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DMR 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: (514) 488-9801/ (800) 850-9801 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