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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 Baylis Medical Connector Cable connects the BMC Radiofrequency Puncture Generator to Baylis
Medical Radiofrequency Puncture Catheters and Wires. This Cable enables radiofrequency (RF)
power to be delivered from the Generator to the puncture device.
Detailed information concerning the Baylis Medical Radiofrequency Puncture Generator is contained
in a separate manual that accompanies the Generator (entitled "BMC Radiofrequency Puncture
Generator Instructions for Use"). In addition, detailed information concerning the radiofrequency
puncture catheters and wires is contained in separate manuals that accompany these devices.
The dimensions for the Connector Cable can be found on the device label and in section VII "Product
Specifications." The Connector Cable has a four-pin connector on one end that mates with the
Generator and a connector at the other end, which mates with the puncture device.
II.
INDICATIONS FOR USE
The intended use of the BMC Connector Cable is to connect the BMC RF Puncture Generator to
Baylis Medical puncture catheters.
III.
CONTRAINDICATIONS
The BMC Connector Cable is not recommended for use with any other RF generator or any other
catheter/wire.
IV.
WARNINGS
•
The 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 Connector Cable must only be used with the BMC RF Puncture Generator and Baylis
Medical RF puncture devices. Attempts to use it with other RF Generators and catheters or
wires 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 BMC 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 BMC Connector Cable is intended for use with BMC RF Puncture devices only.
•
Never disconnect the BMC Connector Cable from the BMC RF Puncture Generator while the
Generator is delivering RF power.
•
Never disconnect the BMC Connector Cable from the BMC RF Puncture Generator by pulling
on the cable. Failure to disconnect the cable properly may result in damage to the cable.
•
Do not twist the Connector Cable while inserting or removing it from the Catheter 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.
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
RFP-101
Overall Useable Length
10 feet
Generator Connector
4-pin
Wire/Catheter 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
QUESTION?
Is the connector cable
Sterility
sterile?
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.
X.
DIRECTIONS FOR USE
Once the Baylis Medical RF puncture device is properly positioned at the puncture site, and the
Generator is properly set up (following the instructions in the BMC Radiofrequency Puncture
Generator Instructions for Use), the BMC Connector Cable can be used to connect the catheter or
wire to the Generator.
1.
Connect the generator connector end of the cable to the appropriate port on the BMC RF
Puncture Generator as per the Generator Instructions for Use. The Connector Cable uses a
circular connector, keyed for proper alignment. Gently line up the connector pins with the
Page 2 of 13
RFP-102
RFP-103
10 feet
10 feet
4-pin
4-pin (plug)
4-pin
Single Socket
(receptacle)
WARNINGS AND EXPLANATIONS
The BMC Connector Cable is supplied
sterile for its initial use.
Prior to each
subsequent use it must be cleaned and
sterilized.
Ensure connectors and the cable have
no visible damage, such as discoloration,
cracks, label fading, cable splice, or
kinks. Do not use damaged equipment.
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.
Secure the screw-on locking ring mechanism of the generator connector to the appropriate port
on the BMC RF Puncture Generator as per the Generator Instructions for Use to complete the
connection.
4.
Firmly grasp the catheter connector end of the cable in one hand:
a)
For model RFP-101: Using your thumb depress the red button on the top of the
connector. Slowly insert the proximal end of the Baylis Medical RF puncture
device 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.
b)
For model RFP-102: Slowly insert the proximal end connector of the Baylis
Medical RF puncture device into the opening of the catheter connector until the
two connectors are fully mated.
c)
For model RFP-103: Gently line up the spcket pins with the connector and push
in until the connector fits firmly into the socket.
5.
The Puncture System is now ready to deliver RF power to the puncture site.
6.
To disconnect the puncture device from the Connector Cable:
a)
For model RFP-101: Depress the red button on the catheter connector and
gently remove the proximal end of the puncture device from the connector cable.
b)
For model RFP-102: Firmly grasp the plug of the catheter connector end of the
cable in one hand and gently pull on the puncture device.
c)
For model RFP-103: Firmly grasp the receptacle end of the cable in one hand
and gently pull it straight out of the connector on the puncture device.
7.
To disconnect the cable from the generator, rotate the locking ring of the generator connector
counter clockwise to unlock, then grasp the connector firmly and gently pull it straight out of the
socket.
XI.
CLEANING AND STERILIZATION INSTRUCTIONS
DANGER
The BMC Connector Cable is supplied sterile, however it must be cleaned and sterilized before each
subsequent use as described in this Instructions for Use document. Failure to properly clean and
sterilize the device can cause patient injury and/or the communication of infectious diseases from one
patient to another.
IMPORTANT
The manufacturer recommends the user follow a quality control program for each sterilization cycle
that meets or exceeds American Operating Room Nurses (AORN) Standards, Recommended
Practices & Guidelines - 2000. This program includes, but is not limited to recording:
•
Type of sterilizer and cycle used
•
Lot control number
•
Load contents
•
Exposure time and temperature, if not provided by a recording chart
•
Operator's name
•
Results of sterilization process monitoring (i.e. chemical, mechanical, biological)
Cleaning and Decontamination
1.
Ensure that blood and other contaminates do not dry on the BMC Connector Cable.
2.
Visually inspect the cable for defect.
3.
Rinse the cable with de-ionized water until colourless run-off water occurs. Once the water
runs clear, soak the cable (except for the connectors at the ends of the cable) in de-ionized
water at 22°C-48°C for 1 minute. Remove the cable from the water and scrub it with a soft
bristle brush until it is visually clean. Note: Do not let the connectors soak. Wipe them as
necessary until they are visually clean.
4.
Soak the cable (except for the connectors) in an enzymatic cleaning solution (such as Terg-A-
ZymeÒ) for 20 minutes. Ensure that the temperature of the solution is below 55°C. Scrub
again with a soft bristle brush, and rinse thoroughly using de-ionized water until all traces of
detergent residue are removed.
5.
Visually inspect the parts for debris. If any is present repeat steps 2 and 3.
6.
Dry the cable with a clean, dry, lint free towel.
7.
Place the cable on a sterilization tray.
Sterilization
For a prevacuum sterilizer:
WRAPPED:
132°C-135°C (270°F-275°F) FOR 3-4 MIN.
UNWRAPPED: "FLASH' STERILIZATION 132°C FOR 4 MIN.
NOTE:
Only the above cleaning and sterilization methods have been validated for the BMC Connector Cable.
No other cleaning and sterilization methods have been tested. Failure to follow these instructions can
cause patient injury and/or the communication of infectious disease(s) from one patient to another.
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
Generator Error
In order to successfully
Messages
puncture tissue using
radiofrequency energy, the
entire system must be
connected and all devices
must be in good working
order.
DMR RFP Cables 3.3 V-14.01 03-Apr-2020
COMMENTS
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 messages
encountered while attempting
puncture, refer to the
operator's manual that
accompanies the Generator.
If errors persist, attach a new
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