HALO360 System Technical Manual Rev A

Table of Contents 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13.

INTRODUCTION ... 1 INDICATED USE ... 2 WARNINGS AND PRECAUTIONS... 2 INSTALLATION ... 5 SYSTEM DESCRIPTION ... 8 ENERGY GENERATOR FUNCTIONAL TESTING... 16 TROUBLESHOOTING ... 33 ERROR AND FAULT CODE INTERPRETATION AND TECHNICAL SPECIFICATION ... 34 GUIDANCE AND MANUFACTURER’S DECLARATION- ELECTROMAGNETIC EMISSIONS... 35 MEASUREMENT ACCURACY GRAPHS ... 36 LABELING SYMBOLS AND USER INFORMATION... 39 WARRANTY INFORMATION ... 41 FORMS ... 42

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1.

INTRODUCTION

The system presented in this Technical Manual consists of the HALO360 energy generator with HALO360 output cable, disposable single-use HALO360 ablation catheter, disposable single-use HALO360 sizing balloon, and a HALO360 footswitch. The HALO360 energy generator supplies up to 300 watts of radiofrequency power at 460 kHz in a bipolar mode under power control while continuously monitoring and displaying power, energy density, and balloon inflation pressure. Energy density is displayed to allow equivalent energy delivery to the range of HALO360 ablation catheter diameters available. An inflation/deflation system is also included in the HALO360 energy generator. This Technical Manual provides a description of the energy generator, disposables and accessories. The energy generator consists of seven major subsystems: • Inflation System, • CPU Board, • RF Board, • Pressure Monitoring Board, • RF Mux Board, • CCM Board and • Front Panel Overlay and Display Board. This manual will provide a functional description of each of these components, and will provide information on calibrating, troubleshooting and performing routine maintenance on the energy generator. Observe all warnings in this manual and in the HALO360 System User’s Manual. Failure to do so may result in damage to the equipment or injury to the user or patient. This manual is not intended for service activities. WARNING: All service must be performed by an Authorized Repair Facility. All service or repair questions should be directed to the BÂRRX Medical Customer Service Department. Because the repair of electrosurgical generators requires specialized knowledge and equipment, there are no user serviceable parts within the energy generator. Opening the energy generator enclosure voids all warranties. WARNING: High voltage and power will be present on exposed surfaces during some tests described in this manual. This testing 1

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should only be performed by properly qualified and trained technicians or engineers 2.

INDICATED USE

The HALO360 System (inclusive of the HALO360 Ablation Catheter) is indicated for use in the coagulation of bleeding and non-bleeding sites in the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett’s Esophagus, Dieulafoy Lesions, and Angiodysplasia. 3.

WARNINGS AND PRECAUTIONS

General Warnings And Precautions

! The safe and effective use of RF energy is highly dependent upon factors under the control of the operator. There is no substitute for a properly trained operating room staff. It is important that the operating instructions supplied with the HALO360 System and Ablation Catheter be read, understood and followed before use. Read and understand the HALO360 System users manual and instructions for use. The users manual and instructions for use are referenced and are an integral part of this document. 3.1.

WARNINGS - energy generator

•

Do not operate the energy generator before thoroughly reading and understanding the User’s Manual and instructions for use included with the ablation catheter and sizing balloon.

•

The voltage selector and the power entry module must be set to the same voltage setting to prevent energy generator malfunction and potential instrument damage. The voltage selector is factory set and should not be changed by the user.

•

The energy generator should only be used with BÂRRX Medical approved accessories. The generator must be used only with the supplied AC power cord.

•

Do not remove the cover of the energy generator, as there is a potential for electrical shock. The generator does not contain any user serviceable parts. Refer to authorized personnel for service. Opening the cover of the generator voids all warranties.

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•

Do not use this device in the presence of flammable anesthetics; other flammable gases; near flammable fluids such as skin prepping agents and tinctures; flammable objects; or with oxidizing agents. Observe appropriate fire precautions at all times.

•

Do not use this device in Oxygen enriched atmospheres, Nitrous Oxide (N2O) atmospheres, or in the presence of other oxidizing agents.

•

While using this device during a procedure, the patient should not be allowed to come into direct contact with grounded metal objects such as surgical table frame, the instrument table, etc.

