Tierrett Foley Catheter
Instructions for use
Contraindicated to re-use[9] Fix the catheter to the skin with a bandage etc.

[CONTRAINDICATIONS・PROHIBITION]
Do not reuse the product (single use only).

[10] If necessary, put the catheter urine outlet with the cover (small) on the cover(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, structure, principle]
This product is sterilized with ethylene oxide gas.

slowly lift the cover (small) knob.
[11] When removing the catheter, suck the sterile distilled water of the balloon<Shape>with a syringe to shrink the balloon and slowly pull out the catheter.
<Precautions for the using method>[1] Do not to touch the valve fixing ring.

Valve fixing ring
Catheter

Valve

Balloon5

Side hole

Urine outlet[The fixing ring may come off and the valve may fall off.][2] Please note the following when inflating and deflating the balloon.

Styletﾊﾞﾙｰﾝ容量 *mL

Tip(radiopaque)

1) Use only sterile distilled water to inflate the balloon.

Cover(large)[When saline, contrast medium, etc. are used, the components may
coagulate and water may not be removed.]

Cover(small)

2) Use a general slip-type disposable syringe to inflate or deflate the balloon.
[With a lock type syringe, it is impossible to insert very inside of the valve. If
the taper does not match, the valve will be damaged.]・Transparent type
Size

O.D.

6Fr
8Fr

2.0mm
2.7mm

Total
length340mm
340mm

Recommended
balloon capacity
1mL
3mL3) When inflating and deflating the balloon, make sure to insert very inside ofthe valve and perform the operation.
[If the tip of the syringe is not inserted very inside of the valve, the insidevalve 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: Polyamide

5) Do not inject more than the specified volume of sterile distilled water into
<Principles>the balloon.

By injecting sterile distilled water from the valve with a syringe, the balloon[Excessive injection will overload the balloon and cause a burst.]

inflates and can be placed. By sucking the injected sterile distilled water, the6) When removing the syringe, make sure to press the valve and rotate thesyringe to remove.

balloon shrinks and can be removed. Urine is discharged from the side hole

[The valve may off and sometimes come off.]

through the lumen to the urine outlet.

[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 select[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.

the 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 a[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.]

lubricant 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 doubtthat 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.

[If using a bandage with strong adhesiveness for a small-diameter catheter[8] Remove the stylet slowly. If the urine is left without confirmation of outflow,

when peeling off, the catheter may be overloaded and cut.]

inject sterile distilled water into the catheter and carefully remove because theinside of the catheter is dry and the stylet is difficult to remove.
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[Precautions][Cut due to the following causes]

Carefully apply to the following patients;

・Damage caused by forceps, scissors, knife or other apparatuses[1] Confirm in advance if it is applicable to cases with urethral stenosis.

・Damage due to the calculus in the patient.

[There is a risk of damage to tissues and urethral mucosa.]

・Sudden load on the product such as self (accidental) removal.
・Excessive load on the product when peeling off the bandage etc. rapidly<Important basic caution>

・Other combined causes due to the above events.

[1] Make sure the stylet is located closer to the tip of the catheter than the side hole[5] Breakage, bending, damage, or cutting of the stylet

before use.

[The stylet may be broken, bent, or cut due to the following causes][The stylet may protrude from the side hole and damage the urethral mucosa.]

・Insertion or removal with excessive force or operation with excessive torque[2] Manage appropriately the catheter state during placement. If necessary, check

・Use with a kinked catheter

the placement state of the catheter by fluoroscopy.

・Other combined causes due to the above events.

[The catheter lumen may be occluded due to breakage, bending, twisting,[6] Valve breakage / leakage.

urine components, stones, etc.][There is a possibility of valve breakage or leakage due to local high[Stones may cause the balloon to burst or natural leaks may cause the balloon

frequency heating.]

to shrink.][There is a risk of ulceration, perforation, etc. when the tip of the catheter

Adverse events

comes into contact with the bladder wall.]

The following adverse events may be caused by the use of the product:[3] Remove all the sterile distilled water in the balloon once a week as a guide,・Urinary tract infection.

inject the specified volume of sterile distilled water again.

・Bacillemia.

[4] When replacing the sterilized distilled water in the balloon, remove all the・Urinary tract injury

sterilized distilled water without additional injection, then inject the sterilized

・Bladder calculus.

distilled water of the balloon capacity again.

・Hematuria (hemorrhage)[5] Do not pinch the device with forceps too strongly.

・Pyrexia[May cause catheter breakage, lumen blockage, and balloon breakage.]・Pain[6] Metal is used for inside the valve of this product, when performing an・Ulceration, perforation

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

・Leakage of the urine from catheter side.

have artifacts and local high frequency heating.

・Urinary incontinence after removing the catheter.
・Urethral edema and ulcer around the catheter.

<Use of stylet>・Remains in the body due to catheter cutting

A stylet is attached to the catheter tube.
[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.

[1] Do not extend the catheter if it is broken or bent.
[The stylet may break when removed.][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.]< Expiration date >See the expiration date given on each package provided that the device is stored
appropriately.

<Failures・Adverse events>
Failures[By self-authentication (our data).][1] Balloon burst[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

In-house administration number: DC67875

media etc.)

R0-0 2020.10.27･ 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[2] Occlusion of the catheter.
[The lumen of the catheter may be occluded by the adhesion of the urinary
constituents or blood clots etc.][3] Impossibility of the catheter removal.
[If the isotonic sodium chloride solution or contrast medium is used for theballoon inflation, the balloon lumen may be occluded due to the coagulationof the constituents and its removal from the balloon may become
impossible.][4] Cut of the catheter.
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