Boston Scientific Stingray LP Instrucciones De Uso página 5

9. Tighten the hemostatic Y-adapter to create a seal around the Stingray LP Catheter.
Do not over-tighten.
10. Advance the Stingray LP Catheter over the guidewire using fluoroscopic guidance.
Position the Stingray LP Catheter ports (using the radiopaque markers) at the
target location.
11. Exchange the guidewire for a shaped guidewire (~45˚ bend at the distal
1.5 mm segment).
12. Connect the balloon inflation device to the 3-way stopcock and purge the stopcock
with contrast medium mixture.
13. Inflate the balloon to 3 atm – 4 atm (304 kPa – 405 kPa).
14. Adjust the fluoroscopic view until the balloon is shown at its minimum width.
15. Steer the shaped guidewire through the desired port by slowly rotating the shaped
guidewire immediately proximal to the marker band until the shaped guidewire
begins to exit the port.
16. Assess proper guidewire position and direction.
17. If the guidewire position or direction is incorrect, target the other side port by
steering the shaped guidewire through the desired port by slowly rotating the
shaped guidewire immediately proximal to the marker band until the shaped
guidewire begins to exit the port.
18. Advance the shaped guidewire through the port as needed.
19. After completing the procedure, deflate the balloon, withdraw the Stingray LP
Catheter and discard according to Disposal section.
Guidewire Trapping Technique
An additional balloon catheter or exchange device can be used in the guide catheter
to facilitate exchange of the Stingray LP with another therapeutic device (Guidewire
Trapping Technique): Bench testing has shown that one Stingray LP Catheter and one
3.0 mm x 20 mm (or smaller) MR balloon catheter with a max shaft OD of 0.036 in (0.91 mm)
can be inserted simultaneously into a 7F [minimum 0.080 in (2.0 mm) ID] guide catheter.
Care should be used when attempting to use two balloon catheters simultaneously in a
guide catheter; this technique was not clinically evaluated for safety and effectiveness in
a clinical trial. Balloon catheters with a diameter greater than those mentioned have not
been tested for simultaneous use in a single guide catheter.
Disposal
To minimize the risk of infection or microbial hazards after use, dispose device and
packaging as follows: After use, device and packaging may contain biohazardous
substances. Any device and packaging that came into contact with biohazardous
substances should be treated and disposed of as biohazardous waste or be treated
and disposed of in accordance with any applicable hospital, administrative, and/or
local government regulations. Use of a biohazardous container with biological hazard
symbol is recommended. Untreated biohazardous waste should not be disposed of in
the municipal waste system.
Post-Procedure
Any serious incident that occurs in relation to this device should be reported to the
manufacturer and relevant local regulatory authority.
INFORMATION TO BRIEF THE PATIENT
The following sections/clauses in the IFU contain information that may be useful for
briefing the patient prior to use of this device:
• Clinical Benefit Statement
• Adverse Events statements with potential relevance to the patient are in italics
Patients should be informed on post-procedure medications.
WARRANTY
For device warranty information, visit (www.bostonscientific.com/warranty).
Stingray LP and CrossBoss are trademarks of Boston Scientific Corporation or its affiliates.
All other trademarks are the property of their respective owners.
EU Importer: Boston Scientific International B.V., Vestastraat 6, 6468 EX Kerkrade,
The Netherlands
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Black (K) ∆E ≤5.0