Idiomas disponibles
Idiomas disponibles
at the distal sheath tip or inside the sheath lumen. Also aspirate when
removing the transseptal device or dilator.
4. Removing Steerable Sheath
Straighten distal end of sheath as much as possible prior to removal.
After removal of the sheath, use standard technique to achieve hemostasis.
Discard all kit equipment after removal from body.
CLEANING AND STERILIZATION INSTRUCTIONS
Do not clean or re-sterilize the SureFlex Steerable Guiding Sheath kit. The
SureFlex Steerable Guiding Sheath kit is intended for single use only.
CUSTOMER SERVICE AND PRODUCT RETURN INFORMATION
If you have any problems with or questions about Baylis Medical Equipment
contact our technical support personnel.
Baylis Medical Company Inc.
5959 Trans-Canada Highway
Montreal, Quebec, Canada, H4T 1A1
Phone: (514) 488-9801 or (800) 850-9801
Fax: (514) 488-7209
www.baylismedical.com
NOTES:
1.
In order to return products you must have a return authorization number
before shipping the products back to Baylis Medical Company. Product
Return Instructions will be provided to you at this time.
2.
Ensure that any product being returned to Baylis Medical has been
cleaned, decontaminated and/or sterilized as indicated in the Product
Return Instruction before returning it for warrantied service. Baylis Medical
will not accept any piece of used equipment that has not been properly
cleaned or decontaminated as per the Product Return Instructions.
LABELING AND SYMBOLS
Manufacturer
Sterile using ethylene
oxide
Use By
Caution
Keep Away from Sunlight
Consult Instructions for
Use
Model number
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of
a physician.
Maximum guidewire outside diameter that can be used with this device
LIMITED WARRANTIES
Disposables and Accessories
Baylis Medical Company (BMC) warrants that its products are free from defects in
original workmanship and materials.
remain sterile for a period of time as shown on the label as long as the original
package remains intact. The SureFlex Steerable Guiding Sheath kit is designed
for single use only. The SureFlex Steerable Guiding Sheath kit is not designed for
reuse. If any BMC product is proved to be defective in original workmanship or
original materials, BMC, in its absolute and sole discretion, will replace or repair
any such product, less charges for transportation and labour costs incidental to
inspection, removal or restocking of product.
This limited warranty applies only to 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 installed, operated or maintained contrary to BMC s
instructions.
DISCLAIMER AND EXCLUSION OF OTHER WARRANTIES
The limited warranty above is the sole warranty provided by Seller. Seller
disclaims all other warranties, whether express or implied, including any warranty
of merchantability or fitness for a particular use or purpose.
XIV.
LIMITATION OF LIABILITY FOR DAMAGES
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 WARRANTIES, WHETHER
EXPRESS
OR
IMPLIED,
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
Page 2 of 12
Single Use
Do not reuse
Lot Number
Do Not Re-Sterilize
Do Not Use if Packaging is Damaged
EU Authorized Representative
Non-Pyrogenic
BMC warrants that sterile products will
INCLUDING
ANY
WARRANTY
OR
DAMAGES
FOR
BUSINESS
INTERRUPTION
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 AND LIABILITIES, INCLUDING 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
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 VENDORS,
APPOINTED DISTRIBUTORS AND OTHER AUTHORIZED RESELLERS AS
THIRD-PARTY
PROVIDES FOR A LIMITATION OF LIABILITY, DISCLAIMER OF WARRANTY
OR CONDITION OR EXCLUSION OF DAMAGES IS SEVERABLE AND
INDEPENDENT OF ANY OTHER PROVISION AND IS TO BE ENFORCED AS
SUCH.
IN ANY CLAIM OR LAWSUIT FOR DAMAGES ARISING FROM ALLEGED
BREACH OF WARRANTY, 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.
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
Accessory Products
Francais_______________
Lire attentivement toutes les directives avant l utilisation. Respectez toutes les
contre-indications, avertissements et précautions indiqués dans ces directives.
Leur non-respect risque de causer des complications pour le patient.
La compagnie Baylis Médical se fie sur le médecin pour déterminer, évaluer et
communiquer à chaque patient tous les risques potentiels de la procédure.
AVERTISSEMENT : EN VERTU DE LA LOI FÉDÉRALE AMÉRICAINE, CE
DISPOSITIF NE PEUT TRE VENDU QUE PAR UN MÉDECIN OU SUR L AVIS
D UN MÉDECIN
I.
DESCRIPTION DU DISPOSITIF
La SureFlex Steerable Guiding Sheath kit est munie de trois composantes : une
gaine, un dilatateur et un fil guide avec un bout-J.
La SureFlex Steerable Guiding Sheath est conçue pour facilement et sûrement
effectuer des cathétérisations et des angiographies de localisations et chambres
spécifiques du c ur. La gaine fournie un control supérieur du torque et est
flexible. Le bout radiopaque maximise la visualisation de la gaine durant sa
manipulation.
Le dilatateur fourni un support pour la gaine et a un bout conique.
II.
INDICATIONS D UTILISATION
La trousse de gaine orientable SureFlex Steerable Guiding Sheath kit est indiquée
pour l introduction de divers cathéters cardiovasculaires jusqu au c ur, y compris
le côté gauche du c ur, à travers le septum interauriculaire.
III.
AVERTISSEMENTS
Le personnel de laboratoire et les patients peuvent subir une exposition aux
rayonnements considérables pendant les interventions de perforation par
radiofréquences en raison de l usage continu de la radioscopie. Cette
exposition peut causer une blessure de rayonnement grave et augmenter le
risque d effets somatiques et génétiques. Des mesures appropriées doivent
donc être prises pour réduire cette exposition au minimum.
La SureFlex Steerable Guiding Sheath kit est conçue pour un usage simple
sur un patient. N essayez pas de stériliser et réutiliser la SureFlex Steerable
Guiding Sheath kit. La réutilisation peut causer des blessures au patient et/ou
la transmission de maladies infectieuses entre patients. Car autrement, le
patient pourrait être exposé à des complications.
Assurez-vous que tout l air soit enlevé de la gaine avant de perfuser par le
port sur le côté.
Soyez attentif en enlevant le dilatateur et les cathéters de la gaine.
N essayez pas d insérer la gaine directement dans la peau sans le dilatateur,
ceci pourrait causer des dommages au vaisseau.
S'il est retiré par une canule d'aiguille de métal, le fil-guide pourrait être
endommagé.
Assurez
une
l intervention.
Administrez au patient une perfusion continue de soluté physiologique
hépariné, tant que l introducteur se trouve dans le vaisseau sanguin.
OF
Afin de limiter l effet de succion lors du retrait, retirez ou aspirez lentement les
composants. Ne pas aspirer si un fil est passé directement dans la valve.
Évitez tout contact avec d autres liquides que le sang, l alcool isopropylique,
les solutions de contraste ou le soluté physiologique.
OR
LOSS
OF
PROFIT,
REVENUE,
DISCLAIMS
ALL
LIABILITY
RELATIVE
BENEFICIARIES.
EACH
PROVISION
BMC S LIABILITY SHALL BE LIMITED TO THE
The shelf life of the product
90 days from the shipment date
surveillance
hémodynamique
DMR TSK 3.3 V-11 10-Oct-2020
MATERIALS,
TO
GRATUITOUS
HEREOF
WHICH
_____
___
continue
durant
toute
