Directions For Use; Indications For Use - BIOTRONIK Cruiser-18 Manual Del Usuario

CRUISER-18 GUIDE WIRES
USA CAUTION
Federal (USA) law restricts this device to sale by or on the order of
a physician.
CAUTION
This device should be used only by physicians trained in angiography
and peripheral endovascular intervention.
Do not use if package is damaged
Do not re-sterilise or re-use
Do not wipe with alcohol
See Instructions for Use
Sterilised with ethylene oxide gas
Use the guide wire prior to the "Use by date" on the package label,
preceded by the symbol
Refer to the instructions supplied with any interventional devices
to be used in conjunction with the Cruiser-18 guide wire for their
intended uses, contraindications, and potential complications.
DESCRIPTION
The Cruiser-18 guide wire is a steerable guide wire with a shapeable
distal tip.
CONTENTS. 1 guide wire
STORAGE. Store in a cool, dark, dry place

INDICATIONS FOR USE

The Cruiser-18 guide wires are intended for use in the peripheral
vasculature.
CONTRAINDICATIONS
The Cruiser-18 guide wire is not intended for use in the coronary
or cerebral vasculature.
Patients judged not acceptable for percutaneous intervention (PCI)
WARNING
A guide wire is a delicate instrument and must not be advanced,
withdrawn, or torqued if resistance is met. Guide wire
manipulations must always be observed under fluoroscopy.
If the guide wire is removed and is to be re-inserted, it must be
inspected for signs of damage (weakened or kinked segments)
prior to re-introduction.
Do not re-introduce if guide wire is weakened or kinked.
Reuse of single-use devices creates a potential risk of patient or
user infections. Contamination of the device may lead to injury,
illness or death of the patient.
Cleaning, disinfection and sterilization may compromise essential
material and design characteristics leading to device failure.
PRECAUTIONS
performance and result in complications.
diameter with that specified on the adjunct devices.
Identify the flexing plane before shaping. Shape in the same
plane as that for flexure.
be carried out when monitored by high quality fluoroscopy.
metal cannula or sharp-edged object.

DIRECTIONS FOR USE

1. Using a sterile, aseptic technique remove the guide wire and the
protection spiral from the package and place onto a sterile field.
2. To enhance the gliding performances of the guide wire, flush the
protection spiral with saline. A Luer lock connection is attached
to the protection spiral.
3. Push gently the proximal end of the guide wire starting from the
window of the protection spiral, so that the tip and a portion of
the shaft is being exposed out of the Luer lock. Push until the
entire proximal end has disappeared into the protection spiral.
Pull gently at the distal guide wire shaft, which is then protruding
out of the Luer lock until the entire wire is removed out of the
protection spiral. Do not grasp the distal tip of the guide wire
while removing it from the protection spiral.
4. If desired, shape the guide wire tip using standard technique.
When preparing to shape the tip section, hold the tip between the
two fingers. Gently "brush" the spring coil to identify the plane
of flexure and complete the shaping procedure. Inspect the coils
for damage after the shaping operation. Do not use a shaping
instrument with a sharp edge.
5. Insert the guide wire into the introducer sheath and advance it
into the target vessel and across the lesion using fluoroscopy to
facilitate proper guide wire placement.
6. Introduce the catheter system over the proximal end of the guide
wire and through the haemostatic valve of the introducer sheath
and advance it into the target lesion.
7. A torque application device may be applied to the proximal end of
the guide wire.
8. Note: The guide wire should be positioned in the centre of the
torque application device. The torque application device should
be tightened fully.
9. Complete the procedure and remove the adjunct device and guide
wire according to procedural protocol.
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