Baylis Medical RFP-100A User manual

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BAYLIS MEDICAL COMPANY INC.
BMC RADIOFREQUENCY PUNCTURE
GENERATOR
© Copyright Baylis Medical Company Inc., 2001-2012
PowerWire
TM
, NRG
TM
and The Baylis Medical Company logo are trademarks and/or registered trademarks of Baylis
Medical Company Inc. in the United States of America and/or other countries.
EN
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.

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BAYLIS MEDICAL COMPANY INC.
BMC RADIOFREQUENCY PUNCTURE
GENERATOR
Instructions for Use
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.
Manufacturer:
Baylis Medical Company Inc
5959 Trans-Canada Highway
Montreal, Quebec
Canada
H4T 1A1
Phone: [phone]
Fax: [phone]
EU Authorized
Representative:
Quality First International
20 Eversley Road
Bexhill-on-Sea
East Sussex
TN40 1HE
United Kingdom
Phone: [phone]
Fax: [phone]
0120

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TABLE OF CONTENTS
TABLE OF CONTENTS ................................................................................................. 3
LIST OF FIGURES .......................................................................................................... 5
LIST OF TABLES ............................................................................................................ 5
PREFACE.......................................................................................................................... 6
SECTION 1: DEVICE DESCRIPTION .................................................................... 7
SECTION 2: INDICATIONS/CONTRAINDICATIONS........................................ 8
2.1. INDICATIONS FOR USE.......................................................................................................... 8
2.2. CONTRAINDICATIONS........................................................................................................... 8
SECTION 3: WARNINGS, PRECAUTIONS, AND ADVERSE EVENTS ........... 9
3.1. WARNINGS ............................................................................................................................... 9
3.2. PRECAUTIONS ........................................................................................................................10
3.3. ADVERSE EFFECTS................................................................................................................11
SECTION 4: UNPACKAGING AND REPACKAGING....................................... 12
4.1. UNPACKAGING.......................................................................................................................12
4.2. REPACKAGING .......................................................................................................................12
SECTION 5: CONTROLS AND DISPLAYS.......................................................... 13
5.1. GENERATOR SOFTWARE FLOW CHART...........................................................................15
5.2. RF ON/OFF BUTTON/LIGHT..................................................................................................16
5.3. POWER......................................................................................................................................17
5.4. TIME ..........................................................................................................................................18
5.5. IMPEDANCE DISPLAY...........................................................................................................19
5.6. SET INDICATOR......................................................................................................................19
5.7. MEASURED INDICATOR .......................................................................................................19
5.8. FAULT INDICATOR ................................................................................................................20
5.9. POWER SWITCH......................................................................................................................20
5.10. VOLTAGE SELECTOR SWITCH............................................................................................20
5.11. FOOTSWITCH ..........................................................................................................................20
SECTION 6: PORTS/CONNECTORS.................................................................... 22
6.1. ISOLATED PATIENT CONNECTIONS..................................................................................22
6.2. FOOTSWITCH CONNECTOR.................................................................................................22
6.3. POWER CONNECTOR.............................................................................................................22
6.4. SERIAL PORT...........................................................................................................................22
6.5. EQUIPOTENTIAL GROUND CONNECTION:.......................................................................23
SECTION 7: DIRECTIONS FOR USE................................................................... 24
7.1. READ INSTRUCTIONS FOR USE ..........................................................................................24
7.2. VERIFY VOLTAGE SELECTOR SETTING ...........................................................................24
7.3. CONNECT GENERATOR POWER CORD .............................................................................24
7.4. CONNECT BMC RFP CONNECTOR CABLE........................................................................24
7.5. CONNECT THE DIP ELECTRODE.........................................................................................25
7.6. TURN THE GENERATOR “ON”.............................................................................................25

