Merit Medical H2O Hydrophilic Guide Wire - Manual

2. After hydrating the guide wire, gently grasp the J-straightener device and pull from
the dispenser. Once the straightener is separated from the dispenser, continue to remove
the wire from the hoop.
3. If guide wire is not properly hydrated, it will be difficult to remove from the dis-
penser. Inject additional heparinized saline solution into dispenser and repeat step # 2.
Instructions for use:
1. Fill intended device with heparinized saline solution before and during use to ensure
smooth movement of the hydrophilic guide wire within the device.
2. Use of sterilized gauze moistened with heparinized saline solution and/or a torque
device will facilitate handling of the wire.
3. Insert the guide wire into the device and advance to the desired position.
WARNING: IF MOVEMENT OF THE WIRE WITHIN THE DEVICE BECOMES DIMINISHED,
REMOVE GUIDE WIRE AND REACTIVATE THE HYDROPHILIC COATING BY WETTING ITS
ENTIRE SURFACE WITH A HEPARINIZED SALINE SOLUTION.
4. Wipe the guide wire with 4x4 gauze moistened with heparinized saline solution to
remove excess blood from the guide wire surface.
WARNING: DO NOT USE DRY GAUZE AS THIS MAY DAMAGE THE GUIDE WIRE SUR-
FACE RESULTING IN INCREASED RESISTANCE WHEN THE WIRE IS REINSERTED INTO
THE DEVICE.
5. Rehydrate the guide wire prior to re-insertion into any device or placement into a
patient.
6. Use of alcohol, antiseptic solutions or other solvents must be avoided.
WARNING: THESE SOLUTIONS MAY ADVERSELY AFFECT THE SURFACE OF THE
HYDROPHILIC GUIDE WIRE.
7. After cleaning the wire, place into the saline filled hoop, proximal end first. The wire
may also be placed in a guide wire basin and completely covered with heparinized saline
solution.
Note: Merit Medical does not recommend a particular technique for the use of this
guide wire. The steps contained in the proceeding instructions are for informational pur-
poses only. Each physician should evaluate their appropriateness according to individual
patient condition and his or her medical training and experience.
Troubleshooting:
If the guide wire does not move with ease upon re-insertion, withdraw and completely
rehydrate the wire. If upon re-insertion, the wire does not move with ease, exchange for
a new hydrophilic guide wire.
Package Contents:
Merit Medical Hydrophilic Guide Wire: Guide wire length, diameter, coating, tip, and core
configurations are indicated on the product label. Merit Medical guide wires are pack-
aged in a plastic hoop fitted with a luer hub. This packaging is provided to facilitate com-
pliance with the manufacturer recommended guidelines that the wire must be flushed
with saline or heparinized saline prior to use (See instructions for use).
Storage:
Guide wires should be stored in a cool, dry place.
Merit Medical Systems, Inc. South Jordan, Utah 84095
U.S.A. 1-801-253-1600 U.S.A. Customer Service 1-800-356-3748
Merit Medical Ireland Ltd,
Parkmore Business Park West, Galway, Ireland
www.merit.com 401813002/A ID 030104
I N S T R U C T I O N S F O R U S E
Description:
Merit Medical hydrophilic guide wires are constructed from a high quality, steerable,
metallic core wire with a polymer coating utilizing a sophisticated construction process.
A hydrophilic coating is applied over the radiopaque polymer jacket. Guide wires are
supplied sterile, non-pyrogenic and are intended for single use only.
Indications for use:
Guide wires are used to facilitate the subsequent introduction(s) of intravascular devices
during diagnostic and interventional Cardiology and Radiology angiographic procedures.
Hydrophilic guide wires may also be utilized in other diagnostic and therapeutic
Radiology procedures.
Warnings/Adverse Reactions:
Carefully read all instructions prior to use. Observe all warnings and cautions. Failure to
do so may result in complications. Vessel trauma may result from the improper use of
this device.
Care should be taken when manipulating a guide wire inside a vessel during device place-
ment and removal. Guide wires should be manipulated only under fluoroscopy. If resist-
ance occurs and the cause of resistance cannot be determined, remove the guide wire
and device as a unit. Never advance the guide wire against resistance without first deter-
mining the reason for the resistance under fluoroscopy. Excessive force against resist-
ance may result in damage to the wire and/or to the vessel.
Other potential adverse reactions which may result from the improper use of a guide wire
include, but are not limited to:
Thrombus Emboli
Arterial or venous vessel wall damage Plaque dislodgment
Hematoma at the puncture site Infection
Vessel perforation Vessel spasm
Hemorrhage Vascular thrombosis
The physician should be familiar with the literature concerning the complications of
angiography.
Cautions:
AT LEAST 5 CM OF THE WIRE SHOULD PROTRUDE FROM THE DEVICE HUB AT ALL
TIMES TO PREVENT THE WIRE FROM SLIDING ENTIRELY INTO THE DEVICE DUE TO
THE LOW SLIDING FRICTION OF THIS WIRE.
AVOID MANIPULATING OR WITHDRAWING THE HYDROPHILIC GUIDE WIRE BACK
THROUGH A METAL NEEDLE OR CANNULA. A SHARP EDGE MAY SCRAPE THE COAT-
ING OR SHEAR THE GUIDE WIRE. A CATHETER, INTRODUCER SHEATH OR VESSEL
DILATOR SHOULD REPLACE THE NEEDLE AS SOON AS THE GUIDE WIRE HAS BEEN
INSERTED INTO THE VESSEL.
For single use only do not reuse, reprocess or resterilize. Inspect wire for damage prior
to use, do not use any unit if package is opened or damaged. This device is sterilized by
ethylene oxide gas. It is recommended that a plastic torque device be used to handle the
hydrophilic guide wire. Use of a metal torque device may damage the guide wire surface
coating. Federal law (USA) restricts this device to the sale and use only by or on the
order of a physician.
Preparation for use:
1. Before attempting to remove the guide wire from its' dispenser, inject sterile
heparinized saline solution into the luer lock hub end of the dispenser to fill the dispenser
coil. This will completely cover the guide wire surface, activate the hydrophilic coating,
and will make the guide wire very lubricious.
WARNING: FAILURE TO HYDRATE DISPENSER HOOP PRIOR TO GUIDE WIRE
REMOVAL MAY RESULT IN GUIDE WIRE DAMAGE AND OR DIFFICULT REMOVAL FROM
THE DISPENSER.