Kaishou Silicone Foley Catheter 3 Way 16FR 1’s Instructions

Kaishou Silicone Foley Catheter 3 Way 16FR 1’s Instructions

• Please read these instructions carefully before using this product.
• Keep these instructions for reference.
• In case of any serious incident please report it to the manufacturer and your competent authority.
• These instructions for use are based on experience from physicians and/or their published literature. It is intended to assist in using this device. It is not a reference to surgical techniques.

PRODUCT NAME

Silicone Foley Catheter

DESCRIPTION/INDICATIONS

The silicone foley catheter consists of a main shaft with a drainage cavity, an inflation tube which is connected to a retention balloon and a check valve to control the pressure of the balloon, and an irrigation channel (3-way catheter).
Silicone foley catheters can be divided into 2-way and 3-way foley catheters according to the quantity of channels. 3-way catheter contains an additional irrigation channel to enable irrigation. Due to different design of the irrigation channel, the 3-way catheters are further divided into Type A (without bonnet at the proximal end of irrigation channel) and Type B (with a bonnet at the proximal end of irrigation channel). According to the head shape, the silicone foley catheters are available with round head or straight head.
The silicone foley catheter is made of 100% medical silicone. They are resistant to kink and are soft enough for urinary catheterization. There are typically two side holes at patient-end of foley catheter. After inserting, the drainage lumen of the silicone foley catheter is able to drain the urine or irrigate fluids into the bladder.
Foley catheters use pressure of bladder to drain urine out through catheter. The balloon on 2-way and 3-way catheters can be inflated after water injection so that the balloon can fix the catheter during indwelling catheterization. In addition, 3-way foley catheter can also be used for bladder irrigation.
The silicone foley catheter has a stripe made from barium sulfate along the shaft. This material is radiopaque and is visible under fluoroscopy.
Based on the tube diameter, following sizes of silicone foley catheters are available: Fr6, Fr8, Fr10, Fr12, Fr14, Fr16, Fr18, Fr20, Fr22, Fr24, Fr26 for Two-way catheters and Fr16, Fr18, Fr20, Fr22, Fr24, Fr26 for three-way catheters.
The silicone foley catheter is indwelling catheter and is designed and manufactured acc. to EN ISO 20696 sterile urethral catheters for single use.
The device is delivered in a sterile state with EO sterilization. The shelf life is defined for 3 years after sterilization. A re-sterilization by users is not allowed.

Intended Purpose
Silicone foley catheter is intended for urethral urinary catheterization and drainage of the urinary bladder.

It is intended for use in adults and children, who suffers under acute and chronic urinary retention and for patients undergoing urological surgery or other surgery on contiguous structures of the genitourinary tract. Silicone foley catheters are designed with a variety of sizes and lengths for broad population groups. There is no limitation in patient population and gender. Medical condition of patients are patients who needs treatment of urinary retention, e.g. after urological surgery.

Drainage Cavity (Cavity Head); 2. Inflation Tube; 3. Check Valve; 4. Retention Balloon

Drainage Cavity (Cavity Head); 2. Inflation Tube; 3. Check Valve; 4. Irrigation Channel; 5. Retention Balloon (Irrigation channel: Type A (without bonnet); Type B (with a bonnet at the proximal end of irrigation channel)).

Figure 1 Drawings of Silicone Foley Catheter

SPECIFICATION

Table 1 Types and Dimensional Specifications of Silicone Foley Catheters

2-way Catheter

Size| Balloon volume (ml)| Check Valve Color| Effective Length (mm)
---|---|---|---
Fr| Outer Diameter (mm)| Tolerance (mm)
6| 2.0| ±0.33| 3| Pink| 250±5%
8| 2.7| Light blue
10| 3.3| Black
12| 4.0| 5~10| White
14| 4.7| Green
16| 5.3| Orange
18| 6.0| Red| 340±5%
20| 6.7| 10~20| Yellow
22| 7.3| Purple
24| 8.0| Blue
26| 8.7| Pink

3-way Catheter

CONTRAINDICATIONS

The silicone foley catheter is contraindicated for untreated urinary tract infection.
The device should not be used for patients with silicon allergy.