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7.7. SELECT POWER LEVEL.........................................................................................................26
7.8. SET TIME DURATION ............................................................................................................26
7.9. CONFIRM GENERATOR AND ACCESSORY SETTINGS AND STATE ............................26
7.10. RF POWER DELIVERY ...........................................................................................................26
7.11. TURNING RF POWER “OFF” .................................................................................................27
7.12. RE-APPLY RF POWER ............................................................................................................27
SECTION 8: SERVICE AND MAINTENANCE ................................................... 28
8.1. CLEANING ...............................................................................................................................28
8.2. FUSE REPLACEMENT ............................................................................................................28
SECTION 9: SPECIFICATIONS............................................................................. 29
9.1. GENERAL SPECIFICATIONS.................................................................................................29
9.2. POWER DELIVERY .................................................................................................................31
9.3. OUTPUT POWER GRAPHS.....................................................................................................32
9.4. ERROR CODES.........................................................................................................................34
9.5. IEC ELECTRICAL SAFETY AND EMC SPECIFICATIONS ................................................35
9.6. LABELING AND SYMBOLS...................................................................................................39
SECTION 10: LIMITED WARRANTIES AND DISCLAIMER........................ 41

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LIST OF FIGURES
Page
Figure 5-1 Generator Front Panel .................................................................................... 13
Figure 5-2 Generator Back Panel..................................................................................... 14
Figure 5-3 - Software Flow Chart..................................................................................... 15
Figure 9-1 Power vs Load at 25W Setting....................................................................... 32
Figure 9-2 Power vs Load at 12W Setting....................................................................... 32
Figure 9-3 Peak Voltage vs Power Setting ...................................................................... 33
Figure 9-4 Power Output vs Power Setting ...................................................................... 33
LIST OF TABLES
Page
Table 9.5-1 IEC Electrical Safety Specifications ............................................................. 35
Table 9.5-2 IEC EMC Specifications (Emissions) ........................................................... 35
Table 9.5-3 IEC EMC Specifications (Immunity)............................................................ 36
Table 9.5-4 IEC Recommended Separation of RF Communication Equipment .............. 38

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PREFACE
For the user’s convenience, the BMC Radiofrequency Puncture Generator will be
referred to in this Operator’s Manual as the “Generator”. The Generator may be used
with active electrodes that have been separately cleared for use with the Generator.
These separately cleared active electrode devices include, but are not limited to, the
Nykanen Radiofrequency Wire, the PowerWireTM Radiofrequency Guidewire, the
Toronto Transseptal Catheter,and the NRGTM Transseptal Needle - they will generally be
referred to in this Operator’s Manual as the “Catheter”. The catheter is connected to the
Generator through the appropriate BMC connector cable. The footswitch is an accessory
to the BMC Radiofrequency Puncture Generator.
The use of the Baylis Medical Radiofrequency Puncture Generator is fully described in
this manual, including a description of the Generator, its controls, displays, and a
sequence for its operation. In addition, other information of importance to the user is
supplied. For specific instructions pertaining to the use of any one of the separately
cleared catheters, please refer to the instructions for use for the respective catheters.
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a
physician.

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SECTION 1: DEVICE DESCRIPTION
The Baylis Medical Company Radiofrequency Puncture Generator is a component of the
Baylis Medical Company Radiofrequency Puncture System. The Generator is operated in
conjunction with a BMC Catheter and a commercially available external Disposable
Indifferent (Dispersive) Patch (DIP) Electrode that meets or exceeds ANSI/AAMI
Standard HF-18 and/or ISO 60601-2-2. The BMC Catheter delivers power in a
monopolar mode between its distal tip electrode and the indifferent patch electrode.
Detailed information regarding the Catheter is contained in a separate manual that
accompanies each Catheter.
The Generator produces continuous radiofrequency (RF) power output at a fixed
frequency in the range of 455 kHz to 465 kHz in a monopolar mode. Connections for the
Catheter and a patient return electrode are provided. Controls on the front panel allow
the power level and the duration of the RF output to be set. In addition, controls on the
front panel provide on/off control of the output. Measured values for output power,
impedance, and elapsed time are displayed during RF output whilst a constant audible
tone is also produced. The Generator has several built-in safety features, such as warning
messages, an automatic shutoff (if the measured impedance falls below 100 ohms or
exceeds 6000 ohms), and maximum voltage and current limits.

