TS12140 AND TS13140 OPERATIONAL MANUAL

Important Safety Information

Important Safety Information 1. Intended Use This product is intended to be used in combination with a Fujinon small intestinal scope to assist insertion of the Endoscope. Never use this product for any other purposes. This product is not intended for use for any child or baby.

2. Safety Read and understand this manual carefully before use. Use the Over-tube by following the provided instructions. Items important for the safe use of the Over-tube are summarized in Chapter 1 “Safety.” Safety precautions associated with individual operations or procedures are provided separately, indicated “

WARNING” or “

CAUTION.”

3. Warning Matters that must be followed with special care in using the product are indicated “

WARNING” or “

CAUTION.” Perform procedures correctly by reading and

understanding the warning information carefully.

WARNING Improper use or operation of the equipment may injure patients, physicians, or people in the vicinity. Read and understand this manual carefully before operating the equipment.

Improper operations that will damage the equipment only are identified by “CAUTION.”

4. About Clinical Procedures This manual assumes that the product will be used by medical specialists who have received proper training in endoscopic procedures. It does not provide information about clinical procedures. Regarding clinical procedures, use proper clinical judgment.

2

Important Safety Information Contents

5. “

Warning” and “

Caution” Messages Appearing in “Chapters 3 Method of Use”

3.1 Preparation of Over-tube It may cause anaphylactic reaction. Do not use it for patients with a latex allergy. 3.2 Insertion It may damage the walls of the digestive tract. Insert or pull out the Over-tube slowly. Do not press the Over-tube forcibly on the wall of a digestive tract. Do not insert or pull out the overtube with the balloon inflated.

Contents Important Safety Information ... 2 Preface ... 4 Conventions Used in This Manual ... 4 Chapter 1

Safety ... 5

Chapter 2

Names and Functions of Parts ... 6 2.1 Over-tube ... 6

Chapter 3

Method of Use ... 7 3.1 Preparation of Over-tube ... 7 3.2 Insertion ... 8 3.3 Pulling Out ... 11

Appendix ... 12 Warranty and After-Sales Service ... 12 Main Specifications ... 13

3

Preface Important Safety Information

Preface This manual describes how to use, clean, sterilize, and store the Over-tube TS-12140 and TS-13140. The Over-tube is used with a Fujinon small intestinal Endoscope. Read the operation manual of a Fujinon small intestinal Endoscope, too.

Conventions Used in This Manual This manual uses the following conventions to make it easy to understand operations. General conventions Convention

Meaning Indicates a potential danger that may harm to people.

WARNING

Explains the dangerous conditions that may cause to death or serious accident unless it is avoided.

CAUTION

Explains the conditions that may cause to light or medium injury unless it is avoided.

CAUTION

Explains the conditions that may damage to equipment unless it is avoided.

(1), (2), (3), ...

Consecutive numbers in operating procedures indicate the sequence of successive operations.

[Note]

Indicates a comment or supplementary information. Indicates a reference.

Conventions on the label of the sterile pack and individual packaging box (ISO15223) Convention STERILE EO

Meaning Sterilized with EOG. Do not reuse. Manufacturing date Expiry date

LOT

Lot

Note

[Note] There are two types of lots: sterile lots and manufacturing lots.

4

Chapter 1 Safety

Chapter 1 Safety 1. Precautions in Using Over-tube 1) Inspection before use Make sure to inspect the equipment before use according to the procedures provided in this manual, to avoid unexpected accidents, and take full advantage of the equipment’s capabilities. If the inspection result shows any abnormality, do not use the same equipment. 2) Combination of equipment This product is designed to be used exclusively for a Fujinon small intestinal Endoscope. Be sure to use it together with a Fujinon small intestinal Endoscope.

2. Handling of the Over-tube STERILE EO

This Over-tube is sterilized with ethylene oxide gas in advance. If the sterilized pack is broken, do not use it. Use this product by the expiry date.

3. Do not reuse This product is intended for single use. To prevent infection, do not reuse this product.

4. Allergy to natural rubber This product is used with a product that contains natural rubber as a material. Natural rubber may rarely cause allergy symptoms, such as itching, reddening, hives, swelling, fever, dyspnea, asthma-like symptoms, drop of blood pressure and shock. If such symptoms are observed, stop use immediately and take appropriate measures.

5. Use of the balloon Overinflation of the balloon may damage the intestinal tract. When using the balloon, the operator should conduct sufficient basic practice outside the body and learn the degree of inflation of the balloon before using it.

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Chapter 2 Names and Functions of Parts

Chapter 2 Names and Functions of Parts 3

2.1 Over-tube

2

4

1

5 7 6 Scope insertion inlet Insert the Endoscope from here. Insertion portion This portion can be inserted into the body cavity. Attaching portion The balloon is attached with this portion. Balloon This part is swollen, and an Over-tube is maintained into body cavities. Air feed inlet (clear tube) Air is fed and taken out from here. When air is fed, the balloon inflates. When air is taken out, the balloon deflates. Water feed inlet (blue tube) Water can be injected into the inside of the Over-tube from here. Check valve This valve prevents body fluids from flowing out of the scope insertion inlet.

6

Chapter 3 Method of Use

Chapter 3 Method of Use 3.1 Preparation of Over-tube

WARNING It may cause anaphylactic reaction. Do not use it for patients with a latex allergy.

(1) Before using the Over-tube, please confirm the following about it: It conforms to the Endoscope to be used There is no breakage in the sterilized pack The expiry date has not passed “Main Specifications”

(2) Remove the Over-tube from the sterilized pack.

