Baylis Medical DuoMode RFX-BAY-DUO-100 User manual

Page 1 of 2DMR RFX-BAY-DUO 3.3 V-2 12-Aug-2021
Instructions for Use
DuoMode™ Cable
English
Carefully read all instructions prior to use. Observe all contraindications, warnings
and precautions noted in these instructions. Failure to do so may result in patient
complications.
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a
physician.
I. DEVICE DESCRIPTION
The reusable DuoMode Cable is an extension cable that is used with Baylis
Medical approved radiofrequency puncture devices, the Baylis Medical Company
Radiofrequency Puncture Generator (RFP-100 Generator for RFX-BAY-DUO-100)
and to diagnostic equipment.
Detailed information concerning the Generator is contained in a separate manual
that accompanies the Generator (RFP-100 Generator Instructions for Use). In
addition, detailed information concerning the RF puncture devices is contained in
separate manuals that accompany these devices.
The DuoMode Cable has a four-pin connector on a cable that mates with the RFP
Generator and a puncture device connector port that accepts other Baylis RFP
connector cables that facilitates connection to the puncture device. The DuoMode
connector cable also has a Diagnostic Equipment Connector that consists of a
protected 2mm pin.
II. INDICATIONS FOR USE
The DuoMode Cable is intended to serve as an extension cable that is used with
the Baylis Medical radiofrequency puncture devices, the Baylis Medical Company
Radiofrequency Puncture Generator and diagnostic equipment.
III. CONTRAINDICATIONS
The DuoMode Cable is not recommended for use with any other RF generator.
IV. WARNINGS
•The DuoMode Cable is a reusable device. Failure to properly clean the
device can cause patient injury and/or the communication of infectious
disease(s) from one patient to another.
•The DuoMode Cable must only be used with Baylis RF Puncture Generators
and RF puncture devices. Attempts to use it with other RF Generators and
devices can result in electrocution of the patient and/or operator.
•Laboratory staff and patients can undergo significant x-ray exposure during
radiofrequency puncture procedures due to the continuous usage of
fluoroscopic imaging. This exposure can result in acute radiation injury as
well as increased risk for somatic and genetic effects. Therefore, adequate
measures must be taken to minimize this exposure.
V. PRECAUTIONS
•Do not attempt to use the DuoMode Cable or ancillary equipment before
thoroughly reading the accompanying Instructions for Use.
•Puncture procedures should be performed only by physicians thoroughly
trained in the techniques of RF powered puncture in a fully equipped
catheterization laboratory.
•Visually inspect the cable to ensure there is no cracking or damage to the
insulating material. Do not use the cable if there is any damage.
•The DuoMode Cable is intended for use with RF puncture devices only.
•Never disconnect the DuoMode Cable from the RF Puncture Generator while
the Generator is delivering RF power.
•Never disconnect the DuoMode Cable from the Generator by pulling on the
cable. Failure to disconnect the cable properly may result in damage to the
cable.
•Do not twist the DuoMode Cable while inserting or removing it from the
Isolated Patient Connector on the Generator. Twisting the cable may result
in damage to the pin connectors.
•Do not bend the cable. Excessive bending or kinking of the cable may
damage the integrity of the cable and may cause patient injury. Care must
be taken when handling the cable.
•Take precautions to limit the effects that the electromagnetic interference
(EMI) produced by the Generator may have on the performance of other
equipment. Check the compatibility and safety of combinations of other
physiological monitoring and electrical apparatus to be used on the patient
in addition to the Generator.
•Adequate filtering must be used to allow continuous monitoring of the surface
electrocardiogram (ECG) during RF power applications.
•During power delivery, the patient should not be allowed to come in contact
with ground metal surfaces.
•In order to prevent the risk of ignition make sure that flammable material is
not present in the room during RF power application.
Baylis Medical Company relies on the physician to determine, assess and
communicate to each individual patient all foreseeable risks of the Baylis Medical
Radiofrequency Puncture System.
VI. ADVERSE EVENTS
Adverse events associated with the use of this device are similar to those
indicated for the Baylis Medical Radiofrequency Puncture System.
VII. PRODUCT SPECIFICATIONS
Model Number
RFX-BAY-DUO-100
Generator Connector
4-pin (Plug)
Generator Connector Cable Colour
Black
Diagnostic Equipment Cable Colour
Red
Diagnostic Equipment Connector
Protected 2mm Pin (DIN 42802-2)
Puncture Device Connector Port
4-pin (receptacle)
VIII. INSPECTION PRIOR TO USE
Perform the following checks before the patient is presented for the procedure.
These tests will allow you to verify that the equipment you will use is in proper
working order. Do these tests in a sterile environment. Do not use defective
equipment.
