membranedamage. It may also result in moresevere equipment damage.

� The coil Sheath, the Tube Sheath andthe BML Handle were not sterilizedbefore shipment. Before using the CoilSheath, the Tube Sheath and the BMLHandle for the first time, reprocess andassemble them according to theinstructions in Chapter 5,“Reprocessing”.Do not use an instrument or the BMLHandle that has not been cleaned andsterilized. This could pose an infectioncontrol risk and/or can cause tissueirritation.

� Do not coil the Insertion Portion with adiameter of less than 15 cm. Thiscould damage the Insertion Portion.

� Never use excessive force to operatethe instrument and the BML Handle.This could damage the instrumentand/or the BML Handle.



3.1 Preparation

Equipment and Personal Protective Equipment

Prepare all equipment and personal protective equipmentwhich will be used with the instrument and BML Handle inaccordance with their respective instruction manuals.Appropriate personal protective equipment may include:Eye wear, a face mask, moisture-resistant clothing andchemical-resistant gloves.

Spare Instrument and BML Handle

Always have a spare instrument and BML Handleavailable.

Sterilized Syringe and Contrast Medium forInspection

Prepare a sterile syringe and contrast medium forinspection.

Reprocessing Equipment

Prepare reprocessing equipment as described in Section5.2, “Required Reprocessing Equipment” for immediatereprocessing after use.



Equipment to be Used in Emergency

Always have pliers ready to cut the Coil Sheath, TubeSheath and/or Basket Wire in case lithotripsy cannot beperformed. Also have the Olympus LithotriptorBML-110A-1 ready.

3.2 Inspection

Wear the personal protective equipment as specified in theTable on page 59.

Before each case, always inspect the instrument and theBML Handle according to the following procedures.If an abnormality in the instrument or the BML Handle isdetected, use a spare instrument or BML Handle,inspecting it thoroughly before use.

Inspection of the Sterile Package

Inspect the sterile package for tears, inadequate sealingor water damage. If the sterile package shows anyirregularities, the sterile condition of the instrument or theBML Handle may have been compromised. Use a spareinstead.

Appearance Inspection

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

Before use, carefully inspect the entirecoil sheath as instructed in this chapter;confirm that it is not crushed, bent,deformed or otherwise damaged. Adamaged coil sheath may not be able toproperly crush a calculus and/or it couldcause the instrument to break.



� Inspecting the Instrument

Be sure to inspect the Coil Sheath beforeassembly. Never attempt to use theinstrument if you suspect that the CoilSheath has an irregularity or is damaged.If an instrument in this condition is used,it may malfunction or cause patient injury,such as punctures, hemorrhages ormucous membrane damage. Equipmentdamage and performance deteriorationmay also result.

When pulling the Basket Wire out of theProtective Tube, take care not to bend thePipe of the Basket Wire. This coulddamage the Basket Wire.

1. Straighten the Protective Tube containing the BasketWire. Then, hold the Basket Tip and withdraw theBasket Wire all the way. Dispose of the ProtectiveTube. (See Figure 3.1)

Basket Tip

Basket

Protective Tube

Figure 3.1



NOTE Do not withdraw the Basket Wire forciblyif the Wire Joint catches on the ProtectiveTube. Use your fingers to gently extricatethe part of the Basket Wire that is caughtand then withdraw it.

2. Confirm that the Coil Sheath, Tube Sheath andBasket Wire are free from disconnection orlooseness.

3. Gently run your fingertips over the entire length of theCoil Sheath and Tube Sheath to check for anycrushed areas, excessive bends, etc..

4. Confirm that there is no unraveled, disconnected orbroken wires, sharp protrusions, sharp edges or anyother apparent abnormalities of the Basket Wire.

� Inspecting the BML Handle

Make sure that there are no cracks on the BML Handle.

Assembling and Inspection

� Do not use excessive force whenassembling the instrument. This coulddamage the instrument.

� Be sure to keep the Coil Sheath andTube Sheath straight whenassembling the instrument. If the CoilSheath or Tube Sheath is not straight,the instrument could be damaged.

� Move the Basket Wire’s Pipe back andforth slowly. Fast or abrupt movementcould damage the Pipe.

1. Straighten the Tube Sheath.

2. Insert the Basket Wire into the proximal end of theTube Sheath as shown in Figure 3.2.



Tube Sheath Wire Joint

Figure 3.2

NOTE The Basket Wire’s Pipe bends easily. Useextra care when handling it.

3. Extend the Wire Joint from the Stopper on theproximal end of the Tube Sheath as shown in Figure3.3.

Tube Sheath

Wire Joint

Stopper

Figure 3.3



NOTE Force is sometimes required to extend theWire Joint from the Stopper on theproximal end of the Tube Sheath. If thisis the case, do not try to insert the WireJoint forcibly. Keep the insertion portionsof the Coil Sheath and Tube Sheath asstraight as possible.

4. Withdraw the Pipe from the Stopper until the Basketis completely closed.

5. While operating the Pipe to open and close theBasket, confirm that the Basket Wire is free fromdisconnection or looseness.

6. Open the Basket. Make sure that there are nounraveled, disconnected or broken Wires, sharpprotrusions, sharp edges or any other apparentabnormalities.

7. Make sure that there are no excessive bends, sharpedges or other apparent deformations in the Pipe ofthe Basket Wire.

8. Confirm that the distal end of the Basket Wire appearsexactly as shown in the Table in Section 2.2“Specifications” and is not damaged.

Making and Inspecting the Connections

� Make sure the screw is tightened. Ifnot securely tightened, the pipe maydisattach, the basket may not to bemoved, and/or the calculus may not becrushed.



� Make sure to have the stopper and theBML handle connected. If theinstrument separates from the BMLhandle during operation, the pipe maybreak or become uncontrollable. Also,this instrument with calculus engagedmay not be removed from the body.