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SECTION 2: INDICATIONS/CONTRAINDICATIONS
2.1. INDICATIONS FOR USE
The Baylis Medical Radiofrequency Puncture System is intended to create an
atrial septal defect in the heart.
2.2. CONTRAINDICATIONS
Usage of the Radiofrequency System is not recommended for usage other than the
indicated use.

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SECTION 3: WARNINGS, PRECAUTIONS, AND ADVERSE EVENTS
3.1. WARNINGS
•DO NOT attempt to operate the Generator before thoroughly reading this User’s
Manual. It is vital that the operating instructions for the equipment be read,
understood, and followed properly. For future reference, retain this User’s
Manual in a convenient, readily accessible place.
•The Generator is intended for use with approved Catheters and accessories only.
•Do not remove the cover of the Generator. Removal of the cover may result in
injury and/or damage to the Generator.
•When the Generator is activated, conducted and radiated electrical fields may
interfere with other medical equipment. Care should be taken to limit the effects
that electromagnetic interference (EMI) produced by the Generator has on other
equipment.
•Laboratory staff and patients can undergo significant x-ray exposure during RF
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.
•Do not attempt to puncture with an initial power setting greater than that
recommended by the Catheter Instructions For Use. The output power selected
should be as low as possible for the intended purpose.
•Failure of the Generator could result in an unintended increase of output power.
•Place monitoring electrodes as far away from the surgical site as possible, to
avoid burns or interference with other equipment. The use of needle monitoring
electrodes (or other small area electrodes) during RF output is not recommended.
In all cases, monitoring systems incorporating high frequency current limiting
devices are recommended.
•Skin-to-skin contact (for example between the arms and body of the patient)
should be avoided, for example by insertion of dry gauze).
•The Generator is not equipped with a Contact Quality Monitor, thus loss of safe
contact between the dispersive and the patient will not result in an auditory alarm.
•During RF output, implated devices such as pacemakers may be affected.
Qualified advice should be obtained as necessary, to minimize the risk from
injury to due implanted device malfunction.

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3.2. PRECAUTIONS
•The Generator is intended for use with approved Catheters, Wires and accessories
only. Ensure that the rated accessory voltage is equal to or greater than the
Generator’s maximum output voltage.
•Ensure that the catheter connector cables and dispersive electrode cables are
positioned in such a way that contact with the patient or other leads is avoided.
•It is recommended not to exceed the specified number of power applications per
Catheter, as indicated within the Catheter’s specific instructions for use.
•Do not attempt to use the Generator before thoroughly reading the Generator
User’s Manual.
•Only physicians thoroughly trained in RF Puncture techniques, in a fully equipped
catheterization laboratory, should perform RF Puncture procedures.
•Adequate filtering must be used to allow continuous monitoring of the surface
electrocardiogram (ECG) during RF power applications.
•Read and follow the manufacturer’s instructions for use of the Disposable
Indifferent (Dispersive) Patch (DIP) electrode. Always use dispersive electrodes
that meet or exceed IEC 60601-2-2 requirements. The entire area of the dispersive
electrode should be reliably attached to the patient’s body and as close to the
operating field as possible.
•Placement of the dispersive electrode on the thigh could be associated with higher
impedance.
•The Generator is capable of delivering significant electrical power. Patient or
operator injury can result from improper handling of the Catheter and dispersive
electrode, particularly when operating the device.
•During power delivery, the patient should not be allowed to come in contact with
grounded metal surfaces or metal surfaces which have an appreciable capacitance
to earth (for example operating table supports, etc). The use of antistatic sheeting
is recommended for this purpose.
•Apparent low power output or failure of the equipment to function properly at
normal settings may indicate faulty application of the dispersive electrode or
failure of an electrical lead. Do not increase power before checking for obvious
defects or misapplication.

