Baylis Medical DuoMode RFX-BAY-DUO-100A Instrucciones De Uso

Instructions for Use
DuoMode™ Cable
© Copyright Baylis Medical Company Inc., 2018
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. Patents pending
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
Radiofrequency Puncture Generator (RFP-100A) and diagnostic equipment.
Detailed information concerning the Generator is contained in a separate manual that
accompanies the Generator (RFP-100A 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.
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 and use of diagnostic medical
equipment in a fully equipped catheterization laboratory.

Visually inspect the DuoMode Cable to ensure there is no degradation, such as
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.
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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
EU Authorized Representative:
Quality First International
20 Eversley Road, Bexhill-on-Sea, East Sussex
TN40 1HE, United Kingdom
Tel: +44-(20)-8-522-1937 Fax: +44-(20)-8-522-1937
and/or issued.
devices, the Baylis Medical
Therefore, adequate

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 grounded 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
Generator Connector
Generator Connector Cable Colour
Diagnostic Equipment Connector
Diagnostic Equipment Cable Colour
Puncture Device Connector Port
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
Have you done
a visual check
Visual Check
on the entire
system?
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.
Company
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.
Diagnostic
Equipment
Connector
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 key features
of the connector and 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. 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.
DMR RFX-BAY-DUO 3.3 (RFX-BAY-DUO-100A) V-2 07-Mar-2018
RFX-BAY-DUO-100A
4-pin (Plug)
Black
Touchproof 2mm Connector (DIN 42802)
Red
4-pin (receptacle)
QUESTION? WARNINGS AND EXPLANATIONS
Ensure connectors and the cable have no visible
damage, such as discoloration, cracks, label fading,
cable splice, or kinks. Do not use damaged
equipment.
Generator
Connector
Puncture
Device
Connector
Port