Tierrett Long Foley Catheter
Instructions for use
Contraindicated to re-use[CONTRAINDICATIONS・PROHIBITION]
Do not reuse the product (single use only).

[8] Remove the stylet slowly. If the urine is left without confirmation of outflow,[Shape, structure, principle][9] Fix the catheter to the skin with a bandage etc.

This product is sterilized with ethylene oxide gas.

[10] If necessary, put the catheter urine outlet with the cover (small) on the cover

inject sterile distilled water into the catheter and carefully remove because theinside of the catheter is dry and the stylet is difficult to remove.

(large), check that make sure to attach by gently pulling the cover (large).
When opening the cover (small), make sure to hold the cover (large) and<Shape>

slowly lift the cover (small) knob.

Valve fixing ringSide hole
BalloonValve
5Catheter
容量 0.8mL*Fr

Tip(Radiopaque)Urine outlet[11] When removing the catheter, suck the sterile distilled water of the balloon
with a syringe to shrink the balloon and slowly pull out the catheter.

StyletCover(large)
Cover(small)<Precautions for the using method>[1] Do not to touch the valve fixing ring.
[The fixing ring may come off and the valve may fall off.][2] Please note the following when inflating and deflating the balloon.
1) Use only sterile distilled water to inflate the balloon.
[When saline, contrast medium, etc. are used, the components may
coagulate and water may not be removed.]
2) Use a general slip-type disposable syringe to inflate or deflate the balloon.

・Transparent type
Size

O.D.

6Fr

2.0 mm8Fr

2.7 mmEffective length[With a lock type syringe, it is impossible to insert very inside of the valve. If

Recommended
balloon capacity

650 mm
850 mm
650 mm
850 mmthe taper does not match, the valve will be damaged.]

1 mL

3) When inflating and deflating the balloon, make sure to insert very inside of

3 mL[If the tip of the syringe is not inserted very inside of the valve, the inside

the valve and perform the operation.
valve may not operate and the balloon may not be perform the operation.]
4) Inflate the balloon slowly and carefully.

<Raw Materials>[Due to the pressure when injected suddenly, the valve may off and・Catheter: Silicone rubber

sometimes come off.]・Stylet: Ni-Ti

5) Do not inject more than the specified volume of sterile distilled water intothe balloon.

<Principles>[Excessive injection will overload the balloon and cause a burst.]

By injecting sterile distilled water from the valve with a syringe, the balloon

6) When removing the syringe, make sure to press the valve and rotate theinflates and can be placed. By sucking the injected sterile distilled water, theballoon shrinks and can be removed. Urine is discharged from the side holesyringe to remove.

through the lumen to the urine outlet.

[The valve may off and sometimes come off.][Intended purpose, efficacy or effect]
A flexible tube that is placed in the bladder for short-term use. This product has an
inflatable balloon at the distal end. Used for urinary catheterization.
[Operating or using method]
The below is a general procedure.

[3] When placing a catheter, after confirming the outflow of urine, insert asufficient length, then inflate the balloon with a specified volume of sterile
distilled water and pull lightly. If it cannot confirm the outflow of urine, inject
10 to 20 mL of saline solution through the urine outlet and confirm that thesaline is discharged immediately after opening the urine outlet. Or after
checking the outflow of urine after a while, inflating the balloon.
[4] When connecting a tube, etc. to the catheter urine outlet, make sure to selectthe one fits. During use, make sure no leaks or looseness in the connection[1] Disinfect (clean, wipe) the external urethral meatus and vulva.

part, and use in a securely connected state.

[2] Remove the product from the packaging material hygienically and apply alubricant to the catheter as required.
[3] Insert into the urethra and bladder using a stylet.
[4] Confirm that the tip of the catheter reaches the inside of the bladder (passes
through the external urethral sphincter muscle) and urine begins to flow out
from the urine outlet.
[5] Advance the catheter about 3 cm.
[6] Slowly inject a specified volume of sterile distilled water into the balloon toexpand.
[7] Gently pull the catheter so that the balloon hits the bladder neck. If it is doubt[5] When connecting a bamboo shoot connector, etc. to the catheter urine outlet,
insert a bamboo shoot connector, etc. straight along the urine outlet lumen. Do
not apply a load such as bending, twisting, or pinching the urine outlet in thisstate.
[The tip of a bamboo shoot connector, etc. may damage the cavity of the urine
outlet, leading to a crack or rupture of the urine outlet.][6] When fixing the catheter to the skin, use a bandage etc. and do not fix thecatheter directly with a thread.
[There is a risk of blockage or rupture.]that the catheter is inserted correctly, inject 10 to 20 mL of saline solution[7] Change the fixation position of the catheter as appropriate.

