Merit Medical Tenor Steerable Guidewire IFU User Manual

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proximal end of the guidewire.

In order to aid in the selective placement of the
catheter into a particular vessel, gently rotate the
proximal end of the guidewire as it
is advanced forward.

Use accepted angiographic techniques to steer
the guidewire to the intended location.

Warning: Always maintain visualization of the

guidewire under fluoroscopy, ensuring that the tip is

moving freely when torque is applied.

When the desired guidewire position is achieved,
secure the guidewire in place
while tracking the catheter over it and to the
treatment location.

Once the micro-catheter is in position, gently
remove the guidewire prior to any intervention.

CAUTION:

PX Only:

Federal (USA) law restricts this device to use by

or on the order of a licensed physician.

CONTRAINDICATIONS:
There are no known contraindications for the use of
steerable guidewires.

STORAGE:
Store the Tenor Steerable Guidewire in a cool, dark, dry
area.

COMPATIBILITY:
The Tenor Steerable Guidewire is compatible with
catheters which use 0.014” or 0.018” guidewires in
intravascular procedures.

BioSphere Medical assumes no liability with
respect to instruments reused, reprocessed
or re-sterilized, and makes no warranties,
expressed or implied, including, but not limited
to, merchantability or fitness for intended use
with respect to such instrument.

Information on packaging:

Symbol Designation

Manufacturer: Name & Address

Use by date: year-month

Batch code

Catalogue number

Do not resterilize

Do not use if package is damaged

Keep away from sunlight

Keep dry

Do not re-use

Caution -

Refer to Instructions For Use

Sterilized using ethylene oxide

EC mark logo -

Notified body identification : 0459

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