Philips PV018OTW Instrucciones De Uso página 17

W : Total Power (mW)
0
PD: Pulse Duration (μs)
PRF: Pulse Repetition Frequency (Hz)
Limited warranty:
Subject to the conditions and limitations on liability stated herein, Philips warrants that
the Reconnaissance .018 PV Digital IVUS catheter (the "catheter"), as so delivered, shall
materially conform to Philips' then current specification for the catheter upon receipt
for a period of one year from the date of delivery. Any liability of Philips with respect to
the catheter or the performance thereof under any warranty, negligence, strict liability
or other theory will be limited exclusively to catheter replacement or, if replacement
is inadequate as a remedy or, in Philips' opinion, impractical, to refund of the fee paid
for the catheter. Except for the foregoing, the catheter is provided "as is" without
warranty of any kind, expressed or implied, including without limitation, any warranty
of fitness, merchantability, and fitness for a particular purpose of noninfringement.
Further, Philips does not warrant, guarantee, or make any representations regarding
the use, or the results of the use, of the catheter or written materials in terms of
correctness, accuracy, reliabilty, or otherwise. Licensee understands that Philips is not
responsible for and will have no liability for any items or any services provided by any
persons other than Philips. Philips shall have no liability for delays or failures beyond its
reasonable control.
Additionally, this warranty does not apply if:
1. The catheter is used in a manner other than described by Philips in the Instructions
For Use supplied with the catheter.
2. The catheter is used in a manner that is not in conformance with purchase
specifications or specifications contained in the Instructions For Use.
3. The catheter is re-used or re-sterilized.
4. The catheter is repaired, altered, or modified by other than Philips authorized
personnel or without Philips authorization.
If claims under this warranty become necessary, contact Philips for instructions and
issuance of a Return Material Authorization number if the catheter is to be returned.
Equipment will not be accepted for warranty purposes unless the return has been
authorized by Philips.
Patent: www.philips.com/patents
An electronic copy of these instructions can be found at: www.philips.com/IFU
The summary of safety and clinical performance will be available in the European
database on medical devices (EUDAMED) at the following URL
https://ec.europa.eu/tools/eudamed
REACH declaration:
REACH requires Philips Healthcare (PH) to provide chemical content information for
"substances of Very High Concern (SVHC) if they are present above 0.1% of the product
weight. The SVHC list is updated on a regular basis. Therefore, refer to the following
Philips REACH website for the most up-to-date list of products containing SVHC above
the threshold: www.philips.com/REACH
This product is licensed to the customer for single use only.
Additional questions regarding this product should be directed to Philips in the U.S.A.:
Legal Manufacturer:
Volcano Corporation
3721 Valley Centre Drive, Suite 500
San Diego, CA 92130 USA
(800) 228-4728
IGTD.CustomerInquiry@philips.com
USA & Canada:
(800) 228-4728
IGTD.CustomerInquiry@philips.com
International:
vecomplaints@philips.com or
IGTD.CustomerInquiry@philips.com
European Authorized Representative
Volcano Europe SA/NV
Excelsiorlaan 41
B-1930 Zaventem, Belgium
Telephone: +32.2.679.1076
Fax: +32.2.679.1079
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EC REP