[23] Whenis found on the label, it means the product doesn’t contain DEHP

< Duration of Use >in the contact part with body fluid and drug solution.

Transanal Ileus Decompression Tube Set

This product is designed to be “used for 29 days or less.” Avoid using the product[24] Any serious incident that has occurred in relation to the device should beTransanal Ileus Decompression Tube Set
Transanal Decompression Tubefor more than 30 days.

reported to the manufacturer and the competent authority of the Member Statein which the user and/or patient is established.

< Expiration date >• See the expiration date indicated on each package for the products stored in an< Defects >[1] Burst of the cuff
(Burst due to the following reasons) Damage due to improper handling when inserting the product(damage by tweezers, forceps, scissors, knives, or other devices) Excessive infusion volume (overexpansion) Infusion of incorrect substance for balloon inflation (Substances
liable to cause coagulation of components such as physiologicalsaline and contrast medium) Abrupt load due to self-(accidental) removal, etc.
 Other multiple causes due to the above-mentioned events[2] Blockage of catheter

Do Not Reuse (For Single Patient Use Only)

appropriate storage conditions.
• Store the product with sufficient care and do not use after the expiration date.

 2-channel connector[Warning] When using this product, make sure to perform the procedure
while able to directly visualize the product via the endoscope, as well as
under fluoroscopic guidance.
 As the following events may occur during deployment ofsilicone balloons, always control the extent of balloon expansion.
(Balloon deflation due to lots of spontaneous leakage compared with thelatex balloon.)

Connector

Tube
ClampFunnel

DC61894 (MDR 1st Edition) Prepared on January 7, 2021
 Guide wire[Contraindications / Prohibitions] Do not reuse this product (for single use only).
(This product is disposable for single use, and of which thequality and performance are not guaranteed after use.
In addition, reuse of the product may carry the risk ofcontamination (infection) on patients. Contamination of theproduct may result in injury, disease, or death of patients.)
 Do not reprocess or resterilize this product.
(Reprocessing of this product may cause the product tomalfunction. In addition, it may result in injury, disease, ordeath of patients.)
 Do not use for cases which cannot tolerate large intestine
endoscopy, multiple stenosis cases, cases with peritonitis.
 Do not use other than sterilized distilled water for balloon
expansion.
(When physiological saline solution, contrast medium, etc. are used,
there is a possibility that sodium chloride will appear after drying and it
cannot be drained.)(Adhesion of intestinal contents, contrast medium, etc. to the catheter lumen may
lead to blockage.)[3] Inability of removal of catheter(Coagulation of components due to using saline or contrast medium for balloon
expansion and excessive bending of the catheter tube may cause blocking
and unremovable from the balloon lumen.)[4] Disconnection of tube
(Disconnection due to the following reasons) Damage with tweezers, forceps, scissors, scalpels, or other instruments.
 Abrupt load on the product due to self-(accidental) removal.
 Other multiple causes due to the above-mentioned events.
[5] Bending, bending, damage, cutting of the guide wire.
(Breaking, bending, damage, or cutting due to the following reasons.)
 Impossible insertion, removal, excessive torque operation, etc.
 Use for kinked tubes.
 Other multiple causes due to the above-mentioned events.
[6] Inability of removal of guide wires

Tip part（ flexible touch）

 Dilator designed for the opened forceps

T i p t a p e r p a rt

 Dilator for dilating stenosis
Tip taper part

< Raw materials >[ Form, Structure]
・This product is sterilized with ethylene oxide gas.

(Inability of removal due to the following)

Rear end part
（ hard touch）

 Transanal Decompression Tube：
Silicone rubber，polyester or Polycarbonate，polypropylene

・This product (guide wire) uses metal.

 2-channel connector：PVC，Polycarbonate，polypropylene

 Bending, bending, damage, cutting of the guide wire.
 Decrease in lubricity.

