MEDIKIT SUPERCATH 5 Safety I.V Catheter Instruction Manual

June 16, 2024
MEDIKIT

MEDIKIT SUPERCATH 5 Safety I.V Catheter

MEDIKIT-SUPERCATH-5-Safety-Catheter-product

Read this user manual carefully before using the device. Federal law (USA) restricts this device to sale by or on order of a physician.

INDICATIONS

  • The SUPERCATH 5 is intended to access a vein or artery and to administer fluids.
  • The SUPERCATH 5 is designed for single use and short-term use (less than 30 days), is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks.

DESCRIPTION

The introducer needle is retracted into the safety cover to minimize and reduce needlestick injury. The outer catheter has a built-in check valve, which together with the healthe are professional’s finger pressure, assists to reduce blood flashback when the introducer needle is withdrawn following blood vessel puncture. The built-in check valve is not intended to stop bleeding completely. The 18G, 20G, 22G & 24G introducer needle has a side-notch to provide rapid visual confirmation of vessel entry. When the introducer needle is inserted into the blood vessel, blood flows up and through the side-notch and returns down along the inside of the catheter tube.

MEDIKIT-SUPERCATH-5-Safety-Catheter-fig-

< Without Wing>

MEDIKIT-SUPERCATH-5-Safety-Catheter-fig-

  • Not made with natural rubber latex.
  • This product does not contain or have presence of Bis(2-ethylhexyl)phthalate (DEHP).

< With Wing>

MEDIKIT-SUPERCATH-5-Safety-Catheter-fig-3

  • Not made with natural rubber latex.
  • Bis(2-ethylhexyl)phthalate (DEHP) materials are not in the fluid pathway; only contained in the catheter wing.

WARNING

  • Resterilization, reuse, or reprocessing can cause contamination of the device, whichmay lead to infection of the patient or cross infection.
  • Do not resterilize, reuse or re-process. FOR SINGLE USE ONLY. Rester ilization,  reuse, or reprocessing can cause contamination of the device, which may lead to infection of the patient or cross infection.MEDIKIT-SUPERCATH-5-Safety-Catheter-fig-4

PRECAUTIONS

  • Use caution when handling the SUPERCATH 5 and maintain proper aseptic technique during insertion, withdrawal, and disposal as well as when the catheter is in patient use.
  • Do not move the introducer needle forwards or backward in the catheter before use or during puncture.
  • Do not reinsert a partially or completely withdrawn catheter.
  • Please refer to your facility protocols for appropriate use intervals.
  • If you fail to secure blood vessel access, use a new catheter to puncture the vessel again.
  • Take care not to press the activation button accidentally before use or during puncture.
  • Do not use if the package is wet, opened, dirty, or damaged.
  • Open the package immediately before use. Use soon after the package is opened
  • Discard properly after use.
  • Perform all manipulations aseptically.
  • Do not use sharps such as scissors near the catheter.
  • The SUPERCATH 5 should only be used by healthcare professionals familiar with catheterization techniques.
  • Do not use for purposes other than those intended.• Store the SUPERCATH 5 in a dry (humidity below 75%), dark (avoid direct sunlight), room-temperature (60-80 °F) cabinet or closet.
  • Wear proper gloves during the procedure.
  • The material of the introducer needle is not Magnetic Resonance Imaging (MRI)compatible. Do not insert introducer needle in MRI.
  • Do not bend the needle while using the product
  • Carefully evaluate and select the appropriate size catheter.
  • 18 to 24 gauge catheters are suitable for use with power injectors set to a maximum pressure of 300 psi.

INSTRUCTIONS FOR USE

  1. Open the package.

  2. Hold the safety cover, and remove the protector. Take care not to damage the needle tip.

  3. Check the condition of the introducer needle tip. Prior to patient insertion, separate the catheter from the introducer needle by twisting and reseating the catheter hub back into position with the advancing tab facing upward in alignment with the push button. Avoid touching the catheter or the metallic introducer needle while performing this separation. Separation of the catheter from the introducer needle will help ensure proper catheter advancement and needle retraction during venipuncture.
    [Notel Do not touch the catheter or the metallic introducer needle.

  4. Hold the SUPERCATH 5 on both sides of the finger grip, when access to the blood vessel is secured, push the catheter forward until it reaches the required depth.

  5. Release tourniquet (If used). Apply digital pressure to interrupt blood flow and hold catheter hub (to fix it at secure position).

  6. Before removing the introducer needle, apply pressure and press the white Activation button to retract the introducer needle into the safety cover.
    [Note] The built-in check valve together with the healthcare professional’s finger pressure, assists to reduce blood flashback when the introducer needle is withdrawn following blood vessel puncture. The built-in check valve is not intended to stop bleeding. Observe the catheter hub carefully when removing the introducer needle. If any sign of blood leakage is found, apply appropriate compression to achieve hemostasis.
    [Note] The check valve is intended for single use. Since it does not stop bleeding following removal of an infusion or transfusion set, apply pressure when disconnecting the male connector from the catheter hub.
    [Note] Firmly press the activation button to retract the needle into the safety cover.
    [Note] Bending the needle before or during use may affect proper needle retraction and proper check valve functionality.

  7. Promptly dispose of the SUPERCATH 5 into a sharps container immediately after use and follow facility protocol.

  8.  Securely connect the infusion or transfusion set to the catheter hub.
    [Note] Take care not to introduce air bubbles during connection.
    [Note] Before starting the infusion or transfusion, verify that the plunger has pierced the check valve and that suficient flow has been established.

  9. Secure the catheter and the infusion or transfusion tubing line with sterile gauze and tape or a transparent semi-permeable dressing. These dressings should be applied only to the catheter adapter and should not be placed directly on the catheter-skin junction site.

Explanation of symbols

MEDIKIT-SUPERCATH-5-Safety-Catheter-fig-5

Togo Medikit Co., Ltd.
17148-6, Aza Kamekawa, Oaza Hichiya,
Hyuga City, Miyazaki prefecture, Japan 883-0062

References

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