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•In order to prevent the risk of ignition make sure that flammable material is not
present in the room during RF power application.
•Take precautions to limit the effects that the electromagnetic interference (EMI)
produced by the Generator may have on the performance of other equipment.
•Regularly inspect and test re-usable cables and accessories.
•Baylis Medical Company relies on the physician to determine, assess, and
communicate to each individual patient all foreseeable risks of the Generator.
•The mains power cord of the Generator must be connected to a properly grounded
receptacle. Extension cords and/or adapter plugs must not be used.
3.3. ADVERSE EFFECTS
Adverse events that may occur while using the Baylis Medical Radiofrequency Puncture
System include:
•Atrial Fibrillation and/or Atrial Flutter
•Myocardial Infarction
•Sustained arrhythmias leading to Ventricular Tachycardia.

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SECTION 4: UNPACKAGING AND REPACKAGING
4.1. UNPACKAGING
The Generator’s shipping carton contains all of the components identified below.
Unpack the Generator and accessories carefully and visually inspect for damage. Notify
the carrier immediately if the shipment carton is damaged. Verify that the following
items are received:
1 Generator
1 Operator’s Manual
1 Power Cord
Read the Directions for use in Section 7 of this manual very carefully and thoroughly. If
there are any discrepancies or concerns, notify Baylis Medical Company. Store the
shipping carton in a safe place for future use.
4.2. REPACKAGING
If it is necessary to repack and ship the Generator, use the original shipping carton and
packing materials to ensure that no breakage occurs. Disconnect all the cables and
accessories and place them into the locations in the carton that are reserved for these
units. Do not attempt to forcefully fit all the components in the carton.

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SECTION 5: CONTROLS AND DISPLAYS
The generator has controls and displays on both its front and rear panels as shown in
Figures 5-1 and 5-2, respectively. Related controls and displays are grouped into distinct
areas and are discussed below.
Figure 5-1 Generator Front Panel
A B C
D E F
G
H IJ K M NL

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Figure 5-2 Generator Back Panel
A B
C D
E
F

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5.1. GENERATOR SOFTWARE FLOW CHART
Figure 5-3 - Software Flow Chart
Generator
Off
Generator turned on
POST Mode
•Self diagnostics
Failed test
READY Mode
•SET indicator lit
•Time can be
adjusted
•Power can be
adjusted
Generator passes
self-tests
ON Mode
•Energy is delivered
•RF ON/OFF
BUTTON/LIGHT lit
•TIME display counts up
from 0 seconds
•Power display indicates
measured applied power
•Impedance display shows
measured Impedance
•Self test
FAIL Mode
•Fault indicator lit
•Impedance
display flashes
error code
•Contact Baylis
Medical Company
Non-recoverable
fault
Either
•RF ON button pressed
•TIME expired
•Footswitch released
•Recoverable Fault
DONE Mode (5 seconds)
•RF delivery is ceased
•TIME displays duration
energy was applied
•POWER displays last
measured power delivery
After 5
seconds in
DONE
mode
Either
•RF ON/OFF button pressed
•Footswitch depressed