 Guide wire：Stainless steel, Polytetrafluoroethylene<Product components>

 Use for kinked tubes.
 Other multiple causes due to the above-mentioned events
Transanal Ileus
Decompression TubeSet< Adverse events >[1] Adverse events which may be associated with the use of the productinclude:Transanal
Decompression Tube

 During insertion：
Intraperitoneal infection caused by bleeding, intestinal perforation,

Component
Transanal Decompression Tube
2-channel connector
Guide wire
Dilator designed for the opened
forceps
Dilator for dilating stenosis
Transanal Decompression Tube
2-channel connector

 Dilator designed for the opened forceps：Polyethylene

QTY
111

 Dilator for dilating stenosis：PVC<Shape>1

 Transanal Decompression Tube
SizeO.D.
Total length
designation
500 to22Fr
7.3mm
2000mm111perforation.
 During depressurization：

 Guidewire
Designation<Shape>Intestinal necrosis, ulcer due to intestinal compression or intestinal

 Transanal Decompression Tubeperforation.
[2] The use of guide wires may cause the following adverse events.

Air vent hole

 Damage (perforation, etc.)

G/W.052"3000T

Balloon position
confirmation marks
One-way valve

 Bleeding[3] Remains in the body due to the cutting tube.

Valve
Tip hole
Suction side hole

[ Storage Conditions and Expiration Date, etc. ]BalloonB A LL< Storage Conditions >Air ventport

TSuction port

The product should be stored in a clean and dry place away from direct sunlight,

Catheterhigh temperature and humidity, and ultraviolet rays such as germicidal light.

Bifurcation

O.D.

Total length

1.32 mm(0.052")

3000mm Dilator designed for the opened forceps
Size
O.D.
Total length
designation
8Fr
2.7mm
2000～4000mm

Funnel Dilator for dilating stenosis
Size
O.D.
designation
26Fr

4／4

30mL

Tip hole /Side hole
Open tip
4 to 6 side holes

Specification
Fixed straight(Soft tip type)
Teflon coating

Specification
All radiopaque

Air ventconnector.

V ENMaximum
balloon capacity

1／4

8.6mm

Total length

Specification

1000mmRadiopaque withtapered rear end

<Principle>
Insert the product from the anus into the intestine and inflate the balloon to secure
the probe in the desired location.
Perform the decompression of intestinal gas, aspiration of intestinal contents andcolonoscope and grasp the state of the narrowed part under X-ray fluoroscopy.

＜Concomitant devices＞

When the contrast agent does not enter the stenosis, there are cases where the[1] When using this product, use it in combination with the following devices.
NameSpecificationEndoscope
・Channel diameter：2.8 mm or more・Total length：Not more than 1700 mm
・Specification：For use in colon
Syringe・Slip type・Capacity：20 - 50mL
Syringe
Catheter tip type
Sterilized distilled water－
Low pressure continuous
End shape：
suction machine
Catheter tip shape or bamboo shoot shape・Suction pressure：－980～－2450Pa (－10～－25cmH2O)
Drainage bag
End shape：
Catheter tip shape or bamboo shoot shape
Lukewarm water－

stenosis can be imaged by pushing the contrast agent in the air (double contrastmethod).

injection of a water soluble contrast agent/medium for upper GI series like[2] Insert the guide wire slowly and carefully into the lumen of the narrowed part,

gastrografin.

after passing through the stenotic part, send it to the deep part (30 to 40 cm ormore) together with the dilator designed for the opened forceps.

[Intended use][3] While leaving the guide wire and the dilator designed for the opened forceps

This product is inserted transanally and used for the intestinal decompression,in the intestinal tract, while pushing slightly, remove only the endoscope.

aspiration of intestinal contents and injection of medicinal solution.

[4] Insert the dilator for dilating stenosis slowly and carefully along the dilator

The dilators are used for facilitating the catheter insertion or dilating the stenotic part.

designed for the opened forceps and let it pass through the stricture.
[5] Remove the dilator for dilating stenosis while leaving the guide wire and the[Efficacy or Effect][ Precautions ]< Important Precautions >[1] Using oily components such as castor oil, surfactants, alcohol, etc. may cause
cracks to the 2-channel connector.
[2] Insert the 2-channel connector, etc. straight along the funnel cavity whenconnecting a 2-channel connector, etc. to the funnel. Do not apply a load suchas bending, twisting, or pinching the funnel in this state.
[Damaging the funnel cavity to the tip of a 2-channel connector, etc. may
causes cracks or breaks in the funnel.][3] During indwelling, take a photograph of abdominal X-rays regularly, andconfirm that decompression of the intestinal tract is performed surely.
Confirm that the tube is not dislodged by contrast, and whether the tip ispressing the intestinal tract if necessary. (When the lumen is clogged, wash thedilator designed for the opened forceps in the intestinal tract.

