Olympus B5-2 Instructions
INSTRUCTIONS
DISPOSABLE BALLOON CATHETER
B5-2C/2Q/2LA
B7-2C/2Q/2LA
USA: CAUTION:
• This Product Contains Natural Rubber Latex
Which May Cause Allergic Reactions.
• 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............................................................. 3
Instrument Compatibility .................................................... 3
Storage .............................................................................. 3
Repair and Modification ..................................................... 3
Signal Words ..................................................................... 4
Natural Rubber Latex Medical Alert................................... 4
Chapter 1 Checking the Package Contents..... 5
1.1 Checking the Package Contents .............................. 5
Chapter 2 Instrument Nomenclature and
Specifications................................... 6
2.1 Nomenclature and Functions.................................... 6
2.2 Specifications............................................................ 9
Chapter 3 Storage .............................................. 14
3.1 Inspection Before Storage........................................ 14
3.2 Storage ..................................................................... 14
Chapter 4 Preparation, Inspection and
Operation .......................................... 15
4.1 Preparation ............................................................... 16
4.2 Inspection ................................................................. 16
4.3 Operation .................................................................. 21
DISPOSABLE BALLOON CATHETER
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Contents
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DISPOSABLE BALLOON CATHETER
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)
Sterilized using ethylene oxide
Sterilization lot number
Lot number
Compatible with a ø0.53 mm
(0.021 inch) guidewire.
Compatible with a ø0.89 mm
(0.035 inch) guidewire.
Manufacturer
Authorised representative in the
European Community
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Important Information — Please Read Before Use
Important Information — Please
Read Before Use
Intended Use
B5-2C, B7-2C
These instruments have been designed to be used with
Olympus endoscopes to inject contrast medium or other
medical fluid into the bile duct, pancreatic duct, and
respiratory organs. They can also be used for irrigation,
hemostasis within the respiratory organs, and retrieval of
foreign bodies within the bile duct, pancreatic duct and
respiratory organs. Do not use these instruments for any
purpose other than their intended use.
B5-2Q/2LA, B7-2Q/2LA
These instruments have been designed to be used with
Olympus endoscopes to inject contrast media into the
biliary or pancreatic tract. They can also be used for
retrieval of biliary or pancreatic stones. 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.
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DISPOSABLE BALLOON CATHETER
Important Information — Please Read Before Use
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.
Instrument Compatibility
Refer to the Tables 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.
Storage
This instrument was shipped in a sterile condition. Store
it following the instructions in Chapter 3, “Storage”.
Improper storage can present an infection control risk,
cause equipment damage or reduce performance.
This instrument is a single-use, disposable item that is
not to be reprocessed. Do not reuse or attempt to
sterilize.
Repair and Modification
This instrument contains no user-serviceable parts. Do
not disassemble, modify or attempt to repair; patient or
user injury and equipment damage can result.
DISPOSABLE BALLOON CATHETER
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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.
Natural Rubber Latex Medical Alert
This product contains natural rubber latex which may
cause allergic reactions. The balloon at the distal end of
the insertion portion is made of natural rubber latex. Do
not use this product on a latex–sensitive patient.
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DISPOSABLE BALLOON CATHETER
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.
Balloon Catheter
(Sterile, Single use only)
DISPOSABLE BALLOON CATHETER
Instruction Manual
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Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument
Nomenclature and
Specifications
2.1 Nomenclature and Functions
The sterile instrument is sealed in a package.
1. Wire
3. Luer-lock Connector-1
5. Injection Port
7. Model Reference
Label
9. Branch
11. Air Volume
Label
12. Luer-lock
Connector-2
2. Grip
4. Stylet
6. Knob
8. Air Feeding
Port
Stopcock
10. Stopcock
Connector
Distal End
13. Tube
Insertion Portion
/Working Length
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DISPOSABLE BALLOON CATHETER
Chapter 2 Instrument Nomenclature and Specifications
Distal End
14. Balloon
1. Wire
The wire is available with the B7-2C/2Q/2LA only.
Inserted in the tube to prevent the tube from kinking.
2. Grip
The grip is attached to Luer-lock connector-1.
3. Luer-lock Connector-1
The Luer-lock is attached to the grip.
4. Stylet
The stylet is available with the B7-2C/2Q/2LA only
and incorporates the grip and wire.
5. Injection Port
Attach a syringe the injection port to inject contrast
medium, medical fluid or saline.
6. Knob
The knob switches a valve to control the airflow.
When the valve is opened, the balloon can be
inflated. After inflation, the knob is rotated and the
valve is shut, maintaining inflation.
7. Model Reference Label
The model reference label indicates the product
number.
15. Lightproof Cap
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