Baylis RFP-100A User manual

© 2012-2019 Baylis Medical Company Inc. 1 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
BAYLIS MEDICAL COMPANY RADIOFREQUENCY
PUNCTURE GENERATOR
RFP-100A
ENGLISH
User’s Manual
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]
PowerWire,NRG, VersaCross, DuoModeand 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 and/or issued.
1639

© 2012-2019 Baylis Medical Company Inc. 2 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx

© 2012-2019 Baylis Medical Company Inc. 3 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
This page is intentionally left blank

© 2012-2019 Baylis Medical Company Inc. 4 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
TABLE OF CONTENTS
LIST OF FIGURES...................................................................................................................... 6
LIST OF TABLES........................................................................................................................ 6
PREFACE 7
SECTION 1: DEVICE DESCRIPTION................................................................................. 8
SECTION 2: INDICATIONS/CONTRAINDICATIONS..................................................... 9
2.1. INDICATIONS FOR USE .........................................................................................................................9
2.2. CONTRAINDICATIONS..........................................................................................................................9
SECTION 3: WARNINGS, PRECAUTIONS, AND ADVERSE EVENTS...................... 10
3.1. WARNINGS.............................................................................................................................................10
3.2. PRECAUTIONS.......................................................................................................................................11
3.3. ADVERSE EVENTS ...............................................................................................................................13
SECTION 4: UNPACKAGING AND REPACKAGING.................................................... 14
4.1. UNPACKAGING.....................................................................................................................................14
4.2. REPACKAGING .....................................................................................................................................14
SECTION 5: CONTROLS, DISPLAYS, AND CONNECTIONS...................................... 15
5.1. FRONT PANEL DISPLAYS, CONTROLS, AND CONNECTIONS.....................................................15
5.2. REAR PANEL DISPLAYS, CONTROLS, AND CONNECTIONS .......................................................17
5.3. GENERATOR STATES FLOW CHART................................................................................................19
SECTION 6: DISPLAYS........................................................................................................ 20
6.1. System Initialization and POST States.....................................................................................................20
6.2. STANDBY State ......................................................................................................................................21
6.3. READY State ...........................................................................................................................................21
6.4. ON State ...................................................................................................................................................22
6.5. ALERT.....................................................................................................................................................22
6.6. FAULT (ERROR) State ...........................................................................................................................23
6.7. SETUP State.............................................................................................................................................23
SECTION 7: DIRECTIONS FOR USE................................................................................ 26
7.1. READ INSTRUCTIONS FOR USE ........................................................................................................26
7.2. CONNECT GENERATOR POWER CORD ...........................................................................................26
7.3. CONNECT FOOTSWITCH (OPTIONAL).............................................................................................26
7.4. CONNECT CONNECTOR CABLE........................................................................................................26
7.5. CONNECT THE DISPERSIVE (RETURN) ELECTRODE ...................................................................27
7.6. TURN THE GENERATOR “ON” ...........................................................................................................28
7.7. SET CUT MODE .....................................................................................................................................28
7.8. SET TIME ................................................................................................................................................28
7.9. CONFIRM GENERATOR SETTINGS AND STATE ............................................................................28
7.10. ACTIVATE RF ENERGY DELIVERY ..................................................................................................28
7.11. DEACTIVATE RF POWER DELIVERY ...............................................................................................29
7.12. RE-APPLY RF POWER ..........................................................................................................................29
7.13. PROCEDURE COMPLETE ....................................................................................................................29
SECTION 8: SERVICE AND MAINTENANCE ................................................................ 30

© 2012-2019 Baylis Medical Company Inc. 5 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
8.1. CLEANING..............................................................................................................................................30
8.2. FUSE REPLACEMENT ..........................................................................................................................30
8.3. DISPOSAL...............................................................................................................................................30
SECTION 9: SPECIFICATIONS.......................................................................................... 31
9.1. TECHNICAL SPECIFICATIONS...........................................................................................................31
9.2. GENERATOR MODE SETTINGS .........................................................................................................33
9.3. OUTPUT ENERGY FIGURES................................................................................................................34
9.4. ALERT CODES .......................................................................................................................................36
9.5. IEC ELECTRICAL SAFETY AND EMC SPECIFICATIONS...............................................................39
9.6. LABELING AND SYMBOLS.................................................................................................................43
SECTION 10: LIMITED WARRANTIES AND DISCLAIMER......................................... 46