Intestinal gas can be depressurized, intestinal contents can be aspirated, and drug

[6] Insert the decompression tube slowly and carefully along the dilator designed

solution can be injected.

for the opened forceps and insert until the balloon portion passes through thestenotic site.

[Specifications and performance]
・Secure the level of sterility assurance (SAL) 10-6.
・Sterilization residue: Conforms to ISO10993-7.
・Does not contain materials of biological origin and is biocompatible
with biological safety.
・Can withstand 29 days of continuous use.
・To be stable and durable for 5 years.
・Balloon maximum capacity 30 mL
・Tensile strength
This product does not tear when both ends of the product are exposed to thefollowing forces in a longitudinal direction.
Transanal Decompression Tube 20N
2-channel connector 30N[7] Inject 30 mL of sterilized distilled water into the balloon.
[8] Confirm that the balloon is expanded and securely caught in the stenosis(decompression tube does not come off). (Check the balloon part with two"balloon position confirmation marks".)[9] Aspirate and inject 100 to 300 mL of lukewarm water from the suction port
repeatedly as much as possible to reduce the pressure in the dilated intestinal
tract. (At this time, occasionally, posture transformation or manualcompression of the abdomen is used together.)[10] Insert the balloon slowly and carefully so that the balloon portion is about
10cm deeper than the narrowed portion, place it. In this case to place the tip ofthe decompression tube at a position that does not hit the intestinal wall. Also,[Operating or using method]make sure not to catch the balloon on the stenosis.

The following method of use is a typical usage.

[11] After applying the two clamps of the 2-channel connector, connect the 2channel connector to the suction port of the decompression tube.

< What to prepare >[12] Put a syringe for washing to one of the funnels, release the clamp and inject

 Colonoscope

200 to 300 mL of lukewarm water in the intestinal tract.

 Contrast agent
It is used to grasp the condition of the stenotic region after inserting the colon[13] Clamp after injection and leave it for a while.
[14] Release the clamp of the other funnel, connect the low pressure continuousendoscope. Water-soluble gastrointestinal contrast medium is suitable.

suction device or drainage bag and drain. Or place a drainage container and Olive oil
It is used for smooth operation of this product.

drain.
3) After indwelling, treatment after the second day Syringe
It is used for balloon expansion. A general slip type syringe of 20 to 50 mL is

For the treatment on the second day after indwelling, wash the intestinal tract
thoroughly with 2) "Emergency depressurization procedure [12] to [14]"required.

mentioned above repeatedly with a total of 2000 to 3000 mL lukewarm water.

A catheter tip type syringe is required for washing intestinal contents.

During indwelling of this product, wash at least once a day until ileus improves.

 Sterile distilled water

Wash once a day after improvement. (If cleaning operation is omitted, the tube

Prepare for balloon water injection.

may clog.)

 Low pressure continuous suction machine
It is used for decompression in the intestinal tract.

4) During surgeryRemove decompression tube when performing intestinal resection. At this time, Lukewarm water
It is used for washing the inside of the intestinal tract after placing thecontract the balloon immediately before resection of the intestinal tract, pull out
the decompression tube slightly to the anus side from the narrowed part, expand

decompression tube.

the balloon again with 30 mL of sterilized distilled water, and remove thedecompression tube after removing the intestinal tract on the anal side.

< Usage >lumen of the tube with lukewarm water.)[2] Medical drug compatible to this productProducts nameNonproprietary name
Gastrografin
Amidotrizoic Acid
Olive oil
Olive oil
Xylocaine-jelly
Lidocaine
Do not use other medical drug.

[4] Do not force suction.
(There is a risk of damaging tissue.)[5] Do not intentionally block air vents during decompression therapy.
(Decompression / suction may not be operate.)[6] Remove all of the sterilized distilled water in the balloon as a guide once a week
and inject sterile distilled water of the recommended capacity again.

