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

i

Contents

ii

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

1

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.

2

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

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.

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.

4

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

5

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

6

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

DISPOSABLE BALLOON CATHETER

7

Chapter 2 Instrument Nomenclature and Specifications

8. Air Feeding Port

A syringe is mounted on the air feeding port, and air
is injected into the balloon to inflate it.

9. Branch

The color of the branch indicates the minimum
instrument channel diameter required for the
endoscope to be compatible.

10. Stopcock Connector

The stopcock connector is attached to Luer-lock
connector-2 to secure the stopcock.

11. Air Volume Label

Indicates the air volume required for maximum
balloon inflation.

12. Luer-lock Connector-2

The Luer-lock connector is attached to the stopcock
connector.

13. Tube

The tube works as the channel through which air is
fed into the balloon from the air feeding port and as
the channel through which contrast medium,
medical fluid or saline is injected.

14. Balloon

The balloon can be inflated and deflated using the
syringe attached to the air feeding port.

15. Lightproof Cap

The lightproof cap prevents the latex rubber balloon
from deteriorating when transported or stored.

8

DISPOSABLE BALLOON CATHETER

2.2 Specifications

The compatible Olympus endoscopes are listed in the
table on the following page. New endoscopes released
after the introduction of this instrument may also be
compatible for use in combination with this instrument.
For further details, contact Olympus.

Operating Environment

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.

Ambient Temperature

Relative Humidity 30 to 85%

Air Pressure 700 to 1060 hPa

10 to 40

(0.71 to 1.08 kgf/cm
(10.1 to 15.4 psia)

DISPOSABLE BALLOON CATHETER

°C (50 to 104°F)

2

)

9

Chapter 2 Instrument Nomenclature and Specifications

Specifications

The volume of the air in the balloon
should not exceed the parameters
specified in the following tables.
Otherwise, the balloon may burst or may
not deflate. When the balloon does not
deflate, do not operate the balloon
catheter with excessive force. Otherwise,
the distal end of the instrument may
break off and could remain inside the
patient.

Model B5-2C B7-2C

Shape of the
Balloon

10

Maximum
Insertion
Portion
Diameter (mm)

Working Length
(mm)

Diameter after
inflation (mm)

Maximum Air
Vol ume
(ml (cc))

Compatible
Guide Wire
(mm (inch))

ø 1.95 ø 2.55

ø 11.0 ø 13.0

ø 0.53

(0.021)

DISPOSABLE BALLOON CATHETER

1050

1.5 1.7

ø 0.89

(0.035)

Chapter 2 Instrument Nomenclature and Specifications

Compatible
Olympus
Endoscopes

(All of these
parameters
should be met.)

Length and
Model

Channel
Inner
Diameter
(mm)
(Color Code)

Working length less than

600 mm;
CHF, BF

ø 2, ø 2.2
(Blue);
ø2.6
(Green);
ø 2.8, ø 3.2
(Yellow)

ø 2.8, ø 3.2
(Yellow)

The G35-2LB and G35-2LD guidewires
are available from Olympus for use in

combination with the B7-2C.

Medical
Device
Directive

Model B5-2Q B7-2Q

Shape of the
Balloon

This device complies with the
requirements of Directive
93/42/EEC concerning medical
devices. Classification: Class II a

Maximum
Insertion
Portion
Diameter (mm)

Working Length
(mm)

Diameter after
inflation (mm)

DISPOSABLE BALLOON CATHETER

ø1.95 ø2.55

1950

ø11.0 ø13.0

11

Chapter 2 Instrument Nomenclature and Specifications

Maximum Air
Vol ume
(ml (cc))

Compatible
Guide Wire
(mm (inch))

Compatible
Olympus
Endoscopes

(All of these
parameters
should be met.)

The G35-2LB and G35-2LD guidewires
are available from Olympus for use in
combination with the B7-2Q.

Length and
Model

Channel
Inner
Diameter
(mm)
(Color Code)

1.6 1.8

ø 0.53

(0.021)

Working length less than

1400 mm;

ø2.2
(Blue);
ø 2.8, ø 3.2
(Yellow);
ø 3.7, ø 4.2
(Orange);
ø5.5
(Pink)

ø 0.89

(0.035)

JF, TJF

ø 2.8, ø 3.2
(Yellow);
ø 3.7, ø 4.2
(Orange);
ø5.5
(Pink)

12

Model B5-2LA B7-2LA

Shape of the
Balloon

Maximum
Insertion
Portion
Diameter (mm)

Working Length
(mm)

Diameter after
inflation (mm)

ø 1.95 ø 2.55

3500

ø 11.0 ø 13.0

DISPOSABLE BALLOON CATHETER

Maximum Air
Vol ume
(ml (cc))

Compatible
Guide Wire
(mm (inch))

Compatible
Olympus
Endoscopes

(All of these
parameters
should be met.)