� Do not hold the BML Handle by theHolder if the Tube Sheath’s Stopper isnot connected. The weight of theinstrument could bend the BasketWire.

� Make sure that the Tube Sheath’sStopper is securely attached to theBML Handle. If the BML Handle’sHolder is extended when the Handle isnot attached firmly, the instrumentmay become detached and the BasketWire could be damaged.

� When connecting the BML Handlewith the Wire Joint, fully unlock theButton on the Handle’s Holder byturning the Screw. If the Button ispressed before the Screw iscompletely unlocked, the Basket Wiremay come off from the BML Handle,and it may lead to malfunctioning of thehandle or breakage of the Wire Joint.

NOTE The Screw on the BML Handle may belocked so that the Button cannot bepressed by mistake, which would causethe Basket Wire to be disconnected.

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

1. Turn the Screw on the BML Handle counterclockwiseto unlock the Button. (See Figure 3.4)



Screw

1. Unlock the Button2. Press the Button

Button

Figure 3.4

2. Loosen the Clamping Screw of the BML Handle byturning it counterclockwise until it stops.

3. Push the Holder of the BML Handle as far as it can go.

4. Insert the Basket Wire’s Pipe into the BML Handle’sInsertion Hole as far as it can go. (See Figure 3.5)

Wire Joint

Pipe

Grip

ClampingScrew

Insertion Hole

Figure 3.5



5. After completing Step 4., press the Button on the BMLHandle’s Holder (See Figure 3.4). While pressing theButton, insert the Basket Wire’s Pipe further into theInsertion Hole until it stops. (See Figure 3.5)

6. Release the Button when the Pipe can be inserted nofurther.

7. Confirm that Wire Joint of Basket is visible Wirethrough the Slit (See Figure 3.6). Then, push and pullthe Basket Wire’s Pipe to make sure that the WireJoint is securely attached to the Holder.

Holder

Wire Joint

Checking Window

Figure 3.6

8. Insert the Tube Sheath’s Stopper as far as possibleinto the BML Handle’s Insertion Hole.(See Figure 3.7)



ClampingScrew

Pipe

Tube SheathInsertion Hole

Stopper

Figure 3.7

9. Tighten the BML Handle’s Clamping Screw by turningit clockwise until it stops. (See Figure 3.7)

10. Turn the Screw on the BML Handle clockwise to lockthe Button. (See Figure 3.8)

Screw

Button

Figure 3.8

11. Push and pull the Slide Region of the Coil Sheath tomake sure the Tube Sheath’s Stopper is securelyattached to the BML Handle.



Inspection of Operation

After assembly, check that no abnormalityis detected in the action of the handle. Ifthere is any abnormality, the calculus maynot be crushed and/or the instrument withstone engaged may not be removed fromthe body.

If the instrument does not operate smoothly and asintended, do not use the instrument or the BML Handle;use a spare instead.

1. Holding the instrument and the BML Handle as shownin Figure 3.9, form a loop in the Insertion Portionapproximately 20 cm in diameter.

Open

Close

Slide

Approximately 20 cm.

Figure 3.9

2. Operate the Holder and confirm that the Basket opensand closes smoothly.

3. Move the Coil Sheath’s Knob back and forth to makesure that it slides smoothly.



4. Move the Coil Sheath’s Knob until it sits in the groovenearest to the Identification Mark. Make sure that theTube Sheath does not extend from the distal end ofthe Coil Sheath.

Inspecting Irrigation

Perform the following inspection only when using theBML-3Q-1. Irrigation inspection is not necessary whenusing the BML-4Q-1.

NOTE The BML-4Q-1 is not designed forinjection of a contrast medium.

Do not use the instrument if the contrast medium cannotbe injected or if it leaks from any area other than the distalend. In this case, use a spare instead.

Use a contrast medium intended forpatient use when inspecting irrigation.Other fluids may remain inside thechannel and pose an infection control riskand/or cause tissue irritation.

1. Open the Basket and inject a contrast medium into theinstrument’s Port using a sterile syringe. Confirm thatthe contrast medium only comes out of the distal endof the instrument. (See Figure 3.10)



Tube Sheath

Syringe

Coil SheathPort

Grip

Figure 3.10

2. Make sure that the contrast medium does not leakfrom any area other than the distal end of theinstrument.

3. Connect a sterile syringe to the instrument’s Port.Inject air into the Insertion Portion to discharge thecontrast medium.

3.3 Operation

The operator of the instrument and the BML Handle mustbe a physician or medical personnel under the supervisionof a physician and must have received sufficient trainingin clinical endoscopic technique.This manual, therefore, does not explain or discuss clinicalendoscopic procedures. It only describes basic operationand precautions related to the operation of this instrumentand BML Handle.



� Operation of this instrument is basedon the assumption that open surgery ispossible as an emergency measure.In the course of crushing a hardcalculus, the pipe and/or the basketwire could break and fall off of theinstrument inside the patient. If thepipe or basket wire is damaged duringuse, immediately stop using theinstrument and follow the appropriateinstruction(s) given in Chapter 4,“Emergency Treatment”.

� Do not insert the instrument into theendoscope unless you have a clearendoscopic field of view. If you cannotsee the distal end of the InsertionPortion in the endoscopic field of viewor in X-ray images, do not use it. Thiscould cause patient injury, such aspunctures, hemorrhages or mucousmembrane damage. It may alsodamage the endoscope and/orinstrument.

� Do not angulate the Bending Sectionof the Endoscope or operate theForceps Elevator abruptly while thedistal end of the Insertion Portion isextended from the Distal End of theendoscope. This could cause patientinjury, such as punctures,hemorrhages or mucous membranedamage.

� Do not force the distal end of theInsertion Portion against body cavitytissue. This could cause patient injury,such as punctures, hemorrhages ormucous membrane damage.



