BMC RADIOFREQUENCY PUNCTURE GENERATOR RFP-100A User Manual V-9 March 2019

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TABLE OF CONTENTS LIST OF FIGURES ... 5 LIST OF TABLES ... 5 PREFACE

... 6

SECTION 1:

DEVICE DESCRIPTION ... 7

SECTION 2:

INDICATIONS/CONTRAINDICATIONS ... 8

2.1. 2.2.

INDICATIONS FOR USE ...8 CONTRAINDICATIONS ...8

SECTION 3: 3.1. 3.2. 3.3.

SECTION 4: 4.1. 4.2.

DISPLAYS ... 19

System Initialization and POST States ... 19 STANDBY State ... 20 READY State ... 20 ON State ... 21 ALERT ... 21 FAULT (ERROR) State ... 22 SETUP State ... 22

SECTION 7: 7.1. 7.2. 7.3. 7.4. 7.5. 7.6. 7.7. 7.8. 7.9. 7.10. 7.11. 7.12. 7.13.

CONTROLS, DISPLAYS, AND CONNECTIONS ... 14

FRONT PANEL DISPLAYS, CONTROLS, AND CONNECTIONS ... 14 REAR PANEL DISPLAYS, CONTROLS, AND CONNECTIONS ... 16 GENERATOR STATES FLOW CHART ... 18

SECTION 6: 6.1. 6.2. 6.3. 6.4. 6.5. 6.6. 6.7.

UNPACKAGING AND REPACKAGING ... 13

UNPACKAGING ... 13 REPACKAGING ... 13

SECTION 5: 5.1. 5.2. 5.3.

WARNINGS, PRECAUTIONS, AND ADVERSE EVENTS ... 9

WARNINGS...9 PRECAUTIONS... 10 ADVERSE EFFECTS ... 12

DIRECTIONS FOR USE ... 25

READ INSTRUCTIONS FOR USE ... 25 CONNECT GENERATOR POWER CORD ... 25 CONNECT FOOTSWITCH (OPTIONAL) ... 25 CONNECT CONNECTOR CABLE ... 25 CONNECT THE DISPERSIVE (RETURN) ELECTRODE ... 26 TURN THE GENERATOR “ON” ... 27 SET CUT MODE ... 27 SET TIME ... 27 CONFIRM GENERATOR SETTINGS AND STATE ... 27 ACTIVATE RF ENERGY DELIVERY ... 28 DEACTIVATE RF POWER DELIVERY ... 28 RE-APPLY RF POWER ... 28 PROCEDURE COMPLETE ... 28

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SECTION 8: 8.1. 8.2.

SECTION 9: 9.1. 9.2. 9.3. 9.4. 9.5. 9.6.

SERVICE AND MAINTENANCE ... 29

CLEANING ... 29 FUSE REPLACEMENT ... 29

SPECIFICATIONS... 30

TECHNICAL SPECIFICATIONS ... 30 GENERATOR MODE SETTINGS ... 32 OUTPUT ENERGY FIGURES ... 33 ALERT CODES ... 35 IEC ELECTRICAL SAFETY AND EMC SPECIFICATIONS ... 37 LABELING AND SYMBOLS ... 41

SECTION 10: LIMITED WARRANTIES AND DISCLAIMER... 43

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LIST OF FIGURES

Page Figure 5-1 - Generator Front Panel ... 14 Figure 5-2 - Generator Rear Panel ... 16 Figure 5-3 – Generator States Flow Chart ... 18 Figure 6-1- System Initialization Display ... 19 Figure 6-2- POST Display ... 19 Figure 6-3- STANDBY State Display ... 20 Figure 6-4- READY State Display ... 20 Figure 6-5- ON State Display ... 21 Figure 6-6- ALERT State Display ... 21 Figure 6-7- FAULT (ERROR) State Display ... 22 Figure 6-8- SETUP State Display - Page 1 ... 22 Figure 6-9- SETUP State Display- Page 2 ... 23 Figure 9-1 Maximum Power Ouput for Mode 10 Constant ... 33 Figure 9-2 Maximum Power Ouput for Mode 10 Pulse ... 33 LIST OF TABLES

