ARGON V-Stick Vascular Access Set Instruction Manual
- June 6, 2024
- ARGON
Table of Contents
ARGON V-Stick Vascular Access Set
**Instruction Manual**
https://www.argonmedical.com/resources/product-information
The symbols glossary is located electronically at www.argonmedical.com/symbols
V•Stick™ Vascular Access Set
Intended Use: V•Stick™ Vascular Access Sets facilitate fine needle venous or arterial puncture and tissue dilation for subsequent positioning of a 0.035″ or 0.038″ guidewire.
Device Description: The V•Stick™ Vascular Access Set consists of a 4F or 5F coaxial introducer set (with a 3F standard or 3F stiff dilator), a 21ga entry needle (with an echogenic or non-echogenic tip), and a 0.018” nitinol or stainless steel guidewire with a floppy radiopaque tip.
Indication for Use: The V•Stick™ Vascular Access Sets is intended for use in the introduction and placement of guidewires and/or catheters.
Contraindications: This device is contraindicated for use on patients who cannot receive antiplatelet and/or anticoagulant therapy. Physician judgment should be used in determining when percutaneous interventional procedures are contraindicated.
Complications/Risk:
- Bleeding
- Heamatoma
- Occlusion
- Infection
- Thrombosis
- Phlebitis
Warning/Precaution:
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The product must only be used by qualified personnel who are familiar withthe technique.
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This device was designed, tested and manufactured for single use only.
Reuse or reprocessing has not been evaluated and may lead to its failure and subsequent patient illness, infection or other injury. Do not reuse, reprocess or re-sterilize this device. -
Inspect the package integrity before use.
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Do not use if package is open or damaged and if the expiry date has been exceeded.
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Do not continue to use if any of the component are damaged during the procedure.
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The V•Stick™ Vascular Access Set is sterilized by ethylene oxide gas. Content is sterile and non-pyrogenic in unopened and undamaged package.
Do not use device if package has been damaged or has been opened.
Caution:
- The guidewire should not be withdrawn through the needle. Damage or shearing of the guidewire may occur.
- The 0.018” guidewire must be in appropriate position in the vessel before advancing the coaxial introducer system.
Direction for Use:
- Perform a skin incision under local anesthesia.
- Do a fine needle puncture of the vessel using the 21ga needle.
- Introduce the 0.018″ guidewire, making sure to loosen the straightener together with the guidewire on the circular dispenser.
- Remove the needle, place the fully assembled coaxial introducer system over the guidewire, and advance it to dilate the vessel.
- Loosen the inner dilator, making sure that the tip of the sheath introducer has been properly placed inside the vessel.
- Remove the inner dilator and the 0.018″ guidewire.
- Introduce a 0.035″ guidewire or a 0.038″ guidewire (not included in the set) through the sheath introducer.
- Remove the sheath introducer.
- Advance the required catheter over the guidewire.
Storage : Store at controlled room temperature.
Disposal : After use, this product may be a potential biohazard. Handle in a manner, which will prevent accidental puncture. Dispose in accordance with applicable laws and regulations.
NOTE : In the event a serious incident related to this device occurs, the event should be reported to Argon Medical at quality.regulatory@argonmedical.com as well as to the competent health authority where the user/patient resides.
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>