Instruction For Use for All Silicon Foley Catheter

Transcription

1 General Description: All Silicone Foley Catheter for single use is a thin, is a flexible tube passed through the urethra and into the bladder to drain urine. It is the most common type of indwelling urinary catheter, ended with soft rounded closed tip with Safe and symmetrical balloon inflation. User The user s formation Charge doctor Patient with acute urinary retention. Intended Use: All Silicone Foley Catheter for single use is a thin, sterile tube inserted into bladder to drain urine. Because it can be left in place in the bladder for a period of time, it is held in place with a balloon at the end, which is filled with sterile water to hold it in place. The urine drains into a bag and can then be taken from an outlet device to be drained. All Silicone Foley Catheter 2way consist of tube has two lumens one lumen for urinary drainage which is to be connected to urine collection container, one lumen with one-way valve for inflation/deflation of Foley silicone balloon, it used for people who have mobility issues, such as quadriplegia. Insertion of All Silicon Foley catheter: The catheterization procedure varies from region to region, but the use of aseptic technique must always be practiced. *Preparation a. Explain the procedure and its purpose to the patient. Instruct him/her to breathe deeply through his/her mouth when the catheter is introduced. This is to allay anxiety besides relaxing the urethral sphincter. b. Wash the genitalia area. Ideally it should be shaved to minimize infection. C. Place the patient in the dorsal position (lying on his back) with thighs apart. d. Arrange the protective material under the patient s buttock. e. Put on sterile gloves and drape the area. *Catheterization for male patient A) Disinfection Hold the penis on one hand and clean around the urethral orifice with another using disinfectant. Use each swab once only and cleanse in a circular motion, working outward from meatus. B) Catheterization

2 Spread the external urethral orifice by hand, introduce the conical nozzle of disposable syringe into the meatus and instill lubricant by extending the penis without increasing pressure. Compress by hand the urethra for a moment to prevent the lubricant from running out. Hold the catheter by sterile forceps with the funnel end fixed between small finger and ring finger. The tip of catheter is introduced to the urethra and pushed forward by about 15cm. There will be a slight resistance when reaching the sphincter muscle which can be overcome by lowering the penis a little and slightly pushing forward the catheter. C) Urine bag On reaching the bladder, urine will drain out, as the eyes of catheter now lie in the bladder bed. Collect the urine by placing the catheter end into the urine basin. Insert the catheter a further 5cm into the bladder, positioned at the neck of the bladder. To empty the bladder thoroughly, one can apply slight pressure on the lower abdominal region above the pubic bone using the palm. the catheter attach with the urine bag. Complete procedure by drying the genitalia and then taping it to prevent traction. *Catheterization for female patient The procedure is almost similar with that of male patient. A) Disinfection Clean the genitalia from the clitoris downwards to the vagina to prevent contamination of urethral orifice by faeces or vaginal discharge. Clean using separate swabs each time, the labia majora then labia minora and down the center over the urinary meatus. Separate the labia with fingers of one hand while cleaning using another until the whole procedure is completed. B) Catheterization Holding labia apart, instill lubricant and introduce catheter into the urethral orifice and slowly push forward. On reaching the bladder the urine will drain off. Push catheter forward about another 5cm. Then gently pull back catheter to position it on neck of the bladder. C) urine bag On reaching the bladder, urine will drain out, as the eyes of catheter now lie in the bladder bed. Collect the urine by placing the catheter end into the urine basin. Insert the catheter a further 5cm into the bladder, positioned at the neck of the bladder. To empty the bladder thoroughly, one can apply slight pressure on the lower abdominal region above the pubic bone using the palm.

3 the catheter attach with the urine bag. Complete procedure by drying the genitalia and then taping it to prevent traction Material: All Silicone Foley Catheter consists of flexible tube made of 100% Silicone. Indications: Include providing relief when there is urinary retention, monitoring urine output for critically ill persons, managing urination during surgery, and providing end-of-life care. All Silicone Foley catheters are used during the following situations:... On patients with acute urinary retention. Connection with other medical device All silicon Foley catheters is connected and compatible with urine collection bag Warning: Do not use ointments or lubricants having a petrolatum base. They will damage the catheter visually inspect the product for any imperfections or surface deterioration prior to use. Inflate the balloon with sterile water to the volume stated on the inflation lumen of the catheter by using a water-filled Luer tip syringe. Do not use needle. Do not exceed recommended capacities.

4 This is a single use device. Do not resterilize any portion of this device. Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient. - Do not use by unskilled and untrained personnel Precautions: To deflate catheter balloon: Gently insert a Luer slip tip syringe in the catheter valve. Never use more force than is required to make the syringe stick in the valve. Allow the pressure within the balloon to force the plunger back and fill the syringe with water. If you notice slow or no deflation, re-seat the syringe gently. Use only gentle aspiration to encourage deflation if needed. Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation. If necessary, contact adequately trained professional for assistance, as directed by hospital protocol. Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient. Packaging Artwork and Label Artwork: Package description Single unit sterilized by EtO gas placed in single Pouch made of PE/PP & Medical Paper, then each 20 unit are packed in small box then Each 40 boxes are packed in master carton.

5 TYPE AND SIZE # Product Ref. No. Device GMDN Code All Silicone Foley Catheter (size 6) All Silicone Foley Catheter (size 8) All Silicone Foley Catheter (size 10) All Silicone Foley Catheter (size 12) All Silicone Foley Catheter (size 14) All Silicone Foley Catheter (size16) All Silicone Foley Catheter (size 18) All Silicone Foley Catheter (size 20) All Silicone Foley Catheter (size 22) All Silicone Foley Catheter (size 24) All Silicone Foley Catheter (size 26) Storage Condition The Temperature limit from -10 C to 40 C Sterilization: All Silicone Foley Catheter is sterilized by Euromed for Medical Industries. EtO sterilization, biological indicator testing and aeration process are performed by Euromed for Medical Industries Company.

6 Symbol: Euromed For Medical Industries Area No. (10), Block (i), Nasr City, Cairo, Egypt 0120 Tel: /3 MDSS GmbH Schiffgraben Hannover, Germany

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