namic H965914051 Inflation Device Kit Instruction Manual

namic H965914051 Inflation Device Kit

Inflation Device Kit

Rx Only – Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Carefully read all instructions prior to use. Observe all warnings and precautions noted throughout these instructions. Failure to do so may result in serious complications.

WARNING
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Medline Industries, LP representative. Inspect prior to use to verify that no damage has occurred during shipping.
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
After use, dispose of the product and packaging in accordance with hospital, administrative, and/or local government policy or death of the patient.

DEVICE DESCRIPTION

The Namic Inflation Device kits are intended for general intravascular procedures and it is made up of different configurations of devices needed to perform the procedure, including
Y-Adaptors, Guidewire Introducer, Torque Devices, and/or Pressure Monitoring Lines. Depending on the kit selected, one or more of the following devices may be included. The individual devices also may be sold separately.

• The Name Inflation Syringe is a 20mL disposable device capable of producing a maximum pressure of 30 ATM/bars, fitted with a threaded plunger assembly with lock/release bar, a flexible high-pressure extension tube, and a three-way medium pressure stopcock. The Medline Inflation Syringe is designed to generate positive and negative pressure, and monitor positive pressures over a range of zero to +30ATM/bar (zero to +441 psi).
• The Y-Adaptor consists of one or two adjustable hemostatic valve(s) to provide a fluid-tight seal around interventional catheters and guidewires, a lumen with a female Luer for pressure monitoring, and/or manual infusion, and a rotating adaptor on the distal end of the device.
• The Name Stopcock is a multi-lumen device, which is intended to control the flow of water-based solutions or radiographic contrast media by manipulation of the handle.
• The Namic Pressure Monitoring Lines are intended for use in Fluid Management and/or Invasive Pressure monitoring applications.
• The Guidewire Introducer contains a polycarbonate hub and stainless steel cannula. The Torque Device is composed of a plastic shell and an internal metal ball.

INTENDED USE / INDICATIONS FOR USE

The Namic Inflation Device kit is recommended for use while performing interventional procedures.

• The Namic inflation device is used to inflate and deflate an angioplasty balloon or another interventional device, and to measure the pressure within the balloon.
• Y-Adaptors are recommended for supporting a fluid-tight seal around percutaneous transluminal catheters and guidewires.
• Namic stopcocks are intended for use in hemodynamic monitoring procedures and for intra-arterial and intravenous administration of water-based solutions or radiographic contrast media.
• The Namic Pressure Monitoring Lines are intended to be used in Fluid Management and/or Invasive Pressure monitoring systems.
• The Guidewire Introducer is used as an optional device inserted into the Y-Adaptor to provide a smooth introduction of the guidewire into the Y-Adaptor.
• The Torque Device is used to securely attach to the distal portion of the guidewire to provide a larger rigid surface for the physician to turn and steer the guidewire during insertion into the blood vessel.

CONTRAINDICATIONS

General

• Ensure that you are making secure connections when using this device to prevent the introduction of air into the system that could result in embolism and in rare instances death.
• All connections should be finger tightened. Over tightening can cause cracks and leaks to occur that could result in embolism and / or exposure to biohazards.
• Examine product carefully for entrapped air and fully de-bubble prior to injection to minimize the potential for embolism and in rare instances death.
• Do not use if package is opened or damaged.
• Carefully read all instructions prior to use. Observe all warnings and precautions noted throughout these instructions. Failure to do so may result in serious complications.

Y-Adaptor

• Excessive aspiration rate through the angled side port may result in air bypass through the hemostatic valve(s).

Namic Stopcock

• Namic Stopcocks are not recommended for use with lipids. Prolonged exposure to lipid solutions may result in stress cracking or leakage.

Torque Device

• This device should be used only by physicians thoroughly trained in angiography procedures.

Inflation Device

The device is not intended to be used for dispensing fluids into the body.

Pressure Monitoring Lines

• Notification of the presence of phthalates is indicated on package label. The
• Namic Pressure Monitoring Lines are manufactured using polyvinyl chloride PHT (PVC) which contains one or more phthalates, including di (2-Ethylhexyl)
• phthalate (DEHP), which is used to soften the polymer and make it suitable for
• use in this application. Small quantities of DEHP may leach out into the patient DEHP during clinical use. Animal studies have shown that high-level exposure to
• DEHP affects male fertility and reproductive development in rats. Although there is currently no scientific consensus that suggests that the same effect occurs in humans, care should be taken to minimize exposure of this device to children and pregnant or nursing women.

PRECAUTIONS

• Before use, inspect the device to verify that no damage has occurred during shipping and handling.
• Do not overtighten the Y-Adaptor hemostatic valve(s). This may cause the lumen of the catheter to collapse and/or impair free movement of the wire.
• Always be sure that the hemostatic valve(s) is completely closed during aspiration or injection.
• The user of this device should carefully consider the size of the device(s) to be inserted through the hemostatic valve when selecting the appropriate Y-Adaptor.
• Pressures greater than those listed in the Offering Chart may result in leakage or detachment of Y-Adaptor components.
• Inspect the syringe and tubing (and stopcock, if applicable) to ensure that the device has been completely purged of air bubbles.
• This device should be used only by physicians thoroughly trained in angioplasty procedures.

POTENTIAL COMPLICATIONS

Potential complications associated with percutaneous transluminal catheters, guidewires, stopcocks and fluid management include but are not limited to:

• Allergic reaction (including anaphylaxis) Arterial/venous thrombosis
• Cardiac or respiratory arrest
• Cerebral vascular accident
• Death
• Embolism (including air embolism)
• Exposure to biohazards Hemorrhage
• Infection
• Myocardial infarction Transient ischemic attack (TIA)

HOW SUPPLIED

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if the sterile barrier is damaged. If damage is found, call your Medline Industries, LP representative. Inspect prior to use to verify that no damage has occurred during shipping.
After use, dispose of the product and packaging in accordance with hospital, administrative, and/or local government policy.

