Baylis Medical RFX-BAY-OTW-12-SU Instructions For Use Manual

Instructions for Use
RFP-100A Connector Cable
(Single Use)
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
© Copyright Baylis Medical Company Inc., 2010-2018.
Baylis Medical Company logo
is a registered trademark of Baylis Medical Company Inc.
in the United States of America and/or other countries.
v
English_________ _____
Carefully read all instructions prior to use.
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 RFP-100A Connector Cable (Single Use) connects the Baylis Medical Company RFP-100A
Radiofrequency Puncture Generator (RFP-100A Generator) to Baylis Medical approved
radiofrequency puncture devices. This Cable enables radiofrequency (RF) power to be delivered
from the Generator to the puncture device.
Detailed information concerning the RFP-100A Generator is contained in a separate manual that
accompanies the Generator (RFP-100A Generator Instructions for Use). In addition, detailed
information concerning the separately cleared compatible RF devices is contained in separate
manuals that accompany these devices.
The dimensions for the RFP-100A Connector Cable (Single Use) can be found on the device
label and in section VII "Product Specifications." The RFP-100A Connector Cable (Single Use)
has a four-pin connector on one end that mates with the RFP-100A Generator and a connector
at the other end, which mates with the puncture device.
II. INDICATIONS FOR USE
The intended use of the RFP-100A Connector Cable (Single Use) is to connect the RFP-100A
Generator to separately cleared compatible RF devices.
III. CONTRAINDICATIONS
The RFP-100A Connector Cable (Single Use) is not recommended for use with any other RF
generator or any other device.
IV. WARNINGS

The RFP-100A Connector Cable (Single Use) is a single use device. It should not be
cleaned, re-sterilized or re-used. Reuse can cause the patient injury and/or the
communication of infectious disease(s) from one patient to another.

The RFP-100A Connector Cable (Single Use) must only be used with the RFP-100A
Generator and separately cleared compatible RF 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 RFP-100A Connector Cable (Single Use) 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 radiofrequency powered puncture in a fully equipped catheterization
laboratory.

The sterile packaging should be visually inspected prior to use to detect any compromise.
Ensure that the packaging has not been damaged. Do not use the equipment if the
packaging has been compromised.

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 RFP-100A Connector Cable (Single Use) is intended for use with separately cleared
compatible RF devices only.

Never disconnect the RFP-100A Connector Cable (Single Use) from the RFP-100A
Generator while the Generator is delivering RF power.

Never disconnect the RFP-100A Connector Cable (Single Use) from the RFP-100A
Generator by pulling on the cable. Failure to disconnect the cable properly may result in
damage to the cable.

Do not twist the RFP-100A Connector Cable (Single Use) while inserting or removing it
from the Isolated Patient Connector on the Generator. Twisting the cable may result in
damage to the pin connectors.
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Observe all contraindications, warnings and

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.
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 radiofrequency 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 RFP-100A BMC Radiofrequency Puncture
Generator, connector cables and separately cleared compatible RF devices.
VI. ADVERSE EVENTS
Adverse events associated with the use of this device are similar to those indicated for the RFP-
100A BMC Radiofrequency Puncture Generator and separately cleared compatible RF devices.
VII. PRODUCT SPECIFICATIONS
Model Number RFX-BAY-OTW-10-SU
RFX-BAY-OTW-12-SU
RFX-STX-OTW-14-SU
Overall Useable Length 10 feet (3m)
Generator Connector
4-pin
Device Connector Push button
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 WARNINGS AND EXPLANATIONS
Prior to using the RFP-100A Connector Cable (Single Use) inspect
Sterility the packaging to ensure the package has not been damaged and
sterility has not been compromised.
Ensure connectors and the cable has no visible damage, such as
Visual Check
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 RFP-100A Generator Instructions for Use), the
RFP-100A Connector Cable (Single Use) 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.
Connector Cable (Single Use) 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. Firmly grasp the catheter connector end of the cable in one hand. Using your thumb depress
the red button on the top of the connector. Slowly insert the proximal end of the RF puncture
wire into the opening of the catheter connector. Once the exposed portion of the proximal
end of the device is no longer visible release the red button on the connector. Gently tug on
the device to ensure that you have a secure connection.
4. To disconnect the puncture device from the Connector Cable, depress the red button on the
catheter connector and gently remove the proximal end of the puncture device from the
connector cable.
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
The RFP-100A Connector Cable (Single Use) is a single use device supplied sterile and should
not be re-sterilized or reused. The RFP-100A Connector Cable (Single Use) 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.
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
XII. TROUBLESHOOTING
The following table is provided to assist the user in diagnosing potential problems.
PROBLEM COMMENTS
Generator In order to successfully
Alert/Error puncture tissue using
Messages
radiofrequency energy, the
entire system must be
connected and all devices
must be in good working
order.
Check the
RFX-BAY-TS-12-SU
10 feet (3m)
4-pin
1-pin connector
The RFP-100A
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
DMR RFX-SU 3.3 V-11 08-Mar-2018