Inserting Into the Endoscope

� Do not insert the instrument into theendoscope, if the Basket is notcompletely retracted into the InsertionPortion. The distal end of the InsertionPortion may extend from the DistalEnd of the endoscope tip abruptly.This could cause patient injury, suchas punctures, hemorrhages ormucous membrane damage. It mayalso damage the endoscope and/orinstrument.

� When inserting the instrument into theendoscope, raise the ForcepsElevator to its maximum height. If theForceps Elevator is down, you will notbe able to see the distal end of theInsertion Portion in the endoscopicfield of view. This could cause patientinjury, such as punctures,hemorrhages or mucous membranedamage.

� When inserting the instrument into theendoscope, hold the Holder firmly.Otherwise, the Basket may extendfrom the Distal End of the endoscopeabruptly. This could cause patientinjury, such as punctures,hemorrhages or mucous membranedamage. It may also damage theendoscope and/or instrument.



� Do not force the instrument, ifresistance to insertion is encountered.Reduce the angulation or lower theForceps Elevator of the endoscopeuntil the instrument passes smoothly.This could cause patient injury, suchas punctures, hemorrhages ormucous membrane damage. It mayalso damage the endoscope and/orinstrument.

� Do not advance or extend theinstrument abruptly. This could causepatient injury, such as punctures,hemorrhages or mucous membranedamage. It could also damage theendoscope and/or instrument.

� When inserting the instrument into theendoscope, hold it close to the BiopsyValve and keep it as straight aspossible relative to the Biopsy Valve.Otherwise, the Insertion Portion couldbe damaged.

� Insert the instrument slowly. Abruptinsertion may damage the endoscopeand/or instrument.

1. Raise the Forceps Elevator to its maximum height.

2. Loosen the Coil Sheath’s Knob by turning it clockwiseand slide the Knob toward the proximal end until itstops as shown in Figure 3.11. Tighten the Knob tosecure it in position.



Knob

Coil Sheath

Tube Sheath

Figure 3.11

3. Retract the Basket into the Tube Sheath.

4. With the Basket retracted, carefully insert theinstrument into the Biopsy Valve of the endoscope.(See Figure 3.12)

Coil Sheath

Keep as straight as possible.

Hold the InsertionPortion close to theBiopsy Valve.Biopsy Valve

Figure 3.12

5. When the distal end of the Insertion Portion contactsthe Forceps Elevator, lower the Forceps Elevator.



6. Advance the instrument another 20 mm and raise theForceps Elevator. You will see the distal end of theinstrument in the endoscopic field of view.

Inserting Into the Bile Duct

Do not forcibly insert the Insertion Portioninto the Bile Duct. This could causepatient injury, such as punctures,hemorrhages or mucous membranedamage.

Insert the distal end of the instrument into the bile duct viathe opening in the duodenal papilla.

NOTE If resistance is too strong and insertion ofthe instrument is difficult, lower theForceps Elevator and move the distal endof the instrument slightly forward. Thenraise the Forceps Elevator.

Grasping

� Do not withdraw this instrument withstone engaged from the bile ductabruptly and/or with excessive force.This could cause punctures,hemorrhages, mucous membranedamage or edema.

� Do not push the Holder abruptly, as itmay cause the Basket to openabruptly. This could cause patientinjury, such as punctures,hemorrhages or mucous membranedamage. It could also damage theendoscope and/or instrument.



� When the lithotriptor’s basket does notsmoothly open or close, do not applyforce but move the forceps elevator orthe scope’s angle back, or move theposition of the basket until the basketopens or closes with ease. If theaction is forced, the tube may stretchand cannot be stored inside the coilsheath. Also, the calculus may not becrushed, and/or the instrument withcalculus engaged may not be removedfrom the body.

� Do not grasp calculi forcibly as thiscould deform the distal end of the TubeSheath. This could damage theinstrument.

� Do not open and close the Basket tooquickly. Doing so could damage theinstrument.

1. To grasp the target calculi, angulate the endoscopeand/or advance the instrument required distance.

2. Push the Holder to open the Basket.

3. Surround the target calculus, with the open Basket.

4. Pull the Holder to grasp the target calculis.



Crushing the Calculi

� This instrument will deform and/ordeteriorate by performing lithotripsy.When lithotripsy is repeated, it willdeform and/or deterioratefurthermore. By such deformationand/or deterioration, calculus may notbe crushed and/or the instrument withcalculus engaged may not be removedfrom the body. If lithotripsy is requiredto be repeated in a single case, makesure to check each time that noabnormality is found in action and/orappearance (e.g. basket wire cut orworn, tube sheath bent, notable coilsheath bent or gap etc.). Stop usewhen any abnormality is detected.

� If resistance is too great and it isdifficult to slide the Coil Sheath, adjustthe angulation of the endoscope untilthe Coil Sheath slides smoothly.Forcible sliding may cause the distalend of the Coil Sheath to extendabruptly. This could cause patientinjury, such as punctures,hemorrhages or mucous membranedamage. It may also damage theendoscope and/or instrument.

� During lithotripsy, keep the portion;from the coil sheath to the BMLhandle, straight in line with the scope’sbiopsy valve, as much as possible. Ifnot straight, the coil sheath may bend,calculus may not be crushed, and/orthe instrument with calculus engagedmay not be removed from the body.



� Do not rotate the BML handle knobabruptly. This instrument may break,and/or calculus may not be crushed.Also, the instrument with calculusengaged may not be removed from thebody.

� Lower the endoscope’s forcepselevator when performing lithotripsy.If lithotripsy is performed when theelevator is not lowered, the scope orthe instrument may break and/or thecalculus may not be crushed. Also,the instrument with calculus engagedmay not be removed from the body.