Chapter 2 Instrument Nomenclature and Specifications

1.8 2.0

Length and
Model

Channel
Inner
Diameter
(mm)
(Color Code)

ø 0.53

(0.021)

Working length less than

1400 mm;

ø2.2
(Blue);
ø 2.8, ø 3.2
(Yellow);
ø 3.7, ø 4.2
(Orange);
ø5.5
(Pink)

ø 0.89

(0.035)

JF, TJF

ø 2.8, ø 3.2
(Yellow);
ø 3.7, ø 4.2
(Orange);
ø5.5
(Pink)

The G35-2LB and G35-2LD guidewires
are available from Olympus for use in
combination with the B7-2LA.

Medical
Device
Directive

This device complies with the
requirements of Directive
93/42/EEC concerning medical
devices. Classification: Class I

DISPOSABLE BALLOON CATHETER

13

Chapter 3 Storage

Chapter 3 Storage

• Do not store the instrument in a sterile
package that is damaged, wet or
improperly sealed. Otherwise, the
sterility of the instrument may be
compromised and pose an infection
control risk or cause tissue irritation.

• Do not store the sterile package
containing the instrument in place where
it will be damaged, wet or improperly
sealed. Otherwise, the sterility of the
instrument may be compromised and
pose an infection control risk or cause
tissue irritation.

3.1 Inspection Before Storage

Prior to storage, inspect the sterile package as follows:

Confirm that the sterile package containing the
instrument is free from tears, inadequate sealing or water
damage. If tears, inadequate sealing, or water damage is
detected, do not use the instrument; contact Olympus.

3.2 Storage

Store the instrument in the sterile package at room
temperature in a clean and dry environment. Do not store
it in direct sunlight. Ensure that the package is not
crushed by surrounding objects during storage.

14

DISPOSABLE BALLOON CATHETER

Chapter 4 Preparation, Inspection and Operation

Chapter 4 Preparation,

Inspection and
Operation

The instrument was shipped in a sterile condition.

• This product contains natural rubber
latex which may cause allergic reactions.
The balloon at the distal end of the
insertion section is made of natural
rubber latex. Do not use this product on a
latex–sensitive patient.

• Do not use an instrument after the
expiration date displayed on the sterile
package. Doing so may pose an infection
control risk or cause tissue irritation.

• 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.

Do not coil the insertion portion with a
diameter of less than 15 cm. This could
damage the insertion portion.

DISPOSABLE BALLOON CATHETER

15

Chapter 4 Preparation, Inspection and Operation

4.1 Preparation

Equipment and Personal Protective Equipment

Prepare all equipment and personal protective
equipment that 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 that fit properly and are long
enough so that your skin is not exposed.

Spare Instrument

Always have a spare instrument available.

Sterile Syringe, Contrast Medium, Medical Fluid ,

or Saline for Inspection

Prepare a sterile syringe and contrast medium, and
medical fluid or saline solution for inspection.

4.2 Inspection

Wear the personal protective equipment as specified
above.

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.

16

DISPOSABLE BALLOON CATHETER

Chapter 4 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.

1. Remove the lightproof cap from the distal end of the

instrument.

2. Gently run your fingertips over the entire length of

the insertion portion to check for any crushed areas,
excessive bends, broken areas or other damages.

3. Confirm that the distal end of the instrument appears

exactly as shown in the tables in Section 2.2,
“Specifications” and is not damaged.

Making and Inspecting the Connections

If any of following steps reveals irregularities, do not use
the instrument; use a spare instead.

1. When using the B5-2C/2Q/2LA, push the grip into

Luer-lock connector-1. Confirm that the grip is
securely attached to Luer-lock connector-1.

2. When using the B7-2C/2Q/2LA, insert the wire of the

stylet through Luer-lock connector-1 into the tube.
Mount the grip onto Luer-lock connector-1. Make
sure the stylet is securely attached.

3. Screw the stopcock connector into Luer-lock

connector-2. Make sure the stopcock is securely
attached.

