Olympus BML-110A-1 User manual

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
Contents
Chapter 6 Storage .............................................. 44
6.1 Inspection Before Storage ........................................ 44
6.2 Storage ..................................................................... 45
ii
MECHANICAL LITHOTRIPTOR BML-110A-1
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.
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 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 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
2.1 Nomenclature 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.
2.2 Specifications
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 Temperature 10 – 40°C (50 – 104°F)
Relative Humidity 30 – 85%
Air Pressure 700 – 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 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.
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
Loading...
+ 36 hidden pages