� Do not forcibly push or pull theinstrument or the BML Handle duringlithotripsy. This could cause patientinjury, such as punctures,hemorrhages or mucous membranedamage. It may also damage theendoscope and/or instrument.

� During lithotripsy, make sure to havethe knob of the coil sheath properly setin the groove of the slider part. If thecoil sheath moves, the stone may notbe crushed and/or the instrument withcalculus engaged may not be removedfrom the body.

� Do not push the BML handle’s holderforcibly when the basket does notopen after crushing the calculus. As itmay cause the basket to openabruptly. This could cause patientinjury, such as punctures,hemorrhages or mucous membranedamage. It could also damage theendoscope and/or instrument.



� When making the coil sheath slide,confirm under X-ray image that thetube sheath is completely covered bycoil sheath. If not completely covered,the calculus may not be crushedand/or the instrument with calculusengaged may not be removed from thebody.

While rotating the Knob, it will generateresistance in the opposite direction. Donot loosen your grip because the Knobcould create friction that could hurt yourhand.

1. Lower the Forceps Elevator.

2. Loosen the Knob on the Coil Sheath.

3. While gently inserting the Coil Sheath, slowly movethe Knob as shown in Figure 3.13.

Figure 3.13



NOTE The operation shown in Figure 3.13requires coordination between theoperator and assistant. Practice thisoperation before actually performing it ona patient.

4. While observing the X-ray image, move the distal endof the Coil Sheath in front of the calculus. Cover theTube Sheath completely with the Coil Sheath. Then,set the Knob in the groove nearest possible to theIdentification Marks, and tighten the Knob.(See Figure 3.14)

Slide Region

Figure 3.14

5. Make sure that the Knob is firmly attached to the SlideRegion.

6. Without releasing the calculus, turn the RotatableKnob on the BML Handle in the direction of arrow.This will cause the Basket to squeeze the calculus,crushing it.



NOTE � The Basket Wire, Coil Sheath and/orTube Sheath may become deformedwhen strong force is used to crush acalculus. In this case, replace thedeformed Basket Wire, Coil Sheath orTube Sheath with a spare.

� To prevent damaging the instrument,the Rotatable Knob on the BMLHandle can be turned even when theHolder is fully extended. At this point,the Basket cannot be pulled in anyfurther. If this condition occurs, stopturning the Rotatable Knob.

Withdrawing the Instrument From the Endoscope

� Do not withdraw the instrumentabruptly from the bile duct. It couldcause mucous membrane damage oredema.

� Do not withdraw the instrument fromthe endoscope quickly. This couldscatter blood, mucous or other patientdebris and pose an infection controlrisk.

� Do not withdraw the instrument fromthe endoscope if the Basket is notcompletely retracted into the TubeSheath. This could damage theendoscope and/or instrument.

� Do not withdraw the instrument fromthe endoscope if the Forceps Elevatoris up. This could damage theendoscope and/or instrument.

1. Pull the Holder to retract the Basket into the TubeSheath.



2. Withdraw the instrument from the endoscope.

Detaching

Do not pull the Basket Wire from the TubeSheath quickly. Do not pull the TubeSheath from the Coil Sheath quickly. Thiscould scatter blood, mucous or otherpatient debris and pose an infectioncontrol risk.

1. Loosen the Clamping Screw on the BML Handle byturning it counterclockwise and remove the CoilSheath and Tube Sheath.

2. Turn the Screw on the BML Handle counterclockwiseto unlock the Button.

3. Firmly press the Button on the BML Handle andremove the Basket Wire.

4. Straighten the Insertion Portions of the Coil Sheathand the Tube Sheath. While holding the Basket Tip,withdraw the Basket Wire from the Tube Sheath.

5. Loosen the Fixing Screw on the Coil Sheath andwithdraw the Tube Sheath from the Coil Sheath.

Disposal of Used Basket Wire

� After use, dispose of the Basket Wirein an appropriate manner. If it is notproperly disposed of, it could pose aninfection control risk.

� Do not reuse the Basket Wire.Reusing the Basket Wire could posean infection control risk, cause tissueirritation or malfunction.

After using the Basket Wire, dispose of it in an appropriatemanner.

Chapter 4 Emergency Treatment



4.1 Emergency Treatment

If lithotripsy can no longer be performed, follow theprocedures described in this Chapter. If there is littleresistance from the BML Handle’s Rotatable Knob, theinstrument may be damaged and lithotripsy may not bepossible.

If the calculus is too hard and theLithotriptor is damaged as described onpages 46 – 51, it may be necessary to usethe BML-110A-1. In this case, also referto the instruction manual for theBML-110A-1.

1. Loosen the Clamping Screw on the BML Handle byturning it counterclockwise, and remove the CoilSheath and Tube Sheath.

2. Turn the Screw on the BML Handle counterclockwiseto unlock the Button.

3. Firmly press the Button on the BML Handle, andremove the Basket Wire.

4. Perform the appropriate treatment given on the chartson Pages 46 through 51.



� When the Pipe is Fractured.

fractured here.

Cut

When the Pipe is fractured.

fractured here.

When the Pipe canbe moved.

When the Pipe cannotbe moved.

Move the Basket back and forthto release the calculus.

Cut the Coil Sheath, TubeSheath and Basket Wireusing pliers or wire cutters.



Remove the instrumentfrom the endoscope.

Cut.

Withdraw the endoscope.

When the calculuscan be released.

When the calculuscannot be released.


Dispose of the BasketWire and carefully inspectthe Coil Sheath and TubeSheath.

Withdraw the Coil Sheath,Tube Sheath andendoscope together.

Use theOlympus’slithotriptorBML-110A-1 orcarry out opensurgery orother possibletreatment.

A certain amount of force issometimes required to withdrawthe endoscope.

Carry out opensurgery or otherpossible treatment.

When the Coil Sheath andTube Sheath can be moved.

Withdraw the CoilSheath and TubeSheath.

When the Coil Sheath and TubeSheath cannot be moved.




� When the Pipe is not Fractured.

When the Pipe is not fractured.

All four wires on the Basket havebroken and the Basket Tip hasbecome separated.

Some of the wires on the Baskethave been broken.

The calculus is not inside theBasket and the instrument is notbroken.



After retracting the Basket Wireinto the Tube Sheath, withdrawthe instrument.

Carry out open surgery or otherpossible treatment.

Retract the Basket Wire into the Tube Sheath, then retract Tube Sheath into theendoscope. Then withdraw the endoscope and instrument together.

Withdraw the instrument.

Dispose of the BasketWire and carefullyinspect the Coil Sheathand Tube Sheath.

If the broken wires of the Basket Wire cannot be retracted intothe Tube Sheath, do not withdraw the instrument and endoscopewith excessive force. This could cause patient injury, such aspunctures, hemorrhages or mucous membrane damage.

WARNING

WARNING

Do not withdraw theinstrument or its fall-offsof the instrument fromthe bile duct withexcessive force. Thiscould cause punctures,hemorrhages, mucousmembrane damage oredema.



� When the Pipe Does not Extend From theProximal End of the Tube Sheath.

Cut

When the Pipe does not extendfrom the proximal end of the TubeSheath.

When the Coil Sheathcan be moved forwardor back with respect tothe endoscope.

When the Coil Sheathcannot be moved forwardor back with respect tothe endoscope.


Withdraw the Coil Sheath, TubeSheath and endoscope together.



Withdraw the endoscope.

A certain amount of force issometimes required to withdrawthe endoscope.


Carry out opensurgery or otherpossible treatment.

When the Coil Sheath andTube Sheath can be moved.

Withdraw the CoilSheath and TubeSheath.

When the Coil Sheath and TubeSheath cannot be moved.




� When to use the BML-110A-1

� Before use, thoroughly review themethod of use for lithotriptorBML-110A-1 in accordance with theinstruction manuals.

� Do not use this lithotriptor BML-110A-1for a calculus that is assumedimpossible to be crushed by thislithotriptor. The basket wire etc. maybreak and part of this lithotriptor mayremain in the body.

� Use this instrument by having thesettings to switch to open surgery andthe hospitalization plan ready in casethe calculus cannot be crushed bylithotriptor BML-110A-1.

� Operation of Mechanical LithotriptorBML-110A-1 is based on theassumption that open surgery ispossible as an emergency measure.If the calculus is too hard and theBasket Wire or Mechanical Lithotriptoris damaged, lithotripsy cannot becontinued. Use the BML-110A-1 withthe understanding that its couldbecome damaged Basket Wire andthat open surgery may have to takeplace.



If the calculus is too hard, it is possible that the damagesshown below (See Figures 4.1, 4.2 and 4.3) and otherdamages may occur. In addition, before usingBML-110A-1, thoroughly review the manual ofBML-110A-1 and use the instruments as instructed.

The Operation Wire is Cut

Figure 4.1



All of the Basket Wires are Cut

Figure 4.2

Some of the Basket Wires are Cut

Figure 4.3

Chapter 5 Reprocessing



� The Coil Sheath, the Tube Sheath andthe BML Handle were not sterilizedbefore shipment. Before using the CoilSheath, the Tube Sheath and the BMLHandle for the first time, reprocessthem according to the instructions inthis Chapter.Do not use the BML Handle that hasnot been cleaned and sterilized. Thisposes an infection control risk and/orcan cause tissue irritation.

� The Basket Wire is single-use,disposable item that is not to bereprocessed. Do not reuse or attemptto sterilize it after use. This could posean infection control risk and/or causetissue irritation.

5.1 General Policy

� The medical literature reports incidents of patientcross contamination resulting from impropercleaning or sterilization. It is stronglyrecommended that reprocessing personnel havea thorough understanding of and follow all nationaland local hospital guidelines and policies.A specific individual or individuals in theendoscopy unit should be responsible forreprocessing endoscopic equipment. It is highlydesirable that a trained backup be available shouldthe primary reprocessing individual(s) be absent.

� All individuals responsible for reprocessing shouldthoroughly understand:



� your institution’s reprocessingprocedures

� occupational health and safetyregulations

� all national and local hospitalguidelines and policies

� the instructions in this manual

� the mechanical aspects of endoscopicequipment

� pertinent germicide labeling

� Failure to properly clean and sterilizethe Coil Sheath, the Tube Sheath andthe BML Handle after eachexamination can compromise patientsafety. During use, the instrumentnormally comes in contact with intactmucous membranes. To minimize therisk of transmitting diseases from onepatient to another, after eachexamination the instrument and theBML Handle must undergo thoroughcleaning followed by sterilization.

� If the Coil Sheath, the Tube Sheath orthe BML Handle is not cleanedmeticulously, effective sterilizationcannot be obtained. Clean the CoilSheath, the Tube Sheath and the BMLHandle thoroughly before sterilizationto remove microorganisms or organicmaterial which can limit theeffectiveness of the sterilizationprocess.



� Patient debris and reprocessingchemicals are hazardous. Wearpersonal protective equipment toguard against dangerous chemicalsand infectious material. Duringcleaning and sterilization, always wearappropriate personal protectiveequipment, such as eye wear, a facemask, moisture-resistant clothing andchemical-resistant gloves that fitproperly and are long enough so thatyour skin is not exposed. Alwaysremove contaminated protectiveclothing before leaving thereprocessing area.

� The reprocessing proceduresdescribed in this manual should becompleted the same day the CoilSheath, the Tube Sheath and the BMLHandle have been used. Ifreprocessing is delayed, residualorganic debris will solidify and it maybe difficult to effectively reprocess theCoil Sheath, the Tube Sheath and/orthe BML Handle.

