BMC RADIOFREQUENCY PUNCTURE GENERATOR Instructions V-13 Jan 2012

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: +1 (514) 488-9801 Fax: +1 (514) 488-7209

EU Authorized Representative:

Quality First International 20 Eversley Road Bexhill-on-Sea East Sussex TN40 1HE United Kingdom Phone: +44-(20)-8-522-1937 Fax: +44-(20)-8-522-1937

0120

2 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc

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. 2.2.

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

SECTION 3: 3.1. 3.2. 3.3.

SECTION 4: 4.1. 4.2.

PORTS/CONNECTORS ... 22

ISOLATED PATIENT CONNECTIONS ...22 FOOTSWITCH CONNECTOR ...22 POWER CONNECTOR ...22 SERIAL PORT ...22 EQUIPOTENTIAL GROUND CONNECTION:...23

SECTION 7: 7.1. 7.2. 7.3. 7.4. 7.5. 7.6.

CONTROLS AND DISPLAYS ... 13

GENERATOR SOFTWARE FLOW CHART ...15 RF ON/OFF BUTTON/LIGHT ...16 POWER ...17 TIME ...18 IMPEDANCE DISPLAY ...19 SET INDICATOR ...19 MEASURED INDICATOR ...19 FAULT INDICATOR ...20 POWER SWITCH ...20 VOLTAGE SELECTOR SWITCH ...20 FOOTSWITCH ...20

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

UNPACKAGING AND REPACKAGING ... 12

UNPACKAGING ...12 REPACKAGING ...12

SECTION 5: 5.1. 5.2. 5.3. 5.4. 5.5. 5.6. 5.7. 5.8. 5.9. 5.10. 5.11.

WARNINGS, PRECAUTIONS, AND ADVERSE EVENTS ... 9

WARNINGS ... 9 PRECAUTIONS ...10 ADVERSE EFFECTS ...11

DIRECTIONS FOR USE ... 24

READ INSTRUCTIONS FOR USE ...24 VERIFY VOLTAGE SELECTOR SETTING ...24 CONNECT GENERATOR POWER CORD ...24 CONNECT BMC RFP CONNECTOR CABLE ...24 CONNECT THE DIP ELECTRODE ...25 TURN THE GENERATOR “ON” ...25

3 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc

7.7. 7.8. 7.9. 7.10. 7.11. 7.12.

SELECT POWER LEVEL ...26 SET TIME DURATION ...26 CONFIRM GENERATOR AND ACCESSORY SETTINGS AND STATE ...26 RF POWER DELIVERY ...26 TURNING RF POWER “OFF” ...27 RE-APPLY RF POWER ...27

SECTION 8: 8.1. 8.2.

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

SERVICE AND MAINTENANCE ... 28

CLEANING ...28 FUSE REPLACEMENT ...28

SPECIFICATIONS... 29

GENERAL SPECIFICATIONS ...29 POWER DELIVERY ...31 OUTPUT POWER GRAPHS...32 ERROR CODES...34 IEC ELECTRICAL SAFETY AND EMC SPECIFICATIONS ...35 LABELING AND SYMBOLS...39

SECTION 10:

LIMITED WARRANTIES AND DISCLAIMER... 41

4 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc

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

5 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc

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.

6 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc

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.

7 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc

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.

8 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc

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. 9 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc

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.

10 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc

•

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.

11 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc

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 1 1

Generator Operator’s Manual 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.

12 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc

SECTION 5: CONTROLS AND DISPLAYS

C F

Figure 5-1 Generator Front Panel

L

J

K

H

I

M

N

A E

G

B D

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.

13 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc

5.1.

GENERATOR SOFTWARE FLOW CHART Generator Off Generator turned on

POST Mode • Self diagnostics

Failed test

Generator passes self-tests

READY Mode • • •

SET indicator lit Time can be adjusted Power can be adjusted

FAIL Mode • •

Either • RF ON/OFF button pressed • Footswitch depressed

•

Fault indicator lit Impedance display flashes error code Contact Baylis Medical Company

ON Mode • • After 5 seconds in DONE 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 Either • • • •

Non-recoverable fault

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

Figure 5-3 - Software Flow Chart 15 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc

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.

16 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc

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).

17 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc

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).

18 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc

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.

19 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc

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 220240V~). 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

20 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc

is released, 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. •

FOOTSWITCH LABEL “READY” Mode

“ON” Mode

“DONE” Mode Timer elapsed

Footswitch released

Footswitch Pressed

ON/OFF button pressed

21 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc