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PROBLEM
COMMENTS
Connector
The connectors are
Cable does not
designed to connect in a
fit into the
specific way for safety
Isolated Patient
reasons. If the connector
"keys" are out of line, the
Connector on
connectors won't fit
the front panel
of the
together.
generator
Generator Error
In order to successfully
Messages
perforate tissue using RF
energy, all devices must
be properly connected
and in good working
order.
Wire breaks or
Breaks and kinks in the
kinks
VersaCross RF Wire are
a potential cause of
patient injury.
DISPOSAL OF WASTE
Treat the used device(s) as biohazardous waste and dispose of in compliance
with standard hospital procedures.
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
Follow Instructions
for Use
Maximum guidewire
outside diameter
that can be used
with this device
Caution: Federal
(U.S.A.) law
restricts this device
to sale by or on the
order of a
physician.
Page 4 of 48
TROUBLESHOOTING
Check that the connector keys
are lined up in the proper
orientation.
Ensure that all connections are
made i.e.:
- VersaCross RF Wire to
Connector Cable
- Connector Cable to Baylis RF
Generator
- Baylis RF Generator to power
outlet
- Baylis RF Generator to
grounding pad (not
included)
Visually inspect the VersaCross
RF Wire and Connector Cable
for damage. Immediately discard
any damaged devices. If
problem persists, discontinue
use.
For error messages encountered
while attempting RF puncture,
refer to the Instructions for Use
that accompanies the Baylis RF
Generator.
Discard immediately.
Catalogue number
Single use – Do not
reuse
Lot number
Do not use if package
is damaged and
consult instructions for
use
Keep away from
sunlight
Non-pyrogenic: The
RF wire and dilator are
non-pyrogenic unless
packaging is opened or
damaged
Do not resterilize
LIMITED WARRANTIES
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 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.
LIMITATION OF LIABILITY FOR DAMAGES
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,
REVENUE, MATERIALS, 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 DISCLAIMS ALL LIABILITY RELATIVE TO 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 VENDORS, APPOINTED
DISTRIBUTORS
AND
OTHER
AUTHORIZED
BENEFICIARIES. EACH PROVISION HEREOF WHICH 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
RESELLERS
AS
THIRD-PARTY
BMC'S LIABILITY SHALL BE LIMITED TO THE
The shelf life of the product
90 days from the shipment date
DMR VXAK-FD (PCS) 3.3 V-A NA
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