DIRECTIONS FOR USE

Namic Inflation Device and Stopcock Priming:

1.  To prep the Namic Inflation syringe, simply aspirate up to 20mL of solution into the inflation syringe by pressing on the lock/release mechanism and pulling back on the handle. CAUTION: Inspect the syringe tubing and stopcock (if used) to insure that there is no air in the system.
2.  Press the lock/release mechanism and push the handle forward to remove air in the device. CAUTION: If applied pressure does not indicate on gauge, discontinue use immediately and replace it with a new unit.

ATTACHING THE INFLATION DEVICE TO THE BALLOON
NOTE: Refer to the manufacturer’s directions accompanying the balloon dilatation catheter or another interventional device for specific information on use, maximum inflation pressure, precautions, and warnings for that device.

1.  Prepare and test the balloon catheter according to the catheter manufacturer’s directions for use.
2.  Create a fluid-fluid connection between the balloon and the inflation device extension tube and connect the luer connectors securely.
3.  Press the lock/release mechanism and pull back on the handle to apply a vacuum to the balloon.

BALLOON INFLATION AND DEFLATION

1.  To inflate the balloon, squeeze the trigger allowing the plunger to return to the resting position (0 ATM/BAR). Release grip on the trigger, locking the plunger into position. To increase pressure, rotate the handle clockwise until the desired inflation pressure is reached. The lock mechanism maintains the pressure.
   NOTE : Loss of pressure may indicate a leak in the system. To protect the threads of the lock release handle, the device must be displaying 25 ATM or lower before quick-release mechanism is used to deflate the angioplasty balloon.

2.  To deflate the balloon, squeeze the trigger and pull back to generate negative pressure. Disengage the lock/release mechanism to lock the plunger in the negative pressure position.
   WARNING: If applied pressure does not indicate on gauge, discontinue use immediately and replace it with a new unit.

Y-Adaptor, Guidewire Introducer, and Torque Device

1.  Open the hemostatic valve(s) on the Y-Adaptor (counter-clockwise direction) to its maximum size.

2.  Attach the contrast injection line, pressure monitoring line, or other fluid management device to the female luer on the side-port of the Y-Adaptor. Fully flush all devices with saline media to de- bubble and remove any trapped air.
   WARNING : Examine product carefully for entrapped air and fully de-bubble prior to injection to minimize the potential for embolism and in rare instances death.

3.  Close the hemostatic valve(s) on the Y-Adaptor (clockwise direction) and connect the rotating male luer adaptor to the proximal end of the guide catheter. Aspirate any air that may have entered the system during the connection.

4.  Open the valve(s), and allow for any bleed-back and/or flush out the hemostatic valve(s), once connected to the guide catheter and prior to insertion of any device(s).

5.  Insert the interventional device or guidewire through the hemostatic valve. If desired, insert the guidewire introducer through the opened valve(s) and feed through the wire through the introducer. Holding the wire firmly in place, remove the guidewire introducer, once wire is in the desired location.

6.  Advance device(s) to desired location and close (clock-wise direction) the hemostatic valve(s) over the interventional device(s).

7.  Ensure the hemostatic valve(s) is in the closed position when not exchanging devices to minimize patient blood loss.

Re-examine fluid path to ensure the system is free of air.

Refer to the interventional device manufacturer’s recommendations for proper use to perform the procedure. If utilizing a balloon, ensure the balloon is completely deflated prior to insertion or removal through the Y-Adaptor.
Once the procedure is complete or Y-Adaptor is no longer required, disconnect from the guide catheter.

Y-Adaptor Chart

Adaptateur en Y| Pression nominale en lb/po2| DI de la lumière principale| DI de la lumière latérale
---|---|---|---
Namic Option 125| 1 379 kPa

(200 lb/po2)

| 3,18 mm/9,5 F

(0,125 po)

| S.O.
Namic gros calibre| 1 379 kPa

(200 lb/po2)

| 2,87 mm/8,6 F

(0,113 po)

| S.O.
Adaptateur en Y Namic| 1 379 kPa

(200 lb/po2)

| 2,54 mm/7,6 F

(0,100 po)

| S.O.
Adaptateur en Y Gateway Plus| 4 137 kPa

(600 lb/po2)

| 3 mm/9 F

(0,118 po)

| 2,413 mm/7,2 F

(0,095 po)

WARRANTY

Medline Industries, LP warrants that reasonable care has been used in the design and manufacture of this instrument. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether express or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness for a particular purpose. Handling, storage, cleaning, and sterilization of this instrument as well as other factors relating to the patient, diagnosis, treatment, surgical procedures and other matters beyond Medline Industries, LP’s control directly affect the instrument and the results obtained from its use. Medline Industries, LP’s obligation under this warranty is limited to the repair or replacement of this instrument, and Medline Industries, LP shall not be liable for any incidental or consequential loss, damage, or expense directly or indirectly arising from the use of this instrument. Medline Industries, LP neither assumes nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this instrument. Medline Industries, LP assumes no liability with respect to instruments reused, reprocessed, or resterilized and makes no warranties, express or implied, including but not limited to merchantability or fitness for a particular purpose, with respect to such instruments. GateWay Plus™ are trademarks and/or registered trademarks of Boston Scientific, LP

Read User Manual Online (PDF format)

Read User Manual Online (PDF format)  >>

Download This Manual (PDF format)

Download this manual  >>