Page Table 9.2-1- CUT and TIME settings for each Generator Mode ... 32 Table 9.5-1 IEC Electrical Safety Specifications ... 37 Table 9.5-2 IEC EMC Specifications (Emissions) ... 37 Table 9.5-3 IEC EMC Specifications (Immunity) ... 38 Table 9.5-4 IEC Recommended Separation of RF Communication Equipment ... 40

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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 may be used with radiofrequency (RF) devices that have been separately cleared for use with the Generator. These separately cleared radiofrequency devices include, but are not limited to, the Nykanen Radiofrequency Wire, the PowerWire® Radiofrequency Guidewire, and the NRG® Transseptal Needle - they will generally be referred to in this Operator’s Manual as the “RF Device”. The 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, RF devices and diagnostic equipment. The footswitch is an accessory to the BMC Radiofrequency Puncture Generator. 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 RF Devices, please refer to the instructions for use for the respective RF Device.

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 Generator is a component of the Baylis Medical Company Radiofrequency Puncture System. The Generator is operated in conjunction with separately cleared RF Devices, BMC connector cables such as (but not limited to) the RFX-BAY-TS, RFX-BAY-TS-12-SU or RFXBAY-OTW-10-SU cables, an optional DuoModeTM Cable, a commercially available return (dispersive) electrode that meets or exceeds IEC 60601-2-2:2009, and an optional accessory footswitch. The Generator delivers energy in a voltage-controlled monopolar mode between the RF Device’s distal tip electrode and the return electrode. Detailed information regarding the RF Device is contained in a separate manual that accompanies each RF Device. The Generator produces continuous radiofrequency (RF) 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 RF Device) and a patient return electrode that meets or exceeds IEC 60601-2-2:2009 are provided. 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 o CB: 7169003394-000 IEC 60601-2-2:2009 IEC 60601-1-2:2014

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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.

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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 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 RF Device Instructions for Use. The cut setting (and therefore output power) should be as low as possible (as recommended for 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.

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

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 60601-22:2009 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 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 RF Device, as indicated within the RF Device’s specific instructions for use.

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

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 60601-2-2:2009 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 RF Device and dispersive electrode, particularly when operating the 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 RF Devices and BMC Connector Cables, for damage to insulations.



Associated equipment and 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 RF Device and 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.

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

3.3.

The use of a smoke-plume extractor is recommended for the operator during RF procedures.

ADVERSE EFFECTS

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 RF Device Instructions for Use should be consulted for any other adverse events that may be associated with use of that separately cleared device.

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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 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 1 1

Generator User’s Manual 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.

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.

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SECTION 5: CONTROLS, DISPLAYS, AND CONNECTIONS 1

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1 0 Figure 5-1 - Generator Front Panel

13

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 60601-2-2:2009 requirements.

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(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 RF Device specific and described in Section 9.3. The 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 60601-2-2:2009 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 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.

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9

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10

11

5

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7

8

Figure 5-2 - Generator Rear Panel 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

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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) Line In Connection: This connection is reserved for future use. (7) RJ45 Connection: Connection to be used by authorized service personnel only. (8) USB Connection (covered): Connection to be used by authorized service personnel only. (9) Fan: A brushless DC fan is used to exhaust warm air from the Generator. The direction of flow is outward from the rear panel. (10) TUV Product Service (c-us) Mark Label (11) InMetro Mark Label (12) 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.

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5.3. GENERATOR STATES FLOW CHART

Figure 5-3 – Generator States Flow Chart

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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 30s. The AC Power Indicator is illuminated and a splash screen appears. The screen will go blank for approximately 15 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.

Figure 6-2- POST Display

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6.2. STANDBY State    

The Standby State is initiated upon successful completion of the POST state. TIME and CUT settings can be adjusted with the left and right soft keys beside the arrows. Messages instruct the user to connect a Valid Device and Return Electrode (Grounding Pad). RF energy delivery cannot be initiated.

Figure 6-3- STANDBY State Display

6.3. READY State   

The Ready State is initiated when a Return Electrode (Grounding Pad) is connected AND a valid device is connected OR when RF energy delivery is terminated. TIME and CUT settings can be adjusted with the left and right soft keys beside the arrows. RF energy delivery can be initiated by either pressing the RF ON/OFF button or pressing and holding FOOTSWITCH.

Figure 6-4- READY State Display

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