Instructions for Operation

WARNING: To help reduce the potential for infection and/or other complications, do not reuse.

WARNING: If discomfort or any sign of trauma occurs, discontinue use immediately and consult your healthcare practitioner.

  • Ready-to-use, singe-use catheter system

  • Latex-free

  • Magnetic Flow Key

  • Urine drainage bag

This catheter is a flexible tubular device that is inserted through the urethra by male patients who need to drain urine from the bladder.

PRECAUTION: Please consult your healthcare practitioner before using this product if any of the following conditions are present:

  • Severed urethra

  • Unexplained urethral bleeding

  • Pronounced stricture

  • False passage

  • Urethritis – inflammation of the urethra

  • Prostatitis – inflammation of the prostate gland

  • Epididymitis – inflammation of the epididymis (testicle tube)

PRECAUTION: Self-catheterization should follow the plan of care and advice given by your healthcare practitioner and be carried out only in accordance with instructions for use provided. Because catheterization frequency varies by person, the recommended frequency of your catheterization should be provided by your healthcare practitioner. For any other questions about your catheterization, please contact your healthcare practitioner.

Instructions for Use

I. Insertion Procedure

Wash your hands.

  1. Open Insertion Kit. Apply sterile gloves.

  2. Fully fold back the packaging by peeling the clear side of the Insertion Kit. Visually inspect to ensure that all components are present and properly assembled.

    1. Insertion Kit Contents:

      1. Insertion Tool + Catheter Assembly

      2. Syringe with sterile water

    2. Pushwire is properly seated within Malecot Anchor

    3. Mating balloon is situated within valve mating chamber

    4. Syringe is locked (with removable clip) and contains water

  3. Remove the syringe from the packaging. Attach syringe to Y junction port on the hand-piece and twist to secure in place using the Luer lock mechanism.

  4. Remove the transport lock clip from the syringe plunger and fully depress syringe plunger to inflate mating balloon. Attach syringe latch to secure syringe in inflated position. Visually confirm that the balloon is fully inflated within the valve mating chamber.

  5. Advance the pushwire fully into the rear of the Insertion Tool hand-piece, and twist the Luer mechanism to lock it in place. Visually confirm that the Malecot Anchor is in its extended and collapsed position.

  6. Hold the penis. Pull back foreskin (if present) and cleanse glans and opening of urethra with mild, unscented soap or a non-alcoholic wet wipe.

  7. Apply lubricant generously to entire body of catheter and tube of Insertion Tool.

  8. Holding the lubricated Catheter Insertion Assembly gently, insert the Catheter Insertion Assembly into the urethra until it is in proper position in the bladder, as confirmed by the flow of urine through the catheter, and/or by the graduated marking on the tool’s tube. Gently advance by another 2 inches.

  9. With the Catheter in its proper position, disengage the pushwire by twisting (counter-clockwise) to release the Luer mechanism on the back of the Insertion Tool hand-piece. Retract the pushwire from the back of the hand-piece by about ½ inch to expand the anchor.

  10. Gently pull on the Insertion Tool until a slight resistance is felt, indicating the the Malecot Anchor is in its proper position at the bladder neck opening. Confirm the correct placement of the Catheter within the urethra by palpating the base of the penis.

  11. Once the correct placement of the catheter is confirmed, pull to completely remove the pushwire from the back of the hand-piece. Discared pushwire.

  12. Release the syringe latch and withdraw the plunger to deflate the mating balloon. This will disengage the tool from the Catheter valve mating chamber.

  13. Gently withdraw the Insertion Tool from the penis, leaving the Catheter in the proper position. Relax the foreskin (if present).

  14. Discard the Insertion Tool.

 

II. Bladder Voiding Procedure

  1. To empty your bladder, place the tip of your penis into the nozzle of the urine drainage bag and place the magnetic Flow Key to the base of your penis, where the catheter valve is located. Urine will begin to flow. If able, you may further assist the flow of urine by contracting your bladder.

  2. When your bladder is empty, gently shake the tip of your penis to collect all urine remaining in the urethra, and apply cap to the collection bag.

 

III. Extraction Procedure

Wash your hands.

  1. Open Extraction Kit. Apply sterile gloves.

  2. Fully fold back the packaging by peeling the clear side of the Extraction Kit. Visually inspect to ensure that all components are present and properly assembled.

    1. Insertion Kit Contents:

      1. Extraction Tool

      2. Syringe with sterile water

    2. Mating balloon is fully collapsed and contained within the tip of the Extraction Tool

    3. Syringe is locked (with removable clip) and contains water

  3. Remove the syringe from the packaging. Attach syringe to Y junction port on the hand-piece and twist to secure in place using the Luer lock mechanism.

  4. Hold the penis. Pull back foreskin (if present) and cleanse glans and opening of urethra with mild, unscented soap or a non-alcoholic wet wipe.

  5. Apply lubricant generously to tubular body of the Extraction Tool.

  6. Holding the lubricated Extraction Tool gently, insert the Extraction Tool into the urethra until the tool tip makes contact with the distal end of the valve. Confirm contact with the catheter by palpating the base of the penis.

  7. With proper alignment of the Extraction Tool and catheter valve confirmed, advance the mating balloon by sliding the pushrod to the forward position on the hand-piece, locking it in position.

  8. Remove the transport clip from the syringe, depress the syringe plunger to inflate the mating balloon. Latch the plunger in place.

  9. With the Extraction Tool mated to the catheter valve, gently pull to remove the catheter. You will feel some slight resistance at first. As you continue to pull, the Malecot Anchor will collapse and allow the catheter to be smoothly withdrawn.

  10. Discard the removed Catheter + Extraction Tool Assembly.

NOTE: Store boxes in a flat position and at normal room temperature.