Spectranetics Quick-Cross Select 518-085 Mode D'emploi page 4

8. COMPATIBILITY
Model
(Ref)
518-085
518-087
518-089
518-091
518-093
518-077
518-079
518-081
518-083
9. PROCEDURE SET-UP AND DIRECTIONS FOR USE
Note: Follow instructions for use for all equipment to be used with the Quick-Cross Select Support Catheter.
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 fitting, flush the catheter and allow the saline to fill 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 appropriately sized guidewire (see
specifications) using standard technique.
3. Advancement: Use fluoroscopic 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.
Infusion: To perform infusion, withdraw the guidewire and reference the specifications for maximum infusion pressure.
Note: Do not exceed the maximum infusion pressures.
After use, dispose of all equipment in accordance with applicable requirements relating to hospital waste, and potentially bio-hazardous materials.
10. MANUFACTURER'S LIMITED WARRANTY
Manufacturer warrants that the Quick-Cross Select 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 Select.
Manufacturer will not be liable for any incidental, special, or consequential damages resulting from use of the Quick-Cross Select. Damage to the Quick-Cross Select 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.
11. NON-STANDARD SYMBOLS
Distal Marker Spacing
Shape
Importer
GW Compatibility
Maximum OD
Maximum PSI/kPa
Sheath Compatibility
Working Length
Quantity
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
P010263-03 03MAR20 (2020-03-03)
Product Features & Model Numbers Table
Working Tip Hydrophilic
Length Shape / Type Coating Length
135 cm Angled
100 cm
150 cm Angled
90 cm Angled 60 cm
135 cm Angled
100 cm
150 cm Angled
65 cm Angled 45 cm
90 cm Angled 70 cm
135 cm Angled 115 cm
150 cm Angled 130 cm
Support Catheter
GW Min. Guide Min.
Compatibility I.D. Sheath I.D.
0.014"
5F 4F
0.36 mm
0.018"
5F 4F
0.46 mm
0.035"
N/A 5F
0.89 mm
Instructions for Use
Marker
Maximum Throw
Band
Catheter O.D. Angle
Spacing
3.2F
0.042" 15 mm 45°
1.07 mm
3.4F
0.044" 15 mm 45°
1.12 mm
4.5F
0.059" 50 mm 45°
1.50 mm
English / English
QTY
4