© 2012-2019 Baylis Medical Company Inc. 6 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
LIST OF FIGURES
Page
Figure 5-1 - Generator Front Panel............................................................................................... 15
Figure 5-2 - Generator Rear Panel................................................................................................ 17
Figure 5-3 –Generator States Flow Chart.................................................................................... 19
Figure 6-1- System Initialization Display..................................................................................... 20
Figure 6-2- POST Display ............................................................................................................ 20
Figure 6-3- STANDBY State Display.......................................................................................... 21
Figure 6-4a- READY State Display ............................................................................................. 21
Figure 6-5b- READY State Display with Single Dispersive Electrode ....................................... 22
Figure 6-6- ON State Display ....................................................................................................... 22
Figure 6-7- ALERT State Display................................................................................................ 23
Figure 6-8- FAULT (ERROR) State Display............................................................................... 23
Figure 6-9- SETUP State Display - Page 1................................................................................... 24
Figure 6-10- SETUP State Display- Page 2.................................................................................. 25
Figure 9-1 Maximum Power Ouput for Mode 10 Constant.......................................................... 34
Figure 9-2 Maximum Power Ouput for Mode 10 Pulse............................................................... 34
LIST OF TABLES
Page
Table 9.2-1- CUT and TIME settings for each Generator Mode.................................................. 33
Table 9.5-1 IEC Electrical Safety Specifications ......................................................................... 39
Table 9.5-2 IEC EMC Specifications (Emissions) ....................................................................... 39
Table 9.5-3 IEC EMC Specifications (Immunity)........................................................................ 40
Table 9.5-4 IEC Recommended Separation of RF Communication Equipment.......................... 42

© 2012-2019 Baylis Medical Company Inc. 7 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
PREFACE
For the user’s convenience, the Baylis Medical Company Inc. (BMC, or “Baylis Medical”)
Radiofrequency Puncture Generator (model: RFP-100A) will be referred to in this Operator’s
Manual as the “Generator”. The Generator is to be used only with BMC radiofrequency (RF)
devices that have been separately cleared for use with the Generator. These separately cleared
BMC radiofrequency devices include, but are not limited to, the Nykanen Radiofrequency Wire,
the PowerWire®Radiofrequency Guidewire, the NRG®Transseptal Needle, and the VersaCross®
Radiofrequency Wire - they will generally be referred to in this Operator’s Manual as the “BMC
RF Device”. The BMC RF Device is connected to the Generator through the appropriate BMC
connector cable. The DuoModeTM Cable serves as an extension cable that is used with the
Generator, BMC RF devices and diagnostic equipment. The footswitch is an accessory to the
BMC Radiofrequency Puncture Generator.
User covenants not to use the Generator in conjunction with any unauthorized products, items,
consumables, disposables, equipment or parts.
User specifically agrees that Baylis Medical shall not be liable for damages, personal injury or
death if the RF Generator is used in conjunction or with any unauthorized products, items,
consumables, disposables, equipment orparts.
User specifically agrees that Baylis Medical shall not indemnify the Buyer for claims resulting in
damages, personal injury or death if the RF Generator is used in conjunction or with any
unauthorized products, items, consumables, disposables, equipment orparts.
User will not resell or redistribute the Generator to entities or persons, except with Baylis
Medical’s prior written consent.
The use of the BMC 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 BMC RF Devices, please refer to the
instructions for use for the respective BMC RF Device.
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

© 2012-2019 Baylis Medical Company Inc. 8 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
SECTION 1: DEVICE DESCRIPTION
The Generator is a component of the Baylis Medical Company Radiofrequency (RF) Puncture
System. The Generator is operated in conjunction with separately cleared BMC RF Devices, BMC
connector cables such as (but not limited to) the RFX-BAY-TS, RFX-BAY-TS-12-SU or RFX-
BAY-OTW-10-SU cables, an optional DuoModeTM Cable, a commercially available return
(dispersive) electrode that meets or exceeds IEC 60601-2-2:2017, and an optional accessory
footswitch. The Generator delivers energy in a voltage-controlled monopolar mode between the
BMC RF Device’s distal tip electrode and the return electrode. Detailed information regarding the
BMC RF Device is contained in a separate manual that accompanies each BMC RF Device.
The Generator produces continuous radiofrequency power output at a fixed frequency in the range
of 450 kHz to 480 kHz in a monopolar mode. Connections for the Generator connector cable
(which connects to the separately approved BMC RF Device) and a patient return electrode that
meets or exceeds IEC 60601-2-2:2017 areprovided. Controls on the front panel allow the cut mode
and the duration of the RF output to be set. In addition, on/off control of the output can be achieved
through the optional accessory footswitch or through the dedicated front panel button. The elapsed
time and the cut mode are displayed on the liquid crystal display (LCD) during RF energy delivery.
An audible tone synchronized with the RF output is also produced during energy delivery. The
Generator has several built-in safety features, such as device identification, alert messages, an
automatic shut-off for out-of-range parameters or metal contact, and maximum voltage, current,
and power limits.
The Generator has been tested for compliance with the following standards:
•IEC 60601-1:2005+A1:2012
•IEC 60601-2-2:2017
•IEC 60601-1-2:2014

