Maestro 4000 Cardiac Ablation System Operators Manual

WARNING: Do not attempt to operate the Maestro 4000™ Cardiac Ablation System prior to reading

this entire Operator’s Manual. All instructions should be understood, and followed carefully. For future reference, keep this manual in a convenient, readily accessible place.

ONLY Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

DEVICE DESCRIPTION Maestro 4000 Cardiac Ablation System The Maestro 4000 Cardiac Ablation System is a non-sterile product that supplies radiofrequency energy to catheters during ablation procedures. The System is compatible with all BSC cardiac ablation catheters including BSC open-irrigated catheters used in conjunction with the MetriQ™ Pump and MetriQ Irrigation Tubing Set. Note: Throughout this manual, the term “System” refers to the Maestro 4000 Cardiac Ablation System.

Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in Global), Maestro 4000 Cardiac Ablation System Operator’s Manual, Global, 90813738-01E

Maestro 4000 Controller The Maestro 4000 Controller is an RF Generator specifically designed for cardiac ablation. It produces userselectable power-controlled or temperature-controlled RF power output in the range of 0 to 150 watts into a nominal tissue impedance of 100 ohms. It delivers RF power via a monopolar method driving current between a single active electrode at the tip of the ablation catheter and one or two dispersive pads applied on the skin. When used with BSC open-irrigated catheters, the RF Generator communicates with the MetriQ Pump to coordinate delivery of RF energy with irrigation flow to the catheter tip. Note: Throughout this manual, the term RF Generator, or Generator, refers to the Maestro 4000 Controller.

Maestro 4000 Pod The Pod, which is connected to the RF Generator, allows connection to all BSC catheters and provides connections for dispersive pad(s) to complete the RF circuit. The Pod also connects to EP recording systems and provides RF filtering to allow continuous electrogram recording during RF delivery. The Pod model varies by operating territory and determines the maximum power setting allowed by the RF Generator. Maestro 4000 Remote Control The optional Remote allows the user to control the RF Generator with up to 75 feet between the user interface and the sterile field. Maestro Foot Switch The optional Foot Switch provides hands-free control to start/stop RF delivery. Dispersive Pads A Dispersive Pad provides external patient contact to complete the RF circuit. It disperses current over a large area to minimize damage due to heating of skin and underlying tissue. It is also known as the DIP (dispersive indifferent pad), ground pad, or return pad.

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User Profile The Maestro 4000™ Cardiac Ablation System should be used only by physicians fully trained in cardiac electrophysiology. EP lab staff members may prepare the Maestro 4000 Cardiac Ablation System for use and assist with operation of the RF Generator. Contents The RF Generator and Pod are packaged separately as: • (1) Maestro 4000 Controller • (1) Maestro 4000 Pod, 100W or (1) Maestro Pod, 150W

INTENDED USE/INDICATIONS FOR USE The Maestro 4000 Cardiac Ablation System is intended for use with BSC cardiac ablation catheters in cardiac ablation procedures. Note: Refer to the individual catheter Directions for Use for catheter compatibility to the Maestro 4000 Cardiac Ablation System. It is also important to carefully review the specific indications, contraindications, warnings, precautions and adverse events included with each catheter, prior to use of the catheter with the Maestro 4000 Cardiac Ablation System.

CONTRAINDICATIONS There are no specific contraindications for use of the Maestro 4000 Cardiac Ablation System itself. However, users should read and understand the specific indications, contraindications, warnings, and precautions included with any cardiac ablation catheter used in conjunction with the System. Note: The contraindications listed in the catheter Directions For Use also apply to the use of the Maestro 4000 Cardiac Ablation System. Carefully review the specific indications, contraindications, warnings, precautions, and adverse events included with each catheter, prior to use of the catheter with the Maestro 4000 Cardiac Ablation System.

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Optional Accessories The MetriQ™ Pump, Maestro 4000 Remote Control, Maestro 4000 Foot Switch, and communication cables required for optional equipment such as the MetriQ Pump, Maestro 4000 Remote Control, or connection to an EP recording system are packaged and sold separately. • MetriQ Pump, Model 4100 • Maestro 4000 Remote Control, Model 4020 • Maestro 4000 Foot Switch, Model 21850 • Cable, Generator to Pump or Remote • Model 661, 20 ft. • Model 662, 25 ft. • Model 663, 50 ft. • Model 664, 75 ft. • Pod to EGM Cable Model 653S

ADVERSE EVENTS

Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in Global), Maestro 4000 Cardiac Ablation System Operator’s Manual, Global, 90813738-01E

Users should also read and understand the specific indications, contraindications, warnings, and precautions included with any catheter used in conjunction with the System. Potential adverse events associated with the use of the Maestro 4000™ Cardiac Ablation System are, but not limited to, the following: • • • • • • • • • • • • • • • • • • •