•

When the energy generator is activated, the conducted and radiated electrical fields may interfere with other electrical medical equipment.

•

It is necessary to use a 0.45 micron hydrophobic filter, placed between the pneumatic connector located at the proximal end of both the Sizing balloon and Ablation catheter and the pneumatic connector on the HALO360 Output Cable to ensure fluids are not aspirated into the HALO360 Output Cable in the event of a Catheter leak. If the catheter is used without the filter, and a balloon leak occurs, inspect the clear tubing portion of the connecting cable for traces of fluid. If fluid is detected, discontinue the use of the cable and order a replacement

•

If the Generator displays an E95 or C56 Operational Codes, this is most likely caused by an air leak in the catheter. If the E95 or C56 Operational Codes are observed, under endoscopic visualization, manually deflate the balloon using a syringe and remove and replace the Catheter.

•

Visual endoscopic confirmation of complete balloon deflation must be performed prior to attempting to reposition or remove the Ablation Catheter or Sizing Balloon.

•

Only inflate the Ablation Catheter and Sizing Balloon using the inflation system incorporated into the Energy Generator.

•

Do not deliver RF energy in areas already treated with staples. The presence of metallic staples can disturb the treatment pattern and may lead to complications.

•

Needle monitoring electrodes are not recommended for use with this equipment.

•

Patient monitoring systems used with this equipment should incorporate high frequency current-limiting devices.

•

The output Cable should be placed as to avoid unnecessary contact with patients or leads from other patient-connected equipment.

•

Failure of the RF Generator could result in an unintended power output increase.

•

Place any monitoring electrodes as far as possible from the surgical electrodes when RF Surgical Equipment and physiological monitoring equipment are used simultaneously on the same patient. Page 3 of 43

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• Electrosurgery should be used with caution in the presence of internal or external pacemakers. Interference produced with the use of electrosurgical devices can cause devices such as a pacemaker to enter an asynchronous mode or can block the pacemaker entirely. Consult the pacemaker manufacturer or hospital Cardiology department for further information when use of electrosurgical appliances is planned in patients with cardiac pacemakers. • This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2:2001. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, 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 the manufacturer or field service technician for help.

There are no user-serviceable parts in this device. Refer servicing to qualified BÂRRX personnel by contacting BÂRRX Medical, Inc. (408) 328-7310

3.2.

WARNINGS – Ablation Catheter See HALO360 ablation catheter and HALO360 sizing balloon Instructions For Use

3.3.

WARNINGS – Sizing balloon See HALO360 ablation catheter and HALO360 sizing balloon Instructions for Use

3.4.

PRECAUTIONS - Energy Generator

• CAUTION: This system cannot be used at an elevation greater than 7000 feet or lower than 300 feet below sea level. •

Do not activate the energy generator until the ablation catheter is properly positioned in the patient. Page 4 of 43

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•

The activation tone and light are important safety features. Do not obstruct the activation light. Do not disable the audible tone.

•

Use only the HALO360 footswitch with the energy generator.

•

The MAIN POWER cord of the energy generator MUST be connected to a properly grounded receptacle. Extension cords and/or adapter plugs MUST not be used.

•

Do not wrap the HALO360 output cable around metal objects. Wrapping cables around metal objects may induce hazardous currents. Refer servicing to qualified BÂRRX Medical personnel by contacting BÂRRX Medical, Inc. (408) 328-7310. 4.

INSTALLATION

Inspect the HALO360 energy generator and HALO360 output Cable for any signs of physical damage to the front and/or side panel, chassis, cover, or the cable. If any physical damage is found, DO NOT USE THE UNIT. Contact BÂRRX Medical, Inc. for a replacement. BÂRRX Medical, Inc. must approve all returns. This equipment has been tested and found to comply with the Electromagnetic Compatibility requirements described in IEC 60601-1-2:2001. These limits are designed to provide reasonable protection against harmful electromagnetic interference in a typical medical installation. This equipment generates and can radiate radiofrequency energy and may cause harmful interference to other devices in the vicinity. This interference can be minimized by installation in accordance with the instructions in this manual and in the User’s Manual. If the equipment does cause harmful interference to other devices, this could potentially be reduced by reorienting or relocating the generator or receiving device, increasing the separation between the devices, or connecting the two devices to different power supplies. 4.1.

