Instructions
52 Pages
Preview
Page 1
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 ... Instruction Manual ... User Qualifications... Instrument Compatibility ... Reprocessing and Storage ... Repair and Modification ... Signal Words ... Warnings...
Chapter 1 1.1
Checking the Package Contents...
6
Checking the Package Contents ...
6
Chapter 2 2.1 2.2
Instrument Nomenclature and Specifications ...
7
Nomenclature and Functions... Specifications...
7 9
Chapter 3 3.1 3.2 3.3
13 13 18
Emergency Treatment... 29
Emergency Treatment ...
Chapter 5 5.1 5.2 5.3 5.4 5.5
Preparation, Inspection and Operation ... 12
Preparation ... Inspection ... Operation ...
Chapter 4 4.1
2 2 2 3 3 3 4 4
29
Reprocessing... 34
General Policy ... Required Reprocessing Equipment ... Cleaning... Lubrication ... Sterilization ...
MECHANICAL LITHOTRIPTOR BML-110A-1
34 37 39 41 42
i
Contents
Chapter 6 6.1 6.2
ii
Storage ... 44
Inspection Before Storage ... Storage ...
MECHANICAL LITHOTRIPTOR BML-110A-1
44 45
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 Follow the warning described below when handling this instrument. This information is to be supplemented by the warnings described in each chapter.
4
•
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 1.1
Checking the Package Contents
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
2.1
Instrument Nomenclature and Specifications
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
4. Clamping Screw
3. Sheath Insertion Hole Center Rod Ratchet Wheel 5. Wire Insertion Hole
Grip 6. Rotatable Bar
7. Ratchet Stopper
8. Model Reference Label Lot Number
8
MECHANICAL LITHOTRIPTOR BML-110A-1
Chapter 2 Instrument Nomenclature and Specifications
1. Stopper Fits into the Handle’s Sheath Insertion Hole to prevent separation of the Coil Sheath from the Handle. 2. Model Reference Label Indicates the product number. A green reference label indicates that the instrument is autoclavable. 3. Sheath Insertion Hole Holds the Stopper of the Coil Sheath to prevent separation of the Coil Sheath from the Handle. 4. Clamping Screw Tightened to fix the Stopper of the Coil Sheath. 5. Wire Insertion Hole Insert the wire here to coil it onto the Center Rod. 6. Rotatable Bar When turned, this coils the wire onto the Center Rod. 7. Ratchet Stopper Engages the Ratchet Wheel to prevent the Center Rod from reversing. 8. Model Reference Label Indicates the product number. A green reference label indicates that the instrument is autoclavable.
2.2
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 Ambient Temperature
10 – 40°C (50 – 104°F)
Relative Humidity
30 – 85%
Air Pressure
700 – 1060 hPa (0.71 – 1.08 kgf/cm2) (10.1 – 15.4 psia)
Specifications Model
BML-110A-1
Shape of the Distal End
Maximum Insertion Portion Diameter (mm)
10
ø 3.9
MECHANICAL LITHOTRIPTOR BML-110A-1
Chapter 2 Instrument Nomenclature and Specifications
Working Length (mm)
900
Compatible Olympus Basket Type
FG-22Q-1, FG-23Q-1,
Grasping Forceps and
FG-301Q, FG-401Q,
Mechanical Lithotriptors
FG-402Q, FG-403Q, FG-V401QR, FG-V402QR, FG-V411Q, FG-V412Q, BML-1Q-1, BML-2Q-1, BML-3Q-1, BML-4Q-1, BML-201Q, BML-202Q, BML-203Q, BML-204Q, BML-V232QR-26, BML-V232QR-30, BML-V237QR-30, BML-V242QR-30, BML-V437QR-30, BML-V442QR-30
Medical Device
This device complies with the
Directive
requirements of Directive 93/42/EEC concerning medical devices. Classification: Class I
MECHANICAL LITHOTRIPTOR BML-110A-1
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.
•
The instrument was not sterilized before shipment. Before using the instrument for the first time, reprocess it according to the instructions in Chapter 5, “Reprocessing”. Do not use an instrument that has not been cleaned and sterilized. This poses an infection control risk and can cause tissue irritation. Do not coil the Insertion Portion with a diameter of less than 15 cm. This could damage the Insertion Portion.
