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LBL 61928 Rev B, Instructions for Use EU (February 2018)
EN
Symbol
Definition
Do not re-use
Use by date
Sterilized using irradiation
Caution
Manufacturer
Do not use if package is damaged
Keep dry
Authorized Representative in the European Community
Keep away from heat
Batch code
Catalogue number
Do not resterilize
the recommended balloon overlap is at least 1 cm
to prevent geographic miss.
Caution: Care must
be taken not to exceed 180 pulses in the same
treatment segment.
9. Perform a completion arteriogram to assess post
intervention result.
10. Deflate the device and confirm that the balloon is fully
deflated prior to removing the IVL Catheter.
11. Remove the IVL Catheter. If there is difficulty in
removing the device through the hemostatic valve due
to the lubricity, gently grasp the catheter with sterile
gauze.
12. Inspect all components to ensure that the catheter is
intact. If a device malfunction occurs or any defects are
noted on the inspection, flush the guide wire lumen
and clean the outer surface of the catheter with saline,
store the catheter in a sealed plastic bag, and contact
Shockwave Medical, Inc. for further instructions.
Caution: IVL Catheter once pulled out of the body
should not be reinserted for additional inflation or
lithotripsy treatments. Balloon can be damaged in
the process.
Patient Information
Physicians should instruct patients to seek medical
attention immediately for signs and symptoms of
decreased peripheral blood flow. There are no known
limitations to normal daily activities. Patients should
be instructed to comply with the medical regimen as
prescribed by their physician.
Return of Devices
If any portion of the Shockwave Medical IVL System fails
prior to or during a procedure, discontinue use and
contact local representative and/or email complaints@
shockwavemedical.com.
Patents: www.shockwavemedical.com/patents
Symbol
Definition
Non-pyrogenic
Consult instructions for use
Contains 1 unit (Contents: 1)
Recommended Guidewire
Recommended Introducer Sheath
Balloon Diameter
Balloon Working Length
Catheter Working Length (Usable Length, UL)
Caution: Federal (USA) Law restricts this device to sale
by or on the order of a physician.
Conformité Européene
Patents. Refer to
www.shockwavemedical.com/patents
Intravascular Lithotripsy
PAT
UL
0086
MedPass SAS
95 bis Boulevard Pereire
75017 Paris
France
Shockwave Medical, Inc.
48501 Warm Springs Blvd., Suite 108
Fremont, CA 94539, USA
www.shockwavemedical.com
IVL