Preparing the System for Use

The energy generator may be placed on a mounting cart or on any sturdy table or platform. Refer to hospital procedures or local codes for detailed information. Provide at least six inches of space around the sides and top of the energy generator for convection cooling. Under continuous use for extended periods of time, it is normal for the top and rear panel to be warm.

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The output cable can be attached to the generator at the time of initial generator set-up and left connected to the generator. Assure that the two attachment screws are tight before using the generator. 4.2.

Mains Power Cord

The energy generator is shipped with an approved hospital grade mains power cord. The energy generator must be powered from a properly installed, grounded outlet. Do not use extension cords or three-prong to two-prong adapters. The mains power cord assembly should be periodically checked for damaged insulation or connectors. 4.3.

Energy Generator Cleaning and Disinfection Instructions

Use a mild detergent and damp cloth to clean the energy generator cover, front panel, and power cable. The energy generator is not intended to be sterilized. Do not allow fluids to enter the energy generator chassis. The energy generator may be disinfected using a standard hospital alcohol solution applied with a cloth. The Halo360 catheters are used with hydrophilic filters. If the catheter is used without the filter, and a balloon leak occurs, inspect the clear tubing portion of the connecting cable for traces of fluid. If fluid is detected, discontinue the use of the cable and order a replacement.

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HALO360 System Front View with Footswitch

1 -HALO360 Energy Generator 2 -HALO360 Footswitch

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HALO360 Energy Generator Rear View

5.

SYSTEM DESCRIPTION 5.1.

Introduction The energy generator delivers radio frequency energy at 460 kHz in a bipolar mode to the ablation catheter. The energy Generator consists of seven subsystems: • Inflation System, • CPU Board, • RF Board, • Pressure Monitoring Board, • RF Mux Board, • CCM Board and • Front Panel Overlay and Display Board. The operation of these subsystems is described below. 5.1.1. Inflation System Functional Description The inflation system will provide air at 0.27 ATM and 0.51 ATM to allow a consistent inflation pressure for the balloons on the Sizing Page 8 of 43

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balloon and ablation catheter, respectively. The system consists of a DC-powered pneumatic pump, three control valves, a mass airflow meter and three pressure sensors. The pump and control valves allow the system to control the airflow to the balloon to enable the balloon to be inflated, deflated or vented to atmosphere. The physician must use the energy generator inflation system to inflate the sizing balloon and ablation catheter. 0.27 ATM is used as the sizing balloon inflation pressure because: •

A consistent pressure is desirable for physician use and provides consistent balloon diameter measurements.

•

The diameter estimation routine has been optimized using 0.27 ATM as the inflation pressure.

•

0.27 ATM adequately inflates the sizing balloon and protects the surrounding tissue from injury.

0.51 ATM is used as the maximum ablation catheter inflation pressure because: •

A consistent pressure is desirable for physician use and provides consistent

•

0.51 ATM is within the range of pressures used on devices similar to the ablation catheter.

•

0.51 ATM results in a firm and repeatable structure for all balloon sizes.

Following the inflation of the balloon, the balloon is automatically deflated. It is necessary to use a 0.45 micron hydrophobic filter placed between the pneumatic connector located at the proximal end of both the sizing balloon and ablation catheter and the pneumatic connector on the HALO360 output cable to ensure fluids are not aspirated into the HALO360 output cable in the event of a catheter leak. In the rare event that a balloon should leak, the filter may occlude which could require manual deflation of the balloon. 5.1.2.

The CPU Board Functional Description

The CPU Board contains the microcontroller and associated hardware that controls the generator operation. The system software is stored on a flash EEPROM and bootstrap software is contained on a secondary Page 9 of 43

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EEPROM. This bootstrap software allows the processor to operate with sufficient functionality to load new system software into the EEPROM via the RS-232 port. Software upgrades are intended to only be performed by authorized personnel. The CPU Board communicates to all the other subsystems using analog signals, a parallel or an SPI interface. The CPU Board also contains the analog-to-digital conversion circuits that allow the various system operating parameters to be measured. There are three hardware watchdogs located on the CPU Board, two of these control the RF output and the third one controls the relay allowing RF energy to be delivered to the patient. These hardware watchdogs require a periodic strobe signal to be sent from the microcontroller to remain active; in the event that the microcontroller fails to provide these strobe signals (for example, in the event of a processor failure), the watchdogs timeout and disable the RF output and open the RF patient relays. 5.1.3.

