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
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
3
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
4
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.
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
5
Chapter 1 Checking the Package Contents
Chapter 1Checking 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 2Instrument
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
7
Chapter 2 Instrument Nomenclature and Specifications
Handle
Center Rod
5. Wire Insertion Hole
Grip
4. Clamping Screw
3. Sheath Insertion Hole
Ratchet Wheel
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
9
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.
•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.
Operating Environment
10
Ambient Temperature10 – 40°C (50 – 104°F)
Relative Humidity30 – 85%
Air Pressure700 – 1060 hPa
Specifications
Model
Shape of the Distal End
Maximum Insertion
Portion Diameter (mm)
MECHANICAL LITHOTRIPTOR BML-110A-1
(0.71 – 1.08 kgf/cm
(10.1 – 15.4 psia)
-110A-1
BML
ø3.9
2
)
Chapter 2 Instrument Nomenclature and Specifications
Working Length (mm)900
Compatible Olympus Basket Type
Grasping Forceps and
Mechanical Lithotriptors
FG-22Q-1, FG-23Q-1,
FG-301Q, FG-401Q,
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
Directive
This device complies with the
requirements of Directive
93/42/EEC concerning
medical devices.
Classification: Class I
MECHANICAL LITHOTRIPTOR BML-110A-1
11
Chapter 3 Preparation, Inspection and Operation
Chapter 3Preparation,
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.
12
•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.
MECHANICAL LITHOTRIPTOR BML-110A-1
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