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DMR DEX 3.3 V-5 25-May-2022 (DEX-14)
Note:
Some pins may be unused for certain catheter/cable combinations.
3.
To disconnect the cable from the catheter: while securely holding the
catheter, grasp the catheter connector of the cable and gently pull straight
out of the receptacle. The connector housing will slide back and disengage
the locking mechanism.
4.
To disconnect the cable from the catheter input module: firmly grasp one of
the diagnostic EP equipment connectors and pull it straight out of the socket.
Repeat for remaining connectors.
XI.
CLEANING AND STERILIZATION INSTRUCTIONS
The Electrophysiology Cable (DEX-14) is a single-use device supplied sterile and
should not be re-sterilized or reused. The Electrophysiology Cable (DEX-14) can
be considered sterile only if the package is not opened or damaged prior to use.
XII.
CUSTOMER SERVICE AND PRODUCT RETURN INFORMATION
If you have any problems with or questions about Baylis Medical Equipment
contact our technical support personnel.
NOTES:
1.
In order to return products you must have a return authorization number
before shipping the products back to Baylis Medical Company Inc.
2.
Baylis Medical will not accept any piece of used equipment without a
sterilization certificate. Ensure that any product being returned to Baylis
Medical has been cleaned, decontaminated and sterilized as per user
instructions before returning it for warrantied service.
XIII.
TROUBLESHOOTING
The following table is provided to assist the user in diagnosing potential
problems.
PROBLEM
COMMENTS
TROUBLESHOOTING
Electrocardiography
signals
are not being
displayed
The diagnostic EP
equipment must be set up
to match configuration in
which the cable connectors
are plugged into the
catheter input module.
Check that the cable
connectors are plugged into
the catheter input module
sockets that correspond to
the settings of the diagnostic
EP equipment.
Connector Cable
does not fit into the
connector of the
EPstar catheter
.
The connectors are
designed to connect in a
specific way for safety
reasons. If the connector
“keys” are not aligned, the
connectors won’t fit
together
Check that the connector
keys are lined up in the
proper orientation.
Ensure that the connectors
are clean and unobstructed.
There are two models of
Electrophysiology Cables
with different connector pin
configurations.
Ensure that the correct cable
is chosen for the EPstar
catheter (refer to Product
Specification table).
XIV.
LABELING AND SYMBOLS
Manufacturer
Use By
Refer to instruction
manual/booklet
Caution
Model number
Lot Number
Sterilized using ethylene
oxide
Keep Away From Sunlight
Do Not Use if Packaging
is Damaged
Caution: Federal (U.S.A.)
law restricts this device to
sale by or on the order of
a physician.
Do not re-use
Do not re-sterilize
XV.
LIMITED WARRANTY – DISPOSABLES AND 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 WARRANTIES, WHETHER EXPRESS OR IMPLIED,
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,
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 RESELLERS AS THIRD-PARTY
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. 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