CAUTIONS and WARNINGS

• Carefully read all instructions prior to use. Observe all warnings and cautions. Failure to do so may result in injury.
• Inspect the integrity of the packaging before use. Do not use if package is open or damaged.
• Upon removal from the package, inspect the product to ensure no damage has occurred.
• The use of this product is restricted to a qualified physician with adequate training and knowledge of these procedures.
• Suitable size of foley catheter must be chosen appropriately on basis of patients’ situation.
• Check the foley catheter is excellent without damage, the balloon should not have air nor liquid leak, aspiration should not be unobstructed.
• If use 3-way foley catheter, please also check the irrigation channel is unobstructed before using.
• When using catheter, operator must follow medical standards of hospital and product instruction manual.
• Only use water based lubricants or gels. Petroleum base lubricant should not be used, e.g. vaseline, liquid paraffin and so on.
• The retention period of this product should not exceed 30 days.
• After use this device may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practices and with applicable local, state and federal laws and regulations.
• Silicone foley catheters are provided in sterile state and intended for use in a single procedure only. Do not re-use, reprocess or resterilize. An infection or transmission of diseases could occur, if the device were to be re-used.

POTENTIAL COMPLICATIONS

Complications which can result from the use of silicone foley catheters may include:

• Urinary tract infections.
• injury to the urethra.
• Deflating the balloon, usually too quickly, with the syringe may result in the collapsing of the catheter inflation lumen. Should this occur, seek a suitably trained medical professional for assistance.
• Damage to the bladder. Do not attempt to rupture the catheter balloon by over inflating it as this could cause further damage to the bladder. In case of rupturing, it is important that all fragments are carefully removed.
• Catheters that are not correctly positioned in the bladder may cause irritation, pain and mucosal damage especially if the balloon is inflated whilst in the urethra.
• Blockage caused by encrustation, infections or spasms affecting urinary drainage may occur.

DIRECTIONS FOR USE

1. Before using product, please perform routine disinfection to hands of operators and the parts which require using product of patients. Operators should also wear sterilized gloves.
2. Choose suitable size of foley catheter. Open the package from opening site and take out catheter.
3. When using, please lubricate the tube of foley catheter firstly then insert catheter to bladder carefully (urine should excrete now). Afterwards, insert more for another 3 to 6cm to make the balloon get into bladder completely. Hold overcoat of valve and use syringe (without syringe needle) and insert checkvalve. Inject water for injection or 0.9% sodium-chloride solution, the volume of injection should be according to balloon capacity that identified. In this case, the balloon will be inflated and stuck in bladder. Hold overcoat of valve and pull out syringe slowly. The check valve will close automatically now to keep the balloon inflated. Connect joint of foley catheter onto urine collection device.
4. When removing catheter, use syringe (without syringe needle) to insert check-valve, extract sterile water in balloon out. When the volume of water in syringe is close to the balloon capacity that identified, catheter can be pulled out slowly. Tube can also be cut off to discharge sterile water in balloon quickly, and then remove foley catheter.

STORAGE

Keep away from sunlight.
Temperature: < 35 °C
Relative Humidity: 0% to 80%

SHELF LIFE 3 years

EXPLANATION OF SYMBOLS USED ON LABELS AND INSTRUCTIONS FOR USE

Sterilized using ethylene oxide

Caution

Do not re-use

Consult instructions for use

Do not resterilize

Keep away from sunlight

Catalogue number

Keep dry

Batch code

Upper limit of temperature

Date of manufacture

Humidity limitation until 80%

Use-by date

Fragile, handle with care

Date of manufacture

Do not use if package is damaged

UDI code

Manufacturer

Medical device

Authorized representative in the European Community

Importer

Jiangsu Kaishou Medical Apparatus Co., Ltd.
No. 2-18 West Xihe Road, Sanhekou Street, Zhenglu Town, Tianning District, Changzhou, 213115 Jiangsu, P.R. China.

Luxus Lebenswelt GmbH Kochstraße 1, 47877 Willich, Germany.

Date of issue: 2021-09-01
Revision: A/0

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