The RF Board Functional Description

The RF Board converts the AC line voltage to the therapeutic 460 kHz RF energy to be delivered to the patient, and provides electrical isolation between the AC line voltage and the patient connected parts of the system. The RF Board uses an automatic line voltage selector circuit so that no separate configuration is required for 120 or 240 VAC operation. The RF Board contains sensors that allow measurement of the RF voltage, current and power. These measurements are then used by the processor to calculate the load resistance and impedance and for RF output control. In addition to these sensors, the RF Board contains hardware interlocks that disable the RF output in the event that voltage, current, or power exceed a predefined limit. 5.1.4.

The Pressure Monitoring Board Functional Description

The Pressure Board provides the interface to the mass airflow meter and contains the three pressure sensors. The mass airflow meter provides an analog signal that is proportional to the quantity of airflow per unit time (since it is desired that this Page 10 of 43

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measurement be independent of the pressure, the flow rate is expressed as standard liters/minute). The pressure sensors are connected to a hardware interlock that disables the pump operation in the event that the balloon pressure exceeds a predefined limit. The Pressure Board also contains voltage references that allow the calibration of the circuits to be checked during the power on sequence. 5.1.5.

The RF Mux Board Functional Description

The RF Mux Board provides the hardware interface to the inflation system and the RF delivery system. It includes a number of drivers that convert the low level logic control signals from the processor to drive signals for the inflation system valves, the pump power control and the RF output control relays. It also includes the isolation and detection circuits for the footswitch pedals, and the control circuits for the EEPROM used on the catheters for device identification. The RF Mux Board also contains a Real Time Clock, which allows the procedure time and duration to be recorded on the catheters. This clock is powered by a lithium battery, which has an expected life of ten years, and is not expected to require replacement during the normal service life of the generator. The RF Mux Board also contains a hardware watchdog that disables the pump operation and opens the vent valve if it is not periodically strobed by the processor. Communication to the CPU Board is through the SPI interface on the microcontroller. 5.1.6.

The CCM Board Functional Description

The CCM Board contains the output impedance matching transformer and the control relays that allow the RF energy to be delivered to one of six possible output channels. The impedance matching transformer is required to allow sufficient energy to be delivered to the low loads (1 – 3 ohms) typically encountered when the ablation catheters are used. After passing through the matching transformer, the RF is delivered to one of six channel outputs by the control relays. These relays are driven by the control circuits on the RF Mux Board. Page 11 of 43

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5.1.7.

The Front Panel Overlay and Display Board Functional Description

The Front Panel Overlay includes the dome switches that comprise the front panel user interface. The Display Board contains the seven segment LED displays, the LED display drivers, the LED indicators, the LCD display and the interface for the RF On button. The RF On button is separately mounted on the bezel of the generator.

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120/240 VAC In

Power Inlet Module

120/240 VAC DC Power Supply 5 / ±12 VDC RF Board Control and analog sense CPU Board RF Output Relay control and current sense Display control and switch read

SPI

CCM Board RF Mux Board Display Board and Overlay

Control and analog sense

Catheter Footswitch EEPROM RF Output to Patient (6 Channel and Return)

Isolation Barrier Inlet Valve Analog sense Exhaust Valve

Pressure Board Mass Flow Meter

Vent Valve Pump

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5.2.

Accessories 5.2.1.

Footswitch

The footswitch allows the operator to initiate or cease the delivery of RF energy without using his or her hands. This is a non-sterile device. The footswitch has two operational controls (foot pedals) which duplicate the functions of the RF ON/OFF and the balloon Auto Inflation buttons. The foot pedal operational controls are normally open electromechanical switches, and are wired to the connector. The resistance of the contacts should exceed 1000 ohms when the switch is not activated, and be less than 5 ohms when the switch is activated. The footswitch can be cleaned using a mild detergent and damp cloth, followed by a disinfectant. The footswitch assembly is not intended to be sterilized.