KEY ITEMS
QUESTION?
WARNINGS AND EXPLANATIONS
Visual Check
Have you done
a visual check
on the entire
system?
Ensure connectors and the cable have no visible damage,
such as discoloration, cracks, label fading, cable splice, or
kinks. Do not use damaged equipment.
IX. EQUIPMENT REQUIRED
Puncture procedures should be performed in a specialized clinical setting which
may be equipped with a fluoroscopy unit, radiographic table, physiologic recorder,
emergency equipment and instrumentation for gaining vascular access.
X. DIRECTIONS FOR USE
Once the RF puncture device is properly positioned at the puncture site, and the
Generator is properly set up (following the instructions in the Generator
Instructions for Use), the DuoMode Cable can be used to connect the catheter or
wire to the Generator.
Baylis Medical Company Inc.
5959 Trans-Canada Highway
Montreal, Quebec, Canada, H4T 1A1
Tel: [phone] Fax: (514) 488-
7209
www.baylismedical.com
© Copyright Baylis Medical Company Inc., 2021
DuoMode and the Baylis Medical logo are trademarks and/or registered
trademarks of Baylis Medical Company Inc. In the United States of
America and/or other countries. All other trademarks or registered
trademarks are property of their respective owners.
Generator
Connector
Diagnostic
Equipment
Connector
Puncture
Device
Connector
Port

Page 2 of 2 DMR RFX-BAY-DUO 3.3 V-2 12-Aug-2021
Connecting the DuoMode cable
1. Connect the Generator connector end (black cable) of the DuoMode Cable
to the isolated patient connector port on the RF Puncture Generator as per
the Generator Instructions for Use. The DuoMode Cable Generator
Connector 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.
For the RFX-BAY-DUO-100 only: Secure the screw-on locking ring
mechanism of the Generator Connector.
2. Connect the Diagnostic Equipment Connector (red cable) to the input of the
diagnostic equipment.
3. Connect the Generator connector end of the RFP Connector cable (used to
connect the puncture device) to the Puncture Device Connector Port on the
DuoMode cable. Follow the RFP Connector Cable Instructions for Use.
Note: The generator connector of the RFP Connector cable can plug directly into
the isolated patient connector on the Generator, if the DuoMode Cable is not
used.
4. Do not use excessive force in connecting any of the cables. Use of excessive
force may result in damage to the connector pins.
5. Connect the device connector end of the RFP Connector cable to the RF
Puncture Device, according to the RFP Connector cable Instructions for Use.
Switching the DuoMode Cable
6. To connect the puncture device to the Diagnostic Equipment, press the
rocker switch down towards the Mapping symbol.
7. To connect the puncture device to the RF Puncture Generator, press the
rocker switch down towards the Generator symbol.
Do not activate RF delivery on the generator while the switch is set to the
Mapping setting.
Do not change the rocker switch position while RF is being delivered.
Disconnecting the DuoMode Cable
8. To disconnect the puncture device from the RFP Connector Cable, follow the
RFP Connector Cable Instructions for Use.
9. To disconnect the RFP Connector Cable from the DuoMode cable, follow the
RFP Connector Cable Instructions for Use.
10. To disconnect the Generator Connector –
For the RFX-BAY-DUO-100 only: rotate the locking rings of the Generator
Connector counter clockwise to unlock.
11. To disconnect the Generator Connector, grasp the Generator Connector
firmly and gently pull it straight out of the socket.
12. To disconnect the Diagnostic Equipment, grasp the Diagnostic Equipment
Connector firmly and gently pull it straight out of the socket.
XI. CLEANING AND STERILIZATION INSTRUCTIONS
The DuoMode cable is a non-body contact device and therefore is NOT sterile and
CANNOT be sterilized. If cleaning is necessary, the surface of the DuoMode cable
can be cleaned with a damp low lint cloth with non-abrasive detergent dissolved in
water. Dry the surface after wiping down. Do not spray or pour liquids directly on
the DuoMode Cable.
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.
PROBLEM COMMENTS TROUBLESHOOTING
Generator
Alert
Messages
In order to successfully
puncture tissue using
radiofrequency energy,
the entire system must
be connected and all
devices must be in good
working order.
Ensure that all connections are made:
- puncture device to connector cable
- connector cable to DuoMode cable
- DuoMode 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.
DuoMode
Cable does
not fit into the
Isolated
Patient
Connector on
the front panel
The connectors are
designed to connect in a
specific way for safety
reasons. If the
connector “keys” are out
of line, 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.
of the
generator
XIV. LABELING AND SYMBOLS
Manufacturer Caution
Consult Instructions for Use Lot Number
Model number
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.
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.