Additional intervention required Arrhythmia Burns Cardiac Arrest Cardiac Tamponade Cerebral Vascular Accident (CVA) Complete Heart Block Conduction Pathway Injury Congestive Heart Failure Death Discomfort Edema Electrical Shock Embolism Esophagitis Exposure to Biohazardous Material Fistula Hematoma Infection

• • • • • • • • • • • • • • • • • • •

Injury (Not Otherwise Specified) Laceration Myocardial Infarction Myocardial Trauma Necrosis Nerve Injury Perforation Pericardial Effusion Pericarditis Pleural Effusion Prolonged Procedure Renal damage/failure Respiratory Distress/Insufficiency Swallowing Disorders Tissue Damage Transient Ischemic Attack (TIA) Vasospasm Vessel Occlusion Vessel Trauma

HOW SUPPLIED The Maestro 4000 Cardiac Ablation System components are supplied as non-sterile in corrugated boxes. Do not use if package is opened or damaged. Do not use if labeling is incomplete or illegible. Handling and Storage Operating Environment Ambient Temperature: 10 °C to 40 °C Relative Humidity: 30% to 75% Atmospheric Pressure: 70 kPa to 106 kPa

Storage Environment Ambient Temperature: 20 °C to 30 °C Relative Humidity: Uncontrolled Atmospheric Pressure: Uncontrolled

Transport Environment Temperature: -29 °C to 60 °C Relative Humidity: 30% to 85% Atmospheric Pressure: Uncontrolled

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SYSTEM CONTROLS, DISPLAYS AND INDICATORS The controls and displays for the Maestro 4000™ Cardiac Ablation System are located on the front panel of the RF Generator and are duplicated on the front panel of the optional Remote. These two control panels are identical except that the RF Generator’s front panel also has an Isolated Patient Connection for the System’s Pod. Since the front panels are the same, only the RF Generator front panel is illustrated in Figure 1. D. Temperature Display

B. Power Display V. Maximum Button U. Average Button

F. Impedance Display

C. Temperature Setting Adjustment

A. Power Setting Adjustment

T. Control Mode Indicators

E. Impedance H. Time Display Setting Adjustment G. Time Setting Adjustment I. Clear Counter Button

S. Control Mode Button

J. View Settings Button

O. Alphanumeric Display

K. RF Power Control Button

R. Generator Remote Button

L. Mains Power Switch

W. Isolated Patient Connector (Controller only)

N. Memory Buttons

M. System Fault Indicator

Figure 1. RF Generator Front Panel Power Setting Adjustment...6 Power Display...6 Temperature Setting Adjustment...6 Temperature Display...6 Impedance Setting Adjustment...6 Impedance Display...6 Time Setting Adjustment...7 Time Display...7 Clear Counter Button...7 View Settings Button...7 RF Power Control Button...7

L. Mains Power Switch...7 M. System Fault Indicator...9 N. Memory Buttons...7 O. Alphanumeric Display...8 P. Active/Inactive Panel...9 R. Generator-Remote Button...8 S. Control Mode Button...8 T. Control Mode Indicators...9 U. Average Button...9 V. Maximum Button...9 W. Isolated Patient Connector ...9

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P. Active/ Inactive Panel

Power Setting Adjustment ) will increase or decrease the RF power • A single press of a Power Setting Adjustment Button ( setting in 1-watt increments in both STANDBY and DELIVER states. • Pressing and holding the Power Setting Adjustment Buttons ( ) allows rapid scrolling of the RF power setting in STANDBY state only. • The adjustment range varies by catheter/pod type (See Table 1 Adjustment Ranges for Power and Temperature). Power Display • In STANDBY state, the RF Power setting is displayed. • In DELIVER state, the measured RF Power is displayed. • Temperature Setting Adjustment: A single press of the Temperature Setting Adjustment Button ( ) will increase or decrease the catheter tip temperature setting by 1 °C increments in both STANDBY and DELIVER states. • Pressing and holding the Temperature Setting Adjustment Buttons ( ) allows rapid scrolling of the catheter tip temperature setting in STANDBY state only. • The adjustment range varies by catheter/pod type and the control mode selected (See Table 1 Adjustment Ranges for Power and Temperature).

Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in Global), Maestro 4000 Cardiac Ablation System Operator’s Manual, Global, 90813738-01E

Temperature Display • In STANDBY state, the temperature setting is displayed. • In DELIVER state: • Measured catheter tip temperature is displayed (between 15 °C and 95 °C). • Three dashes (---) will be displayed when the measured temperature is below 15 °C and above 95 °C. Impedance Upper Limit Adjustment ) will increase or decrease the • A single press of the Impedance Setting Adjustment Button ( impedance upper limit setting by 1 Ω increments in both STANDBY and DELIVER states. • Pressing and holding the Impedance Setting Adjustment Buttons ( ) allows rapid scrolling of the impedance upper limit setting in STANDBY state only. • The adjustment range for the impedance upper limit is 150 Ω to 300 Ω. Impedance Display • In STANDBY state, the impedance upper limit setting is displayed. • In DELIVER state, the measured impedance is displayed. • The impedance display will flash “HI” and RF power will shut off if the measured impedance rises above the upper limit during RF delivery. • The impedance display will flash “LO” and RF power will shut off if the measured impedance falls below the low impedance limit for the catheter during RF delivery. • The low impedance limit for high-power catheters is 25 Ω. • The low impedance limit for non-high-power catheters is 50 Ω.

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Time Setting Adjustment • The Time Setting Adjustment Button increases or decreases the maximum duration for RF power delivery in one-second increments during STANDBY state only. ) will increase or decrease the time by 1 second. • A single press of the Time Setting Adjustment Button ( • Pressing and holding the Time Adjust Buttons ( ) allows rapid scrolling of the time setting. • The range for the maximum duration setting varies by catheter type. • The range for open-irrigated catheters is 0 – 999 seconds. • The range for all other catheter types is 0 – 120 seconds.

Note: The maximum duration must be set to at least 4 seconds to start RF delivery.

Time Display • In STANDBY state, the setting for maximum duration of RF power is displayed. • In DELIVER state, the display changes to zero seconds at the onset of RF delivery, and then counts up to the maximum duration (unless delivery is manually terminated). Clear Counter Button • The Clear Counter Button resets the count of valid RF deliveries to zero and resets the total RF delivery time to zero. • This button is inactive during RF delivery.

RF Power Control Button • Press to start RF delivery while in STANDBY state. • Press to stop RF delivery while in DELIVER state. • Press to clear a DIAGNOSTIC message and exit DIAGNOSTIC state. Mains Power Switch • The Mains Power Switch turns the unit ON and OFF. Memory Buttons • Memory Buttons - allow RF delivery settings to be stored and recalled. • Select the desired Control Mode, Power, Temperature, Impedance, Time, and status of the Maximum and Average Buttons (ON or OFF) • To store these values, press and hold a Memory button for at least two seconds until audible tone confirms that settings have been saved. • To recall the settings, press and release the appropriate Memory button. • The Memory buttons are inactive during RF power delivery.

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View Settings Button • During RF delivery, pressing and holding the View Settings Button temporarily displays the settings for Power, Temperature, Impedance, and Time instead of the measured values.

Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in Global), Maestro 4000 Cardiac Ablation System Operator’s Manual, Global, 90813738-01E

Alphanumeric Display In STANDBY state • Measured temperature is displayed between 15 °C – 95 °C (Outside this range, the display reads “D06-TEMP OUT OF RANGE [15C-95C]”). • Measured impedance is displayed between 0-300 Ω (Over 300 Ω, the display reads “HI”). • Operational messages (M06 to M10) alert the operator to special conditions (without entering DIAGNOSTIC state). See OPERATIONAL MESSAGES Section for additional information. In DELIVER state • Operational messages (M02 to M05 and M11) alert the operator to special conditions affecting the delivery of RF (without entering DIAGNOSTIC state). See OPERATIONAL MESSAGES Section for additional information. In Both STANDBY and DELIVER states • The count of valid RF deliveries and total RF delivery time are displayed. • A valid delivery is defined as an RF application greater than 4 seconds. • After 999 deliveries, the counter will roll over to zero. • The total RF delivery time is displayed in MM:SS format. • The counter should be cleared between patients. • Upon initial power ON, the counter clears automatically • Reconnecting a catheter within 20 minutes will not reset the counter. If a catheter is reconnected after 20 minutes, the counter will be reset. • Average and maximum values for power, temperature, and impedance are displayed if the feature is selected. • Diagnostic codes (D01 – D12) alert the operator to a diagnostic condition. See DIAGNOSTIC MESSAGES Section for additional information. Generator-Remote Button • The Generator-Remote buttons toggle the Generator and Remote Control panels between active and inactive states. • All controls are functional on the active panel. • The following controls remain fully or partially functional on the “inactive” panel: • The RF Power Control button can be used to stop RF power. • The Generator-Remote and View Settings buttons are fully functional. • The Generator-Remote Button is inactive during RF power delivery. Control-Mode Button • Pressing the Control-Mode Button toggles the unit between the Power-Control and TemperatureControl modes of operation. • The button is inactive during RF power delivery.

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Average Button • When the Average Button is pressed in STANDBY state, the average values of power, temperature and impedance for the previous ablation are shown in the alphanumeric display. • When the Average Button is pressed in DELIVER state, the average values of power, temperature and impedance for the current ablation are shown in the alphanumeric display. Maximum Button • When the Maximum Button is pressed in STANDBY state, the maximum values of power, temperature and impedance for the previous ablation are shown in the alphanumeric display. • When the Maximum Button is pressed in DELIVER state, the maximum values of power, temperature and impedance for the current ablation are displayed in the alphanumeric display. Isolated Patient Connector Provides for connection of the Pod to the RF Generator.

