Olympus BML-3Q14Q-1 User manual
INSTRUCTIONS
MECHANICAL LITHOTRIPTOR
BML-3Q-1
BML-4Q-1
USA: CAUTION: Federal law restricts this device to sale by or on the
order of a physician.
0197
Contents
Symbols
Important Information–Please Read Before Use
Intended 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 Contents
1.1 Checking the Package Contents 6. . . . . . . . . . . . . . . .
Chapter 2 Instrument
Nomenclature and Specifications
2.1 Nomenclature and Functions 8. . . . . . . . . . . . . . . . . . .
2.2 Specifications 14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contents
Chapter 3 Preparation,
Inspection and Operation
3.1 Preparation 19. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.2 Inspection 20. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3 Operation 31. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 4 Emergency Treatment
4.1 Emergency Treatment 45. . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 5 Reprocessing
5.1 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
iMECHANICAL LITHOTRIPTOR
Contents
Chapter 6 Storage
6.1 Inspection Before Storage 77. . . . . . . . . . . . . . . . . . . . . .
6.2 Storage 77. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ii MECHANICAL LITHOTRIPTOR
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
STERILE LOT
LOT
Sterilized using ethylene oxide
Sterilization lot number
Lot number
Manufacturer
Authorised representative in the
European Community
1MECHANICAL LITHOTRIPTOR
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.
3MECHANICAL LITHOTRIPTOR
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.
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.
4 MECHANICAL LITHOTRIPTOR
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.
5MECHANICAL LITHOTRIPTOR
Chapter 1 Checking the Package Contents
Chapter 1 Checking the Package
Contents
1.1 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)
Basket Wire (Sterile, Single use only)
6 MECHANICAL LITHOTRIPTOR
BML Handle (MAJ-440, Reusable)
Instruction Manual
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)
7MECHANICAL LITHOTRIPTOR
Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument
Nomenclature and
Specifications
2.1 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
2. Identification Mark
1. Model Reference
Label
Lot Number
Insertion Portion/Working Length
8 MECHANICAL LITHOTRIPTOR
Slide Region
6. Port
5. Guide Pin
Guide Pipe
Chapter 2 Instrument Nomenclature and Specifications
` Tube Sheath (Reusable)
7. Stopper
1. Model Reference Label
2. Identification Mark
8. Tube
9MECHANICAL LITHOTRIPTOR
Chapter 2 Instrument Nomenclature and Specifications
` Basket Wire (Sterile, Single use only)
9. Wire Joint
Lot Number
2. Identification Mark
Pipe
Protective Tube
Basket Tip
Basket
Protective Tube
Wire
10 MECHANICAL LITHOTRIPTOR
` BML Handle (MAJ-440, Reusable)
15. Insertion Hole
14. Outlet
13. Rotatable Knob
12. Screw
11. Button
Chapter 2 Instrument Nomenclature and Specifications
Lot Number
16. Clamping Screw
Grip
10. Checking Window
Rack
17. Holder
Button Unlocked
14. Outlet
11. Button
12. Screw
Button Locked
11MECHANICAL LITHOTRIPTOR
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
Coil Sheath
Side Region
4 black stripes
Guide Pipe
3 black stripes
Tube Sheath
Pipe
3 black stripes
Basket Wire
Guide Pipe
4 black stripes
Pipe
4 black stripes
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.
13MECHANICAL LITHOTRIPTOR
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/cm
(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.
14 MECHANICAL LITHOTRIPTOR
2
)
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
Shape of the
Grasping Basket
Maximum Insertion
Portion Diameter (mm)
Working Length (mm) 1950
Opening Length (mm) 30
Model
and
Compatible
Olympus
Endoscopes
(All of the parameters
should be met.)
Compatible
Olympus Handle
Compatible
Olympus
Lithotriptor for
Emergency Use
Length
Channel
Inner
Diameter
(mm)
(Color
Code)
ø 3.7 ø 2.9
Working
Length less
than 1400
mm;
TJF
ø 4.2
(Orange);
ø 5.5
(Pink)
BML Handle: MAJ-440
BML-110A-1
Working
Length less
than 1400
mm;
JF, TJF
ø 3.2
(Yellow);
ø 4.2
(Orange);
ø 5.5
(Pink)
15MECHANICAL LITHOTRIPTOR
Chapter 2 Instrument Nomenclature and Specifications
Medical Device
Directive
This device complies with the
requirements of Directive
93/42/EEC concerning medical
0197
devices.
Classification: Class I
16 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.
17MECHANICAL LITHOTRIPTOR
Chapter 3 Preparation, Inspection and Operation
S Before each case, prepare and inspect
the instrument and the BML Handle as
instructed below. Inspect other
equipment to be used with the
instrument and the BML Handle as
instructed in their respective
instruction manuals.
Should the slightest irregularity be
suspected, do not use the instrument
or the BML Handle; contact Olympus.
Damage or irregularity may
compromise patient or user safety,
since it may pose an infection control
risk, cause tissue irritation, punctures,
hemorrhages or mucous membrane
damage. It may also result in more
severe equipment damage.
S 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 and
assemble them according to the
instructions in Chapter 5,
“Reprocessing”.
Do not use an instrument or the BML
Handle that has not been cleaned and
sterilized. This could pose an infection
control risk and/or can cause tissue
irritation.
S Do not coil the Insertion Portion with a
diameter of less than 15 cm. This
could damage the Insertion Portion.
S Never use excessive force to operate
the instrument and the BML Handle.
This could damage the instrument
and/or the BML Handle.
18 MECHANICAL LITHOTRIPTOR
3.1 Preparation
Equipment and Personal Protective Equipment
Prepare all equipment and personal protective equipment
which will be used with the instrument and BML 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 and BML Handle
Always have a spare instrument and BML Handle
available.
Sterilized Syringe and Contrast Medium for
Inspection
Chapter 3 Preparation, Inspection and Operation
Prepare a sterile syringe and contrast medium for
inspection.
Reprocessing Equipment
Prepare reprocessing equipment as described in Section
5.2, “Required Reprocessing Equipment” for immediate
reprocessing after use.
19MECHANICAL LITHOTRIPTOR
Chapter 3 Preparation, Inspection and Operation
Equipment to be Used in Emergency
Always have pliers ready to cut the Coil Sheath, Tube
Sheath and/or Basket Wire in case lithotripsy cannot be
performed. Also have the Olympus Lithotriptor
BML-110A-1 ready.
3.2 Inspection
Wear the personal protective equipment as specified in the
Table on page 59.
Before each case, always inspect the instrument and the
BML Handle according to the following procedures.
If an abnormality in the instrument or the BML Handle is
detected, use a spare instrument or BML 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 the
BML Handle may have been compromised. Use a spare
instead.
Appearance Inspection
If any of following steps reveals irregularities, do not use
the instrument or the BML Handle; use a spare instead.
Before use, carefully inspect the entire
coil sheath as instructed in this chapter;
confirm that it is not crushed, bent,
deformed or otherwise damaged. A
damaged coil sheath may not be able to
properly crush a calculus and/or it could
cause the instrument to break.
20 MECHANICAL LITHOTRIPTOR
Chapter 3 Preparation, Inspection and Operation
` Inspecting the Instrument
Be sure to inspect the Coil Sheath before
assembly. Never attempt to use the
instrument if you suspect that the Coil
Sheath 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 or
mucous membrane damage. Equipment
damage and performance deterioration
may also result.
When pulling the Basket Wire out of the
Protective Tube, take care not to bend the
Pipe of the Basket Wire. This could
damage the Basket Wire.
1. Straighten the Protective Tube containing the Basket
Wire. Then, hold the Basket Tip and withdraw the
Basket Wire all the way. Dispose of the Protective
Tube. (See Figure 3.1)
Protective Tube
Figure 3.1
Basket Tip
Basket
21MECHANICAL LITHOTRIPTOR
Chapter 3 Preparation, Inspection and Operation
NOTE
Do not withdraw the Basket Wire forcibly
if the Wire Joint catches on the Protective
Tube. Use your fingers to gently extricate
the part of the Basket Wire that is caught
and then withdraw it.
2. Confirm that the Coil Sheath, Tube Sheath and
Basket Wire are free from disconnection or
looseness.
3. Gently run your fingertips over the entire length of the
Coil Sheath and Tube Sheath to check for any
crushed areas, excessive bends, etc..
4. Confirm that there is no unraveled, disconnected or
broken wires, sharp protrusions, sharp edges or any
other apparent abnormalities of the Basket Wire.
` Inspecting the BML Handle
Make sure that there are no cracks on the BML Handle.
Assembling and Inspection
S Do not use excessive force when
assembling the instrument. This could
damage the instrument.
S Be sure to keep the Coil Sheath and
Tube Sheath straight when
assembling the instrument. If the Coil
Sheath or Tube Sheath is not straight,
the instrument could be damaged.
S Move the Basket Wire’s Pipe back and
forth slowly. Fast or abrupt movement
could damage the Pipe.
1. Straighten the Tube Sheath.
2. Insert the Basket Wire into the proximal end of the
Tube Sheath as shown in Figure 3.2.
22 MECHANICAL LITHOTRIPTOR
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