Self-Catheterization Set(Pure Cath)<Dimensions>- Catheter[Warning]
This device must be used after it has been disinfected using anappropriate antiseptic solution of right concentration.
[It is a non sterilized product.]

Size
9 Fr
12 Fr
12Fr Hard Type
14 Fr

[Contraindications / Prohibitions]・Do not use in patients with urethral stenosis.
[Otherwise, it may damage tissues and/or urethral mucosa.]
・Do not resort to sterilization and/or boiling to the catheter case,cap and outer case.
[Otherwise, it may deform the device and impair the intendedfunction.]・This device is intended for the use in women, and should not be
used in men because the length is too short.
[The length of the portion of this device inserted into the patientbody is approx. 110 mm.]・In case that insertion of this catheter could not allow the patient tourinate, do not use the device.
[For some patients, the length of this catheter may be too short. In
addition, patient’s urine may not run through the catheter due tothe urine condition.]・Do not use any other catheter to apply in the case of this productthan the one that is preset.
[Otherwise, it may lead to a difficulty to close the case cap or totake out the catheter.]・After opening the package, the device must be replaced when it
passed the shelf life. Do not keep using the catheter unit or thecase together with other new components.
[Otherwise, the catheter may be degraded and result in breaking
and/or urination disability.][Otherwise, the case may be degraded and result in leakage and/orbreakage.]

Tip

Catheter shaft

Main body of caseFeature

125mm

2 sideholes[Intended Usage]
The device is to be inserted temporally into the urethra, bladder, ordrainage port after urinary diversion surgery to be used for urination.
[Effect]
Can be inserted into the urethra, bladder, or drainage port after urinary
diversion surgery and lead to temporary urination.
[Performance]
・Do not contain materials of biological origin and be compatible withbiological safety.
・Can withstand 29 days of reuse.
・To be stable and durable for 5 years.
・It doesn't cut when stretching both ends of this product with the following loadin the length direction.
O.D. 2-4mm：10N, O.D.≧4mm：20N[Operation Procedure]
A typical operation procedure is described below:

Connector<How to prepare>
1) Twist and open the case cap (Figure 1) to take out the catheter. (Thefit of the case cap and the main body of case is designed for theoccasions in which they are wet with antiseptic solution. It might berather tight just after the first opening.)
2) Fill the main body of case with an antiseptic solution of rightconcentration. The solution should be poured into the main body ofcase to the level just above the porthole of the case (approx. 5.5 mL)(Figure 2).
3) Put the connector of the catheter into the inside of the case cap(Figure 3).
4) Insert the catheter into the main body of case. Put in the head of thecase cap on the main body of case until it clicks (Figure 4), and see
the confirmation mark to make sure that the main body of case andthe case cap fit completely. (Figure 5)5) Wipe off the moisture on the surface of the case.

Side holes・Cathter Case

Total length<Principals>
Take out the catheter from the case filled with antiseptic solution, andperform self catheterization. After each self catheterization, the usedcatheter can be cleaned and housed in the case for the purpose ofstorage and carrying around.

[Shape, Structure, and Brief Description on the Usage, etc.]<Shape>・Catheter

Outer
diameter
3.0 mm
4.0 mm
4.0mm
4.7 mmCase Cap

Strap (detachable)
Hook (detachable)
・Outer Case

<Material>
Silicone rubber

1／3

Casecap
ケースキャップ

The level up towhich antiseptic
solution is filled.

Twist
ひねる

消毒液注入の目安

Mainbody of
ケース本体
case(Figure 1)（図１）3) Do not rub the main body of case, case cap, strap, and/or hook too
strongly when wiping off the antiseptic solution on them. Do notwipe off this product using alcohol for disinfection.
[Otherwise, the printing made on the case may be erased or thedevice may have a crack or tear.]4) When put the connector of the catheter into the inside of the casecap, push the connector until it is fixed firmly.
5) After closing the case cap, make sure that the main body of caseand the case cap fit completely, and that antiseptic solution does
not leak from the case. (See Figure 5 in <How to prepare>.)[If the main body of case and the case cap do not fit completely,
antiseptic solution may leak.]6) Do not pull the hook or the strap strongly or apply excessive load.
[The hook and the strap are only for the use of hanging the main
body of case during urine drainage.]7) When hanging the main body of case with the hook, choose theposition where the hook can be placed firmly, and release hand
after it becomes stable.
[Otherwise, antiseptic solution may spill out and/or the main bodyof case may fall and result in breakage.]8) If a patient could not insert catheter into her(user) urethral orifice
appropriately, tell her not to insert it forcibly but to insert it slowly
in a relaxed state, breathing deeply. (Insertion may be easier whena patient has an image that her urethra is opening by itself.)9) When the catheter is inserted with the case cap being attached,urine will leak from the case cap. (The case cap does not seal off
the catheter completely.)