＜Precautions for use related with the using procedure＞[7] Be careful when use X-rays to a pregnant patient or a patient with the[1] Before using this product, make sure that the balloon surely expands andpregnant possibility.

contracts.

(Concerned about the effects on the embryo by X-rays.)[2] To spread a balloon, use a general slip type disposable syringe.

[8] Before using the product, make sure that each component works(In the lock type syringe, it cannot be surely inserted in the depth of valve.

properly.

Also, if the taper does not match, the valve will be damaged.)[9] Do not insert forcedly. If insertion is difficult, stop using the tube andt

[3] When expanding or contracting the balloon, make sure that the tip of the syringe

ake appropriate measures.

is inserted deeply into the valve and operate.

(It may cause damage on the tissue.)(Insufficient insertion of the tip of the syringe in the valve, the valve does not[10] Do not insert or remove forcedly. Operate the product with aoperate and the balloon cannot be operated in some cases.)caution.

[4] When removing the syringe, always hold the valve and remove the syringe(It may cause damage on the product.)while turning it.

[11] If any problem is found, stop using the product as soon as possible(In rare cases, the valve may be misaligned, sometimes disengaged.)

and take appropriate measures.

[5] Use sterilized distilled water for balloon expansion, inject it slowly and carefully.

[12] Do not pull or bend the product forcedly. Handle the product(Rapid injection may result in dislocation or removal of the valve in rare

carefully and gently.

occasions due to its pressure.)[13] Do not modify the product.

[6] Do not inject sterilized distilled water more than the maximum capacity in the(Modification such as making additional side holes may causeballoon.

disconnection of tube.)(Excessive infusion causes a burden on the balloon, which causes bursting.)[14] Do not hold the product forcefully with forceps.

[7] Do not use other than the included guide wire.

(It may cause disconnection of the tube, obstruction of the lumen, or[8] Be careful that it is a danger of piercing the intestinal tract with the distal end ofdamage on the cuff.)

guide wire, the dilator designed for the opened forceps and the dilator for[15] Do not use the product if the package is broken or the product isdilating stenosis.

damaged.

[9] When indwelling the decompression tube, when washing the tube lumen and[16] Use the product soon after the package is opened and dispose theintestinal tract, be careful not to catch the balloon portion on the stenosis.

used product in a secure manner for each country.

[10] Make sure to clamp the 2-channel connector and fit with each part securely.

[17] When using this product and injecting the drug solution in the body, select(It causes liquid leakage.)the proper drug solution under the responsibility of the doctor. Also, refer to[11] Withdraw the decompression tube after aspirating the sterilized distilled water

the package insert of the chemical.

completely from the balloon.

[18] During placement, keep the device under full control to prevent its operation[12] Do not inject contrast agent and chemicals with possibility of crystallization

by an untrained person.

from the air vent port.

1) Preparation before the procedure[19] This product uses polyvinyl chloride (plasticizer: phthalate (2-ethylhexyl) =(It causes clogging and decompression and suction efficiency decrease.)[1] Insert the dilator designed for the opened forceps to near the distal end of theDEHP).

[13] When connecting a low-pressure continuous suction machine, etc. to the end

guide wire.

DEHP is included in the dilator for dilating stenosis.

tube, select the one fits perfect. After starting to use, make sure that no leaks or[2] The both inner lumens of the dilator for dilating stenosis and theDEHP is included in 2-channel connector.

looseness in the connection part, and use in a securely connected state.

decompression tube must be filled with approximately 5mL of olive oil for[20] When[14] When using the endoscope etc, make sure to refer to the package insert etc. ofsmoother insertion over the dilator designed for the opened forceps up toeach product.

behind the stenosis/stenose. (hereinafter referred to as "decompression tube").

is found on the label, it means the product contains DEHP.

[21] When using this product for pregnant women and lactating women who arelikely to be affected in addition to newborns and babies who are consideredhighly susceptible, to fully explain the risks from DEHP and obtain consent. It2) Techniques for emergency depressurization

harms to liver and kidney.

[1] Insert the endoscope up to the narrowing of the colon.

[22] WhenA contrast agent (25 to 100 mL) is injected from the forceps port of theis found on the label, it means that the product should not be used

if the package has been damaged or opened.
2／4

3／4