System Fault Temperature Mode Power Mode RF Power Control RF Power Control Memory Panel Active Panel Inactive Average Maximum

Red Green Green Flashing Amber Solid Amber Green Green Yellow Green Green

Indicates a System Fault has occurred. Indicates System is in Temperature-Control Mode Indicates System is in Power-Control Mode Indicates System is in STANDBY state Indicates System is in RF DELIVER state Indicates settings are loaded from memory Indicates the Control Panel is active Indicates the Control Panel is inactive Indicates the Average feature is active Indicates the Maximum feature is active

Remote (Optional Accessory) The Remote allows an operator access to all controls, displays, and indicators while at a distance from the RF Generator. The Remote can be connected to the RF Generator with cables of various lengths. All controls, displays, and indicators on the Remote have the same appearance and function as those on the RF Generator. Foot Switch (Optional Accessory) A Foot Switch with a 10 foot cable can be connected to the RF Generator. The Foot Switch provides hands-free control to start/stop RF delivery. The Foot Switch functions similarly to the RF Power Control button except that the operator must continuously hold the Foot Switch down for RF power to be delivered. RF power delivery is immediately terminated when the operator’s foot is lifted off the Foot Switch. Pressing and releasing the Foot Switch can also be used to clear diagnostic messages and exit diagnostic state.

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Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in Global), Maestro 4000 Cardiac Ablation System Operator’s Manual, Global, 90813738-01E

Front Panel Indicators The front panel indicators include the following:

Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in Global), Maestro 4000 Cardiac Ablation System Operator’s Manual, Global, 90813738-01E

SYSTEM INSTALLATION This section provides installation instructions for the Maestro 4000™ Cardiac Ablation System. • WARNING: No modification of this equipment is allowed other than the specified fuses, as this may result in electrical shock and/or other unexpected consequences. • WARNING: To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. • WARNING: A Hospital Grade power cord (such as those supplied with the Maestro) must be used to connect the RF Generator or Remote Mains Power Inlet to an AC wall outlet designated as “Hospital Grade” or “Hospital Only.” • WARNING: Do not use an extension cord with the System and do not connect the System’s power supply cord to an additional multiple portable socket. • WARNING: Equipment connected to the analog and digital interfaces of the System must be certified to the respective IEC standards (i.e. IEC 950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-1-1 (or 60601-1 3rd edition). Any user who connects additional equipment to the signal input ports or signal output ports configures a medical system, and is therefore responsible for the compliance of that system with the requirements of the system standard IEC 60601-1-1 (or 60601-1 3rd edition). • WARNING: Electromagnetic interference (EMI) produced by the RF Generator during delivery of RF power may adversely affect the performance of other equipment. The user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving device, increase the separation between the equipment, connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected. Consult your local BSC field service technician for help. The use of accessories, transducers and cables other than those specified may result in increased electromagnetic emissions or decreased electromagnetic immunity of the System. EMC installation and service information is provided in the Maestro 4000 Cardiac Ablation System Safety Specifications section. • WARNING: Components of the Maestro 4000 Cardiac Ablation System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Maestro 4000 Cardiac Ablation System should be observed to verify normal operation in the configuration in which it will be used. • WARNING: When physiological monitoring equipment is used on the same patient, any monitoring electrodes should be placed as far as possible from the ablation electrodes. Needle monitoring electrodes are not recommended. Monitoring systems incorporating high frequency current-limiting devices are recommended. • WARNING: The cables connecting the catheter to the System should be positioned in such a way that contact with the patient or other leads is avoided. • WARNING: During power delivery, the patient should not come into contact with metal parts which are electrically connected to earth ground or which have an appreciable capacitance to earth (such as operating table supports, etc.). The use of antistatic sheeting is recommended. • WARNING: Skin-to-skin contact (for example between the arms and body of the patient) should be avoided, for example by insertion of dry gauze.

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•

•

•

•

•

•

WARNING: There is a possibility of skin burns to the patient during ablation therapy. The use of dispersive pads, which meet or exceed IEC 60601-2-2 requirements, is required. The entire area of the dispersive pad should be reliably attached to the patient’s body as close to operating field as possible. Refer to the manufacturer’s directions for use for proper application. When using BSC high-power catheters, it is required that two dispersive pads be used. WARNING: The Pod cable is permanently attached to the Pod. Do not attempt to loosen or remove this cable from the Pod. Do not attempt to rotate or twist the connector itself. Caution: Pins of connectors identified with the ESD warning symbol should not be touched and connections should not be made to these connectors unless ESD precautionary procedures are used. It is recommended that all staff involved in the assembly and/or installation of the Maestro 4000™ Cardiac Ablation System receive an explanation of the ESD warning symbol and training in ESD precautionary procedures. Caution: Portable and mobile RF communications equipment can affect the Maestro 4000 Cardiac Ablation System. It is advised not to use this equipment in proximity to the Maestro 4000 Cardiac Ablation System. Caution: Adequate filtering must be used to allow continuous monitoring of the surface electrocardiogram (ECG) during RF power applications. Note: The RF Generator, Pod, and if used, the Remote Control and Foot Switch, are intended for installation within the Patient Environment.