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Sizing Balloon and Ablation Catheters Sizing balloon - A sizing balloon is used for confirmation of esophagus diameter. This allows the user to confirm the diameter of the esophagus without having to use the more costly HALO360 ablation catheter and does not provide a connection to the RF output of the generator. See HALO360 System User’s Manual and HALO360 Sizing balloon Instructions For Use CAUTION: REMOVE COVER FROM THE BALLOON BEFORE CATHETER INSERTION

BALLOON

20

25

65

60

SHAFT

SOFT TIP

4

5.3

DISTAL END ELECTRICAL CONNECTOR

PNEUMATIC CONNECTOR

PROXIMAL END

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Ablation Catheter - The ablation catheter is used to deliver RF energy to the targeted tissue. There are various sizes available which are to be selected by the physician based upon the patient’s anatomy and the diameter measurements obtained during the sizing sequence. See HALO360 System User’s Manual and HALO360 Ablation Catheter Instructions For Use

CAUTION: REMOVE COVER FROM THE BALLOON BEFORE CATHETER INSERTION

ELECTRODE

20

25 60

4

65

SHAFT

SOFT TIP

DISTAL END ELECTRICAL CONNECTOR

PNEUMATIC CONNECTOR

6.

PROXIMAL END

ENERGY GENERATOR FUNCTIONAL TESTING 6.1.1.

Configuration and Operation – a summary of the operation of the system is provided here to assist with troubleshooting and testing. For a more detailed description of the operation, refer to the User’s Manual included with the energy generator and the Instructions For Use included with the ablation catheter and sizing balloon

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6.2.

Power-Up

Plug the Energy Generator into a grounded hospital grade power outlet (extension cords and/or adapter plugs must not be used). Connect the Output Cable to the Energy Generator. Turn the power on using the ON/OFF switch, which is located on the power access module on the rear panel. The Energy Generator will perform a self-test during which a tone will sound, digital displays will show “8”s and all indicators will be ON. Check that all digit segments and indicators illuminate, and that a tone is audible. If any of the segments or indicators fails to light, or if no tone is heard, DO NOT USE the system. Contact BÂRRX Medical, Inc. In five to seven seconds, the self-test will be completed, and the Energy Generator will enter the STANDBY mode with the digital displays registering the default set values. No procedure settings can be entered during the STANDBY mode. If the Energy Generator goes directly into a FAULT mode upon start-up, DO NOT USE the system, and contact BÂRRX Medical, Inc. 6.3.

Catheter Connected

When a Catheter is connected to the Energy Generator, it will recognize the type of Catheter connected and allow activation of System features, accordingly. The procedure settings can be entered during the CATHETER CONNECTED mode. The Energy Generator is designed to produce a continuous power output, up to a desired total delivered energy density. During RF application, the Energy Generator acts to maintain the set power, subject to voltage and current limits. The application of RF power is controlled by the use of the RF ON button, or by the Footswitch. A desired POWER (W) and total ENERGY DENSITY limit (J/cm2) are set. RF power application can be manually terminated with either of these controls, or by other conditions described in this manual. The duration of RF power is always limited by the set ENERGY DENSITY limit settings. 6.4.

Energy Generator Modes

The Energy Generator operates in one of seven modes, POST (SELF-TEST), STANDBY, CATHETER CONNECTED, ACTIVE (RF ON), ABLATION COMPLETE, ERROR, and FAULT. See Figure 3. Page 17 of 43

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6.4.1. Figure 3. State diagram of Energy Generator modes

POST POST OK

POST Fail

STANDBY

Invalid Catheter

Catheter Connected (Read EEPROM)

Sizing / Coagulation Catheter Test Coagulation Catheter

Balloon Inflation Button Pressed

Balloon Inflation Button Pressed

Balloon Inflated

Balloon Inflated

Sizing Routine Performed

Maintain Pressure RF ON/ Footswitch Pressed ACTIVE RF ON Switch Pressed or Footswitch Released and Pressed or Treatment Complete ABLATION COMPLETE

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AC Mains Power Cycle

Any Non-Recoverable Error

ERROR

Any Recoverable Error

RESET Button Pressed

Sizing Catheter

FAULT