Indications For Use - Medtronic InTRAkit Instrucciones De Uso

2016/JUN/06 at 11:44 a.m. Doc number: M057366T001 Rev. 1C [global]
Printspec i - 4.0 x 11.0 inches
InTRAkit™
Access Kit
1. Device Description
1
2
3
Figure 1. Access Kit Components
The access kit consists of
■ a micropuncture needle (3) or an IV catheter (2) (an IV catheter includes a
needle and a plastic IV cannula)
■
a mini-guidewire (5) (some access kits have a plastic-jacketed mini-guidewire)
■ a vessel dilator (1)
■
an introducer sheath (4) that is color-coded to indicate the size of the largest
intravascular device that will pass through the introducer sheath (Table 1), and
that features a suture groove (6)
Table 1. Color-Coding on introducer sheath
French
4
5
6

2. Indications for Use

The introducer sheath is used to facilitate placing a catheter through the skin and
into a vein or artery, including, but not limited to, the radial artery. The
micropuncture needle or IV catheter is used to gain access to a vein or artery,
including, but not limited to, the radial artery, for placement of the mini-guidewire.
The mini-guidewire is used for placement of the sheath into a vein or artery,
including, but not limited to, the radial artery.
3. Contraindications
None known.
4. Warnings
Caution: Read all instructions carefully. Failure to properly follow the instructions,
warnings, and precautions may lead to serious consequences or injury to the
patient.
■ For single-patient use only. Do not reuse, reprocess, or resterilize this product.
Reuse, reprocessing, or resterilization may compromise the structural integrity
of the device and/or create a new risk of contamination of the device, which
could result in patient injury, illness, or death. Cleaning, disinfection, and
resterilization may compromise essential material and design characteristics of
the device and lead to device failure.
■
Avoid use of alcohol, antiseptic solutions, and other solvents as they may
adversely affect the surface of the introducer sheath.
■ Administer anticoagulation therapy to reduce potential thrombosis. If the patient
is not anticoagulated, thrombus formation may occur.
■ Do not use excessive force when manipulating the introducer sheath, as this
could cause product or vessel damage.
■
Do not inject drugs that include oil components such as lipid emulsions, castor
oil, interfacial active agents, or solubilization agents such as alcohol, through
the stopcock as these solvents may adversely affect the product.
■ When a catheter or vessel dilator is present inside the introducer sheath, do not
flush the stopcock.
5. Precautions
■ Prior to a radial access procedure, verify that there is adequate collateral flow
to the hand through the ulnar artery. Consider an alternate access site if there
is insufficient flow.
■ This kit is intended for use by trained personnel.
■
Use kit immediately after opening package.
■ Use kit prior to the Use-by Date.
■
Store in a cool, dark, dry place.
■ Prior to use, confirm that introducer sheath size is appropriate for the access
vessel and system to be used with this kit.
■ Do not use a metal cannula or micropuncture needle with a plastic-jacketed
guidewire.
■
Do not attempt to reinsert a partially or completely withdrawn needle into the
plastic IV cannula.
■ Do not aspirate from the stopcock with the guidewire in place through the
hemostasis valve.
■ Do not use a power injector for contrast media injection through the stopcock.
■
Do not reshape the mini-guidewire.
master:20160505, alldocMod:20160504, alldocMod2:20151009, alldocStyle_graph:20160504,
alldocStyle:20160504, master_pageset:20160504, languageLookup:20160330, table:20160113,
characterJoin:20110211, 3of9:20110211, 3of9_svg:20110211
4
5
6
Color
Red
Gray
Green
Instructions for Use English 3