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 Note: The Patient Environment is described per IEC 60601-1 as any volume in which intentional or unintentional contact can occur between Patients and parts of the System, or between Patient and other persons touching parts of the System.

RF Generator Rear Panel This section describes the connections and controls on the rear panel of the cardiac RF Generator shown in Figure 2. EP Recording System Connector Peristaltic Pump Connector

Remote Connector

Foot Switch Cable Connector

Speaker Volume

Peristaltic Pump

Mains Power Inlet

VA POWER INPUT Hz FREQUENCY AC VOLTAGE W kHz

300 VA 50/60 Hz 100-120 / 220-240V

RATED OUTPUT POWER RATED LOAD OPERATING FREQUENCY

Maestro 4000™ Controller RF Cardiac Ablation Controller

50, 100, 150 100 460

M00440000 REF

Catalog No. Date of Manufacture

SN

Serial Number

4000 YYYY-MM-DD 12345678

Made In USA: 560 Cottonwood Drive Milpitas, CA 95035 USA

C

US

cTUVus Mark indicates compliance to UL 60601-1 and CAN/CSA 22.2 601.1 M90 covering electrical safety requirements for the US and Canada.

871-0186-000 REV A

Separate Collection

Follow Instructions For Use

90818618-01A

Equipotentiality Terminal

Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in Global), Maestro 4000 Cardiac Ablation System Operator’s Manual, Global, 90813738-01E

Figure 2. RF Generator Rear Panel Mains Power Inlet The Mains Power Inlet connects to an AC wall outlet designated as “Hospital Grade” or “Hospital Only” using a “Hospital Grade” power cord. Potential Equalization Terminal • This terminal can be used to verify compliance with 60601-1. • This terminal is used for connecting dedicated ground leads. Foot Switch Connector This connector is used for the optional Foot Switch. Peristaltic Pump Connector This connector can be used to communicate with the optional MetriQ™ Pump. Remote Connector This connector can be used to communicate with the optional Remote. EP Recording System Connector This connector allows the RF Generator to communicate the ablation parameters to the EP Recording System. Speaker Volume Knob This knob adjusts the volume of the RF Generator audio speaker. 12

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Remote Rear Panel This section describes the connections and controls on the rear panel of the Remote shown in Figure 3.

VA POWER INPUT 25 VA 50/60 Hz Hz FREQUENCY AC VOLTAGE 100-120 / 220-240V

Mains Power Inlet

Separate Collection

Speaker Volume Maestro 4000™ Remote Control

Made In USA: 560 Cottonwood Drive Milpitas, CA 95035 USA

Follow Instructions For Use

C

US

RF Cardiac Ablation Remote Control

cTUVus Mark indicates compliance to UL 60601-1 and CAN/CSA 22.2 601.1 M90 covering electrical safety requirements for the US and Canada.

M00440200 REF

Catalog No. Date of Manufacture

SN

871-0189-000 REV A

Serial Number

4020 YYYY-MM-DD 12345678

Remote Connector

90818619-01A

Equipotentiality Terminal

Mains Power Inlet The Mains Power Inlet must be connected to an AC wall outlet designated as “Hospital Grade” or “Hospital Only” using a “Hospital Grade” power cord. Potential Equalization Terminal • This terminal can be used to verify compliance with 60601-1. • This terminal is used for connecting dedicated ground leads. Remote Control Connector Provides an interface between the Remote and the RF Generator. Speaker Volume Knob This knob adjusts the volume of the Remote audio speaker.

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Figure 3. Remote Rear Panel

Pod Connections This section describes the connectors on the Pod shown in Figure 4. Recording System

Catheter Cable

F

F

Dispersive Pad Connectors Pod to Generator Cable

Figure 4. Pod Connections

Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in Global), Maestro 4000 Cardiac Ablation System Operator’s Manual, Global, 90813738-01E

Standard/High-Power Catheter Connector One nine-pin receptacle labeled “STD/XP” is provided for connection to catheters. Dispersive Pad Connectors • Two male two-pin receptacles are provided for connection to dispersive pads (also known as the dispersive indifferent pads, ground pads, or return pads). • Dispersive pads complete the electrical circuit, allowing RF power to be delivered to the patient. • Connect (2) dispersive pads to the Pod when using high-power catheters. • A single dispersive pad is sufficient when using non-high-power catheters. • The RF Generator will cease RF output to the patient if the current through a dispersive pad exceeds 1.1 amps. • Read the manufacturer’s instructions before installing dispersive pads. EP Recorder Connector Connects the Pod to the EGM pins of the EP Recording System using a BSC Model 653S cable. Pod-to-Generator Cable The Pod-to-Generator cable is used to connect the Pod to the “Isolated Patient Connector” on the front panel of the RF Generator.