© 2012-2019 Baylis Medical Company Inc. 9 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
SECTION 2: INDICATIONS/CONTRAINDICATIONS
2.1. INDICATIONS FOR USE
The Baylis Medical Company Radiofrequency Puncture Generator & Footswitch is to be
used with separately approved radiofrequency devices in general surgical procedures to
cut soft tissues.
2.2. CONTRAINDICATIONS
The BMC Radiofrequency Puncture Generator is not recommended for uses other than
the indicated use.

© 2012-2019 Baylis Medical Company Inc. 10 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
SECTION 3: WARNINGS, PRECAUTIONS, AND ADVERSE EVENTS
The safe and effective use of RF energy is highly dependent upon factors under the control
of the operator. There is no substitute for properly trained operating room staff. It is
important that the operating instructions supplied with the Generator be read and understood
before use.
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 separately cleared BMC RF Devices, BMC
connector cables, and the accessory footswitch only. For respective devices/accessories,
refer to individual IFUs for more information.
•To avoid risk of electric shock, Generator must only be connected to supply mains with
protective earth.
•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 and electrical 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 perform an RF puncture with an initial cut setting other than that
recommended by the BMC RF Device Instructions for Use. The cut setting (and therefore
output power) should be as low as possible (as recommended for BMC RF device) to avoid
any unintended result.
•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, incorporating
high frequency current limiting devices are recommended.

© 2012-2019 Baylis Medical Company Inc. 11 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
•Skin-to-skin contact (for example between the arms and body of the patient) should be
avoided, for example by insertion of dry gauze.
•During RF output, implanted devices such as pacemakers may be affected. Qualified
advice should be obtained as necessary, to minimize the risk from injury due to implanted
device malfunction.
•Unless a compatible monitoring return electrode that meets or exceeds IEC 60601-2-
2:2017 is used with the contact quality monitor, loss of safe contact between the return
electrode and patient will not result in an auditory alarm.
•The Generator should not be operated if the display area (LCD screen) is cracked or broken.
•Devices should not be used in the presence of flammable materials, chemicals, and
substances (anesthetics, oxygen, etc).
•No modification of Generator is allowed. Modification may result in patient or operator
harm.
•Flammable solutions may pool under the patients or in body depressions such as the
umbilicus, and in body cavities such as the vagina.
•Generator failure can lead to neuromuscluar stimulation.
•When using RF On/Off switch, the Generator can deliver RF energy without continous
depression of RF On/Off switch for the specified treatment time. Failure to specify correct
treatment time could result in an unintended RF delivery.
3.2. PRECAUTIONS
•The Generator is intended for use with separately cleared BMC RF Devices, BMC
connector cables and an optional accessory footswitch only. Ensure that the rated accessory
voltage is equal to or greater than the Generator’s maximum output voltage.
•Ensure that the Generator connector cables and dispersive electrode cables are positioned
in such a way that contact with the patient or other leads is avoided.
•Ensure the application and connections of dispersive electrode before selecting a higher
output setting on generator.
•Temporarily unused Devices should be disconnected from the Generator, from the
Connector Cable or they should be stored in a location that is isolated from the patient.
•It is recommended not to exceed the specified number of RF energy applications per BMC
RF Device, as indicated within the BMC RF Device’s specific instructions for use.

