Olympus B5-2 Instructions

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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

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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

DISPOSABLE BALLOON CATHETER

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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.

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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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Chapter 1 Checking the Package Contents

Chapter 1 Checking 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.

Instruction Manual

Balloon Catheter (Sterile, Single use only)

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Olympus B5-2 Instructions

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument

Nomenclature and

Specifications

2.1Nomenclature and Functions

The sterile instrument is sealed in a package.

1. Wire

2. Grip

3. Luer-lock Connector-1

4. Stylet

5. Injection Port

6. Knob

7.Model Reference Label

8. Air Feeding

Port

9. Branch

 

 

Stopcock

 

10. Stopcock

 

Connector

11. Air Volume

 

Label

Distal End

12. Luer-lock

13. Tube

Connector-2

 

 

Insertion Portion

 

/Working Length

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Chapter 2 Instrument Nomenclature and Specifications

Distal End

14. Balloon

15. Lightproof Cap

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.

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