through the urine outlet and confirm that the saline is discharged immediately[8] If the catheter is fixed with a bandage, etc., peel off slowly and carefully whenremoving the fixation.

after opening the urine outlet.
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[If using a bandage with strong adhesiveness for a small-diameter catheter[3] Impossibility of the catheter removal.

when peeling off, the catheter may be overloaded and cut.][If the isotonic sodium chloride solution or contrast medium is used for theballoon inflation, the balloon lumen may be occluded due to the coagulation[Precautions]of the constituents and its removal from the balloon may become

Carefully apply to the following patients;[1] Confirm in advance if it is applicable to cases with urethral stenosis.

impossible.][4] Cut of the catheter.

[There is a risk of damage to tissues and urethral mucosa.][Cut due to the following causes]
・Damage caused by forceps, scissors, knife or other apparatuses<Important basic caution>

・Damage due to the calculus in the patient.

[1] Make sure the stylet is located closer to the tip of the catheter than the side hole・Sudden load on the product such as self (accidental) removal.

before use.

・Excessive load on the product when peeling off the bandage etc. rapidly[The stylet may protrude from the side hole and damage the urethral mucosa.]

・Other combined causes due to the above events.

[2] Manage appropriately the catheter state during placement. If necessary, check[5] Breakage, bending, damage, or cutting of the stylet

the placement state of the catheter by fluoroscopy.

[The stylet may be broken, bent, or cut due to the following causes][The catheter lumen may be occluded due to breakage, bending, twisting,・Insertion or removal with excessive force or operation with excessive torqueurine components, stones, etc.]

・Use with a kinked catheter[Stones may cause the balloon to burst or natural leaks may cause the balloonto shrink.]

・Other combined causes due to the above events.
[6] Valve breakage / leakage.

[There is a risk of ulceration, perforation, etc. when the tip of the catheter[There is a possibility of valve breakage or leakage due to local highcomes into contact with the bladder wall.]frequency heating.][3] Remove all the sterile distilled water in the balloon once a week as a guide,
inject the specified volume of sterile distilled water again.

Adverse events[4] When replacing the sterilized distilled water in the balloon, remove all theThe following adverse events may be caused by the use of the product:

sterilized distilled water without additional injection, then inject the sterilized

・Urinary tract infection.

distilled water of the balloon capacity again.

・Bacillemia.

[5] Do not pinch the device with forceps too strongly.

・Urinary tract injury[May cause catheter breakage, lumen blockage, and balloon breakage.]・Bladder calculus.

[6] Metal is used for inside the valve of this product, when performing an

・Hematuria (hemorrhage)inspection by MRI (Magnetic Resonance Imaging), note that the image may

・Pyrexia

have artifacts and local high frequency heating.

・Pain・Ulceration, perforation<Use of stylet>

・Leakage of the urine from catheter side.

A stylet is attached to the catheter tube.

・Urinary incontinence after removing the catheter.

[1] Do not extend the catheter if it is broken or bent.

・Urethral edema and ulcer around the catheter.

[The stylet may break when removed.]

・Remains in the body due to catheter cutting[2] Make sure that the stylet is always attached to the tip of the catheter during
insertion.
[The stylet may protrude from the side hole and damage the urethral mucosa.][3] Since the stylet is hydrophilic, make sure the surface is wet before using.
[Lubricity cannot be maintained unless the surface is wet.]<Failures・Adverse events>
Failures[1] Balloon burst[Storage conditions and duration of use]
<Storage conditions>Store the product hygienically, avoiding the direct sun light, high humidity andultraviolet rays such as a sterilizing lamp and taking care of wetting.
< Expiration date >See the expiration date given on each package provided that the device is storedappropriately.
[By self-authentication (our data).][Burst caused by the following causes.]･ Damage caused by the handling at the insertion (damage caused byforceps, scissors, knife or other apparatuses)

Manufacturer･ Excess of the injection volume (injection of more than the specified

CREATE MEDIC CO.,LTD.
2-5-25 Chigasakiminami, Tsuzuki-Ku, Yokohama, Japanvolume)･ Injection of the wrong substance for balloon inflation (substances likely tocoagulate easily such as isotonic sodium chloride solution or contrast
media etc.)

In-house administration number: DC67862

R0-0 2020.10.26･ Damage due to the calculus in the patient.
･ Sudden load on the product such as self (accidental) removal.
･ Adhesion of the crystallized urine to the balloon.
･ Other combined causes due to the above events･ Unreasonable pulling out without slipperiness of the stylet.
[2] Occlusion of the catheter.
[The lumen of the catheter may be occluded by the adhesion of the urinary
constituents or blood clots etc.]
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