Porthole窓(Figure 2)（図２）＊Case cap
ケースキャップ
Connector
コネクター(Figure 3)（図３）* Put the connector into the case cap
until it is fixed firmly.
※コネクターが止まる位置まで、しっかりと押し込むこと。

Put押し込むin thecase cap.
(Figure 4)（図４）

Confirmation mark(Figure 5)（図５）＊

位置合わせマーク<How to perform self catheterization (instructions to be given topatient)>
1) Wash hands, or clean hands with towelette or purity cotton.
2) Pull down garment and underpants, and take an appropriate
posture to drain urine.
3) Widen vulva in one hand, and wipe urethral orifice from anterior toposterior using another hand with a purity cotton.
4) Twist and open the case cap to take out the catheter.
5) With the case hook, hang the main body of case from anappropriate position (e.g. the doorknob inside the bathroom, theaxis of the bathroom paper holder).
6) When needed, apply a lubricant agent to the tip of the catheter.
7) Widen vulva in one hand, take the catheter using another hand in away like when holing a pencil, and insert it to urethral orifice. Be
sure to take off the case cap beforehand.
8) After draining urine, pull the catheter slowly, and take it out frombody when urine is drained completely.
9) After use, clean the catheter with tap water, and house and store it
within the case according to the steps 3) to 5) of <How toprepare>.

[Precautions]<Important general instructions >1) Before using this product, please provide right instructions to thepatient. Especially, for a disabled person, child, the elderly, or theothers who cannot perform opening/closing of the case and/orcatheter insertion appropriately, explain and give instructions in a
careful and understandable 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) Do not wipe off this product using alcohol for disinfection.
[Otherwise, the printing made on the case may be erased or thedevice may have a crack or tear.]3) If the device does not function as a catheter for self catheterization
due to the reasons such as clogging or contamination caused byaging, it should be replaced with a new device for selfcatheterization even if it is within the shelf life, based on thephysician’s judgment.
4) Before using this product, check every component for anyabnormalities.
5) Do not insert the catheter forcibly. If there is difficulty in insertion,stop the use. Do not pull or bend the catheter forcibly.
[Otherwise, it may harm the patient’s tissues.][Otherwise, it may cause damage of the product.]6) If there is any abnormality, stop the use immediately and takeappropriate measures.
7) Do not modify the product.
[If any feature (e.g. side hole(s)) is added, it may cause breakage ofthe catheter.]8) Do not expose this product to an organic solvent, strong acid,strong base, or any equivalent agent.
9) Do not hold this product strongly with forceps or other tools.
[Otherwise, it may cause a tear of the catheter or clogging in thelumen.]<Precautions related to the operation procedure>
1) Do not open or close of the case cap / the main body of caseforcibly. Do them slowly referring to Figures 1 and 4.
2) If an antiseptic solution is poured into the main body of case when
it is tilted, or if the catheter is put into the main body of case inwhich antiseptic solution is filled too much, the antiseptic solution
may spill out. In case the antiseptic solution spilled out, wipe off
the moisture on the main body of case and the case cap before theirstorage.
[If the antiseptic solution is not wiped off completely, the residual
antiseptic solution might seep through the bottom of the main bodyof case, as if there is a leakage of antiseptic solution.]

2／310) In case of any abnormality including damage in the package or thedevice, do not use the product.
11) Use the product soon after the package is opened and dispose theused product in a secure manner for each country.
12) Whenis found on the label, it means that the product should
not be used if the package has been damaged or opened.
13) Whenis found on the label, it means the product Doesn’t
contain DEHP in the contact part with body fluid and drugsolution.
14) Any serious incident that has occurred in relation to the device
should be reported to the manufacturer and the competent authorityof the Member State in which the user and/or patient is established.

for the patient. Below provides the drug names and the reference
concentration for use, for information. However, the concentrationmust be decided considering the patient conditions based on thephysician’s experiences.
General name

Reference
concentration for use

sodiumhypochlorite

0.0125～0.02％

Usage experience
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 device may be colored depending on the disinfectant used.

<Failures>
By using this product, the following failures might occur:- If the device is not cleaned or disinfected appropriately, the lumen of
the catheter may be clogged, or catheter may be colored or degraded.
- If opening or closing the main body of case / the case cap is done
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 resultin a breakage of the case or a release of the strap. Also, the case cap
may be loosened and antiseptic solution may leak out.
- If the main body of case and/or the case cap are kept withoutcompletely wiping off the moisture on them, decoloration may occur.
- If the main body of case, case cap, strap, and/or hook is rubbed toostrongly when wiping off the antiseptic solution on them, it may
result in a paint detachment or breakage.

2) It is recommended to exchange antiseptic solution once daily. If
the device is not used for long time, dry it completely before
storage. In such cases, do not use the device after it passed the shelf
life after opening.

DC61646 (MDR 1st Edition) Prepared on January 7, 2021

<Adverse events>By using this product, the following adverse events may occur:- Urethralgia or distress during catheter insertion at initial period of selfcatheterization.
- Urinary tract infection such as cystitis or pyelonephritis.
[In the case of having a small urinary volume every day or adifficulty in keeping herself clean.]- Urethral injury, hemorrhage.
- Leakage of antiseptic solution. (If the main body of case and the casecap do not fit completely, it is easier to result in a leakage of antiseptic
solution especially while being on board the flight due to changes inatmospheric pressure.)[Method of Storage and Shelf Life]<Method of storage>
This product must be stored under clean conditions and prevented fromdirect sunlight, high temperature and humidity, low temperature below
10˚C, and ultraviolet ray including a sterilamp.
<Duration of use>
This product is recommended to be replaced with a new device within
1 month.
[Self-certification (based on in-house data).]<Expiration date>･ See the expiration date given on each package provided that thedevice is stored appropriately.
[Self-certification (based on in-house data).]･ Store the device carefully and never use the device after theexpiration date.
【The matters pertaining to the maintenance and inspection】<Maintenance and inspection items by the user>
1) Prescribe an appropriate antiseptic solution of right concentration
3／3