Baylis Medical RFP-100A Manuel D'instructions

Instructions for Use
Reusable RFP-100A
Connector 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 OÜ
Laki 30, 12915 Tallinn
Estonia
Telephone: +372 610 41 96
Email: enquiries@qualityfirstint.ee
EU Importer:
MedEnvoy
Prinses Margrietplantsoen 33 – Suite 123
2595 AM The Hague
The Netherlands
© Copyright Baylis Medical Company Inc., 2009-2021
Baylis Medical logo is a trademark and/or registered trademark 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.
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 RFP-100A connector cable connects the Baylis Medical Company
RFP-100A Radiofrequency Puncture Generator (RFP-100A Generator) to Baylis
Medical approved radiofrequency puncture devices.
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 RF puncture
devices is contained in separate manuals that accompany these devices.
The dimensions for the Reusable RFP-100A connector cable can be found on the
device label and in section VII "Product Specifications." The Reusable RFP-100A
connector cable 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 Reusable RFP-100A connector cable is to connect the
RFP-100A Generator to Baylis Medical approved puncture devices (RF puncture
devices).
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III.
The Reusable RFP-100A connector cable is not recommended for use with any
other RF generator or any other device.
IV.
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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 associated with the use of this device are similar to those indicated
for the Baylis Medical Radiofrequency Puncture System.
VII.
VIII.
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.
This Cable enables
IX.
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.
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
CONTRAINDICATIONS
WARNINGS
The Reusable RFP-100A connector cable is a reusable device. Only use
the validated cleaning and sterilization methods as described in section XI
"Cleaning and Sterilization Instructions" to clean and sterilize the Connector
Cable. No other cleaning and sterilization methods have been tested.
Failure to properly clean and sterilize the device can cause patient injury
and/or the communication of infectious disease(s) from one patient to
another.
The Reusable RFP-100A connector cable must only be used with the RFP-
100A Generator 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.
PRECAUTIONS
Do not attempt to use the Reusable RFP-100A connector 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 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 Reusable RFP-100A connector cable is intended for use with RF
puncture devices only.
Never disconnect the Reusable RFP-100A connector cable from the RFP-
100A Generator while the Generator is delivering RF power.
Never disconnect the Reusable RFP-100A connector cable 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 Reusable RFP-100A connector 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 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.
ADVERSE EVENTS
PRODUCT SPECIFICATIONS
Model Number RFX-BAY-TS
Strain Relief Colour Black at device end, blue at generator end
Overall Useable Length 10 feet (3m)
Generator Connector 4-pin (Plug)
Device Connector 4-pin (receptacle)
INSPECTION PRIOR TO USE
KEY ITEMS QUESTION?
The Reusable RFP-100A connector cable is supplied
Is the sterile for its initial use. Inspect the packaging to
Sterility connector ensure the package has not been damaged and
cable sterile? sterility has not been compromised. Prior to each
subsequent use it must be cleaned and sterilized.
Have you
Ensure connectors and the cable have no visible
done a visual
damage, such as discoloration, cracks, label fading,
Visual Check check on the
cable splice, or kinks. Do not use damaged
entire
equipment.
system?
EQUIPMENT REQUIRED
DIRECTIONS FOR USE
DMR RFX 3.3 V-11 16-Jul-2021
WARNINGS AND EXPLANATIONS