DISPOSABLE BALLOON CATHETER

17

Chapter 4 Preparation, Inspection and Operation

4. Confirm that the branch and Luer-lock connectors

are free from disconnection or looseness.

Inspection of Operation

• The volume of air in the balloon should

• Do not inflate the balloon rapidly.

• Inflate the balloon with air only. Inflation

If any of following steps reveals irregularities, do not use
the instrument; use a spare instead.

not exceed the parameters specified in
the tables in Section 2.2,
“Specifications”. Otherwise, the balloon
may burst.

Otherwise, the balloon may burst.

with anything other than air may hinder
expansion and contraction of the balloon.

18

1. Confirm that the stopcock knob is positioned as

shown in Figure 4.1.

Knob position
when the stopcock
is open.

Stopcock

Figure 4.1

Knob

Air
Feeding

Port

Syringe

2. Connect the sterile syringe onto the air feeding port

(see Figure 4.1).

DISPOSABLE BALLOON CATHETER

Chapter 4 Preparation, Inspection and Operation

3. While referring to the tables in Section 2.2,

“Specifications”, slowly inflate the balloon to the
desired size. Confirm that the balloon inflates.

4. With the balloon inflated, turn the knob on the

stopcock 90° to close the stopcock.

5. Confirm that the balloon does not contract.

6. Turn the knob on the stopcock back 90° to open the

stopcock.

7. Pull the sterile syringe’s plunger to deflate the

balloon.

8. Remove the grip from Luer-lock connector-1.

9. When using the B7-2C/2Q/2LA, withdraw the stylet

from the tube.

10. Insert the guidewire into the opening at the distal

end of the tube. Confirm that the guidewire pokes
smoothly and sufficiently out of Luer-lock
connector-1.

Inspecting Irrigation

Do not use the instrument if the contrast medium,
medical fluid or saline solution cannot be injected or if it
leaks from any area other than the distal end. In this
case, use a spare instead.

Use a contrast medium, medical fluid or
saline solution intended for patient use
when inspecting irrigation. Other fluids
may remain inside the channel and could
pose an infection control risk or cause
tissue irritation.

DISPOSABLE BALLOON CATHETER

19

Chapter 4 Preparation, Inspection and Operation

1. When using the B5-2C/2Q/2LA, push the grip into

Luer-lock connector-1. Confirm that the grip is
securely attached to Luer-lock connector-1.

2. When using the B7-2C/2Q/2LA, insert the stylet wire

into the tube through Luer-lock connector-1. Then
mount the grip onto Luer-lock connector-1 and
confirm that the stylet is securely attached.

3. Inject contrast medium, medical fluid or saline into

the instrument’s injection port using a sterile syringe.
Confirm that the fluid comes out of the distal end
(see Figure 4.2).

Injection Port

Syringe

20

Figure 4.2

4. Make sure that the contrast medium, medical fluid or

saline does not leak from any area other than the
distal end of the instrument.

5. Connect another syringe containing air to the

instrument’s injection port. Inject air into the insertion
portion to discharge the contrast medium, medical
fluid or saline solution.

DISPOSABLE BALLOON CATHETER

4.3 Operation

The operator of the 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. It only describes basic
operation and precautions related to the operation of this
instrument.

Chapter 4 Preparation, Inspection and Operation

• When using the instrument, always wear
appropriate personal protective
equipment. Otherwise, blood, mucous
and other potentially infectious material
from the patient could pose an infection
control risk. Appropriate personal
protective equipment may include: Eye
wear, a face mask, moisture-resistant
clothing and chemical-resistant gloves
that fit properly and are long enough so
that your skin is not exposed.

• Do not use the balloon catheter to
retrieve a calculus which is larger than
the fistula or lumen size. Doing so could
cause patient injury such as
hemorrhages or mucous membrane
damage. It could also burst the balloon or
cause the balloon to become stuck in the
fistula or lumen, resulting that the distal
end of the instrument breaks off and
remains inside the fistula or lumen.

DISPOSABLE BALLOON CATHETER

21

Chapter 4 Preparation, Inspection and Operation

• Do not insert the instrument into the

• Do not angulate the bending section of

• Do not force the distal end of the

endoscope unless you have a clear
endoscopic field of view. If you cannot
see the distal end of the insertion portion
in the endoscopic field of view or in the
X-ray images, do not use it. This could
cause patient injury, such as punctures,
hemorrhages or mucous membrane
damage. It may also damage the
endoscope and/or instrument.

the endoscope (or operate the forceps
elevator if applicable) abruptly while the
distal end of the insertion portion is
extended from the distal end of the
endoscope. This could cause patient
injury, such as punctures, hemorrhages
or mucous membrane damage.

insertion portion against body cavity
tissue. This could cause patient injury,
such as punctures, hemorrhages or
mucous membrane damage.

