Merit Medical ClassicSheath Splittable Hemostatic Introducer System - Manual (Page 3)

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English ∙ LAB
-333-00
Single Use Only /
Do Not Reuse
Sterilized Using
Ethylene Oxide
Caution, read intructions
prior to use
Contents (Numeral repre-
sents quantity of units inside)
Do Not Resterilize
Do not use if package is
opened or damaged
Store in a cool, dark and
dry place
Size
Length
Non-pyrogenic
Graphic Symbols for Medical Device Labeling
This device is intended for one time use only.
Read instructions prior to use.
CAUTION: Federal (U.S.A.) Law restricts this
device to sale by or on the order of a physician.
Indications
For the introduction of various types of pacing or
defribrillator leads and catheters.
Warnings
Improper use of the TVI can cause air embolism and
back bleeding.
Precautions
• Do not alter this device in any way.
• Single Use Devices: This single-use product
is not designed or validated to be reused.
Reuse may cause a risk of cross-contamination,
affect the measurement accuracy, system
performance, or cause a malfunction as a result
of the product being physically damaged due to
cleaning, disinfection, re-sterilization, or reuse.
• When using the TVI tool, lead size may not
exceed the size of the TVI tool.
• When using the TVI, always keep the exposed
proximal end covered to prevent air embolism
and back bleeding.
• When retaining a guidewire, the TVI tool must
be placed over the guidewire and not along the
side of it.
Use Sterile Technique A suggested procedure:
1. A TVI is to be used at the physician’s discretion
to open the sheath valve for ease of lead
placement.
2. CAUTION! When the TVI is inserted into the
ClassicSheath valve housing, all hemostasis is
lost and the risk of air embolization and back
bleeding exists. Always keep the proximal
exposed end of the TVI covered with your thumb
while the TVI is in use.
3. To use the TVI, insert the distal end of the TVI into
the valve housing by gently pushing the TVI into
the sheath.
4. Hold your thumb over the proximal exposed
opening of the TVI to prevent air embolism or
back bleeding.
5. Advance the pacing lead or catheter through the
TVI and into the sheath.
6. As soon as the pacing lead or catheter is resting
inside the sheath, pull the TVI back out of the
sheath valve housing.
7. The TVI may then either be peeled away or it may
be temporarily left resting on the shaft of the pac-
ing lead or catheter.
8. Once the TVI has been withdrawn from the
sheath, aspirate the sheath through the sideport,
until any air which may have entered the sheath
during the procedure is removed. Flush with
Heparinized saline.
The Transvalvular Insertion Tool (TVI) is an op-
tional device for use with the
TVI Instructions for Use
Classic
sheath
systems