Français - Baylis Medical PowerWire Instructions For Use Manual

TM
PowerWire RF Breaks and kinks in the
TM
GuideWire breaks
PowerWire
or kinks. GuideWire are a potential
cause of patient injury.
XIV. LABELING AND SYMBOLS
o
10C
LIMITED WARRANTY – DISPOSABLES AND
XV.
ACCESSORIES
Baylis Medical Company Inc. (BMC) warrants its Disposable and Accessory
products against defects in materials and workmanship. BMC warrants that
sterile products will remain sterile for a period of time as shown on the label
as long as the original package remains intact. Under this Limited Warranty,
if any covered product is proved to be defective in materials or
workmanship, BMC will replace or repair, in its absolute and sole discretion,
any such product, less any charges to BMC for transportation and labor
costs incidental to inspection, removal or restocking of product. The length
of the warranty is: (i) for the Disposable products, the shelf life of the
product, and (ii) for the Accessory products, 90 days from shipment date.
This limited warranty applies only to new original factory delivered products
that have been used for their normal and intended uses. BMC's Limited
Warranty shall not apply to BMC products which have been resterilized,
repaired, altered, or modified in any way and shall not apply to BMC
products which have been improperly stored or improperly cleaned,
installed, operated or maintained contrary to BMC's instructions.
DISCLAIMER AND LIMITATION OF LIABILITY
THE LIMITED WARRANTY ABOVE IS THE SOLE WARRANTY
PROVIDED BY SELLER. SELLER DISCLAIMS ALL OTHER
Page 4 of 23
attach a new connector cable.
If this solves the problem,
discard the damaged
connector cable.
Discard immediately
RF
Manufacturer
Sterile using ethylene oxide
Use By
Caution
Consult Instructions for Use
EU Authorized Representative
Model number
Caution: Federal (U.S.A.) law
restricts this device to sale by or
on the order of a physician.
Do not reuse
Lot Number
Do Not Use if Packaging is
Damaged
Keep Away From Sunlight
Minimum Storage
o
Temperature 10C
Only for EU member states:
Use of this symbol indicates that
the product must be disposed of
in a way that complies with local
and national regulations. For
questions regarding recycling of
this device please contact your
distributor
Non-Pyrogenic
WARRANTIES, WHETHER
INCLUDING ANY WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR USE OR PURPOSE.
THE REMEDY SET FORTH HEREIN SHALL BE THE
EXCLUSIVE REMEDY FOR ANY WARRANTY CLAIM, AND
ADDITIONAL DAMAGES, INCLUDING CONSEQUENTIAL
DAMAGES OR DAMAGES FOR BUSINESS INTERRUPTION
OR LOSS OF PROFIT,
ANTICIPATED SAVINGS, DATA, CONTRACT, GOODWILL OR
THE LIKE (WHETHER DIRECT OR INDIRECT IN NATURE) OR
FOR ANY OTHER FORM OF INCIDENTAL, OR INDIRECT
DAMAGES OF ANY KIND, SHALL NOT BE AVAILABLE.
SELLER'S MAXIMUM CUMULATIVE LIABILITY RELATIVE TO
ALL OTHER CLAIMS
OBLIGATIONS UNDER ANY INDEMNITY, WHETHER OR NOT
INSURED, WILL NOT EXCEED THE COST OF THE
PRODUCT(S) GIVING RISE TO THE CLAIM OR LIABILITY.
SELLER DISCLAIMS ALL
GRATUITOUS INFORMATION OR ASSISTANCE PROVIDED
BY, BUT NOT REQUIRED OF SELLER HEREUNDER. ANY
ACTION AGAINST SELLER MUST BE BROUGHT WITHIN
EIGHTEEN (18) MONTHS AFTER THE CAUSE OF ACTION
ACCRUES. THESE DISCLAIMERS AND LIMITATIONS OF
LIABILITY WILL APPLY REGARDLESS OF ANY OTHER
CONTRARY PROVISION HEREOF AND REGARDLESS OF
THE FORM OF ACTION, WHETHER IN CONTRACT, TORT
(INCLUDING NEGLIGENCE AND STRICT LIABILITY) OR
OTHERWISE, AND FURTHER WILL EXTEND TO THE
BENEFIT OF SELLER'S
DISTRIBUTORS AND OTHER AUTHORIZED RESELLERS AS
THIRD-PARTY BENEFICIARIES. EACH PROVISION HEREOF
WHICH PROVIDES FOR A LIMITATION OF LIABILITY,
DISCLAIMER OF WARRANTY
EXCLUSION OF DAMAGES
INDEPENDENT OF ANY OTHER PROVISION AND IS TO BE
ENFORCED AS SUCH.
IN ANY CLAIM OR LAWSUIT FOR DAMAGES ARISING FROM
ALLEGED BREACH OF
CONTRACT, NEGLIGENCE, PRODUCT LIABILITY OR ANY
OTHER LEGAL OR EQUITABLE THEORY, THE BUYER
SPECIFICALLY AGREES THAT BMC SHALL NOT BE LIABLE
FOR DAMAGES OR FOR LOSS OF PROFITS, WHETHER
FROM BUYER OR BUYER'S CUSTOMERS. BMC'S LIABILITY
SHALL BE LIMITED TO THE PURCHASE COST TO BUYER OF
THE SPECIFIED GOODS SOLD BY BMC TO BUYER WHICH
GIVE RISE TO THE CLAIM FOR LIABILITY.
No agent, employee or representative of Baylis Medical has the authority to
bind the Company to any other warranty, affirmation or representation
concerning the product.
This warranty is valid only to the original purchaser of Baylis Medical
products directly from a Baylis Medical authorized agent. The original
purchaser cannot transfer the warranty.
Use of any BMC product shall be deemed acceptance of the terms and
conditions herein.
The warranty periods for Baylis Medical products are as follows:
Disposable Products The shelf life of the product
Accessory Products 90 days from the shipment date
MC
PowerWire Radiofrequency GuideWire Kit
Français
Lire attentivement toutes les directives avant l'utilisation. Respecter toutes
les contre-indications, mises en garde et précautions indiquées dans ces
directives. Leur non-respect peut engendrer des complications au patient.
Attention : la loi fédérale (États-Unis) limite la vente de cet appareil à un
médecin ou sur prescription médicale.
I. DESCRIPTION DU DISPOSITIF
MC
Le PowerWire RF GuideWire Kit comprend le PowerWire
GuideWire et le RFP-100A Connector Cable.
MC
Le PowerWire Radiofrequency GuideWire doit être utilisé avec un Baylis
Radiofrequency Puncture Generator (Baylis RF Générateur) et un Baylis
Câble Connecteur approuvés.
MC
Le PowerWire Radiofrequency GuideWire fournit une puissance
Radiofrequency (RF) en mode monopolaire entre l'électrode distale et une
électrode du DIP (Disposable Indifferent [Dispersive] Patch) externe et
disponible dans le commerce, conforme aux normes IEC 60601-2-2. Le
MC
PowerWire RF GuideWire est connecté au Baylis Radiofrequency
Puncture Generator par l'intermédiaire du Baylis Câble Connecteur.
DMR EWK 3.3 V-6 08-Mar-2018
EXPRESS OR IMPLIED,
REVENUE, MATERIALS,
AND LIABILITIES, INCLUDING
LIABILITY RELATIVE
VENDORS, APPOINTED
OR CONDITION
IS SEVERABLE
WARRANTY, BREACH
MC
Radiofrequency
TO
OR
AND
OF