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Compatible Catheters • WARNING: Refer to the Directions for Use (DFU) provided with individual catheters to determine if the catheters are compatible with the Maestro 4000™ Cardiac Ablation System. Carefully review the specific indications, contraindications, warnings, precautions and adverse events included in a catheter’s DFU prior to using the catheter with the Maestro 4000 Cardiac Ablation System. Catheters tested for compatibility for use with the Maestro 4000 Cardiac Ablation System include the BSC Models listed below. Note: some catheters may not be available in all geographic areas.

Standard Catheters: • Blazer II™ • Blazer II HTD™ • Blazer Prime™ HTD High-Power Catheters: • Blazer II XP™ • Blazer Prime™ XP • IntellaTip MiFi XP

Open-Irrigated Catheters: • Blazer Open-Irrigated Ablation Catheter The RF Generator recognizes the catheter/pod combination and automatically adjusts the ranges of power and temperature settings available for the selected control mode.

Catheter Type Standard Standard High-Power High-Power Closed-Irrigation Closed-Irrigation Open-Irrigated Open-Irrigated

Table 1 Adjustment Ranges for Power and Temperature Temperature Range Temperature Range Pod Type Temp-Control Mode Power-Control Mode 100W 30 – 90 °C 30 – 95 °C 150W 30 – 90 °C 30 – 95 °C 100W 30 – 80 °C 30 – 85 °C 150W 30 – 90 °C 30 – 95 °C 100W 30 – 90 °C 30 – 95 °C 150W 30 – 90 °C 30 – 95 °C 100W 30 – 50 °C 30 – 50 °C 150W 30 – 50 °C 30 – 50 °C

Maestro 4000™ Cardiac Ablation System Operator’s Manual, Global

Power Range 0 - 50 W 0 - 100 W 0 - 100 W 0 - 150 W 0 - 50 W 0 - 50 W 0 - 50 W 0 - 50 W

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Closed-Irrigation Catheters: • Chilli II Cooled Ablation Catheter

Catheter Cable Configurations and System Interconnections Refer to the Directions for Use (DFU) provided with individual catheters to determine the cable configurations for connecting catheters to the Pod. Front Panel

Rear Panel

Maestro 4000™ Remote

VA POWER INPUT 25 VA 50/60 Hz Hz FREQUENCY AC VOLTAGE 100-120 / 220-240V

Separate Collection

Maestro 4000™ Remote Control

Made In USA: 560 Cottonwood Drive Milpitas, CA 95035 USA

RF Cardiac Ablation Remote Control

Follow Instructions For Use

C

US

M00440200

cTUVus Mark indicates compliance to UL 60601-1 and CAN/CSA 22.2 601.1 M90 covering electrical safety requirements for the US and Canada.

Catalog No.

REF

Date of Manufacture

SN

871-0189-000 REV A

Serial Number

4020 YYYY-MM-DD 12345678

90818619-01A

Generator to Pump Cable

Peristaltic Pump

VA POWER INPUT Hz FREQUENCY AC VOLTAGE

Isolated Patient Connector

W kHz

EP Recording System Cable

Maestro 4000™ Controller RF Cardiac Ablation Controller

50, 100, 150 100 460

M00440000 REF

Catalog No. Date of Manufacture

SN

Serial Number

4000 YYYY-MM-DD 12345678

Made In USA: 560 Cottonwood Drive Milpitas, CA 95035 USA

C

US

cTUVus Mark indicates compliance to UL 60601-1 and CAN/CSA 22.2 601.1 M90 covering electrical safety requirements for the US and Canada.

871-0186-000 REV A

Front Panel

Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in Global), Maestro 4000 Cardiac Ablation System Operator’s Manual, Global, 90813738-01E

300 VA 50/60 Hz 100-120 / 220-240V

RATED OUTPUT POWER RATED LOAD OPERATING FREQUENCY

Pod to Generator Cable

Separate Collection

Follow Instructions For Use

90818618-01A

Rear Panel

Maestro 4000 Controller EGM Cable

Maestro Footswitch Front Panel

MetriQ™ Pump

Rear Panel

1 Mem

Model 4010 100W Pod or Model EPT4010 150WPod

2 Mem

3 Mem

Manual Mode

2

mL/min

mL/min

17

mL/min

1999 mL remaining

30

mL/min

0

Dispersive Pad

Catheter Cable

Open-Irrigated Catheter

MetriQ Footswitch

Figure 5. Maestro 4000 Cardiac Ablation System Connection Guide illustrates optional components. Example includes optional Remote Control, footswitches, MetriQ Pump and typical Open-Irrigated Catheter Read the MetriQ Pump Operators Manual before attempting to operate the MetriQ Pump.

