Self-Catheterization Set
Self-Catheterization Set
Self-Catheter

Catheter[WARNINGS]
The product must be used after it has been disinfected using anappropriate disinfectant of right concentration.
[The product is a non-sterilized. ]TypeC.U.R.
Type[CONTRAINDICATIONS/PROHIBITIONS]・Do not use the catheters other than Tieman Type for any case withurethral stenosis.
[It may harm the patient’s tissues as well as urethral mucous
membrane.]・Do not sterilize and/or boil the Catheter case.
[Otherwise, it may deform the product and impair the intendedfunction.]

TypeFemale
TypeMaleType[SHAPE, STRUCTURE AND PRINCIPLE]<Shape>- Catheter Case

- Catheter- Cap

HookMale-L
TypeFunnel
Catheter tube

Pediatric
TypeSide holeTip* The Catheter case, Cap and External case are not provided for Self
Catheter.
< Raw materials >Silicone Rubber

Female
TypeMaleType

Male-LType

Pediatric
TypeTieman
TypeShape395mm

5 side holes

Catheter
Depth markExternal case
Measurement

Depth marks at 10mmintervals between 10mm
to 100mm from the tip

60×117×15mm

Depth marks at 10mmintervals between 50mm
to 200mm from the tip.

60×190×15mm

Depth marks at 10mmintervals between 50mm
to 250mm from the tip.

60×232×15mm

9Fr<Principle>
Take out the catheter from the case filled with disinfectant and perform selfcatheterization. After each self catheterization, the used catheter can be cleaned
and housed in the case for the purpose of storage and carrying around.
Also, it is possible to fold the case when carrying around.

<Specifications>

10Fr
12Fr
14Fr
16Fr
10Fr
12Fr
14Fr
16Fr
10Fr
12Fr
14Fr
16Fr
18Fr
20Fr

Outer
diameter
3.3mm
4.0mm
4.7mm
5.3mm
3.3mm
4.0mm
4.7mm
5.3mm3.3mm
4.0mm
4.7mm
5.3mm
6.0mm
6.7mm

9Fr
12Fr
14Fr

Size

Size
10Fr
12Fr
14Fr
16Fr
10Fr
12Fr
14Fr
16Fr
10Fr
12Fr
14Fr
16Fr
18Fr
20Fr

Total Length

Depth marks at 10mm
60×190×intervals between 10mm
15mm
to 200mm from the tip.
Depth marks at 10mm
12Fr
Tieman60×190×intervals between 50mm
Type
15mm
14Fr
to 200mm from the tip.
14Fr
Depth marks at 10mm
16Fr
C.U.R.
intervals between
60×232×Type
15mm
18Fr
100mm to 250mm fromthe tip.
20Fr
Note) C.U.R. : Continent Urinary Reservoir(Special catheter for substitutional urinary bladder)- Outer Case

Depth markTypeSize
14Fr
16Fr
18Fr
20Fr

Outerdiameter
4.7mm
5.3mm
6.0mm
6.7mm

Catheter
Total
Length

Shape

165mm

1～4 sidehole(s)300mm

1～4 sidehole(s)

350～
395mm

1～4 sidehole(s)

3.0mm

265mm

1 side hole

4.0mm
4.7mm

300mm

1 side hole
Tieman tip[INTENDED USE]
The product is to be inserted into the patient’s urethra, bladder, or
drainage port temporally after urinary diversion surgery to be used forurination.
[EFFICACY OR EFFECT]The product is to be inserted into the patient’s urethra, bladder, ordrainage port after urinary diversion surgery, and can be used for
temporary urination.
[PERFORMANCE]・Do not contain materials of biological origin and be compatible withbiological safety.
・Can withstand reuse for 29 days.
・To be stable and durable for 5 years.

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・It doesn't cut when stretching both ends of the product with the following load in
the length direction.
O.D. 2-4mm：10N, O.D.≧4mm：20N[OPERATING AND USING METHOD]
The general operational procedure is described below.
1) Straighten the catheter case and fill the catheter case with adisinfectant of right concentration. See the following drawing astarget amount of solution (Figure 1).

(Picture. 1)[PRECAUTIONS IN USE]
<Important basic precautions>1) Before using the product, provide right instructions to the patient.
Especially, for a disabled person, child, the elderly, or the others who
cannot perform opening/closing of the case and/or catheter insertion
appropriately, explain and give them instructions in a careful andunderstandable manner. In addition, make the patient’s family
member(s) and/or caretaker(s) have a good understanding to ensure
their cooperation and assistance.
2) Before using the product, check whether there is any abnormality ineach part.
3) Do not insert and withdraw the catheter forcibly. If there is difficulty
in insertion, stop the use. Do not pull or bend the catheter forcibly
when using it.
[Otherwise, it may harm the patient’s tissues.][Otherwise, it may cause breakage of the product.]4) If there is any abnormality, stop the use immediately and takeappropriate measures.
5) Do not modify the product.
[If a side hole, etc. is added, the catheter may be cut.]6) Do not expose the product to an organic solvent, strong acid, strong
base, or any equivalent agent.
7) Do not grip the product strongly with forceps, etc.
[Otherwise, it may cause a tear of the catheter or obstruction in thelumen.]
8) Do not use if the packaging is damaged or if any abnormality such as
damage is found in the product.
9) Use the product appropriately after opening and dispose it in a safemanner for each country after replacing with a new product.
10)
printed on the label means that the product should not be
used if the package is damaged or opened.
11)
printed on the label means that the product does not containphthalic acid in the contact part of the body fluid/drug solution.
12) Any serious incident that has occurred in relation to the productshould be reported to the manufacturer and the competent authorityof the Member State in which the user and/or patient is established.

