Spectranetics Quick-Cross Select 518-085 Mode D'emploi page 3

1. DESCRIPTION
2. INDICATIONS FOR USE
3. CONTRAINDICATIONS
4. WARNINGS
5. PRECAUTIONS
6. ADVERSE EFFECTS
7. HOW SUPPLIED
8. COMPATIBILITY
9. PROCEDURE SET-UP AND DIRECTIONS FOR USE
10. MANUFACTURER'S LIMITED WARRANTY
11. NON-STANDARD SYMBOLS
1. DESCRIPTION
The Spectranetics Quick-Cross Select Support Catheters are intravascular catheters. These catheters are available in a variety of lengths and tip configurations. All models have
3 radiopaque markers spaced equally along the distal shaft to aid in estimating geometry within the vascular system. The distal radiopaque marker is positioned within 3 mm of
the distal catheter tip. A standard female luer is placed on the proximal end of each model. The catheter is coated with a lubricious, hydrophilic coating.
2. INDICATIONS FOR USE
Quick-Cross Select Support Catheters are intended to guide and support a guidewire during access of the coronary or peripheral vasculature, allow for wire exchanges and provide
a conduit for the delivery of saline solutions or diagnostic contrast agents.
3. CONTRAINDICATIONS
None known.
4. WARNINGS
Maximum Infusion Pressure: 300 psi. for 0.014" & 0.018" catheters and 500 psi for 0.035" catheters.
•
The catheter is designed and intended for one time use only. Do not re-sterilize and/or reuse.
•
• The catheter should only be used by physicians qualified to perform percutaneous vascular interventions.
5. PRECAUTIONS
• DO NOT resterilize or reuse this device, as these actions can compromise device performance or increase the risk of cross-contamination due to inappropriate reprocessing.
Reuse of this single use device could lead to serious patient injury or death and voids manufacturer warranties.
• Store in a cool, dry place. Protect from direct sunlight and high temperature (greater than 55°C or 131°F).
• Do not use if device or packaging is damaged.
• Use the catheter prior to the "Use By" date (Expiration Date) specified on the package.
6. ADVERSE EFFECTS
Vascular catheterization and/or vascular intervention may result in complications including but not limited to:
• Vessel dissection, perforation, rupture or total occlusion
• Infection
• Hematoma
• Unstable angina
• Embolism
• Hypo/hypertension
• Acute myocardial infarction
• Arrhythmia, including ventricular fibrillation
• Death
7. HOW SUPPLIED
The Spectranetics Quick-Cross Select Support Catheters are supplied STERILE. The devices are designated and designed for SINGLE USE ONLY and must not be resterilized
and/or reused.
7.1 Sterilization
• The sterility of the product is guaranteed only if the package is unopened and undamaged. Before use, visually inspect the sterile package to ensure that the seals have
not been broken. Do not use the catheter if the integrity of the package has been compromised. Do not use catheter if its "Use Before Date, " found on package labeling, has
been passed.
7.2 Inspection prior to use
• Before use, examine carefully for defects, all of the equipment to be used. Do not use any equipment if it is damaged.
P010263-03 03MAR20 (2020-03-03)
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician
Support Catheter
Table of Contents
Instructions for Use
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