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OPERATION •

• • •

WARNING: Pacemakers, implantable cardioverter/defibrillators, and leads can be adversely affected by radiofrequency energy. It is important to refer to the manufacturer’s instruction for use prior to performing ablation procedures. WARNING: The impedance display of the RF Generator should be continuously monitored during RF power delivery. If a sudden rise in impedance is noted, RF power delivery should be discontinued. WARNING: Failure of the RF Generator could result in an unintended increase of output power. WARNING: The risk of igniting flammable gases or other materials is inherent in the application of RF power and precautions must be taken accordingly. Some materials, for example cotton, wool and gauze, when saturated with oxygen may be ignited by sparks produced in normal use of the HF surgical equipment. Note: Boston Scientific relies on the physician to determine, assess and communicate to the individual patient all foreseeable risks of the cardiac ablation procedure.

Start-Up Turn the RF Generator ON by toggling the Mains Power Switch on the front panel to the “I” position. If a Remote is connected to the RF Generator: • Turn the Remote ON by toggling its Mains Power Switch to the “I” position. • Press the Generator Remote button to activate the Remote Control Panel. The RF Generator and Remote (if applicable) will initiate a self-test. • “SELF TEST” appears on the alphanumeric display, a continuous audio tone is generated for approximately two seconds, and all front panel displays/indicators are lit. • The Pod and a Catheter must be connected to complete the self-test. • If no System malfunction is detected, the RF Control Button will flash to indicate the RF Generator has entered STANDBY state. • If a System malfunction is detected, the RF Generator or Remote (if applicable) will not operate. The red SYSTEM FAULT indicator will be lit. The displays for Power, Temp, Impedance and Time will all read 888. Standby State STANDBY state initiates automatically after System start-up and whenever Deliver state is terminated. Power, Temperature, Impedance, and Time settings may be viewed and adjusted in this state. When STANDBY state is initiated after System start-up: • The default settings shown in Table 2 will appear in the Power, Temperature, Impedance, and Time displays. Table 2. Default Setting for Power, Temperature, Impedance, Time Catheter Type Power Temperature Impedance Standard, High-Power, 0 Watts 30 °C 300Ω Closed-Irrigation Open-Irrigated 0 Watts 50 °C 250Ω • •

Time 0 Sec 0 Sec

Measured impedance and temperature values appear in the alphanumeric display. Ablation count and total time (also in the alphanumeric display) will be reset to zero.

Maestro 4000™ Cardiac Ablation System Operator’s Manual, Global

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This section provides basic operation instructions for the Maestro 4000™ Cardiac Ablation System.

Select RF Delivery Settings Use one of the methods below to select RF Delivery settings for a procedure. • Recall RF Delivery settings stored with the Memory Buttons. • Manually set the RF Delivery settings as described below. Control-Mode Selection • WARNING: With non-irrigated catheters, start with a low temperature setting in temperature-control mode, and then slowly titrate the temperature setting up to achieve the desired effect. With irrigated catheters, select power-control mode with a temperature setting intended to ensure that adequate fluid is irrigating the tip of the catheter. The mode of operation can be toggled between Power-Control Mode and Temperature-Control Mode by pressing the Control Mode Button while the unit is in STANDBY mode (The control mode button is inactive during RF power delivery). The control-mode selection determines the effect of the Power and Temperature settings. • In Power-Control Mode: • The amount of RF power delivered will equal the power setting unless the measured temperature exceeds the temperature setting. • The temperature setting is a limit for catheter tip temperature. If the limit is exceeded, power will be reduced or halted to lower the measured temperature below this limit. Note: When power is reduced or halted, an operational message or diagnostic code will appear in the front panel display. See OPERATIONAL MESSAGES Section, or DIAGNOSTIC MESSAGES Section for additional information.

Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in Global), Maestro 4000 Cardiac Ablation System Operator’s Manual, Global, 90813738-01E

•

In Temperature-Control Mode: • The power setting is a limit. The RF Generator is allowed to adjust RF power delivery up to this limit to achieve the target temperature. • The temperature setting is the target temperature. Note: The target temperature may not be reached if the power setting (limit) is reached.

The default control modes for BSC Catheters are listed in Table 3. When a catheter is initially connected, the RF Generator automatically switches to the default control mode for that catheter. However, the user may switch control modes by pressing the control-mode button.