12
MECHANICAL LITHOTRIPTOR BML-110A-1
Chapter 3 Preparation, Inspection and Operation
3.1
Preparation Equipment and Personal Protective Equipment Prepare all equipment and personal protective equipment which will be used with the instrument 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. Also have pliers or wire cutters ready; you will need them to cut the sheath and wire of the Grasping Forceps or Mechanical Lithotriptor.
Spare Instrument Always have a spare instrument available.
Reprocessing Equipment Prepare reprocessing equipment as described in Section 5.2, “Required Reprocessing Equipment” for immediate reprocessing after use.
3.2
Inspection Wear the personal protective equipment as specified in the Table on page 38. Before each case, always inspect the instrument according to the following procedures. If an abnormality in the instrument is detected, use a spare instrument, inspecting it thoroughly before use.
MECHANICAL LITHOTRIPTOR BML-110A-1
13
Chapter 3 Preparation, Inspection and Operation
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 may have been compromised. Use a spare instead.
Appearance Inspection If any of following steps reveals irregularities, do not use the instrument; 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.
Inspecting the Coil Sheath 1. Make sure that the Distal End and Stopper of the Coil Sheath are free from disconnection or looseness.
2. Gently run your fingertips over the entire length of the Insertion Portion to check for any crushed areas, excessive bends, sharp protrusions, sharp edges.
3. Make sure that there are no sharp protrusions, sharp edges or other apparent malformations at the Distal End of the Insertion Portion. Confirm that the Distal End of the Insertion Portion appears exactly as shown in the Table in Section 2.2, “Specifications” and is not damaged.
14
MECHANICAL LITHOTRIPTOR BML-110A-1
Chapter 3 Preparation, Inspection and Operation
Inspecting the Handle 1. Make sure that the Handle’s Sheath Insertion Hole and Wire Insertion Hole are undamaged and free of any foreign matter.
2. Make sure that there are no cracks on the Handle. Inspecting the Connections Make sure to have the stopper and the BML handle connected. If the instrument separates from the BML handle during operation, the pipe may break or become uncontrollable. Also, the coil sheath and wire with calculus engaged may not be removed from the body. Due to this instrument’s construction, the Ratchet Stopper of the Handle has a sharp tip. To avoid injury, be very careful when handling this instrument. If any of following steps reveals irregularities, do not use the instrument; use a spare instead.
1. Loosen the Clamping Screw of the Handle by turning it counterclockwise until it stops.
2. Insert the Coil Sheath’s Stopper as far as possible into the Handle’s Insertion Hole (see Figure 3.1).
3. Tighten the Handle’s Clamping Screw by turning it clockwise until it stops (see Figure 3.1).
4. Push and pull the Stopper to make sure the Stopper is securely attached to the Handle.
5. Loosen the Clamping Screw by turning it counterclockwise until it stops and remove the Coil Sheath. MECHANICAL LITHOTRIPTOR BML-110A-1
15
Chapter 3 Preparation, Inspection and Operation
Coil Sheath Clamping Screw
Sheath Insertion Hole Stopper
Figure 3.1
Inspection of Operation After assembly, check that no abnormality is detected in the action of the handle. If there is any abnormality, the calculus may not be crushed and/or the coil sheath and wire with stone engaged may not be removed from the body. Due to this instrument’s construction, the Ratchet Stopper of the Handle has a sharp tip. To avoid injury, be very careful when handling this instrument. If any of following steps reveals irregularities, do not use the instrument; use a spare instead.
1. To make sure the Rotatable Bar and Center Rod rotate smoothly, turn the Rotatable Bar in the direction of the arrow as shown in Figure 3.2.
16
MECHANICAL LITHOTRIPTOR BML-110A-1
Chapter 3 Preparation, Inspection and Operation
Rotatable Bar
Figure 3.2
2. Push the Ratchet Stopper with your finger. Confirm that it operates smoothly (see Figure 3.3).
Ratchet Stopper
Figure 3.3
3. Engage the Ratchet Stopper. Confirm that the Ratchet Stopper is working properly by attempting to turn the Rotatable Bar in the direction of the arrow as shown in Figure 3.4. The Ratchet Stopper should prevent the Rotatable Bar from being turned in this direction.
MECHANICAL LITHOTRIPTOR BML-110A-1
17