Merit Medical Tenor Steerable Guidewire IFU: instruction

Biosphere Medical, S.A.

Parc des Nations - Paris Nord 2

383 rue de la Belle Etoile

95700 Roissy en France

France

Manufactured for:

Merit Medical Systems, Inc.

1600 West Merit Parkway, South Jordan,

Utah 84095 U.S.A. 1-801-253-1600

U.S.A. Customer Service 1-800-356-3748

www.merit.com

730131002/A ID 081213

Instructions for use ............................ English ..................................................... 2

Instructions d’utilisation .................. Français (French) ..................................... 4

Инструкции за употреба .................Български (Bulgarian) ........................... 6

Pokyny pro použití ............................Čeština (Czech) ........................................ 8

Brugsanvisning ..................................Dansk (Danish) ......................................10

Gebruiksaanwijzing ..........................Nederlands (Dutch) ...............................12

Kasutusjuhised ..................................Eesti (Estonian) ...................................... 14

Käyttöohjeet ...................................... Suomi (Finnish) .....................................16

Gebrauchsanweisungen ...................Deutsch (German) ................................. 18

Οδηγίες χρήσης .................................Ελληνικά (Greek) ................................... 20

Használati útmutató ..........................Magyar (Hungarian) ..............................22

Istruzioni per l’uso .............................Italiano (Italian) .....................................24

Lietošanas norādījumi ......................Latviešu (Latvian) ..................................26

Naudojimo instrukcijos .....................Lietuviškai (Lithuanian) ........................28

Instruksjoner for bruk ....................... Norsk (Norwegian) ................................30

Instrukcja stosowania ....................... Polski (Polish) ........................................ 32

Instruções de utilização ....................Português (Portuguese) .......................34

Instrucţiuni de utilizare ..................... Română (Romanian) .............................36

Инструкции по применению ..........Русский (Russian) .................................38

Návod na použitie .............................Slovenčina (Slovak) ...............................40

Instrucciones de utilización .............. Español (Spanish) .................................. 42

Bruksanvisning .................................. Svenska (Swedish).................................44

Kullanma talimatları ..........................Türkçe (Turkish) .....................................46

0459 - 2011

guidewire tip, damage to the catheter, or

vessel perforation.

• The hydrophilic coating has an extremely

English

lubricious surface only when properly

hydrated.

DESCRIPTION

This Tenor Steerable Guidewire (0.014” or 0.018”)

is a stainless steel guidewire with a polymer distal

PRECAUTIONS

tip and a 3 cm radiopaque distal tip that is

• Do not expose guidewires to extreme

shapeable for 1 cm. The distal 50 cm is coated

temperatures or solvents.

with a hydrophilic coating. The guidewire length

• Prior to use, carefully examine the guidewire and

is depicted on the product label.

packaging to verify proper function and integrity.

• Extreme care should be taken when shaping the

INDICATIONS FOR USE

guidewire distal tip. Over-manipulation of the

The Tenor Steerable Guidewire is intended to

guidewire distal tip may cause damage. Damaged

facilitate the placement of catheters within the periph-

guidewires should not be used.

eral vasculature for various diagnostic and interven-

tional procedures.

COMPLICATIONS

Procedures requiring percutaneous catheter introduc-

WARNING

tion should not be attempted by physicians unfamiliar

• Contents supplied sterile.

with the possible complications listed below. Possible

complications may include, but are not limited to, the

• Do not use if pouch is opened or damaged. Verify

following:

that the package integrity has been maintained

to ensure the sterility of the device.

• Hemorrhage

• Do not use in case of any surface irregularities,

• Infection

bends, or kinks. Any damage of the guidewire

• Ischemia

may change its characteristics likely to aect its

• Perforation of vessel or arterial wall

performance

• Puncture site hematoma

• Use the device prior to the “Use Before” date

noted on the package.

• Thrombus formation

• For single patient use only.

• Vasospasm

Do not reuse, reprocess, or resterilize.

• Vessel wall dissection

Reusing , reprocessing or resterilizing may

compromise the structural integrity of the device

and or lead to device failure, which in turn may

PREPARATION FOR USE

result in patient injury, illness, or death. Reusing,

• Open carefully the pouch and remove the hoop

reprocessing or resterilizing may also create a

from the pouch

risk of contamination of the device and or cause

• Flush the hoop with heparinized saline prior to

patient infection or cross infection including,

guidewire removal.

but not limited to, the transmission of infectious

disease(s) from one patient to another. Contami-

• Remove the guidewire from the hoop.

nation of the device may lead to injury, illness or

• If the guidewire is to remain unused at

death of the patient.

any time during the procedure, be sure to rehy-

• Discard the product after use.

drate with heparinized saline prior

to reinsertion.

• This device should be used only by

physicians thoroughly trained in percutaneous,

intravascular techniques and procedures in

INSTRUCTIONS FOR USE

relevant areas of the anatomy.

• The distal tip of the guidewire can be carefully

• Do not attempt to move the guidewire

shaped to the desired tip conguration, using

without observing the guidewire tip. Always

standard practices.

maintain visualization of the guidewire under

• Insert the steerable guidewire, exible end rst,

uoroscopy.

into the catheter lumen using a guidewire inser-

• Do not push, pull, or rotate the wire against resis-

tion tool. Test the guidewire for free movement

tance. If resistance is met, discontinue movement

within the catheter. Then, advance the catheter

of the guidewire, determine the

into the guide catheter. During this step, exercise

reason for resistance, and take appropriate action

caution not to allow the guidewire to protrude

before continuing. Movement of the catheter or

beyond the catheter tip, this may damage it.

guidewire against resistance may result in separa-

• To aid in rotating or steering the guidewire,

tion of the catheter or

secure the supplied torque device to the

2

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 uoroscopy, 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:

P

Only: Federal (USA) law restricts this device to use by

X

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.

Information on packaging:

COMPATIBILITY:

Symbol Designation

The Tenor Steerable Guidewire is compatible with

catheters which use 0.014” or 0.018” guidewires in

Manufacturer: Name & Address

intravascular procedures.

Use by date: year-month

BioSphere Medical assumes no liability with

respect to instruments reused, reprocessed

Batch code

or re-sterilized, and makes no warranties,

expressed or implied, including, but not limited

Catalogue number

to, merchantability or tness for intended use

with respect to such instrument.

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 -

Notied body identication : 0459

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