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7.
ADVERSE EVENTS
Vascular catheterization and/or vascular interventions may result in complications including but not limited to:
•
Vessel dissection, perforation, rupture or total occlusion
•
Unstable angina
•
Embolism
•
Hypo/hypertension
•
Acute myocardial infarction
•
Arrhythmia, including ventricular brillation
•
Death
8.
HOW SUPPLIED
The Spectranetics Quick-Cross Support Catheters are supplied STERILE. The devices are designated and designed for SINGLE USE ONLY and must not be resterilized and/or reused.
8.1
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.
8.2
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.
•
Store in a cool, dry place. Protect from direct sunlight and high temperature (greater than 60°C or 140°F).
9.
COMPATIBILITY
•
See the table in Speci cations.
•
After use, dispose of all equipment in accordance with applicable speci c requirements relating to hospital waste, and potentially bio-hazardous materials.
10. DIRECTIONS FOR USE
Procedure Set-Up
•
Follow the "Directions for Use" section below.
Note: Follow instructions for use for all equipment to be used with the Quick-Cross® Support catheters. For example, guiding catheters, introducer sheaths, and guidewires.
1. Preparation: Using sterile technique, open the sterile package. Gently remove the protective hoop with the catheter from the pouch. Fill a sterile standard luer-lock syringe with sterile saline.
Before removing the catheter from the hoop, connect the syringe to the catheter proximal luer tting, ush the catheter and allow the saline to ll the hoop. Set catheter in hoop aside until ready
for use.
2. Insertion: Through a previously inserted, appropriately sized guiding catheter or introducer sheath, introduce the catheter over an appropriate sized guidewire (see speci cations) using
standard technique.
3. Advancement: Use uoroscopic guidance when advancing the catheter to the desired location within the vasculature.
4. Removal: Gently withdraw the catheter using standard technique, being careful to maintain guidewire position if the guidewire is to remain in place.
5. Infusion: To perform infusion, withdraw the guidewire and reference the chart below. Note: Do not exceed 300 psi inlet infusion pressure.
Quick-Cross Infusion Flow Rates (ml/second) at 150 and 300 psi Injection Pressures for Saline and Contrast Solutions
Model
518-032
518-065
518-033
518-034
518-035
518-066
518-036
518-037
518-038
* 75/25 Optiray 320 contrast / Sterile Saline mix
11. WARRANTY INFORMATION
Manufacturer's Limited Warranty
Manufacturer warrants that the Quick-Cross catheter is free from defects in material and workmanship when used by the stated "Use By" date and when package is unopened and undamaged immediately
before use. Manufacturer's liability under this warranty is limited to replacement or refund of the purchase price of any defective Quick-Cross catheter. Manufacturer will not be liable for any incidental,
special, or consequential damages resulting from use of the Quick-Cross catheter. Damage to the Quick-Cross catheter caused by misuse, alteration, improper storage or handling, or any other failure
to follow these Instructions for Use will void this limited warranty. THIS LIMITED WARRANTY IS EXPRESSLY IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. No person or entity, including any authorized representative or reseller of Manufacturer, has the authority to extend
or expand this limited warranty and any purported attempt to do so will not be enforceable against Manufacturer.
12. NON-STANDARD SYMBOLS
GW Compatibility
Distal Marker Spacing
Outer Diameter (O.D.)
Authorized Representative in the European Community
P001260-09
07Jan19
Quick-Cross® Support Catheter
Size
Length
0.014
135
0.014
150
0.018
90
0.018
135
0.018
150
0.035
65
0.035
90
0.035
135
0.035
150
(2019-01-07)
Sterile Saline
150 psi
300 psi
1.1
1.6
1.0
1.5
2.0
2.9
1.8
2.5
1.7
2.4
8.7
12.4
6.8
10.0
4.7
7.8
5.4
8.0
Tip Pro le
Sheath Compatibility
Working Length
Manufacturer
Instructions for Use
English / English
Contrast*
150 psi
300 psi
0.4
1.0
0.4
0.7
0.8
1.6
0.7
1.2
0.6
1.2
5.8
10.4
4.2
7.2
3.4
6.1
3.2
5.5
4
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