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FRONT PANEL
5.2. RF ON/OFF BUTTON/LIGHT
The RF ON/OFF Button/Light is shown in Figure 5-1G. This button is
responsible for the three operational modes of the Generator: “READY”, “ON”,
and “DONE”. A relationship of the modes and the events required to select each
mode is provided in section 5.1
In the “READY” mode the power level and the count-up timer can be set, the
impedance display is blank, the RF ON/OFF Button is not illuminated, and the
audible tone is off.
In the “ON” mode, which is initiated when the RF ON/OFF Button is pressed, RF
output is active, RF ON/OFF Button/Light is illuminated green, timer display
counts up from 0 seconds to the set time, the audible tone is ON, and the actual
power and impedance are displayed. The RF output is terminated and the mode
changes to DONE (or FAULT) mode when the timer elapses, when the RF
ON/OFF Button is depressed during ON mode, or when an error is detected.
In the DONE mode, the RF output is OFF, the RF ON/OFF Button is not
illuminated, and the audible tone is off. The Generator passes through the DONE
mode as a transition from the ON mode back to the READY mode. The DONE
mode lasts for five seconds and then automatically changes to the READY mode.
The last measured Power, Impedance, and Timer Displays are held during the
DONE mode. The last two seconds of the DONE mode will display an error code
if termination was due to an error.
Note: Two other modes that the Generator has are the POST mode and the FAULT
mode.
The Generator enters into the POST mode when it is first turned on. In the POST mode
the Generator performs a self-test of power generation, measurement, and control
circuitry. The Generator either transitions to the READY mode upon successful
completion of a self-test or transitions to the FAULT mode if the self-test fails.
The Generator enters into the FAULT mode when a non-recoverable error is detected, at
which point the FAULT light (Fig. 5-1H) is illuminated and a rapid burst of audible tones
is produced.

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5.3. POWER
•POWER DISPLAY
The POWER Display is shown in Figure 5-1A. The power output is displayed in
1-Watt increments and the range is 0-25 Watts. The POWER Display is a two
digit, green LED numeric display. When the generator is initially powered “ON”,
the green LEDs will display the default power set point of 0 Watts. The desired
power output can be set using the POWER ▲/▼Buttons (Fig. 5-1B/5-1C). The
POWER Display shows the set power (1-25 Watts) during the READY mode and
then displays the measured delivered power (0-25 Watts) during ON mode. The
measured power may be lower than the set power, depending on tissue
impedance. The POWER Display will show the last measured power (0-25
Watts) during the DONE mode for five seconds while the generator completes the
DONE mode and transitions to the READY mode. When the generator enters
READY mode, the prior preset power level will be displayed, which can be
adjusted as desired.
•POWER ▲/▼BUTTONS
The POWER ▲/▼Buttons are shown in Fig. 5-1B/5-1C. By pressing the
POWER ▲/▼Buttons you can set the level of power you want the generator to
deliver to the Catheter during the Puncture process. By pressing the button once,
you increase/decrease the power setting by 1 Watt. If you continue to hold down
the button, you will see the power level scroll up/down rapidly. Once the button
is released, the scrolling will stop. The POWER Display (Fig. 5-1A) shows the
maximum amount of power the generator will deliver to the Catheter. The range
for the POWER is 1-25 Watts in increments of 1 Watt.
Note: During the process of application of energy, the POWER ▲/▼Buttons can be
pressed to increase/decrease the level of power delivered by 1-Watt increments. The
POWER Display will show the actual power delivered during the application of
radiofrequency energy. The scrolling function of the POWER ▲/ ▼Button will not
work during the delivery of RF power (RF Power “ON” mode).

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5.4. TIME
•TIME DISPLAY
The TIME Display is shown in Figure 5-1E. This display is a two-digit, green
LED numeric display. The TIME Display will read zero when the Generator is
initially powered “ON”. The desired output duration expressed in seconds can be
set by the TIME ▲/▼Buttons (Fig. 5-1D/5-1F), during the READY mode. The
count-up time duration (0-99 seconds) is shown during the ON mode, as RF
energy is delivered. If RF power delivery is stopped before the preset duration
has been reached, the actual duration of RF power delivery will be displayed for
five seconds while the generator reaches the DONE mode and transitions to the
READY mode. Once in READY mode, the prior preset time duration will be
displayed and can be adjusted as desired.
•TIME ▲/▼BUTTONS
The TIME ▲/▼Buttons are shown in Figure 5-1D/5-1F. Pressing the ▲/▼
buttons increase/decrease the duration that RF energy will be delivered. By
pressing the button once, you can increase the maximum duration by incremental
steps of 1 second. By continuously holding down the button, you will see the
numerical display scroll rapidly.
Note: The TIME ▲/▼Buttons are NOT functional during the RF Power “ON” mode
(when RF power is being delivered).