© 2012-2019 Baylis Medical Company Inc. 12 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
•Only physicians thoroughly trained in RF Puncture techniques, in a fully equipped
catheterization laboratory, should perform RF Puncture procedures.
•Read and follow the manufacturer’s instructions for use of the return (dispersive) electrode.
Only use dispersive electrodes that meet or exceed IEC 60601-2-2:2017 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.
•The Generator is capable of delivering significant electrical power. Patient or operator
injury can result from improper handling of the BMC RF Device and dispersive electrode,
particularly when operating the BMC RF Device.
•During RF energy 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 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.
•Regularly inspect and test re-usable connector cables and accessory footswitch.
•Perform regular inspections of all system components, including separately cleared BMC
RF Devices and BMC Connector Cables, for damage to insulations.
•Associated equipment and BMC RF Devices should be selected with a rated accessory
voltage equal to or greater than the maximum output voltage of the mode it is to be used
for.
•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 to avoid the risk of electric shock. Extension cords, portable multiple socket
outlets and/or adapter plugs must not be used. The mains power cord assembly should be
periodically checked for damaged insulation or connectors.
•Although the BMC RF Device and BMC Connector Cables are sterilized, the Generator is
not. The Generator must not enter the surgical sterile field.
•Fluids pooled in the body depressions and cavities should be mopped up before RF energy
is delivered.
•There is a danger of ignition of endogenous gases (e.g., cotton and gauze saturated with
oxygen may be ignited by sparks produced) during normal use of Generator.

© 2012-2019 Baylis Medical Company Inc. 13 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
•The use of a smoke-plume extractor is recommended for the operator during RF
procedures.
3.3. ADVERSE EVENTS
Adverse events that may occur while using the Generator include:
•Atrial Fibrillation and/or Atrial Flutter
•Myocardial Infarction
•Sustained arrhythmias leading to Ventricular Tachycardia
•Neuromuscular stimulation
The BMC RF Device Instructions for Use should be consulted for any other adverse events that
may be associated with use of that separately cleared device.

© 2012-2019 Baylis Medical Company Inc. 14 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
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 the front panel, chassis, or cover for
damage. If any physical damage is found, DO NOT USE THE GENERATOR. CONTACT Baylis
Medical Company for a replacement. Notify the carrier immediately if the shipment carton is
damaged. Verify that the following items are received:
1 Generator
1 User’s Manual
1 Hospital Grade 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.
The Generator may be placed on a mounting cart or on any sturdy table or platform rated to hold
at least 20 lbs. Do not obstruct the vents underneath and at the rear of the Generator.
WARNING: The Generator should not be used adjacent to or stacked with other equipment. If
the Generator must be operated adjacent to or stacked with other equipment, the Generator should
be observed to verify normal operation in that configuration.
Separately cleared accessory medical devices compatible with the Generator include BMC
connector cables such as (but not limited to) the RFX-BAY-TS, RFX-BAY-TS-12-SU or RFX-
BAY-OTW-10-SU cables, an optional DuoModeTM Cable (RFX-BAY-DUO-100A), a
commercially available return (dispersive) electrode that meets or exceeds IEC 60601-2-2:2017
and an optional accessory footswitch (RFA-FS). These devices are packaged separately.
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 components. Do not attempt to
forcefully fit all the components into the carton.

© 2012-2019 Baylis Medical Company Inc. 15 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
SECTION 5: CONTROLS, DISPLAYS, AND CONNECTIONS
5.1. FRONT PANEL DISPLAYS, CONTROLS, AND CONNECTIONS
Descriptions of the front panel displays, controls, and connections are given below. Refer to
Figure 5-1 - Generator Front Panel for their location.
(1) AC Power Indicator: This green LED illuminates when the Generator is turned on.
(2) FAULT Indicator: This red LED illuminates and flashes when a system ERROR has
occurred. System errors include self-test failures, hardware protection errors, hardware
measurement errors, and software failures. Main power to the Generator must be cycled
(off-on) to attempt recovery from a system error. Consult instructions for use.
(3) Ambient Light Sensor: This sensor detects the ambient light level. Screen brightness is
automatically adjusted according to ambient light level (bright (HIGH) in a bright room
and dimmed (LOW) in a dim room).
(4) Return Electrode Fault Indicator: The red LED illuminates when a return electrode is
NOT connected to the generator OR when the measured impedance of a monitoring (dual
foil) return electrode is greater than 150 ohm, indicating poor patient contact. Note: Only
use return electrodes that meet or exceed IEC 60601-2-2:2017 requirements.
8
3
9
5
1
2
6
7
14
12
4
10
13
11
Figure 5-1 - Generator Front Panel
15