Female Type 10Fr
Male L Type 10Fr
Female Type 12Fr
Line Ⅰ for
Male Type 10Fr
Male L Type 12Fr
Pediatric Type
Female Type 14Fr
Female Type 16Fr
5mm lower than line Ⅰ for Male
L Type 14Fr
CUR Type 14Fr
5mm upper than line Ⅰ for

Middle line between Ⅰ and Ⅱ forFigure１

Male L Type 16Fr
CUR Type 16Fr

5mm upper than line Ⅱ for CUR Type 18Fr
Male Type 12Fr
Male L Type 18Fr
Line Ⅱ for
Tieman TypeCUR Type 20Fr
Male Type 14Fr
5mm lower than line Ⅱ for
Male L Type 20Fr
10mm lower than line Ⅱ for Male Type 16Fr2) Push the cap into the funnel until the chase of the cap places at thesecond lib of the funnel in order to fix firmly. (Figure 2).
Push the cap into thefunnel until the chase ofthe cap places at the
リブ２段目にキャッsecond lib of the funnel
プの溝を位置させる。
in order to fix firmly.
溝ChaseLib

リブ

Figure 2(図２)3) Straighten the catheter case and insert the catheter with cap into thecatheter case. Turn the cap surely and lock it in firmly. And makesure that disinfectant is not leaked from the catheter case.
4) Pull out the catheter and take urination procedure.
5) After use, clean the catheter with tap water. And then, house andstore it into the catheter case in accordance with the steps 2) to 3).
6) After folding the catheter case and keeping the folded form by hook,put it in the External case.
<Precautions in use related with the method of use>
1) When attaching the cap into the funnel of catheter, insert the cap to
the specific position (See figure 2). In addition, when closing thecatheter case and cap, be sure to turn the cap securely to fix it firmly.
[Leakage of disinfectant may occur]
2) Insert the catheter into body after uncapping. Attach the cap to thecase and screw it lightly or put it at clean place.
3) When it is difficult for patients to insert the catheter into the urethral
opening, instruct the patients not to insert the catheter forcibly and toinsert it slowly while relaxing and taking a deep breath. (Theinsertion may be easier, if the patients imagine opening the urethra
by themselves.)
4) Bend the funnel of the catheter and pinch the part with clothespin or
the like when stopping flow of urine at the insertion (See image 1).
Do not use clothespin with sharp edge or do not pull the clothespin
when detaching it.
[It may cause breakage of the product or obstruction of the lumen.]<Defects>
By using the product, the following defects might occur:・If the product is not cleaned or disinfected appropriately, the lumen of
the catheter may be obstructed, colored, or degraded.
・If the main body of catheter case and the cap are attached ordetached forcibly, it may result in a breakage of the case.
・If the product is fallen or hit while it is carried or stored, it may
result in a breakage of the case or a release of the hook. Also, thecase cap may be loosened and disinfectant may leak out.

<Adverse events>
・Urethralgia or distress during catheter insertion at initial period ofself-catheterization.
・Urinary tract infection such as cystitis or pyelonephritis.
[In the case of having a small urinary volume every day or adifficulty in keeping herself /himself clean.]・False passage (In case of male)[Forcible catheter insertion]
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・Leakage of disinfectant.

[STORAGE METHOD AND DURATION OF USE]
<Storage method>Store the product cleanly. Avoid direct sunlight, high temperature andhumidity, low temperature below 10℃ and ultraviolet rays such as
germicidal lamp, etc.
<Duration of use>
The product is recommended to be replaced with a new device within
29 days.
[Self-Certification (based on in-house data).]<Expiration date>･ When the proper storage method has been maintained, refer to the
expiration date on the individual package.
[Self-Certification (based on in-house data).]･ Store the product with great care, and do not use if it passed theexpiration date
【Items on maintenance and inspection】<Items for maintenance and inspection by users>
1) Prescribe an appropriate disinfectant of right concentration for thepatient. Drug names and the reference concentration for use areprovided below for information. However, the concentration must bedecided considering the patient conditions based on the physician’s
experiences.
Generic name

Reference
concentration for use

sodiumhypochlorite

0.0125～0.02％

Example of use
Dilute “Milton” 50 to 80 times
with water.

General name
Reference concentration for use
Benzalkonium chloride solution
0.05 ～0.1％
Benzethonium chloride solution
0.05 ～0.1％
Note) The product may be colored depending on the disinfectant used.
2) It is recommended to exchange disinfectant once daily. If the productis not used for long time, dry it completely before storage. In suchcases, do not use the product after it passed the duration of use afteropening. If the product is not used for a long period of time, do notbend the case and store it straight.

DC61484 ( MDR -2 ) 2023.11.1

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