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5.5. IMPEDANCE DISPLAY
The IMPEDANCE Display is shown in Figure 5-1K. The IMPEDANCE Display
is a four-digit, green LED numeric display. The impedance measurement range is
100-6000 ohms. The displayed value will fluctuate during impedance
measurement since it is a measure of catheter-to-tissue contact. During the
READY mode, the IMPEDANCE Display remains blank since impedance is only
measured during the ON mode while RF output is active. When RF power is
discontinued (DONE mode) the last measured value of the impedance will remain
on the display for five seconds while the generator completes the DONE mode
and transitions to the READY mode. Once in the READY mode, the Impedance
Display becomes blank.
Note: If the impedance exceeds 6000 ohms, the Generator will automatically cease the
delivery of RF power and the IMPEDANCE Display will show a flashing “E002” error
message to alert the user to the high impedance value. This error message will also be
seen if the user attempts to deliver RF power to the Catheter when there is an electrical
open circuit. The open circuit may be caused by various influences, such as a Catheter
that was not connected to the BMC Connector Cable. If the impedance drops below 100
ohms, the Generator will automatically cease the delivery of RF power and the display
will show a flashing “E001” error message to alert the user to the low impedance value.
5.6. SET INDICATOR
The SET Indicator is shown in Figure 5-1M. It is a yellow LED that is
illuminated during the READY mode. When the generator is in the READY
mode, the timer and power levels can be set.
5.7. MEASURED INDICATOR
The MEASURED Indicator is shown in Figure 5-1N. It is a green LED that is
illuminated when the Generator is in the ON mode. The Measured Indicator
switches off after the Generator transitions from the DONE mode to the READY
mode, but stays lit during the DONE mode.

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5.8. FAULT INDICATOR
The FAULT Indicator is shown in Figure 5-1H. It is a red LED that indicates that
a system error has occurred. The error code is displayed on the IMPEDANCE
Display (Fig. 5-1K). There are three categories of error codes: error(s) during the
POST mode, error(s) during the ON mode, and error(s) in the CPU Hardware
self-test. Recoverable errors do not cause the Fault Indicator to illuminate, but
instead cause a transition to the DONE mode. Non-recoverable errors cause a
transition to the FAULT mode and illuminate the LED. To interpret the error
codes, refer to the table entitled “Summary of Error Conditions and Error Codes”
in Section 9.4. RF power is disabled when the FAULT Indicator is illuminated.
5.9. POWER SWITCH
The POWER Switch is shown in Figure 5-2A. Turn the Generator “ON” by
pressing the rocker switch to the “I” position. Pressing the rocker switch to the
“0” position will power the Generator “OFF”.
5.10. VOLTAGE SELECTOR SWITCH
The orientation of this switch (Figure 5-2D), in conjunction with the Fuse Drawer
(Figure 5-2E), determines the AC input voltage range (100-120V~ or 220-
240V~).
Note: The voltage selector and the orientation of the Fuse Drawer must be set to the
same voltage setting. Do not change the position of the voltage selector while the system
is plugged in.
5.11. FOOTSWITCH
The pneumatic footswitch can be used as an alternative to the RF ON/OFF button
described in section 5.2. As an alternative, it is also responsible for the three
operational modes of the Generator: “READY”, “ON”, and “DONE”. A
relationship of the modes and the events required to select each mode is provided
in section 5.1. Footswitch operation is abbreviated on the label “Generator
Operation” found on the top of the generator and described below.
In the “READY” mode the power level and the count-up timer can be set, the
impedance display is blank, the RF ON/OFF Button is not illuminated, and the
audible tone is off.
In the “ON” mode, which is initiated when the footswitch is pressed and held, RF
output is active, RF ON/OFF Button/Light is illuminated green, timer display
counts up from 0 seconds to the set time, the audible tone is ON, and the actual
power and impedance are displayed. The RF output is terminated and the mode
changes to DONE (or FAULT) mode when the timer elapses, when the footswitch