(3) Visually check the insertion portion for abnormalities such as flaws or dents and for sharp edges on protrusions that may injure the patient.

(4) Fill with air through the air feed inlet (clear tube) and confirm the inflation of the balloon.

7

Chapter 3 Method of Use

3.2 Insertion

WARNING It may damage the walls of the digestive tract. Insert or pull out the Over-tube slowly. Do not press the Over-tube forcibly on the wall of a digestive tract. Do not insert or pull out the over-tube with the balloon inflated.

[Note] If any resistance is felt, stop using it immediately. When using this product, check the status of the balloon, over-tube and Endoscope by X-ray fluoroscopy. (1) Have the patient hold the mouthpiece in his/her mouth. (2) Moistening the inside of Over-tube with clear water.

(3) Insert the Endoscope from the scope inlet of the guide tube and fix the Over-tube to the scope root. [Note] If the Endoscope and Over-tube do not slide smoothly, inject water from the water feed inlet (blue tube) using the syringe.

8

Chapter 3 Method of Use

(4) Apply clean lubricant (Xylocaine jelly or the like) to the insertion portion and the Over-tube as required.

(5) Insert the Endoscope with the attached Over-tube through the oral cavity.

(6) Feed air to inflate the balloon on the distal end of the Endoscope, and fix it to the enteric canal

[Note] When used for the average gastrointestinal tract, the amount of air injected into the balloon by the syringe is 40 ml. The amount of air injected should range from 35 to 50 ml,

40

depending on the site of use or circumstances. Use at the affected site or adhesion site should be judged from the professional viewpoint.

9

Chapter 3 Method of Use

(7) Insert the over-tube along the Endoscope to the point close to the balloon on the distal end of the Endoscope. (8) Feed air to inflate the balloon on the over-tube, and stabilize it in the body cavity (small intestine).

(9) Discharge air to deflate the balloon on the distal end of the Endoscope. (10) Insert the Endoscope.

(11) Feed air to inflate the balloon on the distal end of the Endoscope, and stabilize it in the body cavity (small intestine).

(12) Discharge air to deflate the balloon on the over-tube. (13) Insert the over-tube along the Endoscope to the point close to the balloon on the distal end of the Endoscope.

10

Chapter 3 Method of Use

(14) Feed air to inflate the balloon on the over-tube, and stabilize it in the body cavity (small intestine). (15) Repeat steps (9) through (14) to insert the Endoscope.

3.3 Pulling Out (1) Slowly pull out the Over-tube and the scope together. (2) The used Over-tube should be disposed.

11

Appendix

Warranty and After-Sales Service 1)

If the equipment does not work properly, check it first reading this manual.

2)

If the equipment is still not working well, ask for professional help. Consult your local dealer or FUJINON representative.

3)

Warranty period If your equipment does not work properly and caused by the manufacture’s fault under the warranty period, we will exchange your equipment with new one. The warranty period is half year from the date of purchase. Note that the warranty is void in the following cases: a. Damage caused by fire or natural disaster such as storms or floods. b. Troubles caused by careless handling or misuse of the product on the part of the user. c. Troubles caused by repair or modification by an unauthorized person.

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Appendix

Main Specifications <Specifications> Model

TS-12140

TS-13140

Applicable endoscope

EN-450P5/20

EN-450T5 EN-450T5/W

Effective length (mm)

1350

1350

Overall length (mm)

1450

1450

Outer diameter of the insertion portion (mm)

12.2

13.2

Inner diameter of the insertion portion (mm)

10

10.8

Outer diameter of the balloon (mm)

40

40

Effective length of the balloon (mm)

50

50

Check Valve

Yes

Yes

<Operating Environment> Temperature

10 - 40°C

Relative humidity

30 - 85% Note

Atmospheric pressure

70 - 106 kPa

Note: Except when there is condensation

<Storage Conditions>

Temperature

10 - 40°C

Relative humidity

30 - 85% Note

Atmospheric pressure

70 - 106 kPa

State of Over-tube

Keep in the individual packaging box Note: Except when there is condensation

<Medical Device Directive> This product complies with the requirements of European Directive 93/42/EEC. Classification : Class IIa

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Appendix

14

Appendix

15

manufacturer

FUJINON CORPORATION 1-324 UETAKE-CHO, KITA-KU, SAITAMA-SHI, SAITAMA 331-9624, JAPAN TEL : 81-48-668-2153 FAX : 81-48-668-1570 represented in the North America by

FUJINON INC. 10 HIGH POINT DRIVE, WAYNE, NJ 07470, U.S.A. TEL : 1-973-633-5600 FAX : 1-973-633-8818 authorized representative in the EU, Middle East and Africa by

FUJINON (EUROPE) GmbH HALSKESTRASSE 4,47877 WILLICH, GERMANY TEL : 49-2154-924-0 FAX : 49-2154-924-290 represented in the South East Asia by

FUJINON SINGAPORE PTE. LTD. BLK 211 HENDERSON ROAD, #10-04 HENDERSON INDUSTRIAL PARK, SINGAPORE, 159552 TEL : 65-6276-4988 FAX : 65-6276-6911 represented in the Oceania by

FUJINON AUSTRALIA PTY. LTD. UNIT-18, 52 HOLKER STREET, SILVERWATER N.S.W. 2128, AUSTRALIA TEL : 61-2-9748-2744 FAX : 61-2-9748-2428

FW 618A

202B11446100 0607- 3.0-DT - E Pr i n ted i n J apan