22

• The volume of the air in the balloon
should not exceed the parameters
specified in the tables in Section 2.2,
“Specifications”. Otherwise, the balloon
may burst or may not deflate properly.
When the balloon does not deflate, do
not operate the balloon catheter with
excessive force. Otherwise, the distal
end of the instrument may break off and
could remain inside the patient.

• Do not inflate the balloon rapidly. The
balloon may burst and mucous
membrane damage can result.

DISPOSABLE BALLOON CATHETER

Chapter 4 Preparation, Inspection and Operation

• Inflate the balloon with air only. Inflation
with anything other than air may hinder
contraction of the balloon and make
impossible to withdraw the instrument
from the body cavity.

• When using the B7-2C/2Q/2LA, do not
withdraw the stylet from the tube quickly.
Infectious substances attached to the
stylet such as the patient’s blood and
mucous may scatter, posing an infection
control risk.

• When using the B7-2C/2Q/2LA, be
careful when handling the distal end of
the removed stylet. The stylet has a very
sharp tip and accidental punctures may
pose an infection control risk or cause
tissue irritation.

Inserting Into the Endoscope

• Confirm that the balloon is completely
deflated when inserting the instrument
into the endoscope. If the balloon is
inflated, the distal end of the instrument
may extend from the distal end of the
endoscope abruptly. This could cause
patient injury, such as punctures,
hemorrhages or mucous membrane
damage. It may also damage the
endoscope and/or instrument.

• When using a guidewire, hold the
guidewire when inserting the instrument.
Otherwise, it will move with the
instrument. This could cause patient
injury, such as punctures, hemorrhages
or mucous membrane damage.

DISPOSABLE BALLOON CATHETER

23

Chapter 4 Preparation, Inspection and Operation

• Do not force the instrument if resistance

• Do not advance or extend the instrument

• When inserting the instrument into the

• Insert the instrument slowly. Abrupt

to insertion is encountered. Reduce the
angulation (or lower the forceps elevator
if applicable) until the instrument passes
smoothly. This could cause patient injury,
such as punctures, hemorrhages or
mucous membrane damage. It may also
damage the endoscope and/or
instrument.

abruptly. This could cause patient injury,
such as punctures, hemorrhages or
mucous membrane damage. It could
also damage the endoscope and/or
instrument.

endoscope, hold it close to the biopsy
valve and keep it as straight as possible
relative to the biopsy valve. Otherwise,
the insertion portion could be damaged.

insertion could damage the endoscope
and/or instrument.

24

DISPOSABLE BALLOON CATHETER

Chapter 4 Preparation, Inspection and Operation

 Using the B5-2C, B7-2C

1. Carefully insert the instrument into the biopsy valve

or T-plug (see Figure 4.3).

Keep as straight as
possible.

Hold the
insertion portion
close to the
biopsy valve.

Biopsy Valve

Figure 4.3

2. Advance the instrument until the distal end of the

insertion portion appears within the endoscopic field
of view.

 Using the B5-2Q/2LA, B7-2Q/2LA

When using the B5-2Q/2LA or
B7-2Q/2LA, raise the forceps elevator to
its maximum height. If the forceps
elevator is down, you will not be able to
see the distal end of the insertion portion
in the endoscopic field of view. This could
cause patient injury, such as punctures,
hemorrhages or mucous membrane
damage.

1. Raise the forceps elevator to its maximum height.

2. Carefully insert the instrument into the biopsy valve

(see Figure 4.3).

DISPOSABLE BALLOON CATHETER

25

Chapter 4 Preparation, Inspection and Operation

3. When using a guidewire, hold the guidewire in

position and insert the instrument into the
endoscope along the guidewire.

4. When the distal end of the insertion portion contacts

the forceps elevator, lower the forceps elevator.

5. Advance the instrument another 20 mm and raise

the forceps elevator. The distal end of the instrument
will be visible in the endoscopic field of view.

Applications

 Radiography, Injecting medical fluid,

and Irrigation

1. When using the B5-2C/2Q/2LA, push the grip into

Luer-lock connector-1. Confirm that the grip is
securely attached to Luer-lock connector-1.

