Olympus B-V231 Instructions

INSTRUCTIONS

Single Use 3-Lumen Extraction Balloon V

B-V231P-A, B-V231P-B

1 Symbols

Refer to instructions. Single use only

Use by (expiration date) Sterilized using ethylene oxide

Sterilization lot number Lot number

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.

Air feeding port to inflate the balloon.

This instrument’s injection outlet is
above the balloon.

Manufacturer

Compatible with a ø 0.89 mm
(0.035 inch) guidewire.

This instrument’s injection outlet is
below the balloon.

Authorised representative in the
European Community

2 Intended Use

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.

3 Instruction Manual

This instruction manual contains essential information on using these instruments 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. If you have any questions or comments about any information in this manual, please contact
Olympus.

4 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.

5 Signal Words

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.

6 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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7 Nomenclature and Function

Stopcock

Injection port

Attach a syringe here to inject contrast
media, medical fluids or saline.

Connector

Attach the guidewire port here as
necessary.

Model reference label

Knob

Opens/closes a valve to control the airflow.
When the valve is open, the balloon can be
inflated. After inflation, the knob is turned to
close the valve and prevent air from escaping.

Air feeding port

Attach a syringe here to inflate
the balloon with air.

V marking

Gives the user an
approximate indication of
how far the instrument
has been inserted into the
endoscope.

Pre-measured syringes
(3 types for 8.5, 11.5 and 15 mm inflation)

Gasket

8.5

11.5

15.0

Prevents the syringe from
injecting more air than
necessary into the balloon.

Marks (For ø 15.0 mm inflation only)

Provide approximate position of the
distal end of Gasket for ø 8.5 mm or
ø 11.5 mm inflation.

Vent

Distal end

Tub e

The channel through which air is fed into the balloon
from the air feeding port and through which contrast
media, medical fluids or saline is injected.

Insertion portion/working length

Balloon

Inflated/deflated using a
syringe attached to the air
feeding port.

Guidewire port

Indicates compatible guidewire size.

Hook

Attached to the boot of endoscope or ET
control device (H-V100, sold separately).

Distal end

Light-proof cap

Prevents the latex rubber
balloon from deteriorating
when transported or stored.
Remove before use.

Distal stylet

The packaged instrument has distal
stylet attached.
Remove it from the instrument
before use.

8Specifications

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.

This instrument is compatible with ET control device (H-V100, sold separately). For further information on use
of the H-V100, refer to its instruction manual.

8.1 Operating environment

Ambient temperature: 10 – 40°C (50 – 104°F), Relative humidity: 30 – 85%,
Air pressure: 700 – 1060 hPa (0.7 – 1.1 kgf/cm

2

) (10.1 – 15.4 psia)

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8.2 Specifications

Model B-V231P-A B-V231P-B
Shape of the balloon

Injection outlet location Above the balloon Below the balloon
Maximum insertion portion diameter (mm) ø2.7
Catheter O.D. (distal-proximal, mm (Fr)) 1.85 – 2.45 (5.5 – 7)
Working length (mm) 1900
Diameter after inflation (mm) ø 8.5/ø 11.5/ø 15.0
Compatible guidewire (mm (inch)) ø 0.89 (0.035)
Compatible Olympus

endoscopes

(All of these parameters
should be met.)

Medical Device Directive This device complies with the requirements of Directive

Others Compatible with ET control device

Model and length Working length less than 1400 mm

Channel inner diameter (mm)
(color code)

93/42/EEC concerning medical devices. Classification:
Class I

JF, TJF

ø 2.8, ø 3.2 (yellow)

ø 3.7, ø 4.2 (orange)

ø5.5 (pink)

9Storage

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

Store the instrument in the sterile package at room temperature in a clean and dry environment. Do not store it in direct
sunlight.

10 Preparation, Inspection and Operation

• 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.

• When inspecting or using the instrument, always wear appropriate personal protective equipment, such as
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. Otherwise, blood, mucus and other potentially infectious material
from the patient could pose an infection control risk and/or cause skin irritation.

• 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 use, prepare and inspect the instrument as instructed below. Should the slightest irregularity be
suspected, do not use the instrument; use a spare instead. Damage or irregularity may compromise patient
or user safety, pose an infection control risk, cause tissue irritation, perforation, bleeding or mucous
membrane damage and may result in more severe equipment damage.

• Do not coil the insertion portion with a diameter of less than 150 mm. This could damage the insertion
portion.

• Never use excessive force to operate the instrument. This could damage the instrument.

10.1 Preparation Spare instrument

Always have a spare instrument available.

10.2 Inspection

Wear appropriate personal protective equipment in accordance with their respective instructions manuals.

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