Table 3. Catheter Default Control Modes Catheter Types Default Control Mode High-Power and Standard Power Temperature Control Open-Irrigated and Closed-Irrigated Power Control

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Power Setting • WARNING: To minimize the potential for thrombus formation, inadvertent damage to cardiac tissues, and collateral damage to adjacent tissue not intended for ablation, begin by using a low power setting and gradually increase the power output if necessary, especially in areas where low blood flow and correspondingly low convective cooling may be present. Temperature Setting • WARNING: To minimize the potential for thrombus formation, inadvertent damage to cardiac tissues, and collateral damage to adjacent tissue not intended for ablation, begin by using a low temperature setting and gradually increase the power output if necessary, especially in areas where high blood flow and correspondingly high convective cooling may be present. • WARNING: The displayed temperature is not the maximum tissue temperature. The measured temperature may be influenced by the degree of tissue contact and variations in blood flow. The difference between the max tissue temperature and the displayed temperature increases when using irrigated catheters, and the correlation with lesion formation is greatly reduced. The temperature displayed with irrigated catheters is not intended to guide lesion formation. The temperature displayed with irrigated catheters is intended to verify that the tip is being sufficiently irrigated. This behavior will minimize the potential for thrombus formation and/or inadvertent damage to nearby tissue. Impedance Setting The impedance upper limit may be adjusted between 150 Ω to 300 Ω.

Selecting Average and Maximum Display Press the “Maximum” and/or “Average” Buttons, if those values are to be displayed. RF Power Delivery with Open-Irrigated BSC Catheters Use of the RF Generator with BSC open-irrigated catheters requires proper set-up and preparation of the MetriQ™ Pump and the MetriQ Irrigation Tubing Set. The MetriQ Pump Operator’s Manual provides complete instructions for set-up and operation of the MetriQ Pump and MetriQ Irrigation Tubing Set . Starting RF Power Delivery: • Press the RF Power Control button once, or hold down the Foot Switch pedal. • The MetriQ Pump will switch from standby flow to ablation flow. • Delivery of RF Power will start when the Pre-RF Delay is complete. • The RF Power Control button will illuminate and remain lit until RF power delivery stops. • RF Power will stop automatically when the setting for maximum duration of RF Power Delivery is reached. • The Pump will switch to standby flow when the Post-RF Delay is complete. Stopping RF Power Delivery: • To stop delivery of RF Power before reaching the setting for maximum duration, press the RF Power Control Button, or release the Foot Switch pedal. • The RF Power Control button will flash to indicate the RF Generator is in STANDBY state. • The Pump will switch to standby flow when the Post-RF Delay is complete.

Maestro 4000™ Cardiac Ablation System Operator’s Manual, Global

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Time Setting Set the timer for the maximum duration of RF Power delivery.

RF Power Delivery with all other Catheters Starting RF Power Delivery: • Press the RF Power Control button once, or hold down the Foot Switch pedal. • Delivery of RF Power will start immediately. • The RF Power Control button will illuminate and remain lit until RF power delivery stops. • RF Power will stop automatically when the setting for maximum duration of RF Power Delivery is reached. Stopping RF Power Delivery: • To stop delivery of RF Power before reaching the setting for maximum duration, press the RF Power Control Button, or release the Foot Switch pedal. • The RF Power Control button will flash to indicate that the RF Generator is in STANDBY state.

SERVICE AND MAINTENANCE

Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in Global), Maestro 4000 Cardiac Ablation System Operator’s Manual, Global, 90813738-01E

Preventative Inspection • WARNING: Damage such as frayed cords or cables and cracks or dents on the equipment may result in electrical shock. • Caution: BSC recommends that the RF Generator and Remote be powered off at the end of each procedure in order to ensure that the self-test is performed before the next procedure. During the useful life of the equipment, maintain close watch for damage such as frayed cords or cables and cracks or dents on the equipment. If damage is identified, take the equipment out of service and contact Boston Scientific Corporation for service requirements. Functional Self-Test System does not require periodic preventative maintenance and calibration. Upon start up, the unit performs self-test per OPERATION Start-up Section of this manual. For further details refer to that section. System Servicing None of the System components are user-serviceable. Contact Boston Scientific Corporation for all service requirements. Cleaning/Disinfecting • WARNING: Do not immerse the Generator, the Remote, or accessories in any liquid. • WARNING: Use of non-flammable cleaning and disinfection agents is recommended. If used, flammable agents or solvents should be allowed to evaporate before high-frequency surgery. There is a risk of pooling of flammable solutions under the PATIENT or in body depressions such as the umbilicus, and in body cavities such as the vagina. Any fluid pooled in these areas should be mopped up before HF SURGICAL EQUIPMENT is used. Caution: The Generator, Pod, Remote, Footswitch, power cords, and communication cables are not intended to be sterilized and should remain outside of the sterile field. The outer surfaces of the Generator, the Pod, the Remote and their accessories may be wiped clean with a mild soapy solution. Isopropyl alcohol may be used to clean the outer surfaces. Avoid caustic or abrasive cleaners. •

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