© 2012-2019 Baylis Medical Company Inc. 16 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
(5) STATE Status Bar: This window displays the current STATE of the Generator. The
various Generator states and how they are related are shown in Figure 5-3 –Generator
States Flow Chart.
(6) TIME Setting Window: This window displays the desired RF output duration (in
seconds). This window also displays the functions for the soft keys used to adjust the
TIME setting.
(7) Left column soft keys: These keys allow for parameter adjustment. Their function is
displayed on the screen to the right of the soft key, when applicable. For example, the up
▲and down ▼arrows are displayed when the keys are to be used to increase or decrease
a setting.
(8) CUT Setting Window: This window displays the desired CUT mode. CUT modes are
BMC RF Device specific and described in Section 9.3. The BMC RF Device’s
instructions-for-use should be consulted for appropriate settings to use. This window also
displays the function for the soft keys used to adjust the CUT setting.
(9) Right column soft keys: These keys allow for parameter adjustment. Their function is
displayed on the screen to the left of the soft key, when applicable. For example, the up
▲and down ▼arrows are displayed when the keys are to be used to increase or decrease
a setting.
(10) Bottom row soft keys: These soft keys have various functions. Each key’s function is
displayed on the screen above the soft key when applicable.
(11) Message Window: This window displays functional and informational messages when
required.
(12) Return Electrode Connection: This patient isolated connection is for attachment of an
approved dispersive (return) electrode. Only use dispersive electrodes that meet or
exceed IEC 60601-2-2:2017 requirements. Either non-monitoring (single foil) or
monitoring (dual foil) electrodes can be used.
(13) Connector Cable Connection: This patient isolated connection is for the attachment of
the RFP-100A connector cable. The user shall refer to the BMC RF Device instructions-
for-use to select the proper connector cable model.
(14) RF ON/OFF Button and Indicator: Upon press and release, this button initiates RF
energy delivery when the Generator is in the READY state. This button terminates RF
energy delivery when the Generator is in the ON state. The indicator in the button
illuminates yellow when the Generator is in the ON state.
(15) USB Port (side): When a USB memory stick is connected, treatment data from the last
twenty (20) RF energy deliveries is downloaded. When left connected, data from
subsequent RF deliveries is downloaded on a per treatment basis.

© 2012-2019 Baylis Medical Company Inc. 17 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
5.2. REAR PANEL DISPLAYS, CONTROLS, AND CONNECTIONS
Descriptions of the rear panel displays, controls, and connections are given below. Refer to
Figure 5-2 - Generator Rear Panel for their location.
(1) AC Mains Switch: This switch controls the initial AC mains power input to the
Generator. It is part of the power entry module which also contains the fuse drawer and
AC power cord connector.
(2) AC Power Cord Connection: This connection is for the attachment of a hospital grade
power cord.
(3) Fuse Drawer: This fuse drawer contains the fuses that protect the generator from
excessive AC mains current.
(4) Equipotential Ground Connection: This connector is attached to the chassis/earth
ground. It is intended for earth reference connection in environments where equipotential
ground cabling is used.
(5) FOOTSWITCH Connection: This connection is for the attachment of the
FOOTSWITCH. Like the RF ON/OFF button, the FOOTSWITCH initiates and
terminates RF energy delivery. However, its action is different than the RF ON/OFF
Figure 5-2 - Generator Rear Panel
7
8
0
5
6
4
3
2
1
9

© 2012-2019 Baylis Medical Company Inc. 18 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
button. The FOOTSWITCH must be pressed and held in the READY state to deliver RF
energy and it must be released to terminate RF energy delivery.
(6) USB Connection (covered): Connection to be used by authorized service personnel only.
(7) Fan: A brushless DC fan is used to exhaust warm air from the Generator. The direction
of flow is outward from the rear panel.
(8) TUV Product Service (c-us) Mark Label
(9) Device Label: This label indicates the model number, serial number, and manufacturer
contact information. Symbols found on this label are described in Section 9.6.

© 2012-2019 Baylis Medical Company Inc. 19 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
5.3. GENERATOR STATES FLOW CHART
Figure 5-3 –Generator States Flow Chart

© 2012-2019 Baylis Medical Company Inc. 20 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
SECTION 6: DISPLAYS
6.1. System Initialization and POST States
•The System Initialization state is initiated when the Generator is turned on. It lasts for
approximately 40s.
•The AC Power Indicator is illuminated and a splash screen appears. The screen will
go blank for approximately 20 seconds.
Figure 6-1- System Initialization Display
•The Power On Self Test (POST) state is initiated after System Initialization is
complete. It lasts for approximately 10s.
•The FAULT indicator illuminates during POST.
•The Return Eletrode Fault Indicator and RF ON/OFF indicator flash briefly during
POST.
•A tone is sounded once POST is successfully completed.
•If the Generator does not enter POST, then it will be considered as an error (see
FAULT state).
Figure 6-2- POST Display