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Merit Medical SeaDragon Torque Device User Manual

Merit Medical Health and hygiene

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Product descriPtion:

A guide wire torque device designed with a cylindrical shape and a white cap grip mechanism that,

when depressed, opens the lumen to allow passage of a guide wire. When the cap is released, the

guide wire is gripped tightly to allow easy manipulation.

intended use:

The Merit torque device is recommended to facilitate guide wire manipulation

during interventional procedures.

contraindications:

There are no known contraindications for these devices.

cautions:

• Read instructions prior to use.

Px only - caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

• Store in a cool dry place.

• This device is intended for single use only . Do not reuse or resterilize.

• Prior to use, the device should be examined to verify functionality and ensure that its size

and shape are suitable for the specific guide wire to be used.

reuse Precaution stateMent

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.

Potential coMPlications:

Refer to the guide wire labeling for potential complications associated with the use of their device.

instructions for use:

1. Squeeze white cap of the device toward the body to align lumens.

2. Once lumens are aligned, insert proximal tip of guide wire through device.

3. Continue squeezing white cap and slide device along guide wire until desired location is reached.

4. Release squeeze to activate locking mechanism.

5. Grasp and rotate device using ridges on back of the device to steer guide wire tip

to desired position.

6. To move torque device to a new position, squeeze white cap and slide device along

the guide wire to desired position, then release.

7. To remove torque device from guide wire, squeeze white cap and slide device off guide wire.

Manufacturer: Merit Medical Systems, Inc. South Jordan, Utah 84095 www.merit.com

U.S.A. 1-801-253-1600 U.S.A. Customer Service 1-800-356-3748

Authorized Representative: Merit Medical Ireland Ltd, Parkmore Business Park West, Galway, Ireland

ID 030711 400880004/A

TORQUE DEVICE

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