� With the cleaning and sterilizationmethods stated in this instructionmanual, prions, which are consideredto be the pathogenic substance of theCreutzfeldt-Jakob disease (CJD)cannot be destroyed or inactivated.When using this instrument on apatient with CJD or variantCreutzfeldt-Jakob disease (vCJD), besure to use this product for suchpatient only and/or immediatelydispose of this product after use in anappropriate manner. For methods tohandle CJD, please follow therespective guidelines in your country.



� This instrument is not durable, or doesnot have sufficient durability againstthe respective methods stated in theguidelines of each country fordestroying or inactivating prions. Forinformation on the durability againsteach method, please contactOlympus. If cleaning and sterilizationmethods not stated in this instructionmanual are performed, Olympuscannot guarantee the effectiveness,safety and durability of this instrument.Make sure to confirm that there is noabnormality before use, and use underresponsibility of a physician. Do notuse if any abnormality is found.

NOTE Olympus Endo-Therapy Accessories arecompatible with 2.0% to 3.2%glutaraldehyde solutions. However,routine biological monitoring is notfeasible with glutaraldehyde and,therefore, it should not be used to sterilizereusable medical devices that arecompatible with other methods ofsterilization that can be biologicallymonitored, such as steam sterilization.



5.2 Required Reprocessing Equipment

Wear the personal protective equipment as specified in theTable on page 59.

1. Prepare the following equipment. The requiredamount of detergent solution, lubricant and otherequipment depends on the number of Coil Sheaths,Tube Sheaths and BML Handles to be reprocessed.

2. Fill an immersion basin with detergent solution and filla second immersion basin with lubricant at thetemperatures and concentration recommended bythe manufacturer. Also fill the ultrasonic cleaner witha detergent solution appropriate for ultrasoniccleaning.

Equipment Needed for Reprocessing

To perform proper reprocessing, the equipment in thefollowing table is required. For details on preparation anddirections for use of the following equipment, refer to therespective instruction manuals or contact the equipmentmanufacturer.

Contact Olympus for the names of specific brands ofdetergent solutions and lubricants.

Equipment Needed

Protective Equipment

Appropriate personal protective equipmentmay include: eye wear, face mask,moisture-resistant clothing andchemical-resistant gloves.

Immersion Basinfor DetergentSolution

Use a basin with a depth and diameter largeenough to allow complete immersion of theinstrument when the Insertion Portion is coiledwith a diameter of not less than 15 cm.



Detergent Solutionfor Immersion

Use a neutral pH, low-foaming, medical-gradedetergent solution.

10 cm3 (10 ml)syringe

Ultrasonic Cleaner Use a medical-grade ultrasonic cleaner with afrequency range of 38 to 47 kHz, and with adepth and a diameter large enough to allowcomplete immersion of the instrument whenthe Insertion Portion is coiled with a diameterof not less than 15 cm.Compatible ultrasonic cleaner includesOLYMPUS ULTRASONIC CLEANER KS-2.

Detergent Solutionfor UltrasonicCleaning

Use a neutral pH, low-foaming, medical-gradedetergent solution with no abrasive.

Immersion Basinfor Lubricant

Use a basin with a depth and diameter largeenough to allow complete immersion of theinstrument when the Insertion Portion is coiledwith a diameter of not less than 15 cm.

Lubricant Use a medical-grade, water soluble orlow-viscosity emulsion type lubricant. A highviscosity lubricant will be difficult to inject intothe Port.

Lint-free Cloths

Packages forSteam Sterilization

Use packages compatible with steamsterilization (autoclaving). The packagesshould be large enough to accommodate theinstrument when the Insertion Portion is coiledwith a diameter of not less than 15 cm.The packages should be large enough tocontain the BML Handle.

Sealing Device forSterile Packages

Sealing the packages may require a devicesuch as a heat sealer. Prepare an appropriatesealing device according to the packages tobe used.

Autoclave Use an autoclave that will operate at theconditions specified in Section 5.6,“Sterilization”



5.3 Cleaning

When cleaning, avoid exposure to thefluids discharged from the InsertionPortion and reprocessing chemicals.They may pose an infection control risk orcause skin irritation.

� When reprocessing, do not coil theInsertion Portion with a diameter ofless than 15 cm. This could damagethe Insertion Portion.

� Never use excessive force to open orclose the Coil Sheath, the TubeSheath or the BML Handle. This coulddamaged the Coil Sheath, the TubeSheath and/or BML Handle.

Immersion

� Do not withdraw the Tube Sheath fromthe Coil Sheath quickly. This couldscatter blood, mucous or other patientdebris and pose an infection controlrisk.

� Immerse the Coil Sheath, the TubeSheath and the BML Handle indetergent solution immediately afteruse. If the Coil Sheath, the TubeSheath or the BML Handle is notcleaned immediately, it may be difficultto effectively reprocess, and this couldresult in reduced performance.



1. Immerse the Insertion Portion of the Tube Sheath inthe detergent solution.

2. Connect a 10 cm3 (10 ml) syringe filled with detergentsolution to the Port.

3. Cover the Stopper’s opening with your finger andInject 10 cm3 (10 ml) of detergent solution into theInsertion Portion. (See Figure 5.1)If it is not possible to inject the detergent solution orif it leaks from any areas other than the distal end ofthe Insertion Portion, do not use the Tube Sheath.

4. Disconnect the syringe from the Port.

Stopper

Figure 5.1



5. Fully immerse the BML Handle in the detergentsolution. Make sure that the Rotatable Knob is facingup. (See Figure 5.2)

6. Immerse the entire the Coil Sheath, the Tube Sheathand the BML Handle in the detergent solution for thetime specified in manufacturer’s instructions. If notime is specified, immerse for between 5 minutes and3 hours.