2. When using the B7-2C/2Q/2LA, insert the stylet wire

into the tube through Luer-lock connector-1. Then
mount the grip onto Luer-lock connector-1 and
confirm that the stylet is securely attached.

26

3. Connect a sterile syringe filled with a contrast

medium, medical fluid or saline solution to the
injection port. Inject the fluid until the air inside the
Tube is forced out.

4. Insert the distal end of the instrument into the target

site.

5. Confirm that the stopcock is open (see Figure 4.1).

6. Mount the sterile syringe onto the air feeding port.

Inject the specified amount of air into the instrument
(see the tables in Section 2.2, “Specifications” to
inflate the balloon).

7. Turn the knob on the stopcock 90° to close the

stopcock.

DISPOSABLE BALLOON CATHETER

Chapter 4 Preparation, Inspection and Operation

8. Depress the sterile syringe’s plunger to inject the

fluid.

 Retrieval

• When retrieving a foreign object, do not
operate the instrument abruptly or with
excessive force. Doing so could cause
patient injury, such as hemorrhages or
mucous membrane damage. It could
also burst the balloon or impede its
deflation, which could cause the balloon
catheter to become stuck inside the
patient, or cause the distal end of the
instrument to break off and remain inside
the patient.

• If the balloon becomes stuck, slowly
withdraw it together with the endoscope
and confirm that there is no bleeding.
Forcibly withdrawing the instrument
could cause its distal end to break off and
remain inside the patient.

1. Insert the distal end of the instrument into the target

site.

2. Confirm that the stopcock is open (see Figure 4.1).

3. Mount the sterile syringe onto the air feeding port.

Inject the specified amount of air into the instrument
(see the tables in Section 2.2, “Specifications” to
inflate the balloon).

4. Turn the knob on the stopcock 90° to close the

stopcock.

5. Pull the instrument to clear the foreign object.

DISPOSABLE BALLOON CATHETER

27

Chapter 4 Preparation, Inspection and Operation

 Hemostasis

1. Insert the distal end of the instrument into the target

site.

2. Confirm that the stopcock is open (see Figure 4.1).

3. Mount the sterile syringe onto the air feeding port.

Inject the specified amount of air into the instrument
(see the tables in Section 2.2, “Specifications” to
inflate the balloon).

4. Turn the knob on the stopcock 90° to close the

stopcock.

 Changing the Patient’s Position (B5-2LA

and B7-2LA Only)

• Do not remove the endoscope from the
body cavity quickly. Infectious
substances attached to the endoscope
such as blood or mucous may scatter,
posing an infection control risk.

28

• Hold the instrument when reinserting the
endoscope. Otherwise, the instrument
will move with the endoscope. This could
cause patient injury, such as punctures,
hemorrhages or mucous membrane
damage.

• Do not withdraw the endoscope past the
instrument’s Branch. If the endoscope is
withdrawn further, the instrument will
move with the endoscope. This may
cause mucous membrane damage.

1. Leave the instrument inside the patient and

completely withdraw the endoscope from the body
cavity.

DISPOSABLE BALLOON CATHETER

Chapter 4 Preparation, Inspection and Operation

2. Change the patient’s position.

3. Insert the endoscope into the body cavity again.

Withdrawing the Instrument From the Endoscope

Do not withdraw the instrument from the
endoscope quickly. This could scatter
blood, mucous, or other patient debris
and pose an infection control risk.

• Do not withdraw the instrument from the
endoscope while the balloon is inflated.
This could damage the endoscope
and/or instrument.

• Do not withdraw the instrument from the
endoscope if the forceps elevator is up.
This could damage the instrument.

1. Turn the knob on the stopcock back 90° to open the

stopcock.

2. Pull the sterile syringe’s plunger to deflate the

balloon.

3. If the endoscope is equipped with a forceps elevator,

lower the forceps elevator.

4. Withdraw the instrument from the endoscope.

Disposal

• After use, dispose of the instrument in an
appropriate manner. If it is not properly
disposed of, it could pose an infection
control risk.

DISPOSABLE BALLOON CATHETER

29

Chapter 4 Preparation, Inspection and Operation

• The instrument is a single-use,

After using the instrument, dispose of it in an appropriate
manner.

disposable item. Do not reuse or attempt
to sterilize. Reusing the instrument could
pose an infection control risk, cause
tissue irritation or malfunction.

30

DISPOSABLE BALLOON CATHETER

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