Description
PACKAGE CONTENTS
One Guidewire sterilized with Ethylene Oxide
CAUTIONS
• Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
• This device should be used only by physicians trained in angiography and percutaneous transluminal angioplasty (PTA).
• Read all instructions prior to use.
• Do not use if the package or sterile barrier is damaged or open.
• Use the guidewire prior to the “Use by” date on the package label.
• This a “Single Use Only” Guidewire – do not reuse or re-sterilize. Reprocessing may affect the functional integrity of the device. Incomplete sterilization may compromise malignant cross infection among patients.
• Refer to the instructions provided with other interventional devices to be used in conjunction with the Inno-Hydrowire for their intended use and contraindications.
DEVICE DESCRIPTION
The Inno-Hydrowire is intended to direct a catheter to the desired anatomical location in the vascular system during diagnostic or interventional procedures. It is provided sterile and is intended for single use only. It consists of a Nickel-Titanium alloy core wire; a polymer coating (Pebax containing BaSO4 for X-Ray visibility); and a hydrophilic coating applied to the entire wire. There are two shaft configurations: standard and stiff. There are two distal tip shapes: straight and angled. The Inno-Hydrowire includes a 3cm flexible tip. The Inno-Hydrowire is packaged in a plastic dispenser that is contained within an individual package. A Torquer is included which connects to the proximal end of the guidewire utilized for rotating and controlling the guidewire. The guidewires are packaged within a cardboard box which contains five individual guidewires.
INDICATIONS FOR USE
The Inno-Hydrowire Guidewire is intended to direct a catheter to the desired anatomical location in the vascular system during diagnostic or interventional procedures. This device is not intended for neurovasculature or coronary vasculature.
CONTRAINDICATIONS
The Inno-Hydrowire Guidewire is not intended for use in:
• The neurovasculature
• The coronary vasculature
• Patient judged not acceptable for percutaneous intervention
WARNINGS
• Do not manipulate or withdraw the guidewire through a metal needle or dilator.
• Do not advance or withdraw the device against resistance of unknown origin. Determine the cause by X-Ray and take necessary actions. Excessive force against resistance may result in vessel perforation /or damage.
• Do not attempt to use the guidewire if it has been bent, kinked or damaged.
• Do not put the guidewire into organic solvent, which may cause damage to the guidewire or its lubricity.
• Do not shape (reshape) the guidewire by any means. Reshaping the wire may cause damage and fracture.
• A torquer is included with guidewire, which is used to rotate and control the device. It cannot be inserted into the patient at any time.
• The guidewire is to be used by a physician who is thoroughly trained in the insertion, manipulation and observation of guidewires under fluoroscopy.
• The device should be disposed safely and properly, following local regulations and laws.
PRECAUTIONS
• Physicians should evaluate the suitability of the device or select appropriate specifications of the device according to the patient’s own condition and his/her own training skills and experience.
• The device must be moistened prior to removal from the dispenser in order to ensure lubricity. Heparinized physiological saline solution is recommended.
• Prior to reinsertion of the device during the same procedure, the wire should be rinsed in heparinized saline solution. Residual blood or other foreign matter can be removed by wiping the device with gauze that has been moistened with heparinized saline solution. Cleaning will not completely remove foreign substances, therefore the device is for SINGLE USE only.
DIRECTIONS FOR USE
1) Prepare the guidewire and any interfacing devices according to the manufacturer’s directions.
2) Using sterile aseptic technique, remove the guidewire and the loop together from the package in the sterile field.
3) Using a syringe, flush the loop with heparinized saline solution through the tube of the loop to increase surface lubricity.
4) Remove the guidewire from the loop and inspect the guidewire prior to use; verify that it is lubricated.
NOTE: If the guidewire cannot be easily removed from the loop, inject more heparinized saline solution into the loop.
5) Prior to use, inject the catheter with heparinized physiological saline solution to ensure the guidewire can move easily within the catheter.
6) Tighten the torque at the proximal end of the wire and make sure there is no movement between them.
7) Keep at least 5cm of the tip of the wire out of the loop during introduction. Gently push and reverse the guidewire under fluoroscopy.
8) Holding the guidewire in position, advance the catheter over the guidewire and into the target lesion.
9) Complete the procedure and remove the guidewire and catheter according to standard procedural protocol.
10) Dispose of the guidewire according to your facilities hazardous waste policy.
Product Performance
Made of Nikle-titaniumalloy wire, it has good torsion control and support.
Visible under X-ray equipment, can accurately judge the moving status of guide wire.
The surface is coated with hydrophilic coating, which has good stability and increases the lubricity of the guide wire.
The purpose is to establish a passageway fromthe puncture position to the lesion or to thedistal end through the lesion to assist otherinstruments in positioning.
Product Characteristics:
Type l
1,SS304V core with PTFE coating: providing improved smooth device delivery and guide wire trackability
2,Nitinol core design: for excellent durability and tip shape retention
3,TTungsten based polymer jacket with hydrophilic coating: enables enhanced visualization and steering ability
4,Dual core technology: for smooth transition between Nitinol core to NisS304V core
Type ll
1,Special designed dispenser to achieve easy flush
2,High quality 304 stainless steel with PTFE coating
3,Jtip radius : 3mm
Type lll
1,High quality Niti core wire enables 1:1 torque control for better navigation and faster vessel selection
2,TPU jacket with tungsten providing excellent visibility under x-ray
3,Unique coating technology ensure a lubricant surface durable
Ordering Information