BML Handle

Rotatable Knob

Figure 5.2

7. Remove the Coil Sheath, the Tube Sheath and theBML Handle from the detergent solution.



8. Put the Holder of the BML Handle downwards, anddischarge the remaining detergent solution from theOutlet. Then, push and pull the Holder two or threetimes. (See Figure 5.3)

HolderOutlet

BML Handle

Figure 5.3



Ultrasonic Cleaning

1. Immerse the distal end of the Tube Sheath in theultrasonic cleaner containing detergent solution.

2. Connect a 10 cm3 (10 ml) syringe filled with detergentsolution to the Port.

3. Cover the Stopper’s opening with your finger andInject 10 cm3 (10 ml) of detergent solution into theInsertion Portion. If it is not possible to inject thedetergent solution or if it leaks from any area otherthan the distal end of the Tube Sheath, do not use theTube Sheath.

NOTE Even if the same type of detergentsolution is used for both immersion andultrasonic cleaning, make sure to injectdetergent solution at this time. Replacingthe detergent solution inside the InsertionPortion will increase the effectiveness ofcleaning.


5. Immerse the entire Coil Sheath, Tube Sheath andBML Handle in the detergent solution. Make sure theRotatable knob is forcing up. (See Figure 5.2)

6. Clean ultrasonically for 30 minutes. For details onoperation of the ultrasonic cleaner, refer to theinstruction manual of the ultrasonic cleaner.

7. Remove the Coil Sheath, the Tube Sheath and theBML Handle from the detergent solution.

8. Put the Holder of the BML Handle downwards, anddischarge the remaining detergent solution from theOutlet. Then, push and pull the Holder two or threetimes. (See Figure 5.3)



Rinsing

� After ultrasonic cleaning, rinse the CoilSheath, the Tube Sheath and the BMLHandle thoroughly to remove residualdetergent. Residual detergentsolution could cause tissue irritation inthe next patient.

� Do not forcefully squeeze, wipe orscrub the Coil Sheath, the TubeSheath and the BML Handle. Thiscould cause damage to the CoilSheath, the Tube Sheath and/or theBML Handle result in reducedperformance.

1. Connect a 10 cm3 (10 ml) syringe filled with clean tapwater to the Port.

2. Cover the Stopper’s opening with your finger andInject 10 cm3 (10 ml) of water into the Tube Sheath.If it is not possible to inject water or if it leaks from anyarea other than the distal end of the Tube Sheath, donot use the Tube Sheath.


4. Repeat Steps 1. through 3. to inject a total of 20 cm3

(20 ml) of water into the Tube Sheath.

5. Rinse the Coil Sheath, the Tube Sheath and the BMLHandle under clean running tap water.

6. Push and pull the Holder two or three times underclean running tap water.

7. Confirm that no debris is left on the surfaces of the CoilSheath, the Tube Sheath.

8. Push and pull the Holder and confirm that no debrisremains on the other surface of the BML Handle.

9. Connect a 10 cm3 (10 ml) syringe filled with air to thePort.



10. Cover the Stopper’s opening with your finger andInject 10 cm3 (10 ml) of air into the Tube Sheath.


12. Repeat Steps 9. through 11. until no liquid comes outof the distal end of the Tube Sheath.

13. Wipe the exterior of the Coil Sheath, the Tube Sheathand the BML Handle with a clean, dry lint-free cloth.

5.4 Lubrication

When lubricating, avoid exposure to thefluids discharged from the InsertionPortion and lubricant. It may pose aninfection control risk and/or cause skinirritation.

Do not coil the Insertion Portion with adiameter of less than 15 cm. This coulddamage the Insertion Portion.

1. Immerse the entire Coil Sheath and the BML Handlein the lubricant for 2 to 3 seconds.

2. Connect a 10 cm3 (10 ml) syringe filled with lubricantto the Port.

3. Cover the Stopper’s opening with your finger andinject the lubricant until it comes out of the distal end.If it is not possible to inject the lubricant or it leaks fromany area other than the distal end of the Tube Sheath,do not use the Tube Sheath.


5. Connect a 10 cm3 (10 ml) syringe filled with air to thePort.

6. Cover the Stopper’s opening with your finger andinject 10 cm3 (10 ml) of air into the Tube Sheath once.




8. Repeat steps 5. through 7. until no lubricant comesout of the distal end of the Tube Sheath.

9. Loosen the Knob on the Slide Region of the CoilSheath. Then move the Knob back and forth to slidethe Slide Region a few times.

10. Remove the BML Handle from the lubricant. Put theHolder of the BML Handle downwards, and dischargethe remaining lubricant from the Outlet. Then, pushand pull the Holder two or three times.(See Figure 5.3)

11. Wipe the exterior of the Coil Sheath, the Tube Sheathand the BML Handle with a clean, dry lint-free clothand allow them to air dry.



5.5 Assembly

Inspection Before Assembly

Be sure to inspect the Coil Sheath and theTube Sheath before assembly. Neverattempt to use the instrument if yoususpect that the Coil Sheath and the TubeSheath has an irregularity or is damaged.If an instrument in this condition is used,it may malfunction or cause patient injury,such as punctures, hemorrhages ormucous membrane damage. Equipmentdamage and performance deteriorationmay also result.

To avoid damaging the Coil Sheath, theTube Sheath or the BML Handle, do notuse excessive force when handling them.

Inspect the instrument and the BML Handle according tothe following procedure. If an abnormality is detected, donot use the instrument or the BML Handle. Use a spareinstead.

1. Confirm that the Coil Sheath and Tube Sheath arefree from disconnection or looseness.

2. Gently run your fingertips over the entire length of theCoil Sheath and Tube Sheath to check for anycrushed areas, excessive bends, etc..

