Intended Use: 
The Disposable Silicone Foley Catheter is intended used for bladder drainage for urological use only.
It is sterile, single use and intended to be used by trained and experienced professionals.

Indications for Use:
The Disposable Silicone Foley Catheter is indicated for use of drainage of urine, which is accomplished by inserting the catheter through the urethra and into the bladder. It can relieve acute or chronic urinary retention or bladder outlet obstruction.

Disposable Silicone Foley Catheters comply with the Medical Device Directive 93/42/EEC.

The product should not be used if the patient has a known allergic reaction towards silicone.

Warning and Precautions:
1) Any use other than stated indications is under the responsibility of the physician.
2) Use water soluble lubricants only. Do not use ointments or lubricants having a petrolatum base. They will damage catheter’s material and may burst balloon.
3) Dwelling time depends on medical staff and patient conditions but maximum retention time should not more than 30days.
4) Do not inflate the balloon beyond the maximum value indicated.
5) Do not clamp the catheter. Use a plug if necessary.
6) Please strictly perform aseptic operation when using. Only normal saline or sterile water for injection can be injected into the air bag, and the amount of water injected shall not exceed the marked capacity.
7) The balloon must be completely deflated before catheter removal.
8) Do not use if the package has been previously opened or damaged.
9) Do not use if the product after expiry date. 
10) The catheter should be inserted gently to avoid damaging the urethral mucosa. Do not insert too deep or too shallow, especially do not repeatedly twitch the catheter.
11) If the bladder is overfilled and the patient is extremely weak, urination should be slow. The first urine release should not exceed 1000ml to avoid bleeding or syncope caused by sudden decompression of the bladder.
12) When indwelling catheter, the fixation of catheter should be checked frequently to see if it is out. If the urethra relaxes for several hours before reinsertion, wash the bladder with sterile liquid once a day if necessary to avoid urethral infection.
13) Regularly check whether the connection between urinary catheter and urine bag is reliable.
14) Observe the color, character and excretion of urine. Keep the catheter unobstructed to avoid distortion, compression and blockage.
15) When pulling out the catheter, you can insert an empty syringe into the one-way valve according to the water injection method to let the water discharge naturally, or cut off the piston to discharge naturally and then pull out. If there is resistance, do not forcefully pull out, otherwise the urethra will be damaged.
16) Discard after single use. Reuse of this single use product may create a potential risk to the user. Reprocessing, cleaning, disinfection and sterilization may compromise product characteristics which in turn create an additional risk of physical harm to or infection of the patient.
17) Disposal of the device shall be made in accordance with applicable national regulations for biological hazardous waste.
18) If there any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
19) The catheter is detectable by X-ray. 
20) The catheter is not compatible with MRI.
21) The intended patients of the device are both pediatrics and adults who needs bladder drainage. Always ensure the correct type and size of catheter is chosen depending on the patient and indication.