Philips PHOENIX Gebrauchsanweisung Seite 2

HOW SUPPLIED, STERILIZATION, AND EXPIRATION
The Phoenix Guidewire is packaged and sterilized individually. NOTE: Guidewire, length, diameter, tip and wire support con gurations are indicated on the product label. The Phoenix Guidewire
is sterilized using ethylene oxide gas. Each device is sterile if the sealed pouch is unopened and undamaged. All are intended for single use only and should not be reused or re-sterilized. Use
before the "Use by" dated printed on the package labels. Store in a dry, cool place.
INSPECTION OF PHOENIX GUIDEWIRE COMPONENTS
Prior to use, all equipment to be used for the procedure should be examined carefully for defects. Examine the packaging for cuts, tears, or other breach of the sterile barrier. Examine the Phoenix
Guidewire for bends, kinks or other damage. Do not use any defective guidewire
DIRECTIONS FOR USE:
1. Inspect guidewire prior to use for tip shape, bends, kinks, coil separation. If damaged, DO NOT USE.
2. Using sterile technique, localize and puncture the vessel with a needle cannula.
3. Remove the needle, leaving the cannula in place.
4. Insert distal end of the guidewire through the cannula and into vessel.
5. Remove the cannula, leaving the guidewire within the lumen of the vessel.
6. Pass the catheter over the guidewire within the lumen of the vessel under uoroscope guidance to the desired position.
7. With the guidewire in place, follow the instructions for use provided by the manufacture of the introducer, catheter or other devices, as well as the medical facility's standard procedure for
these types of devices.
DEVICE DISPOSAL:
The Phoenix Guidewire is disposable per hospital biohazard procedures.
Use Before Date
Store in a dry, dark, cool place
Do not use open or damaged packages
Volcano AtheroMed, Inc.
1530 O'Brien Drive STE A
Menlo Park CA 94025 USA
(800) 228-4728
(916) 638-8008
Manufactured for:
(916) 638-8112 fax
©2018 Volcano AtheroMed, Inc. All rights reserved.
ATHEROMED, PHOENIX, and the ATHEROMED and PHOENIX logos are trademarks or registered trademarks of Volcano AtheroMed, Inc. in the U.S. and other countries.
The PHOENIX ATHERECTOMY System and PHOENIX GUIDEWIRE (including components and/or methods thereof ) may be protected under one or more pending United States Patent Applications,
as well as corresponding international patent applications.
LIMITED WARRANTY AND DISCLAIMER
Volcano AtheroMed, Inc. warrants that reasonable care has been used in the design and manufacture of this medical device.
Handling, storage and preparation of this medical device as well as other factors relating to the patient, diagnosis, treatment, surgical procedures and other matters beyond the control of Volcano
AtheroMed, Inc. directly a ect this medical device and the results obtained from its use. Further, no representation or warranty is made that a Volcano AtheroMed, Inc. product will not fail. Volcano
AtheroMed, Inc disclaims responsibility for any medical complications – including death – directly or indirectly resulting from the use of this product. Except as expressly provided by this limited
warranty, VOLCANO ATHEROMED, INC. IS NOT RESPONSIBLE FOR ANY DIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, FAILURE OR MALFUNCTION OF ITS PRODUCTS
WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT OR OTHERWISE.
Volcano AtheroMed, Inc. assume no liability with respect to medical devices reused, reprocessed or resterilized and makes no warrants – expressed or implied – including but not limited to
merchantability of tness for a particular purpose with respect to such medical device.
THIS WARRANTY IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES NOT EXPRESSLY SET FORTH HEREIN, AND VOLCANO ATHEROMED, INC. MAKES NO WARRANTY – EXPRESS OR IMPLIED –
INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
INSTRUCTIONS FOR PROCEDURE
Nonpyrogenic
Content: One (1)
Do not Re-Sterilize
Volcano Europe BVBA/SPRL
Excelsiorlaan 41
B-1930 Zaventem, Belgium
+32.2.679.1076
Authorized Representative +32.2.679.1079 fax
2
Catalogue number
Sterilized using Ethylene Oxide
Prescription Only
Batch Code
Single Use Only