3. Gently run your fingertips over the entire length of theTube Sheath to check for broken areas, etc..



Assembly

� Do not use excessive force whenassembling the Coil Sheath and theTube Sheath. This could damage theCoil Sheath and the Tube Sheath.

� Be sure to keep the Coil Sheath andTube Sheath straight whenassembling the Coil Sheath and theTube Sheath. If the Coil Sheath orTube Sheath is not straight, the CoilSheath and the Tube Sheath could bedamaged.

1. Loosen the Knob on the Coil Sheath and slide it as faras possible toward the proximal end. Then tighten theKnob to fix the position of the Slide Region.(See Figure 5.4)

Knob

Coil Sheath

Figure 5.4

2. Straighten the Coil Sheath.



3. Insert the Tube Sheath into the proximal end of theCoil Sheath as shown in Figure 5.5.

Tube Sheath

Coil Sheath

Figure 5.5

NOTE � The Tube Sheath may get caughtinside the Coil Sheath when it isinserted. If this happens, do not try toinsert the Tube Sheath forcibly.Instead, pull or turn the Tube Sheathgently to make it easier to insert.

� The connection of the Guide Pipe andthe Tube of the Tube Sheath is veryfragile. Use extra care when handlingit.



4. Align the guide pin of the Tube Sheath with the Notchat the proximal end of the Coil Sheath as shown inFigure 5.6. Tighten the Fixing Screw to secure them.

Coil Sheath

Guide Pin

Notch

Tube Sheath

Fixing Screw

Guide Pipe

Figure 5.6

5. Make sure that the Tube Sheath is extended from thedistal end of the Coil Sheath.



5.6 Sterilization

Sealing the Package

� Do not coil the Coil Sheath, the TubeSheath with a diameter of less than 15cm. This could damage theinstrument.

� Seal the Coil Sheath, the Tube Sheathand the BML Handle in separatepackages. Otherwise, they could bedamaged.

1. Before sterilization, the Coil Sheath, the Tube Sheathand the BML Handle must be thoroughly cleaned anddried. Residual moisture inhibits sterilization.

2. Coil the Coil Sheath, the Tube Sheath and place it inthe package.

3. Place the BML Handle in a separate package.

4. Seal the packages. For details on sealing, refer to theinstruction manual of the packages and the sealingdevice.

Steam Sterilization (Autoclaving)

� Use biological indicators asrecommended by your hospital’spolicy and follow the manufacturer’sinstructions, all national and localhospital guidelines and policies.

� Always leave space between thepackages in the autoclave. If thepackages are placed too closetogether, effective sterilization will notbe possible.



� Allow the sterile packages to dry withinthe autoclave using the autoclave’sdrying cycle (if applicable) or byopening the door of the autoclave andallowing the packages to air dry.Handling a wet package cancompromise its sterility.

� The results of sterilization depend onvarious factors such as how thesterilized instrument was packed orthe positioning, method of placing andloading of the instrument in thesterilization device. Please verify thesterilization effects by using biologicalor chemical indicators. Also follow theguidelines for sterilization issued bymedical administrative authorities,public organizations or the infectionmanagement sections at eachmedical facility, as well as theinstruction manual of the sterilizationdevice.

1. Place the sealed packages containing the CoilSheath, the Tube Sheath and the BML Handle in theautoclave and sterilize in accordance with theconditions listed below. For details on operation of theautoclave, refer to the instruction manual for theautoclave or other manufacturer instructions.

2. After steam sterilization, let the Coil Sheath, the TubeSheath and the BML Handle gradually cool down toroom temperature. Sudden changes in temperaturemay damage the Coil Sheath, the Tube Sheath and/orthe BML Handle.



NOTE Autoclavable products have a greenreference label. Products that do nothave green reference labels are notautoclavable.

Temperature Exposure Time

Prevacuum 132 to 134°C(270 to 274°F)

5 minutes

Table 5.1 Recommended Steam Sterilization

(Autoclaving) Conditions

Chapter 6 Storage


Chapter 6 Storage

� Do not store the Coil Sheath, the TubeSheath or BML Handle in a sterilepackage that is damaged, wet orimproperly sealed. Otherwise, thesterility of the Coil Sheath, the TubeSheath or BML Handle may becompromised and pose an infectioncontrol risk and/or cause tissueirritation.

� Do not store sterile packagescontaining the Coil Sheath, the TubeSheath or BML Handle in place wherethey will be damaged, wet orimproperly sealed. Otherwise, thesterility of the Coil Sheath, the TubeSheath or BML Handle may becompromised and pose an infectioncontrol risk and/or cause tissueirritation.

Do not coil the Coil Sheath, the TubeSheath with a diameter of less than 15 cm.This could damage the instrument.

Chapter 6 Storage


6.1 Inspection Before Storage

Prior to storage, inspect the sterile packages as follows:

1. Confirm that the sterile package containing theBasket Wire is free from tears, inadequate sealing orwater damage. If tears, inadequate sealing or waterdamage is detected, do not use the instrument;contact Olympus.

2. Confirm that the sterile packages containing the CoilSheath, the Tube Sheath and the BML Handle arefree from tears, inadequate sealing or water damage.If tears, inadequate sealing or water damage isdetected, repackage and sterilize again as describedin Section 5.6, “Sterilization”.

6.2 Storage

Store the instrument and the BML Handle in the sterilepackages at room temperature in a clean and dryenvironment. Do not store it in direct sunlight. Ensure thatthe packaged instrument and the BML Handle are notcrushed by surrounding objects during storage. Followany additional storage instruction provided by themanufacturer of the sterile package.

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1997 OLYMPUS MEDICAL SYSTEMS CORP. All rights reserved.No part of this publication may be reproduced or distributed without theexpress written permission of OLYMPUS MEDICAL SYSTEMS CORP.

OLYMPUS is a registered trademark of OLYMPUS CORPORATION.

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