Baylis Medical RFP-100A Manuel D'instructions page 2

Instructions for Use), the Reusable RFP-100A connector cable can be used to
connect the catheter or wire to the Generator.
1. Connect the generator connector end of the cable to the isolated patient
connector port on the RFP-100A Generator as per the Generator Instructions
for Use. The generator connector end of the cable can be identified by the
blue strain relief (the device connector end has a black strain relief). The
Reusable RFP-100A connector cable uses a circular connector, keyed for
proper alignment. Gently line up the connector pins with the socket and push
in until the connector fits firmly into the socket. Any attempt to connect the
cable otherwise will damage the pins on the connector.
2. Do not use excessive force in connecting the cable to the generator. Use of
excessive force may result in damage to the connector pins.
3. Connect the device connector end of the cable to the RF Puncture Device.
The Reusable RFP-100A connector cable uses a circular connector, keyed
for proper alignment. Gently line up the connector pins with the RF Puncture
Device connector and push in until the connector fits firmly into the plug.
4. To disconnect the puncture device from the Connector Cable: Firmly grasp
the catheter connector (receptacle) end of the cable in one hand and gently
pull it straight out of the device connector.
5. To disconnect the cable from the generator, grasp the connector firmly and
gently pull it straight out of the socket.
XI. CLEANING AND STERILIZATION INSTRUCTIONS
DANGER
The Reusable RFP-100A Connector Cable is supplied sterile, however it must be
cleaned and sterilized before each subsequent use as described in this Instructions
for Use document. Failure to properly clean and sterilize the device can cause
patient injury and/or the communication of infectious diseases from one patient to
another.
IMPORTANT
The manufacturer recommends the user follow a quality control program for each
sterilization cycle that meets or exceeds American Operating Room Nurses
(AORN) Standards, Recommended Practices & Guidelines - 2000. This program
includes, but is not limited to recording:

Type of sterilizer and cycle used

Lot control number

Load contents

Exposure time and temperature, if not provided by a recording chart

Operator's name

Results of sterilization process monitoring (i.e. chemical, mechanical,
biological)
Cleaning and Decontamination
1. Ensure that blood and other contaminates do not dry on the Reusable RFP-
100A connector cable.
2. Visually inspect the cable for defect.
3. Rinse the cable with de-ionized water until colourless run-off water occurs.
Once the water runs clear, soak the cable (except for the connectors at the
ends of the cable) in de-ionized water at 22C-48C for 1 minute. Remove
the cable from the water and scrub it with a soft bristle brush until it is visually
clean.
Note: Do not let the connectors soak. Wipe them as necessary until they
are visually clean.
4. Soak the cable (except for the connectors) in an enzymatic cleaning solution
(such as Terg-A-Zyme) for 20 minutes. Ensure that the temperature of the
solution is below 55C. Scrub again with a soft bristle brush, and rinse
thoroughly using de-ionized water until all traces of detergent residue are
removed.
5. Visually inspect the parts for debris. If any is present repeat steps 3 and 4.
6. Dry the cable with a clean, dry, lint free towel.
7. Place the cable on a sterilization tray.
8. Consult referenced standards for proper packaging and storage of sterilized
product.
Sterilization
For a prevacuum sterilizer:
WRAPPED: 132C-135C (270F-275F) FOR 3-4 MIN.
UNWRAPPED: "FLASH' STERILIZATION 132C FOR 4 MIN.
NOTE:
Only the above cleaning and sterilization methods have been validated for the
Reusable RFP-100A connector cable. Single Use RFP-100A connector cables are
not meant for re-sterilization. No other cleaning and sterilization methods have
been tested. Failure to follow these instructions can cause patient injury and/or
the communication of infectious disease(s) from one patient to another.
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.
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.
Page 2 of 23
PROBLEM COMMENTS
Generator In order to
Alert successfully puncture
Messages tissue using
radiofrequency
energy, the entire
system must be
connected and all
devices must be in
good working order.
Connector The connectors are
Cable does designed to connect in
not fit into a specific way for
the Isolated safety reasons. If the
Patient connector "keys" are
Connector out of line, the
on the front connectors won't fit
panel of the together
generator
XIV. LABELING AND SYMBOLS
Manufacturer
Consult Instructions for
Use
Model number
Sterile using ethylene oxide
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.
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
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
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.
TROUBLESHOOTING
Ensure that all connections are made:
- puncture device to connector cable
- connector cable to generator
- generator to power outlet
- generator to grounding pad
Visually inspect the catheter/wire or cable for
damage. Immediately discard any
damaged equipment. If the problem persists
discontinue use.
For error/alert messages encountered while
attempting puncture, refer to the operator's
manual that accompanies the Generator. If
errors persist, attach a new connector cable.
If this solves the problem, discard the
damaged connector cable.
Check that the connector keys are lined up
in the proper orientation.
Ensure that the connectors are clean and
unobstructed.
Use By
Caution
Lot Number
Keep Away From
Sunlight
EU Authorized
Representative
EU Importer Do not
resterilize
OF SELLER'S VENDORS, APPOINTED
DMR RFX 3.3 V-11 16-Jul-2021